AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The Drug Enforcement Administration is proposing 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 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. APAA is used in and is important to the manufacture of the schedule II controlled substances amphetamine and methamphetamine. If finalized, this action would subject 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. This action does not propose the establishment of a threshold for domestic and international transactions of these chemicals. As such, all transactions involving any of these chemicals, regardless of size, would be regulated. In addition, this action proposes that chemical mixtures containing any of these three chemicals would not be exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of PMK glycidate, PMK glycidic acid, or APAA would be regulated.

DATES:

Electronic comments must be submitted, and written comments must be postmarked, on or before February 19, 2021. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.

ADDRESSES:

To ensure proper handling of comments, please reference “Docket No. DEA–542” on all correspondence, including any attachments.

Electronic comments: The Drug Enforcement Administration (DEA) encourages all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or to attach a file for lengthier comments. Please go to http://www.regulations.gov/​ and follow the online instructions at that site for submitting comments. Upon completion of your submission, you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on http://www.regulations.gov/​. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment.

Paper comments: Paper comments that duplicate the electronic submission are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

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:

Posting of Public Comments

Please note that all comments received are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.

Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document and supplemental information to this proposed rule are available at http://www.regulations.gov for easy reference.

Legal Authority

The Controlled Substances Act (CSA) gives the Attorney General the authority to specify, by regulation, a chemical as a “list I chemical;” 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.^[1] Pursuant to 28 CFR 0.100(b), the Attorney General has delegated his authority to so designate list I chemicals to the Administrator of DEA (Administrator). CSA regulations permit the Administrator to add a substance as a listed chemical by publishing a final rule in the Federal Register following the publication of a notice of proposed rulemaking that has provided at least 30 days for public comments.^[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

With the growing problem of illicit drug production, the issue of precursor chemical control has gained global attention. International efforts to prevent the illicit production of controlled substances and international control of precursors have made significant progress with this problem. Article 12 of the 1988 Convention established International controls on precursors. This Convention established two categories of controlled illicit drug precursor substances: Table I and Table II.^[3] Two international entities have played a crucial role in this effort: The United Nations Commission on Narcotic Drugs (CND) and the International Narcotics Control Board (INCB).

In response to domestic and international controls on precursors to the schedule I substance 3,4-methylenedioxymethamphetamine (MDMA), and schedule II substances amphetamine and methamphetamine, clandestine laboratory operators have continued to explore alternate methods to produce these illicit drugs, including the development of their own immediate precursors (“designer precursors”) and diversion of other precursors (pre-precursors) to produce these designer precursors. These clandestine laboratory operators often use 3,4-MDP-2-P methyl glycidate (PMK glycidate) and 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) as precursors to MDMA, and other “ecstasy”-type substances, and alpha -phenylacetoacetamide (APAA) as a precursor to amphetamine and methamphetamine.

“Precursor chemicals” are generally defined as chemical substances that become incorporated, at the molecular level, into a final product (including a controlled substance); it is a building block used to manufacture the final product/controlled substance. PMK glycidate and PMK glycidic acid are building blocks for the manufacture of the schedule I controlled substance MDMA, while APAA serves as a building block for the manufacture of the schedule II substance Phenyl-2-propanone (P2P), and subsequent final manufacture of the schedule II substances amphetamine and methamphetamine. All these chemicals meet the definition of list I chemicals since they are important to the manufacture of these controlled substances.

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 CND voted to place the chemicals PMK glycidate (and all stereoisomers), PMK glycidic acid (and all stereoisomers), and 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. As a Party to the 1988 Convention, the United States is obligated to control these substances pursuant to Article 12 of the 1988 Convention, as described in the above Legal Authority section. By designating PMK glycidate (and its optical and geometric isomers), PMK glycidic acid (and its salts, optical and geometric isomers, and salts of isomers), and APAA (and its optical isomers) as list I chemicals, the United States will fulfill its obligations under the 1988 Convention.^[4]

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 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 the illicit trafficking and use of these chemicals in manufacturing controlled substances, with increasing frequency and amounts reported in recent years.^[5]

In making its assessments pursuant to Article 12, paragraph 4, of the 1988 Convention, the CND found that there was no known legitimate manufacture of, and trade in, any of the three substances, and that their use was limited in small amounts to research, development, and laboratory analytical purposes. The inclusion of these substances in Table I would require Governments, as parties to the 1988 Convention, to establish pre-export notifications as a means of monitoring shipments entering their territories. Therefore, the CND voted to include PMK glycidate (all four stereoisomers), PMK glycidic acid (all four stereoisomers), and APAA (including its optical isomers) in Table I of the 1988 Convention.

Proposed Designation of PMK Glycidate, PMK Glycidic Acid, and APAA as List I Chemicals

For the reasons discussed above, the Acting Administrator of DEA finds that PMK glycidate, PMK glycidic acid, and APAA are used in the manufacture of a controlled substance in violation of the CSA, and are important to the manufacture of these controlled substances. Therefore, the Acting Administrator proposes the designation of PMK glycidate, PMK glycidic acid, and APAA as list I chemicals.

If finalized, handlers (manufacturers, distributors, importers, and exporters) of these chemicals would become subject to the chemical regulatory provisions of the CSA, including 21 CFR parts 1309, 1310, 1313, and 1316. Since even a small amount of these chemicals can potentially yield a significant amount of controlled substances, this action does not propose the establishment of a threshold for domestic, import, or export transactions in accordance with the provisions of 21 CFR 1310.04(g). Rather, DEA is proposing that all transactions, regardless of size, will be regulated transactions as defined in 21 CFR 1300.02(b). As such, if finalized, all PMK glycidate, PMK glycidic acid, and APAA transactions will be subject to recordkeeping, reporting, import and export controls, and other CSA chemical regulatory requirements. In addition, each regulated bulk manufacturer must submit manufacturing, inventory, and use data to DEA's Diversion Control Division, Drug and Chemical Evaluation section on an annual basis, in accordance with 21 CFR 1310.05(d).

Chemical Mixtures of PMK Glycidate, PMK Glycidic Acid or APAA

This rulemaking also proposes that 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. Therefore, all chemical mixtures containing any quantity of these three chemicals would be subject to CSA control. This rule proposes modification of 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.