Designation of P2P Methyl Glycidic Acid as a List I Chemical

DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1310</CFR> <DEPDOC>[Docket No. DEA-1395]</DEPDOC> <SUBJECT>Designation of P2P Methyl Glycidic Acid as a List I Chemical</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice. <HD SOURCE="HED">ACTION:</HD> Notice of proposed rulemaking. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Drug Enforcement Administration is proposing the control of the chemical 2-methyl-3-phenyloxirane-2-carboxylic acid (also known as P2P methyl glycidic acid and BMK glycidic acid) and its esters, its optical and geometric isomers, its salts, salts of its optical and geometric isomers and its esters, and any combination thereof, whenever the existence of such is possible, as a list I chemical under the Controlled Substances Act (CSA). P2P methyl glycidic acid is important to the manufacture of the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine, and it is used in clandestine laboratories to illicitly manufacture these controlled substances. If finalized, this proposed rule would subject handlers of P2P methyl glycidic acid to the chemical regulatory provisions of the CSA and its implementing regulations. This rulemaking does not establish a threshold for domestic and international transactions of P2P methyl glycidic acid. As such, all transactions of P2P methyl glycidic acid, regardless of size, shall be regulated. In addition, chemical mixtures containing P2P methyl glycidic acid are not exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of P2P methyl glycidic acid shall be regulated pursuant to the CSA. However, manufacturers may submit an application for exemption for those mixtures that do not qualify for automatic exemption. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be submitted electronically or postmarked on or before November 3, 2025. Commenters should be aware that the electronic Federal Docket Management System will not accept any comments after 11:59 p.m. Eastern Time on the last day of the comment period. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> To ensure proper handling of comments, please reference “Docket No. DEA-1395” on all electronic and written correspondence, including any attachments. • <E T="03">Electronic comments:</E> The Drug Enforcement Administration encourages that 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 attach a file for lengthier comments. Please go to <E T="03">https://www.regulations.gov</E> 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 <E T="03">Regulations.gov</E> . If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. • <E T="03">Paper comments:</E> Paper comments that duplicate electronic submissions are not necessary. 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. • <E T="03">Paperwork Reduction Act comments:</E> All comments concerning collections of information under the Paperwork Reduction Act must be submitted to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please state that your comment refers to Docket No. DEA-1395. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362- 3249. As required by 5 U.S.C. 553(b)(4), a summary of this proposed rule may be found in the docket for this rulemaking at <E T="03">http://www.regulations.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Posting of Public Comments</HD> Please note that all comments received in response to this docket are considered part of the public record. DEA generally will make comments available for public inspection online at <E T="03">http://www.regulations.gov.</E> Such information includes personal or business identifiers (such as name, address, state or Federal identifiers, etc.) voluntarily submitted by the commenter. Generally, all information voluntarily submitted by the commenter, unless clearly marked as Confidential Information in the method described below, will be publicly posted. Comments may be submitted anonymously. The Freedom of Information Act applies to all comments received. Commenters submitting comments which include personal identifying information (PII), confidential, or proprietary business information that the commenter does not want made publicly available should submit two copies of the comment. One copy must be marked “CONTAINS CONFIDENTIAL INFORMATION” and should clearly identify all PII or business information the commenter does not want to be made publicly available, including any supplemental materials. DEA will review this copy, including the claimed PII and confidential business information, in its consideration of comments. The second copy should be marked “TO BE PUBLICLY POSTED” and must have all claimed confidential PII and business information already redacted. DEA will post only the redacted comment on <E T="03">http://www.regulations.gov for public inspection.</E> For easy reference, an electronic copy of this document and supplemental information to this proposed scheduling action are available at <E T="03">http://www.regulations.gov.</E> <HD SOURCE="HD1">Legal Authority</HD> The Controlled Substances Act (CSA) gives the Attorney General the authority to specify, by regulation, chemicals as list I chemicals. <SU>1</SU> <FTREF/> A “list I chemical” is defined as “a chemical that is used in manufacturing a controlled substance in violation of [the CSA] and is important to the manufacture of the controlled substances.”  <SU>2</SU> <FTREF/> 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 her authority to designate list I chemicals to the Administrator of DEA (Administrator). DEA regulations set forth the process by which DEA may add a chemical as a listed chemical. As set forth in 21 CFR 1310.02(c), the agency may do so by publishing a final rule in the <E T="04">Federal Register</E> following a published notice of proposed rulemaking with at least 30 days for public comments. <FTNT> <SU>1</SU>  21 U.S.C. 802(34). </FTNT> <FTNT> <SU>2</SU>   <E T="03">Id.</E> </FTNT> 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), Dec. 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 of the 1988 Convention, the United States is required to 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. <HD SOURCE="HD1">Background</HD> By letter dated June 6, 2022, in accordance with Article 12, paragraph 6 of the 1988 Convention, the Secretary-General of the United Nations informed the United States that the chemicals P2P methyl glycidic acid and specific esters of P2P methyl glycidic acid, including their optical isomers, were added to Table I of the 1988 Convention. This letter was prompted by a decision of the United Nations Commission on Narcotic Drugs (CND) to add P2P methyl glycidic acid and specific esters of P2P methyl glycidic acid to Table I during its 67th Session on March 19, 2024. As discussed above, the United States is a party to the 1988 Convention and has certain obligations pursuant to Article 12. By designating P2P methyl glycidic acid, as well as its esters and their optical and geometric isomers, as list I chemicals, the United States will fulfill its obligations under the 1988 Convention. P2P methyl glycidic acid is used in, and is important to, the manufacture of the schedule II substances phenylacetone (also known as phenyl-2-propanone, P2P, or benzyl methyl ketone), methamphetamine, and amphetamine. Throughout the 1970s, methamphetamine was illicitly produced in the United States, primarily with the precursor chemical P2P. In response to the illicit use of P2P, DEA controlled P2P as a schedule II controlled substance in 1980 pursuant to the “immediate precursor” provisions of the CSA, specifically 21 U.S.C. 811(e). <SU>3</SU> <FTREF/> Clandestine laboratory operators have circumvented this control by developing a variety of synthetic methods for producing P2P. <FTNT> <SU>3</SU>   <E T="03">Schedules of Controlled Substances; Schedule II Placement of Phenylacetone; (Phenyl-2-propanone, P2P, benzyl methyl ketone, methyl benzyl ketone),</E> 44 FR 71822 (Dec. 12, 1979). </FTNT> Congress and DEA responded by placing controls on certain chemicals used in the illicit production of P2P, such as phenylacetic acid (and its salts and esters), acetic anhydride, benzyl cyanide, benzaldehyde, and nitroethane. <E T="51">4 5</E> <FTREF/> However, clandestine laboratory operators circumv ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 55k characters. 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