Federal Register - May 10, 2021

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Source: Federal Register

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Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations
This final rule designates the following chemicals as list I chemicals and subjects them to the regulatory requirements applicable to list I chemicals:
3,4-MDP-2-P methyl glycidate PMK
glycidate, including its optical and geometric isomers;
3,4-MDP-2-P methyl glycidic acid PMK glycidic acid, including its salts, optical and geometric isomers, and salts of isomers; and alpha-phenylacetoacetamide APAA, including its optical isomers,.

SUPPLEMENTARY INFORMATION:

Legal Authority The Controlled Substances Act CSA
and the Drug Enforcement Administrations DEA implementing regulations give the Attorney General, as delegated to the Administrator of DEA, the authority to specify, by regulation, a chemical as a list I chemical. 1 This term refers to a chemical that is used in manufacturing a controlled substance in violation of subchapter I Control and Enforcement of the CSA and is important to the manufacture of the controlled substance.2 The current list of all list I chemicals is available in 21
CFR 1310.02a.
In addition, the United States is a Party to the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances 1988 Convention, December 20, 1988, 1582 U.N.T.S. 95.
Under Article 12 of the 1988
Convention, when the United States receives notification that a chemical has been added to Table I or Table II tables annexed to such Convention, the United States must take measures it deems appropriate to monitor the manufacture and distribution of that chemical within the United States and to prevent its diversion, including measures related to international trade.

khammond on DSKJM1Z7X2PROD with RULES

Background In a letter dated May 23, 2019, the Secretary-General of the United Nations, in accordance with Article 12, paragraph 6 of the 1988 Convention, informed the United States Secretary of State that the Commission on Narcotic Drugs CND voted to place the chemicals 3,4-MDP-2-P methyl glycidate PMK glycidate and all stereoisomers, 3,4-MDP-2-P methyl glycidic acid PMK
glycidic acid and all stereoisomers, and alpha-phenylacetoacetamide APAA and all optical isomers in Table I of the 1988 Convention CND
Decisions 62/10, 62/11, and 62/12, 1 21 U.S.C. 80234 and 871b and 21 CFR
1310.02c.
2 21 U.S.C. 80234 and 21 CFR 1300.02b.

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respectively at its 62nd Session on March 19, 2019.
On December 21, 2020, DEA
published a notice of proposed rulemaking NPRM 85 FR 82984 to designate 3,4-MDP-2-P methyl glycidate PMK glycidate, including its optical and geometric isomers; 3,4-MDP-2-P
methyl glycidic acid PMK glycidic acid, including its salts, optical and geometric isomers, and salts of isomers;
and alpha-phenylacetoacetamide APAA, including its optical isomers, as list I chemicals under the CSA.3
PMK glycidate, PMK glycidic acid, and APAA are close chemical relatives of controlled list I precursor 3,4
methylenedioxyphenyl-2-propanone 3,4-MDP-2-P, and have been made specifically to circumvent existing precursor controls. DEA has not identified any known legitimate uses for these chemicals, other than possible research purposes. The first two substances, PMK glycidate and PMK
glycidic acid, are closely related in chemical structure to precursors of 3,4methylenedioxymethamphetamine MDMA schedule I and other ecstasy-type substances in schedule I.
APAA is a precursor of schedule II
controlled substances amphetamine and methamphetamine.
All three chemicals are used for the illicit manufacture of two precursors listed in Table I of the 1988 Convention 3,4-MDP-2-P and 1-phenyl-2propanone P-2-P. For years, countries have reported to the International Narcotics Control Board INCB the illicit trafficking and use of these chemicals in manufacturing controlled substances, with increasing frequency and amounts reported in 2018 and 2019.4
Comments Received and Designation of PMK Glycidate, PMK Glycidic Acid, and APAA as List I Chemicals In response to the December 21, 2020, NPRM, DEA received one anonymous comment expressing general opposition to the war on drugs and to the addition of more substances to the list 3 DEA proposed to control the same set of chemicals specified by the CND. However, DEA
used more precise terms that relate to the specific chemical and variations that can actually exist.
4 Precursors and Chemicals Frequently Used in the Illicit Manufacture of Narcotic Drugs and Psychotropic Substances: Report of the International Narcotics Control Board for 2018 on the Implementation of Article 12 of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 E/INCB/2018/4, Released March 5, 2019 and Report of the International Narcotics Control Board for 2019 on the Implementation of Article 12 of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 E/INCB/2019/1, Released February 27. 2020

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and under CSA control. DEA considers the general comment about the war on drugs to be outside the scope of this rulemaking.
Regarding the general opposition to listing more substances, DEA notes that it proposed to designate and add these three specific chemicals to the list as they met the statutory and regulatory definition of a list I chemical, and DEA
is using its legal authority to so designate these chemicals as list I
chemicals.
Therefore, for the reasons discussed in the NPRM, and reiterated in the above background section, the Acting Administrator of DEA finds that PMK
glycidate, PMK glycidic acid, and APAA
are used in the manufacture of controlled substances in violation of the CSA, and are important to the manufacture of these controlled substances. Therefore, the Acting Administrator designates PMK
glycidate, PMK glycidic acid, and APAA
as list I chemicals.
Chemical Mixtures of PMK Glycidate, PMK Glycidic Acid or APAA
Pursuant to this final rulemaking, chemical mixtures containing any of these three chemicals are subject to regulatory requirements at any concentration unless a manufacturer submits to DEA an application for exemption of a chemical mixture, DEA
accepts the application for filing, and DEA exempts the chemical mixture in accordance with 21 CFR 1310.13
Exemption of chemical mixtures;
application. Since even a small amount of these three chemicals can potentially yield a significant amount of controlled substances, DEA believes that regulation of chemical mixtures containing any amount of these three chemicals is necessary to prevent their illicit extraction, isolation, and use. This rule modifies the Table of Concentration Limits in 21 CFR 1310.12c to reflect the fact that chemical mixtures containing any amount of these three chemicals are subject to CSA chemical control provisions, including 21 CFR
parts 1309, 1310, 1313, and 1316.
Application Process for Exemption of Chemical Mixtures DEA has implemented an application process to exempt certain chemical mixtures from the requirements of the CSA and its implementing regulations.5
Manufacturers may submit an 5 21 CFR 1310.13 specifies that this chemical mixture is a chemical mixture consisting of two or more chemical components, at least one of which is not a list I or list II chemical, and the mixture and its listed chemicals must meet certain other conditions.

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Federal Register - May 10, 2021

TitoloFederal Register

PaeseStati Uniti

Data10/05/2021

Conteggio pagine1111

Numero di edizioni7798

Prima edizione14/03/1936

Ultima edizione18/06/2026

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