Subchapter R—Toxic Substances Control Act

SUBCHAPTER R—TOXIC SUBSTANCES CONTROL ACT

PART 700—GENERAL nism (each being assigned a separate MCAN number by EPA) as a result of a Subparts A–B [Reserved] prenotice agreement with EPA. Consolidated premanufacture notice or Subpart C—Fees consolidated PMN means any PMN submitted to EPA that covers more than Sec. one chemical substance (each being as- 700.40 Purpose and applicability. signed a separate PMN number by 700.41 Radon user fees. 700.43 Definitions. EPA) as a result of a prenotice agree- 700.45 Fee payments. ment with EPA (See 48 FR 21734). 700.49 Failure to remit fees. Exemption application means any application submitted to EPA under sec- AUTHORITY: 15 U.S.C 2625 and 2665, 44 U.S.C. 3504. tion 5(h)(2) of the Act. Exemption notice means any notice SOURCE: 53 FR 31252, Aug. 17, 1988, unless submitted to EPA under § 723.175 of this otherwise noted. chapter. Final product means a new chemical Subparts A–B [Reserved] substance (as ‘‘new chemical substance’’ is defined in § 720.3 of this Subpart C—Fees chapter) that is manufactured by a person for distribution in commerce, or § 700.40 Purpose and applicability. for use by the person other than as an (a) Purpose. The purpose of this sub- intermediate. part is to collect fees from manufactur- Intermediate premanufacture notice or ers, importers, and processors who sub- intermediate PMN means any PMN submit notices and applications to EPA mitted to EPA for a chemical sub- under section 5 of the Toxic Substances stance which is an intermediate (as Control Act (15 U.S.C. 2604) to defray ‘‘intermediate’’ is defined in § 720.3 of part of EPA’s cost of administering the this chapter) in the production of a Act. final product, provided that the PMN (b) Applicability. This subpart applies for the intermediate is submitted to to all manufacturers, importers, and EPA at the same time as, and together processors who submit certain notices with, the PMN for the final product and applications to EPA under section and that the PMN for the intermediate 5 of the Act. identifies the final product and describes the chemical reactions leading § 700.41 Radon user fees. from the intermediate to the final User fees relating to radon pro- product. If PMNs are submitted to EPA ficiency programs authorized under the at the same time for several intermedi- Toxic Substances Control Act appear ates used in the production of a final at 40 CFR part 195. product, each of those is an intermediate PMN if they all identify the [59 FR 13177, Mar. 18, 1994] final product and every other associated intermediate PMN and are sub- § 700.43 Definitions. mitted to EPA at the same time as, Definitions in section 3 of the Act (15 and together with, the PMN for the U.S.C. 2602), as well as definitions con- final product. tained in §§ 704.3, 720.3, and 725.3 of this Joint submitters means two or more chapter, apply to this subpart unless persons who submit a section 5 notice otherwise specified in this section. In together. addition, the following definitions Microbial commercial activity notice or apply: MCAN means any notice for microorga- Consolidated microbial commercial ac- nisms submitted to EPA pursuant to tivity notice or consolidated MCAN section 5(a)(1) of the Act in accordance means any MCAN submitted to EPA with subpart D of part 725 of this chap- that covers more than one microorga- ter.

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Person means a manufacturer, im- (iv) Exemption applications. Persons porter, or processor. shall remit a fee of $2,500 for each ex- Premanufacture notice or PMN means emption application submitted under any notice submitted to EPA pursuant section 5(h)(2) of the Act. to section 5(a)(1)(A) of the Act in ac- (v) Exemption notices. Persons shall cordance with part 720 of this chapter remit a fee of $2,500 for each exemption or § 723.250 of this chapter. notice submitted under § 723.175 of this Section 5 notice means any PMN, con- chapter. solidated PMN, intermediate PMN, sig- (vi) MCAN and consolidated MCAN. nificant new use notice, exemption no- Persons shall remit a fee of $2,500 for tice, exemption application, any MCAN each MCAN or consolidated MCAN sub- or consolidated MCAN submitted under mitted. section 5 of the Act. (c) No fee required. Persons are ex- Significant new use notice means any empt from remitting any fee for sub- notice submitted to EPA pursuant to missions under §§ 720.38, 723.50, and subsection 5(a)(1)(B) of the Act in accord- parts E, F, and G of part 725 of this ance with part 721 of this chapter. chapter. Small business concern means any per- (d) Joint submitters. Joint submitters son whose total annual sales in the per- of a section 5 notice are required to son’s fiscal year preceding the date of remit the appropriate fee identified in the submission of the applicable sec- paragraph (b) of this section for each tion 5 notice, when combined with section 5 notice regardless of the num- those of the parent company (if any), ber of joint submitters for that notice. are less than $40 million. To qualify for the fee identified in paragraph (b)(1) of this section, each [53 FR 31252, Aug. 17, 1988, as amended at 62 joint submitter of a section 5 notice FR 17931, April 11, 1997] must qualify as a small business con- § 700.45 Fee payments. cern under § 700.43. (e) Remittance procedure. (1) Each re- (a) Persons who must pay fees. Persons mittance under this section shall be in submitting a section 5 notice to EPA United States currency and shall be shall remit for each such notice the ap- paid by money order, bank draft, wire propriate fee identified in paragraph transfer, Pay.gov service provided (b) of this section in accordance with through the Department of the Treas- the procedures in paragraph (e) of this ury, or check drawn to the order of the section. Environmental Protection Agency. (b) Fees. Persons shall remit fee pay- (2) Each paper remittance shall be ments to EPA as follows: sent to the Environmental Protection (1) Small business concerns. Small Agency, Washington Finance Center, business concerns shall remit a fee of Toxic Substances Control Act User $100 for each section 5 notice sub- Fees, P.O. Box 979073, St. Louis, MO mitted. 63197–9000. (2) Others. Persons other than small (3) Persons who submit a TSCA sec- business concerns shall remit fees action 5 notice shall place an identifying cording to the type of section 5 notice number and a payment identity num- as follows: ber on the front page of each TSCA sec- (i) Premanufacture notices and consoli- tion 5 notice submitted. The identi- dated premanufacture notices. Persons fying number must include the letters shall remit a fee of $2,500 for each PMN ‘‘TS’’ followed by a combination of 6 or consolidated PMN submitted. numbers (letters may be substituted (ii) Intermediate premanufacture no- for some numbers). The payment iden- tices. Persons shall remit a fee of $1,000 tity number may be a check number, a for each intermediate PMN. However, wire transfer number, or a ‘‘Pay.gov’’ for the PMN for the final product the transaction number used to transmit person shall submit the fee in para- the user fee. The same TS number and graph (b)(2)(i) of this section. the submitter’s name must appear on (iii) Significant new use notices. Per- the corresponding fee remittance under sons shall remit a fee of $2,500 for each this section. If a remittance applies to significant new use notice submitted. more than one TSCA section 5 notice,

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the person shall include the name of the fee specified in 40 CFR 700.45(b).’’ the submitter and a new TS number for under ‘‘CERTIFICATION’’ on page 2 of each TSCA section 5 notice to which the Premanufacture Notice for New the remittance applies, and the amount Chemical Substances (EPA Form 7710– of the remittance that applies to each 25). notice. Any remittance not having the (ii) Each person who remits a fee identifying name and numbers de- identified in paragraph (b)(2) of this scribed in this paragraph will be re- section for an exemption application turned to the remitter. under TSCA section 5(h)(2) shall insert (4)(i) Each person who remits the fee a check mark for the statement, ‘‘The identified in paragraph (b)(1) of this company named in part 1, section A section for a PMN, consolidated PMN, has remitted the fee specified in 40 CFR intermediate PMN, or significant new 700.45(b).’’ in the exemption applica- use notice shall insert a check mark tion. for the statement, ‘‘The company (iii) Each person who remits the fee named in part 1, section A is a small identified in paragraph (b)(2) of this business concern under 40 CFR 700.43 section for an exemption notice under and has remitted a fee of $100 in ac- § 723.175 of this chapter shall include cordance with 40 CFR 700.45(b).’’ under ‘‘CERTIFICATION’’ on page 2 of the the words, ‘‘Each company identified in Premanufacture Notice for New Chem- this notice has remitted a fee of $2,500 ical Substances (EPA Form 7710–25). in accordance with 40 CFR 700.45(b).’’ in (ii) Each person who remits the fee the certification required in identified in paragraph (b)(1) of this § 723.175(i)(1)(x) of this chapter. section for an exemption application (iv) Each person who remits the fee under TSCA section 5(h)(2) shall insert identified in paragraph (b)(1) of this a check mark for the statement, ‘‘The section for a MCAN for a microorga- company named in part 1, section A is nism shall insert a check mark for the a small business concern under 40 CFR statement, ‘‘The company named in 700.43 and has remitted a fee of $100 in part 1, section A is a small business accordance with 40 CFR 700.45(b).’’ in concern under 40 CFR 700.43 and has re- the exemption application. mitted a fee of $100 in accordance with (iii) Each person who remits the fee 40 CFR 700.45(b).’’ in the certification identified in paragraph (b)(1) of this required in § 725.25(b) of this chapter. section for an exemption notice under (f) Fee refunds. EPA will refund any § 723.175 of this chapter shall include fee paid for a section 5 notice whenever the words, ‘‘Each company identified in the Agency determines: this notice is a small business concern (1) That the chemical substance that under 40 CFR 700.43 and has remitted a is the subject of a PMN, intermediate fee of $100 in accordance with 40 CFR PMN, exemption application, or ex- 700.45(b).’’ in the certification required emption notice is not a new chemical in § 723.175(i)(1)(x) of this chapter. substance as of the date of submission (iv) Each person who remits the fee of the notice. identified in paragraph (b)(1) of this (2) In the case of a significant new section for a MCAN for a microorga- use notice, that the notice was not re- nism shall insert a check mark for the quired. statement, ‘‘The company named in (3) The notice is incomplete under ei- part 1, section A is a small business ther § 720.65(c) or 725.33, of this chapter. concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with (4) That as of the date of submission 40 CFR 700.45(b).’’ in the certification of the notice: the microorganism that required in § 725.25(b) of this chapter. is the subject of a MCAN is not a new (5)(i) Each person who remits a fee microorganism; nor is the use involv- identified in paragraph (b)(2) of this ing the microorganism a significant section for a PMN, consolidated PMN, new use. intermediate PMN, or significant new [53 FR 31252, Aug. 17, 1988, as amended at 54 use notice shall insert a check mark FR 21429, May 18, 1989; 58 FR 34204, June 23, for the statement, ‘‘The company 1993; 62 FR 17932, April 11, 1997; 75 FR 784, named in part 1, section A has remitted Jan. 6, 2010]

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§ 700.49 Failure to remit fees. Administrator and to the person who is EPA will not consider a section 5 no- alleged to have committed the viola- tice to be complete unless the appro- tion. No civil action may be com- priate certification under § 700.45(e) is menced by a citizen to compel the Ad- included and until the appropriate re- ministrator to perform any non-discre- mittance under § 700.45(b) has been sent tionary act or duty under TSCA, unless to EPA as provided in § 700.45(e) and re- at least 60 days in advance the citizen ceived by EPA. EPA will notify the has given notice of the intent to file submitter that the section 5 notice is suit to the Administrator. However, in incomplete in accordance with the case of an alleged failure by the §§ 720.65(c) and 725.33 of this chapter. Administrator to file an action under section 7 of TSCA, the citizen must [62 FR 17932, April 11, 1997] give notice to the Administrator only 10 days in advance of filing the civil ac- PART 702—GENERAL PRACTICES tion. AND PROCEDURES (b) Method of service. Notice of intent to file suit can be either personally Subparts A–B [Reserved] served or served by certified mail—return receipt requested—to persons Subpart C—Citizen Suit identified in paragraph (d) of this sec- Sec. tion. 702.60 Purpose. (c) Date of service. The effective date 702.61 Service of notice. of service of a notice given in accord- 702.62 Contents of notice. ance with this rule shall be the date of AUTHORITY: 15 U.S.C. 2619. the return receipt, if served by mail, or the date of receipt if personally served. SOURCE: 47 FR 2773, Jan. 19, 1982, unless (d) Persons to be served—(1) Violations otherwise noted. of TSCA rules or TSCA order. (i) If the alleged violator is a private individual Subparts A–B [Reserved] or a corporation, notice of intent to file suit shall be served on the indi- Subpart C—Citizen Suit vidual or the owner or managing agent of the plant, facility, or activity al- § 702.60 Purpose. leged to be in violation. If the alleged Section 20 of the Toxic Substances violator is a corporation, a copy of the Control Act (TSCA) authorizes any per- notice shall also be sent to the reg- son to begin a civil action to compel istered agent, if any, of such corpora- performance by the Environmental tion in the State in which such viola- Protection Agency (EPA) of TSCA non- tion is alleged to have occurred. Notice discretionary acts or duties (section shall also be served on the Adminis- 20(a)(2)) or to restrain any violation of trator of the EPA. TSCA, or of any rule promulgated (ii) If the alleged violator is a State under sections 4, 5, or 6, or of any order or local government entity, notice of issued under section 5 of TSCA (section intent to file suit shall be served on the 20(a)(1)). The purpose of this regulation head of the agency. Notice shall also be is to prescribe procedures governing served on the Administrator of the the giving of a notice of intent to file EPA, and a copy shall be sent to the suit required by section 20(b) of TSCA Attorney General of the United States. as a prerequisite to beginning such (iii) If the alleged violator is a Fed- civil actions. eral agency, notice of intent to file suit shall be served on the head of the agen- § 702.61 Service of notice. cy. Notice shall also be served on the (a) Notice as a prerequisite to suit. Administrator of the EPA, and a copy Under section 20 of TSCA, no civil ac- shall be sent to the Attorney General tion may be commenced by a citizen to of the United States. restrain a violation of TSCA, or a rule (2) Performance of non-discretionary or order thereunder, unless at least 60 TSCA acts or duties. Notice of intent to days in advance the citizen has given file suit shall be served on the Admin- notice of the intent to file suit to the istrator of the EPA and a copy shall be

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sent to the Attorney General of the PART 704—REPORTING AND United States. RECORDKEEPING REQUIREMENTS (3) Address of persons to be served. (i) EPA Administrator: 1200 Pennsylvania Subpart A—General Reporting and Rec- Ave., NW., Washington, DC 20460. (ii) ordkeeping Provisions for Section 8(a) Attorney General of the United States: Information-Gathering Rules 10th and Constitution Avenue, NW., Washington, DC 20530. Sec. 704.1 Scope. § 702.62 Contents of notice. 704.3 Definitions. 704.5 Exemptions. (a) Violation of TSCA rule or TSCA 704.7 Confidential business information order. Notice of intent to file suit re- claims. garding an alleged violation of TSCA 704.9 Where to send reports. or any rule promulgated under sections 704.11 Recordkeeping. 4, 5, or 6, or an order issued under sec- 704.13 Compliance and enforcement. tion 5, shall include sufficient information to permit the recipient to identify: Subpart B—Chemical-Specific Reporting and Recordkeeping Rules (1) The specific provision of TSCA or of the rule or order under TSCA alleged 704.25 11-Aminoundecanoic acid. to have been violated. 704.33 P-tert-butylbenzoic acid (P-TBBA), p- (2) The activity alleged to constitute tert-butyltoluene (P-TBT) and p-tert- a violation. butylbenzaldehyde (P-TBB). 704.43 Chlorinated naphthalenes. (3) The person or persons responsible 704.45 Chlorinated terphenyl. for the alleged violation. 704.95 Phosphonic acid, [1,2-ethanediyl- (4) The location of the alleged viola- bis[nitrilobis-(methylene)]]tetrakis- tion. (EDTMPA) and its salts. (5) The date or dates of the alleged 704.102 Hexachloronorbornadiene. violation as closely as the citizen is 704.104 Hexafluoropropylene oxide. able to specify them. 704.175 4,4′-methylenebis(2-chloroaniline) (MBOCA). (6) The full name, address, and telephone number of the citizen giving no- AUTHORITY: 15 U.S.C. 2607(a). tice. (b) Failure to act. Notice regarding an Subpart A—General Reporting alleged failure of the Administrator to and Recordkeeping Provisions perform any act or duty which is not for Section 8(a) Information- discretionary shall: Gathering Rules (1) Identify the specific provision of TSCA which requires an act or creates § 704.1 Scope. a duty. (a) This part specifies reporting and (2) Describe with reasonable speci- recordkeeping procedures under sec- ficity the action taken or not taken by tion 8(a) of the Toxic Substances Con- the Administrator which is alleged to trol Act (TSCA) for manufacturers, im- constitute a failure to perform the act porters, and processors of chemical or duty. substances and mixtures (hereafter col- (3) State the full name, address, and lectively referred to as substances) telephone number of the citizen giving that are identified in subpart B of this the notice. part. The reporting and recordkeeping (c) Identification of Counsel. The no- provisions in subpart A of this part tice shall state the name, address, and apply throughout this part unless re- telephone number of the Legal Counsel, vised in any other subpart. if any, representing the citizen giving (b) Subpart B of this part sets out the notice. chemical-specific reporting and recordkeeping requirements under section 8(a) of TSCA. [53 FR 51715, Dec. 22, 1988, as amended at 60 FR 31920, June 19, 1995]

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§ 704.3 Definitions. inadvertent, or emergency pressure re- All definitions as set forth in section lief releases remains an enclosed proc- 3 of TSCA apply in this part. In addi- ess so long as measures are taken to tion, the following definitions are pro- prevent worker exposure to and envi- vided for the purposes of this part. ronmental contamination from the re- Annual means the corporate fiscal leases. year. EPA means the United States Envi- Article means a manufactured item ronmental Protection Agency. (1) which is formed to a specific shape Import means to import for commer- or design during manufacture, (2) cial purposes. which has end use function(s) depend- Import for commercial purposes means ent in whole or in part upon its shape to import with the purpose of obtain- or design during end use, and (3) which ing an immediate or eventual commer- has either no change of chemical com- cial advantage for the importer, and in- position during its end use or only cludes the importation of any amount those changes of composition which of a chemical substance or mixture. If have no commercial purpose separate a chemical substance or mixture con- from that of the article, and that retaining impurities is imported for com- sult from a chemical reaction that oc- mercial purposes, then those impuri- curs upon end use of other chemical ties also are imported for commercial substances, mixtures, or articles; ex- purposes. cept that fluids and particles are not Import in bulk form means to import a considered articles regardless of shape chemical substance (other than as part or design. of a mixture or article) in any quan- Byproduct means a chemical sub- tity, in cans, bottles, drums, barrels, stance produced without a separate packages, tanks, bags, or other con- commercial intent during the manufac- tainers, if the chemical substance is in- ture, processing, use, or disposal of an- tended to be removed from the con- other chemical substance(s) or mix- tainer and the substance has an end use ture(s). or commercial purpose separate from CAS Number means Chemical Ab- the container. stracts Service Registry Number. Importer means (1) any person who Coproduct means a chemical sub- imports any chemical substance or any stance produced for a commercial pur- chemical substance as part of a mix- pose during the manufacture, proc- ture or article into the customs terri- essing, use, or disposal of another tory of the United States, and includes: chemical substance or mixture. (i) The person primarily liable for the Customer means any person to whom payment of any duties on the merchan- a manufacturer, importer, or processor dise, or directly distributes any quantity of a (ii) An authorized agent acting on his chemical substance, mixture, mixture behalf (as defined in 19 CFR 1.11). containing the substance or mixture, or article containing the substance or (2) Importer also includes, as appro- mixture, whether or not a sale is in- priate: volved. (i) The consignee. Domestic means within the geo- (ii) The importer of record. graphical boundaries of the 50 United (iii) The actual owner if an actual States, including the District of Co- owner’s declaration and superseding lumbia, the Commonwealth of Puerto bond have been filed in accordance Rico, the Virgin Islands, Guam, Amer- with 19 CFR 141.20. ican Samoa, the Northern Mariana Is- (iv) The transferee, if the right to lands, and any other territory or pos- draw merchandise in a bonded ware- session of the United States. house has been transferred in accord- Enclosed process means a manufac- ance with subpart C of 19 CFR part 144. turing or processing operation that is (3) For the purposes of this defini- designed and operated so that there is tion, the customs territory of the no intentional release into the environ- United States consists of the 50 States, ment of any substance present in the Puerto Rico, and the District of Colum- operation. An operation with fugitive, bia.

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Impurity means a chemical substance it is manufactured, including the reac- which is unintentionally present with tion vessel in which it is manufactured, another chemical substance. equipment which is ancillary to the re- Intermediate means any chemical sub- action vessel, and any equipment stance that is consumed, in whole or in through which the substance passes part, in chemical reactions used for the during a continuous flow process, but intentional manufacture of other not including tanks or other vessels in chemical substances or mixtures, or which the substance is stored after its that is intentionally present for the manufacture. Mechanical or gravity purpose of altering the rates of such transfer through a closed system is not chemical reactions. considered to be intentional removal, Known to or reasonably ascertainable but storage or transfer to shipping con- by means all information in a person’s tainers ‘‘isolates’’ the substance by re- possession or control, plus all informa- moving it from process equipment in tion that a reasonable person similarly which it is manufactured. situated might be expected to possess, Own or control means ownership of 50 control, or know. percent or more of a company’s voting Manufacture means to manufacture stock or other equity rights, or the for commercial purposes. power to control the management and Manufacture for commercial purposes policies of that company. A company means: (1) To import, produce, or man- may own or control one or more sites. ufacture with the purpose of obtaining A company may be owned or controlled an immediate or eventual commercial by a foreign or domestic parent com- advantage for the manufacturer, and pany. includes among other things, such Parent company is a company that ‘‘manufacture’’ of any amount of a owns or controls another company. chemical substance or mixture: Person includes any individual, firm, (i) For commercial distribution, in- company, corporation, joint venture, cluding for test marketing. partnership, sole proprietorship, asso- (ii) For use by the manufacturer, in- ciation, or any other business entity; cluding use for product research and any State or political subdivision development, or as an intermediate. thereof; any municipality; any inter- (2) Manufacture for commercial pur- state body; and any department, agen- poses also applies to substances that cy, or instrumentality of the Federal are produced coincidentally during the Government. manufacture, processing, use, or dis- Possession or control means in the pos- posal of another substance or mixture, session or control of any person, or of including both byproducts that are sep- any subsidiary, partnership in which arated from that other substance or the person is a general partner, parent mixture and impurities that remain in company, or any company or partner- that substance or mixture. Such by- ship which the parent company owns or products and impurities may, or may controls, if the subsidiary, parent com- not, in themselves have commercial pany, or other company or partnership value. They are nonetheless produced is associated with the person in the re- for the purpose of obtaining a commer- search, development, test marketing, cial advantage since they are part of or commercial marketing of the sub- the manufacture of a chemical product stance in question. Information is in for a commercial purpose. the possession or control of a person if Manufacturer means a person who im- it is: ports, produces, or manufactures a (1) In the person’s own files including chemical substance. A person who ex- files maintained by employees of the tracts a component chemical substance person in the course of their employ- from a previously existing chemical ment. substance or a complex combination of (2) In commercially available data substances is a manufacturer of that bases to which the person has pur- component chemical substance. chased access. Non-isolated intermediate means any (3) Maintained in the files in the intermediate that is not intentionally course of employment by other agents removed from the equipment in which of the person who are associated with

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research, development, test marketing, of reporting on the production or im- or commercial marketing of the chem- portation of that substance at that ical substance in question. site, unless the manufacturer or im- Process means to process for commer- porter qualifies as small under stand- cial purposes. ard (2) of this definition. Process for commercial purposes means (2) Second standard. A manufacturer the preparation of a chemical sub- or importer of a substance is small if stance or mixture after its manufac- its total annual sales, when combined ture for distribution in commerce with with those of its parent company (if the purpose of obtaining an immediate any), are less than $4 million, regard- or eventual commercial advantage for less of the quantity of substances pro- the processor. Processing of any duced or imported by that manufac- amount of a chemical substance or turer or importer. mixture is included in this definition. (3) Inflation index. EPA shall make If a chemical substance or mixture containing impurities is processed for use of the Producer Price Index for commercial purposes, then the impuri- Chemicals and Allied Products, as com- ties also are processed for commercial piled by the U.S. Bureau of Labor Sta- purposes. tistics, for purposes of determining the Processor means any person who proc- need to adjust the total annual sales esses a chemical substance or mixture. values and for determining new sales Production volume means the quantity values when adjustments are made. of a substance which is produced by a EPA may adjust the total annual sales manufacturer, as measured in kilo- values whenever the Agency deems it grams or pounds. necessary to do so, provided that the Propose to manufacture, import, or Producer Price Index for Chemicals process means that a person has made a and Allied Products has changed more firm management decision to commit than 20 percent since either the most financial resources for the manufac- recent previous change in sales values ture, import, or processing of a speci- or the date of promulgation of this fied chemical substance or mixture. rule, whichever is later. EPA shall pro- Site means a contiguous property vide FEDERAL REGISTER notification unit. Property divided only by a public when changing the total annual sales right-of-way shall be considered one values. site. There may be more than one plant Small quantities solely for research and on a single site. The site for a person development (or ‘‘small quantities sole- who imports a substance is the site of ly for purposes of scientific experimen- the operating unit within the person’s tation or analysis or chemical research organization which is directly respon- on, or analysis of, such substance or sible for importing the substance and another substance, including such re- which controls the import transaction search or analysis for the development and may in some cases be the organiza- of a product’’) means quantities of a tion’s headquarters office in the United chemical substance manufactured, im- States. ported, or processed or proposed to be Small manufacturer or importer means a manufacturer or importer that meets manufactured, imported, or processed either of the following standards: solely for research and development (1) First standard. A manufacturer or that are not greater than reasonably importer of a substance is small if its necessary for such purposes. total annual sales, when combined with Substance means either a chemical those of its parent company (if any), substance or mixture unless otherwise are less than $40 million. However, if indicated. the annual production or importation Test marketing means the distribution volume of a particular substance at in commerce of no more than a pre- any individual site owned or controlled determined amount of a chemical sub- by the manufacturer or importer is stance, mixture, article containing greater than 45,400 kilograms (100,000 that chemical substance or mixture, or pounds), the manufacturer or importer a mixture containing that substance, shall not qualify as small for purposes by a manufacturer or processor, to no

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more than a defined number of poten- esses, or proposes to manufacture, im- tial customers to explore market capa- port, or process a substance identified bility in a competitive situation during in this part only in small quantities a predetermined testing period prior to solely for research and development is the broader distribution of that chem- exempt from the reporting require- ical substance, mixture, or article in ments of this part. commerce. (f) Small manufacturers and importers. Total annual sales means the total an- Small manufacturers and importers are nual revenue (in dollars) generated by exempt from the reporting require- the sale of all products of a company. ments of this part. Total annual sales must include the total annual sales revenue of all sites [53 FR 51717, Dec. 22, 1988] owned or controlled by that company and the total annual sales revenue of § 704.7 Confidential business information claims. that company’s subsidiaries and foreign or domestic parent company, if (a) Any person submitting a notice any. under this rule may assert a business TSCA means the Toxic Substances confidentiality claim covering all or Control Act, 15 U.S.C. 2601 et seq. any part of the notice. Any information covered by a claim will be dis- [53 FR 51715, Dec. 22, 1988] closed by EPA only to the extent and § 704.5 Exemptions. by means of the procedures set forth in part 2 of this title. A person who is subject to reporting (b) If no claim accompanies the no- requirements for a substance identified tice at the time it is submitted to EPA, in this part is exempt from those re- the notice will be placed in an open file quirements to the extent that the per- available to the public without further son and that person’s use of the sub- notice to the respondent. stance is described in this section. This section is superseded by any TSCA sec- (c) To assert a claim of confiden- tion 8(a) rule that adds to, removes, or tiality for data contained in a notice, revises the exemptions described in the respondent must submit two copies this section. of the notice. (a) Articles. A person who imports, (1) One copy of the notice must be processes, or proposes to import or complete. In that copy the respondent process a substance identified in this must indicate what data, if any, are part solely as part of an article is ex- claimed as confidential by marking the empt from the reporting requirements specific information on each page with of this part with regard to that sub- a label such as ‘‘confidential’’, ‘‘pro- stance. prietary’’, or ‘‘trade secret’’. (b) Byproducts. A person who manu- (2) If some data in the notice are factures, imports, or proposes to manu- claimed as confidential, the respondent facture or import a substance identi- must submit a second copy. The second fied in this part solely as a byproduct copy must be complete except that all is exempt from the reporting require- information claimed as confidential in ments of this part. the first copy must be deleted. (c) Impurities. A person who manufac- (3) The first copy of the notice will be tures, imports, processes, or proposes for internal use by EPA. The second to manufacture, import, or process a copy will be placed in an open file to be substance identified in this part solely available to the public. as an impurity is exempt from the re- (4) Failure to furnish a second copy porting requirements of this part. of the notice when information is (d) Non-isolated intermediate. A person claimed as confidential in the first who manufactures or proposes to man- copy will be considered a presumptive ufacture a substance identified in this waiver of the claim of confidentiality. part solely as a non-isolated inter- EPA will notify the respondent by cer- mediate is exempt from the reporting tified mail that a finding of a presump- requirements of this part. tive waiver of the claim of confiden- (e) Research and development. A per- tiality has been made. The respondent son who manufactures, imports, proc- has 15 days from the date of receipt of

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notification to submit the required sec- (d) All return receipts signed by the ond copy. Failure to submit the second person’s customers who received the copy will cause EPA to place the first notice described in paragraph (c) of copy in the public file. this section. (d) In submitting a claim of confidentiality, a person attests to the truth of [53 FR 51717, Dec. 22, 1988, as amended at 58 FR 34204, June 23, 1993] the following four statements concerning all information which is § 704.13 Compliance and enforcement. claimed confidential: (1) My company has taken measures Violators of the requirements of this to protect the confidentiality of the in- part may be subject to civil adminis- formation, and it intends to continue trative penalties up to $25,000 per day to take such measures. of violation or criminal prosecution, as (2) The information is not, and has provided in sections 15 and 16 of TSCA. not been, reasonably obtainable with- In addition, under section 17, EPA may out our consent by other persons (other seek judicial relief to compel submis- than government bodies) by use of le- sion of required information. gitimate means (other than discovery [53 FR 51717, Dec. 22, 1989] based on a showing of special need in a judicial or quasi-judicial proceeding). (3) The information is not publicly Subpart B—Chemical-Specific Re- available elsewhere. porting and Recordkeeping (4) Disclosure of the information Rules would cause substantial harm to our competitive position. § 704.25 11-Aminoundecanoic acid. [48 FR 23420, May 25, 1983, as amended at 53 (a) Definitions. (1) 11–AA means the FR 51717, Dec. 22, 1988] chemical substance 11- aminoundecanoic acid, CAS Number § 704.9 Where to send reports. 2432–99–7. Reports must be submitted by cer- (2) Enclosed process means a process tified mail to the Document Control that is designed and operated so that Office (DCO) (7407M), Office of Pollu- there is no intentional release of any tion Prevention and Toxics (OPPT), substance present in the process. A Environmental Protection Agency, 1200 process with fugitive, inadvertent, or Pennsylvania Ave., NW., Washington, emergency pressure relief releases re- DC 20460–0001, ATTN: 8(a) Reporting. mains an enclosed process so long as measures are taken to prevent worker [60 FR 34463, July 3, 1995, as amended at 71 FR 33641, June 12, 2006] exposure to an environmental contamination from the releases. § 704.11 Recordkeeping. (3) Internal subunit means a subunit Each person who is subject to the re- that is covalently linked to at least porting requirements of this part must two other subunits. Internal subunits of retain the following records for 3 years polymer molecules are chemically de- following the creation or compilation rived from monomer molecules that of the record. have formed covalent links between (a) A copy of each report submitted two or more other molecules. by the person in response to the re- (4) Monomer means a chemical sub- quirements of this part. stance that has the capacity to form (b) Materials and documentation suf- links between two or more other mol- ficient to verify or reconstruct the val- ecules. ues submitted in the report. (5) Polymer means a chemical sub- (c) A copy of each notice sent by the stance that consists of at least a sim- person, return receipt requested, to ple weight majority of polymer mol- that person’s customers for the purpose ecules but consists of less than a sim- of notifying their customers of the cus- ple weight majority of molecules with tomer’s reporting obligations under the same molecular weight. Collec- this part. tively, such polymer molecules must

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be distributed over a range of molec- (ii) For use as a component in ular weights wherein differences in mo- photoprocessing solutions. lecular weight are primarily attrib- (2) Persons who import or propose to utable to differences in the number of import 11–AA: internal subunits. (i) For use as an intermediate in the (6) Polymer molecule means a molecule manufacture of polymers in an en- which includes at least four covalently closed process when it is expected that linked subunits, at least two of which the 11–AA will be fully polymerized are internal subunits. during the manufacturing process, or (7) Small processor means a processor (ii) For use as a component in that meets either the standard in para- photoprocessing solutions. graph (a)(7)(i) of this section or the (3) Persons who process or propose to standard in paragraph (a)(7)(ii) of this process 11–AA: section. (i) For use as an intermediate in the (i) First standard. A processor of a manufacture of polymers in an en- chemical substance is small if its total closed process when it is expected that annual sales, when combined with the 11–AA will be fully polymerized those of its parent company, if any, are during the manufacturing process, or less than $40 million. However, if the (ii) For use as a component in annual processing volume of a par- photoprocessing solutions. ticular chemical substance at any indi- (c) Persons not subject to this section. vidual site owned or controlled by the The following persons are not subject processor is greater than 45,400 kilo- to this section: grams (100,000 pounds), the processor (1) Small manufacturers (includes shall not qualify as small for purposes importers) as described in § 704.3. of reporting on the processing of that (2) Small processors. chemical substance at that site, unless (3) Persons described in § 704.5. the processor qualifies as small under (4) Persons who, at any time during paragraph (a)(7)(ii) of this section. the 3-year period ending July 22, 1986, (ii) Second standard. A processor of a manufactured, imported, or processed chemical substance is small if its total 11–AA: annual sales, when combined with (i) For use as an intermediate in the those of its parent company (if any), manufacture of polymers in an en- are less than $4 million, regardless of closed process when it is expected that the quantity of the particular chemical the 11–AA will be fully polymerized substance processed by that company. during the manufacturing process, or (iii) Inflation index. EPA will use the (ii) For use as a component in Inflation Index described in the defini- photoprocessing solutions. tion of small manufacturer set forth in (d) What information to report. Persons § 704.3, for purposes of adjusting the identified in paragraph (b) of this sec- total annual sales values of this small tion must submit a Premanufacture processor definition. EPA will provide Notice Form (EPA Form 7710–25). notice in the FEDERAL REGISTER when (e) When to report. (1) Persons who in- changing the total annual sales values tend to manufacture, import, or proc- of this definition. ess 11–AA for use as an intermediate in (8) Subunit means an atom or group the manufacture of polymers in an en- of associated atoms chemically derived closed process when it is expected that from corresponding reactants. the 11–AA will be fully polymerized (b) Persons who must report. Except as during the manufacturing process or provided in paragraph (c) of this sec- for use as a component in tion, the following persons are subject photoprocessing solutions must notify to this section: EPA within 30 days after making a (1) Persons who manufacture or pro- firm management decision to commit pose to manufacture 11–AA: financial resources for the manufac- (i) For use as an intermediate in the turing, importing, or processing of 11– manufacture of polymers in an en- AA. closed process when it is expected that (2) Persons who initiated manufac- the 11–AA will be fully polymerized turing, importing, or processing of 11– during the manufacturing process, or AA for use as an intermediate in the

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manufacture of polymers in an en- shall not qualify as small for purposes closed process when it is expected that of reporting on the processing of that the 11–AA will be fully polymerized chemical substance at that site, unless during the manufacturing process, or the processor qualifies as small under for use as a component in paragraph (a)(1)(ii) of this section. photoprocessing solutions during the (ii) Second standard. A processor of a time period between July 22, 1986 and chemical substance is small if its total July 13, 1987 must notify EPA by Au- annual sales, when combined with gust 10, 1987. those of its parent company (if any), (f) Recordkeeping. Persons subject to are less than $4 million, regardless of the reporting requirements of this sec- the quantity of the particular chemical tion must retain documentation of in- substance processed by that company. formation contained in their reports (iii) Inflation index. EPA shall use the for a period of 5 years from the date of Inflation Index described in the defini- submission of the report. tion of small manufacturer that is set (g) Where to send reports. Reports forth in § 704.3, for purposes of adjust- must be submitted by certified mail to ing the total annual sales values of this the Document Control Office (DCO) small processor definition. EPA shall (7407M), Office of Pollution Prevention provide FEDERAL REGISTER notification and Toxics (OPPT), Environmental when changing the total annual sales Protection Agency, 1200 Pennsylvania values of this definition. Ave., NW., Washington, DC 20460–0001, (b) Persons who must report. Except as ATTN: 11–AA Notification. provided in paragraph (c) of this section, the following persons are subject [52 FR 19864, May 28, 1987, as amended at 60 FR 16308, Mar. 29, 1995; 60 FR 34463, July 3, to the reporting requirements of this 1995; 71 FR 33641, June 12, 2006] rule; a person may become subject to this rule more than once, for more § 704.33 P-tert-butylbenzoic acid (P- than one substance or under more than TBBA), p-tert-butyltoluene (P-TBT) one of the criteria listed in this para- and p-tert-butylbenzaldehyde (P- graph (b). TBB). (1) Persons who manufactured, im- (a) Definitions. (1) P-TBBA means the ported, or processed P-TBBA, P-TBT, substance p-tert-butylbenzoic acid, and/or P-TBB for commercial purposes also identified as 4-(1,1- during the person’s latest complete dimethylethyl)benzoic acid, CAS No. corporate fiscal year prior to June 25, 98–73–7. 1986. For purposes of this provision, (2) P-TBT means the substance p- processors of P-TBBA, P-TBT, and/or tert-butyltoluene, also identified as 1- P-TBB shall include only those persons (1,1-dimethylethyl)-4-methylbenzene, who processed the substances other CAS No. 98–51–1. than as non-isolated intermediates. (3) P-TBB means the substance p- (2) Persons who commence manufac- tert-butylbenzaldehyde, also identified ture or importation of P-TBBA, P-TBT, as 4-(1,1-dimethylethyl)benzaldehyde, and/or P-TBB for commercial purposes CAS No. 939–97–9. after June 25, 1986. This provision is ap- (4) Small processor means a processor plicable to persons who cease manufac- that meets either the standard in para- ture or importation of P-TBBA, P-TBT, graph (a)(4)(i) of this section or the and/or P-TBB after June 25, 1986 and standard in paragraph (a)(4)(ii) of this then subsequently resume manufacture section. or importation of the substance(s). (i) First standard. A processor of a (3) Persons who process P-TBBA, P- chemical substance is small if its total TBT, and/or P-TBB for commercial annual sales, when combined with purposes in any way other than as a those of its parent company, if any, are non-isolated intermediate after June less than $40 million. However, if the 25, 1986. annual processing volume of a par- (c) Persons not subject to this rule. In ticular chemical substance at any indi- addition to the persons described in vidual site owned or controlled by the § 704.5, small processors, as defined in processor is greater than 45,400 kilo- paragraph (a)(4) of this section, are not grams (100,000 pounds), the processor subject to this rule.

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(d) Information to report. Persons sub- (ii) A narrative description of the ject to this rule as described in para- manufacturing, importing, or proc- graph (b) of this section shall report in- essing operation(s) involving P-TBBA, formation to EPA as specified in this P-TBT, or P-TBB at each site. paragraph (d). Respondents to this rule (iii) A narrative description of work- shall report all information that is er activities involving P-TBBA, P-TBT, known to or reasonably ascertainable or P-TBB at each site, including the by the person reporting. For purposes number of workers potentially exposed of importer reporting under this para- to each substance and, if applicable, graph, a site is the operating unit with- the number of workers potentially ex- in the person’s organization which is posed to more than one substance. directly responsible for importing the (iv) The potential routes of worker substance and which controls the im- exposure to P-TBBA, P-TBT, or P-TBB port transaction. The import site may at each site (e.g., inhalation, ingestion, in some cases be the organization’s dermal absorption). headquarters office in the United (v) Available monitoring data from States. employee breathing zones with poten- (1) All manufacturers, importers, and tial exposure to P-TBBA, P-TBT, or P- processors specified in paragraph (b) of TBB at each site, including a descrip- this section shall report their name tion of the method of monitoring, the and headquarters address. number of samples taken, and the po- (2) All manufacturers, importers, and tential number of workers similarly processors specified in paragraph (b) of exposed for each worker job category. this section shall report the name, ad- Respondents to this paragraph (d)(4)(v) dress, and office telephone number (in- shall submit data showing a range of 8- cluding area code) of their principal hour time weighted averages (TWAs), technical contact. provided that the data are available in (3) All manufacturers, importers, and that form. Respondents also shall sub- processors specified in paragraph (b) of mit a calculated geometric mean of this section shall report the name and these data, with an explanation of the address of each site where P-TBBA, P- method by which the mean was de- TBT, and/or P-TBB is manufactured, rived. However, if the monitoring data imported, or processed. are not available in the form of 8-hour (4) All manufacturers, importers, and TWAs, respondents shall submit raw processors specified in paragraph (b)(1) sample data results and the duration of this section only shall report the in- time of sampling for each job category. formation described in this paragraph (vi) A narrative description of any (d)(4). Respondents to this paragraph personal protective equipment and/or (d)(4) shall report separately for each engineering controls used to prevent substance that they manufacture, im- exposure to P-TBBA, P-TBT, or P-TBB port, or process, and for each site at at each site. which they do so. However, if the infor- (vii) A listing of the estimated quan- mation to be reported in response to tities of P-TBBA, P-TBT, or P-TBB re- this paragraph (d)(4) is the same for leased directly into air, water, or land different sites, the respondent need not from each site. report separately for each site but need (viii) A narrative description of the only notify EPA that the information times during the manufacturing, im- is the same for each site. The informa- porting, or processing operations in- tion to be reported under this para- volving P-TBBA, P-TBT, or P-TBB graph (d)(4) shall cover the respond- when environmental release occurs at ent’s latest complete corporate fiscal each site. year prior to June 25, 1986. Respondents (ix) A narrative description of any to this paragraph (d)(4) shall report the engineering controls used to prevent following information: environmental release of P-TBBA, P- (i) The total quantity (by weight) of TBT, or P-TBB at each site. P-TBBA, P-TBT, or P-TBB manufac- (x) A narrative description of all tured, imported, or processed for com- known end uses of any P-TBBA, P- mercial purposes per site. TBT, or P-TBB that is manufactured,

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imported, or processed by the respond- TBT, or P-TBB (per site) during the 2- ent. The narrative need not include year period, the anticipated routes of customer identity. worker exposure to the substances (xi) A narrative description of the (e.g., inhalation, ingestion, dermal ab- methods used at each site for disposing sorption); and a summary of any per- of wastes generated during the manu- sonal protective equipment and/or en- facture, importation, or processing of gineering controls that the respondent P-TBBA, P-TBT, or P-TBB, including intends to use to prevent exposure to the quantity and content of such the substances. wastes (per site), the method of dis- (iii) A narrative description of antici- posal, and an identification of the dis- pated environmental releases of P- posal site(s). TBBA, P-TBT, or P-TBB at each site (5) All manufactureres, importers, from the manufacture, importation, or and processors specified in paragraph processing of these substances during (b) of this section shall report the in- the first 2 years following the date on formation described in this paragraph which the respondent becomes subject (d)(5). Respondents to this paragraph to this rule. The narrative shall in- (d)(5) shall report separately for each clude the anticipated quantities of substance that they intend to manufac- each substance released directly into ture, import, or process during the first air, water, or land, the anticipated 2 years following the date on which routes of environmental release, and they become subject to this rule. The any intended engineering controls to data reported under this paragraph be used to prevent environmental re- (d)(5) shall cover that 2-year period. lease of the substances. Respondents to this paragraph (d)(5) (iv) A narrative description of all an- shall report separately for each site at ticipated end uses or P-TBBA, P-TBT, which they intend to manufacture, im- or P-TBB resulting from the respond- port, or process each substance. Re- ent’s manufacture, importation, or spondents need not comply with this processing of the substances during the paragraph (d)(5) if the information to first 2 years following the date on be reported is identical to that re- which the respondent becomes subject ported by the respondent under para- to this rule. The summary need not in- graph (d)(4) of this section, provided clude customer identity. that the respondent makes note of that (v) A narrative summary of the an- fact to EPA. Respondents to this para- ticipated disposal of wastes generated graph (d)(5) shall report the following from the manufacture, importation, or information: processing of P-TBBA, P-TBT, or P- (i) An estimate of the total quantity TBB during the first 2 years following (by weight) of P-TBBA, P-TBT, or P- the date on which the respondent be- TBB that the respondent intends to comes subject to this rule. The sum- manufacture, import, or process for mary shall include the anticipated commercial purposes per site during quantity and content of such wastes each of the first 2 years following the (per site), the intended method of dis- date on which the respondent becomes posal, and an identification of intended subject to this rule. disposal site(s). (ii) A narrative description of the in- (e) When to report. Persons subject to tended manufacturing, importing, or this rule must submit the requisite in- processing activities involving P- formation to EPA within 60 days of be- TBBA, P-TBT, or P-TBB at each site coming subject to the rule under the during the first 2 years following the standards set forth in paragraph (b) of date on which the respondent becomes this section. subject to this rule. The description (f) Certification. Persons subject to shall include a summary of the in- this rule must attach the following tended manufacturing, importing, or statement to any information sub- processing operation(s); a summary of mitted to EPA in response to this rule: intended worker activities involving ‘‘I hereby certify that, to the best of the substances, including an estimate my knowledge and belief, all of the at- of the number of persons anticipated to tached information is complete and ac- be exposed annually to P-TBBA, P- curate.’’ This statement shall be signed

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and dated by the company’s principal 45,400 kilograms (100,000 pounds) stand- technical contact. ard in paragraph (a)(5)(i) of this section (g) Recordkeeping. Persons subject to applies only to the amount of the the reporting requirements of this sec- chemical substance in a mixture and tion must retain documentation of in- not the other components of the mix- formation contained in their reports ture. for a period of 5 years from the date of (6) Waste means any solid liquid, the submission of the report. semisolid, or contained gaseous material that results from the production of [51 FR 17339, May 12, 1986; 51 FR 18323, May 19, 1986, as amended at 52 FR 20083, May 29, a chemical substance identified in 1987; 58 FR 34204, June 23, 1993] paragraph (b) of this section and which is to be disposed. § 704.43 Chlorinated naphthalenes. (b) Substances for which reports must (a) Definitions. (1) Extent of be submitted. chlorination means the percent by CAS registry number Chemical substance weight of chlorine. (2) Import means to import in bulk 90–13–1 ...... Naphthalene, 1-chloro- 91–58–7 ...... Naphthalene, 2-chloroform or as part of a mixture. 1321–64–8 ...... Naphthalene, pentachloro- (3) Isomeric ratio means the relative 1321–65–9 ...... Naphthalene, trichloro- amounts of each isomeric chlorinated 1335–87–1 ...... Naphthalene, hexachloro- 1335–88–2 ...... Naphthalene, tetrachloro- naphthalene that composes the chem- 1825–30–5 ...... Naphthalene, 1,5-dichloro- ical substance; and for each isomer the 1825–31–6 ...... Naphthalene, 1,4-dichloro- relative amounts of each chlorinated 2050–69–3 ...... Naphthalene, 1,2-dichloro- 2050–72–8 ...... Naphthalene, 1,6-dichloro- naphthalene designated by the position 2050–73–9 ...... Naphthalene, 1,7-dichloro- of the chlorine atom(s) on the naph- 2050–74–0 ...... Naphthalene, 1,8-dichloro- thalene. 2050–75–1 ...... Naphthalene, 2,3-dichloro- (4) Polychlorinated biphenyl means 2065–70–5 ...... Naphthalene, 2,6-dichloro- 2198–75–6 ...... Naphthalene, 1,3-dichloro- any chemical substance that is limited 2198–77–8 ...... Naphthalene, 2,7-dichloro- to the biphenyl molecule and that has 2234–13–1 ...... Naphthalene, octachloro- been chlorinated to varying degrees. 25586–43–0 ...... Naphthalene, chloro- 32241–08–0 ...... Naphthalene, heptachloro- (5) Small manufacturer means a manu- 70776–03–3 ...... Naphthalene, chloro derivatives. facturer (including importers) who meets either paragraph (a)(5) (i) or (ii) (c) Persons who must report. (1) Per- of this section: sons who are manufacturing or import- (i) A manufacturer of a chemical sub- ing a chemical substance identified in stance is small if its total annual sales, paragraph (b) of this section on Octo- when combined with those of its parent ber 8, 1984. company (if any), are less than $40 mil- (2) Persons who propose to import a lion. However, if the annual production chemical substance identified in para- volume of a particular chemical sub- graph (b) of this section on or after Oc- stance at any individual site owned or tober 8, 1984. controlled by the manufacturer is (3) Persons who manufacture a chem- greater than 45,400 kilograms (100,000 ical substance identified in paragraph pounds), the manufacturer shall not (b) of this section after October 8, 1984. qualify as small for purposes of report- (4) A person is required to report only ing on the production of that chemical once for each chemical substance iden- substance at that site, unless the man- tified in paragraph (b) of this section. ufacturer qualifies as small under para- (d) Persons exempt from reporting. (1) graph (a)(5)(ii) of this section. Small manufacturers. (ii) A manufacturer of a chemical (2) Persons described in § 704.5. substance is small if its total annual (e) What information to report. Persons sales, when combined with those of its described in paragraph (c) of this sec- parent company (if any), are less than tion must notify EPA of current or $4 million, regardless of the quantity of prospective manufacture or import. the particular chemical substance pro- The notice must include, to the extent duced by that manufacturer. that it is known to or reasonably as- (iii) For imported mixtures con- certainable by the person making the taining a chemical substance identified report, the following information: in paragraph (b) of this section, the (1) Company name and address.

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(2) Name, address, and telephone must notify EPA within 30 days after number of the principal technical con- the initial date of manufacture. tact. [49 FR 33653, Aug. 24, 1984; 49 FR 45133, Nov. (3) For chemical substances proposed 15, 1984; 50 FR 1215, Jan. 10, 1985; 51 FR 19839, to be imported, the proposed date of June 3, 1986; 52 FR 20083, May 29, 1987. Redes- import. ignated at 53 FR 51717, Dec. 22, 1988] (4) A description of the use(s) or intended use(s) for the chemical sub- § 704.45 Chlorinated terphenyl. stance. (a) Definitions. (1) Chlorinated (5) A description of the isomeric ratio terphenyl means a chemical substance, and extent of chlorination of the chem- CAS No. 61788–33–6, comprised of ical substance and the impurity level chlorinated ortho-, meta-, and of polychlorinated biphenyls. paraterphenyl. (6) The quantity (by weight) manu- (2) Extent of chlorination means the factured or imported within 12 months percent by weight of chlorine for each prior to October 8, 1984, if any, and the isomer (ortho, meta, and para). estimated quantity (by weight) to be (3) Isomeric ratio means the ratios of manufactured or imported for the first ortho-, meta-, and parachlorinated 3 years following the date of the report terphenyls. or the date of the intended start of im- (4) Polychlorinated biphenyl means port whichever occurs later. any chemical substance that is limited (7) The number of persons exposed to to the biphenyl molecule that has been the chemical substance during manu- chlorinated to varying degrees. facture, import, processing, distribu- (5) Small manufacturer means a manu- tion in commerce, use, and disposal. facturer (importers are defined as man- (8) If a manufacturer’s waste con- ufacturers under TSCA) who meets ei- tains one or more of the chemical sub- ther of the following standards under stances identified in paragraph (b) of this rule: this section, the manufacturer must: (i) First standard. A manufacturer of (i) Provide the quantity (by weight) an existing chemical substance is small of the chemical substances identified if its total annual sales, when com- in paragraph (b) of this section present bined with those of its parent company in the waste. (if any), are less than $40 million. How- (ii) Identify the constituents of the ever, if the annual production volume waste and their concentrations, of a particular chemical substance at (iii) State the rate of waste genera- any individual site owned or controlled tion as a percentage of production vol- by the manufacturer is greater than ume, 45,400 kilograms (100,000 pounds), the (iv) Describe where in the manufac- manufacturer shall not qualify as turing process the waste is generated, small for purposes of reporting on the and production of that chemical substance (v) Describe the method for disposal at the site, unless the manufacturer of the waste. qualified as small under paragraph (f) When to report. (1) Persons who are (a)(5)(ii) of this section. manufacturing or importing a chem- (ii) Second standard. A manufacturer ical substance identified in paragraph of an existing chemical substance is (b) of this section on October 8, 1984 small if its total annual sales, when must notify EPA by November 6, 1984. combined with those of its parent com- (2) Persons who propose to import a pany (if any), are less than $4 million, chemical substance identified in para- regardless of the quantity of chemicals graph (b) of this section on or after Oc- produced by that manufacturer. tober 8, 1984 must notify EPA by No- (b) Persons who must report. Except vember 6, 1984, or 15 days after making for small manufacturers and as pro- the management decision described in vided in § 704.5, the following persons § 704.3, whichever is later in time. are subject to the rule: (3) Persons who manufacture a chem- (1) Persons who manufacture or pro- ical substance identified in paragraph pose to manufacture chlorinated (b) of this section after October 8, 1984 terphenyl.

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(2) Persons who import (importers) or which reporting is required under this propose to import chlorinated section are: terphenyl as a chemical substance in bulk or as part of a mixture. CAS No. Chemical name (c) What information to report. Persons 1429–50–1 Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis subject to this rule as described in (methylene)]] tetrakis- (EDTMPA) 15142–96–8 Phosphonic acid, [1,2-ethanediyl- paragraph (b) of this section must no- bis[nitrilobis(methylene)]] tetrakis-, tify EPA of current or proposed manu- hexasodium salt facture or import of chlorinated 34274–30–1 Phosphonic acid, [1,2-ethanediyl- terphenyl. The notice must include, to bis[nitrilobis(methylene)]] tetrakis-, potassium salt the extent that it is known to the per- 57011–27–5 Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis son making the report or is reasonably (methylene)]] tetrakis-, ammonium salt ascertainable, the following informa- 67924–23–6 Cobaltate (6-), [[[1,2-ethanediylbis [nitrilobis (methylene)]] tetrakis-[phosphonato]] (8-)]-, tion: pentapotassium hydrogen, (OC–6–21)- (1) Company name and address. 67969–67–9 Cobaltate (6-), [[[1,2-ethanediylbis [nitrilobis (2) Name, address, and telephone (methylene)]] tetrakis- [phosphonato]] (8-)- N,N′,O,O″,O″″,O″″″]-, pentasodium hydro- number of principal technical contact. gen, (OC–6–21)- (3) A description of the use(s) or in- 67989–89–3 Cuprate (6-), [[[1,2-ethanediylbis [nitrilobis tended use(s) for chlorinated terphenyl. (methylene)]] tetrakis- [phosphonato]] (8-)]-, pentapotassium hydrogen, (OC–6–21)- (4) A description of the isomeric ratio 68025–39–8 Cobaltate (6-), [[[1,2-ethanediylbis [nitrilobis and extent of chlorination of the (methylene)]] tetrakis- [phosphonato]] (6-)- chlorinated terphenyl and the impurity N,N′,O,O″,O″″,O″″″]-, pentaammonium hy- level of polychlorinated biphenyls. drogen, (OC–6–21)- 68188–96–5 Phosphonic acid, [1,2-ethanediylbis [nitrilobis (5) The quantity (by weight) manu- (methylene)]] tetrakis-, tetrapotassium salt factured or imported within 12 months 68309–98–8 Cadmate (6-), [[[1,2-ethanediylbis [nitrilobis prior to the effective date of the rule, if (methylene)]] tetrakis- [phosphonato]] (8-)]-, pentapotassium hydrogen, (OC–6–21)- any, and the estimated quantity (by 68901–17–7 Phosphonic acid, [1,2-ethanediylbis [nitrilobis weight) to be manufactured or im- (methylene)]] tetrakis-, octaammonium salt ported for the first three years fol- 68958–86–1 Nickelate (6-), [[[1,2-ethanediylbis [nitrilobis (methylene)]] tetrakis- [phosphonato]] (8-)]-, lowing the date of the report or the pentaammonium hydrogen, (OC–6–21)- date of the intended start of produc- 68958–87–2 Nickelate (6-), [[[1,2-ethanediylbis [nitrilobis tion, whichever occurs later. (methylene)]] tetrakis- [phosphonato]] (8-)]-, (6) The proposed date for the initi- pentapotassium hydrogen, (OC–6–21)- 68958–88–3 Nickelate (6-), [[[1,2-ethanediylbis [nitrilobis ation of manufacturing or importation (methylene)]] tetrakis [phosphonato]] (8-)]-, of chlorinated terphenyl, if appro- pentasodium hydrogen, (OC–6–21)- priate. (d) When to report. Persons who are (b) Persons who must report. Unless ex- manufacturing or importing empt as provided in § 704.5, reports chlorinated terphenyl on the effective must be submitted by: date of the rule must notify EPA with- (1) Persons who manufacture or im- in 30 days of the effective date of the port any of the substances identified in rule. Persons who propose to manufac- paragraph (a) of this section. ture or import chlorinated terphenyl (2) Persons who propose to manufac- must notify EPA within 15 days after ture or propose to import any of the making the management decision de- substances identified in paragraph (a) scribed in § 704.3 ‘‘Proposed to manufac- of this section. For the purposes of im- ture or import’’. porter reporting under this section, an import site is the operating unit within [49 FR 11184, Mar. 26, 1984, as amended at 49 the person’s organization which is di- FR 32068, Aug. 10, 1984; 50 FR 2048, Jan. 15, rectly responsible for importing the 1985; 52 FR 20083, May 29, 1987. Redesignated at 53 FR 51717, Dec. 22, 1988; 58 FR 34204, June substance and which controls the im- 23, 1993] port transaction; the import site may in some cases be the organization’s § 704.95 Phosphonic acid, [1,2- headquarters office in the United ethanediyl-bis[nitrilobis-(meth- States. ylene)]]tetrakis- (EDTMPA) and its (c) What information to report. Persons salts. identified in paragraph (b) of this sec- (a) Substances for which reporting is re- tion must report to EPA, for each of quired. The chemical substances for the substances identified in paragraph

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(a) of this section, the following infor- (2) Persons specified in paragraph mation to the extent known to or rea- (b)(2) of this section must submit an sonably ascertainable by them. initial report within 30 days after mak- (1) Initial Report: ing the management decision described (i) Name and Chemical Abstracts in § 704.3 or by January 3, 1989, which- Service Registry Number of the sub- ever is later. stance for which the report is sub- (3) Persons specified in paragraph (b) mitted. of this section, who submitted a report (ii) Company name and headquarters described in paragraph (c)(1) of this address. section, must submit a follow-up report (iii) Name, address, and telephone described in paragraph (c)(2) of this number of the principal technical con- section within 30 days of making the tact. management decision, described at (iv) The total quantity (by weight in § 704.3, to do either of the following pounds) of the substance manufactured events: or imported for the person’s most re- (i) Manufacture or import the sub- cently completed corporate fiscal year. stance in a quantity 50 percent greater (v) A description of the commercial than the quantity reported in the most uses of the substance during the per- recently submitted report. son’s most recently completed cor- (ii) Manufacture or import the sub- porate fiscal year, including the pro- stance for a use not reported for that duction volume for each use. substance in any previous report. (vi) The estimated quantity (by (e) Certification. Persons subject to weight in pounds) of the substance pro- this section must attach the following posed to be manufactured or imported statement to any information sub- in the person’s current corporate fiscal mitted to EPA in response to this sec- year. tion: ‘‘I hereby certify that, to the best (vii) A description of the intended of my knowledge and belief, all of the commercial uses of the substance dur- attached information is complete and ing the person’s current corporate fis- accurate.’’ This statement must be cal year, including the estimated pro- signed and dated by the company’s duction volume for each use. principal technical contact. (2) Follow-up Report: (f) Recordkeeping. Persons subject to (i) Name and Chemical Abstracts the reporting requirements of this sec- Service Registry Number of the sub- tion must retain documentation of instance for which the report is sub- formation contained in their reports mitted. for a period of 5 years from the date of (ii) Company name and headquarters the submission of the report. address. [53 FR 41337, Oct. 21, 1988, as amended at 58 (iii) Name, address, and telephone FR 34204, June 23, 1993] number of the principal technical contact. § 704.102 Hexachloronorbornadiene. (iv) The estimated quantity (by (a) Definitions. (1) Endrin means the weight in pounds) of the substance pro- pesticide 2,7:3,6-Dimethanonaphth[2,3- posed to be manufactured or imported b]oxirene,3,4,5,6,9,9-hexachloro- in the person’s current corporate fiscal 1a,2,2a,3,6,6a,7,7a-octahydro-, (1aalpha, year. 2beta, 2abeta, 3alpha, 6alpha, 6abeta, (v) A description of the intended 7beta, 7aalpha)-, CAS Number 72–20–8. commercial uses of the substance dur- (2) HEX-BCH means the chemical ing the person’s current corporate fis- substance 1,2,3,4,7,7- cal year, including the estimated pro- hexachloronorbornadiene, CAS Number duction volume for each use. 3389–71–7. (d) When to report. (1) Persons speci- (3) Isodrin means the pesticide 1,4:5,8- fied in paragraph (b)(1) of this section Dimethanonaphthalene,1,2,3,4,10,10- who are manufacturing or importing hexacholoro-1,4,4a,5,8,8a-hexahydro-, the substance as of December 5, 1988 (1alpha, 4alpha, 4abeta, 5beta, 8beta, must submit an initial report described 8abeta)-, CAS Number 465–73–6. in paragraph (c)(1) of this section by (4) Small business means any manufac- January 3, 1989. turer, importer, or processor who

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meets either paragraph (a)(4)(i) or (ii) (2) Persons described in paragraph of this section: (b)(1) of this section who engage or pro- (i) A business is small if its total an- pose to engage in more than one activ- nual sales, when combined with those ity (i.e., manufacture and processing) of its parent (if any), are less than $40 must report the information required million. However, if the annual manu- in paragraph (d) separately for each ac- facture, importation, or processing vol- tivity. ume of a particular chemical substance (c) Persons exempt from reporting. (1) at any individual site owned or con- Small businesses. trolled by the business is greater than (2) Persons described in § 704.5(a) and 45,400 kilograms (100,000 pounds), the (c). business shall not qualify as small for (d) Information to report. (1) Initial re- purposes of reporting on the manufac- ports must include, to the extent that ture, importation, or processing of that it is known to or reasonably ascertain- chemical substance at that site, unless able by the person reporting, the fol- the business qualifies as small under lowing information: paragraph (a)(4)(ii) of this section. (i) Company name and address. (ii) A business is small if its total an- (ii) Name, address, and telephone nual sales, when combined with those number of the principal contact. of its parent company (if any), are less (iii) Name and address of plant sites than $4 million, regardless of the quan- where HEX-BCH is or is proposed to be tity of the particular chemical sub- manufactured, imported, or processed, stance manufactured, imported, or noting for each plant site which activ- processed by that business. ity takes or would take place at each (iii) For imported and processed mix- site. tures containing HEX-BCH, the 45,400 (iv) If applicable, the intended date kilograms (100,000 pounds) standard in for initiating the manufacture, import, paragraph (a)(4)(i) of this section ap- or processing of HEX-BCH. plies only to the amount of HEX-BCH (v) If applicable, the actual quantity in a mixture and not the other compo- (by weight) of HEX-BCH manufactured, nents of the mixture. imported, or processed during the most (5) 8-hour time weighted average means recently concluded year. the cumulative exposure for an 8-hour (vi) The estimated quantity (by work shift computed as follows: weight) of HEX-BCH to be manufactured, imported, or processed each year during the first 3 years following the date of the report or the date of the intended start of manufacture, import, or Where: processing, whichever occurs later. E is the equivalent exposure for the working (vii) For each year described in para- shift. graphs (d)(1) (v) and (vi) of this section: Ci is the concentration (i.e., parts per mil- the number or expected number of em- lion) during any period of time (Ti) where ployees exposed to HEX-BCH during the concentration remains constant. the manufacture, import, processing, Ti is the duration in hours of the exposure at distribution in commerce, use, and dis- the concentration Ci. posal; the routes of exposure; and the 8- (6) Year means corporate fiscal year. hour time weighted average of expo- (b) Persons who must report. (1) Re- sure. ports must be submitted by: (viii) If employees are exposed or ex- (i) Persons who are manufacturing, pected to be exposed to HEX-BCH, importing, or processing HEX-BCH for state for each reported route of expo- use as an intermediate in the produc- sure, whether personal protective tion or isodrin or endrin on or after equipment is used or expected to be January 2, 1986; and used, and a description of the personal (ii) Persons who propose to manufac- protective equipment. ture, import, or process HEX-BCH for (ix) The actual or anticipated quan- use as an intermediate in the produc- tity, content, method of disposal, and tion of isodrin or endrin, on or after disposal site of any wastes generated or January 2, 1986. expected to be generated during the

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manufacture, importation, or proc- (vii) Three years have passed since essing of HEX-BCH. the most recent submission of a report (2) Subsequent reports must provide, and the person is still engaged in the to the extent known to or reasonably manufacture, importation, or proc- ascertainable by the person reporting, essing of HEX-BCH. the information in paragraph (d)(1) of (f) Certification of review. Each person this section and a statement explaining who submits a report under this sec- why the subsequent report is required. tion must for 3 years following the sub- (e) When to report. (1) Persons who are mission date of the most recent sub- manufacturing, importing, or proc- mission, review their activities at the essing HEX-BCH on January 2, 1986, end of each year to determine whether must submit an initial report to EPA any reportable event specified in para- by February 3, 1986. graph (e)(3) of this section has oc- (2) Persons who propose to manufac- curred. If a review shows that none of ture, import, or process HEX-BCH on these events has occurred, the person is or after January 2, 1986, must submit required to certify this fact in writing. an initial report to EPA by February 3, (g) Recordkeeping. Any person subject 1986, or 30 days after making the man- to the reporting requirements of this agement decision described in § 704.3 section must: ‘‘Propose to manufacture, import, or (1) Retain documentation of informa- process,’’ whichever is later in time. tion contained in their reports. This (3) Persons described in paragraph (b) documentation must be maintained for of this section, who have submitted a a period of 3 years from the date of the report described in paragraph (d) of submission of the report; and this section, must submit a subsequent (2) Retain the certification required report within 30 days of any of the fol- by paragraph (f) of this section for 3 lowing events. Based on the most re- years from the date of its creation. cently submitted report: (i) The manufacture, importation, or [50 FR 47536, Nov. 19, 1985, as amended at 52 processing of HEX-BCH begins at a FR 20083, May 29, 1987. Redesignated at 53 FR plant site different than that reported 51717, Dec. 22, 1988; 58 FR 34204, June 23, 1993] pursuant to paragraph (d)(1)(iii) of this section. § 704.104 Hexafluoropropylene oxide. (ii) The actual quantity (by weight) (a) Definitions. (1) ‘‘HFPO’’ means the of HEX-BCH manufactured, imported, chemical substance or processed in a given year is greater hexafluoropropylene oxide, CAS Num- than or equal to 200 percent of the esti- ber 428–59–1. [Listed in TSCA Inventory mated value for that year reported pur- as oxirane, trifluoro(trifluoromethyl)-] suant to paragraph (d)(1)(vi) of this sec- (2) ‘‘Enclosed process’’ means a proc- tion. ess that is designed and operated so (iii) The total number of employees that there is no intentional release of exposed to HEX-BCH is greater than any substance present in the process. A 130 percent of the projected value re- process with fugitive, inadvertent, or ported pursuant to paragraph (d)(1)(vii) emergency pressure relief releases re- of this section. mains an enclosed process so long as (iv) The route of exposures to HEX- measures are taken to prevent worker BCH differs from that reported pursu- exposure to and environmental con- ant to paragraph (d)(1)(vii) of this sec- tamination from the releases. tion. (3) ‘‘Small processor’’ means a proc- (v) The actual 8-hour time weighted essor that meets either the standard in average exposure for any activity ex- paragraph (a)(3)(i) of this section or the ceeds the projection reported pursuant standard in paragraph (a)(3)(ii) of this to paragraph (d)(1)(vii) of this section section. by more than 100 percent. (i) First standard. A processor of a (vi) The method of disposal or dis- chemical substance is small if its total posal site reported pursuant to para- annual sales, when combined with graph (d)(1)(ix) of this section has those of its parent company, if any, are changed. less than $40 million. However, if the

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annual processing volume of a par- (d) What information to report. Persons ticular chemical substance at any indi- identified in paragraph (b) of this sec- vidual site owned or controlled by the tion must submit a Premanufacture processor is greater than 45,400 kilo- Notice Form (EPA Form 7710–25). grams (100,000 pounds), the processor (e) When to report. (1) Persons who are shall not qualify as small for purposes manufacturing, importing, or proc- of reporting on the processing of that essing, or who propose to manufacture, chemical substance at that site, unless import, or process HFPO for use as an the processor qualifies as small under intermediate in the manufacture of paragraph (a)(3)(ii) of this section. fluorinated substances in an enclosed (ii) Second standard. A processor of a process as of December 10, 1987, must chemical substance is small if its total report by February 8, 1988. annual sales, when combined with (2) Persons who propose to manufac- those of its parent company (if any), ture, import, or process HFPO for use are less than $4 million, regardless of as an intermediate in the manufacture the quantity of the particular chemical of fluorinated substances in an en- substance processed by that company. closed process after December 10, 1987, (iii) Inflation index. EPA will use the must report within 30 days after mak- Inflation Index described in the defini- ing a firm management decision to tion of ‘‘small manufacturer’’ that is commit financial resources for the set forth in § 704.3 for purposes of ad- manufacturing, importing, or proc- justing the total annual sales values of essing of HFPO. this small processor definition. EPA (f) Recordkeeping. Persons subject to will provide FEDERAL REGISTER notifi- the reporting requirements of this sec- cation when changing the total annual tion must retain documentation of in- sales values of this definition. formation contained in their reports (b) Persons who must report. Except as for a period of 5 years from the date of provided in paragraph (c) of this sec- submission of the reports. tion, the following persons are subject to this section: (g) Where to send reports. Reports must be submitted by certified mail to (1) Persons who manufacture or pro- the Document Control Office (DCO) pose to manufacture HFPO for use as (7407M), Office of Pollution Prevention an intermediate in the manufacture of fluorinated substances in an enclosed and Toxics (OPPT), Environmental process. Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001, (2) Persons who import or propose to ATTN: HFPO Reporting. import HFPO for use as an intermediate in the manufacture of [52 FR 41299, Oct. 27, 1987, as amended at 58 fluorinated substances in an enclosed FR 34204, June 23, 1993; 60 FR 16308, Mar. 29, process. 1995; 60 FR 31920, June 19, 1995; 60 FR 34463, (3) Persons who process or propose to July 3, 1995; 71 FR 33641, June 12, 2006] process HFPO as an intermediate in ′ the manufacture of fluorinated sub- § 704.175 4,4 -methylenebis(2- stances in an enclosed process. chloroaniline) (MBOCA). (c) Persons not subject to this rule. The (a) Substance subject to reporting. The following persons are not subject to chemical substance 4,4′-methylenebis(2- this rule: chloroaniline) (CAS No. 101–14–4) is (1) Small processors. subject to reporting under this section. (2) Persons described in § 704.5 (a) The substance also is identified as 4,4′- through (d). methylenebis(2-chlorobenzenamine) (3) Persons who have already sub- and MBOCA. mitted to EPA a completed copy of the (b) Persons who must report. Except as Preliminary Assessment Information provided in paragraph (c) of this sec- Manufacturer’s Report (EPA Form tion, the following persons are subject 7710–35, as described at § 712.28 of this to this rule. chapter) for HFPO are not required to (1) Persons who propose to manufac- report under this section with respect ture MBOCA in the United States on or to activities previously reported on. after June 2, 1986.

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(2) Persons who are manufacturing (2) Persons specified in paragraph MBOCA in the United States as of June (b)(2) of this section must report by 2, 1986. July 2, 1986. (3) Persons manufacturing MBOCA in (3) Persons specified in paragraph the United States on or after June 2, (b)(3) of this section must report within 1986 who propose to change their man- 30 days of making a firm management ner or method of manufacturing the decision to commit financial resources substance from a manner or method of to change their manner or method of manufacturing that previously was re- manufacturing the substance from a ported under this section. manner or method of manufacturing (c) Persons not subject to this rule. The that previously was reported under this following persons are exempt from the section. reporting requirements of this section: [51 FR 13223, Apr. 18, 1986, as amended at 52 (1) Persons who import MBOCA into FR 20083, May 29, 1987; 58 FR 34204, June 23, the customs territory of the United 1993] States and do not otherwise manufacture the substance in the United PART 707—CHEMICAL IMPORTS States. AND EXPORTS (2) Persons who complied with the requirements of this section prior to Subpart A [Reserved] June 2, 1986 and received written notification of compliance from EPA. Subpart B—General Import Requirements (d) What information to report. Persons and Restrictions who are subject to this rule as described in paragraph (b) of this section Sec. must report information to EPA by 707.20 Chemical substances import policy. completing the following parts of the notice form contained in appendix A to Subpart C [Reserved] part 720 of this chapter: Parts I.A., I.B., Subpart D—Notices of Export Under I.C.1., I.C.3., and II.A.; also, part III as Section 12(b) appropriate. Persons subject to the requirements of this section also must 707.60 Applicability and compliance. submit a narrative description of any 707.63 Definitions. processing and packaging of MBOCA 707.65 Submission to agency. that occurs at the manufacturing plant 707.67 Contents of notice. site, including the number of workers 707.70 EPA notice to foreign governments. potentially exposed to MBOCA during 707.72 Termination of reporting require- on-site processing and packaging of ments. MBOCA and a description of any per- 707.75 Confidentiality. sonal protective equipment and/or en- AUTHORITY: 15 U.S.C. 2611(b) and 2612. gineering controls that would be used SOURCE: 45 FR 82850, Dec. 16, 1980, unless to prevent release of and exposure to otherwise noted. MBOCA during on-site processing and packaging. Persons subject to the requirements of this section are not re- Subpart A [Reserved] quired to submit information on processing or use of MBOCA away from the Subpart B—General Import manufacturing plant site. Respondents Requirements and Restrictions to this rule shall report all information that is known to or reasonably ascer- § 707.20 Chemical substances import tainable by the person reporting. policy. (e) When to report. (1) Persons speci- (a) Scope. (1) This statement address- fied in paragraph (b)(1) of this section es the policy of the Environmental must report by July 2, 1986 or within 30 Protection Agency (EPA) on importa- days after making a firm management tion of chemical substances, mixtures, decision to commit financial resources and articles under section 13 of the for the manufacture of MBOCA, which- Toxic Substances Control Act (TSCA; ever is later in time. 15 U.S.C. 2601 et seq.). In particular, it

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addresses aspects of the regulation pro- in violation of TSCA or any applicable mulgated by the United States Cus- rule or order under TSCA.’’ The certifi- toms Service (Customs), Department of cation will document that, in accord- the Treasury (19 CFR 12.118 through ance with TSCA, the importer has 12.127, and 127.28 [amended]) to imple- taken the necessary steps to insure ment section 13 of TSCA, 15 U.S.C. 2612. compliance. Section 13 requires the Secretary of the (ii) The section 13 rule requires im- Treasury to refuse entry into the Cus- porters of chemicals not subject to toms territory of the United States of TSCA (e.g., pesticides) to certify that a chemical substance, mixture, or arti- compliance with TSCA is not required. cle if it does not comply with rules in Importers must certify this by signing effect under TSCA, or if it is offered for the statement: ‘‘I certify that all entry in violation of TSCA or rules or chemicals in this shipment are not sub- orders under TSCA. ject to TSCA.’’ This is appropriate (2) In addition to this statement of when a chemical import is not clearly policy, EPA will continue, as nec- identified as a pesticide or other chem- essary, to address problems associated ical not subject to TSCA. with imports in rulemaking and other (3) The United States is involved in a actions under individual sections of major effort toward international har- TSCA, i.e., sections 4, 5, 6, 7, 8, and 12. monization in the control of chemicals. Sections 5, 6, and 7 apply directly to At such time as international agree- imports subject to the section 13 re- ment is reached on this issue, EPA quirements. Section 12 may apply to would be prepared to modify its policy export of a shipment that is refused if necessary. EPA believes that its entry under section 13. Importers may international harmonization efforts in have obligations under sections 4 and 8; the control of chemicals will protect section 4 and 8 requirements for im- health and the environment while ful- porters would not apply to individual filling its obligations under the Trade chemical shipments and thus are not Agreements Act of 1979. included under section 13 requirements. (c) The section 13 rule—(1) General cer- Interested persons should refer to the tification. (i) The rule promulgated records of these individual rulemaking under section 13 of TSCA by Customs, actions for specific information and in consultation with EPA, implements guidance. the requirement of section 13 that (b) Objectives. (1) TSCA is intended to chemical substances, mixtures, or arti- be comprehensive, and assure protec- cles not in compliance with TSCA, or tion of health and the environment whose importation is not in compliance from unreasonable risks associated with TSCA, shall be denied entry into with chemicals whether the chemicals the customs territory of the United are imported or produced domestically. States. The rule requires that import- This intent is manifested by the inclu- ers certify by a statement, on the sion of importation in the Act’s defini- entry document or invoice, that any tion of the term ‘‘manufacture’’: shipment of a chemical substance sub- ‘‘[M]anufacture means to import * * *, ject to TSCA, imported in bulk or as produce, or manufacture’’ (15 U.S.C. part of a mixture, complies with TSCA, 2602(7)). Thus, importers are respon- and that it is not offered for entry in sible for insuring that chemical impor- violation of TSCA or any rule or order tation complies with TSCA just as do- under TSCA, or that the chemicals im- mestic manufacturers are responsible ported are not subject to TSCA. for insuring that chemical manufac- (ii) The certification applies to TSCA ture complies with TSCA. sections 5, 6, and 7. (2)(i) The section 13 rule requires im- (iii) EPA expects that this certifi- porters to sign the following statement cation will be based upon actual knowl- for each import of chemical substances edge of the importer in most cases. subject to TSCA: ‘‘I certify that all However, EPA realizes that sometimes chemical substances in this shipment importers may not have actual knowl- comply with all applicable rules or or- edge of the chemical composition of ders under TSCA and that I am not of- imported mixtures. In these cases, the fering a chemical substance for entry importer should attempt to discover

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the chemical constituents of the ship- REGION III ment by contacting another party to Curtis Building, 6th and Walnut Streets, the transaction (e.g., his principal or Philadelphia, PA 19106 (215–597–7668) the foreign manufacturer). This person may be able to identify the components REGION IV of the mixture, or at least state that 345 Courtland Street, NE., Atlanta, GA 30365 the substances comply with TSCA. The (404–881–3864) greater the effort an importer makes to learn the identities of the imported REGION V substances and their compliance with 77 West Jackson Boulevard, Chicago, IL 60604 TSCA, the smaller his chance of com- (312–353–2291)

mitting a violation by importing a REGION VI noncomplying shipment. If a shipment is ultimately determined to have vio- 1201 Elm Street, Dallas, TX 75270 (214–767– lated TSCA, the good faith efforts of 2734) the importer to verify compliance, as REGION VII evidenced by documents contained in his files, may obviate or mitigate the 324 East 11th Street, Kansas City, MO 64106 (816–374–3036) assessment of a civil penalty under section 16 of TSCA. REGION VIII (2) EPA enforcement. (i) EPA and Cus- 1860 Lincoln Street, Denver, CO 80295 (303– toms will monitor chemical imports to 837–3926) determine if shipments and their import comply with the certification re- REGION IX quirements and the substantive man- 75 Hawthorne Street, San Francisco, CA dates of TSCA. Customs will refuse 94105 (415) 947–4402. entry to any shipment until such time as the certification is properly sub- REGION X mitted. Customs will also detain a 1200 Sixth Avenue, Seattle, WA 98101 (206– shipment if there are reasonable 442–2871) grounds to believe that such shipment (iii) If Customs detains or refuses or its import violates TSCA or regula- entry of a shipment (other than for tions or orders thereunder. A violative failure to make the general certifi- shipment must either be brought into cation) and the importer takes meas- compliance, exported, destroyed, or ures necessary to bring the shipment voluntarily abandoned within the time into conformity with the requirements periods prescribed in 19 CFR 12.124 of of TSCA, EPA officials will reassess the section 13 rule. the shipment to determine its current (ii) When EPA determines that a compliance status. When a shipment is shipment should be detained, EPA will no longer in violation, EPA will notify identify the reasons for the detention the district director and the importer. and the necessary actions for an im- The district director will then release porter to bring the shipment into com- the shipment. This notice will also pliance with TSCA. If EPA has given serve as a determination to permit this information to Customs before the entry under 19 CFR 12.123(c) if a ship- district director issues the detention ment is brought into compliance before notice, the information will become the 19 CFR 12.123(c) decisionmaking part of the detention notice. The im- process has been completed. If compli- porter should contact one of the fol- ance is achieved after a 19 CFR 12.123(c) lowing EPA regional offices for guid- determination (adverse to the im- ance as to the proper procedures to cor- porter) has been made, the EPA notice rect any deficiencies in the shipment. to the district director will serve as a REGION I reversal of the decision to refuse entry. John F. Kennedy Federal Building, Boston, (3) EPA assistance. Assistance in de- MA 02203 (617–223–0586) termining whether a chemical shipment is in compliance with TSCA can REGION II be obtained from the Director, Envi- 26 Federal Plaza, New York, NY 10278 (201– ronmental Assistance Division (7408), 321–6669) Office of Pollution Prevention and

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Toxics, U.S. Environmental Protection (i) A chemical substance or mixture Agency, Room E–543B, 1200 Pennsyl- listed as a ‘‘known to be human car- vania Ave., NW., Washington, DC 20460, cinogen’’ or ‘‘reasonably anticipated to Telephone: (202) 554–1404, TDD: (202) be human carcinogen’’ in the Report on 544–0551. Carcinogens (latest edition) issued by [48 FR 55464, Dec. 13, 1983, as amended at 60 the U.S. Department of Health and FR 34463, July 3, 1995; 62 FR 1834, Jan. 14, Human Services, Public Heath Service, 1997; 75 FR 69353, Nov. 12, 2010] National Toxicology Program, (ii) A chemical substance or mixture Subpart C [Reserved] is classified as ‘‘carcinogenic to humans’’ (Group 1), ‘‘probably carcinogenic to humans’’ (Group 2A), or Subpart D—Notices of Export ‘‘probably carcinogenic to humans’’ Under Section 12(b) (Group 2B) in the Monographs and Sup- § 707.60 Applicability and compliance. plements on the Evaluation of Carcino- genic Risks to Humans issued by the (a) Section 12(b) of the Toxic Sub- World Health Organization Inter- stances Control Act requires any per- national Agency for Research on Can- son who exports or intends to export a cer (IARC), Lyons, France (latest edi- chemical substance or mixture to no- tions), or tify the Environmental Protection (iii) Alpha-naphthylamine (Chemical Agency of such exportation to a par- Abstract Service Registry Number ticular country if any of the following (CAS No.) 134–32–7) or 4–nitrobiphenyl actions have been taken under the Act (CAS No. 92–93–3). with respect to that chemical sub- (3) No notice of export is required for stance or mixture: the export of polychlorinated biphenyl (1) Data are required under section 4 chemicals (PCBs) (see definition in 40 or 5(b), CFR 761.3), where such chemical sub- (2) An order has been issued under stances are present in a concentration section 5, of less than or equal to 50 ppm (by (3) A rule has been proposed or pro- weight or volume). mulgated under section 5 or 6, or (d) Any person who exports or in- (4) An action is pending, or relief has tends to export PCBs or PCB articles been granted under section 5 or 7. (see definition in 40 CFR 761.3), for any (b) No notice of export will be re- purpose other than disposal, shall no- quired for articles, except PCB articles, tify EPA of such intent or exportation unless the Agency so requires in the under TSCA section 12(b), except as context of individual section 5, 6, or 7 specified in § 707.60(c)(3). PCBs and PCB actions. articles have the definitions published (c)(1) Except as provided in para- in 40 CFR 761.3. graphs (c)(2) and (3) of this section no notice of export is required for the ex- (e) Any person who would be prohib- port of a chemical substance or mix- ited by a TSCA section 5 or 6 regula- ture for which export notification is tion from exporting a chemical sub- otherwise required, where such chem- stance or mixture, but who is granted ical substance or mixture is present in an exemption by EPA to export that a concentration of less than 1% (by chemical substance or mixture, shall weight or volume). notify EPA under TSCA section 12(b) of (2) No notice of export is required for such intent to export or exportation. the export of a chemical substance or (f) Failure to comply with TSCA sec- mixture that is a known or potential tion 12(b) as set forth in this part will human carcinogen where such chemical be considered a violation of TSCA sec- substance or mixture is present in a tion 15(3), and will subject the exporter concentration of less than 0.1% (by to the penalty, enforcement, and sei- weight or volume). A chemical is con- zure provisions of TSCA sections 16 and sidered to be a known or potential 17. human carcinogen, for purposes of [45 FR 82850, Dec. 16, 1980, as amended at 71 TSCA section 12(b) export notification, FR 66244, Nov. 14, 2006; 71 FR 68751, Nov. 28, if that chemical is: 2006]

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§ 707.63 Definitions. EPA a notice of export to that country prior to January 16, 2007. The definitions set forth in the Toxic (3) The notice must be postmarked Substances Control Act, section 3, within seven days of forming the intent apply for this part. In addition, the fol- to export or on the date of export, lowing abbreviations and definitions whichever is earlier. A notice of intent are provided for purposes of this rule: to export must be based on a definite (a) EPA means the Environmental contractual obligation, or an equiva- Protection Agency. lent intra-company agreement, to ex- (b) Exporter means the person who, as port the regulated chemical. the principal party in interest in the (b) If the EPA action that prompts export transaction, has the power and the notice is a proposed rule, the re- responsibility for determining and con- quirement to submit export notices to trolling the sending of the chemical EPA shall begin thirty days after pub- substance or mixture to a destination lication of the action in the FEDERAL out of the customs territory of the REGISTER. United States. (c) Notices shall be marked ‘‘TSCA (c) Regulated chemical means any Section 12(b) Notice’’ and sent to EPA chemical substance or mixture for by mail or delivered by hand or cou- which export notice is required under rier. Send notices by mail to: Docu- § 707.60. ment Control Office (7407M), Office of (d) TSCA means the Toxic Substances Pollution Prevention and Toxics Control Act. (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., § 707.65 Submission to agency. Washington, DC 20460–0001 (Attention: (a) For each action under TSCA trig- TSCA Section 12(b) Notice). Hand de- gering export notification, exporters livery of TSCA section 12(b) notices must notify EPA of their export or in- should be made to: OPPT Document tended export of each subject chemical Control Office (DCO), EPA East., Rm. substance or mixture for which export 6428, Environmental Protection Agen- notice is required under § 707.60 in ac- cy, 1201 Constitution Ave., NW., Wash- cordance with the following: ington, DC (Attention: TSCA Section (1) The notice must be in writing; 12(b) Notice). The DCO is open from 8 (2)(i) The notice must be for the first a.m. to 4 p.m., Monday through Friday, export or intended export by an ex- excluding legal holidays. The telephone porter to a particular country in a cal- number for the DCO is (202) 564–8930. endar year when the chemical sub- Such deliveries are only accepted dur- stance or mixture is the subject of an ing the DCO’s normal hours of oper- order issued, an action that is pending, ation. or relief that has been granted under [45 FR 82850, Dec. 16, 1980, as amended at 53 TSCA section 5(f), a rule that has been FR 12522, Apr. 15, 1988; 58 FR 40242, July 27, proposed or promulgated under TSCA 1993; 60 FR 34463, July 3, 1995; 71 FR 33641, section 6, or an action that is pending June 12, 2006; 71 FR 66244, Nov. 14, 2006] or relief that has been granted under TSCA section 7. § 707.67 Contents of notice. (ii) The notice must only be for the The notice to EPA shall include: first export or intended export by an (a) The name of the regulated chem- exporter to a particular country when ical as it appears in the section 4, 5, 6, the chemical substance or mixture is and/or 7 action. If a category is regu- the subject of an order issued, an ac- lated, the name of the individual regu- tion that is pending, or relief that has lated chemical within that category, as been granted under TSCA section 5(e), well as the category, must be given. a rule that has been proposed or pro- The name shall be that which appears mulgated under TSCA section 5(a)(2), in Volume I of the EPA Chemical Sub- or when the submission of data is re- stance Inventory, or its supplements, if quired under TSCA section 4 or 5(b). the chemical appears there. Under this paragraph, notice of export (b) The name and address of the ex- to a particular country is not required porter. if an exporter previously submitted to (c) The country (countries) of import.

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(d) The date(s) of export or intended § 707.72 Termination of reporting re- export. quirements. (e) The section (4, 5, 6, and/or 7) of (a) The reporting requirements of TSCA under which EPA has taken ac- subpart D of this part are terminated tion. for certain specific chemical substances and mixtures as set forth in [45 FR 82850, Dec. 16, 1980, as amended at 71 this paragraph. FR 66245, Nov. 14, 2006] (1) When data required under part 766 § 707.70 EPA notice to foreign govern- of this chapter have been submitted to ments. EPA for a specific chemical substance produced by a specific process, and the (a)(1) Notice by EPA to the importing data show no positive test result as de- country shall be sent no later than 5 fined in § 766.3 of this chapter, report- working days after receipt by the ing is no longer required by persons TSCA Document Processing Center of who export or intend to export that the first annual notification from any substance produced by that process. exporter for each chemical substance (2) [Reserved] or mixture that is the subject of an (b) [Reserved] order issued, an action that is pending, [52 FR 21437, June 5, 1987] or relief that has been granted under TSCA section 5(f), a rule that has been § 707.75 Confidentiality. proposed or promulgated under TSCA (a) A person may assert a claim of section 6, or an action that is pending confidentiality for any information or relief that has been granted under which is submitted to EPA in a notice. TSCA section 7. (b) Any claim of confidentiality must (2) Notice by EPA to the importing accompany the information at the time country shall be sent no later than 5 it is submitted to EPA. In the notice, working days after receipt by the the submitter must clearly identify the TSCA Document Processing Center of information that is claimed confiden- the first notification from any exporter tial by marking the specific informa- for each chemical substance or mixture tion on each page with a label such as that is the subject of an order issued, ‘‘confidential business information’’, an action that is pending, or relief that ‘‘proprietary’’, or ‘‘trade secret’’. (c) Notwithstanding any claim of has been granted under TSCA section confidentiality, information outlined 5(e), a rule that has been proposed or in § 707.70 will be included in the EPA promulgated under TSCA section notice to the foreign government. With 5(a)(2), or for which the submission of this exception, EPA will disclose infor- data is required under TSCA section 4 mation that is covered by a claim of or 5(b). confidentiality asserted in accordance (b) Notices shall: with this section only to the extent (1) Identify the regulated chemical. permitted by, and in accordance with, (2) Summarize the regulatory action the procedures set forth in TSCA and taken, or indicate the availability of part 2 of this chapter. data under section 4 or 5(b) of TSCA. (d) If a person does not assert a claim (3) Identify an EPA official to con- of confidentiality for information at tact for further information. the time a notice is submitted to EPA, (4) Include a copy of the pertinent the Agency may make the information public, including placement in a public FEDERAL REGISTER notice. file, without further notice to the per- (c) Notices shall be sent to the coun- son. try’s ambassador in Washington, DC, or other official designated by the foreign government, and to the United PART 710—TSCA CHEMICAL States Department of State. INVENTORY REGULATIONS [45 FR 82850, Dec. 16, 1980, as amended at 58 Subpart A—General Provisions FR 40242, July 27, 1993; 71 FR 66245, Nov. 14, 2006] Sec. 710.1 Scope and compliance.

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710.3 Definitions. an initial inventory of chemical sub- 710.4 Scope of the inventory. stances manufactured, processed, or imported for commercial purposes. In Subpart B—2002 Inventory Update accordance with section 8(b), EPA peri- Reporting odically amends the inventory to in- 710.23 Definitions. clude new chemical substances which 710.25 Chemical substances for which infor- are manufactured or imported for a mation must be reported. commercial purpose and reported under 710.26 Chemical substances for which infor- section 5(a)(1) of the Act. EPA also re- mation is not required. 710.28 Persons who must report. vises the categories of chemical sub- 710.29 Persons not subject to this subpart. stances and makes other amendments 710.30 Activities for which reporting is not as appropriate. required. (b) The regulations in this part apply 710.32 Reporting information to EPA. to the activities associated with the 710.33 When to report. compilation of the TSCA Chemical In- 710.35 Duplicative reporting. ventory and the update of information 710.37 Recordkeeping requirements. 710.38 Confidentiality. on a subset of the chemical substances 710.39 How do I submit the required infor- included on the Inventory. The Inven- mation? tory Update regulations were amended in 2002; however, these amendments Subpart C—Inventory Update Reporting for apply to updates after 2002, not to the 2006 and Beyond 2002 update. In order to prevent confu- 710.43 Definitions. sion as to which regulations apply to 710.45 Chemical substances for which infor- which update, EPA has preserved the mation must be reported. provisions that apply to the 2002 up- 710.46 Chemical substances for which infor- date in subpart B. The new and revised mation is not required. requirements that apply to updates 710.48 Persons who must report. after 2002 appear in subpart C. Prior to 710.49 Persons not subject to this subpart. January 1, 2003, the regulations in sub- 710.50 Activities for which reporting is not required. part B of this part are effective for pur- 710.52 Reporting information to EPA. poses of Inventory update activities. As 710.53 When to report. of January 1, 2003, subpart C is effec- 710.55 Duplicative reporting. tive for purposes of Inventory update 710.57 Recordkeeping requirements. activities. The Agency intends to re- 710.58 Confidentiality. move subpart B from the CFR once the 710.59 Availability of reporting form and in- 2002 update is complete. structions. (c) Section 15(3) of TSCA makes it AUTHORITY: 15 U.S.C. 2607(a). unlawful for any person to fail or refuse to submit information required Subpart A—General Provisions under these reporting regulations. In addition, section 15(3) makes it unlaw- § 710.1 Scope and compliance. ful for any person to fail to keep, and (a) This part establishes regulations permit access to, records required by governing reporting and recordkeeping these regulations. Section 16 provides by certain persons who manufacture, that any person who violates a provi- import, or process chemical substances sion of section 15 is liable to the United for commercial purposes under section States for a civil penalty and may be 8(a) of the Toxic Substances Control criminally prosecuted. Pursuant to sec- Act (15 U.S.C. 2607(a)) (TSCA). Section tion 17, the Government may seek judi- 8(a) authorizes the Administrator to cial relief to compel submission of sec- require reporting of information nection 8(a) information and to otherwise essary for administration of the Act restrain any violation of section 15. and requires EPA to issue regulations (EPA does not intend to concentrate for the purpose of compiling and keep- its enforcement efforts on insignificant ing current an inventory of chemical clerical errors in reporting.) substances manufactured or processed (d) Each person who reports under for a commercial purpose, as required these regulations must maintain by section 8(b) of the Act. Following an records that document information re- initial reporting period, EPA published ported under these regulations and, in

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accordance with the Act, permit access separate from that of the article and to, and the copying of, such records by that may occur as described in EPA officials. § 710.4(d)(5); except that fluids and par- [68 FR 887, Jan. 7, 2003] ticles are not considered articles regardless of shape or design. § 710.3 Definitions. Byproduct means a chemical substance produced without separate com- In addition to the definitions in mercial intent during the manufacture § 704.3 of this chapter, the following or processing of another chemical sub- definitions apply to this part: (a) The following terms will have the stance(s) or mixture(s). meaning contained in the Federal Chemical substance means any organic Food, Drug, and Cosmetic Act, 21 or inorganic substance of a particular U.S.C. 321 et seq., and the regulations molecular identity, including any com- issued under such Act: Cosmetic, device, bination of such substances occurring drug, food, and food additive. In addi- in whole or in part as a result of a tion, the term food includes poultry chemical reaction or occurring in na- and poultry products, as defined in the ture, and any chemical element or Poultry Products Inspection Act, 21 uncombined radical; except that U.S.C. 453 et seq.; meats and meat food ‘‘chemical substance’’ does not include: products, as defined in the Federal (1) Any mixture, Meat Inspection Act, 21 U.S.C. 60 et (2) Any pesticide when manufactured, seq.; and eggs and egg products, as de- processed, or distributed in commerce fined in the Egg Products Inspection for use as a pesticide, Act, 21 U.S.C. 1033 et seq. (3) Tobacco or any tobacco product, (b) The term pesticide will have the but not including any derivative prod- meaning contained in the Federal In- ucts, secticide, Fungicide, and Rodenticide (4) Any source material, special nu- Act, 7 U.S.C. 136 et seq., and the regula- clear material, or byproduct material, tions issued thereunder. (5) Any pistol, firearm, revolver, (c) The following terms will have the shells, and cartridges, and meaning contained in the Atomic En- (6) Any food, food additive, drug, cos- ergy Act of 1954, 42 U.S.C. 2014 et seq., metic, or device, when manufactured, and the regulations issued thereunder: processed, or distributed in commerce Byproduct material, source material, and for use as a food, food additive, drug, special nuclear material. cosmetic, or device. (d) The following definitions also Commerce means trade, traffic, trans- apply to this part: portation, or other commerce: Act means the Toxic Substances Con- (1) Between a place in a State and trol Act, 15 U.S.C. 2601 et seq. any place outside of such State, or Administrator means the Adminis- (2) Which affects trade, traffic, trans- trator of the U.S. Environmental Pro- portation, or commerce described in tection Agency, any employee or au- paragraph (1) of this definition. thorized representative of the Agency Distribute in commerce and distribution to whom the Administrator may either in commerce, when used to describe an herein or by order delegate his/her au- action taken with respect to a chem- thority to carry out his/her functions, ical substance or mixture or article or any other person who will by oper- containing a substance or mixture, ation of law be authorized to carry out mean to sell or the sale of the sub- such functions. stance, mixture, or article in com- An article is a manufactured item: merce; to introduce or deliver for in- (1) Which is formed to a specific troduction into commerce, or the in- shape or design during manufacture, troduction or delivery for introduction (2) Which has end use function(s) de- into commerce of the substance, mix- pendent in whole or in part upon its ture, or article; or to hold or the hold- shape or design during end use, and ing of the substance, mixture, or arti- (3) Which has either no change of cle after its introduction into com- chemical composition during its end merce. use or only those changes of composi- EPA means the U.S. Environmental tion which have no commercial purpose Protection Agency.

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Importer means any person who im- ical reaction if the combination could ports any chemical substance or any have been manufactured for commer- chemical substance as part of a mix- cial purposes without a chemical reac- ture or article into the customs terri- tion at the time the chemical sub- tory of the U.S. and includes: stances comprising the combination (1) The person primarily liable for were combined and if, after the effec- the payment of any duties on the mer- tive date or premanufacture notifica- chandise, or tion requirements, none of the chem- (2) An authorized agent acting on his/ ical substances comprising the com- her behalf (as defined in 19 CFR 1.11). bination is a new chemical substance, Impurity means a chemical substance and which is unintentionally present with (2) Hydrates of a chemical substance another chemical substance. or hydrated ions formed by association Intermediate means any chemical sub- of a chemical substance with water. stance: New chemical substance means any (1) Which is intentionally removed chemical substance which is not in- from the equipment in which it is man- cluded in the inventory compiled and ufactured, and published under section 8(b) of the Act. (2) Which either is consumed in whole Non-isolated intermediate means any or in part in chemical reaction(s) used intermediate that is not intentionally for the intentional manufacture of removed from the equipment in which other chemical substance(s) or mix- it is manufactured, including the reac- ture(s), or is intentionally present for tion vessel in which it is manufactured, the purpose of altering the rate of such equipment which is ancillary to the re- chemical reaction(s). action vessel, and any equipment through which the substance passes NOTE: The equipment in which it was manu- during a continuous flow process, but factured includes the reaction vessel in which the chemical substance was manufactured not including tanks or other vessels in and other equipment which is strictly ancil- which the substance is stored after its lary to the reaction vessel, and any other manufacture. equipment through which the chemical sub- Person means any natural or juridical stance may flow during a continuous flow person including any individual, cor- process, but does not include tanks or other poration, partnership, or association, vessels in which the chemical substance is any State or political subdivision stored after its manufacture. thereof, or any municipality, any Manufacture means to manufacture, interstate body and any department, produce, or import for commercial pur- agency, or instrumentality of the Fed- poses. eral Government. Manufacture or import ‘‘for commercial Process means the preparation of a purposes’’ means to manufacture, chemical substance or mixture, after produce, or import with the purpose of its manufacture, for distribution in obtaining an immediate or eventual commerce: commercial advantage, and includes, (1) In the same form or physical state for example, the manufacture or im- as, or in a different form or physical port of any amount of a chemical sub- state from, that in which it was re- stance or mixture: ceived by the person so preparing such (1) For commercial distribution, in- substance or mixture, or cluding for test marketing, or (2) As part of a mixture or article (2) For use by the manufacturer, in- containing the chemical substance or cluding use for product research and mixture. development, or as an intermediate. Process ‘‘for commercial purposes’’ Mixture means any combination of means to process: two or more chemical substances if the (1) For distribution in commerce, in- combination does not occur in nature cluding for test marketing purposes, or and is not, in whole or in part, the re- (2) For use as an intermediate. sult of a chemical reaction; except that Processor means any person who proc- ‘‘mixture’’ does include: esses a chemical substance or mixture. (1) Any combination which occurs, in Site means a contiguous property whole or in part, as a result of a chem- unit. Property divided only by a public

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right-of-way will be considered one posal of the chemical substance as may site. There may be more than one man- be appropriate or required within the ufacturing plant on a single site. For scope of conducting the research and the purposes of imported chemical sub- development activity. The responsibil- stances, the site will be the business ities in this paragraph may be dele- address of the importer. gated to another individual, or other Small quantities for purposes of sci- individuals, as long as each meets the entific experimentation or analysis or criteria in paragraph (1) of this defini- chemical research on, or analysis of, such tion. substance or another substance, including Test marketing means the distribution any such research or analysis for the de- in commerce of no more than a pre- velopment of a product (hereinafter determined amount of a chemical sub- sometimes shortened to small quantities stance, mixture, or article containing for research and development) means that chemical substance or mixture, by quantities of a chemical substance a manufacturer or processor to no manufactured, imported, or processed or proposed to be manufactured, im- more than a defined number of poten- ported, or processed that: tial customers to explore market capa- (1) Are no greater than reasonably bility in a competitive situation during necessary for such purposes, and a predetermined testing period prior to (2) After the publication of the re- the broader distribution of that chem- vised inventory, are used by, or di- ical substance, mixture, or article in rectly under the supervision of, a tech- commerce. nically qualified individual(s). United States, when used in the geographic sense, means all of the States, NOTE: Any chemical substances manufactured, imported, or processed in quantities territories, and possessions of the less than 1,000 lbs. (454 kg) annually will be United States. presumed to be manufactured, imported, or [68 FR 888, Jan. 7, 2003, as amended at 69 FR processed for research and development pur- 40791, July 7, 2004] poses. No person may report for the inventory any chemical substance in such quantities unless that person can certify that the § 710.4 Scope of the inventory. substance was not manufactured, imported, (a) Chemical substances subject to these or processed solely in small quantities for re- regulations. Only chemical substances search and development, as defined in this section. which are manufactured, imported, or processed ‘‘for a commercial purpose,’’ State means any State of the United as defined in § 710.3(d), are subject to States, the District of Columbia, the these regulations. Commonwealth of Puerto Rico, the (b) Naturally occurring chemical sub- Virgin Islands, Guam, the Canal Zone, stances automatically included. Any American Samoa, the Northern Mar- chemical substance which is naturally iana Islands, or any other territory or occurring and: possession of the United States. (1) Which is (i) unprocessed or (ii) Technically qualified individual means a person: processed only by manual, mechanical, (1) Who because of his/her education, or gravitational means; by dissolution training, or experience, or a combina- in water; by flotation; or by heating tion of these factors, is capable of ap- solely to remove water; or preciating the health and environ- (2) Which is extracted from air by mental risks associated with the chem- any means, will automatically be in- ical substance which is used under his/ cluded in the inventory under the cather supervision, egory ‘‘Naturally Occurring Chemical (2) Who is responsible for enforcing Substances.’’ Examples of such sub- appropriate methods of conducting sci- stances are: raw agricultural commod- entific experimentation, analysis, or ities; water, air, natural gas, and crude chemical research in order to minimize oil; and rocks, ores, and minerals. such risks, and (c) Substances excluded by definition or (3) Who is responsible for the safety section 8(b) of TSCA. The following sub- assessments and clearances related to stances are excluded from the inven- the procurement, storage, use, and dis- tory:

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(1) Any substance which is not con- (4) Any chemical substance which re- sidered a ‘‘chemical substance’’ as pro- sults from a chemical reaction that oc- vided in subsection 3(2)(B) of the Act curs incidental to storage of another and in the definition of ‘‘chemical sub- chemical substance, mixture, or arti- stance’’ in § 710.3(d); cle. (2) Any mixture as defined in (5) Any chemical substance which re- § 710.3(d); sults from a chemical reaction that oc- NOTE: A chemical substance that is manu- curs upon end use of other chemical factured as part of a mixture is subject to substances, mixtures, or articles such these reporting regulations. This exclusion as adhesives, paints, miscellaneous applies only to the mixture and not to the chemical substances of which the mixture is cleansers or other housekeeping prod- comprised. The term ‘‘mixture’’ includes al- ucts, fuels and fuel additives, water loys, inorganic glasses, ceramics, frits, and softening and treatment agents, photo- cements, including Portland cement. graphic films, batteries, matches, and (3) Any chemical substance which is safety flares, and which is not itself manufactured, imported, or processed manufactured for distribution in com- solely in small quantities for research merce or for use as an intermediate. and development, as defined in (6) Any chemical substance which re- § 710.3(d); and sults from a chemical reaction that oc- (4) Any chemical substance not man- curs upon use of curable plastic or rub- ufactured, processed or imported for a ber molding compounds, inks, drying commercial purpose since January 1, oils, metal finishing compounds, adhe- 1975. sives, or paints; or other chemical sub- (d) Chemical substances excluded from stances formed during manufacture of the inventory. The following chemical an article destined for the marketplace substances are excluded from the in- without further chemical change of the ventory. Although they are considered chemical substance except for those to be manufactured or processed for a chemical changes that may occur as commercial purpose for the purpose of described elsewhere in this § 710.4(d). section 8 of the Act, they are not man- (7) Any chemical substance which re- ufactured or processed for distribution in commerce as chemical substances sults from a chemical reaction that oc- per se and have no commercial purpose curs when (i) a stabilizer, colorant, separate from the substance, mixture, odorant, antioxidant, filler, solvent, or article of which they may be a part. carrier, surfactant, plasticizer, corro- NOTE: In addition, chemical substances ex- sion inhibitor, antifoamer or de-foam- cluded here will not be subject to er, dispersant, precipitation inhibitor, premanufacture notification under section 5 binder, emulsifier, de-emulsifier, of the Act. dewatering agent, agglomerating (1) Any impurity. agent, adhesion promoter, flow modi- (2) Any byproduct which has no com- fier, pH neutralizer, sequesterant, co- mercial purpose. agulant, flocculant, fire retardant, lu- NOTE: A byproduct which has commercial bricant, chelating agent, or quality value only to municipal or private organiza- control reagent functions as intended tions who (i) burn it as a fuel, (ii) dispose of or (ii) a chemical substance, solely in- it as a waste, including in a landfill or for enriching soil, or (iii) extract component tended to impart a specific physicochemical substances which have commercial chemical characteristic, functions as value, may be reported for the inventory, but intended. will not be subject to premanufacture notifi- (8) Chemical substances which are cation under section 5 of the Act if not in- not intentionally removed from the cluded. equipment in which they were manu- (3) Any chemical substance which re- factured. sults from a chemical reaction that oc- NOTE: See note to definition of ‘‘inter- curs incidental to exposure of another mediate’’ at § 710.3(d) for explanation of chemical substance, mixture, or article ‘‘equipment in which it was manufactured.’’ to environmental factors such as air, moisture, microbial organisms, or sun- [42 FR 64572, Dec. 23, 1977, as amended at 68 light. FR 889, Jan. 7, 2003]

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Subpart B—2002 Inventory Update reporting requirements of this subpart Reporting if that substance is the subject of a rule proposed or promulgated under § 710.23 Definitions. section 4, 5(a)(2), 5(b)(4), or 6 of the Act, In addition to the definitions in or is the subject of an order issued § 704.3 of this chapter and § 710.3, the under section 5(e) or 5(f) of the Act, or following definitions also apply to sub- is the subject of relief that has been part B of this part. granted under a civil action under sec- Master Inventory File means EPA’s tion 5 or 7 of the Act. comprehensive list of chemical sub- (a) Inorganic chemical substances. Any stances which constitute the Chemical chemical substance which does not Substances Inventory compiled under contain carbon or contains carbon only section 8(b) of the Act. It includes sub- in the form of carbonato [=CO3], cyano ¥ ¥ stances reported under subpart A of [ CN], cyanato [ OCN], isocyano ¥ ¥ this part and substances reported [ NC], or isocyanato [ NCO] groups, under part 720 of this chapter for which or the chalcogen analogues of such a Notice of Commencement of Manu- groups. facture or Import has been received (b) Polymers. (1) Any chemical sub- under § 720.120 of this chapter. stance described with the word frag- Non-isolated intermediate means any ments ‘‘*polym*’’, ‘‘*alkyd’’, or intermediate that is not intentionally ‘‘*oxylated’’ in the Chemical Abstracts removed from the equipment in which Service Index or Preferred Nomen- it is manufactured, including the reac- clature in the Chemical Substance tion vessel in which it is manufactured, Identities section of the 1985 edition of equipment which is ancillary to the re- the Inventory or in the Master Inven- action vessel, and any equipment tory File, where the asterisk (*) indi- through which the substance passes cates that any sets of characters may during a continuous flow process, but precede, or follow, the character string not including tanks or other vessels in defined. which the substance is stored after its (2) Any chemical substance which is manufacture. identified in the 1985 edition of the In- Site-limited means a chemical sub- ventory or the Master Inventory File stance is manufactured and processed as siloxane and silicone, only within a site and is not distrib- silsesquioxane, a protein (albumin, ca- uted for commercial purposes as a sub- sein, gelatin, gluten, hemoglobin), an stance or as part of a mixture or arti- enzyme, a polysaccharide (starch, cel- cle outside the site. Imported sub- lulose, gum), rubber, or lignin. This ex- stances are never site-limited. clusion, however, does not apply to a chemical substance which has been [68 FR 889, Jan. 7, 2003] hydrolyzed, depolymerized, or chemically modified to the extent that the § 710.25 Chemical substances for final product is no longer polymeric in which information must be reported. structure. (c) Microorganisms. Any combination Any chemical substance which is in of chemical substances that is a living the Master Inventory File at the begin- organism, such as bacteria, eimeria, ning of a reporting period described in fungi, and yeasts. Any chemical sub- § 710.33, unless the chemical substance stance produced from such a living or- is specifically excluded by § 710.26. ganism is reportable unless otherwise [51 FR 21447, June 12, 1986] excluded. (d) Naturally occurring chemical sub- § 710.26 Chemical substances for stances. Any naturally occurring chem- which information is not required. ical substance, as described in § 710.4(b). The following categories of chemical The applicability of this exclusion is substances are excluded from the re- determined in each case by the specific porting requirements of this subpart. activities of the person who manufac- However, a chemical substance de- tures the substance in question. Some scribed in paragraphs (a), (b), or (c) of chemical substances can be manufac- this section is not excluded from the tured both as described in § 710.4(b) and

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by means other than those described in § 710.29 Persons not subject to this § 710.4(b). If a person described in subpart. § 710.28 manufactures a chemical sub- A person described in § 710.28 is not stance by means other than those de- subject to the requirements of this sub- scribed in § 710.4(b), the person must re- part if that person qualifies as a small port regardless of whether the sub- manufacturer as that term is defined in stance also could have been produced § 704.3 of this chapter. Notwithstanding as described in § 710.4(b). Any chemical this exclusion, a person who qualifies substance that is produced from such a as a small manufacturer is subject to naturally occurring chemical sub- this subpart with respect to any chem- stance described in § 710.4(b) is report- ical substance that is the subject of a able unless otherwise excluded. rule proposed or promulgated under section 4, 5(b)(4), or 6 of the Act, or is [51 FR 21447, June 12, 1986] the subject of an order in effect under section 5(e) of the Act, or is the subject § 710.28 Persons who must report. of relief that has been granted under a Except as provided in §§ 710.29 and civil action under section 5 or 7 of the 710.30, the following persons are subject Act. to the requirements of this subpart. [51 FR 21447, June 12, 1986] Persons must determine whether they must report under this § 710.28 for each § 710.30 Activities for which reporting chemical substance that they manufac- is not required. ture at an individual site. A person described in § 710.28 is not (a) Persons subject to initial reportinq. subject to the requirements of this sub- Any person who manufactured for compart with respect to any chemical sub- mercial purposes 10,000 pounds (4,540 stance described in § 710.25 that the per- kilograms) or more of a chemical sub- son manufactured or imported under stance described in § 710.25 at any sin- the following circumstances: gle site owned or controlled by that (a) The person manufactured or im- person at any time during the person’s ported the chemical substance de- latest complete corporate fiscal year scribed in § 710.25 solely in small quan- before August 25, 1986. tities for research and development, (b) Persons subject to recurring report- (b) The person imported the chemical ing. Any person who manufactured for substance described in § 710.25 as part of commercial purposes 10,000 pounds an article, (4,540 kilograms) or more of a chemical (c) The person manufactured the substance described in § 710.25 at any chemical substance described in § 710.25 single site owned or controlled by that in a manner described in § 720.30(g) or person at any time during the person’s (h) of this chapter. latest complete corporate fiscal year [51 FR 21447, June 12, 1986] before August 25, 1990, or before August 25 at four-year intervals thereafter. § 710.32 Reporting information to EPA. (c) Special provisions for importers. For Any person who must report under purposes of paragraphs (a) and (b) of this part must submit the information this section, the site for a person who prescribed in this section for each imports a chemical substance described chemical substance described in § 710.25 in § 710.25 is the site of the operating that the person manufactured for com- unit within the person’s organization mercial purposes in an amount of 10,000 which is directly responsible for im- pounds (4,540 kilograms) or more at a porting the substance and which con- single site during a corporate fiscal trols the import transaction. The im- year described in § 710.28. (The site for a port site may in some cases be the or- person who imports a chemical sub- ganization’s headquarters in the U.S. stance is the site of the operating unit (See also § 710.35(b).) within the person’s organization which is directly responsible for importing [51 FR 21447, June 12, 1986] the substance and which controls the import transaction, and may in some

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cases be the organization’s head- this subpart may use other chemical quarters office in the U.S.). A respond- identification numbers in lieu of CAS ent to this subpart must report infor- Registry Numbers when a CAS Reg- mation in writing or by magnetic istry Number is not known to the re- media as prescribed in this section, to spondent as provided in the instruction the extent that such information is booklet identified in § 710.39(b), includ- known to or reasonably ascertainable ing EPA-designated Accession Numbers by that person. A respondent to this for confidential substances, EPA-as- subpart must report information that signed numbers for bona fide or applies to the specific corporate fiscal Premanufacture Notification submis- year for which the person is required to sions, or Test Market Exemption Ap- report. plications, or original Inventory form (a) Reporting in writing. Any person numbers. who chooses to report information to (4) The name, street address, city, EPA in writing must do so by com- State, and Zip code of each site at pleting the reporting form available which 10,000 pounds (4,540 kilograms) or from EPA at the address set forth in more of a chemical substance for which § 710.39(b). The form must include all reporting is required under this sub- information prescribed in paragraph (c) part is manufactured or imported. (The of this section. Persons reporting in site for a person who imports a chem- writing must submit a separate form ical substance is the site of the oper- for each site for which the person is re- ating unit within the person’s organi- quired to report. zation which is directly responsible for (b) Reporting by magnetic media. Any importing the substance and which person who chooses to report informa- controls the import transaction, and tion to EPA by means of magnetic may in some cases be the organiza- media must submit the information tion’s headquarters office in the U.S.) prescribed in paragraph (c) of this sec- A respondent to this subpart must in- tion. Magnetic media submitted in re- clude the appropriate Dun and Brad- sponse to this subpart must meet EPA street Number for each plant site re- specifications, as described in the in- ported. struction booklet available from EPA (5) A statement for each substance at the address set forth in § 710.39(b). for which information is being sub- (c) Information to be reported. Persons mitted indicating whether the sub- reporting information under this substance is manufactured in the United part must report the following: States or imported into the United (1) The name, company, address, city, States. State, Zip code, and telephone number (6) A statement for each substance of a person who will serve as technical for which information is being sub- contact for the respondent company, mitted indicating whether the sub- and will be able to answer questions stance is site-limited. about the information submitted by (7) The total volume (in pounds) of the company to EPA. Persons report- each subject chemical substance manu- ing by means of magnetic media must factured or imported at each site. This submit this information on the report- amount must be reported to two sig- ing form available from EPA at the ad- nificant figures of accuracy provided dress set forth in § 710.39. that the reported figures are within ±10 (2) A certification statement signed percent of the actual volume. and dated by an authorized official of the respondent company. Persons re- [55 FR 39587, Sept. 27, 1990, as amended at 60 porting by means of magnetic media FR 31921, June 19, 1995] must submit this information on the reporting form available from EPA at § 710.33 When to report. the address set forth in § 710.39. All information reported to EPA in (3) The specific chemical name and response to the requirements of this Chemical Abstracts Service (CAS) Reg- subpart must be submitted during an istry Number of each chemical sub- applicable reporting period. The fol- stance for which reporting is required lowing reporting periods are prescribed under this subpart. A respondent to for this subpart.

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(a) Initial reporting period. The first chapter, they may determine among reporting period is from August 25, 1986 themselves who should submit the re- to December 23, 1986. Any person de- quired report; if no report is submitted scribed in § 710.28(a) must report during as required under this part, EPA will this period for each chemical substance hold each such person liable for failure described in § 710.25 that the person to report. manufactured during the corporate fiscal year described in § 710.28(a). [51 FR 21447, June 12, 1986, as amended at 60 (b) Recurring reporting periods. The FR 31921, June 19, 1995] first recurring reporting period is from § 710.37 Recordkeeping requirements. August 25, 1990 to December 23, 1990. Subsequent reporting periods, except Each person who is subject to the re- as provided in paragraph (c) of this sec- porting requirements of this part must tion, are from August 25 to December maintain records that document any 23 at 4-year intervals thereafter. Any information reported to EPA. For sub- person described in § 710.28(b) must re- stances that are manufactured or import during the appropriate reporting ported at less than 10,000 pounds annu- period for each chemical substance de- ally, volume records must be main- scribed in § 710.25 that the person man- tained as evidence to support a deci- ufactured during the applicable cor- sion not to submit a report. Records porate fiscal year described in relevant to reporting during a report- § 710.28(b). ing period described in § 710.33 must be (c) Reporting in 1998. The 1998 report- retained for a period of four years being period is from August 25, 1998 until ginning with the effective date of that January 31, 1999. Any person described reporting period. in § 710.28(b) must report during this reporting period for each chemical sub- [51 FR 21447, June 12, 1986, as amended at 58 stance described in § 710.25 that the per- FR 34204, June 23, 1993; 60 FR 31921, June 19, 1995] son manufactured during the applicable corporate fiscal year described in § 710.38 Confidentiality. § 710.28(b). This reporting period is applicable to 1998 reporting only. (a) Any person submitting information under this part may assert a busi- [51 FR 21447, June 12, 1986: 51 FR 22521, June ness confidentiality claim for the in- 20, 1986, as amended at 63 FR 71600, Dec. 29, 1998] formation. The procedures for asserting confidentiality claims are de- § 710.35 Duplicative reporting. scribed in the instruction booklet iden- (a) With regard to section 8(a) rules. tified in § 710.39. Information claimed Any person subject to the requirements as confidential in accordance with this of this part who previously has com- section and those instructions will be plied with reporting requirements of a treated and disclosed in accordance rule under section 8(a) of the Act by with the procedures in part 2 of this submitting the information described chapter. in § 710.32 for a chemical substance de- (b) A person may assert a claim of scribed in § 710.25 to EPA, and has done confidentiality for the chemical iden- so within one year of the start of a re- tity of a specific chemical substance porting period described in § 710.33, is only if the identity of that substance is not required to report again on the treated as confidential in the Master manufacture of that substance at that Inventory File as of the time the re- site during that reporting period. port is submitted for that substance (b) With regard to importers. This part under this part. requires that only one report be sub- (c) To assert a claim of confiden- mitted on each import transaction in- tiality for the chemical identity of a volving a chemical substance described specific chemical substance, the person in § 710.25. When two or more persons must take the following steps: are involved in a particular import (1) The person must submit with the transaction and each person meets the report detailed written answers to the Agency’s definition of ‘‘importer’’ as following questions signed and dated set forth in §§ 710.2(l) and 704.3 of this by an authorized official.

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(i) What harmful effects to your com- (x) For what purpose do you manu- petitive position, if any, do you think facture or import the substance? would result from the identity of the (xi) Has EPA, another Federal agen- chemical substance being disclosed in cy, or any Federal court made any per- connection with reporting under this tinent confidentiality determinations part? How could a competitor use such regarding this chemical substance? If information? Would the effects of dis- so, please attach copies of such deter- closure be substantial? What is the minations. causal relationship between the disclo- (2) If any of the information con- sure and the harmful effects? tained in the answers to the questions (ii) How long should confidential is asserted to contain confidential busi- treatment be given? Until a specific ness information, the person must date, the occurrence of a specific event, mark that information as ‘‘trade se- or permanently? Why? cret,’’ ‘‘confidential,’’ or other appro- (iii) Has the chemical substance been priate designation. patented? If so, have you granted li- (d) If no claim of confidentiality ac- censes to others with respect to the companies information at the time it is submitted to EPA under this part or if patent as it applies to the chemical substantiation required under para- substance? If the chemical substance graph (c) of this section is not sub- has been patented and therefore dis- mitted with the reporting form, EPA closed through the patent, why should may make the information available to it be treated as confidential? the public without further notice to (iv) Has the identity of the chemical the submitter. substance been kept confidential to the extent that your competitors do not [51 FR 21447, June 12, 1986, as amended at 55 know it is being manufactured or im- FR 39588, Sept. 27, 1990; 60 FR 31921, June 19, ported for a commercial purpose by 1995] anyone? § 710.39 How do I submit the required (v) Is the fact that the chemical sub- information? stance is being manufactured or im- (a) Use the proper EPA form. You must ported for a commercial purpose avail- use the EPA form identified as ‘‘Form able to the public, for example in tech- U’’ to submit written information in nical journals, libraries, or State, response to the requirements of this local, or Federal agency public files? subpart. Copies of the Form U are (vi) What measures have you taken available from EPA at the address set to prevent undesired disclosure of the forth in paragraph (c) of this section fact that this chemical substance is and from the EPA Internet Home Page being manufactured or imported for a at http://www.epa.gov/oppt/iur/iur02/ commercial purpose? index.htm. (vii) To what extent has the fact that (b) Follow the reporting instructions. this chemical substance is manufac- You should follow the detailed instruc- tured or imported for commercial pur- tions for completing the reporting form poses been revealed to others? What and preparing a magnetic media report, precautions have been taken regarding which are given in the EPA publication these disclosures? Have there been pub- entitled ‘‘Instructions for Reporting lic disclosures or disclosures to com- for Partial Updating of the TSCA petitors? Chemical Inventory Data Base,’’ via (viii) Does this particular chemical the Internet or the TSCA Hotline. substance leave the site of manufac- (c) Obtain the reporting package and ture in any form, as product, effluent, copies of the form. EPA is mailing the emission, etc.? If so, what measures reporting package to those companies have you taken to guard against dis- that reported in 1998. Failure to receive covery of its identity? a reporting package does not obviate or (ix) If the chemical substance leaves otherwise affect the requirement to the site in a product that is available submit a timely report. If you did not to the public or your competitors, can receive a reporting package, but are re- the substance be identified by analysis quired to report, you may obtain a of the product? copy of the reporting package and the

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reporting form from EPA by submit- or mixtures are manufactured (includ- ting a request for this information as ing imported) or processed. follows: Intended for use by children means the (1) By phone. Call the EPA TSCA chemical substance or mixture is used Hotline at (202) 554–1404. in or on a product that is specifically (2) By e-mail. Send an e-mail request intended for use by children age 14 or for this information to the EPA TSCA younger. A chemical substance or mix- Hotline at TSCA- ture is intended for use by children [email protected]. when the submitter answers ‘‘yes’’ to (3) By mail. Send a written request at least one of the following questions for this information to the following for the product into which the submit- address: TSCA Hotline, Mail Code ter’s chemical substance or mixture is 7408M, ATTN: Inventory Update Rule, incorporated: Office of Pollution Prevention and (1) Is the product commonly recog- Toxics, U.S. Environmental Protection nized (i.e., by a reasonable person) as Agency, 1200 Pennsylvania Ave., NW., being intended for children age 14 or Washington, DC 20460. younger? (d) Submit the completed reports. You (2) Does the manufacturer of the must submit your completed reporting product state through product labeling form(s) and/or magnetic media to EPA or other written materials that the at the following address: OPPT Docu- product is intended for or will be used ment Control Officer, Mail Code 7407M, by children age 14 or younger? ATTN: Inventory Update Rule, Office (3) Is the advertising, promotion, or of Pollution Prevention and Toxics, marketing of the product aimed at U.S. Environmental Protection Agen- children age 14 or younger? cy, 1200 Pennsylvania Ave., NW., Wash- Known to or reasonably ascertainable ington, DC 20460. by means all information in a person’s possession or control, plus all informa- [63 FR 45953, Aug. 28, 1998, as amended at 68 tion that a reasonable person similarly FR 890, Jan. 7, 2003] situated might be expected to possess, control, or know. Subpart C—Inventory Update Master Inventory File means EPA’s Reporting for 2006 and Beyond comprehensive list of chemical substances which constitute the Chemical Substances Inventory compiled under SOURCE: 68 FR 890, Jan. 7, 2003, unless oth- section 8(b) of the Act. It includes sub- erwise noted. stances reported under subpart A of § 710.43 Definitions. this part and substances reported under part 720 of this chapter for which In addition to the definitions in a Notice of Commencement of Manu- § 704.3 of this chapter and § 710.3, the facture or Import has been received following definitions also apply to sub- under § 720.120 of this chapter. part C of this part: Readily obtainable information means Commercial use means the use of a information which is known by man- chemical substance or mixture in a agement and supervisory employees of commercial enterprise providing sale- the submitter company who are re- able goods or services (e.g., dry clean- sponsible for manufacturing, proc- ing establishment, painting con- essing, distributing, technical services, tractor). and marketing of the reportable chem- Consumer use means the use of a ical substance. Extensive file searches chemical substance that is directly, or are not required. as part of a mixture, sold to or made Reasonably likely to be exposed means available to consumers for their use in an exposure to a chemical substance or around a permanent or temporary which, under foreseeable conditions of household or residence, in or around a manufacture (including import), proc- school, or in or around recreational essing, distribution in commerce, or areas. use of the chemical substance, is more Industrial use means use at a site at likely to occur than not to occur. Such which one or more chemical substances exposures would normally include, but

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would not be limited to, activities such § 710.45 Chemical substances for as charging reactor vessels, drumming, which information must be re- bulk loading, cleaning equipment, ported. maintenance operations, materials Any chemical substance which is in handling and transfers, and analytical the Master Inventory File at the begin- operations. Covered exposures include ning of a submission period described exposures through any route of entry in § 710.53, unless the chemical sub- (inhalation, ingestion, skin contact, stance is specifically excluded by absorption, etc.), but excludes acci- § 710.46. dental or theoretical exposures. Repackaging means the physical § 710.46 Chemical substances for transfer of a chemical substance or which information is not required. mixture, as is, from one container to The following groups or categories of another container or containers in chemical substances are exempted preparation for distribution of the from some or all of the reporting re- chemical substance or mixture in com- quirements of this subpart, with the merce. following exception: A chemical sub- Reportable chemical substance means a stance described in paragraph (a)(1), chemical substance described in (a)(2), or (a)(4), or (b) of this section is § 710.45. not exempted from any of the reporting Reporting year means the calendar requirements of this subpart if that year in which information to be re- substance is the subject of a rule proposed or promulgated under section 4, ported to EPA during an IUR submis- 5(a)(2), 5(b)(4), or 6 of the Act, or is the sion period is generated, i.e., calendar subject of an order issued under section year 2005 and the calendar year at 5– 5(e) or 5(f) of the Act, or is the subject year intervals thereafter. of relief that has been granted under a Site-limited means a chemical sub- civil action under section 5 or 7 of the stance is manufactured and processed Act. only within a site and is not distrib- (a) Full exemptions. The following cat- uted for commercial purposes as a sub- egories of chemical substances are ex- stance or as part of a mixture or arti- empted from the reporting require- cle outside the site. Imported sub- ments of this subpart. stances are never site-limited. Al- (1) Polymers. (i) Any chemical sub- though a site-limited chemical substance described with the word frag- stance is not distributed for commer- ments ‘‘*polym*’’, ‘‘*alkyd’’, or cial purposes outside the site at which ‘‘*oxylated’’ in the Chemical Abstracts it is manufactured and processed, the Service Index or Preferred Nomen- substance is considered to have been clature in the Chemical Substance manufactured and processed for com- Identities section of the Master Inven- mercial purposes. tory File, where the asterisk (*) indi- Submission period means the period in cates that any sets of characters may which the information generated dur- precede, or follow, the character string ing the reporting year is submitted to defined. EPA. (ii) Any chemical substance which is Use means any utilization of a chem- identified in the Master Inventory File ical substance or mixture that is not as siloxane and silicone, otherwise covered by the terms manu- silsesquioxane, a protein (albumin, ca- facture or process. Relabeling or redis- sein, gelatin, gluten, hemoglobin), an enzyme, a polysaccharide (starch, cel- tributing a container holding a chem- lulose, gum), rubber, or lignin. ical substance or mixture where no repackaging of the chemical substance or (iii) This exclusion does not apply to a polymeric substance that has been mixture occurs does not constitute use hydrolyzed, depolymerized, or other- or processing of the chemical substance wise chemically modified, except in or mixture. cases where the intended product of [68 FR 890, Jan. 7, 2003, as amended at 69 FR this reaction is totally polymeric in 40791, July 7, 2004; 70 FR 75068, Dec. 19, 2005] structure.

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(2) Microorganisms. Any combination subpart must be reported), unless oth- of chemical substances that is a living erwise exempted. organism, and that meets the defini- (1) Petroleum process streams. EPA has tion of ‘‘microorganism’’ at § 725.3 of designated the following chemical sub- this chapter. Any chemical substance stances, listed by CAS Number, as par- produced from a living microorganism tially exempt from reporting under the is reportable under this subpart unless IUR. otherwise excluded. (3) Naturally occurring chemical sub- CAS NUMBERS OF PARTIALLY EXEMPT CHEM- ICAL SUBSTANCES TERMED ‘‘PETROLEUM stances. Any naturally occurring chem- PROCESS STREAMS’’ FOR PURPOSES OF IN- ical substance, as described in § 710.4(b). VENTORY UPDATE REPORTING The applicability of this exclusion is determined in each case by the specific CAS No. Product activities of the person who manufac- 7732–18–5 Water tures the substance in question. Some 8002–05–9 Petroleum chemical substances can be manufac- 8002–74–2 Paraffin waxes and hydrocarbon waxes tured both as described in § 710.4(b) and 8006–20–0 Fuel gases, low and medium B.T.U. 8008–20–6 Kerosine (petroleum) by means other than those described in 8009–03–8 Petrolatum § 710.4(b). If a person described in 8012–95–1 Paraffin oils § 710.48 manufactures a chemical sub- 8030–30–6 Naphtha 8032–32–4 Ligroine stance by means other than those de- 8042–47–5 White mineral oil (petroleum) scribed in § 710.4(b), the person must re- 8052–41–3 Stoddard solvent port regardless of whether the sub- 8052–42–4 Asphalt 61789–60–4 Pitch stance also could have been produced 63231–60–7 Paraffin waxes and hydrocarbon waxes, as described in § 710.4(b). Any chemical microcryst. substance that is produced from such a 64741–41–9 Naphtha (petroleum), heavy straight-run naturally occurring chemical sub- 64741–42–0 Naphtha (petroleum), full-range straight-run 64741–43–1 Gas oils (petroleum), straight-run stance described in § 710.4(b) is report- 64741–44–2 Distillates (petroleum), straight-run middle able unless otherwise excluded. 64741–45–3 Residues (petroleum), atm. tower (4) Certain forms of natural gas. Chem- 64741–46–4 Naphtha (petroleum), light straight-run 64741–47–5 Natural gas condensates (petroleum) ical substances with the following 64741–49–7 Condensates (petroleum), vacuum tower Chemical Abstract Service (CAS) Reg- 64741–50–0 Distillates (petroleum), light paraffinic istry Numbers: CAS No. 64741–48–6, Nat- 64741–51–1 Distillates (petroleum), heavy paraffinic 64741–52–2 Distillates (petroleum), light naphthenic ural gas (petroleum), raw liquid mix; 64741–53–3 Distillates (petroleum), heavy naphthenic CAS No. 68919–39–1, Natural gas conden- 64741–54–4 Naphtha (petroleum), heavy catalytic sates; CAS No. 8006–61–9, Gasoline nat- cracked 64741–55–5 Naphtha (petroleum), light catalytic cracked ural; CAS No. 68425–31–0, Gasoline (nat- 64741–56–6 Residues (petroleum), vacuum ural gas), natural; CAS No. 8006–14–2, 64741–57–7 Gas oils (petroleum), heavy vacuum Natural gas; and CAS No. 68410–63–9, 64741–58–8 Gas oils (petroleum), light vacuum Natural gas, dried. 64741–59–9 Distillates (petroleum), light catalytic cracked (b) Partial exemptions. The following 64741–60–2 Distillates (petroleum), intermediate cata- groups of chemical substances are par- lytic cracked tially exempted from the reporting re- 64741–61–3 Distillates (petroleum), heavy catalytic cracked quirements of this subpart (i.e., the in- 64741–62–4 Clarified oils (petroleum), catalytic cracked formation described in § 710.52(c)(4) 64741–63–5 Naphtha (petroleum), light catalytic re- need not be reported for these sub- formed 64741–64–6 Naphtha (petroleum), full-range alkylate stances). Such chemical substances are 64741–65–7 Naphtha (petroleum), heavy alkylate not excluded from the other reporting 64741–66–8 Naphtha (petroleum), light alkylate requirements under this subpart. A 64741–67–9 Residues (petroleum), catalytic reformer fractionator chemical substance described in para- 64741–68–0 Naphtha (petroleum), heavy catalytic re- graph (b)(3) of this section qualifies for formed a partial reporting exemption during 64741–69–1 Naphtha (petroleum), light hydrocracked the 2006 submission period; in subse- 64741–70–4 Naphtha (petroleum), isomerization 64741–73–7 Distillates (petroleum), alkylate quent submission periods, the chemical 64741–74–8 Naphtha (petroleum), light thermal cracked substances described in paragraph 64741–75–9 Residues (petroleum), hydrocracked (b)(3) of this section will be subject to 64741–76–0 Distillates (petroleum), heavy hydrocracked 64741–77–1 Distillates (petroleum), light hydrocracked full reporting under this subpart (i.e., 64741–78–2 Naphtha (petroleum), heavy hydrocracked all of the information described in this 64741–79–3 Coke (petroleum)

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CAS NUMBERS OF PARTIALLY EXEMPT CHEM- CAS NUMBERS OF PARTIALLY EXEMPT CHEM- ICAL SUBSTANCES TERMED ‘‘PETROLEUM ICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR PURPOSES OF IN- PROCESS STREAMS’’ FOR PURPOSES OF IN- VENTORY UPDATE REPORTING—Continued VENTORY UPDATE REPORTING—Continued

CAS No. Product CAS No. Product

64741–80–6 Residues (petroleum), thermal cracked 64742–27–4 Distillates (petroleum), chemically neutral- 64741–81–7 Distillates (petroleum), heavy thermal ized heavy paraffinic cracked 64742–28–5 Distillates (petroleum), chemically neutral- 64741–82–8 Distillates (petroleum), light thermal ized light paraffinic cracked 64742–29–6 Gas oils (petroleum), chemically neutral- 64741–83–9 Naphtha (petroleum), heavy thermal ized cracked 64742–30–9 Distillates (petroleum), chemically neutral- 64741–84–0 Naphtha (petroleum), solvent-refined light ized middle 64741–85–1 Raffinates (petroleum), sorption process 64742–31–0 Distillates (petroleum), chemically neutral- 64741–86–2 Distillates (petroleum), sweetened middle ized light 64741–87–3 Naphtha (petroleum), sweetened 64742–32–1 Lubricating oils (petroleum), chemically 64741–88–4 Distillates (petroleum), solvent-refined neutralized spent heavy paraffinic 64742–33–2 Hydrocarbon waxes (petroleum), chemi- 64741–89–5 Distillates (petroleum), solvent-refined light cally neutralized paraffinic 64742–34–3 Distillates (petroleum), chemically neutral- 64741–90–8 Gas oils (petroleum), solvent-refined ized heavy naphthenic 64741–91–9 Distillates (petroleum), solvent-refined mid- 64742–35–4 Distillates (petroleum), chemically neutral- dle ized light naphthenic 64741–92–0 Naphtha (petroleum), solvent-refined heavy 64742–36–5 Distillates (petroleum), clay-treated heavy 64741–95–3 Residual oils (petroleum), solvent paraffinic deasphalted 64742–37–6 Distillates (petroleum), clay-treated light 64741–96–4 Distillates (petroleum), solvent-refined paraffinic heavy naphthenic 64741–97–5 Distillates (petroleum), solvent-refined light 64742–38–7 Distillates (petroleum), clay-treated middle naphthenic 64742–39–8 Neutralizing agents (petroleum), spent so- 64741–98–6 Extracts (petroleum), heavy naphtha soldium carbonate vent 64742–40–1 Neutralizing agents (petroleum), spent so- 64741–99–7 Extracts (petroleum), light naphtha solvent dium hydroxide 64742–01–4 Residual oils (petroleum), solvent-refined 64742–41–2 Residual oils (petroleum), clay-treated 64742–03–6 Extracts (petroleum), light naphthenic dis- 64742–42–3 Hydrocarbon waxes (petroleum), clay-treat- tillate solvent ed microcryst. 64742–04–7 Extracts (petroleum), heavy paraffinic dis- 64742–43–4 Paraffin waxes (petroleum), clay-treated tillate solvent 64742–44–5 Distillates (petroleum), clay-treated heavy 64742–05–8 Extracts (petroleum), light paraffinic dis- naphthenic tillate solvent 64742–45–6 Distillates (petroleum), clay-treated light 64742–06–9 Extracts (petroleum), middle distillate sol- naphthenic vent 64742–46–7 Distillates (petroleum), hydrotreated middle 64742–07–0 Raffinates (petroleum), residual oil 64742–47–8 Distillates (petroleum), hydrotreated light decarbonization 64742–48–9 Naphtha (petroleum), hydrotreated heavy 64742–08–1 Raffinates (petroleum), heavy naphthenic 64742–49–0 Naphtha (petroleum), hydrotreated light distillate decarbonization 64742–50–3 Lubricating oils (petroleum), clay-treated 64742–09–2 Raffinates (petroleum), heavy paraffinic dis- spent tillate decarbonization 64742–51–4 Paraffin waxes (petroleum), hydrotreated 64742–10–5 Extracts (petroleum), residual oil solvent 64742–52–5 Distillates (petroleum), hydrotreated heavy 64742–11–6 Extracts (petroleum), heavy naphthenic dis- naphthenic tillate solvent 64742–53–6 Distillates (petroleum), hydrotreated light 64742–12–7 Gas oils (petroleum), acid-treated naphthenic 64742–13–8 Distillates (petroleum), acid-treated middle 64742–54–7 Distillates (petroleum), hydrotreated heavy 64742–14–9 Distillates (petroleum), acid-treated light paraffinic 64742–15–0 Naphtha (petroleum), acid-treated 64742–55–8 Distillates (petroleum), hydrotreated light 64742–16–1 Petroleum resins paraffinic 64742–18–3 Distillates (petroleum), acid-treated heavy 64742–56–9 Distillates (petroleum), solvent-dewaxed naphthenic light paraffinic 64742–19–4 Distillates (petroleum), acid-treated light 64742–57–0 Residual oils (petroleum), hydrotreated naphthenic 64742–58–1 Lubricating oils (petroleum), hydrotreated 64742–20–7 Distillates (petroleum), acid-treated heavy spent paraffinic 64742–59–2 Gas oils (petroleum), hydrotreated vacuum 64742–21–8 Distillates (petroleum), acid-treated light 64742–60–5 Hydrocarbon waxes (petroleum), paraffinic hydrotreated microcryst. 64742–22–9 Naphtha (petroleum), chemically neutral- 64742–61–6 Slack wax (petroleum) ized heavy 64742–62–7 Residual oils (petroleum), solvent-dewaxed 64742–23–0 Naphtha (petroleum), chemically neutral- 64742–63–8 Distillates (petroleum), solvent-dewaxed ized light heavy naphthenic 64742–24–1 Sludges (petroleum), acid 64742–64–9 Distillates (petroleum), solvent-dewaxed 64742–25–2 Lubricating oils (petroleum), acid-treated light naphthenic spent 64742–65–0 Distillates (petroleum), solvent-dewaxed 64742–26–3 Hydrocarbon waxes (petroleum), acid-treat- heavy paraffinic ed 64742–67–2 Foots oil (petroleum)

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CAS No. Product CAS No. Product

64742–68–3 Naphthenic oils (petroleum), catalytic 67891–80–9 Distillates (petroleum), light arom. dewaxed heavy 67891–81–0 Distillates (petroleum), oxidized light, potas- 64742–69–4 Naphthenic oils (petroleum), catalytic sium salts dewaxed light 67891–82–1 Hydrocarbon waxes (petroleum), oxidized, 64742–70–7 Paraffin oils (petroleum), catalytic dewaxed compounds with ethanolamine heavy 67891–83–2 Hydrocarbon waxes (petroleum), oxidized, 64742–71–8 Paraffin oils (petroleum), catalytic dewaxed compounds with isopropanolamine light 67891–85–4 Hydrocarbon waxes (petroleum), oxidized, 64742–72–9 Distillates (petroleum), catalytic dewaxed compounds with triisopropanolamine middle 67891–86–5 Hydrocarbon waxes (petroleum), oxidized, 64742–73–0 Naphtha (petroleum), hydrodesulfurized compds. with diisopropanolamine light 68131–05–5 Hydrocarbon oils, process blends 64742–75–2 Naphthenic oils (petroleum), complex 68131–49–7 Aromatic hydrocarbons, C6-10, acid-treat- dewaxed heavy ed, neutralized 64742–76–3 Naphthenic oils (petroleum), complex 68131–75–9 Gases (petroleum), C3-4 dewaxed light 68153–22–0 Paraffin waxes and Hydrocarbon waxes, 64742–78–5 Residues (petroleum), hydrodesulfurized oxidized atmospheric tower 68187–57–5 Pitch, coal tar-petroleum 64742–79–6 Gas oils (petroleum), hydrodesulfurized 68187–58–6 Pitch, petroleum, arom. 64742–80–9 Distillates (petroleum), hydrodesulfurized 68187–60–0 Hydrocarbons, C4, ethane-propane- middle cracked 64742–81–0 Kerosine (petroleum), hydrodesulfurized 64742–82–1 Naphtha (petroleum), hydrodesulfurized 68307–98–2 Tail gas (petroleum), catalytic cracked dis- heavy tillate and catalytic cracked naphtha frac- 64742–83–2 Naphtha (petroleum), light steam-cracked tionation absorber 64742–85–4 Residues (petroleum), hydrodesulfurized 68307–99–3 Tail gas (petroleum), catalytic polymn. vacuum naphtha fractionation stabilizer 64742–86–5 Gas oils (petroleum), hydrodesulfurized 68308–00–9 Tail gas (petroleum), catalytic reformed heavy vacuum naphtha fractionation stabilizer, hydrogen 64742–87–6 Gas oils (petroleum), hydrodesulfurized sulfide-free light vacuum 68308–01–0 Tail gas (petroleum), cracked distillate 64742–88–7 Solvent naphtha (petroleum), medium hydrotreater stripper aliph. 68308–02–1 Tail gas (petroleum), distn., hydrogen sul- 64742–89–8 Solvent naphtha (petroleum), light aliph. fide-free 64742–90–1 Residues (petroleum), steam-cracked 68308–03–2 Tail gas (petroleum), gas oil catalytic crack- 64742–91–2 Distillates (petroleum), steam-cracked ing absorber 64742–92–3 Petroleum resins, oxidized 68308–04–3 Tail gas (petroleum), gas recovery plant 64742–93–4 Asphalt, oxidized 68308–05–4 Tail gas (petroleum), gas recovery plant 64742–94–5 Solvent naphtha (petroleum), heavy arom. deethanizer 64742–95–6 Solvent naphtha (petroleum), light arom. 68308–06–5 Tail gas (petroleum), hydrodesulfurized dis- 64742–96–7 Solvent naphtha (petroleum), heavy aliph. tillate and hydrodesulfurized naphtha 64742–97–8 Distillates (petroleum), oxidized heavy fractionator, acid-free 64742–98–9 Distillates (petroleum), oxidized light 68308–07–6 Tail gas (petroleum), hydrodesulfurized 64742–99–0 Residual oils (petroleum), oxidized vacuum gas oil stripper, hydrogen sul- 64743–00–6 Hydrocarbon waxes (petroleum), oxidized fide-free 64743–01–7 Petrolatum (petroleum), oxidized 68308–08–7 Tail gas (petroleum), isomerized naphtha 64743–02–8 Alkenes, C>10 .alpha.- fractionation stabilizer 64743–03–9 Phenols (petroleum) 68308–09–8 Tail gas (petroleum), light straight-run 64743–04–0 Coke (petroleum), recovery naphtha stabilizer, hydrogen sulfide-free 64743–05–1 Coke (petroleum), calcined 68308–10–1 Tail gas (petroleum), straight-run distillate 64743–06–2 Extracts (petroleum), gas oil solvent hydrodesulfurizer, hydrogen sulfide-free 64743–07–3 Sludges (petroleum), chemically neutralized 68308–11–2 Tail gas (petroleum), propane-propylene 64754–89–8 Naphthenic acids (petroleum), crude alkylation feed prep deethanizer 64771–71–7 Paraffins (petroleum), normal C>10 68308–12–3 Tail gas (petroleum), vacuum gas oil 64771–72–8 Paraffins (petroleum), normal C5-20 hydrodesulfurizer, hydrogen sulfide-free 67254–74–4 Naphthenic oils 68308–27–0 Fuel gases, refinery 67674–12–8 Residual oils (petroleum), oxidized, com- 68333–22–2 Residues (petroleum), atmospheric pounds with triethanolamine 68333–23–3 Naphtha (petroleum), heavy coker 67674–13–9 Petrolatum (petroleum), oxidized, partially 68333–24–4 Hydrocarbon waxes (petroleum), oxidized, deacidified compds. with triethanolamine 67674–15–1 Petrolatum (petroleum), oxidized, Me ester 68333–25–5 Distillates (petroleum), hydrodesulfurized 67674–16–2 Hydrocarbon waxes (petroleum), oxidized, light catalytic cracked partially deacidified 68333–26–6 Clarified oils (petroleum), hydrodesulfurized 67674–17–3 Distillates (petroleum), oxidized light, com- catalytic cracked pounds with triethanolamine 68333–27–7 Distillates (petroleum), hydrodesulfurized 67674–18–4 Distillates (petroleum), oxidized light, Bu intermediate catalytic cracked esters 68333–28–8 Distillates (petroleum), hydrodesulfurized 67891–79–6 Distillates (petroleum), heavy arom. heavy catalytic cracked

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CAS No. Product CAS No. Product

68333–29–9 Residues (petroleum), light naphtha solvent 68476–47–1 Hydrocarbons, C2-6, C6-8 catalytic re- extracts former 68333–30–2 Distillates (petroleum), oxidized heavy ther- 68476–49–3 Hydrocarbons, C2-4, C3-rich mal cracked 68476–50–6 Hydrocarbons, C≥5, C5-6-rich 68333–81–3 Alkanes, C4-12 68476–52–8 Hydrocarbons, C4, ethylene-manuf.-by- 68333–88–0 Aromatic hydrocarbons, C9-17 product 68334–30–5 Fuels, diesel 68476–53–9 Hydrocarbons, C≥20, petroleum wastes 68409–99–4 Gases (petroleum), catalytic cracked 68476–54–0 Hydrocarbons, C3-5, polymn. unit feed overheads 68476–55–1 Hydrocarbons, C5-rich 68410–00–4 Distillates (petroleum), crude oil 68476–56–2 Hydrocarbons, cyclic C5 and C6 68410–05–9 Distillates (petroleum), straight-run light 68476–77–7 Lubricating oils, refined used 68410–12–8 Distillates (petroleum), steam-cracked, C5- 68476–81–3 Paraffin waxes and Hydrocarbon waxes, 10 fraction, high-temp. stripping products oxidized, calcium salts with light steam-cracked petroleum naph- 68476–84–6 Petroleum products, gases, inorg. tha C5 fraction polymers 68476–85–7 Petroleum gases, liquefied 68410–71–9 Raffinates (petroleum), catalytic reformer 68476–86–8 Petroleum gases, liquefied, sweetened ethylene glycol-water countercurrent 68477–25–8 Waste gases, vent gas, C1-6 exts. 68477–26–9 Wastes, petroleum 68410–96–8 Distillates (petroleum), hydrotreated middle, 68477–29–2 Distillates (petroleum), catalytic reformer intermediate boiling fractionator residue, high-boiling 68410–97–9 Distillates (petroleum), light distillate 68477–30–5 Distillates (petroleum), catalytic reformer hydrotreating process, low-boiling fractionator residue, intermediate-boiling 68410–98–0 Distillates (petroleum), hydrotreated heavy 68477–31–6 Distillates (petroleum), catalytic reformer naphtha, deisohexanizer overheads fractionator residue, low-boiling 68411–00–7 Alkenes, C>8 68477–33–8 Gases (petroleum), C3-4, isobutane-rich 68425–29–6 Distillates (petroleum), naphtha-raffinate 68477–34–9 Distillates (petroleum), C3-5, 2-methyl-2- pyrolyzate-derived, gasoline-blending butene-rich 68425–33–2 Petrolatum (petroleum), oxidized, barium 68477–35–0 Distillates (petroleum), C3-6, piperylene- salt rich 68425–34–3 Petrolatum (petroleum), oxidized, calcium 68477–36–1 Distillates (petroleum), cracked steam- salt cracked, C5-18 fraction 68425–35–4 Raffinates (petroleum), reformer, Lurgi unit- 68477–38–3 Distillates (petroleum), cracked steam- sepd. cracked petroleum distillates 68425–39–8 Alkenes, C>10 .alpha.-, oxidized 68477–39–4 Distillates (petroleum), cracked stripped 68441–09–8 Hydrocarbon waxes (petroleum), clay-treat- steam-cracked petroleum distillates, C8- ed microcryst., contg. polyethylene, 10 fraction oxidized 68477–40–7 Distillates (petroleum), cracked stripped 68459–78–9 Alkenes, C18-24 .alpha.-, dimers steam-cracked petroleum distillates, C10- 68475–57–0 Alkanes, C1-2 12 fraction 68475–58–1 Alkanes, C2-3 68477–41–8 Gases (petroleum), extractive, C3-5, buta- 68475–59–2 Alkanes, C3-4 diene-butene-rich 68475–60–5 Alkanes, C4-5 68477–42–9 Gases (petroleum), extractive, C3-5, 68475–61–6 Alkenes, C5, naphtha-raffinate pyrolyzate- butene-isobutylene-rich derived 68477–44–1 Distillates (petroleum), heavy naphthenic, 68475–70–7 Aromatic hydrocarbons, C6-8, naphtha-raf- mixed with steam-cracked petroleum dis- finate pyrolyzate-derived tillates C5-12 fraction 68475–79–6 Distillates (petroleum), catalytic reformed 68477–47–4 Distillates (petroleum), mixed heavy olefin depentanizer 68475–80–9 Distillates (petroleum), light steam-cracked vacuum, heart-cut naphtha 68477–48–5 Distillates (petroleum), mixed heavy olefin 68476–26–6 Fuel gases vacuum, low-boiling 68476–27–7 Fuel gases, amine system residues 68477–53–2 Distillates (petroleum), steam-cracked, C5- 68476–28–8 Fuel gases, C6-8 catalytic reformer 12 fraction 68476–29–9 Fuel gases, crude oil distillates 68477–54–3 Distillates (petroleum), steam-cracked, C8- 68476–30–2 Fuel oil, no. 2 12 fraction 68476–31–3 Fuel oil, no. 4 68477–55–4 Distillates (petroleum), steam-cracked, C5- 68476–32–4 Fuel oil, residues-straight-run gas oils, 10 fraction, mixed with light steam- high-sulfur cracked petroleum naphtha C5 fraction 68476–33–5 Fuel oil, residual 68477–58–7 Distillates (petroleum), steam-cracked pe- 68476–34–6 Fuels, diesel, no. 2 troleum distillates, C5-18 fraction 68476–39–1 Hydrocarbons, aliph.-arom.-C4-5-olefinic 68477–59–8 Distillates (petroleum), steam-cracked pe- 68476–40–4 Hydrocarbons, C3-4 troleum distillates cyclopentadiene conc. 68476–42–6 Hydrocarbons, C4-5 68477–60–1 Extracts (petroleum), cold-acid 68476–43–7 Hydrocarbons, C4-6, C5-rich 68477–61–2 Extracts (petroleum), cold-acid, C4-6 68476–44–8 Hydrocarbons, C>3 68477–62–3 Extracts (petroleum), cold-acid, C3-5, 68476–45–9 Hydrocarbons, C5-10 arom. conc., ethyl- butene-rich ene-manuf.-by-product 68477–63–4 Extracts (petroleum), reformer recycle 68476–46–0 Hydrocarbons, C3-11, catalytic cracker dis- 68477–64–5 Gases (petroleum), acetylene manuf. off tillates 68477–65–6 Gases (petroleum), amine system feed

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CAS No. Product CAS No. Product

68477–66–7 Gases (petroleum), benzene unit 68478–05–7 Gases (petroleum), thermal cracking distn. hydrodesulfurizer off 68478–08–0 Naphtha (petroleum), light steam-cracked, 68477–67–8 Gases (petroleum), benzene unit recycle, C5-fraction, oligomer conc. hydrogen-rich 68478–10–4 Naphtha (petroleum), light steam-cracked, 68477–68–9 Gases (petroleum), blend oil, hydrogen-ni- debenzenized, C8-16-cycloalkadiene trogen-rich conc. 68477–69–0 Gases (petroleum), butane splitter 68478–12–6 Residues (petroleum), butane splitter bot- overheads toms 68477–70–3 Gases (petroleum), C2-3 68478–13–7 Residues (petroleum), catalytic reformer 68477–71–4 Gases (petroleum), catalytic-cracked gas fractionator residue distn. oil depropanizer bottoms, C4-rich acid- 68478–15–9 Residues (petroleum), C6-8 catalytic re- free former 68477–72–5 Gases (petroleum), catalytic-cracked naph- 68478–16–0 Residual oils (petroleum), deisobutanizer tha debutanizer bottoms, C3-5-rich tower 68477–73–6 Gases (petroleum), catalytic cracked naph- 68478–17–1 Residues (petroleum), heavy coker gas oil tha depropanizer overhead, C3-rich acid- and vacuum gas oil free 68478–18–2 Residues (petroleum), heavy olefin vacuum 68477–74–7 Gases (petroleum), catalytic cracker 68478–19–3 Residual oils (petroleum), propene purifn. 68477–75–8 Gases (petroleum), catalytic cracker, C1-5- splitter rich 68478–20–6 Residues (petroleum), steam-cracked pe- 68477–76–9 Gases (petroleum), catalytic polymd. naph- troleum distillates cyclopentadiene conc., tha stabilizer overhead, C2-4-rich C4-cyclopentadiene-free 68477–77–0 Gases (petroleum), catalytic reformed 68478–22–8 Tail gas (petroleum), catalytic cracked naphtha stripper overheads naphtha stabilization absorber 68477–79–2 Gases (petroleum), catalytic reformer, C1- 68478–24–0 Tail gas (petroleum), catalytic cracker, 4-rich 68477–80–5 Gases (petroleum), C6-8 catalytic reformer catalytic reformer and hydrodesulfurizer recycle combined fractionater 68477–81–6 Gases (petroleum), C6-8 catalytic reformer 68478–25–1 Tail gas (petroleum), catalytic cracker re- 68477–82–7 Gases (petroleum), C6-8 catalytic reformer fractionation absorber recycle, hydrogen-rich 68478–26–2 Tail gas (petroleum), catalytic reformed 68477–83–8 Gases (petroleum), C3-5 olefinic-paraffinic naphtha fractionation stabilizer alkylation feed 68478–27–3 Tail gas (petroleum), catalytic reformed 68477–84–9 Gases (petroleum), C2-return stream naphtha separator 68477–85–0 Gases (petroleum), C4-rich 68478–28–4 Tail gas (petroleum), catalytic reformed 68477–86–1 Gases (petroleum), deethanizer overheads naphtha stabilizer 68477–87–2 Gases (petroleum), deisobutanizer tower 68478–29–5 Tail gas (petroleum), cracked distillate overheads hydrotreater separator 68477–88–3 Gases (petroleum), deethanizer overheads, 68478–30–8 Tail gas (petroleum), hydrodesulfurized C3-rich straight-run naphtha separator 68477–89–4 Distillates (petroleum), depentanizer 68478–31–9 Tail gas (petroleum), isomerized naphtha overheads fractionates, hydrogen sulfide-free 68477–90–7 Gases (petroleum), depropanizer dry, 68478–32–0 Tail gas (petroleum), saturate gas plant propene-rich mixed stream, C4-rich 68477–91–8 Gases (petroleum), depropanizer 68478–33–1 Tail gas (petroleum), saturate gas recovery overheads plant, C1-2-rich 68477–92–9 Gases (petroleum), dry sour, gas-concn.- 68478–34–2 Tail gas (petroleum), vacuum residues unit-off thermal cracker 68477–93–0 Gases (petroleum), gas concn. reabsorber 68512–61–8 Residues (petroleum), heavy coker and distn. light vacuum 68477–94–1 Gases (petroleum), gas recovery plant 68512–62–9 Residues (petroleum), light vacuum depropanizer overheads 68512–78–7 Solvent naphtha (petroleum), light arom., 68477–95–2 Gases (petroleum), Girbatol unit feed hydrotreated 68477–96–3 Gases (petroleum), hydrogen absorber off 68512–91–4 Hydrocarbons, C3-4-rich, petroleum dis- 68477–97–4 Gases (petroleum), hydrogen-rich tillates 68477–98–5 Gases (petroleum), hydrotreater blend oil 68513–02–0 Naphtha (petroleum), full-range coker recycle, hydrogen-nitrogen rich 68513–03–1 Naphtha (petroleum), light catalytic re- 68477–99–6 Gases (petroleum), isomerized naphtha formed, arom.-free fractionater, C4-rich, hydrogen sulfide- 68513–11–1 Fuel gases, hydrotreater fractionation, free scrubbed 68478–00–2 Gases (petroleum), recycle, hydrogen-rich 68513–12–2 Fuel gases, saturate gas unit fractionater- 68478–01–3 Gases (petroleum), reformer make-up, hy- absorber overheads drogen-rich 68513–13–3 Fuel gases, thermal cracked catalytic 68478–02–4 Gases (petroleum), reforming hydrotreater cracking residue 68478–03–5 Gases (petroleum), reforming hydrotreater, 68513–14–4 Gases (petroleum), catalytic reformed hydrogen-methane-rich straight-run naphtha stabilizer overheads 68478–04–6 Gases (petroleum), reforming hydrotreater 68513–15–5 Gases (petroleum), full-range straight-run make-up, hydrogen-rich naphtha dehexanizer off

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CAS No. Product CAS No. Product

68513–16–6 Gases (petroleum), hydrocracking 68527–11–7 Alkenes, C5 depropanizer off, hydrocarbon-rich 68527–13–9 Gases (petroleum), acid, ethanolamine 68513–17–7 Gases (petroleum), light straight-run naph- scrubber tha stabilizer off 68527–14–0 Gases (petroleum), methane-rich off 68513–18–8 Gases (petroleum), reformer effluent high- 68527–15–1 Gases (petroleum), oil refinery gas distn. pressure flash drum off off 68513–19–9 Gases (petroleum), reformer effluent low- 68527–16–2 Hydrocarbons, C1-3 pressure flash drum off 68527–18–4 Gas oils (petroleum), steam-cracked 68513–62–2 Disulfides, C5-12-alkyl 68527–19–5 Hydrocarbons, C1-4, debutanizer fraction 68513–63–3 Distillates (petroleum), catalytic reformed 68527–21–9 Naphtha (petroleum), clay-treated full-range straight-run naphtha overheads straight-run 68513–65–5 Butane, branched and linear 68527–22–0 Naphtha (petroleum), clay-treated light 68513–66–6 Residues (petroleum), alkylation splitter, straight-run C4-rich 68527–23–1 Naphtha (petroleum), light steam-cracked 68513–67–7 Residues (petroleum), cyclooctadiene bot- arom. toms 68527–26–4 Naphtha (petroleum), light steam-cracked, 68513–68–8 Residues (petroleum), deethanizer tower debenzenized 68513–69–9 Residues (petroleum), steam-cracked light 68527–27–5 Naphtha (petroleum), full-range alkylate, 68513–74–6 Waste gases, ethylene oxide absorber-re- butane-contg. actor 68553–00–4 Fuel oil, no. 6 68514–15–8 Gasoline, vapor-recovery 68514–29–4 Hydrocarbons, amylene feed debutanizer 68553–14–0 Hydrocarbons, C8-11 overheads nonextractable raffinates 68602–79–9 Distillates (petroleum), benzene unit 68514–31–8 Hydrocarbons, C1-4 hydrotreater dipentanizer overheads 68514–32–9 Hydrocarbons, C10 and C12, olefin-rich 68602–81–3 Distillates, hydrocarbon resin prodn. higher 68514–33–0 Hydrocarbons, C12 and C14, olefin-rich boiling 68514–34–1 Hydrocarbons, C9-14, ethylene-manuf.-by- 68602–82–4 Gases (petroleum), benzene unit product hydrotreater depentenizer overheads 68514–35–2 Hydrocarbons, C14-30, olefin-rich 68602–83–5 Gases (petroleum), C1-5, wet 68514–36–3 Hydrocarbons, C1-4, sweetened 68602–84–6 Gases (petroleum), secondary absorber off, 68514–37–4 Hydrocarbons, C4-5-unsatd. fluidized catalytic cracker overheads 68514–38–5 Hydrocarbons, C4-10-unsatd. fractionater 68514–39–6 Naphtha (petroleum), light steam-cracked, 68602–96–0 Distillates (petroleum), oxidized light, strong isoprene-rich acid components, compds. with 68514–79–4 Petroleum products, hydrofiner- diethanolamine powerformer reformates 68602–97–1 Distillates (petroleum), oxidized light, strong 68515–25–3 Benzene, C1-9-alkyl derivs. acid components, sodium salts 68515–26–4 Benzene, di-C12-14-alkyl derivs. 68602–98–2 Distillates (petroleum), oxidized light, strong 68515–27–5 Benzene, di-C10-14-alkyl derivs., fraction- acid components ation overheads, heavy ends 68602–99–3 Distillates (petroleum), oxidized light, strong 68515–28–6 Benzene, di-C10-14-alkyl derivs., fraction- acid-free ation overheads, light ends 68603–00–9 Distillates (petroleum), thermal cracked 68515–29–7 Benzene, di-C10-14-alkyl derivs., fraction- naphtha and gas oil ation overheads, middle cut 68603–01–0 Distillates (petroleum), thermal cracked 68515–30–0 Benzene, mono-C20-48-alkyl derivs. naphtha and gas oil, C5-dimer-contg. 68515–32–2 Benzene, mono-C12-14-alkyl derivs., frac- 68603–02–1 Distillates (petroleum), thermal cracked tionation bottoms naphtha and gas oil, dimerized 68515–33–3 Benzene, mono-C10-12-alkyl derivs., frac- 68603–03–2 Distillates (petroleum), thermal cracked tionation bottoms, heavy ends naphtha and gas oil, extractive 68515–34–4 Benzene, mono-C12-14-alkyl derivs., frac- 68603–08–7 Naphtha (petroleum), arom.-contg. tionation bottoms, heavy ends 68603–09–8 Hydrocarbon waxes (petroleum), oxidized, 68515–35–5 Benzene, mono-C10-12-alkyl derivs., frac- calcium salts tionation bottoms, light ends 68603–10–1 Hydrocarbon waxes (petroleum), oxidized, 68515–36–6 Benzene, mono-C12-14-alkyl derivs., frac- Me esters, barium salts tionation bottoms, light ends 68603–11–2 Hydrocarbon waxes (petroleum), oxidized, 68516–20–1 Naphtha (petroleum), steam-cracked mid- Me esters, calcium salts dle arom. 68603–12–3 Hydrocarbon waxes (petroleum), oxidized, 68526–52–3 Alkenes, C6 Me esters, sodium salts 68526–53–4 Alkenes, C6-8, C7-rich 68603–13–4 Petrolatum (petroleum), oxidized, ester with 68526–54–5 Alkenes, C7-9, C8-rich sorbitol 68526–55–6 Alkenes, C8-10, C9-rich 68603–14–5 Residual oils (petroleum), oxidized, calcium 68526–56–7 Alkenes, C9-11, C10-rich salts 68526–57–8 Alkenes, C10-12, C11-rich 68603–31–6 Alkenes, C10, tert-amylene concentrator 68526–58–9 Alkenes, C11-13, C12-rich by-product 68526–77–2 Aromatic hydrocarbons, ethane cracking 68603–32–7 Alkenes, C15-20 .alpha.-, isomerized scrubber effluent and flare drum 68606–09–7 Fuel gases, expander off 68526–99–8 Alkenes, C6-9 .alpha.- 68606–10–0 Gasoline, pyrolysis, debutanizer bottoms 68527–00–4 Alkenes, C8-9 .alpha.- 68606–11–1 Gasoline, straight-run, topping-plant

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CAS No. Product CAS No. Product

68606–24–6 Hydrocarbons, C4, butene concentrator by- 68855–60–7 Alkenes, C14-20 .alpha.- product 68911–58–0 Gases (petroleum), hydrotreated sour ker- 68606–25–7 Hydrocarbons, C2-4 osine depentanizer stabilizer off 68606–26–8 Hydrocarbons, C3 68911–59–1 Gases (petroleum), hydrotreated sour ker- 68606–27–9 Gases (petroleum), alkylation feed osine flash drum 68606–28–0 Hydrocarbons, C5 and C10-aliph. and C6- 68915–96–8 Distillates (petroleum), heavy straight-run 8-arom. 68915–97–9 Gas oils (petroleum), straight-run, high-boil- 68606–31–5 Hydrocarbons, C3-5, butadiene purifn. by- ing product 68918–69–4 Petrolatum (petroleum), oxidized, zinc salt 68606–34–8 Gases (petroleum), depropanizer bottoms 68918–73–0 Residues (petroleum), clay-treating filter fractionation off wash 68606–36–0 Hydrocarbons, C5-unsatd. rich, isoprene 68918–93–4 Paraffin waxes and Hydrocarbon waxes, purifn. by-product 68607–11–4 Petroleum products, refinery gases oxidized, alkali metal salts 68607–30–7 Residues (petroleum), topping plant, low- 68918–98–9 Fuel gases, refinery, hydrogen sulfide-free sulfur 68918–99–0 Gases (petroleum), crude oil fractionation 68608–56–0 Waste gases, from carbon black manuf. off 68647-60–9 Hydrocarbons, C>4 68919–00–6 Gases (petroleum), dehexanizer off 68647–61–0 Hydrocarbons, C4-5, tert-amylene concen- 68919–01–7 Gases (petroleum), distillate unifiner trator by-product desulfurization stripper off 68647–62–1 Hydrocarbons, C4-5, butene concentrator 68919–02–8 Gases (petroleum), fluidized catalytic by-product, sour cracker fractionation off 68650–36–2 Aromatic hydrocarbons, C8, o-xylene-lean 68919–03–9 Gases (petroleum), fluidized catalytic 68650–37–3 Paraffin waxes (petroleum), oxidized, so- cracker scrubbing secondary absorber dium salts off 68782–97–8 Distillates (petroleum), hydrofined lubri- 68919–04–0 Gases (petroleum), heavy distillate cating-oil hydrotreater desulfurization stripper off 68782–98–9 Extracts (petroleum), clarified oil solvent, 68919–05–1 Gases (petroleum), light straight run gaso- condensed-ring-arom.-contg. line fractionation stabilizer off 68782–99–0 Extracts (petroleum), heavy clarified oil sol- 68919–06–2 Gases (petroleum), naphtha unifiner vent, condensed-ring-arom.-contg. desulfurization stripper off 68783–00–6 Extracts (petroleum), heavy naphthenic dis- 68919–07–3 Gases (petroleum), platformer stabilizer off, tillate solvent, arom. conc. light ends fractionation 68783–01–7 Extracts (petroleum), heavy naphthenic dis- 68919–08–4 Gases (petroleum), preflash tower off, tillate solvent, paraffinic conc. crude distn. 68783–02–8 Extracts (petroleum), intermediate clarified 68919–09–5 Gases (petroleum), straight-run naphtha oil solvent, condensed-ring-arom.-contg. catalytic reforming off 68783–04–0 Extracts (petroleum), solvent-refined heavy 68919–10–8 Gases (petroleum), straight-run stabilizer paraffinic distillate solvent off 68783–05–1 Gases (petroleum), ammonia-hydrogen sul- 68919–11–9 Gases (petroleum), tar stripper off fide, water-satd. 68919–12–0 Gases (petroleum), unifiner stripper off 68783–06–2 Gases (petroleum), hydrocracking low- 68919–15–3 Hydrocarbons, C6-12, benzene-recovery pressure separator 68919–16–4 Hydrocarbons, catalytic alkylation, by-prod- 68783–07–3 Gases (petroleum), refinery blend ucts, C3-6 68783–08–4 Gas oils (petroleum), heavy atmospheric 68919–17–5 Hydrocarbons, C12-20, catalytic alkylation 68783–09–5 Naphtha (petroleum), catalytic cracked light by-products distd. 68919–19–7 Gases (petroleum), fluidized catalytic 68783–12–0 Naphtha (petroleum), unsweetened cracker splitter residues 68783–13–1 Residues (petroleum), coker scrubber, con- 68919–20–0 Gases (petroleum), fluidized catalytic densed-ring-arom.-contg. 68783–15–3 Alkenes, C6-7 .alpha.- cracker splitter overheads 68783–61–9 Fuel gases, refinery, sweetened 68919–37–9 Naphtha (petroleum), full-range reformed 68783–62–0 Fuel gases, refinery, unsweetened 68920–06–9 Hydrocarbons, C7-9 68783–64–2 Gases (petroleum), catalytic cracking 68920–07–0 Hydrocarbons, C<10-linear 68783–65–3 Gases (petroleum), C2-4, sweetened 68920–64–9 Disulfides, di-C1-2-alkyl 68783–66–4 Naphtha (petroleum), light, sweetened 68921–07–3 Distillates (petroleum), hydrotreated light 68814–47–1 Waste gases, refinery vent catalytic cracked 68814–67–5 Gases (petroleum), refinery 68921–08–4 Distillates (petroleum), light straight-run 68814–87–9 Distillates (petroleum), full-range straight- gasoline fractionation stabilizer run middle overheads 68814–89–1 Extracts (petroleum), heavy paraffinic dis- 68921–09–5 Distillates (petroleum), naphtha unifiner tillates, solvent-deasphalted stripper 68814–90–4 Gases (petroleum), platformer products 68921–67–5 Hydrocarbons, ethylene-manuf.-by-product separator off distn. residues 68814–91–5 Alkenes, C5-9 .alpha.- 68952–76–1 Gases (petroleum), catalytic cracked naph- 68855–57–2 Alkenes, C6-12 .alpha.- tha debutanizer 68855–58–3 Alkenes, C10-16 .alpha.- 68952–77–2 Tail gas (petroleum), catalytic cracked dis- 68855–59–4 Alkenes, C14-18 .alpha.- tillate and naphtha stabilizer

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CAS No. Product CAS No. Product

68952–78–3 Tail gas (petroleum), catalytic 70592–79–9 Residues (petroleum), atm. tower, light hydrodesulfurized distillate fractionation 70693–00–4 Hydrocarbon waxes (petroleum), oxidized, stabilizer, hydrogen sulfide-free sodium salts 68952–79–4 Tail gas (petroleum), catalytic 70693–06–0 Aromatic hydrocarbons, C9-11 hydrodesulfurized naphtha separator 70913–85–8 Residues (petroleum), solvent-extd. vacu- 68952–80–7 Tail gas (petroleum), straight-run naphtha um distilled atm. residuum hydrodesulfurizer 70913–86–9 Alkanes, C18-70 68952–81–8 Tail gas (petroleum), thermal-cracked dis- 70955–08–7 Alkanes, C4-6 tillate, gas oil and naphtha absorber 70955–09–8 Alkenes, C13-14 .alpha.- 68952–82–9 Tail gas (petroleum), thermal cracked hy- 70955–10–1 Alkenes, C15-18 .alpha.- drocarbon fractionation stabilizer, petro- 70955–17–8 Aromatic hydrocarbons, C12-20 leum coking 71243–66–8 Hydrocarbon waxes (petroleum), clay-treat- 68953–80–0 Benzene, mixed with toluene, dealkylation ed, microcryst., oxidized, potassium salts product 71302–82–4 Hydrocarbons, C5-8, Houdry butadiene 68955–27–1 Distillates (petroleum), petroleum residues manuf. by-product vacuum 71329–37–8 Residues (petroleum), catalytic cracking 68955–28–2 Gases (petroleum), light steam-cracked, depropanizer, C4-rich butadiene conc. 71808–30–5 Tail gas (petroleum), thermal cracking ab- 68955–31–7 Gases (petroleum), butadiene process, sorber inorg. 72230–71–8 Distillates (petroleum), cracked steam- 68955–32–8 Natural gas, substitute, steam-reformed cracked, C5-17 fraction desulfurized naphtha 68955–33–9 Gases (petroleum), sponge absorber off, 72623–83–7 Lubricating oils (petroleum), C>25, fluidized catalytic cracker and gas oil hydrotreated bright stock-based desulfurizer overhead fractionation 72623–84–8 Lubricating oils (petroleum), C15-30, 68955–34–0 Gases (petroleum), straight-run naphtha hydrotreated neutral oil-based, contg. catalytic reformer stabilizer overhead solvent deasphalted residual oil 68955–35–1 Naphtha (petroleum), catalytic reformed 72623–85–9 Lubricating oils (petroleum), C20-50, 68955–36–2 Residues (petroleum), steam-cracked, res- hydrotreated neutral oil-based, high-vis- inous cosity 68955–76–0 Aromatic hydrocarbons, C9-16, biphenyl 72623–86–0 Lubricating oils (petroleum), C15-30, deriv.-rich hydrotreated neutral oil-based 68955–96–4 Disulfides, dialkyl and di-Ph, naphtha 72623–87–1 Lubricating oils (petroleum), C20-50, sweetening hydrotreated neutral oil-based 68956–47–8 Fuel oil, isoprene reject absorption 73138–65–5 Hydrocarbon waxes (petroleum), oxidized, 68956–48–9 Fuel oil, residual, wastewater skimmings magnesium salts 68956–52–5 Hydrocarbons, C4-8 92045–43–7 Lubricating oils (petroleum), hydrocracked 68956–54–7 Hydrocarbons, C4-unsatd. nonarom. solvent deparaffined 68956–55–8 Hydrocarbons, C5-unsatd. 92045–58–4 Naphtha (petroleum), isomerization, C6- 68956–70–7 Petroleum products, C5-12, reclaimed, fraction wastewater treatment 92062–09–4 Slack wax (petroleum), hydrotreated 68988–79–4 Benzene, C10-12-alkyl derivs., distn. resi- 93762–80–2 Alkenes, C15-18 dues 98859–55–3 Distillates (petroleum), oxidized heavy, 68988–99–8 Phenols, sodium salts, mixed with sulfur compds. with diethanolamine compounds, gasoline alk. scrubber resi- 98859–56–4 Distillates (petroleum), oxidized heavy, so- dues dium salts 68989–88–8 Gases (petroleum), crude distn. and cata- 101316–73–8 Lubricating oils (petroleum), used, non- lytic cracking catalytically refined 68990–35–2 Distillates (petroleum), arom., hydrotreated, 164907–78–2 Extracts (petroleum), asphaltene-low vacu- dicyclopentadiene-rich um residue solvent 68991–49–1 Alkanes, C10-13, arom.-free desulfurized 164907–79–3 Residues (petroleum), vacuum, asphaltene- 68991–50–4 Alkanes, C14-17, arom.-free desulfurized low 68991–51–5 Alkanes, C10-13, desulfurized 178603–63–9 Gas oils (petroleum), vacuum, 68991–52–6 Alkenes, C10-16 hydrocracked, hydroisomerized, hydro- 69013–21–4 Fuel oil, pyrolysis genated, C10-25 69029–75–0 Oils, reclaimed 178603–64–0 Gas oils (petroleum), vacuum, 69430–33–7 Hydrocarbons, C6-30 hydrocracked, hydroisomerized, hydro- 70024–88–3 Ethene, thermal cracking products genated, C15-30, branched and cyclic 70528–71–1 Distillates (petroleum), heavy distillate sol- 178603–65–1 Gas oils (petroleum), vacuum, vent ext. heart-cut hydrocracked, hydroisomerized, hydro- 70528–72–2 Distillates (petroleum), heavy distillate sol- genated, C20-40, branched and cyclic vent ext. vacuum overheads 178603–66–2 Gas oils (petroleum), vacuum, 70528–73–3 Residues (petroleum), heavy distillate sol- hydrocracked, hydroisomerized, hydro- vent ext. vacuum genated, C25-55, branched and cyclic 70592–76–6 Distillates (petroleum), intermediate vacu- 212210–93–0 Solvent naphtha (petroleum), heavy arom., um distn. residues 70592–77–7 Distillates (petroleum), light vacuum 221120–39–4 Distillates (petroleum), cracked steam- 70592–78–8 Distillates (petroleum), vacuum cracked, C5-12 fraction

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CAS NUMBERS OF PARTIALLY EXEMPT CHEM- chemical in question, as well as its ICAL SUBSTANCES TERMED ‘‘PETROLEUM CAS number or other chemical identi- PROCESS STREAMS’’ FOR PURPOSES OF IN- fication number as identified in VENTORY UPDATE REPORTING—Continued § 710.52(c)(3)(i), and must contain a written rationale for the request that CAS No. Product provides sufficient specific informa- 445411–73–4 Gas oils (petroleum), vacuum, tion, addressing the considerations hydrocracked, hydroisomerized, hydro- listed in § 710.46(b)(2)(ii), including cites genated, C10-25, branched and cyclic and relevant documents, to demonstrate to EPA that the collection of (2) Specific exempted chemical sub- the information in § 710.52(c)(4) for the stances—(i) Exemption. EPA has deter- chemical in question either is or is not mined that, at this time, the informa- of low current interest. If a request re- tion in § 710.52(c)(4) associated with the lated to a particular chemical is resub- chemicals listed in paragraph (b)(2)(iv) mitted, any subsequent request must of this section is of low current inter- clearly identify new information con- est. tained in the request. EPA may request (ii) Considerations. In making its de- other information that it believes nec- termination of whether this partial ex- essary to evaluate the request. EPA emption should apply to a particular will issue a written response to each chemical substance, EPA will consider request within 120 days of receipt of the totality of information available the request, and will maintain copies of for the chemical substance in question, these responses in a public docket that including but not limited to, one or will be established for each reporting more of the following considerations: cycle. (A) Whether the chemical qualifies or (B) As needed, the Agency will ini- has qualified in past IUR collections tiate rulemaking to make revisions to for the reporting of the information de- the list in paragraph (b)(2)(iv) of this scribed in § 710.52(c)(4) (i.e., at least one site manufactures 300,000 pounds or section. (C) To assist EPA in reaching a deci- more of the chemical). (B) The chemical substance’s chem- sion regarding a particular request ical and physical properties or poten- prior to a given reporting year, re- tial for persistence, bioaccumulation, quests must be submitted to EPA no health effects, or environmental effects later than 12 months prior to the start (considered independently or together). of the reporting year, i.e., by January (C) The information needs of EPA, 1, 2004, or by each January 1 at 5–year other federal agencies, tribes, states, intervals thereafter. and local governments, as well as (iv) List of chemical substances. EPA members of the public. has designated the following chemical (D) The availability of other com- substances, listed by CAS Number, as plementary risk screening information. partially exempt from reporting under (E) The availability of comparable the IUR. processing and use information. CAS NUMBERS OF PARTIALLY EXEMPT (F) Whether the potential risks of the chemical substance are adequately CHEMICAL SUBSTANCES UNDER § 710.46(b)(2) managed. CAS No. Chemical (iii) Amendments. EPA may amend 50–70–4 D-Glucitol the chemical list in paragraph (b)(2)(iv) 50–81–7 L-Ascorbic acid of this section on its own initiative or 50–99–7 D-Glucose in response to a request from the pub- 56–81–5 1,2,3-Propanetriol 56–87–1 L-Lysine lic based on EPA’s determination of 57–50–1 .alpha.-D-Glucopyranoside, .beta.-D- whether the information in § 710.52(c)(4) fructofuranosyl is of low interest. 58–95–7 2H-1-Benzopyran-6-ol, 3,4-dihydro-2,5,7,8- (A) Any person may request that tetramethyl-2-[(4R,8R)-4,8,12- trimethyltridecyl]-, acetate, (2R)- EPA amend the chemical list in para- 59–02–9 2H-1-Benzopyran-6-ol, 3,4-dihydro-2,5,7,8- graph (b)(2)(iv) of this section. Your re- tetramethyl-2-[(4R,8R)-4,8,12- quest must be in writing and must be trimethyltridecyl]-, (2R)- 59–51–8 Methionine submitted to the address provided in 69–65–8 D-Mannitol § 710.59(d). Requests must identify the 87–79–6 L-Sorbose

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CAS NUMBERS OF PARTIALLY EXEMPT CHEM- CAS NUMBERS OF PARTIALLY EXEMPT CHEM- ICAL SUBSTANCES UNDER § 710.46(b)(2)— ICAL SUBSTANCES UNDER § 710.46(b)(2)— Continued Continued

CAS No. Chemical CAS No. Chemical

87–99–0 Xylitol 68424–61–3 Glycerides, C16-18 and C18-unsatd. mono- 96–10–6 Aluminum, chlorodiethyl- and di- 97–93–8 Aluminum, triethyl- 68425–17–2 Syrups, hydrolyzed starch, hydrogenated 100–99–2 Aluminum, tris(2-methylpropyl)- 68439–86–1 Bone, ash 123–94–4 Octadecanoic acid, 2,3-dihydroxypropyl 68442–69–3 Benzene, mono-C10-14-alkyl derivs. ester 68476–78–8 Molasses 124–38–9 Carbon dioxide 68514–27–2 Grease, catch basin 137–08–6 .beta.-Alanine, N-[(2R)-2,4-dihydroxy-3,3-di- 68514–74–9 Palm oil, hydrogenated methyl-1-oxobutyl]-, calcium alt (2:1) 68525–87–1 Corn oil, hydrogenated 142–47–2 L-Glutamic acid, monosodium salt 68648–87–3 Benzene, C10-16-alkyl derivs. 150–30–1 Phenylalanine 68918–42–3 Soaps, stocks, soya 563–43–9 Aluminum, dichloroethyl- 1070–00–4 Aluminum, trioctyl- 68952–94–3 Soaps, stocks, vegetable-oil 1116–70–7 Aluminum, tributyl- 68956–68–3 Fats and glyceridic oils, vegetable 1116–73–0 Aluminum, trihexyl- 68989–98–0 Fats and glyceridic oils, vegetable, resi- 1191–15–7 Aluminum, hydrobis(2-methylpropyl)- dues 1317–65–3 Limestone 73138–67–7 Lard, hydrogenated 1333–74–0 Hydrogen 120962–03–0 Canola oil 1592–23–0 Octadecanoic acid, calcium salt 129813–58–7 Benzene, mono-C10-13-alkyl derivs. 7440–37–1 Argon 129813–59–8 Benzene, mono-C12-14-alkyl derivs. 7440–44–0 Carbon 129813–60–1 Benzene, mono-C14-16-alkyl derivs. 7727–37–9 Nitrogen 7782–42–5 Graphite (3) Inorganic chemical substances. For 7782–44–7 Oxygen 8001–21–6 Sunflower oil purposes of this subpart, an inorganic 8001–22–7 Soybean oil chemical substance is any chemical 8001–23–8 Safflower oil substance which does not contain car- 8001–26–1 Linseed oil 8001–29–4 Cottonseed oil bon or contains carbon only in the 8001–30–7 Corn oil form of carbonato [=CO3], cyano [--CN], 8001–31–8 Coconut oil cyanato [--OCN], isocyano [--NC], or 8001–78–3 Castor oil, hydrogenated isocyanato [--NCO] groups or the 8001–79–4 Castor oil 8002–03–7 Peanut oil chalcogen analogues of such groups. 8002–13–9 Rape oil During the 2006 submission period, 8002–43–5 Lecithins manufacturers are excluded only from 8002–75–3 Palm oil 8006–54–0 Lanolin the reporting requirements under 8016–28–2 Lard, oil § 710.52(c)(4) for inorganic chemical sub- 8016–70–4 Soybean oil, hydrogenated stances. During the 2006 submission pe- 8021–99–6 Charcoal, bone riod, manufacturers of inorganic chem- 8029–43–4 Syrups, hydrolyzed starch 9004–53–9 Dextrin ical substances are not excluded from 9005–25–8 Starch the other reporting requirements under 9050–36–6 Maltodextrin this part. During submission periods 11103–57–4 Vitamin A 12075–68–2 Aluminum, di-.mu.-chlorochlorotriethyldi- following the 2006 submission period, 12542–85–7 Aluminum, trichlorotrimethyldi- manufacturers of inorganic chemical 16291–96–6 Charcoal substances are subject to all of the re- 26836–47–5 D-Glucitol, monooctadecanoate porting requirements in this subpart. 61789–44–4 Fatty acids, castor-oil 61789–97–7 Tallow [68 FR 890, Jan. 7, 2003, as amended at 69 FR 61789–99–9 Lard 64147–40–6 Castor oil, dehydrated 40791, July 7, 2004; 70 FR 60221, Oct. 17, 2005; 64755–01–7 Fatty acids, tallow, calcium salts 70 FR 74700, Dec. 16, 2005; 70 FR 75068, Dec. 19, 65996–63–6 Starch, acid-hydrolyzed 2005; 71 FR 8470, Feb. 17, 2006] 65996–64–7 Starch, enzyme-hydrolyzed 67701–01–3 Fatty acids, C12-18 § 710.48 Persons who must report. 68002–85–7 Fatty acids, C14-22 and C16-22-unsatd. 68131–37–3 Syrups, hydrolyzed starch, dehydrated Except as provided in §§ 710.49 and 68188–81–8 Grease, poultry 710.50, the following persons are subject 68308–36–1 Soybean meal to the requirements of this subpart. 68308–54–3 Glycerides, tallow mono-, di- and tri-, hydrogenated Persons must determine whether they 68334–00–9 Cottonseed oil, hydrogenated must report under this section for each 68334–28–1 Fats and glyceridic oils, vegetable, hydro- chemical substance that they manufac- genated 68409–76–7 Bone meal, steamed ture (including import) at an indi- 68424–45–3 Fatty acids, linseed-oil vidual site.

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(a) Persons subject to recurring report- (c) The person manufactured the ing. Any person who manufactured (in- chemical substance described in § 710.45 cluding imported) for commercial pur- in a manner described in § 720.30(g) or poses 25,000 lbs. (11,340 kg) or more of a (h) of this chapter. chemical substance described in § 710.45 at any single site owned or controlled § 710.52 Reporting information to EPA. by that person at any time during cal- Any person who must report under endar year 2005 or during the calendar this subpart, as described in § 710.48, year at 5–year intervals thereafter is must submit the information described subject to reporting. in this section for each chemical sub- (b) Special provisions for importers. For stance described in § 710.45 that the per- purposes of this section, the site for a son manufactured (including imported) person who imports a chemical sub- for commercial purposes in an amount stance described in § 710.45 is the site of of 25,000 lbs. (11,340 kg) or more at any the operating unit within the person’s one site during calendar year 2005 or organization which is directly respon- during the calendar year at 5–year in- sible for importing the substance and tervals thereafter. (See § 710.48(b) for which controls the import transaction. the ‘‘site’’ for importers). A separate The import site may in some cases be form must be submitted for each chem- the organization’s headquarters in the ical substance at each site for which United States (see also § 710.55(b)). the submitter is required to report. A [68 FR 890, Jan. 7, 2003, as amended at 70 FR submitter of information under this 75069, Dec. 19, 2005] subpart must report information as described in paragraphs (c)(1), (c)(2), and § 710.49 Persons not subject to this (c)(3) of this section to the extent that subpart. such information is known to or reason- A person described in § 710.48 is not ably ascertainable by that person where- subject to the requirements of this sub- as a submitter must report information part if that person qualifies as a small as described in paragraph (c)(4) of this manufacturer as that term is defined in section only to the extent that such in- § 704.3 of this chapter. Notwithstanding formation is readily obtainable by that this exclusion, a person who qualifies person. A submitter under this subpart as a small manufacturer is subject to must report information that applies this subpart with respect to any chem- to the calendar year for which the per- ical substance that is the subject of a son is required to report (i.e., calendar rule proposed or promulgated under year 2005 and the calendar year at 5– section 4, 5(b)(4), or 6 of the Act, or is year intervals thereafter). the subject of an order in effect under (a) Reporting in writing. Any person section 5(e) of the Act, or is the subject who chooses to report information to of relief that has been granted under a EPA in writing must do so by com- civil action under section 5 or 7 of the pleting the reporting form available Act. from EPA at the address set forth in § 710.59. The form must include all in- § 710.50 Activities for which reporting formation described in paragraph (c) of is not required. this section. Persons reporting in writ- A person described in § 710.48 is not ing must submit a separate form for subject to the requirements of this sub- each site for which the person is re- part with respect to any chemical sub- quired to report. stance described in § 710.45 that the per- (b) Reporting by magnetic media. Any son solely manufactured or imported person who chooses to report informa- under the following circumstances: tion to EPA by means of magnetic (a) The person manufactured or im- media must submit the information de- ported the chemical substance described in paragraph (c) of this section. scribed in § 710.45 solely in small quan- Magnetic media submitted in response tities for research and development. to this subpart must meet EPA speci- (b) The person imported the chemical fications, as described in the instruc- substance described in § 710.45 as part of tion booklet available from EPA at the an article. address set forth in § 710.59.

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(c) Information to be reported. Manu- plant site reported, and the county or facturers (including importers) of a re- parish (or other jurisdictional indi- portable chemical substance in an cator) in which the plant site is lo- amount of 25,000 lbs. (11,340 kg) or more cated. at a site during a reporting year must (3) Specific information for chemicals report the information described in manufactured in amounts of 25,000 lbs. or paragraphs (c)(1), (c)(2), and (c)(3) of more. The following chemical-specific this section. Manufacturers (including information must be reported for each importers) of a reportable chemical reportable chemical substance manu- substance in an amount of 300,000 lbs. factured at (including imported into) (136,077 kg) or more at a site during a each site in amounts of 25,000 lbs. reporting year must report the infor- (11,340 kg) or more during calendar mation described in paragraph (c)(4) of year 2005 or during the calendar year at this section in addition to the informa- 5–year intervals thereafter: tion described in paragraphs (c)(1), (i) The specific chemical name and (c)(2), and (c)(3) of this section. As de- CAS Number of each reportable chem- scribed in § 710.46(b)(3), manufacturers ical substance at each site. A sub- of certain inorganic chemical submitter under this subpart may use an stances are not required to report the EPA-designated Accession Number for information described in paragraph confidential substances, or a (c)(4) of this section during the 2006 premanufacture notice (PMN) case submission period, but are required to number (see § 720.65 of this chapter) in report this information during subse- lieu of a CAS Number when a CAS quent submission periods. As described Number is not known to or reasonably in § 710.46(b)(1) and (b)(2), manufactur- ascertainable by the submitter. In ad- ers of certain chemicals are not re- dition to reporting the number itself, quired to report the information de- submitters must specify the type of scribed in paragraph (c)(4) of this sec- number they are reporting by selecting tion. from among the following codes: (1) A certification statement signed and dated by an authorized official of the sub- CODES TO SPECIFY TYPE OF CHEMICAL mitter company. Persons reporting by IDENTIFYING NUMBER means of magnetic media must submit Codes Number Type this information on the reporting form available as described in § 710.59. A ...... Accession Number C ...... CAS Registry Number (2) Company and plant site information. P ...... PMN Number The following company and plant site information must be reported for each (ii) A statement indicating, for each site at which at least 25,000 lbs. (11,340 reportable chemical substance at each kg) of a reportable chemical substance site, whether the substance is manufac- is manufactured (including imported) tured in the United States, imported during calendar year 2005 or during the into the United States, or both manu- calendar year at 5–year intervals there- factured in the United States and im- after (see § 710.48(b) for the ‘‘site’’ for ported into the United States. importers): (iii) A designation indicating, for (i) The name of a person who will each reportable chemical substance at serve as technical contact for the sub- each site, whether the substance is mitter company, and who will be able site-limited. to answer questions about the informa- (iv) The total volume (in pounds) of tion submitted by the company to each reportable chemical substance EPA, the company name and Dun and manufactured and imported at each Bradstreet Number, the contact per- site. The total manufactured volume son’s full mailing address, the contact (not including imported volume) and person’s telephone number and the con- the total imported volume must be sep- tact person’s e-mail address. arately reported. This amount must be (ii) The name and full street address reported to two significant figures of of each site. A submitter under this accuracy provided that the reported subpart must include the appropriate figures are within ±10% of the actual Dun and Bradstreet Number for each volume.

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(v) The total number of workers rea- report as many physical forms as apply sonably likely to be exposed to each re- from among the physical forms listed portable chemical substance at each below: site. For each reportable substance at (A) Dry powder. each site, the submitter must select (B) Pellets or large crystals. from among the ranges of workers list- (C) Water- or solvent-wet solid. ed in the following table and report the (D) Other solid. corresponding code (i.e., W1 through (E) Gas or vapor. W8): (F) Liquid. CODES FOR REPORTING NUMBER OF WORKERS (viii) Submitters must report the per- REASONABLY LIKELY TO BE EXPOSED centage, rounded off to the closest 10%, of total production volume of the re- Codes Range portable chemical substance, reported W1 ...... Less than 10 workers in response to paragraph (c)(3)(iv) of W2 ...... At least 10 but less than 25 workers this section, that is associated with W3 ...... At least 25 but less than 50 workers each physical form reported under W4 ...... At least 50 but less than 100 workers W5 ...... At least 100 but less than 500 workers paragraph (c)(3)(vii) of this section. W6 ...... At least 500 but less than 1,000 workers (4) Specific information for chemical W7 ...... At least 1,000 but less than 10,000 workers substances manufactured in amounts of W8 ...... At least 10,000 workers 300,000 lbs. or more. In addition to the (vi) The maximum concentration, information required under paragraphs measured by percentage of weight, of (c)(1), (c)(2), and (c)(3) of this section, each reportable chemical substance at the following information must be re- the time it is sent off-site from each ported for each reportable chemical site. If the chemical is site-limited, substance manufactured (including im- you must report the maximum con- ported) in an amount of 300,000 lbs. centration, measured by percentage of (136,077 kg) or more at any one site dur- weight, of the reportable chemical sub- ing calendar year 2005 or during the stance at the time it is reacted on-site calendar year at 5–year intervals there- to produce a different chemical sub- after. Persons subject to paragraph stance. This information must be re- (c)(4) of this section must report the in- ported regardless of the physical formation described in paragraphs form(s) in which the substance is sent (c)(4)(i) and (c)(4)(ii) of this section for off-site/reacted on-site. For each sub- each reportable chemical substance at stance at each site, select the max- sites under their control and at sites imum concentration of the substance that receive a reportable chemical sub- from among the ranges listed in the stance from the submitter directly or following table and report the cor- indirectly (including through a broker/ responding code (i.e., M1 through M5): distributor, from a customer of the submitter, etc.). Information reported CODES FOR REPORTING MAXIMUM in response to this paragraph must be CONCENTRATION OF CHEMICAL SUBSTANCE reported only to the extent that it is readily obtainable by the submitter. Codes Concentration Range (% weight) Information required to be reported M1 ...... Less than 1% by weight under this paragraph is limited to do- M2 ...... From 1 to 30% by weight mestic (i.e., within the custom terri- M3 ...... From 31 to 60% by weight M4 ...... From 61 to 90% by weight tory of the United States) processing M5 ...... Greater than 90% by weight and use activities. If information responsive to a given data requirement (vii) The physical form(s) of the re- under this paragraph, including infor- portable chemical substance as it is mation in the form of an estimate, is sent off-site from each site. If the not readily obtainable, the submitter is chemical is site-limited, you must re- not required to respond to the require- port the physical form(s) of the report- ment. able chemical substance at the time it (i) Industrial processing and use infor- is reacted on-site to produce a different mation. (A) A designation indicating chemical substance. For each sub- the type of industrial processing or use stance at each site, the submitter must operation(s) at each site that receives a

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reportable substance from the sub- substance, submitters need only report mitter site directly or indirectly the 10 unique combinations for the (whether the recipient site(s) are con- chemical substance that cumulatively trolled by the submitter site or not). represent the largest percentage of the For each chemical substance, report submitter’s production volume for that the letters which correspond to the ap- chemical, measured by weight. propriate processing or use operation(s). A particular designation may CODES FOR REPORTING INDUSTRIAL FUNCTION need to be reported more than once, to CATEGORIES the extent that a submitter reports Codes Category more than one NAICS code (under paragraph (c)(4)(i)(B) of this section) U01 ...... Adsorbents and absorbents that applies to a given designation U02 ...... Adhesives and binding agents U03 ...... Aerosol propellants under this paragraph. U04 ...... Agricultural chemicals (non-pesticidal) U05 ...... Anti-adhesive agents Designation Operation U06 ...... Bleaching agents U07 ...... Coloring agents, dyes PC ...... Processing as a reactant U08 ...... Coloring agents, pigments PF ...... Processing - incorporation into formulation, U09 ...... Corrosion inhibitors and anti-scaling agents mixture or reaction product U10 ...... Fillers PA ...... Processing - incorporation into article U11 ...... Fixing agents PK ...... Processing - repackaging U ...... Use - non-incorporative activities U12 ...... Flame retardants U13 ...... Flotation agents U14 ...... Fuels (B) The five-digit North American In- U15 ...... Functional fluids dustrial Classification System (NAICS) U16 ...... Intermediates codes which best describe the indus- U17 ...... Lubricants trial activities associated with each in- U18 ...... Odor agents U19 ...... Oxidizing agents dustrial processing or use operation re- U20 ...... pH-regulating agents ported under paragraph (c)(4)(i)(A) of U21 ...... Photosensitive chemicals this section. Information about how to U22 ...... Plating agents and metal surface treating agents find these codes is provided in the in- U23 ...... Processing aid, not otherwise listed struction booklet available from EPA U24 ...... Process regulators, used in vulcanization or at the address set forth in § 710.59. A polymerization processes particular NAICS code may need to be U25 ...... Process regulators, other than polymerization or vulcanization processes reported more than once, to the extent U26 ...... Reducing agents that a submitter reports more than one U27 ...... Solvents (for cleaning or degreasing) industrial function code (under para- U28 ...... Solvents (which become part of product for- graph (c)(4)(i)(C) of this section) that mulation or mixture) U29 ...... Solvents (for chemical manufacture and applies to a given NAICS code under processing and are not part of product at this paragraph. greater than one percent by weight) (C) For each NAICS code reported U30 ...... Stabilizers U31 ...... Surface active agents under paragraph (c)(4)(i)(B) of this sec- U32 ...... Viscosity adjustors tion, code(s) from the following list U33 ...... Other must be selected to designate the industrial function category(ies) that (D) The estimated percentage, round- best represents the specific manner in ed off to the closest 10%, of total pro- which the chemical substance is used. duction volume of the reportable chem- A particular industrial function cat- ical substance associated with each egory may need to be reported more combination of industrial processing or than once, to the extent that a sub- use operation, NAICS code and indus- mitter reports more than one industrial function category. Where a par- trial processing or use operation/ ticular combination of industrial proc- NAICS code combination (under para- essing or use operation, NAICS code graphs (c)(4)(i)(A) and (c)(4)(i)(B) of this and industrial function category ac- section) that applies to a given indus- counts for 5% or less of the submitter’s trial function category under this para- site’s total production volume of a re- graph. If more than 10 unique combina- portable chemical substance, the per- tions of industrial processing or use op- centage must not be rounded off to zero erations/NAICS codes/industrial func- % if the production volume attrib- tion categories apply to a chemical utable to that industrial processing or

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use operation, NAICS code and indus- the 10 codes for the chemical substance trial function category combination is that cumulatively represent the larg- 300,000 lbs. (136,077 kg) or more during est percentage of the submitter’s pro- the reporting year. Instead, in such a duction volume for that chemical, case, submitters must report the per- measured by weight: centage, rounded off to the closest 1%, of the submitter’s site’s total produc- CODES FOR REPORTING COMMERCIAL AND tion volume of the reportable chemical CONSUMER PRODUCT CATEGORIES substance associated with the par- Codes Category ticular combination of industrial processing or use operation, NAICS code C01 ...... Adhesives and sealants and industrial function category. C02 ...... Agricultural products (non-pesticidal) C03 ...... Artists’ supplies (E) For each combination of indus- C04 ...... Automotive care products trial processing or use operation, C05 ...... Electrical and electronic products NAICS code and industrial function C06 ...... Fabrics, textiles and apparel C07 ...... Glass and ceramic products category, the submitter must estimate C08 ...... Lawn and garden products (non-pesticidal) the number of sites at which each re- C09 ...... Leather products portable chemical substance is proc- C10 ...... Lubricants, greases and fuel additives C11 ...... Metal products essed or used. For each combination as- C12 ...... Paints and coatings sociated with each substance, the sub- C13 ...... Paper products mitter must select from among the C14 ...... Photographic supplies C15 ...... Polishes and sanitation goods ranges of sites listed in the following C16 ...... Rubber and plastic products table and report the corresponding C17 ...... Soaps and detergents code (i.e., S1 through S7): C18 ...... Transportation products C19 ...... Wood and wood furniture C20 ...... Other CODES FOR REPORTING NUMBERS OF SITES

Codes Range (B) Submitters must determine, within each commercial and consumer S1 ...... less than 10 sites S2 ...... at least 10 but less than 25 sites product category reported under para- S3 ...... at least 25 but less than 100 sites graph (c)(4)(ii)(A) of this section, S4 ...... at least 100 but less than 250 sites whether any amount of each reportable S5 ...... at least 250 but less than 1,000 sites chemical substance manufactured (in- S6 ...... at least 1,000 but less than 10,000 sites S7 ...... 10,000 or more sites cluding imported) by the submitter is present in (for example, a plasticizer (F) For each combination of indus- chemical used to make pacifiers) or on trial processing or use operation, (for example, as a component in the NAICS code and industrial function paint on a toy) any consumer products category, the submitter must estimate intended for use by children up to the the number of workers reasonably like- age of 14, regardless of the concentra- ly to be exposed to each reportable tion of the substance remaining in or chemical substance. For each combina- on the product. Submitters must select tion associated with each substance, from the following options: the chem- the submitter must select from among ical substance is used in or on any con- the worker ranges listed in paragraph sumer products intended for use by (c)(3)(v) of this section and report the children, the chemical substance is not corresponding code (i.e., W1 though used in or on any consumer products W8). intended for use by children, or infor- (ii) Commercial and consumer use information as to whether the chemical sub- mation. (A) Using the codes listed in stance is used in or on any consumer this paragraph, submitters must des- products intended for use by children is ignate the commercial and consumer not readily obtainable. product category or categories that (C) The estimated percentage, round- best describe the commercial and con- ed off to the closest 10%, of the submit- sumer products in which each report- ter’s site’s total production volume of able chemical substance is used the reportable chemical substance as- (whether the recipient site(s) are con- sociated with each commercial and trolled by the submitter site or not). If consumer product category. Where a more than 10 codes apply to a chemical particular commercial and consumer substance, submitters need only report product category accounts for 5% or

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less of the total production volume of a wise be from June 1, 2011 to September reportable chemical substance, the per- 30, 2011) is suspended. centage must not be rounded off to zero [70 FR 75069, Dec. 19, 2005, as amended at 71 % if the production volume attrib- FR 76206, Dec. 20, 2006; 76 FR 27273, May 11, utable to that commercial and con- 2011] sumer product category is 300,000 lbs. (136,077 kg) or more during the report- § 710.55 Duplicative reporting. ing year. Instead, in such a case, sub- (a) With regard to section 8(a) rules. mitters must report the percentage, Any person subject to the requirements rounded off to the closest 1%, of the of this part who previously has com- submitter’s site’s total production vol- plied with reporting requirements of a ume of the reportable chemical sub- rule under section 8(a) of the Act by stance associated with the particular submitting the information described commercial and consumer product cat- in § 710.52 for a chemical substance de- egory. scribed in § 710.45 to EPA, and has done (D) Where the reportable chemical so within 1 year of the start of a sub- substance is used in commercial or mission period described in § 710.53, is consumer products, the estimated typ- not required to report again on the ical maximum concentration, meas- manufacture of that substance at that ured by weight, of the chemical sub- site during that submission period. stance in each commercial and con- (b) With regard to importers. This part sumer product category reported under requires that only one report be subparagraph (c)(4)(ii)(A) of this section. mitted on each import transaction in- For each substance in each commercial volving a chemical substance described in § 710.45. When two or more persons and consumer product category re- are involved in a particular import ported under paragraph (c)(4)(ii)(A) of transaction and each person meets the this section, submitters must select Agency’s definition of ‘‘importer’’ as from among the ranges of concentra- set forth in §§ 710.3 and 704.3 of this tions listed in the table in paragraph chapter, they may determine among (c)(3)(vi) of this section and report the themselves who should submit the re- corresponding code (i.e., M1 through quired report; if no report is submitted M5). as required under this part, EPA will [68 FR 890, Jan. 7, 2003, as amended at 69 FR hold each such person liable for failure 40791, July 7, 2004; 70 FR 75069, Dec. 19, 2005; to report. 71 FR 52498, Sept. 6, 2006] § 710.57 Recordkeeping requirements. § 710.53 When to report. Each person who is subject to the re- All information reported to EPA in porting requirements of this subpart response to the requirements of this must retain records that document any subpart must be submitted during an information reported to EPA. Records applicable submission period. The first relevant to reporting during a submis- submission period is from August 25, sion period must be retained for a pe- 2006, to March 23, 2007. Subsequent re- riod of 5 years beginning on the last curring submission periods are from day of the submission period. Submit- June 1 to September 30 at 5–year inter- ters are encouraged to retain their vals after the first submission period. records longer than 5 years to ensure Any person described in § 710.48(a) must that past records are available as a ref- report during each submission period erence when new submissions are being for each chemical substance described generated. in § 710.45 that the person manufac- [70 FR 75070, Dec. 19, 2005] tured (including imported) during the preceding calendar year (i.e., the ‘‘re- § 710.58 Confidentiality. porting year’’). Notwithstanding the (a) Any person submitting informa- foregoing, and without any alteration tion under this subpart may assert a of the status or timing of any subse- business confidentiality claim for the quent submission period, the second information at the time it is sub- submission period (which would other- mitted. These claims will apply only to

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the information submitted with the available to the public, for example in claim. New confidentiality claims, if technical journals, libraries, or State, necessary, must be asserted with re- local, or Federal agency public files? gard to information submitted during (vi) What measures have been taken the next submission period. Guidance to prevent undesired disclosure of the for asserting confidentiality claims is fact that the chemical substance is provided in the instruction booklet being manufactured (including im- identified in § 710.59. Information ported) for a commercial purpose? claimed as confidential in accordance (vii) To what extent has the fact that with this section will be treated and this chemical substance is manufac- disclosed in accordance with the proce- tured (including imported) for commer- dures in part 2 of this chapter. cial purposes been revealed to others? (b) Chemical identity. A person may What precautions have been taken reassert a claim of confidentiality for the garding these disclosures? Have there chemical identity of a specific chem- been public disclosures or disclosures ical substance only if the identity of to competitors? that substance is treated as confiden- (viii) Does this particular chemical tial in the Master Inventory File as of substance leave the site of manufac- the time the report is submitted for ture (including import) in any form, that substance under this subpart. The e.g., as product, effluent, emission? If following steps must be taken to assert so, what measures have been taken to a claim of confidentiality for the iden- guard against the discovery of its identity of a reportable chemical sub- tity? stance: (1) The submitter must submit with (ix) If the chemical substance leaves the report detailed written answers to the site in a product that is available the following questions signed and to the public or your competitors, can dated by an authorized official. the substance be identified by analysis (i) What harmful effects to your com- of the product? petitive position, if any, do you think (x) For what purpose do you manu- would result from the identity of the facture (including import) the sub- chemical substance being disclosed in stance? connection with reporting under this (xi) Has EPA, another Federal agen- subpart? How could a competitor use cy, or any Federal court made any per- such information? Would the effects of tinent confidentiality determinations disclosure be substantial? What is the regarding this chemical substance? If causal relationship between the disclo- so, please attach copies of such deter- sure and the harmful effects? minations. (ii) How long should confidential (2) If any of the information con- treatment be given? Until a specific tained in the answers to the questions date, the occurrence of a specific event, listed in paragraph (b)(1) of this section or permanently? Why? is asserted to contain confidential busi- (iii) Has the chemical substance been ness information, the submitter must patented? If so, have you granted li- clearly identify the information that is censes to others with respect to the claimed confidential by marking the patent as it applies to the chemical specific information on each page with substance? If the chemical substance a label such as ‘‘confidential business has been patented and therefore dis- information,’’ ‘‘proprietary,’’ or ‘‘trade closed through the patent, why should secret.’’ it be treated as confidential? (c) Site identity. A submitter may as- (iv) Has the identity of the chemical sert a claim of confidentiality for a substance been kept confidential to the site only if the linkage of the site with extent that your competitors do not a reportable chemical is confidential know it is being manufactured or im- and not publicly available. The fol- ported for a commercial purpose by lowing steps must be taken to assert a anyone? claim of confidentiality for a site iden- (v) Is the fact that the chemical sub- tity: stance is being manufactured (includ- (1) The submitter must submit with ing imported) for a commercial purpose the report detailed written answers to

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the following questions signed and tions for completing and submitting an dated by an authorized official: electronic or hard copy report. Instruc- (i) Has site information been linked tions given in the EPA publication ti- with a chemical identity in any other tled, ‘‘Instructions for Reporting for Federal, state or local reporting the 2006 Partial Updating of the TSCA scheme? For example, is the chemical Chemical Inventory Database,’’ are identity linked to a facility in a filing available as described in paragraph (c) under the Emergency Planning and of this section. EPA encourages report- Community Right-to-Know Act ing sites subject to this part to submit (EPCRA) section 311, namely through a the required information to EPA elec- Material Safety Data Sheet (MSDS)? If tronically. so, identify all such schemes. Was the (c) Obtain the reporting package and linkage claimed as confidential in any copies of the form. You can obtain the of these instances? reporting form or software, reporting (ii) What harmful effect, if any, to instructions, and other associated doc- your competitive position do you think uments as follows: would result from the identity of the (1) By website. Go to the EPA Inven- site and the chemical substance being tory Update Reporting Internet home disclosed in connection with reporting page at http://www.epa.gov/oppt/iur and under this subpart? How could a com- follow the appropriate links. EPA en- petitor use such information? Would courages reporting sites subject to this the effects of disclosure be substantial? subpart to visit this home page. What is the causal relationship be- (2) By phone. Call the EPA TSCA tween the disclosure and the harmful Hotline at (202) 554–1404. effects? (3) By e-mail. Send an e-mail request (2) If any of the information con- for this information to the EPA TSCA tained in the answers to the questions Hotline at [email protected]. listed in paragraph (c)(1) of this section (4) By mail. Send a written request is asserted to contain confidential busi- for this information to the following ness information, the submitter must address: TSCA Hotline, Mail Code clearly identify the information that is 7408M, ATTN: Inventory Update Re- claimed confidential by marking the porting, Office of Pollution Prevention specific information on each page with and Toxics, U.S. Environmental Pro- a label such as ‘‘confidential business tection Agency, 1200 Pennsylvania information,’’ ‘‘proprietary,’’ or ‘‘trade Ave., NW., Washington, DC 20460–0001. secret.’’ [71 FR 52498, Sept. 6, 2006] (d) If no claim of confidentiality is indicated on the reporting form submitted to EPA under this subpart, or if PART 712—CHEMICAL confidentiality claim substantiation INFORMATION RULES required under paragraphs (b) and (c) of this section is not submitted with the Subpart A—General Provisions reporting form, EPA may make the in- Sec. formation available to the public with- 712.1 Scope and compliance. out further notice to the submitter. 712.3 Definitions. 712.5 Method of identification of substances [68 FR 890, Jan. 7, 2003, as amended at 69 FR for reporting purposes. 40791, July 7, 2004] 712.7 Report of readily obtainable information for subparts B and C. § 710.59 Availability of reporting form 712.15 Confidentiality. and instructions. (a) Use the proper EPA form. You must Subpart B—Manufacturers Reporting— use the EPA form identified as ‘‘Form Preliminary Assessment Information U’’ to submit written information in 712.20 Manufacturers and importers who response to the requirements of this must report. subpart. Instructions for obtaining cop- 712.25 Exempt manufacturers and import- ies of Form U are in paragraph (c) of ers. this section. 712.28 Form and instructions. (b) Follow the reporting instructions. 712.30 Chemical lists and reporting periods. You should follow the detailed instruc- AUTHORITY: 15 U.S.C. 2607(a).

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SOURCE: 47 FR 26998, June 22, 1982, unless chemical substance as part of a mix- otherwise noted. ture or article, into the customs territory of the U.S. and includes the per- Subpart A—General Provisions son liable for the payment of any duties on the merchandise, or an author- § 712.1 Scope and compliance. ized agent on his behalf. Importer also (a) This part establishes procedures includes, as appropriate: for chemical manufacturers and proc- (1) The consignee. essors to report production, use, and (2) The importer of record. exposure-related information on listed (3) The actual owner if an actual chemical substances. Subpart A estab- owner’s declaration and superseding lishes requirements that apply to all bond has been filed in accordance with reporting under this part. Subpart B 19 CFR 141.20. covers manufacturers’ and processors’ (4) The transferee, if the right to reporting. withdraw merchandise in a bonded (b) Chemical substances, mixtures, warehouse has been transferred in ac- and categories of substances or mix- cordance with subpart C of 19 CFR part tures which have been recommended by 144. For the purposes of this definition, the Interagency Testing Committee for the customs territory of the U.S. con- testing consideration by the Agency sists of the 50 states, Puerto Rico, and but not designated for Agency response the District of Columbia. within 12 months, will be added to (e) Impurity means a chemical sub- § 712.30 using the procedure specified in stance unintentionally present with § 712.30(c) only to the extent that the another chemical substance or mix- total number of designated and rec- ture. ommended chemicals has not exceeded (f) Intermediate means any chemical 50 in any 1 year. Additional rec- substance that is consumed, in whole ommended but not designated chemi- or in part, in chemical reactions used cals may be added after proposal, and for the intentional manufacture of consideration of public comment. other chemical substances or mixtures, [47 FR 26998, June 22, 1982, as amended at 50 or that is intentionally present for the FR 34809, Aug. 28, 1985; 60 FR 31921, June 19, purpose of altering the rates of such 1995] chemical reactions. (See also paragraph (j) of this section.) § 712.3 Definitions. (g) Known to or reasonably ascertain- The definitions in section 3 of TSCA, able by means all information in a per- 15 U.S.C. 2602, apply for this part. In son’s possession or control, plus all in- addition, the following definitions formation that a reasonable person apply: similarly situated might be expected to (a) Byproduct means any chemical possess, control, or know, or could ob- substance or mixture produced without tain without unreasonable burden. a separate commercial intent during (h) Manufacture for commercial pur- the manufacture, processing, use, or poses means to import, produce, or disposal of another chemical substance manufacture with the purpose of ob- or mixture. taining an immediate or eventual com- (b) EPA means the U.S. Environ- mercial advantage for the manufac- mental Protection Agency. turer and includes, among other (c) Import in bulk form means to im- things, such ‘‘manufacture’’ of any port a chemical substance (other than amount of a chemical substance or as part of a mixture or article) in any mixture: quantity, in cans, bottles, drums, bar- (1) For commercial distribution, in- rels, packages, tanks, bags, or other cluding for test marketing. containers used for purposes of trans- (2) For use by the manufacturer, in- portation or containment, if the chem- cluding use for product research and ical substance has an end use or com- development, or as an intermediate. mercial purpose separate from the con- Manufacture for commercial purposes tainer. also applies to substances that are pro- (d) Importer means anyone who im- duced coincidentally during the manu- ports a chemical substance, including a facture, processing, use, or disposal of

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another substance or mixture, includ- ture, partnership, sole proprietorship, ing byproducts and coproducts that are association, or any other business enti- separated from that other substance or ty, any State or political subdivision mixture, and impurities that remain in thereof, any municipality, any inter- that substance or mixture. Byproducts state body, and any department, agen- and impurities may not in themselves cy, or instrumentality of the Federal have commercial value. They are none- government. theless produced for the purpose of ob- (m) Process for commercial purposes taining a commercial advantage since means the preparation of a chemical they are part of the manufacture of a substance or mixture, after its manu- chemical produced for a commercial facture, for distribution in commerce purpose. with the purpose of obtaining an imme- (i) Mixture means any combination of diate or eventual commercial advan- two or more chemical substances if the tage for the processor. Processing of combination does not occur in nature any amount of a chemical substance or and is not, in whole or in part, the re- mixture is included. If a chemical or sult of a chemical reaction; except that mixture containing impurities is proc- mixture does include (1) any combina- essed for commercial purposes, then tion which occurs, in whole or in part, those impurities are also processed for as a result of a chemical reaction if the commercial purposes. combination could have been manufac- (n) Site means a contiguous property tured for commercial purposes without unit. Property divided only by a public a chemical reaction at the time the right-of-way shall be considered one chemical substances comprising the site. There may be more than one man- combination were combined, and if all ufacturing plant on a single site. of the chemical substances comprising (o) Test marketing means distributing the combination are included in the in commerce a limited amount of a EPA, TSCA Chemical Substance Inven- chemical substance or mixture, or arti- tory after the effective date of the cle containing such substance or mix- premanufacture notification require- ture, to a defined number of potential ment under 40 CFR part 720, and (2) hy- customers, during a predetermined drates of a chemical substance or hy- testing period, to explore market capa- drated ions formed by association of a bility prior to broader distribution in chemical substance with water. The commerce. term mixture includes alloys, inor- (p) TSCA means the Toxic Substances ganic glasses, ceramics, frits, and ce- Control Act, 15 U.S.C. 2601 et seq. ments, including Portland cement. (j) Non-isolated intermediate means § 712.5 Method of identification of sub- any intermediate that is not inten- stances for reporting purposes. tionally removed from the equipment (a) Report on TSCA-regulable quan- in which it is manufactured, including tities. Unless specifically otherwise re- the reaction vessel in which it is manu- quired, respondents must report only factured, equipment which is ancillary about quantities of a chemical that is to the reaction vessel, and any equip- defined as a chemical substance under ment through which the substance TSCA section 3(2). passes during a continuous flow proc- (b) Chemicals from natural sources. A ess, but not including tanks or other manufacturer of a chemical substance vessels in which the substance is stored which is extracted from an ore, from after its manufacture. (See also para- oil, or from any other natural source graph (f) of this section.) must report only about the manufac- (k) Owned or controlled by the parent turing steps for, and the uses of, that company means the parent owns or con- chemical, not about production of the trols 50 percent or more of the other natural source material or other crude company’s voting stock or other equity precursors derived from the natural rights, or has the power to control the source material. management and policies of the other For example, persons who manufacture a company. chemical substance such as ‘‘sweetened (l) Person means any natural person, naphtha, 64741–87–3,’’ but do not refine the firm, company, corporation, joint ven- naphtha to produce ‘‘hexane, 110–54–3’’ would

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not report on hexane. Only the production of (b) Persons must certify to the valid- ‘‘hexane’’ as an isolated product must be re- ity of a claim of confidentiality they ported—not previous production of more make for information reported under crude, complex substances such as naphtha this part, as specified on the reporting from which hexane is extracted. Thus, persons who produce crude oil, ores, and other form. crude natural materials, but do not carry (c) If no claim accompanies the infor- them through further manufacturing steps mation at the time it is submitted to that produce a listed chemical have no re- EPA or if certification as to the claim porting responsibilities under this Part. is not made on the reporting form, Note, however, that any method of extrac- EPA may place the information in an tion, refinement, or purification of a listed open file available to the public with- chemical substance is considered to be man- out further notice to the submitter. ufacturing for the purposes of this rule. (c) Chemical substances as marketed. Subpart B—Manufacturers Report- This part requires reporting about ing—Preliminary Assessment chemical substances as they are marketed or used in practice. The fol- Information lowing preparations of a chemical sub- § 712.20 Manufacturers and importers stance must be reported as the sub- who must report. stance itself, not as a mixture, since Except as described in § 712.25, at the these preparations are regarded as the time a chemical substance is listed in substance in practice. § 712.3, the following persons must sub- (1) The chemical substance in aque- mit the ‘‘Manufacturer’s Report—Pre- ous solution. liminary Assessment Information’’ (as (2) The chemical substance con- described in § 712.28) for each plant site taining an additive (such as a stabilizer at which they manufactured or im- or other chemical) to maintain the in- ported the chemical substance during tegrity or physical form of the sub- the reporting period specified in stance. § 712.30: (3) The chemical substance in any (a) Persons who manufactured one or grade of purity. more of the chemical substances listed § 712.7 Report of readily obtainable in- in § 712.30 for commercial purposes. formation for subparts B and C. (b) Persons who imported in bulk form one or more of the chemical sub- TSCA section 8(a) authorizes EPA to stances listed in § 712.30 for commercial require persons to report information purposes. that is known to or reasonably ascertainable by them. For purposes of sub- § 712.25 Exempt manufacturers and part B, however, a lesser standard ap- importers. plies. Companies must report informa- (a) Persons who manufactured or im- tion that is readily obtainable by man- ported the chemical substance during agement and supervisory employees re- the reporting period, solely for pur- sponsible for manufacturing, proc- poses of scientific experimentation, essing, distributing, technical services, analysis, or research, including re- and marketing. Extensive file searches search or analysis for product develop- are not required. ment, are not subject to reporting [47 FR 26998, June 22, 1982, as amended at 60 under § 712.20. FR 31921, June 19, 1995] (b) Persons who, during the reporting period, manufactured or imported § 712.15 Confidentiality. fewer than 500 kilograms (1100 pounds) (a) Any person submitting informa- of the chemical substance at a single tion under this part may assert busi- plant site are not subject to reporting ness confidentiality claims for the infor that site under § 712.20. formation as described in the pertinent (c) Persons who qualify as small reporting form and its instructions. manufacturers or importers in respect Any information covered by a claim to a specific chemical substance listed will be disclosed by EPA only as pro- in § 712.30 are exempt. However, this ex- vided in the procedures set forth at 40 emption does not apply with respect to CFR part 2. any chemical in § 712.30 designated by

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an asterisk. A manufacturer is quali- (d) Form 7710–35, Manufacturer’s Re- fied as small and is exempt from sub- port—Preliminary Assessment Infor- mitting a report under this subpart for mation or PAIR form and instructions a chemical substance manufactured at may be obtained by telephoning or a particular plant site if both of the writing the Environmental Assistance following criteria are met: Division. The telephone number and (1) Total annual sales taken together the address of the Environmental As- of all sites owned or controlled by the sistance Division is: Phone Number foreign or domestic parent company (202) 554–1404, TDD (202) 554–0551. Ad- were below $30 million for the report- dress: Environmental Assistance Divi- ing period; sion (7406), Office of Pollution Preven- (2) Total production of the listed sub- tion and Toxics, Environmental Pro- stance for the reporting period was tection Agency, 1200 Pennsylvania below 45,400 kilograms (100,000 pounds) Ave., NW., Washington, DC 20460. at the plant site. (d) Persons are not subject to report- [47 FR 26998, June 22, 1982, as amended at 52 ing under § 712.20 if they manufactured FR 20083, May 29, 1987; 53 FR 12523, Apr. 15, 1988; 60 FR 31921, June 19, 1995; 60 FR 34463, or imported the chemical substance July 3, 1995; 71 FR 47126, Aug. 16, 2006] during the reporting period only in the following forms: § 712.30 Chemical lists and reporting (1) As a byproduct that was not used periods. or sold or that was formed as described (a)(1) Persons subject to this subpart in 40 CFR 710.4(d) (3) through (7). B must submit a Preliminary Assess- (2) As a non-isolated intermediate. ment Information Manufacturer’s Re- (3) As an impurity. port for each chemical substance or [47 FR 26998, June 22, 1982; 47 FR 28382, June mixture that is listed or designated in 30, 1982] this section. (2) Unless a respondent has already § 712.28 Form and instructions. prepared a Manufacturer’s Report in (a) Manufacturers and importers sub- conformity with conditions set forth in ject to this subpart must submit a sin- paragraph (a)(3) of this section, the in- gle EPA Form No. 7710–35, ‘‘Manufac- formation in each Manufacturer’s Re- turer’s Report—Preliminary Assess- port must cover the respondent’s latest ment Information,’’ for each plant site complete corporate fiscal year as of the manufacturing or importing a chem- effective date. The effective date will ical substance listed in § 712.30. be 30 days after the FEDERAL REGISTER (b) Reporting companies may submit publishes a rule amendment making their reports through individual plant the substance or mixture subject to sites or company headquarters as they this subpart B. choose. A separate form must be sub- (3) Persons subject to this subpart B mitted for each plant site manufac- need not comply with the requirements turing the chemical substance. of paragraph (a)(2) of this section if (c) You must submit forms by one of they meet either one of the following the following methods: conditions: (1) Mail, preferably certified, to the (i) The respondent has previously and Document Control Office (DCO) voluntarily provided EPA with a Manu- (7407M), Office of Pollution Prevention facturer’s Report on a chemical sub- and Toxics (OPPT), Environmental stance or mixture subject to this sub- Protection Agency, 1200 Pennsylvania part B, which contains data for a one- Ave., NW., Washington, DC 20460–0001, year period ending no more than three ATTN: 8(a) PAIR Reporting. years prior to the effective date de- (2) Hand delivery to OPPT Document scribed in paragraph (a)(2) of this sec- Control Office (DCO), EPA East, Rm. tion. Respondents meeting this condi- 6428, 1201 Constitution Ave., NW., tion must notify EPA by letter of their Washington, DC, ATTN: 8(a) PAIR Re- desire to have the voluntary submis- porting. The DCO is open from 8 a.m. sion used in lieu of a current data sub- to 4 p.m., Monday through Friday, ex- mission and must verify the complete- cluding legal holidays. The telephone ness and current accuracy of the volun- number for the DCO is (202)564–8930. tarily submitted data. Such letters

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must contain the following language: the section 4(e) Priority List, for test- ‘‘I hereby certify that, to the best of ing consideration by the Agency, will my knowledge and belief, all informa- be added to this section 30 days after tion entered on this form is complete EPA issues for publication in the FED- and accurate. I agree to permit access ERAL REGISTER a rule amendment list- to, and the copying of records by, a ing these chemical substances, mix- duly authorized representative of the tures and categories. A Preliminary EPA Administrator, in accordance Assessment Information—Manufactur- with the Toxic Substances Control Act, er’s Report must be submitted for each to document any information reported chemical substance and mixture within on the form.’’ Notification letters must 60 days after the effective date of the be submitted prior to the reporting listing. At the discretion of the Assist- deadline. ant Administrator for Prevention, Pes- (ii) The respondent has previously ticides and Toxic Substances, a listed submitted a Manufacturer’s Report on substance, mixture or category may be a chemical substance or mixture sub- withdrawn, for good cause, from the ject to this subpart B to the Inter- rule’s reporting requirements prior to agency Testing Committee, but not to the effective date. Any information EPA, and that Report contained data submitted showing why a substance, for a one-year period ending less than mixture or category should be removed three years prior to the effective date from the rule must be received by EPA described in paragraph (a)(2) of this within 14 days after the date of publi- section. Respondents meeting this con- cation of the notice under this para- dition must submit a copy of the Man- graph. If a substance, mixture or cat- ufacturer’s Report to EPA, and must egory is removed, a FEDERAL REGISTER submit an accompanying letter noti- notice announcing this decision will be fying EPA of the respondent’s intent published no later than the effective that the submission be used in lieu of a date of the amendment. current Manufacturer’s Report. The (2) You must submit information by notification letter must verify the one of the following methods: completeness and current accuracy of (i) Mail, preferably certified, to the the voluntarily submitted data. Such a Document Control Office (DCO) letter must contain the following lan- (7407M), Office of Pollution Prevention guage: ‘‘I hereby certify that, to the and Toxics (OPPT), Environmental best of my knowledge and belief, all in- Protection Agency, 1200 Pennsylvania formation entered on this form is com- Ave., NW., Washington, DC 20460–0001, plete and accurate. I agree to permit ATTN: 8(a) Auto-ITC. access to, and the copying of records (ii) Hand delivery to OPPT Document by, a duly authorized representative of Control Office (DCO), EPA East, Rm. the EPA Administrator, in accordance 6428, 1201 Constitution Ave., NW., with the Toxic Substances Control Act, Washington, DC, ATTN: 8(a) Auto-ITC. to document any information reported Reporting. The DCO is open from 8 a.m. on the form.’’ The submission must be to 4 p.m., Monday through Friday, ex- made prior to the reporting deadline. cluding legal holidays. The telephone (b) Except as provided in paragraph number for the DCO is (202)564–8930. (c) of this section, chemical substances (d) Manufacturers and importers of and designated mixtures will be added the substances listed below must sub- after a notice of proposed amendment mit a Preliminary Assessment Infor- of this subpart is published in the FED- mation Manufacturer’s Report for each ERAL REGISTER. There will be a 30 day site at which they manufacture or im- public comment period on each notice; port each substance by the reporting after consideration of the comments, a date shown in the table below. The sub- final amendment will identify the substances are listed in Chemical Ab- stances and mixtures added. stracts Service Registry Number order. (c)(1) Chemical substances, mixtures, Typically EPA lists the trivial or com- and categories of substances or mix- mon name first, then, following the tures that have been added by the symbol ‘‘- -’’, EPA lists the substance Interagency Testing Committee, estab- by its TSCA Chemical Substance In- lished under section 4(e) of TSCA, to ventory name. Whenever EPA lists a

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single name, the name may be either mon name. Generally, when a single the TSCA Chemical Substance Inven- name is listed, it is the TSCA Chemical tory name, a trivial name, or a com- Substances Inventory name.

Effective Reporting CAS No. Substance date date

78-10-4 Ethyl silicate...... 8/23/00 10/23/00 90-30-2 N-Phenyl-1-naphthylamine ...... 9/30/91 11/27/91 100-40-3 4-Vinylcyclohexene ...... 1/11/90 3/12/90 108-95-5 Thiophenol ...... 1/26/94 3/28/94 109-87-5 Methylal ...... 8/23/00 10/23/00 118-79-6 2,4,6-tribromophenol ...... 1/11/90 3/12/90 133-49-3 Pentachlorothiophenol ...... 8/27/01 10/24/01 136–35–6 1-Triazene, 1,3-diphenyl-...... 7/11/03 9/9/03 143-33-9 Sodium cyanide...... 10/29/90 12/27/90 496-46-8 Glycoluril ...... 8/23/00 10/23/00 632-79-1 Tetrabromophthalic anhydride...... 1/11/90 3/12/90 637-92-3 Ethyl tert-butyl ether ...... 12/28/94 2/27/95 994-05-8 Tert-amyl methyl ether ...... 12/28/94 2/27/95 1163-19-5 Decabromodiphenyl ether...... 1/11/90 3/12/90 1198-55-6 Tetrachloropyrocatechol ...... 8/27/01 10/24/01 1806-24-2 p-toluidine, 5-chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl- ...... 8/27/01 10/24/01 3194-55-6 Hexabromocyclododecane ...... 1/11/90 3/12/90 3278–89–5 Benzene, 1,3,5-tribromo-2-(2-propenyloxy)-...... 7/11/03 9/9/03 3296-90-0 Dibromoneopentyl glycol...... 1/11/90 3/12/90 12185-10-3 White phosphorus...... 1/26/94 3/28/94 16691-43-3 3-Amino-5-mercapto-1,2,4-triazole ...... 8/23/00 10/23/00 29091–20–1 Benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)-...... 7/11/03 9/9/03 32534-81-9 Pentabromodiphenyl ether...... 1/11/90 3/12/90 32536-52-0 Octabromodiphenyl ether...... 1/11/90 3/12/90 32588-76-4 Ethylene Bis-(tetrabromophthalimide)...... 1/11/90 3/12/90 37853-59-1 1,2-Bis(tribromophenoxy) ethane...... 1/11/90 3/12/90 41291-34-3 Ethylene(5,6-dibromonorbornane-2,3-dicarboximide) ...... 1/11/90 3/12/90 52907-07-0 Ethylene bis(5,6-dibromonorbornane-2,3-dicarboximide)...... 1/26/94 3/28/94 57137-10-7 Tribrominated polystyrene...... 1/11/90 3/12/90 61262-53-1 Ethylene bis(pentabromophenoxide)...... 1/11/90 3/12/90 68928–76–7 Stannane, dimethylbis[(1-oxoneodecyl)oxy]-...... 7/11/03 9/9/03 88185–22–2 Benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, 2-ethoxy-1-methyl-2-oxoethyl 8/27/01 10/24/01 ester.

(e) Manufacturers and importers of date shown in the table below. The cat- the substances listed below by category egories are listed in alphabetic order must submit a Preliminary Assessment with the chemical substances within Information Manufacturers Report for each category listed by ascending nu- each site at which they manufacture or merical CAS number. import each substance by the reporting

Effective Reporting CAS No. Substance date date

Aldehydes

66-77-3 1-Naphthalenecarboxaldehyde ...... 9/30/91 11/27/91 75-07-0 Acetaldehyde ...... 9/30/91 11/27/91 75-87-6 Acetaldehyde, trichloro-...... 9/30/91 11/27/91 78-84-2 Propanal, 2-methyl-...... 9/30/91 11/27/91 78-85-3 2-Propenal, 2-methyl-...... 9/30/91 11/27/91 80-54-6 Benzenepropanal,4-(1,1-dimethylethyl)-.alpha.-methyl- ...... 9/30/91 11/27/91 84-83-3 Acetaldehyde, (1,3-dihydro-1,3, 3-trimethyl-2H-indol-2-ylidene). 89-98-5 Benzaldehyde, 2-chloro-...... 9/30/91 11/27/91 90-02-8 Benzaldehyde, 2-hydroxy-...... 9/30/91 11/27/91 93-02-7 Benzaldehyde, 2,5-dimethoxy-...... 9/30/91 11/27/91 93-53-8 Benzeneacetaldehyde, .alpha.-methyl-...... 9/30/91 11/27/91 95-01-2 Benzaldehyde, 2,4-dihydroxy-...... 9/30/91 11/27/91 97-51-8 Benzaldehyde, 2-hydroxy-5-nitro-...... 9/30/91 11/27/91 98-01-1 2-Furancarboxaldehyde ...... 9/30/91 11/27/91 98-03-3 2-Thiophenecarboxaldehyde ...... 9/30/91 11/27/91 100-10-7 Benzaldehyde, 4-(dimethylamino)-...... 9/30/91 11/27/91 100-50-5 3-Cyclohexene-1-carboxaldehyde ...... 9/30/91 11/27/91 100-52-7 Benzaldehyde ...... 9/30/91 11/27/91 101-39-3 2-Propenal, 2-methyl-3-phenyl-...... 9/30/91 11/27/91

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Effective Reporting CAS No. Substance date date

Aldehydes

101-86-0 Octanal, 2-(phenylmethylene)-...... 9/30/91 11/27/91 103-95-7 Benzenepropanal, .alpha.-methyl-4-(1-methylethyl)-...... 9/30/91 11/27/91 104-09-6 Benzeneacetaldehyde, 4-methyl-...... 9/30/91 11/27/91 104-55-2 2-Propenal, 3-phenyl-...... 9/30/91 11/27/91 104-87-0 Benzaldehyde, 4-methyl-...... 9/30/91 11/27/91 104-88-1 Benzaldehyde, 4-chloro-...... 9/30/91 11/27/91 106-23-0 6-Octenal, 3,7-dimethyl-...... 9/30/91 11/27/91 106-26-3 2,6-Octadienal, 3,7-dimethyl-, (Z)- ...... 9/30/91 11/27/91 106-72-9 5-Heptenal, 2,6-dimethyl-...... 9/30/91 11/27/91 107-02-8 2-Propenal ...... 9/30/91 11/27/91 107-20-0 Acetaldehyde, chloro-...... 9/30/91 11/27/91 107-22-2 Ethanedial ...... 9/30/91 11/27/91 107-75-5 Octanal, 7-hydroxy-3,7-dimethyl-...... 9/30/91 11/27/91 110-41-8 Undecanal, 2-methyl-...... 9/30/91 11/27/91 110-62-3 Pentanal ...... 9/30/91 11/27/91 111-30-8 Pentanedial ...... 9/30/91 11/27/91 111-71-7 Heptanal ...... 9/30/91 11/27/91 112-31-2 Decanal ...... 9/30/91 11/27/91 112-44-7 Undecanal ...... 9/30/91 11/27/91 112-45-8 10-Undecenal ...... 9/30/91 11/27/91 112-54-9 Dodecanal ...... 9/30/91 11/27/91 120-14-9 Benzaldehyde, 3,4-dimethoxy-...... 9/30/91 11/27/91 120-21-8 Benzaldehyde, 4-(diethylamino)-...... 9/30/91 11/27/91 120-57-0 1,3-Benzodioxole-5-carboxaldehyde ...... 9/30/91 11/27/91 121-32-4 Benzaldehyde, 3-ethoxy-4-hydroxy-...... 9/30/91 11/27/91 121-33-5 Benzaldehyde, 4-hydroxy-3-methoxy-...... 9/30/91 11/27/91 122-40-7 Heptanal, 2-(phenylmethylene)-...... 9/30/91 11/27/91 122-78-1 Benzeneacetaldehyde ...... 9/30/91 11/27/91 123-05-7 Hexanal, 2-ethyl-...... 9/30/91 11/27/91 123-08-0 Benzaldehyde, 4-hydroxy-...... 9/30/91 11/27/91 123-11-5 Benzaldehyde, 4-methoxy-...... 9/30/91 11/27/91 123-38-6 Propanal ...... 9/30/91 11/27/91 124-13-0 Octanal ...... 9/30/91 11/27/91 124-19-6 Nonanal ...... 9/30/91 11/27/91 126-15-8 4a(4H)-Dibenzofurancarboxaldehyde, 1,5a,6,9,9a,9b-hexahydro-...... 9/30/91 11/27/91 135-02-4 Benzaldehyde, 2-methoxy-...... 9/30/91 11/27/91 141-27-5 2,6-Octadienal, 3,7-dimethyl-, (E)- ...... 9/30/91 11/27/91 143-14-6 9-Undecenal ...... 9/30/91 11/27/91 455-19-6 Benzaldehyde, 4-(trifluoromethyl)-...... 9/30/91 11/27/91 505-57-7 02-Hexenal ...... 9/30/91 11/27/91 552-89-6 Benzaldehyde, 2-nitro-...... 9/30/91 11/27/91 590-86-3 Butanal, 3-methyl-...... 9/30/91 11/27/91 597-31-9 Propanal, 3-hydroxy-2,2-dimethyl-...... 9/30/91 11/27/91 939-97-9 Benzaldehyde, 4-(1,1-dimethylethyl)-...... 9/30/91 11/27/91 1121-60-4 2-Pyridinecarboxaldehyde ...... 9/30/91 11/27/91 1200-14-2 Benzaldehyde, 4-butyl...... 9/30/91 11/27/91 1331-92-6 2-Propenal, 3-phenyl-, monopentyl deriv...... 9/30/91 11/27/91 1334-78-7 Benzaldehyde, methyl-...... 9/30/91 11/27/91 1423-46-7 3-Cyclohexene-1-carboxaldehyde, 2,4,6-trimethyl-...... 9/30/91 11/27/91 1504-74-1 2-Propenal, 3-(2-methoxyphenyl)-...... 9/30/91 11/27/91 2591-86-8 1-Piperidinecarboxaldehyde ...... 9/30/91 11/27/91 3132-99-8 Benzaldehyde, 3-bromo-...... 9/30/91 11/27/91 3268-49-3 Propanal, 3-(methylthio)-...... 9/30/91 11/27/91 3613-30-7 Octanal, 7-methoxy-3,7-dimethyl-...... 9/30/91 11/27/91 4501-58-0 3-Cyclopentene-1-acetaldehyde, 2,2,3-trimethyl-...... 9/30/91 11/27/91 5435-64-3 Hexanal, 3,5,5-trimethyl-...... 9/30/91 11/27/91 5780-07-4 1,3-Benzodioxole-5-carboxaldehyde, 7-methoxy-...... 9/30/91 11/27/91 5949-05-3 6-Octenal, 3,7-dimethyl-, (S)- ...... 9/30/91 11/27/91 5988-91-0 Octanal, 3,7-dimethyl-...... 9/30/91 11/27/91 10031-82-0 Benzaldehyde, 4-ethoxy-...... 9/30/91 11/27/91 13586-68-0 2-Propenal, 3- 4-(1,1-dimethylethyl)phenyl-2-methyl- ...... 9/30/91 11/27/91 17754-90-4 Benzaldehyde, 4-(diethylamino)-2-hydroxy-...... 9/30/91 11/27/91 26266-68-2 Hexenal, 2-ethyl-...... 9/30/91 11/27/91 27939-60-2 3-Cyclohexene-1-carboxaldehyde, dimethyl-...... 9/30/91 11/27/91 28602-27-9 Benzaldehyde, (dimethylamino)-...... 9/30/91 11/27/91 31906-04-4 3-Cyclohexene-1-carboxaldehyde, 4-(4-hydroxy-4-methylpentyl)-...... 9/30/91 11/27/91 37677-14-8 3-Cyclohexene-1-carboxaldehyde, 4-(4-methyl-3-pentenyl)-...... 9/30/91 11/27/91 39515-51-0 Benzaldehyde, 3-phenoxy-...... 9/30/91 11/27/91 52475-86-2 3-Cyclohexene-1-carboxaldehyde, 1-methyl-4-(4-methyl-3-pentenyl)-...... 9/30/91 11/27/91 66327-54-6 3-Cyclohexene-1-carboxaldehyde, 1-methyl-4-(4-methylpentyl)-...... 9/30/91 11/27/91

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Effective Reporting CAS No. Substance date date

Aldehydes

Alkyl-, Chloro-, and Hydroxymethyl Diaryl Ethers

3061–36–7 1,4-Diphenoxybenzene ...... 04/12/93 06/10/93 3586–14–9 Benzene, 1-methyl-3-phenoxy-...... 04/12/93 06/10/93 13826–35–2 Benzenemethanol, 3-phenoxy-,...... 04/12/93 06/10/93 28299–41–4 Benzene, 1,1,′-oxybis[methyl- ...... 04/12/93 06/10/93 28984–89–6 1,1′-Biphenyl, phenoxy- ...... 04/12/93 06/10/93 42874–96–4 2-Chloro-1-(3-methylphenoxy)-4-(trifluoromethyl)benzene ...... 04/12/93 06/10/93 50594–77–9 Phenol, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, acetate ...... 04/12/93 06/10/93 50789–44–1 Benzenemethanol, 3-phenoxy-, acetate ...... 04/12/93 06/10/93 51632–16–7 Benzene, 1-(bromomethyl)-3-phenoxy-...... 04/12/93 06/10/93 61702–88–3 Benzene, 1,1′-oxybis[(1,1,3,3-tetramethylbutyl)- ...... 04/12/93 06/10/93 63734–62–3 Benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, ...... 04/12/93 06/10/93 69834–19–1 Benzene, 1,1′-oxybis[dodecyl- ...... 04/12/93 06/10/93 72252–48–3 Benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, potassium salt ...... 04/12/93 06/10/93

Alkylphenols, Alkylphenol ethoxylates, and Polyalkylphenols

80–46–6 4-tert-Pentylphenol ...... 3/29/96 5/29/96 88–18–6 2-tert-Butylphenol ...... 3/29/96 5/29/96 94–06–4 4-(1-Methylbutyl)phenol ...... 3/29/96 5/29/96 98–54–4 4-tert-Butylphenol ...... 3/29/96 5/29/96 99–71–8 4-sec-Butylphenol ...... 3/29/96 5/29/96 104–40–5 4-Nonylphenol ...... 3/29/96 5/29/96 104–43–8 4-Dodecylphenol ...... 3/29/96 5/29/96 136–81–2 Phenol, 2-pentyl-...... 8/4/00 10/3/00 140–66–9 Phenol, 4-(1,1,3,3-tetramethylbutyl)-...... 8/4/00 10/3/00 949–13–3 2-Octylphenol ...... 3/29/96 5/29/96 1300–16–9 Nonylphenol (mixed isomers) ...... 3/29/96 5/29/96 1322–69–6 (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) ...... 3/29/96 5/29/96 1331–57–3 Dodecylphenol (mixed isomers) ...... 3/29/96 5/29/96 1638–22–8 4-n-Butylphenol ...... 3/29/96 5/29/96 1806–26–4 4-Octylphenol ...... 3/29/96 5/29/96 1987–50–4 Phenol, 4-heptyl-...... 8/4/00 10/3/00 2315–66–4 Decaethylene glycol 4-isooctylphenyl ether ...... 3/29/96 5/29/96 2446–69–7 Phenol, 4-hexyl-...... 8/4/00 10/3/00 2497–58–7 Hexaethylene glycol 4-isooctylphenyl ether ...... 3/29/96 5/29/96 2589–78–8 Phenol, 4-hexadecyl-...... 8/4/00 10/3/00 3180–09–4 2-Butylphenol ...... 3/29/96 5/29/96 3279–27–4 Phenol, 2-(1,1-dimethylpropyl)-...... 8/4/00 10/3/00 3884–95–5 2-(1,1,3,3-Tetramethylbutyl)phenol ...... 3/29/96 5/29/96 9002–93–1 Polyethylene glycol 4-(tert-octyl)phenyl ether ...... 3/29/96 5/29/96 9004–87–9 Poly(oxy-1,2-ethanediyl), a-(isooctylphenyl)-w-hydroxy- ...... 8/4/00 10/3/00 9014–92–0 Poly(oxy-1,2-ethanediyl), a-(dodecylphenyl)-w-hydroxy- ...... 8/4/00 10/3/00 9036–19–5 Polyethylene glycol mono(octyl)phenyl ether ...... 3/29/96 5/29/96 9063–89–2 Poly(oxy-1,2-ethanediyl), a-(octylphenyl)-w-hydroxy- ...... 8/4/00 10/3/00 11066–49–2 Isononylphenol (mixed isomers) ...... 3/29/96 5/29/96 14938–35–3 4-Pentylphenol ...... 3/29/96 5/29/96 17404–66–9 4-(1-Methyloctyl)phenol ...... 3/29/96 5/29/96 25154–52–3 Nonylphenol (mixed isomers) ...... 3/29/96 5/29/96 25401–86–9 Phenol, 2-hexadecyl-...... 8/4/00 10/3/00 25735–67–5 Phenol, 4-sec-pentyl-...... 8/4/00 10/3/00 26401–47–8 Poly(oxy-1,2-ethanediyl), a-(4-dodecylphenyl)-w-hydroxy- ...... 8/4/00 10/3/00 26401–74–1 Phenol, 2-sec-pentyl-...... 8/4/00 10/3/00 27157–66–0 Phenol, decyl-...... 8/4/00 10/3/00 27178–34–3 tert-Butylphenol (mixed isomers) ...... 3/29/96 5/29/96 27193–28–8 (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) ...... 3/29/96 5/29/96 27193–86–8 Dodecylphenol (mixed isomers) ...... 3/29/96 5/29/96 27985–70–2 (1-Methylheptyl)phenol (mixed isomers) ...... 3/29/96 5/29/96 29932–96–5 (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) ...... 3/29/96 5/29/96 30105–54–5 (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) ...... 3/29/96 5/29/96 31195–95–6 Isobutylphenol (mixed isomers) ...... 3/29/96 5/29/96 54932–78–4 4-(2,2,3,3-Tetramethylbutyl)phenol ...... 3/29/96 5/29/96 59911–95–4 Poly(oxy-1,2-ethanediyl), a-(4-hexadecylphenyl)-w-hydroxy- ...... 8/4/00 10/3/00 61723–87–3 Poly(oxy-1,2-ethanediyl), a-(tridecylphenyl)-w-hydroxy- ...... 8/4/00 10/3/00 62744–41–6 (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) ...... 3/29/96 5/29/96 68081–86–7 Phenol, nonyl derivs...... 8/4/00 10/3/00 68784–24–7 Phenol, C18–30-alkyl derivs...... 8/4/00 10/3/00 68891–67–8 Phenol, polypropene derivs...... 8/4/00 10/3/00 68908–55–4 Phenol, polybutene derivs...... 8/4/00 10/3/00 68954–70–1 Phenol, polyethyl derivs...... 8/4/00 10/3/00

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Effective Reporting CAS No. Substance date date

Alkylphenols, Alkylphenol ethoxylates, and Polyalkylphenols

68987–90–6 Poly(oxy-1,2-ethanediyl), a-(octylphenyl)-w-hydroxy-, branched ...... 3/29/96 5/29/96 70682–80–3 Phenol, tetradecyl-...... 8/4/00 10/3/00 71902–25–5 Phenol, octenylated...... 8/4/00 10/3/00 72624–02–3 Phenol, heptyl derivs...... 8/4/00 10/3/00 74499–35–7 Phenol, (tetrapropenyl) derivs...... 8/4/00 10/3/00 84605–25–4 Phenol, 1-methylhexyl derivs...... 8/4/00 10/3/00 84852–15–3 Branched 4-nonylphenol (mixed isomers) ...... 3/29/96 5/29/96 91672–41–2 Phenol, 2-nonyl-, branched ...... 8/4/00 10/3/00 112375–88–9 Phenol, polyisobutylene derivs...... 8/4/00 10/3/00 112375–89–0 Phenol, poly(2,4,4-trimethylpentene) derivs ...... 8/4/00 10/3/00

Alkyl phosphates

78–40–0 Phosphoric acid, triethyl ester ...... 10/29/90 12/27/90 78–42–2 Phosphoric acid, tris(2-ethylhexyl)ester ...... 10/29/90 12/27/90 78–51–3 Ethanol, 2-butoxy-, phosphate (3:1) ...... 10/29/90 12/27/90 107–66–4 Phosphoric acid, dibutyl ester ...... 10/29/90 12/27/90 126–71–6 Phosphoric acid, tris(2-methylpropyl) ester ...... 10/29/90 12/27/90 126–73–8 Phosphoric acid tributyl ester ...... 10/29/90 12/27/90 298–07–7 Phosphoric acid, bis(2-ethylhexyl)ester ...... 10/29/90 12/27/90 812–00–0 Phosphoric acid, monomethyl ester ...... 10/29/90 12/27/90 1070–03–7 Phosphoric acid, mono(2-ethylhexyl)ester ...... 10/29/90 12/27/90 1498–51–7 Phosphorodichloridic acid, ethylester ...... 10/29/90 12/27/90 1623–15–0 Phosphoric acid, monobutyl ester ...... 10/29/90 12/27/90 1623–24–1 Phosphoric acid, mono(1-methylethyl)ester ...... 10/29/90 12/27/90 2958–09–0 Phosphoric acid, monooctadecyl ester ...... 10/29/90 12/27/90 3900–04–7 Phosphoric acid, monohexyl ester ...... 10/29/90 12/27/90 3991–73–9 Phosphoric acid, monooctyl ester ...... 10/29/90 12/27/90 7057–92–3 Phosphoric acid, didodecyl ester ...... 10/29/90 12/27/90 7332–46–9 Ethanol, 2-(2-butoxyethoxy)-, phosphate (3:1) ...... 10/29/90 12/27/90 12645–31–7 Phosphoric acid, 2-ethylhexyl ester ...... 10/29/90 12/27/90 12751–23–4 Phosphoric acid, dodecyl ester ...... 10/29/90 12/27/90 27215–10–7 Phosphoric acid, diisooctyl ester ...... 10/29/90 12/27/90

Brominated flame retardants

87–10–5 Benzamide, 3,5-dibromo-N-(4-bromophenyl)-2-hydroxy-...... 10/29/90 12/27/90 87–83–2 Benzene, pentabromomethyl-...... 10/29/90 12/27/90 87–84–3 Cyclohexane,1,2,3,4,5-pentabromo-6-chloro- ...... 10/29/90 12/27/90 96–13–9 1-Propanol, 2,3-dibromo-...... 10/29/90 12/27/90 593–60–2 Ethene, bromo-...... 10/29/90 12/27/90 615–58–7 Phenol, 2,4-dibromo-...... 10/29/90 12/27/90 4162–45–2 Ethanol,2,2′-((1-methylethylidene)bis((2,6-dibromo-4,1-phenylene)oxy))bis- ...... 10/29/90 12/27/90 25327–89–3 Benzene, 1,1′-(1-methylethylidene)bis(3,5-dibromo-4-(2-propenyloxy)- ...... 10/29/90 12/27/90 30554–72–4 Cyclohexane, tetrabromodichloro-...... 10/29/90 12/27/90 30554–73–5 Cyclohexane, tribromotrichloro-...... 10/29/90 12/27/90 36483–57–5 1-Propanol, 2,2-dimethyl-, tribromo deriv...... 10/29/90 12/27/90 55205–38–4 2-Propenoic acid, (1-methylethylidene)bis(2,6-dibromo-4,1-phenylene) ester ...... 10/29/90 12/27/90 68955–41–9 Alkanes, C10-18, bromochloro- ...... 10/29/90 12/27/90 69882–11–7 Phenol, 2,4(or 2,6)-dibromo-, homopolymer ...... 10/29/90 12/27/90 88497–56–7 Benzene, ethenyl-, homopolymer, brominated ...... 10/29/90 12/27/90

Chloralkyl phosphates

34621–99–3 1,2-Ethanediyltetrakis(2-chloro-1-methylethylene) phosphate...... 6/14/93 8/12/93 38051–10–4 2,2-Bis(chloromethyl)-1,3-propanediyltetrakis(2-chloroethyl) phosphate...... 6/14/93 8/12/93 53461–82–8 Oxydi-2,1-ethanediyltetrakis(2-chloroethyl) phosphate...... 6/14/93 8/12/93 76649–15–5 2-Chloro-1-methylethylbis(2-chloropropyl) phosphate.

Cyanoacrylates

137–05–3 2-Propenoic acid, 2-cyano-, methyl ester ...... 1/26/94 3/28/94 1069–55–2 2-Propenoic acid, 2-cyano-, isobutyl ester ...... 1/26/94 3/28/94 6197–30–4 2-Propenoic acid, 2-cyano-3,3-diphenyl-, 2-ethylhexyl ester ...... 1/26/94 3/28/94 6606–65–1 2-Propenoic acid, 2-cyano-, butyl ester ...... 1/26/94 3/28/94 7085–85–0 2-Propenoic acid, 2-cyano-, ethyl ester ...... 1/26/94 3/28/94 7324–02–9 2-Propenoic acid, 2-cyano-, 2-propenyl ester ...... 1/26/94 3/28/94 10586–17–1 2-Propenoic acid, 2-cyano-, 1-methylethyl ester ...... 1/26/94 3/28/94 21982–43–4 2-Propenoic acid, 2-cyano-, ethoxyethyl ester ...... 1/26/94 3/28/94 23023–91–8 2-Propenoic acid, 2-cyano-, 2,2,2-trifluoromethyl ester ...... 1/26/94 3/28/94 27816–23–5 2-Propenoic acid, 2-cyano-, 2-methoxyethyl ester ...... 1/26/94 3/28/94

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Effective Reporting CAS No. Substance date date

Cyanoacrylates

64992–16–1 Ethanaminium, 2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxo-2-propenyl]oxy]-N,N,N- 1/26/94 3/28/94 trimethyl-, chloride.

Indium Chemicals

923–34–2 Triethylindium ...... 8/27/01 10/24/01 1303–11–3 Indium arsenide...... 8/27/01 10/24/01 1312–41–0 Indium antimonide...... 8/27/01 10/24/01 1312–43–2 Indium (III) oxide ...... 8/27/01 10/24/01 1312–45–4 Indium (III) telluride ...... 8/27/01 10/24/01 4194–69–8 Indium (III) citrate ...... 8/27/01 10/24/01 7440–74–6 Indium ...... 8/27/01 10/24/01 7783–52–0 Indium (III) fluoride ...... 8/27/01 10/24/01 10025–82–8 Indium (III) chloride ...... 8/27/01 10/24/01 12018–95–0 Copper indium diselenide ...... 8/27/01 10/24/01 12030–14–7 Indium (II) sulfide ...... 8/27/01 10/24/01 12030–24–9 Indium (III) sulfide ...... 8/27/01 10/24/01 12056–07–4 Indium selenide...... 8/27/01 10/24/01 12672–70–7 Indium chloride...... 8/27/01 10/24/01 12672–71–8 Indium oxide...... 8/27/01 10/24/01 13464–82–9 Indium (III) sulfate ...... 8/27/01 10/24/01 13465–09–3 Indium (III) bromide ...... 8/27/01 10/24/01 13465–10–6 Indium (I) chloride ...... 8/27/01 10/24/01 13510–35–5 Indium (III) iodide ...... 8/27/01 10/24/01 13709–93–8 Indium (III) borate ...... 8/27/01 10/24/01 13770–61–1 Indium (III) nitrate ...... 8/27/01 10/24/01 13966–94–4 Indium (I) iodide ...... 8/27/01 10/24/01 14166–78–0 Indium (III) fluoride ...... 8/27/01 10/24/01 14280–53–6 Indium (I) bromide ...... 8/27/01 10/24/01 14405–45–9 Indium tris(acetylacetonate)...... 8/27/01 10/24/01 20661–21–6 Indium (III) hydroxide ...... 8/27/01 10/24/01 22398–80–7 Indium (I) phosphide ...... 8/27/01 10/24/01 25114–58–3 Indium (III) acetate ...... 8/27/01 10/24/01 25617–98–5 Indium nitride...... 8/27/01 10/24/01 27765–48–6 Indium (III) tetrafluoroborate ...... 8/27/01 10/24/01 50926–11–9 Indium tin oxide ...... 8/27/01 10/24/01 55326–87–9 Indium hydroxide...... 8/27/01 10/24/01 66027–93–8 Indium (III) sulfamate ...... 8/27/01 10/24/01 66027–94–9 Hydroxybis(trifluoroacetato-O)indium ...... 8/27/01 10/24/01 67816–06–2 Indium (III) 2-ethylhexanoate ...... 8/27/01 10/24/01 68310–35–0 Indium (III) neodecanoate ...... 8/27/01 10/24/01 71243–84–0 Indium tin oxide (In1.69Sn0.1502O2.85) ...... 8/27/01 10/24/01

IRIS Chemicals

51-28-5 2,4 Dinitrophenol...... 9/30/91 11/27/91 95-65-8 3,4 Dinethylphenol...... 9/30/91 11/27/91

Isocyanates

91–97–4 1,1′-Biphenyl, 4,4′-diisocyanato-3,3′-dimethyl- ...... 10/29/90 12/27/90 100–28–7 Benzene, 1-isocyanato-4-nitro-...... 10/29/90 12/27/90 101–68–8 Benzene, 1,1′-methylenebis(4-isocyanato- ...... 10/29/90 12/27/90 102–36–3 Benzene, 1,2-dichloro-4-isocyanato-...... 10/29/90 12/27/90 103–71–9 Benzene, isocyanato-...... 10/29/90 12/27/90 104–12–1 Benzene, 1-chloro-4-isocyanato-...... 10/29/90 12/27/90 104–49–4 Benzene, 1,4-diisocyanato-...... 10/29/90 12/27/90 109–90–0 Ethane, isocyanato-...... 10/29/90 12/27/90 110–78–1 Propane, 1-isocyanato-...... 10/29/90 12/27/90 111–36–4 Butane, 1-isocyanato-...... 10/29/90 12/27/90 112–96–9 Octadecane, 1-isocyanato-...... 10/29/90 12/27/90 123–61–5 Benzene, 1,3-diisocyanato-...... 10/29/90 12/27/90 329–01–1 Benzene, 1-isocyanato-3-(trifluoromethyl)-...... 10/29/90 12/27/90 614–68–6 Benzene, 1-isocyanato-2-methyl-...... 10/29/90 12/27/90 622–58–2 Benzene, 1-isocyanato-4-methyl-...... 10/29/90 12/27/90 624–83–9 Methane, isocyanato-...... 10/29/90 12/27/90 1476–23–9 1-Propene, 3-isocyanato-...... 10/29/90 12/27/90 2422–91–5 Benzene, 1,1′,1″-methylidynetris(4-isocyanato- ...... 10/29/90 12/27/90 2493–02–9 Benzene, 1-bromo-4-isocyanato-...... 10/29/90 12/27/90 2909–38–8 Benzene, 1-chloro-3-isocyanato-...... 10/29/90 12/27/90 2949–22–6 Acetic acid, isocyanato-, ethyl ester ...... 10/29/90 12/27/90 3173–53–3 Cyclohexane, isocyanato-...... 10/29/90 12/27/90

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Effective Reporting CAS No. Substance date date

OSHA Chemicals in Need of Dermal Absorption Testing

4035–89–6 Imidodicarbonic diamide,N,N′,2-tris(6-isocyanatohexyl)- ...... 10/29/90 12/27/90 4098–71–9 Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-...... 10/29/90 12/27/90 4151–51–3 Phenol, 4-isocyanato-, phosphorothioate (3:1) (ester) ...... 10/29/90 12/27/90 5124–30–1 Cyclohexane, 1,1′-methylenebis(4-isocyanato- ...... 10/29/90 12/27/90 5873–54–1 Benzene, 1-isocyanato-2-((4-isocyanatophenyl)methyl)-...... 10/29/90 12/27/90 10031–75–1 Benzene, 1,1′-(diisocyanatomethylene)bis- ...... 10/29/90 12/27/90 15646–96–5 Hexane, 1,6-diisocyanato-2,4,4-trimethyl-...... 10/29/90 12/27/90 16938–22–0 Hexane, 1,6-diisocyanato-2,2,4-trimethyl-...... 10/29/90 12/27/90 25854–16–4 Benzene, bis(isocyanatomethyl)-...... 10/29/90 12/27/90 26447–40–5 Benzene, 1,1′-methylenebis(isocyanato- ...... 10/29/90 12/27/90 26603–40–7 1,3,5,-Triazine-2,4,6(1H.3H,5H-trione, 1,3,5-tris(3-isocyanatomethylphenyl)-...... 10/29/90 12/27/90 26747–90–0 1,3-Diazetidine-2,4-dione, 1,3-bis(3-isocyanatomethylphenyl)-...... 10/29/90 12/27/90 28178–42–9 Benzene, 2-isocyanato-1,3-bis(1-methylethyl)-...... 10/29/90 12/27/90 28556–81–2 Benzene, 2-isocyanato-1,3-dimethyl-...... 10/29/90 12/27/90 30674–80–7 2-Propenoic acid, 2-methyl-,2-isocyanatoethyl ester ...... 10/29/90 12/27/90 34893–92–0 Benzene, 1,3-dichloro-5-isocyanato-...... 10/29/90 12/27/90 68239–06–5 Cyclohexane, 2-heptyl-3,4-bis(9-isocyanatononyl)-1-pentyl-...... 10/29/90 12/27/90 73597–26–9 2-Propenoic acid, 2-methyl-, 2-(((((5-isocyanato-1,3,3-trimethylcyclohexyl) meth- 10/29/90 12/27/90 yl)amino)carbonyl)oxy)ethyl ester.

Methyl ethylene glycol ethers and esters

3121-61-7 Ethylene glycol monomethyl ether acrylate ...... 1/26/94 3/28/94 23783-42-8 Tetraethylene glycol monomethyl ether ...... 1/26/94 3/28/94

Nonylphenol ethoxylates

7311–27–5 Ethanol, 2-[2-[2-[2-(p-nonylphenoxy)ethoxy]ethoxy]ethoxy]-...... 2/10/00 4/10/00 9016–45–9 Poly(oxy-1,2-ethanediyl), alpha-(nonylphenyl)-omega-hydroxy-...... 2/10/00 4/10/00 20427–84–3 Ethanol, 2-[2-(p-nonylphenoxy)ethoxy]-...... 2/10/00 4/10/00 20636–48–0 3,6,9,12-Tetraoxatetradecan-1-ol, 14-(4-nonylphenoxy)-...... 2/10/00 4/10/00 26027–38–3 Poly(oxy-1,2-ethanediyl), alpha-(4-nonylphenyl)-omega-hydroxy-...... 2/10/00 4/10/00 26264–02–8 3,6,9,12-Tetraoxatetradecan-1-ol, 14-(nonylphenoxy)-...... 2/10/00 4/10/00 26571–11–9 3,6,9,12,15,18,21,24-Octaoxahexacosan-1-ol, 26-(nonylphenoxy)-...... 2/10/00 4/10/00 27176–93–8 Ethanol, 2-[2-(nonylphenoxy)ethoxy]-...... 2/10/00 4/10/00 27177–01–1 3,6,9,12,15-Pentaoxaheptadecan-1-ol, 17-(nonylphenoxy)-...... 2/10/00 4/10/00 27177–05–5 3,6,9,12,15,18,21-Heptaoxatricosan-1-ol, 23-(nonylphenoxy)-...... 2/10/00 4/10/00 27177–08–8 3,6,9,12,15,18,21,24,27-Nonaoxanonacosan-1-ol, 29-(nonylphenoxy)-...... 2/10/00 4/10/00 27986–36–3 Ethanol, 2-(nonylphenoxy)-...... 2/10/00 4/10/00 37205–87–1 Poly(oxy-1,2-ethanediyl), alpha-(isononylphenyl)-omega-hydroxy-...... 2/10/00 4/10/00 51938–25–1 Poly(oxy-1,2-ethanediyl), alpha-(2-nonylphenyl)-omega-hydroxy-...... 2/10/00 4/10/00 65455–72–3 3,6,9,12,15,18,21,24,27-Nonaoxanonacosan-1-ol, 29-(isononylphenoxy)-...... 2/10/00 4/10/00 68412–54–4 Poly(oxy-1,2-ethanediyl), alpha-(nonylphenyl)-omega-hydroxy-, branched ...... 2/10/00 4/10/00 98113–10–1 NP9 ...... 2/10/00 4/10/00 127087–87–0 Poly(oxy-1,2-ethanediyl), alpha-(4-nonylphenyl)-omega-hydroxy-, branched ...... 2/10/00 4/10/00 152143–22–1 Poly(oxy-1,2-ethanediyl), alpha-(4-nonylphenyl)-omega-hydroxy-, branched, 2/10/00 4/10/00 phosphates.

OSHA Chemicals in Need of Dermal Absorption Testing

60–29–7 Ethyl ether...... 1/26/94 3/28/94 61–82–5 Amitrole ...... 3/11/94 5/10/94 74–96–4 Ethyl bromide...... 3/11/94 5/10/94 75–05–8 Acetonitrile ...... 8/4/95 10/3/95 75–12–7 Formamide ...... 8/4/95 10/3/95 75–15–0 Carbon disulfide...... 3/11/94 5/10/94 75–25–2 Bromoform ...... 3/11/94 5/10/94 75–34–3 1,1–Dichloroethane ...... 3/11/94 5/10/94 75–35–4 Vinylidene chloride...... 8/4/95 10/3/95 75–65–0 tert-Butyl alcohol ...... 1/26/94 3/28/94 76–22–2 Camphor ...... 1/26/94 3/28/94 77–73–6 Dicyclopentadiene ...... 8/4/95 10/3/95 77–78–1 Dimethyl sulfate...... 3/11/94 5/10/94 78–59–1 Isophorone ...... 8/4/95 10/3/95 78-87-5 Propylene dichloride...... 8/4/95 10/3/95 78–92–2 sec-Butyl alcohol ...... 1/26/94 3/28/94 79–20–9 Methyl acetate...... 1/26/94 3/28/94 79–46–9 2–Nitropropane ...... 3/11/94 5/10/94 88-72-2 o-Nitrotoluene ...... 3/11/94 5/10/94 89-72-5 o-sec-Butylphenol ...... 3/11/94 5/10/94 90-04-0 o-Anisidine ...... 3/11/94 5/10/94 91-20-3 Naphthalene ...... 8/4/95 10/3/95

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Effective Reporting CAS No. Substance date date

OSHA Chemicals in Need of Dermal Absorption Testing

92-52-4 Biphenyl ...... 8/4/95 10/3/95 95-13-6 Indene ...... 3/11/94 5/10/94 95-49-8 o-Chlorotoluene ...... 3/11/94 5/10/94 95-50-1 o-Dichlorobenzene ...... 8/4/95 10/3/95 96-18-4 1,2,3-Trichloropropane ...... 8/4/95 10/3/95 97–77–8 Disulfiram ...... 1/26/94 3/28/94 98-29-3 t-Butylcatechol ...... 8/4/95 10/3/95 99-08-1 m-Nitrotoluene ...... 8/4/95 10/3/95 99-65-0 m-Dinitrobenzene ...... 3/11/94 5/10/94 99-99-0 p-Nitrotoluene ...... 8/4/95 10/3/95 100-00-5 p-Nitrochlorobenzene ...... 3/11/94 5/10/94 100-01-6 p-Nitroaniline ...... 3/11/94 5/10/94 100-44-7 Benzyl chloride...... 3/11/94 5/10/94 100–25–4 p-Dinitrobenzene ...... 1/26/94 3/28/94 100-63-0 Phenylhydrazine ...... 3/11/94 5/10/94 105–46–4 sec-Butyl acetate ...... 1/26/94 3/28/94 106–42–3 p-Xylene ...... 1/26/94 3/28/94 106-46-7 p-Dichlorobenzene ...... 8/4/95 10/3/95 106-49-0 p-Toluidine ...... 3/11/94 5/10/94 107-06-2 Ethylene dichloride...... 8/4/95 10/3/95 107–31–3 Methyl formate...... 1/26/94 3/28/94 107–66–4 Dibutyl phosphate...... 1/26/94 3/28/94 108–03–2 1-Nitropropane ...... 1/26/94 3/28/94 108-44-1 m-Toluidine ...... 3/11/94 5/10/94 108–87–2 Methylcyclohexane ...... 1/26/94 3/28/94 108-90-7 Chlorobenzene ...... 3/11/94 5/10/94 108-93-0 Cyclohexanol ...... 8/4/95 10/3/95 109–66–0 Pentane ...... 1/26/94 3/28/94 109-99-9 Tetrahydrofuran ...... 3/11/94 5/10/94 110-12-3 Methyl isoamyl ketone ...... 8/4/95 10/3/95 110–83–8 Cyclohexene ...... 1/26/94 3/28/94 111–84–2 Nonane ...... 1/26/94 3/28/94 120-80-9 Catechol ...... 8/4/95 10/3/95 121-14-2 2,4-Dinitrotoluene ...... 3/11/94 5/10/94 121-69-7 Dimethylaniline ...... 8/4/95 10/3/95 122-39-4 Diphenylamine ...... 3/11/94 5/10/94 123-42-2 Diacetone alcohol...... 8/4/95 10/3/95 123–92–2 Isoamyl acetate...... 1/26/94 3/28/94 126-99-8 beta-Chloroprene ...... 3/11/94 5/10/94 127-19-5 Dimethyl acetamide...... 8/4/95 10/3/95 142–82–5 Heptane (n-Heptane) ...... 1/26/94 3/28/94 150-76-5 p-Methoxyphenol ...... 3/11/94 5/10/94 287–92–3 Cyclopentane ...... 1/26/94 3/28/94 528-29-0 o-Dinitrobenzene ...... 3/11/94 5/10/94 532–27–4 a-Chloroacetophenone ...... 1/26/94 3/28/94 540-59-0 1,2-Dichloroethylene ...... 3/11/94 5/10/94 540–88–5 tert-Butyl acetate ...... 1/26/94 3/28/94 542-92-7 Cyclopentadiene ...... 8/4/95 10/3/95 626-17-5 m-Phthalodinitrile ...... 3/11/94 5/10/94 628–63–7 n-Amyl acetate ...... 1/26/94 3/28/94 768-52-5 N-Isopropylaniline ...... 3/11/94 5/10/94 1300-73-8 Xylidine ...... 3/11/94 5/10/94 6423-43-4 Propylene glycol dinitrate ...... 3/11/94 5/10/94 7631–90–5 Sodium bisulfite...... 1/26/94 3/28/94 7681–57–4 Sodium metabisulfite...... 1/26/94 3/28/94 25013-15-4 Vinyl toluene...... 3/11/94 5/10/94 34590-94-8 Dipropylene glycol methyl ether ...... 8/4/95 10/3/95

Propylene glycol ethers and esters

108–65–6 Propylene glycol monomethyl ether acetate ...... 1/26/94 3/28/94 110–98–5 Dipropylene glycol...... 1/26/94 3/28/94 770–35–4 1–Phenoxy-2-propanol ...... 1/26/94 3/28/94 20324–32–7 1–(2-Methoxy-1-methylethoxy)-2-propanol ...... 1/26/94 3/28/94 20324–33–8 Tripropylene glycol methyl ether ...... 1/26/94 3/28/94 28677–93–2 Methoxy-1-propanol ...... 1/26/94 3/28/94 29387–86–8 Propylene glycol monobutyl ether ...... 1/26/94 3/28/94 29911–28–2 Dipropylene glycol butyl ether ...... 1/26/94 3/28/94 42978–66–5 Tripropylene glycol diacrylate ...... 1/26/94 3/28/94 57018–52–7 Propylene glycol mono-tert-butyl ether ...... 1/26/94 3/28/94 88917–22–0 Dipropylene glycol monomethyl ether acetate ...... 1/26/94 3/28/94

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Effective Reporting CAS No. Substance date date

Propylene glycol ethers and esters

Pyridinamines

462–08–8 3-Pyridinamine ...... 1/6/05 3/7/05 504–24–5 4-Pyridinamine ...... 1/6/05 3/7/05 504–29–0 2-Pyridinamine ...... 1/6/05 3/7/05

Siloxanes

107–46–0 Hexamethyldisiloxane ...... 10/12/93 2/28/94 107–50–6 Tetradecamethylcycloheptasiloxane ...... 10/12/93 2/28/94 107–51–7 Octamethyltrisiloxane ...... 10/12/93 2/28/94 107–52–8 Tetradecamethylhexasiloxane ...... 10/12/93 2/28/94 107–53–9 Tetracosamethylundecasiloxane ...... 10/12/93 2/28/94 141–62–8 Decamethyltetrasiloxane ...... 10/12/93 2/28/94 141–63–9 Dodecamethylpentasiloxane ...... 10/12/93 2/28/94 540–97–6 Dodecamethylcyclohexasiloxane ...... 10/12/93 2/28/94 541–01–5 Hexadecamethylheptasiloxane ...... 10/12/93 2/28/94 541–02–6 Decamethylcyclopentasiloxane ...... 10/12/93 2/28/94 541–05–9 Hexamethylcyclotrisiloxane ...... 10/12/93 2/28/94 546–56–5 Octaphenylcyclotetrasiloxane ...... 10/12/93 2/28/94 556–67–2 Octamethylcyclotetrasiloxane ...... 10/12/93 2/28/94 556–68–3 Hexadecamethylcyclooctasiloxane ...... 10/12/93 2/28/94 556–69–4 Octadecamethyloctasiloxane ...... 10/12/93 2/28/94 556–70–7 Docosamethyldecasiloxane ...... 10/12/93 2/28/94 556–71–8 Octadecamethylcyclononasiloxane ...... 10/12/93 2/28/94 999–97–3 Hexamethyldisilazane ...... 10/12/93 2/28/94 2370–88–9 Tetramethylcyclotetrasiloxane ...... 10/12/93 2/28/94 2374–14–3 Trifluoropropylmethylcyclotrisiloxane ...... 10/12/93 2/28/94 2471–08–1 Hexacosamethyldodecasiloxane ...... 10/12/93 2/28/94 2471–09–2 Octacosamethyltridecasiloxane ...... 10/12/93 2/28/94 2471–10–5 Triacontamethyltetradecasiloxane ...... 10/12/93 2/28/94 2471–11–6 Dotriacontamethylpentadecasiloxane ...... 10/12/93 2/28/94 2554–06–5 Methylvinylcyclosiloxane ...... 10/12/93 2/28/94 2627–95–4 Tetramethyldivinyldisiloxane ...... 10/12/93 2/28/94 2652–13–3 Eicosamethylnonasiloxane ...... 10/12/93 2/28/94 70131-67-8 Siloxanes and silicones, di-Me, hydroxy-terminated ...... 10/12/93 2/28/94 9004–73–3 Methylpolysiloxane ...... 10/12/93 2/28/94 18766–38–6 Docosamethylcycloundecasiloxane ...... 10/12/93 2/28/94 18772–36–6 Eicosamethylcyclodecasiloxane ...... 10/12/93 2/28/94 18844–04–7 Hexatriacontamethylheptadecasiloxane ...... 10/12/93 2/28/94 18919–94–3 Tetracosamethylcyclododecasiloxane ...... 10/12/93 2/28/94 23523–12–8 Hexatriacontamethylcyclooctadecasiloxane ...... 10/12/93 2/28/94 23523–14–0 Triacontamethylcyclopentadecasiloxane ...... 10/12/93 2/28/94 23732–94–7 Hexacosamethylcyclotridecasiloxane ...... 10/12/93 2/28/94 36938–50–8 Tetratriacontamethyl hexadecasiloxane...... 10/12/93 2/28/94 36938–52–0 Octatriacontamethyl octadecasiloxane...... 10/12/93 2/28/94 63148–62–9 Dimethyl silicones and siloxanes ...... 10/12/93 2/28/94 67762–90–7 Dimethyl silicones and siloxane, reaction products with silica ...... 10/12/93 2/28/94 67762–94–1 Dimethylmethylvinylsiloxane ...... 10/12/93 2/28/94 68037–59–2 Dimethylhydropolylsiloxane ...... 10/12/93 2/28/94 68037–74–1 Dimethylpolysiloxanes ...... 10/12/93 2/28/94 68083–14–7 Dimethyldiphenylsiloxane ...... 10/12/93 2/28/94 69430–24–6 Cyclopolydimethylsiloxane ...... 10/12/93 2/28/94 115361-68-7 Dimethylmethyl 3,3,3-trifluoropropyl siloxane ...... 10/12/93 2/28/94 149050-40-8 Octacosamethylcyclotetradecasiloxane ...... 10/12/93 2/28/94 150026–95–2 Dotriacontamethylcyclohexadecasiloxane ...... 10/12/93 2/28/94 150026–96–3 Tetratriacontamethylcycloheptadecasiloxane ...... 10/12/93 2/28/94 150026–97–4 Octatriacontamethylcyclononadecasiloxane ...... 10/12/93 2/28/94 150026–98–5 Tetracontamethylcycloeicosasiloxane ...... 10/12/93 2/28/94 150026-99-6 Tetracontamethylnonadecasiloxane ...... 10/12/93 2/28/94 150027–00–2 Dotetracontamethyleicosasiloxane ...... 10/12/93 2/28/94 not available Polymethyloctadecylsiloxane ...... 10/12/93 2/28/94

Substantially produced chemicals in need of subchronic tests

80-51-3 p,p′-Oxybis(benzenesulfonylhydrazide) ...... 9/30/91 11/27/91 81-84-5 Naphthalenedicarboxylic anhydride...... 9/30/91 11/27/91 84-51-5 2-Ethylanthraquinone ...... 9/30/91 11/27/91 87-02-5 7-Amino-4-hydroxy-2-naphthalenesulfonic acid...... 9/30/91 11/27/91 90-15-3 1-Naphthol ...... 9/30/91 11/27/91 92-70-6 3-Hydroxy-2-naphthoic acid...... 9/30/91 11/27/91 94-28-0 Triethylene glycol bis(2-ethylhexanoate) ...... 9/30/91 11/27/91

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Effective Reporting CAS No. Substance date date

Substantially produced chemicals in need of subchronic tests

95-32-9 2-(4-Morpholinyldithio)-benzothiazole ...... 9/30/91 11/27/91 97-88-1 N-Butyl methacrylate...... 9/30/91 11/27/91 98-48-6 1,3-Benzenedisulfonic Acid...... 9/30/91 11/27/91 99-54-7 3,4-Dichloronitrobenzene ...... 9/30/91 11/27/91 99-63-8 Isophthaloyl chloride...... 9/30/91 11/27/91 100-20-9 Terephthaloyl chloride...... 9/30/91 11/27/91 100-29-8 4-Ethoxynitrobenzene ...... 9/30/91 11/27/91 102-01-2 Acetoacetanilide ...... 9/30/91 11/27/91 106-31-0 Butyric anhydride...... 9/30/91 11/27/91 106-63-8 Isobutyl acrylate...... 9/30/91 11/27/91 111-96-6 Diethylene glycol dimethyl ether ...... 9/30/91 11/27/91 112–15–2 Ethanol, 2-(2-ethoxyethoxy)-, acetate ...... 9/30/91 11/27/91 116-81-4 Bromamine acid...... 9/30/91 11/27/91 119-33-5 4-Methyl-2-nitro-phenol ...... 9/30/91 11/27/91 121-60-8 4-(Acetylamino)benzenesulfonyl chloride...... 9/30/91 11/27/91 123-54-6 2,4-Pentanedione ...... 9/30/91 11/27/91 123-62-6 Propanoic anhydride...... 9/30/91 11/27/91 142-16-5 Bis(2-ethylhexyl)-2-butenedioate ...... 9/30/91 11/27/91 311-89-7 Perfluorotributylamine ...... 9/30/91 11/27/91 355-42-0 Perfluoro-N-hexane ...... 9/30/91 11/27/91 594-42-3 Trichloromethanesulfenyl chloride...... 9/30/91 11/27/91 616-21-7 1,2-Dichlorobutane ...... 9/30/91 11/27/91 626-17-5 1,3-Dicyanobenzene ...... 9/30/91 11/27/91 760-23-6 3,4-Dichlorobutene ...... 9/30/91 11/27/91 929–06–6 2-(2-Aminoethoxy)-ethanol ...... 6/30/92 9/28/92 1047-16-1 Quinacridone ...... 9/30/91 11/27/91 1111-78-0 Ammonium carbamate...... 9/30/91 11/27/91 3089-11-0 Hexa(methoxymethyl) melamine...... 9/30/91 11/27/91

Sulphones

67-71-0 Dimethylsulfone ...... 9/30/91 11/27/91 77–79–2 3-Sulfolene ...... 9/30/91 11/27/91 80-07-9 Sulfonyl bis-(4-chlorobenzene)...... 9/30/91 11/27/91 80-08-0 4,4′-Diaminodiphenyl sulfone ...... 9/30/91 11/27/91 80-09-1 Bisphenol S...... 9/30/91 11/27/91 98-30-6 2-Amino-4-(methylsulfonyl)phenol ...... 9/30/91 11/27/91 126-33-0 Sulfolane ...... 9/30/91 11/27/91 127-63-9 Diphenylsulfone ...... 9/30/91 11/27/91 2580-77-0 2,2′-Sulfonyl bis-ethanol ...... 9/30/91 11/27/91 3278-22-6 1,1′-[Methylene bis(sulfonyl)]bisethene ...... 9/30/91 11/27/91 5246-57-1 2-[(3-Aminophenyl)sulfonyl]ethanol ...... 9/30/91 11/27/91 16588-67-3 3-[N-Ethyl-4-[[6-(methylsulfonyl)-2-benzothiazolyl] azo]-m-toluidino]- propionitrile ..... 9/30/91 11/27/91 17557-67-4 6-(Methylsulfonyl)-2-benzothiazolamine ...... 9/30/91 11/27/91 17601-96-6 2-Amino-4-[(2-hydroxyethyl) sulfonyl]phenol...... 9/30/91 11/27/91 17688-68-5 4-Phenylthiomorpholine, 1,1-dioxide...... 9/30/91 11/27/91 17741-62-7 4-[4-[(2,6-Dichloro-4-nitrophenyl) azo]phenyl]thiomorpholine, 1,1-dioxide- ...... 9/30/91 11/27/91 18760-44-6 3-(Decyloxy)tetrahydrothiophene 1,1-dioxide...... 9/30/91 11/27/91 20018-09-1 1-(Diiodomethyl) sulfonyl-4-methyl benzene ...... 9/30/91 11/27/91 26750-50-5 1,1′-[Oxybis(methylenesulfonyl)] bisethene ...... 9/30/91 11/27/91 36724-43-3 2,2′-[Oxybis(methylenesulfonyl)]bisethanol ...... 9/30/91 11/27/91 41123-59-5 1,1′-[Methylenebis(sulfonyl)]bis-2-chloroethane ...... 9/30/91 11/27/91 41123-69-7 2,2′-[Methylenebis(sulfonyl)]bisethanol ...... 9/30/91 11/27/91 41687-30-3 2-[(3-Nitrophenyl)sulfonyl]ethanol ...... 9/30/91 11/27/91 52218-35-6 2-[(6-Amino-2-naphthalenyl)sulfonyl]ethanol ...... 9/30/91 11/27/91 53061-10-2 1,1′-[Oxybis(methylenesulfonyl)]bis-2-chloroethane ...... 9/30/91 11/27/91 63134-33-8 4-[[4-(Phenylmethoxy)phenyl]sulfonyl]phenol ...... 9/30/91 11/27/91

Tungsten compounds

1314–35–8 Tungsten oxide (WO3) ...... 1/6/05 3/7/05 7440–33–7 Tungsten ...... 1/6/05 3/7/05 2 7783–03–1 Tungstate (WO4 ), dihydrogen, (T-4)- ...... 1/6/05 3/7/05 7783–82–6 Tungsten fluoride (WF6), (OC-6-11)- ...... 1/6/05 3/7/05 2 7790–60–5 Tungstate (WO4 ), dipotassium, (T-4)- ...... 1/6/05 3/7/05 7790–85–4 Cadmium tungsten oxide (CdWO4) ...... 1/6/05 3/7/05 2 10213–10–2 Tungstate (WO4 ), disodium, dihydrate, (T-4)- ...... 1/6/05 3/7/05 11105–11–6 Tungsten oxide (WO3), hydrate ...... 1/6/05 3/7/05 11120–01–7 Sodium tungsten oxide ...... 1/6/05 3/7/05 10 11120–25–5 Tungstate (W12(OH)2O40 ), decaammonium ...... 1/6/05 3/7/05

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Effective Reporting CAS No. Substance date date

Tungsten compounds

12027–38–2 Tungstate(4-),[.mu.12-[orthosilicato(4-)- .kappa.O:.kappa.O:.kappa.O: 1/6/05 3/7/05 .kappa.O’:.kappa.O’:.kappa.O’: .kappa.O′:.kappa.O′ :.kappa.O′ :.kappa.O’′:.kappa.O’′ :.kappa.O’′]]tetracosa- .mu.-oxododecaoxododeca-, tetrahydrogen. 6 12028–48–7 Tungstate (W12(OH)2O38 ), hexaammonium ...... 1/6/05 3/7/05 12036–22–5 Tungsten oxide (WO2) ...... 1/6/05 3/7/05 12067–99–1 Tungsten hydroxide oxide phosphate ...... 1/6/05 3/7/05 12138–09–9 Tungsten sulfide (WS2) ...... 1/6/05 3/7/05 6 12141–67–2 Tungstate (W12(OH)2O38 ), hexasodium ...... 1/6/05 3/7/05 13283–01–7 Tungsten chloride (WCl6), (OC-6-11)- ...... 1/6/05 3/7/05 2 13472–45–2 Tungstate (WO4 ), disodium, (T-4)- ...... 1/6/05 3/7/05 14040–11–0 Tungsten carbonyl (W(CO)6), (OC-6-11)- ...... 1/6/05 3/7/05 23321–70–2 Tungsten oxide (WO3), dihydrate ...... 1/6/05 3/7/05

Vanadium compounds

1314–34–7 Vanadium oxide (V2O3) [Vanadium trioxide] ...... 7/11/03 9/9/03 1314–62–1 Vanadium oxide (V2O5) [Vanadium pentoxide] ...... 7/11/03 9/9/03 1686–22–2 Vanadium, triethoxyoxo-, (T-4)- [Triethyl orthovanadate] ...... 7/11/03 9/9/03 3153–26–2 Vanadium, oxobis (2,4-pentanedionato-.kappa.O,.kappa.O’)-, (SP-5-21)- ...... 7/11/03 9/9/03 5588–84–1 Vanadium, oxotris(2-propanolato)-, (T-4)- [Vanadium triisopropoxide oxide] ...... 7/11/03 9/9/03 7440–62–2 Vanadium ...... 7/11/03 9/9/03 7632–51–1 Vanadium chloride (VCl4), (T-4)- [Vanadium tetrachloride] ...... 7/11/03 9/9/03 7718–98–1 Vanadium chloride (VCl3) [Vanadium trichloride] ...... 7/11/03 9/9/03 7727–18–6 Vanadium, trichlorooxo-, (T-4)- [Vanadium oxytrichloride] ...... 7/11/03 9/9/03 7803–55–6 Vanadate (VO31-), ammonium [Ammonium metavanadate] ...... 7/11/03 9/9/03 10049–16–8 Vanadium fluoride (VF4) [Vanadium tetrafluoride] ...... 7/11/03 9/9/03 10213–09–9 Vanadium, dichlorooxo- [Vanadyl dichloride] ...... 7/11/03 9/9/03 10580–52–6 Vanadium chloride (VCl2) [Vanadium dichloride] ...... 7/11/03 9/9/03 11099–11–9 Vanadium oxide [Polyvanadic acid] ...... 7/11/03 9/9/03 11115–67–6 Ammonium vanadium oxide ...... 7/11/03 9/9/03 11130–21–5 Vanadium carbide...... 7/11/03 9/9/03 12007–37–3 Vanadium boride (VB2) ...... 7/11/03 9/9/03 12035–98–2 Vanadium oxide (VO) ...... 7/11/03 9/9/03 12036–21–4 Vanadium oxide (VO2) ...... 7/11/03 9/9/03 12070–10–9 Vanadium carbide (VC) ...... 7/11/03 9/9/03 12083–48–6 Vanadium, dichlorobis (.eta.5-2,4-cyclopentadien-1-yl)- ...... 7/11/03 9/9/03 12166–27–7 Vanadium sulfide (VS) ...... 7/11/03 9/9/03 12439–96–2 Vanadium, oxo[sulfato(2-)-.kappa.O]-, pentahydrate [Vanadyl sulfate (VOSO4), 7/11/03 9/9/03 pentahydrate]. 12604–58–9 Vanadium alloy, base, V,C,Fe (Ferrovanadium) ...... 7/11/03 9/9/03 13470–26–3 Vanadium bromide (VBr3) ...... 7/11/03 9/9/03 13476–99–8 Vanadium, tris(2,4-pentanedionato-.kappa.O,.kappa.O’)-, (OC-6-11)- [Vanadium 7/11/03 9/9/03 tris(acetylacetonate)]. 13497–94–4 Silver vanadium oxide (AgVO3) ...... 7/11/03 9/9/03 13517–26–5 Sodium vanadium oxide (Na4V2O7) [Sodium pyrovanadate] ...... 7/11/03 9/9/03 13718–26–8 Vanadate (VO31-), sodium [Sodium metavanadate] ...... 7/11/03 9/9/03 13721–39–6 Sodium vanadium oxide (Na3VO4) [Sodium orthovanadate] ...... 7/11/03 9/9/03 13769–43–2 Vanadate (VO31-), potassium [Potassium metavanadate] ...... 7/11/03 9/9/03 13930–88–6 Vanadium, oxo[29H,31H-phthalocyaninato(2-)- 7/11/03 9/9/03 .kappa.N29,.kappa.N30,.kappa.N31,.kappa.N32]-, (SP-5-12)-. 14059–33–7 Bismuth vanadium oxide (BiVO4) ...... 7/11/03 9/9/03 19120–62–8 Vanadium, tris(2-methyl-1-propanolato)oxo-, (T-4)- [Isobutyl orthovanadate] ...... 7/11/03 9/9/03 24646–85–3 Vanadium nitride (VN) ...... 7/11/03 9/9/03 27774–13–6 Vanadium, oxo[sulfato(2-)-.kappa.O]- [Vanadyl sulfate] ...... 7/11/03 9/9/03 30486–37–4 Vanadium hydroxide oxide (V(OH)2O) ...... 7/11/03 9/9/03 39455–80–6 Ammonium sodium vanadium oxide ...... 7/11/03 9/9/03 53801–77–7 Bismuth vanadium oxide ...... 7/11/03 9/9/03 65232–89–5 Vanadium hydroxide oxide phosphate ...... 7/11/03 9/9/03 68130–18–7 Vanadium hydroxide oxide phosphate (V6(OH)3O3(PO4)7) ...... 7/11/03 9/9/03 68815–09–8 Naphthenic acids, vanadium salts ...... 7/11/03 9/9/03 68990–29–4 Balsams, copaiba, sulfurized, vanadium salts ...... 7/11/03 9/9/03

Voluntary HPV Challenge Program orphan (unsponsored) chemicals

62–56–6 Thiourea ...... September November 29, 2006 28, 2006 77–76–9 Propane, 2,2-dimethoxy-...... September November 29, 2006 28, 2006 81–07–2 1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide...... September November 29, 2006 28, 2006

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Voluntary HPV Challenge Program orphan (unsponsored) chemicals

81–16–3 1-Naphthalenesulfonic acid, 2-amino- ...... September November 29, 2006 28, 2006 81–84–5 1H,3H-Naphtho[1,8-cd]pyran-1,3-dione ...... September November 29, 2006 28, 2006 83–41–0 Benzene, 1,2-dimethyl-3-nitro-...... September November 29, 2006 28, 2006 84–69–5 1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester ...... September November 29, 2006 28, 2006 85–40–5 1H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-...... September November 29, 2006 28, 2006 91–68–9 Phenol, 3-(diethylamino)-...... September November 29, 2006 28, 2006 94–96–2 1,3-Hexanediol, 2-ethyl-...... September November 29, 2006 28, 2006 96–22–0 3-Pentanone ...... September November 29, 2006 28, 2006 97–00–7 Benzene, 1-chloro-2,4-dinitro-...... September November 29, 2006 28, 2006 98–09–9 Benzenesulfonyl chloride...... September November 29, 2006 28, 2006 98–16–8 Benzenamine, 3-(trifluoromethyl)-...... September November 29, 2006 28, 2006 98–56–6 Benzene, 1-chloro-4-(trifluoromethyl)-...... September November 29, 2006 28, 2006 101–34–8 9-Octadecenoic acid, 12-(acetyloxy)-, 1,2,3-propanetriyl ester, September November (9Z,9’Z,9’’,12R,12’R,12’’)-. 29, 2006 28, 2006 104–66–5 Benzene, 1,1’-[1,2-ethanediylbis(oxy)]bis-...... September November 29, 2006 28, 2006 104–93–8 Benzene, 1-methoxy-4-methyl-...... September November 29, 2006 28, 2006 107–39–1 1-Pentene, 2,4,4-trimethyl-...... September November 29, 2006 28, 2006 107–40–4 2-Pentene, 2,4,4-trimethyl-...... September November 29, 2006 28, 2006 110–18–9 1,2-Ethanediamine, N,N,N’,N’-tetramethyl-...... September November 29, 2006 28, 2006 110–33–8 Hexanedioic acid, dihexyl ester ...... September November 29, 2006 28, 2006 111–44–4 Ethane, 1,1’-oxybis[2-chloro-...... September November 29, 2006 28, 2006 111–85–3 Octane, 1-chloro-...... September November 29, 2006 28, 2006 111–91–1 Ethane, 1,1’-[methylenebis(oxy)]bis[2-chloro-...... September November 29, 2006 28, 2006 118–90–1 Benzoic acid, 2-methyl- ...... September November 29, 2006 28, 2006 119–33–5 Phenol, 4-methyl-2-nitro-...... September November 29, 2006 28, 2006 121–69–7 Benzenamine, N,N-dimethyl-...... September November 29, 2006 28, 2006 121–82–4 1,3,5-Triazine, hexahydro-1,3,5-trinitro-...... September November 29, 2006 28, 2006 124–63–0 Methanesulfonyl chloride...... September November 29, 2006 28, 2006 127–68–4 Benzenesulfonic acid, 3-nitro-, sodium salt ...... September November 29, 2006 28, 2006 131–57–7 Methanone, (2-hydroxy-4-methoxyphenyl)phenyl-...... September November 29, 2006 28, 2006 137–20–2 Ethanesulfonic acid, 2-[methyl[(9Z)-1-oxo-9-octadecenyl]amino]-, sodium salt ...... September November 29, 2006 28, 2006 138–25–0 1,3-Benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester ...... September November 29, 2006 28, 2006 139–40–2 1,3,5-Triazine-2,4-diamine, 6-chloro-N,N’-bis(1-methylethyl)-...... September November 29, 2006 28, 2006 140–93–2 Carbonodithioic acid, O-(1-methylethyl) ester, sodium salt ...... September November 29, 2006 28, 2006 142–73–4 Glycine, N-(carboxymethyl)-...... September November 29, 2006 28, 2006 330–54–1 Urea, N’-(3,4-dichlorophenyl)-N,N-dimethyl-...... September November 29, 2006 28, 2006

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Voluntary HPV Challenge Program orphan (unsponsored) chemicals

460–00–4 Benzene, 1-bromo-4-fluoro-...... September November 29, 2006 28, 2006 506–51–4 1-Tetracosanol ...... September November 29, 2006 28, 2006 506–52–5 1-Hexacosanol ...... September November 29, 2006 28, 2006 513–74–6 Carbamodithioic acid, monoammonium salt ...... September November 29, 2006 28, 2006 515–40–2 Benzene, (2-chloro-1,1-dimethylethyl)-...... September November 29, 2006 28, 2006 529–33–9 1-Naphthalenol, 1,2,3,4-tetrahydro-...... September November 29, 2006 28, 2006 529–34–0 1(2H)-Naphthalenone, 3,4-dihydro-...... September November 29, 2006 28, 2006 542–92–7 1,3-Cyclopentadiene ...... September November 29, 2006 28, 2006 557–61–9 1-Octacosanol ...... September November 29, 2006 28, 2006 563–72–4 Ethanedioic acid, calcium salt (1:1) ...... September November 29, 2006 28, 2006 590–19–2 1,2-Butadiene ...... September November 29, 2006 28, 2006 592–45–0 1,4-Hexadiene ...... September November 29, 2006 28, 2006 598–72–1 Propanoic acid, 2-bromo- ...... September November 29, 2006 28, 2006 617–94–7 Benzenemethanol, .alpha.,.alpha.-dimethyl-...... September November 29, 2006 28, 2006 628–13–7 Pyridine, hydrochloride...... September November 29, 2006 28, 2006 628–96–6 1,2-Ethanediol, dinitrate...... September November 29, 2006 28, 2006 645–62–5 2-Hexenal, 2-ethyl-...... September November 29, 2006 28, 2006 693–95–8 Thiazole, 4-methyl-...... September November 29, 2006 28, 2006 756–80–9 Phosphorodithioic acid, O,O-dimethyl ester ...... September November 29, 2006 28, 2006 870–72–4 Methanesulfonic acid, hydroxy-, monosodium salt ...... September November 29, 2006 28, 2006 928–72–3 Glycine, N-(carboxymethyl)-, disodium salt ...... September November 29, 2006 28, 2006 939–97–9 Benzaldehyde, 4-(1,1-dimethylethyl)-...... September November 29, 2006 28, 2006 1000–82–4 Urea, (hydroxymethyl)-...... September November 29, 2006 28, 2006 1002–69–3 Decane, 1-chloro-...... September November 29, 2006 28, 2006 1111–78–0 Carbamic acid, monoammonium salt ...... September November 29, 2006 28, 2006 1401–55–4 Tannins ...... September November 29, 2006 28, 2006 1445–45–0 Ethane, 1,1,1-trimethoxy-...... September November 29, 2006 28, 2006 1498–51–7 Phosphorodichloridic acid, ethyl ester ...... September November 29, 2006 28, 2006 1738–25–6 Propanenitrile, 3-(dimethylamino)-...... September November 29, 2006 28, 2006 1912–24–9 1,3,5-Triazine-2,4-diamine, 6-chloro-N-ethyl-N’-(1-methylethyl)-...... September November 29, 2006 28, 2006 2152–64–9 Benzenamine, N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5- September November cyclohexadien-1-ylidene]methyl]-, monohydrochloride. 29, 2006 28, 2006 2210–79–9 Oxirane, [(2-methylphenoxy)methyl]-...... September November 29, 2006 28, 2006 2372–45–4 1-Butanol, sodium salt ...... September November 29, 2006 28, 2006 2409–55–4 Phenol, 2-(1,1-dimethylethyl)-4-methyl-...... September November 29, 2006 28, 2006 2425–54–9 Tetradecane, 1-chloro-...... September November 29, 2006 28, 2006

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Effective Reporting CAS No. Substance date date

Voluntary HPV Challenge Program orphan (unsponsored) chemicals

2494–89–5 Ethanol, 2-[(4-aminophenyl)sulfonyl]-, hydrogen sulfate (ester) ...... September November 29, 2006 28, 2006 2524–03–0 Phosphorochloridothioic acid, O,O-dimethyl ester ...... September November 29, 2006 28, 2006 2691–41–0 1,3,5,7-Tetrazocine, octahydro-1,3,5,7-tetranitro-...... September November 29, 2006 28, 2006 2814–20–2 4(1H)-Pyrimidinone, 6-methyl-2-(1-methylethyl)-...... September November 29, 2006 28, 2006 2905–62–6 Benzoyl chloride, 3,5-dichloro- ...... September November 29, 2006 28, 2006 2915–53–9 2-Butenedioic acid (2Z)-, dioctyl ester ...... September November 29, 2006 28, 2006 3039–83–6 Ethenesulfonic acid, sodium salt ...... September November 29, 2006 28, 2006 3132–99–8 Benzaldehyde, 3-bromo-...... September November 29, 2006 28, 2006 3386–33–2 Octadecane, 1-chloro-...... September November 29, 2006 28, 2006 3779–63–3 1,3,5-Triazine-2,4,6(1H,3H,5H)-trione, 1,3,5-tris(6-isocyanatohexyl)-...... September November 29, 2006 28, 2006 3965–55–7 1,3-Benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt ...... September November 29, 2006 28, 2006 4035–89–6 Imidodicarbonic diamide, N,N’,2-tris(6-isocyanatohexyl)- ...... September November 29, 2006 28, 2006 4170–30–3 2-Butenal ...... September November 29, 2006 28, 2006 4316–73–8 Glycine, N-methyl-, monosodium salt ...... September November 29, 2006 28, 2006 4860–03–1 Hexadecane, 1-chloro-...... September November 29, 2006 28, 2006 5026–74–4 Oxiranemethanamine, N-[4-(oxiranylmethoxy)phenyl]-N-(oxiranylmethyl)-...... September November 29, 2006 28, 2006 5216–25–1 Benzene, 1-chloro-4-(trichloromethyl)-...... September November 29, 2006 28, 2006 5460–09–3 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, monosodium salt ...... September November 29, 2006 28, 2006 5915–41–3 1,3,5-Triazine-2,4-diamine, 6-chloro-N-(1,1-dimethylethyl)-N’-ethyl-...... September November 29, 2006 28, 2006 6473–13–8 2-Naphthalenesulfonic acid, 6-[(2,4-diaminophenyl)azo]-3-[[4-[[4-[[7-[(2,4- September November diaminophenyl)azo]-1-hydroxy-3-sulfo-2-naphthalenyl]azo]phenyl]amino]-3- 29, 2006 28, 2006 sulfophenyl]azo]-4-hydroxy-, trisodium salt. 7795–95–1 1-Octanesulfonyl chloride...... September November 29, 2006 28, 2006 8001–58–9 Creosote ...... September November 29, 2006 28, 2006 10265–69–7 Glycine, N-phenyl-, monosodium salt ...... September November 29, 2006 28, 2006 13749–94–5 Ethanimidothioic acid, N-hydroxy-, methyl ester ...... September November 29, 2006 28, 2006 13826–35–2 Benzenemethanol, 3-phenoxy-...... September November 29, 2006 28, 2006 17103–31–0 Urea, sulfate (2:1) ...... September November 29, 2006 28, 2006 17321–47–0 Phosphoramidothioic acid, O,O-dimethyl ester ...... September November 29, 2006 28, 2006 17976–43–1 2,4,6,8,3,5,7-Benzotetraoxatriplumbacycloundecin-3,5,7-triylidene, 1,9-dihydro-1,9- September November dioxo-. 29, 2006 28, 2006 19438–61–0 1,3-Isobenzofurandione, 5-methyl-...... September November 29, 2006 28, 2006 19525–59–8 Glycine, N-phenyl-, monopotassium salt ...... September November 29, 2006 28, 2006 20068–02–4 2-Butenenitrile, 2-methyl-, (2Z)- ...... September November 29, 2006 28, 2006 20227–53–6 Phosphorous acid, 2-(1,1-dimethylethyl)-4-[1-[3-(1,1-dimethylethyl)-4- September November hydroxyphenyl]-1-methylethyl]phenyl bis(4-nonylphenyl) ester. 29, 2006 28, 2006 21351–39–3 Urea, sulfate (1:1) ...... September November 29, 2006 28, 2006 22527–63–5 Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester ...... September November 29, 2006 28, 2006 24615–84–7 2-Propenoic acid, 2-carboxyethyl ester ...... September November 29, 2006 28, 2006

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Effective Reporting CAS No. Substance date date

Voluntary HPV Challenge Program orphan (unsponsored) chemicals

24794–58–9 Formic acid, compd. with 2,2’,2[ethanol] (1:1) ...... September November 29, 2006 28, 2006 25154–38–5 Piperazineethanol ...... September November 29, 2006 28, 2006 25168–05–2 Benzene, chloromethyl-...... September November 29, 2006 28, 2006 25168–06–3 Phenol, (1-methylethyl)-...... September November 29, 2006 28, 2006 25321–41–9 Benzenesulfonic acid, dimethyl- ...... September November 29, 2006 28, 2006 25383–99–7 Octadecanoic acid, 2-(1-carboxyethoxy)-1-methyl-2-oxoethyl ester, sodium salt ...... September November 29, 2006 28, 2006 25646–71–3 Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate September November (2:3). 29, 2006 28, 2006 26377–29–7 Phosphorodithioic acid, O,O-dimethyl ester, sodium salt ...... September November 29, 2006 28, 2006 26401–27–4 Phosphorous acid, isooctyl diphenyl ester ...... September November 29, 2006 28, 2006 26680–54–6 2,5-Furandione, dihydro-3-(octenyl)-...... September November 29, 2006 28, 2006 27193–28–8 Phenol, (1,1,3,3-tetramethylbutyl)-...... September November 29, 2006 28, 2006 28106–30–1 Benzene, ethenylethyl-...... September November 29, 2006 28, 2006 28188–24–1 Octadecanoic acid, 2-(hydroxymethyl)-2-[[(1-oxooctadecyl)oxy]methyl]-1,3- September November propanediyl ester. 29, 2006 28, 2006 28908–00–1 Benzothiazole, 2-[(chloromethyl)thio]-...... September November 29, 2006 28, 2006 30574–97–1 2-Butenenitrile, 2-methyl-, (2E)- ...... September November 29, 2006 28, 2006 34689–46–8 Phenol, methyl-, sodium salt ...... September November 29, 2006 28, 2006 35203–06–6 Benzenamine, 2-ethyl-6-methyl-N-methylene-...... September November 29, 2006 28, 2006 35203–08–8 Benzenamine, 2,6-diethyl-N-methylene-...... September November 29, 2006 28, 2006 37734–45–5 Carbonochloridothioic acid, S-(phenylmethyl) ester ...... September November 29, 2006 28, 2006 37764–25–3 Acetamide, 2,2-dichloro-N,N-di-2-propenyl-...... September November 29, 2006 28, 2006 38185–06–7 Benzenesulfonic acid, 4-chloro-3,5-dinitro-, potassium salt ...... September November 29, 2006 28, 2006 38321–18–5 Ethanol, 2-(2-butoxyethoxy)-, sodium salt ...... September November 29, 2006 28, 2006 39515–51–0 Benzaldehyde, 3-phenoxy-...... September November 29, 2006 28, 2006 40630–63–5 1-Octanesulfonyl fluoride...... September November 29, 2006 28, 2006 40876–98–0 Butanedioic acid, oxo-, diethyl ester, ion(1-), sodium ...... September November 29, 2006 28, 2006 51632–16–7 Benzene, 1-(bromomethyl)-3-phenoxy-...... September November 29, 2006 28, 2006 52184–19–7 Phenol, 2,4-bis(1,1-dimethylpropyl)-6-[(2-nitrophenyl)azo]-...... September November 29, 2006 28, 2006 52556–42–0 1-Propanesulfonic acid, 2-hydroxy-3-(2-propenyloxy)-, monosodium salt ...... September November 29, 2006 28, 2006 52663–57–7 Ethanol, 2-butoxy-, sodium salt ...... September November 29, 2006 28, 2006 56803–37–3 Phosphoric acid, (1,1-dimethylethyl)phenyl diphenyl ester ...... September November 29, 2006 28, 2006 57693–14–8 Chromate(3-), bis[3-(hydroxy-.kappa.O)-4-[[2-(hydroxy-.kappa.O)-1- September November naphthalenyl]azo-.kappa.N1]-7-nitro-1-naphthalenesulfonato(3-)]-, trisodium. 29, 2006 28, 2006 61788–44–1 Phenol, styrenated...... September November 29, 2006 28, 2006 61788–76–9 Alkanes, chloro...... September November 29, 2006 28, 2006 61789–85–3 Sulfonic acids, petroleum ...... September November 29, 2006 28, 2006 63302–49–8 Phosphorochloridous acid, bis(4-nonylphenyl) ester ...... September November 29, 2006 28, 2006

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Effective Reporting CAS No. Substance date date

Voluntary HPV Challenge Program orphan (unsponsored) chemicals

64743–02–8 Alkenes, C>10 .alpha.- ...... September November 29, 2006 28, 2006 64743–03–9 Phenols (petroleum)...... September November 29, 2006 28, 2006 65996–79–4 Solvent naphtha (coal) ...... September November 29, 2006 28, 2006 65996–82–9 Tar oils, coal ...... September November 29, 2006 28, 2006 65996–83–0 Extracts, coal tar oil alk...... September November 29, 2006 28, 2006 65996–86–3 Extract oils (coal), tar base ...... September November 29, 2006 28, 2006 65996–87–4 Extract residues (coal), tar oil alk...... September November 29, 2006 28, 2006 65996–89–6 Tar, coal, high-temp...... September November 29, 2006 28, 2006 65996–91–0 Distillates (coal tar), upper ...... September November 29, 2006 28, 2006 65996–92–1 Distillates (coal tar) ...... September November 29, 2006 28, 2006 68081–86–7 Phenol, nonyl derivs...... September November 29, 2006 28, 2006 68082–78–0 Lard, oil, Me esters ...... September November 29, 2006 28, 2006 68153–60–6 Fatty acids, tall-oil, reaction products with diethylenetriamine, acetates ...... September November 29, 2006 28, 2006 68187–41–7 Phosphorodithioic acid, O,O-di-C1–14-alkyl esters ...... September November 29, 2006 28, 2006 68187–57–5 Pitch, coal tar-petroleum ...... September November 29, 2006 28, 2006 68187–59–7 Coal, anthracite, calcined ...... September November 29, 2006 28, 2006 68188–18–1 Paraffin oils, chlorosulfonated, saponified ...... September November 29, 2006 28, 2006 68308–74–7 Amides, tall-oil fatty, N,N-di-Me ...... September November 29, 2006 28, 2006 68309–16–0 Fatty acids, tall-oil, 2-(2-hydroxyethoxy)ethyl esters ...... September November 29, 2006 28, 2006 68309–27–3 Fatty acids, tall-oil, sulfonated, sodium salts ...... September November 29, 2006 28, 2006 68334–01–0 Disulfides, alkylaryl dialkyl diaryl, petroleum refinery spent caustic oxidn. products .. September November 29, 2006 28, 2006 68441–66–7 Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid ... September November 29, 2006 28, 2006 68442–60–4 Acetaldehyde, reaction products with formaldehyde, by-products from ...... September November 29, 2006 28, 2006 68442–77–3 2-Butenediamide, (2E)-, N,N’-bis[2-(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1- September November yl)ethyl] derivs.. 29, 2006 28, 2006 68457–74–9 Phenol, isobutylenated methylstyrenated ...... September November 29, 2006 28, 2006 68513–62–2 Disulfides, C5–12-alkyl...... September November 29, 2006 28, 2006 68515–89–9 Barium, carbonate nonylphenol complexes ...... September November 29, 2006 28, 2006 68527–22–0 Naphtha (petroleum), clay-treated light straight-run ...... September November 29, 2006 28, 2006 68584–25–8 Benzenesulfonic acid, C10–16-alkyl derivs., compds. with triethanolamine ...... September November 29, 2006 28, 2006 68602–81–3 Distillates, hydrocarbon resin prodn. higher boiling ...... September November 29, 2006 28, 2006 68608–59–3 Ethane, 1,2-dichloro-, manuf. of, by-products from, distn. lights ...... September November 29, 2006 28, 2006 68609–05–2 Cyclohexane, oxidized, non-acidic by-products, distn. lights ...... September November 29, 2006 28, 2006 68610–90–2 2-Butenedioic acid (2E)-, di-C8–18-alkyl esters ...... September November 29, 2006 28, 2006 68649–42–3 Phosphorodithioic acid, O,O-di-C1–14-alkyl esters, zinc salts ...... September November 29, 2006 28, 2006 68650–36–2 Aromatic hydrocarbons, C8, o-xylene-lean ...... September November 29, 2006 28, 2006

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Effective Reporting CAS No. Substance date date

Voluntary HPV Challenge Program orphan (unsponsored) chemicals

68782–97–8 Distillates (petroleum), hydrofined lubricating-oil ...... September November 29, 2006 28, 2006 68815–50–9 Octadecanoic acid, reaction products with 2-[(2-aminoethyl)amino]ethanol ...... September November 29, 2006 28, 2006 68909–77–3 Ethanol, 2,2’-oxybis-, reaction products with ammonia, morpholine derivs. residues September November 29, 2006 28, 2006 68915–05–9 Fatty acids, tall-oil, low-boiling, reaction products with ammonia-ethanolamine reac- September November tion by-products. 29, 2006 28, 2006 68915–39–9 Cyclohexane, oxidized, aq. ext., sodium salt ...... September November 29, 2006 28, 2006 68918–16–1 Tar, coal, dried and oxidized ...... September November 29, 2006 28, 2006 68919–17–5 Hydrocarbons, C12–20, catalytic alkylation by-products ...... September November 29, 2006 28, 2006 68937–29–1 1,6-Hexanediol, distn. residues ...... September November 29, 2006 28, 2006 68937–70–2 Carboxylic acids, C6–18 and C8–15-di- ...... September November 29, 2006 28, 2006 68937–72–4 Carboxylic acids, di-, C4–11 ...... September November 29, 2006 28, 2006 68953–80–0 Benzene, mixed with toluene, dealkylation product ...... September November 29, 2006 28, 2006 68955–37–3 Acid chlorides, tallow, hydrogenated ...... September November 29, 2006 28, 2006 68955–76–0 Aromatic hydrocarbons, C9–16, biphenyl deriv.-rich ...... September November 29, 2006 28, 2006 68987–41–7 Benzene, ethylenated...... September November 29, 2006 28, 2006 68987–66–6 Ethene, hydrated, by-products from ...... September November 29, 2006 28, 2006 68988–22–7 1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from ...... September November 29, 2006 28, 2006 68990–61–4 Tar, coal, high-temp., high-solids ...... September November 29, 2006 28, 2006 68990–65–8 Fats and Glyceridic oils, vegetable, reclaimed ...... September November 29, 2006 28, 2006 70084–98–9 Terpenes and Terpenoids, C10–30, distn. residues ...... September November 29, 2006 28, 2006 70693–50–4 Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[(2-nitrophenyl)azo]-...... September November 29, 2006 28, 2006 70851–08–0 Amides, coco, N-[3-(dimethylamino)propyl], alkylation products with sodium 3- September November chloro-2-hydroxypropanesulfonate. 29, 2006 28, 2006 71077–05–9 Ethanol, 2,2’-oxybis-, reaction products with ammonia, morpholine product tower September November residues. 29, 2006 28, 2006 72162–15–3 1-Decene, sulfurized...... September November 29, 2006 28, 2006 72854–27–4 Tannins, reaction products with sodium bisulfite, sodium polysulfide and sodium September November sulfite. 29, 2006 28, 2006 73665–18–6 Extract residues (coal), tar oil alk., naphthalene distn. residues ...... September November 29, 2006 28, 2006 83864–02–2 Nickel, bis[(cyano-C)triphenylborato(1-)-N]bis(hexanedinitrile-N,N’)-...... September November 29, 2006 28, 2006 84501–86–0 Hexanedioic acid, esters with high-boiling C6–10-alkene hydroformylation products September November 29, 2006 28, 2006 90640–80–5 Anthracene oil...... September November 29, 2006 28, 2006 90640–86–1 Distillates (coal tar), heavy oils ...... September November 29, 2006 28, 2006 119345–02–7 Benzene, 1,1’-oxybis-, tetrapropylene derivs...... September November 29, 2006 28, 2006 125997–20–8 Phosphoric acid, mixed 3-bromo-2,2-dimethylpropyl and 2-bromoethyl and 2- September November chloroethyl esters. 29, 2006 28, 2006

(Secs 8(a) and 8(d), 90 Stat. 2027, 2029; 15 U.S.C. 2607 (a) and (d)) [47 FR 26998, June 22, 1982]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 712.30, see the List of CFR Sec- tions Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

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EFFECTIVE DATE NOTE: At 59 FR 14115, Mar. 25, 1994, in § 712.30 paragraph (x), the chemical substances under the category ‘‘propylene glycol ethers esters’’ and all related dates were stayed, effective March 25, 1994. At 60 FR 31921, June 19, 1995, § 712.30 was amended in part by redesignating paragraph (x) as paragraph (e).

PART 716—HEALTH AND SAFETY person liable to the United States for a DATA REPORTING civil penalty and possible criminal prosecution. Under section 17, the dis- Subpart A—General Provisions trict courts of the United States have jurisdiction to restrain any violation of Sec. section 15. 716.1 Scope and compliance. 716.3 Definitions. § 716.3 Definitions. 716.5 Persons who must report. 716.10 Studies to be reported. The definitions in section 3 of TSCA 716.20 Studies not subject to the reporting apply to this subpart. In addition, the requirements. following definitions are provided for 716.21 Chemical specific reporting require- the purposes of this subpart: ments. Byproduct means a chemical sub- 716.25 Adequate file search. stance produced without a separate 716.30 Submission of copies of studies. 716.35 Submission of lists of studies. commercial intent during the manufac- 716.40 EPA requests for submission of fur- ture, processing, use, or disposal of an- ther information. other chemical substance(s) or mix- 716.45 How to report on substances and mixture(s). tures. Co-product means a chemical sub- 716.50 Reporting physical and chemical stance produced for a commercial pur- properties. pose during the manufacture, proc- 716.55 Confidentiality claims. essing, use, or disposal of another 716.60 Reporting schedule. 716.65 Reporting period. chemical substance(s) or mixture(s). Copy of study means the written pres- Subpart B—Specific Chemical Listings entation of the purpose and methodology of a study and its results. 716.105 Additions of substances and mix- EPA means the United States Envi- tures to which this subpart applies. 716.120 Substances and listed mixtures to ronmental Protection Agency. which this subpart applies. Health and safety study or study means any study of any effect of a AUTHORITY: 15 U.S.C. 2607(d). chemical substance or mixture on SOURCE: 51 FR 32726, Sept. 15, 1986, unless health or the environment or on both, otherwise noted. including underlying data and epidemiological studies, studies of occupa- Subpart A—General Provisions tional exposure to a chemical substance or mixture, toxicological, clin- § 716.1 Scope and compliance. ical, and ecological or other studies of (a) This subpart sets forth require- a chemical substance or mixture, and ments for the submission of lists and any test performed under TSCA. copies of health and safety studies on (1) It is intended that the term health chemical substances and mixtures se- and safety study be interpreted broadly. lected for priority consideration for Not only is information which arises as testing rules under section 4(a) of the a result of a formal, disciplined study Toxic Substances Control Act (TSCA) included, but other information relat- and on other chemical substances and ing to the effects of a chemical sub- mixtures for which EPA requires stance or mixture on health or the en- health and safety information in ful- vironment is also included. Any data filling the purposes of TSCA. that bear on the effects of a chemical (b) Section 15(3) of TSCA makes it substance on health or the environ- unlawful for any person to fail or ment would be included. Chemical refuse to submit information required identity is part of, or underlying data under this subpart. Section 16 provides to, a health and safety study. that a violation of section 15 renders a (2) Examples are:

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(i) Long- and short-term tests of mu- ment of any duties on the merchandise tagenicity, carcinogenicity, or or an authorized agent acting on his teratogenicity; data on behavioral dis- behalf (as defined in 19 CFR 1.11). Im- orders; dermatoxicity; pharmacological porter also includes, as appropriate: effects; mammalian absorption, dis- (1) The consignee. tribution, metabolism, and excretion; (2) The importer of record. cumulative, additive, and synergistic (3) The actual owner, if an actual effects; and acute, subchronic, and owner’s declaration and superseding chronic effects. bond has been filed in accordance with (ii) Tests for ecological or other envi- 19 CFR 141.20. ronmental effects on invertebrates, (4) The transferee, if the right to fish, or other animals, and plants, in- draw merchandise in a bonded ware- cluding: Acute toxicity tests, chronic house has been transferred in accord- toxicity tests, critical life-stage tests, ance with subpart C of 19 CFR part 144. behavioral tests, algal growth tests, For the purpose of this definition, the seed germination tests, plant growth or customs territory of the United States damage tests, microbial function tests, consists of the 50 States, Puerto Rico, bioconcentration or bioaccumulation and the District of Columbia. tests, and model ecosystem (micro- Impurity means a chemical substance cosm) studies. which is unintentionally present with (iii) Assessments of human and envi- another chemical substance. ronmental exposure, including work- Listed mixture means any mixture place exposure, and impacts of a par- listed in § 716.120. ticular chemical substance or mixture Manufacture means to manufacture on the environment, including surveys, for commercial purposes. tests, and studies of: Biological, photo- Manufacture for commercial purposes chemical, and chemical degradation; means: (1) To produce, with the pur- structure/activity relationships; air, pose of obtaining an immediate or water, and soil transport; bio- eventual commercial advantage for the magnification and bioconcentration; manufacturer, and includes among and chemical and physical properties, other things such ‘‘manufacture’’ of e.g., boiling point, vapor pressure, any amount of a chemical substance or evaporation rates from soil and water, mixture: octanol/water partition coefficient, and (i) For commercial distribution, in- water solubility. cluding for test marketing. (iv) Monitoring data, when they have (ii) For use by the manufacturer, in- been aggregated and analyzed to meas- cluding use for product research and ure the exposure of humans or the en- development, or as an intermediate. vironment to a chemical substance or (2) Manufacture for commercial pur- mixture. poses also applies to substances that Import means to import for commer- are produced coincidentally during the cial purposes. manufacture, processing, use, or dis- Import for commercial purposes means posal of another substance or mixture, to import with the purpose of obtain- including byproducts and impurities. ing an immediate or eventual commer- Such byproducts and impurities may, cial advantage for the importer, and in- or may not, in themselves have com- cludes the importation of any amount mercial value. They are nonetheless of a chemical substance or mixture. If produced for the purpose of obtaining a a chemical substance or mixture con- commercial advantage since they are taining impurities is imported for compart of the manufacture of a chemical mercial purposes, then those impuri- product for a commercial purpose. ties are also imported for commercial Manufacturer means a person who purposes. produces or manufactures a chemical Importer means any person who im- substance. A person who extracts a ports a chemical substance, including a component chemical substance from a chemical substance as a part of a mix- previously existing chemical substance ture or article, into the customs terri- or a complex combination of sub- tory of the United States and includes stances is a manufacturer of that com- the person primarily liable for the pay- ponent chemical substance.

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Person includes any individual, firm, (2) As of the effective date on which company, corporation, joint-venture, a substance or mixture is added to partnership, sole proprietorship, asso- § 716.120, and who propose to manufac- ciation, or any other business entity, ture (including import), or who are any State or political subdivision manufacturing (including importing) thereof, any municipality, any inter- the listed substance or listed mixture state body, and any department, agen- (including as a known byproduct), are cy, or instrumentality of the Federal required to report during the reporting government. period specified in § 716.65. Process means to process for commer- (3) After the effective date on which cial purposes. a substance or mixture is added to Process for commercial purposes means § 716.120, and who propose to manufac- the preparation of a chemical sub- ture (including import) the listed substance or mixture, after its manufac- stance or listed mixture (including as a ture, for distribution in commerce with known byproduct), are required to re- the purpose of obtaining an immediate port during the reporting period speci- or eventual commercial advantage for fied in § 716.65. the processor. Processing of any (b) A rule promulgated under the au- amount of a chemical substance or thority of 15 U.S.C. 2607(d) may require mixture is included. If a chemical sub- that any person who does not fall with- stance or mixture containing impuri- in NAICS (in effect as of January 1, ties is processed for commercial pur- 1997) Subsector 325 or Industry Group poses, then those impurities are also 32411, and who had proposed to manu- processed for commercial purposes. facture (including import) or process, Propose to manufacture, import, or had manufactured (including imported) process means that a person has made a or processed, proposes to manufacture management decision to commit finan- (including import) or process, or is cial resources toward the manufacture, manufacturing (including importing) importation, or processing of a sub- or processing a substance or mixture stance or mixture. listed in § 716.120 must report under this Substance means chemical substance as part. defined at section 3(2)(A) of TSCA, 15 (c) Processors and persons who pro- U.S.C. 2602(2)(A). pose to process a substance or mixture TSCA means the Toxic Substances otherwise subject to the reporting re- Control Act (15 U.S.C. 2601 et seq.). quirements imposed by this part are not subject to this part unless EPA § 716.5 Persons who must report. specifically states otherwise in a par- (a) Except as provided in paragraphs ticular notice or rule promulgated (b) and (c) of this section, only those under the authority of 15 U.S.C. 2607(d). persons described in this section are required to report under this part. Per- [63 FR 15773, Apr. 1, 1998] sons who must report include manufac- § 716.10 Studies to be reported. turers (including importers) who fall within the North American Industry (a) In general, health and safety stud- Classification System (NAICS) (in ef- ies, as defined in § 716.3, on any sub- fect as of January 1, 1997) Subsector 325 stance or listed mixture listed in (chemical manufacturing and allied § 716.120, that are unpublished are re- products) or Industry Group 32411 (pe- portable, i.e., must be submitted or troleum refineries), who: listed. However, this requirement has (1) In the 10 years preceding the effec- limitations according to the nature of tive date on which a substance or mix- the material studied, so that: ture is added to § 716.120, either had (1) All studies of substances and list- proposed to manufacture (including ed mixtures are reportable. However, in import), or had manufactured (includ- the case of physical and chemical prop- ing imported) the listed substance or erties, only those studies listed in listed mixture (including as a known § 716.50 must be submitted. byproduct), are required to report dur- (2) Studies of mixtures known to con- ing the reporting period specified in tain substances or listed mixtures list- § 716.65. ed in § 716.120 are reportable except for

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studies of physical and chemical prop- (5) Studies of chemical substances erties and the studies exempted at which are not on the TSCA Chemical § 716.20(a)(6) (i) through (vi). Substances Inventory. This exemption (3) Studies of substances or listed applies only to those substances within mixtures that a person who is report- categories listed under § 716.120(c). ing has manufactured, imported, or (6) The following types of studies processed or proposed to manufacture, when the subject of the study is a mix- import, or process only as impurities ture known to contain a substance or are not generally reportable under listed mixture listed under § 716.120. § 716.20(a)(9). (i) Acute oral toxicity studies. (4) Underlying data, such as medical (ii) Acute dermal toxicity studies. or health records, individual files, lab (iii) Acute inhalation toxicity stud- notebooks, and daily monitoring ies. records supporting studies do not have (iv) Primary eye irritation studies. to be submitted initially. EPA may re- (v) Primary dermal irritation stud- quest underlying data later under ies. (vi) Dermal sensitization studies. § 716.40. (vii) Physical and chemical prop- (b) [Reserved] erties. § 716.20 Studies not subject to the re- If the substance or listed mixture is an porting requirements. impurity, no reporting is required (see paragraph (a)(9) of this section). (a) Excluding paragraph (a)(3) of this (7) Analyzed aggregations of moni- section, the following types of studies toring data based on monitoring data are exempt from the copy and list sub- acquired more than 5 years preceding mission requirements of §§ 716.30 and the date the substance or listed mix- 716.35. ture was added to the list under (1) Studies which have been published § 716.120. in the scientific literature. (8) Analyzed aggregations of moni- (2) Studies previously submitted to toring data on mixtures known to con- the EPA Office of Pollution Prevention tain one or more substances or listed and Toxics. These studies are limited mixtures listed in § 716.120, when the to section 8(e) submissions, studies monitoring data are not analyzed to submitted during section 4 proceedings, determine the exposure or concentra- studies submitted with premanufacture tion levels of the substances or listed notices or significant new use notices, mixture listed under § 716.120. and studies submitted ‘‘for your infor- (9) Studies on a substance or listed mation’’ (FYI submissions) in support mixture listed under § 716.120 that the of EPA’s TSCA Existing Chemicals person who is reporting has manufac- Program. Studies which have been ini- tured, imported, or processed or pro- tiated pursuant to a TSCA section 4(a) posed to manufacture, import, or proc- test rule, for which the person has sub- ess only as an impurity. When report- mitted a letter of intent to conduct ing of such studies is to be required, testing in accordance with the provi- that reporting will be separately pro- sions of § 790.25 of part 790 of this chap- posed in the FEDERAL REGISTER. ter, are exempt from the list submis- (10) Studies of chemical substances or sion requirements of § 716.35. listed mixtures previously submitted (3) Except for those studies described by trade associations in accordance in paragraph (a)(2) of this section, stud- with the provisions of § 716.30. ies previously submitted to any Fed- (b) The following types of studies on eral agency with no claims of confiden- substances or listed mixtures listed tiality are exempt only from the copy under § 716.120 are exempt from the submission requirements of § 716.30, and copy and list submission requirements must be listed in accordance with the of §§ 716.30 and 716.35. provisions of § 716.35. (1) For the listed ureaformaldehyde (4) Studies conducted or initiated by resins (CAS Nos. 9011–05–6 and 68611–64– or for another person who is subject to, 3), studies on agronomic plant growth and who will report the studies under or damage which demonstrate only §§ 716.30 and 716.35. that the resins stimulate plant growth

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or cause plant damage when applied as equal to 90% of the test substance by a fertilizer. weight must be submitted. (2) For the specified chemicals in (2) For benzenamine, 3-chloro-2,6- § 716.120(d) under the category dinitro-N,N-dipropyl-4- ‘‘Siloxanes,’’ acute oral, dermal, and (trifluoromethyl)-, all unpublished en- inhalation toxicity studies and pri- vironmental effects studies including mary eye and dermal irritation studies. bioconcentration, environmental fate (3) For the listed chemicals under studies on biodegradation, and health § 716.120(d) in the category ‘‘OSHA effects studies on pharmacokinetics, Chemicals in Need of Dermal Absorp- subchronic toxicity, mutagenicity, re- tion Testing,’’ studies on ecological ef- productive effects, and developmental fects. toxicity, and carcinogenicity where the (4) For the chemicals listed at purity of benzenamine, 3-chloro-2,6- § 716.120 with a special exemption ref- dinitro-N,N-dipropyl-4- erencing this paragraph, studies on (trifluoromethyl)- is greater than or mixtures containing the listed sub- equal to 90% of the test substance by stance at levels below 1 percent of the weight must be submitted. mixture, except when a purpose of the (3) For stannane, dimethylbis[(1- study includes the investigation of the oxoneodecyl)oxy]-, all unpublished en- effects of the listed substance at levels vironmental effects studies including below 1 percent. bioconcentration, environmental fate (5) Rulemaking proceedings that add studies on hydrolysis and biodegrada- substances and mixtures to § 716.120 tion and health effects studies on phar- will specify the types of health and/or macokinetics, subchronic toxicity, mu- environmental effects studies that tagenicity, neurotoxicity, reproductive must be reported and will specify the effects, and developmental toxicity, chemical grade/purity requirements and carcinogenicity where the purity that must be met or exceeded in indi- of stannane, dimethylbis[(1- vidual studies. Chemical grade/purity oxoneodecyl)oxy]- is greater than or requirements will be specified on a per equal to 90% of the test substance by chemical basis or for a category of weight must be submitted. chemicals for which reporting is re- (4) For benzene, 1,3,5-tribromo-2-(2- quired. propenyloxy)-, all unpublished environ- [51 FR 32726, Sept. 15, 1986, as amended at 58 mental effects studies including bio- FR 47649, Sept. 10, 1993; 58 FR 68315, Dec. 27, concentration, environmental fate 1993; 60 FR 34884, July 5, 1995; 63 FR 15773, studies on biodegradation and health Apr. 1, 1998] effects studies on pharmacokinetics, subchronic toxicity, neurotoxicity, re- § 716.21 Chemical specific reporting productive effects, and developmental requirements. toxicity, and carcinogenicity where the (a) Health and safety studies report- purity of benzene, 1,3,5-tribromo-2-(2- able under part 716 for the following propenyloxy)- is greater than or equal chemical substances, mixtures, or cat- to 90% of the test substance by weight egories of chemical substances, as list- must be submitted. ed in § 716.120, must be submitted or (5) For 1-triazene, 1,3-diphenyl-, all listed only as specified in this section: unpublished health effects studies on (1) For 3H-1,2,4-triazole-3-thione, 5- pharmacokinetics, genotoxicity, sub- amino-1,2-dihydro- and imidazo[4,5- chronic and chronic toxicity, reproduc- d]imidazole-2,5-(1H,3H)-dione, tive effects, and developmental tox- tetrahydro-, all unpublished environ- icity where the purity of 1-triazene, 1,3- mental effects studies and health ef- diphenyl- is greater than or equal to fects studies on pharmacokinetics, 90% of the test substance by weight genotoxicity, subchronic toxicity, must be submitted. immunotoxicity, carcinogenicity, re- (6) For the 9 chemicals in the indium productive effects, and developmental compound category, all unpublished toxicity where the purity of 3H-1,2,4- health effects studies on pharmaco- triazole-3-thione, 5-amino-1,2-dihydro- kinetics, genotoxicity, subchronic and or imidazo[4,5-d]imidazole-2,5-(1H,3H)- chronic toxicity, reproductive effects, dione, tetrahydro- is greater than or and developmental toxicity where the

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purity of the indium compound is Act (FIFRA), Organization for Eco- greater than or equal to 90% of the test nomic Cooperation and Development substance by weight must be sub- (OECD) or other internationally ac- mitted. cepted test guidelines or voluntary (7) For all voluntary HPV Challenge consensus standards should be sub- Program orphan (unsponsored) chemi- mitted. Studies performed where the cals: voluntary HPV Challenge Program or- (i) All unpublished environmental phan (unsponsored) chemical is < 90% fate studies, meeting the criteria set of the test substance by weight are not forth in paragraph (a)(7)(iv) of this sec- requested at this time. tion, on water solubility; adsorption/ (8)(i) Reporting requirements apply desorption on particulate surfaces, e.g., only to manufacturers (including im- soil; vapor pressure; octanol/water par- porters) of consumer products intended tition coefficient; density/relative den- for use by children who also manufac- sity (specific gravity); particle size dis- ture (including import) lead or lead tribution for insoluble solids; dissocia- compounds. For the category ‘‘lead and tion constant; degradation by photo- lead compounds,’’ all unpublished chemical mechanisms—aquatic and at- health and safety studies that: mospheric; degradation by chemical (A) Relate to the lead content of con- mechanisms—hydrolytic, reductive, sumer products that are ‘‘intended for and oxidative; degradation by biologi- use by children’’ as that term is de- cal mechanisms—aerobic and anaer- fined at 40 CFR 710.43 (excluding chil- obic. Studies of physical and chemical dren’s metal jewelry), or properties meeting the criteria set (B) Assess children’s exposure to lead forth in paragraph (a)(7)(iv) of this sec- from such products (including studies tion must be reported if performed for of bioavailability). the purpose of determining the envi- (ii) With regard to purity, studies ronmental or biological fate of a sub- showing any measurable lead content stance, and only if they investigated in such products must be submitted. one or more of the properties listed in (b) [Reserved] this paragraph. In addition, all unpublished studies meeting the criteria set [69 FR 24522, May 4, 2004, as amended at 71 FR 47135, Aug. 16, 2006; 73 FR 5115, Jan. 29, forth in paragraph (a)(7)(iv) of this sec- 2008] tion on melting point and boiling point must be submitted. § 716.25 Adequate file search. (ii) All unpublished health effects The scope of a person’s responsibility studies meeting the criteria set forth to search records is limited to records in paragraph (a)(7)(iv) of this section in the location(s) where the required including pharmacokinetics, information is typically kept, and to genotoxicity, acute toxicity, subacute records kept by the person or the per- toxicity, subchronic toxicity, chronic son’s individual employee(s) who is/are toxicity, reproductive toxicity, devel- responsible for keeping such records or opmental toxicity, immunotoxicity, advising the person on the health and neurotoxicity, and oncogenicity/car- environmental effects of chemicals. cinogenicity. Persons are not required to search for (iii) All unpublished environmental reportable information dated before effects studies meeting the criteria set January 1, 1977, to comply with this forth in paragraph (a)(7)(iv) of this sec- subpart unless specifically required to tion including acute and chronic tox- do so in a rule. icity studies of aquatic and terrestrial vertebrates and invertebrates and [63 FR 15773, Apr. 1, 1998] aquatic plants. (iv) Only studies where the voluntary § 716.30 Submission of copies of stud- HPV Challenge Program orphan ies. (unsponsored) chemical is ≥ 90% of the (a)(1) Except as provided in §§ 716.5, test substance by weight should be sub- 716.20, and 716.50, persons must send to mitted. In addition, only studies that EPA copies of any health and safety were conducted using TSCA, Federal studies in their possession for the sub- Insecticide, Fungicide, and Rodenticide stances or mixtures listed in § 716.120.

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Persons are responsible for submitting tion/Reporting). The DCO is open from copies on only the substances or listed 8 a.m. to 4 p.m., Monday through Fri- mixtures which they: Have manufac- day, excluding legal holidays. The tele- tured, imported, or processed or pro- phone number for the DCO is (202) 564– posed to manufacture, import, or proc- 8930. Such deliveries are only accepted ess (including as known byproducts) during the DCO’s normal hours of oper- within the 10 years preceding the effec- ation. tive date for reporting on the sub- [51 FR 32726, Sept. 15, 1986, as amended at 52 stances or listed mixtures; manufac- FR 20084, May 29, 1987; 52 FR 44828, Nov. 20, ture, import, or process on the effec- 1987; 53 FR 12523, Apr. 15, 1988; 60 FR 34463, tive date for reporting on the sub- July 3, 1995; 63 FR 15773, Apr. 1, 1998; 71 FR stances or listed mixtures; and propose 47135, Aug. 16, 2006] to manufacture, import, or process following the effective date for reporting § 716.35 Submission of lists of studies. on the substances or listed mixtures. (a) Except as provided in §§ 716.5, Persons who list studies as ongoing or 716.20, and 716.50, persons subject to initiated under § 716.35(a) (1) and (2) this rule must send lists of studies to must submit them when they are com- EPA for each of the listed substances pleted. or listed mixtures (including as a (2) [Reserved] known byproduct) in § 716.120 which (b) Submissions under paragraph (a) they are manufacturing, importing, or of this section must be identified either processing, or which they propose to on the face of the study or otherwise manufacture (including import) or by the applicable chemical name and process. CAS number (if any) listed in (1) Ongoing studies. As of the date a § 716.120(a) (1) and (2), and must be ac- person becomes subject to this part, a companied by a cover letter containing list of ongoing health and safety stud- the name, job title, address and tele- ies being conducted by or initiated for phone number of the submitting offi- them, noting for each entry: The begin- cial, and the name and address of the ning date of the study, the purpose of manufacturing or processing establish- the study, the types of data to be col- ment on whose behalf the submission is lected, the anticipated date of comple- made. In the cover letter, submitters tion, and the name and address of the must identify any impurity or additive laboratory conducting the study. known to have been present in the sub- (2) Initiated studies. After the date a stance or listed mixtures as studied un- person becomes subject to this part, a less its presence is specifically noted in list of studies initiated by or for them, the study itself. The cover letter ac- noting for each entry: The beginning companying a study submitted by a date of the study, the purpose of the trade association must also state that study, the types of data to be collected, the submission is to satisfy reporting the anticipated date of completion, and requirements under this part. the name and address of the laboratory (c) You must submit copies of health conducting the study. and safety studies and the accom- (3) Studies which are known but with- panying cover letters by one of the fol- out possession of copies. As of the date a lowing methods: person becomes subject to this part, a (1) Mail, preferably certified, to the list of unpublished health and safety Document Control Office (DCO) studies known to them of which they (7407M), Office of Pollution Prevention do not have copies. The name and ad- and Toxics (OPPT), Environmental dress of any person known to them to Protection Agency, 1200 Pennsylvania possess a copy of the unpublished study Ave., NW., Washington, DC 20460–0001, must accompany each entry on the ATTN: 8(d) Health and Safety Report- list. For purposes of this section only, ing Rule (Notification/Reporting). an unpublished study will be consid- (2) Hand delivery to OPPT Document ered to be ‘‘known to’’ a person, if the Control Office (DCO), EPA East, Rm. study can be discovered by a file search 6428, 1201 Constitution Ave., NW., in accordance with § 716.25. Washington, DC, ATTN: 8(d) Health (4) Studies previously sent to Federal and Safety Reporting Rule (Notifica- agencies without confidentiality claims. A

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list of unpublished studies which have during the DCO’s normal hours of oper- been sent to a Federal Agency with no ation. claims of confidentiality. The submis- [51 FR 32726, Sept. 15, 1986, as amended at 52 sion must for each study: Identify the FR 20084, May 29, 1987; 52 FR 44828, Nov. 20, study by title, state the name and ad- 1987; 53 FR 12523, Apr. 15, 1988; 53 FR 46746, dress to whom the study was sent, and Nov. 18, 1988; 60 FR 34463, July 3, 1995; 63 FR the month and year in which the study 15774, Apr. 1, 1998; 71 FR 47135, Aug. 16, 2006] was submitted. Any study identified will be treated as if it were submitted § 716.40 EPA requests for submission under section 8(d) and will be available of further information. for public disclosure under section 14(b) EPA may, by letter, request a person of TSCA. Persons subject to this re- to submit or make available for review quirement may submit either a list of the following information after the ini- unpublished health and safety studies tial reporting under §§ 716.30 and 716.35. previously submitted to any Federal If the requested submissions are not agency without claims of confiden- made, EPA may subpoena them under tiality in accordance with § 716.35(a)(4), section 11 of TSCA, 15 U.S.C. 2610. or copies of each such study in accord- (a) Submission of underlying data of ance with § 716.30. the kind described in § 716.10(a)(4) by (b) Submission under paragraph (a) of persons who submit copies of studies this section must be identified either under § 716.30 or list studies under on the face of the study or otherwise § 716.35(a)(1) or § 716.35(a)(2). by the applicable chemical name and (b) Submission of preliminary reports CAS number (if any) listed in of ongoing studies by persons who list § 716.120(a) (1) and (2), and must be ac- the studies under § 716.35(a)(1) or companied by a cover letter containing § 716.35(a)(2). the name, job title, address and tele- (c) Submission of copies of studies by phone numbers of the submitting offi- persons listed under § 716.35(a)(3) as pos- cial, and the name and address of the sessing them. manufacturing or processing establish- § 716.45 How to report on substances ment on whose behalf the submission is and mixtures. made. (c) You must submit lists of health Section 716.120 lists substances and and safety studies by one of the fol- mixtures, in order by Chemical Ab- lowing methods: stract Service Registry Number and by (1) Mail, preferably certified, to the alphabetical order. Studies of listed Document Control Office (DCO) substances and listed mixtures shall be reported as follows: (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental (a) When a substance is individually Protection Agency, 1200 Pennsylvania listed under § 716.120(a), studies of the substance and studies of mixtures Ave., NW., Washington, DC 20460–0001, known to contain the substance must ATTN: 8(d) Health and Safety Report- be reported as studies of that sub- ing Rule (Notification/Reporting). stance. (2) Hand delivery to OPPT Document (b) When two or more substances are Control Office (DCO), EPA East, Rm. listed as a mixture under § 716.120(b), 6428, 1201 Constitution Ave., NW., studies of the listed mixture and stud- Washington, DC, ATTN: 8(d) Health ies of any mixture known to contain and Safety Reporting Rule (Notifica- the listed mixture must be reported as tion/Reporting). The DCO is open from studies of the listed mixture. 8 a.m. to 4 p.m., Monday through Fri- (c) Studies of the following prepara- day, excluding legal holidays. The tele- tions of a substance must be reported phone number for the DCO is (202) 564– as studies of the substance itself, not 8930. Such deliveries are only accepted as studies of mixtures known to contain the substance. (1) The substance in aqueous solution.

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(2) The substance containing a small (ii) The portion of a mixture com- amount of an additive, such as a sta- prised by any of the substances in the bilizer, emulsifier, or other chemical mixture. added for purposes of maintaining the (2) Any respondent who wishes to as- integrity or physical form of the sub- sert a claim that part of a study should stance. be withheld from disclosure because (3) The substance of the grade/purity disclosure would reveal a confidential specified in each rule promulgated process or quantitative mixture com- under 15 U.S.C. 2607(d). position should briefly state the basis [51 FR 32726, Sept. 15, 1986, as amended at 63 of the claim, e.g., by saying ‘‘reveals FR 15774, Apr. 1, 1998] confidential mixture proportion data,’’ and clearly identify the material sub- § 716.50 Reporting physical and chem- ject to the claim. ical properties. (3) Any respondent may assert a con- Studies of physical and chemical fidentiality claim for company name or properties must be reported under this address, financial statistics, and prod- subpart if performed for the purpose of uct codes used by a company. This in- determining the environmental or bio- formation will not be subject to the logical fate of a substance, and only if disclosure requirements of section 14(b) they investigated one or more of the of TSCA. following properties: (4) Information other than company (a) Water solubility. name or address, financial statistics, (b) Adsorption/desorption on particu- and product codes used by a company, late surfaces, e.g., soil. which is contained in a study, the dis- (c) Vapor pressure. closure of which would clearly be an (d) Octanol/water partition coeffi- unwarranted invasion of personal pri- cient. vacy (such as individual medical (e) Density/relative density (specific records), will be considered confiden- gravity). tial by EPA as provided in Title 5, (f) Particle size distribution for insol- United States Code, section 552(b)(6). uble solids. (b) To assert a claim of confiden- (g) Dissociation constant. tiality for data contained in a sub- (h) Degradation by photochemical mitted document, the respondent must mechanisms—aquatic and atmospheric. submit two copies of the document: (i) Degradation by chemical mecha- (1) One copy must be complete. In nisms—hydrolytic, reductive, and that copy, the respondent must indi- oxidative. cate what data, if any, are claimed as (j) Degradation by biological mecha- confidential by bracketing or under- nisms—aerobic and anaerobic. lining the specific information. Each page containing data claimed as con- § 716.55 Confidentiality claims. fidential must also contain a brief (a)(1) Section 14(b) of TSCA provides statement for the basis of the claim as that EPA may not withhold from dis- well as a label such as ‘‘confidential,’’ closure, on the grounds that they are ‘‘proprietary,’’ or ‘‘trade secret.’’ confidential business information, (2) The second copy must be com- health and safety studies of any sub- plete, except that all information stance or mixture that has been offered claimed as confidential in the first for commercial distribution (including copy must be deleted. The second copy for test marketing purposes and for use will be immediately subject to public in research and development), any sub- disclosure. stance or mixture for which testing is (3) Failure to furnish a second copy required under TSCA section 4, or any when information is claimed as con- substance for which notice is required fidential in the first copy will be con- under TSCA section 5, except to the ex- sidered a presumptive waiver of the tent that disclosure of data from such claim of confidentiality. EPA will no- studies would reveal— tify the respondent by certified mail (i) Processes used in the manufac- that a finding of a presumptive waiver turing, importing, or processing of the of the claim of confidentiality has been substance or mixture, or made. The respondent will be given 30

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days from the date of his or her receipt (2) Hand delivery to OPPT Document of this notification to submit the re- Control Office (DCO), EPA East, Rm. quired second copy. If the respondent 6428, 1201 Constitution Ave., NW., fails to submit the second copy within Washington, DC, ATTN: Section 8(d) the 30 days, EPA will place the first Extension. The DCO is open from 8 a.m. copy in the public file. to 4 p.m., Monday through Friday, ex- (c) If no claim of confidentiality ac- cluding legal holidays. The telephone companies a document at the time it is number for the DCO is (202) 564–8930. submitted to EPA, the document will Such deliveries are only accepted dur- be placed in an open file available to ing the DCO’s normal hours of oper- the public without further notice to ation. the respondent. [51 FR 32726, Sept. 15, 1986, as amended at 60 § 716.60 Reporting schedule. FR 34464, July 3, 1995; 63 FR 15774, Apr. 1, (a) General requirements. Except as 1998; 71 FR 47135, Aug. 16, 2006] provided in § 716.5 and paragraphs (b) and (c) of this section, submissions § 716.65 Reporting period. under §§ 716.30 and 716.35 must be post- Unless otherwise required in a rule marked on or before 60 days after the promulgated under 15 U.S.C. 2607(d) re- effective date of the listing of a sub- lating to a listed chemical substance or stance or mixture in § 716.120 or within listed mixture [hereinafter ‘‘rule’’], the 60 days of proposing to manufacture reporting period for a listed chemical (including import) or process a listed substance or listed mixture will termi- substance or listed mixture (including nate 60 days after the effective date on as a known byproduct) if first done which the listed chemical substance or after the effective date of the sub- listed mixture is added to 40 CFR stance or mixture being listed in 716.120. EPA may require reporting for § 716.120. a listed chemical substance or listed (b)(1) Submission of lists of initiated mixture beyond the 60 day period in a studies. Persons subject to the listing rule promulgated under 15 U.S.C. requirements of § 716.35(a)(2) must in- 2607(d), however EPA will not extend form EPA of the initiated study within any reporting period later than 2 years 30 days of its initiation. after the effective date on which a list- (2) Submission of copies of completed ed chemical substance or listed mix- studies. Persons must submit copies of ture is added to 40 CFR 716.120. After studies listed as ongoing or initiated under § 716.35(a) (1) and (2) within 30 the applicable reporting period termi- days of completing the study. nates, any person subject to the rule (c) Requests for extensions of time. Re- under 40 CFR 716.5 (a)(2) or (a)(3) and spondents who cannot meet a deadline who has submitted to EPA lists of on- under this section may apply for a rea- going or initiated studies under 40 CFR sonable extension of time. Extension 716.35 (a)(1) or (a)(2) must submit a requests must be postmarked on or be- copy of any such study within 30 days fore 40 days after the effective date of after its completion, regardless of the the listing of a substance or mixture in study’s completion date. § 716.120. The Director of EPA’s Office [63 FR 15774, Apr. 1, 1998] of Pollution Prevention and Toxics will grant or deny extension requests. (d) Submission methods. You must sub- Subpart B—Specific Chemical mit a request for an extension of time Listings in writing by one of the following methods: § 716.105 Additions of substances and (1) Mail, preferably certified, to the mixtures to which this subpart applies. Director, Office of Pollution Preven- tion and Toxics (OPPT) (7401M), Envi- The requirements of this subpart will ronmental Protection Agency, 1200 be extended periodically to cover addi- Pennsylvania Ave., NW., Washington, tional substances and mixtures. Two DC 20460–0001, ATTN: Section 8(d) Ex- procedures will be used to add sub- tension. stances and mixtures.

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(a) Except as provided in paragraph (d) Persons who wish to submit infor- (b) of this section, substances and mix- mation that shows why a chemical tures will be added to § 716.120 after should be withdrawn must submit their publication in the FEDERAL REGISTER comments in writing by one of the fol- of a notice of proposed amendment to lowing methods: this subpart. There will be at least a (1) Mail, preferably certified, to the 30-day public comment period on the Document Control Office (DCO) notice. After consideration of the com- (7407M), Office of Pollution Prevention ments, EPA will amend § 716.120 by and Toxics (OPPT), Environmental final rule to add the substances and Protection Agency, 1200 Pennsylvania listed mixtures. Ave., NW., Washington, DC 20460–0001, (b) Except as provided in paragraph ATTN: 8(d) Auto-ITC. (c) of this section, chemical sub- (2) Hand delivery to OPPT Document stances, mixtures, and categories of Control Office (DCO), EPA East, Rm. chemical substances that have been 6428, 1201 Constitution Ave., NW., added to the TSCA section 4(e) Priority Washington, DC, ATTN: 8(d) Auto-ITC. List by the Interagency Testing Com- The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding mittee, established under section 4 of legal holidays. The telephone number TSCA, will be added to § 716.120 but for the DCO is (202) 564–8930. Such de- only to the extent that the total num- liveries are only accepted during the ber of designated and recommended DCO’s normal hours of operation. substances, mixtures and categories of chemical substances has not exceeded [51 FR 32726, Sept. 15, 1986, as amended at 60 50 in any 1 year. The addition of such FR 34464, July 3, 1995; 71 FR 47135, Aug. 16, chemical substances, mixtures, and 2006] categories of chemical substances to § 716.120 Substances and listed mix- § 716.120 will be effective 30 days after tures to which this subpart applies. publication of a notice to that effect in Substances listed in this section ap- the FEDERAL REGISTER. pear in order by Chemical Abstract (c) Prior to the effective date of an Service Registry Number. Chemical amendment under paragraph (b) of this mixtures and categories are listed sep- section, the Assistant Administrator arately and by alphabetical order. for Prevention, Pesticides and Toxic Chemical substances listed within a Substances may for good cause with- category are provided only as examples draw a chemical substance, mixture, or of the category, and are not included category of chemical substances from on the list of substances. When a chem- § 716.120. Any information submitted ical substance in the substance or cat- showing why a chemical substance, egory list had been listed previously by mixture, or category of chemical sub- a trivial (or common) name, it appears stances should be withdrawn from the first, followed by the Chemical Ab- amendment must be received by EPA stract Service (CAS) name appearing in within 14 days after the date of publi- the TSCA Chemical Substance Inven- cation of the notice under paragraph tory. (b) of this section. If a chemical sub- (a) List of substances. The following stance, mixture, or category of chem- chemical substances are subject to all ical substances is withdrawn, a FED- the provisions of part 716. Manufactur- ERAL REGISTER notice announcing this ers, importers, and processors of a list- decision will be published no later than ed substance are subject to the report- the effective date of the amendment ing requirements of subpart A for that under paragraph (b) of this section. substance.

Effective CAS No. Substance Special exemptions date Sunset date

62–74–8 Acetic acid, fluoro-, sodium salt ...... 03/07/86 03/07/96 67–63–0 2-Propanol ...... 12/15/86 12/15/96 67–66–3 Methane, trichloro-...... 06/01/87 06/01/97 67–72–1 Ethane, hexachloro-...... 04/29/83 01/13/86 68–12–2 Dimethyl formamide-Formamide, N,N-dimethyl- ...... 4/13/89 12/19/95 71–55–6 1,1,1-Trichloroethane—Ethane, 1,1,1-trichloro-...... 10/04/82 10/04/92

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Effective CAS No. Substance Special exemptions date Sunset date

74–83–9 Methane, bromo-...... 06/01/87 06/01/97 74–87–3 Chloromethane—Methane, chloro-...... 10/04/82 10/04/92 74–95–3 Methane, dibromo-...... 6/1/87 12/19/95 74–97–5 Methane, bromochloro-...... 6/1/87 12/19/95 75–00–3 Ethane, chloro-...... 06/01/87 06/01/97 75–02–5 Vinyl fluoride—Ethene, fluoro- ...... 10/04/82 10/04/92 75–04–7 Ethanamine ...... 6/1/87 12/19/95 75–05–8 Acetonitrile ...... 10/04/82 10/04/92 75–09–2 Methylene chloride—Methane, dichloro- ...... 10/04/82 10/04/92 75–12–7 Formamide ...... 04/29/83 04/29/93 75–21–8 Oxirane ...... 10/04/82 10/04/92 75–25–2 Methane, tribromo-...... 06/01/87 06/01/97 75–27–4 Methane, bromodichloro-...... 6/1/87 12/19/95 75–29–6 Propane, 2-chloro-...... 6/1/87 12/19/95 75–34–3 Ethane, 1,1-dichloro-...... 06/01/87 06/01/97 75–37–6 1,1-Difluoroethane-Ethane, 1,1-difluoro-...... 4/13/89 12/19/95 75–38–7 Vinylidene fluoride—Ethene, 1,1-difluoro- ...... 10/04/82 10/04/92 75–43–4 Dichloromonofluoromethane-Methane, dichlorofluoro- ...... 4/13/89 12/19/95 75–45–6 Chlorodifluoromethane—Methane, chlorodifluoro-...... 4/13/89 6/30/98 75–52–5 Nitromethane-Methane, nitro-...... 4/13/89 12/19/95 75–56–9 Oxirane, methyl-...... 10/04/82 10/04/92 75–68–3 1-Chloro-1,1-difluoroethane-Ethane, 1-chloro-1,1- ...... 4/13/89 12/19/95 difluoro. 75–86–5 Propanenitrile, 2-hydroxy-2-methyl-...... 3/7/86 12/19/95 75–88–7 Ethane, 2-chloro- 1,1,1-trifluoro ...... 10/15/90 11/09/93 76–13–1 1,1,2-Trichloro-1,2,2-trifluoroethane-Ethane, 1,1,2- ...... 4/13/89 12/19/95 trichloro-1,2,2-trifluoro-1. 77–47–4 Hexachlorocyclopentadiene—1,3-Cyclopentadiene, ...... 10/04/82 10/04/92 1,2,3,4,5,5-hexachloro-. 77–58–7 Dibutyltin dilaurate—Stannane, dibutylbis[(1- ...... 01/03/83 01/03/93 oxododecyl)oxy]-. 78–59–1 Isophorone—2-Cyclohexen-1-one, 3,5,5-trimethyl-...... 10/04/82 10/04/92 78–83–1 1-Propanol, 2-methyl-...... 03/07/86 03/07/96 78–87–5 1,2-Dichloropropane—Propane, 1,2-dichloro-...... 10/04/82 10/04/92 78–88–6 1-Propene, 2,3-dichloro-...... 6/1/87 12/19/95 78–93–3 Methyl ethyl ketone—2-Butanone ...... 10/04/82 10/04/92 78–97–7 Propanenitrile, 2-hydroxy-...... 6/1/87 12/19/95 78–99–9 Propane, 1,1-dichloro-...... 3/7/86 12/19/95 79–00–5 Ethane, 1,1,2-trichloro-...... 06/01/87 06/01/97 79–06–1 Acrylamide—2-Propenamide ...... 10/04/82 10/04/92 79–24–3 Nitroethane-Ethane, nitro-...... 4/13/89 12/19/95 79–94–7 Tetrabromobisphenol A—Phenol, 4,4′- ...... 06/20/85 06/20/95 (methylethylidene)bis[2,6-dibromo-. 80–05–7 Bisphenol A—Phenol, 4,4′-(1-methylethylidene)bis- ...... 06/28/84 06/28/94 80–15–9 Hydroperoxide, 1-methyl-1-phenylethyl...... 3/7/86 12/19/95 80–62–6 Methyl methacrylate—2-Propenoic acid, 2-methyl-, ...... 4/13/89 6/30/98 methyl ester. 84–65–1 Anthraquinone—9,10-Anthracenedione ...... 12/28/84 11/09/93 85–22–3 Pentabromoethylbenzene—Benzene, ...... 12/28/84 12/28/94 pentabromoethyl-. 85–68–7 Benzyl butyl phthalate—1,2-Benzenedicarboxylic ...... 04/29/83 04/29/93 acid, butyl phenylmethyl ester. 86–74–8 9H-Carbazole ...... 03/07/86 03/07/96 87–68–3 Hexachloro-1,3-butadiene—1,3-Butadiene, ...... 10/04/82 10/04/92 1,1,2,3,4,4-hexachloro-. 88–04–0 p-Chloro-m-xylenol-Phenol, 4-chloro-3,5-dimethyl-...... l4/13/89 12/19/95 90–30–2 N-Phenyl-1-naphthylamine ...... 9/30/91 12/19/95 90–42–6 [1,1′-Bicyclohexyl]-2-one ...... 06/01/87 11/09/93 91–08–7 Benzene, 1,3-diisocyanato-2-methyl-...... 6/1/87 12/19/95 91–20–3 Naphthalene ...... 06/01/87 06/01/97 91–58–7 Naphthalene, 2-chloro-...... 10/04/82 10/04/92 92–52–4 1,1′-Biphenyl ...... 04/29/83 04/29/93 92–69–3 [1,1′-Biphenyl]-4-ol ...... 6/1/87 12/19/95 92–84–2 10H-Phenothiazine ...... 06/01/87 06/01/97 92–87–5 [1,1′-Biphenyl]-4,4′-diamine ...... 06/01/87 06/01/97 95–14–7 1,2,3-Benzotriazole-1H-Benzotriazole ...... 4/13/89 12/19/95 95–47–6 o-Xylene—Benzene, 1,2-dimethyl- ...... 10/04/82 10/04/92 95–48–7 o-Cresol—Phenol, 2-methyl- ...... 10/04/82 10/04/92 95–49–8 2/Chlorotoluene—Benzene, 1-chloro-2-methyl-...... 04/29/83 04/29/93 95–53–4 Benzenamine, 2-methyl-...... 3/7/86 12/19/95 95–63–6 1,2,4-Trimethylbenzene—Benzene, 1,2,4-trimethyl-...... 04/29/83 04/29/93 96–18–4 Propane, 1,2,3-trichloro-...... 06/01/87 06/01/97 96–29–7 2-Butanone, oxime...... 12/15/86 12/19/95

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Effective CAS No. Substance Special exemptions date Sunset date

96–37–7 Methylcyclopentane—Cyclopentane, methyl-...... 06/20/85 11/09/93 97–18–7 Phenol, 2,2′-thiobis[4,6-dichloro- ...... 6/1/87 12/19/95 97–23–4 Phenol, 2,2′-methylenebis[4-chloro- ...... 6/1/87 12/19/95 97–88–1 Butyl methacrylate-2-Propenoic acid, 2-methyl-,butyl ...... 4/13/89 12/19/95 ester. 98–01–1 2-Furancarboxaldehyde ...... 06/01/87 06/01/97 98–06–6 Benzene, (1,1-dimethylethyl)-...... 6/1/87 12/19/95 98–09–9 Benzenesulfonyl chloride...... 3/7/86 12/19/95 98–51–1 p-tert-Butyltoluene—Benzene, 1-(1,1-dimethylethyl)-4- ...... 06/25/86 06/25/96 methyl-. 98–56–6 4-Chlorobenzotrifluoride—Benzene, 1-chloro-4- ...... 04/29/83 04/29/93 (trifluoromethyl)-. 98–73–7 p-tert-Butylbenzoic acid-Benzoic acid, 4-(1,1- ...... 6/25/86 12/19/95 dimethylethyl)-. 98–82–8 Cumene—Benzene, (1-methylethyl)-...... 12/28/84 12/28/94 98–83–9 Benzene, (1-methylethenyl)-...... 06/01/87 11/09/93 98–95–3 Nitrobenzene—Benzene, nitro-...... 10/04/82 10/04/92 100–02–7 p-Nitrophenol—Phenol, 4-nitro- ...... 4/13/89 6/30/98 100–40–3 4-Vinylcyclohexene ...... 1/11/90 11/09/93 100–41–4 Benzene, ethyl-...... 06/19/87 06/19/97 100–48–1 4-Pyridinecarbonitrile ...... 06/01/87 06/01/87 100–54–9 3-Pyridinecarbonitrile ...... 06/01/87 12/29/88 100–70–9 2-Pyridinecarbonitrile ...... 06/01/87 11/09/93 101–68–8 Benzene, 1,1′-methylenebis[4-isocyanato- ...... 06/01/87 06/01/97 101–77–9 Benzenamine, 4,4′-methylenebis- ...... 10/04/82 10/04/92 101–84–8 Diphenyl oxide—Benzene, 1,1′-oxybis- ...... 4/13/89 6/30/98 102–71–6 Triethanolamine-Ethanol, 2,2′,2″-nitrilotris- ...... 4/13/89 12/19/95 104–49–4 Benzene, 1,4-diisocyanato-...... 06/01/87 11/09/93 104–51–8 Benzene, butyl-...... 6/1/87 12/19/95 104–76–7 1-Hexanol, 2-ethyl-...... 6/1/87 12/19/95 105–60–2 2H-Azepin-2-one, hexahydro- ...... 06/01/87 06/01/97 106–42–3 p-Xylene—Benzene, 1,4-dimethyl- ...... 10/04/82 10/04/92 106–43–4 Benzene, 1-chloro-4-methyl-...... 6/1/87 12/19/95 106–44–5 p-Cresol—Phenol, 4-methyl- ...... 10/04/82 10/04/92 106–49–0 Benzenamine, 4-methyl-...... 03/07/86 03/07/96 106–50–3 p-Phenylenediamine—1,4-Benzenediamine ...... 10/04/82 10/04/92 106–51–4 Quinone—2,5-Cyclohexadiene-1,4-dione ...... 10/04/82 10/04/92 106–88–7 Oxirane, ethyl-...... 10/04/82 10/04/92 106–89–8 Oxirane, (chloromethyl)-...... 10/04/82 10/04/92 107–06–2 Ethane, 1,2-dichloro-...... 06/01/87 06/01/97 107–10–8 1-Propanamine ...... 3/7/86 12/19/95 107–19–7 2-Propyn-1-ol ...... 3/7/86 12/19/95 107–98–2 1-Methoxy-2-propanol—2-Propanol, 1-methoxy-...... 4/13/89 6/30/98 108–05–4 Vinyl acetate—Acetic acid ethenyl ester ...... 02/10/86 02/10/96 108–10–1 Methyl isobutyl ketone—2-Pentanone, 4-methyl- ...... 10/04/82 10/04/92 108–31–6 Maleic anhydride—2,5-Furandione...... 09/10/84 09/10/94 108–38–3 m-Xylene—Benzene, 1,3-dimethyl- ...... 10/04/82 10/04/92 108–39–4 m-Cresol—Phenol, 3-methyl- ...... 10/04/82 10/04/92 108–60–1 Propane, 2,2′-oxybis[1-chloro- ...... 6/1/87 12/19/95 108–67–8 1,3,5-Trimethylbenezene—Benzene, 1,3,5-trimethyl- ...... 02/13/84 02/13/94 108–86–1 Benzene, bromo-...... 6/1/87 12/19/95 108–88–3 Toluene—Benzene, methyl-...... 10/04/82 10/04/92 108–89–4 4-Methylpyridine—Pyridine, 4-methyl-...... 09/10/84 09/10/94 108–94–1 Cyclohexanone ...... 10/04/82 10/04/92 108–95–2 Phenol ...... 06/01/87 06/01/97 108–95–5 Thiophenol ...... 1/26/94 12/19/95 108–98–5 Benzenethiol ...... 03/07/86 03/07/96 108–99–6 3-Methylpyridine—Pyridine, 3-methyl-...... 09/10/84 09/10/94 109–06–8 2-Methylpyridine—Pyridine, 2-methyl-...... 09/10/84 09/10/94 109–77–3 Propanedinitrile ...... 3/7/86 12/19/95 109–87–5 Methane, Dimethoxy-...... 6/1/87 12/19/95 109–89–7 Ethanamine, N-ethyl- ...... 06/01/87 06/01/97 110–75–8 Ethene, (2-chloroethoxy)-...... 3/7/86 12/19/95 110–82–7 Cyclohexane ...... 12/19/85 12/19/95 110–86–1 Pyridine ...... 10/04/82 10/04/92 111–21–7 Ethylene bisoxyethylene diacetate—Ethanol, 2,2′]- ...... 01/13/84 12/29/88 [1,2-ethanediylbis(oxy)]bis-, diacetate. 111–40–0 Diethylenetriamine—1,2-Ethanediamine, N-(2- ...... 04/29/83 04/29/93 aminoethyl)-. 111–42–2 Diethanolamine—Ethanol, 2,2′-iminobis- ...... 4/13/89 6/30/98 111–69–3 Hexanedinitrile ...... 6/1/87 12/19/95 111–76–2 2-Butoxyethanol—Ethanol, 2-butoxy-...... 4/13/89 6/30/98 111–77–3 Diethylene glycol monomethyl ether-Ethanol, 2-(2- ...... 4/13/89 12/19/95 methoxyethoxy)-.

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Effective CAS No. Substance Special exemptions date Sunset date

111–90–0 Diethylene glycol monoethyl ether-Ethanol, 2-(2- ...... 4/13/89 12/19/95 ethoxyethoxy)-. 111–91–1 Ethane, 1,1′-[methylenebis(oxy)]bis[2-chloro- ...... 3/7/86 12/19/95 111–92–2 1-Butanamine, N-butyl-...... 6/1/87 12/19/95 112–35–6 Triethyleneglycol monomethyl ether—Ethanol, 2-[2- ...... 06/20/85 06/20/95 (2-methoxyethoxy)ethoxy]-. 112–50–5 Triethyleneglycol monoethyl ether—Ethanol, 2-[2-(2- ...... 06/20/85 06/20/95 ethoxyethoxy)ethoxy]-. 112–90–3 Oleylamine—9-Octadecen-1-amine, (Z)- ...... 01/13/84 01/13/94 115–28–6 Chlorendic acid—Bicyclo[2.2.1] hept-5-ene-2,3- ...... 04/29/83 01/13/86 dicarboxylic acid, 1,4,5,6,7,7-hexachloro-. 115–96–8 Ethanol, 2-chloro-, phosphate (3:1) ...... 12/16/88 11/09/93 118–79–6 2,4,6-Tribromophenol ...... 1/11/90 6/30/98 120–20–7 Anthracene ...... 06/01/87 06/01/97 120–32–1 2-Benzyl-4-chlorophenol-Phenol, 4-chloro-2- ...... 4/13/89 12/19/95 chlorophenol(phenyl methyl)-. 121–44–8 Ethanamine, N,N-diethyl- ...... 01/13/84 01/13/94 121–47–1 Benzenesulfonic acid, 3-amino- ...... 06/01/87 12/29/88 122–09–8 Benzeneethanamine, alpha,alpha-dimethyl-...... 3/7/86 12/19/95 122–66–7 Hydrazine, 1,2-diphenyl-...... 06/01/87 06/01/97 122–99–6 2-Phenoxyethanol—Ethanol, 2-phenoxy-...... 07/01/83 07/01/93 123–31–9 Hydroquinone—1,4-Benzenediol ...... 10/04/84 10/04/94 123–61–5 Benzene, 1,3-diisocyanato-...... 06/01/87 11/09/93 123–72–8 Butanal ...... 12/16/88 12/19/95 124–16–3 1-Butoxyethoxy-2-propanol-2-Propanol, 1-(2- ...... 4/13/89 12/19/95 butoxyethoxy)-. 124–17–4 2-(2-Butoxyethoxy)ethyl acetate—Ethanol, 2-(2- ...... 01/13/82 01/13/92 butoxyethoxy)-, acetate. 124–48–1 Methane, dibromochloro-...... 06/01/87 06/01/97 126–73–8 Phosphoric acid, tributyl ester ...... 06/18/86 06/18/96 126–99–8 Chloroprene—1,3-Butadiene, 2-chloro-...... 12/28/84 12/28/94 127–18–4 Ethene, tetrachloro-...... 06/01/87 06/01/97 128–39–2 Phenol, 2,6-bis(1,1-dimethylethyl)-...... 12/19/85 11/09/93 128–86–9 2,6-Anthracenedisulfonic acid, 4,8-diamino-9,10- ...... 12/21/87 11/09/93 dihydro-1,5-dihydroxy-9,10-dioxo-. 129–00–0 Pyrene ...... 06/01/87 06/01/97 131–17–9 Diallyl phthalate-1,2-Benzenedicarboxylic acid, di-2- ...... 4/13/89 12/19/95 propenyl ester. 135–98–8 Benzene, (1-methylpropyl)-...... 6/1/87 12/19/95 136–35–6 1-Triazene, 1,3-diphenyl-...... § 716.21(a)(5) 6/3/04 8/2/04 137–20–2 Soldium N-methyl-N-oleoyltaurine—Ethanesulfonic ...... 12/28/84 12/28/94 acid, 2-[methyl (1-oxo-9-octadecenyl)amino]-, sodium salt, (Z)-. 137–26–8 Thioperoxydicarbonic diamide, tetramethyl- ...... 6/1/87 12/19/95 139–25–3 Benzene, 1,1 1-methylenebis[4-isocyanato-3-methyl- ...... 06/01/87 11/09/93 140–08–9 Tris(2-chloroethyl)phosphite—Ethanol, 2-chloro-, ...... 04/29/83 01/13/86 phosphite (3:1). 140–66–9 4-(1,1,3,3-Tetramethylbutyl) phenol—Phenol, 4- ...... 01/30/83 12/29/88 (1,1,3,3-tetramethylbutyl)-. 140–88–5 Ethyl acrylate—2-Propenoic acid, ethyl ester ...... 4/13/89 6/30/98 141–79–7 Mesityl oxide—3-Penten-2-one, 4-methyl- ...... 10/04/82 10/04/92 142–28–9 Propane, 1,3,-dichloro-...... 3/7/86 12/19/95 142–84–7 1-Propanamine, N-propyl- ...... 03/07/86 12/5/90 143–22–6 Triethyleneglycol monobutyl ether—Ethanol, 2-[-2-(2- ...... 06/20/85 06/20/95 butoxyethoxy)ethoxy]-. 143–33–9 Sodium cyanide...... 10/29/90 12/19/95 149–30–4 Mercaptobenzothiazole—2(3H-Benzothiazolethione ...... 12/28/84 12/28/94 149–57–5 2-Ethylhexanoic acid—Hexanoic acid, 2-ethyl- ...... 06/28/84 06/28/94 306–83–2 Ethane, 2,2-dichloro-1,1,1-trifluoro...... 10/15/90 11/09/93 328–84–7 3,4-Dichlorobenzotrifluoride—Benzene, 1,2-dichloro- ...... 05/08/85 11/09/93 4-(trifluoromethyl)-. 354–33–6 Ethane, pentafluoro...... 10/15/90 11/09/93 357–57–3 Strychnidin-10-one, 2,3-dimethoxy-...... 3/7/86 12/19/95 428–59–1 Oxirane, trifluoro(trifluoromethyl)-...... 10/04/82 10/04/92 496–46–8 Imidazo[4,5-d]imidazole-2,5(1H,3H)-dione, tetrahydro- § 716.21(a)(1) ...... 6/3/04 8/2/04 472–41–3 Phenol, 4-(3,4-dihydro-2,2,4-trimethyl-2H-1- ...... 06/01/87 12/29/88 benzopyran-4-yl)-. 506–96–7 Acetyl bromide...... 6/1/87 12/19/95 526–73–8 1,2,3-Trimethylbenzene—Benzene, 1,2,3-trimethyl-...... 02/13/84 11/09/93 530–50–7 Hydrazine, 1,1-diphenyl-...... 6/1/87 12/19/95 534–07–6 2-Propanone, 1,3-dichloro-...... 6/1/87 12/19/95 540–54–5 Propane, 1-chloro-...... 6/1/87 12/19/95 540–84–1 Pentane, 2,2,4-trimethyl-...... 6/1/87 12/19/95

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Effective CAS No. Substance Special exemptions date Sunset date

542–75–6 1-Propene, 1,3-dichloro-...... 06/01/87 06/01/97 556–67–2 Octamethylcyclotetrasiloxane—Cyclotetrasiloxane, ...... 12/28/84 12/28/94 octamethyl-. 563–54–2 1-Propene, 1,2-dichloro-...... 03/07/86 12/29/88 563–58–6 1-Propene, 1,1-dichloro-...... 03/07/86 12/29/88 580–51–8 [1,1′-Biphenyl]-3-ol ...... 06/01/87 11/09/93 584–84–9 Benzene, 2,4-diisocyanato-1-methyl-...... 06/01/87 06/01/97 591–08–2 Acetamide, N-(aminothioxomethyl)-...... 3/7/86 12/19/95 594–20–7 Propane, 2,2-dichloro-...... 3/7/86 12/19/95 598–21–0 Acetyl bromide, bromo- ...... 6/1/87 12/19/95 598–31–2 2-Propanone, 1-bromo-...... 3/7/86 12/19/95 616–23–9 1-Propanol, 2,3-dichloro-...... 3/7/86 12/19/95 620–14–4 m-Ethyltoluene—Benzene, 1-ethyl-3-methyl- ...... 04/29/83 04/29/93 622–96–8 p-Ethyltoluene—Benzene, 1-ethyl-4-methyl- ...... 04/29/83 04/29/93 630–20–6 Ethane, 1,1,1,2-tetrachloro-...... 6/1/87 12/19/95 632–79–1 Tetrabromophthalic anhydride...... 1/11/90 12/19/95 637–92–3 Ethyl-tert-butyl ether § 716.20(b)(3) applies 12/28/94 6/30/98 646–06–0 1,3-Dioxolane ...... 01/03/83 01/03/93 677–21–4 Trifluoromethylethene—1-Propene, 3,3,3-trifluoro-...... 04/29/83 01/13/86 685–91–6 Acetamide, N,N-diethyl- ...... 06/01/87 11/09/93 692–42–2 Arsine, diethyl-...... 3/7/86 12/19/95 696–28–6 Arsonous dichloride, phenyl- ...... 3/7/86 12/19/95 757–58–4 Tetraphosphoric acid, hexaethyl ester ...... 3/7/86 12/19/95 811–97–2 Ethane, 1,1,2-tetrafluoro-...... 10/15/90 11/09/93 812–03–3 Propane, 1,1,1,2-tetrachloro-...... 6/1/87 12/19/95 822–06–0 Hexane, 1,6-diisocyanato-...... 6/1/87 12/19/95 828–00–2 1,3-Dioxan-4-ol, 2,6-dimethyl-, acetate ...... 6/1/87 12/19/95 930–22–3 Oxirane, ethenyl-...... 10/04/82 10/04/92 939–97–9 p-tert-Butylbenzaldehyde—Benzaldehyde, 4-(1,1- ...... 06/25/86 11/09/93 dimethylethyl)-. 994–05–8 Tert-amyl methyl ether § 716.20(b)(3) applies 12/28/94 06/30/98 1000–82–4 Methylolurea—Urea, (hydroxymethyl)-...... 07/01/83 07/01/93 1070–78–6 Propane, 1,1,1,3-tetrachloro-...... 6/1/87 12/19/95 1163–19–5 Decabromodiphenyl ether...... 1/11/90 06/30/98 1185–81–5 Dibutyltin bis(lauryl mercaptide)—Stannane, ...... 01/03/83 01/03/93 dibutylbis(dodecylthio). 1208–52–2 Benzenamine, 2-[(4-aminophenyl)methyl]-...... 06/01/87 11/09/93 1300–71–6 Phenol, dimethyl-...... 6/1/87 12/19/95 1309–64–4 Antimony trioxide...... 10/04/82 10/04/92 1321–38–6 Benzene, diisocyanatomethyl-(unspecified isomer) ...... 06/01/87 11/09/93 1321–64–8 Naphthalene, pentachloro-...... 10/04/82 10/04/92 1321–65–9 Naphthalene, trichloro-...... 10/04/82 10/04/92 1331–47–1 [1,1′-Biphenyl]-4,4′-diamino, dichloro- ...... 06/01/87 11/09/93 1333–41–1 Methyl pyridine—Pyridine, methyl- ...... 09/10/84 12/29/88 1335–87–1 Naphthalene, hexachloro-...... 10/04/82 10/04/92 1335–88–2 Naphthalene, tetrachloro-...... 10/04/82 10/04/92 1345–04–6 Antimony trisulfide...... 10/04/82 10/04/92 1464–53–5 2,2′-Bioxirane ...... 10/04/82 10/04/92 1634–04–4 Propane, 2-methoxy-2-methyl-...... 12/15/86 12/15/96 1649–08–7 Ethane, 1,2-dichloro-1,1-difluoro...... 10/15/90 12/19/95 1717–00–6 Ethane, 1,1-dichloro-1-fluoro-...... 10/15/90 11/09/93 1825–30–5 Naphthalene, 1,5-dichloro-...... 10/04/82 10/04/92 1825–31–6 Naphthalene, 1,4-dichloro-...... 10/04/82 10/04/92 1888–71–7 1-Propene, 1,1,2,3,3,3-hexachloro-...... 3/7/87 12/19/95 2050–69–3 Naphthalene, 1,2-dichloro-...... 10/04/82 10/04/92 2050–72–8 Naphthalene, 1,6-dichloro-...... 10/04/82 10/04/92 2050–73–9 Naphthalene, 1,7-dichloro-...... 10/04/82 10/04/92 2050–74–0 Naphthalene, 1,8-dichloro-...... 10/04/82 10/04/92 2050–75–1 Naphthalene, 2,3-dichloro-...... 10/04/82 10/04/92 2065–70–5 Naphthalene, 2,6-dichloro-...... 10/04/82 10/04/92 2198–75–6 Naphthalene, 1,3-dichloro-...... 10/04/82 10/04/92 2198–77–8 Naphthalene, 2,7-dichloro-...... 10/04/82 10/04/92 2234–13–1 Naphthalene, octachloro-...... 10/04/82 10/04/92 2536–05–2 Benzene, 1,1′-methylenebis[2-isocyanato- ...... 06/01/87 11/09/93 2556–36–7 Cyclohexane, 1,4-diisocyanato...... 06/01/87 11/09/93 2763–96–4 3(2H)-Isoxazolone, 5-(aminomethyl)-...... 3/7/86 2/19/95 2778–42–9 Benzene, 1,3-bis(1-isocyanato-1-methylethyl-...... 06/01/87 11/09/93 2861–02–1 2,6-Anthracenedisulfonic acid, 4,8-diamino-9,10- ...... 12/21/87 12/19/95 dihydro-1,5-dihydroxy-9,10-dioxo-, disodium salt 2873–89–0 Ethane, 2-chloro-1,1,1,2-tetrafluoro-...... 10/15/90 11/09/93 3083–25–8 Oxirane, (2,2,2-trichloroethyl)-...... 10/04/82 10/04/92 3173–72–6 Naphthalene, 1,5,-diisocyanato-...... 6/1/87 12/19/95 3194–55–6 Hexabromocyclododecane ...... 1/11/90 12/19/95

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Effective CAS No. Substance Special exemptions date Sunset date

3278–89–5 Benzene, 1,3,5-tribromo-2-(2-propenyloxy)-...... § 716.21(a)(4) ...... 6/3/04 8/2/04 3288–58–2 Phosphorodithioic acid, O,O-diethyl-S-methyl ester ...... 3/7/86 12/19/95 3296–90–0 1,3-Propanediol, 2,2-bis(bromomethyl)-...... 6/1/87 12/19/95 3319–31–1 Tris(2-ethylhexyl) trimellitate—1,2,4- ...... 01/03/83 01/03/93 Benzenetricarboxylic acid, tris(2-ethylhexyl)ester. 3322–93–8 1,2-Dibromo-4-(1,2-dibromoethyl) cyclohexane— ...... 06/28/84 12/29/88 Cyclohexane, 1,2-dibromo-4-(1,2-dibromoethyl)-. 3389–71–7 1,2,3,4,7,7-Hexachloronorbornadiene— ...... 01/13/84 01/13/94 Bicyclo[2.2.1]hepta-2,5-diene, 1,2,3,4,7,7- hexachloro-. 3618–72–2 Acetamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2- ...... 06/19/87 11/09/93 bromo-4,6-dinitrophenyl)azo]-4- methoxyphenyl]-. 3618-73–3 Acetamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2- ...... 06/19/87 11/09/93 chloro-4,6-dinitrophenyl)azo]-4-methoxyphenyl]-. 3956–55–6 Acetamide, N-[5-[bis[2-(acetyloxy)ethyl]-amino]-2-[(2- ...... 12/15/86 11/09/93 bromo-4,6-dinitrophenyl)azo]-4-ethoxyphenyl. 4098–71–9 Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)- ...... 06/01/87 06/01/97 1,3,3-trimethyl-. 4170–30–3 2-Butenal ...... 3/7/86 12/19/95 5124–30–1 Cyclohexane, 1,1′-methylenebis[4-isocyanato- ...... 06/01/87 06/01/97 5131–66–8 1-Butoxy-2-propanol-2-Propanol, 1-butoxy-...... 4/13/89 12/19/95 5344–82–1 Thiourea, (2-chlorophenyl)-...... 3/7/86 12/19/95 5873–54–1 Benzene, 1-isocyanato-2-[4- ...... 06/01/87 11/09/93 isocyanatophenyl)methyl]-. 6145–73–9 1-Propanol, 2-chloro-, phosphate (3:1) ...... 12/16/88 11/09/93 6247–34–3 2-Anthracenesulfonic acid, 4-[[4- ...... 12/21/87 11/09/93 (acetylamino)phenyl]amino]-1-amino-9,10-dihydro- 9,10-dioxo-. 6422–86–2 Bis(2-ethylhexyl) terephthalate—1,4- ...... 01/03/83 01/03/93 Benzenedicarboxylic acid, bis(2-ethylhexyl) ester. 6424–85–7 2-Anthracenesulfonic acid, 4-[[4- ...... 12/21/87 12/19/95 (acetylamino)phenyl]amino]- 1-amino-9,10-dihydro- 9,10-dioxo-, monosodium salt. 7320–37–8 Oxirane, tetradecyl-...... 10/04/82 10/04/92 7440–28–0 Thallium ...... 06/01/87 06/01/97 7440–36–0 Antimony ...... 10/04/82 10/04/92 7440–48–4 Cobalt ...... 06/01/87 06/01/97 7723–14–0 White phosphorus...... 04/12/93 06/30/98 9011–05–6 Urea, polymer with formaldehyde ...... § 716.20(b)(1) applies ...... 06/03/85 06/03/95 9016–87–9 Isocyanic acid, polymethylenepolyphenylene ester ...... 6/1/87 12/19/95 10347–54–3 Cyclohexane, 1,4-bis(isocyanatomethyl)-...... 06/01/87 06/01/87 10436–39–2 1-Propene, 1,1,2,3-tetrachloro-...... 6/1/87 12/19/95 12001–85–3 Naphthenic acids, zinc salts ...... 6/1/87 12/19/95 12185–10–3 White phosphorus...... 01/26/94 06/30/98 12217–79–7 9,10-Anthracenedione, 1,5-diamino-chloro-4,8- ...... 12/21/87 11/09/93 dihydroxy-. 13414–54–5 Methallyl 2-nitrophenyl ether—Benzene, 1-[(2-methyl- ...... 02/13/84 11/09/93 2-propenyl)oxy]-2-nitro-. 13414–55–6 7-Nitro-2,2-dimethyl-2,3-dihydro-benzofuran— ...... 02/13/84 02/13/94 Benzofuran, 2,3-dihydro-2,2-dimethyl-7-nitro-. 13674–84–5 2-Propanol, 1-chloro-, phosphate (3:1) ...... 12/16/88 11/09/93 13674–87–8 2-Propanol, 1,3-dichloro-, phosphate (3:1) ...... 12/16/88 12/19/95 15646–96–5 Hexane, 1,6-diisocyanato-2,4,4-trimethyl-...... 06/01/87 11/09/93 16691–43–3 3H-1,2,4-Triazole-3-thione, 5-amino-1,2-dihydro-...... § 716.21(a)(1) ...... 6/3/04 8/2/04 16938–22–0 Hexane, 1,6-diisocyanato-2,2,4-trimethyl-...... 06/01/87 11/09/93 17418–58–5 9,10-Anthracenedione, 1-amino-4-hydroxy-2- ...... 12/21/87 12/19/95 phenoxy-. 18495–30–2 Propane, 1,1,2,3-tetrachloro-...... 06/01/87 12/29/88 18633–25–5 Oxirane, tridecyl-...... 10/04/82 10/04/92 19660–16–3 2-Propenoic acid, 2,3-dibromopropyl ester ...... 06/01/87 12/29/88 21429–43–6 Acetamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2- ...... 06/19/87 11/09/93 chloro-4,6-dinitrophenyl)azo]-4-methoxyphenyl]-. 25168–06–3 Isopropyl phenol—Phenol, (1-methylethyl)- ...... 04/13/89 11/09/93 25168–21-2 Dibutyltin bis (isooctyl maleate)—2-Butenoic acid, ...... 01/03/83 01/03/93 4,4′-[(dibutylstannylene)bis(oxy)]bis-[4-oxo-, diisoctyl ester, (Z,Z)-. 25498–49–1 Tripropylene glycol monomethyl ether-Propanol, [2- ...... 4/13/89 12/19/95 (2-methoxy methylethoxy)methylethoxy]-. 25550–14–5 Benzene, ethylmethyl- (mixed isomers) ...... 04/29/83 04/29/93 25550–98–5 Phosphorous acid, diisodecyl phenyl ester ...... 12/19/85 12/19/95 25551–13–7 Trimethylbenzene—Benzene, trimethyl- (mixed iso- ...... 02/13/84 02/13/94 mers). 25640–78–2 Isopropyl biphenyl—1,1′-Biphenyl, (1-methylethyl)- ...... 06/28/84 11/09/93

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Effective CAS No. Substance Special exemptions date Sunset date

25852–70–4 Monobutyltin tris (isooctyl) mercapto-acetate—Acetic ...... 01/03/83 01/03/93 acid, 2,2′,2″-[(butylstannylidyne)tris(thio)]tris-, triisooctyl ester. 26447–40–5 Benzene, 1,1′-methylenebis[isocyanato- ...... 06/01/87 06/01/97 26471–62–5 Benzene, 1,3-diisocyanatomethyl-...... 06/01/87 06/01/97 26530–20–1 3(2H)-Isothiazolone, 2-octyl- ...... 06/01/87 12/29/88 26952–23–8 1-Propene, dichloro-...... 6/1/87 12/19/95 29091–20–1 Benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4- § 716.21(a)(2) ...... 6/3/04 8/2/04 (trifluoromethyl)-. 29385–43–1 Tolyl triazole-1H-Benzotriazole, methyl- ...... 4/13/89 12/19/95 32052–51–0 Isocyanic acid, trimethylcyclohexyl ester ...... 06/01/87 11/09/93 32534–81–9 Pentabromodiphenyl ether...... 1/11/90 06/30/98 32536–52–0 Octabromodiphenyl ether...... 1/11/90 06/30/98 32588–76–4 Ethylene Bis-(tetrabromophthalimide)...... 1/11/90 12/19/95 33125–86–9 Phosphoric acid, 1,2-ethanediyl tetrakis (2- ...... 12/16/88 11/09/93 chloroethyl) ester. 34590–94–8 Dipropylene glycol monomethyl ether—Propanol, (2- ...... 4/13/89 6/30/98 methoxymethylethoxy)-. 37853–59–1 1,2-Bis(tribromophenoxy) ethane...... 1/11/90 06/30/98 38661–72–2 Cyclohexane, 1,3-bis(isocyanatomethyl)-...... 06/01/87 11/09/93 41291–34–3 Ethylene(5,6-dibromonorbornane-2,3-dicarboximide) ...... 1/11/90 12/19/95 52907–07–0 Ethylene bis(5,6-dibromonorbornane-2,3- ...... 1/26/94 12/19/95 dicarboximide. 57137–10–7 Tribrominated polystyrene...... 1/11/90 12/19/95 61262–53–1 Ethylene bis(pentabromophenoxide)...... 1/11/90 12/19/95 61788–33–8 Terphenyl, chlorinated...... 10/04/82 12/29/88 61789–36–4 Calcium naphthenate—Naphthenic acids, calcium ...... 07/01/83 07/01/93 salts. 61789–51–3 Cobalt naphthenate—Naphthenic acids, cobalt salts ...... 07/01/83 07/01/93 61790–14–5 Lead naphthenate—Naphthenic acids, lead salts ...... 07/01/83 07/01/93 64742–95–6 Solvent naphtha (petroleum), light arom ...... 2/13/84 2/13/94 68081–84–5 Oxirane, mono[(C10–16-alkyloxy) methyl] derivatives ...... 10/04/82 10/04/92 68122–86–1 Imidazolium compounds, 4,5-dihydro-1-methyl-2- ...... 6/20/88 12/19/95 nortallow alkyl-1-(2-tallow amidoethyl), methyl sulfates. 68153-35–5 Ethanaminium, 2-amino-N-(2-aminoethyl-N-(2-hy- ...... 06/20/88 11/09/93 droxyethyl)-N-methyl-, N,N ′-ditallow acyl derivatives, methyl sulfates (salts). 68298–46–4 7-Amino-2,2-dimethyl-2,3-dihydrobenzofuran—7- ...... 02/13/84 12/29/88 Benzofuranamine,2,3-dihydro-2,2-dimethyl-. 68389–88–8 Poly(oxy-1,2-ethanediyl), a-[2-[bis(2- ...... 06/20/88 11/09/93 aminoethyl)methylammonio]ethyl]-w-hydroxy-, N,N ′-dicoco acyl derivatives, methyl sulfates (salts). 68389–89–9 Poly(oxy-1,2-ethanediyl), a-[2-[bis(2- ...... 06/20/88 11/09/93 aminoethyl)methylammonio]ethyl]-w-hydroxy-,N,N ′- bis(hydrogenated tallow acyl) derivatives, methyl sulfates (salts). 68410–69–5 Poly(oxy-1,2-ethanediyl), alpha-[2-[bis(2-aminoethyl) ...... 6/20/88 12/19/95 methylammonio]ethyl]-w-hydroxy,- N,N′-ditallow acyl derivatives, methyl sulfates (salts). 68413–04–7 Poly[oxy(methyl-1,2-ethanediyl)], a-[2-[bis(2- ...... 06/20/88 11/09/93 aminoethyl)methylammonio] methylethyl]-w-hydroxy-, N,N ′-ditallow acyl derivatives, methyl sulfates (salts). 68554–06–3 Poly(oxy-1,2-ethanediyl), a-[3-[bis(2- ...... 06/20/88 11/09/93 aminoethyl)methylammonio]-2-hydroxy-propyl]-w- hydroxy-, N-coco acyl derivatives, methyl sulfates (salts). 68611–64–3 Urea, reaction products with formaldehyde ...... § 716.20(b)(1) applies ...... 06/03/85 11/09/93 68928–76–7 Stannane, dimethylbis[(1-oxoneodecyl)oxy]-...... § 716.21(a)(3) ...... 6/3/04 8/2/04 69009–90–1 Diisopropyl biphenyl—1,1′-Biphenyl, bis(1- ...... 06/28/84 12/29/88 methylethyl)-. 70914–09–9 Poly(oxy-1,2-ethanediyl), a-[2-[bis(2- ...... 06/20/88 06/20/88 aminoethyl)methylammonio]ethyl]-w-hydroxy-, N,N ′-di[C14–18 acyl] derivatives, methyl sulfates (salts). 75790–84–0 Benzene, 2-isocyanato-4-[(4-isocyanato- ...... 06/01/87 11/09/93 phenyl)methyl]-1-methyl-. 75790–87–3 Benzene, 1-isocyanato-2-[(4-isocyanato-phenyl)thio]- ...... 06/01/87 11/09/93

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(b) [Reserved] Manufacturers, importers, and proc- (c) By category. The following cat- essors of any chemical substance with- egories are listed in alphabetical order. in a category are subject to the report- Chemical substances listed within a ing requirements of subpart A for that category are provided only as examples category, except when the sunset date of the category. All chemical sub- for the particular substance predates stances within a category are subject the sunset date for the category, or to all the provisions of part 716 for the when the exemption of § 716.20(b) of this time period from the effective date of part applies. the category until the sunset date.

CAS No. (ex- Category amples for cat- Special ex- Effective Sunset date egory) emptions date

Alkyl epoxides—including all noncyclic aliphatic hydrocarbons with one or more epoxy functional groups...... 10/4/82 12/29/88

CAS No. (ex- Category amples for cat- Special ex- Effective Sunset date egory) emptions date

R1=R 2=R 3 =R 4 =H or alkyl. Groups R 1–R 4 may contain one or more epoxide functions. Oxirane, decyl- ...... 2855–19–8 ...... 10/04/82 12/29/88 Oxirane, 2, 2 - dimethyl - ...... 558 – 30 – 5 ...... 10/04/82 12/29/88 Oxirane, 2, 3 - dimethyl - ...... 3266 – 23 – 7 ...... 10/04/82 12/29/88 Oxirane, dodecyl ...... 3234 – 28 – 4 ...... 10/04/82 12/29/88 Oxirane, heptadecyl - ...... 67860 – 04 – ...... 10/04/82 12/29/88 2 Oxirane, octyl- ...... 2404 – 44 – 6 ...... 10/04/82, 12/29/88 Oxirane, pentadecyl - ...... 22092 – 38 – ...... 10/04/82 12/29/88 2 Alkyl phthalates — all alkyl esters of 1, 2-benzenedicarboxylic acid ( ortho -phthalic acid)...... 10/04/82 10/04/92

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CAS No. (ex- Category amples for cat- Special ex- Effective Sunset date egory) emptions date

R1=R2=alkyl. 1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester ...... 117–81–7 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, bis(1-methylheptyl) ester ...... 131–15–7 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester ...... 84–69–5 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, 2-butoxy-2-oxyethyl butyl ester 85–70–1 ...... 10/04/82 01/13/86 1,2-Benzenedicarboxylic acid, butyl cyclohexyl ester ...... 84–64–0 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, butyl 2-ethylhexyl ester ...... 85–69–8 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, butyl octyl ester ...... 84–78–6 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, decyl hexyl ester ...... 25724–58–7 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, decyl octyl ester ...... 119–07–3 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, dibutyl ester ...... 84–74–2 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, dicyclohexyl ester ...... 84–61–7 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, diethyl ester ...... 84–66–2 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, dihexyl ester ...... 84–75–3 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, diisodecyl ester ...... 26761–40–0 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, diisononyl ester ...... 28553–12–0 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, diisooctyl ester ...... 27554–26–3 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, demethyl ester ...... 131–11–3 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, dinonyl ester ...... 84–76–4 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, dioctyl ester ...... 117–84–0 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, diundecyl ester ...... 119–06–2 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, isodecyl tridecyl ester ...... 3648–20–2 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, 2-ethylhexyl-8-methylnonyl ester ...... 89–13–4 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, hexyl isodecyl ester ...... 61702–81–6 ...... 10/04/82 10/04/92 1,2-Benzenedicarboxylic acid, isodecyl tridecyl ester ...... 61886–60–0 ...... 10/04/82 10/04/92 Alkyltin compounds...... 01/03/83 12/29/88 Dibutyltin S,S′-bis(isooctyl mercaptoacetate)—Acetic acid, 2,2′-[(dibutylstannylene)bis(thio)]bis-, diisooctyl ester ...... 25168–24–5 ...... 01/03/83 12/29/88 Dibutyltin S,S′-bis(isooctyl mercaptoacetate)—Acetic acid, 2,2′-[(dimethylstannylene)bis(thio)]bis-, diisooctyl ester ...... 26636–01–1 ...... 01/03/83 12/29/88 Mono methyltin tris(isooctylmercaptoacetate) Acetic acid, 2,2′,2″-[(methylstannylidyne)tris(thio)]tris-triisoacetyl ester .. 54849–38–6 ...... 01/03/83 12/29/88 Aniline and chloro-, bromo-, and/or nitroanilines...... 10/04/82 10/04/92 Benzenamine ...... 62–53–3 ...... 10/04/82 10/04/92 Benzenamine, 4-bromo- ...... 106–40–1 ...... 10/04/82 10/04/92 Benzenamine, 2-bromo-6-chloro-4-nitro- ...... 99–29–6 ...... 10/04/82 10/04/92 Benzenamine, 2-bromo-,4,6-dinitro- ...... 1817–73–8 ...... 10/04/82 10/04/92 Benzenamine, 2-chloro- ...... 95–51–2 ...... 10/04/82 10/04/92 Benzenamine, 3-chloro- ...... 108–42–9 ...... 10/04/82 10/04/92 Benzenamine, 4-chloro- ...... 106–47–8 ...... 10/04/82 10/04/92 Benzenamine, 2-chloro-4,6-dinitro- ...... 3531–19–9 ...... 10/04/82 10/04/92 Benzenamine, 4-chloro-2,6-dinitro- ...... 5388–62–5 ...... 10/04/82 10/04/92 Benzenamine, 3-chloro-, hydrochloride ...... 141–85–5 ...... 10/04/82 10/04/92 Benzenamine, 2-chloro-4-nitro- ...... 121-87-9 ...... 10/04/82 10/04/92 Benzenamine, 2-chloro-5-nitro- ...... 6283–25–6 ...... 10/04/82 10/04/92 Benzenamine, 4-chloro-2-nitro- ...... 89–63–4 ...... 10/04/82 10/04/92 Benzenamine, 4-chloro-3-nitro- ...... 635–22–3 ...... 10/04/82 10/04/92 Benzenamine, 2,6-dibromo-4-nitro- ...... 827–94–1 ...... 10/04/82 10/04/92 Benzenamine, 2,3-dichloro- ...... 608–27–5 ...... 10/04/82 10/04/92 Benzenamine, 2,4-dichloro- ...... 554–00–7 ...... 10/04/82 10/04/92 Benzenamine, 2,5-dichloro- ...... 95–82–9 ...... 10/04/82 10/04/92

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Benzenamine, 3,4-dichloro- ...... 95–76–1 ...... 10/04/82 10/04/92 Benzenamine, 3,5-dichloro- ...... 626–43–7 ...... 10/04/82 10/04/92 Benzenamine, 2,6-dichloro-4-nitro- ...... 99–30–9 ...... 10/04/82 10/04/92 Benzenamine, 2,4-dinitro- ...... 97–02–9 ...... 10/04/82 10/04/92 Benzenamine, 2-nitro- ...... 88–74–4 ...... 10/04/82 10/04/92 Benzenamine, 3-nitro- ...... 99–09–2 ...... 10/04/82 10/04/92 Benzenamine, 4-nitro- ...... 100–01–6 ...... 10/04/82 10/04/92 Benzenamine, 2,4,6-tribromo- ...... 147–82–0 ...... 10/04/82 10/04/92 Benzenamine, 2,4,6-trichloro- ...... 634–93–5 ...... 10/04/82 10/04/92 Aryl phosphates—phosphate esters of phenol or of alkyl-substituted phenols. Triaryl and mixed alkyl and aryl esters are included but trialkyl esters are excluded ...... 10/04/82 10/04/92

CAS No. (ex- Category amples for cat- Special ex- Effective Sunset date egory) emptions date

R1=phenyl, either unsubstituted or substituted with one or more alkyl or aralkyl groups R2=R3 alkyl; or phenyl, either unsubstituted or substituted with one or more alkyl or aralkyl groups Phenol, dimethyl-, phosphate (3:1) ...... 25155–23–1 ...... 10/04/82 10/04/92 Phenol, 4-(1,1-dimethylethyl)-, phosphate (3:1) ...... 78–33–1 ...... 10/04/82 10/04/92 Phosphoric acid, dibutyl phenyl ester ...... 2528–36–1 ...... 10/04/82 10/04/92 Phosphoric acid, diisodecyl phenyl ester ...... 51363–64–5 ...... 10/04/82 10/04/92 Phosphoric acid, (1,1-dimethylethyl) phenyl diphenyl ester .... 56803–37–3 ...... 10/04/82 10/04/92 Phosphoric acid, 2-ethylhexyl diphenyl ester ...... 1241–94–7 ...... 10/04/82 10/04/92 Phosphoric acid, isodecyl diphenyl ester ...... 29761–21–5 ...... 10/04/82 10/04/92 Phosphoric acid, (1-methylethyl)phenyl diphenyl ester ...... 28108–99–8 ...... 10/04/82 10/04/92 Phosphoric acid, methylphenyl diphenyl ester ...... 25444–49–5 ...... 10/04/82 10/04/92 Phosphoric acid, (1-methyl-l-phenylethyl)phenyl diphenyl ester ...... 34364–42–6 ...... 10/04/82 10/04/92 Phosphoric acid, triphenyl ester ...... 115–86–6 ...... 10/04/82 10/04/92 Phosphoric acid, tris(methylphenyl) ester ...... 1330–78–5 ...... 10/04/82 10/04/92 Phosphoric acid, tris(2-methylphenyl) ester ...... 78–30–8 ...... 10/04/82 10/04/92 Phosphoric acid, tris(3-methylphenyl) ester ...... 563–04–2 ...... 10/04/82 10/04/92 Phosphoric acid, tris(4-methylphenyl) ester ...... 78–32–0 ...... 10/04/82 10/04/92 Asbestos—asbestiform varieties of chrysolite (serpentine); crocidolite (riebeckite); amosite (cummingtonite—grunerite); anthophyllite; tremolite; and actinolite...... 10/04/82 10/04/92 Asbestos ...... 1332–21–4 ...... 10/04/82 10/04/92 Asbestiform minerals ...... 12001–29–5 ...... 10/04/82 10/04/92 Asbestiform minerals ...... 17068–78–9 ...... 10/04/82 10/04/92 Asbestiform minerals ...... 12172–73–5 ...... 10/04/82 10/04/92 Bisazobiphenyl dyes derived from benzidine and its congeners, ortho-toluidine (dimethylbenzidine) and dianisidine (dimethoxybenzidine)...... 10/04/82 10/04/92 Benoic acid, 2-[[2-amino-6-[[4′-[(-carboxy-4-hydroxphenyl) azo[-3,3′-dimethoxy[1,1′-biphenyl]-4-yl]azo]-5-hydroxy-7- sulfo-1-naphthalenylazo]-5-nitro-, trisodium salt ...... 6739–62–4 ...... 10/04/82 10/04/92

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Benzoic acid, 5-[[4′-[2-amino-8-hydroxy-6-sulfo-1- naphthalenyl) azo] [1,1′-biphenyl]-4-yl]-azo]-2-hydroxy-, disodium salt ...... 2429–84–7 ...... 10/04/82 10/04/92 Benzoic acid, 5-[[4′-[7-amino-1-hydroxy-3-sulfo-2- naphthalenyl)azo] [1,1′-biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt ...... 2429–82–5 ...... 10/04/82 10/04/92 Benzoic acid, 5-[[4′-[(1-amino-4-sulfo-2-naphthalenyl)azo] [1,1′-biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt ...... 2429–79–0 ...... 10/04/82 10/04/92 Benzoic acid, 5-[[4′-[[2,6-diamino-3-[[8-hydroxy-3,6-disulfo-7- [(4-sulfo-1-naphthalenyl)azo]-2-naphthalenyl]azo]-5- methylphenyl]azo] [1,1′-biphenyl]-4-yl]azo]-2-hydroxy-, tetrasodium salt ...... 2429–81–4 ...... 10/04/82 10/04/92 Benzoic acid, 5-[[4′-[(2,6-diamino-3-methyl-5- sulfophenyl)azo]-3,3′-dimethyl[1,1′-biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt ...... 6637–88–3 ...... 10/04/82 10/04/92 Benzoic acid, 5-[[4′-[[2,6-diamino-3-methyl-5-[(4- sulfophenyl)azo]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt ...... 2586–58–5 ...... 10/04/82 10/04/92 Benzoic acid, 5-[[4′-[[2,6-diamino-3-methyl-5-[(4- sulfophenyl)azo]phenyl]azo]1,1′-biphenyl]-4-yl]azo]-2-hydroxy-3-methly-, disodium salt ...... 6360–54–9 ...... 10/04/82 10/04/92 Benzoic acid, 5-[[4′-[[2,4-dihydroxy-3-[(4- sulfophenyl)azo]phenyl]azo] [1,1′-biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt ...... 2893–80–3 ...... 10/04/82 10/04/92 Benzoic acid, 3,3′-[(3,7-disulfo-1,5-naphthalenediyl)bis[azo(6-hydroxy-3,1-phenylene)azo[6(or 7)-sulfo-4,1- naphthalenediyl]azo[1,1′-biphenyl]-4,4′-diylazo]]bis[6-hydroxy-, hexasodium salt ...... 8014–91–3 ...... 10/04/82 10/04/92 [1,1′-Biphenyl]-4,1′-bis diazonium), 3,3′-dimethoxy- ...... 20282–70–6 ...... 10/04/82 10/04/92 Butanamide, N,N′-(3,3′-dimethyl [1,1′-biphenyl]-4,4′-diyl)bis[3- oxo- ...... 91–96–3 ...... 10/04/82 10/04/92 C.I. Direct Blue 218 ...... 10401–50–0 ...... 10/04/82 10/04/92 Cuprate(2-), [5-[[4′-[[2,6-dihydroxy-3-[(2-hydroxy-5- sulfophenyl)azo]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-2- hydroxybenzoato(4-)]-, disodium ...... 16071–86–6 ...... 10/04/82 10/04/92 Cuprate(3-), [μ-[7-[[3,3′-dihydroxy-4′-[[1-hydroxy-6- (phenylamino)-3-sulfo-2-naphthalenyl]azo] [1,1′-biphenyl]- 4-yl]azo]-8-hydroxy-1,6-naphthalenedisulfonato(7-)]]di-, trisodium ...... 6656–03–7 ...... 10/04/82 10/04/92 Cuprate(4-), [μ-[[6,6′-[3,3′-dihydroxy[1,1′-biphenyl]-4-4′- diyl)bis(azo)]bis[4-amino-5-hydroxy-1,3- naphthalendisulfonato]](8-)]]di-, tetrasodium ...... 16143–79–6 ...... 10/04/82 10/04/92 2-Naphthalenecarboxamide, N,N′-(3,3′-dimethoxy[1,1′- biphenyl]-4,4′-diyl)bis[3-hydroxy- ...... 91–92–9 ...... 10/04/82 10/04/92 1,3-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6-[[4′- [(2hydroxy-1-naphthalenyl)azo]-3,3′-dimethoxy[1,1′- biphenyl]-4-yl]azo]-, disodium salt ...... 2586–57–4 ...... 10/04/82 10/04/92 1,3-Naphthalenedisulfonic acid, 6,6′-[(3,3′-dimethoxy[1,1′- biphenyl]-4,4′diyl)bis(azo)]bis[4-amino-5-hydroxy-, tetrasodium salt ...... 2610–05–1 ...... 10/04/82 10/04/92 1,3-Naphthalenedisulfonic acid, 8-[[4′-[(4-ethoxyphenyl)azo] [1,1′-biphenyl]-4-yl]azo]-7-hydroxy-, disodium salt ...... 3530–19–6– ...... 10/04/82 10/04/92 1,3-Naphthalenedisulfonic acid, 8-[[4′-[4-ethoxyphenyl)azo]- 3,3′-dimethyl] [1,1′-biphenyl]-4-yl]azo]-7-hydroxy-, disodium salt ...... 6358–29–8 ...... 10/04/82 10/04/92 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4′-[[4-[[(4- methylphenyl) sulfonyl]oxy]phenyl]-azo] [1,1′-biphenyl]-4- yl]azo]-, disodium salt ...... 3567–65–5 ...... 10/04/82 10/04/92 2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4′-(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)-azo] [1,1′-biphenyl]-4-yl]azo]- 4-hydroxy-, trisodium salt ...... 2429–73–4 ...... 10/04/82 10/04/92 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4′-[(2,4-diamino- 5-methylphenyl)azo] [1,1′-biphenyl]-4-yl]azo]-5-hydroxy-6- (phenylazo)-, disodium salt ...... 2429–83–6 ...... 10/04/82 10/04/92 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4′-[(2,4- diaminophenyl)azo] [1,1′-biphenyl]-4-yl]azo] 5-hydroxy-6- (phenylazo)-, disodium salt ...... 1937–37–7 ...... 10/04/82 10/04/92 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6[[4′-[(4- hydroxyphenyl)azo] [1,1′-biphenyl]-4-yl]-azo]-3-[(4- nitrophenyl)azo]-, disodium salt ...... 4335–09–5 ...... 10/04/82 10/04/92

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2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[[4′-[(4- hydroxyphenyl)azo] [1,1′-biphenyl]-4-yl]azo)-6-(phenylazo)-, disodium salt ...... 3626–28–6 ...... 10/04/82 10/04/92 2,7-Naphthalenedisulfonic acid, 3,3′-[[1,1′-biphenyl]-4,4′- diylbis(azo)]bis[5-amino-4-hydroxy-, tetrasodium salt ...... 2602–46–2 ...... 10/04/82 10/04/92 2,7-Naphthalenedisulfonic acid, 3,3′-[(3,3′-dimethoxy[1,1′- biphenyl]-4,4′-diyl)bis(azo)]bis[5-amino-4-hydroxy-, tetrasodium salt ...... 2429–74–5 ...... 10/04/82 10/04/92 2,7-Naphthalenedisulfonic acid, 3,3′-[(3,3′-dimethyl-[1,1′- biphenyl]-4,4′-diyl)bis(azo)]bis[5-amino-4-hydroxy-, tetrasodium salt ...... 72–57–1 ...... 10/04/82 10/04/92 2,7-Naphthalenedisulfonic acid, 3,3′-[(3,3′-dimethyl-[1,1′- biphenyl]-4,4′-diyl)bis(azo)]bis-[4,5-dihydroxy-, tetrasodium salt ...... 2150–54–1 ...... 10/04/82 10/04/92 1-Naphthalenesulfonic acid, 3-[[4′[(6-amino-1-hydroxy-3- sulfo-2-naphthalenyl)azo]-3,3′-dimethoxy[1,1′-biphenyl]-4- yl]azo]-4-hydroxy-, disodium salt ...... 6449–35–0 ...... 10/04/82 10/04/92 1-Naphthalenesulfonic acid, 3,3′-[[1,1′-biphenyl]-4,4′-diyl-4,4′- diyl)bis(azo)]bis[(4-amino-,disodium salt ...... 573–58–0 ...... 10/04/82 10/04/92 1-Naphthalenesulfonic acid, 3,3′-[3,3′-dimethoxy-[1,1′- biphenyl]-4,4′-diyl)bis(azo)]bis[4-hydroxy-, disodium salt ..... 2429–71–2 ...... 10/04/82 10/04/92 1-Naphthalenesulfonic acid, 3,3′-[(3,3′dimethyl[1,1′-biphenyl]- 4,4′-diyl)bis(azo)]bis[4-amino-,disodium salt ...... 992–59–6 ...... 10/04/82 10/04/92 Chlorinated benzenes, mono-, di-, tri-, tetra-, and penta- ...... 10/04/82 10/04/92 Benzene, chloro- ...... 108–90–7 ...... 10/04/82 10/04/92 Benzene, 1,2-dichloro- ...... 95–50–1 ...... 10/04/82 10/04/92 Benzene, 1,3-dichloro- ...... 541–73–1 ...... 10/04/82 10/04/92 Benzene, 1,4-dichloro- ...... 106–46–7 ...... 10/04/82 10/04/92 Benzene, pentachloro- ...... 608–93–5 ...... 10/04/82 10/04/92 Benzene, 1,2,3,4-tetrachloro- ...... 634–66–2 ...... 10/04/82 10/04/92 Benzene, 1,2,3,5-tetrachloro- ...... 634–90–2 ...... 10/04/82 10/04/92 Benzene, 1,2,4,5-tetrachloro- ...... 95–94–3 ...... 10/04/82 10/04/92 Benzene, 1,2,3-trichloro- ...... 87–61–6 ...... 10/04/82 10/04/92 Benzene, 1,2,4-trichloro- ...... 120–82–1 ...... 10/04/82 10/04/92 Benzene, 1,3,5-trichloro- ...... 108–70–3 ...... 10/04/82 10/04/92 Chlorinated naphthalenes—chlorinated derivatives of naphthalene (empirical formula) C10HxCly where x=y=8...... 10/04/82 12/29/88 Naphthalene, chloro- ...... 25586–43–0 ...... 10/04/82 12/29/88 Naphthalene, chloro derivatives ...... 70776–03–3 ...... 10/04/82 12/29/88 Naphthalene, 1-chloro- ...... 90–13–1 ...... 10/04/82 12/29/88 Naphthalene, heptachloro- ...... 32241–08–0 ...... 10/04/82 12/29/88 Chlorinated paraffins—chlorinated paraffin oils and chlorinated paraffin waxes, with chlorine content of 35 percent through 70 percent by weight...... 10/04/82 10/04/92 Alkanes, chloro- ...... 61788–76–9 ...... 10/04/82 10/04/92

Alkanes, C6–18, chloro- ...... 68920–70–7 ...... 10/04/82 10/04/92 Paraffin waxes and hydrocarbon waxes, chlorinated ...... 63449–39–8 ...... 10/04/82 10/04/92 Ethyltoluenes—This category consists of ethyltoluene (mixed isomers) and the ortho (1,2-), meta (1,3-) and para (1,4-) isomers ...... 04/29/83 12/29/88 Benzene, 1-ethyl-2-methyl- ...... 611–14–3 ...... 04/29/83 12/29/88 Fluoroalkenes—This category is defined as fluroalkenes of the general formula: CnH2n-xFx where n equals 2 to 3 and X equals 1 to 6...... 04/29/83 04/29/93 Ethene, tetrafluoro- ...... 116–14–3 ...... 04/29/83 04/29/93 Ethene, trifluoro- ...... 359–11–5 ...... 04/29/83 01/13/86 1-Propene, 1,1,2,3,3,3-hexafluoro- ...... 116–15–4 ...... 04/29/83 04/29/93 Glycidol (oxiranemethanol) and its derivatives ...... 10/04/82 10/04/92

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R=H; alkyl, alkenyl or alkynyl; aryl; acyl. where R=alkyl, alkenyl, alkynyl, aryl, or acyl; any substituents or functional groups may be present with the alkyl, etc., groups 1,2-Cyclohexanedicarboxylic acid, bis(oxiranylmethyl) ester .. 5493–45–8 ...... 10/04/82 10/04/92 Disiloxane, 1,1,3,3-tetramethyl-1,3-bis[3- oxiranylmethoxy)propyl]- ...... 126–80–7 ...... 10/04/82 10/04/92 2,4-Imidazolidinedione, 5,5-dimethyl-3-[2- (oxiranylmethoxy)propyl]-1-(oxiranylmethyl)- ...... 32568–89–1 ...... 10/04/82 10/04/92 2,4-Imidazolidenedione, 3,3′-[2-(oxiranylmethoxy)-1,3- propanediyl]bis[5,5-dimethyl-1-(oxiranyl-methyl)- ...... 38304–52–8 ...... 10/04/82 10/04/92 Neodecanoic acid, oxiranylmethyl ester ...... 26761–45–5 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[1,4-butanediylbis(oxymethylene)]bis ...... 2425–79–8 ...... 10/04/82 10/04/92 Oxirane, (butoxymethyl)- ...... 2426–08–6 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[1,4-cyclohexanedilbis (methyleneoxymethylene)]bis- ...... 14228–73–0 ...... 10/04/82 10/04/92 Oxirane, [(2,4-dibromophenoxy)methyl]- ...... 20217–01–0 ...... 10/04/82 10/04/92 Oxirane, [(1,2-dibromopropoxy)methyl]- ...... 35243–89–1 ...... 10/04/82 10/04/92 Oxirane, [(1,1-dimethylethoxy)methyl]- ...... 7665–72–7 ...... 10/04/82 10/04/92 Oxirane, [[4-(1,1-dimethylethyl)phenoxy]methyl]- ...... 3101–60–8 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[(2,2-dimethyl-1,3- propanediyl)bis(oxymethylene)]bis- ...... 17557–23–2 ...... 10/04/82 10/04/92 Oxirane, [(dodecyloxy)methyl]- ...... 2461–18–9 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[1,2-ethanediylbis (oxymethylene)]bis- ...... 2224–15–9 ...... 10/04/82 10/04/92 Oxirane, 2,2′,2″,2′′′-[1,2-ethanediylidenetetrakis-(4,1- phenyleneoxymethylene)]tetrakis- ...... 7328–97–4 ...... 10/04/82 10/04/92 Oxirane, (ethoxymethyl)- ...... 4016–11–9 ...... 10/04/82 10/04/92 Oxirane, [[(2-ethylhexyl)oxy]methyl]- ...... 2461–15–6 ...... 10/04/82 10/04/92 Oxirane, [(hexadecyloxy)methyl]- ...... 15965–99–8 ...... 10/04/82 10/04/92 Oxirane, 2,2′,2″-[1,2,6-hexanetriyltris-(oxymethylene)]tris- ...... 68959–23–9 ...... 10/04/82 10/04/92 Oxirane, (methoxymethyl)- ...... 930–37–0 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[methylenebis(phenyleneoxymethylene)]bis- ..... 39817–09–9 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[methylenebis(2,1-phenyleneoxymethylene)]bis- 54208–63–8 ...... 10/04/82 10/04/92 Oxirane, [(1-methylethoxy)methyl]- ...... 4016–14–2 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[(1-methylethylidene)bis[4,1-phenyl-eneoxy[1- (butoxymethyl)-2,1-ethanediyl]oxymethylene]]bis- ...... 71033–08–4 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[1-methylethylidene) bis(4,1-phenyleneoxymethylene)]bis- ...... 1675–54–3 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)[bis-, homopolymer ...... 25085–99–8 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[(1-methylethylidene)bis[4,1-phenyleneoxy-3,1- propanediyloxy-4,1-phenylene(1-methylethylidene)-4,1- phenyleneoxymethylene]]bis- ...... 72319–24–5 ...... 10/04/82 10/04/92 Oxirane, [(methylphenoxy)methyl]- ...... 26447–14–3 ...... 10/04/82 10/04/92 Oxirane, [(2-methylphenoxy)methyl]- ...... 2210–79–9 ...... 10/04/82 10/04/92 Oxirane, [[4-(1-methyl-1-phenylethyl)phenoxy]-methyl]- ...... 61578–04–9 ...... 10/04/82 10/04/92 Oxirane, mono[C6-C12-alkyloxy)methyl]derivatives ...... 68987–80–4 ...... 10/04/82 10/04/92 Oxirane, mono[(C8-C12-alkyloxy)methyl]derivatives ...... 68609–96–1 ...... 10/04/82 10/04/92 Oxirane, mono[C10-C16-alkyloxy)methyl]derivatives ...... 68081–84–5 ...... 10/04/82 10/04/92 Oxirane, mono[(C10-C14-alkyloxy)methyl]derivatives ...... 68609–97–2 ...... 10/04/82 10/04/92 Oxirane, [(4-nitrophenoxy)methyl]- ...... 5255–75–4 ...... 10/04/82 10/04/92

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Oxirane, [(4-nonylphenoxy)methyl]- ...... 6178–32–1 ...... 10/04/82 10/04/92 Oxirane, [(9-octadecenyloxy)methyl]-, (Z)- ...... 60501–41–9 ...... 10/04/82 10/04/92 Oxirane, [(octadecyloxy)methyl]- ...... 16245–97–9 ...... 10/04/82 10/04/92 Oxirane, 2,2′-(oxiranylmethoxy)-1,3-phenylene]bis(methylene)]bis- ...... 13561–08–5 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[[[2-oxiranylmethyoxy) phenyl]methylene]bis(4,1-phenyl-eneoxymethylene)]bis- .... 67786–03–2 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[oxybis(methylene)]bis- ...... 2238–07–5 ...... 10/04/82 10/04/92 Oxirane, (phenoxymethyl)- ...... 122–60–1 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[1,3-phenylenebis (oxymethylene)]bis- ...... 2425–01–6 ...... 10/04/82 10/04/92 Oxirane, 2,2′-[1,4-phenylenebis (oxymethylene)]bis- ...... 101–90–6 ...... 10/04/82 10/04/92 Oxirane, 2,2′,21⁄4-[1,2,3-propanetriyl tris(oxymethylene)]tris- .. 13236–02–7 ...... 10/04/82 10/04/92 Oxirane, [(2-propenyloxy)methyl]- ...... 106–92–3 ...... 10/04/82 10/04/92 Oxirane, 2,2′,21⁄4-[propylidynetris (4,1- phenyleneoxymethylene)]tris- ...... 68517–02–2 ...... 10/04/82 10/04/92 Oxirane, [(tetradecyloxy)methyl]- ...... 38954–75–5 ...... 10/04/82 10/04/92 Oxiranecarboxylic acid, 3-methyl-3-phenyl-, ethyl ester ...... 77–83–8 ...... 10/04/82 10/04/92 Poly(oxy-1,2-ethanediyl),-a-[4-oxiranylmethyoxy)benzoyl]-w- [[4-oxiranylmethoxy)benzoyl]oxy]- ...... 69943–75–5 ...... 10/04/82 10/04/92 2-Propenoic acid, 2-methyl-, oxiranylmethyl ester ...... 106–91–2 ...... 10/04/82 10/04/92 2-Propenoic acid, oxiranylmethyl ester ...... 106–90–1 ...... 10/04/82 10/04/92 Silane, [(3-chloropropyl)(dimethoxy)[3- (oxiranylmethoxy)propyl]- ...... 71808–64–5 ...... 10/04/82 10/04/92 Silane, diethoxymethyl[3-(oxiranyl-methoxy)propyl]- ...... 2897–60–1 ...... 10/04/82 10/04/92 Silane, ethoxydimethyl[3-(oxiranyl-methoxy)propyl]- ...... 17963–04–1 ...... 10/04/82 10/04/92 Silane, trimethyoxy[3-(oxiranyl-methoxy)propyl]- ...... 2530–83–8 ...... 10/04/82 10/04/92 Tetrasiloxane, 1,1,1,3,5,7,7,7-octamethyl-3,5-bis[3- (oxiranylmethoxy)propyl]- ...... 69155–42–6 ...... 10/04/82 10/04/92 Trisiloxane, 1,1,1,3,5,5,5-heptamethyl-3-[3-(oxiranylmethoxy)propyl]- ...... 7422–52–8 ...... 10/04/82 10/04/92 Halogenated alkyl epoxides—halogenated noncyclic aliphatic hydrocarbons with one or more epoxy functional groups...... 10/04/82 12/29/88

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R1=X or CnH2n=1¥yXy(y=1 to 1n=1) ...... R2=H or X or CnH2n=1¥yXy(y=0 to 2n=1) ...... R3=H or X or CnH2n=1¥yXy(y=0 to 2n=1) ...... R4=H or X or CnH2n=1¥yXy(y=0 to 2n=1) ...... X=halogen. Groups R1–R4 may contain one or more expoxide functions. Lead and lead compounds ...... § 716.21 February April 28, (a)(8) 28, 2008 2008 Lead ...... 7439– 92 – 1 § 716.21 February April 28, (a)(8) 28, 2008 2008 Acetic acid, lead (2+) salt ...... 301 – 04 – 2 § 716.21 February April 28, (a)(8) 28, 2008 2008

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Carbonic acid, lead (2+) salt (1:1) ...... 598 – 63 – 0 § 716.21 February April 28, (a)(8) 28, 2008 2008 Lead chloride (PbCl 2 ) ...... 7758 – 95 – 4 § 716.21 (a) February April 28, (8) 28, 2008 2008 Chromic acid (H 2 Cr0 4 ), lead (2+) salt (1:1) ...... 7758 – 97 – 6 § 716.21 February April 28, (a)(8) 28, 2008 2008 Lead oxide (PbO 2 ) ...... 1309 – 60 – 0 § 716.21 February April 28, (a)(8) 28, 2008 2008 Oxirane, (2,2,3,3,4,4,5,5,6,6,7,7,7-tridecafluoroheptyl)- ...... 38565–52–5 ...... 10/04/82 12/29/88 Borate (1-), tetrafluoro-, lead (2+) (2:1) ...... 13814 – 96 – § 716.21 February April 28, 5 (a)(8) 28, 2008 2008 Phosphoric acid, lead (2+) salt (2:3) ...... 7446 – 27 – 7 § 716.21 February April 28, (a)(8) 28, 2008 2008 Silicic acid, lead salt, basic ...... 53466 – 66 – § 716.21 February April 28, 3 (a)(8) 28, 2008 2008 Octadecanoic acid, lead salt (1:?) ...... 7428 – 48– 0 § 716.21 February April 28, (a)(8) 28, 2008 2008 Sulfuric acid, lead salt (1:?), basic ...... 63653 – 42 – § 716.21 February April 28, 9 (a)(8) 28, 2008 2008 Oxirane, (bromomethyl)- ...... 3132–463–7 ...... 10/04/82 12/29/88 Oxirane, (2,2,3,3,4,4,5,5,6,6,7,7,7-tridecafluoroheptyl)- ...... 38565–52–5 ...... 10/04/82 12/29/88 Lead sulfide (PbS) ...... 1314 – 8 7 – 0 § 716.21 February April 28, (a)(8) 28, 2008 2008 Phenylenediamines (Benzenediamines). This category is defined as all nitrogen unsubstituted phenylenediamines and their salts with zero to two substitutents on the ring selected from the same of different members of the group of halo, nitro, hydroxy, hydroxy-lower alkoxy, lower-alkyl, and lower alkoxy. For this purpose, the term ‘‘lower’’ is defined as a group containing between one and four carbons...... 04/29/83 04/29/93 1,2-Benzenediamine ...... 95 – 54 – 5 ...... 4/29/83 4/29/93 1,3-Benzenediamine ...... 108 – 45 – 2 ...... 4/29/83 4/29/93 1,2 - Benzenediamine, 4-butyl- ...... 3663 – 23 – 8 ...... 4/29/83 12/29/88 1,2 - Benzenediamine, 4-butyl- ...... 95 – 83– 0 ...... 4/29/83 4/29/83 1,3-Benzenediamine, 4-chloro- ...... 5131–60–2 ...... 04/29/83 04/29/93 1,4-Benzenediamine, 2-chloro-, dihydrochloride ...... 615–46–3 ...... 04/29/83 12/29/88 1,2-Benzenediamine, 5-chloro-3-nitro- ...... 42389–30–0 ...... 04/29/83 12/29/88 1,2-Benzenediamine, 4-chloro-, sulfate (1:1) ...... 68459–98–3 ...... 04/29/83 12/29/88 1,3-Benzenediamine, 4-chloro-, sulfate (1:1) ...... 68239–80–5 ...... 04/29/83 12/29/88 1,4-Benzenediamine, 2-chloro-, sulfate ...... 6219–71–2 ...... 04/29/83 12/29/88 1,4-Benzenediamine, 2,5-dichloro- ...... 20103–09–7 ...... 04/29/83 12/29/88 1,2-Benzenediamine, dihydrochloride ...... 615–28–1 ...... 04/29/83 04/29/93 1,3-Benzenediamine, dihydrochloride ...... 541–69–5 ...... 04/29/83 04/29/93 1,4-Benzenediamine, dihydrochloride ...... 624–18–0 ...... 04/29/83 04/29/93 1,4-Benzenediamine, ethanedioate (1:1) ...... 62654–17–5 ...... 04/29/83 04/29/93 1,2-Benzenediamine, 4-ethoxy- ...... 1197–37–1 ...... 04/29/83 12/29/88 1,3-Benzenediamine, 4-ethoxy-dihydrochloride ...... 67801–06–3 ...... 04/29/83 12/29/88 1,3-Benzenediamine, 4-ethoxy-, sulfate (1:1) ...... 68015–98–5 ...... 04/29/83 12/29/88 1,3-Benzenediamine, ar-ethyl-ar-methyl- ...... 68966–84–7 ...... 04/29/83 12/29/88 1,4-Benzenediamine, 2-methoxy ...... 5307–02–8 ...... 04/29/83 04/29/93 1,2-Benzenediamine, 4-methoxy-, dihydrochloride ...... 614–94–8 ...... 04/29/83 12/29/88 1,3-Benzenediamine, 4-methoxy-, sulfate ...... 6219–67–6 ...... 04/29/83 12/29/88 1,3-Benzenediamine, 4-methoxy-, sulfate (1:1) ...... 39156–41–7 ...... 04/29/83 04/29/93 Benzenediamine, ar-methyl- ...... 25376–45–8 ...... 04/29/83 04/29/93 1,2-Benzenediamine, 3-methyl- ...... 2687–25–4 ...... 04/29/83 04/29/93 1,2-Benzenediamine, 4-methyl- ...... 496–72–0 ...... 04/29/83 04/29/93 1,3-Benzenediamine, 2-methyl- ...... 823–40–5 ...... 04/29/83 04/29/93 1,3-Benzenediamine, 4-methyl- ...... 95–80–7 ...... 04/29/83 04/29/93 1,3-Benzenediamine, 5-methyl- ...... 108–71–4 ...... 04/29/83 04/29/93 1,4-Benzenediamine, 2-methyl- ...... 95–70–5 ...... 04/29/83 04/29/93 1,4-Benzenediamine, 2-methyl-, dihydrochloride- ...... 615–45–2 ...... 04/29/83 04/29/93 1,4-Benzenediamine, 2-methyl-, sulfate ...... 6369–59–1 ...... 04/29/83 04/29/93 1,4-Benzenediamine, 2-methyl-, sulfate (1:1) ...... 615–50–9 ...... 04/29/83 04/29/93 1,2-Benzenediamine, 4-nitro- ...... 99–56–9 ...... 04/29/83 04/29/93 1,3-Benzenediamine, 4-nitro-, ...... 5131–58–8 ...... 04/29/83 12/29/88 1,3-Benzenediamine, 5-nitro-, ...... 5042–55–7 ...... 04/29/83 12/29/88 1,4-Benzenediamine, 2-nitro-, ...... 5307–14–2 ...... 04/29/83 04/29/93 1,2-Benzenediamine, 4-nitro-, dihydrochloride ...... 6219–77–8 ...... 04/29/83 12/29/88 1,4-Benzenediamine, 2-nitro-, dihydrochloride ...... 18266–52–9 ...... 04/29/83 12/29/88 1,2-Benzenediamine, 4-nitro-, sulfate (1:1) ...... 68239–82–7 ...... 04/29/83 12/29/88 1,4-Benzenediamine, 2-nitro-, sulfate (1:1) ...... 68239–83–8 ...... 04/29/83 12/29/88 1,3-Benzenediamine, sulfate (1:1) ...... 541–70–8 ...... 04/29/83 04/29/93

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1,4-Benzenediamine, sulfate (1:1) ...... 16245–77–5 ...... 04/29/83 04/29/93 Ethanol, 2-(2,4-diaminophenoxy)-, dihydrochloride ...... 66422–95–5 ...... 04/29/83 12/29/88 Phenol, 2,4-diamino-, dihydrochloride ...... 137–09–7 ...... 04/29/83 04/29/93 Phenol, 2,4-diamino-6-methyl- ...... 15872–73–8 ...... 04/29/83 12/29/88 Phenol, 2,4-diamino-6-methyl-, hydrochloride ...... 65879–44–9 ...... 04/29/83 12/29/88

(d) Listed members of categories. The chemical substances specifically listed following categories are listed in al- within a category are subject to all phabetical order with the chemical provisions of part 716 for the time pe- substances identified in each category riod from the effective date of the rule also listed alphabetically. Only those until the sunset date.

Special Exemp- Effective Category CAS No. tions Date Sunset Date

Aldehydes:. Acetaldehyde ...... 75–07–0 ...... 9/30/91 6/30/98 Acetaldehyde, chloro- ...... 107–20–0 ...... 9/30/91 6/30/98 Acetaldehyde, (1,3-dihydro-1,3,3-trimethyl-2H-indol-2- 84–83–3 ...... 9/30/91 6/30/98 ylidene). Acetaldehyde, trichloro- ...... 75–87–6 ...... 9/30/91 6/30/98 Benzaldehyde ...... 100–52–7 ...... 9/30/91 6/30/98 Benzaldehyde, 3-bromo- ...... 3132–99–8 ...... 9/30/91 6/30/98 Benzaldehyde, 4-butyl- ...... 1200–14–2 ...... 9/30/91 12/19/95 Benzaldehyde, 2-chloro- ...... 89–98–5 ...... 9/30/91 6/30/98 Benzaldehyde, 4-chloro- ...... 104–88–1 ...... 9/30/91 6/30/98 Benzaldehyde, 4-(diethylamino)- ...... 120–21–8 ...... 9/30/91 6/30/98 Benzaldehyde, 4-(diethylamino)-2-hydroxy- ...... 17754–90–4 ...... 9/30/91 6/30/98 Benzaldehyde, 2,4-dihydroxy- ...... 95–01–2 ...... 9/30/91 12/19/95 Benzaldehyde, 2,5-dimethoxy- ...... 93–02–7 ...... 9/30/91 6/30/98 Benzaldehyde, 3,4-dimethoxy- ...... 120–14–9 ...... 9/30/91 6/30/98 Benzaldehyde, (dimethylamino)- ...... 28602–27–9 ...... 9/30/91 12/19/95 Benzaldehyde, 4-(dimethylamino)- ...... 100–10–7 ...... 9/30/91 6/30/98 Benzaldehyde, 4-ethoxy- ...... 10031–82–0 ...... l9/30/91 12/19/95 Benzaldehyde, 3-ethoxy-4-hydroxy- ...... 121–32–4 ...... 9/30/91 6/30/98 Benzaldehyde, 2-hydroxy- ...... 90–02–8 ...... 9/30/91 6/30/98 Benzaldehyde, 4-hydroxy- ...... 123–08–0 ...... 9/30/91 12/19/95 Benzaldehyde, 4-hydroxy-3-methoxy- ...... 121–33–5 ...... 9/30/91 6/30/98 Benzaldehyde, 2-hydroxy-5-nitro- ...... 97–51–8 ...... 9/30/91 12/19/95 Benzaldehyde, 2-methoxy- ...... 135–02–4 ...... 9/30/91 12/19/95 Benzaldehyde, 4-methoxy- ...... 123–11–5 ...... 9/30/91 6/30/98 Benzaldehyde, methyl- ...... 1334–78–7 ...... 9/30/91 12/19/95 Benzaldehyde, 4-methyl- ...... 104–87–0 ...... 9/30/91 6/30/98 Benzaldehyde, 2-nitro- ...... 552–89–6 ...... 9/30/91 12/19/95 Benzaldehyde, 3-phenoxy- ...... 39515–51–0 ...... 9/30/91 6/30/98 Benzaldehyde, 4-(trifluoromethyl)- ...... 455–19–6 ...... 9/30/91 12/19/95 Benzeneacetaldehyde ...... 122–78–1 ...... 9/30/91 6/30/98 Benzeneacetaldehyde, alpha-methyl- ...... 93–53–8 ...... 9/30/91 12/19/95 Benzeneacetaldehyde, 4-methyl- ...... 104–09–6 ...... 9/30/91 12/19/95 Benzenepropanal, 4-(1,1-dimethylethyl)-.a.-methyl- ...... 80–54–6 ...... 9/30/91 6/30/98 Benzenepropanal, .a.-methyl-4-(1-methylethyl)- ...... 103–95–7 ...... 9/30/91 6/30/98 1,3-Benzodioxole-5-carboxaldehyde ...... 120–57–0 ...... 9/30/91 6/30/98 1,3-Benzodioxole-5-carboxaldehyde, 7-methoxy- ...... 5780–07–4 ...... 9/30/91 12/19/95 Butanal, 3-methyl- ...... 590–86–3 ...... 9/30/91 6/30/98 3-Cyclohexene-1-carboxaldehyde ...... 100–50–5 ...... 9/30/91 6/30/98 3-Cyclohexene-1-carboxaldehyde, dimethyl- ...... 27939–60–2 ...... 9/30/91 6/30/98 3-Cyclohexene-1-carboxaldehyde, 4-(4-hydroxy-4- 31906–04–4 ...... 9/30/91 6/30/98 methylpentyl)-. 3-Cyclohexene-1-carboxaldehyde, 1-methyl-4-(4-methyl- 52475–86–2 ...... 9/30/91 6/30/98 3-pentenyl)-. 3-Cyclohexene-1-carboxaldehyde, 1-methyl-4-(4- 66327–54–6 ...... 9/30/91 6/30/98 methylpentyl)-. 3-Cyclohexene-1-carboxaldehyde, 4-(4-methyl-3-pen- 37677–14–8 ...... 9/30/91 12/19/95 tenyl)-. 3-Cyclohexene-1-carboxaldehyde, 2,4,6-trimethyl- ...... 1423–46–7 ...... 9/30/91 12/19/95 3-Cyclopentene-1-acetaldehyde, 2,2,3-trimethyl- ...... 4501–58–0 ...... 9/30/91 6/30/98 Decanal ...... 112–31–2 ...... 9/30/91 6/30/98 4a(4H)-Dibenzofurancarboxaldehyde, 1,5a,6,9,9a,9b- 126–15–8 ...... 9/30/91 6/30/98 hexahydro-.

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Dodecanal ...... 112–54–9 ...... 9/30/91 6/30/98 Ethanedial ...... 107–22–2 ...... 9/30/91 6/30/98 Heptanal ...... 111–71–7 ...... 9/30/91 6/30/98 Heptanal, 2-(phenylmethylene)- ...... 122–40–7 ...... 9/30/91 6/30/98 5-Heptenal, 2,6-dimethyl- ...... 106–72–9 ...... 9/30/91 12/19/95 Hexanal, 2-ethyl- ...... 123–05–7 ...... 9/30/91 6/30/98 Hexanal, 3,5,5-trimethyl- ...... 5435–64–3 ...... 9/30/91 12/19/95 2-Hexenal ...... 505–57–7 ...... 9/30/91 12/19/95 Hexenal, 2-ethyl- ...... 26266–68–2 ...... 9/30/91 6/30/98 Indium Compounds: Acetic acid, indium(3+) salt ...... 25114–58–3 ... § 716.21(a)(6) 6/3/04 8/2/04 Indium ...... 7440–74–6 ..... § 716.21(a)(6) 6/3/04 8/2/04 Indium chloride (InCl3) ...... 10025–82–8 ... § 716.21(a)(6) 6/3/04 8/2/04 Indium hydroxide (In(OH)3) ...... 20661–21–6 ... § 716.21(a)(6) 6/3/04 8/2/04 Indium oxide (In2O3) ...... 1312–43–2 ..... § 716.21(a)(6) 6/3/04 8/2/04 Indium phosphide (InP) ...... 22398–80–7 ... § 716.21(a)(6) 6/3/04 8/2/04 Indium tin oxide ...... 50926–11–9 ... § 716.21(a)(6) 6/3/04 8/2/04 Sulfamic acid, indium(3+) salt ...... 66027–93–8 ... § 716.21(a)(6) 6/3/04 8/2/04 Sulfuric acid, indium(3+) salt (3:2) ...... 13464–82–9 ... § 716.21(a)(6) 6/3/04 8/2/04 1-Naphthalene carboxaldehyde ...... 66–77–3 ...... 9/30/91 12/19/95 Nonanal ...... 124–19–6 ...... 9/30/91 6/30/98 2,6-Octadienal, 3,7-dimethyl-, (E) ...... 141–27–5 ...... 9/30/91 12/19/95 2,6-Octadienal, 3,7-dimethyl-, (Z) ...... 106–26–3 ...... 9/30/91 12/19/95 Octanal ...... 124–13–0 ...... 9/30/91 6/30/98 Octanal, 3,7-dimethyl- ...... 5988–91–0 ...... 9/30/91 12/19/95 Octanal, 7-hydroxy-3,7-dimethyl- ...... 107–75–5 ...... 9/30/91 6/30/98 Octanal, 7-methoxy-3,7-dimethyl- ...... 3613–30–7 ...... 9/30/91 6/30/98 Octanal, 2-(phenylmethylene)- ...... 101–86–0 ...... 9/30/91 6/30/98 6-Octenal, 3,7-dimethyl- ...... 106–23–0 ...... 9/30/91 6/30/98 6-Octenal, 3,7-dimethyl-, (S)- ...... 5949–05–3 ...... 9/30/91 12/19/95 Pentanal ...... 110–62–3 ...... 9/30/91 6/30/98 Pentanedial ...... 111–30–8 ...... 9/30/91 6/30/98 1-Piperidinecarboxaldehyde ...... 2591–86–8 ...... 9/30/91 6/30/98 Propanal ...... 123–38–6 ...... 9/30/91 6/30/98 Propanal, 3-hydroxy-2,2-dimethyl- ...... 597–31–9 ...... 9/30/91 6/30/98 2-Propenal, 2-methyl- ...... 78–85–3 ...... 9/30/91 12/19/95 Propanal, 3-(methylthio)- ...... 3268–49–3 ...... 9/30/91 6/30/98 2-Propenal ...... 107–02–8 ...... 9/30/91 6/30/98 2-Propenal, 3- 4-(1,1-dimethylethyl)phenyl -2-methyl- .... 13586–68–0 ...... 9/30/91 6/30/98 2-Propenal, 3-(2-methoxyphenyl)- ...... 1504–74–1 ...... 9/30/91 6/30/98 2-Propenal, 2-methyl- ...... 78–85–3 ...... 9/30/91 6/30/98 2-Propenal, 2-methyl-3-phenyl- ...... 101–39–3 ...... 9/30/91 6/30/98 2-Propenal, 3-phenyl- ...... 104–55–2 ...... 9/30/91 6/30/98 2-Propenal, 3-phenyl-, monopentyl deriv...... 1331–92–6 ...... 9/30/91 6/30/98 2-Pyridinecarboxaldehyde ...... 1121–60–4 ...... 9/30/91 12/19/95 2-Thiophene carboxaldehyde ...... 98–03–3 ...... 9/30/91 12/19/95 Undecanal ...... 112–44–7 ...... 9/30/91 6/30/98 Undecanal, 2-methyl- ...... 110–41–8 ...... 9/30/91 6/30/98 9-Undecenal ...... 143–14–6 ...... 9/30/91 12/19/95 10-Undecenal ...... 112–45–8 ...... 9/30/91 6/30/98 Alkyl-, Chloro-, and Hydroxymethyl Diaryl Ethers:. Benzene, 1-(bromomethyl)-3-phenoxy- ...... 51632–16–7 ...... 04/12/93 06/30/98 Benzenemethanol, 3-phenoxy-, ...... 13826–35–2 ...... 04/12/93 06/30/98 Benzenemethanol, 3-phenoxy-, acetate ...... 50789–44–1 ...... 4/12/93 12/19/95 Benzene, 1-methyl-3-phenoxy- ...... 3586–14–9 ...... 04/12/93 06/30/98 Benzene, 1,1′-oxybis[dodecyl- ...... 69834–19–1 ...... 4/12/93 12/19/95 Benzene, 1,1,′-oxybis[methyl- ...... 28299–41–4 ...... 04/12/93 06/30/98 Benzene, 1,1′-oxybis[(1,1,3,3-tetramethylbutyl)- ...... 61702–88–3 ...... 4/12/93 12/19/95 Benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, ... 63734–62–3 ...... 04/12/93 06/30/98 Benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy], 72242–48–3 ...... 04/12/93 06/30/98 potassium salt. 1,1′-Biphenyl, phenoxy- ...... 28984–89–6 ...... 04/12/93 06/30/98 2-Chloro-1-(3-methylphenoxy)-4- 42874–96–4 ...... 04/12/93 06/30/98 (trifluoromethyl)benzene. 1,4-Diphenoxybenzene ...... 3061–36–7 ...... 4/12/93 12/19/95 Phenol, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, acetate 50594–77–9 ...... 04/12/93 06/30/98 Alkyl Phosphates:. Ethanol, 2-butoxy-, phosphate (3:1) ...... 78–51–3 ...... 10/29/90 12/19/95 Ethanol, 2-(2-butoxyethoxy)-, phosphate (3:1) ...... 7332–46–9 ...... 10/29/90 11/09/93 Phosphoric acid, bis(2-ethylhexyl) ester ...... 298–07–7 ...... 10/29/90 12/19/95 Phosphoric acid, dibutyl ester ...... 107–66–4 ...... 10/29/90 06/30/98 Phosphoric acid, didodecyl ester ...... 7057–92–3 ...... 10/29/90 11/09/93 Phosphoric acid, diisooctyl ester ...... 27215–10–7 ...... 10/29/90 11/09/93

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Phosphoric acid, dodecyl ester ...... 12751–23–4 ...... 10/29/90 11/09/93 Phosphoric acid, 2-ethylhexyl ester ...... 12645–31–7 ...... 10/29/90 11/09/93 Phosphoric acid, monobutyl ester ...... 1623–15–0 ...... 10/29/90 11/09/93 Phosphoric acid, mono(2-ethylhexyl)ester ...... 1070–03–7 ...... 10/29/90 11/09/93 Phosphoric acid, monohexyl ester ...... 3900–04–7 ...... 10/29/90 11/09/93 Phosphoric acid, monomethyl ester ...... 812–00–0 ...... 10/29/90 11/09/93 Phosphoric acid, mono(1-methylethyl)ester ...... 1623–24–1 ...... 10/29/90 11/09/93 Phosphoric acid, monooctyl ester ...... 3991–73–9 ...... 10/29/90 11/09/93 Phosphoric acid, monooctadecyl ester ...... 2958–09–0 ...... 10/29/90 11/09/93 Phosphoric acid, triethyl ester ...... 78–40–0 ...... 10/29/90 12/19/95 Phosphoric acid, tris(2-ethylhexyl) ester ...... 78–42–2 ...... 10/29/90 12/19/95 Phosphoric acid, tris(2-methylpropyl) ester ...... 126–71–6 ...... 10/29/90 11/09/93 Phosphorodichloridic acid, ethyl ester ...... 1498–51–7 ...... 10/29/90 11/09/93 Alkylphenols and Alkylphenol Ethoxyates:. tert-Butylphenol (mixed isomers) ...... 27178–34–3 ... § 716.20(b)(4) 3/29/96 6/30/98 applies 2-Butylphenol ...... 3180–09–4 ..... § 716.20(b)(4) 3/29/96 6/30/98 applies 2-tert-Butylphenol ...... 88–18–6 ...... § 716.20(b)(4) 3/29/96 6/30/98 applies 4-n-Butylphenol ...... 1638–22–8 ..... § 716.20(b)(4) 3/29/96 6/30/98 applies 4-sec-Butylphenol ...... 99–71–8 ...... § 716.20(b)(4) 3/29/96 6/30/98 applies 4-tert-Butylphenol ...... 98–54–4 ...... § 716.20(b)(4) 3/29/96 6/30/98 applies Decaethylene glycol 4-isoctylphenyl ether ...... 2315–66–4 ..... § 716.20(b)(4) 3/29/96 6/30/98 applies 4-Dodecylphenol ...... 104–43–8 ...... § 716.20(b)(4) 3/29/96 6/30/98 applies Dodecylphenol (mixed isomers) ...... 1331–57–3 ..... § 716.20(b)(4) 3/29/96 6/30/98 applies Dedecylphenol (mixed isomers) ...... 27193–86–8 ... § 716.20(b)(4) 3/29/96 6/30/98 applies Hexaethylene glycol 4-isoctylphenyl ether ...... 2497–58–7 ..... § 716.20(b)(4) 3/29/96 6/30/98 applies Isobutylphenol (mixed isomers) ...... 31195–95–6 ... § 716.20(b)(4) 3/29/96 6/30/98 applies Isononylphenol (mixed isomers) ...... 11066–49–2 ... § 716.20(b)(4) 3/29/96 6/30/98 applies 4-(1-Methylbutyl)phenol ...... 94–06–4 ...... § 716.20(b)(4) 3/29/96 6/30/98 applies (1-Methylheptyl)phenol (mixed isomers) ...... 27985–70–2 ... § 716.20(b)(4) 3/29/96 6/30/98 applies 4-(1-Methyloctyl)phenol ...... 17404–66–9 ... § 716.20(b)(4) 3/29/96 6/30/98 applies Nonylphenol (mixed isomers) ...... 1300–16–9 ..... § 716.20(b)(4) 3/29/96 6/30/98 applies 25154–52–3 ... § 716.20(b)(4) 3/29/96 6/30/98 applies 4-Nonylphenol ...... 104–40–5 ...... § 716.20(b)(4) 3/29/96 6/30/98 applies Branched 4-nonylphenol (mixed isomers) ...... 84852–15–3 ... § 716.20(b)(4) 3/29/96 6/30/98 applies 2-Octylphenol ...... 949–13–3 ...... § 716.20(b)(4) 3/29/96 6/30/98 applies 4-Octylphenol ...... 1806–26–4 ..... § 716.20(b)(4) 3/29/96 6/30/98 applies 4-Pentylphenol ...... 14938–35–3 ... § 716.20(b)(4) 3/29/96 6/30/98 applies 4-tert-Pentylphenol ...... 80–46–6 ...... § 716.20(b)(4) 3/29/96 6/30/98 applies Polyethylene glycol mono(octyl)phenyl ether ...... 9036–19–5 ..... § 716.20(b)(4) 3/29/96 6/30/98 applies Polyethylene glycol 4-(tert-octyl)phenyl ether ...... 9002–93–1 ..... § 716.20(b)(4) 3/29/96 6/30/98 applies Poly(oxy-1,2-ethanediyl), a-(octylphenyl)-w-hydroxy-, 68987–90–6 ... § 716.20(b)(4) 3/29/96 6/30/98 branched. applies 2-(1,1,3,3-Tetramethylbutyl)phenol ...... 3884–95–5 ..... § 716.20(b)(4) 3/29/96 6/30/98 applies (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) ...... 1322–69–6 ..... § 716.20(b)(4) 3/29/96 6/30/98 applies

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27193–28–8 ... § 716.20(b)(4) 3/29/96 6/30/98 applies 29932–96–5 ... § 716.20(b)(4) 3/29/96 6/30/98 applies 30105–54–5 ... § 716.20(b)(4) 3/29/96 6/30/98 applies 62744–41–6 ... § 716.20(b)(4) 3/29/96 6/30/98 applies 4-(2,2,3,3-Tetramethylbutyl)phenol ...... 54932–78–4 ... § 716.20(b)(4) 3/29/96 6/30/98 applies Brominated flame retardants:. Alkanes, C10-18, bromochloro- ...... 68955–41–9 ...... 10/29/90 12/19/95 Benzamide, 3,5-dibromo-N-(4-bromophenyl)-2-hydroxy- 87–10–5 ...... 10/29/90 12/19/95 Benzene, ethenyl-, homopolymer, brominated ...... 88497–56–7 ...... 10/29/90 11/09/93 Benzene, 1,1′-(1-methylethylidene)bis (3,5-dibromo-4-(2- 25327–89–3 ...... 10/29/90 11/09/93 propenyloxy)-. Benzene, pentabromomethyl- ...... 87–83–2 ...... 10/29/90 12/19/95 Cyclohexane, 1,2,3,4,5-pentabromo-6-chloro- ...... 87–84–3 ...... 10/29/90 12/19/95 Cyclohexane, tetrabromodichloro- ...... 30554–72–4 ...... 10/29/90 12/19/95 Cyclohexane, tribromotrichloro- ...... 30554–73–5 ...... 10/29/90 12/19/95 Ethanol, 2,2′-((1-methylethylidene)bis ((2,6-dibromo-4,1- 4162–45–2 ...... 10/29/90 12/19/95 phenylene)oxy)) bis-. Ethene, bromo- ...... 593–60–2 ...... 10/29/90 06/30/98 Phenol, 2,4-dibromo- ...... 615–58–7 ...... 10/29/90 12/19/95 Phenol, 2,4(or 2,6)-dibromo-,homopolymer ...... 69882–11–7 ...... 10/29/90 12/19/95 1-Propanol, 2,3-dibromo- ...... 96–13–9 ...... 10/29/90 12/19/95 1-Propanol, 2,2-dimethyl-,tribromo deriv ...... 36483–57–5 ...... 10/29/90 12/19/95 2-Propenoic acid,(1-methylethylidene)bis (2,6-dibromo- 55205–38–4 ...... 10/29/90 12/19/95 4,1-phenylene) ester. Chloroalkyl phosphates:. 2,2-Bis(chloromethyl)-1,3-propanediyltetrakis(2- 38051–10–4 ...... 6/14/93 12/19/95 chloroethyl) phosphate. 2-Chloro-1-methylethylbis(2-chloropropyl) phosphate- .... 76649–15–5 ...... 6/14/93 12/19/95 1,2-Ethanediyl tetrakis(2-chloro-1-methylethylene) phos- 34621–99–3 ...... 6/14/93 12/19/95 phate. Oxydi-2,1-ethanediyltetrakis(2-choloroethyl) phosphate .. 53461–82–8 ...... 6/14/93 12/19/95 Cyanoacrylates:. 2-Propenoic acid, 2-cyano-, methyl ester ...... 137–05–3 ...... 1/26/94 12/19/95 2-Propenoic acid, 2-cyano-, isobutyl ester ...... 1069–55–2 ...... 1/26/94 12/19/95 2-Propenoic acid, 2-cyano-3,3-diphenyl-, 2-ethylhexyl 6197–30–4 ...... 1/26/94 12/19/95 ester. 2-Propenoic acid, 2-cyano-, butyl ester ...... 6606–65–1 ...... 1/26/94 12/19/95 2-Propenoic acid, 2-cyano-, ethyl ester ...... 7085–85–0 ...... 1/26/94 12/19/95 2-Propenoic acid, 2-cyano-, 2-propenyl ester ...... 7324–02–9 ...... 1/26/94 12/19/95 2-Propenoic acid, 2-cyano-, 1-methylethyl ester ...... 10586–17–1 ...... 1/26/94 12/19/95 2-Propenoic acid, 2-cyano-, ethoxy ethyl ester ...... 21982–43–4 ...... 1/26/94 12/19/95 2-Propenoic acid, 2-cyano-, 2,2,2-trifluoromethyl ester ... 23023–91–8 ...... 1/26/94 12/19/95 2-Propenoic acid, 2-cyano-, 2-methoxyethyl ester ...... 27816–23–5 ...... 1/26/94 12/19/95 Ethanaminium, 2-[[2-cyano-3-[4-(diethylamino)phenyl]-1- 64992–16–1 ...... 1/26/94 12/19/95 oxo-2-propenyl]oxy]-N,N,N-trimethyl-, chloride. Indium Compounds: ...... Acetic acid, indium(3+) salt ...... 25114–58–3 ... § 716.21(a)(6) 6/3/04 8/2/04 Indium ...... 7440–74–6 ..... § 716.21(a)(6) 6/3/04 8/2/04 Indium chloride (InCl3) ...... 10025–82–8 ... § 716.21(a)(6) 6/3/04 8/2/04 Indium hydroxide (In(OH)3) ...... 20661–21–6 ... § 716.21(a)(6) 6/3/04 8/2/04 Indium oxide (In2O3) ...... 1312–43–2 ..... § 716.21(a)(6) 6/3/04 8/2/04 Indium phosphide (InP) ...... 22398–80–7 ... § 716.21(a)(6) 6/3/04 8/2/04 Indium tin oxide ...... 50926–11–9 ... § 716.21(a)(6) 6/3/04 8/2/04 Sulfamic acid, indium(3+) salt ...... 66027–93–8 ... § 716.21(a)(6) 6/3/04 8/2/04 Sulfuric acid, indium(3+) salt (3:2) ...... 13464–82–9 ... § 716.21(a)(6) 6/3/04 8/2/04 IRIS Chemicals:. 3,4-Dimethylphenol ...... 95–65–8 ...... 9/30/91 12/19/95 2,4-Dinitrophenol ...... 51–28–5 ...... 9/30/91 12/19/95 Isocyanates:. Acetic acid, isocyanato-, ethyl ester ...... 2949–22–6 ...... 10/29/90 11/09/93 Benzene, bis(isocyanatomethyl)- ...... 25854–16–4 ...... 10/29/90 11/09/93 Benzene, 1-bromo-4-isocyanato- ...... 2493–02–9 ...... 10/29/90 11/09/93 Benzene, 1-chloro-3-isocyanato- ...... 2909–38–8 ...... 10/29/90 11/09/93 Benzene, 1-chloro-4-isocyanato- ...... 104–12–1 ...... 10/29/90 06/30/98 Benzene, 1,2-dichloro-4-isocyanato- ...... 102–36–3 ...... 10/29/90 06/30/98 Benzene, 1,3-dichloro-5-isocyanato- ...... 34893–92–0 ...... 10/29/90 11/09/93 Benzene, 1,1′-(diisocyanatomethylene)bis- ...... 10031–75–1 ...... 10/29/90 11/09/93 Benzene, isocyanato- ...... 103–71–9 ...... 10/29/90 06/30/98

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Benzene, 2-isocyanato-1,3-bis(1-methylethyl)- ...... 28178–42–9 ...... 10/29/90 11/09/93 Benzene, 2-isocyanato-1,3-dimethyl-, ester ...... 28556–81–2 ...... 10/29/90 11/09/93 Benzene, 1-isocyanato-2-methyl- ...... 614–68–6 ...... 10/29/90 11/09/93 Benzene, 1-isocyanato-4-methyl- ...... 622–58–2 ...... 10/29/90 11/09/93 Benzene, 1-isocyanato-4-nitro- ...... 100–28–7 ...... 10/29/90 11/09/93 Benzene, 1-isocyanato-3-(trifluoromethyl)- ...... 329–01–1 ...... 10/29/90 06/30/98 Benzene, 1,1′,1″-methylidynetris(4-isocyanato- ...... 2422–91–5 ...... 10/29/90 11/09/93 Butane, 1-isocyanato- ...... 111–36–4 ...... 10/29/90 06/30/98 Cyclohexane, 2-heptyl-3,4-bis (9-isocyanatononyl)-1- 68239–06–5 ...... 10/29/90 11/09/93 pentyl-. Cyclohexane, isocyanato- ...... 3173–53–3 ...... 10/29/90 11/09/93 1,3-Diazetidine-2,4-dione, 1,3-bis(3-isocyanato 26747–90–0 ...... 10/29/90 11/09/93 methylphenyl)-. Ethane, isocyanato- ...... 109–90–0 ...... 10/29/90 12/19/95 Imidodicarbonic diamide, N,N′-2-tris(6-isocyanatohexyl)- 4035–89–6 ...... 10/29/90 11/09/93 Methane, isocyanato- ...... 624–83–9 ...... 10/29/90 12/19/95 Octadecane, 1-isocyanato- ...... 112–96–9 ...... 10/29/90 11/09/93 Phenol, 4-isocyanato-, phosphorothioate (3:1) (ester) .... 4151–51–3 ...... 10/29/90 11/09/93 Propane, 1-isocyanato- ...... 110–78–1 ...... 10/29/90 11/09/93 1-Propene, 3-isocyanato- ...... 1476–23–9 ...... 10/29/90 11/09/93 2-Propenoic acid, 2-methyl-, 2- isocyanatoethyl ester .... 30674–80–7 ...... 10/29/90 12/19/95 2-Propenoic acid, 2-methyl-2-(((((5-isocyanato-1,3,3- 73597–26–9 ...... 10/29/90 11/09/93 trimethylcyclohexyl)methyl)amino) carbonyl)oxy)ethyl ester. 1,3,5,-Triazine-2,4,6(1H.3H.5H-trione, 1,3,5-tris(3- 26603–40–7 ...... 10/29/90 11/09/93 isocyanatomethylphenyl)-. Methyl ethylene glycol ethers and esters:. Ethylene glycol monomethy ether acrylate ...... 3121–61–7 ...... 1/26/94 12/19/95 Tetraethylene glycol monomethyl ether ...... 23783–42–8 ...... 1/26/94 12/19/95 OSHA Chemicals in Need of Dermal Absorption Testing:. Amitrole ...... 61-82-5 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies n-Amyl acetate ...... 628–63–7 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies o-Anisidine ...... 90-04-0 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Benzyl chloride ...... 100-44-7 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies sec-Butyl acetate ...... 105–46–4 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies tert-Butyl acetate ...... 540–88–5 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies sec-Butyl alcohol ...... 78–92–2 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies tert-Butyl alcohol ...... 75–65–0 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies t-Butylcatechol ...... 98-29-3 ...... § 716.20(b)(3) 8/4/95 6/30/98 and (b)(4) apply o-sec-butylphenol ...... 89–72–5 ...... 3/11/94 6/30/98 Camphor ...... 76–22–2 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies Carbon disulfide ...... 75-15-0 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Catechol ...... 120-80-9 ...... § 716.20(b)(3) 8/4/95 6/30/98 and (b)(4) apply a-Chloroacetophenone ...... 532–27–4 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies Chlorobenzene ...... 108-90-7 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies o-Chlorotoluene ...... 95-49-8 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Cyclohexene ...... 110–83–8 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies Cyclohexanol ...... 108-93-0 ...... § 716.20(b)(3) 8/4/95 6/30/98 and (b)(4) apply Cyclopentadiene ...... 542-92-7 ...... § 716.20(b)(3) 8/4/95 6/30/98 and (b)(4) apply Cyclopentane ...... 287–92–3 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies Diacetone alcohol ...... 123-42-2 ...... § 716.20(b)(3) 8/4/95 6/30/98 and (b)(4) apply Dibutyl phosphate ...... 107–66–4 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies

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1,2-Dichloroethylene ...... 540-59-0 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Dicylcopentadiene ...... 77-73-6 ...... § 716.20(b)(3) 8/4/95 6/30/98 and (b)(4) apply Dimethyl acetamide ...... 127-19-5 ...... § 716.20(b)(3) 8/4/95 6/30/98 and (b)(4) apply Dimethylaniline ...... 121-69-7 ...... § 716.20(b)(3) 8/4/95 6/30/98 and (b)(4) apply Dimethyl sulfate ...... 77-78-1 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies m-Dinitrobenzene ...... 99-65-0 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies o-Dinitrobenzene ...... 528-29-0 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies p-Dinitrobenzene ...... 100–25–4 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies 2,4-Dinitrotoluene ...... 121-14-2 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Diphenylamine ...... 122-39-4 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Disulfiram ...... 97–77–8 ...... § 716.20(b)(3) 1/26/94 1/26/94 applies Ethyl bromide ...... 74-96-4 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Ethyl ether ...... 60–29–7 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies Heptane (n-Heptane) ...... 142–82–5 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies Indene ...... 95-13-6 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Isoamyl acetate ...... 123–92–2 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies N-Isopropylaniline ...... 768-52-5 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies p-Methoxyphenol ...... 150-76-5 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Methyl acetate ...... 79–20–9 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies Methylcyclohexane ...... 108–87–2 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies Methyl formate ...... 107–31–3 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies Methyl isoamyl ketone ...... 110-12-3 ...... § 716.20(b)(3) 8/4/95 6/30/98 and (b)(4) apply p-Nitroaniline ...... 100-01-6 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies p-Nitrochlorobenzene ...... 100-00-5 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies 1-Nitropropane ...... 108–03–2 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies 2-Nitropropane ...... 79-46-9 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies m-Nitrotoluene ...... 99-08-1 ...... § 716.20(b)(3) 8/4/95 6/30/98 and (b)(4) apply o-Nitrotoluene ...... 88-72-2 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies p-Nitrotoluene ...... 99-99-0 ...... § 716.20(b)(3) 8/4/95 6/30/98 and (b)(4) apply Nonane ...... 111–84–2 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies Pentane ...... 109–66–0 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies Phenylhydrazine ...... 100-63-0 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Propylene glycol dinitrate ...... 6423-43-4 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Sodium bisulfite ...... 7631–90–5 ..... § 716.20(b)(3) 1/26/94 6/30/98 applies Sodium metabisulfite ...... 7681–57–4 ..... § 716.20(b)(3) 1/26/94 6/30/98 applies Tetrahydrofuran ...... 109-99-9 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies

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m-Toluidine ...... 108-44-1 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Vinylidene chloride ...... 75-35-4 ...... § 716.20(b)(3) 8/4/95 6/30/98 and (b)(4) apply Vinyl toluene ...... 25013-15-4 .... § 716.20(b)(3) 3/11/94 6/30/98 applies p-Xylene ...... 106–42–3 ...... § 716.20(b)(3) 1/26/94 6/30/98 applies Xylidine ...... 1300-73-8 ...... § 716.20(b)(3) 3/11/94 6/30/98 applies Propylene glycol ethers and esters:. Dipropylene glycol ...... 110–96–5 ...... 1/26/94 12/19/95 Dipropylene glycol butyl ether ...... 29911–28–2 ...... 1/26/94 12/19/95 Dipropylene glycol monomethyl ether acetate ...... 88917–22–0 ...... 1/26/94 12/19/95 1-(2-Methoxy-1-methylethoxy)-2-propanol ...... 20324–32–7 ...... 1/26/94 12/19/95 Methoxy-1-propanol ...... 28677–93–2 ...... 1/26/94 12/19/95 1-Phenoxy-2-propanol ...... 770–35–4 ...... 1/26/94 12/19/95 Propylene glycol monobutyl ether ...... 29387–86–8 ...... 1/26/94 12/19/95 Propylene glycol monomethyl ether acetate ...... 108–65–6 ...... 1/26/94 12/19/95 Propylene glycol mono-tert-butyl ether ...... 57018–52–7 ...... 1/26/94 12/19/95 Tripropylene glycol diacrylate ...... 42978–66–5 ...... 1/26/94 12/19/95 Tripropylene glycol methyl ether ...... 20324–33–8 ...... 1/26/94 12/19/95 Siloxanes:. Cyclopolydimethylsiloxane ...... 69430–24–6 ... 10/12/93 06/30/98 Decamethylcyclopentasiloxane ...... 541–02–6 ...... 10/12/93 06/30/98 Decamethyltetrasiloxane ...... 141–62–8 ...... 10/12/93 06/30/98 Dimethyldiphenylsiloxane ...... 68083–14–7 ... 10/12/93 06/30/98 Dimethylhydropolylsiloxane ...... 68037–59–2 ... 10/12/93 06/30/98 Dimethylmethyl 3,3,3-trifluoropropyl siloxane ...... 115361-68-7 .. 10/12/93 06/30/98 Dimethylmethylvinylsiloxane ...... 67762–94–1 ... 10/12/93 06/30/98 Dimethylpolysiloxanes ...... 68037–74–1 ... § 716.20(b)(2) 10/12/93 06/30/98 applies Dimethyl silicones and siloxanes ...... 63148–62–9 ... 10/12/93 06/30/98 Dimethyl silicones and siloxane, reaction products with 67762–90–7 ... § 716.20(b)(2) 10/12/93 06/30/98 silica. applies Docosamethylcycloundecasiloxane ...... 18766–38–6 ... § 716.20(b)(2) 10/12/93 06/30/98 applies Docosamethyldecasiloxane ...... 556–70–7 ...... § 716.20(b)(2) 10/12/93 06/30/98 applies Dodecamethylcyclohexasiloxane ...... 540–97–6 ...... 10/12/93 06/30/98 Dodecamethylpentasiloxane ...... 141–63–9 ...... 10/12/93 06/30/98 Dotetracontamethyleicosasiloxane ...... 150027-00-2 .. § 716.20(b)(2) 10/12/93 06/30/98 applies Dotriacontamethylcyclohexadecasiloxane ...... 150026-95-2 .. § 716.20(b)(2) 10/12/93 06/30/98 applies Dotriacontamethylpentadecasiloxane ...... 2471–11–6 ..... § 716.20(b)(2) 10/12/93 06/30/98 applies Eicosamethylcyclodecasiloxane ...... 18772–36–6 ... § 716.20(b)(2) 10/12/93 06/30/98 applies Eicosamethylnonasiloxane ...... 2652–13–3 ..... § 716.20(b)(2) 10/12/93 06/30/98 applies Hexacosamethylcyclotridecasiloxane ...... 23732–94–7 ... § 716.20(b)(2) 10/12/93 06/30/98 applies Hexacosamethyldodecasiloxane ...... 2471–08–1 ..... § 716.20(b)(2) 10/12/93 06/30/98 applies Hexadecamethylcyclooctasiloxane ...... 556–68–3 ...... § 716.20(b)(2) 10/12/93 06/30/98 applies Hexadecamethylheptasiloxane ...... 541–01–5 ...... § 716.20(b)(2) 10/12/93 06/30/98 applies Hexamethylcyclotrisiloxane ...... 541–05–9 ...... 10/12/93 06/30/98 Hexamethyldisilazane ...... 999–97–3 ...... 10/12/93 06/30/98 Hexamethyldisiloxane ...... 107–46–0 ...... 10/12/93 06/30/98 Hexatriacontamethylcyclooctadecasiloxane ...... 23523–12–8 ... § 716.20(b)(2) 10/12/93 06/30/98 applies Hexatriacontamethylheptadecasiloxane ...... 18844–04–7 ... § 716.20(b)(2) 10/12/93 06/30/98 applies Methylpolysiloxane ...... 9004–73–3 ..... 10/12/93 06/30/98 Methylvinylcyclosiloxane ...... 2554–06–5 ..... 10/12/93 06/30/98 Siloxanes and silicones, di-Me, hydroxy-terminated ...... 70131-67-8 .... § 716.20(b)(2) 10/12/93 06/30/98 applies Octacosamethylcyclotetradecasiloxane ...... 149050-40-8 .. § 716.20(b)(2) 10/12/93 06/30/98 applies Octacosamethyltridecasiloxane ...... 2471–09–2 ..... § 716.20(b)(2) 10/12/93 06/30/98 applies

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Octadecamethylcyclononasiloxane ...... 556–71–8 ...... § 716.20(b)(2) 10/12/93 06/30/98 applies Octadecamethyloctasiloxane ...... 556–69–4 ...... § 716.20(b)(2) 10/12/93 06/30/98 applies Octamethyltrisiloxane ...... 107–51–7 ...... 10/12/93 06/30/98 Octaphenylcyclotetrasiloxane ...... 546–56–5 ...... 10/12/93 06/30/98 Octatriacontamethylcyclononadecasiloxane ...... 150026-97-4 .. § 716.20(b)(2) 10/12/93 06/30/98 applies Octatriacontamethyloctadecasiloxane ...... 36938–52–0 ... § 716.20(b)(2) 10/12/93 06/30/98 applies Polymethyloctadecylsiloxane ...... not available .. § 716.20(b)(2) 10/12/93 06/30/98 applies Tetracontamethylcycloeicosasiloxane ...... 150026-98-5 .. § 716.20(b)(2) 10/12/93 06/30/98 applies Tetracontamethylnonadecasiloxane ...... 150026-99-6 .. § 716.20(b)(2) 10/12/93 06/30/98 applies Tetracosamethylcyclododecasiloxane ...... 18919–94–3 ... § 716.20(b)(2) 10/12/93 06/30/98 applies Tetracosamethylundecasiloxane ...... 107–53–9 ...... § 716.20(b)(2) 10/12/93 06/30/98 applies Tetradecamethylcycloheptasiloxane ...... 107–50–6 ...... § 716.20(b)(2) 10/12/93 06/30/98 applies Tetradecamethylhexasiloxane ...... 107–52–8 ...... § 716.20(b)(2) 10/12/93 06/30/98 applies Tetramethylcyclotetrasiloxane ...... 2370–88–9 ..... 10/12/93 06/30/98 Tetramethyldivinyldisiloxane ...... 2627–95–4 ..... 10/12/93 06/30/98 Tetratriacontamethylcycloheptadecasiloxane ...... 150026-96-3 .. 10/12/93 06/30/98 Tetratriacontamethylhexadecasiloxane ...... 36938–50–8 ... § 716.20(b)(2) 10/12/93 06/30/98 applies Triacontamethylcyclopentadecasiloxane ...... 23523–14–0 ... § 716.20(b)(2) 10/12/93 06/30/98 applies Triacontamethyltetradecasiloxane ...... 2471–10–5 ..... § 716.20(b)(2) 10/12/93 06/30/98 applies Trifluoropropylmethylcyclotrisiloxane ...... 2374–14–3 ..... 10/12/93 06/30/98

Substantially produced chemicals in need of subchronic tests:. Acetoacetanilide ...... 102–01–2 ...... 9/30/91 12/19/95 4-(Acetylamino)benzenesulfonyl chloride ...... 121–60–8 ...... 9/30/91 6/30/98 2-(2-Aminoethoxy)-ethanol ...... 929–06–6 ...... 6/30/92 6/30/98 7-Amino-4-hydroxy-2-naphthalenesulfonic acid ...... 87–02–5 ...... 9/30/91 12/19/95 Ammonium carbamate ...... 1111–78–0 ...... 9/30/91 12/19/95 1,3-Benzenedisulfonic acid ...... 98–48–6 ...... 9/30/91 12/19/95 Bis(2-ethylhexyl)-2-butenedioate ...... 142–16–5 ...... 9/30/91 12/19/95 Bromamine acid ...... 116–81–4 ...... 9/30/91 12/19/95 Butyric anhydride ...... 106–31–0 ...... 9/30/91 12/19/95 Ethanol, 2-(2-ethoxyethoxy)-, acetate ...... 112–15–2 ...... 9/30/91 6/30/98 1,2-Dichlorobutane ...... 616–21–7 ...... 9/30/91 12/19/95 3,4-Dichlorobutene ...... 760–23–6 ...... 9/30/91 12/19/95 3,4-Dichloronitrobenzene ...... 99–54–7 ...... 9/30/91 6/30/98 1,3-Dicyanobenzene ...... 626–17–5 ...... 9/30/91 6/30/98 Diethylene glycol dimethyl ether ...... 111–96–6 ...... 9/30/91 6/30/98 4-Ethoxynitrobenzene ...... 100–29–8 ...... 9/30/91 6/30/98 2-Ethylanthraquinone ...... 84–51–5 ...... 9/30/91 12/19/95 Hexa(methoxymethyl) melamine ...... 3089–11–0 ...... 9/30/91 6/30/98 3-Hydroxy-2-naphthoic acid ...... 92–70–6 ...... 9/30/91 12/19/95 Isobutyl acrylate ...... 106–63–8 ...... 9/30/91 12/19/95 Isophthaloyl chloride ...... 9–63–8 ...... 9/30/91 12/19/95 4-Methyl-2-nitro-phenol ...... 119–33–5 ...... 9/30/91 6/30/98 2-(4-Morpholinyldithio)-benzothiazole ...... 95–32–9 ...... 9/30/91 12/19/95 Naphthalenedicarboxylic anhydride ...... 81–84–5 ...... 9/30/91 6/30/98 1-Naphthol ...... 90–15–3 ...... 9/30/91 12/19/95 p,p′-Oxybis(benzenesulfonylhydrazide) ...... 80–51–3 ...... 9/30/91 6/30/98 2,4-Pentanedione ...... 123–54–6 ...... 9/30/91 12/19/95 Perfluoro-N-hexane ...... 355–42–0 ...... 9/30/91 12/19/95 Perfluorotributylamine ...... 311–89–7 ...... 9/30/91 12/19/95 Propanoic anhydride ...... 123–62–6 ...... 9/30/91 12/19/95 Quinacridone ...... 1047–16–1 ...... 9/30/91 12/19/95 Terephthaloyl chloride ...... 100–20–9 ...... 9/30/91 ...... Trichloromethanesulfenyl chloride ...... 594–42–3 ...... 9/30/91 6/30/98 Triethylene glycol bis(2-ethylhexanoate) ...... 94–28–0 ...... 9/30/91 12/19/95 Sulphones:. 2-Amino-4-[(2-hydroxyethyl) sulfonyl]phenol ...... 17601–96–6 ...... 9/30/91 12/19/95

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2-Amino-4-(methylsulfonyl)phenol ...... 98–30–6 ...... 9/30/91 12/19/95 2-[(6-Amino-2-naphthalenyl) sulfonyl]ethanol ...... 52218–35–6 ...... 9/30/91 12/19/95 2-[(3-Aminophenyl)sulfonyl]ethanol ...... 5246–57–1 ...... 9/30/91 12/19/95 Bisphenol S ...... 80–09–1 ...... 9/30/91 12/19/95 3-(Decyloxy)tetrahydrothiophene 1,1-dioxide ...... 18760–44–6 ...... 9/30/91 12/19/95 4,4′-Diaminodiphenyl sulfone ...... 80–08–0 ...... 9/30/91 12/19/95 4-[4-[(2,6-Dichloro-4-nitrophenyl)azo]phenyl] 17741–62–7 ...... 9/30/91 12/19/95 thiomorpholine, 11,1-dioxide. 1-(Diiodomethyl)sulfonyl-4-methyl benzene ...... 20018–09–1 ...... 9/30/91 12/19/95 Dimethylsulfone ...... 67–71–0 ...... 9/30/91 12/19/95 Diphenylsulfone ...... 127–63–9 ...... 9/30/91 12/19/95 3-[N-Ethyl-4-[[6-(methylsulfonyl)-2-benzothiazolyl]azo]- 16588–67–3 ...... 9/30/91 12/19/95 m-toluidino]propionitrile. 1,1′-[Methylenebis(sulfonyl)]bis-2-chloroethane ...... 41123–59–5 ...... 9/30/91 12/19/95 2,2′-[Methylenebis(sulfonyl)]bisethanol ...... 41123–69–7 ...... 9/30/91 12/19/95 1,1′-[Methylenebis(sulfonyl)]bisethene ...... 3278–22–6 ...... 9/30/91 12/19/95 6-Methylsulfonyl)-2-benzothiazolamine ...... 17557–67–4 ...... 9/30/91 12/19/95 2-[(3-Nitrophenyl)sulfonyl]ethanol ...... 41687–30–3 ...... 9/30/91 12/19/95 1,1′-[Oxybis(methylenesulfonyl)]bis-2-chloroethane ...... 53061–10–2 ...... 9/30/91 12/19/95 2,2′-[Oxybis(methylenesulfonyl)] bisethanol ...... 36724–43–3 ...... 9/30/91 12/19/95 1,1′-[Oxybis(methylenesulfonyl)] bisethene ...... 26750–50–5 ...... 9/30/91 12/19/95 4-[[4-(Phenylmethoxy)phenyl]sulfonyl] phenol ...... 63134–33–8 ...... 9/30/91 12/19/95 4-Phenylthiomorpholine, 1,1-dioxide ...... 17688–68–5 ...... 9/30/91 12/19/95 Sulfolane ...... 126–33–0 ...... 9/30/91 12/19/95 3-Sulfolene ...... 77–79–2 ...... 9/30/91 12/19/95 Sulfonyl bis(4-chlorobenzene) ...... 80–07–9 ...... 9/30/91 12/19/95 2,2′-Sulfonyl bisethanol ...... 2580–77–0 ...... 9/30/91 12/19/95 Voluntary HPV Challenge Program orphan (unsponsored) chemicals: Acetaldehyde, reaction products with formaldehyde, by- 68442–60–4 ... § 716.21(a)(7) September November products from. 29, 2006 28, 2006 Acetamide, 2,2-dichloro-N,N-di-2-propenyl- ...... 37764–25–3 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Acid chlorides, tallow, hydrogenated ...... 68955–37–3 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Alkanes, chloro ...... 61788–76–9 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Alkenes, C>10 .alpha.- ...... 64743–02–8 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Amides, coco, N-[3-(dimethylamino)propyl], alkylation 70851–08–0 ... § 716.21(a)(7) September November products with sodium 3-chloro-2- 29, 2006 28, 2006 hydroxypropanesulfonate. Amides, tall-oil fatty, N,N-di-Me ...... 68308–74–7 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Anthracene oil ...... 90640–80–5 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Aromatic hydrocarbons, C8, o-xylene-lean ...... 68650–36–2 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Aromatic hydrocarbons, C9–16, biphenyl deriv.-rich ...... 68955–76–0 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Barium, carbonate nonylphenol complexes ...... 68515–89–9 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzaldehyde, 3-bromo- ...... 3132–99–8 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzaldehyde, 3-phenoxy- ...... 39515–51–0 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzaldehyde, 4-(1,1-dimethylethyl)- ...... 939–97–9 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzenamine, 2,6-diethyl-N-methylene- ...... 35203–08–8 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzenamine, 2-ethyl-6-methyl-N-methylene- ...... 35203–06–6 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzenamine, 3-(trifluoromethyl)- ...... 98–16–8 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzenamine, N,N-dimethyl- ...... 121–69–7 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzenamine, N-phenyl-4-[[4-(phenylamino)phenyl][4- 2152–64–9 ..... § 716.21(a)(7) September November (phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]-, 29, 2006 28, 2006 monohydrochloride. Benzene, (2-chloro-1,1-dimethylethyl)- ...... 515–40–2 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzene, 1-(bromomethyl)-3-phenoxy- ...... 51632–16–7 ... § 716.21(a)(7) September November 29, 2006 28, 2006

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Benzene, 1,1’-[1,2-ethanediylbis(oxy)]bis- ...... 104–66–5 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzene, 1,1’-oxybis-, tetrapropylene derivs...... 119345–02–7 § 716.21(a)(7) September November 29, 2006 28, 2006 Benzene, 1,2-dimethyl-3-nitro- ...... 83–41–0 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzene, 1-bromo-4-fluoro- ...... 460–00–4 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzene, 1-chloro-2,4-dinitro- ...... 97–00–7 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzene, 1-chloro-4-(trichloromethyl)- ...... 5216–25–1 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzene, 1-chloro-4-(trifluoromethyl)- ...... 98–56–6 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzene, 1-methoxy-4-methyl- ...... 104–93–8 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzene, chloromethyl- ...... 25168–05–2 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzene, ethenylethyl- ...... 28106–30–1 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzene, ethylenated ...... 68987–41–7 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzene, mixed with toluene, dealkylation product ...... 68953–80–0 ... § 716.21(a)(7) September November 29, 2006 28, 2006 1,3-Benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl 138–25–0 ...... § 716.21(a)(7) September November ester. 29, 2006 28, 2006 1,3-Benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl 3965–55–7 ..... § 716.21(a)(7) September November ester, sodium salt. 29, 2006 28, 2006 1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester 84–69–5 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, 68988–22–7 ... § 716.21(a)(7) September November by-products from. 29, 2006 28, 2006 Benzenemethanol, .alpha.,.alpha.-dimethyl- ...... 617–94–7 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzenemethanol, 3-phenoxy- ...... 13826–35–2 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzenesulfonic acid, 3-nitro-, sodium salt ...... 127–68–4 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzenesulfonic acid, 4-chloro-3,5-dinitro-, potassium 38185–06–7 ... § 716.21(a)(7) September November salt. 29, 2006 28, 2006 Benzenesulfonic acid, C10–16-alkyl derivs., compds. 68584–25–8 ... § 716.21(a)(7) September November with triethanolamine. 29, 2006 28, 2006 Benzenesulfonic acid, dimethyl- ...... 25321–41–9 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzenesulfonyl chloride ...... 98–09–9 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide ...... 81–07–2 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzoic acid, 2-methyl- ...... 118–90–1 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 2,4,6,8,3,5,7-Benzotetraoxatriplumbacycloundecin-3,5,7- 17976–43–1 ... § 716.21(a)(7) September November triylidene, 1,9-dihydro-1,9-dioxo-. 29, 2006 28, 2006 Benzothiazole, 2-[(chloromethyl)thio]- ...... 28908–00–1 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Benzoyl chloride, 3,5-dichloro- ...... 2905–62–6 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 1,2-Butadiene ...... 590–19–2 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Butanedioic acid, oxo-, diethyl ester, ion(1-), sodium ..... 40876–98–0 ... § 716.21(a)(7) September November 29, 2006 28, 2006 1-Butanol, sodium salt ...... 2372–45–4 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 2-Butenal ...... 4170–30–3 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 2-Butenediamide, (2E)-, N,N’-bis[2-(4,5-dihydro-2- 68442–77–3 ... § 716.21(a)(7) September November nortall-oil alkyl-1H-imidazol-1-yl)ethyl] derivs.. 29, 2006 28, 2006 2-Butenedioic acid (2E)-, di-C8–18-alkyl esters ...... 68610–90–2 ... § 716.21(a)(7) September November 29, 2006 28, 2006 2-Butenedioic acid (2Z)-, dioctyl ester ...... 2915–53–9 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 2-Butenenitrile, 2-methyl-, (2E)- ...... 30574–97–1 ... § 716.21(a)(7) September November 29, 2006 28, 2006

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2-Butenenitrile, 2-methyl-, (2Z)- ...... 20068–02–4 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Carbamic acid, monoammonium salt ...... 1111–78–0 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Carbamodithioic acid, monoammonium salt ...... 513–74–6 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Carbonochloridothioic acid, S-(phenylmethyl) ester ...... 37734–45–5 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Carbonodithioic acid, O-(1-methylethyl) ester, sodium 140–93–2 ...... § 716.21(a)(7) September November salt. 29, 2006 28, 2006 Carboxylic acids, di-, C4–11 ...... 68937–72–4 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Chromate(3-), bis[3-(hydroxy-.kappa.O)-4-[[2-(hydroxy- 57693–14–8 ... § 716.21(a)(7) September November .kappa.O)-1-naphthalenyl]azo-.kappa.N1]-7-nitro-1- 29, 2006 28, 2006 naphthalenesulfonato(3-)]-, trisodium. Coal, anthracite, calcined ...... 68187–59–7 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Creosote ...... 8001–58–9 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Cyclohexane, oxidized, aq. ext., sodium salt ...... 68915–39–9 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Cyclohexane, oxidized, non-acidic by-products, distn. 68609–05–2 ... § 716.21(a)(7) September November lights. 29, 2006 28, 2006 1,3-Cyclopentadiene ...... 542–92–7 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Decane, 1-chloro- ...... 1002–69–3 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Decanoic acid, mixed esters with dipentaerythritol, 68441–66–7 ... § 716.21(a)(7) September November octanoic acid and valeric acid. 29, 2006 28, 2006 1-Decene, sulfurized ...... 72162–15–3 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Distillates (coal tar) ...... 65996–92–1 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Distillates (coal tar), heavy oils ...... 90640–86–1 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Distillates (coal tar), upper ...... 65996–91–0 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Distillates (petroleum), hydrofined lubricating-oil ...... 68782–97–8 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Distillates, hydrocarbon resin prodn. higher boiling ...... 68602–81–3 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Disulfides, alkylaryl dialkyl diaryl, petroleum refinery 68334–01–0 ... § 716.21(a)(7) September November spent caustic oxidn. products. 29, 2006 28, 2006 Disulfides, C5–12-alkyl ...... 68513–62–2 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Ethane, 1,1,1-trimethoxy- ...... 1445–45–0 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Ethane, 1,1’-[methylenebis(oxy)]bis[2-chloro- ...... 111–91–1 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Ethane, 1,1’-oxybis[2-chloro- ...... 111–44–4 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Ethane, 1,2-dichloro-, manuf. of, by-products from, 68608–59–3 ... § 716.21(a)(7) September November distn. lights. 29, 2006 28, 2006 1,2-Ethanediamine, N,N,N’,N’-tetramethyl- ...... 110–18–9 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Ethanedioic acid, calcium salt (1:1) ...... 563–72–4 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 1,2-Ethanediol, dinitrate ...... 628–96–6 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Ethanesulfonic acid, 2-[methyl[(9Z)-1-oxo-9- 137–20–2 ...... § 716.21(a)(7) September November octadecenyl]amino]-, sodium salt. 29, 2006 28, 2006 Ethanimidothioic acid, N-hydroxy-, methyl ester ...... 13749–94–5 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Ethanol, 2-(2-butoxyethoxy)-, sodium salt ...... 38321–18–5 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Ethanol, 2,2’-oxybis-, reaction products with ammonia, 68909–77–3 ... § 716.21(a)(7) September November morpholine derivs. residues. 29, 2006 28, 2006 Ethanol, 2,2’-oxybis-, reaction products with ammonia, 71077–05–9 ... § 716.21(a)(7) September November morpholine product tower residues. 29, 2006 28, 2006 Ethanol, 2-[(4-aminophenyl)sulfonyl]-, hydrogen sulfate 2494–89–5 ..... § 716.21(a)(7) September November (ester). 29, 2006 28, 2006 Ethanol, 2-butoxy-, sodium salt ...... 52663–57–7 ... § 716.21(a)(7) September November 29, 2006 28, 2006

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Ethene, hydrated, by-products from ...... 68987–66–6 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Ethenesulfonic acid, sodium salt ...... 3039–83–6 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Extract oils (coal), tar base ...... 65996–86–3 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Extract residues (coal), tar oil alk...... 65996–87–4 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Extract residues (coal), tar oil alk., naphthalene distn. 73665–18–6 ... § 716.21(a)(7) September November residues. 29, 2006 28, 2006 Extracts, coal tar oil alk...... 65996–83–0 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Fats and Glyceridic oils, vegetable, reclaimed ...... 68990–65–8 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Fatty acids, tall-oil, 2-(2-hydroxyethoxy)ethyl esters ...... 68309–16–0 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Fatty acids, tall-oil, low-boiling, reaction products with 68915–05–9 ... § 716.21(a)(7) September November ammonia-ethanolamine reaction by-products. 29, 2006 28, 2006 Fatty acids, tall-oil, reaction products with 68153–60–6 ... § 716.21(a)(7) September November diethylenetriamine, acetates. 29, 2006 28, 2006 Fatty acids, tall-oil, sulfonated, sodium salts ...... 68309–27–3 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Formic acid, compd. with 2,2’,2[ethanol] (1:1) ...... 24794–58–9 ... § 716.21(a)(7) September November 29, 2006 28, 2006 2,5-Furandione, dihydro-3-(octenyl)- ...... 26680–54–6 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Glycine, N-(carboxymethyl)- ...... 142–73–4 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Glycine, N-(carboxymethyl)-, disodium salt ...... 928–72–3 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Glycine, N-methyl-, monosodium salt ...... 4316–73–8 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Glycine, N-phenyl-, monopotassium salt ...... 19525–59–8 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Glycine, N-phenyl-, monosodium salt ...... 10265–69–7 ... § 716.21(a)(7) September November 29, 2006 28, 2006 1-Hexacosanol ...... 506–52–5 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Hexadecane, 1-chloro- ...... 4860–03–1 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 1,4-Hexadiene ...... 592–45–0 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Hexanedioic acid, dihexyl ester ...... 110–33–8 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Hexanedioic acid, esters with high-boiling C6–10-alkene 84501–86–0 ... § 716.21(a)(7) September November hydroformylation products. 29, 2006 28, 2006 1,3-Hexanediol, 2-ethyl- ...... 94–96–2 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 1,6-Hexanediol, distn. residues ...... 68937–29–1 ... § 716.21(a)(7) September November 29, 2006 28, 2006 2-Hexenal, 2-ethyl- ...... 645–62–5 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 1H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro- ...... 85–40–5 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Hydrocarbons, C12–20, catalytic alkylation by-products 68919–17–5 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Imidodicarbonic diamide, N,N’,2-tris(6-isocyanatohexyl)- 4035–89–6 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 1,3-Isobenzofurandione, 5-methyl- ...... 19438–61–0 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Lard, oil, Me esters ...... 68082–78–0 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Methanesulfonamide, N-[2-[(4-amino-3- 25646–71–3 ... § 716.21(a)(7) September November methylphenyl)ethylamino]ethyl]-, sulfate (2:3). 29, 2006 28, 2006 Methanesulfonic acid, hydroxy-, monosodium salt ...... 870–72–4 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Methanesulfonyl chloride ...... 124–63–0 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Methanone, (2-hydroxy-4-methoxyphenyl)phenyl- ...... 131–57–7 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Naphtha (petroleum), clay-treated light straight-run ...... 68527–22–0 ... § 716.21(a)(7) September November 29, 2006 28, 2006

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Special Exemp- Effective Category CAS No. tions Date Sunset Date

2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, 5460–09–3 ..... § 716.21(a)(7) September November monosodium salt. 29, 2006 28, 2006 1-Naphthalenesulfonic acid, 2-amino- ...... 81–16–3 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 2-Naphthalenesulfonic acid, 6-[(2,4-diaminophenyl)azo]- 6473–13–8 ..... § 716.21(a)(7) September November 3-[[4-[[4-[[7-[(2,4-diaminophenyl)azo]-1-hydroxy-3- 29, 2006 28, 2006 sulfo-2-naphthalenyl]azo]phenyl]amino]-3- sulfophenyl]azo]-4-hydroxy-, trisodium salt. 1-Naphthalenol, 1,2,3,4-tetrahydro- ...... 529–33–9 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 1(2H)-Naphthalenone, 3,4-dihydro- ...... 529–34–0 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 1H,3H-Naphtho[1,8-cd]pyran-1,3-dione ...... 81–84–5 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Nickel, bis[(cyano-C)triphenylborato(1-)- 83864–02–2 ... § 716.21(a)(7) September November N]bis(hexanedinitrile-N,N’)-. 29, 2006 28, 2006 1-Octacosanol ...... 557–61–9 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Octadecane, 1-chloro- ...... 3386–33–2 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Octadecanoic acid, 2-(1-carboxyethoxy)-1-methyl-2- 25383–99–7 ... § 716.21(a)(7) September November oxoethyl ester, sodium salt. 29, 2006 28, 2006 Octadecanoic acid, 2-(hydroxymethyl)-2-[[(1- 28188–24–1 ... § 716.21(a)(7) September November oxooctadecyl)oxy]methyl]-1,3-propanediyl ester. 29, 2006 28, 2006 Octadecanoic acid, reaction products with 2-[(2- 68815–50–9 ... § 716.21(a)(7) September November aminoethyl)amino]ethanol. 29, 2006 28, 2006 9-Octadecenoic acid, 12-(acetyloxy)-, 1,2,3-propanetriyl 101–34–8 ...... § 716.21(a)(7) September November ester, (9Z,9’Z,9’’,12R,12’R,12’’)-. 29, 2006 28, 2006 Octane, 1-chloro- ...... 111–85–3 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 1-Octanesulfonyl chloride ...... 7795–95–1 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 1-Octanesulfonyl fluoride ...... 40630–63–5 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Oxirane, [(2-methylphenoxy)methyl]- ...... 2210–79–9 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Oxiranemethanamine, N-[4-(oxiranylmethoxy)phenyl]-N- 5026–74–4 ..... § 716.21(a)(7) September November (oxiranylmethyl)-. 29, 2006 28, 2006 Paraffin oils, chlorosulfonated, saponified ...... 68188–18–1 ... § 716.21(a)(7) September November 29, 2006 28, 2006 3-Pentanone ...... 96–22–0 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 1-Pentene, 2,4,4-trimethyl- ...... 107–39–1 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 2-Pentene, 2,4,4-trimethyl- ...... 107–40–4 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Phenol, (1,1,3,3-tetramethylbutyl)- ...... 27193–28–8 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Phenol, (1-methylethyl)- ...... 25168–06–3 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Phenol, 2-(1,1-dimethylethyl)-4-methyl- ...... 2409–55–4 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Phenol, 2,4-bis(1,1-dimethylpropyl)-6-[(2- 52184–19–7 ... § 716.21(a)(7) September November nitrophenyl)azo]-. 29, 2006 28, 2006 Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[(2- 70693–50–4 ... § 716.21(a)(7) September November nitrophenyl)azo]-. 29, 2006 28, 2006 Phenol, 3-(diethylamino)- ...... 91–68–9 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Phenol, 4-methyl-2-nitro- ...... 119–33–5 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Phenol, isobutylenated methylstyrenated ...... 68457–74–9 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Phenol, methyl-, sodium salt ...... 34689–46–8 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Phenol, nonyl derivs...... 68081–86–7 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Phenol, styrenated ...... 61788–44–1 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Phenols (petroleum) ...... 64743–03–9 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Phosphoramidothioic acid, O,O-dimethyl ester ...... 17321–47–0 ... § 716.21(a)(7) September November 29, 2006 28, 2006

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Phosphoric acid, (1,1-dimethylethyl)phenyl diphenyl 56803–37–3 ... § 716.21(a)(7) September November ester. 29, 2006 28, 2006 Phosphoric acid, mixed 3-bromo-2,2-dimethylpropyl and 125997–20–8 § 716.21(a)(7) September November 2-bromoethyl and 2-chloroethyl esters. 29, 2006 28, 2006 Phosphorochloridothioic acid, O,O-dimethyl ester ...... 2524–03–0 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Phosphorochloridous acid, bis(4-nonylphenyl) ester ...... 63302–49–8 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Phosphorodichloridic acid, ethyl ester ...... 1498–51–7 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Phosphorodithioic acid, O,O-di-C1–14-alkyl esters ...... 68187–41–7 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Phosphorodithioic acid, O,O-di-C1–14-alkyl esters, zinc 68649–42–3 ... § 716.21(a)(7) September November salts. 29, 2006 28, 2006 Phosphorodithioic acid, O,O-dimethyl ester ...... 756–80–9 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Phosphorodithioic acid, O,O-dimethyl ester, sodium salt 26377–29–7 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Phosphorous acid, 2-(1,1-dimethylethyl)-4-[1-[3-(1,1- 20227–53–6 ... § 716.21(a)(7) September November dimethylethyl)-4-hydroxyphenyl]-1-methylethyl]phenyl 29, 2006 28, 2006 bis(4-nonylphenyl) ester. Phosphorous acid, isooctyl diphenyl ester ...... 26401–27–4 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Piperazineethanol ...... 25154–38–5 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Pitch, coal tar-petroleum ...... 68187–57–5 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Propane, 2,2-dimethoxy- ...... 77–76–9 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Propanenitrile, 3-(dimethylamino)- ...... 1738–25–6 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 1-Propanesulfonic acid, 2-hydroxy-3-(2-propenyloxy)-, 52556–42–0 ... § 716.21(a)(7) September November monosodium salt. 29, 2006 28, 2006 Propanoic acid, 2-bromo- ...... 598–72–1 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4- 22527–63–5 ... § 716.21(a)(7) September November trimethylpentyl ester. 29, 2006 28, 2006 2-Propenoic acid, 2-carboxyethyl ester ...... 24615–84–7 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Pyridine, hydrochloride ...... 628–13–7 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 4(1H)-Pyrimidinone, 6-methyl-2-(1-methylethyl)- ...... 2814–20–2 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Solvent naphtha (coal) ...... 65996–79–4 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Sulfonic acids, petroleum ...... 61789–85–3 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Tannins ...... 1401–55–4 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Tannins, reaction products with sodium bisulfite, sodium 72854–27–4 ... § 716.21(a)(7) September November polysulfide and sodium sulfite. 29, 2006 28, 2006 Tar oils, coal ...... 65996–82–9 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Tar, coal, dried and oxidized ...... 68918–16–1 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Tar, coal, high-temp...... 65996–89–6 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Tar, coal, high-temp., high-solids ...... 68990–61–4 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Terpenes and Terpenoids, C10–30, distn. residues ...... 70084–98–9 ... § 716.21(a)(7) September November 29, 2006 28, 2006 1-Tetracosanol ...... 506–51–4 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Tetradecane, 1-chloro- ...... 2425–54–9 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 1,3,5,7-Tetrazocine, octahydro-1,3,5,7-tetranitro- ...... 2691–41–0 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Thiazole, 4-methyl- ...... 693–95–8 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Thiourea ...... 62–56–6 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 1,3,5-Triazine, hexahydro-1,3,5-trinitro- ...... 121–82–4 ...... § 716.21(a)(7) September November 29, 2006 28, 2006

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Special Exemp- Effective Category CAS No. tions Date Sunset Date

1,3,5-Triazine-2,4,6(1H,3H,5H)-trione, 1,3,5-tris(6- 3779–63–3 ..... § 716.21(a)(7) September November isocyanatohexyl)-. 29, 2006 28, 2006 1,3,5-Triazine-2,4-diamine, 6-chloro-N-(1,1- 5915–41–3 ..... § 716.21(a)(7) September November dimethylethyl)-N’-ethyl-. 29, 2006 28, 2006 1,3,5-Triazine-2,4-diamine, 6-chloro-N,N’-bis(1- 139–40–2 ...... § 716.21(a)(7) September November methylethyl)-. 29, 2006 28, 2006 1,3,5-Triazine-2,4-diamine, 6-chloro-N-ethyl-N’-(1- 1912–24–9 ..... § 716.21(a)(7) September November methylethyl)-. 29, 2006 28, 2006 Urea, (hydroxymethyl)- ...... 1000–82–4 ..... § 716.21(a)(7) September November 29, 2006 28, 2006 Urea, N’-(3,4-dichlorophenyl)-N,N-dimethyl- ...... 330–54–1 ...... § 716.21(a)(7) September November 29, 2006 28, 2006 Urea, sulfate (1:1) ...... 21351–39–3 ... § 716.21(a)(7) September November 29, 2006 28, 2006 Urea, sulfate (2:1) ...... 17103–31–0 ... § 716.21(a)(7) September November 29, 2006 28, 2006

[53 FR 38645, Sept. 30, 1988]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 716.120, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

EFFECTIVE DATE NOTE: At 59 FR 14115, Mar. 25, 1994, in § 716.120 paragraph (d), the chemical substances under the category ‘‘propylene glycol ethers and esters’’ and all related dates, were stayed effective March 25, 1994.

PART 717—RECORDS AND REPORTS ronment, as determined by the Admin- OF ALLEGATIONS THAT CHEM- istrator by rule, alleged to have been caused by the substance or mixture.’’ ICAL SUBSTANCES CAUSE SIG- (b) To ‘‘permit inspection and submit NIFICANT ADVERSE REACTIONS copies of such records’’, upon request of TO HEALTH OR THE ENVIRON- any designated representative of the MENT Administrator. This rule implements section 8(c) of TSCA. It describes the Subpart A—General Provisions records to be kept and prescribes the Sec. conditions under which certain firms 717.1 Scope and compliance. must submit or make the records avail- 717.3 Definitions. able to a duly designated representa- 717.5 Persons subject to this part. tive of the Administrator. 717.7 Persons not subject to this part. 717.10 Allegations subject to this part. § 717.3 Definitions. 717.12 Significant adverse reactions that The definitions set forth in section 3 must be recorded. 717.15 Recordkeeping requirements. of TSCA and the following definitions 717.17 Inspection and reporting require- apply to this part: ments. (a) Allegation means a statement, 717.19 Confidentiality. made without formal proof or regard for evidence, that a chemical substance AUTHORITY: 15 U.S.C. 2607(c). or mixture has caused a significant ad- SOURCE: 48 FR 38187, Aug. 22, 1983, unless verse reaction to health or the environ- otherwise noted. ment. (b) Firm or company means any per- Subpart A—General Provisions son, that is subject to this part, as defined in § 717.5. § 717.1 Scope and compliance. (c)(1) Known human effects means a Section 8 (c) of the Toxic Substances commonly recognized human health ef- Control Act (TSCA) requires manufac- fect of a particular substance or mix- turers, processors, and distributors of ture as described either in: chemical substances and mixtures: (i) Scientific articles or publications (a) To keep ‘‘records of significant abstracted in standard reference adverse reactions to health or the envi- sources.

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(ii) The firm’s product labeling or diate or eventual commercial advan- material safety data sheets (MSDS). tage for the processor. Processing of (2) However, an effect is not a any amount of a chemical substance or ‘‘known human effect’’ if it: mixture is included. If a chemical sub- (i) Was a significantly more severe stance or mixture containing impuri- toxic effect than previously described. ties is processed for commercial pur- (ii) Was a manifestation of a toxic ef- poses, then those impurities are also fect after a significantly shorter expo- processed for commercial purposes. sure period or lower exposure level (h) Retailer means a person who dis- than described. tributes in commerce a chemical sub- (iii) Was a manifestation of a toxic stance, mixture, or article to ultimate effect by an exposure route different purchasers who are not commercial en- from that described. tities. (d) Manufacture or process means to (i) Significant adverse reactions are re- manufacture or process for commercial actions that may indicate a substantial purposes. impairment of normal activities, or (e)(1) Manufacture for commercial pur- long-lasting or irreversible damage to poses means to import, produce, or health or the environment. manufacture with the purpose of ob- (j) Site means a contiguous property taining an immediate or eventual com- unit. Property divided only by a public mercial advantage for the manufac- right-of-way is considered one site. turer, and includes, among other There may be multiple manufacturing, things, such ‘‘manufacture’’ of any processing, or distribution activities amount of a chemical substance or occurring within a single site. mixture: (k) Substance means a chemical sub- (i) For distribution in commerce, instance or mixture unless otherwise including for test marketing. dicated. (ii) For use by the manufacturer, including use for product research and § 717.5 Persons subject to this part. development, or as an intermediate. (a) Manufacturers. (1) All manufactur- (2) Manufacture for commercial pur- ers of chemical substances are subject poses also applies to substances that to this part except as provided in are produced coincidentally during the § 717.7(a). If manufacture of a chemcial manufacture, processing, use, or dis- substance occurs at any site owned or posal of another substance or mixture, controlled by a firm then that firm is including both byproducts that are sep- subject to this part. arated from that other substances or (2) A manufacturer must collect: mixture and impurities that remain in (i) Any allegation identifying a that substance or mixture. Such by- chemical substance it manufactures products and impurities may, or may and any allegation identifying the op- not, in themselves have commercial erations in the manufacture of any value. They are nonetheless produced chemical substance it manufactures. for the purpose of obtaining a commer- (ii) Any allegation identifying any of cial advantage since they are part of its own processing or distribution in the manufacture of a chemical product commerce activities with respect to for a commercial purpose. any chemical substance it manufac- (f) Person includes any individual, tures. firm, company, corporation, joint ven- (iii) Any allegation identifying emis- ture, partnership, sole proprietorship, sions, effluents, or other discharges association, or any other business enti- from activities described in this para- ty, any State or political subdivision graph. thereof, and any department, agency, (iv) Any allegation identifying a sub- or instrumentally of the Federal Gov- stance produced coincidentally during ernment. processing, use, storage or disposal of a (g) Process for commercial purposes chemical substance it manufactures. means the preparation of a chemical (3) For the purpose of this part, substance or mixture, after its manu- owned or controlled means ownership facture, for distribution in commerce of 50 percent or more of a firm’s voting with the purpose of obtaining an imme- stock or other equity rights, or the

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power to control the management and lic minerals (including extraction of policies of that firm. salts from seawater or brines), mine or (b) Processors. (1) A person who proc- otherwise extract coal, or separate esses chemical substances, who is not gases from the atmosphere. This ex- also a manufacturer of those chemical emption may include, but is not nec- substances, is subject to this part if (i) essarily limited to, firms engaged in the person processes chemical sub- activities as described in SIC Division stances to produce mixtures, or (ii) the B—Mining and SIC Code 2813—Indus- person repackages chemical substances trial Gases. or mixtures. (2) A person is not subject to this (2) As a processor subject to this part part if the chemical substances that such person must collect: person causes to be produced are lim- (i) Any allegation identifying any ited to: mixture it produces and distributes in (i) Chemical substances that result commerce and any allegation identi- from chemical reactions that occur in- fying any chemical substance or mix- cidental to exposure of another chem- ture it repackages and distributes in ical substance, mixture, or article to commerce. environmental factors such as air, (ii) Any allegation identifying any of moisture, microbial organisms, or sun- its own further processing or distribu- light. tion in commerce activities of the (ii) Chemical substances that result products described in paragraph from chemical reactions that occur in- (b)(2)(i) of this section. cidental to storage or disposal of other (iii) Any allegation identifying emis- chemical substances, mixtures, or arti- sions, effluents, or other discharges cles. from activities described in this para- (iii) Chemical substances that result graph. from chemical reactions that occur (iv) Any allegation identifying a sub- upon end use of other chemical substance produced coincidentally during stances, mixtures, or articles such as the processing, use, storage or disposal adhesives, paints, miscellaneous clean- of the products described in paragraph ers or other housekeeping products, (b)(2)(i) of this section. fuel additives, water softening and (c) SIC code. SIC codes applicable to treatment agents, photographic films, this part are published in Standard In- batteries, matches, or safety flares, dustrial Classification Manual—1972 and that are not themselves manufac- and the 1977 Supplement. This manual tured or imported for distribution in and supplement may be obtained from commerce for use as chemical inter- the U.S. Government Printing Office, mediates. Washington, D.C. 20402—stock number (iv) Chemical substances that result 4101–0006 and stock number 003–005– from chemical reactions that occur 0170–0 respectively. Where there is a upon use of curable plastic or rubber conflict between the SIC code use of a molding compounds, inks, drying oils, term and the definition of that term in metal finishing compounds, adhesives, this part, the definition in this part ap- or paints, or other chemical substance plies. formed during the manufacture of an [48 FR 38187, Aug 22, 1983, as amended at 50 article destined for the marketplace FR 46769, Nov. 13, 1985] without further chemical change of the chemical substance. § 717.7 Persons not subject to this (v) Chemical substances that result part. from chemical reactions that occur (a) Manufacturers. (1) Persons or site when (A) a stabilizer, colorant, odor- activities are exempt from this part if ant, antioxidant, filler, solvent, car- the means by which they manufacture rier, surfactant, plasticizer, corrosion a chemical substance solely involves inhibitor, antifoamer or defoamer, dis- mining or other solely extractive func- persant, precipitation-inhibitor, bind- tions, e.g., those companies or sites er, emulsifier, deemulsifier, dewatering within a company whose sole function agent, agglomerating agent, adhesion is to mine mineral ores, extract petro- promoter, flow modifier, pH adjuster, leum or natural gas, quarry non-metal- sequestrant, coagulant, flocculant, fire

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retardant, lubricant, chelating agent, (iv) Naming a company process or op- or quality control reagent functions as eration in which substances are in- intended, or (B) a chemical substance, volved. which is intended solely to impart a (v) Identifying an effluent, emission, specific physicochemical char- or other discharge from a site of manu- acteristic, functions as intended. facturing, processing or distribution of (b) [Reserved] a substance. (c) Sole distributors. A person solely (c) Allegations subject to this part engaged in the distribution of chemical may be made to a firm by any person, substances is exempt from this part, such as an employee of the firm, indi- unless such person is also a manufac- vidual consumer, a neighbor of the turer or processor subject to this part. firm’s plant, another firm on behalf of For example, a ‘‘distributor’’ who re- its employees or an organization on be- packages chemical substances or mix- half of its members. tures is considered to be a processor (d) EPA intends that firms should, to and, thus, is not a sole distributor. the maximum practical extent, provide Sole distributors may include, but are allegers with information regarding not limited to, those firms that dis- the ultimate disposition of their alle- tribute chemical substances as de- gations. For example, firms could pro- scribed in the wholesale trade SIC vide a brief notice to the alleger stat- codes 5161—Chemicals and Allied Prod- ing that a record was created under ucts, 5171—Petroleum Bulk Stations this part based upon their allegation, and Terminals, and 5172—Petroleum or that a record was not created and and Petroleum Products Wholesalers, briefly explain the reasons why not. Except Bulk Stations and Terminals. (d) Retailers. A person who is a re- § 717.12 Significant adverse reactions tailer is exempt from this part unless that must be recorded. such person is also a manufacturer or a (a) Except as provided in paragraph processor subject to this part. (b) of this section, significant adverse [48 FR 38187, Aug 22, 1983, as amended at 50 reactions to human health that must FR 46770, Nov. 13, 1985] be recorded include but are not limited to: § 717.10 Allegations subject to this (1) Long-lasting or irreversible dam- part. age, such as cancer or birth defects. (a) Allegations subject to this part (2) Partial or complete impairment of are those allegations received on or bodily functions, such as reproductive after November 21, 1983 by persons sub- disorders, neurological disorders or ject to this part. blood disorders. (b) Allegations subject to this part (3) An impairment of normal activi- are those that: ties experienced by all or most of the (1) Are submitted either in writing persons exposed at one time. and are signed by the alleger, or are (4) An impairment of normal activi- submitted orally. In the case of an oral ties which is experienced each time an allegation, the firm must transcribe individual is exposed. the allegation into written form, or it (b) Firms are not required to record must inform the alleger that such alle- significant adverse reactions that are gation may be subject to this part and known human effects as defined in request that the alleger submit such § 717.3(c). allegation to the firm in writing and (c) Except as provided in paragraph signed. (d) of this section, significant adverse (2) Implicate a substance that caused reactions to the environment that the stated significant adverse reaction must be recorded, even if restricted to by one of the following: the environs of a plant or disposal site, (i) Naming the specific substance. include but are not limited to: (ii) Naming a mixture that contains a (1) Gradual or sudden changes in the specific substance. composition of animal life or plant life, (iii) Naming an article that contains including fungal or microbial orga- a specific substance. nisms, in an area.

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(2) Abnormal number of deaths of or- and year of birth of the individual ganisms (e.g., fish kills). should be recorded, if ascertainable. (3) Reduction of the reproductive suc- (v) A description of the alleged cess or the vigor of a species. health effect(s). The description must (4) Reduction in agricultural produc- relate how the effect(s) became known tivity, whether crops or livestock. and the route of exposure, if explained (5) Alterations in the behavior or dis- in the allegation. tribution of a species. (vi) A description of the nature of the (6) Long lasting or irreversible con- alleged environmental effect(s), identi- tamination of components of the phys- fying the affected plant and/or animal ical environment, especially in the species, or contaminated portion of the case of ground water, and surface water physical environment. and soil resources that have limited (3) The results of any self-initiated self-cleansing capability. investigation with respect to an allega- (d) Firms are not required to record a tion. (EPA does not require persons significant adverse reaction to the en- subject to this part to investigate alle- vironment if the alleged cause of that gations received, and no provision of significant adverse reaction can be di- this part shall be construed to imply rectly attributable to an accidental that EPA recommends, encourages or spill or other accidental discharge, requires such investigation.) emission exceeding permitted limits, (4) Copies of any further required or other incident of environmental con- records or reports relating to the alle- tamination that has been reported to gation. For example, if an employee al- the Federal Government under any ap- legation results in a requirement for plicable authority. the firm to record the case on Occupa- [48 FR 38187, Aug. 22, 1983, as amended at 49 tional Safety and Health Form 101 or FR 23183, June 5, 1984; 58 FR 34204, June 23, appropriate substitute (see 29 CFR part 1993] 1904 for requirements under the Occu- pational Safety and Health Act of 1970), § 717.15 Recordkeeping requirements. a copy of that OSHA record must be in- (a) Establishment and location of cluded in the allegation record. records. A firm subject to this part (c) File structure. Records must be re- shall establish and maintain records of trievable by the alleged cause of the significant adverse reactions alleged to significant adverse reaction, which have been caused by chemical sub- cause may be one of the following: stances or mixtures manufactured or (1) A specific chemical identity. processed by the firm. Such records (2) A mixture. shall be kept at the firm’s head- (3) An article. quarters or at any other appropriate (4) A company process or operation. location central to the firm’s chemical (5) A site emission, effluent or other operations. discharge. (b) Content of records. The record (d) Retention period. Records of sig- shall consist of the following: nificant adverse reactions to the health (1) The original allegation as re- of employees shall be retained for a pe- ceived. riod of 30 years from the date such re- (2) An abstract of the allegation and actions were first reported to or known other pertinent information as follows: by the person maintaining such (i) The name and address of the plant records. This provision requires per- site which received the allegation. sons subject to this part to retain for 30 (ii) The date the allegation was re- years an employee health related alle- ceived at that site. gation, arising from any employment (iii) The implicated substance, mix- related exposure, whether or not such ture, article, company process or oper- allegation was submitted by or on the ation, or site discharge. behalf of that recordkeeper’s own em- (iv) A description of the alleger (e.g., ployee. Any other record of significant ‘‘company employee,’’ ‘‘individual con- adverse reactions shall be maintained sumer,’’ ‘‘plant neighbor’’). If the alle- for a period of five years from the date gation involves a health effect, the sex the information contained in the

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record was first reported to or known tiality claim covering all or part of the by the person maintaining the record. submitted information. Any informa- (e) Transfer of records. (1) If a firm tion covered by a claim will be dis- ceases to do business, the successor closed by EPA only as provided in pro- must receive and keep all the records cedures set forth at part 2 of this title. that must be kept under this part. (b) If no claim accompanies a docu- (2) If a firm ceases to do business and ment at the time it is submitted to there is no successor to receive and EPA, the document will be placed in an keep the records for the prescribed pe- open file available to the public with- riod, these records must be transmitted out further notice to the respondent. to EPA. See § 717.17(c) for the address to which such records must be sent. (c) To asset a claim of confidentiality for information contained in a sub- [48 FR 38187, Aug. 22, 1983, as amended at 49 mitted record, the respondent must FR 23183, June 5, 1984; 58 FR 34204, June 23, submit two copies of the document. 1993] (1) One copy must be complete. In § 717.17 Inspection and reporting re- that copy, the respondent must indi- quirements. cate what information, if any, is (a) Inspection. Firms must make claimed as confidential by marking the records of allegations available for in- specific information on each page with spection by any duly designated rep- a label such as ‘‘confidential’’, ‘‘pro- resentative of the Administrator. prietary’’, or ‘‘trade secret’’ and briefly (b) Reporting. Each person who is re- state the basis of the claim. quired to keep records under this part (2) If some information is claimed as must submit copies of those records to confidential, the respondent must sub- the Agency as required by the EPA Ad- mit a second copy of the record. The ministrator or appropriate designee. second copy must be complete, except EPA will notify those responsible for that all information claimed as con- reporting by letter or will announce fidential in the first copy must be de- any such requirements for submitting leted. copies of records by a notice in the (3) The first copy will be for internal FEDERAL REGISTER. Such letter or no- use by EPA. The second copy will be tice will be signed by the Adminis- placed in an open file to be available to trator or appropriate designee, and will the public. specify which records or portion of (4) Failure to furnish a second copy records must be submitted. The report- when information is claimed as con- ing period will be specified by the let- fidential in the first copy will be con- ter or notice but in no case will such reporting period be less than 45 days sidered a presumptive waiver of the from the date of the letter or the effec- claim of confidentiality. EPA will no- tive date of the notice. tify the respondent by certified mail (c) How to report. When required to that a finding of a presumptive waiver report, firms must submit copies of of the claim of confidentiality has been records (preferably by certified mail) made. The respondent will be given 30 to the Document Control Office (DCO) days from the date of receipt of notifi- (7407M), Office of Pollution Prevention cation to submit the required second and Toxics (OPPT), Environmental copy. If the respondent fails to submit Protection Agency, 1200 Pennsylvania the second copy within the 30 days, Ave., NW., Washington, DC 20460–0001, EPA will place the first copy in the ATTN: 8(c) Allegations. public file. [48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 52 FR 20084, May 29, PART 720—PREMANUFACTURE 1987; 53 FR 12523, Apr. 15, 1988; 58 FR 34204, NOTIFICATION June 23, 1993; 60 FR 34464, July 3, 1995; 71 FR 33641, June 12, 2006] Subpart A—General Provisions

§ 717.19 Confidentiality. Sec. (a) Any person submitting copies of 720.1 Scope. records may assert a business confiden- 720.3 Definitions.

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Subpart B—Applicability This part applies to microorganisms only to the extent provided by part 725 720.22 Persons who must report. of this chapter. The rule defines the 720.25 Determining whether a chemical substance is on the Inventory. persons and chemical substances sub- 720.30 Chemicals not subject to notification ject to the reporting requirements, pre- requirements. scribes the contents of section 5 no- 720.36 Exemption for research and develop- tices, and establishes procedures for ment. submitting notices. The rule also es- 720.38 Exemptions for test marketing. tablishes EPA policy regarding claims of confidentiality for, and public dis- Subpart C—Notice Form closure of, various categories of infor- 720.40 General. mation submitted in connection with 720.45 Information that must be included in section 5 notices. the notice form. 720.50 Submission of test data and other [48 FR 21742, May 13, 1983, as amended at 58 data concerning the health and environ- FR 34204, June 23, 1993; 62 FR 17932, April 11, mental effects of a substance. 1997] 720.57 Imports. § 720.3 Definitions. Subpart D—Disposition of Notices (a)(1) For the purposes of this part, 720.60 General. the terms cosmetic, device, drug, food, 720.62 Notice that notification is not re- and food additive have the meanings quired. contained in the Federal Food, Drug, 720.65 Acknowledgement of receipt of a no- and Cosmetic Act, 21 U.S.C. 321 et seq., tice; errors in the notice; incomplete sub- and the regulations issued under it. In missions; and false and misleading state- addition, the term ‘‘food’’ includes ments. poultry and poultry products, as de- 720.70 Notice in the FEDERAL REGISTER. 720.75 Notice review period. fined in the Poultry Products Inspec- 720.78 Recordkeeping. tion Act, 21 U.S.C. 453 et seq.; meats and meat food products, as defined in the Subpart E—Confidentiality and Public Federal Meat Inspection Act, 21 U.S.C. Access to Information 60 et seq.; and eggs and egg products, as defined in the Egg Products Inspection 720.80 General provisions. 720.85 Chemical identity. Act, 21 U.S.C. 1033 et seq. 720.87 Categories or proposed categories of (2) The term pesticide has the mean- uses of a new chemical substance. ing contained in the Federal Insecti- 720.90 Data from health and safety studies. cide, Fungicide, and Rodenticide Act, 7 720.95 Public file. U.S.C. 136 et seq. and the regulations issued under it. Subpart F—Commencement of (3) The terms byproduct material, Manufacture or Import source material, and special nuclear mate- 720.102 Notice of commencement of manu- rial have the meanings contained in the facture or import. Atomic Energy Act of 1954, 42 U.S.C 2014 et seq. and the regulations issued Subpart G—Compliance and Inspections under it. 720.120 Compliance. (b) Act means the Toxic Substances 720.122 Inspections. Control Act, 15 U.S.C. 2601 et seq. (c) Article means a manufactured AUTHORITY: 15 U.S.C. 2604, 2607, and 2613. item (1) which is formed to a specific SOURCE: 48 FR 21742, May 13, 1983, unless shape or design during manufacture, (2) otherwise noted. which has end use function(s) dependent in whole or in part upon its shape Subpart A—General Provisions or design during end use, and (3) which has either no change of chemical com- § 720.1 Scope. position during its end use or only This part establishes procedures for those changes of composition which the reporting of new chemical sub- have no commercial purpose separate stances by manufacturers and import- from that of the article and that may ers under section 5 of the Toxic Sub- occur as described in § 720.36(g)(5), ex- stances Control Act, 15 U.S.C. 2604. cept that fluids and particles are not

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considered articles regardless of shape ical, and ecological, or other studies of or design. a chemical substance or mixture, and (d) Byproduct means a chemical sub- any test performed under the Act. stance produced without a separate Chemical identity is always part of a commercial intent during the manufac- health and safety study. ture, processing, use, or disposal of an- (1) Not only is information which other chemical substance or mixture. arises as a result of a formal, dis- (e) Chemical substance means any or- ciplined study included, but other in- ganic or inorganic substance of a par- formation relating to the effects of a ticular molecular identity, including chemical substance or mixture on any combination of such substances oc- health or the environment is also in- curring in whole or in part as a result cluded. Any data that bear on the ef- of a chemical reaction or occurring in fects of a chemical substance on health nature, and any chemical element or or the environment would be included. uncombined radical, except that ‘‘chemical substance’’ does not include: (2) Examples include: (1) Any mixture. (i) Long- and short-term tests of mu- (2) Any pesticide when manufactured, tagenicity, carcinogenicity, or processed, or distributed in commerce teratogenicity; data on behavioral dis- for use as a pesticide. orders; dermatoxicity; pharmacological (3) Tobacco or any tobacco product. effects; mammalian absorption, dis- (4) Any source material, special nu- tribution, metabolism, and excretion; clear material, or byproduct material. cumulative, additive, and synergistic (5) Any pistol, firearm, revolver, effects; acute, subchronic, and chronic shells, or cartridges. effects; and structure/activity anal- (6) Any food, food additive, drug, cos- yses. metic, or device, when manufactured, (ii) Tests for ecological or other envi- processed, or distributed in commerce ronmental effects on invertebrates, for use as a food, food additive, drug, fish, or other animals, and plants, in- cosmetic, or device. cluding: Acute toxicity tests, chronic (f) Commerce means trade, traffic, toxicity tests, critical life stage tests, transportation, or other commerce (1) behavioral tests, algal growth tests, between a place in a State and any seed germination tests, plant growth or place outside of such State, or (2) damage tests, microbial function tests, which affects trade, traffic, transpor- bioconcentration or bioaccumulation tation, or commerce between a place in tests, and model ecosystem (micro- a State and any place outside of such cosm) studies. State. (iii) Assessments of human and envi- (g) Customs territory of the United ronmental exposure, including work- States means the 50 States, Puerto place exposure, and impacts of a par- Rico, and the District of Columbia. ticular chemical substance or mixture (h) Director means the Director of the on the environment, including surveys, EPA Office of Pollution Prevention and tests, and studies of: Biological, photo- Toxics. chemical, and chemical degradation; (i) Distribute in commerce means to sell in commerce, to introduce or de- air, water, and soil transport; bio- liver for introduction into commerce, magnification and bioconcentration; or to hold after introduction into com- and chemical and physical properties, merce. e.g., boiling point, vapor pressure, (j) EPA means the U.S. Environ- evaporation rates from soil and water, mental Protection Agency. octanol/water partition coefficient, and (k) Health and safety study or study water solubility. means any study of any effect of a (iv) Monitoring data, when they have chemical substance or mixture on been aggregated and analyzed to meas- health or the environment or on both, ure the exposure of humans or the en- including underlying data and epide- vironment to a chemical substance or miological studies, studies of occupa- mixture. tional exposure to a chemical sub- (v) Any assessments of risk to health stance or mixture, toxicological, clin- and the environment resulting from

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the manufacture, processing, distribu- things, ‘‘manufacture’’ of any amount tion in commerce, use, or disposal of of a chemical substance or mixture: the chemical substance. (i) For commercial distribution, in- (l) Importer means any person who cluding for test marketing. imports a chemical substance, includ- (ii) For use by the manufacturer, in- ing a chemical substance as part of a cluding use for product research and mixture or article, into the customs development or as an intermediate. territory of the United States. ‘‘Im- (2) The term also applies to sub- porter’’ includes the person primarily stances that are produced coinciden- liable for the payment of any duties on tally during the manufacture, proc- the merchandise or an authorized essing, use, or disposal of another sub- agent acting on his or her behalf. The stance or mixture, including byprod- term also includes, as appropriate: ucts that are separated from that other (1) The consignee. substance or mixture and impurities (2) The importer of record. that remain in that substance or mix- (3) The actual owner if an actual ture. Byproducts and impurities with- owner’s declaration and superseding out separate commercial value are bond has been filed in accordance with nonetheless produced for the purpose of 19 CFR 141.20; or obtaining a commercial advantage, since they are part of the manufacture (4) The transferee, if the right to of a chemical substance for commercial draw merchandise in a bonded ware- purposes. house has been transferred in accord- (s) ance with subpart C of 19 CFR part 144. Manufacture solely for export means to manufacture or import for (See ‘‘principal importer.’’) commercial purposes a chemical sub- (m) Impurity means a chemical substance solely for export from the stance which is unintentionally United States under the following represent with another chemical sub- strictions on activities in the United stance. States: (n) Intermediate means any chemical (1) Distribution in commerce is lim- substance that is consumed, in whole ited to purposes of export or processing or in part, in chemical reactions used solely for export as defined in § 721.3 of for the intentional manufacture of an- this chapter. other chemical substance(s) or mix- (2) The manufacturer or importer, ture(s), or that is intentionally present and any person to whom the substance for the purpose of altering the rates of is distributed for purposes of export or such chemical reactions. processing solely for export (as defined (o) Inventory means the list of chem- in § 721.3 of this chapter), may not use ical substances manufactured or proc- the substance except in small quan- essed in the United States that EPA tities solely for research and develop- compiled and keeps current under sec- ment in accordance with § 720.36. tion 8(b) of the Act. (t) Manufacturer means a person who (p) Known to or reasonably ascertain- imports, produces, or manufactures a able by means all information in a per- chemical substance. A person who ex- son’s possession or control, plus all in- tracts a component chemical substance formation that a reasonable person from a previously existing chemical similarly situated might be expected to substance or a complex combination of possess, control, or know. substances is a manufacturer of that (q) Manufacture means to produce or component chemical substance. A per- manufacture in the United States or son who contracts with a manufacturer import into the customs territory of to manufacture or produce a chemical the United States. substance is also a manufacturer if (1) (r) Manufacture or import for commer- the manufacturer manufactures or pro- cial purposes means: duces the substance exclusively for (1) To import, produce, or manufac- that person, and (2) that person speci- ture with the purpose of obtaining an fies the identity of the substance and immediate or eventual commercial ad- controls the total amount produced vantage for the manufacturer or im- and the basic technology for the plant porter, and includes, among other process.

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(u) Mixture means any combination of owns or controls 50 percent or more of two or more chemical substances if the the other company’s voting stock. A combination does not occur in nature parent company owns or controls any and is not, in whole or in part, the re- partnership in which it is a general sult of a chemical reaction; except partner). Information is included with- ‘‘mixture’’ does include (1) any com- in this definition if it is: bination which occurs, in whole or in (1) In files maintained by submitter’s part, as a result of a chemical reaction employees who are: if the combination could have been (i) Associated with research, develop- manufactured for commercial purposes ment, test marketing, or commercial without a chemical reaction at the marketing of the chemical substance time the chemical substances com- in question. prising the combination were com- (ii) Reasonably likely to have such bined, and if all of the chemical sub- data. stances comprising the combination (2) Maintained in the files of other are not new chemical substances, and agents of the submitter who are associ- (2) hydrates of a chemical substance or ated with research, development, test hydrated ions formed by association of marketing, or commercial marketing a chemical substance with water, so of the chemical substance in question long as the nonhydrated form is itself in the course of their employment as not a new chemical substance. such agents. (v) New chemical substance means any chemical substance which is not in- (z) Principal importer means the first cluded on the Inventory. importer who, knowing that a new (w) Nonisolated intermediate means chemical substance will be imported any intermediate that is not inten- rather than manufactured domesti- tionally removed from the equipment cally, specifies the identity of the in which it is manufactured, including chemical substance and the total the reaction vessel in which it is manu- amount to be imported. Only persons factured, equipment which is ancillary who are incorporated, licensed, or to the reaction vessel, and any equip- doing business in the United States ment through which the chemical sub- may be principal importers. stance passes during a continuous flow (aa) Process means the preparation of process, but not including tanks or a chemical substance or mixture, after other vessels in which the substance is its manufacture, for distribution in stored after its manufacture. commerce (1) in the same form or phys- (x) Person means any natural person, ical state as, or in a different form or firm, company, corporation, joint-ven- physical state from, that in which it ture, partnership, sole proprietorship, was received by the person so preparing association, or any other business enti- such substance or mixture, or (2) as ty, any State or political subdivision part of a mixture or article containing thereof, any municipality, any inter- the chemical substance or mixture. state body, and any department, agen- (bb) Processor means any person who cy or instrumentality of the Federal processes a chemical substance or mix- Government. ture. (y) Possession or control means in pos- (cc) Small quantities solely for research session or control of the submitter, or and development (or ‘‘small quantities of any subsidiary, partnership in which solely for purposes of scientific experi- the submitter is a general partner, par- mentation or analysis or chemical re- ent company, or any company or part- search on, or analysis of, such sub- nership which the parent company stance or another substance, including owns or controls, if the subsidiary, par- such research or analysis for the devel- ent company, or other company or opment of a product’’) means quan- partnership is associated with the sub- tities of a chemical substance manu- mitter in the research, development, factured, imported, or processed or pro- test marketing, or commercial mar- posed to be manufactured, imported, or keting of the chemical substance in processed solely for research and devel- question. (A parent company owns or opment that are not greater than rea- controls another company if the parent sonably necessary for such purposes.

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(dd) State means any State of the other TSCA section 5 notices and sup- United States and the District of Co- port documents electronically to the lumbia, the Commonwealth of Puerto Agency. Rico, the Virgin Islands, Guam, the (kk) Optical disc means compact disc Canal Zone, American Samoa, the (CD) or digital video disc (DVD). Northern Mariana Islands, and any (ll) Support documents means mate- other territory or possession of the rials and information submitted to United States. EPA in support of a TSCA section 5 no- (ee) Technically qualified individual tice, including but not limited to, cor- means a person or persons (1) who, be- respondence, amendments, and test cause of education, training, or experi- data. The term ‘‘support documents’’ ence, or a combination of these factors, does not include orders under TSCA is capable of understanding the health section 5(e) (either consent orders or and environmental risks associated orders imposed pursuant to TSCA sec- with the chemical substance which is tion 5(e)(2)(B)). used under his or her supervision, (2) [48 FR 21742, May 13, 1983, as amended at 51 who is responsible for enforcing appro- FR 15101, Apr. 22, 1986; 75 FR 784, Jan. 6, 2010] priate methods of conducting scientific experimentation, analysis, or chemical Subpart B—Applicability research to minimize such risks, and (3) who is responsible for the safety as- § 720.22 Persons who must report. sessments and clearances related to the (a)(1) Any person who intends to procurement, storage, use, and disposal manufacture a new chemical substance of the chemical substance as may be in the United States for commercial appropriate or required within the purposes must submit a notice unless scope of conducting a research and de- the substance is excluded under § 720.30. velopment activity. (2) If a person contracts with a manu- (ff) Test data means data from a for- facturer to manufacture or produce a mal or informal test or experiment, in- new chemical substance, and (i) the cluding information concerning the ob- manufacturer manufactures or pro- jectives, experimental methods and duces the substance exclusively for materials, protocols, results, data anal- that person, and (ii) that person speci- yses, recorded observations, moni- fies the identity of the substance, and toring data, measurements, and con- controls the total amount produced clusions from a test or experiment. and the basic technology for the plant (gg) Test marketing means the dis- process, that person must submit the tribution in commerce of no more than notice. If it is unclear who must report, a predetermined amount of a chemical EPA should be contacted to determine substance, mixture, or article con- who must submit the notice. taining that chemical substance or (3) Only manufacturers that are in- mixture, by a manufacturer or proc- corporated, licensed, or doing business essor, to no more than a defined num- in the United States may submit a no- ber of potential customers to explore tice. market capability in a competitive sit- (b)(1) Any person who intends to im- uation during a predetermined testing port a new chemical substance into the period prior to the broader distribution United States for commercial purposes of that chemical substance, mixture, or must submit a notice, unless the sub- article in commerce. stance is excluded under § 720.30 or un- (hh) United States, when used in the less the substance is imported as part geographic sense, means all of the of an article. States. (2) When several persons are involved (ii) Central Data Exchange or CDX in an import transaction, the notice means EPA’s centralized electronic must be submitted by the principal im- document receiving system, or its suc- porter. If no one person fits the prin- cessors. cipal importer definition in a par- (jj) e-PMN software means electronic- ticular transaction, the importer PMN software created by EPA for use should contact EPA to determine who in preparing and submitting must submit the notice for that trans- Premanufacture Notices (PMNs) and action.

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§ 720.25 Determining whether a chem- stance isolation/purification, formu- ical substance is on the Inventory. lating, product development, process (a) A new chemical substance is any development, end-use application, tox- chemical substance that is not cur- icity testing, etc.). The person must rently listed on the Inventory. also indicate whether any pilot plant (b)(1) A chemical substance is listed or production-scale plant evaluations in the public portion of the Inventory have been conducted involving the by a specific chemical name (either a manufacture or processing of the sub- Chemical Abstracts (CA) Index Name stance. or a CA Preferred Name) and a Chem- (B) If an importer is unable to pro- ical Abstracts Service (CAS) Registry vide the information requested in para- Number if its identity is not confiden- graph (b)(2)(iii)(A) of this section from tial. If its identity is confidential, it is the foreign manufacturer or supplier, listed in the public portion of the In- the following information shall be sub- ventory by a TSCA Accession Number mitted: and a generic chemical name that (1) A brief statement indicating how masks the specific substance identity. long the substance has been in com- The confidential substance is listed by mercial use outside of the United its specific chemical name only in the States. confidential portion of the Inventory, (2) The name of a country in which it which is not available to the public. A has been commercially used. person who intends to manufacture or (3) Whether the importer believes import a chemical substance not listed that the substance has already been by specific chemical name in the public used commercially, in any country, for portion of the Inventory may ask EPA the same purpose or application that whether the substance is included in the importer is intending. the confidential Inventory. EPA will answer such an inquiry only if EPA de- (iv) A specific description of the major intended application or use of termines that the person has a bona the substance. fide intent to manufacture or import the chemical substance for commercial (v) An infrared spectrum of the sub- purposes. stance, or alternative spectra or other (2) To establish a bona fide intent to data which identify the substance if in- manufacture or import a chemical sub- frared analysis is not suitable for the stance, the person who proposes to substance or does not yield a reason- manufacture or import the substance able amount of structural information. must submit to EPA: When using alternative spectra or in- (i) Except as provided in paragraphs strumental analysis, the person must (b)(3) (i) and (ii) of this section, the submit a spectrum or instrumental specific chemical identity of the sub- readout for the substance. stance that the person intends to man- (vi) The estimated date (month/year) ufacture or import, using the cur- in which the person intends to submit rently, correct CA name for the sub- a Premanufacture Notice (PMN) for stance and the other correct chemical this substance if EPA informs the no- identity information in accordance tice submitter that the substance is with §§ 720.45(a) (1), (2), and (3). not on the Inventory. (ii) A signed statement that the per- (vii) The address of the facility under son intends to manufacture or import the control of the submitter at which that chemical substance for commer- the manufacture or processing of the cial purposes. substance would most likely occur. For (iii)(A) A brief description of the re- an imported substance, the facility search and development activities con- under the control of the importer at ducted to date related to the sub- which processing of the substance stance, including the year in which the would likely occur, if any. person first started to conduct research (viii)(A) For substances intended to or development activity on the sub- be manufactured in the United States, stance, and the general types of re- a description of the most probable search and development activities con- manufacturing process that would be ducted thus far (e.g., synthesis, sub- used by the submitter to produce the

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substance for non-exempt commercial the information requested for the con- purposes. fidential chemical substance under (B) For substances intended to be im- § 710.7(e)(2)(v) of this chapter or the in- ported, a brief description of how the formation requested under submitter is most likely to process or § 720.85(b)(3)(iii). use the substance for a commercial (5) If the proposed manufacturer or purpose. If the substance is not ex- importer has shown a bona fide intent pected to be processed or used at any to manufacture or import the sub- facility under the importer’s control, a stance, and provide sufficient unambig- statement to this effect must be in- uous chemical identity information so cluded along with a description of how EPA can make a conclusive determina- the substance will be processed or used tion of the chemical substance’s Inven- at sites controlled by others, if this in- tory status, EPA will search the con- formation is known or reasonably as- fidential Inventory and inform the pro- certainable. posed manufacturer or importer wheth- (3)(i) If an importer cannot provide er the chemical substance is on the the chemical identity information re- confidential Inventory. quired by paragraph (b)(2) (i) and (v) of (6) If the chemical substance is found this section because it is claimed con- on the confidential Inventory, EPA fidential by its foreign manufacturer or will notify the person(s) who originally supplier, the foreign manufacturer or reported the chemical substance that supplier must supply the required in- another person has demonstrated a formation directly to EPA in accord- bona fide intent to manufacture or im- ance with § 720.45(a) (1), (2), and (3) and port the substance and therefore was reference the importer’s notice. If the told that the chemical substance is on appropriate supporting document from the Inventory. the foreign party is not received within (7) A disclosure of a confidential 30 days after EPA receives the import- chemical identity to a person with a er’s notice, the notice will be consid- bona fide intent to manufacture or im- ered incomplete. port the particular chemical substance (ii) If a manufacturer cannot provide will not be considered a public disclo- all of the required information in ac- sure of confidential business informa- cordance with § 720.45(a) (1), (2), and (3) tion under section 14 of the Act. because the new chemical substance is (8) EPA will answer an inquiry on manufactured using a reactant that whether a particular chemical sub- has a specific chemical identity stance is on the confidential Inventory claimed as confidential by its supplier, within 30 days after receipt of a com- the notice must contain chemical iden- plete submission under paragraph (b)(2) tity information that is as complete as of this section. known by the manufacturer. In addi- (9) If the required chemical identity tion, a letter of support for the notice information has not been reported cor- must then be sent to EPA by the chem- rectly or completely in the notice (ex- ical supplier of the confidential cept as provided under paragraph reactant, providing the specific chem- (b)(3)(ii) of this section) or if any other ical identity of the proprietary required data or information has been reactant. The letter of support must omitted or is incomplete, EPA will reference the manufacturer’s notice. If consider the whole notice to be incom- the appropriate supporting document plete. As soon as an incomplete notice from the supplier is not received within is identified as such by EPA, the Agen- 30 days after EPA receives the manu- cy will immediately return the notice facturer’s notice, the notice will be directly to the submitter. The sub- considered incomplete. mitter must then resubmit the whole, (4) EPA will review the information completed bona fide notice to EPA in submitted by the proposed manufac- order to have the Agency perform the turer or importer under this paragraph desired Inventory search and respond to determine whether it has a bona fide to the notice. intent to manufacture or import the [48 FR 21742, May 13, 1983, as amended at 58 chemical substance. If necessary, EPA FR 34204, June 23, 1993; 60 FR 16309, Mar. 29, will compare this information either to 1995]

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§ 720.30 Chemicals not subject to noti- substance, mixture, or article of which fication requirements. they are a part.) The following substances are not sub- (1) Any impurity. ject to the notification requirements of (2) Any byproduct which is not used this part: for commercial purposes. (a) Any substance which is not a (3) Any chemical substance which re- ‘‘chemical substance’’ as defined in sults from a chemical reaction that oc- § 720.3(e). curs incidental to exposure of another (b) Any mixture as defined in chemical substance, mixture, or article § 720.3(u). 1 to environmental factors such as air, (c) Any new chemical substance moisture, microbial organisms, or sun- which will be manufactured or im- light. ported in small quantities solely for re- (4) Any chemical substance which research and development under § 720.36. sults from a chemical reaction that oc- (d) Any new chemical substance curs incidental to storage or disposal of which will be manufactured or im- another chemical substance, mixture, ported solely for test-marketing pur- or article. poses under an exemption granted (5) Any chemical substance which re- under § 720.38. sults from a chemical reaction that oc- (e) Any new chemical substance man- curs upon end use of another chemical ufactured solely for export if, when the substance, mixture, or article such as substance is distributed in commerce: an adhesive, paint, miscellaneous (1) The substance is labeled in ac- cleanser or other housekeeping prod- cordance with section 12(a)(1)(B) of the uct, fuel additive, water softening and Act. treatment agent, photographic film, (2) The manufacturer knows that the battery, match, or safety flare, and person to whom the substance is being which is not itself manufactured or im- distributed intends to export it or proc- ported for distribution in commerce or ess it solely for export as defined in for use as an intermediate. § 721.3 of this chapter. (6) Any chemical substance which re- (f) Any new chemical substance sults from a chemical reaction that oc- which is manufactured or imported curs upon use of curable plastic or rub- under the terms of a rule promulgated ber molding compounds, inks, drying under section 5(h)(4) of the Act. oils, metal finishing compounds, adhe- (g) Any byproduct if its only com- sives, or paints, or any other chemical mercial purpose is for use by public or substance formed during the manufac- private organizations that (1) burn it ture of an article destined for the mar- as a fuel, (2) dispose of it as a waste, in- ketplace without further chemical cluding in a landfill or for enriching soil, or (3) extract component chemical change of the chemical substance ex- substances from it for commercial pur- cept for those chemical changes that poses. (This exclusion only applies to occur as described elsewhere in this the byproduct; it does not apply to the paragraph. component substances extracted from (7) Any chemical substance which re- the byproduct.) sults from a chemical reaction that oc- (h) The chemical substances de- curs when (i) a stabilizer, colorant, scribed below: (Although they are man- odorant, antioxidant, filler, solvent, ufactured for commercial purposes carrier, surfactant, plasticizer, corro- under the Act, they are not manufac- sion inhibitor, antifoamer or defoamer, tured for distribution in commerce as dispersant, precipitation inhibitor, chemical substances per se and have no binder, emulsifier, deemulsifier, commercial purpose separate from the dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutralizer, sequesterant, co- 1 A new chemical substance that is manu- agulant, flocculant, fire retardant, lu- factured or imported as part of a mixture is subject to the requirements of this part. This bricant, chelating agent, or quality exclusion applies only to a mixture as a control reagent functions as intented, whole and not to any chemical substances or (ii) a chemical substance, which is which are part of the mixture. intended solely to impart a specific

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physiochemical characteristic, func- sonably be associated with such expo- tions as intended. sure. (8) Any nonisolated intermediate. (ii) Information provided to the man- (i) Any chemical substance which is ufacturer or importer by a supplier or manufactured solely for non-commer- any other person concerning a health cial research and development pur- risk believed to be associated with the poses. Non-commercial research and substance. development purposes include sci- (iii) Health and environmental ef- entific experimentation, research, or fects data in its possession or control analysis conducted by academic, gov- concerning the substance. ernment, or independent not-for-profit (iv) Information on health effects research organizations (e.g., univer- which accompanies any EPA rule or sities, colleges, teaching hospitals, and order issued under sections 4, 5, or 6 of research institutes), unless the activity the Act that applies to the substance is for eventual commercial purposes. and of which the manufacturer or im- [48 FR 21742, May 13, 1983, as amended at 51 porter has knowledge. FR 15101, Apr. 22, 1986] (2) When the research and development activity is conducted solely in a § 720.36 Exemption for research and laboratory and exposure to the chem- development. ical substance is controlled through (a) This part does not apply to a the implementation of prudent labora- chemical substance if the following tory practices for handling chemical conditions are met: substances of unknown toxicity, and (1) The chemical substance is manu- any distribution, except for purposes of factured or imported only in small disposal, is to other such laboratories quantities solely for research and de- for further research and development velopment. activity, the information specified in (2) The manufacturer or importer no- paragraph (b)(1) of this section need tifies all persons in its employ or to not be reviewed and evaluated. (For whom it directly distributes the chem- purposes of this paragraph, a labora- ical substance, who are engaged in ex- tory is a contained research facility perimentation, research, or analysis on where relatively small quantities of the chemical substance, including the chemical substances are used on a non- manufacture, processing, use, trans- production basis, and where activities port, storage, and disposal of the sub- involve the use of containers for reac- stance associated with research and de- tions, transfers, and other handling of velopment activities, of any risk to substances designed to be easily manip- health, identified under paragraph (b) ulated by a single individual.) of this section, which may be associ- (c)(1) The manufacturer or importer ated with the substance. The notifica- must notify the persons identified in tion must be made in accordance with paragraph (a)(2) of this section by paragraph (c) of this section. means of a container labeling system, (3) The chemical substance is used conspicuous placement of notices in by, or directly under the supervision areas where exposure may occur, writ- of, a technically qualified individual. ten notification to each person poten- (b)(1) To determine whether notifica- tially exposed, or any other method of tion under paragraph (a)(2) of this sec- notification which adequately informs tion is required, the manufacturer or persons of health risks which the man- importer must review and evaluate the ufacturer or importer has reason to be- following information to determine lieve may be associated with the sub- whether there is reason to believe stance, as determined under paragraph there is any potential risk to health (b)(1) of this section. which may be associated with the (2) If the manufacturer or importer chemical substance: distributes a chemical substance man- (i) Information in its possession or ufactured or imported under this sec- control concerning any significant ad- tion to persons not in its employ, the verse reaction by persons exposed to manufacturer or importer must in the chemical substance which may rea- written form:

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(i) Notify those persons that the sub- § 720.38 Exemptions for test mar- stance is to be used only for research keting. and development purposes. (a) Any person may apply for an ex- (ii) Provide the notice of health risks emption to manufacture or import a specified in paragraph (c)(1) of this sec- new chemical substance for test mar- tion. keting. EPA may grant the exemption (3) The adequacy of any notification if the person demonstrates that the under this section is the responsibility chemical substance will not present an of the manufacturer or importer. unreasonable risk to injury to health (d) A chemical substance is not ex- or the environment as a result of the empt from reporting under this part if test marketing. any amount of the substance, including (b) Persons applying for a test-mar- as part of a mixture, is processed, dis- keting exemption should provide the tributed in commerce, or used, for any following information: commercial purpose other than re- (1) All existing data regarding health search and development, except where and environmental effects of the chem- the chemical substance is processed, ical substance, including physical/ distributed in commerce, or used only chemical properties or, in the absence as an impurity or as part of an article. of such data, a discussion of toxicity (e) Quantities of the chemical sub- based on structure-activity relation- stance, or of mixtures or articles con- ships (SAR) and relevant data on chem- taining the chemical substance, re- ical analogues. maining after completion of research (2) The maximum quantity of the and development activities may be: chemical substance which the appli- (1) Disposed of as a waste in accord- cant will manufacture or import for ance with applicable Federal, state, test marketing. and local regulations, or (3) The maximum number of persons (2) Used for the following commercial who may be provided the chemical sub- purposes: stance during test marketing. (i) Burning it as a fuel. (4) The maximum number of persons (ii) Reacting or otherwise processing who may be exposed to the chemical it to form other chemical substances substance as a result of test mar- for commercial purposes, including ex- keting, including information regard- tracting component chemical sub- ing duration and route of such expo- stances. sures. (f) Quantities of research and devel- (5) A description of the test-mar- opment substances existing solely as keting activity, including its length impurities in a product or incorporated and how it can be distinguished from into an article, in accordance with full-scale commercial production and paragraph (d) of this section, and quan- research and development. tities of research and development sub- (c) In accordance with section 5(h)(6) stances used solely for commercial pur- of the Act, after EPA receives an appli- poses listed in paragraph (e) of this sec- cation for exemption under this section, are not subject to the require- tion, the Agency will file with the Of- ments of paragraphs (a), (b), and (c) of fice of the Federal Register a notice this section, once research and develop- containing a summary of the informa- ment activities have been completed. tion provided in the application, to the extent it has not been claimed con- (g) A person who manufactures or im- fidential. ports a chemical substance in small (d) No later than 45 days after EPA quantities solely for research and de- receives an application, the Agency velopment is not required to comply will either approve or deny the applica- with the requirements of this section if tion. Thereafter, EPA will publish a the person’s exclusive intention is to notice in the FEDERAL REGISTER ex- perform research and development ac- plaining the reasons for approval or de- tivities solely for the purpose of deter- nial. mining whether the substance can be (e) In approving an application for used as a pesticide. exemption, EPA may impose any re- [51 FR 15102, Apr. 22, 1986] strictions necessary to ensure that the

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substance will not present an unrea- ronmental Protection Agency, OPPT sonable risk of injury to health and the Document Control Office (DCO), EPA environment as a result of test mar- East Bldg., 1201 Constitution Ave., keting. NW., Rm. 6428, Washington, DC 20004. [48 FR 21742, May 13, 1983, as amended at 58 (B) [Reserved] FR 34204, June 23, 1993] (ii) Submissions on optical disc—(A) Notices may be submitted as electronic Subpart C—Notice Form files on optical disc on or before April 6, 2012. All notices submitted as elec- § 720.40 General. tronic files on optical disc must be gen- (a) Use of the notice form; electronic erated using e-PMN reporting software submissions. (1) Each person who is re- and be completed through the finaliza- quired by subpart B of this part to sub- tion step of the software. Optical discs mit a notice must complete, sign, and containing electronic notices must be submit a notice containing the infor- submitted by courier to the Environ- mation in the form and manner speci- mental Protection Agency, OPPT Doc- fied in this paragraph. The information ument Control Office (DCO), EPA East submitted and all attachments (unless Bldg., 1201 Constitution Ave., NW., Rm. the attachment appears in the open 6428, Washington, DC 20004. scientific literature) must be in (B) Persons submitting on optical English. All information submitted disc must also complete and submit on must be true and correct. paper the Certification and Submitter (2) All notices must be submitted on Identification sections of EPA Form EPA Form 7710–25. Notices, and any 7710–25. support documents related to these no- (iii) Submissions via CDX. Notices and tices, may only be submitted in a man- any related support documents may be ner set forth in this paragraph. submitted electronically to EPA via (i) Paper-based submissions. Notices, CDX. Prior to submission to EPA via and any support documents related to CDX, such notices must be generated these notices, may be submitted on and completed on EPA Form 7710–25 paper on or before April 6, 2011. All using e-PMN reporting software. To ob- paper-based notices must be generated tain a version of e-PMN software that using e-PMN reporting software and be contains an encryption module you completed through the finalization must register with CDX. A version step of the software, and e-PMN soft- without encryption may be downloaded ware must be used to print EPA Form without registering with CDX. 7710–25 for submission to EPA. Paper (iv) You can obtain the e-PMN soft- notices, and any support documents re- ware as follows: lated to such notices, must be sub- (A) Website. Go to EPA’s TSCA New mitted either via U.S. mail to the Doc- Chemicals Program website at http:// ument Control Office (DCO) (7407M), www.epa.gov/oppt/newchems and follow Office of Pollution Prevention and the appropriate links. Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., (B) Telephone. Call the EPA CDX Washington, DC 20460–0001 or submitted Help Desk at 1–888–890–1995. via courier to the Environmental Pro- (C) E-mail. [email protected]. tection Agency, OPPT Document Con- (b) When to submit a notice. Each per- trol Office (DCO), EPA East Bldg., 1201 son who is required to submit a notice Constitution Ave., NW., Rm. 6428, must submit the notice at least 90 cal- Washington, DC 20004. endar days before manufacture or im- (A) Support documents for notices port of the new chemical substance for that are submitted before April 6, 2010 commercial purposes begins. must be submitted on paper either via (c) Where to submit a notice or support U.S. mail to the Document Control Of- documents. For submitting notices or fice (DCO) (7407M), Office of Pollution support documents via CDX, use the e- Prevention and Toxics, Environmental PMN software. Paper notices or sup- Protection Agency, 1200 Pennsylvania port documents must be submitted ei- Ave., NW., Washington, DC 20460–0001 ther via U.S. mail to the Document or submitted via courier to the Envi- Control Office (DCO) (7407M), Office of

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Pollution Prevention and Toxics, Envi- the information to EPA using either ronmental Protection Agency, 1200 the notice form or a Letter of Support, Pennsylvania Ave., NW., Washington, except that if the joint submitter is DC 20460–0001 or submitted via courier not incorporated, licensed, or doing to the Environmental Protection Agen- business in the United States, the joint cy, OPPT Document Control Office submitter must submit the informa- (DCO), EPA East Bldg., 1201 Constitu- tion to EPA in a Letter of Support tion Ave., NW., Rm. 6428, Washington, only, not in a notice form. The joint DC 20004. Optical discs containing elec- submitter must indicate in the notice tronic notices or support documents or Letter of Support the identity of the must be submitted by courier to the manufacturer or importer. Any person Environmental Protection Agency, who submits a notice form or Letter of OPPT Document Control Office (DCO), Support for a joint submission must EPA East Bldg., 1201 Constitution Ave., sign and certify the notice form or Let- NW., Rm. 6428, Washington, DC 20004. ter of Support. Persons submitting on optical disc (3) Only the Authorized Official (AO) must also complete and submit on of a company can submit all TSCA sec- paper the Certification and Submitter tion 5 documents. Identification sections of EPA Form (i) The AO can authorize other per- 7710–25. sons to submit only support documents (d) General notice requirements. (1) on their behalf. Each person who submits a notice must (ii) To authorize a support registrant provide the information described in to submit support documents, both the § 720.45 and specified on the notice AO and support registrant must sign form, to the extent such information is the ‘‘Authorization and Verification known to or reasonably ascertainable for Section 5 Notice Support Submitter by the person. In accordance with by Company Authorizing Official’’ § 720.50, the notice must also include available from the CDX website at any test data in the person’s possession http://cdx.epa.gov/epalhome.asp. or control, and descriptions of other (f) New information. During the notice data which are known to or reasonably review period, if the submitter pos- ascertainable by the person and which sesses, controls, or knows of new infor- concern the health and environmental mation that materially adds to, effects of the new chemical substance. changes, or otherwise makes signifi- (2) If information is claimed as con- cantly more complete the information fidential pursuant to § 720.80, a person included in the notice, the submitter who submits a notice to EPA in the must that information to the address manner set forth in § 720.40(a)(2)(i), (ii), listed on the notice form within ten or (iii) must also provide EPA with a days of receiving the new information, sanitized copy. but no later than five days before the (e) Agency or joint submissions—(1) A end of the notice review period. The manufacturer or importer may des- new submission must clearly identify ignate an agent to assist in submitting the submitter and the notice to which the notice. If so, only the manufacturer the new information is related. If the or importer, and not the agent, signs new information becomes available the certification on the form. during the last five days of the notice (2) A manufacturer or importer may review period, the submitter must im- authorize another person, (e.g., a sup- mediately inform its EPA contract for plier or a toll manufacturer) to report that notice by telephone. some of the information required in the (g) Chemical substances subject to a sec- notice to EPA on its behalf. The manu- tion 4 test rule. (1) Except as provided in facturer or importer should indicate in paragraph (g)(3) of this section, if (i) A a cover letter accompanying the notice person intends to manufacture or im- which information will be supplied by port a new chemical substance which is another person and must identify that subject to the notification require- other person as a joint submitter where ments of this part, and (ii) The chem- indicated on their notice form. The ical substance is subject to a test rule other person supplying information promulgated under section 4 of the Act (i.e., the joint submitter) may submit before the notice is submitted, section

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5(b)(1) of the Act requires the person to § 720.45 Information that must be in- submit the test data required by the cluded in the notice form. testing rule with the notice. The per- Each person who submits a notice son must submit the data in the form must include the information specified and manner specified in the test rule in the notice form to the extent it is and in accordance with § 720.50. If the known to or reasonably ascertainable person does not submit the test data, by the submitter. However, no person the submission is incomplete and EPA is required to include information will follow the procedures in § 720.65. which relates solely to exposure of (2) If EPA has granted the submitter human or ecological populations out- an exemption under section 4(c) of the side of the United States. The notice Act from the requirement to conduct form requires the following informa- tests and submit data, the submitter tion relating to the manufacture, proc- may not submit a notice until EPA re- essing, distribution in commerce, use, ceives the test data. and disposal of the new chemical sub- (3) If EPA has granted the submitter stance: an exemption under section 4(c) of the (a)(1) The specific chemical identity Act and if another person previously of the substance that the person in- has submitted the test data to EPA, tends to manufacture or import, which the exempted person may either sub- includes the following: mit the test data or provide the fol- (i) The currently correct Chemical lowing information as part of the no- Abstracts (CA) name for the substance, tice: based on the Ninth Collective Index (i) The name, title, and address of the (9CI) of CA nomenclature rules and person who submitted the test data to conventions, and consistent with list- EPA. ings for similar substances in the In- (ii) The date the test data were sub- ventory. For each substance having a mitted to EPA. chemical composition that can be rep- (iii) A citation for the test rule. resented by a specific, complete chem- (iv) A description of the exemption ical structure diagram (a Class 1 sub- and a reference identifying it. stance), a CA Index Name must be pro- (h) Chemical substances subject to a vided. For each chemical substance section 5(b)(4) rule. (1) If a person (i) in- that cannot be fully represented by a tends to manufacture or import a new complete, specific chemical structure chemical substance which is subject to diagram (a Class 2 substance), or if the the notification requirements of this substance is a polymer, a CA Index part and which is subject to a rule Name or CA Preferred Name must be issued under section 5(b)(4) of the Act; provided (whichever is appropriate and (ii) is not required by a rule issued based on CA 9CI nomenclature rules under section 4 of the Act to submit and conventions). In addition, for a test data for the substance before the Class 2 substance, the notice must submission of a notice, the person must identify the immediate chemical pre- submit to EPA data described in para- cursors and reactants by specific chem- graph (h)(2) of this section at the time ical name and Chemical Abstracts the notice is submitted. Service Registry Number (CASRN), if (2) Data submitted under paragraph the number is available. Tradenames or (h)(1) of this section must be data generic names of chemical precursors which the person submitting the notice or reactants are not acceptable as sub- believes show that the manufacture, stitutes for specific chemical names. processing, distribution in commerce, (ii) The currently correct CASRN for use and disposal of the substance, or the substance if a CASRN already ex- any combination of such activities, ists for the substance. will not present an unreasonable risk (iii) For a Class 1 substance and for of injury to health or the environment. any Class 2 substance for which a defi- [48 FR 21742, May 13, 1983, as amended at 58 nite molecular formula is known or FR 34204, June 23, 1993; 60 FR 16309, Mar. 29, reasonably ascertainable, the correct 1995; 75 FR 784, Jan. 6, 2010] molecular formula.

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(iv) For a Class 1 substance, a com- amount of low molecular weight spe- plete, correct chemical structure dia- cies below 500 and below 1,000 molec- gram; for a Class 2 substance or poly- ular weight, with a description of how mer, a correct representative or partial the measured or estimated values were chemical structure diagram, as com- obtained. plete as can be known, if one can be (3) The person must use one of the reasonably ascertained. following two methods to develop or (2) For a polymer, the submitter obtain the specified chemical identity must also report the following: information reported under paragraphs (i) The specific chemical name and (a) (1) and (2) of this section and must CASRN, if the number is available, of identify the method used in the notice: each monomer and other reactant used, (i) Method 1. Obtain the correct at any weight percent, to manufacture chemical identity information required the polymer. Tradenames or generic by paragraphs (a) (1) and (2) of this sec- names of chemical reactants or mono- tion directly from the Chemical Ab- mers are not acceptable as substitutes stracts Service (CAS), specifically from for specific chemical names. the CAS Registry Services Inventory (ii) The typical percent by weight of Expert Service, prior to submitting a each monomer and other reactant in notice to EPA. A copy of the chemical the polymer (weight of the monomer or identification report obtained from other reactant expressed as a percent- CAS must be submitted with the no- age of the weight of the polymeric tice. chemical substance manufactured), and (ii) Method 2. Obtain the correct the maximum residual amount of each chemical identity information required monomer present in the polymer. by paragraphs (a) (1) and (2) from any (iii) For monomers and other source. The notice will be incomplete reactants used at 2 weight percent or according to § 720.65(c)(1)(vi) if the per- less (based on the dry weight of the son uses Method 2 and any chemical polymer manufactured), indicate on identity information is determined to the PMN form any such monomers and be incorrect by EPA. other reactants that should be included (4) If an importer submitting the no- as part of the polymer description on tice cannot provide all the information the Inventory, where the weight per- specified in paragraphs (a) (1) and (2) of cent is based on either (A) the weight this section because it is claimed as of monomer or other reactant actually confidential by the foreign supplier of charged to the reaction vessel, or (B) the substance, the importer must have the minimum weight of monomer or the foreign supplier follow the proce- other reactant required in theory to dures in paragraph (a)(3) of this section account for the actual weight of mon- and provide the correct chemical iden- omer or other reactant molecules or tity information specified in para- fragments chemically incorporated graphs (a) (1) and (2) of this section di- (chemically combined) in the poly- rectly to EPA in a joint submission or meric substance manufactured. as a letter of support to the notice, (iv) For a determination that 2 which clearly references the importer’s weight percent or less of a monomer or notice and PMN User Fee Identifica- other reactant is incorporated (chemi- tion Number. The statutory review cally combined) in a polymeric sub- process will commence upon receipt of stance manufactured, as specified in both the notice and the complete, cor- paragraphs (a)(2)(iii)(B) of this section, rect information. analytical data or appropriate theo- (5) If a manufacturer cannot provide retical calculations (if it can be docu- all the information specified in para- mented that analytical measurement is graphs (a) (1) and (2) of this section be- not feasible or not necessary) to sup- cause the new chemical substance is port this determination must be main- manufactured using a reactant having tained at the site of manufacture or a specific chemical identity claimed as import of the polymer. confidential by its supplier, the manu- (v) Measured or estimated values of facturer must submit a notice directly the minimum number-average molec- to EPA containing all the information ular weight of the polymer and the known by the manufacturer about the

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chemical identity of the reported sub- (4) Information on release of the new stance and its proprietary reactant. In substance to the environment, includ- addition, the manufacturer must en- ing the quantity and media of release sure that the supplier of the confiden- and type of control technology used. tial reactant submit a letter of support (h) For sites not controlled by the directly to EPA providing the specific submitter, a description of each type of chemical identity of the confidential processing and use operation involving reactant, including the CAS number, if the new chemical substance, including available, and the appropriate PMN or identification of the estimated number exemption number, if applicable. The of processing or use sites, situations in letter of support must reference the which worker exposure to and/or envi- manufacturer’s name and PMN User ronmental release of the new chemical Fee Identification Number under substance will occur, the number of § 700.45(c)(3) of this chapter. The statu- workers exposed and the duration of tory review period will commence upon exposure, and controls which limit receipt of both the notice and the let- worker exposure and environmental re- ter of support. lease. (b) The impurities anticipated to be [48 FR 21742, May 13, 1983, as ameneded at 60 present in the substance by name, CAS FR 16310, Mar. 29, 1995] Registry number, and weight percent of the total substance. § 720.50 Submission of test data and (c) Known synonyms or trade names other data concerning the health of the new chemical substance. and environmental effects of a sub- (d) A description of the byproducts stance. resulting from the manufacture, proc- (a) Test data on the new chemical sub- essing, use, and disposal of the new stance in the possession or control of the chemical substance. submitter. (1) Except as provided in (e) The estimated maximum amount paragraph (d) of this section, each no- to be manufactured or imported during tice must contain all test data in the the first year of production and the es- submitter’s possession or control which timated maximum amount to be manu- are related to the effects on health or factured or imported during any 12- the environment of any manufacture, month period during the first three processing, distribution in commerce, years of production. use, or disposal of the new chemical (f) A description of intended cat- substance or any mixture or article egories of use by function and applica- containing the new chemical sub- tion, the estimated percent of produc- stance, or any combination of such action volume devoted to each category tivities. This includes test data con- of use, and the percent of the new sub- cerning the new chemical substance in stance in the formulation for each a pure, technical grade, or formulated commercial or consumer use. form. (g) For sites controlled by the sub- (2) A full report or standard lit- mitter: erature citation must be submitted for (1) The identity of sites where the the following types of test data: new substance will be manufactured, (i) Health effects data. processed, or used. (ii) Ecological effects data. (2) A process description of each man- (iii) Physical and chemical properties ufacture, processing, and use operation data. which includes a diagram of the major (iv) Environmental fate characteris- unit operations and chemical conver- tics. sions, the identity and entry point of (v) Monitoring data and other test all feedstocks, and the points of release data related to human exposure to or of the new chemical substance. environmental release of the chemical (3) Worker exposure information, in- substance. cluding worker activities, physical (3)(i) If the data do not appear in the form of the new substance to which open scientific literature, the sub- workers may be exposed, the number of mitter must provide a full report. A workers, and the duration of activities. full report includes the experimental

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methods and materials, results, discus- essing, distribution in commerce, use, sion and data analysis, conclusions, or disposal of the new chemical sub- references, and the name and address of stance, of any mixture or article con- the laboratory that developed the data. taining the new chemical substance, or (ii) If the data appear in the open sci- of any combination of such activities: entific literature, the submitter need (i) Any data, other than test data, in only provide a standard literature cita- the submitter’s possession or control. tion. A standard literature citation in- (ii) Any data, including test data, cludes author, title, periodical name, which are not in the submitter’s pos- date of publication, volume, and page session or control, but which are numbers. known to or reasonably ascertainable (4)(i) If a study, report, or test is in- by the submitter. For the purposes of complete when a person submits a no- this section, data are known to or rea- tice, the submitter must identify the sonably ascertainable by the submitter nature and purpose of the study; name if the data are known to any of its em- and address of the laboratory devel- ployees or other agents who are associ- oping the data; progress to date; types ated with the research and develop- of data collected; significant prelimi- ment, test marketing, or commercial nary results; and anticipated comple- marketing of the substance. tion date. (2) Data that must be described in- (ii) If a test or experiment is com- clude data concerning the new chem- pleted before the notice review period ical substance in a pure, technical ends, the person must submit the grade, or formulated form. study, report, or test to the address (3) The description of data reported listed on the notice form, as specified under this paragraph must include: in paragraph (a)(3)(i) of this section, within ten days of receiving it, but no (i) If the data appear in the open sci- later than five days before the end of entific literature, a standard literature the review period. If the test or experi- citation, which includes the author, ment is completed during the last five title, periodical name, date of publica- days of the review period, the sub- tion, volume, and pages. mitter must immediately inform its (ii) If the data are not contained in EPA contact for that notice by tele- the open scientific literature, a de- phone. scription of the type of data and sum- (5) For test data in the submitter’s mary of the results, if available, and possession or control which are not the names and addresses of persons the listed in paragraph (a)(2) of this sec- submitter believes may have possession tion, a person is not required to submit or control of the data. a complete report. The person must (4) All data described by this para- submit a summary of the data. If EPA graph are subject to these require- so requests, the person must submit a ments, regardless of their age, quality, full report within ten days of the re- or results; and regardless of whether quest, but no later than five days be- they are complete at the time the no- fore the end of the review period. tice is submitted. (6) All test data described by para- (c) [Reserved] graph (a) are subject to these require- (d) Data that need not be submitted—(1) ments, regardless of their age, quality, Data previously submitted to EPA. (i) A or results. person need not submit any data pre- (b) Other data concerning the health viously submitted to EPA with no and environmental effects of the new claims of confidentiality if the notice chemical substance that are known to or includes the office or person to whom reasonably ascertainable by the submitter. the data were submitted, the date of (1) Except as provided in paragraph (d) submission, and, if appropriate, a of this section, any person who submits standard literature citation as speci- a notice must describe the following fied in paragraph (a)(3)(ii) of this sec- data, including any data from a health tion. and safety study, if the data are re- (ii) For data previously submitted to lated to the effects on health or the en- EPA with a claim of confidentiality, vironment of any manufacture, proc- the person must resubmit the data

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with the notice and any claim of con- that the submission is not a notice fidentiality, under § 720.80. under this part. (2) Efficacy data. This part does not [48 FR 21742, May 13, 1983, as amended at 58 require submission of any data related FR 34204, June 23, 1993] solely to product efficacy. This does not exempt a person from submitting § 720.65 Acknowledgement of receipt any of the data specified in paragraph of a notice; errors in the notice; in- (a), (b), or (c) of this section. complete submissions; and false (3) Non-U.S. exposure data. This part and misleading statements. does not require submission of any (a) Notification to the submitter. EPA data which relates only to exposure of will acknowledge receipt of each notice humans or the environment outside the by sending a letter via CDX or U.S. United States. This does not exclude mail to the submitter that identifies nonexposure data such as data on the premanufacture notice number as- health effects (including epidemiolog- signed to the new chemical substance ical studies), ecological effects, phys- and date on which the review period be- ical and chemical properties, or envi- gins. The review period will begin on ronmental fate characteristics. the date the notice is received by the [48 FR 21742, May 13, 1983, as amended at 51 Office of Pollution Prevention and FR 15102, Apr. 22, 1986] Toxics Document Control Officer. The acknowledgment does not constitute a § 720.57 Imports. finding by EPA that the notice, as sub- (a) Except as otherwise provided in mitted, is in compliance with this part. this section, the provisions of this sub- (b) Errors in the notice. (1) Within 30 part C apply to each person who sub- days of receipt of the notice, EPA may mits a notice for a new chemcial sub- request that the submitter remedy er- stance which he or she intends to im- rors in the notice. The following are port for a commercial purpose. In addi- examples of such errors: tion, each importer must comply with (i) Failure to date the notice form. this section. (ii) Typographical errors that cause (b) EPA will hold the principal im- data to be misleading or answers to porter, or the importer that EPA deter- any questions to be unclear. mines must submit the notice when (iii) Contradictory information. there is no principal importer under (iv) Ambiguous statements or infor- § 720.22(b)(2), liable for complying with mation. this part, for completing the notice (2) In the request to correct the no- form and for the completeness and tice, EPA will explain the action which truthfulness of all information which it the submitter must take to correct the submits. notice. (3) If the submitter fails to correct Subpart D—Disposition of Notices the notice within 15 days of receipt of the request, EPA may extend the no- § 720.60 General. tice period under section (5)(c) of the This subpart establishes procedures Act, in accordance with § 720.75(c). that EPA will follow in reviewing no- (c) Incomplete submissions. (1) A sub- tices. mission is not complete, and the notification period does not begin, if: § 720.62 Notice that notification is not (i) The wrong person submits the no- required. tice form. When EPA receives a notice, EPA (ii) The submitter does not sign the will review it to determine whether the notice form. chemical substance is subject to the re- (iii) Some or all of the information in quirements of this part. If EPA deter- the notice or the attachments are not mines that the chemical substance is in English, except for published sci- not subject to these requirements, EPA entific literature. will notify the submitter that section 5 (iv) The submitter does not submit of the Act does not prevent the manu- the notice in the manner set forth in facture or import of the substance and § 720.40(a)(2).

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(v) The submitter does not provide requesting modification of the require- information that is required by section ments for completing the submission. 5(d)(1) (B) and (C) of the Act and (4) Within ten days after receipt of § 720.50. notification by EPA that a submission (vi) The submitter does not provide is incomplete, the submitter may file information required on the notice written objections requesting that EPA form and by § 720.45 or indicate that it accept the submission as a complete is not known to or reasonably ascer- notice or modify the requirements nec- tainable by the submitter. essary to complete the submission. (vii) The submitter does not submit a (5)(i) EPA will consider the objec- second copy of the submission with all tions filed by the submitter. The Direc- confidential information deleted for tor, or his or her delegate, will deter- the public file, as required by mine whether the submission was com- § 720.80(b)(2). plete or incomplete, or whether to (viii) The submitter does not include modify the requirements for com- any information required by section pleting the submission. EPA will notify 5(b)(1) of the Act and pursuant to a rule the submitter in writing of EPA’s re- promulgated under section 4 of the Act, sponse within ten days of receiving the as required by § 720.40(g). objections. (ix) The submitter does not submit (ii) If the Director, or his or her dele- data which the submitter believes show gate, determines, in response to the ob- that the chemical substance will not jection, that the submission was com- present an unreasonable risk of injury plete, the notice review period will be to health or the environment, if EPA deemed suspended on the date EPA de- has listed the chemical substance clared the notice incomplete, and will under section 5(b)(4) of the Act, as re- resume on the date that the notice is quired in § 720.40(h). declared complete. The submitter need (x) The submitter does not include an not correct the notice as EPA origi- identifying number and a payment nally requested. If EPA can complete identity number as required by 40 CFR its review within 90 days from the date 700.45(e)(3). of the original submission, the Direc- (2)(i) If EPA receives an incomplete tor, or his or her delegate, may inform submission, the Director, or his or her the submitter that the running of the delegate, will notify the submitter review period will resume on the date within 30 days of receipt that the sub- EPA originally declared it incomplete. mission is incomplete and that the no- (iii) If the Director, or his or her del- tice review period will not begin until egate, modifies the requirements for EPA receives a complete notice. completing the submission or concurs (ii) If EPA obtains additional infor- with EPA’s original determination, the mation during the notice review period notice review period will begin when that indicates the original submission EPA receives a complete notice. was incomplete, the Director, or his or (d) Materially false or misleading state- her delegate, may declare the submis- ments. If EPA discovers at any time sion incomplete within 30 days after that person submitted materially false EPA obtains the additional informa- or misleading statements in the notice, tion and so notify the submitter. EPA may find that the notice was in- (3) The notification that a submis- complete from the date it was sub- sion is incomplete under paragraph mitted, and take any other appropriate (c)(2) (i) or (ii) of this section will in- action. clude: [48 FR 21742, May 13, 1983, as amended at 75 (i) A statement of the basis of EPA’s FR 785, Jan. 6, 2010] determination that the submission is incomplete. § 720.70 Notice in the Federal Register. (ii) The requirements for correcting (a) Filing of FEDERAL REGISTER notice. the incomplete submission. In accordance with section 5(d)(2) of (iii) Information on procedures under the Act, after EPA receives a notice, paragraph (c)(4) of this section for fil- EPA will file with the Office of the ing objections to the determination or Federal Register a notice including the

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information specified in paragraph (b) (i) Older notices. Requests for suspen- of this section. sion for premanufacture notices sub- (b) Contents of notice. (1) In the public mitted before April 6, 2010 must be sub- interest, the specific chemical identity mitted on paper either via U.S. mail to listed in the notice will be published in the Document Control Office (DCO) the FEDERAL REGISTER unless the sub- (7407M), Office of Pollution Prevention mitter has claimed chemical identity and Toxics, Environmental Protection confidential. If the submitter claims Agency, 1200 Pennsylvania Ave., NW., confidentiality, a generic name will be Washington, DC 20460–0001 or submitted published in accordance with via courier to the Environmental Pro- § 720.85(a)(3). tection Agency, OPPT Document Con- (2) The categories of use of the new trol Office (DCO), EPA East Bldg., 1201 chemical substance will be published as Constitution Ave., NW., Rm. 6428, reported in the notice unless this infor- Washington, DC 20004. mation is claimed confidential. If con- (ii) Newer notices. For notices sub- fidentiality is claimed, the generic in- mitted on or after April 6, 2010, EPA formation which is submitted under will accept requests for suspension § 720.87(b) will be published. only if submitted in accordance with (3) A list of data submitted in accord- this paragraph: ance with § 720.50(a) will be published. (A) Requests for suspension may be In addition, for test data submitted in submitted on paper on or before April accordance with § 720.40(g), a summary 6, 2011. All paper-based requests for sus- of the data will be published. pension must be generated using e- (4) The submitter’s identity will be PMN reporting software and be com- published, unless the submitter has pleted through the finalization step of claimed it confidential. the software, and e-PMN software must be used to print the request for suspen- § 720.75 Notice review period. sion for submission to EPA. Paper re- (a) Length of notice review period. The quests for suspension must be sub- notice review period specified in sec- mitted either via U.S. mail to the Doc- tion 5(a) of the Act runs for 90 days ument Control Office (DCO) (7407M), from the date the Document Control Office of Pollution Prevention and Officer for the Office of Pollution Pre- Toxics, Environmental Protection vention and Toxics receives a complete Agency, 1200 Pennsylvania Ave., NW., notice, or the date EPA determines the Washington, DC 20460–0001 or submitted notice is complete under § 720.65(c), un- via courier to the Environmental Pro- less the Agency extends the period tection Agency, OPPT Document Con- under section 5(c) of TSCA and para- trol Office (DCO), EPA East Bldg., 1201 graph (c) of this section. Constitution Ave., NW., Rm. 6428, (b) Suspension of the running of the no- Washington, DC 20004. tice review period. (1) A submitter may voluntarily suspend the running of the (B) Requests for suspension may be notice review period if the Director or submitted as electronic files on optical his or her delegate agrees. If the Direc- disc on or before April 6, 2012. All re- tor does not agree, the review period quests for suspension submitted as will continue to run, and EPA will no- electronic files on optical disc gen- tify the submitter. A submitter may erated using e-PMN reporting software request a suspension at any time dur- and be completed through the finaliza- ing the notice review period. The sus- tion step of the software, and e-PMN pension must be for a specified period software must be used to print the re- of time. quest for suspension for submission to (2) A request for suspension may only EPA. Paper requests for suspension be submitted in a manner set forth in must be submitted either via U.S. mail this paragraph. The request for suspen- to the Document Control Office (DCO) sion also may be made orally, includ- (7407M), Office of Pollution Prevention ing by telephone, to the submitter’s and Toxics, Environmental Protection EPA contact for that notice, subject to Agency, 1200 Pennsylvania Ave., NW., paragraph (b)(3) of this section. Washington, DC 20460–0001 or submitted

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via courier to the Environmental Pro- (iii) EPA has received significant ad- tection Agency, OPPT Document Con- ditional information during the notice trol Office (DCO), EPA East Bldg., 1201 review period. Constitution Ave., NW., Rm. 6428, (iv) The submitter has failed to cor- Washington, DC 20004. rect a notice after receiving EPA’s re- (C) Requests for suspension may be quest under § 720.65(b). submitted electronically to EPA via (d) Notice of expiration of notice review CDX. Such requests must be generated period. EPA will notify the submitter and completed using e-PMN reporting that the notice review period has ex- software. See § 720.40(a)(2)(iv) for infor- pired or that EPA has completed its re- mation on how to obtain e-PMN soft- view of the notice. Expiration of the re- ware. view period does not constitute EPA (3) An oral request for suspension approval or certification of the new may be granted by EPA for a maximum chemical substance, and does not mean of 15 days only. Requests for a longer that EPA may not take regulatory ac- suspension must only be submitted in tion against the substance in the fu- the manner set forth in this paragraph. ture. After expiration of the statutory (4) If the submitter has not made a notice review period, in the absence of previous oral request, the running of regulatory action by EPA under sec- the notice review period is suspended tion 5(e), 5(f), or 6(a) of the Act, the as of the date of receipt of the written submitter may manufacture or import paper request, electronic request on op- the chemical substance even if the sub- tical disc, or CDX submission by EPA. mitter has not received notice of expi- (c) Extension of notice review period. (1) ration. At any time during the notice review (e) Withdrawal of a notice by the sub- period, EPA may determine that good mitter. (1) A submitter may withdraw a cause exists to extend the notice re- notice during the notice review period view period specified in paragraph (a) by submitting a statement of with- of this section. drawal in a manner set forth in this (2) If EPA makes such a determina- paragraph. The withdrawal is effective tion, EPA will: upon receipt of the written paper re- (i) Notify the submitter that EPA is quest, electronic request on optical extending the notice review period for disc, or CDX submission by EPA. a specified length of time, and state (i) Older notices. Statements of with- the reasons for the extension. drawal for premanufacture notices sub- (ii) Issue a notice for publication in mitted before April 6, 2010 must be sub- the FEDERAL REGISTER which states mitted on paper either via U.S. mail to that EPA is extending the notice re- the Document Control Office (DCO) view period and gives the reasons for (7407M), Office of Pollution Prevention the extension. and Toxics, Environmental Protection (3) The initial extension may be for a Agency, 1200 Pennsylvania Ave., NW., period of up to 90 days. If the initial ex- Washington, DC 20460–0001 or submitted tension is for less than 90 days, EPA via courier to the Environmental Pro- may make additional extensions. How- tection Agency, OPPT Document Con- ever, the total period of extensions trol Office (DCO), EPA East Bldg., 1201 may not exceed 90 days for any notice. Constitution Ave., NW., Rm. 6428, (4) The following are examples of sit- Washington, DC 20004. uations in which EPA may find that (ii) Newer notices. For notices sub- good cause exists for extending the no- mitted on or after April 6, 2010, EPA tice review period: will accept statements of withdrawal (i) EPA has reviewed the notice and only if submitted in accordance with determined that there is a significant this paragraph: possibility that the chemical substance (A) Statements of withdrawal may be will be regulated under section 5(e) or submitted on paper on or before April section 5(f) of the Act, but EPA is un- 6, 2011. All paper-based statements of able to initiate regulatory action with- withdrawal must be generated using e- in the initial 90-day period. PMN reporting software and be com- (ii) EPA has reviewed the submission pleted through the finalization step of and is seeking additional information. the software, and e-PMN software must

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be used to print the statement of with- five years from the date of commence- drawal for submission to EPA. Paper ment of manufacture of import. statements of withdrawal must be sub- (b)(1) Persons who manufacture or mitted either via U.S. mail to the Doc- import a chemical substance under ument Control Office (DCO) (7407M), § 720.36 must retain the following Office of Pollution Prevention and records: Toxics, Environmental Protection (i) Copies of, or citations to, informa- Agency, 1200 Pennsylvania Ave., NW., tion reviewed and evaluated under Washington, DC 20460–0001 or submitted § 720.36(b)(1) to determine the need to via courier to the Environmental Pro- make any notification of risk. tection Agency, OPPT Document Con- (ii) Documentation of the nature and trol Office (DCO), EPA East Bldg., 1201 method of notification under Constitution Ave., NW., Rm. 6428, § 720.36(c)(1) including copies of any la- Washington, DC 20004. bels or written notices used. (B) Statements of withdrawal may be (iii) Documentation of prudent lab- submitted as electronic files on optical oratory practices used instead of noti- disc on or before April 6, 2012. All state- fication and evaluation under ments of withdrawal submitted as elec- § 720.36(b)(2). tronic files on optical disc must be gen- (iv) The names and addresses of any erated using e-PMN reporting software persons other than the manfacturer or and be completed through the finaliza- importer to whom the substance is dis- tion step of the software. Optical discs tributed, the identity of the substance containing electronic statements of to the extent known, the amount dis- withdrawal must be submitted by cou- tributed, and copies of the notifica- rier to the Environmental Protection tions required under § 720.36(c)(2). These Agency, OPPT Document Control Of- records are not required when sub- fice (DCO), EPA East Bldg., 1201 Con- stances are distributed as impurities or stitution Ave., NW., Rm. 6428, Wash- incorporated into an article, in accord- ington, DC 20004. ance with paragraph (d) of this section. (C) Statements of withdrawal may be (2) A person who manufactures or im- submitted electronically to EPA via ports a chemical substance under CDX. Prior to submission to EPA via § 720.36 and who manufactures or im- CDX, such statements of withdrawal ports the substance in quantities great- must be generated and completed using er than 100 kilograms per year must re- e-PMN reporting software. See tain records of the identity of the sub- § 720.40(a)(2)(iv) for information on how stance to the extent known, the pro- to obtain e-PMN software. duction volume of the substance, and (2) If a manufacturer or importer the person’s disposition of the sub- which withdrew a notice later resub- stance. The person is not required to mits a notice for the same chemical maintain records of the disposition of substance, a new notice review period products containing the substance as begins. an impurity or of articles incor- porating the substances. [48 FR 21742, May 13, 1983, as amended at 53 FR 12523, Apr. 15, 1988; 58 FR 34204, June 23, (3) Records under this paragraph 1993; 60 FR 34464, July 3, 1995; 71 33641, June must be retained for 5 years after they 12, 2006; 75 FR 786, Jan. 6, 2010] are developed. (c) Any person who obtains a test- § 720.78 Recordkeeping. marketing exemption under this part (a) Any person who submits a notice must retain documentation of informa- under this part must retain docu- tion in the application and documenta- mentation of information in the notice, tion of compliance with any restric- including (1) other data, as defined in tions imposed by EPA when it granted § 720.50(b), in the submitter’s possession the application. This information must or control; and (2) records of produc- be retained for five years from the final tion volume for the first three years of date of manufacture or import under production or import, the date of com- the exemption. mencement of manufacture or import, [48 FR 21742, May 13, 1983; 48 FR 33872, July and documentation of this information. 26, 1983, as amended at 51 FR 15102, Apr. 22, This information must be retained for 1986; 58 FR 34204, June 23, 1993]

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Subpart E—Confidentiality and file without further notice to the sub- Public Access to Information mitter. [48 FR 21742, May 13, 1983, as amended at 58 § 720.80 General provisions. FR 34204, June 23, 1993; 60 FR 16311, Mar. 29, (a) A person may assert a claim of 1995; 75 FR 786, Jan. 6, 2010] confidentiality for any information which he or she submits to EPA under § 720.85 Chemical identity. this part. (a) Claims applicable to the period prior (b) Any claim of confidentiality must to commencement of manufacture or im- accompany the information when it is port. (1)(i) A person who submits infor- submitted to EPA. mation to EPA under this part may as- (1)(i) For information submitted on sert a claim of confidentiality for the the notice form, the claim(s) must be chemical identity of the new chemical asserted on the form in the manner substance. This claim will apply only prescribed on the notice form. to the period prior to the commence- (ii) When a person submits informa- ment of manufacture or import for tion in an attachment, the claim(s) commercial purposes. A submitter may must be asserted in the attachment as assert this claim only if the submitter described on the notice form. believes that public disclosure prior to (2) If any information is claimed as commencement of manufacture or im- confidential, the person must submit, port of the fact that anyone intends to in addition to the copies specified by manufacture or import the specific § 720.40, a sanitized copy of the notice chemical substance for commercial form (or electronic submission) and purposes would reveal confidential any attachments. business information. (i) The notice and attachments must (ii) If the notice includes a health be complete. The submitter must des- and safety study concerning the new ignate that information which is chemical substance and if the claim for claimed as confidential in the manner confidentiality with respect to the prescribed on the notice form, via chemical identity is denied in accord- EPA’s e-PMN software. See ance with § 720.90(c), EPA will deny a § 720.40(a)(2)(iv) for information on how claim asserted under this paragraph. to obtain e-PMN software. (2) Any person who asserts a claim of (ii) The sanitized copy must be com- confidentiality for chemical identity plete except that all information under this paragraph must provide one claimed as confidential in the original of the following items at the time the must be deleted. EPA will place this notice is submitted: sanitized copy in the public file. (i) The generic name which was ac- (iii) If the person does not provide cepted by EPA in the prenotice con- the sanitized copy, or information in a sultation conducted under paragraph health and safety study (except infor- (a)(3) of this section. mation claimed as confidential in ac- (ii) One generic name that is only as cordance with § 720.90), the submission generic as necessary to protect the will be deemed incomplete and the no- confidential chemical identity of the tice review period will not begin until particular chemical substance. The EPA receives the sanitized copy or the name should reveal the specific chem- health and safety study information is ical identity to the maximum extent included, in accordance with possible. The generic name will be sub- § 720.65(c)(1)(vii). ject to EPA review and approval at the (c) EPA will disclose information time a notice of commencement is sub- that is subject to a claim of confiden- mitted. tiality asserted under this section only (3)(i) Any person who intends to as- to the extent permitted by the Act, sert a claim of confidentiality for the this subpart, and part 2 of this title. chemical identity of a new chemical (d) If a notice submitter does not as- substance may seek a determination by sert a claim of confidentiality for in- EPA of an appropriate generic name formation at the time it is submitted for the substance before submitting a to EPA, EPA may make the informa- notice. For this purpose, the person tion public and place it in the public should submit to EPA:

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(A) The chemical identity of the sub- ance with § 720.90(c), EPA will deny a stance. claim asserted under this paragraph. (B) A proposed generic name(s) which (3) Any person who asserts a con- in only as generic as necessary to pro- fidentiality claim for chemical identity tect the confidential chemical identity must: of the new chemical substance. The (i) Comply with the requirements of name(s) should reveal the chemical paragraph (a)(3) of this section regard- identity of the substance to the max- ing submission of a generic name. imum extent possible. (ii) Agree that EPA may disclose to a (ii) Within 30 days, EPA will inform person with a bona fide intent to manu- the submitter either that one of the facture or import the chemical sub- proposed generic names is adequate or stance the fact that the particular that none is adequate and further con- chemical substance is included on the sultation is necessary. confidential Inventory for purposes of (4) If a submitter claims chemical notification under section 5(a)(1)(A) of identity to be confidential under this the Act. paragraph, and if the submitter com- (iii) Have available for the particular plies with paragraph (a)(2) of this sec- chemical substance, and agree to fur- tion, EPA will issue for publication in nish to EPA upon request: the FEDERAL REGISTER notice described (A) An elemental analysis. in § 720.70 the generic name proposed by (B) Either an X-ray diffraction pat- the submitter or one agreed upon by tern (for inorganic substances), a mass EPA and the submitter. spectrum (for most other substances), (b) Claims applicable to the period after or an infrared spectrum of the par- commencement of manufacture or import. ticular chemical substance, or if such (1) Any claim of confidentiality under data do not resolve uncertainties with paragraph (a) of this section is applica- respect to the identity of the chemical ble only until the substance is manu- substance, additional or alternative factured or imported for commercial spectra or other data to identify the purposes and becomes eligible for in- chemical substance. clusion on the Inventory. To maintain (iv) Provide a detailed written sub- the confidential status of the chemical stantiation of the claim, by answering identity when the substance is added to the following questions: the Inventory, a submitter must re- (A) What harmful effects to your assert the confidentiality claim and competitive position, if any, do you substantiate the claim in the notice of think would result if EPA publishes on commencement of manufacture re- the Inventory the identity of the chem- quired under § 720.102. A submitter may ical substance? How could a competitor not claim the chemical indentity con- use such information given the fact fidential for the period after com- that the identity of the substance oth- mencement of manufacture or import erwise would appear on the Inventory unless the submitter claimed the of chemical substances with no link be- chemical identity confidential for the tween the substance and your company period prior to commencement of man- or industry? How substantial would the ufacture or import under paragraph (a) harmful effects of disclosure be? What of this section. is the casual relationship between the (2)(i) A person who believes that pub- disclosure and the harmful effects? lic disclosure of the fact that anyone (B) For what period of time should manfactures or imports the new chem- confidential treatment be given? Until ical substance for commercial purposes a specific date, the occurrence of a spe- would reveal confidential business in- cific event, or permanently? Why? formation may assert a claim of con- (C) Has the chemical substance been fidentiality under this paragraph. patented? If so, have you granted li- (ii) If the notice includes a health censes to others with respect to the and safety study concerning the new patent as it applies to the chemical chemical substance, and if the claim substance? If the chemical substance for confidentiality with respect to the has been patented and therefore dis- chemical identity is denied in accord- closed through the patent, why should

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it be treated as confidential for pur- (A) The submitter asserts a claim of poses of the Inventory? confidentiality in accordance with this (D) Has the identity of the chemical paragraph. substance been kept confidential to the (B) No claim for confidentiality of extent that your competitors do not the specific chemical identity as part know it is being manufactured on im- of a health and safety study has been ported for a commercial purpose by denied in accordance with part 2 of this anyone? title or § 720.90. (E) Is the fact that someone is manu- (ii) Publication of a generic name on facturing or importing this chemical the public Inventory does not create a substance for commercial purposes category for purposes of the Inventory. available to the public, e.g., in tech- Any person who has a bona fide intent nical journals or other publications; in to manufacture or import a chemical libraries; or in State, local, or Federal substance which is described by a ge- agency public files? neric name on the public Inventory (F) What measures have you taken to may submit an inquiry to EPA under prevent undesired disclosure of the fact § 720.25(b) to determine whether the that you are manufacturing or import- particular chemical substance is in- ing this substance for a commercial cluded on the confidential Inventory. purpose? (iii) Upon receipt of a request de- (G) To what extent has the fact that scribed in § 720.25(b), EPA may require you are manufacturing or importing the submitter which originally as- this chemical substance for a commer- serted confidentiality for a chemical cial purpose been disclosed to others? substance to submit to EPA the infor- What precautions have you taken in re- mation listed in paragraph (b)(3)(iii) of gard to these disclosures? Has this in- this section. formation been disclosed to the public (iv) Failure to submit any of the in- or to competitors? formation required under paragraph (H) In what form does this particular (b)(3)(iii) of this section within ten chemical substance leave the site of days of a request by EPA under this manufacture, e.g., as part of a product; paragraph is a waiver of the original in an effluent or emission stream? If submitter’s confidentiality claim. In so, what measures have you taken to this event, EPA may place the specific guard against discovery of its identity? chemical identity on the public Inven- tory without further notice to the (I) If the chemical substance leaves original submitter. the site of manufacture in a product (6) If a submitter asserts a claim of that is available to either the public or confidentiality under this paragraph, your competitors, can they identify the EPA will examine the generic chemical substance by analyzing the product? name proposed by the submitter. (J) For what purpose do you manu- (i) If EPA determines that the ge- facture or import the substance? neric name proposed by the submitter (K) Has EPA, another Federal agen- is only as generic as necessary to pro- cy, or any Federal court made any per- tect the confidential identity of the tinent confidentiality determinations particular chemical substance, EPA regarding this chemical substance? If will place that generic name on the so, copies of such determinations must public Inventory. be included in the substantiation. (ii) If EPA determines that the ge- (L) If the notice includes a health neric name proposed by the submitter and safety study concerning the new is more generic than necessary to pro- chemical substance, the submitter tect the confidential identity, EPA will must also answer the questions in propose in writing, for review by the § 720.90(b)(2). submitter, an alternative generic name (4) If the submitter does not meet the that will reveal the chemical identity requirements of this paragraph, EPA of the chemical substance to the max- will deny the claim of confidentiality. imum extent possible. (5)(i) EPA will publish a generic (iii) If the generic name proposed by name on the public Inventory if: EPA is acceptable to the submitter,

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EPA will place that generic name on deny any claim of confidentiality with the public Inventory. respect to information included in a (iv) If the generic name proposed by health and safety study, unless the in- EPA is not acceptable to the sub- formation would disclose confidential mitter, the submitter must explain in business information concerning: detail why disclosure of that generic (1) Processes used in the manufacture name would reveal confidential busi- or processing of a chemical substance ness information and propose another or mixture. generic name which is only as generic (2) In the case of a mixture, the por- as necessary to protect the confidential tion of the mixture comprised by any identity. If EPA does not receive a re- of the chemical substances in the mix- sponse from the submitter within 30 ture. days after the submitter receives the (3) Information which is not in any proposed name, EPA will place EPA’s way related to the effects of a sub- chosen generic name on the public In- stance on human health or the environ- ventory. If the submitter does provide ment, such as the name of the submit- the information requested, EPA will ting company, cost or other financial review the response. If the submitter’s data, product development or mar- proposed generic name is acceptable, keting plans, and advertising plans, for EPA will publish that generic name on which the person submits a claim of the public Inventory. If the submitter’s confidentiality in accordance with proposed generic name is not accept- § 720.80. able, EPA will notify the submitter of (b) Specific chemical identity—(1) EPA’s choice of a generic name. Thirty Claims applicable to period prior to com- days after this notification, EPA will mencement of manufacture. A claim of place the chosen generic name on the confidentiality for the period prior to public Inventory. commencement of manufacture or import for the chemical identity of a § 720.87 Categories or proposed cat- chemical substance for which a health egories of uses of a new chemical and safety study was submitted must substance. be asserted in conjunction with a claim (a) A person who submits informa- asserted under § 720.85(a). tion to EPA under this part on the cat- (2) Claims applicable to period after egories or proposed categories of use of commencement of manufacture or import a new chemical substance may assert a for commercial purposes. To maintain claim of confidentiality for this infor- the confidential status of the chemical mation. identity of a chemical substance for (b) A submitter that asserts such a which a health and safety study was claim must: submitted after commencement of (1) Report the categories or proposed manufacture or import, the claim must categories of use of the chemical sub- be reasserted and substantiated in con- stance. junction with a claim under § 720.85(b). (2) Provide, in nonconfidential form, In addition to the questions set forth a description of the uses that is only as in § 720.85(b)(3)(iv) of this part, the sub- generic as necessary to protect the mitter must answer the following ques- confidential business information. The tions: generic use description will be included (i) Would disclosure of the chemical in the FEDERAL REGISTER notice de- identity disclose processes used in the scribed in § 720.70. manufacture or processing of a chem- (c) The person must submit the infor- ical substance or mixture? Describe mation required by paragraph (b) of how this would occur. In responding to this section in the manner specified in the question in § 720.85(b)(3)(iv)(A), ex- the notice form. plain what harmful competitive effects would occur from disclosure of this § 720.90 Data from health and safety process information. studies. (ii) Would disclosure of the chemical (a) Information other than specific identity disclose the portion of a mix- chemical identity. Except as provided in ture comprised by any of the subparagraph (b) of this section, EPA will stances in the mixture? Describe how

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this would occur. In responding to the 4 p.m. weekdays excluding legal holi- question in § 720.85(b)(3)(iv)(A), explain days. what harmful competitive effects [48 FR 21742, May 13, 1983, as amended at 53 would occur from disclosure of this in- FR 12523, Apr. 15, 1988; 60 FR 16311, Mar. 29, formation. 1995; 60 FR 34464, July 3, 1995] (iii) Do you assert that disclosure of the chemical identity is not necessary Subpart F—Commencement of to interpret any of the health and safe- Manufacture or Import ty studies you have submitted? If so, explain how a less specific identity § 720.102 Notice of commencement of would be sufficient to interpret the manufacture or import. studies. (a) Applicability. Any person who (c) Denial of confidentiality claim. EPA commences the manufacture or import will deny a claim of confidentiality for of a new chemical substance for a non- chemical identity under paragraph (b) exempt commercial purpose for which of this section, unless: that person previously submitted a sec- (1) The information would disclose tion 5(a) notice under this part must processes used in the manufacture or submit a notice of commencement of processing of a chemical substance or manufacture or import. mixture. (b) When to report. (1) If manufacture (2) In the case of a mixture, the infor- or import for commercial purposes begins on or after the effective date of mation would disclose the portion of this rule, the submitter must submit the mixture comprised by any of the the notice to EPA on, or no later than substances in the mixture. 30 calendar days, after the first day of (3) The specific chemical identity is such manufacture or import. not necessary to interpret a health and (2) If manufacture or import for com- safety study. mercial purposes began or will begin (d) Use of generic names. When EPA before the effective date of this rule, discloses a health and safety study con- the submitter must submit the notice taining a specific chemical identity, by the effective date of this rule. which the submitter has claimed con- (c) Information to be reported on form. fidential, and if the Agency has not de- (1) The notice must be submitted on nied the claim under paragraph (c) of EPA Form 7710–56, which is available this section, EPA will identify the as part of EPA’s e-PMN software. See chemical substance by the generic § 720.40(a)(2)(iv) for information on how name selected under § 720.85. to obtain e-PMN software. The form must be signed and dated by an Au- [48 FR 21742, May 13, 1983, as amended at 58 thorized Official (AO). All information FR 34204, June 23, 1993] specified on the form must be provided. § 720.95 Public file. The notice must contain the following information: All information submitted with a no- (i) The specific chemical identity of tice, including any health and safety the PMN substance. study and other supporting documenta- (ii) A generic chemical name (if the tion, will become part of the public file chemical identity is claimed as con- for that notice, unless such materials fidential by the submitter). are claimed confidential. In addition, (iii) The premanufacture notice EPA may add materials to the public (PMN) number assigned by EPA. file, subject to subpart E of this part. (iv) The date of commencement for Any of the nonconfidential material the submitter’s manufacture or import described in this subpart will be avail- for a non-exempt commercial purpose able for public inspection in the Non- (indicating whether the substance was Confidential Information Center initially manufactured in the United (NCIC) (7407), Office of Pollution Pre- States or imported). The date of com- vention and Toxics, U.S. Environ- mencement is the date of completion of mental Protection Agency, Room B–607 non-exempt manufacture of the first NEM, 401 M St., SW., Washington, DC amount (batch, drum, etc.) of new 20460, between the hours of 12 p.m. and chemical substance identified in the

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submitter’s PMN. For importers, the mencement must be generated using e- date of commencement is the date the PMN reporting software and be com- new chemical substance clears United pleted through the finalization step of States customs. the software, and e-PMN software must (v) The name and address of the sub- be used to print the notice of com- mitter. mencement for submission to EPA. (vi) The name of the authorized offi- Paper notices of commencement must cial. be submitted either via U.S. mail to (vii) The name and telephone number the Document Control Office (DCO) of a technical contact in the United (7407M), Office of Pollution Prevention States. and Toxics, Environmental Protection (viii) The address of the site where Agency, 1200 Pennsylvania Ave., NW., commencement of manufacture oc- Washington, DC 20460–0001 or submitted curred. via courier to the Environmental Pro- (ix) Clear indications of whether the tection Agency, OPPT Document Con- chemical identity, submitter identity, trol Office (DCO), EPA East Bldg., 1201 and/or other information are claimed Constitution Ave., NW., Rm. 6428, as confidential by the submitter. Washington, DC 20004. (2) If the submitter claims the chem- (ii) Notices of commencement may be ical identity confidential, and wants submitted as electronic files on optical the identity to be listed on the con- disc on or before April 6, 2012. All no- fidential portion of the Inventory, the tices of commencement submitted as claim must be reasserted and substan- electronic files on optical disc must be tiated in accordance with § 720.85(b). generated using e-PMN reporting soft- Otherwise, EPA will list the specific ware and be completed through the fi- chemical identity on the public Inven- nalization step of the software. Optical tory. Submitters who did not claim the discs containing electronic notices of chemical identity, submitter identity, commencement must be submitted by or other information to be confidential courier to the Environmental Protec- in the PMN cannot claim this information Agency, OPPT Document Control tion as confidential in the notice of Office (DCO), EPA East Bldg., 1201 Con- commencement. stitution Ave., NW., Rm. 6428, Wash- (d) Where to submit. All notices of ington, DC 20004. commencement must be submitted to (iii) Notices of commencement may EPA on EPA Form 7710–56. Notices be submitted electronically to EPA via may only be submitted in a manner set CDX on or after April 6, 2010. After forth in this paragraph. April 6, 2012 all notices of commence- (1) Older notices. Notices of comment must be submitted electronically mencement for premanufacture notices to EPA via CDX. Prior to submission submitted before April 6, 2010 must be to EPA via CDX, such notices of com- submitted on paper either via U.S. mail mencement must be generated and to the Document Control Office (DCO) completed using e-PMN reporting soft- (7407M), Office of Pollution Prevention ware. See § 720.40(a)(2)(iv) for informa- and Toxics, Environmental Protection tion on how to obtain e-PMN software. Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001 or submitted [48 FR 21742, May 13, 1983, as amended at 48 via courier to the Environmental Pro- FR 41140, Sept. 13, 1983; 51 FR 15103, Apr. 22, tection Agency, OPPT Document Con- 1986; 53 FR 12523, Apr. 15, 1988; 60 FR 16311, Mar. 29, 1995; 60 FR 34464, July 3, 1995; 65 FR trol Office (DCO), EPA East Bldg., 1201 39304, June 26, 2000; 71 FR 33641, June 12, 2006; Constitution Ave., NW., Rm. 6428, 75 FR 786, Jan. 6, 2010] Washington, DC 20004. (2) Newer notices. For premanufacture notices submitted on or after April 6, Subpart G—Compliance and 2010, EPA will accept notices of com- Inspections mencement only if submitted in accordance with this paragraph: § 720.120 Compliance. (i) Notices of commencement may be (a) Failure to comply with any provi- submitted on paper on or before April sion of this part is a violation of sec- 6, 2011. All paper-based notices of com- tion 15 of the Act (15 U.S.C 2614).

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(b) A person who manufactures or im- 721.11 Applicability determination when the ports a new chemical substance before specific chemical identity is confidential. a notice is submitted and the notice re- 721.20 Exports and imports. view period expires is in violation of 721.25 Notice requirements and procedures. 721.30 EPA approval of alternative control section 15 of the Act even if that per- measures. son was not requied to submit the no- 721.35 Compliance and enforcement. tice under § 720.22. 721.40 Recordkeeping. (c) Using for commercial purposes a 721.45 Exemptions. chemical substance or mixture which a 721.47 Conditions for research and develop- person knew or had reason to know was ment exemption. manufactured, processed, or distributed in commerce in violation of sec- Subpart B—Certain Significant New Uses tion 5 of this rule is a violation of sec- 721.50 Applicability. tion 15 of the Act (15 U.S.C. 2614). 721.63 Protection in the workplace. (d) Failure or refusal to establish and 721.72 Hazard communication program. maintain records or to permit access to 721.80 Industrial, commercial, and consumer or copying of records, as required by activities. the Act, is a violation of section 15 of 721.85 Disposal. 721.90 Release to water. the Act (15 U.S.C. 2614). 721.91 Computation of estimated surface (e) Failure or refusal to permit entry water concentrations: Instructions. or inspection as required by section 11 is a violation of section 15 of the Act Subpart C—Recordkeeping Requirements (15 U.S.C. 2614). (f) Violators may be subject to the 721.100 Applicability. civil and criminal penalties in section 721.125 Recordkeeping requirements. 16 of the Act (15 U.S.C. 2615) for each Subpart D—Expedited Process for Issuing violation. Persons who submit materi- Significant New Use Rules for Selected ally misleading or false information in Chemical Substances and Limitation connection with the requirements of or Revocation of Selected Significant any provision of this rule may be sub- New Use Rules ject to penalties calculated as if they never filed their notices. 721.160 Notification requirements for new (g) EPA may seek to enjoin the man- chemical substances subject to section ufacture or processing of a chemical 5(e) orders. substance in violation of this rule or 721.170 Notification requirements for se- act to seize any chemical substance lected new chemical substances that have completed premanufacture review. manufactured or processed in violation 721.185 Limitation or revocation of certain of this rule or take other actions under notification requirements. the authority of section 7 of this Act (15 U.S.C. 2606) or section 17 or this Act Subpart E—Significant New Uses for (15 U.S.C. 2616). Specific Chemical Substances § 720.122 Inspections. 721.225 2-Chloro-N-methyl-N-substituted acetamide (generic name). EPA will conduct inspections under 721.267 N-[2-[(substituted section 11 of the Act to assure compli- dinitrophenyl)azo]diallylamino-4-sub- ance with section 5 of the Act and this stituted phenyl] acetamide (generic rule, to verify that information sub- name). mitted to EPA under this rule is true 721.275 Halogenated-N-(2-propenyl)-N-(sub- and correct, and to audit data substituted phenyl) acetamide. mitted to EPA under this rule. 721.285 Acetamide, N-[4-(pentyloxy)phenyl]-, acetamide, N-[2-nitro-4- (pentyloxy)phenyl]-, and acetamide, N-[2- PART 721—SIGNIFICANT NEW USES amino-4-(pentyloxy)phenyl]-. OF CHEMICAL SUBSTANCES 721.303 Substituted acetate (generic). 721.304 Acetic acid, [(5-chloro-8-quino- Subpart A—General Provisions linyl)oxy-], 1-methyl hexyl ester. 721.305 Di-substituted acetophenone (ge- Sec. neric). 721.1 Scope and applicability. 721.320 Acrylamide-substituted epoxy. 721.3 Definitions. 721.321 Substituted acrylamides and acrylic 721.5 Persons who must report. acid copolymer (generic).

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721.323 Substituted acrylamide. 721.638 Silyl amine, potassium salt (ge- 721.324 Alkoxylated acrylate polymer (generic). neric). 721.639 Amine aldehyde condensate. 721.329 Halogenated benzyl ester acrylate 721.640 Amine substituted metal salts. (generic). 721.641 Alkylpoly(oxyalkylene)amine. 721.330 Aromatic acrylate (generic). 721.642 Amines, N-(C14–18 and C16–18 unsatu- 721.333 Dimethyl alkylamine salt (generic). rated alkyl)] dipropylene-tri-, 721.336 Perfluoroalkylethyl acrylate copoly- tripropylenetetra-, and mer (generic name). tetrapropylenepenta-. 721.338 Salt of an acrylate copolymer (ge- 721.643 Ethoxylated alcohol, phosphated, neric). amine salt. 721.405 Polyether acrylate. 721.644 Amines, C12-14-tert-alkyl, sulfonates. 721.430 Oxo-substituted aminoalkanoic acid 721.646 Aminofluoran derivative (generic derivative. name). 721.435 Alkylphenylpolyetheralkanolamines 721.647 Alkoxylated alkyl amine (generic). (generic). 721.648 Alkyl dialkylamino phenylsulfonyl 721.445 Substituted ethyl alkenamide. alkenoate (generic). 721.450 Hydrofluorochloroalkene (generic). 721.650 11-Aminoundecanoic acid. 721.463 Acrylate of polymer based on 721.655 Ethoxylated alkyl quaternary am- isophorone diisocyanate (generic). monium compound. 721.465 Alkoxylated alkylpolyol acrylates, 721.715 Trisubstituted anthracene. adduct with alkylamine (generic). 721.720 Alkoxylated fatty acid amide, 721.480 Aminoester of polyalkenylated alkylsulfate salt. alkyldicarboxylic acid (generic). 721.750 Aromatic amine compound. 721.484 Fluorinated acrylic copolymer (ge- 721.757 Polyoxyalkylene substituted aro- neric name). matic azo colorant. 721.505 Halogenated acrylonitrile. 721.775 Brominated aromatic compound (ge- 721.520 Alanine, N-(2-carboxyethyl)-N- neric name). alkyl-, salt. 721.785 Halogenated alkane aromatic com- 721.522 Oxirane, methyl-, polymer with pound (generic name). oxirane, mono(3,5,5,-trimethylhexyl) ′ ether. 721.805 Benzenamine, 4,4 -[1,3-phenylenebis(1-methylethyl idene)]bis[2,6-di- 721.524 Alcohols, C6-12, ethoxylated, reaction product with maleic anhydride. methyl-. 721.525 1-propanol, 3-propoxy-. 721.825 Certain aromatic ether diamines. 721.530 Substituted aliphatic acid halide 721.840 Alkyl substituted diaromatic hydro- (generic name). carbons. 721.532 Substituted hydroxyalkane acetate 721.843 Substituted phenylazophenylazo (generic). phenol (generic). 721.533 Propane, 1,1,1,3,3-pentachloro-. 721.875 Aromatic nitro compound. 721.535 Halogenated alkane (generic). 721.910 Propanetriol 721.536 Halogenated phenyl alkane. polyalkylenepolyolamine aryl aldimine 721.537 Organosilane ester. (generic). 721.538 Phenol, 4-(1,1-dimethylethyl)-, 721.925 Substituted aromatic (generic). homopolymer. 721.950 Sodium salt of an alkylated, sulfo- 721.539 Poly(oxy-1,2-ethanediyl), a-sulfo-w- nated aromatic (generic name). [1-[(4-nonylphenoxy)methyl]-2-(2- 721.977 Aryloxyarene. propenyloxy)ethoxy]-, branched, ammo- 721.980 Sodium salt of azo acid dye. nium salts. 721.981 Substituted naphtholoazo-sub- 721.540 Alkylphenoxypolyalkoxyamine (ge- stituted naphthalenyl-substituted neric name). azonaphthol chromium complex. 721.545 Polyalkenylalkylphenol (generic). 721.982 Calcium, bis(2,4-pentanedionato- 721.550 Alkyl alkenoate, azobis-. O,O′). 721.555 Alkyl amino nitriles (generic). 721.983 Sulfonyl azide intermediate (ge- 721.558 Salt of a fatty alkylamine derivative neric). (generic). 721.984 Amino-hydroxy sulfonaphthylazo- 721.562 Substituted alkylamine salt. disubstituted phenyl azo benzene 721.575 Substituted alkyl halide. carboxylate salt (generic). 721.600 3-Alkyl-2-(2-anilino)vinyl thiazolini- 721.987 Dialkylaminophenyl imino pyrazole um salt (generic name). acid ester (generic). 721.625 Alkylated diarylamine, sulfurized 721.988 Pyrazolone azomethine dye (ge- (generic name). neric). 721.630 Salt of a modified tallow 721.990 1,4-Benzedicarboxylic acid, dimethyl alkylenediamine (generic). ester, polymer with 1,4-butanediol, 721.632 Silicoaluminophosphates, compd. cyclized. with organic amine (generic). 721.1000 Benzenamine, 3-chloro-2,6-dinitro- 721.633 Aluminosilicates, phospho-. N,N-dipropyl-4-(trifluoromethyl)-.

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721.1025 Benzenamine, 4-chloro-2-methyl-; 721.1579 1,2,4-Benzenetricarboxylic acid, tris benzenamine, 4-chloro-2-methyl-, hydro- [4-(ethenyloxy) butyl] ester. chloride; and benzenamine, 2-chloro-6- 721.1580 Disubstituted benzene ether, poly- methyl-. mer with substituted phenol (generic). 721.1050 Benzenamine, 2,5-dibutoxy-4-(4- 721.1612 Substituted 2-nitro- and 2- morpholinyl)-, sulfate. aminobenzesulfonamide. 721.1055 Benzeneamine, 3,5-difluoro-. 721.1620 Benzenesulfonamide, alkylphenyl 721.1068 Benzenamine, 4-isocyanato-N,N- substituted phenyl substituted carbonyl- bis(4-isocyanatophenyl)-2,5-dimethoxy-. (generic). 721.1070 Benzenamine, 4-methoxy-2-methyl- 721.1625 Alkylbenzene sulfonate, amine salt. N-(3-methylphenyl). 721.1630 1,2-Ethanediol bis(4- 721.1075 Benzenamine, 4-(1-methylbutoxy)-, methylbenzenesulfonate); 2,2-oxybis-eth- hydrochloride. ane bis(4-methylbenzenesulfonate); eth- 721.1085 Benzenamine,4,4′-methylenebis[N- anol, 2,2′-[oxybis(2,1-ethanediyl oxy)]bis-, ethyl-N-methyl-. bis(4-methylbenzenesulfonate); ethanol, 721.1105 Benzenamine, 4,4′-methylenebis[2- 2,2′-[oxybis (2,1-ethane diyloxy)] bis-, methyl-6-(1-methylethyl)]-. bis(4-methylbenzenesulfonate); ethanol, 721.1120 Benzenamine, 4,4′-[1,4-phenylene- 2,2′-[[1-[(2-propenyloxy) methyl]-1,2- bis(1-methylethylidene)]bis[2,6- di- ethanediyl] bis(oxy)]bis-, bis(4- methyl-. methylbenzene sulfonate); and ethanol, 721.1150 Substituted polyglycidyl benzena- 2-[1-[[2-[2-[[(4-methylphenyl)sulfonyl] mine. oxy]ethoxy] ethoxy]methyl]-2-(2- 721.1155 1,4-benzenediol, 2-(1,1,3,3- propenyloxy)ethoxy]-, 4- tetramethylbutyl)-and methylbenzenesulfonate. Bis(dimethylamino sub- 721.1637 1,2-Propanediol, 3-(2-propenyloxy)-, stituted)carbomonocycle. bis(4-methylbenzene sulfonate); 2-pro- 721.1187 Bis(imidoethylene) benzene. panol, 1-[2-[[(4-methylphenyl)sulfonyl] 721.1193 Benzene, 2-bromo-1,4-dimethoxy-. oxy]ethoxy]-3-(2-propenyloxy)-4- 721.1210 Benzene, (2-chloroethoxy)-. methylbenzenesulfonate; and 2-propanol, 721.1225 Benzene, 1,2-dimethyl-, polypropene 1-[2-[2-[[(4-methylphenyl)sulfonyl]oxy] derivatives, sulfonated, potassium salts. ethoxy]ethoxy]-3-(2-propenyloxy)-, 4- 721.1230 Benzene, ethenyl-, ar-bromo deriva- methylbenzenesulfonate. tives. 721.1640 3,6,9,12,-Tetraoxatetradecane-1,14- 721.1240 Benzene, (2-bromoethyl)-, ar-bromo diol, bis(4-methylbenzenesulfonate; derivatives. 3,6,9,13-tetraoxahexadec-15-ene-1,11-diol, 721.1300 [(Dinitrophenyl)azo]-[2,4-diamino-5- bis(4-methylbenzenesulfonate); 3,6,9,12,16- methoxybenzene] derivatives. pentaoxanonadec-18-ene-1,14-diol, bis(4- 721.1325 Benzene, 1-(1-methylbutoxy)-4- methyl benzenesulfonate); and 3,6,9,12- nitro-. tetraoxatetradecane-1,14-diol, 7-[(2- 721.1350 Benzene, (1-methylethyl)(2- propenyloxy)methyl]-, bis(4- phenylethyl)-. methylbenzenesulfonate). 721.1372 Substituted nitrobenzene. 721.1643 Benzenesulfonic acid, amino sub- 721.1375 Disubstituted nitrobenzene (generic stituted phenylazo-. name). 721.1645 Benzenesulfonic acid, 4-methyl-, re- 721.1425 Pentabromoethylbenzene. action products with oxirane 721.1430 Pentachlorobenzene. mono[(C10-16-alkyloxy)methyl] deriva- 721.1435 1,2,4,5-Tetrachlorobenzene. tives and 2,2,4(or 2,4,4)-trimethyl-1,6– 721.1440 1,3,5-Trinitrobenzene. hexanediamine. 721.1450 1,3-Benzenediamine, 4-(1,1-di- 721.1648 Substituted benzenesulfonic acid methylethyl)-ar-methyl. salt (generic). 721.1500 1,2-Benzenediamine, 4-ethoxy, sul- 721.1650 Alkylbenzenesulfonic acid and so- fate. dium salts. 721.1550 Benzenediazonium, 4-(dimethyl- 721.1655 Alkylbenzenesulfonic acid (ge- amino)-, salt with 2-hydroxy-5-sulfo- neric). benzoic acid (1:1). 721.1660 Benzidine-based chemical sub- 721.1555 Substituted phenyl azo substituted stances. benzenediazonium salt. 721.1675 Disulfonic acid rosin amine salt of a 721.1568 Substituted benzenediazonium. benzidine derivative (generic name). 721.1576 1,3-Benzenedicarboxylic acid, bis[[4- 721.1680 Substituted benzoic acid (generic). [(ethenyloxy)methyl] cyclohexyl] meth- 721.1700 Halonitrobenzoic acid, substituted yl] ester. (generic name). 721.1577 1,4-Benzenedicarboxylic acid, bis [4- 721.1705 Benzoic acid, 3-amino-, diazotized, (ethenyloxy) butyl] ester. coupled with 6-amino-4-hydroxy-2- 721.1578 1,4-Benzenedicarboxylic acid, bis[[4- naphthalenesulfonic acid, diazotized, (3- [(ethenyloxy)methyl] cyclohexyl] meth- aminophenyl)phosphonic acid and yl] ester. diazotized 2,5-diethoxybenzenamine.

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721.1725 Benzoic acid, 3,3′-methylenebis [6 721.2076 D-Glucuronic acid, polymer with 6- amino-, di-2-propenyl ester. deoxy-L-mannose and D-glucose, acetate, 721.1728 Benzoic acid, 2-(3- calcium magnesium potassium sodium phenylbutylidene)amino-, methyl ester. salt. 721.1729 Boric acid (H3BO3), mixed esters 721.2077 Substituted carbazate (generic). with polyethylene glycol mono-Bu ether 721.2078 1-Piperidinecarboxylic acid, 2- and polyethylene glycol mono Me ether. [(dichloro-hydroxy- 721.1730 Poly(oxy-1,2-ethanediyl), a-butyl-w- carbomonocycle)hydrazono]-, methyl hydroxy, ester with boric acid (H3BO3). ester (generic). 721.1731 Poly(oxy-1,2-ethanediyl), a-methyl- 721.2079 Dichloro, hydroxy, hydrazino- w-hydroxy, ester with boric acid (H3BO3). carbomonocycle (generic). 721.1732 Nitrobenzoic acid octyl ester. 721.2081 Dichloro, hydroxy, hydrazino- 721.1734 Substituted benzonitrile (generic). carbomonocycle-monohydrochloride (ge- 721.1735 Alkylbisoxyalkyl (substituted-1,1- neric). dimethylethylphenyl) benzotriazole (ge- 721.2083 Polysubstituted carbomonocyclic neric name). hydroxylamine (generic). 721.1738 Substituted benzotriazole (generic 721.2084 Carbon oxyfluoride (Carbonic name). difluoride). 721.1745 Ethoxybenzothiazole disulfide. 721.2085 Hydroxyalkylquinoline 721.1747 Substituted benzophenone (ge- dioxoindandialkylcarboxamide. neric). 721.2086 Coco acid triamine condensate, 721.1750 1H-Benzotriazole, 5-(pentyloxy)- polycarboxylic acid salts. and 1H-benzotriazole, 5-(pentyloxy)-, so- 721.2087 3-furancarboxaldehyde, tetrahydro-. dium and potassium salts. 721.2088 Carboxylic acids, (C6–C9) branched 721.1755 Methylenebisbenzotriazole. and linear. 721.1760 Substituted benzotriazole deriva- 721.2089 Tetrasubstituted aminocarboxylic tives. acid. 721.1765 2-Substituted benzotriazole. 721.2091 Chloroalkane. 721.1767 Substituted 6,6′-(1- 721.2092 3-Methylcholanthrene. methylethylidene)bis[3,4-dihydro-3- 721.2093 Alkenyl carboxylate, metal salt phenyl-1,3-benzoxazine] (generic). (generic). 721.1775 6-Nitro-2(3H)-benzoxazolone. 721.2094 N,N′-di(alkyl 721.1790 Polybrominated biphenyls. heteromonocycle)amino chlorotriazine. 721.1800 3,3′,5,5′-Tetramethylbiphenyl-4,4′- 721.2095 Chromate(3), bis 2-[[substituted-3- diol. [(5-sulfo-1- 721.1805 Substituted bisaniline. napthalenyl)azo]phenyl]azo]substituted 721.1820 Bisphenol derivative. monocycle, trisodium (generic name). 721.1825 Bisphenol A, epichlorohydrin, poly- 721.2097 Azo chromium complex dyestuff alkylenepolyol and polyisocyanato deriv- preparation (generic name). ative. 721.2098 Aliphatic polycarboxylic acid metal 721.1850 Toluene sulfonamide bisphenol A salt (generic). epoxy adduct. 721.2120 Cyclic amide. 721.1852 Di-alkyl borane (generic). 721.2121 Thiosubstituted carbonate ester 721.1875 Boric acid, alkyl and substituted (generic). alkyl esters (generic name). 721.2122 Substituted phenyl azo substituted 721.1878 Alkali metal alkyl borohydride (ge- sulfo carbopolycycle. neric). 721.2140 Carbopolycyclicol azoalkylaminoal- 721.1880 Borate(1-), tris(acetato- kylcarbomonocyclic ester, halogen acid .kappa.O)hydro-, sodium, (T-4)-. salt. 721.1900 Substituted bromothiophene. 721.2145 Ceteareth-25 sorbate. 721.1907 Butanamide, 2,2′-[3′dichloro[1,1′- 721.2155 Alkoxyamino-alkyl-coumarin (ge- biphenyl]-4,4′-diyl)bisazobis N-2,3- neric). dihydro-2-oxo-1H-benximdazol-5-yl)-3- 721.2175 Salt of cyclodiamine and mineral oxo-. acid. 721.1920 1,4-Bis(3–hydroxy-4- 721.2222 Cyclohexanamine, N,N-dimethyl-, benzoylphenoxy)butane. compd. with alpha-isotridecyl-omega- 721.1925 Substituted carboheterocyclic bu- hydroxypoly(oxy-1,2-ethanediyl) phos- tane tetracarboxylate (generic). phate. 721.1930 Butanoic acid, antimony (3=) salt. 721.2250 1,4-Cyclohexanediamine, cis- and 721.1950 2-Butenedioic acid (Z), mono(2-((1- trans-. oxopropenyloxy)ethyl) ester. 721.2260 1,2-Cyclohexanedicarboxylic acid, 721.2025 Substituted phenylimino carbamate 2,2-bis[[[[2-[(oxiranylmethoxy) car- derivative. bonyl]cyclohexy]carbonyl]oxy]methyl]- 721.2060 Disubstituted benzenedicarboxylic 1,3-propanediyl bis(oxiranylmethyl) acid (generic). ester. 721.2075 Carbamodithioic acid, methyl-, 721.2265 Polyalkylene oxide dialkylamine compound with methanamine (1:1). (generic).

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721.2270 Aliphatic dicarboxylic acid salt. 721.2900 Substituted aminobenzoic acid 721.2275 N,N,N′,N′-Tetrakis(oxiranyl meth- ester (generic name). yl)-1,3-cyclohexane dimethanamine. 721.2920 tert-Amyl peroxy alkylene ester (ge- 721.2280 Cyclopropanecarboxaldehyde. neric name). 721.2287 DDT 721.2925 Brominated aromatic ester. (Dichlorodiphenyltrichloroethane). 721.2950 Carboxylic acid glycidyl esters. 721.2340 Dialkenylamide (generic name). 721.3000 Dicarboxylic acid monoester. 721.2345 Alkyletherpropyl dialkylamines. 721.3020 1,1-Dimethylpropyl peroxyester (ge- 721.2350 Alkyltri, tetra, and pentaamines. neric name). 721.2355 Diethylstilbestrol. 721.3025 Fatty acids C12-18, C18 unsaturated, 721.2380 Disubstituted diamino anisole. C12-18 alkyl esters (generic). 721.2385 Fluoroalkyl diester (generic). 721.3031 Boric acid (H3BO3), zinc salt (2=3). 721.2410 Alkoxylated 721.3032 Boric acid (H3BO2), zinc salt. alkyldiethylenetriamine, alkyl sulfate 721.3034 Methylamine esters. salts. 721.3062 Haloarylalkylketoester (generic). 721.2420 Alkoxylated dialkyldiethylenetria- 721.3063 Substituted phenyl azo substituted mine, alkyl sulfate salt. phenyl esters (generic name). 721.2465 Xanthylium, 9-(2- 721.3080 Substituted phosphate ester (ge- (ethoxycarbonyl)phenyl)-3,6- neric). bis(ethylamino)-2,7-dimethyl-, ethyl sul- 721.3085 Brominated phthalate ester. fate. 721.3100 Oligomeric silicic acid ester com- 721.2475 Dimetridazole. pound with a hydroxylalkylamine. 721.2480 Isoalkyldimethylamine (generic). 721.3110 Polycarboxylic acid ester (generic). 721.2485 1,3-Dioxolane, 2-ethenyl-. 721.3130 Sulfuric acid, mono-C9–11-alkyl 721.2520 Alkylated diphenyls. esters, sodium salts. 721.2527 Substituted diphenylazo dye (ge- 721.3135 Phosphorous modified epoxy resin neric name). (generic). 721.2532 Substituted diphenylmethane (ge- 721.3140 Vinyl epoxy ester. neric). 721.3152 Ethanaminium, N-ethyl-2-hydroxy- 721.2535 Benzene, 1,1′-methylanebis[4- N,N-bis(2-hydroxyethyl)-, diester with isocyanato-, homopolymer, Bu alc.- C12-18 fatty acids, ethyl sulfates (salts). blocked. 721.3155 3,8-Dioxa-4,7-disiladecane, 4,4,7,7- 721.2540 Diphenylmethane diisocyanate tetraethoxy-. (MDI) modified. 721.3160 1-Chloro-2-bromoethane. 721.2560 Alkylated diphenyl oxide (generic 721.3220 Pentachloroethane. name). 721.3248 Ethane, 1,2,2-trichlorodifluoro-. 721.2565 Alkylated sulfonated diphenyl 721.3260 Ethanediimidic acids. oxide, alkali and amine salts. 721.3310 Poly[oxy(methyl-1,2-ethanediyl)],a- 721.2570 Alkylated diphenyls (generic). (1-oxo-2-propenyl)-w-[(tetrahydro-2- 721.2575 Disubstituted diphenylsulfone. furanyl)methoxy]-. 721.2577 Copper complex of (substituted 721.3320 Ethanol, 2-amino-, compound with sulfonaphthyl azo substituted phenyl) N-hydroxy-N-nitrosobenzenamine (1:1). disulfonaphthyl azo, amine salt (ge- 721.3340 Ethanol, 2,2′-(hexylamino)bis-. neric). 721.3350 N-Nitrosodiethanolamine. 721.2580 C.I. Disperse Red 152 (generic). 721.3360 Substituted ethanolamine. 721.2582 Reaction product of alkylene 721.3364 Aliphatic ether. diamine, MDI, substituted 721.3374 Alkylenediolalkyl ether. carbomonocyclic amine and alkylamine 721.3380 Anilino ether. (generic). 721.3420 Brominated arylalkyl ether. 721.2584 Dodecanoic acid, 12-amino-. 721.3430 4-Bromophenyl phenyl ether. 721.2585 Sodium salts of dodecylphenol (ge- 721.3435 Butoxy-substituted ether alkane. neric). 721.3437 Dialkyl ether. 721.2600 Epibromohydrin. 721.3438 Chlorohydroxyalkyl butyl ether 721.2625 Reaction product of alkanediol and (generic). epichlorohydrin. 721.3440 Haloalkyl substituted cyclic ethers. 721.2673 Aromatic epoxide resin (generic). 721.3465 Stilbene diglycidyl ether. 721.2675 Perfluoroalkyl epoxide (generic 721.3480 Halogenated biphenyl glycidyl name). ethers. 721.2685 Polyisobutene epoxide (generic). 721.3485 Hydrofluorocarbon alkyl ether. 721.2725 Trichlorobutylene oxide. 721.3486 Polyglycerin mono(4-nonylphenyl) 721.2752 Epoxy resin containing phosphorus ether. (generic). 721.3488 Poly(oxy-1,2-ethanediyl), alpha sub- 721.2755 Cycloaliphatic epoxy resin (ge- stituted-omega-hydroxy-, C16-20 alkyl neric). ethers. 721.2800 Erionite fiber. 721.3500 Perhalo alkoxy ether. 721.2805 Acrylate ester. 721.3520 Aliphatic polyglycidyl ether. 721.2825 Alkyl ester (generic name). 721.3550 Dipropylene glycol dimethyl ether.

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721.3560 Derivative of tetrachloroethylene. 721.4060 Alkylene glycol terephthalate and 721.3565 Ethylenediamine, substituted, so- substituted benzoate esters (generic dium salt. name). 721.3620 Fatty acid amine condensate, 721.4080 MNNG (N-methyl-N′-nitro-N- polycarboxylic acid salts. nitrosoguanidine). 721.3625 Fatty acid amine salt (generic 721.4085 Guanidine, pentaethyl-. name). 721.4090 Ethanaminium, N- 721.3627 Branched synthetic fatty acid. [bis(diethylamino)-methylene]-N-ethyl-, 721.3629 Triethanolamine salts of fatty bromide. acids. 721.4095 Quaternary ammonium 721.3635 Octadecanoic acid, ester with 1,2- alkyltherpropyl trialkylamine halides. propanediol, phosphate, anhydride with 721.4096 Substituted anilino halobenzamide silicic acid (H4SiO4). (generic). 721.3680 Ethylene oxide adduct of fatty acid 721.4097 7-Oxabicyclo[4.1.0]heptane-3-car- ester with pentaerythritol. boxylic acid, methyl ester. 721.3700 Fatty acid, ester with styrenated 721.4098 Substituted heteroaromatic-2[[4- phenol, ethylene oxide adduct. (dimethylamino) phenyl]azo]-3-methyl-, 721.3710 Polyether modified fatty acids (ge- salts (generic). neric). 721.4100 Tris(disubstituted alkyl) heterocy- 721.3720 Fatty amide. cle. 721.3740 Bisalkylated fatty alkyl amine 721.4105 Bicyclo[2.2.1]hept-2-ene, 5-butyl-. oxide 721.4106 Bicyclo[2.2.1]hept-2-ene, 5-hexyl-. 721.3760 Fluorene-containing diaromatic 721.4107 Bicyclo[2.2.1]hept-2-ene, 5-octyl-. amines. 721.4108 Bicyclo[2.2.1]hept-2-ene, 5-decyl-. 721.3764 Fluorene substituted aromatic 721.4110 Allyloxysubstituted heterocycle. amine. 721.4128 Dimethyl-3-substituted heteromon- 721.3780 Substituted and disubstituted ocycle. tetrafluoro alkenes (generic). 721.3790 Polyfluorocarboxylates. 721.4133 Dimethyl-3-substituted 721.3800 Formaldehyde, condensated polyox- heteromonocyclic amine. yethylene fatty acid, ester with 721.4136 Alkyl heteropolycyclic-aniline (ge- styrenated phenol, ethylene oxide neric). adduct. 721.4140 Hexachloronorbornadiene. 721.3805 Formaldehyde, reaction products 721.4155 Hexachloropropene. with 1,3-benzenedimethanamine and 721.4158 Hexadecanoic acid, ethenyl ester. bisphenol A. 721.4160 Hexafluoropropylene oxide. 721.3807 Formaldehyde, polymer with phe- 721.4180 Hexamethylphosphoramide. nol and 1,2,3-propanetriol, methylated. 721.4215 Hexanedioic acid, diethenyl ester. 721.3810 Formaldehyde, polymers with sub- 721.4250 Hexanoic acid, 2-ethyl-, ethenyl stituted phenols (generic). ester. 721.3812 Substituted phenols and formalde- 721.4255 1,4,7,10,13,16- hyde polymer, alkylated (generic). Hexaoxacyclooctadecane, 2-[(2-propenyl 721.3815 Furan, 2-(ethoxymethyl)- oxy)methyl]-. tetrahydro-. 721.4257 Hydrazine, (2-fluorophenyl). 721.3818 Furan, octafluorotetrahydro-. 721.4258 Substituted naphthalene hydrazide 721.3820 L-Glutamic acid, N-(1-oxododecyl)-, (generic). disodium salt. 721.4259 Aliphatic polyisocyanate 721.3821 L-Gutamic acid, N-(1-oxododecyl)-. homopolymer. 721.3830 Formaldehyde, reaction products 721.4260 Hydrazine, [4-(1-methylbu- with an alkylated phenol and an ali- toxy)phenyl]-, monohydrochloride. phatic amine (generic). 721.4265 Hydrazinecarboxamide, N-(3,5- 721.3835 Chloroformate (generic). difluorophenyl-). 721.3840 Tetraglycidalamines (generic 721.4270 Nitrophenoxylalkanoic acid sub- name). stituted thiazino hydrazide (generic 721.3845 Alkyl substituted aromatic glycidyl name). ether (generic). 721.4280 Substituted hydrazine. 721.3848 Glycine, N-(carboxymethyl)-N- 721.4300 Hydrazinecarboxamide, N,N′-1,6- dodecyl-, monosodium salt. hexanediylbis [2,2-dimethyl-]. 721.3860 Glycol monobenzoate. 721.4320 Hydrazinecarboxamide, N,N′-(meth- 721.3880 Polyalkylene glycol substituted ac- ylenedi-4,1-phenylene)bis [2,2-dimethyl-. etate. 721.4340 Substituted thiazino hydrazine salt 721.3900 Alkyl polyethylene glycol phos- (generic name). phate, potassium salt. 721.4360 Certain hydrogen containing chlor- 721.4000 Polyoxy alkylene glycol amine. ofluorocarbons. 721.4040 Glycols, polyethylene-, 3-sulfo-2-hy- 721.4365 Substituted ethoxylated hydro- droxypropyl-p-(1,1,3,3-tetra- carbon (generic). methylbutyl)phenyl ether, sodium salt. 721.4380 Modified hydrocarbon resin.

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721.4385 Hydrofluoric acid, reaction prod- 721.4680 Metal salts of complex inorganic ucts with heptane. oxyacids (generic name). 721.4390 Trisubstituted hydroquinone 721.4685 Substituted purine metal salt (ge- diester. neric name). 721.4420 Substituted hydroxylamine. 721.4700 Metalated alkylphenol copolymer 721.4460 Amidinothiopropionic acid hydro- (generic name). chloride. 721.4720 Disubstituted phenoxazine, chloro- 721.4461 Hydrofluoric acid, reaction prod- metalate salt. ucts with octane (generic). 721.4740 Alkali metal nitrites. 721.4462 Hydrochlorofluorocarbon. 721.4792 2-Propenoic acid, 2-methyl-, C11-14- 721.4463 Hydrochlorofluorocarbon. isoalkyl esters, C13-rich. 721.4464 Mixture of hydrofluoro alkanes and 721.4794 Polypiperidinol-acrylate methacry- hydrofluoro alkene. late. 721.4465 Hydrofluoroalkane. 721.4820 Methane, bromodifluoro-. 721.4467 Quaternary ammonium hydroxide. 721.4840 Substituted triphenylmethane. 721.4468 1H-Imidazole, 2-ethyl-4,5-dihydro-4- 721.4880 Methanol, trichloro-, carbonate methyl-. (2:1). 721.4469 Imidazolethione. 721.4885 Methanone, [5-[[3-(2H-benzotriazol- 721.4470 2,4-Imidazolidinedione, 2-yl)-2-hydroxy-5-(1,1,3,3- bromochloro-5,5-dimethyl-. tetramethylbutyl)phenyl]methyl]-2-hy- 721.4472 Phenyl, alkyl, hydroxyalkyl sub- droxy-4-(octyloxy) phenyl]phenyl-. stituted imidazole (generic). 721.4925 Methyl n-butyl ketone. 721.4473 Dialkylamidoimidazoline. 721.5050 2,2′-[(1-Methylethylidene)bis[4,1- 721.4476 Substituted imines. phenyloxy[1-(butoxymethyl)-(2,1-ethan- 721.4480 2-Imino-1,3-thiazin-4-one-5,6- ediyl]oxymethylene]]bisoxirane, reaction dihydromonohydrochloride. product with a diamine. 721.4484 Halogenated indane (generic name). 721.5075 Mixed methyltin mercaptoester sul- 721.4486 Propanoic acid, 2-methyl-, fides. (1R,2R,4R)-1,7,7- 721.5175 Mitomycin C. trimethylbicyclo[2.2.1]hept-2-yl ester, 721.5185 2-Propen-1-one, 1-(4-morpholinyl)-. rel-. 721.5192 Substituted 1,6-dihydroxy naph- 721.4490 Capped aliphatic isocyanate. thalene. 721.4494 Polycyclic isocyanate. 721.5200 Disubstituted phenylazo trisubsti- 721.4497 Aliphatic polyisocyanates (generic tuted naphthalene. name). 721.5225 Naphthalene,1,2,3,4-tetrahydro(1- 721.4500 Isopropylamine distillation resi- phenylethyl) (specific name). dues and ethylamine distillation resi- 721.5250 Trimethyl spiropolyheterocyclic dues. naphthalene compound. 721.4520 Isopropylidene, bis(1,1-dimethylpro- 721.5252 2-Naphthalenecarboxylic acid, 4,4′- pyl) derivative. methylenebis [3-hydroxy-, zinc salt. 721.4550 Diperoxy ketal. 721.5253 2-Naphthalenecarboxylic acid, 4,4′- 721.4565 Modified hydroxystyrene methylenebis [3-hydroxy-, strontium homopolymer (generic). salt. 721.4568 Methylpolychloro aliphatic ketone. 721.5255 2-Naphthalenol, mono and dioctyl 721.4575 L-aspartic acid, N,N′-[(1E) - 1,2- derivs. ethenediylbis[(3-sulfo-4, 1-phen- 721.5260 1,3,6-Naphthalenetrisulfonic acid, 7- ylene)imino [6-(phenylamino)-1,3,5- [[2-[(aminocarbonyl)amino]-4-[[4-[[2-[2- triazine- 4,2- diyl]]]bis-, hexasodium salt. (ethenylsulfonyl)ethoxy]ethyl]amino]-6- 721.4585 Lecithins, phospholipase A2- fluoro-1,3,5-triazin-2- hydrolyzed. yl]amino]phenyl]azo], trisodium salt. 721.4587 Lithium manganese oxide (LiMn204) 721.5262 2,7-Naphthalenedisulfonic acid, 5- (generic name). [[4-chloro-6-[substituted] amino]-1,3,5- 721.4589 Propanedioic acid, [(4- triazin-2-yl]amino]-4-hydroxy-3-[(1-sulfo- methoxyphenyl)methylene]-, bis(1,2,2,6,6- 2-naphthalenyl)azo]-, trisodium salt (ge- pentamethyl-4-piperdinyl) ester (9CI). neric). 721.4590 Mannich-based adduct. 721.5275 2-Napthalenecarboxamide-N-aryl-3- 721.4594 Substituted azo metal complex dye. hydroxy-4-arylazo (generic name). 721.4596 Diazo substituted carbomonocyclic 721.5276 2-Napthalenol, heptyl-1-[[(4- metal complex. phenylazo)phenyl]azo]-, ar′, ar″-Me 721.4600 Recovered metal hydroxide. derivs. 721.4610 Mixed metal oxides (generic). 721.5278 Substituted naphthalenesulfonic 721.4620 Dialkylamino alkanoate metal salt. acid, alkali salt. 721.4660 Alcohol, alkali metal salt. 721.5279 2,7-Naphthalenedisulfonic acid, 4- 721.4663 Fluorinated carboxylic acid alkali amino-3-[[4′2-amino-4-[(3-butoxy-2- metal salts. hydroxypropyl)amino]phebyl]azo]-3,3′- 721.4668 Hydrated alkaline earth metal salts dimethyl[1,1′-biphenyl]-4-yl]azo]-5-hy- of metalloid oxyanions. droxy-6-(phenylazo)-, disodium salt.

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721.5280 2,7-Naphthalenedisulfonic acid, 4- 721.5380 Mixed alkyl phenolic novolak resin amino-5-hydroxy-, coupled with (generic). diazotized 4-butylbenzenamine, 721.5385 Octanoic acid, hydrazide. diazotized 4,4′- 721.5400 3,6,9,12,15,18,21-Heptaoxatetra- cyclohexylidenebis[benzenamine] and m- triaoctanoic acid, sodium salt. phenylenediamine, sodium salt. 721.5425 a-Olefin sulfonate, potassium salts. 721.5281 2-Naphthalenesulfonic acid, 3-[[4- 721.5450 a-Olefin sulfonate, sodium salt. [(2,4-dimethyl-6-sulfophenyl)azo]-2- 721.5452 Alkali metal salt of halogenated methoxy-5-methylphenyl]azo]-4-hydroxy- organoborate (generic). 7-(phenylamino)-, sodium salt, compd. 721.5454 Methylium, tripohenyl-, With 2,2′,2″-nitrilotris [ethanol] (9CI). tetrakis(pentafluorophenyl) borate (1-). 721.5282 Trisodium chloro [(trisubstituted 721.5460 Organosolv lignin. heteromonocycle amino) 721.5465 Amine salt of organic acid (ge- propylamino]triazinylamino hydroxyazo neric). naphthalenetrisulfonate. 721.5475 1-Oxa-4-azaspiro[4.5]decane, 4-di- 721.5283 Cobaltate (5-), bis[4-[[6-[(4-amino-6- chloroacetyl-. chloro-1,3,5-triazin-2-yl)amio]-1-hydroxy- 721.5500 7-Oxabicyclo[4.1.0]heptane, 3-eth- 3-sulfo-2-naphthalenyl]azo]-3-hydroxy-7- enyl, homopolymer, ether with 2-ethyl-2- nitro-1-naphthalenesulfonato(4-)]-, (hydroxymethyl)-1,3-propanediol (3:1), pentasodium. epoxidized. 721.5284 Chromate (5-), bis[4-hydroxy-7-[(2- 721.5525 Substituted spiro oxazine. hydroxy-1-naphthalenyl)azo]- 3-[(2-hy- 721.5540 1H,3H,5H-oxazolo [3,4-c] oxazole, droxy-3-nitro-5-sulfophenyl)azo]-2- dihydro-7a-methyl-. naphthalenesulfonato(4-)]-, pentasodium. 721.5545 3-(Dichloroacetyl)-5-(2-furanyl)-2,2- dimethyl-oxazolidine. 721.5285 Ethoxylated substituted naphthol. 721.5546 Halogen substituted oxetanes (ge- 721.5286 Benzenediazonium, [[[[(sub- neric). stituted)azo]phenyl]sulfonyl]amino]-, 721.5547 Antimony double oxide. coupled with aminophenol, diazotized 721.5548 Mixed metal oxide (generic). aminobenzoic acid, diazotized (sub- 721.5549 Lithiated metal oxide. stituted) benzenesulfonic acid and 721.5550 Substituted dialkyl oxazolone (ge- naphthalenol (generic). neric name). 721.5288 Chromate(2-), [3-hydroxy-4-[(2-hy- 721.5560 Formaldehyde, polymer with droxy-1-naphthenyl)azo]-7-nitro-1-sub- (chloromethyl) oxirane and phenol, reac- stituted][N-[7-hydroxy-8-[(2-hydroxy-5- tion products with 6H- nitrophenyl)azo]-1-substituted]-, salt (ge- dibenz[c,e][1,2]oxaphosphorin-6-oxide. neric). 721.5575 Oxirane, 2,2′-(1,6-hexanediylbis 721.5290 Phenylazoalkoxy naphthylamines (oxymethylene)) bis-. (generic). 721.5580 Oxirane, 2,2′-[methylenebis[(2,6-di- 721.5293 Poly(oxy-1,2-ethanediyl), alpha- methyl-4,1-phenylene)oxymethylene]]bis- (9Z)-9-octadecenyl-.omega.-hydroxy-, . phosphate, ammonium salt. 721.5585 4,4′-(1-methylethylidene)bisphenol, 721.5310 Neononanoic acid, ethenyl ester. polymer with (chloromethyl)oxirane and 721.5315 Nickel, cobalt mixed metal oxide a diamine (generic). (generic). 721.5590 Oxirane, [[[(1R,2S,5R)-5-methyl-2-(1- 721.5325 Nickel acrylate complex. methylethyl)cyclohexyl]oxy]methyl]-. 721.5330 Nickel salt of an organo compound 721.5600 Substituted oxirane. containing nitrogen. 721.5625 Oxiranemethanamine, N,N′- 721.5340 Substituted benzothiazole-azo-sub- [methylenebis(2-ethyl-4,1-phen- stituted benzoquinoline nickel complex ylene)]bis[N-(oxiranylmethyl)]-. (generic). 721.5645 Pentane 1,1,1,2,3,4,4,5,5,5,- 721.5350 Substituted nitrile (generic name). decafluoro. 721.5356 Ethanol, 2,2′2″-nitrilotris-, com- 721.5650 Pentanediol light residues. pound with alpha-2,4,6-tris (1- 721.5700 Pentanenitrile, 3-amino-. phenylethyl)phenyl]-omega-hydroxypoly 721.5708 2-Pentene, 1,1,1,2,3,4,4,5,5,5- (oxy-1,2-ethanediyl) phosphate. decafluoro-. 721.5358 2-propanol, 1,1′,1′-nitrilotris-, 721.5710 Phenacetin. compds. with ethanol 2-[2-(C12–14- 721.5713 Phenol - biphenyl polymer conden- alkyloxy) ethoxy] derivs. hydrogen sul- sate (generic). fates. 721.5740 Phenol, 4,4′-methylenebis (2,6-di- 721.5360 Substituted nitrobenezene (ge- methyl-. neric). 721.5760 Phenol, 4,4′-[methylenebis (oxy-2,1- 721.5375 Nitrothiophenecarboxylic acid, ethanediylthio)]bis-. ethyl ester, bis[[[[(substituted)] 721.5762 Aromatic aldehyde phenolic resin amino]alkylphenyl]azo] (generic name). (generic). 721.5378 9-Phosphabicyclo[3.3.1]nonane,9,9′- 721.5763 Methylenebisbenzotriazolyl phe- (1,2-ethanediyl)bis- (9C1). nols.

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721.5769 Mixture of nitrated alkylated phe- 721.6110 Alkyldi(alkyloxyhydroxypropyl) nols. derivative, phosphoric acid esters, potas- 721.5775 Phenol, 5-amino-2,4-dicholoro-, hy- sium salts. drochloride. 721.6120 Phosphoric acid, 1,2-ethanediyl 721.5780 Phenol, 4,4′-(oxybis(2,1-ethanediyltetrakis(2-chloro-1-methylethyl) ester. thio)bis-. 721.6140 Dialkyldithiophosphoric acid, ali- 721.5800 Sulfurized alkylphenol. phatic amine salt. 721.5820 Aminophenol. 721.6160 Piperazinone, 1,1′,1″-[1,3,5-triazine- 721.5840 Ethylated aminophenol. 2,4,6-triyltris[(cyclohexylimino)-2,1- 721.5860 Methylphenol, bis(substi- ethanediyl]]tris-[3,3,4,5,5-pentamethyl]-. tuted)alkyl. 721.6165 Polysubstituted piperidine. 721.5867 Substituted phenol. 721.6167 Piperdinium, 1,1-dimethyl-, chlo- 721.5880 Sulfur bridged substituted phenols ride. (generic name). 721.6170 Siloxanes and silicones, Me hydro- 721.5900 Trisubstituted phenol (generic gen, reaction products with 2,2,6,6- name). tetramethyl-4-(2-propenyloxy)piperdine. 721.5905 Modified phenolic resin (generic). 721.6175 2-Piperdinone, 1,3-dimethyl-,. 721.5908 Modified phenolic resin (generic). 721.6176 2-Piperdinone, 1,5-dimethyl-,. 721.5912 Phenoxazin-5-ium, 3-dialkylamino- 721.6178 Alkylaminated polyolefin (generic). 7-arylamino-, salt (generic). 721.6180 Polyalkylene glycol polyamide 721.5913 Phenothiazine derivative. ester phosphate (generic). 721.5914 Polysubstituted bis 721.6181 Fatty acid, reaction product with phenylazonapthalene disulfonic acid (ge- substituted oxirane, formaldehyde-phe- neric). nol polymer glycidyl ether, substituted 721.5915 Polysubstituted phenylazopoly- proplyamine and substitutedphenyl dye. polyethylenepolyamines (generic). 721.5917 Phenyl azo dye (generic). 721.6183 Amides, from ammonium hydroxide 721.5920 Phenyl(disubstitutedpolycyclic). - maleic anhydride polymer and hydro- 721.5925 Bis heterocyclic phenylene deriva- genated tallow alkyl amines, sodium tive (generic). salts, compds. with ethanolamine. 721.5930 Phenylenebis[imino 721.6186 Polyamine dithiocarbamate. (chlorotriazinyl)-imino (substituted 721.6193 Polyalkylene polyamine. napthyl)azo (substituted phenyl)azo, so- 721.6196 Hydrochloride salt of a fatty dium salt (generic name). polyalkkylene polyamine (generic). 721.5935 Alkylated nitroso- 721.6200 Fatty acid polyamine condensate, phenylenediamine (generic). phosphoric acid ester salts. 721.5960 N,N′-Bis(2-(2-(3-alkyl)thiazoline) 721.6205 Hexamethylenediamine adduct of vinyl)-1,4-phenylenediamine methyl sul- substituted piperidinyloxy (generic). fate double salt (generic name). 721.6220 Aryl sulfonate of a fatty acid mix- 721.5965 Substituted S-phenylthiazole (ge- ture, polyamine condensate. neric). 721.6440 Polyamine ureaformaldehyde con- 721.5970 Phosphated polyarylphenol densate (specific name). ethoxylate, potassium salt. 721.6470 Polyaminopolyacid. 721.5980 Dialkyl phosphorodithioate phos- 721.6475 Alkyl polycarboxylic acids, esters phate compounds. with ethoxylated fatty alcohols. 721.5985 Fatty alkyl phosphate, alkali metal 721.6477 Alkyl polycarboxylic acids, esters salt (generic). with ethoxylated fatty alcohols, reaction 721.6000 Tris (2,3-dibromopropyl) phosphate. products with maleic anhydride. 721.6005 Rare earth phosphate (generic). 721.6479 Tetrahydroheteropolycycle (ge- 721.6020 Phosphine, dialkylyphenyl. neric). 721.6045 Phosphinothioic acid, bis(2,4,4- 721.6485 Hydroxy terminated polyester. trimethylpentyl)- (9CI). 721.6490 Alkyl phenyl polyetheramines. 721.6060 Alkylaryl substituted phosphite. 721.6493 Amidoamine modified polyethylene 721.6070 Alkyl phosphonate ammonium glycol (generic). salts. 721.6495 Aliphatic polyisocyanate. 721.6075 Phosphonic acid, 1,1-methylenebis- 721.6498 Modified polyisocyanates (generic). tetrakis(1-methylethyl) ester. 721.6505 Polymers of C13C15 oxoalcohol 721.6078 Substituted ethoxyethylamine ethoxolates. phosphonate. 721.6515 Polymerof polyalkylenepolyol and 721.6080 Phosphonium salt (generic name). trisubstituted phenol (generic). 721.6085 Phosphonocarboxylate salts. 721.6520 Acrylamide, polymer with sub- 721.6090 Phosphoramide. stituted alkylacrylamide salt (generic 721.6097 Phosphoric acid derivative (generic name). name). 721.6540 Acrylamide, polymers with 721.6100 Phosphoric acid, C6-12-alkyl esters, tetraalkyl ammonium salt and compounds with 2-(dibutylamino) eth- polyalkyl, aminoalkyl methacrylamide anol. salt.

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721.6560 Acrylic acid, polymer with sub- 721.7500 Nitrate polyether polyol (generic stituted ethene. name). 721.6620 Alkanaminium, polyalkyl-[(2-meth- 721.7600 Alkyl(heterocyclicyl) phenylazohe- yl-1-oxo-2-propenyl)oxy] salt, polymer tero monocyclic polyone (generic name). with acrylamide and substituted alkyl 721.7620 Alkyl(heterocyclicyl) phenylazohe- methacrylate. tero monocyclic polyone, 721.6660 Polymer of alkanepolyol and poly- ((alkylimidazolyl) methyl) derivative alkylpolyisocyanatocarbomonocycle, ac- (generic name). etone oxime-blocked (generic name). 721.7655 Alkylsulfonium salt. 721.6680 Alkanoic acid, butanediol and 721.7700 Poly(oxy-1,2-ethanediyl), a-hydro-w- cyclohexanealkanol polymer (generic (oxiranylmethoxy)-, ether with 2-ethyl-2- name). (hydroxymethyl)-1,3-propanediol (3:1). 721.6900 Polymer of bisphenol A diglycidal 721.7710 Polyepoxy polyol. ether, substituted alkenes, and buta- 721.7720 Poly(oxy-1,2-ethanediyl), a,a′-[(1- diene. methylethylidene) di-4,1-phenylene] bis 721.6920 Butyl acrylate, polymer with sub- [w-(oxiranylmethoxy)-. stituted methyl styrene, methyl meth- 721.7770 Alkylphenoxypoly(oxyethylene) acrylate, and substituted silane. sulfuric acid ester, substituted amine 721.6980 Dimer acids, polymer with polyal- salt. kylene glycol, bisphenol A-diglycidyl 721.7780 Poly[oxy(methyl-1,2-ethanediyl)], ether, and alkylenepolyols polyglycidyl a,a′-(2,2-dimethyl-1,3-propanediyl)bis[w- ethers (generic name). (oxiranymethoxy)-. 721.7000 Polymer of disodium maleate, allyl 721.7785 Substituted alkyl aminomethylene ether, and ethylene oxide. polyphosphonic acid, salt (generic). 721.7020 Distillates (petroleum), C(3-6), poly- 721.8079 Isophorone diisocyanate neopentyl mers with styrene and mixed terpenes glycol adipate polyurethane prepolymer. (generic name). 721.8082 Polyester polyurethane acrylate. 721.7046 Formaldehyde, polymer with sub- 721.8085 Reaction product of substituted ar- stituted phenols, glycidyl ether. omatic diol, formaldehyde and 721.7160 2-Oxepanone, polymer with 4,4′-(1- alkanolamine, propoxylated (generic). methylethylidene)bisphenol and 2,2-[(1- 721.8090 Polyurethane polymer. methylethylidene)bis(4,1-phenyleneoxy- 721.8095 Silylated polyurethane. methylene)]bisoxirane, graft. 721.8100 Potassium N,N-bis (hydroxyethyl) 721.7200 Perfluoroalkyl aromatic carbamate cocoamine oxide phosphate, and potas- modified alkyl methacrylate copolymer. sium N,N-bis (hydroxyethyl) tallowamine 721.7210 Epoxidized copolymer of phenol and oxide phosphate. substituted phenol. 721.8130 Propanamide, -(2-hydroxyethyl)-3- 721.7220 Polymer of substituted phenol, methoxy-. formaldehyde, epichlorohydrin, and 721.8140 Substituted propane (generic). disubstituted benzene. 721.8145 Propane,1,1,1,2,2,3,3-heptafluoro-3- 721.7250 Polyaziridinyl ester of an aliphatic methoxy-. alcohol (generic). 721.8153 Di-substituted propanedione (ge- 721.7255 Polyethyleneamine crosslinked neric). with substituted polyethylene glycol (ge- 721.8155 Propanenitrile, 3-[amino, N- neric). tallowalkyl] dipropylenetri- and 721.7260 Polymer of polyethylenepolyamine tripropylenetri- and propanenitrile, 3- and alkanediol diglycidyl ether. [amino, (C14-18 and C16-18 unsaturated 721.7270 1-propanaminium, 3-amino-, N,N,N- alkyl)] trimethylenedi-, dipropylenetri-, trimethyl-N-soya acyl derivs., chloride. and tripropylenetetra-. 721.7280 1,3-Propanediamine, N,N′-1,2-ethan- 721.8160 Propanoic acid, 2,2-dimethyl-, eth- ediylbis-, polymer with 2,4,6-trichloro- enyl ester. 1,3,5-triazine, reaction products with N- 721.8175 1-Propanol, 3-mercapto-. butyl-2,2,6,6-tetramethyl-4-piperi- 721.8225 2-Propenamide, N-[3-dimethyl- dinamine. amino)propyl]-. 721.7285 Amines, N- 721.8250 1-Propanol, 3,3′-oxybis[2,2- cocoalkyltrimethylenedi-, citrates. bis(bromomethyl)-. 721.7286 Amines, N- 721.8340 Mono esters from 2- propenoic acid tallowalkyltripropylenetetra-, citrates. (generic). 721.7290 Propanoic acid, 2-(trimethoxysilyl)- 721.8350 2-Propenoic acid, 7- , ethyl ester. oxabicyclo[4.1.0]hept-3-ylmethyl ester. 721.7375 Potassium salt of polyolefin acid. 721.8450 2-Propenoic acid, 2-methyl-, 2-[3- 721.7378 Substituted polyoxyethylene. (2H-benzotriazol-2-yl)-4- 721.7440 Polyalkylenepolyol alkylamine. hydroxyphenyl]ethyl ester. (generic name). 721.8485 2-Propenoic acid, 2-methyl-, 721.7450 Aromatic amine polyols. (octahydro-4,7-methano-1H- indene-5- 721.7480 Isocyanate terminated polyols. diyl)bis(methylene) ester.

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721.8500 2-Propenoic acid, 2-methyl-, 7- 721.9280 Reaction product of ethoxylated oxabicyclo [4.1.0]hept-3-ylmethyl ester. fatty acid oils and a phenolic pentaeryth- 721.8657 Cerium, hydroxy oleate propionate ritol tetraester. complexes. 721.9285 Reaction products of formalin (37%) 721.8658 Modified polymer of vinyl acetate with amine C12. and quaternary ammonium compound 721.9300 Reaction products of substituted (generic). hydroxyalkanes and polyalkylpolyiso- 721.8660 Propionic acid methyl ester (ge- cyanatocarbomonocycle. neric). 721.9400 Reaction product of phenolic penta- 721.8670 Alkylcyano substituted pyridazo erythritol tetraesters with fatty acid benzoate. esters and oils, and glyceride triesters. 721.8673 [(Disubstituted phenyl)]azo dihydro 721.9460 Tall oil fatty acids, reaction prod- hydroxy alkyl oxo alkyl-substituted- ucts with polyamines, alkyl substituted. pyridines (generic name). 721.9470 Reserpine. 721.8675 Halogenated pyridines. 721.9480 Resorcinol, formaldehyde sub- 721.8700 Halogenated alkyl pyridine. stituted carbomonocycle resin (generic). 721.8750 Halogenated substituted pyridine. 721.9484 Dimer acid/rosin amidoamine reac- 721.8775 Substituted pyridines. tion product (generic). 721.8780 Substituted pyridine azo sub- 721.9485 Dimer acid/polymerized rosin stituted phenyl. amidoamine reaction product (generic). 721.8825 Substituted methylpyridine and 721.9486 Roxin amidoamine (generic). substituted 2-phenoxypyridine. 721.9487 Polymerized rosin amidoamine (ge- 721.8850 Disubstituted halogenated pyridi- neric). nol. 721.9488 Substituted resorcinols. 721.8875 Substituted halogenated pyridinol. 721.9490 Coco alklydimethyl amine salts 721.8900 Substituted halogenated pyridinol, (generic). alkali salt. 721.9492 Polymers of styrene, cyclohexyl 721.8920 4,6-Disubstituted pyrimidine (ge- methacrylate and substituted methacry- neric). late. 721.8940 Chromate(3-), bis[3-[[6-amino-1,4- dihydro-2-[[[4-[(2-hydroxy-1- 721.9495 Acrylosilane resins. naphthalenyl)azo] phenyl]sulfonyl] 721.9497 Trifunctional ketoximino silane. amino]-4-(oxo-.kappa.O)-5- 721.9499 Modified silicone resin. pyrimidinyl]azo-.kappaN1] -4-hydroxy- 721.9500 Silane, (1,1-dimethylethoxy) di- .kappa.O)-5-nitrobenzenesulfonato(3-)]-, methoxy(2-methyl propyl)-. trisodium. 721.9501 Silane, triethoxy[3- 721.8950 Chromate(3-), bis[3-[[6-amino-1,4- oxiranylmethoxy)propyl]-. dihydro-2-[[[4-[(2-hydroxy-1- 721.9502 Siloxanes and silicones, naphthalenyl)azo] aminoalkyl, fluorooctyl, hydroxy-termi- phenyl]sulfonyl]amino]-4-(oxo-.kappa.O)- nated salt (generic). 5-pyrimidinyl]azo-.kappaN1]-4-hydroxy- 721.9503 Silane, .kappa.O)-5-nitrobenzenesulfonato(3-)]-, (3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10- sodium triethanolamine salts. heptadecafluorodecyl)trimethoxy-. 721.8965 1H-Pyrole-2, 5-dione, 1-(2,4,6- 721.9504 Silane, triethoxy (3,3,4,4,5,5, tribromophenyl)-. 6,6,7,7,8,8,8-tridecafluorooctyl)-. 721.9000 N-Nitrosopyrrolidine. 721.9505 Silanes substituted macrocycle 721.9005 2-Pyrrolidinone, 1,1′-(2-methyl-1,5- polyethyl. pentanediyl)bis-. 721.9506 Halogenated arylsilane (generic). 721.9010 2-pyrrolidone, 1-ethenyl-3-ethyl- 721.9507 Polyester silane. idene-, (E)-. 721.9508 Perfluorinatedalkyl 721.9075 Quaternary ammonium salt of polyhydroxysilane (generic). fluorinated alkylaryl amide. 721.9509 Perfluorinatedalkyl 721.9078 6-Methoxy-1H-benz[de]isoquinoline- polyalkoxysilane (generic). 2 [3H]-dione derivative (generic). 721.9511 Silicic acid (H6SiO2O7), magnesium, 721.9079 Dihydro quinacridone derivative strontium salt(1:1:2), dysprosium and eu- (generic). ropium-doped. 721.9080 Nitro methyl quinoline. 721.9513 Modified magnesium silicate poly- 721.9100 Substituted quinoline. mer (generic). 721.9220 Reaction products of secondary 721.9514 Ethyl silicate, reaction products alkyl amines with a substituted with modified alkoxysilane salt (ge- benzenesulfonic acid and sulfuric acid neric). (generic name). 721.9515 Aminofunctional alkoxy alkyl si- 721.9265 Reaction product of loxane. dichlorobenzidine and substituted 721.9516 Siloxanes and silicones, 3-[(2- alkylamide. aminoethyl) amino]propyl Me, di-Me, re- 721.9270 Reaction product of epoxy with an- action products with polyethylene-poly- hydride and glycerol and glycol. propylene glycol Bu glycidal ether.

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721.9517 Siloxanes and silicones, de-Me, 3-[4- 721.9660 Methylthiouracil. [[[3-(dimethyl amino) propyl] 721.9661 Diphenol tars (generic). amino]carbonyl]-2-oxo-1-pyrrolidinyl] 721.9662 Thieno[3,4-b]-1,4-dioxin, 2,3-dihydro- propyl Me. (9CI). 721.9518 Sinorhizobuim meliloti strain 721.9663 Poly(oxy-1,2-ethanediyl), alpha, RMBPC–2. alpha′-[thiobis (1-oxo-3,1-propanediyl)]bis 721.9520 Methylated-para-rosaniline salt of a [omega-hydroxy-,bis (C11–15 and trisulfonated triarylmethane dye (ge- C11–15–isoalkyl) ethers. neric). 721.9664 9H-Thioxanthen-9-one,2,4-diethyl. 721.9526 Sodium perthiocarbonate. 721.9665 Organotin catalysts. 721.9527 Bis(1,2,2,6,6-pentamethyl-4- 721.9668 Organotin lithium compound. piperidin-4-ol) ester of cycloaliphatic 721.9670 Tetraaryltin (generic). spiroketal. 721.9671 Triaryltin (generic). 721.9530 Bis(2,2,6,6-tetramethylpiperidinyl) 721.9672 Amides, tall-oil fatty, N-[2-[2-hy- ester of cycloalkyl spiroketal. droxyethyl)amino]ethyl], reaction prod- 721.9535 1,4-Dioxa-7,9-dithia-8- ucts with sulfur dioxide; fatty acids, tall- stannacycloundecane-5,11-dione, 8,8- oil, reaction products with 1- dioctyl-. piperazineethanamine and sulfur dioxide; 721.9538 Lithium salt of sulfophenyl azo fatty acids, tall-oil reaction products phenyl azo disulfostilbene (generic). with sulfur dioxide and 721.9540 Polysulfide mixture. triethylenetetramine. 721.9545 Substituted phenyl azo substituted 721.9674 Sulfonated-copper phthalocyanine sulfocarbopolycle, sodium salt. salt of a triarylmethane dye (generic). 721.9550 Sulfonamide. 721.9675 Titanate [Ti O (2-)], dipotassium. 721.9570 Halophenyl sulfonamide salt. 6 13 721.9680 Alkaline titania silica gel (generic 721.9572 Substituted alkyl sulfonamide (ge- name). neric). 721.9685 Mixed trialkylamines (generic). 721.9573 Substituted perfluoroalkyl sul- 721.9700 Monosubstituted alkoxyaminotra- fonamide (generic). zines (generic name). 721.9575 Chromate(3-), bis[3-[[5- (aminosulfonyl)-2-hydroxyphenyl]azo]-4- 721.9717 Azo monochloro triazine reactive hydroxy-7-[[2-oxo-1- dye. [(phenylamino)carbonyl] propyl]azo]-2- 721.9719 Tris carbamoyl triazine (generic). naphthalenesulfonato(3-)]-, trisodium 721.9720 Disubstituted alkyl triazines (ge- (9CI). neric name). 721.9576 Chromate(3-), bis[7- 721.9730 1,3,5-Triazin-2-amine, 4- [(aminohydroxyphenyl)azo]-3-[[5- dimethylamino-6-substituted-. (aminosulfonyl)-2-hydroxyphenyl]azo]-4- 721.9740 Brominated triazine derivative. hydroxy-2-naphthalene-sulfonato (3-)]-, 721.9750 2-Chloro-4,6-bis(substituted)-1,3,5- trisodium (9CI). triazine, dihydrochloride. 721.9577 Chromate(3-), bis[7- 721.9790 Benzenesulfonic acid, 2,2′-(1,2- [(aminohydroxyphenyl)azo]-3-[[5- ethenediyl)bis[5-[[4-[bis(2-hydroxypropyl) (aminosulfonyl)-2-hydroxyphenyl] azo]-4- amino]- 6-[(3-sulfophenyl)amino]-1,3,5- hydroxy-2-naphthalene sulfonato (3-)]-,- triazin-2-yl]amino]-, disodium salt, [[5-(aminosulfonyl) -2- compd. with 2,2′,2″-nitrilo-tris[ethanol] hydroxyphenyl]azo]-4-hydroxy-7-[[2-hy- (1:2); Benzenesulfonic acid, 5-[[4-[bis(2-hydroxy-1-[(phenylamino) carbonyl]-1-pro- droxyethyl)amino]-6-[(3- penyl]azo]-2-naphthalenesulfonato(3-)]-, sulfophenyl)amino]-1,3,5-triazin-2- trisodium (9CI). yl]amino]-2-[2-[4-[[4-[bis(2- 721.9580 Ethyl methanesulfonate. hydroxypropyl)amino]-6-[(3- 721.9582 Certain perfluoroalkyl sulfonates. sulfophenyl)amino]-1,3,5-triazin-2- 721.9595 Alkyl benzene sulfonic acids and yl]amino]-2-sulfophenyl]ethenyl]-, diso- alkyl sulfates, amine salts (generic). dium salt, compd. with 2,2′,2″- 721.9597 Salt of a substituted sulfonated nitrilotris[ethanol] (1:2). aryl azo compound (generic). 721.9795 Benzenesulfonic acid, 2,2′-(1,2- 721.9620 Aromatic sulfonic acid compound ethenediyl)bis[(4,6-dichloro-1,3,5-triazin- with amine. 2-yl) amino]-, disodium salt, substituted 721.9630 Polyfluorosulfonic acid salt. with dialkyl amines (generic). 721.9635 Terpene residue distillates. 721.9798 Benzenesulfonic acid, 2,2′-(1,2- 721.9640 Salt of an acrylic acid – acrylamide ethenediyl)bis[5-[[4-substituted-6-sub- terpolymer (generic). stituted-1,3,5-triazin-2-yl]amino]-, so- 721.9650 Tetramethylammonium salts of dium salt (generic). alkylbenzenesulfonic acid. 721.9800 Poly(substituted triazinyl) piper- 721.9656 Thiaalkanethiol. azine (generic name). 721.9657 Disubstituted thiadiazole. 721.9820 Substituted triazole. 721.9658 Thiadiazole derivative. 721.9825 Phenyl substituted triazolinones. 721.9659 Disubstituted thiadiazosulfone. 721.9830 1-Tridecyn-3-ol, 3-methyl.

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721.9840 Tungstate (W12(OH)2O386-) 721.10019 Benzoic acid, 2-chloro-5-nitro-, 1,1- hexasodium (9CI). dimethyl-2-oxo-2-(2-propenyloxy) ethyl 721.9850 2,4,8,10-Tetraoxa-3,9- ester. diphosphaspiro[5.5]undecane, 3,9-bis[2,4,6- 721.10020 Benzoic acid, 5-amino-2-chloro-, tris(1,1-dimethylethyl)phenoxy]-. 1,1-dimethyl-2-oxo-2-(2-propenyloxy) 721.9892 Alkylated urea. ethyl ester. 721.9900 Urea, condensate with 721.10021 Magnesium potassium titanium poly[oxy(methyl-1,2ethanediyl)]-a- (2- oxide. aminomethylethyl)-μ-(2-amino- 721.10022 Benzenamine, N-phenyl-, ar′-(C9- ethylethoxy) (generic name). rich C8-10-branched alkyl) derivs. 721.9920 Urea, (hexahydro-6-methyl-2-oxopy- 721.10023 Benzenamine, N-phenyl-, ar ar′-(C9- rimidinyl)-. rich C8-10-branched alkyl) derivs. 721.9925 Aminoethylethylene urea 721.10024 10H-Phenothiazine, ar-(C9-rich methacrylamide. C8-10-branched alkyl) derivs. 721.9928 Urea, tetaethyl-. 721.10025 10H-Phenothiazine, ar, ar′-(C9-rich 721.9929 Polyurea (generic). C8-10-branched alkyl) derivs. 721.9930 Urethane. 721.10026 Cashew, nutshell liq., ethoxylated. 721.9952 Alkoxylated aliphatic diisocyanate 721.10027 Ethoxylated alkylsulfate, sub- allyl ether (generic). stituted alkylamine salt (generic). 721.9957 N-Nitroso-N-methylurethane. 721.10028 Disubstituted benzene metal salts 721.9959 Polyurethane polymer (generic). (generic). 721.9965 Fatty acids, C10-13 - branched, vinyl 721.10029 Isocyanate compound, modified esters. with methoxysilane (generic). 721.9969 3,6-Bis(dialkylamino) -9-[2- 721.10030 Pyrimido[5,4-g]pteridine-2,4,6,8- alkoxycarbonyl) phenyl]-xanthylium salt tetramine, 4-methylbenzenesulfonate, (generic). base-hydrolyzed. 721.9970 o-Xylene compound (generic name). 721.10031 Lithium potassium titanium 721.9973 Zirconium dichlorides (generic). oxide. 721.10000 Certain polybrominated 721.10032 Acrylic acid, polymer with sub- diphenylethers. stituted acrylamides (generic). 721.10001 2-Ethoxyethanol, 2-ethoxyethanol 721.10033 Zinc, [ethanedioato(2-)-. kappa. O1, acetate, 2-methoxyethanol, and 2- . kappa. O2]-. methoxyethanol acetate. 721.10034 Substituted pyridine coupled with 721.10002 2-Thiazolidinone. diazotized substituted nitrobenzonitrile, 721.10003 Manganese heterocyclic diazotized substituted benzenamine and tetraamine complex (generic). substituted pyridinecarbonitrile (ge- 721.10004 2-Butenoic acid, 4,4′- neric). [(dibutylstannylene)bis(oxy)]bis[4-oxo-, 721.10035 Alkylbenzene sulfonate (generic). (2Z,2′Z)-, di-C8-10-isoalkyl esters, C9-rich. 721.10036 Acetaldehyde based polymer (ge- 721.10005 2-Butenoic acid, 4,4′- neric). [(dibutylstannylene)bis(oxy)]bis [4-oxo-, 721.10037 Complex halogenated salt of (2Z,2′Z)-, di-C9-11-isoalkyl esters, C10-rich. tris(ethylatedaminocarbocyclic)methane 721.10006 Mixed metal oxide (generic). (generic). 721.10007 Alcohols, C12-14- secondary, 721.10038 Trimellitic anhydride, polymer ethoxylated propoxylated. with substituted glycol, alkyl phenols 721.10008 Manganese strontium oxide and ethoxylated nonylphenol (generic). (MnSrO3). 721.10039 Diethoxybenzenamine derivative, 721.10009 Manganese yttrium oxide (MnYO3). diazotized, coupled with 721.10010 Barium manganese oxide aminonaphthalenesulfonic acid deriva- (BaMnO3). tive, ammonium salt (generic). 721.10011 Barium calcium manganese stron- 721.10040 Substituted acridine naphtha sub- tium oxide. stituted benzamide (generic). 1- 721.10012 Manganate (MnO2 ), calcium (2:1). 721.10041 1-Butanone, 2-(dimethylamino)-2- 721.10013 Manganese yttrium oxide [(4-methylphenyl)methyl]-1-[4-(4- (Mn2YO5). morpholinyl)phenyl]-. 721.10014 Halogenated naphthalic anhydride 721.10042 2-Propanol, 1-[bis(2-hydroxy- (generic). ethyl)amino]-. 721.10015 Halogenated benzimidazole (ge- 721.10043 Dineopentyl-4-substituted phthal- neric). ate (generic). 721.10016 Dibenzimidazothianaphthalene 721.10044 Metal oxide, modified with alkyl (generic). and vinyl terminated polysiloxanes (ge- 721.10017 Amine terminated bisphenol A neric). diglycidyl ether polymer (generic). 721.10045 Diazotized substituted 721.10018 Calcium hydroxide oxide silicate heteromonocycle coupled with naph- (Ca6(OH)2O thalene sulfonic acid derivative, nickel 2(Si2O5)3). complex, alkaline salt (generic). 167

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721.10046 Polyaromatic amine phosphate 721.10073 Modified alkyl acrylamide (ge- (generic). neric). 721.10047 Polyphosphoric acids, compds. 721.10074 Acetic acid, 2-chloro-, 1-(3,3- with piperazine. dimethylcyclohexyl)ethyl ester. 721.10048 Substituted anthraquinone (ge- 721.10075 Carbon black, 4-[[2-(Sulfooxy) neric). ethyl]substituted] phenyl- modified, so- 721.10049 Phenol, 4,4′- cyclohexylidene bis[2- dium salts (generic). methyl-. 721.10076 Substituted benzenediamine (ge- 721.10050 Disubstituted-N′- hydroxy- neric). benzenecarboximidamide (generic). 721.10077 3H-1,2,4-Triazol-3-one, 1,2-dihydro-. 721.10051 Spiro naphthoxazine (generic). 721.10078 Butanamide, 2-[(2-methoxy-4- 721.10052 Aminoalkyl substituted nitrophenyl)azo]-N-(2-methoxyphenyl)-3- alkylphenol (generic). oxo-, 4-[(17-substituted-3,6,9,12,15- 721.10053 Alkyl silane methacrylate (ge- pentaazaheptadec-1- neric). yl)substituted]phenyl derivs., 721.10054 Phenol, polymer with formalde- hydrochlorides (generic). hyde, 3-[(2-aminocyclohexyl)amino]-2- 721.10079 Quino[2,3-b]acridine-7, 14-dione, hydroxypropyl ethers. 5,12-dihydro-2,9-dimethyl-, 4-[(17-sub- 721.10055 1-Propanaminium, 3-amino-N- stituted-3,6,9,12,15-pentaazaheptadec-1- (carboxymethyl)-N,N-dimethyl-, N-soya yl)substituted]phenyl derivs., acyl derivs., inner salts. hydrochlorides (generic). 721.10056 Benzenemethanaminium, N-(3- 721.10080 Carbon black, 4-[(17-substituted- aminopropyl)-N,N-dimethyl-, N-soya acyl 3,6,9,12,15-pentaazaheptadec-1-yl) sub- derivs., chlorides. stituted] phenyl-modified, 721.10057 Dodecanedioic acid, 1, 12- hydrochlorides (generic). dihydrazide. 721.10081 Aromatic urethane acrylate 721.10058 Reaction product of alkylphenol, oligomer (generic). aromatic cyclicamine, alkyl diglycidyl 721.10082 Amine modified monomer acrylate dibenzene, and formaldehyde (generic). (generic). 721.10059 Reaction product of alkylphenyl 721.10083 Copper, [29H, 31H- glycidyl ether, polyalkylenepolyamine, phthalocyaninato (2-)-N29, N30, N31, N32]- and alkyl diglycidyl dibenzene (generic). , 4-[(17-substituted-3,6,9,12,15- 721.10060 Reaction product of alkylphenyl pentaazaheptadec-1-yl) substituted] glycidyl ether, polyalkylenepolyamine, phenyl derivs., hydrochlorides (generic). alkyl diglycidyl dibenzene, and 721.10084 Modified thionocarbamate (ge- polyalkylcyclicdiamine (generic). neric). 721.10061 Pentane, 1,1,1,2,2,3,4,5,5,5- 721.10085 Substituted polyaryl sulfonium decafluoro-3-methoxy-4- polyhalide phosphate salt (generic). (trifluoromethyl)-. 721.10086 Ethane, 2-(difluoromethoxy)-1,1,1- 721.10062 2,5-Furandione, polymer with trifluoro-. oxybis[propanol], benzoate. 721.10087 Substituted alkyl phosphine oxide 721.10063 Halo substituted hydroxy (generic). nitrophenyl amide (generic). 721.10088 Thiophene, 2,5-dibromo-3-hexyl-. 721.10064 2-Propenoic acid, 2-[2- 721.10089 Modified salicylic acid, zirconium (ethenyloxy)ethoxy]ethyl ester. complex (generic). 721.10065 1-Tetradecanesulfonic acid, 721.10090 Tertiary amine salt of glycol suc- (dimethylphenyl)-. cinate (generic). 721.10066 1-Hexanesulfonic acid, 721.10091 2(1H)-Pyrimidinone, tetrahydro- (dimethylphenyl)-. 1,3-dimethyl-. 721.10067 Ether amine phosphonate salt (ge- 721.10092 Poly(oxy-1,2-ethanediyl), .alpha.- neric). sulfo-.omega.-[[1-[(2-propen-1- 721.10068 Elemental mercury. yloxy)methyl]undecyl]oxy]-, ammonium 721.10069 Ether amine phosphonate (ge- salt (1:1); Poly(oxy-1,2-ethanediyl), neric). .alpha.-sulfo-.omega.-[[1-[(2-propen-1- 721.10070 1,3-Butanediol, 3-methyl-. yloxy)methyl]tridecyl]oxy]-, ammonium 721.10071 9H-Thioxanthenium, 10-[1,1′- salt (1:1). biphenyl]-4-yl-2-(1-methylethyl)-9-oxo-, 721.10093 Alkylamides, ethoxylated (ge- hexafluorophosphate (1-) (1:1). neric). 721.10072 Benzene, 1,1′-methylenebis[4- 721.10094 Decene, branched and linear. isocyanato-, polymer with 721.10095 Oxetane, 3,3′-[oxybis(methylene)] benzenedicarboxylic acid, butyl dialkyl bis[3-ethyl-. ester, poly[oxy(methyl-1,2-ethanediyl)], 721.10096 Benzene, 1,4-bis (methoxymethyl)-. .alpha.-hydro-.omega.-hydroxy-, oxirane, 721.10097 Disubstituted benzenesulfonic alkyl-, polymer with oxirane, ether with acid, alkali metal salt (generic). propanepolyol and Sartomer’s HLBH P- 721.10098 Disubstituted benzoic acid, alkali 3000 and Lexorez 1180 (generic). metal salt (generic).

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721.10099 Dialkyl dimethyl ammonium car- 721.10126 Alkyl amino substituted triazine bonate (generic). amino substituted benezenesulfonic acid 721.10100 Dialkyl dimethyl ammonium car- reaction product with bonate (2:1) (generic). naphthalenesulfonato azo substituted 721.10101 Copolymer of alkyl acrylate and phenyl azo substituted benzenesulfonic ethyleneglycol dimethacrylate (generic). acid copper compound (generic). 721.10102 Diphosphoric acid, compd. with pi- 721.10127 Alkenyl dimethyl betaine (ge- perazine (1:1). neric). 721.10103 Naphtha (Fischer-Tropsch), C4-11- 721.10128 Modified imidazole (generic). alkane, branched and linear. 721.10129 Alkylamine ethoxylated (generic). 721.10104 Halophosphate mixed metal com- 721.10130 Quino[2,3-b]acridine-7,14-dione, plex (generic). 5,12-dihydro-ar-[4-[[2- 721.10105 Polyfluoroalkylether (generic). (sulfooxy)ethyl]substituted]phenyl]-, 721.10106 Silica, monosodium salt (generic). [(ethenylsilylidyne)tris(oxy)] - modified. 721.10131 Isononanamide, N-(2-ethylhexyl)-. 721.10107 Naphthalenedisulfonic acid, 721.10132 Phosphoramidic acid, [amino-hydroxy-[(substituted)azo-sulfo- carbomonocyclic-, diphenylester (ge- naphthaleneyl]azo]-hydroxy-[(methoxy- neric). sulfophenyl)azo], metal salt (generic). 721.10133 2-Propenoic acid, 2-methyl, 2-hy- 721.10108 Naphthalenedisulfonic acid, droxyethyl ester, homopolymer. hydrozy-[[[(hydroxyl-disulfo- 721.10134 Formaldehyde, polymer with naphthaleneyl)azo]-alkyl(C=1-5)- dialkylphenylamine, dialkylphenol and (sulfoalkoxy)cyclic]azo]-substituted azo-, trimethylhexanediamine (generic). metal salt (generic). 721.10135 Phosphinic acid, P,P-diethyl-, zinc 721.10109 Hexanoic acid, 2-ethyl-, mixed salt (2:1). triesters with benzoic acid and 721.10136 2-Propenoic acid, 2-methyl-, 2-hy- trimethylolpropane. droxyethyl ester, reaction products with 721.10110 Hexanoic acid, 2-ethyl-, mixed hexakis(alkoxyalkyl)melamine (generic). diesters with benzoic acid and neopentlyl 721.10137 Halogenated phenoxy aromatic glycol. (generic). 721.10111 Hexanoic acid, 2-ethyl-, mixed 721.10138 3-Isoxazolecarboxylic acid, 4,5- diesters with benzoic acid and diethylene dihydro-5,5-diphenyl-, ethyl ester. glycol. 721.10139 Ethanone, 1-(1-chlorocyclopropyl)-. 721.10112 Ethanone, 2-chloro-1-(1- 721.10140 Phosphoric acid, tin (2+) salt (2:3). chlorocyclopropyl)-. 721.10141 Oils, ginger, zingiber purpureum. 721.10113 Thioether epoxy (generic). 721.10142 Oxabicycloalkane carboxylic acid 721.10114 Polyhydroxyaminoether salts (ge- alkanediyl ester (generic). neric). 721.10143 Amines, bis (C11-14-branched and 721.10115 1-Hexadecanaminium, N,N-dibutyl- linear alkyl). N-(2-hydroxyethyl)-, bromide (1:1). 721.10144 Modified thiocarbamate (generic). 721.10116 Blocked polymeric isocyanate (ge- 721.10145 Modified reaction products of neric). alkyl alcohol, halogenated alkane, sub- 721.10117 Heteromonocyclo-beta-(2,4- stituted epoxide, and amino compound dichlorophenyl) -1-propanol (generic). (generic). 721.10118 Substituted aryl acetonitrile (ge- 721.10146 Partially fluorinated condensation neric). polymer (generic). 721.10119 Siloxane modified silica nanopar- 721.10147 Acrylate derivative of ticles (generic). alkoxysilylalkane ester and mixed metal 721.10120 Siloxane modified alumina nano- oxides (generic). particles (generic). 721.10148 Acryloxy alkanoic alkane deriva- 721.10121 Poly[oxy(methyl-1,2-ethanediyl)], tive with mixed metal oxides (generic). .alpha.-methyl-.omega.-(4- 721.10149 Carbon black, (3-methylphenyl)- nonylphenoxy)-, branched. modified, substituted (generic). 721.10122 2-Propenoic acid, 2-methyl-, 1,1′-[2- 721.10150 Carbon black, (4-methylphenyl)- ethyl-2-[[(2-methyl-1-oxo-2-propen-1- modified, substituted (generic). yl)oxy]methyl]- 1,3-propanediyl] ester, 721.10151 Modified styrene, divinylbenzene polymer with 1,3-butadiene, polymer (generic). ethenylbenzene and 2-hydroxyethyl 2- 721.10152 Oxirane, substituted silylmethyl-, methyl-2-propenoate. hydrolysis products with alkanol zir- 721.10123 [1,2,4-Triazolo[1,5-a]pyrimidin-2- conium(4+) salt and silica, acetates (ge- amine, 5,7-dimethoxy-]. neric). 721.10124 Brominated polyaromatic com- 721.10153 Modified methyl methacrylate, 2- pound (generic). hydroxyethyl methacrylate polymer (ge- 721.10125 Alkenedioic acid, dialkyl ester, re- neric). action products with 721.10154 Quaternary ammonium com- polyaminocarbomonocycle and alkenoic pounds, dicoco alkyldimethyl, chlorides, acid alkyl ester (generic). reaction products with silica.

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721.10155 Multi-walled carbon nanotubes 721.10186 Ethylhexyl oxetane (generic). (generic). 721.10187 4-Morpholinepropanamine, N-(1,3- 721.10156 Single-walled carbon nanotubes dimethylbutylidene)-. (generic). 721.10188 Fatty acids, tall-oil, reaction prod- 721.10157 Benzeneethanol,halo- ucts with 4-methyl-2-pentanone and ali- ,halocycloalkyl-,hydrazinealkyl- (ge- phatic polyamine (generic). neric). 721.10189 Fatty acids, tall-oil, reaction prod- 721.10158 2-Pentanone, 3,5-dichloro-. ucts with (butoxymethyl) oxirane form- 721.10159 1-Docosanamine, N,N-dimethyl-. aldehyde-phenol polymer glycidyl ether, 721.10160 Poly(oxy-1,2-ethanediyl), .alpha.- morpholinepropanamine, propylene gly- [(13Z)-1-oxo-13-docosen-1-yl]-.omega.- col diamine and aliphatic polyamine, N- [[(13Z)-1-oxo-13-docosen-1-yl]oxy]-. (1,3 -dimethylbutylidene) derivs (ge- 721.10161 Substituted silyl methacrylate neric). (generic). 721.10190 Formaldehyde, polymer with ali- 721.10162 1,3 Dioxolane-4-butanol, 2-ethenyl-. phatic diamine and phenol, reaction 721.10163 Chloro fluoro alkane (generic). products with 4-methyl-2-pentanone (ge- 721.10164 Benzenecarboximidamide, N-hy- neric). droxy-4-nitro-. 721.10191 Amides, coco, N-[3- 721.10165 Carbonotrithioic acid, (dibutylamino)propyl]. bis(phenylmethyl) ester. 721.10192 Amides, coco, N-[3- 721.10166 1,3-Cyclohexanedione, 2-[2-chloro- (dibutylamino)propyl], acrylates. 4-(methylsulfonyl)-3-[(2,2,2- 721.10193 1-Butanaminium, N-(3- trifluoroethoxy)methyl]benzoyl]-, ion(1-), aminopropyl)-N-butyl-N-(2- potassium salt (1:1). carboxyethyl)-, N-coco acyl derivs., inner 721.10167 Tetrafluoro nitrotoluene (generic). salts. 721.10168 Cesium tungsten oxide. 721.10194 Dialkylcocoamidoalkylpropionate 721.10169 Cyclopentane, methoxy-. (generic). 721.10170 Polyoxyethylene 721.10195 Dialkylcornoilamidoalkylamine polyalkylarylphenylether sulfate ammo- (generic). nium salt (generic). 721.10196 Dialkylcornoilamidoacrylate (ge- 721.10171 1H-benz(e)indolium, 1,1,2,3- neric). tetramethyl-, 4-methylbenzenesulfonic 721.10197 Dialkycornoilamidoalkylbetaine acid (1:1). (generic). 721.10172 Alkylamide derivative (generic). 721.10198 Dialkylcornoilamidopropionate 721.10173 Silanamine,1,1,1-triethoxy-N,N- (generic). diethyl-. 721.10199 Substituted aliphatic amine (ge- 721.10174 1-Propanaminium, 3-amino-N- neric). (carboxymethyl)-N,N-dimethyl-, N-pea- 721.10200 Benzenacetonitrile, nut-oil acyl derivs., inner salts. cyclohexylidene-alkyl substituted (ge- 721.10175 1-Propanaminium, N-(3- neric). aminopropyl)-2-hydroxy-N,N-dimethyl-3- 721.10202 Benzoic acid, 4-chloro-2- [(sub- sulfo-, N-(C12-18 and C18-unsatd. acyl) stituted)azo]-, strontium salt (1:1) (ge- derivs., inner salts. neric). 721.10176 Amides, peanut-oil, N-[3- 721.10203 Phosphonium, tetrabutyl-, hydrox- (dimethylamino)propyl]. ide (1:1). 721.10177 Phosphoric acid, yttrium(3+) salt 721.10204 Aryloxyacrylate (generic). (1:1). 721.10205 Formaldehyde, polymer with 1,3- 721.10178 Distillates (Fischer-Tropsch), benzenediol and 1,1′- hydroisomerized middle, C10-13-branched methylenebis[isocyanatobenzene]. alkane fraction. 721.10206 4-Cyclohexene-1,2-dicarboxylic 721.10179 Copolymers of phenol and aro- acid, 1,2-bis(2-oxiranylmethyl) ester. matic hydocarbon (generic). 721.10207 1,3-Cyclohexanedimethanamine, 721.10180 Trifunctional acrylic ester (ge- N1,N3-bis(2-methylpropylidene)-. neric). 721.10208 Amines, di-C11-14-isoalkyl, C13- 721.10181 Halide salt of an alkylamine (ge- rich. neric). 721.10209 Epoxy terminated, hydrolyzed 721.10182 1-Propene, 2,3,3,3-tetrafluoro-. trialkoxysilane and glycidyl ether of 721.10183 Multi-walled carbon nanotubes phenol-formaldehyde resin (generic). (generic). 721.10210 Soybean oil, epoxidized, reaction 721.10184 Aliphatic triamine (generic). products with diethanolamine. 721.10185 1,2-Propanediol, 3-(diethylamino)-, 721.10211 Octadecanoic acid, reaction prod- polymers with 5-isocyanato-1- ucts with diethylenetriamine and urea, (isocyanatomethyl)-1,3,3- acetates. trimethylcyclohexane, propylene glycol 721.10212 1,2-Ethanediol, reaction products and reduced Me esters of reduced polymd. with epichlorohydrin. oxidized tetrafluoroethylene, 2-ethyl-1- 721.10213 Polyether polyester copolymer hexanol-blocked, acetates (salts). phosphate (generic).

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721.10214 Poly(oxyalkylenediyl),.alpha.-sub- (b) This subpart A contains provi- stituted carbomonocycle-.omega.-sub- sions governing submission and review stituted carbomonocycle (generic). of notices for the chemical substances 721.10215 Benzenepropanol, .beta.-methyl-. and significant new uses identified in 721.10216 2-Propenoic acid, 3-(5,5,6- subpart E of this part. The provisions trimethylbicyclo[2.2.1]hept-2- yl)cyclohexyl ester]. of this subpart A apply to the chemical 721.10217 Branched and linear alcohols (ge- substances and significant new uses neric). identified in subpart E of this part, ex- 721.10218 2-Propenoic acid, 2-mehtyl-, C12-15- cept to the extent that they are specifi- branched and linear alkyl esters, cally modified or supplanted by spe- telomers with alkyl 2- cific requirements in subpart E of this [[(alkylthio)thioxomethyl]thio]-2- part. In the event of a conflict between alkanoate, aminoalkyl methacrylate and the provisions of this subpart A and the alkyl methacrylate, tert-Bu 2- provisions of subpart E of this part, the ethylhexanoperoxoate-initiated (ge- provisions of subpart E of this part neric). 721.10219 Butanamide,N-[substituted shall govern. phenyl]-[(alkoxynitrophenyl)diazenyl]-3- (c) The provisions of part 720 of this oxo- (generic). chapter apply to this part 721. For pur- 721.10220 Phosphoric acid, polymer with poses of this part 721, wherever the cycloaliphatic diglycidyl ether, phrase ‘‘new chemical substance’’ ap- alkylethers (generic). pears in part 720 of this chapter, it 721.10221 3-Nonen-1-ol, 1-acetate, (3Z)-. shall mean the chemical substance sub- 721.10222 Styrenyl surface treated man- ject to this part 721. In the event of a ganese ferrite (generic). conflict between the provisions of part 721.10223 Styrenyl surface treated man- 720 of this chapter and the provisions of ganese ferrite with acrylic ester polymer (generic). this part 721, the provisions of this part 721.10224 Diglycidylaniline (generic). 721 shall govern. 721.10225 Quino[2,3-b] acridine-7,14-dione, [53 FR 28358, July 27, 1988, as amended at 62 2,9-dichloro-5,12-dihydro [4-[[2-(sulfooxy) FR 17932, Apr. 11, 1997] ethyl] substituted] phenyl]-, sodium salt (1:1) (generic). § 721.3 Definitions. AUTHORITY: 15 U.S.C. 2604, 2607, and 2625(c). The definitions in section 3 of the Act, 15 U.S.C. 2602, and § 720.3 of this Subpart A—General Provisions chapter apply to this part. In addition, the following definitions apply to this § 721.1 Scope and applicability. part: (a) This part identifies uses of chem- Acutely toxic effects A chemical sub- ical substances, except for microorga- stance produces acutely toxic effects if nisms regulated under part 725 of this it kills within a short time period (usu- chapter, which EPA has determined are ally 14 days): significant new uses under the author- (1) At least 50 percent of the exposed ity of section 5(a)(2) of the Toxic Sub- mammalian test animals following oral stances Control Act. In addition, it administration of a single dose of the specifies procedures for manufacturers, test substance at 25 milligrams or less importers, and processors to report on per kilogram of body weight (LD50). those significant new uses. This sub- (2) At least 50 percent of the exposed part A contains general provisions ap- mammalian test animals following der- plicable to this part. subpart B of this mal administration of a single dose of part identifies generic requirements for the test substance at 50 milligrams or certain significant new uses cross ref- less per kilogram of body weight erenced in specific provisions of sub- (LD50). part E of this part. subpart C of this (3) At least 50 percent of the exposed part identifies generic reporting re- mammalian test animals following ad- quirements for certain significant new ministration of the test substance for 8 uses cross referenced in specific provi- hours or less by continuous inhalation sions of subpart E of this part. subpart at a steady concentration in air at 0.5 E of this part identifies chemical sub- milligrams or less per liter of air stances and their significant new uses. (LC50). 171

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CAS Number means Chemical Ab- delegated by the Office Director to stracts Service Registry Number as- carry out the Office Director’s func- signed to a chemical substance on the tions under this part. Inventory. Employer means any manufacturer, Chemical name means the scientific importer, processor, or user of chem- designation of a chemical substance in ical substances or mixtures. accordance with the nomenclature sys- Environmentally transformed A chem- tem developed by the International ical substance is ‘‘environmentally Union of Pure and Applied Chemistry transformed’’ when its chemical struc- or the Chemical Abstracts Service’s ture changes as a result of the action rules of nomenclature, or a name which of environmental processes on it. will clearly identify a chemical sub- Facility means all buildings, equip- stance for the purpose of conducting a ment, structures, and other stationary hazard evaluation. items which are located on a single site Chemical protective clothing means or on contiguous or adjacent sites and items of clothing that provide a protec- which are owned or operated by the tive barrier to prevent dermal contact same person (or by any person which with chemical substances of concern. controls, is controlled by, or under Examples can include, but are not lim- common control with such person). ited to: full body protective clothing, Identity means any chemical or com- boots, coveralls, gloves, jackets, and mon name used to identify a chemical pants. substance or a mixture containing that Commercial use means the use of a substance. chemical substance or any mixture Immediate use A chemical substance containing the chemical substance in a is for the ‘‘immediate use’’ of a person commercial enterprise providing sale- if it is under the control of, and used able goods or a service to consumers only by, the person who transferred it (e.g., a commercial dry cleaning estab- from a labeled container and will only lishment or painting contractor). be used by that person within the work Common name means any designation shift in which it is transferred from the or identification such as code name, labeled container. code number, trade name, brand name, Impervious Chemical protective cloth- or generic chemical name used to iden- ing is ‘‘impervious’’ to a chemical sub- tify a chemical substance other than stance if the substance causes no chem- by its chemical name. ical or mechanical degradation, perme- Consumer means a private individual ation, or penetration of the chemical who uses a chemical substance or any protective clothing under the condi- product containing the chemical sub- tions of, and the duration of, exposure. stance in or around a permanent or Manufacturing stream means all rea- temporary household or residence, dur- sonably anticipated transfer, flow, or ing recreation, or for any personal use disposal of a chemical substance, re- or enjoyment. gardless of physical state or concentra- Consumer product means a chemical tion, through all intended operations of substance that is directly, or as part of manufacture, including the cleaning of a mixture, sold or made available to equipment. consumers for their use in or around a Metalworking fluid means a liquid of permanent or temporary household or any viscosity or color containing in- residence, in or around a school, or in tentionally added water and used in recreation. metal machining operations for the Customer means any person to whom purpose of cooling, lubricating, or rust a manufacturer, importer, or processor inhibition. distributes any quantity of a chemical MSDS means material safety data substance, or of a mixture containing sheet, the written listing of data for the chemical substance, whether or not the chemical substance as required a sale is involved. under § 721.72(c). Director of the Office of Pollution Pre- NIOSH means the National Institute vention and Toxics means the Director for Occupational Safety and Health of of the EPA Office of Pollution Preven- the U.S. Department of Health and tion and Toxics or any EPA employee Human Services.

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Non-enclosed process means any equip- must be performed at sites under the ment system (such as an open-top reac- control of the processor; distribution in tor, storage tank, or mixing vessel) in commerce is limited to purposes of ex- which a chemical substance is manu- port; and the processor may not use the factured, processed, or otherwise used chemical substance except in small where significant direct contact of the quantities solely for research and de- bulk chemical substance and the work- velopment. place air may occur. Process stream means all reasonably Non-industrial use means use other anticipated transfer, flow, or disposal than at a facility where chemical sub- of a chemical substance, regardless of stances or mixtures are manufactured, physical state or concentration, imported, or processed. through all intended operations of Personal protective equipment means processing, including the cleaning of any chemical protective clothing or de- equipment. vice placed on the body to prevent con- Recipient means any person who pur- tact with, and exposure to, an identi- chases or otherwise obtains a chemical fied chemical substance or substances substance directly from a person who in the work area. Examples include, manufacturers, imports, or processes but are not limited to, chemical pro- the substance. tective clothing, aprons, hoods, chem- Serious acute effects means human in- ical goggles, face splash shields, or jury or human disease processes that equivalent eye protection, and various have a short latency period for develop- types of respirators. Barrier creams are ment, result from short-term exposure not included in this definition. to a chemical substance, or are a com- Powder or dry solid form means a state bination of these factors and which are where all or part of the substance likely to result in death or severe or would have the potential to become prolonged incapacitation. fine, loose, solid particles. Principal importer means the first im- Serious chronic effects means human porter who, knowing that a chemical injury or human disease processes that substance will be imported for a sig- have a long latency period for develop- nificant new use rather than manufac- ment, result from long-term exposure tured in the United States, specifies to a chemical substance, or are a com- the chemical substance and the bination of these factors and which are amount to be imported. Only persons likely to result in death or severe or who are incorporated, licensed, or prolonged incapacitation. doing business in the United States Short-term test indicative of carcino- may be principal importers. genic potential means either any limited Process for commercial purposes means bioassay that measures tumor or the preparation of a chemical sub- preneoplastic induction, or any test instance or mixture containing the dicative of interaction of a chemical chemical substance, after manufacture substance with DNA (i.e., positive re- of the substance, for distribution in sponse in assays for gene mutation, commerce with the purpose of obtain- chromosomal aberrations, DNA dam- ing an immediate or eventual commer- age and repair, or cellular trans- cial advantage for the processor. Proc- formation). essing of any amount of a chemical Short-term test indicative of the poten- substance or mixture containing the tial to cause a developmentally toxic effect chemical substance is included in this means either any in vivo preliminary definition. If a chemical substance or development toxicity screen conducted mixture containing impurities is proc- in a mammalian species, or any in vitro essed for commercial purposes, the im- developmental toxicity screen, includ- purities also are processed for commer- ing any test system other than the in- cial purposes. tact pregnant mammal, that has been Process solely for export means to extensively evaluated and judged reli- process for commercial purposes solely able for its ability to predict the poten- for export from the United States tial to cause developmentally toxic ef- under the following restrictions on ac- fects in intact systems across a broad tivity in the United States: Processing range of chemicals or within a class of

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chemicals that includes the substance or used and where employees are of concern. present. Significant adverse environmental ef- Workplace means an establishment at fects means injury to the environment one geographic location containing one by a chemical substance which reduces or more work areas. or adversely affects the productivity, [53 FR 28358, July 27, 1988, as amended at 54 utility, value, or function of biological, FR 31306, July 27, 1989; 58 FR 63516, Dec. 1, commercial, or agricultural resources, 1993] or which may adversely affect a threatened or endangered species. A sub- § 721.5 Persons who must report. stance will be considered to have the (a) The following persons must sub- potential for significant adverse envi- mit a significant new use notice as ronmental effects if it has one of the specified under the provisions of sec- following: tion 5(a)(1)(B) of the Act, part 720 of (1) An acute aquatic EC50 of 1 mg/L or this chapter, and § 721.25: less. (1) A person who intends to manufac-

(2) An acute aquatic EC50 of 20 mg/L ture, import, or process for commercial or less where the ratio of aquatic purposes a chemical substance identi- vertebrate 24-hour to 48-hour EC50 is fied in a specific section in subpart E of greater than or equal to 2.0. this part, and intends to engage in a (3) A Maximum Acceptable Toxicant significant new use of the substance Concentration (MATC) of less than or identified in that section. equal to 100 parts per billion (100 ppb). (2) A person who intends to manufacture, import, or process for commercial (4) An acute aquatic EC50 of 20 mg/L or less coupled with either a measured purposes a chemical substance identi- bioconcentration factor (BCF) equal to fied in a specific section in subpart E of or greater than 1,000x or in the absence this part, and intends to distribute the of bioconcentration data a log P value substance in commerce. A person de- equal to or greater than 4.3. scribed in this paragraph is not required to submit a significant new use Site means a contiguous property notice if that person can document one unit. Property divided only by a public or more of the following as to each re- right-of-way is one site. There may be cipient of the substance from that per- more than one manufacturing plant on son: a single site. (i) That the person has notified the Site-limited intermediate means an in- recipient, in writing, of the specific termediate manufactured, processed, section in subpart E of this part which and used only within a site and not dis- identifies the substance and its des- tributed in commerce other than as an ignated significant new uses. impurity or for disposal. Imported (ii) That the recipient has knowledge intermediates cannot be ‘‘site-lim- of the specific section in subpart E of ited.’’ this part which identifies the substance Spray application means any method and its designated significant new uses. of projecting a jet of vapor of finely di- (iii) That the recipient cannot under- vided liquid onto a surface to be coat- take any significant new use described ed; whether by compressed air, hydrau- in the specific section in subpart E of lic pressure, electrostatic forces, or this part. other methods of generating a spray. (b) A person described in paragraph Use stream means all reasonably an- (a)(2) of this section must submit a sig- ticipated transfer, flow, or disposal of a nificant new use notice if that person chemical substance, regardless of phys- has knowledge at the time of commer- ical state or concentration, through all cial distribution of the substance iden- intended operations of industrial, com- tified in the specific section in subpart mercial, or consumer use. E of this part that a recipient intends Waters of the United States has the to engage in a designated significant meaning set forth in 40 CFR 122.2. new use of that substance without sub- Work area means a room or defined mitting a notice under this part. space in a workplace where a chemical (c) A person who processes a chem- substance is manufactured, processed, ical substance identified in a specific

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section in subpart E of this part for a (2) If EPA notifies the manufacturer, significant new use of that substance is importer, or processor that the recipi- not required to submit a significant ent is engaging in a significant new use new use notice if that person can docu- after providing the statement of assur- ment each of the following: ance described in paragraph (d)(1)(ii) of (1) That the person does not know the this section and without submitting a specific chemical identity of the chem- notice under this part, the manufac- ical substance being processed. turer, importer, or processor shall im- (2) That the person is processing the mediately cease distribution to that re- chemical substance without knowledge cipient until the manufacturer, im- that the substance is identified in sub- porter, or processor or the recipient part E of this part. has submitted a significant new use no- (d)(1) If at any time after com- tice under this part and the notice re- mencing distribution in commerce of a view period has ended. chemical substance identified in a spe- (3) If, after receiving a statement of cific section in subpart E of this part a assurance from a recipient under para- person described in paragraph (a)(2) of graph (d)(1)(ii) of this section, a manu- this section has knowledge that a re- facturer, importer, or processor has cipient of the substance is engaging in knowledge that the recipient is engag- a significant new use of that substance ing in a significant new use without designated in that section without sub- submitting a notice under this part, mitting a notice under this part, the the manufacturer, importer, or proc- person is required to cease supplying essor must immediately cease distrib- the chemical substance to that recipi- uting the substance to that recipient ent and to submit a significant new use and notify EPA enforcement authori- notice for that chemical substance and ties at the address identified in para- significant new use, unless the person graph (d)(1)(iii) of this section. The is able to document each of the fol- manufacturer, importer, or processor lowing: may not resume distribution to that (i) That the person has notified the recipient until any one of the following recipient and EPA enforcement au- has occurred: thorities (at the address in paragraph (i) The manufacturer, importer, or (d)(1)(iii) of this section), in writing processor has submitted a significant within 15 working days of the time the new use notice under this part and the person develops knowledge that the re- notice review period has ended. cipient is engaging in a significant new (ii) The recipient has submitted a sig- use, that the recipient is engaging in a nificant new use notice under this part significant new use without submitting and the notice review period has ended. a significant new use notice. (iii) The manufacturer, importer, or (ii) That, within 15 working days of processor has received notice from EPA notifying the recipient as described in enforcement authorities that it may paragraph (d)(1)(i) of this section, the resume distribution to that recipient. person received from the recipient, in (e) Any significant new use notice re- writing, a statement of assurance that lating to import of a substance must be the recipient is aware of the terms of submitted by the principal importer. the applicable section in subpart E of [53 FR 28359, July 27, 1988, as amended at 60 this part and will not engage in the sig- FR 34464, July 3, 1995] nificant new use. (iii) That the person has promptly § 721.11 Applicability determination provided EPA enforcement authorities when the specific chemical identity with a copy of the recepient’s state- is confidential. ment of assurance described in para- (a) A person who intends to manufac- graph (d)(1)(ii) of this section. The copy ture, import, or process a chemical must be sent to the Office of Enforce- substance which is described by a ge- ment and Compliance Assurance, Office neric chemical name is subpart E of of Compliance (2224A), U.S. Environ- this part may ask EPA whether the mental Protection Agency, Ariel Rios, substance is subject to the require- 1200 Pennsylvania Ave., N.W., Wash- ments of this part. EPA will answer ington, DC, 20044. such an inquiry only if EPA determines

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that the person has a bona fide intent substance under § 710.7(e)(2)(v) of this to manufacture, import, or process the chapter or the information requested chemical substance for commercial under § 720.85(b)(3)(iii) of this chapter. purposes. (e) If the manufacturer, importer, or (b) To establish a bona fide intent to processor has shown a bona fide intent manufacture, import, or process a to manufacture, import, or process the chemical substance, the person who in- substance and has provided sufficient tends to manufacture, import, or proc- unambiguous chemical identity infor- ess the chemical substance must sub- mation to enable EPA to make a con- mit the following information in writ- clusive determination as to the iden- ing to the Document Control Office tity of the substance, EPA will inform (DCO) (7407M), Office of Pollution Pre- the manufacturer, importer, or proc- vention and Toxics (OPPT), Environ- essor whether the chemical substance mental Protection Agency, 1200 Penn- is subject to this part and, if so, which sylvania Ave., NW., Washington, DC section in subpart E of this part ap- 20460–0001, ATTN: SNUR Bonafide sub- plies. missions. (f) A disclosure to a person with a (1) The specific chemical identity of bona fide intent to manufacture, im- the chemical substance that the person port, or process a particular chemical intends to manufacture, import, or substance that the substance is subject process. to this part will not be considered pub- (2) A signed statement that the per- lic disclosure of confidential business son intends to manufacture, import, or information under section 14 of the process the chemical substance for Act. commercial purposes. (g) EPA will answer an inquiry on (3) A description of the research and whether a particular chemical sub- development activities conducted to stance is subject to this part within 30 date, and the purpose for which the days after receipt of a complete sub- person will manufacture, import, or mission under paragraph (b) of this sec- process the chemical substance. tion. (4) An elemental analysis. (5) Either an X-ray diffraction pat- [53 FR 28359, July 27, 1988, as amended at 60 FR 34464, July 3, 1995; 71 FR 33641, June 12, tern (for inorganic substances), a mass 2006] spectrum (for most other substances), or an infrared spectrum of the par- § 721.20 Exports and imports. ticular chemical substance, or, if such Persons who intend to export a chem- data do not resolve uncertainties with ical substance identified in subpart E respect to the identity of the chemical of this part, or in any proposed rule substance, additional or alternative which would amend subpart E of this spectra or other data to identify the part, are subject to the export notifica- substance. tion provisions of section 12(b) of the (c) If an importer or processor cannot Act. The regulations that interpret provide all the information required in section 12(b) appear at 40 CFR part 707. paragraph (b) of this section because it Persons who import a substance identi- is claimed as confidential business in- fied in a specific section in subpart E of formation by the importer’s or proc- this part are subject to the import cer- essor’s manufacturer or supplier, the tification requirements under section manufacturer or supplier may supply 13 of the Act, which are codified at 19 the information directly to EPA. CFR 12.118 through 12.127 and 127.28. (d) EPA will review the information The EPA policy in support of the im- submitted by the manufacturer, import certification requirements appears porter, or processor under paragraph at 40 CFR part 707. (b) of this section to determine whether than person has shown a bona fide in- [53 FR 28360, July 27, 1988] tent to manufacture, import, or process the chemical substance. If nec- § 721.25 Notice requirements and pro- essary, EPA will compare this informa- cedures. tion either to the information re- (a) Each person who is required to quested for the confidential chemical submit a significant new use notice

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under this part must submit the notice control worker exposure or environ- at least 90 calendar days before com- mental release which EPA has deter- mencing manufacture, import, or proc- mined provide substantially the same essing of a chemical substance identi- degree of protection as the specified fied in subpart E of this part for a sig- control measures. Persons who manu- nificant new use. The submitter must facture, import, or process a chemical comply with any applicable require- substance identified in such sections ment of section 5(b) of the Act, and the and who intend to employ alternative notice must include the information measures to control worker exposure and test data specified in section 5(d)(1) or environmental release must submit of the Act. The notice must be sub- a request to EPA for a determination mitted on EPA Form 7710–25, and must of equivalency before commencing comply with the requirements of part manufacture, import, or processing in- 720 of this chapter, except to the extent volving the alternative control meas- that they are inconsistent with this ures. part 721. (b) Persons submitting a request for (b) If two or more persons are re- a determination of equivalency to EPA quired to submit a significant new use under this part, unless allowed by 40 notice for the same chemical substance CFR 720.40(a)(2)(i), (ii), or (iii), must and significant new use identified in submit the request to EPA via EPA’s subpart E of this part, they may sub- Central Data Exchange (CDX) using mit a joint notice to EPA. Persons sub- EPA-provided e-PMN software in the mitting a joint notice must individ- manner set forth in 40 CFR 720.40(a)(2). ually complete the certification sec- See 40 CFR 720.40(a)(2)(iv) for information of part I of the required notification on how to obtain e-PMN software. tion form. Persons who are required to Support documents related to these resubmit individually, but elect to sub- quests must be submitted in the man- mit jointly, remain individually liable ner set forth in 40 CFR 720.40(a)(2)(i), for the failure to submit required infor- (ii), or (iii). If submitted by paper, re- mation which is known to or reason- quests must be submitted either via ably ascertainable by them and test U.S. mail to the Document Control Of- data in their possession or control. fice (DCO) (7407M), Office of Pollution (c) EPA will process the notice in ac- Prevention and Toxics, Environmental cordance with the procedures of part Protection Agency, 1200 Pennsylvania 720 of this chapter, except to the extent Ave., NW., Washington, DC 20460–0001; they are inconsistent with this part. ATTN: SNUR Equivalency Determina- (d) Any person submitting a signifi- tion or submitted via courier to the cant new use notice in response to the Environmental Protection Agency, requirements of this part 721 shall not OPPT Document Control Office (DCO), manufacture, import, or process a EPA East Bldg., 1201 Constitution Ave., chemical substance identified in sub- NW., Rm. 6428, Washington, DC 20004; part E of this part for a significant new ATTN: SNUR Equivalency Determina- use until the notice review period, in- tion. Optical discs containing elec- cluding all extensions and suspensions, tronic requests must be submitted by has expired. courier to the Environmental Protec- [53 FR 28360, July 27, 1988, as amended at 60 tion Agency, OPPT Document Control FR 16311, Mar. 29, 1995; 75 FR 787, Jan. 6, 2010] Office (DCO), EPA East Bldg., 1201 Con- stitution Ave., NW., Rm. 6428, Wash- § 721.30 EPA approval of alternative ington, DC 20004; ATTN: SNUR Equiva- control measures. lency Determination. A request for a (a) In certain sections of subpart E of determination of equivalency must this part, significant new uses for the contain: identified substances are described as (1) The name of the submitter. the failure to establish and implement (2) The specific chemical identity of programs providing for the use of ei- the substance. ther: specific measures to control (3) The citation for the specific sec- worker exposure to or release of sub- tion in subpart E of this part which stances which are identified in such pertains to the substance for which the sections, or alternative measures to request is being submitted.

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(4) A detailed description of the ac- (b) Using for commercial purposes a tivities involved. chemical substance which a person (5) The specifications of the alter- knew or had reason to know was manu- native worker exposure control meas- factured, imported, or processed in vio- ures or environmental release control lation of this part is a violation of sec- measures. tion 15(2) of the Act (15 U.S.C. 2614). (6) An analysis justifying why such (c) Failure or refusal to permit ac- alternative control measures provide cess to or copying of records, as re- substantially the same degree of pro- quired by section 11 of the Act, is a vio- tection as the specific control meas- lation of section 15(3) of the Act (15 ures identified in the specific section in U.S.C. 2614). subpart E of this part which pertains to (d) Failure or refusal to permit entry the substance for which the request is or inspection, as required by section 11 being submitted. of the Act, is a violation of section (7) The data and information de- 15(4) of the Act. scribed in § 720.50 (a) and (b) of this (e) Violators of the Act or of this chapter unless such data and informa- part may be subject to the civil and tion have already been submitted to criminal penalties in section 16 of the the Office of Pollution Prevention and Act (15 U.S.C. 2615) for each violation. Toxics, EPA. The submission of false or misleading (c) Requests for determinations of information in connection with the re- equivalency will be reviewed by EPA quirement of any provision of this part within 45 days. Determinations under may subject persons to penalties cal- this paragraph will be made by the Di- culated as if they never filed a notice. rector, Office of Pollution Prevention (f) Under the authority of sections 7 and Toxics, or designee. Notice of the and 17 of the Act, EPA may: results of such determinations will be mailed to the submitter. (1) Seek to enjoin the manufacture, (d) If EPA notifies the submitter import, or processing of a chemical under paragraph (c) of this section that substance in violation of this part. EPA has determined that the alter- (2) Act to seize any chemical sub- native control measures provide substance which is being manufactured, stantially the same degree of protec- imported, or processed in violation of tion as the specified control measures this part. identified in the specified section of (3) Take any other appropriate ac- subpart E of this part which pertains to tion. the substance for which the request is [53 FR 28361, July 27, 1988] being submitted, the submitter may commence manufacture, import, or § 721.40 Recordkeeping. processing in accordance with the spec- Any person subject to the require- ifications for alternative worker expo- ments of this part must retain docu- sure control measures or environ- mentation of information contained in mental release control measures iden- that person’s significant new use notified in the submitter’s request, and tice. This documentation must be may alter any corresponding notifica- maintained for a period of 5 years from tion to workers to reflect such alter- the date of the submission of the sig- native controls. Deviations from the nificant new use notice. activities described in the EPA notification constitute a significant new use [53 FR 28361, July 27, 1988] and are subject to the requirements of this part. § 721.45 Exemptions. [53 FR 28360, July 27, 1988, as amended at 60 The persons identified in § 721.5 are FR 34464, July 3, 1995; 71 FR 33641, June 12, not subject to the notification require- 2006; 75 FR 787, Jan. 6, 2010] ments of § 721.25 for a chemical substance identified in subpart E of this § 721.35 Compliance and enforcement. part, unless otherwise specified in a (a) Failure to comply with any provi- specific section in subpart E, if: sion of this part is a violation of sec- (a) The person has applied for and has tion 15(1) of the Act (15 U.S.C. 2614). been granted an exemption for test

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marketing the substance for a signifi- ten notification of compliance only if cant new use identified in subpart E of one of the following occurs: this part in accordance with section (1) EPA is unable to make the finding 5(h)(1) of the Act and § 720.38 of this that the activities described in the sig- chapter. nificant new use notice will or may (b) The person manufactures, im- present an unreasonable risk of injury ports, or processes the substance for a to health or the environment under significant new use identified in sub- reasonably foreseeable circumstances. part E of this part in small quantities (2) EPA and the person negotiate a solely for research and development in consent order under section 5(e) of the accordance with § 721.47. Act, such order to take effect on the ef- (c) The person has applied for and fective date of the section in subpart E been granted an exemption under sec- of this part which identifies the sub- tion 5(h)(5) of the Act. stance. (d) The person manufactures, im- (i) The person is operating under the ports, or processes the substance only terms of a consent order issued under as an impurity. section 5(e) of the Act applicable to (e) The person manufactures, im- that person. If a provision of such sec- ports, or processes the substance only tion 5(e) order is inconsistent with a as a byproduct which is used only by specific significant new use identified public or private organizations that (1) in subpart E of this part, abiding by burn it as a fuel, (2) dispose of it as a the provision of the section 5(e) order waste, including in a landfill or for en- exempts the person from submitting a riching soil, or (3) extract component significant new use notice for that spe- chemical substances from it for com- cific significant new use. mercial purposes. (f) The person imports or processes [53 FR 28361, July 27, 1988] the substance as part of an article. § 721.47 Conditions for research and (g) The person manufactures or proc- development exemption. esses the substance solely for export and, when distributing the substance in (a) A person who manufactures, im- commerce, labels the substance in ac- ports, or processes a chemical sub- cordance with section 12(a)(1)(B) of the stance identifies in subpart E of this Act. part for a significant new use identified (h) The person submits a significant in subpart E of this part is not subject new use notice for the substance prior to the notification requirements of to the promulgation date of the section § 721.25 if the following conditions are in subpart E of this part which identi- met: fies the substance, and the person re- (1) The person manufactures, im- ceives written notification of compli- ports, or processes the substance for ance from EPA prior to the effective the significant new use in small quan- date of such section. The notice sub- tities solely for research and develop- mitter must comply with any applica- ment. ble requirement of section 5(b) of the (2) The manufacturer, importer, or Act. The notice must include the infor- processor notifies all persons in its em- mation and test data specified in sec- ploy or to whom it directly distributes tion 5(d)(1) of the Act and must be sub- the chemical substance, who are en- mitted on the notice form in Appendix gaged in experimentation, research, or A to part 720 of this chapter. For pur- analysis on the chemical substance, in- poses of this exemption, the specific cluding the manufacture, processing, section in subpart E of this part which use, transport, storage, and disposal of identifies the substance and §§ 721.1, the substance associated with research 721.3, 721.11, 721.35, and 721.40 apply; and development activities, of any risk after the effective date of the section to health, identified under paragraph in subpart E of this part which identi- (b) of this section, which may be asso- fies the substance, § 721.5 applies and ciated with the substance. The notifi- § 721.20 continues to apply. EPA will cation must be made in accordance provide the notice submitter with writ- with paragraph (c) of this section.

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(3) The chemical substance is used tem, conspicuous placement of notices by, or directly under the supervision in areas where exposure may occur, of, a technically qualified individual. written notification to each person po- (b)(1) To determine whether notifica- tentially exposed, or any other method tion under paragraph (a)(2) of this sec- of notification which adequately in- tion is required, the manufacturer, im- forms persons of health risks which the porter, or processor must review and manufacturer, importer, or processor evaluate the following information to has reason to believe may be associated determine whether there is reason to with the substance, as determined believe there is any risk to health under paragraph (b)(1) of this section. which may be associated with the (2) If the manufacturer, importer, or chemicals substance: processor distributes a chemical sub- (i) Information in its possession or stance manufactured, imported, or control concerning any significant ad- processed under this section to persons verse reaction by persons exposed to not in its employ, the manufacturer, the chemical substance which may rea- importer, or processor must in written sonably be associated with such expo- form: sure. (i) Notify those persons that the sub- (ii) Information provided to the man- stance is to be used only for research ufacturer, importer, or processor by a and development purposes. supplier or any other person con- (ii) Provide the notice of health risks cerning a health risk believed to be asspecified in paragraph (c)(1) of this sec- sociated with the substance. tion. (iii) Health and environmental ef- (3) The adequacy of any notification fects data in its possession or control under this section is the responsibility concerning the substance. of the manufacturer, importer, or proc- (iv) Information on health effects essor. which accompanies any EPA rule or (d) Quantities of the chemical sub- order issued under section 4, 5, or 6 of stance, or of mixtures or articles con- the Act that applies to the substance taining the chemical substance, re- and of which the manufacturer, im- maining after completion of research porter, or processor has knowledge. and development activities may be: (2) When the research and develop- (1) Disposed of as a waste in accord- ment activity is conducted solely in a ance with applicable Federal, State, laboratory and exposure to the chem- and local regulations, to the extent the ical substance is controlled through disposal activity is not identified as a the implementation of prudent labora- significant new use for the substance in tory practices for handling chemical subpart E of this part, or substances of unknown toxicity, and (2) Used for a commercial purpose, to any distribution, except for purposes of the extent the use is not identified as a disposal, is to other such laboratories significant new use of the substance in for further research and development subpart E of this part. activity, the information specified in (e)(1) Persons who manufacture, im- paragraph (b)(1) of this section need port, or process a chemical substance not be reviewed and evaluated. (For under this section must retain the fol- purposes of this paragraph (b)(2), a lab- lowing records: oratory is defined as a contained re- (i) Copies of or citations to informa- search facility where relatively small tion reviewed and evaluated under quantities of chemical substances are paragraph (b)(1) of this section to de- used on a pro-production basis, and termine the need to make any notifica- where activities involve the use of con- tion of risk. tainers for reactions, transfers, and (ii) Documentation of the nature and other handling of substances designed method of notification under paragraph to be easily manipulated by a single in- (c)(1) of this section including copies of dividual). any labels or written notices used. (c)(1) The manufacturer, importer, or (iii) Documentation of prudent lab- processor must notify the persons iden- oratory practices used instead of noti- tified in paragraph (a)(2) of this section fication and evaluation under para- by means of a container labeling sys- graph (b)(2) of this section.

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(iv) The names and addresses of any (i) Gloves. persons other than the manufacturer, (ii) Full body chemical protective importer, or processor to whom the clothing. substance is distributed, the identity of (iii) Chemical goggles or equivalent the substance, the amount distributed, eye protection. and copies of the notifications required (iv) Clothing which covers any other under paragraph (c)(2) of this section. exposed areas of the arms, legs, and (2) [Reserved] torso. Clothing provided under this paragraph need not be tested or evalu- [53 FR 28361, July 27, 1988, as amended at 58 FR 34204, June 23, 1993] ated under the requirements of paragraph (a)(3) of this section. (3) The employer is able to dem- Subpart B—Certain Significant onstrate that each item of chemical New Uses protective clothing, including gloves, selected provides an impervious barrier SOURCE: 54 FR 31308, July 27, 1989, unless to prevent dermal exposure during nor- otherwise noted. mal and expected duration and conditions of exposure within the work area § 721.50 Applicability. by any one or a combination of the fol- This subpart B identifies certain sig- lowing: nificant new uses of chemical sub- (i) Testing the material used to make stances identified in subpart E of this the chemical protective clothing and part. The provisions of this subpart B the construction of the clothing to es- apply only when referenced as applying tablish that the protective clothing to a chemical substance identified in will be impervious for the expected du- subpart E of this part. ration and conditions of exposure. The testing must subject the chemical pro- § 721.63 Protection in the workplace. tective clothing to the expected condi- (a) Whenever a substance is identi- tions of exposure, including the likely fied in subpart E of this part as being combinations of chemical substances subject to this section, a significant to which the clothing may be exposed new use of the substance is any manner in the work area. or method of manufacturing, import- (ii) Evaluating the specifications ing, or processing associated with any from the manufacturer or supplier of use of the substance without estab- the chemical protective clothing, or of lishing a program whereby: the material used in construction of (1) Each person who is reasonably the clothing, to establish that the likely to be dermally exposed in the chemical protective clothing will be work area to the chemical substance impervious to the chemical substance through direct handling of the sub- alone and in likely combination with stance or through contact with equip- other chemical substances in the work ment on which the substance may area. exist, or because the substance be- (4) Each person who is reasonably comes airborne in the form listed in likely to be exposed to the chemical paragraph (a)(6) of this section, and substance by inhalation in the work cited in subpart E of this part for the area in one or more of the forms listed chemical substance, is provided with, in paragraph (a)(6) of this section and and is required to wear, personal pro- cited in subpart E of this part for the tective equipment that provides a bar- chemical substance, is provided with, rier to prevent dermal exposure to the and is required to wear, at a minimum, substance in the specific work area a NIOSH- approved respirator from one where it is selected for use. Each such of the categories listed in paragraph item of personal protective equipment (a)(5) of this section, and the respirator must be selected and used in accord- is used in accordance with 29 CFR ance with 29 CFR 1910.132 and 1910.133. 1910.134 and 30 CFR part 11. (2) In addition to any other personal (5) The following NIOSH approved protective equipment selected in para- respirators meet the minimum require- graph (a)(1) of this section, the fol- ments for paragraph (a)(4) of this sec- lowing items are required: tion:

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(i) Category 19C Type C supplied-air (xiii) Category 23C powered air-puri- respirator operated in pressure demand fying respirator equipped with a tight- or other positive pressure mode and fitting facepiece and organic gas/vapor equipped with a full facepiece. cartridges. (ii) Category 19C Type C supplied-air (xiv) Category 23C powered air-puri- respirator operated in pressure demand fying respirator equipped with a loose- or continuous flow mode and equipped fitting hood or helmet and organic gas/ with a tight-fitting facepiece. vapor cartridges. (iii) Category 19C Type C supplied-air (xv) Category 23C air-purifying res- respirator operated in pressure demand pirator equipped with organic gas/ or continuous flow mode and equipped vapor cartridges, including disposable with a hood or helmet or tight-fitting respirators. facepiece. (6) When cited in subpart E of this (iv) Category 21C air-purifying res- part for a substance, the following air- pirator equipped with a full facepiece borne form(s) of the substance apply to and high efficiency particulate filters. paragraphs (a) (1) and (4) of this sec- (v) Category 21C powered air-puri- tion: fying respirator equipped with a tight- (i) Dust. fitting facepiece and high efficiency (ii) Mist. particulate filters. (iii) Fume. (iv) Smoke. (vi) Category 21C powered air-puri- (v) Vapor. fying respirator equipped with a loose- (vi) Gas. fitting hood or helmet and high effi- (b) If a substance identified in sub- ciency particulate filters. part E of this part is present in the (vii) Category 21C air-purifying res- work area only as a mixture, an em- pirator equipped with a high efficiency ployer is exempt from the provisions of particulate filter including disposable this section if the concentration of the respirators. substance in the mixture does not ex- (viii) Category 23C air-purifying res- ceed a concentration set in subpart E pirator equipped with a full facepiece of this part. The exemption does not and combination cartridges approved apply if the employer has reason to be- for paints, lacquers, and enamels. (Ap- lieve that during intended use or proc- proval label may preclude use for some essing in the work area, the substance paints, lacquers, or enamels.) in the mixture may be concentrated (ix) Category 23C powered air-puri- above the level set in subpart E of this fying respirator equipped with a tight- part. fitting facepiece and combination car- (c)(1) If at any time after com- tridges approved for paints, lacquers, mencing distribution in commerce of a and enamels. (Approval label may pre- chemical substance that is identified in clude use for some paints, lacquers, or subpart E of this part as subject to this enamels.) section, the person has knowledge that (x) Category 23C powered air-puri- a recipient of the substance is engaging fying respirator equipped with a loose- in an activity that is not consistent fitting hood or helmet and combination with the implementation of a program cartridges approved for paints, lac- specified in paragraph (a) of this sec- quers, and enamels. (Approval label tion, the person is considered to have may preclude use for some paints, lac- knowledge that the recipient is engag- quers, or enamels.) ing in a significant new use and is re- (xi) Category 23C air-purifying res- quired to follow the procedures in pirator equipped with combination car- § 721.5(d) unless the person is able to tridges approved for paints, lacquers, document the following: and enamels, including disposable res- (i) That the person has notified the pirators. (Approval label may preclude recipient in writing within 15 working use for some paints, lacquers, or enam- days of the time the person first has els.) knowledge that the recipient is engag- (xii) Category 23C air-purifying res- ing in an activity that is not con- pirator equipped with a full facepiece sistent with the implementation of a and organic gas/vapor cartridges. program specified in paragraph (a) of

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this section, and that the person has ing program established under the Oc- knowledge of the failure of implemen- cupational Health and Safety Adminis- tation. tration (OSHA) Hazard Communication (ii) That within 15 working days of Standard (29 CFR 1900.1200), to comply notifying the recipient that the recipi- with this paragraph provided that the ent is engaging in an activity that is existing hazard communication pro- not consistent with the implementa- gram satisfies the requirements of this tion of a program specified in para- paragraph. The written program shall graph (a) of this section the person has include the following: received from the recipient, in writing, (1) A list of each substance identified a statement of assurance that the rein subpart E of this part as subject to cipient has established the program re- this section known to be present in the quired under paragraph (a) of this sec- work area. The list must be maintained tion, and will take appropriate meas- in the work area and must use the ures to avoid activities that are incon- identity provided on the appropriate sistent with implementation of the MSDS for each substance required program required under paragraph (a) under paragraph (c) of this section. The of this section. list may be compiled for the workplace (2) If, after receiving a statement of or for individual work areas. assurance from a recipient under para- (2) The methods the employer will graph (c)(1)(ii) of this section, a manu- use to inform employees of the hazards facturer, importer, or processor has of non-routine tasks involving the sub- knowledge that the recipient is engag- stance, for example, the cleaning of re- ing in an activity that is not con- actor vessels, and the hazards associ- sistent with the implementation of the ated with the substance contained in program specified in paragraph (a) of unlabeled pipes in their work area. this section, that person is considered (3) The methods the employer will to have knowledge that the person is use to inform contractors of the pres- engaging in a significant new use and ence of the substance in the employer’s is required to follow the procedures in workplace and of the provisions of this § 721.5(d). part applicable to the substance if employees of the contractor work in the § 721.72 Hazard communication pro- employer’s workplace and are reason- gram. ably likely to be exposed to the sub- Whenever a substance is identified in stance while in the employer’s work- subpart E of this part as being subject place. to this section, a significant new use of (b) Labeling. (1) Each employer shall that substance is any manner or meth- ensure that each container of the sub- od of manufacture, import, or proc- stance in the workplace is labeled in essing associated with any use of that accordance with this paragraph (b)(1). substance without establishing a haz- (i) The label shall, at a minimum, ard communication program as de- contain the following information: scribed in this section. (A) A statement of health hazard(s) (a) Written hazard communication pro- and precautionary measure(s) for the gram. Each employer shall develop and substance, if any, identified in subpart implement a written hazard commu- E of this part or by the employer. nication program for the substance in (B) The identity by which the sub- each workplace. The written program stance may be commonly recognized. will, at a minimum, describe how the (C) A statement of environmental requirements of this section for labels, hazard(s) and precautionary measure(s) MSDSs, and other forms of warning for the substance, if any, identified in material will be satisfied. The em- subpart E of this part or by the employer must make the written hazard ployer. communication program available, (D) A statement of exposure and pre- upon request, to all employees, con- cautionary measure(s), if any, identi- tractor employees, and their des- fied in subpart E of this part or by the ignated representatives. The employer employer. may rely on an existing hazard commu- (ii) The employer may use signs, nication program, including an exist- placards, process sheets, batch tickets,

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operating procedures, or other such cupational Safety and Health Adminis- written materials in lieu of affixing la- tration (OSHA) Hazard Communication bels to individual stationary process Standard (29 CFR 1900.1200), the em- containers, as long as the alternative ployer may prescribe on the label, method identifies the containers to MSDS, or alternative form of warning, which it is applicable and conveys in- the measures to control worker expo- formation specified by paragraph sure or environmental release which (b)(1)(i) of this section. Any written the employer determines provide the materials must be readily accessible to greatest degree of protection. However, the employees in their work areas should these control measures differ throughout each work shift. from the applicable measures required (iii) The employer need not label under subpart E of this part, the em- portable containers into which the sub- ployer must seek a determination of stance is transferred from labeled con- equivalency for such alternative containers, and which are intended only trol measures pursuant to § 721.30 be- for the immediate use of the employee fore prescribing them under this para- who performs the transfer. graph. (iv) The employer shall not remove (c) Material safety data sheets. (1) Each or deface an existing label on incoming employer must obtain or develop a containers of the substance unless the MSDS for the substance. container is immediately relabeled (2) Each MSDS shall contain, at a with the information specified in para- minimum, the following information: graph (b)(1)(i) of this section. (i) The identity used on the container (2) Each employer shall ensure that label of the substance under this sec- each container of the substance leaving tion, and, if not claimed confidential, its workplace for distribution in com- the chemical and common name of the merce is labeled in accordance with substance. If the chemical and common this paragraph. name are claimed confidential, a ge- (i) The label shall, at a minimum, neric chemical name must be used. contain the following information: (ii) Physical and chemical character- (A) The information required under istics of the substance known to the paragraph (b)(1)(i) of this section. employer (such as vapor pressure, flash (B) The name and address of the man- point). ufacturer or a responsible party who (iii) The physical hazards of the sub- can provide additional information on stance known to the employer, includ- the substance for hazard evaluation ing the potential for fire, explosion, and any appropriate emergency proce- and reactivity. dures. (iv) The potential human and envi- (ii) The label shall not conflict with ronmental hazards as specified in sub- the requirements of the Hazardous Ma- part E of this part for the substance. terials Transportation Act (18 U.S.C. (v) Signs and symptoms of exposure, 1801 et. seq.) and regulations issued and any medical conditions which are under that Act by the Department of expected to be aggravated by exposure Transportation. to the substance known to the em- (3) The label, or alternative forms of ployer. warning, shall be legible and promi- (vi) The primary routes of exposure nently displayed. to the substance. (4) The label, or alternative forms of (vii) Precautionary measures to con- warning, shall be in English; however, trol worker exposure and/or environ- the information may be repeated in mental release identified in subpart E other languages. of this part for the substance, or alter- (5) If the label or alternative form of native control measures which EPA warning is to be applied to a mixture has determined under § 721.30 provide containing a substance identified in substantially the same degree of pro- subpart E of this part as subject to this tection as the identified control meas- section in combination with another ures. substance identified in subpart E of (viii) Any generally applicable pre- this part and/or a substance defined as cautions for safe handling and use of a ‘‘hazardous chemical’’ under the Oc- the substance which are known to the

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employer, including appropriate hygi- (7) The employer must maintain a enic practices, protective measures copy of the MSDS in its workplace, and during repair and maintenance of con- must ensure that it is readily acces- taminated equipment, and procedures sible during each work shift to employ- for response to spills and leaks. ees when they are in their work areas. (ix) Any generally applicable control (8) The MSDS may be kept in any measures which are known to the em- form, including as operating proce- ployer, such as appropriate engineering dures, and may be designed to cover controls, work practices, or personal groups of substances in a work area protective equipment. where it may be more appropriate to (x) Emergency first aid procedures address the potential hazards of a proc- known to the employer. ess rather than individual substances. (xi) The date of preparation of the However, in all cases, the required in- MSDS or of its last revision. formation must be provided for each (xii) The name, address, and tele- substance and must be readily acces- phone number of the individual pre- sible during each work shift to employ- paring or distributing the MSDS, or a ees when they are in their work areas. responsible party who can provide addi- (9) The MSDS must be printed in tional information on the substance for English; however, the information may hazard evaluation and any appropriate be repeated in other languages. emergency procedures. (d) Employee information and training. (3) If no relevant information is Each employer must ensure that em- found or known for any given category ployees are provided with information on the MSDS, the employer must mark and training on the substance identi- the MSDS to indicate that no applica- fied in subpart E of this part. This in- ble information was found. formation and training must be pro- (4) Where multiple mixtures con- vided at the time of each employee’s taining the substance have similar initial assignment to a work area con- compositions (i.e., the chemical ingre- taining the substance and whenever dients are essentially the same, but the the substance subject to this section is specific composition varies from mix- introduced into the employee’s work ture to mixture) and similar hazards, area for the first time. the employer may prepare one MSDS (1) Information provided to employ- to apply to all of these multiple mix- ees under this paragraph shall include: tures. (i) The requirements of this section. (5) If the employer becomes aware of (ii) Any operations in the work area any significant new information re- where the substance is present. garding the hazards of the substance or (iii) The location and availability of ways to protect against the hazards, the written hazard communication pro- this new information must be added to gram required under paragraph (a) of the MSDS within 3 months from the this section, including the list of sub- time the employer becomes aware of stances identified in subpart E of this the new information. If the substance part as subject to this section, and is not currently being manufactured, MSDSs required by paragraph (c) of imported, processed, or used in the em- this section. ployer’s workplace, the employer must (2) Training provided to employees add the new information to the MSDS shall include: before the substance is reintroduced (i) Methods and observations that into the workplace. may be used to detect the presence or (6) The employer must ensure that release of the substance in or from an persons receiving the substance from employee’s work area (such as moni- the employer are provided an appro- toring conducted by the employer, con- priate MSDS with their initial ship- tinuous monitoring devices, visual ap- ment and with the first shipment after pearance, or odor of the substance an MSDS is revised. The employer may when being released). either provide the MSDS with the (ii) The potential human health and shipped containers or send it to the environmental hazards of the sub- person prior to or at the time of ship- stance as specified in subpart E of this ment. part.

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(iii) The measures employees can (i) Skin irritation. take to protect themselves and the en- (ii) Respiratory complications. vironment from the substance, includ- (iii) Central nervous system effects. ing specific procedures the employer (iv) Internal organ effects. has implemented to protect employees (v) Birth defects. and the environment from exposure to (vi) Reproductive effects. the substance, including appropriate (vii) Cancer. work practices, emergency procedures, (viii) Immune system effects. personal protective equipment, engi- (ix) Developmental effects. neering controls, and other measures (2) Human health hazard pre- to control worker exposure and/or envi- cautionary statements: When using ronmental release required under sub- this substance: part E of the part, or alternative con- (i) Avoid skin contact. trol measures which EPA has deter- (ii) Avoid breathing substance. mined under § 721.30 provide substan- (iii) Avoid ingestion. tially the same degree of protection as (iv) Use respiratory protection. the specified control measures. (v) Use skin protection. (iv) The requirements of the hazard (3) Environmental hazard state- communication program developed by ments: This substance may be: the employer under this section, in- (i) Toxic to fish. cluding an explanation of the labeling (ii) Toxic to aquatic organisms. system and the MSDS required by this (4) Environmental hazard pre- section and guidance on obtaining and cautionary statements: Notice to using appropriate hazard information. users: (e) Low concentrations in mixtures. If a (i) Disposal restrictions apply. substance identified in subpart E of (ii) Spill clean-up restrictions apply. this part is present in the work area (iii) Do not release to water. only as a mixture, an employer is ex- (5) Each human health or environ- empt from the provisions of this sec- mental hazard precautionary state- tion if the concentration of the sub- ment identified in subpart E of this stance in the mixture does not exceed a part for the label on the substance con- concentration set in subpart E of this tainer must be followed by the state- part. The exemption does not apply if ment, ‘‘See MSDS for details.’’ the employer has reason to believe that (h) Human health, environmental haz- during intended use or processing in ard exposure and precautionary state- the work area, the substance in the ments. (1) Whenever referenced in sub- mixture may be concentrated above part E of this part for a substance, the the level set in subpart E of this part. following human health, environ- (f) Existing hazard communication pro- mental hazard, exposure, and pre- gram. The employer need not take addi- cautionary statements shall appear on tional actions if existing programs and each label as specified in paragraph (b) procedures satisfy the requirements of of this section. Additional statements this section. may be included as long as they are (g) Human health, environmental haz- true and do not alter the meaning of ard, exposure, and precautionary state- the required statements. ments. Whenever referenced in subpart (i) Precautionary statements. (A) The E of this part for a substance, the fol- health effects of this chemical sub- lowing human health and environ- stance have not been determined. mental hazard, exposure, and pre- (B) When using this substance, use cautionary statements shall appear on skin protection. each label as specified in paragraph (b) (C) Use respiratory protection when of this section and the MSDS as speci- there is a reasonable likelihood of ex- fied in paragraph (c) of this section. posure in the work area from dust, Additional statements may be included mist, or smoke from spray application. as long as they are true and do not (D) Chemicals similar in structure to alter the meaning of the required this substance have been found to statements. cause cancer in laboratory animals. (1) Human health hazard statements: (ii) Human health hazard statements. This substance may cause: This substance may cause:

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(A) Skin irritation (C) Central nervous system effects (B) Respiratory complications (D) Internal organ effects (C) Central nervous system effects (E) Birth defects (D) Internal organ effects (F) Reproductive effects (E) Birth defects (G) Cancer (F) Reproductive effects (H) Immune system effects (G) Cancer (I) Developmental effects (H) Immune system effects (iii) Human health hazard pre- (I) Developmental effects cautionary statements. When using this (iii) Human health hazard pre- substance: cautionary statements. When using this (A) Avoid skin contact substance: (B) Avoid breathing substance (A) Avoid skin contact (C) Avoid ingestion (B) Avoid breathing substance (D) Use respiratory protection (C) Avoid ingestion (E) Use skin protection (D) Use respiratory protection (iv) Environmental hazard statements. (E) Use skin protection This substance may be: (iv) Environmental hazard statements. (A) Toxic to fish This substance may be: (B) Toxic to aquatic organisms (A) Toxic to fish (v) Environmental hazard pre- (B) Toxic to aquatic organisms cautionary statements. Notice to Users: (v) Environmental hazard pre- (A) Disposal restrictions apply cautionary statements. Notice to Users: (B) Spill clean-up restrictions apply (A) Disposal restrictions apply (C) Do not release to water. (B) Spill clean-up restrictions apply (C) Do not release to water. [54 FR 31308, July 27, 1989, as amended at 55 (vi) Additional statements. Each FR 45996, Oct. 31, 1990; 58 FR 34204, June 23, human health or environmental pre- 1993] cautionary statement identified in subpart E of this part for the label on the § 721.80 Industrial, commercial, and consumer activities. substance container must be followed by the statement, ‘‘See MSDS for de- Whenever a substance is identified in tails.’’ subpart E of this part as being subject (2) Whenever referenced in subpart E to this section, a significant new use of of this part for a substance, the fol- the substance is: lowing human health, environmental (a) Use in non-enclosed processes. hazard, exposure, and precautionary (b) Any manner or method of manu- statements shall appear on each MSDS facture in non-enclosed processes asso- as specified in paragraph (c) of this sec- ciated with any use. tion. Additional statements may be in- (c) Any manner or method of proc- cluded as long as they are true and do essing in non-enclosed processes associ- not alter the meaning of the required ated with any use. statements. (d) Use beyond the site of manufac- (i) Precautionary statements. (A) The ture or import. health effects of this chemical sub- (e) Processing beyond the site of stance have not been determined. manufacture or import. (B) When using this substance, use (f) Any manner or method of manu- skin protection. facture (excluding import) of the sub- (C) Use respiratory protection when stance associated with any use. there is a reasonable likelihood of ex- (g) Use other than as an inter- posure in the work area from dust, mediate. mist, or smoke from spray application. (h) Use other than as a site-limited (D) Chemicals similar in structure to intermediate. this substance have been found to (i) Use as an intermediate where the cause cancer in laboratory animals. concentration of the intermediate sub- (ii) Human health hazard statements. stance in the product intended for dis- This substance may cause: tribution in commerce exceeds the con- (A) Skin irritation centration specified in subpart E of (B) Respiratory complications this part for the substance.

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(j) Use other than as described in the (w) Any manner or method of manu- premanufacture notice referenced in facture of the substance in the fol- subpart E of this part for the sub- lowing form associated with any use: stance. (1) A powder. (k) Use other than allowed by the (2) A solid. section 5(e) consent order referenced in (3) A liquid. subpart E of this part for the sub- (4) A gas. stance. (x) Any manner or method of proc- (l) Non-industrial use. essing of the substance in the following (m) Commercial use. form associated with any use: (n) Non-commercial use. (1) A powder. (o) Use in a consumer product. (2) A solid. (p) Aggregate manufacture and im- (3) A liquid. portation volume for any use greater (4) A gas. than that specified in subpart E of this (y) Use involving an application part for the substance. method that generates: (q) Aggregate manufacture and im- (1) A vapor, mist, or aerosol. portation volume for any use greater (2) A dust. than that allowed by the section 5(e) consent order referenced in subpart E § 721.85 Disposal. of this part for the substance. (r) Aggregate manufacture and im- Whenever a substance is identified in portation volume for any use greater subpart E of this part as being subject than that specified in subpart E of this to this section, a significant new use of part for the substance unless the man- the substance is any method of: ufacturer or importer has submitted (a) Disposal of the process stream as- the results of the health or environ- sociated with any use of the substance mental effects studies identified in sub- or with any manner or method of man- part E of this part for the substance ufacturing associated with any use of and those studies comply with the pro- the substance other than by the fol- cedures and criteria for developing and lowing. This provision does not evaluating data identified in subpart E supercede any applicable Federal, of this part for the substance. State, or local laws and regulations. (s) Annual manufacture and importa- (1) Incineration. tion volume for any use greater than (2) Landfill. that specified in subpart E of this part (3) Deep well injection. for the substance. (b) Disposal of the process stream as- (t) Annual manufacture and importa- sociated with any use or with any man- tion volume for any use greater than ner or method of processing associated that allowed by the section 5(e) con- with any use other than by the fol- sent order referenced in subpart E of lowing. This provision does not this part for the substance. supercede any applicable Federal, (u) Annual manufacture and importa- State, or local laws and regulations. tion volume for any use greater than (1) Incineration. that specified in subpart E of this part (2) Landfill. for the substance unless the manufac- (3) Deep well injection. turer or importer has submitted the re- (c) Disposal of the use stream associ- sults of the health or environmental ef- ated with any use, other than by the fects studies identified in subpart E of following. This provision does not this part for the substance and those supercede any applicable Federal, studies comply with the procedures and State, or local laws and regulations. criteria for developing and evaluating (1) Incineration. data identified in subpart E of this part (2) Landfill. for the substance. (3) Deep well injection. (v) Use in the form of: (d) Disposal of the substance associ- (1) A powder. ated with any use of the substance, or (2) A solid. with any manner or method of manu- (3) A liquid. facture or processing in association (4) A gas. with any use. This provision does not

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supercede any applicable Federal, tion of treatment by the discharger State, or local laws and regulations. and the publicly-owned treatment works: § 721.90 Release to water. (i) Chemical precipitation and set- Whenever a substance is identified in tling. subpart E of this part as being subject (ii) Biological treatment (activated to this section, a significant new use of sludge or equivalent) plus clarification. the substance is: (iii) Steam stripping. (a) Any predictable or purposeful re- (iv) Resin or activated carbon adsorp- lease of a manufacturing stream asso- tion. ciated with any use of the substance, (v) Chemical destruction or conver- from any site: sion. (1) Into the waters of the United (vi) Primary wastewater treatment. States. (3) Into the waters of the United (2) Into the waters of the United States without primary wastewater States without application of one or treatment, and secondary wastewater more of the following treatment tech- treatment as defined in 40 CFR part nologies as specified in subpart E of 133. this part either by the discharger or, in (4) Into the waters of the United the case of a release through publicly- States if the quotient from the fol- owned treatment works, by a combina- lowing formula:

exceeds the level specified in subpart E more of the following treatment tech- of this part when calculated using the nologies as specified in subpart E of methods described in § 721.91. In lieu of this part either by the discharger or, in calculating the above quotient, moni- the case of a release through publicly- toring or alternative calculations may owned treatment works, by a combina- be used to predict the surface water tion of treatment by the discharger concentration which will result from and the publicly-owned treatment the intended release of the substance, works: if the monitoring procedures or cal- (i) Chemical precipitation and set- culations have been approved for such tling. purpose by EPA. EPA will review and (ii) Biological treatment (activated act on written requests to approve sludge or equivalent) plus clarification. monitoring procedures or alternative (iii) Steam stripping. calculations within 90 days after such (iv) Resin or activated carbon adsorp- requests are received. EPA will inform tion. submitters of the disposition of such requests in writing, and will explain (v) Chemical destruction or conver- the reasons therefor when they are de- sion. nied. (vi) Primary wastewater treatment. (b) Any predictable or purposeful re- (3) Into the waters of the United lease of a process stream containing States without primary wastewater the substance associated with any use treatment, and secondary wastewater of the substance from any site: treatment as defined in 40 CFR part (1) Into the waters of the United 133. States. (4) Into the waters of the United (2) Into the waters of the United States if the quotient from the fol- States without application of one or lowing formula:

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exceeds the level specified in subpart E more of the following treatment tech- of this part when calculated using the nologies as specified in subpart E of methods described in § 721.91. In lieu of this part either by the discharger or, in calculating the above quotient, moni- the case of a release through publicly- toring or alternative calculations may owned treatment works, by a combina- be used to predict the surface water tion of treatment by the discharger concentration which will result from and the publicly-owned treatment the intended release of the substance, works: if the monitoring procedures or cal- (i) Chemical precipitation and set- culations have been approved for such tling. purpose by EPA. EPA will review and act on written requests to approve (ii) Biological treatment (activated monitoring procedures or alternative sludge or equivalent) plus clarification. calculations within 90 days after such (iii) Steam stripping. requests are received. EPA will inform (iv) Resin or activated carbon adsorp- submitters of the disposition of such tion. requests in writing, and will explain (v) Chemical destruction or conver- the reasons therefor when they are de- sion. nied. (vi) Primary wastewater treatment. (c) Any predictable or purposeful re- (3) Into the waters of the United lease of a use stream containing the States without primary wastewater substance associated with any use of treatment, and secondary wastewater the substance from any site: treatment as defined in 40 CFR part (1) Into the waters of the United 133. States. (2) Into the waters of the United (4) Into the waters of the United States without application of one or States if the quotient from:

exceeds the level specified in subpart E § 721.91 Computation of estimated sur- of this part, when calculated using the face water concentrations: Instruc- methods described in § 721.91. In lieu of tions. calculating the above quotient, how- These instructions describe the use of ever, monitoring or alternative cal- the equation specified in § 721.90(a)(4) culations may be used to predict the and (b)(4) to compute estimated surface surface water concentration expected water concentrations which will result to result from intended release of the from release of a substance identified substance, if the monitoring proce- in subpart E of this part. The equation dures or calculations have been ap- shall be computed for each site using proved for such purpose by EPA. EPA the stream flow rate appropriate for will review and act on written requests the site according to paragraph (b) of to approve monitoring procedures or this section, and the highest number of alternative calculations within 90 days kilograms calculated to be released for after such requests are received. EPA that site on a given day according to will inform submitters of the disposi- paragraph (a) of this section. Two vari- tion of such requests in writing, and ables shall be considered in computing will explain the reasons therefor when the equation, the number of kilograms they are denied. released, and receiving stream flow.

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(a) Number of kilograms released. (1) To where the waste stream results from calculate the number of kilograms of separation of organic/water phases or substance to be released from manufac- filtration of the substance from an turing, processing, or use operations, aqueous stream to be discharged. as specified in the numerator of the (iii) Measurements of flow rates of equation, develop a process description the process/use stream and known con- diagram which describes each manufac- centrations of the substance in the turing, processing, or use operation in- stream. volving the substance. The process de- (5) After releases of a substance to scription must include the major unit water are estimated for each operation operation steps and chemical conver- on a site, total the releases of the sub- sions. A unit operation is a functional stance to water from all operations at step in a manufacturing, processing, or that site. The value (number of kilo- use operation where substances under- grams) specified in the numerator of go chemical changes and/or changes in the equation should reflect total kilo- location, temperature, pressure, phys- grams of substance released to water ical state, or similar characteristics. per day from all operations at a single Include steps in which the substance is site. formulated into mixtures, suspensions, (6) Use the highest expected daily re- solutions, etc. lease of the substance for each site. (2) Indicate on each diagram the (b) Receiving stream flow. (1) The re- entry point of all feedstocks (e.g., ceiving stream flow shall be expressed reactants, solvents, and catalysts) used in the operation. Identify each feed- in million liters per day (MLD). The stock and specify its approximate flow rate data to be used must be for weight regardless of whether the proc- the point of release on the water body ess is continuous or batch. that first receives release of the sub- (3) Identify all release points from stance whether by direct discharge which the substance or wastes con- from a site, or by indirect discharge taining the substance will be released through a Publicly-Owned Treatment into air, land, or water. Indicate these Works (POTW) for each site. The flow release points on the diagram. Do not rate reported shall be the lowest 7-day include accidental releases or fugitive average stream flow with a recurrence emissions. interval of 10 years (7-Q-10). If the 7-Q- (4) For releases identified in the dia- 10 flow rate is not available for the ac- gram that are destined for water, esti- tual point of release, the stream flow mate the amount of substance that will rate should be used from the U.S. Geo- be released before the substance enters logical Survey (USGS) gauging station control technology. The kilograms of that is nearest the point of release that substance released may be estimated is expected to have a flow rate less based on: than or equal to the receiving stream (i) The mass balance of the operation, flow at the point of release. i.e., totaling inputs and outputs, in- (2) Receiving stream flow data may cluding wastes for each part of the be available from the National Pollut- process such that outputs equal inputs. ant Discharge Elimination System The amount released to water may be (NPDES) permit for the site or the the difference between the amount of POTW releasing the substance to sur- the substance in the starting material face water, from the NPDES permit- (or formed in a reaction) minus the writing authority for the site or the amount of waste material removed POTW, or from USGS publications, from each part of the process and not such as the water-data report series. released to water and the amount of (3) If receiving stream flow data are the substance in the final product. not available for a stream, either the (ii) Physical properties such as water value of 10 MLD or the daily flow of solubility where a known volume of wastewater from the site or the POTW water being discharged is assumed to releasing the substance must be used contain the substance at concentra- as an assumed minimum stream flow. tions equal to its solubility in water. Similarly, if stream flow data are not This approach is particularly useful available because the location of the

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point of release of the substance to sur- sons outside the site of manufacture, face water is a lake, estuary, bay, or importation, or processing to whom ocean, then the flow rate to be used the manufacturer, importer, or proc- must be the daily flow of wastewater essor directly sells or transfers the sub- from the site or the POTW releasing stance, the date of each sale or trans- the substance to surface water. Waste- fer, and the quantity of the substance water flow data may be available from sold or transferred on such date. the NPDES permit or NPDES author- (d) Records documenting establish- ity for the site or the POTW releasing ment and implementation of a program the substance to water. for the use of any applicable personal protective equipment required under Subpart C—Recordkeeping § 721.63. Requirements (e) Records documenting the determinations required by § 721.63(a)(3) that § 721.100 Applicability. chemical protective clothing is impervious to the substance. This subpart C identifies certain ad- (f) Records documenting establish- ditional recordkeeping requirements ment and implementation of the haz- applicable to manufacturers, import- ard communication program required ers, and processors of substances iden- under § 721.72. tified in subpart E of this part for each (g) Copies of labels required under specific substance. The provisions of § 721.72(b). this subpart C apply only when ref- (h) Copies of material safety data erenced in subpart E of this part for a sheets required under § 721.72(c). substance and significant new use iden- (i) Records documenting compliance tified in that subpart E. If the provi- with any applicable industrial, com- sions in this subpart C conflict with mercial, and consumer use limitations general provisions of subpart A of this under § 721.80. part, the provisions of this subpart C (j) Records documenting compliance shall apply. with any applicable disposal require- [54 FR 31313, July 27, 1989] ments under § 721.85, including the method of disposal, location of disposal § 721.125 Recordkeeping requirements. sites, dates of disposal, and volume of At the time EPA adds a substance to the substance disposed. Where the esti- subpart E of this part, EPA will specify mated disposal volume is not known to appropriate recordkeeping require- or reasonably ascertainable by the ments which correspond to the signifi- manufacturer, importer, or processor, cant new use designations for the sub- that person must maintain other stance selected from subpart B of this records which demonstrate establish- part. Each manufacturer, importer, ment and implementation of a program and processor of the substance shall that ensures compliance with any ap- maintain the records for 5 years from plicable disposal requirements. the date of their creation. In addition (k) Records documenting establish- to the records specified in § 721.40, the ment and implementation of proce- records whose maintenance this sec- dures that ensure compliance with any tion requires may include the fol- applicable water discharge limitations lowing: under § 721.90. (a) Records documenting the manu- [54 FR 31313, July 27, 1989] facture and importation volume of the substance and the corresponding dates Subpart D—Expedited Process for of manufacture and import. Issuing Significant New Use (b) Records documenting volumes of the substance purchased in the United Rules for Selected Chemical States by processors of the substance, Substances and Limitation or names and addresses of suppliers, and Revocation of Selected Sig- corresponding dates of purchase. nificant New Use Rules (c) Records documenting the names and addresses (including shipment des- SOURCE: 54 FR 31314, July 27, 1989, unless tination address, if different) of all per- otherwise noted.

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§ 721.160 Notification requirements for rulemaking, or notice and comment new chemical substances subject to rulemaking. EPA will use the direct section 5(e) orders. final rulemaking process to issue sig- (a) Selection of substances. (1) In ac- nificant new use rules unless it deter- cordance with the expedited process mines that, in a particular case, one of specified in this section, EPA will issue the other processes is more appro- significant new use notification re- priate. quirements and other specific require- (2) FEDERAL REGISTER documents ments for each new chemical substance issued to propose or establish signifi- that is the subject of a final order cant new uses under this section will issued under section 5(e) of the Act, ex- contain the following: cept for an order that prohibits manu- (i) The chemical identity of the sub- facture and import of the substance, stance or, if its specific identity is unless EPA determines that significant claimed confidential, an appropriate new use notification requirements are generic chemical name and an acces- not needed for the substance. sion number assigned by EPA. (2) If EPA determines that signifi- (ii) The premanufacture notice num- cant new use notification requirements ber. are not needed for a substance that is (iii) The CAS number, where avail- subject to a final order issued under able and not claimed confidential. section 5(e) of the Act, except for an (iv) A summary of EPA’s findings order that prohibits manufacture or under section 5(e)(1)(A) of the Act for import of the substance, EPA will issue the final order issued under section a notice in the FEDERAL REGISTER ex- 5(e). plaining why the significant new use (v) Designation of the significant new requirements are not needed. uses subject to, or proposed to be sub- (b) Designation of requirements. (1) The ject to, notification and any other ap- significant new use notification and plicable requirements. other specific requirements will be (vi) Any modifications of subpart A based on and be consistent with the of this part applicable to the specific provisions included in the final order substance and significant new uses. issued for the substance under section (vii) If the FEDERAL REGISTER docu- 5(e) of the Act. EPA may also designate ment establishes a final rule, or noti- additional activities as significant new fies the public that a final rule will not uses which will be subject to notifica- be issued after public comment has tion. Designation of additional activi- been received, the document will de- ties as significant new uses will be scribe comments received and EPA’s done in accordance with the criteria response. and procedures under § 721.170, or (3) Direct final rulemaking. (i) When through a separate rulemaking pro- EPA uses the direct final rulemaking ceeding. procedure to issue a significant new (2) Significant new use requirements use rule, it will issue a final rule in the and other specific requirements des- FEDERAL REGISTER following its deci- ignated under this section will be listed sion to develop a significant new use in subpart E of this part. For each sub- rule under this section for a specific stance, subpart E will identify: new chemical substance. (i) The chemical name. (ii) The FEDERAL REGISTER document (ii) The activities designated as sig- will state that, unless written notice is nificant new uses. received by EPA within 30 days of pub- (iii) Other specific requirements ap- lication that someone wishes to submit plicable to the substance, including adverse or critical comments, the rule recordkeeping requirements or any will be effective 60 days from the date other requirements included in the of publication. The written notice of final section 5(e) order. intent to submit adverse or critical (c) Procedures for issuing significant comments should state which SNUR(s) new use rules. (1) EPA will issue signifi- will be the subject of the adverse or cant new use rules under this section critical comments, if several SNURs by one of the following three processes: are established through the direct final direct final rulemaking, interim final rule. If notice is received within 30

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days that someone wishes to submit in the 180-day period, EPA issues a adverse or critical comments, the sec- final rule in the FEDERAL REGISTER re- tion(s) of the direct final rule con- sponding to any written comments retaining the SNUR(s) for which a notice ceived during the 30-day comment pe- of intent to comment was received will riod specified in paragraph (c)(5)(i)(B) be withdrawn by EPA issuing a docu- of this section and promulgating final ment in the final rule section of the significant new use notification re- FEDERAL REGISTER, and a proposal will quirements and other requirements for be published in the proposed rule sec- the substance. tion of the FEDERAL REGISTER. The pro- (d) Schedule for issuing significant new posal will establish a 30-day comment use rules. (1) Unless EPA determines period. that a significant new use rule should (iii) If EPA, having considered any timely comments submitted in re- not be issued under this section, EPA sponse to the proposal, decides to es- will issue a proposed rule, a direct final tablish notification requirements rule, or an interim final rule within 180 under this section, EPA will issue a days of receipt of a valid notice of com- final rule adding the substance to sub- mencement under § 720.102 of this chap- part E of this part and designating the ter for any substance for which the no- significant new uses subject to notifi- tice of commencement was received on cation. or after October 10, 1989. (4) Notice and comment rulemaking. (i) (2) Unless EPA determines that a sig- When EPA uses a notice and comment nificant new use rule should not be procedure to issue a significant new issued under this section, EPA will use rule, EPA will issue a proposal in issue a proposed rule, a direct final the FEDERAL REGISTER following its de- rule, or an interim final rule within 1 cision to develop a significant new use year of October 10, 1989, for any sub- rule under this section for a specific stance for which the valid notice of new chemical substance. Persons will commencement under § 720.102 of this be given 30 days to comment on wheth- chapter was received before October 10, er EPA should establish notification 1989. requirements for the substance under (3) If EPA receives adverse or critical this part. significant comments following publi- (ii) If EPA, having considered any cation of a proposed or interim final timely comments, decides to establish rule, EPA will either withdraw the rule notification requirements under this or issue a final rule addressing the section, EPA will issue a final rule add- comments received. ing the substance to subpart E of this part and designating the significant § 721.170 Notification requirements for new uses subject to notification. selected new chemical substances (5) Interim final rulemaking. (i) When that have completed premanu- EPA uses the interim final rulemaking facture review. procedure to issue a significant new (a) Selection of substances. In accord- use rule, EPA will issue an interim ance with the expedited process speci- final rule in the final rule section of fied in this section, EPA may issue sig- the FEDERAL REGISTER following its decision to develop a significant new use nificant new use notification and rec- rule for a specific new chemical sub- ordkeeping requirements for any new stance. The document will state EPA’s chemical substance for which a reasons for using the interim final premanufacture notice has been sub- rulemaking procedure. mitted under part 720 of this chapter if (A) The significant new use rule will EPA determines that activities other take effect on the date of publication. than those described in the (B) Persons will be given 30 days from premanufacture notice may result in the date of publication to submit com- significant changes in human exposure ments. or environmental release levels and/or (ii) Interim final rules issued under that concern exists about the sub- this section shall cease to be in effect stance’s health or environmental ef- 180 days after publication unless, with- fects.

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(b) Concern criteria. EPA may deter- or developmentally toxic effects under mine that concern exists about a sub- reasonably anticipated conditions of stance’s health or environmental ef- exposure because the substance: fects if EPA makes any one of the fol- (i) Has been shown by valid test data lowing findings: to cause serious chronic effects, serious (1)(i) The substance may cause car- acute effects, or developmentally toxic cinogenic effects because the sub- effects in humans or in at least one stance: species of laboratory animal at dose (A) Has been shown by valid test data levels that could be of concern under to cause carcinogenic effects in hu- reasonably anticipated conditions of mans or in at least one species of lab- exposure. oratory animal. (ii) Is closely analogous, based on (B) Has been shown to be a possible toxicologically relevant similarities in carcinogen based on the weight of the molecular structure and physical prop- evidence in short-term tests indicative erties, to another chemical substance of the potential to cause carcinogenic that has been shown by valid test data effects. to cause serious chronic effects, serious (C) Is closely analogous, based on acute effects, or developmentally toxic toxicologically relevant similarities in effects in humans or in at least one molecular structure and physical prop- species of laboratory animal at dose erties, to another substance that has levels that could be of concern under been shown by test data to cause car- reasonably anticipated conditions of cinogenic effects in humans or in at exposure, provided that if there is more least one species of laboratory animal, than one such analogue, the greatest provided that if there is more than one weight will be given to the relevant such analogue, the greatest weight will data for the most appropriate ana- be given to the relevant data for the logues. most appropriate analogues. (iii) Is known or can reasonably be (D) Is known or can reasonably be an- anticipated, based on valid scientific ticipated, based on valid scientific data data or established scientific prin- or established scientific principles, to ciples, to be metabolized in humans or be metabolized in humans or trans- transformed in the environment to a formed in the environment to a sub- substance which may have the poten- stance which may have the potential to tial to cause serious chronic effects, se- cause carcinogenic effects under the rious acute effects, or developmentally criteria in paragraphs (b)(1)(i) (A), (B), toxic effects under the criteria in para- or (C) of this section. graph (b)(3) (i) and (ii) of this section. (ii) No substance may be regulated (iv) Has been shown to potentially based on a finding under paragraph cause developmentally toxic effects (b)(1) of this section unless EPA has based on the weight of the evidence in also made the finding under short-term tests indicative of the po- § 721.170(c)(2)(ii). tential to cause developmentally toxic (2) The substance has been shown by effects. valid test data to cause acutely toxic (4) The substance may cause signifi- effects in at least one species of labora- cant adverse environmental effects tory animal or is closely analogous, under reasonably anticipated condi- based on toxicologically relevant simi- tions of release because the substance: larities in molecular structure and (i) Has been shown by valid test data physical properties, to another sub- to cause significant adverse environ- stance that has been shown by valid mental effects at dose levels that could test data to cause acutely toxic effects be of concern under reasonably antici- in at least one species of laboratory pated conditions of release. animal, provided that if there is more (ii) Is closely analogous, based on than one such analogue, the greatest toxicologically relevant similarities in weight will be given to the relevant molecular structure and physical prop- data for the most appropriate ana- erties, to another substance that has logues. been shown by valid test data to cause (3) The substance may cause serious significant adverse environmental ef- chronic effects, serious acute effects, fects at dose levels that could be of

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concern under reasonably anticipated (2) EPA may designate as a signifi- conditions of release, provided that if cant new use only those activities that there is more than one such analogue, (i) are different from those described in the greatest weight will be given to the the premanufacture notice for the sub- relevant data for the most appropriate stance, including any amendments, de- analogues. letions, and additions of activities to (iii) Has been determined, based on the premanufacture notice, and (ii) calculations using the substance’s may be accompanied by changes in ex- physical and chemical properties, to be posure or release levels that are sig- potentially able to cause significant nificant in relation to the health or en- adverse environmental effects at dose vironmental concerns identified under levels that could be of concern under paragraph (b) of this section. reasonably anticipated conditions of (d) Procedures for issuing significant release. new use rules. (1) Significant new use (iv) Is known or can reasonably be requirements designated under this anticipated, based on valid scientific section will be listed in subpart E of data or established scientific prin- this part. For each substance, subpart ciples, to be environmentally trans- E of this part will identify: formed to a substance which may have (i) The chemical name. the potential to cause significant ad- (ii) The activities designated as sig- verse environmental effects under the nificant new uses, which may include criteria in paragraph (b)(4) (i), (ii), and one or more of the activities described (iii) of this section. in paragraph (c) of this section. (5) Concern exists about the health or (iii) Other specific requirements ap- environmental effects of one or more plicable to the substance. impurities or byproducts of the sub- (2) When EPA determines that a substance because the impurity or byprod- stance is a candidate for a significant uct meets one or more of the criteria in new use rule under this section, it will paragraph (b) (1) through (4) of this sec- notify the person that submitted the tion and either: premanufacture notice for the sub- (i) The impurity or byproduct is a stance no later than 7 calendar days new chemical substance and may be before the expiration of the notice represent in concentrations that could view period under § 720.75 of this chap- cause adverse health or environmental ter. In providing this notice, EPA will effects under reasonably anticipated describe the health or environmental conditions of exposure or release. concerns identified under paragraph (b) (ii) Reasonably anticipated manufac- of this section and the activities under ture, processing, or use activities in- consideration for designation as sig- volving the substance for which a nificant new uses. Such notice may be premanufacture notice has been sub- by telephone, but in this event will be mitted may result in significantly in- confirmed in writing no later than 30 creased human exposure to or environ- days after completion of the notice re- mental release of the impurity or by- view period. product compared to exposure or re- (3) FEDERAL REGISTER documents lease levels resulting from existing ac- issued to propose or establish signifi- tivities involving the impurity or by- cant new uses under this section will product. contain the following: (c) Designation of requirements. (1) (i) The chemical identity of the sub- When EPA decides to establish signifi- stance or, if its specific identity is cant new use reporting requirements claimed confidential, an appropriate under this section, EPA may designate generic chemical name and an acces- as a significant new use any one or sion number assigned by EPA. more of the activities set forth in sub- (ii) The premanufacture notice num- part B of this part. In addition, EPA ber. may designate specific recordkeeping (iii) The CAS number, where avail- requirements described under subpart able and not claimed confidential. C of this part that are applicable to the (iv) A summary of the basis for ac- substance. tion under this section.

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(v) Designation of the significant new (C) If EPA, having considered any uses subject to, or proposed to be sub- timely comments submitted in reject to, notification and any other ap- sponse to the proposal, decides to es- plicable requirements. tablish notification requirements (vi) Any modifications of subpart A under this section, EPA will issue a of this part applicable to the specific final rule adding the substance to sub- substance and significant new uses. part E of this part and designating the (vii) If the FEDERAL REGISTER docu- significant new uses subject to notifi- ment establishes a final rule, or noti- cation. fies the public that a final rule will not (ii)(A) When EPA uses a notice and be issued after public comment has comment procedure to issue a signifi- been received, the document will de- cant new use rule, EPA will issue a scribe comments received and EPA’s proposed rule in the FEDERAL REGISTER response. following its decision to develop a sig- (4) EPA will issue significant new use nificant new use rule under this section rules under this section by one of the for a specific new chemical substance. following three processes: direct final Persons will be given 30 days to com- rulemaking, interim final rulemaking, ment on whether EPA should establish or notice and comment rulemaking. notification requirements for the substance under this part. EPA will use the direct final rule- (B) If EPA, having considered any making process to issue significant timely comments, decides to establish new use rules unless it determines notification requirements under this that, in a particular case, one of the section, EPA will issue a final rule add- other processes is more appropriate. ing the substance to subpart E of this (i)(A) When EPA uses the direct final part and designating the significant rulemaking procedure to issue a sig- new uses subject to notification. nificant new use rule it will issue a di- (iii)(A) When EPA uses the interim rect final rule in the final rule section final rulemaking procedure to issue a of the FEDERAL REGISTER following its significant new use rule, EPA will issue decision to develop a significant new an interim final rule in the final rule use rule under this section for a spe- section of the FEDERAL REGISTER fol- cific new chemical substance. lowing its decision to develop a signifi- (B) The FEDERAL REGISTER document cant new use rule for a specific new will state that, unless written notice is chemical substance. The document will received by EPA within 30 days after state EPA’s reasons for using the in- the date of publication that someone terim final rulemaking procedure. wishes to submit adverse or critical (1) The significant new use rule will comments, the SNUR will be effective take effect on the date of publication. 60 days from date of publication. The (2) Persons will be given 30 days from written notice of intent to submit ad- the date of publication to submit com- verse or critical comments should state ments. which SNUR(s) will be the subject of (B) An interim final rule issued under the adverse or critical comments, if this section shall cease to be in effect several SNURs are established through 180 days after publication unless, with- the direct final rule. If notice is rein the 180-day period, EPA issues a ceived within 30 days after the date of final rule in the FEDERAL REGISTER re- publication that someone wishes to sponding to any written comments resubmit adverse or critical comments, ceived during the 30-day comment pe- the section(s) of the direct final rule riod specified in paragraph containing the SNUR(s) for which a no- (d)(4)(iii)(A)(2) of this section and pro- tice of intent to comment was received mulgating final significant new use no- will be withdrawn by EPA issuing a tification requirements and other re- document in the final rule section of quirements for the substance. the FEDERAL REGISTER, and EPA will (e) Schedule for issuing significant new issue a proposed rule in the proposed use rules. (1) EPA will issue a proposed rule section of the FEDERAL REGISTER. rule, an interim final rule, or a direct The proposed rule will establish a 30- final rule within 270 days of receipt of day comment period. the notice of commencement under

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§ 720.102 of this chapter for any sub- examined new information, or has reex- stance for which the notice of com- amined the test data or other informa- mencement was received on or after tion or analysis supporting its finding October 10, 1989. under section 5(e)(1)(A)(ii)(I) of the (2) If EPA receives adverse or critical Act, and has concluded that a rational comments within the designated com- basis no longer exists for the findings ment period following publication of a that activities involving the substance proposed rule or an interim final rule, may present an unreasonable risk of EPA will either withdraw the rule or injury to human health or the environ- issue a final rule addressing the comment required under section 5(e)(1)(A) ments received. of the Act. [54 FR 31314, July 27, 1989, as amended at 60 (6) For a substance added to subpart FR 16316, Mar. 29, 1995] E of this part under § 721.160, certain activities involving the substance have § 721.185 Limitation or revocation of been designated as significant new uses certain notification requirements. pending the completion of testing, and (a) Criteria for modification or revoca- adequate test data developed in accord- tion. EPA may at any time modify or ance with applicable procedures and revoke significant new use notification criteria have been submitted to EPA. requirements for a chemical substance (b) Procedures for limitation or revoca- which has been added to subpart E of tion. Modification or revocation of sig- this part using the procedures under nificant new use notification require- § 721.160 or § 721.170. Such action may be ments for a substance that has been taken under this section if EPA makes added to subpart E of this part using one of the following determinations, the procedures described under § 721.160 unless other information shows that or § 721.170 may occur either at EPA’s the requirements should be retained: initiative or in response to a written (1) Test data or other information ob- request. tained by EPA provide a reasonable (1) Any affected person may request basis for concluding that activities des- modification or revocation of signifi- ignated as significant new uses of the cant new use notification requirements substance will not present an unrea- for a substance that has been added to sonable risk of injury to human health or the environment. subpart E of this part using the proce- (2) EPA has promulgated a rule under dures described in § 721.160 or § 721.170 section 4 or 6 of the Act, or EPA or an- by writing to the Director of the Office other agency has taken action under of Pollution Prevention and Toxics and another law for the substance that stating the basis for such request. All eliminates the need for significant new requests should be sent to the Docu- use notification under section 5(a)(2) of ment Control Office (DCO) (7407M), Of- the Act. fice of Pollution Prevention and Toxics (3) EPA has received significant new (OPPT), Environmental Protection use notices for some or all of the ac- Agency, 1200 Pennsylvania Ave., NW., tivities designated as significant new Washington, DC 20460–0001. ATTN: Re- uses of the substance and, after review- quest to amend significant new use ing such notices, concluded that there rule. The request must be accompanied is no need to require additional notice by information sufficient to support from persons who propose to engage in the request. identical or similar activities. (2) The Director of the Office of Pol- (4) EPA has examined new informa- lution Prevention and Toxics will con- tion, or has reexamined the test data sider the request, make a determina- or other information or analysis sup- tion whether to initiate rulemaking to porting its decision to add the sub- modify the requirements, and notify stance to subpart E of this part under the requester of that determination by § 721.170 and has concluded that the certified letter. If the request is denied, substance does not meet the criteria the letter will explain why EPA has under § 721.170(b). concluded that the significant new use (5) For a substance added to subpart notification requirements for that sub- E of this part under § 721.160, EPA has stance should remain in effect.

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(3) If EPA concludes that significant Subpart E—Significant New Uses new use notification requirements for a for Specific Chemical Substances substance should be limited or revoked, EPA will propose the changes in the § 721.225 2-Chloro-N-methyl-N-sub- FEDERAL REGISTER, briefly describe the stituted acetamide (generic name). grounds for the action, and provide interested parties an opportunity to com- (a) Chemical substance and significant ment. new uses subject to reporting. (1) The chemical substance 2-chloro-N-methyl- [54 FR 31314, July 27, 1989, as amended at 58 N-substituted acetamide (PMN P-84– FR 34204, June 23, 1993; 60 FR 34464, July 3, 393) is subject to reporting under this 1995; 71 FR 33641, June 12, 2006] section for the significant new uses de- EFFECTIVE DATE NOTE: At 76 FR 30836, May scribed in paragraph (a)(2) of this sec- 27, 2011, § 721.185 was amended by revising tion. paragraph (b)(1), effective July 26, 2011. For the convenience of the user, the revised text (2) The significant new uses are: is set forth as follows: (i) Protection in the workplace. Re- quirements as specified in § 721.63(a)(1), § 721.185 Limitation or revocation of certain notification requirements. (a)(3), (b) (concentration set at 1.0 percent), and (c). * * * * * (ii) Hazard communication program. Requirements as specified in § 721.72 (b) * * * (b)(2), (d), (e) (concentration set at 1.0 (1) Any affected person may request modi- percent), (f), (g)(1)(iv), (g)(2)(i), and fication or revocation of significant new use notification requirements for a substance (g)(2)(v). The provisions of § 721.72(d) re- that has been added to subpart E of this part quiring employees to be provided with using the procedures described in § 721.160 or information on the location and avail- § 721.170 by writing to the Director of the Of- ability of a written hazard communica- fice of Pollution Prevention and Toxics, and tion program and MSDSs do not apply stating the basis for such request. The request must be accompanied by the informa- when the written program and MSDSs tion sufficient to support the request. Per- are not required under § 721.72 (a) and sons submitting a request to EPA under this (c), respectively. The provision of part, unless allowed by 40 CFR 720.40(a)(2)(i), § 721.72(g) requiring placement of spe- (ii), or (iii), must submit the request to EPA cific information on an MSDS does not via EPA’s Central Data Exchange (CDX) apply when an MSDS is not required using EPA-provided e-PMN reporting software in the manner set forth in 40 CFR under § 721.72(c). 720.40(a)(2). See 40 CFR 720.40(a)(2)(iv) for in- (iii) Industrial, commercial, and con- formation on how to obtain the e-PMN soft- sumer activities. Requirements as speci- ware. Support documents related to these re- fied § 721.80(g). quests must also be submitted to EPA in the (b) Specific requirements. The provi- manner set forth in 40 CFR 720.40(a)(2)(i), (ii), or (iii). Paper requests must be submitted ei- sions of subpart A of this part apply to ther via U.S. mail to the Document Control this section except as modified by this Office (DCO) (7407M), Office of Pollution Pre- paragraph. vention and Toxics, Environmental Protec- (1) Recordkeeping. The recordkeeping tion Agency, 1200 Pennsylvania Ave., NW., requirements as specified in § 721.125 (a) Washington, DC 20460–0001; ATTN: Request through (g) and (i) are applicable to to Amend SNUR or submitted via courier to the Environmental Protection Agency, manufacturers, importers, and proc- OPPT Document Control Office (DCO), EPA essors of this substance. East Bldg., 1201 Constitution Ave., NW., Rm. (2) Limitations or revocation of certain 6428, Washington, DC 20004; ATTN: Request notification requirements. The provisions to Amend SNUR. Optical discs containing of § 721.185 apply to this significant new electronic requests must be submitted by courier to the Environmental Protection use rule. Agency, OPPT Document Control Office [55 FR 32412, Aug. 9, 1990, as amended at 57 (DCO), EPA East Bldg., 1201 Constitution FR 20424, May 13, 1992. Redesignated at 58 FR Ave., NW., Rm. 6428, Washington, DC 20004; 29946, May 24, 1993; 58 FR 34204, June 23, 1993] ATTN: Request to Amend SNUR.

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§ 721.267 N-[2-[(substituted essors of this substance: § 721.125 (a) dinitrophenyl)azo]diallylamino-4- through (e), and (i). substituted phenyl] acetamide (ge- (2) Limitations or revocation of certain neric name). notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The [56 FR 25988, June 5, 1991. Redesignated at 58 chemical substance identified generi- FR 29946, May 24, 1993, as amended at 58 FR cally as N-[2-[(substituted 34204, June 23, 1993] dinitrophenyl)azo]diallylamino-4-substituted phenyl] acetamide (PMN P-95– § 721.285 Acetamide, N-[4- 513) is subject to reporting under this (pentyloxy)phenyl]-, acetamide, N- section for the significant new uses de- [2-nitro-4-(pentyloxy)phenyl]-, and scribed in paragraph (a)(2) of this sec- acetamide, N-[2-amino-4- tion. (pentyloxy)phenyl]-. (2) The significant new uses are: (a) Chemical substances and significant (i) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substances identified as acet- fied in § 721.80(f). amide, N-[4-(pentyloxy)phenyl]- (PMN (ii) [Reserved] P-92–31), acetamide, N-[2-nitro-4- (b) Specific requirements. The provi- (pentyloxy)phenyl]- (PMN P-92–32), and sions of subpart A of this part apply to acetamide, N-[2-amino-4- this section except as modified by this (pentyloxy)phenyl]- (PMN P-92–33) are paragraph. subject to reporting under this section (1) Recordkeeping. Recordkeeping re- for the significant new uses described quirements as specified in § 721.125 (a), in paragraph (a)(2) of this section. (b), (c), and (i) are applicable to manu- (2) The significant new uses are: (i) facturers, importers, and processors of Industrial, commercial, and consumer ac- this substance. tivities. Requirements as specified in (2) Limitations or revocation of certain § 721.80(h). notification requirements. The provisions (ii) Release to water. Requirements as of § 721.185 apply to this section. specified in § 721.90 (a)(4), (b)(4), and [61 FR 63734, Dec. 2, 1996] (c)(4) (where N = 90 ppb for PMNs P-92– 31 and P-92–32, and N = 30 ppb for P-92– § 721.275 Halogenated-N-(2-propenyl)- 33). When calculating the surface water N-(substituted phenyl) acetamide. concentrations according to the in- (a) Chemical substances and significant structions in § 721.90(a)(4), the state- new uses subject to reporting. (1) The ment that the amount of the substance chemical substance identified generi- that will be released will be calculated cally as halogenated-N-(2-propenyl)-N- before the substance enters control (substituted phenyl) acetamide (P-83– technology does not apply. Instead, if 1085) is subject to reporting under this the waste stream containing the subsection for the significant new uses de- stance will be treated before release, scribed in paragraph (a)(2) of this sec- then the amount of the substance rea- tion. sonably likely to be removed from the (2) The significant new uses are: waste stream by such treatment may (i) Protection in the workplace. Re- be subtracted in calculating the num- quirements as specified in § 721.63 (a)(1) ber of kilograms released. No more and (a)(3). than 25 percent removal efficiency may (ii) Industrial, commercial, and con- be attributed to such treatment. sumer activities. Requirements as speci- (b) Specific requirements. The provi- fied in § 721.80(g). sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. The following rec- (i), and (k) are applicable to manufac- ordkeeping requirements are applicable turers, importers, and processors of to manufacturers, importers, and proc- this substance.

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(2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125(a), of § 721.185 apply to this section. (b), (c), (d), (e), and, (i) are applicable [58 FR 51702, Oct. 4, 1993] to manufacturers, importers, and processors of this chemical substance. § 721.303 Substituted acetate (generic). (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generi- [68 FR 70173, Dec. 17, 2003] cally as a substituted acetate (PMN P- 99–0365) is subject to reporting under § 721.305 Di-substituted acetophenone this section for the significant new use (generic). described in paragraph (a)(2) of this (a) Chemical substance and significant section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified generi- (i) Industrial, commercial, and con- cally as di-substituted acetophenone sumer activities. Requirements as speci- (PMN P-97–93) is subject to reporting fied in § 721.80(j). under this section for the significant (ii) [Reserved] (b) Specific requirements. The provi- new uses described in paragraph (a)(2) sions of subpart A of this part apply to of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Protection in the workplace. Re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.63 (a)(1), quirements as specified in § 721.125 (a), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (b) (b), (c), and (i) are applicable to manu- (concentration set at 1.0 percent), and facturers, importers, and processors of (c). this substance. (ii) Hazard communication program. (2) Limitations or revocation of certain Requirements as specified in § 721.72 (a), notification requirements. The provisions (b), (c), (d), (e) (concentration set at 1.0 of § 721.185 apply to this section. percent), (f), (g)(2)(i), (g)(2)(v). The fol- (3) Determining whether a specific use is lowing statement shall appear on each subject to this section. The provisions of label as specified in § 721.72(b) and the § 721.1725(b)(1) apply to this section. MSDS as specified in § 721.72(c): This [65 FR 81398, Dec. 26, 2000] substance is expected to be dermally absorbed and may cause effects to the § 721.304 Acetic acid, [(5-chloro-8-quin- liver, kidney, adrenal glands, and the olinyl)oxy-], 1-methyl hexyl ester. heart. (a) Chemical substance and significant (iii) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified as acetic fied in § 721.80(q). acid, [(5-chloro-8-quinolinyl)oxy-]-, 1- (b) Specific requirements. The provi- methylhexyl ester (PMN P-01–170; CAS sions of subpart A of this part apply to No. 99607–70–2) is subject to reporting this section except as modified by this under this section for the significant paragraph. new use described in paragraph (a)(1) of (1) Recordkeeping. Recordkeeping re- this section. quirements as specified in § 721.125 (a), (2) The significant new uses are: (b), (c), (d), (e), (f), (g), (h), and (i) are (i) Protection in the workplace. Re- applicable to manufacturers, import- quirements as specified in § 721.63(a)(1), ers, and processors of this substance. (a)(3), (a)(4), and (a)(5)(iv). (2) Limitations or revocation of certain (ii) Industrial, commercial, and con- notification requirements. The provisions sumer activities. Requirements as speci- of § 721.185 apply to this section. fied in § 721.80(f). (3) Determining whether a specific use is (b) The provi- Specific requirements. subject to this section. The provisions of sions of subpart A of this part apply to § 721.1725(b)(1) apply to this section. this section except as modified by this paragraph. [63 FR 44574, Aug. 20, 1998]

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§ 721.320 Acrylamide-substituted (i) Industrial, commercial, and con- epoxy. sumer activities. Requirements as speci- (a) Chemical substance and significant fied in § 721.80 (f), (v)(1), and (x)(1). new uses subject to reporting. (1) The (ii) [Reserved] chemical substance identified generi- (b) Specific requirements. The provi- cally as acrylamide-substituted epoxy sions of subpart A of this part apply to this section except as modified by this (PMN P-92–660) is subject to reporting paragraph. under this section for the significant (1) Recordkeeping. Recordkeeping renew uses described in paragraph (a)(2) quirements as specified in § 721.125 (a), of this section. (b), (c), and (i) are applicable to manu- (2) The significant new uses are: facturers, importers, and processors of (i) Protection in the workplace. Re- this substance. quirements as specified in § 721.63 (a)(1), (2) Limitations or revocation of certain (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(2)(iv), notification requirements. The provisions (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(ii), of § 721.185 apply to this section. (b) (concentration set at 0.1 percent), and (c). [68 FR 15079, Mar. 28, 2003] (ii) Hazard communication program. Requirements as specified in § 721.72 (a), § 721.323 Substituted acrylamide. (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (a) Chemical substance and significant (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), new uses subject to reporting. (1) The (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), chemical substance generically identi- (g)(3)(ii), (g)(4)(iii), and (g)(5). fied as substituted acrylamide (PMN P- (iii) Industrial, commercial, and con- 90–1687) is subject to reporting under sumer activities. Requirements as speci- this section for the significant new fied in § 721.80(q). uses described in paragraph (a)(2) of (iv) Release to water. Requirements as this section. specified in § 721.90 (a)(1), (b)(1), and (2) The significant new uses are: (i) (c)(1). Protection in the workplace. Require- (b) Specific requirements. The provi- ments as specified in § 721.63 (a)(1), sions of subpart A of this part apply to (a)(2)(iii), (a)(3), (a)(4), (a)(6)(ii), this section except as modified by this (a)(6)(v), (b) (concentration set at 0.1 paragraph. percent), and (c). Section 721.63 (1) Recordkeeping. Recordkeeping re- (a)(5)(i), (a)(5)(ii), and (a)(5)(iii) apply quirements as specified in § 721.125 (a) to manufacturing operations only; through (i) and (k) are applicable to § 721.63(a)(5)(ix), (a)(5)(x), and (a)(5)(xi) manufacturers, importers, and proc- apply to processing and use operations essors of this substance. only. (2) Limitations or revocation of certain (ii) Hazard communication program. notification requirements. The provisions Requirements as specified in § 721.72 (a), of § 721.185 apply to this section. (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(vi), (g)(1)(vii), (3) Determining whether a specific use is (g)(2)(ii) (g)(2)(iii), (g)(2)(iv), (g)(2)(v), subject to this section. The provisions of and (g)(5). The following additional § 721.1725(b)(1) apply to this section. statement shall appear on each label [58 FR 51681, Oct. 4, 1993] and MSDS as required by this paragraph: This substance may cause nerv- § 721.321 Substituted acrylamides and ous system effects. acrylic acid copolymer (generic). (iii) Industrial, commercial, and con- (a) Chemical substance and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80(q). chemical substance identified generi- (b) Specific requirements. The provi- cally as substituted acrylamides and sions of subpart A of this part apply to acrylic acid copolymer (PMN P-00–0490) this section. is subject to reporting under this sec- (1) Recordkeeping. Recordkeeping re- tion for the significant new use de- quirements as specified in § 721.125 (a) scribed in paragraph (a)(2) of this sec- through (i) are applicable to manufac- tion. turers, importers, and processors of (2) The significant new uses are: this substance.

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(2) Limitations or revocation of certain (ii) Hazard communication program. notification requirements. The provisions Requirements as specified in § 721.72 (a), of § 721.185 apply to this section. (b), (c), (d), (e) (concentration set at 1.0 (3) Determining whether a specific use is percent), (f), (g), (g)(1)(iv), (g)(2)(ii), subject to this section. The provisions of (g)(2)(iv), and (g)(5). The following § 721.1725(b)(1) apply to this section. statement shall appear on each label as [58 FR 51702, Oct. 4, 1993] specified in § 721.72(b) and the Material Safety Data Sheet (MSDS) as specified § 721.324 Alkoxylated acrylate polymer in § 721.72 (c): The substance may cause (generic). internal organ effects (kidney and (a) Chemical substance and significant blood). The requirements of this sec- new uses subject to reporting. (1) The tion do not apply when the PMN sub- chemical substance identified generi- stance is bound or embedded into a cally as alkoxylated acrylate polymer plastic, resin matrix, or pellet. (PMN P-98–807) is subject to reporting (iii) Industrial, commercial, and con- under this section for the significant sumer activities. Requirements as speci- new uses described in paragraph (a)(2) fied in § 721.80(q). of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified in § 721.90 (a)(1), (b)(1), and paragraph. (c)(1). (1) Recordkeeping. The following rec- (ii) [Reserved] ordkeeping requirements are applicable (b) Specific requirements. The provi- to manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance as specified in this section except as modified by this § 721.125 (a), (b), (c), (d), (f), (g), (h), and paragraph. (i). (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of (3) Determining whether a specific use is these substances. subject to this section. The provisions of (2) Limitations or revocation of certain § 721.1725(b)(1) apply to this section. notification requirements. The provisions of § 721.185 apply to this section. [65 FR 366, Jan. 5, 2000] [65 FR 366, Jan. 5, 2000] § 721.330 Aromatic acrylate (generic). § 721.329 Halogenated benzyl ester ac- (a) Chemical substance and significant rylate (generic). new uses subject to reporting. (1) The chemical substance identified generi- (a) Chemical substance and significant cally as an aromatic acrylate (PMN P- new uses subject to reporting. (1) The chemical substance identified generi- 01–420) is subject to reporting under cally as halogenated benzyl ester acry- this section for the significant new use late (PMN P-90–1527) is subject to re- described in paragraph (a)(2) of this porting under this section for the sig- section. nificant new uses described in para- (2) The significant new uses are: graph (a)(2) of this section. (i) Release to water. Requirements as (2) The significant new uses are: specified § 721.90(a)(1), (b)(1), and (c)(1). (i) Protection in the workplace. Re- (ii) [Reserved] quirements as specified in § 721.63 (a)(4), (b) Specific requirements. The provi- (a)(5)(i), (a)(5)(ii), (a)(5)(iv), (a)(5)(v), sions of subpart A of this part apply to (a)(6)(i), (b), and (c) (concentration set this section except as modified by this at 1.0 percent). The reporting require- paragraph. ment for § 721.63(a)(5)(i) applies only (1) Recordkeeping. Recordkeeping re- during manufacture. The reporting requirements as specified in § 721.125(a), quirement for § 721.63 (a)(5)(ii), (b), (c), and (k) are applicable to manu- (a)(5)(iv), and (a)(5)(v) applies only dur- facturers, importers, and processors of ing processing. this chemical substance.

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(2) Limitations or revocation of certain (b), (c), and (i) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this substance. [68 FR 70174, Dec. 17, 2003] (2) Limitations or revocation of certain notification requirements. The provisions § 721.333 Dimethyl alkylamine salt (ge- of § 721.185 apply to this section. neric). [61 FR 63734, Dec. 2, 1996] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.338 Salt of an acrylate copolymer chemical substances identified generi- (generic). cally as a Dimethyl alkylamine salt (a) Chemical substance and significant (PMNs P-99–0368 and P-99–0369) are sub- new uses subject to reporting. (1) The ject to reporting under this section for chemical substances identified generi- the significant new use described in cally as salt of an acrylate copolymer paragraph (a)(2) of this section. (PMNs P-00–0333 and P-00–0334) are sub- (2) The significant new uses are: ject to reporting under this section for (i) Industrial, commercial, and con- the significant new use described in sumer activities. Requirements as speci- paragraph (a)(2) of this section. fied in § 721.80(j). (2) The significant new uses are: (ii) [Reserved] (i) Industrial, commercial, and con- (b) Specific requirements. The provi- sumer activities. Requirements as speci- sions of subpart A of this part apply to fied in § 721.80 (v)(2), (w)(2), and (x)(2). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), and (i) are applicable to manu- paragraph. facturers, importers, and processors of (1) Recordkeeping. Recordkeeping re- this substance. quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), and (i) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this substance. (3) Determining whether a specific use is (2) Limitations or revocation of certain The provisions of subject to this section. notification requirements. The provisions § 721.1725(b)(1) apply to this section. of § 721.185 apply to this section. [65 FR 81398, Dec. 26, 2000] [68 FR 15079, Mar. 28, 2003] § 721.336 Perfluoroalkylethyl acrylate copolymer (generic name). § 721.405 Polyether acrylate. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified generically as a perfluoroalkylethyl acrylate cally as a polyether acrylate (PMN P- copolymer (PMN P-94–241) is subject to 95–666) is subject to reporting under reporting under this section for the sig- this section for the significant new nificant new uses described in para- uses described in paragraph (a)(2) of graph (a)(2) of this section. this section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial and consumer (i) Release to water. Requirements as activities. Requirements as specified in specified in § 721.90 (a)(1), (b)(1), and § 721.80(y)(1). (c)(1). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a),

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(b), (c), and (k) are applicable to manu- chemical substances identified generi- facturers, importers, and processors of cally as alkylphenylpolyetheralkanola- this substance. mines (PMNs P-97–880/881/882) are sub- (2) Limitations or revocation of certain ject to reporting under this section for notification requirements. The provisions the significant new uses described in of § 721.185 apply to this section. paragraph (a)(2) of this section. [63 FR 3419, Jan. 22, 1998] (2) The significant new uses are: (i) Release to water. Requirements as § 721.430 Oxo-substituted aminoal- specified in § 721.90 (a)(1), (b)(1), and kanoic acid derivative. (c)(1). (a) Chemical substance and significant (ii) [Reserved] new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substance identified generi- sions of subpart A of this part apply to cally as oxo-substituted amino alkan- this section except as modified by this oic acid derivative (PMN No. P-92–692) paragraph. is subject to reporting under this sec- (1) Recordkeeping. Recordkeeping re- tion for the significant new uses de- quirements as specified in § 721.125 (a), scribed in paragraph (a)(2) of this sec- (b), (c), and (k) are applicable to manu- tion. facturers, importers, and processors of (2) The significant new uses are: these substances. (i) Protection in the workplace. Re- (2) Limitations or revocation of certain quirements as specified in § 721.63 (a)(1), notification requirements. The provisions (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), of § 721.185 apply to this section. (a)(5)(iv), (a)(5)(v), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 percent), and [63 FR 44574, Aug. 20, 1998] (c). § 721.445 Substituted ethyl alkena- (ii) Hazard communication program. mide. Requirements as specified in § 721.72 (a) through (d), (e) (concentration set at (a) Chemical substance and significant 0.1 percent), (f), (g)(1)(iii), (g)(1)(iv), new uses subject to reporting. (1) The (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), chemical substance identified generi- (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), cally as a substituted ethyl alkenamide and (g)(5). (PMN No. P-86–1315) is subject to re- (iii) Release to water. Requirements as porting under this section for the sig- specified in § 721.90 (a)(1), (a)(2), and nificant new uses described in para- (a)(3). graph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 (a)(1), paragraph. (a)(3), (b) (concentration set at 0.1 per- (1) Recordkeeping. Recordkeeping recent), and (c). quirements as specified in § 721.125 (a) (ii) Hazard communication program. through (i) are applicable to manufac- Requirements as specified in § 721.72 (a), turers, importers, and processors of (b), (c), (d), (e) (concentration set at 0.1 this substance. percent), (f), (g)(1)(ii), (g)(1)(vii), (2) Limitations or revocation of certain (g)(2)(i), (g)(2)(iv), (g)(2)(v), and (g)(5). notification requirements. The provisions (iii) Industrial, commercial, and con- of § 721.185 apply to this significant new sumer activities. Use other than polym- use rule. erizing all residual materials from the (3) Determining whether a specific use is manufacture, processing, and equip- subject to this section. The provisions of ment rinsing of the PMN substance so § 721.1725(b)(1) apply to this section. that no monomers of the PMN sub- [58 FR 32236, June 8, 1993, as amended at 58 stance are released to the environment. FR 29946, May 24, 1993] (b) Specific requirements. The provisions of subpart A of this part apply to § 721.435 Alkylphenylpolyetheralkanol- this section except as modified by this amines (generic). paragraph. (a) Chemical substance and significant (1) Recordkeeping. Recordkeeping renew uses subject to reporting. (1) The quirements as specified in § 721.125 (a)

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through (i) are applicable to manufac- (1) Recordkeeping. Recordkeeping re- turers, importers, and processors of quirements as specified in § 721.125 (a), this substance. (b), (c), and (k) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this substance. of § 721.185 apply to this significant new (2) Limitations or revocation of certain use rule. notification requirements. The provisions of § 721.185 apply to this section. [58 FR 32236, June 8, 1993] [68 FR 15079, Mar. 28, 2003] § 721.450 Hydrofluorochloroalkene (generic). § 721.465 Alkoxylated alkylpolyol acrylates, adduct with alkylamine (a) Chemical substance and significant (generic). new uses subject to reporting. (1) The chemical substance identified generi- (a) Chemical substance and significant cally as a hydrofluorochloroalkene new uses subject to reporting. (1) The (PMN P-97–593) is subject to reporting chemical substances identified generi- under this section for the significant cally as alkoxylated alkylpolyol new uses described in paragraph (a)(2) acrylates, adduct with alkylamine of this section. (PMNs P-98–0082, P-98–0083, and P-98– (2) The significant new uses are: 0084 are subject to reporting under this (i) Industrial, commercial, and con- section for the significant new use described in paragraph (a)(2) of this sec- sumer activities. Requirements as speci- tion. fied in § 721.80(g). (2) The significant new uses are: (ii) [Reserved] (i) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(1), (b)(1), and sions of subpart A of this part apply to (c)(1). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. The recordkeeping sions of subpart A of this part apply to requirements specified in § 721.125 (a), this section except as modified by this (b), (c) and (i) are applicable to manu- paragraph. facturers, importers, and processors of (1) Recordkeeping. Recordkeeping re- this substance. quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), and (k) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this substance. [63 FR 44574, Aug. 20, 1998] (2) Limitations or revocation of certain notification requirements. The provisions § 721.463 Acrylate of polymer based on of § 721.185 apply to this section. isophorone diisocyanate (generic). [68 FR 15079, Mar. 28, 2003] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.480 Aminoester of chemical substance identified generi- polyalkenylated alkyldicarboxylic cally as acrylate of polymer based on acid (generic). isophorone diisocyanate (PMN P-00– (a) Chemical substance and significant 0626) is subject to reporting under this new uses subject to reporting. (1) The section for the significant new use de- chemical substance identified generi- scribed in paragraph (a)(2) of this sec- cally as Aminoester of polyalkenylated tion. alkyldicarboxylic acid (PMN P-99–0115) (2) The significant new uses are: is subject to reporting under this sec- (i) Release to water. Requirements as tion for the significant new uses de- specified in § 721.90 (a)(4), (b)(4), (c)(4) scribed in paragraph (a)(2) of this sec- (N=3 ppb). tion. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(1), (b)(1), and this section except as modified by this (c)(1). paragraph. (ii) [Reserved]

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(b) Specific requirements. The provi- (a)(5)(iii), (a)(6)(ii), (a)(6)(v), (b) (con- sions of subpart A of this part apply to centration set at 0.1 percent), and (c). this section except as modified by this (ii) Hazard communication program. paragraph. Requirements as specified in § 721.72 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), (d), (e) (concentration set at 0.1 quirements as specified in § 721.125 (a), percent), (f), (g)(1)(i), (g)(1)(iii), (b), (c), and (k) are applicable to manu- (g)(1)(iv), (g)(1)(v), (g)(1)(vi), (g)(1)(vii), facturers, importers, and processors of (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), this substance. (g)(2)(iv), (g)(2)(v), and (g)(5). (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this paragraph. [65 FR 81398, Dec. 26, 2000] (1) Recordkeeping requirements. The following recordkeeping requirements § 721.484 Fluorinated acrylic copoly- are applicable to manufacturers, im- mer (generic name). porters, and processors of this sub- (a) Chemical substance and significant stance, as specified in § 721.125 (a) new uses subject to reporting. (1) The through (h). chemical substance identified generi- (2) Limitations or revocation of certain cally as a fluorinated acrylic copoly- notification requirements. The provisions mer (PMN P-95–1208) is subject to re- of § 721.185 apply to this significant new porting under this section for the sig- use rule. nificant new uses described in paragraph (a)(2) of this section. [56 FR 15792, Apr. 17, 1991. Redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR (2) The significant new uses are: 34204, June 23, 1993] (i) Industrial, commercial, and consumer activities. Requirements as speci- § 721.520 Alanine, N-(2-carboxyethyl)- fied in § 721.80 (v)(1), (w)(1), (x)(1), and N-alkyl-, salt. (y)(1). (a) Chemical substance and significant (ii) [Reserved] new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substance identified generi- sions of subpart A of this part apply to cally as alanine, N-(2-carboxyethyl)-N- this section except as modified by this alkyl-, salt (P-89–336) is subject to re- paragraph. porting under this section for the sig- (1) Recordkeeping. Recordkeeping re- nificant new uses described in para- quirements as specified in § 721.125 (a), graph (a)(2) of this section. (b), (c), and (i) are applicable to manu- (2) The significant new uses are: facturers, importers, and processors of (i) Hazard communication program. Re- this substance. quirements as specified in § 721.72 (a), (2) Limitations or revocation of certain (b), (c), (d), (f), (g)(3)(ii), (g)(4)(i), and notification requirements. The provisions (g)(5). of § 721.185 apply to this section. (ii) Industrial, commercial, and consumer activities. Requirements as speci- [61 FR 63735, Dec. 2, 1996] fied in § 721.80(k) and (q). (iii) Release to water. Requirements as § 721.505 Halogenated acrylonitrile. specified in § 721.90 (a)(4), (b)(4), (c)(4) (a) Chemical substance and significant (where N = 100). The requirement of 40 new uses subject to reporting. (1) The CFR 721.91(a)(4) that the amount of the chemical substance identified generi- substance estimated to be released to cally as halogenated acrylonitrile, water is calculated before entering (PMN P-90–299) is subject to reporting control technology is not retained. In- under this section for the significant stead, if the waste stream containing new uses described in paragraph (a)(2) the PMN substance will be treated of this section. using biological treatment (activated (2) The significant new uses are: sludge or equivalent) plus clarification, (i) Protection in the workplace. Re- then the amount of PMN substance quirements as specified in § 721.63 (a)(1), reasonably likely to be removed from (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), the waste stream by such treatment

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may be subtracted in calculating the § 721.524 Alcohols, C6-12, ethoxylated, number of kilograms released. No more reaction product with maleic anhy- than 90 percent removal efficiency may dride. be attributed to such treatment. (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as alcohols, C6-12, ethoxylated, re- paragraph. action product with maleic anhydride (1) Recordkeeping requirements. The (PMN P-88–1108) is subject to reporting following recordkeeping requirements under this section for the significant are applicable to manufacturers, im- new uses described in paragraph (a)(2) porters, and processors of this sub- of this section. stance as specified in § 721.125 (a), (b), (2) The significant new uses are: (c), (f), (g), (h), (i), and (k). (i) Release to water. Requirements as (2) Limitations or revocation of certain specified in § 721.90 (a)(4), (b)(4), and notification requirements. The provisions (c)(4) (N = 300). of § 721.185 apply to this significant new (ii) [Reserved] use rule. (b) Specific requirements. The provi- (3) Determining whether a specific use is sions of subpart A of this part apply to subject to this section. The provisions of this section except as modified by this § 721.1725(b)(1) apply to this section. paragraph. [56 FR 15789, Apr. 17, 1991. Redesignated and (1) Recordkeeping. Recordkeeping re- amended at 58 FR 29946, May 24, 1993; 58 FR quirements as specified in § 721.125 (a), 34204, June 23, 1993] (b), (c), and (k) are applicable to manufacturers, importers, and processors of § 721.522 Oxirane, methyl-, polymer this substance. with oxirane, mono(3,5,5,- (2) Limitations or revocation of certain trimethylhexyl) ether. notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The chemical substance identified as [63 FR 3419, Jan. 22, 1998] oxirane, methyl-, polymer with § 721.525 1-propanol, 3-propoxy-. oxirane, mono(3,5,5,-trimethylhexyl) ether (PMN P-99–0669; CAS No. 204336– (a) Chemical substance and significant 40–3) is subject to reporting under this new uses subject to reporting. (1) The section for the significant new use de- chemical substance identified as 1-pro- scribed in paragraph (a)(2) of this sec- panol, 3-propoxy- (PMN P-00–0827; CAS No. 4161–22–2) is subject to reporting tion. (2) The significant new uses are: under this section for the significant (i) Industrial, commercial, and con- new use described in paragraph (a)(2) of this section. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80(j). (i) Protection in the workplace. Re- (ii) [Reserved] quirements as specified in § 721.63 (b) Specific requirements. The provi- (a)(2)(i) and (a)(3). sions of subpart A of this part apply to (ii) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80(o) and (j). (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), and (i) are applicable to manu- this section except as modified by this facturers, importers, and processors of paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), (d), and (i) are applicable to of § 721.185 apply to this section. manufacturers, importers, and proc- (3) Determining whether a specific use is essors of this substance. subject to this section. The provisions of (2) Limitations or revocation of certain § 721.1725(b)(1) apply to this section. notification requirements. The provisions [68 FR 15080, Mar. 28, 2003] of § 721.185 apply to this section.

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(3) Determining whether a specific use is (1) Recordkeeping. The following rec- subject to this section. The provisions of ordkeeping requirements are applicable § 721.1725(b)(1) apply to this section. to manufacturers, importers, and processors of this substance, as specified in [68 FR 15080, Mar. 28, 2003] § 721.125 (a) through (c), (e) through (f), § 721.530 Substituted aliphatic acid ha- (i) and (j). lide (generic name). (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this significant new chemical substance substituted ali- use rule. (3) phatic acid halide (PMN P-84–491) is Determining whether a specific use is The provisions of subject to reporting under this section subject to this section. § 721.1725(b)(1) apply to this section. for the significant new uses described in paragraph (a)(2) of this section. [55 FR 32412, Aug. 9, 1990. Redesignated and (2) The significant new uses are: amended at 58 FR 29946, May 24, 1993; 58 FR (i) Protection in the workplace. Re- 34204, June 23, 1993] quirements as specified in § 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i) through (a)(5)(iii), § 721.532 Substituted hydroxyalkane acetate (generic). (a)(6)(v), (a)(6)(vi), (b) (concentration set at 0.1 percent), and (c). (a) Chemical substance and significant (ii) Hazard communication program. new uses subject to reporting. (1) The Requirements as specified in § 721.72 chemical substance identified generi- (b)(2), (d), (e) (concentration set at 0.1 cally as substituted hydroxyalkane ac- percent), (f) and (g)(1)(vii), (g)(2)(i) etate (PMN P-00–0618) is subject to re- through (g)(2)(v), and (g)(4)(i). The pro- porting under this section for the sig- visions of § 721.72(d) requiring employ- nificant new use described in paragraph ees to be provided with information on (a)(2) of this section. the location and availability of a writ- (2) The significant new uses are: ten hazard communication program (i) Industrial, commercial, and con- and MSDSs do not apply when the sumer activities. Requirements as speci- written program and MSDS are not re- fied in § 721.80 (j). quired under § 721.72 (a) and (c), respec- (ii) [Reserved] tively. The provision of § 721.72(g) re- (b) Specific requirements. The provi- quiring placement of specific informa- sions of subpart A of this part apply to tion on an MSDS does not apply when this section except as modified by this an MSDS is not required under paragraph. § 721.72(c). (1) Recordkeeping. Recordkeeping re- (iii) Industrial, commercial, and con- quirements as specified in § 721.125 (a), sumer activities. Requirements as speci- (b), (c), and (i) are applicable to manu- fied in § 721.80(k). facturers, importers, and processors of (iv) Disposal. Requirements as speci- this substance. fied in § 721.85 (a)(1), (b)(1) and (c)(1). (In (2) Limitations or revocation of certain lieu of incineration, persons subject to notification requirements. The provisions this section may dispose of wastes con- of § 721.185 apply to this section. taining the substance by chemically (3) Determining whether a specific use is treating liquid wastes so that the first subject to this section. The provisions of hydrolysis product is less than 10 ppm § 721.1725(b)(1) apply to this section. prior to discharge or purifying the [68 FR 15080, Mar. 28, 2003] waste stream so that the first hydrolysis product is less than 10 ppm. Those § 721.533 Propane, 1,1,1,3,3- purified waste streams may be reused pentachloro-. or sold. All of the substance removed (a) Chemical substance and significant by these processes must be incinerated new uses subject to reporting. (1) The or treated and released as described in chemical substance identified as pro- this paragraph (a)(2)(iv).) pane, 1,1,1,3,3-pentachloro- (PMN P-99– (b) Specific requirements. The provi- 1327; CAS No. 23153–23–3) is subject to sions of subpart A of this part apply to reporting under this section for the sig- this section except as modified by this nificant new use described in paragraph paragraph. (a)(2) of this section.

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(2) The significant new uses are: stance has been incorporated into a (i) Industrial, commercial, and con- resin. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80(g). (i) Protection in the workplace. Re- (ii) [Reserved] quirements as specified in § 721.63 (a)(1), (b) Specific requirements. The provi- (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), (6)(i), sions of subpart A of this part apply to (b) (concentration set at 0.1 percent), this section except as modified by this and (c). As an alternative to the res- paragraph. piratory requirements in this section, (1) Recordkeeping. Recordkeeping re- manufacturers, importers, and proc- quirements as specified in § 721.125 (a), essors may use the New Chemical Ex- (b), (c), and (i) are applicable to manu- posure Limits provisions, including facturers, importers, and processors of sampling and analytical methods this substance. which have previously been approved (2) Limitations or revocation of certain by EPA for this substance, found in the notification requirements. The provisions 5(e) consent order for this substance. of § 721.185 apply to this section. As an alternative to the respiratory requirements in this section manufactur- [68 FR 15080, Mar. 28, 2003] ers, importers, and processors may use the New Chemical Exposure Limits § 721.535 Halogenated alkane (generic). provisions, including sampling and analytical methods which have pre- (a) Chemical substance and significant viously been approved by EPA for this new uses subject to reporting. (1) The substance, found in the 5(e) consent chemical substance identified generi- order for this substance. cally as halogenated alkane (PMN P- (ii) Hazard communication program. 01–433) is subject to reporting under Requirements as specified in § 721.72 (a), this section for the significant new use (b), (c), (d), (e) (concentration set at 0.1 described in paragraph (a)(2) of this percent), (g)(1)(vii), (g)(2)(iv), (g)(2)(v), section. (g)(3)(ii), (g)(4)(iii), and (g)(5). (2) The significant new uses are: (iii) Industrial, commercial, and con- (i) Industrial, commercial, and consumer activities. Requirements as speci- sumer activities. Requirements as specified in § 721.80(q). fied in § 721.80(g). (iv) [Reserved] (ii) [Reserved] (v) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(1), (b)(1), and sions of subpart A of this part apply to (c)(1). this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125(a), paragraph. (b), (c), and (i) are applicable to manu- (1) Recordkeeping. Recordkeeping re- facturers, importers, and processors of quirements as specified in § 721.125 (a) this chemical substance. through (i), and (k) are applicable to (2) Limitations or revocation of certain manufacturers, importers, and proc- notification requirements. The provisions essors of this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain [68 FR 70174, Dec. 17, 2003] notification requirements. The provisions of § 721.185 apply to this section. § 721.536 Halogenated phenyl alkane. (3) Determining whether a specific use is subject to this section. The provisions of (a) Chemical substance and significant § 721.1725(b)(1) apply to this section. new uses subject to reporting. (1) The chemical substance identified generi- [58 FR 51681, Oct. 4, 1993] cally as halogenated phenyl alkane (PMN P-89–867) is subject to reporting § 721.537 Organosilane ester. under this section for the significant (a) Chemical substance and significant new uses described in paragraph (a)(2) new uses subject to reporting. (1) The of this section. The requirements of chemical substance identified generi- this section do not apply once the sub- cally as an organosilane ester (PMN P-

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96–1661/P-95–1654) is subject to reporting final report of each study and all un- under this section for the significant derlying data (‘‘the report and data’’) new uses described in paragraph (a)(2) to EPA no later than 14 weeks prior to of this section. exceeding the applicable production (2) The significant new uses are: volume limit. The final report shall (i) Industrial, commercial, and con- contain the contents specified in 40 sumer activities. Requirements as speci- CFR 792.185. fied in § 721.80(r) (370,000 kilogram (kg)) (D)(1) Except as described in para- (90-day subchronic inhalation study in graph (a)(2)(i)(D)(2) of this section, if, rats-(40 CFR 799.9346) (62 FR 43828, Au- within 6 weeks of EPA’s receipt of a gust 15, 1997) (FRL–5719–5). A person test report and data, the person re- may not manufacture or import the ceives written notice that EPA finds substance beyond the aggregate pro- that the data generated by a study are duction volume limit, unless that per- scientifically invalid, the person is pro- son conducts this study on the sub- hibited from further manufacture and stance and submits all final reports import of the PMN substance beyond and underlying data in accordance with the applicable production volume the procedures and criteria specified in limit. paragraphs (a)(2)(i)(A), (a)(2)(i)(B), (2) The person may continue to man- (a)(2)(i)(C), and (a)(2)(i)(D) of this sec- ufacture and import the PMN sub- tion. stance beyond the applicable produc- (A) Each study required to be per- tion limit only if so notified, in writ- formed pursuant to this section must ing, by EPA in response to the person’s be scientifically valid. Scientific valid compliance with either of the following means that the study was conducted paragraphs (a)(2)(i)(D)(2)(i) or according to: (a)(2)(i)(D)(2)(ii) of this section. (1) The test guidelines specified in (i) The person may reconduct the paragraph (a)(2)(i) of this section. study. If there is sufficient time to re- (2) An EPA-approved protocol. conduct the study and submit the re- (3) TSCA Good Laboratory Practice port and data to EPA at least 14 weeks Standards at 40 CFR part 792. before exceeding the production limit (4) Using methodologies generally ac- as required by paragraph (a)(2)(i)(C)(3) cepted at the time the study is initi- of this section, the person shall comply ated. with paragraph (a)(2)(i)(C)(3) of this (5) Any deviation from these require- section. If there is insufficient time for ments must be approved in writing by the person to comply with paragraph EPA. (a)(2)(ii)(C)(3) of this section, the per- (B) Before starting to conduct any of son may exceed the production limit the studies in paragraph (a)(2)(i) of this and shall submit the report and data in section, the person must obtain ap- triplicate to EPA within a reasonable proval of test protocols from EPA by period of time, all as specified by EPA submitting written protocols. EPA will in the notice described in paragraph respond to the person within 4 weeks of (a)(2)(i)(D)(1) of this section. EPA will receiving the written protocols. Pub- respond to the person in writing, with- lished test guidelines specified in para- in 6 weeks of receiving the person’s re- graph (a)(2)(i) of this section (e.g., 40 port and data. CFR part 797 or part 798) provide gen- (ii) The person may, within 4 weeks eral guidance for development of test of receiving from EPA the notice de- protocols, but are not themselves ac- scribed in paragraph (a)(2)(i)(D)(1) of ceptable protocols. this section, submit to EPA a written (C) The person shall: report refuting EPA’s finding. EPA will (1) Conduct each study in good faith respond to the person in writing, with- with due care. in 4 weeks of receiving the person’s re- (2) Promptly furnish to EPA the report. sults of any interim phase of each (E) The person is not required to con- study. duct a study specified in paragraph (3) Submit, in triplicate (with an ad- (a)(2)(i) of this section if notified in ditional sanitized copy, if confidential writing by EPA that it is unnecessary business information is involved), the to conduct that study.

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(ii) [Reserved] ondary wastewater treatment with (b) Specific requirements. The provi- control of suspended solids, before re- sions of subpart A of this part apply to lease, then the amount of the sub- this section except as modified by this stance reasonably likely to be removed paragraph. from the waste stream by such treat- (1) Recordkeeping. Recordkeeping re- ment may be subtracted in calculating quirements as specified in § 721.125 (a), the number of kilograms released. No (b), (c) and (i) are applicable to manu- more than 95 percent removal effi- facturers, importers, and processors of ciency may be attributed to such treat- this substance. ment. These requirements do not apply (2) Limitations or revocation of certain to the sites specifically exempted in notification requirements. The provisions the TSCA section 5(e) consent order for of § 721.185 apply to this section. this substance. [63 FR 3419, Jan. 22, 1998] (b) Specific requirements. The provisions of subpart A of this part apply to § 721.538 Phenol, 4-(1,1-dimethyl- this section except as modified by this ethyl)-, homopolymer. paragraph. (a) Chemical substance and significant (1) Recordkeeping. Recordkeeping renew uses subject to reporting. (1) The quirements as specified in § 721.125 (a), chemical substance identified as phe- (b), (c), (f), (g), (h), (i), and (k) are ap- nol, 4-(1,1-dimethylethyl)-, plicable to manufacturers, importers, homopolymer (PMN P-95–243; CAS No. and processors of this substance. 30813–81–1) is subject to reporting under (2) Limitations or revocation of certain this section for the significant new notification requirements. The provisions uses described in paragraph (a)(3) of of § 721.185 apply to this section. this section. (3) Determining whether a specific use is (2) High moleculation weight exemption. subject to this section. The provisions of A batch of the chemical substance may § 721.1725(b)(1) apply to this section. be exempt from the provisions of this [63 FR 3420, Jan. 22, 1998] rule if the average number molecular weight of the substance is greater than § 721.539 Poly(oxy-1,2-ethanediyl), α- 1,000 and the low molecular weight spe- sulfo-w-[1-[(4-nonylphenoxy)methyl]- cies below 1,000 and 500 are less than 25 2-(2-propenyloxy)ethoxy]-, percent and 10 percent, respectively. To branched, ammonium salts. be eligible for this exemption, the (a) Chemical substance and significant batch must be individually measured. new uses subject to reporting. (1) The (3) The significant new uses are: chemical substance identified as (i) Hazard communication program. Re- Poly(oxy-1,2-ethanediyl), a-sulfo-w-[1- quirements as specified in § 721.72 (a), [(4-nonylphenoxy)methyl]-2-(2- (b), (d), (f), (g)(3)(i), (g)(4)(i), and (g)(5). propenyloxy)ethoxy]-, branched, am- The label and material safety data monium salts (PMN P-96–1240; CAS No. sheet (MSDS) as required by this para- 184719–88–8) is subject to reporting graph shall also include the following under this section for the significant statement: This substance is toxic to new uses described in paragraph (a)(2) aquatic invertebrate. of this section. (ii) Industrial, commercial, and con- (2) The significant new uses are: sumer activites. Requirements as speci- (i) Industrial, commercial, and con- fied in § 721.80(q). sumer activities. Requirements as speci- (iii) Release to water. Requirements as fied in § 721.80(f). specified in § 721.90 (a)(4) and (b)(4) (N = (ii) [Reserved] 9). When calculating the surface water (b) Specific requirements. The provi- concentrations according to the in- sions of subpart A of this part apply to structions in § 721.91, the statement this section except as modified by this that the amount of the substance that paragraph. will be released will be calculated be- (1) Recordkeeping. Recordkeeping re- fore the substance enters control tech- quirements as specified in § 721.125 (a) nology does not apply. Instead, if the and (i) are applicable to manufactur- waste stream containing the substance ers, importers, and processors of this will be treated using primary and sec- substance.

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(2) Limitations or revocation of certain (b), (c), and (i) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this substance. (2) Limitations or revocation of certain [63 FR 3420, Jan. 22, 1998] notification requirements. The provisions § 721.540 Alkylphenoxypolyalkoxy- of § 721.185 apply to this section. amine (generic name). (3) Determining whether a specific use is subject to this section. The provisions of (a) Chemical substances and significant § 721.1725(b)(1) apply to this section. new uses subject to reporting. (1) The chemical substance identified generi- [65 FR 81398, Dec. 26, 2000] cally as akylphenoxypolyalkoxyamine (PMN P-86–1489) is subject to reporting § 721.550 Alkyl alkenoate, azobis-. under this section for the significant (a) Chemical substance and significant new uses described in paragraph (a)(2) new uses subject to reporting. (1) The of this section. chemical substance identified generi- (2) The significant new uses are: cally as alkyl alkenoate, azobis- (PMN (i) Hazard communication program. Re- P-88–2470) is subject to reporting under quirements as specified in § 721.72 (b)(2), this section for the significant new (c), (f), and (g)(3)(ii), (g)(4)(iii), and uses described in paragraph (a)(2) of (g)(5). this section. (ii) Release to water. Section 721.90 (2) The significant new uses are: (a)(1), (b)(1), and (c)(1). (i) Protection in the workplace. Re- (b) Specific requirements. The provi- quirements as specified in § 721.63 (a)(1), sions of subpart A of this part apply to (a)(3), (a)(4), (a)(5)(i) through (a)(5)(iii), this section except as modified by this (a)(6)(ii), (b) (concentration set at 1.0 paragraph. percent), and (c). (1) Recordkeeping. The following rec- (ii) Hazard communication program. ordkeeping requirements are applicable Requirements as specified in § 721.72 to manufacturers, importers, and proc- (b)(2), (d), (e) (concentration set at 1.0 essors of this substance, as specified in percent), (f), (g)(1)(iii), (g)(2)(i), § 721.125 (f), (g), (h), and (k). (g)(2)(ii), (g)(2)(iii), (g)(2)(v), and (g)(5). (2) Limitations or revocation of certain The provisions of § 721.72(d) requiring requirements. The provisions of § 721.185 employees to be provided with informa- apply to this significant new use rule. tion on the location and availability of [55 FR 26097, June 26, 1990. Redesignated at 58 a written hazard communication pro- FR 29946, May 24, 1993, as amended at 58 FR gram and MSDSs do not apply when 34204, June 23, 1993] the written program and MSDS are not required under § 721.72 (a) and (c), re- § 721.545 Polyalkenylalkylphenol (ge- spectively. The provision of § 721.72(g) neric). requiring placement of specific infor- (a) Chemical substance and significant mation on an MSDS does not apply new uses subject to reporting. (1) The when an MSDS is not required under chemical substance identified generi- § 721.72(c). cally as a Polyalkenylalkylphenol (iii) Industrial, commercial, and con- (PMN P-99–0472) is subject to reporting sumer activities. Requirements as speci- under this section for the significant fied in § 721.80 (l) and (q). new use described in paragraph (a)(2) of (b) Specific requirements. The provi- this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Industrial, commercial, and con- paragraph. sumer activities. Requirements as speci- (1) Recordkeeping. The following rec- fied in § 721.80(j). ordkeeping requirements are applicable (ii) [Reserved] to manufacturers, importers, and proc- (b) Specific requirements. The provi- essors of this substance, as specified in sions of subpart A of this part apply to § 721.125 (a), (b), (c), (e), (f), (g), and (h). this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this significant new quirements as specified in § 721.125 (a), use rule.

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(3) Determining whether a specific use is (i) Release to water. Requirements as subject to this section. The provisions of specified in § 721.90 (a)(1), (b)(1), and § 721.1725(b)(1) apply to this section. (c)(1). (ii) [Reserved] [55 FR 46771, Nov. 6, 1990. Redesignated and amended at 58 FR 29946, May 24, 1993; 58 FR (b) Specific requirements. The provi- 34204, June 23, 1993] sions of subpart A of this part apply to this section except as modified by this § 721.555 Alkyl amino nitriles (ge- paragraph. neric). (1) Recordkeeping. Recordkeeping re- (a) Chemical substance and significant quirements as specified in § 721.125 (a), new uses subject to reporting. (1) The (b), (c), and (k) are applicable to manu- chemical substances identified generi- facturers, importers, and processors of cally as alkyl amino nitriles (PMNs P- this substance. 96–1674 and P-96–1675) are subject to re- (2) Limitations or revocation of certain porting under this section for the sig- notification requirements. The provisions nificant new uses described in para- of § 721.185 apply to this section. graph (a)(2) of this section. [63 FR 44575, Aug. 20, 1998] (2) The significant new uses are: (i) Protection in the workplace. Re- § 721.562 Substituted alkylamine salt. quirements as specified in § 721.63 (a) Chemical substance and significant (a)(2)(iii), (a)(4), (a)(5)(i), new uses subject to reporting. (1) The (a)(6)(ii),(a)(6)(v), and (c). A full face chemical substance identified generi- shield is required if splashing or spray- cally as a substituted alkylamine salt ing occurs. (PMN P-85–941) is subject to reporting (ii) Hazard communication program. under this section for the significant Requirements as specified in § 721.72 new uses described in paragraph (a)(2) (c)(1) and (c)(2)(iv). The MSDS required of this section. by this paragraph shall include the fol- (2) The significant new uses are: lowing statement: Ocular exposure (i) Release to water. Requirements as may cause death. specified in § 721.90 (a)(4), (b)(4), and (iii) Industrial, commercial, and con- (c)(4) (where n = 70). sumer activities. Requirements as speci- (ii) [Reserved] fied in § 721.80 (g) and (l). (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (b), (c), (d), (h), and (i) are applicable to facturers, importers, and processors of manufacturers, importers, and proc- this substance. essors of this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [60 FR 45080, Aug. 30, 1995] [63 FR 65709, Nov. 30, 1998] § 721.575 Substituted alkyl halide. § 721.558 Salt of a fatty alkylamine de- (a) Chemical substance and significant rivative (generic). new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as substituted alkyl halide (PMN chemical substance identified generi- P-83–1222) is subject to reporting under cally as a salt of a fatty alkylamine de- this section for the significant new rivative (PMN P-96–1426) is subject to uses described in paragraph (a)(2) of reporting under this section for the sig- this section. nificant new uses described in para- (2) The significant new uses are: graph (a)(2) of this section. (i) Protection in the workplace. Re- (2) The significant new uses are: quirements as specified in § 721.63 (a)(1),

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(a)(3), (a)(4), (a)(5)(i) through (a)(5)(iii), (ii) Hazard communication program. (a)(6)(v), (a)(6)(vi), (b) (concentration Requirements as specified in § 721.72 (a), set at 0.1 percent), and (c). (b)(2), (c), (d), (e), (f) [concentration set (ii) Hazard communication program. at 1 percent], (g)(1)(iii), (g)(1) (may be Requirements as specified in § 721.72 (d), lethal if inhaled or in contact with (e) (concentration set at 0.1 percent), eyes), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (f), (g)(1)(ii), (g)(1)(vii), (g)(2)(i), (g)(2)(v), and (g)(5). The provision of (g)(2)(ii), (g)(2)(iv), and (g)(2)(v). The § 721.72(d) requiring that employees be provisions of § 721.72(d) requiring em- provided with information on the loca- ployees to be provided with information and availability of MSDSs does tion on the location and availability of not apply when an MSDS is not re- a written hazard communication pro- quired under § 721.72(c). The provision gram and MSDSs do not apply when of § 721.72(g) requiring placement of the written program and MSDS are not specific information on an MSDS does required under § 721.72 (a), and (c), re- not apply when an MSDS in not respectively. The provisions of § 721.72(g) quired under § 721.72(c). requiring placement of specific infor- (iii) Industrial, commercial, and con- mation on a label and MSDS do not sumer activities. Requirements as speci- apply when a label and MSDS are not fied in § 721.80(j). required under § 721.72 (b), and (c), re- (b) Specific requirements. The provi- spectively. sions of subpart A of this part apply to (iii) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80(h). (1) Recordkeeping. The following rec- (b) Specific requirements. The provi- ordkeeping requirements are applicable sions of subpart A of this part apply to to manufacturers, importers, and proc- this section except as modified by this essors of this substance, as specified in paragraph. § 721.125 (a) through (i), and (k). (1) Recordkeeping. The following rec- (2) Limitations or revocation of certain ordkeeping requirements are applicable notification requirements. The provisions to manufacturers, importers, and proc- of § 721.185 apply to this section. essors of this substance, as specified in [55 FR 26102, June 26, 1990. Redesignated at 58 § 721.125 (a), (b), (c), (e), and (f). FR 29947, May 24, 1993, as amended at 58 FR (2) Limitations or revocation of certain 34204, June 23, 1993] notification requirements. The provisions of § 721.185 apply to this significant new § 721.625 Alkylated diarylamine, sul- use rule. furized (generic name). [55 FR 46772, Nov. 6, 1990. Redesignated at 58 (a) Chemical substance and significant FR 29946, May 24, 1993, as amended at 58 FR new uses subject to reporting. (1) The 34204, June 23, 1993] chemical substance identified generically as alkylated diarylamine, sul- § 721.600 3-Alkyl-2-(2-anilino)vinyl thi- furized (PMN P-89–506) is subject to re- azolinium salt (generic name). porting under this section for the sig- (a) Chemical substances and significant nificant new uses described in para- new uses subject to reporting. (1) The graph (a)(2) of this section. chemical substance identified generi- (2) The significant new uses are: cally as 3-alkyl-2-(2-ani- (i) Industrial, commercial, and con- lino)vinylthiazolinium salt (PMN P-84– sumer activities. Requirements as speci- 1007) is subject to reporting under this fied in § 721.80(q) section for the significant new uses de- (ii) [Reserved] scribed in paragraph (a)(2) of this sec- (b) Specific requirements. The provi- tion. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Protection in the workplace. Re- paragraph. quirements as specified in § 721.63 (a)(1), (1) Recordkeeping. The following rec- (a)(3), (a)(4), (a)(5)(iii), (a)(5)(iv), ordkeeping requirements are applicable (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(6)(i), to manufacturers, importers, and proc- (b) (concentration set at 1 percent), and essors of this substance, as specified in (c). § 721.125 (a), (b), and (c).

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(2) Limitations or revocation of certain New Chemical Exposure Limit (NCEL) notification requirements. The provisions provisions listed in the section TSCA of § 721.185 apply to this significant new 5(e) consent order for these substances. use rule. The NCEL is 0.1 mg/m3 as an 8-hour (3) Determining whether a specific use is time weighted average verified by ac- subject to this section. The provisions of tual monitoring data. § 721.1725(b)(1) apply to this section. (ii) Hazard communication program. [55 FR 26099, June 26, 1990. Redesignated and Requirements as specified in § 721.72 (a), amended at 58 FR 29946, May 24, 1993; 58 FR (b), (c), (d), (g)(1)(ii), (g)(1)(iv), (g)(1) 34204, June 23, 1993] (vii), (g)(2)(i), (g)(2)(iv), and (g)(5). (iii) Industrial, commercial, and con- § 721.630 Salt of a modified tallow sumer activities. Requirements as speci- alkylenediamine (generic). fied in § 721.80(q). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as a salt of a modified tallow paragraph. alkylenediamine (PMN P-96–1425) is (1) Recordkeeping. Recordkeeping re- subject to reporting under this section quirements as specified in § 721.125 (a), for the significant new uses described (b), (c), (d), (f), (g), (h), and (i) are appli- in paragraph (a)(2) of this section. cable to manufacturers, importers, and (2) The significant new uses are: processors of this substance. (i) Release to water. Requirements as (2) Limitations or revocation of certain specified in § 721.90 (a)(1), (b)(1), and notification requirements. The provisions (c)(1). of § 721.185 apply to this section. (ii) [Reserved] (3) Determining whether a specific use is (b) Specific requirements. The provi- subject to this section. The provisions of sions of subpart A of this part apply to § 721.1725(b)(1) apply to this section. this section except as modified by this paragraph. [65 FR 81398, Dec. 26, 2000] (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), § 721.633 Aluminosilicates, phospho-. (b), (c), and (k) are applicable to manu- (a) Chemical substance and significant facturers, importers, and processors of new uses subject to reporting. (1) The this substance. chemical substance identified as (2) Limitations or revocation of certain Aluminosilicates, phospho- (PMN P-98– notification requirements. The provisions 1275; CAS No. 201167–69–3) is subject to of § 721.185 apply to this section. reporting under this section for the sig- [63 FR 44575, Aug. 20, 1998] nificant new uses described in paragraph (a)(2) of this section. § 721.632 Silicoaluminophosphates, (2) The significant new uses are: compd. with organic amine (ge- (i) Protection in the workplace. Re- neric). quirements as specified in § 721.63 (a)(4), (a) Chemical substance and significant (a)(5)(i), (b), and (c). As an alternative new uses subject to reporting. (1) The to the respiratory requirements listed chemical substances identified generi- here, a manufacturer, importer, or cally as Silicoaluminophosphates, processor may choose to follow the compd. with organic amine (PMN P-98– NCEL provisions listed in the TSCA 1274) is subject to reporting under this section 5(e) consent order for these subsection for the significant new uses de- stances. The NCEL is 0.1 mg/m3 as an 8- scribed in paragraph (a)(2)of this sec- hour time weighted average verified by tion. actual monitoring data. (2) The significant new uses are: (ii) Hazard communication program. (i) Protection in the workplace. Re- Requirements as specified in § 721.72 (a), quirements as specified in § 721.63 (a)(4), (b), (c), (d), (g)(1)(ii), (g)(1)(iv), (g)(1) (a)(5)(i), (b) and (c). As an alternative (vii), (g)(2)(i), (g)(2)(iv), and (g)(5). to the respiratory requirements listed (iii) Industrial, commercial, and con- here, a manufacturer, importer, or sumer activities. Requirements as speci- processor may choose to follow the fied in § 721.80(q).

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(b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(1), (b)(1), and this section except as modified by this (c)(1). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), (d), (f), (g), (h), and (i) are appli- this section except as modified by this cable to manufacturers, importers, and paragraph. processors of this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of this substance. (3) Determining whether a specific use is (2) Limitations or revocation of certain subject to this section. The provisions of notification requirements. The provisions § 721.1725(b)(1) apply to this section. of § 721.185 apply to this section. [65 FR 81399, Dec. 26, 2000] [60 FR 45080, Aug. 30, 1995]

§ 721.638 Silyl amine, potassium salt § 721.640 Amine substituted metal (generic). salts. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substances identified generically as silyl amine, potassium salt cally as amine substituted metal salts (PMN P-00–1086) is subject to reporting (PMNs P-96–1337/1338/1339) are subject under this section for the significant to reporting under this section for the new use described in paragraph (a)(2) of significant new uses described in para- this section. graph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Release to water. Requirements as (i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and specified in § 721.90 (a)(4), (b)(4), and (c)(1). (c)(4) (N = 4). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of these substances. this substance. (2) Limitations or revocation of certain (2) Limitation or revocation of certain notification requirements. The provisions The provisions notification requirements. of § 721.185 apply to this section. of § 721.185 apply to this section. [63 FR 3421, Jan. 22, 1998] [68 FR 15080, Mar. 28, 2003] § 721.641 Alkylpoly(oxyalkylene)amine. § 721.639 Amine aldehyde condensate. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified generically as an cally as an amine aldehyde condensate alkylpoly(oxyalkylene)amine (PMN P- (PMN P-94–1810) is subject to reporting 96–1430) is subject to reporting under under this section for the significant this section for the significant new new uses described in paragraph (a)(2) uses described in paragraph (a)(2) of of this section. this section. (2) The significant new uses are: (2) The significant new uses are:

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(i) Industrial, commercial, and con- to reporting under this section for the sumer activities. Requirements as speci- significant new uses described in para- fied in § 721.80(g). graph (a)(2) of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(4), (b)(4), and this section except as modified by this (c)(4) (N = 8). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), and (i) are applicable to manu- this section except as modified by this facturers, importers, and processors of paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of [63 FR 3421, Jan. 22, 1998] this substance. (2) Limitations or revocation of certain § 721.642 Amines, N-(C14-18 and C16-16 notification requirements. The provisions unsaturated alkyl)] dipropylene-tri-, of § 721.185 apply to this section. tripropylenetetra-, and tetrapropylenepenta-. [63 FR 3421, Jan. 22, 1998] (a) Chemical substances and significant § 721.644 Amines, C12-14-tert-alkyl, new uses subject to reporting. (1) The sulfonates. chemical substances amines, N-(C 14–18 (a) Chemical substance and significant and C16–18 unsaturated alkyl)] dipropylenetri-, (PMN P-94–1244), new uses subject to reporting. (1) The tripropylenetetra- (PMN P-94–1245), and chemical substance identified as tetrapropylenepenta- (PMN P-94–1246) amines, C12-14-tert-alkyl, sulfonates are subject to reporting under this sec- (PMN P-98–400; CAS No. 197527–19–8) is tion for the significant new uses de- subject to reporting under this section scribed in paragraph (a)(2) of this sec- for the significant new use described in tion. paragraph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Release to water. Requirements as (i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and specified in § 721.90 (a)(1), (b)(1), and (c)(1). (c)(1). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping requirements. Rec- (1) Recordkeeping. Recordkeeping re- ordkeeping requirements specified in quirements as specified in § 721.125 (a), § 721.125 (a), (b), (c), and (k) are applica- (b), (c), and (k) are applicable to manu- ble to manufacturers, importers, and facturers, importers, and processors of processors of this substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [60 FR 11041, Mar. 1, 1995] [65 FR 366, Jan. 5, 2000]

§ 721.643 Ethoxylated alcohol, § 721.646 Aminofluoran derivative (ge- phosphated, amine salt. neric name). (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified as an chemical substance identified generi- ethoxylated alcohol, phosphated, cally as aminofluoran derivative (PMN amine salt (PMN P-96–1478) is subject P-95–512) is subject to reporting under

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this section for the significant new chemical substance identified generi- uses described in paragraph (a)(2) of cally as alkyl dialkylamino this section. phenylsulfonyl alkenoate (PMN P-00– (2) The significant new uses are: 0816) is subject to reporting under this (i) Industrial, commercial, and con- section for the significant new use de- sumer activities. Requirements as speci- scribed in paragraph (a)(2) of this sec- fied in § 721.80(f). tion. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Requirements as speci- this section except as modified by this fied in § 721.80(f). paragraph. (ii) Release to water. Requirements as (1) Recordkeeping. Recordkeeping re- specified in § 721.90 (a)(1), (b)(1), and quirements as specified in § 721.125 (a), (c)(1). (b), (c), and (i) are applicable to manu- (b) Specific requirements. The provi- facturers, importers, and processors of sions of subpart A of this part apply to this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), [61 FR 63735, Dec. 2, 1996] (b), (c), (i), and (k) are applicable to manufacturers, importers, and proc- § 721.647 Alkoxylated alkyl amine (ge- essors of this substance. neric). (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generi- [68 FR 15080, Mar. 28, 2003] cally as an alkoxylated alkyl amine (PMN P-01–578) is subject to reporting § 721.650 11-Aminoundecanoic acid. under this section for the significant (a) Chemical substance and significant new use described in paragraph (a)(2) of new use subject to reporting. (1) The this section. chemical substance 11-aminoundeca- (2) The significant new uses are: noic acid, CAS Number 2432–99–7, is (i) Industrial, commercial, and con- subject to reporting under this section sumer activities. Requirements as speci- for the significant new use described in fied in § 721.80(j). paragraph (a)(2) of this section. (ii) [Reserved] (2) The significant new use is any use (b) Specific requirements. The provi- other than as. sions of subpart A of this part apply to (i) An intermediate in the manufac- this section except as modified by this ture of polymers in an enclosed process paragraph. when it is expected that the 11- (1) Recordkeeping. Recordkeeping re- aminoundecanoic acid will be fully po- quirements as specified in § 721.125(a), lymerized during the manufacturing (b), (c), and (i) are applicable to manu- process, or facturers, importers, and processors of (ii) A component in photoprocessing this chemical substance. solutions. (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of Subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this (3) Determining whether a specific use is paragraph. subject to this section. The provisions of (1) Definitions. In addition to the defi- § 721.1725(b)(1) apply to this section. nitions in § 721.3, the following defini- [68 FR 70174, Dec. 17, 2003] tions apply to this section: (i) Enclosed process means a process § 721.648 Alkyl dialkylamino that is designed and operated so that phenylsulfonyl alkenoate (generic). there is no intentional release of any (a) Chemical substance and significant substance present in the process. A new uses subject to reporting. (1) The process with fugitive, inadvertent, or

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emergency pressure relief releases re- this section except as modified by this mains an enclosed process so long as paragraph. measures are taken to prevent worker (1) Recordkeeping. Recordkeeping re- exposure to and environmental con- quirements as specified in § 721.125 (a), tamination from the releases. (b), (c), and (i) are applicable to manu- (ii) Internal subunit means a subunit facturers, importers, and processors of that is covalently linked to at least this substance. two other subunits. Internal subunits of (2) Limitations or revocation of certain polymer molecules are chemically de- notification requirements. The provisions rived from monomer molecules that of § 721.185 apply to this section. have formed covalent links between two or more other molecules. [63 FR 3421, Jan. 22, 1998] (iii) Monomer means a chemical substance that has the capacity to form § 721.715 Trisubstituted anthracene. links between two or more other mol- (a) Chemical substance and significant ecules. new uses subject to reporting. (1) The (iv) Polymer means a chemical sub- chemical substance identified generi- stance that consists of at least a sim- cally as trisubstituted anthracene ple weight majority of polymer mol- (PMN P-91–689) is subject to reporting ecules but consists of less than a sim- under this section for the significant ple weight majority of molecules with new uses described in paragraph (a)(2) the same molecular weight. Collec- of this section. tively, such polymer molecules must (2) The significant new uses are: be distributed over a range of molecular weights wherein differences in mo- (i) Protection in the workplace. Re- lecular weight are primarly attrib- quirements as specified in § 721.63 (a)(1), utable to differences in the number of (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), internal subunits. (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (v) Polymer molecule means a mol- (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (con- ecule which includes at least four centration set at 0.1 percent), and (c). covalently linked subunits, at least (ii) Hazard communication program. two of which are internal subunits. Requirements as specified in § 721.72 (a), (vi) Subunit means an atom or group (b), (c), (d), (e) (concentration set 0.1 of associated atoms chemically derived percent), (f), (g)(1)(vii), (g)(2)(i), from corresponding reactants. (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (2) [Reserved] (g)(3)(ii), (g)(4)(i), and (g)(5). (iii) Industrial, commercial, and con- [52 FR 19865, May 28, 1987. Redesignated at 53 FR 2845, Feb. 2, 1988. Further redesignated at sumer activities. Requirements as speci- 58 FR 29946, May 24, 1993] fied in § 721.80(p) (First limit set at 500 kg; second limit set at 25,000 kg). § 721.655 Ethoxylated alkyl quaternary (iv) Release to water. Requirements as ammonium compound. specified in § 721.90 (a)(4), (b)(4), and (a) Chemical substance and significant (c)(4) (where N = 10 ppb). new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substance identified generi- sions of subpart A of this part apply to cally as an ethoxylated alkyl quater- this section except as modified by this nary ammonium compound (PMN P-96– paragraph. 573) is subject to reporting under this (1) Recordkeeping. Recordkeeping re- section for the significant new uses de- quirements as specified in § 721.125 (a) scribed in paragraph (a)(2) of this sec- through (i) and (k) are applicable to tion. manufacturers, importers, and proc- (2) The significant new uses are: essors of this substance. (i) Industrial, commercial and consumer (2) Limitations or revocation of certain activities. Requirements as specified in notification requirements. The provisions § 721.80(j). of § 721.185 apply to this section. (ii) [Reserved] (b) Specific requirements. The provi- [59 FR 27481, May 27, 1994] sions of subpart A of this part apply to

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§ 721.720 Alkoxylated fatty acid amide, apply when a label and MSDS are not alkylsulfate salt. required under § 721.72 (b) and (c), re- (a) Chemical substance and significant spectively. new uses subject to reporting. (1) The (iii) Industrial, commercial, and con- chemical substance identified generi- sumer activities. Requirements as speci- cally as an alkoxylated fatty acid fied in § 721.80(g). amide, alkylsulfate salt (PMN P-97–136) (b) Specific requirements. The provi- is subject to reporting under this sec- sions of subpart A of this part apply to tion for the significant new uses de- this section except as modified by this scribed in paragraph (a)(2) of this sec- paragraph. tion. (1) Recordkeeping. The following rec- (2) The significant new uses are: ordkeeping requirements are applicable (i) Industrial, commercial, and con- to manufacturers, importers, and proc- sumer activities. Requirements as speci- essors of this substance, as specified in fied in § 721.80(l). § 721.125 (a), (b), (c), (e) and (f). (ii) [Reserved] (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this significant new this section except as modified by this use rule. paragraph. [55 FR 39899, Sept. 28, 1990. Redesignated at (1) Recordkeeping. Recordkeeping re- 58 FR 29946, May 24, 1993, as amended at 58 quirements as specified in § 721.125 (a), FR 34204, June 23, 1993] (b), (c) and (i) are applicable to manufacturers, importers, and processors of § 721.757 Polyoxyalkylene substituted this substance. aromatic azo colorant. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generi- [63 FR 3422, Jan. 22, 1998] cally as polyoxyalkylene substituted aromatic azo colorant (PMN P-92–1131) § 721.750 Aromatic amine compound. is subject to reporting under this sec- (a) Chemical substance and significant tion for the significant new uses de- new uses subject to reporting. (1) The scribed in paragraph (a)(2) of this sec- chemical substance aromatic amine tion. compound (PMN P-86–334) is subject to (2) The significant new uses are: reporting under this section for the sig- (i) Industrial, commercial, and con- nificant new uses described in para- sumer activities. Requirements as speci- graph (a)(2) of this section. fied in § 721.80 (w)(1) and (w)(2). (2) The significant new uses are: (ii) [Reserved] (i) Protection in the workplace. Re- (b) Specific requirements. The provi- quirements as specified in § 721.63 (a)(1), sions of subpart A of this part apply to (a)(3), (b) (concentration set at 0.1 per- this section except as modified by this cent) and (c). paragraph. (ii) Hazard communication program. (1) Recordkeeping. Recordkeeping re- Requirements as specified in § 721.72 quirements as specified in § 721.125 (a), (b)(2), (d), (e) (concentration set at 0.1 (b), (c), and (i) are applicable to manu- percent), (f), (g)(1)(iv), (g)(1)(vii), facturers, importers, and processors of (g)(2)(i) through (g)(2)(iii), and (g)(2)(v). this substance. The provisions of § 721.72(d) requiring (2) Limitations or revocation of certain employees to be provided with informa- notification requirements. The provisions tion on the location and availability of of § 721.185 apply to this section. a written hazard communication program and MSDSs do not apply when [58 FR 51681, Oct. 4, 1993] the written program and MSDS are not required under § 721.72 (a) and (c), re- § 721.775 Brominated aromatic com- spectively. The provisions of § 721.72(g) pound (generic name). requiring placement of specific infor- (a) Chemical substances and significant mation on a label and MSDS do not new uses subject to reporting. (1) The

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chemical substance identified generically as a halogenated alkane aromatic cally as a brominated aromatic com- compound (PMN P-94–1747) is subject to pound (PMN P-84–824) is subject to re- reporting under this section for the sig- porting under this section for the significant new uses described in para- nificant new uses described in paragraph (a)(2) of this section. graph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Protection in the workplace. Re- (i) Protection in the workplace. Re- quirements as specified in § 721.63 (a)(1), quirements as specified in § 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), (6)(i), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(iv), (b) (concentration set at 0.1 percent), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(6)(i), and (c). (b) (concentration set at 0.1 percent), (ii) Hazard communication program. and (c). Requirements as specified in § 721.72 (a), (ii) Hazard communication program. (b), (c), (d), (e) (concentration set at 0.1 Requirements as specified in § 721.72 (a), percent), (g)(1)(vii), (g)(2)(iv), (g)(2)(v), (b)(1), (d), (e) (concentration set at 0.1 (g)(3)(ii), (g)(4)(iii), and (g)(5). percent), (f), (g)(1)(i), (g)(1)(vii), (iii) Industrial, commercial, and con- (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), sumer activites. Requirements as speci- and (g)(2)(v). The provision of § 721.72(d) fied in § 721.80(q). requiring that employees be provided (iv) Release to water. Requirements as with information on the location and specified in § 721.90 (a)(1), (b)(1), and availability of MSDSs does not apply (c)(1). when an MSDS is not required under (b) Specific requirements. The provi- § 721.72(c). The provision of § 721.72(g) sions of subpart A of this part apply to requiring placement of specific infor- this section except as modified by this mation on an MSDS does not apply paragraph. when an MSDS in not required under (1) Recordkeeping. Recordkeeping re- § 721.72(c). quirements as specified in § 721.125 (a), (iii) Industrial, commercial, and con- (b), (c), (d), (e), (f), (g), (h), (i), and (k) Requirements as speci- sumer activities. are applicable to manufacturers, im- fied in § 721.80 (j) (use as an additive porters, and processors of this sub- flame retardant for plastics) and (q). stance. (iv) Release to water. Requirements as (2) Limitations or revocation of certain specified in § 721.90 (a)(1), (b)(1), and notification requirements. The provisions (c)(1). of § 721.185 apply to this section. (b) Specific requirements. The provisions of subpart A of this part apply to (3) Determining whether a specific use is this section except as modified by this subject to this section. The provisions of paragraph. § 721.1725(b)(1) apply to this section. (1) Recordkeeping. The following rec- [61 FR 63735, Dec. 2, 1996] ordkeeping requirements are applicable to manufacturers, importers, and proc- § 721.805 Benzenamine, 4,4′-[1,3- essors of this substance, as specified in phenylenebis(1-methylethyl § 721.125 (a) through (g), (i), and (k). idene)]bis[2,6-dimethyl-. (2) Determining whether a specific use is (a) Chemical substances and signifi- subject to this section. The provisions of cant new uses subject to reporting. (1) § 721.1725(b)(1) apply to this section. The chemical substance benzenamine, (3) Limitations or revocation of certain 4,4′-[1,3-phenylenebis(1-methyl ethyl- notification requirements. The provisions idene)]bis[2,6-dimethyl- (CAS Registry of § 721.185 apply to this section. Number 2716–12–3; PMN P-86–501) is sub- [55 FR 26098, June 26, 1990. Redesignated and ject to reporting under this section for amended at 58 FR 29946, May 24, 1993; 58 FR the significant new uses described in 34204, June 23, 1993] paragraph (a)(2) of this section. (2) The significant new uses are: § 721.785 Halogenated alkane aromatic (i) Protection in the workplace. Re- compound (generic name). quirements as specified in § 721.63 (a)(1), (a) Chemical substance and significant (a)(3), (a)(4), (a)(5)(iv) through new uses subject to reporting. (1) The (a)(5)(xv), (a)(6)(i), (a)(6)(ii), (b) (con- chemical substance identified generi- centration set at 0.1 percent), and (c).

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(ii) Hazard communication. Require- carboxylate (1:1), reaction products ments as specified in § 721.72 (a), (b)(2), with phthalic anhydride (PMN P-86– (c), (d), (e) (concentration set at 0.1 1153). percent), (f), (g)(1)(iv), (g)(1)(vii), (2) The significant new use for P-85– (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), 335 is: Manufacture, import, or proc- and (g)(5). essing in a quantity of 100,000 pounds (iii) Industrial, commercial, and con- per year, or greater, for any use. sumer activities. Requirements as speci- (3) The significant new use for P-85– fied in § 721.80(l). 336 is: Any use. (iv) Disposal. Requirements as speci- (4) The significant new use for P-86– fied in § 721.85 (a)(1), (b)(1), (c)(1), (a)(2), 1153 is: Manufacture, import, or proc- (b)(2), and (c)(2). essing in a quantity of 225,000 pounds (v) Release to water. Requirements as per year, or greater, for any use. specified in § 721.90 (a)(2)(vi), (b)(2)(vi), (b) Specific requirements. The provi- and (c)(2)(vi). sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Persons who must report. Section paragraph. 721.5 applies to this section except (1) Recordkeeping requirements. Rec- § 721.5(a)(2). A person who intends to ordkeeping requirements as specified manufacture, import, or process for in § 721.125 (a) through (k) are applica- commercial purposes a substance iden- ble to manufacturers, importers, and tified in paragraph (a)(3) of this section processors of these substances . and intends to distribute the substance (2) Limitations or revocation of certain in commerce must submit a significant notification requirements. The provisions new use notice. of § 721.185 apply to this significant new (2) [Reserved] use rule. (3) Determining whether a specific use is [59 FR 43296, Aug. 23, 1994] subject to this section. The provisions of § 721.1725(b)(1) apply to this section. § 721.840 Alkyl substituted diaromatic hydrocarbons. [57 FR 31330, July 15, 1992, as amended at 58 (a) Chemical substance and significant FR 29946, May 24, 1993; 58 FR 34204, June 23, new uses subject to reporting. (1) The 1993] chemical substance identified generi- § 721.825 Certain aromatic ether cally as an alkyl substituted diaro- diamines. matic hydrocarbons (PMN P-91–710) is (a) Chemical substances and significant subject to reporting under this section new uses subject to reporting. (1) The fol- for the significant new uses described lowing chemical substances are subject in paragraph (a)(2) of this section. to reporting under this section for the (2) The significant new uses are: significant new uses described in para- (i) Release to water. Requirements as graphs (a)(2), (a)(3), and (a)(4) of this specified in § 721.90 (a)(1), (b)(1), and section: Benzenamine, 4,4′-[[1,1′- (c)(1). biphenyl]-2,5-diylbis(oxy)]bis- (CAS (ii) [Reserved] Number 94148–67–1, Premanufacture no- (b) Specific requirements. The provi- tice (PMN) P-85–335); 1,2,4,5- sions of subpart A of this part apply to benzenetetracarboxylic acid, diethyl this section except as modified by this ester, compound with 4,4′-[[1,1′- paragraph. biphenyl]-2,5- (1) Recordkeeping requirements. Re- diylbis(oxy)]bis[benzenamine] (1:1) quirements as specified in § 721.125 (a), (PMN P-85–336); and 1,2,4,5- (b), (c), and (k) are applicable to manu- benzenetetracarboxylic acid, 1,4- facturers, importers, and processors of diethyl ester, compound with 4,4′-[[1,1′- this substance. biphenyl]-2,5- (2) Limitations or revocation of certain diylbis(oxy)]bis[benzenamine] (1:1), notification requirements. The provisions polymer with 4,4′-[[1,1′-biphenyl]-2,5- of § 721.185 apply to this section. diylbis(oxy)]bis[benzenamine]-1,5- [57 FR 46464, Oct. 8, 1992, as amended at 58 FR diethyl-1,2,4,5-benzenetetra 34204, June 23, 1993]

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§ 721.843 Substituted label and MSDS do not apply when a phenylazophenylazo phenol (ge- label and MSDS are not required under neric). § 721.72 (b) and (c), respectively. (a) Chemical substance and significant (iii) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified generi- fied in § 721.80(g). cally as substituted (b) Specific requirements. The provi- phenylazophenylazo, phenol (PMN P- sions of subpart A of this part apply to 00–0420) is subject to reporting under this section except as modified by this this section for the significant new use paragraph. described in paragraph (a)(2) of this (1) Recordkeeping. The following rec- section. ordkeeping requirements are applicable (2) The significant new uses are: to manufacturers, importers, and proc- (i) Release to water. Requirements as essors of this substance, as specified in specified in § 721.90 (a)(1), (b)(1), and § 721.125 (a), (b), (c), (e), and (f). (c)(1). (2) Limitations or revocation of certain (ii) [Reserved] notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this significant new sions of subpart A of this part apply to use rule. this section except as modified by this paragraph. [55 FR 39899, Sept. 28, 1990. Redesignated at (1) Recordkeeping. Recordkeeping re- 58 FR 29946, May 24, 1993, as amended at 58 FR 34204, June 23, 1993] quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- § 721.910 Propanetriol facturers, importers, and processors of polyalkylenepolyolamine aryl this substance. aldimine (generic). (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generi- [68 FR 15081, Mar. 28, 2003] cally as propanetriol polyalkylenepolyolamine aryl aldimine § 721.875 Aromatic nitro compound. (PMN P-99–0873) is subject to reporting (a) Chemical substance and significant under this section for the significant new uses subject to reporting. (1) The new use described in paragraph (a)(2) of chemical substance aromatic nitro this section. compound (PMN P-86–335) is subject to (2) The significant new uses are: reporting under this section for the sig- (i) Release to water. Requirements as nificant new uses described in para- specified in § 721.90 (a)(1), (b)(1), and graph (a)(2) of this section. (c)(1). (2) The significant new uses are: (ii) [Reserved] (i) Protection in the workplace. Re- (b) Specific requirements. The provi- quirements as specified in § 721.63 (a)(1), sions of subpart A of this part apply to (a)(3), (a)(4), (a)(5)(iv) through this section except as modified by this (a)(5)(vii), (a)(6)(i), (b) (concentration paragraph. set at 0.1 percent), and (c). (1) Recordkeeping. Recordkeeping re- (ii) Hazard communication program. quirements as specified in § 721.125 (a), Requirements as specified in § 721.72 (d), (b), (c), and (k) are applicable to manu- (e) (concentration set at 0.1 percent), facturers, importers, and processors of (f), (g)(1)(iv), (g)(1)(vii), and (g)(2)(i) this substance. through (g)(2)(v). The provisions of (2) Limitations or revocation of certain § 721.72(d) requiring employees to be notification requirements. The provisions provided with information on the loca- of § 721.185 apply to this section. tion and availability of a written hazard communication program and [68 FR 15081, Mar. 28, 2003] MSDSs do not apply when the written program and MSDS are not required § 721.925 Substituted aromatic (ge- under § 721.72 (a) and (c), respectively. neric). The provisions of § 721.72(g) requiring (a) Chemical substances and significant placement of specific information on a new uses subject to reporting. (1) The

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chemical substance identified generi- (i) Industrial, commercial, and con- cally as a substituted aromatic (PMN sumer activities. Requirements as speci- P-84–954) is subject to reporting under fied in § 721.80 (j) (use as a dye leveler) this section for the significant new and (q). uses described in paragraph (a)(2) of (ii) [Reserved] this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 (a)(1), paragraph. (a)(3), (b) (concentration set at 0.1 per- (1) Recordkeeping. The following rec- cent), and (c). ordkeeping requirements are applicable (ii) Hazard communication program. to manufacturers, importers, and proc- Requirements as specified in § 721.72 (a), essors of this substance, as specified in (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(vii), (g)(2)(i), and § 721.125 (a), (b), (c), and (i). (g)(2)(v). The provision of § 721.72(d) re- (2) Limitations or revocation of certain quiring that employees be provided notification requirements. The provisions with information on the location and of § 721.185 apply to this section. availability of MSDSs does not apply (3) Determining whether a specific use is when an MSDS is not required under subject to this section. The provisions of § 721.72(c). The provisions of § 721.72(g) § 721.1725(b)(1) apply to this section. requiring placement of specific infor- [55 FR 26098, June 26, 1990. Redesignated and mation on a label and MSDS do not amended at 58 FR 29946, May 24, 1993; 58 FR apply when a label and MSDS are not 34204, June 23, 1993] required under § 721.72 (b) and (c), respectively. § 721.977 Aryloxyarene. (iii) Industrial, commercial, and con- (a) Chemical substance and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80(g). (iv) Release to water. Requirements as chemical substance identified generi- specified in § 721.90 (a)(4), (b)(4), and cally as aryloxyarene (PMN P-92–314) is (c)(4) (level set at 0.25 ppm). subject to reporting under this section (b) Specific requirements. The provi- for the significant new uses described sions of subpart A of this part apply to in paragraph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Hazard communication program. Re- (1) Recordkeeping. The following rec- quirements as specified in § 721.72 (a), ordkeeping requirements are applicable (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), and to manufacturers, importers, and proc- (g)(5). The label and MSDS as required essors of this substance, as specified in by this paragraph shall also include the § 721.125 (a) through (i), and (k). following statement: This substance (2) Limitations or revocation of certain may be toxic to sediment organisms. notification requirements. The provisions (ii) Release to water. Requirements as of § 721.185 apply to this section. specified in § 721.90 (a)(1), (b)(1), and [55 FR 26098, June 26, 1990. Redesignated at 58 (c)(1). FR 29946, May 24, 1993, as amended at 58 FR (b) Specific requirements. The provi- 34204, June 23, 1993] sions of subpart A of this part apply to this section except as modified by this § 721.950 Sodium salt of an alkylated, paragraph. sulfonated aromatic (generic name). (1) Recordkeeping. Recordkeeping re- (a) Chemical substances and significant quirements as specified in § 721.125 (a), new uses subject to reporting. (1) The (b), (c), (f), (g), (h), (i), and (k) are ap- chemical substance identified generi- plicable to manufacturers, importers, cally as a sodium salt of an alkylated, and processors of this substance. sulfonated aromatic (PMN P-84–591) is (2) Limitations or revocation of certain subject to reporting under this section notification requirements. The provisions for the significant new uses described of § 721.185 apply to this section. in paragraph (a)(2) of this section. (2) The significant new uses are: [63 FR 3422, Jan. 22, 1998]

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§ 721.980 Sodium salt of azo acid dye. (2) Limitations or revocation of certain notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The chemical substance identified generi- [63 FR 3422, Jan. 22, 1998] cally as a sodium salt of azo acid dye (PMN P-95–633) is subject to eporting § 721.982 Calcium, bis(2,4- under this section for the significant pentanedionato-O,O′). new uses described in paragraph (a)(2) (a) Chemical substance and significant of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance calcium, bis(2,4- (i) Industrial, commercial, and con- pentanedionato-O,O′) (PMN P-93–214, sumer activities. Requirements as speci- CAS no. 19372–44–2) is subject to report- fied in § 721.80 (v)(1), (w)(1), and (x)(1). ing under this section for the signifi- (ii) [Reserved] cant new uses described in paragraph (b) Specific requirements. The provi- (a)(2) of this section. The requirements sions of subpart A of this part apply to of this section do not apply if the sub- this section except as modified by this stance is embedded or encapsulated in paragraph. a plastic matrix. (1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a), (i) Protection in the workplace. Re- (b), (c), and (i) are applicable to manu- quirements as specified in § 721.63 (a)(4), facturers, importers, and processors of this substance. (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (con- (2) Limitations or revocation of certain notification requirements. The provisions centration set a 1.0 percent); and (c). of § 721.185 apply to this section. As an alternative to the respiratory requirements in this section, manufac- [63 FR 3422, Jan. 22, 1998] turers, importers, and processors may use the New Chemical Exposure Limits § 721.981 Substituted naphtholoazo- provisions, including sampling and an- substituted naphthalenyl-substituted azonaphthol chromium alytical methods which have pre- complex. viously been approved by EPA for this substance, found in the 5(e) consent (a) Chemical substance and significant order for this substance. new uses subject to reporting. (1) The chemical substance identified generi- (ii) Hazard communication program. cally as a substituted naphtholoazo- Requirements as specified in § 721.72 (a), substituted naphthalenyl-substituted (b), (c), (d), (e) (concentration set at 1.0 azonaphthol chromium complex (PMN percent), (f), (g)(1)(iii), (g)(1)(ix), P-93–1631) is subject to reporting under (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5). this section for the significant new (iii) Industrial, commercial, and con- uses described in paragraph (a)(2) of sumer activities. Requirements as speci- this section. fied in § 721.80(l). (2) The significant new uses are: (b) Specific requirements. The provi- (i) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Requirements as speci- this section except as modified by this fied in § 721.80 (f), (v)(2), (w)(2), and paragraph. (x)(2). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] quirements as specified in § 721.125 (a) (b) Specific requirements. The provi- through (d), (f) through (h), and (i) are sions of subpart A of this part apply to applicable to manufacturers, import- this section except as modified by this ers, and processors of this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (i) are applicable to manufacturers, importers, and processors of [59 FR 27482, May 27, 1994] this substance.

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§ 721.983 Sulfonyl azide intermediate (2) Limitations or revocation of certain (generic). notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The [68 FR 15081, Mar. 28, 2003] chemical substance identified generically as sulfonyl azide intermediate § 721.987 Dialkylaminophenyl imino (PMN P-99–1202) is subject to reporting pyrazole acid ester (generic). under this section for the significant (a) Chemical substance and significant new use described in paragraph (a)(1) of new uses subject to reporting. (1) The this section. chemical substance identified generi- (2) The significant new uses are: cally as dialkylaminophenyl imino (i) Release to water. Requirements as pyrazole acid ester (PMN P-98–45) is specified in § 721.90(a)(1), (b)(1), and subject to reporting under this section (c)(1). for the significant new uses described (ii) Industrial, commercial, and con- in paragraph (a)(2) of this section. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80(f), (v)(1), and (x)(1). (i) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(1), (b)(1), and sions of subpart A of this part apply to (c)(1). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125(a), this section except as modified by this (b), (c), (i), and (k) are applicable to paragraph. manufacturers, importers, and proc- (1) Recordkeeping. Recordkeeping re- essors of this chemical substance. (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of this substance. [68 FR 70174, Dec. 17, 2003] (2) Limitations or revocation of certain notification requirements. The provisions § 721.984 Amino-hydroxy of § 721.185 apply to this section. sulfonaphthylazo-disubstituted phenyl azo benzene carboxylate salt [63 FR 44575, Aug. 20, 1998] (generic). (a) Chemical substance and significant § 721.988 Pyrazolone azomethine dye new uses subject to reporting. (1) The (generic). chemical substance identified generi- (a) Chemical substance and significant cally as amino-hydroxy new uses subject to reporting. (1) The sulfonaphthylazo-disubstituted phenyl chemical substance identified generi- azo benzene carboxylate salt (PMN P- cally as a pyrazolone azomethine dye 00–0351) is subject to reporting under (PMN P-98–91) is subject to reporting this section for the significant new use under this section for the significant described in paragraph (a)(2) of this new uses described in paragraph (a)(2) section. of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial, and con- (i) Release to water. Requirements as sumer activities. Requirements as speci- specified in § 721.90 (a)(1), (b)(1), and fied in § 721.80 (v)(2), (w)(2), (x)(2). (c)(1). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. this substance.

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(2) Limitations or revocation of certain provided with information on the loca- notification requirements. The provisions tion and availability of MSDSs does of § 721.185 apply to this section. not apply when an MSDS is not re- [63 FR 44575, Aug. 20, 1998] quired under § 721.72(c). The provision of § 721.72(g) requiring placement of § 721.990 1,4-Benzedicarboxylic acid, specific information in an MSDS or dimethyl ester, polymer with 1,4 - label does not apply when an MSDS butanediol, cyclized. and label are not required under (a) Chemical substance and significant § 721.72(c). new uses subject to reporting. (1) The (iii) Industrial, commercial, and con- chemical substance identified as 1,4- sumer activities. Requirements as speci- benzedicarboxylic acid, dimethyl ester, fied in § 720.80(h). polymer with 1,4 - butanediol, cyclized (iv) Disposal. Requirements as speci- (PMN P-00–0789; CAS No. 263244–54–8) is fied in § 721.85 (a)(1), (a)(3), (b)(1), (b)(3), subject to reporting under this section (c)(1), and (c)(3). for the significant new use described in (b) Specific requirements. The provi- paragraph (a)(2) of this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Release to water. Requirements as paragraph. specified in § 721.90 (a)(1), (b)(1), and (1) Recordkeeping. The following rec- (c)(1). ordkeeping requirements are applicable (ii) [Reserved] to manufacturers, importers, and proc- (b) Specific requirements. The provi- essors of this substance, as specified in sions of subpart A of this part apply to § 721.125 (a) through (f), (i), and (j). this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this significant new quirements as specified in § 721.125 (a), use rule. (b), (c), and (k) are applicable to manu- [56 FR 25989, June 5, 1991. Redesignated at 58 facturers, importers, and processors of FR 29946, May 24, 1993, as amended at 58 FR this substance. 34204, June 23, 1993] (2) Limitations or revocation of certain notification requirements. The provisions § 721.1025 Benzenamine, 4-chloro-2- of § 721.185 apply to this section. methyl-; benzenamine, 4-chloro-2- methyl-, hydrochloride; and ben- [68 FR 15081, Mar. 28, 2003] zenamine, 2-chloro-6-methyl-. § 721.1000 Benzenamine, 3-chloro-2,6- (a) Chemical substances and significant dinitro-N,N-dipropyl-4-(trifluoro- new use subject to reporting. (1) The methyl)-. chemical substances benzenamine, 4- (a) Chemical substances and significant chloro-2-methyl- (CAS Number 95–69–2); new uses subject to reporting. (1) The benzenamine, 4-chloro-2-methyl-, hy- chemical substance identified as drochloride (CAS Number 3165–93–3); benzenamine, 3-chloro-2,6-dinitro-N,N- and benzenamine, 2-chloro-6-methyl- dipropyl-4-(trifluoromethyl)- (P-86–83) (CAS Number 87–63–8) are subject to re- is subject to reporting under this sec- porting under this section for the sig- tion for the significant new uses de- nificant new use described in paragraph scribed in paragraph (a)(2) of this sec- (a)(2) of this section. tion. (2) The significant new use is: Any (2) The significant new uses are: use. (i) Protection in the workplace. Re- (b) Specific requirements. The provi- quirements as specified in § 721.63 (a)(1), sions of subpart A of this part apply to (a)(3), (b) (concentration set at 0.1 per- this section except as modified by this cent), and (c). paragraph: (ii) Hazard communication program. (1) Persons who must report. Section Requirements as specified in § 721.72 (a), 721.5 applies to this section except for (d), (e) (concentration set at 0.1 per- § 721.5(a)(2). A person who intends to cent), (f), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), manufacture, import, or process for (g)(2)(i), and (g)(2)(v). The provision of commercial purposes a substance iden- § 721.72(d) requiring that employees be tified in paragraph (a)(1) of this section

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and intends to distribute the substance porting under this section for the sig- in commerce must submit a significant nificant new uses described in para- new use notice. graph (a)(2) of this section. (2) [Reserved] (2) The significant new uses are: (i) Protection in the workplace. Re- [54 FR 12447, Mar. 27, 1989; 54 FR 17707, Apr. 25, 1989. Redesignated at 58 FR 29946, May 24, quirements as specified in § 721.63 (a)(1), 1993, as amended at 58 FR 34204, June 23, 1993] (a)(2)(i), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(v), (b) (concentration set at 0.1 § 721.1050 Benzenamine, 2,5-dibutoxy- percent), and (c). As an alternative to 4-(4-morpholinyl)-, sulfate. the respiratory requirements listed (a) Chemical substances and significant here, a manufacturer, importer, or new uses subject to reporting. (1) The processor may choose to follow the new chemical substance identified as chemical exposure limit (NCEL) provi- benzenamine, 2,5-dibutoxy-4-(4- sions listed in the TSCA section 5(e) morpholinyl), sulfate (PMN P-90–1809; consent order for this substance. This CAS number 130169–66–3) is subject to NCEL is set at 0.4 mg/m3. reporting under this section for the sig- (ii) Hazard communication program. nificant new uses described in para- Requirements as specified in § 721.72 (a), graph (a)(2) of this section. (b), (c), (d), (e) (concentration set at 0.1 (2) The significant new uses are: percent), (f), (g)(1)(i), (g)(1)(iii), (i) Hazard communication program. Re- (g)(1)(iv), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), quirements as specified in § 721.72 (a), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(i) and (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5). (g)(5). (iii) Industrial, commercial, and con- (ii) Industrial, commercial, and consumer activities. Requirements as speci- sumer activities. Requirements as specified in § 721.80 (g) and (q). fied in § 721.80(q). (iv) Release to water. Requirements as (iii) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and specified in § 721.90(a)(1), unless the sub- (c)(1). stance is released to the Passaic Valley (b) Specific requirements. The provi- Sewerage Commission publicly-owned sions of subpart A of this part apply to treatment works (NPDES Number this section except as modified by this NJ0021016) which discharges to the New paragraph. York Bay. (1) Recordkeeping. The following rec- (b) Specific requirements. The provi- ordkeeping requirements are applicable sions of subpart A of this part apply to to manufacturers, importers, and proc- this section except as modified by this essors of this substance, as specified in paragraph. § 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (1) Recordkeeping requirements. Re- (i) and (k). quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), (f) through (i), and (k) are ap- notification requirements. The provisions plicable to manufacturers, importers, of § 721.185 apply to this section. and processors of this substance. (3) Determining whether a specific use is (2) Limitations or revocation of certain subject to this section. The provisions of notification requirements. The provisions § 721.1725(b)(1) apply to this section. of § 721.185 apply to this section. [65 FR 367, Jan. 5, 2000] (3) Determining whether a specific use is subject to this section. The provisions of § 721.1068 Benzenamine, 4-isocyanato- § 721.1725(b)(1) apply to this section. N,N-bis(4-isocyanatophenyl)-2,5- dimethoxy-. [57 FR 44061, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 58 FR 34204, June 23, (a) Chemical substance and significant 1993] new uses subject to reporting. (1) The chemical substance identified as § 721.1055 Benzeneamine, 3,5-difluoro-. benzenamine, 4-isocyanato-N,N- bis(4- (a) Chemical substance and significant isocyanatophenyl)-2,5-dimethoxy- new uses subject to reporting. (1) The (PMN P-92–168) is subject to reporting chemical substance identified as under this section for the significant benzeneamine, 3,5-difluoro- (PMN P-97– new uses described in paragraph (a)(2) 648; CAS No. 372–39–4) is subject to re- of this section.

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(2) The significant new uses are: § 721.1075 Benzenamine, 4-(1-methyl- (i) Protection in the workplace. Re- butoxy)-, hydrochloride. quirements as specified in § 721.63 (a)(1), (a) Chemical substance and significant (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), new uses subject to reporting. (1) The (a)(5)(vi), (a)(5)(vii), (a)(6)(ii), (b) (con- chemical substance identified as centration set at 1.0 percent), and (c). benzenamine, 4-(1-methylbutoxy)-, hy- (ii) Hazard communication program. drochloride (PMN P-90–559) is subject Requirements as specified in § 721.72 (a), to reporting under this section for the (b), (c), (d), (e) (concentration set at 1.0 significant new uses described in para- percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), graph (a)(2) of this section. (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (2) The significant new uses are: and (g)(5). (i) Protection in the workplace. Re- (iii) Industrial, commercial, and con- quirements as specified in § 721.63 (a)(1), sumer activities. Requirements as speci- (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), fied in § 721.80(p) (22,000 kg). (a)(5)(iii), (a)(6)(i), (b) (concentration (b) Specific requirements. The provi- set at 0.1 percent), and (c). sions of subpart A of this part apply to (ii) Hazard communication program. this section except as modified by this Requirements as specified in § 721.72 (a), paragraph. (b), (c), (d), (e) (concentration set at 0.1 (1) Recordkeeping. Recordkeeping re- percent), (f), (g)(1)(i), (g)(1)(vii), quirements as specified in § 721.125 (a) (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), through (i) are applicable to manufac- (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and (g)(5). turers, importers, and processors of (iii) Industrial, commercial, and con- this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(l). notification requirements. The provisions (iv) Release to water. Requirements as of § 721.185 apply to this section. specified in § 721.90 (a)(1), (b)(1), and (c)(1). [58 FR 51682, Oct. 4, 1993] (b) Specific requirements. The provi- § 721.1070 Benzenamine, 4-methoxy-2- sions of subpart A of this part apply to methyl-N-(3-methylphenyl). this section except as modified by this paragraph. (a) Chemical substance and significant (1) Recordkeeping requirements. Re- new uses subject to reporting. (1) The quirements as specified in § 721.125 (a) chemical substance identified generi- through (i), and (k) are applicable to cally as benzenamine, 4-methoxy-2- manufacturers, importers, and proc- methyl-N-(3-methylphenyl) (PMN P-01– essors of this substance. 152; CAS No. 93072–06–1) is subject to re- (2) Modifications or revocation of cer- porting under this section for the sig- tain notification requirements. The provi- nificant new use described in paragraph sions of § 721.185 apply to this section. (a)(2) of this section. (2) The significant new uses are: [57 FR 44062, Sept. 23, 1992, as amended at 58 (i) Release to water. Requirements as FR 34204, June 23, 1993] specified in § 721.90(a)(4), (b)(4), and § 721.1085 Benzenamine,4,4′- (c)(4) (N=5). methylenebis[N-ethyl-N-methyl-. (ii) [Reserved] (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified as a this section except as modified by this Benzenamine,4,4′-methylenebis[N- paragraph. ethyl-N-methyl- (PMN P-99–0557; CAS (1) Recordkeeping. Recordkeeping re- No. 76176–94–8) is subject to reporting quirements as specified in § 721.125(a), under this section for the significant (b), (c), and (k) are applicable to manu- new use described in paragraph (a)(2) of facturers, importers, and processors of this section. this chemical substance. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Industrial, commercial, and con- notification requirements. The provisions sumer activities. Requirements as speci- of § 721.185 apply to this section. fied in § 721.80(g). [68 FR 70174, Dec. 17, 2003] (ii) [Reserved]

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(b) Specific requirements. The provi- (i) Hazard communication. Require- sions of subpart A of this part apply to ments as specified in § 721.72 (a), (b)(2), this section except as modified by this (c), (d), (e) (concentration set at 1.0 paragraph. percent), (f), (g)(1)(iv), (g)(2)(i), (1) Recordkeeping. Recordkeeping re- (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5). quirements as specified in § 721.125 (a), (ii) Industrial, commercial, and con- (b), (c), and (i) are applicable to manu- sumer activities. Requirements as speci- facturers, importers, and processors of fied in § 721.80(l). this substance. (iii) Disposal. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.85 (a)(1), (b)(1), (c)(1), (a)(2), notification requirements. The provisions (b)(2), and (c)(2). of § 721.185 apply to this section. (iv) Release to water. Requirements as [65 FR 81399, Dec. 26, 2000] specified in § 721.90 (a)(2)(vi), (b)(2)(vi), and (c)(2)(vi). § 721.1105 Benzenamine, 4,4′- (b) Specific requirements. The provi- methylenebis[2-methyl-6-(1- sions of subpart A of this part apply to methylethyl)]-. this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping requirements. Rec- chemical substance identified as ordkeeping requirements as specified benzenamine, 4,4′-methylenebis[2-meth- in § 721.125 (a), (b), (c), (f), (g), (h), (i), yl-6-(1-methylethyl)]- (PMN P-96–93; (j), and (k) are applicable to manufac- CAS No. 16298–38–7) is subject to report- turers, importers, and processors of ing under this section for the signifi- these substances . cant new uses described in paragraph (2) Limitations or revocation of certain (a)(2) of this section. notification requirements. The provisions (2) The significant new uses are: of § 721.185 apply to this significant new (i) Release to water. Requirements as use rule. specified in § 721.90 (a)(1), (b)(1), and (3) Determining whether a specific use is (c)(1). subject to this section. The provisions of (ii) [Reserved] § 721.1725(b)(1) apply to this section. (b) Specific requirements. The provi- [57 FR 31330, July 15, 1992, as amended at 58 sions of subpart A of this part apply to FR 29946, May 24, 1993; 58 FR 34204, June 23, this section except as modified by this 1993] paragraph. (1) Recordkeeping. Recordkeeping re- § 721.1150 Substituted polyglycidyl quirements as specified in § 721.125 (a), benzenamine. (b), (c), and (k) are applicable to manu- (a) Chemical substance and significant facturers, importers, and processors of new uses subject to reporting. (1) The fol- this substance. lowing chemical substance, referred to (2) Limitations or revocation of certain by premanufacture notice number and notification requirements. The provisions its generic chemical name, is subject of § 721.185 apply to this section. to reporting under this section for the [63 FR 3422, Jan. 22, 1998] significant new uses described in paragraph (a)(2) of this section: Substituted § 721.1120 Benzenamine, 4,4′-[1,4- polyglycidyl benzeneamine, P-83–394. phenylenebis(1-methylethyli- (2) The significant new uses are: dene)]bis[2,6-dimethyl-. (i) Use in spray applications. (a) Chemical substances and signifi- (ii) Manufacture or processing with- cant new uses subject to reporting. (1) out establishing a program whereby: The chemical substance benzenamine, (A) During all stages of manufacture 4,4′-[1,4-phenylenebis(1- and processing of the substance, and methylethylidene)]bis- (CAS Registry during response to emergencies and Number 2716–10–1; PMN P-86–503) is sub- spills involving the substance, any per- ject to reporting under this section for son employed by or under the control the significant new uses described in of the manufacturer or processor who paragraph (a)(2) of this section. may potentially be dermally exposed (2) The significant new uses are: to the substance wears:

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(1) Gloves which cover the arm up to —In case of eye contact, immediately flush the elbow and which have been deter- with plenty of water and get immediate med- mined to be impervious to the sub- ical attention. —In case of skin contact, immediately wash stance under conditions of exposure with soap and water and get immediate med- (gloves may be determined to be imper- ical attention. vious by standard testing methods or by reliance on the manufacturer’s spec- (b) Specific requirements. The provi- ifications for those gloves selected); sions of subpart A of this part apply to (2) A face shield of at least 8 inches in this section except as modified by this length; and paragraph. (1) Recordkeeping. In addition to the (3) Clothing which covers any other requirements of § 721.17, manufacturers, exposed areas of the arms, legs, and importers, and processors of the chem- torso. ical substance identified in paragraph (B) All workers described in para- (a)(1) of this section must maintain the graph (a)(ii)(A) of this section are in- following records for five years from formed in writing, or by presenting the their creation: information as part of a training pro- (i) The names of persons informed, gram in a safety meeting where attend- the date they are informed, and the ance is recorded, of the following: To means by which they are informed in avoid all contact with this substance; accordance with paragraph (a)(2)(ii)(B) that structurally similar chemicals of this section. have been found to cause cancer, repro- (ii) The names of any transferee and ductive effects, kidney and liver effects the dates of any transfers of containers in laboratory animals, and allergic re- which are labeled in accordance with actions in humans; that this substance paragraph (a)(2)(ii)(C) of this section. is a severe skin and eye irritant; and (iii) The method used to determine that the use of impervious gloves, face that the protective gloves are imper- shields and other clothing to cover ex- vious to the substance and date and the posed areas of the arms, the legs, and results of that determination. the torso is required. (2) [Reserved] (C) A label is affixed to each con- [49 FR 43653, Oct. 31, 1984. Redesignated at 53 tainer of the substance or of a formula- FR 2845, Feb. 2, 1988. Further redesignated at tion containing the substance which 58 FR 29946, May 24, 1993, as amended at 58 (in a print size no smaller than ten FR 34204, June 23, 1993] point type) contains, at a minimum, the following information: § 721.1155 1,4-benzenediol, 2-(1,1,3,3- tetramethylbutyl)- and WARNING: CONTACT WITH SKIN AND Bis(dimethylamino sub- EYES IS HARMFUL stituted)carbomonocycle. —Severe skin and eye irritant. (a) Chemical substance and significant —Similar chemicals cause cancer, reproduc- new uses subject to reporting. (1) The tive effects, and kidney and liver changes in chemical substance identified generi- laboratory animals. They have also caused cally as 1,4-benzenediol, 2-(1,1,3,3- allergic reactions in humans. tetramethylbutyl)- and Bis —Prevent all contact with skin, eyes, and clothing. (dimethylamino sub- —Wear impervious gloves, face shield, and stituted)carbomonocycle (PMN P-96–92) protective clothing. Promptly remove and is subject to reporting under this sec- wash contaminated non-impervious clothing tion for the significant new uses de- before re-use. scribed in paragraph (a)(2) of this sec- —Wash thoroughly after handling and before tion. eating, drinking, or smoking. (2) The significant new uses are: STORAGE INSTRUCTIONS: (i) Release to water. Requirements as —Keep closure tight and upright to prevent specified in § 721.90 (a)(4), (b)(4), and leakage. (c)(4) (N = 1). —Keep container closed during shipment and (ii) [Reserved] when not in use. (b) Specific requirements. The provi- —In case of spillage absorb with sand or sions of subpart A of this part apply to vermiculite and flush with plenty of water. this section except as modified by this FIRST AID: paragraph.

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(1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), and (k) are applicable to manu- this section except as modified by this facturers, importers, and processors of paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements specified in § 721.125 (a), (b), notification requirements. The provisions (c), (i), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of [63 FR 3422, Jan. 22, 1998] this substance. (2) Limitations or revocation of certain § 721.1187 Bis(imidoethylene) benzene. notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The [60 FR 45081, Aug. 30, 1995] chemical substance bis(imidoethylene)benzene (PMN P-93– § 721.1210 Benzene, (2-chloroethoxy)-. 1447) is subject to reporting under this (a) Chemical substance and significant section for the significant new uses de- new uses subject to reporting. (1) The scribed in paragraph (a)(2) of this sec- chemical substance identified as ben- tion. zene, (2-chloroethoxy)- (PMN P-87–1471) (2) The significant new uses are: is subject to reporting under this sec- (i) Industrial, commercial, and con- tion for the significant new uses de- sumer activities. Requirements as speci- scribed in paragraph (a)(2) of this sec- fied in § 721.80(f). tion. (ii) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (2) The significant new uses are: (c)(1). (i) Protection in the workplace. Re- (b) Specific requirements. The provi- quirements as specified in § 721.63 sions of subpart A of this part apply to (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3) (ap- this section except as modified by this plies to gloves only), (a)(4), (a)(5)(iii), paragraph. (a)(6)(v), (b) (concentration set at 0.1 (1) Recordkeeping requirements. Rec- percent), and (c). ordkeeping requirements specified in (ii) Hazard communication program. § 721.125 (a), (b), (c), (i), and (k) are ap- Requirements as specified in § 721.72 (a), plicable to manufacturers, importers, (b)(2), (c), (d), (e) (concentration set at and processors of this substance. 0.1 percent), (f), (g)(1)(vii), (g)(2)(ii), (2) Limitations or revocation of certain (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), notification requirements. The provisions (g)(4)(i), and (g)(5). of § 721.185 apply to this section. (iii) Industrial, commercial, and consumer activities. Requirements as speci- [60 FR 11041, Mar. 1, 1995] fied in § 721.80(j). § 721.1193 Benzene, 2-bromo-1,4- (iv) Disposal. Requirements as speci- dimethoxy-. fied in § 721.85 (a)(1), (b)(1) and (c)(1). (a) Chemical substance and significant Disposal other than as described in the new uses subject to reporting. (1) The premanufacture notice referenced in chemical substance identified as ben- paragraph (a)(1) of this section. zene, 2-bromo-1,4-dimethoxy- (PMN P- (b) Specific requirements. The provi- 95–17, CAS No. 25245–34–5) is subject to sions of subpart A of this part apply to reporting under this section for the sig- this section except as modified by this nificant new uses described in para- paragraph. graph (a)(2) of this section. (1) Recordkeeping requirements. Re- (2) The significant new uses are: quirements as specified in § 721.125 (a) (i) Release to water. Requirements as through (k) are applicable to manufac- specified in § 721.90 (a)(1), (b)(1), and turers, importers, and processors of (c)(1). this substance. (ii) Industrial, commercial, and con- (2) Limitations or revocation of certain sumer activities. Requirements as speci- notification requirements. The provisions fied in § 721.80(g). of § 721.185 apply to this section.

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(3) Determining whether a specific use is sludge or equivalent) plus clarification, subject to this section. The provisions of then the amount of substance reason- § 721.1725(b)(1) apply to this section. ably likely to be removed from the [57 FR 44062, Sept. 23, 1992, as amended at 58 waste stream by such treatment may FR 29946, May 24, 1993; 58 FR 34204, June 23, be subtracted in calculating the num- 1993] ber of kilograms released. No more than 50 percent removal efficiency may § 721.1225 Benzene, 1,2-dimethyl-, poly- attributed to such treatment. propene derivatives, sulfonated, potassium salts. (b) Specific requirements. The provisions of subpart A of this part apply to (a) Chemical substances and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified as benzene, 1,2-dimethyl-, polypropene de- (1) Recordkeeping requirements. The rivatives, sulfonated, potassium salts following recordkeeping requirements (PMN P-89–711) is subject to reporting are applicable to manufacturers, im- under this section for the significant porters, and processors of this sub- new uses described in paragraph (a)(2) stance: § 721.125 (a), (b), (c), (f), (g), (h), of this section. (i), and (k). (2) The significant new uses are: (2) Limitations or revocation of certain (i) Hazard communication program. Re- notification requirements. The provisions quirements as specified in § 721.72 (a), of § 721.185 apply to this significant new (b), (c), (d), (e) (concentration set at 1.0 use rule. percent, and (f). The following environ- (3) Determining whether a specific use is mental hazard statement shall appear subject to this section. The provisions of on each label as specified in § 721.72(b) § 721.1725(b)(1) apply to this section. of this section and the MSDS as specified in § 721.72(c) of this section: EPA is [56 FR 15789, Apr. 17, 1991. Redesignated and requiring aquatic toxicity testing and amended at 58 FR 29946, May 24, 1993; 58 FR fate testing for a substance in this 34204, June 23, 1993] product. These requirements are based § 721.1230 Benzene, ethenyl-, ar-bromo on EPA’s determination that the sub- derivatives. stance causes toxicity to fish and aquatic organisms based on data on the (a) Chemical substance and significant substance and similar sulfonate com- new uses subject to reporting. (1) The pounds. EPA has further determined chemical substance identified as ben- that discharge of this substance may zene, ethenyl-, ar-bromo derivatives cause toxicity to fish and aquatic orga- (PMN P-84–660; CAS No. 125904–11–2) is nisms at concentrations as low as 25 subject to reporting under this section ppb. Water releases of the substance for the significant new uses described are subject to an EPA Significant New in paragraph (a)(2) of this section. The Use Rule (SNUR) under 40 CFR part 721 requirements of this SNUR do not which requires that EPA be notified 90 apply when the substance is present days prior to use resulting in surface only in a mixture or in a polymer ma- water concentrations in excess of this trix, if the combined concentration of level. this substance and the substance iden- (ii) Industrial, commercial, and con- tified in § 721.1240 as benzene, (2- sumer activities. Requirements as speci- bromoethyl)-, ar-bromo derivatives fied in § 721.80 (l) and (q). (PMN P-84–704; CAS No. 125904–10–1), (iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and present as residual monomers in the (c)(4) (where N = 25 ppb). The require- mixture or polymer matrix, does not ment of 40 CFR 721.91(a)(4) that the exceed 0.5% by weight or volume. This amount of the substance estimated to exemption does not apply if there is be released to water is calculated be- reason to believe that during intended fore entering control technology is not use, processing, or other handling, retained. If the waste stream con- these substances combined may be retaining the substance will be treated concentrated above the 0.5% level in using biological treatment (activated the mixture or polymer matrix.

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(2) The significant new uses are: (i) with Subtitle C of the Resource Con- Protection in the workplace. Require- servation and Recovery Act. ments as specified in § 721.63 (a)(1) (in- (B) Any forms of the substance other cluding when the substance becomes than those described in paragraph airborne in any form), (a)(3), (a)(4) (a)(2)(iv)(A) of this section, including (when the substance becomes airborne waste streams containing 1.0% or less in any form), (a)(5)(iii), (a)(5)(xii), of this substance and the substance (a)(5)(xiii), (a)(5)(xiv), (a)(5)(xv) and (c). identified in § 721.1240, shall be disposed As an alternative to the respiratory re- of as follows: § 721.85 (a)(1), (b)(1), (c)(1), quirements listed here, a manufac- (a)(2), (b)(2), (c)(2), (a)(3), (b)(3), (c)(3), turer, importer, or processor may carbon adsorption followed by either choose to follow the NCEL provisions physical destruction, or as specified in in the TSCA section 5(e) consent order § 721.90; the landfill shall be operated in for this substance. accordance with the Resource Con- (ii) Hazard communication program. servation and Recovery Act. Requirements as specified in § 721.72 (a), (v) Release to water. Requirements as (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), specified in § 721.90 (a)(2)(iv), (b)(2)(iv), (g)(1)(vi) (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (c)(2)(iv), (a)(2)(v), (b)(2)(v), (c)(2)(v), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(4)(i), (a)(3), (b)(3), and (c)(3). and (g)(5). (b) Specific requirements. The provi- (iii) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Requirements as speci- this section except as modified by this fied in § 721.80 (a), (b), (j) (flame retard- paragraph. ant), and (l). (1) Recordkeeping. The following rec- (iv) Disposal. It is a significant new ordkeeping requirements are applicable use to dispose of the substance other to manufacturers, importers, and proc- than as follows: essors of this substance, as specified in (A) The following forms of the sub- § 721.125 (a) through (k). stance - the substance as a commercial (2) Limitations or revocation of certain chemical product or manufacturing notification requirements. The provisions chemical intermediate; the substance of § 721.185 apply to this section. as an off-specification commercial chemical product or manufacturing [67 FR 17647, Apr. 11, 2002] chemical intermediate; the substance as a residue remaining in a container § 721.1240 Benzene, (2-bromoethyl)-, or in an inner liner removed from a ar-bromo derivatives. container that has held the substance, (a) Chemical substance and significant unless the container is empty as de- new uses subject to reporting. (1) The fined in 40 CFR 261.7(b)(3); any residue chemical substance identified as ben- or contaminated soil, water, or other zene, (2-bromoethyl)-, ar-bromo deriva- debris resulting from the cleanup of a tives (PMN P-84–704; CAS No. 125904–10– spill into or on any land or water of the 1) is subject to reporting under this substance as a commercial chemical section for the significant new uses de- product or manufacturing chemical inscribed in paragraph (a)(2) of this sec- termediate, or any residue or contami- tion. The requirements of this SNUR nated soil, water, or other debris re- do not apply when the substance is sulting from the cleanup of a spill into present only in a mixture or in a poly- or on any land or water, of the sub- mer matrix, if the combined concentra- stance as an off-specification commer- tion of this substance and the sub- cial chemical product or manufac- stance identified in § 721.1230 as ben- turing chemical intermediate; and any zene, ethenyl-, ar-bromo derivatives waste stream containing greater than (PMN P-84–660; CAS No.125904–11–2) 1.0% of this substance and the sub- present as residual monomers in the stance identified in § 721.1240 combined mixture or polymer matrix, does not - shall be disposed of as follows: Re- exceed 0.5% by weight or volume. This quirements as specified in § 721.85 (a)(1), exemption does not apply if there is (b)(1), (c)(1), (a)(2), (b)(2), and (c)(2); the reason to believe that during intended landfill shall be operated in accordance use, processing, or other handling,

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these substances combined may be requirements as specified in § 721.85 (a)(1), concentrated above the 0.5% level in (b)(1), (c)(1), (a)(2), (b)(2), and (c)(2); the the mixture or polymer matrix. landfill shall be operated in accordance (2) The significant new uses are: (i) with Subtitle C of the Resource Con- Protection in the workplace. Require- servation and Recovery Act. ments as specified in § 721.63 (a)(1) (in- (B) Any forms of the substance other cluding when the substance becomes than those described in paragraph airborne in any form), (a)(3), (a)(4) (a)(2)(iv)(A) of this section, including (when the substance becomes airborne waste streams containing 1.0% or less in any form), (a)(5)(iii), (a)(5)(xii), of this substance and the substance (a)(5)(xiii), (a)(5)(xiv), (a)(5)(xv), and identified in § 721.1240, shall be disposed (c). As an alternative to the res- of as follows: § 721.85 (a)(1), (b)(1), (c)(1), piratory requirements listed here, a (a)(2), (b)(2), (c)(2), (a)(3), (b)(3), (c)(3), manufacturer, importer, or processor carbon adsorption followed by either may choose to follow the NCEL provi- physical destruction, or as specified in sions in the TSCA section 5(e) consent § 721.90; the landfill shall be operated in order for this substance. accordance with the Resource Con- (ii) Hazard communication program. servation and Recovery Act. Requirements as specified in § 721.72 (a), (v) Release to water. Requirements as (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), specified in § 721.90 (a)(2)(iv), (b)(2)(iv), (g)(1)(vi) (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (c)(2)(iv), (a)(2)(v), (b)(2)(v), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(4)(i), (c)(2)(v),(a)(3), (b)(3), and (c)(3). and (g)(5). (b) Specific requirements. The provi- (iii) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Requirements as speci- this section except as modified by this fied in § 721.80 (a), (b), (c), (h) (in the paragraph. manufacture of the substance identi- (1) Recordkeeping. The following rec- fied in § 721.1230), and (l). ordkeeping requirements are applicable (iv) Disposal. It is a significant new to manufacturers, importers, and proc- use to dispose of the substance other essors of this substance, as specified in than as follows: § 721.125 (a) through (k). (A) The following forms of the sub- (2) Limitations or revocation of certain stance - the substance as a commercial notification requirements. The provisions chemical product or manufacturing of § 721.185 apply to this section. chemical intermediate; the substance as an off-specification commercial [67 FR 17648, Apr. 11, 2002] chemical product or manufacturing chemical intermediate; the substance § 721.1300 [(Dinitrophenyl)azo]-[2,4- diamino-5-methoxybenzene] deriva- as a residue remaining in a container tives. or in an inner liner removed from a container that has held the substance, (a) Chemical substances and significant unless the container is empty as de- new uses subject to reporting. (1) The fined in 40 CFR 261.7(b)(3); any residue chemical substances identified generi- or contaminated soil, water, or other cally as [(dinitrophenyl)azo]-[2,4-dia- debris resulting from the cleanup of a mino-5-methoxybenzene] derivatives spill into or on any land or water of the (P-83–817 and P-83–818) are subject to substance as a commercial chemical reporting under this section for the sig- product or manufacturing chemical in- nificant new uses described in para- termediate, or any residue or contami- graph (a)(2) of this section. nated soil, water, or other debris re- (2) The significant new uses are: sulting from the cleanup of a spill into (i) Industrial, commercial, and con- or on any land or water, of the sub- sumer activities. Requirements as speci- stance as an off-specification commer- fied in § 721.80 (v)(1), (v)(2), (w)(1), cial chemical product or manufac- (w)(2), (x)(1), and (x)(2). turing chemical intermediate; and any (ii) [Reserved] waste stream containing greater than (b) Specific requirements. The provi- 1.0% of this substance and the sub- sions of subpart A of this part apply to stance identified in § 721.1230 combined this section except as modified by this - shall be disposed of as follows: Re- paragraph.

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(1) Recordkeeping. The following rec- new uses described in paragraph (a)(2) ordkeeping requirements are applicable of this section. to manufacturers, importers, and proc- (2) The significant new uses are: essors of this substance: § 721.125 (a), (i) Protection in the workplace. Re- (b), (c), and (i). quirements as specified in § 721.63 (a)(1), (2) Limitations or revocation of certain (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), (b) notification requirements. The provisions (concentration set at 1.0 percent), and of § 721.185 apply to this section. (c). However, the personal protective [56 FR 25990, June 5, 1991. Redesignated at 58 clothing required in paragraph FR 29946, May 24, 1993, as amended at 58 FR (a)(2)(iv) must be tested or evaluated 34204, June 23, 1993] under the requirements of paragraph § 721.1325 Benzene, 1-(1-methylbu- (a)(3). Furthermore, the impervious- toxy)-4-nitro-. ness of gloves required under paragraph (a)(2)(i) may not be demonstrated ac- (a) Chemical substance and significant cording to paragraph (a)(3)(ii), but new uses subject to reporting. (1) The chemical substance identified as ben- rather must be tested according to zene, 1-(1-methylbutoxy)-4-nitro- (PMN paragraph (a)(3)(i) with the following P-90–560) is subject to reporting under additional requirements: There must this section for the significant new be no permeation of the PMN sub- uses described in paragraph (a)(2) of stance greater than 16 ppb after 8 hours this section. of testing in accordance with the (2) The significant new uses are: American Society for Testing and Ma- (i) Protection in the workplace. Re- terials (ASTM) F739–85 ‘‘Standard Test quirements as specified in § 721.63 (a)(1), Method for Resistance of Protective (a)(3), (a)(6)(i), (b) (concentration set at Clothing Materials to Permeation by 1.0 percent), and (c). Liquids or Gases.’’ Gloves may not be (ii) Hazard communication program. used for a time period longer than they Requirements as specified in § 721.72 (a), are actually tested and must be re- (b), (c), (d), (e) (concentration set at 0.1 placed at the end of each work shift. percent), (f), (g)(1)(vi), (g)(1)(ix), (ii) Hazard communication program. (g)(2)(i), (g)(2)(v), and (g)(5). Requirements as specified in § 721.72 (a), (iii) Industrial, commercial, and con- (b), (c), (d), (e) (concentration set at 1.0 sumer activities. Requirements as speci- percent), (f), (g)(1)(iv), (g)(2)(i), fied in § 721.80 (l) and (p) (production (g)(2)(iii), (g)(2)(v), (g)(3)(ii), (g)(4)(i) limit set at 43,000 kg). and (g)(5). (b) Specific requirements. The provi- (iii) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Requirements as speci- this section except as modified by this fied in § 721.80(q). In addition, a signifi- paragraph. (1) Recordkeeping requirements. Re- cant use of the substance is any man- quirements as specified in § 721.125 (a) ner or method of manufacturing, proc- through (i) are applicable to manufac- essing, or use other than as an insu- turers, importers, and processors of lating oil for capacitors or trans- this substance. formers. (2) Modifications or revocation of cer- (iv) Disposal. Requirements as speci- tain notification requirements. The provi- fied in § 721.85 (a)(1), (b)(1), (c)(1), (a)(2), sions of § 721.185 apply to this section. (b)(2), (c)(2), (a)(3), (b)(3), and (c)(3). (b) Specific requirements. The provi- [57 FR 44062, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993] sions of subpart A of this part apply to this section. § 721.1350 Benzene, (1-methylethyl)(2- (1) Recordkeeping. The following rec- phenylethyl)-. ordkeeping requirements are applicable (a) Chemical substances and significant to manufacturers, importers, and proc- new uses subject to reporting. (1) The essors of this substance, as specified in chemical substance identified as ben- § 721.125 (a) through (j). zene, (1-methylethyl)(2-phenylethyl)-, (2) Limitations or revocation of certain (PMN P-88–894) is subject to reporting notification requirements. The provisions under this section for the significant of § 721.185 apply to this section.

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(3) Determining whether a specific use is are not required under § 721.72 (a) and subject to this section. The provisions of (c), respectively. The provision of § 721.1725(b)(1) apply to this section. § 721.72(g) requiring placement of spe- [56 FR 40210, Aug. 13, 1991. Redesignated and cific information on an MSDS does not amended at 58 FR 29946, May 24, 1993; 58 FR apply when a MSDS in not required 34204, June 23, 1993] under § 721.72(c). (iii) Industrial, commercial, and con- § 721.1372 Substituted nitrobenzene. sumer activities. Requirements as speci- (a) Chemical substance and significant fied in § 721.80(g). new uses subject to reporting. (1) The (iv) Disposal. Requirements as speci- chemical substance identified as a sub- fied in § 721.85 (a)(1), (b)(1), and (c)(1). stituted nitrobenzene (PMN P-92–1125) (b) Specific requirements. The provi- is subject to reporting under this sec- sions of subpart A of this part apply to tion for the significant new uses de- this section except as modified by this scribed in paragraph (a)(2) of this sec- paragraph. tion. (2) The significant new uses are: (1) Recordkeeping. The following rec- (i) Release to water. Requirements as ordkeeping requirements are applicable specified in § 721.90 (a)(4), (b)(4), and to manufacturers, importers, and proc- (c)(4) (where N = 50 ppb). essors of this substance, as specified in (ii) [Reserved] § 721.125 (a) through (c), (e), (f) and (i). (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this significant new paragraph. use rule. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), [55 FR 32416, Aug. 9, 1990. Redesignated at 58 (b), (c), and (k) are applicable to manu- FR 29947, May 24, 1993, as amended at 58 FR 34204, June 23, 1993] facturers, importers, and processors of this substance. § 721.1425 Pentabromoethylbenzene. (2) Limitations or revocation of certain notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new use subject to reporting. (1) The chemical substance [58 FR 51682, Oct. 4, 1993] pentabromoethylbenzene (CAS Number § 721.1375 Disubstituted nitrobenzene 85–22–3) is subject to reporting under (generic name). this section for the significant new use (a) Chemical substance and significant described in paragraph (a)(2) of this new uses subject to reporting. (1) The section. chemical substance disubstituted (2) The significant new use is: Any nitrobenzene (PMN P-84–860) is subject use. to reporting under this section for the (b) Specific requirements. The provi- significant new uses described in para- sions of subpart A of this part apply to graph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph: (i) Protection in the workplace. Re- (1) Persons who must report. Section quirements as specified in § 721.63 (a)(1), 721.5 applies to this section except for (a)(3), (b) (concentration set at 0.1 per- § 721.5(a)(2). A person who intends to cent), and (c). manufacture, import, or process for (ii) Hazard communication program. commercial purposes the substance Requirements as specified in § 721.72 identified in paragraph (a)(1) of this (b)(2), (d), (e) (concentration set at 0.1 section and intends to distribute the percent), (f) and (g)(1)(vii), (g)(2)(i), substance in commerce must submit a (g)(2)(v). The provisions of § 721.72(d) re- significant new use notice. quiring employees to be provided with information on the location and avail- (2) [Reserved] ability of a written hazard communica- [54 FR 18286, Apr. 28, 1989. Redesignated at 58 tion program and MSDSs do not apply FR 29947, May 24, 1993, as amended at 58 FR when the written program and MSDS 34204, June 23, 1993]

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§ 721.1430 Pentachlorobenzene. (2) The significant new use is: Manu- facture, import, or processing of 10,000 (a) Chemical substance and significant pounds or more per year per facility for new use subject to reporting. (1) The any use. chemical substance (b) Specific requirements. The provi- pentachlorobenzene (CAS No. 608–93–5) sions of subpart A of this part apply to is subject to reporting under this sec- this section except as modified by this tion for the significant new use de- paragraph. scribed in paragraph (a)(2) of this sec- (1) Recordkeeping. The following rec- tion. ordkeeping requirements are applicable (2) The significant new use is: Manu- to manufacturers, importers, and proc- facture, import, or processing of 10,000 essors of this substance, as specified in pounds or more per year per facility for § 721.125 (a), (b), and (c). any use. (2) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to [58 FR 63516, Dec. 1, 1993] this section except as modified by this § 721.1450 1,3-Benzenediamine, 4-(1,1- paragraph. dimethylethyl)-ar-methyl. (1) Recordkeeping. The following recordkeeping requirements are applicable (a) Chemical substance and significant to manufacturers, importers, and proc- new uses subject to reporting. (1) The fol- essors of this substance, as specified in lowing chemical substance, referred to § 721.125 (a), (b), and (c). by its PMN number and chemical name, is subject to reporting under (2) [Reserved] this section for the significant new [58 FR 63516, Dec. 1, 1993] uses described in paragraph (a)(2) of this section: P-85–929; 1,3- § 721.1435 1,2,4,5-Tetrachlorobenzene. Benzenediamine, 4-(l,1-dimethylethyl)- (a) Chemical substance and significant ar-methyl. new use subject to reporting. (1) The (2) The significant new uses are: chemical substance 1,2,4,5- (i) Use other than for applications tetrachlorobenzene (CAS No. 95–94–3) is where the substance will be completely subject to reporting under this section reacted (cured or used as a chemical infor the significant new use described in termediate). paragraph (a)(2) of this section. (ii) Any method of disposal other (2) The significant new use is: Manu- than by landfill, incineration, or for facture, import, or processing of 10,000 wastewater from vent scrubbers, steam pounds or more per year per facility for vacuum ejectors, pad washings, equip- any use. ment washouts, and stormwater run- (b) Specific requirements. The provi- offs, wastewater treatment in per- sions of subpart A of this part apply to mitted industrial wastewater treat- this section except as modified by this ment facilities. Each method of dis- paragraph. posal must meet all applicable local, (1) Recordkeeping. The following rec- State, and Federal laws and regula- ordkeeping requirements are applicable tions. to manufacturers, importers, and proc- (iii) Any manner or method of manu- essors of this substance, as specified in facturing, importing, or processing § 721.125 (a), (b), and (c). without establishing a program where- (2) [Reserved] by: (A) Any person who may be exposed [58 FR 63516, Dec. 1, 1993] dermally to the substance wears: (1) Gloves which have been deter- § 721.1440 1,3,5-Trinitrobenzene. mined to be impervious to the sub- (a) Chemical substance and significant stance under the conditions of expo- new use subject to reporting. (1) The sure, including the duration of expo- chemical substance 1,3,5- sure. This determination is made ei- trinitrobenzene (CAS No. 95–35–4) is ther by testing the gloves under the subject to reporting under this section conditions of exposure or by evaluating for the significant new use described in the specifications provided by the man- paragraph (a)(2) of this section. ufacturer of the gloves. Testing or

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evaluation of specifications includes (E) Each container of the substance consideration of permeability, penetra- distributed in commerce has affixed to tion, and potential chemical and me- it a label which includes a Warning chanical degradation by the substance Statement which consists, at a min- and associated chemical substances. imum, of the language specified in (2) Clothing which covers any other paragraph (a)(2)(iii)(C)(1) of this sec- exposed areas of the arms, legs, and tion. The first word of the Warning torso. Statement is capitalized, and the type (3) Chemical safety goggles or equiv- size of the first word is no smaller than alent eye protection. 6-point type for a label 5 square inches (B) Any person who may be exposed or less in area, 10-point type for a label to the substance through inhalation above 5 but no greater than 10 square during manufacture, in addition to the inches in area, 12-point type for a label dermal protective equipment described above 10 but no greater than 15 square in paragraph (a)(2)(iii)(A) of this sec- inches in area, 14-point type for a label tion, wears at a minimum, a National above 15 but no greater than 30 square Institute for Occupational Safety and inches in area, or 18-point type for a Health approved, category 23C res- label over 30 square inches in area. The pirator, organic vapor type. Use of the type size of the remainder of the Warn- ing Statement is no smaller than 6- respirator must be according to 29 CFR point type. All required label text is of 1910.134 and 30 CFR part 11. If a full- sufficient prominence, and is placed face type respirator is selected and with such conspicuousness relative to worn, the chemical safety goggles re- other label text and graphic material, quirement in paragraph (a)(2)(iii)(A)(3) to ensure that the Warning Statement of this section is waived. is read and understood by the ordinary (C)(1) All persons who may be ex- individual under customary conditions posed to the substance are informed, in of purchase and use. writing, and by presenting the informa- (iv) Manufacturing and importing the tion as part of a training program in substance for any use at greater than safety meetings at which attendance is the aggregrate volumes allowed under recorded, by means of the following the consent order issued for statement: Premanufacture Notice P-85–929, with- WARNING: Avoid all contact. Chemicals out submitting to EPA the cor- similar in structure to [insert appropriate responding scientifically valid toxicity name] have been found to cause chronic test data required under that order, de- organ and systemic effects and cancer in lab- veloped according to EPA’s Good Lab- oratory animals. To protect yourself, you oratory Practice standards at 40 CFR must wear chemical safety goggles or equiv- part 792 and EPA’s testing guidelines alent eye protection, impervious gloves, and at 40 CFR 798.2650 and 798.3300. protective clothing while handling this material. (b) Specific requirements. The provisions of subpart A of this part apply to (2) During manufacture, the warning this section except as modified by this statement in paragraph (a)(2)(iii)(C)(1) paragraph. of this section shall include the addi- (1) Determining whether a use is a sig- tional following statement: nificant new use. (i) Any person who intends to manufacture or import the Respirators are required during clean-up or loading of bulk material. substance identified in paragraph (a)(1) of this section shall, before com- (D) All persons that receive the PMN mencing any manufacture or import, substance are notified by means of a submit to EPA the information re- Material Safety Data Sheet (‘‘MSDS’’) quired under § 721.11(b). which includes, at a minimum, the lan- (ii) EPA will review this information guage specified in paragraph to determine whether the person has a (a)(2)(iii)(C)(1) of this section, and bona fide intent to manufacture or im- specifies the requirements for protec- port the substance. If EPA determines tive equipment in paragraph that the person has a bona fide intent (a)(2)(iii)(A) and (a)(2)(iii)(B) of this to manufacture or import the subsection. stance, EPA will tell the person the

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specific production volumes which § 721.1500 1,2-Benzenediamine, 4- would constitute a significant new use ethoxy, sulfate. under paragraph (a)(2)(iv) of this sec- (a) Chemical substance and significant tion. new use subject to reporting. (1) The fol- (iii) A disclosure to a person with a lowing chemical substance referred to bona fide intent to manufacture or im- by its chemical name is subject to report the substance of the specific pro- porting under this section for the sig- duction volumes which would con- nificant new use described in paragraph stitute a significant new use under (a)(2) of this section: 1,2- paragraph (a)(2)(iv) of this section will benzenediamine, 4-ethoxy, sulfate, not be considered public disclosure of PMN P-83–105. confidential business information under section 14 of the Act. (2) The significant new use is: Manu- facture, import, or processing in pow- (2) Recordkeeping. In addition to the der or dry solid form. requirements of § 721.40, manufacturers, importers, and processors must main- (b) [Reserved] tain the following records for 5 years (Sec. 5, Pub. L. 94–469, 90 Stat. 2012 (15 U.S.C. after the date they are created: 2604)) (i) Any determination that gloves are [49 FR 43061, Oct. 26, 1984. Redesignated at 53 impervious to the substance. FR 2845, Feb. 2, 1988. Further redesignated at (ii) Names of persons who have at- 58 FR 29946, May 24, 1993, as amended at 58 tended safety meetings in accordance FR 34204, June 23, 1993] with paragraph (a)(2)(iii)(C) of this section, the dates of such meetings, and § 721.1550 Benzenediazonium, 4-(di- copies of any written information pro- methylamino)-, salt with 2-hydroxy- vided in accordance with paragraph 5-sulfobenzoic acid (1:1). (a)(2)(iii)(C) of this section. (a) Chemical substance and significant (iii) Copies of any MSDSs used. new uses subject to reporting. (1) The (iv) Names and addresses of all per- chemical substance identified as ben- sons to whom the substance is sold or zenediazonium, 4-(dimethylamino)-, transferred including shipment des- salt with 2-hydroxy-5-sulfobenzoic acid tination address if different, the date of (1:1) (CAS No. 124737–31–1) (P-90–1366) is each transfer, and the quantity of sub- subject to reporting under this section stance sold or transferred on such date. for the significant new uses described (v) Copies of any labels used. in paragraph (a)(2) of this section. (vi) Any names used for the sub- (2) The significant new uses are: stance and the corresponding dates of (i) Protection in the workplace. Re- use. quirements as specified in § 721.63 (a)(1), (vii) Quantities of the substance (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i), manufactured or imported, with the (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), corresponding dates of manufacture or (a)(5)(vi), (a)(5)(vii), (a)(6)(i), (a)(6)(ii), import. and (c). (viii) Quantities of the substance pur- (ii) Hazard communication program. chased in the United States by proc- Requirements as specified in § 721.72 (a), essors of the substance, names and ad- (b), (c), (d), (f), (g)(2)(iii), (g)(2)(iv), dresses of suppliers, and corresponding (g)(2)(v), (g)(3)(ii), and (g)(5). In addi- dates of purchase. tion, the following human health haz- (ix) Information on disposal of the ard statement shall appear on each substance, including dates waste mate- label as specified at § 721.72(b) and the rial is disposed of, location of disposal MSDS as specified at § 721.72(c). Addi- sites, volume of disposed solid mate- tional statements may be included as rial, estimated volume of any disposed long as they are true and do not alter liquid wastes containing the substance, the meaning of the required statement. and method of disposal. Human health hazard statements: This [55 FR 20795, May 21, 1990. Redesignated at 58 substance may cause severe acute tox- FR 29946, May 24, 1993, as amended at 58 FR icity and death or serious neurotoxic 34204, June 23, 1993] effects.

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(iii) Industrial, commercial, and con- § 721.1568 Substituted benzenedia- sumer activities. Requirements as speci- zonium. fied in § 721.80(p) (volume set at 31,000 (a) Chemical substance and significant kg). new uses subject to reporting. (1) The (iv) Release to water. Requirements as chemical substance identified generi- specified in § 721.90 (a)(4), (b)(4), and cally as a substituted benzenedia- (c)(4) (N = 80 ppb). zonium (PMN P-93–533) is subject to re- (b) Specific requirements. The provi- porting under this section for the sig- sions of subpart A of this part apply to nificant new uses described in para- this section. graph (a)(2) of this section. (1) Recordkeeping. The following rec- (2) The significant new uses are: ordkeeping requirements are applicable (i) Industrial, commercial, and con- to manufacturers, importers, and proc- sumer activities. Requirements as speci- essors of this substance as specified in fied in § 721.80(h). § 721.125 (a) through (i), and (k). (ii) [Reserved] (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this significant new this section except as modified by this use rule. paragraph. [56 FR 40211, Aug. 13, 1991. Redesignated at 58 (1) Recordkeeping. Recordkeeping re- FR 29946, May 24, 1993, as amended at 58 FR quirements as specified in § 721.125 (a), 34204, June 23, 1993] (b), (c), and (i) are applicable to manufacturers, importers, and processors of § 721.1555 Substituted phenyl azo sub- this substance. stituted benzenediazonium salt. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generi- [58 FR 51682, Oct. 4, 1993] cally as a substituted phenyl azo substituted benzenediazonium salt (PMN § 721.1576 1,3-Benzenedicarboxylic P-92–652) is subject to reporting under acid, bis[[4-[(ethenyloxy)methyl] this section for the significant new cyclohexyl] methyl] ester. uses described in paragraph (a)(2) of (a) Chemical substance and significant this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified as 1,3- (i) Hazard communication program. Re- benzenedicarboxylic acid, bis[[4- quirements as specified in § 721.72 (a), [(ethenyloxy)methyl] cyclohexyl] (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), and methyl] ester (PMN P-98–1162; CAS No. (g)(5). 119581–93–0) is subject to reporting (ii) Release to water. Requirements as under this section for the significant specified in § 721.90 (a)(1), (b)(1), and new uses described in paragraph (a)(2) (c)(1). of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified in § 721.90 (a)(1), (b)(1), and paragraph. (c)(1). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), (f), (g), (h), and (k) are applica- sions of subpart A of this part apply to ble to manufacturers, importers, and this section except as modified by this processors of this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (k) are applicable to manufacturers, importers, and processors of [58 FR 51682, Oct. 4, 1993] these substances.

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(2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (k) are applicable to manufacturers, importers, and processors of [65 FR 367, Jan. 5, 2000] these substances. § 721.1577 1,4-Benzenedicarboxylic (2) Limitations or revocation of certain acid, bis [4-(ethenyloxy) butyl] notification requirements. The provisions ester. of § 721.185 apply to this section. (a) Chemical substance and significant [65 FR 367, Jan. 5, 2000] new uses subject to reporting. (1) The chemical substance identified as 1,4- § 721.1579 1,2,4-Benzenetricarboxylic benzenedicarboxylic acid, bis[4- acid, tris [4-(ethenyloxy) butyl] (ethenyloxy) butyl] ester (PMN P-98– ester. 1163; CAS No. 117397–31–6) is subject to (a) Chemical substance and significant reporting under this section for the sig- new uses subject to reporting. (1) The nificant new uses described in para- chemical substance identified as 1,2,4- graph (a)(2) of this section. benzenetricarboxylic acid, tris [4- (2) The significant new uses are: (ethenyloxy) butyl] ester (PMN P-98– (i) Release to water. Requirements as 1165; CAS No. 196109–17–8) is subject to specified in § 721.90 (a)(1), (b)(1), and reporting under this section for the sig- (c)(1). nificant new uses described in para- (ii) [Reserved] graph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified in § 721.90 (a)(1), (b)(1), and paragraph. (c)(1). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), and (k) are applicable to manu- sions of subpart A of this part apply to facturers, importers, and processors of this section except as modified by this these substances. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (k) are applicable to manufacturers, importers, and processors of [65 FR 367, Jan. 5, 2000] these substances. § 721.1578 1,4-Benzenedicarboxylic (2) Limitations or revocation of certain acid, bis[[4-[(ethenyloxy)methyl] notification requirements. The provisions cyclohexyl] methyl] ester. of § 721.185 apply to this section. (a) Chemical substance and significant [65 FR 367, Jan. 5, 2000] new uses subject to reporting. (1) The chemical substance identified as 1,4- § 721.1580 Disubstituted benzene benzenedicarboxylic acid, bis[[4- ether, polymer with substituted [(ethenyloxy)methyl] cyclohexyl] phenol (generic). methyl] ester (PMN P-98–1164; CAS No. (a) Chemical substance and significant 209072–72–0) is subject to reporting new uses subject to reporting. (1) The under this section for the significant chemical substance generically identi- new uses described in paragraph (a)(2) fied as disubstituted benzene ether, of this section. polymer with substituted phenol (PMN (2) The significant new uses are: P-98–155) is subject to reporting under (i) Release to water. Requirements as this section for the significant new specified in § 721.90 (a)(1), (b)(1), and uses described in paragraph (a)(2) of (c)(1). this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(1), (b)(1), and this section except as modified by this (c)(1). paragraph. (ii) [Reserved]

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(b) Specific requirements. The provi- percent removal efficiency may be at- sions of subpart A of this part apply to tributed to such treatment. this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125 (a), paragraph. (b), (c), and (k) are applicable to manu- (1) Recordkeeping. Recordkeeping re- facturers, importers, and processors of quirements as specified in § 721.125 (a), this substance. (b), (c), (f), (g), (h), (j), and (k) are ap- (2) Limitations or revocation of certain plicable to manufacturers, importers, notification requirements. The provisions and processors of this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [63 FR 44575, Aug. 20, 1998] of § 721.185 apply to this section. § 721.1612 Substituted 2-nitro- and 2- [59 FR 27482, May 27, 1994] aminobenzesulfonamide. § 721.1620 Benzenesulfonamide, (a) Chemical substances and significant alkylphenyl substituted phenyl sub- new uses subject to reporting. (1) The stituted carbonyl- (generic). chemical substances identified generi- (a) Chemical substance and significant cally as substituted 2-nitro- and 2- new uses subject to reporting. (1) The aminobenzenesulfonamide (PMNs P-88– chemical substance identified generi- 1937 and P-88–1938) are subject to re- cally as benzenesulfonamide porting under this section for the sig- alkylphenyl substituted phenyl sub- nificant new uses described in para- stituted carbonyl- (PMN P-00–368) is graph (a)(2) of this section. subject to reporting under this section (2) The significant new uses are: for the significant new uses described (i) Hazard communication program. Re- in paragraph (a)(2) of this section. quirements as specified in § 721.72 (a) (2) The significant new uses are: through (d), (f), (g)(3)(i), (g)(3)(ii), (i) Protection in the workplace. Re- (g)(4)(i), and (g)(5). The following addi- quirements as specified in § 721.63(a)(4), tional statements shall appear on each (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), label and MSDS required by this para- (a)(5)(vii), (a)(6)(i), (b) (concentration graph: This substance may be toxic to set at 1.0%), and (c). As an alternative terrestrial organisms and plants. No- to the respiratory requirements listed tice to user: Release to water restric- here, a manufacturer, importer, or tions apply. processor may choose to follow the new (ii) Disposal. Requirements as speci- chemical exposure limit (NCEL) provi- fied in § 721.85. A significant new use of sions listed in the TSCA section 5(e) these substances is any release of the consent order for this chemical sub- substances to land. stance. (iii) Release to water. Requirements as (ii) Hazard communication program. specified in § 721.90 (a)(4), (b)(4), and Requirements as specified in § 721,72(a), (c)(4) (where N = 100 ppb for P-88–1937 (b), (c), (d), (e) (concentration set at and N = 10 ppb for P-88–1938). When cal- 1.0%), (f), (g)(1)(iv), (g)(2)(ii), (g)(2)(iv), culating the surface water concentra- (g)(3)(ii), (g)(4)(i), and (g)(5). tions according to the instructions in (iii) Release to water. Requirements as § 721.91(a)(4), the statement that the specified in § 721.90(a)(4), (b)(4), and amount of the substances that will be (c)(4) (N=30). released will be calculated before the (b) Specific requirements. The provi- substances enter control technology sions of subpart A of this part apply to does not apply. Instead, if the waste this section except as modified by this stream containing the PMN substances paragraph. will be treated before release, the (1) Recordkeeping. Recordkeeping re- amount of the PMN substances reason- quirements as specified in § 721.125(a), ably likely to be removed from the (b), (c), (d), (f), (g), (h), and (k) are ap- waste stream by treatment may be plicable to manufacturers, importers, subtracted in calculating the number and processors of this chemical sub- of kilograms released. No more than 50 stance.

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(2) Limitations or revocation of certain ethanediyloxy)]bis-, bis(4- notification requirements. The provisions methylbenzene-sulfonate) (PMN P-93– of § 721.185 apply to this section. 1195, CAS no. 19249–03–7), ethanol, 2,2′- [oxybis(2,1-ethanediyloxy)] bis-, bis(4- [68 FR 70174, Dec. 17, 2003] methylbenzene sulfonate) (PMN P-93– ′ § 721.1625 Alkylbenzene sulfonate, 1196, CAS no. 37860–51–8), ethanol, 2,2 - amine salt. [[1-[(2-propenyloxy) methyl]-1,2- ethanediyl]bis(oxy)]bis-, bis(4- (a) Chemical substance and significant methylbenzene sulfonate) (PMN P-93– new uses subject to reporting. (1) The 1203, CAS no. 114719–15–2), and ethanol, chemical substance identified generi- 2-[1-[[2-[2- [[(4-methylphenyl) sulfonyl] cally as alkylbenzene sulfonate, amine oxy]ethoxy] ethoxy]methyl]-2-(2- salt (PMN P-90–456) is subject to re- propenyloxy)ethoxy]-, 4- porting under this section for the sig- methylbenzenesulfonate (PMN P-93– nificant new use described in paragraph 1204, CAS no. 124029–00–1) are subject to (a)(2) of this section. reporting under this section for the sig- (2) The significant new use is: nificant new uses described in para- (i) Release to water. Requirements as graph (a)(2) of this section. specified in § 721.90 (a)(1), (b)(1), (c)(1). (2) The significant new uses are: (ii) [Reserved] (i) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(1), (b)(1), and sions of subpart A of this part apply to (c)(1). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. The following rec- sions of subpart A of this part apply to ordkeeping requirements are applicable this section except as modified by this to manufacturers, importers, and proc- paragraph. essors of this substance, as specified in (1) Recordkeeping. Recordkeeping re- § 721.125 (a), (b), (c), and (k). quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), and (k) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. these substances. [56 FR 19242, Apr. 25, 1991; 56 FR 29903, July (2) Limitations or revocation of certain 1, 1991. Redesignated at 58 FR 29947, May 24, notification requirements. The provisions 1993, as amended at 58 FR 34204, June 23, 1993] of § 721.185 apply to this section. [59 FR 27482, May 27, 1994] § 721.1630 1,2-Ethanediol bis(4- methylbenzenesulfonate); 2,2- § 721.1637 1,2-Propanediol, 3-(2- oxybis-ethane bis(4- propenyloxy)-, bis(4-methylbenzene methylbenzenesulfonate); ethanol, ′ sulfonate); 2-propanol, 1-[2-[[(4- 2,2 -[oxybis(2,1-ethanediyl oxy)]bis-, methylphenyl)sulfonyl] oxy]ethoxy]- bis(4-methylbenzenesulfonate); eth- ′ 3-(2-propenyloxy)-4- anol, 2,2 -[oxybis (2,1-ethane methylbenzenesulfonate; and 2-pro- diyloxy)] bis-, bis(4- panol, 1-[2-[2-[[(4- methylbenzenesulfonate); ethanol, ′ methylphenyl)sulfonyl]oxy] 2,2 -[[1-[(2-propenyloxy) methyl]-1,2- ethoxy]ethoxy]-3-(2-propenyloxy)-, ethanediyl] bis(oxy)]bis-, bis(4- 4-methylbenzenesulfonate. methylbenzene sulfonate); and ethanol, 2-[1-[[2-[2-[[(4- (a) Chemical substances and significant methylphenyl)sulfonyl] oxy]ethoxy] new uses subject to reporting. (1) The ethoxy]methyl]-2-(2- chemical substances 1,2-propanediol, 3- propenyloxy)ethoxy]-, 4- (2-propenyloxy)-, bis(4- methylbenzenesulfonate. methylbenzenesulfonate) (PMN P-93– (a) Chemical substances and significant 1198, CAS no. 114719–19–6), 2-propanol, 1- new uses subject to reporting. (1) The [2-[[(4- chemical substances 1,2-ethanediol methylphenyl)sulfonyl]oxy]ethoxy]-3- bis(4-methylbenzenesulfonate) (PMN P- (2-propenyloxy)-4- 93–1193, CAS no. 6315–52–2), 2,2-oxybis- methylbenzenesulfonate (PMN P-93– ethane bis(4-methylbenzenesulfonate) 1199, CAS no. 124213–39–4), and 2-pro- (PMN P-93–1194, CAS no. 7460–82–4), eth- panol, 1-[2-[2-[[(4- anol, 2,2′-[oxybis(2,1- methylphenyl)sulfonyl]oxy]

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ethoxy]ethoxy]-3-(2-propenyloxy)-, 4- (b) Specific requirements. The provi- methylbenzenesulfonate (PMN P-93– sions of subpart A of this part apply to 1200, CAS no. 124028–99–5) are subject to this section except as modified by this reporting under this section for the sig- paragraph. nificant new uses described in para- (1) Recordkeeping. Recordkeeping re- graph (a)(2) of this section. quirements as specified in § 721.125 (a), (2) The significant new uses are: (b), (c), and (k) are applicable to manu- (i) Release to water. Requirements as facturers, importers, and processors of specified in § 721.90 (a)(1), (b)(1), and these substances. (c)(1). (2) Limitations or revocation of certain (ii) [Reserved] notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to this section except as modified by this [59 FR 27483, May 27, 1994] paragraph. § 721.1643 Benzenesulfonic acid, amino (1) Recordkeeping. Recordkeeping re- substituted phenylazo-. quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (a) Chemical substance and significant facturers, importers, and processors of new uses subject to reporting. (1) The these substances. chemical substance identified generi- (2) Limitations or revocation of certain cally as a benzenesulfonic acid, amino notification requirements. The provisions substituted phenylazo- (PMN P-95–86) of § 721.185 apply to this section. is subject to reporting under this section for the significant new uses de- [59 FR 27482, May 27, 1994] scribed in paragraph (a)(2) of this section. § 721.1640 3,6,9,12,- Tetraoxatetradecane-1,14-diol, bis(4- (2) The significant new uses are: methylbenzenesulfonate; 3,6,9,13- (i) Industrial, commercial, and con- tetraoxahexadec-15-ene-1,11-diol, sumer activities. Requirements as speci- bis(4-methylbenzenesulfonate); fied in § 721.80(w)(1). 3,6,9,12,16-pentaoxanonadec-18-ene- (ii) [Reserved] 1,14-diol, bis(4-methyl benzenesulfonate); and 3,6,9,12- (b) Specific requirements. The provi- tetraoxatetradecane-1,14-diol, 7-[(2- sions of subpart A of this part apply to propenyloxy)methyl]-, bis(4- this section except as modified by this methylbenzenesulfonate). paragraph. (a) Chemical substances and significant (1) Recordkeeping. Recordkeeping renew uses subject to reporting. (1) The quirements specified in § 721.125 (a), (b), chemical substances 3,6,9,12- (c), and (i) are applicable to manufac- tetraoxatetradecane-1,14-diol, bis(4- turers, importers, and processors of methylbenzenesulfonate (PMN P-93– this substance. 1197, CAS no. 41024–91–3), 3,6,9,13- (2) Limitations or revocation of certain tetraoxahexadec-15-ene-1,11-diol, bis(4- notification requirements. The provisions methylbenzenesulfonate) (PMN P-93– of § 721.185 apply to this section. 1201), 3,6,9,12,16-pentaoxanonadec-18- [60 FR 45081, Aug. 30, 1995] ene-1,14-diol, bis(4-methyl benzenesulfonate) (PMN P-93–1202), and § 721.1645 Benzenesulfonic acid, 4- 3,6,9,12-tetraoxatetradecane-1,14-diol, 7- methyl-, reaction products with [(2-propenyloxy)methyl]-, bis(4- oxirane mono[(C10-16- methylbenzenesulfonate) (PMN P-93– alkyloxy)methyl] derivatives and 1205) are subject to reporting under 2,2,4(or 2,4,4)-trimethyl-1,6– this section for the significant new hexanediamine. uses described in paragraph (a)(2) of (a) Chemical substance and significant this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance benzenesulfonic (i) Release to water. Requirements as acid, 4-methyl-, reaction products with specified in § 721.90 (a)(1), (b)(1), and oxirane mono[(C10-16-alkyloxy)methyl] (c)(1). derivatives and 2,2,4(or 2,4,4)-trimethyl- (ii) [Reserved] 1,6–hexanediamine (PMN P-93–1047,

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CAS no. 147170–38–5) is subject to re- § 721.1650 Alkylbenzenesulfonic acid porting under this section for the sig- and sodium salts. nificant new uses described in para- (a) Chemical substances and significant graph (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substances identified generi- (i) Release to water. Requirements as cally as alkyl benzenesulfonic acid and specified in § 721.90 (a)(1), (b)(1), and sodium salts (PMNs P-88–1783, P-88– (c)(1). 2231, P-88–2237, and P-88–2530) are sub- (ii) [Reserved] ject to reporting under this section for (b) Specific requirements. The provi- the significant new uses described in sions of subpart A of this part apply to paragraph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Hazard communication program. A (1) Recordkeeping. Recordkeeping re- significant new use of this substance is quirements as specified in § 721.125 (a), any manner or method of manufacture, (b), (c), and (k) are applicable to manu- import, or processing associated with facturers, importers, and processors of any use of this substance without pro- this substance. viding risk notification as follows: (2) Limitations or revocation of certain (A) If as a result of the test data re- notification requirements. The provisions quired under the section 5(e) consent of § 721.185 apply to this section. order for this substance, the employer becomes aware that this substance [59 FR 27483, May 27, 1994] may present a risk of injury to human health, the employer must incorporate § 721.1648 Substituted benzenesulfonic acid salt (generic). this new information, and any information on methods for protecting against (a) Chemical substance and significant such risk, into an MSDS as described new uses subject to reporting. (1) The in § 721.72(c) within 90 days from the chemical substance identified generi- time the employer becomes aware of cally as substituted benzenesulfonic the new information. If this substance acid (PMN P-99–1304) is subject to re- is not being manufactured, imported, porting under this section for the sig- processed, or used in the employer’s nificant new use described in paragraph workplace, the employer must add the (a)(2) of this section. new information to an MSDS before (2) The significant new uses are: the substance is reintroduced into the (i) Industrial, commercial, and con- workplace. sumer activities. Requirements as speci- (B) The employer must ensure that fied in § 721.80(j). persons who will receive this substance (ii) [Reserved] from the employer are provided an (b) Specific requirements. The provi- MSDS as described in § 721.72(c) con- sions of subpart A of this part apply to taining the information required under this section except as modified by this paragraph (a)(2)(i)(A) of this section paragraph. within 90 days from the time the em- (1) Recordkeeping. Recordkeeping re- ployer becomes aware of the new infor- quirements as specified in § 721.125(a), mation. (b), (c), and (i) are applicable to manu- (ii) Industrial, commercial, and con- facturers, importers, and processors of sumer activities. Requirements as speci- this chemical substance. fied in § 721.80(q). (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of 721.185 apply to this section. this section except as modified by this paragraph. (3) Determining whether a specific use is subject to this section. The provisions of (1) Recordkeeping requirements. Re- quirements as specified in § 721.125 (a), § 721.1725(b)(1) apply to this section. (h), and (i) are applicable to manufac- [68 FR 70175, Dec. 17, 2003] turers, importers, and processors of this substance.

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(2) Limitations or revocation of certain (b), (c), and (k) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this substance. (3) Determining whether a specific use is (2) Limitations or revocation of certain subject to this section. The provisions of notification requirements. The provisions § 721.1725(b)(1) apply to this section. of § 721.185 apply to this section. [57 FR 44062, Sept. 23, 1993, as amended at 58 [65 FR 367, Jan. 5, 2000] FR 29946, May 24, 1993; 58 FR 34204, June 23, 1993] § 721.1660 Benzidine-based chemical substances. § 721.1655 Alkylbenzenesulfonic acid (generic). (a) Chemical substances and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The benzidine-based chemical substances chemical substance identified generi- listed in table 1 of this section are sub- cally as alkylbenzenesulfonic acid ject to reporting under this section for (PMN P-98–679) is subject to reporting the significant new uses described in under this section for the significant paragraph (a)(2) of this section. new use described in paragraph (a)(2) of (2) The significant new uses are any this section. use other than as a reagent to test for (2) The significant new uses are: hydrogen peroxide in milk; a reagent (i) Release to water. Requirements as to test for hydrogen sulfate, hydrogen specified in § 721.90 (a)(1), (b)(1), and cyanide, and nicotine; a stain in mi- (c)(1). croscopy; a reagent for detecting blood; (ii) [Reserved] an analytical standard; and also for (b) Specific requirements. The provi- Colour Index (C.I.) Direct Red 28 sions of subpart A of this part apply to (Congo Red, CAS No. 573-58-0) as an in- this section except as modified by this dicator dye. paragraph. (b) List of substances. The following (1) Recordkeeping. Recordkeeping re- table 1 lists the benzidine-based chem- quirements as specified in § 721.125 (a), ical substances covered by this section.

TABLE 1—BENZIDINE-BASED CHEMICAL SUBSTANCES

CAS number C.I. name C.I. number Chemical Name

92–87–5 Benzidine 0N/A [1,1′-Biphenyl]-4,4′-diamine 531–85–1 Benzidine · 2HCL N/A [1,1′-Biphenyl]-4,4′-diamine, dihydrochloride 573–58–0 C.I. Direct Red 28 22120 1- Naphthalenesulfonic acid, 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[4- amino-, disodium salt 1937–37–7 C.I. Direct Black 38 30235 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4′-[(2, 4- diaminophenyl)azo][1,1′-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt 2302–97–8 C.I. Direct Red 44 22500 1-Naphthalenesulfonic acid, 8,8′-[[1,1′-biphenyl] -4,4′-diylbis(azo)]bis[7-hydroxy-, disodium salt 2429–73–4 C.I. Direct Blue 2 22590 2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4′-[(7-amino-1-hydroxy-3- sulfo-2-naphthalenyl)azo][1,1′-biphenyl]-4-yl]azo]-4-hydroxy-, trisodium salt 2429–79–0 C.I. Direct Orange 8 22130 Benzoic acid, 5-[[4′-[(1-amino-4-sulfo-2-naphthalenyl)azo][1,1′-biphenyl]-4- yl]azo]-2- hydroxy-, disodium salt 2429–81–4 C.I. Direct Brown 31 35660 Benzoic acid, 5-[[4′-[[2,6-diamino-3-[[8-hydroxy-3,6-disulfo-7-[(4-sulfo-1- naphthalenyl)azo]-2-naphthalenyl]azo]-5-methylphenyl]azo][1,1′- biphenyl]-4-yl]azo]-2-hydroxy-, tetrasodium salt 2429–82–5 C.I. Direct Brown 2 22311 Benzoic acid, 5-[[4′-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1′- biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt 2429–83–6 C.I. Direct Black 4 30245 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4′-[(2,4-diamino-5- methylphenyl)azo][1,1′-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt 2429–84–7 C.I. Direct Red 1 22310 Benzoic acid, 5-[[4′-[(2-amino-8-hydroxy-6-sulfo-1-naphthalenyl)azo][1,1′- biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt 2586–58–5 C.I. Direct Brown 1:2 30110 Benzoic acid, 5-[[4′-[[2,6-diamino-3-methyl-5-[(4- sulfophenyl)azo]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt 2602–46–2 C.I. Direct Blue 6 22610 2,7-Naphthalenedisulfonic acid, 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[5- amino-4-hydroxy-, tetrasodium salt 2893–80–3 C.I. Direct Brown 6 30140 Benzoic acid, 5-[[4′-[[2,4-dihydroxy-3- [(4-sulfophenyl)azo]phenyl]azo][1,1′- biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt

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TABLE 1—BENZIDINE-BASED CHEMICAL SUBSTANCES—Continued

CAS number C.I. name C.I. number Chemical Name

3530–19–6 C.I. Direct Red 37 22240 1,3-Naphthalenedisulfonic acid, 8-[[4′-[(4-ethoxyphenyl)azo][1,1′-biphenyl]- 4-yl]azo]-7-hydroxy-, disodium salt 3567–65–5 C.I. Acid Red 85 22245 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4′-[[4-[[(4- methylphenyl)sulfonyl]oxy]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-, disodium salt 3626–28–6 C.I. Direct Green 1 30280 2,7-Naphthalenedisulfonic acid, 4-amino-5- hydroxy-3-[[4′-[(4- hydroxyphenyl)azo][1,1′- biphenyl]-4-yl]azo]-6-(phenylazo)-, disodium salt 3811–71–0 C.I. Direct Brown 1 30045 Benzoic acid, 5-[[4′-[[2,4-diamino-5-[(4- sulfophenyl)azo]phenyl]azo][1,1′- biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt 4335–09–5 C.I. Direct Green 6 30295 2,7-Naphthalenedisulfonic acid, 4-amino-5- hydroxy-6-[[4′-[(4- hydroxyphenyl)azo][1,1′-biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo]-, disodium salt 6358–80–1 C.I. Acid Black 94 30336 2,7-Naphthalenedisulfonic acid, 4-amino-5- hydroxy-3-[[4′-[[4-hydroxy-2- [(2-methylphenyl)amino]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-6-[(4- sulfophenyl)azo]-, trisodium salt 6360–29–8 C.I. Direct Brown 27 31725 Benzoic acid, 5-[[4′-[[4-[(4-amino-7-sulfo-1- naphthalenyl)azo]-6-sulfo-1- naphthalenyl]azo][1,1′-biphenyl]-4-yl]azo]-2-hydroxy-, trisodium salt 6360–54–9 C.I. Direct Brown 30120 Benzoic acid, 5-[[4′-[[2,6-diamino-3-methyl-5-[(4- 154 sulfophenyl)azo]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-2-hydroxy-3-methyl- , disodium salt 8014–91–3 C.I. Direct Brown 74 36300 Benzoic acid, 3,3′-[(3,7-disulfo-1,5- naphthalenediyl)bis[azo(6-hydroxy-3,1- phenylene)azo[6(or7)-sulfo-4,1-naphthalenediyl]azo[1,1′-biphenyl]-4,4′- diylazo]]bis[6-hydroxy-, hexasodium salt 16071–86–6 C.I. Direct Brown 95 30145 Cuprate(2-), [5-[[4′-[[2,6-dihydroxy-3-[(2-hydroxy- 5- sulfophenyl)azo]phenyl]azo][1,1′-biphenyl] -4-yl]azo]-2- hydroxybenzoato(4-)]-, disodium

[61 FR 52295, Oct. 7, 1996]

§ 721.1675 Disulfonic acid rosin amine of § 721.185 apply to this significant new salt of a benzidine derivative (ge- use rule. neric name). [55 FR 33304, Aug. 15, 1990. Redesignated at 58 (a) Chemical substance and significant FR 29946, May 24, 1993, as amended at 58 FR new uses subject to reporting. (1) The 34204, June 23, 1993] chemical substance identified generically as disulfonic acid rosin amine § 721.1680 Substituted benzoic acid (generic). salt of a benzidine derivative (PMN P- 87–1337) is subject to reporting under (a) Chemical substance and significant this section for the significant new new uses subject to reporting. (1) The uses described in paragraph (a)(2) of chemical substance identified generi- this section. cally as substituted benzoic acid (PMN (2) The significant new uses are: P-01–423) is subject to reporting under this section for the significant new use (i) Industrial, commercial, and con- described in paragraph (a)(2) of this sumer activities. Requirements as speci- section. fied in § 721.80 (f), (v)(1), (w)(1), and (2) The significant new uses are: (x)(1). (i) Industrial, commercial, and con- (ii) [Reserved] sumer activities. Requirements as speci- (b) Specific requirements. The provi- fied in § 721.80(f). sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. The following rec- this section except as modified by this ordkeeping requirements are applicable paragraph. to manufacturers, importers, and proc- (1) Recordkeeping. Recordkeeping re- essors of this substance, as specified in quirements as specified in § 721.125(a), § 721.125 (a), (b), (c), and (i). (b), (c), and (i) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this chemical substance.

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(2) Limitations or revocation of certain § 721.1705 Benzoic acid, 3-amino-, notification requirements. The provisions diazotized, coupled with 6-amino-4- of § 721.185 apply to this section. hydroxy-2-naphthalenesulfonic acid, diazotized, (3- [68 FR 70175, Dec. 17, 2003] aminophenyl)phosphonic acid and diazotized 2,5- § 721.1700 Halonitrobenzoic acid, sub- diethoxybenzenamine. stituted (generic name). (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance generically identi- chemical substance halonitrobenzoic fied as benzoic acid, 3-amino-, acid, substituted (PMN P-86–1098) is diazotized, coupled with 6-amino-4-hy- subject to reporting under this section droxy-2-naphthalenesulfonic acid, for the significant new uses described diazotized, (3-amino-phenyl)phosphonic in paragraph (a)(2) of this section. acid and diazotized 2,5- (2) The significant new uses are: diethoxybenzenamine (PMN P-96–1216; (i) Protection in the workplace. Re- CAS No. 163879–69–4) is subject to requirements as specified in § 721.63 (a)(1), porting under this section for the sig- (a)(3), (a)(4), (a)(5)(iv) through nificant new uses described in para- (a)(5)(vii), (a)(6)(i), (b) (concentration graph (a)(2) of this section. set at 1.0 percent), and (c). (2) The significant new uses are: (ii) Hazard communication program. (i) Industrial, commercial, and con- Requirements as specified in § 721.72 (b), sumer activities. Requirements as speci- (c), (d), (e) (concentration set at 1.0 fied in § 721.80 (v)(1), (w)(1), and (x)(1). percent), (f) and (g)(1)(vi), (g)(2)(i) (ii) [Reserved] through (g)(2)(v), and (g)(5). The provi- (b) Specific requirements. The provision of § 721.72(d) requiring that em- sions of subpart A of this part apply to ployees to be provided with informa- this section except as modified by this tion on the location and availability of paragraph. (1) Recordkeeping re- a written hazard communication pro- Recordkeeping. quirements as specified in § 721.125 (a), gram does not apply when the written (b), (c), and (i) are applicable to manu- program is not required under facturers, importers, and processors of § 721.72(a). this substance. (iii) Industrial, commercial, and con- (2) Limitations or revocation of certain sumer activities. Requirements as speci- notification requirements. The provisions fied in § 721.80(k). of § 721.185 apply to this section. (iv) Disposal. Requirements as specified in § 721.85 (a)(1), (b)(1), and (c)(1). [63 FR 3423, Jan. 22, 1998] (b) Specific requirements. The provi- § 721.1725 Benzoic acid, 3,3′-methyl- sions of subpart A of this part apply to enebis [6 amino-, di-2-propenyl this section except as modified by this ester. paragraph. (a) Chemical substance and significant (1) Recordkeeping. The following rec- new uses subject to reporting. (1) The fol- ordkeeping requirements are applicable lowing chemical substance, referred to to manufacturers, importers, and proc- by its CAS Number and chemical name, essors of this substance, as specified in is subject to reporting under this sec- § 721.125 (a) through (c), (e) through (g) tion for the significant new uses de- and (j). scribed in paragraph (a)(2) of this sec- (2) Limitations or revocation of certain tion: 61386–02–5, Benzoic acid, 3,3′- notification requirements. The provisions methylenebis [6 amino-, di-2-propenyl of § 721.185 apply to this significant new ester. use rule. (2) The significant new uses are: (i) (3) Determining whether a specific use is Any use other than the use described in subject to this section. The provisions of Premanufacture Notice P-82–438. § 721.1725(b)(1) apply to this section. (ii) Any manner or method of manu- [55 FR 32416, Aug. 9, 1990. Redesignated and facturing or processing the substance amended at 58 FR 29946, 29947, May 24, 1993; 58 for the use described in Premanufac- FR 34204, June 23, 1993] ture Notice P-82–438 different than the

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manner or method described in (vi) EPA will answer an inquiry on Premanufacture Notice P-82–438. whether a particular use is subject to (b) Special provisions. The provisions this section within 30 days after receipt of subpart A of this part apply to this of a complete submission under para- section except as modified by this graph (b)(1) of this section. paragraph. (2) [Reserved] (1) Determining whether a specific use is [51 FR 16687, May 6, 1986. Redesignated at 53 subject to this rule. (i) A person who in- FR 2845, Feb. 2, 1988. Further redesignated at tends to manufacture, import, or proc- 58 FR 29946, May 24, 1993, as amended at 58 ess the chemical substance identified FR 34204, June 23, 1993] in paragraph (a)(1) of this section may ask EPA whether the use for which the § 721.1728 Benzoic acid, 2-(3- phenylbutylidene)amino-, methyl person intends to manufacture, import, ester. or process the substance is a significant new use under paragraph (a)(2)(i) (a) Chemical substance and significant of this section. EPA will answer such new uses subject to reporting. (1) The an inquiry only if EPA determines that chemical substance identified as ben- the person has a bona fide intent to zoic acid, 2-(3-phenylbutylidene)amino- , methyl ester (PMN P-85–1211) is sub- manufacture, import, or process the ject to reporting under this section for chemical substance. the significant new uses described in (ii) To establish a bona fide intent to paragraph (a)(2) of this section. manufacture, import, or process the (2) The significant new uses are: chemical substance, the person must (i) Industrial, commercial, and con- submit to EPA: sumer activities. Requirements as speci- (A) All materials and statements re- fied in § 721.80(p) (10,600 kg). quired under § 721.6. (ii) [Reserved] (B) The specific use for which the (b) Specific requirements. The provi- person intends to manufacture, import, sions of subpart A of this part apply to or process the chemical substance. this section except as modified by this (iii) EPA will review the information paragraph. submitted by the person under this (1) Recordkeeping. Recordkeeping re- paragraph to determine whether the quirements as specified in § 721.125 (a) person has a bona fide intent to manu- and (i) are applicable to manufactur- facture, import, or process the chem- ers, importers, and processors of this ical substance. substance. (iv) If EPA determines that the per- (2) Limitations or revocation of certain son has a bona fide intent to manufac- notification requirements. The provisions ture, import, or process the chemical of § 721.185 apply to this section. substance, EPA will tell the person [58 FR 51682, Oct. 4, 1993] whether the use for which the person

intends to manufacture, import, or § 721.1729 Boric acid (H3BO3), mixed process the substance is a significant esters with polyethylene glycol new use under paragraph (a)(2)(i) of mono-Bu ether and polyethylene this section. If EPA tells the person glycol mono Me ether. that the intended use is not a signifi- (a) Chemical substance and significant cant new use under paragraph (a)(2)(i) new uses subject to reporting. (1) The of this section, EPA will tell the person chemical substance identified as boric what activities would constitute a sig- acid (H3BO3), mixed esters with poly- nificant new use under paragraph ethylene glycol mono-Bu ether and pol- (a)(2)(ii) of this section. yethylene glycol mono Me ether (PMN (v) A disclosure to a person with a P-97–635; CAS No. 183290–62–2) is subject bona fide intent to manufacture, im- to reporting under this section for the port, or process the chemical substance significant new uses described in para- of the significant new uses subject to graph (a)(2) of this section. this section will not be considered pub- (2) The significant new uses are: lic disclosure of confidential business (i) Protection in the workplace. Re- information under section 14 of the quirements as specified in § 721.63 Act. (a)(2)(i) and (a)(3).

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(ii) Release to water. Requirements as subject to reporting under this section specified in § 721.90 (a)(4), (b)(4), and for the significant new uses described (c)(4) (N=300). in paragraph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 paragraph. (a)(2)(i) and (a)(3). (1) Recordkeeping. Recordkeeping re- (ii) Release to water. Requirements as quirements as specified in § 721.125 (a), specified in § 721.90 (a)(4), (b)(4), and (b), (c), (d), (e), and (k) are applicable (c)(4) (N=300). to manufacturers, importers, and proc- (b) Specific requirements. The provi- essors of this substance. sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this section. (1) Recordkeeping. Recordkeeping re- [65 FR 368, Jan. 5, 2000] quirements as specified in § 721.125 (a), (b), (c), (d), (e), and (k) are applicable α § 721.1730 Poly(oxy-1,2-ethanediyl), - to manufacturers, importers, and proc- butyl-w-hydroxy, ester with boric essors of this substance. acid (H BO ). 3 3 (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified as poly(oxy-1,2-ethanediyl), a-butyl-w-hy- [65 FR 368, Jan. 5, 2000] droxy, ester with boric acid (H3BO3) (PMN P-97–636; CAS No. 106008–93–9) is § 721.1732 Nitrobenzoic acid octyl subject to reporting under this section ester. for the significant new uses described (a) Chemical substance and significant in paragraph (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified as (i) Protection in the workplace. Re- nitrobenzoic acid octyl ester (PMN P- quirements as specified in § 721.63 93–343) is subject to reporting under (a)(2)(i) and (a)(3). this section for the significant new (ii) Release to water. Requirements as uses described in paragraph (a)(2) of specified in § 721.90 (a)(4), (b)(4), and this section. (c)(4) (N=300). (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(4), (b)(4), and this section except as modified by this (c)(4) (where N = 1 ppb). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), (d), (e), and (k) are applicable this section except as modified by this to manufacturers, importers, and proc- paragraph. essors of this substance. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (k) are applicable to manufacturers, importers, and processors of [65 FR 368, Jan. 5, 2000] this substance. α (2) Limitations or revocation of certain § 721.1731 Poly(oxy-1,2-ethanediyl), - notification requirements. The provisions methyl-w-hydroxy, ester with boric of § 721.185 apply to this section. acid (H3BO3). (a) Chemical substance and significant [58 FR 51682, Oct. 4, 1993] new uses subject to reporting. (1) The chemical substance identified as § 721.1734 Substituted benzonitrile (ge- poly(oxy-1,2-ethanediyl), a-methyl-w- neric). hydroxy, ester with boric acid (H3BO3) (a) Chemical substance and significant (PMN P-97–637; CAS No. 106008–94–0) is new uses subject to reporting. (1) The

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chemical substance identified generi- program is not required under cally as a substituted benzonitrile § 721.72(a). (PMN P-97–1029) is subject to reporting (iii) Industrial, commercial, and con- under this section for the significant sumer activities. Requirements as speci- new uses described in paragraph (a)(2) fied in § 721.80 (k) (light stabilizer for of this section. polymers) and (q). (2) The significant new uses are: (b) Specific requirements. The provi- (i) Protection in the workplace. Re- sions of subpart A of this part apply to quirements as specified in § 721.63 this section except as modified by this (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii), paragraph. (a)(5)(iv), (a)(5)(v), and (a)(6)(v). (1) Recordkeeping. The following rec- (ii) Industrial, commercial, and con- ordkeeping requirements are applicable sumer activities. Requirements as speci- to manufacturers, importers, and proc- fied in § 721.80(g). essors of this substance, as specified in (iii) Release to water. Requirements as § 721.125 (a) through (c), (e) through (g), specified in § 721.90 (a)(1), (b)(1), and and (i). (c)(1). (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this significant new this section except as modified by this use rule. paragraph. (3) Determining whether a specific use is (1) Recordkeeping. The recordkeeping subject to this section. The provisions of requirements specified in § 721.125 (a), § 721.1725(b)(1) apply to this section. (b), (c), (d), (e), (i), and (k) are applica- [55 FR 21413, Aug. 9, 1990. Redesignated and ble to manufacturers, importers, and amended at 58 FR 29946, May 24, 1993; 58 FR processors of this substance. 34204, June 23, 1993] (2) Limitations or revocation of certain notification requirements. The provisions § 721.1738 Substituted benzotriazole of § 721.185 apply to this section. (generic name). [63 FR 44576, Aug. 20, 1998] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.1735 Alkylbisoxyalkyl (substitut- chemical substance identified generi- ed-1,1-dimethylethylphenyl) benzo- cally as a substituted benzotriazole triazole (generic name). (PMN P-94–1744) is subject to reporting (a) Chemical substance and significant under this section for the significant new uses subject to reporting. (1) The new uses described in paragraph (a)(2) chemical substance alkylbisoxyalkyl of this section. (substituted-1,1-dimethylethylphenyl) (2) The significant new uses are: benzotriazole (PMN P-86–1771) is sub- (i) Protection in the workplace. Re- ject to reporting under this section for quirements as specified in § 721.63 (a)(1), the significant new uses described in (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), paragraph (a)(2) of this section. (a)(6)(i), (b) (concentration set at 1.0%), (2) The significant new uses are: and (c). (i) Protection in the workplace. Re- (ii) Hazard communication program. quirements as specified in § 721.63 (a)(1), Requirements as specified in § 721.72 (a), (a)(3), (a)(4), (a)(5)(iv) through (b), (c), (d), (e) (concentration set at (a)(5)(vii), (a)(6)(i), (b) (concentration 1.0%), (f), (g)(1)(iv), (g)(1)(vi), (g)(2)(i), set at 1.0 percent), and (c). (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (ii) Hazard communication program. and (g)(5). Requirements as specified in § 721.72 (iii) Industrial, commercial, and con- (b)(2), (c), (d), (e) (concentration set at sumer activities. Requirements as speci- 1.0 percent), (f) and (g)(1)(iv), (g)(2)(i) fied in § 721.80(q). through (g)(2)(v), and (g)(5). The provi- (b) Specific requirements. The provision of § 721.72(d) requiring that em- sions of subpart A of this part apply to ployees be provided with information this section except as modified by this on the location and availability of a paragraph. written hazard communication pro- (1) Recordkeeping. Recordkeeping re- gram does not apply when the written quirements specified in § 721.125(a)

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through (i) are applicable to manufac- (i) Industrial, commercial, and con- turers, importers, and processors of sumer activities. Requirements as speci- this substance. fied in § 721.80(f). (2) Limitations or revocation of certain (ii) Release to water. Requirement as notification requirements. The provisions specified § 721.90(b)(1) and (c)(1). of § 721.185 apply to this section. (b) Specific requirements. The provi- (3) Determining whether a specific use is sions of subpart A of this part apply to subject to this section. The provisions of this section except as modified by this § 721.1725(b)(1) apply to this section. paragraph. (1) Recordkeeping. Recordkeeping re- [61 FR 63736, Dec. 2, 1996] quirements as specified in § 721.125(a), § 721.1745 Ethoxybenzothiazole disul- (b), (c), (i), and (k) are applicable to fide. manufacturers, importers, and processors of this chemical substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance generically identi- of § 721.185 apply to this section. fied as ethoxybenzothiazole disulfide (PMN P-90–1384) is subject to reporting [68 FR 70175, Dec. 17, 2003] under this section for the significant new uses described in paragraph (a)(2) § 721.1750 1H-Benzotriazole, 5-(pentyl- of this section. oxy)- and 1H-benzotriazole, 5-(pentyloxy)-, sodium and potassium (2) The significant new uses are: salts. (i) Protection in the workplace. Re- quirements as specified in § 721.63 (a)(4), (a) Chemical substance and significant (a)(5)(i) through (vii), (a)(6)(i), (b) (con- new uses subject to reporting. (1) The centration set at 0.1 percent), and (c). chemical substances 1H-benzotriazole, (ii) Hazard communication program. 5-(pentyloxy)- (PMN P-92–34, CAS no. Requirements as specified in § 721.72 (a), 133145–29–6), 1H-benzotriazole, 5-(pen- (b), (c), (d), (e) (concentration set at 0.1 tyloxy)-, sodium salt (PMN P-92–35), percent), (f), (g)(1)(vii), (g)(2)(ii), and 1H-benzotriazole, 5-(pentyloxy)- , (g)(2)(iii), (g)(2)(iv), and (g)(5). potassium salt (PMN P-92–36) are sub- (b) Specific requirements. The provi- ject to reporting for the significant sions of subpart A of this part apply to new uses described in paragraph (a)(2) this section except as modified by this of this section. paragraph. (2) The significant new uses are: (1) Recordkeeping requirements. Re- (i) Hazard communication program. A quirements as specified in § 721.125 (a) significant new use of these substances through (d) and (f) through (i) are ap- is any manner or method of manufac- plicable to manufacturers, importers, ture, import, or processing associated and processors of this substance. with any use of these substances with- (2) Limitations or revocation of certain out providing risk notification as fol- notification requirements. The provisions lows: of § 721.185 apply to this section. (A) If as a result of the test data required under the section 5(e) consent [57 FR 44063, Sept. 23, 1992, as amended at 58 order for these substances, the em- FR 34204, June 23, 1993] ployer becomes aware that these substances may present a risk of injury to § 721.1747 Substituted benzophenone the environment, the employer must (generic). incorporate this new information, and (a) Chemical substance and significant any information on methods for pro- new uses subject to reporting. (1) The tecting against such risk, into a MSDS chemical substance identified generi- as described in § 721.72(c) within 90 days cally as a substituted benzophenone from the time the employer becomes (PMN P-02–262) is subject to reporting aware of the new information. If these under this section for the significant substances are not being manufac- new use described in paragraph (a)(2) of tured, imported, processed, or used in this section. the employer’s workplace, the em- (2) The significant new uses are: ployer must add the new information

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to an MSDS before the substances are (iii) Industrial, commercial, and con- reintroduced into the workplace. sumer activities. Requirements as speci- (B) The employer must ensure that fied in § 721.80 (l) and (q). persons who will receive, or who have (b) Specific requirements. The provi- received these substances from the em- sions of subpart A of this part apply to ployer within 5 years from the date the this section except as modified by this employer becomes aware of the new in- paragraph. formation described in paragraph (1) Recordkeeping requirements. Rec- (a)(2)(i)(A) of this section, are provided ordkeeping requirements specified in an MSDS as described in § 721.72(c) con- § 721.125 (a), (b), (c), (d), (f), (g), (h), and taining the information required under (i) are applicable to manufacturers, im- paragraph (a)(2)(i)(A) of this section porters, and processors of this sub- within 90 days from the time the em- stance. ployer becomes aware of the new infor- (2) Limitations or revocation of certain mation. notification requirements. The provisions (ii) Industrial, commercial consumer ac- of § 721.185 apply to this section. tivities. Requirements as specified in (3) Determining whether a specific use is § 721.80(p) (limit set at 9,500 kg). subject to this section. The provisions of (b) Specific requirements. The provi- § 721.1725(b)(1) apply to this section. sions of subpart A of this part apply to [60 FR 11041, Mar. 1, 1995] this section except as modified by this paragraph. § 721.1760 Substituted benzotriazole (1) Recordkeeping. Recordkeeping re- derivatives. quirements as specified in § 721.125 (a) (a) Chemical substances and significant through (i) are applicable to manufac- new uses subject to reporting. (1) The turers, importers, and processors of chemical substances identified generi- this substance. The following record- cally as substituted benzotriazole de- keeping requirements are applicable to rivatives (PMNs P-93–374 and P-93–375) manufacturers, importers, and proc- are subject to reporting under this sec- essors of these substances, as specified tion for the significant new uses de- in § 721.125 (a), (c), and (i). scribed in paragraph (a)(2) of this sec- (2) Limitations or revocation of certain notification requirements. The provisions tion. (2) The significant new uses are: of § 721.185 apply to this section. (i) Protection in the workplace. Re- [58 FR 32237, June 8, 1993] quirements as specified in § 721.63 (a)(1), (b) (concentration set at 1.0 percent), § 721.1755 Methylenebisbenzotriazole. and (c). (a) Chemical substance and significant (ii) Hazard communication program. new uses subject to reporting. (1) The Requirements as specified in § 721.72 (a), chemical substance (b), (c), (d), (e) (concentration set at 1.0 methylenebisbenzotriazole (P-93–578) is percent), (f), (g)(1)(i), (g)(1)(iv), subject to reporting under this section (g)(1)(vi), (g)(2)(i), (g)(2)(v), and (g)(5). for the significant new uses described (iii) Industrial, commercial, and con- in paragraph (a)(2) of this section. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80 (g), (v)(1), (w)(1), and (i) Protection in the workplace. During (x)(1). both manufacture and use of the sub- (iv) Release to water. Requirements as stance, requirements as specified in specified in § 721.90 (a)(1), (b)(1), and § 721.63 (a)(4), (a)(6)(i), (b) (concentra- (c)(1). tion set at 1.0 percent) and (c). During (b) Specific requirements. The provi- manufacture of the PMN substance sions of subpart A of this part apply to § 721.63(a)(5)(i); during use of the PMN this section except as modified by this substance § 721.63 (a)(5)(iii), (a)(5)(iv), paragraph. (a)(5)(v), (a)(5)(vi), and (a)(5)(vii). (1) Recordkeeping requirements. Rec- (ii) Hazard communication program. ordkeeping requirements specified in Requirements as specified in § 721.72 (a), § 721.125 (a), (b), (c), (d), (f), (g), (h), (i), (b), (c), (d), (e) (concentration set at 1.0 and (k) are applicable to manufactur- percent), (f), (g)(1)(iv), (g)(1)(vi), ers, importers, and processors of these (g)(2)(iii), (g)(2)(iv), and (g)(5). substances.

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(2) Limitations or revocation of certain (3) Determining whether a specific use is notification requirements. The provisions subject to this section. The provisions of of § 721.185 apply to this section. § 721.1725(b)(1) apply to this section. [60 FR 11041, Mar. 1, 1995] [56 FR 19235, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, May 24, 1993; 58 FR § 721.1765 2-Substituted benzotriazole. 34204, June 23, 1993; 60 FR 30468, June 9, 1995; 63 FR 45955, Aug. 28, 1998] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.1767 Substituted 6,6′-(1- chemical substance identified generi- methylethylidene)bis[3,4-dihydro-3- cally as 2-substituted benzotriazole phenyl-1,3-benzoxazine] (generic). (PMN P-90–335) is subject to reporting (a) Chemical substance and significant under this section for the significant new uses subject to reporting. (1) The new uses described in paragraph (a)(2) chemical substance identified generi- of this section. cally as substituted 6,6′-(1- (2) The significant new uses are: methylethylidene)bis[3,4-dihydro-3- (i) Protection in the workplace. Re- phenyl-1,3-benzoxazine] (PMN P-00– quirements as specified in § 721.63 (a)(1), 0993) is subject to reporting under this (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), section for the significant new uses de- (a)(5)(v), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) scribed in paragraph (a)(2) of this sec- (concentration set at 1.0 percent), and tion. (c). (2) The significant new uses are: (ii) Hazard communication program. (i) Release to water. Requirements as Requirements as specified in § 721.72 (a), specified in § 721.90 (a)(1), (b)(1), and (b), (c), (d), (e) (concentration set at 1.0 (c)(1). percent), (f), (g)(1)(i), (g)(1)(ii), (ii) [Reserved] (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), (g)(2)(i), (b) Specific requirements. The provi- (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5). sions of subpart A of this part apply to (iii) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80 (l) and (q). (1) Recordkeeping. Recordkeeping re- (iv) Release to water. Requirements as quirements as specified in § 721.125 (a), specified in § 721.90 (a)(4), (b)(4), (c)(4), (b), (c), and (k) are applicable to manu- (where N = 80 ). However, contrary to facturers, importers, and processors of § 721.91(a)(4), if the waste stream con- this substance. taining the PMN substance will be (2) Limitations or revocation of certain treated using biological treatment (ac- notification requirements. The provisions tivated sludge or equivalent) plus clari- of § 721.185 apply to this section. fication, then the amount of PMN substance reasonably likely to be removed [68 FR 15081, Mar. 28, 2003] from the waste stream by such treatment may be subtracted in calculating § 721.1775 6-Nitro-2(3H)-benzoxazo- the number of kilograms released. No lone. more than 75 percent removal effi- (a) Chemical substances and significant ciency may be attributed to such treat- new uses subject to reporting. (1) The ment. chemical substance 6-nitro-2(3H)- (b) Special requirements. The provi- benzoxazolone (PMN P-84–963) is sub- sions of subpart A of this part apply to ject to reporting under this section for this section except as modified by this the significant new uses described in paragraph. paragraph (a)(2) of this section. (1) Recordkeeping. The following rec- (2) The significant new uses are: ordkeeping requirements are applicable (i) Protection in the workplace. Re- to manufacturers, importers, and proc- quirements as specified in § 721.63 (a)(1), essors of this substance: § 721.125 (a) (a)(3), (b) (concentration set at 0.1 per- through (i), and (k). cent), and (c). (2) Limitations or revocation of certain (ii) Hazard communication program. notification requirements. The provisions Requirements as specified in § 721.72 (a), of § 721.185 apply to this significant new (e) (concentration set at 0.1 percent), use rule. (f), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), and

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(g)(2)(v). The provisions of § 721.72(g) rein commerce must submit a significant quiring placement of specific informa- new use notice. tion on a label and MSDS do not apply (B) [Reserved] when a label and MSDS are not re- (2) The chemical substance identified quired under § 721.72 (b) and (c), respec- as 1,1′-(Biphenyl, 4-bromo- (CAS No. 92– tively. 66–0) is subject to reporting under this (iii) Industrial, commercial, and con- section for the significant new uses de- sumer activities. Requirements as speci- scribed in paragraph (a)(2)(i) of this fied in § 721.80 (v)(1), (w)(1), (x)(1), and section. (y)(2). (i) The significant new uses are: (iv) Release to water. Requirements as (A) Industrial, commercial, and con- specified in § 721.90 (a)(1), (b)(1), and sumer activites. Requirements as speci- (c)(1). fied in § 721.80 (f), (j), and (s) (10,000 (b) Specific requirements. The provi- kilograms). sions of subpart A of this part apply to (B) Release to water. Requirements as this section except as modified by this specified in § 721.90 (a)(1), (b)(1), and paragraph. (c)(1). (1) Recordkeeping. The following rec- (ii) Specific requirements. The provi- ordkeeping requirements are applicable sions of subpart A of this part apply to to manufacturers, importers, and proc- this section except as modified by this essors of this substance, as specified in paragraph. § 721.125 (d), (e), (f), and (i). (A) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), (i), and (k) are applicable to of § 721.185 apply to this section. manufacturers, importers, and processors of this substance. [55 FR 26100, June 26, 1990. Redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR (B) Limitations or revocation of certain 34204, June 23, 1993] notification requirements. The provisions of § 721.185 apply to this section. § 721.1790 Polybrominated biphenyls. (C) Determining whether a specific use (a) Chemical substances and significant is subject to this section. The provisions new uses subject to reporting. (1) The of § 721.1725(b)(1) apply to this section. chemical substances identified as 1,1′- (b) [Reserved] (Biphenyl, 4,4′-dibromo- (CAS No. 92–86– [63 FR 45955, Aug. 28, 1998] 4); 1,1′-(Biphenyl, 2-bromo- (CAS No. 2052–07–5); 1,1′-(Biphenyl, 3-bromo- § 721.1800 3,3′,5,5′-Tetramethylbi- (CAS No. 2113–57–7); 1,1′-(Biphenyl, 2,2′, phenyl-4,4′-diol. 3,3′, 4,4′, 5,5′, 6,6′-decabromo- (CAS No. (a) Chemical substances and significant 13654–09–6); Nonabromobiphenyl (CAS new uses subject to reporting. (1) The No. 27753–52–2); Octabromobiphenyl chemical substance identified as (CAS No. 27858–07–7); and 3,3′,5,5′-tetramethylbiphenyl-4,4′-diol Hexabromobiphenyl (CAS No. 36355–01– (PMN P-88–972) is subject to reporting 8) are subject to reporting under this under this section for the significant section for the significant new uses de- new uses described in paragraph (a)(2) scribed in paragraph (a)(1)(i) of this of this section. section. (2) The significant new uses are: (i) The significant new use is: Any (i) Protection in the workplace. Re- use. quirements as specified in § 721.63 (a)(4), (ii) Specific requirements. The provi- (a)(5)(vii), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), sions of subpart A of this part apply to (b) (concentration set at 1 percent), and this section except as modified by this (c). paragraph. (ii) Hazard communication program. (A) Persons who must report. Section Requirements as specified in § 721.72 (a), 721.5 applies to this section except for (b), (c), (d), (e) (concentration set at 1 § 721.5(a)(2). A person who intends to percent), (f), (g)(1)(iv), (g)(1)(ix), manufacture, import, or process for (g)(2)(ii), (g)(2)(iv), and (g)(5). commercial purposes a substance iden- (iii) Industrial, commercial, and con- tified in paragraph (a)(1) of this section sumer activities. Requirements as speci- and intends to distribute the substance fied in § 721.80 (k) (monomer for epoxy

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resins and engineering plastics or an uses described in paragraph (a)(2) of antioxidizing agent for lubricating this section. oils) and (p) (level set at 42,000 kg and (2) The significant new uses are: 366,000 kg). (i) Protection in the workplace. Re- (iv) Disposal. Requirements as speci- quirements as specified in § 721.63 (a)(4), fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(6)(i), (c)(1), and (c)(2). (a)(6)(ii), (b) (concentration set at 1.0 (b) Specific requirements. The provi- percent), and (c). sions of subpart A of this part apply to (ii) Hazard communication program. this section except as modified by this Requirements as specified in § 721.72 (a), paragraph. (b), (c), (d), (e) (concentration set at 1.0 (1) Recordkeeping. The following rec- percent), (f), (g)(1) (systemic effects— ordkeeping requirements are applicable depression in body weight gain and to manufacturers, importers, and proc- blood effects), (g)(2)(ii), (g)(2)(iii), essors of this substance, as specified in (g)(2)(iv) (when in dust or mist form), § 721.125 (a) through (j). and (g)(5). (2) Limitations or revocation of certain (iii) Industrial, commercial, and con- notification requirements. The provisions sumer activities. Requirements as speci- of § 721.185 apply to this section. fied in § 721.80(q). (b) Specific requirements. The provi- [55 FR 33308, Aug. 15, 1990. Redesignated at 58 sions of subpart A of this part apply to FR 29947, May 24, 1993, as amended at 58 FR 34204, June 23, 1993] this section except as modified by this paragraph. § 721.1805 Substituted bisaniline. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a) (a) Chemical substance and significant through (d), and (f) through (i) are ap- new uses subject to reporting. (1) The plicable to manufacturers, importers, chemical substance identified generi- and processors of this substance. cally as a substituted bisaniline (PMN (2) Limitations or revocation of certain P-96–1410) is subject to reporting under notification requirements. The provisions this section for the significant new of § 721.185 apply to this significant new uses described in paragraph (a)(2) of use rule. this section. (3) Determining whether a specific use is (2) The significant new uses are: subject to this section. The provisions of (i) Release to water. Requirements as § 721.1725(b)(1) apply to this section. specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 4). [58 FR 32237, June 8, 1993, as amended at 58 (ii) [Reserved] FR 29946, May 24, 1993] (b) Specific requirements. The provi- § 721.1825 Bisphenol A, epichlorohy- sions of subpart A of this part apply to drin, polyalkylenepolyol and poly- this section except as modified by this isocyanato derivative. paragraph. (1) Recordkeeping. Recordkeeping re- (a) Chemical substance and significant quirements as specified in § 721.125 (a), new uses subject to reporting. (1) The (b), (c), and (k) are applicable to manu- chemical substance identified generi- facturers, importers, and processors of cally as bisphenol A, epichlorohydrin, this substance. polyalkylenepolyol and polyisocyanato (2) Limitations or revocation of certain derivative (PMN P-89–750) is subject to notification requirements. The provisions reporting under this section for the sig- of § 721.185 apply to this section. nificant new uses described in paragraph (a)(2) of this section. [63 FR 3423, Jan. 22, 1998] (2) The significant new uses are: (i) Protection in the workplace. Re- § 721.1820 Bisphenol derivative. quirements as specified in § 721.63 (a)(1), (a) Chemical substance and significant (a)(3), (a)(4), (a)(5)(viii), (a)(5)(ix), new uses subject to reporting. (1) The (a)(6)(ii), (a)(6)(v), (b) (concentration chemical substance identified generi- set at 0.1 percent), and (c). cally as bisphenol derivative (PMN No. (ii) Hazard communication program. P-92–509) is subject to reporting under Requirements as specified in § 721.72 (a), this section for the significant new (b), (c), (d), (e) (concentration set at 0.1

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percent), (f) and (g)(1)(vi), (g)(1)(vii), under the section 5(e) consent order for (g)(2)(i) through (g)(2)(v), (g)(3)(ii), this substance, the employer becomes (g)(4)(i), and (g)(5). aware that this substance may present (iii) Industrial, commercial, and con- a risk of injury to human health, the sumer activities. Requirements as speci- employer must incorporate this new in- fied in § 721.80 (l) and (q) (The produc- formation, and any information on tion limit applies to the aggregate pro- methods for protecting against such duction volume of both P-89–750 and P- risk, into a Material Safety Data Sheet 89–760. P-89–760 is the preferred sub- (MSDS) as described in § 721.72(c) with- stance for use in performing these in 90 days from the time the employer tests. Results from such testing can be becomes aware of the new information. used to evaluate the toxicity of P-89– If this substance is not being manufac- 750 as well). tured, imported, processed, or used in (iv) Disposal. Requirements as speci- the employer’s workplace, the em- fied in § 721.85 (b)(1), (b)(2), (c)(1), and ployer must add the new information (c)(2). to an MSDS before the substance is re- (v) Release to water. Requirements as introduced into the workplace. specified in § 721.90 (a)(2)(ii) (Oil and (B) The employer must ensure that grease separation may be used as an al- persons who have received, or will re- ternative treatment), (b)(1), and (c)(1). ceive, this substance from the em- (b) Specific requirements. The provi- ployer are provided an MSDS as de- sions of subpart A of this part apply to scribed in § 721.72(c) containing the in- this section except as modified by this formation required under paragraph paragraph. (a)(2)(i)(A) of this section within 90 (1) Recordkeeping. The following rec- days from the time the employer be- ordkeeping requirements are applicable comes aware of the new information. to manufacturers, importers, and proc- (ii) Industrial, commercial, and con- essors of this substance, as specified in sumer activities. Requirements as speci- § 721.125 (a), (b), (c), (d), (e), (f), (g), (h), fied in § 721.80(q). (i), (j), and (k). (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this significant new paragraph. use rule. (1) Recordkeeping requirements. The (3) Determining whether a specific use is following recordkeeping requirements subject to this section. The provisions of are applicable to manufacturers, im- § 721.1725(b)(1) apply to this section. porters, and processors of this substance, as specified in § 721.125 (a), (c), [55 FR 46772, Nov. 6, 1990. Redesignated and amended at 58 FR 29946, May 24, 1993; 58 FR (h), and (i). 34204, June 23, 1993] (2) Limitations or revocation of certain notification requirements. The provisions § 721.1850 Toluene sulfonamide bis- of § 721.185 apply to this significant new phenol A epoxy adduct. use rule. (a) Chemical substances and significant (3) Determining whether a specific use is new uses subject to reporting. (1) The subject to this section. The provisions of chemical substance identified generi- § 721.1725(b)(1) apply to this section. cally as toluene sulfonamide bisphenol [56 FR 15791, Apr. 17, 1991. Redesignated and A epoxy adduct (PMN P-90–113) is sub- amended at 58 FR 29946, May 24, 1993; 58 FR ject to reporting under this section for 34204, June 23, 1993] the significant new uses described in paragraph (a)(2) of this section. § 721.1852 Di-alkyl borane (generic). (2) The significant new uses are: (a) Chemical substance and significant (i) Hazard communication program. A new uses subject to reporting. (1) The significant new use of this substance is chemical substance identified generi- any manner or method of manufacture, cally as di-alkyl borane (PMN P-00– import, or processing associated with 1087) is subject to reporting under this any use of this substance without pro- section for the significant new use de- viding risk notification as follows. (A) scribed in paragraph (a)(2) of this sec- If, as a result of the test data required tion.

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(2) The significant new uses are: (v) Release to water. Requirements as (i) Release to water. Requirements as specified in § 721.90 (a)(3), (b)(3), and specified in § 721.90 (a)(4), (b)(4), and (c)(3). (c)(4) (N=200 ppb). (b) Specific requirements. The provi- (ii) [Reserved] sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. The following rec- paragraph. ordkeeping requirements are applicable to manufacturers, importers, and proc- (1) Recordkeeping. Recordkeeping re- essors of this substance, as specified in quirements as specified in § 721.125 (a), § 721.125 (a) through (k). (b), (c), (i) and (k) are applicable to (2) Limitations or revocation of certain manufacturers, importers, and proc- notification requirements. The provisions essors of this substance. of § 721.185 apply to this significant new (2) Limitations or revocation of certain use rule. notification requirements. The provisions (3) Determining whether a specific use is of § 721.185 apply to this section. subject to this section. The provisions of [68 FR 15081, Mar. 28, 2003] § 721.1725(b)(1) apply to this section. [55 FR 26108, June 26, 1990. Redesignated and § 721.1875 Boric acid, alkyl and sub- amended at 58 FR 29946, May 24, 1993; 58 FR stituted alkyl esters (generic name). 34204, June 23, 1993] (a) Chemical substance and significant § 721.1878 Alkali metal alkyl boro- new uses subject to reporting. (1) The hydride (generic). chemical substance boric acid, alkyl (a) and substituted alkyl esters (PMN P- Chemical substance and significant new uses subject to reporting. (1) The 86–1252) is subject to reporting under chemical substance identified generi- this section for the significant new cally as alkali metal alkyl borohydride uses described in paragraph (a)(2) of (PMN P-00–1089) is subject to reporting this section. under this section for the significant (2) The significant new uses are: new use described in paragraph (a)(2) of (i) Protection in the workplace. Re- this section. quirements as specified in § 721.63 (a)(1) (2) The significant new uses are: and (a)(3), (b) [concentration set at 0.1 (i) Release to water. Requirements as percent], and (c). specified in § 721.90 (a)(1), (b)(1), and (ii) Hazard communication program. (c)(1). Requirements as specified in § 721.72 (d), (ii) [Reserved] (e) [concentration set at 0.1 percent], (b) Specific requirements. The provi- (f), and (g)(1)(i), (g)(1)(iv), (g)(1)(vii), sions of subpart A of this part apply to (g)(1)(viii), and (g)(1)(ix), (g)(2)(i) and this section except as modified by this (g)(2)(v), (g)(4)(i) and (g)(4)(iii), and paragraph. (g)(5). The provisions of § 721.72(d) re- (1) Recordkeeping. Recordkeeping requiring employees to be provided with quirements as specified in § 721.125 (a), information on the location and avail- (b), (c), and (k) are applicable to manu- ability of a written hazard communica- facturers, importers, and processors of tion program and MSDSs do not apply this substance. when the written program and MSDS (2) Limitations or revocation of certain are not required under § 721.72 (a) and notification requirements. The provisions (c), respectively. The provision of of § 721.185 apply to this section. § 721.72(g) requiring placement of spe- [68 FR 15082, Mar. 28, 2003] cific information on a MSDS does not apply when a MSDS was not required § 721.1880 Borate(1-), tris(acetato- under § 721.72(c). .kappa.O)hydro-, sodium, (T-4)-. (iii) Industrial, commercial, and con- (a) Chemical substance and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80(k). chemical substance identified as bo- (iv) Disposal. Requirements as speci- rate(1-), tris(acetato-.kappa.O)hydro-, fied in § 721.85 (a)(1) and (b)(1). sodium, (T-4)- (PMN P-00–0922; CAS No.

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56553–60–7) is subject to reporting under (2) Limitations or revocation of certain this section for the significant new use notification requirements. The provisions described in paragraph (a)(2) of this of § 721.185 apply to this section. section. [56 FR 25990, June 5, 1991. Redesignated at 58 (2) The significant new uses are: FR 29946, May 24, 1993, as amended at 58 FR (i) Release to water. Requirements as 34204, June 23, 1993] specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=300 ppb). § 721.1907 Butanamide, 2,2′- ′ ′ ′ (ii) [Reserved] [3 dichloro[1,1 -biphenyl]-4,4 - (b) Specific requirements. The provi- diyl)bisazobis N-2,3-dihydro-2-oxo- 1H-benximdazol-5-yl)-3-oxo-. sions of subpart A of this part apply to this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping. Recordkeeping re- chemical substance generically identi- ′ ′ ′ quirements as specified in § 721.125 (a), fied as butanamide, 2,2 -[3 dichloro[1,1 - ′ (b), (c), and (k) are applicable to manu- biphenyl]-4,4 -diyl)bisazobis N-2,3- facturers, importers, and processors of dihydro-2-oxo-1H-benximdazol-5-yl)-3- oxo- (PMN P-93–1111) is subject to re- this substance. porting under this section for the sig- (2) Limitations or revocation of certain nificant new uses described in para- notification requirements. The provisions graph (a)(2) of this section. of § 721.185 apply to this section. (2) The significant new uses are: [68 FR 15082, Mar. 28, 2003] (i) Hazard communication program. Re- quirements as specified in § 721.72 (a), § 721.1900 Substituted (b), (c), (d), (e) (concentration set at 0.1 bromothiophene. percent), (f), (g)(3)(i), (g)(3)(ii), (a) Chemical substances and significant (g)(4)(iii), and (g)(5). The following ad- new uses subject to reporting. (1) The ditional statements shall appear on chemical substance identified generi- each label and Material Safety Data cally as substituted bromothiophene Sheet (MSDS) as specified by this para- (P-83–769) is subject to reporting under graph: This substance decomposes in this section for the significant new polymers or sheet metal coatings at ° uses described in paragraph (a)(2) of temperatures greater than 280 C to ′ this section. give 3,3 DCB a suspect human carcinogen. (2) The significant new uses are: (ii) Industrial, commercial, and con- (i) Protection in the workplace. Re- sumer activities. Requirements as speci- quirements as specified in § 721.63 (a)(4), fied in § 721.80(f) and processing or use (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), at temperatures above 280 °C. (a)(5)(v), and (a)(6)(i). (iii) Release to water. Requirements as (ii) Hazard communication program. specified in § 721.90 (b)(1) and (c)(1). Requirements as specified in § 721.72 When the substance is processed or (b)(1)(i)(D) and (g)(2)(iv). The provision used as a colorant for dyeing plastics, of § 721.72(g) requiring placement of this section does not apply. specific information in an MSDS does (b) Specific requirements. The provi- not apply when an MSDS is not re- sions of subpart A of this part apply to quired under § 721.72(c). this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125 (a), paragraph. (b), (c), (f), (g), (h), (i), and (k) are ap- (1) Recordkeeping. The following rec- plicable to manufacturers, importers, ordkeeping requirements are applicable and processors of this substance. to manufacturers, importers, and proc- (2) Limitations or revocation of certain essors of this substance: § 721.125 (a), notification requirements. The provisions (b), (c), (d), (f), and (g). of § 721.185 apply to this section. [63 FR 5742, Feb. 4, 1998]

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§ 721.1920 1,4-Bis(3-hydroxy-4- (b) Specific requirements. The provi- benzoylphenoxy)butane. sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified as 1,4- (1) Recordkeeping. The following rec- bis(3-hydroxy-4-benzoylphenoxy)butane ordkeeping requirements are applicable (PMN P-93–483) is subject to reporting to manufacturers, importers, and proc- under this section for the significant essors of this substance, and specified new uses described in paragraph (a)(2) in § 721.125 (a) through (i). of this section. (2) Limitations or revocation of certain (2) The significant new uses are: notification requirements. The provisions (i) Release to water. Requirements as of § 721.185 apply to this significant new specified in § 721.90 (a)(4), (b)(4), and use rule. (c)(4) (where N = 1 ppb). (ii) [Reserved] [56 FR 19242, Apr. 25, 1991. Redesignated and (b) Specific requirements. The provi- amended at 58 FR 29946, 29947, May 24, 1993; 58 sions of subpart A of this part apply to FR 34204, June 23, 1993; 67 FR 12885, Mar. 20, this section except as modified by this 2002] paragraph. § 721.1930 Butanoic acid, antimony (1) Recordkeeping. Recordkeeping re- (3=) salt. quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (a) Chemical substance and significant facturers, importers, and processors of new uses subject to reporting. (1) The this substance. chemical substance identified as buta- (2) Limitations or revocation of certain noic acid, antimony (3=) salt (PMN P- notification requirements. The provisions 94–1143; CAS No. 53856–17–0) is subject of § 721.185 apply to this section. to reporting under this section for the [58 FR 51683, Oct. 4, 1993] significant new uses described in paragraph (a)(2) of this section. § 721.1925 Substituted (2) The significant new uses are: carboheterocyclic butane (i) Protection in the workplace. Re- tetracarboxylate (generic). quirements as specified in § 721.63 (a)(1), (a) Chemical substance and significant (a)(2)(i), (a)(3), (b) (concentration set at new uses subject to reporting. (1) The 0.1 percent), and (c). chemical substance identified generi- (ii) Hazard communication program. cally as substituted carboheterocyclic Requirements as specified in § 721.72 (a), butane tetracarboxylate (PMNs P-90– (b), (c), (d), (e) (concentration set at 0.1 440 and P-95–4) is subject to reporting percent), (g)(1)(i), (g)(1)(vi), (g)(1)(vii), under this section for the significant (g)(1)(ix), (g)(2)(i), (g)(2)(v), and (g)(5). new uses described in paragraph (a)(2) The label and MSDS as required by this of this section. The requirements of paragraph shall also include the fol- this section do not apply when particle lowing statement: This substance may sizes of the chemical substance is cause neurologic effects. This sub- greater than 250 microns. stance may cause cardiovascular ef- (2) The significant new uses are: fects. This substance may cause ocular (i) Protection in the workplace. Re- quirements as specified in § 721.63 (a)(1), irritation. (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (iii) Industrial, commercial, and con- (a)(5)(iii), (a)(6)(i), (b) (concentration sumer activities. Requirements as speci- set at 1.0 percent), and (c). fied in § 721.80(p) (675,000 kg). (ii) Hazard communication program. (b) Specific requirements. The provi- Requirements as specified in § 721.72 (a), sions of subpart A of this part apply to (b), (c), (d), (e) (concentration set at 1.0 this section except as modified by this percent), (f), (g)(1)(i), (g)(1)(iv), paragraph. (g)(1)(vi), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (1) Recordkeeping. Recordkeeping re- (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5). quirements as specified in § 721.125 (a), (iii) Industrial, commercial, and con- (b), (c), (d), (e), (f), (g), (h), and (i) are sumer activities. Requirements as speci- applicable to manufacturers, import- fied in § 721.80(f). ers, and processors of this substance.

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(2) Limitations or revocation of certain § 721.2025 Substituted phenylimino notification requirements. The provisions carbamate derivative. of § 721.185 apply to this section. (a) Chemical substance and significant [63 FR 3423, Jan. 22, 1998] new uses subject to reporting. (1) The chemical substance identified generi- § 721.1950 2-Butenedioic acid (Z), cally as a substituted phenylimino car- mono(2-((1-oxopropenyloxy)ethyl) bamate derivative (PMN P-91–487) is ester . subject to reporting under this section (a) Chemical substances and significant for the significant new uses described new uses subject to reporting. (1) The in paragraph (a)(2) of this section. chemical substance identified as 2- (2) The significant new uses are: butenedioic acid (Z), mono(2-((1- (i) Release to water. Requirements as oxopropenyloxy)ethyl) ester (PMN P- specified in § 721.90(a)(1). 85–543) is subject to reporting under (ii) [Reserved] this section for the significant new (b) Specific requirements. The provi- uses described in paragraph (a)(2) of sions of subpart A of this part apply to this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Protection in the workplace. Re- (1) Recordkeeping requirements. Re- quirements as specified in § 721.63 (a)(1), quirements as specified in § 721.125 (a), (a)(3), (a)(4), (a)(5)(xi), (a)(6)(i), (b), (c), and (k) are applicable to manu- (a)(6)(ii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), facturers, importers, and processors of (b) (concentration set at 0.1 percent), this substance. and (c). (2) Limitations or revocation of certain (ii) Hazard communication program. notification requirements. The provisions Requirements as specified in § 721.72 of § 721.185 apply to this section. (b)(2), (c), (d), (e) (concentration set at 0.1 percent), (f) (g)(1)(iii), (g)(1)(vii), [57 FR 46464, Oct. 8, 1992, as amended at 58 FR (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), 34204, June 23, 1993] (g)(2)(v) and (g)(5). The provision of § 721.2060 Disubstituted § 721.72(d) requiring that employees to benzenedicarboxylic acid (generic). be provided with information on the location and availability of a written (a) Chemical substance and significant hazard communication program does new uses subject to reporting. (1) The not apply when the written program is chemical substance identified generi- not required under § 721.72(a). cally as a disubstituted (iii) Industrial, commercial, and con- benzenedicarboxylic acid (PMN P-01–77) sumer activities. Requirements as speci- is subject to reporting under this sec- fied in § 721.80(l). tion for the significant new use de- (iv) Disposal. Requirements as speci- scribed in paragraph (a)(2) of this sec- fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), tion. (c)(1), and (c)(2). (2) The significant new uses are: (b) Specific requirements. The provi- (i) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Requirements as speci- this section except as modified by this fied in § 721.80(g). paragraph. (ii) Release to water. Requirements as (1) Recordkeeping requirements. The specified § 721.90(a)(1), (b)(1), and (c)(1). following recordkeeping requirements (b) Specific requirements. The provi- are applicable to manufacturers, im- sions of subpart A of this part apply to porters, and processors of this sub- this section except as modified by this stance: § 721.125 (a) through (j). paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125(a), of § 721.185 apply to this section. (b), (c), (i), and (k) are applicable to manufacturers, importers, and proc- [57 FR 44063, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993] essors of this chemical substance.

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(2) Limitations or revocation of certain (3) Determining whether a specific use is notification requirements. The provisions subject to this section. The provisions of of § 721.185 apply to this section. § 721.1725(b)(1) apply to this section. [68 FR 70175, Dec. 17, 2003] [56 FR 25990, June 5, 1991. Redesignated and amended at 58 FR 29946, May 24, 1993; 58 FR § 721.2075 Carbamodithioic acid, meth- 34204, June 23, 1993] yl-, compound with methanamine § 721.2076 D-Glucuronic acid, polymer (1:1). with 6-deoxy-L-mannose and D-glu- (a) Chemical substance and significant cose, acetate, calcium magnesium new uses subject to reporting. (1) The potassium sodium salt. chemical substance identified generi- (a) Chemical substance and significant cally as carbamodithioic acid, methyl- new uses subject to reporting. (1) The , compound with methanamine (1:1) (P- chemical substance identified as D- 84–1042), is subject to reporting under Glucuronic acid, polymer with 6-deoxy- this section for the significant new L-mannose and D-glucose, acetate, cal- uses described in paragraph (a)(2) of cium magnesium potassium sodium this section. salt (PMN P-00–7; CAS No.125005–87–0) (2) The significant new uses are: is subject to reporting under this section for the significant new use de- (i) Protection in the workplace. Re- scribed in paragraph (a)(2) of this sec- quirements as specified in § 721.63 (a)(1), tion. (a)(3), (b) (concentration set at 0.1 per- (2) The significant new uses are: cent), and (c). (i) Industrial, commercial, and con- (ii) Hazard communication program. sumer activities. Requirements as speci- Requirements as specified in § 721.72 (a), fied in § 721.80(j) (oilfield drilling fluid, (b)(2), (d), (e) (concentration set at 0.1 oilfield spacer fluid, oilfield cementing, percent), (f), (g)(1)(vii), (g)(1)(vi), and cementitious packaged products, con- (g)(2)(i). The provision of § 721.72(d) re- crete applications, and foam applica- quiring that employees be provided tions). with information on the location and (ii) [Reserved] availability of MSDSs does not apply (b) Specific requirements. The provi- when an MSDS is not required under sions of subpart A of this part apply to § 721.72(c). The provision of § 721.72(g) this section except as modified by this requiring placement of specific infor- paragraph. mation in an MSDS does not apply (1) Recordkeeping. Recordkeeping re- when an MSDS is not required under quirements as specified in § 721.125(a), § 721.72(c). (b), (c), and (i) are applicable to manufacturers, importers, and processors of (iii) Industrial, commercial, and con- this chemical substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 720.80(k). notification requirements. The provisions (iv) Disposal. Requirements as speci- of § 721.185 apply to this section. fied in § 721.85 (a)(2), (b)(2), and (c)(2). (b) Specific requirements. The provi- [68 FR 70175, Dec. 17, 2003] sions of subpart A of this part apply to § 721.2077 Substituted carbazate (ge- this section except as modified by this neric). paragraph. (a) Chemical substance and significant (1) Recordkeeping. The following rec- new uses subject to reporting. (1) The ordkeeping requirements are applicable chemical substance identified generi- to manufacturers, importers, and proc- cally as a substituted carbazate (PMN essors of this substance, as specified in P-97–267) is subject to reporting under § 721.125 (a) through (g), (i), and (j). this section for the significant new (2) Limitations or revocation of certain uses described in paragraph (a)(2) of notification requirements. The provisions this section. of § 721.185 apply to this significant new (2) The significant new uses are: use rule. (i) Hazard communication program. Re- quirements as specified in § 721.72 (c)(1) and (c)(2)(iv). The MSDS required by

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this paragraph shall include the fol- this section except as modified by this lowing statements: Overexposure to paragraph. this material may cause severe acute (1) Recordkeeping. Recordkeeping re- toxicity including death. This concern quirements as specified in § 721.125 (a), is particularly true with respect to di- (b), (c), (d), (f), (g), (h), and (i) are appli- rect contact to the eyes. Exposure to cable to manufacturers, importers, and the eyes may cause severe acute tox- processors of this substance. icity including death. (2) Limitations or revocation of certain (ii) Industrial, commercial, and con- notification requirements. The provisions sumer activities. Requirements as speci- of § 721.185 apply to this section. fied in § 721.80 (a), (b), (c), and (j). (3) Determining whether a specific use is (b) Specific requirements. The provi- subject to this section. The provisions of sions of subpart A of this part apply to § 721.1725(b)(1) apply to this section. this section except as modified by this paragraph. [63 FR 44576, Aug. 20, 1998] (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), § 721.2079 Dichloro, hydroxy, (b), (c), (h), and (i) are applicable to hydrazino-carbomonocycle (ge- manufacturers, importers, and proc- neric). essors of this substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance generically identi- of § 721.185 apply to this section. fied as dichloro, hydroxy, hydrazino- (3) Determining whether a specific use is carbomonocycle (PMN P-96–757) is sub- subject to this section. The provisions of ject to reporting under this section for § 721.1725(b)(1) apply to this section. the significant new uses described in paragraph (a)(2) of this section. [63 FR 65710, Nov. 30, 1998] (2) The significant new uses are: § 721.2078 1-Piperidinecarboxylic acid, (i) Protection in the workplace. Re- 2-[(dichloro-hydroxy- quirements as specified in § 721.63 (a)(4), carbomonocycle)hydrazono]-, meth- (a)(5)(i), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) yl ester (generic). (concentration set at 0.1 percent), and (a) Chemical substance and significant (c). new uses subject to reporting. (1) The (ii) Hazard communication program. chemical substance generically identi- Requirements as specified in § 721.72 (a), fied as 1-piperidinecarboxylic acid, 2- (b), (c), (d), (e) (concentration set at 0.1 [(dichloro-hydroxy-carbomonocycle) percent), (f), (g)(1)(iv), (g)(1)(vii), hydrazono]-, methyl ester (PMN P-96– (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5). 756) is subject to reporting under this (iii) Industrial, commercial, and con- section for the significant new uses de- sumer activities. Requirements as speci- scribed in paragraph (a)(2) of this sec- fied in § 721.80 (g), (l), and (q). tion. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 (a)(4), paragraph. (a)(5)(i), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (1) Recordkeeping. Recordkeeping re- (concentration set at 0.1 percent), and quirements as specified in § 721.125 (a), (c). (b), (c), (d), (f), (g), (h), and (i) are appli- (ii) Hazard communication program. cable to manufacturers, importers, and Requirements as specified in § 721.72 (a), processors of this substance. (b), (c), (d), (e) (concentration set at 0.1 (2) Limitations or revocation of certain percent), (f), (g)(1)(iv), (g)(1)(vii), notification requirements. The provisions (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5). of § 721.185 apply to this section. (iii) Industrial, commercial, and con- (3) Determining whether a specific use is sumer activities. Requirements as speci- subject to this section. The provisions of fied in § 721.80 (g), (l), and (q). § 721.1725(b)(1) apply to this section. (b) Specific requirements. The provisions of subpart A of this part apply to [63 FR 44576, Aug. 20, 1998]

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§ 721.2081 Dichloro, hydroxy, (a)(5)(ii), (a)(5)(iv), (a)(5)(v), and hydrazino-carbomonocycle- (a)(6)(1). monohydrochloride (generic). (ii) [Reserved] (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance generically identi- this section except as modified by this fied as dichloro, hydroxy, hydrazino- paragraph. carbomonocycle-monohydrochloride (1) Recordkeeping. The recordkeeping (PMN P-96–758) is subject to reporting requirements specified in § 721.125 (a), under this section for the significant (b), (c), and (d) are applicable to manu- new uses described in paragraph (a)(2) facturers, importers, and processors of of this section. this substance. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Protection in the workplace. Re- notification requirements. The provisions quirements as specified in § 721.63 (a)(4), of § 721.185 apply to this section. (a)(5)(i), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) [63 FR 44576, Aug. 20, 1998] (concentration set at 0.1 percent), and (c). § 721.2084 Carbon oxyfluoride (Car- (ii) Hazard communication program. bonic difluoride). Requirements as specified in § 721.72 (a), (a) Chemical substance and significant (b), (c), (d), (e) (concentration set at 0.1 new use subject to reporting. (1) The percent), (f), (g)(1)(iv), (g)(1)(vii), chemical substance carbon oxyfluoride (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5). (CAS No. 353–50–4), also referred to as (iii) Industrial, commercial, and con- carbonic difluoride, is subject to re- sumer activities. Requirements as speci- porting under this section for the sig- fied in § 721.80 (g), (l), and (q). nificant new use described in paragraph (b) Specific requirements. The provi- (a)(2) of this section. sions of subpart A of this part apply to (2) The significant new use is: Manu- this section except as modified by this facture, import, or processing of 10,000 paragraph. pounds or more per year per facility for (1) Recordkeeping. Recordkeeping re- any use. quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), (d), (f), (g), (h), and (i) are appli- sions of subpart A of this part apply to cable to manufacturers, importers, and this section except as modified by this processors of this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. The following rec- notification requirements. The provisions ordkeeping requirements are applicable of § 721.185 apply to this section. to manufacturers, importers, and proc- (3) Determining whether a specific use is essors of this substance, as specified in subject to this section. The provisions of § 721.125 (a), (b), and (c). § 721.1725(b)(1) apply to this section. (2) [Reserved] [63 FR 44576, Aug. 20, 1998] [58 FR 63516, Dec. 1, 1993]

§ 721.2083 Polysubstituted § 721.2085 Hydroxyalkylquinoline carbomonocyclic hydroxylamine dioxoindandialkylcarboxamide. (generic). (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified generically as a hydroxyalkylquinoline cally as a polysubstituted dioxoindandialkylcarboxamide (PMN carbomonocyclic hydroxylamine (PMN P-94–682) is subject to reporting under P-97–878) is subject to reporting under this section for the significant new this section for the significant new uses described in paragraph (a)(2) of uses described in paragraph (a)(2) of this section. this section. (2) The significant new uses are: (2) The significant new uses are: (i) Release to water. Requirements as (i) Protection in the workplace. Re- specified in § 721.90 (a)(1), (b)(1), and quirements as specified in § 721.63 (a)(4), (c)(1).

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(ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping requirements. Rec- (1) Recordkeeping. Recordkeeping re- ordkeeping requirements specified in quirements as specified in § 721.125 (a), § 721.125 (a), (b), (c), and (k) are applica- (b), (c), and (i) are applicable to manu- ble to manufacturers, importers, and facturers, importers, and processors of processors of this substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [60 FR 11042, Mar. 1, 1995] [65 FR 368, Jan. 5, 2000]

§ 721.2086 Coco acid triamine conden- § 721.2088 Carboxylic acids, (C6–C9) sate, polycarboxylic acid salts. branched and linear. (a) Chemical substance and significant (a) Chemical substances and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified as coco chemical substances identified generi- acid triamine condensate, polycarbox- cally as carboxylic acids, (C6–C9) ylic acid salts. (PMN P-92–446) is sub- branched and linear (PMNs P-93–313, ject to reporting under this section for 314, 315, and 316) are subject to report- the significant new uses described in ing under this section for the signifi- paragraph (a)(2) of this section. cant new uses described in paragraph (2) The significant new uses are: (a)(2) of this section. (i) Requirements as Release to water. (2) The significant new uses are: specified in § 721.90(a)(1), (b)(1), and (i) Hazard communication program. Re- (c)(1). quirements as specified in § 721.72 (a), (ii) [Reserved] (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (b) Specific requirements. The provi- (g)(4)(iii) and (g)(5). sions of subpart A of this part apply to this section except as modified by this (ii) Release to water. Requirements as paragraph. specified in § 721.90 (a)(4), (b)(4), and (1) Recordkeeping requirements. Re- (c)(4) (where N = 300 ppb for P-93–313, quirements as specified in § 721.125 (a), 314, and 315 and N = 50 ppb for P-93–316). (b), (c), and (i) are applicable to manu- (b) Specific requirements. The provi- facturers, importers, and processors of sions of subpart A of this part apply to this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping requirements. Rec- of § 721.185 apply to this section. ordkeeping requirements specified in § 721.125 (a), (b), (c), (f), (g), (h), and (k) [57 FR 46464, Oct. 8, 1992, as amended at 58 FR are applicable to manufacturers, im- 34204, June 23, 1993] porters, and processors of this sub- § 721.2087 3-furancarboxaldehyde, stance. tetrahydro-. (2) Limitations or revocation of certain notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The chemical substance identified as a 3- [60 FR 11042, Mar. 1, 1995] furancarboxaldehyde, tetrahydro- (PMN P-98–1048; CAS No. 79710–86–4) is § 721.2089 Tetrasubstituted subject to reporting under this section aminocarboxylic acid. for the significant new use described in (a) Chemical substance and significant paragraph (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified generi- (i) Industrial, commercial, and con- cally as a tetrasubstituted sumer activities. Requirements as speci- aminocarboxylic acid (PMN P-85–619) is fied in § 721.80(g). subject to reporting under this section

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for the significant new uses described tion for the significant new use de- in paragraph (a)(2) of this section. scribed in paragraph (a)(2) of this sec- (2) The significant new uses are: tion. (i) Hazard communication program. Re- (2) The significant new use is: Manu- quirements as specified in § 721.72 (a), facture, import, or processing of 10,000 (b), (c), (d), (f), (g)(1)(vii), (g)(2)(iii), pounds or more per year per facility for (g)(3)(ii), (g)(4)(ii), (g)(4)(iii), and (g)(5). any use. (ii) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(1), (b)(1), and sions of subpart A of this part apply to (c)(1). this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. The following rec- this section except as modified by this ordkeeping requirements are applicable paragraph. to manufacturers, importers, and proc- (1) Recordkeeping. Recordkeeping re- essors of this substance, as specified in quirements as specified in § 721.125 (a) § 721.125 (a), (b), and (c). through (h) and (k) are applicable to (2) [Reserved] manufacturers, importers, and proc- [58 FR 63516, Dec. 1, 1993] essors of this substance. (2) Limitations or revocation of certain § 721.2093 Alkenyl carboxylate, metal notification requirements. The provisions salt (generic). of § 721.185 apply to this section. (a) Chemical substance and significant [60 FR 45081, Aug. 30, 1995] new uses subject to reporting. (1) The chemical substance identified generi- § 721.2091 Chloroalkane. cally as alkenyl carboxylate, metal (a) Chemical substance and significant salt (PMN P-99–0848) is subject to renew uses subject to reporting. (1) The porting under this section for the sig- chemical substance identified generi- nificant new use described in paragraph cally as a chloroalkane (PMN P-96–273) (a)(2) of this section. is subject to reporting under this sec- (2) The significant new uses are: tion for the significant new uses de- (i) Industrial, commercial, and con- Requirements as speci- scribed in paragraph (a)(2) of this sec- sumer activities. fied in § 721.80(j) (an emulsifier for met- tion. alworking fluids) and (q). (2) The significant new uses are: (ii) [Reserved] (i) Industrial, commercial, and con- (b) Specific requirements. The provi- sumer activities. Requirements as speci- sions of subpart A of this part apply to fied in § 721.80(g). this section except as modified by this (ii) [Reserved] paragraph. (b) The provi- Specific requirements. (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), and (i) are applicable to manu- paragraph. facturers, importers, and processors of (1) Recordkeeping. Recordkeeping re- this substance. quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), and (i) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this substance. (3) Determining whether a specific use is (2) Limitations or revocation of certain subject to this section. The provisions of notification requirements. The provisions § 721.1725(b)(1) apply to this section. of § 721.185 apply to this section. [68 FR 15082, Mar. 28, 2003] [63 FR 3423, Jan. 22, 1998] § 721.2094 N,N′-di(alkyl § 721.2092 3-Methylcholanthrene. heteromonocycle)amino (a) Chemical substance and significant chlorotriazine. new use subject to reporting. (1) The (a) Chemical substance and significant chemical substance 3- new uses subject to reporting. (1) The methylcholanthrene (CAS No. 56–49–5) chemical substance identified generi- is subject to reporting under this sec- cally as N,N′-di(alkyl

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heteromonocycle)amino chlorotriazine trisodium (PMN P-95–1242) is subject to (PMN P-93–1369) is subject to reporting reporting under this section for the sig- under this section for the significant nificant new uses described in para- new uses described in paragraph (a)(2) graph (a)(2) of this section. of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial, and con- (i) Protection in the workplace. Re- sumer activities. Requirements as speci- quirements as specified in § 721.63 (a)(4), fied in § 721.80 (f), (v)(1), (w)(1), and (a)(5)(i) (this respirator meets the min- (y)(1). imum requirement for persons exposed (ii) [Reserved] via inhalation during manufacture), (b) Specific requirements. The provi- (a)(5)(ii), (a)(5)(iv), (a)(5)(v) (these three sions of subpart A of this part apply to respirators meet the minimum require- this section except as modified by this ments for persons exposed via inhala- paragraph. tion during processing and use), (1) Recordkeeping. Recordkeeping re- (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), quirements as specified in § 721.125 (a), (b) (concentration set at 0.1 percent), (b), (c), and (i) are applicable to manu- and (c). facturers, importers, and processors of (ii) Hazard communication program. this substance. Requirements as specified in § 721.72(a), (2) Limitations or revocation of certain (b), (c), (d), (e) (concentration set at 0.1 notification requirements. The provisions percent), (f), (g)(1)(iv), (g)(1)(vii), of § 721.185 apply to this section. (g)(1)(viii), (g)(1)(ix), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(3)(i), (g)(3)(ii), [61 FR 63736, Dec. 2, 1996] (g)(4)(iii), and (g)(5). § 721.2097 Azo chromium complex dye- (iii) Industrial, commercial, and con- stuff preparation (generic name). sumer activities. Requirements as specified in § 721.80(q). (a) Chemical substance and significant (iv) Release to water. Requirements as new uses subject to reporting. (1) The specified in § 721.90 (a)(1), (b)(1), and chemical substance identified generi- (c)(1). cally as an azo chromium complex dye- (b) Specific requirements. The provi- stuff preparation (PMN P-95–240) is sub- sions of subpart A of this part apply to ject to reporting under this section for this section except as modified by this the significant new uses described in paragraph. paragraph (a)(2) of this section. (1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a), (i) Industrial, commercial and consumer (b), (c), (d), (f), (g), (h), (i), and (k) are activities. Requirements as specified in applicable to manufacturers, import- § 721.80 (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), ers, and processors of this substance. and (x)(2). (2) Limitations or revocation of certain (ii) [Reserved] notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to (3) Determining whether a specific use is this section except as modified by this subject to this section. The provisions of paragraph. § 721.1725(b)(1) apply to this section. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), [63 FR 3424, Jan. 22, 1998] (b), (c), and (i) are applicable to manufacturers, importers, and processors of § 721.2095 Chromate(3-), bis 2-[[sub- this substance. stituted-3-[(5-sulfo-1- naphthalenyl)azo] (2) Limitations or revocation of certain phenyl]azo]substituted monocycle, notification requirements. The provisions trisodium (generic name). of § 721.185 apply to this section. (a) Chemical substance and significant [61 FR 63736, Dec. 2, 1996] new uses subject to reporting. (1) The chemical substance identified generi- § 721.2098 Aliphatic polycarboxylic cally as chromate(3-), bis 2-[[sub- acid metal salt (generic). stituted-3-[(5-sulfo-1-naphthalenyl) (a) Chemical substance and significant azo]phenyl]azo]substituted monocycle, new uses subject to reporting. (1) The

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chemical substance identified generically as Thiosubstituted carbonate cally as an aliphatic polycarboxylic ester (PMN P-99–0654) is subject to re- acid metal salt (PMN P-01–7) is subject porting under this section for the sig- to reporting under this section for the nificant new use described in paragraph significant new use described in para- (a)(2) of this section. graph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Release to water. Requirements as (i) Industrial, commercial, and con- specified in § 721.90 (a)(1), (b)(1), and sumer activities. Requirements as speci- (c)(1). fied in § 721.80(v)(1), (x)(1), and (f). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manu- (b), (c), and (i) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. this chemical substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [65 FR 81399, Dec. 26, 2000]

[68 FR 70176, Dec. 17, 2003] § 721.2122 Substituted phenyl azo substituted sulfo carbopolycycle. § 721.2120 Cyclic amide. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified as a cy- cally as a substituted phenyl azo sub- clic amide (PMN P-92–131) is subject to stituted sulfo carbopolycycle (PMN P- reporting under this section for the sig- 96–702) is subject to reporting under nificant new uses described in para- this section for the significant new graph (a)(2) of this section. uses described in paragraph (a)(2) of (2) The significant new uses are: this section. (i) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(4), (b)(4), and (i) Industrial, commercial, and con- (c)(4) (concentration set at 70 ppb). sumer activities. Requirements as speci- (ii) [Reserved] fied in § 721.80(r) (204,000 kg) (activated (b) Specific requirements. The provi- sludge adsorption isotherm- OPPTS sions of subpart A of this part apply to 835.1110 test guideline (public draft; 61 this section except as modified by this FR 16486, April 15, 1996) (FRL–5363–1), paragraph. daphnid acute toxicity-§ 797.1300, fish (1) Recordkeeping requirements. Re- acute toxicity-§ 797.1400, murine im- quirements as specified in § 721.125 (a), mune allergic response study (b), (c), and (i) are applicable to manu- (Toxicology and Applied Pharmacology facturers, importers, and processors of 112:190–197 (1992)). A person may not this substance. manufacture or import the substance (2) Limitations or revocation of certain beyond the following aggregate produc- notification requirements. The provisions tion volume limits, unless that person of § 721.185 apply to this section. conducts the following corresponding [57 FR 46465, Oct. 8, 1992, as amended at 58 FR studies on the substance and submits 34204, June 23, 1993] all final reports and underlying data in accordance with the procedures and § 721.2121 Thiosubstituted carbonate criteria specified in paragraphs ester (generic). (a)(2)(i)(A), (a)(2)(i)(B), (a)(2)(i)(C), and (a) Chemical substance and significant (a)(2)(i)(D) of this section. new uses subject to reporting. (1) The (A) Each study required to be per- chemical substance identified generi- formed pursuant to this section must

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be scientifically valid. Scientifically compliance with either of the following valid means that the study was con- paragraph (a)(2)(i)(D)(2)(i) or ducted according to: (a)(2)(i)(D)(2)(ii) of this section. (1) The test guidelines specified in (i) The person may reconduct the paragraph (a)(2)(i) of this section. study. If there is sufficient time to re- (2) An EPA-approved protocol. conduct the study and submit the re- (3) TSCA Good Laboratory Practice port and data to EPA at least 14 weeks Standards at 40 CFR part 792. before exceeding the production limit (4) Using methodologies generally ac- as required by paragraph (a)(2)(i)(C)(3) cepted at the time the study is initi- of this section, the person shall comply ated. with paragraph (a)(2)(i)(C)(3) of this (5) Any deviation from these require- section. If there is insufficient time for ments must be approved in writing by EPA. the person to comply with paragraph (B) Before starting to conduct any of (a)(2)(i)(C)(3) of this section, the person the studies in paragraph (a)(2)(i) of this may exceed the production limit and section, the person must obtain ap- shall submit the report and data in proval of test protocols from EPA by triplicate to EPA within a reasonable submitting written protocols. EPA will period of time, all as specified by EPA respond to the person within 4 weeks of in the notice described in paragraph receiving the written protocols. Pub- (a)(2)(i)(D)(1) of this section. EPA will lished test guidelines specified in para- respond to the person in writing, with- graph (a)(2)(i) of this section (e.g., 40 in 6 weeks of receiving the person’s re- CFR part 797 or part 798) provide gen- port and data. eral guidance for development of test (ii) The person may, within 4 weeks protocols, but are not themselves ac- of receiving from EPA the notice de- ceptable protocols. scribed in paragraph (a)(2)(i)(D)(1) of (C) The person shall: this section, submit to EPA a written (1) Conduct each study in good faith report refuting EPA’s finding. EPA will with due care. respond to the person in writing, with- (2) Promptly furnish to EPA the rein 4 weeks of receiving the person’s results of any interim phase of each port. study. (E) The person is not required to con- (3) Submit, in triplicate (with an adduct a study specified in paragraph ditional sanitized copy, if confidential business information is involved), the (a)(2)(i) of this section if notified in final report of each study and all un- writing by EPA that it is unnecessary derlying data (‘‘the report and data’’) to conduct that study. to EPA no later than 14 weeks prior to (ii) [Reserved] exceeding the applicable production (b) Specific requirements. The provi- volume limit. The final report shall sions of subpart A of this part apply to contain the contents specified in 40 this section except as modified by this CFR 792.185. paragraph. (D)(1) Except as described in para- (1) Recordkeeping. Recordkeeping re- graph (a)(2)(i)(D)(2) of this section, if, quirements as specified in § 721.125 (a), within 6 weeks of EPA’s receipt of a (b), (c), and (i) are applicable to manu- test report and data, the person re- facturers, importers, and processors of ceives written notice that EPA finds this substance. that the data generated by a study are (2) Limitations or revocation of certain scientifically invalid, the person is pro- notification requirements. The provisions hibited from further manufacture and of § 721.185 apply to this section. import of the PMN substance beyond the applicable production volume [63 FR 3424, Jan. 22, 1998] limit. (2) The person may continue to man- § 721.2140 Carbopolycyclicol azoalkyl- ufacture and import the PMN sub- aminoalkylcarbomonocyclic ester, stance beyond the applicable produc- halogen acid salt. tion limit only if so notified, in writ- (a) Chemical substance and significant ing, by EPA in response to the person’s new uses subject to reporting. (1) The

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chemical substance generically identi- facturers, importers, and processors of fied as carbopolycyclicol azoalkyla- this substance. minoalkylcarbomonocyclic ester, halo- (2) Limitations or revocation of certain gen acid salt (PMN P-88–1682) is subject notification requirements. The provisions to reporting under this section for the of § 721.185 apply to this section. significant new uses described in paragraph (a)(2) of this section. [63 FR 3425, Jan. 22, 1998] (2) The significant new uses are: § 721.2155 Alkoxyamino-alkyl-cou- (i) Hazard communication program. Re- marin (generic). quirements as specified in § 721.72 (a), (b)(2), (c), (d), (f), (g)(3)(ii), (g)(4)(i), and (a) Chemical substance and significant (g)(5). new uses subject to reporting. (1) The (ii) Industrial, commercial, and con- chemical substance identified generi- sumer activities. Requirements as speci- cally as alkoxyamino-alkyl-coumarin. fied in § 721.80(q). (PMN P-00–0108) is subject to reporting under this section for the significant (iii) Release to water. Requirements as new use described in paragraph (a)(2) of specified in § 721.90 (a)(4), (b)(4) and this section. (c)(4) (where N = 1 ppb). (2) The significant new uses are: (b) Specific requirements. The provisions of subpart A of this part apply to (i) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80(f). (1) Recordkeeping requirements. Re- (ii) [Reserved] quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), (f), (g), (h), and (i) are applica- sions of subpart A of this part apply to ble to manufacturers, importers, and this section except as modified by this processors of this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (i) are applicable to manu- (3) Determining whether a specific use is facturers, importers, and processors of subject to this section. The provisions of this substance. § 721.1725(b)(1) apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [57 FR 44063, Sept. 23, 1992, as amended at 58 of § 721.185 apply to this section. FR 29946, May 24, 1993; 58 FR 34204, June 23, 1993] [68 FR 15082, Mar. 28, 2003]

§ 721.2145 Ceteareth-25 sorbate. § 721.2175 Salt of cyclodiamine and (a) Chemical substance and significant mineral acid. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as ceteareth-25 sorbate (PMN P- chemical substance identified generi- 96–941) is subject to reporting under cally as a salt of cyclodiamine and this section for the significant new mineral acid (PMN P-91–838) is subject uses described in paragraph (a)(2) of to reporting under this section for the this section. significant new uses described in para- (2) The significant new uses are: graph (a)(2) of this section. (i) Industrial, commercial, and con- (2) The significant new uses are: sumer activities. Requirements as speci- (i) Industrial, commercial, and con- fied in § 721.80(g). sumer activities. Requirements as speci- (ii) [Reserved] fied in § 721.80(f). (b) Specific requirements. The provi- (ii) [Reserved] sion of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping requirements. Re- (b), (c), and (i) are applicable to manu- quirements as specified in § 721.125 (a),

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(b), (c), and (i) are applicable to manu- (ii) Industrial, commercial, and con- facturers, importers, and processors of sumer activities. Requirements as speci- this substance. fied in § 721.80(l). (2) Limitations or revocation of certain (iii) Release to water. Requirements as notification requirements. The provisions specified in § 721.90 (a)(1), (b)(1), and of § 721.185 apply to this section. (c)(1). [57 FR 46465, Oct. 8, 1992, as amended at 58 FR (b) Specific requirements. The provi- 34204, June 23, 1993] sions of subpart A of this part apply to this section except as modified by this § 721.2222 Cyclohexanamine, N,N-di- paragraph. methyl-, compd. with alpha- isotridecyl-omega-hydroxypoly(oxy- (1) Recordkeeping requirements. Re- 1,2-ethanediyl) phosphate. quirements as specified in § 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are ap- (a) Chemical substance and significant new uses subject to reporting. (1) The plicable to manufacturers, importers, chemical substance identified as and processors of this substance. cyclohexanamine, N,N-dimethyl-, (2) Limitations or revocation of certain compd. with alpha-isotridecyl-omega- notification requirements. The provisions hydroxypoly(oxy-1,2-ethanediyl) phos- of § 721.185 apply to this section. phate (PMN P-96–1176; CAS No. 164383– [57 FR 44064, Sept. 23, 1992, as amended at 58 18–0) is subject to reporting under this FR 34204, June 23, 1993] section for the significant new uses described in paragraph (a)(2) of this sec- § 721.2260 1,2-Cyclohexanedicarboxylic tion. acid, 2,2-bis[[[[2-[(oxiranylmethoxy) (2) The significant new uses are: carbonyl]cyclohexy]carbonyl] (i) Industrial, commercial and consumer oxy]methyl]-1,3-propanediyl activities. Requirements as specified in bis(oxiranylmethyl) ester. § 721.80(j). (a) Chemical substance and significant (ii) [Reserved] new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substance 1,2- sions of subpart A of this part apply to cyclohexanedicarboxylic acid, 2,2- this section except as modified by this bis[[[[2-[(oxiranylmethoxy) carbonyl] paragraph. cyclohexy]carbonyl] oxy]methyl]-1,3- (1) Recordkeeping. Recordkeeping re- propanediyl bis(oxiranylmethyl) ester quirements as specified in § 721.125 (a), (PMN P-92–471) is subject to reporting (b), (c), and (i) are applicable to manu- under this section for the significant facturers, importers, and processors of new uses described in paragraph (a)(2) this substance. (2) Limitations or revocation of certain of this section. notification requirements. The provisions (2) The significant new uses are: (i) of § 721.185 apply to this section. Protection in the workplace. Require- ments as specified in § 721.63 (a)(4), [63 FR 3425, Jan. 22, 1998] (a)(5)(ii), (a)(5)(viii), (a)(5)(ix), (a)(6)(ii), (b) (concentration set at 0.1 percent), § 721.2250 1,4-Cyclohexanediamine, cis- and trans-. and (c). (ii) Hazard communication program. (a) Chemical substances and significant Requirements as specified in § 721.72 (a), new uses subject to reporting. (1) The (b), (c), (d), (e) (concentration set at 0.1 chemical substances identified as 1,4- percent), (f), (g)(1)(vi), (g)(1)(vii), cyclohexanediamine, cis- and trans- (PMNs P-87–1881 and P-87–1882; CAS (g)(2)(ii), (g)(2)(iv), and (g)(5). numbers 15827–56–2 and 2615–25–0) are (iii) Industrial, commercial, and con- subject to reporting under this section sumer activities. Requirements as for the significant new uses described specified in § 721.80(q). in paragraph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Hazard communication program. Re- this section except as modified by this quirements as specified in § 721.72 (a), paragraph. (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), (1) Recordkeeping. Recordkeeping re- (g)(5). quirements as specified in § 721.125 (a),

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(b), (c), (f), (g), (h), and (i) are applica- (b) Specific requirements. The provi- ble to manufacturers, importers, and sions of subpart A of this part apply to processors of this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), (3) Determining whether a specific use is (b), (c), and (k) are applicable to manu- subject to this section. The provisions of facturers, importers, and processors of § 721.1725(b)(1) apply to this section. this substance. (2) Limitations or revocation of certain [58 FR 51702, Oct. 4, 1993] notification requirements. The provisions of § 721.185 apply to this section. § 721.2265 Polyalkylene oxide dialkylamine (generic). [58 FR 51683, Oct. 4, 1993] (a) Chemical substance and significant ′ ′ new uses subject to reporting. (1) The § 721.2275 N,N,N ,N -Tetrakis(oxiranylmethyl)-1,3-cyclohexane dimeth- chemical substance identified generi- anamine. cally as Polyalkylene oxide dialkylamine (PMN P-99–0423) is sub- (a) Chemical substances and significant ject to reporting under this section for new uses subject to reporting. (1) The chemical substance identified as the significant new use described in ′ ′ paragraph (a)(2) of this section. N,N,N ,N -tetrakis(oxiranylmethyl)-1,3- cyclohexanedimethanamine (P-84–7) is (2) The significant new uses are: subject to reporting under this section (i) Industrial, commercial, and con- for the significant new uses described sumer activities. Requirements as speci- in paragraph (a)(2) of this section. fied in § 721.80(j). (2) The significant new uses are: (ii) [Reserved] (i) Protection in the workplace. Re- (b) Specific requirements. The provi- quirements as specified in § 721.63 (a)(1), sions of subpart A of this part apply to (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), this section except as modified by this (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), paragraph. (a)(6)(ii), (b) (concentration set at 0.1 (1) Recordkeeping. Recordkeeping re- percent), and (c). quirements as specified in § 721.125 (a), (ii) Hazard communication program. (b), (c), and (i) are applicable to manu- Requirements as specified in § 721.72 (a), facturers, importers, and processors of (b)(2), (c), (d), (e) (concentration set at this substance. 0.1 percent), (f), (g)(1)(vii), (g)(1)(viii), (2) Limitations or revocation of certain (g)(2)(i), (g)(2)(ii), (g)(2)(iv), and notification requirements. The provisions (g)(2)(v). of § 721.185 apply to this section. (b) Specific requirements. The provi- (3) Determining whether a specific use is sions of subpart A of this part apply to subject to this section. The provisions of this section except as modified by this § 721.1725(b)(1) apply to this section. paragraph. [65 FR 81399, Dec. 26, 2000] (1) Recordkeeping. The following recordkeeping requirements are applicable § 721.2270 Aliphatic dicarboxylic acid to manufacturers, importers, and proc- salt. essors of this substance: § 721.125 (a) (a) Chemical substance and significant through (h). new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified generi- notification requirements. The provisions cally as aliphatic dicarboxylic acid salt of § 721.185 apply to this section. (PMN P-92–1352) is subject to reporting [56 FR 25991, June 5, 1991. Redesignated at 58 under this section for the significant FR 29947, May 24, 1993, as amended at 58 FR new uses described in paragraph (a)(2) 34204, June 23, 1993] of this section. (2) The significant new uses are: § 721.2280 (i) Release to water. Requirements as Cyclopropanecarboxaldehyde. specified in § 721.90 (a)(4), (b)(4), and (a) Chemical substance and significant (c)(4) (where N = 1,000 ppb). new uses subject to reporting. (1) The (ii) [Reserved] chemical substance identified as

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cyclopropanecarboxaldehyde (PMN P- § 721.2287 DDT 96–33) is subject to reporting under this (Dichlorodiphenyltrichloroethane). section for the significant new uses de- (a) Chemical substance and significant scribed in paragraph (a)(2) of this sec- new use subject to reporting. (1) The tion. chemical substance DDT (2) The significant new uses are: (dichlorodiphenyltrichloroethane) (i) Protection in the workplace. Re- (CAS No. 50–29–3) is subject to report- quirements as specified in § 721.63 (a)(4), ing under this section for the signifi- (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(xii), cant new use described in paragraph (a)(5)(xiii), (a)(5)(xiv), (a)(6)(v), (b) (con- (a)(2) of this section. centration set at 1.0 percent), and (c). (2) The significant new use is: Manu- Each person who is reasonsonably like- facture, import, or processing of 10,000 ly to be exposed by inhalation to the pounds or more per year per facility for PMN substance in vapor form during any use. loading of rail cars is provided with, (b) Specific requirements. The provi- and is required to wear, at a minimum, sions of subpart A of this part apply to a National Institute for Occupational this section except as modified by this Safety and Health (NIOSH) approved paragraph. category 19C Type C supplied-air res- (1) Recordkeeping. The following rec- pirator operated in pressure demand or ordkeeping requirements are applicable other positive pressure mode and to manufacturers, importers, and proc- equipped with a full facepiece with an essors of this substance, as specified in assigned protection factor (APF) of 200. § 721.125 (a), (b), and (c). As an alternative to the respiratory re- (2) [Reserved] quirements in this section, manufac- [58 FR 63516, Dec. 1, 1993] turers, importers, and processors may use the new chemical exposure limits § 721.2340 Dialkenylamide (generic provisions, including sampling and an- name). alytical methods which have pre- (a) Chemical substance and significant viously been approved by EPA for this new uses subject to reporting. (1) The substance, found in the TSCA section chemical substance identified generi- 5(e) consent order for this substance. cally as a dialkenylamide (P-87–502) is (ii) Hazard communication program. subject to reporting under this section Requirements as specified in § 721.72 (a), for the significant new uses described (b), (c), (d), (e) (concentration set at 1.0 in paragraph (a)(2) of this section. percent), (f), (g)(1)(i), (g)(1)(ii), (2) The significant new uses are: (g)(1)(iv), (g)(1)(ix), (g)(2)(ii), (g)(2)(iii), (i) Protection in the workplace. Re- (g)(2)(iv), and (g)(5). quirements as specified in § 721.63 (a)(1), (iii) Industrial, commercial, and con- (a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), sumer activites. Requirements as speci- (a)(5)(xiii), (a)(5)(xiv), (a)(5)(xv), fied in § 721.80(q). (a)(6)(v), (b) (concentration set at 0.1 (b) Specific requirements. The provi- percent), and (c). sions of subpart A of this part apply to (ii) Hazard communication program. this section except as modified by this Requirements as specified in § 721.72 (a), paragraph. (b)(2), (c), (d), (e) (concentration set at (1) Recordkeeping. Recordkeeping re- 0.1 percent), (f), (g)(1)(vi), (g)(1)(vii), quirements as specified in § 721.125 (a), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (b), (c), (d), (e), (f), (g), (h), and (i) are (g)(2)(v), and (g)(5). applicable to manufacturers, import- (iii) Industrial, commercial, and con- ers, and processors of this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80 (g) and (q). notification requirements. The provisions (iv) Disposal. Requirements as speci- of § 721.185 apply to this section. fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2) and (c)(1), (c)(2). (3) Determining whether a specific use is (b) Specific requirements. The provi- subject to this section. The provisions of sions of subpart A of this part apply to § 721.1725(b)(1) apply to this section. this section except as modified by this [63 FR 3425, Jan. 22, 1998] paragraph.

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(1) Recordkeeping. The following rec- (i) Release to water. Requirements as ordkeeping requirements are applicable specified in § 721.90 (a)(1), (b)(1), and to manufacturers, importers, and proc- (c)(1). essors of this substance, as specified in (ii) [Reserved] § 721.125 (a) through (j). (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this significant new paragraph. use rule. (1) Recordkeeping. Recordkeeping re- (3) Determining whether a specific use is quirements as specified in § 721.125 (a), subject to this section. The provisions of (b), (c), and (k) are applicable to manu- § 721.1725(b)(1) apply to this section. facturers, importers, and processors of these substances. [55 FR 26099, June 26, 1990. Redesignated and (2) Limitations or revocation of certain amended at 58 FR 29946, May 24, 1993; 58 FR notification requirements. The provisions 34204, June 23, 1993] of § 721.185 apply to this section. § 721.2345 Alkyletherpropyl [63 FR 3425, Jan. 22, 1998] dialkylamines. (a) Chemical substance and significant § 721.2355 Diethylstilbestrol. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substances identified as new use subject to reporting. (1) The alkyletherpropyl dialkylamines (PMNs chemical substance diethylstilbestrol P-96–1510/1511/1512/1513/1514) are subject (CAS No. 56–53–1) is subject to report- to reporting under this section for the ing under this section for the signifi- significant new uses described in para- cant new use described in paragraph graph (a)(2) of this section. (a)(2) of this section. (2) The significant new uses are: (2) The significant new use is: Manu- (i) Release to water. Requirements as facture, import, or processing of 10,000 specified in § 721.90 (a)(1), (b)(1), and pounds or more per year per facility for (c)(1). any use. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. The following rec- paragraph. ordkeeping requirements are applicable (1) Recordkeeping. Recordkeeping re- to manufacturers, importers, and proc- quirements as specified in § 721.125 (a), essors of this substance, as specified in (b), (c), and (k) are applicable to manu- § 721.125 (a), (b), and (c). facturers, importers, and processors of (2) [Reserved] these substances. (2) Limitations or revocation of certain [58 FR 63516, Dec. 1, 1993] notification requirements. The provisions of § 721.185 apply to this section. § 721.2380 Disubstituted diamino anisole. [63 FR 3425, Jan. 22, 1998] (a) Chemical substance and significant new uses subject to reporting. (1) The fol- § 721.2350 Alkyltri, tetra, and lowing chemical substance referred to pentaamines. by its premanufacture notice number (a) Chemical substance and significant and generic chemical name is subject new uses subject to reporting. (1) The to reporting under this section for the chemical substances identified generi- significant new uses described in para- cally as alkyltri, tetra, and graph (a)(2) of this section: P-83–822, pentaamines (PMNs P-96–406/407/408) disubstituted diamino anisole. are subject to reporting under this sec- (2) The significant new uses are: tion for the significant new uses de- (i) Use other than as an intermediate. scribed in paragraph (a)(2) of this sec- (ii) Manufacture, import, or proc- tion. essing for use as an intermediate with- (2) The significant new uses are: out establishing a program whereby:

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(A) Persons employed by or under the this section except as modified by this control of the manufacturer, importer, paragraph. or processor who may be exposed to the (1) Recordkeeping. Recordkeeping re- substance (including those persons in- quirements as specified in § 721.125 (a), volved in maintenance, packaging, and (b), (c), and (k) are applicable to manu- storage operations) wear protective facturers, importers, and processors of gloves determined to be impervious to this substance. the substance by testing the gloves (2) Limitations or revocation of certain under the conditions of exposure or by notification requirements. The provisions evaluating the specifications provided of § 721.185 apply to this section. by the manufacturer of the gloves, and [65 FR 368, Jan. 5, 2000] (B) Packages containing the substance (including those storing the sub- § 721.2410 Alkoxylated stance between manufacturing or im- alkyldiethylenetriamine, alkyl sul- porting and processing stages) are la- fate salts. beled to indicate that the substance (a) Chemical substances and significant should be handled only while using new uses subject to reporting. (1) The gloves determined to be impervious to chemical substances identified generi- the substance. cally as alkoxylated (b) Specific requirements. The provi- dialkyldiethylenetriamine, alkyl sul- sions of subpart A of this part apply to fate salts (PMN P-94–325, 326, and 327) this section except as modified by this are subject to reporting under this sec- paragraph. tion for the significant new uses de- (1) Recordkeeping. In addition to the scribed in paragraph (a)(2) of this sec- requirements of § 721.17, manufacturers, tion. importers, and processors of the chem- (2) The significant new uses are: ical substance identified in paragraph (i) Industrial, commercial, and con- (a)(1) of this section must maintain the sumer activities. Requirements as speci- following records for 5 years from their fied in § 721.80(o). creation: (ii) [Reserved] (i) The results of any determination (b) Specific requirements. The provi- that gloves are impervious. sions of subpart A of this part apply to (ii) The names of persons required to this section except as modified by this wear gloves. paragraph. (iii) Copies of labels described in (1) Recordkeeping requirements. Rec- paragraph (a)(2)(ii)(B) of this section. ordkeeping requirements specified in (2) [Reserved] § 721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and [50 FR 34465, Aug. 26, 1985. Redesignated at 53 processors of this substance. FR 2845, Feb. 2, 1988. Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 (2) Limitations or revocation of certain FR 34204, June 23, 1993] notification requirements. The provisions of § 721.185 apply to this section. § 721.2385 Fluoroalkyl diester (ge- [60 FR 11042, Mar. 1, 1995] neric). (a) Chemical substance and significant § 721.2420 Alkoxylated new uses subject to reporting. (1) The dialkyldiethylenetriamine, alkyl chemical substance identified generi- sulfate salt. cally as fluoroalkyl diester (PMNs P- (a) Chemical substance and significant 98–1046 and P-98–1047) is subject to renew uses subject to reporting. (1) The porting under this section for the sig- chemical substance identified generi- nificant new uses described in para- cally as an alkoxylated graph (a)(2) of this section. dialkyldiethylenetriamine, alkyl sul- (2) The significant new uses are: fate salt (PMN P-91–288) is subject to (i) Release to water. Requirements as reporting under this section for the sig- specified in § 721.90 (a)(1), (b)(1), and nificant new uses described in para- (c)(1). graph (a)(2) of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90(a)(1).

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(ii) [Reserved] for the significant new uses described (b) Specific requirements. The provi- in paragraph (a)(2) of this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Protection in the workplace. Re- paragraph. quirements as specified in § 721.63 (a)(1), (1) Recordkeeping requirements. Re- (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5) quirements as specified in § 721.125 (a), (iii), (a)(6)(i), (b) (concentration set at (b), (c), and (k) are applicable to manu- 0.1 percent), and (c). facturers, importers, and processors of (ii) Hazard communication program. this substance. Requirements as specified in § 721.72 (a), (2) Limitations or revocation of certain (b), (c), (d), (e) (concentration set at 0.1 notification requirements. The provisions percent), (f), (g)(1)(iii), (g)(1)(vi), of § 721.185 apply to this section. (g)(1)(vii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), [57 FR 46465, Oct. 8, 1992, as amended at 58 FR (g)(2)(iii), (g)(2)(iv), (g)(2)(v) and (g)(5). 34204, June 23, 1993] (iii) Industrial, commercial, and consumer activities. Requirements as speci- § 721.2465 Xanthylium, 9-(2- fied in § 721.80 (f) and (q). (ethoxycarbonyl)phenyl)-3,6- (b) Specific requirements. The provi- bis(ethylamino)-2,7-dimethyl-, ethyl sulfate. sions of subpart A of this part apply to this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping requirements. Re- chemical substance identified as quirements as specified in § 721.125 (a) xanthylium, 9-(2- through (i) are applicable to manufac- (ethoxycarbonyl)phenyl)-3,6- turers, importers, and processors of bis(ethylamino)-2,7-dimethyl-, ethyl this substance. sulfate (PMN P-00–1195; CAS No. 26694– 69–9) is subject to reporting under this (2) Limitations or revocation of certain section for the significant new use de- notification requirements. The provisions scribed in paragraph (a)(2) of this sec- of § 721.185 apply to this section. tion. (3) Determining whether a specific use is (2) The significant new uses are: subject to this section. The provisions of (i) Industrial, commercial, and con- § 721.1725(b)(1) apply to this section. sumer activities. Requirements as speci- [57 FR 44064, Sept. 23, 1992, as amended at 58 fied in § 721.80(f) and (j) (a basic dye for FR 29946, May 24, 1993; 58 FR 34204, June 23, complex basic dye pigment manufac- 1993] ture). (ii) [Reserved] § 721.2480 Isoalkyldimethylamine (ge- (b) Specific requirements. The provi- neric). sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified generi- (1) Recordkeeping. Recordkeeping re- cally as isoalkyldimethylamine (PMN quirements as specified in § 721.125 (a), P-96–1320) is subject to reporting under (b), (c), and (k) are applicable to manu- this section for the significant new facturers, importers, and processors of uses described in paragraph (a)(2) of this substance. this section. (2) Limitations or revocation of certain (2) The significant new uses are: notification requirements. The provisions (i) Release to water. Requirements as of § 721.185 apply to this section. specified in § 721.90 (a)(4), (b)(4), and [68 FR 15082, Mar. 28, 2003] (c)(4) (N = 3). (ii) [Reserved] § 721.2475 Dimetridazole. (b) Specific requirements. The provi- (a) Chemical substances and significant sions of subpart A of this part apply to new uses subject to reporting. (1) The this section except as modified by this chemical substance identified generi- paragraph. cally as dimetridazole (P-90–1308) is (1) Recordkeeping. Recordkeeping re- subject to reporting under this section quirements as specified in § 721.125 (a),

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(b), (c), and (k) are applicable to manu- tact. When using this substance use facturers, importers, and processors of respiratory protection or engineering this substance. and process controls to mitigate res- (2) Limitations or revocation of certain piratory exposure. When using this notification requirements. The provisions substance use dermal protection to pre- of § 721.185 apply to this section. vent dermal exposure. [63 FR 44577, Aug. 20, 1998] (iii) Industrial, commercial, and consumer activities. Requirements as speci- § 721.2485 1,3-Dioxolane, 2-ethenyl-. fied in § 721.80(j). (a) Chemical substances and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified as 1,3- this section except as modified by this Dioxolane, 2-ethenyl- (PMN P-96–1006; paragraph. CAS No. 3984–22–3) is subject to report- (1) Recordkeeping. Recordkeeping re- ing under this section for the signifi- quirements as specified in § 721.125 (a), cant new uses described in paragraph (b), (c), (d), (e), (f), (g), and (h) are ap- (a)(2) of this section. plicable to manufacturers, importers, (2) The significant new uses are: and processors of this substance. (i) Protection in the workplace. Re- (2) Limitations or revocation of certain quirements as specified in § 721.63 (a)(1), notification requirements. The provisions (a)(2)(i), (a)(2)(ii), (a)(3)(i), (a)(4), of § 721.185 apply to this section. (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), [63 FR 44577, Aug. 20, 1998] (a)(5)(xiv), (a)(6)(v), (b) (concentration set at 1.0 percent), and (c). The imper- § 721.2520 Alkylated diphenyls. viousness of each item pursuant to (a) Chemical substance and significant (a)(2)(i) and (a)(2)(ii) must be dem- new uses subject to reporting. (1) The onstrated by actual testing under chemical substances identified generi- (a)(3)(i) and not by manufacturer speci- cally as alkylated diphenyls (PMN Nos. fications. Permeation testing shall be P-90–237, P-90–248, and P-90–249) are sub- conducted according to the ASTM F739 ject to reporting under this section for ‘‘Standard Test Method for Resistance the significant new uses described in of Protective Clothing Materials to paragraph (a)(2) of this section. Permeation by Liquids or Gases.’’ Re- (2) The significant new uses are: sults shall be recorded as a cumulative (i) Release to water. Requirements as permeation rate as a function of time, specified in § 721.90 (a)(4), (b)(4), and and shall be documented in accordance (c)(4) (where N = 1 ppb). with ASTM F739 using the format spec- (ii) [Reserved] ified in ASTM F1194–89 ‘‘Guide for Doc- (b) Specific requirements. The provi- umenting the Results of Chemical Per- sions of subpart A of this part apply to meation Testing on Protective Cloth- this section except as modified by this ing Materials.’’ Gloves may not be used paragraph. for a time period longer than they are (1) Recordkeeping. Recordkeeping re- actually tested and must be replaced at quirements as specified in § 721.125 (a), the end of each work shift. The manu- (b), (c), and (k) are applicable to manufacturer, importer, or processor must facturers, importers, and processors of submit all test data to the Agency and these substances. must receive written Agency approval (2) Limitations or revocation of certain for each type of glove tested prior to notification requirements. The provisions use of such gloves. of § 721.185 apply to this significant new (ii) Hazard communication program. Requirements as specified in § 721.72 (a), use rule. (b), (c), (d), (e) (concentration set at 1.0 [58 FR 32237, June 8, 1993] percent), (f), (g)(1)(iii), (g)(1)(iv), (g)(2)(ii), (g)(2)(iii), and (g)(5). The fol- § 721.2527 Substituted diphenylazo dye lowing statements shall appear on each (generic name). label as specified in § 721.72(b) and the (a) Chemical substance and significant MSDS as specified in § 721.72(c): This new uses subject to reporting. (1) The substance may cause fatality. When chemical substance identified generi- using this substance avoid dermal con- cally as a substituted diphenylazo dye

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(PMN P-95–514) is subject to reporting homopolymer, Bu alc.-blocked (PMN P- under this section for the significant 95–1386; CAS No. 186321–98–2) is subject new uses described in paragraph (a)(2) to reporting under this section for the of this section. significant new uses described in para- (2) The significant new uses are: graph (a)(2) of this section. (i) Industrial, commercial, and con- (2) The significant new uses are: sumer activities. Requirements as speci- (i) Industrial, commercial, and con- fied in § 721.80(f). sumer activities. Requirements as speci- (ii) [Reserved] fied in § 721.80(y)(1). (b) Specific requirements. The provi- (ii) [Reserved] sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), and (i) are applicable to manu- quirements as specified in § 721.125 (a), facturers, importers, and processors of (b), (c), and (i) are applicable to manu- this substance. facturers, importers, and processors of (2) Limitations or revocation of certain this substance. notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions of § 721.185 apply to this section. [61 FR 63736, Dec. 2, 1996] [63 FR 3425, Jan. 22, 1998] § 721.2532 Substituted diphenylmethane (generic). § 721.2540 Diphenylmethane (a) Chemical substance and significant diisocyanate (MDI) modified. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as a substituted diphenylmethane chemical substance identified generi- (PMN P-97–4) is subject to reporting cally as a diphenylmethane diisocya- under this section for the significant nate (MDI) modified (PMN P-92–294) is new uses described in paragraph (a)(2) subject to reporting under this section of this section. for the significant new uses described (2) The significant new uses are: in paragraph (a)(2) of this section. (i) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(1), (b)(1), and (i) Industrial, commercial, and con- (c)(1). sumer activities. Requirements as speci- (ii) [Reserved] fied in § 721.80 (v)(1), (v)(2), (w)(1), (b) Specific requirements. The provi- (w)(2), (x)(1), (x)(2), (y)(1), and (y)(2). sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125 (a), paragraph. (b), (c), and (k) are applicable to manu- (1) Recordkeeping requirements. Re- facturers, importers, and processors of quirements as specified in § 721.125 (a), this substance. (b), (c), and (i) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [63 FR 44577, Aug. 20, 1998] of § 721.185 apply to this section. § 721.2535 Benzene, 1,1′- [57 FR 46465, Oct. 8, 1992, as amended at 58 FR methylanebis[4-isocyanato-, 34204, June 23, 1993] homopolymer, Bu alc.-blocked. (a) Chemical substance and significant § 721.2560 Alkylated diphenyl oxide new uses subject to reporting. (1) The (generic name). chemical substance identified as ben- (a) Chemical substance and significant zene, 1,1′-methylanebis[4-isocyanato-, new uses subject to reporting. (1) The

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chemical substance alkylated diphenyl alkylated sulfonated diphenyl oxide, oxide (PMN P-84–1079) is subject to re- amine salt (PMN P-93–353) are subject porting under this section for the sig- to reporting under this section for the nificant new uses described in para- significant new uses described in paragraph (a)(2) of this section. graph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Protection in the workplace. Re- (i) Release to water. Requirements as quirements as specified in § 721.63 (a)(1) specified in § 721.90 (a)(4), (b)(4), and and (a)(3), (b) [concentration set at 1.0 (c)(4) (where N = 20 ppb). percent], and (c). (ii) [Reserved] (ii) Hazard communication program. (b) Specific requirements. The provi- Requirements as specified in § 721.72 sions of subpart A of this part apply to (b)(2), (c), (d), (e) [concentration set at this section except as modified by this 1.0 percent], (f), and (g)(1)(vi) and paragraph. (g)(1)(ix), (g)(2)(i) and (g)(2)(v), and (1) Recordkeeping. Recordkeeping re- (g)(5). The provision of § 721.72(d) requirements as specified in § 721.125 (a), quiring that employees be provided (b), (c), and (k) are applicable to manu- with information on the location and facturers, importers, and processors of availability of MSDSs does not apply this substance. when a MSDS was not required under (2) Limitations or revocation of certain § 721.72(c). notification requirements. The provisions (iii) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as specified in § 721.80(g). The term inter- [58 FR 51683, Oct. 4, 1993] mediate as used in § 721.80(g) is defined as an intermediate for making sulfo- § 721.2570 Alkylated diphenyls (genated surfactants. neric). (iv) Release to water. Requirements as (a) Chemical substance and significant specified in § 721.90 (a)(3), (b)(3), and new uses subject to reporting. (1) The (c)(3). chemical substances identified generi- (b) Specific requirements. The provi- cally as alkylated diphenyls (PMNs P- sions of subpart A of this part apply to 97–869/870/871) are subject to reporting this section except as modified by this under this section for the significant paragraph. new uses described in paragraph (a)(2) (1) Recordkeeping. The following rec- of this section. ordkeeping requirements are applicable (2) The significant new uses are: to manufacturers, importers, and proc- (i) Release to water. Requirements as essors of this substance, as specified in specified in § 721.90 (a)(4), (b)(4), and § 721.125 (a) through (k). (c)(4) (N = 1). (2) Limitations or revocation of certain (ii) [Reserved] notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this significant new sions of subpart A of this part apply to use rule. this section except as modified by this (3) Determining whether a specific use is paragraph. subject to this section. The provisions of (1) Recordkeeping. Recordkeeping re- § 721.1725(b)(1) apply to this section. quirements as specified in § 721.125 (a), [55 FR 26109, June 26, 1990, as amended at 57 (b), (c), and (k) are applicable to manu- FR 54305, Nov. 18, 1992. Redesignated and facturers, importers, and processors of amended at 58 FR 29946, May 24, 1993; 58 FR these substances. 34204, June 23, 1993] (2) Limitations or revocation of certain notification requirements. The provisions § 721.2565 Alkylated sulfonated diphenyl oxide, alkali and amine of § 721.185 apply to this section. salts. [63 FR 44577, Aug. 20, 1998] (a) Chemical substances and significant new uses subject to reporting. (1) The § 721.2575 Disubstituted chemical substances identified as diphenylsulfone. alkylated sulfonated diphenyl oxide, (a) Chemical substance and significant alkali salt (PMN P-93–352) and new uses subject to reporting. (1) The

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chemical substance identified generi- (i) Industrial, commercial, and con- cally as disubstituted diphenylsulfone sumer activities. Requirements as speci- (PMN P-92–1119) is subject to reporting fied in § 721.80 (v)(1), (w)(1), (x)(1). under this section for the significant (ii) [Reserved] new uses described in paragraph (a)(2) (b) Specific requirements. The provi- of this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Protection in the workplace. Re- paragraph. quirements as specified in § 721.63(a)(1), (1) Recordkeeping. Recordkeeping re- (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), quirements as specified in § 721.125 (a), (a)(5)(iv), (a)(5)(v), (a)(6)(i), (a)(6)(ii), (b) (b), (c), and (i) are applicable to manu- (concentration set at 0.1 percent), and facturers, importers, and processors of (c). this substance. (ii) Hazard communication program. (2) Limitations or revocation of certain Requirements as specified in § 721.72 (a), notification requirements. The provisions (b), (c), (d), (f), (g)(1)(vi), (g)(1)(vii), of § 721.185 apply to this section. (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), [68 FR 15082, Mar. 28, 2003] (g)(4)(iii), and (g)(5). The following additional statements shall appear on § 721.2580 C.I. Disperse Red 152 (ge- each label and MSDS as required by neric). this paragraph: This substance may (a) Chemical substance and significant cause blood effects. new uses subject to reporting. (1) The (iii) Industrial, commercial, and con- chemical substance identified generi- sumer activities. Requirements as speci- cally as C.I. disperse red 152 (PMN P- fied in § 721.80 (f), (o), and (q). 97–820) is subject to reporting under (iv) Release to water. Requirements as this section for the significant new specified in § 721.90 (b)(1) and (c)(1). uses described in paragraph (a)(2) of (b) Specific requirements. The provi- this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Industrial, commercial, and con- paragraph. sumer activities. Requirements as speci- (1) Recordkeeping. Recordkeeping re- fied in § 721.80 (v)(1), (w)(1), and (x)(1). quirements as specified in § 721.125 (a) (ii) [Reserved] through (k) are applicable to manufac- (b) Specific requirements. The provi- turers, importers, and processors of sions of subpart A of this part apply to this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements specified in § 721.125 (a), (b), (3) Determining whether a specific use is (c), and (i) are applicable to manufac- subject to this section. The provisions of turers, importers, and processors of § 721.1725(b)(1) apply to this section. this substance. (2) Limitations or revocation of certain [58 FR 51683, Oct. 4, 1993] notification requirements. The provisions § 721.2577 Copper complex of (sub- of § 721.185 apply to this section. stituted sulfonaphthyl azo sub- [63 FR 44577, Aug. 20, 1998] stituted phenyl) disulfonaphthyl azo, amine salt (generic). § 721.2582 Reaction product of alkyl- (a) Chemical substance and significant ene diamine, MDl, substituted new uses subject to reporting. (1) The carbomonocyclic amine and chemical substances identified generi- alkylamine (generic). cally as copper complex of (substituted (a) Chemical substance and significant sulfonaphthyl azo substituted phenyl) new uses subject to reporting. (1) The disulfonaphthyl azo, amine salt (PMNs chemical substance identified generi- P-00–0364 and P-00–0365) are subject to cally as reaction product of alkylene reporting under this section for the sig- diamine, MDl, substituted nificant new use described in paragraph carbomonocyclic amine and (a)(2) of this section. alkylamine (PMN P-98–1262) is subject (2) The significant new uses are: to reporting under this section for the

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significant new use described in para- specified in paragraphs (a)(2)(iii)(A), graph (a)(2) of this section. (a)(2)(iii)(B), (a)(2)(iii)(C), and (2) The significant new uses are: (a)(2)(iii)(D) of this section. (i) Release to water. Requirements as (A) Each study required to be per- specified in § 721.90 (a)(1), (b)(1), and formed pursuant to this section must (c)(1). be scientifically valid. Scientifically (ii) [Reserved] valid means that the study was con- (b) Specific requirements. The provi- ducted according to: sions of subpart A of this part apply to (1) The test guidelines specified in this section except as modified by this paragraph (a)(2)(iii) of this section. paragraph. (2) An EPA-approved protocol. (1) Recordkeeping. Recordkeeping re- (3) TSCA Good Laboratory Practice quirements as specified in § 721.125 (a), Standards at 40 CFR part 792. (b), (c), and (k) are applicable to manu- (4) Using methodologies generally ac- facturers, importers, and processors of cepted at the time the study is initi- this substance. ated. (2) Limitations or revocation of certain (5) Any deviation from these require- notification requirements. The provisions ments must be approved in writing by of § 721.185 apply to this section. EPA. [68 FR 15083, Mar. 28, 2003] (B) Before starting to conduct any of the studies in paragraph (a)(2)(iii) of § 721.2584 Dodecanoic acid, 12-amino-. this section, the person must obtain (a) Chemical substance and significant approval of test protocols from EPA by new uses subject to reporting. (1) The submitting written protocols. EPA will chemical substance identified as dodec- respond to the person within 4 weeks of anoic acid, 12-amino- (PMN P-98–0823; receiving the written protocols. Pub- CAS No. 693–57–2) is subject to report- lished test guidelines specified in para- ing under this section for the signifi- graph (a)(2)(iii) of this section (e.g., 40 cant new uses described in paragraph CFR part 797 or part 798) provide gen- (a)(2) of this section. eral guidance for development of test (2) The significant new uses are: protocols, but are not themselves ac- (i) Protection in the workplace. Re- ceptable protocols. quirements as specified in § 721.63 (a)(4), (C) The person shall: (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (1) Conduct each study in good faith (a)(5)(vii), (a)(6)(i), (b) (concentration with due care. set at 0.1 percent), and (g). As an alter- (2) Promptly furnish to EPA the re- native to the respiratory requirements sults of any interim phase of each listed here, a manufacturer, importer, study. or processor may choose to follow the (3) Submit, in triplicate (with an ad- NCEL provision listed in the 5(e) conditional sanitized copy, if confidential sent order for this substance. The business information is involved), the NCEL is 1.0 mg/m3 as an 8-hour time- final report of each study and all un- weighted average verified by actual derlying data (‘‘the report and data’’) monitoring data. to EPA no later than 14 weeks prior to (ii) Hazard communication program. exceeding the applicable production Requirements as specified in § 721.72 (a), volume limit. The final report shall (b), (c), (d), (e), (f), (g)(1)(ii), (g)(1)(vii), contain the contents specified in 40 (g)(2)(ii), and (g)(2)(iv). CFR 792.185. (iii) Industrial, commercial, and con- (D)(1) Except as described in para- sumer activities. Requirements as speci- graph (a)(2)(iii)(D)(2) of this section, if, fied in § 721.80 (g), (r) (6,000,000 kg.), and within 6 weeks of EPA’s receipt of a a carcinogenicity study (OPPTS test report and data, the person re- 870.4200). A person may not manufac- ceives written notice that EPA finds ture or import the substance beyond that the data generated by a study are the aggregate production volume limit, scientifically invalid, the person is pro- unless that person conducts this study hibited from further manufacture and on the substance and submits all final import of the PMN substance beyond reports and underlying data in accord- the applicable production volume ance with the procedures and criteria limit.

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(2) The person may continue to man- chemical substances identified generi- ufacture and import the PMN sub- cally as sodium salts of dodecylphenol stance beyond the applicable produc- (PMNs P-97–1060/1061/1062) are subject tion limit only if so notified, in writ- to reporting under this section for the ing, by EPA in response to the person’s significant new uses described in para- compliance with either of the following graph (a)(2) of this section. paragraphs (a)(2)(iii)(D)(2)(i) or (2) The significant new uses are: (a)(2)(iii)(D)(2)(ii) of this section. (i) Release to water. Requirements as (i) The person may reconduct the specified in § 721.90 (a)(4), (b)(4), and study. If there is sufficient time to re- (c)(4) (N = 1). conduct the study and submit the re- (ii) [Reserved] port and data to EPA at least 14 weeks (b) Specific requirements. The provi- before exceeding the production limit sions of subpart A of this part apply to as required by paragraph (a)(2)(iii)(C)(3) this section except as modified by this of this section, the person shall comply paragraph. with paragraph (a)(2)(iii)(C)(3) of this (1) Recordkeeping. Recordkeeping re- section. If there is insufficient time for quirements as specified in § 721.125 (a), the person to comply with paragraph (b), (c), and (k) are applicable to manu- (a)(2)(iii)(C)(3) of this section, the per- facturers, importers, and processors of son may exceed the production limit these substances. and shall submit the report and data in (2) Limitations or revocation of certain triplicate to EPA within a reasonable notification requirements. The provisions period of time, all as specified by EPA of § 721.185 apply to this section. in the notice described in paragraph [63 FR 44577, Aug. 20, 1998] (a)(2)(iii)(D)(1) of this section. EPA will respond to the person in writing, with- § 721.2600 Epibromohydrin. in 6 weeks of receiving the person’s re- (a) Chemical substance and significant port and data. new use subject to reporting. (1) The (ii) The person may, within 4 weeks chemical substance epibromohydrin, of receiving from EPA the notice de- CAS Number 3132-64-7, [Listed in TSCA scribed in paragraph (a)(2)(iii)(D)(1) of Inventory as oxirane,(bromoethyl)-] is this section, submit to EPA a written subject to reporting under this section report refuting EPA’s finding. EPA will for the significant new use described in respond to the person in writing, with- paragraph (a)(2) of this section. in 4 weeks of receiving the person’s re- (2) The significant new use is any port. use. (E) The person is not required to con- (b) Special requirements. The provi- duct a study specified in paragraph sions of subpart A of this part apply to (a)(2)(iii) of this section if notified in this section except as modified by this writing by EPA that it is unnecessary paragraph. to conduct that study. (1) Persons who must report. Section (b) Specific requirements. The provi- 721.5 applies to this section except for sions of subpart A of this part apply to § 721.5(a)(2). A person who intends to this section except as modified by this manufacture, import, or process for paragraph. commercial purposes the substance (1) Recordkeeping. Recordkeeping re- identified in paragraph (a)(1) of this quirements as specified in § 721.125 (a), section and intends to distribute the (b), (c), (d), and (i) are applicable to substance in commerce must submit a manufacturers, importers, and proc- significant new use notice. essors of this substance. (2) [Reserved] (2) Limitations or revocation of certain notification requirements. The provisions [52 FR 41300, Oct. 27, 1987. Redesignated at 53 of § 721.185 apply to this section. FR 2845, Feb. 2, 1988. Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 [68 FR 15083, Mar. 28, 2003] FR 34204, June 23, 1993]

§ 721.2585 Sodium salts of § 721.2625 Reaction product of alkane- dodecylphenol (generic). diol and epichlorohydrin. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The

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chemical substance identified generically as aromatic epoxide resin (PMN cally as reaction product of alkanediol P-99–1399) is subject to reporting under and epichlorohydrin (PMN P-89–760) is this section for the significant new use subject to reporting under this section described in paragraph (a)(2) of this for the significant new uses described section. in paragraph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial, and con- (i) Protection in the workplace. Re- sumer activities. Requirements as speci- quirements as specified in § 721.63 (a)(1), fied in § 721.80(y)(1). (a)(3), (a)(4), (a)(5)(viii), (a)(5)(ix), (ii) [Reserved] (a)(6)(ii), (a)(6)(v), (b) (concentration (b) Specific requirements. The provi- set at 0.1 percent), and (c). sions of subpart A of this part apply to (ii) Hazard communication program. this section except as modified by this Requirements as specified in § 721.72 (a), paragraph. (b), (c), (d), (e) (concentration set at 0.1 (1) Recordkeeping. Recordkeeping re- percent), (f), and (g)(1)(vi), (g)(1)(vii), quirements as specified in § 721.125 (a), (g)(2)(i) through (g)(2)(v), (g)(3)(ii), (b), (c), and (i) are applicable to manu- (g)(4)(i), and (g)(5). facturers, importers, and processors of (iii) Industrial, commercial, and con- this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80 (l), and (q). (The produc- notification requirements. The provisions tion limit applies to the aggregate proof § 721.185 apply to this section. duction volume of both P-89–750 and P- [68 FR 15083, Mar. 28, 2003] 89–760. Results from testing this substance can be used to evaluate the tox- § 721.2675 Perfluoroalkyl epoxide (ge- icity P-89–750 as well.) neric name). (iv) Disposal. Requirements as speci- (a) Chemical substances and significant fied in § 721.85 (b)(1), (b)(2), (c)(1), and new uses subject to reporting. (1) The (c)(2). chemical substance identified generi- (v) Release to water. Requirements as cally as perfluoroalkyl epoxide (PMN specified in § 721.90 (a)(2)(ii) (Oil and P-86–562) is subject to reporting under grease separation may be used as an al- this section for the significant new ternative treatment.), (b)(1), and (c)(1). uses described in paragraph (a)(2) of (b) Specific requirements. The provi- this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Protection in the workplace. Re- paragraph. quirements as specified in § 721.63 (a)(1), (1) Recordkeeping. The following rec- (a)(3), (b) (concentration set at 0.1 per- ordkeeping requirements are applicable cent), and (c). to manufacturers, importers, and proc- (ii) Hazard communication program. essors of this substance, as specified in Requirements as specified in § 721.72 (a), § 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (b)(2), (d), (e) (concentration set at 0.1 (i), (j), and (k). percent), (f), (g)(1)(vi), (g)(1)(vii), (2) Limitations or revocation of certain (g)(2)(i) and (g)(2)(v). The provision of notification requirements. The provisions § 721.72(d) requiring that employees be of § 721.185 apply to this significant new provided with information on the loca- use rule. tion and availability of MSDSs does (3) Determining whether a specific use is not apply when an MSDS is not re- subject to this section. The provisions of quired under § 721.72(c). The provision § 721.1725(b)(1) apply to this section. of § 721.72(g) requiring placement of [55 FR 46772, Nov. 6, 1990. Redesignated and specific information on an MSDS does amended at 58 FR 29946, May 24, 1993; 58 FR not apply when an MSDS is not re- 34204, June 23, 1993] quired under § 721.72(c). (iii) Industrial, commercial, and con- § 721.2673 Aromatic epoxide resin (ge- sumer activities. Requirements as speci- neric). fied in § 721.80 (g) and (q). (a) Chemical substance and significant (iv) Disposal. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), chemical substance identified generi- (c)(1), and (c)(2).

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(v) Release to water. § 721.90 (a)(3), [Listed in TSCA Inventory as oxirane, (b)(3), and (c)(3). (2,2,2-trichloroethyl)-] is subject to re- (b) Specific requirements. The provi- porting under this section for the sig- sions of subpart A of this part apply to nificant new use described in paragraph this section except as modified by this (a)(2) of this section. paragraph. (2) The significant new use is any (1) Recordkeeping. The following rec- use. ordkeeping requirements are applicable (b) Special requirements. The provi- to manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance, as specified in this section except as modified by this § 721.125 (a) through (g), (i), (j), and (k). paragraph. (2) Determining whether a specific use is (1) Persons who must report. Section subject to this section. The provisions of 721.5 applies to this section except for § 721.1725(b)(1) apply to this section. (3) Limitations or revocation of certain § 721.5(a)(2). A person who intends to notification requirements. The provisions manufacture, import, or process for of § 721.185 apply to this significant new commercial purposes the substance use rule. identified in paragraph (a)(1) of this section and intends to distribute the [55 FR 26099, June 26, 1990. Redesignated and substance in commerce must submit a amended at 58 FR 29946, May 24, 1993; 58 FR significant new use notice. 34204, June 23, 1993] (2) [Reserved] § 721.2685 Polyisobutene epoxide (ge- [52 FR 41300, Oct. 27, 1987. Redesignated at 53 neric). FR 2845, Feb. 2, 1988. Further redesignated at (a) Chemical substances and significant 58 FR 29946, May 24, 1993, as amended at 58 new uses subject to reporting. (1) The FR 34204, June 23, 1993] chemical substances identified generically as polyisobutene epoxide (PMNs § 721.2752 Epoxy resin containing P-99–951 and P-99–952) are subject to re- phosphorus (generic). porting under this section for the sig- (a) Chemical substance and significant nificant new uses described in para- new uses subject to reporting. (1) The graph (a)(2) of this section. chemical substance identified generi- (2) The significant new uses are: cally as an epoxy resin containing (i) Industrial, commercial, and con- phosphorus (PMN P-00–912) is subject sumer activities. Requirements as speci- to reporting under this section for the fied in § 721.80(j). significant new use described in para- (ii) [Reserved] graph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80(j). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] quirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manu- (b) Specific requirements. The provi- facturers, importers, and processors of sions of subpart A of this part apply to this chemical substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125(a), (3) Determining whether a specific use is (b), (c), and (i) are applicable to manu- subject to this section. The provisions of facturers, importers, and processors of § 721.1725(b)(1) apply to this section. this chemical substance. (2) Limitations or revocation of certain [68 FR 70176, Dec. 17, 2003] notification requirements. The provisions § 721.2725 Trichlorobutylene oxide. of § 721.185 apply to this section. (3) Determining whether a specific use is (a) Chemical substance and significant subject to this section. The provisions of new use subject to reporting. (1) The § 721.575(b)(1) apply to this section. chemical substance trichlorobutylene oxide (TCBO), CAS Number 3083–25–8, [68 FR 70176, Dec. 17, 2003]

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§ 721.2755 Cycloaliphatic epoxy resin new use described in paragraph (a)(2) of (generic). this section. (a) Chemical substance and significant (2) The significant new use is: Any new uses subject to reporting. (1) The use. chemical substance identified generi- (b) Specific requirements. The provi- cally as cycloaliphatic epoxy resin sions of subpart A of this part apply to (PMN P-98–105) is subject to reporting this section except as modified by the under this section for the significant following paragraphs: new uses described in paragraph (a)(2) (1) Persons who must report. Section of this section. 721.5 applies to this section except for (2) The significant new uses are: § 721.5(a)(2). A person who intends to (i) Protection in the workplace. Re- manufacture, import, or process for quirements as specified in § 721.63 (a)(1), commercial purposes the substance (a)(2)(i), (a)(3), (a)(4), (a)(5)(iii), identified in paragraph (a)(1) of this (a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(6)(ii), section and intends to distribute the (b) (concentration set at 0.1 percent), substance in commerce must submit a and (c). As an alternative to the res- significant new use notice. piratory requirements listed here, a manufacturer, importer, or processor (2) Exemptions. Section 721.45 applies may choose to follow the NCEL provi- to this section except for § 721.45(f). A sions listed in the TSCA section 5(e) person who intends to import or proc- consent order for this substance. The ess the substance identified in para- NCEL is 0.3 mg/m3. graph (a)(1) of this section as part of an (ii) Hazard communication program. article is subject to the notification Requirements as specified in § 721.72 (a), provisions of § 721.25. (b), (c), (d), (e) (concentration set 0.1 [56 FR 56472, Nov. 5, 1991. Redesignated at 58 percent), (f), (g)(1)(vi), (g)(1)(vii), FR 29946, May 24, 1993, as amended at 58 FR (g)(2)(i), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), 34204, June 23, 1993] and (g)(5). (iii) Industrial, commercial, and con- § 721.2805 Acrylate ester. sumer activities. Requirements as speci- (a) Chemical substance and significant fied in § 721.80(q). new uses subject to reporting. (1) The (b) Specific requirements. The provisions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as an acrylate ester (PMN P-96– paragraph. 824) is subject to reporting under this (1) Recordkeeping. Recordkeeping re- section for the significant new uses de- quirements as specified in § 721.125 (a), scribed in paragraph (a)(2) of this sec- (b), (c), (d), (e), (f), (g), (h), and (i) are tion. applicable to manufacturers, import- (2) The significant new uses are: ers, and processors of this substance. (i) Release to water. Requirements as (2) Limitations or revocation of certain specified in § 721.90 (a)(1), (b)(1), and notification requirements. The provisions (c)(1). of § 721.185 apply to this section. (ii) [Reserved] (3) Determining whether a specific use is (b) Specific requirements. The provi- subject to this section. The provisions of sions of subpart A of this part apply to § 721.1725(b)(1) apply to this section. this section except as modified by this [65 FR 368, Jan. 5, 2000] paragraph. (1) Recordkeeping. Recordkeeping re- § 721.2800 Erionite fiber. quirements as specified in § 721.125 (a), (a) Chemical substance and significant (b), (c), and (k) are applicable to manu- new use subject to reporting. (1) The facturers, importers, and processors of chemical substance, erionite fiber (CAS this substance. No. 66733–21–9 (when an exact molec- (2) Limitations or revocation of certain ular formula is known) and 12510–42–8 notification requirements. The provisions (when an exact molecular formula is of § 721.185 apply to this section. not known)), is subject to reporting under this section for the significant [63 FR 3426, Jan. 22, 1998]

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§ 721.2825 Alkyl ester (generic name). chemical substance substituted amino- (a) Chemical substance and significant benzoic acid ester (PMN P-84–951) is new uses subject to reporting. (1) The subject to reporting under this section chemical substance alkyl ester (PMN for the significant new uses described P-84–968) is subject to reporting under in paragraph (a)(2) of this section. this section for the significant new (2) The significant new uses are: uses described in paragraph (a)(2) of (i) Protection in the workplace. Re- this section. quirements as specified in § 721.63 (a)(1) (2) The significant new uses are: and (a)(3), (b) (concentration set at 0.1 (i) Protection in the workplace. Re- percent), and (c). quirements as specified in § 721.63 (a)(1), (ii) Hazard communication program. (a)(3), (b) (concentration set at 0.1 per- Requirements as specified in § 721.72 cent) and (c). (b)(2), (d), (e) (concentration set at 0.1 (ii) Hazard communication program. percent), (f), (g)(1)(vii) and (g)(2)(v). Requirements as specified in § 721.72 The provisions of § 721.72(d) requiring (b)(2), (c), (d), (e) (concentration set at employees to be provided with informa- 0.1 percent), (f), (g)(1)(iv), (g)(1)(ix), tion on the location and availability of (g)(2)(i), (g)(2)(v), and (g)(5). The provi- a written hazard communication pro- sion of § 721.72(d) requiring that em- gram and MSDSs do not apply when ployees to be provided with informa- the written program and MSDS are not tion on the location and availability of required under § 721.72 (a) and (c), re- a written hazard communication pro- spectively. The provision of § 721.72(g) gram does not apply when the written requiring placement of specific infor- program is not required under mation on a MSDS does not apply § 721.72(a). The provision of § 721.72(g) when a MSDS in not required under requiring placement of specific infor- § 721.72(c). mation on a label does not apply when (iii) Industrial, commercial, and con- a label is not required under § 721.72(b). sumer activities. Requirements as speci- (iii) Industrial, commercial, and con- fied in § 721.80(g). sumer activities. Requirements as speci- (iv) Disposal. Requirements as specified in § 721.80 (k) and (q). fied in § 721.85 (a)(1), (b)(1), and (c)(1). (iv) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(3), (b)(3), and sions of subpart A of this part apply to (c)(3). this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. The following rec- this section except as modified by this ordkeeping requirements are applicable paragraph. to manufacturers, importers, and proc- (1) Recordkeeping. The following rec- essors of this substance, as specified in ordkeeping requirements are applicable to manufacturers, importers, and proc- § 721.125 (a) through (c), (e), (f), and (i). essors of this substance, as specified in (2) Limitations or revocation of certain § 721.125 (a) through (c), (e), (f), (i) and notification requirements. The provisions (j). of § 721.185 apply to this significant new (2) Limitations or revocation of certain use rule. notification requirements. The provisions (3) Determining whether a specific use is of § 721.185 apply to this significant new subject to this section. The provisions of use rule. § 721.1725(b)(1) apply to this section. (3) Determining whether a specific use is [55 FR 32415, Aug. 9, 1990. Redesignated and subject to this section. The provisions of amended at 58 FR 29946, May 24, 1993; 58 FR § 721.1725(b)(1) apply to this section. 34204, June 23, 1993] [55 FR 32414, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, May 24, 1993; 58 FR § 721.2920 tert-Amyl peroxy alkylene 34204, June 23, 1993] ester (generic name). (a) Chemical substance and significant § 721.2900 Substituted aminobenzoic new uses subject to reporting. (1) The acid ester (generic name). chemical substance tert-amyl peroxy (a) Chemical substance and significant alkylene ester (PMN P-85–1180) is sub- new uses subject to reporting. (1) The ject to reporting under this section for

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the significant new uses described in (i) Hazard communication program. Re- paragraph (a)(2) of this section. quirements as specified in § 721.72 (a), (2) The significant new uses are: (b), (c), (d), (f), (g)(3)(1), (g)(3)(ii), (i) Protection in the workplace. Re- (g)(4)(iii), and (g)(5). quirements as specified in § 721.63 (a)(1) (ii) [Reserved] and (a)(3), (b) (concentration set at 1.0 (iii) Industrial, commercial, and con- percent), and (c). sumer activities. Requirements as speci- (ii) Hazard communication program. fied in § 721.80(q). Requirements as specified in § 721.72 (iv) Release to water. Requirements as (b)(2), (c), (d), (e) (concentration set at specified in § 721.90 (a)(1), (b)(1), and 1.0 percent), (f) and (g)(1)(vii), (g)(2)(i), (c)(1). (g)(2)(v), (g)(4)(i), and (g)(5). The provi- (b) Specific requirements. The provision of § 721.72(d) requiring that em- sions of subpart A of this part apply to ployees to be provided with informa- this section except as modified by this tion on the location and availability of paragraph. a written hazard communication pro- (1) Recordkeeping. Recordkeeping re- gram does not apply when the written quirements as specified in § 721.125 (a), program is not required under (b), (c), (f), (g), (h), (i), and (k) are ap- § 721.72(a). plicable to manufacturers, importers, (iii) Industrial, commercial, and con- and processors of this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(k). notification requirements. The provisions (iv) Disposal. Requirements as speci- of § 721.185 apply to this section. fied in § 721.85 (a)(1), (a)(2) and (a)(3), (3) Determining whether a specific use is (b)(1), (b)(2) and (b)(3). subject to this section. The provisions of (v) Release to water. Requirements as § 721.1725(b)(1) apply to this section. specified in § 721.90 (a)(2)(vi), (b)(2)(vi) [63 FR 3426, Jan. 22, 1998] and (c)(2)(vi). (b) Specific requirements. The provi- § 721.2950 Carboxylic acid glycidyl sions of subpart A of this part apply to esters. this section except as modified by this (a) Chemical substances and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping. The following rec- chemical substance identified generi- ordkeeping requirements are applicable cally as carboxylic acid glycidyl ester to manufacturers, importers, and proc- (PMN P-92–776) is subject to reporting essors of this substance, as specified in under this section for the significant § 721.125 (a) through (k). new uses described in this paragraph. (2) Limitations or revocation of certain (i) The significant new uses are: notification requirements. The provisions (A) Protection in the workplace. Re- of § 721.185 apply to this significant new quirements as specified in § 721.63 (a)(1), use rule. (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iii), (3) Determining whether a specific use is (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), subject to this section. The provisions of (a)(6)(i), (b) (concentration set at 0.1 § 721.1725(b)(1) apply to this section. percent), and (c). As an alternative to [55 FR 32413, Aug. 9, 1990. Redesignated and the respiratory requirements in this amended at 58 FR 29946, May 24, 1993; 58 FR section, manufacturers, importers, and 34204, June 23, 1993] processors may use the New Chemical Exposure Limits provisions, including § 721.2925 Brominated aromatic ester. sampling and analytical methods (a) Chemical substance and significant which have previously been approved new uses subject to reporting. (1) The by EPA for this substance, found in the chemical substance identified generi- 5(e) consent order for this substance. cally as a brominated aromatic ester (B) Hazard communication program. (PMN P-95–1128) is subject to reporting Requirements as specified in § 721.72 (a), under this section for the significant (b), (c), (d), (e) (concentration set at 0.1 new uses described in paragraph (a)(2) percent), (f), (g)(1)(i), (g)(1)(vi), of this section. (g)(1)(vii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (2) The significant new uses are: (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).

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(C) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80(q). (A) Recordkeeping. Recordkeeping re- (D) Release to water. Requirements as quirements as specified in § 721.125 (a) specified in § 721.90 (a)(1), (b)(1), and through (i) and (k) are applicable to (c)(1). manufacturers, importers, and proc- (ii) Specific requirements. The provi- essors of this substance. sions of subpart A of this part apply to (B) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this section. (A) Recordkeeping. Recordkeeping re- (C) Determining whether a specific use quirements as specified in § 721.125 (a) is subject to this section. The provisions through (i) and (k) are applicable to of § 721.1725(b)(1) apply to this section. manufacturers, importers, and proc- (b) [Reserved] essors of this substance. (B) Limitations or revocation of certain [59 FR 27483, May 27, 1994] notification requirements. The provisions § 721.3000 Dicarboxylic acid of § 721.185 apply to this section. monoester. (C) Determining whether a specific use is subject to this section. The provisions (a) Chemical substance and significant of § 721.1725(b)(1) apply to this section. new uses subject to reporting. (1) The fol- (2) The chemical substance identified lowing chemical substance referred to as carboxylic acid glycidyl ester (PMN by its premanufacture notice number P-92–777) is subject to reporting under and its generic chemical name is sub- this section for the significant new ject to reporting under this section for uses described in this paragraph. the significant new uses described in (i) The significant new uses are: paragraph (a)(2) of this section: (A) Protection in the workplace. Re- dicarboxylic acid monoester, P-83–255. quirements as specified in § 721.63 (a)(1), (2) The significant new uses are: (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i) (i) Any manufacture in the United (§ 721.63(a)(5)(i) applies only during States for commercial purposes. processing operations), (a)(5)(ii), (ii) Failure to require the use of (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), gloves determined to be impervious to (a)(5)(vii), (a)(6)(i), (b) (concentration the substance, and/or failure to require set at 0.1 percent), and (c). As an alter- the use of clothing to prevent dermal native to the respiratory requirements contact for any person involved in any in this section, manufacturers, import- processing or use operation where der- ers, and processors may use the New mal contact may occur. (Gloves may be Chemical Exposure Limits provisions, determined to be impervious to the including sampling and analytical substance either by testing the gloves methods which have previously been under the conditions of use or by rely- approved by EPA for this substance, ing on the manufacturer’s specifica- found in the 5(e) consent order for this tions.) substance. (iii) Distribution in commerce by any (B) Hazard communication program. person, including importers, proc- Requirements as specified in § 721.72 (a), essors, and distributors, without (b), (c), (d), (e) (concentration set at 0.1 affixing to each container of any for- percent), (f), (g)(1)(i), (g)(1)(ii), mulation containing the substance a (g)(1)(vi), (g)(1)(vii), (g)(2)(iii), (g)(2)(iv), label that includes, in letters no small- (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), er than 10 point type, the following and (g)(5). statements: (C) Industrial, commercial, and con- WARNING! HARMFUL IF INHALED OR sumer activities. Requirements as speci- ABSORBED THROUGH THE SKIN. MAY fied in § 721.80(q). CAUSE REPRODUCTIVE EFFECTS. (D) Release to water. Requirements as —Do not get in eye, on skin, or clothing. specified in § 721.90 (a)(1), (b)(1), and —Do not breathe (vapor, mist, spray, dust). (c)(1). —Use with adequate ventilation. (ii) Specific requirements. The provi- —Wear impervious gloves and protective sions of subpart A of this part apply to equipment to prevent contact or exposure.

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—Promptly remove contaminated non- (iii) Industrial, commercial, and con- imprevious clothing, wash before reuse. sumer activities. Requirements as speci- —Discard contaminated leather shoes. fied in § 721.80(k). —Wash thoroughly after handling, and be- (iv) Disposal. Requirements as speci- fore eating, drinking, or smoking. fied in § 721.85 (a)(3) and (b)(3). —Keep container closed. (b) Specific requirements. The provi- FIRST AID: In case of contact. sions of subpart A of this part apply to EYES: Immediately flush with water for at least 15 minutes. this section except as modified by this SKIN: Promptly wash thoroughly with paragraph. mild soap and water. (1) Recordkeeping. The following rec- INHALATION: Remove to fresh air. If ordkeeping requirements are applicable breathing is difficult, give oxygen. to manufacturers, importers, and proc- INGESTION: If conscious, give water and essors of this substance, as specified in induce vomiting. § 721.125 (a) through (k). (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this significant new paragraph. use rule. (3) Determining whether a specific use is (1) Recordkeeping. In addition to the The provisions of requirements of § 721.17, importers and subject to this section. § 721.1725(b)(1) apply to this section. processors of the chemical substance identified in paragraph (a)(1) of this [55 FR 26111, June 26, 1990. Redesignated and section must maintain the following amended at 58 FR 29946, 29947, May 24, 1993; 58 records for five years from their cre- FR 34204, June 23, 1993] ation: § 721.3025 Fatty acids C , C un- (i) The names of persons required to 12-18 18 saturated, C12-18 alkyl esters (ge- wear protective clothing. neric). (ii) The name and address of each (a) Chemical substance and significant person to whom the substance is sold new uses subject to reporting. (1) The or transferred and the date of such sale chemical substance identified generi- or transfer. cally as fatty acids C , C unsatu- (2) [Reserved] 12-18 18 rated, C12-18 alkyl esters (PMNs P-94–697 [49 FR 43064, Oct. 26, 1984. Redesignated at 53 through P-94–895) is subject to report- FR 2845, Feb. 2, 1988. Further redesignated at ing under this section for the signifi- 58 FR 29946, May 24, 1993, as amended at 58 cant new uses described in paragraph FR 34204, June 23, 1993] (a)(2) of this section. (2) The significant new uses are: § 721.3020 1,1-Dimethylpropyl peroxy- (i) Industrial, commercial, and con- ester (generic name). sumer activities. Requirements as speci- (a) Chemical substance and significant fied in § 721.80(p) (750,000 kilograms). new uses subject to reporting. (1) The (ii) Hazard communication program. A chemical substance 1,1-dimethylpropyl significant new use of these substances peroxyester (PMN P-85–680) is subject is any manner or method of manufac- to reporting under this section for the ture, import, or processing associated significant new uses described in para- with any use of these substances with- graph (a)(2) of this section. out providing risk notification as fol- (2) The significant new uses are: lows: (i) Protection in the workplace. Re- (A) If as a result of the test data requirements as specified in § 721.63 (a)(1), quired under the TSCA section 5(e) (a)(3), (a)(4), (a)(5)(i), and (a)(6)(v), (b) consent order for these substances, the [concentration set at 0.1 percent], and employer becomes aware that these (c). substances may present a risk of injury (ii) Hazard communication program. to human health or the environment, Requirements as specified in § 721.72 (a), the employer must incorporate this (b)(2), (c), (d), (e) [concentration set at new information, and any information 0.1 percent], (f), and (g)(1)(vii), (g)(2)(i), on methods for protecting against such (g)(2)(ii), (g)(2)(iv), and (g)(2)(v), and risk, into an MSDS as described in (g)(4)(i). § 721.72(c) within 90 days from the time

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the employer becomes aware of the new (2) Limitations or revocation of certain information. If this substance is not notification requirements. The provisions being manufactured, imported, proc- of § 721.185 apply to this section. essed, or used in the employer’s workplace, the employer must add the new [63 FR 44578, Aug. 20, 1998] information to an MSDS before the § 721.3032 Boric acid (H BO ), zinc salt. substances are reintroduced into the 3 2 workplace. (a) Chemical substance and significant (B) The employer must ensure that new uses subject to reporting. (1) The persons who will receive or who have chemical substance identified as boric received the substances from the em- acid (H3BO2), zinc salt (PMN P-97–553; ployer within 5 years from the date the CAS No. 14720–55–9) are subject to re- employer becomes aware of the new in- porting under this section for the sig- formation described in paragraph nificant new uses described in para- (a)(2)(i)(A), are provided an MSDS as graph (a)(2) of this section. described in § 721.72(c) containing the (2) The significant new uses are: information required under paragraph (i) Release to water. Requirements as (a)(2)(i)(A) within 90 days from the specified in § 721.90 (a)(4), (b)(4), and time the employer becomes aware of (c)(4) (N = 3). the new information. (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of these substances. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [65 FR 369, Jan. 5, 2000] [63 FR 44578, Aug. 20, 1998]

§ 721.3031 Boric acid (H3BO3), zinc salt (2=3). § 721.3034 Methylamine esters. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified as boric chemical substance identified generically as methylamine esters (PMN P- acid (H3BO3), zinc salt (2=3) (PMN P-97– 552; CAS No. 10192–46–8) is subject to re- 94–982) is subject to reporting under porting under this section for the sig- this section for the significant new nificant new uses described in para- uses described in paragraph (a)(2) of graph (a)(2) of this section. this section. (2) The significant new uses are: (2) The significant new uses are: (i) Release to water. Requirements as (i) Industrial, commercial, and con- specified in § 721.90 (a)(4), (b)(4), and sumer activities. Requirements as speci- (c)(4) (N = 3). fied in § 721.80(g). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping requirements. Rec- quirements as specified in § 721.125 (a), ordkeeping requirements specified in (b), (c), and (k) are applicable to manu- § 721.125 (a), (b), (c), and (i) are applica- facturers, importers, and processors of ble to manufacturers, importers, and this substance. processors of this substance.

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(2) Limitations or revocation of certain ers, importers, and processors of this notification requirements. The provisions substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [60 FR 11042, Mar. 1, 1995] of § 721.185 apply to this significant new § 721.3062 Haloarylalkylketoester (ge- use rule. neric). [61 FR 63736, Dec. 2, 1996] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.3080 Substituted phosphate ester (generic). chemical substance identified generically as a haloarylalkylketoester. (a) Chemical substances and significant (PMN P-00–966) is subject to reporting new uses subject to reporting. (1) The under this section for the significant chemical substance identified generi- new use described in paragraph (a)(2) of cally as a substituted phosphate ester this section. (PMN P-85–730) is subject to reporting (2) The significant new uses are: under this section for the significant (i) Release to water. Requirements as new uses described in paragraph (a)(2) specified in § 721.90(a)(4), (b)(4), and of this section. (c)(4) (N=200). (2) The significant new uses are: (ii) [Reserved] (i) Protection in the workplace. Re- (b) Specific requirements. The provi- quirements as specified in § 721.63 (a)(1), sions of subpart A of this part apply to (a)(3), (b) (concentration set at 0.1 per- this section except as modified by this cent), and (c). paragraph. (ii) Hazard communication program. Requirements as specified in § 721.72 (a), (1) Recordkeeping. Recordkeeping re- (b)(2), (c), (d), (e) (concentration set at quirements as specified in § 721.125(a), 0.1 percent), (f), (g)(1)(iv), (g)(1)(vii), (b), (c), and (k) are applicable to manu- (g)(2)(i), (g)(2)(v), and (g)(5). facturers, importers, and processors of (iii) Industrial, commercial, and con- this chemical substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(k). notification requirements. The provisions (iv) Release to water. Section 721.90 of § 721.185 apply to this section. (a)(1), (b)(1), and (c)(1). [68 FR 70176, Dec. 17, 2003] (b) Specific requirements. The provisions of subpart A of this part apply to § 721.3063 Substituted phenyl azo sub- this section except as modified by this stituted phenyl esters (generic paragraph. name). (1) Recordkeeping. The following rec- (a) Chemical substance and significant ordkeeping requirements are applicable new uses subject to reporting. (1) The to manufacturers, importers, and proc- chemical substances identified generi- essors of this substance, as specified in cally as substituted phenyl azo sub- § 721.125 (a) through (i). stituted phenyl esters (PMNs P-95–655, (2) Limitations or revocation of certain P-95–782 and P-95–871) are subject to re- notification requirements. The provisions porting under this section for the sig- of § 721.185 apply to this section. nificant new uses described in para- (3) Determining whether a specific graph (a)(2) of this section. use is subject to this section. The pro- (2) The significant new uses are: visions of § 721.1725(b)(1) apply to this (i) Industrial, commercial, and con- section. sumer activities. Requirements as speci- [55 FR 26100, June 26, 1990. Redesignated and fied in § 721.80(w)(1). amended at 58 FR 29946, 29947, May 24, 1993; 58 (ii) [Reserved] FR 34204, June 23, 1993] (b) Specific requirements. The provisions of subpart A of this part apply to § 721.3085 Brominated phthalate ester. this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping. Recordkeeping re- chemical substance identified generi- quirements as specified in § 721.125 (a) cally as brominated phthalate ester and (i) are applicable to manufactur- (PMN P-90–581) is subject to reporting

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under this section for the significant (3) Determining whether a specific use is new uses described in paragraph (a)(2) subject to this section. The provisions of of this section. § 721.1725(b)(1) apply to this section. (2) The significant new uses are: [63 FR 3426, Jan. 22, 1998] (i) Industrial, commercial, and consumer activities. Requirements as speci- § 721.3100 Oligomeric silicic acid ester fied in § 721.80(q). compound with a hydroxylalkyla- (ii) Hazard communication program. A mine. significant new use of this substance is (a) Chemical substance and significant any manner or method of manufacture, new uses subject to reporting. (1) The import, or processing associated with chemical substance identified generi- any use of these substances without cally as oligomeric silicic acid ester providing risk notification as follows. compound with a hydroxylalkylamine (A) If as a result of the test data re- (PMN P-91–118) is subject to reporting quired under the TSCA section 5(e) under this section for the significant consent order for this substance, the new uses described in paragraph (a)(2) employer becomes aware that this sub- of this section. stance may present a risk of injury to (2) The significant new uses are: human health or the environment the (i) Industrial, commercial, and con- employer must incorporate this new in- sumer activities. Requirements as specified in § 721.80(a). formation, and any information on (ii) [Reserved] methods for protecting against such (b) Specific requirements. The provi- risk, into a MSDS as described in sions of subpart A of this part apply to § 721.72(c) within 90 days from the time this section except as modified by this the employer becomes aware of the new paragraph. information. If this substance is not (1) Recordkeeping requirements. Re- being manufactured, imported, proc- quirements as specified in § 721.125 (a), essed, or used in the employer’s work- (b), (c), and (i) are applicable to manu- place, the employer must add the new facturers, importers, and processors of information to an MSDS before the this substance. substances are reintroduced into the (2) Limitations or revocation of certain workplace. notification requirements. The provisions (B) The employer must ensure that of § 721.185 apply to this section. persons who will receive, or who have received the substance from the em- [57 FR 46465, Oct. 8, 1992, as amended at 58 FR ployer within 5 years from the date the 34204, June 23, 1993] employer becomes aware of the new in- § 721.3110 Polycarboxylic acid ester formation described in paragraph (generic). (a)(2)(i)(A) of this section, are provided (a) Chemical substance and significant an MSDS as described in § 721.72(c) con- new uses subject to reporting. (1) The taining the information required under chemical substance identified generi- paragraph (a)(2)(i)(A) of this section cally as a polycarboxylic acid ester within 90 days from the time the em- (PMN P-97–1108) is subject to reporting ployer becomes aware of the new infor- under this section for the significant mation. new use described in paragraph (a)(1) of (b) Specific requirements. The provi- this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Release to water. Requirements as paragraph. specified in § 721.90(a)(1), (b)(1), and (1) Recordkeeping. Recordkeeping re- (c)(1). quirements as specified in § 721.125 (a), (ii) [Reserved] (b), (c), and (i) are applicable to manu- (b) Specific requirements. The provi- facturers, importers, and processors of sions of subpart A of this part apply to this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125(a),

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(b), (c), and (k) are applicable to manu- (1) Recordkeeping. Recordkeeping re- facturers, importers, and processors of quirements as specified in § 721.125(a), this chemical substance. (b), (c), and (k) are applicable to manu- (2) Limitations or evocation of certain facturers, importers, and processors of notification requirements. The provisions this chemical substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [68 FR 70176, Dec. 17, 2003] of § 721.185 apply to this section.

§ 721.3130 Sulfuric acid, mono-C9-11- [68 FR 70176, Dec. 17, 2003] alkyl esters, sodium salts. (a) Chemical substance and significant § 721.3140 Vinyl epoxy ester. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified as sul- new uses subject to reporting. (1) The furic acid, mono-C9–11-alkyl esters, so- chemical substance vinyl epoxy ester dium salts (PMN P-01–149; CAS No. (PMN P-85–527) is subject to reporting 84501–49–5) is subject to reporting under under this section for the significant this section for the significant new use new uses described in paragraph (a)(2) described in paragraph (a)(2) of this of this section. section. (2) The significant new uses are: (2) The significant new uses are: (i) Protection in the workplace. Re- (i) Industrial, commercial, and con- quirements as specified in § 721.63 (a)(1), sumer activities. Requirements as speci- (a)(3), (b) (concentration set at 0.1 per- fied in § 721.80(s) (5,000 kilogram (kg)). cent) and (c). (ii) [Reserved] (ii) Hazard communication program. (b) Specific requirements. The provi- Requirements as specified in § 721.72 sions of subpart A of this part apply to (b)(2), (c), (d), (e) (concentration set at this section except as modified by this 0.1 percent), (f), (g)(1)(iii), (g)(1)(vii), paragraph. (g)(2)(i) through (g)(2)(iii), (g)(2)(v), (1) Recordkeeping. Recordkeeping re- (g)(4)(i), and (g)(5). The provision of quirements as specified in § 721.125(a), § 721.72(d) requiring that employees to (b), (c), and (i) are applicable to manu- be provided with information on the lo- facturers, importers, and processors of cation and availability of a written this chemical substance. hazard communication program does (2) Limitations or revocation of certain not apply when the written program is notification requirements. The provisions not required under § 721.72(a). of § 721.185 apply to this section. (iii) Industrial, commercial, and consumer activities. Requirements as speci- [68 FR 70176, Dec. 17, 2003] fied in § 721.80 (k) (as an injection molding coating), and (y). § 721.3135 Phosphorous modified (iv) Disposal. Requirements as speci- epoxy resin (generic). fied in § 721.85 (a)(2), (b)(2), and (c)(2). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as a phosphorous modified epoxy paragraph. resin (PMNs P-00–992 and P-01–471) is (1) Recordkeeping. The following rec- subject to reporting under this section ordkeeping requirements are applicable for the significant new use described in to manufacturers, importers, and proc- paragraph (a)(2) of this section. essors of this substance, as specified in (2) The significant new uses are: § 721.125 (a), (b), (c), (e), (f), (g), (h), and (i) Release to water. Requirements as (j). specified § 721.90(a)(4), (b)(4), and (c)(4) (2) Limitations or revocation of certain (N=6). notification requirements. The provisions (ii) [Reserved] of § 721.185 apply to this significant new (b) Specific requirements. The provi- use rule. sions of subpart A of this part apply to [55 FR 39900, Sept. 28, 1990. Redesignated at this section except as modified by this 58 FR 29946, May 24, 1993, as amended at 58 paragraph. FR 34204, June 23, 1993]

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§ 721.3152 Ethanaminium, N-ethyl-2- (1) Recordkeeping. Recordkeeping re- hydroxy-N,N-bis(2-hydroxyethyl)-, quirements as specified in § 721.125 (a), diester with C12-18 fatty acids, ethyl (h), and (i) are applicable to manufac- sulfates (salts). turers, importers, and processors of (a) Chemical substance and significant this substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance ethanaminium, N- notification requirements. The provisions ethyl-2-hydroxy-N,N-bis(2-hydroxy- of § 721.185 apply to this section. ethyl)-, diester with C12-18 fatty acids, (3) Determining whether a specific use is ethyl sulfates (salts) (P-94–24) is sub- subject to this section. The provisions of ject to reporting under this section for § 721.1725(b)(1) apply to this section. the significant new uses described in paragraph (a)(2) of this section. [60 FR 45081, Aug. 30, 1995] (2) The significant new uses are: § 721.3155 3,8-Dioxa-4,7-disiladecane, (i) Hazard communication program. A 4,4,7,7-tetraethoxy-. significant new use of this substance is any manner or method of manufacture, (a) Chemical substance and significant import, or processing associated with new uses subject to reporting. (1) The any use of this substance without pro- chemical substance identified as 3,8- viding risk notification as follows: dioxa-4,7-disiladecane, 4,4,7,7- (A) If as a result of the test data re- tetraethoxy- (PMN P-95–1326; CAS No. quired under the section 5(e) consent 16068–37–4) is subject to reporting under order for this substance, the employer this section for the significant new becomes aware that this substance uses described in paragraph (a)(2) of may present a risk of injury to human this section. health or the environment the em- (2) The significant new uses are: ployer must incorporate this new infor- (i) Industrial, commercial, and con- mation, and any information on meth- sumer activities. Requirements as speci- ods for protecting against such risk, fied in § 721.80(y)(1). into a material safety data sheet (ii) [Reserved] (MSDS) as described in § 721.72(c) with- (b) Specific requirements. The provi- in 90 days from the time the employer sions of subpart A of this part apply to becomes aware of the new information. this section except as modified by this If this substance is not being manufac- paragraph. tured, imported, processed, or used in (1) Recordkeeping. Recordkeeping re- the employer’s workplace, the em- quirements as specified in § 721.125 (a), ployer must add the new information (b), (c), and (i) are applicable to manu- to an MSDS before the substance is re- facturers, importers, and processors of introduced into the workplace. this substance. (B) The employer must ensure that (2) Limitations or revocation of certain persons who will receive, or who have notification requirements. The provisions received, this substance from the em- of § 721.185 apply to this section. ployer within 5 years from the date the employer becomes aware of the new in- [63 FR 3426, Jan. 22, 1998] formation described in paragraph § 721.3160 1-Chloro-2-bromoethane. (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) con- (a) Chemical substance and significant taining the information required under new use subject to reporting. (1) The paragraph (a)(2)(i)(A) of this section chemical substance 1-chloro-2- within 90 days from the time the em- bromoethane (CAS No. 107–04–0) is sub- ployer becomes aware of the new infor- ject to reporting under this section for mation. the significant new use described in (ii) Industrial, commercial, and con- paragraph (a)(2) of this section. sumer activities. Requirements as speci- (2) The significant new use is: any fied in § 721.80(p) (1,900,000 kg). use. (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph.

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(1) Persons who must report. Section (b) Specific requirements. The provi- 721.5 applies to this section except for sions of subpart A of this part apply to § 721.5(a)(2). A person who intends to this section except as modified by this manufacture, import, or process for paragraph. commercial purposes the substance (1) Recordkeeping. Recordkeeping re- identified in paragraph (a)(1) of this quirements as specified in § 721.125 (a), section and intends to distribute the (b), (c), and (i) are applicable to manu- substance in commerce must submit a facturers, importers, and processors of significant new use notice. this substance. (2) [Reserved] (2) Limitations or revocation of certain [53 FR 2845, Feb. 2, 1988. Redesignated at 58 notification requirements. The provisions FR 29946, May 24, 1993, as amended at 58 FR of § 721.185 apply to this significant new 34204, June 23, 1993] use rule.

§ 721.3220 Pentachloroethane. [58 FR 32237, June 8, 1993] (a) Chemical substance and significant § 721.3260 Ethanediimidic acids. (1) The new use subject to reporting. (a) Chemical substance and significant chemical substance pentachloroethane, new uses subject to reporting. (1) The CAS Number 76–01–7, is subject to re- chemical substances identified as porting under this section for the sig- ethanediimidic acids (PMNs P-90–1472 nificant new use described in paragraph and P-90–1473), are subject to reporting (a)(2) of this section. under this section for the significant (2) The significant new use is any new uses described in paragraph (a)(2) use. of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 (a)(4), paragraph. (a)(5)(i), (a)(6)(i), (b) (concentration set (1) Persons who must report. Section at 0.1 percent), and (c). 721.5 applies to this section except for (ii) Hazard communication program. § 721.5(a)(2). A person who intends to Requirements as specified in § 721.72 (a), manufacture, import, or process for (b), (c), (d), (e), (concentration set at 0.1 commercial purposes the substance percent), (f), (g)(1)(iv), (g)(1)(vii), identified in paragraph (a)(1) of this (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), section and intends to distribute the (g)(4)(ii), (g)(4)(iii), and (g)(5). substance in commerce must submit a significant new use notice. (iii) Industrial, commercial, and con- (2) [Reserved] sumer activities. Requirements as specified in § 721.80(q). [51 FR 32079, Sept. 9, 1986. Redesignated at 53 (iv) Release to water. Requirements as FR 2845, Feb. 2, 1988 and correctly redesig- specified in § 721.90 (a)(1) and (b)(1). nated at 56 FR 29903, July 1, 1991. Further re- (b) Specific requirements. The provi- designated at 58 FR 29947, May 24, 1993, as amended at 58 FR 34204, June 23, 1993] sions of subpart A of this part apply to this section except as modified by this § 721.3248 Ethane, 1,2,2- paragraph. trichlorodifluoro-. (1) Recordkeeping requirements. Re- (a) Chemical substance and significant quirements as specified in § 721.125 (a) new uses subject to reporting. (1) The through (i), and (k) are applicable to chemical substance identified as eth- manufacturers, importers, and proc- ane, 1,2,2-trichlorodifluoro- (CAS No. essors of this substance. 354–21–2, PMN No. P-92–595) is subject (2) Limitations or revocation of certain to reporting under this section for the notification requirements. The provisions significant new uses described in para- of § 721.185 apply to this section. graph (a)(2) of this section. (3) Determining whether a specific use is (2) The significant new uses are: subject to this section. The provisions of (i) Industrial, commercial, and con- § 721.1725(b)(1) apply to this section. sumer activities. Requirements as speci- [57 FR 44065, Sept. 23, 1992, as amended at 58 fied in § 721.80(g). FR 29946, May 24, 1993; 58 FR 34204, June 23, (ii) [Reserved] 1993]

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§ 721.3310 Poly[oxy(methyl-1,2- (iii) Industrial, commercial, and con- ethanediyl)],α-(1-oxo-2-propenyl)-w- sumer activities. Requirements as speci- [(tetrahydro-2-furanyl)methoxy]-. fied in § 720.80(k) (monomer stabilizer). (a) Chemical substance and significant (iv) Disposal. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), chemical substance identified as (c)(1), and (c)(2). (b) Specific requirements. The provi- poly[oxy(methyl-1,2-ethanediyl)],a-(1- sions of subpart A of this part apply to oxo-2-propenyl)- -[(tetrahydro-2- w this section except as modified by this furanyl)methoxy]- (PMN P-98–150; CAS paragraph. No.149303–87–7) is subject to reporting (1) Recordkeeping. The following rec- under this section for the significant ordkeeping requirements are applicable new uses described in paragraph (a)(2) to manufacturers, importers, and proc- of this section. essors of this substance, as specified in (2) The significant new uses are: § 721.125 (a) through (j). (i) Industrial, commercial, and con- (2) Limitations or revocation of certain sumer activities. Requirements as speci- notification requirements. The provisions fied in § 721.80. Manufacture of the PMN of § 721.185 apply to this significant new substance with an average number of use rule. moles of propoxy group between 5 and [56 FR 25990, June 5, 1991. Redesignated at 58 14. FR 29946, May 24, 1993, as amended at 58 FR (ii) [Reserved] 34204, June 23, 1993] (b) Specific requirements. The provisions of subpart A of this part apply to § 721.3340 Ethanol, 2,2′- this section except as modified by this (hexylamino)bis-. paragraph. (a) Chemical substance and significant (1) Recordkeeping. Recordkeeping renew uses subject to reporting. (1) The quirements as specified in § 721.125 (a) chemical substance identified as eth- and (i) are applicable to manufactur- anol, 2,2′-(hexylamino)bis- (PMN P-91– ers, importers, and processors of this 1346) is subject to reporting under this substance. section for the significant new uses de- (2) Limitations or revocation of certain scribed in paragraph (a)(2) of this sec- notification requirements. The provisions tion. of § 721.185 apply to this section. (2) The significant new uses are: (i) Release to water. Requirements as [65 FR 369, Jan. 5, 2000] specified in § 721.90 (a)(1), (b)(1), and (c)(1). § 721.3320 Ethanol, 2-amino-, com- (ii) [Reserved] pound with N-hydroxy-N-nitro- (b) Specific requirements. The provi- sobenzenamine (1:1). sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified as eth- (1) Recordkeeping requirements. Rec- anol, 2-amino-, compound with N-hy- ordkeeping requirements as specified droxy-N-nitrosobenzenamine (1:1) (P- at § 721.125 (a), (b), (c), and (k) are appli- 86–542), is subject to reporting under cable to manufacturers, importers, and this section for the significant new processors of this substance. uses described in paragraph (a)(2) of (2) Limitations or revocation of certain this section. notification requirements. The provisions (2) The significant new uses are: of § 721.185 apply to this section. (i) Protection in the workplace. Re- [57 FR 31968, July 20, 1992, as amended at 58 quirements as specified in § 721.63 (a)(1), FR 34204, June 23, 1993] (a)(3), (b) (concentration set at 0.1 percent), and (c). § 721.3350 N-Nitrosodiethanolamine. (ii) Hazard communication program. (a) Chemical substance and significant Requirements as specified in § 721.72 (a), new use subject to reporting. (1) The (b)(2), (c), (d), (e) (concentration set at chemical substance N- 0.1 percent), (f), (g)(1)(iv), (g)(1)(vii), nitrosodiethanolamine (CAS No. 1116– (g)(2)(i), and (g)(2)(v). 54–7) is subject to reporting under this

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section for the significant new use described in paragraph (a)(2) of this sec- scribed in paragraph (a)(2) of this section. tion. (2) The significant new uses are: (2) The significant new use is: Manu- (i) Release to water. Requirements as facture, import, or processing of 10,000 specified in § 721.90 (a)(1), (b)(1), and pounds or more per year per facility for (c)(1). any use. (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. The following rec- (1) Recordkeeping. Recordkeeping re- ordkeeping requirements are applicable quirements as specified in § 721.125 (a), to manufacturers, importers, and proc- (b), (c), and (k) are applicable to manu- essors of this substance, as specified in facturers, importers, and processors of § 721.125 (a), (b), and (c). this substance. (2) [Reserved] (2) Limitations or revocation of certain notification requirements. The provisions [58 FR 63517, Dec. 1, 1993] of § 721.185 apply to this section. § 721.3360 Substituted ethanolamine. [59 FR 27484, May 27, 1994] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.3374 Alkylenediolalkyl ether. chemical substance identified generi- (a) Chemical substance and significant cally as substituted ethanolamine new uses subject to reporting. (1) The (PMN P-91–490) is subject to reporting chemical substance identified as an under this section for the significant alkylenediolalkyl ether (PMN P-93–362) new uses described in paragraph (a)(2) is subject to reporting under this sec- of this section. tion for the significant new uses de- (2) The significant new uses are: scribed in paragraph (a)(2) of this sec- (i) Industrial, commercial, and con- tion. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80 (v)(1), (v)(2), (w)(1), (i) Industrial, commercial and consumer (w)(2), (x)(1), (x)(2), (y)(1), and (y)(2). activities. Requirements as specified in (ii) Release to water. Requirements as § 721.80(f). specified in § 721.90(a)(4), (b)(4), and (ii) [Reserved] (c)(4) (N = 1 ppb). (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping requirements. Re- quirements as specified in § 721.125 (a) quirements as specified in § 721.125(a), and (i) are applicable to manufactur- (b), (c), (i), and (k) are applicable to ers, importers, and processors of this manufacturers, importers, and proc- substance. essors of this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [58 FR 51684, Oct. 4, 1993] [57 FR 46466, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993] § 721.3380 Anilino ether. (a) Chemical substances and significant § 721.3364 Aliphatic ether. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as anilino ether (P-83–910) is sub- chemical substance identified generi- ject to reporting under this section for cally as an aliphatic ether (PMN P-93– the significant new uses described in 1381) is subject to reporting under this paragraph (a)(2) of this section. section for the significant new uses de- (2) The significant new uses are:

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(i) Protection in the workplace. Re- (2) Limitations or revocation of certain quirements as specified in § 721.63 (a)(1) notification requirements. The provisions and (a)(3). of § 721.185 apply to this section. (ii) Hazard communication program. [56 FR 25990, June 5, 1991. Redesignated at 58 Requirements as specified in § 721.72 FR 29946, May 24, 1993, as amended at 58 FR (b)(1)(i)(D) and (g)(2)(v). The provision 34204, June 23, 1993] of § 721.72(g) requiring placement of specific information in an MSDS does § 721.3430 4-Bromophenyl phenyl ether. not apply when an MSDS is not required under § 721.72(c). (a) Chemical substance and significant (1) The (b) Specific requirements. The provi- new use subject to reporting. chemical substance 4-bromophenyl sions of subpart A of this part apply to phenyl ether (CAS No. 101–55–3) is sub- this section except as modified by this ject to reporting under this section for paragraph. the significant new use described in (1) Recordkeeping. The following rec- paragraph (a)(2) of this section. ordkeeping requirements are applicable (2) The significant new use is: Manu- to manufacturers, importers, and proc- facture, import, or processing of 10,000 essors of this substance: § 721.125 (a), pounds or more per year per facility for (b), (c), (d), (f), and (g). any use. (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this paragraph. [56 FR 25989, June 5, 1991. Redesignated at 58 (1) Recordkeeping. The following rec- FR 29946, May 24, 1993, as amended at 58 FR ordkeeping requirements are applicable 34204, June 23, 1993] to manufacturers, importers, and processors of this substance, as specified in § 721.3420 Brominated arylalkyl ether. § 721.125 (a), (b), and (c). (a) Chemical substances and significant (2) [Reserved] new uses subject to reporting. (1) The [58 FR 63517, Dec. 1, 1993] chemical substance identified generically as brominated arylalkyl ether (P- § 721.3435 Butoxy-substituted ether al- 83–906) is subject to reporting under kane. this section for the significant new (a) Chemical substance and significant uses described in paragraph (a)(2) of new uses subject to reporting. (1) The this section. chemical substance identified generi- (2) The significant new uses are: cally as butoxy-substituted ether al- (i) Protection in the workplace. Re- kane (PMN P-92–755) is subject to requirements as specified in § 721.63 (a)(1) porting under this section for the sig- and (a)(3). nificant new uses described in para- (ii) Hazard communication program. graph (a)(2) of this section. Requirements as specified in § 721.72 (2) The significant new uses are: (i) Protection in the workplace. Re- (b)(1)(i)(D) and (g)(2)(v). The provision quirements as specified in § 721.63 (a)(1), of § 721.72(g) requiring placement of (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (b) specific information in an MSDS does (concentration set at 1.0 percent), and not apply when an MSDS is not re- (c). In addition, the employer must be quired under § 721.72(c). able to demonstrate that the gloves se- (b) Specific requirements. The provi- lected for handling the chemical sub- sions of subpart A of this part apply to stance provide an impervious barrier to this section except as modified by this prevent dermal exposure during normal paragraph. and expected duration and conditions (1) Recordkeeping. The following rec- of exposure within the work area by ordkeeping requirements are applicable testing the material used to make the to manufacturers, importers, and proc- gloves and the construction of the essors of this substance: § 721.125 (a), gloves to establish that they will be (b), (c), (d), (f), and (g). impervious for the expected duration and conditions of exposure. The testing

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must subject the gloves to the expected § 721.3437 Dialkyl ether. conditions of exposure, including the likely combinations of chemical sub- (a) Chemical substance and significant stances to which the gloves may be ex- new uses subject to reporting. (1) The posed in the work area. There must be chemical substance identified generi- no permeation of the gloves by the cally as dialkyl ether (PMN P-93–1308) chemical substance (or an EPA-ap- is subject to reporting under this sec- proved analogue) greater than 0.16 μg/ tion for the significant new uses de- cm2/min after 8 h of testing in accord- scribed in paragraph (a)(2) of this sec- ance with the most recent versions of tion. the American Society for Testing and (2) The significant new uses are: Materials (ASTM) F739 ‘‘Standard Test (i) Release to water. Requirements as Method for Resistance of Protective specified in § 721.90 (a)(4), (b)(4), and Clothing Materials to Permeation by (c)(4) (where N = 180 ppb). Liquids or Gases’’ and ASTM F1194 (ii) [Reserved] ‘‘Guide for Documenting the Results of (b) Specific requirements. The provi- Chemical Permeation Testing of Pro- sions of subpart A of this part apply to tective Clothing Materials.’’ The em- this section except as modified by this ployer must submit all test data to the paragraph. Agency and must receive written Agen- (1) Recordkeeping requirements. Rec- cy approval of the test results for each ordkeeping requirements specified in type of glove tested prior to use of such § 721.125 (a), (b), (c), and (k) are applica- gloves. Nitrile gloves with a minimum ble to manufacturers, importers, and thickness of 0.5588 mm have already processors of this substance. been tested and found to satisfy the (2) Limitations or revocation of certain terms of this section. Gloves contami- notification requirements. The provisions nated with the PMN substance shall be of § 721.185 apply to this section. disposed of after every work shift. (ii) Hazard communication program. [60 FR 11042, Mar. 1, 1995] Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 § 721.3438 Chlorohydroxyalkyl butyl percent), (f), (g)(1)(ix), (g)(2)(i), ether (generic). (g)(2)(v), and (g)(5). In addition, the (a) Chemical substance and significant human health hazard statements shall new uses subject to reporting. (1) The include a statement that this sub- chemical substance identified generi- stance may cause systemic toxicity cally as chlorohydroxyalkyl butyl and blood effects. ether (PMN P-99–1295) is subject to re- (iii) Industrial, commercial, and con- porting under this section for the sig- sumer activities. Requirements as speci- nificant new use described in paragraph fied in § 721.80 (g) and (q). (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified in § 721.90(a)(4), (b)(4), and paragraph. (c)(4) (N=3). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a) (ii) [Reserved] through (i) and records documenting (b) Specific requirements. The provi- compliance with the glove perme- sions of subpart A of this part apply to ability testing requirements of this this section except as modified by this section are applicable to manufactur- paragraph. ers, importers, and processors of this (1) Recordkeeping. Recordkeeping re- substance. quirements as specified in § 721.125(a), (2) Limitations or revocation of certain (b), (c), and (k) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this chemical substance. (3) Determining whether a specific use is (2) Limitations or revocation of certain subject to this section. The provisions of notification requirements. The provisions § 721.1725(b)(1) apply to this section. of § 721.185 apply to this section. [58 FR 51684, Oct. 4, 1993] [68 FR 70177, Dec. 17, 2003]

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§ 721.3440 Haloalkyl substituted cyclic (A) Protection in the workplace. Re- ethers. quirements as specified in § 721.63 (a)(1), (a) Chemical substance and significant (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), new uses subject to reporting. (1) The (a)(5)(iii), and (a)(6)(v) and (a)(6)(vi), (b) chemical substances haloalkyl sub- [concentration set at 0.1 percent], and stituted cyclic ethers (PMN P-85–368 (c). and P-85–369) are subject to reporting (B) Hazard communication program. under this section for the significant Requirements as specified in § 721.72 (a), new uses described in this paragraph. (d), (e) [concentration set at 0.1 per- (i) The significant new uses are: cent], (f), and (g)(1)(iii), (g)(1)(vii), (A) Protection in the workplace. Re- (g)(2)(i), (g)(2)(ii), (g)(2)(iv) and (g)(2)(v), quirements as specified in § 721.63 (a)(1), and (g)(5). The provision of § 721.72(d) (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii) requiring that employees be provided and (a)(6)(v) and (a)(6)(vi), (b) [con- with information on the location and centration set at 1.0 percent], and (c). availability of MSDSs does not apply (B) Hazard communication program. when a MSDS was not required under Requirements as specified in § 721.72 (a), § 721.72(c). The provisions of § 721.72(g) (d), (e) [concentration set at 1.0 per- requiring placement of specific infor- cent], (f), and (g)(1)(iii), (g)(2)(i), mation on a label and MSDS do not (g)(2)(ii), (g)(2)(iv) and (g)(2)(v), and apply when a label and MSDS are not (g)(5). The provision of § 721.72(d) re- required under § 721.72 (b) and (c), requiring that employees be provided spectively. with information on the location and (C) Industrial, commercial, and con- availability of MSDSs does not apply sumer activities. Requirements as speci- when a MSDS was not required under fied in § 721.80(k). § 721.72(c). The provisions of § 721.72(g) (D) Disposal. Requirements as speci- requiring placement of specific infor- fied in § 721.85 (a)(1), (a)(2), (b)(1) and mation on a label and MSDS do not (b)(2), and (c)(1) and (c)(2). apply when a label and MSDS are not (ii) Specific requirements. The provi- required under § 721.72 (b) and (c), re- sions of subpart A of this part apply to spectively. this section except as modified by this (C) Industrial, commercial, and con- paragraph. sumer activities. Requirements as speci- (A) Recordkeeping. The following rec- fied in § 721.80(k). ordkeeping requirements are applicable (D) Disposal. Requirements as speci- to manufacturers, importers, and proc- fied in § 721.85 (a)(1) and (a)(2), (b)(1) essors of this substance, as specified in and (b)(2), and (c)(1) and (c)(2). § 721.125 (a) through (k). (ii) Specific requirements. The provi- (B) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this significant new paragraph. use rule. (A) Recordkeeping. The following rec- (C) Determining whether a specific use ordkeeping requirements are applicable is subject to this section. The provisions to manufacturers, importers, and proc- of § 721.1725(b)(1) apply to this section. essors of the substances, as specified in (b) [Reserved] § 721.125 (a) through (k). [55 FR 26109, June 26, 1990. Redesignated and (B) Limitations or revocation of certain amended at 58 FR 29946, May 24, 1993; 58 FR notification requirements. The provisions 34204, June 23, 1993] of § 721.185 apply to this significant new use rule. § 721.3465 Stilbene diglycidyl ether. (C) Determining whether a specific use (a) Chemical substance and significant is subject to this section. The provisions new uses subject to reporting. (1) The of § 721.1725(b)(1) apply to this section. chemical substance identified as stil- (2) The chemical substance haloalkyl bene diglycidyl ether (PMN P-96–1427) substituted cyclic ether (PMN P-85–367) is subject to reporting under this sec- is subject to reporting under this section for the significant new uses de- tion for the significant new uses described in paragraph (a)(2) of this sec- scribed in this paragraph. tion. (i) The significant new uses are: (2) The significant new uses are:

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(i) Protection in the workplace. Re- (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (b) (con- quirements as specified in § 721.63 (a)(1), centration set at 0.1 percent) and (c). (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii), (ii) Hazard communication program. (a)(5)(iv), (a)(5)(v), (a)(6)(i), (b) (con- Requirements as specified in § 721.72 (a), centration set at 0.1 percent), and (c). (b), (c), (d), (e) (concentration set at 0.1 As an alternative to the respiratory percent), (f), (g)(1)(i), (g)(1)(ii), protection requirements of this sec- (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(i)(vii), tion, manufacturers, importers, and (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), processors of this substance may follow (g)(2)(v), (g)(3)(ii) and (g)(5). the terms of the new chemical exposure (iii) Industrial, commercial, and con- limits section in the TSCA section 5(e) sumer activities. Requirements as speci- consent order for this substance. fied in § 721.80(l). (ii) Hazard communication program. (b) Specific requirements. The provi- Requirements as specified in § 721.72 (a), sions of subpart A of this part apply to (b), (c), (d), (e) (concentration set at 1.0 this section except as modified by this percent), (f), (g)(1)(ii), (g)(1)(vi), paragraph. (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (1) Recordkeeping requirements. Re- (g)(2)(v), and (g)(5). The label and quirements as specified in § 721.125 (a) MSDS as required by this paragraph through (i) are applicable to manufac- shall also include the following state- turers, importers, and processors of ment: When using this substance use this substance. respiratory protection or maintain (2) Limitations or revocation of certain workplace airborne concentrations at notification requirements. The provisions or below an 8-hour time-weighted aver- of § 721.185 apply to this section. 3 age of 0.5 milligram (mg)/meter (m ). [57 FR 44065, Sept. 23, 1992, as amended at 58 (iii) Industrial, commercial, and con- FR 34204, June 23, 1993] sumer activities. Requirements as specified in § 721.80(q). § 721.3485 Hydrofluorocarbon alkyl (b) Specific requirements. The provi- ether. sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified generi- (1) Recordkeeping. Recordkeeping re- cally as a hydrofluorocarbon alkyl quirements as specified in § 721.125 (a), ether (PMN P-95–1578) is subject to re- (b), (c), (d), (e), (f), (g), (h), and (i) are porting under this section for the sig- applicable to manufacturers, import- nificant new uses described in para- ers, and processors of this substance. graph (a)(2) of this section. Non-spray (2) Limitations or revocation of certain uses are exempt from the provisions of notification requirements. The provisions this rule. of § 721.185 apply to this section. (2) The significant new uses are: (3) Determining whether a specific use is (i) Protection in the workplace. Re- subject to this section. The provisions of quirements as specified in § 721.63 (a)(4), § 721.1725(b)(1) apply to this section. (a)(5)(iii), and (a)(6)(v). [63 FR 3426, Jan. 22, 1998] (ii) Industrial, commercial, and consumer activities. Requirements as speci- § 721.3480 Halogenated biphenyl fied in § 721.80(g). glycidyl ethers. (b) Specific requirements. The provi- (a) Chemical substance and significant sions of subpart A of this part apply to new uses subject to reporting. (1) The this section except as modified by this chemical substances identified generi- paragraph. cally as halogenated biphenyl glycidyl (1) Recordkeeping. Recordkeeping re- ethers (PMNs P-90–1844, P-90–1845, and quirements as specified in § 721.125 (a), P-90–1846) are subject to reporting (b), (c), (d), and (i) are applicable to under this section for the significant manufacturers, importers, and proc- new uses described in paragraph (a)(2) essors of this substance. (2) Limitations or revocation of certain of this section. (2) The significant new uses are: notification requirements. The provisions (i) Protection in the workplace. Re- of § 721.185 apply to this section. quirements as specified in § 721.63 (a)(1), [63 FR 3427, Jan. 22, 1998]

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§ 721.3486 Polyglycerin mono(4- (2) Limitations or revocation of certain nonylphenyl) ether. notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The [63 FR 3427, Jan. 22, 1998] chemical substance identified generically as a polyglycerin mono(4- § 721.3500 Perhalo alkoxy ether. nonylphenyl) ether (PMN P-94–2230) is (a) Chemical substance and significant subject to reporting under this section new uses subject to reporting. (1) The for the significant new uses described chemical substance identified generi- in paragraph (a)(2) of this section. cally as perhalo alkoxy ether (PMN P- (2) The significant new uses are: 83–1227) is subject to reporting under (i) Release to water. Requirements as this section for the significant new specified in § 721.90 (a)(1), (b)(1), and uses described in paragraph (a)(2) of (c)(1). this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Protection in the workplace. Re- sions of subpart A of this part apply to quirements as specified in § 721.63 (a)(1), this section except as modified by this (a)(3), (a)(4), (a)(5)(i) through (a)(5)(iii), paragraph. (a)(6)(v), (a)(6)(vi), (b) (concentration (1) Recordkeeping. Recordkeeping re- set at 1.0 percent), and (c). quirements as specified in § 721.125 (a), (ii) Hazard communicatiom program. (b), (c), and (k) are applicable to manu- Requirements as specified in § 721.72 (d), facturers, importers, and processors of (e) (concentration set at 1.0 percent), this substance. (f), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (2) Limitations or revocation of certain (g)(2)(iv), and (g)(2)(v). The provisions notification requirements. The provisions of § 721.72(d) requiring employees to be of § 721.185 apply to this section. provided with information on the loca- [60 FR 45082, Aug. 30, 1995] tion and availability of a written hazard communication program and § 721.3488 Poly(oxy-1,2-ethanediyl), MSDSs do not apply when the written alpha substituted-omega-hydroxy-, program and MSDS are not required C16-20 alkyl ethers. under § 721.72 (a), and (c), respectively. (a) Chemical substance and significant The provisions of § 721.72(g) requiring new uses subject to reporting. (1) The placement of specific information on a chemical substance identified generi- label and MSDS do not apply when a cally as poly(oxy-1,2-ethanediyl), alpha label and MSDS are not required under § 721.72 (b), and (c), respectively. substituted-omega-hydroxy-, C16-20 alkyl ethers (PMN P-87–323) is subject (iii) Industrial, commercial, and con- to reporting under this section for the sumer activities. Requirements as speci- significant new uses described in para- fied in § 721.80(h). graph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.90 (a)(4), (b)(4), and (c)(4) (N (1) Recordkeeping. The following rec- = 20). ordkeeping requirements are applicable (ii) [Reserved] to manufacturers, importers, and proc- (b) Specific requirements. The provi- essors of this substance, as specified in sions of subpart A of this part apply to § 721.125 (a), (b), (c), (e), and (f). this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this significant new quirements as specified in § 721.125 (a), use rule. (b), (c), and (k) are applicable to manu- [55 FR 46772, Nov. 6, 1990. Redesignated at 58 facturers, importers, and processors of FR 29946, May 24, 1993, as amended at 58 FR this substance. 34204, June 23, 1993]

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§ 721.3520 Aliphatic polyglycidyl ether. weight of the specific isomer, propane, ′ (a) Chemical substance and significant 2,2 -oxybis[1-methoxy- (CAS No. 189354– new uses subject to reporting. (1) The 80–1), which is one of the possible prod- chemical substance aliphatic ucts of the manufacturing process for polyglycidyl ether (PMN P-89–1036) is PMN P-93–507. subject to reporting under this section (2) The significant new uses are: for the significant new uses described (i) Protection in the workplace. Re- in paragraph (a)(2) of this section. quirements as specified in § 721.63 (a)(1), (2) The significant new uses are: (a)(2)(i), and (a)(3). (i) Protection in the workplace. Re- (ii) Industrial, commercial, and con- quirements as specified in § 721.63 (a)(1), sumer activities. Requirements as speci- (a)(3), (a)(4), (a)(5)(iv) through (a)(5) fied in § 721.80(o). (vii), (a)(6)(i), (a)(6)(ii), (b) (concentra- (b) Specific requirements. The provi- tion set at 0.1 percent), and (c). sions of subpart A of this part apply to (ii) Hazard communication program. this section except as modified by this Requirements as specified in § 721.72 (a), paragraph. (b), (c), (d), (e) (concentration set at 0.1 (1) Recordkeeping requirements. The percent), (f), (g)(1)(vi), (g)(1)(vii), following recordkeeping requirements (g)(2)(i), (g)(2)(ii), (g)(3)(ii), (g)(4)(iii), specified in § 721.125 (a), (b), (c), (d), and and (g)(5). (e) are applicable to manufacturers, (iii) Industrial, commercial, and con- importers, and processors of this sub- sumer activities. Requirements as speci- stance. fied in § 721.80(q). (2) Limitations or revocation of certain (iv) Release to water. Requirements as notification requirements. The provisions specified in § 721.90 (a)(1), (b)(1), and of § 721.185 apply to this section. (c)(1). (b) Specific requirements. The provi- [62 FR 59583, Nov. 4, 1997; 62 FR 63035, Nov. 26, sions of subpart A of this part apply to 1997] this section except as modified by this paragraph. § 721.3560 Derivative of tetrachloroethylene. (1) Recordkeeping. The following recordkeeping requirements are applicable (a) Chemical substance and significant to manufacturers, importers, and proc- new uses subject to reporting. (1) The fol- essors of this substance, as specified in lowing chemical substance referred to § 721.125 (a), (b), (c) through (i), and (k). by its premanufacture notice number (2) Limitations or revocation of certain and generic chemical name is subject notification requirements. The provisions to reporting under this section for the of § 721.185 apply to this significant new significant new uses described in para- use rule. graph (a)(2) of this section: Derivative (3) Determining whether a specific use is of tetrachloroethylene, P-82–684. subject to this section. The provisions of (2) The significant new uses are: (i) § 721.1725(b)(1) apply to this section. Manufacture or processing without re- [55 FR 39900, Sept. 28, 1990. Redesignated and quiring use of the following by persons amended at 58 FR 29946, May 24, 1993; 58 FR employed by or under the control of 34204, June 23, 1993] the manufacturer or processor who are involved in, and in the immediate area § 721.3550 Dipropylene glycol dimethyl of, any operation where dermal contact ether. and/or inhalation of the substance may (a) Chemical substances and significant occur: new uses subject to reporting. (1) The (A) A respirator, approved by the Na- chemical substance identified as tional Institute for Occupational Safe- dipropylene glycol dimethyl ether ty (NIOSH) to provide protection (PMN P-93–507; CAS No. 111109–77–4) is against dusts having an air contamina- subject to reporting under this section tion level not less than 0.05 mg per for the significant new uses described cubic meter of air and fitted according in paragraph (a)(2) of this section. This to procedures established by the Occu- class 2 substance is exempt from the pational Safety and Health Adminis- notification requirements of this rule tration and Mine Safety and Health if it contains less than 5 percent by Administration regulations and set

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forth at 29 CFR 1910.134, and 30 CFR (2) [Reserved] part 11, respectively, and (Secs. 5, 8, Pub. L. 94–469, 90 Stat. 2012 (15 (B) Gloves which are determined to U.S.C. 2604, 2607)) be impervious to the substance under [49 FR 42932, Oct. 25, 1984. Redesignated at 53 the conditions of potential exposure FR 2845, Feb. 2, 1988. Further redesignated at (gloves must be determined to be im- 58 FR 29947, May 24, 1993] pervious to the substance either by testing the gloves under the conditions § 721.3565 Ethylenediamine, sub- of exposure, including the duration of stituted, sodium salt. exposure, or by evaluating the data and (a) Chemical substance and significant specifications supplied by the glove new uses subject to reporting. (1) The manufacturer or others, in the context chemical substance identified generi- of the conditions of exposure including cally as ethylenediamine, substituted, the duration of exposure, associated sodium salt (PMN P-97–328) is subject chemical substances, chemical and me- to reporting under this section for the chanical stresses, and potential dura- significant new uses described in para- tions of exposures. graph (a)(2) of this section. (ii) Manufacture or processing with- (2) The significant new uses are: out requiring that any container of the (i) Industrial, commercial, and con- substance or of a formulation consumer activities. Requirements as specified in § 721.80(g). taining the substance be: (ii) [Reserved] (A) Packaged to prevent any leakage (b) Specific requirements. The provi- of the substance to the environment. sions of subpart A of this part apply to (B) Labeled on the package that the this section except as modified by this substance should be handled only while paragraph. using NIOSH approved respirators and (1) Recordkeeping. Recordkeeping re- impervious gloves. quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), and (i) are applicable to manu- sions of subpart A of this part apply to facturers, importers, and processors of this section except as modified by this this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. In addition to the notification requirements. The provisions requirements of § 721.17, manufacturers of § 721.185 apply to this section. and processors of the substance identi- [63 FR 3427, Jan. 22, 1998] fied in paragraph (a)(1) of this section must maintain the following records § 721.3620 Fatty acid amine conden- for five years from the date of their sate, polycarboxylic acid salts. creation: (a) Chemical substance and significant (i) The names of persons required to new uses subject to reporting. (1) The wear protective equipment in accord- chemical substance identified as a ance with paragraph (a)(2) of this sec- fatty acid amine condensate, tion. polycarboxylic acid salts. (PMN P-92– (ii) The names and addresses of any 445) is subject to reporting under this person to whom the substance is sold section for the significant new uses de- or transferred and the dates of such scribed in paragraph (a)(2) of this sec- sale or transfer. tion. (2) The significant new uses are: (iii) Records of respirator fit tests for (i) Release to water. Requirements as each person required to wear a res- specified in § 721.90 (a)(1), (b)(1), and pirator in accordance with paragraph (c)(1). (a)(2) of this section. (ii) [Reserved] (iv) The method for determining that (b) Specific requirements. The provi- the gloves described in paragraph (a)(2) sions of subpart A of this part apply to of this section are impervious to the this section except as modified by this substance, the date(s) of such deter- paragraph. mination, and the results of that deter- (1) Recordkeeping requirements. Re- mination. quirements as specified in § 721.125 (a),

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(b), (c), and (i) are applicable to manu- porting under this section for the sig- facturers, importers, and processors of nificant new uses described in para- this substance. graph (a)(2) of this section. (2) Limitations or revocation of certain (2) The significant new uses are: notification requirements. The provisions (i) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as specified in § 721.80 (f), (g), and (l). [57 FR 46466, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993] (ii) [Reserved] (b) Specific requirements. The provi- § 721.3625 Fatty acid amine salt (ge- sions of subpart A of this part apply to neric name). this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping requirements. Rec- chemical substance identified generi- ordkeeping requirements specified in cally as fatty acid amine salt (PMN P- § 721.125 (a), (b), (c), and (i) are applica- 88–1889) is subject to reporting under ble to manufacturers, importers, and this section for the significant new processors of this substance. uses described in paragraph (a)(2) of (2) Limitations or revocation of certain this section. notification requirements. The provisions (2) The significant new uses are: of § 721.185 apply to this section. (i) Hazard communication program. Re- [60 FR 11043, Mar. 1, 1995] quirements as specified in § 721.72 (b)(2), (c), (f), and (g)(3)(ii). The provisions of § 721.3629 Triethanolamine salts of § 721.72(g) would require the following fatty acids. warning language on the label: Mini- (a) Chemical substances and significant mize releases to the environment. new uses subject to reporting. (1) The (ii) Industrial, commercial, and con- chemical substances identified generi- sumer activities. Requirements as speci- cally as triethanolamine salts of fatty fied in § 721.80 (k) and (q). acids (PMN Nos. P-92–156, P-92–157, and (iii) Release to water. Requirements as P-92–159) are subject to reporting under specified in § 721.90(a)(1). this section for the significant new (b) Specific requirements. The provi- uses described in paragraph (a)(2) of sions of subpart A of this part apply to this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Hazard communication program. A (1) Recordkeeping. The following rec- significant new use of these substances ordkeeping requirements are applicable is any manner or method of manufac- to manufacturers, importers, and proc- ture, import, or processing associated essors of this substance, as specified in with any use of these substances with- § 721.125 (a), (b), (c), (f), (g), (h), (i), and out providing risk notification as fol- (k). lows: (2) Limitations or revocation of certain (A) If as a result of the test data re- notification requirements. The provisions quired under the section 5(e) consent of § 721.185 apply to this significant new order for these substances, the em- use rule. ployer becomes aware that these sub- (3) Determining whether a specific use is stances may present a risk of injury to subject to this section. The provisions of human health, the employer must in- § 721.1725(b)(1) apply to this section. corporate this new information, and [55 FR 33305, Aug. 15, 1990. Redesignated and any information on methods for pro- amended at 58 FR 29946, May 24, 1993; 58 FR tecting against such risk, into an 34204, June 23, 1993] MSDS as described in § 721.72(c) within 90 days from the time the employer be- § 721.3627 Branched synthetic fatty comes aware of the new information. If acid. these substances are not being manu- (a) Chemical substance and significant factured, imported, processed, or used new uses subject to reporting. (1) The in the employer’s workplace, the em- chemical substance identified generi- ployer must add the new information cally as a branched synthetic fatty to an MSDS before the substances are acid (PMN P-94–422) is subject to re- reintroduced into the workplace.

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(B) The employer must ensure that (ii) Industrial, commercial, and con- persons who will receive, or who have sumer activities. Requirements as speci- received these substances from the em- fied in § 721.80(p) (15 months). ployer within 5 years from the date the (iii) Release to water. Requirements as employer becomes aware of the new in- specified in § 721.90 (a)(4), (b)(4), and formation described in paragraph (c)(4) (N = 6). (a)(2)(i)(A) of this section, are provided (b) Specific requirements. The provi- an MSDS as described in § 721.72(c) con- sions of subpart A of this part apply to taining the information required under this section except as modified by this paragraph (a)(2)(i)(A) of this section paragraph. within 90 days from the time the em- (1) Recordkeeping. Recordkeeping re- ployer becomes aware of the new infor- quirements as specified in § 721.125 (a), mation. (b), (c), (f), (g), (h), (i), and (k) are ap- (ii) Industrial, commercial, and con- plicable to manufacturers, importers, sumer activities. Requirements as speci- and processors of this substance. fied in § 721.80(q). (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this [63 FR 44578, Aug. 20, 1998] paragraph. (1) Recordkeeping. Recordkeeping re- § 721.3680 Ethylene oxide adduct of quirements as specified in § 721.125 (a), fatty acid ester with pentaeryth- (h), and (i) are applicable to manufac- ritol. turers, importers, and processors of (a) Chemical substance and significant these substances. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified generi- notification requirements. The provisions cally as ethylene oxide adduct of fatty of § 721.185 apply to this significant new acid ester with pentaerythritol (PMN use rule. P-91–442) is subject to reporting under (3) Determining whether a specific use is this section for the significant new subject to this section. The provisions of uses described in paragraph (a)(2) of § 721.1725(b)(1) apply to this section. this section. [58 FR 32238, June 8, 1993, as amended at 58 (2) The significant new uses are: FR 29946, May 24, 1993] (i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and § 721.3635 Octadecanoic acid, ester (c)(1). with 1,2-propanediol, phosphate, (ii) [Reserved] anhydride with silicic acid (H4SiO4). (b) Specific requirements. The provi- (a) Chemical substance and significant sions of subpart A of this part apply to new uses subject to reporting. (1) The this section except as modified by this chemical substance identified as octa- paragraph. decanoic acid, ester with 1,2- (1) Recordkeeping requirements. Re- propanediol, phosphate, anhydride with quirements as specified in § 721.125 (a), silicic acid (H4SiO4) (PMN P-96–1520; (b), (c), and (k) are applicable to manu- CAS No. 177771–31–2) is subject to re- facturers, importers, and processors of porting under this section for the sig- this substance. nificant new uses described in para- (2) Limitations or revocation of certain graph (a)(2) of this section. notification requirements. The provisions (2) The significant new uses are: of § 721.185 apply to this section. (i) Hazard communication program. Re- [57 FR 46466, Oct. 8, 1992, as amended at 58 FR quirements as specified in § 721.72 (a), 34204, June 23, 1993] (b), (c), (d), (f), (g)(3)(ii), (g)(4)(i), and (g)(5). The following statement shall § 721.3700 Fatty acid, ester with appear on each label as specified in styrenated phenol, ethylene oxide § 721.72(b) and the MSDS as specified in adduct. § 721.72(c): Do not release into the envi- (a) Chemical substances and significant ronment in quantities that allow sur- new uses subject to reporting. (1) The face water concentrations to exceed 6 chemical substance identified generi- ppb. cally as fatty acid, ester with

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styrenated phenol, ethylene oxide § 721.3720 Fatty amide. adduct (P-90–364) is subject to reporting (a) Chemical substance and significant under this section for the significant new uses described in paragraph (a)(2) new uses subject to reporting. (1) The of this section. chemical substance identified generi- (2) The significant new uses are: cally as a fatty amide (PMN P-91–87) is (i) Hazard communication program. Re- subject to reporting under this section quirements as specified in § 721.72 (a), for the significant new uses described (b), (c), (d), (f), (g)(3)(ii), and (g)(5). in paragraph (a)(2) of this section. (ii) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(4), (b)(4), and (i) Release to water. Requirements as (c)(4) (where N = 400 ppb). specified in § 721.90 (a)(1), (b)(1), and (b) Specific requirements. The provi- (c)(1). sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping requirements. Re- this section except as modified by this quirements as specified in § 721.125 (a), paragraph. (b), (c), (f), (g), (h), (i), and (k) are ap- (1) Recordkeeping requirements. Re- plicable to manufacturers, importers, quirements as specified in § 721.125 (a), and processors of this substance. (b), (c), and (k) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain [57 FR 44065, Sept. 23, 1992, as amended at 58 notification requirements. The provisions FR 34204, June 23, 1993] of § 721.185 apply to this section.

§ 721.3710 Polyether modified fatty [57 FR 46466, Oct. 8, 1992, as amended at 58 FR acids (generic). 34204, June 23, 1993] (a) Chemical substance and significant § 721.3740 Bisalkylated fatty alkyl new uses subject to reporting. (1) The amine oxide. chemical substance identified generically as a Polyether modified fatty (a) Chemical substance and significant acids (PMN P-99–0435) is subject to renew uses subject to reporting. (1) The porting under this section for the sig- chemical substance identified generi- nificant new use described in paragraph cally as bisalkylated fatty alkyl amine (a)(2) of this section. oxide (PMN P-90–643) is subject to re- (2) The significant new uses are: porting under this section for the sig- (i) Industrial, commercial, and con- nificant new use described in paragraph sumer activities. Requirements as speci- (a)(2) of this section. fied in § 721.80(j). (2) The significant new use is: (ii) [Reserved] (i) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(4), (b)(4), and sions of subpart A of this part apply to (c)(4) (concentration set at 80 ppb). this section except as modified by this (ii) [Reserved]. paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), and (i) are applicable to manu- paragraph. facturers, importers, and processors of (1) Recordkeeping. The following rec- this substance. ordkeeping requirements are applicable (2) Limitations or revocation of certain to manufacturers, importers, and proc- notification requirements. The provisions essors of this substance, as specified in of § 721.185 apply to this section. § 721.125 (a), (b), and (c). (3) Determining whether a specific use is (2) Limitations or revocation of certain subject to this section. The provisions of notification requirements. The provisions § 721.1725(b)(1) apply to this section. of § 721.185 apply to this significant new [65 FR 81399, Dec. 26, 2000] use rule.

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(3) Determining whether a specific use is (ii) Hazard communication program. subject to this section. The provisions of Requirements as specified in § 721.72 (a), § 721.1725(b)(1) apply to this section. (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(iv), (g)(2)(i), [56 FR 19238, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, 29947, May 24, 1993; 58 (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), FR 34204, June 23, 1993] (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5) during manufacture. § 721.3760 Fluorene-containing (iii) Industrial, commercial, and con- diaromatic amines. sumer activities. Requirements as speci- (a) Chemical substances and significant fied in § 721.80(l). new uses subject to reporting. (1) The (iv) Release to water. Requirements as chemical substances identified generi- specified in § 721.90 (a)(1), (b)(1), and cally as fluorene-containing (c)(1). diaromatic amines (PMN P-88–998 and (b) Specific requirements. The provi- P-88–999) are subject to reporting under sions of subpart A of this part apply to this section for the significant new this section except as modified by this uses described in paragraph (a)(2) of paragraph. this section. (1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a) (i) Release to water. Requirements as through (i) and (k) are applicable to specified in § 721.90 (a)(4), (b)(4), and manufacturers, importers, and proc- (c)(4) (where n = 1). essors of this substance. (ii) [Reserved] (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this [62 FR 42692, Aug. 8, 1997] paragraph. (1) Recordkeeping. Recordkeeping re- § 721.3780 Substituted and quirements as specified in § 721.125 (a), disubstituted tetrafluoro alkenes (b), (c), and (k) are applicable to manu- (generic). facturers, importers, and processors of (a) Chemical substances and significant this substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified generi- notification requirements. The provisions cally as substituted and disubstituted of § 721.185 apply to this section. tetrafluoro alkene (PMN P-84–105) is [60 FR 45082, Aug. 30, 1995] subject to reporting under this section for the significant new uses described § 721.3764 Fluorene substituted aro- in paragraph (a)(1)(i) of this section. matic amine. (i) The significant new uses are: (a) Chemical substance and significant (A) Protection in the workplace. Re- new uses subject to reporting. (1) The quirements as specified in § 721.63 (a)(1), chemical substance identified generi- (a)(3), (a)(4), (a)(5)(i), (a)(6)(v), (a)(6)(vi), cally as a fluorene substituted aro- (b) (concentration set at 1%), and (c). matic amine (PMN P-91–43) is subject (B) Hazard communication program. to reporting under this section for the Requirements as specified in § 721.72 (a), significant new uses described in para- (b)(2), (d), (e) (concentration set at 1%), graph (a)(2) of this section. (f), (g)(1)(i), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), (2) The significant new uses are: (g)(2)(iv), and (g)(2)(v). In addition, the (i) Protection in the workplace. Re- precautionary statements described quirements as specified in § 721.63 (a)(1), under § 721.72(g) shall include: This sub- (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), stance may cause eye irritation. (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(6)(i), (C) Industrial, commercial, and con- (b) (concentration set at 1.0 percent), sumer activities. Requirements as speci- and (c). However, these requirements fied in § 721.80(g). do not apply after the PMN substance (ii) Specific requirements. The provi- is adhered onto film or incorporated sions of subpart A of this part apply to into prepreg form (resin impregnated this section except as modified by this substrate). paragraph.

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(A) Recordkeeping. The following rec- precautionary statements described ordkeeping requirements are applicable under § 721.72(g) shall include: This sub- to manufacturers, importers, and proc- stance may cause eye irritation. essors of this substance: § 721.125 (a) (C) Industrial, commercial, and con- through (g) and (i). sumer activities. Requirements as speci- (B) Limitations or revocation of certain fied in § 721.80(g). notification requirements. The provisions (ii) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to (2) The chemical substance identified this section except as modified by this generically as disubstituted tetrafluoro paragraph. alkene (PMN P-84–106) is subject to re- (A) Recordkeeping. The following rec- porting under this section for the sig- ordkeeping requirements are applicable nificant new uses described in para- to manufacturers, importers, and proc- graph (a)(2)(i) of this section. essors of this substance: § 721.125 (a) (i) The significant new uses are: through (g) and (i). (A) Protection in the workplace. Re- (B) Limitations or revocation of certain quirements as specified in § 721.63 (a)(1), notification requirements. The provisions (a)(3), (a)(4), (a)(5)(i), (a)(6)(v), (a)(6)(vi), of § 721.185 apply to this section. (b) (concentration set at 1%), and (c). [67 FR 17649, Apr. 11, 2002] (B) Hazard communication program. Requirements as specified in § 721.72 (a), § 721.3790 Polyfluorocarboxylates. (b)(2), (d), (e) (concentration set at 1%), (a) Chemical substances and significant (f), (g)(1)(i), (g)(1)(iv), (g)(1)(v), (g)(2)(i), new uses subject to reporting. (1) The (g)(2)(ii), (g)(2)(iv), and (g)(2)(v). In ad- chemical substances identified generi- dition, the precautionary statements cally as polyfluorocarboxylates (PMNs described under § 721.72(g) shall include: P-94–322 and P-94–323) are subject to re- This substance may cause eye irrita- porting under this section for the sig- tion. nificant new uses described in para- (C) Industrial, commercial, and con- graph (a)(2) of this section. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80(g). (i) Industrial, commercial, and con- (ii) Specific requirements. The provi- sumer activities. Requirements as speci- sions of Subpart A of this part apply to fied in § 721.80(g). this section except as modified by this (ii) Release to water. Requirements as paragraph. specified in § 721.90 (a)(1), (b)(1), and (A) Recordkeeping. The following rec- (c)(1). ordkeeping requirements are applicable (b) Specific requirements. The provi- to manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance: § 721.125 (a) this section except as modified by this through (g) and (i). paragraph. (B) Limitations or revocation of certain (1) Recordkeeping requirements. Rec- notification requirements. The provisions ordkeeping requirements specified in of § 721.185 apply to this section. § 721.125 (a), (b), (c), (i), and (k) are ap- (3) The chemical substance identified plicable to manufacturers, importers, generically as disubstituted tetrafluoro and processors of this substance. alkene (PMN P-84–107) is subject to re- (2) Limitations or revocation of certain porting under this section for the sig- notification requirements. The provisions nificant new uses described in para- of § 721.185 apply to this section. graph (a)(3)(i) of this section. [60 FR 11043, Mar. 1, 1995] (i) The significant new uses are: (A) Protection in the workplace. Re- § 721.3800 Formaldehyde, condensated quirements as specified in § 721.63 (a)(1), polyoxyethylene fatty acid, ester (a)(3), (a)(4), (a)(5)(i), (a)(6)(v), (a)(6)(vi), with styrenated phenol, ethylene (b) (concentration set at 1%), and (c). oxide adduct. (B) Hazard communication program. (a) Chemical substances and significant Requirements as specified in § 721.72 (a), new uses subject to reporting. (1) The (b)(2), (d), (e) (concentration set at 1%), chemical substance identified generi- (f), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), cally as formaldehyde, condensated (g)(2)(iv), and (g)(2)(v). In addition, the polyoxyethylene fatty acid, ester with

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styrenated phenol, ethylene oxide § 721.3807 Formaldehyde, polymer adduct (PMN P-90–360) is subject to re- with phenol and 1,2,3-propanetriol, porting under this section for the sig- methylated. nificant new uses described in para- (a) Chemical substance and significant graph (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified as form- (i) Hazard communication program. Re- aldehyde, polymer with phenol and quirements as specified in § 721.72 (a), 1,2,3-propanetriol, methylated (PMN P- (b), (c), (d), (f), (g)(3)(ii), and (g)(5). 99–0044; CAS No. 209810–57–1) is subject (ii) Release to water. Requirements as to reporting under this section for the specified in § 721.90 (a)(4), (b)(4) and significant new use described in para- (c)(4) (where N = 400 ppb). graph (a)(2) of this section. (b) The provi- Specific requirements. (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified in § 721.90 (a)(4), (b)(4), and paragraph. (c)(4) (N=3 ppb). (1) Recordkeeping requirements. Re- quirements as specified in § 721.125 (a), (ii) [Reserved] (b), (c), (f), (g), (h), (i), and (k) are ap- (b) Specific requirements. The provi- plicable to manufacturers, importers, sions of subpart A of this part apply to and processors of this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- [57 FR 44066, Sept. 23, 1992, as amended at 58 facturers, importers, and processors of FR 34204, June 23, 1993] this substance. § 721.3805 Formaldehyde, reaction (2) Limitations or revocation of certain products with 1,3- notification requirements. The provisions benzenedimethanamine and of § 721.185 apply to this section. bisphenol A. [68 FR 15084, Mar. 28, 2003] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.3810 Formaldehyde, polymers chemical substance identified as form- with substituted phenols (generic). aldehyde, reaction products with 1,3- (a) Chemical substance and significant benzenedimethanamine and bisphenol new uses subject to reporting. (1) The A (PMN P-00–0738; CAS No. 259871–68–6) chemical substance identified generi- is subject to reporting under this sec- cally as Formaldehyde, polymers with tion for the significant new use de- substituted phenols (PMN P-99–0558) is scribed in paragraph (a)(2) of this sec- subject to reporting under this section tion. for the significant new use described in (2) The significant new uses are: paragraph (a)(2) of this section. (i) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(1), (b)(1), and (i) Industrial, commercial, and con- (c)(1). sumer activities. Requirements as speci- (ii) [Reserved] fied in § 721.80(j). (b) Specific requirements. The provi- (ii) [Reserved] sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), and (k) are applicable to manu- quirements as specified in § 721.125 (a), facturers, importers, and processors of (b), (c), and (i) are applicable to manu- this substance. facturers, importers, and processors of (2) Limitations or revocation of certain this substance. notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions [68 FR 15084, Mar. 28, 2003] of § 721.185 apply to this section.

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(3) Determining whether a specific use is health or the environment, the em- subject to this section. The provisions of ployer must incorporate this new infor- § 721.1725(b)(1) apply to this section. mation, and any information on meth- [65 FR 81400, Dec. 26, 2000] ods for protecting against such risk, into a Material Safety Data Sheet § 721.3812 Substituted phenols and (MSDS) as described in § 721.72(c) with- formaldehyde polymer, alkylated in 90 days from the time the employer (generic). becomes aware of the new information. (a) Chemical substance and significant If this substance is not being manufac- new uses subject to reporting. (1) The tured, imported, processed, or used in chemical substance identified generi- the employer’s workplace, the em- cally as substituted phenols and form- ployer must add the new information aldehyde polymer, alkylated (PMN P- to an MSDS before the substance is re- 00–0542) is subject to reporting under introduced into the workplace. this section for the significant new use (B) The employer must ensure that described in paragraph (a)(2) of this persons who will receive, or who have section. received this substance from the em- (2) The significant new uses are: ployer within 5 years from the date the (i) Industrial, commercial, and con- employer becomes aware of the new in- sumer activities. Requirements as speci- formation described in paragraph fied in § 721.80(j) (a resin for can and (a)(2)(i)(A) of this section, are provided tube coatings). an MSDS as described in § 721.72(c) con- (ii) [Reserved] taining the information required under (b) Specific requirements. The provi- paragraph (a)(2)(i)(A) of this section sions of subpart A of this part apply to within 90 days from the time the em- this section except as modified by this ployer becomes aware of the new infor- paragraph. mation. (1) Recordkeeping. Recordkeeping re- (ii) Industrial, commercial, and con- quirements as specified in § 721.125 (a), sumer activities. Requirements as speci- (b), (c), and (i) are applicable to manu- fied in § 721.80(q). facturers, importers, and processors of (b) Specific requirements. The provi- this substance. sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this section. (1) Recordkeeping requirements. Rec- [68 FR 15084, Mar. 28, 2003] ordkeeping requirements as specified in § 721.125 (a), (h), and (i) are applicable § 721.3815 Furan, 2-(ethoxymethyl)- to manufacturers, importers, and proc- tetrahydro-. essors of this substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance furan, 2- of § 721.185 apply to this section. (ethoxymethyl) tetrahydro- (P-93–721) (3) Determining whether a specific use is is subject to reporting under this sec- subject to this section. The provisions of tion for the significant new uses de- § 721.1725(b)(1) apply to this section. scribed in paragraph (a)(2) of this section. [60 FR 11043, Mar. 1, 1995] (2) The significant new uses are: (i) Hazard communication program. A § 721.3818 Furan, octafluorotetrahydro-. significant new use of this substance is any manner or method of manufacture, (a) Chemical substance and significant import, or processing associated with new uses subject to reporting. (1) The any use of this substance without pro- chemical substance identified as furan, viding risk notification as follows: octafluorotetrahydro- (PMN P-99–0965; (A) If, as a result of the test data re- CAS No. 773–14–8) is subject to report- quired under the section 5(e) consent ing under this section for the signifi- order for this substance, the employer cant new use described in paragraph becomes aware that this substance (a)(2) of this section. may present a risk of injury to human (2) The significant new uses are:

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(i) Industrial, commercial, and con- reporting under this section for the sig- sumer activities. Requirements as speci- nificant new use described in paragraph fied in § 721.80(j) (a heat transfer agent). (a)(2) of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Requirements as speci- this section except as modified by this fied in § 721.80(j). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), and (i) are applicable to manu- this section except as modified by this facturers, importers, and processors of paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (i) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of this substance. [68 FR 15084, Mar. 28, 2003] (2) Limitations or revocation of certain § 721.3820 L-Glutamic acid, N-(1- notification requirements. The provisions oxododecyl)-, disodium salt. of § 721.185 apply to this section. (a) Chemical substance and significant (3) Determining whether a specific use is new uses subject to reporting. (1) The subject to this section. The provisions of chemical substance identified as L-Glu- § 721.1725(b)(1) apply to this section. tamic acid, N-(1-oxododecyl)-, disodium [65 FR 81400, Dec. 26, 2000] salt (PMN P-99–0207; CAS No. 50622–20– 3) is subject to reporting under this § 721.3830 Formaldehyde, reaction section for the significant new use de- products with an alkylated phenol scribed in paragraph (a)(2) of this sec- and an aliphatic amine (generic). tion. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Industrial, commercial, and con- chemical substance identified generi- sumer activities. Requirements as speci- cally as Formaldehyde, reaction prod- fied in § 721.80(j). ucts with an alkylated phenol and an (ii) [Reserved] aliphatic amine (PMN P-99–0531) is sub- (b) Specific requirements. The provi- ject to reporting under this section for sions of subpart A of this part apply to the significant new use described in this section except as modified by this paragraph (a)(2) of this section. paragraph. (2) The significant new uses are: (1) Recordkeeping. Recordkeeping re- (i) Industrial, commercial, and con- quirements as specified in § 721.125 (a), sumer activities. Requirements as speci- (b), (c), and (i) are applicable to manu- fied in § 721.80(j). facturers, importers, and processors of (ii) [Reserved] this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. (3) Determining whether a specific use is (1) Recordkeeping. Recordkeeping re- subject to this section. The provisions of quirements as specified in § 721.125 (a), § 721.1725(b)(1) apply to this section. (b), (c), and (i) are applicable to manufacturers, importers, and processors of [65 FR 81400, Dec. 26, 2000] this substance. § 721.3821 L-Glutamic acid, N-(1- (2) Limitations or revocation of certain oxododecyl)-. notification requirements. The provisions of § 721.185 apply to this section. (a) Chemical substance and significant (3) Determining whether a specific use is new uses subject to reporting. (1) The subject to this section. The provisions of chemical substance identified as L-Glu- § 721.1725(b)(1) apply to this section. tamic acid, N-(1-oxododecyl)- (PMN P- 99–0208; CAS No. 3397–65–7) is subject to [65 FR 81400, Dec. 26, 2000]

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§ 721.3835 Chloroformate (generic). (iii) Industrial, commercial, and consumer activities. Requirements as speci- (a) Chemical substance and significant fied in § 721.80 (o). new uses subject to reporting. (1) The (iv) Disposal. Requirements as speci- chemical substance identified generi- fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2) cally as a chloroformate (PMN P-01–1) and (c)(1), (c)(2). is subject to reporting under this sec- (v) Release to water. Requirements as tion for the significant new use de- specified in § 721.90 (a)(2)(vi), (b)(2)(vi) scribed in paragraph (a)(2) of this sec- and (c)(2)(vi). tion. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Releases to water. Requirements as this section except as modified by this specified in § 721.90(a)(4), (b)(4), and paragraph. (c)(4) (N=2). (1) Recordkeeping. The following rec- (ii) [Reserved] ordkeeping requirements are applicable (b) Specific requirements. The provi- to manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance, as specified in this section except as modified by this § 721.125 (a) through (k). paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125(a), of § 721.185 apply to this significant new use rule. (b), (c), and (k) are applicable to manufacturers, importers, and processors of [55 FR 26101, June 26, 1990. Redesignated at 58 this chemical substance. FR 29947, May 24, 1993, as amended at 58 FR (2) Limitations or revocation of certain 34204, June 23, 1993] notification requirements. The provisions § 721.3845 Alkyl substituted aromatic of § 721.185 apply to this section. glycidyl ether (generic). [68 FR 70177, Dec. 17, 2003] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.3840 Tetraglycidalamines (ge- chemical substance identified generi- neric name). cally as alkyl substituted aromatic (a) Chemical substance and significant glycidyl ether (PMN P-97–661) is sub- new uses subject to reporting. (1) The ject to reporting under this section for chemical substances identified generi- the significant new use described in cally as tetraglycidalamines (PMN P- paragraph (a)(2) of this section. 86–500 and P-86–502) are subject to re- (2) The significant new uses are: porting under this section for the sig- (i) Protection in the workplace. Re- nificant new uses described in para- quirements as specified in § 721.63 (a)(1) graph (a)(2) of this section. and (a)(3). (2) The significant new uses are: (ii) Hazard communication program. Requirements as specified in § 721.72 (a), (i) Protection in the workplace. Re- (b), (c), (d), (e) (concentration set at 0.1 quirements as specified in § 721.63 (a)(1), percent), (f), (g)(1)(i), (g)(1)(iv), (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), (a)(5) (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), (vi), (a)(6)(i), (a)(5)(xi) and (a)(6)(ii), (b) (g)(2)(v), (g) (4) (iii), and (g)(5). (concentration set at 0.1 percent), and (iii) Industrial, commercial, and con- (c). The respirator required under sumer activities. Requirements as speci- § 721.63 (a)(5)(vi) is applicable only when fied in § 721.80(q). the PMN substance is in the form of a (iv) Release to water. Requirements as dust. The respirator required under specified in § 721.90 (a)(1), (b)(1), and § 721.63 (a)(5)(xi) is applicable only when (c)(1). the PMN substance is in the form of a (b) Specific requirements. The provi- mist. sions of subpart A of this part apply to (ii) Hazard communication program. this section except as modified by this Requirements as specified in § 721.72 (a), paragraph. (b)(2), (c), (d), (e) (concentration set at (1) Recordkeeping. Recordkeeping re- 0.1 percent), (f), (g)(1)(vii), (g)(2)(i), quirements as specified in § 721.125 (a), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5). (b), (c),(d),(e), (f), (g), (h),(i), and (k) are

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applicable to manufacturers, import- order for this substance, the employer ers, and processors of this substance. becomes aware that this substance (2) Limitations or revocation of certain may present a risk of injury to human notification requirements. The provisions health, the employer must incorporate of § 721.185 apply to this section. this new information, and any informa- (3) Determining whether a specific use is tion on methods for protecting against subject to this section. The provisions of such risk, into an MSDS as described § 721.1725(b)(1) apply to this section. in § 721.72(c) within 90 days from the time the employer becomes aware of [65 FR 369, Jan. 5, 2000] the new information. If this substance § 721.3848 Glycine, N-(carboxymethyl)- is not being manufactured, imported, N-dodecyl-, monosodium salt. processed, or used in the employer’s workplace, the employer must add the (a) Chemical substance and significant new information to an MSDS before new uses subject to reporting. (1) The chemical substance identified as gly- the substance is reintroduced into the workplace. cine, N-(carboxymethyl)-N-dodecyl-, (B) The employer must ensure that monosodium salt (PMN P-00–469; CAS persons who have received, or will re- No. 141321–68–8) is subject to reporting ceive, this substance from the em- under this section for the significant ployer are provided an MSDS as de- new use described in paragraph (a)(2) of scribed in § 721.72(c) containing the in- this section. formation required under paragraph (2) The significant new uses are: (a)(2)(i)(A) within 90 days from the (i) Release to water. Requirements as time the employer becomes aware of specified in § 721.90 (a)(4), (b)(4), (c)(4) the new information. (N=30 ppb). (ii) Industrial, commercial, and con- (ii) [Reserved] sumer activities. Requirements as speci- (b) Specific requirements. The provi- fied in § 721.80(q). sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. The following rec- (b), (c), and (k) are applicable to manu- ordkeeping requirements are applicable facturers, importers, and processors of to manufacturers, importers, and proc- this substance. essors of this substance, as specified in (2) Limitations or revocation of certain § 721.125 (a), (h), and (i). notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions [68 FR 15084, Mar. 28, 2003] of § 721.185 apply to this significant new use rule. § 721.3860 Glycol monobenzoate. (3) Determining whether a specific use is (a) Chemical substance and significant subject to this section. The provisions of new uses subject to reporting. (1) The § 721.1725(b)(1) apply to this section. chemical substance identified as ge- [56 FR 40211, Aug. 13, 1991, as amended at 56 nerically as glycol monobenzoate (P- FR 46729, Sept. 16, 1991. Redesignated and 90–1357) is subject to reporting under amended at 58 FR 29946, May 24, 1993; 58 FR this section for the significant new 34204, June 23, 1993] uses described in paragraph (a)(2) of this section. § 721.3880 Polyalkylene glycol sub- (2) The significant new uses are: stituted acetate. (i) Hazard communication program. A (a) Chemical substance and significant significant new use of this substance is new uses subject to reporting. (1) The any manner or method of manufacture, chemical substance identified generi- import, or processing associated with cally as polyalkylene glycol sub- any use of this substance without pro- stituted acetate (PMN P-91–1269) is sub- viding risk notification as follows: ject to reporting under this section for (A) If as a result of the test data re- the significant new uses described in quired under the section 5(e) consent paragraph (a)(2) of this section.

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(2) The significant new uses are: (3) Determining whether a specific use is (i) Hazard communication program. A subject to this section. The provisions of significant new use of this substance is § 721.1725(b)(1) apply to this section. any manner or method of manufacture, [57 FR 44066, Sept. 23, 1992, as amended at 58 import, or processing associated with FR 29946, May 24, 1993; 58 FR 34204, June 23, any use of this substance without pro- 1993] viding risk notification as follows: (A) If as a result of the test data re- § 721.3900 Alkyl polyethylene glycol quired under the section 5(e) consent phosphate, potassium salt. order for this substance, the employer (a) Chemical substances and significant becomes aware that this substance new uses subject to reporting. (1) The may present a risk of injury to the en- chemical substance identified generi- vironment, the employer must incor- cally as alkyl polyethylene glycol porate this new information, and any phosphate, potassium salt (P-90–481), is information on methods for protecting subject to reporting under this section against such risk, into an MSDS as de- for the significant new uses described scribed in § 721.72(c) within 90 days from in paragraph (a)(2) of this section. the time the employer becomes aware (2) The significant new uses are: of the new information. If this sub- (i) Hazard communication program. A stance is not being manufactured, im- significant new use of this substance is ported, processed, or used in the em- any manner or method of manufacture, ployer’s workplace, the employer must import, or processing associated with add the new information to an MSDS any use of this substance without pro- before the substance is reintroduced viding risk notification as follows. into the workplace. (A) If, as a result of the test data required under the section 5(e) consent (B) The employer must ensure that order for this substance, the employer persons who will receive this substance becomes aware that this substance from the employer, or who have re- may present a risk of injury to human ceived this substance from the em- health, the employer must incorporate ployer within 5 years from the date the this new information, and any informa- employer becomes aware of this new tion on methods for protecting against information described in paragraph such risk, into a Material Safety Data (a)(2)(i)(A) of this section, are provided Sheet (MSDS) as described in § 721.72(c) an MSDS as described in § 721.72(c) con- within 90 days from the time the em- taining the information required under ployer becomes aware of the new infor- paragraph (a)(2)(i)(A) of this section mation. If this substance is not being within 90 days from the time the em- manufactured, imported, processed, or ployer becomes aware of the new infor- used in the employer’s workplace, the mation. employer must add the new informa- (ii) Industrial, commercial, and con- tion to an MSDS before the substance sumer activities. Requirements as speci- is reintroduced into the workplace. fied in § 721.80(q). (B) The employer must ensure that (b) Specific requirements. The provi- persons who have received, or will re- sions of subpart A of this part apply to ceive, this substance from the em- this section except as modified by this ployer are provided an MSDS as de- paragraph. scribed in § 721.72(c) containing the information required under paragraph (1) Recordkeeping requirements. Re- (a)(2)(i)(A) of this section from the quirements as specified in § 721.125 (a), time the employer becomes aware of (h), and (i) are applicable to manufac- the new information. turers, importers, and processors of (ii) Industrial, commercial, and con- this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(q). notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to this section except as modified by this paragraph.

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(1) Recordkeeping requirements. The section for the significant new uses de- following recordkeeping requirements scribed in paragraph (a)(2) of this sec- are applicable to manufacturers, im- tion. porters, and processors of this sub- (2) The significant new uses are: stance, as specified in § 721.125 (a), (c), (i) Hazard communication program. A (h), and (i). significant new use of this substance is (2) Limitations or revocation of certain any manner or method of manufacture, notification requirements. The provisions import, or processing associated with of § 721.185 apply to this significant new any use of this substance without pro- use rule. viding risk notification as follows: (3) Determining whether a specific use is (A) If as a result of the test data re- subject to this section. The provisions of quired under the section 5(e) consent § 721.1725(b)(1) apply to this section. order for this substance, the employer [56 FR 15792, Apr. 17, 1991; 56 FR 29903, July becomes aware that this substance 1, 1991. Redesignated and amended at 58 FR may present a risk of injury to human 29946, 29947, May 24, 1993; 58 FR 34204, June 23, health or the environment, the em- 1993] ployer must incorporate this new information, and any information on meth- § 721.4000 Polyoxy alkylene glycol amine. ods for protecting against such risk, into an MSDS as described at § 721.72(c) (a) Chemical substance and significant within 90 days from the time the em- new uses subject to reporting. (1) The ployer becomes aware of the new infor- chemical substance identified generi- mation. If this substance is not being cally as polyoxy alkylene glycol amine manufactured, imported, processed, or (PMN P-91–1372) is subject to reporting used in the employer’s workplace, the under this section for the significant employer must add the new informa- new uses described in paragraph (a)(2) tion to an MSDS before the substance of this section. is reintroduced into the workplace. (2) The significant new uses are: (B) The employer must ensure that (i) Release to water. Requirements as persons who have received, or will re- specified at § 721.90 (a)(1), (b)(1), and ceive, this substance from the em- (c)(1). ployer are provided an MSDS as de- (ii) [Reserved] scribed in § 721.72(c) containing the in- (b) Specific requirements. The provi- formation required under paragraph sions of subpart A of this part apply to (a)(2)(i)(A) within 90 days from the this section except as modified by this time the employer becomes aware of paragraph. the new information. (1) Recordkeeping requirements. Rec- ordkeeping requirements as specified (ii) Industrial, commercial, and con- at § 721.125 (a), (b), (c), and (k) are appli- sumer activities. Requirements as speci- cable to manufacturers, importers, and fied in § 721.80(p) (volume set at 1,115,000 processors of this substance. kg). (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this paragraph. [57 FR 31968, July 20, 1992, as amended at 58 (1) Recordkeeping. The following rec- FR 34204, June 23, 1993] ordkeeping requirements are applicable § 721.4040 Glycols, polyethylene-, 3- to manufacturers, importers, and proc- sulfo-2-hydroxypropyl-p-(1,1,3,3- essors of this substance, as specified in tetramethylbutyl)phenyl ether, so- § 721.125 (a), (h), and (i). dium salt. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this significant new chemical substance identified as use rule. glycols, polyethylene-, 3-sulfo-2- [56 FR 40212, Aug. 13, 1991, as amended at 56 hydroxypropyl-p-(1,1,3,3-tetramethyl FR 46729, Sept. 16, 1991. Redesignated at 58 butyl)phenyl ether, sodium salt (P-90– FR 29946, May 24, 1993; 58 FR 34204, June 23, 1565) is subject to reporting under this 1993]

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§ 721.4060 Alkylene glycol terephtha- essors of this substance, as specified in late and substituted benzoate esters § 721.125 (a), (b), and (c). (generic name). (2) [Reserved] (a) Chemical substance and significant [58 FR 63517, Dec. 1, 1993] new uses subject to reporting. (1) The chemical substance identified generi- § 721.4085 Guanidine, pentaethyl-. cally as alkylene glycol terephthalate and substituted benzoate esters (PMN (a) Chemical substance and significant P-89–596) is subject to reporting under new uses subject to reporting. (1) The this section for the significant new chemical substance identified as guani- uses described in paragraph (a)(2) of dine, pentaethyl- (PMN P-94–1018; CAS this section. No. 13439–89–9) is subject to reporting (2) The significant new uses are: under this section for the significant (i) Industrial, commercial, and con- new uses described in paragraph (a)(2) sumer activities. Requirements as speci- of this section. fied in § 721.80(q) (2) The significant new uses are: (ii) [Reserved] (i) Protection in the workplace. Re- (b) Specific requirements. The provi- quirements as specified in § 721.63 (a)(1), sions of subpart A of this part apply to (a)(2)(i), and (a)(3). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. The following rec- sions of subpart A of this part apply to ordkeeping requirements are applicable this section except as modified by this to manufacturers, importers, and proc- paragraph. essors of this substance, as specified in (1) Recordkeeping. Recordkeeping re- § 721.125 (a), (b), (c) and (i). quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), (d), and (e) are applicable to notification requirements. The provisions manufacturers, importers, and proc- of § 721.185 apply to this significant new essors of this substance. use rule. (2) Limitations or revocation of certain (3) Determining whether a specific use is notification requirements. The provisions subject to this section. The provisions of of § 721.185 apply to this section. § 721.1725(b)(1) apply to this section. [63 FR 3427, Jan. 22, 1998] [55 FR 26101, June 26, 1990. Redesignated and amended at 58 FR 29946, 29947, May 24, 1993; 58 § 721.4090 Ethanaminium, N- FR 34204, June 23, 1993] [bis(diethylamino)-methylene]-N- ethyl-, bromide. § 721.4080 MNNG (N-methyl-N′-nitro-N- nitrosoguanidine). (a) Chemical substance and significant new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified as new use subject to reporting. (1) The ethanaminium, N-[bis(diethylamino)- chemical substance MNNG (N-methyl- methylene]-N-ethyl-, bromide (PMN P- N′-nitro-N-nitrosoguanidine) (CAS No. 94–1019; CAS No. 89610–32–2) is subject 70–25–7) is subject to reporting under this section for the significant new use to reporting under this section for the described in paragraph (a)(2) of this significant new uses described in para- section. graph (a)(2) of this section. (2) The significant new use is: Manu- (2) The significant new uses are: facture, import, or processing of 10,000 (i) Release to water. Requirements as pounds or more per year per facility for specified in § 721.90 (a)(1), (b)(1), and any use. (c)(1). (b) Specific requirements. The provi- (ii) [Reserved] sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. The following rec- paragraph. ordkeeping requirements are applicable (1) Recordkeeping. Recordkeeping re- to manufacturers, importers, and proc- quirements as specified in § 721.125 (a),

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(b), (c), and (k) are applicable to manu- (1) Recordkeeping. Recordkeeping re- facturers, importers, and processors of quirements as specified in § 721.125(a), this substance. (b), (c), and (i) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this chemical substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [63 FR 3427, Jan. 22, 1998] of § 721.185 apply to this section. § 721.4095 Quaternary ammonium [68 FR 70177, Dec. 17, 2003] alkyltherpropyl trialkylamine halides. § 721.4097 7-Oxabicyclo[4.1.0]heptane- (a) Chemical substance and significant 3-carboxylic acid, methyl ester. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substances identified generi- new uses subject to reporting. (1) The cally as quaternary ammonium chemical substance identified as 7- alkyltherpropyl trialkylamine halides oxabicyclo[4.1.0]heptane-3-carboxylic (PMNs P-96–1280/81/1504/1505/1506/1507/ acid, methyl ester (PMN P-98–101) is 1508) are subject to reporting under subject to reporting under this section this section for the significant new for the significant new uses described uses described in paragraph (a)(2) of in paragraph (a)(2) of this section. this section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial, and con- (i) Release to water. Requirements as sumer activities. Requirements as speci- specified in § 721.90 (a)(1), (b)(1), and fied in § 721.80(g). (c)(1). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. The recordkeeping (1) Recordkeeping. Recordkeeping re- requirements specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c) and (i) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. these substances. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [63 FR 44578, Aug. 20, 1998] [63 FR 3428, Jan. 22, 1998] § 721.4098 Substituted heteroaromatic- § 721.4096 Substituted anilino 2[[4-(dimethylamino) phenyl]azo]-3- halobenzamide (generic). methyl-, salts (generic). (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substances identified generically as substituted anilino cally as substituted heteroaromatic- halobenzamide (PMN P-99–1288) is sub- 2[[4-(dimethylamino)phenyl]azo]-3- ject to reporting under this section for methyl-, salts (PMNs P-97–582 and P-97– the significant new use described in 583) are subject to reporting under this paragraph (a)(1) of this section. section for the significant new uses de- (2) The significant new uses are: scribed in paragraph (a)(2) of this sec- (i) Industrial, commercial, and con- tion. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80(f). (i) Industrial, commercial, and con- (ii) [Reserved] sumer activities. Requirements as speci- (b) Specific requirements. The provi- fied in § 721.80(f). sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to

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this section except as modified by this (3) Determining whether a specific use is paragraph. subject to this section. The provisions of (1) Recordkeeping. Recordkeeping re- § 721.1725(b)(1) apply to this section. quirements as specified in § 721.125 (a), [56 FR 40212, Aug. 13, 1991. Redesignated and (b), (c), and (i) are applicable to manu- amended at 58 FR 29946, May 24, 1993; 58 FR facturers, importers, and processors of 34204, June 23, 1993] this substance. (2) Limitations or revocation of certain § 721.4105 Bicyclo[2.2.1]hept-2-ene, 5- notification requirements. The provisions butyl-. of § 721.185 apply to this section. (a) Chemical substance and significant [63 FR 44578, Aug. 20, 1998] new uses subject to reporting. (1) The chemical substance identified as § 721.4100 Tris(disubstituted alkyl) Bicyclo[2.2.1]hept-2-ene, 5-butyl- (PMN heterocycle. P-98–315; CAS No. 22094–81–1) is subject (a) Chemical substance and significant to reporting under this section for the new uses subject to reporting. (1) The significant new uses described in para- chemical substance identified generi- graph (a)(2) of this section. cally as tris(disubstituted alkyl) (2) The significant new uses are: heterocycle (P-90–142) is subject to re- (i) Release to water. Requirements as porting under this section for the sig- specified in § 721.90 (a)(1), (b)(1), and nificant new uses described in para- (c)(1). graph (a)(2) of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Protection in the workplace. Re- sions of subpart A of this part apply to quirements as specified in § 721.63 (a)(4), this section except as modified by this (a)(5)(iv), (a)(6)(i), (b) (concentration paragraph. set at 0.1 percent) and (c). (1) Recordkeeping. Recordkeeping re- (ii) Hazard communication program. quirements as specified in § 721.125 (a), Requirements as specified in § 721.72 (a), (b), (c), and (k) are applicable to manu- (b), (c), (d), (e) (concentration set at 0.1 facturers, importers, and processors of percent), (f), (g)(1)(iv), (g)(1)(vi), these substances. (g)(1)(vii), (g)(2)(iv), (g)(5). The hazard (2) Limitations or revocation of certain communication requirements do not notification requirements. The provisions apply when the chemical substance is of § 721.185 apply to this section. present in a plastic, an elastomer, a rubber matrix, or in a solution. [65 FR 369, Jan. 5, 2000] (iii) Industrial, commercial, and con- § 721.4106 Bicyclo[2.2.1]hept-2-ene, 5- sumer activities. Requirements as speci- hexyl-. fied in § 721.80(q). Any amount of the PMN substance imported in a plastic, (a) Chemical substance and significant an elastomer, a rubber matrix, or in a new uses subject to reporting. (1) The solution, such that inhalation is pre- chemical substance identified as cluded, shall not be included in the pro- Bicyclo[2.2.1]hept-2-ene, 5-hexyl- (PMN duction limit calculations. P-98–316; CAS No. 22094–83–3) is subject (b) Specific requirements. The provi- to reporting under this section for the sions of subpart A of this part apply to significant new uses described in para- this section except as modified by this graph (a)(2) of this section. paragraph. (2) The significant new uses are: (1) Recordkeeping. The following rec- (i) Release to water. Requirements as ordkeeping requirements are applicable specified in § 721.90 (a)(1), (b)(1), and to manufacturers, importers, and proc- (c)(1). essors of this substance, as specified in (ii) [Reserved] § 721.125 (a), (b), (c), (d), (f), (g), (h), and (b) Specific requirements. The provi- (i). sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this significant new (1) Recordkeeping. Recordkeeping reuse rule. quirements as specified in § 721.125 (a),

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(b), (c), and (k) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of these substances. these substances. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [65 FR 370, Jan. 5, 2000] [65 FR 370, Jan. 5, 2000]

§ 721.4107 Bicyclo[2.2.1]hept-2-ene, 5- § 721.4110 Allyloxysubstituted octyl-. heterocycle. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified as chemical substance identified generi- Bicyclo[2.2.1]hept-2-ene, 5-octyl- (PMN cally as an allyloxysubstituted P-98–317; CAS No. 22094–84–4) is subject heterocycle (PMN P-93–1471) is subject to reporting under this section for the to reporting under this section for the significant new uses described in para- significant new uses described in paragraph (a)(2) of this section. graph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Release to water. Requirements as (i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and specified in § 721.90 (a)(4), (b)(4), and (c)(1). (c)(4) (where N = 70 ppb). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping requirements. Rec- quirements as specified in § 721.125 (a), ordkeeping requirements specified in (b), (c), and (k) are applicable to manu- § 721.125 (a), (b), (c), and (k) are applica- facturers, importers, and processors of ble to manufacturers, importers, and these substances. processors of this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [65 FR 370, Jan. 5, 2000] [60 FR 11043, Mar. 1, 1995]

§ 721.4108 Bicyclo[2.2.1]hept-2-ene, 5- § 721.4128 Dimethyl-3-substituted decyl-. heteromonocycle. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified chemical substance identified generi- Bicyclo[2.2.1]hept-2-ene, 5-decyl- (PMN cally as dimethyl-3-substituted P-98–318; CAS No. 22094–85–5) is subject heteromonocycle (PMN No. P-91–1322) to reporting under this section for the is subject to reporting under this sec- significant new uses described in para- tion for the significant new uses de- graph (a)(2) of this section. scribed in paragraph (a)(2) of this sec- (2) The significant new uses are: tion. (i) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(1), (b)(1), and (i) Protection in the workplace. Re- (c)(1). quirements as specified in § 721.63 (a)(1), (ii) [Reserved] (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (b) Specific requirements. The provi- (a)(6)(ii), (a)(6)(iii), (a)(6)(v), (b) (con- sions of subpart A of this part apply to centration set at 1.0 percent), and (c). this section except as modified by this (ii) Hazard communication program. paragraph. Requirements as specified in § 721.72 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), (d), (e) (concentration set at 1.0 quirements as specified in § 721.125 (a), percent), (f), (g)(1)(iii), (g)(1)(iv),

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(g)(2)(i), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (1) Recordkeeping. Recordkeeping re- (g)(4)(iii), and (g)(5). quirements as specified in § 721.125 (a), (iii) Industrial, commercial, and con- (b), (d) through (i), and (k) are applica- sumer activities. Requirements as speci- ble to manufacturers, importers, and fied in § 721.80 (g) and (q). processors of this substance. (iv) Release to water. Requirements as (2) Limitations or revocation of certain specified in § 721.90 (a)(1), (b)(1), (c)(1). notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this significant new sions of subpart A of this part apply to use rule. this section except as modified by this (3) Determining whether a specific use is paragraph. subject to this section. The provisions of (1) Recordkeeping. Recordkeeping re- § 721.1725(b)(1) apply to this section. quirements as specified in § 721.125 (a), [58 FR 32238, June 8, 1993, as amended at 58 (b), (d) through (i), and (k) are applica- FR 29946, May 24, 1993] ble to manufacturers, importers, and processors of this substance. § 721.4136 Alkyl heteropolycyclic-ani- (2) Limitations or revocation of certain line (generic). notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this significant new new uses subject to reporting. (1) The use rule. chemical substance identified generi- (3) Determining whether a specific use is cally as alkyl heteropolycyclic-aniline subject to this section. The provisions of (PMN P-00–0067) is subject to reporting § 721.1725(b)(1) apply to this section. under this section for the significant [58 FR 32238, June 8, 1993, as amended at 58 new use described in paragraph (a)(2) of FR 29946, May 24, 1993] this section. (2) The significant new uses are: § 721.4133 Dimethyl-3-substituted (i) Release to water. Requirements as heteromonocyclic amine. specified in § 721.90 (a)(4), (b)(4), and (a) Chemical substance and significant (c)(4) (N=1 ppb). new uses subject to reporting. (1) The (ii) [Reserved] chemical substance identified generi- (b) Specific requirements. The provi- cally as dimethyl-3-substituted sions of subpart A of this part apply to heteromonocycle (PMN No. P-91–1323) this section except as modified by this is subject to reporting under this sec- paragraph. tion for the significant new uses de- (1) Recordkeeping. Recordkeeping re- scribed in paragraph (a)(2) of this sec- quirements as specified in § 721.125 (a), tion. (b), (c), and (k) are applicable to manu- (2) The significant new uses are: facturers, importers, and processors of (i) Protection in the workplace. Re- this substance. quirements as specified in § 721.63 (a)(1), (2) Limitations or revocation of certain (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(2)(iv), notification requirements. The provisions (a)(3), (a)(6)(ii), (a)(6)(iii), (a)(6)(v), (b) of § 721.185 apply to this section. (concentration set at 1.0 percent). [68 FR 15084, Mar. 28, 2003] (ii) Hazard communication program. Requirements as specified in § 721.72 (a), § 721.4140 Hexachloronorbornadiene. (b), (c), (d), (e) (concentration set at 1.0 (a) Chemical substance and significant percent), (f), (g)(1)(iii), (g)(1)(iv), new uses subject to reporting. (1) The (g)(2)(i), (g)(2)(v), (g)(3)(i), (g)(3)(ii), chemical substance 1,2,3,4,7,7- (g)(4)(iii), (g)(5). hexachloronorbornadiene, CAS Number (iii) Industrial, commercial, and con- 3389–71–7, is subject to reporting under sumer activities. Requirements as speci- this section for the significant new use fied in § 721.80 (g) and (q). described in paragraph (a)(2) of this (iv) Release to water. Requirements as section. specified in § 721.90 (a)(1), (b)(1), (c)(1). (2) The significant new use is: Use (b) Specific requirements. The provi- other than as an intermediate in the sions of subpart A of this part apply to production of isodrin or endrin. this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to

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this section except as modified by this (i) Protection in the workplace. Re- paragraph. quirements as specified in § 721.63 (1) Definitions. In addition to the defi- (a)(2)(i) and (a)(3). nitions in § 721.3, the following defini- (ii) Industrial, commercial, and con- tions apply: sumer activities. Requirements as speci- (i) ‘‘Endrin’’ means the pesticide fied in § 721.80 (f) and (j). 2,7:3,6-Dimethanonaphth[2,3-b]oxirene, (b) Specific requirements. The provi- 3,4,5,6,9,9-hexachloro-1a,2,2a,3,6,6a,7,7a- sions of subpart A of this part apply to octahydro-, (1a alpha, this section except as modified by this 2beta,2abeta,3alpha,6alpha,6abeta, paragraph. 7beta,7aalpha)-, CAS Number 72–20–8. (1) Recordkeeping. Recordkeeping re- (ii) ‘‘Isodrin’’ means the pesticide quirements as specified in § 721.125 (a), 1,4:5,8-Dimethano-naph- (b), (c), (d), (e), and (i) are applicable to thalene,1,2,3,4,10,10-hexachloro- manufacturers, importers, and proc- 1,4,4a,5,8,8a-hexahydro-, (1alpha, 4alpha, essors of this substance. 4abeta, 5beta, 8beta, 8abeta)-, CAS Num- (2) Limitations or revocation of certain ber 465–73–6. notification requirements. The provisions (2) [Reserved] of § 721.185 apply to this section. [50 FR 47538, Nov. 19, 1985. Redesignated at 53 [63 FR 3428, Jan. 22, 1998] FR 2845, Feb. 2, 1988. Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 § 721.4160 Hexafluoropropylene oxide. FR 34204, June 23, 1993] (a) Chemical substance and significant § 721.4155 Hexachloropropene. new use subject to reporting. (1) The chemical substance (a) Chemical substance and significant hexafluoropropylene oxide (HFPO), new use subject to reporting. (1) The CAS Number 428–59–1 [Listed in TSCA chemical substance hexachloropropene Inventory as oxirane, trifluor- (CAS No. 1888–71–7) is subject to report- o(trifluoromethyl)-] is subject to re- ing under this section for the signifi- porting under this section for the sig- cant new use described in paragraph nificant new use described in paragraph (a)(2) of this section. (a)(2) of this section. (2) The significant new use is: Manu- (2) The significant new use is any use facture, import, or processing of 10,000 other than as an intermediate in the pounds or more per year per facility for manufacture of fluorinated substances any use. in an enclosed process. (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. The following rec- (1) Definitions. In addition to the defi- ordkeeping requirements are applicable nitions in § 721.3, the following defini- to manufacturers, importers, and proc- tions apply to this section: essors of this substance, as specified in (i) Enclosed process means a process § 721.125 (a), (b), and (c). that is designed and operated so that (2) [Reserved] there is no intentional release of any [58 FR 63517, Dec. 1, 1993] substance present in the process. A process with fugitive, inadvertent, or § 721.4158 Hexadecanoic acid, ethenyl emergency relief releases remains an ester. enclosed process so long as measures (a) Chemical substance and significant are taken to prevent worker exposure new uses subject to reporting. (1) The to and environmental contamination chemical substance identified as hexa- from the releases. decanoic acid, ethenyl ester (PMN P- (ii) [Reserved] 97–302; CAS No. 693–38–9) is subject to (2) [Reserved] reporting under this section for the sig- [52 FR 41300, Oct. 27, 1987. Redesignated at 53 nificant new uses described in para- FR 2845, Feb. 2, 1988. Further redesignated at graph (a)(2) of this section. 58 FR 29946, May 24, 1993, as amended at 58 (2) The significant new uses are: FR 34204, June 23, 1993]

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§ 721.4180 Hexamethylphosphoramide. for Resistance of Protective Clothing (a) Chemical substance and significant Materials to Permeation by Liquids or new uses subject to reporting. (1) The Gases Under Conditions of Intermit- chemical substance hexamethylphos- tent Contact,’’ provided the contact phomide, CAS Number 680–31–9, is sub- time in testing is greater than or equal ject to reporting under this section for to the expected duration of dermal con- the significant new uses described in tact, and the purge time used in test- paragraph (a)(2) of this section. ing is less than or equal to the ex- (2) The significant new use is: Any pected duration of noncontact during use. the intermittent cycle of dermal expo- (b) Special provisions. The provisions sure in the workplace. If ASTM F1383 is of subpart A of the part apply to this used for testing, manufacturers, im- section except as modified by this porters, and processors must submit to paragraph. the Agency a description of worker ac- (1) Persons who must report. Section tivities involving the PMN substance 721.5 applies to this section except for which includes daily frequencies and § 721.5(a)(2). A person who intends to durations of potential worker expo- manufacture, import, or process for sures. The results of all glove perme- commercial purposes the substance ation testing must be reported in ac- identified in paragraph (a)(1) of this cordance with the most current version section and intends to distribute the of ASTM F1194 ‘‘Guide for Docu- substance in commerce must submit a menting the Results of Chemical Per- signficant new use notice. meation Testing of Protective Clothing (2) [Reserved] Materials.’’ Manufacturers, importers, and processors must submit all test [51 FR 9453, Mar. 19, 1986. Redesignated at 53 data to the Agency and must receive FR 2845, Feb. 2, 1988. Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 written Agency approval for each type FR 34204, June 23, 1993] of glove tested prior to use of such gloves. The following gloves have been § 721.4215 Hexanedioic acid, diethenyl tested in accordance with the ASTM ester. F739 method and found by EPA to sat- (a) Chemical substance and significant isfy the requirements for continuous new uses subject to reporting. (1) The use: North/B-161-R/Butyl rubber gloves chemical substance identified as (These gloves are acceptable for the hexanedioic acid, diethenyl ester (PMN solid form of the substance only.), 0.04 P-90–1564) is subject to reporting under cm thick; and Ansell Edmont/4H/PE/ this section for the significant new EVOH/PE Laminate gloves, 0.006 cm uses described in paragraph (a)(2) of thick. (Gloves may not be used for a this section. The requirements of this time period longer than they are actu- section do not apply once the sub- ally tested and must be replaced at the stance has been incorporated into a end of each work shift.), (a)(2)(ii) (With polymer matrix with the level of resid- the exception of laboratory activities, ual monomer below 0.1 percent. full body chemical protective clothing (2) The significant new uses are: (i) is required for any worker activity in Protection in the workplace. Require- which the substance is reasonably like- ments as specified in § 721.63 (a)(1), ly to contact the worker in the fol- (a)(2)(i), (There must be no permeation lowing state(s): Open liquid pool or of the PMN substance greater than 0.05 solid of greater than 5 kg; liquid spray μg/min · cm2 after 8 hours of testing in or splash; mist; aerosol dust; or any accordance with the most current worker activity which have potential version of the American Society for for contact with the PMN chemical for Testing and Materials (ASTM) F739 more than 10 min/h. At a minimum, a ‘‘Standard Test Method for Resistance chemical protective apron is required of Protective Clothing Materials to for any worker activity with potential Permeation by Liquids or Gases.’’ For for contact with the PMN chemical conditions of exposure which are inter- which is not covered by this para- mittent, gloves may be tested in ac- graph)), (a)(2)(iii), (a)(3), (a)(4), cordance with the most current version (a)(5)(iii) (if cartridge service life test- of ASTM F1383 ‘‘Standard Test Method ing is not available), (a)(5)(xii) or

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(a)(5)(xiii) (if data on cartridge service does not apply. Instead, if the waste life testing has been reviewed and ap- stream containing the substance will proved in writing by EPA), (a)(6)(i), be treated before release, then the (a)(6)(ii), (a)(6)(iv), and (a)(6)(v). As an amount of the substance reasonably alternative to the respiratory require- likely to be removed from the waste ments in this section, manufacturers, stream by such treatment may be sub- importers, and processors may use the tracted in calculating the number of New Chemical Exposure Limits provi- kilograms released. No more than 75 sions, including sampling and analyt- percent removal efficiency may be at- ical methods which have previously tributed to such treatment. In addi- been approved by EPA for this sub- tion, when the substance is released in stance, found in the 5(e) consent order combination with the substances for this substance. hexanoic acid, 2-ethyl-, ethenyl ester, (ii) Hazard communication program. neononanoic acid, ethenyl ester, and Requirements as specified in § 721.72 (a), propanoic acid, 2,2-dimethyl-, ethenyl (b), (c), (d), (e) (concentration set at 0.1 ester, the quotient from the formula percent), (f), (h)(1)(vi) (The following referenced in this section shall not ex- additional statements shall appear on ceed the average of the quotient appli- each label required by this paragraph: cable to the other substances weighted The health effects of this material by the proportion of each substance have not been fully determined but are present in the total daily amount re- currently being tested. EPA is con- leased. cerned however, that this material (b) Specific requirements. The provi- may have serious chronic health and sions of subpart A of this part apply to environmental effects. When using this this section except as modified by this material, use eye and skin protection, paragraph. which includes gloves which have been (1) Recordkeeping. Recordkeeping re- determined to be impervious to this quirements as specified in § 721.125 (a) substance. Use respiratory protection, through (i), and (k) are applicable to unless workplace airborne concentra- manufacturers, importers, and proc- tions are maintained at or below an 8– essors of this substance. Manufactur- h time weighted average (TWA) of 1 ers, importers, and processors of the ppm, when there is a likelihood of ex- substance must document that the posure in the work area from dust, PMN substance has been incorporated mist, smoke or vapors.), (h)(2)(ii)(F), into a polymer matrix with the level of (h)(2)(ii)(G), (h)(2)(ii)(I), (h)(2)(iii)(A), residual monomer below 0.1 percent if (h)(2)(iii)(B), (h)(2)(iii)(C), (h)(2)(iii)(E), this section does not apply as described (h)(2)(iv)(A), (h)(2)(iv)(B). The following in paragraph (a)(1) of this section. additional statements shall appear on (2) Limitations or revocation of certain each MSDS required by this paragraph: notification requirements. The provisions This substance may cause moderate of § 721.185 apply to this section. skin irritation. This substance may (3) Determining whether a specific use is cause neurotoxicity. When using this subject to this section. The provisions of substance, use respiratory protection, § 721.1725(b)(1) apply to this section. unless workplace airborne concentrations are maintained at or below an 8– [58 FR 51703, Oct. 4, 1993] h TWA of 1 ppm. (iii) Industrial, commercial, and con- § 721.4250 Hexanoic acid, 2-ethyl-, eth- sumer activities. Requirements as speci- enyl ester. fied in § 721.80(q). (a) Chemical substance and significant (iv) Release to water. Requirements as new uses subject to reporting. (1) The specified in § 721.90 (a)(4), (b)(4), and chemical substance identified as (c)(4) (where N = 80 ppb). When calcu- hexanoic acid, 2-ethyl-, ethenyl ester lating the surface water concentrations (PMN P-91–826) is subject to reporting according to the instructions in under this section for the significant § 721.91(a)(4), the statement that the new uses described in paragraph (a)(2) amount of the substance that will be of this section. The requirements of released will be calculated before the this section do not apply once the sub- substance enters control technology stance has been incorporated into a

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polymer matrix with the level of resid- any worker activity in which the sub- ual monomer below 0.1 percent. stance is reasonably likely to contact (2) The significant new uses are: the worker in the following state(s): (i) Protection in the workplace. Re- Open liquid pool or solid of greater quirements as specified in § 721.63 (a)(1), than 5 kg; liquid spray or splash; mist; (a)(2)(i) (There must be no permeation aerosol dust; or any worker activity of the substance greater than 0.02 μg/ which have potential for contact with min · cm2 after 8 hours of testing in ac- the PMN chemical for more than 10 cordance with the most current version min/h. At a minimum, a chemical proof the American Society for Testing tective apron is required for any work- and Materials (ASTM) F739 ‘‘Standard er activity with potential for contact Test Method for Resistance of Protec- with the PMN chemical which is not tive Clothing Materials to Permeation covered by this paragraph), (a)(2)(iii), by Liquids or Gases.’’ For conditions of (a)(3), (a)(4), (a)(5)(iii) (if cartridge exposure which are intermittent, service life testing is not available), gloves may be tested in accordance (a)(5)(xii) or (a)(5)(xiii) (if data on car- with the most current version of ASTM tridge service life testing has been re- F1383 ‘‘Standard Test Method for Re- viewed and approved in writing by sistance of Protective Clothing Mate- EPA), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), and rials to Permeation by Liquids or (a)(6)(v). As an alternative to the res- Gases Under Conditions of Intermit- piratory requirements in this section, tent Contact,’’ provided the contact manufacturers, importers, and proc- time in testing is greater than or equal essors may use the New Chemical Ex- to the expected duration of dermal con- posure Limits provisions, including tact, and the purge time used in test- sampling and analytical methods ing is less than or equal to the ex- which have previously been approved pected duration of noncontact during by EPA for this substance, found in the the intermittent cycle of dermal expo- 5(e) consent order for this substance. sure in the workplace. If ASTM F1383 is (ii) Hazard communication program. used for testing, manufacturers, im- Requirements as specified in § 721.72 (a), porters, and processors must submit to (b), (c), (d), (e) (concentration set at 0.1 the Agency a description of worker ac- percent), (f), (h)(1)(vi) (The following tivities involving the substance which additional statements shall appear on includes daily frequencies and dura- each label required by this paragraph: tions of potential worker exposures. The health effects of this material The results of all glove permeation have not been fully determined but are testing must be reported in accordance currently being tested. EPA is con- with the most current version of ASTM cerned however, that this material F1194 ‘‘Guide for Documenting the Re- may have serious chronic health and sults of Chemical Permeation Testing environmental effects. When using this of Protective Clothing Materials.’’ material, use eye and skin protection, Manufacturers, importers, and proc- which includes gloves which have been essors must submit all test data to the determined to be impervious to this Agency and must receive written Agen- substance. Use respiratory protection, cy approval for each type of glove test- unless workplace airborne concentra- ed prior to use of such gloves. The fol- tions are maintained at or below an 8– lowing gloves have been tested in ac- h time weighted average (TWA) of 1 cordance with the ASTM F739 method ppm, when there is a likelihood of ex- and found by EPA to satisfy the re- posure in the work area from dust, quirements for continuous use: North/ mist, smoke or vapors.), (h)(2)(ii)(F), F101/Vitron gloves, 0.03 cm thick; and (h)(2)(ii)(G), (h)(2)(ii)(I), (h)(2)(iii)(A), Ansell/Edmont/4H/PE/EVOH/PE Lami- (h)(2)(iii)(B), (h)(2)(iii)(C), (h)(2)(iii)(E), nate gloves, 0.006 cm thick.(Gloves may (h)(2)(iv)(A), (h)(2)(iv)(B). The following not be used for a time period longer additional statements shall appear on than they are actually tested and must each MSDS required by this paragraph: be replaced at the end of each work This substance may cause moderate shift.), (a)(2)(ii) (With the exception of skin irritation. This substance may laboratory activities, full body chem- cause neurotoxicity. When using this ical protective clothing is required for substance, use respiratory protection,

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unless workplace airborne concentra- (3) Determining whether a specific use is tions are maintained at or below an 8– subject to this section. The provisions of h TWA of 1 ppm. § 721.1725(b)(1) apply to this section. (iii) Industrial, commercial, and con- [58 FR 51704, Oct. 4, 1993, as amended at 58 FR sumer activities. Requirements as speci- 68311, Dec. 27, 1993] fied in § 721.80(q). (iv) Release to water. Requirements as § 721.4255 1,4,7,10,13,16- specified in § 721.90 (a)(4), (b)(4), and Hexaoxacyclooctadecane, 2-[(2-pro- (c)(4) (where N = 7 ppb). When calcu- penyl oxy)methyl]-. lating the surface water concentrations (a) Chemical substance and significant according to the instructions in new uses subject to reporting. (1) The § 721.91(a)(4), the statement that the chemical substance 1,4,7,10,13,16- amount of the substance that will be hexaoxacyclooctadecane, 2-[(2- released will be calculated before the propenyloxy)methyl]- (PMN P-93–1208, substance enters control technology CAS no. 84812–04–4) is subject to report- does not apply. Instead, if the waste ing under this section for the signifi- stream containing the substance will cant new uses described in paragraph be treated before release, then the (a)(2) of this section. amount of the substance reasonably (2) The significant new uses are: likely to be removed from the waste (i) Release to water. Requirements as stream by such treatment may be sub- specified in § 721.90 (a)(1), (b)(1), and tracted in calculating the number of (c)(1). kilograms released. No more than 75 (ii) [Reserved] percent removal efficiency may be at- (b) Specific requirements. The provi- tributed to such treatment. In addi- sions of subpart A of this part apply to tion, when the substance is released in this section except as modified by this paragraph. combination with the substances hexanedioic acid, diethenyl ester, (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), neononanoic acid, ethenyl ester, and (b), (c), and (k) are applicable to manu- propanoic acid, 2,2-dimethyl-, ethenyl facturers, importers, and processors of ester, the quotient from the formula this substance. referenced in this section shall not ex- (2) Limitations or revocation of certain ceed the average of the quotient appli- notification requirements. The provisions cable to the other substances weighted of § 721.185 apply to this section. by the proportion of each substance present in the total daily amount re- [59 FR 27484, May 27, 1994] leased. § 721.4257 Hydrazine, (2-fluorophenyl). (b) Specific requirements. The provisions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified as hydra- (1) Recordkeeping. Recordkeeping re- zine, (2-fluorophenyl) (PMN P-95–2101; quirements as specified in § 721.125 (a) CAS No. 2368–80–1) is subject to report- through (i), and (k) are applicable to ing under this section for the significant new uses described in paragraph manufacturers, importers, and proc- (a)(2) of this section. essors of this substance. Manufactur- (2) The significant new uses are: ers, importers, and processors of the (i) Industrial, commercial, and con- substance must document that the sub- sumer activities. Requirements as speci- stance has been incorporated into a fied in § 721.80(f). polymer matrix with the level of resid- (ii) [Reserved] ual monomer below 0.1 percent if this (b) Specific requirements. The provi- section does not apply as described in sions of subpart A of this part apply to paragraph (a)(1) of this section. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a)

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and (i) are applicable to manufactur- facturers, importers, and processors of ers, importers, and processors of this this substance. substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [63 FR 3428, Jan. 22, 1998] [63 FR 3428, Jan. 22, 1998] § 721.4260 Hydrazine, [4-(1-methylbu- § 721.4258 Substituted naphthalene hy- toxy)phenyl]-, monohydrochloride. drazide (generic). (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified as hydra- chemical substance identified generi- zine, [4-(1-methylbutoxy)phenyl]-, cally as substituted naphthalene hydrazide (PMN P-01–69) is subject to re- monohydrochloride (PMN P-90–558; porting under this section for the sig- CAS number 124993–63–1) is subject to nificant new use described in paragraph reporting under this section for the sig- (a)(2) of this section. nificant new uses described in para- (2) The significant new uses are: graph (a)(2) of this section. (i) Release to water. Requirement as (2) The significant new uses are: specified § 721.90(a)(1), (b)(1), and (c)(1). (i) Protection in the workplace. Re- (ii) [Reserved] quirements as specified in § 721.63 (a)(1), (b) Specific requirements. The provi- (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), sions of subpart A of this part apply to (a)(5)(iii), (a)(6)(i), (b) (concentration this section except as modified by this set at 0.1 percent), and (c). paragraph. (ii) Hazard communication program. (1) Recordkeeping. Recordkeeping re- Requirements as specified in § 721.72 (a), quirements as specified in § 721.125(a), (b), (c), (d), (e) (concentration set at 0.1 (b), (c), and (k) are applicable to manu- percent), (f), (g)(1)(i), (g)(1)(iv), facturers, importers, and processors of (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), this chemical substance. (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), (2) Limitations or revocation of certain and (g)(5). In addition, the following notification requirements. The provisions human health hazard statement shall of § 721.185 apply to this section. appear on each label and MSDS re- [68 FR 70177, Dec. 17, 2003] quired by this section: This substance may cause eye irritation. § 721.4259 Aliphatic polyisocyanate (iii) Industrial, commercial, and con- homopolymer. sumer activities. Requirements as speci- (a) Chemical substance and significant fied in § 721.80 (l) and (p) (production new uses subject to reporting. (1) The limit set at 15,500 kg). chemical substance identified generi- (iv) Release to water. Requirements as cally as an aliphatic polyisocyanate specified in § 721.90 (a)(1), (b)(1), and homopolymer (PMN P-96–1239) is sub- (c)(1). ject to reporting under this section for (b) Specific requirements. The provi- the significant new uses described in sions of subpart A of this part apply to paragraph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Industrial, commercial, and con- (1) Recordkeeping requirements. Re- sumer activities. Requirements as speci- quirements as specified in § 721.125 (a) fied in § 721.80(g). through (i) and (k) are applicable to (ii) [Reserved] manufacturers, importers, and proc- (b) Specific requirements. The provi- essors of this substance. sions of subpart A of this part apply to (2) Modification or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this section. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), [57 FR 44066, Sept. 23, 1992, as amended at 58 (b), (c), and (i) are applicable to manu- FR 34204, June 23, 1993]

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§ 721.4265 Hydrazinecarboxamide, N- chemical substance (3,5-difluorophenyl-). nitrophenoxylalkanoic acid substituted (a) Chemical substance and significant thiazino hydrazide (PMN P-88–270) is new uses subject to reporting. (1) The subject to reporting under this section chemical substance identified as for the significant new uses described hydrazinecarboxamide, N-(3,5- in paragraph (a)(2) of this section. difluorophenyl-) (PMN P-97–649; CAS (2) The significant new uses are: No. 167412–23–9) is subject to reporting (i) Protection in the workplace. Re- under this section for the significant quirements as specified in § 721.63 (a)(1), new uses described in paragraph (a)(2) (a)(3), (a)(4), (a)(5)(iv) through of this section. (a)(5)(vii), (a)(6)(i), (b) (concentration (2) The significant new uses are: set at 1.0 percent), and (c). (i) Protection in the workplace. Re- (ii) Hazard communication program. quirements as specified in § 721.63 (a)(1) Requirements as specified in § 721.72 (b), (applies only when the substance is in (c), (d), (e) (concentration set at 1.0 a solution), (a)(4), (a)(5)(i), (a)(6)(i), percent), (f) and (g)(1)(iv) (also acute (a)(6)(v), (b) (concentration set at 0.1 toxicity), (g)(2)(i) through (g)(2)(v), percent), and (c). As an alternative to (g)(4)(i) and (g)(5). The provision of the respiratory requirements listed § 721.72(d) requiring that employees to here, a manufacturer, importer, or be provided with information on the lo- processor may choose to follow the cation and availability of a written NCEL provisions listed in the TSCA hazard communication program does section 5(e) consent order for this sub- not apply when the written program is stance. The NCEL is set at 0.4 mg/m3. not required under § 721.72(a). (ii) Hazard communication program. (iii) Industrial, commercial, and con- Requirements as specified in § 721.72 (a), sumer activities. Requirements as speci- (b), (c), (d), (e) (concentration set at 0.1 fied in § 721.80(g) (industrial intermedi- percent), (f), (g)(1)(i), (g)(1)(iii), ates only). (g)(1)(iv), (g)(1)(v), (g)(1)(vii), (g)(1)(ix), (iv) Disposal. Requirements as speci- (g)(2)(i) (applies only when the sub- fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), stance is in a solvent), (g)(2)(ii), (c)(1) and (c)(2). (g)(2)(iii), (g)(2)(iv), (g)(2)(v) (applies (b) Specific requirements. The provi- only when the substance is in a sol- sions of subpart A of this part apply to vent), and (g)(5). this section except as modified by this (iii) Industrial, commercial, and con- paragraph. sumer activities. Requirements as speci- (1) Recordkeeping. The following rec- fied in § 721.80 (g) and (q). ordkeeping requirements are applicable (b) Specific requirements. The provi- to manufacturers, importers, and proc- sions of subpart A of this part apply to this section except as modified by this essors of this substance, as specified in paragraph. § 721.125 (a) through (j). (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), (d), (e), (f), (g), (h), and (i) are of § 721.185 apply to this significant new applicable to manufacturers, import- use rule. ers, and processors of this substance. [55 FR 32415, Aug. 9, 1990. Redesignated at 58 (2) Limitations or revocation of certain FR 29946, May 24, 1993, as amended at 58 FR notification requirements. The provisions 34204, June 23, 1993] of § 721.185 apply to this section. (3) Determining whether a specific use is § 721.4280 Substituted hydrazine. subject to this section. The provisions of (a) Chemical substance and significant § 721.1725(b)(1) apply to this section. new uses subject to reporting. (1) The [65 FR 370, Jan. 5, 2000] chemical substance identified generically as substituted hydrazine (PMN P- § 721.4270 Nitrophenoxylalkanoic acid 90–594) is subject to reporting under substituted thiazino hydrazide (ge- this section for the significant new neric name). uses described in paragraph (a)(2) of (a) Chemical substance and significant this section. new uses subject to reporting. (1) The (2) The significant new uses are:

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(i) Protection in the workplace. Re- (iii) Industrial, commercial, and con- quirements as specified in § 721.63 (a)(1), sumer activities. Requirements as speci- (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (b) (con- fied in § 721.80 (f), (k) (any application centration set at 0.1 percent), and (c). which, if there are releases to water or (ii) Hazard communication program. discharges to land, will not result in Requirements as specified in § 721.72 (a), releases to facilities with a National (b), (c), (d), (e) (concentration set at 0.1 Pollutant Discharge Elimination Sys- percent), (f), (g)(1)(iv), (g)(1)(vii), (g)(2), tem permit), and (l). (g)(3), (g)(4)(i), (g)(4)(iii), and (g)(5). In (iv) Release to water. Requirements as addition, the human health hazard specified in § 721.90 (b)(4), (c)(4), (where statement shall include mutagenicity. N = 30). (iii) Industrial, commercial, and con- (A) Selling or transferring the sub- sumer activities. Requirements as speci- stance to any person for use where the fied in § 721.80(l). substance is released to surface waters (iv) Disposal. Requirements as speci- without notifying in writing the par- fied in § 721.85 (a)(1), (b)(1), and (c)(1). ties listed in subparagraph (B) of the (v) Release to water. Requirements as identities of all such persons. Such no- specified in § 721.90 (a)(1), (b)(1), and tification shall be sent within 15 days (c)(1). of the date of the first sale or transfer (b) Specific requirements. The provi- and shall contain the following infor- sions of subpart A of this part apply to mation: this section except as modified by this (1) The name and address (including paragraph. shipment destination address, if dif- (1) Recordkeeping. The following rec- ferent) of the person to whom the sub- ordkeeping requirements are applicable stance is sold or transferred. to manufacturers, importers, and proc- (2) The date on which sale or transfer essors of this substance, as specified in commenced. § 721.125 (a) through (k). (3) The chemical identity of the sub- (2) Limitations or revocation of certain stance. notification requirements. The provisions of § 721.185 apply to this significant new (4) The name of the stream or river use rule. into which the specific buyer or transferee is expected to discharge the sub- [56 FR 40213, Aug. 13, 1991. Redesignated at 58 stance. FR 29946, May 24, 1993, as amended at 58 FR (5) Notification that the substance is 34204, June 23, 1993] subject to a Significant New Use Rule § 721.4300 Hydrazinecarboxamide, issued under section 5 of the Toxic Sub- N,N′-1,6–hexanediylbis [2,2-distances Control Act. methyl-]. (6) A summary of the water release (a) Chemical substance and significant restrictions contained in paragraph new uses subject to reporting. (1) The (a)(iv) of this section. chemical substance identified as (7) A request that the party notify hydrazinecarboxamide, N,N′-1,6-hexane- the following office of any information diylbis [2,2-dimethyl- (P-87–1192)] is which indicates that the in-stream con- subject to reporting under this section centration of the PMN substance speci- for the significant new uses described fied in paragraph (a)(iv) of this section in paragraph (a)(2) of this section. has been exceeded: Chief, New Chemi- (2) The significant new uses are: cals Branch, Chemical Control Division (i) Protection in the workplace. Re- (7405), Office of Pollution Prevention quirements as specified in § 721.63 (a)(4), and Toxics, U.S. Environmental Pro- (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), tection Agency, Room E–447, 1200 Penn- (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(6)(i), sylvania Ave., NW., Washington, DC (b) (concentration set at 0.1 percent), 20460. and (c). (B) The parties to be notified are as (ii) Hazard communication program. follows. Requirements as specified in § 721.72 (a), (1) The Director, Water Management (b), (c), (d), (e) (concentration set a 0.1 Division (or, in the case of Regions 5 percent), (f), (g)(1)(vii), (g)(2)(ii), and 10, Water Division) at the head- (g)(2)(iii), (g)(2)(iv), (g)(3), and (g)(5). quarters of the EPA region in which

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the specific buyer or transferee is lo- (b)(2), (d), (e) (concentration set at 0.1 cated. percent), (f), (g)(1)(iv) (and blood ef- (2) The Agency, Department, or Of- fects), (g)(1)(vii), (g)(2)(iv), (g)(2)(v), fice of the State or U.S. Territory with (g)(4)(iii), and (g)(5). The provisions of jurisdiction over point source water § 721.72(d) requiring employees to be discharges in the State or Territory in provided with information on the loca- which the specific buyer or transferee tion and availability of a written haz- is located (EPA is available for con- ard communication program and sultation regarding the identity and MSDSs do not apply when the written address of the appropriate Agency, program and MSDS are not required etc.) under § 721.72 (a) and (c), respectively. (3) The Publicly Owned Treatment The provision of § 721.72(g) requiring Works (POTW) authority, if any, ex- placement of specific information on pected to receive the discharge of the an MSDS does not apply when an PMN substance from the specific buyer MSDS is not required under § 721.72(c). or transferee. (iii) Industrial, commercial, and con- (b) Specific requirements. The provi- sumer activities. Requirements as speci- sions of subpart A of this part apply to fied in § 721.80 (f) and (l). this section except as modified by this (iv) Release to water. Requirements as paragraph. specified in § 721.90 (b)(1) and (c)(1). (1) Recordkeeping requirements. The (b) Specific requirements. The provi- following recordkeeping requirements sions of subpart A of this part apply to are applicable to manufacturers, im- this section except as modified by this porters, and processors of this subparagraph. stance as specified in § 721.125 (a), (b), (1) Recordkeeping. The following rec- (c), (d), (f), (g), (h), (i), and records doc- ordkeeping requirements are applicable umenting notification to parties iden- to manufacturers, importers, and proc- tified in § 721.90. essors of this substance, as specified in (2) Limitations or revocation of certain § 721.125 (a), (b), (c), (e), (f), (g), (h), and notification requirements. The provisions (k). of § 721.185 apply to this significant new (2) Limitations or revocation of certain use rule. notification requirements. The provisions (3) Determining whether a specific use is of § 721.185 apply to this significant new The provisions of subject to this section. use rule. § 721.1725(b)(1) apply to this section. [55 FR 46773, Nov. 6, 1990. Redesignated at 58 [56 FR 15792, Apr. 17, 1991. Redesignated and FR 29946, May 24, 1993, as amended at 58 FR amended at 58 FR 29946, May 24, 1993; 58 FR 34204, June 23, 1993] 34204, June 23, 1993; 60 FR 34464, July 3, 1995]

§ 721.4320 Hydrazinecarboxamide, § 721.4340 Substituted thiazino hydra- N,N′-(methylenedi-4,1-phenylene)bis zine salt (generic name). [2,2-dimethyl-. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance substituted chemical substance thiazino hydrazine salt (PMN P-88–63) hydrazinecarboxamide, N,N′- is subject to reporting under this sec- (methylenedi-4,1-phenylene)bis[2,2- tion for the significant new uses de- dimethyl- (PMN P-88–522) is subject to scribed in paragraph (a)(2) of this sec- reporting under this section for the sig- tion. nificant new uses described in para- (2) The significant new uses are: graph (a)(2) of this section. (i) Protection in the workplace. Re- (2) The significant new uses are: quirements as specified in § 721.63 (a)(1), (i) Protection in the workplace. Re- (a)(3), (a)(4), (a)(5)(iii) through quirements as specified in § 721.63 (a)(1), (a)(5)(vii), and (a)(6)(i), (b) [concentra- (a)(3), (a)(4), (a)(5)(viii) through tion set at 0.1 percent], and (c). (a)(5)(xiv), (a)(6)(i), (a)(6)(ii), (b) (con- (ii) Hazard communication program. centration set at 0.1 percent), and (c). Requirements as specified in § 721.72 (a), (ii) Hazard communication program. (b)(2), (c), (d), (e) [concentration set at Requirements as specified in § 721.72 0.1 percent], (f), and (g)(1)(iv) and

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(g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (b) Specific requirements. The provi- and (g)(2)(v), (g)(4)(i), and (g)(5). sions of subpart A of this part apply to (iii) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80 (g) and (l). (1) Recordkeeping. Recordkeeping re- (iv) Disposal. Requirements as speci- quirements as specified in § 721.125 (a), fied in § 721.85 (a)(1) and (a)(2) and (b)(1) (b), (c), and (k) are applicable to manu- and (b)(2). facturers, importers, and processors of (b) Specific requirements. The provi- this substance. sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this section. (1) Recordkeeping. The following rec- [65 FR 81400, Dec. 26, 2000] ordkeeping requirements are applicable to manufacturers, importers, and proc- § 721.4380 Modified hydrocarbon resin. essors of this substance, as specified in (a) Chemical substance and significant § 721.125 (a) through (i). new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified generi- notification requirements. The provisions cally as a modified hydrocarbon resin of § 721.185 apply to this significant new (P-91–1418) is subject to reporting under use rule. this section for the significant new [55 FR 26112, June 26, 1990. Redesignated at 58 uses described in paragraph (a)(2) of FR 29947, May 24, 1993, as amended at 58 FR this section. 34204, June 23, 1993] (2) The significant new uses are: (i) Hazard communication program. A § 721.4360 Certain hydrogen con- significant new use of this substance is taining chlorofluorocarbons. any manner or method of manufacture, (a) Chemical substances and signifi- import, or processing associated with cant new uses subject to reporting. any use of this substance without pro- (1) The chemical substances ethane, viding risk notification as follows: 2-chloro-1,1,1-trifluoro- (CAS Number (A) If as a result of the test data re- 75–88–7) and ethane, 1,2-dichloro-1,1- quired under the section 5(e) consent difluoro- (CAS Number 1649–08–7) are order for this substance, the employer subject to reporting under this section becomes aware that this substance for the significant new use described in may present a risk of injury to human paragraph (a)(2) of this section. health, the employer must incorporate this new information, and any informa- (2) The significant new use is: Use tion on methods for protecting against other than as an intermediate. such risk, into an MSDS as described (b) [Reserved] in § 721.72(c) within 90 days from the [55 FR 35632, Aug. 31, 1990. Redesignated at 58 time the employer becomes aware of FR 29946, May 24, 1993, as amended at 58 FR the new information. If this substance 34204, June 23, 1993] is not being manufactured, imported, processed, or used in the employer’s § 721.4365 Substituted ethoxylated hy- workplace, the employer must add the drocarbon (generic). new information to an MSDS before (a) Chemical substance and significant the substance is reintroduced into the new uses subject to reporting. (1) The workplace. chemical substance identified generi- (B) The employer must ensure that cally as Substituted ethoxylated hy- persons who will receive this substance drocarbon (PMN P-99–0313) is subject to from the employer, or who have re- reporting under this section for the sig- ceived the substance from the em- nificant new use described in paragraph ployer within 5 years from the date the (a)(2) of this section. employer becomes aware of the infor- (2) The significant new uses are: mation described in paragraph (i) Release to water. Requirements as (a)(2)(i)(A) of this section, are provided specified § 721.90 (a)(4), (b)(4), and (c)(4) an MSDS as described in § 721.72(c) con- (N=1 ppb). taining the information required under (ii) [Reserved] paragraph (a)(2)(i)(A) of this section

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within 90 days from the time the em- chemical substance identified generi- ployer becomes aware of the new infor- cally as trisubstituted hydroquinone mation. diester (PMN No. P-92–329) is subject to (ii) Industrial, commercial, and con- reporting under this section for the sig- sumer activities. Requirements as speci- nificant new uses described in para- fied in § 721.80(q). graph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Hazard communication program. Re- this section except as modified by this quirements as specified in § 721.72 (a), paragraph. (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (1) Recordkeeping requirements. Re- (g)(4)(i), and (g)(5). quirements as specified in § 721.125 (a), (ii) Release to water. Requirements as (h), and (i) are applicable to manufac- specified in § 721.90 (a)(4), (b)(4) (where turers, importers, and processors of N = 30 ppb). this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. (3) Determining whether a specific use is (1) Recordkeeping. Recordkeeping re- subject to this section. The provisions of quirements as specified in § 721.125 (a), § 721.1725(b)(1) apply to this section. (b), (c), (f), (g), (h), (j), and (k) are applicable to manufacturers, importers, [57 FR 44067, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 58 FR 34204, June 23, and processors of this substance. 1993] (2) Limitations or revocation of certain notification requirements. The provisions § 721.4385 Hydrofluoric acid, reaction of § 721.185 apply to this significant new products with heptane. use rule. (a) Chemical substance and significant [58 FR 32239, June 8, 1993] new uses subject to reporting. (1) The chemical substance identified as a § 721.4420 Substituted hydroxylamine. hydrofluoric acid, reaction products (a) Chemical substance and significant with heptane (PMN P-98–1036; CAS No. new uses subject to reporting. (1) The 207409–71–0) is subject to reporting chemical substance identified generi- under this section for the significant cally as substituted hydroxylamine new use described in paragraph (a)(2) of (PMN P-84–492) is subject to reporting this section. under this section for the significant (2) The significant new uses are: new uses described in paragraph (a)(2) (i) Industrial, commercial, and con- of this section. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80(g). (i) Protection in the workplace. Re- (ii) [Reserved] quirements as specified in § 721.63 (a)(1), (b) Specific requirements. The provi- (a)(3), (b) (concentration set at 0.1 per- sions of subpart A of this part apply to cent), and (c). this section except as modified by this (ii) Hazard communicatiom program. paragraph. Requirements as specified in § 721.72 (1) Recordkeeping. Recordkeeping re- (b)(2), (d), (e) (concentration set at 0.1 quirements as specified in § 721.125 (a), percent), (f), (g)(1)(vii), and (g)(2)(i) (b), (c), and (i) are applicable to manu- through (g)(2)(iii). The provisions of facturers, importers, and processors of § 721.72(d) requiring employees to be this substance. provided with information on the loca- (2) Limitations or revocation of certain tion and availability of a written haz- notification requirements. The provisions ard communication program and of § 721.185 apply to this section. MSDSs do not apply when the written [65 FR 370, Jan. 5, 2000] program and MSDS are not required under § 721.72 (a), and (c), respectively. § 721.4390 Trisubstituted hydro- The provision of § 721.72(g) requiring quinone diester. placement of specific information on (a) Chemical substance and significant an MSDS does not apply when an new uses subject to reporting. (1) The MSDS is not required under § 721.72(c).

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(iii) Industrial, commercial, and con- (2) Limitations or revocation of certain sumer activities. Requirements as speci- notification requirements. The provisions fied in § 721.80(k). of § 721.185 apply to this section. (iv) Release to water. Requirements as [57 FR 46466, Oct. 8, 1992, as amended at 58 FR specified in § 721.90 (a)(4) (chemically 34204, June 23, 1993] treated liquid wastes must contain no more than 10 ppm of the substance § 721.4461 Hydrofluoric acid, reaction prior to discharge), (b)(4) (chemically products with octane (generic). treated liquid wastes must contain no more than 10 ppm of the substance (a) Chemical substance and significant prior to discharge), and (c)(4) (chemi- new uses subject to reporting. (1) The cally treated liquid wastes must con- chemical substance identified generi- tain no more than 10 ppm of the sub- cally as a hydrofluoric acid, reaction stance prior to discharge). products with octane (PMN P-99–0052) (b) Specific requirements. The provi- is subject to reporting under this sec- sions of subpart A of this part apply to tion for the significant new use de- this section except as modified by this scribed in paragraph (a)(2) of this sec- paragraph. tion. (1) Recordkeeping. The following rec- (2) The significant new uses are: ordkeeping requirements are applicable (i) Release to water. Requirements as to manufacturers, importers, and proc- specified in § 721.90 (a)(1), (b)(1), and essors of this substance, as specified in (c)(1). § 721.125 (a), (b), (c), (e), (f), and (j). (ii) [Reserved] (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this significant new this section except as modified by this use rule. paragraph. (3) Determining whether a specific use is (1) Recordkeeping. Recordkeeping re- subject to this section. The provisions of quirements as specified in § 721.125 (a), § 721.1725(b)(1) apply to this section. (b), (c), and (k) are applicable to manu- [55 FR 46773, Nov. 6, 1990. Redesignated and facturers, importers, and processors of amended at 58 FR 29946, May 24, 1993; 58 FR this substance. 34204, June 23, 1993] (2) Limitations or revocation of certain notification requirements. The provisions § 721.4460 Amidinothiopropionic acid of § 721.185 apply to this section. hydrochloride. [65 FR 81400, Dec. 26, 2000] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.4462 Hydrochlorofluorocarbon. chemical substance identified generically as amidinothiopropionic acid hy- (a) Chemical substance and significant drochloride (PMN P-91–102) is subject new uses subject to reporting. (1) The to reporting under this section for the chemical substance identified generi- significant new uses described in para- cally as a hydrochlorofluorocarbon graph (a)(2) of this section. (PMN P-95–1317) is subject to reporting (2) The significant new uses are: under this section for the significant (i) Industrial, commercial, and con- new uses described in paragraph (a)(2) sumer activities. Requirements as speci- of this section. fied in § 721.80(f). (2) The significant new uses are: (ii) [Reserved] (i) Industrial, commercial, and con- (b) Specific requirements. The provi- sumer activities. Requirements as speci- sions of subpart A of this part apply to fied in § 721.80(g). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping requirements. Re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), and (i) are applicable to manu- paragraph. facturers, importers, and processors of (1) Recordkeeping. Recordkeeping re- this substance. quirements as specified in § 721.125 (a),

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§ 721.4463 Hydrochlorofluorocarbon. § 721.4465 Hydrofluoroalkane. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified generically as a hydrochlorofluorocarbon cally as a hydrofluoroalkane (PMN P- (PMN P-94–1453) is subject to reporting 96–1288) is subject to reporting under under this section for the significant this section for the significant new new uses described in paragraph (a)(2) uses described in paragraph (a)(2) of of this section. this section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial and consumer (i) Industrial, commercial, and con- activities. Requirements as specified in sumer activities. Requirements as speci- § 721.80(g). fied in § 721.80(h). (ii) [Reserved] (ii) [Reserved] (b) The provi- Specific requirements. (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a) (b), (c), and (i) are applicable to manu- and (i) are applicable to manufactur- facturers, importers, and processors of ers, importers, and processors of this this substance. substance. (2) Limitations or revocation of certain (2) notification requirements. The provisions Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions of § 721.185 apply to this section. [60 FR 45082, Aug. 30, 1995] [63 FR 3428, Jan. 22, 1998] § 721.4464 Mixture of hydrofluoro alkanes and hydrofluoro alkene. § 721.4467 Quaternary ammonium hydroxide. (a) Chemical substance and significant new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substances identified generi- new uses subject to reporting. (1) The cally as a mixture of hydrofluoro chemical substance identified generi- alkanes and hydrofluoro alkene (PMNs cally as a quaternary ammonium hy- P-96–945/946/947/948) are subject to re- droxide (PMN P-95–1806) is subject to porting under this section for the sig- reporting under this section for the significant new uses described in para- nificant new uses described in paragraph (a)(2) of this section. graph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial, and con- (i) Release to water. Requirements as sumer activities. Requirements as speci- specified in § 721.90 (a)(1), (b)(1), and fied in § 721.80(g). (c)(1). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements specified as in § 721.125 (a), quirements as specified in § 721.125 (a),

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(b), (c), and (k) are applicable to manu- (ii) Hazard communication program. facturers, importers, and processors of Requirements as specified in § 721.72 (a), this substance. (b), (c), (d), (e) (concentration set at 0.1 (2) Limitations or revocation of certain percent), (f), (g)(1)(ix), (g)(2)(i), notification requirements. The provisions (g)(2)(v), and (g)(5). The label and of § 721.185 apply to this section. MSDS as required by this paragraph [63 FR 3429, Jan. 22, 1998] shall also include the following statements: This substance may cause thy- § 721.4468 1H-Imidazole, 2-ethyl-4,5- roid cancer. This substance may cause dihydro-4-methyl-. thyroid effects. (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified as 1H- this section except as modified by this imidazole, 2-ethyl-4,5-dihydro-4- paragraph. methyl- (PMN P-97–217; CAS No. 931–35– (1) Recordkeeping. Recordkeeping re- 1) is subject to reporting under this quirements as specified in § 721.125 (a), section for the significant new uses de- (b), (c), (d), (e), (f), (g), and (h) are ap- scribed in paragraph (a)(2) of this sec- plicable to manufacturers, importers, tion. and processors of this substance. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Release to water. Requirements as notification requirements. The provisions specified in § 721.90 (a)(4), (b)(4), and of § 721.185 apply to this section. (c)(4) (N = 40). (ii) [Reserved] [63 FR 3429, Jan. 22, 1998] (b) Specific requirements. The provi- § 721.4470 2,4-Imidazolidinedione, sions of subpart A of this part apply to bromochloro-5,5-dimethyl-. this section except as modified by this paragraph. (a) Chemical substance and significant (1) Recordkeeping. Recordkeeping renew uses subject to reporting. (1) The quirements as specified in § 721.125 (a), chemical substance 2,4- (b), (c), and (k) are applicable to manu- imidazolidinedione, bromochloro-5,5- facturers, importers, and processors of dimethyl- (PMN P-94–34) is subject to this substance. reporting under this section for the sig- (2) Limitations or revocation of certain nificant new uses described in para- notification requirements. The provisions graph (a)(2) of this section. of § 721.185 apply to this section. (2) The significant new uses are: [63 FR 3429, Jan. 22, 1998] (i) Industrial, commercial, and consumer activities. Requirements as speci- § 721.4469 Imidazolethione. fied in § 721.80 (v)(3), (w)(3), and (x)(3). (a) Chemical substance and significant (ii) Release to water. Requirements as new uses subject to reporting. (1) The specified in § 721.90 (a)(4), (b)(4), and chemical substance identified generi- (c)(4) (where N = 10 ppb). cally as an imidazolethione (PMNs P- (b) Specific requirements. The provi- 91–1131 and P-90–564) is subject to re- sions of subpart A of this part apply to porting under this section for the sig- this section except as modified by this nificant new uses described in para- paragraph. graph (a)(2) of this section. Formula- (1) Recordkeeping requirements. Rec- tions or mixtures containing the PMN ordkeeping requirements specified in substance in concentrations at or § 721.125 (a), (b), (c), (i), and (k) are ap- below 10 percent by weight or volume plicable to manufacturers, importers, are exempt from the provisions of this and processors of this substance. rule. (2) Limitations or revocation of certain (2) The significant new uses are: notification requirements. The provisions (i) Protection in the workplace. Re- of § 721.185 apply to this section. quirements as specified in § 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 per- [60 FR 11043, Mar. 1, 1995] cent), and (c).

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§ 721.4472 Phenyl, alkyl, hydroxyalkyl receiving the written protocols. Pub- substituted imidazole (generic). lished test guidelines specified in para- (a) Chemical substance and significant graph (a)(2)(iii) of this section (e.g., 40 new uses subject to reporting. (1) The CFR part 797 or part 798) provide gen- chemical substance identified generi- eral guidance for development of test cally as phenyl, alkyl, hydroxyalkyl protocols, but are not themselves ac- substituted imidazole (PMNs P-98–843 ceptable protocols. and P-86–65) are subject to reporting (C) The person shall: under this section for the significant (1) Conduct each study in good faith new uses described in paragraph (a)(2) with due care. of this section. (2) Promptly furnish to EPA the re- (2) The significant new uses are: sults of any interim phase of each (i) Protection in the workplace. Re- study. quirements as specified in § 721.63 (a)(1), (3) Submit, in triplicate (with an ad- (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), ditional sanitized copy, if confidential (a)(5)(vi), (b) (concentration set at 1.0 business information is involved), the percent), and (c). final report of each study and all un- (ii) Hazard communication program. derlying data (‘‘the report and data’’) Requirements as specified in § 721.72 (a), to EPA no later than 14 weeks prior to (b), (c), (d), (e) (concentration set at 1.0 exceeding the applicable production percent), (f), and (g)(1)(iii). volume limit. The final report shall (iii) Industrial, commercial, and con- contain the contents specified in 40 sumer activities. Requirements as speci- CFR 792.185. fied in § 721.80(r) (56,000 kg) (acute oral (D)(1) Except as described in para- study (OPPTS 870.1100 test guideline) graph (a)(2)(iii)(D)(2), if, within 6 weeks followed by a (90-day subchronic inha- of EPA’s receipt of a test report and lation study in rats (40 CFR 799.9346). A data, the person receives written no- person may not manufacture or import tice that EPA finds that the data gen- the substance beyond the aggregate erated by a study are scientifically in- production volume limit, unless that person conducts this study on the sub- valid, the person is prohibited from fur- stance and submits all final reports ther manufacture and import of the and underlying data in accordance with PMN substance beyond the applicable the procedures and criteria specified in production volume limit. paragraphs (a)(2)(iii)(A), (a)(2)(iii)(B), (2) The person may continue to man- (a)(2)(iii)(C), and (a)(2)(iii)(D) of this ufacture and import the PMN subsection. stance beyond the applicable produc- (A) Each study required to be per- tion limit only if so notified, in writ- formed pursuant to this section must ing, by EPA in response to the person’s be scientifically valid. Scientifically compliance with either of the following valid means that the study was con- paragraphs (a)(2)(iii)(D)(2)(i) or ducted according to: (a)(2)(iii)(D)(2)(ii) of this section. (1) The test guidelines specified in (i) The person may reconduct the paragraph (a)(2)(iii) of this section. study. If there is sufficient time to re- (2) An EPA-approved protocol. conduct the study and submit the re- (3) TSCA Good Laboratory Practice port and data to EPA at least 14 weeks Standards at 40 CFR part 792. before exceeding the production limit (4) Using methodologies generally ac- as required by paragraph (a)(2)(iii)(C)(3) cepted at the time the study is initi- of this section, the person shall comply ated. with paragraph (a)(2)(iii)(C)(3) of this (5) Any deviation from these require- section. If there is insufficient time for ments must be approved in writing by the person to comply with paragraph EPA. (a)(2)(iii)(C)(3) of this section, the per- (B) Before starting to conduct any of son may exceed the production limit the studies in paragraph (a)(2)(iii) of and shall submit the report and data in this section, the person must obtain triplicate to EPA within a reasonable approval of test protocols from EPA by period of time, all as specified by EPA submitting written protocols. EPA will in the notice described in paragraph respond to the person within 4 weeks of (a)(2)(iii)(D)(1) of this section. EPA will

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respond to the person in writing, with- (2) Limitations or revocation of certain in 6 weeks of receiving the person’s re- notification requirements. The provisions port and data. of § 721.185 apply to this section. (ii) The person may, within 4 weeks [60 FR 45082, Aug. 30, 1995] of receiving from EPA the notice described in paragraph (a)(2)(iii)(D)(1) of § 721.4476 Substituted imines. this section, submit to EPA a written report refuting EPA’s finding. EPA will (a) Chemical substance and significant respond to the person in writing, with- new uses subject to reporting. (1) The in 4 weeks of receiving the person’s re- chemical substances identified generi- port. cally as substituted imines (PMNs P- (E) The person is not required to con- 95–1557/1558) are subject to reporting duct a study specified in paragraph under this section for the significant (a)(2)(iii) of this section if notified in new uses described in paragraph (a)(2) writing by EPA that it is unnecessary of this section. to conduct that study. (2) The significant new uses are: (iv) Release to water. Requirements as (i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and specified in § 721.90 (a)(1), (b)(1), and (c)(1). (c)(1). (b) Specific requirements. The provi- (ii) [Reserved] sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), (d), (e), (f), (g), (h), (i), and (k) quirements as specified in § 721.125 (a), are applicable to manufacturers, im- (b), (c), and (k) are applicable to manu- porters, and processors of this sub- facturers, importers, and processors of stance. these substances. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [65 FR 370, Jan. 5, 2000] [63 FR 3429, Jan. 22, 1998]

§ 721.4473 Dialkylamidoimidazoline. § 721.4480 2-Imino-1,3-thiazin-4-one-5,6- dihydromonohydrochloride. (a) Chemical substance and significant new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified as new uses subject to reporting. (1) The dialkylamidoimidazoline (PMN P-94– chemical substance identified as 2- 1864) is subject to reporting under this imino-1,3-thiazin-4-one-5,6- section for the significant new uses de- dihydromonohydrochloride (PMN P-91– scribed in paragraph (a)(2) of this sec- 101) is subject to reporting under this tion. section for the significant new uses de- (2) The significant new uses are: scribed in paragraph (a)(2) of this sec- (i) Industrial, commercial, and con- tion. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80(h). (i) Industrial, commercial, and con- (ii) [Reserved] sumer activities. Requirements as speci- (b) Specific requirements. The provi- fied in § 721.80 (f), (v)(1), (v)(2), (w)(1), sions of subpart A of this part apply to (w)(2), (x)(1), and (x)(2). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a) this section except as modified by this and (i) are applicable to manufactur- paragraph. ers, importers, and processors of this (1) Recordkeeping requirements. Re- substance. quirements as specified in § 721.125 (a),

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(b), (c), and (i) are applicable to manu- § 721.4486 Propanoic acid, 2-methyl-, facturers, importers, and processors of (1R,2R,4R)-1,7,7- this substance. trimethylbicyclo[2.2.1]hept-2-yl (2) Limitations or revocation of certain ester, rel-. notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The chemical substances identified as pro- [57 FR 46466, Oct. 8, 1992, as amended at 58 FR panoic acid, 2-methyl-, (1R,2R,4R)-1,7,7- 34204, June 23, 1993] trimethylbicyclo[2.2.1]hept-2-yl ester, rel- (PMNs P-98–0497 and P-98–0509; CAS § 721.4484 Halogenated indane (generic name). No. 85586–67–0) are subject to reporting under this section for the significant (a) Chemical substance and significant new use described in paragraph (a)(2) of new uses subject to reporting. (1) The this section. chemical substance identified generi- (2) The significant new uses are: cally as a halogenated indane (PMN P- (i) Industrial, commercial, and con- 94–351) is subject to reporting under sumer activities. Requirements as speci- this section for the significant new fied in § 721.80(p) (15,000 kg/yr). uses described in paragraph (a)(2) of (ii) [Reserved] this section. The requirements of this (b) Specific requirements. The provi- section do not apply to P-94–351 after sions of subpart A of this part apply to incorporation into a plastic, resin ma- this section except as modified by this trix, or pelletized so humans are not paragraph. reasonally likely to be exposed. (1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a), (i) Protection in the workplace. Re- (b), (c), and (i) are applicable to manu- quirements during manufacture as facturers, importers, and processors of specified in § 721.63 (a)(5)(iii), (a)(5)(iv), this substance. (a)(5)(v), (a)(5)(vi), (a)(5(vii), (a)(6)(i), (2) Limitations or revocation of certain notification requirements. The provisions (b) (concentration set at 0.1 percent), of § 721.185 apply to this section. and (c). (ii) Hazard communication program. [68 FR 15084, Mar. 28, 2003] Requirements during manufacture as specified in § 721.72 (a), (b), (c), (d), (e), § 721.4490 Capped aliphatic isocyanate. (f), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5). (a) Chemical substance and significant (iii) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified generi- fied in § 721.80(q). cally as a capped aliphatic isocyanate (PMN P-86–1146) is subject to reporting (b) Specific requirements. The provi- under this section for the significant sions of subpart A of this part apply to new uses described in paragraph (a)(2) this section except as modified by this of this section. paragraph. (2) The significant new uses are: (1) Recordkeeping. Recordkeeping re- (i) Protection in the workplace. Re- quirements as specified in § 721.125 (a), quirements as specified in § 721.63 (a)(1), (b), (c), (d), (e), (f), (g), (h), and (i) are (a)(3), (a)(4), (a)(5)(xi), (a)(6)(v), (b) applicable to manufacturers, import- (concentration set at 0.1 percent), and ers, and processors of this substance. (c). (2) Limitations or revocation of certain (ii) Hazard communication program. notification requirements. The provisions Requirements as specified in § 721.72 (a), of § 721.185 apply to this section. (b), (d), (e) (concentration set at 0.1 (3) Determining whether a specific use is percent), (f), (h)(1)(ii)(G), (h)(1)(iii)(A), subject to this section. The provisions of (h)(1)(iii)(B), (h)(1)(iii)(D), and § 721.1725(b)(1) apply to this section. (h)(1)(iii)(E). (iii) Industrial, commercial, and con- [61 FR 63737, Dec. 2, 1996, as amended at 62 sumer activities. Requirements as speci- FR 27694, May 21, 1997] fied in § 721.80(h).

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(iv) Disposal. Requirements as speci- manufacturers, importers, and proc- fied in § 721.90 (a)(1), (a)(2), (b)(1), (b)(2), essors of this substance. (c)(1), and (c)(2). (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this (3) Determining whether a specific use is paragraph. subject to this section. The provisions of (1) Recordkeeping. Recordkeeping re- § 721.1725(b)(1) apply to this section. quirements as specified in § 721.125 (a), [61 FR 63737, Dec. 2, 1996] (b) through (g), (i), and (j) are applicable to manufacturers, importers, and § 721.4497 Aliphatic polyisocyanates processors of this substance. (generic name). (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substances identified generi- [58 FR 51685, Oct. 4, 1993] cally as aliphatic polyisocyanates (P- 91–1210 and P-92–714) are subject to re- § 721.4494 Polycyclic isocyanate. porting under this section for the sig- (a) Chemical substance and significant nificant new uses described in para- new uses subject to reporting. (1) The graph (a)(2) of this section. Non-spray chemical substance identified as a uses are exempt from the provisions of polycyclic isocyanate (PMN P-94–437) is this rule. subject to reporting under this section (2) The significant new uses are: for the significant new uses described (i) Protection in the workplace. Re- in paragraph (a)(2) of this section. quirements as specified in § 721.63 (a)(1), (2) The significant new uses are: (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i), (i) Protection in the workplace. Re- (a)(5)(ii), (a)(5)(iii), (a)(5)(viii), quirements as specified in § 721.63 (a)(1), (a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(6)(i), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(ii), (a)(6)(ii), (a)(6)(iv), (b) (concentration (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), set at 1.0 percent), and (c). (b) (concentration set at 1.0%), and (c). (ii) Hazard communication program. (ii) Hazard communication program. Requirements as specified in § 721.72 (a), Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5). Manufacturers, importers, (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). In and processors who implement the addition the following human health product stewardship provisions of the and environmental hazard and pre- section 5(e) consent order for these sub- cautionary statements shall appear on stances are exempt from the require- each label as specified in paragraph (b) ments of §§ 721.63 and 721.72. of this section and the MSDS as speci- (b) Specific requirements. The provi- fied in paragraph (c) of this section: sions of subpart A of this part apply to This substance may cause skin sen- this section except as modified by this sitization. This substance may cause paragraph. pulmonary sensitization. (1) Recordkeeping. Recordkeeping re- (iii) Industrial, commercial, and con- quirements as specified in § 721.125 (a) sumer activities. Requirements as speci- through (h) are applicable to manufac- fied in § 721.80(q). turers, importers, and processors of (iv) Release to water. Requirements as this substance. Manufacturers, import- specified in § 721.90 (a)(3), (b)(3), and ers, and processors who implement the (c)(3). product stewardship provisions or keep (b) Specific requirements. The provi- records as required by the section 5(e) sions of subpart A of this part apply to consent order for these substances are this section except as modified by this exempt from the requirements of paragraph. § 721.125. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a) notification requirements. The provisions through (i) and (k) are applicable to of § 721.185 apply to this section.

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(3) Applicability of § 721.5. The provi- (ii) Hazard communication program. sions of § 721.5 do not apply to manufac- Requirements as specified in § 721.72 (a), turers, importers, and processors, im- (b)(2), (c), (d), (e) (concentration set at plementing the product stewardship 0.1 percent), (f), (g)(1)(vii), (g)(2)(i), provisions in the section 5(e) consent (g)(2)(v), and (g)(5). order for these substances. (iii) Industrial, commercial, and consumer activities. Requirements as speci- [61 FR 63737, Dec. 2, 1996] fied in § 721.80(k). § 721.4500 Isopropylamine distillation (iv) Release to water. Requirements as residues and ethylamine distillation specified in § 721.90 (a)(2)(ii), (b)(2)(ii), residues. and (c)(2)(ii). (a) Chemical substances and significant (b) Specific requirements. The provi- new use subject to reporting. (1) The fol- sions of subpart A of this part apply to lowing chemical substances referred to this section except as modified by this by their Chemical Abstracts Service paragraph. (CAS) register numbers and chemical (1) Recordkeeping requirements. Re- names are subject to reporting under quirements as specified in § 721.125 (a) this section for the significant new use through (i), and (k) are applicable to identified in paragraph (a)(2) of this manufacturers, importers, and proc- section: CAS No. 79771–08–7, essors of this substance. isopropylamine distillation residues, (2) Limitations or revocation of certain and CAS No. 79771–09–98, ethylamine notification requirements. The provisions distillation residues. of § 721.185 apply to this section. (2) The significant new use is use in (3) Determining whether a specific use is metalworking fluids. subject to this section. The provisions of (b) Specific requirements. The provi- § 721.1725(b)(1) apply to this section. sions of subpart A of this part apply to [57 FR 44067, Sept. 23, 1992, as amended at 58 this section except as modified by this FR 29946, May 24, 1993; 58 FR 34204, June 23, paragraph. 1993] (1) Notice Requirements and Procedures. Section 721.10 applies to this section, § 721.4550 Diperoxy ketal. except persons submitting a notice (a) Chemical substance and significant must complete only Parts I and III of new uses subject to reporting. (1) The the notice form. chemical substance identified generi- (2) [Reserved] cally as diperoxy ketal (PMN–92–1394) (Sec. 5, Pub. L. 94–469, 90 Stat. 2012 (15 U.S.C. is subject to reporting under this sec- 2604)) tion for the significant new uses described in paragraph (a)(2) of this sec- [49 FR 46378, Nov. 26, 1984. Redesignated at 51 FR 23539, June 30, 1986, and 53 FR 2845, Feb. tion. 2, 1988. Further redesignated at 58 FR 29946, (2) The significant new uses are: (i) May 24, 1993, as amended at 58 FR 34204, June Hazard communication program. Re- 23, 1993] quirements as specified in § 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), and § 721.4520 Isopropylidene, bis(1,1- (g)(5). dimethylpropyl) derivative. (ii) Industrial, commercial, and con- (a) Chemical substance and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80(q). chemical substance identified as (iii) Release to water. Requirements as isopropylidene, bis(1,1-dimethylpropyl) specified in § 721.90 (a)(1), (b)(1), and derivative (PMN P-85–648) is subject to (c)(1). reporting under this section for the sig- (b) Specific requirements. The provi- nificant new uses described in para- sions of subpart A of this part apply to graph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Protection in the workplace. Re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.63 quirements as specified in § 721.125 (a), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3) (ap- (b), (c), (f), (g), (h), (i), and (k) are applies to gloves only), (b) (concentration plicable to manufacturers, importers, set at 0.1 percent), and (c). and processors of this substance.

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(2) Limitations or revocation of certain 91–1321 provide an impervious barrier notification requirements. The provisions to prevent dermal exposure during nor- of § 721.185 apply to this section. mal and expected duration and condi- (3) Determining whether a specific use is tions of exposure within the work area subject to this section. The provisions of by testing the material used to make § 721.1725(b)(1) apply to this section. the gloves and the construction of the gloves to establish that they will be [58 FR 51705, Oct. 4, 1993] impervious for the expected duration § 721.4565 Modified hydroxystyrene and conditions of exposure. The testing homopolymer (generic). must subject the gloves to the expected conditions of exposure, including the (a) Chemical substance and significant likely combinations of chemical sub- new uses subject to reporting. (1) The stances to which the gloves may be ex- chemical substance identified generi- posed in the work area. There must be cally as Modified hydroxystyrene no permeation of P-91–1321 greater than homopolymer (PMN P-99–0610) is sub- 0.017 mg/cm2/min after 8 h of testing in ject to reporting under this section for accordance with the most recent the significant new use described in versions of the American Society for paragraph (a)(2) of this section. Testing and Materials (ASTM) F739 (2) The significant new uses are: ‘‘Standard Test Method for Resistance (i) Industrial, commercial, and con- of Protective Clothing Materials to sumer activities. Requirements as speci- Permeation by Liquids or Gases’’ and fied in § 721.80(j). ASTM F1194 ‘‘Guide for Documenting (ii) [Reserved] the Results of Chemical Permeation (b) Specific requirements. The provi- Testing of Protective Clothing Mate- sions of subpart A of this part apply to rials.’’ The employer must submit all this section except as modified by this test data to the Agency and must re- paragraph. ceive written Agency approval of the (1) Recordkeeping. Recordkeeping re- test results for each type of glove test- quirements as specified in § 721.125 (a), ed prior to use of such gloves. Neoprene (b), (c), and (i) are applicable to manu- gloves with a minimum thickness of facturers, importers, and processors of 1.50 mm have already been tested and this substance. found to satisfy the terms of this rule. (2) Limitations or revocation of certain Nitrile gloves with a minimum thick- notification requirements. The provisions ness of 0.61 mm also satisfy the terms of § 721.185 apply to this section. of this rule, as long as the duration of (3) Determining whether a specific use is exposure to P-91–1321 is less than 2 h subject to this section. The provisions of per work shift. If the duration of expo- § 721.1725(b)(1) apply to this section. sure is longer than 2 h, nitrile gloves [65 FR 81401, Dec. 26, 2000] shall be discarded and replaced every 2 h. Unless otherwise indicated, gloves § 721.4568 Methylpolychloro aliphatic contaminated with P-91–1321 shall be ketone. disposed of after every work shift. (a) Chemical substance and significant (ii) Hazard communication program. new uses subject to reporting. (1) The Requirements as specified in § 721.72 (a), chemical substance identified generi- (b), (c), (d), (e) (concentration set at 0.1 cally as methylpolychloro aliphatic ke- percent), (f), (g)(1)(iii), (g)(1)(iv), tone (PMN No. P-91–1321) is subject to (g)(1)(v), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), reporting under this section for the sig- (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), nificant new uses described in para- and (g)(5). graph (a)(2) of this section. (iii) Industrial, commercial, and con- (2) The significant new uses are: sumer activities. Requirements as speci- (i) Protection in the workplace. Re- fied in § 721.80 (g) and (q). quirements as specified in § 721.63 (a)(1), (iv) Release to water. Requirements as (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), specified in § 721.90(a)(1), (b)(1), (c)(1). (a)(6)(ii), (a)(6)(iii), (a)(6)(v), (b) (con- (b) Specific requirements. The provi- centration set at 0.1 percent), and (c). sions of subpart A of this part apply to The employer is able to demonstrate this section except as modified by this that the gloves selected for handling P- paragraph.

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(1) Recordkeeping. Recordkeeping re- nificant new uses described in para- quirements as specified in § 721.125 (a), graph (a)(2) of this section. (b), (d) through (i), and (k) are applica- (2) The significant new uses are: ble to manufacturers, importers, and (i) Hazard communication program. Re- processors of this substance. quirements as specified in § 721.72 (a), (2) Limitations or revocation of certain (b), (c), (d), (f), (g)(3)(i), and (g)(3)(ii). notification requirements. The provisions (ii) Industrial, commercial, and con- of § 721.185 apply to this significant new sumer activities. Requirements as speci- use rule. fied in § 721.80(q). (3) Determining whether a specific use is (iii) Release to water. Requirements as subject to this section. The provisions of specified in § 721.90 (a)(4), (b)(4), and § 721.1725(b)(1) apply to this section. (c)(4) (where N = 10 ppb). (b) Specific requirements. The provi- [58 FR 32239, June 8, 1993, as amended at 58 FR 29946, May 24, 1993] sions of subpart A of this part apply to this section except as modified by this § 721.4575 L-aspartic acid, N,N′- [(1E) - paragraph. 1,2 - ethenediylbis[(3-sulfo-4, 1- (1) Recordkeeping. Recordkeeping re- phenylene)imino [6-(phenylamino)- quirements as specified in § 721.125 (a), 1,3,5-triazine- 4,2- diyl]]]bis-, (b), (c), (f), (g), (h), (i), and (k) are ap- hexasodium salt. plicable to manufacturers, importers, (a) Chemical substance and significant and processors of this substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified as l-as- notification requirements. The provisions partic acid, N,N′- [(1E) - 1,2 - of § 721.185 apply to this section. ethenediylbis[(3-sulfo-4, 1-phenylene) (3) Determining whether a specific use is imino[6-(phenylamino)-1,3,5-triazine- subject to this section. The provisions of 4,2-diyl]]]bis-, hexasodium salt (PMN § 721.1725(b)(1) apply to this section. P-99–1167; CAS No. 205764–98–3) is sub- [59 FR 27484, May 27, 1994] ject to reporting under this section for the significant new use described in § 721.4587 Lithium manganese oxide paragraph (a)(2) of this section. (LiMn204) (generic name). (2) The significant new uses are: (a) Chemical substance and significant (i) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified generi- fied in § 721.80 (v)(1), (w)(1), (x)(1), and cally as lithium manganese oxide (f). (LiMn204) (P-96–175) is subject to re- (ii) [Reserved] porting under this section for the sig- (b) Specific requirements. The provi- nificant new uses described in para- sions of subpart A of this part apply to graph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Hazard communication program. A (1) Recordkeeping. Recordkeeping re- significant new use of this substance is quirements as specified in § 721.125 (a), any manner or method of manufacture, (b), (c), and (i) are applicable to manu- import, or processing associated with facturers, importers, and processors of any use of these substances without this substance. providing risk notification as follows: (2) Limitations or revocation of certain (A) If as a result of the test data re- notification requirements. The provisions quired under the section 5(e) consent of § 721.185 apply to this section. order for these substances, the em- [68 FR 15085, Mar. 28, 2003] ployer becomes aware that these substances may present a risk of injury to § 721.4585 Lecithins, phospholipase A2- human health or the environment the hydrolyzed. employer must incorporate this new in- (a) Chemical substances and significant formation, and any information on new uses subject to reporting. (1) The methods for protecting against such chemical substances identified generi- risk, into a Material Safety Data Sheet cally as lecithins, phospholipase A2- (MSDS) as described in § 721.72(c) with- hydrolyzed (PMN P-93–333) is subject to in 90 days from the time the employer reporting under this section for the sig- becomes aware of the new information.

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If these substances are not being manu- (b) Specific requirements. The provi- factured, imported, processed, or used sions of subpart A of this part apply to in the employer’s workplace, the em- this section except as modified by this ployer must add the new information paragraph. to an MSDS before the substances are (1) Recordkeeping. Recordkeeping re- reintroduced into the workplace. quirements as specified in § 721.125 (a), (B) The employer must ensure that (b), (c), and (k) are applicable to manu- persons who will receive, or who have facturers, importers, and processors of received their substances from the em- this substance. ployer within 5 years from the date the (2) Limitations or revocation of certain employer becomes aware of the new in- notification requirements. The provisions formation described in paragraph of § 721.185 apply to this section. (a)(2)(i)(A) of this section, are provided an MSDS as described in § 721.72(c) con- [63 FR 3429, Jan. 22, 1998, as amended at 67 taining the information required under FR 12882, Mar. 20, 2002] paragraph (a)(2)(i)(A) of this section within 90 days from the time the em- § 721.4590 Mannich-based adduct. ployer becomes aware of the new infor- (a) Chemical substance and significant mation. new uses subject to reporting. (1) The (ii) Industrial, commercial, and con- chemical substance generically identi- sumer activities. Requirements as specified as a Mannich-based adduct (PMN fied in § 721.80(q). P-93–66) is subject to reporting under (b) Specific requirements. The provi- this section for the significant new sions of subpart A of this part apply to uses described in paragraph (a)(2) of this section except as modified by this this section. paragraph. (2) The significant new uses are: (i) (1) Recordkeeping. Recordkeeping re- Industrial, commercial, and consumer ac- quirements as specified in § 721.125 (a), tivities. Requirements as specified in (h), and (i) are applicable to manufac- § 721.80(h). turers, importers, and processors of these substances. (ii) Release to water. Requirements as (2) Limitations or revocation of certain specified in § 721.90 (a)(4), (b)(4), and notification requirements. The provisions (c)(4) (where N = 8 ppb). of § 721.185 apply to this section. (b) Specific requirements. The provi- (3) Determining whether a specific use is sions of subpart A of this part apply to subject to this section. The provisions of this section except as modified by this § 721.1725(b)(1) apply to this section. paragraph. (1) Recordkeeping. Recordkeeping re- [61 FR 63738, Dec. 2, 1996] quirements as specified in § 721.125 (a), § 721.4589 Propanedioic acid, [(4- (i), and (k) are applicable to manufac- methoxyphenyl)methylene]-, turers, importers, and processors of bis(1,2,2,6,6-pentamethyl-4- this substance. piperdinyl) ester (9CI). (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified as propanedioic acid, [(4- [58 FR 51705, Oct. 4, 1993] methoxyphenyl)methylene]-, § 721.4594 Substituted azo metal com- bis(1,2,2,6,6-pentamethyl-4-piperdinyl) plex dye. ester (9CI) (PMN P-95–1411; CAS No. 147783–69–5) is subject to reporting (a) Chemical substance and significant under this section for the significant new uses subject to reporting. (1) The new uses described in paragraph (a)(2) chemical substance identified generi- of this section. cally as a substituted azo metal com- (2) The significant new uses are: plex dye (PMN P-94–499) is subject to (i) Release to water. Requirements as reporting under this section for the sig- specified in § 721.90 (a)(1), (b)(1), and nificant new uses described in para- (c)(1). graph (a)(2) of this section. (ii) [Reserved] (2) The significant new uses are:

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(i) Industrial, commercial, and con- (i) Hazard communication program. A sumer activities. Requirements as speci- significant new use of this substance is fied in § 721.80(f). any manner or method of manufacture, (ii) [Reserved] import, or processing associated with (b) Specific requirements. The provi- any use of this substance without pro- sions of subpart A of this part apply to viding risk notification as follows: this section except as modified by this (A) If as a result of the test data re- paragraph. quired under the section 5(e) consent (1) Recordkeeping requirements. Rec- order for this substance, the employer ordkeeping requirements specified in becomes aware that this substance § 721.125 (a) and (i) are applicable to may present a risk of injury to the en- manufacturers, importers, and proc- vironment, the employer must incor- essors of this substance. porate this new information, and any (2) Limitations or revocation of certain information on methods for protecting notification requirements. The provisions against such risk, into an MSDS as de- of § 721.185 apply to this section. scribed in § 721.72(c) within 90 days from the time the employer becomes aware [60 FR 11044, Mar. 1, 1995] of the new information. If this sub- § 721.4596 Diazo substituted stance is not being manufactured, im- carbomonocyclic metal complex. ported, processed, or used in the employer’s workplace, the employer must (a) Chemical substance and significant add the new information to an MSDS new uses subject to reporting. (1) The before the substance is reintroduced chemical substance identified generi- into the workplace. cally as a diazo substituted (B) The employer must ensure that carbomonocyclic metal complex (PMN persons who will receive this substance P-94–1039) is subject to reporting under from the employer, or who have re- this section for the significant new ceived this substance from the em- uses described in paragraph (a)(2) of ployer within 5 years from the date the this section. employer becomes aware of the new in- (2) The significant new uses are: formation described under paragraph (i) Industrial, commercial, and con- (a)(2)(i)(A) of this section, are provided sumer activities. Requirements as speci- an MSDS as described in § 721.72(c) con- fied in § 721.80(f). taining the information required under (ii) [Reserved] paragraph (a)(2)(i)(A) of this section (b) Specific requirements. The provi- within 90 days from the time the em- sions of subpart A of this part apply to ployer becomes aware of the new infor- this section except as modified by this mation. paragraph. (ii) Industrial, commercial, and con- (1) Rec- Recordkeeping requirements. sumer activities. Requirements as speci- ordkeeping requirements specified in fied in § 721.80(q). § 721.125 (a) and (i) are applicable to (b) Specific requirements. The provi- manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping requirements. Re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), [60 FR 11044, Mar. 1, 1995] (h), and (i) are applicable to manufacturers, importers, and processors of § 721.4600 Recovered metal hydroxide. this substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance identified generi- of § 721.185 apply to this section. cally as a recovered metal hydroxide (3) Determining whether a specific use is (PMN P-91–809) is subject to reporting subject to this section. The provisions of under this section for the significant § 721.1725(b)(1) apply to this section. new uses described in paragraph (a)(2) [57 FR 44067, Sept. 23, 1992, as amended at 58 of this section. FR 29946, May 24, 1993; 58 FR 34204, June 23, (2) The significant new uses are: 1993]

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§ 721.4610 Mixed metal oxides (ge- new uses described in paragraph (a)(2) neric). of this section. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Hazard communication program. A chemical substance identified generi- significant new use of this substance is cally as mixed metal oxides (PMN P- any manner or method of manufacture, 98–0002) is subject to reporting under import, or processing associated with this section for the significant new use any use of this substance without pro- described in paragraph (a)(2) of this viding risk notification as follows. (A) section. If, as a result of the test data required (2) The significant new uses are: under the section 5(e) consent order for (i) Protection in the workplace. Re- this substance, the employer becomes quirements as specified in § 721.63 (a)(4), aware that this substance may present (a)(5)(i), (a)(6)(i), (b) (concentration set a risk of injury to human health, the at 0.1 percent), and (c). As an alter- employer must incorporate this new in- native to the respiratory requirements formation, and any information on listed here, a manufacturer, importer, methods for protecting against such or processor may choose to follow the risk, into a Material Safety Data Sheet NCEL provisions listed in the TSCA (MSDS) as described in § 721.72(c) with- 5(e) consent order for this substance. in 90 days from the time the employer The NCEL is 0.05 mg/m3 as an 8-hour becomes aware of the new information. time weighted average verified by ac- If this substance is not being manufac- tual monitoring data. tured, imported, processed, or used in (ii) Hazard communication program. the employer’s workplace, the em- Requirements as specified in § 721.72 (a), ployer must add the new information (b), (c), (d), (e) (concentration set at 0.1 to an MSDS before the substance is re- percent), (f) (g)(1)(ii), (g)(1)(vii), introduced into the workplace. (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv). (B) The employer must ensure that (iii) Industrial, commercial, and con- persons who have received, or will re- sumer activities. Requirements as speci- ceive, this substance from the em- fied in § 721.80(q). ployer are provided an MSDS as de- (b) Specific requirements. The provi- scribed in § 721.72(c) containing the in- sions of subpart A of this part apply to formation required under paragraph this section except as modified by this (a)(2)(i)(A) of this section within 90 paragraph. days from the time the employer be- (1) Recordkeeping. The following rec- comes aware of the new information. ordkeeping requirements are applicable (ii) Industrial, commercial, and con- to manufacturers, importers, and proc- sumer activities. Requirements as speci- essors of this substance, as specified in fied in § 721.80(p) (production limit set § 721.125 (a), (b), (c), (d), (f), (g), (h), and at 573,300 kg). (i). (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. (3) Determining whether a specific use is (1) Recordkeeping requirements. The subject to this section. The provisions of following recordkeeping requirements § 721.1725(b)(1) apply to this section. are applicable to manufacturers, im- [65 FR 81401, Dec. 26, 2000] porters, and processors of this substance, as specified in § 721.125 (a), (c), § 721.4620 Dialkylamino alkanoate (h), and (i). metal salt. (2) Limitations or revocation of certain (a) Chemical substances and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this significant new chemical substance identified generi- use rule. cally as dialkylamino alkanoate metal [56 FR 15789, Apr. 17, 1991. Redesignated at 58 salt (P-90–274), is subject to reporting FR 29946, May 24, 1993, as amended at 58 FR under this section for the significant 34204, June 23, 1993]

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§ 721.4660 Alcohol, alkali metal salt. (2) Limitations or revocation of certain notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The chemical substance generically identi- [61 FR 63738, Dec. 2, 1996] fied as alcohol, alkali metal salt (PMN P-91–151) is subject to reporting under § 721.4668 Hydrated alkaline earth this section for the significant new metal salts of metalloid oxyanions. uses described in paragraph (a)(2) of (a) Chemical substance and significant this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified as hy- (i) Release to water. Requirements as drated alkaline earth metal salts of specified in § 721.90 (a)(4), (b)(4), and metalloid oxyanions (PMN P-94–1557) is (c)(4) (N = 5 ppb). subject to reporting under this section (b) Specific requirements. The provi- for the significant new uses described sions of subpart A of this part apply to in paragraph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Protection in the workplace. Re- (1) Recordkeeping. The following rec- quirements as specified in § 721.63 (a)(4), ordkeeping requirements are applicable (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), to manufacturers, importers, and proc- (a)(5)(vii), (a)(5)(viii), (a)(6)(i), (b), and essors of this substance, as specified in (c). § 721.125 (a), (b), (c), and (k). (ii) Hazard communication program. (2) Limitations or revocation of certain Requirements as specified in § 721.72 (a), notification requirements. The provisions (b), (c), (d), (e), (f), (g)(1)(vi), (g)(1)(ix), of § 721.185 apply to this significant new (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5). use rule. (iii) Industrial, commercial, and con- [56 FR 40213, Aug. 13, 1991. Redesignated at 58 sumer activities. Requirements as speci- FR 29946, May 24, 1993, as amended at 58 FR fied in § 721.80(q). 34204, June 23, 1993] (b) Specific requirements. The provisions of subpart A of this part apply to § 721.4663 Fluorinated carboxylic acid this section except as modified by this alkali metal salts. paragraph. (a) Chemical substance and significant (1) Recordkeeping. Recordkeeping renew uses subject to reporting. (1) The quirements as specified in § 721.125 (a), chemical substances identified as (b), (c), (d), (f), (g), (h), and (i) are appli- fluorinated carboxylic acid alkali cable to manufacturers, importers, and metal salts (PMNs P-95–979/980/981) are processors of this substance. subject to reporting under this section (2) Limitations or revocation of certain for the significant new uses described notification requirements. The provisions in paragraph (a)(2) of this section. of § 721.185 apply to this section. (2) The significant new uses are: (3) Determining whether a specific use is (i) Industrial, commercial and consumer subject to this section. The provisions of activities. Requirements as specified in § 721.1725(b)(1) apply to this section. § 721.80 (v)(2), (w)(2), and (x)(2). (ii) Release to water. Requirements as [61 FR 63738, Dec. 2, 1996] specified in § 721.90 (a)(4), (b)(4), and (c)(4), (N = 100 ppb for P-95–979), (N = 30 § 721.4680 Metal salts of complex inor- ppb for P-95–980), and (N = 3 ppb for P- ganic oxyacids (generic name). 95–981). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substances identified generi- this section except as modified by this cally as metal salts of complex inor- paragraph. ganic oxyacids (PMNs P-89–576 and P- (1) Recordkeeping. Recordkeeping re- 89–577) are subject to reporting under quirements as specified in § 721.125 (a), this section for the significant new (b), (c), (i), and (k) are applicable to uses described in paragraph (a)(2) of manufacturers, importers, and proc- this section. essors of this substance. (2) The significant new uses are:

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(i) Industrial, commercial, and con- is subject to reporting under this sec- sumer activities. Requirements as speci- tion for the significant new uses de- fied in § 721.80(q). scribed in paragraph (a)(2) of this sec- (ii) [Reserved] tion. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Hazard communication program. Re- this section except as modified by this quirements as specified in § 721.72 paragraph. (b)(1)(i)(C), (b)(1)(ii), (b)(1)(iii), (1) Recordkeeping. The following rec- (b)(1)(iv), (b)(2), (c)(1), (f), (g)(3)(ii), ordkeeping requirements are applicable (g)(4)(i), and (g)(5). to manufacturers, importers, and proc- (ii) Industrial, commercial, and con- essors of this substance, as specified in sumer activities. Requirements as speci- § 721.125 (a), (b), (c), and (i). fied in § 721.80(j) (industrial coating ma- (2) Limitations or revocation of certain terial). notification requirements. The provisions (iii) Disposal. Requirements as speci- of § 721.185 apply to this significant new fied in § 721.85 (a)(1), (a)(3), (b)(1), (b)(3), use rule. (c)(1), and (c)(3). (3) Determining whether a specific use is (iv) Release to water. Requirements as subject to this section. The provisions of specified in § 721.90 (a)(3), (b)(3), and § 721.1725(b)(1) apply to this section. (c)(3). [55 FR 33305, Aug. 15, 1990. Redesignated and (b) Specific requirements. The provi- amended at 58 FR 29946, May 24, 1993; 58 FR sions of subpart A of this part apply to 34204, June 23, 1993] this section except as modified by this paragraph. § 721.4685 Substituted purine metal (1) Recordkeeping. The recordkeeping salt (generic name). requirements as specified in § 721.125 (a) (a) Chemical substance and significant through (k) are applicable to manufac- new uses subject to reporting. (1) The turers, importers, and processors of chemical substance identified generi- this substance. cally as a substituted purine metal salt (2) Limitations or revocation of certain (PMN P-95–175) is subject to reporting notification requirements. The provisions under this section for the significant of § 721.185 apply to this significant new new uses described in paragraph (a)(2) use rule. of this section. (2) The significant new uses are: [55 FR 32416, Aug. 9, 1990, as amended at 57 FR 20424, May 13, 1992. Redesignated at 58 FR (i) Release to water. Requirements as 29946, May 24, 1993, as amended at 58 FR specified in § 721.90 (a)(4), (b)(4), and 34204, June 23, 1993] (c)(4) (where N = 8) (ii) [Reserved] § 721.4720 Disubstituted phenoxazine, (b) Specific requirements. The provi- chlorometalate salt. sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified generi- (1) Recordkeeping. Recordkeeping re- cally as disubstituted phenoxazine, quirements as specified in § 721.125 (a), chlorometalate salt (PMN P-90–0002) is (b), (c), and (k) are applicable to manu- subject to reporting under this section facturers, importers, and processors of for the significant new uses described this substance. in paragraph (a)(2) of this section. (2) Limitations or revocation of certain (2) The significant new uses are: notification requirements. The provisions (i) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as speci- [61 FR 63739, Dec. 2, 1996] fied in § 721.80(g). (ii) [Reserved] § 721.4700 Metalated alkylphenol co- (b) Specific requirements. The provi- polymer (generic name). sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance metalated (1) Recordkeeping requirements. Re- alkylphenol copolymer (PMN P-87–723) quirements as specified in § 721.125 (a),

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(b), (c), and (i) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain [68 FR 15085, Mar. 28, 2003] notification requirements. The provisions of § 721.185 apply to this section. § 721.4794 Polypiperidinol-acrylate [57 FR 46467, Oct. 8, 1992, as amended at 58 FR methacrylate. 34204, June 23, 1993] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.4740 Alkali metal nitrites. chemical substance identified generi- (a) Chemical substances and significant cally as polypiperidinol-acrylate meth- new use subject to reporting. (1) The cat- acrylate (PMN P-88–1304) is subject to egory of chemical substances which are reporting under this section for the sig- nitrites of the alkali metals (Group IA nificant new uses described in para- in the periodic classification of chem- graph (a)(2) of this section. ical elements) lithium, sodium, potas- (2) The significant new uses are: sium, rubidium, cesium, and francium, (i) Protection in the workplace. Re- is subject to reporting under this sec- quirements as specified in § 721.63 (a)(1), tion for the significant new use de- (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), scribed in paragraph (a)(2) of this sec- (a)(5)(iii), (a)(6)(i), (b) (concentration tion. set at 1.0 percent), and (c). (2) The significant new use is: Use as (ii) Hazard communication program. an ingredient in metalworking fluids Requirements as specified in § 721.72 (a), (as defined in 40 CFR 721.3) containing (b), (c), (d), (e) (concentration set 1.0 amines. percent), (f), (g)(1)(vi), (g)(1)(viii), (b) [Reserved] (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v). The following additional statement [58 FR 27944, May 12, 1993, as amended at 58 shall appear on each label and MSDS FR 34204, June 23, 1993] required by this paragraph: This sub- § 721.4792 2-propenoic acid, 2-methyl-, stance may cause acute and chronic toxicity. C11-14-isoalkyl esters, C13-rich. (iii) Industrial, commercial, and con- (a) Chemical substance and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80 (l) and (q). chemical substance identified as 2-pro- (b) Specific requirements. The provi- penoic acid, 2-methyl-, C -isoalkyl 11-14 sions of subpart A of this part apply to esters, C -rich (PMN P-99–1189; CAS 13 this section except as modified by this No. 85736–97–6) is subject to reporting paragraph. under this section for the significant (1) Recordkeeping. Recordkeeping renew use described in paragraph (a)(2) of quirements as specified in § 721.125 (a) this section. through (i) are applicable to manufac- (2) The significant new uses are: turers, importers, and processors of (i) Industrial, commercial, and con- this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(j) (a monomer for cast- notification requirements. The provisions ing automotive parts adhesives or im- of § 721.185 apply to this section. pregnation fluid). (ii) Release to water. Requirements as [59 FR 27484, May 27, 1994] specified in § 721.90(c)(4) (N=1 ppb). (b) Specific requirements. The provi- § 721.4820 Methane, bromodifluoro-. sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified as meth- (1) Recordkeeping. Recordkeeping re- ane, bromodifluoro- is subject to requirements as specified in § 721.125 (a), porting under this section for the sig- (b), (c), (i), and (k) are applicable to nificant new uses described in para- manufacturers, importers, and proc- graph (a)(2) of this section. essors of this substance. (2) The significant new uses are:

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(i) Hazard communication program. Re- (3) Determining whether a specific use is quirements as specified in § 721.72 (a), subject to this section. The provisions of (b), (c), (d), (e) (concentration set at 0.1 § 721.1725(b)(1) apply to this section. percent), (f), (g)(1)(iv), (g)(1)(v), [56 FR 19238, Apr. 25, 1991. Redesignated and (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(ii), amended at 58 FR 29946, May 24, 1993; 58 FR (g)(2)(iii), and (g)(5). In addition, the 34204, June 23, 1993; 59 FR 39296, Aug. 2, 1994] following statements shall appear on the label and MSDS: This substance § 721.4840 Substituted triphenylmethane. may cause cardiotoxicity. Evacuate area before the concentration of this (a) Chemical substance and significant substance in the area reaches 1 per- new uses subject to reporting. (1) The cent. Residential use is prohibited due chemical substance identified generically as a substituted to cardiotoxic dangers. General con- triphenylmethane (PMN P-87–1553) is sumer use is prohibited, with the ex- subject to reporting under this section ception of outdoor automotive use and for the significant new uses described outdoor marine use. Following dis- in paragraph (a)(2) of this section. charge and evacuation, use protective (2) The significant new uses are: gear (self-contained breathing appa- (i) Industrial, commercial, and con- ratus) before reentering an area in sumer activities. Requirements as speci- which the airborne concentration of fied in § 721.80 (v)(1), (w)(1), (x)(1) and the PMN substance exceeds 1 percent. (y)(2). (ii) Industrial, commercial, and con- (ii) [Reserved] sumer activities. Requirements as speci- (b) Specific requirements. The provi- fied in § 721.80(k) (Use in portable fire sions of subpart A of this part apply to extinguishers intended for consumer this section except as modified by this use except for outdoor automotive use paragraph. and outdoor marine use; use in fire ex- (1) Recordkeeping. The following rec- tinguisher units with an Underwriters ordkeeping requirements are applicable Laboratory (UL) rating of less than to manufacturers, importers, and proc- 5BC; use in other than rechargeable essors of this substance, as specified in § 721.125 (a), (b), (c), and (i). fire extinguisher units; use in occupied (2) Limitations or revocation of certain areas from which personnel cannot be notification requirements. The provisions evacuated before the concentration of of § 721.185 apply to this significant new the PMN substance exceeds 1 percent use rule. or egress cannot occur within 30 seconds; or use without protective gear [56 FR 40216, Aug. 13, 1991. Redesignated at 58 (self-contained breathing apparatus) FR 29947, May 24, 1993, as amended at 58 FR 34204, June 23, 1993] being made available in the event that, following discharge of the PMN sub- § 721.4880 Methanol, trichloro-, car- stance and evacuation of the area, per- bonate (2:1). sonnel must reenter an area in which (a) Chemical substance and significant the airborne concentration of the PMN new uses subject to reporting. (1) The substance exceeds 1 percent.) chemical substance identified as meth- (b) Specific requirements. The provi- anol, trichloro-, carbonate (2:1) (CAS sions of subpart A of this part apply to No. 32315–10–9) (PMN P-90–1535) is sub- this section except as modified by this ject to reporting under this section for paragraph. the significant new uses described in (1) Recordkeeping. The following rec- paragraph (a)(2) of this section. ordkeeping requirements are applicable (2) The significant new uses are: to manufacturers, importers, and proc- (i) Hazard communication program. Re- essors of this substance, as specified in quirements as specified in § 721.72 (a), § 721.125 (a) through (c), (f) through (i). (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(i), (g)(1)(ii), (2) Limitations or revocation of certain (g)(1)(iii), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), notification requirements. The provisions (g)(2)(iii), (g)(5). The following addi- of § 721.185 apply to this significant new tional human hazard precautionary use rule. statement shall appear on the label:

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This substance may react to form phos- (iii) Industrial, commercial, and con- gene gas. When using this substance, sumer activities. Requirements as speci- handle with extreme caution. fied in § 721.80(q). (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section. paragraph. (1) Recordkeeping. The following rec- (1) Recordkeeping. Recordkeeping re- ordkeeping requirements are applicable quirements as specified in § 721.125 (a), to manufacturers, importers, and proc- (b), (c), (d), (f), (g), (h), and (i) are appli- essors of this substance, as specified in cable to manufacturers, importers, and § 721.125 (a), (b), (c), (f), (g), and (h). processors of this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this significant new of § 721.185 apply to this section. use rule. (3) Determining whether a specific use is [56 FR 40213, Aug. 13, 1991. Redesignated at 58 subject to this section. The provisions of FR 29946, May 24, 1993, as amended at 58 FR § 721.1725(b)(1) apply to this section. 34204, June 23, 1993] [63 FR 3430, Jan. 22, 1998]

§ 721.4885 Methanone, [5-[[3-(2H- § 721.4925 Methyl n-butyl ketone. benzotriazol-2-yl)-2-hydroxy-5- (1,1,3,3- (a) Chemical substance and significant tetramethylbutyl)phenyl]methyl]-2- new use subject to reporting. (1) The hydroxy-4-(octyloxy) phenyl]phenyl- chemical substance methyl n-butyl ke- . tone, CAS Number 591–78–6, is subject (a) Chemical substance and significant to reporting under this section for the new uses subject to reporting. (1) The significant new use described in para- chemical substance identified as graph (a)(2) of this section. methanone, [5-[[3-(2H-benzotriazol-2- (2) The significant new use is any yl)-2-hydroxy-5-(1,1,3,3- use. tetramethylbutyl)phenyl]methyl]-2-hy- (b) Specific requirements. The provi- droxy-4-(octyloxy)phenyl]phenyl- sions of subpart A of this part apply to (PMN P-96–942; CAS No.162245–07–0) is this section except as modified by this subject to the reporting under this sec- paragraph. tion for the significant new uses de- (1) Persons who must report. Section scribed in paragraph (a)(2) of this sec- 721.5 applies to this section except for tion. § 721.5(a)(2). A person who intends to (2) The significant new uses are: manufacture, import, or process for (i) Protection in the workplace. Re- commercial purposes the substance quirements as specified in § 721.63 (a)(4), identified in paragraph (a)(1) of this (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), section and intends to distribute the (a)(6)(i), (b) (concentration set at 1.0 substance in commerce must submit a percent), and (c). As an alternative to significant new use notice. the respiratory protection require- (2) [Reserved] ments of this section, manufacturers, [52 FR 11825, Apr. 13, 1987. Redesignated at 53 importers, and processors of this sub- FR 2845, Feb. 2, 1988. Further redesignated at stance may follow the terms of the new 58 FR 29946, May 24, 1993, as amended at 58 chemical exposure limits section in the FR 34204, June 23, 1993] TSCA section 5(e) consent order for this substance. § 721.5050 2,2′-[(1-Methyl- (ii) Hazard communication program. ethylidene)bis[4,1-phenyloxy[1- Requirements as specified in § 721.72 (a), (butoxymethyl)-(2,1-ethan- (b), (c), (d), (e) (concentration set at 1.0 ediyl]oxymethylene]]bisoxirane, re- percent), (f), (g)(1)(i), (g)(1)(iv), action product with a diamine. (g)(1)(vi), (g)(1)(viii), (g)(2)(ii), (g)(2)(iv), (a) Chemical substance and significant and (g)(5). new uses subject to reporting. (1) The

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chemical substance identified generi- (v) Release to water. Requirements as cally as 2,2′-[(1-methylethyli- specified in § 721.90(a)(4) (where N = 2 dene)bis[4,1-phenyloxy[1-(butoxy- ppb). methyl)-(2,1-ethane- (b) Specific requirements. The provi- diyl]oxymethylene]]bisoxirane, reac- sions of subpart A of this part apply to tion product with a diamine (PMN P- this section except as modified by this 91–934), is subject to reporting under paragraph. this section for the significant new (1) Recordkeeping. Recordkeeping re- uses described in paragraph (a)(2) of quirements as specified in § 721.125 (a), this section. (b), (c), (f) through (k) are applicable to (2) The significant new uses are: manufacturers, importers, and proc- (i) Release to water. Requirements as essors of this substance. specified in § 721.90 (a)(1), (b)(1), and (2) Limitations or revocation of certain (c)(1). notification requirements. The provisions (ii) [Reserved] of § 721.185 apply to this section. (b) Specific requirements. The provi- (3) Determining whether a specific use is sions of subpart A of this part apply to subject to this section. The provisions of this section except as modified by this § 721.1725(b)(1) apply to this section. paragraph. [58 FR 51685, Oct. 4, 1993] (1) Recordkeeping requirements. Re- quirements as specified in § 721.125 (a), § 721.5175 Mitomycin C. (b), (c), and (k) are applicable to manu- (a) Chemical substance and significant facturers, importers, and processors of new use subject to reporting. (1) The this substance. chemical substance mitomycin C (CAS (2) Limitations or revocation of certain No. 5007–7) is subject to reporting under notification requirements. The provisions this section for the significant new use of § 721.185 apply to this section. described in paragraph (a)(2) of this [57 FR 46467, Oct. 8, 1992, as amended at 58 FR section. 34204, June 23, 1993] (2) The significant new use is: Manu- facture, import, or processing of 10,000 § 721.5075 Mixed methyltin pounds or more per year per facility for mercaptoester sulfides. any use. (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance generically identi- this section except as modified by this fied as mixed methyltin mercaptoester paragraph. sulfides (PMN P-92–177) is subject to re- (1) Recordkeeping. The following rec- porting under this section for the sig- ordkeeping requirements are applicable nificant new uses described in para- to manufacturers, importers, and proc- graph (a)(2) of this section. essors of this substance, as specified in (2) The significant new uses are: § 721.125 (a), (b), and (c). (i) Hazard communication program. Re- (2) [Reserved] quirements as specified in § 721.72 (a), [58 FR 63517, Dec. 1, 1993] (b), (c), (d), (f), (g)(1)(i), (g)(1)(iii), (g)(1)(iv), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), § 721.5185 2-Propen-1-one, 1-(4- (g)(2)(iii), (g)(3)(i), (g)(3)(ii), (g)(4)(i), morpholinyl)-. and (g)(5). (a) Chemical substance and significant (ii) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified as 2- fied in § 721.80(q). Propen-1-one, 1-(4-morpholinyl)-(PMN (iii) Disposal. Requirements as speci- P–95–169; CAS No. 5117–12–4) is subject fied in § 721.85 (a)(1) and (a)(2) (only in to reporting under this section for the a facility permitted to landfill Re- significant new uses described in para- sources Conservation and Recovery Act graph (a)(2) of this section. The re- (RCRA) hazardous wastes with the quirements of this rule do not apply to landfill operated in accordance with quantities of the PMN substance after subtitle C of RCRA). it has been completely reacted (cured). (iv) [Reserved] (2) The significant new uses are:

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(i) Protection in the workplace. Re- § 721.5192 Substituted 1,6-dihydroxy quirements as specified in § 721.63 (a)(1), naphthalene. (a)(2)(i), (a)(2)(iv), (a)(3)(i), (a)(3)(ii), (a) Chemical substance and significant (a)(4), (a)(6)(v), (b) (concentration set new uses subject to reporting. (1) The at 1.0 percent), and (c). Safety 4/4H chemical substance identified generi- EVOH/PE laminate, Ansell Edmont Ne- cally as substituted 1,6-dihydroxy oprene number 865, and Solvex Nitrile naphthalene (PMN P-87–1036) is subject Rubber number 275 gloves have been to reporting under this section for the tested in accordance with the Amer- significant new uses described in para- ican Society for Testing Materials graph (a)(2) of this section. (ASTM) F739 method and found by EPA (2) The significant new uses are: to satisfy the consent orders and (i) Protection in the workplace. Re- § 721.63(a)(2)(i) requirements for dermal quirements as specified in § 721.63 (a)(1), protection to 100 percent PMN sub- (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), (b) stance. Gloves and other dermal pro- (concentration set at 0.1 percent), and tection may not be used for a time pe- (c). riod longer than they are actually test- (ii) Hazard communication program. ed and must be replaced at the end of Requirements as specified in § 721.72 (a), each work shift. For additional dermal (b), (c), (d), (e) (concentration set at 0.1 protection materials, a company must percent), (f), (g)(1)(vi), (g)(1)(vii), submit all test data to the Agency and (g)(2)(i), (g)(2)(v), and (g)(5). must receive written Agency approval (iii) Industrial, commercial, and con- for each type of material tested prior sumer activities. Requirements as speci- to use of that material as worker der- fied in § 721.80 (f), (k), and (q). mal protection. However, for the pur- (iv) Disposal. Requirements as speci- poses of determining the impervious- fied in § 721.85 (a)(1) and (a)(2). ness of gloves, up to 1 year after the (v) Release to water. Requirements as commencement of commercial manu- specified in § 721.90(a)(3). facture or import, the employer may (b) Specific requirements. The provi- use the method described in sions of subpart A of this part apply to § 721.63(a)(3)(ii), thereafter, they must this section except as modified by this use the method described in paragraph. § 721.63(a)(3)(i). (1) Recordkeeping. Recordkeeping re- (ii) Hazard communication program. quirements as specified in § 721.125 (a) through (k) are applicable to manufac- Requirements as specified in § 721.72 (a), turers, importers, and processors of (b), (c), (d), (e) (concentration set at 1.0 this substance. percent), (f), (g)(1)(iv), (g)(1)(vi), (2) Limitations or revocation of certain (g)(2)(v), and (g)(5). notification requirements. The provisions (iii) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as speci- (3) Determining whether a specific use is fied in § 721.80 (a), (c), and (y)(1). subject to this section. The provisions of (b) Specific requirements. The provi- § 721.1725(b)(1) apply to this section. sions of subpart A of this part apply to this section except as modified by this [60 FR 45083, Aug. 30, 1995] paragraph. § 721.5200 Disubstituted phenylazo (1) Recordkeeping. Recordkeeping re- trisubstituted naphthalene. quirements as specified in § 721.125 (a) through (i) are applicable to manufac- (a) Chemical substance and significant turers, importers, and processors of new uses subject to reporting. (1) The this chemical substance. chemical substance identified generically as disubstituted phenylazo (2) Limitations or revocation of certain trisubstituted naphthalene (PMN P-91– notification requirements. The provisions 328) is subject to reporting under this of § 721.185 apply to this section. section for the significant new uses de- [65 FR 371, Jan. 5, 2000, as amended at 76 FR scribed in paragraph (a)(2) of this sec- 27914, May 13, 2011] tion. (2) The significant new uses are:

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(i) Industrial, commercial, and con- of § 721.185 apply to this significant new sumer activities. Requirements as speci- use rule. fied in § 721.80 (g), (v)(1), (w)(1), (x)(1), (3) Determining whether a specific use is and (y)(2). subject to this section. The provisions of (ii) [Reserved] § 721.1725(b)(1) apply to this section. (b) Specific requirements. The provi- [55 FR 26110, June 26, 1990. Redesignated and sions of subpart A of this part apply to amended at 58 FR 29946, 29947, May 24, 1993; 58 this section except as modified by this FR 34204, June 23, 1993; 62 FR 42692, Aug. 8, paragraph. 1997] (1) Recordkeeping requirements. Re- quirements as specified in § 721.125 (a), § 721.5250 Trimethyl (b), (c), and (i) are applicable to manu- spiropolyheterocyclic naphthalene compound. facturers, importers, and processors of this substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance identified generi- of § 721.185 apply to this section. cally as trimethyl spiropolyheterocyclic naphthalene compound (PMN P-91– [57 FR 46467, Oct. 8, 1992, as amended at 58 FR 1456) is subject to reporting under this 34204, June 23, 1993] section for the significant new uses described in paragraph (a)(2) of this sec- § 721.5225 Naphthalene,1,2,3,4-tetra- tion. hydro(1-phenylethyl) (specific name). (2) The significant new uses are: (i) Release to water. Requirements as (a) Chemical substance and significant specified in § 721.90 (a)(1), (b)(1), and new uses subject to reporting. (1) The (c)(1). chemical substance naphthalene,1,2,3,4- (ii) [Reserved] tetrahydro(1-phenylethyl) (PMN P-85– (b) Specific requirements. The provi- 1331) is subject to reporting under this sions of subpart A of this part apply to section for the significant new uses de- this section except as modified by this scribed in paragraph (a)(2) of this sec- paragraph. tion. (1) Recordkeeping requirements. Rec- (2) The significant new uses are: ordkeeping requirements as specified (i) Hazard communication program. Re- at § 721.125 (a), (b), (c), and (k) are appli- quirements as specified in § 721.72 (b)(2), cable to manufacturers, importers, and (c), (e) [concentration set at 1.0 per- processors of this substance. cent], (f), and (g)(3)(i) and (g)(3)(ii), (2) Limitations or revocation of certain (g)(4)(i) and (g)(4)(iii), and (g)(5). notification requirements. The provisions (ii) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as specified in § 721.80(k). [57 FR 31968, July 20, 1992, as amended at 58 FR 34204, June 23, 1993] (iii) Disposal. Requirements as specified in § 721.85 (a) (1) and (2), (b)(1) and § 721.5252 2-Naphthalenecarboxylic (b)(2), and (c)(1) and (c)(2). acid, 4,4′-methylenebis [3-hydroxy-, (iv) [Reserved] zinc salt. (v) Release to water. Requirements as (a) Chemical substance and significant specified in § 721.90 (a)(4), (b)(4), and new uses subject to reporting. (1) The (c)(4) (where n = 1). chemical substance identified as 2- (b) Specific requirements. The provi- Naphthalenecarboxylic acid, 4,4′- sions of subpart A of this part apply to methylenebis [3-hydroxy-, zinc salt (P- this section except as modified by this 99–1342; CAS No. 235083–88–2) is subject paragraph. to reporting under this section for the (1) Recordkeeping. The following rec- significant new uses described in para- ordkeeping requirements are applicable graph (a)(2) of this section. to manufacturers, importers, and proc- (2) The significant new uses are: essors of this substance, as specified in (i) Release to water. Requirements as § 721.125 (a) through (k). specified in § 721.90(a)(4), (b)(4), and (2) Limitations or revocation of certain (c)(4) (N=10). notification requirements. The provisions (ii) [Reserved]

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(b) Specific requirements. The provi- (c)(4) (where N = 1). When calculating sions of subpart A of this part apply to the surface water concentrations ac- this section except as modified by this cording to the instructions in § 721.91, paragraph. the statement that the amount of the (1) Recordkeeping. Record keeping re- substance that will be released will be quirements as specified in § 721.125(a), calculated before the substance enters (b), (c), and (k) are applicable to manu- control technology does not apply. In- facturers, importers, and processors of stead, if the waste stream containing this chemical substance. the substance will be treated before re- (2) Limitations or revocation of certain lease, then the amount of the sub- notification requirements. The provisions stance reasonably likely to be removed of § 721.185 apply to this section. from the waste stream by such treat- [68 FR 70177, Dec. 17, 2003] ment may be subtracted in calculating the number of kilograms released. No § 721.5253 2-Naphthalenecarboxylic more than 90 percent removal effi- acid, 4,4′-methylenebis [3-hydroxy-, ciency may be attributed to such treat- strontium salt. ment. (a) Chemical substance and significant (ii) [Reserved] new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substance identified as 2- sions of subpart A of this part apply to Naphthalenecarboxylic acid, 4,4′- this section except as modified by this methylenebis [3-hydroxy-, strontium paragraph. salt (PMN P-99–1341; CAS No. 235083–90– (1) Recordkeeping. Recordkeeping re- 6) is subject to reporting under this quirements as specified in § 721.125 (a), section for the significant new uses de- (b), (c), and (k) are applicable to manu- scribed in paragraph (a)(2) of this sec- facturers, importers, and processors of tion. this substance. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Release to water. Requirements as notification requirements. The provisions specified in § 721.90(a)(4), (b)(4), and of § 721.185 apply to this section. (c)(4) (N=10). (ii) [Reserved] [63 FR 3430, Jan. 22, 1998] (b) Specific requirements. The provi- § 721.5260 1,3,6-Naphthalenetrisulfonic sions of subpart A of this part apply to acid, 7-[[2-[(aminocarbonyl)amino]- this section except as modified by this 4-[[4-[[2-[2-(ethenylsulfonyl)ethoxy] paragraph. ethyl]amino]- 6-fluoro-1,3,5-triazin- (1) Recordkeeping. Record keeping re- 2-yl]amino]phenyl]azo], trisodium quirements as specified in § 721.125(a), salt. (b), (c), and (k) are applicable to manu- (a) Chemical substance and significant facturers, importers, and processors of new uses subject to reporting. (1) The this chemical substance. chemical substance identified as 1,3,6- (2) Limitations or revocation of certain Naphthalenetrisulfonic acid, 7-[[2- notification requirements. The provisions [(aminocarbonyl)amino]-4-[[4-[[2-[2- of § 721.185 apply to this section. (ethenylsulfonyl)ethoxy]ethyl]amino]- [68 FR 70177, Dec. 17, 2003] 6-fluoro-1,3,5-triazin-2- yl]amino]phenyl]azo], trisodium salt § 721.5255 2-Naphthalenol, mono and (PMN P-00–0806; CAS No. 106359–91–5) is dioctyl derivs. subject to reporting under this section (a) Chemical substance and significant for the significant new use described in new uses subject to reporting. (1) The paragraph (a)(2) of this section. chemical substance identified as 2- (2) The significant new uses are: naphthalenol, mono and dioctyl derivs (i) Industrial, commercial, and con- (PMN P-95–1288) is subject to reporting sumer activities. Requirements as speci- under this section for the significant fied in § 721.80(f). new uses described in paragraph (a)(2) (ii) [Reserved] of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified in § 721.90 (a)(4), (b)(4), and paragraph.

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(1) Recordkeeping. Recordkeeping re- (i) Protection in the workplace. Re- quirements as specified in § 721.125 (a), quirements as specified in § 721.63 (a)(4), (b), (c), and (i) are applicable to manu- (a)(5)(iii) through (a)(5)(vii), and facturers, importers, and processors of (a)(6)(i), (b) [concentration set at 0.1 this substance. percent], and (c). (2) Limitations or revocation of certain (ii) Hazard communication program. notification requirements. The provisions Requirements as specified in § 721.72 (a), of § 721.185 apply to this section. (b), (c), (d), (e) [concentration set at 0.1 percent], (f), and (g)(1)(i), (g)(1)(v), and [68 FR 15085, Mar. 28, 2003] (g)(1)(vii), and (g)(2)(ii) and (g)(2)(iv). (iii) Industrial, commercial, and con- § 721.5262 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[substituted] sumer activities. Requirements as speci- amino]-1,3,5-triazin-2-yl]amino]-4- fied in § 721.80(k). hydroxy-3-[(1-sulfo-2- (b) Specific requirements. The provi- naphthalenyl)azo]-, trisodium salt sions of subpart A of this part apply to (generic). this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping. The following rec- chemical substance identified generi- ordkeeping requirements are applicable cally as 2,7-Naphthalenedisulfonic acid, to manufacturers, importers, and proc- 5-[[4-chloro-6-[substituted] amino]- essors of this substance, as specified in 1,3,5-triazin-2-yl]amino]-4-hydroxy-3- § 721.125 (a) through (i). [(1-sulfo-2-naphthalenyl)azo]-, tri- (2) Limitations or revocation of certain sodium salt (PMN P-00–0803) is subject notification requirements. The provisions to reporting under this section for the of § 721.185 apply to this significant new significant new use described in para- use rule. graph (a)(2) of this section. (3) Determining whether a specific use is (2) The significant new uses are: subject to this section. The provisions of (i) Industrial, commercial, and con- § 721.1725(b)(1) apply to this section. sumer activities. Requirements as speci- [55 FR 26110, June 26, 1990. Redesignated and fied in § 721.80(f). amended at 58 FR 29946, 29947, May 24, 1993; 58 (ii) [Reserved] FR 34204, June 23, 1993] (b) Specific requirements. The provisions of subpart A of this part apply to § 721.5276 2-Naphthalenol, heptyl-1- [[(4-phenylazo)phenyl]azo]-, ar′,ar″- this section except as modified by this Me derivs. paragraph. (1) Recordkeeping. Recordkeeping re- (a) Chemical substance and significant quirements as specified in § 721.125 (a), new uses subject to reporting. (1) The (b), (c), and (i) are applicable to manu- chemical substance identified as 2- naphthalenol, heptyl-1-[[(4- facturers, importers, and processors of ′ ″ this substance. phenylazo)phenyl] azo]-, ar ,ar -Me derivs (PMN P-95–538) is subject to re- (2) Limitations or revocation of certain porting under this section for the sig- notification requirements. The provisions nificant new uses described in para- of § 721.185 apply to this section. graph (a)(2) of this section. [68 FR 15085, Mar. 28, 2003] (2) The significant new uses are: (i) Industrial, commercial, and con- § 721.5275 2-Napthalenecarboxamide- sumer activities. Requirements as speci- N-aryl-3-hydroxy-4-arylazo (generic fied in § 721.80 (v)(1), (w)(1), and (x)(1). name). (ii) [Reserved] (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance 2-naphthalenecar- this section except as modified by this boxamide-N-aryl-3-hydroxy-4-arylazo paragraph. (PMN P-87–1265) is subject to reporting (1) Recordkeeping. Recordkeeping re- under this section for the significant quirements as specified in § 721.125(a), new uses described in paragraph (a)(2) (b), (c), and (i) are applicable to manu- of this section. facturers, importers, and processors of (2) The significant new uses are: this substance.

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(2) Limitations or revocation of certain fied in § 721.80 (f), (v)(1), (w)(1), and notification requirements. The provisions (x)(1). of § 721.185 apply to this section. (ii) Release to water. Requirements as [61 FR 63739, Dec. 2, 1996] specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 40). § 721.5278 Substituted (b) Specific requirements. The provi- naphthalenesulfonic acid, alkali sions of subpart A of this part apply to salt. this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping. Recordkeeping re- chemical substance identified generi- quirements as specified in § 721.125 (a), cally as a substituted (b), (c), (i), and (k) are applicable to naphthalenesulfonic acid, alkali salt manufacturers, importers, and proc- (PMN P-95–85) is subject to reporting essors of this substance. under this section for the significant (2) Limitations or revocation of certain new uses described in paragraph (a)(2) notification requirements. The provisions of this section. of § 721.185 apply to this section. (2) The significant new uses are: [63 FR 3430, Jan. 22, 1998] (i) Industrial, commercial, and consumer activities. Requirements as speci- § 721.5280 2,7-Naphthalenedisulfonic fied in § 721.80(f). acid, 4-amino-5-hydroxy-, coupled (ii) [Reserved] with diazotized 4- (b) Specific requirements. The provi- butylbenzenamine, diazotized 4,4′- sions of subpart A of this part apply to cyclohexylidenebis[benzenamine] this section except as modified by this and m-phenylenediamine, sodium paragraph. salt. (1) Recordkeeping. Recordkeeping re- (a) Chemical substance and significant quirements as specified in § 721.125 (a) new uses subject to reporting. (1) The and (i) are applicable to manufactur- chemical substance identified as 2,7- ers, importers, and processors of this naphthalenedisulfonic acid, 4-amino-5- substance. hydroxy-, coupled with diazotized 4- (2) Limitations or revocation of certain butylbenzenamine, diazotized 4,4′- notification requirements. The provisions cyclohexyl-idenebis[benzenamine] and of § 721.185 apply to this section. m-phenylenediamine, sodium salt (PMN P-97–193; CAS No. 182238–09–1) is [60 FR 45083, Aug. 30, 1995] subject to reporting under this section § 721.5279 2,7-Naphthalenedisulfonic for the significant new uses described acid, 4-amino-3-[[4′2-amino-4-[(3-but- in paragraph (a)(2) of this section. oxy-2- (2) The significant new uses are: hydroxypropyl)amino]phebyl]azo]- (i) Industrial, commercial, and con- 3,3′-dimethyl[1,1′-biphenyl]-4- sumer activities. Requirements as speci- yl]azo]-5-hydroxy-6-(phenylazo)-, di- fied in § 721.80 (f), (v)(1), (w)(1), and sodium salt. (x)(1). (a) Chemical substance and significant (ii) [Reserved] new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substance identified as 2,7- sions of subpart A of this part apply to naphthalenedisulfonic acid, 4-amino-3- this section except as modified by this ′ [[4 2-amino-4-[(3-butoxy-2- paragraph. hydroxypropyl)amino]phebyl]azo]-3,3′- (1) Recordkeeping. Recordkeeping re- dimethyl[1,1′-biphenyl]-4-yl]azo]-5-hy- quirements as specified in § 721.125 (a), droxy-6-(phenylazo)-, disodium salt (b), (c), and (i) are applicable to manu- (PMN P-97–131; CAS No. 103580–64–9) is facturers, importers, and processors of subject to reporting under this section this substance. for the significant new uses described in paragraph (a)(2) of this section. (2) Limitations or revocation of certain notification requirements. The provisions (2) The significant new uses are: of § 721.185 apply to this section. (i) Industrial, commercial, and consumer activities. Requirements as speci- [63 FR 3430, Jan. 22, 1998]

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§ 721.5281 2-Naphthalenesulfonic acid, (i) Industrial, commercial, and con- 3-[[4-[(2,4-dimethyl-6- sumer activities. Requirements as speci- sulfophenyl)azo]-2-methoxy-5- fied in § 721.80(f). methylphenyl]azo]-4-hydroxy-7- (ii) [Reserved] (phenylamino)-, sodium salt, compd. ′ ″ (b) Specific requirements. The provi- With 2,2 ,2 -nitrilotris [ethanol] sions of subpart A of this part apply to (9CI). this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping. Recordkeeping re- chemical substance identified as 2- quirements as specified in § 721.125 (a) Naphthalenesulfonic acid, 3-[[4-[(2,4-di- and (i) are applicable to manufactur- methyl-6-sulfophenyl)azo]-2-methoxy-5- ers, importers, and processors of this methylphenyl]azo]-4-hydroxy-7- substance. (phenylamino)-, sodium salt, compd. (2) Limitations or revocation of certain With 2,2′,2″-nitrilotris [ethanol] (9CI) notification requirements. The provisions (PMN P-95–1235; CAS No. 94213–53–3) is of § 721.185 apply to this section. subject to reporting under this section for the significant new uses described [60 FR 45083, Aug. 30, 1995] in paragraph (a)(2) of this section. § 721.5283 Cobaltate (5-), bis[4-[[6-[(4- (2) The significant new uses are: amino-6-chloro-1,3,5-triazin-2- (i) Industrial, commercial, and con- yl)amio]-1-hydroxy-3-sulfo-2- sumer activities. Requirements as speci- naphthalenyl]azo]-3-hydroxy-7- fied in § 721.80 (f), (v)(1), (w)(1), and nitro-1-naphthalenesulfonato(4-)]-, (x)(1). pentasodium. (ii) [Reserved] (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified as this section except as modified by this cobaltate (5-), bis[4-[[6-[(4-amino-6- paragraph. chloro-1,3,5-triazin-2-yl)amio]-1-hy- (1) Recordkeeping. Recordkeeping re- droxy-3-sulfo-2-naphthalenyl]azo]-3-hy- quirements specified in § 721.125 (a), (b), droxy-7-nitro-1- (c), and (i) are applicable to manufac- naphthalenesulfonato(4-)]-, turers, importers, and processors of pentasodium (PMN P-99–0990; CAS No. this substance. 91144–26–2) is subject to reporting under (2) Limitations or revocation of certain this section for the significant new use notification requirements. The provisions described in paragraph (a)(2) of this of § 721.185 apply to this section. section. (2) The significant new uses are: [63 FR 3430, Jan. 22, 1998] (i) Protection in the workplace. Re- quirements as specified in § 721.63 (a)(4), § 721.5282 Trisodium chloro (a)(5)(ii), (a)(5)(xii), and (a)(5)(xiii). [(trisubstituted heteromonocycle amino) propylamino]triazinylamino (ii) Industrial, commercial, and con- hydroxyazo sumer activities. Requirements as speci- naphthalenetrisulfonate. fied in § 721.80(j) (a spray applied automotive coating). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as a trisodium paragraph. chloro[(trisubstituted heteromonocycleamino) (1) Recordkeeping. Recordkeeping re- propylamino]triazinyl quirements as specified in § 721.125 (a), aminohydroxyazo (b), (c), (d), and (i) are applicable to naphthalenetrisulfonate (PMN P-94– manufacturers, importers, and proc- 2177) is subject to reporting under this essors of this substance. section for the significant new uses de- (2) Limitations or revocation of certain scribed in paragraph (a)(2) of this sec- notification requirements. The provisions tion. of § 721.185 apply to this section. (2) The significant new uses are: [68 FR 15085, Mar. 28, 2003]

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§ 721.5284 Chromate (5-), bis[4-hy- facturers, importers, and processors of droxy-7-[(2-hydroxy-1- this substance. naphthalenyl)azo]- 3-[(2-hydroxy-3- (2) Limitations or revocation of certain nitro-5-sulfophenyl)azo]-2- notification requirements. The provisions naphthalenesulfonato(4-)]-, pentasodium. of § 721.185 apply to this section. (a) Chemical substance and significant [58 FR 51685, Oct. 4, 1993] new uses subject to reporting. (1) The chemical substance identified as a § 721.5286 Benzenediazonium, [[[[(sub- Chromate (5-), bis[4-hydroxy-7-[(2-hy- stituted) droxy-1- naphthalenyl)azo]- 3-[(2-hy- azo]phenyl]sulfonyl]amino]-, cou- droxy-3-nitro-5-sulfophenyl)azo]-2- pled with aminophenol, diazotized aminobenzoic acid, diazotized (sub- naphthalenesulfonato(4-)]-, stituted) benzenesulfonic acid and pentasodium (PMN P-99–0114; CAS No. naphthalenol (generic). 159574–72–8) is subject to reporting under this section for the significant (a) Chemical substance and significant new use described in paragraph (a)(2) of new uses subject to reporting. (1) The this section. chemical substance identified generi- (2) The significant new uses are: cally as benzenediazonium, [[[[(sub- (i) Industrial, commercial, and con- stituted) sumer activities. Requirements as speci- azo]phenyl]sulfonyl]amino]-, coupled fied in § 721.80 (v)(1), (w)(1), and (x)(1). with aminophenol, diazotized amino- (ii) [Reserved] benzoic acid, diazotized (substituted) (b) Specific requirements. The provi- benzenesulfonic acid and naphthalenol sions of subpart A of this part apply to (PMN P-00–0045) is subject to reporting this section except as modified by this under this section for the significant paragraph. new use described in paragraph (a)(2) of (1) Recordkeeping. Recordkeeping re- this section. quirements as specified in § 721.125 (a), (2) The significant new uses are: (b), (c), and (i) are applicable to manufacturers, importers, and processors of (i) Industrial, commercial, and con- this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(f). notification requirements. The provisions (ii) [Reserved] of § 721.185 apply to this section. (b) Specific requirements. The provisions of subpart A of this part apply to [65 FR 81401, Dec. 26, 2000] this section except as modified by this § 721.5285 Ethoxylated substituted paragraph. naphthol. (1) Recordkeeping. Recordkeeping re- (a) Chemical substance and significant quirements as specified in § 721.125 (a), new uses subject to reporting. (1) The (b), (c), and (i) are applicable to manu- chemical substance identified generi- facturers, importers, and processors of cally as an ethoxylated substituted this substance. naphthol (PMN P-88–2484) is subject to (2) Limitations or revocation of certain reporting under this section for the sig- notification requirements. The provisions nificant new uses described in para- of § 721.185 apply to this section. graph (a)(2) of this section. (2) The significant new uses are: [68 FR 15086, Mar. 28, 2003] (i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and § 721.5288 Chromate(2-), [3-hydroxy-4- [(2-hydroxy-1-naphthenyl)azo]-7- (c)(4) (where N = 200 ppb). nitro-1-substituted][N-[7-hydroxy-8- (ii) [Reserved] [(2-hydroxy-5-nitrophenyl)azo]-1- (b) Specific requirements. The provi- substituted]-, salt (generic). sions of subpart A of this part apply to this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping. Recordkeeping re- chemical substance identified generi- quirements as specified in § 721.125 (a), cally as chromate(2-), [3-hydroxy-4-[(2- (b), (c), and (k) are applicable to manu- hydroxy-1-naphthenyl)azo]-7- nitro-1-

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substituted][N-[7-hydroxy-8-[(2-hy- § 721.5293 Poly(oxy-1,2-ethanediyl), droxy-5-nitrophenyl)azo]-1-sub- alpha-(9Z)-9-octadecenyl-.omega.-hy- stituted]-, salt (PMN P-99–783) is sub- droxy-, phosphate, ammonium salt. ject to reporting under this section for (a) Chemical substance and significant the significant new use described in new uses subject to reporting. (1) The paragraph (a)(1) of this section. chemical substance identified as (2) The significant new uses are: poly(oxy-1,2-ethanediyl), alpha-(9Z)-9- (i) Industrial, commercial, and con- octadecenyl-.omega.-hydroxy-, phos- sumer activities. Requirements as speci- phate, ammonium salt (PMN P-99–920; fied in § 721.80(f). CAS No. 58857–49–1) is subject to reporting under this section for the signifi- (ii) [Reserved] cant new use described in paragraph (b) Specific requirements. The provi- (a)(1) of this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Industrial, commercial, and con- paragraph. sumer activities. Requirements as speci- (1) Recordkeeping. Recordkeeping re- fied in § 721.80(f). quirements as specified in § 721.125(a), (ii) [Reserved] (b), (c), and (i) are applicable to manu- (b) Specific requirements. The provi- facturers, importers, and processors of sions of subpart A of this part apply to this chemical substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manu- [68 FR 70178, Dec. 17, 2003] facturers, importers, and processors of this chemical substance. § 721.5290 Phenylazoalkoxy (2) Limitations or revocation of certain naphthylamines (generic). notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The [68 FR 70178, Dec. 17, 2003] chemical substances identified generically as phenylazoalkoxy § 721.5310 Neononanoic acid, ethenyl napthylamines (PMNs P-97–42 and P-97– ester. 43) are subject to reporting under this (a) Chemical substance and significant section for the significant new uses de- new uses subject to reporting. (1) The scribed in paragraph (a)(2) of this sec- chemical substance identified as tion. neononanoic acid, ethenyl ester (PMN (2) The significant new uses are: P-92–129) is subject to reporting under (i) Release to water. Requirements as this section for the significant new uses described in paragraph (a)(2) of specified in § 721.90 (a)(4), (b)(4), and this section. The requirements of this (c)(4) (N = 50 for P-97–42) (N = 40 for P- section do not apply once the sub- 97–43). stance has been incorporated into a (ii) [Reserved] polymer matrix with the level of resid- (b) Specific requirements. The provi- ual monomer below 0.1 percent. sions of subpart A of this part apply to (2) The significant new uses are: (i) this section except as modified by this Protection in the workplace. Require- paragraph. ments as specified in § 721.63 (a)(1), (1) Recordkeeping. Recordkeeping re- (a)(2)(i) (There must be no permeation quirements as specified in § 721.125 (a), of the substance greater than 0.02 μg/ (b), (c), and (k) are applicable to manu- min · cm2 after 8 hours of testing in ac- facturers, importers, and processors of cordance with the most current version these substances. of the American Society for Testing (2) Limitations or revocation of certain and Materials (ASTM) F739 ‘‘Standard notification requirements. The provisions Test Method for Resistance of Protec- of § 721.185 apply to this section. tive Clothing Materials to Permeation by Liquids or Gases.’’ For conditions of [63 FR 44578, Aug. 20, 1998] exposure which are intermittent,

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gloves may be tested in accordance (a)(5)(xiii) (if data on cartridge service with the most current version of ASTM life testing has been reviewed and ap- F1383 ‘‘Standard Test Method for Re- proved in writing by EPA), (a)(6)(i), sistance of Protective Clothing Mate- (a)(6)(ii), (a)(6)(iv), and (a)(6)(v). As an rials to Permeation by Liquids or alternative to the respiratory require- Gases Under Conditions of Intermit- ments in this section, manufacturers, tent Contact,’’ provided the contact importers, and processors may use the time in testing is greater than or equal New Chemical Exposure Limits provi- to the expected duration of dermal con- sions, including sampling and analyt- tact, and the purge time used in test- ical methods which have previously ing is less than or equal to the ex- been approved by EPA for this sub- pected duration of noncontact during stance, found in the 5(e) consent order the intermittent cycle of dermal expo- for this substance. sure in the workplace. If ASTM F1383 is (ii) Hazard communication program. used for testing, manufacturers, im- Requirements as specified in § 721.72 (a), porters, and processors must submit to (b), (c), (d), (e) (concentration set at 0.1 the Agency a description of worker ac- percent), (f), (h)(1)(vi) (The following tivities involving the substance which additional statements shall appear on includes daily frequencies and dura- each label required by this paragraph: tions of potential worker exposures. The health effects of this material The results of all glove permeation have not been fully determined but are testing must be reported in accordance currently being tested. EPA is con- with the most current version of ASTM cerned however, that this material F1194 ‘‘Guide for Documenting the Re- may have serious chronic health and sults of Chemical Permeation Testing environmental effects. When using this of Protective Clothing Materials.’’ material, use eye and skin protection, Manufacturers, importers, and proc- which includes gloves which have been essors must submit all test data to the determined to be impervious to this Agency and must receive written Agen- substance. Use respiratory protection, cy approval for each type of glove test- unless workplace airborne concentra- ed prior to use of such gloves. The fol- tions are maintained at or below an 8– lowing gloves have been tested in ac- h time weighted average (TWA) of 1 cordance with the ASTM F739 method ppm, when there is a likelihood of ex- and found by EPA to satisfy the re- posure in the work area from dust, quirements for continuous use: North/ mist, smoke or vapors.), (h)(2)(ii)(F), F101/Vitron gloves, 0.03 cm thick; and (h)(2)(ii)(G), (h)(2)(ii)(I), (h)(2)(iii)(A), Ansell/Edmont/4H/PE/EVOH/PE Lami- (h)(2)(iii)(B), (h)(2)(iii)(C), (h)(2)(iii)(E), nate gloves, 0.006 cm thick. Gloves may (h)(2)(iv)(A), (h)(2)(iv)(B) (The following not be used for a time period longer additional statements shall appear on than they are actually tested and must each MSDS required by this paragraph: be replaced at the end of each work This substance may cause moderate shift.), (a)(2)(ii) (With the exception of skin irritation. This substance may laboratory activities, full body chem- cause neurotoxicity. When using this ical protective clothing is required for substance, use respiratory protection, any worker activity in which the sub- unless workplace airborne concentra- stance is reasonably likely to contact tions are maintained at or below an 8- the worker in the following state(s): h TWA of 1 ppm.) Open liquid pool or solid of greater (iii) Industrial, commercial, and con- than 5 kg; liquid spray or splash; mist; sumer activities. Requirements as speci- aerosol dust; or any worker activity fied in § 721.80(q). which have potential for contact with (iv) Release to water. Requirements as the substance for more than 10 min/h. specified in § 721.90 (a)(4), (b)(4), and At a minimum, a chemical protective (c)(4) (where N = 5 ppb). When calcu- apron is required for any worker activ- lating the surface water concentrations ity with potential for contact with the according to the instructions in substance which is not covered by this § 721.91(a)(4), the statement that the paragraph), (a)(2)(iii), (a)(3), (a)(4), amount of the substance that will be (a)(5)(iii) (if cartridge service life test- released will be calculated before the ing is not available), (a)(5)(xii) or substance enters control technology

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does not apply. Instead, if the waste (i) Industrial, commercial, and con- stream containing the substance will sumer activities. Requirements as speci- be treated before release, then the fied in § 721.80(f) and (j). amount of the substance reasonably (ii) [Reserved] likely to be removed from the waste (b) Specific requirements. The provi- stream by such treatment may be sub- sions of subpart A of this part apply to tracted in calculating the number of this section except as modified by this kilograms released. No more than 75 paragraph. percent removal efficiency may be at- (1) Recordkeeping. Recordkeeping re- tributed to such treatment. In addi- quirements as specified in § 721.125(a), tion, when the substance is released in (b), (c), and (i) are applicable to manu- combination with the substances facturers, importers, and processors of hexanedioic acid, diethenyl ester, this chemical substance. hexanoic acid, 2-ethyl-, ethenyl ester, (2) Limitations or revocation of certain and propanoic acid, 2,2-dimethyl-, eth- notification requirements. The provisions enyl ester, the quotient from the for- of § 721.185 apply to this section mula referenced in this section shall (3) Determining whether a specific use is not exceed the average of the quotient subject to this section. The provisions of applicable to the other substances § 721.1725(b)(1) apply to this section. weighted by the proportion of each substance present in the total daily [68 FR 70178, Dec. 17, 2003] amount released. (b) Specific requirements. The provi- § 721.5325 Nickel acrylate complex. sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance nickel acrylate (1) Recordkeeping. Recordkeeping re- complex (PMN P-85–1034) is subject to quirements as specified in § 721.125 (a) reporting under this section for the sig- through (i), and (k) are applicable to nificant new uses described in para- manufacturers, importers, and proc- graph (a)(2) of this section. essors of this substance. Manufactur- (2) The significant new uses are: ers, importers, and processors of the (i) Protection in the workplace. Re- substance must keep records docu- quirements as specified in § 721.63 (a)(1), menting that the PMN substance has (a)(3), (b) (concentration set at 0.1 per- been incorporated into a polymer ma- cent), and (c). trix with the level of residual monomer (ii) Hazard communication program. below 0.1 percent if this section does Requirements as specified in § 721.72 not apply as described in paragraph (b)(2), (c), (d), (e) (concentration set at (a)(1) of this section. 0.1 percent), (f), (g)(1)(iv), (g)(1)(vii), (2) Limitations or revocation of certain (g)(2)(i) through (g)(2)(iii), (g)(2)(v), notification requirements. The provisions (g)(4)(i), and (g)(5). The provision of of § 721.185 apply to this section. § 721.72(d) requiring that employees to (3) Determining whether a specific use is be provided with information on the lo- subject to this section. The provisions of cation and availability of a written § 721.1725(b)(1) apply to this section. hazard communication program does [58 FR 51705, Oct. 4, 1993, as amended at 58 FR not apply when the written program is 68311, Dec. 27, 1993] not required under § 721.72(a). (iii) Industrial, commercial, and con- § 721.5315 Nickel, cobalt mixed metal sumer activities. Requirements as speci- oxide (generic). fied in § 721.80(k). (a) Chemical substance and significant (iv) Disposal. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), chemical substance identified generi- (c)(1), and (c)(2). cally as nickel, cobalt mixed metal (b) Specific requirements. The provi- oxide. (PMN P-02–90) is subject to re- sions of subpart A of this part apply to porting under this section for the sig- this section except as modified by this nificant new use described in paragraph paragraph. (a)(2) of this section. (1) Recordkeeping. The following rec- (2) The significant new uses are: ordkeeping requirements are applicable

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to manufacturers, importers, and proc- (b) Specific requirements. The provi- essors of this substance, as specified in sions of subpart A of this part apply to § 721.125 (a), (b), (c), (e), (f), (g), and (h). this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this significant new quirements as specified in § 721.125 (a) use rule. through (k) are applicable to manufac- (3) Determining whether a specific use is turers, importers, and processors of subject to this section. The provisions of this substance. § 721.1725(b)(1) apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [55 FR 39901, Sept. 28, 1990. Redesignated and of § 721.185 apply to this section. amended at 58 FR 29946, 29947, May 24, 1993; 58 FR 34204, June 23, 1993] [58 FR 51685, Oct. 4, 1993]

§ 721.5330 Nickel salt of an organo § 721.5340 Substituted benzothiazole- compound containing nitrogen. azo-substituted benzoquinoline (a) Chemical substance and significant nickel complex (generic). new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance generically identi- new uses subject to reporting. (1) The fied as nickel salt of an organo com- chemical substance identified generi- pound containing nitrogen (PMN P-92– cally as substituted benzothiazole-azo- 686) is subject to reporting under this substituted benzoquinoline nickel com- section for the significant new uses de- plex (PMN P-99–897) is subject to re- scribed in paragraph (a)(2) of this sec- porting under this section for the sig- tion. nificant new use described in paragraph (2) The significant new uses are: (a)(1) of this section. (i) Protection in the workplace. Re- (2) The significant new uses are: quirements as specified in § 721.63 (a)(1), (i) Release to water. Requirements as (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), specified in § 721.90(a)(1), (b)(1), and (a)(5)(iii), (a)(6)(i), (b) (concentration (c)(1). set at 0.1 percent), and (c). (ii) [Reserved] (ii) Hazard communication program. (b) Specific requirements. The provi- Requirements as specified in § 721.72 (a), sions of subpart A of this part apply to (b), (c), (d), (f), (g)(1)(ii), (g)(1)(vii), this section except as modified by this (g)(1)(viii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), paragraph. (g)(3)(ii), (g)(4)(i), and (g)(5). The fol- (1) Recordkeeping. Recordkeeping re- lowing additional statements shall ap- quirements as specified in § 721.125(a), pear on each label and MSDS as re- (b), (c), and (k) are applicable to manu- quired by this paragraph: This sub- facturers, importers, and processors of stance may cause skin sensitization. this chemical substance. This substance may cause blood ef- (2) Limitations or revocation of certain fects. notification requirements. The provisions (iii) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as speci- [68 FR 70178, Dec. 17, 2003] fied in § 721.80 (b), (c), and (k). (iv) Disposal. Requirements as speci- § 721.5350 Substituted nitrile (generic fied in § 721.85(a)(2) (landfill operated in name). accordance with subtitle C of the Re- (a) Chemical substances and significant source Conservation and Recovery Act new uses subject to reporting. (1) The (RCRA) to receive nickel wastes), chemical substance identified generi- § 721.85(b)(2) (landfill operated in ac- cally as a substituted nitrile (PMN P- cordance with subtitle C of RCRA to 83–603) is subject to reporting under receive nickel wastes), and § 721.85(c)(2) this section for the significant new (landfill operated in accordance with uses described in paragraph (a)(2) of subtitle C of RCRA to receive nickel this section. wastes). (2) The significant new uses are: (v) Release to water. Requirements as (i) Protection in the workplace. Re- specified in § 721.90 (a)(4), (b)(4), and quirements as specified in § 721.63 (a)(1), (c)(4) (where N = 40 ppb). (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)

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(iii), (a)(6)(v), (b) (concentration set at (2) The significant new uses are: 1 percent), and (c). (i) Industrial, commercial, and con- (ii) Hazard communication program. sumer activities. Requirements as speci- Requirements as specified in § 721.72 (a), fied in § 721.80 (f) and (j) (pesticide (b)(1), (d), (e) (concentration set at 1 inert). percent), (f), (g)(1)(iii), (g)(1)(vii), (ii) [Reserved] (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (b) Specific requirements. The provi- (g)(2)(v), (g)(3)(ii), and (g)(4)(i). The pro- sions of subpart A of this part apply to vision of § 721.72(d) requiring that em- this section except as modified by this ployees be provided with information paragraph. on the location and availability of (1) Recordkeeping. The recordkeeping MSDSs does not apply when an MSDS requirements specified in § 721.125 (a), was not required under § 721.72(c). The (b), (c), and (i) are applicable to manu- provision of § 721.72(g) requiring place- facturers, importers, and processors of ment of specific information on an this substance. MSDS does not apply when an MSDS is (2) Limitations or revocation of certain not required under § 721.72(c). notification requirements. The provisions (iii) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as specified in § 721.80(k). [63 FR 44579, Aug. 20, 1998] (iv) Release to water. Requirements as § 721.5358 2-propanol, 1,1′,1′-nitrilotris- specified in § 721.90 (a)(4), (b)(4), and , compds. with ethanol 2-[2-(C12-14- (c)(4) (level set at 1 ppb). alkyloxy) ethoxy] derivs. hydrogen (b) Specific requirements. The provi- sulfates. sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified as 2-pro- (1) Recordkeeping. The following rec- panol, 1,1′,1′-nitrilotris-, compds. with ordkeeping requirements are applicable ethanol 2-[2-(C12–14- alkyloxy) ethoxy] to manufacturers, importers, and proc- derivs. hydrogen sulfates (PMN P-99– essors of this substance, as specified in 928; CAS No. 222975–06–6) is subject to § 721.125 (a) through (g), (i), and (k). reporting under this section for the sig- (2) Limitations or revocation of certain nificant new use described in paragraph notification requirements. The provisions (a)(2) of this section. of § 721.185 apply to this section. (2) The significant new uses are: (3) Determining whether a specific use is (i) Industrial, commercial, and con- subject to this section. The provisions of sumer activities. Requirements as speci- § 721.1725(b)(1) apply to this section. fied in § 721.80(j) (surfactant used in toi- [55 FR 33305, Aug. 15, 1990; 55 FR 52275, Dec. let bowl cleaner). 21, 1990. Redesignated and amended at 58 FR (ii) [Reserved] 29946, 29947, May 24, 1993; 58 FR 34204, June 23, (b) Specific requirements. The provi- 1993] sions of subpart A of this part apply to this section except as modified by this ′ ″ § 721.5356 Ethanol, 2,2 2 -nitrilotris-, paragraph. compound with alpha-2,4,6-tris (1- phenylethyl)phenyl]-omega- (1) Recordkeeping. Recordkeeping re- hydroxypoly (oxy-1,2-ethanediyl) quirements as specified in § 721.125(a), phosphate. (b), (c), and (i) are applicable to manufacturers, importers, and processors of (a) Chemical substance and significant this chemical substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified as eth- notification requirements. The provisions anol, 2,2′2″-nitrilotris-, compound with of 721.185 apply to this section. alpha-[2,4,6-tris(1-phenylethyl)phenyl]- omega-hydroxypoly (oxy-1,2- [68 FR 70178, Dec. 17, 2003] ethanediyl) phosphate (PMN P-98–185) is subject to reporting under this sec- § 721.5360 Substituted nitrobenezene tion for the significant new uses de- (generic). scribed in paragraph (a)(2) of this sec- (a) Chemical substance and significant tion. new uses subject to reporting. (1) The

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chemical substance identified generi- (2) Limitations or revocation of certain cally as substituted nitrobenezene notification requirements. The provisions (PMN P-97–1028) is subject to reporting of § 721.185 apply to this significant new under this section for the significant use rule. new uses described in paragraph (a)(2) (3) Determining whether a specific use is of this section. subject to this section. The provisions of (2) The significant new uses are: § 721.1725(b)(1) apply to this section. (i) Protection in the workplace. Re- [55 FR 26110, June 26, 1990. Redesignated and quirements as specified in § 721.63 amended at 58 FR 29946, 29947, May 24, 1993; 58 (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii), FR 34204, June 23, 1993] (a)(5)(iv), (a)(5)(v), and (a)(6)(v). (ii) Industrial, commercial, and con- § 721.5378 9- sumer activities. Requirements as speci- Phosphabicyclo[3.3.1]nonane,9,9′- fied in § 721.80(g). (1,2-ethanediyl)bis- (9C1). (iii) Release to water. Requirements as (a) Chemical substance and significant specified in § 721.90 (a)(1), (b)(1), and new uses subject to reporting. (1) The (c)(1). chemical substance identified as 9- (b) Specific requirements. The provi- Phosphabicyclo[3.3.1]nonane,9,9′-(1,2- sions of subpart A of this part apply to ethanediyl)bis- (9C1) (PMN P-99–0754; this section except as modified by this CAS No.153280–11–6) is subject to re- paragraph. porting under this section for the sig- (1) Recordkeeping. The recordkeeping nificant new use described in paragraph requirements specified in § 721.125 (a), (a)(2) of this section. (b), (c), (d), (e), (i), and (k) are applica- (2) The significant new uses are: ble to manufacturers, importers, and (i) Industrial, commercial, and con- processors of this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80 (f), (v)(2), (w)(2), and notification requirements. The provisions (y)(2). of § 721.185 apply to this section. (ii) Release to water. Requirements as specified § 721.90 (a)(1), (b)(1), and (c)(1). [63 FR 44579, Aug. 20, 1998] (b) Specific requirements. The provi- § 721.5375 Nitrothiophenecarboxylic sions of subpart A of this part apply to acid, ethyl ester, this section except as modified by this bis[[[[(substituted)] amino]alkyl- paragraph. phenyl]azo] (generic name). (1) Recordkeeping. Recordkeeping re- (a) Chemical substance and significant quirements as specified in § 721.125 (a), new uses subject to reporting. (1) The (b), (c), (i), and (k) are applicable to chemical substance nitrothiophenecar- manufacturers, importers, and proc- boxylic acid, ethyl ester, bis [[[[(sub- essors of this substance. stituted)]amino]alkylphenyl]azo] (PMN (2) Limitations or revocation of certain P-87–304) is subject to reporting under notification requirements. The provisions this section for the significant new of § 721.185 apply to this section. uses described in paragraph (a)(2) of [65 FR 81401, Dec. 26, 2000] this section. (2) The significant new uses are: § 721.5380 Mixed alkyl phenolic (i) Industrial, commercial, and con- novolak resin (generic). sumer activities. Requirements as speci- (a) Chemical substance and significant fied in § 721.80 (f), (k), (v)(1), (w)(1), and new uses subject to reporting. (1) The (x)(1). chemical substance identified generi- (ii) [Reserved] cally as mixed alkyl phenolic novolak (b) Specific requirements. The provi- resin (PMN P-98–718) is subject to re- sions of subpart A of this part apply to porting under this section for the sig- this section except as modified by this nificant new use described in paragraph paragraph. (a)(2) of this section. (1) Recordkeeping. The following rec- (2) The significant new uses are: ordkeeping requirements are applicable (i) Release to water. Requirements as to manufacturers, importers, and proc- specified in § 721.90 (a)(1), (b)(1), and essors of this substance, as specified in (c)(1). § 721.125 (a), (b), and (c). (ii) [Reserved]

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(b) Specific requirements. The provi- § 721.5400 3,6,9,12,15,18,21-Heptaoxa- sions of subpart A of this part apply to tetratriaoctanoic acid, sodium salt. this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping. Recordkeeping re- chemical substance identified as quirements as specified in § 721.125 (a), 3,6,9,12,15,18,21-heptaoxatetratriaocta- (b), (c), and (k) are applicable to manu- noic acid, sodium salt is subject to re- facturers, importers, and processors of porting under this section for the sig- this substance. nificant new uses described in para- (2) Limitations or revocation of certain graph (a)(2) of this section. notification requirements. The provisions (2) The significant new use is: of § 721.185 apply to this section. (i) Release to water. Requirements as [65 FR 372, Jan. 5, 2000] specified in § 721.90 (a)(1), (b)(1), and (c)(1). § 721.5385 Octanoic acid, hydrazide. (ii) [Reserved] (b) The provi- (a) Chemical substance and significant Specific requirements. sions of subpart A of this part apply to new uses subject to reporting. (1) The chemical substance identified as this section except as modified by this octanoic acid, hydrazide (PMN P-92– paragraph. 1086) is subject to reporting under this (1) Recordkeeping. The following rec- section for the significant new uses de- ordkeeping requirements are applicable scribed in paragraph (a)(2) of this sec- to manufacturers, importers, and proc- tion. essors of this substance, as specified in § 721.125 (a), (b), (c), and (k). (2) The significant new uses are: (i) (2) Limitations or revocation of certain Protection in the workplace. Require- notification requirements. The provisions ments as specified in § 721.63 (a)(1), of § 721.185 apply to this significant new (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), use rule. (a)(5)(vi), (a)(5)(vii), (a)(6)(ii), (b) (concentration set at 0.1 percent), and (c). [56 FR 19237, Apr. 25, 1991. Redesignated at 58 (ii) Hazard communication program. FR 29946, May 24, 1993, as amended at 58 FR Requirements as specified in § 721.72 (a), 34204, June 23, 1993] (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(i), (g)(1)(ii), § 721.5425 ù-Olefin sulfonate, potassium salts. (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(i), (a) Chemical substance and significant and (g)(5). new uses subject to reporting. (1) The (iii) Industrial, commercial, and con- chemical substance identified as an a- sumer activities. Requirements as speci- olefin sulfonate, potassium salt (PMN fied in § 721.80(q). P-91–100) is subject to reporting under (iv) Disposal. Requirements as speci- this section for the significant new fied in § 721.85 (a)(1) and (b)(1). uses described in paragraph (a)(2) of (b) Specific requirements. The provi- this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Release to water. Requirements as paragraph. specified in § 721.90 (a)(1), (b)(1), and (c)(1). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a) (ii) [Reserved] through (j) are applicable to manufac- (b) Specific requirements. The provi- turers, importers, and processors of sions of subpart A of this part apply to this substance. this section except as modified by this paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. The following rec- notification requirements. The provisions ordkeeping requirements are applicable of § 721.185 apply to this section. to manufacturers, importers, and proc- (3) Determining whether a specific use is essors of this substance, as specified in subject to this section. The provisions of § 721.125 (a), (b), (c), and (k). § 721.1725(b)(1) apply to this section. (2) Limitations or revocation of certain [58 FR 51706, Oct. 4, 1993] notification requirements. The provisions

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of § 721.185 apply to this significant new turers, importers, and processors of use rule. this substance (2) Limitations or revocation of certain [56 FR 40215, Aug. 13, 1991. Redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR notification requirements. The provisions 34204, June 23, 1993] of § 721.185 apply to this section. (3) Determining whether a specific use is § 721.5450 ù-Olefin sulfonate, sodium subject to this section. The provisions of salt. § 721.1725(b)(1) apply to this section. (a) Chemical substance and significant [57 FR 44068, Sept. 23, 1992, as amended at 58 new uses subject to reporting. (1) The FR 29946, May 24, 1993; 58 FR 34204, June 23, chemical substance identified generi- 1993] cally as a-olefin sulfonate, sodium salt (PMN P-88–2210) is subject to reporting § 721.5452 Alkali metal salt of halo- under this section for the significant genated organoborate (generic). new uses described in paragraph (a)(2) (a) Chemical substance and significant of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substances identified generi- (i) Hazard communication program. A cally as alkali metal salt of halo- significant new use of this substance is genated organoborate (PMN P-00–0638) any manner or method of manufacture, is subject to reporting under this sec- import, or processing associated with tion for the significant new use de- any use of this substance without pro- scribed in paragraph (a)(2) of this sec- viding risk notification as follows: tion. (A) If as a result of the test data re- (2) The significant new uses are: quired under the section 5(e) consent (i) Release to water. Requirements as order for this substance, the employer specified in § 721.90 (a)(1), (b)(1), and becomes aware that this substance (c)(1). may present a risk of injury to human (ii) [Reserved] health, the employer must incorporate (b) Specific requirements. The provi- this new information, and any informa- sions of subpart A of this part apply to tion on methods for protecting against this section except as modified by this such risk, into an MSDS as described paragraph. in § 721.72(c) within 90 days from the (1) Recordkeeping. Recordkeeping re- time the employer becomes aware of quirements as specified in § 721.125 (a), the new information. If this substance (b), (c), and (k) are applicable to manu- is not being manufactured, imported, facturers, importers, and processors of processed, or used in the employer’s this substance. workplace, the employer must add the (2) Limitations or revocation of certain new information to an MSDS before notification requirements. The provisions the substance is reintroduced into the of § 721.185 apply to this section. workplace. [68 FR 15086, Mar. 28, 2003] (B) The employer must ensure that persons who will receive this substance § 721.5454 Methylium, tripohenyl-, from the employer are provided an tetrakis(pentafluorophenyl) borate MSDS as described in § 721.72(c) con- (1-). taining the information required under (a) Chemical substance and significant paragraph (a)(1)(i)(A) within 90 days new uses subject to reporting. (1) The from the time the employer becomes chemical substances identified as aware of the new information. methylium, tripohenyl-, (ii) Industrial, commercial, and con- tetrakis(pentafluorophenyl) borate (1-) sumer activities. Requirements as speci- (PMN P-00–0637; CAS No. 136040–19–2) is fied in § 721.80(q). subject to reporting under this section (b) Specific requirements. The provi- for the significant new use described in sions of subpart A of this part apply to paragraph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Release to water. Requirements as (1) Recordkeeping requirements. Re- specified in § 721.90 (a)(1), (b)(1), and quirements as specified in § 721.125 (a), (c)(1). (h), and (i) are applicable to manufac- (ii) [Reserved]

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(b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. these substances. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [68 FR 15086, Mar. 28, 2003] [65 FR 372, Jan. 5, 2000] § 721.5460 Organosolv lignin. § 721.5475 1-Oxa-4-azaspiro[4.5]decane, (a) Chemical substance and significant 4-dichloroacetyl-. new uses subject to reporting. (1) The chemical substance identified as an (a) Chemical substance and significant organosolv lignin (PMN P-95–1584; CAS new uses subject to reporting. (1) The No. 8068–03–9) is subject to reporting chemical substance identified as 1-oxa- under this section for the significant 4-azaspiro[4.5]decane, 4-dichloroacetyl- new use described in paragraph (a)(2) of (PMN P-86–1648, CAS number 71526-07-3) this section. is subject to reporting under this sec- (2) The significant new use is any tion for the significant new uses de- manufacture, processing, or use of the scribed in paragraph (a)(2) of this sec- substance with a number average motion. lecular weight less than 700 daltons. (2) The significant new uses are: (b) Specific requirements. The provi- (i) Protection in the workplace. Re- sions of subpart A of this part apply to quirements as specified in § 721.63 this section except as modified by this (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3) (ap- paragraph. plies to gloves only), (a)(4), (a)(5)(i), (1) Recordkeeping. Recordkeeping re- (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), (a)(6)(i), quirements as specified in § 721.125 (a), (b) (concentration set at 1.0 percent), (b), (c), and records documenting com- and (c). pliance with the designated molecular (ii) Hazard communication program. weight requirements are applicable to Requirements as specified in § 721.72 (a), manufacturers, importers, and proc- (b)(2), (c), (d), (e) (concentration set at essors of this substance. 1.0 percent), (f), (g)(1)(ix), (g)(2)(i), (2) Limitations or revocation of certain notification requirements. The provisions (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), of § 721.185 apply to this section. and (g)(5). (iii) Industrial, commercial, and con- [63 FR 65710, Nov. 30, 1998] sumer activities. Requirements as specified in § 721.80 (f) and (k). § 721.5465 Amine salt of organic acid (generic). (iv) Disposal. Requirements as specified in § 721.85 (a)(1), (b)(1) and (c)(1). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The chemical substance identified generi- sions of subpart A of this part apply to cally as amine salt of organic acid this section except as modified by this (PMN P-98–1172) is subject to reporting paragraph. under this section for the significant (1) Recordkeeping requirements. Re- new uses described in paragraph (a)(2) quirements as specified in § 721.125 (a) of this section. through (j) are applicable to manufac- (2) The significant new uses are: turers, importers, and processors of (i) Release to water. Requirements as this substance. specified in § 721.90 (a)(1), (b)(1), and (2) Limitations or revocation of certain (c)(1). notification requirements. The provisions (ii) [Reserved] of § 721.185 apply to this section.

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(3) Determining whether a specific use is § 721.5525 Substituted spiro oxazine. subject to this section. The provisions of (a) Chemical substance and significant § 721.1725(b)(1) apply to this section. new uses subject to reporting. (1) The [57 FR 44068, Sept. 23, 1992, as amended at 58 chemical substance identified generi- FR 29946, May 24, 1993; 58 FR 34204, June 23, cally as substituted spiro oxazine 1993] (PMN P-92–283) is subject to reporting under this section for the significant § 721.5500 7-Oxabicyclo[4.1.0]heptane, 3-ethenyl, homopolymer, ether with new uses described in paragraph (a)(2) 2-ethyl-2-(hydroxymethyl)-1,3-proof this section. panediol (3:1), epoxidized. (2) The significant new uses are: (a) Chemical substance and significant (i) Release to water. Requirements as new uses subject to reporting. (1) The specified in § 721.90 (a)(1), (b)(1), and chemical substance 7-oxabicyclo[4.1.0] (c)(1). heptane, 3-ethenyl, homopolymer, (ii) [Reserved] ether with 2-ethyl-2(hydroxymethyl)- (b) Specific requirements. The provi- 1,3-propanediol (3:1), epoxidized (PMN sions of subpart A of this part apply to P-88–1898) is subject to reporting under this section except as modified by this this section for the significant new paragraph. uses described in paragraph (a)(2) of (1) Recordkeeping requirements. Rec- this section. ordkeeping requirements as specified (2) The significant new uses are: at § 721.125 (a), (b), (c), and (k) are appli- (i) Protection in the workplace. Re- cable to manufacturers, importers, and quirements as specified in § 721.63 (a)(1), processors of this substance. (a)(3), (a)(4), (a)(5)(ii), (a)(5)(viii), (2) Limitations or revocation of certain (a)(5)(ix), (a)(6)(i), (a)(6)(ii), (b) (con- notification requirements. The provisions centration set at 0.1 percent), and (c). of § 721.185 apply to this section. (ii) Hazard communication program. Requirements as specified in § 721.72 (a), [57 FR 31969, July 20, 1992, as amended at 58 (b), (c), (d), (e) (concentration set at 0.1 FR 34204, June 23, 1993] percent), (f), (g)(1)(vi), (g)(1)(vii), § 721.5540 1H,3H,5H-oxazolo [3,4-c] (g)(2)(i) through (g)(2)(v), (g)(3)(i), oxazole, dihydro-7a-methyl-. (g)(3)(ii), (g)(4)(i), and (g)(5). (iii) Industrial, commercial, and con- (a) Chemical substances and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80 (l) and (q). chemical substance identified as (iv) Disposal. Requirements as speci- 1H,3H,5H-oxazolo [3,4-c] oxazole, fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), dihydro-7a-methyl- (PMN P-91–1324) is (c)(1), and (c)(2). subject to reporting under this section (b) Specific requirements. The provi- for the significant new uses described sions of subpart A of this part apply to in paragraph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Protection in the workplace. Re- (1) Recordkeeping. The following rec- quirements as specified in § 721.63 ordkeeping requirements are applicable (a)(2)(iii) and (a)(3). to manufacturers, importers, and proc- (ii) Release to water. Requirements as essors of this substance, as specified in specified in § 721.90 (a)(4), (b)(4), and § 721.125 (a) through (j). (c)(4) (where N = 500 ppb). (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this significant new this section except as modified by this use rule. paragraph. (3) Determining whether a specific use is (1) Recordkeeping requirements. The subject to this section. The provisions of following recordkeeping requirements § 721.1725(b)(1) apply to this section. specified in § 721.125 (a), (b), (c), (d), (e), [55 FR 39902, Sept. 28, 1990. Redesignated and and (k) are applicable to manufactur- amended at 58 FR 29946, 29947, May 24, 1993; 58 ers, importers, and processors of this FR 34204, June 23, 1993] substance.

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(2) Limitations or revocation of certain (i) Industrial, commercial, and con- notification requirements. The provisions sumer activities. Requirements as speci- of § 721.185 apply to this section. fied in § 721.80(q). [60 FR 26691, May 18, 1995] (ii) Hazard communication program. A significant new use of these chemical § 721.5545 3-(Dichloroacetyl)-5-(2- substances is any manner or method of furanyl)-2,2-dimethyl-oxazolidine. manufacture, import, or processing as- (a) Chemical substance and significant sociated with any use of these chemical new uses subject to reporting. (1) The substances without providing risk noti- chemical substance identified as 3- fication as follows: (dichloroacetyl)-5-(2-furanyl)-2,2- (A) If as a result of the test data re- dimethyloxazolidine (PMN P-93–1694) quired under the TSCA section 5(e) (CAS no. 121776–57–6) is subject to re- consent order for these chemical sub- porting under this section for the sig- stances, the employer becomes aware nificant new uses described in para- that these chemical substances may graph (a)(2) of this section. present a risk of injury to human (2) The significant new uses are: health or the environment, the em- (i) Protection in the workplace. Re- ployer must incorporate this new infor- quirements as specified in § 721.63 (a)(1), mation, and any information on meth- (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (b) (con- ods for protecting against such risk, centration set at 0.1%), and (c). into a Material Safety Data Sheet (ii) Hazard communication program. (MSDS) as described in § 721.72(c) with- Requirements as specified in § 721.72 (a), in 90 days from the time the employer (b), (c), (d), (e) (concentration set at becomes aware of the new information. 0.1%), (f), (g)(1)(iv), (g)(1)(vii), (g)(1)(ix), If this chemical substance is not being (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), manufactured, imported, processed, or (g)(3)(ii), and (g)(5). used in the employer’s workplace, the (iii) Industrial, commercial, and con- employer must add the new informa- sumer activites. Requirements as speci- tion to an MSDS before the chemical fied in § 721.80 (b), (c), (k) (as a seed substances are reintroduced into the safener), and (o). workplace. (b) Specific requirements. The provi- (B) The employer must ensure that sions of subpart A of this part apply to persons who will receive or who have this section except as modified by this received the chemical substances from paragraph. the employer within 5 years from the (1) Recordkeeping. Recordkeeping re- date the employer becomes aware of quirements as specified in § 721.125 (a), the new information described in para- (b), (c), (d), (e), (f), (g), (h), and (i) are graph (a)(2)(i)(A) of this section, are applicable to manufacturers, import- provided an MSDS as described in ers, and processors of this substance. § 721.72(c) containing the information (2) Limitations or revocation of certain required under paragraph (a)(2)(i)(A) of notification requirements. The provisions this section within 90 days from the of § 721.185 apply to this section. time the employer becomes aware of the new information. [61 FR 63739, Dec. 2, 1996] (b) Specific requirements. The provi- § 721.5546 Halogen substituted sions of subpart A of this part apply to oxetanes (generic). this section except as modified by this paragraph. (a) Chemical substance and significant new uses subject to reporting. (1) The (1) Recordkeeping. Recordkeeping re- chemical substances identified generi- quirements as specified in § 721.125 (a), cally as halogen substituted oxetanes. (b), (c), (f), (h), and (i) are applicable to (PMNs P-98–1033 through P-98–1035) are manufacturers, importers, and proc- subject to reporting under this section essors of these chemical substances. for the significant new uses described (2) Limitations or revocation of certain in paragraph (a)(2) of this section. notification requirements. The provisions (2) The significant new uses are: of § 721.185 apply to this section.

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(3) Determining whether a specific use is (2) The significant new uses are: subject to this section. The provisions of (i) Protection in the workplace. Re- § 721.1725(b)(1) apply to this section. quirements as specified in § 721.63 (a)(4), (a)(5)(iii), (a)(5)(iv), and (a)(6)(i). [68 FR 70178, Dec. 17, 2003] (ii) [Reserved] § 721.5547 Antimony double oxide. (b) Specific requirements. The provisions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substances identified generi- (1) Recordkeeping. The recordkeeping cally as antimony double oxide (PMNs requirements specified in § 721.125 (a), P-95–677 and P-95–724) are subject to re- (b), (c), and (d) are applicable to manu- porting under this section for the sig- facturers, importers, and processors of nificant new uses described in para- this substance. graph (a)(2) of this section. (2) Limitations or revocation of certain (2) The significant new uses are: notification requirements. The provisions (i) Hazard communication program. Re- of § 721.185 apply to this section. quirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 [63 FR 44579, Aug. 20, 1998] percent), (f), (g)(1)(vii), (g)(2)(ii), § 721.5549 Lithiated metal oxide. (g)(2)(iii), (g)(3)(ii), and (g)(5). The label and MSDS as required by this para- (a) Chemical substance and significant graph shall also include the following new uses subject to reporting. (1) The statements: These substances may chemical substance identified generi- cause lung toxicity. When using these cally as lithiated metal oxide (LiNiO2) substances avoid any applications of (PMN P-96–19; CAS No. 12031–65–1) is these substances which could cause in- subject to reporting under this section halation exposures. When using these for the significant new uses described substances keep in liquid form only. in paragraph (a)(2) of this section. (ii) Industrial, commercial, and con- (2) The significant new uses are: sumer activities. Requirements as speci- (i) Protection in the workplace. Re- fied in § 721.80 (f), (v)(1), (v)(2), (w)(1), quirements as specified in § 721.63 (a)(1), (w)(2), (x)(1), (x)(2), (y)(1), and (y)(2). (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(iv), Manufacturing, processing or use in (b) (concentration set at 0.1 percent), any form which could cause inhalation and (c). As an alternative to the res- exposures. piratory requirements listed here, a (b) Specific requirements. The provi- manufacturer, importer, or processor sions of subpart A of this part apply to may choose to follow the new chemical this section except as modified by this exposure limit (NCEL) provisions listed paragraph. in the TSCA section 5(e) consent order (1) Recordkeeping. Recordkeeping re- for this substance. quirements specified in § 721.125 (a), (b), (ii) Hazard communication program. (c), (f), (g), (h), and (i) are applicable to Requirements as specified in § 721.72 (a), manufacturers, importers, and proc- (b), (c), (d), (e) (concentration set at 0.1 essors of this substance. percent), (f) (g)(1)(iv), (g)(1)(vii), (2) Limitations or revocation of certain (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), notification requirements. The provisions (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), of § 721.185 apply to this section. (g)4)(i), and (g)(5). (iii) Industrial, commercial, and con- [63 FR 3431, Jan. 22, 1998] sumer activities. Requirements as specified in § 721.80(q). § 721.5548 Mixed metal oxide (generic). (iv) Release to water. Requirements as (a) Chemical substance and significant specified in § 721.90 (a)(4), (b)(4), and new uses subject to reporting. (1) The (c)(4) (N = 30). chemical substance identified generi- (b) Specific requirements. The provi- cally as a mixed metal oxide (PMN P- sions of subpart A of this part apply to 97–956) is subject to reporting under this section except as modified by this this section for the significant new paragraph. uses described in paragraph (a)(2) of (1) Recordkeeping. Recordkeeping re- this section. quirements as specified in § 721.125(a),

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(b), (c), (d), (e), (f), (g), (h), (i), and (k) § 721.5560 Formaldehyde, polymer are applicable to manufacturers, im- with (chloromethyl) oxirane and porters, and processors of this sub- phenol, reaction products with 6H- stance. dibenz[c,e][1,2]oxaphosphorin-6- (2) Limitations or revocation of certain oxide. notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1)The (3) Determining whether a specific use is chemical substance identified as form- subject to this section. The provisions of aldehyde, polymer with (chloromethyl) § 721.1725(b)(1) apply to this section. oxirane and phenol, reaction products with 6H-dibenz[c,e][1,2]oxaphosphorin- [63 FR 3431, Jan. 22, 1998] 6-oxide. (PMN P-00–991; CAS No. 300371– § 721.5550 Substituted dialkyl oxazo- 38–4) is subject to reporting under this lone (generic name). section for the significant new uses described in paragraph (a)(2) of this sec- (a) Chemical substances and significant tion. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified generically as substituted dialkyl oxazolone (i) Release to water. Requirements as (PMN P-86–1634) is subject to reporting specified in § 721.90(a)(4), (b)(4), and under this section for the significant (c)(4) (N=6). new uses described in paragraph (a)(2) (ii) [Reserved] of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 (a)(1), paragraph. (a)(3), (a)(4), (a)(5)(xi), (a)(6)(v), (b) (1) Recordkeeping. Recordkeeping re- (concentration set at 0.1 percent), and quirements as specified in § 721.125(a), (c). (b), (c), and (k) are applicable to manu- (ii) Hazard communication program. facturers, importers, and processors of Requirements as specified in § 721.72 (a), this chemical substance. (b)(2), (c), (d), (e) (concentration set at (2) Limitations or revocation of certain 0.1 percent), (f), (g)(1)(iii), (g)(1)(vi), notification requirements. The provisions (g)(1)(vii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), of § 721.185 apply to this section. (g)(2)(iv), and (g)(2)(v). [68 FR 70179, Dec. 17, 2003] (iii) Industrial, commercial, and consumer activities. Requirements as speci- § 721.5575 Oxirane, 2,2′-(1,6-hexanediyl- fied in § 721.80(q). bis (oxymethylene)) bis-. (iv) Disposal. Requirements as speci- (a) Chemical substance and significant fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), new uses subject to reporting. (1) The (c)(1), and (c)(2). chemical substance identified as (b) Specific requirements. The provi- oxirane, 2,2′-(1,6- sions of subpart A of this part apply to hexanediylbis(oxymethylene))bis- this section except as modified by this (PMNs P-88–2179 and P-89–539) is subparagraph. ject to reporting under this section for (1) Recordkeeping. The following rec- the significant new uses described in ordkeeping requirements are applicable paragraph (a)(2) of this section. to manufacturers, importers, and proc- (2) The significant new uses are: essors of this substance, as specified in (i) Protection in the workplace. Re- § 721.125 (a) through (j). quirements as specified in § 721.63 (2) Limitations or revocation of certain (a)(1),(a)(3), (a)(4), (a)(5)(viii), (a)(5)(ix), notification requirements. The provisions (a)(6)(ii), and (b) (concentration set at of § 721.185 apply to this section. 0.1 percent). (3) Determining whether a specific use is (ii) Hazard communication program. subject to this section. The provisions of Requirements as specified in § 721.72 (a), § 721.1725(b)(1) apply to this section. (b), (c), (d), (e) (concentration set at 0.1 [55 FR 33306, Aug. 15, 1990. Redesignated and percent), (f), (g)(1)(vi), (g)(1)(vii), amended at 58 FR 29946, 29947, May 24, 1993; 58 (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), FR 34204, June 23, 1993] (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).

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(iii) Industrial, commercial, and con- (ii) Hazard communication program. sumer activities. Requirements as speci- Requirements as specified in § 721.72 (a), fied in § 721.80 (l) and (q). (b), (c), (d), (e) (concentration set 0.1 (iv) Disposal. Requirements as speci- percent), (f), (g)(1)(vi), (g)(1)(vii), fied in § 721.85 (b)(1), (b)(2), (c)(1), and (g)(2)(ii), (g)(2)(iv), (g)(3)(i), (g)(3)(ii), (c)(2). (g)(4)(i), (g)(4)(iii), and (g)(5). (v) Release to water. Requirements as (iii) Industrial, commercial, and con- specified in § 721.90 (a)(2)(ii), (b)(1), and sumer activities. Requirements as speci- (c)(1). The following may be used as an fied in § 721.80 (f) and (q). alternative to the technologies in (iv) Release to water. Requirements as § 721.90(a)(2)(ii): Oil and grease separa- specified in § 721.90 (a)(1), (b)(1), and tion. (c)(1). (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. The following recordkeeping requirements are applicable (1) Recordkeeping. Recordkeeping re- to manufacturers, importers, and proc- quirements as specified in § 721.125 (a), essors of this substance: § 721.125 (a) (b), (c), (d), (f), (g), (h), (i), and (k) are through (k). applicable to manufacturers, import- (2) Limitation of revocation of certain ers, and processors of this substance. notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this significant new notification requirements. The provisions use rule. of § 721.185 apply to this section. (3) Determining whether a specific use is (3) Determining whether a specific use is subject to this section. The provisions of subject to this section. The provisions of § 721.1725(b)(1) apply to this section. § 721.1725(b)(1) apply to this section. [56 FR 19238, Apr. 25, 1991. Redesignated and [63 FR 44579, Aug. 20, 1998] amended at 58 FR 29946, 29947, May 24, 1993; 58 FR 34204, June 23, 1993] § 721.5585 4,4′-(1- methylethylidene)bisphenol, poly- § 721.5580 Oxirane, 2,2′- mer with (chloromethyl)oxirane [methylenebis[(2,6-dimethyl-4,1- and a diamine (generic). phenylene)oxymethylene]]bis-. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified as cally as 4,4′-(1- ′ oxirane, 2,2 -[methylenebis[(2,6-di- methylethylidene)bisphenol, polymer methyl-4,1-phen- with (chloromethyl) oxirane and a ylene)oxymethylene]]bis- (PMN P-97– diamine (PMN P-97–0916) is subject to 1011; CAS No. 93705–66–9) is subject to reporting under this section for the sig- reporting under this section for the significant new uses described in para- nificant new uses described in paragraph (a)(2) of this section. graph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Protection in the workplace. Re- (i) Hazard communication program. quirements as specified in § 721.63 (a)(4), Requirements as specified in § 721.72 (a), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (a)(5)(vii), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (g)(4)(iii), and (g)(5). (b) (concentration set at 0.1 percent), (ii) Release to water. Requirements as and (c). As an alternative to the res- specified in § 721.90 (a)(4), (b)(4), and piratory requirements listed here, a (c)(4) (N=2 ppb). manufacturer, importer, or processor (b) Specific requirements. The provi- may choose to follow the new chemical sions of subpart A of this part apply to exposure limit (NCEL) provisions listed this section except as modified by this in the TSCA section 5(e) consent order paragraph. for this substance. The NCEL is 0.35 (1) Recordkeeping. Recordkeeping re- milligram/meter3 (mg/m3). quirements as specified in § 721.125 (a),

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(b), (c), (f), (g), (h), (i), and (k) are ap- (f), (g)(1)(ii), (g)(1)(vii), (g)(2)(i), plicable to manufacturers, importers, (g)(2)(ii), (g)(2)(iv), and (g)(2)(v). The and processors of this substance. provisions of § 721.72(d) requiring em- (2) Limitations or revocation of certain ployees to be provided with informa- notification requirements. The provisions tion on the location and availability of of § 721.185 apply to this section. a written hazard communication pro- [65 FR 81401, Dec. 26, 2000] gram and MSDSs do not apply when the written program and MSDS are not § 721.5590 Oxirane, [[[(1R,2S,5R)-5- required under § 721.72 (a) and (c), re- methyl-2- (1- spectively. The provisions of § 721.72(g) methylethyl)cyclohexyl] requiring placement of specific infor- oxy]methyl]-. mation on a label and MSDS do not (a) Chemical substance and significant apply when a label and MSDS are not new uses subject to reporting. (1) The required under § 721.72 (b) and (c), re- chemical substance identified as spectively. oxirane, [[[(1R,2S,5R)-5-methyl-2-(1- (iii) Industrial, commercial, and con- methylethyl)cyclohexyl]oxy]methyl]- sumer activities. Requirements as speci- (PMN P-00–0330; CAS No. 249297–16–3) is fied in § 721.80(h). subject to reporting under this section (b) Specific requirements. The provi- for the significant new use described in sions of subpart A of this part apply to paragraph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Industrial, commercial, and con- (1) Recordkeeping. The following rec- sumer activities. Requirements as speci- ordkeeping requirements are applicable fied in § 721.80(g). to manufacturers, importers, and proc- (ii) Release to water. Requirements as essors of this substance, as specified in specified § 721.90 (a)(1), (b)(1), and (c)(1). § 721.125 (a), (b), (c), (d), (e), (f), and (i). (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this significant new paragraph. (1) Recordkeeping. Recordkeeping reuse rule. quirements as specified in § 721.125 (a), [55 FR 46774, Nov. 6, 1990. Redesignated at 58 (b), (c), (i), and (k) are applicable to FR 29947, May 24, 1993, as amended at 58 FR manufacturers, importers, and proc- 34204, June 23, 1993] essors of this substance. (2) Limitations or revocation of certain § 721.5625 Oxiranemethanamine, N,N′- notification requirements. The provisions [methylenebis(2-ethyl-4,1-phen- of § 721.185 apply to this section. ylene)]bis[N-(oxiranylmethyl)]-. [68 FR 15086, Mar. 28, 2003] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.5600 Substituted oxirane. chemical substance identified as oxiranemethanamine, N,N′- (a) Chemical substance and significant [methylenebis(2-ethyl-4,1-phen- new uses subject to reporting. (1) The chemical substance identified generi- ylene)]bis[N-(oxiranylmethyl)]- (PMN cally as substituted oxirane (PMN P- P-91–411; CAS number 130728–76–6) is 83–1157) is subject to reporting under subject to reporting under this section this section for the significant new for the significant new uses described uses described in paragraph (a)(2) of in paragraph (a)(2) of this section. this section. (2) The significant new uses are: (2) The significant new uses are: (i) Protection in the workplace. Re- (i) Protection in the workplace. Re- quirements as specified in § 721.63 (a)(1), quirements as specified in § 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 per- (a)(3), (a)(4), (a)(5)(i) through (a)(5)(iii), cent), and (c). (a)(6)(v), (a)(6)(vi), (b) (concentration (ii) Hazard communication program. set at 0.1 percent), and (c). Requirements as specified in § 721.72 (a), (ii) Hazard communication program. (b), (c), (d), (e) (concentration set at 0.1 Requirements as specified in § 721.72 (d), percent), (f), (g)(1)(vi), (g)(1)(vii), (e) (concentration set at 0.1 percent), (g)(2)(i), (g)(2)(v), and (g)(5).

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(iii) Industrial, commercial, and con- (PMN P-95–1750) is subject to reporting sumer activities. Requirements as speci- under this section for the significant fied in § 721.80 (f), (o), and (q). new uses described in paragraph (a)(2) (b) Specific requirements. The provi- of this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Industrial, commercial and consumer paragraph. activities. Requirements as specified in (1) Recordkeeping requirements. Re- § 721.80(o). quirements as specified in § 721.125 (a) (ii) [Reserved] through (i) are applicable to manufac- (b) Specific requirements. The provi- turers, importers, and processors of sions of subpart A of this part apply to this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), (3) Determining whether a specific use is (b), (c), and (i) are applicable to manu- subject to this section. The provisions of facturers, importers, and processors of § 721.1725(b)(1) apply to this section. this substance. (2) Limitations or revocation of certain [57 FR 44070, Sept. 23, 1992. Redesignated and amended at 58 FR 29946, 29947, May 24, 1993; 58 notification requirements. The provisions FR 34204, June 23, 1993] of § 721.185 apply to this section. [63 FR 3431, Jan. 22, 1998] § 721.5645 Pentane 1,1,1,2,3,4,4,5,5,5,- decafluoro. § 721.5700 Pentanenitrile, 3-amino-. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified as pen- chemical substance identified as tane 1,1,1,2,3,4,4,5,5,5,-decafluoro (PMN pentanenitrile, 3-amino- (PMN P-91– P-95–638 and SNUN P-97–79; CAS No. 222; CAS number 75405–06–0) is subject 138495–42–8) is subject to reporting to reporting under this section for the under this section for the significant significant new uses described in para- new uses described in paragraph (a)(2) graph (a)(2) of this section. of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Protection in the workplace. Re- (i) Industrial, commercial, and con- quirements as specified in § 721.63 (a)(1), sumer activities. Requirements as speci- (a)(2)(i), (a)(3), (a)(4), during both drum- fied in § 721.80(j) and uses other than as ming and transfer of the substance re- described in the significant new use no- quirements as specified in § 721.63 tice. (a)(5)(i), (a)(5)(ii), and (a)(5)(iii) apply, (ii) [Reserved] and during transfer (but not drum- (b) Specific requirements. The provi- ming) of the substance, requirements sions of subpart A of this part apply to as specified in § 721.63 (a)(5)(xii), this section except as modified by this (a)(5)(xiii), (a)(5)(xiv), and (a)(5)(xv) paragraph. apply following submittal by the com- (1) Recordkeeping. Recordkeeping re- pany, and written approval by the quirements as specified in § 721.125 (a), EPA, of the results of cartridge service (b), (c), and (i) are applicable to manu- life testing performance in accordance facturers, importers, and processors of with Interim Recommendations for Deter- this substance. mining Organic Vapor Cartridge Service (2) Limitations or revocation of certain Life for Category 23C Respirators (avail- notification requirements. The provisions able through the TSCA Assistance Of- of § 721.185 apply to this section. fice), or equivalent, which dem- [63 FR 3431, Jan. 22, 1998] onstrates the effectiveness of the organic vapor cartridge, (a)(6)(v), (b) § 721.5650 Pentanediol light residues. (concentration set at 1.0 percent), and (a) Chemical substance and significant (c). The requirements specified in new uses subject to reporting. (1) The § 721.63(a) (4) and (5) apply only during chemical substance identified generi- drumming activities and during trans- cally as pentanediol light residues fer of liquid PMN substance from a

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process vessel into a tank, truck, or § 721.5710 Phenacetin. rail car. (a) Chemical substance and signifi- (ii) Hazard communication program. cant new use subject to reporting. (1) Requirements as specified in § 721.72 (a), The chemical substance phenacetin (b), (c), (d), (e) (concentration set at 1.0 (CAS No. 62–442) is subject to reporting percent), (f), (g)(1)(i), (g)(1)(ix), (g)(2)(i), under this section for the significant (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), new use described in paragraph (a)(2) of and (g)(5). this section. (iii) Industrial, commercial, and con- (2) The significant new use is: Manu- sumer activities. Requirements as speci- facture, import, or processing of 10,000 fied in § 721.80(q). pounds or more per year per facility for (b) Specific requirements. The provi- any use. sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping requirements. Re- paragraph. quirements as specified in § 721.125 (a) (1) Recordkeeping. The following rec- through (i) are applicable to manufac- ordkeeping requirements are applicable turers, importers, and processors of to manufacturers, importers, and proc- this substance. essors of this substance, as specified in (2) Limitations or revocation of certain § 721.125 (a), (b), and (c). notification requirements. The provisions (2) [Reserved] of § 721.185 apply to this section. (3) Determining whether a specific use is [58 FR 63517, Dec. 1, 1993] subject to this section. The provisions of § 721.5713 Phenol - biphenyl polymer § 721.1725(b)(1) apply to this section. condensate (generic). [57 FR 44069, Sept. 23, 1992, as amended at 58 (a) Chemical substance and significant FR 29946, May 24, 1993; 58 FR 34204, June 23, new uses subject to reporting. (1) The 1993] chemical substance identified generically as a phenol - biphenyl polymer § 721.5708 2-Pentene, 1,1,1,2,3,4,4,5,5,5- decafluoro-. condensate (PMN P-00–1220) is subject to reporting under this section for the (a) Chemical substance and significant significant new use described in para- new uses subject to reporting. (1) The graph (a)(2) of this section. chemical substance identified as 2- (2) The significant new uses are: Pentene, 1,1,1,2,3,4,4,5,5,5-decafluoro- (i) Release to water. Requirements as (PMN P-95–637; CAS No.72804–49–0) is specified § 721.90(a)(1), (b)(1), and (c)(1). subject to reporting under this section (ii) [Reserved] for the significant new uses described (b) Specific requirements. The provi- in paragraph (a)(2) of this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Industrial, commercial, and con- paragraph. sumer activities. Requirements as speci- (1) Recordkeeping. Recordkeeping re- fied in § 721.80(j). quirements as specified in § 721.125(a), (ii) [Reserved] (b), (c), and (k) are applicable to manu- (b) Specific requirements. The provi- facturers, importers, and processors of sions of subpart A of this part apply to this chemical substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements specified in § 721.125 (a), (b), [68 FR 70179, Dec. 17, 2003] (c), and (i) are applicable to manufacturers, importers, and processors of § 721.5740 Phenol, 4,4′-methylenebis this substance. (2,6-dimethyl-. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified as Phe- [63 FR 3431, Jan. 22, 1998] nol, 4,4′-methylenebis (2,6-dimethyl-

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(PMNs P-88–864, P-90–211, and P-94–921; (i) Hazard communication program. Re- CAS No. 5384–21–4) is subject to report- quirements as specified in § 721.72 (b)(2), ing under this section for the signifi- (f), (g)(3)(ii), and (g)(4)(iii). The provi- cant new uses described in paragraph sion of § 721.72(g) requiring placement (a)(2) of this section. of specific information on an MSDS (2) The significant new uses are: does not apply when an MSDS is not (i) Protection in the workplace. Re- required under § 721.72(c). quirements as specified in § 721.63 (a)(1), (ii) Release to water. Requirements as (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), specified in § 721.90(a)(1). (a)(5)(v), (a)(6)(i), (b) (concentration set (b) Specific requirements. The provi- at 1 percent), and (c). sions of subpart A of this part apply to (ii) Hazard communication program. this section except as modified by this Requirements as specified in § 721.72 (a), paragraph. (b), (c), (d), (e) (concentration set at 1 (1) Recordkeeping. The following rec- percent), (f), (g)(1)(iv), (g)(2)(iv), ordkeeping requirements are applicable (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and (g)(5). to manufacturers, importers, and proc- The label and MSDS as required by this essors of this substance: Recordkeeping paragraph shall also include the fol- requirements specified in § 721.125 (a), lowing statements: This substance may (b), (c), (f), (g), and (j). cause blood effects. This substance (2) Limitations or revocation of certain may cause chronic effects. notification requirements. The provisions (iii) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as speci- [55 FR 33306, Aug. 15, 1990. Redesignated at 58 fied in § 721.80 (g), (l), and (q). FR 29947, May 24, 1993, as amended at 58 FR (iv) Release to water. Requirements as 34204, June 23, 1993] specified in § 721.90 (a)(1), (b)(1), and (c)(1). § 721.5762 Aromatic aldehyde phenolic (b) Specific requirements. The provi- resin (generic). sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified generi- (1) Recordkeeping. Recordkeeping re- cally as aromatic aldehyde phenolic quirements as specified in § 721.125 (a), resin (PMN P-01–573) is subject to re- (b), (c), (d), (e), (f), (g), (h), (i), and (k) porting under this section for the sig- are applicable to manufacturers, im- nificant new uses described in para- porters, and processors of this sub- graph (a)(2) of this section. stance. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Release to water. Requirements as notification requirements. The provisions specified in § 721.90(a)(1), (b)(1), and of § 721.185 apply to this section. (c)(1) (3) Determining whether a specific use is (ii) [Reserved] subject to this section. The provisions of (b) Specific requirements. The provi- § 721.1725(b)(1) apply to this section. sions of subpart A of this part apply to this section except as modified by this [55 FR 33306, Aug. 15, 1990. Redesignated and paragraph. amended at 58 FR 29946, 29947, May 24, 1993; 58 (1) Recordkeeping. Recordkeeping re- FR 34204, June 23, 1993; 63 FR 45956, Aug. 28, 1998] quirements as specified in ’ 721.125(a), (b), (c), and (k) are applicable to manu- § 721.5760 Phenol, 4,4′-[methylenebis facturers, importers, and processors of (oxy-2,1-ethanediylthio)]bis-. this chemical substance. (a) Chemical substances and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance phenol, 4,4′- of § 721.185 apply to this section. [methylenebis(oxy 2,1-ethanediyl- [68 FR 70179, Dec. 17, 2003] thio)]bis- (PMN P-87–1760) is subject to reporting under this section for the sig- § 721.5763 Methylenebisbenzotriazolyl nificant new uses described in para- phenols. graph (a)(2) of this section. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The

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chemical substance identified generi- this section except as modified by this cally as methylenebisbenzotriazolyl paragraph. phenols (P-94–1042) is subject to report- (1) Recordkeeping. Recordkeeping re- ing under this section for the signifi- quirements as specified in § 721.125 (a), cant new uses described in paragraph (b), (c), and (k) are applicable to manu- (a)(2) of this section. facturers, importers, and processors of (2) The significant new uses are: this substance. (i) Protection in the workplace. Re- (2) Limitations or revocation of certain quirements as specified in § 721.63 (a)(4), notification requirements. The provisions (a)(6)(i), (b) (concentration set at 1.0 of § 721.185 apply to this section. percent), and (c). Requirements as [60 FR 45083, Aug. 30, 1995] specified in § 721.63(a)(5)(i) apply during manufacture of the PMN substance. § 721.5775 Phenol, 5-amino-2,4- Requirements as specified in § 721.63 dicholoro-, hydrochloride. (a)(5)(iii) through (a)(5)(vii) apply dur- (a) Chemical substance and significant ing use of the PMN substance. new uses subject to reporting. (1) The (ii) Hazard communication program. chemical substance identified as phe- Requirements as specified in § 721.72 (a), nol, 5-amino-2,4-dicholoro-, hydro- (b), (c), (d), (e) (concentration set at 1.0 chloride (PMN P-98–198) is subject to percent), (f), (g)(1)(iv), (g)(1)(vi), reporting under this section for the sig- (g)(2)(iii), (g)(2)(iv), and (g)(5). nificant new uses described in para- (iii) Industrial, commercial, and con- graph (a)(2) of this section. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80 (l) and (q). (i) Industrial, commercial, and con- (b) Specific requirements. The provi- sumer activities. Requirements as speci- sions of subpart A of this part apply to fied in § 721.80 (v)(i), (w)(i), and (x)(i). this section except as modified by this (ii) Release to water. Requirements as paragraph. specified in § 721.90 (a)(1), (b)(1), and (1) Recordkeeping. Recordkeeping re- (c)(1). quirements as specified in § 721.125 (a) (b) Specific requirements. The provi- through (d) and (f) through (i) are ap- sions of subpart A of this part apply to plicable to manufacturers, importers, this section except as modified by this and processors of these substances. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), (i), and (k) are applicable to (3) Determining whether a specific use is manufacturers, importers, and proc- subject to this section. The provisions of essors of this substance. § 721.575(b)(1) apply to this section. (2) Limitations or revocation of certain [60 FR 45083, Aug. 30, 1995] notification requirements. The provisions of § 721.185 apply to this section. § 721.5769 Mixture of nitrated [63 FR 44579, Aug. 20, 1998] alkylated phenols. (a) Chemical substance and significant § 721.5780 Phenol, 4,4′-(oxybis(2,1- new uses subject to reporting. (1) The ethanediylthio)bis-. chemical substance identified as a mix- (a) Chemical substance and significant ture of nitrated alkylated phenols new uses subject to reporting. (1) The (PMN P-93–987) is subject to reporting chemical substance phenol, 4,4′- under this section for the significant (oxybis(2,1-ethanediylthio)bis- (PMN P- new uses described in paragraph (a)(2) 89–651) is subject to reporting under of this section. this section for the significant new (2) The significant new uses are: uses described in paragraph (a)(2) of (i) Release to water. Requirements as this section. specified in § 721.90 (a)(4), (b)(4), and (2) The significant new uses are: (c)(4) (where n = 1). (i) Protection in the workplace. Re- (ii) [Reserved] quirements as specified in § 721.63 (a)(1), (b) Specific requirements. The provi- (a)(3), (a)(4), (a)(5)(iv), (a)(6)(i), (b) (con- sions of subpart A of this part apply to centration set at 1.0 percent), and (c).

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(ii) Hazard communication program. the substance is reintroduced into the Requirements as specified in § 721.72 (a), workplace. (b), (c), (d), (e) (concentration set at 1.0 (B) The employer must ensure that percent), (f), (g)(1)(iii), (g)(1)(iv), persons who will receive this substance (g)(1)(ix), (g)(2)(iv), and (g)(2)(v). from the employer are provided an (iii) Industrial, commercial, and con- MSDS as described in § 721.72(c) consumer activities. Requirements as speci- taining the information required under fied in § 721.80(r) (82,000 kg; 141,000 kg; paragraph (a)(1)(i)(A) of this section and 272,000 kg with testing required at within 90 days from the time the em- each interval). ployer becomes aware of the new infor- (b) Specific requirements. The provi- mation. sions of subpart A of this part apply to (ii) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80(q). (1) Recordkeeping. The following rec- (b) Specific requirements. The provi- ordkeeping requirements are applicable sions of subpart A of this part apply to to manufacturers, importers, and proc- this section except as modified by this essors of this substance, as specified in paragraph. § 721.125 (a) through (i). (1) Recordkeeping requirements. Rec- (2) Limitations or revocation of certain ordkeeping requirements as specified notification requirements. The provisions in § 721.125 (a), (h), and (i) are applicable of § 721.185 apply to this significant new to manufacturers, importers, and proc- use rule. essors of this substance. [55 FR 39902, Sept. 28, 1990. Redesignated at (2) Limitations or revocation of certain 58 FR 29947, May 24, 1993, as amended at 58 notification requirements. The provisions FR 34204, June 23, 1993] of § 721.185 apply to this section. (3) Determining whether a specific use is § 721.5800 Sulfurized alkylphenol. subject to this section. The provisions of (a) Chemical substances and significant § 721.1725(b)(1) apply to this section. new uses subject to reporting. (1) The chemical substance described generi- [57 FR 4578, Feb. 6, 1992. Redesignated and cally as sulfurized alkylphenol (PMN amended at 58 FR 29946, 29947, May 24, 1993; 58 FR 34204, June 23, 1993] P-89–708) is subject to reporting under this section for the significant new § 721.5820 Aminophenol. uses described in paragraph (a)(2) of this section. (a) Chemical substances and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Hazard communication program. A chemical substance identified generi- significant new use of this substance is cally as aminophenol (P-83–909) is sub- any manner or method of manufacture, ject to reporting under this section for import, or processing associated with the significant new uses described in any use of this substance without pro- paragraph (a)(2) of this section. viding risk notification as follows: (2) The significant new uses are: (A) If as a result of the test data re- (i) Protection in the workplace. Re- quired under the section 5(e) consent quirements as specified in § 721.63 (a)(1) order for this substance, the employer and (a)(3). becomes aware that this substance (ii) Hazard communication program. may present a risk of injury to human Requirements as specified in § 721.72 health, the employer must incorporate (b)(1)(i)(D) and (g)(2)(v). The provision this new information, and any informa- of § 721.72(g) requiring placement of tion on methods for protecting against specific information in an MSDS does such risk, into an MSDS as described not apply when an MSDS is not rein § 721.72(c) within 90 days from the quired under § 721.72(c). time the employer becomes aware of (b) Specific requirements. The provi- the new information. If this substance sions of subpart A of this part apply to is not being manufactured, imported, this section except as modified by this processed, or used in the employer’s paragraph. workplace, the employer must add the (1) Recordkeeping. The following rec- new information to an MSDS before ordkeeping requirements are applicable

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to manufacturers, importers, and proc- (a)(3), (b) (concentration set at 1.0 per- essors of this substance: § 721.125 (a), cent), and (c). (b), (c), (d), (f), and (g). (ii) Hazard communication program. (2) Limitations or revocation of certain Requirements as specified in § 721.72 (a), notification requirements. The provisions (b)(2), (c), (d), (e) (concentration set at of § 721.185 apply to this section. 1.0 percent), (f), (g)(1)(ii), (g)(1)(iv), [56 FR 25989, June 5, 1991. Redesignated at 58 (g)(2)(i), and (g)(2)(v). FR 29946, May 24, 1993, as amended at 58 FR (iii) Industrial, commercial, and con- 34204, June 23, 1993] sumer activities. Requirements as speci- § 721.5840 Ethylated aminophenol. fied in § 720.80 (k) (antioxidant/stabilizer for polymers) and (q). (a) Chemical substances and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as ethylated aminophenol (P-83– 908) is subject to reporting under this paragraph. section for the significant new uses de- (1) Recordkeeping. The following rec- scribed in paragraph (a)(2) of this sec- ordkeeping requirements are applicable tion. to manufacturers, importers, and proc- (2) The significant new uses are: essors of this substance, as specified in (i) Protection in the workplace. Re- § 721.125 (a) through (i). quirements as specified in § 721.63 (a)(1) (2) Limitations or revocation of certain and (a)(3). notification requirements. The provisions (ii) Hazard communication program. of § 721.185 apply to this significant new Requirements as specified in § 721.72 use rule. (b)(1)(i)(D) and (g)(2)(v). The provision (3) Determining whether a specific use is of § 721.72(g) requiring placement of subject to this section. The provisions of specific information in an MSDS does § 721.1725(b)(1) apply to this section. not apply when an MSDS is not required under § 721.72(c). [56 FR 25991, June 5, 1991. Redesignated and (b) Specific requirements. The provi- amended at 58 FR 29946, May 24, 1993; 58 FR sions of subpart A of this part apply to 34204, June 23, 1993] this section except as modified by this paragraph. § 721.5867 Substituted phenol. (1) Recordkeeping. The following rec- (a) Chemical substance and significant ordkeeping requirements are applicable new uses subject to reporting. (1) The to manufacturers, importers, and proc- chemical substance generically identi- essors of this substance: § 721.125 (a), fied as substituted phenol (PMNs P-89– (b), (c), (d), (f), and (g). 1125, P-91–87, P-92–41, P-92–511, P-94– (2) Limitations or revocation of certain 1527, and P-94–1755) is subject to report- notification requirements. The provisions ing under this section for the signifi- of § 721.185 apply to this section. cant new uses described in paragraph [56 FR 25989, June 5, 1991. Redesignated at 58 (a)(2) of this section. FR 29946, May 24, 1993, as amended at 58 FR (2) The significant new uses are: 34204, June 23, 1993] (i) Industrial, commercial, and consumer activities. Requirements as speci- § 721.5860 Methylphenol, bis(substituted)alkyl. fied in § 721.80(j) (ingredient in a photoresist formulation). (a) Chemical substance and significant (ii) [Reserved] new uses subject to reporting. (1) The chemical substance identified generi- (b) Specific requirements. The provi- cally as methylphenol, sions of subpart A of this part apply to bis(substituted)alkyl (P-84–417) is this section except as modified by this subject to reporting under this section paragraph. for the significant new uses described (1) Recordkeeping. Recordkeeping rein paragraph (a)(2) of this section. quirements as specified in § 721.125 (a), (2) The significant new uses are: (b), (c), and (i) are applicable to manu- (i) Protection in the workplace. Re- facturers, importers, and processors of quirements as specified in § 721.63 (a)(1), this substance.

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(2) Limitations or revocation of certain (a)(3), (a)(4), (a)(5)(iii) through notification requirements. The provisions (a)(5)(vii) and (a)(6)(i), (b) [concentra- of § 721.185 apply to this section. tion set at 0.1 percent], and (c). (ii) Hazard communication program. [63 FR 23679, Apr. 30, 1998] Requirements as specified in § 721.72 (a), § 721.5880 Sulfur bridged substituted (d), (e) [concentration set at 0.1 per- phenols (generic name). cent], (f), (g)(1)(vii), and (g)(2)(i), (a) Chemical substance and significant (g)(2)(ii), (g)(2)(iv), and (g)(2)(v). The new uses subject to reporting. (1) The provision of § 721.72(d) requiring that chemical substance sulfur bridged sub- employees be provided with informa- stituted phenols (PMN P-89–396) is sub- tion on the location and availability of ject to reporting under this section for MSDSs does not apply when a MSDS the significant new uses described in was not required under § 721.72(c). The paragraph (a)(2) of this section. provisions of § 721.72(g) requiring place- (2) The significant new uses are: ment of specific information on a label (i) Protection in the workplace. Re- and MSDS do not apply when a label quirements as specified in § 721.63 (a)(1), and MSDS are not required under (a)(2)(i), (a)(3), (b) (concentration set at § 721.72 (b) and (c), respectively. 1.0 percent), and (c). (iii) Industrial, commercial, and con- (ii) Hazard communication program. sumer activities. Requirements as speci- Requirements as specified in § 721.72 (a), fied in § 721.80(k). (b), (c), (d), (e) (concentration set at 1.0 (b) Specific requirements. The provi- percent), (f), (g)(1)(iv) (specifically liver sions of subpart A of this part apply to and blood effects), (g)(2)(i), (g)(2)(v), this section except as modified by this and (g)(5). paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. The following rec- sions of subpart A of this part apply to ordkeeping requirements are applicable this section except as modified by this to manufacturers, importers, and proc- paragraph. essors of this substance, as specified in (1) Recordkeeping requirements. The § 721.125 (a) through (i). recordkeeping requirements as speci- (2) Limitations or revocation of certain fied in § 721.125 (a) and (c) through (h) notification requirements. The provisions are applicable to manufacturers and of § 721.185 apply to this significant new importers of this substance. Any state- use rule. ments requiring processors to keep (3) Determining whether a specific use is records in § 721.125 do not apply. subject to this section. The provisions of (2) Limitations or revocation of certain § 721.1725(b)(1) apply to this section. notification requirements. The provisions [55 FR 26111, June 26, 1990. Redesignated and of § 721.185 apply to this section. amended at 58 FR 29946, 29947, May 24, 1993; 58 (3) Determining whether a specific use is FR 34204, June 23, 1993] subject to this section. The provisions of § 721.1725(b)(1) apply to this section. § 721.5905 Modified phenolic resin (generic). [55 FR 32417, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, 29947, May 24, 1993; 58 (a) Chemical substance and significant FR 34204, June 23, 1993; 59 FR 40260, Aug. 8, new uses subject to reporting. (1) The 1994] chemical substance identified generically as a modified phenolic resin § 721.5900 Trisubstituted phenol (ge- (PMN P-01–441) is subject to reporting neric name). under this section for the significant (a) Chemical substance and significant new use described in paragraph (a)(2) of new uses subject to reporting. (1) The this section. chemical substance trisubstituted phe- (2) The significant new uses are: nol (PMN P-85–605) is subject to report- (i) Release to water. Requirements as ing under this section for the signifi- specified § 721.90(a)(1), (b)(1), and (c)(1). cant new uses described in paragraph (ii) [Reserved] (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 (a)(1), paragraph.

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(1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (b), (c), and (i) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this chemical substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [68 FR 70179, Dec. 17, 2003] [65 FR 81402, Dec. 26, 2000]

§ 721.5908 Modified phenolic resin (ge- § 721.5913 Phenothiazine derivative. neric). (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified generically as a phenothiazine derivative cally as modified phenolic resin (PMN (PMN P-96–813) is subject to reporting P-01–561) is subject to reporting under under this section for the significant this section for the significant new use new uses described in paragraph (a)(2) described in paragraph (a)(2) of this of this section. section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial, and con- (i) Release to water. Requirements as sumer activities. Requirements as speci- specified § 721.90(a)(1), (b)(1), and (c)(1). fied in § 721.80(f). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125(a), (1) Recordkeeping. Recordkeeping re- (b), (c), and (k) are applicable to manu- quirements as specified in § 721.125 (a) facturers, importers, and processors of and (i) are applicable to manufactur- this chemical substance. ers, and importers of this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [68 FR 70180, Dec. 17, 2003] [63 FR 3432, Jan. 22, 1998]

§ 721.5912 Phenoxazin-5-ium, 3- § 721.5914 Polysubstituted bis dialkylamino-7-arylamino-, salt (ge- phenylazonapthalene disulfonic neric). acid (generic). (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified generically as Phenoxazin-5-ium, 3- cally as a Polysubstituted bis dialkylamino-7-arylamino-, salt (PMN phenylazonapthalene disulfonic acid. P-99–0723) is subject to reporting under (PMN P-99–0479) is subject to reporting this section for the significant new under this section for the significant uses described in paragraph (a)(2) of new use described in paragraph (a)(2) of this section. this section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial, and con- (i) Industrial, commercial, and consumer activities. Requirements as speci- sumer activities. Requirements as specified in § 721.80(f). fied in § 721.80(f). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph.

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(1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125 (a), paragraph. (b), (c), and (i) are applicable to manu- (1) Recordkeeping. Recordkeeping re- facturers, importers, and processors of quirements as specified in § 721.125(a), this substance. (b), (c), and (i) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this chemical substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [65 FR 81402, Dec. 26, 2000] of § 721.185 apply to this section. § 721.5915 Polysubstituted [68 FR 70180, Dec. 17, 2003] phenylazopolysubstitutedphenyl dye. § 721.5920 (a) Chemical substance and significant Phenyl(disubstitutedpolycyclic). new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as a polysubstituted chemical substance identified generi- phenylazopolysubstitutedphenyl dye cally as (PMN P-93–658) is subject to reporting phenyl(disubstitutedpolycyclic) (PMN under this section for the significant P-92–1337) is subject to reporting under new uses described in paragraph (a)(2) this section for the significant new of this section. uses described in paragraph (a)(2) of (2) The significant new uses are: (i) this section. Industrial, commercial and consumer ac- (2) The significant new uses are: (i) tivities. Requirements as specified in Release to water. Requirements as speci- § 721.80 (w)(1), (w)(2), (x)(1), and (x)(2). fied in § 721.90 (a)(4), (b)(4), and (c)(4) (ii) [Reserved] (where N = 10 ppb). (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [58 FR 51706, Oct. 4, 1993] [58 FR 51706, Oct. 4, 1993] § 721.5925 Bis heterocyclic phenylene § 721.5917 Phenyl azo dye (generic). derivative (generic). (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified generically as a phenyl azo dye (PMN P-02–17) cally as bis heterocyclic phenylene de- is subject to reporting under this sec- rivative (PMN P-01–0432) is subject to tion for the significant new use de- reporting under this section for the sig- scribed in paragraph (a)(2) of this sec- nificant new use described in paragraph tion. (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial, and con- (i) Industrial, commercial, and consumer activities. Requirements as speci- sumer activities. Requirements as specified in § 721.80(v)(2), (w)(2), and (x)(2). fied in § 721.80(p) (20,000 kg/yr). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to

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this section except as modified by this (i) Protection in the workplace. Re- paragraph. quirements as specified in § 721.63(a)(1) (1) Recordkeeping. Recordkeeping re- and (a)(3). quirements as specified in § 721.125 (a), (ii) [Reserved] (b), (c), and (i) are applicable to manu- (b) Specific requirements. The provi- facturers, importers, and processors of sions of subpart A of this part apply to this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125(a), (b), (c), (d), and (e) are applicable to [68 FR 15086, Mar. 28, 2003] manufacturers, importers, and processors of this chemical substance. § 721.5930 Phenylenebis[imino (chlorotriazinyl)imino(substituted (2) Limitations or revocation of certain naphthyl)azo(substituted notification requirements. The provisions phenyl)azo, sodium salt (generic of § 721.185 apply to this section. name). [68 FR 70180, Dec. 17, 2003] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.5960 N,N′-Bis(2-(2-(3-alkyl)thia- chemical substance identified generi- zoline) vinyl)-1,4-phenylenediamine cally as phenylenebis[imino methyl sulfate double salt (generic (chlorotriazinyl)imino(substituted name). naphthyl)azo (substituted phenyl) azo, (a) Chemical substances and significant sodium salt (PMN P-95–274) is subject new uses subject to reporting. (1) The to reporting under this section for the chemical substance identified generi- significant new uses described in para- cally as N,N′-Bis(2-(2-(3- graph (a)(2) of this section. alkyl)thiazoline)vinyl)-1,4-phenylenedi- (2) The significant new uses are: amine methyl sulfate double salt (PMN (i) Industrial, commercial, and con- P-84–913) is subject to reporting under sumer activities. Requirements as speci- this section for the significant new fied in § 721.80(f). uses described in paragraph (a)(2) of (ii) [Reserved] this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 (a)(1), paragraph. (a)(3), (a)(4), (a)(5)(iii), (a)(5)(iv), (1) Recordkeeping. Recordkeeping re- (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(6)(i), quirements as specified in § 721.125 (a), (b) (concentration set at 1 percent), and (b), (c), and (i) are applicable to manu- (c). facturers, importers, and processors of (ii) Hazard communication program. this substance. Requirements as specified in § 721.72 (a), (2) Limitations or revocation of certain (b)(2), (c), (d), (e), (f) (concentration set notification requirements. The provisions at 1 percent), (g)(1)(iii), (g)(1), (may be of § 721.185 apply to this section. lethal if inhaled or in contact with eyes), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), [61 FR 63739, Dec. 2, 1996] (g)(2)(v), and (g)(5). The provision of § 721.72(d) requiring that employees be § 721.5935 Alkylated nitroso- provided with information on the loca- phenylenediamine (generic). tion and availability of MSDSs does (a) Chemical substance and significant not apply when an MSDS is not renew uses subject to reporting. (1) The quired under § 721.72(c). The provision chemical substance identified generi- of § 721.72(g) requiring placement of cally as alkylated nitroso- specific information on an MSDS does phenylenediamine (PMN P-00–636) is not apply when an MSDS in not re- subject to reporting under this section quired under § 721.72(c). for the significant new uses described (iii) Industrial, commercial, and con- in paragraph (a)(2) of this section. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80(j).

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(b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90(a)(4), (b)(4), and this section except as modified by this (c)(4) (where N = 600 ppb). paragraph. (ii) [Reserved] (1) Recordkeeping. The following rec- (b) Specific requirements. The provi- ordkeeping requirements are applicable sions of subpart A of this part apply to to manufacturers, importers, and proc- this section except as modified by this essors of this substance, as specified in paragraph. § 721.125 (a) through (i), and (k). (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of [55 FR 26098, June 26, 1990. Redesignated at 58 this substance. FR 29946, May 24, 1993, as amended at 58 FR (2) Limitations or revocation of certain 34204, June 23, 1993] notification requirements. The provisions of § 721.185 apply to this section. § 721.5965 Substituted S- phenylthiazole (generic). [59 FR 27485, May 27, 1994] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.5980 Dialkyl phosphorodithioate chemical substance identified generi- phosphate compounds. cally as substituted s-phenylthiazole (a) Chemical substance and significant (PMN P-97–1046) is subject to reporting new uses subject to reporting. (1) The under this section for the significant chemical substances identified generi- new uses described in paragraph (a)(2) cally as dialkyl phosphorodithioate of this section. phosphate compounds (P-90–1642 (2) The significant new uses are: through 1649) are subject to reporting (i) Industrial, commercial, and con- under this section for the significant sumer activities. Requirements as speci- new uses described in paragraph (a)(2) fied in § 721.80(f). of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Hazard communication program. A sions of subpart A of this part apply to significant new use of these substances this section except as modified by this is any manner or method of manufac- paragraph. ture, import, or processing associated (1) Recordkeeping. Recordkeeping re- with any use of these substances with- quirements as specified in § 721.125 (a), out providing risk notification as fol- (b), (c), and (i) are applicable to manu- lows: facturers, importers, and processors of (A) If as a result of the test data re- this substance. quired under the section 5(e) consent (2) Limitations or revocation of certain order for these substances, the em- notification requirements. The provisions ployer becomes aware that any of these of § 721.185 apply to this section. substances may present a risk of injury [63 FR 44580, Aug. 20, 1998] to human health, the employer must incorporate this new information, and § 721.5970 Phosphated polyarylphenol any information on methods for pro- ethoxylate, potassium salt. tecting against such risk, into an (a) Chemical substance and significant MSDS as described at § 721.72(c) within new uses subject to reporting. (1) The 90 days from the time the employer be- chemical substance identified generi- comes aware of the new information. If cally as phosphated polyarylphenol these substances are not being manu- ethoxylate, potassium salt (PMN P-93– factured, imported, processed, or used 1222) is subject to reporting under this in the employer’s workplace, the em- section for the significant new uses de- ployer must add the new information scribed in paragraph (a)(2) of this sec- to an MSDS before these substances tion. are reintroduced into the workplace. (2) The significant new uses are:

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(B) The employer must ensure that (2) Limitations or revocation of certain persons who have received, or will re- notification requirements. The provisions ceive, these substances from the em- of § 721.185 apply to this section. ployer are provided an MSDS as de- (3) Determining whether a specific use is scribed in § 721.72(c) containing the in- subject to this section. The provisions of formation required under paragraph § 721.1725(b)(1) apply to this section. (a)(2)(i)(A) within 90 days from the [65 FR 81402, Dec. 26, 2000] time the employer becomes aware of the new information. § 721.6000 Tris (2,3-dibromopropyl) (ii) Industrial, commercial, and con- phosphate. sumer activities. Requirements as speci- (a) Chemical substance and significant fied in § 721.80(q). new use subject to reporting. (1) The (b) Specific requirements. The provi- chemical substance tris (2,3- sions of subpart A of this part apply to dibromopropyl) phosphate (CAS Num- this section except as modified by this ber 126–72–7) is subject to reporting paragraph. under this section for the significant (1) Recordkeeping. The following rec- new use described in paragraph (a)(2) of ordkeeping requirements are applicable this section. to manufacturers, importers, and proc- (2) The significant new use is: Any essors of this substance, as specified in use. § 721.125 (a), (h), and (i). (b) Special provisions. The provisions (2) Limitations or revocation of certain of subpart A of this part apply to this notification requirements. The provisions section except as modified by this of § 721.185 apply to this significant new paragraph. use rule. (1) Persons who must report. Section (3) Determining whether a specific use is 721.5 applies to this section except for subject to this section. The provisions of § 721.5(a)(2). A person who intends to § 721.1725(b)(1) apply to this section. manufacture, import, or process for commercial purposes the substance [56 FR 40214, Aug. 13, 1991, as amended at 56 identified in paragraph (a)(1) of this FR 46729, Sept. 16, 1991. Redesignated and section and intends to distribute the amended at 58 FR 29946, 29947, May 24, 1993; 58 substance in commerce must submit a FR 34204, June 23, 1993] significant new use notice. § 721.5985 Fatty alkyl phosphate, al- (2) [Reserved] kali metal salt (generic). [52 FR 2703, Jan. 26, 1987. Redesignated at 53 (a) Chemical substance and significant FR 2845, Feb. 2, 1988. Further redesignated at new uses subject to reporting. (1) The 58 FR 29947, May 24, 1993, as amended at 58 FR 34204, June 23, 1993] chemical substance identified generically as a fatty alkyl phosphate, alkali § 721.6005 Rare earth phosphate (ge- metal salt (PMN P-99–0385) is subject to neric). reporting under this section for the sig- (a) Chemical substance and significant nificant new use described in paragraph new uses subject to reporting. (1) The (a)(2) of this section. chemical substances identified generi- (2) The significant new uses are: cally as rare earth phophate (PMNs P- (i) Industrial, commercial, and con- 99–1191 and P-99–1192) are subject to re- sumer activities. Requirements as speci- porting under this section for the sig- fied in § 721.80(j). nificant new use described in paragraph (ii) [Reserved] (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified in § 721.90 (a)(4), (b)(4), and paragraph. (c)(4) (N=10). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), and (i) are applicable to manu- sions of subpart A of this part apply to facturers, importers, and processors of this section except as modified by this this substance. paragraph.

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(1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of [56 FR 25991, June 5, 1991. Redesignated at 58 this substance. FR 29947, May 24, 1993, as amended at 58 FR (2) Limitations or revocation of certain 34204, June 23, 1993] notification requirements. The provisions of § 721.185 apply to this section. § 721.6045 Phosphinothioic acid, bis(2,4,4-trimethylpentyl)- (9CI). [68 FR 15086, Mar. 28, 2003] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.6020 Phosphine, dialkylyphenyl. chemical substance identified as (a) Chemical substances and significant phosphinothioic acid, bis(2,4,4- new uses subject to reporting. (1) The trimethylpentyl)- (9CI) (PMN P-96–1652; chemical substance identified generi- CAS No. 132767–86–3) is subject to re- cally as phosphine dialkylphenyl (P-83– porting under this section for the sig- 1023) is subject to reporting under this nificant new uses described in para- section for the significant new uses de- graph (a)(2) of this section. (2) The significant new uses are: scribed in paragraph (a)(2) of this sec- (i) Release to water. Requirements as tion. specified in § 721.90 (a)(4), (b)(4), and (2) The significant new uses are: (c)(4) (N = 10). When calculating the (i) Protection in the workplace. Re- surface water concentrations according quirements as specified in § 721.63 (a)(1), to the instructions in § 721.91, the state- (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), ment that the amount of the substance (a)(5)(iii), (a)(6)(i), (b) (concentration that will be released will be calculated set at 1 percent), and (c). before the substance enters control (ii) Hazard communication program. technology does not apply. Instead, if Requirements as specified in § 721.72 (a), the waste stream containing the sub- (b)(2), (d), (e) (concentration set at 1 stance will be treated using carbon ad- percent), (f), (g)(1)(iii), (g)(2)(i), sorption treatment before release, then (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and the amount of the substance reason- (g)(2)(v). The provision of § 721.72(d) re- ably likely to be removed from the quiring that employees be provided waste stream by such treatment may be subtracted in calculating the num- with information on the location and ber of kilograms released. No more availability of MSDSs does not apply than 99 percent removal efficiency may when an MSDS is not required under be attributed to such treatment. § 721.72(c). The provision of § 721.72(g) (ii) [Reserved] requiring placement of specific infor- (b) Specific requirements. The provi- mation in an MSDS does not apply sions of subpart A of this part apply to when an MSDS is not required under this section except as modified by this § 721.72(c). paragraph. (iii) Disposal. Requirements as speci- (1) Recordkeeping. Recordkeeping re- fied in § 721.85 (a)(2); (b)(2); and (c)(2). quirements as specified in § 721.125 (a), (iv) Release to Water. Requirements as (b), (c), and (k) are applicable to manu- specified in § 721.90 (a)(3), (b)(3), and facturers, importers, and processors of (c)(3). this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. [63 FR 3432, Jan. 22, 1998] (1) Recordkeeping. The following recordkeeping requirements are applicable § 721.6060 Alkylaryl substituted phosphite. to manufacturers, importers, and processors of this substance: § 721.125 (a) (a) Chemical substance and significant through (g), (i), (j), and (k). new uses subject to reporting. (1) The chemical substance identified generically as alkylaryl substituted

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phosphite (PMN P-91–899) is subject to § 721.6070 Alkyl phosphonate ammo- reporting under this section for the sig- nium salts. nificant new uses described in para- (a) Chemical substances and significant graph (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substances identified generi- (i) Hazard communication program. A cally as alkyl phosphonate ammonium significant new use of this substance is salts (PMNs P-93–725 and P-93–726) are any manner or method of manufacture, subject to reporting under this section import, or processing associated with for the significant new uses described any use of this substance without pro- in paragraph (a)(2) of this section. viding risk notification as follows: (2) The significant new uses are: (i) (A) If as a result of the test data re- Release to water. Requirements as speci- quired under the section 5(e) consent fied in § 721.90 (a)(4), (b)(4), and (c)(4) order for this substance, the employer (where N = 400 ppb). becomes aware that this substance (b) Specific requirements. The provi- may present a risk of injury to human sions of subpart A of this part apply to health, the employer must incorporate this section except as modified by this this new information, and any informa- paragraph. tion on methods for protecting against (1) Recordkeeping. Recordkeeping re- such risk, into an MSDS as described quirements as specified in § 721.125 (a), in § 721.72(c) within 90 days from the (b), (c), and (k) are applicable to manu- time the employer becomes aware of facturers, importers, and processors of the new information. If this substance this substance. is not being manufactured, imported, processed, or used in the employer’s (2) Limitations or revocation of certain workplace, the employer must add the notification requirements. The provisions new information to an MSDS before of § 721.185 apply to this section. the substance is reintroduced into the [58 FR 51707, Oct. 4, 1993] workplace. (B) The employer must ensure that § 721.6075 Phosphonic acid, 1,1- persons who have received, or will re- methylenebis-tetrakis(1- ceive, this substance from the em- methylethyl) ester. ployer are provided an MSDS as de- (a) Chemical substance and significant scribed in § 721.72(c) containing the in- new uses subject to reporting. (1) The formation required under paragraph chemical substance identified as phos- (a)(2)(i)(A) within 90 days from the phonic acid, 1,1-methylenebis- time the employer becomes aware of tetrakis(1-methylethyl) ester (PMN P- the new information. 95–168) is subject to reporting under (ii) Industrial, commercial, and con- this section for the significant new sumer activities. Requirements as speci- uses described in paragraph (a)(2) of fied in § 721.80(q). this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 (a)(1), paragraph. (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), (b) (1) Recordkeeping requirements. Rec- (concentration set at 0.1 percent), and ordkeeping requirements as specified (c). at § 721.125(a) are applicable to manu- (ii) Hazard communication program. facturers, importers, and processors of Requirements as specified in § 721.72 (a), this substance. (b), (c), (d), (e) (concentration set at 0.1 (2) Limitations or revocation of certain percent), (f), (g)(2)(i), (g)(2)(v), and notification requirements. The provisions (g)(5). The label and MSDS required by of § 721.185 apply to this section. this paragraph shall also include the (3) Determining whether a specific use is following statement: This substance subject to this section. The provisions of may cause mutagenicity. § 721.1725(b)(1) apply to this section. (b) Specific requirements. The provi- [57 FR 31969, July 20, 1992, as amended at 58 sions of subpart A of this part apply to FR 29946, May 24, 1993; 58 FR 34204, June 23, this section except as modified by this 1993] paragraph.

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(1) Recordkeeping. Recordkeeping re- (g)(2)(v). The provision of § 721.72(d) requirements as specified in § 721.125 (a) quiring that employees be provided through (h) are applicable to manufac- with information on the location and turers, importers, and processors of availability of MSDSs does not apply this substance. when a MSDS was not required under (2) Limitations or revocation of certain § 721.72(c). The provisions of § 721.72(g) notification requirements. The provisions requiring placement of specific infor- of § 721.185 apply to this section. mation on a label and MSDS do not apply when a label and MSDS are not [63 FR 3432, Jan. 22, 1998] required under § 721.72(b) and (c), re- § 721.6078 Substituted spectively. ethoxyethylamine phosphonate. (iii) Industrial, commercial, and con- (a) Chemical substance and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80(k). chemical substance identified generi- (b) Specific requirements. The provi- cally as a substituted sions of subpart A of this part apply to ethoxyethylamine phosphonate (PMN this section except as modified by this P-95–1950) is subject to reporting under paragraph. this section for the significant new (1) Recordkeeping. The following rec- uses described in paragraph (a)(2) of ordkeeping requirements are applicable this section. to manufacturers, importers, and proc- (2) The significant new uses are: essors of this substance, as specified in (i) Release to water. Requirements as § 721.125 (a) through (i). specified in § 721.90 (a)(1), (b)(1), and (2) Limitations or revocation of certain (c)(1). notification requirements. The provisions (ii) [Reserved] of § 721.185 apply to this significant new (b) Specific requirements. The provi- use rule. sions of subpart A of this part apply to (3) Determining whether a specific use is this section except as modified by this subject to this section. The provisions of paragraph. § 721.1725(b)(1) apply to this section. (1) Recordkeeping. Recordkeeping re- [55 FR 26111, June 26, 1990. Redesignated and quirements as specified in § 721.125 (a), amended at 58 FR 29946, 29947, May 24, 1993; 58 (b), (c), and (k) are applicable to manu- FR 34204, June 23, 1993] facturers, importers, and processors of this substance. § 721.6085 Phosphonocarboxylate salts. (2) Limitations or revocation of certain (a) Chemical substances and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substances identified generi- [63 FR 3433, Jan. 22, 1998] cally as phosphonocarboxylate salts (PMNs P-93–722, P-93–723, and P-93–724) § 721.6080 Phosphonium salt (generic are subject to reporting under this sec- name). tion for the significant new uses de- (a) Chemical substance and significant scribed in paragraph (a)(2) of this sec- new uses subject to reporting. (1) The tion. chemical substance phosphonium salt (2) The significant new uses are: (i) (PMN Number P-84–820) is subject to Release to water. Requirements as speci- reporting under this section for the sig- fied in § 721.90 (a)(4), (b)(4), and (c)(4) nificant new uses described in para- (where N = 1000 ppb). graph (a)(2) of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Protection in the workplace. Re- sions of subpart A of this part apply to quirements as specified in § 721.63 (a)(1) this section except as modified by this and (a)(3), (b) [concentration set at 1.0 paragraph. percent], and (c). (1) Recordkeeping. Recordkeeping re- (ii) Hazard communication program. quirements as specified in § 721.125 (a), Requirements as specified in § 721.72 (a), (b), (c), and (k) are applicable to manu- (d), (e) [concentration set at 1.0 per- facturers, importers, and processors of cent], (f), and (g)(1)(iii) and (g)(2)(i) and this substance.

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(2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (h), and (i) are applicable to manufacturers, importers, and processors of [58 FR 51707, Oct. 4, 1993] this substance. (2) Limitations or revocation of certain § 721.6090 Phosphoramide. notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The (3) Determining whether a specific use is chemical substance identified generi- subject to this section. The provisions of cally as phosphoramide (P-89–538) is § 721.1725(b)(1) apply to this section. subject to reporting under this section for the significant new uses described [58 FR 51686, Oct. 4, 1993] in paragraph (a)(2) of this section. § 721.6097 Phosphoric acid derivative (2) The significant new uses are: (generic name). (i) Hazard communication program. A (a) Chemical substance and significant significant new use of this substance is new uses subject to reporting. (1) The any manner or method of manufacture, chemical substance identified generi- import, or processing associated with cally as a phosphoric acid derivative any use of this substance without pro- (PMN P-95–284) is subject to reporting viding risk notification as follows: under this section for the significant (A) If as a result of the test data renew uses described in paragraph (a)(2) quired under the section 5(e) consent of this section. order for this substance, the employer (2) The significant new uses are: becomes aware that this substance (i) Release to water. Requirements as may present a risk of injury to human specified in § 721.90 (a)(1), (b)(1), and health, the employer must incorporate (c)(1). this new information, and any informa- (ii) [Reserved] tion on methods for protecting against (b) Specific requirements. The provi- such risk, into an MSDS as described sions of subpart A of this part apply to in § 721.72(c) within 90 days from the this section except as modified by this time the employer becomes aware of paragraph. the new information. If this substance (1) Recordkeeping. Recordkeeping re- is not being manufactured, imported, quirements as specified in § 721.125 (a), processed, or used in the employer’s (b), (c), and (k) are applicable to manu- workplace, the employer must add the facturers, importers, and processors of new information to an MSDS before this substance. the substance is reintroduced into the (2) Limitations or revocation of certain workplace. notification requirements. The provisions (B) The employer must ensure that of § 721.185 apply to this section. persons who will receive, or who have [61 FR 63739, Dec. 2, 1996] received this substance from the em-

ployer within 5 years from the date the § 721.6100 Phosphoric acid, C6-12-alkyl employer becomes aware of the new in- esters, compounds with 2- formation described under paragraph (dibutylamino) ethanol. (a)(2)(i)(A) of this section, are provided (a) Chemical substances and significant an MSDS as described in § 721.72(c) con- new uses subject to reporting. (1) The taining the information required under chemical substances identified as phos- paragraph (a)(2)(i)(A) of this section phoric acid, C6-12-alkyl esters, com- within 90 days from the time the em- pounds with 2-(dibutylamino)ethanol ployer becomes aware of the new infor- (PMN P-90–384) are subject to reporting mation. under this section for the significant (ii) Industrial, commercial, and con- new use described in paragraph (a)(2) of sumer activities. Requirements as speci- this section. fied in § 721.80(q). (2) The significant new use is: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(4), (b)(4), and this section except as modified by this (c)(4) (concentration set at 700 ppb). paragraph. (ii) [Reserved]

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(b) Specific requirements. The provi- this section for the significant new sions of subpart A of this part apply to uses described in paragraph (a)(2) of this section except as modified by this this section. paragraph. (2) The significant new uses are: (1) Recordkeeping. The following rec- (i) Protection in the workplace. Re- ordkeeping requirements are applicable quirements as specified in § 721.63 (a)(1), to manufacturers, importers, and proc- (a)(3), (a)(4), (a)(5)(iii), (a)(6)(v), (b) essors of this substance, as specified in (concentration set at 0.1 percent), and § 721.125 (a), (b), (c) and (k). (c). (2) Limitations or revocation of certain (ii) Hazard communication program. notification requirements. The provisions Requirements as specified in § 721.72 (a), of § 721.185 apply to this significant new (b)(2), (c), (d), (e) (concentration set at use rule. 0.1 percent), (f), (g)(1)(iii), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), and [56 FR 19239, Apr. 25, 1991. Redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR (g)(2)(v). 34204, June 23, 1993] (iii) Industrial, commercial, and consumer activities. Requirements as speci- § 721.6110 fied in § 721.80(k) (use other than as a Alkyldi(alkyloxyhydroxypropyl) de- flame retardant for polyurethane rivative, phosphoric acid esters, po- foams). tassium salts. (iv) Disposal. Requirements as speci- (a) Chemical substance and significant fied in § 721.85 (a)(1), (b)(1), and (c)(1). new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substance identified generi- sions of subpart A of this part apply to cally as an this section except as modified by this alkyldi(alkyloxyhydroxypropyl) deriv- paragraph. ative, phosphoric acid esters, potas- (1) Recordkeeping. The following rec- sium salts (PMN P-91–818) is subject to ordkeeping requirements are applicable reporting under this section for the sig- to manufacturers, importers, and proc- nificant new uses described in para- essors of this substance, as specified in graph (a)(2) of this section. § 721.125 (a) through (j). (2) The significant new uses are: (2) Limitations or revocation of certain (i) Industrial, commercial, and con- notification requirements. The provisions sumer activities. Requirements as speci- of § 721.185 apply to this section. fied in § 721.80 (f) and (o). [55 FR 33307, Aug. 15, 1990. Redesignated at 58 (ii) [Reserved] FR 29947, May 24, 1993, as amended at 58 FR (b) Specific requirements. The provi- 34204, June 23, 1993] sions of subpart A of this part apply to this section except as modified by this § 721.6140 Dialkyldithiophosphoric paragraph. acid, aliphatic amine salt. (1) Recordkeeping. Recordkeeping re- (a) Chemical substance and significant quirements as specified in § 721.125 (a), new uses subject to reporting. (1) The (b), (c), and (i) are applicable to manu- chemical substance identified generi- facturers, importers, and processors of cally as a dialkyldithiophosphoric acid, this substance. aliphatic amine salt (P-90–1839) is sub- (2) Limitations or revocation of certain ject to reporting under this section for notification requirements. The provisions the significant new uses described in of § 721.185 apply to this section. paragraph (a)(2) of this section. [60 FR 45084, Aug. 30, 1995] (2) The significant new uses are: (i) Hazard communication program. A § 721.6120 Phosphoric acid, 1,2-ethane- significant new use of this substance is diyl tetrakis(2-chloro-1-methylethyl) any manner or method of manufacture, ester. import, or processing associated with (a) Chemical substances and significant any use of this substance without pro- new uses subject to reporting. (1) The viding risk notification as follows: chemical substance identified as phos- (A) If as a result of the test data re- phoric acid, 1,2-ethanediyl tetrakis(2- quired under the section 5(e) consent chloro-1-methylethyl) ester (PMN P- order for this substance, the employer 861263) is subject to reporting under becomes aware that this substance

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may present a risk of injury to human for the significant new uses described health, the employer must incorporate in paragraph (a)(2) of this section. this new information, and any informa- (2) The significant new uses are: tion on methods for protecting against (i) Protection in the workplace. Re- such risk, into an MSDS as described quirements as specified in § 721.63 (a)(4), in § 721.72(c) within 90 days from the (a)(5)(iv) through (vii), (a)(6)(i), (b) time the employer becomes aware of (concentration set at 1.0 percent), and the new information. If this substance (c). is not being manufactured, imported, (ii) Hazard communication program. processed, or used in the employer’s Requirements as specified in § 721.72 (a), workplace, the employer must add the (b), (c), (d) (e) (concentration set at 1.0 new information to an MSDS before percent), (f), (g)(1)(iv), (g)(1)(vi), the substance is reintroduced into the (g)(1)(viii), (g)(2)(ii), (g)(2)(iv), and workplace. (g)(5). (B) The employer must ensure that (iii) Industrial, commercial, and con- persons will receive this substance sumer activities. Requirements as speci- from the employer are provided an fied in § 721.80(q). MSDS as described in § 721.72(c) con- (b) Specific requirements. The provi- taining the information required under sions of subpart A of this part apply to paragraph (a)(2)(i)(A) of this section this section except as modified by this within 90 days from the time the em- paragraph. (1) Re- ployer becomes aware of the new infor- Recordkeeping requirements. quirements as specified in § 721.125 (a) mation. through (d), and (f) through (i) are ap- (ii) Industrial, commercial, and con- plicable to manufacturers, importers, sumer activities. Requirements as speci- and processors of this substance. fied in § 721.80(q). (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this (3) Determining whether a specific use is paragraph. subject to this section. The provisions of (1) Recordkeeping requirements. Re- § 721.1725(b)(1) apply to this section. quirements as specified in § 721.125 (a), (h), and (i) are applicable to manufac- [57 FR 44069, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 58 FR 34204, June 23, turers, importers, and processors of 1993] this substance. (2) Limitations or revocation of certain § 721.6165 Polysubstituted piperidine. notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The (3) Determining whether a specific use is chemical substance identified generi- subject to this section. The provisions of cally as a polysubstituted piperdine § 721.1725(b)(1) apply to this section. (PMN P-93–568) is subject to reporting [57 FR 44069, Sept. 23, 1992, as amended at 58 under this section for the significant FR 29946, May 24, 1993; 58 FR 34204, June 23, new uses described in paragraph (a)(2) 1993] of this section. (2) The significant new uses are: § 721.6160 Piperazinone, 1,1′,1″-[1,3,5- (i) Release to water. Requirements as triazine-2,4,6- specified in § 721.90 (a)(4), (b)(4), and triyltris[(cyclohexylimino)-2,1- (c)(4) (N = 30). ethanediyl]]tris-[3,3,4,5,5- (ii) [Reserved] pentamethyl]-. (b) Specific requirements. The provi- (a) Chemical substance and significant sions of subpart A of this part apply to new uses subject to reporting. (1) The this section except as modified by this chemical substance identified as paragraph. piperazinone, 1,1′,1″-[1,3,5-triazine-2,4,6- (1) Recordkeeping. Recordkeeping re- triyltris [(cyclohexylimino)-2,1-ethane- quirements as specified in § 721.125 (a), diyl]]tris-[3,3,4,5,5-pentamethyl]- (PMN (b), (c), and (k) are applicable to manu- P-89–589; CAS number 130277–45–1) is facturers, importers, and processors of subject to reporting under this section this substance.

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(2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this paragraph. [63 FR 3433, Jan. 22, 1998] (1) Recordkeeping. Recordkeeping re- § 721.6167 Piperdinium, 1,1-dimethyl-, quirements as specified in § 721.125 (a), chloride. (b), (c), and (i) are applicable to manufacturers, importers, and processors of (a) Chemical substance and significant this substance. new uses subject to reporting. (1) The chemical substance identified as (2) Limitations or revocation of certain piperdinium, 1,1-dimethyl-, chloride. notification requirements. The provisions (PMN P-02–207; CAS No. 24307–26–4) is of § 721.185 apply to this section. subject to reporting under this section [63 FR 3433, Jan. 22, 1998] for the significant new use described in paragraph (a)(2) of this section. § 721.6175 2-Piperdinone, 1,3-dimethyl- (2) The significant new uses are: ,. (i) Industrial, commercial, and con- (a) Chemical substance and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80(j). chemical substance identified as 2- (ii) Release to water. Requirements as Piperdinone, 1,3-dimethyl-, (PMN P-97– specified in § 721.90(a)(1), (b)(1), and 520 and SNUN 00–397; CAS No. 1690–76–2) (c)(1). is subject to reporting under this sec- (b) Specific requirements. The provi- tion for the significant new uses de- sions of subpart A of this part apply to scribed in paragraph (a)(2) of this sec- this section except as modified by this tion. paragraph. (2) The significant new uses are: (1) Recordkeeping. Recordkeeping re- (i) Protection in the workplace. Re- quirements as specified in § 721.125(a), quirements as specified in § 721.63 (a)(1), (b), (c), (i), and (k) are applicable to (a)(2)(i), (a)(3), (b) (concentration set at manufacturers, importers, and proc- 1.0 percent), and (c). essors of this chemical substance. (ii) Hazard communication program. (2) Limitations or revocation of certain Requirements as specified in § 721.72 (a), notification requirements. The provisions (b), (c), (d), (e) (concentration set at 1.0 of § 721.185 apply to this section. percent), (f), (g)(1)(i), (g)(1)(iii), (3) Determining whether a specific use is (g)(1)(iv), (g)(1)(ix), (g)(2)(i), (g)(2)(v), subject to this section. The provisions of and (g)(5). § 721.1725(b)(1) apply to this section. (iii) Industrial, commercial, and con- [68 FR 70180, Dec. 17, 2003] sumer activities. Requirements as specified in § 721.80(k) (use or processing § 721.6170 Siloxanes and silicones, Me other than: in enclosed systems (such hydrogen, reaction products with as hydrocarbon extraction, polymer 2,2,6,6-tetramethyl-4-(2- synthesis, wire enamel resin); elec- propenyloxy)piperdine. tronic industry cleaning solvent; and (a) Chemical substance and significant other precision industry cleaning (such new uses subject to reporting. (1) The as automobile manufacturing, aero- chemical substance identified as space, and optics)), (o), and (q). siloxanes and silicones, Me hydrogen, (b) Specific requirements. The provi- reaction products with 2,2,6,6- sions of subpart A of this part apply to tetramethyl-4-(2-propenyloxy)piperdine this section except as modified by this (PMN P-95–1891; CAS No. 182635–99–0) is paragraph. subject to reporting under this section (1) Recordkeeping. The recordkeeping for the significant new uses described requirements specified in § 721.125 (a), in paragraph (a)(2) of this section. (b), (c), (d), (e), (f), (g), (h), and (i) are (2) The significant new uses are: applicable to manufacturers, import- (i) Industrial, commercial, and con- ers, and processors of this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80 (v)(1), (w)(1), and (x)(1). notification requirements. The provisions (ii) [Reserved] of § 721.185 apply to this section.

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(3) Determining whether a specific use is § 721.6178 Alkylaminated polyolefin subject to this section. The provisions of (generic). § 721.1725(b)(1) apply to this substance. (a) Chemical substance and significant [63 FR 44580, Aug. 20, 1998, as amended at 67 new uses subject to reporting. (1) The FR 12882, Mar. 20, 2002] chemical substance identified generically as alkylaminated polyolefin § 721.6176 2-Piperdinone, 1,5-dimethyl- (PMN P-99–1287) is subject to reporting ,. under this section for the significant (a) Chemical substance and significant new use described in paragraph (a)(2) of new uses subject to reporting. (1) The this section. chemical substance identified as 2- (2) The significant new uses are: Piperdinone, 1,5-dimethyl-, (PMN P-97– (i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and 521 and SNUN 00–398; CAS No. 86917–58– (c)(1). 0) is subject to reporting under this (ii) [Reserved] section for the significant new uses de- (b) Specific requirements. The provi- scribed in paragraph (a)(2) of this sec- sions of subpart A of this part apply to tion. this section except as modified by this (2) The significant new uses are: paragraph. (i) Protection in the workplace. Re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.63 (a)(1), quirements as specified in § 721.125 (a), (a)(2)(i), (a)(3), (b) (concentration set at (b), (c), and (k) are applicable to manu- 1.0 percent), and (c). facturers, importers, and processors of (ii) Hazard communication program. this substance. Requirements as specified in § 721.72 (a), (2) Limitations or revocation of certain (b), (c), (d), (e) (concentration set at 1.0 notification requirements. The provisions percent), (f), (g)(1)(i), (g)(1)(iii), of § 721.185 apply to this section. (g)(1)(iv), (g)(1)(ix), (g)(2)(i), (g)(2)(v), [68 FR 15087, Mar. 28 2003] and (g)(5). (iii) Industrial, commercial, and con- § 721.6180 Polyalkylene glycol poly- sumer activities. Requirements as speci- amide ester phosphate (generic). fied in § 721.80(k) (use or processing (a) Chemical substance and significant other than: in enclosed systems (such new uses subject to reporting. (1) The as hydrocarbon extraction, polymer chemical substance identified generi- synthesis, wire enamel resin); elec- cally as polyalkylene glycol polyamide tronic industry cleaning solvent; and ester phosphate (PMN P-98–0903) is sub- other precision industry cleaning (such ject to reporting under this section for as automobile manufacturing, aero- the significant new uses described in space, and optics)), (o), and (q). paragraph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified in § 721.90 (a)(1), (b)(1), and paragraph. (c)(1). (1) Recordkeeping. The recordkeeping (ii) [Reserved] requirements specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), (d), (e), (f), (g), (h), and (i) are sions of subpart A of this part apply to applicable to manufacturers, import- this section except as modified by this ers, and processors of this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of (3) Determining whether a specific use is this substance. subject to this section. The provisions of (2) Limitations or revocation of certain § 721.1725(b)(1) apply to this substance. notification requirements. The provisions [63 FR 44580, Aug. 20, 1998, as amended at 67 of § 721.185 apply to this section. FR 12882, Mar. 20, 2002] [65 FR 81402, Dec. 26, 2000]

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§ 721.6181 Fatty acid, reaction product this section except as modified by this with substituted oxirane, formalde- paragraph. hyde-phenol polymer glycidyl ether, (1) Recordkeeping. Recordkeeping re- substituted proplyamine and quirements as specified in § 721.125 (a), polyethylenepolyamines (generic). (b), (c), and (k) are applicable to manu- (a) Chemical substance and significant facturers, importers, and processors of new uses subject to reporting. (1) The this substance. chemical substance identified generi- (2) Limitations or revocation of certain cally as fatty acid, reaction product notification requirements. The provisions with substituted oxirane, formalde- of § 721.185 apply to this section. hyde-phenol polymer glycidyl ether, substituted proplyamine and [68 FR 15087, Mar. 28, 2003] polyethylenepolyamines (PMN P-98– § 721.6186 Polyamine dithiocarbamate. 1125) is subject to reporting under this section for the significant new use de- (a) Chemical substance and significant scribed in paragraph (a)(2) of this sec- new uses subject to reporting. (1) The tion. chemical substance identified generi- (2) The significant new uses are: cally as a polyamine dithiocarbamate (i) Release to water. Requirements as (PMN No. P-91–1328) is subject to re- specified in § 721.90 (a)(4), (b)(4), and porting under this section for the sig- (c)(4) (N=10ppb). nificant new uses described in para- (ii) [Reserved] graph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified in § 721.90 (a)(4), (b)(4), and paragraph. (c)(4) (where N = 50 ppb). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), and (k) are applicable to manu- sions of subpart A of this part apply to facturers, importers, and processors of this section except as modified by this this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (k) are applicable to manu- [68 FR 15087, Mar. 28, 2003] facturers, importers, and processors of this substance. § 721.6183 Amides, from ammonium (2) Limitations or revocation of certain hydroxide - maleic anhydride poly- notification requirements. The provisions mer and hydrogenated tallow alkyl of § 721.185 apply to this significant new amines, sodium salts, compds. with use rule. ethanolamine. (a) Chemical substance and significant [58 FR 32239, June 8, 1993] new uses subject to reporting. (1) The § 721.6193 Polyalkylene polyamine. chemical substance identified as amides, from ammonium hydroxide - ma- (a) Chemical substance and significant leic anhydride polymer and hydro- new uses subject to reporting. (1) The genated tallow alkyl amines, sodium chemical substance generically identi- salts, compds. with ethanolamine fied as a polyalkylene polyamine (PMN (PMN P-00–0691; CAS No. 208408–03–1) is P-89–963) is subject to reporting under subject to reporting under this section this section for the significant new for the significant new use described in uses described in paragraph (a)(2) of paragraph (a)(2) of this section. this section. (2) The significant new uses are: (2) The significant new uses are: (i) Release to water. Requirements as (i) Hazard communication program. Re- specified in § 721.90 (a)(4), (b)(4), and quirements as specified in § 721.72 (a), (c)(4) (N=80 ppb). (b), (c), (d), (f), (g)(3)(i), (g)(4) (users (ii) [Reserved] minimize release to water), and (g)(5) (b) Specific requirements. The provi- are applicable to manufacturers and sions of subpart A of this part apply to importers.

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(ii) Release to water. Requirements as (i) Release to water. Requirements as specified in § 721.90(a)(1). specified in § 721.90 (a)(1), (b)(1), and (b) Specific requirements. The provi- (c)(1). sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125 (a), paragraph. (b), (c), (f), (g), (h), (i), and (k) are ap- (1) Recordkeeping requirements. Re- plicable to manufacturers and import- quirements as specified in § 721.125 (a), ers of this substance. (b), (c), and (k) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain [62 FR 64740, Dec. 9, 1997] notification requirements. The provisions of § 721.185 apply to this section. § 721.6196 Hydrochloride salt of a fatty polyalkkylene polyamine (generic). [57 FR 46467, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.6205 Hexamethylenediamine chemical substance identified generi- adduct of substituted cally as Hydrochloride salt of a fatty piperidinyloxy (generic). polyalkkylene polyamine (PMN P-99– (a) Chemical substance and significant 0618) is subject to reporting under this new uses subject to reporting. (1) The section for the significant new use de- chemical substance identified generi- scribed in paragraph (a)(2) of this sec- cally as hexamethylenediamine adduct tion. of substituted piperidinyloxy (PMN P- (2) The significant new uses are: 99–0510) is subject to reporting under (i) Release to water. Requirements as this section for the significant new use specified in § 721.90 (a)(1), (b)(1), and described in paragraph (a)(2) of this (c)(1). section. (ii) [Reserved] (2) The significant new uses are: (b) The provi- Specific requirements. (i) Protection in the workplace. Re- sions of subpart A of this part apply to quirements as specified in § 721.63 (a)(i), this section except as modified by this (a)(2)(i), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), paragraph. (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (1) Recordkeeping. Recordkeeping re- (a)(5)(vii), (a)(5)(viii), (a)(5)(ix), quirements as specified in § 721.125 (a), (a)(5)(x), (a)(5)(xi), (a)(5)(xii), (a)(5)(xiii) (b), (c), and (k) are applicable to manu- (a)(5)(xiv), (a)(5)(xv), (a)(6)(i), (a)(6)(ii), facturers, importers, and processors of (a)(6)(iii), (a)(6)(iv), (a)(6)(v), and this substance. (a)(6)(vi), (b) (concentration set at 1.0 (2) Limitations or revocation of certain percent), and (c). The imperviousness notification requirements. The provisions of each item pursuant to paragraph of § 721.185 apply to this section. (a)(2)(i) must be demonstrated by ac- [65 FR 81402, Dec. 26, 2000] tual testing under paragraph (a)(3) and not by manufacturer specifications. § 721.6200 Fatty acid polyamine con- Permeation testing shall be conducted densate, phosphoric acid ester salts. according to the American Society for (a) Chemical substances and significant Testing and Materials (ASTM) F739 new uses subject to reporting. (1) The ‘‘Standard Test Method for Resistance chemical substances identified as fatty of Protective Clothing Materials to acid polyamine condensate, phosphate Permeation by Liquids or Gases’’ or its ester salts (PMNs P-90–1984 and P-90– equivalent. Results shall be recorded as 1985) are subject to reporting under a cumulative permeation rate as a this section for the significant new function of time, and shall be docu- uses described in paragraph (a)(2) of mented in accordance with ASTM F739 this section. using the format specified in ASTM (2) The significant new uses are: 1194–89 ‘‘Guide for Documenting the

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Results of Chemical Permeation Test- (PMN P-91–584) is subject to reporting ing on Protective Clothing Materials’’ under this section for the significant or its equivalent. Gloves may not be new uses described in paragraph (a)(2) used for a time period longer than they of this section. are actually tested and must be re- (2) The significant new uses are: placed at the end of each work shift. (i) Release to water. Requirements as The manufacturer, importer, or proc- specified in § 721.90 (a)(1), (b)(1), and essor must submit all test data to the (c)(1). Agency and must receive written Agen- (ii) [Reserved] cy approval for each type of glove tested prior to use of such gloves. The fol- (b) Specific requirements. The provi- lowing gloves have been tested in ac- sions of subpart A of this part apply to cordance with the ASTM F739 method this section except as modified by this and found to satisfy the requirements paragraph. for use by EPA: Latex (at least 14 mils (1) Recordkeeping requirements. Re- thick), Nitrile (at least 16 mils thick), quirements as specified in § 721.125 (a), and Silvershield (at least 3 mils thick). (b), (c), and (k) are applicable to manu- As an alternative to the respiratory re- facturers, importers, and processors of quirements listed here, a manufac- this substance. turer, importer, or processor may (2) Limitations or revocation of certain choose to follow the NCEL provisions notification requirements. The provisions listed in the TSCA section 5(e) consent of § 721.185 apply to this section. order for this substance. The NCEL is 0.2 ug/m3 as an 8-hour time weighted [57 FR 46467, Oct. 8, 1992, as amended at 58 FR average verified by actual monitoring 34204, June 23, 1993] data. (ii) Hazard communication program. § 721.6440 Polyamine ureaformalde- Requirements as specified in § 721.72 (a), hyde condensate (specific name). (b), (c), (d), (e) (concentration set at 0.1 (a) Chemical substance and significant percent), (f), (g)(1)(i), (g)(1)(ii), new uses subject to reporting. (1) The (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), (g)(2)(i), chemical substance polyamine (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5). ureaformaldehyde condensate (PMN P- (iii) Industrial, commercial, and con- 87–1456) is subject to reporting under sumer activities. Requirements as speci- this section for the significant new fied in § 721.80(q). uses described in paragraph (a)(2) of (b) Specific requirements. The provi- this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Release to water. Requirements as paragraph. specified in § 721.90 (a)(4) [concern level (1) Recordkeeping. Recordkeeping re- of 1 ppb], (b)(4) [concern level of 1 ppb], quirements as specified in § 721.125 (a), and (c)(4) [concern level of 1 ppb]. (b), (c), (d), (e), (f), (g), (h), and (i) are (ii) [Reserved] applicable to manufacturers, importers, and processors of this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. (3) Determining whether a specific use is (1) Recordkeeping. The following rec- subject to this section. The provisions of ordkeeping requirements are applicable § 721.1725(b)(1) apply to this section. to manufacturers, importers, and processors of this substance, as specified in [68 FR 15087, Mar. 28, 2003] § 721.125 (a), (b), (c), and (k). § 721.6220 Aryl sulfonate of a fatty acid (2) Limitations or revocation of certain mixture, polyamine condensate. notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this significant new new uses subject to reporting. (1) The use rule. chemical substance identified generi- [55 FR 26112, June 26, 1990. Redesignated at 58 cally as an aryl sulfonate of a fatty FR 29947, May 24, 1993, as amended at 58 FR acid mixture, polyamine condensate 34204, June 23, 1993]

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§ 721.6470 Polyaminopolyacid. (3) Chemical substance and significant The chem- (a) Chemical substance and significant new uses subject to reporting. new uses subject to reporting. (1) The ical substances identified generically chemical substance identified generi- as alkyl polycarboxylic acids, esters cally as a polyaminopolyacid (PMN No. with ethoxylated fatty alcohols (PMN P-92–491) is subject to reporting under P-96–560/561/564/565) are subject to re- this section for the significant new porting under this section for the sig- uses described in paragraph (a)(2) of nificant new uses described in para- this section. graph (a)(2) of this section. (2) The significant new uses are: (i) The significant new uses are: (i) Release to water. Requirements as (A) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and specified in § 721.90 (a)(1), (b)(1), and (c)(4) (concentration set at 500 ppb). (c)(1). (ii) [Reserved] (B) [Reserved] (b) Specific requirements. The provi- (ii) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (A) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. these substances. (2) Limitations or revocation of certain (B) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this significant new of § 721.185 apply to this section. use rule. [63 FR 3433, Jan. 22, 1998] [58 FR 32240, June 8, 1993] § 721.6477 Alkyl polycarboxylic acids, § 721.6475 Alkyl polycarboxylic acids, esters with ethoxylated fatty alco- esters with ethoxylated fatty alcohols, reaction products with maleic hols. anhydride. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substances identified generi- chemical substances identified generically as alkyl polycarboxylic acids, cally as alkyl polycarboxylic acids, esters with ethoxylated fatty alcohols esters with ethoxylated fatty alcohols, (PMNs P-96–554/555/556/557/558/559) are reaction products with maleic anhy- subject to reporting under this section dride (PMNs P-96–399/400/401/402/403/404) for the significant new uses described are subject to reporting under this sec- in paragraph (a)(1)(i) of this section. tion for the significant new uses de- (2) The significant new uses are: scribed in paragraph (a)(2) of this sec- (i) Industrial, commercial and consumer tion. activities. Requirements as specified in § 721.80(g). (2) The significant new uses are: (ii) [Reserved] (i) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(1), (b)(1), and sions of subpart A of this part apply to (c)(1). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), and (i) are applicable to manu- paragraph. facturers, importers, and processors of (1) Recordkeeping. Recordkeeping re- these substances. quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), and (k) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. these substances.

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(2) Limitations or revocation of certain Silvershield (at least 3 mils thick). As notification requirements. The provisions an alternative to the respiratory re- of § 721.185 apply to this section. quirements listed here, a manufac- [63 FR 3434, Jan. 22, 1998] turer, importer, or processor may choose to follow the NCEL provisions § 721.6479 Tetrahydroheteropolycycle listed in the TSCA section 5(e) consent (generic). order for this substance. The NCEL is (a) Chemical substance and significant 1.0 ug/m3 as an 8-hour time weighted new uses subject to reporting. (1) The average verified by actual monitoring chemical substance identified generi- data. cally as Tetrahydroheteropolycycle (ii) Hazard communication program. (PMN P-97–0766) is subject to reporting Requirements as specified in § 721.72 (a), under this section for the significant (b), (c), (d), (e) (concentration set at 0.1 new use described in paragraph (a)(2) of percent), (f), (g)(1)(i), (g)(1)(vii), this section. (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (2) The significant new uses are: (g)(2)(v), and (g)(5). (i) Protection in the workplace. Re- (iii) Industrial, commercial, and con- quirements as specified in § 721.63 sumer activities. Requirements as speci- (a)(1)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) fied in § 721.80(p) (12,300 kilograms). (if no data on cartridge service life (b) Specific requirements. The provi- testing has been reviewed and approved sions of subpart A of this part apply to by EPA), (a)(5)(xii) (if data on cartridge this section except as modified by this service life testing has been reviewed paragraph. and approved by EPA), (a)(5)(xiii), (1) Recordkeeping. Recordkeeping re- (a)(5)(xiv), (a)(6)(i), (a)(6)(ii) (a)(6)(iii), quirements as specified in § 721.125 (a), (a)(6)(iv), (a)(6)(v), and (a)(6)(vi), (b) (b), (c), (d), (e), (f), (g), (h), and (i) are (concentration set at 1.0 percent), and applicable to manufacturers, import- (c). The imperviousness of each item ers, and processors of this substance. pursuant to paragraph (a)(2)(i) must be demonstrated by actual testing under (2) Limitations or revocation of certain paragraph (a)(3) and not by manufac- notification requirements. The provisions turer specifications. Permeation test- of § 721.185 apply to this section. ing shall be conducted according to the [65 FR 81402, Dec. 26, 2000] American Society for Testing Mate- rials (ASTM) F739 ‘‘Standard Test § 721.6485 Hydroxy terminated poly- Method for Resistance of Protective ester. Clothing Materials to Permeation by (a) Chemical substance and significant Liquids or Gases.’’ Results shall be renew uses subject to reporting. (1) The corded as a cumulative permeation chemical substance identified generi- rate as a function of time, and shall be cally as a hydroxy terminated poly- documented in accordance with ASTM ester (PMN P-95–1213) is subject to re- F739 using the format specified in porting under this section for the sig- ASTM 1194–89 ‘‘Guide for Documenting nificant new uses described in para- the Results of Chemical Permeation graph (a)(2) of this section. Testing on Protective Clothing Mate- rials.’’ Gloves may not be used for a (2) The significant new uses are: time period longer than they are actu- (i) Release to water. Requirements as ally tested and must be replaced at the specified in § 721.90 (a)(1), (b)(1), and end of each work shift. The manufac- (c)(1). turer, importer, or processor must sub- (ii) [Reserved] mit all test data to the Agency and (b) Specific requirements. The provi- must receive written Agency approval sions of subpart A of this part apply to for each type of glove tested prior to this section except as modified by this use of such gloves. The following gloves paragraph. have been tested in accordance with (1) Recordkeeping. Recordkeeping re- the ASTM F739 method and found to quirements specified in § 721.125 (a), (b), satisfy the requirements for use by (c), and (k) are applicable to manufac- EPA: Latex (at least 14 mils thick), turers, importers, and processors of Nitrile (at least 16 mils thick), and this substance.

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§ 721.6490 Alkyl phenyl § 721.6495 Aliphatic polyisocyanate. polyetheramines. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substances identified generically as an aliphatic polyisocyanate cally as alkyl phenyl polyetheramines (PMN P-95–1347) is subject to reporting (PMNs P-95–1650/1651/1652/1653) are sub- under this section for the significant ject to reporting under this section for new uses described in paragraph (a)(2) the significant new uses described in of this section. paragraph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial, and con- (i) Release to water. Requirements as sumer activities. Requirements as speci- specified in § 721.90 (a)(1), (b)(1), and fied in § 721.80(y)(1). (c)(1). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [63 FR 3434, Jan. 22, 1998] [63 FR 3434, Jan. 22, 1998] § 721.6498 Modified polyisocyanates § 721.6493 Amidoamine modified poly- (generic). ethylene glycol (generic). (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified generically as modified polyisocyanates cally as an amidoamine modified poly- (PMN P-96–1428) is subject to reporting ethylene glycol (PMN P-99–0645) is sub- under this section for the significant ject to reporting under this section for new uses described in paragraph (a)(2) the significant new use described in of this section. paragraph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Protection in the workplace. Re- (i) Release to water. Requirements as quirements as specified in § 721.63 (a)(1), specified in § 721.90 (a)(1), (b)(1), and (a)(3), (a)(4), (a)(5)(ii), (a)(5)(viii), (c)(1). (a)(5)(ix), (a)(6)(ii), (b) (concentration (ii) [Reserved] set at 0.1 percent), and (c). As an alter- (b) Specific requirements. The provi- native to the respiratory requirements sions of subpart A of this part apply to listed here, a manufacturer, importer, this section except as modified by this or processor may choose to follow the paragraph. NCEL provisions listed in the TSCA (1) Recordkeeping. Recordkeeping re- section 5(e) consent order for this sub- quirements as specified in § 721.125 (a), stance. The NCEL is 0.05 mg/m3. (b), (c), and (k) are applicable to manu- (ii) Hazard communication program. facturers, importers, and processors of Requirements as specified in § 721.72 (a), this substance. (b), (c), (d), (e) (concentration set at 0.1

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percent), (f), and (g)(5). The following spill prevention and cleanup practices; statements shall appear on each label and, if feasible, means to measure air- as specified in § 721.72(b) and the MSDS borne levels of polyisocyanates and as specified in § 721.72(c): Warnings. Ex- diisocyanates. During spray applica- posure to diisocyanates may cause the tions, workers should take precautions following human health effects: Skin to avoid breathing vapors, mists or irritation and allergic reactions, res- aerosols. Inhalation exposures should piratory irritation, respiratory sen- be limited to < 0.05 mg/m3 as an 8-hour sitization, and lung toxicity; some time-weighted average (TWA) for com- diisocyanates also may cause cancer. bined polyisocyanates and The likelihood that these effects will diisocyanates. Engineering controls occur depends on a number of factors; should serve as the first, most effective among them, the level of exposure, fre- means of reducing airborne quency of exposure, part of the body polyisocyanate and diisocyanate con- exposed, and sensitivity of the exposed centrations; an appropriate National individual. Symptoms of allergic reac- Institute for Occupational Safety and tion and respiratory sensitization in- Health/Mine Safety and Health Admin- clude rashes, cough, shortness of istration (NIOSH/MSHA) approved res- breath, asthma, chest tightness and pirator should be used as a secondary other breathing difficulties. There is tool to lower exposures. Currently, uncertainty as to the mechanism by downdraft spray booths and high-vol- which sensitization occurs. In sen- ume low-pressure (HVLP) spray guns sitized individuals, exposure to even appear to offer the most efficient tech- small amounts of diisocyanates (below nology to reduce inhalation exposures; government-recommended workplace a maintenance program should always exposure levels) may cause allergic res- be used to ensure optimal operating ef- piratory reactions like asthma and se- ficiencies. To limit dermal contact, in- vere breathing difficulties. It is espe- dividuals should wear impermeable cially important to note that contact gloves, protective clothing and goggles with skin may lead to respiratory sen- or glasses with side shields. sitization or cause other allergic reac- (iii) Industrial, commercial, and con- tions. In some cases, the effects of sumer activites. Requirements as speci- diisocyanate exposure may be imme- fied in § 721.80(q). diate and life-threatening; in others, (b) Specific requirements. The provi- the effects may be delayed and occur sions of subpart A of this part apply to hours after the exposure has ended. Re- this section except as modified by this peated or prolonged exposure to paragraph. diisocyanates may also cause irritation (1) Recordkeeping. Recordkeeping re- to eyes, skin, respiratory tract and quirements as specified in § 721.125 (a), lungs, as well as adverse chronic lung (b), (c), (d), (e), (f), (g), (h), and (i) are effects, like decreased lung capacity applicable to manufacturers, import- and function. Individuals experiencing ers, and processors of this substance. shortness of breath, tightness in the (2) Limitations or revocation of certain chest or other problems breathing notification requirements. The provisions should seek immediate medical atten- of § 721.185 apply to this section. tion. When using this substance the (3) Determining whether a specific use is following protective measures should subject to this section. The provisions of be used: In workplaces where individ- § 721.1725(b)(1) apply to this section. uals handle diisocyanates or coatings or other formulations that contain [63 FR 44580, Aug. 20, 1998] them, an industrial hygiene and safety program should be operative. Impor- § 721.6505 Polymers of C13C15 tant components of this program in- oxoalcohol ethoxolates. clude: Hazard communication and (a) Chemical substance and significant training on safe handling practices; use new uses subject to reporting. (1) The of efficient and well-maintained appli- chemical substances identified generi- cation equipment, engineering controls cally as polymers of C13C15 oxoalcohol and personal protective equipment; ethoxolates (PMNs P-96–950/951) are housekeeping procedures including subject to reporting under this section

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for the significant new uses described cally as acrylamide, polymer with sub- in paragraph (a)(2) of this section. stituted alkylacrylamide salt (PMN P- (2) The significant new uses are: 87–794) is subject to reporting under (i) Release to water. Requirements as this section for the significant new specified in § 721.90 (a)(1), (b)(1), and uses described in paragraph (a)(2) of (c)(1). this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Requirements as speci- this section except as modified by this fied in § 721.80(p) (limit set at 216,700 paragraph. kg). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), and (k) are applicable to manu- sions of subpart A of this part apply to facturers, importers, and processors of this section except as modified by this these substances. (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. The following rec- of § 721.185 apply to this section. ordkeeping requirements are applicable to manufacturers, importers, and proc- [63 FR 3434, Jan. 22, 1998] essors of this substance: Recordkeeping requirements specified in § 721.125 (a), § 721.6515 Polymerof polyalkylenepolyol and (b), (c), and (i). trisubstituted phenol (generic). (2) Limitations or revocation of certain notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The chemical substance identified generi- [55 FR 33303, Aug. 15, 1990. Redesignated at 55 cally as polymer of polyalkylenepolyol FR 52276, Dec. 21, 1990. Further redesignated and trisubstituted phenol (PMN P-98– at 58 FR 29946, May 24, 1993, as amended at 58 1016) is subject to reporting under this FR 34204, June 23, 1993] section for the significant new use described in paragraph (a)(2) of this sec- § 721.6540 Acrylamide, polymers with tion. tetraalkyl ammonium salt and polyalkyl, aminoalkyl methacryla- (2) The significant new uses are: mide salt. (i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (a) Chemical substances and significant (c)(4) (N=10 ppb). new uses subject to reporting. (1) The (ii) [Reserved] chemical substances identified generi- (b) Specific requirements. The provi- cally as acrylamide, polymers with sions of subpart A of this part apply to tetraalkyl ammonium salt and polyal- this section except as modified by this kyl, amino alkyl methacrylamide salt paragraph. (PMNs P-88–2100 and P-88–2169) are sub- (1) Recordkeeping. Recordkeeping reject to reporting under this section for quirements as specified in § 721.125 (a), the significant new use described in (b), (c), and (k) are applicable to manu- paragraph (a)(2) of this section. facturers, importers, and processors of (2) The significant new use is: this substance. (i) Release to water. Requirements as (2) Limitations or revocation of cer- specified in § 721.90 (a)(1), (b)(1), and tain notification requirements. The (c)(1). provisions of § 721.185 apply to this sec- (ii) [Reserved] tion. (b) Specific requirements. The provi- [65 FR 81403, Dec. 26, 2000] sions of subpart A of this part apply to this section except as modified by this § 721.6520 Acrylamide, polymer with paragraph. substituted alkylacrylamide salt (1) Recordkeeping requirements. Re- (generic name). quirements as specified in § 721.125 (a), (a) Chemical substances and significant (b), (c), and (k) are applicable to manu- new uses subject to reporting. (1) The facturers, importers, and processors of chemical substance identified generi- this substance.

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(2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this [57 FR 46468, Oct. 8, 1992, as amended at 58 FR paragraph. 34204, June 23, 1993] (1) Recordkeeping requirements. Re- quirements as specified in § 721.125 (a), § 721.6560 Acrylic acid, polymer with (b), (c), (i), and (j) are applicable to substituted ethene. manufacturers, importers, and proc- (a) Chemical substance and significant essors of this substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified generi- notification requirements. The provisions cally as acrylic acid, polymer with sub- of § 721.185 apply to this section. stituted ethene (PMN P-91–521) is sub- (3) Determining whether a specific use is ject to reporting under this section for subject to this section. The provisions of the significant new uses described in § 721.1725(b)(1) apply to this section. paragraph (a)(2) of this section. (2) The significant new uses are: [57 FR 44070, Sept. 23, 1992, as amended at 58 (i) Release to water. Requirements as FR 29946, May 24, 1993; 58 FR 34204, June 23, specified in § 721.90 (a)(4), (b)(4), and 1993] (c)(4) (N = 200 ppb). (ii) [Reserved] § 721.6660 Polymer of alkanepolyol and polyalkylpolyisocyanatocarbo- (b) Specific requirements. The provi- monocycle, acetone oxime-blocked sions of subpart A of this part apply to (generic name). this section except as modified by this paragraph. (a) Chemical substance and significant (1) Recordkeeping requirements. Re- new uses subject to reporting. (1) The quirements as specified in § 721.125 (a), chemical substance identified generi- (b), (c), and (k) are applicable to manu- cally as a polymer of alkanepolyol and facturers, importers, and processors of polyalkylpolyisocyanatocarbomonocy- this substance. cle, acetone oxime-blocked (PMN P-88– (2) Limitations or revocation of certain 1658) is subject to reporting under this notification requirements. The provisions section for the significant new uses de- of § 721.185 apply to this section. scribed in paragraph (a)(2) of this section. [57 FR 46468, Oct. 8, 1992, as amended at 53 FR 34204, June 23, 1993] (2) The significant new uses are: (i) Industrial, commercial, and con- § 721.6620 Alkanaminium, polyalkyl- sumer activities. Requirements as speci- [(2-methyl-1-oxo-2-propenyl)oxy] fied in § 721.80(q). salt, polymer with acrylamide and (ii) [Reserved] substituted alkyl methacrylate. (b) Specific requirements. The provi- (a) Chemical substance and significant sions of subpart A of this part apply to new uses subject to reporting. (1) The this section except as modified by this chemical substance identified generi- paragraph. cally as alkanaminium, polyalkyl-[(2- (1) Recordkeeping. The following rec- methyl-1-oxo-2-propenyl)oxy] salt, ordkeeping requirements are applicable polymer with acrylamide and sub- to manufacturers, importers, and proc- stituted alkyl methacrylate (PMN P- essors of this substance, as specified in 87–252) is subject to reporting under § 721.125 (a), (b), (c), and (i). this section for the significant new (2) Limitations or revocation of certain uses described in paragraph (a)(2) of notification requirements. The provisions this section. of § 721.185 apply to this significant new (2) The significant new uses are: use rule. (i) Industrial, commercial, and consumer activities. Requirements as speci- (3) Determining whether a specific use is fied in § 721.80(p) (production limit set subject to this section. The provisions of at 680,000 kg). § 721.1725(b)(1) apply to this section. (ii) Release to water. Requirements as [55 FR 26100, June 26, 1990. Redesignated and specified in § 721.85 (a)(4), (b)(4) and amended at 58 FR 29946, 29947, May 24, 1993; 58 (c)(4) (concentration set at 40 ppb). FR 34204, June 23, 1993]

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§ 721.6680 Alkanoic acid, butanediol of § 721.185 apply to this significant new and cyclohexanealkanol polymer use rule. (generic name). (3) Determining whether a specific use is (a) Chemical substance and significant subject to this section. The provisions of new uses subject to reporting. (1) The § 721.1725(b)(1) apply to this section. chemical substance alkanoic acid, butanediol, and cyclohexanealkanol [55 FR 32417, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, 29947, May 24, 1993; 58 polymer (PMN P-89–672) is subject to FR 34204, June 23, 1993] reporting under this section for the significant new uses described in para- § 721.6900 Polymer of bisphenol A di- graph (a)(2) of this section. glycidal ether, substituted alkenes, (2) The significant new uses are: and butadiene. (i) Hazard communication program. A significant new use of this substance is (a) Chemical substances and significant any manner or method of manufacture, new uses subject to reporting. (1) The import, or processing associated with chemical substances identified generi- any use of this substance without pro- cally as polymer of bisphenol A viding risk notification as follows. diglycidal ether, substituted alkenes, (A) If as a result of the test data re- and butadiene (PMNs P-90–244 and P- quired under the section 5(e) consent 90–245) are subject to reporting under order for this substance, the employer this section for the significant new becomes aware that this substance uses described in paragraph (a)(2) of may present a risk of injury to human this section. health, the employer must incorporate (2) The significant new uses are: this new information, and any informa- (i) Protection in the workplace. Re- tion on methods for protecting against quirements as specified in § 721.63 (a)(1), such risk, into a Material Safety Data (a)(3), (a)(6)(ii), (b) (concentration set Sheet (MSDS) as described in § 721.72(c) at 0.1 percent), and (c). within 90 days from the time the em- (ii) Hazard communication program. ployer becomes aware of the new infor- Requirements as specified in § 721.72 (a), mation. If this substance is not being (b), (c), (d), (e) (concentration set at 0.1 manufactured, imported, processed, or used in the employer’s workplace, the percent), (f), (g)(1)(vi), (g)(1)(vii), employer must add the new informa- (g)(2)(v), and (g)(5). tion to an MSDS before the substance (iii) Industrial, commercial, and con- is reintroduced into the workplace. sumer activities. Requirements as speci- (B) The employer must ensure that fied in § 721.80(q). persons who have received, or will re- (b) Specific requirements. The provi- ceive, this substance from the em- sions of subpart A of this part apply to ployer are provided an MSDS as de- this section except as modified by this scribed in § 721.72(c) containing the in- paragraph. formation required under paragraph (1) Recordkeeping requirements. The (a)(2)(i)(A) within 90 days from the following recordkeeping requirements time the employer becomes aware of are applicable to manufacturers, im- the new information. porters, and processors of this sub- (ii) Industrial, commercial, and con- stance, as specified in § 721.125 (a) sumer activities. Requirements as speci- through (i). fied in § 721.80(q) (293,000 kg). (2) Limitations or revocation of certain (b) Specific requirements. The provi- The provisions sions of subpart A of this part apply to notification requirements. this section except as modified by this of § 721.185 apply to this significant new paragraph. use rule. (1) Recordkeeping. The following rec- (3) Determining whether a specific use is ordkeeping requirements are applicable subject to this section. The provisions of to manufacturers, importers, and proc- § 721.1725(b)(1) apply to this section. essors of this substance, as specified in [56 FR 15791, Apr. 17, 1991. Redesignated and § 721.125 (a) through (c), (h) and (i). amended at 58 FR 29946, May 24, 1993; 58 FR (2) Limitations or revocation of certain 34204, June 23, 1993] notification requirements. The provisions

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§ 721.6920 Butyl acrylate, polymer new uses described in paragraph (a)(2) with substituted methyl styrene, of this section. methyl methacrylate, and sub- (2) The significant new uses are: stituted silane. (i) Protection in the workplace. Re- (a) Chemical substance and significant quirements as specified in § 721.63 (a)(1) new uses subject to reporting. (1) The and (a)(3), (b) [concentration set at 0.1 chemical substance identified as butyl percent], and (c). acrylate, polymer with substituted (ii) Hazard communication program. methyl styrene, methyl methacrylate, Requirements as specified in § 721.72 and substituted silane (PMN P-91–272) (b)(2), (c), (d), (e) [concentration set at is subject to reporting under this sec- 0.1 percent], (f), and (g)(1)(vi) and tion for the significant new uses de- (g)(1)(vii), (g)(2)(i) and (g)(2)(v), (g)(4)(i), scribed in paragraph (a)(2) of this sec- and (g)(5). The provision of § 721.72(d) tion. requiring that employees be provided (2) The significant new uses are: with information on the location and (i) Protection in the workplace. Re- availability of MSDSs does not apply quirements as specified in § 721.63 (a)(1), when a MSDS was not required under (a)(2)(iii), (a)(3), (a)(4), (a)(5)(ii), § 721.72(c). (a)(5)(viii), (a)(5)(ix), (a)(6)(ii), (b) (con- (iii) Industrial, commercial, and concentration set at 1.0 percent), and (c). sumer activities. Requirements as speci- (ii) Hazard communication program. fied in § 721.80 (k) and (y). Requirements as specified in § 721.72 (a), (iv) Disposal. Requirements as speci- (b), (c), (d), (e) (concentration set at 1.0 fied in § 721.85 (a)(1) and (a)(2) and (b)(1) per cent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), and (b)(2). (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (b) Specific requirements. The provi- and (g)(5). sions of subpart A of this part apply to (iii) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80(p) (volume set at 90,000 (1) Recordkeeping. The following rec- kg), (volume set at 512,000 kg), (volume ordkeeping requirements are applicable set at 1,235,000 kg). to manufacturers, importers, and proc- (b) Specific requirements. The provi- essors of this substance, as specified in sions of subpart A of this part apply to § 721.125 (a) through (i). this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping requirements. Re- of § 721.185 apply to this significant new quirements as specified in § 721.125 (a) use rule. through (i) are applicable to manufac- (3) Determining whether a specific use is turers, importers, and processors of subject to this section. The provisions of this substance. § 721.1725(b)(1) apply to this section. (2) Limitations or revocation of certain [55 FR 26109, June 26, 1990. Redesignated and notification requirements. The provisions amended at 58 FR 29946, May 24, 1993; 58 FR of § 721.185 apply to this section. 34204, June 23, 1993]

[57 FR 44070, Sept. 23, 1992, as amended at 58 § 721.7000 Polymer of disodium male- FR 34204, June 23, 1993] ate, allyl ether, and ethylene oxide. § 721.6980 Dimer acids, polymer with (a) Chemical substance and significant polyalkylene glycol, bisphenol A- new uses subject to reporting. (1) The diglycidyl ether, and alky- chemical substance identified generi- lenepolyols polyglycidyl ethers (ge- cally as a polymer of disodium male- neric name). ate, allyl ether, and ethylene oxide (P- (a) Chemical substance and significant 91–1086) is subject to reporting under new uses subject to reporting. (1) The this section for the significant new chemical substance dimer acids, poly- uses described in paragraph (a)(2) of mer with polyalkylene glycol, this section. bisphenol A-diglycidyl ether, and (2) The significant new uses are: alkylenepolyols polyglycidyl ethers (i) Hazard communication program. A (PMN P-86–628) is subject to reporting significant new use of this substance is under this section for the significant any manner or method of manufacture,

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import, or processing associated with leum), C(3-6), polymers with styrene any use of this substance without pro- and mixed terpenes (PMN P-89–676) is viding risk notification as follows: subject to reporting under this section (A) If as a result of the test data re- for the significant new uses described quired under the section 5(e) consent in paragraph (a)(2) of this section. order for this substance, the employer (2) The significant new uses are: becomes aware that this substance (i) Hazard communication program. A may present a risk of injury to human significant new use of this substance is health, the employer must incorporate any manner or method of manufacture, this new information, and any informa- import, or processing associated with tion on methods for protecting against any use of this substance without pro- such risk, into an MSDS as described in § 721.72(c) within 90 days from the viding risk notification as follows. time the employer becomes aware of (A) If as a result of the test data re- the new information. If this substance quired under the section 5(e) consent is not being manufactured, imported, order for this substance, the employer processed, or used in the employer’s becomes aware that this substance workplace, the employer must add the may present a risk of injury to human new information to an MSDS before health, the employer must incorporate the substance is reintroduced into the this new information, and any informa- workplace. tion on methods for protecting against (B) The employer must ensure that such risk, into a Material Safety Data persons who have received, or will re- Sheet (MSDS) as described in § 721.72(c) ceive, this substance from the em- within 90 days from the time the employer are provided an MSDS as de- ployer becomes aware of the new infor- scribed in § 721.72(c) containing the in- mation. If this substance is not being formation required under paragraph manufactured, imported, processed, or (a)(2)(i)(A) of this section within 90 used in the employer’s workplace, the days from the time the employer be- employer must add the new informa- comes aware of the new information. tion to an MSDS before the substance (ii) Industrial, commercial, and con- is reintroduced into the workplace. sumer activities. Requirements as speci- (B) The employer must ensure that fied in § 721.80(q). (b) Specific requirements. The provi- persons who have received, or will re- sions of subpart A of this part apply to ceive, this substance from the em- this section except as modified by this ployer are provided an MSDS as de- paragraph. scribed in § 721.72(c) containing the in- (1) Recordkeeping requirements. The formation required under paragraph following recordkeeping requirements (a)(2)(i)(A) within 90 days from the are applicable to manufacturers, im- time the employer becomes aware of porters, and processors of this sub- the new information. stance, as specified in § 721.125 (a), (h), (ii) Industrial, commercial, and con- and (i). sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(q). notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to (3) Determining whether a specific use is this section except as modified by this subject to this section. The provisions of paragraph. § 721.1725(b)(1) apply to this section. (1) Recordkeeping. The following rec- [57 FR 44071, Sept. 23, 1992, as amended at 58 ordkeeping requirements are applicable FR 29946, May 24, 1993; 58 FR 34204, June 23, to manufacturers, importers, and proc- 1993] essors of this substance, as specified in § 721.7020 Distillates (petroleum), C(3- § 721.125 (a) through (c), (h) and (i). 6), polymers with styrene and (2) Limitations or revocation of certain mixed terpenes (generic name). notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this significant new new uses subject to reporting. (1) The use rule. chemical substance distillates (petro-

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(3) Determining whether a specific use is (2) Limitations or revocation of certain subject to this section. The provisions of notification requirements. The provisions § 721.1725(b)(1) apply to this section. of § 721.185 apply to this section. [55 FR 32414, Aug. 9, 1990. Redesignated and (3) Determining whether a specific use is amended at 58 FR 29946, May 24, 1993; 58 FR subject to this section. The provisions of 34204, June 23, 1993] § 721.1725(b)(1) apply to this section. [60 FR 45084, Aug. 30, 1995, as amended at 62 § 721.7046 Formaldehyde, polymer FR 42692, Aug. 8, 1997] with substituted phenols, glycidyl ether. § 721.7160 2-Oxepanone, polymer with (a) Chemical substance and significant 4,4′-(1-methylethylidene)bisphenol new uses subject to reporting. (1) The and 2,2-[(1-methylethylidene)bis(4,1- chemical substance identified as form- phenyleneoxymethylene)]bisoxi- aldehyde, polymer with substituted rane, graft. phenols, glycidyl ether (PMN P-93–955) (a) Chemical substance and significant is subject to reporting under this sec- new uses subject to reporting. (1) The tion for the significant new uses de- chemical substance 2-oxepanone, poly- scribed in paragraph (a)(2) of this sec- mer with 4,4′(1-methylethyli- tion. The requirements of this section dene)bisphenol and 2,2-[(1-methyleth- do not apply once the substance is a ylidene) bis(4,1-phenyleneoxymeth- component of a highly densified tablet ylene)]bisoxirane, graft (PMN P-88– formulation of an epoxy molding com- 2582) is subject to reporting under this pound. section for the significant new uses de- (2) The significant new uses are: scribed in paragraph (a)(2) of this sec- (i) Protection in the workplace. Re- tion. quirements as specified in § 721.63 (a)(1), (2) The significant new uses are: (a)(3), (a)(4), (a)(6)(i), (b) (concentration (i) Protection in the workplace. Re- set at 0.1 percent), and (c). Require- quirements as specified in § 721.63 (a)(1), ments as specified in § 721.63 (a)(5)(i) (a)(3), (a)(4), (a)(5)(i),(a)(5)(ii), (a)(5)(iii), apply during manufacturing only. Re- (a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(5)(xi), quirements as specified in (a)(6)(ii), (b) (concentration set at 0.1 § 721.63(a)(5)(i) through (a)(5)(vii) apply percent), and (c). during processing for workers exposed (ii) Hazard communication program. greater than 17 days per year or during Requirements as specified in § 721.72 (a), use. (b), (c), (d), (e) (concentration set at 0.1 (ii) Hazard communication program. percent), (f), (g)(1)(iv), (g)(1)(vi), Requirements as specified in § 721.72 (a), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(iv), (g)(1)(vi), (g)(2)(iv), (g)(2)(v), and (g)(5). (g)(1)(vii), (g)(2)(i) through (g)(2)(v), (iii) Industrial, commercial, and con- (g)(3)(i), (g)(3)(ii), (g)(4)(i), (g)(4)(iii), sumer activities. Requirements as speci- and (g)(5). fied in § 721.80 (l) and (q). (iii) Industrial, commercial, and con- (b) Specific requirements. The provi- sumer activities. Requirements as speci- sions of subpart A of this part apply to fied in § 721.80 (b), (l), and (q). this section except as modified by this (iv) Release to water. Requirements as paragraph. specified in § 721.90 (a)(1), (b)(1), and (1) Recordkeeping. The following rec- (c)(1). ordkeeping requirements are applicable (b) Specific requirements. The provi- to manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance, as specified in this section except as modified by this § 721.125 (a) through (i). paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a) of § 721.185 apply to this significant new through (i) and (k) are applicable to use rule. manufacturers, importers, and processors of this substance.

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(3) Determining whether a specific use is subject to reporting under this section subject to this section. The provisions of for the significant new uses described § 721.1725(b)(1) apply to this section. in paragraph (a)(2) of this section. The [55 FR 33306, Aug. 15, 1990. Redesignated and requirements of this section do not amended at 58 FR 29946, 29947, May 24, 1993; 58 apply once the substance is a compo- FR 34204, June 23, 1993] nent of a highly densified tablet formulation of an epoxy molding compound. § 721.7200 Perfluoroalkyl aromatic car- (2) The significant new uses are: bamate modified alkyl methacrylate (i) Protection in the workplace. Re- copolymer. quirements as specified in § 721.63 (a)(1), (a) Chemical substance and significant (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), (a)(6)(i), new uses subject to reporting. (1) The (b) (concentration set at 0.1 percent), chemical substance identified generi- and (c). cally as perfluoroalkyl aromatic carba- (ii) Hazard communication program. mate modified alkyl methacrylate co- Requirements as specified in § 721.72 (a) polymer (PMN P-87–1555) is subject to through (e) (concentration set at 0.1 reporting under this section for the sig- percent), (f), (g)(1)(vi), (g)(1)(vii), nificant new uses described in para- (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), graph (a)(2) of this section. (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), (2) The significant new uses are: and (g)(5). (i) Hazard communication program. Re- (iii) Industrial, commercial, and con- quirements asspecified in § 721.72 (a), sumer activities. Requirements as speci- (b), (c), (d), (e) (concentration set at 0.1 fied in § 721.80(q). percent for cancer; 1.0 percent for other (iv) Release to water. Requirements as effects), (f), (g)(1)(ii), (g)(2)(ii), and specified in § 721.90 (a)(1), (b)(1), and (g)(5). In addition, the following human (c)(1). health hazard statement shall appear (b) Specific requirements. The provi- on each label and MSDS required by sions of subpart A of this part apply to this section: This substance may cause this section except as modified by this lung effects. paragraph. (ii) Industrial, commercial, and con- (1) Recordkeeping requirements. Re- sumer activities. Requirements as speci- quirements as specified in § 721.125 (a) fied in § 721.80 (o) and (q). through (i), and (k) are applicable to (b) Specific requirements. The provi- manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping requirements. Re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), (3) Determining whether a specific use is (b), (c), and (f) through (i) are applica- subject to this section. The provisions of ble to manufacturers, importers, and § 721.1725(b)(1) apply to this section. processors of this substance. [57 FR 44071, Sept. 23, 1992, as amended at 58 (2) Limitations or revocation of certain FR 29946, May 24, 1993; 58 FR 34204, June 23, notification requirements. The provisions 1993; 62 FR 42692, Aug. 8, 1997] of § 721.185 apply to this section. (3) Determining whether a specific use is § 721.7220 Polymer of substituted phe- subject to this section. The provisions of nol, formaldehyde, epichlorohydrin, § 721.1725(b)(1) apply to this section. and disubstituted benzene. [57 FR 44071, Sept. 23, 1992, as amended at 58 (a) Chemical substance and significant FR 29946, May 24, 1993; 58 FR 34204, June 23, new uses subject to reporting. (1) The 1993] chemical substance identified generically as polymer of substituted phenol, § 721.7210 Epoxidized copolymer of formaldehyde, epichlorohydrin, and phenol and substituted phenol. disubstituted benzene (PMN P-89–1104) (a) Chemical substance and significant is subject to reporting under this sec- new uses subject to reporting. (1) The tion for the significant new uses de- chemical substance identified as scribed in paragraph (a)(2) of this sec- epoxidized copolymer of phenol and tion. substituted phenol (PMN P-91–598) is (2) The significant new uses are:

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(i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 (a)(1), paragraph. (a)(3), (b) (concentration set at 0.1 per- (1) Recordkeeping. Recordkeeping recent), and (c). quirements as specified in § 721.125(a), (ii) Hazard communication program. (b), (c), and (i) are applicable to manu- Requirements as specified in § 721.72 (a), facturers, importers, and processors of (b), (c), (d), (e) (concentration set at 0.1 this chemical substance. percent), (f), (g)(1)(vi), (g)(1)(vii), (2) Limitations or revocation of certain (g)(2)(i), (g)(2)(v), (g)(4)(i), and (g)(5). notification requirements. The provisions The following additional human hazard of § 721.185 apply to this section. precautionary statement shall appear (3) Determining whether a specific use is on each label as specified in § 721.72(b): subject to this section. The provisions of Disposal restrictions apply. § 721.575(b)(1) apply to this section. (iii) Industrial, commercial, and con- [68 FR 70180, Dec. 17, 2003] sumer activities. Requirements as specified in § 721.80(q). § 721.7255 Polyethyleneamine (iv) Disposal. Requirements as speci- crosslinked with substituted poly- fied in § 721.85 (a)(1), (b)(1), and (c)(1). ethylene glycol (generic). (v) Release to water. Requirements as (a) Chemical substance and significant specified in § 721.90(c)(2)(v), or diatoma- new uses subject to reporting. (1) The ceous earth filtration. chemical substance identified generi- (b) Specific requirements. The provi- cally as polyethyleneamine crosslinked sions of subpart A of this part apply to with substituted polyethylene glycol this section except as modified by this with substituted polyethylene glycol paragraph. (PMN P-01–833) is subject to reporting (1) Recordkeeping. The following rec- under this section for the significant ordkeeping requirements are applicable new use described in paragraph (a)(2) of to manufacturers, importers, and proc- this section. essors of this substance: § 721.125 (a) (2) The significant new uses are: through (k). (i) Industrial, commercial, and consumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(j) (absorbent polymer). notification requirements. The provisions (ii) [Reserved] of § 721.185 apply to this significant new (b) Specific requirements. The provi- use rule. sions of subpart A of this part apply to (3) Determining whether a specific use is this section except as modified by this subject to this section. The provisions of paragraph. § 721.1725(b)(1) apply to this section. (1) Recordkeeping. Recordkeeping re- [56 FR 19242, Apr. 25, 1991. Redesignated and quirements as specified in § 721.125(a), amended at 58 FR 29946, 29947, May 24, 1993; 58 (b), (c), and (i) are applicable to manu- FR 34204, June 23, 1993] facturers, importers, and processors of this chemical substance. § 721.7250 Polyaziridinyl ester of an al- (2) Limitations or revocation of certain iphatic alcohol (generic). notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The [68 FR 70180, Dec. 17, 2003] chemical substance identified generically as a polyaziridinyl ester of an ali- § 721.7260 Polymer of polyethylene- phatic alcohol (PMN P-01–97) is subject polyamine and alkanediol digly- to reporting under this section for the cidyl ether. significant new use described in para- (a) Chemical substance and significant graph (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified generi- (i) Industrial, commercial, and con- cally as polymer of sumer activities. Requirements as speci- polyethylenepolyamine and alkanediol fied in § 721.80(j). diglycidyl ether (PMN P-89–810) is sub- (ii) [Reserved] ject to reporting under this section for (b) Specific requirements. The provi- the significant new uses described in sions of subpart A of this part apply to paragraph (a)(2) of this section.

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(2) The significant new uses are: of § 721.185 apply to this significant new (i) Hazard communication program. A use rule. significant new use of this substance is [55 FR 46774, Nov. 6, 1990. Redesignated at 58 any manner or method of manufacture, FR 29947, May 24, 1993, as amended at 58 FR import, or processing associated with 34204, June 23, 1993] any use of this substance without providing risk notification as follows. § 721.7270 1-propanaminium, 3-amino-, N,N,N-trimethyl-N-soya acyl derivs., (A) If as a result of the test data re- chloride. quired under the section 5(e) consent order for this substance, the employer (a) Chemical substance and significant becomes aware that this substance new uses subject to reporting. (1) The may present a risk of injury to human chemical substance identified as 1- propanaminium, 3-amino-, N,N,N- health or the environment, the em- trimethyl-N-soya acyl derivs., chloride ployer must incorporate this new infor- (PMN P-01–646; CAS No. 391232–99–8) is mation, and any information on meth- subject to reporting under this section ods for protecting against such risk, for the significant new use described in into a Material Safety Data Sheet paragraph (a)(2) of this section. (MSDS) which includes a written list- (2) The significant new uses are: ing of safety data for this substance (i) Industrial, commercial, and con- within 90 days from the time the em- sumer activities. Requirements as speci- ployer becomes aware of the new infor- fied in § 721.80(j). mation. If this substance is not being (ii) [Reserved] manufactured, imported, processed, or (b) Specific requirements. The provi- used in the employer’s workplace, the sions of subpart A of this part apply to employer must add the new informa- this section except as modified by this tion to an MSDS before the substance paragraph. is reintroduced into the workplace. (1) Recordkeeping. Recordkeeping re- (B) The employer must ensure that quirements as specified in § 721.125(a), persons who have received, or will re- (b), (c), and (i) are applicable to manu- ceive, this substance from the em- facturers, importers, and processors of ployer are provided an MSDS con- this chemical substance. taining a written listing of safety data (2) Limitations or revocation of certain for this chemical and the information notification requirements. The provisions required under paragraph (a)(2)(i)(A) of § 721.185 apply to this section. within 90 days from the time the em- (3) Determining whether a specific use is ployer becomes aware of the new infor- subject to this section. The provisions of mation. § 721.1725 apply to this section. (ii) Industrial, commercial, and con- [68 FR 70181, Dec. 17, 2003] sumer activities. Requirements as specified in § 721.80(p) (2,000,000 kg). § 721.7280 1,3-Propanediamine, N,N′- (b) Specific requirements. The provi- 1,2-ethanediylbis-, polymer with 2,4,6-trichloro-1,3,5-triazine, reac- sions of subpart A of this part apply to tion products with N-butyl-2,2,6,6- this section except as modified by this tetramethyl-4-piperidinamine. paragraph. (a) Chemical substance and significant (1) Recordkeeping. The following rec- new uses subject to reporting. (1) The ordkeeping requirements are applicable chemical substance identified as 1,3- to manufacturers, importers, and proc- propanediamine, N,N′-1,2-ethanediylbis- essors of this substance, as specified in , polymer with 2,4,6-trichloro-1,3,5-tri- § 721.125 (a), (c), and (h) (In addition, azine, reaction products with N-butyl- each manufacturer, importer and proc- 2,2,6,6-tetramethyl-4-piperidinamine essor of this substance shall maintain (PMN P-89–632) is subject to reporting for five years from the date of their under this section for the significant creation, copies of material safety data new uses described in paragraph (a)(2) sheets required under paragraph of this section. (a)(2)(i)(A) of this section). (2) The significant new uses are: (2) Limitations or revocation of certain (i) Protection in the workplace. Re- notification requirements. The provisions quirements as specified in § 721.63 (a)(1),

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(a)(2)(iii), (a)(3), (a)(4), (a)(5)(i), (2) Limitations or revocation of certain (a)(5)(ii), (a)(5)(iv), (a)(5)(v), (a)(6)(i), notification requirements. The provisions (a)(6)(ii), (b) (concentration set at 0.1 of § 721.185 apply to this section. percent), and (c). [63 FR 44581, Aug. 20, 1998] (ii) Hazard communication program. Requirements as specified in § 721.72 (a) § 721.7286 Amines, N- through (f), (g)(1)(iv), (g)(1)(viii), tallowalkyltripropylenetetra-, cit- (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), rates. (g)(2)(v), and (g)(5). (a) Chemical substances and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified as this section except as modified by this amines, N- paragraph. tallowalkyltripropylenetetra-, citrates (1) Recordkeeping. The following rec- (PMN P-93–881; CAS No. 189120–62–5) is ordkeeping requirements are applicable subject to reporting under this section to manufacturers, importers, and proc- for the significant new uses described essors of this substance, as specified in in paragraph (a)(2) of this section. § 721.125 (a) through (i). (2) The significant new uses are: (2) Limitations or revocation of certain (i) Hazard communication program. Re- notification requirements. The provisions quirements as specified in § 721.72 (a), of § 721.185 apply to this significant new (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), and use rule. (g)(5). (3) Determining whether a specific use is (ii) Release to water. Requirements as subject to this section. The provisions of specified in § 721.90 (a)(1), (b)(1), and § 721.1725(b)(1) apply to this section. (c)(1). (b) Specific requirements. The provi- [55 FR 33308, Aug. 15, 1990. Redesignated and sions of subpart A of this part apply to amended at 58 FR 29946, 29947, May 24, 1993; 58 this section except as modified by this FR 34204, June 23, 1993; 60 FR 65582, Dec. 20, paragraph. 1995] (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), § 721.7285 Amines, N- cocoalkyltrimethylenedi-, citrates. (b), (c), (f), (g), (h), and (k) are applicable to manufacturers, importers, and (a) Chemical substances and significant processors of this substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified as notification requirements. The provisions amines, N-cocoalkyltrimethylenedi-, of § 721.185 apply to this section. citrates. (PMN P-93–880; CAS No. 189120–63–6) is subject to reporting [63 FR 44581, Aug. 20, 1998] under this section for the significant § 721.7290 Propanoic acid, 2- new uses described in paragraph (a)(2) (trimethoxysilyl)-, ethyl ester. of this section. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Hazard communication program. Re- chemical substance identified as pro- quirements as specified in § 721.72 (a), panoic acid, 2-(trimethoxysilyl)-, ethyl (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), and ester (PMN P-01–22; CAS No. 137787–41– (g)(5). 8) is subject to reporting under this (ii) Release to water. Requirements as section for the significant new use de- specified in § 721.90 (a)(1), (b)(1), and scribed in paragraph (a)(2) of this sec- (c)(1). tion. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified § 721.90(a)(4), (b)(4), and (c)(4) paragraph. (N=10). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), (f), (g), (h), and (k) are applica- sions of subpart A of this part apply to ble to manufacturers, importers, and this section except as modified by this processors of this substance. paragraph.

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(1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125(a), paragraph. (b), (c), and (k) are applicable to manu- (1) Recordkeeping. Recordkeeping re- facturers, importers, and processors of quirements as specified in § 721.125 (a), this chemical substance. (b), (c), and (i) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain [68 FR 70181, Dec. 17, 2003] notification requirements. The provisions of § 721.185 apply to this section. § 721.7375 Potassium salt of polyolefin acid. [63 FR 3434, Jan. 22, 1998] (a) Chemical substance and significant § 721.7440 Polyalkylenepolyol alkyla- new uses subject to reporting. (1) The mine. (generic name). chemical substance identified generi- (a) Chemical substance and significant cally as a potassium salt of polyolefin new uses subject to reporting. (1) The acid (PMN P-97–417) is subject to re- chemical substance identified generi- porting under this section for the sig- cally as polyalkylenepolyol alkylamine nificant new uses described in paragraph (a)(2) of this section. (PMN P-89–483) is subject to reporting under this section for the significant (2) The significant new uses are: new uses described in paragraph (a)(2) (i) Industrial, commercial, and con- of this section. sumer activities. Requirements as specified in § 721.80(j). (2) The significant new uses are: (ii) [Reserved] (i) Protection in the workplace. Re- (b) Specific requirements. The provi- quirements as specified in § 721.63 (a)(1), sions of subpart A of this part apply to (a)(3), (b) (concentration set at 1.0 per- this section except as modified by this cent), and (c). paragraph. (ii) Hazard communication program. (1) Recordkeeping. Recordkeeping re- Requirements as specified in § 721.72 (a), quirements as specified in § 721.125 (a), (b), (c), (d), (e) (concentration set at 1.0 (b), (c), and (i) are applicable to manu- percent), (f), (g)(1)(iii), (g)(1)(iv), facturers, importers, and processors of (g)(1)(vi), (g)(1)(ix), (g)(2)(i), (g)(2)(iii), this substance. (g)(2)(v), and (g)(5). (2) Limitations or revocation of certain (iii) Industrial, commercial, and con- notification requirements. The provisions sumer activities. Requirements as speci- of § 721.185 apply to this section. fied in § 721.80 (l) and (q). (b) Specific requirements. The provi- [63 FR 3434, Jan. 22, 1998] sions of subpart A of this part apply to § 721.7378 Substituted this section except as modified by this polyoxyethylene. paragraph. (a) Chemical substance and significant (1) Recordkeeping. The following rec- new uses subject to reporting. (1) The ordkeeping requirements are applicable chemical substance identified generi- to manufacturers, importers, and proc- cally as a substituted polyoxyethylene essors of this substance, as specified in (PMN P-93–1654) is subject to reporting § 721.125 (a) through (i). under this section for the significant (2) Limitations or revocation of certain new uses described in paragraph (a)(2) notification requirements. The provisions of this section. of § 721.185 apply to this significant new (2) The significant new uses are: use rule. (i) Industrial, commercial, and con- (3) Determining whether a specific use is sumer activities. Requirements as speci- subject to this section. The provisions of fied in § 721.80(j) (use as an emulsifier § 721.1725(b)(1) apply to this section. for paint and adhesives). [55 FR 33307, Aug. 15, 1990, as amended at 55 (ii) [Reserved] FR 52276, Dec. 21, 1990. Redesignated and (b) Specific requirements. The provi- amended at 58 FR 29946, 29947, May 24, 1993; 58 sions of subpart A of this part apply to FR 34204, June 23, 1993]

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§ 721.7450 Aromatic amine polyols. (iii) Industrial, commercial, and consumer activities. Requirements as speci- (a) Chemical substances and significant fied in § 721.80(p) (volume set at 245,000 new uses subject to reporting. (1) The chemical substances identified generi- kg; aggregate manufacture and import cally as aromatic amine polyols (PMNs volume for PMNs P-90–404, P-90–405, P-93–212 and P-93–213) are subject to re- and P-90–406 combined). porting under this section for the sig- (b) Specific requirements. The provi- nificant new uses described in para- sions of subpart A of this part apply to graph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Industrial, commercial, and con- (1) Recordkeeping. The following rec- sumer activities. Requirements as speci- ordkeeping requirements are applicable fied in § 721.80(f). to manufacturers, importers, and proc- (ii) [Reserved] essors of this substance as specified in (b) Specific requirements. The provi- § 721.125 (a) through (i). sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this section. (1) Recordkeeping. Recordkeeping re- [56 FR 40214, Aug. 13, 1991. Redesignated at 58 quirements as specified in § 721.125 (a) FR 29947, May 24, 1993, as amended at 58 FR and (i) are applicable to manufactur- 34204, June 23, 1993] ers, importers, and processors of these substances. § 721.7500 Nitrate polyether polyol (ge- (2) Limitations or revocation of certain neric name). The provisions notification requirements. (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The [58 FR 51686, Oct. 4, 1993] chemical substance nitrate polyether polyol (PMN P88-2540) is subject to re- § 721.7480 Isocyanate terminated porting under this section for the sig- polyols. nificant new uses described in para- (a) Chemical substances and significant graph (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substances identified generi- (i) Hazard communication program. A cally as isocyanate terminated polyols significant new use of this substance is (P-90–404, P-90–405, and P-90–406) are any manner or method of manufacture, subject to reporting under this section import, or processing associated with for the significant new uses described any use of this substance without pro- in paragraph (a)(2) of this section. viding risk notification as follows. (2) The significant new uses are: (A) If as a result of the test data re- (i) Protection in the workplace. Re- quired under the section 5(e) consent quirements as specified in § 721.63 (a)(1), order for this substance, the employer (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i), becomes aware that this substance (a)(5)(ii), (a)(5)(iii), (a)(6)(ii), (b) (con- may present a risk of injury to human centration set at 1.0 percent) and (c). health, the employer must incorporate (ii) Hazard communication program. this new information, and any informa- Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 tion on methods for protecting against percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), such risk, into a Material Safety Data (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), Sheet (MSDS) as described in § 721.72(c) and (g)(5). The following additional within 90 days from the time the em- human health hazard statements shall ployer becomes aware of the new infor- appear on each label and MSDS re- mation. If this substance is not being quired by this paragraph: The sub- manufactured, imported, processed, or stance may cause eye irritation, lung used in the employer’s workplace, the effects, dermal sensitization, pul- employer must add the new informa- monary sensitization, or systemic ef- tion to an MSDS before the substance fects. is reintroduced into the workplace.

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(B) The employer must ensure that MSDSs do not apply when the written persons who have received, or will re- program and MSDS are not required ceive, this substance from the em- under § 721.72 (a) and (c), respectively. ployer are provided an MSDS as de- (iii) Industrial, commercial, and con- scribed in § 721.72(c) containing the in- sumer activities. Requirements as speci- formation required under paragraph fied in § 721.80(g) (as intermediates to (a)(2)(i)(A) within 90 days from the manufacture dyes for coloring pulp or time the employer becomes aware of paper only) and (q). the new information. (iv) Disposal. Requirements as speci- (ii) Industrial, commercial, and con- fied in § 721.85 (a)(1), (b)(1) and (c)(1). sumer activities. Requirements as speci- (v) Release to water. Requirements as fied in § 721.80(q). specified in § 721.90 (a)(2)(iv), (b)(2)(iv) (b) Specific requirements. The provi- and (c)(2)(iv). sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. The following rec- paragraph. ordkeeping requirements are applicable (1) Recordkeeping. The following rec- to manufacturers, importers, and proc- ordkeeping requirements are applicable essors of this substance, as specified in to manufacturers, importers, and proc- § 721.125 (a) through (c), (h) and (i). essors of this substance, as specified in (2) Limitations or revocation of certain § 721.125 (a) through (f), (i), (j) and (k). notification requirements. The provisions of § 721.185 apply to this significant new (2) Limitations or revocation of certain use rule. notification requirements. The provisions (3) Determining whether a specific use is of § 721.185 apply to this significant new subject to this section. The provisions of use rule. § 721.1725(b)(1) apply to this section. [55 FR 32418, Aug. 9, 1990. Redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR [55 FR 32418, Aug. 9, 1990. Redesignated and 34204, June 23, 1993] amended at 58 FR 29946, 29947, May 24, 1993; 58 FR 34204, June 23, 1993] § 721.7620 Alkyl(heterocyclicyl) phe- § 721.7600 Alkyl(heterocyclicyl) pheny- nylazohetero monocyclic polyone, lazohetero monocyclic polyone (ge- ((alkylimidazolyl) methyl) deriva- neric name). tive (generic name). (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance alkyl (heterocyc- chemical substance alkyl (heterocyclicyl) phenylazohetero monocyclic licyl) phenylazohetero monocyclic polyone (PMN P-85–1370) is subject to polyone, ((alkylimidazolyl) methyl) de- reporting under this section for the sig- rivative (PMN P-86–136) is subject to nificant new uses described in para- reporting under this section for the sig- graph (a)(2) of this section. nificant new uses described in para- (2) The significant new uses are: graph (a)(2) of this section. (i) Protection in the workplace. Re- (2) The significant new uses are: quirements as specified in § 721.63 (a)(1), (i) Protection in the workplace. Re- (a)(3), (a)(4), (a)(5)(iv) through quirements as specified in § 721.63 (a)(1), (a)(5)(vii), (a)(6)(i) through (a)(6)(iii), (a)(3), (a)(4), (a)(5)(iv) through (b) (concentration set at 1.0 percent), (a)(5)(vii), (a)(6)(i), (a)(6)(ii) and and (c). (a)(6)(iii), (b) (concentration set at 1.0 (ii) Hazard communication program. percent), and (c). Requirements as specified in § 721.72 (d), (ii) Hazard communication program. (e) (concentration set at 1.0 percent), Requirements as specified in § 721.72 (f) and (g)(1)(ix), (g)(2)(i) through (b)(2), (d), (e) (concentration set at 1.0 (g)(2)(v) and (g)(4). The provisions of percent), (f) and (g)(1)(ix), (g)(2)(i), § 721.72(d) requiring employees to be (g)(2)(ii), (g)(2)(iv), and (g)(2)(v). The provided with information on the loca- provisions of § 721.72(d) requiring em- tion and availability of a written haz- ployees to be provided with informa- ard communication program and tion on the location and availability of

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a written hazard communication pro- (1) Recordkeeping. Recordkeeping re- gram and MSDSs do not apply when quirements as specified in § 721.125 (a), the written program and MSDS are not (b), (c), and (k) are applicable to manu- required under § 721.72 (a) and (c), re- facturers, importers, and processors of spectively. The provision of § 721.72(g) this substance. requiring placement of specific infor- (2) Limitations or revocation of certain mation on an MSDS does not apply notification requirements. The provisions when an MSDS is not required under of § 721.185 apply to this section. § 721.72(c). [59 FR 27485, May 27, 1994] (iii) Industrial, commercial, and consumer activities. Requirements as speci- § 721.7700 Poly(oxy-1,2-ethanediyl), α- fied in § 721.80 (g), (k) and (q). The term hydro-w-(oxiranylmethoxy)-, ether intermediate as used in § 721.80(g) is de- with 2-ethyl-2-(hydroxymethyl)-1,3- fined as intermediate for manufacture propanediol (3:1). of dyes for coloring pulp or paper. (a) Chemical substance and signifi- (iv) Disposal. Requirements as speci- cant new uses subject to reporting. (1) fied in § 721.85 (a)(1), (b)(1) and (c)(1). The chemical substance identified as (v) Release to water. Requirements as poly(oxy-1,2-ethanediyl),a-hydro-w- specified in § 721.90 (a)(2), (b)(2) and (oxiranylmethoxy)-, ether with 2-ethyl- (c)(2). 2-(hydroxymethyl)-1,3-propanediol (3:1) (b) Specific requirements. The provi- (PMN P-88–2188) is subject to reporting sions of subpart A of this part apply to under this section for the significant this section except as modified by this new uses described in paragraph (a)(2) paragraph. of this section. (1) Recordkeeping. The following rec- (2) The significant new uses are: ordkeeping requirements are applicable (i) Protection in the workplace. Re- to manufacturers, importers, and proc- quirements as specified in § 721.63 (a)(1), essors of this substance, as specified in (a)(3), (a)(4), (a)(5)(viii), (a)(5)(ix), § 721.125 (a) through (c), (e), (f), (i) and (a)(6)(ii), and (b) (concentration set at (j). 0.1 percent). (2) Limitations or revocation of certain (ii) Hazard communication program. notification requirements. The provisions Requirements as specified in § 721.72 (a), of § 721.185 apply to this significant new (b), (c), (d), (e) (concentration set at 0.1 use rule. percent), (f), (g)(1)(vi), (g)(1)(vii), (3) Determining whether a specific use is (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), subject to this section. The provisions of (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5). § 721.1725(b)(1) apply to this section. (iii) Industrial, commercial, and con- [55 FR 32418, Aug. 9, 1990. Redesignated and sumer activities. Requirements as speci- amended at 58 FR 29946, 29947, May 24, 1993; 58 fied in § 721.80 (l) and (q). FR 34204, June 23, 1993] (iv) Disposal. Requirements as specified in § 721.85 (b)(1), (b)(2), (c)(1), and § 721.7655 Alkylsulfonium salt. (c)(2). (a) Chemical substance and significant (v) Release to water. Requirements as new uses subject to reporting. (1) The specified in § 721.90 (a)(2)(ii), (b)(1), and chemical substance identified generi- (c)(1). The following may be used as al- cally as alkylsulfonium salt (PMN P- ternative to the technologies in 93–1166) is subject to reporting under § 721.90(a)(2)(ii): Oil and grease separa- this section for the significant new tion. uses described in paragraph (a)(2) of (b) Specific requirements. The provi- this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Release to water. Requirements as paragraph. specified in § 721.90 (a)(4), (b)(4), and (1) Recordkeeping. The following rec- (c)(4) (where N = 50 ppb). ordkeeping requirements are applicable (ii) [Reserved] to manufacturers, importers, and proc- (b) Specific requirements. The provi- essors of this substance: § 721.125 (a) sions of subpart A of this part apply to through (k). this section except as modified by this (2) Limitation of revocation of certain paragraph. notification requirements. The provisions

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of § 721.185 apply to this significant new (b), (c), (d), (e) (concentration set at 0.1 use rule. percent), (f), (g)(1)(vi), (g)(1)(vii), (3) Determining whether a specific use is (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), subject to this section. The provisions of (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5). § 721.1725(b)(1) apply to this section. (iii) Industrial, commercial, and con- [56 FR 19240, Apr. 25, 1991. Redesignated and sumer activities. Requirements as speci- amended at 58 FR 29946, 29947, May 24, 1993; 58 fied in § 721.80 (l) and (q). FR 34204, June 23, 1993] (iv) Disposal. Requirements as specified in § 721.85 (b)(1), (b)(2), (c)(1), and § 721.7710 Polyepoxy polyol. (c)(2). (a) Chemical substance and significant (v) Release to water. Requirements as new uses subject to reporting. (1) The specified in § 721.90 (a)(2)(ii), (b)(1), and chemical substance identified generi- (c)(1). The following may be used as an cally as a polyepoxy polyol (PMN P-93– alternative to the technologies in 364) is subject to reporting under this § 721.90(a)(2)(ii): Oil and grease separa- section for the significant new uses de- tion. scribed in paragraph (a)(2) of this sec- (b) Specific requirements. The provi- tion. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Industrial, commercial and consumer paragraph. activities. Requirements as specified in (1) Recordkeeping. The following rec- § 721.80 (v)(1), (w)(1), and (x)(1). ordkeeping requirements are applicable (ii) [Reserved] to manufacturers, importers, and proc- (b) Specific requirements. The provi- essors of this substance: § 721.125 (a) sions of subpart A of this part apply to through (k). this section except as modified by this (2) Limitation of revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this significant new quirements as specified in § 721.125 (a), use rule. (b), (c), and (i) are applicable to manu- (3) Determining whether a specific use is facturers, importers, and processors of subject to this section. The provisions of this substance. § 721.1725(b)(1) apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [56 FR 19240, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, 29947, May 24, 1993; 58 of § 721.185 apply to this section. FR 34204, June 23, 1993] [59 FR 27485, May 27, 1994] § 721.7770 § 721.7720 Poly(oxy-1,2-ethanediyl), Alkylphenoxypoly(oxyethylene) sul- α,α′-[(1-methylethylidene) di-4,1- furic acid ester, substituted amine phenylene] bis [w-(oxiranyl- salt. methoxy)-. (a) Chemical substance and significant (a) Chemical substance and signifi- new uses subject to reporting. (1) The cant new uses subject to reporting. (1) chemical substance identified as alkyl The chemical substance identified as phenoxypoly(oxyethylene) sulfuric acid poly(oxy-1,2-ethanediyl), a,a′-[(1- ester, substituted amine salt (PMN P- methylethylidene) di-4,1-phenylene] bis 92–396) is subject to reporting under [w-(oxiranylmethoxy)- (PMN P-88–2181) this section for the significant new is subject to reporting under this sec- uses described in paragraph (a)(2) of tion for the significant new uses de- this section. scribed in paragraph (a)(2) of this sec- (2) The significant new uses are: (i) tion. Hazard communication program. Re- (2) The significant new uses are: quirements as specified in § 721.72 (a), (i) Protection in the workplace. Re- (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), quirements as specified in § 721.63 (a)(1), (g)(4)(iii), and (g)(5). (a)(3), (a)(4), (a)(5)(viii), (a)(5)(ix), (ii) Industrial, commercial, and con- (a)(6)(ii), and (b) (concentration set at sumer activities. Requirements as speci- 0.1 percent). fied in § 721.80(k). (ii) Hazard communication program. (iii) Release to water. Requirements as Requirements as specified in § 721.72 (a), specified in § 721.90(a)(1).

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(b) Specific requirements. The provi- to manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance: § 721.125 (a) this section except as modified by this through (k). paragraph. (2) Limitation of revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this significant new (b), (c), (f), (g), (h), (i), and (k) are ap- use rule. plicable to manufacturers, importers, (3) Determining whether a specific use is and processors of this substance. subject to this section. The provisions of (2) Limitations or revocation of certain § 721.1725(b)(1) apply to this section. notification requirements. The provisions [56 FR 19239, Apr. 25, 1991. Redesignated and of § 721.185 apply to this section. amended at 58 FR 29946, 29947, May 24, 1993; 58 (3) Determining whether a specific use is FR 34204, June 23, 1993] subject to this section. The provisions of § 721.1725(b)(1) apply to this section. § 721.7785 Substituted alkyl aminomethylene polyphosphonic [58 FR 51707, Oct. 4, 1993] acid, salt (generic). § 721.7780 Poly[oxy(methyl-1,2-ethane- (a) Chemical substance and significant diyl)], α,α′-(2,2-dimethyl-1,3-propan- new uses subject to reporting. (1) The ediyl)bis[w-(oxiranymethoxy)-. chemical substance identified generi- (a) Chemical substance and signifi- cally as a substituted alkylamino cant new uses subject to reporting. (1) methylene polyphosphonic acid, salt The chemical substance identified as (PMN P-97–1095) is subject to reporting poly[oxy(methyl-1,2-ethanediyl)], a,a,′- under this section for the significant (2,2-dimethyl-1,3-propanediyl)bis[w- new uses described in paragraph (a)(2) (oxiranymethoxy)- (PMN P-88–2180) is of this section. subject to reporting under this section (2) The significant new uses are: for the significant new uses described (i) Release to water. Requirements as in paragraph (a)(2) of this section. specified in § 721.90 (a)(1), (b)(1), and (2) The significant new uses are: (c)(1). (i) Protection in the workplace. Re- (ii) [Reserved] quirements as specified in § 721.63 (a)(1), (b) Specific requirements. The provi- (a)(3), (a)(4), (a)(5)(viii), (a)(5)(ix), sions of subpart A of this part apply to (a)(6)(ii), and (b) (concentration set at this section except as modified by this 0.1 percent). paragraph. (ii) Hazard communication program. (1) Recordkeeping. Recordkeeping re- Requirements as specified in § 721.72 (a), quirements as specified in § 721.125 (a), (b), (c), (d), (e) (concentration set at 0.1 (b), (c), and (k) are applicable to manu- percent), (f), (g)(1)(vi), (g)(1)(vii), facturers, importers, and processors of (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), this substance. (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5). (2) Limitations or revocation of certain (iii) Industrial, commercial, and con- notification requirements. The provisions sumer activities. Requirements as speci- of § 721.185 apply to this section. fied in § 721.80 (l) and (q). [63 FR 44581, Aug. 20, 1998] (iv) Disposal. Requirements as specified in § 721.85 (b)(1), (b)(2), (c)(1), and § 721.8079 Isophorone diisocyanate (c)(2). neopentyl glycol adipate poly- (v) Release to water. Requirements as urethane prepolymer. specified in § 721.90 (a)(2)(ii), (b)(1), and (a) Chemical substance and significant (c)(1). The following may be used as an new uses subject to reporting. (1) The alternative to the technologies in chemical substance identified generi- § 721.90(a)(2)(ii): Oil and grease separa- cally as isophorone diisocyanate tion. neopentyl glycol adipate polyurethane (b) Specific requirements. The provi- prepolymer (PMN P-94–1743) is subject sions of subpart A of this part apply to to reporting under this section for the this section except as modified by this significant new uses described in para- paragraph. graph (a)(2) of this section. Non-spray (1) Recordkeeping. The following rec- uses are exempt from the provisions of ordkeeping requirements are applicable this rule.

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(2) The significant new uses are: nificant new uses described in para- (i) Protection in the workplace. Re- graph (a)(2) of this section. quirements as specified in § 721.63 (a)(4), (2) The significant new uses are: (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(viii), (i) Industrial, commercial, and con- (a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(6)(i), sumer activities. Requirements as speci- (a)(6)(ii), (a)(6)(iv), and (b) (concentra- fied in § 721.80(y)(1). tion set at 1.0 percent), and (c). (ii) [Reserved] (ii) Hazard communication program. (b) Specific requirements. The provi- Requirements as specified in § 721.72 (a), sions of subpart A of this part apply to (b), (c), (d), (e) (concentration set at 1.0 this section except as modified by this percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), paragraph. (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (1) Recordkeeping. Recordkeeping re- and (g)(5). Manufacturers, importers, quirements as specified in § 721.125 (a), and processors who implement the (b), (c), and (i) are applicable to manu- product stewardship provisions of the facturers, importers, and processors of TSCA section 5(e) consent order for this substance. these substances are exempt from the (2) Limitations or revocation of certain requirements of § 721.63 and § 721.72. notification requirements. The provisions (iii) Industrial, commercial and con- of § 721.185 apply to this section. sumer activities. Requirements as speci- [58 FR 51686, Oct. 4, 1993] fied in § 721.80(q). (b) Specific requirements. The provi- § 721.8085 Reaction product of sub- sions of subpart A of this part apply to stituted aromatic diol, formaldehyde and alkanolamine, this section except as modified by this propoxylated (generic). paragraph. (1) Recordkeeping. Recordkeeping re- (a) Chemical substance and significant quirements as specified in § 721.125 (a) new uses subject to reporting. (1) The chemical substance identified generi- through (i) are applicable to manufac- cally as reaction product of substituted turers, importers, and processors of aromatic diol, formaldehyde and this substance. Manufacturers, import- alkanolamine, propoxylated (PMN P- ers, and processors who implement the 00–0202) is subject to reporting under product stewardship provisions and this section for the significant new use keep records as required by the TSCA described in paragraph (a)(2) of this section 5(e) consent order for these subsection. stances are exempt from the require- (2) The significant new uses are: ments of § 721.125. (i) Release to water. Requirements as (2) Limitations or revocation of certain specified § 721.90 (a)(1), (b)(1), and (c)(1). notification requirements. The provisions (ii) [Reserved] of § 721.185 apply to this section. (b) Specific requirements. The provi- (3) Determining whether a specific use is sions of subpart A of this part apply to subject to this section. The provisions of this section except as modified by this § 721.1725(b)(1) apply to this section. paragraph. (4) Applicability of § 721.5. The provi- (1) Recordkeeping. Recordkeeping re- sions of § 721.5 do not apply to manufac- quirements as specified in § 721.125 (a), turers, importers, and processors, im- (b), (c), and (k) are applicable to manu- plementing the product stewardship facturers, importers, and processors of provisions in the TSCA section 5(e) this substance. consent order for this substance. (2) Limitations or revocation of certain [63 FR 3435, Jan. 22, 1998] notification requirements. The provisions of § 721.185 apply to this section. § 721.8082 Polyester polyurethane ac- [68 FR 15088, Mar. 28, 2003] rylate. (a) Chemical substance and significant § 721.8090 Polyurethane polymer. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as polyester polyurethane acry- chemical substance identified generi- late (PMN P-93–498) is subject to re- cally as a polyurethane polymer (P-94– porting under this section for the sig- 47) is subject to reporting under this

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section for the significant new uses de- (2) Limitations or revocation of certain scribed in paragraph (a)(2) of this sec- notification requirements. The provisions tion. of § 721.185 apply to this section. (2) The significant new uses are: [63 FR 3435, Jan. 22, 1998] (i) Protection in the workplace. Re- quirements as specified in § 721.63 (a)(1), § 721.8100 Potassium N,N-bis (hydroxy- (a)(3), (a)(4), (a)(5)(iii), (a)(5)(viii) ethyl) cocoamine oxide phosphate, through (a)(5)(xi), (a)(6)(ii), (b) (con- and potassium N,N-bis (hydroxy- centration set at 1.0 percent), and (c). ethyl) tallowamine oxide phos- (ii) Hazard communication program. phate. Requirements as specified in § 721.72 (a), (a) Chemical substances and significant (b), (c), (d), (e) (concentration set at 1.0 new use subject to reporting. (1) The fol- percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i) lowing chemical substances, identified through (g)(2)(v), and (g)(5). by their chemical names and CAS (iii) Industrial, commercial, and con- Number are subject to reporting under sumer activities. Requirements as speci- this part for the significant new use fied in § 721.80(q). identified in paragraph (a)(2) of this (b) Specific requirements. The provi- section: Potassium N,N-bis (hydroxy- sions of subpart A of this part apply to ethyl) cocoamine oxide phosphate (CAS this section except as modified by this paragraph. Number 855712–26–1), and potassium N,N-bis (hydroxyethyl) tallowamine (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a) oxide phosphate (CAS Number 855712– through (i) are applicable to manufac- 27–2). turers, importers, and processors of (2) The significant new use is: Use in this substance. a consumer product at concentrations (2) Limitations or revocation of certain greater than five percent by weight. notification requirements. The provisions (b) Specific Requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to (3) Determining whether a specific use is this section except as modified by this subject to this section. The provisions of paragraph. § 721.1725(b)(1) apply to this section. (1) Definitions. In addition to the definitions in § 721.3, the following defini- [60 FR 45084, Aug. 30, 1995] tions apply to this section: § 721.8095 Silylated polyurethane. ‘‘Consumer’’ means any natural person who uses products for personal (a) Chemical substance and significant rather than business purposes. new uses subject to reporting. (1) The ‘‘Consumer product’’ means any chemical substance identified generi- chemical substance which is directly, cally as a silylated polyurethane (PMN or as part of a mixture, sold or made P-95–1356) is subject to reporting under this section for the significant new available to consumers for their use in uses described in paragraph (a)(2) of or around a permanent or temporary this section. household or residence, in or around a (2) The significant new uses are: school, or in recreation. (i) Industrial, commercial, and con- (2) Persons who must report. The provi- sumer activities. Requirements as speci- sions of § 721.5 apply to determine per- fied in § 721.80(y)(1). sons who must report under this sec- (ii) [Reserved] tion, except § 721.5(a)(2) does not apply (b) Specific requirements. The provi- to a person who intends to distribute sions of subpart A of this part apply to either of the substances in commerce this section except as modified by this as part of a mixture at concentrations paragraph. of five percent or less by weight of the (1) Recordkeeping. Recordkeeping re- mixture. quirements as specified in § 721.125 (a), (3) Notice requirements and procedures. (b), (c), and (i) are applicable to manu- Section 721.10 applies to this section, facturers, importers, and processors of except a person submitting a notice this substance.

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must complete only Parts I and II of (b), (c), and (i) are applicable to manu- the notice form. facturers, importers, and processors of this chemical substance. [49 FR 35018, Sept. 5, 1984. Redesignated at 53 FR 2845, Feb. 2, 1988. Further redesignated at (2) Limitations or revocation of certain 58 FR 29947, May 24, 1993, as amended at 58 notification requirements. The provisions FR 34204, June 23, 1993] of § 721.185 apply to this section.

§ 721.8130 Propanamide, -(2-hydroxy- [68 FR 70181, Dec. 17, 2003] ethyl)-3-methoxy-. § 721.8145 Propane,1,1,1,2,2,3,3- (a) Chemical substance and significant heptafluoro-3-methoxy-. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified as new uses subject to reporting. (1) The propanamide, -(2-hydroxyethyl)-3- chemical substance identified as pro- methoxy- (PMN P-01–144; CAS No. 35544–45–7) is subject to reporting under pane,1,1,1,2,2,3,3-heptafluoro-3- this section for the significant new use methoxy- (PMN P-01–320; CAS No. 375– described in paragraph (a)(2) of this 03–1) is subject to reporting under this section. section for the significant new use de- (2) The significant new uses are: scribed in paragraph (a)(2) of this sec- (i) Industrial, commercial, and con- tion. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80(j) (organic stripper addi- (i) Industrial, commercial, and con- tive). sumer activities. Requirements as speci- (ii) [Reserved] fied § 721.80(j) (heating transfer fluid (b) Specific requirements. The provi- and a refrigerant) and (s) (100,000 kg) sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125(a), paragraph. (b), (c), and (i) are applicable to manu- (1) Recordkeeping. Recordkeeping re- facturers, importers, and processors of quirements as specified in § 721.125(a), this chemical substance. (b), (c), and (i) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this chemical substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [68 FR 70181, Dec. 17, 2003] of § 721.185 apply to this section. § 721.8140 Substituted propane (ge- [68 FR 70181, Dec. 17, 2003] neric). (a) Chemical substance and significant § 721.8153 Di-substituted propanedione new uses subject to reporting. (1) The (generic). chemical substance identified generi- (a) Chemical substance and significant cally as a substituted propane (PMN P- new uses subject to reporting. (1) The 01–298) is subject to reporting under chemical substance identified generi- this section for the significant new use cally as di-substituted propanedione described in paragraph (a)(2) of this (PMN P-97–94) is subject to reporting section. under this section for the significant (2) The significant new uses are: new uses described in paragraph (a)(2) (i) Industrial, commercial, and con- of this section. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80(j) (polymer additive). (i) Protection in the workplace. Re- (ii) [Reserved] quirements as specified in § 721.63 (a)(1), (b) Specific requirements. The provi- (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (b) sions of subpart A of this part apply to (concentration set at 1.0 percent), and this section except as modified by this (c). paragraph. (ii) Hazard communication program. (1) Recordkeeping. Recordkeeping re- Requirements as specified in § 721.72 (a), quirements as specified in § 721.125(a), (b), (c), (d), (e) (concentration set at 1.0

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percent), (f), (g)(2)(i), (g)(2)(v). The fol- (b) Specific requirements. The provi- lowing statement shall appear on each sions of subpart A of this part apply to label as specified in § 721.72(b) and the this section except as modified by this MSDS as specified in § 721.72(c): This paragraph. substance is expected to be dermally (1) Recordkeeping requirements. Rec- absorbed and may cause effects to the ordkeeping requirements specified in liver, kidney, adrenal glands, and the § 721.125 (a), (b), (c), and (k) are applica- heart. ble to manufacturers, importers, and (iii) Industrial, commercial, and con- processors of this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(q). notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to this section except as modified by this [60 FR 11044, Mar. 1, 1995] paragraph. (1) Recordkeeping. Recordkeeping re- § 721.8160 Propanoic acid, 2,2-dimethyl-, ethenyl ester. quirements as specified in § 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are (a) Chemical substance and significant applicable to manufacturers, import- new uses subject to reporting. (1) The ers, and processors of this substance. chemical substance identified as pro- (2) Limitations or revocation of certain panoic acid, 2,2-dimethyl-, ethenyl notification requirements. The provisions ester (PMN P-89–1058) is subject to re- of § 721.185 apply to this section. porting under this section for the sig- (3) Determining whether a specific use is nificant new uses described in para- subject to this section. The provisions of graph (a)(2) of this section. The re- § 721.1725(b)(1) apply to this section. quirements of this section do not apply once the substance has been incor- [63 FR 44581, Aug. 20, 1998] porated into a polymer matrix with the § 721.8155 Propanenitrile, 3-[amino, N- level of residual monomer below 0.1 tallowalkyl] dipropylenetri- and percent. tripropylenetri- and propanenitrile, (2) The significant new uses are: (i) 3-[amino, (C14-18 and C16-18 unsatu- Protection in the workplace. Require- rated alkyl)] trimethylenedi-, ments as specified in § 721.63 (a)(1), dipropylenetri-, and (a)(2)(i) (There must be no permeation tripropylenetetra-. of the substance greater than 0.02 μg/ (a) Chemical substances and significant min · cm2 after 8 hours of testing in ac- new uses subject to reporting. (1) The cordance with the most current version chemical substances identified as of the American Society for Testing propanenitrile, 3-[amino, N- and Materials ASTM F739 ‘‘Standard tallowalkyl] dipropylenetri- (PMN P-94 Test Method for Resistance of Protec- 1238), propanenitrile, 3-[amino, N- tive Clothing Materials to Permeation tallowalkyl] tripropylenetri- (PMN P- by Liquids or Gases.’’ For conditions of 94–1239), propanenitrile, 3-[amino, exposure which are intermittent, (C14-18 and C16-18 unsaturated alkyl)] gloves may be tested in accordance trimethylenedi- (PMN P-94–1241), with the most current version of ASTM propanenitrile, 3-[amino, (C14-18 and F1383 ‘‘Standard Test Method for Re- C16-18 unsaturated alkyl)] sistance of Protective Clothing Mate- dipropylenetri- (PMN P-94–1242), and rials to Permeation by Liquids or propanenitrile, 3-[amino, (C14-18 and Gases Under Conditions of Intermit- C16-18 unsaturated alkyl)] tent Contact,’’ provided the contact tripropylenetetra- (PMN P-94–1243) are time in testing is greater than or equal subject to reporting under this section to the expected duration of dermal con- for the significant new uses described tact, and the purge time used in test- in paragraph (a)(2) of this section. ing is less than or equal to the ex- (2) The significant new uses are: pected duration of noncontact during (i) Release to water. Requirements as the intermittent cycle of dermal expo- specified in § 721.90 (a)(1), (b)(1), and sure in the workplace. If ASTM F1383 is (c)(1). used for testing, manufacturers, im- (ii) [Reserved] porters, and processors must submit to

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the Agency a description of worker ac- (a)(5)(xii) or (a)(5)(xiii) (if data on car- tivities involving the substance which tridge service life testing has been re- includes daily frequencies and dura- viewed and approved in writing by tions of potential worker exposures. EPA), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), and The results of all glove permeation (a)(6)(v). As an alternative to the res- testing must be reported in accordance piratory requirements in this section, with the most current version of ASTM manufacturers, importers, and proc- F1194 ‘‘Guide for Documenting the Re- essors may use the New Chemical Ex- sults of Chemical Permeation Testing posure Limits provisions, including of Protective Clothing Materials.’’ sampling and analytical methods Manufacturers, importers, and proc- which have previously been approved essors must submit all test data to the by EPA for this substance, found in the Agency and must receive written Agen- 5(e) consent order for this substance. cy approval for each type of glove test- (ii) Hazard communication program. ed prior to use of such gloves. The fol- Requirements as specified in § 721.72 (a), lowing gloves have been tested in ac- (b), (c), (d), (e) (concentration set at 0.1 cordance with the ASTM F739 method percent), (f), (h)(1)(vi) (The following and found by EPA to satisfy the re- additional statements shall appear on quirements for continuous use: Ansell each label required by this paragraph: Edmont/15-554/PVA, 0.08 cm thick; and The health effects of this material Ansell Edmont/4h/PE/EVOH/PE lami- have not been fully determined but are nate gloves, 0.006 cm thick. Gloves may currently being tested. EPA is con- not be used for a time period longer cerned however, that this material than they are actually tested and must may have serious chronic health and be replaced at the end of each work environmental effects. When using this shift. The following gloves have been material, use eye and skin protection, tested in accordance with the ASTM which includes gloves which have been 1383 method and found by EPA to sat- determined to be impervious to this isfy the requirements for intermittent substance. Use respiratory protection, use: North/B-161-R/Butyl rubber gloves, unless workplace airborne concentra- 0.04 cm thick, time period tested 2 min/ tions are maintained at or below an 8– h. The gloves listed may not be used for a time period longer than they are h time weighted average (TWA) of 1 actually tested and must be replaced at ppm, when there is a likelihood of ex- the end of each work shift unless based posure in the work area from dust, on its review of data from the ASTM mist, smoke or vapor), (h)(2)(ii)(F), 1383 method, the company’s personal (h)(2)(ii)(G), (h)(2)(ii)(I), (h)(2)(iii)(A), protective equipment required under (h)(2)(iii)(B), (h)(2)(iii)(C), (h)(2)(iii)(E), this paragraph, and other appropriate (h)(2)(iv)(A), (h)(2)(iv)(B). The following information, the Agency approves, in additional statements shall appear on writing, a time period of greater dura- each MSDS required by this paragraph: tion.), (a)(2)(ii) (With the exception of This substance may cause moderate laboratory activities, full body chem- skin irritation. This substance may ical protective clothing is required for cause neurotoxicity. When using this any worker activity in which the sub- substance, use respiratory protection, stance is reasonably likely to contact unless workplace airborne concentra- the worker in the following state(s): tions are maintained at or below an 8– Open liquid pool or solid of greater h TWA of 1 ppm. than 5 kg; liquid spray or splash; mist; (iii) Industrial, commercial, and con- aerosol dust; or any worker activity sumer activities. Requirements as speci- which has the potential for contact fied in § 721.80(q). with the substance for more than 10 (iv) Release to water. Requirements as min/h. At a minimum, a chemical pro- specified in § 721.90 (a)(4), (b)(4), and tective apron is required for any work- (c)(4) (where N = 40 ppb). When calcu- er activity with potential for contact lating the surface water concentrations with the substance which is not cov- according to the instructions in § 721.91, ered by this paragraph), (a)(2)(iii), the statement in paragraph (a)(4) that (a)(3), (a)(4), (a)(5)(iii) (if cartridge the amount of the substance that will service life testing is not available), be released will be calculated before

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the substance enters control tech- (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), nology does not apply. Instead, if the (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), waste stream containing the substance (a)(5)(xiv), (a)(6)(v), (b) (concentration will be treated before release, then the set at 1%), and (c). amount of the substance reasonably (ii) Hazard communication program. likely to be removed from the waste Requirements as specified in § 721.72 (a), stream by such treatment may be sub- (b), (c), (d), (e) (concentration set at tracted in calculating the number of 1%), (f), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), kilograms released. No more than 75 (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5). percent removal efficiency may be at- (iii) Industrial, commercial, and contributed to such treatment. In addi- sumer activities. Requirements as speci- tion, when the substance is released in fied in § 721.80(g). combination with the substances (iv) Disposal. Requirements as speci- hexanedioic acid, diethenyl ester, fied in § 721.85 (a)(1), (a)(2), (a)(3), (b)(1), hexanoic acid, 2-ethyl-, ethenyl ester, (b)(2), (b)(3), (c)(1), (c)(2), and (c)(3). In and neononanoic acid, ethenyl ester, the quotient from the formula ref- addition, a method of disposal de- erenced in this section shall not exceed scribed in § 721.85 (a), (b), and (c) shall the average of the quotient applicable include: Release to an evaporation to the other substances weighted by pond. the proportion of each substance (b) Specific requirements. The provi- present in the total daily amount re- sions of subpart A of this part apply to leased. this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. The following rec- this section except as modified by this ordkeeping requirements are applicable paragraph. to manufacturers, importers, and proc- (1) Recordkeeping. Recordkeeping re- essors of this substance as specified in quirements as specified in § 721.125 (a) § 721.125 (a) through (j). through (i), and (k) are applicable to (2) Limitations or revocation of certain manufacturers, importers, and proc- notification requirements. The provisions essors of this substance. Manufactur- of § 721.185 apply to this section. ers, importers, and processors of the substance must document that the sub- [67 FR 17649, Apr. 11, 2002] stance has been incorporated into a polymer matrix with the level of resid- § 721.8225 2-Propenamide, N-[3-dimethylamino)propyl]-. ual monomer below 0.1 percent if this section does not apply as described in (a) Chemical substance and significant paragraph (a)(1) of this section. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified as 2- notification requirements. The provisions propenamide, N-[3-dimethyla- of § 721.185 apply to this section. mino)propyl]- (PMN P-86–1602) is sub- (3) Determining whether a specific use is ject to reporting under this section for subject to this section. The provisions of the significant new uses described in § 721.1725(b)(1) apply to this section. paragraph (a)(2) of this section. [58 FR 51707, Oct. 4, 1993] (2) The significant new uses are: (i) Protection in the workplace. Re- § 721.8175 1-Propanol, 3-mercapto-. quirements as specified in § 721.63(a)(1), (a) Chemical substance and significant (a)(2)(i), (a)(3), (a)(6)(ii), (b) (concentra- new uses subject to reporting. (1) The tion set at 0.1 percent) and (c). chemical substance identified as 1-pro- (ii) Hazard communication program. panol, 3-mercapto (PMN P-85–433; CAS Requirements as specified in § 721.72(a), No. 19721–22–3) is subject to reporting (b), (c), (d), (e) (concentration set at 0.1 under this section for the significant percent), (f), (g)(1)(iii), (g)(1)(v), new uses described in paragraph (a)(2) (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(v), of this section. (g)(5). (2) The significant new uses are: (iii) Industrial, commercial, and con- (i) Protection in the workplace. Re- sumer activities. Requirements as speci- quirements as specified in § 721.63 (a)(1), fied in § 721.80 (o) and (q).

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(iv) Release to water. Requirements as this section except as modified by this specified in § 721.90(a)(4), (b)(4), and paragraph. (c)(4) (where N = 300 ppb). (1) Recordkeeping requirements. Re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a) sions of subpart A of this part apply to through (i), and (j) are applicable to this section except as modified by this manufacturers, importers, and proc- paragraph. essors of this substance. (1) Recordkeeping. The following rec- (2) Limitations or revocation of certain ordkeeping requirements are applicable notification requirements. The provisions to manufacturers, importers, and proc- of § 721.185 apply to this section. essors of this substance, as specified in (3) Determining whether a specific use is § 721.125 (a) through (i) and (k). subject to this section. The provisions of (2) Limitations or revocation of certain § 721.1725(b)(1) apply to this section. notification requirements. The provisions [57 FR 44072, Sept. 23, 1992, as amended at 58 of § 721.185 apply to this significant new FR 29946, May 24, 1993; 58 FR 34204, June 23, use rule. 1993] (3) Determining whether a specific use is § 721.8340 Mono esters from 2- prope- subject to this section. The provisions of noic acid (generic). § 721.1725(b)(1) apply to this section. (a) Chemical substance and significant [56 FR 40215, Aug. 13, 1991. Redesignated and new uses subject to reporting. (1) The amended at 58 FR 29946, 29947, May 24, 1993; 58 chemical substance identified generi- FR 34204, June 23, 1993] cally as mono esters from 2-propenoic acid (PMN P-01–85) is subject to report- § 721.8250 1-Propanol, 3,3′-oxybis[2,2- bis(bromomethyl)-. ing under this section for the significant new use described in paragraph (a) Chemical substance and significant (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified as 1-pro- (i) Release to water. Requirements as panol, 3,3′-oxybis[2,2- specified § 721.90(a)(1), (b)(1), and (c)(1). bis(bromomethyl)]- (PMN P-87–1273) is (ii) [Reserved] subject to reporting under this section (b) Specific requirements. The provi- for the significant new uses described sions of subpart A of this part apply to in paragraph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Protection in the workplace. Re- (1) Recordkeeping. Recordkeeping requirements as specified in quirements as specified in § 721.125(a), § 721.63(a)(2)(i), (a)(2)(iii), (a)(2)(iv), (b), (c), and (k) are applicable to manu- (a)(3)(applies to gloves only), (a)(4), facturers, importers, and processors of (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), this chemical substance. (a)(6)(i), (a)(6)(ii), (b) (concentration set (2) Limitations or revocation of certain at 0.1 percent), and (c). notification requirements. The provisions (ii) Hazard communication program. of § 721.185 apply to this section. Requirements asspecified in § 721.72(a), [68 FR 70181, Dec. 17, 2003] (b)(2), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(iv), (g)(1)(vi), § 721.8350 2-Propenoic acid, 7- (g)(1)(vii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), oxabicyclo[4.1.0]hept-3-ylmethyl (g)(2)(iii), (g)(2)(v), and (g)(5). In addi- ester. tion, the human health hazard state- (a) Chemical substance and significant ment shall include a statement that new uses subject to reporting. (1) The this substance may cause acute and chemical substance 2-propenoic acid, 7- chronic toxicity. oxabicyclo[4.1.0]hept-3-ylmethyl ester (iii) Industrial, commercial, and con- (PMN P-89–31) is subject to reporting sumer activities. Requirements as speci- under this section for the significant fied in § 721.80 (f) and (p). In addition, new uses described in paragraph (a)(2) use other than as a flame retardant ad- of this section. ditive is a significant new use. (2) The significant new uses are: (b) Specific requirements. The provi- (i) Protection in the workplace. Re- sions of subpart A of this part apply to quirements as specified in § 721.63 (a)(1),

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(a)(3), (a)(4), (a)(5)(viii), (a)(5)(xv), (iii) Industrial, commercial, and con- (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (consumer activities. Requirements as speci- centration set at 0.1 percent), and (c). fied in § 721.80 (l) and (q). (ii) Hazard communication program. (iv) Release to water. Requirements as Requirements as specified in § 721.72 (a), specified in § 721.90 (a)(4), (b)(4), (c)(4), ( (b), (c), (d), (e) (concentration set at 0.1 where N = 80 ). However, contrary to percent), (f), (g)(1)(iii), (g)(1)(vi), § 721.91(a)(4), if the waste stream con- (g)(1)(vii), (g)(2)(i) through (g)(2)(v), and taining the PMN substance will be (g)(5). treated using biological treatment (ac- (iii) Industrial, commercial, and con- tivated sludge or equivalent) plus clari- sumer activities. Requirements as specification, then the amount of PMN sub- fied in § 721.80(o). stance reasonably likely to be removed (iv) Release to water. Requirements as from the waste stream by such treat- specified in § 721.90 (a)(1), (b)(1), and ment may be subtracted in calculating (c)(1). the number of kilograms released. No (b) Specific requirements. The provi- more than 75 percent removal effi- sions of subpart A of this part apply to ciency may be attributed to such treat- this section except as modified by this ment. paragraph. (b) Special requirements. The provi- (1) Recordkeeping. The following rec- sions of subpart A of this part apply to ordkeeping requirements are applicable this section except as modified by this to manufacturers, importers, and proc- paragraph. essors of this substance, as specified in (1) Recordkeeping. The following rec- § 721.125 (a) through (i). ordkeeping requirements are applicable (2) Limitations or revocation of certain to manufacturers, importers, and proc- notification requirements. The provisions essors of this substance: § 721.125 (a) of § 721.185 apply to this significant new through (i), and (k). use rule. (2) Limitations or revocation of certain notification requirements. The provisions [55 FR 46774, Nov. 6, 1990. Redesignated at 58 of § 721.185 apply to this significant new FR 29947, May 24, 1993, as amended at 58 FR 34204, June 23, 1993; 62 FR 42692, Aug. 8, 1997] use rule. (3) Determining whether a specific use is § 721.8450 2-Propenoic acid, 2-methyl-, subject to this section. The provisions of 2-[3-(2H-benzotriazol-2-yl)-4- § 721.1725(b)(1) apply to this section. hydroxyphenyl]ethyl ester. [56 FR 19241, Apr. 25, 1991. Redesignated and (a) Chemical substance and significant amended at 58 FR 29946, 29947, May 24, 1993; 58 new uses subject to reporting. (1) The FR 34204, June 23, 1993; 60 FR 30468, June 9, chemical substance identified as 2-pro- 1995; 63 FR 45956, Aug. 28, 1998] penoic acid, 2-methyl-, 2-[3-(2H- benzotriazol-2-yl)-4- § 721.8485 2-Propenoic acid, 2-methyl-, hydroxyphenyl]ethyl ester, (PMN P-90– (octahydro-4,7-methano-1H- indene- 333) is subject to reporting under this 5-diyl)bis(methylene) ester. section for the significant new uses de- (a) Chemical substance and significant scribed in paragraph (a)(2) of this sec- new uses subject to reporting. (1) The tion. chemical substance identified as 2-pro- (2) The significant new uses are: penoic acid, 2-methyl-, (octahydro-4,7- (i) Protection in the workplace. Re- methano- 1H- indene-5- quirements as specified in § 721.63 (a)(1), diyl)bis(methylene) ester (PMN P-99– (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), 1075; CAS No. 43048–08–4) is subject to (a)(5)(v), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) reporting under this section for the sig- (concentration set at 1.0 percent), and nificant new use described in paragraph (c). (a)(2) of this section. (ii) Hazard communication program. (2) The significant new uses are: Requirements as specified in § 721.72 (a), (i) Industrial, commercial, and con- (b), (c), (d), (e) (concentration set at 1.0 sumer activities. Requirements as speci- percent), (f), (g)(1)(i), (g)(1)(ii), fied in § 721.80(f). (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), (g)(2)(i), (ii) Release to water. Requirements as (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5). specified in § 721.90(b)(1) and (c)(1).

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(b) Specific requirements. The provi- § 721.8657 Cerium, hydroxy oleate pro- sions of subpart A of this part apply to pionate complexes. this section except as modified by this (a) Chemical substance and significant paragraph new uses subject to reporting. (1) The (1) Recordkeeping. Recordkeeping re- chemical substance identified as Ce- quirements as specified in § 721.125(a), rium, hydroxy oleate propionate com- (b), (c), (i), and (k) are applicable to plexes (PMN P-99–0026) is subject to re- manufacturers, importers, and proc- porting under this section for the sig- essors of these chemical substance. nificant new use described in paragraph (2) Limitations or revocation of certain (a)(2) of this section. notification requirements. The provisions (2) The significant new uses are: of § 721.185 apply to this section. (i) Release to water. Requirements as [68 FR 70182, Dec. 17, 2003] specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=7 ppb). § 721.8500 2-Propenoic acid, 2-methyl-, (ii) [Reserved] 7-oxabicyclo [4.1.0]hept-3-ylmethyl (b) Specific requirements. The provi- ester. sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance 2-propenoic acid, 2- (1) Recordkeeping. Recordkeeping re- methyl-, 7-oxabicyclo[4.1.0]hept-3- quirements as specified in § 721.125 (a), ylmethyl ester (PMN P-89–30) is subject (b), (c), and (k) are applicable to manu- to reporting under this section for the facturers, importers, and processors of significant new uses described in para- this substance. graph (a)(2) of this section. (2) Limitations or revocation of certain (2) The significant new uses are: notification requirements. The provisions (i) Protection in the workplace. Re- of § 721.185 apply to this section. quirements as specified in § 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(viii), (a)(5)(xv), [65 FR 81403, Dec. 26, 2000] (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (concentration set at 0.1 percent), and (c). § 721.8658 Modified polymer of vinyl acetate and quaternary ammonium (ii) Hazard communication program. compound (generic). Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 (a) Chemical substance and significant percent), (f), (g)(1)(iii), (g)(1)(vi), new uses subject to reporting. (1) The (g)(1)(vii), (g)(2)(i) through (g)(2)(v), and chemical substance identified generi- (g)(5). cally as modified polymer of vinyl ace- (iii) Industrial, commercial, and con- tate and quaternary ammonium com- sumer activities. Requirements as speci- pound (PMN P-99–0874) is subject to re- fied in § 721.80(o). porting under this section for the sig- (b) Specific requirements. The provi- nificant new use described in paragraph sions of subpart A of this part apply to (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Industrial, commercial, and con- (1) Recordkeeping. The following rec- sumer activities. Requirements as speci- ordkeeping requirements are applicable fied in § 721.80(f). to manufacturers, importers, and proc- (ii) [Reserved] essors of this substance, as specified in (b) Specific requirements. The provi- § 721.125 (a) through (i). sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this significant new (1) Recordkeeping. Recordkeeping reuse rule. quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- [55 FR 46775, Nov. 6, 1990. Redesignated at 58 facturers, importers, and processors of FR 29947, May 24, 1993, as amended at 58 FR 34204, June 23, 1993] this substance.

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(2) Limitations or revocation of certain ble to manufacturers, importers, and notification requirements. The provisions processors of this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [68 FR 15088, Mar. 28, 2003] of § 721.185 apply to this section. § 721.8660 Propionic acid methyl ester [60 FR 11044, Mar. 1, 1995] (generic). (a) Chemical substance and significant § 721.8673 [(Disubstituted phenyl)]azo new uses subject to reporting. (1) The dihydro hydroxy alkyl oxo alkyl- substituted-pyridines (generic chemical substance identified generi- name). cally as a propionic acid methyl ester (PMN P-97–370) is subject to reporting (a) Chemical substance and significant under this section for the significant new uses subject to reporting. (1) The new uses described in paragraph (a)(2) chemical substances identified generically as [(disubstituted phenyl)]azo of this section. dihydro hydroxy alkyl oxo alkyl-sub- (2) The significant new uses are: stituted-pyridines (PMN P-95–510/511) (i) Protection in the workplace. Re- are subject to reporting under this sec- quirements as specified in § 721.63 (a)(1), tion for the significant new uses de- (a)(2)(i), and (a)(3). scribed in paragraph (a)(2) of this sec- (ii) Industrial, commercial, and con- tion. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80 (f) and (j). (i) Industrial, commercial, and con- (b) Specific requirements. The provi- sumer activities. Requirements as speci- sions of subpart A of this part apply to fied in § 721.80(f). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. The recordkeeping sions of subpart A of this part apply to requirements specified in § 721.125 (a), this section except as modified by this (b), (c), (d), (e), and (i) are applicable to paragraph. manufacturers, importers, and proc- (1) Recordkeeping. Recordkeeping re- essors of this substance. quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), and (i) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this substance. [63 FR 44581, Aug. 20, 1998] (2) Limitations or revocation of certain notification requirements. The provisions § 721.8670 Alkylcyano substituted of § 721.185 apply to this significant new pyridazo benzoate. use rule. (a) Chemical substance and significant [61 FR 63739, Dec. 2, 1996] new uses subject to reporting. (1) The chemical substance identified generi- § 721.8675 Halogenated pyridines. cally as an alkylcyano substituted (a) Chemical substances and significant pyridazo benzoate (PMN P-94–1129) is new uses subject to reporting. (1) The subject to reporting under this section chemical substance identified generi- for the significant new uses described cally as halogenated pyridine (PMN P- in paragraph (a)(2) of this section. 83–1163) is subject to reporting under (2) The significant new uses are: this section for the significant new (i) Release to water. Requirements as uses described in paragraph (a)(1)(i) of specified in § 721.90 (a)(1), (b)(1), and this section. (c)(1). (i) The significant new uses are: (ii) [Reserved] (A) Protection in the workplace. The (b) Specific requirements. The provi- general requirements as specified in sions of subpart A of this part apply to § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), this section except as modified by this (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), paragraph. (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), (1) Recordkeeping requirements. Rec- (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), ordkeeping requirements specified in (a)(6)(v), (a)(6)(vi), and (c) apply in all § 721.125 (a), (b), (c), and (k) are applica- cases except that § 721.63(a)(2)(ii) does

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not apply for reactor sampling oper- not apply for reactor sampling operations where enclosed vented sample ations where enclosed vented sample boxes are used. In addition boxes are used. In addition § 721.63(a)(2)(iv) applies for processing § 721.63(a)(2)(iv) applies for processing of any byproduct generated during of any byproduct generated during manufacturing, processing, or use of manufacturing, processing, or use of the chemical substance which contain the chemical substance which contains residual amounts of the chemical sub- residual amounts of the chemical substance. stance. (B) Hazard communication program. (B) Hazard communication program. Requirements as specified in § 721.72 (a), Requirements as specified in § 721.72 (a), (b), (c), (d), (f), (g)(1)(iv), (g)(2)(i), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5). (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). (C) Disposal. Requirements as speci- (C) Disposal. Requirements as specified in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following addi- (c)(1), and (c)(2). The following additional disposal methods also apply: tional disposal methods also apply: Chemical destruction or, where nec- Chemical destruction or, where necessary to ensure complete destruction essary to ensure complete destruction of the substance, chemical destruction of the substance, chemical destruction and carbon adsorption. and carbon adsorption. (D) Release to water. Requirements as (D) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and specified in § 721.90 (a)(4), (b)(4), and (c)(4) (concentration set at 0.2 ppb). (c)(4) (concentration set at 0.2 ppb). Where primary, secondary, and ter- Where primary, secondary, and tertiary waste treatment will occur, or tiary waste treatment will occur, or treatment in a lined, self-contained treatment in a lined, self-contained solar evaporation pond where UV light solar evaporation pond where UV light will degrade the substance, the number will degrade the substance, the number of kilograms per day per site is cal- of kilograms per day per site is calculated after wastewater treatment. culated after wastewater treatment. (ii) Specific requirements. The provi- (ii) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (A) Recordkeeping. The following rec- (A) Recordkeeping. The following recordkeeping requirements are applicable ordkeeping requirements are applicable to manufacturers, importers, and proc- to manufacturers, importers, and processors of this substance: § 721.125 (a) essors of this substance: § 721.125 (a) through (h), (j), and (k). through (h), (j), and (k). (B) Limitations or revocation of certain (B) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. (2) The chemical substances identi- (b) [Reserved] fied generically as halogenated [56 FR 23769, May 23, 1991; 56 FR 29903, July pyridines (PMN P-85–216, P-85–1184) is 1, 1991. Redesignated at 58 FR 29947, May 24, subject to reporting under this section 1993, as amended at 58 FR 34204, June 23, 1993; for the significant new uses described 59 FR 66747, Dec. 28, 1994] in paragraph (a)(4)(i) of this section. (i) The significant new uses are: § 721.8700 Halogenated alkyl pyridine. (A) Protection in the workplace. The (a) Chemical substances and significant general requirements as specified in new uses subject to reporting. (1) The § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), chemical substance identified generi- (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), cally as halogenated alkyl pyridine (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), (PMN P-83–237) is subject to reporting (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), under this section for the significant (a)(6)(v), (a)(6)(vi), and (c) apply in all new uses described in paragraph cases except that § 721.63(a)(2)(ii) does (a)(1)(i) of this section.

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(i) The significant new uses are: (i) The significant new uses are: (A) Protection in the workplace. The (A) Protection in the workplace. The general requirements as specified in general requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), § 721.63 (a) (1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), and (c) apply in all (a)(6)(v), (a)(6)(vi), and (c) apply in all cases except that § 721.63(a)(2)(ii) does cases except that § 721.63(a)(2)(ii) does not apply for reactor sampling oper- not apply for reactor sampling operations where enclosed vented sample ations where enclosed vented sample boxes are used. In addition boxes are used. In addition § 721.63(a)(2)(iv) applies for processing § 721.63(a)(2)(iv) applies for processing of any byproduct generated during of any byproduct generated during manufacturing, processing, or use of manufacturing, processing, or use of the chemical substance which contains the chemical substance which contain residual amounts of the chemical sub- residual amounts of the chemical substance. stance. (B) Hazard communication program. (B) Hazard communication program. Requirements as specified in § 721.72 (a), Requirements as specified in § 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), (b) , (c), (d), (f), (g)(1)(iv), (g)(1)(vii), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), (C) Disposal. Requirements as speci- (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), (C) Disposal. Requirements as speci- (c)(1), and (c)(2). The following addi- fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), tional disposal methods also apply: (c)(1), and (c)(2). The following addi- Chemical destruction or, where nec- tional disposal methods also apply: essary to ensure complete destruction Chemical destruction or, where nec- of the substance, chemical destruction essary to ensure complete destruction and carbon adsorption. of the substance, chemical destruction (D) Release to water. Requirements as and carbon adsorption. specified in § 721.90 (a)(4), (b)(4), and (D) Release to water. Requirements as (c)(4) (concentration set at 10 ppb). specified in § 721.90 (a)(4), (b)(4), and Where primary, secondary, and ter- (c)(4) (concentration set at 0.2 ppb). tiary waste treatment will occur, or Where primary, secondary, and ter- treatment in a lined, self-contained tiary waste treatment will occur, or solar evaporation pond where UV light treatment in a lined, self-contained will degrade the substance, the number solar evaporation pond where UV light of kilograms per day per site is cal- will degrade the substance, the number culated after wastewater treatment. of kilograms per day per site is cal- (ii) Specific requirements. The provi- culated after wastewater treatment. sions of subpart A of this part apply to (ii) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (A) Recordkeeping. The following rec- paragraph. ordkeeping requirements are applicable (A) Recordkeeping. The following rec- to manufacturers, importers, and proc- ordkeeping requirements are applicable essors of this substance: § 721.125 (a) to manufacturers, importers, and proc- through (h), (j), and (k). essors of this substance: § 721.125 (a) (B) Limitations or revocation of certain through (h), (j), and (k). notification requirements. The provisions (B) of § 721.185 apply to this section. Limitations or revocation of certain (2) The chemical substance identified notification requirements. The provisions generically as halogenated alkyl pyri- of § 721.185 apply to this section. dine (PMN P-83–1162) is subject to re- (b) [Reserved] porting under this section for the sig- [56 FR 23771, May 23, 1991. Redesignated at 58 nificant new uses described in para- FR 29947, May 24, 1993, as amended at 58 FR graph (a)(2)(i) of this section. 34204, June 23, 1993; 59 FR 66747, Dec. 28, 1994]

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§ 721.8750 Halogenated substituted essors of this substance: § 721.125 (a) pyridine. through (h), (j), and (k). (2) Limitations or revocation of certain (a) Chemical substances and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generically as halogenated substituted pyri- [56 FR 23769, May 23, 1991. Redesignated at 58 dine (PMN P-86–838) is subject to re- FR 29947, May 24, 1993, as amended at 58 FR porting under this section for the sig- 34204, June 23, 1993; 59 FR 66747, Dec. 28, 1994] nificant new uses described in para- § 721.8775 Substituted pyridines. graph (a)(2) of this section. (2) The significant new uses are: (a) Chemical substances and significant (i) Protection in the workplace. The new uses subject to reporting. (1) The general requirements as specified in chemical substance identified generically as substituted pyridine (PMN P- § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), 84–1219) is subject to reporting under (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), this section for the significant new (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(6)(i), uses described in paragraph (a)(1)(i) of (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), this section. (a)(6)(vi), and (c) apply in all cases ex- (i) The significant new uses are: cept that § 721.63(a)(2)(ii) does not apply (A) Protection in the workplace. The for reactor sampling operations where general requirements as specified in enclosed vented sample boxes are used. § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), In addition § 721.63(a)(2)(iv) applies for (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), processing of any byproduct generated (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), during manufacturing, processing, or (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), use of the chemical substance which (a)(6)(v), (a)(6)(vi), and (c) apply in all contains residual amounts of the chem- cases except that § 721.63(a)(2)(ii) does ical substance. not apply for reactor sampling oper- (ii) Hazard communication program. ations where enclosed vented sample Requirements as specified in § 721.72 (a), boxes are used. In addition (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), § 721.63(a)(2)(iv) applies for processing (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), of any byproduct generated during (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and manufacturing, processing, or use of (g)(5). the chemical substance which contains (iii) Disposal. Requirements as speci- residual amounts of the chemical sub- fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), stance. (c)(1), and (c)(2). The following addi- (B) Hazard communication program. tional disposal methods also apply: Requirements as specified in § 721.72 (a), Chemical destruction or, where nec- (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), essary to ensure complete destruction (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), of the substance, chemical destruction (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). and carbon adsorption. (C) Disposal. Requirements as speci- (iv) Release to water. Requirements as fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), specified in § 721.90 (a)(4), (b)(4), and (c)(1), and (c)(2). The following addi- (c)(4) (concentration set at 1 ppb). tional disposal methods also apply: Where primary, secondary, and ter- Chemical destruction or, where nec- tiary waste treatment will occur, or essary to ensure complete destruction treatment in a lined, self-contained of the substance, chemical destruction solar evaporation pond where UV light and carbon adsorption. will degrade the substance, the number (D) Release to water. Requirements as of kilograms per day per site is cal- specified in § 721.90 (a)(4), (b)(4), and culated after wastewater treatment. (c)(4) (concentration set at 10 ppb). (b) Specific requirements. The provi- Where primary, secondary, and ter- sions of subpart A of this part apply to tiary waste treatment will occur, or this section except as modified by this treatment in a lined, self-contained paragraph. solar evaporation pond where UV light (1) Recordkeeping. The following rec- will degrade the substance, the number ordkeeping requirements are applicable of kilograms per day per site is cal- to manufacturers, importers, and proc- culated after wastewater treatment.

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(ii) Specific requirements. The provi- of kilograms per day per site is cal- sions of subpart A of this part apply to culated after wastewater treatment. this section except as modified by this (ii) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (A) Recordkeeping. The following rec- this section except as modified by this ordkeeping requirements are applicable paragraph. to manufacturers, importers, and proc- (A) Recordkeeping. The following rec- essors of this substance: § 721.125 (a) ordkeeping requirements are applicable through (h), (j), and (k). to manufacturers, importers, and proc- (B) Limitations or revocation of certain essors of this substance: § 721.125 (a) notification requirements. The provisions through (h), (j), and (k). of § 721.185 apply to this section. (B) Limitations or revocation of certain (2) The chemical substances identi- notification requirements. The provisions fied generically as substituted of § 721.185 apply to this section. pyridines (PMNs P-85–236 and P-85–706) (3) The chemical substance identified are subject to reporting under this sec- generically as substituted pyridine tion for the significant new uses de- (PMN P-85–36) is subject to reporting scribed in paragraph (a)(2)(i) of this under this section for the significant section. new uses described in paragraph (a)(3)(i) of this section. (i) The significant new uses are: (i) The significant new uses are: (A) Protection in the workplace. The (A) Protection in the workplace. The general requirements as specified in general requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), and (c) apply in all (a)(6)(v), (a)(6)(vi), and (c) apply in all cases except that § 721.63(a)(2)(ii) does cases except that § 721.63(a)(2)(ii) does not apply for reactor sampling oper- not apply for reactor sampling operations where enclosed vented sample ations where enclosed vented sample boxes are used. In addition boxes are used. In addition § 721.63(a)(2)(iv) applies for processing § 721.63(a)(2)(iv) applies for processing of any byproduct generated during of any byproduct generated during manufacturing, processing, or use of manufacturing, processing, or use of the chemical substance which contains the chemical substance which contain residual amounts of the chemical sub- residual amounts of the chemical substance. stance. (B) Hazard communication program. (B) Hazard communication program. Requirements as specified in § 721.72 (a), Requirements as specified in § 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (C) Disposal. Requirements as speci- (g)(5). fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), (C) Disposal. Requirements as speci- (c)(1), and (c)(2). The following addi- fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), tional disposal methods also apply: (c)(1), and (c)(2). The following addi- Chemical destruction or, where nec- tional disposal methods also apply: essary to ensure complete destruction Chemical destruction or, where nec- of the substance, chemical destruction essary to ensure complete destruction and carbon adsorption. of the substance, chemical destruction (D) Release to water. Requirements as and carbon adsorption. specified in § 721.90 (a)(4), (b)(4), and (D) Release to water. Requirements as (c)(4) (concentration set at 0.2 ppb). specified in § 721.90 (a)(4), (b)(4), and Where primary, secondary, and ter- (c)(4) (concentration set at 10 ppb). tiary waste treatment will occur, or Where primary, secondary, and ter- treatment in a lined, self-contained tiary waste treatment will occur, or solar evaporation pond where UV light treatment in a lined, self-contained will degrade the substance, the number solar evaporation pond where UV light

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will degrade the substance, the number solar evaporation pond where UV light of kilograms per day per site is cal- will degrade the substance, the number culated after wastewater treatment. of kilograms per day per site is cal- (ii) Specific requirements. The provi- culated after wastewater treatment. sions of subpart A of this part apply to (ii) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (A) Recordkeeping. The following rec- paragraph. ordkeeping requirements are applicable (A) Recordkeeping. The following rec- to manufacturers, importers, and proc- ordkeeping requirements are applicable essors of this substance: § 721.125 (a) to manufacturers, importers, and proc- through (h), (j), and (k). essors of this substance: § 721.125 (a) (B) Limitations or revocation of certain through (h), (j), and (k). notification requirements. The provisions (B) Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions (4) The chemical substance identified of § 721.185 apply to this section. generically as substituted pyridine (b) [Reserved] (PMN P-85–1184) is subject to reporting [56 FR 23770, May 23, 1991. Redesignated at 58 under this section for the significant FR 29947, May 24, 1993, as amended at 58 FR new uses described in paragraph 34204, June 23, 1993; 59 FR 66747, Dec. 28, 1994] (a)(4)(i) of this section. (i) The significant new uses are: § 721.8780 Substituted pyridine azo (A) Protection in the workplace. The substituted phenyl. general requirements as specified in (a) Chemical substance and significant § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), new uses subject to reporting. (1) The (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), chemical substances identified generi- (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), cally as substituted pyridine azo sub- (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), stituted phenyl (PMNs P-96–767 and P- (a)(6)(v), (a)(6)(vi), and (c) apply in all 96–773) are subject to reporting under cases except that § 721.63(a)(2)(ii) does this section for the significant new not apply for reactor sampling oper- uses described in paragraph (a)(2) of ations where enclosed vented sample this section. boxes are used. In addition (2) The significant new uses are: § 721.63(a)(2)(iv) applies for processing (i) Industrial, commercial, and con- of any byproduct generated during sumer activities. Requirements as speci- manufacturing, processing, or use of fied in § 721.80(f). the chemical substance which contains (ii) [Reserved] residual amounts of the chemical sub- (b) Specific requirements. The provi- stance. sions of subpart A of this part apply to (B) Hazard communication program. this section except as modified by this Requirements as specified in § 721.72 (a), paragraph. (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (1) Recordkeeping. Recordkeeping re- (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), quirements as specified in § 721.125 (a) (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and and (i) are applicable to manufacturers (g)(5). and importers of this substance. (C) Disposal. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), notification requirements. The provisions (c)(1), and (c)(2). The following addi- of § 721.185 apply to this section. tional disposal methods also apply: [63 FR 3435, Jan. 22, 1998] Chemical destruction or, where necessary to ensure complete destruction § 721.8825 Substituted methylpyridine of the substance, chemical destruction and substituted 2-phenoxypyridine. and carbon adsorption. (a) Chemical substances and significant (D) Release to water. Requirements as new uses subject to reporting. (1) The fol- specified in § 721.90 (a)(4), (b)(4), and lowing chemical substances, referred to (c)(4) (concentration set at 1.3 ppb). by their PMN numbers and generic Where primary, secondary, and ter- chemical names, are subject to report- tiary waste treatment will occur or ing under this section for the signifi- treatment in a lined, self-contained cant new uses described in paragraphs

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(a)(2) and (3) of this section: Sub- kidney, and nervous system toxicity stituted methylpyridine (P-83–24, P-83– unless the specified protective equip- 49, and P-83–272) and substituted 2- ment is used. phenoxypyridine (P-83–23 and P-83–75). (3) The significant new uses for P-83– (2) The significant new uses for P-83– 23, P-83–24, and P-83–75 are manufacture 49 and P-83–272 are manufacture or or processing without: processing without: (i) Requiring the use of the following (i) Requiring use of the following per- personal protective equipment for personal protective equipment for persons sons involved in any operation where involved in any operation where der- dermal contact may occur: mal contact and/or inhalation of the (A) Chemical goggles. substances may occur, and where local (B) Chemical worker gloves and exhaust ventilation is present at the aprons, or other equivalent personal site of the operation: protective clothing determined to be (A) Chemical cartridge respirator, impervious to the particular substance approved by the National Institute for in its conditions of use. (Equipment Occupational Safety and Health for may be determined to be impervious ei- protection from organic vapors, and ther by testing under the conditions of used and fitted according to 29 CFR use, including the duration of exposure, 1910.134 and 30 CFR part 11. or by evaluating the specifications sup- (B) Chemical worker gloves and plied by the supplier of the equipment.) aprons or other equivalent personal (ii) Notifying in writing, each em- protective clothing determined to be ployee required to use protective impervious to the particular substance equipment that these chemical sub- in its conditions of use. (Equipment stances may present a hazard of liver, may be determined to be impervious ei- kidney, and nervous system toxicity ther by testing under the conditions of unless the specified protective equip- use, including the duration of exposure, ment is used. or by evaluating the specifications sup- (b) Specific requirements. In addition plied by the supplier of the equipment.) to the general provisions of subpart A (ii) Requiring use of the following of this part, the following specific re- personal protective equipment for per- quirements apply. sons involved in and in the immediate (1) Recordkeeping. In addition to the area of any operation where dermal requirements of § 721.17, manufacturers, contact and/or inhalation of the sub- importers, and processors of the chem- stance may occur, and where local ex- ical substances identified in paragraph haust ventilation is not present at the (a) of this section must maintain the site of the operation: following records for five years from (A) Full facepiece, positive pressure the date of their creation: air-supplied respirator, approved by the (i) The names of persons required to Bureau of Mines, Department of the In- wear protective clothing and/or equip- terior or by the National Institute of ment. Occupational Safety and Health fitted (ii) Records of respirator fit tests for according to procedures established at each person required to wear a res- 29 CFR 1910.134. pirator. (B) Chemical worker gloves and (iii) The names and addresses of per- aprons, or other equivalent personal sons to whom any of these substances protective clothing determined to be are sold or transferred and the date of impervious to the particular substance such sale or transfer. in its conditions of use. (Equipment (2) [Reserved] may be determined to be impervious ei- [49 FR 50400, Dec. 28, 1984. Redesignated at 53 ther by testing under the conditions of FR 2845, Feb. 2, 1988. Further redesignated at use, including the duration of exposure, 58 FR 29947, May 24, 1993, as amended at 58 or by evaluating the specifications sup- FR 34204, June 23, 1993] plied by the supplier of the equipment.) (iii) Notifying in writing, each em- § 721.8850 Disubstituted halogenated ployee required to use protective pyridinol. equipment that these chemical sub- (a) Chemical substances and significant stances may present a hazard of liver, new uses subject to reporting. (1) The

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chemical substance identified generi- (2) Limitations or revocation of certain cally as disubstituted halogenated notification requirements. The provisions pyridinol (PMN P-88–1274) is subject to of § 721.185 apply to this section. reporting under this section for the sig- [56 FR 23771, May 23, 1991. Redesignated at 58 nificant new uses described in para- FR 29947, May 24, 1993, as amended at 58 FR graph (a)(2) of this section. 34204, June 23, 1993; 59 FR 66748, Dec. 28, 1994] (2) The significant new uses are: (i) Protection in the workplace. The § 721.8875 Substituted halo- general requirements as specified in genated pyridinol. § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a) Chemical substances and significant (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), new uses subject to reporting. (1) The (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), chemical substance identified generi- (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), cally as substituted halogenated (a)(6)(v), (a)(6)(vi), and (c) apply in all pyridinol (PMN P-88–1273) is subject to cases except that § 721.63(a)(2)(ii) does reporting under this section for the sig- not apply for reactor sampling oper- nificant new uses described in para- ations where enclosed vented sample graph (a)(2) of this section. boxes are used. In addition (2) The significant new uses are: § 721.63(a)(2)(iv) applies for processing (i) Protection in the workplace. The of any byproduct generated during general requirements as specified in manufacturing, processing, or use of § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), the chemical substance which contains (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), residual amounts of the chemical sub- (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), stance. (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), and (c) apply in all (ii) Hazard communication program. cases except that § 721.63(a)(2)(ii) does Requirements as specified in § 721.72 (a), not apply for reactor sampling oper- (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), ations where enclosed vented sample (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), boxes are used. In addition (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). § 721.63(a)(2)(iv) applies for processing (iii) Disposal. Requirements as speci- of any byproduct generated during fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), manufacturing, processing, or use of (c)(1), and (c)(2). The following addi- the chemical substance which contains tional disposal methods also apply: residual amounts of the chemical sub- Chemical destruction or, where nec- stance. essary to ensure complete destruction (ii) Hazard communication program. of the substance, chemical destruction Requirements as specified in § 721.72 (a), and carbon adsorption. (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (iv) Release to water. Requirements as (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), specified in § 721.90 (a)(4), (b)(4), and (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). (c)(4) (concentration set at 44 ppb). (iii) Disposal. Requirements as speci- Where primary, secondary, and ter- fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), tiary waste treatment will occur, or (c)(1), and (c)(2). The following addi- treatment in a lined, self-contained tional disposal methods also apply: solar evaporation pond where UV light Chemical destruction or, where nec- will degrade the substance, the number essary to ensure complete destruction of kilograms per day per site is cal- of the substance, chemical destruction culated after wastewater treatment. and carbon adsorption. (b) Specific requirements. The provi- (iv) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(4), (b)(4), and this section except as modified by this (c)(4) (concentration set at 44 ppb). Where primary, secondary, and ter- paragraph. tiary waste treatment will occur, or (1) Recordkeeping. The following rec- treatment in a lined, self-contained ordkeeping requirements are applicable solar evaporation pond where UV light to manufacturers, importers, and proc- will degrade the substance, the number essors of this substance: § 721.125 (a) of kilograms per day per site is cal- through (h), (j), and (k). culated after wastewater treatment.

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(b) Specific requirements. The provi- (iv) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(4), (b)(4), and this section except as modified by this (c)(4) (concentration set at 44 ppb). paragraph. Where primary, secondary, and ter- (1) Recordkeeping. The following rec- tiary waste treatment will occur, or ordkeeping requirements are applicable treatment in a lined, self-contained to manufacturers, importers, and proc- solar evaporation pond where UV light essors of this substance: § 721.125 (a) will degrade the substance, the number through (h), (j), and (k). of kilograms per day per site is cal- (2) Limitations or revocation of certain culated after wastewater treatment. notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to [56 FR 23772, May 23, 1991. Redesignated at 58 this section except as modified by this FR 29947, May 24, 1993, as amended at 58 FR paragraph. 34204, June 23, 1993; 59 FR 66748, Dec. 28, 1994] (1) Recordkeeping. The following recordkeeping requirements are applicable § 721.8900 Substituted halo- to manufacturers, importers, and proc- genated pyridinol, alkali salt. essors of this substance: § 721.125 (a) (a) Chemical substances and significant through (h), (j), and (k). new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substances identified generi- notification requirements. The provisions cally as substituted halogenated of § 721.185 apply to this section. pyridinols, alkali salts (PMNs P-88–1271 and P-88–1272) are subject to reporting [56 FR 23772, May 23, 1991. Redesignated at 58 under this section for the significant FR 29947, May 24, 1993, as amended at 58 FR new uses described in paragraph (a)(2) 34204, June 23, 1993; 59 FR 66748, Dec. 28, 1994] of this section. (2) The significant new uses are: § 721.8920 4,6-Disubstituted pyrimidine (generic). (i) Protection in the workplace. The general requirements as specified in (a) Chemical substance and significant § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), new uses subject to reporting. (1) The (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), chemical substance identified generi- (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), cally as 4,6-disubstituted pyrimidine (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (PMN P-99–1366) is subject to reporting (a)(6)(v), (a)(6)(vi), and (c) apply in all under this section for the significant cases except that § 721.63(a)(2)(ii) does new use described in paragraph (a)(2) of not apply for reactor sampling oper- this section. ations where enclosed vented sample (2) The significant new uses are: boxes are used. In addition (i) Industrial, commercial, and con- § 721.63(a)(2)(iv) applies for processing sumer activities. Requirements as speci- of any byproduct generated during fied in § 721.80(f). manufacturing, processing, or use of (ii) [Reserved] the chemical substance which contains residual amounts of the chemical sub- (b) Specific requirements. The provi- stance. sions of subpart A of this part apply to (ii) Hazard communication program. this section except as modified by this Requirements as specified in § 721.72 (a), paragraph. (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (1) Recordkeeping. Recordkeeping re- (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), quirements as specified in § 721.125 (a), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). (b), (c), and (i) are applicable to manu- (iii) Disposal. Requirements as speci- facturers, importers, and processors of fied in § 721.85 (a)(1), (a)(2), (b)(1), (b)(2), this substance. (c)(1), and (c)(2). The following addi- (2) Limitations or revocation of certain tional disposal methods also apply: notification requirements. The provisions Chemical destruction or, where nec- of § 721.185 apply to this section. essary to ensure complete destruction of the substance, chemical destruction [68 FR 15088, Mar. 28, 2003] and carbon adsorption.

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§ 721.8940 Chromate(3-), bis[3-[[6- nificant new use described in paragraph amino-1,4-dihydro-2-[[[4-[(2-hy- (a)(2) of this section. droxy-1-naphthalenyl)azo] (2) The significant new uses are: phenyl]sulfonyl] amino]-4-(oxo- (i) Industrial, commercial, and con- .kappa.O)-5- pyrimidinyl]azo- .kappaN1] -4-hydroxy-.kappa.O)-5- sumer activities. Requirements as speci- nitrobenzenesulfonato(3-)]-, tri- fied in § 721.80 (v)(1), (w)(1), and (x)(1). sodium. (ii) [Reserved] (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified as chro- this section except as modified by this mate(3-), bis[3-[[6-amino-1,4-dihydro-2- paragraph. [[[4-[(2-hydroxy-1-naphthalenyl)azo] (1) Recordkeeping. Recordkeeping re- phenyl] sulfonyl]amino]-4-(oxo- quirements as specified in § 721.125(a), .kappa.O)-5-pyrimidinyl]azo-.kappaN1] (b), (c), and (i) are applicable to manu- -4-hydroxy-.kappa.O)-5- facturers, importers, and processors of nitrobenzenesulfonato(3-)]-, trisodium this chemical substance. (PMN P-01–459; CAS No. 178452–72–7) is (2) Limitations or revocation of certain subject to reporting under this section notification requirements. The provisions for the significant new use described in of § 721.185 apply to this section. paragraph (a)(2) of this section. (2) The significant new uses are: [68 FR 70182, Dec. 17, 2003] (i) Industrial, commercial, and consumer activities. Requirements as speci- § 721.8965 1H-Pyrole-2, 5-dione, 1-(2,4,6- fied in § 721.80 (v)(1), (w)(1), and (x)(1). tribromophenyl)-. (ii) [Reserved] (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified as 1H- this section except as modified by this pyrole-2, 5-dione, 1-(2,4,6- paragraph. tribromophenyl)-, (PMN No. P-90–159) (1) Recordkeeping. Recordkeeping re- is subject to reporting under this sec- quirements as specified in § 721.125(a), tion for the significant new uses de- (b), (c), and (i) are applicable to manu- scribed in paragraph (a)(2) of this sec- facturers, importers, and processors of tion. this chemical substance. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Protection in the workplace. Re- notification requirements. The provisions quirements as specified in § 721.63 of § 721.185 apply to this section. (a)(2)(iii) for employees likely to have [68 FR 70182, Dec. 17, 2003] ocular exposure, (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(6)(i), (b) (con- § 721.8950 Chromate(3-), bis[3-[[6- centration set at 0.1 percent by weight amino-1,4-dihydro-2-[[[4-[(2-hy- or volume), and (c). droxy-1-naphthalenyl)azo] phenyl]sulfonyl]amino]-4-(oxo- (ii) Hazard communication program. .kappa.O)-5-pyrimidinyl]azo- Requirements as specified in § 721.72 (a), .kappaN1]-4-hydroxy-.kappa.O)-5- (b), (c), (d), (e) concentration set at 0.1 nitrobenzenesulfonato(3-)]-, sodium percent by weight or volume, (f), triethanolamine salts. (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), (a) Chemical substance and significant (g)(1)(vii), (g)(1)(ix) (corrosion to the new uses subject to reporting. (1) The eyes), (g)(2)(iii), (g)(2)(iv)( use chemical chemical substance identified as chro- goggles), (g)(3)(ii), (g)(4)(i), (g)(4)(iii) mate(3-), bis[3-[[6-amino-1,4-dihydro-2- (except the dewatering step during po- [[[4-[(2-hydroxy-1-naphthalenyl)azo] lymerization of acrylonitrile/buta- phenyl]sulfonyl]amino]-4-(oxo- diene/styrene), and (g)(5). .kappa.O)-5-pyrimidinyl]azo-.kappaN1] (iii) Industrial, commercial, and con- -4-hydroxy-.kappa.O)-5- sumer activities. Requirements as speci- nitrobenzenesulfonato(3-)]-, sodium tri- fied in § 721.80 (a), (c), (f), (k) (any use ethanolamine salts. (PMN P-01–460; in a system other than as flame retard- CAS No. 327177–98–0) is subject to re- ant in styrenic, polyolefin elastomer, porting under this section for the sig- and thermoset systems), (l), and (q).

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(iv) Disposal. Requirements as speci- chemical substance identified as 2- fied in § 721.85 (b)(1) (by industrial in- pyrrolidinone, 1,1′-(2-methyl-1,5- cinerator), (b)(2), (c)(1), and (c)(2). Dis- pentanediyl)bis- (PMN P-93–761; CAS pose of the PMN substance by indus- No. 146453–62–5) is subject to reporting trial incinerator or landfill. under this section for the significant (v) Release to water. Requirements as new uses described in paragraph (a)(2) specified in § 721.90 (b)(1) and (c)(1). Sec- of this section. tion 721.90 (c)(1) does not apply to re- (2) The significant new uses are: leases of the PMN substance during the (i) Protection in the workplace. Re- dewatering step of the polymerization quirements as specified in § 721.63 (a)(1), reactions from use. (a)(2)(i) (There must be no permeation (b) Specific requirements. The provi- of the PMN substance greater than 0.08 sions of subpart A of this part apply to grams (g)/minutes (min) centimeter this section except as modified by this (cm2) after 8 hours of testing in accord- paragraph. ance with the most current version of (1) Recordkeeping. Recordkeeping re- the American Society for Testing and quirements as specified in § 721.125 (a) Materials (ASTM) F739 ‘‘Standard Test through (d), and (f) through (k) are ap- Method for Resistance of Protective plicable to manufacturers, importers, Clothing Materials to Permeation by and processors of this substance. Liquids or Gases.’’ The results of all (2) Limitations or revocation of certain glove permeation testing must be re- notification requirements. The provisions ported in accordance with the most of § 721.185 apply to this significant new current version of (ASTM) F1194 use rule. ‘‘Guide for Documenting the Results of (3) Determining whether a specific use is Chemical Permeation Testing of Pro- subject to this section. The provisions of tective Clothing Materials.’’ Manufac- § 721.1725(b)(1) apply to this section. turers, importers, and processors must submit such glove test data to the [58 FR 32240, June 8, 1993, as amended at 58 FR 29946, May 24, 1993] Agency and must receive written Agen- cy approval for each type of glove test- § 721.9000 N-Nitrosopyrrolidine. ed prior to use of such gloves. The following gloves have been tested in ac- (a) Chemical substance and significant cordance with the ASTM F739 method new use subject to reporting. (1) The and found to satisfy the requirements chemical substance N- for use by EPA: Ansell Edmond/8–352/ nitrosopyrrolidine (CAS No. 930–55–2) is Neoprene rubber, 0.097 cm thick. Gloves subject to reporting under this section may not be used for a time period for the significant new use described in longer than they are actually tested paragraph (a)(2) of this section. and must be replaced at the end of each (2) The significant new use is: Manu- work shift), (a)(2)(ii), (a)(2)(iii), (a)(3), facture, import, or processing of 10,000 (b) (concentration set at 1.0 percent), pounds or more per year per facility for and (c). any use. (ii) Hazard communication program. (b) Specific requirements. The provi- Requirements as specified in § 721.72 (a), sions of subpart A of this part apply to (b), (c), (d), (e) (concentration set at 1.0 this section except as modified by this percent), (f), (g)(l)(iii), (g)(l)(iv), paragraph. (g)(2)(i), (g)(2)(iii), (g)(2)(v), and (g)(5). (1) Recordkeeping. The following rec- The label and MSDS as required by this ordkeeping requirements are applicable paragraph shall also include the fol- to manufacturers, importers, and proc- lowing statement: This substance is ex- essors of this substance, as specified in pected to enhance the absorption of § 721.125 (a), (b), and (c). other chemicals into skin or other ma- (2) [Reserved] terials. [58 FR 63517, Dec. 1, 1993] (iii) Industrial, commercial, and consumer activities. Requirements as speci- § 721.9005 2-Pyrrolidinone, 1,1′-(2- fied in § 721.80 (o), (q), and (k) (use other methyl-1,5-pentanediyl)bis-. than as a heat transfer fluid). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to

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this section except as modified by this (i) Industrial, commercial, and con- paragraph. sumer activities. Requirements as speci- (1) Recordkeeping. Recordkeeping re- fied in § 721.80(f). quirements as specified in § 721.125 (a), (ii) Release to water. Requirements as (b), (c), (d), (e), (f), (g), (h), and (i) are specified in § 721.90 (a)(1), (b)(1), and applicable to manufacturers, import- (c)(1). ers, and processors of this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. (3) Determining whether a specific use is (1) Recordkeeping. Recordkeeping re- subject to this section. The provisions of quirements as specified in § 721.125 (a), § 721.1725(b)(1) apply to this section. (b), (c), (i), and (k) are applicable to [63 FR 3435, Jan. 22, 1998] manufacturers, importers, and processors of this substance. § 721.9010 2-pyrrolidone, 1-ethenyl-3- (2) Limitations or revocation of certain ethylidene-, (E)-. notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this significant new new uses subject to reporting. (1) The use rule. chemical substance identified as 2- [58 FR 32241, June 8, 1993] pyrrolidone, 1-ethenyl-3-ethylidene-, (E)- (PMN P-96–1536; CAS No. 153954–47– § 721.9078 6-Methoxy-1H- 3) is subject to reporting under this benz[de]isoquinoline-2 [3H]-dione section for the significant new uses de- derivative (generic). scribed in paragraph (a)(2) of this sec- (a) Chemical substance and significant tion. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified generi- (i) Protection in the workplace. Re- cally as 6-methoxy-1H- quirements as specified in § 721.63 benz[de]isoquinoline-2 [3H]-dione deriv- (a)(2)(i) and (a)(3). ative (PMN P-00–1205) is subject to re- (ii) [Reserved] porting under this section for the sig- (b) Specific requirements. The provi- nificant new use described in paragraph sions of subpart A of this part apply to (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Release to water. Requirements as (1) Recordkeeping. Recordkeeping re- specified in § 721.90(a)(4), (b)(4), and quirements as specified in § 721.125 (a), (c)(4) (N=30). (b), (c), (d), and (e) are applicable to manufacturers, importers, and proc- (ii) [Reserved] essors of this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. (1) Recordkeeping. Recordkeeping re- [63 FR 3436, Jan. 22, 1998] quirements as specified in § 721.125(a), (b), (c), and (k) are applicable to manu- § 721.9075 Quaternary ammonium salt facturers, importers, and processors of of fluorinated alkylaryl amide. this chemical substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance identified generi- of § 721.185 apply to this section. cally as quaternary ammonium salt of fluorinated alkylaryl amide (PMN No. [68 FR 70182, Dec. 17, 2003] P-92–688) is subject to reporting under this section for the significant new § 721.9079 Dihydro quinacridone deriv- uses described in paragraph (a)(2) of ative (generic). this section. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The

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chemical substance identified generi- § 721.9100 Substituted quinoline. cally as dihydro quinacridone deriva- (a) Chemical substance and significant tive (PMN P-01–397) is subject to renew uses subject to reporting. (1) The porting under this section for the sig- chemical substance identified generi- nificant new use described in paragraph cally as substituted quinoline (PMN P- (a)(2) of this section. 93–1183) is subject to reporting under (2) The significant new uses are: this section for the significant new (i) Industrial, commercial, and con- uses described in paragraph (a)(2) of sumer activities. Requirements as speci- this section. fied in § 721.80(s) (1,000 kg). (2) The significant new uses are: (ii) Release to water. Requirements as (i) Industrial, commercial, and con- specified § 721.90(a)(4), (b)(4), and (c)(4) sumer activities. Requirements as speci- (N=2). fied in § 721.80(c). (b) Specific requirements. The provi- (ii) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(1), (b)(1), and this section except as modified by this (c)(1). paragraph. (b) Specific requirements. The provisions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125(a), paragraph. (b), (c), (i), and (k) are applicable to (1) Recordkeeping. Recordkeeping re- manufacturers, importers, and proc- quirements as specified in § 721.125 (a), essors of this chemical substance. (b), (c), (i), and (k) are applicable to (2) Limitations or revocation of certain manufacturers, importers, and proc- notification requirements. The provisions essors of this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain [68 FR 70182, Dec. 17, 2003] notification requirements. The provisions of § 721.185 apply to this section. § 721.9080 Nitro methyl quinoline. [59 FR 27485, May 27, 1994] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.9220 Reaction products of secondary alkyl amines with a sub- chemical substance identified generi- stituted benzenesulfonic acid and cally as nitro methyl quinoline (PMN sulfuric acid (generic name). P-96–1319) is subject to reporting under (a) Chemical substances and significant this section for the significant new new uses subject to reporting. (1) The uses described in paragraph (a)(2) of chemical substances identified generi- this section. cally as reaction products of secondary (2) The significant new uses are: alkyl amines with a substituted (i) Protection in the workplace. Re- benzenesulfonic acid and sulfuric acid quirements as specified in § 721.63 (a)(4), (PMNs P-89–703, P-89–755, and P-89–756) (a)(5)(ii), (a)(5)(iv), (a)(5)(v), and are subject to reporting under this sec- (a)(6)(i). tion for significant new uses described (ii) Disposal. Requirements as speci- in paragraph (a)(2) of this section. fied in § 721.85 (a)(1), (b)(1), and (c)(1). (2) The significant new uses are: (b) Specific requirements. The provi- (i) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Uses as specified in this section except as modified by this § 721.80(q). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), (d), and (j) are applicable to this section except as modified by this manufacturers, importers, and proc- paragraph. essors of this substance. (1) Recordkeeping. The following recordkeeping requirements are applicable (2) Limitations or revocation of certain to manufacturers, importers, and proc- notification requirements. The provisions essors of these substances: Record- of § 721.185 apply to this section. keeping requirements specified in [63 FR 3436, Jan. 22, 1998] § 721.125 (a), (b), (c), and (i).

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(2) Limitations or revocation of certain anhydride and glycerol and glycol notification requirements. The provisions (PMN P-96–1233) is subject to reporting of § 721.185 apply to this section. under this section for the significant (3) Determining whether a specific use is new uses described in paragraph (a)(2) subject to this section. The provisions of of this section. § 721.1725(b)(1) apply to this section. (2) The significant new uses are: (i) Industrial, commercial, and con- [55 FR 17381, Apr. 24, 1990. Redesignated and amended at 58 FR 29946, May 24, 1993; 58 FR sumer activities. Requirements as speci- 34204, June 23, 1993] fied in § 721.80 (v)(1), (w)(1), (x)(1) and (y)(2). § 721.9265 Reaction product of (ii) Release to water. Requirements as dichlorobenzidine and substituted specified in § 721.90 (a)(1), (b)(1), and alkylamide. (c)(1). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as a reaction product of paragraph. dichlorobenzidine and substituted (1) Recordkeeping. Recordkeeping re- alkylamide (PMN P-95–1282) is subject quirements as specified in § 721.125 (a), to reporting under this section for the (b), (c), (i), and (k) are applicable to significant new uses described in para- manufacturers, importers, and proc- graph (a)(2) of this section. essors of this substance. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Hazard communication program. Re- notification requirements. The provisions quirements as specified in § 721.72 (a), of § 721.185 apply to this section. (b), (c), (d), (e), (f), and (g)(5). The label [63 FR 3436, Jan. 22, 1998] and MSDS as required by this paragraph shall also include the following § 721.9280 Reaction product of statements: At temperatures above 200 ethoxylated fatty acid oils and a °C, this substance decomposes to phenolic pentaerythritol tetraester. produce a suspect human carcinogen, (a) Chemical substance and significant 3′,3′ dichlorobenzidine. Do not heat new uses subject to reporting. (1) The above 200 °C or 392 °F. chemical substance identified generi- (ii) Industrial, commercial, and con- cally as a reaction product of sumer activities. Requirements as speci- ethoxylated fatty acid oils and a phe- fied in § 721.80(f) and processing or use nolic pentaerythritol tetraester (PMN of the PMN substance at temperatures P-92–63) is subject to reporting under above 200 °C. this section for the significant new (b) Specific requirements. The provi- uses described in paragraph (a)(2) of sions of subpart A of this part apply to this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Hazard communication program. A (1) Recordkeeping. Recordkeeping re- significant new use of this substance is quirements as specified in § 721.125 (a), any manner or method of manufacture, (b), (c), (f), (g), (h), and (i) are applica- import, or processing associated with ble to manufacturers, importers, and any use of this substance without pro- processors of this substance. viding risk notification as follows: (2) Limitations or revocation of certain (A) If as a result of the test data re- notification requirements. The provisions quired under the section 5(e) consent of § 721.185 apply to this section. order for this substance, the employer [63 FR 3436, Jan. 22, 1998] becomes aware that this substance may present a risk of injury to human § 721.9270 Reaction product of epoxy health, the employer must incorporate with anhydride and glycerol and this new information, and any informa- glycol. tion on methods for protecting against (a) Chemical substance and significant such risk, into an MSDS as described new uses subject to reporting. (1) The in § 721.72(c) within 90 days from the chemical substance identified generi- time the employer becomes aware of cally as reaction product of epoxy with the new information. If this substance

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is not being manufactured, imported, facturers, importers, and processors of processed, or used in the employer’s this substance. workplace, the employer must add the (2) Limitations or revocation of certain new information to an MSDS before notification requirements. The provisions the substance is reintroduced into the of § 721.185 apply to this section. workplace. [63 FR 3436, Jan. 22, 1998] (B) The employer must ensure that persons who have received, or will re- § 721.9300 Reaction products of sub- ceive, this substance from the em- stituted hydroxyalkanes and ployer are provided an MSDS as de- polyalkylpolyisocyanatocarbomono- scribed in § 721.72(c) containing the in- cycle. formation required under paragraph (a) Chemical substance and significant (a)(2)(i)(A) of this section within 90 new uses subject to reporting. (1) The days from the time the employer be- chemical substance identified generi- comes aware of the new information. cally as reaction products of sub- (ii) Industrial, commercial, and con- stituted hydroxyalkanes and polyal- sumer activities. Requirements as speci- kylpolyisocyanatocarbomonocycle fied in § 721.80(q). (PMN P-91–75) is subject to reporting (b) Specific requirements. The provi- under this section for the significant sions of subpart A of this part apply to new uses described in paragraph (a)(2) this section except as modified by this of this section. paragraph. (2) The significant new uses are: (1) Recordkeeping requirements. Re- (i) Hazard communication program. A quirements as specified in § 721.125 (a), significant new use of this substance is (h), and (i) are applicable to manufac- any manner or method of manufacture, turers, importers, and processors of import, or processing associated with this substance. any use of this substance without pro- (2) Limitations or revocation of certain viding risk notification as follows: notification requirements. The provisions (A) If as a result of the test data re- of § 721.185 apply to this section. quired under the section 5(e) consent (3) Determining whether a specific use is order for this substance, the employer subject to this section. The provisions of becomes aware that this substance § 721.1725(b)(1) apply to this section. may present a risk of injury to human [57 FR 44072, Sept. 23, 1992, as amended at 58 health, the employer must incorporate FR 29946, May 24, 1993; 58 FR 34204, June 23, this new information, and any informa- 1993] tion on methods for protecting against such risk, into an MSDS as described § 721.9285 Reaction products of for- in § 721.72(c) within 90 days from the malin (37%) with amine C12. time the employer becomes aware of (a) Chemical substance and significant the new information. If this substance new uses subject to reporting. (1) The is not being manufactured, imported, chemical substance identified generi- processed, or used in the employer’s cally as reaction products of formalin workplace, the employer must add the (37%) with amine C12 (PMN P-95–535) is new information to an MSDS before subject to reporting under this section the substance is reintroduced into the for the significant new uses described workplace. in paragraph (a)(2) of this section. (B) The employer must ensure that (2) The significant new uses are: persons who will receive this substance (i) Release to water. Requirements as from the employer are provided an specified in § 721.90 (a)(1), (b)(1), and MSDS as described in § 721.72(c) con- (c)(1). taining the information required under (ii) [Reserved] paragraph (a)(2)(i)(A) of this section (b) Specific requirements. The provi- within 90 days from the time the em- sions of subpart A of this part apply to ployer becomes aware of the new infor- this section except as modified by this mation. paragraph. (ii) Industrial, commercial, and con- (1) Recordkeeping. Recordkeeping re- sumer activities. Requirements as speci- quirements as specified in § 721.125 (a), fied in § 721.80(p) (volume set at 433,000 (b), (c), and (k) are applicable to manu- kg).

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(b) Specific requirements. The provi- years from the date the employer be- sions of subpart A of this part apply to comes aware of the new information this section except as modified by this described in section (a)(2)(i)(A) of this paragraph. subparagraph, are provided an MSDS (1) Recordkeeping requirements. Re- as described in § 721.72(c) containing the quirements as specified in § 721.125 (a), information required under paragraph (h), and (i) are applicable to manufac- (a)(2)(i)(A) of this section within 90 turers, importers, and processors of days from the time the employer be- this substance. comes aware of the new information. (2) Limitations or revocation of certain (ii) Industrial, commercial, and con- notification requirements. The provisions sumer activities. Requirements as speci- of § 721.185 apply to this section. fied in § 721.80(q). (b) Specific requirements. The provi- [57 FR 44073, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993] sions of subpart A of this part apply to this section except as modified by this § 721.9400 Reaction product of phe- paragraph. nolic pentaerythritol tetraesters (1) Recordkeeping requirements. Re- with fatty acid esters and oils, and quirements as specified in § 721.125 (a), glyceride triesters. (h), and (i) are applicable to manufac- (a) Chemical substances and significant turers, importers, and processors of new uses subject to reporting. (1) The this substance. chemical substances identified generi- (2) Limitations or revocation of certain cally as Reaction product of phenolic notification requirements. The provisions pentaerythritol tetraesters with fatty of § 721.185 apply to this section. acid esters and oils, and glyceride (3) Determining whether a specific use is triesters (PMNs P-91–1231, –1232, –1233, subject to this section. The provisions of –1234, and –1235) are subject to report- § 721.575(b)(1) apply to this section. ing under this section for the signifi- [57 FR 44073, Sept. 23, 1992, as amended at 58 cant new uses described in paragraph FR 34204, June 23, 1993] (a)(2) of this section. (2) The significant new uses are: § 721.9460 Tall oil fatty acids, reaction (i) Hazard communication program. A products with polyamines, alkyl significant new use of this substance is substituted. any manner or method of manufacture, (a) Chemical substance and significant import, or processing associated with new uses subject to reporting. (1) The any use of this substance without pro- chemical substance identified generi- viding risk notification as follows: cally as tall oil fatty acids, reaction (A) If as a result of the test data re- products with polyamines, alkyl sub- quired under the section 5(e) consent stituted (PMN P-91–225) is subject to order for this substance, the employer reporting under this section for the sig- becomes aware that this substance nificant new uses described in para- may present a risk of injury to human graph (a)(2) of this section. health, the employer must incorporate (2) The significant new uses are: this new information, and any informa- (i) Hazard communication program. Re- tion on methods for protectintg quirements as specified in § 721.72 (a), against such risk, into an MSDS as de- (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), scribed in § 721.72(c) within 90 days from (g)(4)(iii), and (g)(5). the time the employer becomes aware (ii) Industrial, commercial, and con- of the new information. If this sub- sumer activities. Requirements as speci- stance is not being manufactured, im- fied in § 721.80(q) and any use in a man- ported, processed, or used in the em- ner that will result in overspray over ployer’s workplace, the employer must or into waters of the United States. add the new information to an MSDS (iii) Release to water. Requirements as before the substance is reintroduced specified in § 721.90 (a)(1), (b)(1), (c)(1), into the workplace. or use in any manner that will result (B) The employer must ensure that in overspray over or into waters of the persons who will receive this sub- United States. stance, or who have received this sub- (b) Specific requirements. The provi- stance from the employer within 5 sions of subpart A of this part apply to

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this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping requirements. Re- this section except as modified by this quirements as specified in § 721.125 (a), paragraph. (b), (c), and (f) through (k) are applica- (1) Recordkeeping. Recordkeeping re- ble to manufacturers, importers, and quirements as specified in § 721.125 (a), processors of this substance. (b), (c), and (k) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain (3) Determining whether a specific use is notification requirements. The provisions subject to this section. The provisions of of § 721.185 apply to this significant new § 721.1725(b)(1) apply to this section. use rule. [57 FR 44074, Sept. 23, 1992, as amended at 58 [55 FR 39905, Sept. 28, 1990. Redesignated and FR 29946, May 24, 1993; 58 FR 34204, June 23, amended at 58 FR 29946, 29947, May 24, 1993; 58 1993] FR 34204, June 23, 1993; 67 FR 12885, Mar. 20, 2002] § 721.9470 Reserpine. (a) Chemical substance and significant § 721.9484 Dimer acid/rosin new use subject to reporting. (1) The amidoamine reaction product (generic). chemical substance reserpine (CAS No. 50–555) is subject to reporting under (a) Chemical substance and significant this section for the significant new use new uses subject to reporting. (1) The described in paragraph (a)(2) of this chemical substance identified generi- section. cally as Dimer acid/rosin amidoamine (2) The significant new use is: Manu- reaction product (PMN P-99–0143) is facture, import, or processing of 10,000 subject to reporting under this section pounds or more per year per facility for for the significant new use described in any use. paragraph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified in § 721.90 (a)(1), (b)(1), and paragraph. (c)(1). (1) Recordkeeping. The following rec- (ii) [Reserved] ordkeeping requirements are applicable (b) Specific requirements. The provi- to manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance, as specified in this section except as modified by this § 721.125 (a), (b), and (c). paragraph. (2) [Reserved] (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), [58 FR 63517, Dec. 1, 1993] (b), (c), and (k) are applicable to manu- § 721.9480 Resorcinol, formaldehyde facturers, importers, and processors of substituted carbomonocycle resin this substance. (generic). (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generi- [65 FR 81403, Dec. 26, 2000] cally as resorcinol, formaldehyde substituted carbomonocycle resin (PMN P- § 721.9485 Dimer acid/polymerized 89–769) is subject to reporting under rosin amidoamine reaction product this section for the significant new (generic). uses described in paragraph (a)(2) of (a) Chemical substance and significant this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified generi- (i) Release to water. Requirements as cally as Dimer acid/polymerized rosin specified in § 721.90 (a)(1), (b)(1), and amidoamine reaction product (PMN P- (c)(1). 99–0144) is subject to reporting under (ii) [Reserved] this section for the significant new use

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described in paragraph (a)(2) of this new use described in paragraph (a)(2) of section. this section. (2) The significant new uses are: (2) The significant new uses are: (i) Release to water. Requirements as (i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and specified in § 721.90 (a)(1), (b)(1), and (c)(1). (c)(1). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [65 FR 81403, Dec. 26, 2000] [65 FR 81404, Dec. 26, 2000]

§ 721.9486 Rosin amidoamine (generic). § 721.9488 Substituted resorcinols. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substances identified generically as Rosin amidoamine (PMN P-99– cally as substituted resorcinols (PMNs 0145) is subject to reporting under this P-95–1103, P-95–1104, and P-96–1235) are section for the significant new use de- subject to reporting under this section scribed in paragraph (a)(2) of this sec- for the significant new uses described tion. in paragraph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Release to water. Requirements as (i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and specified in § 721.90 (a)(4), (b)(4), and (c)(1). (c)(4) (N = 9). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. The recordkeeping quirements as specified in § 721.125 (a), requirements specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [65 FR 81404, Dec. 26, 2000] [63 FR 3437, Jan. 22, 1998]

§ 721.9487 Polymerized rosin § 721.9490 Coco alklydimethyl amine amidoamine (generic). salts (generic). (a) Chemical substance and significant (a) Chemical substances and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substances identified generically as Polymerized rosin amidoamine cally as coco alkyldimethyl amine (PMN P-99–0146) is subject to reporting salts (PMNs P-98–412/414/415/416/417) are under this section for the significant subject to reporting under this section

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for the significant new uses described 1040) are subject to reporting under in paragraph (a)(2) of this section. this section for the significant new (2) The significant new uses are: uses described in paragraph (a)(2) of (i) Release to water. Requirements as this section. specified in § 721.90 (a)(1), (b)(1), and (2) The significant new uses are: (c)(1). (i) Industrial, commercial and consumer (ii) [Reserved] activities. Requirements as specified in (b) Specific requirements. The provi- § 721.80(l). sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125 (a), paragraph. (b), (c), and (k) are applicable to manu- (1) Recordkeeping. Recordkeeping re- facturers, importers, and processors of quirements as specified in § 721.125(a), this substance. (b), (c), and (i) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [63 FR 44582, Aug. 20, 1998] of § 721.185 apply to this section. § 721.9492 Polymers of styrene, [61 FR 63740, Dec. 2, 1996] cyclohexyl methacrylate and substituted methacrylate. § 721.9497 Trifunctional ketoximino (a) Chemical substance and significant silane. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substances identified generi- new uses subject to reporting. (1) The cally as polymers of styrene, chemical substances identified generi- cyclohexyl methacrylate and sub- cally as trifunctional ketoximino sil- stituted methacrylate (PMNs P-97–143/ ane (PMNs P-95–605 and P-95–606) are 144) are subject to reporting under this subject to reporting under this section section for the significant new uses de- for the significant new uses described scribed in paragraph (a)(2) of this sec- in paragraph (a)(2) of this section. tion. (2) The significant new uses are: (2) The significant new uses are: (i) Protection in the workplace. Re- (i) Industrial, commercial, and con- quirements as specified in § 721.63 (a)(1), sumer activities. Requirements as speci- (a)(2)(i), and (a)(3). fied in § 721.80(f). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a) (b), (c), (d), and (e) are applicable to and (i) are applicable to manufactur- manufacturers, importers, and proc- ers, importers, and processors of these essors of these substances. substances. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [63 FR 3437, Jan. 22, 1998] [63 FR 3437, Jan. 22, 1998] § 721.9499 Modified silicone resin. § 721.9495 Acrylosilane resins. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substances identified as cally as a modified silicone resin (PMN acrylosilane resins (PMNs P-95–1024/ P-96–1649) is subject to reporting under

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this section for the significant new of § 721.185 apply to this significant new uses described in paragraph (a)(2) of use rule. this section. (3) Determining whether a specific use is (2) The significant new uses are: subject to this section. The provisions of (i) Release to water. Requirements as § 721.1725(b)(1) apply to this section. specified in § 721.90 (a)(4), (b)(4), and [55 FR 46775, Nov. 6, 1990. Redesignated and (c)(4) (N = 5). amended at 58 FR 29946, 29947, May 24, 1993; 58 (ii) [Reserved] FR 34204, June 23, 1993] (b) Specific requirements. The provisions of subpart A of this part apply to § 721.9501 Silane, triethoxy[3- this section except as modified by this oxiranylmethoxy)propyl]-. paragraph. (a) Chemical substance and significant (1) Recordkeeping. Recordkeeping renew uses subject to reporting. (1) The quirements as specified in § 721.125 (a), chemical substance identified as silane, (b), (c), and (k) are applicable to manu- triethoxy[3-oxiranylmethoxy)propyl]- facturers, importers, and processors of (PMN P-01–781; CAS No. 2602–34–2) is this substance. subject to reporting under this section (2) Limitations or revocation of certain for the significant new use described in notification requirements. The provisions paragraph (a)(2) of this section. of § 721.185 apply to this section. (2) The significant new uses are: [63 FR 3437, Jan. 22, 1998] (i) Industrial, commercial, and consumer activities. Requirements as speci- § 721.9500 Silane, (1,1-dimethylethoxy) fied in § 721.80(y)(l). dimethoxy(2-methyl propyl)-. (ii) Release to water. Requirements as (a) Chemical substance and significant specified § 721.90(a)(4), (b)(4), and (c)(4) new uses subject to reporting. (1) The (N=10). chemical substance silane, (1,1- (b) Specific requirements. The provi- dimethylethoxy) dimethoxy (2- sions of subpart A of this part apply to methylpropyl)- (PMN P-89–906) is sub- this section except as modified by this ject to reporting under this section for paragraph. the significant new uses described in (1) Recordkeeping. Recordkeeping re- paragraph (a)(2) of this section. quirements as specified in § 721.125(a), (2) The significant new uses are: (b), (c), (i), and (k) are applicable to (i) Protection in the workplace. Re- manufacturers, importers, and proc- quirements as specified in § 721.63 (a)(4), essors of this chemical substance. (a)(5)(iv) through (a)(5)(vii), (a)(6)(i) (2) Limitations or revocation of certain through (a)(6)(vi), (b) (concentration notification requirements. The provisions set at 1.0 percent), and (c). of § 721.185 apply to this section. (ii) Hazard communication program. [68 FR 70183, Dec. 17, 2003] Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 § 721.9502 Siloxanes and silicones, percent), (f), (g)(1)(ii), (g)(2)(ii), aminoalkyl, fluorooctyl, hydroxy- (g)(2)(iv), and (g)(5). terminated salt (generic). (iii) Industrial, commercial, and con- (a) Chemical substance and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80(q). chemical substance identified generi- (b) Specific requirements. The provi- cally as siloxanes and silicones, sions of subpart A of this part apply to aminoalkyl, fluorooctyl, hydroxy-ter- this section except as modified by this minated salt (PMN P-00–1132) is subject paragraph. to reporting under this section for the (1) Recordkeeping. The following rec- significant new use described in para- ordkeeping requirements are applicable graph (a)(2) of this section. to manufacturers, importers, and proc- (2) The significant new uses are: essors of this substance, as specified in (i) Industrial, commercial, and con- § 721.125 (a), (b), (c), (d), (f), (g), (h), and sumer activities. Requirements as speci- (i). fied in § 721.80(j) (graffiti systems) and (2) Limitations or revocation of certain (y)(1). notification requirements. The provisions (ii) [Reserved]

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(b) Specific requirements. The provi- ing under this section for the signifi- sions of subpart A of this part apply to cant new use described in paragraph this section except as modified by this (a)(2) of this section. paragraph. (2) The significant new uses are: (1) Recordkeeping. Recordkeeping re- (i) Protection in the workplace. Re- quirements as specified in § 721.125 (a), quirements as specified in § 721.63 (a)(4), (b), (c), and (i) are applicable to manu- (a)(5)(ii),( (a)(5)(xii), and (a)(5)(xiii). facturers, importers, and processors of (ii) Industrial, commercial, and con- this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(o). notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to (3) Determining whether a specific use is this section except as modified by this subject to this section. The provisions of paragraph. § 721.1725(b)(1) apply to this section. (1) Recordkeeping. Recordkeeping re- [68 FR 15088, Mar. 28, 2003] quirements as specified in § 721.125 (a),(b), (c), (d), and (i) are applicable to § 721.9503 Silane, manufacturers, importers, and proc- (3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10- essors of this substance. heptadecafluorodecyl)trimethoxy-. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified as silane, [68 FR 15088, Mar. 28, 2003] (3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10- heptadecafluorodecyl) trimethoxy- § 721.9505 Silanes substituted (PMN P-97–264; CAS No. 83048–65–1) is macrocycle polyethyl. subject to reporting under this section for the significant new uses described (a) Chemical substances and significant in paragraph (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substances identified generi- (i) Protection in the workplace. Re- cally as silanes substituted macrocycle quirements as specified in § 721.63 (a)(4), polyethyl (PMNs P-93–1423, 1424, 1425, (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), and 1426) are subject to reporting under (a)(5)(xv), (a)(6)(ii), and (a)(6)(v). this section for the significant new (ii) Release to water. Requirements as uses described in paragraph (a)(2) of specified in § 721.90 (a)(4), (b)(4), and this section. (c)(4) (N = 10). (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(1), (b)(1), and this section except as modified by this (c)(1). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), (d), and (k) are applicable to this section except as modified by this manufacturers, importers, and proc- paragraph. essors of this substance. (1) Recordkeeping requirements. Rec- (2) Limitations or revocation of certain ordkeeping requirements specified in notification requirements. The provisions § 721.125 (a), (b), (c), and (k) are applica- of § 721.185 apply to this section. ble to manufacturers, importers, and processors of these substances. [63 FR 3437, Jan. 22, 1998] (2) Limitations or revocation of certain § 721.9504 Silane, triethoxy (3,3,4,4,5,5, notification requirements. The provisions 6,6,7,7,8,8,8-tridecafluorooctyl)-. of § 721.185 apply to this section. (a) Chemical substance and significant [60 FR 11045, Mar. 1, 1995] new uses subject to reporting. (1) The chemical substance identified as silane, § 721.9506 Halogenated arylsilane (ge- triethoxy (3,3,4,4,5, 5,6,6,7,7,8,8,8- neric). tridecafluorooctyl)- (PMN P-99–1346; (a) Chemical substance and significant CAS No. 51851–37–7) is subject to report- new uses subject to reporting. (1) The

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chemical substance identified generi- subject to reporting under this section cally as a halogenated arylsilane (PMN for the significant new uses described P-01–9) is subject to reporting under in paragraph (a)(2) of this section. this section for the significant new use (2) The significant new uses are: described in paragraph (a)(1) of this (i) Hazard communication program. Re- section. quirements as specified in § 721.72 (a), (2) The significant new uses are: (b), (c), (d), (f), (g)(1)(i), (g)(1)(ii), (i) Release to water. Requirements as (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), specified § 721.90(a)(1), (b)(1), and (c)(1). (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (ii) [Reserved] (g)(2)(v), (g)(5). The following state- (b) Specific requirements. The provi- ment shall appear on each label as sions of subpart A of this part apply to specified in § 721.72(b) and the MSDS as this section except as modified by this specified in § 721.72(c): This substance paragraph. may cause death if inhaled. (1) Recordkeeping. Recordkeeping re- (ii) Industrial, commercial, and con- quirements as specified in § 721.125(a), sumer activities. Requirements as speci- (b), (c), and (k) are applicable to manu- fied in § 721.80(y)(1). Use in any formu- facturers, importers, and processors of lation that contains this chemical substance. alkylbenzenesulfonate emulsifiers. (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this paragraph. [68 FR 70183, Dec. 17, 2003] (1) Recordkeeping. The following recordkeeping requirements are applicable § 721.9507 Polyester silane. to manufacturers, importers, and proc- (a) Chemical substance and significant essors of this substance, as specified in new uses subject to reporting. (1) The § 721.125 (a), (b), (c), (f), (g), (h), and (i). chemical substance identified as a pol- (2) Limitations or revocation of certain yester silane (P-95–1022) is subject to notification requirements. The provisions reporting under this section for the sig- of § 721.185 apply to this section. nificant new uses described in paragraph (a)(2) of this section. [65 FR 372, Jan. 5, 2000] (2) The significant new uses are: § 721.9509 Perfluorinatedalkyl (i) Industrial, commercial and consumer polyalkoxysilane (generic). activities. Requirements as specified in (a) Chemical substance and significant § 721.80(l). new uses subject to reporting. (1) The (ii) [Reserved] chemical substance identified generi- (b) Specific requirements. The provi- cally as perfluorinatedalkyl sions of subpart A of this part apply to polyalkoxysilane (PMN P-95–1410) is this section except as modified by this subject to reporting under this section paragraph. for the significant new uses described (1) Recordkeeping. Recordkeeping rein paragraph (a)(2) of this section. quirements as specified in § 721.125 (a), (2) The significant new uses are: (b), (c), and (i) are applicable to manu- (i) Hazard communication program. Re- facturers, importers, and processors of quirements as specified in § 721.72 (a), this substance. (b), (c), (d), (f), (g)(1)(i), (g)(1)(ii), (2) Limitations or revocation of certain (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), notification requirements. The provisions (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), of § 721.185 apply to this section. (g)(2)(v), (g)(5). The following state- [61 FR 63740, Dec. 2, 1996] ment shall appear on each label as specified in § 721.72(b) and the MSDS as § 721.9508 Perfluorinatedalkyl specified in § 721.72(c): This substance polyhydroxysilane (generic). may cause death if inhaled. (a) Chemical substance and significant (ii) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified generi- fied in § 721.80(y)(1). Use in any formu- cally as perfluorinatedalkyl lation that contains polyhydroxysilane (PMN P-95–1400) is alkylbenzenesulfonate emulsifiers.

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(b) Specific requirements. The provi- nificant new uses described in para- sions of subpart A of this part apply to graph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Industrial, commercial, and con- (1) Recordkeeping. The following rec- sumer activities. Requirements as speci- ordkeeping requirements are applicable fied in § 721.80 (v)(1), (w)(1), and (x)(1). to manufacturers, importers, and proc- (ii) [Reserved] essors of this substance as specified in (b) Specific requirements. The provi- § 721.125 (a), (b), (c), (f), (g), (h), and (i). sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this section. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), [65 FR 372, Jan. 5, 2000] (b), (c), and (i) are applicable to manufacturers, importers, and processors of § 721.9511 Silicic acid (H6SiO2O7), magnesium, strontium salt(1:1:2), dys- this substance. prosium and europium-doped. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified as silicic [65 FR 372, Jan. 5, 2000] acid (H6SiO2O7) magnesium, strontium salt(1:1:2), dysprosium and europium- § 721.9514 Ethyl silicate, reaction prod- doped. (PMN P-98–848; CAS No.181828– ucts with modified alkoxysilane salt 07–9) is subject to reporting under this (generic). section for the significant new use de- (a) Chemical substance and significant scribed in paragraph (a)(2) of this sec- new uses subject to reporting. (1) The tion. chemical substance identified generi- (2) The significant new uses are: cally as Ethyl silicate, reaction prod- (i) Industrial, commercial, and con- ucts with modified alkoxysilane salt sumer activities. Requirements as speci- (PMN P-99–0157) is subject to reporting fied in § 721.80(j) (manufacture or im- under this section for the significant port of the chemical substance where new uses described in paragraph (a)(2) greater than 5% of the chemical sub- of this section. stance is below the 10 micron (res- (2) The significant new uses are: pirable particles) threshold). (i) Release to water. Requirements as (ii) [Reserved] specified in § 721.90 (a)(1), (b)(1), and (b) Specific requirements. The provi- (c)(1). sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125(a), paragraph. (b), (c), and (i) are applicable to manu- (1) Recordkeeping. Recordkeeping re- facturers, importers, and processors of quirements as specified in § 721.125 (a), this chemical substance. (b), (c), and (k) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [68 FR 70183, Dec. 17, 2003] of § 721.185 apply to this section. § 721.9513 Modified magnesium silicate [65 FR 81404, Dec. 26, 2000] polymer (generic). (a) Chemical substance and significant § 721.9515 Aminofunctional alkoxy new uses subject to reporting. (1) The alkyl siloxane. chemical substance identified generi- (a) Chemical substance and significant cally as modified magnesium silicate new uses subject to reporting. (1) The polymer (PMN P-98–604) is subject to chemical substance identified generi- reporting under this section for the sig- cally as an aminofunctional alkoxy

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alkyl siloxane (PMN P-96–346) is sub- § 721.9517 Siloxanes and silicones, de- ject to reporting under this section for Me, 3-[4-[[[3-(dimethyl amino) the significant new uses described in propyl] amino]carbonyl]-2-oxo-1- paragraph (a)(2) of this section. pyrrolidinyl] propyl Me. (2) The significant new uses are: (a) Chemical substance and significant (i) Release to water. Requirements as new uses subject to reporting. (1) The specified in § 721.90 (a)(1), (b)(1), and chemical substance identified as (c)(1). siloxanes and silicones, de-Me, 3-[4-[[[3- (ii) [Reserved] (dimethylamino) propyl]amino] car- (b) Specific requirements. The provi- bonyl]-2-oxo-1-pyrrolidinyl]propyl Me sions of subpart A of this part apply to (PMN P-97–332) is subject to reporting this section except as modified by this under this section for the significant paragraph. new uses described in paragraph (a)(2) of this section. (1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a), (i) Industrial, commercial, and con- (b), (c), and (k) are applicable to manu- sumer activities. Requirements as speci- facturers, importers, and processors of fied in § 721.80(y)(1). this substance. (ii) [Reserved] (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this [63 FR 3437, Jan. 22, 1998] paragraph. (1) Recordkeeping. Recordkeeping re- § 721.9516 Siloxanes and silicones, 3- quirements as specified in § 721.125 (a), [(2-aminoethyl) amino]propyl Me, (b), (c), and (i) are applicable to manu- di-Me, reaction products with poly- facturers, importers, and processors of ethylene-polypropylene glycol Bu this substance. glycidal ether. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generi- [63 FR 44582, Aug. 20, 1998] cally as siloxanes and silicones, 3-[(2- aminoethyl) amino]propyl Me, di-Me, § 721.9518 Sinorhizobium meliloti reaction products with polyethylene- strain RMBPC–2. polypropylene glycol Bu glycidyl ether (a) Microorganism and significant new (PMN P-97–740; CAS No. 189354–73–2) is uses subject to reporting. (1) The micro- subject to reporting under this section organism identified as Sinorhizobium for the significant new uses described meliloti strain RMBPC-2 (PMN P-92–403) in paragraph (a)(2) of this section. is subject to reporting under this sec- (2) The significant new uses are: tion for the significant new uses de- (i) Industrial, commercial, and con- scribed in paragraph (a)(2) of this sec- sumer activities. Requirements as speci- tion. fied in § 721.80(y)(1). (2) The significant new uses are: (ii) [Reserved] (i) Commercial activities before submit- (b) Specific requirements. The provi- ting a TSCA section 5(a) notice. For any sions of subpart A of this part apply to manufacturer or importer who has not this section except as modified by this previously submitted a premanufacture paragraph. notice or significant new use notice for (1) Recordkeeping. Recordkeeping re- this microorganism, the significant quirements specified in § 721.125 (a), (b), new use is any use. (c), and (i) are applicable to manufac- (ii) Commercial activities after submit- turers, importers, and processors of ting a TSCA section 5(a) notice. For any this substance. manufacturer or importer who has previously submitted a premanufacture (2) Limitations or revocation of certain notice or a significant new use notice notification requirements. The provisions for this microorganism, the significant of § 721.185 apply to this section. new use is manufacture, import, or [63 FR 44582, Aug. 20, 1998] processing greater than a maximum

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production volume of 500,000 lbs in any chemical substance identified as so- consecutive 12-month period. dium perthiocarbonate (PMN P-94–2166) (b) Specific requirements. The provi- is subject to reporting under this sec- sions of subpart A of this part apply to tion for the significant new uses de- this section except as modified by this scribed in paragraph (a)(2) of this sec- paragraph. tion. (1) Persons who must report. Section (2) The significant new uses are: 721.5 applies to this section except for (i) Release to water. Requirements as § 721.5(a)(2). A person who intends to specified in § 721.90 (a)(1), (b)(1), and manufacture or import this substance (c)(1). for commercial purposes must have (ii) [Reserved] submitted a premanufacture notice or (b) Specific requirements. The provi- submit a significant new use notice. sions of subpart A of this part apply to (2) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125 (a) paragraph. and (i) are applicable to manufacturers and importers of this substance. (1) Recordkeeping. Recordkeeping re- (3) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of this substance. [63 FR 29648, June 1, 1998] (2) Limitations or revocation of certain notification requirements. The provisions § 721.9520 Methylated-para-rosaniline salt of a trisulfonated triaryl- of § 721.185 apply to this section. methane dye (generic). [60 FR 45084, Aug. 30, 1995] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.9527 Bis(1,2,2,6,6-pentamethyl-4- chemical substance identified generi- piperidin-4-ol) ester of cycloali- cally as methylated-para-rosaniline phatic spiroketal. salt of a trisulfonated triarylmethane (a) Chemical substance and significant dye (PMN P-00–0559) is subject to renew uses subject to reporting. (1) The porting under this section for the sig- chemical substance identified generi- nificant new use described in paragraph cally as bis(1,2,2,6,6-pentamethyl-4- (a)(2) of this section. piperidin-4-ol) ester of cycloaliphatic (2) The significant new uses are: spiroketal (PMN No. P-91–1361) is sub- (i) Industrial, commercial, and con- ject to reporting under this section for sumer activities. Requirements as speci- the significant new uses described in fied in § 721.80(f). paragraph (a)(2) of this section. (ii) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(4), (b)(4), (c)(4) (i) Protection in the workplace. For (N=2 ppb). manufacturing workers only, require- (b) Specific requirements. The provi- ments as specified in § 721.63 (a)(4), sions of subpart A of this part apply to (a)(5)(i), (a)(6)(i), and (b) (concentration this section except as modified by this set at 1.0 percent). For processing/use paragraph. workers only, requirements as specified (1) Recordkeeping. Recordkeeping rein § 721.63(a)(4), (a)(5)(iv), (a)(5)(v), quirements as specified in § 721.125 (a), (a)(5)(vi), (a)(5)(vii), (a)(6)(i), (b) (con- (b), (c), (i), and (k) are applicable to centration set at 1.0 percent), and (c). manufacturers, importers, and proc- (ii) Hazard communication program. essors of this substance. Requirements as specified in § 721.72 (a), (2) Limitations or revocation of certain (b), (c), (d), (e) (concentration set at 1.0 notification requirements. The provisions percent), (f), (g)(1)(vi), (g)(1)(viii), of § 721.185 apply to this section. (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(3)(ii), [68 FR 15088, Mar. 28, 2003] (g)(4)(iii), and (g)(5). The following additional statements shall appear on § 721.9526 Sodium perthiocarbonate. each label and MSDS required by this (a) Chemical substance and significant paragraph: This substance may cause new uses subject to reporting. (1) The systemic effects, eye irritation.

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(iii) Industrial, commercial, and con- (iii) Industrial, commercial, and consumer activities. Requirements as speci- sumer activities. Requirements as specified in § 721.80(l). fied in § 721.80(l). (iv) Release to water. Requirements as (iv) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and specified in § 721.90 (a)(1), (b)(1), and (c)(1). (c)(1). (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. The following rec- quirements as specified in § 721.125 (a) ordkeeping requirements are applicable through (d), (f) through (i), and (k) are to manufacturers, importers, and proc- applicable to manufacturers, import- essors of this substance, as specified in ers, and processors of this substance. § 721.125 (a), (b), (c), (d), (f), (g), (h), (i), (2) Limitations or revocation of certain and (k). notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this significant new notification requirements. The provisions use rule. of § 721.185 apply to this significant new (3) Determining whether a specific use is use rule. subject to this section. The provisions of § 721.1725(b)(1) apply to this section. [56 FR 40215, Aug. 13, 1991. Redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR [58 FR 32241, June 8, 1993, as amended at 58 34204, June 23, 1993] FR 29946, May 24, 1993] § 721.9535 1,4-Dioxa-7,9-dithia-8- § 721.9530 Bis(2,2,6,6-tetramethylpiper- stannacycloundecane-5,11-dione, idinyl) ester of cycloalkyl spiroke- 8,8-dioctyl-. tal. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified as a 1,4- chemical substance identified generi- Dioxa-7,9-dithia-8- cally as bis(2,2,6,6-tetramethyl piper- stannacycloundecane-5,11-dione, 8,8- idinyl) ester of cycloalkyl spiroketal dioctyl- (PMN P-99–0093; CAS No. 56875– (PMN P-88–0083) is subject to reporting 68–4) is subject to reporting under this under this section for the significant section for the significant new use de- new uses described in paragraph (a)(2) scribed in paragraph (a)(2) of this sec- of this section. tion. (2) The significant new uses are: (2) The significant new uses are: (i) Protection in the workplace. For the (i) Industrial, commercial, and con- manufacturing workers only, require- sumer activities. Requirements as speciments as specified in § 721.63 (a)(4), fied in § 721.80(j) and (f). (a)(5)(i), (a)(6)(i), and (b) (concentration (ii) [Reserved] set at 1.0 percent). For the processing/ (b) Specific requirements. The provi- use workers only, requirements as sions of subpart A of this part apply to specified in § 721.63 (a)(4), (a)(5)(iv), this section except as modified by this (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(6)(i), paragraph. (b) (concentration set at 1.0 per cent) (1) Recordkeeping. Recordkeeping re- and (c). quirements as specified in § 721.125 (a), (ii) Hazard communication program. (b), (c), and (i) are applicable to manu- Requirements as specified in § 721.72 (a), facturers, importers, and processors of (b), (c), (d), (e) (concentration set at 1.0 this substance. percent), (f), (g)(1)(vi), (g)(1)(viii), (2) Limitations or revocation of certain (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(3)(ii), notification requirements. The provisions (g)(4)(iii), and (g)(5). The following ad- of § 721.185 apply to this section. ditional human health hazard state- (3) Determining whether a specific use is ments shall appear on each label and subject to this section. The provisions of MSDS required by this paragraph: This § 721.1725(b)(1) apply to this section. substance may cause: systemic effects, eye irritation. [65 FR 81404, Dec. 26, 2000]

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§ 721.9538 Lithium salt of sulfophenyl the employer becomes aware of the new azo phenyl azo disulfostilbene (ge- information. If this substance is not neric). being manufactured, imported, proc- (a) Chemical substance and significant essed, or used in the employer’s work- new uses subject to reporting. (1) The place, the employer must add the new chemical substance identified generi- information to an MSDS before the cally as lithium salt of sulfophenyl azo substance is reintroduced into the phenyl azo disulfostilbene (PMN P-00– workplace. 0698) is subject to reporting under this (B) The employer must ensure that section for the significant new use de- persons who will receive, or who have scribed in paragraph (a)(2) of this sec- received this substance from the em- tion. ployer within 5 years from the date the (2) The significant new uses are: employer becomes aware of the new in- (i) Industrial, commercial, and con- formation described in paragraph sumer activities. Requirements as speci- (a)(2)(i)(A) of this section, are provided fied in § 721.80 (v)(2), (w)(2), (x)(2). an MSDS as described in § 721.72(c) con- (ii) [Reserved] taining the information required under (b) Specific requirements. The provi- paragraph (a)(2)(i)(A) of this section sions of subpart A of this part apply to within 90 days from the time the Com- this section except as modified by this pany becomes aware of the new infor- paragraph. (1) Recordkeeping. Recordkeeping re- mation. Requirements as specified in quirements as specified in § 721.125 (a), § 721.72 (a), (b), (c), (d), (f), and (b), (c), and (i) are applicable to manu- (g)(4)(iii). facturers, importers, and processors of (ii) Industrial, commercial, and con- this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(p) (153,000 kg). notification requirements. The provisions (iii) Release to water. Requirements of § 721.185 apply to this section. as specified in § 721.90 (a)(1), (b)(1), and (c)(1). [68 FR 15088, Mar. 28, 2003] (b) Specific requirements. The provi- § 721.9540 Polysulfide mixture. sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified generi- (1) Recordkeeping requirements. Rec- cally as a polysulfide mixture (PMN P- ordkeeping requirements specified in 93–1043) is subject to reporting under § 721.125 (a), (b), (c), (f), (g), (h), (i), (k) this section for the significant new are applicable to manufacturers, im- uses described in paragraph (a)(2) of porters, and processors of this sub- this section. stance. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Hazard communication program. A notification requirements. The provisions significant new use of this substance is of § 721.185 apply to this section. any manner or method of manufacture, import, or processing associated with [60 FR 11045, Mar. 1, 1995] any use of this substance without pro- § 721.9545 Substituted phenyl azo sub- viding risk notification as follows: stituted sulfocarbopolycle, sodium (A) If, as a result of the test data re- salt. quired under the section 5(e) consent order for this substance, the employer (a) Chemical substance and significant becomes aware that this substance new uses subject to reporting. (1) The may present a risk of injury to human chemical substance identified generi- health, or the environment, the em- cally as a substituted phenyl azo sub- ployer must incorporate this new infor- stituted sulfocarbopolycle, sodium salt mation, and any information on meth- (PMN P-96–1263) is subject to reporting ods for protecting against such risk, under this section for the significant into the applicable Material Safety new uses described in paragraph (a)(2) Data Sheet (MSDS) as described in of this section. § 721.72(c) within 90 days from the time (2) The significant new uses are:

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(i) Industrial, commercial, and con- (3) Determining whether a specific use is sumer activities. Requirements as speci- subject to this section. The provisions of fied in § 721.80 (v)(1), (w)(1), and (x)(1). § 721.1725(b)(1) apply to this section. (ii) [Reserved] [57 FR 44074, Sept. 23, 1992, as amended at 58 (b) Specific requirements. The provi- FR 29946, May 24, 1993; 58 FR 34204, June 23, sions of subpart A of this part apply to 1993] this section except as modified by this paragraph. § 721.9570 Halophenyl sulfonamide (1) Recordkeeping. Recordkeeping re- salt. quirements as specified in § 721.125 (a), (a) Chemical substance and significant (b), (c), and (i) are applicable to manu- new uses subject to reporting. (1) The facturers, importers, and processors of chemical substance identified generi- this substance. cally as halophenyl sulfonamide salt (2) Limitations or revocation of certain (PMN P-90–1730) is subject to reporting notification requirements. The provisions under this section for the significant of § 721.185 apply to this section. new uses described in paragraph (a)(2) [63 FR 3437, Jan. 22, 1998] of this section. (2) The significant new uses are: § 721.9550 Sulfonamide. (i) Hazard communication program. Re- (a) Chemical substance and significant quirements as specified in § 721.72 (a), new uses subject to reporting. (1) The (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), chemical substance generically identi- (g)(4)(i), and (g)(5). fied as a sulfonamide (PMN P-90–1732) (ii) Industrial, commercial, and con- is subject to reporting under this sec- sumer activities. Requirements as speci- tion for the significant new uses de- fied in § 721.80 (g) and (q). scribed in paragraph (a)(2) of this sec- (iii) Release to water. Requirements as tion. specified in § 721.90 (a)(4), (b)(4), and (2) The significant new uses are: (c)(4) (N = 10 ppb). (i) Protection in the workplace. Re- (b) Specific requirements. The provi- quirements as specified in § 721.63 (a)(1), sions of subpart A of this part apply to (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), this section except as modified by this (a)(4), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), paragraph. (a)(5)(vii), (a)(6)(i), (b) (concentration (1) Recordkeeping requirements. Rec- set at 1.0 percent) and (c). ordkeeping requirements as specified (ii) Hazard communication program. at § 721.125 (a), (b), (c), (f), (g), (h), (i), Requirements as specified in § 721.72 (a), and (k) are applicable to manufactur- (b), (c), (d), (e) (concentration set at 0.1 ers, importers, and processors of this percent), (f), (g)(1)(i), (g)(1)(iv), (g)(2)(i), substance. (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (2) Limitations or revocation of certain (g)(3)(i), (g)(3)(ii), (g)(4)(i), (g)(4)(ii), and notification requirements. The provisions (g)(5). of § 721.185 apply to this section. (iii) Industrial, commercial, and con- (3) Determining whether a specific use is sumer activities. Requirements as speci- subject to this section. The provisions of fied in § 721.80(q). § 721.1725(b)(1) apply to this section. (iv) Release to water. Requirements as [57 FR 31970, July 20, 1992, as amended at 58 specified in § 721.90 (a)(4), (b)(4), and FR 29946, May 24, 1993; 58 FR 34204, June 23, (c)(4) (where N = 10 ppb). 1993] (b) Specific requirements. The provisions of subpart A of this part apply to § 721.9572 Substituted alkyl sul- this section except as modified by this fonamide (generic). paragraph. (a) Chemical substance and significant (1) Recordkeeping requirements. Re- new uses subject to reporting. (1) The quirements as specified in § 721.125 (a) chemical substance identified generi- through (k) are applicable to manufac- cally as substituted alkyl sulfonamide turers, importers, and processors of (PMN P-00–838) is subject to reporting this substance. under this section for the significant (2) Limitations or revocation of certain new use described in paragraph (a)(2) of notification requirements. The provisions this section. of § 721.185 apply to this section. (2) The significant new uses are:

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(i) Release to water. Requirements as chemical substance identified as chro- specified in § 721.90(a)(4), (b)(4), and mate(3-), bis[3-[[5-(aminosulfonyl)-2- (c)(4) (N=1). hydroxyphenyl]azo]-4-hydroxy-7-[[2- (ii) [Reserved] oxo-1-[(phenylamino)carbonyl] (b) Specific requirements. The provi- propyl]azo]-2-naphthalene sulfonato(3- sions of subpart A of this part apply to )]-, trisodium (9CI) (PMN P-95–1575; this section except as modified by this CAS No. 119535–63–6) is subject to re- paragraph. porting under this section for the sig- (1) Recordkeeping. Recordkeeping re- nificant new uses described in para- quirements as specified in § 721.125(a), graph (a)(2) of this section. (b), (c), and (k) are applicable to manu- (2) The significant new uses are: facturers, importers, and processors of (i) Industrial, commercial, and con- this chemical substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80 (v)(1), (w)(1), and (x)(1). notification requirements. The provisions (ii) [Reserved] of § 721.185 apply to this section. (b) Specific requirements. The provi- [68 FR 70183, Dec. 17, 2003] sions of subpart A of this part apply to this section except as modified by this § 721.9573 Substituted perfluoroalkyl paragraph. sulfonamide (generic). (1) Recordkeeping. Recordkeeping re- (a) Chemical substance and significant quirements as specified in § 721.125 (a), new uses subject to reporting. (1) The (b), (c), and (i) are applicable to manu- chemical substance identified generi- facturers, importers, and processors of cally as a substituted perfluoroalkyl this substance. sulfonamide (PMN P-98–645) is subject (2) Limitations or revocation of certain to reporting under this section for the notification requirements. The provisions significant new use described in para- of § 721.185 apply to this section. graph (a)(2) of this section. (2) The significant new uses are: [63 FR 3438, Jan. 22, 1998] (i) Industrial, commercial, and consumer activities. Requirements as speci- § 721.9576 Chromate(3-), bis[7- [(aminohydroxyphenyl)azo]-3-[[5- fied in § 721.80(j). (aminosulfonyl)-2- (ii) [Reserved] hydroxyphenyl]azo]-4-hydroxy-2- (b) Specific requirements. The provi- naphthalene-sulfonato (3-)]-, tri- sions of subpart A of this part apply to sodium (9CI). this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping. Recordkeeping re- chemical substance identified as chro- quirements as specified in § 721.125 (a), mate(3-), bis[7- (b), (c), and (i) are applicable to manu- [(aminohydroxyphenyl)azo]-3-[[5- facturers, importers, and processors of (aminosulfonyl)-2-hydroxyphenyl]azo]- this substance. 4-hydroxy-2-naphthalene-sulfonato (3- (2) Limitations or revocation of certain )]-, trisodium (9CI) (PMN P-95–1576; notification requirements. The provisions CAS No. 118716–62–4) is subject to re- of § 721.185 apply to this section. porting under this section for the sig- (3) Determining whether a specific use is nificant new uses described in para- subject to this section. The provisions of graph (a)(2) of this section. § 721.1725(b)(1) apply to this section. (2) The significant new uses are: [65 FR 372, Jan. 5, 2000] (i) Industrial, commercial, and consumer activities. Requirements as speci- § 721.9575 Chromate(3-), bis[3-[[5- fied in § 721.80 (v)(1), (w)(1), and (x)(1). (aminosulfonyl)-2- hydroxyphenyl]azo]-4-hydroxy-7-[[2- (ii) [Reserved] oxo-1-[(phenylamino)carbonyl] (b) Specific requirements. The provi- propyl]azo]-2- sions of subpart A of this part apply to naphthalenesulfonato(3-)]-, tri- this section except as modified by this sodium (9CI). paragraph. (a) Chemical substance and significant (1) Recordkeeping. Recordkeeping renew uses subject to reporting. (1) The quirements as specified in § 721.125 (a),

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(b), (c), and (i) are applicable to manu- (b), (c), and (i) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [63 FR 3438, Jan. 22, 1998] [63 FR 3438, Jan. 22, 1998] § 721.9577 Chromate(3-), bis[7- [(aminohydroxyphenyl)azo]-3-[[5- § 721.9580 Ethyl methanesulfonate. (aminosulfonyl)-2-hydroxyphenyl] (a) Chemical substance and significant azo]-4-hydroxy-2-naphthalene new use subject to reporting. (1) The sulfonato (3-)]-,-[[5-(aminosulfonyl) -2-hydroxyphenyl]azo]-4-hydroxy-7- chemical substance ethyl [[2-hydroxy-1-[(phenylamino) car- methanesulfonate (CAS No. 62–50–0) is bonyl]-1-propenyl]azo]-2- subject to reporting under this section naphthalenesulfonato(3-)]-, tri- for the significant new use described in sodium (9CI). paragraph (a)(2) of this section. (a) Chemical substance and significant (2) The significant new use is: Manu- new uses subject to reporting. (1) The facture, import, or processing of 10,000 chemical substance identified as chro- pounds or more per year per facility for mate(3-), bis[7- any use. [(aminohydroxyphenyl)azo]-3-[[5- (b) Specific requirements. The provi- (aminosulfonyl)-2-hydroxy phenyl] sions of subpart A of this part apply to azo]-4-hydroxy-2-naphthalenesulfonato this section except as modified by this (3-)]-,-[[5-(aminosulfonyl) -2- hydroxyphenyl]azo]-4-hydroxy-7-[[2-hy- paragraph. droxy-1-[(phenylamino) carbonyl]-1- (1) Recordkeeping. The following rec- propenyl]azo]-2-naphthalene ordkeeping requirements are applicable sulfonato(3-)]-, trisodium (9CI) (PMN P- to manufacturers, importers, and proc- 95–1577; CAS No. 118716–61–3) is subject essors of this substance, as specified in to reporting under this section for the § 721.125 (a), (b), and (c). significant new uses described in para- (2) [Reserved] graph (a)(2) of this section. [58 FR 63518, Dec. 1, 1993] (2) The significant new uses are: (i) Industrial, commercial, and con- § 721.9582 Certain perfluoroalkyl sumer activities. Requirements as speci- sulfonates. fied in § 721.80 (v)(1), (w)(1), and (x)(1). (ii) [Reserved] (a) Chemical substances and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substances listed in Table 1, this section except as modified by this Table 2, and Table 3 of this section are paragraph. subject to reporting under this section (1) Recordkeeping. Recordkeeping re- for the significant new uses described quirements as specified in § 721.125 (a), in paragraph (a)(2) of this section.

TABLE 1—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER JANUARY 1, 2001

CAS No./PMN CAS Ninth Collective Index Name

2250–98–8 1-Octanesulfonamide, N,N′,N″-[phosphinylidynetris(oxy-2,1-ethanediyl)]tris[N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-

30381–98–7 1-Octanesulfonamide, N,N′-[phosphinicobis(oxy-2,1-ethanediyl)]bis[N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, ammonium salt

57589–85–2 Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3- [[(heptadecafluorooctyl)sulfonyl]oxy]phenyl]amino]carbonyl]-, monopotassium salt

61660–12–6 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[3- (trimethoxysilyl)propyl]-

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TABLE 1—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER JANUARY 1, 2001—Continued

CAS No./PMN CAS Ninth Collective Index Name

67969–69–1 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[2- (phosphonooxy)ethyl]-, diammonium salt

68608–14–0 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 1,1′- methylenebis[4-isocyanatobenzene]

70776–36–2 2-Propenoic acid, 2-methyl-, octadecyl ester, polymer with 1,1-dichloroethene, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, N-(hydroxymethyl)-2- propenamide, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate

127133–66–8 2-Propenoic acid, 2-methyl-, polymers with Bu methacrylate, lauryl methacrylate and 2- [methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl methacrylate

148240–78–2 Fatty acids, C18-unsatd., trimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters

148684–79–1 Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 1,6- diisocyanatohexane homopolymer and ethylene glycol

178535–22–3 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), polymers with 1,1′- methylenebis[4-isocyanatobenzene] and polymethylenepolyphenylene isocyanate, 2- ethylhexyl esters, Me Et ketone oxime-blocked

P-94–2205 Polymethylenepolyphenylene isocyanate and bis(4-NCO-phenyl)methane reaction products with 2-ethyl-1-hexanol, 2-butanone, oxime, N-ethyl-N-(2- hydroxyethyl)-1-C4-C8 perfluoroalkanesulfonamide

P-96–1645 Fatty acids, C18-unsatd., dimers, 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl esters 306974–63–0

TABLE 2—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER JANUARY 1, 2003

CAS No./PMN CAS Ninth Collective Index Name

307–35–7 1-Octanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-

307–51–7 1-Decanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heneicosafluoro-

376–14–7 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester

383–07–3 2-Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester

423–50–7 1-Hexanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-

423–82–5 2-Propenoic acid, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester

754–91–6 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-

1652–63–7 1-Propanaminium, 3-[[(heptadecafluorooctyl)sulfonyl]amino]-N,N,N-trimethyl-, iodide

1691–99–2 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-

1763–23–1 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-

2795–39–3 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, potassium salt

2991–51–7 Glycine, N-ethyl-N-[(heptadecafluorooctyl)sulfonyl]-, potassium salt

4151–50–2 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-

14650–24–9 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester

17202–41–4 1-Nonanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-nonadecafluoro-, ammonium salt

24448–09–7 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-N- methyl-

25268–77–3 2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester

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TABLE 2—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER JANUARY 1, 2003—Continued

CAS No./PMN CAS Ninth Collective Index Name

29081–56–9 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, ammonium salt

29117–08–6 Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl]-.omega.- hydroxy-

29457–72–5 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, lithium salt

31506–32–8 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-methyl-

38006–74–5 1-Propanaminium, 3-[[(heptadecafluorooctyl)sulfonyl]amino]-N,N,N-trimethyl-, chloride

38850–58–7 1-Propanaminium, N-(2-hydroxyethyl)-N,N-dimethyl-3-[(3- sulfopropyl)[(tridecafluorohexyl)sulfonyl]amino]-, inner salt

55120–77–9 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, lithium salt

67584–42–3 Cyclohexanesulfonic acid, decafluoro(pentafluoroethyl)-, potassium salt

67906–42–7 1-Decanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heneicosafluoro-, ammonium salt

68156–01–4 Cyclohexanesulfonic acid, nonafluorobis(trifluoromethyl)-, potassium salt

68298–62–4 2-Propenoic acid, 2-[butyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, telomer with 2- [butyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, methyloxirane polymer with oxirane di-2-propenoate, methyloxirane polymer with oxirane mono-2-propenoate and 1- octanethiol

68329–56–6 2-Propenoic acid, eicosyl ester, polymer with 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, hexadecyl 2-propenoate, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate and octadecyl 2-propenoate

68541–80–0 2-Propenoic acid, polymer with 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl 2-methyl-2- propenoate and octadecyl 2-propenoate

68555–90–8 2-Propenoic acid, butyl ester, polymer with 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate

68555–91–9 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, polymer with 2-[ethyl[(nonafluorobutyl)sulfonyl]amino] ethyl 2-methyl-2-propenoate, 2- [ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2-methyl-2-propenoate

68555–92–0 2-Propenoic acid, 2-methyl-, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, polymer with 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and octadecyl 2- methyl-2-propenoate

68586–14–1 2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, telomer with 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, .alpha.-(2-methyl-1-oxo-2-propenyl)-.omega.-hydroxypoly(oxy-1,2-ethanediyl), .alpha.-(2-methyl-1-oxo-2-propenyl)- .omega.-[(2-methyl-1-oxo-2-propenyl)oxy]poly(oxy-1,2-ethanediyl), 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[ (tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate and 1-octanethiol

68649–26–3 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-, reaction products with N-ethyl-1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-1- butanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)- 1-heptanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-(2-hydroxyethyl)-1- hexanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(2-hydroxyethyl)-1- pentanesulfonamide, polymethylenepolyphenylene isocyanate and stearyl alc.

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TABLE 2—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER JANUARY 1, 2003—Continued

CAS No./PMN CAS Ninth Collective Index Name

68867–60–7 2-Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, polymer with 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate and .alpha.-(1-oxo-2-propenyl)-.omega.-methoxypoly(oxy-1,2-ethanediyl)

68867–62–9 2-Propenoic acid, 2-methyl-, 2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl ester, telomer with 2-[ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 1-octanethiol and .alpha.-(1-oxo-2-propenyl)-.omega.-methoxypoly(oxy-1,2-ethanediyl)

68891–96–3 Chromium, diaquatetrachloro[.mu.-[N-ethyl-N-[(heptadecafluorooctyl)sulfonyl]glycinato- .kappa.O:.kappa.O’]]-.mu.-hydroxybis(2-methylpropanol)di-

68909–15–9 2-Propenoic acid, eicosyl ester, polymers with branched octyl acrylate, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl acrylate, 2-[methyl [(nonafluorobutyl)sulfonyl]amino]ethyl acrylate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl acrylate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl acrylate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl acrylate, polyethylene glycol acrylate Me ether and stearyl acrylate

68958–61–2 Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl]-.omega.- methoxy-

70225–14–8 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, compd. with 2,2′- iminobis[ethanol] (1:1)

71487–20–2 2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, 2- [[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, 2- [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate, 2- [methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate and 2-propenoic acid

73772–32–4 1-Propanesulfonic acid, 3-[[3-(dimethylamino)propyl][(tridecafluorohexyl)sulfonyl]amino]-2-hydroxy-, monosodium salt

81190–38–7 1-Propanaminium, N-(2-hydroxyethyl)-3-[(2-hydroxy-3- sulfopropyl)[(tridecafluorohexyl)sulfonyl]amino]-N,N-dimethyl-, hydroxide, monosodium salt

91081–99–1 Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with epichlorohydrin, adipates (esters)

94133–90–1 1-Propanesulfonic acid, 3-[[3-(dimethylamino)propyl][(heptadecafluorooctyl)sulfonyl]amino]-2- hydroxy-, monosodium salt

98999–57–6 Sulfonamides, C7-8-alkane, perfluoro, N-methyl-N-[2-[(1-oxo-2-propenyl)oxy]ethyl], polymers with 2-ethoxyethyl acrylate, glycidyl methacrylate and N,N,N-trimethyl-2-[(2-methyl-1-oxo-2- propenyl)oxy]ethanaminium chloride

117806–54–9 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, lithium salt

129813–71–4 Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-(oxiranylmethyl)

148240–80–6 Fatty acids, C18-unsatd., trimers, 2-[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl esters

148240–82–8 Fatty acids, C18-unsatd., trimers, 2-[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl esters

182700–90–9 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-methyl-, reaction products with benzene-chlorine-sulfur chloride (S2Cl2) reaction products chlorides

L–92–0151 2-Propenoic acid, 2-methyl-, butyl ester, polymer with 2- [ethyl[(heptadecafluorooctyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate and 2-propenoic acid

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TABLE 2—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER JANUARY 1, 2003—Continued

CAS No./PMN CAS Ninth Collective Index Name

P-80–0183 Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethylamino)propyl], reaction products with 192662–29–6 acrylic acid

P-83–1102 Fatty acids, linseed-oil, dimers, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl esters 306973–46–6

P-84–1163 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 2-ethyl-2- 306975–56–4 (hydroxymethyl)-1,3-propanediol and N,N′,2-tris(6-isocyanatohexyl)imidodicarbonic diamide, reaction products with N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-1-octanesulfonamide and N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2- hydroxyethyl)-1-heptanesulfonamide, compds. with triethylamine

P-84–1171 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,1′-methylenebis[4- 306975–57–5 isocyanatobenzene] and 1,2,3-propanetriol, reaction products with N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-1-octanesulfonamide and N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-1- heptanesulfonamide, compds. with morpholine

P-86–0301 Sulfonamides, C4-8-alkane, perfluoro, N-(hydroxyethyl)-N-methyl, reaction products with 12- 306973–47–7 hydroxystearic acid and 2,4-TDI, ammonium salts

P-86–0958 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with 2-[methyl[(perfluoro-C4-8- 306975–62–2 alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride

P-89–0799 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with 2-ethyl- 160901–25–7 1-hexanol and polymethylenepolyphenylene isocyanate

P-90–0111 Sulfonamides, C4-8-alkane, perfluoro, N-methyl-N-[(3-octadecyl-2-oxo-5-oxazolidinyl)methyl] 306974–19–6

P-91–1419 Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, polymer with 1,6- 306975–84–8 diisocyanatohexane, N-(hydroxyethyl)-N-methyl perfluoro C4-8-alkane sulfonamides-blocked

P-93–1444 2-Propenoic acid, 2-methyl-, dodecyl ester, polymers with N-(hydroxymethyl)-2-propenamide, 306975–85–9 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl methacrylate, stearyl methacrylate and vinylidene chloride

P-94–0545 1-Hexadecanaminium, N,N-dimethyl-N-[2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl]-, bromide, 306976–25–0 polymers with Bu acrylate, Bu methacrylate and 2-[methyl[(perfluoro-C4-8- alkyl)sulfonyl]amino]ethyl acrylate

P-94–0927 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with 2,4-diisocyanato-1- 306976–55–6 methylbenzene, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and 2-propenoic acid, N-ethyl-N- (hydroxyethyl)perfluoro-C4-8-alkanesulfonamides-blocked

P-94–2206 Siloxanes and Silicones, di-Me, mono[3-[(2-methyl-1-oxo-2-propenyl)oxy]propylgroup]-termi- 306974–28–7 nated, polymers with 2-[methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and stearyl methacrylate

P-95–0120 Sulfonamides, C4-8-alkane, perfluoro, N,N′-[1,6-hexanediylbis[(2-oxo-3,5- 306980–27–8 oxazolidinediyl)methylene]]bis[N-methyl-

P-96–1262 Sulfonic acids, C6-8-alkane, perfluoro, compds. with polyethylene-polypropylene glycol bis(2- 306974–45–8 aminopropyl) ether

P-96–1424 2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, telomer with 2-[ethyl[(perfluoro-C4- 306977–10–6 8-alkyl)sulfonyl]amino]ethyl methacrylate and 1-octanethiol, N-oxides

P-96–1433 1-Octanesulfonamide, N-[3-(dimethyloxidoamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- 178094–69–4 heptadecafluoro-,potassium salt

P-97–0790 1-Decanaminium, N-decyl-N,N-dimethyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- 251099–16–8 heptadecafluoro-1-octanesulfonic acid (1:1)

P-98–0251 2-Propenoic acid, butyl ester, polymers with acrylamide, 2-[methyl[(perfluoro-C4-8- 306978–04–1 alkyl)sulfonyl]amino]ethyl acrylate and vinylidene chloride

P-98–1272 2-Propenoic acid, 2-methyl-, 3-(trimethoxysilyl)propyl ester, polymers with acrylic acid, 2- 306977–58–2 [methyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl acrylate and propylene glycol monoacrylate, hydrolyzed, compds. with 2,2′-(methylimino)bis[ethanol]

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TABLE 2—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER JANUARY 1, 2003—Continued

CAS No./PMN CAS Ninth Collective Index Name

P-99–0188 Hexane, 1,6-diisocyanato-, homopolymer, N-(hydroxyethyl)-N-methyl perfluoro-C4-8-alkane 306978–65–4 sulfonamides- and stearyl alc.-blocked

P-99–0319 Poly(oxy-1,2-ethanediyl), .alpha.-[2-(methylamino)ethyl]-.omega.-[(1,1,3,3- 306979–40–8 tetramethylbutyl)phenoxy]-, N-[(perfluoro-C4-8-alkyl)sulfonyl] derivs.

TABLE 3—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER NOVEMBER 8, 2007

CAS No. CAS Sixteenth Collective Index Name

335–24–0 Cyclohexanesulfonic acid, 1,2,2,3,3,4,5,5,6,6-decafluoro-4-(1,1,2,2,2-pentafluoroethyl)-, potassium salt (1:1)

335–71–7 1-Heptanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-

335–77–3 1-Decanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heneicosafluoro-

335–97–7 1-Pentanesulfonamide, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-2-propen-1-yl-

355–03–3 Cyclohexanesulfonyl fluoride, 1,2,2,3,3,4,4,5,5,6,6-undecafluoro-

355–46–4 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-

375–81–5 1-Pentanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-

375–92–8 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-

423–86–9 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-2-propen-1-yl-

1869–77–8 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]-, ethyl ester

1893–52–3 2-Propenoic acid, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]amino]ethyl ester

2263–09–4 1-Octanesulfonamide, N-butyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-

2706–91–4 1-Pentanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-

2965–52–8 1-Octanesulfonamide, N,N′-[phosphinicobis(oxy-2,1-ethanediyl)]bis[N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-

2991–50–6 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]-

2991–52–8 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]-, ammonium salt (1:1)

3107–18–4 Cyclohexanesulfonic acid, 1,2,2,3,3,4,4,5,5,6,6-undecafluoro-, potassium salt (1:1)

3820–83–5 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[2- (phosphonooxy)ethyl]-

3871–50–9 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]-, sodium salt (1:1)

3871–99–6 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, potassium salt (1:1)

3872–25–1 1-Pentanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-, potassium salt (1:1)

13417–01–1 1-Octanesulfonamide, N-[3-(dimethylamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-

21055–88–9 Carbamic acid, N,N′-(4-methyl-1,3-phenylene)bis-, C,C′-bis[2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]amino]ethyl] ester

24924–36–5 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-2-propen-1-yl-

34455–03–3 1-Hexanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-(2-hydroxyethyl)-

37338–48–0 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]amino]ethyl]-.omega.-hydroxy-

38850–52–1 1-Propanaminium, 3-[(carboxymethyl)[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]amino]-N,N,N- trimethyl-, inner salt

38850–60–1 1-Propanesulfonic acid, 3-[[3-(dimethylamino)propyl][(1,1,2,2,3,3,4,4,5,5,6,6,6- tridecafluorohexyl)sulfonyl]amino]-

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TABLE 3—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER NOVEMBER 8, 2007— Continued

CAS No. CAS Sixteenth Collective Index Name

50598–28–2 1-Hexanesulfonamide, N-[3-(dimethylamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-

50598–29–3 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(phenylmethyl)-

51032–47–4 Benzenesulfonic acid, [[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]amino]methyl]-, sodium salt (1:1)

52032–20–9 Poly(oxy-1,2-ethanediyl), .alpha.-[[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]methylamino]carbonyl]-.omega.-butoxy-

52166–82–2 1-Propanaminium, N,N,N-trimethyl-3-[[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]amino]-, chloride (1:1)

52550–45–5 Poly(oxy-1,2-ethanediyl), .alpha.-[2-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]propylamino]ethyl]-.omega.-hydroxy-

55910–10–6 Glycine, N-[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]-N-propyl-, potassium salt (1:1)

56372–23–7 Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,6- tridecafluorohexyl)sulfonyl]amino]ethyl]-.omega.-hydroxy-

56773–42–3 Ethanaminium, N,N,N-triethyl-, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1-octanesulfonate (1:1)

58920–31–3 2-Propenoic acid, 4-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]methylamino]butyl ester

59071–10–2 2-Propenoic acid, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoroheptyl)sulfonyl]amino]ethyl ester

60270–55–5 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, potassium salt (1:1)

61577–14–8 2-Propenoic acid, 2-methyl-, 4-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]methylamino]butyl ester

66008–68–2 2-Propenoic acid, 2-[[(2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,11- eicosafluoroundecyl)sulfonyl]methylamino]ethyl ester

66008–69–3 2-Propenoic acid, 2-[[(2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluorononyl)sulfonyl]methylamino]ethyl ester

66008–70–6 2-Propenoic acid, 2-[methyl[(2,2,3,3,4,4,5,5,6,6,7,7,7-tridecafluoroheptyl)sulfonyl]amino]ethyl ester

67584–48–9 1-Hexanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-2-propen-1-yl-

67584–49–0 1-Heptanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-2-propen-1-yl-

67584–50–3 1-Heptanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-[3-(trichlorosilyl)propyl]-

67584–52–5 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]-, potassium salt (1:1)

67584–53–6 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]-, potassium salt (1:1)

67584–54–7 1-Heptanesulfonamide, N-[3-(dimethylamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-

67584–56–9 2-Propenoic acid, 2-[methyl[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]ethyl ester

67584–57–0 2-Propenoic acid, 2-[methyl[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]amino]ethyl ester

67584–58–1 1-Propanaminium, N,N,N-trimethyl-3-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]-, iodide (1:1)

67584–60–5 2-Propenoic acid, 2-methyl-, 2-[methyl[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]ethyl ester

67584–61–6 2-Propenoic acid, 2-methyl-, 2-[methyl[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]amino]ethyl ester

67584–62–7 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoroheptyl)sulfonyl]-, potassium salt (1:1)

67906–38–1 2-Propenoic acid, 2-methyl-, 4-[methyl[(1,1,2,2,3,3,4,4,5,5,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]butyl ester

463

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TABLE 3—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER NOVEMBER 8, 2007— Continued

CAS No. CAS Sixteenth Collective Index Name

67906–40–5 2-Propenoic acid, 2-methyl-, 4-[methyl[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]butyl ester

67906–41–6 1-Heptanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-2-propen-1-yl-

67906–70–1 2-Propenoic acid, 2-methyl-, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]amino]ethyl ester

67906–71–2 2-Propenoic acid, 2-methyl-, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]amino]ethyl ester, polymer with octadecyl 2-propenoate and 2-propenoic acid

67906–73–4 2-Propenoic acid, 2-methyl-, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]ethyl ester

67906–74–5 2-Propenoic acid, 2-methyl-, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]ethyl ester, polymer with octadecyl 2-propenoate and 2-propenoic acid

67923–61–9 1-Heptanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-[2-(phosphonooxy)ethyl]-

67939–36–0 2-Propenoic acid, 2-methyl-, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]ethyl ester

67939–37–1 2-Propenoic acid, 2-methyl-, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]ethyl ester, polymer with octadecyl 2-propenoate and 2-propenoic acid

67939–42–8 1-Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-[3- (trichlorosilyl)propyl]-

67939–61–1 2-Propenoic acid, 2-methyl-, 4-[methyl[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]amino]butyl ester

67939–87–1 1-Pentanesulfonamide, N,N′-[phosphinicobis(oxy-2,1-ethanediyl)]bis[N-ethyl-1,1,2,2,3,3,4,4,5,5,5- undecafluoro-

67939–88–2 1-Octanesulfonamide, N-[3-(dimethylamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, hydrochloride (1:1)

67939–90–6 1-Pentanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-[2-(phosphonooxy)ethyl]-

67939–92–8 1-Hexanesulfonamide, N,N′-[phosphinicobis(oxy-2,1-ethanediyl)]bis[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,6- tridecafluoro-

67939–93–9 1-Heptanesulfonamide, N,N′-[phosphinicobis(oxy-2,1-ethanediyl)]bis[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoro-

67939–94–0 1-Heptanesulfonamide, N,N′,N′-[phosphinylidynetris(oxy-2,1-ethanediyl)]tris[N-ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-

67939–96–2 2-Propenoic acid, 2-methyl-, 2-[methyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]ethyl ester

67939–97–3 1-Heptanesulfonamide, N,N′-[phosphinicobis(oxy-2,1-ethanediyl)]bis[N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoro-, ammonium salt (1:1)

67939–98–4 1-Heptanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-[2-(phosphonooxy)ethyl]-, ammonium salt (1:2)

67940–02–7 1-Heptanesulfonamide, N-[3-(dimethylamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, hydrochloride (1:1)

67969–65–7 1-Hexanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-[2-(phosphonooxy)ethyl]-

68081–83–4 Carbamic acid, N,N′-(4-methyl-1,3-phenylene)bis-, bis[2-[ethyl[(perfluoro-C4-8-alkyl)sulfonyl]amino]ethyl] ester

68084–62–8 2-Propenoic acid, 2-[methyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoroheptyl)sulfonyl]amino]ethyl ester

68156–00–3 Cyclohexanesulfonyl fluoride, nonafluorobis(trifluoromethyl)-

68156–06–9 Cyclohexanesulfonyl fluoride, decafluoro(1,1,2,2,2-pentafluoroethyl)-

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TABLE 3—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER NOVEMBER 8, 2007— Continued

CAS No. CAS Sixteenth Collective Index Name

68156–07–0 Cyclohexanesulfonic acid, decafluoro(trifluoromethyl)-, potassium salt (1:1)

68227–87–2 2-Propenoic acid, 2-methyl-, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]amino]ethyl ester, telomer with 2-[ethyl[(1,1,2,2,3,3,4,4,4- nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl

68227–94–1 2-Propenoic acid, 2-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]methylamino]ethyl ester, polymer with 2-[methyl[(1,1,2,2,3,3,4,4,4-nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, .alpha.-(2-methyl-1-oxo-2-propen-1-yl)-.omega.-hydroxypoly(oxy-1,2-ethanediyl), .alpha.-(2-methyl-1- oxo-2-propen-1-yl)-.omega.

68227–96–3 2-Propenoic acid, butyl ester, telomer with 2-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, 2-[methyl[(1,1,2,2,3,3,4,4,4- nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, .alpha.-(2-methyl-1-oxo-2-propen-1-yl)-.omega.- hydroxypoly(oxy-1,4-butanediyl), .alpha.-(2-methyl

68227–97–4 2-Propenoic acid, 4-[methyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoroheptyl)sulfonyl]amino]butyl ester

68227–98–5 2-Propenoic acid, 4-[methyl[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]amino]butyl ester

68227–99–6 2-Propenoic acid, 4-[methyl[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]butyl ester

68228–00–2 2-Propenoic acid, ethyl ester, polymer with 4-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]methylamino]butyl 2-propenoate, 4-[methyl[(1,1,2,2,3,3,4,4,4- nonafluorobutyl)sulfonyl]amino]butyl 2-propenoate, .alpha.-(2-methyl-1-oxo-2-propen-1-yl)-.omega.- hydroxypoly(oxy-1,4-butanediyl), .alpha.-(2-methyl

68239–72–5 1-Pentanesulfonamide, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(4-hydroxybutyl)-N-methyl-

68239–73–6 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(4-hydroxybutyl)-N-methyl-

68239–74–7 1-Hexanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-(4-hydroxybutyl)-N-methyl-

68239–75–8 1-Heptanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-[3-(trimethoxysilyl)propyl]-

68259–06–3 1-Nonanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-nonadecafluoro-

68259–07–4 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, ammonium salt (1:1)

68259–08–5 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, ammonium salt (1:1)

68259–09–6 1-Pentanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-, ammonium salt (1:1)

68259–12–1 1-Nonanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-nonadecafluoro-

68259–14–3 1-Heptanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-methyl-

68259–15–4 1-Hexanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-methyl-

68259–38–1 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,6- tridecafluorohexyl)sulfonyl]amino]ethyl]-.omega.-hydroxy-

68259–39–2 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]ethyl]-.omega.-hydroxy-

68298–06–6 2-Propenoic acid, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]ethyl ester

68298–08–8 1-Pentanesulfonamide, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(phenylmethyl)-

68298–09–9 1-Hexanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-(phenylmethyl)-

68298–10–2 1-Heptanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(phenylmethyl)-

68298–11–3 1-Propanaminium, 3-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl](3- sulfopropyl)amino]-N-(2-hydroxyethyl)-N,N-dimethyl-, inner salt

68298–13–5 1-Pentanesulfonamide, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-methyl-

68298–60–2 2-Propenoic acid, 2-[butyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoroheptyl)sulfonyl]amino]ethyl ester

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TABLE 3—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER NOVEMBER 8, 2007— Continued

CAS No. CAS Sixteenth Collective Index Name

68298–78–2 2-Propenoic acid, 2-methyl-, 2-[[[[5-[[[2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]amino]ethoxy]carbonyl]amino]-2-methylphenyl]amino]carbonyl]oxy]propyl ester, telomer with butyl 2-propenoate, 2-[[[[5-[[[2-[ethyl[(1,1,2,2,3,3,4,4,4- nonafluorobutyl)sulfonyl]amino]ethoxy]carbon

68298–80–6 Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]ethyl]- .omega.-hydroxy-

68298–81–7 Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]ethyl]-.omega.-hydroxy-

68298–89–5 1-Heptanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(4-hydroxybutyl)-N-methyl-

68299–20–7 Benzenesulfonic acid, [[[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]methyl]-, sodium salt (1:1)

68299–21–8 Benzenesulfonic acid, [[[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]amino]methyl]-, sodium salt (1:1)

68299–29–6 Benzenesulfonic acid, ar-[[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoroheptyl)sulfonyl]amino]methyl]-, sodium salt (1:1)

68299–39–8 2-Propenoic acid, 2-methyl-, 4-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]methylamino]butyl ester, telomer with butyl 2-propenoate, 2- [[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, 4- [methyl[(1,1,2,2,3,3,4,4,4-nonafluorobutyl)sulfonyl]amino]butyl 2-methyl-2-propeno

68310–02–1 1-Heptanesulfonamide, N-butyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-

68310–17–8 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[ethyl[(1,1,2,2,3,3,4,4,5,5,5- undecafluoropentyl)sulfonyl]amino]ethyl]-.omega.-hydroxy-

68310–75–8 1-Propanaminium, 3-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]amino]-N,N,N- trimethyl-, iodide, ammonium salt (1:1:1)

68318–34–3 Cyclohexanesulfonyl fluoride, decafluoro(trifluoromethyl)-

68318–36–5 1-Propanaminium, 3-[(carboxymethyl)[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]amino]-N,N,N-trimethyl-, inner salt

68391–09–3 Sulfonic acids, C6-12-alkane, perfluoro, potassium salts

68541–01–5 Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]oxy]phenyl]amino]carbonyl]-, potassium salt (1:1)

68541–02–6 Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3-[[(1,1,2,2,3,3,4,4,5,5,5- undecafluoropentyl)sulfonyl]oxy]phenyl]amino]carbonyl]-, potassium salt (1:1)

68555–69–1 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]-, sodium salt (1:1)

68555–70–4 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]-, sodium salt (1:1)

68555–71–5 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoroheptyl)sulfonyl]-, sodium salt (1:1)

68555–72–6 1-Pentanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(2-hydroxyethyl)-

68555–73–7 1-Heptanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-

68555–74–8 1-Pentanesulfonamide, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-N-(2-hydroxyethyl)-N-methyl-

68555–75–9 1-Hexanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-(2-hydroxyethyl)-N-methyl-

68555–76–0 1-Heptanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-N-(2-hydroxyethyl)-N-methyl-

68555–78–2 1-Pentanesulfonamide, N-[3-(dimethylamino)propyl]-1,1,2,2,3,3,4,4,5,5,5-undecafluoro-

68555–79–3 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]-, ethyl ester

68555–81–7 1-Propanaminium, N,N,N-trimethyl-3-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]-, chloride (1:1)

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TABLE 3—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER NOVEMBER 8, 2007— Continued

CAS No. CAS Sixteenth Collective Index Name

68568–77–4 2-Propenoic acid, 2-methyl-, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]amino]ethyl ester, polymer with 2-chloro-1,3-butadiene, 2- [ethyl[(1,1,2,2,3,3,4,4,4-nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2- [ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl

68608–13–9 Sulfonamides, C4-8-alkane, perfluoro, N-ethyl-N-(hydroxyethyl), reaction products with TDI

68797–76–2 2-Propenoic acid, 2-methyl-, 2-ethylhexyl ester, polymer with 2-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate, 2-[methyl[(1,1,2,2,3,3,4,4,4- nonafluorobutyl)sulfonyl]amino]ethyl 2-propenoate, 2-[methyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoa

68815–72–5 Benzoic acid, 2,3,4,5-tetrachloro-6-[[[3-[[(1,1,2,2,3,3,4,4,5,5,6,6,6- tridecafluorohexyl)sulfonyl]oxy]phenyl]amino]carbonyl]-, potassium salt (1:1)

68877–32–7 2-Propenoic acid, 2-methyl-, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]amino]ethyl ester, polymer with 2-[ethyl[(1,1,2,2,3,3,4,4,4- nonafluorobutyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-methyl-2-propenoate, 2-[ethyl

68891–97–4 Chromium, diaquatetrachloro[.mu.-[N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]glycinato-.kappa.O:.kappa.O′]]-.mu.-hydroxybis(2-propanol)-

68891–98–5 Chromium, diaquatetrachloro[.mu.-[N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,6- tridecafluorohexyl)sulfonyl]glycinato-.kappa.O:.kappa.O′]]-.mu.-hydroxybis(2-propanol)di-

68891–99–6 Chromium, diaquatetrachloro[.mu.-[N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,5- undecafluoropentyl)sulfonyl]glycinato-.kappa.O:.kappa.O′]]-.mu.-hydroxybis(2-propanol)di-

68957–31–3 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]-

68957–32–4 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]-

68957–53–9 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]-, ethyl ester

68957–54–0 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoroheptyl)sulfonyl]-, ethyl ester

68957–55–1 1-Propanaminium, N,N,N-trimethyl-3-[[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]-, chloride (1:1)

68957–57–3 1-Propanaminium, N,N,N-trimethyl-3-[[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]-, iodide (1:1)

68957–58–4 1-Propanaminium, N,N,N-trimethyl-3-[[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]amino]-, iodide (1:1)

68957–60–8 1-Pentanesulfonamide, N-[3-(dimethylamino)propyl]-1,1,2,2,3,3,4,4,5,5,5-undecafluoro-, hydrochloride (1:1)

68957–61–9 1-Hexanesulfonamide, N-[3-(dimethylamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, hydrochloride (1:1)

68957–62–0 1-Heptanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-

68957–63–1 Glycine, N-ethyl-N-[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoroheptyl)sulfonyl]-

68958–60–1 Poly(oxy-1,2-ethanediyl), .alpha.-[2-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]ethyl]-.omega.-methoxy-

70225–15–9 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, compd. with 2,2′-iminobis[ethanol] (1:1)

70225–16–0 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. with 2,2’-iminobis[ethanol] (1:1)

70225–17–1 1-Pentanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-, compd. with 2,2’-iminobis[ethanol] (1:1)

70225–20–6 1-Propanaminium, N,N,N-trimethyl-3-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- pentadecafluoroheptyl)sulfonyl]amino]-, sulfate (2:1)

70225–24–0 1-Propanaminium, N,N,N-trimethyl-3-[[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]-, sulfate (2:1)

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TABLE 3—PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER NOVEMBER 8, 2007— Continued

CAS No. CAS Sixteenth Collective Index Name

70225–26–2 1-Propanaminium, 3-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8,-heptadecafluorooctyl)sulfonyl]amino]-N,N,N- trimethyl-, sulfate (2:1)

70248–52–1 1-Propanaminium, N,N,N-trimethyl-3-[[(1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluorohexyl)sulfonyl]amino]-, sulfate (2:1)

70900–40–2 2-Propenoic acid, 2-methyl-, 2-[[[[5-[[[4-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]methylamino]butoxy]carbonyl]amino]-2- methylphenyl]amino]carbonyl]oxy]propyl ester, telomer with butyl 2-propenoate, 2- [[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate,

71463–74–6 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, compd. with piperidine (1:1)

71463–78–0 Phosphonic acid, P-[3-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]amino]propyl]-

71463–79–1 Phosphonic acid, P-[3-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoroheptyl)sulfonyl]amino]propyl]-

71463–80–4 Phosphonic acid, P-[3-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]amino]propyl]-, diethyl ester

71463–81–5 Phosphonic acid, P-[3-[ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoroheptyl)sulfonyl]amino]propyl]-, diethyl ester

72785–08–1 1-Propanesulfonic acid, 3-[[3-(dimethylamino)propyl][(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]amino]-

73018–93–6 2-Propenoic acid, 2-methyl-, 2-ethylhexyl ester, polymer with 2-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]methylamino]ethyl 2-propenoate

73019–19–9 Benzamide, 4-[[4-[[[2-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]propylamino]ethyl]amino]carbonyl]phenyl]methyl]-N-octadecyl-

73019–20–2 1,3-Benzenedicarboxamide, N3-[2-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]methylamino]ethyl]-N1-[2-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluorooctyl)sulfonyl]propylamino]ethyl]-4-methyl-

73019–28–0 2-Propenoic acid, 2-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]propylamino]ethyl ester, polymer with .alpha.-(2-methyl-1-oxo-2-propen-1-yl)-.omega.-methoxypoly(oxy-1,2-ethanediyl)

73038–33–2 2-Propenoic acid, 2-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]propylamino]ethyl ester, polymer with 2-methyloxirane polymer with oxirane mono(2-methyl-2-propenoate)

73275–59–9 2-Propenoic acid, 2-[[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]propylamino]ethyl ester, polymer with .alpha.-(2-methyl-1-oxo-2-propen-1-yl)-.omega.-butoxypoly[oxy(methyl-1,2- ethanediyl)]

73772–33–5 1-Hexanesulfonamide, N-[3-(dimethylamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, acetate (1:1)

73772–34–6 1-Hexanesulfonamide, N-[3-(dimethylamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-N-[2-[2-(2- hydroxyethoxy)ethoxy]ethyl]-

95590–48–0 2-Propenoic acid, 2-methyl-, 3-(trimethoxysilyl)propyl ester, polymer with ethenylbenzene, 2- [ethyl[(1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctyl)sulfonyl]amino]ethyl 2-propenoate and 2- hydroxyethyl 2-propenoate

148240–81–7 Fatty acids, C18-unsatd., trimers, 2-[methyl[(1,1,2,2,3,3,4,4,5,5,5-undecafluoropentyl)sulfonyl]amino]ethyl esters

179005–06–2 Sulfonamides, C4-8-alkane, perfluoro, N-[3-(dimethyloxidoamino)propyl], potassium salts

(2) The significant new uses are: (ii) Any manufacture or import for (i) Any manufacture or import for any use of any chemical substance list- any use of any chemical substance listed in Table 2 of paragraph (a)(1) of this ed in Table 1 of paragraph (a)(1) of this section, except as noted in paragraph section. (a)(3) of this section.

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(iii) Any manufacture or import for 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- any use of any chemical substance list- pentadecafluoro-,ammonium salt (CAS ed in Table 3 of paragraph (a)(1) of this No. 68259–07–4); 1-Heptanesulfonamide, section, except as noted in paragraphs N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7- (a)(3) through (a)(5) of this section. pentadecafluoro- (CAS No. 68957–62–0); (3) Manufacture or import of any Poly(oxy-1,2-ethanediyl), .alpha.-[2- chemical substance listed in Table 2 [ethyl[(pentadecafluoroheptyl)sulfonyl] and Table 3 of paragraph (a)(1) of this amino]ethyl]-.omega.-methoxy- (CAS section for the following specific uses No. 68958–60–1); or 1-Hexanesulfonic shall not be considered as a significant acid, 1,1,2,2,3,3,4,4,5,5,6,6,6- new use subject to reporting under this tridecafluoro-, compd. with 2,2′- section: iminobis[ethanol] (1:1) (CAS No. 70225– (i) Use as an anti-erosion additive in 16–0) for use as a component of an fire-resistant phosphate ester aviation etchant, including a surfactant or fume hydraulic fluids. suppressant, used in the plating proc- (ii) Use as a component of a ess to produce electronic devices shall photoresist substance, including a not be considered a significant new use photo acid generator or surfactant, or subject to reporting under this section. as a component of an anti-reflective (b) [Reserved] coating, used in a photomicrolithography process to [67 FR 72863, Dec. 9, 2002, as amended at 72 produce semiconductors or similar FR 57229, Oct. 9, 2007] components of electronic or other min- iaturized devices. § 721.9595 Alkyl benzene sulfonic acids (iii) Use in coating for surface ten- and alkyl sulfates, amine salts (generic). sion, static discharge, and adhesion control for analog and digital imaging (a) Chemical substance and significant films, papers, and printing plates, or as new uses subject to reporting. (1) The a surfactant in mixtures used to proc- chemical substances identified generi- ess imaging films. cally as alkyl benzene sulfonic acids (iv) Use as an intermediate only to and alkyl sulfates, amine salts (PMNs produce other chemical substances to P-97–296/297/298/299) are subject to re- be used solely for the uses listed in porting under this section for the sig- paragraph (a)(3)(i), (ii), or (iii) of this nificant new uses described in para- section. graph (a)(2) of this section. (4) Manufacture or import of (2) The significant new uses are: tetraethylammonium (i) Release to water. Requirements as perfluorooctanesulfonate (CAS No. specified in § 721.90 (a)(1), (b)(1), and 56773–42–3) for use as a fume/mist sup- (c)(1). pressant in metal finishing and plating (ii) [Reserved] baths shall not be considered as a sig- (b) Specific requirements. The provi- nificant new use subject to reporting sions of subpart A of this part apply to under this section. Examples of such this section except as modified by this metal finishing and plating baths in- paragraph. clude: Hard chrome plating; decorative (1) Recordkeeping. Recordkeeping re- chromium plating; chromic acid anod- quirements as specified in § 721.125 (a), izing; nickel, cadmium, or lead plating; (b), (c), and (k) are applicable to manu- metal plating on plastics; and alkaline facturers, importers, and processors of zinc plating. these substances. (5) Manufacture or import of: 1- (2) Limitations or revocation of certain Pentanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,5- notification requirements. The provisions undecafluoro-, potassium salt (CAS No. of § 721.185 apply to this section. 3872–25–1); Glycine, N-ethyl-N- [(tridecafluorohexyl)sulfonyl]-, potas- [63 FR 44582, Aug. 20, 1998] sium salt (CAS No. 67584–53–6); Glycine, N-ethyl-N- § 721.9597 Salt of a substituted sulfo- [(pentadecafluoroheptyl)sulfonyl]-, po- nated aryl azo compound (generic). tassium salt (CAS No. 67584–62–7); 1- (a) Chemical substance and significant Heptanesulfonic acid, new uses subject to reporting. (1) The

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chemical substance identified generically as polyfluorosulfonic acid salt (P- cally as salt of a substituted sulfonated 90–587) is subject to reporting under aryl azo compound (PMN P-00–0094) is this section for the significant new subject to reporting under this section uses described in paragraph (a)(2) of for the significant new use described in this section. paragraph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial, and con- (i) Industrial, commercial, and consumer activities. Requirements as speci- sumer activities. Requirements as specified in § 721.80(y) (1) and (2). fied in § 721.80 (f). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping requirements. The (1) Recordkeeping. Recordkeeping re- following recordkeeping requirements quirements as specified in § 721.125 (a), are applicable to manufacturers, im- (b), (c), and (i) are applicable to manu- porters, and processors of this sub- facturers, importers, and processors of stance, as specified in § 721.100 (a), (b), this substance. (c), and (i). (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [68 FR 15089, Mar. 28, 2003] [56 FR 15793, Apr. 17, 1991. Redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR § 721.9620 Aromatic sulfonic acid com- 34204, June 23, 1993] pound with amine. § 721.9635 Terpene residue distillates. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified generically as aromatic sulfonic acid com- cally as terpene residue distillates pound with amine (PMN P-93–832) is (PMN P-96–897) is subject to reporting subject to reporting under this section under this section for the significant for the significant new uses described new uses described in paragraph (a)(2) in paragraph (a)(2) of this section. of this section. (2) The significant new uses are: (i) (2) The significant new uses are: Release to water. Requirements as speci- (i) Release to water. Requirements as fied in § 721.90 (a)(4), (b)(4), and (c)(4) specified in § 721.90 (a)(4), (b)(4), and (where N = 30 ppb). (c)(4) (N = 10). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [58 FR 51709, Oct. 4, 1993] [63 FR 3438, Jan. 22, 1998]

§ 721.9630 Polyfluorosulfonic acid salt. § 721.9640 Salt of an acrylic acid – ac- (a) Chemical substance and significant rylamide terpolymer (generic). new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The

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chemical substance identified generi- chemical substance identified generically as salt of an acrylic acid – acryl- cally as a thiaalkanethiol (PMN P-94– amide terpolymer (PMN P-99–817) is 1487) is subject to reporting under this subject to reporting under this section section for the significant new uses de- for the significant new use described in scribed in paragraph (a)(2) of this sec- paragraph (a)(2) of this section. tion. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial, and con- (i) Release to water. Requirements as sumer activities. Requirements as speci- specified in § 721.90 (a)(1), (b)(1), and fied in § 721.80(v)(2), (w)(2), and (x)(2). (c)(1). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this chemical substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [68 FR 70183, Dec. 17, 2003] [60 FR 45084, Aug. 30, 1995]

§ 721.9650 Tetramethylammonium salts § 721.9657 Disubstituted thiadiazole. of alkylbenzenesulfonic acid. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified generically as a disubstituted thiadiazole cally as tetramethylammonium salts (PMN P-97–314) is subject to reporting of alkylbenzenesulfonic acid (PMN P- under this section for the significant 92–1364) is subject to reporting under new uses described in paragraph (a)(2) this section for the significant new of this section. uses described in paragraph (a)(2) of (2) The significant new uses are: this section. (i) Industrial, commercial, and con- (2) The significant new uses are: sumer activities. Requirements as speci- (i) Release to water. Requirements as fied in § 721.80 (a),(b), (c), and (j). specified in § 721.90 (a)(4), (b)(4), and (ii) [Reserved] (c)(4) (where N = 80 ppb). (b) Specific requirements. The provi- (ii) [Reserved] sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), and (i) are applicable to manu- quirements as specified in § 721.125 (a), facturers, importers, and processors of (b), (c), and (k) are applicable to manu- this substance. facturers, importers, and processors of (2) Limitations or revocation of certain this substance. notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions [63 FR 3438, Jan. 22, 1998] of § 721.185 apply to this section. [58 FR 51687, Oct. 4, 1993] § 721.9658 Thiadiazole derivative. (a) Chemical substance and significant § 721.9656 Thiaalkanethiol. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified as a new uses subject to reporting. (1) The thiadiazole derivative (PMN P-94–1631)

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is subject to reporting under this sec- chemical substance methylthiouracil tion for the significant new uses de- (CAS No. 56–04–2) is subject to report- scribed in paragraph (a)(2) of this sec- ing under this section for the signifi- tion. cant new use described in paragraph (2) The significant new uses are: (a)(2) of this section. (i) Industrial, commercial, and con- (2) The significant new use is: Manu- sumer activities. Requirements as speci- facture, import, or processing of 10,000 fied in § 721.80 (a), (c), (f), (v)(1), (w)(1), pounds or more per year per facility for and (x)(1). any use. (ii) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(4), (b)(4), and sions of subpart A of this part apply to (c)(4) (where n = 90). this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. The following rec- this section except as modified by this ordkeeping requirements are applicable paragraph. to manufacturers, importers, and proc- (1) Recordkeeping. Recordkeeping re- essors of this substance, as specified in quirements as specified in § 721.125 (a), (b), (c), (i), and (k) are applicable to § 721.125 (a), (b), and (c). manufacturers, importers, and proc- (2) [Reserved] essors of this substance. [58 FR 63517, Dec. 1, 1993] (2) Limitations or revocation of certain notification requirements. The provisions § 721.9661 Diphenol tars (generic). of § 721.185 apply to this section. (a) Chemical substance and significant [60 FR 45085, Aug. 30, 1995] new uses subject to reporting. (1) The chemical substance identified generi- § 721.9659 Disubstituted cally as diphenol tars (PMN P-97–813) is thiadiazosulfone. subject to reporting under this section (a) Chemical substance and significant for the significant new uses described new uses subject to reporting. (1) The in paragraph (a)(2) of this section. chemical substance identified generi- (2) The significant new uses are: cally as a disubstituted (i) Industrial, commercial, and con- thiadiazosulfone (PMN P-97–304) is sub- sumer activities. Requirements as speci- ject to reporting under this section for fied in § 721.80(j). the significant new uses described in (ii) [Reserved] paragraph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80 (a),(b), (c), and (j). (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), and (k) are applicable to manu- this section except as modified by this facturers, importers, and processors of paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (i) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of [63 FR 44582, Aug. 20, 1998] this substance. (2) Limitations or revocation of certain § 721.9662 Thieno[3,4-b]-1,4-dioxin, 2,3- notification requirements. The provisions dihydro- (9CI). of § 721.185 apply to this section. (a) Chemical substance and significant [63 FR 3438, Jan. 22, 1998] new uses subject to reporting. (1) The chemical substance identified as § 721.9660 Methylthiouracil. thieno[3,4-b]-1,4-dioxin, 2,3-dihydro- (a) Chemical substance and significant (9CI) (PMN P-95–1825; CAS No. 126213– new use subject to reporting. (1) The 50–1) is subject to reporting under this

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section for the significant new uses de- § 721.9664 9H-Thioxanthen-9-one,2,4- scribed in paragraph (a)(2) of this sec- diethyl. tion. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Protection in the workplace. Re- chemical substance identified as 9H- quirements as specified in § 721.63 (a)(1) thioxanthen-9-one,2,4-diethyl (PMN P- and (a)(2)(i). 96–1315; CAS No. 82799–44–8) is subject (ii) Industrial, commercial, and con- to reporting under this section for the sumer activities. Requirements as speci- significant new uses described in para- fied in § 721.80(f). graph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified in § 721.90 (a)(4), (b)(4), and paragraph. (c)(4) (N = 1). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), (d), (e), and (k) are applicable sions of subpart A of this part apply to to manufacturers, importers, and proc- this section except as modified by this essors of this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (k) are applicable to manufacturers, importers, and processors of [63 FR 3439, Jan. 22, 1998; 63 FR 9441, Feb. 25, 1998] this substance. (2) Limitations or revocation of certain § 721.9663 Poly(oxy-1,2-ethanediyl), notification requirements. The provisions alpha, alpha′-[thiobis (1-oxo-3,1- of § 721.185 apply to this section. propanediyl)]bis [omega-hydroxy- [63 FR 3439, Jan. 22, 1998] ,bis (C11-15 and C11-15-isoalkyl) ethers. (a) Chemical substance and significant § 721.9665 Organotin catalysts. new uses subject to reporting. (1) The (a) Chemical substances and significant chemical substance identified as new uses subject to reporting. (1) The poly(oxy-1,2-ethanediyl), alpha, alpha′- chemical substances identified generi- [thiobis (1-oxo-3,1-propanediyl)]bis cally as organotin catalysts (PMNs P- [omega-hydroxy-,bis(C11–15 and 93–853, P-93–854, P-93–855, P-93–856, P-93– C11–15–isoalkyl) ethers (PMN P-97–497; CAS 857, and P-93–858) are subject to report- No. 174254–18–3) is subject to reporting ing under this section for the signifi- under this section for the significant cant new uses described in paragraph new uses described in paragraph (a)(2) (a)(2) of this section. of this section. (2) The significant new uses are: (i) (2) The significant new uses are: Industrial, commercial and consumer ac- (i) Industrial, commercial, and con- tivities. Requirements as specified in sumer activities. Requirements as speci- § 721.80 (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), fied in § 721.80(j). and (x)(2). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. The recordkeeping (1) Recordkeeping. Recordkeeping re- requirements specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- (b), (c), and (i) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [63 FR 44582, Aug. 20, 1998] [58 FR 51709, Oct. 4, 1993]

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§ 721.9668 Organotin lithium com- § 721.9671 Triaryltin (generic). pound. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance generically identically as a Triaryltin (PMN P-99–0199) is fied as an organotin lithium compound subject to reporting under this section (PMN P-93–1119) is subject to reporting for the significant new use described in under this section for the significant paragraph (a)(2) of this section. new uses described in paragraph (a)(2) (2) The significant new uses are: of this section. (i) Industrial, commercial, and con- (2) The significant new uses are: sumer activities. Requirements as speci- (i) Release to water. Requirements as fied in § 721.80(g). specified in § 721.90 (a)(4), (b)(4), and (ii) Release to water. Requirements as (c)(4) (N = 1). specified § 721.90 (a)(4), (b)(4), and (c)(4) (ii) [Reserved] (N=1 ppb). (b) Specific requirements. The provisions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), and (k) are applicable to manu- quirements as specified in § 721.125 (a), facturers, importers, and processors of (b), (c), (i), and (k) are applicable to this substance. manufacturers, importers, and proc- (2) Limitations or revocation of certain essors of this substance. notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions of § 721.185 apply to this section. [63 FR 9450, Feb. 25, 1998] [65 FR 81404, Dec. 26, 2000] § 721.9670 Tetraaryltin (generic). (a) Chemical substance and significant § 721.9672 Amides, tall-oil fatty, N-[2-[2- hydroxyethyl)amino]ethyl], reaction new uses subject to reporting. (1) The products with sulfur dioxide; fatty chemical substance identified generi- acids, tall-oil, reaction products cally as a Tetraaryltin (PMN P-99–0198) with 1-piperazineethanamine and is subject to reporting under this sec- sulfur dioxide; fatty acids, tall-oil tion for the significant new use de- reaction products with sulfur diox- scribed in paragraph (a)(2) of this sec- ide and triethylenetetramine. tion. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Industrial, commercial, and con- chemical substance identified as am- sumer activities. Requirements as speci- ides, tall-oil fatty, N-[2-[2-hydroxy- fied in § 721.80(g). ethyl)amino]ethyl], reaction products (ii) Release to water. Requirements as with sulfur dioxide; fatty acids, tall- specified § 721.90 (a)(4), (b)(4), and (c)(4) oil, reaction products with 1- (N=1 ppb). piperazineethanamine and sulfur diox- (b) Specific requirements. The provi- ide; fatty acids, tall-oil reaction prod- sions of subpart A of this part apply to ucts with sulfur dioxide and this section except as modified by this triethylenetetramine (PMN P-98–725; paragraph. CAS Nos. 202483–48–5, 203809–20–5, and (1) Recordkeeping. Recordkeeping re- 204401–83–2) is subject to reporting quirements as specified in § 721.125 (a), under this section for the significant (b), (c), (i), and (k) are applicable to new use described in paragraph (a)(2) of manufacturers, importers, and proc- this section. essors of this substance. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Release to water. Requirements as notification requirements. The provisions specified in § 721.90 (a)(1), (b)(1), and of § 721.185 apply to this section. (c)(1). [65 FR 81404, Dec. 26, 2000] (ii) [Reserved]

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(b) Specific requirements. The provi- (i) Hazard communication program. Re- sions of subpart A of this part apply to quirements as specified in § 721.72 (a), this section except as modified by this (b), (c), (d), (f), (g)(1)(ii), (g)(1)(vii), paragraph. (g)(2)(ii), and (g)(5). (1) Recordkeeping. Recordkeeping re- (ii) Industrial, commercial, and con- quirements as specified in § 721.125 (a), sumer activities. Requirements as speci- (b), (c), and (k) are applicable to manu- fied in § 721.80 (f), (l), and (q). In addi- facturers, importers, and processors of tion, a significant new use of the sub- this substance. stance is importation of the PMN sub- (2) Limitations or revocation of certain stance if: notification requirements. The provisions (A) Manufactured by other than the of § 721.185 apply to this section. method described in premanufacture [65 FR 373, Jan. 5, 2000] notice P-90–226. (B) The bulk density measurements § 721.9674 Sulfonated-copper of the PMN substance in the pure form phthalocyanine salt of a triaryl- are less than 0.4 g/cm3 or greater than methane dye (generic). 0.6 g/cm3. The bulk density of each (a) Chemical substance and significant shipment must be verified, by lot, prior new uses subject to reporting. (1) The to clearing U.S. customs. chemical substance identified generi- (b) Specific requirements. The provi- cally as sulfonated-copper sions of subpart A of this part apply to phthalocyanine salt of a triaryl- this section. methane dye (PMN P-00–1055) is subject (1) Recordkeeping. The following rec- to reporting under this section for the ordkeeping requirements are applicable significant new use described in para- to manufacturers, importers, and proc- graph (a)(2) of this section. essors of this substance as specified in (2) The significant new uses are: § 721.125 (a), (b), (c), (f), (g), (h), and (i). (i) Industrial, commercial, and con- In addition, records shall be kept iden- sumer activities. Requirements as speci- tifying the foreign supplier and docu- fied in § 721.80(v)(1), (w)(1), and (x)(1). menting, by lot, for each shipment, the (ii) Release to water. Requirements as method of manufacture and bulk den- specified in § 721.90(a)(4), (b)(4), and sity measurements. (c)(4) (N=1). (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this significant new this section except as modified by this use rule. paragraph. (3) Determining whether a specific use is (1) Recordkeeping. Recordkeeping re- subject to this section. The provisions of quirements as specified in § 721.125(a), § 721.1725(b)(1) apply to this section. (b), (c), (i), and (k) are applicable to [56 FR 40215, Aug. 13, 1991. Redesignated and manufacturers, importers, and proc- amended at 58 FR 29946, 29947, May 24, 1993; 58 essors of this chemical substance. FR 34204, June 23, 1993] (2) Limitations or revocation of certain notification requirements. The provisions § 721.9680 Alkaline titania silica gel of § 721.185 apply to this section. (generic name). [68 FR 70183, Dec. 17, 2003] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.9675 Titanate [Ti6O13 (2-)], dipo- chemical substance identified generi- tassium. cally as an alkaline titania silica gel (a) Chemical substance and significant (PMN P-95–529) is subject to reporting new uses subject to reporting. (1) The under this section for the significant chemical substance identified as tita- new uses described in paragraph (a)(2) nate [Ti6O13 (2-)], dipotassium (CAS No. of this section. 12056–51–8) (PMN P-90–0226) is subject to (2) The significant new uses are: reporting under this section for the sig- (i) Industrial, commercial, and con- nificant new uses described in para- sumer activities. Requirements as speci- graph (a)(2) of this section. fied in § 721.80 (v)(1), (w)(1), and (x)(1). (2) The significant new uses are: (ii) [Reserved]

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(b) Specific requirements. The provi- and (a)(3), (b) [concentration set at 0.1 sions of subpart A of this part apply to percent], and (c). this section except as modified by this (B) Hazard communication program. paragraph. Requirements as specified in § 721.72 (1) Recordkeeping. Recordkeeping re- (b)(2), (d), (e) [concentration set at 0.1 quirements as specified in § 721.125 (a), percent], (f), and (g)(1)(iv), (g)(1)(vii), (b), (c), and (i) are applicable to manu- and (g)(1)(viii), (g)(2)(i) and (g)(2)(v), facturers, importers, and processors of (g)(4)(xi), and (g)(5). The provisions of these substances. § 721.72(d) requiring employees to be (2) Limitations or revocation of certain provided with information on the loca- notification requirements. The provisions tion and availability of a written haz- of § 721.185 apply to this significant new ard communication program and use rule. MSDSs do not apply when the written program and MSDS are not required [61 FR 63740, Dec. 2, 1996] under § 721.72 (a) and (c), respectively. The provision of § 721.72(g) requiring § 721.9685 Mixed trialkylamines (ge- placement of specific information on a neric). MSDS does not apply when a MSDS is (a) Chemical substance and significant not required under § 721.72(c). new uses subject to reporting. (1) The (C) Industrial, commercial, and con- chemical substances identified generi- sumer activities. Requirements as speci- cally as mixed trialkylamines (PMNs fied in § 721.80(k). P-97–943/944/945/946/947/948) are subject (D) Disposal. Requirements as speci- to reporting under this section for the fied in § 721.85 (a)(1) and (a)(2) and (b)(1) significant new uses described in para- and (b)(2). graph (a)(2) of this section. (E) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(4) [concern level (i) Release to water. Requirements as of 10 ppb], (b)(4) [concern level of 10 specified in § 721.90 (a)(1), (b)(1), and ppb], and (c)(4) [concern level of 10 (c)(1). ppb]. (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (2) The chemical substance sions of subpart A of this part apply to monosubstituted alkoxyaminotrazines this section except as modified by this (PMN P-86–1044) is subject to reporting paragraph. under this section for the significant (1) Recordkeeping. Recordkeeping renew uses described in paragraph quirements as specified in § 721.125 (a), (a)(2)(i) of this section. (b), (c), and (k) are applicable to manu- (i) The significant new uses are: facturers, importers, and processors of (A) Protection in the workplace. Re- these substances. quirements as specified in § 721.63 (a)(1), (2) Limitations or revocation of certain (a)(3), (a)(4), (a)(5)(iii) through notification requirements. The provisions (a)(5)(vii), and (a)(6)(i), (b) [concentra- of § 721.185 apply to this section. tion set at 0.1 percent], and (c). (B) Hazard communication program. [63 FR 44583, Aug. 20, 1998] Requirements as specified in § 721.72 (b)(2), (d), (e) [concentration set at 0.1 § 721.9700 Monosubstituted alkoxy- percent], (f), and (g)(1)(iv), (g)(1)(vii), aminotrazines (generic name). and (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (a) Chemical substances and significant (g)(2)(iv), and (g)(2)(v), (g)(4)(xi), and new uses subject to reporting. (1) The (5). The provisions of § 721.72(d) requir- chemical substance monosubstituted ing employees to be provided with in- alkoxyaminotrazines (PMN P-86–1043) formation on the location and avail- is subject to reporting under this sec- ability of a written hazard communication for the significant new uses de- tion program and MSDSs do not apply scribed in paragraph (a)(1)(i) of this when the written program and MSDS section. are not required under § 721.72 (a) and (i) The significant new uses are: (c), respectively. The provision of (A) Protection in the workplace. Re- § 721.72(g) requiring placement of spe- quirements as specified in § 721.63 (a)(1) cific information on a MSDS does not

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apply when a MSDS in not required (2) Limitations or revocation of certain under § 721.72(c). notification requirements. The provisions (C) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as speci- [63 FR 3439, Jan. 22, 1998] fied in § 721.80(k). (D) Disposal. Requirements as speci- § 721.9719 Tris carbamoyl triazine (ge- fied in § 721.85 (a)(1) and (a)(2) and (b)(1) neric). and (b)(2). (a) Chemical substance and significant (E) Release to water. Requirements as new uses subject to reporting. (1) The specified in § 721.90 (a)(4) [concern level chemical substance identified generi- of 1 ppb], (b)(4) [concern level of 1 ppb], cally as tris carbamoyl triazine (PMN and (c)(4) [concern level of 1 ppb]. P-95–1098) is subject to reporting under (ii) [Reserved] this section for the significant new (b) Specific requirements. The provi- uses described in paragraph (a)(2) of sions of subpart A of this part apply to this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Hazard communication program. Re- (1) Recordkeeping. The following rec- quirements as specified in § 721.72 (a), ordkeeping requirements are applicable (b), (c), (d), (e) (concentration set at 1.0 to manufacturers, importers, and proc- percent), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), essors of this substance, as specified in and (g)(5). § 721.125 (a) through (k). (ii) Industrial, commercial, and con- (2) Limitations or revocation of certain sumer activities. Requirements as speci- notification requirements. The provisions fied in § 721.80(q). of § 721.185 apply to this significant new (iii) Release to water. Requirements as use rule. specified in § 721.90 (a)(4), (b)(4), and (3) Determining whether a specific use is (c)(4) (N = 40). subject to this section. The provisions of (b) Specific requirements. The provi- § 721.1725(b)(1) apply to this section. sions of subpart A of this part apply to this section except as modified by this [55 FR 26108, June 26, 1990. Redesignated and paragraph. amended at 58 FR 29946, May 24, 1993; 58 FR (1) Recordkeeping. Recordkeeping re- 34204, June 23, 1993] quirements as specified in § 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are ap- § 721.9717 Azo monochloro triazine re- plicable to manufacturers, importers, active dye. and processors of this substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance identified generi- of § 721.185 apply to this section. cally as an azo monochloro triazine re- (3) Determining whether a specific use is active dye (PMN P-96–238) is subject to subject to this section. The provisions of reporting under this section for the sig- § 721.1725(b)(1) apply to this section. nificant new uses described in paragraph (a)(2) of this section. [63 FR 44583, Aug. 20, 1998; 63 FR 62956, Nov. 10, 1998] (2) The significant new uses are: (i) Industrial, commercial, and con- § 721.9720 Disubstituted alkyl triazines sumer activities. Requirements as speci- (generic name). fied in § 721.80 (v)(2), (w)(2), and (x)(2). (a) Chemical substances and significant (ii) [Reserved] new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substances identified generi- sions of subpart A of this part apply to cally as disubstituted alkyl triazines this section except as modified by this (PMNs P-85–932 and P-85–933) are subparagraph. ject to reporting under this section for (1) Recordkeeping. Recordkeeping re- the significant new uses described in quirements as specified in § 721.125 (a), paragraph (a)(2) of this section. (b), (c), and (i) are applicable to manu- (2) The significant new uses are: facturers, importers, and processors of (i) Protection in the workplace. Re- this substance. quirements as specified in § 721.63 (a)(1),

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(a)(3), (a)(4), (a)(5)(iv), (a)(6)(i), (b) (con- (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), centration set at 0.1 percent), and (c). (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (ii) Hazard communication program. (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). Requirements as specified in § 721.72 (a), (iii) Industrial, commercial, and con- (b)(1), (d), (e) (concentration set at 0.1 sumer activities. Requirements as speci- percent), (f), (g)(1)(iv), (g)(1)(viii), fied in § 721.80(q). (g)(2)(i), (g)(2)(ii), (g)(2)(iv), and (iv) Disposal. Requirements as speci- (g)(2)(v). The provision of § 721.72(d) re- fied in § 721.85 as thus amended: It is a quiring that employees be provided significant new use to dispose of the with information on the location and process or use stream associated with availability of MSDSs does not apply any use of the substance or with any when an MSDS is not required under manner or method of manufacturing § 721.72(c). The provision of § 721.72(g) associated with any use of the sub- requiring placement of specific infor- stance by landfill. mation on an MSDS does not apply (v) Release to water. Requirements as when an MSDS is not required under specified in § 721.90(a)(4) (where N = 1). § 721.72(c). (b) Specific requirements. The provi- (iii) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Requirements as speci- this section except as modified by this fied in § 721.80(g). paragraph. (iv) Release to water. § 721.90 (a)(1), (1) Recordkeeping. Recordkeeping re- (b)(1), and (c)(1). quirements as specified in § 721.125 (a) (b) Specific requirements. The provi- through (k) are applicable to manufac- sions of subpart A of this part apply to turers, importers, and processors of this section except as modified by this this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. The following rec- notification requirements. The provisions ordkeeping requirements are applicable of § 721.185 apply to this significant new to manufacturers, importers, and proc- use rule. essors of this substance, as specified in (3) Determining whether a specific use is § 721.125 (a) through (i) and (k). subject to this section. The provisions of (2) Limitations or revocation of certain § 721.1725(b)(1) apply to this section. notification requirements. The provisions [58 FR 32241, June 8, 1993, as amended at 58 of § 721.185 apply to this section. FR 29946, May 24, 1993] [55 FR 26101, June 26, 1990. Redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR § 721.9740 Brominated triazine deriva- 34204, June 23, 1993] tive. (a) Chemical substance and significant § 721.9730 1,3,5-Triazin-2-amine, 4-di- new uses subject to reporting. (1) The methylamino-6-substituted-. chemical substance identified generi- (a) Chemical substance and significant cally as a brominated triazine deriva- new uses subject to reporting. (1) The tive (PMN P-91–403) is subject to re- chemical substances generically identi- porting under this section for the sig- fied as 1,3,5-triazin-2-amine, 4-dimeth- nificant new uses described in para- ylamino-6-substituted- (PMN Nos. P- graph (a)(2) of this section. 92–343 and P-92–344) are subject to re- (2) The significant new uses are: porting under this section for the sig- (i) Protection in the workplace. Re- nificant new uses described in para- quirements as specified in § 721.63 (a)(4), graph (a)(2) of this section. (a)(5)(iv), (a)(6)(i), (b) (concentration (2) The significant new uses are: set at 0.1 percent), and (c). (i) Protection in the workplace. Re- (ii) Hazard communication program. quirements as specified in § 721.63 (a)(1), Requirements as specified in § 721.72 (a), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (b), (c), (d), (e) (concentration set at 0.1 (a)(4), (a)(5)(i), (a)(6)(i), (b) (concentra- percent), (f), (g)(1)(iv), (g)(1)(vi), tion set at 0.1 percent), and (c). (g)(1)(vii), (g)(2)(iv), and (g)(5). The haz- (ii) Hazard communication program. ard communication requirements do Requirements as specified in § 721.72 (a), not apply when the chemical substance (b), (c), (d), (e) (concentration set at 0.1 is present in a plastic, elastomer, rub- percent), (f), (g)(1)(iii), (g)(1)(iv), ber matrix, or in solution.

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(iii) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in section 721.80(q). Any amount of (1) Recordkeeping. Recordkeeping re- the PMN substance imported in a plas- quirements as specified in § 721.125 (a), tic, elastomer, rubber matrix, or in a (b), (c), (f), (g), (h), (j), and (k) are ap- solution, such that inhalation is pre- plicable to manufacturers, importers, cluded, shall not be included in the pro- and processors of this substance. duction limit calculations. (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this paragraph. [59 FR 27485, May 27, 1994] (1) Recordkeeping requirements. Re- ′ quirements as specified in § 721.125 (a) § 721.9790 Benzenesulfonic acid, 2,2 - through (d) and (f) through (i) are ap- (1,2-ethenediyl)bis[5-[[4-[bis(2- hydroxypropyl) amino]- 6-[(3- plicable to manufacturers, importers, sulfophenyl)amino]-1,3,5-triazin-2- and processors of this substance. yl]amino]-, disodium salt, compd. (2) Limitations or revocation of certain with 2,2′,2″-nitrilo-tris[ethanol] (1:2); notification requirements. The provisions Benzenesulfonic acid, 5-[[4-[bis(2- of § 721.185 apply to this section. hydroxyethyl)amino]-6-[(3- (3) Determining whether a specific use is sulfophenyl)amino]-1,3,5-triazin-2- subject to this section. The provisions of yl]amino]-2-[2-[4-[[4-[bis(2- § 721.1725(b)(1) apply to this section. hydroxypropyl)amino]-6-[(3- sulfophenyl)amino]-1,3,5-triazin-2- [57 FR 44075, Sept. 23, 1992, as amended at 58 yl]amino]-2-sulfophenyl]ethenyl]-, FR 29946, May 24, 1993; 58 FR 34204, June 23, disodium salt, compd. with 2,2′,2″- 1993] nitrilotris[ethanol] (1:2). § 721.9750 2-Chloro-4,6- (a) Chemical substance and significant bis(substituted)-1,3,5-triazine, new uses subject to reporting. (1) The dihydrochloride. chemical substance identified as a ′ (a) Chemical substance and significant Benzenesulfonic acid, 2,2 -(1,2- new uses subject to reporting. (1) The ethenediyl)bis[5-[[4- chemical substance identified generi- [bis(2hydroxypropyl)amino]-6-[(3- cally as 2-chloro-4,6-bis(substituted)- sulfophenyl)amino]-1,3,5-triazin-2- 1,3,5-triazine, dihydrochloride (PMN P- yl]amino]-, disodium salt, compd. with ′ ″ 91–659) is subject to reporting under 2,2 ,2 -nitrilotris[ethanol] (1:2); this section for the significant new Benzenesulfonic acid, 5-[[4-[bis(2-hy- uses described in paragraph (a)(2) of droxyethyl)amino]-6-[(3- this section. sulfophenyl)amino]-1,3,5-triazin-2- (2) The significant new uses are: yl]amino]-2-[2-[4-[[4-[bis(2- (i) Hazard communication program. Re- hydroxypropyl)amino]-6-[(3- quirements as specified in § 721.72 (a), sulfophenyl)amino]-1,3,5-triazin-2- (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), yl]amino]-2-sulfophenyl] ethenyl]-, di- ′ ″ (g)(4)(i), and (g)(5). The following addi- sodium salt, compd. with 2,2 ,2 - tional statements shall appear on each nitrilotris[ethanol] (1:2) (PMN P-98–716; label and MSDS required by this para- CAS Nos. 198716–46–0 and 198716–48–2) is graph: This substance may be toxic to subject to reporting under this section terrestrial organisms and plants. No- for the significant new use described in tice to users: Release to water restric- paragraph (a)(2) of this section. tions apply. (2) The significant new uses are: (ii) Disposal. Requirements as speci- (i) Industrial, commercial, and con- fied in § 721.85. A significant new use of sumer activities. Requirements as speci- this substance is any release of this fied in § 721.80 (v)(1), (v)(2), (w)(1), substance to land. (w)(2), (x)(1), and (x)(2). (iii) Release to water. Requirements as (ii) [Reserved] specified in § 721.90 (a)(4), (b)(4), and (b) Specific requirements. The provi- (c)(4) (where N = 10 ppb). sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph.

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(1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a), (i) Industrial, commercial, and con- (b), (c), and (i) are applicable to manu- sumer activities. Requirements as speci- facturers, importers, and processors of fied in § 721.80 (v)(1), (v)(2), (w)(1), this substance. (w)(2), (x)(1), and (x)(2). (2) Limitations or revocation of certain (ii) [Reserved] notfication requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to [65 FR 373, Jan. 5, 2000] this section except as modified by this paragraph. § 721.9795 Benzenesulfonic acid, 2,2′- (1,2-ethenediyl)bis[(4,6-dichloro- (1) Recordkeeping. Recordkeeping re- 1,3,5-triazin-2-yl) amino]-, disodium quirements as specified in § 721.125 (a), salt, substituted with dialkyl (b), (c), and (i) are applicable to manu- amines (generic). facturers, importers, and processors of (a) Chemical substance and significant this substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified generi- notification requirements. The provisions cally as a benzenesulfonic acid, 2,2′-(1,2- of § 721.185 apply to this section. ethenediyl)bis[(4,6-dichloro-1,3,5- triazin-2-yl)amino]-, disodium salt, [65 FR 374, Jan. 5, 2000] substituted with dialkyl amines (PMN § 721.9800 Poly(substituted triazinyl) P-98–774) is subject to reporting under piperazine (generic name). this section for the significant new use described in paragraph (a)(2) of this (a) Chemical substance and significant section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance poly(substituted (i) Industrial, commercial, and con- triazinyl) piperazine (PMN P-88–436) is sumer activities. Requirements as speci- subject to reporting under this section fied in § 721.80 (v)(1), (w)(1), (x)(1). for the significant new uses described (ii) [Reserved] in paragraph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Hazard communication program. Re- this section except as modified by this quirements as specified in § 721.72 (b)(2), paragraph. (c), (e) (concentration set at 1.0 per- (1) Recordkeeping. Recordkeeping recent), (f), (g)(1) (statement-health ef- quirements as specified in § 721.125 (a), fects not fully determined), (g)(2)(i), (b), (c), and (i) are applicable to manu- (g)(2)(ii), (g)(2)(iii), and (g)(5). The re- facturers, importers, and processors of this substance. quirements of this paragraph shall not (2) Limitations or revocation of certain apply when the PMN substance is en- notification requirements. The provisions capsulated in a polymeric matrix. of § 721.185 apply to this section. (ii) Industrial, commercial, and consumer activities. Requirements as speci- [65 FR 373, Jan. 5, 2000] fied in § 721.80(q). § 721.9798 Benzenesulfonic acid, 2,2′- (b) Specific requirements. The provi- (1,2-ethenediyl)bis[5-[[4-substituted- sions of subpart A of this part apply to 6-substituted-1,3,5-triazin-2- this section except as modified by this yl]amino]-, sodium salt (generic). paragraph. (a) Chemical substance and significant (1) Recordkeeping. The following rec- new uses subject to reporting. (1) The ordkeeping requirements are applicable chemical substance identified generi- to manufacturers, importers, and proc- cally as a benzenesulfonic acid, 2,2′-(1,2- essors of this substance, as specified in ethenediyl)bis[5-[[4-substituted-6-sub- § 721.125 (a) through (c), (g), and (h). stituted-1,3,5-triazin-2-yl]amino]-, so- (2) Limitations or revocation of certain dium salt (PMN P-98–1222) is subject to notification requirements. The provisions reporting under this section for the sig- of § 721.185 apply to this significant new nificant new use described in paragraph use rule. (a)(2) of this section.

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(3) Determining whether a specific use is § 721.9825 Phenyl substituted subject to this section. The provisions of triazolinones. § 721.1725(b)(1) apply to this section. (a) Chemical substance and significant [55 FR 32419, Aug. 9, 1990. Redesignated and new uses subject to reporting. (1) The amended at 58 FR 29946, 29947, May 24, 1993; 58 chemical substances identified generi- FR 34204, June 23, 1993; 63 FR 45956, Aug. 28, cally as phenyl substituted 1998] triazolinones (PMNs P-93–204, P-94–1870, P-94–1871, P-94–1872, P-94–1873, and P-94– § 721.9820 Substituted triazole. 1874) are subject to reporting under (a) Chemical substance and significant this section for the significant new new uses subject to reporting. (1) The uses described in paragraph (a)(2) of chemical substance generically identi- this section. fied as a substituted triazole (PMN P- (2) The significant new uses are: 90–1731) is subject to reporting under (i) Protection in the workplace. Re- this section for the significant new quirements as specified in § 721.63 (a)(1), uses described in paragraph (a)(2) of (a)(2)(i), (a)(3), (a)(4), (a)(5)(iii), this section. (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(6)(i), (2) The significant new uses are: (b) (concentration set at 1.0 percent), (i) Protection in the workplace. Re- and (c). The imperviousness of the quirements as specified in § 721.63 (a)(1), gloves selected pursuant to (a)(2)(i) of (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), this section must be demonstrated by (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), actual testing under (a)(3)(i) of this (a)(6)(i), (b) (concentration set at 0.1 section and not by manufacturer speci- percent), and (c). fications. In addition, there must be no permeation of the chemical substance (ii) Hazard communication program. greater than 15 μg/day-cm2 as a daily Requirements as specified in § 721.72 (a), cumulative total when tested in ac- (b), (c), (d), (e) (concentration set at 0.1 cordance with the most current version percent), (f), (g)(1)(i), (g)(1)(iv), of the American Society for Testing (g)(1)(v), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), and Materials (ASTM) F739 ‘‘Standard (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), Test Method for Resistance of Protec- (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), tive Clothing Materials to Permeation (g)(4)(ii), and (g)(5). by Liquids or Gases’’ or ASTM F1383 (iii) Industrial, commercial, and con- ‘‘Standard Test Method for Resistance sumer activities. Requirements as speci- of Protective Clothing Materials to fied in § 721.80(q). Permeation by Liquids or Gases Under (iv) Release to water. Requirements as Conditions of Intermittent Contact.’’ specified in § 721.90 (a)(4), (b)(4), and (A) For conditions of exposure which (c)(4) (where N = 12). are intermittent, gloves may be tested (b) Specific requirements. The provi- in accordance with the most current sions of subpart A of this part apply to version of ASTM F1383 ‘‘Standard Test this section except as modified by this Method for Resistance of Protective paragraph. Clothing Materials to Permeation by (1) Recordkeeping requirements. Re- Liquids or Gases Under Conditions of quirements as specified in § 721.125 (a) Intermittent Contact,’’ provided the through (k) are applicable to manufac- contact time in testing is greater than turers, importers, and processors of or equal to the expected duration of this substance. dermal contact, and the purge time (2) Limitations or revocation of certain used in the testing is less than or equal notification requirements. The provisions to the expected duration of non-contact during the intermittent cycle of of § 721.185 apply to this section. dermal exposure in the workplace. If (3) Determining whether a specific use is ASTM F1383 is used for testing, the subject to this section. The provisions of company must submit to the Agency a § 721.1725(b)(1) apply to this section. description of worker activities involv- [57 FR 44075, Sept. 23, 1992, as amended at 58 ing the chemical substance which in- FR 29946, May 24, 1993; 58 FR 34204, June 23, cludes daily frequencies and durations 1993] of potential worker exposures.

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(B) The results of all glove perme- this section except as modified by this ation testing must be reported in ac- paragraph. cordance with the most current version (1) Recordkeeping. Recordkeeping re- of (ASTM) F1194 ‘‘Guide for Docu- quirements as specified in § 721.125 (a), menting the Results of Chemical Per- (b), (c), (d), (e), (f), (g), (h), and (k) are meation Testing of Protective Clothing applicable to manufacturers, import- Materials.’’ The company must submit ers, and processors of these substances. all test data to the Agency and must (2) Limitations or revocation of certain receive written Agency approval for notification requirements. The provisions each type of glove tested prior to use of of § 721.185 apply to this section. such gloves. Gloves must be discarded [63 FR 3439, Jan. 22, 1998] and replaced with such frequency as to ensure that they will reliably provide § 721.9830 1-Tridecyn-3-ol, 3-methyl. an impervious barrier to the chemical substances under normal and expected (a) Chemical substance and significant conditions of exposure within the work new uses subject to reporting. (1) The area. Gloves that have been damaged chemical substance identified as 1- or are defective shall not be used. For tridecyn-3-ol, 3-methyl (PMN P-96–236; PMNs P-94–1871 through P-94–1874, EPA CAS No. 100912–15–0) is subject to re- has approved North Safety Butyl Rub- porting under this section for the sig- ber gloves (32 mils thick). For P-93–204 nificant new uses described in para- and P-94–1870, EPA has approved North graph (a)(2) of this section. Safety Butyl Rubber gloves (32 mils (2) The significant new uses are: thick) only if used in combination with (i) Worker protection. Requirements as a chemical-resistant glove that has specified in § 721.63 (a)(1), (a)(2)(i), and been demonstrated (EPA review not re- (a)(3). quired) impermeable to the solvent, (ii) Industrial, commercial, and con- e.g., North Silvershield gloves and sumer activities. Requirements as speci- North 4H gloves. fied in § 721.80(f). (b) The provi- (ii) Hazard communication program. Specific requirements. Requirements as specified in § 721.72 (a), sions of subpart A of this part apply to (b), (c), (d), (e) (concentration set at 1.0 this section except as modified by this percent), (f), (g)(1)(iv), (g)(1)(ix), paragraph. (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (1) Recordkeeping. Recordkeeping re- (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and quirements as specified in § 721.125 (a), (g)(5). (b), (c), (d), (e), and (i) are applicable to manufacturers, importers, and proc- (iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and essors of this substance. (c)(4) (N = 5 for all the chemical sub- (2) Limitations or revocation of certain stances subject to the provisions of notification requirements. The provisions this rule combined). However, contrary of § 721.185 apply to this section. to the requirements specified in § 721.91, [63 FR 3440, Jan. 22, 1998] if the waste stream containing the chemical substances will be treated § 721.9840 Tungstate (W12(OH)2O386-) using activated carbon adsorption, hexasodium (9CI). then the amount of chemical sub- (a) Chemical substance and significant stances reasonably likely to be renew uses subject to reporting. (1) The moved from the waste stream by such chemical substance identified as treatment may be subtracted in calcu- tungstate (W12(OH)2O386-) hexasodium lating the number of kilograms re- (9CI) (PMN P-96–1177; CAS No. 12141–67– leased. No more than the following per- 2) is subject to reporting under this cent removal efficiencies may be at- section for the significant new uses de- tributed to such treatment for each scribed in paragraph (a)(2) of this sec- PMN: P-93–204, 99 percent; P-94–1870, 98 tion. percent; P-94–1871, 97 percent; P-94–1872, (2) The significant new uses are: 92 percent; P-94–1873, 90 percent; P-94– (i) Industrial, commercial, and con- 1874, 73 percent. sumer activities. Requirements as speci- (b) Specific requirements. The provi- fied in § 721.80(j). sions of subpart A of this part apply to (ii) [Reserved]

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(b) Specific requirements. The provi- (3) Determining whether a specific use is sions of subpart A of this part apply to subject to this section. The provisions of this section except as modified by this § 721.1725(b)(1) apply to this section. paragraph. [57 FR 44075, Sept. 23, 1992, as amended at 58 (1) Recordkeeping. Recordkeeping re- FR 29946, May 24, 1993; 58 FR 34204, June 23, quirements as specified in § 721.125 (a), 1993] (b), (c), (d), (e), and (i) are applicable to manufacturers, importers, and proc- § 721.9892 Alkylated urea. essors of this substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance identified generi- of § 721.185 apply to this section. cally as an alkylated urea (PMN P-93– 1649) is subject to reporting under this [63 FR 3440, Jan. 22, 1998] section for the significant new uses described in paragraph (a)(2) of this sec- § 721.9850 2,4,8,10-Tetraoxa-3,9- tion. diphosphaspiro[5.5]undecane, 3,9- (2) The significant new uses are: bis[2,4,6-tris(1,1- (i) Protection in the workplace. Re- dimethylethyl)phenoxy]-. quirements as specified in § 721.63 (a)(1), (a) Chemical substance and significant (a)(3), (b) (concentration set at 1.0 per- new uses subject to reporting. (1) The cent), and (c). chemical substance identified as (ii) Hazard communication program. 2,4,8,10-tetraoxa-3,9- Requirements as specified in § 721.72 (a), diphosphaspiro[5.5]undecane, 3,9- (b), (c), (d), (e) (concentration set at 1.0 bis[2,4,6-tris(1,1-dimethyl- percent), (f), (g)(1)(iii), (g)(1)(ix), (g)(2)(i), (g)(2)(iii), (g)(2)(v), and (g)(5). ethyl)phenoxy]- (PMN P-91–65; CAS (iii) Industrial, commercial, and con- number 126505–35–9) is subject to re- sumer activities. Requirements as speci- porting under this section for the sig- fied in § 721.80 (l) and (q). nificant new uses described in para- (b) Specific requirements. The provi- graph (a)(2) of this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Protection in the workplace. Re- paragraph. quirements as specified in § 721.63 (a)(1), (1) Recordkeeping. Recordkeeping re- (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), quirements as specified in § 721.125 (a) (a)(5)(v), (a)(6)(i), (b) (concentration set through (i) are applicable to manufac- at 1.0 percent), and (c). turers, importers, and processors of (ii) Hazard communication program. this substance. Requirements as specified in § 721.72 (a), (2) Limitations or revocation of certain (b), (c), (d), (e) (concentration set at 1.0 notification requirements. The provisions percent), (f), (g)(1)(iii), (g)(1)(vi), of § 721.185 apply to this section. (g)(1)(ix), (g)(2)(i) through (v), and (3) Determining whether a specific use is (g)(5). subject to this section. The provisions of § 721.575(b)(1) apply to this section. (iii) Industrial, commercial, and consumer activities. Requirements as speci- [60 FR 45085, Aug. 30, 1995] fied in § 721.80(q). § 721.9900 Urea, condensate with (b) Specific requirements. The provi- poly[oxy(methyl-1,2-ethanediyl)]-α- sions of subpart A of this part apply to (2-aminomethylethyl)-μ-(2-amino- this section except as modified by this ethylethoxy) (generic name). paragraph. (a) Chemical substances and significant (1) Recordkeeping requirements. Re- new uses subject to reporting. (1) The quirements as specified in § 721.125 (a) chemical substance urea, condensate through (h) are applicable to manufac- with poly[oxy(methyl-1,2-ethanediyl)]- turers, importers, and processors of a-(2-aminomethylethyl)-μ-(2- this substance. aminoethylethoxy) (PMN P-84–482) is (2) Limitations or revocation of certain subject to reporting under this section notification requirements. The provisions for the significant new uses described of § 721.185 apply to this section. in paragraph (a)(2) of this section.

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(2) The significant new uses are: § 721.9925 Aminoethylethylene urea (i) Industrial, commercial, and con- methacrylamide. sumer activities. Requirements as speci- (a) Chemical substance and significant fied in § 721.80(q). new uses subject to reporting. (1) The (ii) [Reserved] chemical substance identified generi- (b) Specific requirements. The provi- cally as an aminoethylethylene urea sions of subpart A of this part apply to methacrylamide (PMN P-89–1038) is this section except as modified by this subject to reporting under this section paragraph. for the significant new uses described (1) Recordkeeping. The following rec- in paragraph (a)(2) of this section. ordkeeping requirements are applicable (2) The significant new uses are: (i) to manufacturers, importers, and proc- Industrial, commercial and consumer ac- essors of this substance: Recordkeeping tivities. Requirements as specified in requirements specified in § 721.125 (a), § 721.80(f). (b), (c), and (i). (ii) [Reserved] (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this (3) Determining whether a specific use is paragraph. subject to this section. The provisions of (1) Recordkeeping. Recordkeeping re- § 721.1725(b)(1) apply to this section. quirements as specified in § 721.125 (a) and (i) are applicable to manufactur- [55 FR 26102, June 26, 1990. Redesignated and ers, importers, and processors of this amended at 58 FR 29947, May 24, 1993; 58 FR substance. 34204, June 23, 1993] (2) Limitations or revocation of certain notification requirements. The provisions § 721.9920 Urea, (hexahydro-6-methyl- 2-oxopyrimidinyl)-. of § 721.185 apply to this section. (a) Chemical substance and significant [58 FR 51709, Oct. 4, 1993] new uses subject to reporting. (1) The § 721.9928 Urea, tetraethyl-. chemical substance urea, (hexahydro-6- methyl-2oxopyrimidinyl)- (PMN P-89– (a) Chemical substance and significant 303) is subject to reporting under this new uses subject to reporting. (1) The section for the significant new uses de- chemical substance identified as urea, scribed in paragraph (a)(2) of this sec- tetraethyl- (PMN P-94–1017; CAS No. tion. 1187–03–7) is subject to reporting under (2) The significant new uses are: this section for the significant new (i) Industrial, commercial, and con- uses described in paragraph (a)(2) of sumer activities. Requirements as speci- this section. fied in § 721.80(p) (level set at 1,975,000 (2) The significant new uses are: and 2,200,000 kg). (i) Protection in the workplace. Re- (ii) [Reserved] quirements as specified in § 721.63 (a)(1), (a)(2)(i), and (a)(3). (b) Specific requirements. The provi- (ii) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Requirements as speci- this section except as modified by this fied in § 721.80(r) (445,000 kg) (a dermal paragraph. developmental toxicity study in mice (1) Recordkeeping. The following rec- and rats and either a chromosome ab- ordkeeping requirements are applicable erration assay in mice (40 CFR 798.5385) to manufacturers, importers, and proc- or a micronucleus assay in mice (40 essors of this substance, as specified in CFR 798.5395)). A person may not manu- § 721.125 (a), (b), (c), and (i). facture or import the substance beyond (2) Limitations or revocation of certain the following aggregate production vol- notification requirements. The provisions ume limits, unless that person con- of § 721.185 apply to this significant new ducts the following corresponding stud- use rule. ies on the substance and submits all [55 FR 26102, June 26, 1990. Redesignated at 58 final reports and underlying data in ac- FR 29947, May 24, 1993, as amended at 58 FR cordance with the procedures and cri- 34204, June 23, 1993] teria specified in paragraphs

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(a)(2)(i)(A), (a)(2)(i)(B), (a)(2)(i)(C), and (2) The person may continue to man- (a)(2)(i)(D) of this section. ufacture and import the PMN sub- (A) Each study required to be per- stance beyond the applicable produc- formed pursuant to this section must tion limit only if so notified, in writ- be scientifically valid. Scientific valid ing, by EPA in response to the person’s means that the study was conducted compliance with either of the following according to: paragraph (a)(2)(ii)(D)(2)(i) or (1) The test guidelines specified in (a)(2)(ii)(D)(2)(ii) of this section. paragraph (a)(2)(i) of this section. (i) The person may reconduct the (2) An EPA-approved protocol. study. If there is sufficient time to re- (3) TSCA Good Laboratory Practice conduct the study and submit the re- Standards at 40 CFR part 792. port and data to EPA at least 14 weeks (4) Using methodologies generally ac- before exceeding the production limit cepted at the time the study is initi- as required by paragraph (a)(2)(ii)(C)(3) ated. of this section, the person shall comply (5) Any deviation from these require- with paragraph (a)(2)(ii)(C)(3) of this ments must be approved in writing by section. If there is insufficient time for EPA. the person to comply with paragraph (B) Before starting to conduct any of (a)(2)(ii)(C)(3) of this section, the per- the studies in paragraph (a)(2)(i) of this son may exceed the production limit section, the person must obtain ap- and shall submit the report and data in proval of test protocols from EPA by triplicate to EPA within a reasonable submitting written protocols. EPA will period of time, all as specified by EPA respond to the person within 4 weeks of in the notice described in paragraph receiving the written protocols. Pub- (a)(2)(ii)(D)(1) of this section. EPA will lished test guidelines specified in para- respond to the person in writing, with- graph (a)(2)(i) of this section (e.g., 40 in 6 weeks of receiving the person’s re- CFR part 797 or part 798) provide gen- port and data. eral guidance for development of test (ii) The person may, within 4 weeks protocols, but are not themselves ac- of receiving from EPA the notice de- ceptable protocols. scribed in paragraph (a)(2)(ii)(D)(1) of (C) The person shall: this section, submit to EPA a written (1) Conduct each study in good faith report refuting EPA’s finding. EPA will with due care. respond to the person in writing, with- (2) Promptly furnish to EPA the rein 4 weeks of receiving the person’s results of any interim phase of each port. study. (E) The person is not required to con- (3) Submit, in triplicate (with an adduct a study specified in paragraph ditional sanitized copy, if confidential (a)(2)(i) of this section if notified in business information is involved), the writing by EPA that it is unnecessary final report of each study and all un- to conduct that study. derlying data (‘‘the report and data’’) (iii) Release to water. Requirements as to EPA no later than 14 weeks prior to specified in § 721.90 (a)(1), (b)(1), and exceeding the applicable production (c)(1). volume limit. The final report shall (b) Specific requirements. The provi- contain the contents specified in 40 sions of subpart A of this part apply to CFR 792.185. this section except as modified by this (D)(1) Except as described in para- paragraph. graph (a)(2)(ii)(D)(2) of this section, if, (1) Recordkeeping. Recordkeeping re- within 6 weeks of EPA’s receipt of a quirements as specified in § 721.125 (a), test report and data, the person re- (b), (c), (d), (e), (i), and (k) are applica- ceives written notice that EPA finds ble to manufacturers, importers, and that the data generated by a study are processors of this substance. scientifically invalid, the person is pro- (2) Limitations or revocation of certain hibited from further manufacture and notification requirements. The provisions import of the PMN substance beyond of § 721.185 apply to this section. the applicable production volume limit. [63 FR 3440, Jan. 22, 1998]

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§ 721.9929 Polyurea (generic). § 721.9952 Alkoxylated aliphatic diisocyanate allyl ether (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as a polyurea (PMN P-01–716) is chemical substance identified generi- subject to reporting under this section cally as alkoxylated aliphatic for the significant new use described in diisocyanate allyl ether (PMN P-00– 0353) is subject to reporting under this paragraph (a)(2) of this section. section for the significant new use de- (2) The significant new uses are: scribed in paragraph (a)(2) of this sec- (i) Release to water. Requirements as tion. specified § 721.90(a)(1), (b)(1), and (c)(1). (2) The significant new uses are: (ii) [Reserved] (i) Release to water. Requirements as (b) Specific requirements. The provi- specified § 721.90 (a)(1), (b)(1), and (c)(1). sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125(a), paragraph. (b), (c), and (k) are applicable to manu- (1) Recordkeeping. Recordkeeping re- facturers, importers, and processors of quirements as specified in § 721.125 (a), this chemical substance. (b), (c), and (k) are applicable to manufacturers, importers, and processors of (2) Limitations or revocation of certain this substance. notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions [68 FR 70184, Dec. 17, 2003] of § 721.185 apply to this section. [68 FR 15089, Mar. 28, 2003] § 721.9930 Urethane. (a) Chemical substance and significant § 721.9957 N-Nitroso-N- new uses subject to reporting. (1) The methylurethane. chemical substance urethane, CAS (a) Chemical substance and significant Number 51–79–6, is subject to reporting new use subject to reporting. (1) The under this section for the significant chemical substance N-nitroso-N- new uses described in paragraph (a)(2) methylurethane (CAS No. 615–53–2) is of this section. subject to reporting under this section (2) The significant new use is: Any for the significant new use described in use. paragraph (a)(2) of this section. (2) The significant new use is: Manu- (b) Special provisions. The provisions facture, import, or processing of 10,000 of subpart A of this part apply to this pounds or more per year per facility for section except as modified by this any use. paragraph. (b) Specific requirements. The provi- (1) Persons who must report. Section sions of subpart A of this part apply to 721.5 applies to this section except for this section except as modified by this § 721.5(a)(2). A person who intends to paragraph. manufacture, import, or process for (1) Recordkeeping. The following rec- commercial purposes the substance ordkeeping requirements are applicable identified in paragraph (a)(1) of this to manufacturers, importers, and proc- section and intends to distribute the essors of this substance, as specified in substance in commerce must submit a § 721.125 (a), (b), and (c). significant new use notice. (2) [Reserved] (2) [Reserved] [58 FR 63518, Dec. 1, 1993] [51 FR 9453, Mar. 19, 1986. Redesignated at 53 FR 2845, Feb. 2, 1988. Further redesignated at § 721.9959 Polyurethane polymer (generic). 58 FR 29947, May 24, 1993, as amended at 58 FR 34204, June 23, 1993] (a) Chemical substance and significant new uses subject to reporting. (1) The

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chemical substance identified generi- (g)(1)(v), (g)(1)(vi), (g)(2)(i), (g)(2)(ii), cally as a polyurethane polymer (PMN (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), P-01–481) is subject to reporting under (g)(3)(ii), and (g)(5). this section for the significant new use (iii) Industrial, commercial, and con- described in paragraph (a)(2) of this sumer activities. Requirements as speci- section. fied in § 721.80(q). (2) The significant new uses are: (iv) Release to water. Requirements as (i) Industrial, commercial, and con- specified in § 721.90 (a)(4) and (b)(4) sumer activities. Requirements as speci- (N=6). fied in § 721.80(j). (b) Specific requirements. The provi- (ii) [Reserved] sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), (d), (e), (f), (g), (h), (i), and (k) quirements as specified in § 721.125(a), are applicable to manufacturers, im- (b), (c), and (i) are applicable to manufacturers, importers, and processors of porters, and processors of this sub- this chemical substance. stance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. (3) Determining whether a specific use is (3) Determining whether a specific use is subject to this section. The provisions of subject to this section. The provisions of § 721.1725(b)(1) apply to this section. § 721.1725(b)(1) apply to this section. [68 FR 70184, Dec. 17, 2003] [65 FR 374, Jan. 5, 2000]

§ 721.9965 Fatty acids, C10-13 - § 721.9969 3,6-Bis(dialkylamino) -9-[2- branched, vinyl esters. alkoxycarbonyl) phenyl]- (a) Chemical substance and significant xanthylium salt (generic). new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified as fatty new uses subject to reporting. (1) The acids, C10-13 - branched, vinyl esters chemical substance identified generi- (PMN P-97–482; CAS No. 184785–38–4) is cally as 3,6-bis(dialkylamino) -9-[2- subject to reporting under this section alkoxycarbonyl) phenyl]-xanthylium for the significant new uses described salt (PMN P-97–854) is subject to rein paragraph (a)(2) of this section. porting under this section for the sig- (2) The significant new uses are: nificant new uses described in para- (i) Protection in the workplace. Re- graph (a)(2) of this section. quirements as specified in § 721.63 (a)(1), (2) The significant new uses are: (a)(2), (a)(3), (a)(4), (a)(5)(ii) (if data on (i) Industrial, commercial, and con- Cartridge Service Life Testing has been sumer activities. Requirements as speci- reviewed and approved in writing by fied in § 721.80 (f) and (j). EPA). The following respirators may be (ii) [Reserved] used as specified in § 721.63 (a)(5)(xii), (b) Specific requirements. The provi- (a)(5)(xiii), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), sions of subpart A of this part apply to (a)(6)(v), (b) (concentration set at 1.0 this section except as modified by this percent), and (c). As an alternative to paragraph. the respiratory requirements listed (1) Recordkeeping. Recordkeeping re- here, a manufacturer, importer, or quirements as specified in § 721.125 (a), processor may choose to follow the (b), (c), and (i) are applicable to manu- NCEL provisions listed in the TSCA facturers, importers, and processors of section 5(e) consent order for this sub- this substance. stance. The NCEL is 1 ppm. (2) Limitations or revocation of certain (ii) Hazard communication program. notification requirements. The provisions Requirements as specified in § 721.72 (a), of § 721.185 apply to this section. (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(i), (g)(1)(iii), [63 FR 44583, Aug. 20, 1998]

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§ 721.9970 o-Xylene compound (generic § 721.10000 Certain polybrominated name). diphenylethers. (a) Chemical substance and significant (a) Chemical substances and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substances identified as cally as an o-xylene compound (PMN P- tetrabromodiphenyl ether (CAS No. 95–1030) is subject to reporting under 40088–47–9; Benzene, 1,1′-oxybis-, tetra- this section for the significant new bromo deriv.), pentabromodiphenyl uses described in paragraph (a)(2) of ether (CAS No. 32534–81–9; Benzene, 1,1′- this section. oxybis-, pentabromo deriv.), (2) The significant new uses are: hexabromodiphenyl ether (CAS No. (i) Industrial, commercial, and con- 36483–60–0; Benzene, 1,1′-oxybis-, sumer activities. Requirements as speci- hexabromo deriv.), fied in § 721.80(j). heptabromodiphenyl ether (CAS No. (ii) [Reserved] 68928–80–3; Benzene, 1,1′-oxybis-, (b) Specific requirements. The provi- heptabromo deriv.), octabromodiphenyl sions of subpart A of this part apply to ether (CAS No. 32536–52–0; Benzene, 1,1′- this section except as modified by this oxybis-, octabromo deriv.), and paragraph. nonabromodiphenyl ether (CAS No. (1) Recordkeeping. Recordkeeping re- 63936–56–1; Benzene, quirements as specified in § 721.125 (a), pentabromo(tetrabromophenoxy)-), or (b), (c), and (i) are applicable to manu- any combination of these substances facturers, importers, and processors of resulting from a chemical reaction are this substance. subject to reporting under this section (2) Limitations or revocation of certain for the significant new uses described notification requirements. The provisions in paragraph (a)(2) of this section. of § 721.185 apply to this section. (2) The significant new use is manufacture or import for any use on or [61 FR 63740, Dec. 2, 1996] after January 1, 2005. (b) Specific requirements. The provi- § 721.9973 Zirconium dichlorides (generic). sions of subpart A of this part apply to this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Persons who must report. Section chemical substances identified generi- 721.5 applies to this section except for cally as zirconium dichlorides (PMNs § 721.5(a)(2). A person who intends to P-97–179/181/189/769/775/781/782/783) are manufacture or import for commercial subject to reporting under this section purposes a substance identified in para- for the significant new uses described graph (a)(1) of this section and intends in paragraph (a)(2) of this section. to distribute the substance in com- (2) The significant new uses are: merce must submit a significant new (i) Release to water. Requirements as use notice. specified in § 721.90 (a)(4), (b)(4), and (2) [Reserved] (c)(4) (N = 20). (ii) [Reserved] [71 FR 34021, June 13, 2006] (b) Specific requirements. The provisions of subpart A of this part apply to § 721.10001 2-Ethoxyethanol, 2- ethoxyethanol acetate, 2- this section except as modified by this methoxyethanol, and 2- paragraph. methoxyethanol acetate. (1) Recordkeeping. Recordkeeping re- (a) Chemical substances and significant quirements as specified in § 721.125 (a), new uses subject to reporting. (1) The (b), (c), and (k) are applicable to manu- chemical substances identified as 2- facturers, importers, and processors of ethoxyethanol (CAS No. 110–80–5), 2- these substances. ethoxyethanol acetate (CAS No. 111–15– (2) Limitations or revocation of certain 9), 2-methoxyethanol (CAS No. 109–86– notification requirements. The provisions 4), and 2-methoxyethanol acetate (CAS of § 721.185 apply to this section. No. 110–49–6) are subject to reporting [63 FR 44583, Aug. 20, 1998] under this section for the significant

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new use described in paragraph (a)(2) of or processor may choose to follow the this section. new chemical exposure limit (NCEL) (2) The significant new use is domes- provisions listed in the TSCA section tic use in a consumer product or the 5(e) consent order for this substance. manufacture or import of 2- The NCEL is 0.7 mg/m3 as an 8-hour methoxyethanol acetate at levels time-weighted average. Persons who greater than 10,000 pounds per year. wish to pursue NCELs as an alternative (b) Specific requirements. The provi- to the § 721.63 respirator requirements sions of subpart A of this part apply to may request to do so under 40 CFR this section except as modified by this 721.30. Persons whose § 721.30 requests paragraph. to use the NCELs approach are ap- (1) Recordkeeping. Recordkeeping re- proved by EPA will receive NCELs pro- quirements as specified in § 721.125 (a), (b), and (c) apply to the significant new visions comparable to those contained use specified in § 721.10001. In addition, in the corresponding section 5(e) con- records documenting compliance with sent order. the significant new use of domestic use (ii) Hazard communication program. in a consumer product or the manufac- Requirements as specified in § 721.72 (a), ture or import of 2-methoxyethanol ac- (b), (c), (d), (e) (concentration set at 1.0 etate at levels greater than 10,000 percent), (f), (g)(1)(iii), (g)(1)(iv), pounds per year must be maintained. (g)(1)(vi), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (2) [Reserved] (g)(2)(iii), (g)(2)(iv) (use respiratory [70 FR 71406, Nov. 29, 2005] protection or maintain workplace airborne concentrations at or below an 8- § 721.10002 2-Thiazolidinone. hour time-weighted average of 0.7 mg/ 3 (a) Chemical substance and significant m ), (g)(2)(v), (g)(3)(ii), (g)(4)(i), new uses subject to reporting. (1) The (g)(4)(ii), (g)(4)(iii), and (g)(5). The fol- chemical substance identified as 2- lowing statement shall appear on each thiazolidinone (PMN P–97–415; CAS No. label as specified in § 721.72(b) and the 2682–49–7) is subject to reporting under Material Safety Data Sheet (MSDS) as this section for the significant new specified in § 721.72(c). The substance uses described in paragraph (a)(2) of may cause severe eye irritation. The this section. substance may cause internal organ ef- (2) The significant new uses are: fects (blood, liver, and kidney). The (i) Protection in the workplace. Re- substance may cause developmental/ quirements as specified in § 721.63 (a)(1), maternal effects. When handling this (a)(3), (a)(4), (a)(6)(i), (b), and (c). The substance as a powder, use respiratory following National Institute for Occu- protection. pational Safety and Health (NIOSH)- (iii) Industrial, commercial, and con- approved respirators with an assigned sumer activities. Requirements as speci- protection factor (APF) of 10–25 meet fied in § 721.80 (g), (p) (300,000 kilo- the minimum requirements for grams), (v)(1), (w)(1), and (x)(1). § 721.63(a)(4): Air-purifying, tight-fit- (iv) Disposal. Requirements as speci- ting respirator (either half- or full- fied in § 721.85 (a)(1), (a)(2), (a)(3), (b)(1), face) equipped with N100 (if aerosols (b)(2), (b)(3), (c)(1), (c)(2), and (c)(3). absent), R100, or P100 filters; powered air-purifying respirator equipped with (v) Release to water. Requirements as a loose-fitting hood or helmet and High specified in § 721.90 (a)(1), (b)(1), and Efficiency Particulate Air (HEPA) fil- (c)(1). ters; powered air-purifying respirator (b) Specific requirements. The provi- equipped with a tight-fitting facepiece sions of subpart A of this part apply to (either half- or full-face) and HEPA fil- this section except as modified by this ters; and supplied-air respirator oper- paragraph. ated in pressure demand or continuous (1) Recordkeeping. Recordkeeping re- flow mode and equipped with a hood or quirements as specified in § 721.125 (a), helmet or tight-fitting facepiece (ei- (b), (c), (d), (e), (f), (g), (h), (i), (j), and ther half- or full-face). As an alter- (k) are applicable to manufacturers, native to the respiratory requirements importers, and processors of this sub- listed here, a manufacturer, importer, stance.

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(2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this paragraph. [72 FR 14697, Mar. 29, 2007] (1) Recordkeeping. Recordkeeping re- § 721.10003 Manganese heterocyclic quirements as specified in § 721.125 (a), tetraamine complex (generic). (b), (c), (d), (e), and (i) are applicable to (a) Chemical substances and significant manufacturers, importers, and proc- new uses subject to reporting. (1) The essors of this substance. chemical substances identified generi- (2) Limitations or revocation of certain cally as manganese heterocyclic notification requirements. The provisions tetraamine complex (PMNs P–98–625/ of § 721.185 apply to this section. 626/627/628/629 and P–00–614/617) are sub- [72 FR 14698, Mar. 29, 2007] ject to reporting under this section for the significant new uses described in § 721.10005 2-Butenoic acid, 4,4′- paragraph (a)(2) of this section. [(dibutylstannylene)bis(oxy)]bis [4- (2) The significant new uses are: oxo-, (2Z,2′Z)-, di-C19-11-isoalkyl (i) Industrial, commercial, and con- esters, C10-rich. sumer activities. Requirements as speci- (a) Chemical substance and significant fied in § 721.80(s) (10,000 kilograms per new uses subject to reporting. (1) The chemical substance). chemical substance identified as 2- (ii) [Reserved] butenoic acid, 4 ,4′- (b) Specific requirements. The provi- [(dibutylstannylene)bis(oxy)]bis [4-oxo- sions of subpart A of this part apply to , (2Z,2′Z)-, di-C9-11-isoalkyl esters, C10- this section except as modified by this rich (PMN P–98–1182) is subject to re- paragraph. porting under this section for the sig- (1) Recordkeeping. Recordkeeping re- nificant new uses described in para- quirements as specified in § 721.125 (a), graph (a)(2) of this section. (b), (c), and (i) are applicable to manu- (2) The significant new uses are: facturers, importers, and processors of (i) Protection in the workplace. Re- this substance. quirements as specified in § 721.63 (a)(1), (2) Limitations or revocation of certain (a)(2)(i), and (a)(3). notification requirements. The provisions (ii) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as speci- [72 FR 14698, Mar. 29, 2007] fied in § 721.80 (v)(2), (w)(2), (x)(2), and (y)(1). § 721.10004 2-Butenoic acid, 4,4′- (b) Specific requirements. The provi- [(dibutylstannylene)bis(oxy)]bis[4- ′ sions of subpart A of this part apply to oxo-, (2Z,2 Z)-, di-C8-10-isoalkyl this section except as modified by this esters, C -rich. 9 paragraph. (a) Chemical substance and significant (1) Recordkeeping. Recordkeeping renew uses subject to reporting. (1) The quirements as specified in § 721.125 (a), chemical substance identified as 2- (b), (c), (d), (e), and (i) are applicable to butenoic acid, 4,4′- manufacturers, importers, and proc- [(dibutylstannylene)bis(oxy)]bis[4-oxo-, essors of this substance. ′ (2Z,2 Z)-, di-C8-10-isoalkyl esters, C9-rich (2) Limitations or revocation of certain (PMN P–98–1181; CAS No. 247041–56–1) is notification requirements. The provisions subject to reporting under this section of § 721.185 apply to this section. for the significant new uses described in paragraph (a)(2) of this section. [72 FR 14698, Mar. 29, 2007] (2) The significant new uses are: (i) Protection in the workplace. Re- § 721.10006 Mixed metal oxide (ge- quirements as specified in § 721.63 (a)(1), neric). (a)(2)(i), and (a)(3). (a) Chemical substance and significant (ii) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified generi- fied in § 721.80 (v)(2), (w)(2), (x)(2), and cally as mixed metal oxide (PMN P–99– (y)(1). 511) is subject to reporting under this

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section for the significant new uses de- P–00–1121; CAS No. 12163–45–0) is subject scribed in paragraph (a)(2) of this sec- to reporting under this section for the tion. significant new uses described in para- (2) The significant new uses are: graph (a)(2) of this section. (i) Industrial, commercial, and con- (2) The significant new uses are: sumer activities. Requirements as speci- (i) Hazard communication program. Re- fied in § 721.80(s) (60,000 kilograms). quirements as specified in § 721.72 (a), (ii) [Reserved] (b), (c), (d), (e) (concentration set at 0.1 (b) Specific requirements. The provi- percent), (f), (g)(1)(i), (g)(1)(ii), sions of subpart A of this part apply to (g)(1)(iii), (g)(1)(vii), (g)(1)(viii), this section except as modified by this (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), paragraph. (g)(3)(ii), (g)(4)(i), and (g)(5). (1) Recordkeeping. Recordkeeping re- (ii) Industrial, commercial, and con- quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- sumer activities. Requirements as speci- facturers, importers, and processors of fied in § 721.80 (k) (manufacture, proc- this substance. essing, or use of the PMN substance if (2) Limitations or revocation of certain the particle size is less than 10 mi- notification requirements. The provisions crons) and (q). of § 721.185 apply to this section. (iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and [72 FR 14698, Mar. 29, 2007] (c)(4) (N=1). (b) Specific requirements. The provi- § 721.10007 Alcohols, C12-14-secondary, ethoxylated propoxylated. sions of subpart A of this part apply to this section except as modified by this (a) Chemical substance and significant new uses subject to reporting. (1) The paragraph. chemical substance identified as alco- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), hols, C12-14- secondary, ethoxylated propoxylated (PMN P–00–11; CAS No. (b), (c), (f), (g), (h), (i), and (k) are ap- 103331–86–8) is subject to reporting plicable to manufacturers, importers, under this section for the significant and processors of this substance. new uses described in paragraph (a)(2) (2) Limitations or revocation of certain of this section. notification requirements. The provisions (2) The significant new uses are: of § 721.185 apply to this section. (i) Release to water. Requirements as (3) Determining whether a specific use is specified in § 721.90 (a)(4), (b)(4), and subject to this section. The provisions of (c)(4) (N = 50). § 721.1725(b)(1) apply to this section. (ii) [Reserved] (b) Specific requirements. The provi- [72 FR 14699, Mar. 29, 2007] sions of subpart A of this part apply to § 721.10009 Manganese yttrium oxide this section except as modified by this (MnYO ). paragraph. 3 (1) Recordkeeping. Recordkeeping re- (a) Chemical substance and significant quirements as specified in § 721.125 (a), new uses subject to reporting. (1) The (b), (c), and (k) are applicable to manu- chemical substance identified as man- facturers, importers, and processors of ganese yttrium oxide (MnYO3) (PMN P– this substance. 00–1122; CAS No. 12032–75–6) is subject (2) Limitations or revocation of certain to reporting under this section for the notification requirements. The provisions significant new uses described in para- of § 721.185 apply to this section. graph (a)(2) of this section. [72 FR 14698, Mar. 29, 2007] (2) The significant new uses are: (i) Hazard communication program. Re- § 721.10008 Manganese strontium quirements as specified in § 721.72 (a), oxide (MnSrO3). (b), (c), (d), (e) (concentration set at 0.1 (a) Chemical substance and significant percent), (f), (g)(1)(i), (g)(1)(ii), new uses subject to reporting. (1) The (g)(1)(iii), (g)(1)(vii), (g)(1)(viii), chemical substance identified as man- (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), ganese strontium oxide (MnSrO3) (PMN (g)(3)(ii), (g)(4)(i), and (g)(5). 491

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(ii) Industrial, commercial, and con- (b), (c), (f), (g), (h), (i), and (k) are ap- sumer activities. Requirements as speci- plicable to manufacturers, importers, fied in § 721.80 (k) (manufacture, proc- and processors of this substance. essing, or use of the PMN substance if (2) Limitations or revocation of certain the particle size is less than 10 mi- notification requirements. The provisions crons) and (q). of § 721.185 apply to this section. (iii) Release to water. Requirements as (3) Determining whether a specific use is specified in § 721.90 (a)(4), (b)(4), and subject to this section. The provisions of (c)(4) (N=1). (b) Specific requirements. The provi- § 721.1725(b)(1) apply to this section. sions of subpart A of this part apply to [72 FR 14699, Mar. 29, 2007] this section except as modified by this paragraph. § 721.10011 Barium calcium man- (1) Recordkeeping. Recordkeeping re- ganese strontium oxide. quirements as specified in § 721.125 (a), (a) Chemical substance and significant (b), (c), (f), (g), (h), (i), and (k) are ap- new uses subject to reporting. (1) The plicable to manufacturers, importers, chemical substance identified as bar- and processors of this substance. ium calcium manganese strontium (2) Limitations or revocation of certain notification requirements. The provisions oxide (PMN P–00–1124; CAS No. 359427– of § 721.185 apply to this section. 90–0) is subject to reporting under this (3) Determining whether a specific use is section for the significant new uses de- subject to this section. The provisions of scribed in paragraph (a)(2) of this sec- § 721.1725(b)(1) apply to this section. tion. (2) The significant new uses are: [72 FR 14699, Mar. 29, 2007] (i) Hazard communication program. Re- § 721.10010 Barium manganese oxide quirements as specified in § 721.72 (a), (BaMnO3). (b), (c), (d), (e) (concentration set at 0.1 (a) Chemical substance and significant percent), (f), (g)(1)(i), (g)(1)(ii), new uses subject to reporting. (1) The (g)(1)(iii), (g)(1)(vii), (g)(1)(viii), chemical substance identified as bar- (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), ium manganese oxide (BaMnO3) (PMN (g)(3)(ii), (g)(4)(i), and (g)(5). P–00–1123; CAS No. 12230–80–7) is subject (ii) Industrial, commercial, and con- to reporting under this section for the sumer activities. Requirements as speci- significant new uses described in para- fied in § 721.80 (k) (manufacture, proc- graph (a)(2) of this section. essing, or use of the PMN substance if (2) The significant new uses are: the particle size is less than 10 mi- (i) Hazard communication program. Re- crons) and (q). quirements as specified in § 721.72 (a), (iii) Release to water. Requirements as (b), (c), (d), (e) (concentration set at 0.1 specified in § 721.90 (a)(4), (b)(4), and percent), (f), (g)(1)(i), (g)(1)(ii), (c)(4) (N=1). (g)(1)(iii), (g)(1)(vii), (g)(1)(viii), (b) Specific requirements. The provi- (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), sions of subpart A of this part apply to (g)(3)(ii), (g)(4)(i), and (g)(5). (ii) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80 (k) (manufacture, proc- (1) Recordkeeping. Recordkeeping re- essing, or use of the PMN substance if quirements as specified in § 721.125 (a), the particle size is less than 10 mi- (b), (c), (f), (g), (h), (i), and (k) are ap- crons) and (q). plicable to manufacturers, importers, (iii) Release to water. Requirements as and processors of this substance. specified in § 721.90 (a)(4), (b)(4), and (2) Limitations or revocation of certain (c)(4) (N=1). notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to (3) Determining whether a specific use is this section except as modified by this subject to this section. The provisions of paragraph. § 721.1725(b)(1) apply to this section. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), [72 FR 14699, Mar. 29, 2007]

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1- § 721.10012 Manganate (MnO2 ), cal- (g)(1)(iii), (g)(1)(vii), (g)(1)(viii), cium (2:1). (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (a) Chemical substance and significant (g)(3)(ii), (g)(4)(i), and (g)(5). new uses subject to reporting. (1) The (ii) Industrial, commercial, and con- chemical substance identified as man- sumer activities. Requirements as speci- 1- ganate (MnO2 ), calcium (2:1) (PMN P– fied in § 721.80 (k) (manufacture, proc- 00–1125; CAS No. 12049–47–7) is subject essing, or use of the PMN substance if to reporting under this section for the the particle size is less than 10 mi- significant new uses described in para- crons) and (q). graph (a)(2) of this section. (iii) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(4), (b)(4), and (i) Hazard communication program. Re- (c)(4) (N=1). quirements as specified in § 721.72 (a), (b) Specific requirements. The provi- (b), (c), (d), (e) (concentration set at 0.1 sions of subpart A of this part apply to percent), (f), (g)(1)(i), (g)(1)(ii), this section except as modified by this (g)(1)(iii), (g)(1)(vii), (g)(1)(viii), paragraph. (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (1) Recordkeeping. Recordkeeping re- (g)(3)(ii), (g)(4)(i), and (g)(5). quirements as specified in § 721.125 (a), (ii) Industrial, commercial, and con- (b), (c), (f), (g), (h), (i), and (k) are ap- sumer activities. Requirements as speci- plicable to manufacturers, importers, fied in § 721.80 (k) (manufacture, proc- and processors of this substance. essing, or use of the PMN substance if (2) Limitations or revocation of certain the particle size is less than 10 mi- notification requirements. The provisions crons) and (q). of § 721.185 apply to this section. (iii) Release to water. Requirements as (3) Determining whether a specific use is specified in § 721.90 (a)(4), (b)(4), and subject to this section. The provisions of (c)(4) (N=1). § 721.1725(b)(1) apply to this section. (b) Specific requirements. The provisions of subpart A of this part apply to [72 FR 14700, Mar. 29, 2007] this section except as modified by this paragraph. § 721.10014 Halogenated naphthalic (1) Recordkeeping. Recordkeeping re- anhydride (generic). quirements as specified in § 721.125 (a), (a) Chemical substance and significant (b), (c), (f), (g), (h), (i), and (k) are ap- new uses subject to reporting. (1) The plicable to manufacturers, importers, chemical substance identified generi- and processors of this substance. cally as halogenated naphthalic anhy- (2) Limitations or revocation of certain dride (PMN P–01–109) is subject to re- notification requirements. The provisions porting under this section for the sig- of § 721.185 apply to this section. nificant new uses described in para- (3) Determining whether a specific use is graph (a)(2) of this section. subject to this section. The provisions of (2) The significant new uses are: § 721.1725(b)(1) apply to this section. (i) Release to water. Requirements as [72 FR 14700, Mar. 29, 2007] specified in § 721.90 (a)(1), (b)(1), and (c)(1). § 721.10013 Manganese yttrium oxide (ii) [Reserved] (Mn YO ). 2 5 (b) Specific requirements. The provi- (a) Chemical substance and significant sions of subpart A of this part apply to new uses subject to reporting. (1) The this section except as modified by this chemical substance identified as man- paragraph. ganese yttrium oxide (Mn2YO5) (PMN (1) Recordkeeping. Recordkeeping re- P–00–1126; CAS No. 12438–71–0) is subject quirements as specified in § 721.125 (a), to reporting under this section for the (b), (c), and (k) are applicable to manu- significant new uses described in para- facturers, importers, and processors of graph (a)(2) of this section. this substance. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Hazard communication program. Re- notification requirements. The provisions quirements as specified in § 721.72 (a), of § 721.185 apply to this section. (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(i), (g)(1)(ii), [72 FR 14700, Mar. 29, 2007]

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§ 721.10015 Halogenated benzimidazole § 721.10017 Amine terminated (generic). bisphenol A diglycidyl ether poly- (a) Chemical substance and significant mer (generic). new uses subject to reporting. (1) The (a) Chemical substances and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as halogenated benzimidazole chemical substances identified generi- (PMN P–01–110) is subject to reporting cally as amine terminated bisphenol A under this section for the significant diglycidyl ether polymer (PMNs P–01– new uses described in paragraph (a)(2) 257/258/259 and P–01–261) are subject to of this section. reporting under this section for the sig- (2) The significant new uses are: nificant new uses described in para- (i) Release to water. Requirements as graph (a)(2) of this section. specified in § 721.90 (a)(1), (b)(1), and (2) The significant new uses are: (c)(1). (i) Release to water. Requirements as (ii) [Reserved] specified in § 721.90 (a)(1), (b)(1), and (b) Specific requirements. The provi- (c)(1). sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125 (a), paragraph. (b), (c), and (k) are applicable to manu- (1) Recordkeeping. Recordkeeping re- facturers, importers, and processors of quirements as specified in § 721.125 (a), this substance. (b), (c), and (k) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [72 FR 14700, Mar. 29, 2007] of § 721.185 apply to this section. § 721.10016 [72 FR 14700, Mar. 29, 2007] Dibenzimidazothianaphthalene (generic). § 721.10018 Calcium hydroxide oxide silicate (Ca (OH) O (Si O ) ). (a) Chemical substance and significant 6 2 2 2 5 3 new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as dibenzimidazothianaphthalene chemical substance identified as cal- (PMN P–01–111) is subject to reporting cium hydroxide oxide silicate under this section for the significant (Ca6(OH)2O2(Si2O5)3) (PMN P–01–442; new uses described in paragraph (a)(2) CAS No. 13169–90–9) is subject to report- of this section. ing under this section for the signifi- (2) The significant new uses are: cant new uses described in paragraph (a)(2) of this section. (i) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(1), (b)(1), and (i) Industrial, commercial, and con- (c)(1). sumer activities. Requirements as speci- (ii) [Reserved] fied in § 721.80 (f), (j) (use other than as (b) Specific requirements. The provi- filler to reinforce resins, additive for sions of subpart A of this part apply to resins, and filter medium), (v)(1), and this section except as modified by this (x)(1). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), and (k) are applicable to manu- this section except as modified by this facturers, importers, and processors of paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (i) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of [72 FR 14700, Mar. 29, 2007] this substance.

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(2) Limitations or revocation of certain (b), (c), and (k) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this substance. (2) Limitations or revocation of certain [72 FR 14701, Mar. 29, 2007] notification requirements. The provisions § 721.10019 Benzoic acid, 2-chloro-5- of § 721.185 apply to this section. nitro-, 1,1-dimethyl-2-oxo-2-(2- [72 FR 14701, Mar. 29, 2007] propenyloxy) ethyl ester. (a) Chemical substance and significant § 721.10021 Magnesium potassium tita- new uses subject to reporting. (1) The nium oxide. chemical substance identified as ben- (a) Chemical substance and significant zoic acid, 2-chloro-5-nitro-, 1,1-di- new uses subject to reporting. (1) The methyl-2-oxo-2-(2-propenyloxy) ethyl chemical substance identified as mag- ester (PMN P–01–563; CAS No. 174489–76– nesium potassium titanium oxide 0) is subject to reporting under this (PMN P–01–764; CAS No. 39290–90–9) is section for the significant new uses de- subject to reporting under this section scribed in paragraph (a)(2) of this sec- for the significant new uses described tion. in paragraph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Release to water. Requirements as (i) Protection in the workplace. Re- specified § 721.90 (a)(1), (b)(1), and (c)(1). quirements as specified in § 721.63 (a)(4), (ii) [Reserved] (a)(6)(i), (b) (concentration set at 0.1 (b) Specific requirements. The provi- percent), and (c). The following Na- sions of subpart A of this part apply to tional Institute for Occupational Safe- this section except as modified by this ty and Health (NIOSH)-approved res- paragraph. pirators with an assigned protection (1) Recordkeeping. Recordkeeping re- factor (APF) of 10–25 meet the min- quirements as specified in § 721.125 (a), imum requirements for § 721.63(a)(4): (b), (c), and (k) are applicable to manu- Air-purifying, tight-fitting respirator facturers, importers, and processors of equipped with N100 (if aerosols absent), this substance. R100, or P100 filters (either half- or (2) Limitations or revocation of certain full-face); powered air-purifying res- notification requirements. The provisions pirator equipped with a loose-fitting of § 721.185 apply to this section. hood or helmet and High Efficiency [72 FR 14701, Mar. 29, 2007] Particulate Air (HEPA) filters; powered air-purifying respirator equipped § 721.10020 Benzoic acid, 5-amino-2- with a tight-fitting facepiece (either chloro-, 1,1-dimethyl-2-oxo-2-(2- half- or full-face) and HEPA filters; and propenyloxy) ethyl ester. supplied-air respirator operated in (a) Chemical substance and significant pressure demand or continuous flow new uses subject to reporting. (1) The mode and equipped with a hood or hel- chemical substance identified as ben- met or tight-fitting facepiece (either zoic acid, 5-amino-2-chloro-, 1,1-di- half- or full-face). As an alternative to methyl-2-oxo-2-(2-propenyloxy) ethyl the respiratory requirements listed ester (PMN P–01–564; CAS No. 174489–43– here, a manufacturer, importer, or 1) is subject to reporting under this processor may choose to follow the new section for the significant new uses de- chemical exposure limit (NCEL) provi- scribed in paragraph (a)(2) of this sec- sions listed in the TSCA section 5(e) tion. consent order for this substance. The (2) The significant new uses are: NCEL is 5 mg/m3 as an 8-hour time- (i) Release to water. Requirements as weighted average. Persons who wish to specified § 721.90 (a)(1), (b)(1), and (c)(1). pursue NCELs as an alternative to the (ii) [Reserved] § 721.63 respirator requirements may re- (b) Specific requirements. The provi- quest to do so under 40 CFR 721.30. Per- sions of subpart A of this part apply to sons whose § 721.30 requests to use the this section except as modified by this NCELs approach are approved by EPA paragraph. will receive NCELs provisions com- (1) Recordkeeping. Recordkeeping re- parable to those contained in the cor- quirements as specified in § 721.125 (a), responding section 5(e) consent order.

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(ii) Hazard communication program. (2) Limitations or revocation of certain Requirements as specified in § 721.72 (a), notification requirements. The provisions (b), (c), (d), (e) (concentration set 0.1 of § 721.185 apply to this section. percent), (f), (g)(1)(ii), (g)(2)(ii), [72 FR 14701, Mar. 29, 2007] (g)(2)(iv) (use respiratory protection or maintain workplace airborne con- § 721.10023 Benzenamine, N-phenyl-, centrations at or below an 8-hour time- ar ar′-(C9-rich C88-10-branched alkyl) weighted average of 5 mg/m3) and (g)(5). derivs. (iii) Industrial, commercial, and con- (a) Chemical substance and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80(q). chemical substance identified as (b) Specific requirements. The provi- benzenamine, N-phenyl-, ar,ar′-(C9-rich sions of subpart A of this part apply to C8-10-branched alkyl) derivs (PMN P–01– this section except as modified by this 770; CAS No. 333955–70–7) is subject to paragraph. reporting under this section for the sig- (1) Recordkeeping. Recordkeeping re- nificant new uses described in para- quirements as specified in § 721.125 (a), graph (a)(2) of this section. (b), (c), (d), (f), (g), (h), and (i) are appli- (2) The significant new uses are: cable to manufacturers, importers, and (i) Industrial, commercial, and con- processors of this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(j) (antioxidant for lubri- notification requirements. The provisions cating oils). of § 721.185 apply to this section. (ii) Release to water. Requirements as (3) Determining whether a specific use is specified in § 721.90 (a)(1), (b)(1), and subject to this section. The provisions of (c)(1). § 721.1725(b)(1) apply to this section. (b) Specific requirements. The provisions of subpart A of this part apply to [72 FR 14701, Mar. 29, 2007] this section except as modified by this paragraph. § 721.10022 Benzenamine, N-phenyl-, ′ (1) Recordkeeping. Recordkeeping re- ar -(C9-rich C8-10-branched alkyl) quirements as specified in § 721.125 (a), derivs. (b), (c), (i), and (k) are applicable to (a) Chemical substance and significant manufacturers, importers, and proc- new uses subject to reporting. (1) The essors of these substances. chemical substance identified as (2) Limitations or revocation of certain benzenamine, N-phenyl-, ar′-(C9-rich notification requirements. The provisions C8-10-branched alkyl) derivs (PMN P–01– of § 721.185 apply to this section. 769; CAS No. 333955–69–4) is subject to reporting under this section for the sig- [72 FR 14702, Mar. 29, 2007] nificant new uses described in para- § 721.10024 10H-Phenothiazine, ar-(C9- graph (a)(2) of this section. rich C8-10-branched alkyl) derivs. (2) The significant new uses are: (a) Chemical substance and significant (i) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified as 10H- fied in § 721.80(j) (antioxidant for lubri- phenothiazine, ar-(C9-rich C8-10- cating oils). branched alkyl) derivs (PMN P–01–771; (ii) Release to water. Requirements as CAS No. 333955–79–6) is subject to re- specified in § 721.90 (a)(1), (b)(1), and porting under this section for the sig- (c)(1). nificant new uses described in para- (b) Specific requirements. The provi- graph (a)(2) of this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Industrial, commercial, and con- paragraph. sumer activities. Requirements as speci- (1) Recordkeeping. Recordkeeping re- fied in § 721.80(j) (antioxidant for lubri- quirements as specified in § 721.125 (a), cating oils). (b), (c), (i), and (k) are applicable to (ii) Release to water. Requirements as manufacturers, importers, and proc- specified in § 721.90 (a)(1), (b)(1), and essors of these substances. (c)(1).

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(b) Specific requirements. The provi- (i) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Requirements as speci- this section except as modified by this fied in § 721.80(k) (any manufacturing, paragraph. processing, or use of the PMN sub- (1) Recordkeeping. Recordkeeping re- stance with less than 55 moles of the quirements as specified in § 721.125 (a), ethoxy or with an average molecular (b), (c), (i), and (k) are applicable to weight less than 2,700 daltons). manufacturers, importers, and proc- (ii) [Reserved] essors of these substances. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. [72 FR 14702, Mar. 29, 2007] (1) Recordkeeping. Recordkeeping re- ′ quirements as specified in § 721.125 (a), § 721.10025 10H-Phenothiazine, ar, ar - (b), (c), and (i) are applicable to manu- (C -rich C -branched alkyl) derivs. 9 8-10 facturers, importers, and processors of (a) Chemical substance and significant this substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substances identified as 10H- notification requirements. The provisions phenothiazine, ar, ar′-(C -rich C - 9 8-10 of § 721.185 apply to this section. branched alkyl) derivs (PMN P–01–772; CAS No. 333955–80–9) is subject to re- [72 FR 14702, Mar. 29, 2007] porting under this section for the significant new uses described in para- § 721.10027 Ethoxylated alkylsulfate, graph (a)(2) of this section. substituted alkylamine salt (ge- (2) The significant new uses are: neric). (i) Industrial, commercial, and con- (a) Chemical substance and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80(j) (antioxidant for lubri- chemical substance identified generi- cating oils). cally as ethoxylated alkylsulfate, sub- (ii) Release to water. Requirements as stituted alkylamine salt (PMN P–01– specified in § 721.90 (a)(1), (b)(1), and 862) is subject to reporting under this (c)(1). section for the significant new uses de- (b) Specific requirements. The provi- scribed in paragraph (a)(2) of this sec- sions of subpart A of this part apply to tion. this section except as modified by this paragraph. (2) The significant new uses are: (1) Recordkeeping. Recordkeeping re- (i) Industrial, commercial, and con- quirements as specified in § 721.125 (a), sumer activities. Requirements as speci- (b), (c), (i), and (k) are applicable to fied in § 721.80(j). manufacturers, importers, and proc- (ii) [Reserved] essors of these substances. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. [72 FR 14702, Mar. 29, 2007] (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), § 721.10026 Cashew, nutshell liq., (b), (c), and (i) are applicable to manu- ethoxylated. facturers, importers, and processors of (a) Chemical substance and significant this substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified as cash- notification requirements. The provisions ew, nutshell liq., ethoxylated (PMN P– of § 721.185 apply to this section. 01–856; CAS No. 350820–95–0) is subject (3) Determining whether a specific use is to reporting under this section for the subject to this section. The provisions of significant new uses described in para- § 721.1725(b)(1) apply to this section. graph (a)(2) of this section. (2) The significant new uses are: [72 FR 14702, Mar. 29, 2007]

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§ 721.10028 Disubstituted benzene tight-fitting full facepiece and High Ef- metal salts (generic). ficiency Particulate Air (HEPA) filters; (a) Chemical substances and significant supplied-air respirator operated in new uses subject to reporting. (1) The pressure demand or continuous flow chemical substances identified generi- mode and equipped with a tight-fitting cally as disubstituted benzene metal full facepiece. As an alternative to the salts (PMNs P–01–901 and P–01–902) are respiratory requirements listed here, a subject to reporting under this section manufacturer, importer, or processor for the significant new uses described may choose to follow the new chemical in paragraph (a)(2) of this section. exposure limit (NCEL) provisions listed (2) The significant new uses are: in the TSCA section 5(e) consent order (i) Protection in the workplace. Re- for this substance. The NCEL is 0.05 quirements as specified in § 721.63 (a)(1) mg/m3 as an 8-hour time-weighted aver- and (a)(3). age. Persons who wish to pursue NCELs (ii) Industrial, commercial, and con- as an alternative to the § 721.63 res- sumer activities. Requirements as specified in § 721.80(j). pirator requirements may request to do (b) Specific requirements. The provi- so under 40 CFR 721.30. Persons whose sions of subpart A of this part apply to § 721.30 requests to use the NCELs ap- this section except as modified by this proach are approved by EPA will re- paragraph. ceive NCELs provisions comparable to (1) Recordkeeping. Recordkeeping re- those contained in the corresponding quirements as specified in § 721.125 (a), section 5(e) consent order. (b), (c), (d), (e), and (i) are applicable to (ii) Hazard communication program. manufacturers, importers, and proc- Requirements as specified in § 721.72 (a), essors of this substance. (b), (c), (d), (e) (concentration set 1.0 (2) Limitations or revocation of certain percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), notification requirements. The provisions (g)(2)(ii), (g)(2)(iv) (use respiratory proof § 721.185 apply to this section. tection or maintain workplace airborne (3) Determining whether a specific use is concentrations at or below an 8-hour subject to this section. The provisions of time-weighted average of 0.05 mg/m3), § 721.1725(b)(1) apply to this section. (g)(2)(v), and (g)(5). The following [72 FR 14703, Mar. 29, 2007] statements shall appear on each label as specified in § 721.72(b) and the Mate- § 721.10029 Isocyanate compound, rial Safety Data Sheet (MSDS) as spec- modified with methoxysilane (generic). ified in § 721.72(c): This substance may cause skin irritation and sensitization. (a) Chemical substance and significant (iii) Industrial, commercial, and con- new uses subject to reporting. (1) The chemical substance identified generi- sumer activities. Requirements as speci- cally as isocyanate compound, modified in § 721.80(q). fied with methoxysilane (PMN P–01– (b) Specific requirements. The provi- 918) is subject to reporting under this sions of subpart A of this part apply to section for the significant new uses de- this section except as modified by this scribed in paragraph (a)(2) of this sec- paragraph. tion. (1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a), (i) Protection in the workplace. Re- (b), (c), (d), (e), (f), (g), (h), and (i) are quirements as specified in § 721.63 (a)(1), applicable to manufacturers, import- (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(2)(iv), ers, and processors of this substance. (a)(3), (a)(4), and (a)(6). The following (2) Limitations or revocation of certain National Institute for Occupational notification requirements. The provisions Safety and Health (NIOSH)-approved of § 721.185 apply to this section. respirators meet the minimum require- (3) Determining whether a specific use is ment for § 721.63(a)(4): Air-purifying, tight-fitting full-face respirator subject to this section. The provisions of equipped with N100 (if oil aerosols ab- § 721.1725(b)(1) apply to this section. sent), R100, or P100 filters; powered air- [72 FR 14703, Mar. 29, 2007] purifying respirator equipped with a

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§ 721.10030 Pyrimido[5,4-g]pteridine- face) and High Efficiency Particulate 2,4,6,8-tetramine, 4- Air (HEPA) filters; and supplied-air methylbenzenesulfonate, base- respirator operated in pressure demand hydrolyzed. or continuous flow mode and equipped (a) Chemical substance and significant with a hood or helmet or tight-fitting new uses subject to reporting. (1) The facepiece (either half- or full-face). As chemical substance identified as an alternative to the respiratory re- pyrimido[5,4-g]pteridine-2,4,6,8-tetra- quirements listed here, a manufac- mine, 4-methylbenzenesulfonate, base- turer, importer, or processor may hydrolyzed (PMN P–01–919; CAS No. choose to follow the new chemical ex- 346709–25–9) is subject to reporting posure limit (NCEL) provisions listed under this section for the significant in the TSCA section 5(e) consent order new uses described in paragraph (a)(2) for this substance. The NCEL is 5 mg/ of this section. m3 as an 8-hour time-weighted average. (2) The significant new uses are: Persons who wish to pursue NCELs as (i) Industrial, commercial, and con- an alternative to the § 721.63 respirator sumer activities. Requirements as speci- requirements may request to do so fied in § 721.80(f). under 40 CFR 721.30. Persons whose (ii) [Reserved] § 721.30 requests to use the NCELs ap- (b) Specific requirements. The provi- proach are approved by EPA will re- sions of subpart A of this part apply to ceive NCELs provisions comparable to this section except as modified by this those contained in the corresponding paragraph. section 5(e) consent order. (1) Recordkeeping. Recordkeeping re- (ii) Hazard communication program. quirements as specified in § 721.125 (a), Requirements as specified in § 721.72 (a), (b), (c), and (i) are applicable to manu- (b), (c), (d), (e) (concentration set 0.1 facturers, importers, and processors of percent), (f), (g)(1)(ii), (g)(2)(ii), this substance. (g)(2)(iv) (use respiratory protection or (2) Limitations or revocation of certain maintain workplace airborne con- notification requirements. The provisions centrations at or below an 8-hour time- of § 721.185 apply to this section. weighted average of 5 mg/m3), and [72 FR 14703, Mar. 29, 2007] (g)(5). (iii) Industrial, commercial, and con- § 721.10031 Lithium potassium tita- sumer activities. Requirements as speci- nium oxide. fied in § 721.80(q). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified as lith- this section except as modified by this ium potassium titanium oxide (PMN P– paragraph. 02–214; CAS No. 39318–30–4) is subject to (1) Recordkeeping. Recordkeeping re- reporting under this section for the sig- quirements as specified in § 721.125 (a), nificant new uses described in para- (b), (c), (d), (f), (g), (h), and (i) are appli- graph (a)(2) of this section. cable to manufacturers, importers, and (2) The significant new uses are: processors of this substance. (i) Protection in the workplace. Re- (2) Limitations or revocation of certain quirements as specified in § 721.63 (a)(4), notification requirements. The provisions (a)(6)(i), (b) (concentration set at 0.1 of § 721.185 apply to this section. percent), and (c). The following Na- (3) Determining whether a specific use is tional Institute for Occupational Safe- subject to this section. The provisions of ty and Health (NIOSH)-approved res- § 721.1725(b)(1) apply to this section. pirators with an APF of 10–25 meet the [72 FR 14703, Mar. 29, 2007] minimum requirements for § 721.63(a)(4): Air-purifying, tight-fit- § 721.10032 Acrylic acid, polymer with ting respirator (either half- or full- substituted acrylamides (generic). face) equipped with N100 (if aerosols (a) Chemical substance and significant absent), R100, or P100 filters; powered new uses subject to reporting. (1) The air-purifying, respirator equipped with chemical substance identified generi- a loose-fitting hood or helmet or tight- cally as acrylic acid, polymer with sub- fitting facepiece (either half- or full- stituted acrylamides (PMN P–02–269) is

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subject to reporting under this section § 721.10034 Substituted pyridine cou- for the significant new uses described pled with diazotized substituted in paragraph (a)(2) of this section. nitrobenzonitrile, diazotized sub- (2) The significant new uses are: stituted benzenamine and substituted pyridinecarbonitrile (ge- (i) Industrial, commercial, and con- neric). sumer activities. Requirements as specified in § 721.80(k) (any manufacturing, (a) Chemical substance and significant new uses subject to reporting. (1) The processing, or use of the PMN sub- chemical substance identified generi- stance with an aerodynamic diameter cally as substituted pyridine coupled less than 10 microns). with diazotized substituted (ii) [Reserved] nitrobenzonitrile, diazotized sub- (b) Specific requirements. The provi- stituted benzenamine and substituted sions of subpart A of this part apply to pyridinecarbonitrile (PMN P–02–359) is this section except as modified by this subject to reporting under this section paragraph. for the significant new uses described (1) Recordkeeping. Recordkeeping rein paragraph (a)(2) of this section. quirements as specified in § 721.125 (a), (2) The significant new uses are: (b), (c), and (i) are applicable to manu- (i) Release to water. Requirements as facturers, importers, and processors of specified § 721.90 (a)(4), (b)(4), and (c)(4) this substance. (N=1). (2) Limitations or revocation of certain (ii) [Reserved] notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to this section except as modified by this [72 FR 14704, Mar. 29, 2007] paragraph. (1) Recordkeeping. Recordkeeping re- § 721.10033 Zinc, [ethanedioato(2-)-. kappa. O1, . kappa. O2]-. quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (a) Chemical substance and significant facturers, importers, and processors of new uses subject to reporting. (1) The this substance. chemical substance identified as zinc, (2) Limitations or revocation of certain [ethanedioato(2-)-. kappa. O1, . kappa. notification requirements. The provisions O2]- (PMN P–02–322; CAS No. 547–68–2) is of § 721.185 apply to this section. subject to reporting under this section [72 FR 14704, Mar. 29, 2007] for the significant new uses described in paragraph (a)(2) of this section. § 721.10035 Alkylbenzene sulfonate (ge- (2) The significant new uses are: neric). (i) Release to water. Requirements as (a) Chemical substance and significant specified § 721.90 (a)(4), (b)(4), and (c)(4) new uses subject to reporting. (1) The (N=1). chemical substance identified generi- (ii) [Reserved] cally as alkylbenzene sulfonate (PMN– (b) Specific requirements. The provi- 02–382) is subject to reporting under sions of subpart A of this part apply to this section for the significant new this section except as modified by this uses described in paragraph (a)(2) of paragraph. this section. (1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a), (i) Industrial, commercial, and con- (b), (c), and (k) are applicable to manu- sumer activities. Requirements as speci- facturers, importers, and processors of fied in § 721.80(k) (manufacture, import, this substance. or processing of the chemical without (2) Limitations or revocation of certain 19 percent or more mineral oil as a dil- notification requirements. The provisions uent). of § 721.185 apply to this section. (ii) [Reserved] (b) Specific requirements. The provi- [72 FR 14704, Mar. 29, 2007] sions of subpart A of this part apply to this section except as modified by this paragraph.

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(1) Recordkeeping. Recordkeeping re- (ii) Release to water. Requirements as quirements as specified in § 721.125 (a), specified in § 721.90 (a)(4), (b)(4), and (b), (c), and (i) are applicable to manu- (c)(4) (N=1). facturers, importers, and processors of (b) Specific requirements. The provi- this substance. sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this section. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), [72 FR 14704, Mar. 29, 2007] (b), (c), (i), and (k) are applicable to manufacturers, importers, and proc- § 721.10036 Acetaldehyde based polymer (generic). essors of this substance. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generically as acetaldehyde based polymer [705, Mar. 29, 2007] (PMN P–02–406) is subject to reporting under this section for the significant § 721.10038 Trimellitic anhydride, new uses described in paragraph (a)(2) polymer with substituted glycol, alkyl phenols and ethoxylated of this section. nonylphenol (generic). (2) The significant new uses are: (a) Chemical substance and significant (i) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified generi- fied in § 721.80(f). cally as trimellitic anhydride, polymer (ii) Release to water. Requirements as with substituted glycol, alkyl phenols specified § 721.90 (b)(1) and (c)(1). and ethoxylated nonylphenol (PMN P– (b) Specific requirements. The provi- 02–434) is subject to reporting under sions of subpart A of this part apply to this section for the significant new this section except as modified by this uses described in paragraph (a)(2) of paragraph. this section. (1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a), (i) Release to water. Requirements as (b), (c), (i), and (k) are applicable to specified § 721.90 (a)(1), (b)(1), and (c)(1). manufacturers, importers, and proc- (ii) [Reserved] essors of this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. [72 FR 14704, Mar. 29, 2007] (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), § 721.10037 Complex halogenated salt (b), (c), and (k) are applicable to manu- of facturers, importers, and processors of tris(ethylatedaminocarbocyclic) this substance. methane (generic). (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generi- [72 FR 14697, Mar. 29, 2007] cally as complex halogenated salt of tris(ethylatedaminocarbocyclic)meth- § 721.10039 Diethoxybenzenamine de- ane (PMN P–02–423) is subject to re- rivative, diazotized, coupled with porting under this section for the sig- aminonaphthalenesulfonic acid de- nificant new uses described in para- rivative, ammonium salt (generic). graph (a)(2) of this section. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Industrial, commercial, and con- chemical substance identified generi- sumer activities. Requirements as speci- cally as a diethoxybenzenamine deriva- fied in § 721.80 (d) and (e). tive, diazotized, coupled with

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aminonaphthalenesulfonic acid deriva- § 721.10041 1-Butanone, 2- tive, ammonium salt (PMN P–02–514) is (dimethylamino)-2-[(4- subject to reporting under this section methylphenyl)methyl]-1-[4-(4- for the significant new uses described morpholinyl)phenyl]-. in paragraph (a)(2) of this section. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Industrial, commercial, and con- chemical substance identified as 1-bu- sumer activities. Requirements as speci- tanone, 2-(dimethylamino)-2-[(4- fied in § 721.80 (f), (v)(2), and (x)(2). methylphenyl)methyl]-1-[4-(4- (ii) [Reserved] morpholinyl)phenyl]-(PMN P–02–530; (b) Specific requirements. The provi- CAS No. 119344–86–4) is subject to re- sions of subpart A of this part apply to porting under this section for the sig- this section except as modified by this nificant new uses described in para- paragraph. graph (a)(2) of this section. (2) The significant new uses are: (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (i) Industrial, commercial, and con- (b), (c), and (i) are applicable to manu- sumer activities. Requirements as specified in § 721.80(f). facturers, importers, and processors of this substance. (ii) [Reserved] (b) . The provi- (2) Limitations or revocation of certain Specific requirements sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. [72 FR 14705, Mar. 29, 2007] (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), § 721.10040 Substituted acridine naph- (b), (c), and (i) are applicable to manu- tha substituted benzamide (ge- facturers, importers, and processors of neric). this substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance identified generi- of § 721.185 apply to this section. cally as a substituted acridine naphtha [72 FR 14705, Mar. 29, 2007] substituted benzamide (PMN P–02–522) is subject to reporting under this sec- § 721.10042 2-Propanol, 1-[bis(2-hy- tion for the significant new uses de- droxyethyl)amino]-. scribed in paragraph (a)(2) of this sec- (a) Chemical substance and significant tion. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified as 2-pro- (i) Release to water. Requirements as panol, 1-[bis(2-hydroxyethyl)amino]- specified § 721.90 (a)(4), (b)(4), and (c)(4) (PMN P–02–585; CAS No. 6712–98–7) is (N=2). subject to reporting under this section (ii) [Reserved] for the significant new uses described (b) Specific requirements. The provi- in paragraph (a)(2) of this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Industrial, commercial, and con- paragraph. sumer activities. Requirements as speci- (1) Recordkeeping. Recordkeeping re- fied in § 721.80(j). quirements as specified in § 721.125 (a), (ii) [Reserved] (b), (c), and (k) are applicable to manu- (b) Specific requirements. The provi- facturers, importers, and processors of sions of subpart A of this part apply to this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- [72 FR 14705, Mar. 29, 2007] facturers, importers, and processors of this substance.

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(2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this (3) Determining whether a specific use is paragraph. subject to this section. The provisions of (1) Recordkeeping. Recordkeeping re- § 721.1725(b)(1) apply to this section. quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- [72 FR 14705, Mar. 29, 2007] facturers, importers, and processors of § 721.10043 Dineopentyl-4-substituted this substance. phthalate (generic). (2) Limitations or revocation of certain notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The chemical substance identified generi- [72 FR 14706, Mar. 29, 2007] cally as dineopentyl-4-substituted § 721.10045 Diazotized substituted phthalate (PMN P–02–697) is subject to heteromonocycle coupled with reporting under this section for the sig- naphthalene sulfonic acid deriva- nificant new uses described in para- tive, nickel complex, alkaline salt graph (a)(2) of this section. (generic). (2) The significant new uses are: (a) Chemical substance and significant (i) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified generi- fied in § 721.80(j). cally as a diazotized substituted (ii) Release to water. Requirements as heteromonocycle coupled with naph- specified § 721.90 (a)(1), (b)(1), and (c)(1). thalene sulfonic acid derivative, nickel (b) Specific requirements. The provi- complex, alkaline salt (PMN P–02–737) sions of subpart A of this part apply to is subject to reporting under this sec- this section except as modified by this tion for the significant new uses de- paragraph. scribed in paragraph (a)(2) of this sec- (1) Recordkeeping. Recordkeeping re- tion. quirements as specified in § 721.125 (a), (2) The significant new uses are: (b), (c), (i), and (k) are applicable to (i) Industrial, commercial, and con- manufacturers, importers, and proc- sumer activities. Requirements as speci- essors of this substance. fied in § 721.80 (f), (v)(2), and (x)(2). (2) Limitations or revocation of certain (ii) [Reserved] notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to (3) Determining whether a specific use is this section except as modified by this subject to this section. The provisions of paragraph. § 721.1725(b)(1) apply to this section. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), [72 FR 14705, Mar. 29, 2007] (b), (c), and (i) are applicable to manu- § 721.10044 Metal oxide, modified with facturers, importers, and processors of alkyl and vinyl terminated this substance. polysiloxanes (generic). (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generi- [72 FR 14706, Mar. 29, 2007] cally as metal oxide, modified with alkyl and vinyl terminated § 721.10046 Polyaromatic amine phos- polysiloxanes (PMN P–02–698) is subject phate (generic). to reporting under this section for the (a) Chemical substance and significant significant new uses described in para- new uses subject to reporting. (1) The graph (a)(2) of this section. chemical substance identified generi- (2) The significant new uses are: cally as polyaromatic amine phosphate (i) Industrial, commercial, and con- (PMN P–02–747) is subject to reporting sumer activities. Requirements as speci- under this section for the significant fied in § 721.80 (v)(1), (w)(1), and (x)(1). new uses described in paragraph (a)(2) (ii) [Reserved] of this section.

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(2) The significant new uses are: under this section for the significant (i) Release to water. Requirements as new uses described in paragraph (a)(2) specified § 721.90 (a)(1), (b)(1), and (c)(1). of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Industrial, commercial, and con- sions of subpart A of this part apply to sumer activities. Requirements as speci- this section except as modified by this fied in § 721.80(s) (4,500 kilograms). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), and (k) are applicable to manu- this section except as modified by this facturers, importers, and processors of paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (i) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of this substance. [72 FR 14706, Mar. 29, 2007] (2) Limitations or revocation of certain § 721.10047 Polyphosphoric acids, notification requirements. The provisions compds. with piperazine. of § 721.185 apply to this section. (a) Chemical substance and significant [72 FR 14706, Mar. 29, 2007] new uses subject to reporting. (1) The chemical substance identified as a § 721.10049 Phenol, 4,4′- polyphosphoric acids, compds. with pi- cyclohexylidene bis[2-methyl-. perazine (PMN P–02–766; CAS No. (a) Chemical substance and significant 383905–85–9) is subject to reporting new uses subject to reporting. (1) The under this section for the significant chemical substance identified as a phe- new uses described in paragraph (a)(2) nol, 4,4′- cyclohexylidene bis[2-methyl- of this section. (PMN P–02–912; CAS No. 2362–14–3) is (2) The significant new uses are: subject to reporting under this section (i) Industrial, commercial, and con- for the significant new uses described sumer activities. Requirements as speci- in paragraph (a)(2) of this section. fied in § 721.80(j). (2) The significant new uses are: (ii) [Reserved] (i) Release to water. Requirements as (b) Specific requirements. The provi- specified § 721.90 (a)(1), (b)(1), and (c)(1). sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125 (a), paragraph. (b), (c), and (i) are applicable to manu- (1) Recordkeeping. Recordkeeping re- facturers, importers, and processors of quirements as specified in § 721.125 (a), this substance. (b), (c), and (k) are applicable to manu- (2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain (3) Determining whether a specific use is notification requirements. The provisions subject to this section. The provisions of of § 721.185 apply to this section. § 721.1725(b)(1) apply to this section. [72 FR 14706, Mar. 29, 2007] [72 FR 14706, Mar. 29, 2007] § 721.10050 Disubstituted-N′- hydroxy- § 721.10048 Substituted anthraquinone benzenecarboximidamide (generic). (generic). (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance identified generically as disubstituted-N′- hydroxy- cally as substituted anthraquinone benzenecarboximidamide (PMN P–02– (PMN P–02–869) is subject to reporting 929) is subject to reporting under this

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section for the significant new uses de- to reporting under this section for the scribed in paragraph (a)(2) of this sec- significant new uses described in para- tion. graph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Industrial, commercial, and con- (i) Industrial, commercial, and consumer activities. Requirements as speci- sumer activities. Requirements as specified in § 721.80(g). fied in § 721.80(j). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- (b), (c), and (i) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. (3) Determining whether a specific use is [72 FR 14707, Mar. 29, 2007] subject to this section. The provisions of § 721.1725(b)(1) apply to this section. § 721.10051 Spiro naphthoxazine (generic). [72 FR 14707, Mar. 29, 2007] (a) Chemical substance and significant § 721.10053 Alkyl silane methacrylate new uses subject to reporting. (1) The (generic). chemical substance identified generi- (a) Chemical substance and significant cally as spiro naphthoxazine (PMN P– new uses subject to reporting. (1) The 02–961) is subject to reporting under chemical substance identified generi- this section for the significant new cally as alkyl silane methacrylate uses described in paragraph (a)(2) of (PMN P–03–41) is subject to reporting this section. under this section for the significant (2) The significant new uses are: new uses described in paragraph (a)(2) (i) Industrial, commercial, and con- of this section. sumer activities. Requirements as speci- (2) The significant new uses are: fied in § 721.80(f). (i) Release to water. Requirements as (ii) [Reserved] specified § 721.90 (a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provi- (ii) [Reserved] sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), and (i) are applicable to manu- quirements as specified in § 721.125 (a), facturers, importers, and processors of (b), (c), and (k) are applicable to manu- this substance. facturers, importers, and processors of (2) Limitations or revocation of certain this substance. notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions [72 FR 14707, Mar. 29, 2007] of § 721.185 apply to this section. [72 FR 14707, Mar. 29, 2007] § 721.10052 Aminoalkyl substituted alkylphenol (generic). § 721.10054 Phenol, polymer with form- (a) Chemical substance and significant aldehyde, 3-[(2- new uses subject to reporting. (1) The aminocyclohexyl)amino]-2- chemical substance identified generi- hydroxypropyl ethers. cally as aminoalkyl substituted (a) Chemical substance and significant alkylphenol (PMN P–02–1088) is subject new uses subject to reporting. (1) The

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chemical substance identified generi- (3) Determining whether a specific use is cally as a phenol, polymer with form- subject to this section. The provisions of aldehyde, 3-[(2- § 721.1725(b)(1) apply to this section. aminocyclohexyl)amino]-2- [72 FR 14707, Mar. 29, 2007] hydroxypropyl ethers (PMN P–03–43; CAS No. 452082–53–0) is subject to re- § 721.10056 Benzenemethanaminium, porting under this section for the sig- N-(3-aminopropyl)-N,N-dimethyl-, N- nificant new uses described in para- soya acyl derivs., chlorides. graph (a)(2) of this section. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Release to water. Requirements as chemical substance identified as specified § 721.90 (a)(1), (b)(1), and (c)(1). benzenemethanaminium, N-(3- (ii) [Reserved] aminopropyl)-N,N-dimethyl-, N-soya (b) Specific requirements. The provi- acyl derivs., chlorides (PMN P–03–47; sions of subpart A of this part apply to CAS No. 90194–13–1) is subject to report- this section except as modified by this ing under this section for the signifi- paragraph. cant new uses described in paragraph (1) Recordkeeping. Recordkeeping re- (a)(2) of this section. quirements as specified in § 721.125 (a), (2) The significant new uses are: (b), (c), and (k) are applicable to manu- (i) Industrial, commercial, and con- facturers, importers, and processors of sumer activities. Requirements as speci- this substance. fied in § 721.80(j). (2) Limitations or revocation of certain (ii) [Reserved] notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to this section except as modified by this [72 FR 14707, Mar. 29, 2007] paragraph. (1) Recordkeeping. Recordkeeping re- § 721.10055 1-Propanaminium, 3- quirements as specified in § 721.125 (a), amino-N-(carboxymethyl)-N,N-di- (b), (c), and (i) are applicable to manu- methyl-, N-soya acyl derivs., inner facturers, importers, and processors of salts. this substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance identified as 1- of § 721.185 apply to this section. propanaminium, 3-amino-N- (3) Determining whether a specific use is (carboxymethyl)-N,N-dimethyl-, N-soya subject to this section. The provisions of acyl derivs., inner salts (PMN P–03–46; § 721.1725(b)(1) apply to this section. CAS No. 136504–87–5) is subject to reporting under this section for the sig- [72 FR 14708, Mar. 29, 2007] nificant new uses described in para- § 721.10057 Dodecanedioic acid, 1, 12- graph (a)(2) of this section. dihydrazide. (2) The significant new uses are: (a) Chemical substance and significant (i) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified as fied in § 721.80(j). dodecanedioic acid, 1, 12-dihydrazide (ii) [Reserved] (PMNs P–01–759 and P–05–555; CAS No. (b) Specific requirements. The provi- 4080–98–2) is subject to reporting under sions of subpart A of this part apply to this section for the significant new this section except as modified by this uses described in paragraph (a)(2) of paragraph. this section. (1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a), (i) Protection in the workplace. Re- (b), (c), and (i) are applicable to manu- quirements as specified in § 721.63 (a)(1), facturers, importers, and processors of (a)(2)(i), (a)(3), (a)(4), (a)(5), (a)(6)(i), this substance. (a)(6)(ii), (b), and (c). Respirators must (2) Limitations or revocation of certain provide a National Institute for Occu- notification requirements. The provisions pational Safety and Health (NIOSH) as- of § 721.185 apply to this section. signed protection factor (APF) of at

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least 50. The following NIOSH-approved (b), (c), and (k) are applicable to manu- respirators meet the minimum require- facturers, importers, and processors of ment for § 721.63(a)(4): Air-purifying, this substance. tight-fitting full-face respirator (2) Limitations or revocation of certain equipped with N100 (if oil aerosols ab- notification requirements. The provisions sent), R100, or P100 filters; powered air- of § 721.185 apply to this section. purifying respirator equipped with a [72 FR 53482, Sept. 19, 2007] tight-fitting full facepiece and High Ef- ficiency Particulate Air (HEPA) filters; § 721.10059 Reaction product of supplied air respirator operated in alkylphenyl glycidyl ether, pressure demand or continuous flow polyalkylenepolyamine, and alkyl mode and equipped with a tight-fitting diglycidyl dibenzene (generic). full facepiece. Because the substance is (a) Chemical substance and significant a dermal sensitizer and irritates mu- new uses subject to reporting. (1) The cous membranes, half-face respirators chemical substance identified generi- do not provide adequate protection. cally as reaction product of (ii) Hazard communication program. alkylphenyl glycidyl ether, Requirements as specified in § 721.72 (a), polyalkylenepolyamine, and alkyl (b), (c), (d), (e) (concentration set at 0.1 diglycidyl dibenzene (PMN P–03–550) is percent), (f), (g)(1)(i), and (g)(2)(i). subject to reporting under this section (b) Specific requirements. The provi- for the significant new uses described sions of subpart A of this part apply to in paragraph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Release to water. Requirements as (1) Recordkeeping. Recordkeeping re- specified in § 721.90 (a)(1), (b)(1), and quirements as specified in § 721.125 (a), (c)(1). (b), (c), (d), (e), (f), (g), and (h) are ap- (ii) [Reserved] plicable to manufacturers, importers, (b) Specific requirements. The provi- and processors of this substance. sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this section. (1) Recordkeeping. Recordkeeping re- [74 FR 32465, July 8, 2009] quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- § 721.10058 Reaction product of facturers, importers, and processors of alkylphenol, aromatic cyclicamine, this substance. alkyl diglycidyl dibenzene, and (2) Limitations or revocation of certain formaldehyde (generic). notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The [72 FR 53482, Sept. 19, 2007] chemical substance identified generically as reaction product of § 721.10060 Reaction product of alkylphenol, aromatic cyclicamine, alkylphenyl glycidyl ether, alkyl diglycidyl dibenzene, and form- polyalkylenepolyamine, alkyl aldehyde (PMN P–03–546) is subject to diglycidyl dibenzene, and reporting under this section for the sig- polyalkylcyclicdiamine (generic). nificant new uses described in para- (a) Chemical substance and significant graph (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified generi- (i) Release to water. Requirements as cally as reaction product of specified in § 721.90 (a)(1), (b)(1), and alkylphenyl glycidyl ether, (c)(1). polyalkylenepolyamine, alkyl (ii) [Reserved] diglycidyl dibenzene, and (b) Specific requirements. The provi- polyalkylcyclicdiamine (PMN P–03–551) sions of subpart A of this part apply to is subject to reporting under this sec- this section except as modified by this tion for the significant new uses de- paragraph. scribed in paragraph (a)(2) of this sec- (1) Recordkeeping. Recordkeeping re- tion. quirements as specified in § 721.125 (a), (2) The significant new uses are:

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(i) Release to water. Requirements as nificant new uses described in para- specified in § 721.90 (a)(1), (b)(1), and graph (a)(2) of this section. (c)(1). (2) The significant new uses are: (ii) [Reserved] (i) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(1), (b)(1), and sions of subpart A of this part apply to (c)(1). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), and (k) are applicable to manu- paragraph. facturers, importers, and processors of (1) Recordkeeping. Recordkeeping re- this substance. quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), and (k) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this substance. (2) Limitations or revocation of certain [72 FR 53482, Sept. 19, 2007] notification requirements. The provisions § 721.10061 Pentane, 1,1,1,2,2,3,4,5,5,5- of § 721.185 apply to this section. decafluoro-3-methoxy-4- [72 FR 53482, Sept. 19, 2007] (trifluoromethyl)-. (a) Chemical substance and significant § 721.10063 Halo substituted hydroxy new uses subject to reporting. (1) The nitrophenyl amide (generic). chemical substance identified as pen- (a) Chemical substance and significant tane, 1,1,1,2,2,3,4,5,5,5-decafluoro-3- new uses subject to reporting. (1) The methoxy-4-(trifluoromethyl)- (PMN P– chemical substance identified generi- 04–341; CAS No. 132182–92–4) is subject cally as halo substituted hydroxy to reporting under this section for the nitrophenyl amide (PMN P–04–792) is significant new uses described in para- subject to reporting under this section graph (a)(2) of this section. for the significant new uses described (2) The significant new uses are: in paragraph (a)(2) of this section. (i) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(1), (b)(1), and (i) Release to water. Requirements as (c)(1). specified in § 721.90 (a)(1), (b)(1), and (ii) [Reserved] (c)(1). (b) Specific requirements. The provi- (ii) [Reserved] sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), and (k) are applicable to manu- quirements as specified in § 721.125 (a), facturers, importers, and processors of (b), (c), and (k) are applicable to manu- this substance. facturers, importers, and processors of (2) Limitations or revocation of certain this substance. notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions of § 721.185 apply to this section. [72 FR 53482, Sept. 19, 2007] [72 FR 53482, Sept. 19, 2007] § 721.10062 2,5-Furandione, polymer with oxybis[propanol], benzoate. § 721.10064 2-Propenoic acid, 2-[2- (a) Chemical substance and significant (ethenyloxy)ethoxy]ethyl ester. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified as 2,5- new uses subject to reporting. (1) The furandione, polymer with chemical substance identified as 2-pro- oxybis[propanol], benzoate (PMN P–04– penoic acid, 2-[2- 627; CAS No. 103458–14–6) is subject to (ethenyloxy)ethoxy]ethyl ester (PMN reporting under this section for the sig- P–04–909; CAS No. 86273–46–3) is subject

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to reporting under this section for the (1) Recordkeeping. Recordkeeping re- significant new uses described in para- quirements as specified in § 721.125 (a), graph (a)(2) of this section. (b), (c), and (k) are applicable to manu- (2) The significant new uses are: facturers, importers, and processors of (i) Protection in the workplace. Re- this substance. quirements as specified in § 721.63 (a)(1), (2) Limitations or revocation of certain (a)(2)(i), (a)(3)(i), (b), and (c). North notification requirements. The provisions Butyl Black gloves and T-1 Dailove of § 721.185 apply to this section. Ethylene Vinylalcohol Copolymer [72 FR 53483, Sept. 19, 2007] Laminated Blue gloves have been demonstrated to satisfy (a)(3)(i). Other § 721.10066 1-Hexanesulfonic acid, demonstrated impervious gloves that (dimethylphenyl)-. satisfy (a)(3)(i) are also permissible. (a) Chemical substance and significant (ii) Hazard communication program. new uses subject to reporting. (1) The Requirements as specified in § 721.72 (a), chemical substance identified as 1- (b), (c), (d), (f), (g)(1)(i), (g)(1)(iv), hexanesulfonic acid, (dimethylphenyl)- (g)(1)(vi), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (PMN P–04–962; CAS No. 676143–36–5) is (g)(2)(iii), (g)(2)(v), and (g)(5). subject to reporting under this section (iii) Industrial, commercial, and con- for the significant new uses described sumer activities. Requirements as speci- in paragraph (a)(2) of this section. fied in § 721.80(q). (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(1), (b)(1), and this section except as modified by this (c)(1). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), (d), (e), (f), (g), (h), and (i) are this section except as modified by this applicable to manufacturers, import- paragraph. ers, and processors of this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of (3) Determining whether a specific use is this substance. subject to this section. The provisions of (2) Limitations or revocation of certain § 721.1725(b)(1) apply to this section. notification requirements. The provisions [72 FR 53482, Sept. 19, 2007] of § 721.185 apply to this section. [72 FR 53483, Sept. 19, 2007] § 721.10065 1-Tetradecanesulfonic acid, (dimethylphenyl)-. § 721.10067 Ether amine phosphonate (a) Chemical substance and significant salt (generic). new uses subject to reporting. (1) The (a) Chemical substances and significant chemical substance identified as 1- new uses subject to reporting. (1) The tetradecanesulfonic acid, chemical substances identified generi- (dimethylphenyl)- (PMN P–04–961; CAS cally as ether amine phosphonate salt No. 671756–61–9) is subject to reporting (PMNs P–05–57, P–05–58, P–05–59, P–05– under this section for the significant 61, P–05–62, P–05–63, P–05–64, and P–05– new uses described in paragraph (a)(2) 65) are subject to reporting under this of this section. section for the significant new uses de- (2) The significant new uses are: scribed in paragraph (a)(2) of this sec- (i) Release to water. Requirements as tion. specified in § 721.90 (a)(1), (b)(1), and (2) The significant new uses are: (c)(1). (i) Release to water. Requirements as (ii) [Reserved] specified in § 721.90 (a)(1), (b)(1), and (b) Specific requirements. The provi- (c)(1). sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to

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this section except as modified by this motor vehicles that were manufactured paragraph. after January 1, 2003. (1) Recordkeeping. Recordkeeping re- (vii) Manufacturing or processing of quirements as specified in § 721.125 (a), elemental mercury for use in flow me- (b), (c), and (k) are applicable to manu- ters, natural gas manometers, and facturers, importers, and processors of pyrometers except for use in these arti- this substance. cles when they are in service as of Sep- (2) Limitations or revocation of certain tember 11, 2009. notification requirements. The provisions (c) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to [72 FR 53483, Sept. 19, 2007] this section except as modified by this paragraph. § 721.10068 Elemental mercury. (1) Suspension or revocation of certain (a) Definitions. The definitions in notification exemptions. The provisions § 721.3 apply to this section. In addi- of § 721.45(f) do not apply to this section, the following definitions apply: tion. A person who imports or proc- Flow meter means an instrument used esses elemental mercury as part of an in various applications to measure the article is not exempt from submitting flow rate of liquids or gases. a significant new use notice. Motor vehicle has the meaning found (2) [Reserved] at 40 CFR 85.1703. Natural gas manometer means an in- [72 FR 56911, Oct. 5, 2007, as amended at 75 FR 42336, July 21, 2010] strument used in the natural gas industry to measure gas pressure. § 721.10069 Ether amine phosphonate Pyrometer means an instrument used (generic). in various applications to measure ex- tremely high temperatures. (a) Chemical substance and significant (b) Chemical substances and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substance identified generi- chemical substance elemental mercury cally as ether amine phosphonate (CAS. No. 7439–97–6) is subject to re- (PMN P–05–60) is subject to reporting porting under this section for the sig- under this section for the significant nificant new uses described in para- new uses described in paragraph (a)(2) graph (b)(2) of this section. of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Manufacture or processing of ele- (i) Release to water. Requirements as mental mercury for use in convenience specified in § 721.90 (a)(1), (b)(1), and light switches in new motor vehicles. (c)(1). (ii) Manufacture or processing of ele- (ii) [Reserved] mental mercury for use in convenience (b) Specific requirements. The provi- light switches as new aftermarket re- sions of subpart A of this part apply to placement parts for motor vehicles. this section except as modified by this (iii) Manufacture or processing of ele- paragraph. mental mercury for use in switches in (1) Recordkeeping. Recordkeeping re- anti-lock brake systems (ABS) in new quirements as specified in § 721.125 (a), motor vehicles. (b), (c), and (k) are applicable to manu- (iv) Manufacture or processing of ele- facturers, importers, and processors of mental mercury for use in switches in this substance. ABS as new aftermarket replacement (2) Limitations or revocation of certain parts for motor vehicles that were notification requirements. The provisions manufactured after January 1, 2003. of § 721.185 apply to this section. (v) Manufacture or processing of elemental mercury for use in switches in [72 FR 53483, Sept. 19, 2007] active ride control systems in new motor vehicles. § 721.10070 1,3-Butanediol, 3-methyl-. (vi) Manufacture or processing of ele- (a) Chemical substance and significant mental mercury for use in switches in new uses subject to reporting. (1) The active ride control systems as new chemical substance identified as 1,3- aftermarket replacement parts for butanediol, 3-methyl- (PMN P–05–309;

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CAS No. 2568–33–4) is subject to report- § 721.10072 Benzene, 1,1′- ing under this section for the signifi- methylenebis[4-isocyanato-, poly- cant new uses described in paragraph mer with benzenedicarboxylic acid, (a)(2) of this section. butyl dialkyl ester, (2) The significant new uses are: poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-hydroxy-, (i) Industrial, commercial, and con- oxirane, alkyl-, polymer with sumer activities. Requirements as speci- oxirane, ether with propanepolyol fied in § 721.80 (f) and (j)(use as inkjet and Sartomer’s HLBH P-3000 and ink). Lexorez 1180 (generic). (ii) [Reserved] (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as benzene, 1,1′-methylenebis[4- paragraph. isocyanato-, polymer with (1) Recordkeeping. Recordkeeping re- benzenedicarboxylic acid, butyl dialkyl quirements as specified in § 721.125 (a), ester, poly[oxy(methyl-1,2-ethanediyl)], (b), (c), and (i) are applicable to manu- .alpha.-hydro-.omega.-hydroxy-, facturers, importers, and processors of oxirane, alkyl-, polymer with oxirane, this substance. ether with propanepolyol and (2) Limitations or revocation of certain Sartomer’s HLBH P-3000 and Lexorez notification requirements. The provisions 1180 (PMN P–05–380) is subject to re- of § 721.185 apply to this section. porting under this section for the significant new uses described in para- [72 FR 53483, Sept. 19, 2007] graph (a)(2) of this section. (2) The significant new uses are: § 721.10071 9H-Thioxanthenium, 10- [1,1′-biphenyl]-4-yl-2-(1- (i) Industrial, commercial, and con- methylethyl)-9-oxo-, sumer activities. Requirements as speci- hexafluorophosphate (1-) (1:1). fied in § 721.80(y)(1). (ii) [Reserved] (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified as 9H- this section except as modified by this thioxanthenium, 10-[1,1′-biphenyl]-4-yl- paragraph. 2-(1-methylethyl)-9-oxo-, (1) Recordkeeping. Recordkeeping re- hexafluorophosphate (1-) (1:1) (PMN P– quirements as specified in § 721.125 (a), 05–364; CAS No. 591773–92–1) is subject (b), (c), and (i) are applicable to manu- to reporting under this section for the facturers, importers, and processors of significant new uses described in para- this substance. graph (a)(2) of this section. (2) Limitations or revocation of certain (2) The significant new uses are: notification requirements. The provisions (i) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as specified in § 721.80 (f), (v)(2), (w)(2), and [72 FR 53484, Sept. 19, 2007] (x)(2). (ii) [Reserved] § 721.10073 Modified alkyl acrylamide (generic). (b) Specific requirements. The provisions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified generi- (1) Recordkeeping. Recordkeeping re- cally as modified alkyl acrylamide quirements as specified in § 721.125 (a), (PMN P–05–536) is subject to reporting (b), (c), and (i) are applicable to manu- under this section for the significant facturers, importers, and processors of new uses described in paragraph (a)(2) this substance. of this section. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Industrial, commercial, and con- notification requirements. The provisions sumer activities. Requirements as speci- of § 721.185 apply to this section. fied in § 721.80(j). [72 FR 53483, Sept. 19, 2007] (ii) [Reserved]

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(b) Specific requirements. The provi- nificant new uses described in para- sions of subpart A of this part apply to graph (a)(2) of this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Protection in the workplace. Re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.63 (a)(1), quirements as specified in § 721.125 (a), (a)(2)(i), (a)(3), (b) (concentration set at (b), (c), and (i) are applicable to manu- 1 percent), and (c). facturers, importers, and processors of (ii) Industrial, commercial, and con- this substance. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80 (j), (v)(1), (w)(1), and notification requirements. The provisions (x)(1). of § 721.185 apply to this section. (b) Specific requirements. The provi- (3) Determining whether a specific use is sions of subpart A of this part apply to subject to this section. The provisions of this section except as modified by this § 721.1725(b)(1) apply to this section. paragraph. [72 FR 53484, Sept. 19, 2007] (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), § 721.10074 Acetic acid, 2-chloro-, 1- (b), (c), (d), (e) and (i) are applicable to (3,3-dimethylcyclohexyl)ethyl ester. manufacturers, importers, and proc- (a) Chemical substance and significant essors of this substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified as acetic notification requirements. The provisions acid, 2-chloro-, 1-(3,3- of § 721.185 apply to this section. dimethylcyclohexyl)ethyl ester (PMN (3) Determining whether a specific use is P–05–568; CAS No. 477218–59–0) is subject subject to this section. The provisions of to reporting under this section for the § 721.1725(b)(1) apply to this section. significant new uses described in paragraph (a)(2) of this section. [72 FR 53484, Sept. 19, 2007] (2) The significant new uses are: (i) Industrial, commercial, and con- § 721.10076 Substituted sumer activities. Requirements as speci- benzenediamine (generic). fied in § 721.80(h). (a) Chemical substance and significant (ii) [Reserved] new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substance identified generi- sions of subpart A of this part apply to cally as substituted benzenediamine this section except as modified by this (PMN P–05–792) is subject to reporting paragraph. under this section for the significant (1) Recordkeeping. Recordkeeping renew uses described in paragraph (a)(2) quirements as specified in § 721.125 (a), of this section. (b), (c), and (i) are applicable to manu- (2) The significant new uses are: facturers, importers, and processors of (i) Release to water. Requirements as this substance. specified in § 721.90 (a)(4), (b)(4), and (2) Limitations or revocation of certain (c)(4) (N=2). notification requirements. The provisions (ii) [Reserved] of § 721.185 apply to this section. (b) Specific requirements. The provi- [72 FR 53484, Sept. 19, 2007] sions of subpart A of this part apply to this section except as modified by this § 721.10075 Carbon black, 4-[[2- paragraph. (Sulfooxy) ethyl]substituted] (1) Recordkeeping. Recordkeeping re- phenyl- modified, sodium salts (generic). quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (a) Chemical substance and significant facturers, importers, and processors of new uses subject to reporting. (1) The this substance. chemical substance identified generi- (2) Limitations or revocation of certain cally as carbon black, 4-[[2-(Sulfooxy) notification requirements. The provisions ethyl]substituted] phenyl-modified, so- of § 721.185 apply to this section. dium salts (PMN P–05–722) is subject to reporting under this section for the sig- [72 FR 53484, Sept. 19, 2007]

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§ 721.10077 3H-1,2,4-Triazol-3-one, 1,2- § 721.10078 Butanamide, 2-[(2-methoxy- dihydro-. 4-nitrophenyl)azo]-N-(2- methoxyphenyl)-3-oxo-, 4-[(17-sub- (a) Chemical substance and significant stituted-3,6,9,12,15- new uses subject to reporting. (1) The pentaazaheptadec-1- chemical substance identified as 3H- yl)substituted]phenyl derivs., 1,2,4-triazol-3-one, 1,2-dihydro- (PMNs hydrochlorides (generic). P–06–1 and P–06–166; CAS No. 930–33–6) (a) Chemical substance and significant is subject to reporting under this sec- new uses subject to reporting. (1) The tion for the significant new uses de- chemical substance identified generi- scribed in paragraph (a)(2) of this sec- cally as butanamide, 2-[(2-methoxy-4- tion. nitrophenyl)azo]-N-(2-methoxyphenyl)- (2) The significant new uses are: 3-oxo-, 4-[(17-substituted-3,6,9,12,15- (i) Protection in the workplace. Re- pentaazaheptadec-1- quirements as specified in § 721.63 (a)(4), yl)substituted]phenyl derivs., (a)(5), (a)(6), (b), and (c). Respirators hydrochlorides (PMN P–06–4) is subject must provide a National Institute for to reporting under this section for the Occupational Safety and Health significant new uses described in para- (NIOSH) assigned protection factor of graph (a)(2) of this section. at least 10. The following NIOSH-ap- (2) The significant new uses are: proved respirators with an assigned (i) Release to water. Requirements as protection factor (APF) of 10–25 meet specified in § 721.90 (a)(4), (b)(4), and the minimum requirements for (c)(4) (N=10). § 721.63(a)(4): Air-purifying, tight-fit- (ii) [Reserved] ting respirator equipped with N100 (if (b) Specific requirements. The provi- aerosols absent), R100, or P100 filters sions of subpart A of this part apply to (either half- or full-face); powered air- this section except as modified by this purifying respirator equipped with a paragraph. (1) Recordkeeping. Recordkeeping re- loose-fitting hood or helmet and High quirements as specified in § 721.125 (a), Efficiency Particulate Air (HEPA) fil- (b), (c), and (k) are applicable to manu- ters; powered air-purifying respirator facturers, importers, and processors of equipped with a tight-fitting facepiece this substance. (either half- or full-face) and HEPA fil- (2) Limitations or revocation of certain ters; and supplied-air respirator oper- notification requirements. The provisions ated in pressure demand or continuous of § 721.185 apply to this section. flow mode and equipped with a hood or helmet or tight-fitting facepiece (ei- [72 FR 53485, Sept. 19, 2007] ther half- or full-face). § 721.10079 Quino[2,3-b]acridine-7, 14- (ii) Hazard communication program. dione, 5,12-dihydro-2,9-dimethyl-, 4- Requirements as specified in § 721.72 [(17-substituted-3,6,9,12,15- (g)(1)(ix), (g)(2)(iv), (g)(3)(ii), and pentaazaheptadec-1- (g)(4)(iii). yl)substituted]phenyl derivs., (iii) Release to water. Requirements as hydrochlorides (generic). specified in § 721.90 (a)(1), (b)(1), and (a) Chemical substance and significant (c)(1). new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substance identified generi- sions of subpart A of this part apply to cally as quino[2,3-b]acridine-7, 14-dione, this section except as modified by this 5,12-dihydro-2,9-dimethyl-, 4-[(17-subparagraph. stituted-3,6,9,12,15-pentaazaheptadec-1- (1) Recordkeeping. Recordkeeping re- yl)substituted]phenyl derivs., quirements as specified in § 721.125 (a), hydrochlorides (PMN P–06–7) is subject (b), (c), (d), (f), (g), (h), and (k) are ap- to reporting under this section for the plicable to manufacturers, importers, significant new uses described in para- and processors of this substance. graph (a)(2) of this section. (2) Limitations or revocation of certain (2) The significant new uses are: notification requirements. The provisions (i) Protection in the workplace. Re- quirements as specified in § 721.63 (a)(1), of § 721.185 apply to this section. (a)(2)(i), (a)(3), (b) (concentration set at [72 FR 53485, Sept. 19, 2007] 1 percent), and (c).

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(ii) Industrial, commercial, and con- ble to manufacturers, importers, and sumer activities. Requirements as speci- processors of this substance. fied in § 721.80 (j), (v)(1), (w)(1), and (2) Limitations or revocation of certain (x)(1). notification requirements. The provisions (iii) Release to water. Requirements as of § 721.185 apply to this section. specified in § 721.90 (a)(4), (b)(4), and (3) Determining whether a specific use is (c)(4) (N=10). subject to this section. The provisions of (b) Specific requirements. The provi- § 721.1725(b)(1) apply to this section. sions of subpart A of this part apply to [72 FR 53485, Sept. 19, 2007] this section except as modified by this paragraph. § 721.10081 Aromatic urethane acry- (1) Recordkeeping. Recordkeeping relate oligomer (generic). quirements as specified in § 721.125 (a), (a) Chemical substance and significant (b), (c), (d), (e), (i), and (k) are applica- new uses subject to reporting. (1) The ble to manufacturers, importers, and chemical substance identified generi- processors of this substance. cally as aromatic urethane acrylate (2) Limitations or revocation of certain oligomer (PMN P–06–26) is subject to notification requirements. The provisions reporting under this section for the sig- of § 721.185 apply to this section. nificant new uses described in para- (3) Determining whether a specific use is graph (a)(2) of this section. subject to this section. The provisions of (2) The significant new uses are: § 721.1725(b)(1) apply to this section. (i) Release to water. Requirements as [72 FR 53485, Sept. 19, 2007] specified in § 721.90 (a)(1), (b)(1), and (c)(1). § 721.10080 Carbon black, 4-[(17-sub- (ii) [Reserved] stituted-3,6,9,12,15- (b) Specific requirements. The provi- pentaazaheptadec-1-yl) substituted] sions of subpart A of this part apply to phenyl-modified, hydrochlorides this section except as modified by this (generic). paragraph. (a) Chemical substance and significant (1) Recordkeeping. Recordkeeping renew uses subject to reporting. (1) The quirements as specified in § 721.125 (a), chemical substance identified generi- (b), (c), and (k) are applicable to manu- cally as carbon black, 4-[(17-sub- facturers, importers, and processors of stituted-3,6,9,12,15-pentaazaheptadec-1- this substance. yl) substituted] phenyl-modified, (2) Limitations or revocation of certain hydrochlorides (PMN P–06–8) is subject notification requirements. The provisions to reporting under this section for the of § 721.185 apply to this section. significant new uses described in para- [72 FR 53485, Sept. 19, 2007] graph (a)(2) of this section. (2) The significant new uses are: § 721.10082 Amine modified monomer (i) Protection in the workplace. Re- acrylate (generic). quirements as specified in § 721.63 (a)(1), (a) Chemical substance and significant (a)(2)(i), (a)(3), (b) (concentration set at new uses subject to reporting. (1) The 1 percent), and (c). chemical substance identified generi- (ii) Industrial, commercial, and con- cally as amine modified monomer acry- sumer activities. Requirements as speci- late (PMN P–06–29) is subject to report- fied in § 721.80 (j), (v)(1), (w)(1), and ing under this section for the signifi- (x)(1). cant new uses described in paragraph (iii) Release to water. Requirements as (a)(2) of this section. specified in § 721.90 (a)(4), (b)(4), and (2) The significant new uses are: (c)(4) (N=10). (i) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(1), (b)(1), and sions of subpart A of this part apply to (c)(1). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), (d), (e), (i), and (k) are applica- paragraph.

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(1) Recordkeeping. Recordkeeping re- § 721.10084 Modified thionocarbamate quirements as specified in § 721.125 (a), (generic). (b), (c), and (k) are applicable to manu- (a) Chemical substance and significant facturers, importers, and processors of new uses subject to reporting. (1) The this substance. chemical substance identified generi- (2) Limitations or revocation of certain cally as modified thionocarbamate notification requirements. The provisions (PMN P–06–124 is subject to reporting of § 721.185 apply to this section. under this section for the significant new uses described in paragraph (a)(2) [72 FR 53486, Sept. 19, 2007] of this section. § 721.10083 Copper, [29H, 31H- (2) The significant new uses are: phthalocyaninato (2-)-N29, N30, (i) Release to water. Requirements as N31, N32]-, 4-[(17-substituted- specified in § 721.90 (a)(1), (b)(1), and 3,6,9,12,15- pentaazaheptadec-1-yl) (c)(1). substituted] phenyl derivs., (ii) [Reserved] hydrochlorides (generic). (b) Specific requirements. The provi- (a) Chemical substance and significant sions of subpart A of this part apply to new uses subject to reporting. (1) The this section except as modified by this chemical substance identified generi- paragraph. cally as copper, [29H, 31H- (1) Recordkeeping. Recordkeeping re- phthalocyaninato (2-)-N29, N30, N31, quirements as specified in § 721.125 (a), N32]-, 4-[(17-substituted-3,6,9,12,15- (b), (c), and (k) are applicable to manu- pentaazaheptadec-1-yl) substituted] facturers, importers, and processors of phenyl derivs., hydrochlorides (PMN P– this substance. 06–70) is subject to reporting under this (2) Limitations or revocation of certain section for the significant new uses de- notification requirements. The provisions scribed in paragraph (a)(2) of this sec- of § 721.185 apply to this section. tion. [72 FR 53486, Sept. 19, 2007] (2) The significant new uses are: (i) Protection in the workplace. Re- § 721.10085 Substituted polyaryl sul- quirements as specified in § 721.63 (a)(1), fonium polyhalide phosphate salt (a)(2)(i), (a)(3), (b) (concentration set at (generic). 1 percent), and (c). (a) Chemical substance and significant (ii) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified generi- fied in § 721.80 (j), (v)(1), (w)(1), and cally as substituted polyaryl sulfonium (x)(1). polyhalide phosphate salt (PMN P–06– (iii) Release to water. Requirements as 232) is subject to reporting under this specified in § 721.90 (a)(4), (b)(4), and section for the significant new uses de- (c)(4) (N=10). scribed in paragraph (a)(2) of this sec- (b) Specific requirements. The provi- tion. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Industrial, commercial, and con- paragraph. sumer activities. Requirements as speci- (1) Recordkeeping. Recordkeeping re- fied in § 721.80 (f) and (j) (photo quirements as specified in § 721.125 (a), initiator used in photo-curable com- (b), (c), (d), (e), (i), and (k) are applica- positions). ble to manufacturers, importers, and (ii) [Reserved] processors of this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. (3) Determining whether a specific use is (1) Recordkeeping. Recordkeeping re- subject to this section. The provisions of quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- § 721.1725(b)(1) apply to this section. facturers, importers, and processors of [72 FR 53486, Sept. 19, 2007] this substance.

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(2) Limitations or revocation of certain (b), (c), and (i) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this substance. (2) Limitations or revocation of certain [72 FR 53486, Sept. 19, 2007] notification requirements. The provisions § 721.10086 Ethane, 2- of § 721.185 apply to this section. (difluoromethoxy)-1,1,1-trifluoro-. [72 FR 53487, Sept. 19, 2007] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.10088 Thiophene, 2,5-dibromo-3- chemical substance identified as eth- hexyl-. ane, 2-(difluoromethoxy)-1,1,1-trifluoro- (a) Chemical substance and significant (PMN P–06–295; CAS No. 1885–48–9) is new uses subject to reporting. (1) The subject to reporting under this section chemical substance identified as for the significant new uses described thiophene, 2,5-dibromo-3-hexyl- (PMN in paragraph (a)(2) of this section. P–07–283; CAS No. 116971–11–0) is subject (2) The significant new uses are: to reporting under this section for the (i) Protection in the workplace. Re- significant new uses described in para- quirements as specified in § 721.63 (a)(1), graph (a)(2) of this section. (a)(2)(i), (a)(3), (b), and (c). (2) The significant new uses are: (ii) Industrial, commercial, and con- (i) Industrial, commercial, and consumer activities. Requirements as speci- sumer activities. Requirements as specified in § 721.80(g). fied in § 721.80(s) (4,500 kilograms). (b) Specific requirements. The provi- (ii) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(4), (b)(4), and this section except as modified by this (c)(4) (N=1). paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), (d), (e) and (i) are applicable to paragraph. manufacturers, importers, and proc- (1) Recordkeeping. Recordkeeping re- essors of this substance. quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), (i), and (k) are applicable to notification requirements. The provisions manufacturers, importers, and proc- of § 721.185 apply to this section. essors of this substance. (2) Limitations or revocation of certain [72 FR 53486, Sept. 19, 2007] notification requirements. The provisions § 721.10087 Substituted alkyl of § 721.185 apply to this section. phosphine oxide (generic). [74 FR 32465, July 8, 2009] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.10089 Modified salicylic acid, zir- chemical substance identified generi- conium complex (generic). cally as substituted alkyl phosphine (a) Chemical substance and significant oxide (PMN P–06–332) is subject to renew uses subject to reporting. (1) The porting under this section for the sig- chemical substance identified generi- nificant new uses described in para- cally as modified salicylic acid, zir- graph (a)(2) of this section. conium complex (PMN P–00–552) is sub- (2) The significant new uses are: ject to reporting under this section for (i) Industrial, commercial, and con- the significant new uses described in sumer activities. Requirements as speci- paragraph (a)(2) of this section. fied in § 721.80(s) (100,000 kilograms/ (2) The significant new uses are: year). (i) Release to water. Requirements as (ii) [Reserved] specified in § 721.90 (a)(1), (b)(1), and (b) Specific requirements. The provi- (c)(1). sions of subpart A of this part apply to (ii) [Reserved] this section except as modified by this (b) Specific requirements. The provi- paragraph. sions of subpart A of this part apply to (1) Recordkeeping. Recordkeeping re- this section except as modified by this quirements as specified in § 721.125 (a), paragraph.

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(1) Recordkeeping. Recordkeeping re- § 721.10091 2(1H)-Pyrimidinone, quirements as specified in § 721.125 (a), tetrahydro-1,3-dimethyl-. (b), (c), and (k) are applicable to manu- (a) Chemical substance and significant facturers, importers, and processors of new uses subject to reporting. (1) The this substance. chemical substance identified as 2(1H)- (2) Limitations or revocation of certain pyrimidinone, tetrahydro-1,3-dimethyl- notification requirements. The provisions (PMN P–02–135; CAS No. 7226–23–5) is of § 721.185 apply to this section. subject to reporting under this section [73 FR 65758, Nov. 5, 2008] for the significant new uses described in paragraph (a)(2) of this section. § 721.10090 Tertiary amine salt of gly- (2) The significant new uses are: col succinate (generic). (i) Protection in the workplace. Re- (a) Chemical substance and significant quirements as specified in § 721.63 (a)(1), new uses subject to reporting. (1) The (a)(2)(i), (a)(3)(i), (b), and (c). Best’s chemical substance identified generi- Viton model #890, Best’s Butyl model cally as tertiary amine salt of glycol #874, and Best’s Butyl #878 have been succinate (PMN P–01–595) is subject to demonstrated to satisfy § 721.63(a)(3)(i). reporting under this section for the sig- Other demonstrated impervious gloves nificant new uses described in para- that satisfy § 721.63(a)(3)(i) are permis- graph (a)(2) of this section. sible. (2) The significant new uses are: (ii) Industrial, commercial, and con- (i) Industrial, commercial, and consumer activities. Requirements as speci- sumer activities. Requirements as specified in § 721.80 (f), (j) (aprotic solvent fied in § 721.80(k). and catalyst), and (s) (20,000 kg). (A) Restricting the manufacture of (b) Specific requirements. The provi- the PMN substance with only those sions of subpart A of this part apply to feedstocks specified in the PMN sub- this section except as modified by this mission. paragraph. (B) Manufacture, import, or proc- (1) Recordkeeping. Recordkeeping re- essing of the PMN substance without quirements as specified in § 721.125 (a), analyzing representative samples of (b), (c), (d), (e), and (i) are applicable to the chemical substance to determine manufacturers, importers, and proc- compliance with the requirements in essors of this substance. § 721.10090(a)(2)(i)(A). To ensure compli- (2) Limitations or revocation of certain ance, the PMN substance must be ana- notification requirements. The provisions lyzed (1) at the time of initial com- of § 721.185 apply to this section. mencement of non-exempt commercial (3) Determining whether a specific use is manufacture of the chemical sub- subject to this section. The provisions of stance, and (2) at least annually there- § 721.1725(b)(1) apply to this section. after during every year in which the substance is manufactured. [73 FR 65758, Nov. 5, 2008] (ii) [Reserved] (b) Specific requirements. The provi- § 721.10092 Poly(oxy-1,2-ethanediyl), sions of subpart A of this part apply to .alpha.-sulfo-.omega.-[[1-[(2-propen- this section except as modified by this 1-yloxy)methyl]undecyl]oxy]-, ammonium salt (1:1); Poly(oxy-1,2- paragraph. ethanediyl), .alpha.-sulfo-.omega.- (1) Recordkeeping. Recordkeeping re- [[1-[(2-propen-1- quirements as specified in § 721.125 (a), yloxy)methyl]tridecyl]oxy]-, ammo- (b), (c), and (i) are applicable to manu- nium salt (1:1). facturers, importers, and processors of (a) Chemical substance and significant this substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified as notification requirements. The provisions poly(oxy-1,2-ethanediyl), .alpha.-sulfo- of § 721.185 apply to this section. .omega.-[[1-[(2-propen-1- (3) Determining whether a specific use is yloxy)methyl]undecyl]oxy]-, ammo- subject to this section. The provisions of nium salt (1:1); poly(oxy-1,2- § 721.1725(b)(1) apply to this section. ethanediyl), .alpha.-sulfo-.omega.-[[1- [73 FR 65758, Nov. 5, 2008] [(2-propen-1-

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yloxy)methyl]tridecyl]oxy]-, ammo- (2) Limitations or revocation of certain nium salt (1:1) (PMN P–02–421; CAS notification requirements. The provisions Nos. 352661–91–7 and 224646–44–0) is sub- of § 721.185 apply to this section. ject to reporting under this section for [73 FR 65759, Nov. 5, 2008] the significant new uses described in paragraph (a)(2) of this section. § 721.10094 Decene, branched and lin- (2) The significant new uses are: ear. (i) Industrial, commercial, and consumer activities. Requirements as speci- (a) Chemical substance and significant fied in § 721.80(k) (no manufacture or new uses subject to reporting. (1) The import of the PMN substance unless: chemical substance identified as dec- (1) The mean number of moles of the ene, branched and linear (PMN P–03– ethoxy group is equal to or greater 272; CAS No. 833482–31–8) is subject to than 8 or (2) the average molecular reporting under this section for the sig- weight is greater than 721 daltons). nificant new uses described in para- Representative samples of the PMN graph (a)(2) of this section. substance must be analyzed and deter- (2) The significant new uses are: mined to comply with these require- (i) Release to water. Requirements as ments both at the time of initial com- specified in § 721.90 (a)(1), (b)(1), and mencement and annually thereafter. (c)(1). (ii) [Reserved] (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Record keeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- (b), (c), and (k) are applicable to manufacturers, importers, and processors of facturers, importers, and processors of this substance. this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [73 FR 65758, Nov. 5, 2008] [73 FR 65759, Nov. 5, 2008]

§ 721.10093 Alkylamides, ethoxylated § 721.10095 Oxetane, 3,3′- (generic). [oxybis(methylene)] bis[3-ethyl-. (a) Chemical substance and significant (a) Chemical substance and significant new uses subject to reporting. (1) The new uses subject to reporting. (1) The chemical substances identified generi- chemical substance identified as cally as alkylamides, ethoxylated oxetane, 3,3′-[oxybis(methylene)] bis[3- (PMNs P–03–12 and P–03–13) are subject ethyl- (PMN P–03–471; CAS No. 18934– to reporting under this section for the 00–4) is subject to reporting under this significant new uses described in para- section for the significant new uses de- graph (a)(2) of this section. scribed in paragraph (a)(2) of this sec- (2) The significant new uses are: tion. (i) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(1), (b)(1), and (i) Protection in the workplace. Re- (c)(1). quirements as specified in § 721.63 (a)(1), (ii) [Reserved] (a)(2)(i), (a)(2)(iii), and (a)(3) (polyvinyl (b) Specific requirements. The provi- alcohol gloves with a thickness of no sions of subpart A of this part apply to less than 31.3 mils or silvershield/4H this section except as modified by this sleeves with a thickness of no less than paragraph. 2.7 mils have satisfied § 721.63(a)(3)(i) (1) Recordkeeping. Recordkeeping re- for up to 8 hours. quirements as specified in § 721.125 (a), (ii) Hazard communication program. (b), (c), and (k) are applicable to manu- Requirements as specified in § 721.72 (a), facturers, importers, and processors of (b), (c), (d), (e), (f), (g)(1)(iv), (g)(1)(vi), these substances. and (g)(2)(v).

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(iii) Industrial, commercial, and con- cally as disubstituted benzenesulfonic sumer activities. Requirements as speci- acid, alkali metal salt (PMN P–03–642) fied in § 721.80(q). is subject to reporting under this sec- (b) Specific requirements. The provi- tion for the significant new uses de- sions of subpart A of this part apply to scribed in paragraph (a)(2) of this sec- this section except as modified by this tion. paragraph. (2) The significant new uses are: (1) Recordkeeping. Recordkeeping re- (i) Industrial, commercial, and con- quirements as specified in § 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are sumer activities. Requirements as speci- applicable to manufacturers, import- fied in § 721.80(j). ers, and processors of this substance. (ii) [Reserved] (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this (3) Determining whether a specific use is paragraph. subject to this section. The provisions of (1) Recordkeeping. Recordkeeping re- § 721.1725(b)(1) apply to this section. quirements as specified in § 721.125 (a), [73 FR 65759, Nov. 5, 2008, as amended at 74 (b), (c), and (i) are applicable to manu- FR 57425, Nov. 6, 2009] facturers, importers, and processors of this substance. § 721.10096 Benzene, 1,4-bis (2) Limitations or revocation of certain (methoxymethyl)-. notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The (3) Determining whether a specific use is chemical substance identified as ben- subject to this section. The provisions of zene, 1,4-bis (methoxymethyl)- (PMN § 721.1725(b)(1) apply to this section. P–03–614; CAS No. 6770–38–3) is subject to reporting under this section for the [73 FR 65759, Nov. 5, 2008] significant new uses described in paragraph (a)(2) of this section. § 721.10098 Disubstituted benzoic acid, (2) The significant new uses are: alkali metal salt (generic). (i) Industrial, commercial, and con- (a) Chemical substance and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80(q). chemical substance identified generi- (ii) [Reserved] cally as disubstituted benzoic acid, al- (b) Specific requirements. The provi- kali metal salt (PMN P–03–643) is sub- sions of subpart A of this part apply to this section except as modified by this ject to reporting under this section for paragraph. the significant new uses described in (1) Recordkeeping. Recordkeeping re- paragraph (a)(2) of this section. quirements as specified in § 721.125 (a), (2) The significant new uses are: (b), (c), and (i) are applicable to manu- (i) Industrial, commercial, and con- facturers, importers, and processors of sumer activities. Requirements as speci- this substance. fied in § 721.80(j). (2) Limitations or revocation of certain (ii) [Reserved] notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to (3) Determining whether a specific use is this section except as modified by this subject to this section. The provisions of paragraph. § 721.1725(b)(1) apply to this section. (1) Recordkeeping. Recordkeeping re- [73 FR 65759, Nov. 5, 2008] quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- § 721.10097 Disubstituted facturers, importers, and processors of benzenesulfonic acid, alkali metal salt (generic). this substance. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generi-

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§ 721.10099 Dialkyl dimethyl ammo- § 721.10101 Copolymer of alkyl acry- nium carbonate (generic). late and ethyleneglycol (a) Chemical substance and significant dimethacrylate (generic). new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as dialkyl dimethyl ammonium chemical substance identified generi- carbonate (1:1) (PMN P–03–715) is sub- cally as copolymer of alkyl acrylate ject to reporting under this section for and ethyleneglycol dimethacrylate the significant new uses described in (PMN P–03–755) is subject to reporting paragraph (a)(2) of this section. under this section for the significant (2) The significant new uses are: new uses described in paragraph (a)(2) (i) Release to water. Requirements as of this section. specified in § 721.90 (a)(4), (b)(4), and (2) The significant new uses are: (c)(4) (N = 5). (i) Protection in the workplace. Re- (ii) [Reserved] quirements as specified in § 721.63 (a)(4), (b) Specific requirements. The provi- (a)(5), (a)(6)(i), (a)(6)(ii), (b), and (c). sions of subpart A of this part apply to The following National Institute for this section except as modified by this Occupational Safety and Health paragraph. (NIOSH)-approved respirators with an (1) . Recordkeeping re- Recordkeeping assigned protection factor (APF) of 10- quirements as specified in § 721.125 (a), 25 meet the minimum requirements for (b), (c), and (k) are applicable to manu- § 721.63(a)(4): Air-purifying, tight-fit- facturers, importers, and processors of ting respirator equipped with N100 (if this substance. oil aerosols absent), R100, or P100 fil- (2) Limitations or revocation of certain ters (either half- or full-face); powered notification requirements. The provisions air-purifying respirator equipped with of § 721.185 apply to this section. a loose-fitting hood or helmet and High [73 FR 65760, Nov. 5, 2008] Efficiency Particulate Air (HEPA) filters; powered air-purifying respirator § 721.10100 Dialkyl dimethyl ammo- equipped with a tight-fitting facepiece nium carbonate (2:1) (generic). (either half- or full-face) and HEPA fil- (a) Chemical substance and significant ters; and supplied-air respirator oper- new uses subject to reporting. (1) The ated in pressure demand or continuous chemical substance identified generi- flow mode and equipped with a hood or cally as dialkyl dimethyl ammonium helmet, or tight-fitting facepiece (ei- carbonate (2:1) (PMN P–03–716) is sub- ther half- or full-face). ject to reporting under this section for (ii) Industrial, commercial, and con- the significant new uses described in sumer activities. Requirements as speci- paragraph (a)(2) of this section. fied in § 721.80(f). (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(4), (b)(4), and this section except as modified by this (c)(4) (N = 5). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), (d), and (i) are applicable to this section except as modified by this manufacturers, importers, and proc- paragraph. essors of this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of this substance. [73 FR 65760, Nov. 5, 2008]

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§ 721.10102 Diphosphoric acid, compd. (2) Limitations or revocation of certain with piperazine (1:1). notification requirements. The provisions of § 721.185 apply to this section. (a) Chemical substance and significant new uses subject to reporting. (1) The [73 FR 65760, Nov. 5, 2008] chemical substance identified as diphosphoric acid, compd. with piper- § 721.10104 Halophosphate mixed azine (1:1) (PMN P–04–126; CAS No. metal complex (generic). 66034–17–1) is subject to reporting under (a) Chemical substance and significant this section for the significant new new uses subject to reporting. (1) The uses described in paragraph (a)(2) of chemical substance identified generi- this section. cally as halophosphate mixed metal (2) The significant new uses are: complex (PMN P–04–254) is subject to (i) Industrial, commercial, and con- reporting under this section for the sig- sumer activities. Requirements as speci- nificant new uses described in para- fied in § 721.80(j) (flame retardant). graph (a)(2) of this section. (2) The significant new uses are: (ii) [Reserved] (i) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(4), (b)(4), and sions of subpart A of this part apply to (c)(4) (N=10). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), and (i) are applicable to manu- paragraph. facturers, importers, and processors of (1) Recordkeeping. Recordkeeping re- this substance. quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), and (k) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this substance. (2) Limitations or revocation of certain [73 FR 65760, Nov. 5, 2008] notification requirements. The provisions § 721.10103 Naphtha (Fischer-Tropsch), of § 721.185 apply to this section. C4-11-alkane, branched and linear. [73 FR 65761, Nov. 5, 2008] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.10105 Polyfluoroalkylether (generic). chemical substance identified as naphtha (fischer-tropsch), C4-11-alkane, (a) Chemical substance and significant branched and linear (PMN P–04–235; new uses subject to reporting. (1) The CAS No. 849101–58–2) is subject to re- chemical substance identified generi- porting under this section for the sig- cally as polyfluoroalkylether (PMN P– nificant new uses described in para- 04–417) is subject to reporting under graph (a)(2) of this section. this section for the significant new (2) The significant new uses are: uses described in paragraph (a)(2) of this section. (i) Disposal. Requirements as speci- (2) The significant new uses are: fied in § 721.85 (a)(1), (b)(1) and (c)(1). (i) Industrial, commercial, and con- (ii) Release to water. Requirements as sumer activities. Requirements as speci- specified in § 721.90 (a)(1), (b)(1), and fied in § 721.80(y)(1). (c)(1). (ii) [Reserved] (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), (j), and (k) are applicable to (b), (c), and (i) are applicable to manu- manufacturers, importers, and proc- facturers, importers, and processors of essors of this substance. this substance.

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(2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this [73 FR 65761, Nov. 5, 2008] paragraph. (1) Recordkeeping. Recordkeeping re- § 721.10106 Silica, quirements as specified in § 721.125 (a), [(ethenylsilylidyne)tris(oxy)] - modi- (b), (c), and (i) are applicable to manu- fied. facturers, importers, and processors of (a) Chemical substance and significant this substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified as silica notification requirements. The provisions , [(ethenylsilylidyne)tris(oxy)] - modi- of § 721.185 apply to this section. fied (PMN P–04–419; CAS No. 649574–37– (3) Determining whether a specific use is 8) is subject to reporting under this subject to this section. The provisions of section for the significant new uses de- § 721.1725(b)(1) apply to this section. scribed in paragraph (a)(2) of this section. [73 FR 65761, Nov. 5, 2008] (2) The significant new uses are: (i) Industrial, commercial, and con- § 721.10108 Naphthalenedisulfonic sumer activities. Requirements as speci- acid, hydrozy-[[[(hydroxyl-disulfo- naphthaleneyl)azo]-alkyl(C=1-5)- fied in § 721.80 (v)(1), (w)(1), and (x)(1). (sulfoalkoxy)cyclic]azo]-substituted (ii) [Reserved] azo-, metal salt (generic). (b) Specific requirements. The provisions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified generi- (1) Recordkeeping. Recordkeeping re- cally as naphthalenedisulfonic acid, quirements as specified in § 721.125 (a), hydrozy-[[[(hydroxyl-disulfo- (b), (c), and (i) are applicable to manu- naphthaleneyl)azo]-alkyl(C=1-5)- facturers, importers, and processors of (sulfoalkoxy)cyclic]azo]-substituted this substance. azo-, metal salt (PMN P–04–498) is sub- (2) Limitations or revocation of certain ject to reporting under this section for notification requirements. The provisions the significant new uses described in of § 721.185 apply to this section. paragraph (a)(2) of this section. [73 FR 65761, Nov. 5, 2008] (2) The significant new uses are: (i) Industrial, commercial, and con- § 721.10107 Naphthalenedisulfonic sumer activities. Requirements as speci- acid, [amino-hydroxy-[(sub- fied in § 721.80 (f) and (j). stituted)azo-sulfo- (ii) [Reserved] naphthaleneyl]azo]-hydroxy- (b) Specific requirements. The provi- [(methoxy-sulfophenyl)azo], metal salt (generic). sions of subpart A of this part apply to this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The chemical substance identified generi- (1) Recordkeeping. Recordkeeping re- cally as naphthalenedisulfonic acid, quirements as specified in § 721.125 (a), [amino-hydroxy-[(substituted)azo- (b), (c), and (i) are applicable to manu- sulfo-naphthaleneyl]azo]-hydroxy- facturers, importers, and processors of [(methoxy-sulfophenyl)azo], metal salt this substance. (PMN P–04–495) is subject to reporting (2) Limitations or revocation of certain under this section for the significant notification requirements. The provisions new uses described in paragraph (a)(2) of § 721.185 apply to this section. of this section. (3) Determining whether a specific use is (2) The significant new uses are: subject to this section. The provisions of (i) Industrial, commercial, and con- § 721.1725(b)(1) apply to this section. sumer activities. Requirements as specified in § 721.80 (f) and (j). [73 FR 65761, Nov. 5, 2008] (ii) [Reserved]

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§ 721.10109 Hexanoic acid, 2-ethyl-, manufacturers, importers, and proc- mixed triesters with benzoic acid essors of this substance. and trimethylolpropane. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified as [73 FR 65762, Nov. 5, 2008] hexanoic acid, 2-ethyl-, mixed triesters with benzoic acid and § 721.10111 Hexanoic acid, 2-ethyl-, trimethylolpropane (PMN P–04–508; mixed diesters with benzoic acid CAS No. 610787–76–3 ) is subject to re- and diethylene glycol. porting under this section for the sig- (a) Chemical substance and significant nificant new uses described in para- new uses subject to reporting. (1) The graph (a)(2) of this section. chemical substance identified as (2) The significant new uses are: hexanoic acid, 2-ethyl-, mixed diesters (i) Industrial, commercial, and con- with benzoic acid and diethylene glycol sumer activities. Requirements as speci- (PMN P–04–510; CAS No. 610787–78–5) is fied in § 721.80(f). subject to reporting under this section (ii) Release to water. Requirements as for the significant new uses described specified in § 721.90 (b)(1) and (c)(1). in paragraph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80(f). (1) Recordkeeping. Record keeping re- (ii) Release to water. Requirements as quirements as specified in § 721.125 (a), specified in § 721.90 (b)(1) and (c)(1). (b) . The provi- (b), (c), (i), and (k) are applicable to Specific requirements sions of subpart A of this part apply to manufacturers, importers, and proc- this section except as modified by this essors of this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), (i), and (k) are applicable to [73 FR 65761, Nov. 5, 2008] manufacturers, importers, and processors of this substance. § 721.10110 Hexanoic acid, 2-ethyl-, (2) Limitations or revocation of certain mixed diesters with benzoic acid notification requirements. The provisions and neopentlyl glycol. of § 721.185 apply to this section. (a) Chemical substance and significant [73 FR 65762, Nov. 5, 2008] new uses subject to reporting. (1) The chemical substance identified as § 721.10112 Ethanone, 2-chloro-1-(1- hexanoic acid, 2-ethyl-, mixed diesters chlorocyclopropyl)-. with benzoic acid and neopentlyl glycol (a) Chemical substance and significant (PMN P–04–509; CAS No. 610787–77–4) is new uses subject to reporting. (1) The subject to reporting under this section chemical substance identified as for the significant new uses described ethanone, 2-chloro-1-(1- in paragraph (a)(2) of this section. chlorocyclopropyl)- (PMN P–04–530; (2) The significant new uses are: CAS No. 120983–72–4) is subject to re- (i) Industrial, commercial, and con- porting under this section for the sig- sumer activities. Requirements as speci- nificant new uses described in para- fied in § 721.80(f). graph (a)(2) of this section. (ii) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (b)(1) and (c)(1). (i) Industrial, commercial, and con- (b) Specific requirements. The provi- sumer activities. Requirements as speci- sions of subpart A of this part apply to fied in § 721.80(g). this section except as modified by this (ii) Release to water. Requirements as paragraph. specified in § 721.90 (a)(1), (b)(1), and (1) Recordkeeping. Recordkeeping re- (c)(1). quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), (i), and (k) are applicable to sions of subpart A of this part apply to

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this section except as modified by this (i) Release to water. Requirements as paragraph. specified in § 721.90 (a)(1), (b)(1), and (1) Recordkeeping. Recordkeeping re- (c)(1). quirements as specified in § 721.125 (a), (ii) [Reserved] (b), (c), (i), and (k) are applicable to (b) Specific requirements. The provi- manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- [73 FR 65762, Nov. 5, 2008] facturers, importers, and processors of those substances. § 721.10113 Thioether epoxy (generic). (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generi- [73 FR 65762, Nov. 5, 2008] cally as thioether epoxy (PMN P–04– 547) is subject to reporting under this § 721.10115 1-Hexadecanaminium, N,N- section for the significant new uses de- dibutyl-N-(2-hydroxyethyl)-, bro- scribed in paragraph (a)(2) of this sec- mide (1:1). tion. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Industrial, commercial, and con- chemical substance identified as 1- sumer activities. Requirements as speci- hexadecanaminium, N,N-dibutyl-N-(2- fied in § 721.80(j). hydroxyethyl)-, bromide (1:1) (PMN P– (ii) Release to water. Requirements as 04–625; CAS No. 160653–08–7) is subject specified in § 721.90 (a)(1), (b)(1), and to reporting under this section for the (c)(1). significant new uses described in para- (b) Specific requirements. The provi- graph (a)(2) of this section. sions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Release to water. Requirements as paragraph. specified in § 721.90 (a)(1), (b)(1), and (1) Recordkeeping. Recordkeeping re- (c)(1). quirements as specified in § 721.125 (a), (ii) [Reserved] (b), (c), (i), and (k) are applicable to (b) Specific requirements. The provi- manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance. this section except as modified by this paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (k) are applicable to manu- (3) Determining whether a specific use is facturers, importers, and processors of subject to this section. The provisions of this substance. § 721.1725(b)(1) apply to this section. (2) Limitations or revocation of certain [73 FR 65762, Nov. 5, 2008] notification requirements. The provisions of § 721.185 apply to this section. § 721.10114 Polyhydroxyaminoether [73 FR 65762, Nov. 5, 2008] salts (generic). (a) Chemical substance and significant § 721.10116 Blocked polymeric new uses subject to reporting. (1) The isocyanate (generic). chemical substances identified generi- (a) Chemical substance and significant cally as polyhydroxyaminoether salts new uses subject to reporting. (1) The (PMNs P–04–578, P–04–579, P–04–580, P– chemical substance identified generi- 04–581, P–04–582, and-P–04–583) are sub- cally as blocked polymeric isocyanate ject to reporting under this section for (PMN P–04–758) is subject to reporting the significant new uses described in under this section for the significant paragraph (a)(2) of this section. new uses described in paragraph (a)(2) (2) The significant new uses are: of this section.

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(2) The significant new uses are: (PMN P–05–35) is subject to reporting (i) Industrial, commercial, and con- under this section for the significant sumer activities. Requirements as speci- new uses described in paragraph (a)(2) fied in § 721.80(j). of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(1), (b)(1), and this section except as modified by this (c)(1). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), and (i) are applicable to manu- sions of subpart A of this part apply to facturers, importers, and processors of this section except as modified by this this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (k) are applicable to manu- (3) Determining whether a specific use is facturers, importers, and processors of subject to this section. The provisions of this substance. § 721.1725(b)(1) apply to this section. (2) Limitations or revocation of certain [73 FR 65763, Nov. 5, 2008] notification requirements. The provisions of § 721.185 apply to this section. § 721.10117 Heteromonocyclo-beta-(2,4- [73 FR 65763, Nov. 5, 2008] dichlorophenyl) -1-propanol (generic). § 721.10119 Siloxane modified silica (a) Chemical substance and significant nanoparticles (generic). new uses subject to reporting. (1) The chemical substance identified generi- (a) Chemical substance and significant cally as heteromonocyclo-beta-(2,4- new uses subject to reporting. (1) The dichlorophenyl) -1-propanol (PMN P– chemical substance identified generi- 04–776) is subject to reporting under cally as siloxane modified silica nano- this section for the significant new particles (PMN P–05–673) is subject to uses described in paragraph (a)(2) of reporting under this section for the sig- this section. nificant new uses described in para- (2) The significant new uses are: graph (a)(2) of this section. (i) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(1), (b)(1), and (i) Protection in the workplace. Re- (c)(1). quirements as specified in § 721.63 (a)(1), (ii) [Reserved] (a)(2)(i), (a)(3), (a)(4), (a)(5), (a)(6)(ii), (b) (b) Specific requirements. The provi- (concentration set at 1 percent), and sions of subpart A of this part apply to (c). The following National Institute this section except as modified by this for Occupational Safety and Health paragraph. (NIOSH)-approved respirators with an (1) Recordkeeping. Recordkeeping re- APF of 10-25 meet the minimum requirements as specified in § 721.125 (a), quirements for § 721.63(a)(4): Air-puri- (b), (c), and (k) are applicable to manu- fying, tight-fitting respirator equipped facturers, importers, and processors of with N100 (if oil aerosols absent), R100, this substance. or P100 filters (either half- or full-face); (2) Limitations or revocation of certain powered air-purifying respirator notification requirements. The provisions equipped with a loose-fitting hood or of § 721.185 apply to this section. helmet and High Efficiency Particulate [73 FR 65763, Nov. 5, 2008] Air (HEPA) filters; powered air-purifying respirator equipped with a tight- § 721.10118 Substituted aryl acetoni- fitting facepiece (either half- or full- trile (generic). face) and HEPA filters; supplied-air (a) Chemical substance and significant respirator operated in pressure demand new uses subject to reporting. (1) The or continuous flow mode and equipped chemical substance identified generi- with a hood or helmet, or tight-fitting cally as substituted aryl acetonitrile facepiece (either half- or full-face).

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(ii) Industrial, commercial, and con- (b) Specific requirements. The provi- sumer activities. Requirements as speci- sions of subpart A of this part apply to fied in § 721.80 (j), (v)(1), (w)(1), and this section except as modified by this (x)(1). paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Requirements as sions of subpart A of this part apply to specified in § 721.125 (a), (b), (c), (d), (e), this section except as modified by this and (i) are applicable to manufactur- paragraph. ers, importers, and processors of this (1) Recordkeeping. Recordkeeping re- substance. quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), (d), (e), and (i) are applicable to notification requirements. The provisions manufacturers, importers, and proc- of § 721.185 apply to this section. essors of this substance. (3) Determining whether a specific use is (2) Limitations or revocation of certain subject to this section. The provisions of notification requirements. The provisions § 721.1725(b)(1) apply to this section. of § 721.185 apply to this section. (3) Determining whether a specific use is [73 FR 65763, Nov. 5, 2008] subject to this section. The provisions of § 721.1725(b)(1) apply to this section. § 721.10121 Poly[oxy(methyl-1,2- ethanediyl)], .alpha.-methyl-.omega.- [73 FR 65763, Nov. 5, 2008] (4-nonylphenoxy)-, branched. § 721.10120 Siloxane modified alumina (a) Chemical substance and significant nanoparticles (generic). new uses subject to reporting. (1) The chemical substance identified as (a) Chemical substance and significant poly[oxy(methyl-1,2-ethanediyl)], new uses subject to reporting. (1) The chemical substance identified generi- .alpha.-methyl-.omega.-(4- cally as siloxane modified alumina nonylphenoxy)-, branched (PMN P–05– nanoparticles (PMN P–05–687) is subject 766; CAS No. 858944–25–9) is subject to to reporting under this section for the reporting under this section for the sig- significant new uses described in para- nificant new uses described in paragraph (a)(2) of this section. graph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Protection in the workplace. Re- (i) Release to water. Requirements as quirements as specified in § 721.63 (a)(1), specified in § 721.90 (a)(1), (b)(1), and (a)(2)(i), (a)(3), (a)(4), (a)(5), (a)(6)(ii), (b) (c)(1). (concentration set at 1 percent), and (ii) [Reserved] (c). The following National Institute (b) Specific requirements. The provi- for Occupational Safety and Health sions of subpart A of this part apply to (NIOSH)-approved respirators with an this section except as modified by this APF of 10-25 meet the minimum re- paragraph. quirements for § 721.63(a)(4): Air-puri- (1) Recordkeeping. Recordkeeping re- fying, tight-fitting respirator equipped quirements as specified in § 721.125 (a), with N100 (if oil aerosols absent), R100, (b), (c), and (k) are applicable to manu- or P100 filters (either half- or full-face); facturers, importers, and processors of powered air-purifying respirator this substance. equipped with a loose-fitting hood or (2) Limitations or revocation of certain helmet and High Efficiency Particulate notification requirements. The provisions Air (HEPA) filters; powered air-puri- of § 721.185 apply to this section. fying respirator equipped with a tight- [73 FR 65764, Nov. 5, 2008] fitting facepiece (either half- or full- face) and HEPA filters; supplied-air § 721.10122 2-Propenoic acid, 2-methyl- respirator operated in pressure demand , 1,1′-[2-ethyl-2-[[(2-methyl-1-oxo-2- or continuous flow mode and equipped propen-1-yl)oxy]methyl]- 1,3- with a hood or helmet, or tight-fitting propanediyl] ester, polymer with facepiece (either half- or full-face). 1,3-butadiene, ethenylbenzene and (ii) Industrial, commercial, and con- 2-hydroxyethyl 2-methyl-2- sumer activities. Requirements as speci- propenoate. fied in § 721.80 (j), (v)(1), (w)(1), and (a) Chemical substance and significant (x)(1). new uses subject to reporting. (1) The

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chemical substance identified as 2-pro- facturers, importers, and processors of penoic acid, 2-methyl-, 1,1′-[2-ethyl-2- this substance. [[(2-methyl-1-oxo-2-propen-1- (2) Limitations or revocation of certain yl)oxy]methyl]- 1,3-propanediyl] ester, notification requirements. The provisions polymer with 1,3-butadiene, of § 721.185 apply to this section. ethenylbenzene and 2-hydroxyethyl 2- [73 FR 65764, Nov. 5, 2008] methyl-2-propenoate (PMN P–06–151; CAS No. 849925–18–4) is subject to re- § 721.10124 Brominated polyaromatic porting under this section for the sig- compound (generic). nificant new uses described in para- (a) Chemical substance and significant graph (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified generi- (i) Industrial, commercial, and con- cally as brominated polyaromatic com- sumer activities. Requirements as speci- pound (PMN P–06–617) is subject to re- fied in § 721.80(j) (additive in rubber, i.e. porting under this section for the sig- as reinforcing agent; additive in plas- nificant new uses described in para- tics, i.e. as polymeric plasticizer; and graph (a)(2) of this section. additive in polyurethane, i.e. to im- (2) The significant new uses are: prove low temperature flexibility). (i) Protection in the workplace. Imper- (ii) [Reserved] vious gloves: Requirements as specified (b) Specific requirements. The provi- in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b), and sions of subpart A of this part apply to (c). this section except as modified by this (ii) Industrial, commercial, and con- paragraph. sumer activities. Requirements as speci- (1) Recordkeeping. Recordkeeping re- fied in § 721.80(g). quirements as specified in § 721.125 (a), (iii) Release to water. Requirements as (b), (c), and (i) are applicable to manu- specified in § 721.90 (a)(1), (b)(1), and facturers, importers, and processors of (c)(1). these substances. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. (1) Recordkeeping. Recordkeeping re- [73 FR 65764, Nov. 5, 2008] quirements as specified in § 721.125 (a), (b), (c), (d), (e), (i), and (k) are applica- § 721.10123 [1,2,4-Triazolo[1,5- ble to manufacturers, importers, and a]pyrimidin-2-amine, 5,7-dimethoxy- processors of this substance. ]. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified as [1,2,4- triazolo[1,5-a]pyrimidin-2-amine, 5,7- [73 FR 65764, Nov. 5, 2008] dimethoxy-] (PMN P–06–554; CAS No. § 721.10125 Alkenedioic acid, dialkyl 13223–43–3) is subject to reporting under ester, reaction products with this section for the significant new polyaminocarbomonocycle and uses described in paragraph (a)(2) of alkenoic acid alkyl ester (generic). this section. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Release to water. Requirements as chemical substances identified generi- specified in § 721.90 (a)(4), (b)(4), and cally as alkenedioic acid, dialkyl ester, (c)(4) (N = 5). reaction products with (ii) [Reserved] polyaminocarbomonocycle and (b) Specific requirements. The provi- alkenoic acid alkyl ester (PMNs P–06– sions of subpart A of this part apply to 665, P–06–666, P–06–667, P–06–668, P–06– this section except as modified by this 669, and P–06–670) are subject to report- paragraph. ing under this section for the signifi- (1) Recordkeeping. Recordkeeping re- cant new uses described in paragraph quirements as specified in § 721.125 (a), (a)(2) of this section. (b), (c), and (k) are applicable to manu- (2) The significant new uses are:

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(i) Release to water. Requirements as § 721.10127 Alkenyl dimethyl betaine specified in § 721.90 (a)(1), (b)(1), and (generic). (c)(1). (a) Chemical substance and significant (ii) [Reserved] new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substance identified generi- sions of subpart A of this part apply to cally as alkenyl dimethyl betaine this section except as modified by this (PMN P–06–693) is subject to reporting paragraph. under this section for the significant (1) Recordkeeping. Recordkeeping renew uses described in paragraph (a)(2) quirements as specified in § 721.125 (a), of this section. (b), (c), and (k) are applicable to manu- (2) The significant new uses are: facturers, importers, and processors of (i) Industrial, commercial, and con- these substances. sumer activities. Requirements as speci- (2) Limitations or revocation of certain fied in § 721.80(j). notification requirements. The provisions (ii) [Reserved] of § 721.185 apply to this section. (b) Specific requirements. The provi- [73 FR 65764, Nov. 5, 2008] sions of subpart A of this part apply to this section except as modified by this § 721.10126 Alkyl amino substituted paragraph. triazine amino substituted (1) Recordkeeping. Recordkeeping re- benezenesulfonic acid reaction quirements as specified in § 721.125 (a), product with naphthalenesulfonato (b), (c), and (i) are applicable to manu- azo substituted phenyl azo sub- facturers, importers, and processors of stituted benzenesulfonic acid cop- this substance. per compound (generic). (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified generi- (3) Determining whether a specific use is cally as alkyl amino substituted tri- subject to this section. The provisions of azine amino substituted § 721.1725(b)(1) apply to this section. benezenesulfonic acid reaction product with naphthalenesulfonato azo sub- [73 FR 65765, Nov. 5, 2008] stituted phenyl azo substituted § 721.10128 Modified imidazole (ge- benzenesulfonic acid copper compound neric). (PMN P–06–689) is subject to reporting under this section for the significant (a) Chemical substance and significant new uses described in paragraph (a)(2) new uses subject to reporting. (1) The of this section. chemical substance identified generi- (2) The significant new uses are: cally as modified imidazole (PMN P–06– (i) Industrial, commercial, and con- 752) is subject to reporting under this sumer activities. Requirements as speci- section for the significant new uses de- fied in § 721.80(f). scribed in paragraph (a)(2) of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) . Requirements as sions of subpart A of this part apply to Release to water specified in § 721.90 (a)(1), (b)(1), and this section except as modified by this (c)(1). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), and (i) are applicable to manu- sions of subpart A of this part apply to facturers, importers, and processors of this section except as modified by this paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of [73 FR 65764, Nov. 5, 2008] this substance.

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(2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (i) are applicable to manu- [73 FR 65765, Nov. 5, 2008] facturers, importers, and processors of this substance. § 721.10129 Alkylamine ethoxylated (2) Limitations or revocation of certain (generic). notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The (3) Determining whether a specific use is chemical substance identified generi- subject to this section. The provisions of cally as alkylamine ethoxylated (PMN § 721.1725(b)(1) apply to this section. P–07–24) is subject to reporting under [73 FR 65765, Nov. 5, 2008] this section for the significant new uses described in paragraph (a)(2) of § 721.10131 Isononanamide, N-(2- this section. ethylhexyl)-. (2) The significant new uses are: (i) Industrial, commercial, and con- (a) Chemical substance and significant sumer activities. Requirements as speci- new uses subject to reporting. (1) The fied in § 721.80(j) (emulsifier for oilfield chemical substance identified as application). isononanamide, N-(2-ethylhexyl)- (PMN (ii) [Reserved] P–07–205: CAS No. 93820–33–8) is subject (b) Specific requirements. The provi- to reporting under this section for the sions of subpart A of this part apply to significant new uses described in para- this section except as modified by this graph (a)(2) of this section. paragraph. (2) The significant new uses are: (1) Recordkeeping. Recordkeeping re- (i) Industrial, commercial, and con- quirements as specified in § 721.125 (a), sumer activities. Requirements as speci- (b), (c), and (i) are applicable to manu- fied in § 721.80(j) (defoamer for cement facturers, importers, and processors of additives in oilfield applications). this substance. (ii) [Reserved] (2) Limitations or revocation of certain (b) Specific requirements. The provi- notification requirements. The provisions sions of subpart A of this part apply to of § 721.185 apply to this section. this section except as modified by this [73 FR 65765, Nov. 5, 2008] paragraph. (1) Recordkeeping. Recordkeeping re- § 721.10130 Quino[2,3-b]acridine-7,14- quirements as specified in § 721.125 (a), dione, 5,12-dihydro-ar-[4-[[2- (b), (c), and (i) are applicable to manu- (sulfooxy)ethyl]substituted]phenyl]- facturers, importers, and processors of , monosodium salt (generic). this substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance identified generi- of § 721.185 apply to this section. cally as quino[2,3-b]acridine-7,14-dione, 5,12-dihydro-ar-[4-[[2- [73 FR 65765, Nov. 5, 2008] (sulfooxy)ethyl]substituted]phenyl]-, monosodium salt (PMN P–07–140) is § 721.10132 Phosphoramidic acid, carbomonocyclic-, diphenylester subject to reporting under this section (generic). for the significant new uses described in paragraph (a)(2) of this section. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Industrial, commercial, and con- chemical substance identified generi- sumer activities. Requirements as speci- cally as phosphoramidic acid, fied in § 721.80(j). carbomonocyclic-, diphenylester (PMN (ii) [Reserved] P–07–269) is subject to reporting under (b) Specific requirements. The provi- this section for the significant new sions of subpart A of this part apply to uses described in paragraph (a)(2) of this section except as modified by this this section. paragraph. (2) The significant new uses are:

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(i) Industrial, commercial, and con- (1) Recordkeeping. Recordkeeping re- sumer activities. Requirements as speci- quirements as specified in § 721.125 (a), fied in § 721.80 (j) and (s) (100,000 kilo- (b), (c), (d), (f), (g), (h), and (i) are appli- grams). cable to manufacturers, importers, and (ii) [Reserved] processors of this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. (3) Determining whether a specific use is (1) Recordkeeping. Recordkeeping re- subject to this section. The provisions of quirements as specified in § 721.125 (a), § 721.1725(b)(1) apply to this section. (b), (c), and (i) are applicable to manufacturers, importers, and processors of [73 FR 65766, Nov. 5, 2008] this substance. § 721.10134 Formaldehyde, polymer (2) Limitations or revocation of certain with dialkylphenylamine, notification requirements. The provisions dialkylphenol and of § 721.185 apply to this section. trimethylhexanediamine (generic). (3) Determining whether a specific use is (a) Chemical substance and significant subject to this section. The provisions of new uses subject to reporting. (1) The § 721.1725(b)(1) apply to this section. chemical substance identified generi- [73 FR 65765, Nov. 5, 2008] cally as formaldehyde, polymer with dialkylphenylamine, dialkylphenol and § 721.10133 2-Propenoic acid, 2-methyl, trimethylhexanediamine (PMN P–05–1) 2-hydroxyethyl ester, homopolymer. is subject to reporting under this sec- (a) Chemical substance and significant tion for the significant new uses de- new uses subject to reporting. (1) The scribed in paragraph (a)(2) of this sec- chemical substance identified as 2-pro- tion. penoic acid, 2-methyl, 2-hydroxyethyl (2) The significant new uses are: ester, homopolymer (PMN P–07–401; (i) Release to water. Requirements as CAS No. 25249–16–5) is subject to report- specified in § 721.90 (a)(1), (b)(1), and ing under this section for the signifi- (c)(1). cant new uses described in paragraph (ii) [Reserved] (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 (a)(4), paragraph. (a)(5), (a)(6), (b), and (c). Respirators (1) Recordkeeping. Recordkeeping re- must provide a National Institute for quirements as specified in § 721.125 (a), Occupational Safety and Health (b), (c), and (k) are applicable to manu- (NIOSH) assigned protection factor facturers, importers, and processors of (APF) of at least 1,000. A NIOSH-cer- this substance. tified supplied-air respirator operated (2) Limitations or revocation of certain in pressure demand or other positive notification requirements. The provisions pressure mode and equipped with a of § 721.185 apply to this section. tight-fitting full facepiece meets the minimum requirements for [74 FR 29994, June 24, 2009] § 721.63(a)(4). (ii) Hazard communication program. § 721.10135 Phosphinic acid, P,P- Requirements as specified in § 721.72 (a), diethyl-, zinc salt (2:1). (b), (c), (d), (e) (concentration set at 0.1 (a) Chemical substance and significant percent), (f), (g)(1)(vii), and (g)(2)(iv). new uses subject to reporting. (1) The (iii) Industrial, commercial, and con- chemical substance identified as phos- sumer activities. Requirements as speci- phinic acid, P,P-diethyl-, zinc salt (2:1) fied in § 721.80(j). (PMN P–05–11; CAS No. 284685–45–6) is (b) Specific requirements. The provi- subject to reporting under this section sions of subpart A of this part apply to for the significant new uses described this section except as modified by this in paragraph (a)(2) of this section. paragraph. (2) The significant new uses are:

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(i) Release to water. Requirements as under this section for the significant specified in § 721.90 (a)(4), (b)(4), and new uses described in paragraph (a)(2) (c)(4) (N=12). of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(1), (b)(1), and this section except as modified by this (c)(1). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), and (k) are applicable to manu- this section except as modified by this facturers, importers, and processors of paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of this substance. [74 FR 29994, June 24, 2009] (2) Limitations or revocation of certain § 721.10136 2-Propenoic acid, 2-methyl- notification requirements. The provisions , 2-hydroxyethyl ester, reaction of § 721.185 apply to this section. products with [74 FR 29995, June 24, 2009] hexakis(alkoxyalkyl)melamine (generic). § 721.10138 3-Isoxazolecarboxylic acid, (a) Chemical substance and significant 4,5-dihydro-5,5-diphenyl-, ethyl new uses subject to reporting. (1) The ester. chemical substance identified generi- (a) Chemical substance and significant cally as 2-propenoic acid, 2-methyl-, 2- new uses subject to reporting. (1) The hydroxyethyl ester, reaction products chemical substance identified as 3- with hexakis(alkoxyalkyl)melamine isoxazolecarboxylic acid, 4,5-dihydro- (PMN P–05–177) is subject to reporting 5,5-diphenyl-, ethyl ester (PMN P–05– under this section for the significant 336; CAS No. 163520–33–0) is subject to new uses described in paragraph (a)(2) reporting under this section for the sig- of this section. nificant new uses described in para- (2) The significant new uses are: graph (a)(2) of this section. (i) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(1), (b)(1), and (i) Release to water. Requirements as (c)(1). specified in § 721.90 (a)(1), (b)(1), and (ii) [Reserved] (c)(1). (b) Specific requirements. The provi- (ii) [Reserved] sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), and (k) are applicable to manu- quirements as specified in § 721.125 (a), facturers, importers, and processors of (b), (c), and (k) are applicable to manu- this substance. facturers, importers, and processors of (2) Limitations or revocation of certain this substance. notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions of § 721.185 apply to this section. [74 FR 29994, June 24, 2009] [74 FR 29995, June 24, 2009] § 721.10137 Halogenated phenoxy aromatic (generic). § 721.10139 Ethanone, 1-(1- (a) Chemical substance and significant chlorocyclopropyl)-. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as halogenated phenoxy aromatic chemical substance identified as (PMN P–05–329) is subject to reporting ethanone, 1-(1-chlorocyclopropyl)-

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(PMN P–05–776; CAS No. 63141–09–3) is § 721.10141 Oils, ginger, zingiber subject to reporting under this section purpureum. for the significant new uses described (a) Chemical substance and significant in paragraph (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified as oils, (i) Industrial, commercial, and con- ginger, zingiber purpureum (PMN P–06– sumer activities. Requirements as speci- 163; CAS No. 864662–46–4) is subject to fied in § 721.80(g). reporting under this section for the sig- (ii) Release to water. Requirements as nificant new uses described in para- specified in § 721.90 (a)(4), (b)(4), and graph (a)(2) of this section. (c)(4) (N=500). (2) The significant new uses are: (b) Specific requirements. The provi- (i) Protection in the workplace. Re- sions of subpart A of this part apply to quirements as specified in § 721.63 (a)(1), this section except as modified by this (a)(2)(i), (a)(3), (b), and (c). paragraph. (ii) Industrial, commercial, and con- (1) Recordkeeping. Recordkeeping re- sumer activities. Requirements as speci- quirements as specified in § 721.125 (a), fied in § 721.80(f). (b), (c), (i), and (k) are applicable to (b) Specific requirements. The provi- manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), [74 FR 29995, June 24, 2009] (b), (c), (d), (e), and (i) are applicable to manufacturers, importers, and proc- § 721.10140 Phosphoric acid, tin (2+) essors of this substance. salt (2:3). (2) Limitations or revocation of certain notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The chemical substance identified as phos- [74 FR 29995, June 24, 2009] phoric acid, tin (2+) salt (2:3) (PMN P– 06–33, CAS No. 15578–32–2) is subject to § 721.10142 Oxabicycloalkane car- reporting under this section for the sig- boxylic acid alkanediyl ester (ge- nificant new uses described in para- neric). graph (a)(2) of this section. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Industrial, commercial, and con- chemical substance identified generi- sumer activities. Requirements as speci- cally as oxabicycloalkane carboxylic fied in § 721.80(f). acid alkanediyl ester (PMN P–06–199) is (ii) Release to water. Requirements as subject to reporting under this section specified in § 721.90 (b)(1) and (c)(1). for the significant new uses described in paragraph (a)(2) of this section. (b) Specific requirements. The provisions of subpart A of this part apply to (2) The significant new uses are: this section except as modified by this (i) Release to water. Requirements as paragraph. specified in § 721.90 (a)(1), (b)(1), and (c)(1). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (ii) [Reserved] (b), (c), (i), and (k) are applicable to (b) Specific requirements. The provi- manufacturers, importers, and proc- sions of subpart A of this part apply to essors of this substance. this section except as modified by this paragraph. (2) Limitations or revocation of certain notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- [74 FR 29995, June 24, 2009] facturers, importers, and processors of this substance.

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(2) Limitations or revocation of certain facturers, importers, and processors of notification requirements. The provisions this substance. of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The provisions [74 FR 29995, June 24, 2009] of § 721.185 apply to this section. § 721.10143 Amines, bis (C11-14- [74 FR 29996, June 24, 2009] branched and linear alkyl). (a) Chemical substance and significant § 721.10145 Modified reaction products new uses subject to reporting. (1) The of alkyl alcohol, halogenated al- chemical substance identified as kane, substituted epoxide, and amines, bis (C11-14-branched and linear amino compound (generic). alkyl) (PMN P–06–733; CAS No. 900169– (a) Chemical substance and significant 60–0) is subject to reporting under this new uses subject to reporting. (1) The section for the significant new uses de- chemical substance identified generi- scribed in paragraph (a)(2) of this sec- cally as modified reaction products of tion. alkyl alcohol, halogenated alkane, sub- (2) The significant new uses are: stituted epoxide, and amino compound (i) Release to water. Requirements as (PMN P–06–816) is subject to reporting specified in § 721.90 (a)(1), (b)(1), and under this section for the significant (c)(1). new uses described in paragraph (a)(2) (ii) [Reserved] of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80(k) (analysis and report- (1) Recordkeeping. Recordkeeping re- ing and limitations of maximum impu- quirements as specified in § 721.125 (a), rity levels of certain fluorinated impu- (b), (c), and (k) are applicable to manu- rities) and (q). facturers, importers, and processors of (ii) [Reserved] this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. (1) Recordkeeping. Recordkeeping re- [74 FR 29995, June 24, 2009] quirements as specified in § 721.125 (a), § 721.10144 Modified thiocarbamate (b), (c), and (i) are applicable to manu- (generic). facturers, importers, and processors of this substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance identified generi- of § 721.185 apply to this section. cally as modified thiocarbamate (PMN (3) Determining whether a specific use is P–06–805) is subject to reporting under subject to this section. The provisions of this section for the significant new § 721.1725(b)(1) apply to this section. uses described in paragraph (a)(2) of this section. [74 FR 29996, June 24, 2009] (2) The significant new uses are: (i) Release to water. Requirements as § 721.10146 Partially fluorinated con- specified in § 721.90 (a)(1), (b)(1), and densation polymer (generic). (c)(1). (a) Chemical substance and significant (ii) [Reserved] new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substance identified generi- sions of subpart A of this part apply to cally as partially fluorinated condensa- this section except as modified by this tion polymer (PMN P–07–87) is subject paragraph. to reporting under this section for the (1) Recordkeeping. Recordkeeping re- significant new uses described in para- quirements as specified in § 721.125 (a), graph (a)(2) of this section. (b), (c), and (k) are applicable to manu- (2) The significant new uses are:

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(i) Industrial, commercial, and con- (2) Limitations or revocation of certain sumer activities. Requirements as speci- notification requirements. The provisions fied in § 721.80(k) (analysis and report- of § 721.185 apply to this section. ing and limitations of maximum impu- (3) Determining whether a specific use is rity levels of certain fluorinated impu- subject to this section. The provisions of rities), (l) (maximum percentage of the § 721.1725(b)(1) apply to this section. PMN substance in a non-industrial [74 FR 29996, June 24, 2009] product or distributed for use as a non- industrial product), (o) (use in a con- § 721.10148 Acryloxy alkanoic alkane sumer product that could be spray ap- derivative with mixed metal oxides plied), and (q). (generic). (ii) [Reserved] (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as acryloxy alkanoic alkane de- paragraph. rivative with mixed metal oxides (PMN (1) Recordkeeping. Recordkeeping re- P–07–330) is subject to reporting under quirements as specified in § 721.125 (a), this section for the significant new (b), (c), and (i) are applicable to manu- uses described in paragraph (a)(2) of facturers, importers, and processors of this section. this substance. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Protection in the workplace. Re- notification requirements. The provisions quirements as specified in § 721.63 (a)(1), of § 721.185 apply to this section. (a)(2)(i), (a)(3), (b) (concentration set at (3) Determining whether a specific use is 1 percent), and (c). subject to this section. The provisions of (ii) Industrial, commercial, and con- § 721.1725(b)(1) apply to this section. sumer activities. Requirements as speci- [74 FR 29996, June 24, 2009] fied in § 721.80 (j), (v)(1), (w)(1), and (x)(1). § 721.10147 Acrylate derivative of (b) Specific requirements. The provi- alkoxysilylalkane ester and mixed sions of subpart A of this part apply to metal oxides (generic). this section except as modified by this (a) Chemical substance and significant paragraph. new uses subject to reporting. (1) The (1) Recordkeeping. Recordkeeping re- chemical substance identified generi- quirements as specified in § 721.125 (a), cally as acrylate derivative of (b), (c), (d), (e), and (i) are applicable to alkoxysilylalkane ester and mixed manufacturers, importers, and proc- metal oxides (PMN P–07–198) is subject essors of this substance. to reporting under this section for the (2) Limitations or revocation of certain significant new uses described in para- notification requirements. The provisions graph (a)(2) of this section. of § 721.185 apply to this section. (2) The significant new uses are: (3) Determining whether a specific use is (i) Protection in the workplace. Re- subject to this section. The provisions of quirements as specified in § 721.63 (a)(1), § 721.1725(b)(1) apply to this section. (a)(2)(i), (a)(3), (b) (concentration set at [74 FR 29996, June 24, 2009] 1 percent), and (c). (ii) Industrial, commercial, and con- § 721.10149 Carbon black, (3- sumer activities. Requirements as speci- methylphenyl)-modified, sub- fied in § 721.80 (j), (v)(1), (w)(1), and stituted (generic). (x)(1). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as carbon black, (3- paragraph. methylphenyl)-modified, substituted (1) Recordkeeping. Recordkeeping re- (PMN P–07–522) is subject to reporting quirements as specified in § 721.125 (a), under this section for the significant (b), (c), (d), (e), and (i) are applicable to new uses described in paragraph (a)(2) manufacturers, importers, and proc- of this section. essors of this substance. (2) The significant new uses are:

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(i) Protection in the workplace. Re- (3) Determining whether a specific use is quirements as specified in § 721.63 (a)(1), subject to this section. The provisions of (a)(2)(i), (a)(3), (b) (concentration set at § 721.1725(b)(1) apply to this section. 1 percent), and (c). [74 FR 29997, June 24, 2009] (ii) Industrial, commercial, and consumer activities. Requirements as speci- § 721.10151 Modified styrene, fied in § 721.80 (j), (v)(1), (w)(1), and divinylbenzene polymer (generic). (x)(1). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as modified styrene, paragraph. divinylbenzene polymer (PMN P–07–642) (1) Recordkeeping. Recordkeeping re- is subject to reporting under this sec- quirements as specified in § 721.125 (a), tion for the significant new uses de- (b), (c), (d), (e), and (i) are applicable to scribed in paragraph (a)(2) of this sec- manufacturers, importers, and proc- tion. essors of these substances. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Protection in the workplace. Re- notification requirements. The provisions quirements as specified in § 721.63 (a)(1), of § 721.185 apply to this section. (a)(2)(i), (a)(3), (b) (concentration set at (3) Determining whether a specific use is 1 percent), and (c). subject to this section. The provisions of (ii) Industrial, commercial, and con- § 721.1725(b)(1) apply to this section. sumer activities. Requirements as specified in § 721.80 (j), (v)(1), (w)(1), and [74 FR 29997, June 24, 2009] (x)(1). (b) Specific requirements. The provi- § 721.10150 Carbon black, (4- methylphenyl)-modified, sub- sions of subpart A of this part apply to stituted (generic). this section except as modified by this paragraph. (a) Chemical substance and significant (1) Recordkeeping. Recordkeeping renew uses subject to reporting. (1) The quirements as specified in § 721.125 (a), chemical substance identified generi- (b), (c), (d), (e), and (i) are applicable to cally as carbon black, (4- manufacturers, importers, and proc- methylphenyl)-modified, substituted essors of these substances. (PMN P–07–523) is subject to reporting (2) Limitations or revocation of certain under this section for the significant notification requirements. The provisions new uses described in paragraph (a)(2) of § 721.185 apply to this section. of this section. (3) Determining whether a specific use is (2) The significant new uses are: subject to this section. The provisions of (i) Protection in the workplace. Re- § 721.1725(b)(1) apply to this section. quirements as specified in § 721.63 (a)(1), [74 FR 29997, June 24, 2009] (a)(2)(i), (a)(3), (b) (concentration set at 1 percent), and (c). § 721.10152 Oxirane, substituted (ii) Industrial, commercial, and con- silylmethyl-, hydrolysis products sumer activities. Requirements as speci- with alkanol zirconium(4+) salt and fied in § 721.80 (j), (v)(1), (w)(1), and silica, acetates (generic). (x)(1). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as oxirane, substituted paragraph. silylmethyl-, hydrolysis products with (1) Recordkeeping. Recordkeeping re- alkanol zirconium(4+) salt and silica, quirements as specified in § 721.125 (a), acetates (PMN P–07–674) is subject to (b), (c), (d), (e), and (i) are applicable to reporting under this section for the sig- manufacturers, importers, and proc- nificant new uses described in para- essors of these substances. graph (a)(2) of this section. (2) Limitations or revocation of certain (2) The significant new uses are: notification requirements. The provisions (i) Protection in the workplace. Re- of § 721.185 apply to this section. quirements as specified in § 721.63 (a)(1),

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(a)(2)(i), (a)(3), (b) (concentration set at (3) Determining whether a specific use is 1 percent), and (c). subject to this section. The provisions of (ii) Industrial, commercial, and con- § 721.1725(b)(1) apply to this section. sumer activities. Requirements as speci- [74 FR 29997, June 24, 2009] fied in § 721.80 (a), (j), (v)(1), (w)(1), and (x)(1). § 721.10154 Quaternary ammonium (b) Specific requirements. The provi- compounds, dicoco alkyldimethyl, chlorides, reaction products with sions of subpart A of this part apply to silica. this section except as modified by this paragraph. (a) Chemical substance and significant new uses subject to reporting. (1) The (1) Recordkeeping. Recordkeeping re- chemical substance identified as qua- quirements as specified in § 721.125 (a), ternary ammonium compounds, dicoco (b), (c), (d), (e), and (i) are applicable to alkyldimethyl, chlorides, reaction manufacturers, importers, and proc- products with silica (PMN P–08–157; essors of these substances. CAS No. 956147–76–5) is subject to re- (2) Limitations or revocation of certain porting under this section for the sig- notification requirements. The provisions nificant new uses described in para- of § 721.185 apply to this section. graph (a)(2) of this section. (3) Determining whether a specific use is (2) The significant new uses are: subject to this section. The provisions of (i) Protection in the workplace. Re- § 721.1725(b)(1) apply to this section. quirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at [74 FR 29997, June 24, 2009] 1 percent), and (c). (ii) Industrial, commercial, and con- § 721.10153 Modified methyl methacry- sumer activities. Requirements as speci- late, 2-hydroxyethyl methacrylate fied in § 721.80 (j), (v)(1), (w)(1), and polymer (generic). (x)(1). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as modified methyl methacrylate, paragraph. 2-hydroxyethyl methacrylate polymer (1) Recordkeeping. Recordkeeping re- (PMN P–08–6) is subject to reporting quirements as specified in § 721.125 (a), under this section for the significant (b), (c), (d), (e), and (i) are applicable to new uses described in paragraph (a)(2) manufacturers, importers, and proc- of this section. essors of these substances. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Protection in the workplace. Re- notification requirements. The provisions of § 721.185 apply to this section. quirements as specified in § 721.63 (a)(1), (3) Determining whether a specific use is (a)(2)(i), (a)(3), (b) (concentration set at subject to this section. The provisions of 1 percent), and (c). § 721.1725(b)(1) apply to this section. (ii) Industrial, commercial, and consumer activities. Requirements as speci- [74 FR 29998, June 24, 2009] fied in § 721.80 (j), (v)(1), (w)(1), and § 721.10155 Multi-walled carbon (x)(1). nanotubes (generic). (b) Specific requirements. The provi- (a) Chemical substance and significant sions of subpart A of this part apply to new uses subject to reporting—(1) The this section except as modified by this chemical substance identified generi- paragraph. cally as multi-walled carbon nanotubes (1) Recordkeeping. Recordkeeping re- (PMN P–08–177) is subject to reporting quirements as specified in § 721.125 (a), under this section for the significant (b), (c), (d), (e), and (i) are applicable to new uses described in paragraph (a)(2) manufacturers, importers, and proc- of this section. The requirements of essors of these substances. this rule do not apply to quantities of (2) Limitations or revocation of certain the chemical substance after it has notification requirements. The provisions been completely reacted (cured); incor- of § 721.185 apply to this section. porated or embedded into a polymer

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matrix that itself has been reacted (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (cured); or embedded in a permanent (National Institute for Occupational solid polymer form that is not intended Safety and Health (NIOSH)-approved to undergo further processing except air-purifying, tightfitting full-face res- for mechanical processing. pirator equipped with N100 filters), (2) The significant new uses are: (a)(6)(i), and (c). (i) Protection in the workplace. Re- (ii) Industrial, commercial, and con- quirements as specified in § 721.63(a)(1), sumer activities. Requirements as speci- (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) fied in § 721.80(k) and (q). (National Institute for Occupational (iii) Release to water. Requirements as Safety and Health (NIOSH)-approved specified in § 721.90(a)(1), (b)(1), and air-purifying, tightfitting full-face res- (c)(1). pirator equipped with N100 filters), (b) Specific requirements. The provi- (a)(6)(i), and (c). sions of subpart A of this part apply to (ii) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80(k) and (q). (1) Recordkeeping. Recordkeeping re- (iii) Release to water. Requirements as quirements as specified in § 721.125(a), specified in § 721.90(a)(1), (b)(1), and (b), (c), (d), (e), (i), and (k) are applica- (c)(1). ble to manufacturers, importers, and (b) Specific requirements. The provi- processors of this chemical substance. sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125(a), (3) Determining whether a specific use is (b), (c), (d), (e), (i), and (k) are applica- subject to this section. The provisions of ble to manufacturers, importers, and § 721.1725(b)(1) apply to this section. processors of this chemical substance. [75 FR 56889, Sept. 17, 2010] (2) Limitations or revocation of certain notification requirements. The provisions § 721.10157 Benzeneethanol,halo- of § 721.185 apply to this section. ,halocycloalkyl-,hydrazinealkyl- (ge- (3) Determining whether a specific use is neric). subject to this section. The provisions of (a) Chemical substance and significant § 721.1725(b)(1) apply to this section. new uses subject to reporting. (1) The [75 FR 56888, Sept. 17, 2010] chemical substance identified generically as benzeneethanol,halo- § 721.10156 Single-walled carbon ,halocycloalkyl-,hydrazinealkyl (PMN nanotubes (generic). P–05–775) is subject to reporting under (a) Chemical substance and significant this section for the significant new new uses subject to reporting—(1) The uses described in paragraph (a)(2) of chemical substance identified generi- this section. cally as single-walled carbon (2) The significant new uses are: nanotubes (PMN P–08–328) is subject to (i) Protection in the workplace. Re- reporting under this section for the sig- quirements as specified in § 721.63 (a)(1), nificant new uses described in para- (a)(2)(i), (a)(2)(ii), (a)(3), (b) (concentra- graph (a)(2) of this section. The re- tion set at 1.0%), and (c). quirements of this rule do not apply to (ii) Hazard communication program. quantities of the chemical substance Requirements as specified in § 721.72 (a), after it has been completely reacted (b), (c), (d), (e) (concentration set at (cured); incorporated or embedded into 1.0%), (f), (g)(1)(i) (eye irritation), a polymer matrix that itself has been (g)(1)(iii), (g)(1)(iv), (g)(1)(viii) (sen- reacted (cured); or embedded in a per- sitization), (g)(1)(ix), (g)(2)(i), (g)(2)(v), manent solid polymer form that is not (g)(3)(i), (g)(3)(ii), (g)(4) (resulting in re- intended to undergo further processing ceiving stream levels exceeding 0.1 except for mechanical processing. parts per billion (ppb)), and (g)(5). (2) The significant new uses are: (iii) Release to water. Requirements as (i) Protection in the workplace. Re- specified in § 721.90 (a)(4), (b)(4), and quirements as specified in § 721.63(a)(1), (c)(4) (N=0.1).

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(b) Specific requirements. The provi- applicable to manufacturers, import- sions of subpart A of this part apply to ers, and processors of this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), [74 FR 47886, Sept. 18, 2009] (b), (c), (d), (e), (f), (g), (h), and (k) are applicable to manufacturers, import- § 721.10159 1-Docosanamine, N,N-di- ers, and processors of this substance. methyl-. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified as 1- [74 FR 47886, Sept. 18, 2009] docosanamine, N,N-dimethyl- (PMN P– 07–587; CAS No. 21542–96–1) is subject to § 721.10158 2-Pentanone, 3,5-dichloro-. reporting under this section for the sig- (a) Chemical substance and significant nificant new uses described in para- new uses subject to reporting. (1) The graph (a)(2) of this section. chemical substance identified as 2- (2) The significant new uses are: pentanone, 3,5-dichloro- (PMN P–06–16; (i) Release to water. Requirements as CAS No. 58371–98–5) is subject to report- specified in § 721.90 (a)(1), (b)(1), and ing under this section for the signifi- (c)(1). cant new uses described in paragraph (ii) [Reserved] (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 (a)(1), paragraph. (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5), (1) Recordkeeping. Recordkeeping re- (a)(6), (b) (concentration set at 1.0%), quirements as specified in § 721.125 (a), and (c). Respirators must provide a Na- (b), (c), and (k) are applicable to manu- tional Institute for Occupational Safe- facturers, importers, and processors of ty and Health (NIOSH) assigned protec- this substance. tion factor (APF) of at least 50. The (2) Limitations or revocation of certain following NIOSH-approved respirator notification requirements. The provisions with an APF of 50 meets the minimum of § 721.185 apply to this section. requirements for § 721.63(a)(4): NIOSH- [74 FR 47887, Sept. 18, 2009] approved air-purifying, tight-fitting full facepiece respirator equipped with § 721.10160 Poly(oxy-1,2-ethanediyl), combination organic gas/vapor P100 .alpha.-[(13Z)-1-oxo-13-docosen-1-yl]- cartridges (organic vapor, acid gas, or .omega.-[[(13Z)-1-oxo-13-docosen-1- substance-specific). yl]oxy]-. (ii) Hazard communication program. (a) Chemical substance and significant Requirements as specified in § 721.72 (a), new uses subject to reporting. (1) The (b), (c), (d), (e) (concentration set at chemical substance identified as 1.0%), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), poly(oxy-1,2-ethanediyl), .alpha.-[(13Z)- (g)(1)(iv), (g)(1)(viii), (g)(1)(ix), (g)(2)(i), 1-oxo-13-docosen-1-yl]-.omega.-[[(13Z)-1- (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), oxo-13-docosen-1-yl]oxy]- (PMN P–07– (g)(3)(i), (g)(3)(ii), (g)(4) (resulting in re- 629; CAS No. 56565–72–1) is subject to receiving stream levels exceeding 0.1 porting under this section for the sig- parts per billion (ppb)), and (g)(5). nificant new uses described in para- (iii) Release to water. Requirements as graph (a)(2) of this section. specified in § 721.90 (a)(4), (b)(4), and (2) The significant new uses are: (c)(4) (N=0.1). (i) Industrial, commercial, and con- (b) Specific requirements. The provi- sumer activities. Requirements as speci- sions of subpart A of this part apply to fied in § 721.80(j). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), (d), (e), (f), (g), (h), and (k) are paragraph.

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(1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), and (i) are applicable to manu- this section except as modified by this facturers, importers, and processors of paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (i) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of (3) Determining whether a specific use is this substance. subject to this section. The provisions of (2) Limitations or revocation of certain § 721.1725(b)(1) apply to this section. notification requirements. The provisions [74 FR 47887, Sept. 18, 2009] of § 721.185 apply to this section. (3) Determining whether a specific use is § 721.10161 Substituted silyl methacry- subject to this section. The provisions of late (generic). § 721.1725(b)(1) apply to this section. (a) Chemical substance and significant [74 FR 47887, Sept. 18, 2009] new uses subject to reporting. (1) The chemical substance identified generi- § 721.10163 Chloro fluoro alkane (ge- cally as substituted silyl methacrylate neric). (PMN P–08–3) is subject to reporting under this section for the significant (a) Chemical substance and significant new uses described in paragraph (a)(2) new uses subject to reporting. (1) The of this section. chemical substance identified generi- (2) The significant new uses are: cally as chloro fluoro alkane (PMN P– (i) Release to water. Requirements as 08–33) is subject to reporting under this specified in § 721.90 (a)(1), (b)(1), and section for the significant new uses de- (c)(1). scribed in paragraph (a)(2) of this sec- (ii) [Reserved] tion. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80 (f) and (s) (50,000 kilo- (1) Recordkeeping. Recordkeeping re- grams). quirements as specified in § 721.125 (a), (ii) Release to water. Requirements as (b), (c), and (k) are applicable to manu- specified in § 721.90 (b)(1) and (c)(1). facturers, importers, and processors of (b) Specific requirements. The provi- this substance. sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this section. (1) Recordkeeping. Recordkeeping re- [74 FR 47887, Sept. 18, 2009] quirements as specified in § 721.125 (a), (b), (c), (i), and (k) are applicable to § 721.10162 1,3 Dioxolane-4-butanol, 2- manufacturers, importers, and proc- ethenyl-. essors of this substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The notification requirements. The provisions chemical substance identified as 1,3 of § 721.185 apply to this section. dioxolane-4-butanol, 2-ethenyl- (PMN P–08–24; CAS No. 2421–08–1) is subject to [74 FR 47887, Sept. 18, 2009] reporting under this section for the significant new uses described in para- § 721.10164 Benzenecarboximidamide, N-hydroxy-4-nitro-. graph (a)(2) of this section. (2) The significant new uses are: (a) Chemical substance and significant (i) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified as fied in § 721.80(j). benzenecarboximidamide, N-hydroxy-4- (ii) [Reserved] nitro- (PMN P–08–36; CAS No. 1613–86–1)

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is subject to reporting under this sec- § 721.10166 1,3-Cyclohexanedione, 2-[2- tion for the significant new uses de- chloro-4-(methylsulfonyl)-3-[(2,2,2- scribed in paragraph (a)(2) of this sec- trifluoroethoxy)methyl]benzoyl]-, tion. ion(1-), potassium salt (1:1). (2) The significant new uses are: (a) Chemical substance and significant (i) Release to water. Requirements as new uses subject to reporting. (1) The specified in § 721.90 (a)(1), (b)(1), and chemical substance identified as 1,3- (c)(1). cyclohexanedione, 2-[2-chloro-4- (ii) [Reserved] (methylsulfonyl)-3-[(2,2,2- (b) Specific requirements. The provi- trifluoroethoxy)methyl]benzoyl]-, ion(1-), potassium salt (1:1) (PMN P–08– sions of subpart A of this part apply to 180; CAS No. 1121649–70–4) is subject to this section except as modified by this reporting under this section for the sig- paragraph. nificant new uses described in para- (1) Recordkeeping. Recordkeeping re- graph (a)(2) of this section. quirements as specified in § 721.125 (a), (2) The significant new uses are: (b), (c), and (k) are applicable to manu- (i) Release to water. Requirements as facturers, importers, and processors of specified in § 721.90 (a)(4), (b)(4), and this substance. (c)(4) (N= 0.1). (2) Limitations or revocation of certain (ii) [Reserved] notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to this section except as modified by this [74 FR 47888, Sept. 18, 2009] paragraph. § 721.10165 Carbonotrithioic acid, (1) Recordkeeping. Recordkeeping re- bis(phenylmethyl) ester. quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- (a) Chemical substance and significant facturers, importers, and processors of new uses subject to reporting. (1) The this substance. chemical substance identified as (2) Limitations or revocation of certain carbonotrithioic acid, notification requirements. The provisions bis(phenylmethyl) ester (PMN P–08–138; of § 721.185 apply to this section. CAS No.26504–29–0) is subject to reporting under this section for the signifi- [74 FR 47888, Sept. 18, 2009] cant new uses described in paragraph § 721.10167 Tetrafluoro nitrotoluene (a)(2) of this section. (generic). (2) The significant new uses are: (a) Chemical substance and significant (i) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified generi- fied in § 721.80(f). cally as tetrafluoro nitrotoluene (PMN (ii) Release to water. Requirements as P–08–212) is subject to reporting under specified in § 721.90 (b)(1) and (c)(1). this section for the significant new (b) Specific requirements. The provi- uses described in paragraph (a)(2) of sions of subpart A of this part apply to this section. this section except as modified by this (2) The significant new uses are: paragraph. (i) Release to water. Requirements as (1) Recordkeeping. Recordkeeping re- specified in § 721.90 (a)(1), (b)(1), and quirements as specified in § 721.125 (a), (c)(1). (b), (c), (i), and (k) are applicable to (ii) [Reserved] manufacturers, importers, and proc- (b) Specific requirements. The provi- essors of this substance. sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this section. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), [74 FR 47888, Sept. 18, 2009] (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

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(2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. (3) Determining whether a specific use is [74 FR 47888, Sept. 18, 2009] subject to this section. The provisions of § 721.1725(b)(1) apply to this section. § 721.10168 Cesium tungsten oxide. [75 FR 4993, Feb. 1, 2010] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.10170 Polyoxyethylene chemical substance identified as ce- polyalkylarylphenylether sulfate sium tungsten oxide (PMN P–08–275; ammonium salt (generic). CAS No. 52350–17–1) is subject to report- (a) Chemical substance and significant ing under this section for the signifi- new uses subject to reporting. (1) The cant new uses described in paragraph chemical substance identified generi- (a)(2) of this section. cally as polyoxyethylene (2) The significant new uses are: polyalkylarylphenylether sulfate am- (i) Industrial, commercial, and con- monium salt (PMN P–03–197) is subject sumer activities. Requirements as speci- to reporting under this section for the fied in § 721.80 (v)(2), (w)(2), and (x)(2). significant new uses described in para- (ii) [Reserved] graph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80(j). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), and (i) are applicable to manu- this section except as modified by this facturers, importers, and processors of paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (i) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of [74 FR 47888, Sept. 18, 2009] this substance. (2) Limitations or revocation of certain § 721. 10169 Cyclopentane, methoxy-. notification requirements. The provisions of § 721.185 apply to this section. (a) Chemical substance and significant (3) Determining whether a specific use is new uses subject to reporting. (1) The subject to this section. The provisions of chemical substance identified as § 721.1725(b)(1) apply to this section. cyclopentane, methoxy- (PMN P–03–141; CAS No. 5614–37–9) is subject to report- [75 FR 4993, Feb. 1, 2010] ing under this section for the signifi- § 721.10171 1H-benz(e)indolium, 1,1,2,3- cant new uses described in paragraph tetramethyl-, 4- (a)(2) of this section. methylbenzenesulfonic acid (1:1). (2) The significant new uses are: (a) Chemical substance and significant (i) Industrial, commercial, and con- new uses subject to reporting. (1) The sumer activities. Requirements as speci- chemical substance identified as 1H- fied in 721.80(j). benz(e)indolium, 1,1,2,3-tetramethyl-, 4- (ii) [Reserved] methylbenzenesulfonic acid (1:1) (PMN (b) Specific requirements. The provi- P–03–285; CAS No. 141914–99–0) is subject sions of subpart A of this part apply to to reporting under this section for the this section except as modified by this significant new uses described in para- paragraph. graph (a)(2) of this section. (1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a), (i) Protection in the workplace. Re- (b), (c), and (i) are applicable to manu- quirements as specified in § 721.63 (a)(4), facturers, importers, and processors of (a)(5), (b) (concentration set at 1 per- this substance. cent), and (c). Respirators must provide

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a National Institute for Occupational (b), (c), and (k) are applicable to manu- Safety and Health (NIOSH) assigned facturers, importers, and processors of protection factor (APF) of at least 10. this substance. The following NIOSH-approved res- (2) Limitations or revocation of certain pirators with an APF of 10–25 meet the notification requirements. The provisions minimum requirements for of § 721.185 apply to this section. § 721.63(a)(4): Air-purifying, tight-fit- [75 FR 4994, Feb. 1, 2010] ting respirator equipped with N100 (if oil aerosols absent), R100, or P100 fil- § 721.10173 Silanamine,1,1,1-triethoxy- ters (either half- or full-face); powered N,N-diethyl-. air-purifying respirator equipped with (a) Chemical substance and significant a loose-fitting hood or helmet and High new uses subject to reporting. (1) The Efficiency Particulate Air (HEPA) fil- chemical substance identified as ters; powered air-purifying respirator silanamine,1,1,1-triethoxy-N,N-diethyl- equipped with a tight-fitting facepiece (PMN P–03–793; CAS No. 35077–00–0) is (either half- or full-face) and HEPA fil- subject to reporting under this section ters; supplied-air respirator operated in for the significant new uses described pressure demand or continuous flow in paragraph (a)(2) of this section. mode and equipped with a hood or hel- (2) The significant new uses are: met, or tight-fitting facepiece (either (i) Industrial, commercial, and con- half- or full-face). sumer activities. Requirements as speci- (ii) Industrial, commercial, and con- fied in § 721.80(f). sumer activities. Requirements as speci- (ii) [Reserved] fied in § 721.80(s) (11,000 kilograms). (b) Specific requirements. The provi- (b) Specific requirements. The provisions of subpart A of this part apply to sions of subpart A of this part apply to this section except as modified by this this section except as modified by this paragraph. paragraph. (1) Recordkeeping. Recordkeeping re- (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), quirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manu- (b), (c), (d), and (i) are applicable to facturers, importers, and processors of manufacturers, importers, and proc- this substance. essors of this substance. (2) Limitations or revocation of certain (2) Limitations or revocation of certain notification requirements. The provisions notification requirements. The provisions of § 721.185 apply to this section. of § 721.185 apply to this section. [75 FR 4994, Feb. 1, 2010] [75 FR 4994, Feb. 1, 2010] § 721.10174 1-Propanaminium, 3- § 721.10172 Alkylamide derivative (ge- amino-N-(carboxymethyl)-N,N-di- neric). methyl-, N-peanut-oil acyl derivs., (a) Chemical substance and significant inner salts. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as alkylamide derivative (PMN chemical substance identified as 1- P–03–633) is subject to reporting under Propanaminium, 3-amino-N- this section for the significant new (carboxymethyl)-N,N-dimethyl-, N-pea- uses described in paragraph (a)(2) of nut-oil acyl derivs., inner salts (PMN this section. P–04–139; CAS No. 691401–28–2) is subject (2) The significant new uses are: to reporting under this section for the (i) Release to water. Requirements as significant new uses described in para- specified in § 721.90 (a)(4), (b)(4), and graph (a)(2) of this section. (c)(4) (N =1). (2) The significant new uses are: (ii) [Reserved] (i) Protection in the workplace. Re- (b) Specific requirements. The provi- quirements as specified in § 721.63 (a)(1), sions of subpart A of this part apply to (a)(2)(i), (a)(3), (b) (concentration set at this section except as modified by this 1 percent), and (c). paragraph. (ii) Industrial, commercial, and con- (1) Recordkeeping. Recordkeeping re- sumer activities. Requirements as speci- quirements as specified in § 721.125 (a), fied in § 721.80(j).

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(b) Specific requirements. The provi- reporting under this section for the sig- sions of subpart A of this part apply to nificant new uses described in para- this section except as modified by this graph (a)(2) of this section. paragraph. (2) The significant new uses are: (1) Recordkeeping. Recordkeeping re- (i) Release to water. Requirements as quirements as specified in § 721.125 (a), specified in § 721.90 (a)(1), (b)(1), and (b), (c), (d), (e), and (i) are applicable to (c)(1). manufacturers, importers, and proc- (ii) [Reserved] essors of this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. (3) Determining whether a specific use is (1) Recordkeeping. Recordkeeping re- subject to this section. The provisions of quirements as specified in § 721.125 (a), § 721.1725(b)(1) apply to this section. (b), (c), and (k) are applicable to manu- [75 FR 4994, Feb. 1, 2010] facturers, importers, and processors of this substance. § 721.10175 1-Propanaminium, N-(3- (2) Limitations or revocation of certain aminopropyl)-2-hydroxy-N,N-di- notification requirements. The provisions methyl-3-sulfo-, N-(C12-18 and C18- of § 721.185 apply to this section. unsatd. acyl) derivs., inner salts. (a) Chemical substance and significant [75 FR 4995, Feb. 1, 2010] new uses subject to reporting. (1) The § 721.10177 Phosphoric acid, yt- chemical substance identified as 1- trium(3+) salt (1:1). Propanaminium, N-(3-aminopropyl)-2- hydroxy-N,N-dimethyl-3-sulfo-, N-(C12- (a) Chemical substance and significant 18 and C18-unsatd. acyl) derivs., inner new uses subject to reporting. (1) The salts (PMN P–04–141; CAS No. 691400–36– chemical substance identified as phos- 9) is subject to reporting under this phoric acid, yttrium(3+) salt (1:1) (PMN section for the significant new uses de- P–04–153; CAS No. 13990–54–0) is subject scribed in paragraph (a)(2) of this sec- to reporting under this section for the tion. significant new uses described in para- (2) The significant new uses are: graph (a)(2) of this section. (i) Release to water. Requirements as (2) The significant new uses are: specified in § 721.90 (a)(4), (b)(4), and (i) Industrial, commercial, and con- (c)(4) (N=6). sumer activities. Requirements as speci- (ii) [Reserved] fied in § 721.80(f). (b) Specific requirements. The provi- (ii) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (b)(4) and (c)(4) this section except as modified by this (N=6). paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), and (k) are applicable to manu- paragraph. facturers, importers, and processors of (1) Recordkeeping. Recordkeeping re- this substance. quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), (i), and (k) are applicable to notification requirements. The provisions manufacturers, importers, and proc- of § 721.185 apply to this section. essors of this substance. (2) Limitations or revocation of certain [75 FR 4994, Feb. 1, 2010] notification requirements. The provisions § 721.10176 Amides, peanut-oil, N-[3- of § 721.185 apply to this section. (dimethylamino)propyl]. [75 FR 4995, Feb. 1, 2010] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.10178 Distillates (Fischer- chemical substance identified as am- Tropsch), hydroisomerized middle, ides, peanut-oil, N-[3- C10-13-branched alkane fraction. (dimethylamino)propyl] (PMN P–04– (a) Chemical substance and significant 144; CAS No. 691400–76–7) is subject to new uses subject to reporting. (1) The

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chemical substance identified as dis- er than 500 daltons). Representative tillates (Fischer-Tropsch), samples of the PMN substances must hydroisomerized middle, C10-13- be analyzed and determined to comply branched alkane fraction (PMN P–04– with these requirements both at the 319; CAS No. 642928–30–1) is subject to time of initial commencement and an- reporting under this section for the sig- nually thereafter. nificant new uses described in para- (ii) [Reserved] graph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Protection in the workplace. Re- this section except as modified by this quirements as specified in § 721.63 (a)(1), paragraph. (a)(2)(i), (a)(3), (a)(4), (a)(5), (b) (con- (1) Recordkeeping. Recordkeeping re- centration set at 0.1 percent), and (c). quirements as specified in § 721.125 (a), Respirators must provide a National (b), (c), and (i) are applicable to manu- Institute for Occupational Safety and facturers, importers, and processors of Health (NIOSH) assigned protection these substances. factor (APF) of at least 100. The fol- (2) Limitations or revocation of certain lowing NIOSH-approved respirator notification requirements. The provisions meets the minimum requirements for of § 721.185 apply to this section. § 721.63(a)(4): Supplied-air respirator operated in pressure demand or contin- [75 FR 4995, Feb. 1, 2010] uous flow mode and equipped with a tight-fitting full facepiece. § 721.10180 Trifunctional acrylic ester (generic). (ii) Industrial, commercial, and consumer activities. Requirements as speci- (a) Chemical substance and significant fied in § 721.80(f). new uses subject to reporting. (1) The (iii) Release to water. Requirements as chemical substance identified generi- specified in § 721.90 (b)(1) and (c)(1). cally as trifunctional acrylic ester (b) Specific requirements. The provi- (PMN P–04–692) is subject to reporting sions of subpart A of this part apply to under this section for the significant this section except as modified by this new uses described in paragraph (a)(2) paragraph. of this section. (1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a), (i) Industrial, commercial, and con- (b), (c), (d), (e), (i), and (k) are applica- sumer activities. Requirement as speci- ble to manufacturers, importers, and fied in § 721.80(k) (no manufacture or processors of this substance. import of the PMN substance unless (2) Limitations or revocation of certain the mean number of moles of the notification requirements. The provisions ethoxy group is greater than or equal of § 721.185 apply to this section. to 8). Representative samples of the PMN substance must be analyzed and [75 FR 4995, Feb. 1, 2010] determined to comply with these re- § 721.10179 Copolymers of phenol and quirements both at the time of initial aromatic hydocarbon (generic). commencement and annually thereafter. (a) Chemical substance and significant (ii) [Reserved] new uses subject to reporting. (1) The (b) Specific requirements. The provi- chemical substances identified generi- sions of subpart A of this part apply to cally as copolymers of phenol and aro- this section except as modified by this matic hydocarbon (PMNs P–04–346 and paragraph. P–04–347) are subject to reporting under (1) Recordkeeping. Recordkeeping re- this section for the significant new quirements as specified in § 721.125 (a), uses described in paragraph (a)(2) of (b), (c), and (i) are applicable to manu- this section. facturers, importers, and processors of (2) The significant new uses are: this substance. (i) Industrial, commercial, and con- (2) sumer activities. Requirements as speci- Limitations or revocation of certain fied in § 721.80(k) (no manufacture or notification requirements. The provisions import of the PMN substances unless of § 721.185 apply to this section. the average molecular weight is great- [75 FR 4995, Feb. 1, 2010]

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§ 721.10181 Halide salt of an sumer for the purpose of servicing, alkylamine (generic). maintenance, and disposal involving (a) Chemical substance and significant the PMN substance). new uses subject to reporting. (1) The (ii) [Reserved] chemical substance identified generi- (b) Specific requirements. The provi- cally as halide salt of an alkylamine sions of subpart A of this part apply to (PMN P–07–453) is subject to reporting this section except as modified by this under this section for the significant paragraph. new uses described in paragraph (a)(2) (1) Recordkeeping. Recordkeeping re- of this section. quirements as specified in § 721.125 (a), (2) The significant new uses are: (b), (c), and (i) are applicable to manu- (i) Industrial, commercial, and con- facturers, importers, and processors of sumer activities. Requirements as speci- this chemical substance. fied in § 721.80(j). (2) Limitations or revocation of certain (ii) [Reserved] notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to [75 FR 65994, Oct. 27, 2010] this section except as modified by this paragraph. § 721.10183 Multi-walled carbon (1) Recordkeeping. Recordkeeping re- nanotubes (generic). quirements as specified in § 721.125 (a), (a) Chemical substance and significant (b), (c), and (i) are applicable to manu- new uses subject to reporting. (1) The facturers, importers, and processors of chemical substance identified generi- this substance. cally as multi-walled carbon nanotubes (2) Limitations or revocation of certain (PMN P–08–199) is subject to reporting notification requirements. The provisions under this section for the significant of § 721.185 apply to this section. new uses described in paragraph (a)(2) (3) Determining whether a specific use is of this section. The requirements of subject to this section. The provisions of this rule do not apply to quantities of § 721.1725(b)(1) apply to this section. the chemical substance after it has [75 FR 4995, Feb. 1, 2010] been completely reacted (cured), incorporated or embedded into a polymer § 721.10182 1-Propene, 2,3,3,3- matrix that itself has been reacted tetrafluoro-. (cured), or embedded in a permanent (a) Chemical substance and significant solid polymer form that is not intended new uses subject to reporting. (1) The to undergo further processing except chemical substance identified as 1- for mechanical processing. propene, 2,3,3,3-tetrafluoro- (PMN P–07– (2) The significant new uses are: 601; CAS No. 754–12–1; also known as (i) Protection in the workplace. Re- HFO–1234yf) is subject to reporting quirements as specified in § 721.63 (a)(1), under this section for the significant (a)(2)(i), (a)(2)(ii), (a)(4), (a)(5) (National new uses described in paragraph (a)(2) Institute for Occupational Safety and of this section. Health (NIOSH)-approved full-face res- (2) The significant new uses are: pirators with N100 cartridges), (a)(6)(i), (i) Industrial, commercial, and con- and (c). sumer activities. Requirements as speci- (ii) Industrial, commercial, and con- fied in § 721.80(j) (use other than as a re- sumer activities. Requirements as speci- frigerant in motor vehicle air condi- fied in § 721.80(j) (additive/filler for tioning systems in new passenger cars polymer composites and support media and vehicles (i.e., as defined in 40 CFR for industrial catalysts). 82.32 (c) and (d)); § 721.80 (m) (commer- (b) Specific requirements. The provi- cial use other than in new passenger sions of subpart A of this part apply to cars and vehicles in which the charging this section except as modified by this of motor vehicle air conditioning sys- paragraph. tems with the PMN substance was done (1) Recordkeeping. Recordkeeping re- by the motor vehicle original equip- quirements as specified in § 721.125 (a), ment manufacturer (OEM)); and (b), (c), (d), and (i) are applicable to § 721.80(o) (distribution in commerce of manufacturers, importers, and proc- products intended for use by a con- essors of this chemical substance.

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(2) Limitations or revocation of certain (2) The significant new uses are: notification requirements. The provisions (i) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as speci- [76 FR 26192, May 6, 2011] fied in § 721.80(y)(l). (ii) [Reserved] § 721.10184 Aliphatic triamine (ge- (b) Specific requirements. The provi- neric). sions of subpart A of this part apply to (a) Chemical substance and significant this section except as modified by this new uses subject to reporting. (1) The paragraph. chemical substance identified generi- (1) Recordkeeping. Recordkeeping re- cally as aliphatic triamine (PMN P–02– quirements as specified in § 721.125 (a), 996) is subject to reporting under this (b), (c), and (i) are applicable to manu- section for the significant new uses de- facturers, importers, and processors of scribed in paragraph (a)(2) of this sec- this substance. tion. (2) Limitations or revocation of certain (2) The significant new uses are: notification requirements. The provisions (i) Industrial, commercial, and con- of § 721.185 apply to this section. sumer activities. Requirements as speci- [75 FR 35986, June 24, 2010] fied in § 721.80(y)(1). (ii) Release to water. Requirements as § 721.10186 Ethylhexyl oxetane (ge- specified in § 721.90 (a)(1), (b)(1), and neric). (c)(1). (a) Chemical substance and significant (b) Specific requirements. The provi- new uses subject to reporting. (1) The sions of subpart A of this part apply to chemical substance identified generi- this section except as modified by this cally as ethylhexyl oxetane (PMN P– paragraph. 04–132) is subject to reporting under (1) Recordkeeping. Recordkeeping re- this section for the significant new quirements as specified in § 721.125 (a), uses described in paragraph (a)(2) of (b), (c), (i), and (k) are applicable to this section. The requirements of this manufacturers, importers, and proc- rule do not apply to quantities of the essors of this substance. PMN substance after it has been com- (2) Limitations or revocation of certain pletely reacted (cured). notification requirements. The provisions of § 721.185 apply to this section. (2) The significant new uses are: (i) Protection in the workplace. Re- [75 FR 35986, June 24, 2010] quirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(3)(i), (b) (con- § 721.10185 1,2-Propanediol, 3- centration set at 1.0 percent), and (c). (diethylamino)-, polymers with 5- isocyanato-1- (isocyanatomethyl)- Polyvinyl Alcohol gloves with a thick- 1,3,3-trimethylcyclohexane, pro- ness of no less than 31.3 mils or pylene glycol and reduced Me Silvershield/4H sleeves with a thick- esters of reduced polymd. oxidized ness of no less than 2.7 mils have been tetrafluoroethylene, 2-ethyl-1- shown to satisfy the requirements of hexanol-blocked, acetates (salts). § 721.63(a)(3)(i) for up to 8 hours. (a) Chemical substance and significant (ii) Hazard communication program. new uses subject to reporting. (1) The Requirements as specified in § 721.72 (a), chemical substance identified as 1,2- (b), (c), (d), (e) (concentration set at 1.0 propanediol, 3-(diethylamino)-, poly- percent), (f), (g)(1)(iii), (g)(1)(iv), mers with 5-isocyanato-1- (g)(2)(i), (g)(2)(v), (g)(3)(ii), and (g)(5). (isocyanatomethyl)-1,3,3- (iii) Industrial, commercial, and con- trimethylcyclohexane, propylene gly- sumer activities. Requirements as speci- col and reduced Me esters of reduced fied in § 721.80(k). polymd. oxidized tetrafluoroethylene, (b) Specific requirements. The provi- 2-ethyl-1-hexanol-blocked, acetates sions of subpart A of this part apply to (salts) (PMN P–03–106; CAS No. 328389– this section except as modified by this 90–8) is subject to reporting under this paragraph. section for the significant new uses de- (1) Recordkeeping. Recordkeeping re- scribed in paragraph (a)(2) of this sec- quirements as specified in § 721.125 (a), tion. (b), (c), (d), (e), (f), (g), (h), and (i) are

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applicable to manufacturers, import- § 721.10188 Fatty acids, tall-oil, reac- ers, and processors of this substance. tion products with 4-methyl-2- (2) Limitations or revocation of certain pentanone and aliphatic polyamine notification requirements. The provisions (generic). of § 721.185 apply to this section. (a) Chemical substance and significant (3) Determining whether a specific use is new uses subject to reporting. (1) The subject to this section. The provisions of chemical substance identified generi- § 721.1725(b)(1) apply to this section. cally as fatty acids, tall-oil, reaction [75 FR 35986, June 24, 2010] products with 4-methyl-2-pentanone and aliphatic polyamine (PMN P–05– § 721.10187 4-Morpholinepropanamine, 186, Chemical B) is subject to reporting N-(1,3-dimethylbutylidene)-. under this section for the significant (a) Chemical substance and significant new uses described in paragraph (a)(2) new uses subject to reporting. (1) The of this section. chemical substance identified as 4- (2) The significant new uses are: morpholinepropanamine, N-(1,3- (i) Release to water. Requirements as dimethylbutylidene)- (PMN P–05–186, specified in § 721.90 (a)(4), (b)(4), and Chemical A; CAS No. 1003863–30–6) is (c)(4) (N=10). However, when this chem- subject to reporting under this section ical substance is released in combina- for the significant new uses described tion with any of the substances in in paragraph (a)(2) of this section. § 721.10187, § 721.10189, or § 721.10190, then (2) The significant new uses are: the value of N shall instead be adjusted (i) Release to water. Requirements as according to the following formula: specified in § 721.90 (a)(4), (b)(4), and [(N1 x Release1) + (N2 x Release2) + (c)(4) (N=10). However, when this chem- (N3 x Release3) + (N4 x Release4)] / ical substance is released in combina- (Release1 + Release2 + Release3 + tion with any of the substances in Release4) = Adjusted N § 721.10188, § 721.10189, or § 721.10190, then Where the ‘‘N’’ variables are the N the value of N shall instead be adjusted values for each of the four substances according to the following formula: as specified in this section and [(N1 x Release1) + (N2 x Release2) + § 721.10187, § 721.10189, § 721.10190 and the (N3 x Release3) + (N4 x Release4)] / ‘‘Release’’ variables are the number of (Release1 + Release2 + Release3 + kilograms released of the respective Release4) = Adjusted N four substances (in units of kg/site/day) Where the ‘‘N’’ variables are the N per § 721.91(a). values for each of the four substances (ii) [Reserved] as specified in this section and (b) Specific requirements. The provi- § 721.10188, § 721.10189, § 721.10190 and the sions of subpart A of this part apply to ‘‘Release’’ variables are the number of this section except as modified by this kilograms released of the respective paragraph. four substances (in units of kg/site/day) (1) Recordkeeping. Recordkeeping re- per § 721.91(a). quirements as specified in § 721.125 (a), (ii) [Reserved] (b), (c), and (k) are applicable to manu- (b) Specific requirements. The provi- facturers, importers, and processors of sions of subpart A of this part apply to this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- [75 FR 35987, June 24, 2010] facturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. [75 FR 35986, June 24, 2010]

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§ 721.10189 Fatty acids, tall-oil, reac- § 721.10190 Formaldehyde, polymer tion products with (butoxymethyl) with aliphatic diamine and phenol, oxirane formaldehyde-phenol poly- reaction products with 4-methyl-2- mer glycidyl ether, pentanone (generic). morpholinepropanamine, propylene (a) Chemical substance and significant glycol diamine and aliphatic new uses subject to reporting. (1) The polyamine, N-(1,3 chemical substance identified generi- -dimethylbutylidene) derivs (generic). cally as formaldehyde, polymer with aliphatic diamine and phenol, reaction (a) Chemical substance and significant products with 4-methyl-2-pentanone new uses subject to reporting. (1) The (PMN P–05–186; Chemical D) is subject chemical substance identified generi- to reporting under this section for the cally as fatty acids, tall-oil, reaction significant new uses described in para- products with (butoxymethyl) oxirane graph (a)(2) of this section. formaldehyde-phenol polymer glycidyl (2) The significant new uses are: ether, morpholinepropanamine, pro- (i) Release to water. Requirements as pylene glycol diamine and aliphatic specified in § 721.90 (a)(4), (b)(4), and polyamine, N-(1,3 -dimethylbutylidene) (c)(4) (N=10). However, when this chem- derivs (PMN P–05–186, Chemical C) is ical substance is released in combina- subject to reporting under this section tion with any of the substances in for the significant new uses described § 721.10187, § 721.10188, or § 721.10189, then in paragraph (a)(2) of this section. the value of N shall instead be adjusted (2) The significant new uses are: according to the following formula: (i) Release to water. Requirements as [(N1 x Release1) + (N2 x Release2) + specified in § 721.90 (a)(4), (b)(4), and (N3 x Release3) + (N4 x Release4)] / (c)(4) (N=10). However, when this chem- (Release1 + Release2 + Release3 + ical substance is released in combina- Release4) = Adjusted N tion with any of the substances in Where the ‘‘N’’ variables are the N § 721.10187, § 721.10188, or § 721.10190, then values for each of the four substances the value of N shall instead be adjusted as specified in this section and according to the following formula: §§ 721.10187, 721.10188, 721.10189 and the [(N1 x Release1) + (N2 x Release2) + ‘‘Release’’ variables are the number of (N3 x Release3) + (N4 x Release4)] / kilograms released of the respective (Release1 + Release2 + Release3 + four substances (in units of kg/site/day) Release4) = Adjusted N per § 721.91(a). Where the ‘‘N’’ variables are the N (ii) [Reserved] values for each of the four substances (b) Specific requirements. The provi- as specified in this section and sions of subpart A of this part apply to § 721.10187, § 721.10188, § 721.10190 and the this section except as modified by this paragraph. ‘‘Release’’ variables are the number of kilograms released of the respective (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), four substances (in units of kg/site/day) (b), (c), and (k) are applicable to manu- per § 721.91(a). facturers, importers, and processors of (ii) [Reserved] this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. (1) Recordkeeping. Recordkeeping re- [75 FR 35987, June 24, 2010] quirements as specified in § 721.125 (a), § 721.10191 Amides, coco, N-[3- (b), (c), and (k) are applicable to manu- (dibutylamino)propyl]. facturers, importers, and processors of this substance. (a) Chemical substance and significant (2) Limitations or revocation of certain new uses subject to reporting. (1) The chemical substance identified as am- notification requirements. The provisions ides, coco, N-[3-(dibutylamino)propyl] of § 721.185 apply to this section. (PMN P–06–262; CAS No. 851544–20–2) is [75 FR 35987, June 24, 2010] subject to reporting under this section

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for the significant new uses described butyl-N-(2-carboxyethyl)-, N-coco acyl in paragraph (a)(2) of this section. derivs., inner salts (PMN P–06–263, (2) The significant new uses are: Chemical B; CAS No. 851545–17–0) is (i) Release to water. Requirements as subject to reporting under this section specified in § 721.90 (a)(1), (b)(1), and for the significant new uses described (c)(1). in paragraph (a)(2) of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to this section except as modified by this specified in § 721.90 (a)(1), (b)(1), and paragraph. (c)(1). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), and (k) are applicable to manu- sions of subpart A of this part apply to facturers, importers, and processors of this section except as modified by this this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (k) are applicable to manu- [75 FR 35988, June 24, 2010] facturers, importers, and processors of this substance. § 721.10192 Amides, coco, N-[3- (2) Limitations or revocation of certain (dibutylamino)propyl], acrylates. notification requirements. The provisions (a) Chemical substance and significant of § 721.185 apply to this section. new uses subject to reporting. (1) The chemical substance identified as am- [75 FR 35988, June 24, 2010] ides, coco, N-[3-(dibutylamino)propyl], acrylates (PMN P–06–263, Chemical A; § 721.10194 CAS No. 851545–09–0) is subject to re- Dialkylcocoamidoalkylpropionate (generic). porting under this section for the significant new uses described in para- (a) Chemical substance and significant graph (a)(2) of this section. new uses subject to reporting. (1) The (2) The significant new uses are: chemical substance identified generi- (i) Release to water. Requirements as cally as specified in § 721.90 (a)(1), (b)(1), and dialkylcocoamidoalkylpropionate (c)(1). (PMN P–06–264) is subject to reporting (ii) [Reserved] under this section for the significant (b) Specific requirements. The provi- new uses described in paragraph (a)(2) sions of subpart A of this part apply to of this section. this section except as modified by this (2) The significant new uses are: paragraph. (1) Recordkeeping. Recordkeeping re- (i) Release to water. Requirements as quirements as specified in § 721.125 (a), specified in § 721.90 (a)(1), (b)(1), and (b), (c), and (k) are applicable to manu- (c)(1). facturers, importers, and processors of (ii) [Reserved] this substance. (b) Specific requirements. The provi- (2) Limitations or revocation of certain sions of subpart A of this part apply to notification requirements. The provisions this section except as modified by this of § 721.185 apply to this section. paragraph. [75 FR 35988, June 24, 2010] (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), § 721.10193 1-Butanaminium, N-(3- (b), (c), and (k) are applicable to manu- aminopropyl)-N-butyl-N-(2- facturers, importers, and processors of carboxyethyl)-, N-coco acyl derivs., this substance. inner salts. (2) Limitations or revocation of certain (a) Chemical substance and significant notification requirements. The provisions new uses subject to reporting. (1) The of § 721.185 apply to this section. chemical substance identified as 1- butanaminium, N-(3-aminopropyl)-N- [75 FR 35988, June 24, 2010]

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§ 721.10195 (2) Limitations or revocation of certain Dialkylcornoilamidoalkylamine (ge- notification requirements. The provisions neric). of § 721.185 apply to this section. (a) Chemical substance and significant [75 FR 35988, June 24, 2010] new uses subject to reporting. (1) The chemical substance identified generi- § 721.10197 cally as Dialkycornoilamidoalkylbetaine dialkylcornoilamidoalkylamine (PMN (generic). P–06–265) is subject to reporting under (a) Chemical substance and significant this section for the significant new new uses subject to reporting. (1) The uses described in paragraph (a)(2) of chemical substance identified generi- this section. cally as (2) The significant new uses are: dialkycornoilamidoalkylbetaine (PMN (i) Release to water. Requirements as P–06–266, Chemical B) is subject to reporting under this section for the sig- specified in § 721.90 (a)(1), (b)(1), and nificant new uses described in para- (c)(1). graph (a)(2) of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(1), (b)(1), and this section except as modified by this (c)(1). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), and (k) are applicable to manu- this section except as modified by this facturers, importers, and processors of paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of this substance. [75 FR 35988, June 24, 2010] (2) Limitations or revocation of certain notification requirements. The provisions § 721.10196 Dialkylcornoilamidoacrylate (ge- of § 721.185 apply to this section. neric). [75 FR 35988, June 24, 2010] (a) Chemical substance and significant new uses subject to reporting. (1) The § 721.10198 Dialkylcornoilamidopropionate (ge- chemical substance identified generi- neric). cally as dialkylcornoilamidoacrylate (PMN P–06–266, Chemical A) is subject (a) Chemical substance and significant to reporting under this section for the new uses subject to reporting. (1) The significant new uses described in para- chemical substance identified generi- graph (a)(2) of this section. cally as dialkylcornoilamidopropionate (PMN P–06–267) is subject to reporting (2) The significant new uses are: under this section for the significant (i) Release to water. Requirements as new uses described in paragraph (a)(2) specified in § 721.90 (a)(1), (b)(1), and of this section. (c)(1). (2) The significant new uses are: (ii) [Reserved] (i) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(1), (b)(1), and sions of subpart A of this part apply to (c)(1). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), and (k) are applicable to manu- paragraph. facturers, importers, and processors of (1) Recordkeeping. Recordkeeping re- this substance. quirements as specified in § 721.125 (a),

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(b), (c), and (k) are applicable to manu- choose to follow the new chemical ex- facturers, importers, and processors of posure limit (NCEL) provisions listed this substance. in the Toxic Substances Control Act (2) Limitations or revocation of certain (TSCA) section 5(e) consent order for notification requirements. The provisions this substance. The NCEL is 0.14 mg/m3 of § 721.185 apply to this section. as an 8–hour time-weighted average. Persons who wish to pursue NCELs as []75 FR 35989, June 24, 2010] an alternative to the § 721.63 respirator § 721.10199 Substituted aliphatic requirements may request to do so amine (generic). under § 721.30. Persons whose § 721.30 re- (a) Chemical substance and significant quests to use the NCELs approach are new uses subject to reporting. (1) The approved by EPA will receive NCELs chemical substance identified generi- provisions comparable to those con- cally as substituted aliphatic amine tained in the corresponding section 5(e) (PMN P–06–702) is subject to reporting consent order. under this section for the significant (ii) Hazard communication program. new uses described in paragraph (a)(2) Requirements as specified in § 721.72 (a), of this section. The requirements of (b), (c), (d), (e) (concentration set at 1.0 this rule do not apply to quantities of percent), (f), (g)(1)(i), (g)(1)(ii), the PMN substance after it has been (g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), completely reacted (cured). (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (2) The significant new uses are: (g)(4)(iii), and (g)(5). (i) Protection in the workplace. Re- (iii) Industrial, commercial, and con- quirements as specified in § 721.63 (a)(1), sumer activities. Requirements as speci- (a)(2), (a)(3)(i), (a)(4), (a)(5), (a)(6), (b) fied in § 721.80(r). (concentration set at 1.0 percent), and (iv) Release to water. Requirements as (c). Ansell NEOX style 9–912 gloves specified in § 721.90 (a)(1), (b)(1), and have been shown to satisfy the require- (c)(1). ments of § 721.63(a)(3)(i) for up to 110 (b) Specific requirements. The provi- minutes. Respirators must provide a sions of subpart A of this part apply to National Institute for Occupational this section except as modified by this Safety and Health (NIOSH) assigned paragraph. protection factor (APF) of at least 50. (1) Recordkeeping. Recordkeeping re- The following NIOSH-approved res- quirements as specified in § 721.125 (a), pirators meet the requirements for (b), (c), (d), (e), (f), (g), (h), (i), and (k) § 721.63(a)(4): Air purifying, tight-fitting are applicable to manufacturers, im- full-face respirator equipped with the porters, and processors of this sub- appropriate combination cartridges, stance. cartridges should be tested and ap- (2) Limitations or revocation of certain proved for the gas/vapor substance (i.e., notification requirements. The provisions organic vapor, acid gas, or substance- of § 721.185 apply to this section. specific cartridge) and should include a (3) Determining whether a specific use is particulate filter (N100 if oil aerosols subject to this section. The provisions of are absent, R100, or P100); powered air- § 721.1725(b)(1) apply to this section. purifying respirator equipped with a [75 FR 35989, June 24, 2010] tight-fitting facepiece (full-face) and the appropriate combination car- § 721.10200 Benzenacetonitrile, tridges, cartridges should be tested and cyclohexylidene-alkyl substituted approved for the gas/vapor substance (generic). (i.e., organic vapor, acid gas, or sub- (a) Chemical substance and significant stance-specific cartridges) and should new uses subject to reporting. (1) The include High Efficiency Particulate Air chemical substance identified generi- (HEPA) filters; supplied-air respirator cally as benzenacetonitrile, operated in pressure demand or contin- cyclohexylidene-alkyl substituted uous flow mode and equipped with a (PMN P–09–75) is subject to reporting tight-fitting face piece (full-face). As under this section for the significant an alternative to the respiratory renew uses described in paragraph (a)(2) quirements listed here, a manufac- of this section. turer, importer, or processor may (2) The significant new uses are:

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(i) Industrial, commercial, and con- phosphonium, tetrabutyl-, hydroxide sumer activities. Requirements as speci- (1:1) (PMN P–08–742; CAS No. 14518–69–5) fied in § 721.80(s) (10,000 kg). is subject to reporting under this sec- (ii) Release to water. Requirements as tion for the significant new uses de- specified in § 721.90 (a)(4), (b)(4), and scribed in paragraph (a)(2) of this sec- (c)(4) (N=123). tion. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Release to water. Requirements as this section except as modified by this specified in § 721.90 (a)(1), (b)(1), and paragraph. (c)(1). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), (i), and (k) are applicable to sions of subpart A of this part apply to manufacturers, importers, and proc- this section except as modified by this essors of this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (k) are applicable to manu- [75 FR 35989, June 24, 2010] facturers, importers, and processors of this substance. § 721.10202 Benzoic acid, 4-chloro-2- (2) Limitations or revocation of certain [(substituted)azo]-, strontium salt notification requirements. The provisions (1:1) (generic). of § 721.185 apply to this section. (a) Chemical substance and significant new uses subject to reporting. (1) The [75 FR 57182, Sept. 20, 2010] chemical substance identified generi- § 721.10204 Aryloxyacrylate (generic). cally as benzoic acid, 4-chloro-2- [(substituted)azo]-, strontium salt (1:1) (a) Chemical substance and significant (PMN P–08–701) is subject to reporting new uses subject to reporting. (1) The under this section for the significant chemical substance identified generi- new uses described in paragraph (a)(2) cally as aryloxyacrylate (PMN P–08– of this section. 754) is subject to reporting under this (2) The significant new uses are: section for the significant new uses de- (i) Industrial, commercial, and con- scribed in paragraph (a)(2) of this sec- sumer activities. Requirements as speci- tion. fied in § 721.80(j). (2) The significant new uses are: (ii) [Reserved] (i) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(4), (b)(4), and sions of subpart A of this part apply to (c)(4) (N=3). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), and (i) are applicable to manu- paragraph. facturers, importers, and processors of (1) Recordkeeping. Recordkeeping re- this substance. quirements as specified in § 721.125 (a), (2) Limitations or revocation of certain (b), (c), and (k) are applicable to manu- notification requirements. The provisions facturers, importers, and processors of of § 721.185 apply to this section. this substance. (3) Determining whether a specific use is (2) Limitations or revocation of certain subject to this section. The provisions of notification requirements. The provisions § 721.1725(b)(1) apply to this section. of § 721.185 apply to this section. [75 FR 57182, Sept. 20, 2010] [75 FR 57182, Sept. 20, 2010]

§ 721.10203 Phosphonium, tetrabutyl-, § 721.10205 Formaldehyde, polymer hydroxide (1:1). with 1,3-benzenediol and 1,1′- (a) Chemical substance and significant methylenebis[isocyanatobenzene]. new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified as new uses subject to reporting. (1) The

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chemical substance identified as form- (2) Limitations or revocation of certain aldehyde, polymer with 1,3-benzenediol notification requirements. The provisions and 1,1′- of § 721.185 apply to this section. methylenebis[isocyanatobenzene] (PMN P–09–4; CAS No. 1067881–45–1) is [75 FR 57182, Sept. 20, 2010] subject to reporting under this section § 721.10207 1,3- for the significant new uses described Cyclohexanedimethanamine, N1,N3- in paragraph (a)(2) of this section. bis(2-methylpropylidene)-. (2) The significant new uses are: (a) Chemical substance and significant (i) Release to water. Requirements as new uses subject to reporting. (1) The specified in § 721.90 (a)(1), (b)(1), and chemical substance identified as 1,3- (c)(1). cyclohexanedimethanamine, N1,N3- (ii) [Reserved] bis(2-methylpropylidene)- (PMN P–09– (b) Specific requirements. The provi- 38; CAS No. 173904–11–5) is subject to re- sions of subpart A of this part apply to porting under this section for the sig- this section except as modified by this nificant new uses described in para- paragraph. graph (a)(2) of this section. (1) Recordkeeping. Recordkeeping re- (2) The significant new uses are: quirements as specified in § 721.125 (a), (i) Release to water. Requirements as (b), (c), and (k) are applicable to manu- specified in § 721.90 (a)(1), (b)(1), and facturers, importers, and processors of (c)(1). this substance. (ii) [Reserved] (2) Limitations or revocation of certain notification requirements. The provisions (b) Specific requirements. The provi- of § 721.185 apply to this section. sions of subpart A of this part apply to this section except as modified by this [75 FR 57182, Sept. 20, 2010] paragraph. (1) Recordkeeping. Recordkeeping re- § 721.10206 4-Cyclohexene-1,2- quirements as specified in § 721.125 (a), dicarboxylic acid, 1,2-bis(2- (b), (c), and (k) are applicable to manu- oxiranylmethyl) ester. facturers, importers, and processors of (a) Chemical substance and significant this substance. new uses subject to reporting. (1) The (2) Limitations or revocation of certain chemical substance identified as 4- notification requirements. The provisions cyclohexene-1,2-dicarboxylic acid, 1,2- of § 721.185 apply to this section. bis(2-oxiranylmethyl) ester (PMN P–09– 19; CAS No. 21544–03–6) is subject to re- [75 FR 57183, Sept. 20, 2010] porting under this section for the significant new uses described in para- § 721.10208 Amines, di-C11-14-isoalkyl, C13-rich. graph (a)(2) of this section. (2) The significant new uses are: (a) Chemical substance and significant (i) Protection in the workplace. Re- new uses subject to reporting. (1) The quirements as specified in § 721.63 (a)(1), chemical substance identified as (a)(2)(i), (a)(2)(iii), (a)(3), (b) (con- amines, di-C11-14-isoalkyl, C13-rich centration set at 0.1 percent), and (c). (PMN P–09–71; CAS No. 1005516–89–1) is (ii) Hazard communication program. subject to reporting under this section Requirements as specified in § 721.72 (c), for the significant new uses described (e) (concentration set at 0.1 percent), in paragraph (a)(2) of this section. (g)(1)(i), (g)(1)(iv), (g)(1)(vi), (g)(1)(vii), (2) The significant new uses are: (g)(2)(i) and (g)(2)(v). (i) Release to water. Requirements as (b) Specific requirements. The provi- specified in § 721.90 (a)(4), (b)(4), and sions of subpart A of this part apply to (c)(4) (N=2). this section except as modified by this (ii) [Reserved] paragraph. (b) Specific requirements. The provi- (1) Recordkeeping. Recordkeeping re- sions of subpart A of this part apply to quirements as specified in § 721.125 (a), this section except as modified by this (b), (c), (d), (e), (f), and (h) are applica- paragraph. ble to manufacturers, importers, and (1) Recordkeeping. Recordkeeping re- processors of this substance. quirements as specified in § 721.125 (a),

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(b), (c), and (k) are applicable to manu- (b) Specific requirements. The provi- facturers, importers, and processors of sions of subpart A of this part apply to this substance. this section except as modified by this (2) Limitations or revocation of certain paragraph. notification requirements. The provisions (1) Recordkeeping. Recordkeeping re- of § 721.185 apply to this section. quirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manu- [75 FR 57183, Sept. 20, 2010] facturers, importers, and processors of § 721.10209 Epoxy terminated, this substance. hydrolyzed trialkoxysilane and (2) Limitations or revocation of certain glycidyl ether of phenol-formalde- notification requirements. The provisions hyde resin (generic). of § 721.185 apply to this section. (a) Chemical substance and significant [75 FR 57183, Sept. 20, 2010] new uses subject to reporting. (1) The chemical substance identified generi- § 721.10211 Octadecanoic acid, reac- cally as epoxy terminated, hydrolyzed tion products with trialkoxysilane and glycidyl ether of diethylenetriamine and urea, ace- phenol-formaldehyde resin (PMN P–09– tates. 120) is subject to reporting under this (a) Chemical substance and significant section for the significant new uses de- new uses subject to reporting. (1) The scribed in paragraph (a)(2) of this sec- chemical substance identified as octa- tion. decanoic acid, reaction products with (2) The significant new uses are: diethylenetriamine and urea, acetates (i) Release to water. Requirements as (PMN P–09–172; CAS No. 84962–05–0) is specified in § 721.90 (a)(1), (b)(1), and subject to reporting under this section (c)(1). for the significant new uses described (ii) [Reserved] in paragraph (a)(2) of this section. (b) Specific requirements. The provi- (2) The significant new uses are: sions of subpart A of this part apply to (i) Industrial, commercial, and con- this section except as modified by this sumer activities. Requirements as speci- paragraph. fied in § 721.80(s) (10,000 kilograms). (1) Recordkeeping. Recordkeeping re- (ii) [Reserved] quirements as specified in § 721.125 (a), (b) Specific requirements. The provi- (b), (c), and (k) are applicable to manu- sions of subpart A of this part apply to facturers, importers, and processors of this section except as modified by this this substance. paragraph. (2) Limitations or revocation of certain (1) Recordkeeping. Recordkeeping re- notification requirements. The provisions quirements as specified in § 721.125 (a), of § 721.185 apply to this section. (b), (c), and (i) are applicable to manufacturers, importers, and processors of [75 FR 57183, Sept. 20, 2010] this substance. § 721.10210 Soybean oil, epoxidized, re- (2) Limitations or revocation of certain action products with notification requirements. The provisions diethanolamine. of § 721.185 apply to this section. (a) Chemical substance and significant [75 FR 57183, Sept. 20, 2010] new uses subject to reporting. (1) The chemical substance identified as soy- § 721.10212 1,2-Ethanediol, reaction bean oil, epoxidized, reaction products products with epichlorohydrin. with diethanolamine (PMN P–09–130; (a) Chemical substance and significant CAS No. 1002761–12–7) is subject to renew uses subject to reporting. (1) The porting under this section for the sig- chemical substance identified as 1,2- nificant new uses described in para- ethanediol, reaction products with graph (a)(2) of this section. epichlorohydrin (PMN P–09–241; CAS (2) The significant new uses are: No. 705265–31–2) is subject to reporting (i) Release to water. Requirements as under this section for the significant specified in § 721.90 (a)(1), (b)(1), and new uses described in paragraph (a)(2) (c)(1). of this section. (ii) [Reserved] (2) The significant new uses are:

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(i) Industrial, commercial, and con- this section for the significant new sumer activities. Requirements as speci- uses described in paragraph (a)(2) of fied in § 721.80(s) (100,000 kilograms). this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Release to water. Requirements as sions of subpart A of this part apply to specified in § 721.90 (a)(1), (b)(1), and this section except as modified by this (c)(1). paragraph. (ii) [Reserved] (1) Recordkeeping. Recordkeeping re- (b) Specific requirements. The provi- quirements as specified in § 721.125 (a), sions of subpart A of this part apply to (b), (c), and (i) are applicable to manu- this section except as modified by this facturers, importers, and processors of paragraph. this substance. (1) Recordkeeping. Recordkeeping re- (2) Limitations or revocation of certain quirements as specified in § 721.125 (a), notification requirements. The provisions (b), (c), and (k) are applicable to manu- of § 721.185 apply to this section. facturers, importers, and processors of this substance. [75 FR 57183, Sept. 20, 2010] (2) Limitations or revocation of certain § 721.10213 Polyether polyester copoly- notification requirements. The provisions mer phosphate (generic). of § 721.185 apply to this section. (a) Chemical substance and significant [75 FR 57184, Sept. 20, 2010 new uses subject to reporting. (1) The chemical substance identified generi- § 721.10215 Benzenepropanol, .beta.- cally as polyether polyester copolymer methyl-. phosphate (PMN P–09–253) is subject to (a) Chemical substance and significant reporting under this section for the sig- new uses subject to reporting. (1) The nificant new uses described in para- chemical substance identified as graph (a)(2) of this section. benzenepropanol, .beta.-methyl- (PMN (2) The significant new uses are: P–09–385; CAS No.7384–80–7) is subject (i) Release to water. Requirements as to reporting under this section for the specified in § 721.90 (a)(1), (b)(1), and significant new uses described in para- (c)(1). graph (a)(2) of this section. (ii) [Reserved] (2) The significant new uses are: (b) Specific requirements. The provi- (i) Protection in the workplace. Re- sions of subpart A of this part apply to quirements as specified in § 721.63 (a)(1), this section except as modified by this (a)(2)(i), (a)(3), (b) (concentration set at paragraph. 1.0 percent), and (c). (1) Recordkeeping. Recordkeeping re- (ii) Industrial, commercial, and con- quirements as specified in § 721.125 (a), sumer activities. Requirements as speci- (b), (c), and (k) are applicable to manu- fied in § 721.80(g). facturers, importers, and processors of (b) Specific requirements. The provi- this substance. sions of subpart A of this part apply to (2) Limitations or revocation of certain this section except as modified by this notification requirements. The provisions paragraph. of § 721.185 apply to this section. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), [75 FR 57183, Sept. 20, 2010] (b), (c), (d), (e), and (i) are applicable to § 721.10214 manufacturers, importers, and proc- Poly(oxyalkylenediyl),.alpha.-sub- essors of this substance. stituted carbomonocycle-.omega.- (2) Limitations or revocation of certain substituted carbomonocycle (ge- notification requirements. The provisions neric). of § 721.185 apply to this section. (a) Chemical substance and significant [75 FR 57184, Sept. 20, 2010] new uses subject to reporting. (1) The chemical substance identified generi- § 721.10216 2-Propenoic acid, 3-(5,5,6- cally as poly(oxyalkylenediyl),.alpha.- trimethylbicyclo[2.2.1]hept-2- substituted carbomonocycle-.omega.- yl)cyclohexyl ester]. substituted carbomonocycle (PMN P– (a) Chemical substance and significant 09–286) is subject to reporting under new uses subject to reporting. (1) The

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chemical substance identified as 2-pro- § 721.10218 2-Propenoic acid, 2-mehtyl- penoic acid, 3-(5,5,6- , C12-15-branched and linear alkyl trimethylbicyclo[2.2.1]hept-2- esters, telomers with alkyl 2- yl)cyclohexyl ester (PMN P–09–411; [[(alkylthio)thioxomethyl]thio]-2- CAS No. 903876–45–9) is subject to re- alkanoate, aminoalkyl methacrylate and alkyl methacrylate, tert-Bu 2- porting under this section for the sig- ethylhexanoperoxoate-initiated (ge- nificant new uses described in para- neric). graph (a)(2) of this section. (a) Chemical substance and significant (2) The significant new uses are: new uses subject to reporting. (1) The (i) Disposal. Requirements as speci- chemical substance identified generi- fied in § 721.85 (a)(1), (b)(1), and (c)(1). cally as 2-propenoic acid, 2-methyl-, (ii) Release to water. Requirements as C12-15-branched and linear alkyl esters, specified in § 721.90 (a)(1), (b)(1), and telomers with alkyl 2- (c)(1). [[(alkylthio)thioxomethyl]thio]-2- (b) Specific requirements. The provi- alkanoate, aminoalkyl methacrylate sions of subpart A of this part apply to and alkyl methacrylate, tert-Bu 2- this section except as modified by this ethylhexanoperoxoate-initiated (PMN paragraph. P–09–436) is subject to reporting under (1) Recordkeeping. Recordkeeping re- this section for the significant new quirements as specified in § 721.125 (a), uses described in paragraph (a)(2) of (b), (c), (j), and (k) are applicable to this section. manufacturers, importers, and proc- (2) The significant new uses are: essors of this substance. (i) Release to water. Requirements as (2) Limitations or revocation of certain specified in § 721.90(a)(1). notification requirements. The provisions (ii) [Reserved] of § 721.185 apply to this section. (b) Specific requirements. The provi- [75 FR 57184, Sept. 20, 2010] sions of subpart A of this part apply to this section except as modified by this § 721.10217 Branched and linear alco- paragraph. hols (generic). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (a) Chemical substance and significant (b), (c), and (k) are applicable to manu- new uses subject to reporting. (1) The facturers, importers, and processors of chemical substance identified generi- this substance. cally as branched and linear alcohols (2) Limitations or revocation of certain (PMN P–09–426) is subject to reporting notification requirements. The provisions under this section for the significant of § 721.185 apply to this section. new uses described in paragraph (a)(2) of this section. [75 FR 57184, Sept. 20, 2010] (2) The significant new uses are: (i) Release to water. Requirements as § 721.10219 Butanamide,N-[substituted specified in § 721.90 (a)(4), (b)(4), and phenyl]- [(alkoxynitrophenyl)diazenyl]-3- (c)(4) (N=1). oxo- (generic). (ii) [Reserved] (b) Specific requirements. The provi- (a) Chemical substance and significant sions of subpart A of this part apply to new uses subject to reporting. (1) The this section except as modified by this chemical substance identified generically as butanamide,N-[substituted paragraph. phenyl]-(alkoxynitrophenyl)diazenyl]- (1) Recordkeeping. Recordkeeping re- 3-oxo- (PMN P–09–451) is subject to requirements as specified in § 721.125 (a), porting under this section for the sig- (b), (c), and (k) are applicable to manu- nificant new uses described in para- facturers, importers, and processors of graph (a)(2) of this section. this substance. (2) The significant new uses are: (2) Limitations or revocation of certain (i) Release to water. Requirements as notification requirements. The provisions specified in § 721.90 (a)(1), (b)(1), and of § 721.185 apply to this section. (c)(1). [75 FR 57184, Sept. 20, 2010] (ii) [Reserved]

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(b) Specific requirements. The provi- (ii) [Reserved] sions of subpart A of this part apply to (b) Specific requirements. The provi- this section except as modified by this sions of subpart A of this part apply to paragraph. this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), and (k) are applicable to manu- quirements as specified in § 721.125 (a), facturers, importers, and processors of (b), (c), and (k) are applicable to manu- this substance. facturers, importers, and processors of (2) Limitations or revocation of certain this substance. notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions [75 FR 57184, Sept. 20, 2010] of § 721.185 apply to this section.

§ 721.10220 Phosphoric acid, polymer [75 FR 57185, Sept. 20, 2010] with cycloaliphatic diglycidyl ether, alkylethers (generic). § 721.10222 Styrenyl surface treated manganese ferrite (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The (a) Chemical substance and significant chemical substance identified generi- new uses subject to reporting. (1) The cally as phosphoric acid, polymer with chemical substance identified generi- cycloaliphatic diglycidyl ether, cally as styrenyl surface treated man- alkylethers (PMN P–09–478) is subject ganese ferrite (PMN P–09–581) is subject to reporting under this section for the to reporting under this section for the significant new uses described in para- significant new uses described in paragraph (a)(2) of this section. graph (a)(2) of this section. (2) The significant new uses are: (2) The significant new uses are: (i) Release to water. Requirements as (i) Protection in the workplace. Re- specified in § 721.90 (a)(1), (b)(1), and quirements as specified in § 721.63 (a)(4), (c)(1). (a)(5), (a)(6), (b) (concentration set at (ii) [Reserved] 1.0 percent), and (c). Respirators must (b) Specific requirements. The provi- provide a National Institute for Occu- sions of subpart A of this part apply to pational Safety and Health (NIOSH) as- this section except as modified by this signed protection factor (APF) of at paragraph. least 10. The following NIOSH-approved (1) Recordkeeping. Recordkeeping re- respirators with an APF of 10–25 meet quirements as specified in § 721.125 (a), the minimum requirements for (b), (c), and (k) are applicable to manu- § 721.63(a)(4): Air-purifying, tight-fit- facturers, importers, and processors of ting respirator equipped with N100 (if this substance. oil aerosols absent), R100, or P100 fil- (2) Limitations or revocation of certain ters (either half- or full-face); powered notification requirements. The provisions air-purifying respirator equipped with of § 721.185 apply to this section. a loose-fitting hood or helmet and High [75 FR 57185, Sept. 20, 2010] Efficiency Particulate Air (HEPA) filters; powered air-purifying respirator § 721.10221 3-Nonen-1-ol, 1-acetate, equipped with a tight-fitting facepiece (3Z)-. (either half- or full-face) and HEPA fil- (a) Chemical substance and significant ters; supplied-air respirator operated in new uses subject to reporting. (1) The pressure demand or continuous flow chemical substance identified as 3- mode and equipped with a hood or hel- nonen-1-ol, 1-acetate, (3Z)- (PMN P–09– met, or tight-fitting facepiece (either 542; CAS No. 13049–88–2) is subject to re- half- or full-face). porting under this section for the sig- (ii) Industrial, commercial, and con- nificant new uses described in para- sumer activities. Requirements as speci- graph (a)(2) of this section. fied in § 721.80(j) (raw material inter- (2) The significant new uses are: mediate used in the manufacture of po- (i) Release to water. Requirements as lymerized pigments). specified in § 721.90 (a)(4), (b)(4), and (b) Specific requirements. The provi- (c)(4) (N=9). sions of subpart A of this part apply to

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this section except as modified by this (1) Recordkeeping. Recordkeeping re- paragraph. quirements as specified in § 721.125 (a), (1) Recordkeeping. Recordkeeping re- (b), (c), (d), and (i) are applicable to quirements as specified in § 721.125 (a), manufacturers, importers, and proc- (b), (c), (d), and (i) are applicable to essors of this substance. manufacturers, importers, and proc- (2) Limitations or revocation of certain essors of this substance. notification requirements. The provisions (2) Limitations or revocation of certain of § 721.185 apply to this section. notification requirements. The provisions [75 FR 57185, Sept. 20, 2010] of § 721.185 apply to this section. [75 FR 57185, Sept. 20, 2010] § 721.10224 Diglycidylaniline (generic). (a) Chemical substance and significant § 721.10223 Styrenyl surface treated new uses subject to reporting. (1) The manganese ferrite with acrylic chemical substance identified generi- ester polymer (generic). cally as diglycidylaniline (PMN P–10–9) (a) Chemical substance and significant is subject to reporting under this sec- new uses subject to reporting. (1) The tion for the significant new uses de- chemical substance identified generi- scribed in paragraph (a)(2) of this sec- cally as styrenyl surface treated man- tion. ganese ferrite with acrylic ester poly- (2) The significant new uses are: mer (PMN P–09–582) is subject to re- (i) Protection in the workplace. Re- porting under this section for the sig- quirements as specified in § 721.63 (a)(1), nificant new uses described in para- (a)(2)(i), (a)(3), (b) (concentration set at graph (a)(2) of this section. 0.1 percent), and (c). (2) The significant new uses are: (ii) Industrial, commercial, and con- (i) Protection in the workplace. Re- sumer activities. Requirements as speci- quirements as specified in § 721.63 (a)(4), fied in § 721.80 (v)(1), (w)(1), and (x)(1). (a)(5), (a)(6), (b) (concentration set at (iii) Release to water. Requirements as 1.0 percent), and (c). Respirators must specified in § 721.90 (a)(1), (b)(1), and provide a National Institute for Occu- (c)(1). pational Safety and Health (NIOSH) as- (b) Specific requirements. The provi- signed protection factor (APF) of at sions of subpart A of this part apply to least 10. The following NIOSH-approved this section except as modified by this respirators with an APF of 10–25 meet paragraph. the minimum requirements for (1) Recordkeeping. Recordkeeping re- § 721.63(a)(4): Air-purifying, tight-fit- quirements as specified in § 721.125 (a), ting respirator equipped with N100 (if (b), (c), (d), (e), (i), and (k) are applica- oil aerosols absent), R100, or P100 fil- ble to manufacturers, importers, and ters (either half- or full-face); powered processors of this substance. air-purifying respirator equipped with (2) Limitations or revocation of certain a loose-fitting hood or helmet and High notification requirements. The provisions Efficiency Particulate Air (HEPA) fil- of § 721.185 apply to this section. ters; powered air-purifying respirator [75 FR 57186, Sept. 20, 2010] equipped with a tight-fitting facepiece (either half- or full-face) and HEPA fil- § 721.10225 Quino[2,3-b] acridine-7,14- ters; supplied-air respirator operated in dione, 2,9-dichloro-5,12-dihydro [4- pressure demand or continuous flow [[2-(sulfooxy) ethyl] substituted] mode and equipped with a hood or hel- phenyl]-, sodium salt (1:1) (generic). met, or tight-fitting facepiece (either (a) Chemical substance and significant half- or full-face). new uses subject to reporting. (1) The (ii) Industrial, commercial, and con- chemical substance identified generi- sumer activities. Requirements as speci- cally as quino[2,3-b] acridine-7,14-dione, fied in § 721.80(j) (polymerized pigment 2,9-dichloro-5,12-dihydro [4-[[2- used in the manufacture of electronic (sulfooxy) ethyl] substituted] phenyl]-, inks). sodium salt (1:1) (PMN P–10–14) is sub- (b) Specific requirements. The provi- ject to reporting under this section for sions of subpart A of this part apply to the significant new uses described in this section except as modified by this paragraph (a)(2) of this section. paragraph. (2) The significant new uses are:

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(i) Protection in the workplace. Re- stances Control Act (15 U.S.C. quirements as specified in § 721.63 (a)(1), 2604(a)(1)(A)) for the manufacture of: (a)(2)(i), (a)(2)(iii), (a)(3), (b) (con- (i) Chemical substances manufac- centration set at 1.0 percent), and (c). tured in quantities of 10,000 kilograms (ii) Industrial, commercial, and con- or less per year. sumer activities. Requirements as speci- (ii) Chemical substances with low en- fied in § 721.80 (j), (v)(1), (w)(1), and vironmental releases and human expo- (x)(1). sures. (b) Specific requirements. The provi- (2) To manufacture a new chemical sions of subpart A of this part apply to substance under the terms of this ex- this section except as modified by this emption a manufacturer must: paragraph. (i) Submit a notice of intent to man- (1) Recordkeeping. Recordkeeping re- ufacture 30 days before manufacture quirements as specified in § 721.125 (a), begins, as required under paragraph (e) (b), (c), (d), (e), and (i) are applicable to of this section. manufacturers, importers, and proc- (ii) Comply with all other provisions essors of this substance. of this section. (2) Limitations or revocation of certain notification requirements. The provisions (3) This section does not apply to of § 721.185 apply to this section. microorganisms subject to part 725 of (3) Determining whether a specific use is this chapter. subject to this section. The provisions of (b) Definitions. The following defini- § 721.1725(b)(1) apply to this section. tions apply to this subpart. (1) Act means the Toxic Substances [75 FR 57186, Sept. 20, 2010] Control Act (15 U.S.C. 2601 et seq). (2) Consumer means a private indi- PART 723—PREMANUFACTURE vidual who uses a chemical substance NOTIFICATION EXEMPTIONS or any product containing the chemical substance in or around a permanent or Subpart A [Reserved] temporary household or residence, during recreation, or for any personal use Subpart B—Specific Exemptions or enjoyment. Sec. (3) Environment has the same mean- 723.50 Chemical substances manufactured in ing as in section 3 of the Act (15 U.S.C. quantities of 10,000 kilograms or less per 2602). year, and chemical substances with low (4) Environmental transformation prod- environmental releases and human expo- uct means any chemical substance re- sures. 723.175 Chemical substances used in or for sulting from the action of environ- the manufacture or processing of instant mental processes on a parent com- photographic and peel-apart film arti- pound that changes the molecular iden- cles. tity of the parent compound. 723.250 Polymers. (5) Metabolite means a chemical enti- AUTHORITY: 15 U.S.C. 2604. ty produced by one or more enzymatic or nonenzymatic reactions as a result Subpart A [Reserved] of exposure of an organism to a chemical substance. (6) Serious acute effects means human Subpart B—Specific Exemptions disease processes or other adverse ef- § 723.50 Chemical substances manufac- fects that have short latency periods tured in quantities of 10,000 kilo- for development, result from short- grams or less per year, and chem- term exposure, or are a combination of ical substances with low environ- these factors and that are likely to re- mental releases and human expo- sult in death, severe or prolonged inca- sures. pacitation, disfigurement, or severe or (a) Purpose and scope. (1) This section prolonged loss of the ability to use a grants an exemption from the normal bodily or intellectual function premanufacture notice requirements of with a consequent impairment of nor- section 5(a)(1)(A) of the Toxic Sub- mal activities.

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(7) Serious chronic effects means the general population to the new human disease processes or other ad- chemical substance during all manu- verse effects that have long latency pe- facturing, processing, distribution in riods for development, result from commerce, use, and disposal of the sub- long-term exposure, are long-term ill- stance: nesses, or are a combination of these (A) No dermal exposure. factors and that are likely to result in (B) No inhalation exposure (except as death, severe or prolonged incapacita- described in paragraph (c)(2)(iv) of this tion, disfigurement, or severe or pro- section. longed loss of the ability to use a nor- (C) Exposure in drinking water no mal bodily or intellectual function greater than a 1 milligram per year (es- with a consequent impairment of nor- timated average dosage resulting from mal activities. drinking water exposure in streams (8) Significant environmental effects from the maximum allowable con- means: centration level from ambient surface (i) Any irreversible damage to bio- water releases established under para- logical, commercial, or agricultural re- graph (c)(2)(iii) of this section or a sources of importance to society; higher concentration authorized by (ii) Any reversible damage to biologi- EPA under paragraph (c)(2)(iii) of this cal, commercial, or agricultural re- section). sources of importance to society if the (ii) Workers. For exposure of workers damage persists beyond a single gen- to the new chemical substance during eration of the damaged resource or be- all manufacturing, processing, dis- yond a single year; or tribution in commerce, use and dis- (iii) Any known or reasonably antici- posal of the substance: pated loss of members of an endangered (A) No dermal exposure (this cri- or threatened species. Endangered or terion is met if adequate dermal expo- threatened species are those species sure controls are used in accordance identified as such by the Secretary of with applicable EPA guidance). the Interior in accordance with the En- (B) No inhalation exposure (this cri- dangered Species Act, as amended (16 terion is considered to be met if ade- U.S.C. 1531). quate inhalation exposure controls are (9) Site means a contiguous property used in accordance with applicable unit. Property divided only by a public EPA guidance). right-of-way is one site. There may be (iii) Ambient surface water. For ambi- more than one manufacturing plant on ent surface water releases, no releases a single site. resulting in surface water concentra- (10) The terms byproduct, EPA, im- tions above 1 part per billion, cal- porter, impurity, known to or reasonably culated using the methods prescribed ascertainable, manufacture, manufac- in §§ 721.90 and 721.91, unless EPA has turer, new chemical substance, person, approved a higher surface water con- possession or control, and test data have centration supported by relevant and the same meanings as in § 720.3 of this scientifically valid data submitted to chapter. EPA in a notice under paragraph (e) of (c) Exemption categories. Except as this section on the substance or a close provided in paragraph (d) of this sec- structural analogue of the substance tion, this exemption applies to: which demonstrates that the new sub- (1) Any manufacturer of a new chem- stance will not present an unreason- ical substance manufactured in quan- able risk of injury to aquatic species or tities of 10,000 kilograms or less per human health at the higher concentra- year under the terms of this exemption. tion. (iv) Incineration. For ambient air re- (2) Any manufacturer of a new chem- leases from incineration, no releases of ical substance satisfying all of the fol- the new chemical substance above 1 lowing low environmental release and microgram per cubic meter maximum low human exposure eligibility cri- annual average concentration, cal- teria: culated using the formula: (i) Consumers and the general popu- (kg/day of release after treatment) multi- lation. For exposure of consumers and plied by (number of release days per year)

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multiplied by (9.68 × 10¥6) micrograms per ment Control Office (DCO) (7407M), Of- cubic meter. fice of Pollution Prevention and (v) Land or groundwater. For releases Toxics, Environmental Protection to land or groundwater, no releases to Agency, 1200 Pennsylvania Ave., NW., groundwater, to land, or to a landfill Washington, DC 20460–0001 or submitted unless the manufacturer has dem- via courier to the Environmental Pro- onstrated to EPA’s satisfaction in a tection Agency, OPPT Document Con- notice under paragraph (e) of this sec- trol Office (DCO), EPA East Bldg., 1201 tion that the new substance has neg- Constitution Ave., NW., Rm. 6428, ligible groundwater migration poten- Washington, DC 20004. tial. (B) All other notices and related sup- (d) Chemical substances that cannot be port documents may be submitted on manufactured under this exemption. A paper on or before April 6, 2011. All new chemical substance cannot be paper-based notices must be generated manufactured under this section, not- using e-PMN reporting software and be withstanding satisfaction of the cri- completed through the finalization terion of paragraphs (c)(1) or (c)(2) of step of the software, and e-PMN soft- this section, if EPA determines, in ac- ware must be used to print EPA Form cordance with paragraph (g) of this sec- 7710–25 for submission to EPA. Paper tion, that the substance, any reason- notices must be submitted either via ably anticipated metabolites, environ- U.S. mail to the Document Control Of- mental transformation products, or by- fice (DCO) (7407M), Office of Pollution products of the substance, or any rea- Prevention and Toxics, Environmental sonably anticipated impurities in the Protection Agency, 1200 Pennsylvania substance may cause, under antici- Ave., NW., Washington, DC 20460–0001 pated conditions of manufacture, proc- or submitted via courier to the Envi- essing, distribution in commerce, use, ronmental Protection Agency, OPPT or disposal of the new chemical sub- Document Control Office (DCO), EPA stance: East Bldg., 1201 Constitution Ave., (1) Serious acute (lethal or sublethal) NW., Rm. 6428, Washington, DC 20004. effects. (ii) Submissions on optical disc—(A) (2) Serious chronic (including car- Notices may be submitted as electronic cinogenic and teratogenic) effects. files on optical disc on or before April (3) Significant environmental effects. 6, 2012. Notices submitted as electronic (e) Exemption notice. (1) A manufac- files on optical disc must be generated turer applying for an exemption under using e-PMN reporting software and be either paragraph (c)(1) or (c)(2) of this completed through the finalization section must submit an exemption no- step of the software. Optical discs con- tice to the EPA at least 30 days before taining electronic notices must be sub- manufacture of the new chemical submitted by courier to the Environ- stance begins. Unless allowed as de- mental Protection Agency, OPPT Doc- scribed by § 723.50(e)(1)(i), (e)(1)(ii), or ument Control Office (DCO), EPA East (e)(1)(iii), exemption notices and modi- Bldg., 1201 Constitution Ave., NW., Rm. fications must be submitted to EPA on 6428, Washington, DC 20004. EPA Form No. 7710–25 via EPA’s Cen- (B) Persons submitting on optical tral Data Exchange (CDX) using EPA- disc must still complete and submit on provided e-PMN reporting software in paper the Certification and Submitter the manner set forth in this paragraph. Identification sections of EPA Form Support documents related to these no- 7710–25 accompanying the optical disc. tices must also be submitted to EPA (iii) Submissions via CDX—(A) On or via CDX using e-PMN software in the after April 6, 2010, notices, and any re- manner set forth in this paragraph. See lated support documents, may be sub- 40 CFR 720.40(a)(2)(iv) for information mitted electronically to EPA via CDX. on how to obtain e-PMN software. Prior to submission to EPA via CDX, (i) Paper-based submissions—(A) Such notices must be generated and com- notices, and any support documents re- pleted on EPA Form 7710–25 using e- lated to these notices, submitted before PMN reporting software. April 6, 2010 must be submitted on (B) On or after April 6, 2012, all no- paper either via U.S. mail to the Docu- tices must be generated and completed

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on EPA Form 7710–25 using e-PMN re- estimated maximum amount to be porting software and submitted elec- manufactured during any 12–month pe- tronically, along with any support doc- riod during the first 3 years of produc- uments related to these notices, to tion. EPA via CDX. (vii) Description of intended cat- (iv) Support documents for notices egories of use (§ 720.45(f)). that are submitted before April 6, 2010 (viii) For manufacturer-controlled must be submitted on paper either via sites, the manufacturer shall supply U.S. mail to the Document Control Of- identity of manufacturing sites, proc- fice (DCO) (7407M), Office of Pollution ess descriptions, and worker exposure Prevention and Toxics, Environmental and environmental release information Protection Agency, 1200 Pennsylvania (§ 720.45(g)); for sites not controlled by Ave., NW., Washington, DC 20460–0001 the manufacturer, processing and use or submitted via courier to the Envi- operation descriptions, estimated num- ronmental Protection Agency, OPPT ber of processing and use sites, and Document Control Office (DCO), EPA worker exposure/environmental release East Bldg., 1201 Constitution Ave., information (§ 720.45(h)). A manufac- NW., Rm. 6428, Washington, DC 20004. turer applying for an exemption under (2) The notice shall contain the infor- paragraph (c)(1) of this section need mation described below, pursuant to not provide information on worker ex- the referenced provisions of § 720.45. posure and environmental release ref- (i) Manufacturer identity. erenced in paragraphs (e)(2)(viii) of this (ii) Chemical identity (§ 720.45(a)). section if such information is not (iii) Impurities (§ 720.45(b)). known or not readily available to the (iv) Known synonyms or trade names manufacturer. To assist in reporting (§ 720.45(c)). this information, manufacturers may (v) Byproducts (§ 720.45(d)). obtain a copy of EPA’s Guidance for (vi) Production volume (§ 720.45(e)). Reporting Occupational Exposure and (A) Manufacturers submitting an ex- Environmental Release Information emption application under paragraph under 40 CFR 723.50, available from the (c)(1) of this section will be assumed to Environmental Assistance Division at be manufacturing at an annual produc- the address listed in paragraph (e)(1) of tion volume of 10,000 kilograms. Manu- this section. Where worker exposure facturers who intend to manufacture and environmental release information an exempted substance at annual vol- is not supplied by the manufacturer, umes of less than 10,000 kilograms and EPA will generally apply ‘‘bounding es- wish EPA to conduct its risk assessment based upon such lesser annual timates’’ (i.e., exposure estimates high- production level rather than a 10,000– er than those incurred by persons in kilograms level, may so specify by the population with the highest expo- writing the lesser annual production sure) to account for uncertainties in volume in the appropriate box on the actual exposure and release scenarios. PMN form and marking the adjacent (ix) Type and category of notice. The binding option box. Manufacturers who manufacturer must clearly indicate on opt to specify annual production levels the first page of the PMN form that the below 10,000 kilograms and who mark submission is a ‘‘TSCA section 5(h)(4) the production volume binding option exemption notice,’’ and must indicate box shall not manufacture more than whether the notice is being submitted the specific annual amount of the ex- under paragraph (c)(1) or (c)(2) of this empted substance unless a new exemp- section. Manufacturers of chemical tion notice for a higher (up to 10,000 substances that qualify for an exemp- kgs) manufacturing volume is sub- tion under both paragraph (c)(1) and mitted and approved pursuant to this (c)(2) of this section may apply for ei- section. ther exemption, but not both. (B) Manufacturers submitting an ex- (x) Test data (§ 720.50). emption under paragraph (c)(2) of this (xi) Certification. In addition to the section shall list the estimated max- certifications required in EPA form imum amount to be manufactured dur- 7710–25, the following certifications ing the first year of production and the shall be included in notices under this

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section. The manufacturer must certify tion under this section was previously that: approved may apply for an exemption (A) The manufacturer intends to under paragraph (c)(1) or (c)(2) of this manufacture or import the new chem- section; however, EPA will not approve ical substance for commercial pur- any subsequent exemption application poses, other than in small quantities under paragraph (c)(1) of this section solely for research and development, unless it can determine that the poten- under the terms of this section. tial human exposure to, and environ- (B) The manufacturer is familiar mental release of, the new chemical with the terms of this section and will substance at the higher aggregate pro- comply with those terms. duction volume will not present an un- (C) The new chemical substance for reasonable risk of injury to human which the notice is submitted meets all health or the environment. applicable exemption conditions. (2)(i) If EPA proposes to deny an ex- (D) For substances manufactured emption application for a substance for under paragraph (c)(1) of this section, which another manufacturer currently the manufacturer intends to commence holds an exemption, and that proposed manufacture of the exempted sub- denial is based exclusively on the cu- stance for commercial purposes within mulative human exposure or environ- 1 year of the date of the expiration of mental release of the substance which the 30–day review period. precludes the EPA from determining (xii) Sanitized copy of notice. (A) The that the subsequent applicant’s activi- manufacturer must make all claims of ties will not present an unreasonable confidentiality in accordance with risk of injury to human health or the paragraph (l) of this section. If any in- environment, the EPA will notify the formation is claimed confidential, the first exemption holder that it must, manufacturer must submit a second within 21 days of its receipt of EPA’s copy of the notice, with all information notice, either: claimed as confidential deleted, in ac- (A) Provide a new certification that cordance with paragraph (l)(3) of this it has commenced, or that it will com- section. mence, manufacture of the new chem- (B) If the manufacturer does not pro- ical substance under this section with- vide the second copy, the submission in 1 year of the expiration of its exemp- will be considered incomplete. tion review period; or (3) Incomplete notices. If EPA receives (B) Withdraw its exemption for the a submission which does not include all new chemical substance. of the information required under this (ii) If the first exemption holder does paragraph (e) of this section, the sub- not respond to the EPA’s notice under mission will be determined to be in- paragraph (f)(2)(i) of this section with- complete by EPA. When a submission in the prescribed time period, EPA for a new chemical substance has been shall issue a notice of ineligibility to determined to be incomplete, a manu- the first exemption holder under the facturer reapplying for an exemption provisions of paragraph (h)(2) of this for the new chemical substance must section. submit a new exemption notice con- (g) Review period. (1) EPA will review taining all the information required the notice submitted under paragraph under this paragraph (e) of this section (e) of this section to determine whether including a certification page con- manufacture of the new chemical sub- taining an original dated signature; stance is eligible for the exemption. partial submissions sent to EPA to The review period will end 30 days after supplement notices declared incom- receipt of the notice by the TSCA Doc- plete will not be accepted. Photocopied ument Control Officer. To provide addi- pages from previously submitted ex- tional time to address any unresolved emption forms will be accepted pro- issues concerning an exemption appli- vided that the certifications page con- cation, the exemption applicant may, tains an original dated signature. at any time during the review period, (f) Multiple exemption holders. (1) A request a suspension of the review pe- manufacturer who intends to manufac- riod pursuant to the provisions of ture a substance for which an exemp- § 720.75(b) of this chapter.

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(2) Upon expiration of the 30–day re- determination under paragraph view period, if EPA has taken no ac- (h)(2)(iii) of this section. tion, the manufacturer may consider (ii) A manufacturer who has received its exemption approved and begin to notice under paragraph (h)(2)(i)(A) of manufacture the new chemical sub- this section may submit, within 15 stance under the terms described in its days of receipt of written notification, notice and in this section. detailed objections to the determina- (h) Notice of ineligibility—(1) During tion or an explanation of its diligence the review period. If the EPA determines and good faith efforts in attempting to during the review period that manufac- comply with the terms of this section. ture of the new chemical substance (iii) The Assistant Administrator will does not meet the terms of this section consider any objections or explanation or that there are issues concerning tox- submitted under paragraph (h)(2)(ii) of icity or exposure that require further this section and will make a final de- review which cannot be accomplished termination. The Assistant Adminis- within the 30–day review period, EPA trator will notify the manufacturer of will notify the manufacturer by tele- the final determination by telephone phone that the substance is not eligi- within 15 days of receipt of the objec- ble. This telephone notification will tions or explanation, and subsequently subsequently be confirmed by certified by certified letter. letter that identifies the reasons for (iv) If the Assistant Administrator the ineligibility determination. The determines that manufacture of the new chemical substance meets the manufacturer may not begin manufac- terms of this section, the manufacturer ture of the new chemical substance may continue or resume manufacture, without complying with section 5(a)(1) processing, distribution in commerce, of the Act or submitting a new notice and use in accordance with the terms under paragraph (e) of this section that of this section. satisfies EPA’s concerns. (v) If the Assistant Administrator de- (2) After the review period. (i)(A) If at termines that manufacture of the new any time after the review period speci- chemical substance does not meet the fied in paragraph (g) of this section the terms of this section and that the man- Assistant Administrator for the Office ufacturer did not act with due dili- of Prevention, Pesticides, and Toxic gence and in good faith to meet the Substances (‘‘the Assistant Adminis- terms of this section, the manufacturer trator’’) makes a preliminary deter- must cease any continuing manufac- mination that manufacture of the new ture, processing, distribution in com- chemical substance does not meet the merce, and use of the new chemical terms of this section, the Assistant Ad- substance within 7 days of the written ministrator will notify the manufac- notification under paragraph (h)(2)(iii) turer by certified letter that EPA be- of this section. The manufacturer may lieves that the new chemical substance not resume manufacture, processing, does not meet the terms of the section. distribution in commerce, and use of (B) The manufacturer may continue the new chemical substance until it to manufacture, process, distribute in submits a notice under section 5(a)(1) commerce, and use the substance after of the Act and part 720 of this chapter receiving the notice under paragraph and the notice review period has ended. (h)(2)(i)(A) of this section if the manu- (vi) If the Assistant Administrator facturer was manufacturing, proc- determines that manufacture of the essing, distributing in commerce, or new chemical substance does not meet using the substance at the time of the the terms of this section and that the notification and if the manufacturer manufacturer acted with due diligence submits objections or an explanation and in good faith to meet the terms of under paragraph (h)(2)(ii) of this sec- this section, the manufacturer may tion. Manufacturers not manufac- continue manufacture, processing, dis- turing, processing, distributing in com- tribution in commerce, and use of the merce, or using the substance at the new chemical substance if: time of the notification may not begin (A) It was actually manufacturing, manufacture until EPA makes its final processing, distributing in commerce,

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or using the chemical substance at the scribed in the exemption notice under time it received the notification speci- paragraph (e) of this section. fied in paragraph (h)(2)(i)(A) of this (2) Where the manufacturer lists a section. specific physical form in which the new (B) It submits a notice on the new chemical substance will be manufac- chemical substance under section tured, processed, and/or used, the man- 5(a)(1) of the Act and part 720 of this ufacturer must continue manufac- chapter within 15 days of receipt of the turing, processing, and/or using the written notification under paragraph new chemical substance in either the (h)(2)(iii) of this section. Such manu- same physical form described in the facture, processing, distribution in notice under paragraph (e), or in a commerce, and use may continue un- physical form which will not increase less EPA takes action under section the human exposure to or environ- 5(e) or 5(f) of the Act. mental release of the new chemical (3) Action under this paragraph does substance over those exposures or re- not preclude action under sections 7, leases resulting from the specified 15, 16, or 17 of the Act. physical form (e.g., a manufacturer (i) Additional information. If the man- which specifies that the new chemical ufacturer of a new chemical substance substance will be produced in a non- under the terms of this exemption ob- volatile liquid form generally may not tains test data or other information in- change to a respirable powder form). dicating that the new chemical sub- (3) The annual production volume of stance may not qualify under terms of chemical substances manufactured this section, the manufacturer must under paragraph (c)(1) of this section submit these data or information to for which the manufacturer designated EPA within 15 working days of receipt a binding annual production volume of the information. If, during the no- pursuant to paragraph (e)(2)(vi) of this tice review period specified in para- section must not exceed that des- graph (g) of this section, the submitter ignated volume. obtains possession, control, or knowl- (4) Any person who manufactures a edge of new information that materi- new chemical substance under para- ally adds to, changes, or otherwise graph (c)(1) or (c)(2) of this section makes significantly more complete the must comply with the provisions of information included in the notice, the submitter must send that information this section, including submission of a to the address listed on the notice form new notice under paragraph (e) of this within 10 days of receiving the new in- section, before: formation, but no later than 5 days be- (i) Manufacturing the new chemical fore the end of the notice review pe- substance at a site that was not ap- riod. The new submission must clearly proved in a previous exemption notice identify the submitter and the exemp- for the substance, except as provided in tion notice to which the new informa- paragraph (j)(6) of this section. tion is related. If the new information (ii) Manufacturing the new chemical becomes available during the last 5 substance for a use that was not ap- days of the notice review period, the proved in a previous exemption notice submitter must immediately inform its for the substance. EPA contact for that notice by tele- (iii) Manufacturing the new chemical phone. substance without employing the (j) Changes in manufacturing site, use, human exposure and environmental re- human exposure and environmental release controls approved in a previous lease controls, and certain manufacturing exemption notice for the substance. volumes. (1) Except as provided in para- (iv) Manufacturing the new chemical graph (j)(6) of this section, chemical substance in a physical form different substances manufactured under this than that physical form approved in a section must be manufactured at the previous exemption notice for the sub- site or sites described, for the uses de- stance and which form may increase scribed, and under the human exposure the human exposure to, or environ- and environmental release controls de- mental release of, the new chemical

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substance over those exposures or re- native concentration level approved by leases resulting from the physical form the Agency in writing or under the pro- approved in the previous notice. cedures described in paragraph (v) Manufacturing the chemical sub- (c)(2)(iii) of this section, using the stance in annual production volumes water concentration calculation meth- above any volume designated by the od described at §§ 721.90 and 721.91. manufacturer as binding under para- (ii) The manufacturer shall notify graph (e)(2)(vi) of this section in a pre- EPA of any new manufacturing site no vious exemption notice for the sub- later than 30 days after the commence- stance. ment of manufacture of the new chem- (5) In an exemption notice informing ical substance under the exemption at EPA of a change in site, use, or worker the new manufacturing site as follows: protection, or environmental release (A) The notification must contain controls, the manufacturer is not re- the EPA-designated exemption number quired to provide all of the same infor- to which the notification applies, man- mation submitted to EPA in a previous ufacturer identity, the street address exemption notice for that chemical of the new manufacturing site, the date substance. The new exemption notice, on which manufacture commenced at however, must indicate the identity of the new site, the name and telephone the new chemical substance; the manu- number of a technical contact at the facturer’s name; the name and tele- new site, any claim of confidentiality, phone number of a technical contact; and a statement that the notification and location of the new site, new work- is an amendment to the original exer protection or environmental release emption application under the terms of controls, and new use information. The this section. notice must also include the EPA-des- (B) The notification may be sub- ignated exemption number assigned to mitted on EPA form 7710–56 ‘‘Notice of the previous notice and a new certifi- Commencement of Manufacture;’’ how- cation by the manufacturer, as de- ever, the manufacturer must add the scribed in paragraph (e)(2)(xi) of this statement required under paragraph section. (j)(6)(ii)(A) of this section that the no- (6)(i) A manufacturer may, without tification is an amendment to the submitting a new notice, manufacture original exemption. the new chemical substance at a site (C) The notification must contain an not listed in its exemption application original signature of an authorized offi- under the following conditions: cial of the manufacturer. (A) the magnitude, frequency, and (k) Customer notification. (1) Manufac- duration of exposure of individual turers of new chemical substances de- workers to the new chemical substance scribed in paragraphs (c)(1) and (c)(2) of at the new manufacturing site is equal this section must notify processors and to, or less than, the magnitude, fre- industrial users that the substance can quency, and duration of exposure of the be used only for the uses specified in individual workers to the new chemical the exemption notice at paragraph (e) substance at the manufacturing site of this section. The manufacturer must for which the EPA performed its origi- also inform processors and industrial nal risk-assessment pursuant to the users of any controls specified in the original exemption notice; and exemption notice. The manufacturer (B) Either (1) at the new manufac- may notify processors and industrial turing site, the manufacturer does not users by means of a container labeling release to surface waters any of the system, written notification, or any new chemical substance, or any waste other method that adequately informs streams containing the new chemical them of use restrictions or controls. substance; or (2) at the new manufac- (2) A manufacturer of a new chemical turing site, the manufacturer main- substance described in paragraph (c)(2) tains surface water concentrations of of this section may distribute the the chemical substance, resulting from chemical substance only to other per- direct or indirect discharges from the sons who agree in writing to not fur- manufacturing site, at or below 1 part ther distribute the substance until it per billion, or at or below an alter- has been reacted, incorporated into an

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article, or otherwise rendered into a treated in accordance with the proce- physical form or state in which envi- dures in part 2 of this chapter. Any in- ronmental releases and human expo- formation not claimed confidential at sures above the eligibility criteria in the time of submission may be made paragraph (c)(2) of this section are not available to the public without further likely to occur. notice. (3) If the manufacturer learns that a (2)(i) Any person who asserts a claim direct or indirect customer is proc- of confidentiality for chemical identity essing or using the new substance in under this paragraph (l) must provide a violation of use restrictions or without generic chemical name that is only as imposing prescribed worker protection generic as necessary to protect the or environmental release controls, the confidential chemical identity of the manufacturer must cease distribution particular chemical substance. The of the substance to the customer or the name should reveal the specific chem- customer’s supplier immediately un- ical identity to the maximum extent less the manufacturer is able to docu- possible. ment each of the following: (ii) The generic name provided by the (i) That the manufacturer has, within manufacturer will be subject to EPA 5 working days, notified the customer review and approval in accordance with in writing that the customer has failed the procedures specified in § 720.85(b)(6) to comply with the conditions specified of this chapter. The generic name pro- in this section and the exemption no- vided by the submitter or an alter- tice under paragraph (e) of this section. native selected by EPA under these (ii) That, within 15 working days of procedures will be placed on a public notifying the customer of the non- list of substances exempt under this compliance, the manufacturer received section. from the customer, in writing, a state- (3) If any information is claimed con- ment of assurance that the customer is fidential, the manufacturer must sub- aware of the terms of this section and mit a second copy of the notice with all the exemption notice and will comply with those terms. information claimed as confidential de- (4) If, after receiving a statement of leted. EPA will place the second copy assurance from a customer under para- in the public file. graph (k)(3)(ii) of this section, the (m) Exemptions granted under super- manufacturer obtains knowledge that seded regulations. Manufacturers hold- the customer has again failed to coming exemptions granted under the su- ply with any of the conditions specified perseded requirements of this section in this section or the exemption notice, (as in effect on May 26, 1995) shall ei- the manufacturer shall cease supplying ther continue to comply with those re- the new chemical substance to that quirements (including the production customer and shall report the failure volume limit) or apply for a new ex- to comply to EPA within 15 days of ob- emption pursuant to this section. EPA taining this knowledge. Within 30 days will not accept requests to amend ex- of its receipt of the report, EPA will emptions granted under the superseded notify the manufacturer whether, and requirements; manufacturers wishing under what conditions, distribution of to amend such exemptions must sub- the chemical substance to the cus- mit a new exemption under paragraph tomer may resume. (e) of this section. If a new exemption (l) Confidentiality. (1) If the manufac- for a new chemical substance is grant- turer submits information to EPA ed under this exemption to the manu- under this section which the manufac- facturer holding an exemption under turer claims to be confidential business the superseded requirements, the ex- information, the manufacturer must emption under the superseded require- clearly identify the information at the ments for such substance shall be void. time of submission to EPA by brack- (n) Recordkeeping. (1) A manufacturer eting, circling, or underlining it and of a new chemical substance under stamping it with ‘‘CONFIDENTIAL’’ or paragraph (c) of this section must some other appropriate designation. maintain the records described in this Any information so identified will be paragraph at the manufacturing site or

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site of importation for a period of 5 premanufacture notice requirements of years after their preparation. section 5(a)(1)(A) of the Toxic Sub- (2) The records must include the fol- stances Control Act (15 U.S.C. lowing to demonstrate compliance with 2604(a)(1)(A)) for the manufacture and this section: processing of new chemical substances (i) Records of annual production vol- used in or for the manufacture or proc- ume and import volume. essing of instant photographic and (ii) Records documenting compliance peel-apart film articles. This section with the applicable requirements and does not apply to microorganisms sub- restrictions of paragraphs (c), (e), (f), ject to part 725 of this chapter. (h), (i), (j), and (k) of this section. (2) To manufacture a new chemical (3) Any person who manufactures a substance under the terms of this ex- new chemical substance under the emption, a manufacturer of instant terms of this section must, upon request of a duly designated representa- photographic or peel-apart film arti- tive of EPA, permit such person at all cles must: reasonable times to have access to and (i) Submit an exemption notice when to copy records kept under paragraph manufacture begins under paragraph (i) (n)(2) of this section. of this section. (4) The manufacturer must submit (ii) Comply with certain require- the records listed in paragraph (n)(2) of ments to limit exposure to the new this section to EPA upon request. Man- chemical substance under paragraphs ufacturers must provide these records (e), (f), (g), and (h) of this section. within 15 working days of receipt of (iii) Comply with all recordkeeping such request. requirements under paragraph (j) of (o) Compliance. (1) Failure to comply this section. with any provision of this section is a (b) Definitions. (1) Act means the violation of section 15 of the Act (15 Toxic Substances Control Act (15 U.S.C. 2614). U.S.C. 2601 et seq.). (2) Submitting materially misleading (2) An article is a manufactured item or false information in connection with (i) which is formed to a specific shape the requirements of any provision of or design during manufacture, (ii) this section is a violation of this section and therefore a violation of sec- which has end use function(s) depend- tion 15 of the Act (15 U.S.C. 2614). ent in whole or in part upon its shape (3) Violators may be subject to the or design during end use, and (iii) civil and criminal penalties in section which has either no change of chemical 16 of the Act (15 U.S.C. 2615) for each composition during its end use or only violation. those changes of composition which (4) EPA may seek to enjoin the man- have no commercial purpose separate ufacture or processing of a chemical from that of the article and that may substance in violation of this section, occur as described in § 710.2 of this or act to seize any chemical substance chapter except that fluids and particles manufactured or processed in violation are not considered articles regardless of this section, or take other action of shape or design. under the authority of section 7 of the (3) The terms byproduct, EPA, impuri- Act (15 U.S.C. 2606) or section 17 of the ties, person, and site have the same Act (15 U.S.C. 1616). meanings as in § 710.3 of this chapter. [60 FR 16346, Mar. 29, 1995, as amended at 60 (4) The term category of chemical sub- FR 34465, July 3, 1995; 62 FR 17932, April 11, stances has the same meaning as in sec- 1997; 64 FR 31989, June 15, 1999; 71 FR 33642, tion 26(c)(2) of the Act (15 U.S.C. 2625). June 12, 2006; 75 FR 787, Jan. 6, 2010] (5) The terms chemical substance, dis- § 723.175 Chemical substances used in tribute in commerce, distribution in com- or for the manufacture or proc- merce, environment, manufacture, new essing of instant photographic and chemical substance, and process have the peel-apart film articles. same meanings as in section 3 of the (a) Purpose and scope. (1) This section Act (15 U.S.C. 2602). grants an exemption from the

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(6) Director of the Office of Pollution (i) Data from a formal or informal Prevention and Toxics means the Direc- study, test, experiment, recorded ob- tor of the EPA Office of Pollution Pre- servation, monitoring, or measure- vention and Toxics or any EPA em- ment. ployee designated by the Office Direc- (ii) Information concerning the ob- tor to carry out the Office Director’s jectives, experimental methods and functions under this section. materials, protocols, results, data anal- (7) The term exemption category yses (including risk assessments), and means a category of chemical sub- conclusions from a study, test, experi- stances for which a person(s) has ap- ment, recorded observation, moni- plied for or been granted an exemption toring, or measurement. under section 5(h)(4) of the Act (15 (15) Used in or for the manufacturing or U.S.C. 2604). processing of an instant photographic or (8) The term instant photographic film peel-apart film article, when used to de- article means a self-developing photo- scribe activities involving a new chem- graphic film article designed so that ical substance, means the new chem- all the chemical substances contained ical substance (i) is included in the ar- in the article, including the chemical ticle, or (ii) is an intermediate to a substances required to process the film, chemical substance included in the ar- remain sealed during distribution and ticle or is one of a series of intermedi- use. ates used to manufacture a chemical substance included in the article. (9) Intermediate means any chemical (16) Wet mixture means a water or or- substance which is consumed in whole ganic solvent-based suspension, solu- or in part in a chemical reaction(s) tion, dispersion, or emulsion used in used for the intentional manufacture of the manufacture of an instant photo- another chemical substance. graphic or peel-apart film article. (10) Known to or reasonably ascertain- (c) Exemption category. The exemption able means all information in a per- category includes new chemical sub- son’s possession or control, plus all instances used in or for the manufacture formation that a reasonable person or processing of instant photographic similarly situated might be expected to or peel-apart film articles which are possess, control, or know, our could ob- manufactured and processed under the tain without unreasonable burden or terms of this section. cost. (d) Applicability. This exemption ap- (11) The term peel-apart film article plies only to manufacturers of instant means a self-developing photographic photographic or peel-apart film arti- film article consisting of a positive cles who: image receiving sheet, a light sensitive (1) Manufacture the new chemical negative sheet, and a sealed reagent substances used in or for the manufac- pod containing a developer reagent and ture or processing of the instant photo- designed so that all the chemical sub- graphic or peel-apart film articles. stances required to develop or process (2) Limit manufacture and processing the film will not remain sealed within of a new chemical substance to the the article during and after the devel- site(s) listed in the exemption notice opment of the film. for that new chemical substance sub- (12) Photographic article means any mitted under paragraph (i) of this sec- article which will become a component tion. of an instant photographic or peel- (3) Comply with the requirements of apart film article. paragraphs (e), (f), (g), (h), and (j) of (13) Special production area means a this section. demarcated area within which all man- (4) Do not distribute in commerce or ufacturing, processing, and use of a use a peel-apart film article containing new chemical substance takes place, a new chemical substance until submis- except as provided in paragraph (f) of sion of a premanufacture notice under this section, in accordance with the re- section 5(a)(1)(A) of the Act (15 U.S.C. quirements of paragraph (e) of this sec- 2604) and until the review period for the tion. notice has ended without EPA action (14) Test data means: to prevent distribution or use.

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(e) Conditions of manufacture and proc- (3) Monitoring—(i) When to monitor. essing in the special production area. All (A) When suitable sampling and ana- manufacturing, processing, and use op- lytic methods exist, periodic moni- erations involving the new chemical toring in accordance with this para- substance must be performed in a spe- graph must be done to ensure compli- cial production area under the condi- ance with the exposure limits of para- tions set forth in this paragraph until graphs (e)(1) and (2)(ii) of this section. the new chemical substance has been (B) When suitable sampling and ana- incorporated into a wet mixture, pho- lytic methods do not exist, compliance tographic article, or instant photo- with the exposure limits of paragraph graphic or peel-apart film article. (e)(1) and the requirements of para- (1) Exposure limits. In the special pro- graph (e)(10) of this section must be de- duction area, the ambient air con- termined by an evaluation of moni- centration of the new chemical sub- toring data developed for a surrogate stance during manufacture, processing, chemical substance possessing com- and use cannot exceed an 8-hour time parable physical-chemical properties weighted average (TWA) of 10 ppm for under similar manufacturing and proc- gases and vapors and 50 μg/m3 for par- essing conditions. ticulates, with an allowable TWA ex- (ii) Monitoring methods. A suitable air cursion of 50 percent above those con- sampling method must permit personal centrations for a duration of 30 min- or fixed location sampling by conven- utes or less. tional collection methods. A suitable analytic method must have adequate (2) Respiratory protection—(i) Res- sensitivity for the volume of sample pirator requirement. Except as specified available and be specific for the new in paragraph (e)(2)(ii) of this section, chemical substance being monitored. If each person in the special production chemical-specific monitoring methods area must wear an appropriate res- are not available, nonspecific methods piratory protection device to protect may be used if the concentration of the against dusts, fumes, vapors, and other new chemical substance is assumed to airborne contaminants, as described in be the total concentration of chemical 29 CFR 1910.134. Selection of an appro- substances monitored. priate respirator must be made accord- (iii) Monitoring frequency. (A) When ing to the guidance of American Na- suitable air sampling and analytical tional Standard Practices for Res- procedures are available, monitoring piratory Protection Z88.2–1969 and the must be done in each special produc- NIOSH Certified Equipment List, U.S. tion area during the first three 8-hour Department of Health and Human work shifts involving the manufacture Services, NIOSH publication No. 80–144. or processing of each new chemical (ii) Waiver of respirator requirement. substance. Thereafter, monitoring Employees are not required to wear must be done in each special produc- respirators if monitoring information tion area for at least one 8-hour period collected and analyzed in accordance per month, during a production run in with paragraph (e)(3) of this section which the new chemical substance is demonstrates that the ambient 8-hour manufactured or processed. Samples TWA concentration of the new chem- must be of such frequency and pattern ical substance in the area is less than as to represent with reasonable accu- 1 ppm for gases and vapors and 5 μg/m3 racy the mean level and maximum 30- for particulates with an allowable TWA minute level of employee exposure dur- excursion of 50 percent above these ing an 8-hour work shift. In monitoring concentrations for a duration of 30 for an 8-hour work shift or the equiva- minutes or less. lent, samples must be collected peri- (iii) Quantitative fit test. Each res- odically or continuously for the dura- pirator must be issued to a specific in- tion of the 8-hour work shift. Samples dividual for personal use. A quan- must be taken during a period which is titative fit test must be performed for likely to represent the maximum em- each respirator before its first use by ployee exposure. that person in a special production (B) If the manufacturer demonstrates area. compliance with the exposure limits

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for 3 consecutive months, further mon- graph (e)(1) or (e)(2)(ii) of this section. itoring of the identical process must be Written procedures and all materials performed only every 6 months there- necessary for responding to emergency after, unless there is a significant situations must be immediately acces- change in the process, process design, sible to all employees in a special pro- or equipment. If there is such a change, duction area. Any spill or unantici- the manufacturer must begin moni- pated emission must be controlled by toring again according to the schedule specially trained personnel using the in paragraph (e)(3)(iii)(A) of this sec- equipment and protective clothing de- tion. scribed in paragraph (e)(6) of this sec- (iv) Location of monitoring. Air sam- tion. ples must be taken so as to ensure that (6) Personal protection devices. All the samples adequately represent the workers engaged in the manufacture ambient air concentration of a new and processing of a new chemical sub- chemical substance present in each stance in the special production area worker’s breathing zone. must wear suitable protective clothing (4) Engineering controls and exposure or equipment, such as chemical-resist- safeguards. Engineering controls such ant coveralls, protective eyewear, and as, but not limited to, isolation, enclo- gloves. sure, local exhaust ventilation, and (7) Caution signs. Each special produc- dust collection must be used to ensure tion area must be clearly posted with compliance with the exposure limits signs identifying the area as a special prescribed in paragraphs (e)(1) or production area where new chemical (e)(2)(ii) of this section. substances are manufactured and proc- (5) Training, hygiene, and work prac- essed under controlled conditions. Each tices—(i) Training. No employee may sign must clearly restrict entry into enter a special production area before the special production area to qualified the completion of a training program. personnel who are properly trained and The training program must be adapted equipped with appropriate personal ex- to the individual circumstances of the posure safeguards. manufacturer and must address: The (8) Removal for storage or transpor- known physical-chemical and toxi- tation. A new chemical substance that cological properties of the chemical is not incorporated into a wet mixture, substances handled in the area; proce- photographic article, or instant photo- dures for using and maintaining res- graphic or peel-apart film article may pirators and other personal safeguards; be removed from the special production applicable principles of hygiene; spe- area for purposes of storage between cial handling procedures designed to operational steps or for purposes of limit personal exposure to, and inad- transportation to another special pro- vertent release of, chemical sub- duction area. Such storage or transpor- stances; and procedures for responding tation must be conducted in a manner to emergencies or spills. that limits worker and environmental (ii) Hygiene. Appropriate standards of exposure through the use of engineer- hygiene must be observed by all em- ing controls, training, hygiene, work ployees handling a new chemical sub- practices, and personal protective de- stance in manufacturing, processing, or vices appropriate to the chemical sub- transfer operations. The manufacturer stance in question. must provide appropriate facilities for (9) Labeling. (i) Any new chemical employee changing and wash-up. Food, substance removed from a special pro- beverages, tobacco products, and cos- duction area or stored or transported metics must not be allowed in special between operational steps must be production areas. clearly labeled. The label must show (iii) Work practices. Operating proce- the identity of the new chemical sub- dures such as those related to chemical stance or an appropriate identification weighing and filtering, or the charging, code, a statement of any known haz- discharging and clean-up of process ards associated with it, a list of special equipment, must be designed and con- handling instructions, first aid infor- ducted to ensure compliance with the mation, spill control directions, and exposure limits prescribed in para- where applicable, the appropriate U.S.

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Department of Transportation nota- appropriate protective clothing or tions. equipment such as gloves, eye protec- (ii) No label is required if the new tion, and, where necessary, respirators chemical substance has been incor- or chemically imprevious clothing. porated into a photographic article, or (3) Personal protection devices. All if it is contained in a sealed reaction workers engaged in the processing of a vessel or pipeline, or if it has been in- wet mixture containing a new chemical corporated into an instant photo- substance must wear suitable protec- graphic or peel-apart film article. tive clothing or equipment such as cov- (10) Areas immediately adjacent to the eralls, protective eyewear, respirators, special production area. The ambient air and gloves. concentration of the new chemical sub- (g) Incorporation of photographic arti- stance in areas immediately adjacent cles into instant photographic and peel- to the special production area must not apart film articles. A photographic arti- exceed the exposure limit established cle may be incorporated into the in- in paragraph (e)(2)(ii) of this section stant photographic or peel-apart film for waiver of respirator protection article outside the special production within the special production area. area. The manufacturer must take Periodic monitoring in accordance measures to limit worker and environ- with paragraph (e)(3) of this section mental exposure to new chemcial sub- must be performed in immediately ad- stances during these operations using jacent areas where it is reasonable to engineering controls, training, hy- expect a risk of inhalation exposure. giene, work practices, and personal (f) Conditions of processing outside the protective devices. special production area. A wet mixture (h) Environmental release and waste may be incorporated into a photo- treatment—(1) Release to land. Process graphic article or an instant photo- waste from manufacturing and proc- graphic or peel-apart film article out- essing operations in the special produc- side the special production area under tion area that contain a new chemical the conditions listed in this paragraph: substance are considered to be haz- (1) Engineering controls and exposure safeguards. Engineering controls must ardous waste and must be handled in limit the exposure to a new chemical accordance with the requirements of substance contained in a wet mixture. parts 262 through 267 and parts 122 and (2) Training, hygiene and work prac- 124 of this chapter. tices—(i) Training. Training of employ- (2) Release to water. All wastewater or ees involved in the handling of wet discharge which contain the new mixtures containing a new chemical chemcial subtance must be appro- substance must be adapted to the indi- priately pretreated before release to a vidual circumstances of the employees’ Publicly Owned Treatment Works activities and must address: Proce- (POTW) or other receiving body of dures for using personal exposure safe- water. In the case of release to a guards, applicable principles of hy- POTW, the pretreatment must prevent giene, handling procedures designed to structural damage to, obstruction of, limit personal exposure, and proce- or interference with the operation of dures for responding to emergencies the POTW. The treatment of direct re- and spills. lease to a receiving body of water must (ii) Hygiene. Appropriate standards of be appropriate for the new chemical hygiene that limit exposure must be substance’s physical-chemical prop- observed by all employees handling wet erties and potential toxicity. mixtures that contain new chemical (3) Release to air. All process emis- substances. sions released to the air which contain (iii) Work practices. Work practices the new chemical substance must be and operating procedures must be de- vented through control devices appro- signed to limit exposure to any new priate for the new chemical substance’s chemical substance contained in wet physical-chemical properties and po- mixtures. Any spills or unanticipated tential toxicity. releases of a wet mixture must be con- (i) Exemption notice. An exemption trolled by trained personnel wearing notices must be submitted to EPA

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when manufacture of the new chemical new chemcial substance when manu- substance begins. factured under the exemption by name (1) Contents of exemption notice. The and CAS Registry Number, by class of exemption notice must include the fol- substances, or by process or source. lowing information: The notice also must estimate the (i) Manufacturer and sites. The notice maximum percent (by weight) of each must identify the manufacturer and impurity in the new chemical sub- the sites and locations where the new stance and the percent of unknown im- chemical substance and the instant purities present. photographic or peel-apart film arti- (iv) Physical-chemical properties. The cles will be manufactured and proc- notice must describe the physical- essed. chemical properties of the new chem- (ii) Chemical identification. The notice ical substance. Where specific physical- must identify the new chemical sub- chemical data are not available, rea- stance as follows: sonable estimates and the techniques (A) Class 1 substances. For chemical used to develop these estimates must substances whose composition can be be provided. represented by a definite structural (v) Byproducts. The notice must iden- disagram (Class 1 substances), the notify the name, CAS Registry number (if tice must provide the chemical name available), and the volume of each by- (preferably CAS or IUPAC nomen- product that would be manufactured clature), the molecular formula, CAS during manufacture of the new chem- Registry Number (if available), known ical substance. synonyms (including trade names), and (vi) Production volume. The notice a structural diagram. must include an estimate of the antici- (B) Class 2 substances. For chemical pated maximum annual production vol- substances that cannot be fully rep- ume. resented by a structural diagram, (Class 2 substances), the notice must (vii) Test data. The notice must in- provide the chemical name, the molec- clude all information and test data on ular formula, the CAS Registry Num- the new chemical substance’s health ber (if available), and known synonyms and environmental effects that are (including trade names). The notice known to or reasonably ascertainable must identify the immediate precur- by the manufacturer. sors and reactants by name and CAS (viii) Identity of the article. The notice Registry Number (if available). The no- must identify and describe the instant tice must include a partial or incom- photographic film article(s) or peel- plete structural diagram, if available. apart film article(s) that will contain (C) Polymers. For a polymer, the no- the new chemical substance. tice must indentify monomers and (ix) Release to water. The notice must other reactants used in the manufac- include a description of the methods ture of the polymer by chemical name used to control and treat wastewater and CAS Registry Number. The notice or discharge released to a POTW or must indicate the amount of each mon- other receiving body of water. The no- omer used (by weight percent of total tice must also identify the POTW or re- monomer); the maximum residual of ceiving body of water. each monomer present in the polymer; (x) Certification. The manufacturer and a partial or incomplete structural must certify in the notice that it is fa- diagram, if available. The notice must miliar with the terms of the exemption indicate the number average molecular and that the manufacture, processing, weight of the polymer and characterize distribution, use, and disposal of the the anticipated low molecular weight new chemical substance will comply species. The notice must include this with those terms. information for each typical average (2) Duplication of information in molecular weight composition of the premanufacture notice. If a manufac- polymer to be manufactured. turer who submits an exemption notice (iii) Impurities. The notice must iden- under this paragraph has already sub- tify the impurities that can be reason- mitted, or simultaneously submits, a ably anticipated to be present in the premanufacture notice under section

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5(a)(1)(A) of the Act for the new chem- guards, including the results of any ical substance, it may, in lieu of sub- personal exposure monitoring, the remitting the information required by sults of the quantitative fit test for the this paragraph, reference the required worker’s personal respirator, and any information to the extent it is included additional information related to the in the premanufacture notice. At a worker’s occupational exposure. minimum, the exemption notice must (iv) Treatment records. Manufacturers identify the manufacturer and the new who release treated wastewater or dis- chemical substance, and contain the charge containing a new chemical sub- certification required by paragraph stance to a POTW or other receiving (i)(1)(x) of this section. body of water must maintain records of (3) Address. The exemption notice the method of treatment. must be addressed to the Document (2) The manufacturer must make the Control Office (DCO) (7407M), Office of records listed in paragraph (j)(1) of this Pollution Prevention and Toxics section available to EPA upon written (OPPT), Environmental Protection request by the Director of the Office of Agency, 1200 Pennsylvania Ave., NW., Pollution Prevention and Toxics. The Washington, DC 20460–0001. manufacturer must provide these (j) Recordkeeping. (1) Manufacturers records within 15 working days of re- of a new chemical substance under this ceipt of this request. exemption must keep the following (k) Confidentiality. If the manufac- records for 30 years from the final date turer submits information under para- of manufacture. graph (i) or (j) of this section which it (i) Production records. Each manufac- claims to be confidential business in- turer must maintain records of the an- formation, the manufacturer must nual production volume of each new clearly identify the information at the chemical substance manufactured time of submission to the Agency by under the terms of the exemption. This bracketing, circling, or underlining it record must indicate when manufac- and stamping it with ‘‘CONFIDEN- ture of the new chemical substance TIAL’’ or some other appropriate des- began. ignation. Any information so identified (ii) Exposure monitoring records. Man- will be treated in accordance with the ufacturers must maintain an accurate procedures in part 2 of this chapter. record of all monitoring required by Any information not claimed confiden- this section. Monitoring records may tial at the time of submission will be be adapted to the individual cir- made available to the public without cumstances of the manufacturer but, further notice to the submitter. at a minimum, must contain the fol- (l) Amendment and repeal. (1) EPA lowing information: The chemical iden- may amend or repeal any term of this tity of the new chemical substance, exemption if it determines that the date of the monitoring, the actual manufacture, processing, distribution, monitoring data for each monitoring use, and disposal of new chemical sub- location and sampling, and a reference stances under the terms of the exemp- to or description of the collection and tion may present an unreasonable risk analytic techniques. If the manufac- of injury to health or the environment. turer does not monitor, the manufac- EPA also may amend this exemption to turer must maintain a record of the enlarge the exemption category or to reasons for not monitoring and the reduce the restrictions or conditions of methods used to determine compliance the exemption. with the exposure limits of paragraph (2) As required by section 5(h)(4) of (e)(1) of this section. the Act, EPA will amend or repeal the (iii) Training and exposure records. For substantive terms of an exemption each employee engaged in the manu- granted under this part only by the for- facture or processing of a new chemical mal rulemaking procedures described substance, the company must develop in section 6(c)(2) and (3) of the Act (15 and maintain a record of the worker’s U.S.C. 2605(c)). participation in required training. This (m) Prohibition of use of the exemption. record must also demonstrate the reg- The Director of the Office of Pollution ular use of personal exposure safe- Prevention and Toxics may prohibit

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the manufacture, processing, distribu- (v) Comply with the recordkeeping tion, use, or disposal of any new chem- requirements of paragraph (j) of this ical substance under the terms of this section. exemption if he or she determines that (b) Definitions. In addition to the defi- the manufacture, processing, distribu- nitions under section 3 of the Act, 15 tion in commerce, use, or disposal of U.S.C. 2602, the following definitions the new chemical substance may apply to this part. present an unreasonable risk of injury Act means the Toxic Substances Con- to health or the environment. trol Act (15 U.S.C. 2601 et seq.). (n) Enforcement. (1) A failure to com- Biopolymer means a polymer directly ply with any provision of this part is a produced by living or once-living cells violation of section 15 of the Act (15 or cellular components. U.S.C. 2614). Category of chemical substances has (2) Submitting materially misleading the same meaning as in section 26(c)(2) or false information in connection with of the Act (15 U.S.C. 2625). the requirements of any provision of Cationic polymer means a polymer this part is a violation of this regula- that contains a net positively charged tion and therefore a violation of sec- atom(s) or associated groups of atoms tion 15 of the Act (15 U.S.C. 2614). covalently linked to its polymer mol- (3) Violators may be subject to the ecule. civil and criminal penalties in section Chemical substance, Director, EPA, im- 16 of the Act (15 U.S.C. 2615) for each porter, impurity, Inventory, known to or violation. reasonably ascertainable, manufacture, (4) EPA may seek to enjoin the man- manufacturer, mixture, new chemical, ufacture of a new chemical substance person, possession or control, process and in violation of this exemption or act to test data have the same meanings as in seize any chemical substances manu- § 720.3 of this chapter. factured in violation of the exemption Equivalent weight of a functional group under the authority of section 17 of the means the ratio of the molecular Act (15 U.S.C. 2616). weight to the number of occurrences of [47 FR 24317, June 4, 1982, as amended at 53 that functional group in the molecule. FR 12523, Apr. 15, 1988; 60 FR 34465, July 3, It is the weight of substance that con- 1995; 62 FR 17932, April 11, 1997; 68 FR 906, tains one formula-weight of the func- Jan. 7, 2003; 71 FR 33642, June 12, 2006] tional group. Fluorotelomers means the products of § 723.250 Polymers. telomerization, which is the reaction of (a) Purpose and scope. (1) This section a telogen (such as pentafluoroethyl io- grants an exemption from certain of dide) with an ethylenic compound the premanufacture notice require- (such as tetrafluoroethylene) to form ments of section 5(a)(1)(A) of the Toxic low molecular weight polymeric com- Substances Control Act (15 U.S.C. pounds, which contain an array of satu- 2604(a)(1)(A)) for the manufacture of rated carbon atoms covalently bonded certain polymers. This section does not to each other (C-C bonds) and to fluo- apply to microorganisms subject to rine atoms (C-F bonds). This array is part 725 of this chapter. predominantly a straight chain, and (2) To manufacture a new chemical depending on the telogen used produces substance under the terms of this sec- a compound having an even number of tion, a manufacturer must: carbon atoms. However, the carbon (i) Determine that the substance chain length of the fluorotelomer var- meets the definition of polymer in ies widely. The perfluoroalkyl groups paragraph (b) of this section. formed by this process are usually, but (ii) Determine that the substance is do not have to be, connected to the not specifically excluded by paragraph polymer through a functionalized (d) of this section. ethylene group as indicated by the fol- (iii) Ensure that the substance meets lowing structural diagram: (Rf-CH2CH2- the exemption criteria of paragraph (e) Anything). of this section. Internal monomer unit means a mon- (iv) Submit a report as required omer unit that is covalently bonded to under paragraph (f) of this section. at least two other molecules. Internal

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monomer units of polymer molecules ple weight majority of molecules con- are chemically derived from monomer taining at least 3 monomer units which molecules that have formed covalent are covalently bound to at least one bonds between two or more other mon- other monomer unit or other reactant omer molecules or other reactants. and which consists of less than a sim- Monomer means a chemical substance ple weight majority of molecules of the that is capable of forming covalent same molecular weight. Such mol- bonds with two or more like or unlike ecules must be distributed over a range molecules under the conditions of the of molecular weights wherein dif- relevant polymer-forming reaction ferences in the molecular weight are used for the particular process. primarily attributable to differences in Monomer Unit means the reacted form the number of monomer units. In the of the monomer in a polymer. context of this definition, sequence Number-average molecular weight means that the monomer units under means the arithmetic average (mean) consideration are covalently bound to of the molecular weight of all mol- one another and form a continuous ecules in a polymer. string within the molecule, uninter- Oligomer means a polymer molecule rupted by units other than monomer consisting of only a few monomer units units. (dimer, trimer, tetramer) Polymer molecule means a molecule Other reactant means a molecule which contains a sequence of at least 3 linked to one or more sequences of monomer units which are covalently monomer units but which, under the bound to at least one other monomer relevant reaction conditions used for unit or other reactant. the particular process, cannot become Reactant means a chemical substance a repeating unit in the polymer struc- that is used intentionally in the manu- ture. facture of a polymer to become chemi- Perfluoroalkyl carboxylate (PFAC) cally a part of the polymer composi- means a group of saturated carbon tion. atoms covalently bonded to each other Reactive functional group means an in a linear, branched, or cyclic array atom or associated group of atoms in a and covalently bonded to a carbonyl chemical substance that is intended or moiety and where all carbon-hydrogen can reasonably be anticipated to under- (C-H) bonds have been replaced with go further chemical reaction. carbon-fluorine (C-F) bonds. The car- Reasonably anticipated means that a bonyl moiety is also covalently bonded knowledgeable person would expect a to a hetero atom, typically, but not given physical or chemical composition necessarily oxygen (O) or nitrogen (N). or characteristic to occur based on Perfluoroalkyl sulfonate (PFAS) means such factors as the nature of the pre- a group of saturated carbon atoms cursors used to manufacture the poly- covalently bonded to each other in a mer, the type of reaction, the type of linear, branched, or cyclic array and manufacturing process, the products covalently bonded to a sulfonyl moiety produced in polymerization, the in- and where all carbon - hydrogen (C-H) tended uses of the substance, or associ- bonds have been replaced with carbon - ated use conditions. fluorine (C-F) bonds. The sulfonyl moi- (c) Applicability. This section applies ety is also covalently bonded to a to manufacturers of new chemical sub- hetero atom, typically, but not nec- stances that otherwise must submit a essarily oxygen (O) or nitrogen (N). premanufacture notice to EPA under Polyester means a chemical substance § 720.22 of this chapter. New substances that meets the definition of polymer are eligible for exemption under this and whose polymer molecules contain section if they meet the definition of at least two carboxylic acid ester link- ‘‘polymer’’ in paragraph (b) of this sec- ages, at least one of which links inter- tion, and the criteria in paragraph (e) nal monomer units together. of this section, and if they are not ex- Polymer means a chemical substance cluded from the exemption under para- consisting of molecules characterized graph (d) of this section. by the sequence of one or more types of (d) Polymers that cannot be manufac- monomer units and comprising a sim- tured under this section—(1) Cationic

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polymers. A polymer cannot be manu- hydrolysis, attack by solvents, heat, factured under this section if the poly- light, or microbial action. mer is a cationic polymer as defined (4) Polymers manufactured or imported under paragraph (b) of this section or if from monomers and reactants not on the the polymer is reasonably anticipated TSCA Chemical Substance Inventory. A to become a cationic polymer in a nat- polymer cannot be manufactured under ural aquatic environment (e.g., rivers, this section if the polymer being manu- lakes) unless: factured or imported is prepared from (i) The polymer is a solid material monomers and/or other reactants (that that is not soluble or dispersible in are either charged to the reaction ves- water and will be used only in the solid sel or incorporated in the polymer at phase (e.g., polymers that will be used levels of greater than 2 weight percent) as ion exchange beads), or that are not already included on the (ii) The combined (total) functional TSCA Chemical Substance Inventory group equivalent weight of cationic or manufactured under an applicable groups in the polymer is equal to or TSCA section 5 exemption. greater than 5,000. (5) Water absorbing polymers with num- (2) Elemental limitations. (i) A polymer ber average molecular weight (MW) 10,000 manufactured under this section must and greater. A polymer cannot be manufactured under this section if the contain as an integral part of its com- polymer being manufactured or im- position at least two of the atomic ele- ported is a water absorbing polymer ments carbon, hydrogen, nitrogen, oxy- and has a number average MW greater gen, silicon, and sulfur. than or equal to 10,000 daltons. For pur- (ii) A polymer cannot be manufac- poses of this section, a water-absorbing tured under this section if it contains polymer is a polymeric substance that as an integral part of its composition, is capable of absorbing its weight of except as impurities, any elements water. other than the following: (6) Polymers which contain certain (A) The elements listed in paragraph perfluoroalkyl moieties consisting of a (d)(2)(i) of this section. CF3- or longer chain length. Except as (B) Sodium, magnesium, aluminum, provided in paragraph (d)(6)(i), after potassium, calcium, chlorine, bromine, February 26, 2010, a polymer cannot be and iodine as the monatomic manufactured under this section if the = = = = = counterions Na , Mg 2, Al 3, K , Ca 2, polymer contains as an integral part of ¥ ¥ ¥ Cl , Br , or I . its composition, except as impurities, (C) Fluorine, chlorine, bromine, and one or more of the following iodine covalently bound to carbon. perfluoroalkyl moieties consisting of a (D) Less than 0.20 weight percent of CF3- or longer chain length: any combination of the atomic ele- Perfluoroalkyl sulfonates (PFAS), ments lithium, boron, phosphorus, tita- perfluoroalkyl carboxylates (PFAC), nium, manganese, iron, nickel, copper, fluorotelomers, or perfluoroalkyl zinc, tin, and zirconium. moieties that are covalently bound to (3) Polymers which degrade, decompose, either a carbon or sulfur atom where or depolymerize. A polymer cannot be the carbon or sulfur atom is an inte- manufactured under this section if the gral part of the polymer molecule. polymer is designed or is reasonably (i) Any polymer that has been manu- anticipated to substantially degrade, factured previously in full compliance decompose, or depolymerize, including with the requirements of this section those polymers that could substan- prior to February 26, 2010 may no tially decompose after manufacture longer be manufactured under this sec- and use, even though they are not actu- tion after January 27, 2012. ally intended to do so. For the purposes (ii) [Reserved] of this section, degradation, decompo- (e) Exemption criteria. To be manufac- sition, or depolymerization mean those tured under this section, the polymer types of chemical change that convert must meet one of the following cri- a polymeric substance into simpler, teria: smaller substances, through processes (1) Polymers with number average MW including but not limited to oxidation, greater than or equal to 1,000 and less

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than 10,000 daltons (and oligomer content (B) The polymer has a combined less than 10 percent below MW 500 and (total) reactive group equivalent less than 25 percent below MW 1,000). (i) weight greater than or equal to 1,000 The polymer must have a number aver- for the following reactive functional age MW greater than or equal to 1,000 groups: acidhalides; acid anhydrides; and less than 10,000 daltons and contain aldehydes, hemiacetals; less than 10 percent oligomeric mate- methylolamides,- amines or,- ureas; rial below MW 500 and less than 25 per- alkoxysilanes with alkoxy greater than cent oligomeric material below MW C2-alkoxysilanes; allyl ethers; con- 1,000. jugated olefins; cyanates; epoxides; (ii) The polymer cannot contain reac- imines; or unsubstituted positions tive functional groups unless it meets ortho or para to phenolic hydroxyl; or one of the following criteria: (C) If any reactive functional groups (A) The polymer contains only the not included in paragraph (e)(1)(ii)(A) following reactive functional groups: and (B) of this section are present, the carboxylic acid groups, aliphatic combined (total) reactive group equiva- hydroxyl groups, unconjugated olefinic lent weight, including any groups list- groups that are considered ‘‘ordi- ed in paragraph (e)(1)(ii)(B), is greater nary,’’(i.e., not specially activated ei- than or equal to 5,000. ther by being part of a larger func- (2) Polymers with number average MW tional group, such as a vinyl ether, or greater than or equal to 10,000 (and by other activating influences, e.g., oligomer content less than 2 percent below strongly electron-withdrawing sulfone MW 500 and less than 5 percent below group with which the olefinic groups MW 1,000) . The polymer must have a interact), butenedioic acid groups, number average MW greater than or those conjugated olefinic groups con- equal to 10,000 daltons and contain less tained in naturally-occurring fats, oils, than 2 percent oligomeric material and carboxylic acids, blocked below MW 500 and less than 5 percent isocyanates (including ketoxime- oligomeric material below MW 1000. blocked isocyanates), thiols, (3) Polyester polymers. The polymer is unconjugated nitrile groups, and a polyester as defined in paragraph (b) halogens (except that reactive halogen- of this section and is manufactured containing groups such as benzylic or solely from one or more of the allylichalides cannot be included). reactants in the following table 1:

TABLE 1—LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE

Reactant CAS No.

Monobasic Acids and Natural Oils Benzoic acid ...... 65–85–0 Canola oil ...... 120962–03–0 Coconut oil ...... 8001–31–8* Corn oil ...... 8001–30–7* Cottonseed oil ...... 8001–29–4* Dodecanoic acid ...... 143–07–7 Fats and glyceridic oils, anchovy ...... 128952–11–4* Fats and glyceridic oils, babassu ...... 91078–92–1* Fats and glyceridic oils, herring ...... 68153–06–0* Fats and glyceridic oils, menhaden ...... 8002–50–4* Fats and glyceridic oils, sardine ...... 93334–41–9* Fats and glyceridic oils, oiticica ...... 8016–35–1* Fatty acids,C16-18 and C18-unsatd...... 67701–08–0* Fatty acids, castor-oil ...... 61789–44–4* Fatty acids, coco ...... 61788–47–4* Fatty acids, dehydrated castor-oil ...... 61789–45–5* Fatty acids, linseed oil ...... 68424–45–3* Fatty acids, safflower oil. Fatty acids, soya ...... 68308–53–2* Fatty acids, sunflower oil ...... 84625–38–7* Fatty acids, sunflower-oil, conjugated ...... 68953–27–5* Fatty acids, tall-oil ...... 61790–12–3* Fatty acids, tall-oil, conjugated*. Fatty acids, vegetable oil ...... 61788–66–7* Glycerides, C16-18 and C18-unsatd...... 67701–30–8* Heptanoic acid ...... 111–14–8 Hexanoic acid ...... 142–62–1

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TABLE 1—LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE—Continued

Reactant CAS No.

Hexanoic acid, 3,3,5-trimethyl- ...... 3302–10–1 Linseed oil ...... 8001–26–1* Linseed oil, oxidized ...... 68649–95–6* Nonanoic acid ...... 112–05–0 Oils, Cannabis*. Oils, palm kernel ...... 8023–79–8* Oils, perilla ...... 68132–21–8* Oils, walnut ...... 8024–09–7 Safflower oil ...... 8001–23–8* Soybean oil ...... 8001–22–7* Sunflower oil ...... 8001–21–6* Tung oil ...... 8001–20–5* Di and Tri Basic Acids:. 1,2-Benzenedicarboxylic acid ...... 88–99–3 1,3-Benzenedicarboxylic acid ...... 121–91–5 1,3-Benzenedicarboxylic acid, dimethyl ester ...... 1459–93–4 1,4-Benzenedicarboxylic acid ...... 100–21–0 1,4-Benzenedicarboxylic acid, diethyl ester ...... 636–09–9 1,4-Benzenedicarboxylic acid, dimethyl ester ...... 120–61–6 1,2,4-Benzenetricarboxylic acid ...... 528–44–9 Butanedioic acid ...... 110–15–6 Butanedioic acid, diethyl ester ...... 123–25–1 Butanedioic acid, dimethyl ester ...... 106–65–0 2-Butenedioic acid (E)– ...... 110–17–8 Decanedioic acid ...... 111–20–6 Decanedioic acid, diethyl ester ...... 110–40–7 Decanedioic acid, dimethyl ester ...... 106–79–6 Dodecanedioic acid ...... 693–23–2 Fatty acids, C18-unsatd., dimers ...... 61788–89–4* Heptanedioic acid ...... 111–16–0 Heptanedioic acid, dimethyl ester ...... 1732–08–7 Hexanedioic acid ...... 124–04–9 Hexanedioic acid, dimethyl ester ...... 627–93–0 Hexanedioic acid, diethyl ester ...... 141–28–6 Nonanedioic acid ...... 123–99–9 Nonanedioic acid, dimethyl ester ...... 1732–10–1 Nonanedioic acid, diethyl ester ...... 624–17–9 Octanedioic acid ...... (505–48–6) Octanedioic acid, dimethyl ester ...... 1732–09–8 Pentanedioic acid ...... (110–94–1) Pentanedioic acid, dimethyl ester ...... 1119–40–0 Pentanedioic acid, diethyl ester ...... 818–38–2 Undecanedioic acid ...... 1852–04–6 Polyols 1,3-Butanediol ...... 107–88–0 1,4-Butanediol ...... 110–63–4 1,4-Cyclohexanedimethanol ...... 105–08–8 1,2-Ethanediol ...... 107–21–1 Ethanol, 2,2′-oxybis- ...... 111–46–6 1,6-Hexanediol ...... 629–11–8 1,3-Pentanediol, 2,2,4-trimethyl- ...... 144–19–4 1,2-Propanediol, ...... 57–55–6 1,3-Propanediol, 2,2-bis(hydroxymethyl)- ...... 115–77–5 1,3-Propanediol, 2,2-dimethyl- ...... 126–30–7 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)- ...... 77–99–6 1,3-Propanediol, 2-(hydroxymethyl)-2-methyl- ...... 77–85–0 1,3-propanediol, 2-methyl ...... 2163–42–0 1,2,3-Propanetriol ...... 56–81–5 1,2,3-Propanetriol, homopolymer ...... 25618–55–7 2-Propen-1-ol, polymer with ethenylbenzene ...... 25119-62–4 Modifiers Acetic acid, 2,2′-oxybis- ...... 110–99–6 1-Butanol ...... 71–36–3** Cyclohexanol ...... 108–93–0 Cyclohexanol, 4,4′-(1-methylethylidene)bis- ...... 80–04–6 Ethanol, 2-(2-butoxyethoxy)- ...... 112–34–5 1-Hexanol ...... 111–27–3 Methanol, hydrolysis products with trichlorohexylsilane and trichlorophenylsilane ...... 72318–84–4* 1-Phenanthrenemethanol, tetradecahydro-1,4a-dimethyl-7-(1-methylethyl)- ...... 13393–93–6 Phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2,2′- [(1-methylethylidene)bis(4,1- 25036-25–3 phenyleneoxymethylene)] bis[oxirane].

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TABLE 1—LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE—Continued

Reactant CAS No.

Siloxanes and Silicones, di-Me, di-Ph, polymers with Ph silsesquioxanes, methoxy-terminated ...... 68440–65–3* Siloxanes and Silicones, di-Me, methoxy Ph, polymers with Ph silsesquioxanes, methoxy-terminated ...... 68957–04–0* Siloxanes and Silicones, Me Ph, methoxy Ph, polymers with Ph silsesquioxanes, methoxy- and Ph-ter- 168957–06–2* minated. Silsesquioxanes, Ph Pr ...... 168037–90–1* * Chemical substance of unknown or variable composition,complex reaction products, and biological materials (UVCB). The CAS Registry Numbers for UVCB substances are not used in CHEMICAL ABSTRACTS and its indexes. ** These substances may not be used in a substance manufactured from fumaric or maleic acid because of potential risks associated with esters, which may be formed by reaction of these reactants.

(f) Exemption report for polymers manu- necessary), to demonstrate compliance factured under the terms of this section. with this paragraph. Reactants that in- For substances exempt under para- troduce into the polymer elements, graphs (e)(1), (e)(2), and (e)(3) of this properties, or functional groups that section a report of manufacture or im- would render the polymer ineligible for port must be submitted (postmarked) the exemption are not allowed at any by January 31 of the year subsequent level. to initial manufacture. The notice (2) A representative structural dia- must include: gram, if possible. (1) Manufacturer’s name. This includes (h) Certification. To manufacture a the name and address of the manufac- substance under the terms of this sec- turer and the name and telephone num- tion, a manufacturer must as of the ber of a technical contact. date of first manufacture, make the (2) Number of substances manufactured. following certification statements and Number of substances manufactured. maintain them in accordance with The manufacturer must identify the paragraph (j) of this section: number of polymers manufactured under terms of the exemption for the (1) The substance is manufactured or first time in the year preceding the no- imported for a commercial purpose tice. other than for research and develop- (g) Chemical identity information. For ment. substances exempt under paragraph (e) (2) All information in the certifi- of this section the manufacturer must cation is truthful. to the extent known to or reasonably (3) The new chemical substance ascertainable by the manufacturer meets the definition of a polymer, is identify the following and maintain the not specifically excluded from the ex- records in accordance with paragraph emption in paragraph (d) of this sec- (j) of this section: tion, and meets the conditions of the (1) A specific chemical name and CAS exemption in paragraph (e) of this sec- Registry Number (or EPA assigned Ac- tion. cession Number) for each ‘‘reactant,’’ (i) Exemptions granted under super- as that term is defined in paragraph (b) seded regulations. Manufacturers grant- of this section, used at any weight in ed exemptions under the superseded re- the manufacture of the polymer. For quirements of § 723.250 (as in effect on purposes of determining chemical iden- May 26, 1995) shall either continue to tity, the manufacturer may determine comply with those requirements or fol- whether a reactant is used at greater low all procedural and recordkeeping than two weight percent according to requirements pursuant to this section. either the weight of the reactant If an exemption holder continues to charged to the reaction vessel or the follow the superseded regulations, the weight of the chemically combined (in- Notice of Commencement requirements corporated) reactant in the polymer. apply and the exempt polymer will Manufacturers who choose the ‘‘incor- continue to be listed on the Inventory porated’’ method must have analytical with exclusion criteria and exemption data, or theoretical calculations (if it category restrictions on residual mon- can be documented that an analytical omer/reactant and low molecular determination cannot be made or is not weight species content limitations.

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(j) Recordkeeping. (1) A manufacturer (viii) The certification statements as of a new polymer under paragraphs (e) required under paragraph (h) of this of this section, must retain the records section. described in this paragraph at the man- (3) The manufacturer must submit ufacturing site for a period of 5 years the records listed in paragraph (j)(2) of from the date of commencement of this section to EPA upon written re- manufacture or import. quest by EPA. The manufacturer must (2) The records must include the fol- provide these records within 15 work- lowing to demonstrate compliance with ing days of receipt of this request. In the terms of this section: addition, any person who manufactures a new chemical substance under the (i) Chemical identity information as terms of this section, upon request of required in paragraph (g) of this sec- EPA, must permit such person at all tion. reasonable times to have access to and (ii) Information to demonstrate that to copy these records. the new polymer is not specifically ex- (k) Submission of information. Infor- cluded from the exemption. mation submitted to EPA under this (iii) Records of production volume for section must be sent in writing to: the first 3 years of manufacture and TSCA Document Control Officer, (7407), the date of commencement of manufac- Office of Pollution Prevention and ture. Toxics, Environmental Protection (iv) Information to demonstrate that Agency, 1200 Pennsylvania Ave., NW., the new polymer meets the exemption Washington, DC 20460. criteria in paragraphs (e)(1), (e)(2), or (l) Compliance. (1) A person who man- (e)(3) of this section. ufactures or imports a new chemical (v) Analytical data, or theoretical substance and fails to comply with any calculations (if it can be documented provision of this section is in violation that an analytical determination can- of section 15 of the Act (15 U.S.C. 2614). not be made or is not necessary), to (2) Using for commercial purposes a demonstrate that the polymer meets chemical substance or mixture which a the number-average MW exemption cri- person knew or had reason to know was teria in paragraphs (e)(1) or (e)(2) of manufactured, processed, or distrib- this section. The analytical tests may uted in commerce in violation of sec- include gel permeation chroma- tion 5 of the Act is a violation of sec- tography (GPC).vapor pressure osmom- tion 15 of the Act (15 U.S.C. 2614). etry (VPO), or other such tests which (3) Failure or refusal to establish and will demonstrate that the polymer maintain records or to permit access to meets the number-average MW cri- or copying of records, as required by this section and section 11 of the Act, terion. is a violation of section 15 of the Act (vi) Analytical data, or theoretical (15 U.S.C. 2614). calculations (if it can be documented (4) Failure or refusal to permit entry that an analytical determination can- or inspection as required by section 11 not be made or is not necessary), to of the Act is a violation of section 15 of demonstrate that the polymer meets the Act (15 U.S.C. 2614). the criteria in paragraphs (e)(1) or (5) Violators may be subject to the (e)(2) of this section, meets the low MW civil and criminal penalties in section content criteria in paragraphs (e)(1) or 16 of the Act (15 U.S.C. 2615) for each (e)(2) of this section. violation. Persons who submit materi- (vii) If applicable, analytical data, or ally misleading or false information in theoretical calculations (if it can be connection with the requirements of documented that an analytical deter- any provision of this section may be mination cannot be made or is not nec- subject to penalties calculated as if essary) required in paragraph (g) of they never filed their notices. this section for determining monomers (6) EPA may seek to enjoin the man- or reactants charged to the reaction ufacture or processing of a chemical vessel at greater than 2 weight percent substance in violation of this section but incorporated at 2 weight percent or or act to seize any chemical substance less in the manufactured polymer. manufactured or processed in violation

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of this section or take other actions 725.50 EPA review. under the authority of section 7 of the 725.54 Suspension of the review period. Act (15 U.S.C. 2606) or section 17 of the 725.56 Extension of the review period. 725.60 Withdrawal of submission by the sub- Act (15 U.S.C. 2616). mitter. (m) Inspections. EPA will conduct in- 725.65 Recordkeeping. spections under section 11 of the Act to 725.67 Applications to exempt new micro- assure compliance with section 5 and organisms from this part. this section, to verify that information 725.70 Compliance. submitted to EPA under this section is 725.75 Inspections. true and correct, and to audit data sub- Subpart C—Confidentiality and Public mitted to EPA under this section. Access to Information (n) Confidentiality. If a manufacturer submits information to EPA under this 725.80 General provisions for confidentiality section which the manufacturer claims claims. to be confidential business informa- 725.85 Microorganism identity. tion, the manufacturer must clearly 725.88 Uses of a microorganism. 725.92 Data from health and safety studies identify the information at the time of of microorganisms. submission to EPA by bracketing, cir- 725.94 Substantiation requirements. cling, or underlining it and stamping it 725.95 Public file. with ‘‘CONFIDENTIAL’’ or some other appropriate designation. Any informa- Subpart D—Microbial Commercial tion so identified will be treated in ac- Activities Notification Requirements cordance with the procedures in 40 CFR 725.100 Scope and purpose. part 2. Any information not claimed 725.105 Persons who must report. confidential at the time of submission 725.110 Persons not subject to this subpart. may be made available to the public 725.150 Procedural requirements for this without further notice. subpart. 725.155 Information to be included in the [60 FR 16332, Mar. 29, 1995, as amended at 62 MCAN. FR 17932, April 11, 1997; 75 FR 4305, Jan. 27, 725.160 Submission of health and environ- 2010] mental effects data. 725.170 EPA review of the MCAN. PART 725—REPORTING REQUIRE- 725.190 Notice of commencement of manu- MENTS AND REVIEW PROCESSES facture or import. FOR MICROORGANISMS Subpart E—Exemptions for Research and Development Activities Subpart A—General Provisions and Applicability 725.200 Scope and purpose. 725.205 Persons who may report under this Sec. subpart. 725.1 Scope and purpose. 725.232 Activities subject to the jurisdiction 725.3 Definitions. of other Federal programs or agencies. 725.8 Coverage of this part. 725.234 Activities conducted inside a struc- 725.12 Identification of microorganisms for ture. Inventory and other listing purposes. 725.235 Conditions of exemption for activi- 725.15 Determining applicability when ties conducted inside a structure. microorganism identity or use is con- 725.238 Activities conducted outside a struc- fidential or uncertain. ture. 725.17 Consultation with EPA. 725.239 Use of specific microorganisms in activities conducted outside a structure. Subpart B—Administrative Procedures 725.250 Procedural requirements for the TERA. 725.20 Scope and purpose. 725.255 Information to be included in the 725.25 General administrative requirements. TERA. 725.27 Submissions. 725.260 Submission of health and environ- 725.28 Notice that submission is not re- mental effects data. quired. 725.270 EPA review of the TERA. 725.29 EPA acknowledgement of receipt of 725.288 Revocation or modification of TERA submission. approval. 725.32 Errors in the submission. 725.33 Incomplete submissions. Subpart F—Exemptions for Test Marketing 725.36 New information. 725.40 Notice in the FEDERAL REGISTER. 725.300 Scope and purpose.

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725.305 Persons who may apply under this Subpart A—General Provisions subpart. and Applicability 725.350 Procedural requirements for this subpart. § 725.1 Scope and purpose. 725.355 Information to be included in the TME application. (a) This part establishes all reporting 725.370 EPA review of the TME application. requirements under section 5 of TSCA for manufacturers, importers, and Subpart G—General Exemptions for New processors of microorganisms subject Microorganisms to TSCA jurisdiction for commercial purposes, including research and devel- 725.400 Scope and purpose. opment for commercial purposes. New 725.420 Recipient microorganisms. microorganisms for which manufactur- 725.421 Introduced genetic material. ers and importers are required to re- 725.422 Physical containment and control port under section 5(a)(1)(A) of TSCA technologies. are those that are intergeneric. In ad- 725.424 Requirements for the Tier I exemp- dition, under section 5(a)(1)(B) of tion. TSCA, manufacturers, importers, and 725.426 Applicability of the Tier I exemp- processors may be required to report tion. for any microorganism that EPA deter- 725.428 Requirements for the Tier II exemp- mines by rule is being manufactured, tion. imported, or processed for a significant 725.450 Procedural requirements for the Tier new use. II exemption. (b) Any manufacturer, importer, or 725.455 Information to be included in the Tier II exemption request. processor required to report under sec- 725.470 EPA review of the Tier II exemption tion 5 of TSCA (see § 725.100 for new request. microorganisms and § 725.900 for significant new uses) must file a Microbial Subparts H–K [Reserved] Commercial Activity Notice (MCAN) with EPA, unless the activity is eligi- Subpart L—Additional Procedures for Re- ble for a specific exemption as de- porting on Significant New Uses of scribed in this part. The general proce- Microorganisms dures for filing MCANs are described in subpart D of this part. The exemptions 725.900 Scope and purpose. from the requirement to file a MCAN 725.910 Persons excluded from reporting sig- are for certain kinds of contained ac- nificant new uses. tivities (see §§ 725.424 and 725.428), test 725.912 Exemptions. marketing activities (see § 725.300), and 725.920 Exports and imports. research and development activities 725.950 Additional recordkeeping require- described in paragraph (c) of this sec- ments. tion. 725.975 EPA approval of alternative control (c) Any manufacturer, importer, or measures. processor required to file a MCAN for 725.980 Expedited procedures for issuing sig- research and development (R&D) ac- nificant new use rules for microorganisms subject to section 5(e) orders. tivities may instead file a TSCA Exper- 725.984 Modification or revocation of cer- imental Release Application (TERA) tain notification requirements. for a specific test (see § 725.250). A TERA is not required for certain R&D Subpart M—Significant New Uses for activities; however a TERA exemption Specific Microorganisms does not extend beyond the research and development stage, to general 725.1000 Scope. commercial use of the microorganism, 725.1075 Burkholderia cepacia complex. for which compliance with MCAN re- AUTHORITY: 15 U.S.C. 2604, 2607, 2613, and quirements is required. The TERA ex- 2625. emptions are for R&D activities subject to other Federal agencies or pro- SOURCE: 62 FR 17932, April 11, 1997, unless grams (see § 725.232), certain kinds of otherwise noted. contained R&D activities (see § 725.234), and R&D activities using certain listed microorganisms (see § 725.238).

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(d) New microorganisms will be ological, or other studies of a micro- added to the Inventory established organism or microbial mixture, and under section 8 of TSCA once a MCAN any test performed under the Act. has been received, the MCAN review Microorganism identity is always part period has expired, and EPA receives a of a health and safety study of a micro- Notice of Commencement (NOC) indi- organism. cating that manufacture or importa- (1) It is intended that the term tion has actually begun. New micro- ‘‘health and safety study of a microorganisms approved for use under a organism’’ be interpreted broadly. Not TERA will not be added to the Inven- only is information which arises as a tory until a MCAN has been received, result of a formal, disciplined study in- the MCAN review period has expired, cluded, but other information relating and EPA has received an NOC. to the effects of a microorganism or microbial mixture on health or the en- § 725.3 Definitions. vironment is also included. Any data Definitions in section 3 of the Act (15 that bear on the effects of a microorga- U.S.C. 2602), as well as definitions con- nism on health or the environment tained in §§ 704.3, 720.3, and 721.3 of this would be included. chapter, apply to this part unless oth- (2) Examples include: erwise specified in this section. In addi- (i) Tests for ecological or other envi- tion, the following definitions apply to ronmental effects on invertebrates, this part: fish, or other animals, and plants, in- Consolidated microbial commercial ac- cluding: Acute toxicity tests, chronic tivity notice or consolidated MCAN toxicity tests, critical life stage tests, means any MCAN submitted to EPA behavioral tests, algal growth tests, that covers more than one microorga- seed germination tests, plant growth or nism (each being assigned a separate damage tests, microbial function tests, MCAN number by EPA) as a result of a bioconcentration or bioaccumulation prenotice agreement with EPA. tests, and model ecosystem (micro- Containment and/or inactivation con- cosm) studies. trols means any combination of engineering, mechanical, procedural, or bi- (ii) Long- and short-term tests of mu- ological controls designed and operated tagenicity, carcinogenicity, or to restrict environmental release of teratogenicity; dermatoxicity; cumu- viable microorganisms from a struc- lative, additive, and synergistic effects; ture. and acute, subchronic, and chronic ef- Director means the Director of the fects. EPA Office of Pollution Prevention and (iii) Assessments of human and envi- Toxics. ronmental exposure, including work- Exemption request means any applica- place exposure, and impacts of a par- tion submitted to EPA under subparts ticular microorganism or microbial E, F, or G of this part. mixture on the environment, including General commercial use means use for surveys, tests, and studies of: Survival commercial purposes other than re- and transport in air, water, and soil; search and development. ability to exchange genetic material Genome means the sum total of chro- with other microorganisms, ability to mosomal and extrachromosomal ge- colonize human or animal guts, and netic material of an isolate and any de- ability to colonize plants. scendants derived under pure culture (iv) Monitoring data, when they have conditions from that isolate. been aggregated and analyzed to meas- Health and safety study of a microorga- ure the exposure of humans or the en- nism or health and safety study means vironment to a microorganism. any study of any effect of a microorga- (v) Any assessments of risk to health nism or microbial mixture on health or and the environment resulting from the environment or on both, including the manufacture, processing, distribu- underlying data and epidemiological tion in commerce, use, or disposal of studies, studies of occupational expo- the microorganism. sure to a microorganism or microbial Inactivation means that living micro- mixture, toxicological, clinical, and ec- organisms are rendered nonviable.

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Institutional Biosafety Committee section 5(a)(1) of the Act in accordance means the committees described in the with subpart D of this part. NIH Guidelines in section IV.B.2. Microbial mixture means any combina- Intergeneric microorganism means a tion of microorganisms or microorga- microorganism that is formed by the nisms and other chemical substances, deliberate combination of genetic ma- if the combination does not occur in terial originally isolated from orga- nature and is not an article. nisms of different taxonomic genera. Microorganism means an organism (1) The term ‘‘intergeneric micro- classified, using the 5-kingdom classi- organism’’ includes a microorganism fication system of Whittacker, in the which contains a mobile genetic ele- kingdoms Monera (or Procaryotae), ment which was first identified in a Protista, Fungi, and the Chlorophyta microorganism in a genus different and the Rhodophyta of the Plantae, from the recipient microorganism. and a virus or virus-like particle. (2) The term ‘‘intergeneric micro- Mobile genetic element or MGE means organism’’ does not include a micro- an element of genetic material that organism which contains introduced has the ability to move genetic mate- genetic material consisting of only rial within and between organisms. well-characterized, non-coding regu- ‘‘Mobile genetic elements’’ include all latory regions from another genus. plasmids, viruses, transposons, inser- Introduced genetic material means ge- tion sequences, and other classes of ele- netic material that is added to, and re- ments with these general properties. mains as a component of, the genome New microorganism means a micro- of the recipient. organism not included on the Inven- Manufacture, import, or process for tory. commercial purposes means: NIH Guidelines means the National (1) To import, produce, manufacture, Institutes of Health (NIH) ‘‘Guidelines or process with the purpose of obtain- for Research Involving Recombinant ing an immediate or eventual commer- DNA Molecules’’ (July 5, 1994). cial advantage for the manufacturer, Non-coding regulatory region means a importer, or processor, and includes, segment of introduced genetic material among other things, ‘‘manufacture’’ or for which: ‘‘processing’’ of any amount of a micro- (1) The regulatory region and any in- organism or microbial mixture: serted flanking nucleotides do not code (i) For commercial distribution, infor protein, peptide, or functional ribo- cluding for test marketing. nucleic acid molecules. (ii) For use by the manufacturer, in- (2) The regulatory region solely concluding use for product research and trols the activity of other regions that development or as an intermediate. code for protein or peptide molecules (2) The term also applies to sub- or act as recognition sites for the initi- stances that are produced coinciden- ation of nucleic acid or protein syn- tally during the manufacture, proc- thesis. essing, use, or disposal of another Small quantities solely for research and microorganism or microbial mixture, development (or ‘‘small quantities sole- including byproducts that are sepa- ly for purposes of scientific experimen- rated from that other microorganism tation or analysis or research on, or or microbial mixture and impurities analysis of, such substance or another that remain in that microorganism or substance, including such research or microbial mixture. Byproducts and im- analysis for development of a product’’) purities without separate commercial means quantities of a microorganism value are nonetheless produced for the manufactured, imported, or processed purpose of obtaining a commercial ad- or proposed to be manufactured, im- vantage, since they are part of the ported, or processed solely for research manufacture or processing of a micro- and development that meet the re- organism for commercial purposes. quirements of § 725.234. Microbial commercial activity notice or Structure means a building or vessel MCAN means a notice for microorga- which effectively surrounds and en- nisms submitted to EPA pursuant to closes the microorganism and includes

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features designed to restrict the micro- nisms that are not intergeneric are organism from leaving. automatically included on the Inven- Submission means any MCAN or ex- tory. emption request submitted to EPA (c) Microorganisms not subject to this under this part. part. The following microorganisms are Technically qualified individual means not subject to this part, either because a person or persons: they are not subject to jurisdiction (1) Who, because of education, train- under the Act or are not subject to re- ing, or experience, or a combination of porting under section 5 of the Act. these factors, is capable of under- (1) Any microorganism which would standing the health and environmental be excluded from the definition of risks associated with the microorga- ‘‘chemical substance’’ in section 3 of nism which is used under his or her su- the Act and § 720.3(e) of this chapter. pervision, (2) Who is responsible for enforcing (2) Any microbial mixture as defined appropriate methods of conducting sci- in § 725.3. This exclusion applies only to entific experimentation, analysis, or a microbial mixture as a whole and not microbiological research to minimize to any microorganisms and other such risks, and chemical substances which are part of (3) Who is responsible for the safety the microbial mixture. assessments and clearances related to (3) Any microorganism that is manu- the procurement, storage, use, and dis- factured and processed solely for ex- posal of the microorganism as may be port if the following conditions are appropriate or required within the met: scope of conducting a research and de- (i) The microorganism is labeled in velopment activity. accordance with section 12(a)(1)(B) of TSCA Experimental Release Application the Act, when the microorganism is or TERA means an exemption request distributed in commerce. for a research and development activ- (ii) The manufacturer and processor ity, which is not eligible for a full ex- can document at the commencement of emption from reporting under § 725.232, manufacturing or processing that the 725.234, or 725.238, submitted to EPA in person to whom the microorganism accordance with subpart E of this part. will be distributed intends to export it Well-characterized for introduced ge- or process it solely for export as de- netic material means that the fol- fined in § 721.3 of this chapter. lowing have been determined: (1) The function of all of the products § 725.12 Identification of microorga- expressed from the structural gene(s). nisms for Inventory and other list- (2) The function of sequences that ing purposes. participate in the regulation of expression of the structural gene(s). To identify and list microorganisms (3) The presence or absence of associ- on the Inventory, both taxonomic des- ated nucleotide sequences and their as- ignations and supplemental informa- sociated functions, where associated tion will be used. The supplemental in- nucleotide sequences are those se- formation required in paragraph (b) of quences needed to move genetic mate- this section will be used to specifically rial including linkers, homopolymers, describe an individual microorganism adaptors, transposons, insertion se- on the Inventory. Submitters must quences, and restriction enzyme sites. provide the supplemental information required by paragraph (b) of this sec- § 725.8 Coverage of this part. tion to the extent necessary to enable (a) Microorganisms subject to this part. a microorganism to be accurately and Only microorganisms which are manu- unambiguously identified on the Inven- factured, imported, or processed for tory. commercial purposes, as defined in (a) Taxonomic designation. The taxo- § 725.3, are subject to the requirements nomic designation of a microorganism of this part. must be provided for the donor orga- (b) Microorganisms automatically in- nism and the recipient microorganism cluded on the Inventory. Microorga- to the level of strain, as appropriate.

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These designations must be substan- microorganism’s identity or use has tiated by a letter from a culture collec- been claimed as CBI, that portion does tion, literature references, or the re- not appear on the public version of the sults of tests conducted for the purpose Inventory, in § 725.239 or in subpart M of taxonomic classification. Upon of this part. Instead, it is contained in EPA’s request to the submitter, data a confidential version held in EPA’s supporting the taxonomic designation Confidential Business Information Cen- must be provided to EPA. The genetic ter (CBIC). The public versions contain history of the recipient microorganism generic information which masks the should be documented back to the iso- confidential business information. A late from which it was derived. person who intends to conduct an ac- (b) Supplemental information. The sup- tivity involving a microorganism or plemental information described in use whose entry is described with ge- paragraphs (b)(1) and (b)(2) of this sec- neric information will need to inquire tion is required to the extent that it of EPA whether the unreported micro- enables a microorganism to be accu- organism or use is on the confidential rately and unambiguously identified. version. (1) Phenotypic information. (2) Uncertain microorganism iden- Phenotypic information means perti- tity. The current state of scientific nent traits that result from the inter- knowledge leads to some imprecision action of a microorganism’s genotype in describing a microorganism. As the and the environment in which it is in- state of knowledge increases, EPA will tended to be used and may include in- be developing policies to determine tentionally added biochemical and whether one microorganism is equiva- physiological traits. lent to another. Persons intending to (2) Genotypic information. Genotypic conduct activities involving micro- information means the pertinent and organisms may inquire of EPA whether distinguishing genotypic characteris- the microorganisms they intend to tics of a microorganism, such as the manufacture, import, or process are identity of the introduced genetic ma- equivalent to specific microorganisms terial and the methods used to con- described on the Inventory, in § 725.239, struct the reported microorganism. or in subpart M of this part. This also may include information on (b) Requirement of bona fide intent. (1) the vector construct, the cellular loca- EPA will answer the inquiries de- tion, and the number of copies of the scribed in paragraph (a) of this section introduced genetic material. only if the Agency determines that the § 725.15 Determining applicability person has a bona fide intent to con- when microorganism identity or duct the activity for which reporting is use is confidential or uncertain. required or for which any exemption (a) Consulting EPA. Persons intending may apply. to conduct activities involving micro- (2) To establish a bona fide intent to organisms may determine their obliga- manufacture, import, or process a tions under this part by consulting the microorganism, the person who intends Inventory or the microorganisms and to manufacture, import, or process the uses specified in § 725.239 or in subpart microorganism must submit the fol- M of this part. This section establishes lowing information in writing to the procedures for EPA to assist persons in Office of Pollution Prevention and determining whether the microorga- Toxics, Document Control Officer, 7407, nism or the use is listed on the Inven- 1200 Pennsylvania Ave., NW., Wash- tory, in § 725.239 or in subpart M of this ington, DC 20460, ATTN: BIOTECH bona part. fide submission. (1) Confidential identity or use. In (i) Taxonomic designations and sup- some cases it may not be possible to di- plemental information required by rectly determine if a specific micro- § 725.12. organism is listed, because portions of (ii) A signed statement certifying that entry may contain generic infor- that the submitter intends to manufac- mation to protect confidential business ture, import, or process the microorga- information (CBI). If any portion of the nism for commercial purposes.

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(iii) A description of research and de- the Inventory, in § 725.239, or in subpart velopment activities conducted with M of this part. the microorganism to date, demonstra- (g) A disclosure to a person with a tion of the submitter’s ability to bona fide intent to manufacture, im- produce or obtain the microorganism port, or process a particular microorga- from a foreign manufacturer, and the nism that the microorganism is on the purpose for which the person will man- Inventory, in § 725.239, or in subpart M ufacture, import, or process the micro- of this part will not be considered a organism. public disclosure of confidential busi- (iv) An indication of whether a re- ness information under section 14 of lated microorganism was previously re- the Act. viewed by EPA to the extent known by (h) EPA will answer an inquiry on the submitter. whether a particular microorganism is (v) A specific description of the subject to this part within 30 days after major intended application or use of receipt of a complete submission under the microorganism. paragraph (b) of this section. (c) If an importer or processor cannot provide all the information required by § 725.17 Consultation with EPA. paragraph (b) of this section, because it Persons may consult with EPA, ei- is claimed as confidential business in- ther in writing or by telephone, about formation by its foreign manufacturer their obligations under this part. Writ- or supplier, the foreign manufacturer ten consultation is preferred. Written or supplier may supply the information inquiries should be sent to the fol- directly to EPA. lowing address: Environmental Assist- (d) EPA will review the information ance Division (7408), Office of Pollution submitted by the manufacturer, im- Prevention and Toxics, U.S. Environ- porter, or processor under this para- mental Protection Agency, 1200 Penn- graph to determine whether that per- sylvania Ave., NW., Washington, DC son has shown a bona fide intent to 20460, ATTN: Biotechnology Notice manufacture, import, or process the Consultation. Persons wishing to con- microorganism. If necessary, EPA will sult with EPA by telephone should call compare this information to the infor- (202) 554–1404; hearing impaired TDD mation requested for the confidential (202) 554–0551 or e-mail: TSCA- microorganism under § 725.85(b)(3)(iii). [email protected]. (e) In order for EPA to make a conclusive determination of the micro- Subpart B—Administrative organism’s status, the proposed manu- Procedures facturer, importer, or processor must show a bona fide intent to manufacture, § 725.20 Scope and purpose. import, or process the microorganism This subpart describes general ad- and must provide sufficient informa- ministrative procedures applicable to tion to establish identity unambig- all persons who submit MCANs and ex- uously. After sufficient information emption requests to EPA under section has been provided, EPA will inform the 5 of the Act for microorganisms. manufacturer, importer, or processor whether the microorganism is subject § 725.25 General administrative re- to this part and if so, which sections of quirements. this part apply. (a) General. (1) Each person who is (f) If the microorganism is found on subject to the notification provisions the confidential version of the Inven- of this part must complete, sign, and tory, in § 725.239 or in subpart M of this submit a MCAN or exemption request part, EPA will notify the person(s) who containing the information as required originally reported the microorganism for the appropriate submission under that another person (whose identity this part. Except as otherwise pro- will remain confidential, if so re- vided, each submission must include quested) has demonstrated a bona fide all referenced attachments. All infor- intent to manufacture, import, or proc- mation in the submission (unless cer- ess the microorganism and therefore tain attachments appear in the open was told that the microorganism is on scientific literature) must be in

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English. All information submitted tection Agency, OPPT Document Con- must be true and correct. trol Office (DCO), EPA East Bldg., 1201 (2) In addition to specific information Constitution Ave., NW., Rm. 6428, required, the submitter should submit Washington, DC 20004. all information known to or reasonably (2) Submissions on optical disc—(i) ascertainable by the submitter that MCANs and exemption requests may be would permit EPA to make a reasoned submitted as electronic files on optical evaluation of the human health and en- disc on or before April 6, 2012. MCANs vironmental effects of the microorga- and exemption requests submitted as nism and any microbial mixture or ar- electronic files on optical disc must be ticle that may contain the microorga- generated using e-PMN reporting soft- nism. ware and be completed through the fi- (b) Certification. Persons submitting nalization step of the software. Optical MCANs and exemption requests to EPA discs containing electronic notices under this part, and material related to must be submitted by courier to the their reporting obligations under this Environmental Protection Agency, part, must attach the following state- OPPT Document Control Office (DCO), ment to any information submitted to EPA East Bldg., 1201 Constitution Ave., EPA. This statement must be signed NW., Rm. 6428, Washington, DC 20004. and dated by an authorized official of (ii) Persons submitting on optical the submitter: disc must still prepare, sign, and sub- I certify that to the best of my knowledge mit on paper, the Certification state- and belief: The company named in this sub- ment in 40 CFR 725.25(b) along with mission intends to manufacture, import, or submitter identification and contact process for a commercial purpose, other than information. in small quantities solely for research and (iii) Support documents for MCANs development, the microorganism identified or exemption requests that are sub- in this submission. All information provided in this submission is complete and truthful mitted before April 6, 2010 must be sub- as of the date of submission. I am including mitted on paper either via U.S. mail to with this submission all test data in my pos- the Document Control Office (DCO) session or control and a description of all (7407M), Office of Pollution Prevention other data known to or reasonably ascertain- and Toxics, Environmental Protection able by me as required by 40 CFR 725.160 or Agency, 1200 Pennsylvania Ave., NW., 725.260. Washington, DC 20460–0001 or submitted (c) Where to submit information under via courier to the Environmental Pro- this part. MCANs and exemption re- tection Agency, OPPT Document Con- quests, and any support documents re- trol Office (DCO), EPA East Bldg., 1201 lated to these submissions, may only Constitution Ave., NW., Rm. 6428, be submitted in a manner set forth in Washington, DC 20004. this paragraph. (3) Submissions via CDX. MCANs and (1) Paper-based submissions. MCANs exemption requests, and any related and exemption requests, and any sup- support documents, may be submitted port documents related to these sub- electronically to EPA via CDX. Prior missions, may be submitted on paper to submission to EPA via CDX, notices on or before April 6, 2011. All paper- must be generated and completed on based submissions must be generated EPA Form 6300-07 using e-PMN report- using e-PMN reporting software and be ing software. completed through the finalization (d) General requirements for submission step of the software, and e-PMN soft- of data. (1) Submissions under this part ware must be used to print the bio- must include the information described technology notice submission to be in § 725.155, 725.255, 725.355, or 725.455, as sent to EPA. Paper notices must be appropriate, to the extent such infor- submitted either via U.S. mail to the mation is known to or reasonably as- Document Control Office (DCO) certainable by the submitter. (7407M), Office of Pollution Prevention (2) In accordance with § 725.160 or and Toxics, Environmental Protection 725.260, as appropriate, the submission Agency, 1200 Pennsylvania Ave., NW., must also include any test data in the Washington, DC 20460–0001 or submitted submitter’s possession or control and via courier to the Environmental Pro- descriptions of other data which are

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known to or reasonably ascertainable § 725.160. If the person does not submit by the submitter and which concern the test data, the submission is incom- the health and environmental effects of plete and EPA will follow the proce- the microorganism. dures in § 725.33. (e) Agency or joint submissions. (1) A (2) If EPA has granted the submitter manufacturer or importer may des- an exemption under section 4(c) of the ignate an agent to assist in submitting Act from the requirement to conduct the MCAN. If so, only the manufac- tests and submit data, the person may turer or importer, and not the agent, not file a MCAN or TERA until EPA signs the certification on the form. receives the test data. (2) A manufacturer or importer may (3) If EPA has granted the submitter authorize another person, (e.g., a sup- an exemption under section 4(c) of the plier or a toll manufacturer) to report Act and if another person previously some of the information required in the has submitted the test data to EPA, MCAN to EPA on its behalf. The manu- the exempted person may either sub- facturer or importer should indicate in mit the test data or provide the fol- a cover letter accompanying the MCAN lowing information as part of the no- which information will be supplied by tice: another person and identify that other (i) The name, title, and address of the person as a joint submitter where indi- person who submitted the test data to cated in their MCAN. The other person EPA. supplying information (i.e., the joint (ii) The date the test data were sub- submitter) may submit the informa- mitted to EPA. tion to EPA either in the MCAN or a (iii) A citation for the test rule. Letter of Support, except that if the (iv) A description of the exemption joint submitter is not incorporated, li- and a reference identifying it. censed, or doing business in the United (g) Microorganisms subject to a section States, the joint submitter must sub- 5(b)(4) rule. (1) If a person: mit the information to EPA in a Letter (i) Intends to manufacture or import of Support only, rather than the a microorganism which is subject to MCAN. The joint submitter must indi- the notification requirements of this cate in the MCAN or Letter of Support part and which is subject to a rule the identity of the manufacturer or im- issued under section 5(b)(4) of the Act; porter. Any person who submits the and MCAN or Letter of Support for a joint (ii) Is not required by a rule issued submission must sign and certify the under section 4 of the Act to submit MCAN or Letter of Support. test data for the microorganism before (3) If EPA receives a submission the filing of a submission, the person which does not include the information must submit to EPA data described in required, which the submitter indicates paragraph (g)(2) of this section at the that it has authorized another person time the submission is filed. to provide, the review period will not (2) Data submitted under paragraph begin until EPA receives all of the re- (g)(1) of this section must be data quired information. which the person submitting the notice (f) Microorganisms subject to a section 4 believes show that the manufacture, test rule. (1) Except as provided in para- processing, distribution in commerce, graph (f)(3) of this section, if a person use, and disposal of the microorganism, intends to manufacture or import a or any combination of such activities, new microorganism which is subject to will not present an unreasonable risk the notification requirements of this of injury to health or the environment. part, and the microorganism is subject (h) Data that need not be submitted. to a test rule promulgated under sec- Specific data requirements are listed in tion 4 of the Act before the notice is subparts D, E, F, G, and L of this part. submitted, section 5(b)(1) of the Act re- The following is a list of data that need quires the person to submit the test not be submitted under this part: data required by the testing rule with (1) Data previously submitted to the notice. The person must submit the EPA. (i) A person need not submit any data in the form and manner specified data previously submitted to EPA with in the test rule and in accordance with no claims of confidentiality if the new

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submission includes: the office or per- determine whether the microorganism son to whom the data were submitted; is subject to the requirements of this the date of submission; and, if appro- part. If EPA determines that the priate, a standard literature citation as microorganism is not subject to these specified in § 725.160(a)(3)(ii). requirements, EPA will notify the sub- (ii) For data previously submitted to mitter that section 5 of the Act does EPA with a claim of confidentiality, not prevent the manufacture, import, the person must resubmit the data or processing of the microorganism and with the new submission and any claim that the submission is not needed. of confidentiality, under § 725.80. (2) Efficacy data. This part does not § 725.29 EPA acknowledgement of re- require submission of any data related ceipt of submission. solely to product efficacy. However, in- (a) EPA will acknowledge receipt of cluding efficacy data will improve each submission by sending a letter via EPA’s ability to assess the benefits of CDX or U.S. mail to the submitter that the use of the microorganism. This identifies the number assigned to each does not exempt a person from submit- MCAN or exemption request and the ting any of the data specified in date on which the review period begins. § 725.160 or 725.260. The review period will begin on the (3) Non-U.S. exposure data. This part date the MCAN or exemption request is does not require submission of any received by the Office of Pollution Pre- data which relates only to exposure of vention and Toxics Document Control humans or the environment outside the Officer. United States. This does not exclude (b) The acknowledgement does not nonexposure data such as data on constitute a finding by EPA that the health effects (including epidemiolog- submission is in compliance with this ical studies), ecological effects, phys- part. ical and chemical properties, or environmental fate characteristics. [62 FR 17932, April 11, 1997, as amended at 75 FR 788, Jan. 6, 2010] [62 FR 17932, April 11, 1997, as amended at 75 FR 788, Jan. 6, 2010] § 725.32 Errors in the submission. § 725.27 Submissions. (a) Within 30 days of receipt of the submission, EPA may request that the Each person who is required to sub- submitter remedy errors in the submis- mit information under this part must sion. The following are examples of submit the information in the form and such errors: manner set forth in the appropriate (1) Failure to date the submission. subpart. (a) Requirements specific to MCANs (2) Typographical errors that cause are described in §§ 725.150 through data to be misleading or answers to 725.160. any questions to be unclear. (b) Requirements specific to TERAs (3) Contradictory information. are described in §§ 725.250 through (4) Ambiguous statements or infor- 725.260. mation. (c) Requirements specific to test (b) In the request to correct the sub- marketing exemptions (TMEs) are de- mission, EPA will explain the action scribed in §§ 725.350 and 725.355. which the submitter must take to cor- (d) Requirements specific to Tier I rect the submission. and Tier II exemptions for certain gen- (c) If the submitter fails to correct eral commercial uses are described in the submission within 15 days of re- §§ 725.424 through 725.470. ceipt of the request, EPA may extend (e) Additional requirements specific the review period. to significant new uses for microorganisms are described at § 725.950. § 725.33 Incomplete submissions. (a) A submission under this part is § 725.28 Notice that submission is not not complete, and the review period required. does not begin, if: When EPA receives a MCAN or ex- (1) The wrong person files the sub- emption request, EPA will review it to mission.

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(2) The submitter does not attach and the Director, or a designee, may design the certification statement as re- clare the submission incomplete within quired by § 725.25(b). 30 days after EPA obtains the addi- (3) Some or all of the information in tional information and so notify the the submission or any attachments are submitter. not in English, except for published sci- (c) The notification that a submis- entific literature. sion is incomplete under paragraph (b) (4) The submitter does not provide in- of this section will include: formation that is required by sections (1) A statement of the basis of EPA’s 5(d)(1)(B) and (C) of the Act and § 725.160 determination that the submission is or 725.260, as appropriate. incomplete. (5) The submitter does not provide in- (2) The requirements for correcting formation required by § 725.25, 725.155, the incomplete submission. 725.255, 725.355, or 725.455, as appro- (3) Information on procedures under priate, or indicate that it is not known paragraph (d) of this section for filing to or reasonably ascertainable by the objections to the determination or re- submitter. questing modification of the require- (6) The submitter has asserted con- ments for completing the submission. fidentiality claims and has failed to: (i) Submit a second copy of the sub- (d) Within 10 days after receipt of no- mission with all confidential informa- tification by EPA that a submission is tion deleted for the public file, as re- incomplete, the submitter may file quired by § 725.80(b)(2). written objections requesting that EPA (ii) Comply with the substantiation accept the submission as complete or requirements as described in § 725.94. modify the requirements necessary to (7) The submitter does not include complete the submission. any information required by section (e)(1) EPA will consider the objec- 5(b)(1) of the Act and pursuant to a rule tions filed by the submitter. The Direc- promulgated under section 4 of the Act, tor, or a designee, will determine as required by § 725.25(f). whether the submission was complete (8) The submitter does not submit or incomplete, or whether to modify data which the submitter believes show the requirements for completing the that the microorganism will not submission. EPA will notify the sub- present an unreasonable risk of injury mitter in writing of EPA’s response to health or the environment, if EPA within 10 days of receiving the objec- has listed the microorganism under tions. section 5(b)(4) of the Act, as required in (2) If the Director, or a designee, de- § 725.25(g). termines, in response to the objection, (9) For MCANs, the submitter does that the submission was complete, the not remit the fees required by review period will be deemed suspended § 700.45(b)(1) or (b)(2)(vi) of this chapter. on the date EPA declared the submis- (10) The submitter does not include sion incomplete, and will resume on an identifying number and a payment the date that the submission is de- identity number as required by clared complete. The submitter need § 700.45(e)(3) of this chapter. not correct the submission as EPA (11) The submitter does not submit originally requested. If EPA can com- the notice in the manner set forth in plete its review within the review pe- § 725.25(c). riod beginning on the date of the sub- (b)(1) If EPA receives an incomplete mission, the Director, or a designee, submission under this part, the Direc- may inform the submitter that the tor, or a designee, will notify the sub- running of the review period will remitter within 30 days of receipt that sume on the date EPA originally de- the submission is incomplete and that clared it incomplete. the review period will not begin until (3) If the Director, or a designee, EPA receives a complete submission. modifies the requirements for com- (2) If EPA obtains additional infor- pleting the submission or concurs with mation during the review period for EPA’s original determination, the re- any submission that indicates the view period will begin when EPA re- original submission was incomplete, ceives a complete submission.

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(f) If EPA discovers at any time that (2) The categories of use of the micro- a person submitted materially false or organism will be published as reported misleading statements in information in the submission unless this informa- submitted under this part, EPA may tion is claimed confidential. If con- find that the submission was incom- fidentiality is claimed, the generic in- plete from the date it was submitted, formation which is submitted under and take any other appropriate action. § 725.88 will be published. [62 FR 17932, April 11, 1997, as amended at 75 (3) A list of information submitted in FR 788, Jan. 6, 2010] accordance with § 725.160(a), 725.255, 725.260, 725.355, or 725.455, as appro- § 725.36 New information. priate, will be published. (a) During the review period, if a sub- (4) The submitter’s identity will be mitter possesses, controls, or knows of published, unless the submitter has new information that materially adds claimed it confidential. to, changes, or otherwise makes sig- (c) Publication of exemption decisions. nificantly more complete the informa- Following the expiration of the appro- tion included in the MCAN or exemp- priate review period for the exemption tion request, the submitter must send request, EPA will issue a notice in the that information within 10 days of re- FEDERAL REGISTER indicating whether ceiving the new information, but no the request has been approved or de- later than 5 days before the end of the nied and the reasons for the decision. review period. The new information must be sent in the same manner the § 725.50 EPA review. original notice or exemption was sent, (a) MCANs. The review period speci- as described in § 725.25(c)(1), (c)(2), and fied in section 5(a) of the Act for (c)(3). MCANs runs for 90 days from the date (b) The new submission must clearly the Document Control Officer receives identify the submitter, the MCAN or a complete submission, or the date exemption request to which the new in- EPA determines the submission is com- formation is related, and the number plete under § 725.33, unless the Agency assigned to that submission by EPA, if extends the review period under section known to the submitter. 5(c) of the Act and § 725.56. (c) If the new information becomes (b) Exemption requests. The review pe- available during the last 5 days of the riod starts on the date the Document review period, the submitter must im- Control Officer receives a complete ex- mediately inform the EPA contact for emption request, or the date EPA de- that submission by telephone of the termines the request is complete under new information. § 725.33, unless the Agency extends the [62 FR 17932, April 11, 1997, as amended at 75 review period under § 725.56. The review FR 789, Jan. 6, 2010] periods for exemption requests run as follows: § 725.40 Notice in the Federal Register. (1) TERAs. The review period for (a) Filing of FEDERAL REGISTER no- TERAs is 60 days. tice. After EPA receives a MCAN or an (2) TMEs. The review period for TMEs exemption request under this part, is 45 days. EPA will issue a notice in the FEDERAL (3) Tier II exemption requests. The re- REGISTER including the information view period for Tier II exemption re- specified in paragraph (b) of this sec- quests is 45 days. tion. (b) Contents of notice. (1) In the public § 725.54 Suspension of the review pe- interest, the specific microorganism riod. identity listed in the submission will (a) A submitter may voluntarily sus- be published in the FEDERAL REGISTER pend the running of the review period if unless the submitter has claimed the the Director, or a designee, agrees. If microorganism identity confidential. If the Director does not agree, the review the submitter claims confidentiality, a period will continue to run, and EPA generic name will be published in ac- will notify the submitter. A submitter cordance with § 725.85. may request a suspension at any time

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during the review period. The suspen- quest for suspension for submission to sion must be for a specified period of EPA. Paper requests for suspension time. must be submitted either via U.S. mail (b) A request for suspension may only to the Document Control Office (DCO) be submitted in a manner set forth in (7407M), Office of Pollution Prevention this paragraph. The request for suspen- and Toxics, Environmental Protection sion also may be made orally, includ- Agency, 1200 Pennsylvania Ave., NW., ing by telephone, to the submitter’s Washington, DC 20460–0001 or submitted EPA contact for that notice, subject to via courier to the Environmental Pro- paragraph (c) of this section. tection Agency, OPPT Document Con- (1) Older notices. Requests for suspen- trol Office (DCO), EPA East Bldg., 1201 sion for notices submitted before April Constitution Ave., NW., Rm. 6428, 6, 2010 must be submitted on paper ei- Washington, DC 20004. ther via U.S. mail to the Document (iii) Requests for suspension may be Control Office (DCO) (7407M), Office of submitted electronically to EPA via Pollution Prevention and Toxics, Envi- CDX. Such requests must be generated ronmental Protection Agency, 1200 and completed using e-PMN reporting Pennsylvania Ave., NW., Washington, software. See 40 CFR 720.40(a)(2)(iv) for DC 20460–0001 or submitted via courier information on how to obtain e-PMN to the Environmental Protection Agen- software. cy, OPPT Document Control Office (c) An oral request for suspension (DCO), EPA East Bldg., 1201 Constitu- may be granted by EPA for a maximum tion Ave., NW., Rm. 6428, Washington, of 15 days only. Requests for longer DC 20004. suspension must only be submitted in (2) Newer notices. For notices sub- the manner set forth in this paragraph. mitted on or after April 6, 2010, EPA (d) If the submitter has not made a will accept requests for suspension previous oral request, the running of only if submitted in accordance with the notice review period is suspended this paragraph: as of the date of receipt of the written (i) Requests for suspension may be paper request, electronic request on op- submitted on paper on or before April tical disc, or CDX submission by EPA. 6, 2011. All paper-based requests for sus- [62 FR 17932, April 11, 1997, as amended at 75 pension must be generated using e- FR 789, Jan. 6, 2010] PMN reporting software and be completed through the finalization step of § 725.56 Extension of the review pe- the software, and e-PMN software must riod. be used to print the request for suspen- (a) At any time during the review pe- sion for submission to EPA. Paper re- riod, EPA may unilaterally determine quests for suspension must be sub- that good cause exists to extend the remitted either via U.S. mail to the Doc- view period specified for MCANs, or the ument Control Office (DCO) (7407M), exemption requests. Office of Pollution Prevention and (b) If EPA makes such a determina- Toxics, Environmental Protection tion, EPA: Agency, 1200 Pennsylvania Ave., NW., (1) Will notify the submitter that Washington, DC 20460–0001 or submitted EPA is extending the review period for via courier to the Environmental Pro- a specified length of time and state the tection Agency, OPPT Document Con- reasons for the extension. trol Office (DCO), EPA East Bldg., 1201 (2) For MCANs, EPA may issue a no- Constitution Ave., NW., Rm. 6428, tice for publication in the FEDERAL Washington, DC 20004. REGISTER which states that EPA is ex- (ii) Requests for suspension may be tending the review period and gives the submitted as electronic files on optical reasons for the extension. disc on or before April 6, 2012. All re- (c) The total period of the extension quests for suspension submitted as may be for a period of up to the same electronic files on optical disc gen- length of time as specified for each erated using e-PMN reporting software type of submission in § 725.50. If the ini- and be completed through the finaliza- tial extension is for less than the total tion step of the software, and e-PMN time allowed, EPA may make addi- software must be used to print the re- tional extensions. However, the sum of

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the extensions may not exceed the drawal for submission to EPA. Paper total allowed. statements of withdrawal must be sub- (d) The following are examples of sit- mitted either via U.S. mail to the Doc- uations in which EPA may find that ument Control Office (DCO) (7407M), good cause exists for extending the re- Office of Pollution Prevention and view period: Toxics, Environmental Protection (1) EPA has reviewed the submission Agency, 1200 Pennsylvania Ave., NW., and is seeking additional information. Washington, DC 20460–0001 or submitted (2) EPA has received significant addi- via courier to the Environmental Pro- tional information during the review tection Agency, OPPT Document Con- period. trol Office (DCO), EPA East Bldg., 1201 (3) The submitter has failed to cor- Constitution Ave., NW., Rm. 6428, rect a submission after receiving EPA’s Washington, DC 20004. request under § 725.32. (ii) Statements of withdrawal be sub- (4) EPA has reviewed the submission mitted as electronic files on optical and determined that there is a signifi- disc on or before April 6, 2012. All state- cant possibility that the microorga- ments of withdrawal submitted as elec- nism will be regulated under section tronic files on optical disc must be gen- 5(e) or section 5(f) of the Act, but EPA erated using e-PMN reporting software is unable to initiate regulatory action and be completed through the finaliza- within the initial review period. tion step of the software. Optical discs containing electronic statements of § 725.60 Withdrawal of submission by withdrawal must be submitted by cou- the submitter. rier to the Environmental Protection (a) A submitter may withdraw a no- Agency, OPPT Document Control Of- tice during the notice review period by fice (DCO), EPA East Bldg., 1201 Con- submitting a statement of withdrawal stitution Ave., NW., Rm. 6428, Wash- in a manner set forth in this para- ington, DC 20004. graph. The withdrawal is effective upon (iii) Statements of withdrawal may receipt of the written paper request, be submitted electronically to EPA via electronic request on optical disc, or CDX. Prior to submission to EPA via CDX submission by EPA. CDX, such statements of withdrawal (1) Older notices. Statements of with- must be generated and completed using drawal for notices submitted before e-PMN reporting software. See 40 CFR April 6, 2010 must be submitted on 720.40(a)(2)(iv) for information on how paper either via U.S. mail to the Docu- to obtain e-PMN software. ment Control Office (DCO) (7407M), Of- (b) If a manufacturer, importer, or fice of Pollution Prevention and processor who withdrew a submission Toxics, Environmental Protection later resubmits a submission for the Agency, 1200 Pennsylvania Ave., NW., same microorganism, a new review pe- Washington, DC 20460–0001 or submitted riod begins. via courier to the Environmental Pro- [62 FR 17932, April 11, 1997, as amended at 75 tection Agency, OPPT Document Con- FR 789, Jan. 6, 2010] trol Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, § 725.65 Recordkeeping. Washington, DC 20004. (a) General provisions. (1) Any person (2) Newer notices. For notices sub- who submits a notice under this part mitted on or after April 6, 2010, EPA must retain documentation of informa- will accept statements of withdrawal tion in the submission, including: only if submitted in accordance with (i) Any data in the submitter’s pos- this paragraph: session or control; and (i) Statements of withdrawal may be (ii) Records of production volume for submitted on paper on or before April the first 3 years of manufacture, im- 6, 2011. All paper-based statements of port, or processing. withdrawal must be generated using e- (2) Any person who submits a notice PMN reporting software and be com- under this part must retain docu- pleted through the finalization step of mentation of the date of commence- the software, and e-PMN software must ment of testing, manufacture, import, be used to print the statement of with- or processing.

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(3) Any person who is exempt from (i) The effects of the new microorga- some or all of the reporting require- nism on health and the environment. ments of this part must retain docu- (ii) The magnitude of exposure of mentation that supports the exemp- human beings and the environment to tion. the new microorganism. (4) All information required by this (iii) The benefits of the new micro- section must be retained for 3 years organism for various uses and the from the date of commencement of availability of substitutes for such each activity for which records are re- uses. quired under this part. (iv) The reasonably ascertainable (b) Specific requirements. In addition economic consequences of granting or to the requirements of paragraph (a) of denying the exemption, including ef- this section, specific recordkeeping re- fects on the national economy, small quirements included in certain sub- business, and technological innovation. parts must also be followed. (3) Specific requirements. In addition (1) Additional recordkeeping require- to the requirements of paragraph (a)(2) ments for activities conducted inside a of this section, the specific information structure are set forth in § 725.235(h). requirements of the relevant subpart (2) Additional recordkeeping require- under which the exemption is sought ments for TERAs are set forth in should be met. § 725.250(f). (i) Exemption from MCAN reporting under subpart D. Information require- (3) Additional recordkeeping requirements are set forth in §§ 725.155 and ments for TMEs are set forth in 725.160. § 725.350(c). (ii) Exemption from TERA reporting (4) Additional recordkeeping require- under subpart E. Information requirements for Tier I exemptions under sub- ments are set forth in §§ 725.255 and part G of this part are set forth in 725.260. § 725.424(a)(5). (iii) Listing a recipient microorganism (5) Additional recordkeeping require- as eligible for exemption under subpart G. ments for Tier II exemptions under Information regarding the following subpart G of this part are set forth in criteria should be addressed in an ap- § 725.450(d). plication to list a recipient microorga- (6) Additional recordkeeping require- nism under § 725.420: ments for significant new uses of (A) Identification and classification microorganisms reported under subpart of the microorganism using available L of this part are set forth in § 725.850. genotypic and phenotypic information; Recordkeeping requirements may also (B) Information to evaluate the rela- be included when a microorganism and tionship of the microorganism to any significant new use are added to sub- other closely related microorganisms part M of this part. which have a potential for adverse effects on health or the environment; § 725.67 Applications to exempt new (C) A history of safe commercial use microorganisms from this part. for the microorganism; (a) Submission. (1) Any manufacturer (D) Commercial uses indicating that or importer of a new microorganism the microorganism products might be may request, under TSCA section subject to TSCA; 5(h)(4), an exemption, in whole or in (E) Studies which indicate the poten- part, from this part by sending a Let- tial for the microorganism to cause ad- ter of Application in the manner set verse effects to health or the environ- forth in § 725.25(c). ment; and (2) General provisions. The Letter of (F) Studies which indicate the sur- Application should provide information vival characteristics of the microorga- to show that any activities affected by nism in the environment. the requested exemption will not (b) Processing of the Letter of Applica- present an unreasonable risk of injury tion by EPA—(1) Grant of the Applica- to health or the environment. This in- tion. If, after consideration of the Let- formation should include data deter of Application and any other rel- scribed in the following paragraphs. evant information available to EPA,

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the Assistant Administrator for Pre- tion cannot be made. A final decision vention, Pesticides and Toxic Sub- terminating the rulemaking pro- stances makes a preliminary deter- ceeding will be published in the FED- mination that the new microorganism ERAL REGISTER. will not present an unreasonable risk [62 FR 17932, April 11, 1997, as amended at 75 of injury to health or the environment, FR 789, Jan. 6, 2010] the Assistant Administrator will propose a rule to grant the exemption § 725.70 Compliance. using the applicable procedures in part 750 of this chapter. (a) Failure to comply with any provi- (2) Denial of the application. If the As- sion of this part is a violation of sec- sistant Administrator decides that the tion 15 of the Act (15 U.S.C. 2614). preliminary determination described in (b) A person who manufactures or im- paragraph (b)(1) of this section cannot ports a microorganism before a MCAN be made, the application will be denied is submitted and the MCAN review pe- by sending the applicant a written riod expires is in violation of section 15 statement with the Assistant Adminis- of the Act even if that person was not trator’s reasons for denial. required to submit the MCAN under (c) Processing of the exemption—(1) Un- § 725.105. reasonable risk standard. Granting a sec- (c) Using a microorganism which a tion 5(h)(4) exemption requires a deter- person knew or had reason to know was mination that the activities will not manufactured, processed, or distrib- present an unreasonable risk of injury uted in commerce in violation of sec- to health or the environment. tion 5 of the Act or this part is a viola- (i) An unreasonable risk determination of section 15 of the Act (15 U.S.C. tion under the Act is an administrative 2614). judgment that requires balancing of (d) Failure or refusal to establish and the harm to health or the environment maintain records or to permit access to that a chemical substance may cause or copying of records, as required by and the magnitude and severity of that the Act, is a violation of section 15 of harm, against the social and economic the Act (15 U.S.C. 2614). effects on society of EPA action to re- (e) Failure or refusal to permit entry duce that harm. or inspection as required by section 11 (ii) A determination of unreasonable of the Act is a violation of section 15 of risk under section 5(h)(4) of the Act the Act (15 U.S.C. 2614). will examine the reasonably ascertain- (f) Violators may be subject to the able economic and social consequences civil and criminal penalties in section of granting or denying the exemption 16 of the Act (15 U.S.C. 2615) for each after consideration of the effect on the violation. Persons who submit materi- national economy, small business, ally misleading or false information in technological innovation, the environ- connection with the requirements of ment, and public health. any provision of this part may be sub- (2) Grant of the exemption. The exemp- ject to penalties calculated as if they tion will be granted if the Assistant never filed their submissions. Administrator determines, after con- (g) EPA may seek to enjoin the man- sideration of all relevant evidence pre- ufacture or processing of a microorga- sented in the rulemaking proceeding nism in violation of this part or act to described in paragraph (b)(1) of this seize any microorganism manufactured section, that the new microorganism or processed in violation of this part or will not present an unreasonable risk take other actions under the authority of injury to health or the environment. of section 7 of the Act (15 U.S.C. 2606) (3) Denial of the exemption. The ex- or section 17 of the Act (15 U.S.C. 2616). emption will be denied if the Assistant Administrator determines, after con- § 725.75 Inspections. sideration of all relevant evidence pre- EPA will conduct inspections under sented in the rulemaking proceeding section 11 of the Act to assure compli- described in paragraph (b)(1) of this ance with section 5 of the Act and this section, that the determination depart, to verify that information re- scribed in paragraph (c)(2) of this sec- quired by EPA under this part is true

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and correct, and to audit data sub- second copy, in accordance with mitted to EPA under this part. § 725.33. (iv) Any information contained with- Subpart C—Confidentiality and in the copy submitted under paragraph Public Access to Information (b)(2)(ii) of this section which has been in the public file for more than 30 days § 725.80 General provisions for con- will be presumed to be in the public do- fidentiality claims. main, notwithstanding any assertion of (a) A person may assert a claim of confidentiality made under this sec- confidentiality for any information tion. submitted to EPA under this part. (3) A person who submits information However, to EPA under this part must reassert a (1) Any person who asserts a claim of claim of confidentiality and substan- confidentiality for portions of the spe- tiate the claim each time the informa- cific microorganism identity must pro- tion is submitted to EPA. vide the information as described in (c) Any person asserting a claim of § 725.85. confidentiality under this part must (2) Any person who asserts a claim of substantiate each claim in accordance confidentiality for a use of a micro- with the requirements in § 725.94. organism must provide the information (d) EPA will disclose information as described in § 725.88. that is subject to a claim of confiden- (3) Any person who asserts a claim of tiality asserted under this section only confidentiality for information con- to the extent permitted by the Act, tained in a health and safety study of a this subpart, and part 2 of this title. microorganism must provide the infor- (e) If a submitter does not assert a mation described in § 725.92. claim of confidentiality for informa- (b) Any claim of confidentiality must tion at the time it is submitted to accompany the information when it is EPA, EPA may make the information submitted to EPA. public and place it in the public file (1) When a person submits any infor- without further notice to the sub- mation under this part, including any mitter. attachments, for which claims of confidentiality are made, the claim(s) § 725.85 Microorganism identity. must be asserted by circling the spe- (a) Claims applicable to the period prior cific information which is claimed and to commencement of manufacture or im- marking the page on which that infor- port for general commercial use—(1) When mation appears with an appropriate to make a claim. (i) A person who sub- designation such as ‘‘trade secret,’’ mits information to EPA under this ‘‘TSCA CBI,’’ or ‘‘confidential business part may assert a claim of confiden- information.’’ tiality for portions of the specific (2) If any information is claimed con- microorganism identity at the time of fidential, the person must submit two submission of the information. This copies of the document including the claim will apply only to the period claimed information. prior to the commencement of manu- (i) One copy of the document must be facture or import for general commer- complete. In that copy, the submitter cial use. must mark the information which is (ii) A person who submits informa- claimed as confidential in the manner tion to EPA under this part must re- prescribed in paragraph (b)(1) of this assert a claim of confidentiality and section. substantiate the claim each time the (ii) The second copy must be com- information is submitted to EPA. For plete except that all information example, if a person claims certain in- claimed as confidential in the first formation confidential in a TERA sub- copy must be deleted. EPA will place mission and wishes the same informa- the second copy in the public file. tion to remain confidential in a subse- (iii) If the submitter does not provide quent TERA or MCAN submission, the the second copy, the submission is in- person must reassert and resubstan- complete and the review period does tiate the claim in the subsequent sub- not begin to run until EPA receives the mission.

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(2) Assertion of claim. (i) A submitter the microorganism to the maximum may assert a claim of confidentiality extent possible. only if the submitter believes that pub- (ii) Within 30 days, EPA will inform lic disclosure prior to commencement the submitter either that one of the of manufacture or import for general proposed generic names is adequate or commercial use of the fact that anyone that none is adequate and further con- is initiating research and development sultation is necessary. activities pertaining to the specific (5) Use of generic name. If a submitter microorganism or intends to manufac- claims microorganism identity as con- ture or import the specific microorga- fidential under paragraph (a) of this nism for general commercial use would section, and if the submitter complies reveal confidential business informa- with paragraph (a)(2) of this section, tion. Claims must be substantiated in EPA will issue for publication in the accordance with the requirements of FEDERAL REGISTER notice described in § 725.94(a). § 725.40 the generic name proposed by (ii) If the submission includes a the submitter or one agreed upon by health and safety study concerning the EPA and the submitter. microorganism and if the claim for (b) Claims applicable to the period after confidentiality with respect to the spe- commencement of manufacture or import cific identity is denied in accordance for general commercial use—(1) Maintain- with § 725.92(c), EPA will deny a claim ing claim. Any claim of confidentiality asserted under paragraph (a) of this under paragraph (a) of this section is section. applicable only until the microorga- (3) Development of generic name. Any nism is manufactured or imported for person who asserts a claim of confiden- general commercial use and becomes tiality for portions of the specific eligible for inclusion on the Inventory. To maintain the confidential status of microorganism identity under this the microorganism identity when the paragraph must provide one of the fol- microorganism is added to the Inven- lowing items at the time the submis- tory, a submitter must reassert the sion is filed: confidentiality claim and substantiate (i) The generic name which was ac- the claim in the notice of commence- cepted by EPA in the prenotice con- ment of manufacture required under sultation conducted under paragraph § 725.190. (a)(4) of this section. (i) A submitter may not claim the (ii) One generic name that is only as microorganism identity confidential generic as necessary to protect the for the period after commencement of confidential identity of the particular manufacture or import for general microorganism. The name should re- commercial use unless the submitter veal the specific identity to the max- claimed the microorganism identity imum extent possible. The generic confidential under paragraph (a) of this name will be subject to EPA review section in the MCAN submitted for the and approval. microorganism. (4) Determination by EPA. (i) Any per- (ii) A submitter may claim the son who intends to assert a claim of microorganism identity confidential confidentiality for the specific identity for the period after commencement of of a new microorganism may seek a de- manufacture or import for general termination by EPA of an appropriate commercial use if the submitter did generic name for the microorganism not claim the microorganism identity before filing a submission. For this confidential under paragraph (a) of this purpose, the person should submit to section in any TERA submitted for the EPA: microorganism, but subsequently did (A) The specific identity of the claim microorganism identity con- microorganism. fidential in the MCAN submitted for (B) A proposed generic name(s) which the microorganism. is only as generic as necessary to pro- (2) Assertion of claim. (i) A person who tect the confidential identity of the believes that public disclosure of the new microorganism. The name(s) fact that anyone manufactures or im- should reveal the specific identity of ports the microorganism for general

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commercial use would reveal confiden- (iii) Upon receipt of a request de- tial business information may assert a scribed in § 725.15(b), EPA may require claim of confidentiality under para- the submitter who originally asserted graph (b) of this section. confidentiality for a microorganism to (ii) If the notice includes a health submit to EPA the information listed and safety study concerning the new in paragraph (b)(3)(iii) of this section. microorganism, and if the claim for (iv) Failure to submit any of the in- confidentiality with respect to the formation required under paragraph microorganism identity is denied in ac- (b)(3)(iii) of this section within 10 cal- cordance with § 725.92(c), EPA will deny endar days of receipt of a request by a claim asserted under paragraph (b) of EPA under paragraph (b) of this sec- this section. tion will constitute a waiver of the (3) Requirements for assertion. Any per- original submitter’s confidentiality son who asserts a confidentiality claim claim. In this event, EPA may place for microorganism identity must: the specific microorganism identity on (i) Comply with the requirements of the public Inventory without further paragraph (a)(3) of this section regard- notice to the original submitter. ing submission of a generic name. (6) Use of generic name on the public (ii) Agree that EPA may disclose to a Inventory. If a submitter asserts a person with a bona fide intent to manu- claim of confidentiality under para- facture or import the microorganism graph (b) of this section, EPA will ex- the fact that the particular microorga- amine the generic microorganism nism is included on the confidential In- name proposed by the submitter. ventory for purposes of notification (i) If EPA determines that the ge- under section 5(a)(1)(A) of the Act. neric name proposed by the submitter (iii) Have available and agree to fur- is only as generic as necessary to pro- nish to EPA upon request the taxo- tect the confidential identity of the nomic designations and supplemental particular microorganism, EPA will information required by § 725.12. place that generic name on the public (iv) Provide a detailed written sub- Inventory. stantiation of the claim, in accordance (ii) If EPA determines that the ge- with the requirements of § 725.94(b). neric name proposed by the submitter (4) Denial of claim. If the submitter is more generic than necessary to pro- does not meet the requirements of tect the confidential identity, EPA will paragraph (b) of this section, EPA will propose in writing, for review by the deny the claim of confidentiality. submitter, an alternative generic name (5) Acceptance of claim. (i) EPA will that will reveal the identity of the publish a generic name on the public microorganism to the maximum extent Inventory if: possible. (A) The submitter asserts a claim of (iii) If the generic name proposed by confidentiality in accordance with this EPA is acceptable to the submitter, paragraph. EPA will place that generic name on (B) No claim for confidentiality of the public Inventory. the microorganism identity as part of a (iv) If the generic name proposed by health and safety study has been de- EPA is not acceptable to the sub- nied in accordance with part 2 of this mitter, the submitter must explain in title or § 725.92. detail why disclosure of that generic (ii) Publication of a generic name on name would reveal confidential busi- the public Inventory does not create a ness information and propose another category for purposes of the Inventory. generic name which is only as generic Any person who has a bona fide intent as necessary to protect the confidential to manufacture or import a microorga- identity of the microorganism. If EPA nism which is described by a generic does not receive a response from the name on the public Inventory may sub- submitter within 30 days after the submit an inquiry to EPA under § 725.15(b) mitter receives the proposed name, to determine whether the particular EPA will place EPA’s chosen generic microorganism is included on the con- name on the public Inventory. If the fidential Inventory. submitter does provide the information

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requested, EPA will review the re- data, product development or mar- sponse. If the submitter’s proposed ge- keting plans, and advertising plans, for neric name is acceptable, EPA will which the person submits a claim of publish that generic name on the pub- confidentiality in accordance with lic Inventory. If the submitter’s pro- § 725.80. posed generic name is not acceptable, (b) Microorganism identity—(1) Claims EPA will notify the submitter of EPA’s applicable to the period prior to com- choice of a generic name. Thirty days mencement of manufacture or import for after this notification, EPA will place general commercial use. A claim of con- the chosen generic name on the public fidentiality for the period prior to com- Inventory. mencement of manufacture or import for general commercial use for the spe- § 725.88 Uses of a microorganism. cific identity of a microorganism for (a) Assertion of claim. A person who which a health and safety study was submits information to EPA under this submitted must be asserted in conjunc- part on the categories or proposed cat- tion with a claim asserted under egories of use of a microorganism may § 725.85(a). The submitter must substan- assert a claim of confidentiality for tiate each claim in accordance with this information. the requirements of § 725.94(a). (b) Requirements for claim. A sub- (2) Claims applicable to the period after mitter that asserts such a claim must: commencement of manufacture or import (1) Report the categories or proposed for general commercial use. To maintain categories of use of the microorganism. the confidential status of the specific (2) Provide, in nonconfidential form, identity of a microorganism for which a description of the uses that is only as a health and safety study was sub- generic as necessary to protect the mitted after commencement of manu- confidential business information. The facture or import for general commer- generic use description will be included cial use, the claim must be reasserted in the FEDERAL REGISTER notice de- and substantiated in conjunction with scribed in § 725.40. a claim under § 725.85(b). The submitter (c) Generic use description. The person must substantiate each claim in ac- must submit the information required cordance with the requirements of by paragraph (b) of this section by de- § 725.94(b). scribing the uses as precisely as pos- (c) Denial of confidentiality claim. EPA sible, without revealing the informa- will deny a claim of confidentiality for tion which is claimed confidential, to microorganism identity under para- disclose as much as possible how the graph (b) of this section, unless: use may result in human exposure to (1) The information would disclose the microorganism or its release to the processes used in the manufacture or environment. processing of a microorganism. (2) The microorganism identity is not § 725.92 Data from health and safety necessary to interpret a health and studies of microorganisms. safety study. (a) Information other than specific (d) Use of generic names. When EPA microorganism identity. Except as pro- discloses a health and safety study con- vided in paragraph (b) of this section, taining a microorganism identity, EPA will deny any claim of confiden- which the submitter has claimed con- tiality with respect to information in- fidential, and if the Agency has not de- cluded in a health and safety study of nied the claim under paragraph (c) of a microorganism, unless the informa- this section, EPA will identify the tion would disclose confidential busi- microorganism by the generic name se- ness information concerning: lected under § 725.85. (1) Processes used in the manufacture or processing of a microorganism. § 725.94 Substantiation requirements. (2) Information which is not in any (a) Claims applicable to the period prior way related to the effects of a micro- to commencement of manufacture or im- organism on health or the environ- port for general commercial use—(1) ment, such as, the name of the submit- MCAN, TME, Tier I certification, and ting company, cost or other financial Tier II exemption request requirements.

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Any person who submits a MCAN, nism otherwise would appear on the TME, Tier I certification, or Tier II ex- TSCA Inventory with no link between emption request should strictly limit the microorganism and the company or confidentiality claims to that informa- institution? How substantial would the tion which is confidential and propri- harmful effects of disclosure be? What etary to the business. is the causal relationship between the (i) If any information in the submis- disclosure and the harmful effects? sion is claimed as confidential business (ii) Has the identity of the micro- information, the submitter must sub- organism been kept confidential to the stantiate each claim by submitting extent that competitors do not know it written answers to the questions in is being manufactured or imported for paragraphs (c), (d), and (e) of this sec- general commercial use by anyone? tion at the time the person submits the (c) General questions. The following information. questions must be answered in detail (ii) If the submitter does not provide for each confidentiality claim: written substantiation as required in (1) For what period of time is a claim paragraph (a)(1)(i) of this section, the of confidentiality being asserted? If the submission will be considered incom- claim is to extend until a certain event plete and the review period will not or point in time, indicate that event or begin in accordance with § 725.33. time period. Explain why the informa- (2) TERA requirements. Any person tion should remain confidential until who submits a TERA, should strictly such point. limit confidentiality claims to that in- (2) Briefly describe any physical or formation which is confidential and procedural restrictions within the com- proprietary to the business. If any in- pany or institution relating to the use formation in such a submission is and storage of the information claimed claimed as confidential business infor- as confidential. What other steps, if mation, the submitter must have avail- any, apply to use or further disclosure able for each of those claims, and agree of the information? to furnish to EPA upon request, writ- (3) Has the information claimed as ten answers to the questions in para- confidential been disclosed to individ- graphs (d) and (e) of this section. uals outside of the company or institu- (b) Claims applicable to the period after tion? Will it be disclosed to such per- commencement of manufacture or import sons in the future? If so, what restric- for general commercial use. (1) If a sub- tions, if any, apply to use or further mitter claimed portions of the micro- disclosure of the information? organism identity confidential in the (4) Does the information claimed as MCAN and wants the identity to be confidential appear, or is it referred to, listed on the confidential Inventory, in any of the following questions? If the claim must be reasserted and sub- the answer is yes to any of these ques- stantiated at the time the Notice of tions, indicate where the information Commencement (NOC) is submitted appears and explain why it should under § 725.190. Otherwise, EPA will list nonetheless be treated as confidential. the specific microorganism identity on (i) Advertising or promotional mate- the public Inventory. rials for the microorganism or the re- (2) The submitter must substantiate sulting end product? the claim for confidentiality of the microorganism identity by answering (ii) Material safety data sheets or all of the questions in paragraphs (c), other similar materials for the micro- (d), and (e) in this section. In addition, organism or the resulting end product? the following questions must be an- (iii) Professional or trade publica- swered: tions? (i) What harmful effects to the com- (iv) Any other media available to the pany’s or institution’s competitive po- public or to competitors? sition, if any, would result if EPA pub- (v) Patents? lishes on the Inventory the identity of (vi) Local, State, or Federal agency the microorganism? How could a com- public files? petitor use such information given the (5) Has EPA, another Federal agency, fact that the identity of the microorga- a Federal court, or a State made any

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confidentiality determination regard- (2) Does the company or institution ing the information claimed as con- assert that disclosure of the microorga- fidential? If so, provide copies of such nism identity is not necessary to inter- determinations. pret any health and safety studies (6) For each type of information which have been submitted? If so, ex- claimed confidential, describe the plain how a less specific identity would harm to the company’s or institution’s be sufficient to interpret the studies. competitive position that would result if this information were disclosed. Why § 725.95 Public file. would this harm be substantial? How All information submitted, including could a competitor use such informa- any health and safety study of a micro- tion? What is the causal connection be- organism and other supporting docu- tween the disclosure and harm? mentation, will become part of the (7) If EPA disclosed to the public the public file for that submission, unless information claimed as confidential, such materials are claimed confiden- how difficult would it be for the com- tial. In addition, EPA may add mate- petitor to enter the market for the re- rials to the public file, unless such ma- sulting product? Consider such con- terials are claimed confidential. Any of straints as capital and marketing cost, the nonconfidential material described specialized technical expertise, or un- in this subpart will be available for usual processes. public inspection in the TSCA Public (d) Microorganism identity and produc- Docket Office, Rm. NE-B607, 401 M St., tion method. If confidentiality claims SW., Washington, DC, between the are asserted for the identity of the hours of noon to 4 p.m., Monday microorganism or information on how through Friday, excluding legal holi- the microorganism is produced, the fol- days. lowing questions must be answered: (1) Has the microorganism or method Subpart D—Microbial Commercial of production been patented in the U.S. Activities Notification Require- or elsewhere? If so, why is confiden- ments tiality necessary? (2) Does the microorganism leave the § 725.100 Scope and purpose. site of production or testing in a form (a) This subpart establishes proce- which is accessible to the public or to dures for submission of a notice to EPA competitors? What is the cost to a under section 5(a) of the Act for per- competitor, in time and money, to de- sons who manufacture, import, or proc- velop appropriate use conditions? What ess microorganisms for commercial factors facilitate or impede product purposes. This notice is called a Micro- analysis? bial Commercial Activity Notice (3) For each additional type of infor- (MCAN). It is expected that MCANs mation claimed as confidential, explain will in general only be submitted for what harm would result from disclo- microorganisms intended for general sure of each type of information if the commercial use. Persons who manufac- identity of the microorganism were to ture, import, or process a microorga- remain confidential. nism in small quantities solely for re- (e) Health and safety studies of micro- search and development as defined in organisms. If confidentiality claims are § 725.3 are not required to submit a no- asserted for information in a health or tice to EPA. Persons who manufacture, safety study of a microorganism, the import, or process a microorganism for following questions must be answered: research and development activities (1) Would the disclosure of the infor- that do not fit the definition of small mation claimed confidential reveal: quantities solely for research and de- confidential process information, or in- velopment may nonetheless qualify for formation unrelated to the effects of more limited reporting requirements in the microorganism on health and the Subpart E, including the TERA which environment. Describe the causal con- can be used for review of research and nection between the disclosure and development involving environmental harm. release.

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(b) Persons subject to MCAN submis- new microorganism which such person sion are described in § 725.105. intends to import for a commercial (c) Exclusions and exemptions spe- purpose. In addition, each importer cific to MCAN submissions are de- must comply with paragraph (b)(4) of scribed in § 725.110. this section. (d) Submission requirements applica- (4) EPA will hold the principal im- ble specifically to MCANs are described porter, or the importer that EPA deter- at § 725.150. mines must submit the MCAN when (e) Data requirements for MCANs are there is no principal importer under set forth in §§ 725.155 and 725.160. paragraph (b)(2) of this section, liable (f) EPA review procedures specific to for complying with this part, for com- MCANs are set forth in § 725.170. pleting the MCAN, and for the com- (g) Subparts A through C of this part pleteness and truthfulness of all infor- apply to any MCAN submitted under mation which it submits. this subpart. (c) Manufacturers, importers, or processors of microorganisms for a significant § 725.105 Persons who must report. new use. MCAN submission is required (a) Manufacturers of new microorga- for any person who intends to manufac- nisms. (1) MCAN submission is required ture, import, or process for commercial for any person who intends to manufac- purposes a microorganism identified as ture for commercial purposes in the having one or more significant new United States a new microorganism. uses in subpart M of this part, and who Exclusions are described in § 725.110. intends either to engage in a des- (2) If a person contracts with a manu- ignated significant new use of the facturer to produce or process a new microorganism or intends to distribute microorganism and the manufacturer it in commerce. Persons excluded from produces or processes the microorga- reporting on significant new uses of nism exclusively for that person, and microorganisms and additional proce- that person specifies the identity of the dures for reporting are described in microorganism, and controls the total subpart L of this part. amount produced and the basic technology for the plant process, then that § 725.110 Persons not subject to this person must submit the MCAN. If it is subpart. unclear who must report, EPA should Persons are not subject to the re- be contacted to determine who must quirements of this subpart for the fol- submit the MCAN. lowing activities: (3) Only manufacturers that are in- (a) Manufacturing, importing, or corporated, licensed, or doing business processing solely for research and de- in the United States may submit a velopment microorganisms that meet MCAN. the requirements for an exemption (b) Importers of new microorganisms. (1) under subpart E of this part. MCAN submission is required for a per- (b) Manufacturing, importing, or son who intends to import into the processing microorganisms for test United States for commercial purposes marketing activities which have been a new microorganism. Exclusions are granted an exemption under subpart F described in § 725.110. of this part. (2) When several persons are involved (c) Manufacturing or importing new in an import transaction, the MCAN microorganisms under the conditions must be submitted by the principal im- of a Tier I or Tier II exemption under porter. If no one person fits the prin- subpart G of this part. cipal importer definition in a particular transaction, the importer § 725.150 Procedural requirements for should contact EPA to determine who this subpart. must submit the MCAN for that trans- General requirements for all MCANs action. under this part are contained in sub- (3) Except as otherwise provided in parts A through C of this part. In addi- paragraph (b)(4) of this section, the tion, the following requirements apply provisions of this subpart D apply to to MCANs submitted under this sub- each person who submits a MCAN for a part:

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(a) When to submit a MCAN. A MCAN (d) Microorganism identity information. must be submitted at least 90 calendar Persons must submit sufficient infor- days prior to manufacturing or import- mation to allow the microorganism to ing a new microorganism and at least be accurately and unambiguously iden- 90 calendar days prior to manufac- tified for listing purposes as required turing, importing, or processing a by § 725.12. microorganism for a significant new (1) Description of the recipient micro- use. organism and the new microorganism. (i) (b) Section 5(b) of the Act. The sub- Data substantiating the taxonomy of mitter must comply with any applica- the recipient microorganism and the ble requirement of section 5(b) of the new microorganism to the level of Act for the submission of test data. strain, as appropriate. In lieu of data, (c) Contents of a MCAN. Each person EPA will accept a letter from a culture who submits a MCAN under this sub- collection substantiating taxonomy, part must provide the information and provided EPA, upon request to the sub- test data described in §§ 725.155 and mitter, may have access to the data 725.160. supporting the taxonomic designation. (d) Recordkeeping. Each person who (ii) Information on the morphological submits a MCAN under this subpart and physiological features of the new must comply with the recordkeeping microorganism. requirements of § 725.65. (iii) Other specific data by which the new microorganism may be uniquely § 725.155 Information to be included in identified for Inventory purposes. the MCAN. (2) Genetic construction of the new (a) Each person who is required by microorganism. (i) Data substantiating this part to submit a MCAN must in- the taxonomy of the donor organism(s). clude the information specified in para- In lieu of data, EPA will accept a letter graphs (c) through (h) of this section, from a culture collection substan- to the extent it is known to or reason- tiating taxonomy, provided EPA, upon ably ascertainable by that person. request to the submitter, may have ac- However, no person is required to in- cess to the data supporting the taxo- clude information which relates solely nomic designation. to exposure of humans or ecological (ii) Description of the traits for populations outside of the United which the new microorganism has been States. selected or developed and other traits (b) Each person should also submit, known to have been added or modified. in writing, all other information (iii) A detailed description of the ge- known to or reasonably ascertainable netic construction of the new micro- by that person that would permit EPA organism, including the technique used to make a reasoned evaluation of the to modify the microorganism (e.g., fu- health and environmental effects of the sion of cells, injection of DNA, microorganism, or any microbial mix- electroporation or chemical poration, ture or article, including information or methods used for induced mutation on its effects on humans, animals, and selection). The description should plants, and other microorganisms, and include, for example, a description of in the environment. The information the introduced genetic material, in- to be submitted under this subpart including any regulatory sequences and cludes the information listed in para- structural genes and the products of graphs (c) through (h) of this section those genes; how the introduced ge- relating to the manufacture, proc- netic material is expected to affect be- essing, distribution in commerce, use, havior of the recipient; expression, al- and disposal of the new microorganism. teration, and stability of the intro- (c) Submitter identification. (1) The duced genetic material; methods for name and headquarters address of the vector construction and introduction; submitter. and a description of the regulatory and (2) The name, address, and office tele- structural genes that are components phone number (including area code) of of the introduced genetic material, in- the principal technical contact rep- cluding genetic maps of the introduced resenting the submitter. sequences.

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(3) Phenotypic and ecological character- tured, processed, or used. For purposes istics. (i) Habitat, geographical dis- of this section, the site for a person tribution, and source of the recipient who imports a new microorganism is microorganism. the site of the operating unit within (ii) Survival and dissemination under the person’s organization which is di- relevant environmental conditions in- rectly responsible for importing the cluding a description of methods for new microorganism and which controls detecting the new or recipient micro- the import transaction. The import organism(s) in the environment and site may in some cases be the organiza- the sensitivity limit of detection for tion’s headquarters office in the United these techniques. States. (iii) A description of anticipated bio- (ii) A process description of each logical interactions with and effects on manufacture, processing, and use oper- target organisms and other organisms ation, which includes a diagram of the such as competitors, prey, hosts, major unit operations and conversions, symbionts, parasites, and pathogens; a the identity and entry point of all feed- description of host range; a description stocks, and the identity of any possible of pathogenicity, infectivity, toxicity, points of release of the new microorga- virulence, or action as a vector of nism from the process, including a de- pathogens; and capacity for genetic scription of all controls, including en- transfer under laboratory and relevant gineering controls, used to prevent environmental conditions. such releases. (iv) A description of anticipated in- (iii) Worker exposure information, volvement in biogeochemical or bio- including worker activities, physical logical cycling processes, involvement form of process streams which contain in rate limiting steps in mineral or nu- the new microorganism to which work- trient cycling, or involvement in inor- ers may be exposed, the number of ganic compounds cycling (such as pos- workers, and the duration of activities. sible sequestration or transformation (iv) Information on release of the new of heavy metals). microorganism to the environment, in- (e) Byproducts. A description of the byproducts resulting from the manu- cluding the quantity and media of re- facture, processing, use, and disposal of lease and type of control technology the new microorganism. used. (f) Total production volume. The esti- (v) A narrative description of the in- mated maximum amount of the new tended transport of the new microorga- microorganism intended to be manu- nism, including the means of transport, factured or imported during the first containment methods to be used during year of production and the estimated transport, and emergency containment maximum amount to be manufactured procedures to be followed in case of ac- or imported during any consecutive 12– cidental release. month period during the first 3 years of (vi) Procedures for disposal of any ar- production. This estimate may be by ticles, waste, clothing, or other equip- weight or volume and should include ment involved in the activity, includ- an estimation of viability (i.e., viable ing procedures for inactivation of the cells per unit volume or colony form- new microorganism, containment, dis- ing units per unit dry weight). infection, and disposal of contaminated (g) Use information. A description of items. intended categories of use by function (2) For sites not controlled by the and application, the estimated percent submitter, a description of each type of of production volume devoted to each processing and use operation involving category of use, and the percent of the the new microorganism, including new microorganism in the formulation identification of the estimated number for each commercial or consumer use. of processing or use sites, situations in (h) Worker exposure and environmental which worker exposure to and/or envi- release. (1) For sites controlled by the ronmental release of the new micro- submitter: organism will occur, the number of (i) The identity of sites where the workers exposed and the duration of new microorganism will be manufac- exposure; procedures for transport of

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the new microorganism and for dis- and address of the laboratory devel- posal, including procedures for inac- oping the data; progress to date; types tivation of the new microorganism; and of data collected, significant prelimi- control measures which limit worker nary results; and anticipated comple- exposure and environmental release. tion date. (ii) If a test or experiment is com- § 725.160 Submission of health and en- pleted before the MCAN review period vironmental effects data. ends, the person must submit the (a) Test data on the new microorganism study, report, or test, as specified in in the possession or control of the subparagraph (a)(3)(i) of this section, to mitter. (1) Except as provided in the address listed in § 725.25(c) within 10 § 725.25(h), and in addition to the infor- days of receiving it, but no later than mation required by § 725.155(d)(3), each 5 days before the end of the review pe- MCAN must contain all test data in riod. If the test or experiment is com- the submitter’s possession or control pleted during the last 5 days of the re- which are related to the effects on view period, the submitter must imme- health or the environment of any man- diately inform its EPA contact for that ufacture, processing, distribution in submission by telephone. commerce, use, or disposal of the new (5) For test data in the submitter’s microorganism or any microbial mix- possession or control which are not ture or article containing the new listed in paragraph (a)(2) of this sec- microorganism, or any combination of tion, a person is not required to submit such activities. This includes test data a complete report. The person must concerning the new microorganism in a submit a summary of the data. If EPA pure culture or formulated form as so requests, the person must submit a used or as intended to be used in one of full report within 10 days of the re- the activities listed above. quest, but no later than 5 days before (2) A full report or standard lit- the end of the review period. erature citation must be submitted for (6) All test data described under para- the following types of test data: graph (a) of this section are subject to (i) Health effects data. these requirements, regardless of their (ii) Ecological effects data. age, quality, or results. (iii) Physical and chemical properties (b) Other data concerning the health data. and environmental effects of the new (iv) Environmental fate characteris- microorganism that are known to or rea- tics. sonably ascertainable by the submitter. (1) (v) Monitoring data and other test Except as provided in § 725.25(h), and in data related to human exposure to or addition to the information required by environmental release of the new § 725.155(c)(3), any person who submits a microorganism. MCAN must describe the following (3)(i) If the data do not appear in the data, including any data from a health open scientific literature, the sub- and safety study of a microorganism, if mitter must provide a full report. A the data are related to effects on full report includes the experimental health or the environment of any man- methods and materials, results, discus- ufacture, processing, distribution in sion and data analysis, conclusions, commerce, use, or disposal of the references, and the name and address of microorganism, of any microbial mix- the laboratory that developed the data. ture or article containing the new (ii) If the data appear in the open sci- microorganism, or of any combination entific literature, the submitter need of such activities: only provide a standard literature cita- (i) Any data, other than test data, in tion. A standard literature citation in- the submitter’s possession or control. cludes author, title, periodical name, (ii) Any data, including test data, date of publication, volume, and page which are not in the submitter’s pos- numbers. session or control, but which are (4)(i) If a study, report, or test is in- known to or reasonably ascertainable complete when a person submits a by the submitter. For the purposes of MCAN, the submitter must identify the this section, data are known to or rea- nature and purpose of the study; name sonably ascertainable by the submitter

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if the data are known to any of its em- latory action against the microorga- ployees or other agents who are associ- nism in the future. ated with the research and develop- (2) After expiration of the MCAN re- ment, test marketing, or commercial view period, in the absence of regu- marketing of the microorganism. latory action by EPA under section (2) Data that must be described in- 5(e), 5(f), or 6(a) of the Act, the sub- clude data concerning the new micro- mitter may manufacture or import the organism in a pure culture or formu- microorganism even if the submitter lated form as used or as intended to be has not received notice of expiration. used in one of the activities listed in (3) Early notification that EPA has paragraph (b)(1) of this section. completed its review does not permit (3) The description of data reported commencement of manufacture or im- under paragraph (b) of this section port prior to the expiration of the 90– must include: day MCAN review period. (i) If the data appear in the open sci- (c) No person submitting a MCAN in entific literature, a standard literature response to the requirements of this citation, which includes the author, subpart may manufacture, import, or title, periodical name, date of publica- process a microorganism subject to tion, volume, and pages. this subpart until the review period, in- (ii) If the data are not available in cluding all extensions and suspensions, the open scientific literature, a de- has expired. scription of the type of data and summary of the results, if available, and § 725.190 Notice of commencement of the names and addresses of persons the manufacture or import. submitter believes may have possession (a) Applicability. Any person who or control of the data. commences the manufacture or import (4) All data described in paragraph (b) of a new microorganism for nonexempt, of this section are subject to these re- commercial purposes for which that quirements, regardless of their age, person previously submitted a section quality, or results; and regardless of 5(a) notice under this part must submit whether they are complete at the time a notice of commencement (NOC) of the MCAN is submitted. manufacture or import. (b) When to report. (1) If manufacture § 725.170 EPA review of the MCAN. or import for nonexempt, commercial General procedures for review of all purposes begins on or after May 27, submissions under this part are con- 1997, the submitter must submit the tained in §§ 725.28 through 725.60. In ad- NOC to EPA no later than 30 calendar dition, the following procedures apply days after the first day of such manu- to EPA review of MCANs submitted facture or import. under this subpart: (2) If manufacture or import for non- (a) Length of the review period. The exempt, commercial purposes began or MCAN review period specified in sec- will begin before May 27, 1997, the sub- tion 5(a) of the Act runs for 90 days mitter must submit the NOC by May from the date the Document Control 27, 1997. Officer for the Office of Pollution Pre- (3) Submission of an NOC prior to the vention and Toxics receives a complete commencement of manufacture or im- MCAN, or the date EPA determines the port is a violation of section 15 of the MCAN is complete under § 725.33, unless Act. the Agency extends the period under (c) Information to be reported. The section 5(c) of the Act and § 725.56. NOC must contain the following infor- (b) Notice of expiration of MCAN re- mation: Specific microorganism iden- view period. (1) EPA will notify the tity, MCAN number, and the date when submitter that the MCAN review pe- manufacture or import commences. If riod has expired or that EPA has com- the person claimed microorganism pleted its review of the MCAN. Expira- identity confidential in the MCAN, and tion of the review period does not con- wants the identity to be listed on the stitute EPA approval or certification confidential Inventory, the claim must of the new microorganism, and does be reasserted and resubstantiated in not mean that EPA may not take regu- accordance with § 725.85(b). Otherwise,

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EPA will list the specific microorga- stitution Ave., NW., Rm. 6428, Wash- nism identity on the public Inventory. ington, DC 20004. (d) Where to submit. All notices of (iii) Notices of commencement may commencement must be submitted to be submitted electronically to EPA via EPA in a manner set forth in this para- CDX on or after April 6, 2010. After graph. April 6, 2012 all notices of commence- (1) Older notices. Notices of comment must be submitted electronically mencement for a MCAN submitted be- to EPA via CDX. Prior to submission fore April 6, 2010 must be submitted on to EPA via CDX, such notices of com- paper either via U.S. mail to the Docu- mencement must be generated and ment Control Office (DCO) (7407M), Of- completed using e-PMN reporting soft- fice of Pollution Prevention and ware. See 40 CFR 720.40(a)(2)(iv) for in- Toxics, Environmental Protection formation on how to obtain e-PMN Agency, 1200 Pennsylvania Ave., NW., software. Washington, DC 20460–0001 or submitted [62 FR 17932, April 11, 1997, as amended at 75 via courier to the Environmental Pro- FR 789, Jan. 6, 2010] tection Agency, OPPT Document Con- trol Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Subpart E—Exemptions for Re- Washington, DC 20004. search and Development Ac- (2) Newer notices. For MCANs sub- tivities mitted on or after April 6, 2010, EPA will accept notices of commencement § 725.200 Scope and purpose. only if submitted in accordance with (a) This subpart describes exemptions this paragraph: from the reporting requirements under (i) Notices of commencement may be subpart D of this part for research and submitted on paper on or before April development activities involving 6, 2011. All paper-based notices of com- microorganisms. mencement must be generated using e- (b) In lieu of complying with subpart PMN reporting software and be com- D of this part, persons described in pleted through the finalization step of § 725.205 may submit a TSCA Experi- the software, and e-PMN software must mental Release Application (TERA) for be used to print the statement of with- research and development activities in- drawal for submission to EPA. Paper volving microorganisms or otherwise notices of commencement must be sub- comply with this subpart. mitted either via U.S. mail to the Doc- (c) Exemptions from part 725 are pro- ument Control Office (DCO) (7407M), vided at §§ 725.232, 725.234, and 725.238. Office of Pollution Prevention and (d) Submission requirements specific Toxics, Environmental Protection for TERAs are described at § 725.250. Agency, 1200 Pennsylvania Ave., NW., (e) Data requirements for TERAs are Washington, DC 20460–0001 or submitted set forth in §§ 725.255 and 725.260. via courier to the Environmental Pro- (f) EPA review procedures specific for tection Agency, OPPT Document Con- TERAs are set forth in §§ 725.270 and trol Office (DCO), EPA East Bldg., 1201 725.288. Constitution Ave., NW., Rm. 6428, (g) Subparts A through C of this part Washington, DC 20004. apply to any submission under this (ii) Notices of commencement may be subpart. submitted as electronic files on optical disc on or before April 6, 2012. All no- § 725.205 Persons who may report tices of commencement submitted as under this subpart. electronic files on optical disc must be (a) Commercial research and develop- generated using e-PMN reporting soft- ment activities involving new micro- ware and be completed through the fi- organisms or significant new uses of nalization step of the software. Optical microorganisms are subject to report- discs containing electronic notices of ing under this part unless they qualify commencement must be submitted by for an exemption under this part. courier to the Environmental Protec- (b) Commercial purposes for research tion Agency, OPPT Document Control and development means that the ac- Office (DCO), EPA East Bldg., 1201 Con- tivities are conducted with the purpose

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of obtaining an immediate or eventual scribed in §§ 725.232, 725.234, or 725.238 is commercial advantage for the re- exempt from TERA reporting under searcher and would include: this subpart. (1) All research and development ac- (d) A microorganism is not exempt tivities which are funded directly, in from reporting under subpart D of this whole or in part, by a commercial enti- part if any amount of the microorga- ty regardless of who is actually con- nism, including as part of a mixture, is ducting the research. Indications that processed, distributed in commerce, or the research and development activi- used, for any commercial purpose other ties are funded directly, in whole or in than research and development. part, may include, but are not limited (e) Quantities of the inactivated to: microorganism, or mixtures or articles (i) Situations in which a commercial containing the inactivated microorga- entity contracts directly with a univer- nism, remaining after completion of re- sity or researcher; or search and development activities may (ii) Situations in which a commercial be disposed of as a waste in accordance entity gives a conditional grant where with applicable Federal, State, and the commercial entity holds patent local regulations. rights, or establishes a joint venture (f) A person who manufactures, im- where the commercial entity holds pat- ports, or processes a microorganism ent or licensing rights; or solely for research and development is (iii) Any other situation in which the not required to comply with the re- commercial entity intends to obtain an quirements of this section if: immediate or eventual commercial ad- (1) The person is manufacturing a mi- vantage for the commercial entity and/ crobial pesticide identified in or the researcher. § 172.45(c), or (2) Research and development activi- (2) The person is manufacturing a mi- ties that are not funded directly by a crobial pesticide for which an Experi- commercial entity, if the researcher mental Use Permit is required, pursu- intends to obtain an immediate or ant to § 172.3; or eventual commercial advantage. Indi- cations that the researcher intends to (3) The person is manufacturing a mi- obtain an immediate or eventual com- crobial pesticide for which a notifica- mercial advantage may include, but tion or an Experimental Use Permit is are not limited to: not required to be submitted. (i) The research is directed toward § 725.232 Activities subject to the juris- developing a commercially viable im- diction of other Federal programs provement of a product already on the or agencies. market; or (ii) The researcher has sought or is This part does not apply to any re- seeking commercial funding for the search and development activity that purpose of developing a commercial ap- meets all of the following conditions. plication; or (a) The microorganism is manufac- (iii) The researcher or university has tured, imported, or processed solely for sought or is seeking a patent to protect research and development activities. a commercial application which the re- (b) There is no intentional testing of search is developing; or a microorganism outside of a struc- (iv) Other evidence that the re- ture, as structure is defined in § 725.3. searcher is aware of a commercial ap- (c)(1) The person receives research plication for the research and has di- funds from another Federal agency, rected the research toward developing and the funds are awarded on the con- that application. dition that the research will be con- (c) Certain research and development ducted in accordance with the relevant activities involving microorganisms portions of the NIH Guidelines, or subject to jurisdiction under the Act (2) A Federal agency or program oth- are exempt from reporting under this erwise imposes the legally binding re- part. A person conducting research and quirement that the research is to be development activities which meet the conducted in accordance with relevant conditions for the exemptions de- portions of the NIH Guidelines.

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§ 725.234 Activities conducted inside a containment/inactivation controls se- structure. lected under paragraph (d)(1) of this A person who manufactures, imports, section must be made upon EPA order. or processes a microorganism is not Failure to comply with EPA’s order subject to the reporting requirements shall result in automatic loss of eligi- under subpart D of this part if all of bility for an exemption under this sec- the following conditions are met: tion. (a) The microorganism is manufac- (e) The manufacturer, importer, or tured, imported, or processed solely for processor notifies all persons in its em- research and development activities. ploy or to whom it directly distributes (b) The microorganism is used by, or the microorganism, who are engaged in directly under the supervision of, a experimentation, research, or analysis technically qualified individual, as de- on the microorganism, including the fined in § 725.3. The technically quali- manufacture, processing, use, trans- fied individual must maintain docu- port, storage, and disposal of the mentation of the procedures selected to microorganism associated with re- comply with paragraph (d) of this sec- search and development activities, of tion and must ensure that the proce- any risk to health, identified under dures are used. § 725.235(a), which may be associated (c) There is no intentional testing of with the microorganism. The notifica- a microorganism outside of a struction must be made in accordance with ture, as structure is defined in § 725.3. § 725.235(b). (d) Containment and/or inactivation controls. (1) Selection and use of con- § 725.235 Conditions of exemption for tainment and/or inactivation controls activities conducted inside a structure. inside a structure for a particular microorganism shall take into account (a) Determination of risks. To deter- the following: mine whether notification under (i) Factors relevant to the organism’s § 725.234(e) is required, the manufac- ability to survive in the environment. turer, importer, or processor must do (ii) Potential routes of release in air, one of the following: solids and liquids; in or on waste mate- (1) For research conducted in accord- rials and equipment; in or on people, ance with the NIH Guidelines, the man- including maintenance and custodial ufacturer, importer, or processor must personnel; and in or on other orga- meet the conditions laid out at IV-B-4- nisms, such as insects and rodents. d of the NIH Guidelines; or (iii) Procedures for transfer of mate- (2) For all other research conducted rials between facilities. in accordance with § 725.234, the manu- (2) The technically qualified individ- facturer, importer, or processor must ual’s selection of containment and/or review and evaluate the following in- inactivation controls shall be approved formation to determine whether there and certified by an authorized official is reason to believe there is any risk to (other than the TQI) of the institution health which may be associated with that is conducting the test prior to the the microorganism: commencement of the test. (i) Information in its possession or (3) Records shall be developed and control concerning any significant ad- maintained describing the selection verse reaction of persons exposed to and use of containment and/or inac- the microorganism which may reason- tivation controls, as specified in ably be associated with such exposure. § 725.235(c). These records, which must (ii) Information provided to the man- be maintained at the location where ufacturer, importer, or processor by a the research and development activity supplier or any other person con- is being conducted, shall be submitted cerning a health risk believed to be as- to EPA upon written request and with- sociated with the microorganism. in the time frame specified in EPA’s (iii) Health and environmental ef- request. fects data in its possession or control (4) Subsequent to EPA review of concerning the microorganism. records in accordance with paragraph (iv) Information on health effects (d)(3) of this section, changes to the which accompanies any EPA rule or

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order issued under TSCA section 4, 5, mentation of the exemption, along or 6 of the Act that applies to the with standard laboratory records, shall microorganism and of which the manu- satisfy the recordkeeping requirement facturer, importer, or processor has specified in § 725.234(d)(3). knowledge. (ii) Documentation of how the fol- (b) Notification to employees and oth- lowing requirements are satisfied ers. (1) The manufacturer, importer, or under the NIH Guidelines: processor must notify the persons iden- (A) Copies or citations to informa- tified in § 725.234(e) by means of a con- tion reviewed and evaluated to deter- tainer labeling system, conspicuous mine the need to make any notifica- placement of notices in areas where ex- tion of risk. posure may occur, written notification (B) Documentation of the nature and to each person potentially exposed, or method of notification of risk, includ- any other method of notification which ing copies of any labels or written no- adequately informs persons of health tices used. risks which the manufacturer, im- (C) The names and addresses of any porter, or processor has reason to be- persons other than the manufacturer, lieve may be associated with the importer, or processor to whom the microorganism, as determined under substance is distributed, the identity of paragraph (a) of this section. the microorganism, the amount dis- (2) If the manufacturer, importer, or tributed, and copies of the notifica- processor distributes a microorganism tions required. manufactured, imported, or processed (2) For all other research conducted under this section to persons not in its in accordance with § 725.234, a person employ, the manufacturer, importer, or who manufacturers, imports, or proc- processor must in written form: esses a microorganism under this sec- (i) Notify those persons that the tion, must maintain the following microorganism is to be used only for records: research and development purposes and (i) Records describing selection and the requirements of § 725.234 are to be use of containment and/or inactivation met. controls required by § 725.234(d)(3) and (ii) Provide the notice of health risks certification by an authorized official specified in paragraph (b)(1) of this sec- required by § 725.234(d)(2) for each tion. microorganism. (3) The adequacy of any notification (ii) Copies or citations to informa- under this section is the responsibility tion reviewed and evaluated under of the manufacturer, importer, or proc- paragraph (a) of this section to deter- essor. mine the need to make any notifica- (c) Recordkeeping. (1) For research tion of risk. conducted in accordance with the NIH (iii) Documentation of the nature and Guidelines, a person who manufac- method of notification under paragraph tures, imports, or processes a micro- (b)(1) of this section, including copies organism under this section must re- of any labels or written notices used. tain the following records: (iv) The names and addresses of any (i) Documentation that the NIH persons other than the manufacturer, Guidelines have been adhered to. Such importer, or processor to whom the documentation shall include: substance is distributed, the identity of (A) For experiments subject to Insti- the microorganism, the amount dis- tutional Biosafety Committee review, tributed, and copies of the notifica- or notification simultaneous with initi- tions required under paragraph (b)(2) of ation of the experiment, the informa- this section. tion submitted for review or notification, along with standard laboratory § 725.238 Activities conducted outside records, shall satisfy the recordkeeping a structure. requirements specified in § 725.234(d)(3). (a) Exemption. (1) Research and devel- (B) For experiments exempt from In- opment activities involving intentional stitutional Biosafety Committee re- testing in the environment of certain view or notification simultaneous with microorganisms listed in § 725.239 may initiation of the experiment, docu- be conducted without prior review by

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EPA if all of the conditions of this sec- (1) For structural genes encoding tion and § 725.239 are met. marker sequences, the gene is limited (2) The research and development ac- to the aadH gene, which confers resist- tivity involving a microorganism listed ance to the antibiotics streptomycin in § 725.239 must be conducted by, or di- and spectinomycin. rectly under the supervision of, a tech- (2) For traits other than antibiotic nically qualified individual, as defined resistance, the structural gene must be in § 725.3. limited to the genera Bradyrhizobium (b) Certification. To be eligible for the and Rhizobium. exemption under this section, a manu- (B) The regulatory sequences permit- facturer or importer must submit to ting the expression of solely the gene(s) EPA prior to initiation of the activity of interest. a document signed by an authorized of- (C) Associated nucleotide sequences ficial containing the following infor- needed to move genetic material, in- mation: cluding linkers, homopolymers, adap- (1) Name, address, and telephone tors, transposons, insertion sequences, number of the manufacturer or im- and restriction enzyme sites. porter. (D) The vector nucleotide sequences (2) Location, estimated duration, and needed for vector transfer. planned start date of the test. (E) The vector nucleotide sequences (3) Certification of the following: needed for vector maintenance. (i) Compliance with the conditions of (3) Limitations on exposure. (i) The the exemption specified for the micro- test site area must be no more than 10 organism in § 725.239. terrestrial acres. (ii) If state and/or local authorities (ii) The technically qualified indi- have been notified of the activity, evi- vidual must select appropriate methods dence of notification. to limit the dissemination of modified (c) Recordkeeping. Persons who con- Bradyrhizobium japonicum. duct research and development activi- (b) Rhizobium meliloti. To qualify for ties under this section must comply an exemption under this section, all of with the recordkeeping requirements of the following conditions must be met § 725.65 and retain documentation that for a test involving Rhizobium meliloti: supports their compliance with the requirements of this section and the spe- (1) Characteristics of recipient micro- cific requirements for the microorga- organism. The recipient microorganism nism listed in § 725.239. is limited to strains of Rhizobium meliloti. § 725.239 Use of specific microorga- (2) Modification of traits. (i) The intro- nisms in activities conducted out- duced genetic material must meet the side a structure. criteria for poorly mobilizable listed in (a) Bradyrhizobium japonicum. To § 725.421(c) of this part. qualify for an exemption under this (ii) The introduced genetic material section, all of the following conditions must consist only of the following com- must be met for a test involving ponents: Bradyrhizobium japonicum: (A) The structural gene(s) of interest, (1) Characteristics of recipient micro- which have the following limitations: organism. The recipient microorganism (1) For structural genes encoding is limited to strains of Bradyrhizobium marker sequences, the gene is limited japonicum. to the aadH gene, which confers resist- (2) Modification of traits. (i) The intro- ance to the antibiotics streptomycin duced genetic material must meet the and spectinomycin. criteria for poorly mobilizable listed in (2) For traits other than antibiotic § 725.421(c). resistance, the structural gene must be (ii) The introduced genetic material limited to the genera Bradyrhizobium must consist only of the following com- and Rhizobium. ponents: (B) The regulatory sequences permit- (A) The structural gene(s) of interest, ting the expression of solely the gene(s) which have the following limitations: of interest.

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(C) Associated nucleotide sequences under the TERA must comply with all needed to move genetic material, in- terms of the TERA approval, as well as cluding linkers, homopolymers, adap- the conditions described in the TERA. tors, transposons, insertion sequences, (f) Recordkeeping. Persons submit- and restriction enzyme sites. ting a TERA must comply with the (D) The vector nucleotide sequences recordkeeping requirements of § 725.65. needed for vector transfer. In addition, the following requirements (E) The vector nucleotide sequences apply to TERAs: needed for vector maintenance. (1) Each person submitting a TERA (3) Limitations on exposure. (i) The under this part must retain docu- test site area must be no more than 10 mentation of information contained in terrestrial acres. (ii) The technically qualified indi- the TERA for a period of 3 years from vidual must select appropriate methods the date that the results of the study to limit the dissemination of modified are submitted to the Agency. Rhizobium meliloti. (2) Summaries of all data, conclusions, and reports resulting from the § 725.250 Procedural requirements for conduct of the research and develop- the TERA. ment activity under the TERA must be General requirements for all submis- submitted to the EPA address identi- sions under this part are contained in fied in § 725.25(c) within 1 year of the subparts A through C of this part. In termination of the activity. addition, the following requirements apply to TERAs submitted under this § 725.255 Information to be included in subpart: the TERA. (a) When to submit the TERA. Each (a) To review a TERA, EPA must person who is eligible to submit a have sufficient information to permit a TERA under this subpart must submit reasoned evaluation of the health and the TERA at least 60 calendar days be- environmental effects of the planned fore the person intends to initiate the test in the environment. The person proposed research and development ac- seeking EPA approval must submit all tivity. information known to or reasonably (b) Contents of the TERA. Each per- ascertainable by the submitter on the son who submits a TERA under this subpart must provide the information microorganism(s) and the research and and test data described in §§ 725.255 and development activity, including infor- 725.260. In addition, the submitter must mation not listed in paragraphs (c), (d), supply sufficient information to enable and (e) of this section that the person EPA to evaluate the effects of all ac- believes will be useful for EPA’s risk tivities for which approval is re- assessment. The TERA must be in quested. writing and must include at least the (c) A person may submit a TERA for information described in the following one or more microorganisms and one or paragraphs. more research and development activi- (b) When specific information is not ties, including a research program. submitted, an explanation of why such (d) EPA will either approve the information is not available or not ap- TERA, with or without conditions, or plicable must be included. disapprove it under procedures estab- (c) Persons applying for a TERA, lished in this subpart. must include the submitter identifica- (e) The manufacturer, importer, or tion and microorganism identity infor- processor who receives a TERA ap- mation required for MCANs in proval must comply with all terms of § 725.155(c), (d)(1), and (d)(2). the approval, as well as conditions de- (d) Persons applying for a TERA scribed in the TERA, and remains liable for compliance with all terms and must submit phenotypic and ecological conditions, regardless of who conducts characteristics information required in the research and development activity. § 725.155(d)(3) as it relates directly to Any person conducting the research the conditions of the proposed research and development activity approved and development activity.

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(e) Persons applying for a TERA § 725.260 Submission of health and en- must also submit the following infor- vironmental effects data. mation about the proposed research Each TERA must contain all avail- and development activity: able data concerning actual or poten- (1) A detailed description of the pro- tial effects on health or the environ- posed research and development activity. ment of the new microorganism that (i) The objectives and significance of are in the possession or control of the the activity and a rationale for testing submitter and a description of other the microorganisms in the environ- data known to or reasonably ascertain- ment. able by the submitter that will permit (ii) Number of microorganisms re- a reasoned evaluation of the planned leased (including viability per volume test in the environment. The data must if applicable) and the method(s) of ap- be reported in the manner described in plication or release. § 725.160(a)(3) and (b)(3). (iii) Characteristics of the test site(s), including location, geo- § 725.270 EPA review of the TERA. graphical, physical, chemical, and bio- General procedures for review of all logical features, proximity to human submissions under this part are con- habitation or activity, and description tained in §§ 725.28 through 725.60. In ad- of site characteristics that would influ- dition, the following procedures apply ence dispersal or confinement. to EPA review of applications sub- (iv) Target organisms (if the micro- mitted under this subpart: organism(s) to be tested has an in- (a) Length of the review period. (1) The tended target), including identification review period for the TERA will be 60 of each target organism and antici- days from the date the Document Con- pated mechanism and result of inter- trol Officer for the Office of Pollution action. Prevention and Toxics receives a com- (v) Planned start date and duration plete TERA, or the date EPA deter- of each activity. mines the TERA is complete under (vi) If State and/or local authorities § 725.33, unless EPA finds good cause for have been notified of the activity, evi- an extension under § 725.56. dence of notification. (2) A submitter shall not proceed (2) Information on monitoring, confine- with the research and development ac- ment, mitigation, and emergency termi- tivity described in the TERA unless nation procedures. (i) Confinement pro- and until EPA provides written ap- cedures for the activity, access and se- proval of the TERA. A submitter may receive early approval if a review is curity measures, and procedures for completed in less than 60 days. routine termination of the activity. (b) EPA decision regarding proposed (ii) Mitigation and emergency proce- TERA activity. (1) A decision con- dures. cerning a TERA under this subpart will (iii) Measures to detect and control be made by the Administrator, or a potential adverse effects. designee. (iv) Name of principal investigator (2) If EPA determines that the pro- and chief of site personnel responsible posed research and development activ- for emergency procedures. ity for the microorganism does not (v) Personal protective equipment, present an unreasonable risk of injury engineering controls, and procedures to to health or the environment, EPA will be followed to minimize dispersion of notify the submitter that the TERA is the microorganism(s) by people, ma- approved and that the submitter can chinery, or equipment. proceed with the proposed research and (vi) Procedures for disposal of any ar- development activity described in the ticles, waste, clothing, machinery, or TERA. other equipment involved in the exper- (3) EPA may include requirements imental release, including methods for and conditions in its approval of the inactivation of the microorganism(s), TERA that would be stated in the containment, disinfection, and disposal TERA approval under paragraph (c) of of contaminated items. this section.

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(4) If EPA concludes that it cannot which must be followed by the sub- determine that the proposed research mitter. and development activity described in (ii) If EPA determines that it can no the TERA will not present an unrea- longer conclude that the activity will sonable risk of injury to health or the not present an unreasonable risk of in- environment, EPA will deny the TERA jury to health or the environment, it and will provide reasons for the denial will notify the submitter in writing in writing. that EPA is revoking its approval and (c) TERA approval. (1) A TERA ap- state its reasons. In that event, the proval issued by EPA under this sec- submitter must terminate the research tion is legally binding on the TERA and development activity within 48 submitter. hours of receipt of the notice in accord- (2) When EPA approves a TERA, the ance with directions provided by EPA submitter must conduct the research in the notice. and development activity only as de- (b) Evidence of unreasonable risk. (1) If, scribed in the TERA and in accordance after approval of a TERA under this with any requirements and conditions subpart, EPA determines that the pro- prescribed by EPA in its approval of posed research and development activ- the TERA. ity will present an unreasonable risk of (3) Any person who fails to conduct injury to health or the environment, the research and development activity EPA will notify the submitter in writ- as described in the TERA and in ac- ing and state its reasons. cordance with any requirements and (2) In the notice, EPA may prescribe conditions prescribed by EPA in its ap- additional safeguards to address or re- proval of the TERA under this section, duce the risk, or may instruct the sub- shall be in violation of sections 5 and 15 mitter to suspend the research and de- of the Act and be subject to civil and velopment activities. criminal penalties under section 16 of (3) Within 48 hours, the submitter the Act. must implement the instructions contained in the notice. The submitter § 725.288 Revocation or modification may then submit additional informa- of TERA approval. tion or arguments concerning the mat- (a) Significant questions about risk. (1) ters raised by EPA and whether EPA If, after approval of a TERA under this should modify or revoke the approval subpart, EPA receives information of the TERA in accordance with para- which raises significant questions graph (a)(2) of this section. about EPA’s determination that the (4) EPA will consider the information activity does not present an unreason- and arguments in accordance with able risk of injury to health or the en- paragraph (a)(3) of this section. vironment, EPA will notify the sub- (5) Following consideration of the in- mitter in writing of those questions. formation and arguments under para- (2) The submitter may, within 10 graph (a)(3) of this section, if EPA noti- days of receipt of EPA’s notice, provide fies the submitter that the R&D activ- in writing additional information or ity must be suspended or terminted, arguments concerning the significance the submitter may resume the activity of the questions and whether EPA only upon written notice from EPA should modify or revoke the approval that EPA has approved resumption of of the TERA. the activity. In approving resumption (3) After considering any such infor- of an activity, EPA may prescribe addi- mation and arguments, EPA will de- tional conditions which must be fol- cide whether to change its determina- lowed by the submitter. tion regarding approval of the TERA. (c) Modifications. If, after approval of (i) If EPA determines that the activ- a TERA under this subpart, the sub- ity will not present an unreasonable mitter concludes that it is necessary to risk of injury to health or the environ- alter the conduct of the research and ment, it will notify the submitter in development activity in a manner writing. To make this finding, EPA which would result in the activity may prescribe additional conditions being different from that described in

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the TERA agreement and any condi- apply to applications submitted under tions EPA prescribed in its approval, this subpart: the submitter must inform the EPA (a) Prenotice consultation. EPA contact for the TERA and may not strongly suggests that for a TME, the modify the activity without the ap- applicant contact EPA for a prenotice proval of EPA. consultation regarding eligibility for a TME. Subpart F—Exemptions for Test (b) When to submit a TME application. Marketing Each person who is eligible to apply for a TME under this subpart must submit § 725.300 Scope and purpose. the application at least 45 calendar days before the person intends to com- (a) This subpart describes exemptions mence the test marketing activity. from the reporting requirements under (c) Recordkeeping. Each person who is subpart D of this part for test mar- granted a TME must comply with the keting activities involving microorga- recordkeeping requirements of § 725.65. nisms. In addition, any person who obtains a (b) In lieu of complying with subpart TME must retain documentation of D of this part, persons described in compliance with any restrictions im- § 725.305 may submit an application for posed by EPA when it grants the TME. a test marketing exemption (TME). This information must be retained for 3 (c) Submission requirements specific years from the final date of manufac- for TME applications are described at ture or import under the exemption. § 725.350. (d) Data requirements for TME appli- § 725.355 Information to be included in cations are set forth in § 725.355. the TME application. (e) EPA review procedures specific (a) To review a TME application, for TMEs are set forth in § 725.370. EPA must have sufficient information (f) Subparts A through C of this part to permit a reasoned evaluation of the apply to any submission under this health and environmental effects of the subpart. planned test marketing activity. The person seeking EPA approval must sub- § 725.305 Persons who may apply mit all information known to or rea- under this subpart. sonably ascertainable by the person on A person identified in this section the microorganism and the test mar- may apply for a test marketing exemp- keting activity, including information tion. EPA may grant the exemption if not listed in paragraphs (c), (d), and (e) the person demonstrates that the of this section that the person believes microorganism will not present an un- will demonstrate that the microorga- reasonable risk of injury to health or nism will not present an unreasonable the environment as a result of the test risk of injury to health or the environ- marketing. A person may apply under ment as a result of the test marketing. this subpart for the following test mar- The TME application must be in writ- keting activities: ing and must include at least the infor- (a) A person who intends to manufac- mation described in paragraphs (b), (c), ture or import for commercial purposes (d), and (e) of this section. a new microorganism. (b) When specific information is not (b) A person who intends to manufac- submitted, an explanation of why such ture, import, or process for commercial information is not available or not ap- purposes a microorganism identified in plicable must be included. subpart M of this part for a significant (c) Persons applying for a TME must new use. submit the submitter identification and microorganism identity informa- § 725.350 Procedural requirements for tion required for MCANs in § 725.155(c), this subpart. (d)(1), and (d)(2). General requirements for all submis- (d) Persons applying for a TME must sions under this part are contained in submit phenotypic and ecological char- subparts A through C of this part. In acteristics information required in addition, the following requirements § 725.155(d)(3) as it relates directly to

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the conditions of the proposed test porting of certain new microorganisms marketing activity. for commercial purposes. (e) Persons applying for a TME must (b) Recipient microorganisms eligible also submit the following information for the tiered exemption from review about the proposed test marketing ac- under this part are listed in § 725.420. tivity: (c) Criteria for the introduced ge- (1) Proposed test marketing activity. (i) netic material contained in the new The maximum quantity of the micro- microorganisms are described in organism which the applicant will § 725.421. manufacture or import for test mar- (d) Physical containment and control keting. (ii) The maximum number of persons technologies are described in § 725.422. who may be provided the microorga- (e) The conditions for the Tier I ex- nism during test marketing. emption are listed in § 725.424. (iii) The maximum number of persons (f) In lieu of complying with subpart who may be exposed to the microorga- D of this part, persons using recipient nism as a result of test marketing, in- microorganisms eligible for the tiered cluding information regarding duration exemption may submit a Tier II ex- and route of such exposures. emption request. The limited reporting (iv) A description of the test mar- requirements for the Tier II exemption, keting activity, including its duration including data requirements, are de- and how it can be distinguished from scribed in §§ 725.450 and 725.455. full-scale commercial production and (g) EPA review procedures for the research and development activities. Tier II exemption are set forth in (2) Health and environmental effects § 725.470. data. All existing data regarding health (h) Subparts A through C of this part and environmental effects of the apply to any submission under this microorganism must be reported in ac- subpart. cordance with § 725.160. § 725.420 Recipient microorganisms. § 725.370 EPA review of the TME application. The following recipient microorga- General procedures for review of all nisms are eligible for either exemption submissions under this part are con- under this subpart: tained in §§ 725.28 through 725.60. In ad- (a) Acetobacter aceti. dition, the following procedures apply (b) Aspergillus niger. to EPA review of TME applications (c) Aspergillus oryzae. submitted under this subpart: (d) Bacillus licheniformis. (a) No later than 45 days after EPA (e) Bacillus subtilis. receives a TME, the Agency will either (f) Clostridium acetobutylicum. approve or deny the application. (g) Escherichia coli K-12. (b) A submitter may only proceed (h) Penicillium roqueforti. with test marketing activities after re- (i) Saccharomyces cerevisiae. ceipt of EPA approval. (c) In approving a TME application, (j) Saccharomyces uvarum. EPA may impose any restrictions necessary to ensure that the microorga- § 725.421 Introduced genetic material. nism will not present an unreasonable For a new microorganism to qualify risk of injury to health and the envi- for either exemption under this sub- ronment as a result of test marketing. part, introduced genetic material must meet all of the criteria listed in this Subpart G—General Exemptions section. for New Microorganisms (a) Limited in size. The introduced genetic material must consist only of the § 725.400 Scope and purpose. following: (a) This subpart describes exemptions (1) The structural gene(s) of interest. from reporting under subpart D of this (2) The regulatory sequences permit- part, and from review under this part ting the expression of solely the gene(s) altogether, for manufacturing and im- of interest.

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(3) Associated nucleotide sequences rectly toxic to target cells, yet still ad- needed to move genetic material, in- versely affects humans. An example of cluding linkers, homopolymers, adap- a sequence which indirectly contrib- tors, transposons, insertion sequences, utes to toxic effects is the sequence and restriction enzyme sites. which encodes the portion of the botu- (4) The nucleotide sequences needed linum toxin, listed in paragraph (d)(3) for vector transfer. of this section, capable of blocking the (5) The nucleotide sequences needed release of acetylcholine from for vector maintenance. gangliosides. Botulinum toxin affects (b) Well-characterized. For introduced neuromuscular junctions by its block- genetic material, well-characterized age of acetylcholine release, leading to means that the following have been de- irreversible relaxation of muscles and termined: respiratory arrest. (1) The function of all of the products (B) It binds a toxin or toxin precursor expressed from the structural gene(s). to target human cells. (2) The function of sequences that (C) It facilitates intracellular trans- participate in the regulation of expres- port of a toxin in target human cells. sion of the structural gene(s). (ii) While these toxins are listed (3) The presence or absence of associ- (with synonyms in parentheses) in ated nucleotide sequences and their as- paragraphs (d)(2) through (d)(7) of this sociated functions, where associated section according to the source orga- nucleotide sequences are those se- nism, it is use of the nucleotide sequences needed to move genetic mate- quences that encode the toxins that is rial including linkers, homopolymers, being restricted and not the use of the adaptors, transposons, insertion se- source organisms. The source orga- quences, and restriction enzyme sites. nisms are listed to provide specificity (c) Poorly mobilizable. The ability of in identification of sequences whose the introduced genetic material to be use is restricted. Although similar or transferred and mobilized is inac- identical sequences may be isolated tivated, with a resulting frequency of from organisms other than those listed transfer of less than 10¥8 transfer below in paragraphs (d)(2) through events per recipient. (d)(7) of this section, these comparable (d) Free of certain sequences. (1) The toxin sequences, regardless of the orga- introduced genetic material must not nism from which they are derived, contain a functional portion of any of must not be included in the introduced the toxin-encoding sequences described genetic material. in this paragraph (d). (2) Sequences for protein synthesis in- (i) For the purposes of this section, a hibitor. functional portion of a toxin-encoding Sequence Source Toxin Name sequence means any sequence which codes for a polypeptide that has one of Corynebacterium diphtheriae Diphtheria toxin & C. ulcerans the following effects: Pseudomonas aeruginosa Exotoxin A (A) It directly or indirectly contrib- Shigella dysenteriae Shigella toxin (Shiga toxin, utes to toxic effects in humans. Di- Shigella dysenteriae type I toxin, Vero cell toxin) rectly contributes to toxic effects in Abrus precatorius, seeds Abrin humans means those sequences encod- Ricinus communis, seeds Ricin ing polypeptides that have direct tox- (3) Sequences for neurotoxins. icity to target cells. An example of a sequence which directly contributes to Sequence Source Toxin Name toxic effects in humans is one which Clostridium botulinum Neurotoxins A, B, C1, D, E, encodes the portion of diphtheria F, G (Botulinum toxins, toxin, listed in paragraph (d)(2) of this botulinal toxins) section, capable of interacting with Clostridium tetani Tetanus toxin (tetanospasmin) elongation factor 2, leading to inhibi- Proteus mirabilis Neurotoxin tion of protein synthesis in target res- Staphylococcus aureus Alpha toxin (alpha lysin) piratory, heart, kidney, and nerve tis- Yersinia pestis Murine toxin sues. Indirectly contributes to toxic ef- Snake toxins Bungarus caeruleus Caeruleotoxin fects in humans means a sequence Bungarus multicinctus Beta-bungarotoxin whose encoded polypeptide is not di- (phospholipase)

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Sequence Source Toxin Name (7) Sequences that are general cytotoxins. Crotalus spp. Crotoxin (phospholipase) Dendroaspis viridis Neurotoxin Sequence Source Toxin Name Naja naja varieties Neurotoxin Notechia scutatus Notexin (phospholipase) Adenia digitata Modeccin Oxyuranus scutellatus Taipoxin Aeromonas hydrophila Aerolysin (beta-lysin, Invertebrate toxins cytotoxic lysin) Chironex fleckeri Neurotoxin Clostridium difficile Cytotoxin (toxin B) Androctnus australis Neurotoxin Centruroides sculpturatus Neurotoxin Clostridium perfringens Beta-toxin; Epsilon-toxin; Kappa-toxin (4) Sequences for oxygen labile Escherichia coli & other Cytotoxin (Shiga-like toxin, cytolysins. Enterobacteriaceae spp. Vero cell toxin) Pseudomonas aeruginosa Proteases Sequence Source Toxin Name Staphylococcus aureus Gamma lysin (Gamma toxin); Enterotoxins (SEA, SEB, Bacillus alve Alveolysin SEC, SED SEE); Bacillus cereus Cereolysin Pyrogenic exotoxins A B; Bacillus laterosporus Laterosporolysin Toxic shock syndrome tox- Bacillus thuringiensis Thuringiolysin ins (TSST-1) Clostridium bifermentans Lysin Staphylococcus aureus & Leucocidin (leukocidin, Clostridium botulinum Lysin Pseudomonas aeruginosa cytotoxin) Clostridium caproicum Lysin Streptococcus pyogenes Streptolysin S (SLS); Clostridium chauvoei Delta-toxin Erythrogenic toxins (scarlet Clostridium histolyticum Epsilon-toxin fever toxins, pyrogenic Clostridium novyi Gamma-toxin exotoxins) Clostridium oedematiens Delta-toxin Clostridium perfringens Theta-toxin (Perfringolysin) Yersinia enterocolitica Heat-stable enterotoxins (ST) Clostridium septicum Delta-toxin Clostridium sordellii Lysin § 725.422 Physical containment and Clostridium tetani Tetanolysin control technologies. Listeria monocytogenes Listeriolysin (A B) Streptococcus pneumoniae Pneumolysin The manufacturer must meet all of Streptococcus pyogene Streptolysin O (SLO) the following criteria for physical con- (5) Sequences for toxins affecting mem- tainment and control technologies for brane function. any facility in which the new microorganism will be used for a Tier I ex- Sequence Source Toxin Name emption; these criteria also serve as Bacillus anthracis Edema factor (Factors I II); guidance for a Tier II exemption. Lethal factor (Factors II III) (a) Use a structure that is designed Bacillus cereus Enterotoxin (diarrheagenic and operated to contain the new micro- toxin, mouse lethal factor) Bordetella pertussis Adenylate cyclase (Heat-la- organism. bile factor); Pertussigen (b) Control access to the structure. (pertussis toxin, islet acti- (c) Provide written, published, and vating factor, histamine sensitizing factor, implemented procedures for the safety lymphocytosis promoting of personnel and control of hygiene. factor) (d) Use inactivation procedures dem- Clostridium botulinum C2 toxin Clostridium difficile Enterotoxin (toxin A) onstrated and documented to be effec- Clostridium perfringens Beta-toxin; Delta-toxin tive against the new microorganism Escherichia coli & other Heat-labile enterotoxins (LT); contained in liquid and solid wastes Enterobacteriaceae spp. Heat-stable enterotoxins (STa, ST1 subtypes ST1a prior to disposal of the wastes. The in- ST1b; also STb, STII) activation procedures must reduce via- Legionella pneumophila Cytolysin ble microbial populations by at least 6 Vibrio cholerae & Vibrio Cholera toxin (choleragen) logs in liquid and solid wastes. mimicus (e) Use features known to be effective (6) Sequences that affect membrane in minimizing viable microbial popu- integrity. lations in aerosols and exhaust gases Sequence Source Toxin Name released from the structure, and document use of such features. Clostridium bifermentans & Lecithinase (f) Use systems for controlling dis- other Clostridium spp Clostridium perfringens Alpha-toxin (phospholipase semination of the new microorganism C, lecithinase); Enterotoxin through other routes, and document Corynebacterium pyogenes & Cytolysin (phospholipase C), use of such features. other Corynebacterium spp. Ovis toxin (sphingomyelinase D) (g) Have in place emergency clean-up Staphylococcus aureus Beta-lysin (beta toxin) procedures.

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§ 725.424 Requirements for the Tier I (i) Compliance with the introduced exemption. genetic material criteria described in (a) Conditions of exemption. The manu- § 725.421. facture or import of a new microorga- (ii) Compliance with the containment nism for commercial purposes is not requirements described in § 725.422, in- subject to review under this part if all cluding the provision in paragraph of the following conditions are met for (a)(3) of this section. all activities involving the new micro- (5) The site of waste disposal and the organism: type of permits for disposal, the permit (1) The recipient microorganism is numbers and the institutions issuing listed in and meets any requirements the permits. specified in § 725.420. (6) The certification statement re- (2) The introduced genetic material quired in § 725.25(b). Certification of meets the criteria under § 725.421. submission of test data is not required (3) The physical containment and for the Tier I exemption. control technologies of any facility in which the microorganism will be man- § 725.426 Applicability of the Tier I ex- ufactured, processed, or used meet the emption. criteria under § 725.422. The Tier I exemption under § 725.424 (4) The manufacturer or importer applies only to a manufacturer or im- submits a certification described in porter of a new microorganism that paragraph (b) of this section to EPA at certifies that the microorganism will least 10 days before commencing initial be used in all cases in compliance with manufacture or import of a new micro- §§ 725.420, 725.421, and 725.422. organism derived from a recipient microorganism listed in § 725.420. § 725.428 Requirements for the Tier II (5) The manufacturer or importer exemption. complies with the recordkeeping re- The manufacturer or importer of a quirements of § 725.65 and maintains new microorganism for commercial records for the initial and subsequent purposes may submit to EPA a Tier II uses of the new microorganism that exemption request in lieu of a MCAN verify compliance with the following: under subpart D of this part if all of (i) The certifications made in para- the following conditions are met: graph (b) of this section. (a) The recipient microorganism is (ii) All the eligibility criteria for the listed in and meets any requirements Tier I exemption including the criteria specified in § 725.420. for the recipient microorganism, the introduced genetic material, the phys- (b) The introduced genetic material ical containment and control tech- meets the criteria under § 725.421. nologies. (c) Adequate physical containment (b) Certification. To be eligible for the and control technologies are used. The Tier I exemption under this subpart, criteria listed under § 725.422 for phys- the manufacturer or importer must ical containment and control tech- submit to EPA a document signed by a nologies of facilities should be used as responsible company official con- guidance to satisfy the Tier II exemp- taining the information listed in this tion request data requirements listed paragraph. at § 725.455(d). EPA will review proposed (1) Name and address of manufac- process and containment procedures as turer or importer. part of the submission for a Tier II ex- (2) Date when manufacture or import emption under this section. is expected to begin. (3) The identification (genus, species) § 725.450 Procedural requirements for of the recipient microorganism listed the Tier II exemption. in § 725.420 which is being used to create General requirements for all submis- the new microorganism which will be sions under this part are contained in used under the conditions of the Tier I § 725.25. In addition, the following re- exemption. quirements apply to requests sub- (4) Certification of the following: mitted under this subpart:

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(a) Prenotice consultation. EPA substantiated by a letter from a cul- strongly suggests that for a Tier II ex- ture collection or a brief summary of emption, the submitter contact the the results of tests conducted for taxo- Agency for a prenotice consultation re- nomic identification. garding eligibility for the exemption. (2) Type of genetic modification and (b) When to submit the Tier II exemp- the function of the introduced genetic tion request. Each person who is eligible material. to submit a Tier II exemption request (3) Site of insertion. under this subpart must submit the re- (4) Certification of compliance with quest at least 45 calendar days before the introduced genetic material cri- the person intends to commence manu- teria described in § 725.421. facture or import. (c) Production volume. Production vol- (c) Contents of the Tier II exemption re- ume, including total liters per year, quest. Each person who submits a re- and the maximum cell concentration quest under this subpart must provide the information described in §§ 725.428 achieved during the production proc- and 725.455, as well as information ess. known to or reasonably ascertainable (d) Process and containment informa- by the person that would permit EPA tion. (1) A description of the process in- to determine that use of the micro- cluding the following: organism, under the conditions speci- (i) Identity and location of the manu- fied in the request, will not present an facturing site(s). unreasonable risk of injury to health (ii) Process flow diagram illustrating or the environment. the production process, including (d) Recordkeeping. Each person who downstream separations, and indi- submits a request under this subpart cating the containment envelope must comply with the recordkeeping around the appropriate equipment. requirements of § 725.65. In addition, (iii) Identities and quantities of feed- the submitter should maintain records stocks. which contain information that (iv) Sources and quantities of poten- verifies compliance with the following: tial releases to both the workplace and (1) The certifications made in the re- environment, and a description of engi- quest. neering controls, inactivation proce- (2) All the eligibility criteria for the dures, and other measures which will Tier II exemption request including the reduce worker exposure and environ- criteria for the recipient microorga- mental releases. nism, the introduced genetic material, (v) A description of procedures which the physical containment and control will be undertaken to prevent fugitive technologies. emissions, i.e. leak detection and re- § 725.455 Information to be included in pair program. the Tier II exemption request. (vi) A description of procedures/safe- The submitter must indicate clearly guards to prevent and mitigate acci- that the submission is a Tier II exemp- dental releases to the workplace and tion request for a microorganism in- the environment. stead of the MCAN under subpart D of (2) Certification of those elements of this part and must submit the fol- the containment criteria described in lowing information: § 725.422 with which the manufacturer (a) Submitter identification. (1) The is in compliance, including stating by name and headquarters address of the number the elements with which the submitter. manufacturer is in full compliance. (2) The name, address, and office tele- (e) The site of waste disposal and the phone number (including area code) of type of permits for disposal, the permit the principal technical contact rep- numbers and the institutions issuing resenting the submitter. the permits. (b) Microorganism identity information. (f) The certification statement re- (1) Identification (genus, species, and quired in § 725.25(b). Certification of strain) of the recipient microorganism. submission of test data is not required Genus, species designation should be for the Tier II exemption.

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§ 725.470 EPA review of the Tier II ex- Agency will either approve or deny the emption request. request. General procedures for review of all (2) In approving a request, EPA may submissions under this part are con- impose any restrictions necessary to tained in §§ 725.28 through 725.60. In ad- ensure that the microorganism will not dition, the following procedures apply present an unreasonable risk of injury to EPA review of Tier II exemption re- to health and the environment as a requests submitted under this subpart: sult of general commercial use. (a) Length of the review period. The re- (f) EPA may seek to enjoin the man- view period for the request will be 45 ufacture or import of a microorganism days from the date the Document Con- in violation of this subpart, or act to trol Officer for the Office of Pollution seize any microorganism manufactured Prevention and Toxics receives a com- or imported in violation of this section plete request, or the date EPA deter- or take other actions under the author- mines the request is complete under ity of sections 7 or 17 of the Act. § 725.33, unless the Agency extends the (g) A manufacturer or importer may review period for good cause under only proceed after receipt of EPA ap- § 725.56. proval. (b) Criteria for review. EPA will review the request to determine that the new Subparts H–K [Reserved] microorganism complies with § 725.428 and that its manufacture, processing, Subpart L—Additional Procedures use, and disposal as described in the request will not present an unreasonable for Reporting on Significant risk of injury to health or the environ- New Uses of Microorganisms ment. § 725.900 Scope and purpose. (c) EPA decision regarding the Tier II exemption request. A decision con- (a) This subpart describes additional cerning a request under this subpart provisions governing submission of will be made by the Administrator, or MCANs for microorganisms subject to a designee. significant new use rules identified in (d) Determination that the microorga- subpart M of this part. nism is ineligible for a Tier II review. (1) (b) Manufacturers, importers, and EPA may determine that the manufac- processors described in § 725.105(c) must turer or importer is not eligible for submit a MCAN under subpart D of this Tier II review, because the microorga- part for significant new uses of micro- nism does not meet the criteria under organisms described in subpart M of § 725.428 or the Administrator, or a des- this part, unless they are excluded ignee, decides that there is insufficient under §§ 725.910 or 725.912. information to determine that the con- (c) Section 725.920 discusses exports ditions of manufacture, processing, and imports. use, or disposal of the microorganism (d) Additional recordkeeping require- as described in the request will not ments specific to significant new uses present an unreasonable risk to health of microorganisms are described in or the environment. § 725.950. (2) If the Agency makes this deter- (e) Section 725.975 describes how EPA mination, the Administrator, or a des- will approve alternative means of com- ignee will notify the manufacturer or plying with significant new use re- importer by telephone, followed by a quirements designated in subpart M of letter, that the request has been de- this part. nied. The letter will explain reasons for (f) Expedited procedures for promul- the denial. gating significant new use require- (3) If the request is denied, the manu- ments under subpart M of this part for facturer or importer may submit the microorganisms subject to section 5(e) information necessary to constitute a orders are discussed in §§ 725.980 and MCAN under subpart D of this part. 725.984. (e) Approval or denial of the Tier II ex- (g) This subpart L contains provi- emption request. (1) No later than 45 sions governing submission and review days after EPA receives a request, the of notices for the microorganisms and

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significant new uses identified in sub- organism identified in the specific sec- part M of this part. The provisions of tion in subpart M of this part that a re- this subpart L apply to the microorga- cipient intends to engage in a des- nisms and significant new uses identi- ignated significant new use of that fied in subpart M of this part, except to microorganism without submitting a the extent that they are specifically MCAN under this part. modified or supplanted by specific re- (c) A person who processes a micro- quirements in subpart M of this part. organism identified in a specific sec- In the event of a conflict between the tion in subpart M of this part for a sig- provisions of this subpart L and the nificant new use of that microorganism provisions of subpart M of this part, is not required to submit a MCAN if the provisions of subpart M of this part that person can document each of the shall govern. following: (h) The provisions of subparts A (1) That the person does not know the through F of this part also apply to specific microorganism identity of the subparts L and M of this part. For pur- microorganism being processed, and poses of subparts L and M of this part, (2) That the person is processing the wherever the words ‘‘microorganism’’ microorganism without knowledge or ‘‘new microorganism’’ appear in sub- that the microorganism is identified in parts A through F of this part, it shall subpart M of this part. mean the microorganism subject to (d)(1) If at any time after com- subparts L and M of this part. In the mencing distribution in commerce of a event of a conflict between the provi- microorganism identified in a specific sions of subparts A through F and the section in subpart M of this part, a per- provisions of subparts L and M of this son who manufactures, imports, or part, the provisions of subparts L and processes a microorganism described in M of this part shall govern. subpart M of this part and distributes it in commerce has knowledge that a § 725.910 Persons excluded from re- recipient of the microorganism is en- porting significant new uses. gaging in a significant new use of that (a) A person who intends to manufac- microorganism designated in that sec- ture, import, or process a microorga- tion without submitting a MCAN under nism identified in subpart M of this this part, the person is required to part and who intends to distribute it in cease supplying the microorganism to commerce is not required to submit a that recipient and to submit a MCAN MCAN under subpart D of this part, if for that microorganism and significant that person can document one or more new use, unless the person is able to of the following as to each recipient of document each of the following: the microorganism from that person: (i) That the person has notified the (1) That the person has notified the recipient and EPA enforcement au- recipient, in writing, of the specific thorities (at the address in paragraph section in subpart M of this part which (d)(1)(iii) of this section), in writing identifies the microorganism and its within 15 working days of the time the designated significant new uses, or person develops knowledge that the re- (2) That the recipient has knowledge cipient is engaging in a significant new of the specific section in subpart M of use, that the recipient is engaging in a this part which identifies the micro- significant new use without submitting organism and its designated significant a MCAN. new uses, or (ii) That, within 15 working days of (3) That the recipient cannot under- notifying the recipient as described in take any significant new use described paragraph (d)(1)(i) of this section, the in the specific section in subpart M of person received from the recipient, in this part. writing, a statement of assurance that (b) The manufacturer, importer, or the recipient is aware of the terms of processor described in paragraph (a) of the applicable section in subpart M of this section must submit a MCAN this part and will not engage in the sig- under subpart D of this part, if such nificant new use. person has knowledge at the time of (iii) That the person has promptly commercial distribution of the micro- provided EPA enforcement authorities

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with a copy of the recipient’s state- part M of this part which identifies the ment of assurance described in para- microorganism, and the person re- graph (d)(1)(ii) of this section. The copy ceives written notification of compli- must be sent to the Director, Office of ance from EPA prior to the effective Compliance (2221A), Environmental date of such section. The MCAN sub- Protection Agency, 1200 Pennsylvania mitter must comply with any applica- Ave., NW., Washington, DC 20460. ble requirement of section 5(b) of the (2) If EPA notifies the manufacturer, Act. The MCAN must include the infor- importer, or processor that the recipi- mation and test data specified in sec- ent is engaging in a significant new use tion 5(d)(1) of the Act. For purposes of after providing the statement of assur- this exemption, the specific section in ance described in paragraph (d)(1)(ii) of subpart M of this part which identifies this section and without submitting a the microorganism and §§ 725.3, 725.15, MCAN under this part, the manufacturer, importer, or processor shall im- 725.65, 725.70, 725.75, 725.100, and 725.900 mediately cease distribution to that reapply; after the effective date of the cipient until the manufacturer, im- section in subpart M of this part which porter, or processor or the recipient identifies the microorganism, §§ 725.105 has submitted a MCAN under this part and 725.910 apply and § 725.920 continues and the MCAN review period has ended. to apply. EPA will provide the MCAN (3) If, after receiving a statement of submitter with written notification of assurance from a recipient under para- compliance only if one of the following graph (d)(1)(ii) of this section, a manu- occurs: facturer, importer, or processor has (1) EPA is unable to make the finding knowledge that the recipient is engag- that the activities described in the ing in a significant new use without MCAN will or may present an unrea- submitting a MCAN under this part, sonable risk of injury to health or the the manufacturer, importer, or proc- environment under reasonably foresee- essor must immediately cease distrib- able circumstances, or uting the microorganism to that re- (2) EPA and the person negotiate a cipient and notify EPA enforcement consent order under section 5(e) of the authorities at the address identified in Act, such order to take effect on the ef- paragraph (d)(1)(iii) of this section. The fective date of the section in subpart M manufacturer, importer, or processor of this part which identifies the micro- may not resume distribution to that recipient until any one of the following organism. has occurred: (b) The person is operating under the (i) The manufacturer, importer, or terms of a consent order issued under processor has submitted a MCAN under section 5(e) of the Act applicable to this part and the MCAN review period that person. If a provision of such sec- has ended. tion 5(e) order is inconsistent with a (ii) The recipient has submitted a specific significant new use identified MCAN under this part and the MCAN in subpart M of this part, abiding by review period has ended. the provision of the section 5(e) order (iii) The manufacturer, importer, or exempts the person from submitting a processor has received notice from EPA MCAN for that specific significant new enforcement authorities that it may use. resume distribution to that recipient. § 725.920 Exports and imports. § 725.912 Exemptions. (a) Exports. Persons who intend to ex- Persons identified in § 725.105(c) are port a microorganism identified in sub- not required to submit a MCAN under part M of this part, or in any proposed subpart D of this part for a microorga- rule which would amend subpart M of nism identified in subpart M of this this part, are subject to the export no- part, unless otherwise specified in a specific section in subpart M, if: tification provisions of section 12(b) of (a) The person submits a MCAN for the Act. The regulations that interpret the microorganism prior to the pro- section 12(b) appear at part 707 of this mulgation date of the section in subchapter.

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(b) Imports. Persons who import a use of either: specific measures to con- substance identified in a specific sec- trol worker exposure to or release of tion in subpart M of this part are sub- microorganisms which are identified in ject to the import certification re- such sections, or alternative measures quirements under section 13 of the Act, to control worker exposure or environ- which are codified at 19 CFR §§ 12.118 mental release which EPA has deter- through 12.127 and 127.28(i). The EPA mined provide substantially the same policy in support of the import certifi- degree of protection as the specified cation requirements appears at part 707 control measures. Persons who manu- of this chapter. facture, import, or process a microorganism identified in such sections § 725.950 Additional recordkeeping re- and who intend to employ alternative quirements. measures to control worker exposure Persons submitting a MCAN for a or environmental release must submit significant new use of a microorganism a request to EPA for a determination must comply with the recordkeeping of equivalency before commencing requirements of § 725.65. In addition, manufacture, import, or processing in- the following requirements apply: volving the alternative control meas- (a) At the time EPA adds a micro- ures. organism to subpart M of this part, (b) Persons submitting a request for EPA may specify appropriate record- a determination of equivalency to EPA keeping requirements. Each manufac- under this part, unless allowed by turer, importer, and processor of the § 725.25(c) (1), (2), or (3), must submit microorganism shall maintain the the request to EPA via EPA’s Central records for 3 years from the date of Data Exchange (CDX) using EPA-pro- their creation. vided e-PMN software in the manner (b) The records required to be main- set forth in § 725.25(c). See 40 CFR tained under this section may include 720.40(a)(2)(iv) for information on how the following: to obtain e-PMN software. Support (1) Records documenting the informa- documents related to these requests tion contained in the MCAN submitted must also be submitted to EPA via to EPA. (2) Records documenting the manu- CDX using e-PMN software. If sub- facture and importation volume of the mitted on paper, requests must be sub- microorganism and the corresponding mitted either via U.S. mail to the Doc- dates of manufacture and import. ument Control Office (DCO) (7407M), (3) Records documenting volumes of Office of Pollution Prevention and the microorganism purchased domesti- Toxics, Environmental Protection cally by processors of the microorga- Agency, 1200 Pennsylvania Ave., NW., nism, names and addresses of suppliers Washington, DC 20460–0001; ATTN: and corresponding dates of purchase. SNUR Equivalency Determination or (4) Records documenting the names submitted via courier to the Environ- and addresses (including shipment des- mental Protection Agency, OPPT Doc- tination address, if different) of all per- ument Control Office (DCO), EPA East sons outside the site of manufacture or Bldg., 1201 Constitution Ave., NW., Rm. import to whom the manufacturer, im- 6428, Washington, DC 20004; ATTN: porter, or processor directly sells or SNUR Equivalency Determination. Op- transfers the microorganism, the date tical discs containing electronic re- of each sale or transfer, and the quan- quests must be submitted by courier to tity of the microorganism sold or the Environmental Protection Agency, transferred on such date. OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., § 725.975 EPA approval of alternative NW., Rm. 6428, Washington, DC 20004; control measures. ATTN: SNUR Equivalency Determina- (a) In certain sections of subpart M of tion. A request for a determination of this part, significant new uses for the equivalency must contain: identified microorganisms are de- (1) The name of the submitter. scribed as the failure to establish and (2) The specific identity of the micro- implement programs providing for the organism.

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(3) The citation for the specific sec- § 725.980 Expedited procedures for tion in subpart M of this part which issuing significant new use rules for pertains to the microorganism for microorganisms subject to section which the request is being submitted. 5(e) orders. (4) A detailed description of the ac- (a) Selection of microorganisms. (1) In tivities involved. accordance with the expedited process (5) The specifications of the alter- specified in this section, EPA will issue native worker exposure control meas- significant new use notification re- ures or environmental release control quirements for each new microorga- measures. nism that, after MCAN review under (6) A detailed analysis explaining subpart D of this part, becomes subject why such alternative control measures to a final order issued under section provide substantially the same degree 5(e) of the Act, except for an order that of protection as the specific control prohibits manufacture and import of measures identified in the specific sec- the microorganism, unless EPA deter- tion in subpart M of this part which mines that significant new use notifi- pertains to the microorganism for cation requirements are not needed for which the request is being submitted. the microorganism. (7) The data and information de- (2) If EPA determines that signifi- scribed in §§ 725.155 and 725.160. If such cant new use notifications require- data and information have already ments are not needed for a microorga- been submitted to EPA’s Office of Pol- nism that is subject to a final order lution Prevention and Toxics, the sub- issued under section 5(e) of the Act, mitter need only document that it was EPA will issue a notice in the FEDERAL previously submitted, to whom, and REGISTER explaining why the signifi- the date it was submitted. cant new use requirements are not (c) Requests for determinations of needed. equivalency will be reviewed by EPA (b) Designation of requirements. (1) The within 45 days. Determinations under significant new use notification and this paragraph will be made by the Di- other specific requirements will be rector, or a designee. Notice of the re- based on and be consistent with the sults of such determinations will be provisions included in the final order mailed to the submitter. issued for the microorganism under section 5(e) of the Act. EPA may also (d) If EPA notifies the submitter designate additional activities as sig- under paragraph (c) of this section that nificant new uses which will be subject EPA has determined that the alter- to notification. native control measures provide sub- (2) Significant new use requirements stantially the same degree of protec- and other specific requirements des- tion as the specified control measures ignated under this section will be listed identified in the specific section of sub- in subpart M of this part. For each part M of this part which pertains to microorganism, subpart M of this part the microorganism for which the re- will identify: quest is being submitted, the submitter (i) The microorganism name. may commence manufacture, import, (ii) The activities designated as sig- or processing in accordance with the nificant new uses. specifications for alternative worker (iii) Other specific requirements ap- exposure control measures or environ- plicable to the microorganism, includ- mental release control measures iden- ing recordkeeping requirements or any tified in the submitter’s request, and other requirements included in the may alter any corresponding notifica- final section 5(e) order. tion to workers to reflect such alter- (c) Procedures for issuing significant native controls. Deviations from the new use rules—(1) Possible processes. activities described in the EPA notifi- EPA will issue significant new use cation constitute a significant new use rules (SNURs) under this section by and are subject to the requirements of one of the following three processes: di- this part. rect final rulemaking, interim final [62 FR 17932, April 11, 1997, as amended at 75 rulemaking, or notice and comment FR 790, Jan. 6, 2010] rulemaking. EPA will use the direct

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final rulemaking process to issue sig- rule. If notice is received within 30 nificant new use rules unless it deter- days that someone wishes to submit mines that, in a particular case, one of adverse or critical comments, the sec- the other processes is more appro- tion(s) of the direct final rule con- priate. taining the SNUR(s) for which a notice (2) Notice in the Federal Register. FED- of intent to comment was received will ERAL REGISTER documents issued to be withdrawn by EPA issuing a docu- propose or establish significant new ment in the final rule section of the uses under this section will contain the FEDERAL REGISTER, and a proposal will following: be published in the proposed rule sec- (i) The microorganism identity or, if tion of the FEDERAL REGISTER. The pro- its specific identity is claimed con- posal will establish a 30–day comment fidential, an appropriate generic micro- period. organism name and an accession num- (iii) If EPA, having considered any ber assigned by EPA. timely comments submitted in re- (ii) The MCAN number. (iii) A summary of EPA’s findings sponse to the proposal, decides to es- under section 5(e)(1)(A) of the Act for tablish notification requirements the final order issued under section under this section, EPA will issue a 5(e). final rule adding the microorganism to (iv) Designation of the significant subpart M of this part and designating new uses subject to, or proposed to be the significant new uses subject to no- subject to, notification and any other tification. applicable requirements. (4) Interim final rulemaking. (i) EPA (v) Any modification of subpart L of will use the interim final rulemaking this part applicable to the specific procedure to issue a significant new microorganism and significant new use rule, when specific requirements uses. will be based on and be consistent with (vi) If the FEDERAL REGISTER docu- the provisions included in the final ment establishes a final rule, or noti- order issued for the microorganism fies the public that a final rule will not under section 5(e) of the Act. The be issued after public comment has Agency will issue an interim final rule been received, the document will de- in the FEDERAL REGISTER following its scribe comments received and EPA’s decision to develop a significant new response. use rule for a specific new microorga- (3) Direct final rulemaking. (i) EPA nism. The document will state EPA’s will use direct final rulemaking to reasons for using the interim final issue a significant new use rule, when rulemaking procedure. specific requirements will be based on (A) The significant new use rule will and be consistent with the provisions take effect on the date of publication. included in the final order issued for (B) Persons will be given 30 days from the microorganism under section 5(e) the date of publication to submit com- of the Act. EPA will issue a final rule ments. in the FEDERAL REGISTER following its decision to develop a significant new (ii) Interim final rules issued under use rule under this section for a spe- this section shall cease to be in effect cific new microorganism. 180 days after publication unless, with- (ii) The FEDERAL REGISTER document in the 180–day period, EPA issues a will state that, unless written notice is final rule in the FEDERAL REGISTER re- received by EPA within 30 days of pub- sponding to any written comments re- lication that someone wishes to submit ceived during the 30–day comment pe- adverse or critical comments, the rule riod specified in paragraph (c)(4)(i)(B) will be effective 60 days from the date of this section and promulgating final of publication. The written notice of significant new use notification re- intent to submit adverse or critical quirements and other requirements for comments should state which SNUR(s) the microorganism. will be the subject of the adverse or (5) Notice and comment rulemaking. (i) critical comments, if several SNURs EPA will use a notice and comment are established through the direct final procedure to issue a significant new

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use rule, when EPA is designating addi- other agency has taken action under tional activities which are not provi- another law, for the microorganism sions included in the final order issued that eliminates the need for significant for the microorganism under section new use notification under section 5(e) of the Act as significant new uses 5(a)(2) of the Act. which will be subject to notification. (3) EPA has received MCANs for some EPA will issue a proposal in the FED- or all of the activities designated as ERAL REGISTER following its decision to significant new uses of the microorga- develop a significant new use rule nism and, after reviewing such MCANs, under this section for a specific new concluded that there is no need to re- microorganism. Persons will be given quire additional notice from persons 30 days to comment on whether EPA who propose to engage in identical or should establish notification require- similar activities. ments for the microorganism under (4) EPA has examined new informa- this part. tion, or has reexamined the test data (ii) If EPA, having considered any or other information supporting its timely comments, decides to establish finding under section 5(e)(1)(A)(ii)(I) of notification requirements under this the Act and has concluded that a ra- section, EPA will issue a final rule add- tional basis no longer exists for the ing the microorganism to subpart M of findings that activities involving the this part and designating the signifi- microorganism may present an unrea- cant new uses subject to notification. sonable risk of injury to health or the (d) Schedule for issuing significant new environment required under section use rules. (1) Unless EPA determines 5(e)(1)(A) of the Act. that a significant new use rule should (5) Certain activities involving the not be issued under this section, EPA microorganism have been designated as will issue a proposed rule, a direct final significant new uses pending the com- rule, or an interim final rule within 180 pletion of testing, and adequate test days of receipt of a valid notice of com- data developed in accordance with ap- mencement under § 725.190. plicable procedures and criteria have (2) If EPA receives adverse or critical been submitted to EPA. significant comments following publi- (b) Procedures for limitation or revoca- cation of a proposed or interim final tion. Modification or revocation of sig- rule, EPA will either withdraw the rule nificant new use notification require- or issue a final rule addressing the ments for a microorganism that has comments received. been added to subpart M of this part using the procedures described in § 725.984 Modification or revocation of § 725.980 may occur either at EPA’s ini- certain notification requirements. tiative or in response to a written re- (a) Criteria for modification or revoca- quest. tion. EPA may at any time modify or (1) Any affected person may request revoke significant new use notification modification or revocation of signifi- requirements for a microorganism cant new use notification requirements which has been added to subpart M of for a microorganism that has been this part using the procedures of added to subpart M of this part using § 725.980. Such action may be taken the procedures described in § 725.980 by under this section if EPA makes one of writing to the Director, or a designee, the following determinations, unless and stating the basis for such request. other information shows that the re- The request must be accompanied by quirements should be retained: information sufficient to support the (1) Test data or other information ob- request. Persons submitting a request tained by EPA provide a reasonable to EPA under this part, unless allowed basis for concluding that activities des- by § 725.25(c)(1), (c)(2), or (c)(3), must ignated as significant new uses of the submit the request to EPA via EPA’s microorganism will not present an un- Central Data Exchange (CDX) using reasonable risk of injury to health or EPA-provided e-PMN reporting soft- the environment. ware in the manner set forth in (2) EPA has promulgated a rule under § 725.25(c). See 40 CFR 720.40(a)(2)(iv) for section 4 or 6 of the Act, or EPA or an- information on how to obtain the e-

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PMN software. Support documents re- § 725.1075 Burkholderia cepacia com- lated to these requests must also be plex. submitted to EPA via CDX using e- (a) Microorganism and significant new PMN software. Paper requests must be uses subject to reporting. (1) The micro- submitted either via U.S. mail to the organisms identified as the Document Control Office (DCO) Burkholderia cepacia complex defined as (7407M), Office of Pollution Prevention containing the following nine species, and Toxics, Environmental Protection Burkholderia cepacia, Burkholderia Agency, 1200 Pennsylvania Ave., NW., multivorans, Burkholderia stabilis, Washington, DC 20460–0001; ATTN: Re- Burkholderia vietnamiensis, Burkholderia quest to Amend SNUR or submitted via ambifaria, Burkholderia pyrrocinia, courier to the Environmental Protec- Burkholderia cepacia genomovar VIII tion Agency, OPPT Document Control (Burkholderia anthina), and Office (DCO), EPA East Bldg., 1201 Con- Burkholderia cepacia genomovars III stitution Ave., NW., Rm. 6428, Wash- and VI are subject to reporting under ington, DC 20004; ATTN: Request to this section for the significant new Amend SNUR. Optical discs containing uses described in paragraph (a)(2) of electronic requests must be submitted this section. by courier to the Environmental Pro- (2) The significant new use is any use tection Agency, OPPT Document Con- other than research and development trol Office (DCO), EPA East Bldg., 1201 in the degradation of chemicals via in- Constitution Ave., NW., Rm. 6428, jection into subsurface groundwater. Washington, DC 20004; ATTN: Request (b) [Reserved] to Amend SNUR. (2) The Director, or a designee, will [68 FR 35320, June 13, 2003] consider the request, make a determination whether to initiate rule- PART 745—LEAD-BASED PAINT POI- making to modify the requirements, SONING PREVENTION IN CER- and notify the requester of that deter- TAIN RESIDENTIAL STRUCTURES mination by certified letter. If the request is denied, the letter will explain Subparts A–C [Reserved] why EPA has concluded that the significant new use notification require- Subpart D—Lead-Based Paint Hazards ments for that microorganism should remain in effect. 745.61 Scope and applicability. (3) If EPA concludes that significant 745.63 Definitions. 745.65 Lead-based paint hazards. new use notification requirements for a microorganism should be limited or re- Subpart E—Residential Property Renovation voked, EPA will propose the changes in a notice in the FEDERAL REGISTER, Sec. briefly describe the grounds for the ac- 745.80 Purpose. tion, and provide interested parties an 745.81 Effective dates. opportunity to comment. 745.82 Applicability. 745.83 Definitions. [62 FR 17932, April 11, 1997, as amended at 75 745.84 Information distribution require- FR 790, Jan. 6, 2010] ments. 745.85 Work practice standards. Subpart M—Significant New Uses 745.86 Recordkeeping and reporting requirements. for Specific Microorganisms 745.87 Enforcement and inspections. § 725.1000 Scope. 745.88 Recognized test kits. 745.89 Firm certification. This subpart identifies uses of micro- 745.90 Renovator certification and dust organisms which EPA has determined sampling technician certification. to be significant new uses under the 745.91 Suspending, revoking, or modifying authority of section 5(a)(2) of the Toxic an individual’s or firm’s certification. Substances Control Act.

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745.92 Fees for the accreditation of renova- 745.324 Authorization of State or Tribal pro- tion and dust sampling technician train- grams. ing and the certification of renovation 745.325 Lead-based paint activities: State firms. and Tribal program requirements. 745.326 Renovation: State and Tribal pro- Subpart F—Disclosure of Known Lead- gram requirements. Based Paint and/or Lead-Based Paint 745.327 State or Indian Tribal lead-based Hazards Upon Sale or Lease of Resi- paint compliance and enforcement pro- dential Property grams. 745.339 Effective date. 745.100 Purpose. 745.101 Scope and applicability. AUTHORITY: 15 U.S.C. 2605, 2607, 2681–2692 745.102 Effective dates. and 42 U.S.C. 4852d. 745.103 Definitions. 745.107 Disclosure requirements for sellers SOURCE: 61 FR 9085, Mar. 6, 1996, unless oth- and lessors. erwise noted. 745.110 Opportunity to conduct an evaluation. 745.113 Certification and acknowledgment Subparts A–C [Reserved] of disclosure. 745.115 Agent responsibilities. Subpart D—Lead-Based Paint 745.118 Enforcement. Hazards 745.119 Impact on State and local requirements. SOURCE: 66 FR 1237, Jan. 5, 2001, unless oth- Subparts G–K [Reserved] erwise noted.

Subpart L—Lead-Based Paint Activities § 745.61 Scope and applicability. 745.220 Scope and applicability. (a) This subpart identifies lead-based 745.223 Definitions. paint hazards. 745.225 Accreditation of training programs: (b) The standards for lead-based paint target housing and child-occupied facilities. hazards apply to target housing and 745.226 Certification of individuals and child-occupied facilities. firms engaged in lead-based paint activi- (c) Nothing in this subpart requires ties: target housing and child-occupied the owner of property(ies) subject to facilities. these standards to evaluate the prop- 745.227 Work practice standards for conducting lead-based paint activities: tar- erty(ies) for the presence of lead-based get housing and child-occupied facilities. paint hazards or take any action to 745.228 Accreditation of training programs: control these conditions if one or more public and commercial buildings, bridges of them is identified. and superstructures. [Reserved] 745.229 Certification of individuals and § 745.63 Definitions. firms engaged in lead-based paint activities: public and commercial buildings, The following definitions apply to bridges and superstructures. [Reserved] part 745. 745.230 Work practice standards for con- Arithmetic mean means the algebraic ducting lead-based paint activities: pub- sum of data values divided by the num- lic and commercial buildings, bridges and superstructures. [Reserved] ber of data values (e.g., the sum of the 745.233 Lead-based paint activities require- concentration of lead in several soil ments. samples divided by the number of sam- 745.235 Enforcement. ples). 745.237 Inspections. Chewable surface means an interior or 745.238 Fees for accreditation and certifi- exterior surface painted with lead- cation of lead-based paint activities. 745.239 Effective dates. based paint that a young child can mouth or chew. A chewable surface is Subparts M–P [Reserved] the same as an ‘‘accessible surface’’ as defined in 42 U.S.C. 4851b(2)). Hard Subpart Q—State and Indian Tribal metal substrates and other materials Programs that cannot be dented by the bite of a 745.320 Scope and purpose. young child are not considered 745.323 Definitions. chewable.

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Common area group means a group of dren’s possessions, observations of play common areas that are similar in de- patterns, or information provided by sign, construction, and function. Com- parents, residents, care givers, or prop- mon area groups include, but are not erty owners. limited to hallways, stairwells, and Residential building means a building laundry rooms. containing one or more residential Concentration means the relative con- dwellings. tent of a specific substance contained Room means a separate part of the in- within a larger mass, such as the side of a building, such as a bedroom, amount of lead (in micrograms per living room, dining room, kitchen, gram or parts per million by weight) in bathroom, laundry room, or utility a sample of dust or soil. room. To be considered a separate Deteriorated paint means any interior room, the room must be separated from or exterior paint or other coating that adjoining rooms by built-in walls or is peeling, chipping, chalking or crack- archways that extend at least 6 inches ing, or any paint or coating located on from an intersecting wall. Half walls or an interior or exterior surface or fix- bookcases count as room separators if ture that is otherwise damaged or sepa- built-in. Movable or collapsible parti- rated from the substrate. tions or partitions consisting solely of Dripline means the area within 3 feet shelves or cabinets are not considered surrounding the perimeter of a build- built-in walls. A screened in porch that ing. is used as a living area is a room. Friction surface means an interior or Soil sample means a sample collected exterior surface that is subject to abra- in a representative location using sion or friction, including, but not lim- ASTM E1727, ‘‘Standard Practice for ited to, certain window, floor, and stair Field Collection of Soil Samples for surfaces. Lead Determination by Atomic Spec- Impact surface means an interior or trometry Techniques,’’ or equivalent exterior surface that is subject to dam- method. age by repeated sudden force such as Weighted arithmetic mean means the certain parts of door frames. arithmetic mean of sample results Interior window sill means the portion weighted by the number of subsamples of the horizontal window ledge that in each sample. Its purpose is to give protrudes into the interior of the room. influence to a sample relative to the Lead-based paint hazard means haz- surface area it represents. A single sur- ardous lead-based paint, dust-lead haz- face sample is comprised of a single ard or soil-lead hazard as identified in subsample. A composite sample may § 745.65. contain from two to four subsamples of Loading means the quantity of a spe- the same area as each other and of cific substance present per unit of sur- each single surface sample in the com- face area, such as the amount of lead in posite. The weighted arithmetic mean micrograms contained in the dust col- is obtained by summing, for all sam- lected from a certain surface area di- ples, the product of the sample’s result vided by the surface area in square feet multiplied by the number of subsam- or square meters. ples in the sample, and dividing the Mid-yard means an area of a residen- sum by the total number of subsamples tial yard approximately midway be- contained in all samples. For example, tween the dripline of a residential the weighted arithmetic mean of a sin- building and the nearest property gle surface sample containing 60 μg/ft2, boundary or between the driplines of a a composite sample (three subsamples) residential building and another build- containing 100 μg/ft2, and a composite ing on the same property. sample (4 subsamples) containing 110 Play area means an area of frequent μg/ft2 is 100 μg/ft2. This result is based soil contact by children of less than 6 on the equation [60+(3*100)+(4*110)]/ years of age as indicated by, but not (1+3+4). limited to, such factors including the Window trough means, for a typical following: the presence of play equip- double-hung window, the portion of the ment (e.g., sandboxes, swing sets, and exterior window sill between the inte- sliding boards), toys, or other chil- rior window sill (or stool) and the

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frame of the storm window. If there is parts per million of bare soil in the rest no storm window, the window trough is of the yard based on soil samples. the area that receives both the upper (d) Work practice requirements. Appli- and lower window sashes when they are cable certification, occupant protec- both lowered. The window trough is tion, and clearance requirements and sometimes referred to as the window work practice standards are found in ‘‘well.’’ regulations issued by EPA at 40 CFR Wipe sample means a sample collected part 745, subpart L and in regulations by wiping a representative surface of issued by the Department of Housing known area, as determined by ASTM and Urban Development (HUD) at 24 E1728, ‘‘Standard Practice for Field CFR part 35, subpart R. The work prac- Collection of Settled Dust Samples tice standards in those regulations do Using Wipe Sampling Methods for Lead not apply when treating paint-lead haz- Determination by Atomic Spectrom- ards of less than: etry Techniques, or equivalent method, (1) Two square feet of deteriorated with an acceptable wipe material as de- lead-based paint per room or equiva- fined in ASTM E 1792, ‘‘Standard Speci- lent, fication for Wipe Sampling Materials (2) Twenty square feet of deteriorated for Lead in Surface Dust.’’ paint on the exterior building, or (3) Ten percent of the total surface § 745.65 Lead-based paint hazards. area of deteriorated paint on an inte- (a) Paint-lead hazard. A paint-lead rior or exterior type of component with hazard is any of the following: a small surface area. (1) Any lead-based paint on a friction surface that is subject to abrasion and Subpart E—Residential Property where the lead dust levels on the near- Renovation est horizontal surface underneath the friction surface (e.g., the window sill, SOURCE: 63 FR 29919, June 1, 1998, unless or floor) are equal to or greater than otherwise noted. the dust-lead hazard levels identified in paragraph (b) of this section. § 745.80 Purpose. (2) Any damaged or otherwise dete- This subpart contains regulations de- riorated lead-based paint on an impact veloped under sections 402 and 406 of surface that is caused by impact from a the Toxic Substances Control Act (15 related building component (such as a U.S.C. 2682 and 2686) and applies to all door knob that knocks into a wall or a renovations performed for compensa- door that knocks against its door tion in target housing and child-occu- frame. pied facilities. The purpose of this sub- (3) Any chewable lead-based painted part is to ensure the following: surface on which there is evidence of (a) Owners and occupants of target teeth marks. housing and child-occupied facilities (4) Any other deteriorated lead-based receive information on lead-based paint in any residential building or paint hazards before these renovations child-occupied facility or on the exte- begin; and rior of any residential building or (b) Individuals performing renova- child-occupied facility. tions regulated in accordance with (b) Dust-lead hazard. A dust-lead haz- § 745.82 are properly trained; renovators ard is surface dust in a residential and firms performing these renovations dwelling or child-occupied facility that are certified; and the work practices in contains a mass-per-area concentration § 745.85 are followed during these ren- μ 2 of lead equal to or exceeding 40 g/ft ovations. on floors or 250 μg/ft2 on interior window sills based on wipe samples. [73 FR 21758, Apr. 22, 2008] (c) Soil-lead hazard. A soil-lead hazard is bare soil on residential real property § 745.81 Effective dates. or on the property of a child-occupied (a) Training, certification and accredi- facility that contains total lead equal tation requirements and work practice to or exceeding 400 parts per million standards. The training, certification (μg/g) in a play area or average of 1,200 and accreditation requirements and

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work practice standards in this subpart safe work practices contained in EPA’s are applicable in any State or Indian renovation, repair, and painting rule. Tribal area that does not have a ren- For the purposes of this section, a child ovation program that is authorized resides in the primary residence of his under subpart Q of this part. The train- or her custodial parents, legal guard- ing, certification and accreditation re- ians, and foster parents. A child also quirements and work practice stand- resides in the primary residence of an ards in this subpart will become effec- informal caretaker if the child lives tive as follows: and sleeps most of the time at the care- (1) Training programs. Effective June taker’s residence. 23, 2008, no training program may pro- (ii) On or after July 6, 2010, all ren- vide, offer, or claim to provide training ovations must be performed in accord- or refresher training for EPA certifi- ance with the work practice standards cation as a renovator or a dust sam- in § 745.85 and the associated record- pling technician without accreditation keeping requirements in § 745.86(b)(1) from EPA under § 745.225. Training pro- and (b)(6) in target housing or child-oc- grams may apply for accreditation cupied facilities, unless the renovation under § 745.225 beginning April 22, 2009. qualifies for the exception identified in (2) Firms. (i) Firms may apply for cer- § 745.82(a). tification under § 745.89 beginning Octo- (5) The suspension and revocation ber 22, 2009. (ii) On or after April 22, 2010, no firm provisions in § 745.91 are effective April may perform, offer, or claim to per- 22, 2010. form renovations without certification (b) Renovation-specific pamphlet. Be- from EPA under § 745.89 in target hous- fore December 22, 2008, renovators or ing or child-occupied facilities, unless firms performing renovations in States the renovation qualifies for one of the and Indian Tribal areas without an au- exceptions identified in § 745.82(a) or thorized program may provide owners (c). and occupants with either of the fol- (3) Individuals. On or after April 22, lowing EPA pamphlets: Protect Your 2010, all renovations must be directed Family From Lead in Your Home or Ren- by renovators certified in accordance ovate Right: Important Lead Hazard In- with § 745.90(a) and performed by cer- formation for Families, Child Care Pro- tified renovators or individuals trained viders and Schools. After that date, Ren- in accordance with § 745.90(b)(2) in tar- ovate Right: Important Lead Hazard In- get housing or child-occupied facilities, formation for Families, Child Care Pro- unless the renovation qualifies for one viders and Schools must be used exclu- of the exceptions identified in sively. § 745.82(a) or (c). (c) Pre-Renovation Education Rule. (4) Work practices. (i) On or after April With the exception of the requirement 22, 2010 and before July 6, 2010 all ren- to use the pamphlet entitled Renovate ovations must be performed in accord- Right: Important Lead Hazard Informa- ance with the work practice standards tion for Families, Child Care Providers in § 745.85 and the associated record- and Schools, the provisions of the Pre- keeping requirements in § 745.86 (b)(6) Renovation Education Rule in this sub- in target housing or child-occupied fa- part have been in effect since June cilities, unless the renovation qualifies 1999. for one of the exceptions identified in § 745.82(a). This does not apply to ren- [73 FR 21758, Apr. 22, 2008, as amended at 75 ovations in target housing for which FR 24818, May 6, 2010] the firm performing the renovation has § 745.82 Applicability. obtained a statement signed by the owner that the renovation will occur in (a) This subpart applies to all renova- the owner’s residence, no child under tions performed for compensation in age 6 resides there, the housing is not target housing and child-occupied fa- a child-occupied facility, and the owner cilities, except for the following: acknowledges that the work practices (1) Renovations in target housing or to be used during the renovation will child-occupied facilities in which a not necessarily include all of the lead- written determination has been made

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by an inspector or risk assessor (cer- and the recordkeeping requirements of tified pursuant to either Federal regu- § 745.86(b)(6) and (b)(7). lations at § 745.226 or a State or Tribal [73 FR 21758, Apr. 22, 2008, as amended at 75 certification program authorized pur- FR 24818, May 6, 2010] suant to § 745.324) that the components affected by the renovation are free of § 745.83 Definitions. paint or other surface coatings that For purposes of this part, the defini- contain lead equal to or in excess of 1.0 tions in § 745.103 as well as the fol- milligrams/per square centimeter (mg/ lowing definitions apply: cm2) or 0.5% by weight, where the firm Administrator means the Adminis- performing the renovation has ob- trator of the Environmental Protection tained a copy of the determination. Agency. (2) Renovations in target housing or Child-occupied facility means a build- child-occupied facilities in which a cer- ing, or portion of a building, con- tified renovator, using an EPA recog- structed prior to 1978, visited regularly nized test kit as defined in § 745.83 and by the same child, under 6 years of age, following the kit manufacturer’s in- on at least two different days within structions, has tested each component any week (Sunday through Saturday affected by the renovation and deter- period), provided that each day’s visit mined that the components are free of lasts at least 3 hours and the combined paint or other surface coatings that weekly visits last at least 6 hours, and contain lead equal to or in excess of 1.0 the combined annual visits last at least mg/cm2 or 0.5% by weight. If the com- 60 hours. Child-occupied facilities may ponents make up an integrated whole, include, but are not limited to, day such as the individual stair treads and care centers, preschools and kinder- risers of a single staircase, the ren- garten classrooms. Child-occupied fa- ovator is required to test only one of cilities may be located in target hous- the individual components, unless the ing or in public or commercial build- individual components appear to have ings. With respect to common areas in been repainted or refinished sepa- public or commercial buildings that rately. contain child-occupied facilities, the (b) The information distribution re- child-occupied facility encompasses quirements in § 745.84 do not apply to only those common areas that are rou- emergency renovations, which are ren- tinely used by children under age 6, ovation activities that were not such as restrooms and cafeterias. Com- planned but result from a sudden, un- mon areas that children under age 6 expected event (such as non-routine only pass through, such as hallways, failures of equipment) that, if not im- stairways, and garages are not in- mediately attended to, presents a safe- cluded. In addition, with respect to ex- ty or public health hazard, or threatens teriors of public or commercial build- equipment and/or property with signifi- ings that contain child-occupied facili- cant damage. Interim controls per- ties, the child-occupied facility encom- formed in response to an elevated blood passes only the exterior sides of the lead level in a resident child are also building that are immediately adjacent emergency renovations. Emergency to the child-occupied facility or the renovations other than interim con- common areas routinely used by chil- trols are also exempt from the warning dren under age 6. sign, containment, waste handling, Cleaning verification card means a training, and certification require- card developed and distributed, or oth- ments in §§ 745.85, 745.89, and 745.90 to erwise approved, by EPA for the pur- the extent necessary to respond to the pose of determining, through compari- emergency. Emergency renovations are son of wet and dry disposable cleaning not exempt from the cleaning require- cloths with the card, whether post-ren- ments of § 745.85(a)(5), which must be ovation cleaning has been properly performed by certified renovators or completed. individuals trained in accordance with Component or building component § 745.90(b)(2), the cleaning verification means specific design or structural ele- requirements of § 745.85(b), which must ments or fixtures of a building or resi- be performed by certified renovators, dential dwelling that are distinguished

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from each other by form, function, and Minor repair and maintenance activities location. These include, but are not are activities, including minor heating, limited to, interior components such ventilation or air conditioning work, as: Ceilings, crown molding, walls, electrical work, and plumbing, that chair rails, doors, door trim, floors, disrupt 6 square feet or less of painted fireplaces, radiators and other heating surface per room for interior activities units, shelves, shelf supports, stair or 20 square feet or less of painted sur- treads, stair risers, stair stringers, face for exterior activities where none newel posts, railing caps, balustrades, of the work practices prohibited or re- windows and trim (including sashes, stricted by § 745.85(a)(3) are used and window heads, jambs, sills or stools where the work does not involve win- and troughs), built in cabinets, col- dow replacement or demolition of umns, beams, bathroom vanities, painted surface areas. When removing counter tops, and air conditioners; and painted components, or portions of exterior components such as: Painted painted components, the entire surface roofing, chimneys, flashing, gutters area removed is the amount of painted and downspouts, ceilings, soffits, fas- surface disturbed. Jobs, other than cias, rake boards, cornerboards, bulk- emergency renovations, performed in heads, doors and door trim, fences, the same room within the same 30 days floors, joists, lattice work, railings and must be considered the same job for railing caps, siding, handrails, stair ris- the purpose of determining whether the ers and treads, stair stringers, col- job is a minor repair and maintenance umns, balustrades, windowsills or activity. stools and troughs, casings, sashes and Pamphlet means the EPA pamphlet wells, and air conditioners. titled Renovate Right: Important Lead Dry disposable cleaning cloth means a Hazard Information for Families, Child commercially available dry, electro- Care Providers and Schools developed statically charged, white disposable under section 406(a) of TSCA for use in cloth designed to be used for cleaning complying with section 406(b) of TSCA, hard surfaces such as uncarpeted floors or any State or Tribal pamphlet ap- or counter tops. proved by EPA pursuant to 40 CFR Firm means a company, partnership, corporation, sole proprietorship or in- 745.326 that is developed for the same dividual doing business, association, or purpose. This includes reproductions of other business entity; a Federal, State, the pamphlet when copied in full and Tribal, or local government agency; or without revision or deletion of mate- a nonprofit organization. rial from the pamphlet (except for the HEPA vacuum means a vacuum clean- addition or revision of State or local er which has been designed with a high- sources of information). Before Decem- efficiency particulate air (HEPA) filter ber 22, 2008, the term ‘‘pamphlet’’ also as the last filtration stage. A HEPA fil- means any pamphlet developed by EPA ter is a filter that is capable of cap- under section 406(a) of TSCA or any turing particles of 0.3 microns with State or Tribal pamphlet approved by 99.97% efficiency. The vacuum cleaner EPA pursuant to § 745.326. must be designed so that all the air Person means any natural or judicial drawn into the machine is expelled person including any individual, cor- through the HEPA filter with none of poration, partnership, or association; the air leaking past it. any Indian Tribe, State, or political Interim controls means a set of meas- subdivision thereof; any interstate ures designed to temporarily reduce body; and any department, agency, or human exposure or likely exposure to instrumentality of the Federal Govern- lead-based paint hazards, including ment. specialized cleaning, repairs, mainte- Recognized test kit means a commer- nance, painting, temporary contain- cially available kit recognized by EPA ment, ongoing monitoring of lead- under § 745.88 as being capable of allow- based paint hazards or potential haz- ing a user to determine the presence of ards, and the establishment and oper- lead at levels equal to or in excess of ation of management and resident edu- 1.0 milligrams per square centimeter, cation programs. or more than 0.5% lead by weight, in a

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paint chip, paint powder, or painted Work area means the area that the surface. certified renovator establishes to con- Renovation means the modification of tain the dust and debris generated by a any existing structure, or portion renovation. thereof, that results in the disturbance of painted surfaces, unless that activ- [63 FR 29919, June 1, 1998, as amended at 73 FR 21758, Apr. 22, 2008] ity is performed as part of an abatement as defined by this part (40 CFR § 745.84 Information distribution re- 745.223). The term renovation includes quirements. (but is not limited to): The removal, modification or repair of painted sur- (a) Renovations in dwelling units. No faces or painted components (e.g., more than 60 days before beginning modification of painted doors, surface renovation activities in any residential restoration, window repair, surface dwelling unit of target housing, the preparation activity (such as sanding, firm performing the renovation must: scraping, or other such activities that (1) Provide the owner of the unit with may generate paint dust)); the removal the pamphlet, and comply with one of of building components (e.g., walls, the following: ceilings, plumbing, windows); weather- (i) Obtain, from the owner, a written ization projects (e.g., cutting holes in acknowledgment that the owner has painted surfaces to install blown-in in- received the pamphlet. sulation or to gain access to attics, (ii) Obtain a certificate of mailing at planing thresholds to install weather- least 7 days prior to the renovation. stripping), and interim controls that (2) In addition to the requirements in disturb painted surfaces. A renovation paragraph (a)(1) of this section, if the performed for the purpose of con- owner does not occupy the dwelling verting a building, or part of a build- unit, provide an adult occupant of the ing, into target housing or a child-oc- unit with the pamphlet, and comply cupied facility is a renovation under with one of the following: this subpart. The term renovation does (i) Obtain, from the adult occupant, a not include minor repair and mainte- written acknowledgment that the oc- nance activities. cupant has received the pamphlet; or Renovator means an individual who certify in writing that a pamphlet has either performs or directs workers who been delivered to the dwelling and that perform renovations. A certified ren- the firm performing the renovation has ovator is a renovator who has success- been unsuccessful in obtaining a writ- fully completed a renovator course ac- ten acknowledgment from an adult oc- credited by EPA or an EPA-authorized cupant. Such certification must in- State or Tribal program. clude the address of the unit under- Training hour means at least 50 minutes of actual learning, including, but going renovation, the date and method not limited to, time devoted to lecture, of delivery of the pamphlet, names of learning activities, small group activi- the persons delivering the pamphlet, ties, demonstrations, evaluations, and reason for lack of acknowledgment hands-on experience. (e.g., occupant refuses to sign, no adult Wet disposable cleaning cloth means a occupant available), the signature of a commercially available, pre-moistened representative of the firm performing white disposable cloth designed to be the renovation, and the date of signa- used for cleaning hard surfaces such as ture. uncarpeted floors or counter tops. (ii) Obtain a certificate of mailing at Wet mopping system means a device least 7 days prior to the renovation. with the following characteristics: A (b) Renovations in common areas. No long handle, a mop head designed to be more than 60 days before beginning used with disposable absorbent clean- renovation activities in common areas ing pads, a reservoir for cleaning solu- of multi-unit target housing, the firm tion, and a built-in mechanism for dis- performing the renovation must: tributing or spraying the cleaning solu- (1) Provide the owner with the pam- tion onto a floor, or a method of equiv- phlet, and comply with one of the fol- alent efficacy. lowing:

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(i) Obtain, from the owner, a written beyond that which was described in the acknowledgment that the owner has original notice. received the pamphlet. (c) Renovations in child-occupied facili- (ii) Obtain a certificate of mailing at ties. No more than 60 days before begin- least 7 days prior to the renovation. ning renovation activities in any child- (2) Comply with one of the following. (i) occupied facility, the firm performing Notify in writing, or ensure written no- the renovation must: tification of, each affected unit and (1)(i) Provide the owner of the build- make the pamphlet available upon re- ing with the pamphlet, and comply quest prior to the start of renovation. with one of the following: Such notification shall be accom- (A) Obtain, from the owner, a written plished by distributing written notice acknowledgment that the owner has to each affected unit. The notice shall received the pamphlet. describe the general nature and loca- (B) Obtain a certificate of mailing at tions of the planned renovation activi- least 7 days prior to the renovation. ties; the expected starting and ending (ii) If the child-occupied facility is dates; and a statement of how the oc- not the owner of the building, provide cupant can obtain the pamphlet and a an adult representative of the child-oc- copy of the records required by cupied facility with the pamphlet, and § 745.86(c) and (d), at no cost to the oc- comply with one of the following: cupants, or (A) Obtain, from the adult representative, a written acknowledgment that (ii) While the renovation is ongoing, the adult representative has received post informational signs describing the the pamphlet; or certify in writing that general nature and locations of the a pamphlet has been delivered to the renovation and the anticipated comple- facility and that the firm performing tion date. These signs must be posted the renovation has been unsuccessful in areas where they are likely to be in obtaining a written acknowledgment seen by the occupants of all of the af- from an adult representative. Such cer- fected units. The signs must be accom- tification must include the address of panied by a posted copy of the pam- the child-occupied facility undergoing phlet or information on how interested renovation, the date and method of de- occupants can review a copy of the livery of the pamphlet, names of the pamphlet or obtain a copy from the persons delivering the pamphlet, rea- renovation firm at no cost to occu- son for lack of acknowledgment (e.g., pants. The signs must also include in- representative refuses to sign), the sig- formation on how interested occupants nature of a representative of the firm can review a copy of the records re- performing the renovation, and the quired by § 745.86(c) and (d) or obtain a date of signature. copy from the renovation firm at no (B) Obtain a certificate of mailing at cost to the occupants. least 7 days prior to the renovation. (3) Prepare, sign, and date a state- (2) Provide the parents and guardians ment describing the steps performed to of children using the child-occupied fa- notify all occupants of the intended cility with the pamphlet, information renovation activities and to provide describing the general nature and loca- the pamphlet. tions of the renovation and the antici- (4) If the scope, locations, or expected pated completion date, and informa- starting and ending dates of the tion on how interested parents or planned renovation activities change guardians of children frequenting the after the initial notification, and the child-occupied facility can review a firm provided written initial notifica- copy of the records required by tion to each affected unit, the firm per- § 745.86(c) and (d) or obtain a copy from forming the renovation must provide the renovation firm at no cost to the further written notification to the occupants by complying with one of owners and occupants providing revised the following: information on the ongoing or planned (i) Mail or hand-deliver the pamphlet activities. This subsequent notification and the renovation information to each must be provided before the firm per- parent or guardian of a child using the forming the renovation initiates work child-occupied facility.

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(ii) While the renovation is ongoing, as directed in § 745.89. The responsibil- post informational signs describing the ities of certified firms are set forth in general nature and locations of the § 745.89(d) and the responsibilities of renovation and the anticipated comple- certified renovators are set forth in tion date. These signs must be posted § 745.90(b). in areas where they can be seen by the (1) Occupant protection. Firms must parents or guardians of the children post signs clearly defining the work frequenting the child-occupied facility. area and warning occupants and other The signs must be accompanied by a persons not involved in renovation ac- posted copy of the pamphlet or infor- tivities to remain outside of the work mation on how interested parents or area. To the extent practicable, these guardians of children frequenting the child-occupied facility can review a signs must be in the primary language copy of the pamphlet or obtain a copy of the occupants. These signs must be from the renovation firm at no cost to posted before beginning the renovation the parents or guardians. The signs and must remain in place and readable must also include information on how until the renovation and the post-ren- interested parents or guardians of chil- ovation cleaning verification have been dren frequenting the child-occupied fa- completed. If warning signs have been cility can review a copy of the records posted in accordance with 24 CFR required by § 745.86(c) and (d) or obtain 35.1345(b)(2) or 29 CFR 1926.62(m), addi- a copy from the renovation firm at no tional signs are not required by this cost to the parents or guardians. section. (3) The renovation firm must prepare, (2) Containing the work area. Before sign, and date a statement describing beginning the renovation, the firm the steps performed to notify all par- must isolate the work area so that no ents and guardians of the intended ren- dust or debris leaves the work area ovation activities and to provide the while the renovation is being per- pamphlet. formed. In addition, the firm must (d) Written acknowledgment. The writ- maintain the integrity of the contain- ten acknowledgments required by para- ment by ensuring that any plastic or graphs (a)(1)(i), (a)(2)(i), (b)(1)(i), other impermeable materials are not (c)(1)(i)(A), and (c)(1)(ii)(A) of this sec- torn or displaced, and taking any other tion must: steps necessary to ensure that no dust (1) Include a statement recording the or debris leaves the work area while owner or occupant’s name and ac- the renovation is being performed. The knowledging receipt of the pamphlet firm must also ensure that contain- prior to the start of renovation, the ad- ment is installed in such a manner that dress of the unit undergoing renova- it does not interfere with occupant and tion, the signature of the owner or occupant as applicable, and the date of worker egress in an emergency. signature. (i) Interior renovations. The firm (2) Be either a separate sheet or part must: of any written contract or service (A) Remove all objects from the work agreement for the renovation. area, including furniture, rugs, and (3) Be written in the same language window coverings, or cover them with as the text of the contract or agree- plastic sheeting or other impermeable ment for the renovation or, in the case material with all seams and edges of non-owner occupied target housing, taped or otherwise sealed. in the same language as the lease or (B) Close and cover all ducts opening rental agreement or the pamphlet. in the work area with taped-down plas- [63 FR 29919, June 1, 1998. Redesignated and tic sheeting or other impermeable ma- amended at 73 FR 21760, Apr. 22, 2008; 75 FR terial. 24818, May 6, 2010] (C) Close windows and doors in the work area. Doors must be covered with § 745.85 Work practice standards. plastic sheeting or other impermeable (a) Standards for renovation activities. material. Doors used as an entrance to Renovations must be performed by cer- the work area must be covered with tified firms using certified renovators plastic sheeting or other impermeable

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material in a manner that allows work- blasting, or sandblasting, is prohibited ers to pass through while confining unless such machines are used with dust and debris to the work area. HEPA exhaust control. (D) Cover the floor surface, including (iii) Operating a heat gun on lead- installed carpet, with taped-down plas- based paint is permitted only at tem- tic sheeting or other impermeable ma- peratures below 1100 degrees Fahr- terial in the work area 6 feet beyond enheit. the perimeter of surfaces undergoing (4) Waste from renovations—(i) Waste renovation or a sufficient distance to from renovation activities must be contain the dust, whichever is greater. contained to prevent releases of dust (E) Use precautions to ensure that all and debris before the waste is removed personnel, tools, and other items, including the exteriors of containers of from the work area for storage or dis- waste, are free of dust and debris before posal. If a chute is used to remove leaving the work area. waste from the work area, it must be (ii) Exterior renovations. The firm covered. must: (ii) At the conclusion of each work (A) Close all doors and windows with- day and at the conclusion of the ren- in 20 feet of the renovation. On multi- ovation, waste that has been collected story buildings, close all doors and from renovation activities must be windows within 20 feet of the renova- stored under containment, in an enclo- tion on the same floor as the renova- sure, or behind a barrier that prevents tion, and close all doors and windows release of dust and debris out of the on all floors below that are the same work area and prevents access to dust horizontal distance from the renova- and debris. tion. (iii) When the firm transports waste (B) Ensure that doors within the from renovation activities, the firm work area that will be used while the must contain the waste to prevent re- job is being performed are covered with lease of dust and debris. plastic sheeting or other impermeable (5) Cleaning the work area. After the material in a manner that allows work- renovation has been completed, the ers to pass through while confining firm must clean the work area until no dust and debris to the work area. (C) Cover the ground with plastic dust, debris or residue remains. sheeting or other disposable imper- (i) Interior and exterior renovations. meable material extending 10 feet be- The firm must: yond the perimeter of surfaces under- (A) Collect all paint chips and debris going renovation or a sufficient dis- and, without dispersing any of it, seal tance to collect falling paint debris, this material in a heavy-duty bag. whichever is greater, unless the prop- (B) Remove the protective sheeting. erty line prevents 10 feet of such Mist the sheeting before folding it, fold ground covering. the dirty side inward, and either tape (D) In certain situations, the renova- shut to seal or seal in heavy-duty bags. tion firm must take extra precautions Sheeting used to isolate contaminated in containing the work area to ensure rooms from non-contaminated rooms that dust and debris from the renova- must remain in place until after the tion does not contaminate other build- cleaning and removal of other sheeting. ings or other areas of the property or Dispose of the sheeting as waste. migrate to adjacent properties. (ii) Additional cleaning for interior ren- (3) Prohibited and restricted practices. ovations. The firm must clean all ob- The work practices listed below shall jects and surfaces in the work area and be prohibited or restricted during a renovation as follows: within 2 feet of the work area in the (i) Open-flame burning or torching of following manner, cleaning from high- lead-based paint is prohibited. er to lower: (ii) The use of machines that remove (A) Walls. Clean walls starting at the lead-based paint through high speed op- ceiling and working down to the floor eration such as sanding, grinding, by either vacuuming with a HEPA vac- power planing, needle gun, abrasive uum or wiping with a damp cloth.

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(B) Remaining surfaces. Thoroughly (B) Wipe uncarpeted floors and vacuum all remaining surfaces and ob- countertops within the work area with jects in the work area, including fur- a wet disposable cleaning cloth. Floors niture and fixtures, with a HEPA vacu- must be wiped using an application de- um. The HEPA vacuum must be vice with a long handle and a head to equipped with a beater bar when which the cloth is attached. The cloth vacuuming carpets and rugs. must remain damp at all times while it (C) Wipe all remaining surfaces and is being used to wipe the surface for objects in the work area, except for post-renovation cleaning verification. carpeted or upholstered surfaces, with If the surface within the work area is a damp cloth. Mop uncarpeted floors greater than 40 square feet, the surface thoroughly, using a mopping method within the work area must be divided that keeps the wash water separate into roughly equal sections that are from the rinse water, such as the 2- each less than 40 square feet. Wipe each bucket mopping method, or using a wet such section separately with a new wet mopping system. disposable cleaning cloth. If the cloth (b) Standards for post-renovation clean- used to wipe each section of the surface ing verification—(1) Interiors. (i) A cer- within the work area matches the tified renovator must perform a visual cleaning verification card, the surface inspection to determine whether dust, has been adequately cleaned. debris or residue is still present. If (1) If the cloth used to wipe a par- dust, debris or residue is present, these ticular surface section does not match conditions must be removed by re- the cleaning verification card, re-clean cleaning and another visual inspection that section of the surface as directed must be performed. in paragraphs (a)(5)(ii)(B) and (ii) After a successful visual inspec- (a)(5)(ii)(C) of this section, then use a tion, a certified renovator must: new wet disposable cleaning cloth to (A) Verify that each windowsill in wipe that section again. If the cloth the work area has been adequately matches the cleaning verification card, cleaned, using the following procedure. that section of the surface has been (1) Wipe the windowsill with a wet adequately cleaned. disposable cleaning cloth that is damp (2) If the cloth used to wipe a par- to the touch. If the cloth matches or is ticular surface section does not match lighter than the cleaning verification the cleaning verification card after the card, the windowsill has been ade- surface has been re-cleaned, wait for 1 quately cleaned. hour or until the entire surface within (2) If the cloth does not match and is the work area has dried completely, darker than the cleaning verification whichever is longer. card, re-clean the windowsill as di- (3) After waiting for the entire sur- rected in paragraphs (a)(5)(ii)(B) and face within the work area to dry, wipe (a)(5)(ii)(C) of this section, then either each section of the surface that has not use a new cloth or fold the used cloth yet achieved post-renovation cleaning in such a way that an unused surface is verification with a dry disposable exposed, and wipe the surface again. If cleaning cloth. After this wipe, that the cloth matches or is lighter than section of the surface has been ade- the cleaning verification card, that quately cleaned. windowsill has been adequately (iii) When the work area passes the cleaned. post-renovation cleaning verification, (3) If the cloth does not match and is remove the warning signs. darker than the cleaning verification (2) Exteriors. A certified renovator card, wait for 1 hour or until the sur- must perform a visual inspection to deface has dried completely, whichever is termine whether dust, debris or residue longer. is still present on surfaces in and below (4)After waiting for the windowsill to the work area, including windowsills dry, wipe the windowsill with a dry dis- and the ground. If dust, debris or res- posable cleaning cloth. After this wipe, idue is present, these conditions must the windowsill has been adequately be eliminated and another visual in- cleaned. spection must be performed. When the

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area passes the visual inspection, re- lations at § 745.226 or an EPA-author- move the warning signs. ized State or Tribal certification pro- (c) Optional dust clearance testing. gram). Cleaning verification need not be per- (ii) Records prepared by a certified formed if the contract between the ren- renovator after using EPA-recognized ovation firm and the person con- test kits, including an identification of tracting for the renovation or another the manufacturer and model of any Federal, State, Territorial, Tribal, or test kits used, a description of the local law or regulation requires: components that were tested including (1) The renovation firm to perform their locations, and the result of each dust clearance sampling at the conclu- test kit used. sion of a renovation covered by this (2) Signed and dated acknowledg- subpart. ments of receipt as described in (2) The dust clearance samples are re- § 745.84(a)(1)(i), (a)(2)(i), (b)(1)(i), quired to be collected by a certified in- (c)(1)(i)(A), and (c)(1)(ii)(A). spector, risk assessor or dust sampling technician. (3) Certifications of attempted deliv- (3) The renovation firm is required to ery as described in § 745.84(a)(2)(i) and re-clean the work area until the dust (c)(1)(ii)(A). clearance sample results are below the (4) Certificates of mailing as de- clearance standards in § 745.227(e)(8) or scribed in § 745.84(a)(1)(ii), (a)(2)(ii), any applicable State, Territorial, Trib- (b)(1)(ii), (c)(1)(i)(B), and (c)(1)(ii)(B). al, or local standard. (5) Records of notification activities (d) Activities conducted after post-ren- performed regarding common area renovation cleaning verification. Activities ovations, as described in § 745.84(b)(3) that do not disturb paint, such as ap- and (b)(4), and renovations in child-oc- plying paint to walls that have already cupied facilities, as described in been prepared, are not regulated by § 745.84(c)(2). this subpart if they are conducted after (6) Documentation of compliance post-renovation cleaning verification with the requirements of § 745.85, in- has been performed. cluding documentation that a certified [73 FR 21761, Apr. 22, 2008] renovator was assigned to the project, that the certified renovator provided § 745.86 Recordkeeping and reporting on-the-job training for workers used on requirements. the project, that the certified ren- (a) Firms performing renovations ovator performed or directed workers must retain and, if requested, make who performed all of the tasks de- available to EPA all records necessary scribed in § 745.85(a), and that the cer- to demonstrate compliance with this tified renovator performed the post- subpart for a period of 3 years fol- renovation cleaning verification de- lowing completion of the renovation. scribed in § 745.85(b). If the renovation This 3–year retention requirement does firm was unable to comply with all of not supersede longer obligations re- the requirements of this rule due to an quired by other provisions for retaining emergency as defined in § 745.82, the the same documentation, including any firm must document the nature of the applicable State or Tribal laws or regu- emergency and the provisions of the lations. rule that were not followed. This docu- (b) Records that must be retained mentation must include a copy of the pursuant to paragraph (a) of this sec- certified renovator’s training certifi- tion shall include (where applicable): cate, and a certification by the cer- (1) Records or reports certifying that tified renovator assigned to the project a determination had been made that that: lead-based paint was not present on the (i) Training was provided to workers components affected by the renovation, (topics must be identified for each as described in § 745.82(a). These records worker). or reports include: (ii) Warning signs were posted at the (i) Reports prepared by a certified in- entrances to the work area. spector or certified risk assessor (cer- (iii) If test kits were used, that the tified pursuant to either Federal regu- specified brand of kits was used at the

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specified locations and that the results tion, whichever is earlier, the renova- were as specified. tion firm must provide information (iv) The work area was contained by: pertaining to compliance with this sub- (A) Removing or covering all objects part to the following persons: in the work area (interiors). (i) The owner of the building; and, if (B) Closing and covering all HVAC different, ducts in the work area (interiors). (ii) An adult occupant of the residen- (C) Closing all windows in the work tial dwelling, if the renovation took area (interiors) or closing all windows place within a residential dwelling, or in and within 20 feet of the work area an adult representative of the child-oc- (exteriors). cupied facility, if the renovation took (D) Closing and sealing all doors in the work area (interiors) or closing and place within a child-occupied facility. sealing all doors in and within 20 feet (2) When performing renovations in of the work area (exteriors). common areas of multi-unit target (E) Covering doors in the work area housing, renovation firms must post that were being used to allow passage the information required by this sub- but prevent spread of dust. part or instructions on how interested (F) Covering the floor surface, in- occupants can obtain a copy of this including installed carpet, with taped- formation. This information must be down plastic sheeting or other imper- posted in areas where it is likely to be meable material in the work area 6 feet seen by the occupants of all of the af- beyond the perimeter of surfaces un- fected units. dergoing renovation or a sufficient dis- (3) The information required to be tance to contain the dust, whichever is provided by paragraph (c) of this sec- greater (interiors) or covering the tion may be provided by completing ground with plastic sheeting or other the sample form titled ‘‘Sample Ren- disposable impermeable material an- ovation Recordkeeping Checklist’’ or a chored to the building extending 10 feet similar form containing the test kit in- beyond the perimeter of surfaces un- formation required by § 745.86(b)(1)(ii) dergoing renovation or a sufficient dis- and the training and work practice tance to collect falling paint debris, compliance information required by whichever is greater, unless the prop- § 745.86(b)(6). erty line prevents 10 feet of such ground covering, weighted down by (d) If dust clearance sampling is per- heavy objects (exteriors). formed in lieu of cleaning verification (G) Installing (if necessary) vertical as permitted by § 745.85(c), the renova- containment to prevent migration of tion firm must provide, when the final dust and debris to adjacent property invoice for the renovation is delivered (exteriors). or within 30 days of the completion of (v) Waste was contained on-site and the renovation, whichever is earlier, a while being transported off-site. copy of the dust sampling report to: (vi) The work area was properly (1) The owner of the building; and, if cleaned after the renovation by: different, (A) Picking up all chips and debris, (2) An adult occupant of the residen- misting protective sheeting, folding it tial dwelling, if the renovation took dirty side inward, and taping it for replace within a residential dwelling, or moval. an adult representative of the child-oc- (B) Cleaning the work area surfaces cupied facility, if the renovation took and objects using a HEPA vacuum and/ place within a child-occupied facility. or wet cloths or mops (interiors). (3) When performing renovations in (vii) The certified renovator per- common areas of multi-unit target formed the post-renovation cleaning verification (the results of which must housing, renovation firms must post be briefly described, including the these dust sampling reports or infor- number of wet and dry cloths used). mation on how interested occupants of (c)(1) When the final invoice for the the housing being renovated can obtain renovation is delivered or within 30 a copy of the report. This information days of the completion of the renova- must be posted in areas where they are

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likely to be seen by the occupants of the following website for information all of the affected units. on where to apply: http://www.epa.gov/ etv/howtoapply.html. [73 FR 21761, Apr. 22, 2008, as amended at 75 FR 24819, May 6, 2010] (2) After the kit has been tested through the Environmental Tech- § 745.87 Enforcement and inspections. nology Verification Program or other (a) Failure or refusal to comply with equivalent approved EPA testing pro- any provision of this subpart is a viola- gram, EPA will review the report to de- tion of TSCA section 409 (15 U.S.C. termine whether the required criteria 2689). have been met. (b) Failure or refusal to establish and (3) Before September 1, 2010, test kits maintain records or to make available must meet only the negative response or permit access to or copying of criteria in paragraph (c)(1) of this sec- records, as required by this subpart, is tion. The recognition of kits that meet a violation of TSCA sections 15 and 409 only this criteria will last until EPA (15 U.S.C. 2614 and 2689). publicizes its recognition of the first (c) Failure or refusal to permit entry test kits that meets both of the cri- or inspection as required by 40 CFR teria in paragraph (c) of this section. 745.87 and TSCA section 11 (15 U.S.C. (4) After September 1, 2010, test kits 2610) is a violation of sections 15 and must meet both of the criteria in para- 409 (15 U.S.C. 2614 and 2689). graph (c) of this section. (d) Violators may be subject to civil (5) If the report demonstrates that and criminal sanctions pursuant to the kit meets the required criteria, TSCA section 16 (15 U.S.C. 2615) for EPA will issue a notice of recognition each violation. to the kit manufacturer, provide them (e) Lead-based paint is assumed to be with the report, and post the informa- present at renovations covered by this tion on EPA’s website. subpart. EPA may conduct inspections (6) If the report demonstrates that and issue subpoenas pursuant to the the kit does not meet the required cri- provisions of TSCA section 11 (15 U.S.C. teria, EPA will notify the kit manufac- 2610) to ensure compliance with this turer and provide them with the re- subpart. port. (c) Response criteria—(1) Negative re- [63 FR 29919, June 1, 1998, as amended at 73 sponse criteria. For paint containing FR 21763, Apr. 22, 2008] lead at or above the regulated level, 1.0 2 § 745.88 Recognized test kits. mg/cm or 0.5% by weight, a demonstrated probability (with 95% con- (a) Effective June 23, 2008, EPA rec- fidence) of a negative response less ognizes the test kits that have been de- than or equal to 5% of the time. termined by National Institute of (2) Positive response criteria. For paint Standards and Technology research to containing lead below the regulated meet the negative response criteria de- level, 1.0 mg/cm2 or 0.5% by weight, a scribed in paragraph (c)(1) of this sec- demonstrated probability (with 95% tion. This recognition will last until confidence) of a positive response less EPA publicizes its recognition of the than or equal to 10% of the time. first test kit that meets both the negative response and positive response cri- [73 FR 21763, Apr. 22, 2008] teria in paragraph (c) of this section. (b) No other test kits will be recog- § 745.89 Firm certification. nized until they are tested through (a) Initial certification. (1) Firms that EPA’s Environmental Technology perform renovations for compensation Verification Program or other equiva- must apply to EPA for certification to lent EPA approved testing program. perform renovations or dust sampling. (1) Effective September 1, 2008, to ini- To apply, a firm must submit to EPA a tiate the testing process, a test kit completed ‘‘Application for Firms,’’ manufacturer must submit a sufficient signed by an authorized agent of the number of kits, along with the instruc- firm, and pay at least the correct tions for using the kits, to EPA. The amount of fees. If a firm pays more test kit manufacturer should first visit than the correct amount of fees, EPA

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will reimburse the firm for the excess cation. A complete application for re- amount. certification includes a completed (2) After EPA receives a firm’s appli- ‘‘Application for Firms’’ which con- cation, EPA will take one of the fol- tains all of the information requested lowing actions within 90 days of the by the form and is signed by an author- date the application is received: ized agent of the firm, noting on the (i) EPA will approve a firm’s applica- form that it is submitted as a re-cer- tion if EPA determines that it is com- tification. A complete application plete and that the environmental com- must also include at least the correct pliance history of the firm, its prin- amount of fees. If a firm pays more cipals, or its key employees does not than the correct amount of fees, EPA show an unwillingness or inability to will reimburse the firm for the excess maintain compliance with environ- amount. mental statutes or regulations. An ap- (i) An application for re-certification plication is complete if it contains all is timely if it is postmarked 90 days or of the information requested on the more before the date the firm’s current form and includes at least the correct certification expires. If the firm’s ap- amount of fees. When EPA approves a plication is complete and timely, the firm’s application, EPA will issue the firm’s current certification will remain firm a certificate with an expiration in effect until its expiration date or date not more than 5 years from the until EPA has made a final decision to date the application is approved. EPA approve or disapprove the re-certifi- certification allows the firm to per- cation application, whichever is later. form renovations covered by this sec- (ii) If the firm submits a complete re- tion in any State or Indian Tribal area certification application less than 90 that does not have a renovation pro- days before its current certification ex- gram that is authorized under subpart pires, and EPA does not approve the Q of this part. application before the expiration date, (ii) EPA will request a firm to supple- the firm’s current certification will ex- ment its application if EPA determines pire and the firm will not be able to that the application is incomplete. If conduct renovations until EPA ap- EPA requests a firm to supplement its proves its re-certification application. application, the firm must submit the (iii) If the firm fails to obtain recer- requested information or pay the addi- tification before the firm’s current cer- tional fees within 30 days of the date of tification expires, the firm must not the request. perform renovations or dust sampling (iii) EPA will not approve a firm’s ap- until it is certified anew pursuant to plication if the firm does not supple- paragraph (a) of this section. ment its application in accordance (2) EPA action on an application. After with paragraph (a)(2)(ii) of this section EPA receives a firm’s application for or if EPA determines that the environ- re-certification, EPA will review the mental compliance history of the firm, application and take one of the fol- its principals, or its key employees lowing actions within 90 days of re- demonstrates an unwillingness or in- ceipt: ability to maintain compliance with (i) EPA will approve a firm’s applica- environmental statutes or regulations. tion if EPA determines that it is time- EPA will send the firm a letter giving ly and complete and that the environ- the reason for not approving the appli- mental compliance history of the firm, cation. EPA will not refund the appli- its principals, or its key employees cation fees. A firm may reapply for cer- does not show an unwillingness or in- tification at any time by filing a new, ability to maintain compliance with complete application that includes the environmental statutes or regulations. correct amount of fees. When EPA approves a firm’s applica- (b) Re-certification. To maintain its tion for re-certification, EPA will issue certification, a firm must be re-cer- the firm a new certificate with an expi- tified by EPA every 5 years. ration date 5 years from the date that (1) Timely and complete application. To the firm’s current certification expires. be re-certified, a firm must submit a EPA certification allows the firm to complete application for re-certifi- perform renovations or dust sampling

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covered by this section in any State or (2) A certified renovator is assigned Indian Tribal area that does not have a to each renovation performed by the renovation program that is authorized firm and discharges all of the certified under subpart Q of this part. renovator responsibilities identified in (ii) EPA will request a firm to supple- § 745.90. ment its application if EPA determines (3) All renovations performed by the that the application is incomplete. firm are performed in accordance with (iii) EPA will not approve a firm’s ap- the work practice standards in § 745.85. plication if it is not received or is not (4) The pre-renovation education re- complete as of the date that the firm’s quirements of § 745.84 have been per- current certification expires, or if EPA formed. determines that the environmental (5) The recordkeeping requirements compliance history of the firm, its of § 745.86 are met. principals, or its key employees dem- [73 FR 21764, Apr. 22, 2008] onstrates an unwillingness or inability to maintain compliance with environ- § 745.90 Renovator certification and mental statutes or regulations. EPA dust sampling technician certifi- will send the firm a letter giving the cation. reason for not approving the applica- (a) Renovator certification and dust tion. EPA will not refund the applica- sampling technician certification. (1) To tion fees. A firm may reapply for cer- become a certified renovator or certification at any time by filing a new tified dust sampling technician, an in- application and paying the correct dividual must successfully complete amount of fees. the appropriate course accredited by (c) Amendment of certification. A firm EPA under § 745.225 or by a State or must amend its certification within 90 Tribal program that is authorized days of the date a change occurs to in- under subpart Q of this part. The formation included in the firm’s most course completion certificate serves as recent application. If the firm fails to proof of certification. EPA renovator amend its certification within 90 days certification allows the certified indi- of the date the change occurs, the firm vidual to perform renovations covered may not perform renovations or dust by this section in any State or Indian sampling until its certification is Tribal area that does not have a ren- amended. ovation program that is authorized (1) To amend a certification, a firm under subpart Q of this part. EPA dust must submit a completed ‘‘Application sampling technician certification al- for Firms,’’ signed by an authorized lows the certified individual to perform agent of the firm, noting on the form dust clearance sampling under that it is submitted as an amendment § 745.85(c) in any State or Indian Tribal and indicating the information that area that does not have a renovation has changed. The firm must also pay at program that is authorized under sub- least the correct amount of fees. part Q of this part. (2) If additional information is need- (2) Individuals who have successfully ed to process the amendment, or the completed an accredited abatement firm did not pay the correct amount of worker or supervisor course, or individ- fees, EPA will request the firm to sub- uals who have successfully completed mit the necessary information or fees. an EPA, HUD, or EPA/HUD model ren- The firm’s certification is not amended ovation training course may take an until the firm complies with the re- accredited refresher renovator training quest. course in lieu of the initial renovator (3) Amending a certification does not training course to become a certified affect the certification expiration date. renovator. (d) Firm responsibilities. Firms per- (3) Individuals who have successfully forming renovations must ensure that: completed an accredited lead-based (1) All individuals performing renova- paint inspector or risk assessor course tion activities on behalf of the firm are may take an accredited refresher dust either certified renovators or have been sampling technician course in lieu of trained by a certified renovator in ac- the initial training to become a cer- cordance with § 745.90. tified dust sampling technician.

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(4) To maintain renovator certifi- pletion certificate and their most re- cation or dust sampling technician cer- cent refresher course completion certification, an individual must complete tificate. a renovator or dust sampling techni- (8) Must prepare the records required cian refresher course accredited by by § 745.86(b)(1) and (b)(6). EPA under § 745.225 or by a State or (c) Dust sampling technician respon- Tribal program that is authorized sibilities. When performing optional under subpart Q of this part within 5 dust clearance sampling under years of the date the individual com- § 745.85(c), a certified dust sampling pleted the initial course described in technician: paragraph (a)(1) of this section. If the (1) Must collect dust samples in ac- individual does not complete a re- cordance with § 745.227(e)(8), must send fresher course within this time, the in- the collected samples to a laboratory dividual must re-take the initial recognized by EPA under TSCA section course to become certified again. Indi- 405(b), and must compare the results to viduals who complete a renovator the clearance levels in accordance with course accredited by EPA before April § 745.227(e)(8). 22, 2010, must complete an EPA-accred- (2) Must have with them at the work ited renovator refresher course before site copies of their initial course com- July 1, 2015, to maintain renovator cer- pletion certificate and their most re- tification. cent refresher course completion cer- (b) Renovator responsibilities. Certified tificate. renovators are responsible for ensuring [73 FR 21765, Apr. 22, 2008, as amended at 75 compliance with § 745.85 at all renova- FR 24819, May 6, 2010] tions to which they are assigned. A certified renovator: § 745.91 Suspending, revoking, or (1) Must perform all of the tasks de- modifying an individual’s or firm’s scribed in § 745.85(b) and must either certification. perform or direct workers who perform (a)(1) Grounds for suspending, revok- all of the tasks described in § 745.85(a). ing, or modifying an individual’s certifi- (2) Must provide training to workers cation. EPA may suspend, revoke, or on the work practices they will be modify an individual’s certification if using in performing their assigned the individual fails to comply with tasks. Federal lead-based paint statutes or (3) Must be physically present at the regulations. EPA may also suspend, rework site when the signs required by voke, or modify a certified renovator’s § 745.85(a)(1) are posted, while the work certification if the renovator fails to area containment required by ensure that all assigned renovations § 745.85(a)(2) is being established, and comply with § 745.85. In addition to an while the work area cleaning required administrative or judicial finding of by § 745.85(a)(5) is performed. violation, execution of a consent agree- (4) Must regularly direct work being ment in settlement of an enforcement performed by other individuals to en- action constitutes, for purposes of this sure that the work practices are being section, evidence of a failure to comply followed, including maintaining the in- with relevant statutes or regulations. tegrity of the containment barriers and (2) Grounds for suspending, revoking, or ensuring that dust or debris does not modifying a firm’s certification. EPA may spread beyond the work area. suspend, revoke, or modify a firm’s cer- (5) Must be available, either on-site tification if the firm: or by telephone, at all times that ren- (i) Submits false or misleading infor- ovations are being conducted. mation to EPA in its application for (6) When requested by the party con- certification or re-certification. tracting for renovation services, must (ii) Fails to maintain or falsifies use an acceptable test kit to determine records required in § 745.86. whether components to be affected by (iii) Fails to comply, or an individual the renovation contain lead-based performing a renovation on behalf of paint. the firm fails to comply, with Federal (7) Must have with them at the work lead-based paint statutes or regula- site copies of their initial course com- tions. In addition to an administrative

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or judicial finding of violation, execu- through (b)(1)(iii) of this section, ex- tion of a consent agreement in settle- plaining why it is necessary to suspend ment of an enforcement action con- the entity’s certification before an op- stitutes, for purposes of this section, portunity for a hearing. evidence of a failure to comply with (ii) Notify the affected entity of its relevant statutes or regulations. right to request a hearing on the im- (b) Process for suspending, revoking, or mediate suspension within 15 days of modifying certification. (1) Prior to tak- the suspension taking place and the ing action to suspend, revoke, or mod- procedures for the conduct of such a ify an individual’s or firm’s certifi- hearing. cation, EPA will notify the affected en- (5) Any notice, decision, or order tity in writing of the following: (i) The legal and factual basis for the issued by EPA under this section, any proposed suspension, revocation, or transcript or other verbatim record of modification. oral testimony, and any documents (ii) The anticipated commencement filed by a certified individual or firm in date and duration of the suspension, a hearing under this section will be revocation, or modification. available to the public, except as oth- (iii) Actions, if any, which the af- erwise provided by section 14 of TSCA fected entity may take to avoid sus- or by part 2 of this title. Any such pension, revocation, or modification, or hearing at which oral testimony is pre- to receive certification in the future. sented will be open to the public, ex- (iv) The opportunity and method for cept that the Presiding Officer may ex- requesting a hearing prior to final sus- clude the public to the extent nec- pension, revocation, or modification. essary to allow presentation of infor- (2) If an individual or firm requests a mation which may be entitled to con- hearing, EPA will: fidential treatment under section 14 of (i) Provide the affected entity an op- TSCA or part 2 of this title. portunity to offer written statements (6) EPA will maintain a publicly in response to EPA’s assertions of the available list of entities whose certifi- legal and factual basis for its proposed cation has been suspended, revoked, action. modified, or reinstated. (ii) Appoint an impartial official of (7) Unless the decision and order EPA as Presiding Officer to conduct the hearing. issued under paragraph (b)(3)(iii) of (3) The Presiding Officer will: this section specify otherwise: (i) Conduct a fair, orderly, and impar- (i) An individual whose certification tial hearing within 90 days of the re- has been suspended must take a request for a hearing. fresher training course (renovator or (ii) Consider all relevant evidence, dust sampling technician) in order to explanation, comment, and argument make his or her certification current. submitted. (ii) An individual whose certification (iii) Notify the affected entity in has been revoked must take an initial writing within 90 days of completion of renovator or dust sampling technician the hearing of his or her decision and course in order to become certified order. Such an order is a final agency again. action which may be subject to judicial (iii) A firm whose certification has review. The order must contain the been revoked must reapply for certifi- commencement date and duration of cation after the revocation ends in the suspension, revocation, or modi- order to become certified again. If the fication. firm’s certification has been suspended (4) If EPA determines that the public and the suspension ends less than 5 health, interest, or welfare warrants years after the firm was initially cer- immediate action to suspend the certification of any individual or firm tified or re-certified, the firm does not prior to the opportunity for a hearing, need to do anything to re-activate its it will: certification. (i) Notify the affected entity in ac- [73 FR 21765, Apr. 22, 2008] cordance with paragraph (b)(1)(i)

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§ 745.92 Fees for the accreditation of (ii) Exemption. No fee shall be im- renovation and dust sampling tech- posed on any training program oper- nician training and the certification ated by a State, federally recognized of renovation firms. Indian Tribe, local government, or non- (a) Persons who must pay fees. Fees in profit organization. This exemption accordance with paragraph (b) of this does not apply to the certification of section must be paid by: firms or individuals. (1) Training programs—(i) Non-exempt (2) Firms. All firms applying to EPA training programs. All non-exempt for certification and re-certification to training programs applying to EPA for conduct renovations. the accreditation and re-accreditation (b) Fee amounts—(1) Certification and of training programs in one or more of accreditation fees. Initial and renewal the following disciplines: Renovator, certification and accreditation fees are dust sampling technician. specified in the following table:

Re-accreditation (every 4 years, see Training Program Accreditation 40 CFR 745.225(f)(1) for details)

Initial Renovator or Dust Sampling Technician $560 $340 Course

Refresher Renovator or Dust Sampling Tech- $400 $310 nician Course

Renovation Firm Certification Re-certification (every 5 years see 40 CFR 745.89(b))

Firm $300 $300 Combined Renovation and Lead-based Paint $550 $550 Activities Firm Application Combined Renovation and Lead-based Paint $20 $20 Activities Tribal Firm Application Tribal Firm $20 $20

(2) Lost certificate. A $15 fee will be Subpart F—Disclosure of Known charged for the replacement of a firm Lead-Based Paint and/or certificate. Lead-Based Paint Hazards (c) Certificate replacement. Firms seeking certificate replacement must: Upon Sale or Lease of Resi- (1) Complete the applicable portions dential Property of the ‘‘Application for Firms’’ in ac- § 745.100 Purpose. cordance with the instructions provided. This subpart implements the provi- (2) Submit the application and a pay- sions of 42 U.S.C. 4852d, which impose ment of $15 in accordance with the in- certain requirements on the sale or structions provided with the applica- lease of target housing. Under this sub- tion package. part, a seller or lessor of target hous- (d) Failure to remit fees. (1) EPA will ing shall disclose to the purchaser or not provide certification, re-certifi- lessee the presence of any known lead- cation, accreditation, or re-accredita- based paint and/or lead-based paint tion for any firm or training program hazards; provide available records and that does not remit fees described in reports; provide the purchaser or lessee paragraph (b) of this section in accord- with a lead hazard information pam- ance with the procedures specified in 40 phlet; give purchasers a 10-day oppor- CFR 745.89. tunity to conduct a risk assessment or (2) EPA will not replace a certificate inspection; and attach specific disclo- for any firm that does not remit the $15 sure and warning language to the sales fee in accordance with the procedures or leasing contract before the pur- specified in paragraph (c) of this sec- chaser or lessee is obligated under a tion. contract to purchase or lease target [74 FR 11869, Mar. 20, 2009] housing.

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§ 745.101 Scope and applicability. ing or leasing target housing. This This subpart applies to all trans- term does not apply to purchasers or actions to sell or lease target housing, any purchaser’s representative who re- including subleases, with the exception ceives all compensation from the pur- of the following: chaser. (a) Sales of target housing at fore- Available means in the possession of closure. or reasonably obtainable by the seller (b) Leases of target housing that or lessor at the time of the disclosure. have been found to be lead-based paint Common area means a portion of a free by an inspector certified under the building generally accessible to all Federal certification program or under residents/users including, but not lim- a federally accredited State or tribal ited to, hallways, stairways, laundry certification program. Until a Federal and recreational rooms, playgrounds, certification program or federally ac- community centers, and boundary credited State certification program is fences. in place within the State, inspectors Contract for the purchase and sale of shall be considered qualified to conduct residential real property means any con- an inspection for this purpose if they tract or agreement in which one party have received certification under any agrees to purchase an interest in real existing State or tribal inspector cer- property on which there is situated one tification program. The lessor has the or more residential dwellings used or option of using the results of addi- occupied, or intended to be used or oc- tional test(s) by a certified inspector to cupied, in whole or in part, as the home confirm or refute a prior finding. or residence of one or more persons. (c) Short-term leases of 100 days or EPA means the Environmental Pro- less, where no lease renewal or exten- tection Agency. sion can occur. Evaluation means a risk assessment (d) Renewals of existing leases in tar- and/or inspection. get housing in which the lessor has pre- Foreclosure means any of the various viously disclosed all information re- methods, statutory or otherwise, quired under § 745.107 and where no new known in different jurisdictions, of en- information described in § 745.107 has forcing payment of a debt, by the tak- come into the possession of the lessor. ing and selling of real property. For the purposes of this paragraph, re- Housing for the elderly means retire- newal shall include both renegotiation ment communities or similar types of of existing lease terms and/or ratifica- housing reserved for households com- tion of a new lease. posed of one or more persons 62 years § 745.102 Effective dates. of age or more at the time of initial occupancy. The requirements in this subpart take effect in the following manner: HUD means the U.S. Department of (a) For owners of more than four resi- Housing and Urban Development. dential dwellings, the requirements Inspection means: shall take effect on September 6, 1996. (1) A surface-by-surface investigation (b) For owners of one to four residen- to determine the presence of lead-based tial dwellings, the requirements shall paint as provided in section 302(c) of take effect on December 6, 1996. the Lead-Based Paint Poisoning and Prevention Act [42 U.S.C. 4822], and § 745.103 Definitions. (2) The provision of a report explain- The following definitions apply to ing the results of the investigation. this subpart. Lead-based paint means paint or other The Act means the Residential Lead- surface coatings that contain lead Based Paint Hazard Reduction Act of equal to or in excess of 1.0 milligram 1992, 42 U.S.C. 4852d. per square centimeter or 0.5 percent by Agent means any party who enters weight. into a contract with a seller or lessor, Lead-based paint free housing means including any party who enters into a target housing that has been found to contract with a representative of the be free of paint or other surface coat- seller or lessor, for the purpose of sell- ings that contain lead equal to or in

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excess of 1.0 milligram per square cen- Risk assessment means an on-site in- timeter or 0.5 percent by weight. vestigation to determine and report Lead-based paint hazard means any the existence, nature, severity, and lo- condition that causes exposure to lead cation of lead-based paint hazards in from lead-contaminated dust, lead-con- residential dwellings, including: taminated soil, or lead-contaminated (1) Information gathering regarding paint that is deteriorated or present in the age and history of the housing and accessible surfaces, friction surfaces, occupancy by children under age 6; or impact surfaces that would result in (2) Visual inspection; adverse human health effects as estab- (3) Limited wipe sampling or other lished by the appropriate Federal agen- environmental sampling techniques; cy. (4) Other activity as may be appro- Lessee means any entity that enters priate; and into an agreement to lease, rent, or (5) Provision of a report explaining sublease target housing, including but the results of the investigation. not limited to individuals, partner- Secretary means the Secretary of ships, corporations, trusts, government Housing and Urban Development. agencies, housing agencies, Indian Seller means any entity that transfers tribes, and nonprofit organizations. legal title to target housing, in whole Lessor means any entity that offers or in part, in return for consideration, target housing for lease, rent, or sub- including but not limited to individ- lease, including but not limited to indi- uals, partnerships, corporations, viduals, partnerships, corporations, trusts, government agencies, housing trusts, government agencies, housing agencies, Indian tribes, and nonprofit agencies, Indian tribes, and nonprofit organizations. The term ‘‘seller’’ also organizations. includes: Owner means any entity that has (1) An entity that transfers shares in legal title to target housing, including a cooperatively owned project, in re- but not limited to individuals, partner- turn for consideration; and ships, corporations, trusts, government (2) An entity that transfers its inter- agencies, housing agencies, Indian est in a leasehold, in jurisdictions or tribes, and nonprofit organizations, ex- circumstances where it is legally per- cept where a mortgagee holds legal missible to separate the fee title from title to property serving as collateral the title to the improvement, in return for a mortgage loan, in which case the for consideration. owner would be the mortgagor. Target housing means any housing Purchaser means an entity that en- constructed prior to 1978, except hous- ters into an agreement to purchase an ing for the elderly or persons with dis- interest in target housing, including abilities (unless any child who is less but not limited to individuals, partner- than 6 years of age resides or is ex- ships, corporations, trusts, government pected to reside in such housing) or agencies, housing agencies, Indian any 0-bedroom dwelling. tribes, and nonprofit organizations. TSCA means the Toxic Substances Reduction means measures designed Control Act, 15 U.S.C. 2601. to reduce or eliminate human exposure 0-bedroom dwelling means any residen- to lead-based paint hazards through tial dwelling in which the living area is methods including interim controls not separated from the sleeping area. and abatement. The term includes efficiencies, studio Residential dwelling means: apartments, dormitory housing, mili- (1) A single-family dwelling, includ- tary barracks, and rentals of individual ing attached structures such as porches rooms in residential dwellings. and stoops; or (2) A single-family dwelling unit in a § 745.107 Disclosure requirements for structure that contains more than one sellers and lessors. separate residential dwelling unit, and (a) The following activities shall be in which each such unit is used or oc- completed before the purchaser or les- cupied, or intended to be used or occu- see is obligated under any contract to pied, in whole or in part, as the resi- purchase or lease target housing that dence of one or more persons. is not otherwise an exempt transaction

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pursuant to § 745.101. Nothing in this tion of lead-based paint and/or lead- section implies a positive obligation on based paint hazards in the target hous- the seller or lessor to conduct any eval- ing as a whole. uation or reduction activities. (b) If any of the disclosure activities (1) The seller or lessor shall provide identified in paragraph (a) of this sec- the purchaser or lessee with an EPA- tion occurs after the purchaser or les- approved lead hazard information pam- see has provided an offer to purchase or phlet. Such pamphlets include the EPA lease the housing, the seller or lessor document entitled Protect Your Family shall complete the required disclosure From Lead in Your Home (EPA #747-K- activities prior to accepting the pur- 94-001) or an equivalent pamphlet that chaser’s or lessee’s offer and allow the has been approved for use in that State purchaser or lessee an opportunity to by EPA. review the information and possibly (2) The seller or lessor shall disclose amend the offer. to the purchaser or lessee the presence of any known lead-based paint and/or § 745.110 Opportunity to conduct an lead-based paint hazards in the target evaluation. housing being sold or leased. The seller or lessor shall also disclose any addi- (a) Before a purchaser is obligated tional information available con- under any contract to purchase target cerning the known lead-based paint housing, the seller shall permit the and/or lead-based paint hazards, such purchaser a 10-day period (unless the as the basis for the determination that parties mutually agree, in writing, lead-based paint and/or lead-based upon a different period of time) to con- paint hazards exist, the location of the duct a risk assessment or inspection lead-based paint and/or lead-based for the presence of lead-based paint paint hazards, and the condition of the and/or lead-based paint hazards. painted surfaces. (b) Not withstanding paragraph (a) of (3) The seller or lessor shall disclose this section, a purchaser may waive to each agent the presence of any the opportunity to conduct the risk as- known lead-based paint and/or lead- sessment or inspection by so indicating based paint hazards in the target hous- in writing. ing being sold or leased and the existence of any available records or reports § 745.113 Certification and acknowl- pertaining to lead-based paint and/or edgment of disclosure. lead-based paint hazards. The seller or (a) Seller requirements. Each contract lessor shall also disclose any additional to sell target housing shall include an information available concerning the attachment containing the following known lead-based paint and/or lead- based paint hazards, such as the basis elements, in the language of the con- for the determination that lead-based tract (e.g., English, Spanish): paint and/or lead-based paint hazards (1) A Lead Warning Statement con- exist, the location of the lead-based sisting of the following language: paint and/or lead-based paint hazards, Every purchaser of any interest in residen- and the condition of the painted sur- tial real property on which a residential faces. dwelling was built prior to 1978 is notified (4) The seller or lessor shall provide that such property may present exposure to the purchaser or lessee with any lead from lead-based paint that may place records or reports available to the sell- young children at risk of developing lead er or lessor pertaining to lead-based poisoning. Lead poisoning in young children paint and/or lead-based paint hazards may produce permanent neurological dam- in the target housing being sold or age, including learning disabilities, reduced leased. This requirement includes intelligence quotient, behavioral problems, and impaired memory. Lead poisoning also records or reports regarding common poses a particular risk to pregnant women. areas. This requirement also includes The seller of any interest in residential real records or reports regarding other resi- property is required to provide the buyer dential dwellings in multifamily target with any information on lead-based paint housing, provided that such informa- hazards from risk assessments or inspections tion is part of an evaluation or reduc- in the seller’s possession and notify the

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buyer of any known lead-based paint haz- language of the contract (e.g., English, ards. A risk assessment or inspection for pos- Spanish): sible lead-based paint hazards is rec- (1) A Lead Warning Statement with ommended prior to purchase. the following language: (2) A statement by the seller dis- closing the presence of known lead- Housing built before 1978 may contain lead- based paint and/or lead-based paint based paint. Lead from paint, paint chips, and dust can pose health hazards if not man- hazards in the target housing being aged properly. Lead exposure is especially sold or indicating no knowledge of the harmful to young children and pregnant presence of lead-based paint and/or women. Before renting pre-1978 housing, les- lead-based paint hazards. The seller sors must disclose the presence of lead-based shall also provide any additional infor- paint and/or lead-based paint hazards in the mation available concerning the dwelling. Lessees must also receive a feder- known lead-based paint and/or lead- ally approved pamphlet on lead poisoning based paint hazards, such as the basis prevention. for the determination that lead-based (2) A statement by the lessor dis- paint and/or lead-based paint hazards closing the presence of known lead- exist, the location of the lead-based based paint and/or lead-based paint paint and/or lead-based paint hazards, hazards in the target housing being and the condition of the painted sur- leased or indicating no knowledge of faces. the presence of lead-based paint and/or (3) A list of any records or reports lead-based paint hazards. The lessor available to the seller pertaining to shall also disclose any additional infor- lead-based paint and/or lead-based mation available concerning the paint hazards in the housing that have known lead-based paint and/or lead- been provided to the purchaser. If no based paint hazards, such as the basis such records or reports are available, for the determination that lead-based the seller shall so indicate. paint and/or lead-based paint hazards (4) A statement by the purchaser af- exist, the location of the lead-based firming receipt of the information set paint and/or lead-based paint hazards, out in paragraphs (a)(2) and (a)(3) of and the condition of the painted sur- this section and the lead hazard infor- faces. mation pamphlet required under 15 (3) A list of any records or reports U.S.C. 2696. available to the lessor pertaining to (5) A statement by the purchaser that lead-based paint and/or lead-based he/she has either: paint hazards in the housing that have (i) Received the opportunity to con- been provided to the lessee. If no such duct the risk assessment or inspection records or reports are available, the required by § 745.110(a); or lessor shall so indicate. (ii) Waived the opportunity. (6) When one or more agents are in- (4) A statement by the lessee affirm- volved in the transaction to sell target ing receipt of the information set out housing on behalf of the seller, a state- in paragraphs (b)(2) and (b)(3) of this ment that: section and the lead hazard informa- (i) The agent has informed the seller tion pamphlet required under 15 U.S.C. of the seller’s obligations under 42 2696. U.S.C. 4852d; and (5) When one or more agents are in- (ii) The agent is aware of his/her duty volved in the transaction to lease tar- to ensure compliance with the require- get housing on behalf of the lessor, a ments of this subpart. statement that: (7) The signatures of the sellers, (i) The agent has informed the lessor agents, and purchasers certifying to of the lessor as obligations under 42 the accuracy of their statements to the U.S.C. 4852d; and best of their knowledge, along with the (ii) The agent is aware of his/her duty dates of signature. to ensure compliance with the require- (b) Lessor requirements. Each contract ments of this subpart. to lease target housing shall include, (6) The signatures of the lessors, as an attachment or within the con- agents, and lessees, certifying to the tract, the following elements, in the accuracy of their statements, to the

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best of their knowledge, along with the § 745.118 Enforcement. dates of signature. (a) Any person who knowingly fails (c) Retention of Certification and Ac- to comply with any provision of this knowledgment Information. subpart shall be subject to civil mone- (1) The seller, and any agent, shall tary penalties in accordance with the retain a copy of the completed attach- provisions of 42 U.S.C. 3545 and 24 CFR ment required under paragraph (a) of part 30. this section for no less than 3 years (b) The Secretary is authorized to from the completion date of the sale. take such action as may be necessary The lessor, and any agent, shall retain to enjoin any violation of this subpart a copy of the completed attachment or in the appropriate Federal district lease contract containing the informa- court. tion required under paragraph (b) of (c) Any person who knowingly vio- this section for no less than 3 years lates the provisions of this subpart from the commencement of the leasing shall be jointly and severally liable to period. the purchaser or lessee in an amount (2) This recordkeeping requirement is equal to 3 times the amount of dam- not intended to place any limitations ages incurred by such individual. on civil suits under the Act, or to oth- (d) In any civil action brought for erwise affect a lessee’s or purchaser’s damages pursuant to 42 U.S.C. rights under the civil penalty provi- 4852d(b)(3), the appropriate court may sions of 42 U.S.C. 4852d(b)(3). award court costs to the party com- (d) The seller, lessor, or agent shall mencing such action, together with not be responsible for the failure of a reasonable attorney fees and any ex- purchaser’s or lessee’s legal representa- pert witness fees, if that party prevails. tive (where such representative re- (e) Failure or refusal to comply with ceives all compensation from the pur- § 745.107 (disclosure requirements for chaser or lessee) to transmit disclosure sellers and lessors), § 745.110 (oppor- materials to the purchaser or lessee, tunity to conduct an evaluation), provided that all required parties have § 745.113 (certification and acknowledg- completed and signed the necessary ment of disclosure), or § 745.115 (agent certification and acknowledgment lan- responsibilities) is a violation of 42 guage required under paragraphs (a) U.S.C. 4852d(b)(5) and of TSCA section and (b) of this section. 409 (15 U.S.C. 2689). (f) Violators may be subject to civil § 745.115 Agent responsibilities. and criminal sanctions pursuant to (a) Each agent shall ensure compli- TSCA section 16 (15 U.S.C. 2615) for ance with all requirements of this sub- each violation. For purposes of enforc- part. To ensure compliance, the agent ing this subpart, the penalty for each shall: violation applicable under 15 U.S.C. (1) Inform the seller or lessor of his/ 2615 shall not be more than $11,000 for her obligations under §§ 745.107, 745.110, all violations occuring after July 28, and 745.113. 1997; all violations occuring on or prior (2) Ensure that the seller or lessor to that date are subject to a penalty has performed all activities required not more than $10,000. under §§ 745.107, 745.110, and 745.113, or [61 FR 9085, Mar. 6, 1996, as amended at 62 FR personally ensure compliance with the 35041, June 27, 1997] requirements of §§ 745.107, 745.110, and 745.113. § 745.119 Impact on State and local re- (b) If the agent has complied with quirements. paragraph (a)(1) of this section, the Nothing in this subpart shall relieve agent shall not be liable for the failure a seller, lessor, or agent from any re- to disclose to a purchaser or lessee the sponsibility for compliance with State presence of lead-based paint and/or or local laws, ordinances, codes, or reg- lead-based paint hazards known by a ulations governing notice or disclosure seller or lessor but not disclosed to the of known lead-based paint or lead- agent. based paint hazards. Neither HUD nor

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EPA assumes any responsibility for en- paint activities, and lead-based paint suring compliance with such State or hazards. local requirements. (d) While this subpart establishes specific requirements for performing Subparts G–K [Reserved] lead-based paint activities should they be undertaken, nothing in this subpart requires that the owner or occupant Subpart L—Lead-Based Paint undertake any particular lead-based Activities paint activity. [61 FR 45813, Aug. 29, 1996, as amended at 73 SOURCE: 61 FR 45813, Aug. 29, 1996, unless FR 21766, Apr. 22, 2008] otherwise noted. § 745.223 Definitions. § 745.220 Scope and applicability. The definitions in subpart A apply to (a) This subpart contains procedures this subpart. In addition, the following and requirements for the accreditation definitions apply. of training programs for lead-based Abatement means any measure or set paint activities and renovations, proce- of measures designed to permanently dures and requirements for the certifi- eliminate lead-based paint hazards. cation of individuals and firms engaged Abatement includes, but is not limited in lead-based paint activities, and work to: practice standards for performing such (1) The removal of paint and dust, the activities. This subpart also requires permanent enclosure or encapsulation that, except as discussed below, all of lead-based paint, the replacement of lead-based paint activities, as defined painted surfaces or fixtures, or the rein this subpart, be performed by cer- moval or permanent covering of soil, tified individuals and firms. when lead-based paint hazards are (b) This subpart applies to all indi- present in such paint, dust or soil; and (2) All preparation, cleanup, disposal, viduals and firms who are engaged in and post-abatement clearance testing lead-based paint activities as defined in activities associated with such meas- § 745.223, except persons who perform ures. these activities within residential (3) Specifically, abatement includes, dwellings that they own, unless the but is not limited to: residential dwelling is occupied by a (i) Projects for which there is a writ- person or persons other than the owner ten contract or other documentation, or the owner’s immediate family while which provides that an individual or these activities are being performed, or firm will be conducting activities in or a child residing in the building has to a residential dwelling or child-occu- been identified as having an elevated pied facility that: blood lead level. This subpart applies (A) Shall result in the permanent only in those States or Indian Country elimination of lead-based paint haz- that do not have an authorized State or ards; or Tribal program pursuant to § 745.324 of (B) Are designed to permanently subpart Q. eliminate lead-based paint hazards and (c) Each department, agency, and in- are described in paragraphs (1) and (2) strumentality of the executive, legisla- of this definition. tive, and judicial branches of the Fed- (ii) Projects resulting in the perma- eral Government having jurisdiction nent elimination of lead-based paint over any property or facility, or en- hazards, conducted by firms or individ- gaged in any activity resulting, or uals certified in accordance with which may result, in a lead-based paint § 745.226, unless such projects are cov- hazard, and each officer, agent, or em- ered by paragraph (4) of this definition; ployee thereof shall be subject to, and (iii) Projects resulting in the perma- comply with, all Federal, State, inter- nent elimination of lead-based paint state, and local requirements, both hazards, conducted by firms or individ- substantive and procedural, including uals who, through their company name the requirements of this subpart re- or promotional literature, represent, garding lead-based paint, lead-based advertise, or hold themselves out to be

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in the business of performing lead- by this section, and certified by EPA based paint activities as identified and pursuant to § 745.226 to perform abate- defined by this section, unless such ments. projects are covered by paragraph (4) of Certified project designer means an in- this definition; or dividual who has been trained by an ac- (iv) Projects resulting in the perma- credited training program, as defined nent elimination of lead-based paint by this section, and certified by EPA hazards, that are conducted in response pursuant to § 745.226 to prepare abate- to State or local abatement orders. ment project designs, occupant protec- (4) Abatement does not include ren- tion plans, and abatement reports. ovation, remodeling, landscaping or Certified risk assessor means an indi- other activities, when such activities vidual who has been trained by an ac- are not designed to permanently elimi- credited training program, as defined nate lead-based paint hazards, but, in- by this section, and certified by EPA stead, are designed to repair, restore, pursuant to § 745.226 to conduct risk as- or remodel a given structure or dwell- sessments. A risk assessor also samples ing, even though these activities may for the presence of lead in dust and soil incidentally result in a reduction or for the purposes of abatement clear- elimination of lead-based paint haz- ance testing. ards. Furthermore, abatement does not Certified supervisor means an indi- include interim controls, operations vidual who has been trained by an ac- and maintenance activities, or other credited training program, as defined measures and activities designed to by this section, and certified by EPA temporarily, but not permanently, re- pursuant to § 745.226 to supervise and duce lead-based paint hazards. conduct abatements, and to prepare oc- Accredited training program means a cupant protection plans and abatement training program that has been accred- reports. ited by EPA pursuant to § 745.225 to Child-occupied facility means a build- provide training for individuals en- ing, or portion of a building, con- gaged in lead-based paint activities. structed prior to 1978, visited regularly Adequate quality control means a plan by the same child, 6 years of age or or design which ensures the authen- under, on at least two different days ticity, integrity, and accuracy of sam- within any week (Sunday through Sat- ples, including dust, soil, and paint urday period), provided that each day’s chip or paint film samples. Adequate visit lasts at least 3 hours and the com- quality control also includes provisions bined weekly visit lasts at least 6 for representative sampling. hours, and the combined annual visits Business day means Monday through last at least 60 hours. Child-occupied Friday with the exception of Federal facilities may include, but are not lim- holidays. ited to, day-care centers, preschools Certified firm means a company, part- and kindergarten classrooms. nership, corporation, sole proprietor- Clearance levels are values that indi- ship, association, or other business en- cate the maximum amount of lead per- tity that performs lead-based paint ac- mitted in dust on a surface following tivities to which EPA has issued a cer- completion of an abatement activity. tificate of approval pursuant to Common area means a portion of a § 745.226(f). building that is generally accessible to Certified inspector means an indi- all occupants. Such an area may in- vidual who has been trained by an ac- clude, but is not limited to, hallways, credited training program, as defined stairways, laundry and recreational by this section, and certified by EPA rooms, playgrounds, community cen- pursuant to § 745.226 to conduct inspec- ters, garages, and boundary fences. tions. A certified inspector also sam- Component or building component ples for the presence of lead in dust and means specific design or structural ele- soil for the purposes of abatement ments or fixtures of a building, residen- clearance testing. tial dwelling, or child-occupied facility Certified abatement worker means an that are distinguished from each other individual who has been trained by an by form, function, and location. These accredited training program, as defined include, but are not limited to, interior

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components such as: ceilings, crown Documented methodologies are meth- molding, walls, chair rails, doors, door ods or protocols used to sample for the trim, floors, fireplaces, radiators and presence of lead in paint, dust, and soil. other heating units, shelves, shelf sup- Elevated blood lead level (EBL) means ports, stair treads, stair risers, stair an excessive absorption of lead that is stringers, newel posts, railing caps, a confirmed concentration of lead in balustrades, windows and trim (includ- whole blood of 20 μg/dl (micrograms of ing sashes, window heads, jambs, sills lead per deciliter of whole blood) for a or stools and troughs), built in cabi- single venous test or of 15–19 μg/dl in nets, columns, beams, bathroom vani- two consecutive tests taken 3 to 4 ties, counter tops, and air conditioners; months apart. and exterior components such as: Encapsulant means a substance that painted roofing, chimneys, flashing, forms a barrier between lead-based gutters and downspouts, ceilings, sof- paint and the environment using a liquid-applied coating (with or without fits, fascias, rake boards, cornerboards, reinforcement materials) or an adhe- bulkheads, doors and door trim, fences, sively bonded covering material. floors, joists, lattice work, railings and Encapsulation means the application railing caps, siding, handrails, stair ris- of an encapsulant. ers and treads, stair stringers, col- Enclosure means the use of rigid, du- umns, balustrades, window sills or rable construction materials that are stools and troughs, casings, sashes and mechanically fastened to the substrate wells, and air conditioners. in order to act as a barrier between Containment means a process to pro- lead-based paint and the environment. tect workers and the environment by Guest instructor means an individual controlling exposures to the lead-con- designated by the training program taminated dust and debris created dur- manager or principal instructor to pro- ing an abatement. vide instruction specific to the lecture, Course agenda means an outline of hands-on activities, or work practice the key topics to be covered during a components of a course. training course, including the time al- Hands-on skills assessment means an lotted to teach each topic. evaluation which tests the trainees’ Course test means an evaluation of ability to satisfactorily perform the the overall effectiveness of the training work practices and procedures identi- which shall test the trainees’ knowl- fied in § 745.225(d), as well as any other edge and retention of the topics cov- skill taught in a training course. ered during the course. Hazardous waste means any waste as Course test blue print means written defined in 40 CFR 261.3. documentation identifying the propor- Inspection means a surface-by-surface tion of course test questions devoted to investigation to determine the pres- each major topic in the course cur- ence of lead-based paint and the provision of a report explaining the results riculum. of the investigation. Deteriorated paint means paint that is Interim certification means the status cracking, flaking, chipping, peeling, or of an individual who has successfully otherwise separating from the sub- completed the appropriate training strate of a building component. course in a discipline from an accred- Discipline means one of the specific ited training program, as defined by types or categories of lead-based paint this section, but has not yet received activities identified in this subpart for formal certification in that discipline which individuals may receive training from EPA pursuant to § 745.226. Interim from accredited programs and become certifications expire 6 months after the certified by EPA. For example, completion of the training course, and ‘‘abatement worker’’ is a discipline. is equivalent to a certificate for the 6- Distinct painting history means the ap- month period. plication history, as indicated by its Interim controls means a set of meas- visual appearance or a record of appli- ures designed to temporarily reduce cation, over time, of paint or other sur- human exposure or likely exposure to face coatings to a component or room. lead-based paint hazards, including

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specialized cleaning, repairs, mainte- ment, that no part of its net earnings nance, painting, temporary contain- inure to the benefit of any private ment, ongoing monitoring of lead- shareholder or individual. based paint hazards or potential haz- Paint in poor condition means more ards, and the establishment and oper- than 10 square feet of deteriorated ation of management and resident edu- paint on exterior components with cation programs. large surface areas; or more than 2 Lead-based paint means paint or other square feet of deteriorated paint on in- surface coatings that contain lead terior components with large surface equal to or in excess of 1.0 milligrams areas (e.g., walls, ceilings, floors, per square centimeter or more than 0.5 doors); or more than 10 percent of the percent by weight. total surface area of the component is Lead-based paint activities means, in deteriorated on interior or exterior the case of target housing and child-oc- components with small surface areas cupied facilities, inspection, risk as- (window sills, baseboards, soffits, sessment, and abatement, as defined in this subpart. trim). Lead-based paint activities courses Permanently covered soil means soil means initial and refresher training which has been separated from human courses (worker, supervisor, inspector, contact by the placement of a barrier risk assessor, project designer) pro- consisting of solid, relatively imper- vided by accredited training programs. meable materials, such as pavement or Lead-based paint hazard means any concrete. Grass, mulch, and other land- condition that causes exposure to lead scaping materials are not considered from lead-contaminated dust, lead-con- permanent covering. taminated soil, or lead-contaminated Person means any natural or judicial paint that is deteriorated or present in person including any individual, cor- accessible surfaces, friction surfaces, poration, partnership, or association; or impact surfaces that would result in any Indian Tribe, State, or political adverse human health effects as identi- subdivision thereof; any interstate fied by the Administrator pursuant to body; and any department, agency, or TSCA section 403. instrumentality of the Federal govern- Lead-hazard screen is a limited risk ment. assessment activity that involves lim- Principal instructor means the indi- ited paint and dust sampling as de- vidual who has the primary responsi- scribed in § 745.227(c). bility for organizing and teaching a Living area means any area of a resi- particular course. dential dwelling used by one or more Recognized laboratory means an envi- children age 6 and under, including, but ronmental laboratory recognized by not limited to, living rooms, kitchen EPA pursuant to TSCA section 405(b) areas, dens, play rooms, and children’s as being capable of performing an anal- bedrooms. ysis for lead compounds in paint, soil, Local government means a county, and dust. city, town, borough, parish, district, association, or other public body (in- Reduction means measures designed cluding an agency comprised of two or to reduce or eliminate human exposure more of the foregoing entities) created to lead-based paint hazards through under State law. methods including interim controls Multi-family dwelling means a struc- and abatement. ture that contains more than one sepa- Residential dwelling means (1) a de- rate residential dwelling unit, which is tached single family dwelling unit, in- used or occupied, or intended to be cluding attached structures such as used or occupied, in whole or in part, porches and stoops; or (2) a single fam- as the home or residence of one or ily dwelling unit in a structure that more persons. contains more than one separate resi- Nonprofit means an entity which has dential dwelling unit, which is used or demonstrated to any branch of the occupied, or intended to be used or oc- Federal Government or to a State, mu- cupied, in whole or in part, as the home nicipal, tribal or territorial govern- or residence of one or more persons.

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Risk assessment means (1) an on-site mine whether or not the abatement has investigation to determine the exist- been successfully completed. ence, nature, severity, and location of Visual inspection for risk assessment lead-based paint hazards, and (2) the means the visual examination of a resi- provision of a report by the individual dential dwelling or a child-occupied fa- or the firm conducting the risk assess- cility to determine the existence of de- ment, explaining the results of the in- teriorated lead-based paint or other po- vestigation and options for reducing tential sources of lead-based paint haz- lead-based paint hazards. ards. Start date means the first day of any [61 FR 45813, Aug. 29, 1996, as amended at 64 lead-based paint activities training FR 31097, June 9, 1999; 66 FR 1239, Jan. 5, 2001; course or lead-based paint abatement 69 FR 18495, Apr. 8, 2004] activity. Start date provided to EPA means the § 745.225 Accreditation of training pro- start date included in the original noti- grams: target housing and child-occupied facilities. fication or the most recent start date provided to EPA in an updated notifi- (a) Scope. (1) A training program may cation. seek accreditation to offer courses in State means any State of the United any of the following disciplines: Inspec- States, the District of Columbia, the tor, risk assessor, supervisor, project Commonwealth of Puerto Rico, the designer, abatement worker, renovator, Virgin Islands, Guam, the Canal Zone, and dust sampling technician. A train- American Samoa, the Northern Mar- ing program may also seek accredita- iana Islands, or any other territory or tion to offer refresher courses for each possession of the United States. of the above listed disciplines. (2) Training programs may first Target housing means any housing apply to EPA for accreditation of their constructed prior to 1978, except hous- lead-based paint activities courses or ing for the elderly or persons with dis- refresher courses pursuant to this sec- abilities (unless any one or more chil- tion on or after August 31, 1998. Train- dren age 6 years or under resides or is ing programs may first apply to EPA expected to reside in such housing for for accreditation of their renovator or the elderly or persons with disabilities) dust sampling technician courses or re- or any 0-bedroom dwelling. fresher courses pursuant to this section Training curriculum means an estab- on or after April 22, 2009. lished set of course topics for instruc- (3) A training program must not pro- tion in an accredited training program vide, offer, or claim to provide EPA-ac- for a particular discipline designed to credited lead-based paint activities provide specialized knowledge and courses without applying for and re- skills. ceiving accreditation from EPA as re- Training hour means at least 50 min- quired under paragraph (b) of this sec- utes of actual learning, including, but tion on or after March 1, 1999. A train- not limited to, time devoted to lecture, ing program must not provide, offer, or learning activities, small group activi- claim to provide EPA-accredited ren- ties, demonstrations, evaluations, and/ ovator or dust sampling technician or hands-on experience. courses without applying for and re- Training manager means the indi- ceiving accreditation from EPA as re- vidual responsible for administering a quired under paragraph (b) of this sec- training program and monitoring the tion on or after June 23, 2008. performance of principal instructors (b) Application process. The following and guest instructors. are procedures a training program Training provider means any organiza- must follow to receive EPA accreditation or entity accredited under § 745.225 tion to offer lead-based paint activities to offer lead-based paint activities courses, renovator courses, or dust courses. sampling technician courses: Visual inspection for clearance testing (1) A training program seeking ac- means the visual examination of a resi- creditation shall submit a written ap- dential dwelling or a child-occupied fa- plication to EPA containing the fol- cility following an abatement to deter- lowing information:

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(i) The training program’s name, ad- plete application from the training dress, and telephone number. program. In the case of approval, a cer- (ii) A list of courses for which it is tificate of accreditation shall be sent applying for accreditation. For the pur- to the applicant. In the case of disposes of this section, courses taught in approval, a letter describing the rea- different languages are considered dif- sons for disapproval shall be sent to ferent courses, and each must inde- the applicant. Prior to disapproval, pendently meet the accreditation re- EPA may, at its discretion, work with quirements. the applicant to address inadequacies (iii) A statement signed by the train- in the application for accreditation. ing program manager certifying that EPA may also request additional mate- the training program meets the re- rials retained by the training program quirements established in paragraph under paragraph (i) of this section. If a (c) of this section. If a training pro- training program’s application is dis- gram uses EPA-recommended model approved, the program may reapply for training materials, or training mate- accreditation at any time. rials approved by a State or Indian (3) A training program may apply for Tribe that has been authorized by EPA accreditation to offer courses or re- under subpart Q of this part, the train- fresher courses in as many disciplines ing program manager shall include a as it chooses. A training program may statement certifying that, as well. seek accreditation for additional (iv) If a training program does not courses at any time as long as the pro- use EPA-recommended model training gram can demonstrate that it meets materials or training materials ap- the requirements of this section. proved by an authorized State or In- (4) A training program applying for dian Tribe, its application for accredi- accreditation must submit the appro- tation shall also include: priate fees in accordance with § 745.238. (A) A copy of the student and in- (c) Requirements for the accreditation structor manuals, or other materials to of training programs. For a training probe used for each course. gram to obtain accreditation from EPA (B) A copy of the course agenda for to offer lead-based paint activities each course. courses, renovator courses, or dust (C) When applying for accreditation sampling technician courses, the proof a course in a language other than gram must meet the following require- English, a signed statement from a ments: qualified, independent translator that they had compared the course to the (1) The training program shall em- English language version and found the ploy a training manager who has: translation to be accurate. (i) At least 2 years of experience, edu- (v) All training programs shall in- cation, or training in teaching workers clude in their application for accredita- or adults; or tion the following: (ii) A bachelor’s or graduate degree (A) A description of the facilities and in building construction technology, equipment to be used for lecture and engineering, industrial hygiene, safety, hands-on training. public health, education, business ad- (B) A copy of the course test blue- ministration or program management print for each course. or a related field; or (C) A description of the activities and (iii) Two years of experience in man- procedures that will be used for con- aging a training program specializing ducting the assessment of hands-on in environmental hazards; and skills for each course. (iv) Demonstrated experience, edu- (D) A copy of the quality control plan cation, or training in the construction as described in paragraph (c)(9) of this industry including: lead or asbestos section. abatement, painting, carpentry, ren- (2) If a training program meets the ovation, remodeling, occupational safe- requirements in paragraph (c) of this ty and health, or industrial hygiene. section, then EPA shall approve the ap- (2) The training manager shall des- plication for accreditation no more ignate a qualified principal instructor than 180 days after receiving a com- for each course who has:

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(i) Demonstrated experience, edu- that reflects current work practices cation, or training in teaching workers and maintaining or updating the equip- or adults; and ment and facilities as needed. (ii) Successfully completed at least 16 (6) To become accredited in the fol- hours of any EPA-accredited or EPA- lowing disciplines, the training pro- authorized State or Tribal-accredited gram shall provide training courses lead-specific training for instructors of that meet the following training hour lead-based paint activities courses or 8 requirements: hours of any EPA-accredited or EPA- (i) The inspector course shall last a authorized State or Tribal-accredited minimum of 24 training hours, with a lead-specific training for instructors of minimum of 8 hours devoted to hands- renovator or dust sampling technician on training activities. The minimum courses; and curriculum requirements for the in- (iii) Demonstrated experience, edu- spector course are contained in para- cation, or training in lead or asbestos graph (d)(1) of this section. abatement, painting, carpentry, ren- (ii) The risk assessor course shall last ovation, remodeling, occupational safe- a minimum of 16 training hours, with a ty and health, or industrial hygiene. minimum of 4 hours devoted to hands- (3) The principal instructor shall be on training activities. The minimum responsible for the organization of the curriculum requirements for the risk course and oversight of the teaching of assessor course are contained in para- all course material. The training man- graph (d)(2) of this section. ager may designate guest instructors (iii) The supervisor course shall last as needed to provide instruction spe- a minimum of 32 training hours, with a cific to the lecture, hands-on activi- minimum of 8 hours devoted to hands- ties, or work practice components of a on activities. The minimum cur- course. riculum requirements for the super- (4) The following documents shall be visor course are contained in paragraph recognized by EPA as evidence that (d)(3) of this section. training managers and principal in- (iv) The project designer course shall structors have the education, work ex- last a minimum of 8 training hours. perience, training requirements or The minimum curriculum require- demonstrated experience, specifically ments for the project designer course listed in paragraphs (c)(1) and (c)(2) of are contained in paragraph (d)(4) of this section. This documentation need this section. not be submitted with the accredita- (v) The abatement worker course tion application, but, if not submitted, shall last a minimum of 16 training shall be retained by the training pro- hours, with a minimum of 8 hours de- gram as required by the recordkeeping voted to hands-on training activities. requirements contained in paragraph The minimum curriculum require- (i) of this section. Those documents in- ments for the abatement worker course clude the following: are contained in paragraph (d)(5) of (i) Official academic transcripts or this section. diploma as evidence of meeting the (vi) The renovator course must last a education requirements. minimum of 8 training hours, with a (ii) Resumes, letters of reference, or minimum of 2 hours devoted to hands- documentation of work experience, as on training activities. The minimum evidence of meeting the work experi- curriculum requirements for the ren- ence requirements. ovator course are contained in para- (iii) Certificates from train-the-train- graph (d)(6) of this section. Hands-on er courses and lead-specific training training activities must cover renova- courses, as evidence of meeting the tion methods that minimize the cre- training requirements. ation of dust and lead-based paint haz- (5) The training program shall ensure ards, interior and exterior containment the availability of, and provide ade- and cleanup methods, and post-renova- quate facilities for, the delivery of the tion cleaning verification. lecture, course test, hands-on training, (vii) The dust sampling technician and assessment activities. This in- course must last a minimum of 8 train- cludes providing training equipment ing hours, with a minimum of 2 hours

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devoted to hands-on training activities. (vii) For renovator and dust sampling The minimum curriculum require- technician course completion certifi- ments for the dust sampling technician cates, a photograph of the individual. course are contained in paragraph (9) The training manager shall de- (d)(7) of this section. Hands-on training velop and implement a quality control activities must cover dust sampling plan. The plan shall be used to main- methodologies. tain and improve the quality of the (7) For each course offered, the train- training program over time. This plan ing program shall conduct either a shall contain at least the following ele- course test at the completion of the ments: course, and if applicable, a hands-on (i) Procedures for periodic revision of skills assessment, or in the alternative, training materials and the course test a proficiency test for that discipline. to reflect innovations in the field. Each individual must successfully com- (ii) Procedures for the training man- plete the hands-on skills assessment ager’s annual review of principal in- and receive a passing score on the structor competency. course test to pass any course, or suc- (10) Courses offered by the training cessfully complete a proficiency test. program must teach the work practice (i) The training manager is respon- standards contained in § 745.85 or sible for maintaining the validity and § 745.227, as applicable, in such a man- integrity of the hands-on skills assess- ner that trainees are provided with the ment or profiency test to ensure that it knowledge needed to perform the ren- accurately evaluates the trainees’ per- ovations or lead-based paint activities formance of the work practices and they will be responsible for conducting. procedures associated with the course (11) The training manager shall be re- topics contained in paragraph (d) of sponsible for ensuring that the training this section. program complies at all times with all (ii) The training manager is respon- of the requirements in this section. sible for maintaining the validity and (12) The training manager shall allow integrity of the course test to ensure EPA to audit the training program to that it accurately evaluates the train- verify the contents of the application ees’ knowledge and retention of the for accreditation as described in para- course topics. graph (b) of this section. (iii) The course test shall be devel- (13) The training manager must pro- oped in accordance with the test blue- vide notification of renovator, dust print submitted with the training ac- sampling technician, or renovator, dust creditation application. sampling technician, or lead-based paint activities offered. (8) The training program shall issue (i) The training manager must pro- unique course completion certificates vide EPA with notification of all ren- to each individual who passes the ovator, dust sampling technician, or training course. The course completion lead-based paint activities courses of- certificate shall include: fered. The original notification must (i) The name, a unique identification be received by EPA at least 7 business number, and address of the individual. days prior to the start date of any ren- (ii) The name of the particular course ovator, dust sampling technician, or that the individual completed. lead-based paint activities course. (iii) Dates of course completion/test (ii) The training manager must pro- passage. vide EPA updated notification when (iv) For initial inspector, risk asses- renovator, dust sampling technician, or sor, project designer, supervisor, or lead-based paint activities courses will abatement worker course completion begin on a date other than the start certificates, the expiration date of in- date specified in the original notifica- terim certification, which is 6 months tion, as follows: from the date of course completion. (A) For renovator, dust sampling (v) The name, address, and telephone technician, or lead-based paint activi- number of the training program. ties courses beginning prior to the (vi) The language in which the course start date provided to EPA, an updated was taught. notification must be received by EPA

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at least 7 business days before the new notification by the required date). In- start date. structions and sample forms can be ob- (B) For renovator, dust sampling tained from the NLIC at 1–800–424– technician, or lead-based paint activi- LEAD(5323), or on the Internet at http:// ties courses beginning after the start www.epa.gov/lead. date provided to EPA, an updated noti- (vii) Lead-based paint activities fication must be received by EPA at courses must not begin on a date, or at least 2 business days before the start a location other than that specified in date provided to EPA. the original notification unless an up- (iii) The training manager must updated notification identifying a new date EPA of any change in location of start date or location is submitted, in renovator, dust sampling technician, or which case the course must begin on lead-based paint activities courses at the new start date and/or location spec- least 7 business days prior to the start ified in the updated notification. date provided to EPA. (viii) No training program shall pro- (iv) The training manager must up- vide renovator, dust sampling techni- date EPA regarding any course can- cian, or lead-based paint activities cellations, or any other change to the courses without first notifying EPA of original notification. Updated notifica- such activities in accordance with the tions must be received by EPA at least requirements of this paragraph. 2 business days prior to the start date (14) The training manager must pro- provided to EPA. vide notification following completion (v) Each notification, including up- of renovator, dust sampling technician, dates, must include the following: or lead-based paint activities courses. (A) Notification type (original, up- (i) The training manager must pro- date, cancellation). vide EPA notification after the com- (B) Training program name, EPA ac- pletion of any renovator, dust sampling creditation number, address, and tele- technician, or lead-based paint activi- phone number. ties course. This notice must be re- (C) Course discipline, type (initial/ ceived by EPA no later than 10 busi- refresher), and the language in which ness days following course completion. instruction will be given. (ii) The notification must include the (D) Date(s) and time(s) of training. following: (E) Training location(s) telephone (A) Training program name, EPA ac- number, and address. creditation number, address, and tele- (F) Principal instructor’s name. phone number. (G) Training manager’s name and sig- (B) Course discipline and type (ini- nature. tial/refresher). (vi) Notification must be accom- (C) Date(s) of training. plished using any of the following (D) The following information for methods: Written notification, or elec- each student who took the course: tronically using the Agency’s Central (1) Name. Data Exchange (CDX). Written notifi- (2) Address. cation of renovator, dust sampling (3) Date of birth. technician, or lead-based paint activi- (4) Course completion certificate ties course schedules can be accom- number. plished by using either the sample form (5) Course test score. titled ‘‘Lead-Based Paint Activities (6) For renovator or dust sampling Training Course Schedule’’ or a similar technician courses only, a digital pho- form containing the information re- tograph of the student. quired in paragraph (c)(13)(v) of this (E) Training manager’s name and sig- section. All written notifications must nature. be delivered by U.S. Postal Service, (iii) Notification must be accom- fax, commercial delivery service, or plished using any of the following hand delivery (persons submitting noti- methods: Written notification, or elec- fication by U.S. Postal Service are re- tronically using the Agency’s Central minded that they should allow 3 addi- Data Exchange (CDX). Written notifi- tional business days for delivery in cation following training courses can order to ensure that EPA receives the be accomplished by using either the

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sample form, entitled Post-Training No- (vi) Sampling for other sources of tification or a similar form containing lead exposure.* the information required in paragraph (vii) Interpretation of lead-based (c)(14)(ii) of this section. All written paint and other lead sampling results, notifications must be delivered by U.S. including all applicable State or Fed- Postal Service, fax, commercial deliv- eral guidance or regulations pertaining ery service, or hand delivery (persons to lead-based paint hazards.* submitting notification by U.S. Postal (viii) Development of hazard control Service are reminded that they should options, the role of interim controls, allow 3 additional business days for de- and operations and maintenance activi- livery in order to ensure that EPA re- ties to reduce lead-based paint hazards. ceives the notification by the required (ix) Preparation of a final risk assess- date). Instructions and sample forms ment report. can be obtained from the NLIC at 1– (3) Supervisor. (i) Role and respon- 800–424–LEAD (5323), or on the Internet sibilities of a supervisor. at http://www.epa.gov/lead. (ii) Background information on lead (d) Minimum training curriculum re- and its adverse health effects. quirements. To become accredited to (iii) Background information on Fed- offer lead-based paint courses instruc- eral, State, and local regulations and tion in the specific disciplines listed guidance that pertain to lead-based below, training programs must ensure paint abatement. that their courses of study include, at (iv) Liability and insurance issues re- a minimum, the following course top- lating to lead-based paint abatement. ics. Requirements ending in an asterisk (v) Risk assessment and inspection (*) indicate areas that require hands-on report interpretation.* activities as an integral component of (vi) Development and implementa- the course. tion of an occupant protection plan and (1) Inspector. (i) Role and responsibil- abatement report. ities of an inspector. (vii) Lead-based paint hazard rec- (ii) Background information on lead ognition and control.* and its adverse health effects. (viii) Lead-based paint abatement (iii) Background information on Fed- and lead-based paint hazard reduction eral, State, and local regulations and methods, including restricted prac- guidance that pertains to lead-based tices.* paint and lead-based paint activities. (ix) Interior dust abatement/cleanup (iv) Lead-based paint inspection or lead-based paint hazard control and methods, including selection of rooms reduction methods.* and components for sampling or test- (x) Soil and exterior dust abatement ing.* or lead-based paint hazard control and (v) Paint, dust, and soil sampling reduction methods.* methodologies.* (xi) Clearance standards and testing. (vi) Clearance standards and testing, (xii) Cleanup and waste disposal. including random sampling.* (xiii) Recordkeeping. (vii) Preparation of the final inspec- (4) Project designer. (i) Role and re- tion report.* sponsibilities of a project designer. (viii) Recordkeeping. (ii) Development and implementation (2) Risk assessor. (i) Role and respon- of an occupant protection plan for sibilities of a risk assessor. large scale abatement projects. (ii) Collection of background infor- (iii) Lead-based paint abatement and mation to perform a risk assessment. lead-based paint hazard reduction (iii) Sources of environmental lead methods, including restricted practices contamination such as paint, surface for large-scale abatement projects. dust and soil, water, air, packaging, (iv) Interior dust abatement/cleanup and food. or lead hazard control and reduction (iv) Visual inspection for the pur- methods for large-scale abatement poses of identifying potential sources projects. of lead-based paint hazards.* (v) Clearance standards and testing (v) Lead hazard screen protocol. for large scale abatement projects.

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(vi) Integration of lead-based paint (v) Clearance standards and testing. abatement methods with moderniza- (vi) Report preparation. tion and rehabilitation projects for (e) Requirements for the accreditation large scale abatement projects. of refresher training programs. A train- (5) Abatement worker. (i) Role and re- ing program may seek accreditation to sponsibilities of an abatement worker. offer refresher training courses in any (ii) Background information on lead of the following disciplines: Inspector, and its adverse health effects. risk assessor, supervisor, project de- (iii) Background information on Fed- signer, abatement worker, renovator, eral, State and local regulations and and dust sampling technician. To ob- guidance that pertain to lead-based tain EPA accreditation to offer re- paint abatement. fresher training, a training program (iv) Lead-based paint hazard recogni- must meet the following minimum re- tion and control.* quirements: (v) Lead-based paint abatement and (1) Each refresher course shall review lead-based paint hazard reduction the curriculum topics of the full-length methods, including restricted prac- courses listed under paragraph (d) of tices.* this section, as appropriate. In addi- (vi) Interior dust abatement methods/ tion, to become accredited to offer re- cleanup or lead-based paint hazard refresher training courses, training production.* grams shall ensure that their courses (vii) Soil and exterior dust abate- of study include, at a minimum, the ment methods or lead-based paint haz- following: ard reduction.* (i) An overview of current safety (6) Renovator. (i) Role and responsibility of a renovator. practices relating to lead-based paint (ii) Background information on lead in general, as well as specific informa- and its adverse health effects. tion pertaining to the appropriate dis- (iii) Background information on cipline. EPA, HUD, OSHA, and other Federal, (ii) Current laws and regulations re- State, and local regulations and guid- lating to lead-based paint in general, as ance that pertains to lead-based paint well as specific information pertaining and renovation activities. to the appropriate discipline. (iv) Procedures for using acceptable (iii) Current technologies relating to test kits to determine whether paint is lead-based paint in general, as well as lead-based paint. specific information pertaining to the (v) Renovation methods to minimize appropriate discipline. the creation of dust and lead-based (2) Refresher courses for inspector, paint hazards. risk assessor, supervisor, and abate- (vi) Interior and exterior containment worker must last a minimum of 8 ment and cleanup methods. training hours. Refresher courses for (vii) Methods to ensure that the ren- project designer, renovator, and dust ovation has been properly completed, sampling technician must last a min- including cleaning verification, and imum of 4 training hours. clearance testing. (3) For each course offered, the train- (viii) Waste handling and disposal. ing program shall conduct a hands-on (ix) Providing on-the-job training to assessment (if applicable), and at the other workers. completion of the course, a course test. (x) Record preparation. (4) A training program may apply for (7) Dust sampling technician. (i) Role accreditation of a refresher course con- and responsibility of a dust sampling currently with its application for ac- technician. creditation of the corresponding train- (ii) Background information on lead ing course as described in paragraph (b) and its adverse health effects. of this section. If so, EPA shall use the (iii) Background information on Fed- approval procedure described in para- eral, State, and local regulations and graph (b) of this section. In addition, guidance that pertains to lead-based the minimum requirements contained paint and renovation activities. in paragraphs (c) (except for the re- (iv) Dust sampling methodologies. quirements in paragraph (c)(6)), and

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(e)(1), (e)(2) and (e)(3) of this section paragraph, then EPA shall approve the shall also apply. application for accreditation no more (5) A training program seeking ac- than 180 days after receiving a com- creditation to offer refresher training plete application from the refresher courses only shall submit a written ap- training program. In the case of application to EPA containing the fol- proval, a certificate of accreditation lowing information: shall be sent to the applicant. In the (i) The refresher training program’s case of disapproval, a letter describing name, address, and telephone number. the reasons for disapproval shall be (ii) A list of courses for which it is sent to the applicant. Prior to dis- applying for accreditation. approval, EPA may, at its discretion, (iii) A statement signed by the train- work with the applicant to address in- ing program manager certifying that adequacies in the application for ac- the refresher training program meets creditation. EPA may also request ad- the minimum requirements established ditional materials retained by the rein paragraph (c) of this section, except fresher training program under para- for the requirements in paragraph (c)(6) graph (i) of this section. If a refresher of this section. If a training program training program’s application is dis- uses EPA-developed model training approved, the program may reapply for materials, or training materials ap- accreditation at any time. proved by a State or Indian Tribe that (f) Re-accreditation of training pro- has been authorized by EPA under grams. (1) Unless re-accredited, a train- § 745.324 to develop its refresher training program’s accreditation (including ing course materials, the training man- refresher training accreditation) shall ager shall include a statement certi- expire 4 years after the date of fying that, as well. issuance. If a training program meets (iv) If the refresher training course the requirements of this section, the materials are not based on EPA-devel- training program shall be re-accred- oped model training materials or train- ited. ing materials approved by an author- (2) A training program seeking re-ac- ized State or Indian Tribe, the training creditation shall submit an application program’s application for accreditation to EPA no later than 180 days before its shall include: accreditation expires. If a training pro- (A) A copy of the student and in- gram does not submit its application structor manuals to be used for each for re-accreditation by that date, EPA course. cannot guarantee that the program (B) A copy of the course agenda for will be re-accredited before the end of each course. the accreditation period. (v) All refresher training programs (3) The training program’s applica- shall include in their application for tion for re-accreditation shall contain: accreditation the following: (A) A description of the facilities and (i) The training program’s name, ad- equipment to be used for lecture and dress, and telephone number. hands-on training. (ii) A list of courses for which it is (B) A copy of the course test blue- applying for re-accreditation. print for each course. (iii) A description of any changes to (C) A description of the activities and the training facility, equipment or procedures that will be used for con- course materials since its last applica- ducting the assessment of hands-on tion was approved that adversely af- skills for each course (if applicable). fects the students ability to learn. (D) A copy of the quality control plan (iv) A statement signed by the pro- as described in paragraph (c)(9) of this gram manager stating: section. (A) That the training program com- (vi) The requirements in paragraphs plies at all times with all requirements (c)(1) through (c)(5), and (c)(7) through in paragraphs (c) and (e) of this sec- (c)(14) of this section apply to refresher tion, as applicable; and training providers. (B) The recordkeeping and reporting (vii) If a refresher training program requirements of paragraph (i) of this meets the requirements listed in this section shall be followed.

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(v) A payment of appropriate fees in (ii) The anticipated commencement accordance with § 745.238. date and duration of the suspension, (4) Upon request, the training pro- revocation, or modification. gram shall allow EPA to audit the (iii) Actions, if any, which the af- training program to verify the con- fected entity may take to avoid sus- tents of the application for re-accredi- pension, revocation, or modification, or tation as described in paragraph (f)(3) to receive accreditation in the future. of this section. (iv) The opportunity and method for (g) Suspension, revocation, and modi- requesting a hearing prior to final EPA fication of accredited training programs. action to suspend, revoke or modify ac- (1) EPA may, after notice and an op- creditation. portunity for hearing, suspend, revoke, (v) Any additional information, as or modify training program accredita- appropriate, which EPA may provide. tion (including refresher training ac- (2) If a hearing is requested by the accreditation) if a training program, credited training program, EPA shall: training manager, or other person with (i) Provide the affected entity an op- supervisory authority over the training portunity to offer written statements program has: in response to EPA’s assertions of the (i) Misrepresented the contents of a legal and factual basis for its proposed training course to EPA and/or the stu- action, and any other explanations, dent population. comments, and arguments it deems rel- (ii) Failed to submit required infor- evant to the proposed action. mation or notifications in a timely (ii) Provide the affected entity such manner. other procedural opportunities as EPA may deem appropriate to ensure a fair (iii) Failed to maintain required and impartial hearing. records. (iii) Appoint an official of EPA as (iv) Falsified accreditation records, Presiding Officer to conduct the hear- instructor qualifications, or other ac- ing. No person shall serve as Presiding creditation-related information or doc- Officer if he or she has had any prior umentation. connection with the specific matter. (v) Failed to comply with the train- (3) The Presiding Officer appointed ing standards and requirements in this pursuant to paragraph (h)(2) of this section. section shall: (vi) Failed to comply with Federal, (i) Conduct a fair, orderly, and impar- State, or local lead-based paint stat- tial hearing within 90 days of the re- utes or regulations. quest for a hearing. (vii) Made false or misleading state- (ii) Consider all relevant evidence, ments to EPA in its application for ac- explanation, comment, and argument creditation or re-accreditation which submitted. EPA relied upon in approving the ap- (iii) Notify the affected entity in plication. writing within 90 days of completion of (2) In addition to an administrative the hearing of his or her decision and or judicial finding of violation, execu- order. Such an order is a final agency tion of a consent agreement in settle- action which may be subject to judicial ment of an enforcement action con- review. stitutes, for purposes of this section, (4) If EPA determines that the public evidence of a failure to comply with health, interest, or welfare warrants relevant statutes or regulations. immediate action to suspend the ac- (h) Procedures for suspension, revoca- creditation of any training program tion or modification of training program prior to the opportunity for a hearing, accreditation. (1) Prior to taking action it shall: to suspend, revoke, or modify the ac- (i) Notify the affected entity of its in- creditation of a training program, EPA tent to immediately suspend training shall notify the affected entity in writ- program accreditation for the reasons ing of the following: listed in paragraph (g)(1) of this sec- (i) The legal and factual basis for the tion. If a suspension, revocation, or suspension, revocation, or modifica- modification notice has not previously tion. been issued pursuant to paragraph

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(g)(1) of this section, it shall be issued (iv) Information regarding how the at the same time the emergency sus- hands-on assessment is conducted in- pension notice is issued. cluding, but not limited to: (ii) Notify the affected entity in writ- (A) Who conducts the assessment. ing of the grounds for the immediate (B) How the skills are graded. suspension and why it is necessary to (C) What facilities are used. suspend the entity’s accreditation be- (D) The pass/fail rate. fore an opportunity for a suspension, (v) The quality control plan as de- revocation or modification hearing. scribed in paragraph (c)(9) of this sec- (iii) Notify the affected entity of the tion. anticipated commencement date and (vi) Results of the students’ hands-on duration of the immediate suspension. skills assessments and course tests, (iv) Notify the affected entity of its and a record of each student’s course right to request a hearing on the im- completion certificate. mediate suspension within 15 days of (vii) Any other material not listed the suspension taking place and the above in paragraphs (i)(1)(i) through procedures for the conduct of such a (i)(1)(vi) of this section that was sub- hearing. mitted to EPA as part of the program’s (5) Any notice, decision, or order application for accreditation. issued by EPA under this section, any (2) The training program shall retain transcripts or other verbatim record of these records at the address specified oral testimony, and any documents on the training program accreditation filed by an accredited training program application (or as modified in accord- in a hearing under this section shall be ance with paragraph (i)(3) of this sec- available to the public, except as oth- tion for a minimum of 3 years and 6 erwise provided by section 14 of TSCA months. or by part 2 of this title. Any such (3) The training program shall notify hearing at which oral testimony is pre- EPA in writing within 30 days of sented shall be open to the public, ex- changing the address specified on its cept that the Presiding Officer may ex- training program accreditation appli- clude the public to the extent nec- cation or transferring the records from essary to allow presentation of infor- that address. mation which may be entitled to confidential treatment under section 14 of [61 FR 45813, Aug. 29, 1996, as amended at 64 FR 31098, June 9, 1999; 69 FR 18495, Apr. 8, TSCA or part 2 of this title. 2004; 73 FR 21766, Apr. 22, 2008; 74 FR 34262, (6) The public shall be notified of the July 15, 2009; 75 FR 24819, May 6, 2010] suspension, revocation, modification or reinstatement of a training program’s § 745.226 Certification of individuals accreditation through appropriate and firms engaged in lead-based mechanisms. paint activities: target housing and (7) EPA shall maintain a list of par- child-occupied facilities. ties whose accreditation has been sus- (a) Certification of individuals. (1) Indi- pended, revoked, modified or rein- viduals seeking certification by EPA to stated. engage in lead-based paint activities (i) Training program recordkeeping re- must either: quirements. (1) Accredited training pro- (i) Submit to EPA an application grams shall maintain, and make avail- demonstrating that they meet the re- able to EPA, upon request, the fol- quirements established in paragraphs lowing records: (b) or (c) of this section for the par- (i) All documents specified in para- ticular discipline for which certifi- graph (c)(4) of this section that dem- cation is sought; or onstrate the qualifications listed in (ii) Submit to EPA an application paragraphs (c)(1) and (c)(2) of this sec- with a copy of a valid lead-based paint tion of the training manager and prin- activities certification (or equivalent) cipal instructors. from a State or Tribal program that (ii) Current curriculum/course mate- has been authorized by EPA pursuant rials and documents reflecting any to subpart Q of this part. changes made to these materials. (2) Individuals may first apply to (iii) The course test blueprint. EPA for certification to engage in lead-

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based paint activities pursuant to this mental field (e.g., safety professional, section on or after March 1, 1999. environmental scientist); or (3) Following the submission of an (4) A high school diploma (or equiva- application demonstrating that all the lent), and at least 3 years of experience requirements of this section have been in a related field (e.g., lead, asbestos, meet, EPA shall certify an applicant as environmental remediation work or an inspector, risk assessor, supervisor, construction). project designer, or abatement worker, (C) Supervisor: (1) One year of experi- as appropriate. ence as a certified lead-based paint (4) Upon receiving EPA certification, abatement worker; or individuals conducting lead-based (2) At least 2 years of experience in a paint activities shall comply with the related field (e.g., lead, asbestos, or en- work practice standards for performing vironmental remediation work) or in the appropriate lead-based paint activi- the building trades. ties as established in § 745.227. (2) The following documents shall be (5) It shall be a violation of TSCA for recognized by EPA as evidence of meet- an individual to conduct any of the ing the requirements listed in (b)(2)(iii) lead-based paint activities described in of this paragraph: § 745.227 after March 1, 2000, if that indi- (i) Official academic transcripts or vidual has not been certified by EPA diploma, as evidence of meeting the pursuant to this section to do so. education requirements. (6) Individuals applying for certifi- (ii) Resumes, letters of reference, or cation must submit the appropriate documentation of work experience, as fees in accordance with § 745.238. evidence of meeting the work experi- (b) Inspector, risk assessor or super- ence requirements. visor. (1) To become certified by EPA as (iii) Course completion certificates an inspector, risk assessor, or super- from lead-specific or other related visor, pursuant to paragraph (a)(1)(i) of training courses, issued by accredited this section, an individual must: training programs, as evidence of (i) Successfully complete an accred- meeting the training requirements. ited course in the appropriate dis- (3) In order to take the certification cipline and receive a course completion examination for a particular discipline certificate from an accredited training an individual must: program. (i) Successfully complete an accred- (ii) Pass the certification exam in the ited course in the appropriate dis- appropriate discipline offered by EPA; cipline and receive a course completion and, certificate from an accredited training (iii) Meet or exceed the following ex- program. perience and/or education require- (ii) Meet or exceed the education and/ ments: or experience requirements in para- (A) Inspectors. (1) No additional expe- graph (b)(1)(iii) of this section. rience and/or education requirements. (4) The course completion certificate (2) [Reserved] shall serve as interim certification for (B) Risk assessors. (1) Successful an individual until the next available completion of an accredited training opportunity to take the certification course for inspectors; and exam. Such interim certification shall (2) Bachelor’s degree and 1 year of ex- expire 6 months after issuance. perience in a related field (e.g., lead, (5) After passing the appropriate cer- asbestos, environmental remediation tification exam and submitting an ap- work, or construction), or an Associ- plication demonstrating that he/she ates degree and 2 years experience in a meets the appropriate training, edu- related field (e.g., lead, asbestos, envi- cation, and/or experience prerequisites ronmental remediation work, or con- described in paragraph (b)(1) of this struction); or section, an individual shall be issued a (3) Certification as an industrial hy- certificate by EPA. To maintain cer- gienist, professional engineer, reg- tification, an individual must be re- istered architect and/or certification in certified as described in paragraph (e) a related engineering/health/environ- of this section.

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(6) An individual may take the cer- ceived, but shall be valid for no more tification exam no more than three than 6 months from the date of comple- times within 6 months of receiving a tion. course completion certificate. (4) After successfully completing the (7) If an individual does not pass the appropriate training courses and meet- certification exam and receive a cer- ing any other qualifications described tificate within 6 months of receiving in paragraph (c)(1) of this section, an his/her course completion certificate, individual shall be issued a certificate the individual must retake the appro- from EPA. To maintain certification, priate course from an accredited train- an individual must be re-certified as ing program before reapplying for cer- described in paragraph (e) of this sec- tification from EPA. tion. (c) Abatement worker and project de- (d) Certification based on prior training. signer. (1) To become certified by EPA (1) Any individual who received train- as an abatement worker or project de- ing in a lead-based paint activity be- signer, pursuant to paragraph (a)(1)(i) tween October 1, 1990, and March 1, 1999 of this section, an individual must: shall be eligible for certification by (i) Successfully complete an accred- EPA under the alternative procedures ited course in the appropriate dis- contained in this paragraph. Individ- cipline and receive a course completion uals who have received lead-based certificate from an accredited training paint activities training at an EPA-au- program. thorized State or Tribal accredited (ii) Meet or exceed the following ad- training program shall also be eligible ditional experience and/or education for certification by EPA under the fol- requirements: lowing alternative procedures: (A) Abatement workers. (1) No addi- (i) Applicants for certification as an tional experience and/or education re- inspector, risk assessor, or supervisor quirements. shall: (2) [Reserved] (A) Demonstrate that the applicant (B) Project designers. (1) Successful has successfully completed training or completion of an accredited training on-the-job training in the conduct of a course for supervisors. lead-based paint activity. (2) Bachelor’s degree in engineering, (B) Demonstrate that the applicant architecture, or a related profession, meets or exceeds the education and/or and 1 year of experience in building experience requirements in paragraph construction and design or a related (b)(1)(iii) of this section. field; or (C) Successfully complete an accred- (3) Four years of experience in build- ited refresher training course for the ing construction and design or a re- appropriate discipline. lated field. (D) Pass a certification exam admin- (2) The following documents shall be istered by EPA for the appropriate dis- recognized by EPA as evidence of meet- cipline. ing the requirements listed in this (ii) Applicants for certification as an paragraph: abatement worker or project designer (i) Official academic transcripts or shall: diploma, as evidence of meeting the (A) Demonstrate that the applicant education requirements. has successfully completed training or (ii) Resumes, letters of reference, or on-the-job training in the conduct of a documentation of work experience, as lead-based paint activity. evidence of meeting the work experi- (B) Demonstrate that the applicant ence requirements. meets the education and/or experience (iii) Course completion certificates requirements in paragraphs (c)(1) of from lead-specific or other related this section; and training courses, issued by accredited (C) Successfully complete an accred- training programs, as evidence of ited refresher training course for the meeting the training requirements. appropriate discipline. (3) The course completion certificate (2) Individuals shall have until March shall serve as an interim certification 1, 2000, to apply to EPA for certifi- until certification from EPA is re- cation under the above procedures.

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After that date, all individuals wishing (6) Firms applying for certification to obtain certification must do so must submit the appropriate fees in ac- through the procedures described in cordance with § 745.238. paragraph (a), and paragraph (b) or (c) (7) To maintain certification a firm of this section, according to the dis- shall submit appropriate fees in ac- cipline for which certification is being cordance with § 745.238 every 3 years. sought. (g) Suspension, revocation, and modi- (e) Re-certification. (1) To maintain fication of certifications of individuals en- certification in a particular discipline, gaged in lead-based paint activities. (1) a certified individual shall apply to and EPA may, after notice and opportunity be re-certified by EPA in that dis- for hearing, suspend, revoke, or modify cipline by EPA either: an individual’s certification if an individual has: (i) Every 3 years if the individual (i) Obtained training documentation completed a training course with a through fraudulent means. course test and hands-on assessment; (ii) Gained admission to and com- or pleted an accredited training program (ii) Every 5 years if the individual through misrepresentation of admis- completed a training course with a pro- sion requirements. ficiency test. (iii) Obtained certification through (2) An individual shall be re-certified misrepresentation of certification re- if the individual successfully completes quirements or related documents deal- the appropriate accredited refresher ing with education, training, profes- training course and submits a valid sional registration, or experience. copy of the appropriate refresher (iv) Performed work requiring certifi- course completion certificate. cation at a job site without having (3) Individuals applying for re-certifi- proof of certification. cation must submit the appropriate (v) Permitted the duplication or use fees in accordance with § 745.238. of the individual’s own certificate by (f) Certification of firms. (1) All firms another. which perform or offer to perform any (vi) Performed work for which cer- of the lead-based paint activities de- tification is required, but for which ap- scribed in § 745.227 after March 1, 2000, propriate certification has not been re- shall be certified by EPA. ceived. (2) A firm seeking certification shall (vii) Failed to comply with the ap- submit to EPA a letter attesting that propriate work practice standards for the firm shall only employ appro- lead-based paint activities at § 745.227. priately certified employees to conduct (viii) Failed to comply with Federal, lead-based paint activities, and that State, or local lead-based paint stat- the firm and its employees shall follow utes or regulations. the work practice standards in § 745.227 (2) In addition to an administrative or judicial finding of violation, for pur- for conducting lead-based paint activi- poses of this section only, execution of ties. a consent agreement in settlement of (3) From the date of receiving the an enforcement action constitutes evi- firm’s letter requesting certification, dence of a failure to comply with rel- EPA shall have 90 days to approve or evant statutes or regulations. disapprove the firm’s request for cer- (h) Suspension, revocation, and modi- tification. Within that time, EPA shall fication of certifications of firms engaged respond with either a certificate of ap- in lead-based paint activities. (1) EPA proval or a letter describing the rea- may, after notice and opportunity for sons for a disapproval. hearing, suspend, revoke, or modify a (4) The firm shall maintain all firm’s certification if a firm has: records pursuant to the requirements (i) Performed work requiring certifi- in § 745.227. cation at a job site with individuals (5) Firms may first apply to EPA for who are not certified. certification to engage in lead-based (ii) Failed to comply with the work paint activities pursuant to this sec- practice standards established in tion on or after March 1, 1999. § 745.227.

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(iii) Misrepresented facts in its letter (i) Conduct a fair, orderly, and impar- of application for certification to EPA. tial hearing within 90 days of the re- (iv) Failed to maintain required quest for a hearing; records. (ii) Consider all relevant evidence, (v) Failed to comply with Federal, explanation, comment, and argument State, or local lead-based paint stat- submitted; and utes or regulations. (iii) Notify the affected entity in (2) In addition to an administrative writing within 90 days of completion of or judicial finding of violation, for pur- the hearing of his or her decision and poses of this section only, execution of order. Such an order is a final EPA ac- a consent agreement in settlement of tion subject to judicial review. an enforcement action constitutes evi- (4) If EPA determines that the public dence of a failure to comply with rel- health, interest, or welfare warrants evant statutes or regulations. immediate action to suspend the cer- (i) Procedures for suspension, revoca- tification of any individual or firm tion, or modification of the certification of prior to the opportunity for a hearing, individuals or firms. it shall: (1) If EPA decides to suspend, revoke, (i) Notify the affected entity of its in- or modify the certification of any indi- tent to immediately suspend certifi- vidual or firm, it shall notify the af- cation for the reasons listed in para- fected entity in writing of the fol- graph (h)(1) of this section. If a suspen- lowing: sion, revocation, or modification no- (i) The legal and factual basis for the tice has not previously been issued, it suspension, revocation, or modifica- shall be issued at the same time the tion. immediate suspension notice is issued. (ii) The commencement date and du- (ii) Notify the affected entity in writ- ration of the suspension, revocation, or ing of the grounds upon which the im- modification. mediate suspension is based and why it (iii) Actions, if any, which the af- is necessary to suspend the entity’s ac- fected entity may take to avoid sus- creditation before an opportunity for a pension, revocation, or modification or hearing to suspend, revoke, or modify to receive certification in the future. the individual’s or firm’s certification. (iv) The opportunity and method for (iii) Notify the affected entity of the requesting a hearing prior to final EPA commencement date and duration of action to suspend, revoke, or modify the immediate suspension. certification. (iv) Notify the affected entity of its (v) Any additional information, as right to request a hearing on the im- appropriate, which EPA may provide. mediate suspension within 15 days of (2) If a hearing is requested by the the suspension taking place and the certified individual or firm, EPA shall: procedures for the conduct of such a (i) Provide the affected entity an op- hearing. portunity to offer written statements in response to EPA’s assertion of the (5) Any notice, decision, or order legal and factual basis and any other issued by EPA under this section, tran- explanations, comments, and argu- script or other verbatim record of oral ments it deems relevant to the pro- testimony, and any documents filed by posed action. a certified individual or firm in a hear- (ii) Provide the affected entity such ing under this section shall be avail- other procedural opportunities as EPA able to the public, except as otherwise may deem appropriate to ensure a fair provided by section 14 of TSCA or by and impartial hearing. part 2 of this title. Any such hearing at (iii) Appoint an official of EPA as which oral testimony is presented shall Presiding Officer to conduct the hear- be open to the public, except that the ing. No person shall serve as Presiding Presiding Officer may exclude the pub- Officer if he or she has had any prior lic to the extent necessary to allow connection with the specific matter. presentation of information which may (3) The Presiding Officer shall: be entitled to confidential treatment

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under section 14 of TSCA or part 2 of (i) In a residential dwelling and this title. child-occupied facility, each compo- [61 FR 45813, Aug. 29, 1996, as amended at 64 nent with a distinct painting history FR 31098, June 9, 1999; 64 FR 42851, Aug. 6, and each exterior component with a 1999] distinct painting history shall be tested for lead-based paint, except those § 745.227 Work practice standards for components that the inspector or risk conducting lead-based paint activi- assessor determines to have been re- ties: target housing and child-occu- placed after 1978, or to not contain pied facilities. lead-based paint; and (a) Effective date, applicability, and (ii) In a multi-family dwelling or terms. (1) Beginning on March 1, 2000, child-occupied facility, each compo- all lead-based paint activities shall be nent with a distinct painting history in performed pursuant to the work prac- every common area, except those com- tice standards contained in this sec- ponents that the inspector or risk as- tion. sessor determines to have been re- (2) When performing any lead-based placed after 1978, or to not contain paint activity described by the cer- lead-based paint. tified individual as an inspection, lead- (3) Paint shall be sampled in the fol- hazard screen, risk assessment or lowing manner: (i) The analysis of abatement, a certified individual must perform that activity in compliance paint to determine the presence of lead with the appropriate requirements shall be conducted using documented below. methodologies which incorporate ade- (3) Documented methodologies that quate quality control procedures; and/ are appropriate for this section are or found in the following: The U.S. De- (ii) All collected paint chip samples partment of Housing and Urban Devel- shall be analyzed according to para- opment (HUD) Guidelines for the Eval- graph (f) of this section to determine if uation and Control of Lead-Based they contain detectable levels of lead Paint Hazards in Housing; the EPA that can be quantified numerically. Guidance on Residential Lead-Based (4) The certified inspector or risk as- Paint, Lead-Contaminated Dust, and sessor shall prepare an inspection re- Lead-Contaminated Soil; the EPA Res- port which shall include the following idential Sampling for Lead: Protocols information: for Dust and Soil Sampling (EPA re- (i) Date of each inspection. port number 7474–R–95–001); Regula- (ii) Address of building. tions, guidance, methods or protocols (iii) Date of construction. issued by States and Indian Tribes that (iv) Apartment numbers (if applica- have been authorized by EPA; and ble). other equivalent methods and (v) Name, address, and telephone quidelines. number of the owner or owners of each (4) Clearance levels are appropriate residential dwelling or child-occupied for the purposes of this section may be facility. found in the EPA Guidance on Residen- tial Lead-Based Paint, Lead-Contami- (vi) Name, signature, and certifi- nated Dust, and Lead Contaminiated cation number of each certified inspec- Soil or other equivalent guidelines. tor and/or risk assessor conducting (b) Inspection. (1) An inspection shall testing. be conducted only by a person certified (vii) Name, address, and telephone by EPA as an inspector or risk assessor number of the certified firm employing and, if conducted, must be conducted each inspector and/or risk assessor, if according to the procedures in this applicable. paragraph. (viii) Each testing method and device (2) When conducting an inspection, and/or sampling procedure employed the following locations shall be se- for paint analysis, including quality lected according to documented meth- control data and, if used, the serial odologies and tested for the presence of number of any x-ray fluorescence lead-based paint: (XRF) device.

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(ix) Specific locations of each painted (4) Paint shall be sampled in the fol- component tested for the presence of lowing manner: (i) The analysis of lead-based paint. paint to determine the presence of lead (x) The results of the inspection ex- shall be conducted using documented pressed in terms appropriate to the methodologies which incorporate ade- sampling method used. quate quality control procedures; and/ (c) Lead hazard screen. (1) A lead haz- or ard screen shall be conducted only by a (ii) All collected paint chip samples person certified by EPA as a risk asses- shall be analyzed according to para- sor. graph (f) of this section to determine if (2) If conducted, a lead hazard screen they contain detectable levels of lead shall be conducted as follows: that can be quantified numerically. (i) Background information regard- (5) The risk assessor shall prepare a ing the physical characteristics of the lead hazard screen report, which shall residential dwelling or child-occupied include the following information: facility and occupant use patterns that (i) The information required in a risk may cause lead-based paint exposure to assessment report as specified in para- one or more children age 6 years and graph (d) of this section, including under shall be collected. paragraphs (d)(11)(i) through (ii) A visual inspection of the resi- (d)(11)(xiv), and excluding paragraphs dential dwelling or child-occupied fa- (d)(11)(xv) through (d)(11)(xviii) of this cility shall be conducted to: section. Additionally, any background (A) Determine if any deteriorated information collected pursuant to paint is present, and paragraph (c)(2)(i) of this section shall (B) Locate at least two dust sampling be included in the risk assessment re- locations. port; and (iii) If deteriorated paint is present, (ii) Recommendations, if warranted, each surface with deteriorated paint, for a follow-up risk assessment, and as which is determined, using documented appropriate, any further actions. methodologies, to be in poor condition (d) Risk assessment. (1) A risk assess- and to have a distinct painting history, ment shall be conducted only by a per- shall be tested for the presence of lead. son certified by EPA as a risk assessor (iv) In residential dwellings, two and, if conducted, must be conducted composite dust samples shall be col- according to the procedures in this lected, one from the floors and the paragraph. other from the windows, in rooms, hall- (2) A visual inspection for risk assess- ways or stairwells where one or more ment of the residential dwelling or children, age 6 and under, are most child-occupied facility shall be under- likely to come in contact with dust. taken to locate the existence of dete- (v) In multi-family dwellings and riorated paint, assess the extent and child-occupied facilities, in addition to causes of the deterioration, and other the floor and window samples required potential lead-based paint hazards. in paragraph (c)(1)(iii) of this section, (3) Background information regard- the risk assessor shall also collect ing the physical characteristics of the composite dust samples from common residential dwelling or child-occupied areas where one or more children, age facility and occupant use patterns that 6 and under, are most likely to come may cause lead-based paint exposure to into contact with dust. one or more children age 6 years and (3) Dust samples shall be collected under shall be collected. and analyzed in the following manner: (4) The following surfaces which are (i) All dust samples shall be taken determined, using documented meth- using documented methodologies that odologies, to have a distinct painting incorporate adequate quality control history, shall be tested for the presence procedures. of lead: (ii) All collected dust samples shall (i) Each friction surface or impact be analyzed according to paragraph (f) surface with visibly deteriorated paint; of this section to determine if they and contain detectable levels of lead that (ii) All other surfaces with visibly de- can be quantified numerically. teriorated paint.

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(5) In residential dwellings, dust sam- shall include the following informa- ples (either composite or single-surface tion: samples) from the interior window (i) Date of assessment. sill(s) and floor shall be collected and (ii) Address of each building. analyzed for lead concentration in all (iii) Date of construction of build- living areas where one or more chil- ings. dren, age 6 and under, are most likely (iv) Apartment number (if applica- to come into contact with dust. ble). (6) For multi-family dwellings and (v) Name, address, and telephone child-occupied facilities, the samples number of each owner of each building. required in paragraph (d)(4) of this sec- (vi) Name, signature, and certifi- tion shall be taken. In addition, inte- cation of the certified risk assessor rior window sill and floor dust samples conducting the assessment. (either composite or single-surface (vii) Name, address, and telephone samples) shall be collected and ana- number of the certified firm employing lyzed for lead concentration in the fol- each certified risk assessor if applica- lowing locations: ble. (i) Common areas adjacent to the (viii) Name, address, and telephone sampled residential dwelling or child- number of each recognized laboratory occupied facility; and conducting analysis of collected sam- (ii) Other common areas in the build- ples. ing where the risk assessor determines (ix) Results of the visual inspection. that one or more children, age 6 and (x) Testing method and sampling pro- under, are likely to come into contact cedure for paint analysis employed. with dust. (xi) Specific locations of each painted (7) For child-occupied facilities, inte- component tested for the presence of rior window sill and floor dust samples lead. (either composite or single-surface (xii) All data collected from on-site samples) shall be collected and ana- testing, including quality control data lyzed for lead concentration in each and, if used, the serial number of any room, hallway or stairwell utilized by XRF device. one or more children, age 6 and under, (xiii) All results of laboratory anal- and in other common areas in the ysis on collected paint, soil, and dust child-occupied facility where one or samples. more children, age 6 and under, are (xiv) Any other sampling results. likely to come into contact with dust. (xv) Any background information collected pursuant to paragraph (d)(3) (8) Soil samples shall be collected of this section. and analyzed for lead concentrations in (xvi) To the extent that they are used the following locations: as part of the lead-based paint hazard (i) Exterior play areas where bare determination, the results of any pre- soil is present; and vious inspections or analyses for the (ii) The rest of the yard (i.e., non- presence of lead-based paint, or other play areas) where bare soil is present. assessments of lead-based paint-related (iii) Dripline/foundation areas where hazards. bare soil is present. (xvii) A description of the location, (9) Any paint, dust, or soil sampling type, and severity of identified lead- or testing shall be conducted using doc- based paint hazards and any other po- umented methodologies that incor- tential lead hazards. porate adequate quality control proce- (xviii) A description of interim con- dures. trols and/or abatement options for each (10) Any collected paint chip, dust, or identified lead-based paint hazard and soil samples shall be analyzed accord- a suggested prioritization for addressing to paragraph (f) of this section to ing each hazard. If the use of an determine if they contain detectable encapsulant or enclosure is rec- levels of lead that can be quantified ommended, the report shall rec- numerically. ommend a maintenance and moni- (11) The certified risk assessor shall toring schedule for the encapsulant or prepare a risk assessment report which enclosure.

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(e) Abatement. (1) An abatement shall the start date specified in the original be conducted only by an individual cer- notification, as follows: tified by EPA, and if conducted, shall (A) For lead-based paint abatement be conducted according to the proce- activities beginning prior to the start dures in this paragraph. date provided to EPA an updated noti- (2) A certified supervisor is required fication must be received by EPA at for each abatement project and shall be least 5 business days before the new onsite during all work site preparation start date included in the notification. and during the post-abatement cleanup (B) For lead-based paint abatement of work areas. At all other times when activities beginning after the start abatement activities are being con- date provided to EPA an updated noti- ducted, the certified supervisor shall be fication must be received by EPA on or onsite or available by telephone, pager before the start date provided to EPA. or answering service, and able to be (iv) Except as provided in paragraph present at the work site in no more (e)(4)(ii) of this section, updated notifi- than 2 hours. cation must be provided to EPA for (3) The certified supervisor and the any change in location of lead-based certified firm employing that super- paint abatement activities at least 5 visor shall ensure that all abatement business days prior to the start date activities are conducted according to provided to EPA. the requirements of this section and all (v) Updated notification must be pro- other Federal, State and local require- vided to EPA when lead-based paint ments. abatement activities are canceled, or (4) A certified firm must notify EPA when there are other significant of lead-based paint abatement activi- changes including, but not limited to, ties as follows: when the square footage or acreage to (i) Except as provided in paragraph be abated changes by more than 20%. (e)(4)(ii) of this section, EPA must be This updated notification must be re- notified prior to conducting lead-based ceived by EPA on or before the start paint abatement activities. The origi- date provided to EPA, or if work has nal notification must be received by already begun, within 24 hours of the EPA at least 5 business days before the change. start date of any lead-based paint (vi) The following must be included abatement activities. in each notification: (ii) Notification for lead-based paint (A) Notification type (original, up- abatement activities required in re- dated, cancellation). sponse to an elevated blood lead level (B) Date when lead-based paint (EBL) determination, or Federal, abatement activities will start. State, Tribal, or local emergency abatement order should be received by (C) Date when lead-based paint abate- EPA as early as possible before, but ment activities will end (approxima- must be received no later than the tion using best professional judge- start date of the lead-based paint ment). abatement activities. Should the start (D) Firm’s name, EPA certification date and/or location provided to EPA number, address, telephone number. change, an updated notification must (E) Type of building (e.g., single fam- be received by EPA on or before the ily dwelling, multi-family dwelling, start date provided to EPA. Docu- child-occupied facilities) on/in which mentation showing evidence of an EBL abatement work will be performed. determination or a copy of the Federal/ (F) Property name (if applicable). State/Tribal/local emergency abate- (G) Property address including apartment order must be included in the ment or unit number(s) (if applicable) written notification to take advantage for abatement work. of this abbreviated notification period. (H) Documentation showing evidence (iii) Except as provided in paragraph of an EBL determination or a copy of (e)(4)(ii) of this section, updated notifi- the Federal/State/Tribal/local emer- cation must be provided to EPA for gency abatement order, if using the ab- lead-based paint abatement activities breviated time period as described in that will begin on a date other than paragraph (e)(4)(ii) of this section.

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(I) Name and EPA certification num- (ii) A certified supervisor or project ber of the project supervisor. designer shall prepare the occupant (J) Approximate square footage/acre- protection plan. age to be abated. (6) The work practices listed below (K) Brief description of abatement shall be restricted during an abatement activities to be performed. as follows: (L) Name, title, and signature of the (i) Open-flame burning or torching of representative of the certified firm who lead-based paint is prohibited; prepared the notification. (ii) Machine sanding or grinding or (vii) Notification must be accom- abrasive blasting or sandblasting of plished using any of the following lead-based paint is prohibited unless methods: Written notification, or elec- used with High Efficiency Particulate tronically using the Agency’s Central Air (HEPA) exhaust control which re- Data Exchange (CDX). Written notifi- moves particles of 0.3 microns or larger cation can be accomplished using ei- from the air at 99.97 percent or greater ther the sample form titled ‘‘Notifica- efficiency; tion of Lead-Based Paint Abatement (iii) Dry scraping of lead-based paint Activities’’ or similar form containing is permitted only in conjunction with the information required in paragraph heat guns or around electrical outlets (e)(4)(vi) of this section. All written no- or when treating defective paint spots tifications must be delivered by U.S. totaling no more than 2 square feet in Postal Service, fax, commercial deliv- any one room, hallway or stairwell or ery service, or hand delivery (persons submitting notification by U.S. Postal totaling no more than 20 square feet on Service are reminded that they should exterior surfaces; and allow 3 additional business days for de- (iv) Operating a heat gun on lead- livery in order to ensure that EPA re- based paint is permitted only at tem- ceives the notification by the required peratures below 1100 degrees Fahr- date). Instructions and sample forms enheit. can be obtained from the NLIC at 1– (7) If conducted, soil abatement shall 800–424–LEAD(5323), or on the Internet be conducted in one of the following at http://www.epa.gov/lead. ways: (viii) Lead-based paint abatement ac- (i) If the soil is removed: tivities shall not begin on a date, or at (A) The soil shall be replaced by soil a location other than that specified in with a lead concentration as close to either an original or updated notifica- local background as practicable, but no tion, in the event of changes to the greater than 400 ppm. original notification. (B) The soil that is removed shall not (ix) No firm or individual shall en- be used as top soil at another residen- gage in lead-based paint abatement ac- tial property or child-occupied facility. tivities, as defined in § 745.223, prior to (ii) If soil is not removed, the soil notifying EPA of such activities ac- shall be permanently covered, as de- cording to the requirements of this fined in § 745.223. paragraph. (8) The following post-abatement (5) A written occupant protection clearance procedures shall be per- plan shall be developed for all abate- formed only by a certified inspector or ment projects and shall be prepared according to the following procedures: risk assessor: (i) The occupant protection plan (i) Following an abatement, a visual shall be unique to each residential inspection shall be performed to deter- dwelling or child-occupied facility and mine if deteriorated painted surfaces be developed prior to the abatement. and/or visible amounts of dust, debris The occupant protection plan shall de- or residue are still present. If deterio- scribe the measures and management rated painted surfaces or visible procedures that will be taken during amounts of dust, debris or residue are the abatement to protect the building present, these conditions must be occupants from exposure to any lead- eliminated prior to the continuation of based paint hazards. the clearance procedures.

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(ii) Following the visual inspection conducted to determine the presence of and any post-abatement cleanup re- paint chips on the dripline or next to quired by paragraph (e)(8)(i) of this sec- the foundation below any exterior sur- tion, clearance sampling for lead in face abated. If paint chips are present, dust shall be conducted. Clearance they must be removed from the site sampling may be conducted by employ- and properly disposed of, according to ing single-surface sampling or com- all applicable Federal, State and local posite sampling techniques. requirements. (iii) Dust samples for clearance pur- (vi) The rooms, hallways or stair- poses shall be taken using documented wells selected for sampling shall be se- methodologies that incorporate ade- lected according to documented meth- quate quality control procedures. odologies. (iv) Dust samples for clearance pur- (vii) The certified inspector or risk poses shall be taken a minimum of 1 assessor shall compare the residual hour after completion of final post- lead level (as determined by the labora- abatement cleanup activities. tory analysis) from each single surface (v) The following post-abatement dust sample with clearance levels in clearance activities shall be conducted paragraph (e)(8)(viii) of this section for as appropriate based upon the extent or lead in dust on floors, interior window manner of abatement activities con- sills, and window troughs or from each ducted in or to the residential dwelling composite dust sample with the appli- or child-occupied facility: cable clearance levels for lead in dust (A) After conducting an abatement on floors, interior window sills, and with containment between abated and window troughs divided by half the unabated areas, one dust sample shall number of subsamples in the composite be taken from one interior window sill sample. If the residual lead level in a and from one window trough (if single surface dust sample equals or ex- present) and one dust sample shall be ceeds the applicable clearance level or taken from the floors of each of no less if the residual lead level in a composite than four rooms, hallways or stairwells dust sample equals or exceeds the ap- within the containment area. In addi- plicable clearance level divided by half tion, one dust sample shall be taken the number of subsamples in the com- from the floor outside the containment posite sample, the components rep- area. If there are less than four rooms, resented by the failed sample shall be hallways or stairwells within the con- recleaned and retested. tainment area, then all rooms, hall- (viii) The clearance levels for lead in ways or stairwells shall be sampled. dust are 40 μg/ft2 for floors, 250 μg/ft2 for (B) After conducting an abatement interior window sills, and 400 μg/ft2 for with no containment, two dust samples window troughs. shall be taken from each of no less (9) In a multi-family dwelling with than four rooms, hallways or stairwells similarly constructed and maintained in the residential dwelling or child-oc- residential dwellings, random sampling cupied facility. One dust sample shall for the purposes of clearance may be be taken from one interior window sill conducted provided: and window trough (if present) and one (i) The certified individuals who dust sample shall be taken from the abate or clean the residential dwellings floor of each room, hallway or stairwell do not know which residential dwelling selected. If there are less than four will be selected for the random sample. rooms, hallways or stairwells within (ii) A sufficient number of residential the residential dwelling or child-occu- dwellings are selected for dust sam- pied facility then all rooms, hallways pling to provide a 95 percent level of or stairwells shall be sampled. confidence that no more than 5 percent (C) Following an exterior paint or 50 of the residential dwellings abatement, a visible inspection shall be (whichever is smaller) in the randomly conducted. All horizontal surfaces in sampled population exceed the appro- the outdoor living area closest to the priate clearance levels. abated surface shall be found to be (iii) The randomly selected residen- cleaned of visible dust and debris. In tial dwellings shall be sampled and addition, a visual inspection shall be evaluated for clearance according to

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the procedures found in paragraph (h) Determinations. (1) Lead-based (e)(8) of this section. paint is present: (10) An abatement report shall be (i) On any surface that is tested and prepared by a certified supervisor or found to contain lead equal to or in ex- project designer. The abatement report cess of 1.0 milligrams per square centi- shall include the following informa- meter or equal to or in excess of 0.5% tion: by weight; and (i) Start and completion dates of (ii) On any surface like a surface abatement. tested in the same room equivalent (ii) The name and address of each cer- that has a similar painting history and tified firm conducting the abatement that is found to be lead-based paint. and the name of each supervisor as- (2) A paint-lead hazard is present: signed to the abatement project. (i) On any friction surface that is (iii) The occupant protection plan subject to abrasion and where the lead prepared pursuant to paragraph (e)(5) dust levels on the nearest horizontal of this section. surface underneath the friction surface (iv) The name, address, and signature (e.g., the window sill or floor) are equal of each certified risk assessor or in- to or greater than the dust hazard lev- spector conducting clearance sampling els identified in § 745.227(b); and the date of clearance testing. (ii) On any chewable lead-based paint (v) The results of clearance testing surface on which there is evidence of and all soil analyses (if applicable) and teeth marks; the name of each recognized laboratory (iii) Where there is any damaged or that conducted the analyses. otherwise deteriorated lead-based paint (vi) A detailed written description of on an impact surface that is cause by the abatement, including abatement impact from a related building compo- methods used, locations of rooms and/ nent (such as a door knob that knocks or components where abatement oc- into a wall or a door that knocks curred, reason for selecting particular against its door frame; and abatement methods for each compo- (iv) If there is any other deteriorated nent, and any suggested monitoring of lead-based paint in any residential encapsulants or enclosures. building or child-occupied facility or (f) Collection and laboratory analysis of on the exterior of any residential build- samples. Any paint chip, dust, or soil ing or child-occupied facility. samples collected pursuant to the work (3) A dust-lead hazard is present in a practice standards contained in this residential dwelling or child occupied section shall be: facility: (1) Collected by persons certified by (i) In a residential dwelling on floors EPA as an inspector or risk assessor; and interior window sills when the and weighted arithmetic mean lead loading (2) Analyzed by a laboratory recog- for all single surface or composite sam- nized by EPA pursuant to section 405(b) ples of floors and interior window sills of TSCA as being capable of performing are equal to or greater than 40 μg/ft2 for analyses for lead compounds in paint floors and 250 μg/ft2 for interior window chip, dust, and soil samples. sills, respectively; (g) Composite dust sampling. Com- (ii) On floors or interior window sills posite dust sampling may only be con- in an unsampled residential dwelling in ducted in the situations specified in a multi-family dwelling, if a dust-lead paragraphs (c) through (e) of this sec- hazard is present on floors or interior tion. If such sampling is conducted, the window sills, respectively, in at least following conditions shall apply: one sampled residential unit on the (1) Composite dust samples shall con- property; and sist of at least two subsamples; (iii) On floors or interior window sills (2) Every component that is being in an unsampled common area in a tested shall be included in the sam- multi-family dwelling, if a dust-lead pling; and hazard is present on floors or interior (3) Composite dust samples shall not window sills, respectively, in at least consist of subsamples from more than one sampled common area in the same one type of component. common area group on the property.

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(4) A soil-lead hazard is present: (b) Failure or refusal to establish, (i) In a play area when the soil-lead maintain, provide, copy, or permit ac- concentration from a composite play cess to records or reports as required area sample of bare soil is equal to or by §§ 745.225, 745.226, or 745.227 is a pro- greater than 400 parts per million; or hibited act under sections 15 and 409 of (ii) In the rest of the yard when the TSCA (15 U.S.C. 2614, 2689). arithmetic mean lead concentration (c) Failure or refusal to permit entry from a composite sample (or arith- or inspection as required by § 745.237 metic mean of composite samples) of and section 11 of TSCA (15 U.S.C. 2610) bare soil from the rest of the yard (i.e., is a prohibited act under sections 15 non-play areas) for each residential and 409 of TSCA (15 U.S.C. 2614, 2689). building on a property is equal to or (d) In addition to the above, any indi- greater than 1,200 parts per million. vidual or firm that performs any of the (i) Recordkeeping. All reports or plans following acts shall be deemed to have required in this section shall be main- committed a prohibited act under sec- tained by the certified firm or indi- tions 15 and 409 of TSCA (15 U.S.C. 2614, vidual who prepared the report for no 2689). These include the following: fewer than 3 years. The certified firm (i) Obtaining certification through or individual also shall provide copies fraudulent representation; of these reports to the building owner (ii) Failing to obtain certification who contracted for its services. from EPA and performing work requir- [61 FR 45813, Aug. 29, 1996, as amended at 64 ing certification at a job site; or FR 42852, Aug. 6, 1999; 66 FR 1239, Jan. 5, 2001; (iii) Fraudulently obtaining certifi- 69 FR 18496, Apr. 8, 2004] cation and engaging in any lead-based paint activities requiring certification. § 745.228 Accreditation of training pro- (e) Violators are subject to civil and grams: public and commercial criminal sanctions pursuant to section buildings, bridges and superstructures. [Reserved] 16 of TSCA (15 U.S.C. 2615) for each violation. § 745.229 Certification of individuals and firms engaged in lead-based § 745.237 Inspections. paint activities: public and commer- EPA may conduct reasonable inspec- cial buildings, bridges and super- tions pursuant to the provisions of sec- structures. [Reserved] tion 11 of TSCA (15 U.S.C. 2610) to en- § 745.230 Work practice standards for sure compliance with this subpart. conducting lead-based paint activities: public and commercial build- § 745.238 Fees for accreditation and ings, bridges and superstructures. certification of lead-based paint ac- [Reserved] tivities. (a) Purpose. To establish and impose § 745.233 Lead-based paint activities fees for certified individuals and firms requirements. engaged in lead-based paint activities Lead-based paint activities, as de- and persons operating accredited train- fined in this part, shall only be con- ing programs under section 402(a) of ducted according to the procedures and the Toxic Substances Control Act work practice standards contained in (TSCA). § 745.227 of this subpart. No individual (b) Persons who must pay fees. Fees in or firm may offer to perform or per- accordance with paragraph (c) of this form any lead-based paint activity as section must be paid by: defined in this part, unless certified to (1) Training programs. (i) All non-ex- perform that activity according to the empt training programs applying to procedures in § 745.226. EPA for the accreditation and re-accreditation of training programs in one § 745.235 Enforcement. or more of the following disciplines: in- (a) Failure or refusal to comply with spector, risk assessor, supervisor, any requirement of §§ 745.225, 745.226, project designer, abatement worker. 745.227, or 745.233 is a prohibited act (ii) Exemptions. No fee shall be im- under sections 15 and 409 of TSCA (15 posed on any training program oper- U.S.C. 2614, 2689). ated by a State, federally recognized

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Indian Tribe, local government, or non- one or more of the following dis- profit organization. This exemption ciplines: inspector, risk assessor, super- does not apply to the certification of visor, project designer, abatement firms or individuals. worker. (2) Firms and individuals. All firms (c) Fee amounts—(1) Certification and and individuals seeking certification accreditation fees. Initial and renewal and re-certification from EPA to en- certification and accreditation fees are gage in lead-based paint activities in specified in the following table:

Re-accreditation (every 4 years, Training Program Accreditation see 40 CFR 745.225(f)(1) for details)

Initial Course Inspector $870 $620 Risk assessor $870 $620 Supervisor $870 $620 Worker $870 $620 Project Designer $870 $620

Refresher Course Inspector $690 $580 Risk assessor $690 $580 Supervisor $690 $580 Worker $690 $580 Project Designer $690 $580

Lead-based Paint Activities—Individual Certification Re-certification (every 3 years, see 40 CFR 745.226(e)(1) for details)

Inspector $410 $410 Risk assessor $410 $410 Supervisor $410 $410 Worker $310 $310 Project designer $410 $410 Tribal certification (each discipline) $10 $10

Lead-based Paint Activities—Firm Certification Re-certification (every 3 years, see 40 CFR 745.226(f)(7) for details)

Firm $550 $550 Combined Renovation and Lead-based Paint Activi- $550 $550 ties Firm Application Combined Renovation and Lead-based Paint Activi- $20 $20 ties Tribal Firm Application Tribal Firm $20 $20

(2) Certification examination fee. Indi- istration fee, an EPA-administered ju- viduals required to take a certification risdiction is either an individual state exam in accordance with § 745.226 will without an authorized program or all be assessed a fee of $70 for each exam Indian Tribes without authorized pro- attempt. grams that are within a given EPA Re- (3) Multi-jurisdiction registration fee. gion. An individual, firm, or training pro- (4) Lost identification card or certifi- gram certified or accredited by EPA cate. A $15 fee shall be charged for re- may wish to provide training or per- placement of an identification card or form lead-based paint activities in ad- certificate. (See replacement procedure ditional EPA-administered jurisdic- in paragraph (e) of this section.) tions. A fee of $35 per discipline will be (d) Application/payment procedure—(1) assessed for each additional EPA-ad- Certification and re-certification in one or ministered jurisdiction in which an in- more EPA-administered jurisdiction—(i) dividual, firm, or training program ap- Individuals. Submit a completed appli- plies for certification/re-certification cation (titled ‘‘Application for Individ- or accreditation/re-accreditation. For uals to Conduct Lead-based Paint Ac- purposes of this multi-jurisdiction reg- tivities’’), the materials described at

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§ 745.226, and the application fee(s) de- tion for any individual, firm, or train- scribed in paragraph (c) of this section. ing program which does not remit fees (ii) Firms. Submit a completed appli- described in paragraph (c) of this sec- cation (titled ‘‘Application for Firms tion in accordance with the procedures ’’), the materials described at § 745.226, specified in paragraph (d) of this sec- and the application fee(s) described in tion. paragraph (c) of this section. (2) EPA will not replace identifica- (2) Accreditation and re-accreditation in tion cards or certificates for any indi- one or more EPA-administered jurisdic- vidual, firm, or training program which tion. Submit a completed application does not remit fees described in para- (titled ‘‘Accreditation Application for graph (c) of this section in accordance Training Programs’’), the materials de- with the procedures specified in para- scribed at § 745.225, and the application graph (e) of this section. fee described in paragraph (c) of this [64 FR 31098, June 9, 1999, as amended at 74 section. FR 11870, Mar. 20, 2009] (3) Application forms. Application forms and instructions can be obtained § 745.239 Effective dates. from the National Lead Information This subpart L shall apply in any Center at: 1–800–424–LEAD. State or Indian Country that does not (e) Identification card replacement and have an authorized program under sub- certificate replacement. (1) Parties seek- part Q, effective August 31, 1998. In ing identification card or certificate such States or Indian Country: replacement shall complete the appli- (a) Training programs shall not pro- cable portions of the appropriate appli- vide, offer or claim to provide training cation in accordance with the instruc- or refresher training for certification tions provided. The appropriate appli- without accreditation from EPA pursu- cations are: ant to § 745.225 on or after March 1, 1999. (i) Individuals. ‘‘Application for Indi- (b) No individual or firm shall per- viduals to Conduct Lead-based Paint form, offer, or claim to perform lead- Activities.’’ based paint activities, as defined in (ii) Firms. ‘‘Application for Firms.’’ this subpart, without certification (iii) Training programs. ‘‘Accredita- from EPA to conduct such activities tion Application for Training Pro- pursuant to § 745.226 on or after March grams.’’ 1, 2000. (2) Submit application and payment (c) All lead-based paint activities in the amount specified in paragraph shall be performed pursuant to the (c)(4) of this section in accordance with work practice standards contained in the instructions provided with the ap- § 745.227 on or after March 1, 2000. plication package. [61 FR 45813, Aug. 29, 1996, as amended at 64 (f) Adjustment of fees. (1) EPA will col- FR 42852, Aug. 6, 1999] lect fees reflecting the costs associated with the administration and enforcement of subpart L of this part with the Subparts M–P [Reserved] exception of costs associated with the accreditation of training programs op- Subpart Q—State and Indian Tribal erated by a State, federally recognized Programs Indian Tribe, local government, and nonprofit organization. In order to do SOURCE: 61 FR 45825, Aug. 29, 1996, unless this, EPA will periodically adjust the otherwise noted. fees to reflect changed economic conditions. § 745.320 Scope and purpose. (2) The fees will be evaluated based (a) This subpart establishes the re- on the cost to administer and enforce quirements that State or Tribal pro- the program, and the number of appli- grams must meet for authorization by cants. New fee schedules will be pub- the Administrator to administer and lished in the FEDERAL REGISTER. enforce the standards, regulations, or (g) Failure to remit a fee. (1) EPA will other requirements established under not provide certification, re-certifi- TSCA section 402 and/or section 406 and cation, accreditation, or re-accredita- establishes the procedures EPA will

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follow in approving, revising, and with- of the U.S. government, notwith- drawing approval of State or Tribal standing the issuance of any patent, programs. and including rights-of-way running (b) For State or Tribal lead-based throughout the reservation; (2) all de- paint training and certification pro- pendent Indian communities within the grams, a State or Indian Tribe may borders of the United States whether seek authorization to administer and within the original or subsequently ac- enforce §§ 745.225, 745.226, and 745.227. quired territory thereof, and whether The provisions of §§ 745.220, 745.223, within or outside the limits of a State; 745.233, 745.235, 745.237, and 745.239 shall and (3) all Indian allotments, the In- be applicable for the purposes of such dian titles which have not been extin- program authorization. guished, including rights-of-way run- (c) A State or Indian Tribe may seek ning through the same. authorization to administer and en- Indian Tribe means any Indian Tribe, force all of the provisions of subpart E band, nation, or community recognized of this part, just the pre-renovation by the Secretary of the Interior and ex- education provisions of subpart E of ercising substantial governmental du- this part, or just the training, certifi- ties and powers. cation, accreditation, and work practice provisions of subpart E of this § 745.324 Authorization of State or part. The provisions of §§ 745.324 and Tribal programs. 745.326 apply for the purposes of such program authorizations. (a) Application content and procedures. (d) A State or Indian Tribe applying (1) Any State or Indian Tribe that for program authorization may seek ei- seeks authorization from EPA to ad- ther interim approval or final approval minister and enforce the provisions of of the compliance and enforcement subpart E or subpart L of this part portion of the State or Tribal lead- must submit an application to the Ad- based paint program pursuant to the ministrator in accordance with this procedures at § 745.327(a). paragraph. (e) State or Tribal submissions for (2) Before developing an application program authorization shall comply for authorization, a State or Indian with the procedures set out in this sub- Tribe shall disseminate a public notice part. of intent to seek such authorization (f) Any State or Tribal program ap- and provide an opportunity for a public proved by the Administrator under this hearing. subpart shall at all times comply with (3) A State or Tribal application shall the requirements of this subpart. include: (g) In many cases States will lack au- (i) A transmittal letter from the thority to regulate activities in Indian State Governor or Tribal Chairperson Country. This lack of authority does (or equivalent official) requesting pro- not impair a State’s ability to obtain gram approval. full program authorization in accord- (ii) A summary of the State or Tribal ance with this subpart. EPA will ad- program. This summary will be used to minister the program in Indian Coun- provide notice to residents of the State try if neither the State nor Indian or Tribe. Tribe has been granted program au- (iii) A description of the State or thorization by EPA. Tribal program in accordance with [61 FR 45825, Aug. 29, 1996, as amended at 73 paragraph (b) of this section. FR 21767, Apr. 22, 2008] (iv) An Attorney General’s or Tribal Counsel’s (or equivalent) statement in § 745.323 Definitions. accordance with paragraph (c) of this The definitions in subpart A apply to section. this subpart. In addition, the defini- (v) Copies of all applicable State or tions in § 745.223 and the following defi- Tribal statutes, regulations, standards, nitions apply: and other materials that provide the Indian Country means (1) all land State or Indian Tribe with the author- within the limits of any American In- ity to administer and enforce a lead- dian reservation under the jurisdiction based paint program.

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(4) After submitting an application, section, the State or Tribal application the Agency will publish a FEDERAL must include: REGISTER notice that contains an an- (i) A description of the program that nouncement of the receipt of the State demonstrates that the program con- or Tribal application, the summary of tains all of the elements specified in the program as provided by the State § 745.325, § 745.326, or both; and or Tribe, and a request for public com- (ii) An analysis of the State or Tribal ments to be mailed to the appropriate program that compares the program to EPA Regional Office. This comment the Federal program in subpart E or period shall last for no less than 45 subpart L of this part, or both. This days. EPA will consider these com- analysis must demonstrate how the ments during its review of the State or program is, in the State’s or Indian Tribal application. Tribe’s assessment, at least as protec- (5) Within 60 days of submission of a tive as the elements in the Federal pro- State or Tribal application, EPA will, gram at subpart E or subpart L of this if requested, conduct a public hearing part, or both. EPA will use this anal- in each State or Indian Country seek- ysis to evaluate the protectiveness of ing program authorization and will the State or Tribal program in making consider all comments submitted at its determination pursuant to para- that hearing during the review of the graph (e)(2)(i) of this section. State or Tribal application. (3) To demonstrate that the State or (b) Program description. A State or In- Tribal program provides adequate en- dian Tribe seeking to administer and forcement, fulfilling the criteria in enforce a program under this subpart paragraph (e)(2)(ii) of this section, the must submit a description of the pro- State or Tribal application must in- gram. The description of the State or clude a description of the State or Tribal program must include: Tribal lead-based paint compliance and enforcement program that dem- (1)(i) The name of the State or Tribal onstrates that the program contains agency that is or will be responsible for all of the elements specified at § 745.327. administering and enforcing the pro- This description shall include copies of gram, the name of the official in that all policies, certifications, plans, re- agency designated as the point of con- ports, and other materials that dem- tact with EPA, and addresses and onstrate that the State or Tribal pro- phone numbers where this official can gram contains all of the elements spec- be contacted. ified at § 745.327. (ii) Where more than one agency is or (4)(i) The program description for an will be responsible for administering Indian Tribe shall also include a map, and enforcing the program, the State legal description, or other information or Indian Tribe must designate a pri- sufficient to identify the geographical mary agency to oversee and coordinate extent of the territory over which the administration and enforcement of the Indian Tribe exercises jurisdiction. program and serve as the primary con- (ii) The program description for an tact with EPA. Indian Tribe shall also include a dem- (iii) In the event that more than one onstration that the Indian Tribe: agency is or will be responsible for ad- (A) Is recognized by the Secretary of ministering and enforcing the program, the Interior. the application must also include a de- (B) has an existing government exer- scription of the functions to be per- cising substantial governmental duties formed by each agency. The desciption and powers. shall explain and how the program will (C) has adequate civil regulatory ju- be coordinated by the primary agency risdiction (as shown in the Tribal legal to ensure consistency and effective ad- certification in paragraph (c)(2) of this ministration of the within the State or section) over the subject matter and Indian Tribe. entities regulated. (2) To demonstrate that the State or (D) is reasonably expected to be capa- Tribal program is at least as protective ble of administering the Federal pro- as the Federal program, fulfilling the gram for which it is seeking authoriza- criteria in paragraph (e)(2)(i) of this tion.

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(iii) If the Administrator has pre- ing non-member fee lands within an In- viously determined that an Indian dian reservation. Tribe has met the prerequisites in (3) If the application does not contain paragraphs (b)(4)(ii)(A) and (B) of this such certification, the State program section for another EPA program, the will be authorized only after the Ad- Indian Tribe need provide only that in- ministrator authorizes the program in formation unique to the lead-based accordance with paragraph (e) of this paint program required by paragraphs section. (b)(4)(ii)(C) and (D) of this section. (4) This certification shall take the (c) Attorney General’s statement. (1) A form of a letter from the Governor or State or Indian Tribe must submit a the Attorney General to the Adminis- written statement signed by the Attor- trator. The certification shall ref- ney General or Tribal Counsel (or erence the program analysis in para- equivalent) certifying that the laws graph (b)(3) of this section as the basis and regulations of the State or Indian for concluding that the State program Tribe provide adequate legal authority is at least as protective as the Federal to administer and enforce the State or program, and provides adequate en- Tribal program. This statement shall forcement. include citations to the specific stat- (e) EPA approval. (1) EPA will fully utes and regulations providing that review and consider all portions of a legal authority. State or Tribal application. (2) The Tribal legal certification (the (2) Within 180 days of receipt of a equivalent to the Attorney General’s complete State or Tribal application, statement) may also be submitted and the Administrator shall either author- signed by an independent attorney re- ize the program or disapprove the ap- tained by the Indian Tribe for represen- plication. The Administrator shall au- tation in matters before EPA or the thorize the program, after notice and courts pertaining to the Indian Tribe’s the opportunity for public comment program. The certification shall in- and a public hearing, only if the Ad- clude an assertion that the attorney ministrator finds that: has the authority to represent the In- (i) The State or Tribal program is at dian Tribe with respect to the Indian least as protective of human health Tribe’s authorization application. and the environment as the cor- (3) If a State application seeks ap- responding Federal program under sub- proval of its program to operate in In- part E or subpart L of this part, or dian Country, the required legal cer- both; and tification shall include an analysis of (ii) The State or Tribal program pro- the applicant’s authority to implement vides adequate enforcement. its provisions in Indian Country. The (3) EPA shall notify in writing the applicant shall include a map delin- State or Indian Tribe of the Adminis- eating the area over which it seeks to trator’s decision to authorize the State operate the program. or Tribal program or disapprove the (d) Program certification. (1) At the State’s or Indian Tribe’s application. time of submitting an application, a (4) If the State or Indian Tribe ap- State may also certify to the Adminis- plies for authorization of State or Trib- trator that the State program meets al programs under both subpart E and the requirements contained in para- subpart L, EPA may, as appropriate, graphs (e)(2)(i) and (e)(2)(ii) of this sec- authorize one program and disapprove tion. the other. (2) If this certification is contained (f) EPA administration and enforce- in a State’s application, the program ment. (1) If a State or Indian Tribe does shall be deemed to be authorized by not have an authorized program to ad- EPA until such time as the Adminis- minister and enforce subpart L of this trator disapproves the program appli- part in effect by August 31, 1998, the cation or withdraws the program au- Administrator shall, by such date, es- thorization. A program shall not be tablish and enforce the provisions of deemed authorized pursuant to this subpart L of this part as the Federal subpart to the extent that jurisdiction program for that State or Indian Coun- is asserted over Indian Country, includ- try.

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(2) If a State or Indian Tribe does not (2) All information regarding the have an authorized program to admin- lead-based paint enforcement and com- ister and enforce the pre-renovation pliance activities listed at § 745.327(d) education requirements of subpart E of ‘‘Summary on Progress and Perform- this part by August 31, 1998, the Admin- ance.’’ istrator will, by such date, enforce (i) Withdrawal of authorization. (1) If those provisions of subpart E of this EPA concludes that a State or Indian part as the Federal program for that Tribe is not administering and enforc- State or Indian Country. If a State or ing an authorized program in compli- Indian Tribe does not have an author- ance with the standards, regulations, ized program to administer and enforce and other requirements of sections 401 the training, certification and accredi- through 412 of TSCA and this subpart, tation requirements and work practice the Administrator shall notify the pri- standards of subpart E of this part by mary agency for the State or Indian April 22, 2009, the Administrator will, Tribe in writing and indicate EPA’s in- by such date, enforce those provisions tent to withdraw authorization of the of subpart E of this part as the Federal program. program for that State or Indian Coun- (2) The Notice of Intent to Withdraw try. shall: (3) Upon authorization of a State or (i) Identify the program aspects that Tribal program, pursuant to paragraph EPA believes are inadequate and pro- (d) or (e) of this section, it shall be an vide a factual basis for such findings. unlawful act under sections 15 and 409 (ii) Include copies of relevant docu- of TSCA for any person to fail or refuse ments. to comply with any requirements of (iii) Provide an opportunity for the such program. State or Indian Tribe to respond either (g) Oversight. EPA shall periodically in writing or at a meeting with appro- evaluate the adequacy of a State’s or priate EPA officials. Indian Tribe’s implementation and en- (3) EPA may request that an infor- forcement of its authorized programs. mal conference be held between rep- (h) Reports. Beginning 12 months resentatives of the State or Indian after the date of program authoriza- Tribe and EPA officials. tion, the primary agency for each (4) Prior to issuance of a withdrawal, State or Indian Tribe that has an au- a State or Indian Tribe may request thorized program shall submit a writ- that EPA hold a public hearing. At this ten report to the EPA Regional Admin- hearing, EPA, the State or Indian istrator for the Region in which the Tribe, and the public may present facts State or Indian Tribe is located. This bearing on whether the State’s or In- report shall be submitted at least once dian Tribe’s authorization should be every 12 months for the first 3 years withdrawn. after program authorization. If these (5) If EPA finds that deficiencies war- reports demonstrate successful pro- ranting withdrawal did not exist or gram implementation, the Agency will were corrected by the State or Indian automatically extend the reporting in- Tribe, EPA may rescind its Notice of terval to every 2 years. If the subse- Intent to Withdraw authorization. quent reports demonstrate problems (6) Where EPA finds that deficiencies with implementation, EPA will require in the State or Tribal program exist a return to annual reporting until the that warrant withdrawal, an agree- reports demonstrate successful pro- ment to correct the deficiencies shall gram implementation, at which time be jointly prepared by the State or In- the Agency will extend the reporting dian Tribe and EPA. The agreement interval to every 2 years. shall describe the deficiencies found in The report shall include the fol- the program, specify the steps the lowing information: State or Indian Tribe has taken or will (1) Any significant changes in the take to remedy the deficiencies, and content or administration of the State establish a schedule, no longer than 180 or Tribal program implemented since days, for each remedial action to be the previous reporting period; and initiated.

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(7) If the State or Indian Tribe does (ii) Procedures for the re-accredita- not respond within 60 days of issuance tion of training programs. of the Notice of Intent to Withdraw or (iii) Procedures for the oversight of an agreement is not reached within 180 training programs. days after EPA determines that a (iv) Procedures for the suspension, State or Indian Tribe is not in compli- revocation, or modification of training ance with the Federal program, the program accreditations; or Agency shall issue an order with- (2) Procedures or regulations, for the drawing the State’s or Indian Tribe’s purposes of certification, for the ac- authorization. ceptance of training offered by an ac- (8) By the date of such order, the Ad- credited training provider in a State or ministrator will establish and enforce Tribe authorized by EPA. the provisions of subpart E or subpart (c) Certification of individuals. The L of this part, or both, as the Federal State or Indian Tribe must have re- program for that State or Indian Coun- quirements for the certification of in- try. dividuals that: [61 FR 45825, Aug. 29, 1996, as amended at 73 (1) Ensure that certified individuals: FR 21767, Apr. 22, 2008] (i) Are trained by an accredited training program; and § 745.325 Lead-based paint activities: (ii) Possess appropriate education or State and Tribal program requirements. experience qualifications for certification. (a) Program elements. To receive au- (2) Establish procedures for re-certifi- thorization from EPA, a State or Trib- cation. al program must contain at least the (3) Require the conduct of lead-based following program elements for lead- paint activities in accordance with based paint activities: work practice standards established by (1) Procedures and requirements for the State or Indian Tribe. the accreditation of lead-based paint (4) Establish procedures for the sus- activities training programs. pension, revocation, or modification of (2) Procedures and requirements for certifications. the certification of individuals engaged in lead-based paint activities. (5) Establish requirements and proce- (3) Work practice standards for the dures for the administration of a third- conduct of lead-based paint activities. party certification exam. (4) Requirements that all lead-based (d) Work practice standards for the con- paint activities be conducted by appro- duct of lead-based paint activities. The priately certified contractors. State or Indian Tribe must have re- (5) Development of the appropriate quirements or standards that ensure infrastructure or government capacity that lead-based paint activities are to effectively carry out a State or Trib- conducted reliably, effectively, and al program. safely. At a minimum the State’s or In- (b) Accreditation of training programs. dian Tribe’s work practice standards The State or Indian Tribe must have for conducting inspections, risk assess- either: ments, and abatements must contain (1) Procedures and requirements for the requirements specified in para- the accreditation of training programs graphs (d)(1), (d)(2), and (d)(3) of this that establish: section. (i) Requirements for the accredita- (1) The work practice standards for tion of training programs, including the inspection for the presence of lead- but not limited to: based paint must require that: (A) Training curriculum require- (i) Inspections are conducted only by ments. individuals certified by the appropriate (B) Training hour requirements. State or Tribal authority to conduct (C) Hands-on training requirements. inspections. (D) Trainee competency and pro- (ii) Inspections are conducted in a ficiency requirements. way that identifies the presence of (E) Requirements for training pro- lead-based paint on painted surfaces gram quality control. within the interior or on the exterior

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of a residential dwelling or child-occu- (i) Abatements are conducted only by pied facility. individuals certified by the appropriate (iii) Inspections are conducted in a State or Tribal authority to conduct or way that uses documented methodolo- supervise abatements. gies that incorporate adequate quality (ii) Abatements permanently elimi- control procedures. nate lead-based paint hazards and are (iv) A report is developed that clearly conducted in a way that does not in- documents the results of the inspec- crease the hazards of lead-based paint tion. to the occupants of the dwelling or (v) Records are retained by the cer- child-occupied facility. tified inspector or the firm. (iii) Abatements include post-abate- (2) The work practice standards for ment lead in dust clearance sampling risk assessment must require that: and conformance with clearance levels (i) Risk assessments are conducted established or adopted by the State or only by individuals certified by the ap- Indian Tribe. propriate State or Tribal authority to (iv) The abatement contractor devel- conduct risk assessments. ops a report that describes areas of the (ii) Risk assessments are conducted residential dwelling or child-occupied in a way that identifies and reports the facility abated and the techniques em- presence of lead-based paint hazards. ployed. (iii) Risk assessments consist of, at (v) The certified abatement con- least: tractor or the firm retains appropriate (A) An assessment, including a visual records. inspection, of the physical characteris- (e) The State or Indian Tribe must tics of the residential dwelling or demonstrate that it has standards for child-occupied facility; identifying lead-based paint hazards (B) Environmental sampling for lead and clearance standards for dust, that in paint, dust, and soil; are at least as protective as the stand- (C) Environmental sampling require- ards in § 745.227 as amended on Feb- ments for lead in paint, dust, and soil ruary 5, 2001. A State or Indian Tribe that allow for comparison to the stand- with such a section 402 program ap- ards for lead-based paint hazards estab- proved before February 5, 2003 shall lished or revised by the State or Indian make this demonstration no later than Tribe pursuant to paragraph (e) of this the first report submitted pursuant to section; and § 745.324(h) on or after February 5, 2003. (D) A determination of the presence A State or Indian Tribe with such a of lead-based paint hazards made by program submitted but not approved comparing the results of visual inspec- before February 5, 2003 may make this tion and environmental sampling to demonstration by amending its appli- the standards for lead-based paint haz- cation or in its first report submitted ards established or revised by the State pursuant to § 745.324(h). A State or In- or Indian Tribe pursuant to paragraph dian Tribe submitting its program on (e) of this section. or after February 5, 2003 shall make (iv) The program elements required this demonstration in its application. in paragraph (d)(2)(iii)(C) and (d)(2)(iii)(D) of this section shall be [61 FR 45825, Aug. 29, 1996, as amended at 66 adopted in accordance with the sched- FR 1240, Jan. 5, 2001] ule for the demonstration required in paragraph (e) of this section. § 745.326 Renovation: State and Tribal (v) The risk assessor develops a re- program requirements. port that clearly presents the results of (a) Program elements. To receive au- the assessment and recommendations thorization from EPA, a State or Trib- for the control or elimination of all al program must contain the following identified hazards. program elements: (vi) The certified risk assessor or the (1) For pre-renovation education pro- firm retains the appropriate records. grams, procedures and requirements (3) The work practice standards for for the distribution of lead hazard in- abatement must require that: formation to owners and occupants of

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target housing and child-occupied fa- facility owners and occupants in that cilities before renovations for com- State or Tribe. pensation. (i) A State or Tribe with a pre-ren- (2) For renovation training, certifi- ovation education program approved cation, accreditation, and work prac- before June 23, 2008, must demonstrate tice standards programs: that it meets the requirements of this (i) Procedures and requirements for section no later than the first report the accreditation of renovation and that it submits pursuant to § 745.324(h) dust sampling technician training pro- on or after April 22, 2009. grams. (ii) A State or Tribe with an applica- (ii) Procedures and requirements for tion for approval of a pre-renovation the certification of renovators and dust education program submitted but not sampling technicians. approved before June 23, 2008, must (iii) Procedures and requirements for demonstrate that it meets the require- the certification of individuals and/or ments of this section either by amend- firms. ing its application or in the first report (iv) Requirements that all renova- that it submits pursuant to § 745.324(h) tions be conducted by appropriately of this part on or after April 22, 2009. certified individuals and/or firms. (iii) A State or Indian Tribe submit- (v) Work practice standards for the ting its application for approval of a conduct of renovations. pre-renovation education program on (3) For all renovation programs, de- or after June 23, 2008, must dem- velopment of the appropriate infra- onstrate in its application that it structure or government capacity to meets the requirements of this section. effectively carry out a State or Tribal (c) Accreditation of training programs. program. To be considered at least as protective (b) Pre-renovation education. To be as the Federal program, the State or considered at least as protective as the Tribal program must meet the require- Federal program, the State or Tribal ments of either paragraph (c)(1) or program must: (c)(2) of this section: (1) Establish clear standards for iden- (1) The State or Tribal program must tifying renovation activities that trig- establish accreditation procedures and ger the information distribution re- requirements, including: quirements. (i) Procedures and requirements for (2) Establish procedures for distrib- the accreditation of training programs, uting the lead hazard information to including, but not limited to: owners and occupants of housing and (A) Training curriculum require- child-occupied facilities prior to ren- ments. ovation activities. (B) Training hour requirements. (3) Require that the information to (C) Hands-on training requirements. be distributed include either the pam- (D) Trainee competency and pro- phlet titled Renovate Right: Important ficiency requirements. Lead Hazard Information for Families, (E) Requirements for training pro- Child Care Providers and Schools, devel- gram quality control. oped by EPA under section 406(a) of (ii) Procedures and requirements for TSCA, or an alternate pamphlet or the re-accreditation of training pro- package of lead hazard information grams. that has been submitted by the State (iii) Procedures for the oversight of or Tribe, reviewed by EPA, and ap- training programs. proved by EPA for that State or Tribe. (iv) Procedures and standards for the Such information must contain renova- suspension, revocation, or modification tion-specific information similar to of training program accreditations; or that in Renovate Right: Important Lead (2) The State or Tribal program must Hazard Information for Families, Child establish procedures and requirements Care Providers and Schools, must meet for the acceptance of renovation train- the content requirements prescribed by ing offered by training providers ac- section 406(a) of TSCA, and must be in credited by EPA or a State or Tribal a format that is readable to the diverse program authorized by EPA under this audience of housing and child-occupied subpart.

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(d) Certification of renovators. To be (3) A State or Tribe submitting its considered at least as protective as the application for approval of a renova- Federal program, the State or Tribal tion program on or after the effective program must: date of the revisions must demonstrate (1) Establish procedures and require- in its application that it meets the re- ments for individual certification that quirements of the new renovation pro- ensure that certified renovators are gram requirements in subparts E and L trained by an accredited training proof this part. gram. [73 FR 21768, Apr. 22, 2008, as amended at 75 (2) Establish procedures and require- FR 24819, May 6, 2010] ments for re-certification. (3) Establish procedures for the sus- § 745.327 State or Indian Tribal lead- pension, revocation, or modification of based paint compliance and en- certifications. forcement programs. (e) Work practice standards for renova- (a) Approval of compliance and enforce- tions. To be considered at least as pro- ment programs. A State or Indian Tribe tective as the Federal program, the seeking authorization of a lead-based State or Tribal program must establish paint program can apply for and re- standards that ensure that renovations ceive either interim or final approval are conducted reliably, effectively, and of the compliance and enforcement safely. At a minimum, the State or program portion of its lead-based paint Tribal program must contain the fol- program. Indian Tribes are not re- lowing requirements: quired to exercise criminal enforce- (1) Renovations must be conducted ment jurisdiction as a condition for only by certified contractors. program authorization. (2) Renovations are conducted using (1) Interim approval. Interim approval lead-safe work practices that are at of the compliance and enforcement least as protective to occupants as the program portion of the State or Tribal requirements in § 745.85. lead-based paint program may be (3) Certified contractors must retain granted by EPA only once, and subject appropriate records. to a specific expiration date. (f) Revisions to renovation program re- (i) To be considered adequate for pur- quirements. When EPA publishes in the poses of obtaining interim approval for FEDERAL REGISTER revisions to the the compliance and enforcement pro- renovation program requirements con- gram portion of a State or Tribal lead- tained in subparts E and L of this part: based paint program, a State or Indian (1) A State or Tribe with a renova- Tribe must, in its application described tion program approved before the effec- at § 745.324(a): tive date of the revisions to the renova- (A) Demonstrate it has the legal au- tion program requirements in subparts thority and ability to immediately im- E and L of this part must demonstrate plement the elements in paragraph (b) that it meets the requirements of this of this section. This demonstration section no later than the first report shall include a statement that the that it submits pursuant to § 745.324(h) State or Indian Tribe, during the in- but no later than 2 years after the ef- terim approval period, shall carry out a fective date of the revisions. level of compliance monitoring and en- (2) A State or Tribe with an applica- forcement necessary to ensure that the tion for approval of a renovation pro- State or Indian Tribe addresses any gram submitted but not approved be- significant risks posed by noncompli- fore the effective date of the revisions ance with lead-based paint activity re- to the renovation program require- quirements. ments in subparts E and L of this part (B) Present a plan with time frames must demonstrate that it meets the re- identified for implementing in the field quirements of this section either by each element in paragraph (c) of this amending its application or in the first section. All elements of paragraph (c) report that it submits pursuant to of this section must be fully imple- § 745.324(h) of this part but no later mented no later than 3 years from the than 2 years after the effective date of date of EPA’s interim approval of the the revisions. compliance and enforcement program

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portion of a State or Tribal lead-based plement the elements in paragraphs (b) paint program. A statement of re- and (c) of this section. sources must be included in the State (B) Submit a statement of resources or Tribal plan which identifies what re- which identifies what resources the sources the State or Indian Tribe in- State or Indian Tribe intends to devote tends to devote to the administration to the administration of its lead-based of its lead-based paint compliance and paint compliance and enforcement pro- enforcement program. gram. (C) Agree to submit to EPA the Sum- (C) Agree to submit to EPA the Sum- mary on Progress and Performance of mary on Progress and Performance of lead-based paint compliance and en- lead-based paint compliance and enforcement activities as described at forcement activities as described at paragraph (d) of this section. paragraph (d) of this section. (ii) Any interim approval granted by (ii) For States or Indian Tribes which EPA for the compliance and enforce- previously received interim approval as ment program portion of a State or described in paragraph (a)(1) of this Tribal lead-based paint program will section, in order for the State or Tribal expire no later than 3 years from the compliance and enforcement program date of EPA’s interim approval. One to be considered adequate for final ap- hundred and eighty days prior to this proval through a separate application expiration date, a State or Indian Tribe addressing only the compliance and en- shall apply to EPA for final approval of forcement program portion of a State the compliance and enforcement pro- or Tribal lead-based paint program, a gram portion of a State or Tribal lead- State or Indian Tribe must, in its ap- based paint program. Final approval plication: shall be given to any State or Indian Tribe which has in place all of the ele- (A) Demonstrate that it has the legal ments of paragraphs (b), (c), and (d) of authority and ability to immediately this section. If a State or Indian Tribe implement the elements in paragraphs does not receive final approval for the (b) and (c) of this section. compliance and enforcement program (B) Submit a statement which identi- portion of a State or Tribal lead-based fies the resources the State or Indian paint program by the date 3 years after Tribe intends to devote to the adminis- the date of EPA’s interim approval, the tration of its lead-based paint compli- Administrator shall, by such date, ini- ance and enforcement program. tiate the process to withdraw the State (C) Agree to submit to EPA the Sum- or Indian Tribe’s authorization pursu- mary on Progress and Performance of ant to § 745.324(i). lead-based paint compliance and en- (2) Final approval. Final approval of forcement activities as described at the compliance and enforcement pro- paragraph (d) of this section. gram portion of a State or Tribal lead- (D) To the extent not previously sub- based paint program can be granted by mitted through the application de- EPA either through the application scribed at § 745.324(a), submit copies of process described at § 745.324(a), or, for all applicable State or Tribal statutes, States or Indian Tribes which pre- regulations, standards, and other mate- viously received interim approval as rial that provide the State or Indian described in paragraph (a)(1) of this Tribe with authority to administer and section, through a separate application enforce the lead-based paint compli- addressing only the compliance and en- ance and enforcement program, and forcement program portion of a State copies of the policies, certifications, or Tribal lead-based paint program. plans, reports, and any other docu- (i) For the compliance and enforce- ments that demonstrate that the pro- ment program to be considered ade- gram meets the requirements estab- quate for final approval through the lished in paragraphs (b) and (c) of this application described at § 745.324(a), a section. State or Indian Tribe must, in its ap- (b) Standards, regulations, and author- plication: ity. The standards, regulations, and au- (A) Demonstrate it has the legal authority described in paragraphs (b)(1) thority and ability to immediately im- through (b)(4) of this section are part

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of the required elements for the com- (iii) Authority to apply criminal pliance and enforcement portion of a sanctions or other criminal authority State or Tribal lead-based paint pro- using existing State or Tribal laws, as gram. applicable. (1) Lead-based paint activities and re- (4) Adequate resources. An application quirements. State or Tribal lead-based must include a statement that identi- paint compliance and enforcement pro- fies the resources that will be devoted grams will be considered adequate if by the State or Indian Tribe to the ad- the State or Indian Tribe dem- ministration of the State or Tribal onstrates, in its application at lead-based paint compliance and en- § 745.324(a), that it has established a forcement program. This statement lead-based paint program containing must address fiscal and personnel re- the following requirements: sources that will be devoted to the pro- (i) Accreditation of training program. grams as described at § 745.325(b). (c) Performance elements. The perform- (ii) Certification of individuals en- ance elements described in paragraphs gaged in lead-based paint activities as (c)(1) through (c)(7) of this section are described at § 745.325(c). part of the required elements for the (iii) Standards for the conduct of compliance and enforcement program lead-based paint activities as described portion of a State or Tribal lead-based at § 745.325(d); and, as appropriate, paint program. (iv) Requirements that regulate the (1) Training. A State or Tribal lead- conduct of renovation activities as de- based paint compliance and enforce- scribed at § 745.326. ment program must implement a proc- (2) Authority to enter. State or Tribal ess for training enforcement and in- officials must be able to enter, through spection personnel and ensure that en- consent, warrant, or other authority, forcement personnel and inspectors are premises or facilities where lead-based well trained. Enforcement personnel paint activities violations may occur for purposes of conducting inspections. must understand case development procedures and the maintenance of proper (i) State or Tribal officials must be able to enter premises or facilities case files. Inspectors must successfully where those engaged in training for demonstrate knowledge of the require- lead-based paint activities conduct ments of the particular discipline (e.g., business. abatement supervisor, and/or abate- (ii) For the purposes of enforcing a ment worker, and/or lead-based paint renovation program, State or Tribal of- inspector, and/or risk assessor, and/or ficials must be able to enter a firm’s project designer) for which they have place of business or work site. compliance monitoring and enforce- (iii) State or Tribal officials must ment responsibilities. Inspectors must have authority to take samples and re- also be trained in violation discovery, view records as part of the lead-based methods of obtaining consent, evidence paint activities inspection process. gathering, preservation of evidence and (3) Flexible remedies. A State or Tribal chain-of-custody, and sampling proce- lead-based paint compliance and en- dures. A State or Tribal lead-based forcement program must provide for a paint compliance and enforcement pro- diverse and flexible array of enforce- gram must also implement a process ment remedies. At a minimum, the for the continuing education of en- remedies that must be reflected in an forcement and inspection personnel. enforcement response policy must in- (2) Compliance assistance. A State or clude the following: Tribal lead-based paint compliance and (i) Warning letters, Notices of Non- enforcement program must provide compliance, Notices of Violation, or compliance assistance to the public the equivalent; and the regulated community to facili- (ii) Administrative or civil actions, tate awareness and understanding of including penalty authority (e.g., ac- and compliance with State or Tribal creditation or certification suspension, requirements governing the conduct of revocation, or modification); and lead-based paint activities. The type

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and nature of this assistance can be de- paint compliance and enforcement pro- fined by the State or Indian Tribe to gram must demonstrate, in its applica- achieve this goal. tion for approval, that it is in a posi- (3) Sampling techniques. A State or tion to implement a compliance moni- Tribal lead-based paint compliance and toring and enforcement program. Such enforcement program must have the a compliance monitoring and enforce- technological capability to ensure ment program must ensure correction compliance with the lead-based paint of violations, and encompass either program requirements. A State or planned and/or responsive lead-based Tribal application for approval of a paint compliance inspections and de- lead-based paint program must show velopment/issuance of State or Tribal that the State or Indian Tribe is tech- enforcement responses which are ap- nologically capable of conducting a propriate to the violations. lead-based paint compliance and en- (d) Summary on Progress and Perform- forcement program. The State or Trib- ance. The Summary on Progress and al program must have access to the fa- Performance described below is part of cilities and equipment necessary to the required elements for the compli- perform sampling and laboratory anal- ance and enforcement program portion ysis as needed. This laboratory facility of a State or Tribal lead-based paint must be a recognized laboratory as de- program. A State or Tribal lead-based fined at § 745.223, or the State or Tribal paint compliance and enforcement pro- program must implement a quality as- gram must submit to the appropriate surance program that ensures appro- EPA Regional Administrator a report priate quality of laboratory personnel which summarizes the results of imple- and protects the integrity of analytical menting the State or Tribal lead-based data. (4) Tracking tips and complaints. A paint compliance and enforcement pro- State or Tribal lead-based paint com- gram, including a summary of the pliance and enforcement program must scope of the regulated community demonstrate the ability to process and within the State or Indian Tribe (which react to tips and complaints or other would include the number of individ- information indicating a violation. uals and firms certified in lead-based (5) Targeting inspections. A State or paint activities and the number of Tribal lead-based paint compliance and training programs accredited), the in- enforcement program must dem- spections conducted, enforcement ac- onstrate the ability to target inspections taken, compliance assistance pro- tions to ensure compliance with the vided, and the level of resources com- lead-based paint program require- mitted by the State or Indian Tribe to ments. Such targeting must include a these activities. The report shall be method for obtaining and using notifi- submitted according to the require- cations of commencement of abatements at § 745.324(h). ment activities. (e) Memorandum of Agreement. An In- (6) Follow up to inspection reports. A dian Tribe that obtains program ap- State or Tribal lead-based paint com- proval must establish a Memorandum pliance and enforcement program must of Agreement with the Regional Ad- demonstrate the ability to reasonably, ministrator. The Memorandum of and in a timely manner, process and Agreement shall be executed by the In- follow-up on inspection reports and dian Tribe’s counterpart to the State other information generated through Director (e.g., the Director of Tribal enforcement-related activities associ- Environmental Office, Program or ated with a lead-based paint program. Agency). The Memorandum of Agree- The State or Tribal program must be ment must include provisions for the in a position to ensure correction of timely and appropriate referral to the violations and, as appropriate, effec- Regional Administrator for those tively develop and issue enforcement criminal enforcement matters where remedies/responses to follow up on the that Indian Tribe does not have the au- identification of violations. thority (e.g., those addressing criminal (7) Compliance monitoring and enforce- violations by non-Indians or violations ment. A State or Tribal lead-based meriting penalties over $5,000). The

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Agreement must also identify any en- are prohibited and requires that warn- forcement agreements that may exist ings and instructions accompany the between the Indian Tribe and any substance when distributed in com- State. merce. (f) Electronic reporting under State or (a) Chemical substance subject to this Indian Tribe programs. States and tribes section. The following chemical sub- that choose to receive electronic docu- stance, referred to by its ments under the authorized state or In- premanufacture notice number and ge- dian tribe lead-based paint program, neric chemical name, is subject to this must ensure that the requirements of section: P-84–529, mixed mono and 40 CFR part 3—(Electronic reporting) diamides of an organic acid. are satisfied in their lead-based paint (b) Definitions. Definitions in section program. 3 of the Act, 15 U.S.C. 2602, apply to [61 FR 45825, Aug. 29, 1996, as amended at 70 this section unless otherwise specified FR 59889, Oct. 13, 2005; 73 FR 21769, Apr. 22, in this paragraph. In addition, the fol- 2008] lowing definitions apply: (1) The terms Act, article, chemical § 745.339 Effective date. substance, commerce, importer, impurity, States and Indian Tribes may seek Inventory, manufacturer, person, process, authorization to administer and en- processor, and small quantities solely for force subpart L of this part pursuant to research and development have the same this subpart at any time. States and meaning as in § 720.3 of this chapter. Indian Tribes may seek authorization (2) Metalworking fluid means a liquid to administer and enforce the pre-ren- of any viscosity or color containing in- ovation education provisions of subpart tentionally added water used in metal E of this part pursuant to this subpart machining operations for the purpose at any time. States and Indian Tribes of cooling, lubricating, or rust inhibi- may seek authorization to administer tion. and enforce all of subpart E of this part (3) Nitrosating agent means any sub- pursuant to this subpart effective June stance that has the potential to trans- 23, 2008. fer a nitrosyl group (–NO) to a primary, [73 FR 21769, Apr. 22, 2008] secondary, or tertiary amine to form the corresponding nitrosamine. (4) Process or distribute in commerce PART 747—METALWORKING FLUIDS solely for export means to process or distribute in commerce solely for export Subpart A [Reserved] from the United States under the fol- Subpart B—Specific Use Requirements for lowing restrictions on domestic activ- Certain Chemical Substances ity: (i) Processing must be performed at Sec. sites under the control of the proc- 747.115 Mixed mono and diamides of an or- essor. ganic acid. (ii) Distribution in commerce is lim- 747.195 Triethanolamine salt of a substituted organic acid. ited to purposes of export. 747.200 Triethanolamine salt of (iii) The processor or distributor may tricarboxylic acid. not use the substance except in small quantities solely for research and de- AUTHORITY: 15 U.S.C. 2604 and 2605. velopment. (c) Use limitations. (1) Any person pro- Subpart A [Reserved] ducing a metalworking fluid, or a product which could be used in or as a met- Subpart B—Specific Use Require- alworking fluid, which includes as one ments for Certain Chemical of its components P-84–529, is prohib- Substances ited from adding any nitrosating agent to the metalworking fluid or product. § 747.115 Mixed mono and diamides of (2) Any person using as a metal- an organic acid. working fluid a product containing P- This section identifies activities with 84–529 is prohibited from adding any respect to a chemical substance which nitrosating agent to the product.

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(d) Warnings and instructions. (1) Any than six point type. All required label person who distributes in commerce P- text shall be of sufficient prominence, 84–529 in a metalworking fluid, or in and shall be placed with such conspicu- any form in which it could be used as ousness relative to other label text and a component of a metalworking fluid, graphic material, to insure that the must send to each recipient of P-84–529 warning statement is read and under- and confirm receipt in writing prior to stood by the ordinary individual under the first shipment to that person: customary conditions of purchase and (i) A letter that includes the fol- use. lowing statements: (e) Liability and determining whether a chemical substance is subject to this sec- A substance, identified generically as mixed mono and diamides of an organic acid, tion. (1) If a manufacturer or importer contained in the product (insert distributor’s of a chemical substance which is de- other identifier for product containing P-84–529) scribed by the generic chemical name has been regulated by the Environmental in paragraph (a) of this section makes Protection Agency, at 40 CFR 747.115, as pub- an inquiry under § 710.7(g) of this chap- lished in the FEDERAL REGISTER of Sep- ter or § 720.25(b) of this chapter as to tember 20, 1984. A copy of the regulation is whether the specific substance is on enclosed. The regulation prohibits the addi- the Inventory and EPA informs the tion of any nitrosating agent, including nitrites, to the mixed mono and diamides of manufacturer or importer that the sub- an organic acid, when the substance is or stance is on the Inventory, EPA will could be used in metalworking fluids. The also inform the manufacturer or im- addition of nitrites or other nitrosating porter whether the substance is subject agents to this substance leads to formation to this section. of a substance known to cause cancer in lab- (2) Except for manufacturers and im- oratory animals. The mixed mono and porters of P-84–529, no processor, dis- diamides of an organic acid has been specifi- tributor, or user of P-84–529 will be in cally designed to be used without nitrites. Consult the enclosed regulation for further violation of this section unless that information. person has received a letter specified in paragraph (d)(1) of this section or a (ii) A copy of this § 747.115. container with the label specified in (2)(i) Any person who distributes in paragraph (d)(2) of this section. commerce a metalworking fluid con- (f) Exemptions. A person identified in taining P-84–529 must affix a label to paragraphs (c) and (d) of this section is each container containing the fluid. not subject to the requirements of (ii) The label shall contain a warning those paragraphs if: statement which shall consist only of (1) The person manufactures, im- the following language: ports, processes, distributes in com- WARNING! Do Not Add Nitrites to This merce, or uses the substance only in Metalworking Fluid under Penalty of Fed- small quantities solely for research and eral Law. Addition of nitrites leads to forma- development and in accordance with tion of a substance known to cause cancer. section 5(h)(3) of the Act. This product is designed to be used without (2) The person manufactures, im- nitrites. ports, processes, distributes in com- (iii) The first work of the warning merce, or uses the substance only as an statement shall be capitalized, and the impurity. type size for the first word shall be no (3) The person imports, processes, smaller than six point type for a label distributes in commerce, or uses the five square inches or less in area, ten substance only as part of an article. point type for a label above five but (4) The person processes or distrib- below ten square inches in area, twelve utes the substance in commerce solely point type for a label above ten but for export and, when distributing in below fifteen square inches in area, commerce, lables the substance in ac- fourteen point type for a label above cordance with section 12(a)(1)(B) of the fifteen but below thirty square inches Act. in area, or eighteen point type for a (g) Enforcement. (1) Failure to comply label over thirty square inches in area. with any provision of this section is a The type size of the remainder of the violation of section 15 of the Act [15 warning statement shall be no smaller U.S.C. 2614].

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(2) Failure or refusal to permit access mary, secondary, or tertiary amine to to or copying of records, as required form the corresponding nitrosamine. under section 11 of the Act, is a viola- (4) Process or distribute in commerce tion of section 15 of the Act [15 U.S.C. solely for export means to process or dis- 2614]. tribute in commerce solely for export (3) Failure or refusal to permit entry from the United States under the fol- or inspection, as required under section lowing restrictions on domestic activ- 11 of the Act, is a violation of section ity: 15 of the Act [15 U.S.C. 2614]. (4) Violators may be subject to the (i) Processing must be performed at civil and criminal penalties in section sites under the control of the proc- 16 of the Act [15 U.S.C. 2615] for each essor. violation. (ii) Distribution in commerce is lim- (5) EPA may seek to enjoin the proc- ited to purposes of export. essing, distribution in commerce, or (iii) The processor or distributor may use of a chemical substance in viola- not use the substance except in small tion of this section; act to seize any quantities solely for research and de- chemical substance processed, distrib- velopment. uted in commerce, or used in violation (c) Use limitations. (1) Any person proof this section; or take other actions ducing a metalworking fluid, or a prod- under the authority of sections 7 and 17 uct which could be used in or as a met- of the Act [15 U.S.C. 2605 and 2616]. alworking fluid, which includes as one [49 FR 36855, Sept. 20, 1984] of its components P-84–310, is prohibited from adding any nitrosating agent § 747.195 Triethanolamine salt of a to the metalworking fluid or product. substituted organic acid. (2) A person using as a metalworking This section identifies activities with fluid a product containing P-84–310 is respect to a chemical substance which prohibited from adding any nitrosating are prohibited and requires that warn- agent to the product. ings and instructions accompany the (d) Warnings and instructions. (1) Any substance when distributed in com- person who distributes in commerce P- merce. 84–310 in a metalworking fluid, or in (a) Chemical substance subject to this section. The following chemical sub- any form in which it could be used as stance, referred to by its a component of a metalworking fluid, premanufacture notice number and ge- must send to each recipient of P-84–310 neric chemical name, is subject to this and confirm receipt in writing prior to section: P-84–310, triethanolamine salt the first shipment to that person: of a substituted organic acid. (i) A letter that includes the fol- (b) Definitions. Definitions in section lowing statements: A substance, identi- 3 of the Act, 15 U.S.C. 2602, apply to fied generically as a triethanolamine this section unless otherwise specified salt of a substituted organic acid, con- in this paragraph. In addition, the fol- tained in the product (insert distribu- lowing definitions apply: tor’s trade name or other identifier for (1) The terms Act, article, chemical product containing P-84–310) has been substance, commerce, importer, impurity, regulated by the Environmental Pro- Inventory, manufacturer, person, process, tection Agency, at 40 CFR 747.195, as processor, and small quantities solely for published in the FEDERAL REGISTER of research and development, have the same June 14, 1984. A copy of the regulation meaning as in § 720.3 of this chapter. is enclosed. The regulation prohibits (2) Metalworking fluid means a liquid the addition of any nitrosating agent, of any viscosity or color containing in- including nitrites, to the triethanol- tentionally added water used in metal machining operations for the purpose amine salt of a substituted organic of cooling, lubricating, or rust inhibi- acid, when the substance is or could be tion. used in metalworking fluids. The addi- (3) Nitrosating agent means any sub- tion of nitrites or other nitrosating stance that has the potential to trans- agents to this substance leads to for- fer a nitrosyl group (—NO) to a pri- mation of a substance known to cause

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cancer in laboratory animals. The tri- (2) Except for manufacturers and im- ethanolamine salt of a substituted or- porters of P-84–310, no processor, dis- ganic acid has been specifically de- tributor, or user of P-84–310 will be in signed to be used without nitrites. Con- violation of this section unless that sult the enclosed regulation for further person has received a letter specified in information. paragraph (d)(1) of this section or a (ii) A copy of this § 747.195. container with the label specified in (2)(i) Any person who distributes in paragraph (d)(2) of this section. commerce a metalworking fluid con- (f) Exemptions. A person identified in taining P-84–310 must affix a label to paragraphs (c) and (d) of this section is each container containing the fluid. not subject to the requirements of (ii) The label shall contain a warning those paragraphs if: statement which shall consist only of (1) The person manufactures, im- the following language: ports, processes, distributes in com- WARNING! Do Not Add Nitrites to This merce, or uses the substance only in Metalworking Fluid under Penalty of Fed- small quantities solely for research and eral Law. Addition of nitrites leads to forma- development and in accordance with tion of a substance known to cause cancer. section 5(h)(3) of the Act. This product is designed to be used without (2) The person manufactures, im- nitrites. ports, processes, distributes in com- (iii) The first word of the warning merce, or uses the substance only as an statement shall be capitalized, and the impurity. type size for the first word shall be no (3) The person imports, processes, smaller than six point type for a label distributes in commerce, or uses the five square inches or less in area, ten substance only as part of an article. point type for a label above five but (4) The person processes or distrib- below ten square inches in area, twelve utes the substance in commerce solely point type for a label above ten but for export, and when distributing in below fifteen square inches in area, commerce, labels the substance in ac- fourteen point type for a label above cordance with section 12(a)(1)(B) of the fifteen but below thirty square inches Act. in area, or eighteen point type for a (g) Enforcement. (1) Failure to comply label over thirty square inches in area. with any provision of this section is a The type size of the remainder of the violation of section 15 of the Act (15 warning statement shall be no smaller U.S.C. 2614). than six point type. All required label (2) Failure or refusal to permit access text shall be of sufficient prominence, to or copying of records, as required and shall be placed with such conspicu- under section 11 of the Act, is a viola- ousness relative to other label text and tion of section 15 of the Act (15 U.S.C. graphic material, to insure that the 2614). warning statement is read and under- (3) Failure or refusal to permit entry stood by the ordinary individual under or inspection, as required under section customary conditions of purchase and 11 of the Act, is a violation of section use. 15 of the Act (15 U.S.C. 2614). (e) Liability and determining whether a chemical substance is subject to this sec- [49 FR 24668, June 14, 1984] tion. (1) If a manufacturer or importer of a chemical substance which is de- § 747.200 Triethanolamine salt of scribed by the generic chemical name tricarboxylic acid. in paragraph (a) of this section makes This section identifies activities with an inquiry under § 710.7(g) of this chap- respect to two chemical substances ter or § 720.25(b) of this chapter as to which are prohibited and requires that whether the specific substance is on warnings and instructions accompany the Inventory and EPA informs the the substances when distributed in manufacturer or importer that the sub- commerce. stance is on the Inventory, EPA will (a) Chemical substances subject to this also inform the manufacturer or im- section. The following chemical sub- porter whether the substance is subject stances, referred to by their to this section. premanufacture notice numbers and

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generic chemical names, are subject to tion of any nitrosating agent, including this section: nitrites, to the triethanolamine salt of tricarboxylic acid, when the substance is or P-83–1005, triethanolamine salt of could be used in metalworking fluids. The tricarboxylic acid; and addition of nitrites or other nitrosating P-83–1062, tricarboxylic acid. agents to this substance leads to formation (b) Definitions. Definitions in section of a substance known to cause cancer in lab- 3 of the Act, 15 U.S.C. 2602, apply to oratory animals. The triethanolamine salt of the tricarboxylic acid, has been specifically this section unless otherwise specified designed to be used without nitrites. Consult in this paragraph. In addition, the fol- the enclosed regulation for further informa- lowing definitions apply: tion. (1) The terms Act, article, byproducts, chemical substance, commerce, imported, (ii) A copy of this rule. impurity, Inventory, manufacture or im- (2) Any person who distributes in port for commercial purposes, manufac- commerce a metalworking fluid con- ture solely for export, manufacturer, new taining P-83–1005 must affix to each chemical substance, person, process, proc- container containing the fluid a label essor, and small quantities solely for re- that includes, in letters no smaller search and development have the same than ten point type, the following meaning as in § 720.3 of this chapter. statement: (2) Metalworking fluid means a liquid WARNING! Do Not Add Nitrites to This of any viscosity or color containing in- Metalworking Fluid under Penalty of Fed- tentionally added water used in metal eral Law. Addition of nitrite leads to forma- machining operations for the purpose tion of a substance known to cause cancer. of cooling or lubricating. This product is designed to be used without (3) Nitrosating agent means any sub- nitrites. stance that has the potential to trans- (3) Any person who distributes in fer a nitrosyl group (—NO) to a sec- commerce P-83–1062 in any form in ondary or tertiary amine to form the which it could be combined with water corresponding nitrosamine. and triethanolamine to produce P-83– (c) Use limitations. (1) Any person pro- 1005 must send to each recipient of P- ducing a metalworking fluid, or a prod- 83–1062, and confirm receipt prior to uct which could be used in or as a met- the first shipment to that person: alworking fluid, which includes as one (i) A letter that includes the fol- of its components P-83–1005 is prohib- lowing statements: ited from adding any nitrosating agent to the metalworking fluid or product. A substance, identified generically as (2) Any person using as metalworking tricarboxylic acid, contained in the product fluid a product containing P-83–1005 is (insert distributor’s trade name or other identi- prohibited from adding any nitrosating fier for product containing P-83–1062) has been agent to the product. regulated by the Environmental Protection (d) Warnings and instructions. (1) Any Agency (40 CFR 747.200 published in the FED- ERAL REGISTER of January 23, 1984. A copy of person who distributes in commerce P- the regulation is enclosed. Combining 83–1005 in a metalworking fluid, or in tricarboxylic acid with water and the tri- any form in which it could be used as ethanolamine produces a substance, identi- a component of a metalworking fluid, fied generically as the triethanolamine salt must sent to each recipient of P-83–1005 of the tricarboxylic acid. The regulation pro- and confirm receipt prior to the first hibits the addition of nitrosating agents, in- shipment to that person: cluding nitrites, to the triethanolamine salt (i) A letter that includes the fol- of tricarboxylic acid, when that substance is or could be used in metalworking fluids. The lowing statements: addition of nitrites or other nitrosating A substance, identified generically as tri- agents to that substance leads to formation ethanolamine salt, of tricarboxylic acid, con- of a substance known to cause cancer in lab- tained in the product (insert distributor’s trade oratory animals. Consult the enclosed regu- name or other identifier for product containing lation for further information. P-83–1005) has been regulated by the Environ- (ii) A copy of this rule. mental Protection Agency, at 40 CFR 747.200, as published in the FEDERAL REGISTER of (e) Liability and determining whether a January 23, 1984. A copy of the regulation is chemical substance is subject to this sec- enclosed. The regulation prohibits the addition. (1) If a manufacturer or importer

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of a chemical substance which is de- 16 of the Act (15 U.S.C 2615) for each scribed by one of the generic names in violation. paragraph (a) of this section makes an (5) EPA may seek to enjoin the proc- inquiry under § 710.7(g) of this chapter essing, distribution in commerce, or or § 720.25(b) of this chapter as to use of a chemical substance in viola- whether the specific substance is on tion of this section, act to seize any the Inventory and EPA informs the chemical substance, processed, distrib- manufacturer or importer that the sub- uted in commerce, or used in violation stance is on the Inventory, EPA will of this section or take other actions also inform the manufacturer or im- under the authority of section 7 or 17 of porter whether the substance is subject the Act (15 U.S.C. 2605 or 2616). to this section. [49 FR 2772, Jan. 23, 1984] (2) Except for manufacturers and importers of P-83–1005 and P-83–1062, no PART 749—WATER TREATMENT processor, distributor, or user of P-83– CHEMICALS 1005 or P-83–1062 will be in violation of this section unless that person has re- Subparts A–C [Reserved] ceived a letter specified in paragraph (d)(1) or (3) of this section or a con- Subpart D—Air Conditioning and Cooling tainer with the label specified in para- Systems graph (d)(2) of this section. (f) Exemptions and exclusions. The Sec. 749.68 Hexavalent chromium-based water chemical substances identified in para- treatment chemicals in cooling systems. graph (a) of this section are not subject to the requirements of paragraphs (c) AUTHORITY: 15 U.S.C. 2605 and 2607. and (d) of this section, if: (1) The substance is manufactured, Subparts A–C [Reserved] imported, processed, distributed in commerce, and used only in small Subpart D—Air Conditioning and quantities solely for research and de- Cooling Systems velopment, and if the substance is manufactured, imported, processed, § 749.68 Hexavalent chromium-based distributed in commerce, and used in water treatment chemicals in cool- accordance with section 5(h)(3) of the ing systems. Act. (a) Chemicals subject to this section. (2) The substance is manufactured, Hexavalent chromium-based water imported, processed, distributed in treatment chemicals that contain commerce, or used only as an impurity. hexavalent chromium, usually in the (3) The substance is imported, proc- form of sodium dichromate (CAS No. essed, distributed in commerce, or used 10588–01–9), are subject to this section. only as part of an article. Other examples of hexavalent chromium compounds that can be used to (4) The substance is manufactured treat water are: Chromic acid (CAS No. solely for export. 7738–94–5), chromium trioxide (CAS No. (g) Enforcement. (1) Failure to comply 1333–83–0), dichromic acid (CAS with any provision of this section is a No.13530–68–2), potassium chromate violation of section 15 of the Act (15 (CAS No. 7789–00–6), potassium dichro- U.S.C. 2614). mate (CAS No. 7778–50–9), sodium chro- (2) Failure or refusal to permit access mate (CAS No. 7775–11–3), zinc chro- to or copying of records, as required mate (CAS No. 13530–65–9), zinc chro- under section 11 of the Act, is a viola- mate hydroxide (CAS No. 153936–94–6), tion of a section 15 of the Act (15 U.S.C. zinc dichromate (CAS No. 14018–95–2), 2614). and zinc potassium chromate (CAS No. (3) Failure or refusal to permit entry 11103–86–9). or inspection, as required under section (b) Purpose. The purpose of this sec- 11 of the Act, is a violation of section tion is to impose certain requirements 15 of the Act (15 U.S.C. 2614). on activities involving hexavalent (4) Violators may be subject to the chromium-based water treatment civil and criminal penalties in section chemicals to prevent unreasonable

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risks associated with human exposure containing hexavalent chromium to air emissions of hexavalent chro- which can be used to treat water, ei- mium from comfort cooling towers. ther alone or in combination with (c) Applicability. This section is appli- other chemicals, where the mixture cable to use of hexavalent chromium- can be used to treat water. based water treatment chemicals in (12) Industrial cooling tower means any comfort cooling towers and to distribu- cooling tower used to remove heat tion in commerce of hexavalent chro- from industrial processes, chemical re- mium-based water treatment chemi- actions, or plants producing electrical cals for use in cooling systems. power. (d) Definitions. Definitions in section (13) Label means any written, printed, 3 of the Toxic Substances Control Act, or graphic material displayed on or af- 15 U.S.C. 2602, apply to this section un- fixed to containers of hexavalent chro- less otherwise specified in this para- mium-based water treatment chemi- graph. In addition, the following defini- cals that are to be used in cooling sys- tions apply: tems. (1) Act means the Toxic Substances (14) Person means any natural person, Control Act, 15 U.S.C. 2601 et seq. firm, company, corporation, joint ven- (2) Chilled water loop means any ture, partnership, sole proprietorship, closed cooling water system that trans- association, or any other business enti- fers heat from air handling units or re- ty; any State or political subdivision frigeration equipment to a refrigera- thereof; any municipality; any inter- tion machine, or chiller. state body; and any department, agen- (3) Closed cooling water system means cy, or instrumentality of the Federal any configuration of equipment in Government. which heat is transferred by circu- lating water that is contained within (15) Shipment means the act or proc- the equipment and not discharged to ess of shipping goods by any form of the air; chilled water loops are in- conveyance. cluded. (16) Water treatment chemicals means (4) Comfort cooling towers means cool- any combination of chemical sub- ing towers that are dedicated stances used to treat water in cooling exlusively to and are an integral part systems and can include corrosion in- of heating, ventilation, and air condi- hibitors, antiscalants, dispersants, and tioning or refrigeration systems. any other chemical substances except (5) Container means any bag, barrel, biocides. bottle, box, can, cylinder, drum, or the (e) Prohibition of distribution in com- like that holds hexavalent chromium- merce and commercial use. (1) All persons based water treatment chemicals for are prohibited from distributing in use in cooling systems. commerce hexavalent chromium-based (6) Cooling tower means an open water water treatment chemicals for use in recirculating device that uses fans or comfort cooling towers. natural draft to draw or force ambient (2) All persons are prohibited from air through the device to cool warm commercial use of hexavalent chro- water by direct contact. mium-based water treatment chemi- (7) Cooling system means any cooling cals in comfort cooling towers. tower or closed cooling water system. (3) Distribution in commerce of (8) Distributor means any person who hexavalent chromium-based water distributes in commerce water treat- treatment chemicals for use in, and ment chemicals for use in cooling sys- commercial use of hexavalent chro- tems. mium-based water treatment chemi- (9) EPA means the Environmental cals in, industrial cooling towers and Protection Agency. closed cooling water systems are not (10) Hexavalent chromium means the prohibited. oxidation state of chromium with an (f) Effective dates. (1) The prohibition oxidation number of +6; a coordination described in paragraph (e)(1) of this number of 4 and tetrahedral geometry. section against distributing in com- (11) Hexavalent chromium-based water merce hexavalent chromium-based treatment chemicals means any chemical water treatment chemicals for use in

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comfort cooling towers is effective tem owners/operators to whom the February 20, 1990. chemicals were shipped. (2) The prohibition described in para- (ii) The chemicals included in the graph (e)(2) of this section against shipment, the amount of each chemical using hexavalent chromium-based shipped, and the location(s) at which water treatment chemicals in comfort the chemicals will be used. cooling towers is effective May 18, 1990. (2) The information described in (g) Labeling. (1) Each person who dis- paragraph (h)(1) of this section shall be tributes in commerce hexavalent chro- retained for 2 years from the date of mium-based water treatment chemi- shipment. cals for use in cooling systems after (i) Reporting. (1) Each person who dis- February 20, 1990, shall affix a label or tributes in commerce any hexavalent keep affixed an existing label in ac- chromium-based water treatment cordance with this paragraph, to each chemicals for use in cooling systems container of the chemicals. The label shall report to the Regional Adminis- shall consist of the following language: trator of the EPA Region in which the distibutor headquarters is located. The WARNING: This product contains report shall be postmarked not later hexavalent chromium. Inhalation of than February 20, 1990, or 30 days after hexavalent chromium air emissions in- the person first begins the distribution creases the risk of lung cancer. Federal Law in commerce of hexavalent chromium- prohibits use of this substance in comfort cooling towers, which are towers that are based water treatment chemicals, open water recirculation devices and that whichever is later, and shall include: are dedicated exclusively to, and are an inte- (i) For the headquarters, the dis- gral part of, heating, ventilation, and air tributor name, address, telephone num- conditioning or refrigeration systems. ber, and the name of a contact. (ii) For the shipment offices through (2) The first word of the warning which hexavalent chromium-based statement shall be capitalized, and the water treatment chemicals are sold for type size for the first word shall be no use in cooling systems, the distributor smaller than 10-point type for a label name, address, telephone number, and less than or equal to 10 square inches the name of a contact. in area, 12-point type for a label above (2) The report identified in paragraph 10 but less than or equal to 15 square (i)(1) of this section shall be updated as inches in area, 14-point type for a label changes occur in the distributor head- above 15 but less than or equal to 30 quarters or shipment office informa- square inches in area, or 18-point type tion. The updated report shall be sub- for a label above 30 square inches in mitted to the Regional Administrator area. The type size of the remainder of and postmarked no later than 10 cal- the warning statement shall be no endar days after the change occurs. smaller than 6-point type. All required (3) A person may assert a claim of label text shall be in English and of confidentiality for any information sufficient prominence and shall be submitted to EPA in connection with placed with such conspicuousness, rel- this rule. Any claim of confidentiality ative to other label text and graphic must accompany the information when material, to ensure that the warning submitted to EPA. Persons claiming statement is read and understood by information as confidential should do the ordinary individual under cus- so by circling, bracketing, or under- tomary conditions of purchase and use. lining it and marking it with ‘‘CON- (h) Recordkeeping. (1) Each person FIDENTIAL.’’ EPA will disclose infor- who distributes in commerce any mation subject to a claim of confiden- hexavalent chromium-based water tiality only to the extent permitted by treatment chemicals for use in cooling section 14 of TSCA and 40 CFR part 2, systems after February 20, 1990, shall subpart B. If a person does not assert a retain in one location at the head- claim of confidentiality for informa- quarters of the distributor documentation at the time it is submitted to tion showing: EPA, EPA may make the information (i) The name, address, contact, and public without further notice to that telephone number of the cooling sys- person.

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(j) Enforcement. (1) Failure to comply 750.21 Final rule. with any provision of this section is a violation of section 15 of the Act (15 Subpart C—Interim Procedural Rules for U.S.C. 2614). Processing and Distribution in Com- (2) Failure or refusal to establish and merce Exemptions maintain records or to permit access to 750.30 Applicability. or copying of records, as required by 750.31 Filing of petitions for exemption. the Act, is a violation of section 15 of 750.32 Consolidation of rulemaking. the Act (15 U.S.C. 2614). 750.33 Notice of proposed rulemaking. (3) Failure or refusal to permit entry 750.34 Record. 750.35 Public comments. or inspection as required by section 11 750.36 Confidentiality. of the Act (15 U.S.C. 2610) is a violation 750.37 Subpoenas. of section 15 of the Act (15 U.S.C. 2614). 750.38 Participation in informal hearing. (4) Violators may be subject to the 750.39 Conduct of informal hearing. civil and criminal penalties in section 750.40 Cross-examination. 16 of the Act (15 U.S.C. 2615) for each 750.41 Final rule. violation. AUTHORITY: 15 U.S.C. 2605. (k) Inspections. EPA will conduct inspections under section 11 of the Act Subpart A—Procedures for Rule- (15 U.S.C. 2610) to ensure compliance making Under Section 6 of the with this section. Toxic Substances Control Act [55 FR 240, Jan. 3, 1990, as amended at 59 FR 42773, Aug. 19, 1994] SOURCE: 42 FR 61259, Dec. 2, 1977, unless otherwise noted. PART 750—PROCEDURES FOR RULE- MAKING UNDER SECTION 6 OF § 750.1 Applicability. THE TOXIC SUBSTANCES CON- This part applies to all rulemakings TROL ACT under authority of section 6 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2605. Subpart A—Procedures for Rulemaking Under Section 6 of the Toxic Sub- § 750.2 Notice of proposed rulemaking. stances Control Act (a) Each rulemaking becomes subject Sec. to this part with the publication of a 750.1 Applicability. Notice of Proposed Rulemaking in the 750.2 Notice of proposed rulemaking. FEDERAL REGISTER. A proceeding under 750.3 Record. section 6 of the Toxic Substances Con- 750.4 Public comments. trol Act may begin, as appropriate, 750.5 Subpoenas. with the publication in the FEDERAL 750.6 Participation in informal hearing. REGISTER of a Notice of Proposed Rule- 750.7 Conduct of legislative hearing. making, an Advance Notice of Pro- 750.8 Cross-examination. posed Rulemaking, or notice of other 750.9 Final rule. action, such as a formal regulatory in- APPENDIX A TO SUBPART A vestigation designed to lead to issuance of rules within a reasonable Subpart B—Interim Procedural Rules for time. Manufacturing Exemptions (b) Each such notice shall contain: (1) A draft finding that there is a rea- 750.10 Applicability. 750.11 Filing of petitions for exemption. sonable basis to conclude that the 750.12 Consolidation of rulemakings. manufacture, processing, distribution 750.13 Notice of proposed rulemaking. in commerce, use or disposal of the 750.14 Record. chemical substance(s) or mixture(s) at 750.15 Public comments. issue, or any combination of such ac- 750.16 Confidentiality. tivities, presents or will present an un- 750.17 Subpoenas. reasonable risk of injury to health or 750.18 Participation in informal hearing. the environment. 750.19 Conduct of informal hearing. (2) A Notice of Proposed Rulemaking 750.20 Cross-examination. stating with particularity the reasons

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for the proposed rule together with a (or laws) to protect against risk of in- statement why the proposed rule pro- jury. tects adequately against the risk(s) in- Two or more or all of the statements volved using the least burdensome re- required above may be combined in the quirements authorized by TSCA. same narrative for efficiency of expo- (3) Either the draft text of the pro- sition as long as each of the required posed rule (which may include alter- points is discussed. Any statement re- native approaches among which a final quired by this paragraph may reference choice has not yet been made) or a de- other documents which are not pub- scription of the approaches and provi- lished in the FEDERAL REGISTER. All sions being considered for inclusion in such referenced documents shall be in- the rule, or some combination of the cluded in the rulemaking record. Ei- above. ther the statements required by this (4) Except for rules published under paragraph or the documents they ref- authority of section 6(e), a draft state- erence shall contain a discussion of the ment with respect to: factual, analytical, policy and legal (i) The effects of the substance(s) or considerations behind the agency deci- mixture(s) at issue on health and the sion to issue the proposed rule in the magnitude of the exposure of human form chosen. A brief summary of these beings to such substance(s) or mix- considerations shall be included in the ture(s); preamble in any case. All factual mate- (ii) The effects of the substace(s) or rials and each analytical methodology mixture(s) at issue on the environment seriously considered shall be fully dis- and the magnitude of the exposure of closed. Significant areas of uncertainty the environment to such substance(s) known to the Agency under each head- or mixture(s). ing shall be identified, and the manner (iii) The benefits of the substance(s) in which the Agency intends to deal or mixture(s) at issue for various uses with them shall be specified. and the availability of substitutes for (c) In addition to the material re- such uses; and quired under paragraph (b) of this sec- (iv) The reasonably ascertainable tion, each notice of proposed rule- economic consequences of the rule, making shall contain: after consideration of the effect on the (1) A statement of the time and place national economy, small business, at which the informal hearing required technological innovation, the environ- by section 6(c)(2)(C) of TSCA shall ment, and public health. begin, or, to the extent these are not (v) Major impacts of alternatives to specified, a statement that they will be the proposed rule shall also be ana- specified later in a separate FEDERAL lyzed. REGISTER notice Provided, That FED- (5) In cases where the administrator, ERAL REGISTER notice of the date and in his or her discretion, determines city at which any informal hearing that a risk of injury to health or the shall begin shall be given at least 30 environment could be eliminated or re- days in advance; duced to a sufficient extent by actions (2) A statement identifying the place taken under a Federal law (or laws) at which the official record of the rule- other than TSCA administered in making is located, the hours during whole or in part by the Administrator, which it will be open for public inspec- a finding that it is in the public inter- tion, the documents contained in it as est to proceed against such risk under of the date the notice of proposed rule- TSCA. Any such finding shall be ac- making was issued, and a statement of companied by a brief statement dis- the approximate times at which addi- cussing: tional materials such as public com- (i) All relevant aspects of the risk; ments, hearing transcripts, and agency (ii) A comparison of the estimated studies in progress will be added to the costs of complying with actions taken record. If any material other than pub- under TSCA and under such other law lic comments or material generated by (or laws); and a hearing is added to the record after (iii) The relative efficiency of actions publication of the notice required by under TSCA and under such other law this section, and notice of its future

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addition was not given at the time of quirements of paragraph (a) of this sec- that initial publication, a separate tion. FEDERAL REGISTER notice announcing its addition to the record and inviting § 750.4 Public comments. comment shall be published; (a) Main comments shall be post- (3) The due date for public comments, marked or received no later than the which shall be at least two weeks prior time specified in the Notice of Pro- to the informal hearing for main composed Rulemaking and shall contain all ments and no more than two weeks comments on and criticisms of that after the informal hearing for reply Notice by the commenting person, comments; based on information which is or rea- (4) The name, address and office tele- sonably could have been available to phone number of the Record and Hear- that person at the time. ing Clerk for the rulemaking in ques- (b) Reply comments shall be post- tion; and marked or received no later than two (5) A nonbinding target date for weeks after the close of all informal issuing the final rule. hearings on the proposed rule and shall [42 FR 61259, Dec. 1977, as amended at 54 FR be restricted to comments on: 21623, May 19, 1989] (1) Other comments; (2) Material in the hearing record; § 750.3 Record. and (a) No later than the date of proposal (3) Material which was not and could of a rule subject to this part, a rule- not reasonably have been available to making record for that rule shall be es- the commenting party a sufficient tablished. It shall consist of a separate time before main comments were due. identified filing space containing: (c) Extensions of the time for filing (1) All documents required by comments may be granted in writing § 750.2(b); by the Record and Hearing Clerk. Ap- (2) All documents cited in the docu- plication for an extension shall be ments required by § 750.2(b); made in writing. Comments submitted (3) All public comments timely re- after the comment period and all ex- ceived; tensions of it have expired need not be (4) All public hearing transcripts; added to the rulemaking record and (5) All material received during an need not be considered in decisions informal hearing and accepted for the concerning the rule. Unless the Notice record of that hearing; and of Proposed Rulemaking states other- (6) Any other information which the wise, four copies of all comments shall Administrator considers to be relevant be submitted. to such rule and which the Adminis- trator identified, on or before the date § 750.5 Subpoenas. of the promulgation of the rule, in a (a) Where necessary, subpoenas re- notice published in the FEDERAL REG- quiring the production of documentary ISTER. material, the attendance of persons at All material in the record shall be ap- the hearing, or responses to written propriately indexed. Each record shall questions may be issued. Subpoenas be available for public inspection dur- may be issued either upon request as ing normal Agency business hours. Ap- provided in paragraph (b) of this sec- propriate arrangements allowing mem- tion or by EPA on its own motion. bers of the public to copy record mate- (b) All subpoena requests shall be in rials that do not risk the permanent writing. Hearing participants may re- loss of such materials shall be made. quest the issuance of subpoenas as fol- All material required to be included in lows: the record shall be added to the record (1) Subpoenas for the attendance of as soon as feasible after its receipt by persons, and for the production of doc- the Agency. uments or responses to questions at (b) The Record and Hearing Clerk for the legislative hearing may be re- each rulemaking shall be responsible quested at any time up to the deadline for Agency compliance with the re- for filing main comments.

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(2) Subpoenas for production of docu- change during the course of the hear- ments or answers to questions after the ing at the discretion of those presiding legislative hearing may be requested at over it. any time between the beginning of the (c) Opening statements should be legislative hearing and the deadline for brief, and restricted either to points submitting reply comments. that could not have been made in main (c) EPA will rule on all subpoena re- comments, or to emphasizing points quests filed under paragraph (b)(1) of which are made in main comments, but this section no later than the begin- which the participant believes can be ning of the legislative hearing. Such more forcefully urged in the hearing requests may be granted, denied, or de- context. ferred. EPA will rule on all subpoena requests filed under paragraph (b)(2) of § 750.7 Conduct of legislative hearing. this section and all deferred subpoena (a) A panel of EPA employees shall requests filed under paragraph (b)(1) of preside at each hearing conducted this section no later than the promul- under section 6(c)(2)(C) of TSCA. In ap- gation of the final rule. Such requests propriate cases other Executive Branch shall be either granted or denied. employees may also sit with and assist § 750.6 Participation in informal hear- the panel. The membership of the panel ing. may change as different topics arise during the hearing. In general, the (a) Each person or organization desir- panel membership will consist of agen- ing to participate in the informal hear- cy employees with special responsi- ing required by section 6(c)(2)(C) of bility for the final rule or special ex- TSCA shall file a written request to so pertise in the topics under discussion. participate with the Record and Hear- One member of the panel shall be ing Clerk which shall be postmarked or named to chair the proceedings and received no later than three weeks shall attend throughout the hearing, prior to the scheduled start of such unless unavoidably prevented by sick- hearing. The request shall include: ness or similar personal circumstances. (1) A brief statement of the interest of the person or organization in the (b) The panel may question any indi- proceeding; vidual or group participating in the (2) A brief outline of the points to be hearing on any subject relating to the addressed; rulemaking. Cross-examination by oth- (3) An estimate of the time required; ers will normally not be permitted at and this stage. It may be granted in com- (4) If the request comes from an orga- pelling circumstances at the sole dis- nization, a nonbinding list of the per- cretion of the hearing panel. However, sons to take part in the presentation. persons in the hearing audience may Organizations are requested to bring submit questions in writing for the with them, to the extent possible, em- hearing panel to ask the participants, ployees with individual expertise in and the hearing panel may, at their and responsibility for each of the areas discretion, ask these questions. to be addressed. No organization not (c) Participants in the hearing may filing main comments in the rule- submit additional material for the making will be allowed to participate hearing record and shall submit such at the hearing, unless a waiver of this additional material as the hearing requirement is granted in writing by panel may request. All such submis- the Record and Hearing Clerk or the sions shall become part of the record of organization is appearing at the re- the hearing. A verbatim transcript of quest of EPA or under subpoena. the hearing shall be made. (b) No later than one week prior to the start of the hearing, the Record § 750.8 Cross-examination. and Hearing Clerk shall make a hear- (a) After the close of the legislative ing schedule publicly available and hearing conducted under § 750.7, any mail or deliver it to each of the persons participant in that hearing may submit who requested to appear at the hear- a written request for cross-examina- ing. This schedule shall be subject to tion. The request shall be received by

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EPA within one week after a full tran- paragraph (b) of this section, the hear- script of the legislative hearing being at which the cross-examination comes available and shall specify: will be conducted shall commence. One (1) The disputed issue(s) of material or more members of the original panel fact as to which cross-examination is shall preside for the Agency. The panel requested. This shall include an expla- shall have authority to conduct cross- nation of why the questions at issue examination on behalf of any partici- are ‘‘factual’’, rather than of an ana- pant, although as a general rule this lytical or policy nature, the extent to right will not be exercised. The panel which they are in ‘‘dispute’’ in the shall also have authority to modify the light of the record made thus far, and governing ruling in any respect and to the extent to which and why they can make new rulings on group representa- reasonably be considered ‘‘material’’ to tion under section 6(c)(3)(C) of TSCA. A the decision on the final rule; and verbatim transcript of the hearing (2) The person(s) the participant de- shall be made. sires to cross-examine, and an estimate (d)(1) No later than the time set for of the time necessary. This shall in- requesting cross-examination, a hear- clude a statement by the cross-exam- ing participant may request that other ination requested can be expected to alternative methods of clarifying the result in ‘‘full and true disclosure’’ re- record (such as informal conferences or solving the issue of material fact in- the submittal of additional informa- volved. tion) be used. Such requests may be (b) Within one week after receipt of submitted either in lieu of cross-exam- all requests for cross-examination ination requests, or in conjunction under paragraph (a) of this section the with them. hearing panel shall rule on them. The (2) The panel in passing on a cross-ex- ruling shall be served by the Record amination request may as a pre- and Hearing Clerk on all participants condition to ruling on its merits re- who have requested cross-examination and shall be inserted in the record. quire that alternative means of clari- Written notice of the ruling shall be fying the record be used whether or not given to all persons requesting cross- that has been requested under para- examination and all persons to be graph (d)(1) of this section. In such a cross-examined. The ruling shall speci- case the results of the use of such al- fy: ternative means shall be made avail- (1) The issues as to which cross-ex- able to the person requesting cross-examination is granted, amination of a one-week comment pe- (2) The persons to be cross-examined riod, and the panel shall make a final on each issue, ruling on cross-examination within one (3) The persons to be allowed to con- week thereafter. duct cross-examination, and (e) Waivers or extensions of any dead- (4) Time limits for the examination line in this section applicable to per- of each witness by each cross-exam- sons other than EPA may be granted iner. on the record of the hearing by the per- In issuing this ruling, the panel may son chairing it or in writing by the determine that one or more partici- Record and Hearing Clerk. pants who have requested cross-exam- § 750.9 Final rule. ination have the same or similar inter- ests and should be required to choose a (a) As soon as feasible after the dead- single representative for purposes of line for submittal of reply comments, cross-examination. In such a case the the Agency shall issue a final rule. order shall simply assign time for Final versions of the statements re- cross-examination by that single rep- quired by paragraph (b) of § 750.2 shall resentative without identifying the be published in the FEDERAL REGISTER representative further. Subpoenas for together with the final rule. The Agen- witnesses may be issued where nec- cy shall also publish at that time: essary. (1) A list of all material added to the (c) Within one week after the inser- record (other than public comments tion into the record of the ruling under and material from the hearng record)

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which has not previously been listed in 6(e)(3)(B) of the Toxic Substances Con- a FEDERAL REGISTER document, and trol Act (TSCA), 15 U.S.C. 2605(e)(3)(B) (2) The effective date of the rule. with respect to petitions filed pursuant (b) [Reserved] to § 750.11(a) of this part.

APPENDIX A TO SUBPART A OF PART 750 § 750.11 Filing of petitions for exemption. To assist in reading the regulations set forth above, this appendix sets forth the (a) Who may file. Any person seeking principal stages through which rules promul- an exemption from the PCB manufac- gated under section 6 of TSCA will pass. turing ban imposed by section The second column gives the relationship 6(e)(3)(A) of TSCA may file a petition that one date bears to another whenever that for exemption. Petitions must be sub- relationship is specified in the regulations, mitted on an individual basis for each and cites the governing provision. The third column contains estimates of the time that manufacturer or individual affected by a typical rulemaking is likely to require to the 1979 manufacturing ban. reach and complete each stage of these pro- (b) Where to file. All petitions per- ceedings. In drawing up this third column, taining to: we have assumed that 60 days will be allowed (1) PCB use, which includes storage for the submission of main comments; that for use or reuse, manufacture, proc- the legislative phase of the informal hearing essing related to manufacture and use, will take two weeks, and that cross-examina- and distribution in commerce related tion will take four days. Since these are only estimates, in any given rulemaking shorter to use or processing for use, must be or longer times may actually be required for submitted to: OPPT Document Control each of these stages. Officer (7407T), Environmental Protec- tion Agency, 1200 Pennsylvania Ave., Esti- NW., Washington, DC 20460–0001. mated (2) PCB disposal, which includes Stage Timing in relation to other total stages time cleanup, storage for disposal, proc- elapsed (days) essing related to disposal, distribution in commerce related to disposal or Proposed regulation Sec. 750.2. Requests to partici- 3 weeks prior to beginning 53 processing for disposal, and decon- pate in informal of hearing (§ 750.2(a)). tamination, must be submitted to: hearing due. Document Control Officer, Office of Re- Main comments due 2 weeks prior to beginning 60 source Conservation and Recovery of hearing (§ 750.2(c)(3)). Begin informal hear- ...... 74 (5305P), Environmental Protection ing. Agency, 1200 Pennsylvania, NW., Wash- End legislative hear- ...... 88 ington, DC 20460–0001. ing. Requests for cross- 1 week after end of legisla- 95 (c) Content of petition. Each petition examination due. tive hearing (§ 750.8(a)). shall contain the following: Ruling on cross-ex- 1 week after requests are 102 (1) Name, address and telephone num- amination requests. due (§ 750.8(b)). ber of petitioner. Cross-examination 1 week afer ruling on 109 begins. cross-examination re- (2) Description of PCB ban exemption quests (§ 750.8(c)). requested, including items to be manu- Cross-examination ...... 113 factured and nature of manufacturing ends; informal hearing ends. process—such as smelting. Reply comments due 2 weeks after end of infor- 127 (3) Location(s) of manufacturing sites mal hearing (§ 750.4(b)). requiring exemption. (4) Length of time requested for exemption (maximum length of exemp- Subpart B—Interim Procedural tion is 1 year). Rules for Manufacturing Ex- (5) Amount of PCB chemical sub- emptions stance or PCB mixture (by pounds and/ or volume) to be manufactured or used SOURCE: 43 FR 50905, Nov. 1, 1978, unless during requested exemption period and otherwise noted. the manner of release of PCB’s into the environment associated with such § 750.10 Applicability. manufacture or use. Sections 750.10–750.21 apply to all (6) The basis for the petitioner’s con- rulemakings under authority of section tention that under section 6(e)(3)(B)(i)

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of TSCA ‘‘an unreasonable risk of in- vided the activity conforms to the jury to health or environment would terms of the current exemption ap- not result’’ from the granting of his pe- proved by EPA, and the petitioner tition for exemption. complies with the conditions of para- (7) The basis for the petitioner’s con- graph (e)(1) of this section. tention that he meets the criterion of (3) Any petitioner who has been section 6(e)(3)(B)(ii) of TSCA con- granted a TSCA section 6(e)(3)(B) ex- cerning substitutes for PCB’s. emption in a rule prior to May 25, 1994, (8) Quantification of the reasonably and who seeks to increase the amount ascertainable economic consequences of PCBs handled or to change the type of denial of the petition for exemption of activities, the procedures for han- from the 1979 manufacturing ban and dling the PCBs, and any other aspect of an explanation of the manner of com- their existing exemption must submit putation. a new exemption petition to EPA. The (d) Request for further information. The existing exemption activity may con- Agency reserves the right to request tinue until the new submission is ad- further information as to each petition dressed by rulemaking, provided the prior to or after publication of the no- activity conforms to the terms of the tice of proposed rulemaking required original exemption approved by EPA. by § 750.13. (e) Renewal requests. (1) Any peti- [43 FR 50905, Nov. 1, 1978, as amended at 53 FR 12524, Apr. 15, 1988; 59 FR 16998, Apr. 11, tioner who has been granted an exemp- 1994; 72 FR 57238, Oct. 9, 2007; 74 FR 30232, tion under section 6(e)(3)(B) of TSCA, June 25, 2009] on or after May 25, 1994, and who seeks to renew that exemption without § 750.12 Consolidation of rulemakings. changing its terms, must submit a let- All petitions received pursuant to ter by certified mail to EPA requesting § 750.11(a) will be consolidated into one that the exemption be granted for the rulemaking with one informal hearing following year. held on all petitions. (i) This letter must contain a certification by the petitioner that the type § 750.13 Notice of proposed rule- of activities, the procedures for han- making. dling the PCBs, the amount of PCBs Rulemaking for PCB exemptions handled, and any other aspect of the filed pursuant to § 750.11(a) shall begin exemption have not changed from the with the publication of a notice of pro- original exemption petition request. posed rulemaking in the FEDERAL REG- (ii) This letter must be received by ISTER. The notice shall state in sum- EPA at least 6 months prior to the ex- mary form the required information piration of the existing exemption. described in § 750.11(c). Due to time con- (iii) If a petitioner fails to make a straints, the notice need not indicate submission or the submission is not what action EPA proposes to take on timely under this section, the exemp- the exemption petitions. The notice tion will expire 1 year from the effec- shall also be subject to § 750.2(c) with tive date of granting that exemption. the exceptions (1) that the clause ‘‘in (iv) EPA will address a timely sub- addition to the material required under mission of a renewal request by rule- paragraph (b)’’ is eliminated; and (2) making and either grant or deny the that § 750.2(c)(3) is changed to read: request. (2) Any petitioner who has been The due date for public comments, which granted an exemption on or after May shall be (1) thirty days after publication of 25, 1994, and who seeks to increase the the notice of proposed rulemaking for main amount of PCBs handled or to change comments and (2) one week after the close of the type of activities, the procedures the informal hearing for reply comments. for handling the PCBs, and any other [43 FR 50905, Nov. 1, 1978, as amended at 59 aspect of their existing exemption FR 16998, Apr. 11, 1994] must submit a new exemption petition to EPA. The existing exemption activ- § 750.14 Record. ity may continue until the new submis- Section 750.3 shall be applicable with sion is addressed by rulemaking, pro- the exception that the words

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‘‘§ 750.11(c)’’ are substituted for 7 days after the close of the 30-day ‘‘§ 750.2(b)’’ in § 750.3(a)(1) and (2). comment period or as soon thereafter [43 FR 50905, Nov. 1, 1978, as amended at 59 as practicable. FR 16998, Apr. 11, 1994] (b) With the exception of the first sentence in § 750.6(a), § 750.6 shall be ap- § 750.15 Public comments. plicable with the further exception Section 750.4 shall be applicable with that the time period in § 750.6(b) is the exception that the time period in shortened to no later than 3 days prior § 750.4(b) is shortened to 1 week. to the start of the hearing.

§ 750.16 Confidentiality. § 750.19 Conduct of informal hearing. The Agency encourages the submis- Section 750.7 shall be applicable with sion of nonconfidential information by the addition of the following sentence petitioners and commenters. The Agen- at the end of § 750.7(c): cy does not wish to have unnecessary restrictions on access to the rule- Participants shall be allowed to designate making record. However, if a petitioner testimony from prior EPA informal rule- or commenter believes that he can only making hearings concerning PCB’s under TSCA. The hearing panel may reject repet- state his position through the use of itive testimony previously presented at such information claimed to be confidential, hearings. he may submit it. Such information must be separately submitted for the § 750.20 Cross-examination. rulemaking record and marked ‘‘confidential’’ by the submitter. For the in- Section 750.8 shall be applicable. formation claimed to be confidential, § 750.21 Final rule. the Agency will list only the date and the name and address of the petitioner (a) As soon as feasible after the dead- or commenter in the public file, noting line for submittal of reply comments, that the petitioner or commenter has the Agency shall issue a final rule. The requested confidential treatment. The Agency shall also publish at that time: information claimed to be confidential (1) A list of all material added to the will be placed in a confidential file. A record (other than public comments petitioner must also file a nonconfiden- and material from the hearing record) tial petition with a nonconfidential which has not previously been listed in summary of the confidential informa- a FEDERAL REGISTER document, and tion to be placed in the public file. (2) The effective date of the rule. Similarly, a commenter must supply a (b) EPA will grant or deny petitions nonconfidential summary of the infor- under section 6(e)(3)(B) of TSCA sub- mation claimed to be confidential to be mitted pursuant to § 750.11. EPA will placed in the public file. Any informa- act on such petitions subsequent to option not marked as confidential will be portunity for an informal hearing pur- placed in the public file. Information suant to this rule. marked confidential will be treated in accordance with the procedures in part (c) In determining whether to grant 2, subpart B of this title. an exemption to the PCB ban, the Agency shall apply the two standards § 750.17 Subpoenas. enunciated in section 6(e)(3)(B) of Section 750.5 shall be applicable. TSCA. [43 FR 50905, Nov. 1, 1978, as amended at 72 § 750.18 Participation in informal FR 57238, Oct. 9, 2007] hearing. (a) Each person or organization desir- Subpart C—Interim Procedural ing to participate in the informal hearing required by section 6(c)(2)(C) of Rules for Processing and Dis- TSCA shall file a written request to so tribution in Commerce Ex- participate with the record and hearing emptions clerk which shall be received no later than 7 days prior to the scheduled start SOURCE: 44 FR 31560, Mar. 31, 1979, unless of the hearing. The hearing shall begin otherwise noted.

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§ 750.30 Applicability. use. Such a petition is not required to Sections 750.30–750.41 apply to all name each person who distributes in rulemakings under authority of section commerce the chemical substance or 6(e)(3)(B) of the Toxic Substances Con- mixture. trol Act (TSCA), 15 U.S.C. 2605(e)(3)(B) (4) PCB capacitor distribution for pur- with respect to petitions for PCB proc- poses of repair. Persons who distribute essing and distribution in commerce in commerce PCB capacitors for serv- exemptions filed pursuant to § 750.31(a) icing (repair) of PCB Equipment may of this part. submit a single consolidated petition on behalf of any number of petitioners § 750.31 Filing of petitions for exemp- engaged in such distribution in com- tion. merce for purposes of repair. The name (a) Who may file. Any person seeking of each petitioner need not be stated in an exemption from the PCB processing the petition. and distribution in commerce prohibi- (5) Small quantities for research and de- tions imposed by section 6(e)(3)(A)(ii) velopment. Persons who process or dis- of TSCA may file a petition for exemp- tribute in commerce small quantities tion. Petitions must be submitted on of PCBs for research and development an individual basis for each processor, may submit a single consolidated peti- distributor, seller or individual af- tion. The name and address of each pe- fected by the 1979 processing and dis- titioner must be stated in the petition. tribution in commerce prohibitions, (6) Microscopy. Persons who process except as described in paragraphs (a) or distribute in commerce PCBs for use (1) through (9) of this section. as a mounting medium in microscopy (1) Processing and distribution in com- may submit a single consolidated peti- merce of PCB-contaminated transformer tion on behalf of any number of peti- dielectric fluid. Persons who process or tioners. The name and address of each distribute in commerce dielectric fluid petitioner must be stated in the peti- containing 50 ppm or greater PCB (but tion. less than 500 ppm PCB) for use in PCB- (7) Processing of PCB Articles into PCB Contaminated Transformers may sub- Equipment. A person who processes (in- mit a single consolidated petition on corporates) PCB Articles (such as small behalf of any number of petitioners. PCB Capacitors) into PCB Equipment The name and address of each peti- may submit a petition on behalf of tioner must be stated in the petition. himself and all persons who further (2) Contaminated substances and mix- process or distribute in commerce PCB tures—processing. Persons who process Equipment built by the petitioner. For the same chemical substance or the example, a builder of motors who same mixture containing 50 ppm or places small PCB Capacitors in the mo- greater PCB as an impurity or con- tors may submit a petition on behalf of taminant may submit a consolidated all persons who process or incorporate petition if the chemical substance or motors built by the petitioner into mixture is processed for the same use other pieces of PCB Equipment and all by each person represented by the peti- those who sell the equipment. Such a tion. For example, persons who process petition is not required to identify the a PCB-contaminated pigment into persons who distribute in commerce or printing inks may combine their peti- further process the PCB Equipment. A tions into one petition. The name and separate petition must be filed, how- address of each petitioner must be stat- ever, by each processor of PCB Articles ed in the petition. into PCB Equipment. (3) Contaminated substances and mix- (8) Processing of PCB Equipment into tures—distribution in commerce. Persons other PCB Equipment. A person who who distribute in commerce the same processes (incorporates) PCB Equip- chemical substance or the same mix- ment into other PCB Equipment may ture containing 50 ppm or greater PCB submit a petition on behalf of himself as an impurity or contaminant may and all persons who further process or submit a consolidated petition if the distribute in commerce PCB Equip- chemical substance or mixture is dis- ment built by the petitioner. Such a tributed in commerce for a common petition is not required to identify the

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persons who distribute in commerce or distributed in commerce, or used dur- further process the PCB Equipment. If ing requested exemption period and the a petition has been filed under para- manner of release of PCBs into the en- graph (a)(7) of this section by the build- vironment associated with such proc- er of the original PCB Equipment, no essing, distribution in commerce, or other petition is required. use. Where the PCB concentration is (9) Distribution of PCB Equipment. Dis- less than 500 ppm, both the total liquid tributors in commerce of PCB Equip- volume and the total PCB volume must ment may submit a consolidated peti- be provided. tion on behalf of persons who dis- (6) The basis for the petitioner’s con- tribute in commerce PCB Equipment of tention that under section 6(e)(3)(B)(i) one type (such as air conditioners). The of TSCA ‘‘an unreasonable risk of in- petition is not required to name the persons who distribute in commerce jury to health or environment would the affected PCB Equipment. not result’’ from the granting of the (b) Where to file. All petitions per- petition for exemption. taining to: (7) The basis for the petitioner’s con- (1) PCB use, which includes storage tention that under section 6(e)(3)(B)(ii) for use or reuse, manufacture, proc- ‘‘good faith efforts have been made to essing related to manufacture and use, develop a chemical substance which and distribution in commerce related does not present an unreasonable risk to use or processing for use, must be of injury to health or the environment submitted to: OPPT Document Control and which may be substituted for’’ the Officer (7407T), Environmental Protec- PCB. tion Agency, 1200 Pennsylvania Ave., (8) Quantification of the reasonably NW., Washington, DC 20460–0001. ascertainable economic consequences (2) PCB disposal, which includes of denying the petition for exemption cleanup, storage for disposal, proc- and an explanation of the manner of essing related to disposal, distribution computation. in commerce related to disposal or (9) In addition to the information in processing for disposal, and decon- paragraphs (c)(1) through (c)(8) of this tamination, must be submitted to: section, certain petitions must contain Document Control Officer, Office of Re- additional information as follows: source Conservation and Recovery (5305P), Environmental Protection (i) Persons who process or distribute Agency, 1200 Pennsylvania Avenue, in commerce dielectric fluids con- NW., Washington, DC 20460–0001. taining 50 ppm or greater PCB for use (c) Content of petition. Each petition in PCB Transformers, railroad trans- must contain the following: formers, or PCB electromagnets must (1) Name, address and telephone num- also state the expected number of PCB ber of petitioner. See also paragraphs Transformers, railroad transformers, (a) (1) through (9) of this section for ad- or PCB electromagnets to be serviced ditional identification requirements under the exemption. In addition, a applicable to certain consolidated peti- person must identify all the facilities tions. which he owns or operates where he (2) Description of PCB processing or services PCB transformers, railroad distribution in commerce exemption transformers, or PCB electromagnets. requested, including a description of (ii) Persons filing petitions under the chemical substances, mixtures or paragraph (a)(1) of this section (Proc- items to be processed or distributed in essing and Distribution in Commerce of commerce and, if processing is in- PCB-Contaminated Transformer Di- volved, the nature of the processing. electric Fluid) must also provide the (3) For processing petitions, loca- expected number of PCB-Contaminated tion(s) of sites requiring exemption. Transformers to be serviced under the (4) Length of time requested for exemption (maximum length of exemp- requested exemption and the expected tion is one year). method of disposal of waste dielectric (5) Estimated amount of PCBs (by fluid. In addition, a person must iden- pound and/or volume) to be processed, tify all the facilities which he owns or

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operates where he services PCB-Con- the processor of PCB Equipment who taminated Transformers. This informa- files the petition must be identified. tion, as well as the information re- (vi) Persons filing petitions under quired by paragraphs (c)(1), (c)(3), and paragraph (a)(9) of this section (Dis- (c)(5) of this section, must be provided tribution of PCB Equipment) must pro- for each person represented by the peti- vide a description of each type of PCB tion. All other information may be pro- Equipment (including the amount of vided on a group basis. PCBs by poundage and/or volume in the (iii) Persons filing petitions under PCB Equipment) to be distributed in paragraphs (a)(2) (Contaminated Sub- commerce under the exemption, the stances and Mixtures-Processing) and number of each type of equipment to be (a)(3) (Contaminated Substances and distributed in commerce, and the ap- Mixtures-Distribution in Commerce) proximate number of distributors cov- must also provide a justification for ered by the petition. All information the class grouping selected and a de- may be provided on a group basis. scription of the uses and the human (vii) Persons filing petitions under and environmental exposure associated paragraphs (a) (5) and (6) of this section with each use of the PCB-contaminated must provide the information required chemical substance or mixture for by paragraphs (c) (1) through (8) of this which an exemption is sought. Infor- section for each petitioner named in mation may be provided on a group the petition. basis, except that the information re- (d) EPA reserves the right to request quired by paragraphs (c)(1), (c)(3) and further information as to each petition (c)(5) of this section, must be provided where necessary to determine whether for each person represented by a peti- the petition meets the statutory tests tion under paragraph (a)(2) of this sec- of section 6(e)(3)(B) of TSCA prior to or tion. after publication of the notice of pro- (iv) Persons filing petitions under posed rulemaking required by § 750.33 of paragraph (a)(4) of this section (PCB these rules. Capacitor Distribution for Purposes of Repair) must also provide an estimate (e) Renewal requests. (1) Any peti- of the expected total number of PCB tioner who has been granted an exemp- Capacitors to be distributed in com- tion under 40 CFR 761.80, except para- merce under the requested exemption. graph (g) of 40 CFR 761.80, on or after All information may be provided on a May 25, 1994, and who seeks to renew group basis. that exemption without changing its (v) Persons filing petitions under terms, must submit a letter by cer- paragraphs (a) (7) and (8) of this section tified mail to EPA requesting that the (Processing of PCB Articles into PCB exemption be granted for the following Equipment and Processing of PCB year. Equipment into Other PCB Equipment) (i) This letter must contain a certifi- must provide a description of each type cation by the petitioner that the type of PCB Equipment (including the of activities, the procedures for han- amount of PCBs by poundage and/or dling the PCBs, the amount of PCBs volume in the PCB Equipment) to be handled, and any other aspect of the processed and/or distributed in com- exemption have not changed from the merce under the exemption, the num- original exemption petition request. ber of each type of equipment expected (ii) This letter must be received by to be processed and/or distributed in EPA at least 6 months prior to the ex- commerce, and the approximate num- piration of the existing exemption. ber of distributors or further proc- (iii) If a petitioner fails to make a essors covered by the petition. All in- submission or the submission is not formation may be provided on a group timely under this section, the exemp- basis. However, in the case of a petition will expire 1 year from the effec- tion under paragraph (a)(7) of this sec- tive date of granting that exemption. tion, the processor of PCB Articles into (iv) EPA will address a timely sub- PCB Equipment must be identified in mission of a renewal request by rule- the petition. In the case of a petition making and either grant or deny the under paragraph (a)(8) of this section, request.

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(2) Any petitioner who has been city at which any informal hearing granted an exemption on or after May shall begin will be given at least 30 25, 1994, and who seeks to increase the days in advance; amount of PCBs handled or to change (c) A statement identifying the place the type of activities, the procedures at which the official record of the rule- for handling the PCBs, and any other making is located, the hours during aspect of their existing exemption which it will be open for public inspec- must submit a new exemption petition tion, the documents contained in it as to EPA. The existing exemption activ- of the date the Notice of Proposed ity may continue until the new submis- Rulemaking was issued, and a state- sion is addressed by rulemaking, pro- ment of the approximate times at vided the activity conforms to the which additional materials such as terms of the current exemption ap- public comments, hearing transcripts, proved by EPA, and the petitioner and Agency studies in progress will be complies with the conditions of para- added to the record. If any material graph (e)(1) of this section. other than public comments or mate- (3) Any petitioner who has been rial generated by a hearing is added to granted a TSCA section 6(e)(3)(B) ex- the record after publication of the no- emption in a rule prior to May 25, 1994, tice required by this action, and notice and who seeks to increase the amount of its future addition was not given at of PCBs handled or to change the type the time of that initial publication, a of activities, the procedures for han- separate FEDERAL REGISTER notice an- dling the PCBs, and any other aspect of nouncing its addition to the record and their existing exemption must submit inviting comment will be published; a new exemption petition to EPA. The (d) The due date for public com- existing exemption activity may con- ments, which will be (1) 30 days after tinue until the new submission is ad- publication of the notice of proposed dressed by rulemaking, provided the rulemaking for main comments and (2) activity conforms to the terms of the one week after the informal hearing for original exemption approved by EPA. reply comments; [44 FR 31560, Mar. 31, 1979, as amended at 53 (e) The name, address, and office FR 12524, Apr. 15, 1988; 59 FR 16998, Apr. 11, telephone number of the Record Clerk 1994; 63 FR 35436, June 29, 1998; 72 FR 57238, and the Hearing Clerk for the rule- Oct. 9, 2007; 74 FR 30232, June 25, 2009] making in question; and (f) A nonbinding target date for § 750.32 Consolidation of rulemaking. issuing the final rule. All petitions received pursuant to § 750.31(a) will be consolidated into one § 750.34 Record. rulemaking with one informal hearing (a) No later than the date of proposal held on all petitions. of a rule subject to this subpart, a rulemaking record for that rule will be es- § 750.33 Notice of proposed rule- tablished. It will consist of a separate making. identified filing space containing: Rulemaking for PCB processing and (1) All documents required by distribution in commerce exemptions § 750.31(d); filed pursuant to § 750.31(a) will begin (2) All public comments timely re- with the publication of a Notice of Pro- ceived; posed Rulemaking in the FEDERAL (3) All public hearing transcripts; REGISTER. Each notice will contain: (4) All material received during an (a) A summary of the information re- informal hearing and accepted for the quired in § 750.31(d); record of that hearing; and (b) A statement of the time and place (5) Any other information that EPA at which the informal hearing required considers to be relevant to such rule by section 6(c)(2)(C) of TSCA shall and that EPA identified, on or before begin, or, to the extent these are not the date of the promulgation of the specified, a statement that they will be rule, in a notice published in the FED- specified later in a separate FEDERAL ERAL REGISTER. REGISTER notice provided that FED- (b) All material in the record will be ERAL REGISTER notice of the date and appropriately indexed. Each record will

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be available for public inspection dur- However, if a petitioner or commentor ing normal EPA business hours. Appro- believes that he can only state his posi- priate arrangements allowing members tion through the use of information of the public to copy record materials claimed to be confidential, he may sub- that do not risk the permanent loss of mit it. Such information must be sepa- such materials will be made. All mate- rately submitted for the rulemaking rial required to be included in the record and marked ‘‘confidential’’ by record will be added to the record as the submitter. For the information soon as feasible after its receipt by claimed to be confidential, EPA will EPA. list only the date and the name and ad- (c) The Record Clerk for each rule- dress of the petitioner or commentor in making will be responsible for EPA the public file, noting that the peti- compliance with the requirements of tioner or commentor has requested paragraph (a) of this section. confidential treatment. The informa- [44 FR 31560, Mar. 31, 1979, as amended at 72 tion claimed to be confidential will be FR 57238, Oct. 9, 2007] placed in a confidential file. A peti- § 750.35 Public comments. tioner must also file a non-confidential petition with a non-confidential sum- (a) Main comments must be post- mary of the confidential information marked or received no later than the to be placed in the public file. Simi- time specified in the Notice of Pro- larly, a commentor must supply a non- posed Rulemaking and must contain confidential summary of the informa- all comments on and criticisms of that Notice by the commenting person, tion claimed to be confidential to be based on information which is or rea- placed in the public file. Any informa- sonably could have been available to tion not marked as confidential will be that person at the time. placed in the public file. Information (b) Reply comments must be postmarked confidential will be treated in marked or received no later than one accordance with the procedures in part week after the close of all informal 2, subpart B of this title. hearings on the proposed rule and must be restricted to comments on: § 750.37 Subpoenas. (1) Other comments; (a) Where necessary, subpoenas re- (2) Material in the hearing record; quiring the production of documentary and material, the attendance of persons at (3) Material which was not and could the hearing, or responses to written not reasonably have been available to questions may be issued. Subpoenas the commenting party a sufficient may be issued either upon request as time before main comments were due. provided in paragraph (b) of this sec- (c) Extensions of the time for filing tion or by EPA on its own motion. comments may be granted in writing (b) All subpoena requests must be in by the Hearing Chairman. Application writing. Hearing participants may re- for an extension must be made in writ- quest the issuance of subpoenas as fol- ing. Comments submitted after the lows: comment period and all extensions of it have expired need not be added to the (1) Subpoenas for the attendance of rulemaking record and need not be con- persons or for the production of docu- sidered in decisions concerning the ments or responses to questions at the rule. legislative hearing may be requested at (d) Unless the Notice of Proposed any time up to the deadline for filing Rulemaking states otherwise, four cop- main comments. ies of all comments must be submitted. (2) Subpoenas for production of documents or answers to questions after the § 750.36 Confidentiality. legislative hearing may be requested at EPA encourages the submission of any time between the beginning of the non-confidential information by peti- legislative hearing and the deadline for tioners and commentors. EPA does not submitting reply comments. wish to have unnecessary restrictions (c) EPA will rule on all subpoena re- on access to the rulemaking record. quests filed under paragraph (b)(1) of

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this section no later than the begin- comments or to emphasizing points ning of the informal hearing. Such re- which are made in main comments, but quests may be granted, denied, or de- which the participant believes can be ferred. EPA will rule on all subpoena more forcefully urged in the hearing requests filed under paragraph (b)(2) of context. this section and all deferred subpoena requests filed under paragraph (b)(1) of § 750.39 Conduct of informal hearing. this section no later than the promul- (a) A panel of EPA employees shall gation of the final rule. Such requests preside at each hearing conducted will be either granted or denied. under section 6(c)(2)(C) of TSCA. In appropriate cases, other Executive § 750.38 Participation in informal hearing. Branch employees may also sit with and assist the panel. The membership (a) Each person or organization desir- of the panel may change as different ing to participate in the informal hear- topics arise during the hearing. In gen- ing required by section 6(c)(2)(C) of eral, the panel membership will consist TSCA must file a written request to of EPA employees with special respon- participate with the Hearing Clerk. sibility for the final rule or special ex- This request must be received no later pertise in the topics under discussion. than seven days prior to the scheduled One member of the panel will be named start of the hearing. The hearing will to chair the proceedings and will at- begin seven days after the close of the tend throughout the hearing, unless thirty day comment period or as soon unavoidably prevented by sickness or thereafter as practicable. The request similar personal circumstances. must include: (1) A brief statement of the interest (b) The panel may question any indi- of the person or organization in the vidual or group participating in the proceeding; hearing on any subject relating to the (2) A brief outline of the points to be rulemaking. Cross-examination by oth- addressed; ers will normally not be permitted at (3) An estimate of the time required; this stage. It may be granted in com- and pelling circumstances at the sole dis- (4) If the request comes from an orga- cretion of the hearing panel. However, nization, a nonbinding list of the per- persons in the hearing audience may sons to take part in the presentation. submit questions in writing for the Organizations are requested to bring hearing panel to ask the participants, with them, to the extent possible, em- and the hearing panel may, at their ployees with individual expertise in discretion, ask these questions. and responsibility for each of the areas (c) Participants in the hearing may to be addressed. No organization not submit additional material for the filing main comments in the rule- hearing record and shall submit such making will be allowed to participate additional material as the hearing at the hearing, unless a waiver of this panel may request. All such submis- requirement is granted in writing by sions will become part of the record of the Hearing Chairman or the organiza- the hearing. A verbatim transcript of tion is appearing at the request of EPA the hearing shall be made. Participants or under subpoena. will be allowed to designate testimony (b) No later than three days prior to from prior EPA informal rulemaking the start of the hearing, the Hearing hearings concerning PCBs under TSCA. Clerk will make a hearing schedule The hearing panel may reject repet- publicly available and mail or deliver itive testimony previously presented at it to each of the persons who requested such hearings. to appear at the hearing. This schedule will be subject to change during the § 750.40 Cross-examination. course of the hearing at the discretion (a) After the close of the informal of those presiding over it. hearing conducted under § 750.39, any (c) Opening statements should be participant in that hearing may submit brief, and restricted either to points a written request for cross-examina- that could not have been made in main tion. The request must be received by

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EPA within one week after a full tran- more members of the original panel script of the informal hearing becomes will preside for EPA. The panel will available and must specify: have authority to conduct cross-exam- (1) The disputed issue(s) of material ination on behalf of any participant, fact as to which cross-examination is although as a general rule this right requested. This must include an expla- will not be exercised. The panel will nation of why the questions at issue also have authority to modify the gov- are ‘‘factual’’, rather than of an ana- erning ruling in any respect and to lytical or policy nature, the extent to make new rulings on group representa- which they are in ‘‘dispute’’ in the tion under section 6(c)(3)(C) of TSCA. A light of the record made thus far, and verbatim transcript of the hearing will the extent to which and why they can be made. reasonably be considered ‘‘material’’ to (e)(1) No later than the time set for the decision on the final rule; and requesting cross-examination, a hear- (2) The person(s) the participant de- ing participant may request that other sires to cross-examine, and an estimate alternative methods of clarifying the of the time necessary. This must include a statement as to how the cross- record (such as informal conferences or examination requested can be expected the submittal of additional informa- to result in ‘‘full and true disclosure’’ tion) be used. Such requests may be resolving the issue of material fact in- submitted either in lieu of cross-exam- volved. ination requests, or in conjunction (b) Within one week after receipt of with them. all requests for cross-examination (2) The panel in passing on a cross-ex- under paragraph (a), the hearing panel amination request may, as a pre- will rule on them. The ruling will be condition to ruling on its merits, reserved by the Hearing Clerk on all par- quire that alternative means of clari- ticipants who have requested cross-ex- fying the record be used whether or not amination and will be inserted in the that has been requested under para- record. Written notice of the ruling graph (e)(1) of this section. In such a will be given to all persons requesting case, the results of the use of such al- cross-examination and all persons to be ternative means will be made available cross-examined. The ruling will speci- to the person requesting cross-exam- fy: ination for a one-week comment pe- (1) The issues as to which cross-ex- riod, and the panel will make a final amination is granted; ruling on cross-examination within one (2) The persons to be cross-examined week thereafter. on each issue; (f) Waivers or extensions of any dead- (3) The persons to be allowed to con- line in this section applicable to per- duct cross-examination; and sons other than EPA may be granted (4) Time limits for the examination on the record of the hearing by the per- of each witness by each cross-exam- son chairing it or in writing by the iner. Hearing Chairman. (c) In issuing this ruling, the panel may determine that one or more par- § 750.41 Final rule. ticipants who have requested cross-ex- (a) As soon as feasible after the dead- amination have the same or similar in- line for submittal of reply comments, terests and should be required to choose a single representative for pur- EPA will issue a final rule. EPA will poses of cross-examination by that sin- also publish at that time: gle representative without identifying (1) A list of all material added to the the representative further. Subpoenas record (other than public comments for witnesses may be issued where nec- and material from the hearing record) essary. which has not previously been listed in (d) Within one week after the inser- a FEDERAL REGISTER document, and tion into the record of the ruling under (2) The effective date of the rule. paragraph (b) of this section, the hear- (b) EPA will grant or deny petitions ing at which the cross-examination under section 6(e)(3)(B) of TSCA sub- will be conducted will begin. One or mitted pursuant to § 750.31. EPA will

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act on such petitions subsequent to op- Subpart F—Transboundary Shipments of portunity for an informal hearing pur- PCBs for Disposal suant to this rule. (c) In determining whether to grant 761.91 Applicability. an exemption to the PCB ban, EPA will 761.93 Import for disposal. 761.97 Export for disposal. apply the two standards enunciated in 761.99 Other transboundary shipments. section 6(e)(3)(B) of TSCA. [44 FR 31560, Mar. 31, 1979, as amended at 72 Subpart G—PCB Spill Cleanup Policy FR 57238, Oct. 9, 2007] 761.120 Scope. 761.123 Definitions. PART 761—POLYCHLORINATED 761.125 Requirements for PCB spill cleanup. BIPHENYLS (PCBs) MANUFAC- 761.130 Sampling requirements. TURING, PROCESSING, DISTRIBU- 761.135 Effect of compliance with this policy TION IN COMMERCE, AND USE and enforcement. PROHIBITIONS Subparts H–I [Reserved]

Subpart A—General Subpart J—General Records and Reports Sec. 761.180 Records and monitoring. 761.1 Applicability. 761.185 Certification program and retention 761.2 PCB concentration assumptions for of records by importers and persons gen- use. erating PCBs in excluded manufacturing 761.3 Definitions. processes. 761.19 References. 761.187 Reporting importers and by persons generating PCBs in excluded manufac- Subpart B—Manufacturing, Processing, Dis- turing processes. tribution in Commerce, and Use of 761.193 Maintenance of monitoring records PCBs and PCB Items by persons who import, manufacture, process, distribute in commerce, or use 761.20 Prohibitions and exceptions. chemicals containing inadvertently gen- 761.30 Authorizations. erated PCBs. 761.35 Storage for reuse. Subpart K—PCB Waste Disposal Records Subpart C—Marking of PCBs and PCB and Reports Items 761.202 EPA identification numbers. 761.40 Marking requirements. 761.205 Notification of PCB waste activity 761.45 Marking formats. (EPA Form 7710-53). Subpart D—Storage and Disposal 761.207 The manifest—general requirements. 761.208 Use of the manifest. 761.50 Applicability. 761.209 Retention of manifest records. 761.60 Disposal requirements. 761.210 Manifest discrepancies. 761.61 PCB remediation waste. 761.211 Unmanifested waste report. 761.62 Disposal of PCB bulk product waste. 761.215 Exception reporting. 761.63 PCB household waste storage and 761.218 Certificate of disposal. dsiposal. 761.64 Disposal of wastes generated as a re- Subpart L [Reserved] sult of research and development activities authorized under § 761.30(j) and chem- Subpart M—Determining a PCB Concentra- ical analysis of PCBs. tion for Purposes of Abandonment or 761.65 Storage for disposal. Disposal of Natural Gas Pipeline: Se- 761.70 Incineration. 761.71 High efficiency boilers. lecting Sample Sites, Collecting Sur- 761.72 Scrap metal recovery ovens and face Samples, and Analyzing Standard smelters. PCB Wipe Samples 761.75 Chemical waste landfills. 761.77 Coordinated approval. 761.240 Scope and definitions. 761.79 Decontamination standards and pro- 761.243 Standard wipe sample method and cedures. size. 761.247 Sample site selection for pipe seg- Subpart E—Exemptions ment removal. 761.250 Sample site selection for pipeline 761.80 Manufacturing, processing and dis- section abandonment. tribution in commerce exemptions. 761.253 Chemical analysis.

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761.257 Determining the regulatory status 761.316 Interpreting PCB concentration of sampled pipe. measurements resulting from this sampling scheme. Subpart N—Cleanup Site Characterization Sampling for PCB Remediation Waste Subpart Q—Self-Implementing Alternative in Accordance with § 761.61(a)(2) Extraction and Chemical Analysis Pro- cedures for Non-liquid PCB Remedi- 761.260 Applicability. ation Waste Samples 761.265 Sampling bulk PCB remediation waste and porous surfaces. 761.320 Applicability. 761.267 Sampling non-porous surfaces. 761.323 Sample preparation. 761.326 Conducting the comparison study. 761.269 Sampling liquid PCB remediation waste. Subpart R—Sampling Non-Liquid, Non- 761.272 Chemical extraction and analysis of Metal PCB Bulk Product Waste for Pur- samples. poses of Characterization for PCB Dis- 761.274 Reporting PCB concentrations in posal in Accordance With § 761.62, samples. and Sampling PCB Remediation Waste Subpart O—Sampling To Verify Completion Destined for Off-Site Disposal, in Ac- of Self-Implementing Cleanup and cordance With § 761.61 On-Site Disposal of Bulk PCB Remedi- 761.340 Applicability. ation Waste and Porous Surfaces in 761.345 Form of the waste to be sampled. Accordance with § 761.61(a)(6) 761.346 Three levels of sampling. 761.347 First level sampling—waste from ex- 761.280 Application and scope. isting piles. 761.283 Determination of the number of 761.348 Contemporaneous sampling. samples to collect and sample collection 761.350 Subsampling from composite sam- locations. ples. 761.286 Sample size and procedure for col- 761.353 Second level of sample selection. lecting a sample. 761.355 Third level of sample selection. 761.289 Compositing samples. 761.356 Conducting a leach test. 761.357 Reporting the results of the proce- 761.292 Chemical extraction and analysis of dure used to simulate leachate genera- individual samples and composite sam- tion. ples. 761.358 Determining the PCB concentration 761.295 Reporting and recordkeeping of the of samples of waste. PCB concentrations in samples. 761.359 Reporting the PCB concentrations in 761.298 Decisions based on PCB concentra- samples. tion measurements resulting from sampling. Subpart S—Double Wash/Rinse Method for Decontaminating Non-Porous Surfaces Subpart P—Sampling Non-Porous Surfaces for Measurement-Based Use, Reuse, 761.360 Background. and On-Site or Off-Site Disposal Under 761.363 Applicability. 761.366 Cleanup equipment. § 761.61(a)(6) and Determination 761.369 Pre-cleaning the surface. Under § 761.79(b)(3) 761.372 Specific requirements for relatively clean surfaces. 761.300 Applicability. 761.375 Specific requirements for surfaces 761.302 Proportion of the total surface area coated or covered with dust, dirt, grime, to sample. grease, or another absorbent material. 761.304 Determining sample location. 761.378 Decontamination, reuse, and dis- 761.306 Sampling 1 meter square surfaces by posal of solvents, cleaners, and equip- random selection of halves. ment. 761.308 Sample selection by random number generation on any two-dimensional Subpart T—Comparison Study for Vali- square grid. dating a New Performance-Based De- 761.310 Collecting the sample. contamination Solvent Under 761.312 Compositing of samples. § 761.79(d)(4) 761.314 Chemical analysis of standard wipe test samples. 761.380 Background. 761.383 Applicability. 761.386 Required experimental conditions for the validation study and subsequent use during decontamination.

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761.389 Testing parameter requirements. contaminated surfaces at PCB con- 761.392 Preparing validation study samples. centrations of ≥ 100 μg/100 cm2. 761.395 A validation study. (4) PCBs can be found in liquid, non- 761.398 Reporting and recordkeeping. liquid and multi-phasic (combinations AUTHORITY: 15 U.S.C. 2605, 2607, 2611, 2614, of liquid and non-liquid) forms. A per- and 2616. son should use the following criteria to determine PCB concentrations to de- Subpart A—General termine which provisions of this part apply to such PCBs. § 761.1 Applicability. (i) Any person determining PCB con- (a) This part establishes prohibitions centrations for non-liquid PCBs must of, and requirements for, the manufac- do so on a dry weight basis. ture, processing, distribution in com- (ii) Any person determining PCB con- merce, use, disposal, storage, and centrations for liquid PCBs must do so marking of PCBs and PCB Items. on a wet weight basis. Liquid PCBs (b)(1) This part applies to all persons containing more than 0.5 percent by who manufacture, process, distribute weight non-dissolved material shall be in commerce, use, or dispose of PCBs or analyzed as multi-phasic non-liquid/liq- PCB Items. Substances that are regu- uid mixtures. lated by this part include, but are not (iii) Any person determining the PCB limited to: dielectric fluids; solvents; concentration of samples containing oils; waste oils; heat transfer fluids; PCBs and non-dissolved non-liquid ma- hydraulic fluids; paints or coatings; terials ≥0.5 percent, must separate the sludges; slurries; sediments; dredge non-dissolved materials into non-liquid spoils; soils; materials containing PCBs as a result of spills; and other chemical PCBs and liquid PCBs. For multi-pha- substances or combinations of sub- sic non-liquid/liquid or liquid/liquid stances, including impurities and by- mixtures, the phases shall be separated products and any byproduct, inter- before chemical analysis. Following mediate, or impurity manufactured at phase separation, the PCB concentra- any point in a process. tion in each non-liquid phase shall be (2) Unless otherwise noted, PCB con- determined on a dry weight basis and centrations shall be determined on a the PCB concentration in each liquid weight-per-weight basis (e.g., milli- phase shall be determined separately grams per kilogram), or for liquids, on on a wet weight basis. a weight-per-volume basis (e.g., milli- (iv) Any person disposing of multi- grams per liter) if the density of the phasic non-liquid/liquid or liquid/liquid liquid is also reported. Unless other- mixtures must use the PCB disposal re- wise provided, PCBs are quantified quirements that apply to the indi- based on the formulation of PCBs vidual phase with the highest PCB con- present in the material analyzed. For centration except where otherwise example, measure AroclorTM 1242 PCBs noted. Alternatively, phases may be based on a comparison with AroclorTM separated and disposed of using the 1242 standards. Measure individual con- PCB disposal requirements that apply gener PCBs based on a comparison with to each separated, single-phase mate- individual PCB congener standards. rial. (3) Most provisions in this part apply (5) No person may avoid any provi- only if PCBs are present in concentra- sion specifying a PCB concentration by tions above a specified level. Provi- diluting the PCBs, unless otherwise sions that apply to PCBs at concentra- specifically provided. tions of < 50 ppm apply also to con- (6) Unless otherwise specified, ref- taminated surfaces at PCB concentra- erences to weights or volumes of PCBs tions of ≤ 10 μg/100 cm2. Provisions that in this part apply to the total weight apply to PCBs at concentrations of ≥ 50 or total volume of the material (oil, to < 500 ppm apply also to contami- soil, debris, etc.) that contains regu- nated surfaces at PCB concentrations lated concentrations of PCBs, not the of > 10/100 cm2 to < 100 μg/100 cm2. Pro- calculated weight or volume of only visions that apply to PCBs at con- the PCB molecules contained in the centrations of ≥500 ppm apply also to material.

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(c) Definitions of the terms used in part B provided that such persons com- these regulations are in subpart A. The ply with subpart J of this part, as ap- basic requirements applicable to dis- plicable. posal and marking of PCBs and PCB (3) Persons who process, distribute in Items are set forth in subpart D—Dis- commerce, or use products containing posal of PCBs and PCB Items and in recycled PCBs defined in § 761.3, are ex- subpart C—Marking of PCBs and PCB empt from the requirements of subpart Items. Prohibitions applicable to PCB B of this part, provided that such per- activities are set forth in subpart B— sons comply with subpart J of this Manufacture, Processing, Distribution part, as applicable. in Commerce, and Use of PCBs and (4) Except as provided in § 761.20 (d) PCB Items. Subpart B also includes au- and (e), persons who process, distribute thorizations from the prohibitions. in commerce, or use products con- Subparts C and D set forth the specific taining excluded PCB products as de- requirements for disposal and marking fined in § 761.3, are exempt from the re- of PCBs and PCB Items. quirements of subpart B of this part. (d) Section 15 of the Toxic Sub- (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C. stances Control Act (TSCA) states that 2605) failure to comply with these regula- [44 FR 31542, May 31, 1979, as amended at 49 tions is unlawful. Section 16 imposes li- FR 28189, July 10, 1984; 53 FR 24220, June 27, ability for civil penalties upon any per- 1988; 63 FR 35436, June 29, 1998; 64 FR 33759, son who violates these regulations, and June 24, 1999] the Administrator can establish appropriate remedies for any violations sub- § 761.2 PCB concentration assump- ject to any limitations included in sections for use. tion 16 of TSCA. Section 16 also sub- (a)(1) Any person may assume that jects a person to criminal prosecution transformers with < 3 pounds (1.36 kilo- for a violation which is knowing or grams (kgs)) of fluid, circuit breakers, willful. In addition, section 17 author- reclosers, oil-filled cable, and rectifiers izes Federal district courts to enjoin whose PCB concentration is not estab- activities prohibited by these regula- lished contain PCBs at < 50 ppm. tions, compel the taking of actions re- (2) Any person must assume that quired by these regulations, and issue mineral oil-filled electrical equipment orders to seize PCBs and PCB Items that was manufactured before July 2, manufactured, processed or distributed 1979, and whose PCB concentration is in violation of these regulations. not established is PCB-Contaminated (e) These regulations do not preempt Electrical Equipment (i.e., contains ≥50 other more stringent Federal statutes ppm PCB, but < 500 ppm PCB). All pole- and regulations. top and pad-mounted distribution (f) Unless and until superseded by transformers manufactured before July any new more stringent regulations 2, 1979, must be assumed to be mineral- issued under EPA authorities, or any oil filled. Any person may assume that permits or any pretreatment require- electrical equipment manufactured ments issued by EPA, a state or local after July 2, 1979, is non-PCB (i.e., < 50 government that affect release of PCBs ppm PCBs). If the date of manufacture to any particular medium: of mineral oil-filled electrical equip- (1) Persons who inadvertently manu- ment is unknown, any person must as- facture or import PCBs generated as sume it to be PCB-Contaminated. unintentional impurities in excluded (3) Any person must assume that a manufacturing processes, as defined in transformer manufactured prior to § 761.3, are exempt from the require- July 2, 1979, that contains 1.36 kg (3 ments of subpart B of this part, pro- pounds) or more of fluid other than vided that such persons comply with mineral oil and whose PCB concentra- subpart J of this part, as applicable. tion is not established, is a PCB Trans- (2) Persons who process, distribute in former (i.e., ≥ 500 ppm). If the date of commerce, or use products containing manufacture and the type of dielectric PCBs generated in excluded manufac- fluid are unknown, any person must as- turing processes defined in § 761.3 are sume the transformer to be a PCB exempt from the requirements of sub- Transformer.

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(4) Any person must assume that a Drive, West Conshohocken, PA 19428– capacitor manufactured prior to July 2, 2959. 1979, whose PCB concentration is not Byproduct means a chemical sub- established contains ≥500 ppm PCBs. stance produced without separate com- Any person may assume that a capac- mercial intent during the manufac- itor manufactured after July 2, 1979, is turing or processing of another chem- non-PCB (i.e., < 50 ppm PCBs). If the ical substance(s) or mixture(s). date of manufacture is unknown, any Capacitor means a device for accumu- person must assume the capacitor con- lating and holding a charge of elec- tains ≥500 ppm PCBs. Any person may tricity and consisting of conducting assume that a capacitor marked at the surfaces separated by a dielectric. time of manufacture with the state- Types of capacitors are as follows: ment ‘‘No PCBs’’ in accordance with (1) Small capacitor means a capacitor § 761.40(g) is non-PCB. which contains less than 1.36 kg (3 lbs.) (b) PCB concentration may be estab- of dielectric fluid. The following as- lished by: sumptions may be used if the actual (1) Testing the equipment; or weight of the dielectric fluid is un- (2)(i) A permanent label, mark, or known. A capacitor whose total volume other documentation from the manu- is less than 1,639 cubic centimeters (100 facturer of the equipment indicating cubic inches) may be considered to con- its PCB concentration at the time of tain less than 1.36 kgs (3 lbs.) of dielec- manufacture; and tric fluid and a capacitor whose total (ii) Service records or other docu- volume is more than 3,278 cubic centi- mentation indicating the PCB con- meters (200 cubic inches) must be concentration of all fluids used in serv- sidered to contain more than 1.36 kg (3 icing the equipment since it was first lbs.) of dielectric fluid. A capacitor manufactured. whose volume is between 1,639 and 3,278 [63 FR 35436, June 29, 1998, as amended at 64 cubic centimeters may be considered to FR 33759, June 24, 1999] contain less then 1.36 kg (3 lbs.) of dielectric fluid if the total weight of the § 761.3 Definitions. capacitor is less than 4.08 kg (9 lbs.). For the purpose of this part: (2) Large high voltage capacitor means Administrator means the Adminis- a capacitor which contains 1.36 kg (3 trator of the Environmental Protection lbs.) or more of dielectric fluid and Agency, or any employee of the Agency which operates at 2,000 volts (a.c. or to whom the Administrator may either d.c.) or above. herein or by order delegate his author- (3) Large low voltage capacitor means a ity to carry out his functions, or any capacitor which contains 1.36 kg (3 lbs.) person who shall by operation of law be or more of dielectric fluid and which authorized to carry out such functions. operates below 2,000 volts (a.c. or d.c.). Agency means the United States En- CERCLA means the Comprehensive vironmental Protection Agency. Environmental Response, Compensa- Air compressor system means air com- tion, and Liability Act (42 U.S.C. 9601- pressors, piping, receiver tanks, vol- 9657). ume tanks and bottles, dryers, airlines, Certification means a written state- and related appurtenances. ment regarding a specific fact or rep- Annual document log means the de- resentation that contains the following tailed information maintained at the language: facility on the PCB waste handling at Under civil and criminal penalties of law the facility. for the making or submission of false or Annual report means the written doc- fraudulent statements or representations (18 ument submitted each year by each U.S.C. 1001 and 15 U.S.C. 2615), I certify that disposer and commercial storer of PCB the information contained in or accom- waste to the appropriate EPA Regional panying this document is true, accurate, and Administrator. The annual report is a complete. As to the identified section(s) of this document for which I cannot personally brief summary of the information in- verify truth and accuracy, I certify as the cluded in the annual document log. company official having supervisory respon- ASTM means American Society for sibility for the persons who, acting under my Testing and Materials, 100 Barr Harbor direct instructions, made the verification

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that this information is true, accurate, and Commercial storer of PCB waste means complete. the owner or operator of each facility Chemical substance, (1) except as pro- that is subject to the PCB storage unit vided in paragraph (2) of this defini- standards of § 761.65(b)(1) or (c)(7) or tion, means any organic or inorganic meets the alternate storage criteria of substance of a particular molecular § 761.65(b)(2), and who engages in stor- identity, including: Any combination age activities involving either PCB of such substances occurring in whole waste generated by others or that was or part as a result of a chemical reac- removed while servicing the equipment tion or occurring in nature, and any owned by others and brokered for dis- element or uncombined radical. posal. The receipt of a fee or any other (2) Such term does not include: Any form of compensation for storage serv- mixture; any pesticide (as defined in ices is not necessary to qualify as a the Federal Insecticide, Fungicide, and commercial storer of PCB waste. A Rodenticide Act) when manufactured, generator who only stores its own processed, or distributed in commerce waste is subject to the storage require- for use as a pesticide; tobacco or any ments of § 761.65, but is not required to tobacco product; any source material, obtain approval as a commercial stor- special nuclear material, or byproduct er. If a facility’s storage of PCB waste material (as such terms are defined in generated by others at no time exceeds the Atomic Energy Act of 1954 and reg- a total of 500 gallons of liquid and/or ulations issued under such Act); any non-liquid material containing PCBs at article the sale of which is subject to regulated levels, the owner or operator the tax imposed by section 4181 of the is a commercial storer but is not re- Internal Revenue Code of 1954 (deter- quired to seek EPA approval as a com- mined without regard to any exemp- mercial storer of PCB waste. Storage of tions from such tax provided by section one company’s PCB waste by a related 4182 or section 4221 or any provisions of company is not considered commercial such Code); and any food, food additive, storage. A ‘‘related company’’ includes, drug, cosmetic, or device (as such but is not limited to: a parent company terms are defined in section 201 of the and its subsidiaries; sibling companies Federal Food, Drug, and Cosmetic Act) owned by the same parent company; when manufactured, processed, or dis- companies owned by a common holding tributed in commerce for use as a food, company; members of electric coopera- food additive, drug, cosmetic, or de- tives; entities within the same Execu- vice. tive agency as defined at 5 U.S.C. 105; Chemical waste landfill means a land- and a company having a joint owner- fill at which protection against risk of ship interest in a facility from which injury to health or the environment PCB waste is generated (such as a from migration of PCBs to land, water, jointly owned electric power gener- or the atmosphere is provided from ating station) where the PCB waste is PCBs and PCB Items deposited therein stored by one of the co-owners of the by locating, engineering, and operating facility. A ‘‘related company’’ does not the landfill as specified in § 761.75. include another voluntary member of Cleanup site means the areal extent of the same trade association. Change in contamination and all suitable areas in ownership or title of a generator’s fa- very close proximity to the contamina- cility, where the generator is storing tion necessary for implementation of a PCB waste, does not make the new cleanup of PCB remediation waste, re- owner of the facility a commercial gardless of whether the site was in- storer of PCB waste. tended for management of waste. Designated facility means the off-site Commerce means trade, traffic, trans- disposer or commercial storer of PCB portation, or other commerce: waste designated on the manifest as (1) Between a place in a State and the facility that will receive a mani- any place outside of such State, or fested shipment of PCB waste. (2) Which affects trade, traffic, trans- Disposal means intentionally or acci- portation, or commerce described in dentally to discard, throw away, or paragraph (1) of this definition. otherwise complete or terminate the

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useful life of PCBs and PCB Items. Dis- quirements of paragraphs (1) through posal includes spills, leaks, and other (5) of this definition, or the importa- uncontrolled discharges of PCBs as tion of products containing PCBs as well as actions related to containing, unintentional impurities, which prod- transporting, destroying, degrading, ucts meet the requirements of para- decontaminating, or confining PCBs graphs (1) and (2) of this definition. and PCB Items. (1) The concentration of inadvert- Disposer of PCB waste, as the term is ently generated PCBs in products leav- used in subparts J and K of this part, ing any manufacturing site or im- means any person who owns or oper- ported into the United States must ates a facility approved by EPA for the have an annual average of less than 25 disposal of PCB waste which is regu- ppm, with a 50 ppm maximum. lated for disposal under the require- (2) The concentration of inadvert- ments of subpart D of this part. ently generated PCBs in the compo- Distribute in commerce and Distribution nents of detergent bars leaving the in Commerce when used to describe an manufacturing site or imported into action taken with respect to a chem- the United States must be less than 5 ical substance, mixture, or article con- ppm. taining a substance or mixture means (3) The release of inadvertently gen- to sell, or the sale of, the substance, erated PCBs at the point at which mixture, or article in commerce; to in- emissions are vented to ambient air troduce or deliver for introduction into must be less than 10 ppm. commerce, or the introduction or de- (4) The amount of inadvertently gen- livery for introduction into commerce erated PCBs added to water discharged of the substance, mixture, or article; or from a manufacturing site must be less to hold or the holding of, the sub- than 100 micrograms per resolvable gas stance, mixture, or article after its in- chromatographic peak per liter of troduction into commerce. water discharged. DOT means the United States De- (5) Disposal of any other process partment of Transportation. wastes above concentrations of 50 ppm Dry weight means the weight of the PCB must be in accordance with subsample, excluding the weight of the part D of this part. water in the sample. Prior to chemical Excluded PCB products means PCB analysis the water may be removed by materials which appear at concentra- any reproducible method that is appli- tions less than 50 ppm, including but cable to measuring PCBs in the sample not limited to: matrix at the concentration of con- (1) Non-Aroclor inadvertently gen- cern, such as air drying at ambient erated PCBs as a byproduct or impu- temperature, filtration, decantation, rity resulting from a chemical manu- heating at low temperature followed by facturing process. cooling in the presence of a desiccant, (2) Products contaminated with or other processes or combinations of Aroclor or other PCB materials from processes which would remove water historic PCB uses (investment casting but not remove PCBs from the sample. waxes are one example). Analytical procedures which calculate (3) Recycled fluids and/or equipment the dry weight concentration by ad- contaminated during use involving the justing for moisture content may also products described in paragraphs (1) be used. and (2) of this definition (heat transfer EPA identification number means the and hydraulic fluids and equipment and 12-digit number assigned to a facility other electrical equipment components by EPA upon notification of PCB waste and fluids are examples). activity under § 761.205. (4) Used oils, provided that in the Excluded manufacturing process means cases of paragraphs (1) through (4) of a manufacturing process in which this definition: quantities of PCBs, as determined in (i) The products or source of the accordance with the definition of inad- products containing < 50 ppm con- vertently generated PCBs, calculated centration PCBs were legally manufac- as defined, and from which releases to tured, processed, distributed in com- products, air, and water meet the re- merce, or used before October 1, 1984.

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(ii) The products or source of the an industrial facility, a control room, products containing < 50 ppm con- and a work station at an assembly line. centrations PCBs were legally manu- Importer means any person defined as factured, processed, distributed in com- an ‘‘importer’’ at § 720.3(l) of this chap- merce, or used, i.e., pursuant to au- ter who imports PCBs or PCB Items thority granted by EPA regulation, by and is under the jurisdiction of the exemption petition, by settlement United States. agreement, or pursuant to other Agen- Impurity means a chemical substance cy-approved programs; which is unintentionally present with (iii) The resulting PCB concentration another chemical substance. (i.e. below 50 ppm) is not a result of di- In or Near Commercial Buildings means lution, or leaks and spills of PCBs in within the interior of, on the roof of, concentrations over 50 ppm. attached to the exterior wall of, in the Facility means all contiguous land, parking area serving, or within 30 me- and structures, other appurtenances, ters of a non-industrial non-substation and improvements on the land, used for building. Commercial buildings are the treatment, storage, or disposal of typically accessible to both members PCB waste. A facility may consist of of the general public and employees, one or more treatment, storage, or dis- and include: (1) Public assembly prop- posal units. erties, (2) educational properties, (3) in- Fluorescent light ballast means a de- stitutional properties, (4) residential vice that electrically controls fluores- properties, (5) stores, (6) office build- cent light fixtures and that includes a ings, and (7) transportation centers capacitor containing 0.1 kg or less of (e.g., airport terminal buildings, sub- dielectric. way stations, bus stations, or train sta- Generator of PCB waste means any tions). person whose act or process produces Incinerator means an engineered de- PCBs that are regulated for disposal vice using controlled flame combustion under subpart D of this part, or whose to thermally degrade PCBs and PCB act first causes PCBs or PCB Items to Items. Examples of devices used for in- become subject to the disposal require- cineration include rotary kilns, liquid ments of subpart D of this part, or who injection incinerators, cement kilns, has physical control over the PCBs and high temperature boilers. when a decision is made that the use of Industrial building means a building the PCBs has been terminated and directly used in manufacturing or tech- therefore is subject to the disposal re- nically productive enterprises. Indus- quirements of subpart D of this part. trial buildings are not generally or Unless another provision of this part typically accessible to other than specifically requires a site-specific workers. Industrial buildings include meaning, ‘‘generator of PCB waste’’ in- buildings used directly in the produc- cludes all of the sites of PCB waste tion of power, the manufacture of prod- generation owned or operated by the ucts, the mining of raw materials, and person who generates PCB waste. the storage of textiles, petroleum prod- High occupancy area means any area ucts, wood and paper products, chemi- where PCB remediation waste has been cals, plastics, and metals. disposed of on-site and where occu- Laboratory means a facility that ana- pancy for any individual not wearing lyzes samples for PCBs and is unaffili- dermal and respiratory protection for a ated with any entity whose activities calendar year is: 840 hours or more (an involve PCBs. average of 16.8 hours or more per week) Leak or leaking means any instance for non-porous surfaces and 335 hours in which a PCB Article, PCB Con- or more (an average of 6.7 hours or tainer, or PCB Equipment has any more per week) for bulk PCB remedi- PCBs on any portion of its external ation waste. Examples could include a surface. residence, school, day care center, Liquid PCBs means a homogenous sleeping quarters, a single or multiple flowable material containing PCBs and occupancy 40 hours per week work sta- no more than 0.5 percent by weight tion, a school class room, a cafeteria in non-dissolved material.

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Low occupancy area means any area Market/Marketers means the proc- where PCB remediation waste has been essing or distributing in commerce, or disposed of on-site and where occu- the person who processes or distributes pancy for any individual not wearing in commerce, used oil fuels to burners dermal and respiratory protection for a or other marketers, and may include calendar year is: less than 840 hours (an the generator of the fuel if it markets average of 16.8 hours per week) for non- the fuel directly to the burner. porous surfaces and less than 335 hours Mineral Oil PCB Transformer means (an average of 6.7 hours per week) for any transformer originally designed to bulk PCB remediation waste. Examples contain mineral oil as the dielectric could include an electrical substation fluid and which has been tested and or a location in an industrial facility found to contain 500 ppm or greater where a worker spends small amounts PCBs. of time per week (such as an unoccu- Mixture means any combination of pied area outside a building, an elec- two or more chemical substances if the trical equipment vault, or in the non- combination does not occur in nature office space in a warehouse where occu- and is not, in whole or in part, the re- pancy is transitory). sult of a chemical reaction; except that Manifest means the shipping docu- such term does include any combina- ment EPA form 8700–22 and any con- tion which occurs, in whole or in part, tinuation sheet attached to EPA form as a result of a chemical reaction if 8700–22, originated and signed by the none of the chemical substances com- generator of PCB waste in accordance prising the combination is a new chem- with the instructions included with the ical substance and if the combination form and subpart K of this part. could have been manufactured for com- Manned Control Center means an elec- mercial purposes without a chemical trical power distribution control room reaction at the time the chemical substances comprising the combination where the operating conditions of a were combined. PCB Transformer are continuously Municipal solid wastes means garbage, monitored during the normal hours of refuse, sludges, wastes, and other dis- operation (of the facility), and, where carded materials resulting from resi- the duty engineers, electricians, or dential and non-industrial operations other trained personnel have the capa- and activities, such as household ac- bility to deenergize a PCB Transformer tivities, office functions, and commer- completely within 1 minute of the re- cial housekeeping wastes. ceipt of a signal indicating abnormal Natural gas pipeline system means nat- operating conditions such as an over- ural gas gathering facilities, natural temperature condition or overpressure gas pipe, natural gas compressors, nat- condition in a PCB Transformer. ural gas storage facilities, and natural Manufacture means to produce, man- gas pipeline appurtenances (including ufacture, or import into the customs instrumentation and vessels directly in territory of the United States. contact with transported natural gas Manufacturing process means all of a such as valves, regulators, drips, filter series of unit operations operating at a separators, etc., but not including air site, resulting in the production of a compressors). product. Non-liquid PCBs means materials con- Mark means the descriptive name, in- taining PCBs that by visual inspection structions, cautions, or other informa- do not flow at room temperature (25 °C tion applied to PCBs and PCB Items, or or 77 °F) or from which no liquid passes other objects subject to these regula- when a 100 g or 100 ml representative tions. sample is placed in a mesh number 60 Marked means the marking of PCB ±5 percent paint filter and allowed to Items and PCB storage areas and trans- drain at room temperature for 5 min- port vehicles by means of applying a utes. legible mark by painting, fixation of an Non-PCB Transformer means any adhesive label, or by any other method transformer that contains less than 50 that meets the requirements of these ppm PCB; except that any transformer regulations. that has been converted from a PCB

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Transformer or a PCB-Contaminated tors, transformers, electric motors, Transformer cannot be classified as a pumps, pipes and any other manufac- non-PCB Transformer until reclassi- tured item (1) which is formed to a spe- fication has occurred, in accordance cific shape or design during manufac- with the requirements of ture, (2) which has end use function(s) § 761.30(a)(2)(v). dependent in whole or in part upon its Non-porous surface means a smooth, shape or design during end use, and (3) unpainted solid surface that limits pen- which has either no change of chemical etration of liquid containing PCBs be- composition during its end use or only yond the immediate surface. Examples those changes of composition which are: smooth uncorroded metal; natural have no commercial purpose separate gas pipe with a thin porous coating from that of the PCB Article. originally applied to inhibit corrosion; PCB Article Container means any smooth glass; smooth glazed ceramics; package, can, bottle, bag, barrel, drum, impermeable polished building stone tank, or other device used to contain such as marble or granite; and high PCB Articles or PCB Equipment, and density plastics, such as whose surface(s) has not been in direct polycarbonates and melamines, that do contact with PCBs. not absorb organic solvents. PCB bulk product waste means waste NTIS means the National Technical derived from manufactured products Information Service, U.S. Department containing PCBs in a non-liquid state, of Commerce, 5285 Port Royal Rd., at any concentration where the con- Springfield, VA 22161. centration at the time of designation On site means within the boundaries for disposal was ≥50 ppm PCBs. PCB of a contiguous property unit. bulk product waste does not include Open burning means the combustion PCBs or PCB Items regulated for dis- of any PCB regulated for disposal, in a posal under § 761.60(a) through (c), manner not approved or otherwise al- § 761.61, § 761.63, or § 761.64. PCB bulk lowed under subpart D of this part, and product waste includes, but is not lim- without any of the following: ited to: (1) Control of combustion air to maintain adequate temperature for ef- (1) Non-liquid bulk wastes or debris ficient combustion. from the demolition of buildings and (2) Containment of the combustion other man-made structures manufac- reaction in an enclosed device to pro- tured, coated, or serviced with PCBs. vide sufficient residence time and mix- PCB bulk product waste does not in- ing for complete combustion. clude debris from the demolition of (3) Control of emission of the gaseous buildings or other man-made struc- combustion products. tures that is contaminated by spills PCB and PCBs means any chemical from regulated PCBs which have not substance that is limited to the been disposed of, decontaminated, or biphenyl molecule that has been otherwise cleaned up in accordance chlorinated to varying degrees or any with subpart D of this part. combination of substances which con- (2) PCB-containing wastes from the tains such substance. Refer to § 761.1(b) shredding of automobiles, household for applicable concentrations of PCBs. appliances, or industrial appliances. PCB and PCBs as contained in PCB (3) Plastics (such as plastic insula- items are defined in § 761.3. For any tion from wire or cable; radio, tele- purposes under this part, inadvertently vision and computer casings; vehicle generated non-Aroclor PCBs are de- parts; or furniture laminates); fined as the total PCBs calculated fol- preformed or molded rubber parts and lowing division of the quantity of components; applied dried paints, var- monochlorinated biphenyls by 50 and nishes, waxes or other similar coatings dichlorinated biphenyls by 5. or sealants; caulking; adhesives; paper; PCB Article means any manufactured Galbestos; sound deadening or other article, other than a PCB Container, types of insulation; and felt or fabric that contains PCBs and whose sur- products such as gaskets. face(s) has been in direct contact with (4) Fluorescent light ballasts con- PCBs. ‘‘PCB Article’’ includes capaci- taining PCBs in the potting material.

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PCB Capacitor means any capacitor cation or identification of inter- that contains ≥500 ppm PCB. Con- ferences with the measurement of the centration assumptions applicable to PCBs. PCB field screening test tech- capacitors appear under § 761.2. nologies include, but are not limited PCB Container means any package, to, total chlorine colorimetric tests, can, bottle, bag, barrel, drum, tank, or total chlorine x-ray fluorescence tests, other device that contains PCBs or total chlorine microcoulometric tests, PCB Articles and whose surface(s) has and rapid immunoassay tests. been in direct contact with PCBs. PCB household waste means PCB PCB-Contaminated means a non-liquid waste that is generated by residents on material containing PCBs at con- the premises of a temporary or perma- centrations ≥50 ppm but < 500 ppm; a nent residence for individuals (includ- liquid material containing PCBs at ing individually owned or rented units concentrations ≥50 ppm but < 500 ppm of a multi-unit construction), and that or where insufficient liquid material is is composed primarily of materials available for analysis, a non-porous found in wastes generated by con- surface having a surface concentration sumers in their homes. PCB household >10 μg/100 cm2 but < 100 μg/100 cm2, waste includes unwanted or discarded measured by a standard wipe test as non-commercial vehicles (prior to defined in § 761.123. shredding), household items, and appli- PCB-Contaminated Electrical Equip- ances or appliance parts and wastes ment means any electrical equipment generated on the premises of a resi- including, but not limited to, trans- dence for individuals as a result of rou- formers (including those used in rail- tine household maintenance by or on way locomotives and self-propelled behalf of the resident. Bulk or commin- cars), capacitors, circuit breakers, re- gled liquid PCB wastes at concentra- closers, voltage regulators, switches tions of ≥50 ppm, demolition and ren- (including sectionalizers and motor ovation wastes, and industrial or heavy starters), electromagnets, and cable, duty equipment with PCBs are not that contains PCBs at concentrations household wastes. of ≥ 50 ppm and < 500 ppm in the con- PCB Item means any PCB Article, taminating fluid. In the absence of liq- PCB Article Container, PCB Container, uids, electrical equipment is PCB-Con- PCB Equipment, or anything that de- taminated if it has PCBs at > 10 μg/100 liberately or unintentionally contains cm2 and < 100 μg/100 cm2 as measured or has as a part of it any PCB or PCBs. by a standard wipe test (as defined in PCB/radioactive waste means PCBs § 761.123) of a non-porous surface. regulated for disposal under subpart D PCB Equipment means any manufac- of this part that also contain source, tured item, other than a PCB Con- special nuclear, or byproduct material tainer or a PCB Article Container, subject to regulation under the Atomic which contains a PCB Article or other Energy Act of 1954, as amended, or nat- PCB Equipment, and includes micro- urally-occurring or accelerator-pro- wave ovens, electronic equipment, and duced radioactive material. fluorescent light ballasts and fixtures. PCB remediation waste means waste PCB field screening test means a port- containing PCBs as a result of a spill, able analytical device or kit which release, or other unauthorized disposal, measures PCBs. PCB field screening at the following concentrations: Mate- tests usually report less than or great- rials disposed of prior to April 18, 1978, er than a specific numerical PCB con- that are currently at concentrations centration. These tests normally build ≥ 50 ppm PCBs, regardless of the con- in a safety factor which increases the centration of the original spill; mate- probability of a false positive report rials which are currently at any vol- and decreases the probability of a false ume or concentration where the origi- negative report. PCB field screening nal source was ≥ 500 ppm PCBs begin- tests do not usually provide: an iden- ning on April 18, 1978, or ≥ 50 ppm PCBs tity record generated by an instru- beginning on July 2, 1979; and mate- ment; a quantitative comparison rials which are currently at any con- record from calibration standards; any centration if the PCBs are spilled or re- identification of PCBs; and/or any indi- leased from a source not authorized for

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use under this part. PCB remediation to, paint or coating on metal; corroded waste means soil, rags, and other de- metal; fibrous glass or glass wool; bris generated as a result of any PCB unglazed ceramics; ceramics with a po- spill cleanup, including, but not lim- rous glaze; porous building stone such ited to: as sandstone, travertine, limestone, or (1) Environmental media containing coral rock; low-density plastics such as PCBs, such as soil and gravel; dredged styrofoam and low-density poly- materials, such as sediments, settled ethylene; coated (varnished or painted) sediment fines, and aqueous decantate or uncoated wood; concrete or cement; from sediment. plaster; plasterboard; wallboard; rub- (2) Sewage sludge containing < 50 ber; fiberboard; chipboard; asphalt; or ppm PCBs and not in use according to tar paper. For purposes of cleaning and § 761.20(a)(4); PCB sewage sludge; com- disposing of PCB remediation waste, mercial or industrial sludge contami- porous surfaces have different require- nated as the result of a spill of PCBs ments than non-porous surfaces. including sludges located in or removed from any pollution control de- Posing an exposure risk to food or feed vice; aqueous decantate from an indus- means being in any location where trial sludge. human food or animal feed products (3) Buildings and other man-made could be exposed to PCBs released from structures (such as concrete floors, a PCB Item. A PCB Item poses an expo- wood floors, or walls contaminated sure risk to food or feed if PCBs re- from a leaking PCB or PCB-Contami- leased in any way from the PCB Item nated Transformer), porous surfaces, have a potential pathway to human and non-porous surfaces. food or animal feed. EPA considers PCB sewage sludge means sewage human food or animal feed to include sludge as defined in 40 CFR 503.9(w) items regulated by the U.S. Depart- which contains ≥50 ppm PCBs, as meas- ment of Agriculture or the Food and ured on a dry weight basis. Drug Administration as human food or PCB Transformer means any trans- animal feed; this includes direct addi- former that contains ≥500 ppm PCBs. tives. Food or feed is excluded from For PCB concentration assumptions this definition if it is used or stored in applicable to transformers containing private homes. 1.36 kilograms (3 lbs.) or more of fluid Process means the preparation of a other than mineral oil, see § 761.2. For chemical substance or mixture, after provisions permitting reclassification its manufacture, for distribution in of electrical equipment, including PCB commerce: Transformers, containing ≥500 ppm (1) In the same form or physical state PCBs to PCB-Contaminated Electrical as, or in a different form or physical Equipment, see § 761.30(a) and (h). state from, that in which it was re- PCB waste(s) means those PCBs and ceived by the person so preparing such PCB Items that are subject to the dis- substance or mixture, or posal requirements of subpart D of this (2) As part of an article containing part. the chemical substance or mixture. Performance-based organic decontamination fluid (PODF) means ker- Qualified incinerator means one of the osene, diesel fuel, terpene hydro- following: carbons, and terpene hydrocarbon/alco- (1) An incinerator approved under the hol mixtures. provisions of § 761.70. Any level of PCB Person means any natural or judicial concentration can be destroyed in an person including any individual, cor- incinerator approved under § 761.70. poration, partnership, or association; (2) A high efficiency boiler which any State or political subdivision complies with the criteria of thereof; any interstate body; and any § 761.71(a)(1), and for which the operator department, agency, or instrumen- has given written notice to the appro- tality of the Federal Government. priate EPA Regional Administrator in Porous surface means any surface accordance with the notification re- that allows PCBs to penetrate or pass quirements for the burning of mineral into itself including, but not limited oil dielectric fluid under § 761.71(a)(2).

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(3) An incinerator approved under PCB disposal technologies, treatability section 3005(c) of the Resource Con- studies for PCB disposal technologies servation and Recovery Act (42 U.S.C. which have not been approved, develop- 6925(c)) (RCRA). ment of new disposal technologies, and (4) Industrial furnaces and boilers research on chemical transformation which are identified in 40 CFR 260.10 processes including, but not limited to, and 40 CFR 279.61 (a)(1) and (2) when op- biodegradation. erating at their normal operating tem- Retrofill means to remove PCB or peratures (this prohibits feeding fluids, PCB-contaminated dielectric fluid and above the level of detection, during ei- to replace it with either PCB, PCB-con- ther startup or shutdown operations). taminated, or non-PCB dielectric fluid. Quantifiable Level/Level of Detection Rupture of a PCB Transformer means a means 2 micrograms per gram from violent or non-violent break in the in- any resolvable gas chromatographic tegrity of a PCB Transformer caused peak, i.e. 2 ppm. by an overtemperature and/or over- RCRA means the Resource Conserva- pressure condition that results in the tion and Recovery Act (40 U.S.C. 6901 et release of PCBs. seq.). Sale for purposes other than resale Recycled PCBs means those PCBs means sale of PCBs for purposes of dis- which appear in the processing of paper posal and for purposes of use, except products or asphalt roofing materials where use involves sale for distribution from PCB-contaminated raw materials. in commerce. PCB Equipment which is Processes which recycle PCBs must first leased for purposes of use any meet the following requirements: time before July 1, 1979, will be consid- (1) There are no detectable con- ered sold for purposes other than re- centrations of PCBs in asphalt roofing sale. material products leaving the proc- Sewage sludge means sewage sludge as essing site. defined in § 503.9(w) of this chapter that (2) The concentration of PCBs in contains < 50 ppm (on a dry weight paper products leaving any manufac- basis) PCBs. turing site processing paper products, Small quantities for research and devel- or in paper products imported into the opment means any quantity of PCBs (1) United States, must have an annual av- that is originally packaged in one or erage of less than 25 ppm with a 50 ppm more hermetically sealed containers of maximum. a volume of no more than five (5.0) mil- (3) The release of PCBs at the point liliters, and (2) that is used only for at which emissions are vented to ambi- purposes of scientific experimentation ent air must be less than 10 ppm. or analysis, or chemical research on, or (4) The amount of Aroclor PCBs analysis of, PCBs, but not for research added to water discharged from an as- or analysis for the development of a phalt roofing processing site must at PCB product. all times be less than 3 micrograms per Soil washing means the extraction of liter (μg/L) for total Aroclors (roughly PCBs from soil using a solvent, recov- 3 parts per billion (3 ppb)). Water dis- ering the solvent from the soil, sepa- charges from the processing of paper rating the PCBs from the recovered products must at all times be less than solvent for disposal, and then disposal 3 micrograms per liter (μg/L) for total or reuse of the solvent. Aroclors (roughly 3 ppb), or comply Standard wipe sample means a sample with the equivalent mass-based limita- collected for chemical extraction and tion. analysis using the standard wipe test (5) Disposal of any other process as defined in § 761.123. Except as des- wastes at concentrations of 50 ppm or ignated elsewhere in part 761, the min- greater must be in accordance with imum surface area to be sampled shall subpart D of this part. be 100 cm2. Research and development (R&D) for Storage for disposal means temporary PCB disposal means demonstrations for storage of PCBs that have been des- commercial PCB disposal approvals, ignated for disposal. pre-demonstration tests, tests of major SW–846 means the document having modifications to previously approved the title ‘‘SW-846, Test Methods for

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Evaluating Solid Waste,’’ which is (5) The characteristics and volumes available from either the National of residuals from a particular treat- Technical Information Service (NTIS, ment process. A ‘‘treatability study’’ is U.S. Department of Commerce, 5285 not a mechanism to commercially Port Royal Rd., Springfield, VA 22161, treat or dispose of PCB waste. Treat- telephone: (703) 487-4650 or the U.S. ment is a form of disposal under this Government Printing Office (U.S. GPO, part. 710 North Capitol St., NW., Wash- TSCA means the Toxic Substances ington, DC 20401, telephone: (202) 783- Control Act (15 U.S.C. 2601 et seq.). 3238. TSCA PCB Coordinated Approval Totally enclosed manner means any means the process used to recognize manner that will ensure no exposure of other Federal or State waste manage- human beings or the environment to ment documents governing the storage, any concentration of PCBs. cleanup, treatment, and disposal of Transfer facility means any transpor- PCB wastes. It is the mechanism under tation-related facility including load- TSCA for accomplishing review, co- ing docks, parking areas, and other ordination, and approval of PCB waste similar areas where shipments of PCB management activities which are con- waste are held during the normal ducted outside of the TSCA PCB ap- course of transportation. Transport ve- proval process, but require approval hicles are not transfer facilities under under the TSCA PCB regulations at 40 this definition, unless they are used for CFR part 761. the storage of PCB waste, rather than Unit means a particular building, for actual transport activities. Storage structure, or cell used to manage PCB areas for PCB waste at transfer facili- waste (including, but not limited to, a ties are subject to the storage facility building used for PCB waste storage, a standards of § 761.65, but such storage landfill, an industrial boiler, or an in- areas are exempt from the approval re- cinerator). quirements of § 761.65(d) and the record- U.S. GPO means the U.S. Government keeping requirements of § 761.180, un- Printing Office, 710 North Capitol St., less the same PCB waste is stored there NW., Washington, DC 20401. for a period of more than 10 consecu- Waste Oil means used products pri- tive days between destinations. marily derived from petroleum, which Transporter of PCB waste means, for include, but are not limited to, fuel the purposes of subpart K of this part, oils, motor oils, gear oils, cutting oils, any person engaged in the transpor- transmission fluids, hydraulic fluids, tation of regulated PCB waste by air, and dielectric fluids. rail, highway, or water for purposes Wet weight means reporting chemical other than consolidation by a gener- analysis results by including either the ator. weight, or the volume and density, of Transport vehicle means a motor vehi- all liquids. cle or rail car used for the transportation of cargo by any mode. Each (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C. 2605) cargo-carrying body (e.g., trailer, railroad freight car) is a separate trans- [49 FR 25239, June 20, 1984, as amended at 49 port vehicle. FR 28189, July 10, 1984; 49 FR 29066, July 18, Treatability Study means a study in 1984; 49 FR 44638, Nov. 8, 1984; 50 FR 29199, July 17, 1985; 50 FR 32176, Aug. 9, 1985; 53 FR which PCB waste is subjected to a 24220, June 27, 1988; 53 FR 27327, July 19, 1988; treatment process to determine: 54 FR 52745, Dec. 21, 1989; 55 FR 26205, June (1) Whether the waste is amenable to 27, 1990; 58 FR 32061, June 8, 1993; 61 FR 11106, the treatment process; Mar. 18, 1996; 63 FR 35437, June 29, 1998; 64 FR (2) What pretreatment (if any) is re- 33759, June 24, 1999] quired; (3) The optimal process conditions § 761.19 References. needed to achieve the desired treat- (a) [Reserved] ment; (b) Incorporation by reference. The fol- (4) The efficiency of a treatment lowing material is incorporated by ref- process for the specific type of waste erence, and is available for inspection (i.e., soil, sludge, liquid, etc.); or, at the National Archives and Records

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Administration (NARA). For informa- References CFR Citation tion on the availability of this mate- ASTM D 2784–89 Standard Test Meth- § 761.71(b)(2)(vi) rial at NARA, call 202–741–6030, or go od for Sulfur in Liquified Petroleum to: http://www.archives.gov/ Gases (Oxy-hydrogen Burner or federallregister/ Lamp). ASTM D 3178–84 Standard Test Meth- § 761.71(b)(2)(vi) codeloflfederallregulations/ ods for Carbon and Hydrogen in the ibrllocations.html. These Analysis Sample of Coke and Coal. incorporations by reference were ap- ASTM D 3278–89 Standard Test Meth- § 761.75(b)(8)(iii) ods for Flash Point of Liquids by proved by the Director of the Office of Setaflash Closed-Cup Apparatus. the Federal Register. These materials ASTM E 258–67 (Reapproved 1987) § 761.71(b)(2)(vi) are incorporated as they exist on the Standard Test Method for Total Ni- date of approval and a notice of any trogen Inorganic Material by Modi- fied KJELDAHL Method. change in these materials will be published in the FEDERAL REGISTER. Copies of the incorporated material are avail- [47 FR 22098, May 21, 1982, as amended at 49 FR 29067, July 18, 1984; 49 FR 36648, Sept. 19, able for inspection at the EPA Docket 1984; 53 FR 10391, Mar. 31, 1988; 53 FR 12524, Center (EPA/DC), Rm. 3334, EPA West Apr. 15, 1988; 53 FR 21641, June 9, 1988; 57 FR Bldg., 1301 Constitution Ave., NW., 13323, Apr. 16, 1992; 59 FR 33697, June 30, 1994; Washington, DC 20460–0001. Copies of 60 FR 34465, July 3, 1995; 63 FR 35439, June 29, the incorporated material may be ob- 1998; 64 FR 33759, June 24, 1999; 69 FR 18803, tained from the American Society for Apr. 9, 2004; 72 FR 57239, Oct. 9, 2007] Testing and Materials (ASTM), 100 Barr Harbor Drive, West Subpart B—Manufacturing, Proc- Conshohocken, PA 19428–2959. essing, Distribution in Com- merce, and Use of PCBs and References CFR Citation PCB Items ASTM D 93 – 90 Standard Test Meth- § 761.71(b)(2)(vi); ods for Flash Point by Pensky- § 761.75(b)(8)(iii) § 761.20 Prohibitions and exceptions. Martens Closed Tester. ASTM D 129–64 (Reapproved 1978) § 761.71(b)(2)(vi) Except as authorized in § 761.30, the Standard Test Method for Sulfur in activities listed in paragraphs (a) and Petroleum Products (General Bomb (d) of this section are prohibited pursu- Method). ant to section 6(e)(2) of TSCA. The re- ASTM D 240–87 Standard Test Meth- § 761.71(b)(2)(vi) od for Heat of Combustion of Liquid quirements set forth in paragraph (c) of Hydrocarbon Fuel by Bomb Calo- this section and subpart F of this part rimeter. concerning export and import of PCBs ASTM D 482–87 Standard Test Meth- § 761.71(b)(2)(vi) od for Ash from Petroleum Products. and PCB Items for disposal are estab- ASTM D 524–88 Standard Test Meth- § 761.71(b)(2)(vi) lished pursuant to section 6(e)(1) of od for Ramsbottom Carbon Residue TSCA. Subject to any exemptions of Petroleum Products. granted pursuant to section 6(e)(3)(B) ASTM D 808–87 Standard Test Meth- § 761.71(b)(2)(vi) od for Chlorine in New and Used of TSCA, the activities listed in para- Petroleum Products (Bomb Method). graphs (b) and (c) of this section are ASTM D 923–86 Standard Test Meth- § 761.60(g)(1)(ii); prohibited pursuant to section od for Sampling Electrical Insulating (g)(2)(ii) (6)(e)(3)(A) of TSCA. In addition, the Liquids. Administrator hereby finds, under the ASTM D 923–89 Standard Methods of § 761.60(g)(1)(ii); Sampling Electrical Insulating Liq- (g)(2)(ii) authority of section 12(a)(2) of TSCA, uids. that the manufacture, processing, and ASTM D 1266–87 Standard Test Meth- § 761.71(b)(2)(vi) distribution in commerce of PCBs at od for Sulfur in Petroleum Products (Lamp Method). concentrations of 50 ppm or greater ASTM D 1796–83 (Reapproved 1990) § 761.71(b)(2)(vi) and PCB Items with PCB concentra- Standard Test Method for Water and tions of 50 ppm or greater present an Sediment in Fuel Oils by the Cen- unreasonable risk of injury to health trifuge Method (Laboratory Proce- dure). within the United States. This finding ASTM D 2158–89 Standard Test Meth- § 761.71(b)(2)(vi) is based upon the well-documented od for Residues in Liquified Petro- human health and environmental haz- leum (LP) Gases. ard of PCB exposure, the high prob- ASTM D 2709–88 Standard Test Meth- § 761.71(b)(2)(vi) od for Water and Sediment in Dis- ability of human and environmental tillate Fuels by Centrifuge. exposure to PCBs and PCB Items from

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manufacturing, processing, or distribu- § 761.3, provided all applicable condition activities; the potential hazard of tions of § 761.1(f) are met. PCB exposure posed by the transpor- (3) An authorization is not required tation of PCBs or PCB Items within to use those PCB Items which contain the United States; and the evidence or whose surfaces have been in contact that contamination of the environment with excluded PCB products as defined by PCBs is spread far beyond the areas in § 761.3. where they are used. In addition, the (4) An authorization is not required Administrator hereby finds, for pur- to use sewage sludge where the uses are poses of section 6(e)(2)(C) of TSCA, that regulated at parts 257, 258, and 503 of any exposure of human beings or the this chapter. No person may blend or environment to PCBs, as measured or otherwise dilute PCBs regulated for detected by any scientifically accept- disposal, including PCB sewage sludge able analytical method, may be signifi- and sewage sludge not used pursuant to cant, depending on such factors as the parts 257, 258, and 503 of this chapter, quantity of PCBs involved in the expo- for purposes of use or to avoid disposal sure, the likelihood of exposure to hu- requirements under this part. Except mans and the environment, and the ef- as explicitly provided in subpart D of fect of exposure. For purposes of deter- this part, no person may dispose of reg- mining which PCB Items are totally ulated PCB wastes including, but not enclosed, pursuant to section 6(e)(2)(C) limited to, PCB remediation waste, of TSCA, since exposure to such Items PCB bulk product waste, PCBs, and may be significant, the Administrator PCB industrial sludges, into treatment further finds that a totally enclosed works, as defined in § 503.9(aa) of this manner is a manner which results in no chapter. exposure to humans or the environ- (b) No person may manufacture PCBs ment to PCBs. The following activities for use within the United States or are considered totally enclosed: dis- manufacture PCBs for export from the tribution in commerce of intact, non- United States without an exemption, except that: an exemption is not re- leaking electrical equipment such as quired for PCBs manufactured in an ex- transformers (including transformers cluded manufacturing process as de- used in railway locomotives and self- fined in § 761.3, provided all applicable propelled cars), capacitors, conditions of § 761.1(f) are met. electromagnets, voltage regulators, (c) No persons may process or dis- switches (including sectionalizers and tribute in commerce any PCB, or any motor starters), circuit breakers, re- PCB Item regardless of concentration, closers, and cable that contain PCBs at for use within the United States or for any concentration and processing and export from the United States without distribution in commerce of PCB an exemption, except that an exemp- Equipment containing an intact, non- tion is not required to process or dis- leaking PCB Capacitor. See paragraph tribute in commerce PCBs or PCB (c)(1) of this section for provisions al- Items resulting from an excluded man- lowing the distribution in commerce of ufacturing process as defined in § 761.3, PCBs and PCB Items. or to process or distribute in commerce (a) No persons may use any PCB, or recycled PCBs as defined in § 761.3, or any PCB Item regardless of concentra- to process or distribute in commerce tion, in any manner other than in a to- excluded PCB products as defined in tally enclosed manner within the § 761.3, provided that all applicable con- United States unless authorized under ditions of § 761.1(f) are met. In addition, § 761.30, except that: the activities described in paragraphs (1) An authorization is not required (c) (1) through (5) of this section may to use those PCBs or PCB Items which also be conducted without an exemp- consist of excluded PCB products as de- tion, under the conditions specified fined in § 761.3. therein. (2) An authorization is not required (1) PCBs at concentrations of 50 ppm to use those PCBs or PCB Items result- or greater, or PCB Items with PCB con- ing from an excluded manufacturing centrations of 50 ppm or greater, sold process or recycled PCBs as defined in before July 1, 1979 for purposes other

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than resale may be distributed in com- (i) The materials were decontami- merce only in a totally enclosed man- nated in accordance with a TSCA PCB ner after that date. disposal approval issued under subpart (2) Any person may process and dis- D of this part, with § 761.79, or with ap- tribute in commerce for disposal PCBs plicable EPA PCB spill cleanup policies at concentrations of ≥50 ppm, or PCB in effect at the time of the decon- Items with PCB concentrations of ≥50 tamination. ppm, if they comply with the applica- (ii) If not previously decontaminated, ble provisions of this part. the materials now meet an applicable (i) Processing activities which are decontamination standard in § 761.79(b). primarily associated with and facili- (d) The use of waste oil that contains tate storage or transportation for dis- any detectable concentration of PCB as posal do not require a TSCA PCB stor- a sealant, coating, or dust control age or disposal approval. agent is prohibited. Prohibited uses in- (ii) Processing activities which are clude, but are not limited to, road oil- primarily associated with and facili- ing, general dust control, use as a pes- tate treatment, as defined in § 260.10 of ticide or herbicide carrier, and use as a this chapter, or disposal require a rust preventative on pipes. TSCA PCB disposal approval unless (e) In addition to any applicable re- they are part of an existing approval, quirements under 40 CFR part 279, sub- are part of a self-implementing activ- parts G and H, marketers and burners ity under § 761.61(a) or § 761.79 (b) or (c), of used oil who market (process or dis- or are otherwise specifically allowed tribute in commerce) for energy recov- under subpart D of this part. ery, used oil containing any quantifi- (iii) With the exception of provisions able level of PCBs are subject to the in § 761.60 (a)(2) and (a)(3), in order to following requirements: meet the intent of § 761.1(b), processing, (1) Restrictions on marketing. Used oil diluting, or otherwise blending of containing any quantifiable level of waste prior to being introduced into a PCBs (2 ppm) may be marketed only to: disposal unit for purposes of meeting a (i) Qualified incinerators as defined PCB concentration limit shall be done in 40 CFR 761.3. in accordance with a TSCA PCB dis- (ii) Marketers who market off-speci- posal approval or comply with the re- fication used oil for energy recovery quirements of § 761.79. only to other marketers who have noti- (iv) Where the rate of delivering liq- fied EPA of their used oil management uids or non-liquids into a PCB disposal activities, and who have an EPA iden- unit is an operating parameter, this tification number where an identifica- rate shall be a condition of the TSCA tion number is required by 40 CFR PCB disposal approval for the unit 279.73. This would include persons who when an approval is required. market off-specification used oil who (3) PCBs and PCB Items may be ex- are subject to the requirements at 40 ported for disposal in accordance with CFR part 279 and the notification re- the requirements of subpart F of this quirements of 40 CFR 279.73. part. (iii) Burners identified in 40 CFR (4) PCBs, at concentrations of less 279.61(a)(1) and (2). Only burners in the than 50 ppm, or PCB Items, with con- automotive industry may burn used oil centrations of less than 50 ppm, may be generated from automotive sources in processed and distributed in commerce used oil-fired space heaters provided for purposes of disposal. the provisions of 40 CFR 279.23 are met. (5) Decontaminated materials. Any The Regional Administrator may grant person may distribute in commerce a variance for a boiler that does not equipment, structures, or other liquid meet the 40 CFR 279.61(a)(1) and (2) cri- or non-liquid materials that were con- teria after considering the criteria list- taminated with PCBs ≥50 ppm, included in 40 CFR 260.32 (a) through (f). The ing those not otherwise authorized for applicant must address the relevant distribution in commerce under this criteria contained in 40 CFR 260.32 (a) part, provided that one of the following through (f) in an application to the Re- applies: gional Administrator.

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(2) Testing of used oil fuel. Used oil to in paragraph (e)(1) of this section and be burned for energy recovery is pre- identify the class of burner he quali- sumed to contain quantifiable levels (2 fies. ppm) of PCB unless the marketer ob- (4) Recordkeeping requirements. The tains analyses (testing) or other infor- following recordkeeping requirements mation that the used oil fuel does not are in addition to the recordkeeping re- contain quantifiable levels of PCBs. quirements for marketers found in 40 (i) The person who first claims that a CFR 279.72(b), 279.74(a), (b) and (c), and used oil fuel does not contain quantifi- 279.75, and for burners found in 40 CFR able level (2 ppm) PCB must obtain 279.65 and 279.66. analyses or other information to sup- (i) Marketers. Marketers who first port that claim. claim that the used oil fuel contains no (ii) Testing to determine the PCB detectable PCBs must include among concentration in used oil may be con- the records required by 40 CFR 279.72(b) ducted on individual samples, or in ac- and 279.74(b) and (c), copies of the anal- cordance with the testing procedures ysis or other information documenting described in § 761.60(g)(2). However, for his claim, and he must include among purposes of this part, if any PCBs at a the records required by 40 CFR 279.74(a) concentration of 50 ppm or greater and (c) and 279.75, a copy of each cer- have been added to the container or tification notice received or prepared equipment, then the total container relating to transactions involving PCB- contents must be considered as having containing used oil. a PCB concentration of 50 ppm or (ii) Burners. Burners must include greater for purposes of complying with among the records required by 40 CFR the disposal requirements of this part. 279.65 and 279.66, a copy of each certifi- (iii) Other information documenting cation notice required by paragraph that the used oil fuel does not contain (e)(3)(ii) of this section that he sends to quantifiable levels (2 ppm) of PCBs a marketer. may consist of either personal, special knowledge of the source and composi- (Sec. 6, Pub. L. 94–469, 90 Stat. 2020, (15 U.S.C. tion of the used oil, or a certification 2605) from the person generating the used oil [44 FR 31542, May 31, 1979. Redesignated at 47 claiming that the oil contains no de- FR 19527, May 6, 1982, and amended at 49 FR tectable PCBs. 25241, June 20, 1984; 49 FR 28190, July 10, 1984; (3) Restrictions on burning. (i) Used oil 49 FR 44638, Nov. 8, 1984; 53 FR 12524, Apr. 15, containing any quantifiable levels of 1988; 53 FR 24220, June 27, 1988; 58 FR 15435, PCB may be burned for energy recov- Mar. 23, 1993; 58 FR 34205, June 23, 1993; 60 FR ery only in the combustion facilities 34465, July 3, 1995; 61 FR 11106, Mar. 18, 1996; identified in paragraph (e)(1) of this 63 FR 35439, June 29, 1998; 64 FR 33760, June section when such facilities are oper- 24, 1999] ating at normal operating tempera- § 761.30 Authorizations. tures (this prohibits feeding these fuels during either startup or shutdown op- The following non-totally enclosed erations). Owners and operators of such PCB activities are authorized pursuant facilities are ‘‘burners’’ of used oil to section 6(e)(2)(B) of TSCA: fuels. (a) Use in and servicing of transformers (ii) Before a burner accepts from a (other than railroad transformers). PCBs marketer the first shipment of used oil at any concentration may be used in fuel containing detectable PCBs (2 transformers (other than in railroad lo- ppm), the burner must provide the comotives and self-propelled railroad marketer a one-time written and cars) and may be used for purposes of signed notice certifying that: servicing including rebuilding these (A) The burner has complied with transformers for the remainder of their any notification requirements applica- useful lives, subject to the following ble to ‘‘qualified incinerators’’ (§ 761.3) conditions: or to ‘‘burners’’ regulated under 40 CFR (1) Use conditions. (i) As of October 1, part 279, subpart G. 1985, the use and storage for reuse of (B) The burner will burn the used oil PCB Transformers that pose an expo- only in a combustion facility identified sure risk to food or feed is prohibited.

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(ii) As of October 1, 1990, the use of commercial buildings, must be network PCB Transformers with higher equipped with electrical protection to secondary voltages (secondary voltages avoid transformer ruptures caused by equal to or greater than 480 volts, in- high current faults. cluding 480/277 volt systems) in or near (A) Current-limiting fuses or other commercial buildings is prohibited. equivalent technology must be used to Network PCB Transformers with high- detect sustained high current faults er secondary voltages which are re- and provide for the complete moved from service in accordance with deenergization of the transformer this requirement must either be reclas- (within several hundredths of a second sified to PCB Contaminated or non in the case of higher secondary voltage PCB status, placed into storage for dis- radial PCB Transformers and within posal, or disposed. tenths of a second in the case of lower (iii) Except as otherwise provided, as secondary voltage network PCB Trans- of October 1, 1985, the installation of formers), before transformer rupture PCB Transformers, which have been occurs. Lower secondary voltage radial placed into storage for reuse or which PCB Transformers must be equipped have been removed from another loca- with electrical protection as provided tion, in or near commercial buildings in paragraph (a)(1)(iv)(E) of this sec- is prohibited. tion. The installation, setting, and (A) Retrofilled mineral oil PCB maintenance of current-limiting fuses Transformers may be installed for re- or other equivalent technology to classification purposes indefinitely avoid PCB Transformer ruptures from after October 1, 1990. sustained high current faults must be (B) Once a retrofilled transformer has completed in accordance with good en- been installed for reclassification pur- gineering practices. poses, it must be tested 3 months after (B) All lower secondary voltage net- installation to ascertain the concentra- work PCB Transformers not located in tion of PCBs. If the PCB concentration sidewalk vaults (network transformers is below 50 ppm, the transformer can be with secondary voltages below 480 reclassified as a non-PCB Transformer. volts), in use in or near commercial If the PCB concentration is between 50 buildings, which have not been pro- and 500 ppm, the transformer can be re- tected as specified in paragraph classified as a PCB-Contaminated (a)(1)(iv)(A) of this section by October transformer. If the PCB concentration 1, 1990, must be removed from service remains at 500 ppm or greater, the en- by October 1, 1993. tire process must either be repeated (C) As of October 1, 1990, owners of until the transformer has been reclassi- lower secondary voltage network PCB fied to a non-PCB or PCB-Contami- Transformers, in use in or near com- nated transformer in accordance with mercial buildings which have not been paragraph (a)(2)(v) of this section or protected as specified in paragraph the transformer must be removed from (a)(1)(iv)(A) of this section and which service. are not located in sidewalk vaults, (iv) As of October 1, 1990, all higher must register in writing those trans- secondary voltage radial PCB Trans- formers with the EPA Regional Admin- formers, in use in or near commercial istrator in the appropriate region. The buildings, and lower secondary voltage information required to be provided in network PCB Transformers not located writing to the Regional Administrator in sidewalk vaults in or near commer- includes: cial buildings (network transformers (1) The specific location of the PCB with secondary voltages below 480 Transformer(s). volts) that have not been removed from (2) The address(es) of the building(s) service as provided in paragraph and the physical location of the PCB (a)(1)(iv)(B) of this section, must be Transformer(s) on the building site(s). equipped with electrical protection to (3) The identification number(s) of avoid transformer ruptures caused by the PCB Transformer(s). high current faults. As of February 25, (D) As of October 1, 1993, all lower 1991, all lower secondary voltage radial secondary voltage network PCB Trans- PCB Transformers, in use in or near formers located in sidewalk vaults

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(network transformers with secondary control center must occur within 1 voltages below 480 volts) in use near minute of the receipt of the audio or commercial buildings must be removed visual signal indicating an abnormal from service. condition caused by a sustained low (E) As of February 25, 1991, all lower current fault. If automatic operation is secondary voltage radial PCB Trans- selected and a circuit breaker is uti- formers must be equipped with elec- lized for disconnection, it must also trical protection, such as current-lim- have the capability to be manually iting fuses or other equivalent tech- opened if necessary. nology, to detect sustained high cur- (C) The enhanced electrical protec- rent faults and provide for the com- tive system required for the detection plete deenergization of the transformer of sustained low current faults and the or complete deenergization of the complete and rapid deenergization of faulted phase of the transformer within transformers must be properly in- several hundredths of a second. The installed, maintained, and set sensitive stallation, setting, and maintenance of enough (in accordance with good engi- current-limiting fuses or other equiva- neering practices) to detect sustained lent technology to avoid PCB Trans- low current faults and allow for rapid former ruptures from sustained high and total deenergization prior to PCB current faults must be completed in ac- Transformer rupture (either violent or cordance with good engineering prac- non violent rupture) and release of tices. PCBs. (v) As of October 1, 1990, all radial (vi)(A) No later than December 28, PCB Transformers with higher sec- 1998 all owners of PCB Transformers, ondary voltages (480 volts and above, including those in storage for reuse, including 480/277 volt systems) in use in must register their transformers with or near commercial buildings must, in the Environmental Protection Agency, addition to the requirements of para- National Program Chemicals Division, graph (a)(1)(iv)(A) of this section, be Office of Pollution Prevention and equipped with protection to avoid Toxics (7404), 1200 Pennsylvania Ave., transformer ruptures caused by sus- NW., Washington, DC 20460. This reg- tained low current faults. istration requirement is subject to the (A) Pressure and temperature sensors limitations in paragraph (a)(1) of this (or other equivalent technology which section. has been demonstrated to be effective (1) A transformer owner who assumes in early detection of sustained low cur- a transformer is a PCB-Contaminated rent faults) must be used in these transformer, and discovers after De- transformers to detect sustained low cember 28, 1998 that it is a PCB-Trans- current faults. former, must register the newly-identi- (B) Disconnect equipment must be fied PCB Transformer, in writing, with provided to insure complete the Environmental Protection Agency deenergization of the transformer in no later than 30 days after it is identi- the event of a sensed abnormal condi- fied as such. This requirement does not tion (e.g., an overpressure or over- apply to transformer owners who have temperature condition in the trans- previously registered with the EPA former), caused by a sustained low cur- PCB Transformers located at the same rent fault. The disconnect equipment address as the transformer that they must be configured to operate auto- assumed to be PCB-Contaminated and matically within 30 seconds to 1 later determined to be a PCB Trans- minute of the receipt of a signal indi- former. cating an abnormal condition from a (2) A person who takes possession of sustained low current fault, or can be a PCB Transformer after December 28, configured to allow for manual 1998 is not required to register or re- deenergization from a manned on-site register the transformer with the EPA. control center upon the receipt of an (B) Any person submitting a registra- audio or visual signal indicating an ab- tion under this section must include: normal condition caused by a sustained (1) Company name and address. low current fault. Manual (2) Contact name and telephone num- deenergization from a manned on-site ber.

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(3) Address where these transformers (i.e., in a transformer vault or in a par- are located. For mobile sources such as titioned area housing a transformer); ships, provide the name of the ship. within 5 meters of a transformer enclo- (4) Number of PCB Transformers and sure, or, if unenclosed (unpartitioned), the total weight in kilograms of PCBs within 5 meters of a PCB Transformer. contained in the transformers. (ix) A visual inspection of each PCB (5) Whether any transformers at this Transformer (as defined in the defini- location contain flammable dielectric tion of ‘‘PCB Transformer’’ under fluid (optional). § 761.3) in use or stored for reuse shall (6) Signature of the owner, operator, be performed at least once every 3 or other authorized representative cer- months. These inspections may take tifying the accuracy of the information place any time during the 3-month pe- submitted. riods: January-March, April-June, (C) A transformer owner must retain July-September, and October-Decem- a record of each PCB Transformer’s ber as long as there is a minimum of 30 registration (e.g., a copy of the reg- days between inspections. The visual istration and the return receipt signed inspection must include investigation by EPA) with the inspection and main- for any leak of dielectric fluid on or tenance records required for each PCB around the transformer. The extent of Transformer under paragraph the visual inspections will depend on (a)(1)(xii)(I) of this section. the physical constraints of each trans- (D) A transformer owner must com- former installation and should not reply with all requirements of paragraph quire an electrical shutdown of the (a)(1)(vi)(A) of this section to continue transformer being inspected. the PCB-Transformer’s authorization (x) If a PCB Transformer is found to for use, or storage for reuse, pursuant have a leak which results in any quan- to this section and TSCA section tity of PCBs running off or about to 6(e)(2)(B). run off the external surface of the (vii) As of December 1, 1985, PCB transformer, then the transformer Transformers in use in or near com- must be repaired or replaced to elimi- mercial buildings must be registered nate the source of the leak. In all cases with building owners. For PCB Trans- any leaking material must be cleaned formers located in commercial build- up and properly disposed of according ings, PCB Transformer owners must to disposal requirements of subpart D register the transformers with the of this part. Cleanup of the released building owner of record. For PCB PCBs must be initiated as soon as pos- Transformers located near commercial sible, but in no case later than 48 hours buildings, PCB Transformer owners of its discovery. Until appropriate ac- must register the transformers with all tion is completed, any active leak of owners of buildings located within 30 PCBs must be contained to prevent ex- meters of the PCB Transformer(s). In- posure of humans or the environment formation required to be provided to and inspected daily to verify contain- building owners by PCB Transformer ment of the leak. Trenches, dikes, owners includes but is not limited to: buckets, and pans are examples of (A) The specific location of the PCB proper containment measures. Transformer(s). (xi) If a PCB Transformer is involved (B) The principal constituent of the in a fire-related incident, the owner of dielectric fluid in the transformer(s) the transformer must immediately re- (e.g., PCBs, mineral oil, or silicone oil). port the incident to the National Re- (C) The type of transformer installa- sponse Center (toll-free 1–800–424–8802; tion (e.g., 208/120 volt network, 208/120 in Washington, DC 202–426–2675). A fire- volt radial, 208 volt radial, 480 volt net- related incident is defined as any inci- work, 480/277 volt network, 480 volt ra- dent involving a PCB Transformer dial, 480/277 volt radial). which involves the generation of suffi- (viii) As of December 1, 1985, combus- cient heat and/or pressure (by any tible materials, including, but not lim- source) to result in the violent or non- ited to paints, solvents, plastics, paper, violent rupture of a PCB Transformer and sawn wood must not be stored and the release of PCBs. Information within a PCB Transformer enclosure must be provided regarding the type of

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PCB Transformer installation involved may take place any time during the in the fire-related incident (e.g., high calendar year as long as there is a min- or low secondary voltage network imum of 180 days between inspections. transformer, high or low secondary (A) A PCB Transformer which has voltage simple radial system, expanded impervious, undrained, secondary con- radial system, primary selective sys- tainment capacity of at least 100 per- tem, primary loop system, or sec- cent of the total dielectric fluid vol- ondary selective system or other sys- ume of all transformers so contained or tems) and the readily ascertainable (B) A PCB Transformer which has cause of the fire-related incident (e.g., been tested and found to contain less high current fault in the primary or than 60,000 ppm PCBs (after 3 months secondary or low current fault in sec- of in service use if the transformer has ondary). The owner of the PCB Trans- been serviced for purposes of reducing former must also take measures as the PCB concentration). soon as practically and safely possible (xiv) An increased visual inspection to contain and control any potential frequency of at least once every week releases of PCBs and incomplete com- applies to any PCB Transformer in use bustion products into water. These or stored for reuse which poses an ex- measures include, but are not limited posure risk to food or feed. The user of to: a PCB Transformer posing an exposure (A) The blocking of all floor drains in risk to food is responsible for the in- the vicinity of the transformer. spection, recordkeeping, and mainte- (B) The containment of water runoff. nance requirements under this section (C) The control and treatment (prior until the user notifies the owner that to release) of any water used in subse- the transformer may pose an exposure quent cleanup operations. risk to food or feed. Following such no- (xii) Records of inspection and main- tification, it is the owner’s ultimate re- tenance history shall be maintained at sponsibility to determine whether the least 3 years after disposing of the PCB Transformer poses an exposure transformer and shall be made avail- risk to food or feed. able for inspection, upon request by EPA. Such records shall contain the (xv) In the event a mineral oil trans- following information for each PCB former, assumed to contain less than Transformer: 500 ppm of PCBs as provided in § 761.2, (A) Its location. is tested and found to be contaminated (B) The date of each visual inspection at 500 ppm or greater PCBs, it will be and the date that leak was discovered, subject to all the requirements of this if different from the inspection date. part 761. In addition, efforts must be (C) The person performing the inspec- initiated immediately to bring the tion. transformer into compliance in accord- (D) The location of any leak(s). ance with the following schedule: (E) An estimate of the amount of di- (A) Report fire-related incidents, ef- electric fluid released from any leak. fective immediately after discovery. (F) The date of any cleanup, contain- (B) Mark the PCB transformer within ment, repair, or replacement. 7 days after discovery. (G) A description of any cleanup, con- (C) Mark the vault door, machinery tainment, or repair performed. room door, fence, hallway or other (H) The results of any containment means of access to the PCB Trans- and daily inspection required for un- former within 7 days after discovery. corrected active leaks. (D) Register the PCB Transformer in (I) Record of the registration of PCB writing with the building owner within Transformer(s). 30 days of discovery. (J) Records of transfer of ownership (E) Install electrical protective in compliance with § 761.180(a)(2)(ix). equipment on a radial PCB Trans- (xiii) A reduced visual inspection fre- former and a non-sidewalk vault, lower quency of at least once every 12 secondary voltage network PCB Trans- months applies to PCB Transformers former in or near a commercial build- that utilize either of the following risk ing within 18 months of discovery or by reduction measures. These inspections October 1, 1990, whichever is later.

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(F) Remove a non-sidewalk vault, (ii) Any servicing (including rebuild- lower secondary voltage network PCB ing) of PCB Transformers (as defined in Transformer in or near a commercial the definition of ‘‘PCB Transformer’’ building, if electrical protective equip- under § 761.3) that requires the removal ment is not installed, within 18 months of the transformer coil from the trans- of discovery or by October 1, 1993, former casing is prohibited. PCB whichever is later. Transformers may be serviced (includ- (G) Remove a lower secondary volt- ing topping off) with dielectric fluid at age network PCB Transformer located any PCB concentration. in a sidewalk vault in or near a com- (iii) PCBs removed during any serv- mercial building, within 18 months of icing activity must be captured and ei- discovery or by October 1, 1993, which- ther reused as dielectric fluid or dis- ever is later. (H) Retrofill and reclassify a radial posed of in accordance with the re- PCB Transformer or a lower or higher quirements of § 761.60. PCBs from PCB secondary voltage network PCB Trans- Transformers must not be mixed with former, located in other than a side- or added to dielectric fluid from PCB- walk vault in or near a commercial Contaminated Electrical Equipment. building, within 18 months or by Octo- (iv) Regardless of its PCB concentra- ber 1, 1990, whichever is later. This is tion, dielectric fluids containing less an option in lieu of installing electrical than 500 ppm PCB that are mixed with protective equipment on a radial or fluids that contain 500 ppm or greater lower secondary voltage network PCB PCB must not be used as dielectric Transformer located in other than a fluid in any electrical equipment. The sidewalk vault or of removing a higher entire mixture of dielectric fluid must secondary voltage network PCB Trans- be considered to be greater than 500 former or a lower secondary voltage ppm PCB and must be disposed of in an network PCB Transformer, located in a incinerator that meets the require- sidewalk vault, from service. ments in § 761.70. (I) Retrofill and reclassify a lower (v) You may reclassify a PCB Trans- secondary voltage network PCB Trans- former that has been tested and deter- former, located in a sidewalk vault, in mined to have a concentration of ≥500 or near a commercial building within ppm PCBs to a PCB-Contaminated 18 months or by October 1, 1993, which- transformer (≥50 but < 500 ppm) or to a ever is later. This is an option in lieu non-PCB transformer (< 50 ppm), and of installing electrical protective you may reclassify a PCB-Contami- equipment or removing the trans- nated transformer that has been tested former from service. and determined to have a concentra- (J) Retrofill and reclassify a higher ≥ secondary voltage network PCB Trans- tion of 50 ppm but < 500 ppm to a non- former, located in a sidewalk vault, in PCB transformer, as follows: or near a commercial building within (A) Remove the free-flowing PCB di- 18 months or by October 1, 1990, which- electric fluid from the transformer. ever is later. This is an option in lieu Flushing is not required. Either test of other requirements. the fluid or assume it contains ≥1,000 (2) Servicing conditions. (i) Trans- ppm PCBs. Retrofill the transformer formers classified as PCB-Contami- with fluid containing known PCB lev- nated Electrical Equipment (as defined els according to the following table. in the definition of ‘‘PCB-Contami- Determine the transformer’s reclassi- nated Electrical Equipment’’ under fied status according to the following § 761.3) may be serviced (including re- table (if following this process does not building) only with dielectric fluid con- result in the reclassified status you de- taining less than 500 ppm PCB. sire, you may repeat the process):

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If test results show the and test results show PCB concentration and you retrofill the the PCB concentration then the transformer’s (ppm) in the transformer transformer with dielec- and you . . . (ppm) after retrofill is . . reclassified status is. . . prior to retrofill is . . . tric fluid containing . . . .

≥1,000 (or untested) < 50 ppm PCBs operate the transformer ≥50 but < 500 PCB-contaminated electrically under loaded conditions for at least 90-continuous days after retrofill, then test the fluid for PCBs

< 50 ppm PCBs operate the transformer <50 non-PCB electrically under loaded conditions for at least 90-continuous days after retrofill, then test the fluid for PCBs

≥500 but <1,000 <50 ppm PCBs test the fluid for PCBs ≥50 but <500 PCB-contaminated at least 90 days after retrofill

<50 ppm PCBs test the fluid for PCBs <50 non-PCB at least 90 days after retrofill

≥50 but <500 ≥2 but <50 ppm PCBs test the fluid for PCBs <50 non-PCB at least 90 days after retrofill

<2 ppm PCBs (no need to test) (not applicable) non-PCB

(B) If you discover that the PCB con- Pennsylvania Ave., NW., Washington, centration of the fluid in a reclassified DC 20460. Describe the equipment you transformer has changed, causing the plan to reclassify, the alternative re- reclassified status to change, the trans- classification method you plan to use, former is regulated based on the actual and test data or other evidence on the concentration of the fluid. For exam- effectiveness of the method. ple, a transformer that was reclassified (D) You must keep records of the re- to non-PCB status is regulated as a classification required by § 761.180(g). PCB-Contaminated transformer if you (vi) Any dielectric fluid containing 50 discover that the concentration of the ppm or greater PCB used for servicing ≥ fluid has increased to 50 but <500 ppm transformers must be stored in accord- PCBs. If you discover that the PCB ance with the storage for disposal re- concentration of the fluid has risen to quirements of § 761.65. ≥ 500 ppm, the transformer is regulated (vii) Processing and distribution in as a PCB Transformer. Follow para- commerce of PCBs for purposes of serv- graphs (a)(1)(xv)(A) through (J) of this icing transformers is permitted only section to come into compliance with for persons who are granted an exemp- the regulations applicable to PCB tion under TSCA 6(e)(3)(B). Transformers. You also have the option of repeating the reclassification proc- (b) Use in and servicing of railroad ess. transformers. PCBs may be used in (C) The Director, National Program transformers in railroad locomotives or Chemicals Division, may, without fur- railroad self-propelled cars (‘‘railroad ther rulemaking, grant approval on a transformers’’) and may be processed case-by-case basis for the use of alter- and distributed in commerce for pur- native methods to reclassify trans- poses of servicing these transformers in formers. You may request an approval a manner other than a totally enclosed by writing to the Director, National manner subject to the following condi- Program Chemicals Division (7404), En- tions: vironmental Protection Agency, 1200

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(1) Use restrictions. After July 1, 1986, maintain a concentration level of <50 use of railroad transformers that con- ppm PCBs. Heat transfer systems may tain dielectric fluids with a PCB con- only be serviced with fluids containing centration >1,000 ppm is prohibited. <50 ppm PCBs. (2) Servicing restrictions. (i) If the coil (e) Use in hydraulic systems. After is removed from the casing of a rail- July 1, 1984, PCBs may be used in hy- road transformer (e.g., the transformer draulic systems only at a concentra- is rebuilt), after January 1, 1982, the tion level of <50 ppm. Hydraulic sys- railroad transformer may not be re- tems that were in operation after July filled with dielectric fluid containing a 1, 1984, with a concentration level of PCB concentration greater than 50 <50 ppm PCBs may be serviced to main- ppm; tain a concentration level of <50 ppm (ii) After January 1, 1984, railroad PCBs. Hydraulic systems may only be transformers may only be serviced serviced with fluids containing <50 ppm with dielectric fluid containing less PCBs. than 1000 ppm PCB, except as provided (f) Use in carbonless copy paper. in paragraph (b)(2)(i) of this section; Carbonless copy paper containing PCBs (iii) Dielectric fluid may be filtered may be used in a manner other than a through activated carbon or otherwise totally enclosed manner indefinitely. industrially processed for the purpose (g) [Reserved] of reducing the PCB concentration in (h) Use in and servicing of the fluid; electromagnets, switches and voltage reg- (iv) Any PCB dielectric fluid that is ulators. PCBs at any concentration used to service PCB railroad trans- may be used in electromagnets, switch- formers must be stored in accordance es (including sectionalizers and motor with the storage for disposal require- starters), and voltage regulators and ments of § 761.65; may be used for purposes of servicing (v) After July 1, 1979, processing and this equipment (including rebuilding) distribution in commerce of PCBs for for the remainder of their useful lives, purposes of servicing railroad trans- subject to the following conditions: formers is permitted only for persons (1) Use conditions. (i) After October 1, who are granted an exemption under 1985, the use and storage for reuse of TSCA section 6(e)(3)(B). any electromagnet which poses an ex- (vi) A PCB Transformer may be con- posure risk to food or feed is prohibited verted to a PCB-Contaminated Trans- if the electromagnet contains greater former or to a non-PCB Transformer by than 500 ppm PCBs. draining, refilling, and/or otherwise (ii) Use and storage for reuse of volt- servicing the railroad transformer. In age regulators which contain 1.36 kilo- order to reclassify, the railroad trans- grams (3 lbs) or more of dielectric fluid former’s dielectric fluid must contain with a PCB concentration of ≥500 ppm less than 500 ppm (for conversion to are subject to the following provisions: PCB-Contaminated Transformer) or (A) The owner of the voltage regu- less than 50 ppm PCB (for conversion to lator must mark its location in accord- a non-PCB Transformer) after a min- ance with § 761.40. imum of three months of inservice use (B) If a voltage regulator is involved subsequent to the last servicing con- in a fire-related incident, the owner ducted for the purpose of reducing the must immediately report the incident PCB concentration in the transformer. to the National Response Center (Toll- (c) Use in mining equipment. After free: 1–800–424–8802; in Washington, DC: January 1, 1982, PCBs may be used in 202–426–2675). A fire-related incident is mining equipment only at a concentra- defined as any incident that involves tion level of <50 ppm. the generation of sufficient heat and/or (d) Use in heat transfer systems. After pressure, by any source, to result in July 1, 1984, PCBs may be used in heat the violent or non-violent rupture of transfer systems only at a concentra- the voltage regulator and the release of tion level of < 50 ppm. Heat transfer PCBs. systems that were in operation after (C) The owner of the voltage regu- July 1, 1984, with a concentration level lator must inspect it in accordance of <50 ppm PCBs may be serviced to with the requirements of paragraphs

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(a)(1)(ix), (a)(1)(xiii), and (a)(1)(xiv) of PCB-Contaminated Electrical Equip- this section that apply to PCB Trans- ment. formers. (iv) Regardless of its PCB concentra- (D) The owner of the voltage regu- tion, dielectric fluids containing less lator must comply with the record- than 500 ppm PCB that are mixed with keeping and reporting requirements at fluids that contain 500 ppm or greater § 761.180. PCB must not be used as dielectric (iii) The owner of a voltage regulator fluid in any electrical equipment. The that assumes it contains <500 ppm entire mixture of dielectric fluid must PCBs as provided in § 761.2, and dis- be considered to be greater than 500 covers by testing that it is contami- ppm PCB and must be disposed of in an ≥ nated at 500 ppm PCBs, must comply incinerator that meets the require- with paragraph (h)(1)(ii)(A) of this sec- ments of § 761.70. tion 7 days after the discovery, and (v) You may reclassify an electro- paragraphs (h)(1)(ii)(B), (h)(1)(ii)(C), magnet, switch, or voltage regulator and (h)(1)(ii)(D) of this section imme- that has been tested and determined to diately upon discovery. have a concentration of ≥500 ppm PCBs (2) Servicing conditions. (i) Servicing ≥ (including rebuilding) any electro- to PCB-Contaminated status ( 50 but magnet, switch, or voltage regulator <500 ppm) or to non-PCB status (<50 with a PCB concentration of 500 ppm or ppm), and you may reclassify a PCB- greater which requires the removal and Contaminated electromagnet, switch, rework of the internal components is or voltage regulator that has been test- prohibited. ed and determined to have a concentra- (ii) Electromagnets, switches, and tion of ≥50 ppm but <500 ppm to a non- voltage regulators classified as PCB- PCB status, as follows: Contaminated Electrical Equipment (A) Remove the free-flowing PCB di- (as defined in the definition of ‘‘PCB- electric fluid from the electromagnet, Contaminated Electrical Equipment’’ switch, or voltage regulator. Flushing under § 761.3) may be serviced (includ- is not required. Either test the fluid or ing rebuilding) only with dielectric assume it contains ≥1,000 ppm PCBs. fluid containing less than 500 ppm PCB. Retrofill the electromagnet, switch, or (iii) PCBs removed during any serv- voltage regulator with fluid containing icing activity must be captured and ei- known PCB levels according to the fol- ther reused as dielectric fluid or dis- lowing table. Determine the electro- posed of in accordance with the re- magnet, switch, or voltage regulator’s quirements of § 761.60. PCBs from reclassified status according to the fol- electromagnets switches, and voltage lowing table (if following this process regulators with a PCB concentration of does not result in the reclassified sta- at least 500 ppm must not be mixed tus you desire, you may repeat the with or added to dielectric fluid from process):

If test results show the and test results show then the electromagnet, PCB concentration and you retrofill the the PCB concentration switch, or voltage regu- (ppm) in the equipment equipment with dielec- and you . . . (ppm) after retrofill is . . lator’s reclassified sta- prior to retrofill is . . . tric fluid containing . . . . tus is . . .

≥1,000 (or untested) <50 ppm PCBs operate the equipment ≥50 but <500 PCB-contaminated electrically under loaded conditions for at least 90-continuous days after retrofill, then test the fluid for PCBs

<50 ppm PCBs operate the equipment <50 non-PCB electrically under loaded conditions for at least 90-continuous days after retrofill, then test the fluid for PCBs

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≥500 but <1,000 <50 ppm PCBs test the fluid for PCBs ≥50 but <500 PCB-contaminated at least 90 days after retrofill

<50 ppm PCBs test the fluid for PCBs <50 non-PCB at least 90 days after retrofill

≥50 but <500 ≥2 but <50 ppm PCBs test the fluid for PCBs <50 non-PCB at least 90 days after retrofill

<2 ppm PCBs (no need to test) (not applicable) non-PCB

(B) If you discover that the PCB con- (vi) Any dielectric fluid containing 50 centration of the fluid in a reclassified ppm or greater PCB used for servicing electromagnet, switch, or voltage regu- electromagnets, switches, or voltage lator has changed, causing the reclassi- regulators must be stored in accord- fied status to change, the electro- ance with the storage for disposal re- magnet, switch, or voltage regulator is quirements of § 761.65. regulated based on the actual con- (vii) Processing and distribution in centration of the fluid. For example, an commerce of PCBs for purposes of serv- electromagnet, switch, or voltage regu- icing electromagnets, switches or volt- lator that was reclassified to non-PCB age regulators is permitted only for status is regulated as a PCB-Contami- persons who are granted an exemption nated electromagnet, switch, or volt- under TSCA 6(e)(3)(B). age regulator if you discover that the (i) Use and reuse of PCBs in natural concentration of the fluid has in- gas pipeline systems; use and reuse of creased to ≥50 but <500 ppm PCBs. If PCB-Contaminated natural gas pipe and you discover that the PCB concentra- appurtenances. (1)(i) PCBs are author- tion of the fluid in a voltage regulator ized for use in natural gas pipeline sys- has risen to ≥500 ppm, follow paragraph tems at concentrations <50 ppm. (h)(1)(iii) of this section to come into (ii) PCBs are authorized for use, at compliance with the regulations appli- concentrations ≥50 ppm, in natural gas cable to voltage regulators containing pipeline systems not owned or operated ≥500 ppm PCBs. You also have the op- by a seller or distributor of natural tion of repeating the reclassification gas. process. (iii)(A) PCBs are authorized for use, (C) The Director, National Program at concentrations ≥50 ppm, in natural Chemicals Division may, without fur- gas pipeline systems owned or operated ther rulemaking, grant approval on a by a seller or distributor of natural case-by-case basis for the use of alter- gas, if the owner or operator: native methods to reclassify (1) Submits to EPA, upon request, a electromagnets, switches or voltage written description of the general na- regulators. You may request an ap- ture and location of PCBs ≥50 ppm in proval by writing to the Director, Na- their natural gas pipeline system. Each tional Program Chemicals Division written description shall be submitted (7404), Environmental Protection Agen- to the EPA Regional Administrator cy,1200 Pennsylvania Ave., NW., Wash- having jurisdiction over the segment or ington, DC 20460. Describe the equip- component of the system (or the Direc- ment you plan to reclassify, the alter- tor, National Program Chemicals Divi- native reclassification method you sion, Office of Prevention, Pesticides, plan to use, and test data or other evi- and Toxic Substances, if the system is dence on the effectiveness of the meth- contaminated in more than one re- od. gion). (D) You must keep records of the re- (2) Within 120 days after discovery of classification required by § 761.180(g). PCBs ≥50 ppm in natural gas pipeline

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systems, or by December 28, 1998, must comply with the other provisions whichever is later, characterizes the of this section (e.g., sampling of any extent of PCB contamination by col- collected PCB liquids and record- lecting and analyzing samples to iden- keeping). tify the upstream and downstream end (C) The owner or operator of a nat- points of the segment or component ural gas pipeline system must docu- where PCBs ≥50 ppm were discovered. ment in writing all data collected and (3) Within 120 days of characteriza- actions taken, or not taken, pursuant tion of the extent of PCB contamina- to the authorization in paragraph tion, or by December 28, 1998, which- (i)(1)(iii)(A) of this section. They must ever is later, samples and analyzes all maintain the information for 3 years potential sources of introduction of after the PCB concentration in the PCBs into the natural gas pipeline sys- component or segment is reduced to ≥ tem for PCBs 50 ppm. Potential <50 ppm, and make it available to EPA sources include natural gas compres- upon request. sors, natural gas scrubbers, natural gas (D) The Director, National Program filters, and interconnects where nat- Chemicals Division, after consulting ural gas is received upstream from the with the appropriate EPA Region(s) most downstream sampling point may, based on a finding of no unreason- where PCBs ≥50 ppm were detected; po- able risk, modify in writing the re- tential sources exclude valves, drips, or quirements of paragraph (i)(1)(iii)(A) of other small liquid condensate collec- this section, including extending any tion points. compliance date, approving alternative (4) Within 1 year of characterization formats for documentation, waiving of the extent of PCB contamination, reduces all demonstrated sources of one or more requirements for a seg- PCBs ≥50 ppm to <50 ppm, or removes ment or component, requiring sam- such sources from the natural gas pipe- pling and analysis, and requiring im- line system; or implements other engi- plementation of engineering measures neering measures or methods to reduce to reduce PCB concentrations. EPA PCB levels to <50 ppm and to prevent will make such modifications based on further introduction of PCBs ≥50 ppm the natural gas pipeline system size, into the natural gas pipeline system configuration, and current operating (e.g., pigging, decontamination, in-line conditions; nature, extent or source of filtration). contamination; proximity of contami- (5) Repeats sampling and analysis at nation to end-users; or previous sam- least annually where PCBs are ≥50 ppm, pling, monitoring, remedial actions or until sampling results indicate the nat- documentation of activities taken re- ural gas pipeline segment or compo- garding compliance with this author- nent is <50 ppm PCB in two successive ization or other applicable Federal, samples with a minimum interval be- State, or local laws and regulations. tween samples of 180 days. The Director, National Program (6) Marks aboveground sources of Chemicals Division, may defer the au- PCB liquids in natural gas pipeline sys- thority described in this paragraph, upon request, to the appropriate EPA tems with the ML Mark in accordance with § 761.45(a), where such sources Region. have been demonstrated through his- (E) The owner or operator of a nat- torical data or recent sampling to con- ural gas pipeline system may use his- tain PCBs ≥50 ppm. torical data to fulfill the requirements (B) Owners or operators of natural of paragraphs (i)(1)(iii)(A)(1), gas pipeline systems which do not in- (i)(1)(iii)(A)(2) and (i)(1)(iii)(A)(3) of clude potential sources of PCB con- this section. They may use documented tamination as described in paragraph historical actions taken to reduce PCB (i)(1)(iii)(A)(3) of this section con- concentrations in known sources; de- taining ≥50 ppm PCB are not subject to contaminate components or segments paragraphs (i)(1)(iii)(A)(2), of natural gas pipeline systems; or oth- (i)(1)(iii)(A)(3), (i)(1)(iii)(A)(4), or erwise to reduce PCB levels to fulfill (i)(1)(iii)(A)(6) of this section. Owners the requirements of paragraph or operators of these systems, however, (i)(1)(iii)(A)(4) of this section.

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(2) Any person may reuse PCB-Con- other use of liquid containing PCBs at taminated natural gas pipe and appur- concentrations above the quantifiable tenances in a natural gas pipeline sys- level/level of detection removed from a tem, provided all free-flowing liquids natural gas pipeline system is author- have been removed. ized. (3) Any person may use PCB-Con- (j) Research and development. For pur- taminated natural gas pipe, drained of poses of this section, authorized re- all free-flowing liquids, in the trans- search and development (R&D) activi- port of liquids (e.g., bulk hydrocarbons, ties include, but are not limited to: the chemicals, petroleum products, or coal chemical analysis of PCBs, including slurry), as casing to provide secondary analyses to determine PCB concentra- containment or protection (e.g., pro- tion; determinations of the physical tection for electrical cable), as indus- properties of PCBs; studies of environ- trial structural material (e.g., fence mental transport processes; studies of posts, sign posts, or bridge supports), biochemical transport processes; stud- as temporary flume at construction ies of effects of PCBs on the environ- sites, as equipment skids, as culverts ment; and studies of the health effects under transportation systems in inter- of PCBs, including direct toxicity and mittent flow situations, for sewage toxicity of metabolic products of PCBs. service with written consent of the Authorized R&D activities do not in- Publicly Owned Treatment Works clude research, development, or anal- (POTW), for steam service, as irriga- ysis for the development of any PCB tion systems (<20 inch diameter) of less product. Any person conducting R&D than 200 miles in length, and in a to- activities under this section is also re- tally enclosed compressed air system. sponsible for determining and com- (4) Any person characterizing PCB plying with all other applicable Fed- contamination in natural gas pipe or eral, State, and local laws and regula- natural gas pipeline systems must do tions. Although the use of PCBs and so by analyzing organic liquids col- PCBs in analytical reference samples lected at existing condensate collec- derived from waste material is author- tion points in the pipe or pipeline sys- ized in conjunction with PCB-disposal tem. The level of PCB contamination related activities, R&D for PCB dis- found at a collection point is assumed posal (as defined under § 761.3) is ad- to extend to the next collection point dressed in § 761.60(j). PCBs and PCBs in downstream. Any person character- analytical reference samples derived izing multi-phasic liquids must do so in from waste materials are authorized accordance with § 761.1(b)(4); if no liq- for use, in a manner other than a to- uids are present, they must use stand- tally enclosed manner, provided that: ard wipe samples in accordance with subpart M of this part. (1) They obtain the PCBs and PCBs in (5)(i) Any person disposing of liquids analytical reference samples derived containing PCBs ≥50 ppm removed, from waste materials from sources au- spilled, or otherwise released from a thorized under § 761.80 to manufacture, natural gas pipeline system must do so process, and distribute PCBs in com- in accordance with § 761.61(a)(5)(iv) merce and the PCBs are packaged in based on the PCB concentration at the compliance with the Hazardous Mate- time of removal from the system. Any rials Regulations at 49 CFR parts 171 person disposing of materials contami- through 180. nated by spills or other releases of (2) They store all PCB wastes result- PCBs ≥50 ppm from a natural gas pipe- ing from R&D activities (e.g., spent line systems, must do so in accordance laboratory samples, residuals, con- with §§ 761.61 or 761.79, as applicable. taminated media such as clothing, etc.) (ii) Any person who markets or burns in compliance with § 761.65(b) and dis- for energy recovery liquids containing pose of all PCB wastes in compliance PCBs at concentrations <50 ppm PCBs with § 761.64. at the time of removal from a natural (3) [Reserved] gas pipeline system must do so in ac- (4) No person may manufacture, proc- cordance with the provisions per- ess, or distribute in commerce PCBs for taining to used oil at § 761.20(e). No research and development unless they

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have been granted an exemption to do (ii) Any circuit breaker, recloser or so under TSCA section 6(e)(3)(B). cable found to contain at least 50 ppm (k) Use in scientific instruments. PCBs PCBs may be serviced only in accord- may be used indefinitely in scientific ance with the conditions contained in instruments, for example, in oscilla- 40 CFR 761.30(h)(2). tory flow birefringence and (2) [Reserved] viscoelasticity instruments for the (n)–(o) [Reserved] study of the physical properties of (p) Continued use of porous surfaces polymers, as microscopy mounting contaminated with PCBs regulated for fluids, as microscopy immersion oil, disposal by spills of liquid PCBs. (1) Any and as optical liquids in a manner person may use porous surfaces con- other than a totally enclosed manner. taminated by spills of liquid PCBs at No person may manufacture, process, concentrations >10 μg/100 cm2 for the or distribute in commerce PCBs for use remainder of the useful life of the sur- in scientific instruments unless they faces and subsurface material if the have been granted an exemption to do following conditions are met: so under TSCA section 6(e)(3)(B). (i) The source of PCB contamination (l) Use in capacitors. PCBs at any con- is removed or contained to prevent fur- centration may be used in capacitors, ther release to porous surfaces. subject to the following conditions: (ii) If the porous surface is accessible (1) Use conditions. (i) After October 1, to superficial surface cleaning: 1988, the use and storage for reuse of (A) The double wash rinse procedure PCB Large High Voltage Capacitors in subpart S of this part is conducted and PCB Large Low Voltage Capacitors on the surface to remove surface PCBs. which pose an exposure risk to food or (B) The treated surface is allowed to feed is prohibited. dry for 24 hours. (ii) After October 1, 1988, the use of (iii) After accessible surfaces have PCB Large High Voltage Capacitors been cleaned according to paragraph and PCB Large Low Voltage Capacitors (p)(1)(ii) of this section and for all sur- is prohibited unless the capacitor is faces inaccessible to cleanup: used within a restricted-access electrical substation or in a contained and (A) The surface is completely covered restricted-access indoor installation. A to prevent release of PCBs with: restricted-access electrical substation (1) Two solvent resistant and water is an outdoor, fenced or walled-in facil- repellent coatings of contrasting colors ity that restricts public access and is to allow for a visual indication of wear used in the transmission or distribu- through or loss of outer coating integ- tion of electric power. A contained and rity; or restricted-access indoor installation (2) A solid barrier fastened to the sur- does not have public access and has an face and covering the contaminated adequate roof, walls, and floor to con- area or all accessible parts of the contain any release of PCBs within the in- taminated area. Examples of inacces- door location. sible areas are underneath a floor- (2) [Reserved] mounted electrical transformer and in (m) Use in and servicing of circuit an impassible space between an elec- breakers, reclosers and cable. PCBs at trical transformer and a vault wall. any concentration may be used in cir- (B) The surface is marked with the cuit breakers, reclosers, and cable and ML Mark in a location easily visible to may be used for purposes of servicing individuals present in the area; the ML this electrical equipment (including re- Mark shall be placed over the encap- building) for the remainder of their sulated area or the barrier to the en- useful lives, subject to the following capsulated area. conditions: (C) ML Marks shall be replaced when (1) Servicing conditions. (i) Circuit worn or illegible. breakers, reclosers, and cable may be (2) Removal of a porous surface con- serviced (including rebuilding) only taminated with PCBs from its location with dielectric fluid containing less or current use is prohibited except for than 50 ppm PCB. removal for disposal in accordance

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with §§ 761.61 or 761.79 for surfaces con- applicable to natural gas pipeline sys- taminated by spills, or § 761.62 for man- tems at paragraphs (i)(1)(iii)(A), ufactured porous surfaces. (i)(1)(iii)(C) through (i)(1)(iii)(E), and (q) [Reserved] (i)(2) through (i)(5) of this section. (r) Use in and servicing of rectifiers. (u) Use of decontaminated materials. (1) Any person may use PCBs at any con- Any person may use equipment, struc- centration in rectifiers for the remain- tures, other non-liquid or liquid mate- der of the PCBs’ useful life, and may rials that were contaminated with use PCBs <50 ppm in servicing (includ- PCBs during manufacture, use, serving rebuilding) rectifiers. icing, or because of spills from, or prox- (s) Use of PCBs in air compressor sys- imity to, PCBs ≥50 ppm, including tems. (1) Any person may use PCBs in those not otherwise authorized for use air compressor systems at concentra- under this part, provided: tions <50 ppm. (i) The materials were decontami- (2) Any person may use PCBs in air nated in accordance with: compressor systems (or components (A) A TSCA PCB disposal approval thereof) at concentrations ≥50 ppm pro- issued under subpart D of this part; vided that: (B) Section 761.79; or (i) All free-flowing liquids containing (C) Applicable EPA PCB spill cleanup PCBs ≥50 ppm are removed from the air policies (e.g., TSCA, RCRA, CERCLA, compressor crankcase and the crank- EPA regional) in effect at the time of case is refilled with non-PCB liquid. the decontamination; or (ii) Other air compressor system (ii) If not previously decontaminated, components contaminated with PCBs the materials now meet an applicable ≥50 ppm, are decontaminated in accord- decontamination standard in § 761.79(b). ance with § 761.79 or disposed of in ac- (2) No person shall use or reuse mate- cordance with subpart D of this part. rials decontaminated in accordance (iii) Air compressor piping with a with paragraph (u)(1)(i) of this section nominal inside diameter of <2 inches is or meeting an applicable decontamina- decontaminated by continuous flushing tion standard in paragraph (u)(1)(ii) of for 4 hours, at no <300 gallons per hour this section, in direct contact with (§ 761.79 contains solvent requirements). food, feed, or drinking water unless (3) The requirements in paragraph otherwise allowed under this section or (s)(2) of this section must be completed this part. (3) Any person may use water con- by August 30, 1999 or within 1 year of ≤ μ the date of discovery of PCBs at ≥50 taining PCBs at concentrations 0.5 g/ ppm in the air compressor system, L PCBs without restriction. (4) Any person may use water con- whichever is later. The EPA Regional taining PCBs at concentrations <200 μg/ Administrator for the EPA Region in L (i.e., < 200 ppb PCBs) for non-contact which an air compressor system is lo- use in a closed system where there are cated may, at his/her discretion and in no releases (e.g., as a non-contact cool- writing, extend this timeframe. ing water). (t) Use of PCBs in other gas or liquid transmission systems. (1) PCBs are au- (Sec. 6, Pub. L. 94–469, 90 Stat. 2020, 2025 (15 thorized for use in intact and non-leak- U.S.C. 2605) ing gas or liquid transmission systems [44 FR 31542, May 31, 1979. Redesignated at 47 at concentrations <50 ppm PCBs. FR 19527, May 6, 1982] (2) PCBs are authorized for use at EDITORIAL NOTE: For FEDERAL REGISTER ci- concentrations ≥50 ppm in intact and tations affection § 761.30 see the List of CFR non-leaking gas or liquid transmission Sections Affected, which appears in the systems not owned or operated by a Finding Aids section of the printed volume seller or distributor of the gas or liquid and at www.fdsys.gov. transmitted in the system. (3) Any person may use PCBs at con- § 761.35 Storage for reuse. centrations ≥50 ppm in intact and non- (a) The owner or operator of a PCB leaking gas or liquid transmission sys- Article may store it for reuse in an tems, with the written approval of the area which is not designed, con- Director, National Program Chemicals structed, and operated in compliance Division, subject to the requirements with § 761.65(b), for no more than 5

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years after the date the Article was Subpart C—Marking of PCBs and originally removed from use (e.g., dis- PCB Items connected electrical equipment) or 5 years after August 28, 1998, whichever § 761.40 Marking requirements. is later, if the owner or operator com- (a) Each of the following items in ex- plies with the following conditions: istence on or after July 1, 1978 shall be (1) Follows all use requirements at marked as illustrated in Figure 1 in § 761.30 and marking requirements at § 761.45(a): The mark illustrated in Fig- subpart C of this part that are applica- ure 1 is referred to as M throughout ble to the PCB Article. L this subpart. (2) Maintains records starting at the (1) PCB Containers; time the PCB Article is removed from (2) PCB Transformers at the time of use or August 28, 1998. The records manufacture, at the time of distribu- must indicate: tion in commerce if not already (i) The date the PCB Article was re- marked, and at the time of removal moved from use or August 28, 1998, if from use if not already marked. [Mark- the removal date is not known. ing of PCB-Contaminated Electrical (ii) The projected location and the fu- Equipment is not required]; ture use of the PCB Article. (3) PCB Large High Voltage Capaci- (iii) If applicable, the date the PCB tors at the time of manufacture, at the Article is scheduled for repair or serv- time of distribution in commerce if not icing. already marked, and at the time of re- (b) The owner or operator of a PCB moval from use if not already marked; Article may store it for reuse in an (4) Equipment containing a PCB area that does not comply with Transformer or a PCB Large High Volt- § 761.65(b) for a period longer than 5 age Capacitor at the time of manufac- years, provided that the owner or oper- ture, at the time of distribution in ator has received written approval commerce if not already marked, and from the EPA Regional Administrator at the time of removal of the equip- for the Region in which the PCB Arti- ment from use if not already marked; cle is stored. An owner or operator of a (5) PCB Large Low Voltage Capaci- PCB Article seeking approval to extend tors at the time of removal from use the 5–year period must submit a re- (see also paragraph (k) of this section). quest for extension to the EPA Re- (6) Electric motors using PCB cool- gional Administrator at least 6 months ants (See also paragraph (e) of this sec- before the 5-year storage for reuse pe- tion). riod expires and must include an item- (7) Hydraulic systems using PCB hy- by-item justification for the desired ex- draulic fluid (See also paragraph (e) of tension. The EPA Regional Adminis- this section); trator may include any conditions to (8) Heat transfer systems (other than such approval deemed necessary to pro- PCB Transformers) using PCBs (See tect health or the environment. The also paragraph (e) of this section); owner or operator of the PCB Article being stored for reuse must comply (9) PCB Article Containers con- with the other applicable provisions of taining articles or equipment that this part, including the record reten- must be marked under paragraphs (a) tion requirements at § 761.180(a). (1) through (8) of this section; (10) Each storage area used to store (c) Any person may store a PCB Arti- PCBs and PCB Items for disposal. cle for reuse indefinitely in: (b) As of October 1, 1978, each trans- (1) A unit in compliance with port vehicle loaded with PCB Con- § 761.65(b). tainers that contain more than 45 kg (2) A unit permitted under section (99.4 lbs.) of liquid PCBs at concentra- 3004 of RCRA to manage hazardous tions of ≥50 ppm or with one or more wastes in containers. PCB Transformers shall be marked on (3) A unit permitted by a State au- each end and each side with the M thorized under section 3006 of RCRA to L mark as described in § 761.45(a). manage hazardous waste. (c) As of January 1, 1979, the fol- [63 FR 35443, June 29, 1998] lowing PCB Articles shall be marked

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with mark ML as described in the exterior of the PCB Items, storage § 761.45(a): units, or transport vehicles so that the (1) All PCB Transformers not marked marks can be easily read by any per- under paragraph (a) of this section sons inspecting or servicing the [marking of PCB-Contaminated Elec- marked PCB Items, storage units, or trical Equipment is not required]; transport vehicles. (2) All PCB Large High Voltage Ca- (i) Any chemical substance or mix- pacitors not marked under paragraph ture that is manufactured after the ef- (a) of this section fective date of this rule and that con- (i) Will be marked individually with tains less than 500 ppm PCB (0.05% on mark ML, or a dry weight basis), including PCB that (ii) If one or more PCB Large High is a byproduct or impurity, must be Voltage Capacitors are installed in a marked in accordance with any re- protected location such as on a power quirements contained in the exemption pole, or structure, or behind a fence; granted by EPA to permit such manu- the pole, structure, or fence shall be facture and is not subject to any other marked with mark ML, and a record or requirement in this subpart unless so procedure identifying the PCB Capaci- specified in the exemption. This para- tors shall be maintained by the owner graph applies only to containers of or operator at the protected location. chemical substances or mixtures. PCB (d) As of January 1, 1979, all PCB articles and equipment into which the Equipment containing a PCB Small Ca- chemical substances or mixtures are pacitor shall be marked at the time of processed, are subject to the marking manufacture with the statement, ‘‘This requirements contained elsewhere in equipment contains PCB Capacitor(s)’’. this subpart. The mark shall be of the same size as (j) PCB Transformer locations shall the mark M . L be marked as follows: (e) As of October 1, 1979, applicable (1) Except as provided in paragraph PCB Items in paragraphs (a)(1), (a)(6), (j)(2) of this section, as of December 1, (a)(7), and (a)(8) of this section containing PCBs in concentrations of 50 to 1985, the vault door, machinery room door, fence, hallway, or means of ac- 500 ppm shall be marked with the ML mark as described in § 761.45(a). cess, other than grates and manhole covers, to a PCB Transformer must be (f) Where mark ML is specified but the PCB Article or PCB Equipment is marked with the mark ML as required too small to accomodate the smallest by paragraph (a) of this section. (2) A mark other than the ML mark permissible size of mark ML, mark MS as described in § 761.45(b), may be used may be used provided all of the following conditions are met: instead of mark ML. (g) Each large low voltage capacitor, (i) The program using such an alter- each small capacitor normally used in native mark was initiated prior to Au- alternating current circuits, and each gust 15, 1985, and can be substantiated fluorescent light ballast manufactured with documentation. (‘‘manufactured’’, for purposes of this (ii) Prior to August 15, 1985, coordina- sentence, means built) between July 1, tion between the transformer owner 1978 and July 1, 1998 that do not con- and the primary fire department oc- tain PCBs shall be marked by the man- curred, and the primary fire depart- ufacturer at the time of manufacture ment knows, accepts, and recognizes with the statement, ‘‘No PCBs’’. The what the alternative mark means, and mark shall be of similar durability and that this can be substantiated with readability as other marking that indi- documentation. cate electrical information, part num- (iii) The EPA Regional Adminis- bers, or the manufacturer’s name. For trator in the appropriate region is in- purposes of this paragraph marking reformed in writing of the use of the al- quirement only is applicable to items ternative mark by October 3, 1988 and built domestically or abroad after June is provided with documentation that 30, 1978. the program began before August 15, (h) All marks required by this sub- 1985, and documentation that dem- part must be placed in a position on onstrates that prior to that date the

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primary fire department knew, accept- manhole covers, must be marked with ed and recognized the meaning of the the ML mark as described in § 761.45(a). mark, and included this information in firefighting training. [44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, and amended at 47 FR (iv) The Regional Administrator will 37359, Aug. 25, 1982; 50 FR 29201, July 17, 1985; either approve or disapprove in writing 50 FR 32176, Aug. 9, 1985; 53 FR 12524, Apr. 15, the use of an alternative mark within 1988; 53 FR 27329, July 19, 1988; 63 FR 35443, 30 days of receipt of the documentation June 29, 1998; 64 FR 33760, June 24, 1999] of a program. (3) Any mark placed in accordance § 761.45 Marking formats. with the requirements of this section The following formats shall be used must be placed in the locations de- for marking: scribed in paragraph (j)(1) of this sec- (a) Large PCB Mark—ML. Mark ML tion and in a manner that can be easily shall be as shown in Figure 1, letters read by emergency response personnel and striping on a white or yellow back- fighting a fire involving this equip- ground and shall be sufficiently dura- ment. ble to equal or exceed the life (includ- (k) As of April 26, 1999 the following ing storage for disposal) of the PCB Ar- PCB Items shall be marked with the ticle, PCB Equipment, or PCB Con- M mark as described in § 761.45(a): L tainer. The size of the mark shall be at (1) All PCB Large Low Voltage Ca- least 15.25 cm (6 inches) on each side. If pacitors not marked under paragraph the PCB Article or PCB Equipment is (a) of this section shall be marked indi- too small to accommodate this size, vidually, or if one or more PCB Large Low Voltage Capacitors are installed the mark may be reduced in size pro- in a protected location such as on a portionately down to a minimum of 5 power pole, or structure, or behind a cm (2 inches) on each side. fence, then the owner or operator shall (b) Small PCB Mark—Ms. Mark Ms mark the pole, structure, or fence with shall be as shown in Figure 2, letters and striping on a white or yellow back- the ML mark, and maintain a record or procedure identifying the PCB Capaci- ground, and shall be sufficiently dura- tors at the protected location. PCB ble to equal or exceed the life (includ- Large Low Voltage Capacitors in inac- ing storage for disposal) of the PCB Ar- cessible locations inside equipment ticle, PCB Equipment, or PCB Con- need not be marked individually, pro- tainer. The mark shall be a rectangle vided the owner or operator marks the 2.5 by 5 cm (1 inch by 2 inches). If the equipment in accordance with para- PCB Article or PCB Equipment is too graph (k)(2) of this section, and marks small to accommodate this size, the the individual capacitors at the time of mark may be reduced in size propor- removal from use in accordance with tionately down to a minimum of 1 by 2 paragraph (a) of this section. cm (.4 by .8 inches). (2) All equipment not marked under paragraph (a) of this section containing a PCB Transformer or a PCB Large High or Low Voltage Capacitor. (l)(1) All voltage regulators which contain 1.36 kilograms (3 lbs.) or more of dielectric fluid with a PCB concentration of ≥ 500 ppm must be marked individually with the ML mark as described in § 761.45(a). (2) Locations of voltage regulators which contain 1.36 kilograms (3 lbs.) or more of dielectric fluid with a PCB concentration of ≥ 500 ppm shall be marked as follows: The vault door, machinery room door, fence, hallway, or means of access, other than grates or

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section 307(b) or 402 of the Clean Water Act. (4) Spills and other uncontrolled discharges of PCBs at concentrations of ≥50 ppm constitute the disposal of PCBs. (5) Any person land disposing of non- liquid PCBs may avoid otherwise-applicable sampling requirements by pre- suming that the PCBs disposed of are ≥500 ppm (or ≥100 μg/100 cm2 if no free- flowing liquids are present). (6) Any person storing or disposing of PCBs is also responsible for determining and complying with all other applicable Federal, State, and local laws and regulations. (b) PCB waste—(1) PCB liquids. Any person removing PCB liquids from use (i.e., not PCB remediation waste) must dispose of them in accordance with § 761.60(a), or decontaminate them in accordance with § 761.79. (2) PCB Items. Any person removing from use a PCB Item containing an intact and non-leaking PCB Article must dispose of it in accordance with § 761.60(b), or decontaminate it in accordance with § 761.79. PCB Items where the PCB Articles are no longer intact [44 FR 31542, May 31, 1979. Redesignated at 47 and non-leaking are regulated for dis- FR 19527, May 6, 1982] posal as PCB bulk product waste under § 761.62(a) or (c). Subpart D—Storage and Disposal (i) Fluorescent light ballasts containing PCBs only in an intact and § 761.50 Applicability. non-leaking PCB Small Capacitor are (a) General PCB disposal requirements. regulated for disposal under Any person storing or disposing of PCB § 761.60(b)(2)(ii). waste must do so in accordance with (ii) Fluorescent light ballasts con- subpart D of this part. The following taining PCBs in the potting material prohibitions and conditions apply to all are regulated for disposal as PCB bulk PCB waste storage and disposal: product waste under § 761.62. (1) No person may open burn PCBs. (3) PCB remediation waste. PCB reme- Combustion of PCBs approved under diation waste, including PCB sewage § 761.60 (a) or (e), or otherwise allowed sludge, is regulated for cleanup and dis- under part 761, is not open burning. posal in accordance with § 761.61. (2) No person may process liquid (i) Any person responsible for PCB PCBs into non-liquid forms to cir- waste at as-found concentrations ≥ 50 cumvent the high temperature inciner- ppm that was either placed in a land ation requirements of § 761.60(a). disposal facility, spilled, or otherwise (3) No person may discharge water released into the environment prior to containing PCBs to a treatment works April 18, 1978, regardless of the con- (as defined § 503.9(aa) of this chapter) or centration of the spill or release; or to navigable waters unless the PCB placed in a land disposal facility, concentration is <3 μg/L (approxi- spilled, or otherwise released into the mately 3 ppb), or unless the discharge environment on or after April 18, 1978, is in accordance with a PCB discharge but prior to July 2, 1979, where the con- limit included in a permit issued under centration of the spill or release was

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≥ 50 ppm but < 500 ppm, must dispose of after April 18, 1978, but prior to July 2, the waste as follows: 1979, where the concentration of the (A) Sites containing these wastes are spill or release was ≥ 500 ppm; or placed presumed not to present an unreason- in a land disposal facility, spilled, or able risk of injury to health or the en- otherwise released into the environ- vironment from exposure to PCBs at ment on or after July 2, 1979, where the the site. However, the EPA Regional concentration of the spill or release Administrator may inform the owner was ≥ 50 ppm, must dispose of it in ac- or operator of the site that there is cordance with either of the following: reason to believe that spills, leaks, or (A) In accordance with the PCB Spill other uncontrolled releases or dis- Cleanup Policy (Policy) at subpart G of charges, such as leaching, from the site this part, for those PCB remediation constitute ongoing disposal that may wastes that meet the criteria of the present an unreasonable risk of injury Policy. Consult the Policy for a de- to health or the environment from ex- scription of the spills it covers and its posure to PCBs at the site, and may re- notification and timing requirements. quire the owner or operator to generate (B) In accordance with § 761.61. Com- data necessary to characterize the risk. plete compliance with § 761.61 does not If after reviewing any such data, the create a presumption against enforce- EPA Regional Administrator makes a ment action for penalties for any unau- finding, that an unreasonable risk ex- thorized PCB disposal. ists, then he or she may direct the (iii) The owner or operator of a site owner or operator of the site to dispose containing PCB remediation waste has of the PCB remediation waste in ac- the burden of proving the date that the cordance with § 761.61 such that an un- waste was placed in a land disposal fa- reasonable risk of injury no longer ex- cility, spilled, or otherwise released ists. into the environment, and the con- (B) Unless directed by the EPA Re- centration of the original spill. gional Administrator to dispose of PCB (4) PCB bulk product waste—(i) Gen- waste in accordance with paragraph eral. Any person disposing of PCB bulk (b)(3)(i)(A) of this section, any person product waste must do so in accord- responsible for PCB waste at as-found ance with § 761.62. PCB bulk product concentrations ≥ 50 ppm that was either waste, as that term is defined in § 761.3, placed in a land disposal facility, is waste that was ≥50 ppm when origi- spilled, or otherwise released into the nally removed from service, even if its environment prior to April 18, 1978, recurrent PCB concentration is <50 ppm. gardless of the concentration of the PCB bulk product waste is regulated spill or release; or placed in a land dis- for disposal based on the risk from the posal facility, spilled, or otherwise re- waste once disposed of. For waste leased into the environment on or after which is land disposed, the waste is April 18, 1978, but prior to July 2, 1979, regulated based on how readily the where the concentration of the spill or waste is released from disposal to the release was ≥ 50 ppm but < 500 ppm, who environment, in particular by leaching unilaterally decides to dispose of that out from the land disposal unit. waste (for example, to obtain insurance (ii) Metal surfaces in contact with or to sell the property), is not required PCBs. Any person disposing of metal to clean up in accordance with § 761.61. surfaces in contact with PCBs (e.g., Disposal of the PCB remediation waste painted metal) may use thermal decon- must comply with § 761.61. However, tamination procedures in accordance cleanup of those wastes that is not in with § 761.79(c)(6) (see § 761.62(a)(6)). complete compliance with § 761.61 will (5) PCB household waste. Any person not afford the responsible party with storing or disposing of PCB household relief from the applicable PCB regula- waste, as that term is defined in § 761.3, tions for that waste. must do so in accordance with § 761.63. (ii) Any person responsible for PCB (6) PCB research and development waste at as-found concentrations ≥ 50 waste. Any person disposing of PCB ppm that was either placed in a land wastes generated during and as a result disposal facility, spilled, or otherwise of research and development for use released into the environment on or under § 761.30(j), or for disposal under

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§ 761.60(j), must do so in accordance (c) Storage for disposal. Any person with § 761.64. who holds PCB waste must store it in (7) PCB/Radioactive waste. (i) Any per- accordance with § 761.65. son storing PCB/radioactive waste ≥50 (d) Performance specifications for dis- ppm PCBs must do so taking into ac- posal technologies—(1) Incinerators. Any count both its PCB concentration and person using an incinerator to dispose its radioactive properties, except as of PCBs must use an incinerator that provided in § 761.65(a)(1), (b)(1)(ii), and meets the criteria set forth in § 761.70. (c)(6)(i). (2) High efficiency boilers. Any person (ii) Any person disposing of PCB/ra- using a high efficiency boiler to dispose dioactive waste must do so taking into of PCBs must use a boiler that meets account both its PCB concentration the criteria set forth in § 761.71. and its radioactive properties. If, taking into account only the properties of (3) Scrap metal recovery ovens and the PCBs in the waste (and not the ra- smelters. Any person using scrap metal dioactive properties of the waste), the recovery ovens and smelters to dispose waste meets the requirements for dis- of PCBs must use a device that meets posal in a facility permitted, licensed, the criteria set forth in § 761.72. or registered by a State as a municipal (4) Chemical waste landfills. Any per- or non-municipal non-hazardous waste son using a chemical waste landfill to landfill (e.g., PCB bulk product waste dispose of PCBs must use a chemical under § 761.62(b)(1)), then the person waste landfill that meets the criteria may dispose of the PCB/radioactive set forth in § 761.75. waste, without regard to the PCB com- (e) TSCA PCB Coordinated Approval. ponent of the waste, on the basis of its Any person seeking a TSCA PCB Co- radioactive properties in accordance ordinated Approval must follow the with all applicable requirements for procedures set forth in § 761.77. the radioactive component of the waste. [63 FR 35444, June 29, 1998, as amended at 64 (8) Porous surfaces. In most cases a FR 33760, June 24, 1999] person must dispose of porous surfaces § 761.60 Disposal requirements. as materials where PCBs have pene- trated far beneath the surface, rather (a) PCB liquids. PCB liquids at con- than a simple surface contamination. centrations ≥50 ppm must be disposed Any person disposing of porous sur- of in an incinerator which complies faces on which PCBs have been spilled with § 761.70, except that PCB liquids at and meeting the definition of PCB re- concentrations ≥50 ppm and <500 ppm mediation waste at § 761.3 must do so in may be disposed of as follows: accordance with § 761.61. Any person (1) For mineral oil dielectric fluid, in disposing of porous surfaces which are a high efficiency boiler according to part of manufactured non-liquid prod- § 761.71(a). ucts containing PCBs and meeting the (2) For liquids other than mineral oil definition of PCB bulk product waste dielectric fluid, in a high efficiency at § 761.3 must do so in accordance with boiler according to § 761.71(b). § 761.62. Any person may decontaminate (3) For liquids from incidental concrete surfaces upon which PCBs sources, such as precipitation, con- have been spilled in accordance with densation, leachate or load separation § 761.79(b)(4), if the decontamination procedure is commenced within 72 and are associated with PCB Articles hours of the initial spill of PCBs to the or non-liquid PCB wastes, in a chem- concrete or portion thereof being de- ical waste landfill which complies with contaminated. Any person may decon- § 761.75 if: taminate porous non-liquid PCBs in (i) [Reserved] contact with non-porous surfaces, such (ii) Information is provided to or ob- as underground metal fuel tanks coat- tained by the owner or operator of the ed with fire retardant resin or pitch, chemical waste landfill that shows that for purposes of unrestricted use or dis- the liquids do not exceed 500 ppm PCB posal in a smelter in accordance with and are not an ignitable waste as de- § 761.79(b)(3). scribed in § 761.75(b)(8)(iii).

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(b) PCB Articles. This paragraph does tors or PCB Equipment, and acquired not authorize disposal that is other- the PCB Capacitor in the course of wise prohibited in § 761.20 or elsewhere such manufacturing, shall place the in this part. PCB Small Capacitors in a container (1) Transformers. (i) PCB Trans- meeting the DOT packaging require- formers shall be disposed of in accord- ments at 49 CFR parts 171 through 180 ance with either of the following: and dispose of them in accordance with (A) In an incinerator that complies either of the following: with § 761.70; or (A) Disposal in an incinerator which (B) In a chemical waste landfill ap- complies with § 761.70; or proved under § 761.75; provided that all (B) Until March 1, 1981, disposal in a free-flowing liquid is removed from the chemical waste landfill which complies transformer, the transformer is filled with § 761.75. with a solvent, the transformer is al- (v) Notwithstanding the restrictions lowed to stand for at least 18 contin- imposed by paragraph (b)(2)(iii)(B) or uous hours, and then the solvent is (b)(2)(iv)(B) of this section, PCB capaci- thoroughly removed. Any person dis- tors may be disposed of in PCB chem- posing of PCB liquids that are removed ical waste landfills that comply with from the transformer (including the di- § 761.75 subsequent to March 1, 1981, if electric fluid and all solvents used as a EPA publishes a notice in the FEDERAL flush), shall do so in an incinerator REGISTER declaring that those landfills that complies with § 761.70 of this part, are available for such disposal and ex- or shall decontaminate them in accord- plaining the reasons for the extension ance with § 761.79. Solvents may include or reopening. An extension or reopen- kerosene, xylene, toluene, and other ing for disposal of PCB capacitors that solvents in which PCBs are readily is granted under this subsection shall soluble. Any person disposing of these be subject to such terms and conditions PCB liquids must ensure that the sol- as the Assistant Administrator may vent flushing procedure is conducted in prescribe and shall be in effect for such accordance with applicable safety and period as the Assistant Administrator health standards as required by Fed- may prescribe. EPA may permit dis- eral or State regulations. posal of PCB capacitors in EPA-ap- (ii) [Reserved] proved chemical waste landfills after (2) PCB Capacitors. (i) The disposal of March 1, 1981, if in its opinion, any capacitor shall comply with all re- (A) Adequate incineration capability quirements of this subpart unless it is for PCB capacitors is not available, or known from label or nameplate infor- (B) The incineration of PCB capaci- mation, manufacturer’s literature (in- tors will significantly interfere with cluding documented communications the incineration of liquid PCBs, or with the manufacturer), or chemical analysis that the capacitor does not (C) There is other good cause shown. contain PCBs. As part of this evaluation, the Assist- (ii) Any person may dispose of PCB ant Administrator will consider the Small Capacitors as municipal solid impact of his action on the incentives waste, unless that person is subject to to construct or expand PCB inciner- the requirements of paragraph (b)(2)(iv) ators. of this section. (vi) Any person disposing of large (iii) Any PCB Large High or Low PCB capacitors or small PCB capaci- Voltage Capacitor which contains 500 tors described in paragraph (b)(2)(iv) of ppm or greater PCBs, owned by any this section in a chemical waste land- person, shall be disposed of in accord- fill approved under § 761.75, shall first ance with either of the following: place them in a container meeting the (A) Disposal in an incinerator that DOT packaging requirements at 49 CFR complies with § 761.70; or parts 171 through 180. In all cases, the (B) Until March 1, 1981, disposal in a person must fill the interstitial space chemical waste landfill that complies in the container with sufficient absorb- with § 761.75. ent material (such as soil) to absorb (iv) Any person who manufactures or any liquid PCBs remaining in the ca- at any time manufactured PCB Capaci- pacitors.

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(3) PCB hydraulic machines. (i) Any doned in place under one or more of the person disposing of PCB hydraulic ma- following provisions: chines containing PCBs at concentra- (A) Natural gas pipe having a nomi- tions of ≥50 ppm, such as die casting nal inside diameter of ≤4 inches, and machines, shall do so by one of the fol- containing PCBs at any concentration lowing methods: but no free-flowing liquids, may be (A) In accordance with § 761.79. abandoned in the place it was used to (B) In a facility which is permitted, transport natural gas if each end is licensed, or registered by a State to sealed closed and the pipe is either: manage municipal solid waste subject (1) Included in a public service notifi- to part 258 of this chapter or non-mu- cation program, such as a ‘‘one-call’’ nicipal non-hazardous waste subject to system under 49 CFR 192.614(a) and (b). §§ 257.5 through 257.30 of this chapter, as (2) Filled to 50 percent or more of the applicable (excluding thermal treat- volume of the pipe with grout (such as ment units). a hardening slurry consisting of ce- (C) In a scrap metal recovery oven or ment, bentonite, or clay) or high den- smelter operating in compliance with sity polyurethane foam. § 761.72. (B) PCB-Contaminated natural gas (D) In a disposal facility approved pipe of any diameter, where the PCB under this part. concentration was determined after the (ii) All free-flowing liquid must be re- last transmission of gas through the moved from each machine and the liq- pipe or at the time of abandonment, uid must be disposed of in accordance that contains no free-flowing liquids with the provisions of paragraph (a) of may be abandoned in the place it was this section. If the PCB liquid contains used to transport natural gas if each ≥1,000 ppm PCB, then the hydraulic ma- end is sealed closed. chine must be decontaminated in ac- (C) Natural gas pipe of any diameter cordance with § 761.79 or flushed prior which contains PCBs at any concentra- to disposal with a solvent listed at tion but no free-flowing liquids, may be paragraph (b)(1)(i)(B) of this section abandoned in the place it was used to which contains <50 ppm PCB. The sol- transport natural gas, if each end is vent must be disposed of in accordance sealed closed, and either: with paragraph (a) of this section or (1) The interior surface is decontami- § 761.79. nated with one or more washes of a sol- (4) PCB-Contaminated Electrical Equip- vent in accordance with the use and ment. Any person disposing of PCB- disposal requirements of § 761.79(d). Contaminated Electrical Equipment, This decontamination process must re- except capacitors, shall do so in ac- sult in a recovery of 95 percent of the cordance with paragraph (b)(6)(ii)(A) of solvent volume introduced into the this section. Any person disposing of system, and the PCB concentration of Large Capacitors that contain ≥ 50 ppm the recovered wash must be <50 ppm but < 500 ppm PCBs shall do so in a dis- (see § 761.79(a)(1) for requirements on posal facility approved under this part. use and disposal of decontaminating (5) Natural gas pipeline systems con- fluids). taining PCBs. The owner or operator of (2) The pipe is filled to 50 percent or natural gas pipeline systems con- more of the volume of the pipe with taining ≥50 ppm PCBs, when no longer grout (such as a hardening slurry-like in use, shall dispose of the system ei- cement, bentonite, or clay) or high ther by abandonment in place of the density polyurethane foam (except that pipe under paragraph (b)(5)(i) of this only cement shall be used as grout section or removal with subsequent ac- under rivers or streams) and each end tion under paragraph (b)(5)(ii) of this is sealed closed. section. Any person determining the (D) Natural gas pipe of any diameter PCB concentrations in natural gas which contains PCBs at any concentra- pipeline systems shall do so in accord- tion may be abandoned in place after ance with paragraph (b)(5)(iii) of this decontamination in accordance with section. § 761.79(c)(3), (c)(4) or (h) or a PCB dis- (i) Abandonment. Natural gas pipe posal approval issued under § 761.60(e) containing ≥50 ppm PCBs may be aban- or § 761.61(c).

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(ii) Removal with subsequent action. to be abandoned or removed. Collect Natural gas pipeline systems may be wipe samples after the last trans- disposed of under one of the following mission of gas through the pipe or dur- provisions: ing removal from the location it was (A) The following classifications of used to transport natural gas. natural gas pipe containing no free- (B) PCB concentration of the organic flowing liquids may be disposed of in a phase of multi-phasic liquids shall be facility permitted, licensed, or reg- determined in accordance with istered by a State to manage municipal § 761.1(b)(4). solid waste subject to part 258 of this (iv) Disposal of pipeline liquids. (A) chapter or non-municipal non-haz- Any person disposing of liquids con- ardous waste subject to §§ 257.5 through taining PCBs ≥50 ppm removed, spilled, 257.30 of this chapter, as applicable (ex- or otherwise released from a natural cluding thermal treatment units); a gas pipeline system must do so in ac- scrap metal recovery oven or smelter cordance with § 761.61(a)(5)(iv) based on operating in compliance with the re- the PCB concentration at the time of quirements of § 761.72; or a disposal fa- removal from the system. Any person cility approved under this part: disposing of material contaminated by (1) PCB-Contaminated natural gas spills or other releases of PCBs ≥50 ppm pipe of any diameter where the PCB from a natural gas pipeline system, concentration was determined after the must do so in accordance with § 761.61 last transmission of gas through the or § 761.79, as applicable. pipe or during removal from the loca- (B) Any person who markets or burns tion it was used to transport natural for energy recovery liquid containing gas. PCBs at concentrations <50 ppm PCBs (2) Natural gas pipe containing PCBs at the time of removal from a natural at any concentration and having a gas pipeline system must do so in ac- nominal inside diameter ≤4 inches. cordance with the provisions per- (B) Any component of a natural gas taining to used oil at § 761.20(e). No pipeline system may be disposed of other use of liquid containing PCBs at under one of the following provisions: concentrations above the quantifiable (1) In an incinerator operating in level/level of detection removed from a compliance with § 761.70. natural gas pipeline system is author- (2) In a chemical waste landfill oper- ized. ating in compliance with § 761.75, pro- (6) Other PCB Articles. (i) PCB articles vided that all free-flowing liquid PCBs with concentrations at 500 ppm or have been thoroughly drained. greater must be disposed of: (3) As a PCB remediation waste in (A) In an incinerator that complies compliance with § 761.61. with § 761.70; or (4) In accordance with § 761.79. (B) In a chemical waste landfill that (iii) Characterization of natural gas complies with § 761.75, provided that all pipeline systems by PCB concentration in free-flowing liquid PCBs have been condensate. (A) Any person disposing of thoroughly drained from any articles a natural gas pipeline system under before the articles are placed in the paragraphs (b)(5)(i)(B) or (b)(5)(ii)(A)(1) chemical waste landfill and that the of this section must characterize it for drained liquids are disposed of in an in- PCB contamination by analyzing or- cinerator that complies with § 761.70. ganic liquids collected at existing con- (ii)(A) Except as specifically provided densate collection points in the natural in paragraphs (b)(1) through (b)(5) of gas pipeline system. The level of PCB this section, any person disposing of a contamination found at a collection PCB-Contaminated Article must do so point is assumed to extend to the next by removing all free-flowing liquid collection point downstream. If no or- from the article, disposing of the liquid ganic liquids are present, drain free- in accordance with paragraph (a) of flowing liquids and collect standard this section, and disposing of the PCB- wipe samples according to subpart M of Contaminated Article with no free- this part. Collect condensate within 72 flowing liquid by one of the following hours of the final transmission of nat- methods: ural gas through the part of the system (1) In accordance with § 761.79.

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(2) In a facility permitted, licensed, cordance with paragraph (a) of this sec- or registered by a State to manage mu- tion. nicipal solid waste subject to part 258 (2) Any PCB Container used to con- of this chapter or non-municipal non- tain only PCBs at a concentration less hazardous waste subject to §§ 257.5 than 500 ppm shall be disposed of as through 257.30 of this chapter, as appli- municipal solid wastes; provided that if cable (excluding thermal treatment the PCBs are in a liquid state, the PCB units). Container shall first be drained and the (3) In a scrap metal recovery oven or PCB liquid shall be disposed of in ac- smelter operating in compliance with cordance with paragraph (a) of this sec- § 761.72. tion. (4) In a disposal facility approved (3) Prior to disposal, a PCB container under this part. with PCB concentrations at 50 ppm or (B) Storage for disposal of PCB-Con- greater shall be stored in a unit which taminated Articles from which all free- complies with § 761.65. flowing liquids have been removed is (d) [Reserved] not regulated under subpart D of this (e) Any person who is required to in- part. cinerate any PCBs and PCB items under this subpart and who can dem- (C) Requirements in subparts J and K onstrate that an alternative method of of this part do not apply to PCB-Con- destroying PCBs and PCB items exists taminated Articles from which all free- and that this alternative method can flowing liquids have been removed. achieve a level of performance equiva- (iii) Fluorescent light ballasts con- lent to an incinerator approved under taining PCBs in their potting material § 761.70 or a high efficiency boiler oper- must be disposed of in a TSCA-ap- ating in compliance with § 761.71, must proved disposal facility, as bulk prod- submit a written request to the Re- uct waste under § 761.62, as household gional Administrator or the Director, waste under § 761.63 (where applicable), Office of Resource Conservation and or in accordance with the decon- Recovery, for a waiver from the incin- tamination provisions of § 761.79. eration requirements of § 761.70 or (7) Storage of PCB Articles. Except for § 761.71. Requests for approval of alter- a PCB Article described in paragraph nate methods that will be operated in (b)(2)(ii) of this section and hydraulic more than one Region must be sub- machines that comply with the munic- mitted to the Director, Office of Re- ipal solid waste disposal provisions de- source Conservation and Recovery, ex- scribed in paragraph (b)(3) of this sec- cept for research and development action, any PCB Article, with PCB con- tivities involving less than 500 pounds centrations at 50 ppm or greater, shall of PCB material (see paragraph (i)(2) of be stored in accordance with § 761.65 this section). Requests for approval of prior to disposal. alternate methods that will be oper- (8) Persons disposing of PCB Articles ated in only one Region must be sub- must wear or use protective clothing or mitted to the appropriate EPA Re- equipment to protect against dermal gional Administrator. The applicant contact with or inhalation of PCBs or must show that his or her method of materials containing PCBs. destroying PCBs will not present an (c) PCB Containers. (1) Unless decon- unreasonable risk of injury to health taminated in compliance with § 761.79 or the environment. On the basis of or as provided in paragraph (c)(2) of such information and any available in- this section, a PCB container with PCB formation, EPA may, in its discretion, concentrations at 500 ppm or greater approve the use of the alternate meth- shall be disposed of: od if it finds that the alternate disposal (i) In an incinerator which complies method provides PCB destruction with § 761.70, or equivalent to disposal in a § 761.60 in- (ii) In a chemical waste landfill that cinerator or a § 761.61 high efficiency complies with § 761.75; provided that if boiler and will not present an unrea- there are PCBs in a liquid state, the sonable risk of injury to health or the PCB Container shall first be drained environment. Any approval must be and the PCB liquid disposed of in ac- stated in writing and may include such

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conditions and provisions as EPA dielectric fluid from other oil-filled deems appropriate. The person to electrical equipment, the entire con- whom such waiver is issued must com- tents of the container must be treated ply with all limitations contained in as PCBs at a concentration of at least such determination. No person may use 50 ppm, unless all of the fluid from the the alternate method of destroying other oil-filled electrical equipment PCBs or PCB items prior to obtaining has been tested and shown to contain permission from the appropriate EPA less than 50 ppm PCBs. official. (ii) For purposes of complying with (f)(1) Each operator of a chemical the marking and disposal require- waste landfill, incinerator, or alter- ments, representative samples may be native to incineration approved under taken from either the common con- paragraph (e) of this section shall give tainers or the individual electrical the following written notices to the equipment to determine the PCB con- state and local governments within centration, except that if any PCBs at whose jurisdiction the disposal facility a concentration of 500 ppm or greater is located: have been added to the container or (i) Notice at least thirty (30) days be- equipment then the total container fore a facility is first used for disposal contents must be considered as having of PCBs required by these regulations; a PCB concentration of 500 ppm or and greater for purposes of complying with (ii) At the request of any state or the disposal requirements of this sub- local government, annual notice of the part. For purposes of this subpara- quantities and general description of graph, representative samples of min- PCBs disposed of during the year. This eral oil dielectric fluid are either sam- annual notice shall be given no more ples taken in accordance with ASTM D than thirty (30) days after the end of 923–86 or ASTM D 923–89 or samples the year covered. taken from a container that has been (iii) The Regional Administrator may thoroughly mixed in a manner such reduce the notice period required by that any PCBs in the container are paragraph (f)(1)(i) of this section from uniformly distributed throughout the thirty days to a period of no less than liquid in the container. five days in order to expedite interim (iii) Unless otherwise specified in this approval of the chemical waste landfill part, any person conducting the chem- located in Sedgwick County, Kansas. ical analysis of PCBs shall do so using (2) [Reserved] gas chromatography. Any gas (g) Testing procedures. (1) Owners or chromatographic method that is appro- users of mineral oil dielectric fluid priate for the material being analyzed electrical equipment may use the fol- may be used, including EPA Method lowing procedures to determine the 608, ‘‘Organochlorine Pesticides and concentration of PCBs in the dielectric PCBs’’ at 40 CFR part 136, Appendix fluid: A;’’ EPA Method 8082, ‘‘Poly- (i) Dielectric fluid removed from chlorinated Biphenyls (PCBs) by Cap- mineral oil dielectric fluid electrical illary Column Gas Chromatography’’ of equipment may be collected in a com- SW-846, ‘‘OSW Test Methods for Evalu- mon container, provided that no other ating Solid Waste,’’ which is available chemical substances or mixtures are from NTIS; and ASTM Standard D-4059, added to the container. This common ‘‘Standard Test Method for Analysis of container option does not permit dilu- Polychlorinated Biphenyls in Insu- tion of the collected oil. Mineral oil lating Liquids by Gas Chroma- that is assumed or known to contain at tography,’’ which is available from least 50 ppm PCBs must not be mixed ASTM. with mineral oil that is known or as- (2) Owners or users of waste oil may sumed to contain less than 50 ppm use the following procedures to deter- PCBs to reduce the concentration of mine the PCB concentration of waste PCBs in the common container. If di- oil: electric fluid from untested, oil-filled (i) Waste oil from more than one circuit breakers, reclosers, or cable is source may be collected in a common collected in a common container with container, provided that no other

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chemical substances or mixtures, such will be conducted, and R&D for PCB as non-waste oils, are added to the con- disposal using 500 pounds or more of tainer. PCB material (regardless of PCB con- (ii) For purposes of complying with centration) will be reviewed and ap- the marking and disposal require- proved by the EPA. ments, representative samples may be (j) Self-implementing requirements for taken from either the common con- research and development (R&D) for PCB tainers or the individual electrical disposal. (1) Any person may conduct equipment to determine the PCB con- R&D for PCB disposal without prior centration. Except, That if any PCBs at written approval from EPA if they a concentration of 500 ppm or greater meet the following conditions: have been added to the container or (i) File a notification and obtain an equipment then the total container EPA identification number pursuant to contents must be considered as having subpart K of this part. a PCB concentration of 500 ppm or (ii) Notify in writing the EPA Re- greater for purposes of complying with gional Administrator, the State envi- the disposal requirements of this sub- ronmental protection agency, and local part. For purposes of this paragraph, environmental protection agency, hav- representative samples of mineral oil ing jurisdiction where the R&D for dielectric fluid are either samples PCB disposal activity will occur at taken in accordance with ASTM D 923– least 30 days prior to the commence- 86 or ASTM D 923–89 or samples taken ment of any R&D for PCB disposal ac- from a container that has been thor- tivity conducted under this section. oughly mixed in a manner such that Each written notification shall include any PCBs in the container are uni- the EPA identification number of the formly distributed throughout the liq- site where the R&D for PCB disposal uid in the container. activities will be conducted, the quan- (iii) Unless otherwise specified in this tity of PCBs to be treated, the type of part, any person conducting the chem- R&D technology to be used, the general ical analysis of PCBs shall do so using physical and chemical properties of gas chromatography. Any gas material being treated, and an esti- chromatographic method that is appro- mate of the duration of the PCB activ- priate for the material being analyzed ity. The EPA Regional Administrator, may be used, including those indicated the State environmental protection in paragraph (g)(1)(iii) of this section. agency, and the local environmental (h) Requirements for export and im- protection agency may waive notifica- port of PCBs and PCB Items for dis- tion in writing prior to commencement posal are found in Subpart F of this of the research. part. (iii) The amount of material con- (i) Approval authority for disposal taining PCBs treated annually by the methods. (1) The officials designated in facility during R&D for PCB disposal §§ 761.60(e) and 761.70 (a) and (b) to re- activities does not exceed 500 gallons or ceive requests for approval of PCB dis- 70 cubic feet of liquid or non-liquid posal activities are the primary ap- PCBs and does not exceed a maximum proval authorities for these activities. concentration of 10,000 ppm PCBs. Notwithstanding, EPA may, at its dis- (iv) No more than 1 kilogram total of cretion, assign the authority to review pure PCBs per year is disposed of in all and approve any aspect of a disposal R&D for PCB disposal activities at a system to the Office of Solid Waste and facility. Emergency Response or to a Regional (v) Each R&D for PCB disposal activ- Administrator. ity under this section lasts no more (2) Except for activity authorized than 1 calendar year. under paragraph (j) of this section, re- (vi) Store all PCB wastes (treated search and development (R&D) for PCB and untreated PCB materials, testing disposal using a total of <500 pounds of samples, spent laboratory samples, re- PCB material (regardless of PCB con- siduals, untreated samples, contami- centration) will be reviewed and ap- nated media or instrumentation, cloth- proved by the EPA Regional Adminis- ing, etc.) in compliance with § 761.65(b) trator for the Region where the R&D and dispose of them according to the

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undiluted PCB concentration prior to ble to the R&D for PCB disposal activ- treatment. However, PCB materials ity. not treated in the R&D for PCB dis- (3) The EPA Regional Administrator posal activity may be returned either for the Region in which an R&D for to the physical location where the sam- PCB disposal activity is conducted may ples were collected or a location where determine, at any time, that an R&D other regulated PCBs from the physical PCB disposal approval is required location where the samples were col- under paragraphs (e) and (i)(2) of this lected are being stored for disposal. section or § 761.70(d) to ensure that any (vii) Use manifests pursuant to sub- R&D for PCB disposal activity does not part K of this part for all R&D PCB present an unreasonable risk of injury wastes being transported from the R&D to health or the environment. facility to an approved PCB storage or (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C. disposal facility. However, §§ 761.207 2605) through 761.218 do not apply if the re- [44 FR 31542, May 31, 1979] siduals or treated samples are returned EDITORIAL NOTE: For FEDERAL REGISTER ci- either to the physical location where tations affecting § 761.60, see the List of CFR the samples were collected or a loca- Sections Affected, which appears in the tion where other regulated PCBs from Finding Aids section of the printed volume the physical location where the sam- and at www.fdsys.gov. ples were collected are being stored for disposal. § 761.61 PCB remediation waste. (viii) Package and ship all PCB This section provides cleanup and wastes pursuant to DOT requirements disposal options for PCB remediation under 49 CFR parts 171 through 180. waste. Any person cleaning up and dis- (ix) Comply with the recordkeeping posing of PCBs managed under this sec- requirements of § 761.180. tion shall do so based on the concentra- (2) Do not exceed material limitation at which the PCBs are found. This tions set out in paragraphs (j)(1) (iii) section does not prohibit any person and (iv) of this section and the time from implementing temporary emer- limitation set out in paragraph (j)(1)(v) gency measures to prevent, treat, or contain further releases or mitigate of this section without prior written migration to the environment of PCBs approval from EPA. Requests for ap- or PCB remediation waste. proval to exceed the material limita- (a) Self-implementing on-site cleanup tions for PCBs in R&D for PCB disposal and disposal of PCB remediation waste. activities as specified in this section EPA designed the self-implementing must be submitted in writing to the procedure for a general, moderately- EPA Regional Administrator for the sized site where there should be low re- Region in which the facility con- sidual environmental impact from re- ducting R&D for PCB disposal activi- medial activities. The procedure may ties is located. Each request shall be less practical for larger or environ- specify the quantity or concentration mentally diverse sites. For these other requested or additional time needed for sites, the self-implementing procedure disposal and include a justification for still applies, but an EPA Regional Ad- each increase. For extensions to the ministrator may authorize more prac- duration of the R&D for PCB disposal tical procedures through paragraph (c) activity, the request shall also include of this section. Any person may con- a report on the accomplishments and duct self-implementing cleanup and progress of the previously authorized disposal of PCB remediation waste in R&D for PCB disposal activity for accordance with the following require- which the extension is sought. The ments without prior written approval EPA Regional Administrator may from EPA. grant a waiver in writing for an in- (1) Applicability. (i) The self-imple- crease in the volume of PCB material, menting procedures may not be used to the maximum concentration of PCBs, clean up: the total amount of pure PCBs, or the (A) Surface or ground waters. duration of the R&D activity. Approv- (B) Sediments in marine and fresh- als will state all requirements applica- water ecosystems.

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(C) Sewers or sewage treatment sys- data summary from paragraph tems. (a)(3)(i)(B) of this section. (D) Any private or public drinking (D) A cleanup plan for the site, in- water sources or distribution systems. cluding schedule, disposal technology, (E) Grazing lands. and approach. This plan should contain (F) Vegetable gardens. options and contingencies to be used if (ii) The self-implementing cleanup unanticipated higher concentrations or provisions shall not be binding upon wider distributions of PCB remediation cleanups conducted under other au- waste are found or other obstacles thorities, including but not limited to, force changes in the cleanup approach. actions conducted under section 104 or (E) A written certification, signed by section 106 of CERCLA, or section the owner of the property where the 3004(u) and (v) or section 3008(h) of cleanup site is located and the party RCRA. conducting the cleanup, that all sam- (2) Site characterization. Any person pling plans, sample collection proce- conducting self-implementing cleanup dures, sample preparation procedures, of PCB remediation waste must charac- extraction procedures, and instru- terize the site adequately to be able to mental/chemical analysis procedures provide the information required by used to assess or characterize the PCB paragraph (a)(3) of this section. Sub- contamination at the cleanup site, are part N of this part provides a method on file at the location designated in the for collecting new site characterization certificate, and are available for EPA data or for assessing the sufficiency of inspection. Persons using alternate existing site characterization data. methods for chemical extraction and (3) Notification and certification. (i) At chemical analysis for site characteriza- least 30 days prior to the date that the tion must include in the certificate a cleanup of a site begins, the person in statement that such a method will be charge of the cleanup or the owner of used and that a comparison study the property where the PCB remedi- which meets or exceeds the require- ation waste is located shall notify, in ments of subpart Q of this part, and for writing, the EPA Regional Adminis- which records are on file, has been trator, the Director of the State or completed prior to verification sam- Tribal environmental protection agen- pling. cy, and the Director of the county or (ii) Within 30 calendar days of receiv- local environmental protection agency ing the notification, the EPA Regional where the cleanup will be conducted. Administrator will respond in writing The notice shall include: approving of the self-implementing (A) The nature of the contamination, cleanup, disapproving of the self-imple- including kinds of materials contami- menting cleanup, or requiring addi- nated. tional information. If the EPA Re- (B) A summary of the procedures gional Administrator does not respond used to sample contaminated and adja- within 30 calendar days of receiving the cent areas and a table or cleanup site notice, the person submitting the noti- map showing PCB concentrations fication may assume that it is com- measured in all pre-cleanup character- plete and acceptable and proceed with ization samples. The summary must in- the cleanup according to the informa- clude sample collection and analysis tion the person provided to the EPA dates. The EPA Regional Adminis- Regional Administrator. Once cleanup trator may require more detailed infor- is underway, the person conducting the mation including, but not limited to, cleanup must provide any proposed additional characterization sampling changes from the notification to the or all sample identification numbers EPA Regional Administrator in writ- from all previous characterization ac- ing no less than 14 calendar days prior tivities at the cleanup site. to the proposed implementation of the (C) The location and extent of the change. The EPA Regional Adminis- identified contaminated area, includ- trator will determine in his or her dis- ing topographic maps with sample col- cretion whether to accept the change, lection sites cross referenced to the and will respond to the change notifi- sample identification numbers in the cation verbally within 7 calendar days

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and in writing within 14 calendar days the site is covered with a cap meeting of receiving it. If the EPA Regional Ad- the requirements of paragraphs (a)(7) ministrator does not respond verbally and (a)(8) of this section. within 7 calendar days and in writing (ii) Non-porous surfaces. In high occu- within 14 calendar days of receiving the pancy areas, the surface PCB cleanup change notice, the person who sub- standard is ≤ 10 μg/100 cm2 of surface mitted it may deem it complete and area. In low occupancy areas, the sur- acceptable and proceed with the clean- face cleanup standard is <100 μg/100 cm2 up according to the information in the of surface area. Select sampling loca- change notice provided to the EPA Re- tions in accordance with subpart P of gional Administrator. this part or a sampling plan approved (iii) Any person conducting a cleanup under paragraph (c) of this section. activity may obtain a waiver of the 30- day notification requirement, if they (iii) Porous surfaces. In both high and receive a separate waiver, in writing, low occupancy areas, any person dis- from each of the agencies they are re- posing of porous surfaces must do so quired to notify under this section. The based on the levels in paragraph person must retain the original written (a)(4)(i) of this section. Porous surfaces waiver as required in paragraph (a)(9) may be cleaned up for use in accord- of this section. ance with § 761.79(b)(4) or § 761.30(p). (4) Cleanup levels. For purposes of (iv) Liquids. In both high and low oc- cleaning, decontaminating, or remov- cupancy areas, cleanup levels are the ing PCB remediation waste under this concentrations specified in § 761.79(b)(1) section, there are four general waste and (b)(2). categories: bulk PCB remediation (v) Change in the land use for a clean- waste, non-porous surfaces, porous sur- up site. Where there is an actual or pro- faces, and liquids. Cleanup levels are posed change in use of an area cleaned based on the kind of material and the up to the levels of a low occupancy potential exposure to PCBs left after area, and the exposure of people or ani- cleanup is completed. mal life in or at that area could reason- (i) Bulk PCB remediation waste. Bulk ably be expected to increase, resulting PCB remediation waste includes, but is in a change in status from a low occu- not limited to, the following non-liquid pancy area to a high occupancy area, PCB remediation waste: soil, sediments, dredged materials, muds, PCB the owner of the area shall clean up the sewage sludge, and industrial sludge. area in accordance with the high occu- (A) High occupancy areas. The cleanup pancy area cleanup levels in para- level for bulk PCB remediation waste graphs (a)(4)(i) through (a)(4)(iv) of this in high occupancy areas is ≤1 ppm section. without further conditions. High occu- (vi) The EPA Regional Adminis- pancy areas where bulk PCB remedi- trator, as part of his or her response to ation waste remains at concentrations a notification submitted in accordance >1 ppm and ≤10 ppm shall be covered with § 761.61(a)(3) of this part, may re- with a cap meeting the requirements of quire cleanup of the site, or portions of paragraphs (a)(7) and (a)(8) of this sec- it, to more stringent cleanup levels tion. than are otherwise required in this sec- (B) Low occupancy areas. (1) The tion, based on the proximity to areas cleanup level for bulk PCB remediation such as residential dwellings, hospitals, waste in low occupancy areas is ≤25 schools, nursing homes, playgrounds, ppm unless otherwise specified in this parks, day care centers, endangered paragraph. species habitats, estuaries, wetlands, (2) Bulk PCB remediation wastes national parks, national wildlife ref- may remain at a cleanup site at con- uges, commercial fisheries, and sport centrations >25 ppm and ≤50 ppm if the fisheries. site is secured by a fence and marked (5) Site cleanup. In addition to the op- with a sign including the ML mark. (3) Bulk PCB remediation wastes tions set out in this paragraph, PCB may remain at a cleanup site at con- disposal technologies approved under centrations >25 ppm and ≤100 ppm if §§ 761.60 and 761.70 are acceptable for

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on-site self-implementing PCB remedi- a PCB disposal facility approved under ation waste disposal within the con- this part. fines of the operating conditions of the (iv) The generator must provide writ- respective approvals. ten notice, including the quantity to be (i) Bulk PCB remediation waste. Any shipped and highest concentration of person cleaning up bulk PCB remedi- PCBs (using extraction EPA Method ation waste shall do so to the levels in 3500B/3540C or Method 3500B/3550B fol- paragraph (a)(4)(i) of this section. lowed by chemical analysis using EPA (A) Any person cleaning up bulk PCB Method 8082 in SW-846 or methods vali- remediation waste on-site using a soil dated under subpart Q of this part) at washing process may do so without least 15 days before the first shipment EPA approval, subject to all of the fol- of bulk PCB remediation waste from lowing: each cleanup site by the generator, to (1) A non-chlorinated solvent is used. each off-site facility where the waste is (2) The process occurs at ambient destined for an area not subject to a temperature. TSCA PCB Disposal Approval. (3) The process is not exothermic. (3) Any person may decontaminate (4) The process uses no external heat. bulk PCB remediation waste in accord- (5) The process has secondary con- ance with § 761.79 and return the waste tainment to prevent any solvent from to the cleanup site for disposal as long being released to the underlying or sur- as the cleanup standards of paragraph rounding soils or surface waters. (a)(4) of this section are met. (6) Solvent disposal, recovery, and/or (ii) Non-porous surfaces. PCB remedi- reuse is in accordance with relevant ation waste non-porous surfaces shall provisions of approvals issued accord- be cleaned on-site or off-site for dis- ing to paragraphs (b)(1) or (c) of this posal on-site, disposal off-site, or use, section or applicable paragraphs of as follows: § 761.79. (A) For on-site disposal, non-porous (B) Bulk PCB remediation waste may surfaces shall be cleaned on-site or off- be sent off-site for decontamination or site to the levels in paragraph (a)(4)(ii) disposal in accordance with this para- of this section using: graph, provided the waste is either (1) Procedures approved under dewatered on-site or transported off- § 761.79. site in containers meeting the require- (2) Technologies approved under ments of the DOT Hazardous Materials § 761.60(e). Regulations (HMR) at 49 CFR parts 171 (3) Procedures or technologies ap- through 180. proved under paragraph (c) of this sec- (1) Removed water shall be disposed tion. of according to paragraph (b)(1) of this (B) For off-site disposal, non-porous section. surfaces: (2) Any person disposing off-site of (1) Having surface concentrations dewatered bulk PCB remediation waste <100 μg/100 cm2 shall be disposed of in shall do so as follows: accordance with paragraph (i) Unless sampled and analyzed for (a)(5)(i)(B)(2)(ii) of this section. Metal disposal according to the procedures surfaces may be thermally decontami- set out in §§ 761.283, 761.286, and 761.292, nated in accordance with the bulk PCB remediation waste shall § 761.79(c)(6)(i). be assumed to contain ≥ 50 ppm PCBs. (2) Having surface concentrations (ii) Bulk PCB remediation wastes ≥100 μg/100 cm2 shall be disposed of in with a PCB concentration of <50 ppm accordance with paragraph shall be disposed of in accordance with (a)(5)(i)(B)(2)(iii) of this section. Metal paragraph (a)(5)(v)(A) of this section. surfaces may be thermally decontami- (iii) Bulk PCB remediation wastes nated in accordance with with a PCB concentration ≥50 ppm § 761.79(c)(6)(ii). shall be disposed of in a hazardous (C) For use, non-porous surfaces shall waste landfill permitted by EPA under be decontaminated on-site or off-site to section 3004 of RCRA, or by a State au- the standards specified in § 761.79(b)(3) thorized under section 3006 of RCRA, or or in accordance with § 761.79(c).

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(iii) Porous surfaces. Porous surfaces surfaces must do so in accordance with shall be disposed on-site or off-site as subpart P of this part. Any person col- bulk PCB remediation waste according lecting and analyzing samples from liq- to paragraph (a)(5)(i) of this section or uids must do so in accordance with decontaminated for use according to § 761.269. Any person conducting in- § 761.79(b)(4), as applicable. terim sampling during PCB remedi- (iv) Liquids. Any person disposing of ation waste cleanup to determine when liquid PCB remediation waste shall ei- to sample to verify that cleanup is ther: complete, may use PCB field screening (A) Decontaminate the waste to the tests. levels specified in § 761.79(b)(1) or (b)(2). (ii) Verification. (A) Where sample (B) Dispose of the waste in accord- analysis results in a measurement of ance with paragraph (b) of this section PCBs less than or equal to the levels or an approval issued under paragraph specified in paragraph (a)(4) of this sec- (c) of this section. tion, self-implementing cleanup is (v) Cleanup wastes. Any person gener- complete. ating the following wastes during and (B) Where sample analysis results in from the cleanup of PCB remediation a measurement of PCBs greater than waste shall dispose of or reuse them the levels specified in paragraph (a)(4) using one of the following methods: of this section, self-implementing (A) Non-liquid cleaning materials cleanup of the sampled PCB remedi- and personal protective equipment ation waste is not complete. The owner waste at any concentration, including or operator of the site must either dis- non-porous surfaces and other non-liq- pose of the sampled PCB remediation uid materials such as rags, gloves, booties, other disposable personal protec- waste, or reclean the waste represented tive equipment, and similar materials by the sample and reinitiate sampling resulting from cleanup activities shall and analysis in accordance with para- be either decontaminated in accord- graph (a)(6)(i) of this section. ance with § 761.79(b) or (c), or disposed (7) Cap requirements. A cap means, of in one of the following facilities, when referring to on-site cleanup and without regard to the requirements of disposal of PCB remediation waste, a subparts J and K of this part: uniform placement of concrete, as- (1) A facility permitted, licensed, or phalt, or similar material of minimum registered by a State to manage munic- thickness spread over the area where ipal solid waste subject to part 258 of remediation waste was removed or left this chapter. in place in order to prevent or mini- (2) A facility permitted, licensed, or mize human exposure, infiltration of registered by a State to manage non- water, and erosion. Any person design- municipal non-hazardous waste subject ing and constructing a cap must do so to §§ 257.5 through 257.30 of this chapter, in accordance with § 264.310(a) of this as applicable. chapter, and ensure that it complies (3) A hazardous waste landfill per- with the permeability, sieve, liquid mitted by EPA under section 3004 of limit, and plasticity index parameters RCRA, or by a State authorized under in § 761.75(b)(1)(ii) through (b)(1)(v). A section 3006 of RCRA. cap of compacted soil shall have a min- (4) A PCB disposal facility approved imum thickness of 25 cm (10 inches). A under this part. concrete or asphalt cap shall have a (B) Cleaning solvents, abrasives, and minimum thickness of 15 cm (6 inches). equipment may be reused after decon- A cap must be of sufficient strength to tamination in accordance with § 761.79. maintain its effectiveness and integ- (6) Cleanup verification—(i) Sampling rity during the use of the cap surface and analysis. Any person collecting and which is exposed to the environment. A analyzing samples to verify the clean- cap shall not be contaminated at a up and on-site disposal of bulk PCB re- level ≥1 ppm PCB per AroclorTM (or mediation wastes and porous surfaces equivalent) or per congener. Repairs must do so in accordance with subpart shall begin within 72 hours of discovery O of this part. Any person collecting for any breaches which would impair and analyzing samples from non-porous the integrity of the cap.

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(8) Deed restrictions for caps, fences (i) Dispose of it in a high tempera- and low occupancy areas. When a clean- ture incinerator approved under up activity conducted under this sec- § 761.70(b), an alternate disposal method tion includes the use of a fence or a approved under § 761.60(e), a chemical cap, the owner of the site must main- waste landfill approved under § 761.75, tain the fence or cap, in perpetuity. In or in a facility with a coordinated ap- addition, whenever a cap, or the proce- proval issued under § 761.77. dures and requirements for a low occu- (ii) Decontaminate it in accordance pancy area, is used, the owner of the with § 761.79. site must meet the following condi- (3) Any person may manage or dis- tions: pose of material containing <50 ppm (i) Within 60 days of completion of a PCBs that has been dredged or exca- cleanup activity under this section, the vated from waters of the United States: owner of the property shall: (A) Record, in accordance with State (i) In accordance with a permit that law, a notation on the deed to the prop- has been issued under section 404 of the erty, or on some other instrument Clean Water Act, or the equivalent of which is normally examined during a such a permit as provided for in regula- title search, that will in perpetuity no- tions of the U.S. Army Corps of Engi- tify any potential purchaser of the neers at 33 CFR part 320. property: (ii) In accordance with a permit (1) That the land has been used for issued by the U.S. Army Corps of Engi- PCB remediation waste disposal and is neers under section 103 of the Marine restricted to use as a low occupancy Protection, Research, and Sanctuaries area as defined in § 761.3. Act, or the equivalent of such a permit (2) Of the existence of the fence or as provided for in regulations of the cap and the requirement to maintain U.S. Army Corps of Engineers at 33 the fence or cap. CFR part 320. (3) The applicable cleanup levels left (c) Risk-based disposal approval. (1) at the site, inside the fence, and/or Any person wishing to sample, cleanup, under the cap. or dispose of PCB remediation waste in (B) Submit a certification, signed by a manner other than prescribed in the owner, that he/she has recorded the paragraphs (a) or (b) of this section, or notation specified in paragraph store PCB remediation waste in a man- (a)(8)(i)(A) of this section to the EPA ner other than prescribed in § 761.65, Regional Administrator. must apply in writing to the Regional (ii) The owner of a site being cleaned Administrator in the Region where the up under this section may remove a sampling, cleanup, disposal, or storage fence or cap after conducting addi- site is located, for sampling, cleanup, tional cleanup activities and achieving disposal, or storage occurring in a sin- cleanup levels, specified in paragraph (a)(4) of this section, which do not re- gle EPA Region; or to the Director, Of- quire a cap or fence. The owner may re- fice of Resource Conservation and Re- move the notice on the deed no earlier covery, for sampling, cleanup, disposal, than 30 days after achieving the clean- or storage occurring in more than one up levels specified in this section which EPA Region. Each application must in- do not require a fence or cap. clude information described in the no- (9) Recordkeeping. For paragraphs tification required by paragraph (a)(3) (a)(3), (a)(4), and (a)(5) of this section, of this section. EPA may request other recordkeeping is required in accord- information that it believes necessary ance with § 761.125(c)(5). to evaluate the application. No person (b) Performance-based disposal. (1) Any may conduct cleanup activities under person disposing of liquid PCB remedi- this paragraph prior to obtaining writ- ation waste shall do so according to ten approval by EPA. § 761.60(a) or (e), or decontaminate it in (2) EPA will issue a written decision accordance with § 761.79. on each application for a risk-based (2) Any person disposing of non-liquid method for PCB remediation wastes. PCB remediation waste shall do so by EPA will approve such an application if one of the following methods: it finds that the method will not pose

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an unreasonable risk of injury to PCB bulk product waste from the health or the environment. shredding of automobiles or household appliances from which PCB small ca- [63 FR 35448, June 29, 1998, as amended at 64 FR 33761, June 24, 1999; 72 FR 57239, Oct. 9, pacitors have been removed (shredder 2007; 74 FR 30232, June 25, 2009] fluff). (ii) Other PCB bulk product waste, § 761.62 Disposal of PCB bulk product sampled in accordance with the proto- waste. cols set out in subpart R of this part, PCB bulk product waste shall be dis- that leaches PCBs at <10 μg/L of water posed of in accordance with paragraph measured using a procedure used to (a), (b), or (c) of this section. Under simulate leachate generation. some of these provisions, it may not be (2) Any person may dispose of PCB necessary to determine the PCB con- bulk product waste other than those centration or leaching characteristics materials meeting the conditions of of the PCB bulk product waste. When it paragraph (b)(1) of this section, (e.g., is necessary to analyze the waste to paper or felt gaskets contaminated by make either of these determinations, liquid PCBs in a facility that is per- use the applicable procedures in submitted, licensed, or registered by a part R of this part to sample the waste State to manage municipal solid waste for analysis, unless EPA approves an- subject to part 258 of this chapter or other sampling plan under paragraph non-municipal non-hazardous waste (c) of this section. subject to §§ 257.5 through 257.30 of this (a) Performance-based disposal. Any chapter, as applicable, if: person disposing of PCB bulk product (i) The PCB bulk product waste is waste may do so as follows: segregated from organic liquids dis- (1) In an incinerator approved under posed of in the landfill unit. § 761.70. (ii) Leachate is collected from the (2) In a chemical waste landfill ap- landfill unit and monitored for PCBs. proved under § 761.75. (3) Any release of PCBs (including (3) In a hazardous waste landfill per- but not limited to leachate) from the mitted by EPA under section 3004 of landfill unit shall be cleaned up in ac- RCRA, or by a State authorized under cordance with § 761.61. section 3006 of RCRA. (4)(i) Any person disposing off-site of (4) Under an alternate disposal ap- PCB bulk product waste regulated proval under § 761.60(e). under paragraph (b)(1) of this section (5) In accordance with the decon- at a waste management facility not tamination provisions of § 761.79. having a commercial PCB storage or (6) For metal surfaces in contact disposal approval must provide written with PCBs, in accordance with the notice to the facility a minimum of 15 thermal decontamination provisions of days in advance of the first shipment § 761.79(c)(6). from the same disposal waste stream. (7) In accordance with a TSCA PCB The notice shall state that the PCB Coordinated Approval issued under bulk product waste may include com- § 761.77. ponents containing PCBs at ≥ 50 ppm (b) Disposal in solid waste landfills. (1) based on analysis of the waste in the Any person may dispose of the fol- shipment or application of a general lowing PCB bulk product waste in a fa- knowledge of the waste stream (or cility permitted, licensed, or registered similar material) which is known to by a State as a municipal or non-mu- contain PCBs at those levels, and that nicipal non-hazardous waste landfill: the PCB bulk product waste is known (i) Plastics (such as plastic insulation or presumed to leach <10 μg/L PCBs. from wire or cable; radio, television (ii) Any person disposing off-site of and computer casings; vehicle parts; or PCB bulk product waste regulated furniture laminates); preformed or under paragraph (b)(2) of this section molded rubber parts and components; at a waste management facility not applied dried paints, varnishes, waxes having a commercial PCB storage or or other similar coatings or sealants; disposal approval must provide written caulking; Galbestos; non-liquid build- notice to the facility a minimum of 15 ing demolition debris; or non-liquid days in advance of the first shipment

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from the same disposal waste stream that the method will not pose an un- and with each shipment thereafter. The reasonable risk of injury to health or notice shall state that the PCB bulk the environment. product waste may include components (d) Disposal as daily landfill cover or containing PCBs at ≥50 ppm based on roadbed. Bulk product waste described analysis of the waste in the shipment in paragraph (b)(1) of this section may or application of a general knowledge be disposed of: of the waste stream (or similar mate- (1) As daily landfill cover as long as rial) which is known to contain PCBs the daily cover remains in the landfill at those levels, and that the PCB bulk and is not released or dispersed by wind product waste is known or presumed to or other action; or leach ≥10 μg/L PCBs. (2) Under asphalt as part of a road (5) Any person disposing of PCB bulk bed. product waste must maintain a written record of all sampling and analysis of [63 FR 35451, June 29, 1998, as amended at 64 PCBs or notifications made under this FR 33761, June 24, 1999; 72 FR 57239, Oct. 9, 2007; 74 FR 30232, June 25, 2009] paragraph for 3 years from the date of the waste’s generation. The records § 761.63 PCB household waste storage must be made available to EPA upon and disposal. request. (6) Requirements in subparts C, J, PCB household waste, as defined at and K of this part do not apply to § 761.3, managed in a facility permitted, waste disposed of under paragraph (b) licensed, or registered by a State to of this section. manage municipal or industrial solid (c) Risk-based disposal approval. (1) waste, or in a facility with an approval Any person wishing to sample or dis- to dispose of PCB bulk product waste pose of PCB bulk product waste in a under § 761.62(c), is not subject to any manner other than prescribed in para- other requirements of part 761 of this graphs (a) or (b) of this section, or chapter. PCB household waste stored in store PCB bulk product waste in a a unit regulated for storage of PCB manner other than prescribed in waste must not be commingled with § 761.65, must apply in writing to the PCB waste. Regional Administrator in the Region [63 FR 35452, June 29, 1998] where the sampling, disposal, or storage site is located, for sampling, dis- § 761.64 Disposal of wastes generated posal, or storage occurring in a single as a result of research and develop- EPA Region; or to the Director, Office ment activities authorized under of Resource Conservation and Recov- § 761.30(j) and chemical analysis of ery, for sampling, disposal, or storage PCBs. occurring in more than one EPA Re- This section provides disposal region. Each application must contain quirements for wastes generated during information indicating that, based on and as a result of research and develop- technical, environmental, or waste-spe- ment authorized under § 761.30(j). This cific characteristics or considerations, section also provides disposal require- the proposed sampling, disposal, or ments for wastes generated during the storage methods or locations will not chemical analysis of samples con- pose an unreasonable risk or injury to taining PCBs under part 761, including health or the environment. EPA may §§ 761.30, 761.60, 761.61, 761.62, and 761.79. request other information that it be- For determining the presence of PCBs lieves necessary to evaluate the appli- in samples, chemical analysis includes: cation. No person may conduct sam- sample preparation, sample extraction, pling, disposal, or storage activities extract cleanup, extract concentration, under this paragraph prior to obtaining addition of PCB standards, and instru- written approval by EPA. mental analysis. (2) EPA will issue a written decision (a) Portions of samples of a size des- on each application for a risk-based ignated in a chemical extraction and sampling, disposal, or storage method analysis method for PCBs and ex- for PCB bulk product wastes. EPA will tracted for purposes of determining the approve such an application if it finds presence of PCBs or concentration of

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PCBs are unregulated for PCB disposal limit expires and the notice identifies under this part. the storer, the types, volumes, and lo- (b) All other wastes generated during cations of the waste and the reasons these activities are regulated for dis- for failure to meet the initial 1-year posal based on their concentration at time limit. the time of disposal as follows: (ii) A written record documenting all (1) Liquid wastes, including rinse sol- continuing attempts to secure disposal vents, must be disposed of according to is maintained until the waste is dis- § 761.61(a)(5)(iv). posed of. (2) Non-liquid wastes must be dis- (iii) The written record required by posed of in the same manner as non-liq- paragraph (a)(2)(ii) of this section is uid cleaning materials and personal available for inspection or submission protective equipment waste according if requested by EPA. to § 761.61(a)(5)(v)(A). (iv) Continuing attempts to secure [63 FR 35452, June 29, 1998] disposal were initiated within 270 days after the time the waste was first sub- § 761.65 Storage for disposal. ject to the 1-year time limit require- This section applies to the storage ment, as specified in paragraph (a)(1) of for disposal of PCBs at concentrations this section. Failure to initiate and of 50 ppm or greater and PCB Items continue attempts to secure disposal with PCB concentrations of 50 ppm or throughout the total time the waste is greater. in storage shall automatically dis- (a)(1) Storage limitations. Any PCB qualify the notifier from receiving an waste shall be disposed of as required automatic extension under this sec- by subpart D of this part within 1-year tion. from the date it was determined to be (3) Additional extensions. Upon written PCB waste and the decision was made request, the EPA Regional Adminis- to dispose of it. This date is the date of trator for the Region in which the removal from service for disposal and wastes are stored or the appropriate of- the point at which the 1-year time ficial at EPA Headquarters, may grant frame for disposal begins. PCB/radio- additional extensions beyond the 1- active waste removed from service for year extension authorized in paragraph disposal is exempt from the 1-year time (a)(2) of this section. At the time of the limit provided that the provisions at request, the requestor must supply spe- paragraphs (a)(2)(ii) and (a)(2)(iii) of cific justification for the additional ex- this section are followed and the waste tension and indicate what measures is managed in accordance with all the requestor is taking to secure dis- other applicable Federal, State, and posal of the waste or indicate why dis- local laws and regulations for the man- posal could not be conducted during agement of radioactive material. the period of the prior extension. The (2) One-year extension. Any person EPA Regional Administrator or the ap- storing PCB waste that is subject to propriate official at EPA Headquarters the 1-year time limit for storage and may require, as a condition to granting disposal in paragraph (a)(1) of this sec- any extension under this section, spe- tion may provide written notification cific actions including, but not limited to the EPA Regional Administrator for to, marking, inspection, recordkeeping, the Region in which the PCB waste is or financial assurance to ensure that stored that their continuing attempts the waste does not pose an unreason- to dispose of or secure disposal for able risk of injury to health or the en- their waste within the 1-year time vironment. limit have been unsuccessful. Upon re- (4) Storage at an approved facility. In- ceipt of the notice by the EPA Re- creased time for storage may be grant- gional Administrator, the time for dis- ed as a condition of any TSCA PCB posal is automatically extended for 1 storage or disposal approval, by the additional year (2 years total) if the EPA Regional Administrator for the following conditions are met: Region in which the PCBs or PCB (i) The notification is received by the Items are to be stored or disposed of, or EPA Regional Administrator at least by the appropriate official at EPA 30 days before the initial 1-year time Headquarters, if EPA determines that

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there is a demonstrated need or jus- (2) No person may store PCBs and tification for additional time, that the PCB Items designated for disposal in a owner or operator of the facility is pur- storage unit other than one approved suing relevant treatment or disposal pursuant to paragraph (d) of this sec- options, and that no unreasonable risk tion or meeting the design require- of injury to health or the environment ments of paragraph (b) of this section, will result from the increased storage unless the unit meets one of the fol- time. In making this determination, lowing conditions: EPA will consider such factors as ab- (i) Is permitted by EPA under section sence of any approved treatment tech- 3004 of RCRA to manage hazardous nology and insufficient time to com- waste in containers, and spills of PCBs plete the treatment or destruction are cleaned up in accordance with sub- process. EPA may require as a condi- part G of this part. tion of the approval that the owner or (ii) Qualifies for interim status under operator submit periodic progress reports. section 3005 of RCRA to manage haz- (b) Except as provided in paragraphs ardous waste in containers, meets the (b)(2), (c)(1), (c)(7), (c)(9), and (c)(10) of requirements for containment at this section, after July 1, 1978, owners § 264.175 of this chapter, and spills of or operators of any facilities used for PCBs are cleaned up in accordance the storage of PCBs and PCB Items with subpart G of this part. designated for disposal shall comply (iii) Is permitted by a State author- with the following storage unit re- ized under section 3006 of RCRA to quirements: manage hazardous waste in containers, (1) The facilities shall meet the fol- and spills of PCBs are cleaned up in ac- lowing criteria: cordance with subpart G of this part. (i) Adequate roof and walls to pre- (iv) Is approved or otherwise regu- vent rain water from reaching the lated pursuant to a State PCB waste stored PCBs and PCB Items; management program no less stringent (ii) An adequate floor that has con- in protection of health or the environ- tinuous curbing with a minimum 6 inch ment than the applicable TSCA re- high curb. The floor and curbing must quirements found in this part. provide a containment volume equal to (v) Is subject to a TSCA Coordinated at least two times the internal volume Approval, which includes provisions for of the largest PCB Article or PCB Con- storage of PCBs, issued pursuant to tainer or 25 percent of the total inter- § 761.77. nal volume of all PCB Articles or PCB (vi) Has a TSCA PCB waste manage- Containers stored there, whichever is ment approval, which includes provi- greater. PCB/radioactive wastes are sions for storage, issued pursuant to not required to be stored in an area § 761.61(c) or § 761.62(c). with a minimum 6 inch high curbing. (c)(1) The following PCB Items may However, the floor and curbing must be stored temporarily in an area that still provide a containment volume does not comply with the requirements equal to at least two times the internal volume of the largest PCB Container or of paragraph (b) of this section for up 25 percent of the total internal volume to thirty days from the date of their of all PCB Containers stored there, removal from service, provided that a whichever is greater. notation is attached to the PCB Item (iii) No drain valves, floor drains, ex- or a PCB Container (containing the pansion joints, sewer lines, or other item) indicating the date the item was openings that would permit liquids to removed from service: flow from the curbed area; (i) Non-leaking PCB Articles and (iv) Floors and curbing constructed PCB Equipment; of Portland cement, concrete, or a con- (ii) Leaking PCB Articles and PCB tinuous, smooth, non-porous surface as Equipment if the PCB Items are placed defined at § 761.3, which prevents or in a non-leaking PCB Container that minimizes penetration of PCBs. contains sufficient sorbent materials (v) Not located at a site that is below to absorb any liquid PCBs remaining in the 100-year flood water elevation. the PCB Items;

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(iii) PCB Containers containing non- spections, maintenance, cleanup and liquid PCBs such as contaminated soil, disposal must be maintained in accord- rags, and debris; and ance with § 761.180(a) and (b). (iv) PCB containers containing liquid (6) Except as provided in paragraphs PCBs at concentrations of ≥50 ppm, (c)(6)(i) and (c)(6)(ii) of this section, provided a Spill Prevention, Control any container used for the storage of and Countermeasure Plan has been pre- liquid or non-liquid PCB waste shall be pared for the temporary storage area in in accordance with the requirements accordance with part 112 of this chap- set forth in the DOT Hazardous Mate- ter and the liquid PCB waste is in rials Regulations (HMR) at 49 CFR packaging authorized in the DOT Haz- parts 171 through 180. PCB waste not ardous Materials Regulations at 49 subject to the HMR (i.e., PCB wastes at CFR parts 171 through 180 or stationary concentrations of <20 ppm or <1 pound bulk storage tanks (including rolling of PCBs regardless of concentration) stock such as, but not limited to, tank- must be packaged in accordance with er trucks, as specified by DOT). Packaging Group III, unless other haz- (2) Non-leaking and structurally ards associated with the PCB waste undamaged PCB Large High Voltage cause it to require packaging in ac- Capacitors and PCB-Contaminated cordance with Packaging Groups I or Electrical Equipment that have not II. For purposes of describing PCB been drained of free flowing dielectric waste not subject to DOT’s HMR on a fluid may be stored on pallets next to manifest, one may use the term ‘‘Non- a storage facility that meets the re- DOT Regulated PCBs.’’ quirements of paragraph (b) of this sec- (i) Containers other than those meet- tion. PCB-Contaminated Electrical ing HMR performance standards may Equipment that has been drained of be used for storage of PCB/radioactive free flowing dielectric fluid is not sub- waste provided the following require- ject to the storage provisions of § 761.65. ments are met: Storage under this subparagraph will (A) Containers used for storage of liq- be permitted only when the storage fa- uid PCB/radioactive wastes must be cility has immediately available un- non-leaking. filled storage space equal to 10 percent (B) Containers used for storage of of the volume of capacitors and equip- non-liquid PCB/ radioactive wastes ment stored outside the facility. The must be designed to prevent the build- capacitors and equipment temporarily up of liquids if such containers are stored outside the facility shall be stored in an area meeting the contain- checked for leaks weekly. ment requirements of paragraph (3) Any storage area subject to the (b)(1)(ii) of this section, as well as all requirements of paragraph (b) or para- other applicable State or Federal regu- graph (c)(1) of this section shall be lations or requirements for control of marked as required in subpart C radioactive materials. § 761.40(a)(10). (C) Containers used to store both liq- (4) No item of movable equipment uid and non-liquid PCB/radioactive that is used for handling PCBs and PCB wastes must meet all regulations and Items in the storage units and that requirements pertaining to nuclear comes in direct contact with PCBs criticality safety. Acceptable container shall be removed from the storage unit materials currently include poly- area unless it has been decontaminated ethylene and stainless steel provided as specified in § 761.79. that the container material is chemi- (5) All PCB Items in storage shall be cally compatible with the wastes being checked for leaks at least once every 30 stored. Other containers may be used days. Any leaking PCB Items and their to store both liquid and non-liquid contents shall be transferred imme- PCB/radioactive wastes if the users are diately to properly marked non-leak- able to demonstrate, to the appropriate ing containers. Any spilled or leaked Regional Administrator and other ap- materials shall be immediately cleaned propriate regulatory authorities (i.e., up and the materials and residues con- Nuclear Regulatory Commission, De- taining PCBs shall be disposed of in ac- partment of Energy or the Department cordance with § 761.61. Records of in- of Transportation), that the use of such

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containers is protective of health and located by this date. Storage con- the environment as well as public tainers provided in paragraph (c)(7) of health and safety. this section, shall have a record that (ii) The following DOT specification includes for each batch of PCBs the containers that conform to the require- quantity of the batch and date the ments of 49 CFR, chapter I, subchapter batch was added to the container. The C in effect on September 30, 1991, may record shall also include the date, be used for storage and transportation quantity, and disposition of any batch activities that are not subject to DOT of PCBs removed from the container. regulation, and may be used on a tran- (9) Bulk PCB remediation waste or sitional basis as permitted at 49 CFR PCB bulk product waste may be stored 171.14. For liquid PCBs: Specification 5 at the clean-up site or site of genera- container without removable head, tion for 180 days subject to the fol- Specification 5B container without re- lowing conditions: movable head, Specification 6D over- (i) The waste is placed in a pile de- pack with Specification 2S or 2SL poly- signed and operated to control dis- ethylene containers, or Specification persal of the waste by wind, where nec- 17E container. For non-liquid PCBs: essary, by means other than wetting. Specification 5 container, Specification (ii) The waste must not generate 5B container, or Specification 17C con- leachate through decomposition or tainer. other reactions. (7) Stationary storage containers for (iii) The storage site must have: liquid PCBs can be larger than the containers specified in paragraph (c)(6) of (A) A liner that is designed, con- this section provided that: structed, and installed to prevent any (i) The containers are designed, con- migration of wastes off or through the structed, and operated in compliance liner into the adjacent subsurface soil, with Occupational Safety and Health ground water or surface water at any Standards, 29 CFR 1910.106, Flammable time during the active life (including and combustible liquids. Before using the closure period) of the storage site. these containers for storing PCBs, the The liner may be constructed of mate- design of the containers must be re- rials that may allow waste to migrate viewed to determine the effect on the into the liner. The liner must be: structural safety of the containers that (1) Constructed of materials that will result from placing liquids with have appropriate chemical properties the specific gravity of PCBs into the and sufficient strength and thickness containers (see 29 CFR to prevent failure due to pressure gra- 1910.106(b)(1)(i)(f)). dients (including static head and exter- (ii) The owners or operators of any nal hydrogeologic forces), physical con- facility using containers described in tact with the waste or leachate to paragraph (c)(7)(i) of this section, shall which they are exposed, climatic condi- prepare and implement a Spill Preven- tions, the stress of installation, and tion Control and Countermeasure the stress of daily operation. (SPCC) Plan as described in part 112 of (2) Placed upon a foundation or base this title. In complying with 40 CFR capable of providing support to the part 112, the owner or operator shall liner and resistance to pressure gra- read ‘‘oil(s)’’ as ‘‘PCB(s)’’ whenever it dients above and below the liner to pre- appears. The exemptions for storage vent failure of the liner due to settle- capacity, 40 CFR 112.1(d)(2), and the ment, compression, or uplift. amendment of SPCC plans by the Re- (3) Installed to cover all surrounding gional Administrator, 40 CFR 112.4, earth likely to be in contact with the shall not apply unless some fraction of waste. the liquids stored in the container are (B) A cover that meets the require- oils as defined by section 311 of the ments of paragraph (c)(9)(iii)(A) of this Clean Water Act. section, is installed to cover all of the (8) PCB Items shall be dated on the stored waste likely to be contacted item when they are removed from serv- with precipitation, and is secured so as ice for disposal. The storage shall be not to be functionally disabled by managed so that the PCB Items can be winds expected under normal seasonal

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meteorological conditions at the stor- maximum quantity of PCB waste that age site. will be handled at any one time at the (C) A run-on control system designed, facility. constructed, operated, and maintained (iii) The owner or operator of the such that: unit has certified compliance with the (1) It prevents flow onto the stored storage facility standards in para- waste during peak discharge from at graphs (b) and (c)(7) of this section. least a 25-year storm. (iv) The owner or operator has devel- (2) It collects and controls at least oped a written closure plan for the fa- the water volume resulting from a 24- cility that is deemed acceptable by the hour, 25-year storm. Collection and Regional Administrator (or the appro- holding facilities (e.g., tanks or basins) priate official at EPA Headquarters, if must be emptied or otherwise managed the commercial storage area is ancil- expeditiously after storms to maintain lary to a disposal facility permitted by design capacity of the system. (iv) The provisions of this paragraph an official at EPA Headquarters) under may be modified under § 761.61(c). the closure plan standards of paragraph (10) Owners or operators of storage (e) of this section. facilities shall establish and maintain (v) The owner or operator has in- records as provided in § 761.180. cluded in the application for final ap- (d) Approval of commercial storers of proval a demonstration of financial re- PCB waste. (1) All commercial storers sponsibility for closure that meets the of PCB waste shall have interim ap- financial responsibility standards of proval to operate commercial facilities paragraph (g) of this section. for the storage of PCB waste until Au- (vi) The operation of the storage fa- gust 2, 1990. Commercial storers of PCB cility will not pose an unreasonable waste are prohibited from storing any risk of injury to health or the environ- PCB waste at their facilities after Au- ment. gust 2, 1990 unless they have submitted (vii) The environmental compliance by August 2, 1990 a complete applica- history of the applicant, its principals, tion for a final storage approval under and its key employees may be deemed paragraph (d)(2) of this section. The pe- to constitute a sufficient basis for de- riod of interim approval shall continue nial of approval whenever in the judg- until EPA makes a final decision on ment of the appropriate EPA official the storage application at which time that history of environmental civil vio- such interim approval shall terminate. lations or criminal convictions evi- (2) The Regional Administrator for dences a pattern or practice of non- the region in which the storage facility compliance that demonstrates the ap- is located (or the appropriate official plicant’s unwillingness or inability to at EPA Headquarters, if the commer- achieve and maintain compliance with cial storage area is ancillary to a dis- the regulations. posal facility for which an official at EPA Headquarters has approval au- (3) Applicants for storage approvals thority)shall grant written, final ap- shall submit a written application that proval to engage in the commercial includes any relevant information storage of PCB waste upon a deter- bearing upon the qualifications of the mination that the criteria in paragraph facility’s principals and key employees (d)(2)(i) through (d)(2)(vii) of this sec- to engage in the business of commer- tion have been met by the applicant: cial storage of PCB wastes. This infor- (i) The applicant, its principals, and mation shall include, but is not limited its key employees responsible for the to: establishment or operation of the com- (i) The identification of the owner mercial storage facility are qualified to and the operator of the facility, includ- engage in the business of commercial ing all general partners of a partner- storage of PCB waste. ship, any limited partner of a partner- (ii) The facility possesses the capac- ship, any stockholder of a corporation ity to handle the quantity of PCB or any participant in any other type of waste which the owner or operator of business organization or entity who the facility has estimated will be the owns or controls, directly or indirectly,

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more than 5 percent of each partner- (4) The written approval issued by ship, corporation, or other business or- EPA shall include, but not be limited ganization and all officials of the facil- to, the following: ity who have direct management re- (i) The determination that the appli- sponsibility for the facility. cant has satisfied the requirements set (ii) The identification of the person forth in paragraph (d)(2) of this section, responsible for the overall operations and a brief statement setting forth the of the facility (i.e., a plant manager, basis for the determination. superintendent, or a person of similar (ii) Incorporation of the closure plan responsibility) and the supervisory em- submitted by the facility owner or op- ployees who are or will be responsible erator and approved by EPA. for the operation of the facility. (iii) A condition imposing a max- (iii) Information concerning the tech- imum PCB storage capacity which the nical qualifications and experience of facility shall not exceed during its PCB the persons responsible for the overall waste storage operations. The max- operation of the facility and the em- imum storage capacity imposed under ployees responsible for handling PCB this condition shall not be greater than waste or other wastes. the estimated maximum inventory of (iv) Information concerning any past PCB waste included in the owner’s or State or Federal environmental viola- operator’s application for final ap- tions involving the same business or proval. another business with which the prin- (iv) Such other conditions as deemed cipals or supervisory employees were affiliated directly that occurred within necessary by EPA to ensure that the 5 years preceding the date of submis- operations of the PCB storage facility sion and which relate directly to viola- will not pose an unreasonable risk of tions that resulted in either a civil injury to health or the environment. penalty (irrespective of whether the (5) Storage areas at transfer facilities matter was disposed of by an adjudica- are exempt from the requirement to tion or by a without prejudice settle- obtain approval as a commercial storer ment) or judgment of conviction of PCB waste under this paragraph, un- whether entered after trial or a plea, less the same PCB waste is stored at either of guilt or nolo contendere or these facilities for a period of time civil injunctive relief and involved greater than 10 consecutive days be- storage, disposal, transport, or other tween destinations. waste handling activities. (6) Storage areas at RCRA-permitted (v) A list of all companies currently facilities may be exempt from the sepa- owned or operated in the past by the rate TSCA storage approval require- principals or key employees identified ments in this paragraph (d) upon a in paragraphs (d)(3)(i) and (d)(3)(ii) of showing to the Regional Administra- this section that are or were directly tor’s satisfaction that the facility’s ex- or indirectly involved with waste han- isting RCRA closure plan is substan- dling activities. tially equivalent to this rule’s closure (vi) The owner’s or operator’s esti- plan standards, and that such facility’s mate of maximum PCB waste quantity closure cost estimate and financial as- to be handled at the facility. surance demonstration account for (vii) A written statement certifying maximum PCB waste inventories, and compliance with paragraph (b) or (c) of the requirements of paragraph (d)(3)(i) this section and containing a certifi- through (d)(3)(v) and (d)(3)(vii) of this cation as defined in § 761.3. section are met. A pay-in period of (viii) A written closure plan for the longer than 3 years after approval of facility, as described in paragraph (e) the storage facility pursuant to this of this section. rule, will be acceptable to EPA if that (ix) The current closure cost esti- pay-in period has already been estab- mate for the facility, as described in lished for a valid RCRA facility or pre- paragraph (f) of this section. viously approved TSCA facility. (x) A demonstration of financial re- (7) Storage areas ancillary to TSCA- sponsibility to close the facility, as de- approved disposal facilities may be ex- scribed in paragraph (g) of this section. empt from a separate facility approval

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provided all of the following conditions able risk to human health or the envi- are met: ronment. An acceptable closure plan (i) The current disposal approval con- must include, at a minimum, all of the tains an expiration date. following: (ii) The current disposal approval’s (i) A description of how the PCB stor- closure and financial responsibility age areas of the facility will be closed conditions specifically extend to stor- in a manner that eliminates the poten- age areas ancillary to disposal. tial for post-closure releases of PCBs (iii) The current disposal approval’s into the environment. closure and financial responsibility (ii) An identification of the max- conditions provide for annual adjust- imum extent of storage operations that ments for inflation, and for modifica- will be open during the active life of tion when changes in operation would the facility, including an identification affect closure costs. of the extent of PCB storage operations (iv) The current disposal approval at the facility relative to other wastes contains conditions on closure and fi- that will be handled at the facility. nancial responsibility that are at least (iii) An estimate of the maximum in- as stringent as those in paragraphs (e) ventory of PCB wastes that could be and (g) of this section. However, the handled at one time at the facility over provision for a 3-year closure trust its active life, and a detailed descrip- pay-in period, as specified in paragraph tion of the methods or arrangements to (g)(1)(i) of this section, would be be used during closure for removing, waived in a case in which an approved transporting, storing, or disposing of TSCA facility or RCRA facility that the facility’s inventory of PCB waste, covers PCB storage has a longer pay-in including an identification of any off- period for the trust. site facilities that will be used. (v) The current disposal approval sat- (iv) A detailed description of the isfies the requirements of paragraph steps needed to remove or decontami- (d)(3)(i) through (d)(3)(v) of this sec- nate PCB waste residues and contami- tion. nated containment system compo- (8) The approval of any existing nents, equipment, structures, and soils TSCA-approved disposal facility ancil- during closure in accordance with the lary to a commercial storage facility levels specified in the PCB Spills that is deficient in any of the condi- Cleanup Policy in subpart G of this tions of paragraph (d)(7)(i) through part, including a description of the (d)(7)(v) of this section shall be called methods for sampling and testing of in by the Regional Administrator (or surrounding soils, and the criteria for the appropriated official at EPA Head- determining the extent of removal or quarters, if approval was granted by an decontamination. official at EPA Headquarters). The ap- (v) A detailed description of other ac- proval shall be modified to meet the re- tivities necessary during the closure quirements of paragraph (d)(7) of this period to ensure that any post-closure section within 180 days of the effective releases of PCBs will not present un- date of this final rule, or a separate ap- reasonable risks to human health or plication for approval of the storage fa- the environment. This includes activi- cility may be submitted to the Re- ties such as ground-water monitoring, gional Administrator or the Director, run-on and run-off control, and facility Office of Resource Conservation and security. Recovery, in the cases where an official (vi) A schedule for closure of each at EPA Headquarters issued the ap- area of the facility where PCB waste is proval. stored or handled, including the total (e) Closure. (1) A commercial storer of time required to close each area of PCB PCB waste shall have a written closure waste storage or handling, and the plan that identifies the steps that the time required for any intervening clo- owner or operator of the facility shall sure activities. take to close the PCB waste storage fa- (vii) An estimate of the expected cility in a manner that eliminates the year of closure of the PCB waste stor- potential for post-closure releases of age areas, if a trust fund is opted for as PCBs which may present an unreason- the financial mechanism.

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(2) A written closure plan determined (ii) The date when a commercial stor- to be acceptable by EPA under this sec- er of PCB waste ‘‘expects to begin clo- tion shall become a condition of any sure’’ shall be no later than 30 days approval granted under paragraph (d) after the date on which the storage fa- of this section. cility received its final quantities of (3) A separate and new closure plan PCB waste. For good cause shown, EPA need not be submitted in cases where a may extend the date for commence- facility is currently covered by a TSCA ment of closure for an additional 30- approval or a RCRA permit, upon a day period. showing to the satisfaction of the Re- (iii) Within 90 days after receiving gional Administrator (or the appro- the final quantity of PCB waste for priate official at EPA Headquarters, if storage, a commercial storer of PCB the commercial storage area is ancil- waste shall remove all PCB waste in lary to a disposal facility for which an storage at the facility from the facility official at EPA Headquarters has ap- in accordance with the approved clo- proval authority) that the existing closure plan. For good cause shown, EPA sure plan is substantially equivalent to may approve a reasonable extension to closure plans required under para- the period for removal of the PCB graphs (d) through (g) of this section, waste. and that the plan adequately accounts (iv) A commercial storer of PCB for PCB waste inventories. waste shall complete closure activities (4) The commercial storer of PCB in accordance with the approved clo- waste shall submit a written request to sure plan and within 180 days after re- the Regional Administrator (or the Di- ceiving the final quantity of PCB waste rector, Office of Resource Conservation for storage at the facility. For good and Recovery, if an official at EPA cause shown, EPA may approve a rea- Headquarters approved the closure sonable extension to the closure period. (7) During the closure period, all con- plan) for a modification to its storage taminated system component equip- approval to amend its closure plan, ment, structures, and soils shall be dis- whenever: posed of in accordance with the dis- (i) Changes in ownership, operating posal requirements of subpart D of this plans, or facility design affect the ex- part, or, if applicable, decontaminated isting closure plan. in accordance with the levels specified (ii) There is a change in the expected in the PCB Spills Cleanup Policy at date of closure, if applicable. subpart G of this part. When PCB waste (iii) In conducting closure activities, is removed from the storage facility unexpected events require a modifica- during closure, the owner or operator tion of the approved closure plan. becomes a generator of PCB waste sub- (5) The Regional Administrator or ject to the generator requirements of the Director, appropriate official at subpart J of this part. EPA Headquarters, if an official at (8) Within 60 days of completion of EPA Headquarters approved the clo- closure of each facility for the storage sure plan, may modify the existing clo- of PCB waste, the commercial storer of sure plan under the conditions de- PCB waste shall submit to the Re- scribed in paragraph (e)(4) of this sec- gional Administrator (or the Director, tion. Office of Resource Conservation and (6) Commercial storers of PCB waste Recovery, if an official at EPA Head- shall comply with the following closure quarters approved the closure plan), by schedule: registered mail, a certification that (i) The commercial storer shall no- the PCB storage facility has been tify in writing the Regional Adminis- closed in accordance with the approved trator or the Director, Office of Re- closure plan. The certification shall be source Conservation and Recovery, if signed by the owner or operator and by an official at EPA Headquarters ap- an independent registered professional proved the closure plan, at least 60 engineer. days prior to the date on which final (f) Closure cost estimate. (1) A commer- closure of its PCB storage facility is cial storer of PCB wastes shall have a expected to begin. detailed estimate, in current dollars, of

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the cost of closing the facility in ac- Product is included in a monthly publi- cordance with its approved closure cation titled Economic Indicators, which plan. The closure cost estimate shall be is available from the Superintendent of in writing, be certified by the person Documents, Government Printing Of- preparing it (using the certification de- fice, Washington, DC 20402. The infla- fined in § 761.3) and comply with all of tion factor used in the latter method is the following criteria: the result of dividing the latest pub- (i) The closure cost estimate shall lished annual Deflator by the Deflator equal the cost of final closure at the for the previous year. The adjustment point in the PCB storage facility’s ac- to the closure cost estimate is then tive life when the extent and manner of made by multiplying the most recent PCB storage operations would make closure cost estimate by the latest in- closure the most expensive, as indi- flation factor. cated by the facility’s closure plan. (3) Where EPA approves a modifica- (ii) The closure cost estimate shall be tion to the facility’s closure plan, and based on the costs to the owner or op- that modification increases the cost of erator of hiring a third party to close closure, the owner or operator shall re- the facility, and the third party shall vise the closure cost estimate no later not be either a corporate parent or sub- than 30 days after the modification is sidiary of the owner or operator, or approved. Any such revision shall also member in joint ownership of the facil- be adjusted for inflation in accordance ity. with paragraph (f)(2) of this section. (iii) The owner or operator shall in- (4) The owner or operator of the facil- clude in the estimate the current mar- ity shall keep at the facility during its ket costs for off-site commercial dis- operating life the most recent closure posal of the facility’s maximum esti- cost estimate, including any adjust- mated inventory of PCB wastes, except ments resulting from inflation or from that on-site disposal costs may be used modifications to the closure plan. if on-site disposal capacity will exist at (g) Financial assurance for closure. A the facility at all times over the life of commercial storer of PCB waste shall the PCB storage facility. establish financial assurance for clo- (iv) The closure cost estimate may sure of each PCB storage facility that not incorporate any salvage value that he owns or operates. In establishing fi- may be realized with the sale of wastes, nancial assurance for closure, the com- facility structures or equipment, land, mercial storer of PCB waste may or other assets associated with the fa- choose from the following financial as- cility at the time of closure. surance mechanisms or any combina- (2) During the active life of the PCB tion of mechanisms: storage facility, the commercial storer (1) The ‘‘closure trust fund,’’ as speci- of PCB waste shall adjust annually for fied in § 264.143(a) of this chapter, ex- inflation the closure cost estimate cept for paragraph (a)(3) of § 264.143. For within 60 days prior to the anniversary purposes of this paragraph, the fol- date of the establishment of the finan- lowing provisions also apply: cial instruments used to demonstrate (i) Payments into the trust fund shall financial responsibility for closure, ex- be made annually by the owner or oper- cept that owners or operators who use ator over the remaining operating life the financial test or corporate guar- of the facility as estimated in the clo- antee shall adjust their closure cost es- sure plan, or over 3 years, whichever timates for inflation within 30 days period is shorter. This period of time is after the close of the storer’s fiscal hereafter referred to as the ‘‘pay-in pe- year. The adjustment may be made by riod.’’ For an existing facility, the first recalculating the maximum costs of payment must be made within 30 cal- closure in current dollars, or by using endar days after EPA has notified the an inflation factor derived from the facility of its conditional approval. In- most recent Implicit Price Deflator for terim approval to operate is canceled Gross National Product published by and the application is denied if EPA the U.S. Department of Commerce in does not receive verification that the its Survey of Current Business. The Im- payment was made in that 30-day pe- plicit Price Deflator for Gross National riod.

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(ii) For a new facility, the first pay- to submit a trust agreement under this ment into the closure trust fund shall subpart. be made before EPA grants final ap- (2) The ‘‘surety bond guaranteeing proval of the application and before the payment into a closure trust fund,’’ as facility may accept the initial ship- specified in § 264.143(b) of this chapter, ment of PCB waste for commercial including the use of the surety bond in- storage. A receipt from the trustee strument specified at § 264.151(b) of this shall be submitted by the owner or op- chapter and the standby trust specified erator to the Regional Administrator at § 264.143(b)(3) of this chapter. The use (or the Director, Office of Resource of the surety bonds, surety bond instru- Conservation and Recovery, if the comments, and standby trust agreements mercial storage area is ancillary to a specified in §§ 264.143(b) and 264.151(b) of disposal facility approved by an official this chapter shall be deemed to be in at EPA Headquarters) before this ini- compliance with this subpart. tial delivery of PCB waste. The first (3)(i) The ‘‘surety bond guaranteeing payment shall be at least equal to the performance of closure,’’ as specified at current closure cost estimate, divided § 264.143(c) of this chapter, except for by the number of years in the pay-in paragraph (c)(5) of § 264.143 of this chap- period, except as provided in paragraph ter. The submission and use of the sur- (g)(7) of this section for multiple mech- ety bond instrument specified at anisms. Subsequent payments shall be § 264.151(c) of this chapter and the made no later than 30 days after each standby trust specified at § 264.143(c)(3) of this chapter shall be deemed to be in anniversary date of the first payment. compliance with the requirements The amount of each subsequent pay- under this subpart relating to the use ment shall be determined by sub- of surety bonds and standby trust tracting the current value of the trust funds. fund from the current closure cost esti- (ii) For the purposes of this para- mate, and dividing this difference by graph, and under the terms of the bond, the number of years remaining in the the surety shall become liable on the pay-in period. bond obligation when the owner or op- (iii) If an owner or operator of a facil- erator fails to perform as guaranteed ity existing on the effective date of by the bond. Liability is established by this paragraph establishes a trust fund a final administrative determination to meet the financial assurance re- pursuant to section 16 of TSCA that quirements of this paragraph, and the the owner or operator has failed to per- value of the trust fund is less than the form final closure in accordance with current closure cost estimate when a the closure plan and other approval or final approval is granted for the facil- regulatory requirements when required ity, the amount of the current closure to do so. cost estimate still to be paid into the (4)(i) The ‘‘closure letter of credit’’ trust fund shall be paid in over the specified in § 264.143(d) of this chapter, pay-in period as defined in paragraph except for paragraph (d)(8). The sub- (g)(1)(i) of this section. Payments shall mission and use of the irrevocable let- continue to be made no later than 30 ter of credit instrument specified in days after each anniversary date of the § 264.151(d) of this chapter and the first payment made into the trust fund. standby trust specified in § 264.143(d)(3) The amount of each payment shall be of this chapter shall be deemed to be in determined by subtracting the current compliance with the requirements of value of the trust fund from the cur- this subpart relating to the use of let- rent closure cost estimate, and divid- ters of credit and standby trust funds. ing this difference by the number of (ii) For the purposes of this para- years remaining in the pay-in period. graph, the Regional Administrator (or (iv) The submission of a trust agree- the appropriate official at EPA Head- ment with the wording specified in quarters, if the commercial storage § 264.151(a)(1) of this chapter, including area is ancillary to a disposal facility any reference to hazardous waste man- for which an official at EPA Head- agement facilities, shall be deemed to quarters has approval authority) may be in compliance with the requirement draw on the letter of credit following a

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final administrative determination fied of the completion of the modifica- pursuant to section 16 of TSCA that tion, but prior to the use of the modi- the owner or operator has failed to per- fied portion of the facility. form final closure in accordance with (h) Release of owner or operator. With- the closure plan and other approval or in 60 days after receiving certifications regulatory requirements when required from the owner or operator and an to do so. independent registered professional en- (5) ‘‘Closure insurance,’’ as specified gineer that final closure has been com- in § 264.143(e) of this chapter, utilizing pleted in accordance with the approved the certificate of insurance for closure closure plan, EPA will notify the owner specified at § 264.151(e) of this chapter. or operator in writing that the owner The use of closure insurance as speci- or operator is no longer required by fied in § 264.143(e) of this chapter and this section to maintain financial as- the submission and use of the certifi- surance for final closure of the facility, cate of insurance specified in unless EPA has reason to believe that § 264.151(e) of this chapter shall be final closure has not been completed in deemed to be in compliance with the accordance with the approved closure requirements of this subpart relating plan. EPA shall provide the owner or to the use of closure insurance. (6) The ‘‘financial test and corporate operator with a detailed written state- guarantee for closure,’’ as described in ment stating the reasons why EPA § 264.143(f) of this chapter, including a shall provide the owner or operator letter signed by the owner’s or opera- with a detailed written statement stat- tor’s chief financial officer as specified ing the reasons why he believed closure at § 264.151(f) of this chapter and, if ap- was not conducted in accordance with plicable, the written corporate guar- the approved closure plan. antee specified at § 264.151(h) of this (i) Laboratories and samples. (1) A lab- chapter. The use of the financial test oratory is conditionally exempt from and corporate guarantee specified in the notification and approval require- § 264.143(f) of this chapter, the submis- ments for a commercial storer under sion and use of the letter specified in § 761.65 (d) through (h) when it stores § 264.151(f) of this chapter, and the subsamples held for disposal in a facility mission and use of the written cor- that complies with the standards in porate guarantee specified at § 761.65 (b)(1)(i) through (b)(1)(iv). § 264.151(h) of this chapter shall be (2) A laboratory sample is exempt deemed to be in compliance with the from the manifesting requirements in requirements of this subpart relating § 761.208 when: to the use of financial tests and cor- (i) The sample is being transported to porate guarantees. a laboratory for the purpose of testing. (7) The corporate guarantee as speci- (ii) The sample is being transported fied in § 264.143(f)(10) of this chapter. back to the sample collector after test- (8) The use of multiple financial ing. mechanisms, as specified in § 264.143(g) (iii) The sample is being stored by of this chapter is permitted. the sample collector before transport (9) A modification to a facility stor- to a laboratory for testing. ing PCB waste that increases the max- (iv) The sample is being stored in a imum storage capacity indicated in the laboratory before testing. permit requires that a new financial assurance mechanism be established or (v) The sample is being stored in a an existing one be amended. When such laboratory after testing but before it is a modification occurs, the Director of returned to the sample collector. the Federal or State issuing authority (vi) The sample is being stored tem- must be notified in writing no later porarily in the laboratory after testing than 30 days from the completion of for a specific purpose (for example, the modification. The new or revised fi- until conclusion of a court case or en- nancial assurance mechanism must be forcement action where further testing established and activated no later than of the sample may be necessary). 30 days after the Director of the Fed- (3) In order to qualify for the exemp- eral or State issuing authority is noti- tion in paragraph (i)(2)(i) and (i)(2)(ii)

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of this section, a sample collector ship- lapse in financial assurance for the ping samples to a laboratory and a lab- transferred facility. oratory returning samples to a sample (2) The transferor or transferee has collector must: resolved any deficiencies (e.g., tech- (i) Comply with applicable U.S. De- nical operations, closure plans, cost es- partment of Transportation (DOT) or timates, etc.) the Agency has identified U.S. Postal Service (USPS) shipping rein the transferor’s application. quirements, found respectively in 49 (k) States and the Federal Government. CFR 173.345 and U.S. Postal Regula- States and the Federal Government are tions 652.2 and 652.3. exempt from the requirements of para- (ii) Assure that the following infor- graphs (f) and (g) of this section. mation accompanies the sample: (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C. (A) The sample collector’s name, 2605) mailing address, and telephone number. [44 FR 31542, May 31, 1979. Redesignated at 47 (B) The laboratory’s name, mailing FR 19527, May 6, 1982, and amended at 47 FR address, and telephone number. 37359, Aug. 8, 1982; 49 FR 28191, July 10, 1984; 53 FR 12524, Apr. 15, 1988; 54 FR 52746, Dec. 21, (C) The quantity of the sample. 1989; 55 FR 695, Jan. 8, 1990; 55 FR 26205, June (D) The date of shipment. 27, 1990; 58 FR 15809, Mar. 24, 1993; 58 FR 34205, (E) A description of the sample. June 23, 1993; 58 FR 59374, Nov. 9, 1993; 63 FR (iii) Package the sample so that it 35439, 35452, June 29, 1998; 72 FR 57239, 57240 does not leak, spill, or vaporize from Oct. 9, 2007; 74 FR 30232, June 25, 2009] its packaging. § 761.70 Incineration. (4) When the concentration of the PCB sample has been determined, and This section applies to facilities used its use is terminated, the sample must to incinerate PCBs required to be in- be properly disposed. A laboratory cinerated by this part. must either manifest the PCB waste to (a) Liquid PCBs. An incinerator used a disposer or commercial storer, as re- for incinerating PCBs shall be approved quired under § 761.208, retain a copy of by EPA pursuant to paragraph (d) of each manifest, as required under this section. Requests for approval of § 761.209, and follow up on exception re- incinerators to be used in more than porting, as required under § 761.215 (a) one region must be submitted to the and (b), or return the sample to the Director, Office of Resource Conserva- sample collector who must then prop- tion and Recovery, except for research erly dispose of the sample. If the lab- and development involving less than oratory returns the sample to the sam- 500 pounds of PCB material (see ple collector, the laboratory must com- § 761.60(i)(2)). Requests for approval of ply with the shipping requirements set incinerators to be used in only one re- forth in paragraph (i)(3)(i) through gion must be submitted to the appro- (i)(3)(iii) of this section. priate Regional Administrator. The in- (j) Changes in ownership or operational cinerator shall meet all of the require- control of a commercial storage facility. ments specified in paragraphs (a)(1) The date of transfer of interim status through (9) of this section, unless a or final approval shall be the date the waiver from these requirements is ob- EPA Regional Administrator (or appro- tained pursuant to paragraph (d)(5) of priate official at EPA Headquarters) this section, In addition, the inciner- provides written approval of the trans- ator shall meet any other requirements fer. EPA will provide a final written which may be prescribed pursuant to decision within 90 days of receipt of the paragraph (d)(4) of this section. complete new or amended application. (1) Combustion criteria shall be ei- The Agency will approve the transfer if ther of the following: the following conditions are met: (i) Maintenance of the introduced liq- (1) The transferee has established fi- uids for a 2-second dwell time at 1200 °C nancial assurance for closure pursuant (±100 °C) and 3 percent excess oxygen in to paragraph (g) of this section using a the stack gas; or mechanism effective as of the date of (ii) Maintenance of the introduced final approval so that there will be no liquids for a 11⁄2 second dwell time at

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1600 °C(±100 °C) and 2 percent excess ox- (8) The flow of PCBs to the inciner- ygen in the stack gas. ator shall stop automatically when any (2) Combustion efficiency shall be at one or more of the following conditions least 99.9 percent computed as follows: occur, unless a contingency plan is submitted by the incinerator owner or op- Combustion efficiency = [Cco /(Cco + 2 2 erator and approved by the Regional Cco)]100 Administrator or appropriate official where at EPA Headquarters. The contingency

Cco2=Concentration of carbon dioxide. plan indicates what alternative meas- Cco=Concentration of carbon monoxide. ures the incinerator owner or operator would take if any of the following con- (3) The rate and quantity of PCBs ditions occur: which are fed to the combustion sys- (i) Failure of monitoring operations tem shall be measured and recorded at specified in paragraph (a)(7) of this sec- regular intervals of no longer than 15 tion; minutes. (ii) Failure of the PCB rate and quan- (4) The temperatures of the inciner- tity measuring and recording equip- ation process shall be continuously ment specified in paragraph (a)(3) of measured and recorded. The combus- this section; or tion temperature of the incineration (iii) Excess oxygen falls below the process shall be based on either direct percentage specified in paragraph (a)(1) (pyrometer) or indirect (wall thermo- of this section. couple-pyrometer correlation) tem- (9) Water scrubbers shall be used for perature readings. HCl control during PCB incineration (5) The flow of PCBs to the inciner- and shall meet any performance re- ator shall stop automatically whenever quirements specified by EPA. Scrubber the combustion temperature drops effluent shall be monitored and shall below the temperatures specified in comply with applicable effluent or paragraph (a)(1) of this section. pretreatment standards, and any other (6) Monitoring of stack emission State and Federal laws and regula- products shall be conducted: tions. An alternate method of HCl con- (i) When an incinerator is first used trol may be used if the alternate meth- for the disposal of PCBs under the pro- od has been approved by EPA. (The HCl visions of this regulation; neutralizing capability of cement kilns (ii) When an incinerator is first used is considered to be an alternate meth- for the disposal of PCBs after the incin- od.) erator has been modified in a manner (b) Nonliquid PCBs. An incinerator which may affect the characteristics of used for incinerating nonliquid PCBs, the stack emission products; and PCB Articles, PCB Equipment, or PCB (iii) At a minimum such monitoring Containers shall be approved by EPA shall be conducted for the following pa- pursuant to paragraph (d) of this sec- rameters: tion. Requests for approval of inciner- (a) O2; (b) CO; (c) CO2; (d) Oxides of ators to be used in more than one re- Nitrogen (NOX); (e) Hydrochloric Acid gion must be submitted to the Direc- (HCl); (f) Total Chlorinated Organic tor, Office of Resource Conservation Content (RCl); (g) PCBs; and (h) Total and Recovery except for research and Particulate Matter. development involving less that 500 (7) At a minimum monitoring and re- pounds of PCB material (see cording of combustion products and in- § 761.60(i)(2)). Requests for approval of cineration operations shall be con- incinerators to be used in only one re- ducted for the following parameters gion must be submitted to the appro- whenever the incinerator is incin- priate Regional Administrator. The in- erating PCBs: cinerator shall meet all of the require- (i) O2; (ii) CO; and (iii) CO2. The moni- ments specified in paragraphs (b)(1) toring for O2 and CO shall be contin- and (2) of this section unless a waiver uous. The monitoring for CO2 shall be from these requirements is obtained periodic, at a frequency specified by pursuant to paragraph (d)(5) of this sec- the Regional Administrator or appro- tion. In addition, the incinerator shall priate official at EPA Headquarters. meet any other requirements that may

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be prescribed pursuant to paragraph mation shall be restricted to the types (d)(4) of this section. of information required in paragraphs (1) The mass air emissions from the (d)(1)(i) through (vii) of this section. incinerator shall be no greater than (ii) If EPA determines that a trail 0.001g PCB/kg of the PCB introduced burn must be held, the person who sub- into the incinerator. mitted the report described in para- (2) The incinerator shall comply with graph (d)(1) of this section shall submit the provisions of paragraphs (a)(2), (3), to the Regional Administrator or the (4), (6), (7), (8)(i) and (ii), and (9) of this Director, Office of Resource Conserva- section. tion and Recovery a detailed plan for (c) Maintenance of data and records. conducting and monitoring the trail All data and records required by this burn. At a minimum, the plan must in- section shall be maintained in accord- clude: ance with § 761.180, Records and moni- (A) Date trial burn is to be con- toring. ducted; (d) Approval of incinerators. Prior to (B) Quantity and type of PCBs and the incineration of PCBs and PCB PCB Items to be incinerated; Items the owner or operator of an in- (C) Parameters to be monitored and cinerator shall receive the written ap- location of sampling points; proval of the Agency Regional Admin- (D) Sampling frequency and methods istrator for the region in which the in- and schedules for sample analyses; and cinerator is located, or the appropriate (E) Name, address, and qualifications official at EPA Headquarters. Approval of persons who will review analytical from the appropriate official at EPA results and other pertinent data, and Headquarters may be effective in all who will perform a technical evalua- ten EPA regions. Such approval shall tion of the effectiveness of the trial be obtained in the following manner: burn. (1) Application. The owner or operator (iii) Following receipt of the plan de- shall submit to the Regional Adminis- scribed in paragraph (d)(2)(ii) of this trator or the Director, Office of Re- section, EPA will approve the plan, resource Conservation and Recovery an quire additions or modifications to the application which contains: plan, or disapprove the plan. If the plan (i) The location of the incinerator; is disapproved, EPA will notify the per- (ii) A detailed description of the in- son who submitted the plan of such dis- cinerator including general site plans approval, together with the reasons and design drawings of the incinerator; why it is disapproved. That person may (iii) Engineering reports or other in- thereafter submit a new plan in accord- formation on the anticipated performance with paragraph (d)(2)(ii) of this ance of the incinerator; section. If the plan is approved (with (iv) Sampling and monitoring equip- any additions or modifications which ment and facilities available; EPA may prescribe), EPA will notify (v) Waste volumes expected to be in- the person who submitted the plan of cinerated; the approval. Thereafter, the trial burn (vi) Any local, State, or Federal per- shall take place at a date and time to mits or approvals; and be agreed upon between EPA and the (vii) Schedules and plans for com- person who submitted the plan. plying with the approval requirements (3) Other information. In addition to of this regulation. the information contained in the re- (2) Trial burn. (i) Following receipt of port and plan described in paragraphs the application described in paragraph (d)(1) and (2) of this section, EPA may (d)(1) of this section, EPA shall deter- require the owner or operator to sub- mine if a trial burn is required and no- mit any other information that the tify the person who submitted the re- EPA finds to be reasonably necessary port whether a trial burn of PCBs and to determine whether an incinerator PCB Items must be conducted. EPA shall be approved.

may require the submission of any NOTE: The Regional Administrator will other information that EPA finds to be have available for review and inspection an reasonably necessary to determine the Agency manual containing information on need for a trial burn. Such other infor- sampling methods and analytical procedures

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for the parameters required in § 761.70(a) (3), (8) Transfer of property. Any person (4), (6), and (7) plus any other parameters he/ who owns or operates an approved in- she may determine to be appropriate. Owners cinerator must notify EPA at least 30 or operators are encouraged to review this days before transferring ownership in manual prior to submitting any report required in § 761.70. the incinerator or the property it stands upon, or transferring the right (4) Contents of approval. (i) Except as to operate the incinerator. The trans- provided in paragraph (d)(5) of this sec- feror must also submit to EPA, at least tion, the Regional Administrator or 30 days before such transfer, a nota- the appropriate official at EPA Head- rized affidavit signed by the transferee quarters may not approve an inciner- which states that the transferee will ator for the disposal of PCBs and PCB abide by the transferor’s EPA inciner- Items unless he finds that the incinerator approval. Within 30 days of receiv- ator meets all of the requirements of ing such notification and affidavit, paragraphs (a) and/or (b) of this sec- EPA will issue an amended approval tion. substituting the transferee’s name for (ii) In addition to the requirements of the transferor’s name, or EPA may re- paragraphs (a) and/or (b) of this sec- quire the transferee to apply for a new tion, EPA may include in an approval incinerator approval. In the latter any other requirements that EPA finds case, the transferee must abide by the are necessary to ensure that operation transferor’s EPA approval until EPA of the incinerator does not present an issues the new approval to the trans- unreasonable risk of injury to health feree. or the environment from PCBs. Such requirements may include a fixed pe- (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C. 2605) riod of time for which the approval is valid. [44 FR 31542, May 31, 1979. Redesignated at 47 (5) Waivers. An owner or operator of FR 19527, May 6, 1982, and amended at 48 FR 13185, Mar. 30, 1983; 49 FR 28191, July 10, 1984; the incinerator may submit evidence to 53 FR 12524, Apr. 15, 1988; 58 FR 15809, Mar. 24, the Regional Administrator or the Di- 1993; 63 FR 35439, June 29, 1998; 72 FR 57240, rector, Office of Resource Conservation Oct. 9, 2007; 74 FR 30233, June 25, 2009] and Recovery that operation of the incinerator will not present an unreason- § 761.71 High efficiency boilers. able risk of injury to health or the en- (a) To burn mineral oil dielectric vironment from PCBs, when one or fluid containing a PCB concentration more of the requirements of paragraphs of ≥50 ppm, but <500 ppm: (a) and/or (b) of this section are not (1) The boiler shall comply with the met. On the basis of such evidence and following criteria: any other available information, EPA (i) The boiler is rated at a minimum may, in its discretion, find that any re- of 50 million BTU hours. quirement of paragraphs (a) and (b) of (ii) If the boiler uses natural gas or this section is not necessary to protect oil as the primary fuel, the carbon against such a risk, and may waive the monoxide concentration in the stack is requirements in any approval for that ≤50 ppm and the excess oxygen is at incinerator. Any finding and waiver least 3 percent when PCBs are being under this paragraph must be stated in burned. writing and included as part of the ap- (iii) If the boiler uses coal as the pri- proval. mary fuel, the carbon monoxide con- (6) Persons approved. An approval will centration in the stack is ≤100 ppm and designate the persons who own and who the excess oxygen is at least 3 percent are authorized to operate the inciner- when PCBs are being burned. ator, and will apply only to such per- (iv) The mineral oil dielectric fluid sons, except as provided in paragraph does not comprise more than 10 percent (d)(8) of this section. (on a volume basis) of the total fuel (7) Final approval. Approval of an in- feed rate. cinerator will be in writing and signed (v) The mineral oil dielectric fluid is by the appropriate EPA official. The not fed into the boiler unless the boiler approval will state all requirements is operating at its normal operating applicable to the approved incinerator. temperature (this prohibits feeding

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these fluids during either start up or (3) When burning mineral oil dielec- shut down operations). tric fluid, the boiler must operate at a (vi) The owner or operator of the level of output no less than the output boiler: at which the measurements required (A) Continuously monitors and under paragraph (a)(2)(iii) of this sec- records the carbon monoxide con- tion were taken. centration and excess oxygen percent- (4) Any person burning mineral oil di- age in the stack gas while burning min- electric fluid in a boiler obtains the eral oil dielectric fluid; or following information and retains the (B) If the boiler will burn <30,000 gal- information for 5 years at the boiler lo- lons of mineral oil dielectric fluid per cation: year, measures and records the carbon (i) The data required to be collected monoxide concentration and excess ox- under paragraphs (a)(1)(vi) and (vii) of ygen percentage in the stack gas at this section. regular intervals of no longer than 60 (ii) The quantity of mineral oil di- minutes while burning mineral oil dielectric fluid burned in the boiler each electric fluid. month. (vii) The primary fuel feed rates, mineral oil dielectric fluid feed rates, (b) To burn liquids, other than min- and total quantities of both primary eral oil dielectric fluid, containing a ≥ fuel and mineral oil dielectric fluid fed PCB concentration of 50 ppm, but <500 to the boiler are measured and re- ppm: corded at regular intervals of no longer (1) The boiler shall comply with the than 15 minutes while burning mineral following criteria: oil dielectric fluid. (i) The boiler is rated at a minimum (viii) The carbon monoxide con- of 50 million BTU/hour. centration and the excess oxygen per- (ii) If the boiler uses natural gas or centage are checked at least once oil as the primary fuel, the carbon every hour that mineral oil dielectric monoxide concentration in the stack is fluid is burned. If either measurement ≤50 ppm and the excess oxygen is at falls below the levels specified in this least 3 percent when PCBs are being section, the flow of mineral oil dielec- burned. tric fluid to the boiler shall be stopped (iii) If the boiler uses coal as the pri- immediately. mary fuel, the carbon monoxide con- (2) Thirty days before any person centration in the stack is ≤100 ppm and burns mineral oil dielectric fluid in the the excess oxygen is at least 3 percent boiler, the person gives written notice when PCBs are being burned. to the EPA Regional Administrator for (iv) The waste does not comprise the EPA Region in which the boiler is more than 10 percent (on a volume located and that the notice contains basis) of the total fuel feed rate. the following information: (v) The waste is not fed into the boil- (i) The name and address of the er unless the boiler is operating at its owner or operator of the boiler and the address of the boiler. normal operating temperature (this (ii) The boiler rating in units of BTU/ prohibits feeding these fluids during ei- hour. ther start up or shut down operations). (iii) The carbon monoxide concentra- (vi) The owner or operator of the tion and the excess oxygen percentage boiler must: in the stack of the boiler when it is op- (A) Continuously monitor and record erated in a manner similar to the man- the carbon monoxide concentration ner in which it will be operated when and excess oxygen percentage in the mineral oil dielectric fluid is burned. stack gas while burning waste fluid; or (iv) The type of equipment, appa- (B) If the boiler will burn <30,000 gal- ratus, and procedures to be used to lons of waste fluid per year, measure control the feed of mineral oil dielec- and record the carbon monoxide con- tric fluid to the boiler and to monitor centration and excess oxygen percent- and record the carbon monoxide con- age in the stack gas at regular inter- centration and excess oxygen percent- vals of no longer than 60 minutes while age in the stack. burning waste fluid.

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(vii) The primary fuel feed rate, using either ASTM D-2709-88 or ASTM waste fluid feed rate, and total quan- D-1796-83 (Reapproved 1990), ash con- tities of both primary fuel and waste tent using ASTM D-482-87, calorific fluid fed to the boiler must be meas- value using ASTM D-240-87, carbon res- ured and recorded at regular intervals idue using either ASTM D-2158-89 or of no longer than 15 minutes while ASTM D-524-88, and flash point using burning waste fluid. ASTM D-93-90. (viii) The carbon monoxide con- (vii) The quantity of wastes esti- centration and the excess oxygen per- mated to be burned in a 30–day period. centage must be checked at least once (viii) An explanation of the proce- every hour that the waste is burned. If dures to be followed to ensure that either measurement falls below the burning the waste will not adversely levels specified in either (a)(1)(ii) or affect the operation of the boiler such (a)(1)(iii) of this section, the flow of that combustion efficiency will de- waste to the boiler shall be stopped im- crease. mediately. (3) On the basis of the information in (2) Prior to any person burning these paragraph (b)(2) of this section and any liquids in the boiler, approval must be other available information, the Re- obtained from the EPA Regional Ad- gional Administrator may, at his/her ministrator for the EPA Region in discretion, find that the alternate dis- which the boiler is located and any per- posal method will not present an un- sons seeking such approval must sub- reasonable risk of injury to health or mit to the EPA Regional Adminis- the environment and approve the use of trator a request containing at least the the boiler. following information: (4) When burning PCB wastes, the (i) The name and address of the boiler must operate at a level of output owner or operator of the boiler and the no less than the output at which the address of the boiler. measurements required under para- (ii) The boiler rating in units of BTU/ graph (b)(2)(iii) of this section were hour. taken. (iii) The carbon monoxide concentra- (5) Any person burning liquids in tion and the excess oxygen percentage boilers approved as provided in para- in the stack of the boiler when it is op- graph (b)(3) of this section, must obtain erated in a manner similar to the man- the following information and retain ner in which it will be operated when the information for 5 years at the boil- low concentration PCB liquid is er location: burned. (i) The data required to be collected (iv) The type of equipment, appa- in paragraphs (b)(1)(vi) and (b)(1)(vii) of ratus, and procedures to be used to this section. control the feed of mineral oil dielec- (ii) The quantity of low concentra- tric fluid to the boiler and to monitor tion PCB liquid burned in the boiler and record the carbon monoxide con- each month. centration and excess oxygen percent- (iii) The analysis of the waste re- age in the stack. quired by paragraph (b)(2)(vi) of this (v) The type of waste to be burned section taken once a month for each (e.g., hydraulic fluid, contaminated month during which low concentration fuel oil, heat transfer fluid, etc.). PCB liquid is burned in the boiler. (vi) The concentration of PCBs and of [63 FR 35454, June 29, 1998] any other chlorinated hydrocarbon in the waste and the results of analyses § 761.72 Scrap metal recovery ovens using the American Society of Testing and smelters. and Materials (ASTM) methods as fol- Any person may dispose of residual lows: Carbon and hydrogen content PCBs associated with PCB-Contami- using ASTM D-3178-84, nitrogen con- nated articles regulated for disposal tent using ASTM E-258-67 (Reapproved under § 761.60(b), metal surfaces in PCB 1987), sulfur content using ASTM D- remediation waste regulated under 2784-89, ASTM D-1266-87, or ASTM D- § 761.61, or metal surfaces in PCB bulk 129-64, chlorine content using ASTM D- product waste regulated under 808-87, water and sediment content §§ 761.62(a)(6) and 761.79(c)(6), from

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which all free-flowing liquids have been (9) A measurement of the tempera- removed: ture in the secondary chamber at the (a) In a scrap metal recovery oven: time the primary chamber starts heat- (1) The oven shall have at least two ing must be taken, recorded and re- enclosed (i.e., negative draft, no fugi- tained at the facility for 3 years from tive emissions) interconnected cham- the date each charge is introduced into bers. the primary chamber. (2) The equipment with all free-flow- (b) By smelting: ing liquid removed shall first be placed (1) The operating temperature of the in the primary chamber at room tem- hearth must be at least 1,000 °C at the perature. time it is charged with any PCB-Con- (3) The primary chamber shall oper- taminated non-porous surface. ate at a temperature between 537 °C (2) Each charge containing a PCB- and 650 °C for a minimum of 21⁄2 hours and reach a minimum temperature of Contaminated item must be added into ≥ ° 650 °C (1,202 °F) once during each heat- molten metal or a hearth at 1,000 C. ing cycle or batch treatment of (3) Successive charges may not be in- unheated, liquid-free equipment. troduced into the hearth in less than (4) Heated gases from the primary 15–minute intervals. chamber must feed directly into the (4) The smelter must operate in com- secondary chamber (i.e., afterburner) pliance with any applicable emissions which must operate at a minimum standards in part 60 of this chapter. temperature of 1,200 °C (2,192 °F) with (5) The smelter must have an oper- at least a 3 percent excess oxygen and ational device which accurately meas- a retention time of 2.0 seconds with a ures directly or indirectly, the tem- minimum combustion efficiency of 99.9 perature in the hearth. percent according to the definition in (6) Take, record and retain at the dis- § 761.70(a)(2). posal facility for 3 years from the date (5) Heating of the primary chamber each charge is introduced, a reading of shall not commence until the sec- the temperature in the hearth at the ondary chamber has reached a tem- time it is charged with a non-porous perature of 1,200 ±100 °C (2,192 ° ±180 °F). surface item. (6) Continuous emissions monitors (c)(1) Scrap metal recovery ovens and and recorders for carbon dioxide, car- smelters must either have a final per- bon monoxide, and excess oxygen in mit under RCRA (part 266, subpart H of the secondary chamber and continuous this chapter and § 270.66 of this chapter) temperature recorders in the primary or be operating under a valid State air and secondary chambers shall be in- emissions permit which includes a stalled and operated while the primary standard for PCBs. and secondary chambers are in oper- (2) Scrap metal recovery ovens and ation to assure that the two chambers smelters disposing of PCBs must pro- are within the operating parameters in paragraphs (a)(3) through (a)(5) of this vide notification as disposers of PCBs, section. are not required to submit annual re- (7) Emissions from the secondary ports, and shall otherwise comply with chamber must be vented through an ex- all applicable provisions of subparts J haust gas stack in accordance with ei- and K of this part, as well as other ap- ther: plicable Federal, State, and local laws (i) State or local air regulations or and regulations. permits, or (3) In lieu of the requirements in (ii) The standards in paragraph (a)(8) paragraph (c)(1) of this section, upon of this section. written request by the owner or oper- (8) Exhaust gas stack emissions shall ator of a scrap metal recovery oven or be for: particulates <0.015 grains/dry smelter, the EPA Regional Adminis- standard cubic foot, sulfur dioxide <35 trator, for the Region where the oven parts per million by volume (ppmv), ni- or smelter is located, may make a find- trogen oxide <150 ppmv, carbon mon- ing in writing, based on a site-specific oxide <35 ppmv, and hydrogen chloride risk assessment, that the oven or <35 ppmv. smelter does not pose an unreasonable

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risk of injury to health or the environ- (2) Synthetic membrane liners. Syn- ment because it is operating in compli- thetic membrane liners shall be used ance with the parameters and condi- when, in the judgment of the Regional tions listed in paragraph (a) or (b) of Administrator, the hydrologic or geo- this section even though the oven or logic conditions at the landfill require smelter does not have a RCRA or State such a liner in order to provide at least air permit as required by paragraph a permeability equivalent to the soils (c)(1) of this section. The written rein paragraph (b)(1) of this section. quest shall include a site-specific risk Whenever a synthetic liner is used at a assessment. landfill site, special precautions shall (d) PCB liquids, other liquid waste be taken to insure that its integrity is qualifying as waste oils which may be maintained and that it is chemically used as provided for at § 761.20(e), or compatible with PCBs. Adequate soil PCB remediation waste, other than underlining and soil cover shall be pro- PCB-Contaminated articles, may not vided to prevent excessive stress on the be disposed of in a scrap metal recov- liner and to prevent rupture of the ery oven or smelter unless approved or liner. The liner must have a minimum otherwise allowed under subpart D of thickness of 30 mils. this part. (3) Hydrologic conditions. The bottom [63 FR 35455, June 29, 1998, as amended at 64 of the landfill shall be above the histor- FR 33761, June 24, 1999] ical high groundwater table as provided below. Floodplains, shorelands, and § 761.75 Chemical waste landfills. groundwater recharge areas shall be This section applies to facilities used avoided. There shall be no hydraulic to dispose of PCBs in accordance with connection between the site and stand- the part. ing or flowing surface water. The site (a) General. A chemical waste landfill shall have monitoring wells and leach- used for the disposal of PCBs and PCB ate collection. The bottom of the land- Items shall be approved by the Agency fill liner system or natural in-place Regional Administrator pursuant to soil barrier shall be at least fifty feet paragraph (c) of this section. The land- from the historical high water table. fill shall meet all of the requirements (4) Flood protection. (i) If the landfill specified in paragraph (b) of this sec- site is below the 100-year floodwater tion, unless a waiver from these re- elevation, the operator shall provide quirements is obtained pursuant to surface water diversion dikes around paragraph (c)(4) of this section. In addi- the perimeter of the landfill site with a tion, the landfill shall meet any other minimum height equal to two feet requirements that may be prescribed above the 100-year floodwater ele- pursuant to paragraph (c)(3) of this sec- vation. tion. (ii) If the landfill site is above the (b) Technical requirements. Require- 100-year floodwater elevation, the oper- ments for chemical waste landfills used ators shall provide diversion structures for the disposal of PCBs and PCB Items capable of diverting all of the surface are as follows: water runoff from a 24-hour, 25-year (1) Soils. The landfill site shall be lo- storm. cated in thick, relatively impermeable (5) Topography. The landfill site shall formations such as large-area clay be located in an area of low to mod- pans. Where this is not possible, the erate relief to minimize erosion and to soil shall have a high clay and silt con- help prevent landslides or slumping. tent with the following parameters: (6) Monitoring systems—(i) Water sam- (i) In-place soil thickness, 4 feet or pling. (A) For all sites receiving PCBs, compacted soil liner thickness, 3 feet; the ground and surface water from the (ii) Permeability (cm/sec), equal to or disposal site area shall be sampled less than 1×10¥7; prior to commencing operations under (iii) Percent soil passing No. 200 an approval provided in paragraph (c) Sieve, >30; of this section for use as baseline data. (iv) Liquid Limit, >30; and (B) Any surface watercourse des- (v) Plasticity Index >15. ignated by the Regional Administrator

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using the authority provided in para- (7) Leachate collection. A leachate col- graph (c)(3)(ii) of this section shall be lection monitoring system shall be in- sampled at least monthly when the stalled above the chemical waste land- landfill is being used for disposal oper- fill. Leachate collection systems shall ations. be monitored monthly for quantity and (C) Any surface watercourse des- physicochemical characteristics of ignated by the Regional Administrator leachate produced. The leachate should using the authority provided in para- be either treated to acceptable limits graph (c)(3)(ii) of this section shall be for discharge in accordance with a sampled for a time period specified by State or Federal permit or disposed of the Regional Administrator on a fre- by another State or Federally approved quency of no less than once every six method. Water analysis shall be con- months after final closure of the dis- ducted as provided in paragraph posal area. (b)(6)(iii) of this section. Acceptable (ii) Groundwater monitor wells. (A) If leachate monitoring/collection systems underlying earth materials are homog- shall be any of the following designs, enous, impermeable, and uniformly unless a waiver is obtained pursuant to sloping in one direction, only three paragraph (c)(4) of this section. sampling points shall be necessary. (i) Simple leachate collection. This sys- These three points shall be equally tem consists of a gravity flow spaced on a line through the center of drainfield installed above the waste the disposal area and extending from disposal unit liner. This design is rec- the area of highest water table ele- ommended for use when semi-solid or vation to the area of the lowest water leachable solid wastes are placed in a table elevation on the property. lined pit excavated into a relatively (B) All monitor wells shall be cased thick, unsaturated, homogenous layer and the annular space between the of low permeability soil. monitor zone (zone of saturation) and (ii) Compound leachate collection. This the surface shall be completely system consists of a gravity flow backfilled with Portland cement or an drainfield installed above the waste equivalent material and plugged with disposal unit liner and above a sec- Portland cement to effectively prevent ondary installed liner. This design is percolation of surface water into the recommended for use when semi-liquid well bore. The well opening at the sur- or leachable solid wastes are placed in face shall have a removable cap to pro- a lined pit excavated into relatively vide access and to prevent entrance of permeable soil. rainfall or stormwater runoff. The well (iii) Suction lysimeters. This system shall be pumped to remove the volume consists of a network of porous ceramic of liquid initially contained in the well cups connected by hoses/tubing to a before obtaining a sample for analysis. vacuum pump. The porous ceramic The discharge shall be treated to meet cups or suction lysimeters are installed applicable State or Federal discharge along the sides and under the bottom standards or recycled to the chemical of the waste disposal unit liner. This waste landfill. type of system works best when in- (iii) Water analysis. As a minimum, stalled in a relatively permeable un- all samples shall be analyzed for the saturated soil immediately adjacent to following parameters, and all data and the bottom and/or sides of the disposal records of the sampling and analysis facility. shall be maintained as required in (8) Chemical waste landfill operations. § 761.180(d)(1). Sampling methods and (i) PCBs and PCB Items shall be placed analytical procedures for these param- in a landfill in a manner that will pre- eters shall comply with those specified vent damage to containers or articles. in 40 CFR part 136 as amended in 41 FR Other wastes placed in the landfill that 52779 on December 1, 1976. are not chemically compatible with (A) PCBs. PCBs and PCB Items including organic (B) pH. solvents shall be segregated from the (C) Specific conductance. PCBs throughout the waste handling (D) Chlorinated organics. and disposal process.

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(ii) An operation plan shall be devel- (iv) Records shall be maintained for oped and submitted to the Regional all PCB disposal operations and shall Administrator for approval as required include information on the PCB con- in paragraph (c) of this section. This centration in liquid wastes and the plan shall include detailed expla- three dimensional burial coordinates nations of the procedures to be used for for PCBs and PCB Items. Additional recordkeeping, surface water handling records shall be developed and main- procedures, excavation and backfilling, tained as required in § 761.180. waste segregation burial coordinates, (9) Supporting facilities. (i) A six foot vehicle and equipment movement, use woven mesh fence, wall, or similar de- of roadways, leachate collection sys- vice shall be placed around the site to tems, sampling and monitoring proce- prevent unauthorized persons and ani- dures, monitoring wells, environmental mals from entering. emergency contingency plans, and se- (ii) Roads shall be maintained to and curity measures to protect against within the site which are adequate to vandalism and unauthorized waste support the operation and maintenance placements. EPA guidelines entitled of the site without causing safety or ‘‘Thermal Processing and Land Dis- nuisance problems or hazardous condi- posal of Solid Waste’’ (39 FR 29337, Aug. tions. 14, 1974) are a useful reference in prepa- (iii) The site shall be operated and ration of this plan. If the facility is to maintained in a manner to prevent safety problems or hazardous condi- be used to dispose of liquid wastes con- tions resulting from spilled liquids and taining between 50 ppm and 500 ppm windblown materials. PCB, the operations plan must include (c) Approval of chemical waste landfills. procedures to determine that liquid Prior to the disposal of any PCBs and PCBs to be disposed of at the landfill PCB Items in a chemical waste landfill, do not exceed 500 ppm PCB and meas- the owner or operator of the landfill ures to prevent the migration of PCBs shall receive written approval of the from the landfill. Bulk liquids not ex- Agency Regional Administrator for the ceeding 500 ppm PCBs may be disposed Region in which the landfill is located. of provided such waste is pretreated The approval shall be obtained in the and/or stabilized (e.g., chemically following manner: fixed, evaporated, mixed with dry inert (1) Initial report. The owner or oper- absorbant) to reduce its liquid content ator shall submit to the Regional Ad- or increase its solid content so that a ministrator an initial report which non-flowing consistency is achieved to contains: eliminate the presence of free liquids (i) The location of the landfill; prior to final disposal in a landfill. PCB (ii) A detailed description of the Container of liquid PCBs with a con- landfill including general site plans centration between 50 and 500 ppm PCB and design drawings; may be disposed of if each container is (iii) An engineering report describing surrounded by an amount of inert the manner is which the landfill com- sorbant material capable of absorbing plies with the requirements for chem- all of the liquid contents of the conical waste landfills specified in para- tainer. graph (b) of this section; (iii) Ignitable wastes shall not be dis- (iv) Sampling and monitoring equip- posed of in chemical waste landfills. ment and facilities available; Liquid ignitable wastes are wastes that (v) Expected waste volumes of PCBs; have a flash point less than 60 degrees (vi) General description of waste ma- C (140 degrees F) as determined by the terials other than PCBs that are ex- following method or an equivalent pected to be disposed of in the landfill; method: Flash point of liquids shall be (vii) Landfill operations plan as re- determined by a Pensky-Martens quired in paragraph (b) of this section; Closed Cup Tester, using the protocol (viii) Any local, State, or Federal specified in ASTM D 93–90, or the permits or approvals; and Setaflash Closed Tester using the pro- (ix) Any schedules or plans for com- tocol specified in ASTM Standard D– plying with the approval requirements 3278–89. of these regulations.

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(2) Other information. In addition to be stated in writing and included as the information contained in the re- part of the approval. port described in paragraph (c)(1) of (5) Persons approved. Any approval this section, the Regional Adminis- will designate the persons who own and trator may require the owner or oper- who are authorized to operate the ator to submit any other information chemical waste landfill, and will apply that the Regional Administrator finds only to such persons, except as pro- to be reasonably necessary to deter- vided by paragraph (c)(7) of this sec- mine whether a chemical waste landfill tion. should be approved. Such other infor- (6) Final approval. Approval of a mation shall be restricted to the types chemical waste landfill will be in writ- of information required in paragraphs ing and will be signed by the Regional (c)(1) (i) through (ix) of this section. Administrator. The approval will state (3) Contents of approval. (i) Except as all requirements applicable to the ap- provided in paragraph (c)(4) of this sec- proved landfill. tion the Regional Administrator may (7) Transfer of property. Any person not approve a chemical waste landfill who owns or operates an approved for the disposal of PCBs and PCB chemical waste landfill must notify Items, unless he finds that the landfill EPA at least 30 days before transfer- meets all of the requirements of para- ring ownership in the property or graph (b) of this section. transferring the right to conduct the (ii) In addition to the requirements of chemical waste landfill operation. The paragraph (b) of this section, the Re- transferor must also submit to EPA, at gional Administrator may include in least 30 days before such transfer, a no- an approval any other requirements or tarized affidavit signed by the trans- provisions that the Regional Adminis- feree which states that the transferee trator finds are necessary to ensure will abide by the transferor’s EPA that operation of the chemical waste chemical waste landfill approval. With- landfill does not present an unreason- in 30 days of receiving such notifica- able risk of injury to health or the en- tion and affidavit, EPA will issue an vironment from PCBs. Such provisions amended approval substituting the may include a fixed period of time for transferee’s name for the transferor’s which the approval is valid. name, or EPA may require the trans- The approval may also include a stipu- feree to apply for a new chemical waste lation that the operator of the chem- landfill approval. In the latter case, the ical waste landfill report to the Re- transferee must abide by the trans- gional Administrator any instance feror’s EPA approval until EPA issues when PCBs are detectable during moni- the new approval to the transferee. toring activities conducted pursuant to (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C. paragraph (b)(6) of this section. 2605) (4) Waivers. An owner or operator of a [44 FR 31542, May 31, 1979. Redesignated at 47 chemical waste landfill may submit FR 19527, May 6, 1982, and amended at 48 FR evidence to the Regional Adminis- 5730, Feb. 8, 1983; 49 FR 28191, July 10, 1984; 53 trator that operation of the landfill FR 12524, Apr. 15, 1988; 53 FR 21641, June 9, will not present an unreasonable risk 1988; 57 FR 13323, Apr. 16, 1992; 63 FR 35456, of injury to health or the environment June 29, 1998] from PCBs when one or more of the requirements of paragraph (b) of this sec- § 761.77 Coordinated approval. tion are not met. On the basis of such (a) General requirements. Notwith- evidence and any other available infor- standing any other provision of this mation, the Regional Administrator part, the EPA Regional Administrator may in his discretion find that one or for the Region in which a PCB disposal more of the requirements of paragraph or PCB commercial storage facility de- (b) of this section is not necessary to scribed in paragraphs (b) and (c) of this protect against such a risk and may section is located may issue a TSCA waive the requirements in any ap- PCB Coordinated Approval to the per- proval for that landfill. Any finding sons described in those paragraphs if and waiver under this paragraph will the conditions listed in this section are

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met. A TSCA PCB Coordinated Ap- will not present an unreasonable risk proval will designate the persons who of injury to health or the environment. own and who are authorized to operate The EPA Regional Administrator shall the facilities described in paragraphs either: (b) and (c) of this section and will apply (A) Issue a written notice of defi- only to such persons. All requirements, ciency explaining why the request for conditions, and limitations of any approval is deficient. If appropriate, other permit or waste management the EPA Regional Administrator may document cited or described in para- either: graphs (b) and (c) of this section, as the (1) Request additional information to technical or legal basis on which the cure the deficiency. TSCA PCB Coordinated Approval is (2) Deny the request for a TSCA PCB issued, are conditions of the TSCA PCB Coordinated Approval. Coordinated Approval. (B) Issue a letter granting or denying (1) Persons seeking a TSCA PCB Co- the TSCA PCB Coordinated Approval. ordinated Approval shall submit a re- If the EPA Regional Administrator quest for approval by certified mail, to grants the TSCA PCB Coordinated Ap- the EPA Regional Administrator for proval, he or she may acknowledge the the Region in which the activity will non-TSCA approval meets the regu- take place. Persons seeking a TSCA latory requirements under TSCA as PCB Coordinated Approval for a new written, or require additional condi- PCB activity shall submit the request tions the EPA Regional Administrator for approval at the same time they has determined are necessary to pre- seek a permit, approval, or other ac- vent unreasonable risk of injury to tion for a PCB waste management ac- health or the environment. tivity under any other Federal or State authority. (C) If the EPA Regional Adminis- (i) The request for a TSCA PCB Co- trator denies a request for a Coordi- ordinated Approval shall include a nated Approval under paragraphs copy of the letter from EPA announc- (a)(1)(ii)(A) or (a)(1)(ii)(B) of this sec- ing or confirming the EPA identification, the person who requested the tion number issued to the facility for TSCA PCB Coordinated Approval may conducting PCB activities; the name, submit an application for a TSCA Dis- organization, and telephone number of posal Approval. the person who is the contact point for (2) The EPA Regional Administrator the non-TSCA Federal or State waste may issue a notice of deficiency, re- management authority; a copy of the voke the TSCA PCB Coordinated Ap- relevant permit or waste management proval, require the person to whom the document specified in paragraphs (b) TSCA PCB Coordinated Approval was and (c) of this section, including all re- issued to submit an application for a quirements, conditions, and limita- TSCA PCB approval, or bring an en- tions, if the EPA Regional Adminis- forcement action under TSCA if he or trator does not have a copy of the doc- she determines that: ument, or a description of the waste (i) Conditions of the approval relat- management activities to be conducted ing to PCB waste management activi- if a permit or other relevant waste ties are not met. management document has not been (ii) The PCB waste management issued; and a certification that the per- process is being operated in a manner son who owns or operates the facility is which may result in an unreasonable aware of and will adhere to the TSCA risk of injury to health or the environ- PCB reporting and recordkeeping re- ment. quirements at subparts J and K of this (iii) The non-TSCA approval expires, part. is revoked, is suspended, or otherwise (ii) The EPA Regional Administrator ceases to be in full effect. shall review the request for complete- (3) Any person with a TSCA PCB Co- ness, for compliance with the require- ordinated Approval must notify the ments of paragraphs (b) and (c) of this EPA Regional Administrator in writ- section, and to ensure that the PCB ac- ing within 5 calendar days of changes tivity for which approval is requested relating to PCB waste requirements in

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the non-TSCA waste management doc- storage requirements at §§ 761.65(a), (c), ument which serves as the basis for a and (d)(2), as appropriate. TSCA PCB Coordinated Approval. (4) Complies with the reporting and Changes in the ownership of a commer- recordkeeping requirements in sub- cial storage facility which holds a parts J and K of this part. TSCA PCB Coordinated Approval shall (c) A person conducting research and be handled pursuant to § 761.65(j). development (R&D) into PCB disposal (b) Any person who owns or operates methods (regardless of PCB concentra- a facility that he or she intends to use tion), or conducting PCB remediation to landfill PCB wastes; incinerate PCB activities may apply for a TSCA PCB wastes; dispose of PCB wastes using an Coordinated Approval. The EPA Re- alternative disposal method that is gional Administrator may approve the equivalent to disposal in an incinerator request if the EPA Regional Adminis- approved under § 761.70 or a high effi- trator determines that the activity ciency boiler operating in compliance will not pose an unreasonable risk of with § 761.71; or stores PCB wastes may injury to health or the environment apply for a TSCA PCB Coordinated Ap- and the person: proval. The EPA Regional Adminis- (1)(i) Has a permit or other decision trator may approve the request if the and enforcement document issued or EPA Regional Administrator deter- otherwise agreed to by EPA, or permit mines that the activity will not pose or other decision and enforcement doc- an unreasonable risk of injury to ument issued by an authorized State health or the environment and the per- Director for a State program that has son: been approved by EPA, which exercises (1)(i) Has a waste management per- control over the management of PCB mit or other decision or enforcement wastes, and that person is in compli- document which exercises control over ance with all terms and conditions of PCB wastes, issued by EPA or an au- that document; or thorized State Director for a State pro- (ii) Has a permit, which exercises gram that has been approved by EPA control over the management of PCB and is no less stringent in protection of wastes, issued by a State Director pur- health or the environment than the ap- suant to a State PCB disposal program plicable TSCA requirements found in no less stringent than the require- this part; or ments in this part. (ii) Has a PCB waste management (2) Complies with the terms and con- permit or other decision or enforce- ditions of that permit or other decision ment document issued by a State Di- and enforcement document. rector pursuant to a State PCB waste (3) Complies with the reporting and management program no less stringent recordkeeping requirements in sub- in protection of health or the environ- parts J and K of this part. ment than the applicable TSCA re- [63 FR 35456, June 29, 1998] quirements found in this part; or (iii) Is subject to a waste manage- § 761.79 Decontamination standards ment permit or other decision or en- and procedures. forcement document which is applica- (a) Applicability. This section estab- ble to the disposal of PCBs and which lishes decontamination standards and was issued through the promulgation procedures for removing PCBs, which of a regulation published in Title 40 of are regulated for disposal, from water, the Code of Federal Regulations. organic liquids, non-porous surfaces (2) Complies with the terms and con- (including scrap metal from disassem- ditions of the permit or other decision bled electrical equipment), concrete, or enforcement document described in and non-porous surfaces covered with a paragraph (b)(1) of this section. porous surface, such as paint or coat- (3) Unless otherwise waived or modi- ing on metal. fied in writing by the EPA Regional (1) Decontamination in accordance Administrator, complies with with this section does not require a dis- § 761.75(b); § 761.70(a)(1) through (a)(9), posal approval under subpart D of this (b)(1) and (b)(2), and (c); or the PCB part.

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(2) Materials from which PCBs have ganic liquids containing PCBs is <2 been removed by decontamination in milligrams per kilogram (i.e., <2 ppm accordance with this section may be PCBs). distributed in commerce in accordance (3) The decontamination standard for with § 761.20(c)(5). non-porous surfaces in contact with (3) Materials from which PCBs have liquid and non-liquid PCBs is: been removed by decontamination in (i) For unrestricted use: accordance with this section may be (A) For non-porous surfaces pre- used or reused in accordance with viously in contact with liquid PCBs at § 761.30(u). any concentration, where no free-flow- (4) Materials from which PCBs have ing liquids are currently present, ≤10 been removed by decontamination in micrograms PCBs per 100 square centi- accordance with this section, not in- meters (≤10 μg/100 cm2) as measured by cluding decontamination waste and re- a standard wipe test (§ 761.123) at loca- siduals under paragraph (g) of this sections selected in accordance with sub- tion, are unregulated for disposal under part P of this part. subpart D of this part. (B) For non-porous surfaces in con- (5) Any person decontaminating po- tact with non-liquid PCBs (including rous surfaces other than concrete non-porous surfaces covered with a po- under paragraph (b)(4) of this section rous surface, such as paint or coating and non-porous surfaces covered with a on metal), cleaning to Visual Standard porous surface, such as paint or coat- No. 2, Near-White Blast Cleaned Sur- ing on metal, under paragraph (b)(3) or face Finish, of the National Associa- (c)(6) of this section must obtain an al- tion of Corrosion Engineers (NACE). A ternative decontamination approval in person shall verify compliance with accordance with paragraph (h) of this standard No. 2 by visually inspecting section. all cleaned areas. (6) Any person engaging in decon- (ii) For disposal in a smelter oper- tamination under this section is re- ating in accordance with § 761.72(b): sponsible for determining and com- (A) For non-porous surfaces pre- plying with all other applicable Fed- viously in contact with liquid PCBs at eral, State, and local laws and regula- any concentration, where no free-flow- tions. ing liquids are currently present, <100 (b) Decontamination standards. Chop- μg/100 cm2 as measured by a standard ping (including wire chopping), dis- wipe test (§ 761.123) at locations se- tilling, filtering, oil/water separation, lected in accordance with subpart P of spraying, soaking, wiping, stripping of this part. insulation, scraping, scarification or (B) For non-porous surfaces in con- the use of abrasives or solvents may be tact with non-liquid PCBs (including used to remove or separate PCBs, to non-porous surfaces covered with a po- the following standards, from liquids, rous surface, such as paint or coating concrete, or non-porous surfaces. on metal), cleaning to Visual Standard (1) The decontamination standard for No. 3, Commercial Blast Cleaned Sur- water containing PCBs is: face Finish, of the National Associa- (i) Less than 200 μg/L (i.e., <200 ppb tion of Corrosion Engineers (NACE). A PCBs) for non-contact use in a closed person shall verify compliance with system where there are no releases; standard No. 3 by visually inspecting (ii) For water discharged to a treat- all cleaned areas. ment works (as defined in § 503.9(aa) of (4) The decontamination standard for this chapter) or to navigable waters, <3 concrete is ≤10 μg/100 cm2 as measured μg/L (approximately <3 ppb) or a PCB by a standard wipe test (§ 761.123) if the discharge limit included in a permit decontamination procedure is com- issued under section 307(b) or 402 of the menced within 72 hours of the initial Clean Water Act; or spill of PCBs to the concrete or portion (iii) Less than or equal to 0.5 μg/L thereof being decontaminated. (i.e., approximately ≤0.5 ppb PCBs) for (c) Self-implementing decontamination unrestricted use. procedures. The following self-imple- (2) The decontamination standard for menting decontamination procedures organic liquids and non-aqueous inor- are available as an alternative to the

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measurement-based decontamination (up to 70 percent PCB in a mixture of methods specified in paragraph (b) of trichlorobenzenes and this section. Any person performing tetrachlorobenzenes) must do so as fol- self-implementing decontamination lows: must comply with one of the following (i) Drain the free-flowing MODEF or procedures. askarel and allow the residual surfaces (1) Any person decontaminating a to drain for an additional 15 hours. PCB Container must do so by flushing (ii) Dispose of drained MODEF or the internal surfaces of the container askarel according to paragraph (g) of three times with a solvent containing this section. <50 ppm PCBs. Each rinse shall use a (iii) Soak the surfaces to be decon- volume of the flushing solvent equal to taminated in a sufficient amount of approximately 10 percent of the PCB clean PODF (containing <2 ppm PCBs) Container capacity. such that there is a minimum of 800 ml (2) Any person decontaminating mov- of PODF for each 100 cm2 of contami- able equipment contaminated by PCBs, nated or potentially contaminated sur- tools, and sampling equipment may do face for at least 15 hours at ≥20 °C. so by: (iv) Approved PODFs include: (i) Swabbing surfaces that have con- (A) Kerosene. tacted PCBs with a solvent; (B) Diesel fuel. (ii) A double wash/rinse as defined in (C) Terpene hydrocarbons. subpart S of this part; or (D) Mixtures of terpene hydrocarbons (iii) Another applicable decontamina- and terpene alcohols. tion procedure in this section. (v) Drain the PODF from the sur- (3) Any person decontaminating a faces. non-porous surface in contact with (vi) Dispose of the drained PODF in free-flowing mineral oil dielectric fluid accordance with paragraph (g) of this (MODEF) at levels ≤10,000 ppm PCBs section. must do so as follows: (vii) Resoak the surfaces to be decon- (i) Drain the free-flowing MODEF and taminated, pursuant to paragraph allow the residual surfaces to drain for (c)(3)(iii) of this section, in a sufficient an additional 15 hours. amount of clean PODF (containing <2 (ii) Dispose of drained MODEF ac- ppm PCBs) such that there is a min- cording to paragraph (g) of this sec- imum of 800 ml of PODF for each 100 tion. cm2 of surface for at least 15 hours at (iii) Soak the surfaces to be decon- ≥20 °C. taminated in a sufficient amount of (viii) Drain the PODF from the sur- clean (containing <2 ppm PCBs) per- faces. formance-based organic decontamina- (ix) Dispose of the drained PODF in tion fluid (PODF) such that there is a accordance with paragraph (g) of this minimum of 800 ml of PODF for each section. 100 cm2 of contaminated or potentially (5) Any person decontaminating pip- contaminated surface for at least 15 ing and air lines in an air compressor hours at ≥20 °C. system must do so as follows: (iv) Approved PODFs include: (i) Before decontamination proceeds, (A) Kerosene. disconnect or bypass the air compres- (B) Diesel fuel. sors and air dryers from the piping and (C) Terpene hydrocarbons. air lines and decontaminate the air (D) Mixtures of terpene hydrocarbons compressors and air dryers separately and terpene alcohols. in accordance with paragraphs (b), (v) Drain the PODF from the sur- (c)(1) through (c)(4), or (c)(6) of this faces. section. Dispose of filter media and (vi) Dispose of the drained PODF in desiccant in the air dyers based on accordance with paragraph (g) of this their existing PCB concentration. section. (ii) Test the connecting line and ap- (4) Any person decontaminating a purtenances of the system to assure non-porous surface in contact with that there is no leakage. Test by intro- free-flowing MODEF containing >10,000 ducing air into the closed system at ppm PCB in MODEF or askarel PCB from 90 to 100 pounds per square inch

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(psi). Only if there is a pressure drop of nated with MODEF or other PCB liq- <5 psi in 30 minutes may decontamina- uids, in accordance with the self-imple- tion take place. menting procedures found in subpart T (iii) When there is no leakage, fill the of this part. Specific conditions for the piping and air lines with clean (con- performance-based testing from this taining <2 ppm PCBs) solvent. Solvents validation are determined in the vali- include PODF, aqueous potassium hy- dation study. droxide at a pH between 9 and 12, or (e) Limitation of exposure and control water containing 5 percent sodium hy- of releases. (1) Any person conducting droxide by weight. decontamination activities under this (iv) Circulate the solvent to achieve section shall take necessary measures turbulent flow through the piping and to protect against direct release of air lines in the air compressor system PCBs to the environment from the de- until the total volume of solvent cir- contamination area. culated equals 10 times the total vol- (2) Persons participating in decon- ume of the particular article being de- tamination activities shall wear or use contaminated, then drain the solvent. protective clothing or equipment to Calculate the total volume of solvent protect against dermal contact or inha- circulated by multiplying the pump lation of PCBs or materials containing rate by the time of pumping. Turbulent PCBs. flow means a Reynolds number range (f) Sampling and recordkeeping. (1) from 20,000 to 43,000. Refill the system Confirmatory sampling is required with clean solvent and repeat the cir- under paragraph (b) of this section. For culation and drain process. liquids described in paragraphs (b)(1) (6) Any person using thermal proc- and (b)(2) of this section, sample in ac- esses to decontaminate metal surfaces cordance with §§ 761.269 and 761.272. For in contact with PCBs, as required by non-porous surfaces and concrete de- § 761.62(a)(6), must use one of the fol- scribed in paragraphs (b)(3) and (b)(4) of lowing options: this section, sample in accordance with (i) Surfaces in contact with liquid subpart P of this part. A written record and non-liquid PCBs at concentrations of such sampling must be established <500 ppm may be decontaminated in a and maintained for 3 years from the scrap metal recovery oven or smelter date of any decontamination under this for purposes of disposal in accordance section. The record must show sam- with § 761.72. pling locations and analytical results (ii) Surfaces in contact with liquid or and must be retained at the site of the non-liquid PCBs at concentrations ≥500 decontamination or a copy of the ppm may be smelted in a smelter oper- record must be made available to EPA ating in accordance with § 761.72(b), but in a timely manner, if requested. In ad- must first be decontaminated in ac- dition, recordkeeping is required in accordance with § 761.72(a) or to a surface cordance with § 761.180(a) for all wastes concentration of <100 μg/100 cm2. generated by a decontamination proc- (d) Decontamination solvents. (1) Un- ess and regulated for disposal under less otherwise provided in paragraphs this subpart. (c)(3) through (c)(5) of this section, the (2) Confirmatory sampling is not re- solubility of PCBs in any solvent used quired for self-implementing decon- for purposes of decontamination under tamination procedures under para- this section must be 5 percent or more graph (c) of this section. Any person by weight. using these procedures must retain a (2) The solvent may be reused for de- written record documenting compli- contamination so long as its PCB con- ance with the procedures for 3 years centration is <50 ppm. after completion of the decontamina- (3) Solvent shall be disposed of under tion procedures (e.g., video recordings, paragraph (g) of this section. photographs). (4) Other than as allowed in para- (g) Decontamination waste and resi- graphs (c)(3) and (c)(4) of this section, dues. Decontamination waste and resi- solvents may be tested and validated dues shall be disposed of at their exist- for performance-based decontamina- ing PCB concentration unless other- tion of non-porous surfaces contami- wise specified.

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(1) Distillation bottoms or residues capable of decontaminating the mate- and filter media are regulated for dis- rial to the applicable level set out in posal as PCB remediation waste. paragraphs (b)(1) through (b)(4) of this (2) PCBs physically separated from section. regulated waste during decontamina- (2) Any person wishing to decontami- tion (such as by chopping, shredding, nate material described in paragraph scraping, abrading or oil/water separa- (a) of this section using a self-imple- tion, as opposed to solvent rinsing and menting procedure other than pre- soaking), other than wastes described scribed in paragraph (c) of this section in paragraph (g)(1) of this section, are must apply in writing to the Regional regulated for disposal at their original Administrator in the Region where the concentration. activity would take place, for decon- (3) Hydrocarbon solvent used or re- tamination activity occurring in a sin- used for decontamination under this gle EPA Region; or to the Director, Of- section that contains <50 ppm PCB fice of Resource Conservation and Re- must be burned and marketed in accordance with the requirements for covery, for decontamination activity used oil in § 761.20(e), disposed of in ac- occurring in more than one EPA Re- cordance with § 761.60(a) or (e), or de- gion. Each application must describe contaminated pursuant to this section. the material to be decontaminated and (4) Chlorinated solvent at any PCB the proposed self-implementing decon- concentration used for decontamina- tamination method and must include a tion under this section shall be dis- proposed validation study to confirm posed of in an incinerator operating in performance of the method. compliance with § 761.70, or decontami- (3) Any person wishing to sample de- nated pursuant to this section. contaminated material in a manner (5) Solvents ≥50 ppm other than those other than prescribed in paragraph (f) described in paragraphs (g)(3) and (g)(4) of this section must apply in writing to of this section shall be disposed of in the Regional Administrator in the Re- accordance with § 761.60(a) or decon- gion where the activity would take taminated pursuant to this section. place, for decontamination activity oc- (6) Non-liquid cleaning materials and curring in a single EPA Region; or to personal protective equipment waste at the Director, Office of Resource Con- any concentration, including non-po- servation and Recovery, for decon- rous surfaces and other non-liquid ma- tamination activity occurring in more terials such as rags, gloves, booties, than one EPA Region. Each application other disposable personal protective must contain a description of the ma- equipment, and similar materials re- terial to be decontaminated, the nature sulting from decontamination shall be and PCB concentration of the contami- disposed of in accordance with nating material (if known), the decon- § 761.61(a)(5)(v). tamination method, the proposed sam- (h) Alternative decontamination or sampling procedure, and a justification for pling approval. (1) Any person wishing how the proposed sampling is equiva- to decontaminate material described in lent to or more comprehensive than paragraph (a) of this section in a man- the sampling procedure required under ner other than prescribed in paragraph (b) of this section must apply in writ- paragraph (f) of this section. ing to the Regional Administrator in (4) EPA may request additional infor- the Region where the activity would mation that it believes necessary to take place, for decontamination activ- evaluate the application. ity occurring in a single EPA Region; (5) EPA will issue a written decision or to the Director, Office of Resource on each application for risk-based de- Conservation and Recovery, for decon- contamination or sampling. No person tamination activity occurring in more may conduct decontamination or sam- than one EPA Region. Each application pling under this paragraph prior to ob- must describe the material to be de- taining written approval from EPA. contaminated and the proposed decon- EPA will approve an application if it tamination method, and must dem- finds that the proposed decontamina- onstrate that the proposed method is tion or sampling method will not pose

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an unreasonable risk of injury to (iv) Unison annually notifies and de- health or the environment. scribes to EPA its attempts to have samples analyzed abroad. [63 FR 35457, June 29, 1998, as amended at 64 FR 33761, June 24, 1999; 72 FR 57240, Oct. 9, (2) [Reserved] 2007; 74 FR 30233, June 25, 2009] (e) The Administrator grants a class exemption to all research and develop- Subpart E—Exemptions ment (R&D) facilities for a period of 1 year to manufacture or import PCBs § 761.80 Manufacturing, processing for use solely in the manufacturer or and distribution in commerce ex- importer’s own research for the devel- emptions. opment of PCB disposal technologies. (a) The Administrator grants the fol- Each person that wishes to be part of lowing petitioner(s) an exemption for 1 the exemption must meet the following year to process and distribute in com- conditions: merce PCBs for use as a mounting me- (1) A petition for an exemption from dium in microscopy: the PCB prohibition on manufacturing (1) McCrone Accessories Components, PCBs must be received by EPA 60 days Division of Walter C. McCrone Associ- prior to engaging in these activities. ates, Inc., 2820 South Michigan Avenue, (2) Requests for renewal must be filed Chicago, IL. 60616. pursuant to § 750.11 of this chapter. (2) [Reserved] EPA will deem any properly filed re- (b) The Administrator grants the fol- quest for the renewal of the exemption lowing petitioner(s) an exemption for 1 by any member of the class as a re- year to process and distribute in com- newal request for the entire class. merce PCBs for use as a mounting me- (3) The quantity of the PCBs manu- dium in microscopy, an immersion oil factured annually must not exceed 500 in low fluorescence microscopy and an grams by total weight of pure PCBs. optical liquid: Any person who wishes to manufacture (1) R.P. Cargille Laboratories, Inc., 55 or import more than 500 grams of PCBs Commerce Road, Cedar Grove, N.J. in 1 year must receive written approval 07009. from the Director, National Program (2) [Reserved] Chemicals Division to exceed the limi- (c) The Administrator grants the fol- tations established by this provision. lowing petitioner(s) an exemption for 1 The Director, National Program year to export PCBs for use in small Chemicals Division may grant approval quantities for research and develop- without further rulemaking. Any in- ment: crease granted will be in writing and (1) Accu-Standard, New Haven, CT. will extend only for a maximum of the 06503. time remaining in a specific exemption (2) ManTech, Research Triangle year. Park, NC 27709. (4) The owner or operator of the facil- (d) The Administrator grants the fol- ity must notify the EPA Regional Ad- lowing petitioner(s) an exemption for 1 ministrator in writing 30 days prior to year to import (manufacture) into the the commencement of R&D activities United States, small quantities of ex- that include the manufacture or im- isting PCB fluids from electrical equip- port of PCBs under the exemption, un- ment for analysis: less the facility has obtained a PCB (1) Unison Transformer Services, R&D approval from EPA pursuant to Inc., Tarrytown, N.Y. 10591, provided § 761.60(e), § 761.60(i)(2), § 761.70(a), or each of the following conditions are § 761.70(b) and the approval contains a met: provision allowing the manufacture of (i) The samples must be shipped in 5.0 PCBs. ml or less, hermetically sealed vials. (5) Records are maintained of their (ii) The exemption is limited to no PCB activities for a period of 3 years more than 250 total samples per year. after ceasing operations. The records (iii) Unison makes quarterly inspec- must include the sources and the an- tions of its laboratories to ensure that nual amounts of PCBs received if improper safety procedures are being fol- ported and the type and annual amount lowed. of PCBs that were manufactured.

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(6) All PCBs and materials con- PCB waste material, provided the PCBs taining PCBs, regardless of concentra- are manufactured, imported, processed, tion, remaining from the disposal-re- distributed in commerce, or exported lated studies must be disposed of ac- solely for the purpose of R&D and the cording to § 761.60(j)(1)(vi), or decon- following conditions are met: taminated pursuant to § 761.79, based on (1) Notification in the form of a peti- the original PCB concentration. tion for an exemption from the PCB (f) The Administrator grants the fol- prohibitions on manufacture, import, lowing petitioner(s) an exemption for 1 processing, distribution in commerce, year to manufacture PCBs for use in or export is received by EPA 60 days small quantities for research and de- prior to engaging in these activities. velopment: (2) Requests for renewal are filed pur- (1) California Bionuclear Corp., Sun suant to §§ 750.11 and 750.31 of this chap- Valley, CA 91352 (ME–13). ter. EPA will deem any properly filed (2) Foxboro Co., North Haven, CT request for the renewal of the exemp- 06473 (ME–6). tion by any member of the class as a (3) ULTRA-Scientific, Inc.,Hope, RI renewal request for the entire class. 02831 (ME–99.1). (3) The PCBs are packaged in one or (4) Midwest Research Institute, Kan- more hermetically sealed containers of sas City, MO 64110 (ME–70.1). a volume of no more than 5.0 ml each. (5) Pathfinder Laboratories, St. Analytical reference samples derived Louis, MO 63146 (A division of Sigma from PCB waste material may be pack- Aldridge Corporation, St. Louis, MO, aged in a container larger than 5.0 ml 63178 (ME–76). when packaged pursuant to applicable (6) Radian Corp., Austin, TX 78766 DOT performance standards. (ME–81.2). (4) The quantity of PCBs manufac- (7) Wellington Sciences USA, College tured, imported, processed, distributed Station, TX 77840 (ME–104.1). in commerce, or exported annually (8) Accu-Standard, 25 Science Park, must not exceed 500 grams by total New Haven, CT. 06503. weight of pure PCBs. Any person who (g) The Administrator grants a class expects to manufacture, import, proc- exemption to all processors and dis- ess, distribute in commerce, or export tributors of PCBs in small quantities more than 500 grams of PCBs in 1 year for research and development provided or to exceed the 5.0 ml packaging re- that the following conditions are met: quirement must obtain a written ap- (1) All processors and distributors proval from the Director, National Pro- must maintain records of their PCB ac- gram Chemicals Division and must tivities for a period of 5 years. identify the sites of PCB activities and (2) Any person or company which ex- the quantity of PCBs to be manufac- pects to process or distribute in com- tured, imported, processed, distributed merce 100 grams (.22 lb) or more PCBs in commerce, or exported. Each request in 1 year must report to EPA identi- must include a justification. The Di- fying the sites of PCB activities and rector, National Program Chemicals the quantity of PCBs to be processed or Division, may grant approval without distributed in commerce. further rulemaking. Any increase (h) The Administrator grants the fol- granted will be in writing and will ex- lowing petitioners an exemption for 1 tend only for a maximum of the time year to process and distribute in com- remaining in a specific exemption year. merce PCBs for analytical reference (5) All treated and untreated PCB samples derived from actual waste ma- regulated material and material com- terials: ing into contact with regulated mate- (1) R.T. Corporation, Laramie, WY rial must be stored and disposed of ac- 82070. cording to subpart D of this part, or de- (2) [Reserved] contaminated pursuant to § 761.79. (i) The Administrator grants a class (6) All PCB materials must be dis- exemption to all persons who manufac- tributed in DOT-authorized packaging. ture, import, process, distribute in (7) Records are maintained of their commerce, or export PCBs, or analyt- PCB activities for a period of 3 years ical reference samples derived from after ceasing operations. The records

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must include the sources and the an- (o) The 1–year class exemption grant- nual amounts of PCBs received if im- ed to all processors and distributors of ported, the annual amount of PCBs PCBs in small quantities for research that were manufactured, the annual and development in paragraph (g) of amount of PCBs that were processed this section shall be renewed automati- and/or distributed in commerce (to in- cally unless information is submitted clude export), and the persons to whom affecting EPA’s conclusion that the the PCBs were shipped. class exemption, or the activities of (j) The Administrator grants the any individual or company included in United States Defense Logistics Agen- the exemption, will not pose an unrea- cy’s July 21, 2005 petition for an exemp- sonable risk of injury to health or the tion for 1 year to import 1,328,482 environment. EPA will evaluate the in- pounds of PCBs and PCB items stored formation, issue a proposed rule for or in use in Japan as identified in its petition, as amended, for disposal. public comment, and issue a final rule (k)–(l) [Reserved] affecting the class exemption or indi- (m) The Administrator grants the viduals or companies included in the following petitioner(s) an exemption class exemption. Until EPA issues a for 1 year to process and export small final rule, individuals and companies quantities of PCBs for research and de- included in the class exemption will be velopment: allowed to continue processing and dis- (1) Chem Service, Inc., West Chester, tributing PCBs in small quantities for PA 19380 (PDE–41). research and development. (2) Foxboro Co., North Haven, CT [55 FR 38999, Sept. 24, 1990, as amended at 59 06473 (ME–6). FR 16998, Apr. 11, 1994; 63 FR 35460, June 29, (3) PolyScience Corp., Niles, IL 60648 1998; 68 FR 4941, Jan. 31, 2003; 72 FR 53158, (PDE–178). Sept. 18, 2007] (4) ULTRA-Scientific, Inc., Hope, RI 02831 (PDE–282.1). (5) Supelco, Inc., Bellefonte, PA Subpart F—Transboundary 16823–0048 (PDE–41.2). Shipments of PCBs for Disposal (6) Radian Corp., Austin, TX 78766 (PDE–182.1). SOURCE: 61 FR 11107, Mar. 18, 1996, unless (7) Restek Corporation, Bellefonte, otherwise noted. PA (n) The 1–year exemption granted to § 761.91 Applicability. petitioners in paragraphs (a) through This subpart establishes require- (c)(1), (d), (f), and (m)(1) through (m)(6) ments under section 6 of TSCA applica- of this section shall be renewed auto- ble to the transboundary shipments of matically as long as there is no in- PCBs and PCB Items into and out of crease in the amount of PCBs to be the United States for disposal. Nothing processed and distributed, imported in this subpart is intended to obviate (manufactured), or exported, nor any or otherwise alter obligations applica- change in the manner of processing and distributing, importing (manufac- ble to imported or exported PCBs and turing), or exporting of PCBs. If there PCB Items under foreign laws, inter- is such a change, a new exemption peti- national agreements or arrangements, tion must be submitted to EPA and it other United States statutes and regu- will be addressed through an exemption lations, other sections of TSCA (e.g., rulemaking. In such a case, the activi- sections 13 and 14), or laws of the var- ties granted under the existing exemp- ious States of the United States. No tion may continue until the new peti- provision of this section shall be con- tion is addressed by rulemaking, but strued to affect or limit the applica- must conform to the terms of the exist- bility of any requirement applicable to ing exemption approved by EPA. The 1– transporters of PCB waste under regu- year exemption granted to petitioners lations issued by the U.S. Department in paragraphs (c)(2), (h) and (m)(7) of of Transportation (DOT) and set forth this section may be extended pursuant at 49 CFR parts 171-180. to 40 CFR 750.11(e) or 750.31(e).

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§ 761.93 Import for disposal. Subpart G—PCB Spill Cleanup (a) General provisions. No person may Policy import PCBs or PCB Items for disposal without an exemption issued under the SOURCE: 52 FR 10705, Apr. 2, 1987, unless authority of TSCA section 6(e)(3). otherwise noted. (b) [Reserved] § 761.120 Scope. [63 FR 35460, June 29, 1998] (a) General. This policy establishes § 761.97 Export for disposal. criteria EPA will use to determine the adequacy of the cleanup of spills re- (a) General provisions. No person sulting from the release of materials may export PCBs or PCB Items for dis- containing PCBs at concentrations of posal without an exemption, except 50 ppm or greater. The policy applies to that: spills which occur after May 4, 1987. (1) PCBs and PCB Items at con- (1) Existing spills (spills which oc- centrations <50 ppm (or <10 μg PCB/100 curred prior to May 4, 1987, are ex- cm2 if no free-flowing liquids are cluded from the scope of this policy for present) may be exported for disposal. two reasons: (2) For the purposes of this section, (i) For old spills which have already PCBs and PCB Items of unknown con- been discovered, this policy is not in- centrations shall be treated as if they tended to require additional cleanup contain ≥50 ppm. where a party has already cleaned a (b) [Reserved] spill in accordance with requirements [61 FR 11107, Mar. 18, 1996, as amended at 63 imposed by EPA through its regional FR 35460, June 29, 1998] offices, nor is this policy intended to interfere with ongoing litigation of en- § 761.99 Other transboundary ship- forcement actions which bring into ments. issue PCB spills cleanup. For purposes of this subpart, the fol- (ii) EPA recognizes that old spills lowing transboundary shipments are which are discovered after the effective not considered exports or imports: date of this policy will require site-by- site evaluation because of the likeli- (a) PCB waste generated in the hood that the site involves more perva- United States, transported outside the sive PCB contamination than fresh Customs Territory of the United States spills and because old spills are gen- (including any residuals resulting from erally more difficult to clean up than cleanup of spills of such wastes in tran- fresh spills (particularly on porous sur- sit) through another country or its ter- faces such as concrete). Therefore, ritorial waters, or through inter- spills which occurred before the effec- national waters, and returned to the tive date of this policy are to be decon- United States for disposal. taminated to requirements established (b) PCB waste in transit, including at the discretion of EPA, usually any residuals resulting from cleanup of through its regional offices. spills during transit, through the (2) EPA expects most PCB spills sub- United States (e.g., from Mexico to ject to the TSCA PCB regulations to Canada, from Canada to Mexico). conform to the typical spill situations (c) PCB waste transported from any considered in developing this policy. State to any other State for disposal, This policy does, however, exclude regardless of whether the waste enters from application of the final numerical or leaves the customs territory of the cleanup standards certain spill situa- United States, provided that the PCB tions from its scope: Spills directly waste or the PCBs from which the into surface waters, drinking water, waste was derived were present in the sewers, grazing lands, and vegetable United States on January 1, 1979, and gardens. These types of spills are sub- have remained within the United ject to final cleanup standards to be es- States since that date. tablished at the discretion of the re- [63 FR 35461, June 29, 1998, as amended at 66 gional office. These spills are, however, FR 17478, Mar. 30, 2001] subject to the immediate notification

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requirements and measures to mini- (1) For example, site-specific charac- mize further environmental contami- teristics, such as short depth to ground nation. water, type of soil, or the presence of a (3) For all other spills, EPA generally shallow well, may pose exceptionally expects the decontamination standards high potential for ground water con- of this policy to apply. Occasionally, tamination by PCBs remaining after some small percentage of spills covered cleanup to the standards specified in by this policy may warrant more strin- this policy. Spills that pose such a high gent cleanup requirements because of degree of potential for ground water additional routes of exposure or signifi- contamination have not been excluded cantly greater exposures than those as- from the policy under paragraph (d) of sumed in developing the final cleanup this section because the presence of standards of this policy. While the EPA such potential may not be readily ap- regional offices have the authority to parent. EPA feels that automatically require additional cleanup in these cir- excluding such spills from the scope of cumstances, the Regional Adminis- the policy could result in the delay of trator must first make a finding based cleanup—a particularly undesirable on the specific facts of a spill that ad- outcome if potential ground water conditional cleanup must occur to prevent tamination is, in fact, a significant unreasonable risk. In addition, before a concern. final decision is made to require addi- (2) In those situations, the Regional tional cleanup, the Regional Adminis- Administrator may require cleanup in trator must notify the Director, Office addition to that required under of Resource Conservation and Recovery § 761.125(b) and (c). However, the Re- of his/her finding and the basis for the gional Administrator must first make finding. a finding, based on the specific facts of (4) There may also be exceptional a spill, that additional cleanup is nec- spill situations that requires less strin- essary to prevent unreasonable risk. In gent cleanup or a different approach to addition, before making a final deci- cleanup because of factors associated sion on additional cleanup, the Re- with the particular spill. These factors gional Administrator must notify the may mitigate expected exposures and Director, Office of Resource Conserva- risks or make cleanup to these require- tion and Recovery of his finding and ments impracticable. the basis for the finding. (b) Spills that may require more strin- (c) Flexibility to allow less stringent or gent cleanup levels. For spills within the alternative requirements. EPA retains scope of this policy, EPA generally re- the flexibility to allow less stringent or tains, under § 761.135, the authority to alternative decontamination measures require additional cleanup upon finding based upon site-specific considerations. that, despite good faith efforts by the EPA will exercise this flexibility if the responsible party, the numerical de- responsible party demonstrates that contamination levels in the policy cleanup to the numerical decontamina- have not been met. In addition, EPA tion levels is clearly unwarranted be- foresees the possibility of exceptional cause of risk-mitigating factors, that spill situations in which site-specific compliance with the procedural re- risk factors may warrant additional quirements or numerical standards in cleanup to more stringent numerical the policy is impracticable at a par- decontamination levels than are re- ticular site, or that site-specific char- quired by the policy. In these situa- acteristics make the costs of cleanup tions, the Regional Administrator has prohibitive. The Regional Adminis- the authority to require cleanup to lev- trator will notify the Director, Office els lower than those included in this of Resource Conservation and Recovery policy upon finding that further clean- of any decision and the basis for the de- up must occur to prevent unreasonable cision to allow less stringent cleanup. risk. The Regional Administrator will The purpose of this notification is to consult with the Director, Office of Re- enable the Director, Office of Resource source Conservation and Recovery, Conservation and Recovery to ensure prior to making such a finding. consistency of spill cleanup standards

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under special circumstances across the ronmental Response Compensation and regions. Liability Act of 1980 (CERCLA) as (d) Excluded spills. (1) Although the amended by the Superfund Amend- spill situations in paragraphs (d)(2) (i) ments and Reauthorization Act through (vi) of this section are ex- (SARA). Where more than one require- cluded from the automatic application ment applies, the stricter standard of final decontamination standards must be met. under § 761.125 (b) and (c), the general (2) The Agency recognizes that the requirements under § 761.125(a) do apply existence of this policy will inevitably to these spills. In addition, all of these result in attempts to apply the stand- excluded situations require prac- ards to situations within the scope of ticable, immediate actions to contain other statutory authorities. However, the area of contamination. While these other statutes require the Agency to situations may not always require consider different or alternative fac- more stringent cleanup measures, the tors in determining appropriate correc- Agency is excluding these scenarios be- tive actions. In addition, the types and cause they will always involve signifi- magnitudes of exposures associated cant factors that may not be ade- with sites requiring corrective action quately addressed by cleanup standards under other statutes often involve im- based upon typical spill characteris- portant differences from those ex- tics. pected of the typical, electrical equip- (2) For the spill situations in para- ment-type spills considered in devel- graphs (d)(2)(i) through (vi) of this sec- oping this policy. Thus, cleanups under tion, the responsible party shall decon- other statutes, such as RCRA correc- taminate the spill in accordance with tive actions or remedial and response site-specific requirements established actions under SARA may result in dif- by the EPA regional offices. ferent outcomes. (i) Spills that result in the direct contamination of surface waters (sur- [52 FR 10705, Apr. 2, 1987, as amended at 72 face waters include, but are not limited FR 57241, Oct. 9, 2007; 74 FR 30234, June 25, to, ‘‘waters of the United States’’ as 2009] defined in part 122 of this chapter, § 761.123 Definitions. ponds, lagoons, wetlands, and storage reservoirs). For purposes of this policy, certain (ii) Spills that result in the direct words and phrases are used to denote contamination of sewers or sewage specific materials, procedures, or cir- treatment systems. cumstances. The following definitions (iii) Spills that result in the direct are provided for purposes of clarity and contamination of any private or public are not to be taken as exhaustive lists drinking water sources or distribution of situations and materials covered by systems. the policy. (iv) Spills which migrate to and con- Double wash/rinse means a minimum taminate surface waters, sewers, or requirement to cleanse solid surfaces drinking water supplies before cleanup (both impervious and nonimpervious) has been completed in accordance with two times with an appropriate solvent this policy. or other material in which PCBs are at (v) Spills that contaminate animal least 5 percent soluble (by weight). A grazing lands. volume of PCB-free fluid sufficient to (vi) Spills that contaminate vege- cover the contaminated surface com- table gradens. pletely must be used in each wash/ (e) Relationship of policy to other stat- rinse. The wash/rinse requirement does utes. (1) This policy does not affect not mean the mere spreading of solvent cleanup standards or requirements for or other fluid over the surface, nor does the reporting of spills imposed, or to be the requirement mean a once-over wipe imposed, under other Federal statutory with a soaked cloth. Precautions must authorities, including but not limited be taken to contain any runoff result- to, the Clean Water Act (CWA), the Re- ing from the cleansing and to dispose source Conservation and Recovery Act properly of wastes generated during (RCRA), and the Comprehensive Envi- the cleansing.

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High-concentration PCBs means PCBs Nonimpervious solid surfaces means that contain 500 ppm or greater PCBs, solid surfaces which are porous and are or those materials which EPA requires more likely to absorb spilled PCBs to be assumed to contain 500 ppm or prior to completion of the cleanup re- greater PCBs in the absence of testing. quirements prescribed in this policy. High-contact industrial surface means Nonimpervious solid surfaces include, a surface in an industrial setting which but are not limited to, wood, concrete, is repeatedly touched, often for rel- asphalt, and plasterboard. atively long periods of time. Manned Nonrestricted access areas means any machinery and control panels are ex- area other than restricted access, out- amples of high-contact industrial sur- door electrical substations, and other faces. High-contact industrial surfaces restricted access locations, as defined are generally of impervious solid mate- in this section. In addition to residen- rial. Examples of low-contact indus- tial/commercial areas, these areas in- trial surfaces include ceilings, walls, clude unrestricted access rural areas floors, roofs, roadways and sidewalks (areas of low density development and in the industrial area, utility poles, un- population where access is uncon- manned machinery, concrete pads be- trolled by either man-made barriers or neath electrical equipment, curbing, naturally occurring barriers, such as exterior structural building compo- rough terrain, mountains, or cliffs). nents, indoor vaults, and pipes. Other restricted access (nonsubstation) High-contact residential/commercial sur- locations means areas other than elec- face means a surface in a residential/ trical substations that are at least 0.1 commercial area which is repeatedly kilometer (km) from a residential/com- touched, often for relatively long peri- mercial area and limited by man-made ods of time. Doors, wall areas below 6 barriers (e.g., fences and walls) to sub- feet in height, uncovered flooring, stantially limited by naturally occur- windowsills, fencing, bannisters, stairs, ring barriers such as mountains, cliffs, automobiles, and children’s play areas or rough terrain. These areas generally such as outdoor patios and sidewalks include industrial facilities and ex- are examples of high-contact residen- tremely remote rural locations. (Areas tial/commercial surfaces. Examples of where access is restricted but are less low-contact residential/commercial than 0.1 km from a residential/commer- surfaces include interior ceilings, inte- cial area are considered to be residen- rior wall areas above 6 feet in height, tial/commercial areas.) roofs, asphalt roadways, concrete road- Outdoor electrical substations means ways, wooden utility poles, unmanned outdoor, fenced-off, and restricted ac- machinery, concrete pads beneath elec- cess areas used in the transmission trical equipment, curbing, exterior and/or distribution of electrical power structural building components (e.g., Outdoor electrical substations restrict aluminum/vinyl siding, cinder block, public access by being fenced or walled asphalt tiles), and pipes. off as defined under § 761.30(l)(1)(ii). For Impervious solid surfaces means solid purposes of this TSCA policy, outdoor surfaces which are nonporous and thus electrical substations are defined as unlikely to absorb spilled PCBs within being located at least 0.1 km from a the short period of time required for residential/commercial area. Outdoor cleanup of spills under this policy. Im- fenced-off and restricted access areas pervious solid surfaces include, but are used in the transmission and/or dis- not limited to, metals, glass, alu- tribution of electrical power which are minum siding, and enameled or lami- located less than 0.1. km from a resi- nated surfaces. dential/commercial area are considered Low-concentration PCBs means PCBs to be residential/commercial areas. that are tested and found to contain PCBs means polychlorinated less than 500 ppm PCBs, or those PCB- biphenyls as defined under § 761.3. As containing materials which EPA re- specified under § 761.1(b), no require- quires to be assumed to be at con- ments may be avoided through dilution centrations below 500 ppm (i.e., untest- of the PCB concentration. ed mineral oil dielectric fluid). Requirements and standards means:

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(1) ‘‘Requirements’’ as used in this or on which visible traces of the spilled policy refers to both the procedural re- material are observed is included in sponses and numerical decontamina- the spill area. This area represents the tion levels set forth in this policy as minimum area assumed to be contami- constituting adequate cleanup of PCBs. nated by PCBs in the absence of (2) ‘‘Standards’’ refers to the numer- precleanup sampling data and is thus ical decontamination levels set forth in the minimum area which must be this policy. cleaned. Residential/commercial areas means Spill boundaries means the actual those areas where people live or reside, area of contamination as determined or where people work in other than by postcleanup verification sampling manufacturing or farming industries. or by precleanup sampling to deter- Residential areas include housing and mine actual spill boundaries. EPA can the property on which housing is lo- require additional cleanup when nec- cated, as well as playgrounds, road- essary to decontaminate all areas with- ways, sidewalks, parks, and other simi- in the spill boundaries to the levels re- lar areas within a residential commu- quired in this policy (e.g., additional nity. Commercial areas are typically cleanup will be required if postcleanup accessible to both members of the gen- sampling indicates that the area decon- eral public and employees and include taminated by the responsible party, public assembly properties, institu- such as the spill area as defined in this tional properties, stores, office build- section, did not encompass the actual ings, and transportation centers. boundaries of PCB contamination). Responsible party means the owner of Standard wipe test means, for spills of the PCB equipment, facility, or other high-concentration PCBs on solid sur- source of PCBs or his/her designated faces, a cleanup to numerical surface agent (e.g., a facility manager or fore- standards and sampling by a standard man). wipe test to verify that the numerical Soil means all vegetation, soils and standards have been met. This defini- other ground media, including but not tion constitutes the minimum require- limited to, sand, grass, gravel, and oys- ments for an appropriate wipe testing ter shells. It does not include concrete protocol. A standard-size template (10 and asphalt. centimeters (cm) × 10 cm) will be used Spill means both intentional and un- to delineate the area of cleanup; the intentional spills, leaks, and other un- wiping medium will be a gauze pad or controlled discharges where the release glass wool of known size which has results in any quantity of PCBs run- been saturated with hexane. It is im- ning off or about to run off the exter- portant that the wipe be performed nal surface of the equipment or other very quickly after the hexane is ex- PCB source, as well as the contamina- posed to air. EPA strongly recommends tion resulting from those releases. This that the gauze (or glass wool) be pre- policy applies to spills of 50 ppm or pared with hexane in the laboratory greater PCBs. The concentration of and that the wiping medium be stored PCBs spilled is determined by the PCB in sealed glass vials until it is used for concentration in the material spilled the wipe test. Further, EPA requires as opposed to the concentration of the collection and testing of field PCBs in the material onto which the blanks and replicates. PCBs were spilled. Where a spill of un- [52 FR 10705, Apr. 2, 1987; 52 FR 23397, June 19, tested mineral oil occurs, the oil is pre- 1987] sumed to contain greater than 50 ppm, but less than 500 ppm PCBs and is sub- § 761.125 Requirements for PCB spill ject to the relevant requirements of cleanup. this policy. (a) General. Unless expressly limited, Spill area means the area of soil on the reporting, disposal, and precleanup which visible traces of the spill can be sampling requirements in paragraphs observed plus a buffer zone of 1 foot be- (a) (1) through (3) of this section apply yond the visible traces. Any surface or to all spills of PCBs at concentrations object (e.g., concrete sidewalk or auto- of 50 ppm or greater which are subject mobile) within the visible traces area to decontamination requirements

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under TSCA, including those spills list- ity), but notification of EPA is not re- ed under § 761.120(b) which are excluded quired. from the cleanup standards at para- (2) Disposal of cleanup debris and mate- graphs (b) and (c) of this section. rials. All concentrated soils, solvents, (1) Reporting requirements. The report- rags, and other materials resulting ing in paragraphs (a)(1) (i) through (iv) from the cleanup of PCBs under this of this section is required in addition policy shall be properly stored, labeled, to applicable reporting requirements and disposed of in accordance with the under the Clean Water Act (CWA) or provisions of subpart D of this part. the Comprehensive Environmental Re- (3) Determination of spill boundaries in sponse Compensation and Liability Act the absence of visible traces. For spills of 1980 (CERCLA). For example, under where there are insufficient visible the National Contingency Plan all traces yet there is evidence of a leak or spills involving 1 pound or more by spill, the boundaries of the spill are to weight of PCBs must currently be re- be determined by using a statistically ported to the National Response Center based sampling scheme. (1-800-424-8802). The requirements in (b) Requirements for cleanup of low- paragraphs (a)(1) (i) through (iv) of this concentration spills which involve less section are designed to be consistent than 1 pound of PCBs by weight (less with existing reporting requirements than 270 gallons of untested mineral oil)— to the extent possible so as to mini- (1) Decontamination requirements. Spills mize reporting burdens on governments of less than 270 gallons of untested as well as the regulated community. mineral oil, low-concentration PCBs, (i) Where a spill directly contami- as defined under § 761.123, which involve nates surface water, sewers, or drink- less than 1 pound of PCBs by weight ing water supplies, as discussed under (e.g., less than 270 gallons of untested § 761.120(d), the responsible party shall mineral oil containing less than 500 notify the appropriate EPA regional of- ppm PCBs) shall be cleaned in the fol- fice and obtain guidance for appro- lowing manner: priate cleanup measures in the shortest (i) Solid surfaces must be double possible time after discovery, but in no washed/rinsed (as defined under case later than 24 hours after dis- § 761.123); except that all indoor, resi- covery. dential surfaces other than vault areas (ii) Where a spill directly contami- must be cleaned to 10 micrograms per nates grazing lands or vegetable gar- 100 square centimeters (10 μg/100 cm2) dens, as discussed under § 761.120(d), the by standard commercial wipe tests. responsible party shall notify the ap- (ii) All soil within the spill area (i.e., propriate EPA regional office and pro- visible traces of soil and a buffer of 1 ceed with the immediate requirements lateral foot around the visible traces) specified under paragraph (b) or (c) of must be excavated, and the ground be this section, depending on the source of restored to its original configuration the spill, in the shortest possible time by back-filling with clean soil (i.e., after discovery, but in no case later containing less than 1 ppm PCBs). than 24 hours after discovery. (iii) Requirements of paragraphs (iii) Where a spill exceeds 10 pounds (b)(1) (i) and (ii) of this section must be of PCBs by weight and is not addressed completed within 48 hours after the rein paragraph (a)(1) (i) or (ii) of this sec- sponsible party was notified or became tion, the responsible party will notify aware of the spill. the appropriate EPA regional office (2) Effect of emergency or adverse and proceed to decontaminate the spill weather. Completion of cleanup may be area in accordance with this TSCA pol- delayed beyond 48 hours in case of cir- icy in the shortest possible time after cumstances including but not limited discovery, but in no case later than 24 to, civil emergency, adverse weather hours after discovery. conditions, lack of access to the site, (iv) Spills of 10 pounds or less, which and emergency operating conditions. are not addressed in paragraph (a)(1) (i) The occurrence of a spill on a weekend or (ii) of this section, must be cleaned or overtime costs are not acceptable up in accordance with this policy (in reasons to delay response. Completion order to avoid EPA enforcement liabil- of cleanup may be delayed only for the

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duration of the adverse conditions. If of materials other than low-concentra- the adverse weather conditions, or tion materials shall be considered com- time lapse due to other emergency, has plete if all of the immediate require- left insufficient visible traces, the re- ments, cleanup standards, sampling, sponsible party must use a statistically and recordkeeping requirements of based sampling scheme to determine paragraphs (c) (1) through (5) of this the spill boundaries as required under section are met. paragraph (a)(3) of this section. (1) Immediate requirements. The four (3) Records and certification. At the actions in paragraphs (c)(1) (i) through completion of cleanup, the responsible (iv) of this section must be taken as party shall document the cleanup with quickly as possible and within no more records and certification of decon- than 24 hours (or within 48 hours for tamination. The records and certifi- PCB Transformers) after the respon- cation must be maintained for a period sible party was notified or became of 5 years. The records and certifi- aware of the spill, except that actions cation shall consist of the following: described in paragraphs (c)(1) (ii) (i) Identification of the source of the through (iv) of this section can be de- spill (e.g., type of equipment). layed beyond 24 hours if circumstances (ii) Estimated or actual date and (e.g., civil emergency, hurricane, tor- time of the spill occurrence. nado, or other similar adverse weather (iii) The date and time cleanup was conditions, lack of access due to phys- completed or terminated (if cleanup ical impossibility, or emergency oper- was delayed by emergency or adverse ating conditions) so require for the du- weather: the nature and duration of ration of the adverse conditions. The the delay). occurrence of a spill on a weekend or (iv) A brief description of the spill lo- overtime costs are not acceptable rea- cation. sons to delay response. Owners of (v) Precleanup sampling data used to spilled PCBs who have delayed cleanup establish the spill boundaries if re- because of these types of circumstances quired because of insufficient visible must keep records documenting the traces, and a brief description of the fact that circumstances precluded sampling methodology used to estab- rapid response. lish the spill boundaries. (i) The responsible party shall notify (vi) A brief description of the solid the EPA regional office and the NRC as surfaces cleaned and of the double required by § 761.125(a)(1) or by other wash/rinse method used. applicable statutes. (vii) Approximate depth of soil exca- (ii) The responsible party shall effec- vation and the amount of soil removed. tively cordon off or otherwise delineate (viii) A certification statement and restrict an area encompassing any signed by the responsible party stating visible traces plus a 3-foot buffer and that the cleanup requirements have place clearly visible signs advising per- been met and that the information con- sons to avoid the area to minimize the tained in the record is true to the best spread of contamination as well as the of his/her knowledge. potential for human exposure. (ix) While not required for compli- (iii) The responsible party shall ance with this policy, the following in- record and document the area of visible formation would be useful if main- contamination, noting the extent of tained in the records: the visible trace areas and the center (A) Additional pre- or post-cleanup of the visible trace area. If there are no sampling. visible traces, the responsible party (B) The estimated cost of the cleanup shall record this fact and contact the by man-hours, dollars, or both. regional office of the EPA for guidance (c) Requirements for cleanup of high- in completing statistical sampling of concentration spills and low-concentra- the spill area to establish spill bound- tion spills involving 1 pound or more aries. PCBs by weight (270 gallons or more of (iv) The responsible party shall ini- untested mineral oil). Cleanup of low- tiate cleanup of all visible traces of the concentration spills involving 1 lb or fluid on hard surfaces and initiate re- more PCBs by weight and of all spills moval of all visible traces of the spill

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on soil and other media, such as gravel, jeopardize the integrity of the elec- sand, oyster shells, etc. trical equipment at the substation, the (v) If there has been a delay in reach- EPA regional office may establish an ing the site and there are insufficient alternative cleanup method or level visible traces of PCBs remaining at the and place the responsible party on a spill site, the responsible party must reasonably timely schedule for comple- estimate (based on the amount of mation of cleanup. terial missing from the equipment or (3) Requirements for decontaminating container) the area of the spill and im- spills in other restricted access areas. mediately cordon off the area of sus- Spills which occur in restricted access pect contamination. The responsible locations other than outdoor electrical party must then utilize a statistically substations, as defined under § 761.123, based sampling scheme to identify the shall be decontaminated in accordance boundaries of the spill area as soon as with paragraphs (c)(3) (i) through (v) of practicable. this section. Conformance to the clean- (vi) Although this policy requires up standards in paragraphs (c)(3) (i) certain immediate actions, as de- through (v) of this section shall be scribed in paragraphs (c)(1)(i) through verified by postcleanup sampling as (iv) of this section, EPA is not placing specified under § 761.130. At such times a time limit on completion of the as restricted access areas other than cleanup effort since the time required outdoor electrical substations are con- for completion will vary from case to verted to another use, the spill site case. However, EPA expects that de- shall be cleaned up to the nonrestricted contamination will be achieved access area requirements of paragraph promptly in all cases and will consider (c)(4) of this section. promptness of completion in deter- (i) High-contact solid surfaces, as de- mining whether the responsible party fined under § 761.163 shall be cleaned to made good faith efforts to clean up in 10 μg/100 cm2 (as measured by standard accordance with this policy. wipe tests). (2) Requirements for decontaminating (ii) Low-contact, indoor, impervious spills in outdoor electrical substations. solid surfaces will be decontaminated Spills which occur in outdoor electrical to 10 μg/100 cm2. substations, as defined under § 761.123, (iii) At the option of the responsible shall be decontaminated in accordance party, low-contact, indoor, nonimper- with paragraphs (c)(2) (i) and (ii) of this vious surfaces will be cleaned either to section. Conformance to the cleanup 10 μg/100 cm2 or to 100 μg/100 cm2 and standards under paragraphs (c)(2) (i) encapsulated. The Regional Adminis- and (ii) of this section shall be verified trator, however, retains the authority by post-cleanup sampling as specified to disallow the encapsulation option under § 761.130. At such times as out- for a particular spill situation upon door electrical substations are con- finding that the uncertainties associ- verted to another use, the spill site ated with that option pose special con- shall be cleaned up to the nonrestricted cerns at that site. That is, the Re- access requirements under paragraph gional Administrator would not permit (c)(4) of this section. encapsulation if he/she determined that (i) Contaminated solid surfaces (both if the encapsulation failed the failure impervious and non-impervious) shall would create an imminent hazard at be cleaned to a PCB concentration of the site. 100 micrograms (μg)/100 square centi- (iv) Low-contact, outdoor surfaces meters (cm2) (as measured by standard (both impervious and nonimpervious) wipe tests). shall be cleaned to 100 μg/100 cm2. (ii) At the option of the responsible (v) Soil contaminated by the spill party, soil contaminated by the spill will be cleaned to 25 ppm PCBs by will be cleaned either to 25 ppm PCBs weight. by weight, or to 50 ppm PCBs by weight (4) Requirements for decontaminating provided that a label or notice is visi- spills in nonrestricted access areas. Spills bly placed in the area. Upon dem- which occur in nonrestricted access lo- onstration by the responsible party cations, as defined under § 761.123, shall that cleanup to 25 ppm or 50 ppm will be decontaminated in accordance with

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paragraphs (c)(4) (i) through (v) of this weather: the nature and duration of section. Conformance to the cleanup the delay). standards at paragraphs (c)(4) (i) (iv) A brief description of the spill lo- through (v) of this section shall be cation and the nature of the materials verified by postcleanup sampling as contaminated. This information should specified under § 761.130. include whether the spill occurred in (i) Furnishings, toys, and other eas- an outdoor electrical substation, other ily replaceable household items shall restricted access location, or in a non- be disposed of in accordance with the restricted access area. provisions of subpart D of this part and (v) Precleanup sampling data used to replaced by the responsible party. establish the spill boundaries if re- (ii) Indoor solid surfaces and high- quired because of insufficient visible contact outdoor solid surfaces, defined traces and a brief description of the as high contact residential/commercial sampling methodology used to estab- surfaces under § 761.123, shall be cleaned lish the spill boundaries. to 10 μg/100 cm2 (as measured by stand- (vi) A brief description of the solid ard wipe tests). surfaces cleaned. (iii) Indoor vault areas and low-con- (vii) Approximate depth of soil exca- tact, outdoor, impervious solid surfaces vation and the amount of soil removed. shall be decontaminated to 10 μg/100 (viii) Postcleanup verification sam- cm2. pling data and, if not otherwise appar- (iv) At the option of the responsible ent from the documentation, a brief de- party, low-contact, outdoor, nonimper- scription of the sampling methodology vious solid surfaces shall be either and analytical technique used. cleaned to 10 μg/100 cm2 or cleaned to (ix) While not required for compli- 100 μg/100 cm2 and encapsulated. The ance with this policy, information on Regional Administrator, however, re- the estimated cost of cleanup (by man- tains the authority to disallow the en- hours, dollars, or both) would be useful capsulation option for a particular spill if maintained in the records. situation upon finding that the uncer- [52 FR 10705, Apr. 2, 1987, as amended at 53 tainties associated with that option FR 40884, Oct. 19, 1988; 63 FR 35461, June 29, pose special concerns at that site. That 1998; 72 FR 57241, Oct. 9, 2007] is, the Regional Administrator would not permit encapsulation if he/she de- § 761.130 Sampling requirements. termined that if the encapsulation Postcleanup sampling is required to failed the failure would create an im- verify the level of cleanup under minent hazard at the site. § 761.125(c) (2) through (4). The respon- (v) Soil contaminated by the spill sible party may use any statistically will be decontaminated to 10 ppm PCBs valid, reproducible, sampling scheme by weight provided that soil is exca- (either random samples or grid sam- vated to a minimum depth of 10 inches. ples) provided that the requirements of The excavated soil will be replaced paragraphs (a) and (b) of this section with clean soil, i.e., containing less are satisfied. than 1 ppm PCBs, and the spill site will (a) The sampling area is the greater be restored (e.g., replacement of turf). of (1) an area equal to the area cleaned (5) Records. The responsible party plus an additional 1-foot boundary, or shall document the cleanup with (2) an area 20 percent larger than the records of decontamination. The original area of contamination. records must be maintained for a pe- (b) The sampling scheme must ensure riod of 5 years. The records and certifi- 95 percent confidence against false cation shall consist of the following: positives. (i) Identification of the source of the (c) The number of samples must be spill, e.g., type of equipment. sufficient to ensure that areas of con- (ii) Estimated or actual date and tamination of a radius of 2 feet or more time of the spill occurrence. within the sampling area will be de- (iii) The date and time cleanup was tected, except that the minimum num- completed or terminated (if cleanup ber of samples is 3 and the maximum was delayed by emergency or adverse number of samples is 40.

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(d) The sampling scheme must in- § 761.135 Effect of compliance with clude calculation for expected varia- this policy and enforcement. bility due to analytical error. (a) Although a spill of material con- (e) EPA recommends the use of a taining 50 ppm or greater PCBs is con- sampling scheme developed by the Mid- sidered improper PCB disposal, this west Research Institute (MRI) for use policy establishes requirements that in enforcement inspections: EPA considers to be adequate cleanup ‘‘Verification of PCB Spill Cleanup by of the spilled PCBs. Cleanup in accord- Sampling and Analysis.’’ Guidance for ance with this policy means compli- the use of this sampling scheme is ance with the procedural as well as the available in the MRI report ‘‘Field numerical requirements of this policy. Manual for Grid Sampling of PCB Spill Compliance with this policy creates a Sites to Verify Cleanup.’’ Both the MRI presumption against both enforcement sampling scheme and the guidance doc- action for penalties and the need for ument are available on EPA’s PCB Web further cleanup under TSCA. The site at http://www.epa.gov/pcb, or from Agency reserves the right, however, to the Program Management, Commu- initiate appropriate action to compel nications, and Analysis Office, Office of cleanup where, upon review of the Resource Conservation and Recovery records of cleanup or EPA sampling (5305P), 1200 Pennsylvania Ave., NW., following cleanup, EPA finds that the Washington, DC 20460–0001. The major decontamination levels in the policy advantage of this sampling scheme is have not been achieved. The Agency that it is designed to characterize the also reserves the right to seek pen- degree of contamination within the en- alties where the Agency believes that tire sampling area with a high degree the responsible party has not made a of confidence while using fewer sam- good faith effort to comply with all ples than any other grid or random provisions of this policy, such as sampling scheme. This sampling prompt notification of EPA of a spill, scheme also allows some sites to be recordkeeping, etc. characterized on the basis of composite (b) EPA’s exercise of enforcement samples. discretion does not preclude enforce- (f) EPA may, at its discretion, take ment action under other provisions of samples from any spill site. If EPA’s TSCA or any other Federal statute. sampling indicates that the remaining This includes, even in cases where the concentration level exceeds the re- numerical decontamination levels set quired level, EPA will require further forth in this policy have been met, civil cleanup. For this purpose, the numer- or criminal action for penalties where ical level of cleanup required for spills EPA believes the spill to have been the cleaned in accordance with § 761.125(b) result of gross negligence or knowing is deemed to be the equivalent of nu- violation. merical cleanup requirements required for cleanups under § 761.125(c) (2) through (4). Using its best engineering Subparts H–I [Reserved] judgment, EPA may sample a statistically valid random or grid sampling Subpart J—General Records and technique, or both. When using engi- Reports neering judgment or random ‘‘grab’’ samples, EPA will take into account § 761.180 Records and monitoring. that there are limits on the power of a This section contains recordkeeping grab sample to dispute statistically and reporting requirements that apply based sampling of the type required of to PCBs, PCB Items, and PCB storage the responsible party. EPA head- and disposal facilities that are subject quarters will provide guidance to the to the requirements of the part. EPA regions on the degree of certainty (a) PCBs and PCB Items in service or associated with various grab sample re- projected for disposal. Beginning Feb- sults. ruary 5, 1990, each owner or operator of [52 FR 10705, Apr. 2, 1987, as amended at 60 a facility, other than a commercial FR 34465, July 3, 1995; 72 FR 57241, Oct. 9, storer or a disposer of PCB waste, 2007; 74 FR 30234, June 25, 2009] using or storing at any one time at

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least 45 kilograms (99.4 pounds) of each manifest and for unmanifested PCBs contained in PCB Container(s), or waste that may be stored at the facil- one or more PCB Transformers, or 50 or ity, the following information: more PCB Large High or Low Voltage (A) For bulk PCB waste (e.g., in a Capacitors shall develop and maintain tanker or truck), its weight in kilo- at the facility, or a central facility programs, the first date it was removed vided they are maintained at that fa- from service for disposal, the date it cility, all annual records and the writ- was placed into transport for off-site ten annual document log of the disposi- storage or disposal, and the date of dis- tion of PCBs and PCB Items. The writ- posal, if known. ten annual document log must be pre- (B) The serial number (if available) pared for each facility by July 1 cov- or other means of identifying each PCB ering the previous calendar year (Janu- Article (e.g., transformer or capacitor), ary through December). The annual the weight in kilograms of the PCB document log shall be maintained for waste in each transformer or capacitor, at least 3 years after the facility ceases the date it was removed from service using or storing PCBs and PCB Items for disposal, the date it was placed in in the quantities prescribed in this transport for off-site storage or dis- paragraph. Annual records (manifests posal, and the date of disposal, if and certificates of disposal) shall be known. maintained for the same period. The (C) A unique number identifying each annual records and the annual docu- PCB Container, a description of the ment log shall be available for inspec- contents of each PCB Container, such tion at the facility where they are as liquid, soil, cleanup debris, etc., in- maintained by authorized representa- cluding the total weight of the mate- tives of EPA during normal business rial in kilograms in each PCB Con- hours, and each owner or operator of a tainer, the first date material placed in facility subject to these requirements each PCB Container was removed from shall know the location of these service for disposal, and the date each records. All records and annual docu- PCB Container was placed in transport ments required to be prepared and for off-site storage or disposal, and the maintained by this section prior to date of disposal (if known). February 5, 1990 shall continue to be (D) A unique number identifying each maintained at the facility for the same PCB Article Container, a description of time as the annual records and the an- the contents of each PCB Article Con- nual document log. The annual docu- tainer, such as pipes, capacitors, elec- ment required for 1989 shall cover the tric motors, pumps, etc., including the period from January 1, 1989 to Feb- total weight in kilograms of the con- ruary 5, 1990. tent of each PCB Article Container, the (1) The annual records shall include first date a PCB Article placed in each the following: PCB Article Container was removed (i) All signed manifests generated by from service for disposal, and the date the facility during the calendar year. the PCB Article Container was placed (ii) All Certificates of Disposal that in transport for off-site storage or dis- have been received by the facility dur- posal, and the date of disposal (if ing the calendar year. known.) (iii) Records of inspections and clean- (iii) The total number by specific ups performed in accordance with type of PCB Articles and the total § 761.65(c)(5). weight in kilograms of PCBs in PCB (2) The written annual document log Articles, the total number of PCB Arti- shall include the following: cle Containers and total weight in kilo- (i) The name, address, and EPA iden- grams of the contents of PCB Article tification number of the facility cov- Containers, the total number of PCB ered by the annual document log and Containers and the total weight in the calendar year covered by the an- kilograms of the contents of PCB Con- nual document log. tainers, and the total weight in kilo- (ii) The unique manifest number of grams of bulk PCB waste that was every manifest generated by the facil- placed into storage for disposal or dis- ity during the calendar year, and from posed during the calendar year.

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(iv) The total number of PCB Trans- PCBs and PCB Items that were handled formers and total weight in kilograms as PCB waste at the facility. The writ- of PCBs contained in the transformers ten annual document log shall be pre- remaining in service at the end of the pared by July 1 for the previous cal- calendar year. endar year (January through Decem- (v) The total number of Large High ber). The written annual document log or Low Voltage PCB Capacitors re- shall be maintained at each facility for maining in service at the end of the at least 3 years after the facility is no calendar year. longer used for the storage or disposal (vi) The total weight in kilograms of of PCBs and PCB Items except that, in any PCBs and PCB Items in PCB Con- the case of chemical waste landfills, tainers, including the identification of the annual document log shall be main- container contents, remaining in serv- tained at least 20 years after the chem- ice at the facility at the end of the cal- ical waste landfill is no longer used for endar year. the disposal of PCBs and PCB Items. (vii) For any PCBs or PCB item re- The annual records shall be maintained ceived from or shipped to another facil- for the same period. The annual ity owned or operated by the same gen- records and written annual document erator, the information required under log shall be available at the facility for paragraph (a)(2)(ii)(A) through inspection by authorized representa- (a)(2)(ii)(D) of this section. tives of the EPA. All records and an- (viii) A record of each telephone call, nual documents required to be prepared or other means of verification agreed and maintained by this section prior to upon by both parties, made to each des- February 5, 1990 shall continue to be ignated commercial storer or des- maintained at the facility for the same ignated disposer to confirm receipt of time as the annual records and the an- PCB waste transported by an inde- nual document log. The annual docu- pendent transporter, as required by ment for 1989 shall cover the period § 761.208. from January 1, 1989 to February 5, (ix) Whenever a PCB Item, excluding 1990. From the written annual docu- small capacitors, with a concentration ment log the owner or operator of a fa- of ≥50 ppm is distributed in commerce cility must prepare the annual report for reuse pursuant to § 761.20(c)(1), the containing the information required by name, address, and telephone number paragraphs (b)(3)(i) through (b)(3)(vi) of of the person to whom the item was this section for PCBs and PCB Items transferred, date of transfer, and the that were handled as PCB waste at the serial number of the item or the inter- facility during the previous calendar nal identification number, if a serial year (January through December). The number is not available, must be re- annual report must be submitted by corded in the annual document log. July 15 of each year for the preceding The serial number or internal identi- calendar year. If the facility ceases fication number shall be permanently commercial PCB storage or disposal marked on the equipment. operations, the owner or operator of (3) [Reserved] the facility shall provide at least 60 (4) For purposes of this paragraph, days advance written notice to the Re- PCB Voltage Regulators shall be regional Administrator for the region in corded as PCB Transformers. which the facility is located of the date (b) Disposers and commercial storers of the facility intends to begin closure. d PCB waste. Beginning February 5, 1990, (1) The annual records shall include each owner or operator of a facility (in- the following: cluding high efficiency boiler oper- (i) All signed manifests generated or ations) used for the commercial stor- received at the facility during the cal- age or disposal of PCBs and PCB Items endar year. shall maintain annual records on the (ii) All Certificates of Disposal that disposition of all PCBs and PCB items have been generated or received by the at the facility and prepare and main- facility during the calendar year. tain a written annual document log (iii) Records of inspections and clean- that includes the information required ups performed in accordance with by paragraphs (b)(2) of this section for § 761.65(c)(5).

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(2) The written annual document log date it was received at the facility, the shall include the following: date each PCB Article Container was (i) The name, address, and EPA iden- placed in transport for off-site storage tification number of the storage or dis- or disposal (as applicable), and the date posal facility covered by the annual the PCB Article Container was dis- document log and the calendar year posed of (if known). covered by the annual document log. (E) Disposers of PCB waste shall in- (ii) For each manifest generated or clude the confirmed date of disposal for received by the facility during the cal- items in paragraphs (b)(2)(ii)(A) endar year, the unique manifest num- through (b)(2)(ii)(D) of this section. ber and the name and address of the fa- (iii) For any PCB waste disposed at a cility that generated the manifest and facility that generated the PCB waste the following information: or any PCB waste that was not mani- (A) For bulk PCB waste (e.g., in a fested to the facility, the information tanker or truck), its weight in kilo- required under paragraph (b)(2)(ii)(A) grams, the first date PCB waste placed through (b)(2)(ii)(E) of this section. in the tanker or truck was removed (3) The owner or operator of a PCB from service for disposal, the date it disposal facility (including an owner or was received at the facility, the date it operator who disposes of his/her own was placed in transport for off-site dis- waste and does not receive or generate posal (if applicable), and the date of manifests) or a commercial storage fa- disposal, (if known ). cility shall submit an annual report, (B) The serial number or other means which briefly summarizes the records of identifying each PCB Article, not in and annual document log required to a PCB Container or PCB Article Con- be maintained and prepared under tainer, the weight in kilograms of the paragraphs (b)(1) and (b)(2) of this sec- PCB waste in the PCB Article, the date tion to the EPA Regional Adminis- it was removed from service for dis- trator of the Region in which the facil- posal, the date it was received at the ity is located by July 15 of each year, facility, the date it was placed in beginning with July 15, 1991. The first transport for off-site disposal (if appli- annual report submitted on July 15, cable), and the date of disposal (if 1991, shall be for the period starting known). February 5, 1990, and ending December (C) The unique number assigned by 31, 1990. The annual report shall con- the generator identifying each PCB tain no confidential business informa- Container, a description of the con- tion. The annual report shall consist of tents of each PCB Container, such as the information listed in paragraphs liquid, soil, cleanup debris, etc., includ- (b)(3)(i) through (b)(3)(vi) of this sec- ing the total weight of the PCB waste tion. in kilograms in each PCB Container, (i) The name, address, and EPA iden- the first date PCB waste placed in each tification number of the facility cov- PCB Container was removed from serv- ered by the annual report for the cal- ice for disposal, the date it was re- endar year. ceived at the facility, the date each (ii) A list of the numbers of all signed PCB Container was placed in transport manifests of PCB waste initiated or re- for off-site storage or disposal (as ap- ceived by the facility during that year. plicable), and the date the PCB Con- (iii) The total weight in kilograms of tainer was disposed of (if known). bulk PCB waste, PCB waste in PCB (D) The unique number assigned by Transformers, PCB waste in PCB Large the generator identifying each PCB Ar- High or Low Voltage Capacitors, PCB ticle Container, a description of the waste in PCB Article Containers, and contents of each PCB Article Con- PCB waste in PCB Containers in stor- tainer, such as pipes, capacitors, elec- age at the facility at the beginning of tric motors, pumps, etc., including the the calendar year, received or gen- total weight in kilograms of the PCB erated at the facility, transferred to waste in each PCB Article Container, another facility, or disposed of at the the first date a PCB Article placed in facility during the calendar year. The each PCB Article Container was re- information must be provided for each moved from service for disposal, the of these categories, as appropriate.

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(iv) The total number of PCB Trans- corded and reported as PCB Trans- formers, the total number of PCB formers. Large High or Low Voltage Capacitors, (c) Incineration facilities. Each owner the total number of PCB Article Con- or operator of a PCB incinerator facil- tainers, and the total number of PCB ity shall collect and maintain for a pe- Containers in storage at the facility at riod of 5 years from the date of collec- the beginning of the calendar year, re- tion the following information, in addi- ceived or generated at the facility, tion to the information required in transferred to another facility, or dis- paragraph (b) of this section: posed of at the facility during the cal- (1) When PCBs are being incinerated, endar year. The information must be the following continuous and short-in- provided for each of these categories, terval data: as appropriate. (i) Rate and quantity of PCBs fed to (v) The total weight in kilograms of the combustion system as required in each of the following PCB categories: § 761.70(a)(3); bulk PCB waste, PCB waste in PCB (ii) Temperature of the combustion Transformers, PCB waste in PCB Large process as required in § 761.70(a)(4); and High or Low Voltage Capacitors, PCB (iii) Stack emission product to in- waste in PCB Article Containers, and clude O2, CO, and CO2 as required in PCB waste in PCB Containers remain- § 761.70(a)(7). ing in storage for disposal at the facil- (2) When PCBs are being incinerated, ity at the end of the calendar year. data and records on the monitoring of (vi) The total number of PCB Trans- stack emissions as required in formers, the total number of PCB § 761.70(a)(6). Large High or Low Voltage Capacitors, (3) Total weight in kilograms of any the total number of PCB Article Con- solid residues generated by the inciner- tainers, and the total number of PCB ation of PCBs and PCB Items during Containers remaining in storage for the calendar year, the total weight in disposal at the facility at the end of kilograms of any solid residues dis- the calendar year. posed of by the facility in chemical (vii) The requirement to submit an- waste landfills, and the total weight in nual reports to the Regional Adminis- kilograms of any solid residues remain- trator continues until the submission ing on the facility site. of the annual report for the calendar (4) When PCBs and PCB Items are year during which the facility ceases being incinerated, additional periodic PCB storage or disposal operations. data shall be collected and maintained Storage operations have not ceased as specified by the Regional Adminis- until all PCB waste, including any PCB trator pursuant to § 761.70(d)(4). waste generated during closure, has (5) Upon any suspension of the oper- been removed from the facility. ation of any incinerator pursuant to (4) Whenever a commercial storer of § 761.70(a)(8), the owner or operator of PCB waste accepts PCBs or PCB Items such an incinerator shall prepare a doc- at his storage facility and transfers the ument. The document shall, at a min- PCB waste off-site to another facility imum, include the date and time of the for storage or disposal, the commercial suspension and an explanation of the storer of PCB waste shall initiate a circumstances causing the suspension manifest under subpart K of this part of operation. The document shall be for the transfer of PCBs or PCB Items sent to the appropriate Regional Ad- to the next storage or disposal facility. ministrator within 30 days of any such NOTE: Any requirements for weights in suspension. kilograms of PCBs may be calculated values (d) Chemical waste landfill facilities. if the internal volume of PCBs in containers Each owner or operator of a PCB chem- and transformers is known and included in ical waste landfill facility shall collect the reports, together with any assumptions on the density of the PCBs contained in the and maintain until at least 20 years containers or tranformers. If the internal after the chemical waste landfill is no volume of PCBs is not known, a best esti- longer used for the disposal of PCBs mate may be used. the following information in addition (5) For purposes of this paragraph, to the information required in para- PCB Voltage Regulators shall be re- graph (b) of this section:

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(1) Any water analysis obtained in procedures in § 761.30(a)(2)(v) or compliance with § 761.75(b)(6)(iii); and § 761.30(h)(2)(v), you must keep records (2) Any operations records including showing that you followed the required burial coordinates of wastes obtained reclassification procedures. Where in compliance with § 761.75(b)(8)(ii). these procedures require testing, the (e) High efficiency boiler facilities. records must include copies of pre- and Each owner or operator of a high effi- post-reclassification PCB concentra- ciency boiler used for the disposal of tion measurements from a laboratory liquids between 50 and 500 ppm PCB using quality control and quality as- shall collect and maintain for a period surance procedures. You must make of 5 years the following information, in these records available promptly to addition to the information required in EPA or to any party possessing the paragraph (b) of this section: equipment through sale, loan, lease, or (1) For each month PCBs are burned for servicing. You must retain the in the boiler the carbon monoxide and records for at least 3 years after you excess oxygen data required in sell or dispose of the equipment. § 761.71(a)(1)(viii) and § 761.71(b)(1)(viii); (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C. (2) The quantity of PCBs burned each 2605) month as required in § 761.71(a)(1)(vii) and § 761.71(b)(1)(vii); and [44 FR 31542, May 31, 1979. Redesignated at 47 (3) For each month PCBs (other than FR 19527, May 6, 1982, and further redesig- mineral oil dielectric fluid) are burned, nated at 47 FR 37360, Aug. 25, 1982; 49 FR 28191, July 10, 1984; 53 FR 12524, Apr. 15, 1988; chemical analysis data of the waste as 54 FR 52750, Dec. 21, 1989; 55 FR 26205, June required in § 761.71(b)(2)(vi). 27, 1990; 58 FR 34205, June 23, 1993; 63 FR (f) Retention of special records by stor- 35461, June 29, 1998; 66 FR 17619, Apr. 2, 2001] age and disposal facilities. In addition to the information required to be main- § 761.185 Certification program and retained under paragraphs (b), (c), (d) and tention of records by importers and (e) of this section, each owner or oper- persons generating PCBs in ex- ator of a PCB storage or disposal facil- cluded manufacturing processes. ity (including high efficiency boiler op- (a) In addition to meeting the basic erations) shall collect and maintain for requirements of § 761.1(f) and the defini- the time period specified in paragraph tion of excluded manufacturing proc- (b) of this section the following data: esses at § 761.3, manufacturers with (1) All documents, correspondence, processes inadvertently generating and data that have been provided to PCBs and importers of products con- the owner or operator of the facility by taining inadvertently generated PCBs any State or local government agency must report to EPA any excluded man- and that pertain to the storage or dis- ufacturing process or imports for which posal of PCBs and PCB Items at the fa- the concentration of PCBs in products cility. leaving the manufacturing site or im- (2) All documents, correspondence, ported is greater than 2 micrograms and data that have been provided by per gram (2 μg/g, roughly 2 ppm) for the owner or operator of the facility to any resolvable gas chromatographic any State or local government agency peak. Such reports must be filed by Oc- and that pertain to the storage or dis- tober 1, 1984 or, if no processes or im- posal of PCBs and PCB Items at the fa- ports require reports at the time, with- cility. in 90 days of having processes or im- (3) Any applications and related cor- ports for which such reports are re- respondence sent by the owner or oper- quired. ator of the facility to any local, State, (b) Manufacturers required to report or Federal authorities in regard to by paragraph (a) of this section must waste water discharge permits, solid transmit a letter notifying EPA of the waste permits, building permits, or number, the type, and the location of other permits or authorizations such as excluded manufacturing processes in those required by §§ 761.70(d) and which PCBs are generated when the 761.75(c). PCB level in products leaving any man- (g) Reclassification records. If you re- ufacturing site is greater than 2 μg/g classify electrical equipment using the for any resolvable gas chromatographic

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peak. Importers required to report by (d) The certification required by paragraph (a) of this section must paragraph (b) of this section must be transmit a letter notifying EPA of the signed by a responsible corporate offi- concentration of PCBs in imported cer. This certification must be main- products when the PCB concentration tained by each facility or importer for of products being imported is greater a period of three years after ceasing than 2 μg/g for any resolvable gas process operation or importation, or chromatographic peak. Persons must for seven years, whichever is shorter, also certify the following: and must be made available to EPA (1) Their compliance with all applica- upon request. For the purpose of this ble requirements of § 761.1(f), including section, a responsible corporate officer any applicable requirements for air and means: water releases and process waste dis- (1) A president, secretary, treasurer, posal. or vice-president of the corporation in (2) Whether determinations of com- charge of a principal business function, pliance are based on actual monitoring or any other person who performs simi- of PCB levels or on theoretical assess- lar policy or decision-making functions ments. for the corporation. (3) That such determinations of com- (2) The manager of one or more man- pliance are being maintained. ufacturing, production, or operating fa- (4) If the determination of compli- cilities employing more than 250 per- ance is based on a theoretical assess- sons or having gross annual sales or ex- ment, the letter must also notify EPA penditures exceeding $25,000,000 (in sec- of the estimated PCB concentration ond quarter 1980 dollars), if authority levels generated and released. to sign documents has been assigned or (c) Any person who reports pursuant delegated to the manager in accord- to paragraph (a) of this section: ance with corporate procedures. (1) Must have performed either a the- (e) Any person signing a document oretical analysis or actual monitoring under paragraph (d) of this section of PCB concentrations. shall also make the following certifi- (2) Must maintain for a period of cation: three years after ceasing process oper- I certify under penalty of law that this ations or importation, or for seven document and all attachments were prepared years, whichever is shorter, records under my direction or supervision in accord- containing the following information: ance with a system designed to assure that (i) Theoretical analysis. Manufacturers qualified personnel properly gather and records must include: the reaction or evaluate information. Based on my inquiry of the person or persons directly responsible reactions believed to be generating for gathering information, the information PCBs; the levels of PCBs generated; is, to the best of my knowledge and belief, and the levels of PCBs released. Im- true, accurate, and complete. I am aware porters records must include: the reac- that there are significant penalties for fal- tion or reactions believed to be gener- sifying information, including the possibility ating PCBs and the levels of PCBs gen- of fines and imprisonment for knowing viola- erated; the basis for all estimations of tions. PCB concentrations; and the name and Dated: llllllllllllllllllll qualifications of the person or persons Signature: llllllllllllllllll performing the theoretical analysis; or (f) This report must be submitted to (ii) Actual monitoring. (A) The method the Document Control Office (DCO) of analysis. (7407M), Office of Pollution Prevention (B) The results of the analysis, in- and Toxics (OPPT), Environmental cluding data from the Quality Assur- Protection Agency, 1200 Pennsylvania ance Plan. Ave., NW., Washington, DC 20460–0001, (C) Description of the sample matrix. ATTN: PCB Notification. This report (D) The name of the analyst or ana- must be submitted by October 1, 1984 or lysts. within 90 days of starting up processes (E) The date and time of the analysis. or commencing importation of PCBs. (F) Numbers for the lots from which (g) This certification process must be the samples are taken. repeated whenever process conditions

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are significantly modified to make the Ave., NW., Washington, DC 20460–0001, previous certification no longer valid. ATTN: PCB Notification. (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C. (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C. 2605) 2605) [49 FR 28191, July 10, 1984; 49 FR 33019, Aug. [49 FR 28192, July 10, 1984, as amended at 53 20, 1984, as amended at 53 FR 12524, Apr. 15, FR 12524, Apr. 15, 1988; 58 FR 34205, June 23, 1988; 58 FR 34205, June 23, 1993; 59 FR 33697, 1993; 59 FR 33697, June 30, 1994; 60 FR 34465, June 30, 1994; 60 FR 34465, July 3, 1995; 71 FR July 3, 1995; 71 FR 33642, June 12, 2006] 33642, June 12, 2006] § 761.193 Maintenance of monitoring § 761.187 Reporting importers and by records by persons who import, persons generating PCBs in ex- manufacture, process, distribute in cluded manufacturing processes. commerce, or use chemicals con- In addition to meeting the basic retaining inadvertently generated quirements of § 761.1(f) and the defini- PCBs. tion of excluded manufacturing process (a) Persons who import, manufac- at § 761.3, PCB-generating manufacture, process, distribute in commerce, turing processes or importers of PCB- or use chemicals containing PCBs containing products shall be considered present as a result of inadvertent gen- ‘‘excluded manufacturing processes’’ eration or recycling who perform any only when the following conditions are actual monitoring of PCB concentra- met: tions must maintain records of any (a) Data are reported to the EPA by such monitoring for a period of three the owner/operator or importer con- years after a process ceases operation cerning the total quantity of PCBs in or importing ceases, or for seven years, product from excluded manufacturing whichever is shorter. processes leaving any manufacturing (b) Monitoring records maintained site in any calendar year when such pursuant to paragraph (a) of this sec- quantity exceeds 0.0025 percent of that tion must contain: site’s rated capacity for such manufac- (1) The method of analysis. turing processes as of October 1, 1984; (2) The results of the analysis, in- or the total quantity of PCBs imported cluding data from the Quality Assur- in any calendar year when such quan- ance Plan. tity exceeds 0.0025 percent of the aver- (3) Description of the sample matrix. age total quantity of such product con- (4) The name of the analyst or ana- taining PCBs imported by such im- lysts. porter during the years 1978, 1979, 1980, (5) The date and time of the analysis. 1981 and 1982. (6) Numbers for the lots from which (b) Data are reported to the EPA by the samples are taken. the owner/operator concerning the (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C. total quantity of inadvertently gen- 2605) erated PCBs released to the air from excluded manufacturing processes at [49 FR 28193, July 10, 1984, as amended at 58 FR 34205, June 23, 1993] any manufacturing site in any calendar year when such quantity exceeds 10 pounds. Subpart K—PCB Waste Disposal (c) Data are reported to the EPA by Records and Reports the owner/operator concerning the total quantity of inadvertently gen- SOURCE: 54 FR 52752, Dec. 21, 1989, unless erated PCBs released to water from ex- otherwise noted. cluded manufacturing processes from any manufacturing site in any calendar § 761.202 EPA identification numbers. year when such quantity exceeds 10 (a) General. Any generator, commer- pounds. cial storer, transporter, or disposer of (d) These reports must be submitted PCB waste who is required to have an to the Document Control Office (DCO) EPA identification number under this (7407M), Office of Pollution Prevention subpart must notify EPA of his/her and Toxics (OPPT), Environmental PCB waste handling activities, using Protection Agency, 1200 Pennsylvania the notification procedures and form

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described in § 761.205. EPA will confirm identification number in accordance the EPA identification number of fa- with the applicable notification proce- cilities already assigned one, and will dures of § 761.205. Such persons shall assign an EPA identification number use the EPA identification number ‘‘40 to facilities that do not have one. CFR PART 761,’’ or a number assigned (b) Prohibitions. After June 4, 1990: to the persons by EPA or a State under (1) A generator of PCB waste shall RCRA, until EPA issues to such per- not: sons a specific identification number (i) Process, store, dispose of, trans- under § 761.205(a), (b), or (c). port, or offer for transportation PCB (d) PCB waste first handled after effec- waste without having received an EPA tive date of this subpart. Generators identification number from the Agen- (other than generators exempt from cy. A generator of PCB waste who is notification under § 761.205(c)(1)), com- exempted from notification under mercial storers, transporters, and dis- § 761.205(c)(1) or who notifies EPA in a posers of PCB waste who are required timely manner under § 761.205(c)(2)(i), to have EPA identification numbers but has not yet received a unique iden- under this subpart, and who first en- tification number, shall be regarded as gage in PCB waste activities after Feb- having received from EPA the identi- ruary 5, 1990, are subject to the prohibi- fication number ‘‘40 CFR PART 761.’’ tions in paragraph (b) of this section. (ii) Offer the PCB waste to transporters, disposers, or commercial stor- § 761.205 Notification of PCB waste ac- ers of PCB waste who have not received tivity (EPA Form 7710–53). an EPA identification number. (a)(1) All commercial storers, trans- (2) A transporter of PCB waste shall porters, and disposers of PCB waste not: who were engaged in PCB waste han- (i) Transport PCB waste without hav- dling activities on or prior to February ing received an EPA identification 5, 1990 shall notify EPA of their PCB number from EPA. waste activities by filing EPA Form (ii) Deliver PCB waste to trans- 7710–53 with EPA by no later than April porters, disposers, or commercial stor- 4, 1990. Upon receiving the notification ers of PCB waste that have not re- form, EPA will assign an EPA identi- ceived an EPA identification number. fication number to each entity that no- (3) A commercial storer of PCB waste tifies. shall not accept any PCB waste for (2) All generators (other than genera- storage without having received an tors exempt from notification under EPA identification number from EPA. paragraph (c)(1) of this section), com- (4) A disposer of PCB waste shall not mercial storers, transporters, and dis- accept any PCB waste for disposal posers of PCB waste who first engage without having received an EPA identi- in PCB waste handling activities after fication number from EPA. A disposer February 5, 1990, shall notify EPA of of PCB waste who owns more than one their PCB waste activities by filing disposal facility or mobile treatment EPA Form 7710–53 with EPA prior to unit shall not accept waste unless the engaging in PCB waste handling activi- disposer has received an EPA identities. fication number for each facility or (3) Any person required to notify mobile unit. EPA under this section shall file with (c) PCB waste handled prior to effective EPA Form 7710–53. Copies of EPA Form date of this subpart. Generators (other 7710–53 are available on EPA’s Web site than generators exempt from notifica- at http://www.epa.gov/pcb, or from the tion under § 761.205(c)(1)), commercial Program Management, Communica- storers, transporters, and disposers of tions, and Analysis Office, Office of Re- PCB waste who are required to have source Conservation and Recovery EPA identification numbers under this (5305P), Environmental Protection subpart, and who were engaged in PCB Agency, 1200 Pennsylvania Ave., NW., waste handling activities on or prior to Washington, DC 20460–0001. Descriptive February 5, 1990, are not subject to the information and instructions for filling prohibitions of paragraph (b) of this in the form are included in paragraphs section if they have applied for an EPA (a)(4)(i) through (vii) of this section.

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(4) All of the following information unless such generators elect to use a shall be provided to EPA on Form 7710– unique EPA identification number pre- 53: viously assigned to them under RCRA (i) The name of the facility, and the by EPA or a State. name of the owner or operator of the (2) Generators of PCB waste who use, facility. own, service, or process PCBs or PCB (ii) EPA identification number, if Items shall notify EPA of their PCB any, previously issued to the facility. waste activities only if they own or op- (iii) The facility’s mailing address. erate PCB storage facilities subject to (iv) The location of the facility. the storage requirements of § 761.65 (b) (v) The facility’s installation contact or (c)(7). Such generators shall notify and telephone number. EPA in the following manner: (vi) The type of PCB waste activity (i) Generators storing PCB waste sub- engaged in at the facility. ject to the storage requirements of (vii) Signature of the signer of the § 761.65 (b) or (c)(7) shall notify EPA by certification statement, typed or print- filing EPA Form 7710–53 with EPA by ed name and official title of signer, and no later than April 4, 1990. date signed. (ii) Generators who desire to com- (viii) EPA has determined that the mence storage of PCB waste after Feb- information in paragraphs (a)(4)(i) ruary 5, 1990 shall notify EPA and re- through (a)(4)(vii) of this section shall ceive an EPA identification number be- not be treated as confidential business fore they may commence storage of information. This information will be PCBs at their facilities established disclosed to the public without further under § 761.65 (b) or (c)(7). notice to the submitter unless the sub- (iii) A separate notification shall be mitter provides a written justification submitted to EPA for each PCB storage (submitted with the notification form) facility owned or operated by genera- which demonstrates extraordinary rea- tors of PCB waste. Upon receiving sons why the information should be en- these notifications, EPA will assign titled to confidential treatment. generators unique EPA identification (b) Generators (other than those gen- numbers for each storage facility noti- erators exempt from notification under fying EPA under this section. paragraph (c)(1) of this section), com- (d) Persons required to notify under mercial storers, transporters, and dis- this section shall file EPA Form 7710–53 posers of PCB waste who have pre- with EPA by mailing the form to the viously notified EPA or a State of haz- following address: Document Control ardous waste activities under RCRA Officer, Office of Resource Conserva- shall notify EPA of their PCB waste tion and Recovery (5305P), Environ- activities under this part by filing EPA mental Protection Agency, 1200 Penn- Form 7710–53 with EPA by no later sylvania Ave., NW., Washington, DC than April 4, 1990. The notification 20460–0001. shall include the EPA identification (e) The requirements under this sec- number previously issued by EPA or tion to notify EPA and obtain EPA the State and upon receipt of the noti- identification numbers shall in no case fication, EPA shall verify and author- excuse compliance by any person sub- ize the use of the previously issued ject to the 1-year limit on storage prior identification number for PCB waste to disposal under § 761.65(a). activities. (f) When a facility has previously no- (c)(1) Generators of PCB waste need tified EPA of its PCB waste handling not notify EPA and receive unique activities using EPA Form 7710-53 and EPA identification numbers under this those activities change, the facility section, unless their PCB waste activi- must resubmit EPA Form 7710-53 to re- ties are described in paragraph (c)(2) of flect those changes no later than 30 this section. Generators exempted from days from when a change is made. Ex- notifying EPA under this paragraph amples of when a PCB waste handler shall use the generic identification must renotify the Agency include, but number ‘‘40 CFR PART 761’’ on the are not limited to the following: the manifests, records, and reports which company changes location of the facil- they shall prepare under this subpart, ity; or the company had notified solely

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as engaging in a certain type of PCB generator State) supplies the manifest waste handling activity and now wish- and requires its use, then the generator es to engage in another PCB waste ac- must use that State’s manifest. tivity (e.g., previously only commer- (e) If both the consignment State and cially stored PCB waste and now wish- the generator State supply manifests es to transport PCB waste). and require their use, the generator must use the consignment State’s [54 FR 52752, Dec. 21, 1989, as amended at 58 FR 15809, Mar. 24, 1993; 58 FR 34205, June 23, manifest. 1993; 59 FR 33697, June 30, 1994; 63 FR 35461, (f) If neither the generator State nor June 29, 1998; 72 FR 57241, Oct. 9, 2007; 74 FR the consignment State supplies the 30234, June 25, 2009] manifest, the generator may obtain the manifest from any source. § 761.207 The manifest—general re- (g) A generator shall designate on the quirements. manifest one off-site commercial stor- (a) A generator who relinquishes con- age or disposal facility approved under trol over PCB wastes by transporting, this part for the commercial storage or or offering for transport by his own ve- disposal of the PCBs and PCB Items de- hicle or by a vehicle owned by another scribed on the manifest. person, PCB waste for commercial off- (h) If the transporter is unable to de- site storage or off-site disposal shall liver the PCB waste to the designated prepare a manifest on EPA Form 8700– disposer or commercial storer, the 22, and if necessary, a continuation transporter must contact the generator sheet. The generator shall specify: of the PCB waste for instructions. The (1) For each bulk load of PCBs, the generator shall either designate an- identity of the PCB waste, the earliest other approved disposer or commercial date of removal from service for dis- storer, or instruct the transporter to posal, and the weight in kilograms of return the PCB waste back to the gen- the PCB waste. erator. (2) For each PCB Article Container or (i) The manifest which accompanies PCB Container, the unique identifying the PCB waste shall consist of at a number, type of PCB waste (e.g., soil, minimum the number of copies re- debris, small capacitors), earliest date quired to provide the generator, the of removal from service for disposal, initial transporter, each subsequent and weight in kilograms of the PCB transporter, and the owner or operator waste contained. of the designated commercial storage (3) For each PCB Article not in a or disposal facility with one legible PCB Container or PCB Article Con- copy each for their records, and one ad- tainer, the serial number if available, ditional copy to be returned to the gen- or other identification if there is no se- erator by the owner or operator of the rial number, the date of removal from first designated commercial storage or service for disposal, and weight in kilo- disposal facility. grams of the PCB waste in each PCB (j) The requirements of this section Article. apply only to PCB wastes as defined in (b) EPA does not maintain supplies of § 761.3. This includes PCB wastes with printed copies of Form 8700–22 for pub- PCB concentrations below 50 ppm lic use, although printed copies of the where the PCB concentration below 50 manifest may be available from State ppm was the result of dilution; these offices. Camera-ready copies of the PCB wastes are required under § 761.1(b) form are available for printing pur- to be managed as if they contained poses from State offices, EPA Regional PCB concentrations of 50 ppm and Offices, and EPA Headquarters. above. An example of such a PCB waste (c) If the State to which the ship- is spill cleanup material containing <50 ment is manifested (i.e., consignment ppm PCBs when the spill involved ma- State) supplies the manifest and re- terial containing PCBs at a concentra- quires its use, then the generator must tion of ≥50 ppm. However, there is no use that manifest. manifest requirement for material cur- (d) If the consignment State does not rently below 50 ppm which derives from supply the manifest, but the State in pre-April 18, 1978, spills of any con- which the generator is located (i.e., centration, pre-July 2, 1979, spills of <

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500 ppm PCBs, or materials decontami- by some other agreed-upon means, the nated in accordance with § 761.79. disposer or commercial storer to determine whether the PCB waste has actu- [54 FR 52752, Dec. 21, 1989, as amended at 63 FR 35461, June 29, 1998] ally been received. If the PCB waste has not been received, the generator § 761.208 Use of the manifest. shall contact the independent trans- (a)(1) The generator of PCB waste porter to determine the disposition of shall: the PCB waste. If the generator has not (i) Sign the manifest certification by received a hand-signed manifest from hand. an EPA-approved facility within 10 (ii) Obtain the handwritten signature days from the date of the telephone of the initial transporter and date of call or other agreed upon means of acceptance on the manifest. communication, to the independent (iii) Retain one copy among its transporter, the generator shall submit records in accordance with § 761.209(a). an exception report to the EPA Re- (iv) Give to the transporter the regional Administrator for the Region in maining copies of the manifest that which the generator is located, as spec- will accompany the shipment of PCB ified in § 761.215. The generator shall re- waste. tain a written record of all telephone (2) For bulk shipments of PCB waste or other confirmations to be included within the United States transported in the annual document log, in accord- solely by water, the generator shall ance with § 761.180. send three copies of the manifest dated (b)(1) A transporter shall not accept and signed in accordance with this sec- PCB waste from a generator unless it is tion directly to the owner or operator accompanied by a manifest signed by of the designated commercial storage the generator in accordance with para- or disposal facility. Copies of the mani- graph (a)(1) of this section, except that fest are not required for each trans- a manifest is not required if any one of porter. the following conditions exists: (3) For rail shipments of PCB waste (i) The shipment of PCB waste con- within the United States which origi- sists solely of PCB wastes with PCB nate at the site of generation, the gen- concentrations below 50 ppm, unless erator shall send at least three copies the PCB concentration below 50 ppm of the manifest dated and signed in ac- was the result of dilution, in which cordance with this section to: case § 761.1(b) requires that the waste (i) The next non-rail transporter, if be managed as if it contained PCBs at any. the concentration prior to dilution. (ii) The designated commercial stor- (ii) The PCB waste is accepted by the age or disposal facility if transported transporter for transport only to a solely by rail. storage or disposal facility owned or (4) When a generator has employed operated by the generator of the PCB an independent transporter to trans- waste. port the PCB waste to a commercial (2) Before transporting the PCB storer or disposer, the generator shall waste, the transporter shall sign and confirm by telephone, or by other date the manifest acknowledging ac- means of confirmation agreed to by ceptance of the PCB waste from the both parties, that the commercial stor- generator. The transporter shall return er or disposer actually received the a signed copy to the generator before manifested waste. The generator shall leaving the generator’s facility. confirm receipt of the waste by close of (3) The transporter shall ensure that business the day after he receives the the manifest accompanies the PCB manifest hand-signed by the commer- waste. cial storer or disposer, in accordance (4) A transporter who delivers PCB with paragraph (c)(1)(iv) of this sec- waste to another transporter, or to the tion. If the generator has not received designated commercial storer or dis- the hand-signed manifest within 35 poser of PCB waste, shall: days after the independent transporter (i) Obtain the date of delivery and accepted the PCB waste, the generator the handwritten signature of the subse- shall telephone, or communicate with quent transporter of PCB waste, or of

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the owner or operator of the designated (i) The designated commercial stor- commercial storage or disposal facility age or disposal facility listed on the on the manifest. manifest. (ii) Retain one copy of the manifest (ii) The next designated transporter in accordance with § 761.209(b). of PCB waste. (iii) Give the remaining copies of the (8) If the PCB waste cannot be deliv- manifest to the accepting transporter ered in accordance with paragraph of PCB waste, or to the designated (b)(7) of this section, the transporter commercial storage or disposal facil- shall contact the generator for further ity. directions and shall revise the manifest (5) The requirements of paragraphs and/or return the PCB waste according (b) (3) and (4) of this section shall not to the generator’s instructions. apply to transporters of bulk ship- (9) No provision of this section shall ments by water if all of the following be construed to affect or limit the ap- conditions are met: plicability of any requirement applica- (i) The PCB waste is delivered by ble to transporters of PCB waste under water (bulk shipment) to the des- regulations issued by the Department ignated commercial storage or disposal of Transportation (DOT) and set forth facility. at 49 CFR part 171. (ii) A shipping paper containing all (c)(1) If a commercial storage or dis- the information required on the mani- posal facility receives an off-site ship- fest (excluding EPA identification ment of PCB waste accompanied by a number, generator certification, and manifest, the owner or operator, or his signatures) accompanies the PCB agent, shall: waste. (i) Sign and date each copy of the (iii) The transporter delivering the manifest to certify that the PCB waste PCB waste obtains the date of delivery covered by the manifest was received. and handwritten signature of the (ii) Note any significant discrep- owner or operator of the designated ancies in the manifest (as defined in commercial storage or disposal facility § 761.210(a)(1)) on each copy of the mani- on either the manifest or the shipping fest. paper. (iii) Immediately give the trans- (iv) The person delivering the PCB porter at least one copy of the signed waste to the initial water (bulk ship- manifest. ment) transporter obtains the date of (iv) Within 30 days after the delivery, delivery and signature of the water send a copy of the manifest to the gen- (bulk shipment) transporter on the erator. manifest and forwards it to the des- (v) Retain a copy of each manifest ignated facility. among the facility’s records in accord- (v) A copy of the shipping paper or ance with § 761.209(d). manifest is retained by each water (2) If a commercial storage or dis- (bulk shipment) transporter in accord- posal facility receives PCB waste from ance with § 761.209(b). a rail or water (bulk shipment) trans- (6) For shipments involving rail porter accompanied by a shipping transportation, the requirements of paper containing all the information paragraphs (b)(3) and (b)(4) of this sec- required on the manifest except the tion shall not apply. Instead, the re- EPA identification numbers, genera- quirements described at § 263.20(f) of tor’s certification, and signatures, the this chapter for the rail transportation owner or operator, or his agent, shall: of hazardous waste apply to such ship- (i) Sign and date each copy of the ments. The rail transporter shall re- manifest or shipping paper to certify tain one copy of the manifest or rail that the PCB waste covered by the shipping paper in accordance with manifest or shipping paper was re- § 761.209(b). ceived. (7) The transporter shall deliver the (ii) Note any significant discrep- entire quantity of PCB waste accepted ancies in the manifest or shipping from a generator or transporter to ei- paper on each copy of the manifest or ther of the following destinations: shipping paper.

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(iii) Immediately give the rail or 3 years from the date the PCB waste water transporter at least one copy of was accepted by the initial transporter. the manifest or shipping paper, if ap- (3) For shipments of PCB waste by plicable. rail within the United States: (iv) Within 30 days after the delivery, (i) The initial rail transporter shall send a copy of the signed and dated keep a copy of the manifest and the manifest to the generator; however, if shipping paper required to accompany the manifest has not been received the PCB waste for a period of at least within 30 days after delivery, the owner 3 years from the date the PCB waste or operator shall send a copy of the was accepted by the initial transporter. shipping paper signed and dated to the (ii) The final rail transporter shall generator. keep a copy of the signed manifest, or (v) Retain at the commercial storage the required shipping paper if signed by or disposal facility a copy of the mani- the designated facility in lieu of the fest and shipping paper, if signed in manifest, for a period of at least 3 lieu of the manifest, in accordance years from the date the PCB waste was with § 761.209(d). accepted by the initial transporter. (3) Whenever an off-site shipment of (c) The owner or operator of a PCB PCB waste is initiated from a commer- commercial storage or disposal facility cial storage or disposal facility, the that receives off-site shipments of PCB owner or operator of the commercial waste shall retain at the facility for at storage or disposal facility shall com- least 3 years a copy of each manifest or ply with the manifest requirements shipping paper that the owner or oper- that apply to generators of PCB waste. ator signs in accordance with § 761.208 (c)(1) or (c)(3). § 761.209 Retention of manifest (d) The periods of record retention re- records. quired by this section shall be extended (a) A generator of PCB waste shall automatically during the course of any keep a copy of each manifest signed in outstanding enforcement action re- accordance with § 761.208(a)(1) until the garding the regulated activity. generator receives a signed copy from [54 FR 52752, Dec. 21, 1989, as amended at 58 the designated commercial storage or FR 34205, June 23, 1993] disposal facility which received the PCB waste. The copy signed by the § 761.210 Manifest discrepancies. commercial storer or disposer shall be (a) Manifest discrepancies are dif- retained for at least 3 years from the ferences between the quantity or type date the PCB waste was accepted by of PCB waste designated on the mani- the initial transporter. A generator fest or shipping paper and the quantity subject to annual document require- or type of PCB waste actually delivered ments under § 761.180 shall retain copies to and received by a designated facil- of each manifest for the period re- ity. quired by § 761.180(a). (1) Significant discrepancies in quan- (b)(1) A transporter of PCB waste tity are: shall keep a copy of the manifest (i) Variations greater than 10 percent signed by the generator, transporter, in weight of PCB waste in containers. and the next designated transporter, if (ii) Any variation in piece count, applicable, or the owner or operator of such as a discrepancy of one PCB the designated commercial storage or Transformer or PCB Container or PCB disposal facility. This copy shall be re- Article Container in a truckload. tained for a period of at least 3 years (2) Significant discrepancies in type from the date the PCB waste was ac- of PCB waste are obvious differences cepted by the initial transporter. which may be discovered by inspection (2) For shipments of PCB waste deliv- or waste analysis, such as the substi- ered to the designated commercial tution of solids for liquids or the sub- storage or disposal facility by water stitution of high concentration PCBs (bulk shipment), each water (bulk ship- (above 500 ppm) with lower concentra- ment) transporter shall retain a copy tion materials. of the shipping paper described in (b) Upon discovering a significant § 761.208(b)(5)(ii) for a period of at least discrepancy, the owner or operator of

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the designated commercial storage or (1) The EPA identification number, disposal facility shall attempt to rec- name, and address of the PCB commer- oncile the discrepancy with the waste cial storage or disposal facility. generator or transporter. If the dis- (2) The date the commercial storage crepancy is not resolved within 15 days or disposal facility received the after receiving the PCB waste, such unmanifested PCB waste. owner or operator shall immediately (3) The EPA identification number, submit to the Regional Administrator name, and address of the generator and for the Region in which the designated transporter, if available. facility is located a letter describing (4) A description of the type and the discrepancy and attempts to rec- quantity of the unmanifested PCB oncile it, and a copy of the manifest or waste received at the facility. (5) A brief explanation of why the shipping paper at issue. waste was unmanifested, if known. [54 FR 52752, Dec. 21, 1989, as amended at 58 (6) The disposition made of the FR 34205, June 23, 1993] unmanifested waste by the commercial storage or disposal facility, including: § 761.211 Unmanifested waste report. (i) If the waste was stored or disposed (a) After April 4, 1990, if a PCB com- by that facility, was the generator mercial storage or disposal facility re- identified and was a manifest subse- ceives any shipment of PCB waste from quently supplied. an off-site source without an accom- (ii) If the waste was sent back to the panying manifest or shipping paper generator, why and when. (where required in place of a manifest), [54 FR 52752, Dec. 21, 1989, as amended at 58 and any part of the shipment consists FR 34205, June 23, 1993] of any PCB waste regulated for disposal, then the owner or operator of § 761.215 Exception reporting. the commercial storage or disposal fa- (a) A generator of PCB waste, who cility shall attempt to contact the gen- does not receive a copy of the manifest erator, using information supplied by with the handwritten signature of the the transporter, to obtain a manifest owner or operator of the designated or to return the PCB waste. PCB commercial storage or disposal fa- (b) If the owner or operator of the cility within 35 days of the date the commercial storage or disposal facility waste was accepted by the initial cannot contact the generator of the transporter, shall immediately contact PCB waste, he shall notify the Re- the transporter and/or the owner or op- gional Administrator of the EPA re- erator of the designated facility to de- gion in which his facility is located of termine the status of the PCB waste. (b) A generator of PCB waste subject the unmanifested PCB waste so that to the manifesting requirements shall the Regional Administrator can deter- submit an Exception Report to the mine whether further actions are re- EPA Regional Administrator for the quired before the owner or operator Region in which the generator is lo- may store or dispose of the cated if the generator has not received unmanifested PCB waste. a copy of the manifest with the hand (c) Within 15 days after receiving the written signature of the owner or oper- unmanifested PCB waste, the owner or ator of the designated facility within 45 operator shall prepare and submit a re- days of the date the waste was accept- port to the Regional Administrator for ed by the initial transporter. The ex- the Region in which the commercial ception report shall be submitted to storage or disposal facility is located EPA no later than 45 days from the and to the Regional Administrator for date on which the generator should the Region in which the PCB waste have received the manifest. The Excep- originated, if known. The report may tion Report shall include the following: be submitted on EPA Form 8700–13B, or (1) A legible copy of the manifest for by a written letter designated which the generator does not have con- ‘‘Unmanifested Waste Report.’’ The re- firmation of delivery. port shall include the following infor- (2) A cover letter signed by the gener- mation: ator or his authorized representative

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explaining the efforts taken to locate (2) A cover letter signed by the sub- the PCB waste and the results of those mitter or an authorized representative efforts. explaining: (c) A disposer of PCB waste shall sub- (i) The date(s) when the PCBs or PCB mit a One-year Exception Report to Items were removed from service for the EPA Regional Administrator for disposal. the Region in which the disposal facil- (ii) The date(s) when the PCBs or ity is located no later than 45 days PCB Items were received by the sub- from the end of the 1-year storage for mitter of the report, if applicable. disposal date when the following oc- (iii) The date(s) when the affected curs: PCBs or PCB Items were transferred to (1) The disposal facility receives a designated disposal facility. PCBs or PCB Items on a date more (iv) The identity of the transporters, than 9 months from the date the PCBs commercial storers, or disposers known or PCB Items were removed from serv- to be involved with the transaction. ice for disposal, as indicated on the (v) The reason, if known, for the manifest or continuation sheet; and delay in bringing about the disposal of (2) Because of contractual commit- the affected PCBs or PCB Items within ments or other factors affecting the fa- 1 year from the date of removal from cility’s disposal capacity, the disposer service for disposal. of PCB waste could not dispose of the (f) PCB/radioactive waste that is ex- affected PCBs or PCB Items within 1 empt from the 1-year storage for dis- year of the date of removal from serv- posal time limit pursuant to ice for disposal. § 761.65(a)(1) is also exempt from the ex- (d) A generator or commercial storer ception reporting requirements of para- of PCB waste who manifests PCBs or graphs (c), (d), and (e) of this section. PCB Items to a disposer of PCB waste [54 FR 52752, Dec. 21, 1989, as amended at 55 shall submit a One-year Exception Re- FR 26205, June 27, 1990; 58 FR 34205, June 23, port to the EPA Regional Adminis- 1993; 63 FR 35461, June 29, 1998] trator for the Region in which the generator or commercial storer is located § 761.218 Certificate of disposal. no later than 45 days from the date the (a) For each shipment of manifested following occurs: PCB waste that the owner or operator (1) The generator or commercial stor- of a disposal facility accepts by signing er transferred the PCBs or PCB Items the manifest, the owner or operator of to the disposer of PCB waste on a date the disposal facility shall prepare a within 9 months from the date of re- Certificate of Disposal for the PCBs moval from service for disposal of the and PCB Items disposed of at the facil- affected PCBs or PCB Items, as indi- ity, which shall include: cated on the manifest or continuation (1) The identity of the disposal facil- sheet; and ity, by name, address, and EPA identi- (2) The generator or commercial stor- fication number. er either has not received within 13 (2) The identity of the PCB waste af- months from the date of removal from fected by the Certificate of Disposal inservice for disposal a Certificate of Dis- cluding reference to the manifest num- posal confirming the disposal of the af- ber for the shipment. fected PCBs or PCB Items, or the gen- (3) A statement certifying the fact of erator or commercial storer receives a disposal of the identified PCB waste, Certificate of Disposal confirming dis- including the date(s) of disposal, and posal of the affected PCBs or PCB identifying the disposal process used. Items on a date more than 1 year after (4) A certification as defined in the date of removal from service. § 761.3. (e) The One-year Exception Report (b) The owner or operator of the dis- shall include: posal facility shall send the Certificate (1) A legible copy of any manifest or of Disposal to the generator identified other written communication relevant on the manifest which accompanied the to the transfer and disposal of the af- shipment of PCB waste within 30 days fected PCBs or PCB Items. of the date that disposal of each item

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of PCB waste identified on the mani- § 761.243 Standard wipe sample meth- fest was completed unless the gener- od and size. ator and the disposer contractually (a) Collect a surface sample from a agree to another time frame. natural gas pipe segment or pipeline (c) The disposal facility shall keep a section using a standard wipe test as copy of each Certificate of Disposal defined in § 761.123. Detailed guidance among the records that it retains for the entire wipe sampling process under § 761.180(b). appears in the document entitled, (d)(1) Generators of PCB waste shall ‘‘Wipe Sampling and Double Wash/ keep a copy of each Certificate of Dis- Rinse Cleanup as Recommended by the posal that they receive from disposers Environmental Protection Agency PCB of PCB waste among the records they Spill Cleanup Policy,’’ dated June 23, retain under § 761.180(a). 1987 and revised on April 18, 1991. This (2) Commercial storers of PCB waste document is available on EPA’s Web shall keep a copy of each Certificate of site at http://www.epa.gov/pcb, or from Disposal that they receive from dis- the Program Management, Commu- posers of PCB waste among the records nications, and Analysis Office, Office of they retain under § 761.180(b). Resource Conservation and Recovery (5305P), Environmental Protection [54 FR 52752, Dec. 21, 1984, as amended at 63 Agency, 1200 Pennsylvania Ave., NW., FR 35462, June 29, 1998] Washington, DC 20460–0001. (b) Collect a surface sample from a Subpart L [Reserved] minimum surface area of 100 cm2 at each sampling site selected. The EPA Subpart M—Determining a PCB Regional Administrator may approve, in writing, requests to collect a sample Concentration for Purposes of from smaller surface areas, when <100 Abandonment or Disposal of cm2 of surface eligible for sampling is Natural Gas Pipeline: Select- present; e.g., when sampling a small di- ing Sample Sites, Collecting ameter pipe, a small valve, or a small Surface Samples, and Ana- regulator. When smaller surfaces are lyzing Standard PCB Wipe sampled, convert the measurement to Samples the equivalent measurement for 100 cm2 for purposes of comparison to standards based on 100 cm2. SOURCE: 63 FR 35462, June 29, 1998, unless otherwise noted. [63 FR 35462, June 29, 1998, as amended at 72 FR 57241, Oct. 9, 2007; 74 FR 30235, June 25, § 761.240 Scope and definitions. 2009] (a) Use these procedures to select § 761.247 Sample site selection for pipe surface sampling sites for natural gas segment removal. pipe to determine its PCB surface con- (a) General. (1) Select the pipe seg- centration for abandonment-in-place or ments to be sampled by following the removal and disposal off-site in accord- directions in paragraph (b) of this sec- ance with § 761.60(b)(5). tion. (b) ‘‘Pipe segment’’ means a length of (2) Locate the proper position along natural gas pipe that has been removed the length of the pipe segment that from the pipeline system to be disposed you have selected for sampling, by fol- of or reused, and that is usually ap- lowing the directions in paragraph (c) proximately 12.2 meters (40 feet) or of this section. shorter in length. Pipe segments are (3) Select the proper sampling posi- usually linear. tion around the circumference of the (c) ‘‘Pipeline section’’ means a length pipe segment that you have selected of natural gas pipe that has been cut or for sampling, by following the direc- otherwise separated from the active tions in paragraph (d) of this section. pipeline, usually for purposes of aban- (4) Prior to removing pipe from the donment, and that is usually longer ground or lifting the pipe from its loca- than 12.2 meters in length. Pipeline tion during former operations, mark sections may be branched. the top side of the pipe.

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(5) Do not sample if there are free- the first pipe segment has the number flowing liquids in the pipe segment. 1, add 64 to 1 to select segment 65. Free-flowing liquids must be removed Next, add 64 to 65 to select segment 129. prior to sampling. Continue in this fashion to select all (b) Selecting pipe segments to sample. seven segments: 1, 65, 129, 193, 257, 321, Select the pipe segment(s) that you and 383. will sample from a length of pipe or (iii) When removing a length of pipe group of pipe segments, as follows: having multiple contiguous segments (1) Do not sample a pipe segment more than 3 miles in total length for that is longer than 12.2 meters (40 feet). purposes of disposal, take samples of If a segment is longer than 12.2 meters each segment that is 1⁄2 mile distant in length, cut the segment so that all from the segment previously sampled. resulting segments are 12.2 meters or Sample a minimum of seven segments. less in length. (c) Selecting the sampling position— (2) Determine which pipe segments to length. Select the sampling position sample as follows: along the length of the pipe segment, (i) When a length of pipe having as follows: seven or fewer segments is removed for (1) Take samples at the end upstream purposes of disposal, sample each pipe of the former gas flow of each segment segment. removed. (ii) When removing a length of pipe (2) If the pipe segment is cut with a having multiple contiguous segments torch or other high temperature heat less than 3 miles in total length, take source, take the sample at least 15 cm samples from a total of seven seg- (6 inches) inside the cut end of the pipe ments. segment. (A) Sample the first and last seg- (3) If the pipe segment is cut with a ments removed. saw or other mechanical device, take (B) Select the five additional seg- the sample at least 2 cm (1 inch) inside ments according to one of the two fol- the end of the pipe segment. lowing procedures: (4) If the sample site location se- (1) Assign all segments a unique selected in the procedure at paragraph quential number. Then select five num- (c)(2) or (c)(3) of this section is a porous bers using a random number table or surface (for example, there is signifi- random number generator. If the ran- cant corrosion so that the wipe mate- dom number generator or random num- rial will be shredded), then move the ber table produces either the first pipe sample site further inside the pipe seg- segment, the last pipe segment, or any ment (away from the end of the pipe or previously selected segment, select an- pipe segment) until there is no such po- other random number until there are rous surface. For purposes of this sub- seven different numbers, each cor- part, natural gas pipe with a thin po- responding to a different pipe segment. rous corrosion preventive coating is a (2) Divide the total number of seg- non-porous surface. ments by six. Round the resulting (5) If there is not a non-porous sur- quotient off to the nearest whole num- face accessible by paragraphs (c)(2) and ber. The resulting number is the inter- (c)(3) of this section, use one of the fol- val between the segments you will lowing three options: sample. For example, cut a 2.9 mile (i) Sample the downstream end of the length of pipeline into 383 segments of pipe segment using the same sample approximately 40 feet each. Sample the site location procedure as for the up- first (number 1) and last (number 383) stream end. segments. To determine which addi- (ii) Select another pipe segment tional five segments to sample, divide using the random selection procedure the total number of segments, 383, by 6. described in paragraph (b) of this sec- Round up the resulting number in this tion. example, 63.8, to the next whole num- (iii) If there is no other pipe segment ber, 64. Add 64 to the number of each in the population to be sampled and preceding pipe segment five separate both ends of a pipe segment have po- times to select five additional pipe seg- rous surfaces at all possible sample col- ments for sampling. In this example, lection sites, then assume that the pipe

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segment contains ≥50 ppm PCB but <500 smaller sections to be a separate aban- ppm PCB. donment and sample each one, at a (d) Selecting the sample position—cir- minimum, at all ends. cumference. Based on the mark on the (3) Use the following procedure to lo- top of the pipe segment made prior to cate representative sample collection removing pipe from the ground or lift- sites in pipeline sections at points ing the pipe from its location during other than the suction and pressure former operations, sample the inside side of compressor stations, or the ends center of the bottom of the pipe being of the pipeline section to be abandoned. sampled. Make sure the sample is cen- (i) First, assign a unique identifying tered on the bottom of the pipe seg- sequential number to each kilometer ment; that is, sample an equal area on or fraction of a kilometer length of both sides of the middle of the bottom pipe within the entire pipeline section. of the pipe segment for the entire (ii) Use a random number table or a length of the sample. random number generator to select each representative sample collection [63 FR 35462, June 29, 1998, as amended at 64 FR 33762, June 24, 1999] site from a complete list of the sequential identification numbers. § 761.250 Sample site selection for (iii) Samples may be collected by re- pipeline section abandonment. moving any covering soil, cutting the This procedure is for the sample site pipe to gain access to the sampling lo- selection for a pipeline section to be cation, and collecting the surface sam- abandoned, in accordance with ple with the pipe in place, rather than § 761.60(b)(5)(i)(B). completely removing the pipeline sec- (a) General. (1) Select sample collections to collect the surface sample. tion sites in the pipeline section(s) by [63 FR 35462, June 29, 1998, as amended at 64 following the directions in paragraph FR 33762, June 24, 1999] (b) of this section. (2) Select the proper sampling posi- § 761.253 Chemical analysis. tion along the pipe by following the di- (a) Extract PCBs from the standard rections in § 761.247 (c) and (d). wipe sample collection medium and (3) Assure, by visual inspection, the clean-up the extracted PCBs in accord- absence of free-flowing liquids in the ance with either Method 3500B/3540C or pipe by affirming no liquids at all liq- Method 3500B/3550B from EPA’s SW-846, uid collection points and all ends of the Test Methods for Evaluating Solid pipeline section to be abandoned. Waste, or a method validated under (b) Selection sample collection sites. At subpart Q of this part. Use Method 8082 a minimum, sample all ends of all pipe- from SW-846, or a method validated line sections to be abandoned in place. under subpart Q of this part, to analyze (1) If the pipeline section to be aban- these extracts for PCBs. doned is between the pressure side of (b) Report all PCB sample concentra- one compressor station and the suction tions in μg/100 cm2 (16 square inches) of side of the next compressor station surface sampled. If sampling an area downstream of the former gas flow, at smaller than 100 cm2, report converted a minimum, sample all ends of the sample concentrations in accordance abandoned pipe. with § 761.243(b). (2) If the pipeline section to be abandoned is longer than the distance be- § 761.257 Determining the regulatory tween the pressure side of one com- status of sampled pipe. pressor station and the suction side of (a) For purposes of removal for dis- the next compressor station down- posal of a pipe segment that has been stream of the former gas flow, divide sampled, the sample results for that the pipeline section, for purposes of segment determines its PCB surface sampling, into smaller pipeline sec- concentration. Determine the PCB sur- tions no longer than the distance from face concentration of a segment which the pressure side of one compressor was not sampled as follows: station to the suction side of the next (1) If the unsampled pipe segment is compressor station downstream of the between two pipe segments which have former gas flow. Consider each of the been sampled, assume that the

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unsampled segment has the same PCB that is not in a container and porous surface concentration as the nearest surfaces. sampled pipe segment. (b) Use the following procedures to (2) If an unsampled pipe segment is sample bulk PCB remediation waste equidistant between two pipe segments that is in a single container. which have been sampled, assume the (1) Use a core sampler to collect a PCB surface concentration of the minimum of one core sample for the unsampled segment to be the arith- entire depth of the waste at the center metic mean of the PCB surface con- of the container. Collect a minimum of centrations measured in the two equi- 50 cm3 of waste for analysis. distant, sampled, pipe segments. (2) If more than one core sample is (b) For purposes of abandonment of a taken, thoroughly mix all samples into pipeline section, assume that the PCB a composite sample. Take a subsample surface concentration for an entire of a minimum of 50 cm3 from the mixed pipeline section is the arithmetic mean composite for analysis. of the PCB surface concentrations (c) Use the following procedures to measured at the ends of the pipeline sample bulk PCB remediation waste section. If additional representative that is in more than one container. samples were taken in a pipeline sec- (1) Segregate the containers by type tion, assume that the PCB surface con- (for example, a 55-gallon drum and a centration for the entire pipeline sec- roll-off container are types of con- tion is the arithmetic mean of the containers). centrations measured in all representa- (2) For fewer than three containers of tive samples taken. the same type, sample all containers. (c) For purposes of removal for dis- (3) For more than three containers of posal under § 761.60(b)(5)(ii)(A)(1) or the same type, list the containers and abandonment under § 761.60(b)(5)(i)(B), assign each container an unique se- if the surface PCB concentration of a quential number. Use a random number pipe segment, determined by direct generator or table to select a minimum measurement or in accordance with of 10 percent of the containers from the paragraph (a) of this section, or of a list, or select three containers, which- pipeline section as determined in ac- ever is the larger. cordance with paragraph (b) of this sec- (4) Sample the selected container(s) tion, is >10 μg/100 cm2, but <100 μg/100 according to paragraph (b) of this sec- cm2, then that segment or section is tion. PCB-Contaminated. § 761.267 Sampling non-porous sur- Subpart N—Cleanup Site Charac- faces. terization Sampling for PCB (a) Sample large, nearly flat, non-po- Remediation Waste in Ac- rous surfaces by dividing the surface cordance with § 761.61(a)(2) into roughly square portions approximately 2 meters on each side. Follow SOURCE: 63 FR 35464, June 29, 1998, unless the procedures in § 761.302(a). otherwise noted. (b) It is not necessary to sample small or irregularly shaped surfaces. § 761.260 Applicability. This subpart provides a method for § 761.269 Sampling liquid PCB remedi- collecting new data for characterizing ation waste. a PCB remediation waste cleanup site (a) If the liquid is single phase, col- or for assessing the sufficiency of exist- lect and analyze one sample. There are ing site characterization data, as re- no required procedures for collecting a quired by § 761.61(a)(2). sample. (b) If the liquid is multi-phasic, sepa- § 761.265 Sampling bulk PCB remedi- rate the phases, and collect and ana- ation waste and porous surfaces. lyze a sample from each liquid phase. (a) Use a grid interval of 3 meters and There are no required procedures for the procedures in §§ 761.283 and 761.286 collecting a sample from each single to sample bulk PCB remediation waste phase liquid.

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(c) If the liquid has a non-liquid Confirmation of compliance with the phase which is >0.5 percent by total cleanup levels in § 761.61(a)(4) is only weight of the waste, separate the non- verifiable for the area sampled in ac- liquid phase from the liquid phase and cordance with this subpart. Do not sample it separately as a non-liquid in make conclusions or extrapolations accordance with § 761.265. about PCB concentrations outside of the area which has been cleaned up and § 761.272 Chemical extraction and verified based on the results of this analysis of samples. verification sampling. Use either Method 3500B/3540C or Method 3500B/3550B from EPA’s SW-846, § 761.283 Determination of the number Test Methods for Evaluating Solid of samples to collect and sample Waste, or a method validated under collection locations. subpart Q of this part, for chemical ex- This section addresses how to deter- traction of PCBs from individual and mine the number of samples to collect composite samples of PCB remediation and sample collection locations for waste. Use Method 8082 from SW-846, or bulk PCB remediation waste and po- a method validated under subpart Q of this part, to analyze these extracts for rous surfaces destined to remain at a PCBs. cleanup site after cleanup. (a) Minimum number of samples. (1) At § 761.274 Reporting PCB concentra- each separate cleanup site at a PCB re- tions in samples. mediation waste location, take a min- (a) Report all sample concentrations imum of three samples for each type of for non-liquid PCBs on a dry weight bulk PCB remediation waste or porous basis as micrograms of PCBs per gram surface at the cleanup site, regardless of sample (ppm by weight). Report sur- of the amount of each type of waste face sampling results as μg/100 cm2. Di- that is present. There is no upper limit vide 100 cm2 by the surface area and to the number of samples required or multiply this quotient by the total allowed. number of micrograms of PCBs on the (2) This is an example of how to cal- surface to obtain the equivalent meas- culate the minimum number of re- urement of micrograms per 100 cm2. quired samples at a PCB remediation (b) Report all sample concentrations waste location. There are three dis- for liquid PCBs on a wet weight basis tinct cleanup sites at this example lo- as micrograms of PCBs per gram of cation: a loading dock, a transformer sample (ppm by weight). storage lot, and a disposal pit. The minimum number of samples to take Subpart O—Sampling To Verify appears in parentheses after each type Completion of Self-Imple- of waste for each cleanup site. The PCB menting Cleanup and On-Site remediation wastes present at the load- Disposal of Bulk PCB Remedi- ing dock are concrete (three samples) ation Waste and Porous Sur- and clay soil (three samples). The non- faces in Accordance With liquid PCB remediation wastes present § 761.61(a)(6) at the transformer storage lot are oily soil (three samples), clay soil (three samples) and gravel (three samples). SOURCE: 63 FR 35465, June 29, 1998, unless otherwise noted. The PCB remediation wastes present at the disposal pit are sandy soil (three § 761.280 Application and scope. samples), clay soil (three samples), oily Follow the procedures in this subpart soil (three samples), industrial sludge when sampling to verify completion of (three samples), and gravel (three sam- the cleanup for self-implementing, on- ples). site disposal of bulk PCB remediation (b) Selection of sample locations—gen- waste and porous surfaces consistent eral. (1)(i) Use a square-based grid sys- with the levels of § 761.61(a)(4)(i) and tem to overlay the entire area to be (iii). The objective of this subpart is sampled. Orient the grid axes on a not to search for new contamination. magnetic north-south line centered in

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the area and an east-west axis perpen- in centimeters (or inches) the max- dicular to the magnetic north-south imum magnetic east-west dimension of axis also centered in the area. the area to be sampled. Designate the (ii) If the site is recleaned based on north-south and east-west dimensions the results of cleanup verification con- (describing the west and south bound- ducted in accordance with § 761.61(a)(6), aries, respectively, of the area to be follow the procedures in paragraph (b) sampled), as the reference axes of a of this section for locating sampling square-based grid system. points after the recleaning, but reori- (ii) Use a random number table or ent the grid axes established in para- random number generator to select a graph (b)(1)(i) of this section by moving pair of coordinates that will locate the the origin one meter in the direction of sample within the area to be sampled. magnetic north and one meter in the The first coordinate in the pair is the direction east of magnetic north. measurement on the north-south axis. (2) Mark out a series of sampling The second coordinate in the pair is points 1.5 meters apart oriented to the the measurement on the east-west axis. grid axes. The sampling points shall Collect the sample at the intersection proceed in every direction to the ex- of an east-west line drawn through the tent sufficient to result in a two-di- measured spot on the north-south axis, mensional grid completely overlaying and a north-south line drawn through the sampling area. the measured spot on the east-west (3) Collect a sample at each point if axis. If the cleanup site is irregularly the grid falls in the cleanup area. Ana- shaped and this intersection falls out- lyze all samples either individually or side the cleanup site, select a new pair according to the compositing schemes of sampling coordinates. Continue to provided in the procedures at § 761.289. select pairs of sampling coordinates So long as every sample collected at a until three are selected for each type of grid point is analyzed as either an indi- bulk PCB remediation waste or porous vidual sample or as part of a composite surface at the cleanup site. sample, there are no other restrictions (d) Area of inference. Analytical re- on how many samples are analyzed. sults for an individual sample point (c) Selection of sample locations—small cleanup sites. When a cleanup site is apply to the sample point and to an sufficiently small or irregularly shaped area of inference extending to four that a square grid with a grid interval imaginary lines parallel to the grid of 1.5 meters will not result in a min- axes and one half grid interval distant imum of three sampling points for each from the sample point in four different type of bulk PCB remediation waste or directions. The area of inference forms porous surface at the cleanup site, a square around the sample point. The there are two options. sides of the square are parallel to the (1) Use a smaller square grid interval grid axes and one grid interval in and the procedures in paragraph (b) of length. The sample point is in the cen- this section. ter of the square area of inference. The (2) Use the following coordinate- area of inference from a composite based random sampling scheme. If the sample is the total of the areas of the site is recleaned based on the results of individual samples included in the cleanup verification conducted in ac- composite. cordance with § 761.61(a)(6), follow the procedures in this section for locating § 761.286 Sample size and procedure for collecting a sample. sampling points after the recleaning, but select three new pairs of sampling At each selected sampling location coordinates. for bulk PCB remediation waste or po- (i) Beginning in the southwest corner rous surfaces, collect at least 20 milli- (lower left when facing magnetic liters of waste, or a portion of suffi- north) of the area to be sampled, meas- cient weight for the chemical analyst ure in centimeters (or inches) the max- to measure the concentration of PCBs imum magnetic north-south dimension and still have sufficient analytical de- of the area to be sampled. Next, begin- tection sensitivity to reproducibly ning in the southwest corner, measure measure PCBs at the levels designated

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in § 761.61(a)(4). Use a core sampler hav- imum dimensions of the area enclosing ing a diameter ≥2 cm and ≤3 cm. Collect a nine grid point composite is two grid waste to a maximum depth of 7.5 cms. intervals bounded by three collinear grid points (3.0 meters or approxi- § 761.289 Compositing samples. mately 10 feet long). Take all samples Compositing is a method of com- in the composite at the same depth. bining several samples of a specific Assure that composite sample areas type of bulk PCB remediation waste or and individually analyzed samples porous surface from nearby locations completely overlay the cleanup site. for a single chemical analysis. There (ii) The second procedure is for a sin- are two procedures for compositing gle point source of contamination, such bulk PCB remediation waste samples. as discharge into a large containment These procedures are based on the area (e.g., pit, waste lagoon, or evapo- method for selecting sampling site lo- ration pond), or a leak onto soil from a cations in § 761.283(b) and (c). The single single drum or tank. Single point chemical analysis of a composite sam- source contamination may be from a ple results in an averaging of the con- one-time or continuous contamination. centrations of its component samples. Composites come from two stages: an The area of inference of a composite is initial compositing area centered in determined by the area of inference of the area to be sampled, and subsequent each of its component samples as de- compositing areas forming concentric scribed in § 761.283(d). Compositing is square zones around the initial not mandatory. However, if compositing area. The center of the compositing is used, it must be per- initial compositing area and each of formed in accordance with the fol- the subsequent compositing areas is lowing procedures. the origin of the grid axes. (a) Compositing in the field or in a lab- (A) Definition of the initial compositing oratory. Compositing may occur either area. The initial compositing area is in the field or in a laboratory. Prepare based on a square that contains nine composite samples using equal volumes grid points, is centered on the grid ori- of each constituent or component sam- gin, and has sides two grid intervals ple. Composited samples must be from long. The initial compositing area has the same type of bulk PCB remediation the same center as this square and waste or porous surface (see the exam- sides one half a grid interval more dis- ple at § 761.283(a)(2)). Mix composite tant from the center than the square. samples thoroughly. From each well- The initial compositing area has sides mixed composite sample, take a por- three grid intervals long. tion of sufficient weight for the chem- (B) Definition of subsequent ical analyst to measure the concentra- compositing areas. Subsequent com- tion of PCBs and still have sufficient posite sampling areas are in concentric analytical detection sensitivity to square zones one grid interval wide reproducibly measure PCBs at the lev- around the initial compositing area els designated in § 761.61(a)(4). and around each successive subsequent (b)(1) Compositing from samples col- compositing area. The inner boundary lected at grid points in accordance with of the first subsequent compositing § 761.283(b). There are two kinds of com- area is the outer boundary of the ini- posite sampling procedures depending tial compositing area. The outer on the original source of contamina- boundary of the first subsequent tion of the site. compositing area is centered on the (i) The first procedure is for sites grid origin, has sides one grid interval with multiple point sources of con- more distant from the grid origin than tamination (such as an old electrical the inner boundary, and is two grid in- equipment storage area, a scrap yard, tervals longer on a side than the inner or repair shop) or for unknown sources boundary. The inner boundary of each of contamination. Under this further subsequent compositing area is compositing scheme, composite a max- the outer boundary of the previous sub- imum of nine samples for each type of sequent compositing area. The outer bulk PCB remediation waste or porous boundary of each further subsequent surface at the cleanup site. The max- compositing area is centered on the

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grid origin, has sides one grid interval § 761.295 Reporting and recordkeeping more distant from the grid origin than of the PCB concentrations in sam- the inner boundary, and is two grid in- ples. tervals longer on a side than the inner (a) Report all sample concentrations boundary. for bulk PCB remediation waste and (C) Taking composite samples from the porous surfaces on a dry weight basis initial and subsequent compositing areas. and as micrograms of PCBs per gram of (1) Select composite sampling areas sample (ppm by weight). from the initial compositing area and (b) Record and keep on file for 3 years subsequent compositing areas such the PCB concentration for each sample that all grid points in the initial or composite sample. compositing area and subsequent compositing areas are part of a com- § 761.298 Decisions based on PCB con- posite or individual sample. centration measurements resulting (2) A person may include in a single from sampling. composite sample a maximum of all (a) For grid samples which are chemi- nine grid points in the initial cally analyzed individually, the PCB compositing area. The maximum num- concentration applies to the area of in- ber of grid points in a composite sam- ference as described in § 761.283(d). ple taken from a subsequent (b) For grid samples analyzed as part compositing area is eight. These eight of a composite sample, the PCB con- grid points must be adjacent to one an- centration applies to the area of infer- other in the subsequent compositing ence of the composite sample as de- area, but need not be collinear. scribed in § 761.283(d) (i.e., the area of (2) Compositing from samples taken at inference is the total of the areas of grid points or pairs of coordinates in ac- the individual samples included in the cordance with § 761.283(c). Samples col- composite). lected at small sites are based on se- (c) For coordinate pair samples ana- lecting pairs of coordinates or using lyzed as part of a composite sample, in the sample site selection procedure for accordance with §§ 761.283(c)(2) and grid sampling with a smaller grid in- 761.289(b)(2)(ii), the PCB concentration terval. applies to the entire cleanup site. (i) Samples collected from a grid having a smaller grid interval. Use the proce- Subpart P—Sampling Non-Porous dure in paragraph (b)(1)(i) of this sec- Surfaces for Measurement- tion to composite samples and deter- Based Use, Reuse, and On- mine the area of inference for composite samples. Site or Off-Site Disposal Under (ii) Samples collected from pairs of co- § 761.61(a)(6) and Decon- ordinates. All three samples must be tamination Under composited. The area of inference for § 761.79(b)(3) the composite is the entire area sampled. SOURCE: 63 FR 35467, June 29, 1998, unless otherwise noted. § 761.292 Chemical extraction and analysis of individual samples and § 761.300 Applicability. composite samples. This subpart provides sample site se- Use either Method 3500B/3540C or lection procedures for large, nearly flat Method 3500B/3550B from EPA’s SW-846, non-porous surfaces, and for small or Test Methods for Evaluating Solid irregularly shaped non-porous surfaces. Waste, or a method validated under This subpart also provides procedures subpart Q of this part, for chemical ex- for analyzing the samples and inter- traction of PCBs from individual and preting the results of the sampling. composite samples of PCB remediation Any person verifying completion of waste. Use Method 8082 from SW-846, or self-implementing cleanup and on-site a method validated under subpart Q of disposal of non-porous surfaces under this part, to analyze these extracts for § 761.61(a)(6), or verifying that decon- PCBs. tamination standards under

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§ 761.79(b)(3) are met, must use these meet the applicable standards or lev- procedures. els, surfaces may be recleaned and re- sampled. When resampling surfaces § 761.302 Proportion of the total sur- previously sampled to verify cleanup face area to sample. levels, use the sampling procedures in (a) Large nearly flat surfaces. Divide §§ 761.306 through 761.316 to resample the entire surface into approximately 1 the surfaces. If any sample site se- meter square portions and mark the lected coincides with a previous sam- portions so that they are clearly iden- pling site, restart the sample selection tified. Determine the sample location process until all resampling sites are in each portion as directed in § 761.304. different from any previous sampling (1) For large nearly flat surfaces con- sites. taminated by a single source of PCBs with a uniform concentration, assign § 761.306 Sampling 1 meter square sur- each 1 meter square surface a unique faces by random selection of halves. sequential number. (a) Divide each 1 meter square por- (i) For three or fewer 1 meter square tion where it is necessary to collect a areas, sample all of the areas. surface wipe test sample into two equal (ii) For four or more 1 meter square (or as nearly equal as possible) halves. areas, use a random number generator For example, divide the area into top or table to select a minimum of 10 per- and bottom halves or left and right cent of the areas from the list, or to se- halves. Choose the top/bottom or left/ lect three areas, whichever is more. right division that produces halves (2) For other large nearly flat sur- having as close to the shape of a circle faces, sample all of the one meter as possible. For example, a square is square areas. closer to the shape of a circle than is a (b) Small or irregularly shaped surfaces. rectangle and a rectangle having a For small surfaces having irregular length to width ratio of 2:1 is closer to contours, such as hand tools, natural the shape of a circle than a rectangle gas pipeline valves, and most exterior having a length to width ratio of 3:1. surfaces of machine tools, sample the entire surface. Any person may select (b) Assign a unique identifier to each sampling locations for small, nearly half and then select one of the halves flat surfaces in accordance with for further sampling with a random § 761.308 with the exception that the number generator or other device (i.e., maximum area in § 761.308(a) is <1 by flipping a coin). meter square. (c) Continue selecting progressively (c) Preparation of surfaces. Drain all smaller halves by dividing the pre- free-flowing liquids from surfaces and viously selected half, in accordance brush off dust or loose grit. with paragraphs (a) and (b) of this section, until the final selected half is § 761.304 Determining sample location. larger than or equal to 100 cm2 and 2 (a) For 1 square meter non-porous smaller than 200 cm . surface areas having the same size and (d) Perform a standard PCB wipe test shape, it is permissible to sample the on the final selected halves from each 1 same 10 cm by 10 cm location or posi- meter square portion. tion in each identical 1 square meter (e) The following is an example of ap- area. This location or position is deter- plying sampling by halves. Assume mined in accordance with § 761.306 or that the area to sample is a 1 meter § 761.308. square surface area (a square that has (b) If some 1 square meter surfaces sides 1 meter long). Assign each half to for a larger non-porous surface area one face of a coin. After flipping the have different sizes and shapes, sepa- coin, the half assigned to the face of rately select the 10 cm by 10 cm sam- the coin that is showing is the half se- pling position for each different 1 lected. square meter surface in accordance (1) Selecting the first half: with § 761.308. (i) For a square shape the top/bottom (c) If non-porous surfaces have been halves have the same shape as the left/ cleaned and the cleaned surfaces do not right halves when compared to a circle,

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i.e., regardless of which way the sur- the same shape when compared to a face is divided, each half is 1 half meter circle (both are rectangles having the wide by 1 meter long. Therefore, divide same dimensions). Therefore, choose the area either top/bottom or left/right. either left/right or top/bottom halves. For selecting the first half, this exam- This example will select from left/right ple will select from left/right halves. halves. (ii) A coin flip selects the left half. (ii) A coin flip selects the right half. The dimensions of this selected surface The dimensions of the selected surface 1 area are 1 meter high and ⁄2 meter are 1⁄8 meter by 1⁄4 meter. wide. (6) Selecting the sixth half: (2) Selecting the second half: (i) If the next selection of halves was (i) If the next selection of halves was left/right, the halves would be rectan- left/right, the halves would be rectangles four times as long as they are wide gles four times as long as they are wide (1⁄16 meter wide and 1⁄4 meter high. 1 ( ⁄4 meter wide and 1 meter high). Halves selected from top/bottom would Halves selected from top/bottom would be square (1⁄8 meter on a side). There- 1 be square ( ⁄2 meter on a side). There- fore, select the next halves top/bottom, fore, select the next halves top/bottom, because the shape of the top/bottom because the shape of the top/bottom halves (square) are closer to the shape halves (square) is closer to the shape of of a circle than the shape of the left/ a circle than the shape of the left/right right halves (long narrow rectangles). halves (long narrow rectangles). (ii) A coin flip selects the top half. (ii) A coin flip selects the top half. The dimensions of this selected surface The dimensions of this selected surface are 1⁄8 meter high and 1⁄8 meter wide or area are 1⁄2 meter high and 1⁄2 meter wide. 12.5 cm by 12.5 cm. (3) Selecting the third half: (7) Collect a standard wipe test sam- (i) Just as for the selection of the ple in the sixth half. Since the dimen- first half, which divided the original sions of half of the sixth half would be square area, both the left/right and the 12.5 cm by 6.25 cm, the area (approxi- top/bottom halves have the same shape mately 78 cm2) would be less than the when compared to a circle (both are required 100 cm2 minimum area for the rectangles having the same dimen- standard wipe test. Therefore, no fur- sions). Therefore, choose either left/ ther sampling by halves is necessary. right or top/bottom halves. This exam- Take the standard wipe test samples of ple will select from left/right halves. the entire selected sixth half. (ii) A coin flip selects the right half. The dimensions of this selected surface § 761.308 Sample selection by random number generation on any two-di- are 1⁄4 meter by 1⁄2 meter. mensional square grid. (4) Selecting the fourth half: (i) If the next selection of halves was (a) Divide the surface area of the left/right, the halves would be rectan- non-porous surface into rectangular or gles four times as long as they are wide square areas having a maximum area (1⁄8 meter wide and 1⁄2 meter high. of 1 square meter and a minimum di- Halves selected from top/bottom would mension of 10 centimeters. be square (1⁄4 meter on a side). There- (b) Measure the length and width, in fore, select the next halves top/bottom, centimeters, of each area created in because the shape of the top/bottom paragraph (a) of this section. Round off halves (square) are closer to the shape the number of centimeters in the of a circle than the shape of the left/ length and the width measurements to right halves (long narrow rectangles). the nearest centimeter. (ii) A coin flip selects the bottom (c) For each 1 square meter area cre- half. The dimensions of this selected ated in accordance with paragraph (a) surface area are 1⁄4 meter high and 1⁄4 of this section, select two random num- meter wide. bers: one each for the length and width (5) Selecting the fifth half: borders measured in paragraph (b) of (i) Just as for the selection of the this section. An eligible random num- first and third halves, both the left/ ber can be from zero up to the total right and the top/bottom halves have width, minus 10 centimeters.

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(d) Locate the 10 centimeter by 10 posite a maximum of three adjacent centimeter sample. samples. (1) Orient the 1 square meter surface (b) Compositing samples from surfaces area so that, when you are facing the to be disposed of off-site or on-site. (1) area, the length is left to right and the For small or irregularly shaped sur- width is top to bottom. The origin, or faces, composite a maximum of three reference point for measuring selected adjacent samples. random numbers of centimeters to the (2) For large nearly flat surfaces, sampling area, is on the lower left cor- composite a maximum of 10 adjacent ner when facing the surface. samples. (2) Mark the random number selected for the length distance, in centimeters, § 761.314 Chemical analysis of stand- from the origin to the right (at the bot- ard wipe test samples. tom of the area away from the origin). Perform the chemical analysis of (3) From the marked length distance standard wipe test samples in accord- on the bottom of the area, move per- ance with § 761.272. Report sample re- pendicularly up from the bottom of the sults in micrograms per 100 cm2. area into the area for the distance randomly selected for the width. § 761.316 Interpreting PCB concentra- (4) Use the point determined in para- tion measurements resulting from graph (d)(3) of this section as the lower this sampling scheme. left corner of the 10 centimeter by 10 (a) For an individual sample taken centimeter sample. from an approximately 1 meter square § 761.310 Collecting the sample. portion of the entire surface area and not composited with other samples, the Use the standard wipe test as defined status of the portion is based on the in § 761.123 to sample one 10 centimeter surface concentration measured in that 2 by 10 centimeter square (100 cm ) area sample. If the sample surface con- to represent surface area PCB concentration is not equal to or lower centrations of each square meter or than the cleanup level, by inference the fraction of a square meter of a nearly entire 1 meter area, and not just the flat, non-porous surface. For small sur- immediate area where the sample was faces, use the same procedure as for the standard wipe test, only sample the en- taken, is not equal to or lower than the tire area, rather than 10 centimeter by cleanup level. 10 centimeter squares. (b) For areas represented by the measurement results from compositing § 761.312 Compositing of samples. more than one 10 centimeter by 10 centimeter sample, the measurement for For a surface originally contaminated by a single source of PCBs with the composite is the measurement for a uniform concentration, it is permis- the entire area. For example, when sible to composite surface wipe test there is a composite of 10 standard samples and to use the composite wipe test samples representing 9.5 measurement to represent the PCB square meters of surface area and the concentration of the entire surface. result of the analysis of the composite Composite samples consist of more is 20 μg/100 cm2, then the entire 9.5 than one sample gauze extracted and square meters has a PCB surface con- chemically analyzed together resulting centration of 20 μg/100 cm2, not just the in a single measurement. The com- area in the 10 cm by 10 cm sampled posite measurement represents an areas. arithmetic mean of the composited (c) For small surfaces having irreg- samples. ular contours, where the entire surface (a) Compositing samples from surfaces was sampled, measure the surface area. to be used or reused. For small or irregu- Divide 100 cm2 by the surface area and larly shaped surfaces or large nearly multiply this quotient by the total flat surfaces, if the surfaces are con- number of micrograms of PCBs on the taminated by a single source of PCBs surface to obtain the equivalent meas- with a uniform concentration, com- urement of micrograms per 100 cm2.

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Subpart Q—Self-Implementing Al- would have to be present in the com- ternative Extraction and parison study compounds at the same Chemical Analysis Procedures levels found, or at the highest levels expected to be found, in the PCB reme- for Non-liquid PCB Remedi- diation waste. As another example, for ation Waste Samples PCB remediation waste which had been solvent washed with liquid amines to SOURCE: 63 FR 35468, June 29, 1998, unless remove PCBs, comparison study sam- otherwise noted. ples would have to contain concentrations of these amines at the same lev- § 761.320 Applicability. els found, or at the highest levels ex- This subpart describes self-imple- pected to be found, in the PCB remedi- menting comparison testing require- ation waste. ments for chemical extraction and (b) Prior to initiating the comparison chemical analysis methods used as an study, confirm the following PCB con- alternative to the methods required in centrations in the comparison study §§ 761.272 or 761.292. Any person con- samples using the methods specified in ducting comparison testing under this § 761.292. All samples of non-liquid PCB subpart must comply with the require- remediation waste must have PCB con- ments of § 761.80(i), including notifica- centrations between 0.1 and 150 ppm. tion. Use alternative methods only (1) A minimum of three comparison after successful completion of these study samples must have PCB con- comparison testing requirements and centrations above the cleanup level after documentation of the results of specified for the site in § 761.61(a)(4) and the testing. a minimum of three comparison study samples must have PCB concentrations § 761.323 Sample preparation. below the specified cleanup level. (a) The comparison study requires (2) At least one comparison study analysis of a minimum of 10 samples sample must have a PCB concentration weighing at least 300 grams each. Sam- ≥90 percent and ≤100 percent of the ples of PCB remediation waste used in cleanup level. the comparison study must meet the (3) At least one comparison study following three requirements. sample must have a PCB concentration (1) The samples must either be taken ≥100 percent and ≤110 percent of the from the PCB remediation waste at the cleanup level. cleanup site, or must be the same kind (c) If the comparison study samples of material as that waste. For example, do not have the concentrations or con- if the waste at the cleanup site is centration ranges required by para- sandy soil, you must use the same kind graph (b) of this section, for purposes of sandy soil in the comparison study. of use in this chemical extraction and Do not use unrelated materials such as chemical analysis comparison study, a clay soil or dredged sediments in place person may adjust PCB concentrations of sandy soil. by dilution. Any excess material re- (2) PCB remediation waste may consulting from the preparation of these tain interferences which confound or samples, which is not used as an ana- hamper sample extraction and chem- lytical sample, is regulated as the PCB ical analysis. These interferences may concentration in the component having be from chemicals or other attributes the highest PCB concentration of the preexisting in the waste material, re- component materials in the sample. sulting from the PCB contamination source, or resulting from treatment to § 761.326 Conducting the comparison remove or destroy PCBs. Comparison study. study samples must also contain these Extract or analyze the comparison interfering materials to demonstrate study samples using the alternative successful analysis in their presence. method. For an alternative extraction For example, a PCB remediation waste method or alternative analytical meth- may have been co-disposed with chloro- od to be comparable to the methods re- benzene solvents or chlorinated pes- quired in § 761.292, all of the following ticides. These chlorinated compounds conditions must be met.

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(a) All samples having PCB con- disposal must be in the form of either centrations greater than or equal to flattened or roughly conical piles. This the level of concern, as measured by subpart also contains a procedure for the methods required in § 761.292, are contemporaneous sampling of waste as found to be greater than or equal to it is being generated. the level of concern as measured by the alternative method (no false nega- § 761.346 Three levels of sampling. tives). To select a sample of the waste and (b) Only one sample which contains prepare it for chemical extraction and PCBs at a level less than the level of analysis, there are three required lev- concern, as measured by the methods els of random sampling. required in § 761.292, is found to have a (a) First, select a single 19-liter (5 PCB concentration greater than the gallon) portion from a composite accu- level of concern as measured by the al- mulated either contemporaneously ternative method (false positive); and with the generation of the waste or by all other samples which contain PCBs sampling an existing pile of waste. Col- at levels less than the level of concern, lection procedures for the first level of as measured by the methods required sampling from existing piles of waste in § 761.292, are found by the alternative are in § 761.347. Collection procedures method to have PCBs less than the for the first level of sampling from a level of concern (there are no addi- contemporaneous generation of waste tional false positives). are in § 761.348. Compositing requirements and requirements for the sub- Subpart R—Sampling Non-Liquid, sampling of composite samples to re- Non-Metal PCB Bulk Product sult in a single 19-liter sample are in Waste for Purposes of Charac- § 761.350. Send the 19-liter sample to the terization for PCB Disposal in laboratory for the second and third lev- Accordance With § 761.62, els of sampling, including particle size reduction for leach testing and drying and Sampling PCB Remedi- as required by § 761.1(b)(4). ation Waste Destined for Off- (b) Second, at the laboratory, select Site Disposal, in Accordance one quarter of the 19-liter sample. Pro- With § 761.61 cedures the laboratory must use for this second level of sample selection SOURCE: 63 FR 35469, June 29, 1998, unless appear in § 761.353. otherwise noted. (c) Third, select a 100 gram subsample from the second level sub- § 761.340 Applicability. sample. Procedures the laboratory Use the procedures specified in this must use for this third level of sample subpart to sample the following types selection appear in § 761.355. of waste when it is necessary to analyze the waste to determine PCB con- § 761.347 First level sampling—waste centration or leaching characteristics from existing piles. for storage or disposal. (a) General. Sample piles that are ei- (a) Existing accumulations of non- ther specifically configured for sam- liquid, non-metal PCB bulk product pling (see paragraph (b) of this section) waste. or that are of conical shape (see para- (b) Non-liquid, non-metal PCB bulk graph (c) of this section). If sampling product waste from processes that con- from either of these shapes is not pos- tinuously generate new waste. sible, conduct contemporaneous sam- (c) Non-liquid PCB remediation pling, in accordance with the proce- waste from processes that continuously dures in § 761.348, or obtain the ap- generate new waste, that will be sent proval of the Regional Administrator off-site for disposal. for an alternate sampling plan in accordance with § 761.62(c). § 761.345 Form of the waste to be sam- (b) Specifically configured piles. A spe- pled. cifically configured pile is a single flat- PCB bulk product waste and PCB re- tened pile in the shape of a square or mediation waste destined for off-site rectangle having no restrictions on

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length or width but restricted to 30 cm there are too many piles to spread out (1 foot) in depth. A square shaped pile in the space available, use the fol- facilitates sampling site selection for lowing procedure to sample the piles. the first level sample. Select eight 19- This procedure assumes that the shape liter samples from the pile and com- of the piles is analogous to a cone; that posite them into one 19-liter sample as is, having a circular base with PCB follows: bulk product waste or PCB remediation (1) Divide the pile into quarters. waste destined for off-site disposal (2) Divide each of the quarter sec- stacked up uniformly to a peak that is tions into quarters (i.e., into sixteenths a point centered above the center of of the original pile). the circular base. Collect eight 19-liter (3) Select two sixteenths from each of samples as follows: the four quarters, according to one of (1) Collecting samples from more than the two following options: one pile. If the PCB bulk product waste (i) Randomly select the two six- or PCB remediation waste consists of teenths from one quarter and sample more than one pile or container, assign the sixteenths occupying the same po- each pile or container an integer num- sitions in each of the other three quar- ber and then generate seven random in- ters. teger numbers to select the piles from (ii) Randomly select two sixteenths which you will collect samples. It is from each of the four quarters (i.e., possible that this random selection perform a random selection four dif- procedure will result in selecting the ferent times). same pile number more than once, even (4) At this point the eight selected if seven or more piles are present. If so, sixteenths undergo further division and sample the pile once and restart the sample selection. Divide each of the sampling collection process to collect eight selected sixteenths into four additional samples. Do not collect mul- equal parts. Using a random number tiple samples from the same location generator or random number table, sein the pile. lect one of the four equal parts from (2) Collecting samples from a single pile. each of the eight equal areas. If each of If only one pile or container is present, the four equal parts has a volume >76 collect all eight samples from the same liters when projected downwards 30 cm, pile. continue to divide each selected area (3) Setting up the sample site selection into four equal parts, and select one of system from a pile. Locate a sample in a the parts, until each selected area has pile by the use of three parameters: a a volume of <76 liters but ≥19 liters. particular radial direction, ‘‘r,’’ from When projected to a depth of 30 cm, a the peak at the center of the pile to the square having a 25 cm side or a circle outer edge at the base of the pile; a having a diameter of approximately point, ‘‘s,’’ along that radial direction 28.5 cm equals a volume of approxi- between the peak of the pile and the mately 19 liters. The volume of 76 liters outer edge of the base of the pile; and is equal to the volume enclosed by a a depth, ‘‘t’’, beneath point ‘‘s.’’ The square having a side of 50 cm (or other top of the sample material will be shape having an area of 250 cm2) pro- below depth t, at point s, on radius r. jected to a depth of 30 cm. Use a rod, dowel, stake, or broom han- (5) Take one sample of approximately dle as a marker. Nail or otherwise fas- 19 unsorted liters of waste from each of ten to the top of the marker two pieces the eight selected areas. Place each of string or cord of sufficient length sample into a separate 19-liter con- and strength to reach from the top of tainer, allowing only sufficient space the marker at the top of the pile to the at the top of the container to secure farthest peripheral edge at the bottom the lid. of the pile, when the marker is posi- (6) Composite the eight 19-liter sam- tioned at the top or apex of the pile. ples in accordance with § 761.350. Pound or push the marker into the top (c) Conical-shaped piles. If it is nec- center (apex) of the pile, downward to- essary to sample a pile which is too ward the center of the base. Insert the large to be spread on the site to a uni- marker for at least 30 cm or one foot form thickness of 1 foot or 30 cm, or if until the marker is rigidly standing on

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its own, even when the cord is pulled at the point s selected in paragraph tight to the bottom peripheral edge of (c)(3)(ii)(B) of this section. The marked the pile. Ensure that the marker pro- and numbered device shall be of suffi- trudes from the top of the pile sufficient strength to be forced down ciently to allow the strings to move through the maximum depth of the pile easily around the pile when they are and sufficient length to measure the pulled tight. Select the three param- depth of the waste in the pile at any eters and the sampling location as fol- point. lows: (B) Take the measuring device, con- (i) Determine the radial component structed according to paragraph (r) of the location for each sample. (c)(3)(iii)(A) of this section, and at posi- (A) Tie to a stake or otherwise fasten tion s, push the end of the device one of the strings at ‘‘b,’’ the bottom of marked with zero straight down into the pile, as a reference point for find- the pile until it reaches the bottom of ing r. the pile or ground level. The vertical (B) Measure the circumference ‘‘c,’’ the distance around the bottom of the distance ‘‘v’’ is the number of centi- pile. Determine r from b in one of two meters from the surface of the pile at ways: point s on the string to the bottom of (1) Multiply c by a randomly gen- the pile or ground level. Read the dis- erated fraction or percentage of one. tance v on the measuring device at the (2) Select a random number between surface of the pile. From the distance one and the total number of centi- v, determine t, in one of two ways: meters in c. (1) Randomly generate a fraction of (C) Locate r by starting at b, the one and multiply the fraction times v. place where the fixed string meets the (2) Select a random number between base of the pile, and travel clockwise zero and the total number of centi- around the edge of the pile at the base meters of the vertical distance v. for the distance you selected in para- (iv) Dig a hole straight down into the graph (c)(3)(i)(B) of this section. pile for t centimeters (inches) from the (D) Fasten the second string at the surface of the pile at s. selected distance. The second string (v) At depth t, directly under the s marks the first parameter r. mark on the string, outline the top of (ii) Determine the second parameter the sample container and collect (shov- s of the location for each sample. el) all waste under the outline in the (A) Measure the distance, l, along the following order of preference in para- string, positioned in paragraph graphs (c)(3)(v)(A) through (c)(3)(v)(C) (c)(3)(i)(D) of this section, from the top of this section. It is possible that some to the bottom of the pile at the se- of the eight sampling locations will not lected radial distance r. Determine the provide 19 liters of sample. distance s from l in one of two ways: (A) For a depth of 30 cm. (1) Multiply l by a randomly gen- (B) Until the container is full. erated fraction or percentage of one. (2) Select a random number between (C) Until the ground level is reached. one and the total number of centi- (d) Compositing the samples. Composite meters in l. the eight 19-liter samples and sub- (B) Mark, for example by placing a sample in accordance with § 761.350. piece of tape on the string positioned Send the subsample to a laboratory for according to paragraph (c)(3)(i)(D) of further sampling as described in this section, the distance s, up from the §§ 761.353 and 761.355 and for chemical bottom of the pile on the string at r. extraction and analysis. If there is in- (iii) Determine the third and final pa- sufficient sample for a 19-liter sample rameter t of the location for each sam- from the composite sample composed ple. of the eight iterations of sample site (A) Mark and number 1 cm intervals selection, according to the procedures from one end of a rigid device, for ex- in paragraphs (c)(3)(i) through (c)(3)(v) ample a rod, dowel, stake, or broom of this section, select additional sam- handle, for measuring the distance ple sites, collect additional samples from the top of the pile to the bottom and composite the additional waste in

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the samples until a minimum of 19 li- (1) Option one. Place all of the con- ters is in the composite. tents of all 19-liter samples that you [63 FR 35469, June 29, 1998, as amended at 64 collected into a 209 liter (55 gallon) FR 33762, June 24, 1999] drum or similar sized, cylinder-shaped container. Completely close the con- § 761.348 Contemporaneous sampling. tainer, and roll it 10 or more complete Contemporaneous sampling is pos- revolutions to mix the contents. sible when there is active generation of (2) Option two. Add the 19-liter sam- waste and it is possible to sample the ples one at a time to a 209 liter (55 gal- waste stream as it is generated. Collect lon) drum. Between the addition of eight 19-liter samples as follows. each 19-liter sample, stir the composite (a) Collect each sample by filling a using a broom handle or similar long, 19-liter (5 gallon) container at a loca- narrow, sturdy rod that reaches the tion where the PCB bulk product waste bottom of the container. Stir the mix- is released from the waste generator ture for a minimum of 10 complete rev- onto a pile or into a receptacle con- olutions of the stirring instrument tainer before the waste reaches the pile around the container at a distance ap- or receptacle container. proximately half way between the out- (b) Determine a sample collection side and center of the container. start time using a random number gen- (b) Selecting a 19-liter subsample from erator or a random number table to se- the composite. Once the composite is lect a number between 1 and 60. Collect mixed, pour the mixture of waste out the first sample at the randomly se- on a plastic sheet and either divide it lected time in minutes after start up of into 19-liter size piles or make one the waste output, or if the waste is cur- large pile. rently being generated, after the ran- (1) From 19-liter sized piles, use a dom time is selected. For example, if random number generator or random the randomly selected time is 35, begin number table to select one of the piles. collection 35 minutes after the start up (2) From one large pile, flatten the of waste generation. Similarly, if waste pile to a depth of 30 cm and divide it output is ongoing and the random start determination occurred at 8:35 a.m., into 4 quarters of equal size. Use a ran- collect the first sample at 9:10 a.m. (35 dom number generator or random num- minutes after the random start deter- ber table to select one quarter of the mination). pile. Further divide the selected quar- (c) Collect seven more samples, one ter pile into 19-liter portions and use a every 60 minutes after the initial sam- random number generator or random ple is collected. If the waste output number table to select one 19-liter por- process stops, stop the 60–minute inter- tion. A square having a 25 cm side or a val time clock. When the process re- circle having a diameter of approxi- starts, restart the 60–minute interval mately 28.5 cm when projected down- time clock and complete the incom- wards 30 cm equals approximately 19 li- plete 60–minute interval. ters. (d) Composite the eight 19-liter sam- (c) Transferring the sample to the ana- ples and subsample in accordance with lytical laboratory. Place the selected 19- § 761.350. liter subsample in a container, approved for shipment of the sample, to § 761.350 Subsampling from composite the chemical extraction and analysis samples. laboratory, for the next step in sample (a) Preparing the composite. Composite selection in accordance with § 761.353. the samples (eight from a flattened pile; eight or more from a conical pile; § 761.353 Second level of sample selec- eight from waste that is continuously tion. generated) and select a 19-liter sub- The second level of sample selection sample for shipment to the chemical reduces the size of the 19-liter sub- extraction and analysis laboratory for sample that was collected according to further subsampling. There are two op- either § 761.347 or § 761.348 and subsam- tions for the preparation of the com- pled according to § 761.350. The purpose posite: of the sample size reduction is to limit

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the amount of time required to manu- sample to 100 grams which is suitable ally cut up larger particles of the waste for the chemical extraction and anal- to pass through a 9.5 millimeter (mm) ysis procedure. screen. (a) Divide the subsample resulting (a) Selecting a portion of the subsample from conducting the procedures in for particle size reduction. At the chem- § 761.353 of this part into 100 gram por- ical extraction and analysis labora- tions. tory, pour the 19-liter subsample onto a (b) Use a random number generator plastic sheet or into a pan and divide or random number table to select one the subsample into quarters. Use a ran- 100 gram size portion as a sample for a dom number generator or random num- procedure used to simulate leachate ber table to select one of these quarters. generation. (b) Reduction of the particle size by the (c) Dry the 100 gram sample, selected use of a 9.5 mm screen. Collect the con- after conducting the procedure in para- tents of the selected quarter of waste graph (b) of this section, for 10 to 15 resulting from conducting the proce- hours in a drying oven at 100 °C and dures in paragraph (a) of this section cool it to the analytical laboratory and shake the waste in a 9.5 mm room temperature before analysis screen. Separate the waste material using a procedure used to simulate which passes through the screen from leachate generation. This sample was the waste material which does not pass dried previously in the larger quantity through the screen. Manually cut or sample at the second level of sampling otherwise reduce the size of all parts of (§ 761.353(c)) and is dried a second time the waste portion which did not pass here (in the third level of sample selec- through the 9.5 mm screen, such that tion). This dried and cooled sample each part of the waste shall pass must weigh at least 50 grams. through the 9.5 mm screen by shaking. (d) If the dried and cooled sample (c) Drying the reduced particle size weighs <50 grams, select additional 100 waste. Dry all of the waste portion re- gram portions of sample one at a time sulting from conducting the procedures by repeating the directions in para- in paragraph (b) of this section, from 10 graph (b) and (c) of this section, and to 15 hours in a drying oven at 100 °C. add each additional 100 gram portion of Allow the dried waste to cool to room temperature. sample to the first 100 gram portion (d) Mixing the dried waste. Place all of until at least 50 grams of dried mate- the waste resulting from conducting rial is in the sample to be analyzed the procedures in paragraph (c) of this using a procedure used to simulate section in a 19-liter pail or similarly leachate generation. sized, cylinder-shaped container. Mix the dried material according to one of § 761.356 Conducting a leach test. the two following options: No method is specified as a procedure (1) First mixing option. Completely used to simulate leachate generation. close the container and roll the container a minimum of 10 complete revo- § 761.357 Reporting the results of the lutions to mix the contents. procedure used to simulate leach- (2) Second mixing option. Use a sturdy ate generation. stirring rod, such as a broom handle or Report the results of the procedure other device that reaches the bottom of used to simulate leachate generation the container, to stir the waste for a as micrograms PCBs per liter of ex- minimum of 10 complete revolutions tract from a 100 gram sample of dry around the container at a distance ap- bulk product waste. Divide 100 grams proximately half way between the out- by the grams in the sample and mul- side and the center of the container. tiply this quotient by the number of § 761.355 Third level of sample selec- micrograms PCBs per liter of extract tion. to obtain the equivalent measurement The third level of sample selection from a 100 gram sample. further reduces the size of the sub-

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§ 761.358 Determining the PCB con- and absorbent pads used in the second centration of samples of waste. rinse of contaminated surfaces may be Use either Method 3500B/3540C or reused to wash contaminated surfaces. Method 3500B/3550B from EPA’s SW-846, (b) Capture and contain all solvents Test Methods for Evaluating Solid and cleaners for reuse, decontamina- Waste, or a method validated under tion, or disposal. Clean organic sol- subpart Q of this part, for chemical ex- vents contain <2 ppm PCBs. Clean traction of PCBs from individual and water contains <3 ppb PCBs. composite samples of PCB bulk product waste. Use Method 8082 from SW- § 761.369 Pre-cleaning the surface. 846, or a method validated under sub- If visible PCB-containing liquid is part Q of this part, to analyze these ex- present on the surface to be cleaned, tracts for PCBs. thoroughly wipe or mop the entire sur- § 761.359 Reporting the PCB con- face with absorbent paper or cloth centrations in samples. until no liquid is visible on the surface. Report all sample concentrations as § 761.372 Specific requirements for rel- ppm by weight on a dry weight basis. atively clean surfaces. Subpart S—Double Wash/Rinse For surfaces that do not appear dusty Method for Decontaminating or grimy before a spill, such as glass, automobile surfaces, newly-poured con- Non-Porous Surfaces crete, and desk tops, use the double wash/rinse procedures in this section. SOURCE: 63 FR 35472, June 29, 1998, unless (a) First wash. Cover the entire sur- otherwise noted. face with organic solvent in which § 761.360 Background. PCBs are soluble to at least 5 percent The double wash/rinse procedure is by weight. Contain and collect any used to quickly and effectively remove runoff solvent for disposal. Scrub rough PCBs on surfaces. It is important to se- surfaces with a scrub brush or dispos- lect and use the proper cleanup equip- able scrubbing pad and solvent such ment, to conduct the procedure cor- that each 900 cm2 (1 square foot) of the rectly so as not to redistribute PCBs, surface is always very wet for 1 and to comply with disposal require- minute. Wipe smooth surfaces with a ments for all cleanup materials. solvent-soaked, disposable absorbent pad such that each 900 cm2 (1 square § 761.363 Applicability. foot) is wiped for 1 minute. Any surface The double wash/rinse procedure in- <1 square foot shall also be wiped for 1 cludes two washing steps and two rins- minute. Wipe, mop, and/or sorb the sol- ing steps. The two washing and rinsing vent onto absorbent material until no steps are slightly different depending visible traces of the solvent remain. on whether a contaminated surface was (b) First rinse. Wet the surface with relatively clean before the spill (see clean rinse solvent such that the entire § 761.372), or whether the surface was surfaces is very wet for 1 minute. Drain coated or covered with dust, dirt, and contain the solvent from the sur- grime, grease or another absorbent ma- face. Wipe the residual solvent off the terial (see § 761.375). drained surface using a clean, dispos- § 761.366 Cleanup equipment. able absorbent pad until no liquid is visible on the surface. (a) Use scrubbers and absorbent pads (c) Second wash. Repeat the proce- that are not dissolved by the solvents dures in paragraph (a) of this section. or cleaners used, and that do not shred, crumble, or leave visible fragments on The rinse solvent from the first rinse the surface. Scrubbers and absorbent (paragraph (b) of this section) may be pads used to wash contaminated sur- used. faces must not be reused. Scrubbers (d) Second rinse. Repeat the proce- and absorbent pads for rinsing must dures in paragraph (b) of this section. not contain ≥2 ppm PCBs. Scrubbers

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§ 761.375 Specific requirements for ers, and absorbent materials in accord- surfaces coated or covered with ance with § 761.65. dust, dirt, grime, grease, or another absorbent material. Subpart T—Comparison Study for (a) First wash. Cover the entire sur- Validating a New Perform- face with concentrated or industrial ance-Based Decontamination strength detergent or non-ionic surfac- Solvent Under § 761.79(d)(4) tant solution. Contain and collect all cleaning solutions for proper disposal. SOURCE: 63 FR 35473, June 29, 1998, unless Scrub rough surfaces with a scrub otherwise noted. brush or scrubbing pad, adding cleaning solution such that the surface is al- § 761.380 Background. ways very wet, such that each 900 cm2 This subpart provides self-imple- (1 square foot) is washed for 1 minute. menting criteria for validating the Wipe smooth surfaces with a cleaning conditions for use in performance- solution-soaked disposable absorbent based decontamination of solvents pad such that each 900 cm2 (1 square other than those listed in § 761.79(c)(3) foot) is wiped for 1 minute. Wash any and (c)(4). Any person may use this surface <1 square foot for 1 minute. subpart for validating either a chem- Mop up or absorb the residual cleaner ical formulation or a product with a solution and suds with a clean, dispos- trade name whether or not the con- able, absorbent pad until the surface stituents of the product are propri- appears dry. This cleaning should re- etary. move any residual dirt, dust, grime, or other absorbent materials left on the § 761.383 Applicability. surface during the first wash. Use the self-implementing decon- (b) First rinse. Rinse off the wash so- tamination procedure only on smooth, lution with 1 gallon of clean water per non-porous surfaces that were once in square foot and capture the rinse contact with liquid PCBs. Decon- water. Mop up the wet surface with a tamination procedures under this sub- clean, disposable, absorbent pad until part shall exactly parallel § 761.79(c)(3) the surface appears dry. and (c)(4), except that the procedures (c) Second wash. Follow the procedure described in § 761.79(c)(3)(iii) and in § 761.372(a). (c)(3)(iv) and (c)(4)(iii), (c)(4)(iv) and (d) Second rinse. Follow the procedure (c)(4)(vii) may be revised to contain pa- in § 761.372(b). rameters validated in accordance with this subpart. § 761.378 Decontamination, reuse, and disposal of solvents, cleaners, and § 761.386 Required experimental con- equipment. ditions for the validation study and subsequent use during decon- (a) Decontamination. Decontaminate tamination. solvents and non-porous surfaces on The following experimental condi- equipment in accordance with the tions apply for any solvent: standards and procedures in § 761.79(b) (a) Temperature and pressure. Conduct and (c). the validation study and perform de- (b) Reuse. A solvent may be reused so contamination at room temperature long as its PCB concentration is <50 (from ≥15 °C to ≤30 °C) and at atmos- ppm. Decontaminated equipment may pheric pressure. be reused in accordance with § 761.30(u). (b) Agitation. Limit the movement in Store solvents and equipment for reuse the solvent to the short-term move- in accordance with § 761.35. ment from placing the contaminated (c) Disposal. Dispose of all solvents, surface into the soak solvent and from cleaners, and absorbent materials in removing the surface from the soak accordance with § 761.79(g). Dispose of solvent. equipment in accordance with (c) Time of soak. Soak the surface for § 761.61(a)(5)(v)(A), or decontaminate in a minimum of 1 hour. accordance with § 761.79(b) or (c). Store (d) Surface conditions for the validation for disposal equipment, solvents, clean- study. Prior to beginning the validation

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study, ensure that there are no free- tions. If you desire to change more flowing liquids on surfaces and that than one of the requirements in this surfaces are dry (i.e., there are no liq- section, you must conduct a new study uids visible without magnification). to validate the decontamination under Also ensure that surfaces are virtually the desired conditions. free from non-liquid residues, corro- (a) The study apparatus is not stand- sion, and other defects which would ardized. Critical components of the prevent the solvent from freely circu- study are the PCB material (for exam- lating over the surface. ple MODEF or some other spiking solu- (e) Confirmatory sampling for the vali- tion), the volume of the soaking sol- dation study. Select surface sample lo- vent, and the area of the contaminated cations using representative sampling surface. The EPA study used beakers or a census. Sample a minimum area of and shallow dishes as the experimental 100 cm2 on each individual surface in vessels to contain the surface and sol- the validation study. Measure surface vent during the soaking process. In concentrations using the standard wipe order to minimize surface-to-volume test, as defined in § 761.123, from which ratios, it is convenient to utilize flat a standard wipe sample is generated for contaminated surfaces and shallow sol- chemical analysis. Guidance for wipe vent containers. During the validation sampling appears in the document enti- study, use the same ratio of contami- tled ‘‘Wipe Sampling and Double Wash/ nated surface area to soak solvent vol- Rinse Cleanup as Recommended by the ume as would be used during actual de- Environmental Protection Agency PCB contamination. It is also permissible to Spill Cleanup Policy,’’ available on use a smaller surface area to soaking EPA’s Web site at http://www.epa.gov/ solvent volume than used in the valida- pcb, or from the Program Management, tion study, so long as all other required Communications, and Analysis Office, parameters are used as validated in the Office of Resource Conservation and confirmation required in § 761.386 (a) Recovery (5305P), Environmental Pro- through (f), and paragraphs (a) through tection Agency, 1200 Pennsylvania (c) of this section. Do not use a larger Ave., NW., Washington, DC 20460–0001. surface-area-to-solvent-volumes ratio (f) Concentration of PCBs. The method or different kind of solvent based on validated may be used only to decon- the results of the validation study. taminate surfaces containing PCBs at (b) Except for the minimum soak concentrations on which the validation time of 1 hour (as required in study was performed and lower con- § 761.386(c)), the length of soak time is centrations. not otherwise restricted in the valida- [63 FR 35473, June 29, 1998, as amended at 72 tion study. The soak time used in the FR 57241, Oct. 9, 2007; 74 FR 30235, June 25, validation study, however, is a use re- 2009] quirement for subsequent decontamination using the solvent being § 761.389 Testing parameter require- validated. It is permissible to use ments. longer soak times for decontamination There are no restrictions on the vari- than the soak time used in the valida- able testing parameters described in tion study, if all other parameters re- this section which may be used in the quired in § 761.386, and paragraphs (a) validation study. The conditions dem- and (c) of this section are used. onstrated in the validation study for (c) There is no restriction on the these variables shall become the re- kind of material containing PCBs to quired conditions for decontamination use to create the surface contamina- using the solvent being validated and tion for the validation study. There is shall replace the comparable condi- also no restriction on the level of start- tions in § 761.79(b)(3) through (b)(6). ing PCB surface concentration. It is There are limited potential options for permissible to use lower concentra- varying a single requirement in this tions of PCB than the concentration section. If you change one of these used in the validation study, if all variable requirements, change it only other parameters required in § 761.386 in the way listed in this section and do (a) through (f), and paragraphs (a) not change any other validated condi- through (c) of this section are used.

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§ 761.392 Preparing validation study § 761.395 A validation study. samples. (a) Decontaminate the following pre- (a)(1) To validate a procedure to de- pared sample surfaces using the se- contaminate a surface contaminated lected testing parameters and experi- with a spill from liquid of a known con- mental conditions. Take a standard centration, contaminate (spike) the wipe sample of the decontaminated surface to be used in the validation surface. study as follows: (1) At least one uncontaminated sur- (i) Use a spiking solution made of face. The surface levels of PCBs on the PCBs mixed with a solvent to contami- uncontaminated surface must be <1 μg/ nate clean surfaces. Clean surfaces are 100 cm2. surfaces having PCB surface concentra- (2) At least seven contaminated sur- tions <1 μg/100 cm2 before intentionally faces. contaminating the surface. (b)(1) Use SW-846, Test Methods for (ii) Prior to contaminating a surface Evaluating Solid Waste methods for for the validation study, mark the sur- sample extraction and chemical anal- face sampling area to assure that it is ysis as follows: Use Method 3500B/3540C completely covered with the spiking or Method 3500B/3550B for the extrac- solution. tion and cleanup of the extract and (iii) Deliver the spiking solution onto Method 8082 for the chemical analysis, the surface, covering all of the sam- or methods validated under subpart Q pling area. Contain any liquids which of this part. spill or flow off the surface. Allow the (2) Report all validation study sur- spiking solution to drip drain off into a face sample concentrations on the container and then evaporate the spik- basis of micrograms of PCBs per 100 ing solution off the contaminated sur- cm2 of surface sampled. face prior to beginning the validation (c) Following completion of the vali- study. Contaminate a minimum of dation study, measurements from the eight surfaces for a complete valida- contaminated surfaces must have an ≤ μ 2 tion study. arithmetic mean of 10 g/100 cm . If μ 2 (iv) As a quality control step, test at the arithmetic mean is >10 g/100 cm , least one contaminated surface to de- then the validation study failed and the solvent may not be used for decon- termine the PCB concentration to tamination under § 761.79(d)(4) accord- verify that there are measurable suring to the parameters tested. face levels of PCBs resulting from the contamination before soaking the sur- § 761.398 Reporting and record- face in the decontamination solvent. keeping. The surface levels of PCBs on the con- (a) Submit validation study results taminated surfaces must be ≥20 μg/100 to the Director, Office of Resource Con- cm2. servation and Recovery (5301P), Envi- (2) To validate a procedure to decon- ronmental Protection Agency, 1200 taminate a specified surface concentra- Pennsylvania Ave., NW., Washington, tions of PCBs as measured by a stand- DC 20460–0001, prior to the first use of a ard wipe sample, contaminate a min- new solvent for alternate decontamina- imum of 10 surfaces. Contaminate all tion under § 761.79(d)(4). The use of a the surfaces identically following the new solvent is not TSCA Confidential procedures in paragraph (a)(1) of this Business Information (CBI). From time section and measure the PCB surface to time, EPA will confirm the use of concentrations of at least three of the validated new decontamination sol- surfaces using a standard wipe test to vents and publish the new solvents and establish a surface concentration to be validated decontamination procedures included in the standard operating pro- in the FEDERAL REGISTER. cedure. The surface levels of PCBs on (b) Any person may begin to use sol- the contaminated surfaces must be ≥20 vent validated in accordance with this μg/100 cm2. subpart at the time results are sub- (b) [Reserved] mitted to EPA.

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(c) Record all testing parameters and APPENDIX C TO SUBPART E—ASBESTOS MODEL experimental conditions from the suc- ACCREDITATION PLAN cessful validation study into a stand- APPENDIX D TO SUBPART E—TRANSPORT AND ard operating procedure (SOP) for ref- DISPOSAL OF ASBESTOS WASTE APPENDIX E TO SUBPART E—INTERIM METHOD erence whenever the decontamination OF THE DETERMINATION OF ASBESTOS IN procedure is used. Include in the SOP BULK INSULATION SAMPLES the identity of the soaking solvent, the length of time of the soak, and the Subpart F [Reserved] ratio of the soak solvent to contaminated surface area during the soaking Subpart G—Asbestos Worker Protection process. Also include in the SOP the 763.120 What is the purpose of this subpart? maximum concentration of PCBs in the 763.121 Does this subpart apply to me? spilled material and the identity of the 763.122 What does this subpart require me to spilled material, and/or the measured do? maximum surface concentration of the 763.123 May a State implement its own as- contaminated surface used in the vali- bestos worker protection plan? dation study. Record and keep the re- Subpart H [Reserved] sults of the validation study as an appendix to the SOP. Include in this ap- Subpart I—Prohibition of the Manufacture, pendix, the solvent used to make the Importation, Processing, and Distribu- spiking solution, the PCB concentration in Commerce of Certain Asbestos- tion of the spiking solution used to Containing Products; Labeling Require- contaminate the surfaces in the valida- ments tion study, and all of the validation study testing parameters and experi- 763.160 Scope. 763.163 Definitions. mental conditions. 763.165 Manufacture and importation prohi- [63 FR 35473, June 29, 1998, as amended at 72 bitions. FR 57241, Oct. 9, 2007; 74 FR 30235, June 25, 763.167 Processing prohibitions. 2009] 763.169 Distribution in commerce prohibitions. 763.171 Labeling requirements. PART 763—ASBESTOS 763.173 Exemptions. 763.175 Enforcement. Subparts A–D [Reserved] 763.176 Inspections. 763.178 Recordkeeping. Subpart E—Asbestos-Containing Materials 763.179 Confidential business information in Schools claims. Sec. AUTHORITY: 15 U.S.C. 2605, 2607(c), 2643, and 763.80 Scope and purpose. 2646. 763.83 Definitions. 763.84 General local education agency re- Subparts A–D [Reserved] sponsibilities. 763.85 Inspection and reinspections. 763.86 Sampling. Subpart E—Asbestos-Containing 763.87 Analysis. Materials in Schools 763.88 Assessment. 763.90 Response actions. SOURCE: 52 FR 41846, Oct. 30, 1987, unless 763.91 Operations and maintenance. otherwise noted. 763.92 Training and periodic surveillance. 763.93 Management plans. 763.94 Recordkeeping. § 763.80 Scope and purpose. 763.95 Warning labels. (a) This rule requires local education 763.97 Compliance and enforcement. agencies to identify friable and nonfri- 763.98 Waiver; delegation to State. able asbestos-containing material 763.99 Exclusions. (ACM) in public and private elemen- APPENDIX A TO SUBPART E—INTERIM TRANS- tary and secondary schools by visually MISSION ELECTRON MICROSCOPY ANALYT- inspecting school buildings for such ICAL METHODS—MANDATORY AND NON- MANDATORY—AND MANDATORY SECTION TO materials, sampling such materials if DETERMINE COMPLETION OF RESPONSE AC- they are not assumed to be ACM, and TIONS having samples analyzed by appro- APPENDIX B TO SUBPART E [RESERVED] priate techniques referred to in this rule. The rule requires local education 845

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agencies to submit management plans Asbestos means the asbestiform vari- to the Governor of their State by Octo- eties of: Chrysotile (serpentine); cro- ber 12, 1988, begin to implement the cidolite (riebeckite); amosite (cum- plans by July 9, 1989, and complete im- mingtonitegrunerite); anthophyllite; plementation of the plans in a timely tremolite; and actinolite. fashion. In addition, local education Asbestos-containing material (ACM) agencies are required to use persons when referring to school buildings who have been accredited to conduct means any material or product which inspections, reinspections, develop contains more than 1 percent asbestos. management plans, or perform re- Asbestos-containing building material sponse actions. The rule also includes (ACBM) means surfacing ACM, thermal recordkeeping requirements. Local system insulation ACM, or miscella- education agencies may contractually neous ACM that is found in or on inte- delegate their duties under this rule, rior structural members or other parts but they remain responsible for the of a school building. proper performance of those duties. Asbestos debris means pieces of ACBM Local education agencies are encour- that can be identified by color, texture, aged to consult with EPA Regional As- or composition, or means dust, if the bestos Coordinators, or if applicable, a dust is determined by an accredited in- State’s lead agency designated by the spector to be ACM. State Governor, for assistance in com- Damaged friable miscellaneous ACM plying with this rule. means friable miscellaneous ACM (b) Local education agencies must which has deteriorated or sustained provide for the transportation and dis- physical injury such that the internal posal of asbestos in accordance with structure (cohesion) of the material is EPA’s ‘‘Asbestos Waste Management inadequate or, if applicable, which has Guidance.’’ For convenience, applicable delaminated such that its bond to the sections of this guidance are reprinted substrate (adhesion) is inadequate or as Appendix D of this subpart. There which for any other reason lacks fiber are regulations in place, however, that cohesion or adhesion qualities. Such affect transportation and disposal of damage or deterioration may be illus- asbestos waste generated by this rule. trated by the separation of ACM into The transportation of asbestos waste is layers; separation of ACM from the covered by the Department of Trans- substrate; flaking, blistering, or crum- portation (49 CFR part 173, subpart J) bling of the ACM surface; water dam- and disposal is covered by the National age; significant or repeated water Emissions Standards for Hazardous Air stains, scrapes, gouges, mars or other Pollutants (NESHAP) (40 CFR part 61, signs of physical injury on the ACM. subpart M). Asbestos debris originating from the ACBM in question may also indicate § 763.83 Definitions. damage. For purposes of this subpart: Damaged friable surfacing ACM means Act means the Toxic Substances Con- friable surfacing ACM which has dete- trol Act (TSCA), 15 U.S.C. 2601, et seq. riorated or sustained physical injury Accessible when referring to ACM such that the internal structure (cohe- means that the material is subject to sion) of the material is inadequate or disturbance by school building occu- which has delaminated such that its pants or custodial or maintenance per- bond to the substrate (adhesion) is in- sonnel in the course of their normal ac- adequate, or which, for any other rea- tivities. son, lacks fiber cohesion or adhesion Accredited or accreditation when refer- qualities. Such damage or deteriora- ring to a person or laboratory means tion may be illustrated by the separa- that such person or laboratory is action of ACM into layers; separation of credited in accordance with section 206 ACM from the substrate; flaking, blis- of Title II of the Act. tering, or crumbling of the ACM sur- Air erosion means the passage of air face; water damage; significant or re- over friable ACBM which may result in peated water stains, scrapes, gouges, the release of asbestos fibers. mars or other signs of physical injury

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on the ACM. Asbestos debris origi- High-efficiency particulate air (HEPA) nating from the ACBM in question may refers to a filtering system capable of also indicate damage. trapping and retaining at least 99.97 Damaged or significantly damaged ther- percent of all monodispersed particles mal system insulation ACM means ther- 0.3 μm in diameter or larger. mal system insulation ACM on pipes, Homogeneous area means an area of boilers, tanks, ducts, and other ther- surfacing material, thermal system in- mal system insulation equipment sulation material, or miscellaneous where the insulation has lost its struc- material that is uniform in color and tural integrity, or its covering, in texture. whole or in part, is crushed, water- Local education agency means: stained, gouged, punctured, missing, or (1) Any local educational agency as not intact such that it is not able to defined in section 198 of the Elemen- contain fibers. Damage may be further tary and Secondary Education Act of illustrated by occasional punctures, 1965 (20 U.S.C. 3381). gouges or other signs of physical injury (2) The owner of any nonpublic, non- to ACM; occasional water damage on profit elementary, or secondary school the protective coverings/jackets; or ex- building. posed ACM ends or joints. Asbestos de- (3) The governing authority of any bris originating from the ACBM in school operated under the defense de- question may also indicate damage. pendent’s education system provided Encapsulation means the treatment of for under the Defense Dependents’ Edu- ACBM with a material that surrounds cation Act of 1978 (20 U.S.C. 921, et or embeds asbestos fibers in an adhe- seq.). sive matrix to prevent the release of fi- Miscellaneous ACM means miscella- bers, as the encapsulant creates a neous material that is ACM in a school membrane over the surface (bridging building. Miscellaneous material means interior encapsulant) or penetrates the mate- building material on structural compo- rial and binds its components together nents, structural members or fixtures, (penetrating encapsulant). such as floor and ceiling tiles, and does Enclosure means an airtight, imper- not include surfacing material or ther- meable, permanent barrier around mal system insulation. ACBM to prevent the release of asbes- Nonfriable means material in a school tos fibers into the air. building which when dry may not be Fiber release episode means any un- crumbled, pulverized, or reduced to controlled or unintentional disturb- powder by hand pressure. ance of ACBM resulting in visible emis- Operations and maintenance program sion. means a program of work practices to Friable when referring to material in maintain friable ACBM in good condi- a school building means that the mate- tion, ensure clean up of asbestos fibers rial, when dry, may be crumbled, pul- previously released, and prevent fur- verized, or reduced to powder by hand ther release by minimizing and con- pressure, and includes previously non- trolling friable ACBM disturbance or friable material after such previously damage. nonfriable material becomes damaged Potential damage means cir- to the extent that when dry it may be cumstances in which: crumbled, pulverized, or reduced to (1) Friable ACBM is in an area regu- powder by hand pressure. larly used by building occupants, in- Functional space means a room, group cluding maintenance personnel, in the of rooms, or homogeneous area (includ- course of their normal activities. ing crawl spaces or the space between a (2) There are indications that there is dropped ceiling and the floor or roof a reasonable likelihood that the mate- deck above), such as classroom(s), a rial or its covering will become dam- cafeteria, gymnasium, hallway(s), des- aged, deteriorated, or delaminated due ignated by a person accredited to pre- to factors such as changes in building pare management plans, design abate- use, changes in operations and mainte- ment projects, or conduct response ac- nance practices, changes in occupancy, tions. or recurrent damage.

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Potential significant damage means or recreational activities for an aca- circumstances in which: demic course in physical education. (1) Friable ACBM is in an area regu- (3) Any other facility used for the in- larly used by building occupants, instruction or housing of students or for cluding maintenance personnel, in the the administration of educational or course of their normal activities. research programs. (2) There are indications that there is (4) Any maintenance, storage, or util- a reasonable likelihood that the mate- ity facility, including any hallway, es- rial or its covering will become signifi- sential to the operation of any facility cantly damaged, deteriorated, or described in this definition of ‘‘school delaminated due to factors such as building’’ under paragraphs (1), (2), or changes in building use, changes in op- (3). erations and maintenance practices, (5) Any portico or covered exterior changes in occupancy, or recurrent hallway or walkway. damage. (6) Any exterior portion of a mechan- (3) The material is subject to major ical system used to condition interior or continuing disturbance, due to fac- space. tors including, but not limited to, ac- Significantly damaged friable miscella- cessibility or, under certain cir- neous ACM means damaged friable mis- cumstances, vibration or air erosion. cellaneous ACM where the damage is Preventive measures means actions extensive and severe. taken to reduce disturbance of ACBM Significantly damaged friable surfacing or otherwise eliminate the reasonable ACM means damaged friable surfacing likelihood of the material’s becoming ACM in a functional space where the damaged or significantly damaged. damage is extensive and severe. Removal means the taking out or the State means a State, the District of stripping of substantially all ACBM Columbia, the Commonwealth of Puer- from a damaged area, a functional to Rico, Guam, American Samoa, the space, or a homogeneous area in a Northern Marianas, the Trust Terri- school building. tory of the Pacific Islands, and the Vir- Repair means returning damaged gin Islands. ACBM to an undamaged condition or to Surfacing ACM means surfacing mate- an intact state so as to prevent fiber rial that is ACM. release. Surfacing material means material in Response action means a method, in- a school building that is sprayed-on, cluding removal, encapsulation, enclo- troweled-on, or otherwise applied to sure, repair, operations and mainte- surfaces, such as acoustical plaster on nance, that protects human health and ceilings and fireproofing materials on the environment from friable ACBM. structural members, or other materials Routine maintenance area means an on surfaces for acoustical, fireproofing, area, such as a boiler room or mechan- or other purposes. ical room, that is not normally fre- Thermal system insulation means ma- quented by students and in which terial in a school building applied to maintenance employees or contract pipes, fittings, boilers, breeching, workers regularly conduct mainte- tanks, ducts, or other interior struc- nance activities. tural components to prevent heat loss School means any elementary or sec- or gain, or water condensation, or for ondary school as defined in section 198 other purposes. of the Elementary and Secondary Edu- Thermal system insulation ACM means cation Act of 1965 (20 U.S.C. 2854). thermal system insulation that is School building means: ACM. (1) Any structure suitable for use as a Vibration means the periodic motion classroom, including a school facility of friable ACBM which may result in such as a laboratory, library, school the release of asbestos fibers. eating facility, or facility used for the preparation of food. § 763.84 General local education agen- (2) Any gymnasium or other facility cy responsibilities. which is specially designed for athletic Each local education agency shall:

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(a) Ensure that the activities of any portation and the U.S. Environmental persons who perform inspections, re- Protection Agency. inspections, and periodic surveillance, (h) Consider whether any conflict of develop and update management plans, interest may arise from the inter- and develop and implement response relationship among accredited per- actions, including operations and sonnel and whether that should influ- maintenance, are carried out in accord- ence the selection of accredited per- ance with subpart E of this part. sonnel to perform activities under this (b) Ensure that all custodial and subpart. maintenance employees are properly trained as required by this subpart E § 763.85 Inspection and reinspections. and other applicable Federal and/or (a) Inspection. (1) Except as provided State regulations (e.g., the Occupa- in paragraph (a)(2) of this section, be- tional Safety and Health Administra- fore October 12, 1988, local education tion asbestos standard for construc- agencies shall inspect each school tion, the EPA worker protection rule, building that they lease, own, or other- or applicable State regulations). wise use as a school building to iden- (c) Ensure that workers and building tify all locations of friable and nonfri- occupants, or their legal guardians, are able ACBM. informed at least once each school year (2) Any building leased or acquired on about inspections, response actions, or after October 12, 1988, that is to be and post-response action activities, in- used as a school building shall be including periodic reinspection and sur- spected as described under paragraphs veillance activities that are planned or (a) (3) and (4) of this section prior to in progress. use as a school building. In the event (d) Ensure that short-term workers that emergency use of an uninspected (e.g., telephone repair workers, utility building as a school building is neces- workers, or exterminators) who may sitated, such buildings shall be in- come in contact with asbestos in a spected within 30 days after commence- school are provided information re- ment of such use. garding the locations of ACBM and sus- (3) Each inspection shall be made by pected ACBM assumed to be ACM. an accredited inspector. (e) Ensure that warning labels are (4) For each area of a school building, posted in accordance with § 763.95. except as excluded under § 763.99, each (f) Ensure that management plans person performing an inspection shall: are available for inspection and notifi- (i) Visually inspect the area to iden- cation of such availability has been tify the locations of all suspected provided as specified in the manage- ACBM. ment plan under § 763.93(g). (ii) Touch all suspected ACBM to determine whether they are friable. (g)(1) Designate a person to ensure (iii) Identify all homogeneous areas that requirements under this section of friable suspected ACBM and all ho- are properly implemented. mogeneous areas of nonfriable sus- (2) Ensure that the designated person pected ACBM. receives adequate training to perform (iv) Assume that some or all of the duties assigned under this section. homogeneous areas are ACM, and, for Such training shall provide, as nec- each homogeneous area that is not as- essary, basic knowledge of: sumed to be ACM, collect and submit (i) Health effects of asbestos. for analysis bulk samples under (ii) Detection, identification, and as- §§ 763.86 and 763.87. sessment of ACM. (v) Assess, under § 763.88, friable ma- (iii) Options for controlling ACBM. terial in areas where samples are col- (iv) Asbestos management programs. lected, friable material in areas that (v) Relevant Federal and State regu- are assumed to be ACBM, and friable lations concerning asbestos, including ACBM identified during a previous in- those in this subpart E and those of the spection. Occupational Safety and Health Ad- (vi) Record the following and submit ministration, U.S. Department of to the person designated under § 763.84 Labor, the U.S. Department of Trans- a copy of such record for inclusion in

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the management plan within 30 days of since the last inspection or reinspec- the inspection: tion. (A) An inspection report with the (iv) For each homogeneous area of date of the inspection signed by each newly friable material that is already accredited person making the inspec- assumed to be ACBM, bulk samples tion, State of accreditation, and if ap- may be collected and submitted for plicable, his or her accreditation num- analysis in accordance with §§ 763.86 ber. and 763.87. (B) An inventory of the locations of (v) Assess, under § 763.88, the condi- the homogeneous areas where samples tion of the newly friable material in are collected, exact location where areas where samples are collected, and each bulk sample is collected, dates newly friable materials in areas that that samples are collected, homo- are assumed to be ACBM. geneous areas where friable suspected (vi) Reassess, under § 763.88, the con- ACBM is assumed to be ACM, and ho- dition of friable known or assumed mogeneous areas where nonfriable sus- ACBM previously identified. pected ACBM is assumed to be ACM. (vii) Record the following and submit (C) A description of the manner used to the person designated under § 763.84 to determine sampling locations, the a copy of such record for inclusion in name and signature of each accredited the management plan within 30 days of inspector who collected the samples, the reinspection: State of accreditation, and, if applica- (A) The date of the reinspection, the ble, his or her accreditation number. name and signature of the person mak- (D) A list of whether the homo- ing the reinspection, State of accredi- geneous areas identified under para- tation, and if applicable, his or her ac- graph (a)(4)(vi)(B) of this section, are creditation number, and any changes surfacing material, thermal system in- in the condition of known or assumed sulation, or miscellaneous material. ACBM. (E) Assessments made of friable ma- (B) The exact locations where sam- terial, the name and signature of each ples are collected during the reinspec- accredited inspector making the as- tion, a description of the manner used sessment, State of accreditation, and if to determine sampling locations, the applicable, his or her accreditation name and signature of each accredited number. inspector who collected the samples, (b) Reinspection. (1) At least once State of accreditation, and, if applica- every 3 years after a management plan ble, his or her accreditation number. is in effect, each local education agen- (C) Any assessments or reassess- cy shall conduct a reinspection of all ments made of friable material, the friable and nonfriable known or as- name and signature of the accredited sumed ACBM in each school building inspector making the assessments, that they lease, own, or otherwise use State of accreditation, and if applica- as a school building. ble, his or her accreditation number. (2) Each inspection shall be made by (c) General. Thermal system insula- an accredited inspector. tion that has retained its structural in- (3) For each area of a school building, tegrity and that has an undamaged each person performing a reinspection protective jacket or wrap that prevents shall: fiber release shall be treated as nonfri- (i) Visually reinspect, and reassess, able and therefore is subject only to under § 763.88, the condition of all fri- periodic surveillance and preventive able known or assumed ACBM. measures as necessary. (ii) Visually inspect material that was previously considered nonfriable § 763.86 Sampling. ACBM and touch the material to deter- (a) Surfacing material. An accredited mine whether it has become friable inspector shall collect, in a statis- since the last inspection or reinspec- tically random manner that is rep- tion. resentative of the homogeneous area, (iii) Identify any homogeneous areas bulk samples from each homogeneous with material that has become friable area of friable surfacing material that

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is not assumed to be ACM, and shall suspected ACBM that is not assumed to collect the samples as follows: be ACM. (1) At least three bulk samples shall be collected from each homogeneous § 763.87 Analysis. area that is 1,000 ft2 or less, except as (a) Local education agencies shall provided in § 763.87(c)(2). have bulk samples, collected under (2) At least five bulk samples shall be § 763.86 and submitted for analysis, ana- collected from each homogeneous area lyzed for asbestos using laboratories that is greater than 1,000 ft2 but less accredited by the National Bureau of than or equal to 5,000 ft2, except as pro- Standards (NBS). Local education vided in § 763.87(c)(2). agencies shall use laboratories which (3) At least seven bulk samples shall have received interim accreditation for be collected from each homogeneous polarized light microscopy (PLM) anal- area that is greater than 5,000 ft2, ex- ysis under the EPA Interim Asbestos cept as provided in § 763.87(c)(2). Bulk Sample Analysis Quality Assur- (b) Thermal system insulation. (1) Ex- ance Program until the NBS PLM lab- cept as provided in paragraphs (b) (2) oratory accreditation program for PLM through (4) of this section and is operational. § 763.87(c), an accredited inspector shall (b) Bulk samples shall not be compos- collect, in a randomly distributed man- ited for analysis and shall be analyzed ner, at least three bulk samples from for asbestos content by PLM, using the each homogeneous area of thermal sys- ‘‘Interim Method for the Determina- tem insulation that is not assumed to tion of Asbestos in Bulk Insulation be ACM. Samples’’ found at appendix E to sub- (2) Collect at least one bulk sample part E of this part. from each homogeneous area of (c)(1) A homogeneous area is consid- patched thermal system insulation ered not to contain ACM only if the re- that is not assumed to be ACM if the sults of all samples required to be col- patched section is less than 6 linear or lected from the area show asbestos in square feet. amounts of 1 percent or less. (3) In a manner sufficient to deter- (2) A homogeneous area shall be de- mine whether the material is ACM or termined to contain ACM based on a not ACM, collect bulk samples from finding that the results of at least one each insulated mechanical system that sample collected from that area shows is not assumed to be ACM where ce- that asbestos is present in an amount ment or plaster is used on fittings such greater than 1 percent. as tees, elbows, or valves, except as (d) The name and address of each lab- provided under § 763.87(c)(2). oratory performing an analysis, the (4) Bulk samples are not required to date of analysis, and the name and sig- be collected from any homogeneous nature of the person performing the area where the accredited inspector has analysis shall be submitted to the per- determined that the thermal system son designated under § 763.84 for inclu- insulation is fiberglass, foam glass, sion into the management plan within rubber, or other non-ACBM. 30 days of the analysis. (c) Miscellaneous material. In a man- [52 FR 41846, Oct. 30, 1987, as amended at 60 ner sufficient to determine whether FR 31922, June 19, 1995] material is ACM or not ACM, an accredited inspector shall collect bulk § 763.88 Assessment. samples from each homogeneous area (a)(1) For each inspection and rein- of friable miscellaneous material that spection conducted under § 763.85 (a) is not assumed to be ACM. and (c) and previous inspections speci- (d) Nonfriable suspected ACBM. If any fied under § 763.99, the local education homogeneous area of nonfriable sus- agency shall have an accredited inspec- pected ACBM is not assumed to be tor provide a written assessment of all ACM, then an accredited inspector friable known or assumed ACBM in the shall collect, in a manner sufficient to school building. determine whether the material is (2) Each accredited inspector pro- ACM or not ACM, bulk samples from viding a written assessment shall sign the homogeneous area of nonfriable and date the assessment, provide his or

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her State of accreditation, and if appli- tivities in order to recommend in writ- cable, accreditation number, and sub- ing to the local education agency ap- mit a copy of the assessment to the propriate response actions. The accred- person designated under § 763.84 for in- ited person shall sign and date the rec- clusion in the management plan within ommendation, provide his or her State 30 days of the assessment. of accreditation, and, if applicable, pro- (b) The inspector shall classify and vide his or her accreditation number, give reasons in the written assessment and submit a copy of the recommenda- for classifying the ACBM and suspected tion to the person designated under ACBM assumed to be ACM in the § 763.84 for inclusion in the manage- school building into one of the fol- ment plan. lowing categories: (1) Damaged or significantly dam- § 763.90 Response actions. aged thermal system insulation ACM. (a) The local education agency shall (2) Damaged friable surfacing ACM. select and implement in a timely man- (3) Significantly damaged friable sur- ner the appropriate response actions in facing ACM. this section consistent with the assess- (4) Damaged or significantly dam- ment conducted in § 763.88. The re- aged friable miscellaneous ACM. sponse actions selected shall be suffi- (5) ACBM with potential for damage. cient to protect human health and the (6) ACBM with potential for signifi- environment. The local education cant damage. agency may then select, from the re- (7) Any remaining friable ACBM or sponse actions which protect human friable suspected ACBM. health and the environment, that ac- (c) Assessment may include the fol- tion which is the least burdensome lowing considerations: method. Nothing in this section shall (1) Location and the amount of the be construed to prohibit removal of material, both in total quantity and as ACBM from a school building at any a percentage of the functional space. time, should removal be the preferred (2) Condition of the material, speci- response action of the local education fying: agency. (i) Type of damage or significant damage (e.g., flaking, blistering, water (b) If damaged or significantly dam- damage, or other signs of physical aged thermal system insulation ACM is damage). present in a building, the local edu- (ii) Severity of damage (e.g., major cation agency shall: flaking, severely torn jackets, as op- (1) At least repair the damaged area. posed to occasional flaking, minor (2) Remove the damaged material if tears to jackets). it is not feasible, due to technological (iii) Extent or spread of damage over factors, to repair the damage. large areas or large percentages of the (3) Maintain all thermal system insu- homogeneous area. lation ACM and its covering in an in- (3) Whether the material is acces- tact state and undamaged condition. sible. (c)(1) If damaged friable surfacing (4) The material’s potential for dis- ACM or damaged friable miscellaneous turbance. ACM is present in a building, the local (5) Known or suspected causes of education agency shall select from damage or significant damage (e.g., air among the following response actions: erosion, vandalism, vibration, water). encapsulation, enclosure, removal, or (6) Preventive measures which might repair of the damaged material. eliminate the reasonable likelihood of (2) In selecting the response action undamaged ACM from becoming sig- from among those which meet the defi- nificantly damaged. nitional standards in § 763.83, the local (d) The local education agency shall education agency shall determine select a person accredited to develop which of these response actions pro- management plans to review the re- tects human health and the environ- sults of each inspection, reinspection, ment. For purposes of determining and assessment for the school building which of these response actions are the and to conduct any other necessary ac- least burdensome, the local education

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agency may then consider local cir- tection and work practice require- cumstances, including occupancy and ments under 29 CFR 1926.58 (Occupa- use patterns within the school build- tional Safety and Health Administra- ing, and its economic concerns, includ- tion (OSHA) asbestos worker protec- ing short- and long-term costs. tion standards for construction), 40 (d) If significantly damaged friable CFR part 763, subpart G (EPA asbestos surfacing ACM or significantly dam- worker protection standards for public aged friable miscellaneous ACM is employees), and 40 CFR part 61, sub- present in a building the local edu- part M (National Emission Standards cation agency shall: for Hazardous Air Pollutants—Asbes- (1) Immediately isolate the func- tos). tional space and restrict access, unless (i) Completion of response actions. (1) isolation is not necessary to protect At the conclusion of any action to re- human health and the environment. move, encapsulate, or enclose ACBM or (2) Remove the material in the func- material assumed to be ACBM, a per- tional space or, depending upon wheth- son designated by the local education er enclosure or encapsulation would be agency shall visually inspect each sufficient to protect human health and functional space where such action was the environment, enclose or encap- conducted to determine whether the sulate. action has been properly completed. (e) If any friable surfacing ACM, (2)(i) A person designated by the local thermal system insulation ACM, or fri- education agency shall collect air sam- able miscellaneous ACM that has po- ples using aggressive sampling as de- tential for damage is present in a scribed in appendix A to this subpart E building, the local education agency to monitor air for clearance after each shall at least implement an operations removal, encapsulation, and enclosure and maintenance (O&M) program, as project involving ACBM, except for described under § 763.91. projects that are of small-scale, short- (f) If any friable surfacing ACM, ther- duration. mal system insulation ACM, or friable (ii) Local education agencies shall miscellaneous ACM that has potential have air samples collected under this for significant damage is present in a section analyzed for asbestos using lab- building, the local education agency oratories accredited by the National shall: Bureau of Standards to conduct such (1) Implement an O&M program, as analysis using transmission electron described under § 763.91. microscopy (TEM) or, under cir- (2) Institute preventive measures ap- cumstances permitted in this section, propriate to eliminate the reasonable laboratories enrolled in the American likelihood that the ACM or its covering Industrial Hygiene Association Pro- will become significantly damaged, deficiency Analytical Testing Program teriorated, or delaminated. for phase contrast microscopy (PCM). (3) Remove the material as soon as (iii) Until the National Bureau of possible if appropriate preventive Standards TEM laboratory accredita- measures cannot be effectively imple- tion program is operational, local edu- mented, or unless other response ac- cational agencies shall use laboratories tions are determined to protect human that use the protocol described in ap- health and the environment. Imme- pendix A to subpart E of this part. diately isolate the area and restrict ac- (3) Except as provided in paragraphs cess if necessary to avoid an imminent (i)(4), and (i)(5), of this section, an ac- and substantial endangerment to tion to remove, encapsulate, or enclose human health or the environment. ACBM shall be considered complete (g) Response actions including re- when the average concentration of as- moval, encapsulation, enclosure, or re- bestos of five air samples collected pair, other than small-scale, short-du- within the affected functional space ration repairs, shall be designed and and analyzed by the TEM method in conducted by persons accredited to de- appendix A of this subpart E, is not sign and conduct response actions. statistically significantly different, as (h) The requirements of this subpart determined by the Z-test calculation E in no way supersede the worker pro- found in appendix A of this subpart E,

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from the average asbestos concentra- inspection at the Non-Confidential In- tion of five air samples collected at the formation Center (NCIC) (7407), Office same time outside the affected func- of Pollution Prevention and Toxics, tional space and analyzed in the same U.S. Environmental Protection Agen- manner, and the average asbestos con- cy, Room B–607 NEM, 401 M St., SW., centration of the three field blanks de- Washington, DC 20460, between the scribed in appendix A of this subpart E hours of 12 p.m. and 4 p.m. weekdays is below the filter background level, as excluding legal holidays or at the Na- defined in appendix A of this subpart E, tional Archives and Records Adminis- of 70 structures per square millimeter tration (NARA). For information on (70 s/mm2). the availability of this material at (4) An action may also be considered NARA, call 202–741–6030, or go to: http:// complete if the volume of air drawn for www.archives.gov/federallregister/ each of the five samples collected with- codeloflfederallregulations/ in the affected functional space is ibrllocations.html. This incorporation equal to or greater than 1,199 L of air by reference was approved by the Di- for a 25 mm filter or equal to or greater rector of the Federal Register in ac- than 2,799 L of air for a 37 mm filter, cordance with 5 U.S.C. 552(a) and 1 CFR and the average concentration of asbes- part 51. The method is incorporated as tos as analyzed by the TEM method in it exists on the effective date of this appendix A of this subpart E, for the rule, and a notice of any change to the five air samples does not exceed the fil- method will be published in the FED- ter background level, as defined in ap- ERAL REGISTER. pendix A, of 70 structures per square (6) To determine the amount of 2 millimeter (70 s/mm ). If the average ACBM affected under paragraph (i)(5) concentration of asbestos of the five of this section, the local education air samples within the affected func- agency shall add the total square or 2 tional space exceeds 70 s/mm , or if the linear footage of ACBM within the con- volume of air in each of the samples is tainment barriers used to isolate the less than 1,199 L of air for a 25 mm fil- functional space for the action to re- ter or less than 2,799 L of air for a 37 move, encapsulate, or enclose the mm filter, the action shall be consid- ACBM. Contiguous portions of material ered complete only when the require- subject to such action conducted con- ments of paragraph (i)(3) or (i)(5), of currently or at approximately the this section are met. same time within the same school (5) At any time, a local education building shall not be separated to qual- agency may analyze air monitoring ify under paragraph (i)(5), of this sec- samples collected for clearance pur- tion. poses by phase contrast microscopy (PCM) to confirm completion of re- [52 FR 41846, Oct. 30, 1987, as amended at 53 moval, encapsulation, or enclosure of FR 12525, Apr. 15, 1988; 60 FR 31922, June 19, ACBM that is greater than small-scale, 1995; 60 FR 34465, July 3, 1995; 69 FR 18803, short-duration and less than or equal Apr. 9, 2004] to 160 square feet or 260 linear feet. The action shall be considered complete § 763.91 Operations and maintenance. when the results of samples collected (a) Applicability. The local education in the affected functional space and agency shall implement an operations, analyzed by phase contrast microscopy maintenance, and repair (O&M) pro- using the National Institute for Occu- gram under this section whenever any pational Safety and Health (NIOSH) friable ACBM is present or assumed to Method 7400 entitled ‘‘Fibers’’ pub- be present in a building that it leases, lished in the NIOSH Manual of Analyt- owns, or otherwise uses as a school ical Methods, 3rd Edition, Second Sup- building. Any material identified as plement, August 1987, show that the nonfriable ACBM or nonfriable as- concentration of fibers for each of the sumed ACBM must be treated as friable five samples is less than or equal to a ACBM for purposes of this section limit of quantitation for PCM (0.01 fi- when the material is about to become bers per cubic centimeter (0.01 f/cm3) of friable as a result of activities per- air). The method is available for public formed in the school building.

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(b) Worker protection. Local education (6) Place the asbestos debris and agencies must comply with either the other cleaning materials in a sealed, OSHA Asbestos Construction Standard leak-tight container. at 29 CFR 1926.1101, or the Asbestos (e) Maintenance activities other than Worker Protection Rule at 40 CFR small-scale, short-duration. The response 763.120, whichever is applicable. action for any maintenance activities (c) Cleaning—(1) Initial cleaning. Un- disturbing friable ACBM, other than less the building has been cleaned small-scale, short-duration mainte- using equivalent methods within the nance activities, shall be designed by previous 6 months, all areas of a school persons accredited to design response building where friable ACBM, damaged actions and conducted by persons ac- or significantly damaged thermal sys- credited to conduct response actions. tem insulation ACM, or friable sus- (f) Fiber release episodes—(1) Minor pected ACBM assumed to be ACM are The local education present shall be cleaned at least once fiber release episode. after the completion of the inspection agency shall ensure that the proce- required by § 763.85(a) and before the dures described below are followed in initiation of any response action, other the event of a minor fiber release epi- than O&M activities or repair, accord- sode (i.e., the falling or dislodging of 3 ing to the following procedures: square or linear feet or less of friable (i) HEPA-vacuum or steam-clean all ACBM): 5 carpets. (i) Thoroughly saturate the debris (ii) HEPA-vacuum or wet-clean all using wet methods. other floors and all other horizontal (ii) Clean the area, as described in surfaces. paragraph (e) of this section. (iii) Dispose of all debris, filters, (iii) Place the asbestos debris in a mopheads, and cloths in sealed, leak- sealed, leak-tight container. tight containers. (iv) Repair the area of damaged ACM (2) Additional cleaning. The accredited with materials such as asbestos-free management planner shall make a spackling, plaster, cement, or insula- written recommendation to the local tion, or seal with latex paint or an education agency whether additional encapsulant, or immediately have the cleaning is needed, and if so, the meth- appropriate response action imple- ods and frequency of such cleaning. mented as required by § 763.90. (d) Operations and maintenance activi- (2) Major fiber release episode. The ties. The local education agency shall local education agency shall ensure ensure that the procedures described that the procedures described below are below to protect building occupants followed in the event of a major fiber shall be followed for any operations release episode (i.e., the falling or dis- and maintenance activities disturbing lodging of more than 3 square or linear friable ACBM: feet of friable ACBM): (1) Restrict entry into the area by (i) Restrict entry into the area and persons other than those necessary to post signs to prevent entry into the perform the maintenance project, ei- area by persons other than those nec- ther by physically isolating the area or essary to perform the response action. by scheduling. (ii) Shut off or temporarily modify (2) Post signs to prevent entry by un- the air-handling system to prevent the authorized persons. distribution of fibers to other areas in (3) Shut off or temporarily modify the building. the air-handling system and restrict (iii) The response action for any other sources of air movement. major fiber release episode must be de- (4) Use work practices or other con- signed by persons accredited to design trols, such as, wet methods, protective clothing, HEPA-vacuums, mini-enclo- response actions and conducted by per- sures, glove bags, as necessary to in- sons accredited to conduct response ac- hibit the spread of any released fibers. tions. (5) Clean all fixtures or other compo- [52 FR 41846, Oct. 30, 1987, as amended at 65 nents in the immediate work area. FR 69216, Nov. 15, 2000]

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§ 763.92 Training and periodic surveil- (iii) The provisions of this section lance. and § 763.91, Appendices A, C, and D of (a) Training. (1) The local education this subpart E of this part, EPA regulations contained in 40 CFR part 763, sub- agency shall ensure, prior to the imple- part G, and in 40 CFR part 61, subpart mentation of the O&M provisions of M, and OSHA regulations contained in the management plan, that all mem- 29 CFR 1926.58. bers of its maintenance and custodial (iv) Hands-on training in the use of staff (custodians, electricians, heating/ respiratory protection, other personal air conditioning engineers, plumbers, protection measures, and good work etc.) who may work in a building that practices. contains ACBM receive awareness (3) Local education agency mainte- training of at least 2 hours, whether or nance and custodial staff who have at- not they are required to work with tended EPA-approved asbestos training ACBM. New custodial and maintenance or received equivalent training for employees shall be trained within 60 O&M and periodic surveillance activi- days after commencement of employ- ties involving asbestos shall be consid- ment. Training shall include, but not ered trained for the purposes of this be limited to: section. (i) Information regarding asbestos (b) Periodic surveillance. (1) At least and its various uses and forms. once every 6 months after a manage- (ii) Information on the health effects ment plan is in effect, each local edu- associated with asbestos exposure. cation agency shall conduct periodic (iii) Locations of ACBM identified surveillance in each building that it throughout each school building in leases, owns, or otherwise uses as a which they work. school building that contains ACBM or (iv) Recognition of damage, deterio- is assumed to contain ACBM. ration, and delamination of ACBM. (2) Each person performing periodic (v) Name and telephone number of surveillance shall: the person designated to carry out gen- (i) Visually inspect all areas that are eral local education agency respon- identified in the management plan as sibilities under § 763.84 and the avail- ACBM or assumed ACBM. ability and location of the manage- (ii) Record the date of the surveil- ment plan. lance, his or her name, and any (2) The local education agency shall changes in the condition of the mate- ensure that all members of its mainte- rials. nance and custodial staff who conduct (iii) Submit to the person designated any activities that will result in the to carry out general local education disturbance of ACBM shall receive agency responsibilities under § 763.84 a training described in paragraph (a)(1) copy of such record for inclusion in the of this section and 14 hours of addi- management plan. tional training. Additional training [52 FR 41846, Oct. 30, 1987, as amended at 60 shall include, but not be limited to: FR 34465, July 3, 1995; 65 FR 69216, Nov. 15, (i) Descriptions of the proper meth- 2000] ods of handling ACBM. (ii) Information on the use of res- § 763.93 Management plans. piratory protection as contained in the (a)(1) On or before October 12, 1988, EPA/NIOSH Guide to Respiratory Protec- each local education agency shall de- tion for the Asbestos Abatement Industry, velop an asbestos management plan for September 1986 (EPA 560/OPPTS–86– each school, including all buildings 001), available from the Director, Envi- that they lease, own, or otherwise use ronmental Assistance Division (7408), as school buildings, and submit the Office of Pollution Prevention and plan to an Agency designated by the Toxics, U.S. Environmental Protection Governor of the State in which the Agency, Room E–543B, 1200 Pennsyl- local education agency is located. The vania Ave., NW., Washington, DC 20460, plan may be submitted in stages that Telephone: (202) 554–1404, TDD: (202) cover a portion of the school buildings 544–0551 and other personal protection under the authority of the local edu- measures. cation agency.

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(2) If a building to be used as part of identifies clearly each location and ap- a school is leased or otherwise acquired proximate square or linear footage of after October 12, 1988, the local edu- any homogeneous or sampling area cation agency shall include the new where material was sampled for ACM, building in the management plan for and, if possible, the exact locations the school prior to its use as a school where bulk samples were collected, and building. The revised portions of the the dates of collection. management plan shall be submitted to (iii) A copy of the analyses of any the Agency designated by the Gov- bulk samples, dates of analyses, and a ernor. copy of any other laboratory reports (3) If a local education agency begins pertaining to the analyses. to use a building as a school after Octo- (iv) A description of any response ac- ber 12, 1988, the local education agency tions or preventive measures taken to shall submit a management plan for reduce asbestos exposure, including if the school to the Agency designated by the Governor prior to its use as a possible, the names and addresses of all school. contractors involved, start and comple- (b) On or before October 17, 1987, the tion dates of the work, and results of Governor of each State shall notify any air samples analyzed during and local education agencies in the State upon completion of the work. regarding where to submit their man- (v) A description of assessments, re- agement plans. States may establish quired to be made under § 763.88, of ma- administrative procedures for review- terial that was identified before De- ing management plans. If the Governor cember 14, 1987, as friable ACBM or fri- does not disapprove a management able suspected ACBM assumed to be plan within 90 days after receipt of the ACM, and the name and signature, plan, the local education agency shall State of accreditation, and if applica- implement the plan. ble, accreditation number of each ac- (c) Each local education agency must credited person making the assess- begin implementation of its manage- ments. ment plan on or before July 9, 1989, and (3) For each inspection and reinspec- complete implementation in a timely tion conducted under § 763.85: fashion. (i) The date of the inspection or rein- (d) Each local education agency shall spection and the name and signature, maintain and update its management State of accreditation and, if applica- plan to keep it current with ongoing ble, the accreditation number of each operations and maintenance, periodic accredited inspector performing the in- surveillance, inspection, reinspection, spection or reinspection. and response action activities. All pro- (ii) A blueprint, diagram, or written visions required to be included in the description of each school building that management plan under this section identifies clearly each location and ap- shall be retained as part of the man- proximate square or linear footage of agement plan, as well as any informa- homogeneous areas where material was tion that has been revised to bring the plan up-to-date. sampled for ACM, the exact location (e) The management plan shall be de- where each bulk sample was collected, veloped by an accredited management date of collection, homogeneous areas planner and shall include: where friable suspected ACBM is as- (1) A list of the name and address of sumed to be ACM, and where nonfriable each school building and whether the suspected ACBM is assumed to be ACM. school building contains friable ACBM, (iii) A description of the manner used nonfriable ACBM, and friable and non- to determine sampling locations, and friable suspected ACBM assumed to be the name and signature of each accred- ACM. ited inspector collecting samples, the (2) For each inspection conducted be- State of accreditation, and if applica- fore the December 14, 1987: ble, his or her accreditation number. (i) The date of the inspection. (iv) A copy of the analyses of any (ii) A blueprint, diagram, or written bulk samples collected and analyzed, description of each school building that the name and address of any laboratory

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that analyzed bulk samples, a state- any ACBM or suspected ACBM assumed ment that the laboratory meets the ap- to be ACM which remains in the school plicable requirements of § 763.87(a) the once response actions are undertaken date of analysis, and the name and sig- pursuant to § 763.90. This description nature of the person performing the shall be updated as response actions analysis. are completed. (v) A description of assessments, re- (9) A plan for reinspection under quired to be made under § 763.88, of all § 763.85, a plan for operations and main- ACBM and suspected ACBM assumed to tenance activities under § 763.91, and a be ACM, and the name, signature, plan for periodic surveillance under State of accreditation, and if applica- § 763.92, a description of the rec- ble, accreditation number of each ac- ommendation made by the manage- credited person making the assessment planner regarding additional ments. cleaning under § 763.91(c)(2) as part of (4) The name, address, and telephone an operations and maintenance pro- number of the person designated under gram, and the response of the local § 763.84 to ensure that the duties of the education agency to that recommenda- local education agency are carried out, tion. and the course name, and dates and (10) A description of steps taken to hours of training taken by that person inform workers and building occu- to carry out the duties. pants, or their legal guardians, about (5) The recommendations made to the inspections, reinspections, response ac- local education agency regarding re- tions, and post-response action activi- sponse actions, under § 763.88(d), the ties, including periodic reinspection name, signature, State of accreditation and surveillance activities that are of each person making the rec- planned or in progress. ommendations, and if applicable, his or (11) An evaluation of the resources her accreditation number. needed to complete response actions (6) A detailed description of preven- successfully and carry out reinspec- tive measures and response actions to tion, operations and maintenance ac- be taken, including methods to be used, tivities, periodic surveillance and for any friable ACBM, the locations training. where such measures and action will be (12) With respect to each consultant taken, reasons for selecting the re- who contributed to the management sponse action or preventive measure, plan, the name of the consultant and and a schedule for beginning and com- one of the following statements: pleting each preventive measure and (i) If the State has adopted a con- response action. tractor accreditation plan under sec- (7) With respect to the person or per- tion 206(b) of Title II of the Act, a sons who inspected for ACBM and who statement that the consultant is ac- will design or carry out response accredited under such plan. tions, except for operations and main- (ii) A statement that the contractor tenance, with respect to the ACBM, is accredited by another State which one of the following statements: has adopted a contractor accreditation (i) If the State has adopted a con- plan under section 206(b) of Title II of tractor accreditation program under the Act, or is accredited by an EPA-ap- section 206(b) of Title II of the Act, a proved course developed under section statement that the person(s) is accred- 206(c) of Title II of the Act. ited under such plan. (f) A local education agency may re- (ii) A statement that the local edu- quire each management plan to con- cation agency used (or will use) persons tain a statement signed by an accred- who have been accredited by another ited management plan developer that State which has adopted a contractor such person has prepared or assisted in accreditation plan under section 206(b) the preparation of such plan or has re- of Title II of the Act or is accredited by viewed such plan, and that such plan is an EPA-approved course under section in compliance with this subpart E. 206(c) of Title II of the Act. Such statement may not be signed by a (8) A detailed description in the form person who, in addition to preparing or of a blueprint, diagram, or in writing of assisting in preparing the management

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plan, also implements (or will imple- shall provide written notice to that rel- ment) the management plan. evant group of the availability of man- (g)(1) Upon submission of a manage- agement plans and shall include in the ment plan to the Governor for review, management plan a description of the a local education agency shall keep a steps taken to notify such groups, and copy of the plan in its administrative a dated copy of the notification. office. The management plans shall be (h) Records required under § 763.94 available, without cost or restriction, shall be made by local education agen- for inspection by representatives of cies and maintained as part of the EPA and the State, the public, includ- management plan. ing teachers, other school personnel (i) Each management plan must con- and their representatives, and parents. tain a true and correct statement, The local education agency may charge signed by the individual designated by a reasonable cost to make copies of the local education agency under management plans. § 763.84, which certifies that the gen- (2) Each local education agency shall eral, local education agency respon- maintain in its administrative office a sibilities, as stipulated by § 763.84, have complete, updated copy of a manage- been met or will be met. ment plan for each school under its administrative control or direction. The § 763.94 Recordkeeping. management plans shall be available, (a) Records required under this sec- during normal business hours, without tion shall be maintained in a central- cost or restriction, for inspection by ized location in the administrative of- representatives of EPA and the State, fice of both the school and the local the public, including teachers, other education agency as part of the man- school personnel and their representa- agement plan. For each homogeneous tives, and parents. The local education area where all ACBM has been re- agency may charge a reasonable cost moved, the local education agency to make copies of management plans. shall ensure that such records are re- (3) Each school shall maintain in its tained for 3 years after the next rein- administrative office a complete, up- spection required under § 763.85(b)(1), or dated copy of the management plan for for an equivalent period. that school. Management plans shall be (b) For each preventive measure and available for inspection, without cost response action taken for friable and or restriction, to workers before work nonfriable ACBM and friable and non- begins in any area of a school building. friable suspected ACBM assumed to be The school shall make management ACM, the local education agency shall plans available for inspection to rep- provide: resentatives of EPA and the State, the (1) A detailed written description of public, including parents, teachers, and the measure or action, including meth- other school personnel and their rep- ods used, the location where the meas- resentatives within 5 working days ure or action was taken, reasons for se- after receiving a request for inspection. lecting the measure or action, start The school may charge a reasonable and completion dates of the work, cost to make copies of the manage- names and addresses of all contractors ment plan. involved, and if applicable, their State (4) Upon submission of its manage- of accreditation, and accreditation ment plan to the Governor and at least numbers, and if ACBM is removed, the once each school year, the local edu- name and location of storage or dis- cation agency shall notify in writing posal site of the ACM. parent, teacher, and employee organi- (2) The name and signature of any zations of the availability of manage- person collecting any air sample re- ment plans and shall include in the quired to be collected at the comple- management plan a description of the tion of certain response actions speci- steps taken to notify such organiza- fied by § 763.90(i), the locations where tions, and a dated copy of the notifica- samples were collected, date of collection. In the absence of any such organi- tion, the name and address of the lab- zations for parents, teachers, or em- oratory analyzing the samples, the ployees, the local education agency date of analysis, the results of the

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analysis, the method of analysis, the removed, the name and location of name and signature of the person per- storage or disposal site of the ACM. forming the analysis, and a statement (Approved by the Office of Management and that the laboratory meets the applica- Budget under control number 2070–0091) ble requirements of § 763.90(i)(2)(ii). (c) For each person required to be § 763.95 Warning labels. trained under § 763.92(a) (1) and (2), the (a) The local education agency shall local education agency shall provide attach a warning label immediately ad- the person’s name and job title, the jacent to any friable and nonfriable date that training was completed by ACBM and suspected ACBM assumed to that person, the location of the train- be ACM located in routine mainte- ing, and the number of hours com- nance areas (such as boiler rooms) at pleted in such training. each school building. This shall in- (d) For each time that periodic sur- clude: veillance under § 763.92(b) is performed, (1) Friable ACBM that was responded the local education agency shall record to by a means other than removal. the name of each person performing (2) ACBM for which no response ac- the surveillance, the date of the sur- tion was carried out. veillance, and any changes in the con- (b) All labels shall be prominently ditions of the materials. displayed in readily visible locations (e) For each time that cleaning under and shall remain posted until the § 763.91(c) is performed, the local edu- ACBM that is labeled is removed. cation agency shall record the name of (c) The warning label shall read, in each person performing the cleaning, print which is readily visible because the date of such cleaning, the locations of large size or bright color, as follows: cleaned, and the methods used to per- CAUTION: ASBESTOS. HAZARDOUS. form such cleaning. DO NOT DISTURB WITHOUT PROPER (f) For each time that operations and TRAINING AND EQUIPMENT. maintenance activities under § 763.91(d) are performed, the local education § 763.97 Compliance and enforcement. agency shall record the name of each (a) Compliance with Title II of the Act. person performing the activity, the (1) Section 207(a) of Title II of the Act start and completion dates of the ac- (15 U.S.C. 2647) makes it unlawful for tivity, the locations where such activ- any local education agency to: ity occurred, a description of the activ- (i) Fail to conduct inspections pursu- ity including preventive measures ant to section 203(b) of Title II of the used, and if ACBM is removed, the Act, including failure to follow proce- name and location of storage or dis- dures and failure to use accredited per- posal site of the ACM. sonnel and laboratories. (g) For each time that major asbestos (ii) Knowingly submit false informa- activity under § 763.91(e) is performed, tion to the Governor regarding any in- the local education agency shall pro- spection pursuant to regulations under vide the name and signature, State of section 203(i) of Title II of the Act. accreditation, and if applicable, the ac- (iii) Fail to develop a management creditation number of each person per- plan pursuant to regulations under sec- forming the activity, the start and tion 203(i) of Title II of the Act. completion dates of the activity, the (2) Section 207(a) of Title II of the locations where such activity occurred, Act (15 U.S.C. 2647) also provides that a description of the activity including any local education agency which vio- preventive measures used, and if ACBM lates any provision of section 207 shall is removed, the name and location of be liable for a civil penalty of not more storage or disposal site of the ACM. than $5,000 for each day during which (h) For each fiber release episode the violation continues. For the pur- under § 763.91(f), the local education poses of this subpart, a ‘‘violation’’ agency shall provide the date and loca- means a failure to comply with respect tion of the episode, the method of re- to a single school building. pair, preventive measures or response (b) Compliance with Title I of the Act. action taken, the name of each person (1) Section 15(1)(D) of Title I of the Act performing the work, and if ACBM is (15 U.S.C. 2614) makes it unlawful for

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any person to fail or refuse to comply identified as a citizen complaint pursu- with any requirement of Title II or any ant to section 207(d) of Title II of rule promulgated or order issued under TSCA. The EPA Asbestos Ombudsman Title II. Therefore, any person who vio- or the Governor shall investigate and lates any requirement of this subpart respond to the complaint within a rea- is in violation of section 15 of Title I of sonable period of time if the allega- the Act. tions provide a reasonable basis to be- (2) Section 15(3) of Title I of the Act lieve that a violation of the Act has oc- (15 U.S.C. 2614) makes it unlawful for curred. any person to fail or refuse to establish (f) Inspections. EPA may conduct in- or maintain records, submit reports, spections and review management notices or other information, or permit plans under section 11 of Title I of the access to or copying of records, as re- Act (15 U.S.C. 2610) to ensure compli- quired by this Act or a rule thereunder. ance. (3) Section 15(4) (15 U.S.C. 2614) of Title I of the Act makes it unlawful for § 763.98 Waiver; delegation to State. any person to fail or refuse to permit (a) General. (1) Upon request from a entry or inspection as required by sec- state Governor and after notice and tion 11 of Title I of the Act. comment and an opportunity for a pub- (4) Section 16(a) of Title I of the Act lic hearing in accordance with para- (15 U.S.C. 2615) provides that any person who violates any provision of sec- graphs (b) and (c) of this section, EPA tion 15 of Title I of the Act shall be lia- may waive some or all of the require- ble to the United States for a civil pen- ments of this subpart E if the state has alty in an amount not to exceed $25,000 established and is implementing or infor each such violation. Each day such tends to implement a program of asbes- a violation continues shall, for pur- tos inspection and management that poses of this paragraph, constitute a contains requirements that are at least separate violation of section 15. A local as stringent as the requirements of this education agency is not liable for any subpart. In addition, if the state choos- civil penalty under Title I of the Act es to receive electronic documents, the for failing or refusing to comply with state program must include, at a min- any rule promulgated or order issued imum, the requirements of 40 CFR part under Title II of the Act. 3—(Electronic reporting). (c) Criminal penalties. If any violation (2) A waiver from any requirement of committed by any person (including a this subpart E shall apply only to the local education agency) is knowing or specific provision for which a waiver willful, criminal penalties may be as- has been granted under this section. sessed under section 16(b) of Title I of All requirements of this subpart E the Act. shall apply until a waiver is granted (d) Injunctive relief. The Agency may under this section. obtain injunctive relief under section (b) Request. Each request by a Gov- 208(b) of Title II of the Act to respond ernor to waive any requirement of this to a hazard which poses an imminent subpart E shall be sent with three com- and substantial endangerment to plete copies of the request to the Re- human health or the environment or gional Administrator for the EPA Re- section 17 (15 U.S.C. 2616) of Title I of gion in which the State is located and the Act to restrain any violation of shall include: section 15 of Title I of the Act or to (1) A copy of the State provisions or compel the taking of any action re- proposed provisions relating to its pro- quired by or under Title I of the Act. gram of asbestos inspection and man- (e) Citizen complaints. Any citizen who agement in schools for which the re- wishes to file a complaint pursuant to quest is made. section 207(d) of Title II of the Act (2)(i) The name of the State agency should direct the complaint to the Gov- that is or will be responsible for admin- ernor of the State or the EPA Asbestos istering and enforcing the require- Ombudsman, 1200 Pennsylvania Ave., ments for which a waiver is requested, NW., Washington, DC 20460. The citizen the names and job titles of responsible complaint should be in writing and officials in that agency, and phone

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numbers where the officials can be con- the 30-day period, the request will be tacted. deemed complete. (ii) In the event that more than one (2) Within 30 days after EPA deter- agency is or will be responsible for ad- mines that a request is complete, EPA ministering and enforcing the require- will issue for publication in the FED- ments for which a waiver is requested, ERAL REGISTER a notice that announces a description of the functions to be per- receipt of the request, describes the informed by each agency, how the pro- formation submitted under paragraph gram will be coordinated by the lead (b) of this section, and solicits written agency to ensure consistency and effec- comment from interested members of tive administration in the asbestos in- the public. Comments must be sub- spection and management program mitted within 60 days. within the State, the names and job ti- (3) If, during the comment period, tles of responsible officials in the agen- EPA receives a written objection to a cies, and phone numbers where the offi- Governor’s request and a request for a cials can be contacted. The lead agency public hearing detailing specific objec- will serve as the central contact point tions to the granting of a waiver, EPA for the EPA. will schedule a public hearing to be (3) Detailed reasons, supporting pa- held in the affected State after the pers, and the rationale for concluding close of the comment period and will that the state’s asbestos inspection and announce the public hearing date in management program provisions for the FEDERAL REGISTER before the date which the request is made are at least of the hearing. Each comment shall in- as stringent as the requirements of clude the name and address of the per- Subpart E of this part, and that, if the son submitting the comment. state chooses to receive electronic doc- (d) Criteria. EPA may waive some or all of the requirements of subpart E of uments, the state program includes, at this part if: a minimum, the requirements of 40 (1) The State’s lead agency and other CFR part 3—(Electronic reporting). cooperating agencies have the legal au- (4) A discussion of any special situa- thority necessary to carry out the pro- tions, problems, and needs pertaining visions of asbestos inspection and man- to the waiver request accompanied by agement in schools relating to the an explanation of how the State in- waiver request. tends to handle them. (2) The State’s program of asbestos (5) A statement of the resources that inspection and management in schools the State intends to devote to the ad- relating to the waiver request and im- ministration and enforcement of the plementation of the program are or provisions relating to the waiver re- will be at least as stringent as the request. quirements of this subpart E. (6) Copies of any specific or enabling (3) The state has an enforcement State laws (enacted and pending enact- mechanism to allow it to implement ment) and regulations (promulgated the program described in the waiver re- and pending promulgation) relating to quest and any electronic reporting re- the request, including provisions for quirements are at least as stringent as assessing criminal and/or civil pen- 40 CFR part 3—(Electronic reporting). alties. (4) The lead agency and any cooper- (7) Assurance from the Governor, the ating agencies have or will have quali- Attorney General, or the legal counsel fied personnel to carry out the provi- of the lead agency that the lead agency sions relating to the waiver request. or other cooperating agencies have the (5) The State will devote adequate re- legal authority necessary to carry out sources to the administration and en- the requirements relating to the re- forcement of the asbestos inspection quest. and management provisions relating to (c) General notice—hearing. (1) Within the waiver request. 30 days after receipt of a request for a (6) When specified by EPA, the State waiver, EPA will determine the com- gives satisfactory assurances that nec- pleteness of the request. If EPA does essary steps, including specific actions not request further information within it proposes to take and a time schedule

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for their accomplishment, will be (i) Informal conference. (1) EPA may taken within a reasonable time to con- request that an informal conference be form with applicable criteria under held between appropriate State and paragraphs (d) (2) through (4) of this EPA officials when EPA has reason to section. believe that a State has failed to: (e) Decision. EPA will issue for publi- (i) Substantially comply with the cation in the FEDERAL REGISTER a no- terms of any provision that was waived tice announcing its decision to grant or under this section. deny, in whole or in part, a Governor’s (ii) Meet the criteria under paragraph request for a waiver from some or all of (d) of this section, including the failure the requirements of this subpart E to carry out enforcement activities or within 30 days after the close of the act on violations of the State program. comment period or within 30 days fol- (2) EPA will: lowing a public hearing, whichever is (i) Specify to the State those aspects applicable. The notice will include the of the State’s program believed to be Agency’s reasons and rationale for inadequate. granting or denying the Governor’s re- (ii) Specify to the State the facts quest. The 30-day period may be ex- that underlie the belief of inadequacy. tended if mutually agreed upon by EPA (3) If EPA finds, on the basis of infor- and the State. mation submitted by the State at the (f) Modifications. When any substan- conference, that deficiencies did not tial change is made in the administra- exist or were corrected by the State, no tion or enforcement of a State program further action is required. for which a waiver was granted under (4) Where EPA finds that deficiencies this section, a responsible official in in the State program exist, a plan to the lead agency shall submit such correct the deficiencies shall be nego- changes to EPA. tiated between the State and EPA. The (g) Reports. The lead agency in each plan shall detail the deficiencies found State that has been granted a waiver in the State program, specify the steps by EPA from any requirement of sub- the State has taken or will take to part E of this part shall submit a re- remedy the deficiencies, and establish port to the Regional Administrator for a schedule for each remedial action to the Region in which the State is lo- be initiated. cated at least once every 12 months to (j) Rescission. (1) If the State fails to include the following information: meet with EPA or fails to correct defi- (1) A summary of the State’s imple- ciencies raised at the informal con- mentation and enforcement activities ference, EPA will deliver to the Gov- during the last reporting period relat- ernor of the State and a responsible of- ing to provisions waived under this sec- ficial in the lead agency a written no- tion, including enforcement actions tice of its intent to rescind, in whole or taken. part, the waiver. (2) Any changes in the administra- (2) EPA will issue for publication in tion or enforcement of the State pro- the FEDERAL REGISTER a notice that gram implemented during the last re- announces the rescission of the waiver, porting period. describes those aspects of the State’s program determined to be inadequate, (3) Other reports as may be required and specifies the facts that underlie by EPA to carry out effective oversight the findings of inadequacy. of any requirement of this subpart E that was waived under this section. [52 FR 41846, Oct. 30, 1987, as amended at 70 (h) Oversight. EPA may periodically FR 59889, Oct. 13, 2005] evaluate the adequacy of a State’s implementation and enforcement of and § 763.99 Exclusions. resources devoted to carrying out re- (a) A local education agency shall quirements relating to the waiver. This not be required to perform an inspec- evaluation may include, but is not lim- tion under § 763.85(a) in any sampling ited to, site visits to local education area as defined in 40 CFR 763.103 or ho- agencies without prior notice to the mogeneous area of a school building State. where:

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(1) An accredited inspector has deter- statement in the management plan for mined that, based on sampling records, that school. friable ACBM was identified in that ho- (4) The lead agency responsible for mogeneous or sampling area during an asbestos inspection in a State that has inspection conducted before December been granted a waiver from § 763.85(a) 14, 1987. The inspector shall sign and has determined that, based on sam- date a statement to that effect with his pling records and inspection records, or her State of accreditation and if ap- no ACBM is present in the homo- plicable, accreditation number and, geneous or sampling area and the within 30 days after such determina- records show that the area was sam- tion, submit a copy of the statement to pled before December 14, 1987, in sub- the person designated under § 763.84 for stantial compliance with § 763.85(a). inclusion in the management plan. Such determination shall be included However, an accredited inspector shall in the management plan for that assess the friable ACBM under § 763.88. school. (2) An accredited inspector has deter- (5) An accredited inspector has determined that, based on sampling records, mined that, based on records of an in- nonfriable ACBM was identified in that spection conducted before December 14, homogeneous or sampling area during 1987, suspected ACBM identified in that an inspection conducted before Decem- homogeneous or sampling area is as- ber 14, 1987. The inspector shall sign sumed to be ACM. The inspector shall and date a statement to that effect sign and date a statement to that ef- with his or her State of accreditation fect, with his or her State of accredita- and if applicable, accreditation number tion and if applicable, accreditation and, within 30 days after such deter- number and, within 30 days of such de- mination, submit a copy of the state- termination, submit a copy of the ment to the person designated under statement to the person designated § 763.84 for inclusion in the manage- under § 763.84 for inclusion in the man- ment plan. However, an accredited in- agement plan. However, an accredited spector shall identify whether material inspector shall identify whether mate- that was nonfriable has become friable rial that was nonfriable suspected since that previous inspection and ACBM assumed to be ACM has become shall assess the newly-friable ACBM friable since the previous inspection under § 763.88. and shall assess the newly friable ma- (3) Based on sampling records and in- terial and previously identified friable spection records, an accredited inspec- suspected ACBM assumed to be ACM tor has determined that no ACBM is under § 763.88. present in the homogeneous or sam- (6) Based on inspection records and pling area and the records show that contractor and clearance records, an the area was sampled, before December accredited inspector has determined 14, 1987 in substantial compliance with that no ACBM is present in the homo- § 763.85(a), which for purposes of this geneous or sampling area where asbes- section means in a random manner and tos removal operations have been con- with a sufficient number of samples to ducted before December 14, 1987, and reasonably ensure that the area is not shall sign and date a statement to that ACBM. effect and include his or her State of (i) The accredited inspector shall accreditation and, if applicable, accred- sign and date a statement, with his or itation number. The local education her State of accreditation and if appli- agency shall submit a copy of the cable, accreditation number that the statement to the EPA Regional Office homogeneous or sampling area deter- and shall include the statement in the mined not to be ACBM was sampled in management plan for that school. substantial compliance with § 763.85(a). (7) An architect or project engineer (ii) Within 30 days after the inspec- responsible for the construction of a tor’s determination, the local edu- new school building built after October cation agency shall submit a copy of 12, 1988, or an accredited inspector the inspector’s statement to the EPA signs a statement that no ACBM was Regional Office and shall include the specified as a building material in any

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construction document for the build- ments as are outlined in the mandatory ing, or, to the best of his or her knowl- method. Hence, laboratories may choose ei- edge, no ACBM was used as a building ther of the two methods for analyzing air samples by TEM. material in the building. The local edu- The final unit of this Appendix A to sub- cation agency shall submit a copy of part E defines the steps which must be taken the signed statement of the architect, to determine completion of response actions. project engineer, or accredited inspec- This unit is mandatory. tor to the EPA Regional Office and shall include the statement in the II. Mandatory Transmission Electron Microscopy Method management plan for that school. (b) The exclusion, under paragraphs A. Definitions of Terms (a) (1) through (4) of this section, from 1. Analytical sensitivity—Airborne asbestos conducting the inspection under concentration represented by each fiber § 763.85(a) shall apply only to homo- counted under the electron microscope. It is geneous or sampling areas of a school determined by the air volume collected and building that were inspected and sam- the proportion of the filter examined. This pled before October 17, 1987. The local method requires that the analytical sensi- education agency shall conduct an in- tivity be no greater than 0.005 structures/ cm3. spection under § 763.85(a) of all areas in- 2. Asbestiform—A specific type of mineral spected before October 17, 1987, that fibrosity in which the fibers and fibrils pos- were not sampled or were not assumed sess high tensile strength and flexibility. to be ACM. 3. Aspect ratio—A ratio of the length to the (c) If ACBM is subsequently found in width of a particle. Minimum aspect ratio as a homogeneous or sampling area of a defined by this method is equal to or greater than 5:1. local education agency that had been 4. Bundle—A structure composed of three identified as receiving an exclusion by or more fibers in a parallel arrangement an accredited inspector under para- with each fiber closer than one fiber diame- graphs (a) (3), (4), (5) of this section, or ter. an architect, project engineer or ac- 5. Clean area—A controlled environment credited inspector under paragraph which is maintained and monitored to assure (a)(7) of this section, the local edu- a low probability of asbestos contamination cation agency shall have 180 days fol- to materials in that space. Clean areas used in this method have HEPA filtered air under lowing the date of identification of positive pressure and are capable of sus- ACBM to comply with this subpart E. tained operation with an open laboratory blank which on subsequent analysis has an APPENDIX A TO SUBPART E OF PART average of less than 18 structures/mm2 in an 763—INTERIM TRANSMISSION ELEC- area of 0.057 mm2 (nominally 10 200-mesh grid TRON MICROSCOPY ANALYTICAL openings) and a maximum of 53 structures/ METHODS—MANDATORY AND NON- mm2 for any single preparation for that same MANDATORY—AND MANDATORY SEC- area. 6. Cluster—A structure with fibers in a ran- TION TO DETERMINE COMPLETION OF dom arrangement such that all fibers are RESPONSE ACTIONS intermixed and no single fiber is isolated I. Introduction from the group. Groupings must have more than two intersections. The following appendix contains three 7. ED—Electron diffraction. units. The first unit is the mandatory trans- 8. EDXA—Energy dispersive X-ray anal- mission electron microscopy (TEM) method ysis. which all laboratories must follow; it is the 9. Fiber—A structure greater than or equal minimum requirement for analysis of air to 0.5 μm in length with an aspect ratio samples for asbestos by TEM. The manda- (length to width) of 5:1 or greater and having tory method contains the essential elements substantially parallel sides. of the TEM method. The second unit con- 10. Grid—An open structure for mounting tains the complete non-mandatory method. on the sample to aid in its examination in The non-mandatory method supplements the the TEM. The term is used here to denote a mandatory method by including additional 200-mesh copper lattice approximately 3 mm steps to improve the analysis. EPA rec- in diameter. ommends that the non-mandatory method be 11. Intersection—Nonparallel touching or employed for analyzing air filters; however, crossing of fibers, with the projection having the laboratory may choose to employ the an aspect ratio of 5:1 or greater. mandatory method. The non-mandatory 12. Laboratory sample coordinator—That per- method contains the same minimum require- son responsible for the conduct of sample

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handling and the certification of the testing B. Sampling procedures. 13. Filter background level—The concentra- 1. The sampling agency must have written tion of structures per square millimeter of quality control procedures and documents filter that is considered indistinguishable which verify compliance. from the concentration measured on a blank 2. Sampling operations must be performed (filters through which no air has been by qualified individuals completely inde- drawn). For this method the filter back- pendent of the abatement contractor to ground level is defined as 70 structures/mm2. avoid possible conflict of interest (Ref- 14. Matrix—Fiber or fibers with one end erences 1, 2, 3, and 5 of Unit II.J.). free and the other end embedded in or hidden 3. Sampling for airborne asbestos following by a particulate. The exposed fiber must an abatement action must use commercially meet the fiber definition. available cassettes. 15. NSD—No structure detected. 4. Prescreen the loaded cassette collection 16. Operator—A person responsible for the filters to assure that they do not contain TEM instrumental analysis of the sample. concentrations of asbestos which may inter- 17. PCM—Phase contrast microscopy. fere with the analysis of the sample. A filter 18. SAED—Selected area electron diffrac- blank average of less than 18 s/mm2 in an tion. area of 0.057 mm2 (nominally 10 200-mesh grid 19. SEM—Scanning electron microscope. openings) and a single preparation with a 20. STEM—Scanning transmission electron maximum of 53 s/mm2 for that same area is microscope. acceptable for this method. 21. Structure—a microscopic bundle, clus- 5. Use sample collection filters which are ter, fiber, or matrix which may contain as- either polycarbonate having a pore size less bestos. than or equal to 0.4 μm or mixed cellulose 22. S/cm3—Structures per cubic centimeter. ester having a pore size less than or equal to 23. S/mm2—Structures per square milli- 0.45 μm. meter. 6. Place these filters in series with a 5.0 μm 24. TEM—Transmission electron micro- backup filter (to serve as a diffuser) and a scope. support pad. See the following Figure 1:

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7. Reloading of used cassettes is not per- 9. Maintain a log of all pertinent sampling mitted. information. 8. Orient the cassette downward at approximately 45 degrees from the horizontal.

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10. Calibrate sampling pumps and their 17. A minimum of 13 samples are to be col- flow indicators over the range of their in- lected for each testing site consisting of the tended use with a recognized standard. As- following: semble the sampling system with a rep- a. A minimum of five samples per abate- resentative filter (not the filter which will ment area. be used in sampling) before and after the b. A minimum of five samples per ambient sampling operation. area positioned at locations representative 11. Record all calibration information. of the air entering the abatement site. c. Two field blanks are to be taken by re- 12. Ensure that the mechanical vibrations moving the cap for not more than 30 seconds from the pump will be minimized to prevent and replacing it at the time of sampling be- transferral of vibration to the cassette. fore sampling is initiated at the following 13. Ensure that a continuous smooth flow places: of negative pressure is delivered by the pump i. Near the entrance to each abatement by damping out any pump action fluctua- area. tions if necessary. ii. At one of the ambient sites. (DO NOT 14. The final plastic barrier around the leave the field blanks open during the sam- abatement area remains in place for the pling period.) sampling period. d. A sealed blank is to be carried with each 15. After the area has passed a thorough sample set. This representative cassette is visual inspection, use aggressive sampling not to be opened in the field. conditions to dislodge any remaining dust. 18. Perform a leak check of the sampling (See suggested protocol in Unit III.B.7.d.) system at each indoor and outdoor sampling 16. Select an appropriate flow rate equal to site by activating the pump with the closed sampling cassette in line. Any flow indicates or greater than 1 liter per minute (L/min) or a leak which must be eliminated before initi- less than 10 L/min for 25 mm cassettes. Larg- ating the sampling operation. er filters may be operated at proportionally 19. The following Table I specifies volume higher flow rates. ranges to be used:

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20. Ensure that the sampler is turned up- 22. Ensure that the samples are stored in a right before interrupting the pump flow. secure and representative location. 21. Check that all samples are clearly la- 23. Do not change containers if portions of beled and that all pertinent information has these filters are taken for other purposes. been enclosed before transfer of the samples 24. A summary of Sample Data Quality Ob- to the laboratory. jectives is shown in the following Table II:

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C. Sample Shipment a. TEM Grid Opening Area measurement must be done as follows: Ship bulk samples to the analytical laboratory in a separate container from air i. The filter portion being used for sample samples. preparation must have the surface collapsed using an acetone vapor technique. D. Sample Receiving ii. Measure 20 grid openings on each of 20 random 200-mesh copper grids by placing a 1. Designate one individual as sample coor- grid on a glass and examining it under the dinator at the laboratory. While that indi- PCM. Use a calibrated graticule to measure vidual will normally be available to receive the average field diameters. From the data, samples, the coordinator may train and su- calculate the field area for an average grid pervise others in receiving procedures for opening. those times when he/she is not available. 2. Bulk samples and air samples delivered iii. Measurements can also be made on the to the analytical laboratory in the same con- TEM at a properly calibrated low magnifica- tainer shall be rejected. tion or on an optical microscope at a magnification of approximately 400X by using an E. Sample Preparation eyepiece fitted with a scale that has been calibrated against a stage micrometer. Opti- 1. All sample preparation and analysis cal microscopy utilizing manual or auto- shall be performed by a laboratory inde- mated procedures may be used providing in- pendent of the abatement contractor. strument calibration can be verified. 2. Wet-wipe the exterior of the cassettes to b. TEM specimen preparation from minimize contamination possibilities before polycarbonate (PC) filters. Procedures as de- taking them into the clean room facility. scribed in Unit III.G. or other equivalent 3. Perform sample preparation in a well- methods may be used. equipped clean facility. NOTE: The clean area is required to have c. TEM specimen preparation from mixed the following minimum characteristics. The cellulose ester (MCE) filters. area or hood must be capable of maintaining i. Filter portion being used for sample a positive pressure with make-up air being preparation must have the surface collapsed HEPA-filtered. The cumulative analytical using an acetone vapor technique or the blank concentration must average less than Burdette procedure (Ref. 7 of Unit II.J.) 18 s/mm2 in an area of 0.057 mm2 (nominally ii. Plasma etching of the collapsed filter is 10 200-mesh grid openings) and a single prep- required. The microscope slide to which the aration with a maximum of 53 s/mm2 for that collapsed filter pieces are attached is placed same area. in a plasma asher. Because plasma ashers 4. Preparation areas for air samples must vary greatly in their performance, both from not only be separated from preparation areas unit to unit and between different positions for bulk samples, but they must be prepared in the asher chamber, it is difficult to speci- in separate rooms. fy the conditions that should be used. Insuf- 5. Direct preparation techniques are re- ficient etching will result in a failure to ex- quired. The object is to produce an intact pose embedded filters, and too much etching film containing the particulates of the filter may result in loss of particulate from the surface which is sufficiently clear for TEM surface. As an interim measure, it is rec- analysis. ommended that the time for ashing of a

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known weight of a collapsed filter be estab- be metric). A logbook must be maintained, lished and that the etching rate be cal- and the dates of calibration and the values culated in terms of micrometers per second. obtained must be recorded. The frequency of The actual etching time used for the particu- calibration depends on the past history of late asher and operating conditions will then the particular microscope. After any mainte- be set such that a 1–2 μm (10 percent) layer nance of the microscope that involved ad- of collapsed surface will be removed. justment of the power supplied to the lenses iii. Procedures as described in Unit III. or or the high-voltage system or the mechan- other equivalent methods may be used to ical disassembly of the electron optical col- prepare samples. umn apart from filament exchange, the magnification must be recalibrated. Before the F. TEM Method TEM calibration is performed, the analyst 1. An 80–120 kV TEM capable of performing must ensure that the cross grating replica is electron diffraction with a fluorescent screen placed at the same distance from the objec- inscribed with calibrated gradations is re- tive lens as the specimens are. For instru- quired. If the TEM is equipped with EDXA it ments that incorporate a eucentric tilting must either have a STEM attachment or be specimen stage, all specimens and the cross capable of producing a spot less than 250 nm grating replica must be placed at the in diameter at crossover. The microscope eucentric position. shall be calibrated routinely for magnifica- 4. While not required on every microscope tion and camera constant. in the laboratory, the laboratory must have 2. Determination of Camera Constant and ED either one microscope equipped with energy Pattern Analysis. The camera length of the dispersive X-ray analysis or access to an TEM in ED operating mode must be cali- equivalent system on a TEM in another lab- brated before ED patterns on unknown sam- oratory. ples are observed. This can be achieved by 5. Microscope settings: 80–120 kV, grid as- using a carbon-coated grid on which a thin sessment 250–1,000X, then 15,000–20,000X film of gold has been sputtered or evapo- screen magnification for analysis. rated. A thin film of gold is evaporated on 6. Approximately one-half (0.5) of the pre- the specimen TEM grid to obtain zone-axis determined sample area to be analyzed shall ED patterns superimposed with a ring pat- be performed on one sample grid preparation tern from the polycrystalline gold film. In and the remaining half on a second sample practice, it is desirable to optimize the grid preparation. thickness of the gold film so that only one or 7. Individual grid openings with greater two sharp rings are obtained on the super- than 5 percent openings (holes) or covered imposed ED pattern. Thicker gold film would with greater than 25 percent particulate normally give multiple gold rings, but it will matter or obviously having nonuniform load- tend to mask weaker diffraction spots from ing must not be analyzed. the unknown fibrous particulate. Since the 8. Reject the grid if: unknown d-spacings of most interest in as- a. Less than 50 percent of the grid openings bestos analysis are those which lie closest to covered by the replica are intact. the transmitted beam, multiple gold rings b. The replica is doubled or folded. are unnecessary on zone-axis ED patterns. c. The replica is too dark because of incom- An average camera constant using multiple plete dissolution of the filter. gold rings can be determined. The camera 9. Recording Rules. constant is one-half the diameter of the a. Any continuous grouping of particles in rings times the interplanar spacing of the which an asbestos fiber with an aspect ratio ring being measured. greater than or equal to 5:1 and a length 3. Magnification Calibration. The magnifica- greater than or equal to 0.5 μm is detected tion calibration must be done at the fluores- shall be recorded on the count sheet. These cent screen. The TEM must be calibrated at will be designated asbestos structures and the grid opening magnification (if used) and will be classified as fibers, bundles, clusters, also at the magnification used for fiber or matrices. Record as individual fibers any counting. This is performed with a cross contiguous grouping having 0, 1, or 2 defin- grating replica (e.g., one containing 2,160 able intersections. Groupings having more lines/mm). Define a field of view on the fluo- than 2 intersections are to be described as rescent screen either by markings or phys- cluster or matrix. An intersection is a non- ical boundaries. The field of view must be parallel touching or crossing of fibers, with measurable or previously inscribed with a the projection having an aspect ratio of 5:1 scale or concentric circles (all scales should or greater. See the following Figure 2:

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i. Fiber. A structure having a minimum from the group. Groupings must have more length greater than or equal to 0.5 μm and an than two intersections. aspect ratio (length to width) of 5:1 or great- iv. Matrix. Fiber or fibers with one end free er and substantially parallel sides. Note the and the other end embedded in or hidden by appearance of the end of the fiber, i.e., a particulate. The exposed fiber must meet whether it is flat, rounded or dovetailed. the fiber definition. ii. Bundle. A structure composed of three b. Separate categories will be maintained or more fibers in a parallel arrangement for fibers less than 5 μm and for fibers equal with each fiber closer than one fiber diame- to or greater than 5 μm in length. ter. c. Record NSD when no structures are de- iii. Cluster. A structure with fibers in a tected in the field. random arrangement such that all fibers are d. Visual identification of electron diffrac- intermixed and no single fiber is isolated tion (ED) patterns is required for each asbestos structure counted which would cause the

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analysis to exceed the 70 s/mm2 concentra- 11. After finishing with a grid, remove it tion. (Generally this means the first four fi- from the microscope, and replace it in the bers identified as asbestos must exhibit an appropriate grid holder. Sample grids must identifiable diffraction pattern for chrysotile be stored for a minimum of 1 year from the or amphibole.) date of the analysis; the sample cassette e. The micrograph number of the recorded must be retained for a minimum of 30 days diffraction patterns must be reported to the by the laboratory or returned at the client’s client and maintained in the laboratory’s request. quality assurance records. In the event that examination of the pattern by a qualified in- G. Sample Analytical Sequence dividual indicates that the pattern has been 1. Under the present sampling require- misidentified visually, the client shall be ments a minimum of 13 samples is to be col- contacted. lected for the clearance testing of an abate- f. Energy Dispersive X-ray Analysis ment site. These include five abatement area (EDXA) is required of all amphiboles which samples, five ambient samples, two field would cause the analysis results to exceed blanks, and one sealed blank. the 70 s/mm2 concentration. (Generally 2. Carry out visual inspection of work site speaking, the first 4 amphiboles would re- prior to air monitoring. quire EDXA.) 3. Collect a minimum of 5 air samples in- g. If the number of fibers in the non- side the work site and 5 samples outside the asbestos class would cause the analysis to work site. The indoor and outdoor samples exceed the 70 s/mm2 concentration, the fact shall be taken during the same time period. that they are not asbestos must be con- 4. Remaining steps in the analytical se- firmed by EDXA or measurement of a zone quence are contained in Unit IV of this Ap- axis diffraction pattern. pendix. h. Fibers classified as chrysotile must be identified by diffraction or X-ray analysis H. Reporting and recorded on a count sheet. X-ray anal- 1. The following information must be re- ysis alone can be used only after 70 s/mm2 ported to the client for each sample ana- have been exceeded for a particular sample. lyzed: i. Fibers classified as amphiboles must be a. Concentration in structures per square identified by X-ray analysis and electron dif- millimeter and structures per cubic centi- fraction and recorded on the count sheet. (X- meter. ray analysis alone can be used only after 70 b. Analytical sensitivity used for the anal- s/mm2 have been exceeded for a particular ysis. sample.) c. Number of asbestos structures. j. If a diffraction pattern was recorded on d. Area analyzed. film, record the micrograph number on the e. Volume of air sampled (which must be count sheet. initially supplied to lab by client). k. If an electron diffraction was attempted f. Copy of the count sheet must be included but no pattern was observed, record N on the with the report. count sheet. g. Signature of laboratory official to indi- l. If an EDXA spectrum was attempted but cate that the laboratory met specifications not observed, record N on the count sheet. of the method. m. If an X-ray analysis spectrum is stored, h. Report form must contain official lab- record the file and disk number on the count oratory identification (e.g., letterhead). sheet. i. Type of asbestos. 10. Classification Rules. a. Fiber. A structure having a minimum I. Quality Control/Quality Assurance length greater than or equal to 0.5 μm and an Procedures (Data Quality Indicators) aspect ratio (length to width) of 5:1 or great- Monitoring the environment for airborne er and substantially parallel sides. Note the asbestos requires the use of sensitive sam- appearance of the end of the fiber, i.e., pling and analysis procedures. Because the whether it is flat, rounded or dovetailed. test is sensitive, it may be influenced by a b. Bundle. A structure composed of three or variety of factors. These include the supplies more fibers in a parallel arrangement with used in the sampling operation, the perform- each fiber closer than one fiber diameter. ance of the sampling, the preparation of the c. Cluster. A structure with fibers in a ran- grid from the filter and the actual examina- dom arrangement such that all fibers are tion of this grid in the microscope. Each of intermixed and no single fiber is isolated these unit operations must produce a prod- from the group. Groupings must have more uct of defined quality if the analytical result than two intersections. is to be a reliable and meaningful test result. d. Matrix. Fiber or fibers with one end free Accordingly, a series of control checks and and the other end embedded in or hidden by reference standards are to be performed a particulate. The exposed fiber must meet along with the sample analysis as indicators the fiber definition. that the materials used are adequate and the

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operations are within acceptable limits. In develop within the sampling and analysis op- this way, the quality of the data is defined erations. A description of these quality con- and the results are of known value. These trol/quality assurance procedures is summa- checks and tests also provide timely and spe- rized in the following Table III: cific warning of any problems which might

1. When the samples arrive at the labora- 3. Conduct all sample preparation in a tory, check the samples and documentation clean room environment monitored by lab- for completeness and requirements before oratory blanks. Testing with blanks must initiating the analysis. also be done after cleaning or servicing the 2. Check all laboratory reagents and sup- room. plies for acceptable asbestos background lev- 4. Prepare multiple grids of each sample. els.

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5. Provide laboratory blanks with each ‘‘Proposed Analytical Method for Determina- sample batch. Maintain a cumulative aver- tion of Asbestos in Air.’’ age of these results. If there are more than 53 8. Chatfield, E.J., Chatfield Tech. Cons., fibers/mm2 per 10 200-mesh grid openings, the Ltd., Clark, T., PEI Assoc., ‘‘Standard Oper- system must be checked for possible sources ating Procedure for Determination of Air- of contamination. borne Asbestos Fibers by Transmission Elec- 6. Perform a system check on the trans- tron Microscopy Using Polycarbonate Mem- mission electron microscope daily. brane Filters,’’ WERL SOP 87–1, March 5, 7. Make periodic performance checks of 1987. magnification, electron diffraction and en- 9. NIOSH Method 7402 for Asbestos Fibers, ergy dispersive X-ray systems as set forth in 12–11–86 Draft. Table III under Unit II.I. 10. Yamate, G., Agarwall, S.C., Gibbons, 8. Ensure qualified operator performance R.D., IIT Research Institute, ‘‘Methodology by evaluation of replicate analysis and for the Measurement of Airborne Asbestos by standard sample comparisons as set forth in Electron Microscopy,’’ Draft report, USEPA Table III under Unit II.I. Contract 68–02–3266, July 1984. 9. Validate all data entries. 11. ‘‘Guidance to the Preparation of Qual- 10. Recalculate a percentage of all com- ity Assurance Project Plans,’’ USEPA, Office putations and automatic data reduction of Pollution Prevention and Toxics, 1984. steps as specified in Table III under Unit II.I. III. Nonmandatory Transmission Electron 11. Record an electron diffraction pattern Microscopy Method of one asbestos structure from every five samples that contain asbestos. Verify the A. Definitions of Terms identification of the pattern by measurement or comparison of the pattern with pat- 1. Analytical sensitivity—Airborne asbestos concentration represented by each fiber terns collected from standards under the counted under the electron microscope. It is same conditions. The records must also dem- determined by the air volume collected and onstrate that the identification of the pat- the proportion of the filter examined. This tern has been verified by a qualified indi- method requires that the analytical sensi- vidual and that the operator who made the tivity be no greater than 0.005 s/cm3. identification is maintaining at least an 80 2. Asbestiform—A specific type of mineral percent correct visual identification based fibrosity in which the fibers and fibrils pos- on his measured patterns. sess high tensile strength and flexibility. 12. Appropriate logs or records must be 3. Aspect ratio—A ratio of the length to the maintained by the analytical laboratory width of a particle. Minimum aspect ratio as verifying that it is in compliance with the defined by this method is equal to or greater mandatory quality assurance procedures. than 5:1. J. References 4. Bundle—A structure composed of three or more fibers in a parallel arrangement For additional background information on with each fiber closer than one fiber diame- this method, the following references should ter. be consulted. 5. Clean area—A controlled environment 1. ‘‘Guidance for Controlling Asbestos-Con- which is maintained and monitored to assure taining Materials in Buildings,’’ EPA 560/5– a low probability of asbestos contamination 85–024, June 1985. to materials in that space. Clean areas used 2. ‘‘Measuring Airborne Asbestos Following in this method have HEPA filtered air under an Abatement Action,’’ USEPA, Office of positive pressure and are capable of sus- Pollution Prevention and Toxics, EPA 600/4– tained operation with an open laboratory 85–049, 1985. blank which on subsequent analysis has an 3. Small, John and E. Steel. Asbestos average of less than 18 structures/mm2 in an Standards: Materials and Analytical Meth- area of 0.057 mm2 (nominally 10 200 mesh grid ods. N.B.S. Special Publication 619, 1982. openings) and a maximum of 53 structures/ 4. Campbell, W.J., R.L. Blake, L.L. Brown, mm2 for no more than one single preparation E.E. Cather, and J.J. Sjoberg. Selected Sili- for that same area. cate Minerals and Their Asbestiform Vari- 6. Cluster—A structure with fibers in a ran- eties. Information Circular 8751, U.S. Bureau dom arrangement such that all fibers are of Mines, 1977. intermixed and no single fiber is isolated 5. Quality Assurance Handbook for Air Pol- from the group. Groupings must have more lution Measurement System. Ambient Air than two intersections. Methods, EPA 600/4–77–027a, USEPA, Office of 7. ED—Electron diffraction. Research and Development, 1977. 8. EDXA—Energy dispersive X-ray anal- 6. Method 2A: Direct Measurement of Gas ysis. Volume through Pipes and Small Ducts. 40 9. Fiber—A structure greater than or equal CFR Part 60 Appendix A. to 0.5 μm in length with an aspect ratio 7. Burdette, G.J., Health & Safety Exec. (length to width) of 5:1 or greater and having Research & Lab. Services Div., London, substantially parallel sides.

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10. Grid—An open structure for mounting do not take cross contamination possibilities on the sample to aid in its examination in into account should not be used. the TEM. The term is used here to denote a 2. Material and supply checks for asbestos 200-mesh copper lattice approximately 3 mm contamination should be made on all critical in diameter. supplies, reagents, and procedures before 11. Intersection—Nonparallel touching or their use in a monitoring study. crossing of fibers, with the projection having 3. Quality control and quality assurance an aspect ratio of 5:1 or greater. steps are needed to identify problem areas 12. Laboratory sample coordinator—That per- and isolate the cause of the contamination son responsible for the conduct of sample (see Reference 5 of Unit III.L.). Control handling and the certification of the testing checks shall be permanently recorded to doc- procedures. ument the quality of the information pro- 13. Filter background level—The concentra- duced. The sampling firm must have written tion of structures per square millimeter of quality control procedures and documents filter that is considered indistinguishable which verify compliance. Independent audits from the concentration measured on blanks by a qualified consultant or firm should be (filters through which no air has been performed once a year. All documentation of drawn). For this method the filter back- compliance should be retained indefinitely ground level is defined as 70 structures/mm2. to provide a guarantee of quality. A sum- 14. Matrix—Fiber or fibers with one end mary of Sample Data Quality Objectives is free and the other end embedded in or hidden shown in Table II of Unit II.B. by a particulate. The exposed fiber must 4. Sampling materials. meet the fiber definition. a. Sample for airborne asbestos following 15. NSD—No structure detected. an abatement action using commercially 16. Operator—A person responsible for the available cassettes. TEM instrumental analysis of the sample. b. Use either a cowling or a filter-retaining 17. PCM—Phase contrast microscopy. middle piece. Conductive material may re- 18. SAED—Selected area electron diffrac- duce the potential for particulates to adhere tion. to the walls of the cowl. 19. SEM—Scanning electron microscope. c. Cassettes must be verified as ‘‘clean’’ 20. STEM—Scanning transmission electron prior to use in the field. If packaged filters microscope. are used for loading or preloaded cassettes 21. Structure—a microscopic bundle, clus- are purchased from the manufacturer or a ter, fiber, or matrix which may contain as- distributor, the manufacturer’s name and lot bestos. number should be entered on all field data 22. S/cm3—Structures per cubic centimeter. sheets provided to the laboratory, and are re- 23. S/mm2—Structures per square milli- quired to be listed on all reports from the meter. laboratory. 24. TEM—Transmission electron micro- d. Assemble the cassettes in a clean facil- scope. ity (See definition of clean area under Unit III.A.). B. Sampling e. Reloading of used cassettes is not per- 1. Sampling operations must be performed mitted. by qualified individuals completely inde- f. Use sample collection filters which are pendent of the abatement contractor to either polycarbonate having a pore size of avoid possible conflict of interest (See Ref- less than or equal to 0.4 μm or mixed cel- erences 1, 2, and 5 of Unit III.L.) Special pre- lulose ester having a pore size of less than or cautions should be taken to avoid contami- equal to 0.45 μm. nation of the sample. For example, materials g. Place these filters in series with a that have not been prescreened for their as- backup filter with a pore size of 5.0 μm (to bestos background content should not be serve as a diffuser) and a support pad. See used; also, sample handling procedures which the following Figure 1:

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h. When polycarbonate filters are used, po- i. Seal the cassettes to prevent leakage sition the highly reflective face such that around the filter edges or between cassette the incoming particulate is received on this part joints. A mechanical press may be use- surface. ful to achieve a reproducible leak-free seal.

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Shrink fit gel-bands may be used for this d. Check the sampling system for leaks purpose and are available from filter manu- with the end cap still in place and the pump facturers and their authorized distributors. operating before initiating sample collec- j. Use wrinkle-free loaded cassettes in the tion. Trace and stop the source of any flow sampling operation. indicated by the flowmeter under these con- 5. Pump setup. ditions. a. Calibrate the sampling pump over the e. Select an appropriate flow rate equal to range of flow rates and loads anticipated for or greater than 1 L/min or less than 10 L/min the monitoring period with this flow meas- for 25 mm cassettes. Larger filters may be uring device in series. Perform this calibra- operated at proportionally higher flow rates. tion using guidance from EPA Method 2A each time the unit is sent to the field (See f. Orient the cassette downward at approxi- Reference 6 of Unit III.L.). mately 45 degrees from the horizontal. b. Configure the sampling system to pre- g. Maintain a log of all pertinent sampling clude pump vibrations from being trans- information, such as pump identification mitted to the cassette by using a sampling number, calibration data, sample location, stand separate from the pump station and date, sample identification number, flow making connections with flexible tubing. rates at the beginning, middle, and end, start c. Maintain continuous smooth flow condi- and stop times, and other useful information tions by damping out any pump action fluc- or comments. Use of a sampling log form is tuations if necessary. recommended. See the following Figure 2:

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h. Initiate a chain of custody procedure at j. Continue sampling until at least the the start of each sampling, if this is re- minimum volume is collected, as specified in quested by the client. the following Table I: i. Maintain a close check of all aspects of the sampling operation on a regular basis.

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k. At the conclusion of sampling, turn the closed and appropriately identified using a cassette upward before stopping the flow to waterproof label. Protect cassettes in indi- minimize possible particle loss. If the sam- vidual clean resealed polyethylene bags. pling is resumed, restart the flow before re- Bags are to be used for storing cassette caps orienting the cassette downward. Note the when they are removed for sampling pur- condition of the filter at the conclusion of poses. Caps and plugs should only be resampling. moved or replaced using clean hands or clean l. Double check to see that all information disposable plastic gloves. has been recorded on the data collection m. Do not change containers if portions of forms and that the cassette is securely these filters are taken for other purposes.

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6. Minimum sample number per site. A that electrical equipment does not become minimum of 13 samples are to be collected wet while operational. for each testing consisting of the following: vi. Low volume pumps may be carefully a. A minimum of five samples per abate- wrapped in 6-mil polyethylene to insulate ment area. the pump from the air. High volume pumps b. A minimum of five samples per ambient cannot be sealed in this manner since the area positioned at locations representative heat of the motor may melt the plastic. The of the air entering the abatement site. pump exhausts should be kept free. c. Two field blanks are to be taken by re- vii. If recleaning is necessary, removal of moving the cap for not more than 30 sec and this equipment from the work area must be replacing it at the time of sampling before handled with care. It is not possible to com- sampling is initiated at the following places: pletely decontaminate the pump motor and i. Near the entrance to each ambient area. parts since these areas cannot be wetted. To ii. At one of the ambient sites. minimize any problems in this area, all (NOTE: Do not leave the blank open during equipment such as fans and pumps should be the sampling period.) carefully wet wiped prior to removal from d. A sealed blank is to be carried with each the abatement area. Wrapping and sealing sample set. This representative cassette is low volume pumps in 6-mil polyethylene will not to be opened in the field. provide easier decontamination of this 7. Abatement area sampling. equipment. Use of clean water and disposable a. Conduct final clearance sampling only wipes should be available for this purpose. after the primary containment barriers have e. Pump flow rate equal to or greater than been removed; the abatement area has been 1 L/min or less than 10 L/min may be used for thoroughly dried; and, it has passed visual 25 mm cassettes. The larger cassette diame- inspection tests by qualified personnel. (See ters may have comparably increased flow. Reference 1 of Unit III.L.) f. Sample a volume of air sufficient to en- b. Containment barriers over windows, sure the minimum quantitation limits. (See doors, and air passageways must remain in Table I of Unit III.B.5.j.) place until the TEM clearance sampling and 8. Ambient sampling. analysis is completed and results meet clear- a. Position ambient samplers at locations ance test criteria. The final plastic barrier representative of the air entering the abate- remains in place for the sampling period. ment site. If makeup air entering the abate- c. Select sampling sites in the abatement ment site is drawn from another area of the area on a random basis to provide unbiased building which is outside of the abatement and representative samples. area, place the pumps in the building, pumps d. After the area has passed a thorough vis- should be placed out of doors located near ual inspection, use aggressive sampling con- the building and away from any obstructions ditions to dislodge any remaining dust. that may influence wind patterns. If con- i. Equipment used in aggressive sampling struction is in progress immediately outside such as a leaf blower and/or fan should be the enclosure, it may be necessary to select properly cleaned and decontaminated before another ambient site. Samples should be rep- use. resentative of any air entering the work site. ii. Air filtration units shall remain on dur- b. Locate the ambient samplers at least 3 ing the air monitoring period. ft apart and protect them from adverse iii. Prior to air monitoring, floors, ceiling weather conditions. and walls shall be swept with the exhaust of c. Sample same volume of air as samples a minimum one (1) horsepower leaf blower. taken inside the abatement site. iv. Stationary fans are placed in locations C. Sample Shipment which will not interfere with air monitoring equipment. Fan air is directed toward the 1. Ship bulk samples in a separate con- ceiling. One fan shall be used for each 10,000 tainer from air samples. Bulk samples and ft3 of worksite. air samples delivered to the analytical lab- v. Monitoring of an abatement work area oratory in the same container shall be re- with high-volume pumps and the use of cir- jected. culating fans will require electrical power. 2. Select a rigid shipping container and Electrical outlets in the abatement area pack the cassettes upright in a noncontami- may be used if available. If no such outlets nating nonfibrous medium such as a bubble are available, the equipment must be sup- pack. The use of resealable polyethylene plied with electricity by the use of extension bags may help to prevent jostling of indi- cords and strip plug units. All electrical vidual cassettes. power supply equipment of this type must be 3. Avoid using expanded polystyrene be- approved Underwriter Laboratory equipment cause of its static charge potential. Also that has not been modified. All wiring must avoid using particle-based packaging mate- be grounded. Ground fault interrupters rials because of possible contamination. should be used. Extreme care must be taken 4. Include a shipping bill and a detailed to clean up any residual water and ensure listing of samples shipped, their descriptions

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and all identifying numbers or marks, sam- 4. Ensure that the samples are stored in a pling data, shipper’s name, and contact in- secure and representative location. formation. For each sample set, designate 5. Ensure that mechanical calibrations which are the ambient samples, which are from the pump will be minimized to prevent the abatement area samples, which are the transferral of vibration to the cassette. field blanks, and which is the sealed blank if 6. Ensure that a continuous smooth flow of sequential analysis is to be performed. negative pressure is delivered by the pump 5. Hand-carry samples to the laboratory in by installing a damping chamber if nec- an upright position if possible; otherwise essary. choose that mode of transportation least 7. Open a loaded cassette momentarily at likely to jar the samples in transit. one of the indoor sampling sites when sam- 6. Address the package to the laboratory pling is initiated. This sample will serve as sample coordinator by name when known an indoor field blank. and alert him or her of the package descrip- 8. Open a loaded cassette momentarily at tion, shipment mode, and anticipated arrival one of the outdoor sampling sites when sam- as part of the chain of custody and sample pling is initiated. This sample will serve as tracking procedures. This will also help the an outdoor field blank. laboratory schedule timely analysis for the 9. Carry a sealed blank into the field with samples when they are received. each sample series. Do not open this cassette in the field. D. Quality Control/Quality Assurance 10. Perform a leak check of the sampling Procedures (Data Quality Indicators) system at each indoor and outdoor sampling Monitoring the environment for airborne site by activating the pump with the closed asbestos requires the use of sensitive sam- sampling cassette in line. Any flow indicates pling and analysis procedures. Because the a leak which must be eliminated before initi- test is sensitive, it may be influenced by a ating the sampling operation. variety of factors. These include the supplies 11. Ensure that the sampler is turned up- used in the sampling operation, the perform- right before interrupting the pump flow. ance of the sampling, the preparation of the 12. Check that all samples are clearly la- grid from the filter and the actual examina- beled and that all pertinent information has tion of this grid in the microscope. Each of been enclosed before transfer of the samples these unit operations must produce a prod- to the laboratory. uct of defined quality if the analytical result E. Sample Receiving is to be a reliable and meaningful test result. Accordingly, a series of control checks and 1. Designate one individual as sample coor- reference standards is performed along with dinator at the laboratory. While that indi- the sample analysis as indicators that the vidual will normally be available to receive materials used are adequate and the oper- samples, the coordinator may train and su- ations are within acceptable limits. In this pervise others in receiving procedures for way, the quality of the data is defined, and those times when he/she is not available. the results are of known value. These checks 2. Adhere to the following procedures to and tests also provide timely and specific ensure both the continued chain-of-custody warning of any problems which might de- and the accountability of all samples passing velop within the sampling and analysis oper- through the laboratory: ations. A description of these quality con- a. Note the condition of the shipping pack- trol/quality assurance procedures is summa- age and data written on it upon receipt. rized in the text below. b. Retain all bills of lading or shipping 1. Prescreen the loaded cassette collection slips to document the shipper and delivery filters to assure that they do not contain time. concentrations of asbestos which may inter- c. Examine the chain-of-custody seal, if fere with the analysis of the sample. A filter any, and the package for its integrity. blank average of less than 18 s/mm2 in an d. If there has been a break in the seal or area of 0.057 mm2 (nominally 10 200-mesh grid substantive damage to the package, the sam- openings) and a maximum of 53 s/mm2 for ple coordinator shall immediately notify the that same area for any single preparation is shipper and a responsible laboratory man- acceptable for this method. ager before any action is taken to unpack 2. Calibrate sampling pumps and their flow the shipment. indicators over the range of their intended e. Packages with significant damage shall use with a recognized standard. Assemble the be accepted only by the responsible labora- sampling system with a representative fil- tory manager after discussions with the cli- ter—not the filter which will be used in sam- ent. pling—before and after the sampling oper- 3. Unwrap the shipment in a clean, ation. uncluttered facility. The sample coordinator 3. Record all calibration information with or his or her designee will record the con- the data to be used on a standard sampling tents, including a description of each item form. and all identifying numbers or marks. A

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Sample Receiving Form to document this information is attached for use when necessary. (See the following Figure 3.)

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NOTE: The person breaking the chain-of- f. Store the three grids to be measured in custody seal and itemizing the contents as- appropriately labeled grid holders or poly- sumes responsibility for the shipment and ethylene capsules. signs documents accordingly. 5. Equipment. 4. Assign a laboratory number and sched- a. Clean area. ule an analysis sequence. b. Tweezers. Fine-point tweezers for han- 5. Manage all chain-of-custody samples dling of filters and TEM grids. within the laboratory such that their integ- c. Scalpel Holder and Curved No. 10 Sur- rity can be ensured and documented. gical Blades. d. Microscope slides. F. Sample Preparation e. Double-coated adhesive tape. f. Gummed page reinforcements. 1. Personnel not affiliated with the Abate- g. Micro-pipet with disposal tips 10 to 100 ment Contractor shall be used to prepare μL variable volume. samples and conduct TEM analysis. Wet- h. Vacuum coating unit with facilities for wipe the exterior of the cassettes to mini- evaporation of carbon. Use of a liquid nitro- mize contamination possibilities before tak- gen cold trap above the diffusion pump will ing them to the clean sample preparation fa- minimize the possibility of contamination of cility. the filter surface by oil from the pumping 2. Perform sample preparation in a well- system. The vacuum-coating unit can also be equipped clean facility. used for deposition of a thin film of gold. NOTE: The clean area is required to have i. Carbon rod electrodes. Spectrochemically the following minimum characteristics. The pure carbon rods are required for use in the area or hood must be capable of maintaining vacuum evaporator for carbon coating of fil- a positive pressure with make-up air being ters. HEPA filtered. The cumulative analytical j. Carbon rod sharpener. This is used to blank concentration must average less than sharpen carbon rods to a neck. The use of 18 s/mm2 in an area of 0.057 s/mm2 (nominally necked carbon rods (or equivalent) allows 10 200-mesh grid openings) with no more than the carbon to be applied to the filters with a one single preparation to exceed 53 s/mm2 for minimum of heating. that same area. k. Low-temperature plasma asher. This is 3. Preparation areas for air samples must used to etch the surface of collapsed mixed be separated from preparation areas for bulk cellulose ester (MCE) filters. The asher samples. Personnel must not prepare air should be supplied with oxygen, and should samples if they have previously been pre- be modified as necessary to provide a throt- paring bulk samples without performing ap- tle or bleed valve to control the speed of the propriate personal hygiene procedures, i.e., vacuum to minimize disturbance of the fil- clothing change, showering, etc. ter. Some early models of ashers admit air 4. Preparation. Direct preparation tech- too rapidly, which may disturb particulates niques are required. The objective is to on the surface of the filter during the etch- produce an intact carbon film containing the ing step. particulates from the filter surface which is l. Glass petri dishes, 10 cm in diameter, 1 cm sufficiently clear for TEM analysis. Cur- high. For prevention of excessive evaporation rently recommended direct preparation proof solvent when these are in use, a good seal cedures for polycarbonate (PC) and mixed must be provided between the base and the cellulose ester (MCE) filters are described in lid. The seal can be improved by grinding the Unit III.F.7. and 8. Sample preparation is a base and lid together with an abrasive grind- subject requiring additional research. Vari- ing material. ation on those steps which do not sub- m. Stainless steel mesh. stantively change the procedure, which im- n. Lens tissue. prove filter clearing or which reduce con- o. Copper 200-mesh TEM grids, 3 mm in di- tamination problems in a laboratory are per- ameter, or equivalent. mitted. p. Gold 200-mesh TEM grids, 3 mm in diameter, or equivalent. a. Use only TEM grids that have had grid q. Condensation washer. opening areas measured according to direc- r. Carbon-coated, 200-mesh TEM grids, or tions in Unit III.J. equivalent. b. Remove the inlet and outlet plugs prior s. Analytical balance, 0.1 mg sensitivity. to opening the cassette to minimize any t. Filter paper, 9 cm in diameter. pressure differential that may be present. u. Oven or slide warmer. Must be capable c. Examples of techniques used to prepare of maintaining a temperature of 65–70 °C. polycarbonate filters are described in Unit v. Polyurethane foam, 6 mm thickness. III.F.7. w. Gold wire for evaporation. d. Examples of techniques used to prepare 6. Reagents. mixed cellulose ester filters are described in a. General. A supply of ultra-clean, fiber- Unit III.F.8. free water must be available for washing of e. Prepare multiple grids for each sample. all components used in the analysis. Water

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that has been distilled in glass or filtered or strips on the same microscope slide, taking deionized water is satisfactory for this pur- care to rinse and wet-wipe the scalpel blade pose. Reagents must be fiber-free. and tweezers before handling a new sample. b. Polycarbonate preparation method— The filter strips should be identified by etch- chloroform. ing the glass slide or marking the slide using c. Mixed Cellulose Ester (MCE) preparation a marker insoluble in water and solvents. method—acetone or the Burdette procedure After the filter strip has been cut from each (Ref. 7 of Unit III.L.). filter, the residual parts of the filter must be 7. TEM specimen preparation from returned to the cassette and held in position polycarbonate filters. by reassembly of the cassette. The cassette a. Specimen preparation laboratory. It is will then be archived for a period of 30 days most important to ensure that contamina- or returned to the client upon request. tion of TEM specimens by extraneous asbes- e. Carbon coating of filter strips. The glass tos fibers is minimized during preparation. slide holding the filter strips is placed on the b. Cleaning of sample cassettes. Upon re- rotation-tilting device, and the evaporator ceipt at the analytical laboratory and before chamber is evacuated. The evaporation must they are taken into the clean facility or lam- be performed in very short bursts, separated inar flow hood, the sample cassettes must be by some seconds to allow the electrodes to cleaned of any contamination adhering to cool. If evaporation is too rapid, the strips of the outside surfaces. polycarbonate filter will begin to curl, which c. Preparation of the carbon evaporator. If will lead to cross-linking of the surface ma- the polycarbonate filter has already been terial and make it relatively insoluble in carbon-coated prior to receipt, the carbon chloroform. An experienced analyst can coating step will be omitted, unless the ana- judge the thickness of carbon film to be ap- lyst believes the carbon film is too thin. If plied, and some test should be made first on there is a need to apply more carbon, the fil- unused filters. If the film is too thin, large ter will be treated in the same way as an particles will be lost from the TEM speci- uncoated filter. Carbon coating must be per- men, and there will be few complete and formed with a high-vacuum coating unit. undamaged grid openings on the specimen. If Units that are based on evaporation of car- the coating is too thick, the filter will tend bon filaments in a vacuum generated only by to curl when exposed to chloroform vapor an oil rotary pump have not been evaluated and the carbon film may not adhere to the for this application, and must not be used. support mesh. Too thick a carbon film will The carbon rods should be sharpened by a also lead to a TEM image that is lacking in carbon rod sharpener to necks of about 4 mm contrast, and the ability to obtain ED pat- long and 1 mm in diameter. The rods are in- terns will be compromised. The carbon film stalled in the evaporator in such a manner should be as thin as possible and remain in- that the points are approximately 10 to 12 tact on most of the grid openings of the TEM cm from the surface of a microscope slide specimen intact. held in the rotating and tilting device. f. Preparation of the Jaffe washer. The pre- d. Selection of filter area for carbon coat- cise design of the Jaffe washer is not consid- ing. Before preparation of the filters, a 75 ered important, so any one of the published mm×50 mm microscope slide is washed and designs may be used. A washer consisting of dried. This slide is used to support strips of a simple stainless steel bridge is rec- filter during the carbon evaporation. Two ommended. Several pieces of lens tissue ap- parallel strips of double-sided adhesive tape proximately 1.0 cm×0.5 cm are placed on the are applied along the length of the slide. stainless steel bridge, and the washer is Polycarbonate filters are easily stretched filled with chloroform to a level where the during handling, and cutting of areas for fur- meniscus contacts the underside of the mesh, ther preparation must be performed with which results in saturation of the lens tis- great care. The filter and the MCE backing sue. See References 8 and 10 of Unit III.L. filter are removed together from the cassette g. Placing of specimens into the Jaffe and placed on a cleaned glass microscope washer. The TEM grids are first placed on a slide. The filter can be cut with a curved piece of lens tissue so that individual grids scalpel blade by rocking the blade from the can be picked up with tweezers. Using a point placed in contact with the filter. The curved scalpel blade, the analyst excises process can be repeated to cut a strip ap- three 3 mm square pieces of the carbon-coat- proximately 3 mm wide across the diameter ed polycarbonate filter from the filter strip. of the filter. The strip of polycarbonate filter The three squares are selected from the cen- is separated from the corresponding strip of ter of the strip and from two points between backing filter and carefully placed so that it the outer periphery of the active surface and bridges the gap between the adhesive tape the center. The piece of filter is placed on a strips on the microscope slide. The filter TEM specimen grid with the shiny side of strip can be held with fine-point tweezers the TEM grid facing upwards, and the whole and supported underneath by the scalpel assembly is placed boldly onto the saturated blade during placement on the microscope lens tissue in the Jaffe washer. If carbon- slide. The analyst can place several such coated grids are used, the filter should be

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placed carbon-coated side down. The three the conditions that should be used. This is excised squares of filters are placed on the one area of the method that requires further same piece of lens tissue. Any number of sep- evaluation. Insufficient etching will result in arate pieces of lens tissue may be placed in a failure to expose embedded filters, and too the same Jaffe washer. The lid is then placed much etching may result in loss of particu- on the Jaffe washer, and the system is al- late from the surface. As an interim meas- lowed to stand for several hours, preferably ure, it is recommended that the time for overnight. ashing of a known weight of a collapsed fil- h. Condensation washing. It has been found ter be established and that the etching rate that many polycarbonate filters will not dis- be calculated in terms of micrometers per solve completely in the Jaffe washer, even second. The actual etching time used for a after being exposed to chloroform for as long particular asher and operating conditions as 3 days. This problem becomes more seri- will then be set such that a 1–2 μm (10 per- ous if the surface of the filter was overheated cent) layer of collapsed surface will be re- during the carbon evaporation. The presence moved. of undissolved filter medium on the TEM ii. Place the slide containing the collapsed preparation leads to partial or complete ob- filters into a low-temperature plasma asher, scuration of areas of the sample, and fibers and etch the filter. that may be present in these areas of the g. Transfer the slide to a rotating stage in- specimen will be overlooked; this will lead to side the bell jar of a vacuum evaporator. a low result. Undissolved filter medium also Evaporate a 1 mm×5 mm section of graphite compromises the ability to obtain ED pat- rod onto the cleared filter. Remove the slide terns. Before they are counted, TEM grids to a clean, dry, covered petri dish. must be examined critically to determine h. Prepare a second petri dish as a Jaffe whether they are adequately cleared of resid- washer with the wicking substrate prepared ual filter medium. It has been found that from filter or lens paper placed on top of a 6 condensation washing of the grids after the mm thick disk of clean spongy polyurethane initial Jaffe washer treatment, with chloro- foam. Cut a V-notch on the edge of the foam form as the solvent, clears all residual filter and filter paper. Use the V-notch as a res- medium in a period of approximately 1 hour. ervoir for adding solvent. The wicking sub- In practice, the piece of lens tissue sup- strate should be thin enough to fit into the porting the specimen grids is transferred to petri dish without touching the lid. the cold finger of the condensation washer, i. Place carbon-coated TEM grids face up and the washer is operated for about 1 hour. on the filter or lens paper. Label the grids by If the specimens are cleared satisfactorily by marking with a pencil on the filter paper or the Jaffe washer alone, the condensation by putting registration marks on the petri washer step may be unnecessary. dish lid and marking with a waterproof 8. TEM specimen preparation from MCE marker on the dish lid. In a fume hood, fill filters. the dish with acetone until the wicking sub- a. This method of preparing TEM speci- strate is saturated. The level of acetone mens from MCE filters is similar to that should be just high enough to saturate the specified in NIOSH Method 7402. See Ref- filter paper without creating puddles. erences 7, 8, and 9 of Unit III.L. j. Remove about a quarter section of the b. Upon receipt at the analytical labora- carbon-coated filter samples from the glass tory, the sample cassettes must be cleaned of slides using a surgical knife and tweezers. any contamination adhering to the outside Carefully place the section of the filter, car- surfaces before entering the clean sample bon side down, on the appropriately labeled preparation area. grid in the acetone-saturated petri dish. c. Remove a section from any quadrant of When all filter sections have been trans- the sample and blank filters. ferred, slowly add more solvent to the wedge- d. Place the section on a clean microscope shaped trough to bring the acetone level up slide. Affix the filter section to the slide to the highest possible level without dis- with a gummed paged reinforcement or other turbing the sample preparations. Cover the suitable means. Label the slide with a water petri dish. Elevate one side of the petri dish and solvent-proof marking pen. by placing a slide under it. This allows drops e. Place the slide in a petri dish which con- of condensed solvent vapors to form near the tains several paper filters soaked with 2 to 3 edge rather than in the center where they mL acetone. Cover the dish. Wait 2 to 4 min- would drip onto the grid preparation. utes for the sample filter to fuse and clear. G. TEM Method f. Plasma etching of the collapsed filter is required. 1. Instrumentation. i. The microscope slide to which the col- a. Use an 80–120 kV TEM capable of per- lapsed filter pieces are attached is placed in forming electron diffraction with a fluores- a plasma asher. Because plasma ashers vary cent screen inscribed with calibrated grada- greatly in their performance, both from unit tions. If the TEM is equipped with EDXA it to unit and between different positions in must either have a STEM attachment or be the asher chamber, it is difficult to specify capable of producing a spot less than 250 nm

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in diameter at crossover. The microscope i. Standard replica grating may be used to shall be calibrated routinely (see Unit III.J.) determine magnification (e.g., 2160 lines/ for magnification and camera constant. mm). b. While not required on every microscope ii. Gold standard may be used to determine in the laboratory, the laboratory must have camera constant. either one microscope equipped with energy c. Use a specimen holder with single tilt dispersive X-ray analysis or access to an and/or double tilt capabilities. equivalent system on a TEM in another lab- 2. Procedure. oratory. This must be an Energy Dispersive a. Start a new Count Sheet for each sample X-ray Detector mounted on TEM column and to be analyzed. Record on count sheet: ana- associated hardware/software to collect, lyst’s initials and date; lab sample number; save, and read out spectral information. client sample number microscope identifica- Calibration of Multi-Channel Analyzer shall tion; magnification for analysis; number of be checked regularly for A1 at 1.48 KeV and predetermined grid openings to be analyzed; Cu at 8.04 KeV, as well as the manufacturer’s and grid identification. See the following procedures. Figure 4:

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b. Check that the microscope is properly d. Approximately one-half (0.5) of the pre- aligned and calibrated according to the man- determined sample area to be analyzed shall ufacturer’s specifications and instructions. be performed on one sample grid preparation c. Microscope settings: 80–120 kV, grid as- and the remaining half on a second sample sessment 250–1000X, then 15,000–20,000X grid preparation. screen magnification for analysis. e. Determine the suitability of the grid.

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i. Individual grid openings with greater loaded into the microscope and a particular than 5 percent openings (holes) or covered field is to be reliably identified. with greater than 25 percent particulate g. Scan the grid. matter or obviously having nonuniform load- i. Select a field to start the examination. ing shall not be analyzed. ii. Choose the appropriate magnification ii. Examine the grid at low magnification (15,000 to 20,000X screen magnification). (<1000X) to determine its suitability for de- iii. Scan the grid as follows. tailed study at higher magnifications. (1) At the selected magnification, make a iii. Reject the grid if: series of parallel traverses across the field. (1) Less than 50 percent of the grid open- On reaching the end of one traverse, move ings covered by the replica are intact. the image one window and reverse the tra- (2) It is doubled or folded. verse. (3) It is too dark because of incomplete dis- NOTE: A slight overlap should be used so as solution of the filter. not to miss any part of the grid opening iv. If the grid is rejected, load the next (field). sample grid. (2) Make parallel traverses until the entire v. If the grid is acceptable, continue on to grid opening (field) has been scanned. Step 6 if mapping is to be used; otherwise h. Identify each structure for appearance proceed to Step 7. and size. f. Grid Map (Optional). i. Appearance and size: Any continuous i. Set the TEM to the low magnification grouping of particles in which an asbestos mode. fiber within aspect ratio greater than or ii. Use flat edge or finder grids for map- equal to 5:1 and a length greater than or ping. equal to 0.5 μm is detected shall be recorded iii. Index the grid openings (fields) to be on the count sheet. These will be designated counted by marking the acceptable fields for asbestos structures and will be classified as one-half (0.5) of the area needed for analysis fibers, bundles, clusters, or matrices. Record on each of the two grids to be analyzed. as individual fibers any contiguous grouping These may be marked just before examining having 0, 1, or 2 definable intersections. each grid opening (field), if desired. Groupings having more than 2 intersections iv. Draw in any details which will allow are to be described as cluster or matrix. See the grid to be properly oriented if it is re- the following Figure 5:

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An intersection is a non-parallel touching or (1) Fiber. A structure having a minimum crossing of fibers, with the projection having length greater than 0.5 μm and an aspect an aspect ratio of 5:1 or greater. Combina- ratio (length to width) of 5:1 or greater and tions such as a matrix and cluster, matrix substantially parallel sides. Note the appear- and bundle, or bundle and cluster are cat- ance of the end of the fiber, i.e., whether it egorized by the dominant fiber quality—clus- is flat, rounded or dovetailed, no intersec- ter, bundle, and matrix, respectively. Sepa- tions. rate categories will be maintained for fibers (2) Bundle. A structure composed of 3 or less than 5 μm and for fibers greater than or more fibers in a parallel arrangement with each fiber closer than one fiber diameter. equal to 5 μm in length. Not required, but (3) Cluster. A structure with fibers in a ran- useful, may be to record the fiber length in dom arrangement such that all fibers are 1 μm intervals. (Identify each structure intermixed and no single fiber is isolated morphologically and analyze it as it enters from the group; groupings must have more the ‘‘window’’.) than 2 intersections.

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(4) Matrix. Fiber or fibers with one end free iii. The micrograph number of the recorded and the other end embedded in or hidden by diffraction patterns must be reported to the a particulate. The exposed fiber must meet client and maintained in the laboratory’s the fiber definition. quality assurance records. The records must (5) NSD. Record NSD when no structures also demonstrate that the identification of are detected in the field. the pattern has been verified by a qualified (6) Intersection. Non-parallel touching or individual and that the operator who made crossing of fibers, with the projection having the identification is maintaining at least an an aspect ratio 5:1 or greater. 80 percent correct visual identification based ii. Structure Measurement. on his measured patterns. In the event that (1) Recognize the structure that is to be examination of the pattern by the qualified sized. individual indicates that the pattern had (2) Memorize its location in the ‘‘window’’ been misidentified visually, the client shall relative to the sides, inscribed square and to be contacted. If the pattern is a suspected other particulates in the field so this exact chrysotile, take a photograph of the diffrac- location can be found again when scanning is tion pattern at 0 degrees tilt. If the structure resumed. is suspected to be amphibole, the sample (3) Measure the structure using the scale may have to be tilted to obtain a simple geo- on the screen. metric array of spots. (4) Record the length category and struc- j. Energy Dispersive X-Ray Analysis ture type classification on the count sheet (EDXA). after the field number and fiber number. i. Required of all amphiboles which would (5) Return the fiber to its original location cause the analysis results to exceed the 70 s/ in the window and scan the rest of the field mm2 concentration. (Generally speaking, the for other fibers; if the direction of travel is first 4 amphiboles would require EDXA.) not remembered, return to the right side of ii. Can be used alone to confirm chrysotile the field and begin the traverse again. after the 70 s/mm2 concentration has been ex- i. Visual identification of Electron Diffrac- ceeded. tion (ED) patterns is required for each asbes- iii. Can be used alone to confirm all non- tos structure counted which would cause the asbestos. analysis to exceed the 70 s/mm2 concentra- iv. Compare spectrum profiles with profiles tion. (Generally this means the first four fi- obtained from asbestos standards. The clos- bers identified as asbestos must exhibit an est match identifies and categorizes the identifiable diffraction pattern for chrysotile structure. or amphibole.) v. If the EDXA is used for confirmation, i. Center the structure, focus, and obtain record the properly labeled spectrum on a an ED pattern. (See Microscope Instruction computer disk, or if a hard copy, file with Manual for more detailed instructions.) analysis data. ii. From a visual examination of the ED vi. If the number of fibers in the non- pattern, obtained with a short camera asbestos class would cause the analysis to length, classify the observed structure as be- exceed the 70 s/mm2 concentration, their longing to one of the following classifica- identities must be confirmed by EDXA or tions: chrysotile, amphibole, or nonasbestos. measurement of a zone axis diffraction pat- (1) Chrysotile: The chrysotile asbestos pattern to establish that the particles are non- tern has characteristic streaks on the layer asbestos. lines other than the central line and some k. Stopping Rules. streaking also on the central line. There will i. If more than 50 asbestiform structures be spots of normal sharpness on the central are counted in a particular grid opening, the layer line and on alternate lines (2nd, 4th, analysis may be terminated. etc.). The repeat distance between layer lines ii. After having counted 50 asbestiform is 0.53 nm and the center doublet is at 0.73 structures in a minimum of 4 grid openings, nm. The pattern should display (002), (110), the analysis may be terminated. The grid (130) diffraction maxima; distances and ge- opening in which the 50th fiber was counted ometry should match a chrysotile pattern must be completed. and be measured semiquantitatively. iii. For blank samples, the analysis is al- (2) Amphibole Group [includes grunerite ways continued until 10 grid openings have (amosite), crocidolite, anthophyllite, been analyzed. tremolite, and actinolite]: Amphibole asbes- iv. In all other samples the analysis shall tos fiber patterns show layer lines formed by be continued until an analytical sensitivity very closely spaced dots, and the repeat dis- of 0.005 s/cm3 is reached. tance between layer lines is also about 0.53 l. Recording Rules. The count sheet should nm. Streaking in layer lines is occasionally contain the following information: present due to crystal structure defects. i. Field (grid opening): List field number. (3) Nonasbestos: Incomplete or ii. Record ‘‘NSD’’ if no structures are de- unobtainable ED patterns, a nonasbestos tected. EDXA, or a nonasbestos morphology. iii. Structure information.

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(1) If fibers, bundles, clusters, and/or mat- from the group. Groupings must have more rices are found, list them in consecutive nu- than two intersections. merical order, starting over with each field. iv. Matrix. Fiber or fibers with one end free (2) Length. Record length category of as- and the other end embedded in or hidden by bestos fibers examined. Indicate if less than a particulate. The exposed fiber must meet 5 μm or greater than or equal to 5 μm. the fiber definition. (3) Structure Type. Positive identification v. NSD. Record NSD when no structures of asbestos fibers is required by the method. are detected in the field. At least one diffraction pattern of each fiber n. After all necessary analyses of a particle type from every five samples must be re- structure have been completed, return the corded and compared with a standard diffrac- goniometer stage to 0 degrees, and return tion pattern. For each asbestos fiber re- the structure to its original location by reported, both a morphological descriptor and call of the original location. an identification descriptor shall be specified o. Continue scanning until all the struc- on the count sheet. tures are identified, classified and sized in (4) Fibers classified as chrysotile must be the field. identified by diffraction and/or X-ray anal- p. Select additional fields (grid openings) ysis and recorded on the count sheet. X-ray analysis alone can be used as sole identifica- at low magnification; scan at a chosen magnification (15,000 to 20,000X screen magnification only after 70s/mm2 have been exceeded for a particular sample. tion); and analyze until the stopping rule be- (5) Fibers classified as amphiboles must be comes applicable. identified by X-ray analysis and electron dif- q. Carefully record all data as they are fraction and recorded on the count sheet. (X- being collected, and check for accuracy. ray analysis alone can be used as sole identi- r. After finishing with a grid, remove it fication only after 70s/mm2 have been exceed- from the microscope, and replace it in the ed for a particular sample.) appropriate grid hold. Sample grids must be (6) If a diffraction pattern was recorded on stored for a minimum of 1 year from the date film, the micrograph number must be indi- of the analysis; the sample cassette must be cated on the count sheet. retained for a minimum of 30 days by the (7) If an electron diffraction was attempted laboratory or returned at the client’s re- and an appropriate spectra is not observed, N quest. should be recorded on the count sheet. (8) If an X-ray analysis is attempted but H. Sample Analytical Sequence not observed, N should be recorded on the 1. Carry out visual inspection of work site count sheet. prior to air monitoring. (9) If an X-ray analysis spectrum is stored, 2. Collect a minimum of five air samples the file and disk number must be recorded on inside the work site and five samples outside the count sheet. the work site. The indoor and outdoor sam- m. Classification Rules. ples shall be taken during the same time pe- i. Fiber. A structure having a minimum riod. length greater than or equal to 0.5 μm and an 3. Analyze the abatement area samples ac- aspect ratio (length to width) of 5:1 or great- cording to this protocol. The analysis must er and substantially parallel sides. Note the meet the 0.005 s/cm3 analytical sensitivity. appearance of the end of the fiber, i.e., whether it is flat, rounded or dovetailed. 4. Remaining steps in the analytical se- ii. Bundle. A structure composed of three quence are contained in Unit IV. of this Ap- or more fibers in a parallel arrangement pendix. with each fiber closer than one fiber diame- I. Reporting ter. iii. Cluster. A structure with fibers in a The following information must be re- random arrangement such that all fibers are ported to the client. See the following Table intermixed and no single fiber is isolated II:

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1. Concentration in structures per square 5. Volume of air samples (which was ini- millimeter and structures per cubic centi- tially provided by client). meter. 6. Average grid size opening. 2. Analytical sensitivity used for the anal- 7. Number of grids analyzed. ysis. 8. Copy of the count sheet must be included 3. Number of asbestos structures. with the report. 4. Area analyzed.

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9. Signature of laboratory official to indi- calculation. On most microscopes, however, cate that the laboratory met specifications the magnification is substantially constant of the AHERA method. only within the central 8–10 cm diameter re- 10. Report form must contain official lab- gion of the fluorescent screen. oratory identification (e.g., letterhead). iv. Calculate the true magnification (M) on 11. Type of asbestos. the fluorescent screen: M=XG/Y J. Calibration Methodology where: NOTE: Appropriate implementation of the X=total distance (mm) between the des- method requires a person knowledgeable in ignated grating lines; electron diffraction and mineral identifica- G=calibration constant of the grating replica tion by ED and EDXA. Those inexperienced (lines/mm): laboratories wishing to develop capabilities Y=number of grating replica spaces counted may acquire necessary knowledge through along X. analysis of appropriate standards and by following detailed methods as described in Ref- c. Calibration of the EDXA System. Ini- erences 8 and 10 of Unit III.L. tially, the EDXA system must be calibrated 1. Equipment Calibration. In this method, by using two reference elements to calibrate calibration is required for the air-sampling the energy scale of the instrument. When equipment and the transmission electron mi- this has been completed in accordance with croscope (TEM). the manufacturer’s instructions, calibration a. TEM Magnification. The magnification at in terms of the different types of asbestos the fluorescent screen of the TEM must be can proceed. The EDXA detectors vary in calibrated at the grid opening magnification both solid angle of detection and in window (if used) and also at the magnification used thickness. Therefore, at a particular accel- for fiber counting. This is performed with a erating voltage in use on the TEM, the count cross grating replica. A logbook must be rate obtained from specific dimensions of maintained, and the dates of calibration de- fiber will vary both in absolute X-ray count pend on the past history of the particular rate and in the relative X-ray peak heights microscope; no frequency is specified. After for different elements. Only a few minerals any maintenance of the microscope that in- are relevant for asbestos abatement work, volved adjustment of the power supplied to and in this procedure the calibration is spec- the lenses or the high-voltage system or the ified in terms of a ‘‘fingerprint’’ technique. mechanical disassembly of the electron opti- The EDXA spectra must be recorded from in- cal column apart from filament exchange, dividual fibers of the relevant minerals, and the magnification must be recalibrated. Be- identifications are made on the basis of fore the TEM calibration is performed, the semiquantitative comparisons with these analyst must ensure that the cross grating reference spectra. replica is placed at the same distance from d. Calibration of Grid Openings. the objective lens as the specimens are. For i. Measure 20 grid openings on each of 20 instruments that incorporate an eucentric random 200-mesh copper grids by placing a tilting specimen stage, all speciments and grid on a glass slide and examining it under the cross grating replica must be placed at the PCM. Use a calibrated graticule to meas- the eucentric position. ure the average field diameter and use this b. Determination of the TEM magnifica- number to calculate the field area for an av- tion on the fluorescent screen. erage grid opening. Grids are to be randomly i. Define a field of view on the fluorescent selected from batches up to 1,000. screen either by markings or physical bound- NOTE: A grid opening is considered as one aries. The field of view must be measurable field. or previously inscribed with a scale or con- ii. The mean grid opening area must be centric circles (all scales should be metric). measured for the type of specimen grids in ii. Insert a diffraction grating replica (for use. This can be accomplished on the TEM at example a grating containing 2,160 lines/mm) a properly calibrated low magnification or into the specimen holder and place into the on an optical microscope at a magnification microscope. Orient the replica so that the of approximately 400X by using an eyepiece grating lines fall perpendicular to the scale fitted with a scale that has been calibrated on the TEM fluorescent screen. Ensure that against a stage micrometer. Optical micros- the goniometer stage tilt is 0 degrees. copy utilizing manual or automated proce- iii. Adjust microscope magnification to dures may be used providing instrument cali- 10,000X or 20,000X. Measure the distance bration can be verified. (mm) between two widely separated lines on e. Determination of Camera Constant and the grating replica. Note the number of ED Pattern Analysis. spaces between the lines. Take care to meas- i. The camera length of the TEM in ED op- ure between the same relative positions on erating mode must be calibrated before ED the lines (e.g., between left edges of lines). patterns on unknown samples are observed. NOTE: The more spaces included in the This can be achieved by using a carbon-coat- measurement, the more accurate the final ed grid on which a thin film of gold has been

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sputtered or evaporated. A thin film of gold pling and analysis procedures. Because the is evaporated on the specimen TEM grid to test is sensitive, it may be influenced by a obtain zone-axis ED patterns superimposed variety of factors. These include the supplies with a ring pattern from the polycrystalline used in the sampling operation, the perform- gold film. ance of the sampling, the preparation of the ii. In practice, it is desirable to optimize grid from the filter and the actual examina- the thickness of the gold film so that only tion of this grid in the microscope. Each of one or two sharp rings are obtained on the these unit operations must produce a prod- superimposed ED pattern. Thicker gold film uct of defined quality if the analytical result would normally give multiple gold rings, but it will tend to mask weaker diffraction spots is to be a reliable and meaningful test result. from the unknown fibrous particulates. Accordingly, a series of control checks and Since the unknown d-spacings of most inter- reference standards is performed along with est in asbestos analysis are those which lie the sample analysis as indicators that the closest to the transmitted beam, multiple materials used are adequate and the oper- gold rings are unnecessary on zone-axis ED ations are within acceptable limits. In this patterns. An average camera constant using way, the quality of the data is defined and multiple gold rings can be determined. The the results are of known value. These checks camera constant is one-half the diameter, D, and tests also provide timely and specific of the rings times the interplanar spacing, d, warning of any problems which might de- of the ring being measured. velop within the sampling and analysis operations. A description of these quality con- K. Quality Control/Quality Assurance Procedures (Data Quality Indicators) trol/quality assurance procedures is summarized in the following Table III: Monitoring the environment for airborne asbestos requires the use of sensitive sam-

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1. When the samples arrive at the labora- 5. Provide laboratory blanks with each tory, check the samples and documentation sample batch. Maintain a cumulative aver- for completeness and requirements before age of these results. If this average is greater initiating the analysis. than 53 f/mm2 per 10 200-mesh grid openings, 2. Check all laboratory reagents and sup- check the system for possible sources of con- plies for acceptable asbestos background lev- tamination. els. 6. Check for recovery of asbestos from cel- 3. Conduct all sample preparation in a lulose ester filters submitted to plasma clean room environment monitored by lab- asher. oratory blanks and special testing after 7. Check for asbestos carryover in the plas- cleaning or servicing the room. ma asher by including a blank alongside the 4. Prepare multiple grids of each sample. positive control sample.

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8. Perform a systems check on the trans- tron Microscopy Using Polycarbonate Mem- mission electron microscope daily. brane Filters.’’ WERL SOP 87–1, March 5, 9. Make periodic performance checks of 1987. magnification, electron diffraction and en- 9. NIOSH. Method 7402 for Asbestos Fibers, ergy dispersive X-ray systems as set forth in December 11, 1986 Draft. Table III of Unit III.K. 10. Yamate, G., S.C. Agarwall, R.D. Gib- 10. Ensure qualified operator performance bons, IIT Research Institute, ‘‘Methodology by evaluation of replicate counting, dupli- for the Measurement of Airborne Asbestos by cate analysis, and standard sample compari- Electron Microscopy.’’ Draft report, USEPA sons as set forth in Table III of Unit III.K. Contract 68–02–3266, July 1984. 11. Validate all data entries. 11. Guidance to the Preparation of Quality 12. Recalculate a percentage of all com- Assurance Project Plans. USEPA, Office of putations and automatic data reduction Pollution Prevention and Toxics, 1984. steps as specified in Table III. 13. Record an electron diffraction pattern IV. Mandatory Interpretation of Transmission of one asbestos structure from every five Electron Microscopy Results To Determine samples that contain asbestos. Verify the Completion of Response Actions identification of the pattern by measure- A. Introduction ment or comparison of the pattern with patterns collected from standards under the A response action is determined to be com- same conditions. pleted by TEM when the abatement area has been cleaned and the airborne asbestos con- The outline of quality control procedures centration inside the abatement area is no presented above is viewed as the minimum higher than concentrations at locations out- required to assure that quality data is pro- side the abatement area. ‘‘Outside’’ means duced for clearance testing of an asbestos outside the abatement area, but not nec- abated area. Additional information may be essarily outside the building. EPA reasons gained by other control tests. Specifics on that an asbestos removal contractor cannot those control procedures and options avail- be expected to clean an abatement area to an able for environmental testing can be ob- airborne asbestos concentration that is tained by consulting References 6, 7, and 11 lower than the concentration of air entering of Unit III.L. the abatement area from outdoors or from L. References other parts of the building. After the abatement area has passed a thorough visual in- For additional background information on spection, and before the outer containment this method the following references should barrier is removed, a minimum of five air be consulted. samples inside the abatement area and a 1. ‘‘Guidelines for Controlling Asbestos- minimum of five air samples outside the Containing Materials in Buildings,’’ EPA 560/ abatement area must be collected. Hence, 5–85–024, June 1985. the response action is determined to be com- 2. ‘‘Measuring Airborne Asbestos Following pleted when the average airborne asbestos an Abatement Action,’’ USEP/Office of Pol- concentration measured inside the abate- lution Prevention and Toxics, EPA 600/4–85– ment area is not statistically different from 049, 1985. the average airborne asbestos concentration 3. Small, John and E. Steel. Asbestos measured outside the abatement area. Standards: Materials and Analytical Meth- The inside and outside concentrations are ods. N.B.S. Special Publication 619, 1982. compared by the Z-test, a statistical test 4. Campbell, W.J., R.L. Blake, L.L. Brown, that takes into account the variability in E.E. Cather, and J.J. Sjoberg. Selected Sili- the measurement process. A minimum of cate Minerals and Their Asbestiform Vari- five samples inside the abatement area and eties. Information Circular 8751, U.S. Bureau five samples outside the abatement area are of Mines, 1977. required to control the false negative error 5. Quality Assurance Handbook for Air Pol- rate, i.e., the probability of declaring the re- lution Measurement System. Ambient Air moval complete when, in fact, the air con- Methods, EPA 600/4–77–027a, USEPA, Office of centration inside the abatement area is sig- Research and Development, 1977. nificantly higher than outside the abatement 6. Method 2A: Direct Measurement of Gas area. Additional quality control is provided Volume Through Pipes and Small Ducts. 40 by requiring three blanks (filters through CFR Part 60 Appendix A. which no air has been drawn) to be analyzed 7. Burdette, G.J. Health & Safety Exec., to check for unusually high filter contami- Research & Lab. Services Div., London, nation that would distort the test results. ‘‘Proposed Analytical Method for Determina- When volumes greater than or equal to tion of Asbestos in Air.’’ 1,199 L for a 25 mm filter and 2,799 L for a 37 8. Chatfield, E.J., Chatfield Tech. Cons., mm filter have been collected and the aver- Ltd., Clark, T., PEI Assoc. ‘‘Standard Oper- age number of asbestos structures on sam- ating Procedure for Determination of Air- ples inside the abatement area is no greater borne Asbestos Fibers by Transmission Elec- than 70 s/mm2 of filter, the response action

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may be considered complete without com- centration on the blank fil- paring the inside samples to the outside sam- ters that is less than or equal to 70 s/mm2 and ples. EPA is permitting this initial screening the average airborne asbestos concentration test to save analysis costs in situations measured inside the abatement area is not where the airborne asbestos concentration is statistically higher than the average air- sufficiently low so that it cannot be distin- borne asbestos concentration measured out- guished from the filter contamination/back- side the abatement area as determined by ground level (fibers deposited on the filter the Z-test. The Z-test is carried out by calcu- that are unrelated to the air being sampled). lating The screening test cannot be used when volumes of less than 1,199 L for 25 mm filter or 2,799 L for a 37 mm filter are collected because the ability to distinguish levels significantly different from filter background is reduced at low volumes. The initial screening test is expressed in structures per square millimeter of filter be- where YI is the average of the natural loga- cause filter background levels come from rithms of the inside samples and YO is the sources other than the air being sampled and average of the natural logarithms of the out- cannot be meaningfully expressed as a con- side samples, nI is the number of inside sam- centration per cubic centimeter of air. The ples and nO is the number of outside samples. value of 70 s/mm2 is based on the experience The response action is considered complete if of the panel of microscopists who consider Z is less than or equal to 1.65. one structure in 10 grid openings (each grid NOTE: When no fibers are counted, the cal- opening with an area of 0.0057 mm2) to be culated detection limit for that analysis is comparable with contamination/background inserted for the concentration. levels of blank filters. The decision is based, 2. If the abatement site does not satisfy ei- in part, on Poisson statistics which indicate ther (1) or (2) of this Section C, the site must that four structures must be counted on a be recleaned and a new set of samples col- filter before the fiber count is statistically lected. distinguishable from the count for one structure. As more information on the perform- D. Sequence for Analyzing Samples ance of the method is collected, this cri- It is possible to determine completion of terion may be modified. Since different com- the response action without analyzing all binations of the number and size of grid samples. Also, at any point in the process, a openings are permitted under the TEM pro- decision may be made to terminate the anal- tocol, the criterion is expressed in structures ysis of existing samples, reclean the abate- per square millimeter of filter to be con- ment site, and collect a new set of samples. sistent across all combinations. Four struc- The following sequence is outlined to mini- tures per 10 grid openings corresponds to ap- mize the number of analyses needed to reach 2 proximately 70 s/mm . a decision. B. Sample Collection and Analysis 1. Analyze the inside samples. 2. If at least 1,199 L of air for a 25 mm filter 1. A minimum of 13 samples is required: or 2,799 L of air for a 37 mm filter is collected five samples collected inside the abatement for each inside sample and the arithmetic area, five samples collected outside the mean concentration of structures per square abatement area, two field blanks, and one millimeter of filter is less than or equal to 70 sealed blank. s/mm2, the response action is complete and 2. Sampling and TEM analysis must be no further analysis is needed. done according to either the mandatory or 3. If less than 1,199 L of air for a 25 mm fil- nonmandatory protocols in Appendix A. At ter or 2,799 L of air for a 37 mm filter is col- least 0.057 mm2 of filter must be examined on lected for any of the inside samples, or the blank filters. arithmetic mean concentration of structures per square millimeter of filter is greater than C. Interpretation of Results 70 s/mm2, analyze the three blanks. 1. The response action shall be considered 4. If the arithmetic mean concentration of complete if either: structures per square millimeter on the a. Each sample collected inside the abate- blank filters is greater than 70 s/mm2, termi- ment area consists of at least 1,199 L of air nate the analysis, identify and correct the for a 25 mm filter, or 2,799 L of air for a 37 source of blank contamination, and collect a mm filter, and the arithmetic mean of their new set of samples. asbestos structure concentrations per square 5. If the arithmetic mean concentration of millimeter of filter is less than or equal to 70 structures per square millimeter on the s/mm2; or blank filters is less than or equal to 70 s/ b. The three blank samples have an arith- mm2, analyze the outside samples and per- metic mean of the asbestos structure conform the Z-test.

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6. If the Z-statistic is less than or equal to compliance with applicable statutes or regu- 1.65, the response action is complete. If the lations; or Z-statistic is greater than 1.65, reclean the c. visual inspections of the type described abatement site and collect a new set of sam- in 40 CFR 763.90(i) solely for the purpose of ples. determining completion of response actions. [52 FR 41857, Oct. 30, 1987] 4. ‘‘Major fiber release episode’’ means any uncontrolled or unintentional disturbance of APPENDIX B TO SUBPART E OF PART 763 ACBM, resulting in a visible emission, which involves the falling or dislodging of more [RESERVED] than 3 square or linear feet of friable ACBM. 5. ‘‘Minor fiber release episode’’ means any APPENDIX C TO SUBPART E OF PART uncontrolled or unintentional disturbance of 763—ASBESTOS MODEL ACCREDITA- ACBM, resulting in a visible emission, which TION PLAN involves the falling or dislodging of 3 square I. Asbestos Model Accreditation Plan for States or linear feet or less of friable ACBM. 6. ‘‘Public and commercial building’’ The Asbestos Model Accreditation Plan means the interior space of any building (MAP) for States has eight components: which is not a school building, except that (A) Definitions the term does not include any residential (B) Initial Training apartment building of fewer than 10 units or (C) Examinations detached single-family homes. The term in- (D) Continuing Education cludes, but is not limited to: industrial and (E) Qualifications office buildings, residential apartment build- (F) Recordkeeping Requirements for Train- ings and condominiums of 10 or more dwelling Providers ing units, government-owned buildings, col- (G) Deaccreditation leges, museums, airports, hospitals, church- (H) Reciprocity es, preschools, stores, warehouses and fac- (I) Electronic reporting tories. Interior space includes exterior hall- A. Definitions ways connecting buildings, porticos, and me- For purposes of Appendix C: chanical systems used to condition interior 1. ‘‘Friable asbestos-containing material space. (ACM)’’ means any material containing more than one percent asbestos which has been ap- 7. ‘‘Response action’’ means a method, in- plied on ceilings, walls, structural members, cluding removal, encapsulation, enclosure, piping, duct work, or any other part of a repair, and operation and maintenance, that building, which when dry, may be crumbled, protects human health and the environment pulverized, or reduced to powder by hand from friable ACBM. pressure. The term includes non-friable as- 8. ‘‘Small-scale, short-duration activities bestos-containing material after such pre- (SSSD)’’ are tasks such as, but not limited viously non-friable material becomes dam- to: aged to the extent that when dry it may be a. Removal of asbestos-containing insula- crumbled, pulverized, or reduced to powder tion on pipes. by hand pressure. b. Removal of small quantities of asbestos- 2. ‘‘Friable asbestos-containing building containing insulation on beams or above material (ACBM)’’ means any friable ACM ceilings. that is in or on interior structural members c. Replacement of an asbestos-containing or other parts of a school or public and com- gasket on a valve. mercial building. d. Installation or removal of a small sec- 3. ‘‘Inspection’’ means an activity under- tion of drywall. taken in a school building, or a public and e. Installation of electrical conduits commercial building, to determine the pres- through or proximate to asbestos-containing ence or location, or to assess the condition materials. of, friable or non-friable asbestos-containing SSSD can be further defined by the fol- building material (ACBM) or suspected lowing considerations: ACBM, whether by visual or physical exam- f. Removal of small quantities of ACM only ination, or by collecting samples of such ma- if required in the performance of another terial. This term includes reinspections of maintenance activity not intended as asbes- friable and non-friable known or assumed tos abatement. ACBM which has been previously identified. g. Removal of asbestos-containing thermal The term does not include the following: system insulation not to exceed amounts a. Periodic surveillance of the type de- greater than those which can be contained in scribed in 40 CFR 763.92(b) solely for the pur- a single glove bag. pose of recording or reporting a change in h. Minor repairs to damaged thermal sys- the condition of known or assumed ACBM; tem insulation which do not require re- b. Inspections performed by employees or moval. agents of Federal, State, or local govern- i. Repairs to a piece of asbestos-containing ment solely for the purpose of determining wallboard.

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j. Repairs, involving encapsulation, enclo- seeking accreditation in any of the five ac- sure, or removal, to small amounts of friable credited MAP disciplines cannot attend two ACM only if required in the performance of or more courses concurrently, but may at- emergency or routine maintenance activity tend such courses sequentially. and not intended solely as asbestos abate- In several instances, initial training ment. Such work may not exceed amounts courses for a specific discipline (e.g., work- greater than those which can be contained in ers, inspectors) require hands-on training. a single prefabricated mini-enclosure. Such For asbestos abatement contractor/super- an enclosure shall conform spatially and geo- visors and workers, hands-on training should metrically to the localized work area, in include working with asbestos-substitute order to perform its intended containment materials, fitting and using respirators, use function. of glovebags, donning protective clothing, B. Initial Training and constructing a decontamination unit as well as other abatement work activities. Training requirements for purposes of accreditation are specified both in terms of re- 1. WORKERS quired subjects of instruction and in terms of length of training. Each initial training A person must be accredited as a worker to course has a prescribed curriculum and num- carry out any of the following activities with ber of days of training. One day of training respect to friable ACBM in a school or public equals 8 hours, including breaks and lunch. and commercial building: (1) A response ac- Course instruction must be provided by EPA tion other than a SSSD activity, (2) a main- or State-approved instructors. EPA or State tenance activity that disturbs friable ACBM instructor approval shall be based upon a re- other than a SSSD activity, or (3) a response view of the instructor’s academic credentials action for a major fiber release episode. All and/or field experience in asbestos abate- persons seeking accreditation as asbestos ment. abatement workers shall complete at least a Beyond the initial training requirements, 4–day training course as outlined below. The individual States may wish to consider re- 4–day worker training course shall include quiring additional days of training for pur- lectures, demonstrations, at least 14 hours of poses of supplementing hands-on activities hands-on training, individual respirator fit or for reviewing relevant state regulations. testing, course review, and an examination. States also may wish to consider the relative Hands-on training must permit workers to merits of a worker apprenticeship program. have actual experience performing tasks as- Further, they might consider more stringent sociated with asbestos abatement. A person minimum qualification standards for the ap- who is otherwise accredited as a contractor/ proval of training instructors. EPA rec- supervisor may perform in the role of a ommends that the enrollment in any given worker without possessing separate accredi- course be limited to 25 students so that ade- tation as a worker. quate opportunities exist for individual Because of cultural diversity associated hands-on experience. with the asbestos workforce, EPA rec- States have the option to provide initial ommends that States adopt specific stand- training directly or approve other entities to ards for the approval of foreign language offer training. The following requirements courses for abatement workers. EPA further are for the initial training of persons re- recommends the use of audio-visual mate- quired to have accreditation under TSCA rials to complement lectures, where appro- Title II. priate. Training requirements for each of the five The training course shall adequately ad- accredited disciplines are outlined below. dress the following topics: Persons in each discipline perform a different job function and distinct role. Inspec- (a) Physical characteristics of asbestos. Iden- tors identify and assess the condition of tification of asbestos, aerodynamic charac- ACBM, or suspect ACBM. Management plan- teristics, typical uses, and physical appear- ners use data gathered by inspectors to as- ance, and a summary of abatement control sess the degree of hazard posed by ACBM in options. schools to determine the scope and timing of (b) Potential health effects related to asbestos appropriate response actions needed for exposure. The nature of asbestos-related dis- schools. Project designers determine how as- eases; routes of exposure; dose-response rela- bestos abatement work should be conducted. tionships and the lack of a safe exposure Lastly, workers and contractor/supervisors level; the synergistic effect between ciga- carry out and oversee abatement work. In rette smoking and asbestos exposure; the la- addition, a recommended training cur- tency periods for asbestos-related diseases; a riculum is also presented for a sixth dis- discussion of the relationship of asbestos ex- cipline, which is not federally-accredited, posure to asbestosis, lung cancer, mesothe- that of ‘‘Project Monitor.’’ Each accredited lioma, and cancers of other organs. discipline and training curriculum is sepa- (c) Employee personal protective equipment. rate and distinct from the others. A person Classes and characteristics of respirator

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types; limitations of respirators; proper se- 2. CONTRACTOR/SUPERVISORS lection, inspection; donning, use, mainte- A person must be accredited as a con- nance, and storage procedures for res- tractor/supervisor to supervise any of the pirators; methods for field testing of the following activities with respect to friable facepiece-to-face seal (positive and negative- ACBM in a school or public and commercial pressure fit checks); qualitative and quan- building: (1) A response action other than a titative fit testing procedures; variability SSSD activity, (2) a maintenance activity between field and laboratory protection fac- that disturbs friable ACBM other than a tors that alter respiratory fit (e.g., facial SSSD activity, or (3) a response action for a hair); the components of a proper respiratory major fiber release episode. All persons seek- protection program; selection and use of per- ing accreditation as asbestos abatement con- sonal protective clothing; use, storage, and tractor/supervisors shall complete at least a handling of non-disposable clothing; and reg- 5–day training course as outlined below. The ulations covering personal protective equip- training course must include lectures, dem- ment. onstrations, at least 14 hours of hands-on (d) State-of-the-art work practices. Proper training, individual respirator fit testing, work practices for asbestos abatement ac- course review, and a written examination. tivities, including descriptions of proper con- Hands-on training must permit supervisors struction; maintenance of barriers and de- to have actual experience performing tasks contamination enclosure systems; posi- associated with asbestos abatement. tioning of warning signs; lock-out of elec- EPA recommends the use of audiovisual trical and ventilation systems; proper work- materials to complement lectures, where ap- ing techniques for minimizing fiber release; propriate. use of wet methods; use of negative pressure Asbestos abatement supervisors include those persons who provide supervision and exhaust ventilation equipment; use of high- direction to workers performing response ac- efficiency particulate air (HEPA) vacuums; tions. Supervisors may include those individ- proper clean-up and disposal procedures; uals with the position title of foreman, work practices for removal, encapsulation, working foreman, or leadman pursuant to enclosure, and repair of ACM; emergency collective bargaining agreements. At least procedures for sudden releases; potential ex- one supervisor is required to be at the work- posure situations; transport and disposal site at all times while response actions are procedures; and recommended and prohibited being conducted. Asbestos workers must work practices. have access to accredited supervisors (e) Personal hygiene. Entry and exit proce- throughout the duration of the project. dures for the work area; use of showers; The contractor/supervisor training course avoidance of eating, drinking, smoking, and shall adequately address the following top- chewing (gum or tobacco) in the work area; ics: and potential exposures, such as family expo- (a) The physical characteristics of asbestos sure. and asbestos-containing materials. Identifica- (f) Additional safety hazards. Hazards en- tion of asbestos, aerodynamic characteris- countered during abatement activities and tics, typical uses, physical appearance, a re- how to deal with them, including electrical view of hazard assessment considerations, hazards, heat stress, air contaminants other and a summary of abatement control op- than asbestos, fire and explosion hazards, tions. scaffold and ladder hazards, slips, trips, and (b) Potential health effects related to asbestos falls, and confined spaces. exposure. The nature of asbestos-related dis- (g) Medical monitoring. OSHA and EPA eases; routes of exposure; dose-response rela- Worker Protection Rule requirements for tionships and the lack of a safe exposure physical examinations, including a pul- level; synergism between cigarette smoking monary function test, chest X-rays, and a and asbestos exposure; and latency period for medical history for each employee. diseases. (c) Employee personal protective equipment. (h) Air monitoring. Procedures to determine Classes and characteristics of respirator airborne concentrations of asbestos fibers, types; limitations of respirators; proper se- focusing on how personal air sampling is per- lection, inspection, donning, use, mainte- formed and the reasons for it. nance, and storage procedures for res- (i) Relevant Federal, State, and local regu- pirators; methods for field testing of the latory requirements, procedures, and standards. facepiece-to-face seal (positive and negative- With particular attention directed at rel- pressure fit checks); qualitative and quan- evant EPA, OSHA, and State regulations titative fit testing procedures; variability concerning asbestos abatement workers. between field and laboratory protection fac- (j) Establishment of respiratory protection tors that alter respiratory fit (e.g., facial programs. hair); the components of a proper respiratory (k) Course review. A review of key aspects protection program; selection and use of per- of the training course. sonal protective clothing; and use, storage,

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and handling of non-disposable clothing; and (iv) OSHA Asbestos Construction Standard regulations covering personal protective (29 CFR 1926.58). (v)EPA Worker Protection equipment. Rule, (40 CFR part 763, Subpart G). (d) State-of-the-art work practices. Proper (j) Respiratory Protection Programs and Med- work practices for asbestos abatement ac- ical Monitoring Programs. tivities, including descriptions of proper con- (k) Insurance and liability issues. Contractor struction and maintenance of barriers and issues; worker’s compensation coverage and decontamination enclosure systems; posi- exclusions; third-party liabilities and de- tioning of warning signs; lock-out of elec- fenses; insurance coverage and exclusions. trical and ventilation systems; proper work- (l) Recordkeeping for asbestos abatement ing techniques for minimizing fiber release; projects. Records required by Federal, State, use of wet methods; use of negative pressure and local regulations; records recommended exhaust ventilation equipment; use of HEPA for legal and insurance purposes. vacuums; and proper clean-up and disposal (m) Supervisory techniques for asbestos abate- procedures. Work practices for removal, en- ment activities. Supervisory practices to encapsulation, enclosure, and repair of ACM; force and reinforce the required work prac- emergency procedures for unplanned re- tices and discourage unsafe work practices. leases; potential exposure situations; trans- (n) Contract specifications. Discussions of port and disposal procedures; and rec- key elements that are included in contract ommended and prohibited work practices. specifications. New abatement-related techniques and (o) Course review. A review of key aspects methodologies may be discussed. of the training course. (e) Personal hygiene. Entry and exit procedures for the work area; use of showers; and 3. INSPECTOR avoidance of eating, drinking, smoking, and chewing (gum or tobacco) in the work area. All persons who inspect for ACBM in Potential exposures, such as family expo- schools or public and commercial buildings sure, shall also be included. must be accredited. All persons seeking ac- (f) Additional safety hazards. Hazards en- creditation as an inspector shall complete at countered during abatement activities and least a 3–day training course as outlined how to deal with them, including electrical below. The course shall include lectures, hazards, heat stress, air contaminants other demonstrations, 4 hours of hands-on train- than asbestos, fire and explosion hazards, ing, individual respirator fit-testing, course scaffold and ladder hazards, slips, trips, and review, and a written examination. falls, and confined spaces. EPA recommends the use of audiovisual (g) Medical monitoring. OSHA and EPA materials to complement lectures, where ap- Worker Protection Rule requirements for propriate. Hands-on training should include physical examinations, including a pul- conducting a simulated building walk- monary function test, chest X-rays and a through inspection and respirator fit testing. medical history for each employee. The inspector training course shall ade- (h) Air monitoring. Procedures to determine quately address the following topics: airborne concentrations of asbestos fibers, (a) Background information on asbestos. including descriptions of aggressive air sam- Identification of asbestos, and examples and pling, sampling equipment and methods, rea- discussion of the uses and locations of asbes- sons for air monitoring, types of samples and tos in buildings; physical appearance of as- interpretation of results. bestos. EPA recommends that transmission elec- (b) Potential health effects related to asbestos tron microscopy (TEM) be used for analysis exposure. The nature of asbestos-related dis- of final air clearance samples, and that sam- eases; routes of exposure; dose-response rela- ple analyses be performed by laboratories ac- tionships and the lack of a safe exposure credited by the National Institute of Stand- level; the synergistic effect between ciga- ards and Technology’s (NIST) National Vol- rette smoking and asbestos exposure; the la- untary Laboratory Accreditation Program tency periods for asbestos-related diseases; a (NVLAP). discussion of the relationship of asbestos ex- (i) Relevant Federal, State, and local regu- posure to asbestosis, lung cancer, mesothe- latory requirements, procedures, and standards, lioma, and cancers of other organs. including: (c) Functions/qualifications and role of in- (i) Requirements of TSCA Title II. spectors. Discussions of prior experience and (ii) National Emission Standards for Haz- qualifications for inspectors and manage- ardous Air Pollutants (40 CFR part 61), Sub- ment planners; discussions of the functions parts A (General Provisions) and M (National of an accredited inspector as compared to Emission Standard for Asbestos). those of an accredited management planner; (iii) OSHA standards for permissible expo- discussion of inspection process including insure to airborne concentrations of asbestos ventory of ACM and physical assessment. fibers and respiratory protection (29 CFR (d) Legal liabilities and defenses. Respon- 1910.134). sibilities of the inspector and management

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planner; a discussion of comprehensive gen- surance procedures. EPA’s recommendation eral liability policies, claims-made, and oc- that all bulk samples collected from school currence policies, environmental and pollu- or public and commercial buildings be ana- tion liability policy clauses; state liability lyzed by a laboratory accredited under the insurance requirements; bonding and the re- NVLAP administered by NIST. lationship of insurance availability to bond (j) Inspector respiratory protection and per- availability. sonal protective equipment. Classes and char- (e) Understanding building systems. The acteristics of respirator types; limitations of interrelationship between building systems, respirators; proper selection, inspection; including: an overview of common building donning, use, maintenance, and storage pro- physical plan layout; heat, ventilation, and cedures for respirators; methods for field air conditioning (HVAC) system types, phys- testing of the facepiece-to-face seal (positive ical organization, and where asbestos is and negative-pressure fit checks); quali- found on HVAC components; building me- tative and quantitative fit testing proce- chanical systems, their types and organiza- dures; variability between field and labora- tion, and where to look for asbestos on such tory protection factors that alter respiratory systems; inspecting electrical systems, in- fit (e.g., facial hair); the components of a cluding appropriate safety precautions; read- proper respiratory protection program; se- ing blueprints and as-built drawings. lection and use of personal protective cloth- (f) Public/employee/building occupant rela- ing; use, storage, and handling of non-dispos- tions. Notifying employee organizations able clothing. about the inspection; signs to warn building (k) Recordkeeping and writing the inspection occupants; tact in dealing with occupants report. Labeling of samples and keying sam- and the press; scheduling of inspections to ple identification to sampling location; rec- minimize disruptions; and education of ommendations on sample labeling; detailing building occupants about actions being of ACM inventory; photographs of selected taken. sampling areas and examples of ACM condi- (g) Pre-inspection planning and review of pre- tion; information required for inclusion in vious inspection records. Scheduling the in- the management plan required for school spection and obtaining access; building buildings under TSCA Title II, section 203 record review; identification of probable ho- (i)(1). EPA recommends that States develop mogeneous areas from blueprints or as-built and require the use of standardized forms for drawings; consultation with maintenance or recording the results of inspections in building personnel; review of previous in- schools or public or commercial buildings, spection, sampling, and abatement records of and that the use of these forms be incor- a building; the role of the inspector in exclu- porated into the curriculum of training con- sions for previously performed inspections. ducted for accreditation. (h) Inspecting for friable and non-friable (l) Regulatory review. The following topics ACM and assessing the condition of friable should be covered: National Emission Stand- ACM. Procedures to follow in conducting vis- ards for Hazardous Air Pollutants (NESHAP; ual inspections for friable and non-friable 40 CFR part 61, Subparts A and M); EPA ACM; types of building materials that may Worker Protection Rule (40 CFR part 763, contain asbestos; touching materials to de- Subpart G); OSHA Asbestos Construction termine friability; open return air plenums Standard (29 CFR 1926.58); OSHA respirator and their importance in HVAC systems; as- requirements (29 CFR 1910.134); the Asbestos- sessing damage, significant damage, poten- Containing Materials in School Rule (40 CFR tial damage, and potential significant dam- part 763, Subpart E; applicable State and age; amount of suspected ACM, both in total local regulations, and differences between quantity and as a percentage of the total Federal and State requirements where they area; type of damage; accessibility; mate- apply, and the effects, if any, on public and rial’s potential for disturbance; known or nonpublic schools or commercial or public suspected causes of damage or significant buildings. damage; and deterioration as assessment fac- (m) Field trip. This includes a field exer- tors. cise, including a walk-through inspection; (i) Bulk sampling/documentation of asbestos. on-site discussion about information gath- Detailed discussion of the ‘‘Simplified Sam- ering and the determination of sampling lo- pling Scheme for Friable Surfacing Mate- cations; on-site practice in physical assess- rials (EPA 560/5-85-030a October 1985)’’; tech- ment; classroom discussion of field exercise. niques to ensure sampling in a randomly dis- (n) Course review. A review of key aspects tributed manner for other than friable sur- of the training course. facing materials; sampling of non-friable ma- 4. MANAGEMENT PLANNER terials; techniques for bulk sampling; inspector’s sampling and repair equipment; All persons who prepare management plans patching or repair of damage from sampling; for schools must be accredited. All persons discussion of polarized light microscopy; seeking accreditation as management plan- choosing an accredited laboratory to analyze ners shall complete a 3–day inspector train- bulk samples; quality control and quality as- ing course as outlined above and a 2–day

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management planner training course. Pos- proach to design of high-quality job speci- session of current and valid inspector accred- fications. itation shall be a prerequisite for admission (g) Developing an operations and mainte- to the management planner training course. nance (O&M) plan. Purpose of the plan; dis- The management planner course shall in- cussion of applicable EPA guidance docu- clude lectures, demonstrations, course re- ments; what actions should be taken by cus- view, and a written examination. todial staff; proper cleaning procedures; EPA recommends the use of audiovisual steam cleaning and HEPA vacuuming; reduc- materials to complement lectures, where ap- ing disturbance of ACM; scheduling O&M for propriate. off-hours; rescheduling or canceling renova- TSCA Title II does not require accreditation in areas with ACM; boiler room mainte- tion for persons performing the management nance; disposal of ACM; in-house procedures planner role in public and commercial build- for ACM—bridging and penetrating ings. Nevertheless, such persons may find encapsulants; pipe fittings; metal sleeves; this training and accreditation helpful in polyvinyl chloride (PVC), canvas, and wet preparing them to design or administer as- wraps; muslin with straps, fiber mesh cloth; bestos operations and maintenance programs mineral wool, and insulating cement; discus- for public and commercial buildings. sion of employee protection programs and The management planner training course staff training; case study in developing an shall adequately address the following top- O&M plan (development, implementation ics: process, and problems that have been experi- (a) Course overview. The role and respon- enced). sibilities of the management planner; oper- (h) Regulatory review. Focusing on the ations and maintenance programs; setting OSHA Asbestos Construction Standard found work priorities; protection of building occu- at 29 CFR 1926.58; the National Emission pants. Standard for Hazardous Air Pollutants (b) Evaluation/interpretation of survey re- (NESHAP) found at 40 CFR part 61, Subparts sults. Review of TSCA Title II requirements A (General Provisions) and M (National for inspection and management plans for Emission Standard for Asbestos); EPA Work- school buildings as given in section 203(i)(1) er Protection Rule found at 40 CFR part 763, of TSCA Title II; interpretation of field data Subpart G; TSCA Title II; applicable State and laboratory results; comparison of field regulations. inspector’s data sheet with laboratory re- (i) Recordkeeping for the management plan- sults and site survey. ner. Use of field inspector’s data sheet along (c) Hazard assessment. Amplification of the with laboratory results; on-going record- difference between physical assessment and keeping as a means to track asbestos dis- hazard assessment; the role of the manage- turbance; procedures for recordkeeping. EPA ment planner in hazard assessment; expla- recommends that States require the use of nation of significant damage, damage, poten- standardized forms for purposes of manage- tial damage, and potential significant dam- ment plans and incorporate the use of such age; use of a description (or decision tree) forms into the initial training course for code for assessment of ACM; assessment of management planners. friable ACM; relationship of accessibility, vi- (j) Assembling and submitting the manage- bration sources, use of adjoining space, and ment plan. Plan requirements for schools in air plenums and other factors to hazard as- TSCA Title II section 203(i)(1); the manage- sessment. ment plan as a planning tool. (d) Legal implications. Liability; insurance (k) Financing abatement actions. Economic issues specific to planners; liabilities associ- analysis and cost estimates; development of ated with interim control measures, in-house cost estimates; present costs of abatement maintenance, repair, and removal; use of re- versus future operation and maintenance sults from previously performed inspections. costs; Asbestos School Hazard Abatement (e) Evaluation and selection of control op- Act grants and loans. tions. Overview of encapsulation, enclosure, (l) Course review. A review of key aspects of interim operations and maintenance, and re- the training course. moval; advantages and disadvantages of each method; response actions described via a de- 5. PROJECT DESIGNER cision tree or other appropriate method; A person must be accredited as a project work practices for each response action; designer to design any of the following ac- staging and prioritizing of work in both va- tivities with respect to friable ACBM in a cant and occupied buildings; the need for school or public and commercial building: (1) containment barriers and decontamination A response action other than a SSSD main- in response actions. tenance activity, (2) a maintenance activity (f) Role of other professionals. Use of indus- that disturbs friable ACBM other than a trial hygienists, engineers, and architects in SSSD maintenance activity, or (3) a response developing technical specifications for reaction for a major fiber release episode. All sponse actions; any requirements that may persons seeking accreditation as a project exist for architect sign-off of plans; team ap- designer shall complete at least a minimum

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3–day training course as outlined below. The how to deal with them, including electrical project designer course shall include lec- hazards, heat stress, air contaminants other tures, demonstrations, a field trip, course re- than asbestos, fire, and explosion hazards. view and a written examination. (h) Fiber aerodynamics and control. Aero- EPA recommends the use of audiovisual dynamic characteristics of asbestos fibers; materials to complement lectures, where ap- importance of proper containment barriers; propriate. settling time for asbestos fibers; wet meth- The abatement project designer training ods in abatement; aggressive air monitoring course shall adequately address the following following abatement; aggressive air move- topics: ment and negative-pressure exhaust ventila- (a) Background information on asbestos. tion as a clean-up method. Identification of asbestos; examples and dis- (i) Designing abatement solutions. Discus- cussion of the uses and locations of asbestos sions of removal, enclosure, and encapsula- in buildings; physical appearance of asbestos. tion methods; asbestos waste disposal. (b) Potential health effects related to asbestos exposure. Nature of asbestos-related diseases; (j) Final clearance process. Discussion of the routes of exposure; dose-response relation- need for a written sampling rationale for ag- ships and the lack of a safe exposure level; gressive final air clearance; requirements of the synergistic effect between cigarette a complete visual inspection; and the rela- smoking and asbestos exposure; the latency tionship of the visual inspection to final air period of asbestos-related diseases; a discus- clearance. sion of the relationship between asbestos ex- EPA recommends the use of TEM for anal- posure and asbestosis, lung cancer, mesothe- ysis of final air clearance samples. These lioma, and cancers of other organs. samples should be analyzed by laboratories (c) Overview of abatement construction accredited under the NIST NVLAP. projects. Abatement as a portion of a renova- (k) Budgeting/cost estimating. Development tion project; OSHA requirements for notifi- of cost estimates; present costs of abatement cation of other contractors on a multi-em- versus future operation and maintenance ployer site (29 CFR 1926.58). costs; setting priorities for abatement jobs (d) Safety system design specifications. De- to reduce costs. sign, construction, and maintenance of con- (l) Writing abatement specifications. Prepara- tainment barriers and decontamination en- tion of and need for a written project design; closure systems; positioning of warning means and methods specifications versus signs; electrical and ventilation system lock- performance specifications; design of abate- out; proper working techniques for mini- ment in occupied buildings; modification of mizing fiber release; entry and exit proce- guide specifications for a particular building; dures for the work area; use of wet methods; worker and building occupant health/medical proper techniques for initial cleaning; use of considerations; replacement of ACM with negative-pressure exhaust ventilation equip- non-asbestos substitutes. ment; use of HEPA vacuums; proper clean-up (m) Preparing abatement drawings. Signifi- and disposal of asbestos; work practices as cance and need for drawings, use of as-built they apply to encapsulation, enclosure, and drawings as base drawings; use of inspection repair; use of glove bags and a demonstration photographs and on-site reports; methods of of glove bag use. preparing abatement drawings; diagramming (e) Field trip. A visit to an abatement site containment barriers; relationship of draw- or other suitable building site, including on- ings to design specifications; particular site discussions of abatement design and problems related to abatement drawings. building walk-through inspection. Include (n) Contract preparation and administration. discussion of rationale for the concept of functional spaces during the walk-through. (o) Legal/liabilities/defenses. Insurance con- (f) Employee personal protective equipment. siderations; bonding; hold-harmless clauses; Classes and characteristics of respirator use of abatement contractor’s liability insur- types; limitations of respirators; proper se- ance; claims made versus occurrence poli- lection, inspection; donning, use, mainte- cies. nance, and storage procedures for res- (p) Replacement. Replacement of asbestos pirators; methods for field testing of the with asbestos-free substitutes. facepiece-to-face seal (positive and negative- (q) Role of other consultants. Development pressure fit checks); qualitative and quan- of technical specification sections by indus- titative fit testing procedures; variability trial hygienists or engineers; the multi-dis- between field and laboratory protection fac- ciplinary team approach to abatement de- tors that alter respiratory fit (e.g., facial sign. hair); the components of a proper respiratory (r) Occupied buildings. Special design proce- protection program; selection and use of per- dures required in occupied buildings; edu- sonal protective clothing; use, storage, and cation of occupants; extra monitoring rec- handling of non-disposable clothing. ommendations; staging of work to minimize (g) Additional safety hazards. Hazards en- occupant exposure; scheduling of renovation countered during abatement activities and to minimize exposure.

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(s) Relevant Federal, State, and local regu- EPA Worker Protection Rule, 40 CFR part latory requirements, procedures and standards, 763, subpart G. Overview of pertinent OSHA including, but not limited to: regulations, including: Construction Indus- (i) Requirements of TSCA Title II. try Standard for Asbestos, 29 CFR 1926.58; (ii) National Emission Standards for Haz- Respirator Standard, 29 CFR 1910.134; and the ardous Air Pollutants, (40 CFR part 61) sub- Hazard Communication Standard, 29 CFR parts A (General Provisions) and M (National 1926.59. Applicable State and local asbestos Emission Standard for Asbestos). regulations; regulatory interrelationships. (iii) OSHA Respirator Standard found at 29 (d) Understanding building construction and CFR 1910.134. building systems. Building construction ba- (iv) EPA Worker Protection Rule found at sics, building physical plan layout; under- 40 CFR part 763, subpart G. standing building systems (HVAC, electrical, (v) OSHA Asbestos Construction Standard etc.); layout and organization, where asbes- found at 29 CFR 1926.58. tos is likely to be found on building systems; (vi) OSHA Hazard Communication Stand- renovations and the effect of asbestos abate- ard found at 29 CFR 1926.59. ment on building systems. (t) Course review. A review of key aspects of (e) Asbestos abatement contracts, specifica- the training course. tions, and drawings. Basic provisions of the contract; relationships between principle 6. PROJECT MONITOR parties, establishing chain of command; EPA recommends that States adopt train- types of specifications, including means and ing and accreditation requirements for per- methods, performance, and proprietary and sons seeking to perform work as project nonproprietary; reading and interpreting monitors. Project monitors observe abate- records and abatement drawings; discussion ment activities performed by contractors of change orders; common enforcement re- and generally serve as a building owner’s sponsibilities and authority of project mon- representative to ensure that abatement itor. work is completed according to specification (f) Response actions and abatement practices. and in compliance with all relevant statutes Pre-work inspections; pre-work consider- and regulations. They may also perform the ations, precleaning of the work area, re- vital role of air monitoring for purposes of moval of furniture, fixtures, and equipment; determining final clearance. EPA rec- shutdown/modification of building systems; ommends that a State seeking to accredit in- construction and maintenance of contain- dividuals as project monitors consider adopt- ment barriers, proper demarcation of work ing a minimum 5–day training course cov- areas; work area entry/exit, hygiene prac- ering the topics outlined below. The course tices; determining the effectiveness of air fil- outlined below consists of lectures and dem- tration equipment; techniques for mini- onstrations, at least 6 hours of hands-on mizing fiber release, wet methods, contin- training, course review, and a written exam- uous cleaning; abatement methods other ination. The hands-on training component than removal; abatement area clean-up pro- might be satisfied by having the student cedures; waste transport and disposal proce- simulate participation in or performance of dures; contingency planning for emergency any of the relevant job functions or activi- response. ties (or by incorporation of the workshop (g) Asbestos abatement equipment. Typical component described in item ‘‘n’’ below of equipment found on an abatement project; this unit). air filtration devices, vacuum systems, nega- EPA recommends that the project monitor tive pressure differential monitoring; HEPA training course adequately address the fol- filtration units, theory of filtration, design/ lowing topics: construction of HEPA filtration units, quali- (a) Roles and responsibilities of the project tative and quantitative performance of monitor. Definition and responsibilities of the HEPA filtration units, sizing the ventilation project monitor, including regulatory/speci- requirements, location of HEPA filtration fication compliance monitoring, air moni- units, qualitative and quantitative tests of toring, conducting visual inspections, and containment barrier integrity; best available final clearance monitoring. technology. (b) Characteristics of asbestos and asbestos- (h) Personal protective equipment. Proper se- containing materials. Typical uses of asbestos; lection of respiratory protection; classes and physical appearance of asbestos; review of characteristics of respirator types, limita- asbestos abatement and control techniques; tions of respirators; proper use of other safe- presentation of the health effects of asbestos ty equipment, protective clothing selection, exposure, including routes of exposure, dose- use, and proper handling, hard/bump hats, response relationships, and latency periods safety shoes; breathing air systems, high for asbestos-related diseases. pressure v. low pressure, testing for Grade D (c) Federal asbestos regulations. Overview of air, determining proper backup air volumes. pertinent EPA regulations, including: (i) Air monitoring strategies. Sampling NESHAP, 40 CFR part 61, subparts A and M; equipment, sampling pumps (low v. high vol- AHERA, 40 CFR part 763, subpart E; and the ume), flow regulating devices (critical and

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limiting orifices), use of fibrous aerosol mon- the building owner based on given conditions itors on abatement projects; sampling and these documents. media, types of filters, types of cassettes, fil- Air monitoring strategies/asbestos abate- ter orientation, storage and shipment of fil- ment equipment: This workshop could con- ters; calibration techniques, primary cali- sist of simulated abatement sites for which bration standards, secondary calibration sampling strategies would have to be devel- standards, temperature/pressure effects, fre- oped (i.e., occupied buildings, industrial situ- quency of calibration, recordkeeping and ations). Through demonstrations and exhi- field work documentation, calculations; air bition, the project monitor may also be able sample analysis, techniques available and to gain a better understanding of the func- limitations of AHERA on their use, trans- tion of various pieces of equipment used on mission electron microscopy (background to sample preparation and analysis, air sample abatement projects (air filtration units, conditions which prohibit analysis, EPA’s water filtration units, negative pressure recommended technique for analysis of final monitoring devices, sampling pump calibra- air clearance samples), phase contrast mi- tion devices, etc.). croscopy (background to sample preparation, Conducting visual inspections: This work- and AHERA’s limits on the use of phase con- shop could consist, ideally, of an interactive trast microscopy), what each technique video in which a participant is ‘‘taken measures; analytical methodologies, AHERA through’’ a work area and asked to make TEM protocol, NIOSH 7400, OSHA reference notes of what is seen. A series of questions method (non clearance), EPA recommenda- will be asked which are designed to stimu- tion for clearance (TEM); sampling strate- late a person’s recall of the area. This work- gies for clearance monitoring, types of air shop could consist of a series of two or three samples (personal breathing zone v. fixed- videos with different site conditions and dif- station area) sampling location and objec- ferent degrees of cleanliness. tives (pre-abatement, during abatement, and clearance monitoring), number of samples to C. Examinations be collected, minimum and maximum air volumes, clearance monitoring (post-visual- 1. Each State shall administer a closed inspection) (number of samples required, se- book examination or designate other entities lection of sampling locations, period of sam- such as State-approved providers of training pling, aggressive sampling, interpretations courses to administer the closed-book exam- of sampling results, calculations), quality ination to persons seeking accreditation who assurance; special sampling problems, crawl have completed an initial training course. spaces, acceptable samples for laboratory Demonstration testing may also be included analysis, sampling in occupied buildings as part of the examination. A person seeking (barrier monitoring). initial accreditation in a specific discipline (j) Safety and health issues other than asbes- must pass the examination for that dis- tos. Confined-space entry, electrical hazards, cipline in order to receive accreditation. For fire and explosion concerns, ladders and scaf- example, a person seeking accreditation as folding, heat stress, air contaminants other an abatement project designer must pass the than asbestos, fall hazards, hazardous mate- State’s examination for abatement project rials on abatement projects. designer. (k) Conducting visual inspections. Inspec- States may develop their own examinations during abatement, visual inspections tions, have providers of training courses de- using the ASTM E1368 document; conducting velop examinations, or use standardized ex- inspections for completeness of removal; dis- aminations developed for purposes of accred- cussion of ‘‘how clean is clean?’’ itation under TSCA Title II. In addition, (l) Legal responsibilities and liabilities of States may supplement standardized exami- project monitors. Specification enforcement capabilities; regulatory enforcement; licens- nations with questions about State regula- ing; powers delegated to project monitors tions. States may obtain commercially de- through contract documents. veloped standardized examinations, develop (m) Recordkeeping and report writing. Devel- standardized examinations independently, or oping project logs/daily logs (what should be do so in cooperation with other States, or included, who sees them); final report prepa- with commercial or non-profit providers on a ration; recordkeeping under Federal regula- regional or national basis. EPA recommends tions. the use of standardized, scientifically-vali- (n) Workshops (6 hours spread over 3 days). dated testing instruments, which may be Contracts, specifications, and drawings: This beneficial in terms of both promoting com- workshop could consist of each participant petency and in fostering accreditation reci- being issued a set of contracts, specifica- procity between States. tions, and drawings and then being asked to Each examination shall adequately cover answer questions and make recommenda- the topics included in the training course for tions to a project architect, engineer or to that discipline. Each person who completes a

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training course, passes the required exam- D. Continuing Education ination, and fulfills whatever other requirements the State imposes must receive an ac- For all disciplines, a State’s accreditation creditation certificate in a specific dis- program shall include annual refresher train- cipline. Whether a State directly issues ac- ing as a requirement for reaccreditation as creditation certificates, or authorizes train- indicated below: ing providers to issue accreditation certifi- 1. Workers: One full day of refresher train- cates, each certificate issued to an accred- ing. ited person must contain the following min- 2. Contractor/Supervisors: One full day of imum information: refresher training. a. A unique certificate number 3. Inspectors: One half-day of refresher b. Name of accredited person training. 4. Management Planners: One half-day of c. Discipline of the training course com- inspector refresher training and one half-day pleted. of refresher training for management plan- d. Dates of the training course. ners. e. Date of the examination. 5. Project Designers: One full day of re- f. An expiration date of 1 year after the fresher training. date upon which the person successfully The refresher courses shall be specific to completed the course and examination. each discipline. Refresher courses shall be g. The name, address, and telephone num- conducted as separate and distinct courses ber of the training provider that issued the and not combined with any other training certificate. during the period of the refresher course. For h. A statement that the person receiving each discipline, the refresher course shall re- the certificate has completed the requisite view and discuss changes in Federal, State, training for asbestos accreditation under and local regulations, developments in state- TSCA Title II. of-the-art procedures, and a review of key as- States or training providers who reaccredit pects of the initial training course as deter- persons based upon completion of required mined by the State. After completing the an- refresher training must also provide accredi- nual refresher course, persons shall have tation certificates with all of the above in- their accreditation extended for an addi- formation, except the examination date may tional year from the date of the refresher be omitted if a State does not require a re- course. A State may consider requiring per- fresher examination for reaccreditation. sons to pass reaccreditation examinations at Where a State licenses accredited persons specific intervals (for example, every 3 but has authorized training providers to years). issue accreditation certificates, the State EPA recommends that States formally es- may issue licenses in the form of photo-iden- tablish a 12-month grace period to enable tification cards. Where this applies, EPA rec- formerly accredited persons with expired ommends that the State licenses should in- certificates to complete refresher training clude all of the same information required and have their accreditation status rein- for the accreditation certificates. A State stated without having to re-take the initial may also choose to issue photo-identifica- training course. tion cards in addition to the required accreditation certificates. E. Qualifications Accredited persons must have their initial In addition to requiring training and an ex- and current accreditation certificates at the amination, a State may require candidates location where they are conducting work. for accreditation to meet other qualification 2. The following are the requirements for and/or experience standards that the State examination in each discipline: considers appropriate for some or all dis- a. Worker: ciplines. States may choose to consider re- i. 50 multiple-choice questions quiring qualifications similar to the exam- ii. Passing score: 70 percent correct ples outlined below for inspectors, manage- b. Contractor/Supervisor: ment planners and project designers. States i. 100 multiple-choice questions may modify these examples as appropriate. ii. Passing score: 70 percent correct In addition, States may want to include c. Inspector: some requirements based on experience in i. 50 Multiple-choice questions performing a task directly as a part of a job or in an apprenticeship role. They may also ii. Passing score: 70 percent correct wish to consider additional criteria for the d. Management Planner: approval of training course instructors be- i. 50 Multiple-choice questions yond those prescribed by EPA. ii. Passing score: 70 percent correct 1. Inspectors: Qualifications - possess a e. Project Designer: high school diploma. States may want to re- i. 100 multiple-choice questions quire an Associate’s Degree in specific fields ii. Passing score: 70 percent correct (e.g., environmental or physical sciences).

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2. Management Planners: Qualifications - 5. Verification of certificate information. Registered architect, engineer, or certified EPA recommends that training providers of industrial hygienist or related scientific refresher training courses confirm that their field. students possess valid accreditation before 3. Project Designers: Qualifications - reg- granting course admission. EPA further rec- istered architect, engineer, or certified in- ommends that training providers offering dustrial hygienist. the initial management planner training 4. Asbestos Training Course Instructor: course verify that students have met the pre- Qualifications - academic credentials and/or requisite of possessing valid inspector ac- field experience in asbestos abatement. creditation at the time of course admission. EPA recommends that States prescribe 6. Records retention and access. (a) The minimum qualification standards for train- training provider shall maintain all required ing instructors employed by training pro- records for a minimum of 3 years. The train- viders. ing provider, however, may find it advan- tageous to retain these records for a longer F. Recordkeeping Requirements for Training period of time. Providers (b) The training provider must allow reasonable access to all of the records required All approved providers of accredited asbes- by the MAP, and to any other records which tos training courses must comply with the may be required by States for the approval following minimum recordkeeping require- of asbestos training providers or the accredi- ments. tation of asbestos training courses, to both 1. Training course materials. A training EPA and to State Agencies, on request. EPA provider must retain copies of all instruc- encourages training providers to make this tional materials used in the delivery of the information equally accessible to the general classroom training such as student manuals, public. instructor notebooks and handouts. (c) If a training provider ceases to conduct 2. Instructor qualifications. A training pro- training, the training provider shall notify vider must retain copies of all instructors’ the approving government body (EPA or the resumes, and the documents approving each State) and give it the opportunity to take instructor issued by either EPA or a State. possession of that providers asbestos train- Instructors must be approved by either EPA ing records. or a State before teaching courses for accreditation purposes. A training provider must G. Deaccreditation notify EPA or the State, as appropriate, in 1. States must establish criteria and proce- advance whenever it changes course instruc- dures for deaccrediting persons accredited as tors. Records must accurately identify the workers, contractor/supervisors, inspectors, instructors that taught each particular management planners, and project designers. course for each date that a course is offered. States must follow their own administrative 3. Examinations. A training provider must procedures in pursuing deaccreditation ac- document that each person who receives an tions. At a minimum, the criteria shall in- accreditation certificate for an initial train- clude: ing course has achieved a passing score on (a) Performing work requiring accredita- the examination. These records must clearly tion at a job site without being in physical indicate the date upon which the exam was possession of initial and current accredita- administered, the training course and dis- tion certificates; cipline for which the exam was given, the (b) Permitting the duplication or use of name of the person who proctored the exam, one’s own accreditation certificate by an- a copy of the exam, and the name and test other; score of each person taking the exam. The (c) Performing work for which accredita- topic and dates of the training course must tion has not been received; or correspond to those listed on that person’s (d) Obtaining accreditation from a training accreditation certificate. States may choose provider that does not have approval to offer to apply these same requirements to exami- training for the particular discipline from ei- nations for refresher training courses. ther EPA or from a State that has a con- 4. Accreditation certificates. The training tractor accreditation plan at least as strin- providers or States, whichever issues the ac- gent as the EPA MAP. creditation certificate, shall maintain EPA may directly pursue deaccreditation records that document the names of all per- actions without reliance on State sons who have been awarded certificates, deaccreditation or enforcement authority or their certificate numbers, the disciplines for actions. In addition to the above-listed situa- which accreditation was conferred, training tions, the Administrator may suspend or re- and expiration dates, and the training loca- voke the accreditation of persons who have tion. The training provider or State shall been subject to a final order imposing a civil maintain the records in a manner that al- penalty or convicted under section 16 of lows verification by telephone of the re- TSCA, 15 U.S.C. 2615 or 2647, for violations of quired information. 40 CFR part 763, or section 113 of the Clean

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Air Act, 42 U.S.C. 7413, for violations of 40 possible. Any State that had an accredita- CFR part 61, subpart M. tion program approved by EPA under an ear- 2. Any person who performs asbestos work lier version of the MAP may follow the same requiring accreditation under section 206(a) procedures to obtain EPA approval of their of TSCA, 15 U.S.C. 2646(a), without such ac- accreditation program under this MAP. creditation is in violation of TSCA. The fol- B. Partial approval of a State Program for lowing persons are not accredited for pur- the accreditation of one or more disciplines poses of section 206(a) of TSCA: does not mean that the State is in full com- (a) Any person who obtains accreditation pliance with TSCA where the deadline for through fraudulent representation of train- that State to have adopted a State Plan no ing or examination documents; less stringent than the MAP has already (b) Any person who obtains training docu- passed. State Programs which are at least as mentation through fraudulent means; stringent as the MAP for one or more of the (c) Any person who gains admission to and accredited disciplines may, however, ac- completes refresher training through fraudu- credit persons in those disciplines only. lent representation of initial or previous re- C. States seeking EPA approval or refresher training documentation; or approval of accreditation programs shall (d) Any person who obtains accreditation submit the following information to the Re- through fraudulent representation of accred- gional Asbestos Coordinator at their EPA itation requirements such as education, Regional office: training, professional registration, or experi- 1. A copy of the legislation establishing or ence. upgrading the State’s accreditation program H. Reciprocity (if applicable). 2. A copy of the State’s accreditation regu- EPA recommends that each State establish lations or revised regulations. reciprocal arrangements with other States 3. A letter to the Regional Asbestos Coor- that have established accreditation pro- dinator that clearly indicates how the State grams that meet or exceed the requirements meets the program requirements of this of the MAP. Such arrangements might ad- MAP. Addresses for each of the Regional As- dress cooperation in licensing determina- bestos Coordinators are shown below: tions, the review and approval of training EPA, Region I, (ATC-111) Asbestos Coordi- programs and/or instructors, candidate test- nator, JFK Federal Bldg., Boston, MA ing and exam administration, curriculum de- 02203-2211, (617) 565-3836. velopment, policy formulation, compliance EPA, Region II, (MS-500), Asbestos Coordi- monitoring, and the exchange of information nator, 2890 Woodbridge Ave., Edison, NJ and data. The benefits to be derived from 08837-3679, (908) 321-6671. these arrangements include a potential cost- EPA, Region III, (3AT-33), Asbestos Coordi- savings from the reduction of duplicative ac- nator, 841 Chestnut Bldg., Philadelphia, PA tivity and the attainment of a more profes- 19107, (215) 597-3160. sional accredited workforce as States are EPA, Region IV, Asbestos Coordinator, 345 able to refine and improve the effectiveness Courtland St., N.E., Atlanta, GA 30365, of their programs based upon the experience (404) 347-5014. and methods of other States. EPA, Region V, (SP-14J), Asbestos Coordi- nator, 77 W. Jackson Blvd., Chicago, IL I. Electronic Reporting 60604-3590, (312) 886-6003. States that choose to receive electronic EPA, Region VI, (6T-PT), Asbestos Coordi- documents must include, at a minimum, the nator, 1445 Ross Ave. Dallas, TX 75202-2744, requirements of 40 CFR Part 3—(Electronic (214) 655-7244. reporting) in their programs. EPA, Region VII, (ARTX/ASBS), Asbestos Coordinator, 726 Minnesota Ave., Kansas II. EPA Approval Process for State City, KS 66101, (913) 551-7020. Accreditation Programs EPA, Region VIII, (8AT-TS), Asbestos Coor- A. States may seek approval for a single dinator, 1 Denver Place, Suite 500 999 - 18th discipline or all disciplines as specified in St., Denver, CO 80202-2405, (303) 293-1442. the MAP. For example, a State that cur- EPA, Region IX, Asbestos NESHAPs Con- rently only requires worker accreditation tact, Air Division (A–5), 75 Hawthorne may receive EPA approval for that discipline Street, San Francisco, CA 94105, (415) 972– alone. EPA encourages States that currently 3989. do not have accreditation requirements for EPA, Region X, (AT-083), Asbestos Coordi- all disciplines required under section nator, 1200 Sixth Ave., Seattle, WA 98101, 206(b)(2) of TSCA, 15 U.S.C. 2646(b)(2), to seek (206) 553-4762. EPA approval for those disciplines the State EPA maintains a listing of all those States does accredit. As States establish accredita- that have applied for and received EPA ap- tion requirements for the remaining dis- proval for having accreditation requirements ciplines, the requested information outlined that are at least as stringent as the MAP for below should be submitted to EPA as soon as one or more disciplines. Any training courses

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approved by an EPA-approved State Pro- 4. The names and qualifications of all gram are considered to be EPA-approved for course instructors. Instructors must have purposes of accreditation. academic and/or field experience in asbestos abatement. III. Approval of Training Courses 5. A description of and an example of the Individuals or groups wishing to sponsor numbered certificates issued to students who training courses for disciplines required to complete the refresher course and pass the be accredited under section 206(b)(1)(A) of examination, if required. TSCA, 15 U.S.C. 2646(b)(1)(A), may apply for C. Withdrawal of Training Course Approval approval from States that have accreditation program requirements that are at least as States must establish criteria and proce- stringent as this MAP. For a course to re- dures for suspending or withdrawing ap- ceive approval, it must meet the require- proval from accredited training programs. ments for the course as outlined in this States should follow their own administra- MAP, and any other requirements imposed tive procedures in pursuing actions for sus- by the State from which approval is being pension or withdrawal of approval of train- sought. Courses that have been approved by ing programs. At a minimum, the criteria a State with an accreditation program at shall include: least as stringent as this MAP are approved (1) Misrepresentation of the extent of a under section 206(a) of TSCA, 15 U.S.C. training course’s approval by a State or 2646(a), for that particular State, and also for EPA; any other State that does not have an ac- (2) Failure to submit required information creditation program as stringent as this or notifications in a timely manner; MAP. (3) Failure to maintain requisite records; (4) Falsification of accreditation records, A. Initial Training Course Approval instructor qualifications, or other accredita- A training provider must submit the fol- tion information; or lowing minimum information to a State as (5) Failure to adhere to the training stand- part of its application for the approval of ards and requirements of the EPA MAP or each training course: State Accreditation Program, as appro- 1. The course provider’s name, address, and priate. telephone number. In addition to the criteria listed above, 2. A list of any other States that currently EPA may also suspend or withdraw a train- approve the training course. ing course’s approval where an approved 3. The course curriculum. training course instructor, or other person 4. A letter from the provider of the train- with supervisory authority over the delivery ing course that clearly indicates how the of training has been found in violation of course meets the MAP requirements for: other asbestos regulations administered by a. Length of training in days. EPA. An administrative or judicial finding of b. Amount and type of hands-on training. violation, or execution of a consent agree- c. Examination (length, format, and pass- ment and order under 40 CFR 22.18, con- ing score). stitutes evidence of a failure to comply with d. Topics covered in the course. relevant statutes or regulations. States may 5. A copy of all course materials (student wish to adopt this criterion modified to in- manuals, instructor notebooks, handouts, clude their own asbestos statutes or regula- etc.). tions. EPA may also suspend or withdraw ap- 6. A detailed statement about the develop- proval of training programs where a training ment of the examination used in the course. provider has submitted false information as 7. Names and qualifications of all course a part of the self-certification required under instructors. Instructors must have academic Unit V.B. of the revised MAP. and/or field experience in asbestos abate- Training course providers shall permit rep- ment. resentatives of EPA or the State which ap- 8. A description of and an example of the proved their training courses to attend, numbered certificates issued to students who evaluate, and monitor any training course attend the course and pass the examination. without charge. EPA or State compliance inspection staff are not required to give ad- B. Refresher Training Course Approval vance notice of their inspections. EPA may The following minimum information is resuspend or withdraw State or EPA approval quired for approval of refresher training of a training course based upon the criteria courses by States: specified in this Unit III.C. 1. The length of training in half-days or IV. EPA Procedures for Suspension or Revoca- days. tion of Accreditation or Training Course Ap- 2. The topics covered in the course. proval. 3. A copy of all course materials (student manuals, instructor notebooks, handouts, A. If the Administrator decides to suspend etc.). or revoke the accreditation of any person or

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suspend or withdraw the approval of a train- at the same time the emergency suspension ing course, the Administrator will notify the notice is issued. affected entity of the following: E. Any notice, decision, or order issued by 1. The grounds upon which the suspension, the Administrator under this section, and revocation, or withdrawal is based. any documents filed by an accredited person 2. The time period during which the sus- or approved training course provider in a pension, revocation, or withdrawal is effec- hearing under this section, shall be available tive, whether permanent or otherwise. to the public except as otherwise provided by 3. The conditions, if any, under which the section 14 of TSCA or by 40 CFR part 2. Any affected entity may receive accreditation or such hearing at which oral testimony is pre- approval in the future. sented shall be open to the public, except 4. Any additional conditions which the Ad- that the Presiding Officer may exclude the ministrator may impose. public to the extent necessary to allow pres- 5. The opportunity to request a hearing entation of information which may be enti- prior to final Agency action to suspend or re- tled to confidential treatment under section voke accreditation or suspend or withdraw 14 of TSCA or 40 CFR part 2. approval. B. If a hearing is requested by the accred- V. Implementation Schedule ited person or training course provider pur- The various requirements of this MAP be- suant to the preceding paragraph, the Ad- come effective in accordance with the fol- ministrator will: lowing schedules: 1. Notify the affected entity of those assertions of law and fact upon which the action A. Requirements applicable to State to suspend, revoke, or withdraw is based. Programs 2. Provide the affected entity an oppor- 1. Each State shall adopt an accreditation tunity to offer written statements of facts, plan that is at least as stringent as this MAP explanations, comments, and arguments rel- within 180 days after the commencement of evant to the proposed action. the first regular session of the legislature of 3. Provide the affected entity such other the State that is convened on or after April procedural opportunities as the Adminis- 4, 1994. trator may deem appropriate to ensure a fair 2. If a State has adopted an accreditation and impartial hearing. plan at least as stringent as this MAP as of 4. Appoint an EPA attorney as Presiding April 4, 1994, the State may continue to: Officer to conduct the hearing. No person a. Conduct TSCA training pursuant to this shall serve as Presiding Officer if he or she MAP. has had any prior connection with the spe- b. Approve training course providers to cific case. conduct training and to issue accreditation C. The Presiding Officer appointed pursu- that satisfies the requirements for TSCA ac- ant to the preceding paragraph shall: creditation under this MAP. 1. Conduct a fair, orderly, and impartial c. Issue accreditation that satisfies the re- hearing, without unnecessary delay. quirements for TSCA accreditation under 2. Consider all relevant evidence, expla- this MAP. nation, comment, and argument submitted 3. A State that had complied with an ear- pursuant to the preceding paragraph. lier version of the MAP, but has not adopted 3. Promptly notify the affected entity of an accreditation plan at least as stringent as his or her decision and order. Such an order this MAP by April 4, 1994, may: is a final Agency action. a. Conduct TSCA training which remains D. If the Administrator determines that in compliance with the requirements of Unit the public health, interest, or welfare war- V.B. of this MAP. After such training has rants immediate action to suspend the ac- been self-certified in accordance with Unit creditation of any person or the approval of V.B. of this MAP, the State may issue ac- any training course provider, the Adminis- creditation that satisfies the requirement for trator will: TSCA accreditation under this MAP. 1. Notify the affected entity of the grounds b. Sustain its approval for any training upon which the emergency suspension is course providers to conduct training and based; issue TSCA accreditation that the State had 2. Notify the affected entity of the time pe- approved before April 4, 1994, and that re- riod during which the emergency suspension main in compliance with Unit V.B. of this is effective. MAP. 3. Notify the affected entity of the Admin- c. Issue accreditation pursuant to an ear- istrator’s intent to suspend or revoke accred- lier version of the MAP that provisionally itation or suspend or withdraw training satisfies the requirement for TSCA accredi- course approval, as appropriate, in accord- tation until October 4, 1994. ance with Unit IV.A. above. If such suspen- Such a State may not approve new TSCA sion, revocation, or withdrawal notice has training course providers to conduct training not previously been issued, it will be issued or to issue TSCA accreditation that satisfies

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the requirements of this MAP until the ment signed by an authorized representative State adopts an accreditation plan that is at of the training provider: ‘‘Under civil and least as stringent as this MAP. criminal penalties of law for the making or 4. A State that had complied with an ear- submission of false or fraudulent statements lier version of the MAP, but fails to adopt a or representations (18 U.S.C. 1001 and 15 plan as stringent as this MAP by the dead- U.S.C. 2615), I certify that the training de- line established in Unit V.A.1., is subject to scribed in this submission complies with all the following after that deadline date: applicable requirements of Title II of TSCA, a. The State loses any status it may have 40 CFR part 763, Appendix C to Subpart E, as held as an EPA-approved State for accredita- revised, and any other applicable Federal, tion purposes under section 206 of TSCA, 15 state, or local requirements.’’ A consolidated U.S.C. 2646. self-certification submission from each b. All training course providers approved training provider that addresses all of its ap- by the State lose State approval to conduct proved training courses is permissible and training and issue accreditation that satis- encouraged. fies the requirements for TSCA accreditation The self-certification must be sent via reg- under this MAP. istered mail, to EPA Headquarters at the fol- c. The State may not: lowing address: Attn. Self-Certification Pro- i. Conduct training for accreditation pur- gram, Field Programs Branch, Chemical poses under section 206 of TSCA, 15 U.S.C. Management Division (7404), Office of Pollu- 2646. tion Prevention and Toxics, Environmental ii. Approve training course providers to Protection Agency, 1200 Pennsylvania Ave., conduct training or issue accreditation that NW., Washington, DC 20460. A duplicate copy satisfies the requirements for TSCA accredi- of the complete submission must also be sent tation; or to any States from which approval had been iii. Issue accreditation that satisfies the obtained. requirement for TSCA accreditation. The timely receipt of a complete self-cer- EPA will extend EPA-approval to any tification by EPA and all approving States training course provider that loses State ap- shall have the effect of extending approval proval because the State does not comply under this MAP to the training courses of- with the deadline, so long as the provider is fered by the submitting provider. If a self- in compliance with Unit V.B. of this MAP, certification is not received by the approving and the provider is approved by a State that government bodies on or before the due date, had complied with an earlier version of the the affected training course is not approved MAP as of the day before the State loses its under this MAP. Such training providers EPA approval. must then reapply for approval of these 5. A State that does not have an accredita- training courses pursuant to the procedures tion program that satisfies the requirements outlined in Unit III. for TSCA accreditation under either an earlier version of the MAP or this MAP, may C. Requirements applicable to Accredited not: Persons. a. Conduct training for accreditation purposes under section 206 of TSCA, 15 U.S.C. Persons accredited by a State with an ac- 2646; creditation program no less stringent than b. Approve training course providers to an earlier version of the MAP or by an EPA- conduct training or issue accreditation that approved training provider as of April 3, 1994, satisfies the requirements for TSCA accredi- are accredited in accordance with the re- tation; or quirements of this MAP, and are not re- c. Issue accreditation that satisfies the required to retake initial training. They must quirement for TSCA accreditation. continue to comply with the requirements for annual refresher training in Unit I.D. of B. Requirements applicable to Training the revised MAP. Courses and Providers D. Requirements applicable to Non- As of October 4, 1994, an approved training Accredited Persons. provider must certify to EPA and to any State that has approved the provider for In order to perform work requiring accredi- TSCA accreditation, that each of the pro- tation under TSCA Title II, persons who are vider’s training courses complies with the re- not accredited by a State with an accredita- quirements of this MAP. The written sub- tion program no less stringent than an ear- mission must document in specific detail the lier version of the MAP or by an EPA-ap- changes made to each training course in proved training provider as of April 3, 1994, order to comply with the requirements of must comply with the upgraded training re- this MAP and clearly state that the provider quirements of this MAP by no later than Oc- is also in compliance with all other require- tober 4, 1994. Non-accredited persons may ob- ments of this MAP, including the new rec- tain initial accreditation on a provisional ordkeeping and certificate provisions. Each basis by successfully completing any of the submission must include the following state- training programs approved under an earlier

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version of the MAP, and thereby perform Region II work during the first 6 months after this Asbestos NESHAPs Contact, Air & Waste MAP takes effect. However, by October 4, Management Division, USEPA, Region II, 26 1994, these persons must have successfully Federal Plaza, New York, NY 10007, (212) 264– completed an upgraded training program 6770. that fully complies with the requirements of this MAP in order to continue to perform Region III work requiring accreditation under section 206 of TSCA, 15 U.S.C. 2646. Asbestos NESHAPs Contact, Air Manage- ment Division, USEPA, Region III, 841 Chest- [59 FR 5251, Feb. 3, 1994, as amended at 60 FR nut Street, Philadelphia, PA 19107, (215) 597– 31922, June 19, 1995; 70 FR 59889, Oct. 13, 2005; 9325. 75 FR 69353, Nov. 12, 2010] Region IV APPENDIX D TO SUBPART E OF PART Asbestos NESHAPs Contact, Air, Pesticide 763—TRANSPORT AND DISPOSAL OF & Toxic Management, USEPA, Region IV, ASBESTOS WASTE 345 Courtland Street, NE., Atlanta, GA 30365, (404) 347–4298. For the purposes of this appendix, transport is defined as all activities from receipt Region V of the containerized asbestos waste at the Asbestos NESHAPs Contact, Air Manage- generation site until it has been unloaded at ment Division, USEPA, Region V, 77 West the disposal site. Current EPA regulations Jackson Boulevard, Chicago, IL 60604, (312) state that there must be no visible emissions 353–6793. to the outside air during waste transport. However, recognizing the potential hazards Region VI and subsequent liabilities associated with Asbestos NESHAPs Contact, Air & Waste exposure, the following additional pre- Management Division, USEPA, Region VI, cautions are recommended. 1445 Ross Avenue, Dallas, TX 75202, (214) 655– Recordkeeping. Before accepting wastes, a 7229. transporter should determine if the waste is properly wetted and containerized. The Region VII transporter should then require a chain-of- custody form signed by the generator. A Asbestos NESHAPs Contact, Air & Waste chain-of-custody form may include the name Management Division, USEPA, Region VII, and address of the generator, the name and 726 Minnesota Avenue, Kansas City, KS 66101, address of the pickup site, the estimated (913) 236–2896. quantity of asbestos waste, types of con- Region VIII tainers used, and the destination of the waste. The chain-of-custody form should Asbestos NESHAPs Contact, Air & Waste then be signed over to a disposal site oper- Management Division, USEPA, Region VIII, ator to transfer responsibility for the asbes- 999 18th Street, Suite 500, Denver, CO 80202, tos waste. A copy of the form signed by the (303) 293–1814. disposal site operator should be maintained by the transporter as evidence of receipt at Region IX the disposal site. Asbestos NESHAPs Contact, Air Division, Waste handling. A transporter should en- USEPA, Region IX, 75 Hawthorne Street, sure that the asbestos waste is properly con- San Francisco, CA 94105, (415) 972–3989. tained in leak-tight containers with appropriate labels, and that the outside surfaces of Region X the containers are not contaminated with as- Asbestos NESHAPs Contact, Air & Toxics bestos debris adhering to the containers. If Management Division, USEPA, Region X, there is reason to believe that the condition 1200 Sixth Avenue, Seattle, WA 98101, (206) of the asbestos waste may allow significant 442–2724. fiber release, the transporter should not ac- Once the transporter is satisfied with the cept the waste. Improper containerization of condition of the asbestos waste and agrees to wastes is a violation of the NESHAPs regula- handle it, the containers should be loaded tion and should be reported to the appro- into the transport vehicle in a careful man- priate EPA Regional Asbestos NESHAPs ner to prevent breaking of the containers. contact below: Similarly, at the disposal site, the asbestos Region I waste containers should be transferred carefully to avoid fiber release. Asbestos NESHAPs Contact, Air Manage- Waste transport. Although there are no reg- ment Division, USEPA, Region I, JFK Fed- ulatory specifications regarding the trans- eral Building, Boston, MA 02203, (617) 223– port vehicle, it is recommended that vehicles 3266. used for transport of containerized asbestos

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waste have an enclosed carrying compart- tainerized, the landfill operator should thor- ment or utilize a canvas covering sufficient oughly soak the asbestos with a water spray to contain the transported waste, prevent prior to unloading, rinse out the truck, and damage to containers, and prevent fiber re- immediately cover the wastes with non- lease. Transport of large quantities of asbes- asbestos material prior to compacting the tos waste is commonly conducted in a 20- waste in the landfill. cubic-yard ‘‘roll off’’ box, which should also Waste deposition and covering. Recognizing be covered. Vehicles that use compactors to the health dangers associated with asbestos reduce waste volume should not be used be- exposure, the following procedures are rec- cause these will cause the waste containers ommended to augment current federal re- to rupture. Vacuum trucks used to transport quirements: waste slurry must be inspected to ensure • Designate a separate area for asbestos that water is not leaking from the truck. waste disposal. Provide a record for future Disposal involves the isolation of asbestos landowners that asbestos waste has been bur- waste material in order to prevent fiber re- ied there and that it would be hazardous to lease to air or water. Landfilling is rec- attempt to excavate that area. (Future regu- ommended as an environmentally sound iso- lations may require property deeds to iden- lation method because asbestos fibers are tify the location of any asbestos wastes and virtually immobile in soil. Other disposal warn against excavation.) techniques such as incineration or chemical • Prepare a separate trench to receive as- treatment are not feasible due to the unique bestos wastes. The size of the trench will de- properties of asbestos. EPA has established pend upon the quantity and frequency of as- asbestos disposal requirements for active and bestos waste delivered to the disposal site. inactive disposal sites under NESHAPs (40 The trenching technique allows application CFR Part 61, subpart M) and specifies gen- of soil cover without disturbing the asbestos eral requirements for solid waste disposal waste containers. The trench should be under RCRA (40 CFR Part 257). Advance EPA ramped to allow the transport vehicle to notification of the intended disposal site is back into it, and the trench should be as nar- required by NESHAPs. row as possible to reduce the amount of Selecting a disposal facility. An acceptable cover required. If possible, the trench should disposal facility for asbestos wastes must ad- be aligned perpendicular to prevailing winds. here to EPA’s requirements of no visible • Place the asbestos waste containers into emissions to the air during disposal, or mini- the trench carefully to avoid breaking them. mizing emissions by covering the waste Be particularly careful with plastic bags be- within 24 hours. The minimum required cause when they break under pressure asbes- cover is 6 inches of nonasbestos material, tos particles can be emitted. normally soil, or a dust-suppressing chem- • Completely cover the containerized ical. In addition to these Federal require- waste within 24 hours with a minimum of 6 ments, many state or local government inches of nonasbestos material. Improperly agencies require more stringent handling containerized waste is a violation of the procedures. These agencies usually supply a NESHAPs and EPA should be notified. list of ‘‘approved’’ or licensed asbestos dis- However, if improperly containerized posal sites upon request. Solid waste control waste is received at the disposal site, it agencies are listed in local telephone direc- should be covered immediately after unload- tories under state, county, or city headings. ing. Only after the wastes, including prop- A list of state solid waste agencies may be erly containerized wastes, are completely obtained by calling the RCRA hotline: 1–800– covered, can the wastes be compacted or 424–9346 (382–3000 in Washington, DC). Some other heavy equipment run over it. During landfill owners or operators place special re- compacting, avoid exposing wastes to the air quirements on asbestos waste, such as plac- or tracking asbestos material away from the ing all bagged waste into 55-gallon metal trench. drums. Therefore, asbestos removal contrac- • For final closure of an area containing tors should contact the intended landfill be- asbestos waste, cover with at least an addi- fore arriving with the waste. tional 30 inches of compacted nonasbestos Receiving asbestos waste. A landfill approved material to provide a 36-inch final cover. To for receipt of asbestos waste should require control erosion of the final cover, it should notification by the waste hauler that the be properly graded and vegetated. In areas of load contains asbestos. The landfill operator the United States where excessive soil ero- should inspect the loads to verify that asbes- sion may occur or the frost line exceeds 3 tos waste is properly contained in leak-tight feet, additional final cover is recommended. containers and labeled appropriately. The In desert areas where vegetation would be appropriate EPA Regional Asbestos difficult to maintain, 3–6 inches of well grad- NESHAPs Contact should be notified if the ed crushed rock is recommended for place- landfill operator believes that the asbestos ment on top of the final cover. waste is in a condition that may cause sig- Controlling public access. Under the current nificant fiber release during disposal. In situ- NESHAPs regulation, EPA does not require ations when the wastes are not properly con- that a landfill used for asbestos disposal use

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warning signs or fencing if it meets the re- phology and color are also observed. A retar- quirement to cover asbestos wastes. How- dation plate is placed in the polarized light ever, under RCRA, EPA requires that access path for determination of the sign of elon- be controlled to prevent exposure of the pub- gation using orthoscopic illumination. Ori- lic to potential health and safety hazards at entation of the two filters such that their vi- the disposal site. Therefore, for liability pro- bration planes are perpendicular (crossed tection of operators of landfills that handle polars) allows observation of the asbestos, fencing and warning signs are rec- birefringence and extinction characteristics ommended to control public access when of anisotropic particles. natural barriers do not exist. Access to a Quantitative analysis involves the use of landfill should be limited to one or two en- point counting. Point counting is a standard trances with gates that can be locked when technique in petrography for determining left unattended. Fencing should be installed the relative areas occupied by separate min- around the perimeter of the disposal site in erals in thin sections of rock. Background a manner adequate to deter access by the information on the use of point counting 2 general public. Chain-link fencing, 6-ft high and the interpretation of point count data 3 and topped with a barbed wire guard, should is available. be used. More specific fencing requirements This method is applicable to all bulk sam- may be specified by local regulations. Warn- ples of friable insulation materials sub- ing signs should be displayed at all entrances and at intervals of 330 feet or less along the mitted for identification and quantitation of property line of the landfill or perimeter of asbestos components. the sections where asbestos waste is depos- 1.2 Range ited. The sign should read as follows: ASBESTOS WASTE DISPOSAL SITE The point counting method may be used BREATHING ASBESTOS DUST MAY for analysis of samples containing from 0 to CAUSE LUNG DISEASE AND CANCER 100 percent asbestos. The upper detection limit is 100 percent. The lower detection Recordkeeping. For protection from liabil- limit is less than 1 percent. ity, and considering possible future requirements for notification on disposal site deeds, 1.3 Interferences a landfill owner should maintain documentation of the specific location and quantity of Fibrous organic and inorganic constituents the buried asbestos wastes. In addition, the of bulk samples may interfere with the iden- estimated depth of the waste below the sur- tification and quantitation of the asbestos face should be recorded whenever a landfill mineral content. Spray-on binder materials section is closed. As mentioned previously, may coat fibers and affect color or obscure such information should be recorded in the optical characteristics to the extent of land deed or other record along with a notice masking fiber identity. Fine particles of warning against excavation of the area. other materials may also adhere to fibers to an extent sufficient to cause confusion in [52 FR 41897, Oct. 30, 1987, as amended at 62 identification. Procedures that may be used FR 1834, Jan. 14, 1997; 75 FR 69353, Nov. 12, for the removal of interferences are pre- 2010] sented in Section 1.7.2.2.

APPENDIX E TO SUBPART E OF PART 1.4 Precision and Accuracy 763—INTERIM METHOD OF THE DE- Adequate data for measuring the accuracy TERMINATION OF ASBESTOS IN BULK and precision of the method for samples with INSULATION SAMPLES various matrices are not currently available. Data obtained for samples containing a sin- SECTION 1. POLARIZED LIGHT MICROSCOPY gle asbestos type in a simple matrix are 1.1 Principle and Applicability available in the EPA report Bulk Sample Analysis for Asbestos Content: Evaluation of Bulk samples of building materials taken the Tentative Method.4 for asbestos identification are first examined for homogeneity and preliminary fiber iden- 1.5 Apparatus tification at low magnification. Positive identification of suspect fibers is made by 1.5.1 Sample Analysis analysis of subsamples with the polarized light microscope. A low-power binocular microscope, pref- The principles of optical mineralogy are erably stereoscopic, is used to examine the well established. 1,2 A light microscope bulk insulation sample as received. equipped with two polarizing filters is used • Microscope: binocular, 10–45X (approxi- to observe specific optical characteristics of mate). a sample. The use of plane polarized light al- • Light Source: incandescent or fluorescent. lows the determination of refractive indices • Forceps, Dissecting Needles, and Probes along specific crystallographic axes. Mor- • Glassine Paper or Clean Glass Plate

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Compound microscope requirements: A po- analyst and contamination of samples by larized light microscope complete with po- airborne fibers. larizer, analyzer, port for wave retardation plate, 360° graduated rotating stage, substage 1.7.1 Sampling condenser, lamp, and lamp iris. Samples for analysis of asbestos content • Polarized Light Microscope: described above. shall be taken in the manner prescribed in • Objective Lenses: 10X, 20X, and 40X or near Reference 5 and information on design of equivalent. sampling and analysis programs may be • Dispersion Staining Objective Lens (optional) found in Reference 6. If there are any ques- • Ocular Lens: 10X minimum. tions about the representative nature of the • Eyepiece Reticle: cross hair or 25 point sample, another sample should be requested Chalkley Point Array. before proceeding with the analysis. • Compensator Plate: 550 millimicron retardation. 1.7.2 Analysis 1.5.2 Sample Preparation 1.7.2.1 Gross Examination Sample preparation apparatus require- Bulk samples of building materials taken ments will depend upon the type of insula- for the identification and quantitation of as- tion sample under consideration. Various bestos are first examined for homogeneity at physical and/or chemical means may be em- low magnification with the aid of a ployed for an adequate sample assessment. stereomicroscope. The core sample may be • Ventilated Hood or negative pressure glove examined in its container or carefully re- box. moved from the container onto a glassine • Microscope Slides transfer paper or clean glass plate. If pos- • Coverslips sible, note is made of the top and bottom ori- • Mortar and Pestle: agate or porcelain. (op- entation. When discrete strata are identified, tional) each is treated as a separate material so that • Wylie Mill (optional) fibers are first identified and quantified in • Beakers and Assorted Glassware (optional) that layer only, and then the results for each • Certrifuge (optional) layer are combined to yield an estimate of • Filtration apparatus (optional) asbestos content for the whole sample. • Low temperature asher (optional) 1.7.2.2 Sample Preparation 1.6 Reagents Bulk materials submitted for asbestos 1.6.1 Sample Preparation analysis involve a wide variety of matrix materials. Representative subsamples may • Distilled Water (optional) not be readily obtainable by simple means in • Dilute CH3COOH: ACS reagent grade (op- heterogeneous materials, and various steps tional) may be required to alleviate the difficulties • Dilute HCl: ACS reagent grade (optional) encountered. In most cases, however, the • (NaPO ) (optional) Sodium metaphosphate 3 6 best preparation is made by using forceps to 1.6.2 Analytical Reagents sample at several places from the bulk material. Forcep samples are immersed in a re- Refractive Index Liquids: 1.490–1.570, 1.590– fractive index liquid on a microscope slide, 1.720 in increments of 0.002 or 0.004. teased apart, covered with a cover glass, and • Refractive Index Liquids for Dispersion Stain- observed with the polarized light micro- ing: high-dispersion series, 1.550, 1.605, 1.630 scope. (optional). Alternatively, attempts may be made to • UICC Asbestos Reference Sample Set: Avail- homogenize the sample or eliminate inter- able from: UICC MRC Pneumoconiosis ferences before further characterization. The Unit, Llandough Hospital, Penarth, selection of appropriate procedures is de- Glamorgan CF6 1XW, UK, and commercial pendent upon the samples encountered and distributors. personal preference. The following are pre- • Tremolite-asbestos (source to be determined) sented as possible sample preparation steps. • Actinolite-asbestos (source to be determined) A mortar and pestle can sometimes be used in the size reduction of soft or loosely bound 1.7 Procedures materials though this may cause matting of NOTE: Exposure to airborne asbestos fibers some samples. Such samples may be reduced is a health hazard. Bulk samples submitted in a Wylie mill. Apparatus should be clean for analysis are usually friable and may re- and extreme care exercised to avoid cross- lease fibers during handling or matrix reduc- contamination of samples. Periodic checks tion steps. All sample and slide preparations of the particle sizes should be made during should be carried out in a ventilated hood or the grinding operation so as to preserve any glove box with continuous airflow (negative fiber bundles present in an identifiable form. pressure). Handling of samples without these These procedures are not recommended for precautions may result in exposure of the samples that contain amphibole minerals or

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vermiculite. Grinding of amphiboles may re- of 500 °C or lower. Temperatures of 550 °C or sult in the separation of fiber bundles or the higher will cause dehydroxylation of the as- production of cleavage fragments with asbestos minerals, resulting in changes of the pect ratios greater than 3:1. Grinding of refractive index and other key parameters. If vermiculite may also produce fragments a muffle furnace is to be used, the furnace with aspect ratios greater than 3:1. thermostat should be checked and calibrated Acid treatment may occasionally be re- to ensure that samples will not be heated at quired to eliminate interferences. Calcium temperatures greater than 550 °C. carbonate, gypsum, and bassanite (plaster) Ashing and acid treatment of samples are frequently present in sprayed or should not be used as standard procedures. In trowelled insulations. These materials may order to monitor possible changes in fiber be removed by treatment with warm dilute characteristics, the material should be acetic acid. Warm dilute hydrochloric acid viewed microscopically before and after any may also be used to remove the above mate- sample preparation procedure. Use of these rials. If acid treatment is required, wash the procedures on samples to be used for quan- sample at least twice with distilled water, titation requires a correction for percent being careful not to lose the particulates weight loss. during decanting steps. Centrifugation or filtration of the suspension will prevent signifi- 1.7.2.3 Fiber Identification cant fiber loss. The pore size of the filter Positive identification of asbestos requires should be 0.45 micron or less. Caution: prolonged acid contact with the sample may the determination of the following optical alter the optical characteristics of chrysotile properties. • fibers and should be avoided. Morphology • Coatings and binding materials adhering to Color and pleochroism • fiber surfaces may also be removed by treat- Refractive indices • ment with sodium metaphosphate.7 Add 10 Birefringence mL of 10g/L sodium metaphosphate solution • Extinction characteristics to a small (0.1 to 0.5 mL) sample of bulk ma- • Sign of elongation terial in a 15-mL glass centrifuge tube. For Table 1–1 lists the above properties for com- approximately 15 seconds each, stir the mix- mercial asbestos fibers. Figure 1–1 presents a ture on a vortex mixer, place in an ultra- flow diagram of the examination procedure. sonic bath and then shake by hand. Repeat Natural variations in the conditions under the series. Collect the dispersed solids by which deposits of asbestiform minerals are centrifugation at 1000 rpm for 5 minutes. formed will occasionally produce exceptions Wash the sample three times by suspending to the published values and differences from in 10 mL distilled water and recentrifuging. the UICC standards. The sign of elongation is After washing, resuspend the pellet in 5 mL determined by use of the compensator plate distilled water, place a drop of the suspen- and crossed polars. Refractive indices may sion on a microscope slide, and dry the slide be determined by the Becke line test. Alter- at 110 °C. natively, dispersion staining may be used. In samples with a large portion of cellu- Inexperienced operators may find that the losic or other organic fibers, it may be useful dispersion staining technique is more easily to ash part of the sample and view the res- learned, and should consult Reference 9 for idue. Ashing should be performed in a low guidance. Central stop dispersion staining temperature asher. Ashing may also be per- colors are presented in Table 1–2. Available formed in a muffle furnace at temperatures high-dispersion (HD) liquids should be used.

TABLE 1–1—OPTICAL PROPERTIES OF ASBESTOC FIBERS

Refrac- tive indices b a Birefring- Sign of Mineral Morphology, color ence Extinction elonation a g

Chrysotile Wavy fibers. Fiber bundles have 1.493–1.560 1.517– .008 | to fiber + (asbestiform splayed ends and ‘‘kinks’’. Aspect 1.562f length. (length serpentine). ratio typically >10:1. Colorless 3, (nor- slow) nonpleochroic. mally 1.556). Amosite Straight, rigid fibers. Aspect ratio typi- 1.635–1.696 1.655– .020–.033 | to fiber + (asbestiform cally >10:1. Colorless to brown, 1.729 f length. (length grunerite). nonpleochroic or weakly so. Opaque (nor- slow) inclusions may be present. mally 1.696– 1.710.

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TABLE 1–1—OPTICAL PROPERTIES OF ASBESTOC FIBERS—Continued

Refrac- tive indices b a Birefring- Sign of Mineral Morphology, color ence Extinction elonation a g

Crocidolite Straight, rigid fibers. Thick fibers and 1.654–1.701 1.668– .014–.016 | to fiber ¥ (asbestiform bundles common, blue to purple- 1.7173e length. (length fast) Riebeckite). blue in color. Pleochroic. (nor- Birefringence is generally masked by mally blue color. close to 1.700). Anthophyllite- Straight fibers and acicular cleavage 1.596–1.652 1.615– .019–.024 | to fiber + asbestos. fragments.d Some composite fibers. 1.676 f. length. (length Aspect ratio <10:1. Colorless to light slow) brown. Tremolite-actin- Normally present as acicular or pris- 1.599–1.668 1.622– .023–.020 Oblique + olite-asbes- matic cleavage fragments.d Single 1.688 f. extinc- (length tos. crystals predominate, aspect ratio tion, 10– slow) <10:1. Colorless to pale green. 20° for fragments. Com- posite fibers show | extinction.

a From reference 5; colors cited are seen by observation with plane polarized light. b From references 5 and 8. c Fibers subjected to heating may be brownish. d Fibers defined as having aspect ratio >3:1. e to fiber length. f |To fiber length.

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TABLE 1–2—CENTRAL STOP DISPERSION • A reticle with 25 points (Chalkley Point STAINING COLORS A Array) and counting at least 2 randomly selected fields. Mineral RI Liquid h h| For samples with mixtures of isotropic and anisotropic materials present, viewing the HD Chrysotile ..... 1 .550 Blue ...... Blue-ma- sample with slightly uncrossed polars or the genta Amosite ...... 1 .680 Blue-ma- Golden-yel- addition of the compensator plate to the po- genta to low larized light path will allow simultaneous pale blue. discrimination of both particle types. Quan- 1.550 HD Yellow to Yellow to titation should be performed at 100X or at white. white the lowest magnification of the polarized Crocidolite b .. 1 .700 Red magenta Blue-ma- light microscope that can effectively distin- genta guish the sample components. Confirmation HD 1.550 Yellow to Yellow to of the quantitation result by a second ana- white. white lyst on some percentage of analyzed samples Anthophyllite 1 .605HD Blue ...... Gold to gold- magenta should be used as standard quality control Tremolite ...... 1.605 HD c Pale blue..... Gold procedure. Actinolite ...... 1.605 HD Gold-ma- Gold The percent asbestos is calculated as fol- genta to lows: blue. % asbestos=(a/n) 100% 1.630 HD c Magenta ...... Golden-yellow where a=number of asbestos counts, a From reference 9. b Blue absorption color. n=number of nonempty points counted (400). c Oblique extinction view. If a=0, report ‘‘No asbestos detected.’’ If 0< a≤3, report ‘‘<1% asbestos’’. 1.7.2.4 Quantitation of Asbestos Content The value reported should be rounded to Asbestos quantitation is performed by a the nearest percent. point-counting procedure or an equivalent 1.8 References estimation method. An ocular reticle (cross- hair or point array) is used to visually super- 1. Paul F. Kerr, Optical Mineralogy, 4th ed., impose a point or points on the microscope New York, McGraw-Hill, 1977. field of view. Record the number of points 2. E. M. Chamot and C. W. Mason, Hand- positioned directly above each kind of par- book of Chemical Microscopy, Volume One, 3rd ticle or fiber of interest. Score only points ed., New York: John Wiley & Sons, 1958. directly over asbestos fibers or nonasbestos 3. F. Chayes, Petrographic Modal Analysis: matrix material. Do not score empty points An Elementary Statistical Appraisal, New for the closest particle. If an asbestos fiber York: John Wiley & Sons, 1956. and a matrix particle overlap so that a point 4. E. P. Brantly, Jr., K. W. Gold, L. E. is superimposed on their visual intersection, Myers, and D. E. Lentzen, Bulk Sample Anal- a point is scored for both categories. Point ysis for Asbestos Content: Evaluation of the counting provides a determination of the Tentative Method, U.S. Environmental Pro- area percent asbestos. Reliable conversion of tection Agency, October 1981. area percent to percent of dry weight is not 5. U.S. Environmental Protection Agency, currently feasible unless the specific Asbestos-Containing Materials in School Build- gravities and relative volumes of the mate- ings: A Guidance Document, Parts 1 and 2, rials are known. EPA/OPPT No. C00090, March 1979. For the purpose of this method, ‘‘asbestos 6. D. Lucas, T. Hartwell, and A. V. Rao, As- fibers’’ are defined as having an aspect ratio bestos-Containing Materials in School Build- greater than 3:1 and being positively identi- ings: Guidance for Asbestos Analytical Pro- fied as one of the minerals in Table 1–1. grams, EPA 560/13–80–017A, U.S. Environ- A total of 400 points superimposed on ei- mental Protection Agency, December 1980, 96 ther asbestos fibers or nonasbestos matrix pp. material must be counted over at least eight 7. D. H. Taylor and J. S. Bloom, different preparations of representative sub- Hexametaphosphate pretreatment of insula- samples. Take eight forcep samples and tion samples for identification of fibrous mount each separately with the appropriate constituents, Microscope, 28, 1980. refractive index liquid. The preparation 8. W. J. Campbell, R. L. Blake, L. L. should not be heavily loaded. The sample Brown, E. E. Cather, and J. J. Sjoberg. Se- should be uniformly dispersed to avoid over- lected Silicate Minerals and Their Asbestiform lapping particles and allow 25–50 percent Varieties: Mineralogical Definitions and Identi- empty area within the fields of view. Count fication-Characterization, U.S. Bureau of 50 nonempty points on each preparation, Mines Information Circular 8751, 1977. using either 9. Walter C. McCrone, Asbestos Particle • A cross-hair reticle and mechanical stage; Atlas, Ann Arbor: Ann Arbor Science Pub- or lishers, June 1980.

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SECTION 2. X-RAY POWDER DIFFRACTION For qualitative analysis by XRD methods, samples are initially scanned over limited 2.1 Principle and Applicability diagnostic peak regions for the serpentine ˚ ˚ The principle of X-ray powder diffraction (∼7.4 A) and amphibole (8.2–8.5 A) minerals (XRD) analysis is well established. 1,2 Any (Table 2–2). Standard slow-scanning methods solid, crystalline material will diffract an for bulk sample analysis may be used for ma- impingent beam of parallel, monochromatic terials shown by PLM to contain significant X-rays whenever Bragg’s Law, amounts of asbestos (>5–10 percent). Detec- tion of minor or trace amounts of asbestos λ = 2d sin q, may require special sample preparation and is satisfied for a particular set of planes in step-scanning analysis. All samples that ex- the crystal lattice, where hibit diffraction peaks in the diagnostic re- ˚ λ = the X-ray wavelength, A; gions for asbestiform minerals are submitted d = the interplanar spacing of the set of re- to a full (5°–60° 2q; 1° 2q/min) qualitative XRD ˚ flecting lattice planes, A; and scan, and their diffraction patterns are com- q = the angle of incidence between the X-ray pared with standard reference powder dif- beam and the reflecting lattice planes. fraction patterns 3 to verify initial peak as- By appropriate orientation of a sample rel- signments and to identify possible matrix ative to the incident X-ray beam, a diffrac- interferences when subsequent quantitative tion pattern can be generated that, in most analysis will be performed. cases, will be uniquely characteristic of both the chemical composition and structure of TABLE 2–1—THE ASBESTOS MINERALS AND the crystalline phases present. THEIR NONASBESTIFORM ANALOGS Unlike optical methods of analysis, however, XRD cannot determine crystal mor- Asbestiform Nonasbestiform phology. Therefore, in asbestos analysis, XRD does not distinguish between fibrous SERPENTINE and nonfibrous forms of the serpentine and Chrysotile Antigorite, lizardite amphibole minerals (Table 2–1). However, AMPHIBOLE when used in conjunction with optical meth- Anthophyllite asbestos Anthophyllite ods such as polarized light microscopy Cummingtonite-grunerite Cummingtonite-grunerite (PLM), XRD techniques can provide a reli- asbestos (‘‘Amosite’’) able analytical method for the identification Crocidolite Riebeckite and characterization of asbestiform minerals Tremolite asbestos Tremolite Actinolite asbestos Actinolite in bulk materials.

TABLE 2–2—PRINCIPAL LATTICE SPACINGS OF ASBESTIFORM MINERALS A

Principal d-spacings (A˚ ) and relative intensities Minerals JCPDS Powder diffraction file 3 number

b Chrysotile ...... 7 .37100 3 .6570 4 .5750 21–543 7.36100 .. 3.6680 2.4565 25–645 7.10100 .. 2.3380 3.5570 22–1162 (theoretical) ‘‘Amosite’’ ...... 8.33 100 3 .0670 2.756 70 17–745 (nonfibrous) 8.22100 .. 3.06085 3.2570 27–1170 (UICC) Anthophyllite ...... 3 .05100 3 .2460 8 .2655 9–455 3.06100 .. 8.3370 3.2350 16–401 (synthetic) Anthophyllite ...... 2 .72100 2 .54100 3 .48080 25–157 Crocidolite ...... 8 .35100 3 .1055 2.720 35 27–1415 (UICC) b Tremolite ...... 8.38 100 3 .12100 2 .70590 13–437 b 2.706100 3.1495 8.4340 20–1310 (synthetic) 3.13100 .. 2.70660 8.4440 23–666 (synthetic mixture with richterite) a This information is intended as a guide, only. Complete powder diffraction data, including mineral type and source, should be referred to, to ensure comparability of sample and reference materials where possible. Additional precision XRD data on amosite, crocidolite, tremolite, and chrysotile are available from the U.S. Bureaus of Mines.4 b Fibrosity questionable.

Accurate quantitative analysis of asbestos qualitative XRD analysis is selected for in bulk samples by XRD is critically depend- quantitation of each asbestiform mineral. A ent on particle size distribution, crystallite ‘‘thin-layer’’ method of analysis 5,6 is rec- size, preferred orientation and matrix ab- ommended in which, subsequent to sorption effects, and comparability of stand- comminution of the bulk material to ∼10 μm ard reference and sample materials. The by suitable cryogenic milling techniques, an most intense diffraction peak that has been accurately known amount of the sample is shown to be free from interference by prior deposited on a silver membrane filter. The

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mass of asbestiform material is determined • Gypsum has a major peak at 7.5 A˚ that by measuring the integrated area of the se- overlaps the 7.36 A˚ peak of chrysotile when lected diffraction peak using a step-scanning present as a major sample constituent. mode, correcting for matrix absorption ef- This may be removed by careful washing fects, and comparing with suitable calibra- with distilled water, or be heating to 300 °C tion standards. Alternative ‘‘thick-layer’’ or to convert gypsum to plaster of paris. bulk methods, 7,8 may be used for semi- • Cellulose has a broad peak that partially quantitative analysis. overlaps the secondary (3.66 A˚ ) chrysotile This XRD method is applicable as a con- peak.8 firmatory method for identification and • Overlap of major diagnostic peaks of the quantitation of asbestos in bulk material amphibole asbestos minerals, amosite, samples that have undergone prior analysis anthophyllite, crocidolite, and tremolite, by PLM or other optical methods. at approximately 8.3 A˚ and 3.1 A˚ causes mutual interference when these minerals 2.2 Range and Sensitivity occur in the presence of one another. In The range of the method has not been de- some instances, adquate resolution may be termined. attained by using step-scanning methods The sensitivity of the method has not been and/or by decreasing the collimator slit determined. It will be variable and depend- width at the X-ray port. ent upon many factors, including matrix ef- TABLE 2–3—COMMON CONSTITUENTS IN fects (absoprtion and interferences), diag- INSULATION AND WALL MATERIALS nostic reflections selected, and their relative intensities. A. Insulation materials Chrysotile 2.3 Limitations ‘‘Amosite’’ Crocidolite 2.3.1 Interferences *Rock wool Since the fibrous and nonfibrous forms of *Slag wool the serpentine and amphibole minerals *Fiber glass (Table 2–1) are indistinguishable by XRD Gypsum (CaSO4 · 2H2O) techniques unless special sample preparation Vermiculite (micas) techniques and instrumentation are used,9 *Perlite the presence of nonasbestiform serpentines Clays (kaolin) and amphiboles in a sample will pose severe *Wood pulp interference problems in the identification *Paper fibers (talc, clay, carbonate fillers) and quantitative analysis of their Calcium silicates (synthetic) asbestiform analogs. Opaques (chromite, magnetite inclusions The use of XRD for identification and in serpentine) quantitation of asbestiform minerals in bulk Hematite (inclusions in ‘‘amosite’’) samples may also be limited by the presence Magnesite of other interfering materials in the sample. *Diatomaceous earth For naturally occurring materials the com- B. Spray finishes or paints monly associated asbestos-related mineral Bassanite interferences can usually be anticipated. Carbonate minerals (calcite, dolomite, However, for fabricated materials the nature vaterite) of the interferences may vary greatly (Table Talc 2–3) and present more serious problems in Tremolite identification and quantitation.10 Potential Anthophyllite interferences are summarized in Table 2–4 Serpentine (including chrysotile) and include the following: Amosite ˚ • Chlorite has major peaks at 7.19 A and 3.58 Crocidolite ˚ A That interfere with both the primary *Mineral wool (7.36 A˚ ) and secondary (3.66 A˚ ) peaks for *Rock wool chrysotile. Resolution of the primary peak *Slag wool to give good quantitative results may be *Fiber glass possible when a step-scanning mode of op- Clays (kaolin) eration is employed. Micas • Halloysite has a peak at 3.63 A˚ that inter- Chlorite ˚ feres with the secondary (3.66 A) peak for Gypsum (CaSO4 · 2H2O) chrysotile. Quartz • Kaolinite has a major peak at 7.15 A˚ that *Organic binders and thickeners may interfere with the primary peak of Hyrdomagnesite chrysotile at 7.36 A˚ when present at con- Wollastonite centrations of >10 percent. However, the Opaques (chromite, magnetite inclusions secondary chrysotile peak at 3.66 A˚ may be in serpentine) used for quantitation. Hematite (inclusions in ‘‘amosite’’)

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*Amorphous materialsllcontribute only orthorhombic anthophyllite separated by to overall scattered radiation and increased less than 0.2 A˚ . 12 background radiation. 2.3.2 Matrix Effects TABLE 2–4—INTERFERENCES IN XRD ANALYSIS If a copper X-ray source is used, the pres- ASBESTIFORM MINERALS ence of iron at high concentrations in a sample will result in significant X-ray fluores- Primary cence, leading to loss of peak intensity along diagnostic with increased background intensity and an Asbestiform min- peaks Interference overall decrease in sensitivity. This situa- eral (approxi- tion may be corrected by choosing an X-ray mate d- spacings, source other than copper; however, this is in A˚ ) often accompanied both by loss of intensity and by decreased resolution of closely spaced Serpentine reflections. Alternatively, use of a diffracted Chrysotile 7.4 Nonasbestiform serpentines beam monochromator will reduce back- (antigorite, lizardite) Chlorite ground fluorescent raditation, enabling Kaolinite weaker diffraction peaks to be detected. Gypsum X-ray absorption by the sample matrix will 3.7 Chlorite result in overall attenuation of the dif- Halloysite fracted beam and may seriously interfere Cellulose with quantitative analysis. Absorption ef- Amphibole fects may be minimized by using sufficiently ‘‘Amosite’’ 3.1 Nonasbestiform amphiboles 5,13,14 Anthophyllite " (cummingtonite-grunerite, ‘‘thin’’ samples for analysis. However, Crocidolite anthophyllite, riebeckite, unless absorption effects are known to be the Tremolite tremolite) same for both samples and standards, appro- Mutual interferences priate corrections should be made by ref- Carbonates erencing diagnostic peak areas to an internal Talc standard 7,8 or filter substrate (Ag) peak. 5,6 8.3 Mutual interferences 2.3.3 Particle Size Dependence • Carbonates may also interfere with quantitative analysis of the amphibole asbestos Because the intensity of diffracted X-radi- minerals, amosite, anthophyllite, crocid- ation is particle-size dependent, it is essen- olite, and tremolite. Calcium carbonate tial for accurate quantitative analysis that ˚ both sample and standard reference mate- (CaCO3) has a peak at 3.035 A that overlaps major amphibole peaks at approximately rials have similar particle size distributions. 3.1 A˚ when present in concentrations of >5 The optimum particle size range for quan- percent. Removal of carbonates with a di- titative analysis of asbestos by XRD has μ 15 lute acid wash is possible; however, if been reported to be 1 to 10 m. Com- present, chrysotile may be partially dis- parability of sample and standard reference solved by this treatment.11 material particle size distributions should be • A major talc peak at 3.12 A˚ interferes with verified by optical microscopy (or another the primary tremolite peak at this same suitable method) prior to analysis. position and with secondary peaks of cro- 2.3.4 Preferred Orientation Effects cidolite (3.10 A˚ ), amosite (3.06 A˚ ), and anthophyllite (3.05 A˚ ). In the presence of Preferred orientation of asbestiform min- talc, the major diagnostic peak at approxi- erals during sample preparation often poses mately 8.3 A˚ should be used for quantita- a serious problem in quantitative analysis by tion of these asbestiform minerals. XRD. A number of techniques have been de- The problem of intraspecies and matrix veloped for reducing preferred orientation ef- interferences is further aggravated by the fects in ‘‘thick layer’’ samples. 7,8,15 However, variability of the silicate mineral powder for ‘‘thin’’ samples on membrane filters, the diffraction patterns themselves, which often preferred orientation effects seem to be both makes definitive identification of the asbes- reproducible and favorable to enhancement tos minerals by comparison with standard of the principal diagnostic reflections of as- reference diffraction patterns difficult. This bestos minerals, actually increasing the variability results from alterations in the overall sensitivity of the method. 12,14 (Fur- crystal lattice associated with differences in ther investigation into preferred orientation isomorphous substitution and degree of crys- effects in both thin layer and bulk samples is tallinity. This is especially true for the required.) amphiboles. These minerals exhibit a wide 2.3.5 Lack of Suitably Characterized variety of very similar chemical composi- Standard Materials tions, with the result being that their diffraction patterns are chracterized by having The problem of obtaining and character- major (110) reflections of the monoclinic izing suitable reference materials for asbes- amphiboles and (210) reflections of the tos analysis is clearly recognized. NIOSH has

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recently directed a major research effort to- 2.5.2 Sample Analysis ward the preparation and characterization of analytical reference materials, including as- Sample analysis requirements include an bestos standards; 16,17 however, these are not X-ray diffraction unit, equipped with: available in large quantities for routine • Constant Potential Generator; Voltage and analysis. mA Stabilizers In addition, the problem of ensuring the • Automated Diffractometer with Step-Scanning comparability of standard reference and Mode sample materials, particularly regarding • Copper Target X-Ray Tube: High intensity, crystallite size, particle size distribution, fine focus, preferably. and degree of crystallinity, has yet to be • X-Ray Pulse Height Selector adequately addressed. For example, Langer • X-Ray Detector (with high voltage power 18 et al. have observed that in insulating mat- supply): Scintillation or proportional rices, chrysotile tends to break open into counter. bundles more frequently than amphiboles. • Focusing Graphite Crystal Monochromator; or This results in a line-broadening effect with Nickel Filter (if copper source is used, and a resultant decrease in sensitivity. Unless iron fluorescence is not a serious problem). this effect is the same for both standard and • sample materials, the amount of chrysotile Data Output Accessories: in the sample will be underestimated by • Strip Chart Recorder XRD analysis. To minimize this problem, it • Decade Scaler/Timer is recommended that standardized matrix re- • Digital Printer duction procedures be used for both sample • Sample Spinner (optional). and standard materials. • Instrument Calibration Reference Specimen: a-quartz reference crystal (Arkansas 2.4 Precision and Accuracy quartz standard, #180–147–00, Philips Elec- Precision of the method has not been de- tronics Instruments, Inc., 85 McKee Drive, termined. Mahwah, NJ 07430) or equivalent. Accuracy of the method has not been determined. 2.6 Reagents 2.5 Apparatus 2.6.1 Standard Reference Materials 2.5.1 Sample Preparation The reference materials listed below are intended to serve as a guide. Every attempt Sample preparation apparatus require- should be made to acquire pure reference ments will depend upon the sample type materials that are comparable to sample ma- under consideration and the kind of XRD terials being analyzed. analysis to be performed. • Chrysotile: UICC Canadian, or NIEHS • Mortar and Pestle: Agate or porcelain. • Razor Blades Plastibest. (UICC reference materials • Sample Mill: SPEX, Inc., freezer mill or available from: UICC, MRC Pneumo- equivalent. coniosis Unit, Llandough Hospital, • Bulk Sample Holders Penarth, Glamorgan, CF61XW, UK). • Silver Membrane Filters: 25-mm diameter, • Crocidolite: UICC 0.45-μm pore size. Selas Corp. of America, • Amosite: UICC Flotronics Div., 1957 Pioneer Road, Hun- • Anthophyllite: UICC tington Valley, PA 19006. • Tremolite Asbestos: Wards Natural Science • Microscope Slides Establishment, Rochester, N.Y.; Cyprus • Vacuum Filtration Apparatus: Gelman No. Research Standard, Cyprus Research, 2435 1107 or equivalent, and side-arm vacuum Military Ave., Los Angeles, CA 90064 flask. (washed with dilute HCl to remove small • Microbalance amount of calcite impurity); India • Ultrasonic Bath or Probe: Model W140, tremolite, Rajasthan State, India. Ultrasonics, Inc., operated at a power den- • Actinolite Asbestos sity of approximately 0.1 W/mL, or equivalent. 2.6.2 Adhesive • Volumetric Flasks: 1–L volume. • Assorted Pipettes Tape, petroleum jelly, etc. (for attaching • Pipette Bulb silver membrane filters to sample holders). • Nonserrated Forceps • Polyethylene Wash Bottle 2.6.3 Surfactant • Pyrex Beakers: 50-mL volume. 1 percent aerosol OT aqueous solution or • Desiccator equivalent. • Filter Storage Cassettes • Magnetic Stirring Plate and Bars 2.6.4 Isopropanol • Porcelain Crucibles • Muffle Furnace or Low Temperature Asher ACS Reagent Grade.

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2.7 Procedure ples may be reduced by cutting with a razor blade in a mortar, or by grinding in a suit- 2.7.1 Sampling able mill (e.g., a microhammer mill or equiv- Samples for analysis of asbestos content alent). When using a mortar for grinding or shall be collected as specified in EPA Guid- cutting, the sample should be moistened ance Document #C0090, Asbestos-Containing with ethanol, or some other suitable wetting Materials in School Buildings.10 agent, to minimize exposures. For accurate, reproducible quantitative 2.7.2 Analysis analysis, the particle size of both sample and standard materials should be reduced to ∼10 All samples must be analyzed initially for μm (see Section 2.3.3). Dry ball milling at liq- asbestos content by PLM. XRD should be uid nitrogen temperatures (e.g., Spex Freezer used as an auxiliary method when a second, Mill, or equivalent) for a maximum time of independent analysis is requested. 10 min. is recommended to obtain satisfac- NOTE: Asbestos is a toxic substance. All tory particle size distributions while pro- handling of dry materials should be per- tecting the integrity of the crystal lattice. 5 formed in an operating fume hood. Bulk samples of very large particle size may require grinding in two stages for full matrix 2.7.2.1 Sample Preparation reduction to <10 μm. 8,16 The method of sample preparation required Final particle size distributions should al- for XRD analysis will depend on: (1) The con- ways be verified by optical microscopy or an- dition of the sample received (sample size, other suitable method. homogeneity, particle size distribution, and 2.7.2.1.2 Low temperature ashing—For ma- overall composition as determined by PLM); terials shown by PLM to contain large and (2) the type of XRD analysis to be per- amounts of gypsum, cellulosic, or other or- formed (qualitative, quantitative, thin layer ganic materials, it may be desirable to ash or bulk). the samples prior to analysis to reduce back- Bulk materials are usually received as ground radiation or matrix interference. inhomogeneous mixtures of complex com- Since chrysotile undergoes dehydroxylation position with very wide particle size dis- at temperatures between 550 °C and 650 °C, tributions. Preparation of a homogeneous, with subsequent transformation to 23,24 representative sample from asbestos-con- forsterite, ashing temperatures should be ° taining materials is particularly difficult be- kept below 500 C. Use of a low temperature cause the fibrous nature of the asbestos min- asher is recommended. In all cases, calibra- erals inhibits mechanical mixing and stir- tion of the oven is essential to ensure that a ° ring, and because milling procedures may maximum ashing temperature of 500 C is not cause adverse lattice alterations. exceeded. A discussion of specific matrix reduction 2.7.2.1.3 Acid leaching—Because of the in- procedures is given below. Complete methods terference caused by gypsum and some car- of sample preparation are detailed in Sec- bonates in the detection of asbestiform minerals by XRD (see Section 2.3.1), it may be tions 2.7.2.2 and 2.7.2.3. necessary to remove these interferents by a NOTE: All samples should be examined mi- simple acid leaching procedure prior to anal- croscopically before and after each matrix ysis (see Section 1.7.2.2). reduction step to monitor changes in sample particle size, composition, and crystallinity, 2.7.2.2 Qualitative Analysis and to ensure sample representativeness and 2.7.2.2.1 Initial screening of bulk material— homogeneity for analysis. Qualitative analysis should be performed on 2.7.2.1.1 Milling— Mechanical milling of a representative, homogeneous portion of the asbestos materials has been shown to de- sample with a minimum of sample treat- crease fiber crystallinity, with a resultant ment. decrease in diffraction intensity of the speci- 1. Grind and mix the sample with a mortar men; the degree of lattice alteration is re- and pestle (or equivalent method, see Sec- lated to the duration and type of milling tion 2.7.2.1.1.) to a final particle size suffi- process. 19,22 Therefore, all milling times ciently small (∼100 μm) to allow adequate should be kept to a minimum. packing into the sample holder. For qualitative analysis, particle size is not 2. Pack the sample into a standard bulk usually of critical importance and initial sample holder. Care should be taken to en- characterization of the material with a min- sure that a representative portion of the imum of matrix reduction is often desirable milled sample is selected for analysis. Par- to document the composition of the sample ticular care should be taken to avoid pos- as received. Bulk samples of very large par- sible size segregation of the sample. (Note: ticle size (>2–3 mm) should be comminuted Use of a back-packing method 25 of bulk sam- to ∼100 μm. A mortar and pestle can some- ple preparation may reduce preferred ori- times be used in size reduction of soft or entation effects.) loosely bound materials though this may 3. Mount the sample on the diffractometer cause matting of some samples. Such sam- and scan over the diagnostic peak regions for

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the serpentine (∼67.4 A˚ ) and amphibole (8.2– 2. Dry at 100 °C for 2 hr; cool in a desic- 8.5 A˚ ) minerals (see Table 2–2). The X-ray dif- cator. fraction equipment should be optimized for 3. Weigh accurately to the nearest 0.01 mg. intensity. A slow scanning speed of 1° 2q/min 4. Samples shown by PLM to contain large is recommended for adequate resolution. Use amounts of cellulosic or other organic mate- of a sample spinner is recommended. rials, gypsum, or carbonates, should be sub- 4. Submit all samples that exhibit diffrac- mitted to appropriate matrix reduction pro- tion peaks in the diagnostic regions for cedures described in Sections 2.7.2.1.2 and asbestiform minerals to a full qualitative 2.7.2.1.3. After ashing and/or acid treatment, XRD scan (5°–60° 2q; 1°2q/min) to verify initial repeat the drying and weighing procedures peak assignments and to identify potential described above, and determine the percent matrix interferences when subsequent quan- weight loss; L. titative analysis is to be performed. 5. Quantitatively transfer an accurately 5. Compare the sample XRD pattern with weighed amount (50–100 mg) of the sample to standard reference powder diffraction pat- a 1–L volumetric flask with approximately terns (i.e., JCPDS powder diffraction data 3 200 mL isopropanol to which 3 to 4 drops of or those of other well-characterized ref- surfactant have been added. erence materials). Principal lattice spacings 6. Ultrasonicate for 10 min at a power den- of asbestiform minerals are given in Table 2– sity of approximately 0.1 W/mL, to disperse 2; common constituents of bulk insulation the sample material. and wall materials are listed in Table 2–3. 7. Dilute to volume with isopropanol. 2.7.2.2.2 Detection of minor or trace constitu- 8. Place flask on a magnetic stirring plate. ents— Routine screening of bulk materials Stir. 9. Place a silver membrane filter on the fil- by XRD may fail to detect small concentra- tration apparatus, apply a vacuum, and at- tions (<5 percent) of asbestos. The limits of tach the reservoir. Release the vacuum and detection will, in general, be improved if ma- add several milliliters of isopropanol to the trix absorption effects are minimized, and if reservoir. Vigorously hand shake the asbes- the sample particle size is reduced to the op- tos suspension and immediately withdraw an timal 1 to 10 μm range, provided that the aliquot from the center of the suspension so crystal lattice is not degraded in the milling that total sample weight, W , on the filter process. Therefore, in those instances where T will be approximately 1 mg. Do not adjust confirmation of the presence of an the volume in the pipet by expelling part of asbestiform mineral at very low levels is re- the suspension; if more than the desired ali- quired, or where a negative result from ini- quot is withdrawn, discard the aliquot and tial screening of the bulk material by XRD resume the procedure with a clean pipet. (see Section 2.7.2.2.1) is in conflict with pre- Transfer the aliquot to the reservoir. Filter vious PLM results, it may be desirable to rapidly under vacuum. Do not wash the res- prepare the sample as described for quan- ervoir walls. Leave the filter apparatus titative analysis (see Section 2.7.2.3) and under vacuum until dry. Remove the res- step-scan over appropriate 2q ranges of se- ervoir, release the vacuum, and remove the lected diagnostic peaks (Table 2–2). Accurate filter with forceps. (Note: Water-soluble ma- transfer of the sample to the silver mem- trix interferences such as gypsum may be re- brane filter is not necessary unless subse- moved at this time by careful washing of the quent quantitative analysis is to be per- filtrate with distilled water. Extreme care formed. should be taken not to disturb the sample.) 2.7.2.3 Quantitative Analysis 10. Attach the filter to a flat holder with a suitable adhesive and place on the diffrac- The proposed method for quantitation of tometer. Use of a sample spinner is rec- asbestos in bulk samples is a modification of ommended. the NIOSH-recommended thin-layer method 11. For each asbestos mineral to be for chrysotile in air. 5 A thick-layer or bulk quantitated select a reflection (or reflec- method involving pelletizing the sample may tions) that has been shown to be free from be used for semiquantitative analysis; 7,8 interferences by prior PLM or qualitative however, this method requires the addition XRD analysis and that can be used unambig- of an internal standard, use of a specially uously as an index of the amount of material fabricated sample press, and relatively large present in the sample (see Table 2–2). amounts of standard reference materials. Ad- 12. Analyze the selected diagnostic reflec- ditional research is required to evaluate the tion(s) by step scanning in increments of comparability of thin- and thick-layer meth- 0.02° 2q for an appropriate fixed time and in- ods for quantitative asbestos analysis. tegrating the counts. (A fixed count scan For quantitative analysis by thin-layer may be used alternatively; however, the methods, the following procedure is rec- method chosen should be used consistently ommended: for all samples and standards.) An appro- 1. Mill and size all or a substantial rep- priate scanning interval should be selected resentative portion of the sample as outlined for each peak, and background corrections in Section 2.7.2.1.1. made. For a fixed time scan, measure the

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background on each side of the peak for one- the aliquot to the reservoir. Keep the tip of half the peak-scanning time. The net inten- the pipet near the surface of the isopropanol. sity, Ia, is the difference between the peak in- Filter rapidly under vacuum. Do not wash tegrated count and the total background the sides of the reservoir. Leave the vacuum count. on for a time sufficient to dry the filter. Re- 13. Determine the net count, IAg, of the fil- lease the vacuum and remove the filter with ter 2.36 A˚ silver peak following the procedure forceps. in step 12. Remove the filter from the holder, reverse it, and reattach it to the holder. De- 2.8.2 Analysis of Calibration Standards termine the net count for the unattenuated 1. Mount each filter on a flat holder. Per- silver peak, IA˚ g. Scan times may be less for form step scans on selected diagnostic reflec- measurement of silver peaks than for sample tions of the standards and reference speci- peaks; however, they should be constant men using the procedure outlined in Section throughout the analysis. 2.7.2.3, step 12, and the same conditions as 14. Normalize all raw, net intensities (to those used for the samples. correct for instrument instabilities) by ref- 2. Determine the normalized intensity for erencing them to an external standard (e.g., each peak measured, Iˆ˚ as outlined in Sec- the 3.34 A˚ peak of an a-quartz reference crys- std, tion 2.7.2.3, step 14. tal). After each unknown is scanned, determine the net count, Ir˚, of the reference speci- 2.9 Calculations men following the procedure in step 12. De- termine the normalized intensities by divid- For each asbestos reference material, cal- ing the peak intensities by Ir˚: culate the exact weight deposited on each standard filter from the concentrations of the standard suspensions and aliquot volumes. Record the weight, w, of each standard. Prepare a calibration curve by regress- ˆ ing I2s˚td on w. Poor reproducibility (±15 percent RSD) at any given level indicates prob- 2.8 Calibration lems in the sample preparation technique, and a need for new standards. The data 2.8.1 Preparation of Calibration Standards should fit a straight line equation. 1. Mill and size standard asbestos materials Determine the slope, m, of the calibration according to the procedure outlined in Sec- curve in counts/microgram. The intercept, b, ˆ tion 2.7.2.1.1. Equivalent, standardized matrix of the line with the Is˚td axis should be ap- reduction and sizing techniques should be used proximately zero. A large negative intercept for both standard and sample materials. indicates an error in determining the back- 2. Dry at 100 °C for 2 hr; cool in a desic- ground. This may arise from incorrectly cator. measuring the baseline or from interference 3. Prepare two suspensions of each standby another phase at the angle of background ard in isopropanol by weighing approxi- measurement. A large positive intercept in- mately 10 and 50 mg of the dry material to dicates an error in determining the baseline the nearest 0.01 mg. Quantitatively transfer or that an impurity is included in the meas- each to a 1–L volumetric flask with approxi- ured peak. ˆ mately 200 mL isopropanol to which a few Using the normalized intensity, IAg, for the drops of surfactant have been added. attenuated silver peak of a sample, and the 4. Ultrasonicate for 10 min at a power den- corresponding normalized intensity from the ˆ sity of approximately 0.1 W/mL, to disperse unattenuated silver peak, IA˚ g, of the sample the asbestos material. filter, calculate the transmittance, T, for 5. Dilute to volume with isopropanol. each sample as follows: 26,27 6. Place the flask on a magnetic stirring plate. Stir. 7. Prepare, in triplicate, a series of at least five standard filters to cover the desired analytical range, using appropriate aliquots of the 10 and 50 mg/L suspensions and the following procedure. Mount a silver membrane filter on the filtration apparatus. Place a few milliliters of isopropanol in the reservoir. Vigorously hand shake the asbestos suspension and im- Determine the correction factor, f(T), for mediately withdraw an aliquot from the cen- each sample according to the formula: ter of the suspension. Do not adjust the vol- -R (ln T) ume in the pipet by expelling part of the sus- f (T) = llll pension; if more than the desired aliquot is l-TR withdrawn, discard the aliquot and resume the procedure with a clean pipet. Transfer where

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7. H. Dunn and J. H. Stewart, Jr., Quan- sin Q Ag titative determination of chrysotile in build- R= llll ing materials, The Microscope, 29(1), 1981. sin Qa 8. M. Taylor, Methods for the quantitative

qAg=angular position of the measured silver determination of asbestos and quartz in bulk peak (from Bragg’s Law), and samples using X-ray diffraction, The Analyst,

qa=angular position of the diagnostic asbes- 103(1231):1009–1020, 1978. tos peak. 9. L. Birks, M. Fatemi, J. V. Gilfrich, and

Calculate the weight, Wa, in micrograms, E. T. Johnson, Quantitative Analysis of Air- of the asbestos material analyzed for in each borne Asbestos by X-ray Diffraction, Naval Re- sample, using the appropriate calibration search Laboratory Report 7879, Naval Re- data and absorption corrections: search Laboratory, Washington, DC, 1975. 10. U.S. Environmental Protection Agency, Asbestos-Containing Materials in School Build- ings: A Guidance Document, Parts 1 and 2, EPA/OPPT No. C00090, March 1979. 11. J. B. Krause and W. H. Ashton, Misidentification of asbestos in talc, pp. 339– 353, in: Proceedings of Workshop on Asbestos: Definitions and Measurement Methods (NBS

Calculate the percent composition, Pa, of Special Publication 506), C. C. Gravatt, P. D. each asbestos mineral analyzed for in the LaFleur, and K. F. Heinrich (eds.), Wash- parent material, from the total sample ington, DC: National Measurement Labora- weight, WT, on the filter: tory, National Bureau of Standards, 1977 (issued 1978). W (1-.01L) a 12. H. D. Stanley, The detection and identi- = llll Pa — x 100 fication of asbestos and asbesti-form min- WT erals in talc, pp. 325–337, in Proceedings of where Workshop on Asbestos: Definitions and Meas- urement Methods (NBS Special Publication Pa=percent asbestos mineral in parent material; 506), C. C. Gravatt, P. D. LaFleur, and K. F. Heinrich (eds.), Washington, DC, National W =mass of asbestos mineral on filter, in μg; a Measurement Laboratory, National Bureau W =total sample weight on filter, in μg; T of Standards, 1977 (issued 1978). L=percent weight loss of parent material on 13. A. L. Rickards, Estimation of trace ashing and/or acid treatment (see Section amounts of chrysotile asbestos by X-ray dif- 2.7.2.3). fraction, Anal. Chem., 44(11):1872–3, 1972. 2.10 References 14. P. M. Cook, P. L. Smith, and D. G. Wil- son, Amphibole fiber concentration and de- 1. H. P. Klug and L. E. Alexander, X-ray termination for a series of community air Diffraction Procedures for Polycrystalline and samples: use of X-ray diffraction to supple- Amorphous Materials, 2nd ed., New York: ment electron microscope analysis, in: Elec- John Wiley and Sons, 1979. tron Microscopy and X-ray Applications to En- 2. L. V. Azaroff and M. J. Buerger, The vironmental and Occupation Health Analysis, Powder Method of X-ray Crystallography, New P. A. Russell and A. E. Hutchings (eds.), Ann York: McGraw-Hill, 1958. Arbor: Ann Arbor Science Publications, 1977. 3. JCPDS-International Center for Diffraction 15. A. N. Rohl and A. M. Langer, Identifica- Data Powder Diffraction File, U.S. Depart- tion and quantitation of asbestos in talc, En- ment of Commerce, National Bureau of viron. Health Perspectives, 9:95–109, 1974. Standards, and Joint Committee on Powder 16. J. L. Graf, P. K. Ase, and R. G. Draftz, Diffraction Studies, Swarthmore, PA. Preparation and Characterization of Analytical 4. W. J. Campbell, C. W. Huggins, and A. G. Reference Minerals, DHEW (NIOSH) Publica- Wylie, Chemical and Physical Characterization tion No. 79–139, June 1979. of Amosite, Chrysotile, Crocidolite, and Non- 17. J. C. Haartz, B. A. Lange, R. G. Draftz, fibrous Tremolite for National Institute of Envi- and R. F. Scholl, Selection and characteriza- ronmental Health Sciences Oral Ingestion Stud- tion of fibrous and nonfibrous amphiboles for ies, U.S. Bureau of Mines Report of Inves- analytical methods development, pp. 295–312, tigation RI8452, 1980. in: Proceedings of Workshop on Asbestos: Defi- 5. B. A. Lange and J. C. Haartz, Determina- nitions and Measurement Methods (NBS Spe- tion of microgram quantities of asbestos by cial Publication 506), C. C. Gravatt, P. D. La- X-ray diffraction: Chrysotile in thin dust Fleur, and K. F. Heinrich (eds.), Washington, layers of matrix material, Anal. Chem., DC: National Measurement Laboratory, Na- 51(4):520–525, 1979. tional Bureau of Standards, 1977 (issued 6. NIOSH Manual of Analytical Methods, 1978). Volume 5, U.S. Dept. HEW, August 1979, pp. 18. Personal communication, A. M. Langer, 309–1 to 309–9. Environmental Sciences Laboratory, Mount

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Sinai School of Medicine of the City Univer- has exempted from the requirements of sity of New York, New York, New York. this subpart under § 763.123, you must 19. A. M. Langer, M. S. Wolff, A. N. Rohl, follow the requirements of this subpart and I. J. Selikoff, Variation of properties of to protect your employees from occu- chrysotile asbestos subjected to milling, J. Toxicol. and Environ. Health, 4:173–188, 1978. pational exposure to asbestos. 20. A. M. Langer, A. D. Mackler, and F. D. Pooley, Electron microscopical investigation § 763.122 What does this subpart re- of asbestos fibers, Environ. Health Perspect., quire me to do? 9:63–80, 1974. If you are a State or local govern- 21. E. Occella and G. Maddalon, X-ray dif- ment employer whose employees per- fraction characteristics of some types of as- form: bestos in relation to different techniques of comminution, Med. Lavoro, 54(10):628–636, (a) Construction activities identified 1963. in 29 CFR 1926.1101(a), you must: 22. K. R. Spurny, W. Sto¨ ber, H. Opiela, and (1) Comply with the OSHA standards G. Weiss, On the problem of milling and ul- in 29 CFR 1926.1101. trasonic treatment of asbestos and glass fi- (2) Submit notifications required for bers in biological and analytical applica- alternative control methods to the Di- tions, Am. Ind. Hyg. Assoc. J., 41:198–203, 1980. rector, National Program Chemicals 23. L. G. Berry and B. Mason, Mineralogy, San Francisco: W. H. Greeman & Co., 1959. Division (7404), Office of Pollution Pre- 24. J. P. Schelz, The detection of chrysotile vention and Toxics, Environmental asbestos at low levels in talc by differential Protection Agency, 1200 Pennsylvania thermal analysis, Thermochimica Acta, 8:197– Ave., NW., Washington, DC 20460. 204, 1974. (b) Custodial activities not associ- 25. Reference 1, pp. 372–374. ated with the construction activities 26. J. Leroux, Staub-Reinhalt Luft, 29:26 identified in 29 CFR 1926.1101(a), you (English), 1969. 27. J. A. Leroux, B. C. Davey, and A. must comply with the OSHA standards Paillard, Am. Ind. Hyg. Assoc. J., 34:409, 1973. in 29 CFR 1910.1001. (c) Repair, cleaning, or replacement [47 FR 23369, May 27, 1982; 47 FR 38535, Sept. of asbestos-containing clutch plates 1, 1982; Redesignated at 60 FR 31922, June 19, 1995] and brake pads, shoes, and linings, or removal of asbestos-containing residue from brake drums or clutch housings, Subpart F [Reserved] you must comply with the OSHA standards in 29 CFR 1910.1001. Subpart G—Asbestos Worker Protection § 763.123 May a State implement its own asbestos worker protection plan? SOURCE: 65 FR 69216, Nov. 15, 2000, unless otherwise noted. This section describes the process under which a State may be exempted § 763.120 What is the purpose of this from the requirements of this subpart. subpart? (a) States seeking an exemption. If your This subpart protects certain State State wishes to implement its own as- and local government employees who bestos worker protection plan, rather are not protected by the Asbestos than complying with the requirements Standards of the Occupational Safety of this subpart, your State must apply and Health Administration (OSHA). for and receive an exemption from This subpart applies the OSHA Asbes- EPA. tos Standards in 29 CFR 1910.1001 and 29 (1) What must my State do to apply for CFR 1926.1101 to these employees. an exemption? To apply for an exemption from the requirements of this sub- § 763.121 Does this subpart apply to part, your State must send to the Di- me? rector of EPA’s Office of Pollution Pre- If you are a State or local govern- vention and Toxics (OPPT) a copy of ment employer and you are not subject its asbestos worker protection regula- to a State asbestos standard that tions and a detailed explanation of how OSHA has approved under section 18 of your State’s asbestos worker protec- the Occupational Safety and Health tion plan meets the requirements of Act or a State asbestos plan that EPA TSCA section 18 (15 U.S.C. 2617).

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(2) What action will EPA take on my State’s updated asbestos worker pro- State’s application for an exemption? tection plan meets the requirements of EPA will review your State’s applica- TSCA section 18. tion and make a preliminary deter- (i) If EPA determines that the up- mination whether your State’s asbes- dated State plan does meet the require- tos worker protection plan meets the ments of TSCA section 18, EPA will requirements of TSCA section 18. issue your State an amended exemp- (i) If EPA’s preliminary determination. tion is that your State’s plan does (ii) If EPA determines that the up- meet the requirements of TSCA section dated State plan does not meet the re- 18, EPA will initiate a rulemaking, in- quirements of TSCA section 18, EPA cluding an opportunity for public com- will notify your State in writing and ment, to exempt your State from the will give your State a reasonable op- requirements of this subpart. After portunity to respond to that deter- considering any comments, EPA will mination. issue a final rule granting or denying (iii) If EPA does not grant your State the exemption. an amended exemption, or if your (ii) If EPA’s preliminary determination is that the State plan does not State does not submit a timely request meet the requirements of TSCA section for amended exemption, then the State 18, EPA will notify your State in writ- and local government employers in ing and will give your State a reason- your State are subject to the require- able opportunity to respond to that de- ments of this subpart. termination. (iii) If EPA does not grant your State Subpart H [Reserved] an exemption, then the State and local government employers in your State Subpart I—Prohibition of the Man- are subject to the requirements of this ufacture, Importation, Proc- subpart. (b) States that have been granted an ex- essing, and Distribution in emption. If EPA has exempted your Commerce of Certain Asbes- State from the requirements of this tos-Containing Products; La- subpart, your State must update its as- beling Requirements bestos worker protection regulations as necessary to implement changes to SOURCE: 54 FR 29507, July 12, 1989, unless meet the requirements of this subpart, otherwise noted. and must apply to EPA for an amendment to its exemption. § 763.160 Scope. (1) What must my State do to apply for This subpart prohibits the manufac- an amendment to its exemption? To apply ture, importation, processing, and dis- for an amendment to its exemption, tribution in commerce of the asbestos- your State must send to the Director containing products identified and at of OPPT a copy of its updated asbestos the dates indicated in §§ 763.165, 763.167, worker protection regulations and a and 763.169. This subpart requires that detailed explanation of how your products subject to this rule’s bans, State’s updated asbestos worker pro- but not yet subject to a ban on dis- tection plan meets the requirements of tribution in commerce, be labeled. This TSCA section 18. Your State must sub- subpart also includes general exemp- mit its application for an amendment tions and procedures for requesting ex- within 6 months of the effective date of emptions from the provisions of this any changes to the requirements of subpart. this subpart, or within a reasonable time agreed upon by your State and § 763.163 Definitions. OPPT. (2) What action will EPA take on my For purposes of this subpart: State’s application for an amendment? Act means the Toxic Substances Con- EPA will review your State’s applica- trol Act, 15 U.S.C. 2601 et seq. tion for an amendment and make a pre- Agency means the United States En- liminary determination whether your vironmental Protection Agency.

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Asbestos means the asbestiform vari- toms territory of the United States for eties of: chrysotile (serpentine); crocid- export without any use, processing, or olite (riebeckite); amosite disposal within the customs territory (cummingtonite-grunerite); tremolite; of the United States; or (2) entering the anthophyllite; and actinolite. customs territory of the United States Asbestos-containing product means any as a component of a product during product to which asbestos is delib- normal personal or business activities erately added in any concentration or involving use of the product. which contains more than 1.0 percent Importer means anyone who imports a asbestos by weight or area. chemical substance, including a chem- Chemical substance, has the same ical substance as part of a mixture or meaning as in section 3 of the Act. article, into the customs territory of Commerce has the same meaning as in the United States. Importer includes section 3 of the Act. the person primarily liable for the pay- Commercial paper means an asbestos- ment of any duties on the merchandise containing product which is made of or an authorized agent acting on his or paper intended for use as general insu- her behalf. The term includes as appro- lation paper or muffler paper. Major priate: applications of commercial papers are (1) The consignee. insulation against fire, heat transfer, (2) The importer of record. and corrosion in circumstances that re- (3) The actual owner if an actual quire a thin, but durable, barrier. owner’s declaration and superseding Corrugated paper means an asbestos- bond has been filed in accordance with containing product made of corrugated 19 CFR 141.20. paper, which is often cemented to a flat (4) The transferee, if the right to backing, may be laminated with foils withdraw merchandise in a bonded or other materials, and has a cor- warehouse has been transferred in ac- rugated surface. Major applications of cordance with subpart C of 19 CFR part asbestos corrugated paper include: 144. thermal insulation for pipe coverings; Manufacture means to produce or block insulation; panel insulation in manufacture in the United States. elevators; insulation in appliances; and Manufacturer means a person who insulation in low-pressure steam, hot produces or manufactures in the water, and process lines. United States. Customs territory of the United States New uses of asbestos means commer- means the 50 States, Puerto Rico, and cial uses of asbestos not identified in the District of Columbia. § 763.165 the manufacture, importation Distribute in commerce has the same or processing of which would be initi- meaning as in section 3 of the Act, but ated for the first time after August 25, the term does not include actions 1989. taken with respect to an asbestos-con- Person means any natural person, taining product (to sell, resale, deliver, firm, company, corporation, joint-ven- or hold) in connection with the end use ture, partnership, sole proprietorship, of the product by persons who are users association, or any other business enti- (persons who use the product for its in- ty; any State or political subdivision tended purpose after it is manufactured thereof, or any municipality; any or processed). The term also does not interstate body and any department, include distribution by manufacturers, agency, or instrumentality of the Fed- importers, and processors, and other eral Government. persons solely for purposes of disposal Process has the same meaning as in of an asbestos-containing product. section 3 of the Act. Flooring felt means an asbestos-con- Processor has the same meaning as in taining product which is made of paper section 3 of the Act. felt intended for use as an underlayer Rollboard means an asbestos-con- for floor coverings, or to be bonded to taining product made of paper that is the underside of vinyl sheet flooring. produced in a continuous sheet, is Import means to bring into the cus- flexible, and is rolled to achieve a de- toms territory of the United States, ex- sired thickness. Asbestos rollboard cept for: (1) Shipment through the cus- consists of two sheets of asbestos paper

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laminated together. Major applications § 763.167 Processing prohibitions. of this product include: office parti- (a) After August 27, 1990, no person tioning; garage paneling; linings for shall process for any use, either in the stoves and electric switch boxes; and United States or for export, any of the fire-proofing agent for security boxes, asbestos-containing products listed at safes, and files. § 763.165(a). Specialty paper means an asbestos- (b) After August 26, 1996, no person containing product that is made of shall process for any use, either in the paper intended for use as filters for United States or for export, any of the beverages or other fluids or as paper asbestos-containing products listed at fill for cooling towers. Cooling tower § 763.165(b). fill consists of asbestos paper that is [59 FR 33209, June 28, 1994] used as a cooling agent for liquids from industrial processes and air condi- § 763.169 Distribution in commerce tioning systems. prohibitions. State has the same meaning as in sec- (a) After August 25, 1992, no person tion 3 of the Act. shall distribute in commerce, either for Stock-on-hand means the products use in the United States or for export, which are in the possession, direction, any of the asbestos-containing prod- or control of a person and are intended ucts listed at § 763.165(a). for distribution in commerce. (b) After August 25, 1997, no person shall distribute in commerce, either for United States has the same meaning use in the United States or for export, as in section 3 of the Act. any of the asbestos-containing prod- [59 FR 33208, June 28, 1994] ucts listed at § 763.165(b). (c) A manufacturer, importer, proc- § 763.165 Manufacture and importation essor, or any other person who is sub- prohibitions. ject to a ban on distribution in com- (a) After August 27, 1990, no person merce in paragraph (a) or (b) of this shall manufacture or import the fol- section must, within 6 months of the effective date of the ban of a specific lowing asbestos-containing products, asbestos-containing product from dis- either for use in the United States or tribution in commerce, dispose of all for export: flooring felt and new uses of their remaining stock-on-hand of that asbestos. product, by means that are in compli- (b) After August 26, 1996, no person ance with applicable local, State, and shall manufacture or import the fol- Federal restrictions which are current lowing asbestos-containing products, at that time. either for use in the United States or for export: commercial paper, cor- [59 FR 33209, June 28, 1994] rugated paper, rollboard, and specialty § 763.171 Labeling requirements. paper. (a) After August 27, 1990, manufactur- (c) The import prohibitions of this ers, importers, and processors of all as- subpart do not prohibit: bestos-containing products that are (1) The import into the customs ter- identified in § 763.165(a) shall label the ritory of the United States of products products as specified in this subpart at imported solely for shipment outside the time of manufacture, import, or the customs territory of the United processing. This requirement includes States, unless further repackaging or labeling all manufacturers’, importers’, processing of the product is performed and processors’ stock-on-hand as of Au- in the United States; or gust 27, 1990. (2) Activities involving purchases or (b) After August 25, 1995, manufactur- acquisitions of small quantities of ers, importers, and processors of all as- products made outside the customs ter- bestos-containing products that are ritory of the United States for personal identified in § 763.165(b), shall label the use in the United States. products as specified in this subpart at the time of manufacture, import, or [59 FR 33209, June 28, 1994] processing. This requirement includes

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labeling all manufacturers’, importers’, NOTICE and processors’ stock-on-hand as of Au- This product contains ASBESTOS. The U.S. gust 25, 1995. Environmental Protection Agency has (c) The label shall be placed directly banned the distribution in U.S. commerce of on the visible exterior of the wrappings this product under section 6 of the Toxic Substances Control Act (15 U.S.C. 2605) as of and packaging in which the product is (insert effective date of ban on distribution placed for sale, shipment, or storage. If in commerce). Distribution of this product in the product has more than one layer of commerce after this date and intentionally external wrapping or packaging, the removing or tampering with this label are label must be attached to the inner- violations of Federal law. most layer adjacent to the product. If (e) No one may intentionally remove, the innermost layer of product wrap- deface, cover, or otherwise obscure or ping or packaging does not have a visi- tamper with a label or sticker that has ble exterior surface larger than 5 been applied in compliance with this square inches, either a tag meeting the section, except when the product is requirements of paragraph (d) of this used or disposed of. section must be securely attached to [59 FR 33209, June 28, 1994] the product’s innermost layer of product wrapping or packaging, or a label § 763.173 Exemptions. must be attached to the next outer (a) Persons who are subject to the layer of product packaging or wrap- prohibitions imposed by § 763.165, ping. Any products that are distributed § 763.167, or § 763.169 may file an applica- in commerce to someone other than tion for an exemption. Persons whose the end user, shipped, or stored with- exemption applications are approved out packaging or wrapping must be la- by the Agency may manufacture, im- beled or tagged directly on a visible export, process, or distribute in com- terior surface of the product as de- merce the banned product as specified scribed in paragraph (d) of this section. in the Agency’s approval of the appli- (d)(1) Labels must be either printed cation. No applicant for an exemption directly on product packaging or in the may continue the banned activity that form of a sticker or tag made of plas- is the subject of an exemption applica- tic, paper, metal, or other durable sub- tion after the effective date of the ban stances. Labels must be attached in unless the Agency has granted the exemption or the applicant receives an such a manner that they cannot be re- extension under paragraph (b)(4) or (5) moved without defacing or destroying of this section. them. Product labels shall appear as in (b) Application filing dates. (1) Appli- paragraph (d)(2) of this section and cations for products affected by the consist of block letters and numerals of prohibitions under §§ 763.165(a) and color that contrasts with the back- 763.167(a) may be submitted at any ground of the label or tag. Labels shall time and will be either granted or de- be sufficiently durable to equal or ex- nied by EPA as soon as is feasible. ceed the life, including storage and dis- (2) Applications for products affected posal, of the product packaging or by the ban under § 763.169(a) may be wrapping. The size of the label or tag submitted at any time and will be ei- must be at least 15.25 cm (6 inches) on ther granted or denied by EPA as soon each side. If the product packaging is as is feasible. too small to accommodate a label of (3) Applications for products affected this size, the label may be reduced in by the ban under §§ 763.165(b) and size proportionately to the size of the 763.167(b) may not be submitted prior product packaging or wrapping down to to February 27, 1995. Complete applica- a minimum 2.5 cm (1 inch) on each side tions received after that date, but be- if the product wrapping or packaging fore August 25, 1995, will be either has a visible exterior surface larger granted or denied by the Agency prior than 5 square inches. to the effective date of the ban for the product. Applications received after (2) Products subject to this subpart August 25, 1995, will be either granted shall be labeled in English as follows: or denied by EPA as soon as is feasible.

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(4) Applications for products affected 20460, ATTENTION: Asbestos Exemp- by the ban under § 763.169(b) may not be tion. For information regarding the submitted prior to February 26, 1996. submission of exemptions containing Complete applications received after information claimed as confidential that date, but before August 26, 1996, business information (CBI), see will be either granted or denied by the § 763.179. Agency prior to the effective date of (d) Content of application and cri- the ban for the product. Applications teria for decisionmaking. received after August 26, 1996, will be (1) Content of application. Each ap- either granted or denied by EPA as plication must contain the following: soon as is feasible. (i) Name, address, and telephone (5) The Agency will consider an appli- number of the applicant. cation for an exemption from a ban (ii) Description of the manufacturing, under § 763.169 for a product at the same import, processing, and/or distribution time the applicant submits an applica- in commerce activity for which an ex- tion for an exemption from a ban under emption is requested, including a de- § 763.165 or § 763.167 for that product. scription of the asbestos-containing EPA will grant an exemption at that product to be manufactured, imported, time from a ban under § 763.169 if the processed, or distributed in commerce. Agency determines it appropriate to do (iii) Identification of locations at so. which the exempted activity would (6) If the Agency denies an applica- take place. tion less than 30 days before the effec- (iv) Length of time requested for ex- tive date of a ban for a product, the ap- emption (maximum length of an ex- plicant can continue the activity for 30 emption is 4 years). days after receipt of the denial from (v) Estimated amount of asbestos to the Agency. be used in the activity that is the sub- (7) If the Agency fails to meet the ject of the exemption application. deadlines stated in paragraphs (b)(3) (vi) Data demonstrating the exposure and (b)(4) of this section for granting or level over the life cycle of the product denying a complete application in in- that is the subject of the application. stances in which the deadline is before (vii) Data concerning: the effective date of the ban to which (A) The extent to which non-asbestos the application applies, the applicant substitutes for the product that is the will be granted an extension of 1 year subject of the application fall signifi- from the Agency’s deadline date. Dur- cantly short in performance under nec- ing this extension period the applicant essary product standards or require- may continue the activity that is the ments, including laws or ordinances subject of the exemption application. mandating product safety standards. The Agency will either grant or deny (B) The costs of non-asbestos sub- the application during the extension stitutes relative to the costs of the as- period. The extension period will ter- bestos-containing product and, in the minate either on the date the Agency case in which the product is a compo- grants the application or 30 days after nent of another product, the effect on the applicant receives the Agency’s de- the cost of the end use product of using nial of the application. However, no ex- the substitute component. tension will be granted if the Agency is (C) The extent to which the product scheduled to grant or deny an applica- or use serves a high-valued use. tion at some date after the effective (viii) Evidence of demonstrable good date of the ban, pursuant to the dead- faith attempts by the applicant to de- lines stated in paragraphs (b)(3) and velop and use a non-asbestos substance (b)(4) of this section. or product which may be substituted (c) Where to file. All applications for the asbestos-containing product or must be submitted to the following lo- the asbestos in the product or use that cation: TSCA Docket Receipts Office is the subject to the application. (7407), Office of Pollution Prevention (ix) Evidence, in addition to that pro- and Toxics, U.S. Environmental Pro- vided in the other information required tection Agency, Rm E-G99, 1200 Penn- with the application, showing that the sylvania Ave., NW., Washington, DC continued manufacture, importation,

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processing, distribution in commerce, mine that an extension period provided and use, as applicable, of the product for in paragraph (b)(5) of this section is will not present an unreasonable risk unavailable to the applicant. of injury to human health. (h) When denying an application, the (2) Criteria for decision (existing Agency will notify the applicant by products). After considering all the in- registered mail of its decision and ra- formation provided by an applicant tionale. Whenever possible, the Agency under paragraphs (d)(1) and (e) of this will send this letter prior to the appro- section, and any other information priate ban. This letter will be consid- available to EPA, EPA will grant an ered a final Agency action for purposes exemption from the prohibitions in of judicial review. A notice announcing §§ 763.165, 763.167, or 763.169 for an appli- the Agency’s denial of the application cant’s asbestos-containing product will be published in the FEDERAL REG- only if EPA determines both of the fol- ISTER. lowing: (i) If the Agency proposes to approve (i) The applicant has made good faith an exemption, it will issue a notice in attempts to develop and use a non-as- the FEDERAL REGISTER announcing this bestos substance or product which may intent and invite public comments. If, be substituted for the asbestos-con- after considering any timely comments taining product or the asbestos in the received, the Agency approves an ex- product or use, and those attempts emption, its decision will be published have failed to produce a substitute or a in the FEDERAL REGISTER. This notice substitute that results in a product will be considered a final Agency ac- that can be economically produced. tion for purposes of judicial review. (ii) Continued manufacturing, proc- (j) The length of an exemption period essing, distribution in commerce, and will be specified by the agency when it use, as applicable, of the product will approves the exemption. To extend an not present an unreasonable risk of in- exemption period beyond the period jury to human health. stipulated by EPA, applicants must (3) Criteria for decision (new prod- submit a new application to the Agen- ucts). Requests to develop and use an cy, following the application proce- asbestos substance or product will be dures described in this section. Appli- treated as a petition pursuant to sec- cations may not be submitted prior to tion 21 of TSCA. 15 months before the expiration of the (e) The Agency reserves the right to exemption period, unless stated other- request further information from an wise in the notice granting the exemp- exemption applicant if necessary to tion. Applications received between 15 complete the Agency’s evaluation of an months and 1 year before the end of the application. exemption period will be either granted (f) Upon receipt of a complete appli- or denied by the Agency before the end cation, the Agency will issue a notice of the exemption period. Applications in the FEDERAL REGISTER announcing received after the date 1 year prior to its receipt and invite public comments the end of the exemption period will be on the merits of the application. either granted or denied by the Agency (g) If the application does not include as soon as is feasible. Applicants may all of the information required in para- not continue the activity that is the graph (d) of this section, the Agency subject of the renewal application after will return it to the applicant as in- the date of the end of the exemption complete and any resubmission of the period. application will be considered a new [54 FR 29507, July 12, 1989; 54 FR 37531, Sept. application for purposes of the avail- 11, 1989, as amended at 54 FR 46898, Nov. 8, ability of any extension period. If the 1989; 59 FR 33210, June 28, 1994] application is substantially inadequate to allow the Agency to make a rea- § 763.175 Enforcement. soned judgment on any of the informa- (a) Failure to comply with any provi- tion required in paragraph (d) of this sion of this subpart is a violation of section and the Agency chooses to re- section 15 of the Act (15 U.S.C. 2614). quest additional information from the (b) Failure or refusal to establish and applicant, the Agency may also deter- maintain records, or to permit access

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to or copying of records as required by and sales and the quantities purchased section 11 of the Act (15 U.S.C. 2610) is or sold. These records must be main- a violation of section 15 of the Act (15 tained for 3 years after the effective U.S.C. 2614). date of the § 763.169 ban for the product. (c) Failure or refusal to permit entry (2) Each person who is subject to the or inspection as required by section 11 requirements of § 763.171 must, for each of the Act (15 U.S.C. 2610) is a violation product required to be labeled, main- of section 15 of the Act (15 U.S.C. 2614). tain a copy of the label used in compli- (d) Violators may be subject to the ance with § 763.171. These records must civil and criminal penalties in section be maintained for 3 years after the ef- 16 of the Act (15 U.S.C. 2615) for each fective date of the ban on distribution violation. in commerce for the product for which (e) The Agency may seek to enjoin the § 763.171 requirements apply. the manufacture, import, processing, [54 FR 29507, July 12, 1989, as amended at 54 or distribution in commerce of asbes- FR 46898, Nov. 8, 1989; 58 FR 34205, June 23, tos-containing products in violation of 1993] this subpart, or act to seize any asbestos-containing products manufactured, § 763.179 Confidential business infor- imported, processed, or distributed in mation claims. commerce in violation of this subpart, (a) Applicants for exemptions under or take any other actions under the au- § 763.173 may assert a Confidential Busi- thority of section 7 or 17 of the Act (15 ness Information (CBI) claim for infor- U.S.C. 2606 or 2616) that are appro- mation in an exemption application or priate. supplement submitted to the Agency under this subpart only if the claim is § 763.176 Inspections. asserted in accordance with this sec- The Agency will conduct inspections tion, and release of the information under section 11 of the Act (15 U.S.C. would reveal trade secrets or confiden- 2610) to ensure compliance with this tial commercial or financial informa- subpart. tion, as provided in section 14(a) of the Act. Information covered by a CBI § 763.178 Recordkeeping. claim will be treated in accordance (a) Inventory. (1) Each person who is with the procedures set forth in 40 CFR subject to the prohibitions imposed by part 2, subpart B. The Agency will §§ 763.165 and 763.167 must perform an place all information not claimed as inventory of the stock-on-hand of each CBI in the manner described in this banned product as of the effective date section in a public file without further of the ban for that product for the ap- notice to the applicant. plicable activity. (b) Applicants may assert CBI claims (2) The inventory shall be in writing only at the time they submit a com- and shall include the type of product, pleted exemption application and only the number of product units currently in the specified manner. If no such in the stock-on-hand of the person per- claim accompanies the information forming the inventory, and the loca- when it is received by the Agency, the tion of the stock. information may be made available to (3) Results of the inventory for a the public without further notice to banned product must be maintained by the applicant. Submitters that claim the person for 3 years after the effec- information as business confidential tive date of the § 763.165 or § 763.167 ban must do so by writing the word ‘‘Con- on the product. fidential’’ at the top of the page on (b) Records. (1) Each person whose ac- which the information appears and by tivities are subject to the bans imposed underlining, circling, or placing brack- by §§ 763.165, 763.167, and 763.169 for a ets ([ ]) around the information product must, between the effective claimed CBI. date of the § 763.165 or § 763.167 ban on (c) Applicants who assert a CBI claim the product and the § 763.169 ban on the for submitted information must pro- product, keep records of all commer- vide the Agency with two copies of cial transactions regarding the prod- their exemption application. The first uct, including the dates of purchases copy must be complete and contain all

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information being claimed as CBI. The (5) Does the information claimed as second copy must contain only infor- confidential appear or is it referred to mation not claimed as CBI. The Agen- in advertising or promotional mate- cy will place the second copy of the rials for the product or the resulting submission in a public file. Failure to end product, safety data sheets or furnish a second copy of the submission other similar materials for the product when information is claimed as CBI in or the resulting end product, profes- the first copy will be considered a pre- sional or trade publications, or any sumptive waiver of the claim of con- other media available to the public or fidentiality. The Agency will notify the to your competitors? If you answered applicant by certified mail that a find- yes, indicate where the information ap- ing of a presumptive waiver of the pears. claim of confidentiality has been made. (6) If the Agency disclosed the infor- The applicant has 30 days from the mation you are claiming as confiden- date of receipt of notification to sub- tial to the public, how difficult would mit the required second copy. Failure it be for the competitor to enter the to submit the second copy will cause market for your product? Consider in the Agency to place the first copy in a your answer such constraints as cap- public file. ital and marketing cost, specialized technical expertise, or unusual proc- (d) Applicants must substantiate all esses. claims of CBI at the time the applicant (7) Has the Agency, another Federal asserts the claim, i.e., when the exemp- agency, or a Federal court made any tion application or supplement is sub- confidentiality determination regard- mitted, by responding to the questions ing this information? If so, provide cop- in paragraph (e) of this section. Failure ies of such determinations. to provide substantiation of a claim at (8) How would your company’s com- the time the applicant submits the ap- petitive position be harmed if the plication will result in a waiver of the Agency disclosed this information? CBI claim, and the information may be Why should such harm be considered disclosed to the public without further substantial? Describe the causal rela- notice to the applicant. tionship between the disclosure and (e) Applicants who assert any CBI harm. claims must substantiate all claims by (9) In light of section 14(b) of TSCA, providing detailed responses to the fol- if you have claimed information from a lowing: health and safety study as confidential, (1) Is this information subject to a do you assert that disclosure of this in- patent or patent application in the formation would disclose a process United States or elsewhere? If so, why used in the manufacturing or proc- is confidentiality necessary? essing of a product or information un- (2) For what period do you assert a related to the effects of asbestos on claim of confidentiality? If the claim is human health and the environment? If to extend until a certain event or point your answer is yes, explain. in time, please indicate that event or time period. Explain why such informa- PART 766—DIBENZO-PARA- tion should remain confidential until DIOXINS/DIBENZOFURANS such point. (3) Has the information that you are Subpart A—General Provisions claiming as confidential been disclosed Sec. to persons outside of your company? 766.1 Scope and purpose. Will it be disclosed to such persons in 766.2 Applicability and duration of this the future? If so, what restrictions, if part. any, apply to use or further disclosure 766.3 Definitions. of the information? 766.5 Compliance. (4) Briefly describe measures taken 766.7 Submission of information. 766.10 Test standards. by your company to guard against 766.12 Testing guidelines. undesired disclosure of the information 766.14 Contents of protocols. you are claiming as confidential to 766.16 Developing the analytical test meth- others. od.

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766.18 Method sensitivity. in part 790 of this chapter and any modifications to such procedures con- Subpart B—Specific Chemical Testing/ tained in this part. Reporting Requirements (d) Section 766.32 specifies conditions 766.20 Who must test. under which persons required to test 766.25 Chemical substances for testing. may request an exclusion or waiver 766.27 Congeners and LOQs for which quan- from testing. titation is required. (e) Deadlines for submission to EPA 766 28 Expert review of protocols. 766.32 Exclusions and waivers. of protocols, reports, studies, and test 766.35 Reporting requirements. results are specified in part 790, sub- 766.38 Reporting on precursor chemical subpart C and § 766.35. stances. (f) Sections 766.10, 766.12, 766.14, AUTHORITY: 15 U.S.C. 2603 and 2607. 766.16, and 766.18 prescribe analytical methods required; § 766.27 prescribes SOURCE: 52 FR 21437, June 5, 1987, unless otherwise noted. target levels of quantitation (LOQ) for each congener for which quantitation Subpart A—General Provisions is required. (g) If results of existing tests or tests § 766.1 Scope and purpose. performed under this part indicate the presence of HDDs/HDFs in the identi- (a) This part identifies requirements fied chemical substance above the LOQ for testing under section 4 of the Toxic specified in § 766.27, § 766.35(c) requires Substances Control Act (TSCA), 15 the following additional reporting on U.S.C. 2603, to ascertain whether cer- the specified chemicals: production, tain specified chemical substances may process, use, exposure and disposal be contaminated with halogenated dibenzodioxins (HDDs)/dibenzofurans data under section 8(a) of TSCA; health (HDFs) as defined in § 766.3, and re- and safety studies under section 8(d) of quirements for reporting under section TSCA; and reports of allegations of sig- 8 of TSCA, 15 U.S.C. 2607. nificant adverse reactions under sec- (b) Section 766.35(b) requires manu- tion 8(c) of TSCA. In some cases, addi- facturers and processors of chemical tional reporting may be required of substances identified in § 766.25 to sub- manufacturers reporting no contami- mit to EPA: nation of the identified chemical sub- (1) Any existing test data showing stances under § 766.35(c)(2). analysis of the chemical substances for (h) Section 766.38 requires manufac- concentrations of HDDs/HDFs, applica- turers of chemical substances produced ble protocols, and the results of the from chemical substances identified as analysis for HDDs/HDFs, (2) allegations possible precursors to HDD/HDF forma- of significant adverse reactions to tion, to report on chemical substances HDDs/HDFs, compiled in accordance produced from such precursors. with part 717 of this chapter, and (3) health and safety studies on the HDDs/ § 766.2 Applicability and duration of this part. HDFs, in accordance with applicable provisions of part 716 of this chapter. (a) Chemical substances subject to test- (c) Section 766.35(a) requires manu- ing. (1) This part is applicable to each facturers and, under certain cir- person who, at any time during the du- cumstances, processors of chemical ration of this part, manufactures (and/ substances identified in § 766.25 to sub- or imports), or processes, a chemical mit letters of intent to test and proto- substance identified under § 766.25. cols for the analysis of the chemical (2) The duration of this part for any substances for the presence of HDDs/ testing requirement for any chemical HDFs. Section 766.20 requires these substance is the period commencing manufacturers and processors to test with the effective date of this part to their chemical substances for the pres- the end of the reimbursement period, ence of HDDs/HDFs. Any submissions as defined in § 766.3, for each chemical must be in accordance with the EPA substance. All reporting requirements Procedures Governing Testing Consent for any chemical substance listed Agreements and Test Rules contained under § 766.25 shall be in effect for the

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same period as the testing require- 1,2,3,6,7,8; 1,2,3,7,8,9; 2,3,4,6,7,8; ment. 1,2,3,4,6,7,8; and 1,2,3,4,7,8,9. (b) Precursor chemical substances. (1) Homolog means a group of isomers This part is applicable to each person that have the same degree of halo- who manufactures (and/or imports) a genation. For example, the homologous chemical substance from any precursor class of tetrachlorodibenzo-p-dioxins chemical substance identified in consists of all dibenzo-p-dioxins con- § 766.38. taining four chlorine atoms. When the (2) The requirement for precursor re- homologous classes discussed in this porting under § 766.38 shall be in effect part are referred to, the following ab- until three years after the effective breviations for the prefix denoting the date of this part. number of halogens are used: (3) Small manufacturers are exempt tetra-, T (4 atoms) from reporting process and reaction penta-, Pe (5 atoms) condition data on chemical substances hexa-, Hx (6 atoms) made from precursor chemical sub- hepta-, Hp (7 atoms) stances listed under § 766.38. HRGC means high resolution gas § 766.3 Definitions. chromatography. HRMS means high resolution mass The definitions in section 3 of TSCA spectrometry. and the definitions of §§ 704.3, 716.3, 717.3, and 790.3 of this chapter also Level of quantitation or LOQ means apply to this part. the lowest concentration at which Congener means any one particular HDDs/HDFs can be reproducibly meas- member of a class of chemical sub- ured in a specific chemical substance stances. A specific congener is denoted within specified confidence limits, as by unique chemical structure, for ex- described in this part. ample 2,3,7,8-tetrachlorodibenzofuran. Polybrominated dibenzofurans refers to Dibenzofuran means any of a family any member of a class of dibenzofurans of compounds which has as a nucleus a with two to eight bromine triple-ring structure consisting of two substituents. benzene rings connected through a pair Polybrominated dibenzo-p-dioxin or of bridges between the benzene rings. PBDD means to any member of a class The bridges are a carbon-carbon bridge of dibenzo-p-dioxins with two to eight and a carbon-oxygen-carbon bridge at bromine substituents. both substitution positions. Polychlorinated dibenzofuran means Dibenzo-p-dioxin or dioxin means any any member of a class of dibenzofurans of a family of compounds which has as with two to eight chlorine a nucleus a triple-ring structure con- substituents. sisting of two benzene rings connected Polychlorinated dibenzo-p-dioxin or through a pair of oxygen atoms. PCDD means any member of a class of Guidelines means the Midwest Re- dibenzo-p-dioxins with two to eight search Institute (MRI) publication chlorine substituents. Guidelines for the Determination of Polyhalogenated dibenzofuran or Polyhalogenated Dioxins and PHDF means any member of a class of Dibenzofurans in Commercial Products, dibenzofurans containing two to eight EPA contract No. 68–02–3938; MRI chlorine, bromine, or a combination of Project No. 8201–A(41), 1985. chlorine and bromine substituents. HDD or 2,3,7,8-HDD means any of the Polyhalogenated dibenzo-p-dioxin or dibenzo-p-dioxins totally chlorinated PHDD means any member of a class of or totally brominated at the following dibenzo-p-dioxins containing two to positions on the molecular structure: eight chlorine substituents or two to 2,3,7,8; 1,2,3,7,8; 1,2,3,4,7,8; 1,2,3,6,7,8; eight bromine substituents. 1,2,3,7,8,9; and 1,2,3,4,7,8,9. Positive test result means: (1) Any re- HDF or 2,3,7,8-HDF means any of the solvable gas chromatographic peak for dibenzofurans totally chlorinated or any 2,3,7,8-HDD or HDF which exceeds totally brominated at the following po- the LOQ listed under § 766.27 for that sitions on the molecular structure: congener, or (2) exceeds LOQs approved 2,3,7,8; 1,2,3,7,8; 2,3,4,7,8; 1,2,3,4,7,8; by EPA under § 766.28.

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Precursor means a chemical sub- § 766.10 Test standards. stance which is not contaminated due Testing required under subpart B of to the process conditions under which this part must be performed using the it is manufactured, but because of its protocols submitted to and reviewed by molecular structure, and under favor- the EPA expert panel established under able process conditions, it may cause § 766.28. All new data, documentation, or aid the formation of HDDs/HDFs in records, protocols, specimens, and re- other chemicals in which it is used as ports generated as a result of testing a feedstock or intermediate. under subpart B of this part must be QA means quality assurance. fully developed and retained in accord- QC means quality control. ance with part 792 of this chapter. Reimbursement period means the pe- These items must be made available riod that begins when the data from during an inspection or submitted to the last test to be completed under this EPA upon request by EPA or its au- part for a specific chemical substance thorized representative. Laboratories listed in § 766.25 is submitted to EPA, conducting testing for submission to and ends after an amount of time equal EPA in response to a test rule promul- to that which had been required to de- gated under section 4 of TSCA must ad- velop that data or 5 years, whichever is here to the TSCA Good Laboratory later. Practices (GLPs) published in part 792 TSCA means the Toxic Substances of this chapter. Sponsors must notify Control Act, 15 U.S.C. 2601 et seq. the laboratory that the testing is being conducted pursuant to TSCA section 4. § 766.5 Compliance. Sponsors are also responsible for ensuring that laboratories conducting the Any person who fails or refuses to testing abide by the TSCA GLP stand- comply with any aspect of this part is ards. At the time test data are sub- in violation of section 15 of TSCA. Sec- mitted, manufacturers must submit a tion 15(1) makes it unlawful for any certification to EPA that the labora- person to fail or refuse to comply with tory performing the testing adhered to any rule or order issued under section the TSCA GLPs. 4. Section 15(3) makes it unlawful for any person to fail or refuse to submit § 766.12 Testing guidelines. information required under this part. Analytical test methods must be de- Section 16 provides that a violation of veloped using methods equivalent to section 15 renders a person liable to the those described or reviewed in Guide- United States for a civil penalty and lines for the Determination of possible criminal prosecution. Under Polyhalogenated Dibenzo-p-dioxins and section 17 of TSCA, the district courts Dibenzofurans in Commercial Products. of the United States have jurisdiction Copies are available from the Director, to restrain any violation of section 15. Environmental Assistance Division (7408), Office of Pollution Prevention § 766.7 Submission of information. and Toxics, U.S.Environmental Protec- All information (including letters of tion Agency, Room E–543B, 1200 Penn- intent, protocols, data, forms, studies, sylvania Ave., NW., Washington, DC and allegations) submitted to EPA 20460, Telephone: (202) 554–1404, TDD: under this part must bear the applica- (202) 544–0551. Copies are also located in ble Code of Federal Regulations (CFR) the public docket for this part (Docket section number (e.g., § 766.20) and must No. OPPTS–83002) and are available for be addressed to: Document Control Of- inspection in the Non-Confidential In- fice, (7407), Information Management formation Center (NCIC) (7407), Office Division, Office of Polution Prevention of Pollution Prevention and Toxics, and Toxics, Environmental Protection U.S. Environmental Protection Agen- Agency, 1200 Pennsylvania Ave., NW., cy, Room B–607 NEM, 401 M St., SW., Washington, DC 20460, ATTN: Dioxin/ Washington, DC 20460, between the Furan Report. hours of 12 p.m. and 4 p.m. weekdays excluding legal holidays. [52 FR 21437, June 5, 1987, as amended at 60 FR 31922, June 19, 1995] [60 FR 34466, July 3, 1995]

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§ 766.14 Contents of protocols. porated by mechanical agitation. Addi- Protocols should include all parts of tional guidance is provided under the Quality Assurance Plan for Measure- § 766.12. ment of Brominated or Chlorinated (c) Sample extraction and cleanup. The Dibenzofurans and Dibenzodioxins, as spiked samples must be treated to sep- stated in the Guidelines. For each arate the HDDs/HDFs from the sample chemical substance and each process, matrix. Methods are reviewed in the the manufacturer must submit a state- Guidelines under § 766.12, but the final ment of how many grades of the chem- method or methods are left to the dis- ical substance it produces, a justifica- cretion of the analyst, provided the in- tion for selection of the specific grade strumental response of the surrogates of chemical substance for testing, spe- meets the criteria listed in the Quality cific plans for collection of samples Assurance Plan for Measurement of from the process stream, naming the Brominated or Chlorinated Dibenzofurans point of collection, the method of col- and Dibenzodioxins, Appendixes B and C lecting the sample, and an estimate of of the Guidelines. Cleanup techniques how well the samples will represent the are described in the Guidelines. These material to be characterized; a description of how control samples (blanks) are chosen at the discretion of the ana- and HDD/HDF-reinforced control sam- lyst to meet the requirements of the ples, or isotopically labeled compounds chemical matrix. (standards) and duplicate samples will (d) Analysis. The method of choice is be handled; a description of the chem- High Resolution Gas Chromatographic/ ical extraction and clean up procedures High Resolution Mass Spectrometric to be used; how extraction efficiency Determination, (HRGC/HRMS) but al- and measurement efficiency will be es- ternate methods may be used if the tablished; and a description of instru- manufacturer can demonstrate that ment hardware and operating condi- the method will reach the target LOQs tions, including type and source of col- as well as HRGC/HRMS. Specific oper- umns, carrier gas and flow rate, operating requirements are found in the ating temperature range, and ion Guidelines. source temperature. § 766.18 Method sensitivity. § 766.16 Developing the analytical test method. The target level of quantitation re- Because of the matrix differences of quired under § 766.27 for each HDD/HDF the chemicals listed for testing, no one congener is the level which must be at- method for sample selection, prepara- tempted for each resolved HRGC peak tion, extraction and clean up is pre- for that congener. For at least one scribed. For analysis, High Resolution product sample, at least two analyses Gas Chromatography (HRGC) with of the same isotopically labeled HDD/ High Resolution Mass Spectrometry HDF internal calibration standards (HRMS) is the method of choice, but spiked to a final product concentration other methods may be used if they can equal to the LOQ for that congener be demonstrated to reach the target must be reproducibly extracted, LOQs as well as HRGC/HRMS. cleaned up, and quantified to within (a) Sample selection. The chemical ±20 percent of each other. For each product to be tested should be sampled spiked product sample, the signal to so that the specimens collected for noise ratio for the calibration standard analysis are representative of the peaks after complete extraction and whole. Additional guidance for sample cleanup must be 10:1 or greater. The re- selection is provided under § 766.12. covery of the internal calibration (b) Sample preparation. The sample standards in the extracted and cleaned must be mechanically homogenized up product samples must be within 50 and subsampled as necessary. Subsam- to 150 percent of the amount spiked, ples must be spiked or reinforced with surrogate compounds or with standard and the results must be corrected for stock solutions, and the surrogates or recovery. standards must be thoroughly incor-

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Subpart B—Specific Chemical until a proposed study plan is sub- Testing/Reporting Requirements mitted for required testing. (d) Manufacturers, importers, and § 766.20 Who must test. processors who are subject to this part (a) Any person who manufactures, must comply with the test rule devel- imports, or processes a chemical sub- opment and exemption procedures in stance listed in § 766.25 must test that part 790 of this chapter, except as chemical substance and must submit modified in this part. appropriate information to EPA ac- § 766.25 Chemical substances for test- cording to the schedules described in ing. § 766.35. Chemical substances manufactured, imported or processed between (a) Listing of chemical substances. January 1, 1984 and the date of promul- Chemical substances required to be gation of this part are subject to test- tested for HDDs/HDFs under this rule ing upon the effective date of this part. are listed in this section. The listing is All other chemical substances are sub- by Chemical Abstracts Service (CAS) ject to testing immediately upon man- Number and common name. ufacture, import or processing. EPA NOTE: For purposes of guidance only, EPA expects that only manufacturers and lists the chemical substances subject to test- importers will perform testing, and ing under this part in two classes—those that the cost of testing will be passed known to be manufactured or imported be- on to processors through the pricing tween January 1, 1984, and promulgation of mechanism, thereby enabling them to this part, and those not known to be manufactured or imported at the time of promul- share in the cost of testing. However, gation of this part. processors will be called upon to spon- (1) Chemicals substances known to be sor testing should manufacturers and manufactured between January 1, 1984 importers fail to do so. A processor and date of promulgation of this part. may apply for an exemption from testing upon certification to EPA that a CAS No. Chemical name manufacturer or importer is testing 79–94–7 Tetrabromobisphenol-A. the chemical substance which that per- 118–75–2 2,3,5,6-Tetrachloro-2,5-cyclohexadiene-1,4- son processes. dione. (b) If no manufacturer or importer 118–79–6 2,4,6-Tribromophenol. 120–83–2 2,4-Dichlorophenol. described in § 766.20 submits a letter of 1163–19–5 Decabromodiphenyloxide. intent to perform testing within the 4162–45–2 Tetrabromobisphenol-A-bisethoxylate. period described under § 766.35(a), or an 21850–44–2 Tetrabromobisphenol-A-bis-2,3-dibromopropyl exemption application under § 790.45(a), ether. 25327–89–3 Allyl ether of tetrabromobisphenol-A. or a request for an exclusion or waiver 32534–81–9 Pentabromodiphenyloxide. under § 766.32, EPA will issue a notice 32536–52–0 Octabromodiphenyloxide. in the FEDERAL REGISTER to notify all 37853–59–1 1,2-Bis(tribromophenoxy)-ethane. processors of that chemical substance. 55205–38–4 Tetrabromobisphenol-A diacrylate. The notice will state that EPA has not (2) Chemicals not known to be manufac- received any of the documents de- tured between January 1, 1984 and the scribed in the previous sentence, and date of promulgation of this part. that current processors will have 30 days to submit either a letter of intent CAS No. Chemical name to perform the test or submit an ex- 79–95–8 Tetrachlorobisphenol-A. emption application. 87–10–5 3,4′,5-Tribromosalicylanilide. (c) If no manufacturer, importer or 87–65–0 2,6-Dichlorophenol. processor submits a letter of intent to 95–77–2 3,4-Dichlorophenol. 95–95–4 2,4,5-Trichlorophenol. perform testing of a specific chemical 99–28–5 2,6-Dibromo-4-nitrophenol. substance produced by a specific proc- 120–36–5 2[2,4-(Dichlorophenoxy)]-propionic acid. ess, EPA will notify all manufacturers, 320–72–9 3,5-Dichlorosalicyclic acid. importers, and processors, either by 488–47–1 Tetrabromocatechol. 576–24–9 2,3-Dichlorophenol. notice in the FEDERAL REGISTER or by 583–78–8 2,5-Dichlorophenol. letter, that all exemption applications 608–71–9 Pentabromophenol. will be denied and that within 30 days 615–58–7 2,4-Dibromophenol. 933–75–5 2,3,6-Trichlorophenol. all manufacturers, importers, and proc- 1940–42–7 4-Bromo-2,5-dichlorophenol. essors will be in violation of this part 2577–72–2 3,5-Dibromosalicylanilide.

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CAS No. Chemical name § 766.28 Expert review of protocols.

3772–94–9 Pentachlorophenyl laurate. EPA will gather a panel of experts in 37853–61–5 Bismethylether of tetrabromobisphenol-A. analysis of chemical matrices for Alkylamine tetrachlorophenate. HDDs/HDFs to review the protocols for Tetrabromobisphenol-B. testing submitted to EPA. The panel members will be employees of EPA (b) If the same Grade to be tested. and/or of other U.S. Government agen- process is used to manufacture all cies who have had experience in anal- grades of the same chemical substance, ysis of chemical matrices and/or chem- only one grade need be tested. The ical wastes for HDDs/HDFs. The panel grade to be tested must be the grade will recommend to the Director, EPA subject to the most intense heat and Office of Pollution Prevention and alkalinity for the longest duration of Toxics, whether the protocol submitted time, manufactured under each dif- is likely to allow analysis down to the ferent process. If the heat, alkalinity target LOQs, or if not, whether the pro- and duration of reaction do not differ tocol represents a good faith effort on for various grades, the test substance the part of the tester to achieve the must be the grade of chemical sub- lowest possible LOQs. The final deter- stance with the highest volume of mination to accept or reject the pro- sales. tocol will be made by the Director, Of- fice of Pollution Prevention and § 766.27 Congeners and LOQs for Toxics. EPA will review the submitted which quantitation is required. protocols as rapidly as possible and Quantitation at the target LOQ will complete the review within 90 days shown for each of the following HDDs/ after receipt. EPA may require submis- HDFs which may be present in the sion of revised protocols. Comments chemical substances is required for the and recommendations will be trans- chemical substances listed under mitted to the submitter, and if revi- § 766.25. Analysis must take place for sions are required, a final protocol either chlorinated or brominated must be submitted to EPA within 90 dibenzodioxins or dibenzofurans, days after EPA transmits such rec- whichever is predominantly expected ommendations. to occur in the chemical substance to be tested. Only chlorinated and § 766.32 Exclusions and waivers. brominated congeners need be quan- (a) Reasons for exclusions and waivers. tified; for chemical substances con- Any person subject to the testing retaining predominantly chlorine atoms, quirements of this part may request an only congeners totally chlorinated at exclusion or waiver from testing for the numbered positions need be quan- any one of the following reasons: tified; for chemical substances con- (1) Exclusions may be granted if. (i) taining predominantly bromine atoms, Testing of the appropriate grade of the only congeners totally brominated at chemical substance has already been the numbered positions need be quan- carried out, either analytical testing at tified. the lowest LOQ possible, with appropriate QA/QC, or a well-designed bio- Chlorinated dioxins Brominated dioxins LOQ assay with appropriate QA/QC or; 2,3,7,8-TCDD ...... 2,3,7,8-TBDD ...... 0.1 ppb. (ii) Process and reaction conditions 1,2,3,7,8-PeCDD ...... 1,2,3,7,8-PeBDD ...... 0.5 ppb. of the chemical substance such that no 1,2,3,4,7.8-HxCDD ...... 1,2,3,4,7,8-HxBDD ...... 2.5 ppb. HDDs/HDFs could be produced under 1,2,3,6,7,8-HxCDD ...... 1,2,3,6,7,8-HxBDD ...... 2.5 ppb. 1,2,3,7,8,9-HxCDD ...... 1,2,3,7,8,9-HxBDD ...... 2.5 ppb. those conditions; 1,2,3,4,6,7,8-HpCDD ... 1,2,3,4,6,7,8-HpBDD ... 100 ppb. (2) Waivers may be granted if. (i) A re- 2,3,7,8-TCDF ...... 2,3,7,8-TBDF ...... 1 ppb. sponsible company official certifies 1,2,3,7,8-PeCDF ...... 1,2,3,7,8-PeBDF ...... 5 ppb. that the chemical substance is pro- 2,3,4,7,8-PeCDF ...... 2,3,4,7,8-PeBDF ...... 5 ppb. duced only in quantities of 100 kilo- 1,2,3,4,7,8-HxCDF ...... 1,2,3,4,7,8-HxBDF ...... 25 ppb. 1,2,3,6,7,8-HxCDF ...... 1,2,3,6,7,8-HxBDF ...... 25 ppb. grams or less per year, only for re- 1,2,3,7,8,9-HxCDF ...... 1,2,3,7,8,9-HxBDF ...... 25 ppb. search and development purposes; or 2,3,4,6,7,8-HxCDF ...... 2,3,4,6,7,8-HxBDF ...... 25 ppb. (ii) In the judgement of EPA, the cost 1,2,3,4,6,7,8-HpCDF ... 1,2,3,4,6,7,8-HpBDF ... 1 ppm. of testing would drive the chemical 1,2,3,4,7,8,9-HpCDF ... 1,2,3,4,7,8,9-HpBDF ... 1 ppm. substance off the market, or prevent

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resumption of manufacture or import exemption application. These letters of the chemical substance, if it is not must be submitted no later than Sep- currently manufactured, and the chem- tember 3, 1987. ical substance will be produced so that (ii) Persons who commence manufac- no unreasonable risk will occur due to ture, import or processing of a chem- its manufacture, import, processing, ical substance listed under § 766.25 that distribution, use, or disposal. (In this has not been manufactured, imported case, the manufacturer must submit to or processed between January 1, 1984 EPA all data supporting the deter- and the effective date of this part must mination.) submit under § 790.45 of this chapter, (iii) Waivers may be appropriately within 60 days after the commence- conditioned with respect to such fac- ment of manufacture, import, or proc- tors as time and conditions of manu- essing of the chemical substance, a let- facture or use. The grade of ter of intent to test or an exemption decabromodiphenyl oxide produced by application. Dow Chemical Company (Dow) for the (iii) Persons who commence manu- National Toxicology Program (NTP) facture, import or processing of a bioassay on that chemical is excluded chemical substance listed under § 766.25 from the testing requirement under between the effective date of this part this part. Provided, however, that this and the end of the reimbursement pe- exclusion will not apply if Dow fails to riod for that particular chemical sub- supply to EPA within 60 days of the ef- stance produced by a specific process fective date of this section evidence must submit under § 790.45 of this chap- showing which grade was used for the ter, within 60 days after the commence- NTP bioassay. ment of manufacture, import or proc- (b) Timing. Exclusion or waiver re- essing of the chemical substance, a let- quests and detailed supporting data ter of intent to test or an exemption must be submitted to EPA within 60 application. days from the effective date of this part for persons manufacturing, im- (2) Protocols. (i) Each person who is porting or processing a chemical sub- manufacturing or processing a chem- stance as of the date of promulgation, ical substance listed in § 766.25 as of the or 60 days prior to the date of resump- effective date of this part who submits tion of manufacture or import for a a notice of intent to test under chemical substance produced by a spe- § 766.35(a)(1) must submit a protocol for cific process if the chemical substance the test as follows: is not manufactured, imported or proc- (A) The protocols for each essed as of the date of promulgation. chlorinated chemical substance pro- (c) Publication. Within 10 days of reduced by each process to be tested ceipt of any exclusion or waiver re- must be submitted to EPA no later quest, EPA will issue in the FEDERAL than 12 months after the effective date REGISTER a notice of such receipt. EPA of this part. will also issue a notice of its decision (B) The protocol for each brominated on each exclusion or waiver request chemical substance produced by each within 60 days of receipt. process to be tested must be submitted (d) Decision. The EPA Director of the to EPA no later than 24 months after Office of Pollution Prevention and the effective date of this part except Toxics will make the decision to grant for the following chemicals. or deny waivers or exclusions. (1) The deadline for submitting the protocols for tetrabromobisphenol-A § 766.35 Reporting requirements. (CAS No. 79–94–7); 2,4,6 tribromophenol (a) Letters of intent, exemption applica- (CAS. No. 118–79–6); tions, and protocols—(1) Letters of Intent. decabromodiphenyloxide (CAS No. (i) Persons who have manufactured or 1163–19–5); and 1,2- imported chemical substances listed bis(tribromophenoxy)-ethane (CAS No. under § 766.25 between January 1, 1984, 37853–59–1) is January 31, 1991. and the effective date of this part are (2) The deadline for submitting proto- required to submit under § 790.45 of this cols for octabromodiphenyloxide (CAS chapter a letter of intent to test or an No. 32536–52–0) and allyl ether of

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tetrabromobisphenol-A (CAS No. 25327– factured or processed as of the effective 89–3) is January 31, 1991. date of this part, a person who begins (3) The deadline for submitting proto- manufacture and submits a notice of cols for pentabromodiphenyloxide (CAS intent to test must submit protocols No. 32534–81–9) is February 6, 1995. The for the test as follows: deadline for submitting (A) Except as noted for the submitter tetrabromobisphenol-A-bisethoxylate and substance specified in the fol- (CAS No. 4126–45–2) is January 31, 1991. lowing table, protocols for testing (4) The deadline for submitting proto- must be submitted 12 months after cols for 3,4′,5-tribromosalicylanilide (CAS No. 87–10–5) is September 5, 1990. manufacture or importation begins for (ii) For chemical substances pro- chlorinated chemical substances. duced by a specific process not manu-

CAS No. Submitter Chemical Due date

118–75–2 Rhone-Poulenc ...... 2,3,5,6-tetrachloro-2,5-cyclohexaniene-1,4-dione ...... March 4, 1994

(B) Protocols for testing must be sub- quired to submit copies of such studies mitted 24 months after manufacture to EPA no later than October 5, 1987 or begins for brominated chemical sub- 90 days after the person first manufac- stances. tures or imports the chemical sub- (iii) For persons who have been stance, whichever is later. The fol- granted exemptions, waivers or exclu- lowing provisions of part 716 of this sions from testing, protocols must be chapter apply to submission of these submitted 12 months after expiration studies: §§ 716.3, 716.10(a) (1) and (4); of the exemption, waiver or exclusion 716.20(a) (1), (2), (3), (4), (7), (8) and (10); for chlorinated chemical substances, 716.25; 716.30; 716.35(a) (1), (2), and (4) [if and 24 months after expiration of the applicable]; 716.35 (b) and (c); 716.40 (a) exemption, waiver or exclusion for and (b); 716.50; 716.55; and 716.60(a)(2). brominated chemical substances. (3) No later than October 5, 1987 or 90 (b) Information that must be submitted days after the person first manufac- to EPA. (1) Persons who manufacture or tures or imports the substance listed in import a chemical substance listed § 766.25, any manufacturer or importer under § 766.25 must report no later than of a chemical substance listed in October 5, 1987 or 90 days after the per- § 766.25 must submit records required to son first manufactures or imports the be held under part 717 of this chapter chemical substance, whichever is later, on any HDDs/HDFs. the results of all existing test data (4) Test results. (i) Test results must which show that chemical substance be submitted to EPA not later than 270 has been tested for the presence of days after EPA’s transmission of com- HDDs/HDFs. ments or 180 days after a final protocol (2) Any manufacturer or importer of is submitted to EPA, whichever is a chemical substance listed in § 766.25 shorter, except as noted for the submit- in possession of unpublished health and ters and substances specified in the fol- safety studies on HDDs/HDFs is re- lowing table:

CAS No. Submitter Chemical Due Date Effective Date

79–94–7 Great Lakes Tetrabromobisphenol-A May 26, 1992 May 28, 1993 79–94–7 Ethyl Tetrabromobisphenol-A August 10, 1992 May 28, 1993 79–94–7 Ameribrom Tetrabromobisphenol-A April 15, 1994 September 29, 1995 87–10–5 Pfister 3,4′,5-tribromosalicylanilide 45 days after protocol ap- May 28, 1993 proval 118–75–2 Rhone-Poulenc Inc. 2,3,5,6-tetrachloro-2,5- July 5, 1996 June 30, 1997 cyclohexadiene-1,4-dione 118–79–6 Great Lakes 2,4,6-Tribromophenol May 26, 1992 May 28, 1993 1163–19–5 Ameribrom Decabromodiphenyloxide April 15, 1994 September 29, 1995 1163–19–5 Ethyl Decabromodiphenyloxide May 26, 1992 May 28, 1993

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CAS No. Submitter Chemical Due Date Effective Date

1163–19–5 Great Lakes Decabromodiphenyloxide May 26, 1992 May 28, 1993 4162–45–2 Great Lakes Tetrabromobisphenol-A- June 2, 1993 September 8, 1994 bisethoxylate 25327–89–3 Great Lakes Allyl Ether of August 10, 1992 May 28, 1993 Tetrabromobisphenol-A 32534–81–9 Great Lakes Pentabromodiphenyloxide March 22, 1993 September 8, 1994 32534–81–9 Akzo Chemicals Pentabromodiphenyloxide February 6, 1995 September 29, Inc. 1995 32534–81–9 Ameribrom Pentabromodiphenyloxide March 22, 1993 September 8, 1994 32536–52–0 Ameribrom Octabromodiphenyloxide January 8, 1993 September 29, 1995 32536–52–0 Ethyl Octabromodiphenyloxide May 15, 1994 May 28, 1993 32536–52–0 Great Lakes Octabromodiphenyloxide May 26, 1992 May 28, 1993 37853–59–1 Great Lakes 1,2-bis(tribromophenoxy)ethane January 24, 1995 September 29, 1995

(ii) For purposes of reporting test re- son but not from others, EPA may sults to EPA, and for further reporting issue a notice in the FEDERAL REGISTER triggered by a positive test result listing that chemical substance and re- under § 766.35(c), a positive test result quiring any person manufacturing, im- is defined at § 766.3. porting or processing that chemical (iii) Reporting of test results must substance who has not submitted a follow procedures set out in part 790 of positive test result to submit the infor- this chapter, except as modified in this mation required in Part II of EPA part. Form 7710–51. Such a notice will be (c) Information required to be submitted published only if EPA needs additional to EPA after submission of a positive test process data to make a determination result. (1) Any person who submits a of unreasonable risk. positive test result for a specific chem- (d)–(e) [Reserved] ical substance listed under § 766.25 must submit to EPA no later than 90 days (f) Effective date. (1) The effective after the date of submission of the date of this final rule is July 6, 1987, ex- positive test result the following: cept for paragraphs (a)(2)(i)(B) intro- (i) A completed form (EPA 7710-51) ductory text, (a)(2)(i)(B)(1), for that chemical substance. The form (a)(2)(i)(B)(2), (a)(2)(i)(B)(3), and instructions are available from the (a)(2)(i)(B)(4), the table in paragraph Environmental Assistance Division (a)(2)(ii)(A), and the table in paragraph (7408), Office of Pollution Prevention (b)(4)(i) of this section. and Toxics, Environmental Protection (2) The effective date for paragraph Agency, 1200 Pennsylvania Ave., NW., (a)(2)(i)(B) introductory text, Washington, DC 20460. One form must (a)(2)(i)(B)(1), (a)(2)(i)(B)(2), and be submitted for each chemical sub- (a)(2)(i)(B)(4), is May 21, 1991. The effec- stance for which a positive test result tive date of paragraphs (a)(2)(i)(B)(3), has been submitted. and the table in paragraph (a)(2)(ii)(A) (ii) Health and safety studies for the is September 29, 1995. The effective chemical substance for which a posi- date of paragraph (b)(4)(i) introductory tive test result has been reported. The text is May 28, 1993, and the effective following provisions of part 716 of this date of the entries in the table in para- chapter apply to submission of these graph (b)(4)(i) is shown in the effective studies: §§ 716.3; 716.10 (a) (1), (2), (3) and dates column of the table. (4); 716.20; 716.25; 716.30; 716.35(a) (1), (2), and (4), [if applicable]; 716.35 (b) and (c); 716.40 (a) and (b); 716.50; 716.55; 716.60(a)(2). (iii) Copies of records on the chemical substances required to be held under part 717 of this chapter. (2) If a positive test result on a chemical substance is received from one per-

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(3) The guidelines and other test CAS No. Chemical name methods cited in this rule are ref- 108–70–3 1,3,5-Trichlorobenzene. erenced as they exist on the effective 108–86–1 Bromobenzene. date of the final rule. 108–90–7 Chlorobenzene. 117–18–0 1,2,4,5-Tetrachloro-3-nitrobenzene. [52 FR 21437, June 5, 1987, as amended at 56 120–82–1 1,2,4-Trichlorobenzene. FR 23229, May 21, 1991; 57 FR 24960, June 12, 348–51–6 o-Chorofluorobenzene. 1992; 58 FR 30991, May 28, 1993, 58 FR 34205, 350–30–1 3-Chloro-4-fluoronitrobenzene. June 23, 1993; 59 FR 46356, Sept. 8, 1994; 60 FR 615–67–8 Chlorohydroquinone. 31922, June 19, 1995; 60 FR 50433, Sept. 29, 1995; 626–39–1 1,3,5-Tribromobenzene. 60 FR 56955, Nov. 13, 1995; 62 FR 35105, June 827–94–1 2,6-Dibromo-4-nitroaniline. 30, 1997] (b) Persons required to report. All per- § 766.38 Reporting on precursor chem- sons who manufacture or import a ical substances. chemical product produced using any (a) Identification of precursor chemical of the chemical substances listed in substances. Precursor chemical subparagraph (a) of this section as feed- stances are produced under conditions stocks or intermediates must report no that will not yield HDDs and HDFs, but later than September 29, 1987. Small their molecular structure is conducive manufacturers and those manufactur- to HDD/HDF formation under favorable ers and importers who produce the pre- reaction conditions when they are used cursor chemical substances in quan- to produce other chemicals or prod- tities of 100 kilograms or less per year ucts. The following precursor chemical only for research and development pur- substances are identified by Chemical poses are not required to report under Abstract Service (CAS) number and this section name. (c) Data to be reported. Manufacturers and importers of chemical products CAS No. Chemical name made from precursor chemical substances identified in paragraph (a) of 85–22–3 ... Pentabromoethylbenzene. 87–61–6 ... 1,2,3-Trichlorobenzene. this section must report process and 87–84–3 ... 1,2,3,4,5-Pentabromo-6-chloro-cyclohexane. reaction condition data on Part II of 89–61–2 ... 1,4-Dichloro-2-nitrobenzene. EPA Form 7710–51 for each chemical 89–64–5 ... 4-Chloro-2-nitrophenol. 89–69–0 ... 2,4,5-Trichloronitrobenzene. product. A separate EPA Form 7710–51 92–04–6 ... 2-Chloro-4-phenylphenol. must be submitted for each chemical 94–74–6 ... 4-Chloro-o-toloxy acetic acid. product reported, and the precursor 94–81–5 ... 4-(2-Methyl-4-chlorophenoxy) butyric acid. chemical substance used must be iden- 95–50–1 ... o-Dichlorobenzene. 95–56–7 ... o-Bromophenol. tified. All forms must be submitted to 95–57–8 ... o-Chlorophenol. EPA no later than September 29, 1987. 95–88–5 ... 4-Chlororesorcinol. 95–94–3 ... 1,2,4,5-Tetrachlorobenzene. [52 FR 21437, June 5, 1987, as amended at 60 97–50–7 ... 5-Chloro-2,4-dimethoxyaniline. FR 31922, June 19, 1995] 99–30–9 ... 2,6-Dichloro-4-nitroaniline. 99–54–7 ... 1,2-Dichloro-4-nitrobenzene. 106–46–7 p-Dichlorobenzene. PARTS 767–789 [RESERVED]

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