[Federal Register Volume 90, Number 105 (Tuesday, June 3, 2025)]
[Proposed Rules]
[Pages 23483-23489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09983]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-1189]
Designation of Propionyl Chloride as a List I Chemical
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: 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.
DATES: 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.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-1189'' on all electronic and written correspondence,
including any attachments.
Electronic comments: 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 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
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 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,
[[Page 23484]]
8701 Morrissette Drive, Springfield, Virginia 22152.
Paperwork Reduction Act Comments: 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.
FOR FURTHER INFORMATION CONTACT: 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 www.regulations.gov.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
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 http://www.regulations.gov.
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 http://www.regulations.gov for public inspection.
For easy reference, an electronic copy of this document and
supplemental information to this proposed scheduling action are
available at http://www.regulations.gov.
Legal Authority
The Controlled Substances Act (CSA) gives the Attorney General the
authority to specify, by regulation, chemicals as list I chemicals.\1\
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.\2\ 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 Federal Register following a
published notice of proposed rulemaking (NPRM) with at least 30 days
for public comments.
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\1\ 21 U.S.C. 802(34).
\2\ Id.
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Background
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.\3\ 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.
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\3\ 21 U.S.C. 812(c) Schedule II(b)(6) and 21 CFR 1308.12(c).
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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 (i.e., heroin, cocaine, and
methamphetamine), and in forms that mimic pharmaceutical preparations
including prescription opiates.\4\
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\4\ National Drug Threat Assessment 2024, Drug Enforcement
Administration, May 2024.
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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,\5\ drug-induced overdose deaths involving synthetic opioids
(excluding methadone) in the United States increased from 36,359 in
2019 to 56,516 in 2020 to 70,601 in 2021, and 73,838 in 2022. Based on
provisional data, the predicted number of drug overdose deaths
involving synthetic opioids (excluding methadone) in the United States
for the 12 months ending March 2024 is 70,972 individuals, or
approximately 70 percent of all drug-induced overdose deaths for that
time period.\6\ The increase in overdose fatalities involving synthetic
opioids coincides with a dramatic increase in law enforcement
encounters of fentanyl, fentanyl analogues, and fentanyl-related
[[Page 23485]]
substances. According to the National Forensic Laboratory Information
System (NFLIS-Drug),\7\ reports from forensic laboratories of drug
items containing fentanyl, fentanyl analogues, and fentanyl-related
substances increased dramatically since 2014, as shown in Table 1.
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\5\ Centers for Disease Control and Prevention, National Center
for Health Statistics. National Vital Statistics System, Provisional
Mortality on CDC WONDER Online Database. Data are from the final
Multiple Cause of Death Files, 2018-2022, and from provisional data
for years 2022-2024, as compiled from data provided by the 57 vital
statistics jurisdictions through the Vital Statistics Cooperative
Program. Accessed at http://wonder.cdc.gov/mcd-icd10-provisional.html on August 16, 2024.
\6\ Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional drug
overdose death counts. National Center for Health Statistics. 2024.
Accessed at https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm on August 16, 2024.
\7\ The National Forensic Laboratory Information System (NFLIS-
Drug) is a national forensic laboratory reporting system that
systematically collects results from drug chemistry analyses
conducted by Federal, State and local forensic laboratories in the
United States. While NFLIS-Drug data is not direct evidence of
abuse, it can lead to an inference that a drug has been diverted and
abused. See 76 FR 77330, 77332 (December 12, 2011). NFLIS-Drug data
was queried on December 14, 2023.
Table 1--Annual Reports of Fentanyl and Select Fentanyl Analogues and Fentanyl-Related Substances Identified in Drug Encounters
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Year 2014 2015 2016 2017 2018 2019 2020 2021 2022
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Annual Fentanyl Reports........................................ 5,554 15,461 37,155 61,644 89,974 108,138 126,042 165,486 168,768
Annual Reports of select fentanyl analogues and fentanyl- 78 2,317 7,624 21,981 16,177 20,918 7,804 26,468 29,919
related substances............................................
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Role of Propionyl Chloride in the Synthesis of Fentanyl
Fentanyl, fentanyl analogues, and fentanyl-related substances are
not naturally occurring substances. As such, the manufacture of these
substances requires them to be produced through synthetic organic
chemistry. Synthetic organic chemistry is the process in which a new
organic molecule is created through a series of chemical reactions,
which involve precursor chemicals. Through chemical reactions, the
chemical structures of precursor chemicals are modified in a desired
fashion. These chemical reaction sequences, also known as synthetic
pathways, are designed to create a desired substance. Several synthetic
pathways to fentanyl, fentanyl analogues, and fentanyl-related
substances have been identified in clandestine laboratory settings;
these include the original ``Janssen method,'' the ``Siegfried
method,'' and the ``Gupta method.'' In response to the illicit
manufacture of fentanyl, fentanyl analogues, and fentanyl-related
substances using these methods, DEA controlled N-phenethyl-4-piperidone
(NPP); \8\ N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide
(benzylfentanyl) and its salts; \9\ N-phenylpiperidin-4-amine (4-
anilinopiperidine) including its amides, halides, carbamates, salts,
and any combination thereof; \10\ and 4-piperidone (piperidin-4-one)
including its acetals, amides, carbamates, salts, and salts of acetals,
amides, and carbamates, and any combination thereof \11\ as list I
chemicals. DEA also controls 4-anilino-N-phenethylpiperidine (ANPP)
\12\ and N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl) \13\ as
schedule II immediate precursors under the CSA.
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\8\ Control of a Chemical Precursor Used in the Illicit
Manufacture of Fentanyl as a List I Chemical, 72 FR 20039 (Apr. 23,
2007).
\9\ Designation of Benzylfentanyl and 4-Anilinopiperidine,
Precursor Chemicals Used in the Illicit Manufacture of Fentanyl, as
List I Chemicals, 85 FR 20822 (Apr. 15, 2020).
\10\ Designation of Benzylfentanyl and 4-Anilinopiperidine,
Precursor Chemicals Used in the Illicit Manufacture of Fentanyl, as
List I Chemicals, 85 FR 20822 (Apr. 15, 2020).); See Also
Designation of Halides of 4-Anilinopiperidine as List 1 Chemicals,
88 FR 74352 (Oct. 31, 2023).
\11\ Designation of 4-Piperidone as a List I Chemical, 88 FR
21902-21910 (Apr. 12, 2023).
\12\ Control of Immediate Precursor Used in the Illicit
Manufacture of Fentanyl as a Schedule II Controlled Substance, 75 FR
37295 (June 29, 2010).
\13\ Control of the Immediate Precursor Norfentanyl Used in the
Illicit Manufacture of Fentanyl as a Schedule II Controlled
Substance, 85 FR 21320 (Apr. 17, 2020).
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Propionyl Chloride
The original published synthetic pathway to fentanyl, known as the
Janssen method, involves the list I chemical benzylfentanyl and
schedule II immediate precursor norfentanyl. In this synthetic pathway,
benzylfentanyl, a list I chemical under the CSA,\14\ is synthesized by
reacting propionyl chloride with 4-anilino-1-benzylpiperidine, which is
then converted to norfentanyl, the schedule II immediate precursor in
this synthetic pathway.\15\ Norfentanyl is then subjected to one simple
chemical reaction to complete the synthesis of fentanyl. This synthetic
pathway can also be easily modified to produce fentanyl analogues and
fentanyl-related substances. Propionyl chloride also serves as a
precursor chemical in the Siegfried method. In this synthetic pathway,
propionyl chloride is reacted with ANPP,\16\ the schedule II immediate
precursor in the Siegfried method, to complete the synthesis of
fentanyl. This synthetic pathway can also be easily modified to produce
fentanyl analogues and fentanyl-related substances. In addition to the
Janssen and Siegfried methods, clandestine manufacturers are using
other methods to synthesize fentanyl, one of which is known as the
Gupta method. In this synthetic pathway, 4-piperidone, a list I
chemical under the CSA, is used to synthesize 4-anilinopiperidine,
another list I chemical under the CSA,\17\ which serves as an
alternative precursor chemical to NPP, a list I chemical, in the
synthesis of ANPP, a schedule II immediate precursor albeit through a
different synthetic process. The resulting ANPP is reacted with
propionyl chloride to manufacture the schedule II controlled substance,
fentanyl. This synthetic pathway can also be easily modified to produce
fentanyl analogues and fentanyl-related substances.
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\14\ See footnote 10.
\15\ See footnote 13.
\16\ See footnote 12.
\17\ Designation of Benzylfentanyl and 4-Anilinopiperidine,
Precursor Chemicals Used in the Illicit Manufacture of Fentanyl, as
List I Chemicals, 85 FR 20822 (May 15, 2020).
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Propionyl chloride is attractive to illicit manufacturers because
there is a lack of regulations on this chemical, it is readily
available from chemical suppliers, and it can be easily used in many
known synthetic pathways used in the illicit manufacture of fentanyl,
fentanyl analogues, and fentanyl-related substances.
Information Gathered by DEA Concerning Propionyl Chloride
On October 12, 2023, DEA published in the Federal Register an
Advance Notice of Proposed Rulemaking (ANPRM) \18\ in anticipation of
proposing to designate propionyl chloride as a list I chemical. The
ANPRM invited interested persons to submit information related to
current uses of propionyl chloride (other than for the synthesis of
fentanyl) in order to properly determine the effect such a proposed
action would have on legitimate industry.
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\18\ Propionyl Chloride, 88 FR 70610 (Oct. 12, 2023).
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DEA solicited input from all potentially affected parties
regarding: (1) The types of legitimate industries using propionyl
chloride; (2) the legitimate uses, legitimate needs and quantity
[[Page 23486]]
produced, used, and distributed of propionyl chloride; (3) the size of
the domestic market for propionyl chloride; (4) the number of
manufacturers of propionyl chloride; (5) the number of distributors of
propionyl chloride; (6) the level of import and export of propionyl
chloride; (7) the potential burden that controlling propionyl chloride
as a list I chemical may have on any legitimate industry and trade; (8)
the potential number of individuals/firms that may be adversely
affected by such regulatory controls (particularly with respect to the
impact on small businesses); and (9) any other information on the
manner of manufacturing, distribution, consumption, storage, disposal,
and uses of propionyl chloride by industry and others. DEA invited all
interested parties to provide any information on any legitimate uses of
propionyl chloride in industry, commerce, academia, research and
development, or other applications. DEA sought both quantitative and
qualitative data.
Comments
DEA received six responses to the ANPRM. Three of the comments were
in support of the control of propionyl chloride as a list I chemical,
while three comments offered potential problems with controlling
propionyl chloride.
Relevant to solicitations (1) and (2), three commenters stated that
propionyl chloride has potential use as a reagent for chemical
synthesis processes, including in the natural product syntheses of N-
deoxymilitarinone A and torrubiellone B, potential pharmaceutical
development, resin/materials development, and agricultural chemicals.
One of the commenters stated that it may have uses for the medical
field, without providing additional detail. While one of the comments
provided patent numbers and a published letter to support the existence
of these potential uses, there were no details allowing DEA to identify
the existence or extent of the actual use of propionyl chloride for
these purposes.
Relevant to solicitation (7), two commenters stated that
controlling propionyl chloride as a list I chemical is likely to have a
burden on legitimate industry and trade in that it will make the
chemical more expensive and difficult to access for chemical and
pharmaceutical research labs and will ``impact researchers greatly.'' A
third commenter stated that distributors, manufacturers, importers, and
exporters of propionyl would be required to pay DEA registration fees
if propionyl chloride is placed in list I. Another commenter, however,
stated that it may primarily be used by ``personnel who would already
possess any documentation needed to obtain it.''
Relevant to solicitation (8), one commenter stated that PubChem
lists 43 vendors currently offering to supply propionyl chloride.
Regulation of Propionyl Chloride as a List I Chemical
The CSA, specifically 21 U.S.C. 802(34), and its implementing
regulations at 21 CFR 1310.02(c), provide the Attorney General with the
authority to specify, by regulation, additional precursor or essential
chemicals as listed chemicals if they are used in the manufacture of
controlled substances in violation of the CSA. Recent law enforcement
encounters indicate propionyl chloride is being used in the illicit
manufacture of the schedule II controlled substance fentanyl. This
proposed rule would regulate propionyl chloride as a list I chemical
because DEA finds that propionyl chloride is used in the illicit
manufacture of the controlled substance fentanyl, and is important to
the manufacture of the controlled substance fentanyl because it can be
used as a replacement for the list I chemical propionic anhydride in
its respective synthetic pathways which are used in the illicit
manufacture of fentanyl.
Chemical Mixtures of Propionyl Chloride
This proposed rulemaking, if finalized, would specify that chemical
mixtures containing propionyl chloride would not be exempt from
regulatory requirements at any concentration, unless an application for
exemption of a chemical mixture is submitted by a propionyl chloride
manufacturer and the application is reviewed and accepted by DEA under
21 CFR 1310.13. The control of chemical mixtures containing any amount
of propionyl chloride is necessary to prevent the extraction,
isolation, and use of propionyl chloride in the illicit manufacture of
fentanyl. This proposed rule would modify the Table of Concentration
Limits in 21 CFR 1310.12(c) to reflect the fact that chemical mixtures
containing any amount of propionyl chloride are subject to the CSA
chemical control provisions.
Exemption by Application Process
DEA has implemented an application process to exempt mixtures from
the requirements of the CSA and its implementing regulations.\19\ Under
the application process, manufacturers may submit an application for
exemption for those mixtures that do not qualify for automatic
exemption. Exemption status can be granted if DEA determines that the
mixture is formulated in such a way that it cannot be easily used in
the illicit production of a controlled substance and that the listed
chemical cannot be readily recovered.\20\
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\19\ 21 CFR 1310.13.
\20\ 21 CFR U.S.C. 802(39)(A)(vi).
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Requirements for Handling List I Chemicals
If this rule is finalized as proposed, propionyl chloride will be
subject to all of the regulatory controls and administrative, civil,
and criminal sanctions applicable to the manufacture, distribution,
importing, and exporting of list I chemicals. Upon publication of a
final rule, persons potentially handling propionyl chloride, including
regulated chemical mixtures containing propionyl chloride, will be
required to comply with list I chemical regulations, including the
following:
1. Registration. Any person who manufactures, distributes, imports,
or exports propionyl chloride, including chemical mixtures containing
propionyl chloride, or proposes to engage in the manufacture,
distribution, importation, or exportation of propionyl chloride,
including chemical mixtures containing propionyl chloride, must obtain
a registration pursuant to 21 U.S.C. 822, 823, 957, and 958.
Regulations describing registration for list I chemical handlers are
set forth in 21 CFR part 1309. DEA regulations require separate
registrations for manufacturing, distributing, importing, and exporting
of list I chemicals. 21 CFR 1309.21. Further, a separate registration
is required for each principal place of business at one general
physical location where list I chemicals are manufactured, distributed,
imported, or exported by a person. 21 U.S.C. 822(e)(1) and 21 CFR
1309.23(a).
DEA notes that under the CSA, ``warehousemen'' are not required to
register and may lawfully possess list I chemicals, if the possession
of those chemicals is in the usual course of business or employment.
Under DEA implementing regulations, the warehouse in question must
receive the list I chemical from a DEA registrant and shall only
distribute the list I chemical back to the DEA registrant and
registered location from which it was received. A warehouse that
distributes list I chemicals to persons other than the registrant and
registered location from
[[Page 23487]]
which they were obtained is conducting distribution activities and is
required to register as such.
Upon publication of a final rule, any person manufacturing,
distributing, importing, or exporting propionyl chloride or a chemical
mixture containing propionyl chloride would become subject to the
registration requirement under the CSA. DEA recognizes, however, that
it is not possible for persons who are subject to the registration
requirements to immediately complete and submit an application for
registration, and for DEA to immediately issue registrations for those
activities. Therefore, to allow any continued legitimate commerce in
propionyl chloride or a chemical mixture containing propionyl chloride,
DEA is proposing to establish in 21 CFR 1310.09, a temporary exemption
from the registration requirement for persons desiring to engage in
activities with propionyl chloride or a chemical mixture containing
propionyl chloride, provided that DEA receives a properly completed
application for registration or application for exemption of a chemical
mixture under 21 CFR 1310.13 on or before 30 days after publication of
a final rule implementing regulations regarding propionyl chloride. The
temporary exemption for such persons will remain in effect until DEA
takes final action on their application for registration or application
for exemption of a chemical mixture.
The temporary exemption applies solely to the registration
requirement; all other chemical control requirements, including
recordkeeping and reporting, would become effective on the effective
date of the final rule. This is necessary because a delay in regulating
these transactions could result in increased diversion of chemicals
desirable to drug traffickers.
Additionally, the temporary exemption for registration does not
suspend applicable federal criminal laws relating to propionyl
chloride, nor does it supersede State or local laws or regulations. All
handlers of propionyl chloride must comply with applicable State and
local requirements in addition to the CSA regulatory controls.
2. Records and Reports. Every DEA registrant would be required to
maintain records and submit reports with respect to propionyl chloride
pursuant to 21 U.S.C. 830 and in accordance with 21 CFR 1310.04 and
1310.05. Pursuant to 21 CFR 1310.04, a record must be kept for two
years after the date of a transaction involving a listed chemical,
provided the transaction is a regulated transaction.
Each regulated bulk manufacturer of a listed chemical will be
required to submit manufacturing, inventory, and use data on an annual
basis. 21 CFR 1310.05(d). Existing standard industry reports containing
the required information are acceptable, provided the information is
separate or readily retrievable from the report.
The CSA and its implementing regulations require that each
regulated person must report to DEA any regulated transaction involving
an extraordinary quantity of a listed chemical, an uncommon method of
payment or delivery, or any other circumstance that the regulated
person believes may indicate that the listed chemical will be used in
violation of subchapter I of the CSA. In addition, regulated persons
must report any proposed regulated transaction with a person whose
description or other identifying characteristics DEA has previously
furnished to the regulated person, any unusual or excessive loss or
disappearance of a listed chemical under the control of the regulated
person, and any in-transit loss in which the regulated person is the
supplier. 21 U.S.C. 830(b) and 21 CFR 1310.05(a) and (b).
3. Importation and Exportation. All importation and exportation of
propionyl chloride or a chemical mixture containing propionyl chloride
would need to be done in compliance with 21 U.S.C. 957, 958, and 971
and in accordance with 21 CFR part 1313.
4. Security. All applicants and registrants would be required to
provide effective controls against theft and diversion of list I
chemicals in accordance with 21 CFR 1309.71-1309.73.
5. Administrative Inspection. Places, including factories,
warehouses, or other establishments and conveyances, where registrants
or other regulated persons may lawfully hold, manufacture, distribute,
or otherwise dispose of a list I chemical or where records relating to
those activities are maintained, are controlled premises as defined in
21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for
administrative inspections of these controlled premises as provided in
21 CFR part 1316, subpart A. 21 U.S.C. 880.
6. Liability. Any activity involving propionyl chloride not
authorized by, or in violation of, the CSA, would be unlawful, and
would subject the person to administrative, civil, and/or criminal
action.
Regulatory Analyses
Executive Orders 12866, 1356, and 14192 (Regulatory Review)
DEA has determined that this rulemaking is not a ``significant
regulatory action'' under section 3(f) of Executive Order (E.O.) 12866,
Regulatory Planning and Review. Accordingly, this proposed rule has not
been submitted to the Office of Management and Budget for review. This
proposed rule has been drafted and reviewed in accordance with E.O.
12866, ``Regulatory Planning and Review,'' section 1(b), Principles of
Regulation and E.O. 13563, ``Improving Regulation and Regulatory
Review,'' section 1(b), General Principles of Regulation. DEA
scheduling actions are not subject to E.O. 14192, ``Unleashing
Prosperity Through Deregulation.''
DEA is proposing the control of propionyl chloride as a list I
chemical under the CSA. DEA 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. The replacement chemical for propionyl
chloride in the respective pathways is already 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. If finalized as proposed, propionyl chloride will
be subject to all of the regulatory control and administrative, civil,
and criminal sanctions applicable to the manufacture, distribution,
importing, and exporting of list I chemicals.
DEA evaluated the cost of this proposed rule. Due to many unknowns,
DEA is unable to provide an estimated cost of this proposed rule;
however, DEA believes the cost will not be significant and will be far
below the E.O. 12866 3(f)(1) threshold.
Propionyl chloride is used for the legitimate manufacturing of
pharmaceutical fentanyl as well as clandestinely synthesized illicit
fentanyl. DEA has searched information
[[Page 23488]]
in the public domain for legitimate uses of propionyl chloride and has
not documented a legitimate commercial or industrial use for propionyl
chloride other than as an intermediary chemical in the production of
fentanyl. DEA welcomes any comments related to the uses of propionyl
chloride in the legitimate marketplace.
The primary costs associated with this proposed rule would be the
annual registration fee for list I chemicals ($3,699 for manufacturers
and $1,850 for distributors, importers, and exporters). DEA has
identified 20 domestic distributors of propionyl chloride. Three are
already registered to handle list I chemicals, and this rule will not
have impacts on their operations. The remaining distributors will need
to register with DEA and employ security and handling processes to
continue supplying propionyl chloride. For the nonregistered suppliers,
it is difficult to estimate the amount of propionyl chloride that they
distribute. It is also common for these chemical distributors to have
items in their catalog while not actually having any material level of
sales. Hence, DEA expects the quantities of propionyl chloride
distributed by nonregistered distributors is much smaller compared to
the registered distributors. If this proposed rule is finalized, these
distributors are expected to choose the least cost option, and stop
selling propionyl chloride, rather than incur the registration cost.
DEA expects that the cost of foregone sales is small; and thus, the
cost of this proposed rule is minimal. DEA welcomes any public comment
regarding this estimate.
In summary, DEA conducted a qualitative analysis of this proposed
rule. DEA believes any manufacturer or distributor that uses propionyl
chloride for legitimate pharmaceutical fentanyl production already
would be registered with DEA and have all security and other handling
processes in place, such that this regulation would result in minimal
cost to those entities. Therefore, any potential cost as a result of
this regulation is minimal.
Executive Order 12988, Civil Justice Reform
This proposed regulation meets the applicable standards set forth
in sections 3(a) and 3(b)(2) of E.O. 12988 Civil Justice Reform to
eliminate drafting errors and ambiguity, minimize litigation, provide a
clear legal standard for affected conduct, and promote simplification
and burden reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not have federalism implications
warranting the application of E.O. 13132. The proposed rule does not
have substantial direct effects on the States, on the relationship
between the national Government and the States, or the distribution of
power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed rule does not have tribal implications warranting the
application of E.O. 13175. This proposed rule does not have substantial
direct effects on one or more Indian tribes, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes.
Regulatory Flexibility Act
The Acting Administrator, in accordance with the Regulatory
Flexibility Act, 5 U.S.C. 601-612, has reviewed this rule and by
approving it, certifies that it will not have a significant economic
impact on a substantial number of small entities.
As discussed above, if finalized as proposed, propionyl chloride
and chemical mixtures containing propionyl chloride will be subject to
all of the regulatory controls and administrative, civil, and criminal
sanctions applicable to the manufacture, distribution, importing, and
exporting of list I chemicals. If finalized, it will affect all
business activities that handle propionyl chloride including
manufacturers, distributors, importers, and exporters. DEA identified
20 domestic suppliers, 17 (85 percent) of which are not registered with
DEA to handle list I chemicals. All non-registered entities will be
affected by this rule and are small entities based on Small Business
Administration classification for Other Chemical and Allied Products
Merchant Wholesalers (NAICS classification code 424690).\21\
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\21\ U.S. Small Business Administration, Table of size
standards, Version March 2023, Effective: March 17, 2023, https://www.sba.gov/sites/sbagov/files/2023-.
---------------------------------------------------------------------------
There are 8,804 small entities under 424690 Other Chemical and
Allied Products Merchant Wholesalers.\22\ The number of small entities
affected by this proposed rule is 0.19 percent of all the small
businesses in this industry.\23\ Based on these factors, DEA projects
that this rule, if promulgated, will not result in a significant
economic impact on a substantial number of small entities.
---------------------------------------------------------------------------
\22\ 2021 SUSB Annual Data Tables by Establishment Industry,
https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html, accessed: 1/9/2024.
\23\ Assuming all of the 17 non-registered suppliers are small
businesses, the percent of small businesses affected by this rule is
17/8,804 = 0.19%.
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Unfunded Mandates Reform Act of 1995
On the basis of information contained in the ``Regulatory
Flexibility Act'' section above, DEA has determined and certifies
pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1501 et seq., that this action would not result in any Federal mandate
that may result ``in the expenditure by State, local, and tribal
governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted for inflation) in any one year . . . .''
Therefore, neither a Small Government Agency Plan nor any other action
is required under provisions of UMRA.
Paperwork Reduction Act of 1995
This action does not impose any new or revised ``collection[s] of
information'' as defined by the Paperwork Reduction Act of 1995, 44
U.S.C. 3502(3).
List of Subjects in 21 CFR Part 1310
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, DEA proposes to amend 21 CFR part
1310 as follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES
0
1. The authority citation for part 1310 continues to read as follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
0
2. In Sec. 1310.02, add paragraph (a)(40) to read as follows:
Sec. 1310.02 Substances covered.
* * * * *
(a) * * *
* * * * *
(40) Propionyl chloride......................................... 8337
* * * * *
0
3. In Sec. 1310.04:
0
a. Redesignate paragraphs (g)(1)(xviii) and (g)(1)(xix) as paragraphs
(g)(1)(xix) and (g)(1)(xx), respectively; and
[[Page 23489]]
0
b. Add new paragraph (g)(1)(xviii) to read as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(g) * * *
(1) * * *
(xviii) Propionyl chloride
* * * * *
0
4. In Sec. 1310.09 add paragraph (t) to read as follows:
Sec. 1310.09 Temporary exemption from registration.
* * * * *
(t)(1) Each person required under 21 U.S.C. 822 and 21 U.S.C. 957
to obtain a registration to manufacture, distribute, import, or export
propionyl chloride, including regulated chemical mixtures pursuant to
Sec. 1310.12, is temporarily exempted from the registration
requirement, provided that DEA receives a properly completed
application for registration or application for exemption for a
chemical mixture containing propionyl chloride pursuant to Sec.
1310.13 on or before 30 days after the publication of a rule finalizing
this action. The exemption would remain in effect for each person who
has made such application until the Administration has approved or
denied that application. This exemption applies only to registration;
all other chemical control requirements set forth in the Act and parts
1309, 1310, 1313, and 1316 of this chapter remain in full force and
effect.
(2) Any person who manufactures, distributes, imports, or exports a
chemical mixture containing propionyl chloride whose application for
exemption is subsequently denied by DEA must obtain a registration with
DEA. A temporary exemption from the registration requirement will also
be provided for those persons whose application for exemption is
denied, provided that DEA receives a properly completed application for
registration on or before 30 days following the date of official DEA
notification that the application for exemption has been denied. The
temporary exemption for such persons would remain in effect until DEA
takes final action on their registration application.
0
5. In 1310.12, amend the table in paragraph (c) by adding in
alphabetical order an entry for ``propionyl chloride'' to read as
follows:
Sec. 1310.12 Exempt chemical mixtures.
* * * * *
(c) * * *
Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
DEA
chemical
code Concentration Special conditions
number
----------------------------------------------------------------------------------------------------------------
List I Chemicals
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Propionyl chloride...................... 8337 Not exempt at any Chemical mixtures containing
concentration. any amount of propionyl
chloride are not exempt.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
May 25, 2025, by Acting Administrator Robert J. Murphy. That document
with the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-09983 Filed 6-2-25; 8:45 am]
BILLING CODE 4410-09-P