Rule2026-04657
Designation of Propionyl Chloride as a List I Chemical
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 10, 2026
Effective
April 9, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration is finalizing the control of propionyl chloride as a list I chemical under the Controlled Substances Act (CSA). Propionyl chloride is used in the illicit manufacture of the controlled substances fentanyl, fentanyl analogues, and fentanyl-related substances, and it is important to the manufacture of these substances. This final rule subjects handlers of propionyl chloride to the chemical regulatory provisions of the CSA and its implementing regulations.
Full Text
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<title>Federal Register, Volume 91 Issue 46 (Tuesday, March 10, 2026)</title>
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[Federal Register Volume 91, Number 46 (Tuesday, March 10, 2026)]
[Rules and Regulations]
[Pages 11450-11456]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-04657]
[[Page 11450]]
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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: Final rule.
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SUMMARY: The Drug Enforcement Administration is finalizing the control
of propionyl chloride as a list I chemical under the Controlled
Substances Act (CSA). Propionyl chloride is used in the illicit
manufacture of the controlled substances fentanyl, fentanyl analogues,
and fentanyl-related substances, and it is important to the manufacture
of these substances. This final rule subjects handlers of propionyl
chloride to the chemical regulatory provisions of the CSA and its
implementing regulations.
DATES: This rulemaking will become effective on April 9, 2026. Persons
seeking registration must apply before April 9, 2026 to continue their
business pending final action by DEA on their application.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: The Drug Enforcement Administration (DEA) is
extremely concerned with the recent increase in the illicit manufacture
and distribution of fentanyl. Therefore, on October 12, 2023, DEA
published an Advanced Notice of Proposed Rulemaking (ANPRM) soliciting
comments on the legitimate use of propionyl chloride in industry. On
June 3, 2025, DEA published a Notice of Proposed Rulemaking (NPRM) to
control the precursor chemical propionyl chloride as a list I
chemical.\1\ This rulemaking finalizes that NPRM.
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\1\ Designation of Propionyl Chloride as a List I Chemical, 90
FR 23483 (June 3, 2025).
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This action subjects handlers of propionyl chloride to the chemical
regulatory provisions of the Controlled Substances Act (CSA) and its
implementing regulations. This rulemaking does not establish a
threshold for domestic and international transactions of propionyl
chloride. As such, all transactions involving propionyl chloride,
regardless of size, shall be regulated and are subject to control under
the CSA. 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.
Legal Authority
The CSA gives the Attorney General the authority to specify, by
regulation, chemicals as list I chemicals.\2\ 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 substance.'' \3\ 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 Federal Register following a published
NPRM with at least 30 days for public comments.
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\2\ 21 U.S.C. 802(34).
\3\ 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. Therefore, due to
its currently accepted medical use in treatment in the United States,
DEA controls fentanyl as a schedule II controlled substance despite its
high potential for abuse and the possibility that abuse may lead to
severe psychological or physical dependence.\4\ Moreover, there are a
substantial number of fentanyl analogues and fentanyl-related
substances that are being distributed on the illicit drug market.
Illicit manufacturers attempt to utilize unregulated precursor
chemicals to evade law enforcement detection and precursor chemical
controls 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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\4\ 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.\5\
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\5\ National Drug Threat Assessment 2025, Drug Enforcement
Administration, May 2025.
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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, with a slight decrease
in 2023. 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,\6\ drug overdose deaths involving synthetic
opioids (excluding methadone) in the United States increased from
36,359 in 2019 to 56,516 in 2020; 70,601 in 2021; and 73,838 in 2022
with only a slight decrease to 72,776 in 2023; and provisionally 48,018
in 2024.\7\ While the total number of overdose deaths have been
declining (overdose deaths peaked in 2022 with 107,941deaths; then
decreased to
[[Page 11451]]
105,007 in 2023; and provisionally decreased to 79,848 in 2024),
opioids continue to be the drug class associated with the largest
number of overdose deaths. Overdose fatalities involving synthetic
opioids coincides with a dramatic increase in law enforcement
encounters of fentanyl, fentanyl analogues, and fentanyl-related
substances. According to the National Forensic Laboratory Information
System (NFLIS-Drug),\8\ reports from forensic laboratories of drug
items containing fentanyl, fentanyl analogues, and fentanyl-related
substances increased dramatically since 2016, as shown in Table 1 (2025
data is still being reported).
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\6\ 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, 2018-2024, and from provisional data
for years 2024-2025, as compiled from data provided by the 57 vital
statistics jurisdictions through the Vital Statistics Cooperative
Program. Accessed at <a href="http://wonder.cdc.gov/mcd-icd10-provisional.html">http://wonder.cdc.gov/mcd-icd10-provisional.html</a> on January 27, 2026.
\7\ Provisional counts in CDC Wonder are the counts of overdose
deaths prior to being finalized for a calendar year. Provisional
counts of deaths are underestimated relative to final counts. This
is due to the many steps involved in reporting death certificate
data. When a death occurs, a certifier (e.g. physician, medical
examiner or coroner) will complete the death certificate with the
underlying cause of death and any contributing causes of death. In
some cases, laboratory tests or autopsy results may be required to
determine the cause of death.
\8\ The National Forensic Laboratory Information System (NFLIS)
represents an important resource in monitoring illicit drug
trafficking, including the diversion of legally manufactured
pharmaceuticals into illegal markets. 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 Schedules of
Controlled Substances: Placement of Carisoprodol Into Schedule IV,
76 FR 77330, 77332 (Dec. 12, 2011). NFLIS-Drug data was queried on
January 8, 2026; *2025 data is still reporting.
Table 1--Annual Reports of Fentanyl and Select Fentanyl Analogues and Fentanyl-Related Substances Identified in Drug Encounters
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Year 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 *
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Annual Fentanyl Reports....................................... 37,158 61,648 90,017 108,231 126,483 166,718 177,227 183,009 154,015 89,003
Annual Reports of select fentanyl analogues and fentanyl- 7,625 22,072 16,163 20,935 8,005 26,691 30,978 21,511 20,205 7,616
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 one chemical reaction or 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); \9\ N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide
(benzylfentanyl) and its salts; \10\ N-phenylpiperidin-4-amine (4-
anilinopiperidine) including its amides, halides, carbamates, salts,
and any combination thereof; \11\ and 4-piperidone (piperidin-4-one)
including its acetals, amides, carbamates, salts, and salts of acetals,
amides, and carbamates, and any combination thereof \12\ as list I
chemicals. DEA also controls 4-anilino-N-phenethylpiperidine (ANPP)
\13\ and N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl) \14\ as
schedule II immediate precursors to fentanyl under the CSA.
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\9\ Control of a Chemical Precursor Used in the Illicit
Manufacture of Fentanyl as a List I Chemical, 72 FR 20039 (Apr. 23,
2007).
\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).
\11\ 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).
\12\ Designation of 4-Piperidone as a List I Chemical, 88 FR
21902-21910 (Apr. 12, 2023).
\13\ Control of Immediate Precursor Used in the Illicit
Manufacture of Fentanyl as a Schedule II Controlled Substance, 75 FR
37295 (June 29, 2010).
\14\ 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,\15\ is synthesized by
reacting propionyl chloride with 4-anilino-1-benzylpiperidine, which is
then converted to norfentanyl, the schedule II immediate precursor to
fentanyl in this synthetic pathway.\16\ 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,\17\ the
schedule II immediate precursor to fentanyl 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,\18\ which serves as an alternative precursor chemical to NPP, a
list I chemical, in the synthesis of ANPP, a schedule II immediate
precursor to fentanyl 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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\15\ See footnote 10.
\16\ See footnote 13.
\17\ See footnote 12.
\18\ 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
[[Page 11452]]
is readily available from chemical suppliers, and it can be easily used
in many known synthetic pathways used for the illicit manufacture of
fentanyl, fentanyl analogues, and fentanyl-related substances.
Comments Received in Response to the NPRM
In response to the June 3, 2025 NPRM, DEA received one comment in
opposition to the control of propionyl chloride as a list I chemical.
The commenter cited four areas of concern relating to the control of
propionyl chloride.
Comment: The first concern the commenter raised was that
controlling propionyl chloride as a list I chemical would
disproportionately harm legitimate industries, specifically the
pharmaceutical industry, the agrochemical industry, and other
industries using it in their applications. The commenter mentioned
propionyl chloride is used to synthesize vital medicines, it is an
intermediate for crop protection agents, and can be used to produce
dyes, textiles, and other products. The commenter also mentioned that
even though norfentanyl is an immediate precursor to fentanyl, it was
only controlled as a list II chemical, which is in stark contrast to
what is being proposed for the control of propionyl chloride in list I.
DEA Response: DEA appreciates the commenter's concern for the
industries that may be impacted by the control of propionyl chloride as
a list I chemical. To properly assess the potential effects of
controlling propionyl chloride, DEA published both an ANPRM and the
NPRM. These two publications requested information from industries and
allowed for any interested persons to comment with their concerns.
DEA is aware that propionyl chloride may be used as an intermediate
in several industrial processes, including but not limited to the
synthesis of dyes, pharmaceuticals (including fentanyl), and
agricultural products. Designating propionyl chloride as a list I
chemical does not preclude the use of propionyl chloride for end users
(i.e., those using it as an intermediate chemical or in chemical
synthesis). DEA registration for list I chemicals is only for those who
are manufacturing, distributing, importing, or exporting list I
chemicals. It is not required for those doing synthesis, unless they
are also participating in one of the forementioned activities that
require registration. Therefore, unless the user is also manufacturing,
distributing, importing, or exporting propionyl chloride, this action
will not affect industries that may be using propionyl chloride as an
intermediate in synthesis. Any potential burdens on industry are
outweighed by the public health and public safety benefits of listing
propionyl chloride.
In regard to controlling propionyl chloride in list I compared to
the placement of norfentanyl, norfentanyl is controlled in schedule II
of the CSA as an immediate precursor to fentanyl. Requirements for
controlled substances in schedules I-V of the CSA,\19\ including
immediate precursors in schedule II, are more restrictive than that of
chemicals listed in list I or list II of CSA.\20\ Controlling propionyl
chloride in list I would only require those who manufacture,
distribute, import, or export propionyl chloride to register with DEA
and maintain records. End users of propionyl chloride, unless they are
engaged in one of the previous mentioned activities, would not be
required to register with DEA. Therefore, industries who may be using
propionyl chloride in legitimate industries will still be able to use
propionyl chloride for research and industrial purposes and may not be
required to register with DEA for the use of this chemical.
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\19\ 21 CFR 1301-1308; 21 CFR 1311-1312.
\20\ 21 CFR 1309-1310; 21 CFR 1313.
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Comment: The commenter next voiced concern that this action exceeds
DEA's authority and harms the U.S. economy. The commenter concluded
that the United States is a net importer of propionyl chloride, and,
therefore, DEA is attempting to regulate foreign commerce, which is an
authority delegated exclusively to Congress.
DEA Response: DEA appreciates the commenter's concerns. In the CSA,
Congress authorized the Attorney General to specify, by regulation,
chemicals as list I chemicals.\21\ This authority has been delegated to
the Administrator of DEA,\22\ and DEA regulations address how DEA may
add and regulate a chemical as a list I chemical, including the
importation of that chemical.\23\ Listing a chemical in the CSA does
not regulate foreign commerce.
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\21\ 21 U.S.C. 802(34).
\22\ 28 CFR 0.100(b).
\23\ See, e.g., 21 CFR 1310.02(c) (adding a chemical); 21 CFR
1313.12-.17 (importation of listed chemicals).
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Comment: The commenter claims that DEA's regulatory strategy is
ineffective and counterproductive.
DEA Response: DEA is concerned with the abuse of illicitly
manufactured fentanyl in the United States and believes this rule will
help control the illicit manufacture of fentanyl.
Comment: Finally, the commenter claims that DEA's history
undermines trust in its motives. Specifically, the commenter stated
that DEA has a long and documented history of misconduct that calls
into question its judgment and motives.
DEA Response: The comment about having trust in DEA's motives is
outside the scope of this rule.
Chemical Mixtures of Propionyl Chloride
Under the rulemaking, chemical mixtures containing propionyl
chloride are not 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 rule
modifies 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.
Application Process for Exemption of Chemical Mixtures
DEA has implemented an application process to exempt mixtures from
the requirements of the CSA and its implementing regulations.\24\
Manufacturers may apply for an automatic exemption for those mixtures
that do not meet the criteria set forth in 21 CFR 1310.12(d). Pursuant
to 21 CFR 1310.13(a), DEA may grant an exemption of a chemical mixture,
by publishing a final rule in the Federal Register, if DEA determines
that: (1) the mixture is formulated in such a way that it cannot be
easily used in the illicit production of a controlled substance, and
(2) the listed chemical or chemicals cannot be readily recovered.
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\24\ 21 CFR 1310.13 specifies that this chemical mixture is a
chemical mixture consisting of two or more chemical components, at
least one of which is a list I or list II chemical. See also 21 CFR
1300.02 (defining the term ``chemical mixture'').
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Requirements for Handling List I Chemicals
This final rule subjects propionyl chloride to all the regulatory
controls and administrative, civil, and criminal sanctions applicable
to the manufacture, distribution, importing, and exporting of list I
chemicals. Upon the effective date of this rule, persons handling
propionyl
[[Page 11453]]
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.\25\ 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.\26\
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\25\ 21 CFR 1309.21.
\26\ 21 U.S.C. 822(e)(1) and 21 CFR 1309.23(a).
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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 which they were obtained is conducting
distribution activities and is required to register as such.\27\
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\27\ 21 U.S.C. 822(a)(1).
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Upon the effective date of this final rule, any person
manufacturing, distributing, importing, or exporting propionyl chloride
or a chemical mixture containing propionyl chloride will 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 establishing 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 the effective date of this final
rule. 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, will be 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 must 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 must submit
manufacturing, inventory, and use data on an annual basis. Existing
standard industry reports containing the required information are
acceptable, provided the information is separate or readily retrievable
from the report.\28\
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\28\ 21 CFR 1310.05(d).
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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 a 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.\29\
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\29\ 21 U.S.C. 830(b) and 21 CFR 1310.05(a) and (b).
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3. Importation and Exportation. All importation and exportation of
propionyl chloride or a chemical mixture containing propionyl chloride
must 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 must 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, 13563, 14192, and 14294
This final rule has been drafted and reviewed in accordance with
Executive Order (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 either E.O.
14192, Unleashing Prosperity Through Deregulation, or E.O. 14294,
Fighting Overcriminalization in Federal Regulations.
Section 3(f) of E.O. 12866 classifies a ``significant regulatory
action,'' requiring review by the Office of Management and Budget
(OMB), as any regulatory action that is likely to result in a rule that
may: (1) have an annual effect on the economy of $100 million or more
or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or state, local, or tribal
[[Page 11454]]
governments or communities; (2) create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the E.O.
DEA finds that propionyl chloride is used in the illicit
manufacture of the controlled substances of 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. This
final rule subjects handlers of propionyl chloride to the chemical
regulatory provisions of the CSA and its implementing regulations. This
final rule 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.
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.
DEA evaluated the cost of this final rule. Due to many unknowns,
DEA is unable to provide an estimated cost of this final rule; however,
based on DEA's analysis, the Office of Information and Regulatory
Affairs has determined that this final rule is not economically
significant under section 3(f)(1) of E.O. 12866.
Costs
Propionyl chloride is used for the legitimate manufacturing of
pharmaceutical fentanyl as well as clandestinely synthesized illicit
fentanyl. DEA has searched information in the public domain for
legitimate uses of propionyl chloride and has documented that propionyl
chloride may be used as an intermediary chemical in several industries,
including the production of fentanyl. However, this rule would only
impose regulations on those who manufacture, distribute, import, or
export propionyl chloride and not end users who are using the chemical
as an intermediate.
The primary costs associated with this 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 to be much smaller compared
to the registered distributors. 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 will be small; and thus, the cost of this rule is
minimal. DEA requested public comments regarding this estimate, however
no public comment was received during the notice and comment period
regarding the costs to industry.
Benefits
Controlling propionyl chloride is expected to prevent, curtail, and
limit the unlawful manufacture and distribution of the controlled
substance, fentanyl, as well as fentanyl analogues and fentanyl-related
substances. As a list I chemical, handling of propionyl chloride
requires registration with DEA and various controls and monitoring as
required by the CSA. This rule is also expected to assist in preventing
the possible theft or diversion of propionyl chloride from any
legitimate firms. DEA also believes control is necessary to prevent
unscrupulous chemists from synthesizing propionyl chloride and selling
it (as an unregulated material) through the internet and other
channels, to individuals who may wish to acquire unregulated
intermediary chemicals for the purpose of illicitly manufacturing
fentanyl, fentanyl analogues, and fentanyl-related substances.
In summary, DEA conducted a qualitative analysis of this final
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 rulemaking 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 rulemaking does not have federalism implications warranting
the application of E.O. 13132. The final 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 rulemaking does not have tribal implications warranting the
application of E.O. 13175. This final 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 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, with this rulemaking, 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. This rulemaking 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
[[Page 11455]]
Allied Products Merchant Wholesalers (NAICS classification code
424690).\30\
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\30\ U.S. Small Business Administration, Table of size
standards, Version March 2023, Effective: March 17, 2023, <a href="https://www.sba.gov/sites/sbagov/files/2023-">https://www.sba.gov/sites/sbagov/files/2023-</a>.
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There are 8,804 small entities under 424690 Other Chemical and
Allied Products Merchant Wholesalers.\31\ The number of small entities
affected by this final rule is 0.19 percent of all the small businesses
in this industry.\32\ Based on these factors, DEA projects that this
rule will not result in a significant economic impact on a substantial
number of small entities.
---------------------------------------------------------------------------
\31\ 2021 SUSB Annual Data Tables by Establishment Industry,
<a href="https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html">https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html</a>, accessed: 1/9/2024.
\32\ 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%.
---------------------------------------------------------------------------
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 a new collection of information
requirement under the Paperwork Reduction Act of 1995.\33\ This action
would not impose recordkeeping or reporting requirements on state or
local governments, individuals, businesses, or organizations. However,
this rule requires compliance with the following existing OMB
collections: 1117-0003, 1117-0004, 1117-0006, 1117-0008, 1117-0009,
1117-0010, 1117-0012, 1117-0014, 1117-0021, 1117-0023, 1117-0029, and
1117-0056. An agency may not conduct or sponsor, and a person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number.
---------------------------------------------------------------------------
\33\ 44 U.S.C. 3501 through 3521.
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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 amends 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 21 CFR 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)(41) to read as follows:
Sec. 1310.02 Substances covered.
* * * * *
(a) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * *
(41) Propionyl chloride......................................... 8337
------------------------------------------------------------------------
* * * * *
0
3. In Sec. 1310.04:
0
a. Redesignate paragraphs (g)(1)(xix) and (g)(1)(xx) as paragraphs
(g)(1)(xx) and (g)(1)(xxi), respectively; and
0
b. Add new paragraph (g)(1)(xix).
The addition reads as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(g) * * *
(1) * * *
(xix) 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 Sec. 1310.12, table in paragraph (c) is amended 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 Concentration Special conditions
code No.
----------------------------------------------------------------------------------------------------------------
List I Chemicals
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Propionyl chloride...................... 8337 Not exempt at any Chemical mixtures containing
concentration. any amount of propionyl
chloride are not exempt.
[[Page 11456]]
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
February 25, 2026, by Administrator Terrance C. Cole. 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. 2026-04657 Filed 3-9-26; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on March 10, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.