Federal Register/Vol. 69, No. 120/Wednesday, June

Federal Register / Vol. 69, No. 120 / Wednesday, June 23, 2004 / Rules and Regulations 34945

ENVIRONMENTAL PROTECTION Agency, 1200 Pennsylvania Ave., NW., tolerance for residues of n-propyl AGENCY Washington, DC 20460–0001; telephone lactate, also known as lactic acid, n- number: (703) 308–8033; e-mail address: propyl ester, (S) (CAS Reg. No. 53651– 40 CFR Part 180 [email protected]. 69–7). There were no comments [OPP–2004–0040; FRL–7362–3] SUPPLEMENTARY INFORMATION: received in response to the notice of filing. I. General Information Lactic acid, n-propyl ester, (S); Section 408(b)(2)(A)(i) of the FFDCA Exemption from the Requirement of a A. Does this Action Apply to Me? allows EPA to establish an exemption Tolerance You may be potentially affected by from the requirement for a tolerance (the AGENCY: Environmental Protection this action if you are an agricultural legal limit for a pesticide chemical Agency (EPA). producer, food manufacturer, or residue in or on a food) only if EPA ACTION: Final rule. pesticide manufacturer. Potentially determines that the tolerance is ‘‘safe.’’ affected entities may include, but are Section 408(b)(2)(A)(ii) of the FFDCA SUMMARY: This regulation establishes an not limited to: defines ‘‘safe’’ to mean that ‘‘there is a exemption from the requirement of a • Crop production (NAICS code 111) reasonable certainty that no harm will tolerance for residues of lactic acid, n- • Animal production (NAICS code result from aggregate exposure to the propyl ester, (S) on raw agricultural 112) pesticide chemical residue, including commodities when used as an inert • Food manufacturing (NAICS code all anticipated dietary exposures and all ingredient in pesticide formulations 311) other exposures for which there is • applied to growing crops or to raw Pesticide manufacturing (NAICS reliable information.’’ This includes agricultural commodities after harvest, code 32532) exposure through drinking water and in or animals. PURAC America, Inc. This listing is not intended to be residential settings, but does not include submitted a petition to EPA under the exhaustive, but rather provides a guide occupational exposure. Section Federal Food, Drug, and Cosmetic Act, for readers regarding entities likely to be 408(b)(2)(C) of the FFDCA requires EPA as amended by the Food Quality affected by this action. Other types of to give special consideration to Protection Act of 1996, requesting an entities not listed in this unit could also exposure of infants and children to the exemption from the requirement of a be affected. The North American pesticide chemical residue in tolerance. This regulation eliminates the Industrial Classification System establishing a tolerance and to ‘‘ensure (NAICS) codes have been provided to need to establish a maximum that there is a reasonable certainty that assist you and others in determining permissible level for residues of lactic no harm will result to infants and whether this action might apply to acid, n-propyl ester, (S). children from aggregate exposure to the certain entities. If you have any DATES: This regulation is effective June pesticide chemical residue. . . .’’ 23, 2004. Objections and requests for questions regarding the applicability of EPA performs a number of analyses to hearings must be received on or before this action to a particular entity, consult determine the risks from aggregate August 23, 2004. the person listed under FOR FURTHER INFORMATION CONTACT. exposure to pesticide residues. First, ADDRESSES: To submit a written EPA determines the toxicity of objection or hearing request follow the B. How Can I Access Electronic Copies pesticides. Second, EPA examines detailed instructions as provided in of this Document and Other Related exposure to the pesticide through food, SUPPLEMENTARY Information? Unit VIII. of the drinking water, and through other INFORMATION. EPA has established a In addition to using EDOCKET at exposures that occur as a result of docket for this action under Docket ID (http://www.epa.gov/edocket/), you may pesticide use in residential settings. number OPP–2004–0040. All access this Federal Register document documents in the docket are listed in electronically through the EPA Internet III. Inert Ingredient Definition the EDOCKET index at http:// under the ‘‘Federal Register’’ listings at www.epa.gov/edocket. Although listed Inert ingredients are all ingredients http://www.epa.gov/fedrgstr/. A that are not active ingredients as defined in the index, some information is not frequently updated electronic version of in 40 CFR 153.125 and include, but are publicly available, i.e., CBI or other 40 CFR part 180 is available at E–CFR not limited to, the following types of information whose disclosure is BetaSite Two at http:// ingredients (except when they have a restricted by statute. Certain other www.gpoaccess.gov/ecfr/. material, such as copyrighted material, pesticidal efficacy of their own): is not placed on the Internet and will be II. Background and Statutory Findings Solvents such as alcohols and publicly available only in hard copy In the Federal Register of October 24, hydrocarbons; surfactants such as form. Publicly available docket 2003 (68 FR 60987) (FRL–7330–6), EPA polyoxyethylene polymers and fatty materials are available either issued a notice pursuant to section acids; carriers such as clay and electronically in EDOCKET or in hard 408(d)(3) of the Federal Food, Drug, and diatomaceous earth; thickeners such as copy at the Public Information and Cosmetic Act (FFDCA), 21 U.S.C. carrageenan and modified cellulose; Records Integrity Branch (PIRIB), Rm. 346a(d)(3), announcing the filing of a wetting, spreading, and dispersing 119, Crystal Mall #2, 1921 Jefferson pesticide tolerance petition (PP OF6180) agents; propellants in aerosol Davis Hwy., Arlington, VA. This docket by PURAC America, Inc., 111 Barclay dispensers; microencapsulating agents; facility is open from 8:30 a.m. to 4 p.m., Blvd., Lincolnshire Corporate Center, and emulsifiers. The term ‘‘inert’’ is not Monday through Friday, excluding legal Lincolnshire, IL 60069. This notice intended to imply nontoxicity; the holidays. The docket telephone number included a summary of the petition ingredient may or may not be is (703) 305–5805. prepared by the petitioner PURAC chemically active. Generally, EPA has FOR FURTHER INFORMATION CONTACT: America, Inc. exempted inert ingredients from the Princess Campbell, Registration The petition requested that 40 CFR requirement of a tolerance based on the Division (7505C), Office of Pesticide 180.950 be amended by establishing an low toxicity of the individual inert Programs, Environmental Protection exemption from the requirement of a ingredients.

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IV. Toxicological Profile one female had slight dermal opacity and there was a vascularization Consistent with section 408(b)(2)(D) encrustation on day 1. No treatment of the cornea. Iridial and conjunctival of the FFDCA, EPA has reviewed the related findings were observed on effects were also present. The iridial available scientific data and other necropsy. The dermal lethal dose (LD)50 irritation cleared by day 14 and the eye relevant information in support of this was greater than 2,000 milligrams/liter was no longer positive for chemosis and action and considered its validity, (mg/L). This is Toxicity Category III. conjunctival redness at 21 days. This is completeness and reliability and the 2. Acute dermal irritation study in the Toxicity Category I. rabbit. One half milliliter (mL) of n- relationship of this information to B. Structure-Activity-Relationship (SAR) propyl lactate (99.5%) was distributed human risk. EPA has also considered Assessment available information concerning the over each of three patches measuring variability of the sensitivities of major approximately 2.5 x 2.5 centimeter (cm). Lactic acid, n-propyl ester, (S), identifiable subgroups of consumers, Three rabbits were used and each rabbit belongs to the same class of lactate including infants and children. The received one patch applied to a skin site esters as lactic acid, ethyl ester and nature of the toxic effects caused by with 4–hour occluded exposure. All lactic acid, n-butyl ester. Structurally lactic acid, n-propyl ester, (S) are scores were zero for erythema and for these three chemicals which are all discussed in this unit. oedema at 7 and 14 days. There was esters of lactic acid differ only in the slight scaliness at all three sites at day presence of the ethyl, n-propyl, or n- A. Agency-Reviewed Studies 7 but not at day 14. This is Toxicity butyl side chain. SAR assessments in 1. Acute dermal toxicity in the rat. Category IV. which the chemical’s structural Five males and five female adult 3. Acute eye irritation study in the similarity to other chemicals is used to outbred albino rats received 24–hour rabbit. One-tenth mL of n-propyl lactate determine toxicity have been performed occluded dermal exposure to a dose of (99.5%) was instilled into the right eye for all three chemicals. The assessments 2,000 milligram per kilogram (mg/kg) of of a single young adult New Zealand did not identify any concerns for n-propyl lactate (99.5%). There was no White rabbit with no subsequent wash. carcinogenicity or developmental mortality. All five males and four of five The exposed eye scored positive for toxicity for the lactate esters. In fact, all females lost weight from day 0 to day corneal opacity at 1, 24, 48, and 72 three chemicals were judged to be of 3, but five males and three females had hours, and at 7, 14, 21, 25, 28, 35, and low concern. For comparison purposes slight weight gains during the period 42 days. At 35, and 42 days three the physical/chemical properties are from day 0 to day 14. Two males and quarters of the cornea was still showing given in Table 1 below.

TABLE 1.—PHYSICIAL/CHEMICAL PROPERTIES

Test Results (M) measured (E) estimated Parameter Ethyl Lactate (taken from Butyl Lactate (taken from SAR Assess- SAR Assessment, sub- n-Propyl lactate ment, NIOSH pocket guide, submitted mitted information) information)

Physical form Liquid Liquid Liquid

Molecular weight 118 132.16 146

Solubility (water) @ 20 °C Completely miscible Miscible Slight (NIOSH) 4.5 g in 100 g water

Vapor pressure (mmHg) @ 1.7 1.3 0.4 (NIOSH) 20 °C 0.2

Octanol/water partition 0.06 0.51 1.1 coefficent log Kow 0.31 (E) (SAR) 1.4 (E) (SAR)

Detailed discussions of the toxicity the Federal Register of September 3, C. Comparison of Toxicity Data for data for ethyl and butyl lactate esters 2002 (67 FR 56225) (FRL–7196–6). Lactate Esters were published in the Final Rule Table 2 below compares the toxicity entitled ‘‘Lactic Acid, n-Butyl Ester and data discussed in that final rule and the Lactic Acid, Ethyl Ester’’; Exemptions available data for lactic acid, n-propyl from the Requirement of a Tolerance, in ester, (S).

TABLE 2.—COMPARISON OF TOXICITY DATA FOR LACTATE ESTERS

Toxicity Study Ethyl Lactate n-Propyl Lactate Butyl Lactate

Acute oral LD50 > 2,000 mg/kg *LD50 > 2,000 mg/kg (Toxicity Category LD50 > 2,000 mg/kg III)

3 Acute inhalation ---- *LC50 > 5,000 mg/m (Toxicity Category LC50 > 5.14 mg/L IV)

Acute dermal *LD50 >5 g/kg LD50 > 2,000 mg/kg (Toxicity Category *LD50 > 5 g/kg III)

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TABLE 2.—COMPARISON OF TOXICITY DATA FOR LACTATE ESTERS—Continued

Toxicity Study Ethyl Lactate n-Propyl Lactate Butyl Lactate

Dermal irritation Non-irritating Non-irritating to skin (Toxicity Category Irritating IV)

Eye irritation Possible eye irritant Severely irritating to eye (Toxicity Cat- Possible eye irritant egory I)

Dermal developmental NOAEL 3,619 mg/kg ------*These values were obtained from an article entitled ‘‘Safety Assessment of n-Propyl-L-Lactate,’’ published by Clary et al., 1998, in the Journal of Regulatory Toxicology and Pharmacology. The Agency did not review these studies which were supplied as supporting information; however, the studies which provided these results were conducted according to OECD guidelines.

D. Metabolism of Lactate Esters underestimated, it is assumed that the margin of safety for infants and children In mammals simple esters such as inert ingredients are used on all crops in the case of threshold effects to ethyl, butyl, and n-propyl lactate readily and 100% of all crops are ‘‘treated’’ with account for prenatal and postnatal the inert ingredient. Given the low undergo hydrolysis, yielding the alcohol toxicity and the completeness of the toxicity of the lactate esters as a class and acid from which the ester was data base on toxicity and exposure and the body’s ability to metabolize formed. For example in the case of ethyl unless EPA determines based on reliable lactic acid, n-propyl ester, (S) to n- lactate, the breakdown products would data that a different margin of safety propyl alcohol and lactic acid, which be ethyl alcohol (ethanol) and lactic will be safe for infants and children. are well-absorbed and metabolized by acid, and in the case of n-propyl-lactate, Due to the expected low oral toxicity of the human body, a qualitative this would be n-propyl alcohol (1- lactic acid, n-propyl ester, (S), a safety assessment for all pathways of human propanol) and lactic acid. The factor analysis has not been used to exposure (food, drinking water, and metabolism of lactic acid is well assess its risk. For the same reasons, the residential) is appropriate. understood; it is an intermediate in additional tenfold safety factor for the human metabolism of glucose. The VI. Cumulative Effects protection of infants and children is unnecessary. World Health Organization (WHO) has Section 408(b)(2)(D)(v) of the FFDCA examined the metabolism of 1-propanol, requires that, when considering whether VIII. Determination of Safety for U.S. and has determined that it is rapidly to establish, modify, or revoke a Population, Infants and Children absorbed and distributed throughout the tolerance, the Agency consider body following ingestion. ‘‘available information’’ concerning the Lactic acid, n-propyl ester, (S) belongs to the same class of lactate esters as V. Aggregate Exposures cumulative effects of a particular pesticide’s residues and ‘‘other lactic acid, ethyl ester, and lactic acid, In examining aggregate exposure, substances that have a common n-butyl ester. The hydrolysis products section 408 of the FFDCA directs EPA mechanism of toxicity.’’ of lactic acid, n-propyl ester, (S) are n- to consider available information Lactic acid, n-propyl ester, (S) is propanol and lactic acid which are concerning exposures from the pesticide structurally related to lactic acid, ethyl readily metabolized by the human body. residue in food and all other non- ester and lactic acid, n-butyl ester. All The SAR assessment did not identify occupational exposures, including are lower toxicity chemicals; therefore, any concerns for carcinogenicity or drinking water from ground water or the resultant risks separately and/or developmental toxicity. EPA concludes surface water and exposure through combined should also be low. These that lactic acid, n-propyl ester, (S) does pesticide use in gardens, lawns, or chemicals do not appear to produce a not pose a dietary risk under reasonably buildings (residential and other indoor toxic metabolite produced by other foreseeable circumstances, and that uses). substances. For the purposes of this there is a reasonable certainty of no As previously stated, lactic acid, n- tolerance action, therefore, EPA has not harm from aggregate exposure to propyl ester, (S) belongs to the same assumed that these chemical substances residues of lactic acid, n-propyl ester, class of lactate esters as lactic acid, ethyl have a common mechanism of toxicity (S). ester, and lactic acid, n-butyl ester. The with other substances. For information IX. Other Considerations SAR assessments for each of these three regarding EPA’s efforts to determine chemicals supports the conclusion that which chemicals have a common A. Endocrine Disruptors as a class, lactate esters, including lactic mechanism of toxicity and to evaluate acid, n-propyl ester, (S) are of low the cumulative effects of such FQPA requires EPA to develop a toxicity. chemicals, see the policy statements screening program to determine whether Given their physical/chemical released by EPA’s Office of Pesticide certain substances, including all properties, lactate esters could have a Programs concerning common pesticide chemicals (both inert and variety of uses in and around the home. mechanism determinations and active ingredients), may have an effect According to information on the procedures for cumulating effects from in humans that is similar to an effect Internet they are being considered as substances found to have a common produced by a naturally occurring ‘‘green’’ replacements for many of the mechanism on EPA’s website at http:// estrogen, or such other endocrine effect. organic solvents traditionally used in www.epa.gov/pesticides/cumulative/. EPA has been working with interested the manufacturing industry. The Agency stakeholders to develop a screening and has estimated a generic dietary exposure VII. Safety Factor for Infants and testing program as well as a priority estimate for an inert ingredient of 0.12 Children setting scheme. As the Agency proceeds milligrams/kilogram/day (mg/kg/day). Section 408 of FFDCA provides that with implementation of this program, To assure that the exposure is not EPA shall apply an additional tenfold further testing of products containing

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lactic acid, n-propyl ester, (S) for FFDCA by the FQPA, EPA will continue must mail the fee to: EPA Headquarters endocrine effects may be required. to use those procedures, with Accounting Operations Branch, Office appropriate adjustments, until the of Pesticide Programs, P.O. Box B. Analytical Method(s) necessary modifications can be made. 360277M, Pittsburgh, PA 15251. Please An analytical method is not required The new section 408(g) of the FFDCA identify the fee submission by labeling for enforcement purposes since the provides essentially the same process it ‘‘Tolerance Petition Fees.’’ Agency is establishing an exemption for persons to ‘‘object’’ to a regulation EPA is authorized to waive any fee from the requirement of a tolerance for an exemption from the requirement requirement ‘‘when in the judgement of without any numerical limitation. of a tolerance issued by EPA under new the Administrator such a waiver or section 408(d) of the FFDCA, as was refund is equitable and not contrary to C. Existing Exemptions provided in the old FFDCA sections 408 the purpose of this subsection.’’ For There are no existing tolerances or and 409 of the FFDCA. However, the additional information regarding the tolerance exemptions for lactic acid, n- period for filing objections is now 60 waiver of these fees, you may contact propyl ester, (S). days, rather than 30 days. James Tompkins by phone at (703) 305– D. International Tolerances 5697, by e-mail at A. What Do I Need to Do to File an [email protected], or by mailing a The Agency is not aware of any Objection or Request a Hearing? request for information to Mr. Tompkins country requiring a tolerance for lactic You must file your objection or at Registration Division (7505C), Office acid, n-propyl ester, (S) nor have any request a hearing on this regulation in of Pesticide Programs, Environmental CODEX maximum residue levels been accordance with the instructions Protection Agency, 1200 Pennsylvania established for any food crops at this provided in this unit and in 40 CFR part Ave., NW., Washington, DC 20460– time. 178. To ensure proper receipt by EPA, 0001. you must identify docket ID number If you would like to request a waiver E. List 4B Classification OPP–2004–0040 in the subject line on of the tolerance objection fees, you must It has been determined that lactic the first page of your submission. All mail your request for such a waiver to: acid, n-propyl ester, (S) is to be requests must be in writing, and must be James Hollins, Information Resources classified as a List 4B inert ingredient. mailed or delivered to the Hearing Clerk and Services Division (7502C), Office of This classification is due to the Toxicity on or before August 23, 2004. Pesticide Programs, Environmental Category I determination for the acute 1. Filing the request. Your objection Protection Agency, 1200 Pennsylvania eye irritation study. Tolerance must specify the specific provisions in Ave., NW., Washington, DC 20460– exemptions for lactic acid, n-propyl the regulation that you object to, and the 0001. ester, (S) will be established in 40 CFR grounds for the objections (40 CFR 3. Copies for the Docket. In addition 180.910 and 180.930 instead of 40 CFR 178.25). If a hearing is requested, the to filing an objection or hearing request 180.950 as requested by the petitioner objections must include a statement of with the Hearing Clerk as described in PURAC. the factual issues(s) on which a hearing Unit XI.A., you should also send a copy is requested, the requestor’s contentions of your request to the PIRIB for its X. Conclusions on such issues, and a summary of any inclusion in the official record that is Based on the Agency’s review and evidence relied upon by the objector (40 described in ADDRESSES. Mail your evaluation of information on the toxicity CFR 178.27). Information submitted in copies, identified by docket ID number of lactic acid, n-propyl ester, (S) as connection with an objection or hearing OPP–2004–0040, to: Public Information summarized in this preamble, and the request may be claimed confidential by and Records Integrity Branch, previous evaluation of the structurally- marking any part or all of that Information Resources and Services related chemicals, lactic acid, ethyl ester information as CBI. Information so Division (7502C), Office of Pesticide and lactic acid, n-butyl ester (see the marked will not be disclosed except in Programs, Environmental Protection September 3, 2002 Final Rule), and accordance with procedures set forth in Agency, 1200 Pennsylvania Ave., NW., considering the SAR assessments, and 40 CFR part 2. A copy of the Washington, DC 20460–0001. In person an understanding of the metabolism of information that does not contain CBI or by courier, bring a copy to the lactate esters as a chemical class, EPA must be submitted for inclusion in the location of the PIRIB described in concludes that there is a reasonable public record. Information not marked ADDRESSES. You may also send an certainty of no harm from aggregate confidential may be disclosed publicly electronic copy of your request via e- exposure to residues of lactic acid, n- by EPA without prior notice. mail to: [email protected]. Please use propyl ester, (S). Accordingly, EPA Mail your written request to: Office of an ASCII file format and avoid the use finds that exempting lactic acid, n- the Hearing Clerk (1900L), of special characters and any form of propyl ester, (CAS Reg. No. 53651–69– Environmental Protection Agency, 1200 encryption. Copies of electronic 7) from the requirement of a tolerance Pennsylvania Ave., NW., Washington, objections and hearing requests will also will be safe. DC 20460–0001. You may also deliver be accepted on disks in WordPerfect your request to the Office of the Hearing XI. Objections and Hearing Requests 6.1/8.0 or ASCII file format. Do not Clerk in Suite 350, 1099 14th St., NW., include any CBI in your electronic copy. Under section 408(g) of the FFDCA, as Washington, DC 20005. The Office of You may also submit an electronic copy amended by the FQPA, any person may the Hearing Clerk is open from 8 a.m. of your request at many Federal file an objection to any aspect of this to 4 p.m., Monday through Friday, Depository Libraries. regulation and may also request a excluding legal holidays. The telephone hearing on those objections. The EPA number for the Office of the Hearing B. When Will the Agency Grant a procedural regulations which govern the Clerk is (202) 564–6255. Request for a Hearing? submission of objections and requests 2. Tolerance fee payment. If you file A request for a hearing will be granted for hearings appear in 40 CFR part 178. an objection or request a hearing, you if the Administrator determines that the Although the procedures in those must also pay the fee prescribed by 40 material submitted shows the following: regulations require some modification to CFR 180.33(i) or request a waiver of that There is a genuine and substantial issue reflect the amendments made to the fee pursuant to 40 CFR 180.33(m). You of fact; there is a reasonable possibility

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that available evidence identified by the government and the States, or on the copy of the rule, to each House of the requestor would, if established resolve distribution of power and Congress and to the Comptroller General one or more of such issues in favor of responsibilities among the various of the United States. EPA will submit a the requestor, taking into account levels of government, as specified in report containing this rule and other uncontested claims or facts to the Executive Order 13132, entitled required information to the U.S. Senate, contrary; and resolution of the factual Federalism (64 FR 43255, August 10, the U.S. House of Representatives, and issues(s) in the manner sought by the 1999). Executive Order 13132 requires the Comptroller General of the United requestor would be adequate to justify EPA to develop an accountable process States prior to publication of this final the action requested (40 CFR 178.32). to ensure ‘‘meaningful and timely input rule in the Federal Register. This final by State and local officials in the XII. Statutory and Executive Order rule is not a ‘‘major rule’’ as defined by development of regulatory policies that Reviews 5 U.S.C. 804(2). have federalism implications.’’ ‘‘Policies This final rule establishes an that have federalism implications’’ is List of Subjects in 40 CFR Part 180 exemption from the tolerance defined in the Executive Order to Environmental protection, requirement under section 408(d) of the include regulations that have Administrative practice and procedure, FFDCA in response to a petition ‘‘substantial direct effects on the States, Agricultural commodities, Pesticides submitted to the Agency. The Office of on the relationship between the national and pests, Reporting and recordkeeping Management and Budget (OMB) has government and the States, or on the requirements. exempted these types of actions from distribution of power and Dated: June 9, 2004. review under Executive Order 12866, responsibilities among the various entitled Regulatory Planning and levels of government.’’ This final rule Lois Rossi, Review (58 FR 51735, October 4, 1993). directly regulates growers, food Director, Registration Division, Office of Because this rule has been exempted processors, food handlers and food Pesticide Programs. from review under Executive Order retailers, not States. This action does not I Therefore, 40 CFR chapter I is 12866 due to its lack of significance, alter the relationships or distribution of amended as follows: this rule is not subject to Executive power and responsibilities established Order 13211, Actions Concerning by Congress in the preemption PART 180—[AMENDED] Regulations That Significantly Affect provisions of section 408(n)(4) of the I Energy Supply, Distribution, or Use (66 FFDCA. For these same reasons, the 1. The authority citation for part 180 FR 28355, May 22, 2001). This final rule Agency has determined that this rule continues to read as follows: does not contain any information does not have any ‘‘tribal implications’’ Authority: 21 U.S.C. 321(q), 346a and 371. collections subject to OMB approval as described in Executive Order 13175, under the Paperwork Reduction Act entitled Consultation and Coordination I 2. In § 180.910, the table is amended by (PRA), 44 U.S.C. 3501 et seq., or impose with Indian Tribal Governments (65 FR adding alphabetically the following inert any enforceable duty or contain any 67249, November 6, 2000). Executive ingredient to read as follows: unfunded mandate as described under Order 13175, requires EPA to develop § 180.910 Inert ingredients used pre- and Title II of the Unfunded Mandates an accountable process to ensure post-harvest; exemptions from the Reform Act of 1995 (UMRA) (Public ‘‘meaningful and timely input by tribal requirement of a tolerance. Law 104–4). Nor does it require any officials in the development of * * * * * special considerations under Executive regulatory policies that have tribal Order 12898, entitled Federal Actions to implications.’’ ‘‘Policies that have tribal Inert Ingredients Limits Uses Address Environmental Justice in implications’’ is defined in the Minority Populations and Low-Income Executive Order to include regulations *** * * Populations (59 FR 7629, February 16, that have ‘‘substantial direct effects on 1994); or OMB review or any Agency one or more Indian tribes, on the Lactic acid, n- ...... Solvent action under Executive Order 13045, relationship between the Federal propyl ester, entitled Protection of Children from Government and the Indian tribes, or on (S); (CAS Environmental Health Risks and Safety the distribution of power and Reg. No. Risks (62 FR 19885, April 23, 1997). 53651–69–7). responsibilities between the Federal *** * * This action does not involve any Government and Indian tribes.’’ This technical standards that would require rule will not have substantial direct Agency consideration of voluntary effects on tribal governments, on the consensus standards pursuant to section relationship between the Federal I 3. In § 180.930, the table is amended by 12(d) of the National Technology Government and Indian tribes, or on the adding alphabetically the following inert Transfer and Advancement Act of 1995 distribution of power and ingredient to read as follows: (NTTAA), Public Law 104–113, section responsibilities between the Federal 12(d) (15 U.S.C. 272 note). Since Government and Indian tribes, as § 180.930 Inert ingredients applied to tolerances and exemptions that are specified in Executive Order 13175. animals; exemptions from the requirement of a tolerance. established on the basis of a petition Thus, Executive Order 13175 does not under section 408(d) of the FFDCA, apply to this rule. * * * * * such as the exemption in this final rule, do not require the issuance of a XIII. Congressional Review Act Inert Ingredients Limits Uses proposed rule, the requirements of the The Congressional Review Act, 5 *** * * Regulatory Flexibility Act (RFA) (5 U.S.C. 801 et seq., as added by the Small U.S.C. 601 et seq.) do not apply. In Business Regulatory Enforcement Lactic acid, n- ...... Solvent addition, the Agency has determined Fairness Act of 1996, generally provides propyl ester, that this action will not have a that before a rule may take effect, the (S); (CAS substantial direct effect on States, on the agency promulgating the rule must Reg. No. relationship between the national submit a rule report, which includes a 53651–69–7).

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Inert Ingredients Limits Uses FEDERAL COMMUNICATIONS 202–418–0217, or via the Internet at COMMISSION [email protected]. *** * * SUPPLEMENTARY INFORMATION: This is a 47 CFR Part 64 summary of the Media Bureau’s Third Report and Order (‘‘3R&O’’) in MM [FR Doc. 04–14221 Filed 6–22–04; 8:45 am] Miscellaneous Rules Relating to Common Carriers Docket No. 98–204; FCC 04–103, BILLING CODE 6560–50–S adopted April 19, 2004, and released on CFR Correction June 4, 2004. The full text of this 3R&O is available for inspection and copying In Title 47 of the Code of Federal during regular business hours in the Regulations, parts 40 to 69, revised as of FEDERAL COMMUNICATIONS FCC Reference Center, 445 Twelfth October 1, 2003, on page 329, § 64.2400 COMMISSION Street, SW., Room CY–A257, Portals II, paragraph (b) is corrected by removing Washington, DC, 20554, and may also ‘‘64.2001(a)(2), 64.2001(b), and 47 CFR Part 25 be purchased from the Commission’s 64.2001(c)’’, and adding in its place copy contractor, Best Copy and Printing, ‘‘64.2401(a)(2), 64.2401(b), and Inc., Room CY–B402, telephone (800) [MM Docket No. 93–25; FCC 04–44] 64.2401(c)’’. 378–3160, e-mail http:// RIN 3060–AF39 [FR Doc. 04–55512 Filed 6–22–04; 8:45 am] www.BCPIWEB.com. This document is BILLING CODE 1505–01–D available in alternative formats Implementation of the Cable Television (computer diskette, large print, audio Consumer Protection and Competition cassette and Braille). Persons who need Act of 1992; Direct Broadcast Satellite FEDERAL COMMUNICATIONS documents in such formats may send an Public Interest Obligations COMMISSION e-mail to [email protected] or call the Consumer & Governmental Affairs 47 CFR Parts 73 and 76 AGENCY: Federal Communications Bureau at 202–418–0531 (voice), 418– 7365 (tty). Commission. [MM Docket No. 98–204; FCC 04–103] ACTION: Correcting amendments. Synopsis of Third Report and Order RIN 3060–AH95 I. Background SUMMARY: The Commission is correcting Review of the Commission’s 1. The Second Notice of Proposed a final rule that appeared in the Federal Broadcast and Cable Equal Rulemaking (‘‘2NPRM’’), 67 FR 1704, Register of April 28, 2004 (69 FR Employment Opportunity Rules and January 14, 2002, in this proceeding 23155). This document corrects Policies proposed and requested comment on typographical errors in the effective date new broadcast station and multichannel AGENCY: and in the preamble. The corrected Federal Communications video programming distributor effective date appears below. Commission. (‘‘MVPD’’) Equal Employment ACTION: Final rule. DATES: The rule published at 69 FR Opportunity (‘‘EEO’’) rules and new annual employment report forms to 23155 is effective May 28, 2004, except SUMMARY: In this document, the collect data on the race, ethnicity, and for §§ 25.701(d)(1)(i), 25.701(d)(1)(ii), Commission adopts new broadcast and gender of the workforce of broadcast 25.701(d)(2), 25.701(d)(3), 25.701(e)(3), multichannel video programming and MVPD employment units. In the 25.701 (f)(6)(i), and 25.701(f)(6)(ii) distributor (‘‘MVPD’’) equal Second Report and Order (‘‘2R&O’’), 68 which contain information collection employment opportunity (‘‘EEO’’) rules. FR 670, January 7, 2003, and Third requirements that have not been The Commission revised Forms 395–A Notice of Proposed Rulemaking approved by OMB. The Federal and 395–B but issued a notice of (‘‘3NPRM’’), 67 FR 77374, December 17, proposed rulemaking on issues Communications Commission will 2002, in this proceeding, we adopted regarding whether to keep annual publish a document in the Federal new broadcast and MVPD EEO rules, employment reports confidential or Register announcing the effective date. but deferred action on the issues partially confidential. FOR FURTHER INFORMATION CONTACT: relating to the Annual Employment DATES: Rosalee Chiara, Federal Sections 73.3612 and 76.1802 Report forms. We now address those Communications Commission, Policy contain information collection issues and adopt revised FCC Form requirements that have not been Division, Media Bureau, 445 12th St., 395–B, the broadcast station Annual approved by the Office of Management Washington, DC 20554, (202) 418–0754. Employment Report, and FCC Form and Budget (OMB). The Commission 395–A, the multichannel video SUPPLEMENTARY INFORMATION: In FR Doc. will publish a document in the Federal programming distributor Annual 04–9170 appearing on page 23155 in the Register announcing the effective date Employment Report. We also seek issue of April 28, 2004, the effective of these rules. Written comments by the comment in the Fourth Notice of date is corrected as set forth above, and public on the modified information Proposed Rulemaking (‘‘4NPRM’’) on in paragraph 18 of the preamble, the collection requirements are due August the Commission’s policies regarding references to §§ 75.701(d)(2) and 23, 2004. public access to data contained in FCC 75.701(d)(3) are corrected to read FOR FURTHER INFORMATION CONTACT: Forms 395–A and 395–B. ‘‘25.701(d)(2)’’ and ‘‘25.701(d)(3)’’. Lewis Pulley, Policy Division, Media 2. In previously deferring action with Federal Communications Commission. Bureau, (202) 418–1450 or respect to FCC Forms 395–A and [email protected]. For additional 395–B, we stated that a deferral would Marlene H. Dortch, information concerning the Paperwork permit us to coordinate these forms with Secretary. Reduction Act information collection new standards for classifying data on [FR Doc. 04–14263 Filed 6–22–04; 8:45 am] requirements contained in this race, ethnicity, and job categories BILLING CODE 6712–01–P document, contact Leslie F. Smith at adopted by the Office of Management

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