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within a 6.8-mile radius of the airport September 15, 2016, is amended as APAAN would be regulated pursuant to would be established for IFR operations. follows: the Controlled Substances Act. Class E airspace designations are Paragraph 6005 Class E Airspace Areas DATES: Electronic comments must be published in Paragraph 6005 of FAA Extending Upward From 700 Feet or More submitted, and written comments must Order 7400.11A, dated August 3, 2016, Above the Surface of the Earth. be postmarked, on or before January 11, and effective September 15, 2016, which * * * * * 2017. Commenters should be aware that is incorporated by reference in 14 CFR the electronic Federal Docket 71.1. The Class E airspace designation ASO GA E5 Louisville, GA [New] Management System will not accept listed in this document will be Louisville Municipal Airport, GA comments after 11:59 p.m. Eastern Time published subsequently in the Order. (Lat. 32°59′09″ N., long. 82°23′05″ W.) on the last day of the comment period. That airspace extending upward from 700 Regulatory Notices and Analyses ADDRESSES: To ensure proper handling feet above the surface within a 6.8-mile of comments, please reference ‘‘Docket The FAA has determined that this radius of Louisville Municipal Airport. No. DEA–379’’ on all correspondence, proposed regulation only involves an Issued in College Park, Georgia, on including any attachments. established body of technical November 30, 2016. The Drug Enforcement regulations for which frequent and Ryan W. Almasy, Administration encourages that all routine amendments are necessary to Manager, Operations Support Group, Eastern comments be submitted electronically keep them operationally current. It, Service Center, Air Traffic Organization. through the Federal eRulemaking Portal, therefore: (1) Is not a ‘‘significant [FR Doc. 2016–29631 Filed 12–9–16; 8:45 am] which provides the ability to type short regulatory action’’ under Executive BILLING CODE 4910–13–P comments directly into the comment Order 12866; (2) is not a ‘‘significant field on the Web page or to attach a file rule’’ under DOT Regulatory Policies for lengthier comments. Please go to and Procedures (44 FR 11034; February http://www.regulations.gov/ and follow 26, 1979); and (3) does not warrant DEPARTMENT OF JUSTICE the online instructions at that site for preparation of a Regulatory Evaluation submitting comments. Upon completion Drug Enforcement Administration as the anticipated impact is so minimal. of your submission, you will receive a Since this is a routine matter that will Comment Tracking Number for your 21 CFR Part 1310 only affect air traffic procedures and air comment. Please be aware that navigation, it is certified that this [Docket No. DEA–379] submitted comments are not proposed rule, when promulgated, will instantaneously available for public not have a significant economic impact RIN 1117–ZA04 view on Regulations.gov. If you have on a substantial number of small entities received a Comment Tracking Number, under the criteria of the Regulatory Designation of Alpha- your comment has been successfully Flexibility Act. Phenylacetoacetonitrile (APAAN), a submitted and there is no need to Precursor Chemical Used in the Illicit resubmit the same comment. Paper Environmental Review Manufacture of Phenylacetone, comments that duplicate the electronic This proposal would be subject to an Methamphetamine, and Amphetamine, submission are not necessary and are environmental analysis in accordance as a List I Chemical discouraged. Should you wish to mail a with FAA Order 1050.1F, AGENCY: Drug Enforcement paper comment in lieu of an electronic ‘‘Environmental Impacts: Policies and Administration, Department of Justice. comment, it should be sent via regular Procedures’’ prior to any FAA final or express mail to: Drug Enforcement ACTION: Notice of proposed rulemaking. regulatory action. Administration, Attn: DEA Federal Lists of Subjects in 14 CFR Part 71 SUMMARY: The Drug Enforcement Register Representative/ODW, 8701 Administration is proposing to Morrissette Drive, Springfield, Virginia Airspace, Incorporation by reference, designate the chemical alpha- 22152. Navigation (air). phenylacetoacetonitrile (APAAN) and FOR FURTHER INFORMATION CONTACT: The Proposed Amendment its salts, optical isomers, and salts of Michael J. Lewis, Office of Diversion optical isomers, as a list I chemical In consideration of the foregoing, the Control, Drug Enforcement under the Controlled Substances Act. Federal Aviation Administration Administration; Mailing Address: 8701 APAAN is used in clandestine proposes to amend 14 CFR part 71 as Morrissette Drive, Springfield, Virginia laboratories to illicitly manufacture the follows: 22152; Telephone: (202) 598–6812. schedule II controlled substances SUPPLEMENTARY INFORMATION: phenylacetone (also known as phenyl-2- PART 71—DESIGNATION OF CLASS A, Posting of Public Comments B, C, D, AND E AIRSPACE AREAS; AIR propanone or P2P), methamphetamine, TRAFFIC SERVICE ROUTES; AND and amphetamine and is important to Please note that all comments REPORTING POINTS the manufacture of these controlled received are considered part of the substances. This action does not public record. They will, unless ■ 1. The authority citation for Part 71 propose the establishment of a threshold reasonable cause is given, be made continues to read as follows: for domestic and international available by the Drug Enforcement Authority: 49 U.S.C. 106(f), 106(g); 40103, transactions of APAAN. As such, all Administration (DEA) for public 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, transactions involving APAAN, inspection online at http:// 1959–1963 Comp., p. 389. regardless of size, would be regulated. www.regulations.gov. Such information In addition, this action proposes that includes personal identifying § 71.1 [Amended] chemical mixtures containing APAAN information (such as name, address, ■ 2. The incorporation by reference in would not be exempt from regulatory etc.) voluntarily submitted by the 14 CFR 71.1 of FAA Order 7400.11A, requirements at any concentration. commenter. The Freedom of Airspace Designations and Reporting Therefore, all transactions of chemical Information Act (FOIA) applies to all Points, dated August 3, 2016, effective mixtures containing any quantity of comments received. If you want to

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submit personal identifying information controlled to protect the public health known as phenyl-2-propanone (P2P) or (such as your name, address, etc.) as and safety. benzyl methyl ketone), part of your comment, but do not want The CSA gives the Attorney General methamphetamine, and amphetamine. it to be made publicly available, you the authority to specify, by regulation, Throughout the 1970s, must include the phrase ‘‘PERSONAL chemicals as list I or list II chemicals. methamphetamine was illicitly IDENTIFYING INFORMATION’’ in the 21 U.S.C. 802(34) and (35). A ‘‘list I produced in the United States, primarily first paragraph of your comment. You chemical’’ is a chemical that is used in with the precursor chemical P2P. In must also place all of the personal manufacturing a controlled substance in response to the illicit use of P2P, the identifying information you do not want violation of title II of the CSA and is DEA controlled P2P as a schedule II made publicly available in the first important to the manufacture of the controlled substance in 1980 pursuant paragraph of your comment and identify controlled substance. 21 U.S.C. 802(34). to the ‘‘immediate precursor’’ provisions what information you want redacted. A ‘‘list II chemical’’ is a chemical (other of the CSA, specifically 21 U.S.C. If you want to submit confidential than a list I chemical) that is used in 811(e). Clandestine laboratory operators business information as part of your manufacturing a controlled substance in responded by developing a variety of comment, but do not want it to be made violation of title II of the CSA. 21 U.S.C. synthetic methods for producing P2P. publicly available, you must include the 802(35). The current list of all listed chemicals is published at 21 CFR Congress and the DEA responded phrase ‘‘CONFIDENTIAL BUSINESS with the implementation of controls on INFORMATION’’ in the first paragraph 1310.02. Pursuant to 28 CFR 0.100(b), the Attorney General has delegated her P2P precursor chemicals such as of your comment. You must also phenylacetic acid (and its salts and prominently identify confidential authority to designate list I and list II chemicals to the Administrator of the esters), acetic anhydride, benzyl business information to be redacted cyanide, benzaldehyde, and nitroethane, within the comment. Drug Enforcement Administration. In addition, the United States is a all of which are controlled as listed Comments containing personal Party to the 1988 United Nations chemicals. 21 CFR 1310.02 (a)–(b). identifying information and confidential Convention against Illicit Traffic in However, clandestine laboratory business information identified as Narcotic Drugs and Psychotropic operators soon adjusted to these directed above will generally be made Substances (1988 Convention). When controls on P2P (and its precursors). As publicly available in redacted form. If a the United States receives notification an alternative for methamphetamine comment has so much confidential that a chemical has been added to Table production, clandestine laboratory business information or personal I or Table II of the 1988 Convention operators used the precursors ephedrine identifying information that it cannot be pursuant to article 12, the United States and pseudoephedrine, and as an effectively redacted, all or part of that is required to take measures it deems alternative for amphetamine production, comment may not be made publicly appropriate to monitor the manufacture they used the precursor available. Comments posted to http:// and distribution of that chemical within phenylpropanolamine. www.regulations.gov may include any the United States and to prevent its personal identifying information (such This led Congress and the DEA to diversion. In addition, the 1988 implement stringent controls on the as name, address, and phone number) Convention requires the United States to manufacture, distribution, importation, included in the text of your electronic take other specified measures related to and exportation of ephedrine (its salts, submission that is not identified as that chemical, including measures optical isomers, and salts of optical directed above as confidential. related to its international trade. An electronic copy of this proposed isomers), pseudoephedrine, and rule is available at http:// Background phenylpropanolamine (controlled as list www.regulations.gov for easy reference. By a letter dated April 9, 2014, the I chemicals), and pharmaceutical Secretary-General of the United Nations products containing these chemicals. Legal Authority informed the United States Government The international community soon took The DEA implements and enforces that the chemical alpha- similar measures. titles II and III of the Comprehensive phenylacetoacetonitrile (APAAN) was With the growing problem of illicit Drug Abuse Prevention and Control Act added to Table I of the 1988 drug production, the issue of precursor of 1970, as amended. 21 U.S.C. 801–971. Convention. This letter was prompted chemical control has gained global Titles II and III are referred to as the by a March 19, 2014, decision at the attention. International efforts to ‘‘Controlled Substances Act’’ and the 57th Session of the United Nations prevent the illicit production of ‘‘Controlled Substances Import and Commission on Narcotic Drugs (CND) to amphetamine-type stimulants Export Act,’’ respectively, and are add APAAN to Table I. As a Party to the (including amphetamine and collectively referred to as the 1988 Convention, the United States is methamphetamine), and international ‘‘Controlled Substances Act’’ or the obligated, pursuant to article 12, to take control of precursors, have made ‘‘CSA’’ for the purpose of this action. measures it deems appropriate to significant progress. International The DEA publishes the implementing monitor the manufacture and controls on precursors were established regulations for these statutes in title 21 distribution of APAAN within the under article 12 of the 1988 of the Code of Federal Regulations United States and to prevent its Convention.1 The 1988 Convention (CFR), chapter II. The CSA and its diversion. Article 12 also obligates the established two categories of controlled implementing regulations are designed United States to take other specified illicit drug precursor substances: Table to prevent, detect, and eliminate the measures related to APAAN, including I and Table II.2 Two international diversion of controlled substances and measures related to its international entities have played a crucial role in listed chemicals into the illicit market trade. By designating APAAN as a list this effort: The United Nations while providing for the legitimate I chemical, the United States will fulfill Commission on Narcotic Drugs (CND) medical, scientific, research, and its obligations under the 1988 industrial needs of the United States. Convention. 1 Dec. 20, 1988, 1582 U.N.T.S. 95. Controlled substances have the potential APAAN is a primary precursor for the 2 Table I and Table II are annexed to the for abuse and dependence and are manufacture of phenylacetone (also Convention.

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and the International Narcotics Control identified 34 potential suppliers in each regulated bulk manufacturer shall Board. China, 6 potential suppliers in the submit manufacturing, inventory, and In response to domestic and United States, 2 in Russia, and 1 each use data on an annual basis. international controls on amphetamine in Bulgaria, Cameroon, the Czech Chemical Mixtures of APAAN and methamphetamine precursors, Republic, France, and Germany. clandestine laboratory operators have The DEA is concerned about the ease This rulemaking also proposes that continued to explore alternate methods with which APAAN serves as a chemical mixtures containing APAAN of making these illicit drugs, including precursor chemical for illicit controlled would not be exempt from regulatory developing techniques to manufacture substance production and with the requirements at any concentration their own precursors and diverting other international trafficking in this unless an application for exemption of precursors to produce these precursors. chemical. The international community a chemical mixture is submitted by an This has led clandestine laboratory echoes this concern. As noted above, the APAAN manufacturer and the operators to utilize the P2P precursor CND has added APAAN to Table I of the application is reviewed and accepted APAAN. Clandestine laboratory 1988 Convention. Therefore, the DEA is and the mixture exempted by the DEA operators currently use APAAN to proposing the designation of APAAN as under 21 CFR 1310.13 (Exemption by manufacture P2P, which they then a list I chemical. Application Process). Since even a small convert to methamphetamine and amount of APAAN yields a significant Proposed Designation of APAAN and amphetamine. amount of P2P, the DEA believes that Its Salts, Optical Isomers, and Salts of regulation of chemical mixtures APAAN Optical Isomers as a List I Chemical containing any amount of APAAN is APAAN also goes by the names: 1- The CSA, specifically 21 U.S.C. necessary to prevent the illicit cyano-1-phenylpropan-2-one; 2- 802(34), and its implementing extraction, isolation, and use of the phenylacetoacetonitrile; 2-acetyl-2- regulations at 21 CFR 1310.02(c), APAAN. Therefore, all chemical phenylacetonitrile; alpha-acetyl- provides the Attorney General with the mixtures containing any quantity of benzene acetonitrile; phenyl aceto- authority to specify, by regulation, a APAAN would be subject to CSA acetonitrile; a-acetylphenylacetonitrile; chemical as a ‘‘list I chemical’’ if the control, unless the APAAN 3-oxo-2-phenylbutanenitrile; CAS chemical is used in the manufacture of manufacturer is granted an exemption Number: 4468–48–8; and Identification a controlled substance in violation of by the application process in Number: UN3439. the CSA and is important to the accordance with 21 CFR 1310.13. This The DEA has long been aware of manufacture of these controlled rule proposes the modification of the APAAN’s potential illicit use as a substances. Clandestine laboratory ‘‘Table of Concentration Limits’’ in 21 primary precursor for the production of operators are using APAAN as the CFR 1310.12(c) to reflect the fact that P2P. The synthesis of P2P from benzyl precursor material for the illicit chemical mixtures containing any cyanide involves the manufacture of manufacture of P2P, methamphetamine, amount of APAAN are subject to CSA APAAN prior to the final synthesis of and amphetamine. These three chemical control provisions. P2P. Therefore, benzyl cyanide and substances are all controlled substances APAAN share the same synthetic under the CSA. APAAN is a primary Exemption by Application Process pathway in the production of P2P. In precursor for P2P, for subsequent The DEA has implemented an the late 1980’s the DEA advocated for conversion to methamphetamine or application process to exempt certain the Congressional control of the P2P amphetamine. Therefore, APAAN is chemical mixtures from the precursor benzyl cyanide as a list I important to the manufacture of a requirements of the CSA and its chemical. controlled substance. This action implementing regulations. 21 CFR Due to the lack of industrial uses of proposes the designation of APAAN as 1310.13. Manufacturers may submit an APAAN, there has historically been a a list I chemical because the DEA finds application for exemption for those lack of available product for potential that APAAN is used in the illicit mixtures that do not qualify for diversion. In recent years, however, manufacture of these controlled automatic exemption. Exemption status large international seizures of APAAN substances and is important to the illicit may be granted if the DEA determines have been made, primarily in Europe, manufacture of these controlled that the mixture is formulated in such which suggest there is a ready supply of substances. a way that it cannot be easily used in APAAN from international chemical If finalized, handlers of APAAN the illicit production of a controlled manufacturers. would become subject to the chemical substance and that the listed chemical While the DEA has encountered one regulatory provisions of the CSA, or chemicals cannot be readily clandestine laboratory in the United including 21 CFR parts 1309, 1310, recovered. 21 CFR 1310.13(a)(1)–(2). States utilizing this synthetic pathway 1313, and 1316. Since even a small in recent years, the DEA’s European amount of APAAN can make a Requirements for Handling List I counterparts have made a large number significant amount of P2P, this action Chemicals of APAAN seizures. For calendar years does not propose the establishment of a If finalized as proposed, the 2009 through 2014, the European threshold for domestic and import designation of APAAN as a list I Commission has documented at least transactions of APAAN in accordance chemical will subject APAAN handlers 113 seizures and stop shipments, with the provisions of 21 CFR (manufacturers, distributors, importers, involving over 80 metric tons of 1310.04(g). Therefore, the DEA is and exporters), and proposed handlers, APAAN. Many of these seizures were proposing that all APAAN transactions, to all of the regulatory controls and associated with seizures of P2P and regardless of size, will be regulated administrative, civil, and criminal amphetamine. Many of these APAAN transactions as defined in 21 CFR actions applicable to the manufacture, seizures originated from chemical 1300.02(b). As such, if finalized, all distribution, importing, and exporting of suppliers based in Asia. APAAN transactions will be subject to a list I chemical. Upon publication of a The DEA has determined that APAAN recordkeeping, reporting, import and final rule, persons potentially handling is now readily available from export controls, and other CSA chemical APAAN, including regulated chemical commercial chemical suppliers and has regulatory requirements. In addition, mixtures containing APAAN, would be

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required to comply with the following requirement for persons desiring to previously furnished to the regulated list I chemical regulations: engage in activities with APAAN, person; any unusual or excessive loss or 1. Registration. Any person who provided that the DEA receives a disappearance of a listed chemical manufactures, distributes, imports, or properly completed application for under the control of the regulated exports APAAN, or proposes to engage registration on or before 30 days after person; any in-transit loss in which the in the manufacture, distribution, publication of a final rule implementing regulated person is the supplier; and importation, or exportation of APAAN, regulations regarding APAAN. The any domestic regulated transaction in a must obtain a registration pursuant to 21 temporary exemption for such persons tableting or encapsulating machine. U.S.C. 822, 823, 957, 958. Regulations will remain in effect until the DEA takes 3. Importation and Exportation. All describing registration for list I chemical final action on their application for importation and exportation of APAAN handlers are set forth in 21 CFR part registration or application for exemption would need to be in compliance with 21 1309. Consistent with 21 CFR parts 1309 of a chemical mixture. U.S.C. 957, 958, and 971 and in and 1310, separate registrations will be The temporary exemption applies accordance with 21 CFR part 1313. required for manufacturing, solely to the registration requirement; 4. Security. All applicants and distribution, importing, and exporting of all other chemical control requirements, registrants would be required to provide APAAN. Different locations operated by including recordkeeping and reporting, effective controls against theft and a single entity require separate would become effective on the effective diversion in accordance with 21 CFR registration if any location is involved date of the final rule. Therefore, all 1309.71–1309.73. with the manufacture, distribution, transactions of APAAN and chemical 5. Administrative Inspection. Places, importation, or exportation of APAAN. mixtures containing APAAN will be including factories, warehouses, or Further, a separate registration is regulated while an application for other establishments and conveyances, required for each principal place of registration or exemption is pending. where registrants or other regulated business at one general physical This is necessary because not regulating persons may lawfully hold, location where list I chemicals are these transactions could result in manufacture, distribute, or otherwise manufactured, distributed, imported, or increased diversion of chemicals dispose of a list I chemical or where exported by a person. 21 CFR 1309.23. desirable to drug traffickers. records relating to those activities are Any person manufacturing, distributing, Additionally, the temporary maintained, are controlled premises as importing, or exporting an APAAN exemption does not suspend applicable defined in 21 U.S.C. 880(a) and 21 CFR chemical mixture will be subject to the federal criminal laws relating to 1316.02(c). The CSA (21 U.S.C. 880) registration requirement under the CSA APAAN, nor does it supersede State or allows for administrative inspections of as well. local laws or regulations. All handlers of these controlled premises as provided in The DEA notes that warehouses are APAAN must comply with applicable 21 CFR part 1316, subpart A. exempt from the requirement of State and local requirements in addition 6. Liability. Any activity involving registration and may lawfully possess to the CSA regulatory controls. APAAN not authorized by, or in list I chemicals, if the possession of 2. Records and Reports. Every DEA violation of, the CSA, would be those chemicals is in the usual course registrant would be required to maintain unlawful, and may subject the person to of business or employment. 21 U.S.C. records and reports with respect to administrative, civil, and/or criminal APAAN pursuant to 21 U.S.C. 830 and 822(c)(2), 21 U.S.C. 957(b)(1)(B). For action. purposes of this exemption, the in accordance with 21 CFR part 1310. warehouse must receive the list I Pursuant to 21 CFR 1310.04, a record Regulatory Analyses must be made and maintained for two chemical from a DEA registrant and Executive Orders 12866 and 13563 shall only distribute the list I chemical years after the date of a transaction back to the DEA registrant and involving a listed chemical, provided This notice of proposed rulemaking, registered location from which it was the transaction is a regulated which proposes the designation of received. All other activities conducted transaction. APAAN as a list I chemical, has been by a warehouse do not fall under this Each regulated bulk manufacturer of a developed in accordance with the exemption; a warehouse that distributes listed chemical will be required to principles of Executive Orders 12866 list I chemicals to persons other than the submit manufacturing, inventory, and and 13563. The DEA followed the registrant and registered location from use data on an annual basis. 21 CFR principles of these Executive Orders, which they were obtained is conducting 1310.05(d). Existing standard industry even though it has been determined that distribution activities and is required to reports containing the required this action is not a significant regulatory register as such. 21 CFR 1309.23(b)(1). information will be acceptable, action. Upon publication of a final rule, any provided the information is separate or To determine whether this action is a person manufacturing, distributing, readily retrievable from the report. significant regulatory action, the DEA importing, or exporting APAAN or a 21 CFR 1310.05(a) requires that each utilized a least cost option analysis. At chemical mixture containing APAAN regulated person shall report to the DEA the outset, the DEA determined that the will become subject to the registration any regulated transaction involving an primary costs of this rule would come requirement under the CSA. The DEA extraordinary quantity of a listed from complying with the registration, recognizes, however, that it is not chemical, an uncommon method of recordkeeping, reporting, and export possible for persons who are subject to payment or delivery, or any other and import requirements set forth in the the registration requirement to circumstance that the regulated person CSA. Therefore, under the least cost immediately complete and submit an believes may indicate that the listed option, an entity would choose to application for registration and for the chemical will be used in violation of the discontinue the sale of APAAN if DEA to immediately issue registrations CSA and its corresponding regulations. proceeds from the sale are less than the for those activities. Therefore, to allow Regulated persons are also required to cost of complying with the rule. continued legitimate commerce in report any proposed regulated The DEA has not identified any APAAN, the DEA is proposing to transaction with a person whose industrial uses of APAAN by domestic establish in 21 CFR 1310.09 a temporary description or other identifying entities and its potential usage appears exemption from the registration characteristics the Administration has to be limited to research. Based on

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independent research following a 2013 responsibilities between the Federal governments, in the aggregate, or by the United Nations Questionnaire/Survey Government and Indian tribes. private sector, of $100,000,000 or more on APAAN, the DEA identified three (adjusted for inflation) in any one year. Regulatory Flexibility Act entities that have each imported Therefore, neither a Small Government APAAN. Two of the three entities had The Acting Administrator, in Agency Plan nor any other action is average annual sales of APAAN totaling accordance with the Regulatory required under provisions of the UMRA $13 during the analysis period. The Flexibility Act (RFA), 5 U.S.C. 601–612, of 1995. third entity had average annual sales of has reviewed this proposed rule and by APAAN totaling $1,440 during the same approving it certifies that it will not Paperwork Reduction Act period. Other chemical distributors list have a significant economic impact on This action does not impose a new APAAN in their chemical catalogs. a substantial number of small entities. collection of information requirement However, these entities do not The purpose of this proposed rule is to under the Paperwork Reduction Act of manufacture APAAN, instead opting to designate APAAN as a list I chemical 1995. 44 U.S.C. 3501–3521. The DEA purchase APAAN from international under the CSA. No less restrictive does not anticipate that it will receive sources to fill special orders. These measures (i.e., non-control or control in new registration applications for the entities do not stock APAAN in list II) would enable the DEA to meet its purpose of engaging in transactions inventory and the vast majority had no statutory obligation under the CSA and involving this chemical. The previous sales of APAAN. its international obligations of the 1988 transactions in this chemical of which The registration fee to import a list I Convention. The DEA estimates that this the DEA is aware are very small, and it chemical is $1,523 per year. Based on rule affects three small entities. As does not appear to the DEA that it the least cost option, these three entities discussed above, the DEA compared the would be economically justifiable would choose to discontinue the sale of dollar value of APAAN sales to the cost because DEA believes there is no APAAN because complying with the of registration. Further, the DEA legitimate market for manufacturing or rule is more costly. Thus, the annual assumed that if the cost of registration engaging in commercial transactions in economic impact of the rule is $1,467 is more than the dollar value of APAAN this chemical. This action would not (total annual sales of APAAN from the sales, then each entity would impose recordkeeping or reporting three affected entities). Therefore, this is discontinue the sale of APAAN. requirements on State or local evidence that this proposed rule would Two entities earned $13 in annual governments, individuals, businesses, or not have an annual effect on the sales of APAAN while the third entity organizations. An agency may not economy of $100 million or more and is earned $1,440 in annual sales of conduct or sponsor, and a person is not not a significant regulatory action. APAAN. The cost of registration alone required to respond to, a collection of Executive Order 12988 is $1,523 for each entity. Therefore, the information unless it displays a DEA anticipates that each entity will This proposed regulation meets the currently valid OMB control number. discontinue the sale of APAAN because applicable standards set forth in the cost of compliance is greater than List of Subjects 21 CFR Part 1310 sections 3(a) and 3(b)(2) of Executive the annual sales. As a result, the annual Order 12988 to eliminate drafting errors Drug traffic control, Exports, Imports, economic impact of the rule is $1,467. and ambiguity, minimize litigation, Reporting and recordkeeping Using 1% of annual revenue as the provide a clear legal standard for requirements. criteria for significant economic impact, affected conduct, and promote Accordingly, for the reasons set forth the DEA estimates that none of the three simplification and burden reduction. in the preamble, part 1310 of title 21 of small entities will experience a the Code of Federal Regulations is Executive Order 13132 significant economic impact if the proposed to be amended as follows: This proposed rulemaking does not proposed rule is finalized. The cost of have federalism implications warranting the rule as a percentage of annual PART 1310—RECORDS AND the application of Executive Order revenue for the three entities is, REPORTS OF LISTED CHEMICALS 13132. The proposed rule does not have 0.00044%, 0.00036%, and 0.038%, AND CERTAIN MACHINES substantial direct effects on the States, respectively, which is less than 1% of on the relationship between the national the entities’ annual income. Therefore, ■ 1. The authority citation for part 1310 government and the States, or the the proposed rule will not have a continues to read as follows: distribution of power and significant effect on a substantial number of small entities. Authority: 21 U.S.C. 802, 827(h), 830, responsibilities among the various 871(b), 890. levels of government. Unfunded Mandates Reform Act of 1995 ■ 2. Amend § 1310.02 by redesignating Executive Order 13175 On the basis of information contained paragraphs (a)(1) through (a)(30) as This proposed rule does not have in the ‘‘Regulatory Flexibility Act’’ paragraphs (a)(2) through (a)(31), tribal implications warranting the section above, the DEA has determined respectively, and adding a new application of Executive Order 13175. It and certifies pursuant to the Unfunded paragraph (a)(1) in the table ‘‘List I does not have substantial direct effects Mandates Reform Act (UMRA) of 1995, chemicals’’ to read as follows: on one or more Indian tribes, on the 2 U.S.C. 1501 et seq., that this action relationship between the Federal would not result in any Federal § 1310.02 Substances covered. Government and Indian tribes, or on the mandate that may result in the * * * * * distribution of power and expenditure by State, local, and tribal (a) * * *

(1) Alpha-phenylacetoacetonitrile and its salts, optical isomers, and salts of optical isomers (APAAN) ...... 8512

* * * * * ■ 3. Amend § 1310.04 by redesignating paragraphs (g)(1)(ii) through (g)(1)(xi), paragraphs (g)(1)(i) through (g)(1)(x) as

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respectively, and adding a new requirement, provided that the DEA exemption is subsequently denied by paragraph (g)(1)(i) to read as follows: receives a properly completed the DEA must obtain a registration with application for registration or the DEA. A temporary exemption from § 1310.04 Maintenance of records. application for exemption for a the registration requirement will also be * * * * * chemical mixture containing alpha- provided for those persons whose (g) * * * phenylacetoacetonitrile (APAAN) and applications for exemption are denied, (1) * * * its salts, optical isomers, and salts of provided that the DEA receives a (i) Alpha-phenylacetoacetonitrile and optical isomers, pursuant to Section properly completed application for its salts, optical isomers, and salts of 1310.13 of this part on or before (30 registration on or before 30 days optical isomers (APAAN) days after publication of a Final Rule following the date of official DEA * * * * * implementing regulations regarding notification that the application for ■ 4. Amend § 1310.09 by adding new APAAN). The exemption will remain in exemption has been denied. The paragraph (n) to read as follows: effect for each person who has made temporary exemption for such persons § 1310.09 Temporary exemption from such application until the will remain in effect until the DEA takes registration. Administration has approved or denied final action on their registration * * * * * that application. This exemption applies application. (n)(1) Each person required under only to registration; all other chemical ■ 5. Amend § 1310.12 paragraph (c) by Sections 302 and 1007 of the Act (21 control requirements set forth in the Act adding in alphabetical order an entry U.S.C. 822, 957) to obtain a registration and parts 1309, 1310, 1313, and 1316 of ‘‘Alpha-phenylacetoacetonitrile, and its to manufacture, distribute, import, or this chapter remain in full force and salts, optical isomers, and salts of export regulated alpha- effect. optical isomers. (APAAN)’’ in the table phenylacetoacetonitrile (APAAN) and (2) Any person who manufactures, ‘‘Table of Concentration Limits’’ to read its salts, optical isomers, and salts of distributes, imports or exports a as follows: optical isomers, including regulated chemical mixture containing alpha- chemical mixtures pursuant to Section phenylacetoacetonitrile (APAAN) and § 1310.12 Exempt chemical mixtures. 1310.12 of this part, is temporarily its salts, optical isomers, and salts of * * * * * exempted from the registration optical isomers whose application for (c) * * *

TABLE OF CONCENTRATION LIMITS

DEA chemical code No. Concentration Special conditions

******* Alpha-phenylacetoacetonitrile, and its salts, optical isomers, 8512 Not exempt at any concentra- Chemical mixtures containing and salts of optical isomers. (APAAN). tion. any amount of APAAN are not exempt.

*******

* * * * * Great Basin Unified Air Pollution NAAQS and for an annual emission Dated: December 2, 2016. Control District (GBUAPCD or reduction in PM10 of not less than five

Chuck Rosenberg, ‘‘District’’) to meet Clean Air Act (CAA percent until attainment of the PM10 or ‘‘Act’’) requirements applicable to the NAAQS. The EPA is proposing to Acting Administrator. Owens Valley PM10 nonattainment area approve the 2016 PM10 Plan as meeting [FR Doc. 2016–29523 Filed 12–9–16; 8:45 am] (NA). The Owens Valley PM10 NA is all relevant statutory and regulatory BILLING CODE 4410–09–P located in the southern portion of the requirements. Owens Valley in Inyo County, DATES: California. It is classified as a Serious Any comments on this proposal ENVIRONMENTAL PROTECTION nonattainment area for the national must arrive by January 11, 2017. AGENCY ambient air quality standards (NAAQS) ADDRESSES: Submit comments, for particulate matter of ten microns or identified by docket number EPA–R09– 40 CFR Part 52 less (PM10). The submitted SIP revision OAR–2016–0660, at http:// [EPA–R09–OAR–2016–0660; FRL–9956–27– is the ‘‘Great Basin Unified Air www.regualtions.gov, or via email to Region 9] Pollution Control District 2016 Owens [email protected]. For comments Valley Planning Area PM State submitted at Regulations.gov, follow the Approval of California Air Plan; Owens 10 Implementation Plan’’ (‘‘2016 PM10 online instructions for submitting Valley Serious Area Plan for the 1987 Plan’’ or ‘‘Plan’’). The GBUAPCD’s comments. Once submitted, comments 24-Hour PM10 Standard obligation to submit the 2016 PM10 Plan cannot be edited or removed from AGENCY: Environmental Protection was triggered by the EPA’s 2007 finding Regulations.gov. For either manner of Agency (EPA). that the Owens Valley PM10 NA had submission, the EPA may publish any ACTION: Proposed rule. failed to meet its December 31, 2006, comment received to its public docket. deadline to attain the PM10 NAAQS. Do not submit electronically any SUMMARY: The Environmental Protection The CAA requires a Serious PM10 information you consider to be Agency (EPA) is proposing to approve a nonattainment area that fails to meet its Confidential Business Information (CBI) state implementation plan (SIP) revision attainment deadline to submit a plan or other information whose disclosure is submitted by the State of California and providing for attainment of the PM10 restricted by statute. Multimedia

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