Designation of Propionyl Chloride as a List I Chemical

DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1310</CFR> <DEPDOC>[Docket No. DEA-1189]</DEPDOC> <SUBJECT>Designation of Propionyl Chloride 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 propionyl chloride as a list I chemical under the Controlled Substances Act (CSA). The Drug Enforcement Administration finds that propionyl chloride is used in the illicit manufacture of the controlled substances fentanyl, fentanyl analogues and fentanyl-related substances, and is important to the manufacture of these substances. In the respective synthetic pathways in which it is used to manufacture those substances, it is a replacement for propionic anhydride, which is currently a list I chemical. If finalized, the proposed rule would subject handlers of propionyl chloride to the chemical regulatory provisions of the CSA and its implementing regulations. This proposed rulemaking does not establish a threshold for domestic and international transactions of propionyl chloride. As such, all transactions of propionyl chloride, regardless of size, shall be regulated. In addition, chemical mixtures containing propionyl chloride are not exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of propionyl chloride shall be regulated pursuant to the CSA. Although no automatic exemption is available, manufacturers may submit an application for exemption. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be submitted electronically or postmarked on or before July 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-1189” 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">http://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, <E T="03">in lieu of</E> 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-1189. <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 rule may be found in the docket for this rulemaking at <E T="03">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 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</E> for public inspection. 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 a chemical that is used in manufacturing a controlled substance in violation of the CSA and is important to the manufacture of the controlled substance. <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 his 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 (NPRM) 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> <HD SOURCE="HD1">Background</HD> The clandestine manufacture of fentanyl, fentanyl analogues, and fentanyl-related substances remains extremely concerning as the distribution of illicit fentanyl, fentanyl analogues, and fentanyl-related substances continues to drive drug-related overdose deaths in the United States. Fentanyl is a synthetic opioid and was first synthesized in Belgium in the late 1950s. Fentanyl was introduced into medical practice and is approved for medical practitioners in the United States to prescribe lawfully for anesthesia and analgesia. Yet, due to its pharmacological effects, fentanyl can be used as a substitute for heroin, oxycodone, and other opioids in opioid dependent individuals. Therefore, despite its currently accepted medical use in treatment in the United States, DEA controls fentanyl as a schedule II controlled substance due to its high potential for abuse and the possibility that abuse may lead to severe psychological or physical dependence. <SU>3</SU> <FTREF/> Moreover, there are a substantial number of fentanyl analogues and fentanyl-related substances that are being distributed on the illicit drug market despite DEA's actions adding them as schedule I controlled substances. Illicit manufacturers attempt to utilize unregulated precursor chemicals to evade law enforcement detection and precursor chemical controls in order to manufacture fentanyl, fentanyl analogues, and fentanyl-related substances. This strategy allows for the synthesis of a variety of fentanyl analogues and fentanyl-related substances by making slight modifications to the core fentanyl structure while maintaining the same synthetic methodology used to synthesize fentanyl, fentanyl analogues, and fentanyl-related substances. <FTNT> <SU>3</SU>  21 U.S.C. 812(c) Schedule II(b)(6) and 21 CFR 1308.12(c). </FTNT> The unlawful trafficking of fentanyl, fentanyl analogues, and fentanyl-related substances in the United States continues to pose an imminent hazard to the public safety. Since 2012, fentanyl has shown a dramatic increase in the illicit drug supply as a single substance, in mixtures with other illicit drugs ( <E T="03">i.e.,</E> heroin, cocaine, and methamphetamine), and in forms that mimic pharmaceutical preparations including prescription opiates. <SU>4</SU> <FTREF/> <FTNT> <SU>4</SU>  National Drug Threat Assessment 2024, Drug Enforcement Administration, May 2024. </FTNT> DEA has noted a significant increase in overdoses and overdose fatalities from fentanyl, fentanyl analogues, and fentanyl-related substances in the United States in recent years. According to the Centers for Disease Control and Prevention (CDC), opioids, mainly synthetic opioids (which include fentanyl), are predominantly responsible for drug overdose deaths in recent years. According to CDC WONDER, <SU>5</SU> <FTREF/> drug-induced overdose deaths involving synthetic opioids (excluding methadone) in the United States increased from 36, ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 46k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━