The Drug Enforcement Administration is finalizing a December 21, 2020, notice of proposed rulemaking to designate three chemicals, known as PMK glycidate, PMK glycidic acid, and APAA, as list I chemicals under the Controlled Substances Act (CSA). PMK glycidate and PMK glycidic acid are used in and are important to the manufacture of the schedule I controlled substance 3,4-methylenedioxymethamphetamine (MDMA) and other “ecstasy”-type substances, and APAA is used in and is important to the manufacture of the schedule II controlled substances amphetamine and methamphetamine. This final rulemaking subjects handlers (manufacturers, distributors, importers, and exporters) of PMK glycidate, PMK glycidic acid, and APAA to the chemical regulatory provisions of the CSA and its implementing regulations.

DATES:

Effective June 9, 2021.

FOR FURTHER INFORMATION CONTACT:

Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION:

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,.

Legal Authority

The Controlled Substances Act (CSA) and the Drug Enforcement Administration's (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 1310.02(a).

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.

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, 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 3,4-methylenedioxymethamphetamine (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-2-propanone (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 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 1310.12(c) 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.