Source: https://www.federalregister.gov/documents/2017/07/14/2017-14878/designation-of-alpha-phenylacetoacetonitrile-apaan-a-precursor-chemical-used-in-the-illicit
Timestamp: 2017-09-22 05:18:29
Document Index: 326965234

Matched Legal Cases: ['ART 1310', 'arts 1309', '§\u20091310', '§\u20091310', '§\u20091310', '§\u20091310', '§\u20091310', '§\u20091310', 'arts 1309', '§\u20091310']

Federal Register :: Designation of Alpha-Phenylacetoacetonitrile (APAAN), a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical
A Rule by the Drug Enforcement Administration on 07/14/2017
Effective date: August 14, 2017.
82 FR 32457
32457-32461 (5 pages)
Docket No. DEA-379
1117-ZA04
2017-14878
DEA-2016-0019
APAAN_EIA_Final
PART 1310—RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES
https://www.federalregister.gov/d/2017-14878 https://www.federalregister.gov/d/2017-14878
The Drug Enforcement Administration (DEA) is finalizing the designation of the chemical alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, as a list I chemical under the Controlled Substances Act (CSA). The DEA proposed control of APAAN, due to its use in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine. This rulemaking finalizes, without change, the control of APAAN as a list I chemical.
The Controlled Substances Act (CSA) gives the Attorney General the authority to specify, by regulation, chemicals as list I or list II chemicals. 21 U.S.C. 802 (34) and (35). A “list I chemical” is a chemical that is used in manufacturing a controlled substance in violation of title II of the CSA, and is important to the manufacture of the controlled substance. 21 U.S.C. 802(34). A “list II chemical” is a chemical (other than a list I chemical) that is used in manufacturing a controlled substance in violation of title II of the CSA. 21 U.S.C. 802(35). The current list of all listed chemicals is published at 21 CFR 1310.02. Pursuant to 28 CFR 0.100(b), the Attorney General has delegated his authority to designate list I and list II chemicals to the Administrator of the Drug Enforcement Administration.
On the effective date of this final rule, handlers of APAAN shall be subject to the chemical regulatory provisions of the CSA, including 21 CFR parts 1309, 1310, 1313, and 1316. Since even a small amount of APAAN can make a significant amount of P2P, this action does not establish a threshold for domestic and import transactions of APAAN in accordance with the provisions of 21 CFR 1310.04(g). Therefore, all APAAN transactions, regardless of size, will be regulated Start Printed Page 32458transactions as defined in 21 CFR 1300.02(b). As such, all APAAN transactions will be subject to recordkeeping, reporting, import and export controls, and other CSA chemical regulatory requirements. In addition, each regulated bulk manufacturer shall submit manufacturing, inventory, and use data on an annual basis.
Under this final rulemaking, chemical mixtures containing APAAN shall not be exempt from regulatory requirements at any concentration, unless an application for exemption of a chemical mixture is submitted by an APAAN manufacturer, and the application is reviewed and accepted and the mixture exempted by the DEA under 21 CFR 1310.13. Therefore, all chemical mixtures containing any quantity of APAAN shall be subject to CSA control, unless the APAAN manufacturer is granted an exemption by the application process in accordance with 21 CFR 1310.13. This rule modifies the “Table of Concentration Limits” in 21 CFR 1310.12(c) to reflect the fact that chemical mixtures containing any amount of APAAN are subject to CSA chemical control provisions.
The temporary exemption applies solely to the registration requirement; all other chemical control requirements, including recordkeeping and reporting, would become effective on the effective date of this final rule. Therefore, all transactions of APAAN and chemical mixtures containing APAAN will be regulated while an application for registration or exemption is pending. This is necessary because not regulating these transactions could result in increased diversion of chemicals desirable to drug traffickers.
Additionally, the temporary exemption does not suspend applicable federal criminal laws relating to APAAN, nor does it supersede State or local laws or regulations. All handlers of APAAN must comply with applicable State and local requirements in addition to the CSA regulatory controls.
This final rulemaking, which adds APAAN as a list I chemical, has been developed in accordance with the Start Printed Page 32459principles of Executive Orders 12866 and 13563. The DEA followed the principles of these Executive Orders, even though it has been determined that this action is not a significant regulatory action.
Executive Order 13771, titled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017 and published in the Federal Register on February 3, 2017. 82 FR 9339. Section 2(a) of Executive Order 13771 requires an agency, unless prohibited by law, to identify at least two existing regulations to be repealed when the agency publicly proposes for notice and comment or otherwise promulgates a new regulation. In furtherance of this requirement, section 2(c) of Executive Order 13771 requires that the new incremental costs associated with new regulations, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations. The interim guidance from the Office of Management and Budget (OMB), issued on February 2, 2017, explains that for Fiscal Year 2017 the above requirements only apply to each new “significant regulatory action that imposes costs.” Because the DEA has determined that this final rulemaking is not a “significant regulatory action,” the requirements of Executive Order 13771 have not been triggered.
On the basis of information contained in the “Regulatory Flexibility Act” section above, the DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., that this action would not result in any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year. Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of the UMRA of 1995.
This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. The DEA does not anticipate that it will receive new registration applications for the purpose of engaging in transactions involving this chemical. The transactions in this chemical of which the DEA is aware are very small, and it does not appear to the DEA that it would be economically justifiable because DEA believes there is no legitimate market for manufacturing or engaging in commercial transactions in this chemical. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not Start Printed Page 32460conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
2. Amend § 1310.02 by redesignating paragraphs (a)(1) through (a)(30) as paragraphs (a)(2) through (a)(31), respectively, and adding a new paragraph (a)(1) to read as follows:
§ 1310.02
Substances covered.
(1) Alpha-phenylacetoacetonitrile and its salts, optical isomers, and salts of optical isomers (APAAN) 8512
3. Amend § 1310.04 by redesignating paragraphs (g)(1)(i) through (g)(1)(x) as paragraphs (g)(1)(ii) through (g)(1)(xi), respectively, and adding a new paragraph (g)(1)(i) to read as follows:
4. Amend § 1310.09 by adding paragraph (n) to read as follows:
(n)(1) Each person required under sections 302 and 1007 of the Act (21 U.S.C. 822, 957) to obtain a registration to manufacture, distribute, import, or export regulated alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, including regulated chemical mixtures pursuant to § 1310.12, is temporarily exempted from the registration requirement, provided that the DEA receives a properly completed application for registration or application for exemption for a chemical mixture containing alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, pursuant to § 1310.13 on or before August 14, 2017. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect.
5. Amend § 1310.12(c) by adding in alphabetical order an entry “Alpha-phenylacetoacetonitrile, and its salts, optical isomers, and salts of optical isomers. (APAAN)” in the table “Table of Concentration Limits” to read as follows:
Alpha-phenylacetoacetonitrile, and its salts, optical isomers, and salts of optical isomers. (APAAN) 8512 Not exempt at any concentration Chemical mixtures containing any amount of APAAN are not exempt.
Start Printed Page 32461