[Federal Register Volume 90, Number 189 (Thursday, October 2, 2025)]
[Proposed Rules]
[Pages 47670-47677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19384]
[[Page 47670]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-1395]
Designation of P2P Methyl Glycidic Acid 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 the chemical 2-methyl-3-phenyloxirane-2-carboxylic acid (also known
as P2P methyl glycidic acid and BMK glycidic acid) and its esters, its
optical and geometric isomers, its salts, salts of its optical and
geometric isomers and its esters, and any combination thereof, whenever
the existence of such is possible, as a list I chemical under the
Controlled Substances Act (CSA). P2P methyl glycidic acid is important
to the manufacture of the schedule II controlled substances
phenylacetone (also known as phenyl-2-propanone or P2P),
methamphetamine, and amphetamine, and it is used in clandestine
laboratories to illicitly manufacture these controlled substances. If
finalized, this proposed rule would subject handlers of P2P methyl
glycidic acid to the chemical regulatory provisions of the CSA and its
implementing regulations. This rulemaking does not establish a
threshold for domestic and international transactions of P2P methyl
glycidic acid. As such, all transactions of P2P methyl glycidic acid,
regardless of size, shall be regulated. In addition, chemical mixtures
containing P2P methyl glycidic acid are not exempt from regulatory
requirements at any concentration. Therefore, all transactions of
chemical mixtures containing any quantity of P2P methyl glycidic acid
shall be regulated pursuant to the CSA. However, manufacturers may
submit an application for exemption for those mixtures that do not
qualify for automatic exemption.
DATES: Comments must be submitted electronically or postmarked on or
before November 3, 2025. Commenters should be aware that the electronic
Federal Docket Management System will not accept any comments after
11:59 p.m. Eastern Time on the last day of the comment period.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-1395'' 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 https://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, 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-1395.
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 proposed rule may be found in the docket
for this rulemaking at http://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 generally 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 defined as ``a chemical that is used in
manufacturing a controlled substance in violation of [the CSA] and is
important to the manufacture of the controlled substances.'' \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 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 notice of proposed rulemaking 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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In addition, the United States is a party to the 1988 United
Nations Convention Against Illicit Traffic in Narcotic Drugs and
Psychotropic Substances (1988 Convention), Dec. 20, 1988, 1582 U.N.T.S.
95. Under Article 12 of the 1988 Convention, when the United States
receives notification that a chemical has been added to Table I or
[[Page 47671]]
Table II of the 1988 Convention, the United States is required to take
measures it deems appropriate to monitor the manufacture and
distribution of that chemical within the United States and to prevent
its diversion, including measures related to international trade.
Background
By letter dated June 6, 2022, in accordance with Article 12,
paragraph 6 of the 1988 Convention, the Secretary-General of the United
Nations informed the United States that the chemicals P2P methyl
glycidic acid and specific esters of P2P methyl glycidic acid,
including their optical isomers, were added to Table I of the 1988
Convention. This letter was prompted by a decision of the United
Nations Commission on Narcotic Drugs (CND) to add P2P methyl glycidic
acid and specific esters of P2P methyl glycidic acid to Table I during
its 67th Session on March 19, 2024. As discussed above, the United
States is a party to the 1988 Convention and has certain obligations
pursuant to Article 12. By designating P2P methyl glycidic acid, as
well as its esters and their optical and geometric isomers, as list I
chemicals, the United States will fulfill its obligations under the
1988 Convention.
P2P methyl glycidic acid is used in, and is important to, the
manufacture of the schedule II substances phenylacetone (also known as
phenyl-2-propanone, P2P, or benzyl methyl ketone), methamphetamine, and
amphetamine. Throughout the 1970s, methamphetamine was illicitly
produced in the United States, primarily with the precursor chemical
P2P. In response to the illicit use of P2P, DEA controlled P2P as a
schedule II controlled substance in 1980 pursuant to the ``immediate
precursor'' provisions of the CSA, specifically 21 U.S.C. 811(e).\3\
Clandestine laboratory operators have circumvented this control by
developing a variety of synthetic methods for producing P2P.
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\3\ Schedules of Controlled Substances; Schedule II Placement of
Phenylacetone; (Phenyl-2-propanone, P2P, benzyl methyl ketone,
methyl benzyl ketone), 44 FR 71822 (Dec. 12, 1979).
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Congress and DEA responded by placing controls on certain chemicals
used in the illicit production of P2P, such as phenylacetic acid (and
its salts and esters), acetic anhydride, benzyl cyanide, benzaldehyde,
and nitroethane.4 5 However, clandestine laboratory
operators circumvented these controls by using alternative chemicals
that avoid the production of P2P--i.e., ephedrine and pseudoephedrine
for the production of methamphetamine, and phenylpropanolamine for the
production of amphetamine. This led Congress and DEA to place stringent
controls on the manufacture, distribution, importation, and exportation
of ephedrine (its salts, optical isomers, and salts of optical
isomers), pseudoephedrine, and phenylpropanolamine (controlled as list
I chemicals), and pharmaceutical products containing these chemicals
through the Combat Methamphetamine Epidemic Act of 2005 (Pub. L. 109-
117), the Methamphetamine Production Prevention Act of 2008 (Pub. L.
110-415), and the Combat Methamphetamine Act of 2010 (Pub. L. 111-
268).\6\
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\4\ On November 18, 1988, Congress enacted the Chemical
Diversion and Trafficking Act (Subtitle A of Title VI of Pub. L.
100-690).
\5\ Under 21 CFR 1310.02(a), benzaldehyde, benzyl cyanide,
nitroethane, and phenylacetic acid (including its salts and esters)
are list I chemicals. Under 21 CFR 1310.02(b), acetic anhydride is a
list II chemical.
\6\ DEA implemented the Combat Methamphetamine Epidemic Act of
2005, the Methamphetamine Production Prevention Act of 2008, and the
Combat Methamphetamine Enhancement Act of 2010 in a series of
interim and final rules. See Implementation of the Combat
Methamphetamine Epidemic Act of 2005; Notice of Transfers Following
Importation or Exportation, 72 FR 17401 (Apr. 9, 2007);
Implementation of the Combat Methamphetamine Epidemic Act of 2005;
Notice of Transfers Following Importation or Exportation; Temporary
Stay of Certain Provisions, 72 FR 28601 (May 22, 2007); Import and
Production Quotas for Certain List I Chemicals, 73 FR 73549 (Dec. 3,
2008); Combat Methamphetamine Epidemic Act of 2005: Fee for Self-
Certification for Regulated Sellers of Scheduled Listed Chemical
Products, 73 FR 79318 (Dec. 29, 2008); Registration Requirements for
Importers and Manufacturers of Prescription Drug Products Containing
Ephedrine, Pseudoephedrine, or Phenylpropanolamine, 75 FR 4973 (Feb.
1, 2010); Information on Foreign Chain of Distribution for
Ephedrine, Pseudoephedrine, and Phenylpropanolamine, 75 FR 10168
(Mar. 5, 2010); Removal of Thresholds for the List I Chemicals
Pseudoephedrine and Phenylpropanolamine, 75 FR 38915 (July 7, 2010);
Self-Certification and Employee Training of Mail-Order Distributors
of Scheduled Listed Chemical Products, 76 FR 20518 (Apr. 13, 2011);
Implementation of the Methamphetamine Production Prevention Act of
2008, 76 FR 74696 (Dec. 1, 2011).
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With the growing problem of illicit drug production and the issue
of precursor chemical controls gaining global attention, the
international community soon took similar measures. Article 12 of the
1988 Convention first established international controls on precursors.
Article 12 established two categories of controlled illicit drug
precursor substances: Table I and Table II.\7\ International efforts to
prevent the illicit production of amphetamine-type stimulants
(including amphetamine and methamphetamine), and international control
of precursors have since made significant progress.
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\7\ Table I and Table II are annexed to the Convention.
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Two international entities have played a crucial role in this
effort--the CND and the International Narcotics Control Board (INCB).
The CND meets annually to consider and adopt a range of decisions and
resolutions related to international drug control treaties, including
the 1988 Convention. The INCB is an independent quasi-judicial expert
body for the implementation of the international drug control treaties,
including the 1988 Convention. Previously, the CND has voted to include
methamphetamine and amphetamine precursor chemicals, including alpha-
phenylacetoacetonitrile (APAAN),\8\ 3,4-MDP2P methyl glycidicate, 3,4-
MDP2P glycidic acid, alpha-phenylacetoacetamied (APAA),\9\ and methyl
alpha-phenylacetoacetate (MAPA) under the 1988 Convention.\10\ The DEA
subsequently added these chemicals as list I chemicals to the CSA.\11\
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\8\ APAAN was added to Table I of the 1988 Convention at the
57th Session of the CND, which took place in March 2014.
\9\ APAA, 3,4-MDP2P glycidic acid, and 3,4-MDP2P methyl
glydicate were added to Table I of the 1988 Convention at the 62nd
Session of the CND
\10\ MAPA was added to Table I of the 1988 Convention at the
63rd Session of the CND.
\11\ Designation of Alpha-Phenylacetoacetonitrile (APAAN), a
Precursor Chemical Used in the Illicit Manufacture of Phenylacetone,
Methamphetamine, and Amphetamine, as a List I Chemical, 82 FR 32457
(July 14, 2017); Designation of Methyl alpha-phenylacetoacetate, a
Precursor Chemical Used in the Illicit Manufacture of Phenylacetone,
Methamphetamine, and Amphetamine, as a List I Chemical, 86 FR 64362
(Nov. 18, 2021); Designation of 3,4-MDP-2-P methyl glycidate (PMK
glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid),
and alpha-phenylacetoacetamide (APAA) as List I Chemicals, 86 FR
24703 (May 10, 2021); Designation of 3,4-MDP-2-P Methyl Glycidate
(PMK Glycidate), 3,4-MDP-2-P Methyl Glycidic Acid (PMK Glycidic
Acid), and Alpha-Phenylacetoacetamide (APAA) as List I Chemicals;
Correction, 86 FR 30169 (June 7, 2021).
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In response to domestic and international controls on amphetamine
and methamphetamine precursors, clandestine laboratory operators have
continued to explore alternate methods of making these illicit drugs,
including developing techniques to manufacture their own precursors and
diverting other precursors to produce these precursors. The INCB noted
the use of P2P methyl glycidic acid and its esters as precursors for
the production of P2P.\12\ The INCB began reporting the emergence of
P2P methyl glycidic acid in 2012, the emergence of methyl ester of P2P
methyl glycidic acid in 2016, and the emergence of ethyl ester of P2P
methyl
[[Page 47672]]
glycidic acid in 2023.\13\ P2P methyl glycidic acid does not have any
legitimate use, and it has not been widely traded through legitimate
channels. Clandestine laboratory operators currently use P2P methyl
glycidic acid to manufacture P2P, which they then convert to
methamphetamine and amphetamine.
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\12\ Statement by Professor Jallal Toufiq, President, INCB, 67th
Session of the, Mar. 19, 2024.
\13\ Id.
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P2P Methyl Glycidic Acid
P2P methyl glycidic acid is known as 2-methyl-3-phenyloxirane-2-
carboxylic acid; BMK glycidic acid; and CAS number: 25547-51-7. Since
2012, there have been 113 reports of the P2P methyl glycidic acid
sodium salt and 117 reports of P2P methyl glycidic acid through the
Precursors Incident Communication System (PICS).\14\ More than 47
metric tons of P2P methyl glycidic acid sodium salt and 51 metric tons
of P2P methyl glycidic acid were seized. Reports identified China as
the country of origin for 64 out of the 103 incidents (for example,
seizures, stopped shipments, diversions, etc.) where country of origin
was indicated in the incident report. The majority of the incidents
were reported in the Netherlands. Since November 2012, through PICS,
the INCB reported an increase in the frequency of seizures and amounts
seized reported for the sodium salt of P2P methyl glycidic acid.
Further, since 2022, INCB reported an increase in frequency and amounts
of incidents for P2P methyl glycidic acid, from 35 incidents in 2022 to
68 incidents in 2023.\15\
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\14\ PICS is a worldwide, real-time, on-line tool for
communication and information sharing between national authorities
on precursor incidents to include seizures, stopped shipments,
diversion and diversion attempts, illicit laboratories and
associated equipment. Queried July 1, 2024, https://pics.incb.org/.
\15\ Id.
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The INCB notes that P2P methyl glycidic acid, including its salts,
does not have any legitimate use.\16\ DEA has not identified any known
legitimate use for P2P methyl glycidic acid, other than in small
amounts for research, development, and laboratory analytical purposes.
Due to the lack of industrial uses of P2P methyl glycidic acid, the
chemical has not been widely available from legitimate chemical
suppliers. Since 2012, however, there have been large international
seizures of P2P methyl glycidic acid and its salts, primarily in
Europe, which suggest there is a ready supply of P2P methyl glycidic
acid from international chemical manufacturers. The only use for a
large quantity of P2P methyl glycidic acid of which DEA is aware is as
a primary precursor for conversion to P2P, and subsequent conversion to
amphetamine or methamphetamine.
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\16\ Statement by Professor Jallal Toufiq, President, INCB, 67th
Session of the CND (Mar. 19, 2024), at 2b.
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DEA has determined that P2P methyl glycidic acid is now readily
available from commercial chemical suppliers and has identified
potential suppliers in the United States, China, Austria, Hong Kong,
the Netherlands, Slovakia, Switzerland, and the United Kingdom.
Since 2016, there have been 12 reports through PICS of the methyl
ester of P2P methyl glycidic acid and four reports of the ethyl ester
of P2P methyl glycidic acid, totaling more than seven metric tons of
the methyl ester of P2P methyl glycidic acid seized and 986 kg of the
ethyl ester of P2P methyl glycidic acid seized.\17\ China was reported
as the alleged origin country for all incidents where the origin
country was reported. The majority of the incidents were reported in
the Netherlands. The INCB reported an increase in the frequency of
seizures and amounts seized reported through PICS since November
2016.\18\
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\17\ PICS system queried July 1, 2024, https://pics.incb.org/.
\18\ Id.
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DEA is concerned about the ease with which P2P methyl glycidic acid
and its esters serve as precursor chemicals for illicit controlled
substance production and with the international trafficking in this
chemical. The international community shares this concern. The INCB
found that P2P methyl glycidic acid and its esters are ``highly
suitable for the illicit manufacture of P2P.'' \19\ Based in part on
the findings of the INCB, and as noted above, the CND has added P2P
methyl glycidic acid and select esters of P2P methyl glycidic acid to
Table I of the 1988 Convention. Therefore, DEA is proposing the
designation of P2P methyl glycidic acid, including its optical and
geometric isomers, its esters, its salts, and salts of its optical and
geometric isomers and its esters, and any combination thereof, as list
I chemicals.
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\19\ Statement by Professor Jallal Toufiq, President,
International Narcotics Control Board, 67th Session of the
Commission on Narcotic Drugs, March 19, 2024, at 5.
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Proposed Designation of P2P Methyl Glycidic Acid and Its Esters, Its
Optical and Geometric Isomers, Its Salts, Salts of Its Optical and
Geometric Isomers and Its Esters, and Any Combination Thereof as List I
Chemicals
For the reasons discussed above, the Administrator of DEA finds
that P2P methyl glycidic acid is used in the manufacture of controlled
substances (i.e., schedule II substances P2P, methamphetamine, and
amphetamine) in violation of the CSA and is important to the
manufacture of these controlled substances. Clandestine laboratory
operators are using P2P methyl glycidic acid as a precursor material
for the illicit manufacture of P2P, methamphetamine, and amphetamine.
Therefore, the Administrator proposes the designation of P2P methyl
glycidic acid as a list I chemical.
If finalized, handlers of P2P methyl glycidic acid would become
subject to the chemical regulatory provisions of the CSA, including 21
CFR parts 1309, 1310, 1313, and 1316. Because there are no legitimate
industrial uses for P2P methyl glycidic acid, this action does not
propose the establishment of a threshold for domestic and import
transactions of P2P methyl glycidic acid in accordance with the
provisions of 21 CFR 1310.04(g). Therefore, DEA is proposing that all
P2P methyl glycidic acid transactions, regardless of size, would be
regulated transactions as defined in 21 CFR 1300.02(b). As such, if
finalized, all P2P methyl glycidic acid transactions would be subject
to recordkeeping, reporting, import and export controls, and other CSA
chemical regulatory requirements. In addition, each regulated bulk
manufacturer must submit manufacturing, inventory, and use data on an
annual basis, in accordance with 21 CFR 1310.05(d).
Chemical Mixtures of P2P Methyl Glycidic Acid
This rulemaking also proposes that chemical mixtures containing P2P
methyl glycidic acid would not be exempt from regulatory requirements
at any concentration, unless a manufacturer submits to DEA an
application for exemption of such chemical mixture, DEA accepts the
application for filing, and DEA exempts the chemical mixture in
accordance with 21 CFR 1310.13 (exemption of chemical mixtures by
application). Because there are no legitimate industrial uses for P2P
methyl glycidic acid, regulation of chemical mixtures containing any
amount of P2P methyl glycidic acid is necessary to prevent the illicit
extraction, isolation, and use of P2P methyl glycidic acid. Therefore,
all chemical mixtures containing any quantity of P2P methyl glycidic
acid would be subject to control under the CSA, unless a manufacturer
of P2P methyl glycidic acid is granted an exemption by the application
process in accordance with 21 CFR 1310.13. This rule proposes the
modification of the ``Table of Concentration Limits'' in 21 CFR
1310.12(c) to reflect the fact that chemical mixtures containing any
[[Page 47673]]
amount of P2P methyl glycidic acid are subject to CSA chemical control
provisions.
Application Process for Exemption of Chemical Mixtures
DEA has implemented an application process to exempt certain
chemical mixtures from the requirements of the CSA and its implementing
regulations.\20\ 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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\20\ 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
If finalized as proposed, the designation of P2P methyl glycidic
acid as a list I chemical would subject handlers (manufacturers,
distributors, importers, and exporters) and proposed handlers to all of
the regulatory controls and administrative, civil, and criminal
sanctions applicable to the manufacture, distribution, importing, and
exporting of a list I chemical. Upon the effective date of the final
rule, persons potentially handling P2P methyl glycidic acid, including
regulated chemical mixtures containing P2P methyl glycidic acid, would
be required to comply with the following list I chemical regulations:
1. Registration. Any person who handles (manufactures, distributes,
imports, or exports), or proposes to engage in such handling of, P2P
methyl glycidic acid or a chemical mixture containing P2P methyl
glycidic acid would be required to 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 P2P methyl glycidic acid.\21\
Further, a separate registration would be 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.\22\
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\21\ 21 CFR 1309.21.
\22\ 21 CFR 1309.23(a). See also 21 U.S.C. 822(e)(1) (separate
registration requirements pertaining to manufacturing or
distributing a list I chemical).
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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.\23\ Under DEA implementing regulations, the warehouse in
question would need to receive the list I chemical from a DEA
registrant and would only be able to distribute the list I chemical
back to the DEA registrant and registered location from which it was
received.\24\ A warehouse that distributes list I chemicals to persons
other than the registrant and registered location from which they were
obtained would be conducting distribution activities and so would be
required to register as such.
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\23\ 21 U.S.C. 822(c)(2), 957(b)(1)(B).
\24\ See 21 CFR 1309.23(b)(1).
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Upon publication of a final rule, any person manufacturing,
distributing, importing, or exporting P2P methyl glycidic acid or a
chemical mixture containing P2P methyl glycidic acid 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 P2P methyl glycidic acid, 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 P2P
methyl glycidic acid, provided that DEA receives a properly completed
application for registration on or before 30 days after publication of
a final rule implementing regulations regarding P2P methyl glycidic
acid. The temporary exemption for such persons would remain in effect
until DEA takes final action on their application for registration or
application for exemption of a chemical mixture.
The temporary exemption would apply solely to the registration
requirement; all other chemical control requirements, including
recordkeeping and reporting, would be applicable as of the effective
date of the final rule. Therefore, all transactions of P2P methyl
glycidic acid and chemical mixtures containing P2P methyl glycidic acid
would be regulated while an application for registration or exemption
is pending. 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 P2P methyl
glycidic acid, nor does it supersede State or local laws or
regulations. All handlers of P2P methyl glycidic acid 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 to DEA with respect to P2P methyl
glycidic acid pursuant to 21 U.S.C. 830(a) and (b)(1) and (2) and in
accordance with 21 CFR 1310.04 and 1310.05. Pursuant to 21 CFR 1310.04,
such a record must be made and maintained 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 would be
required to submit manufacturing, inventory, and use data on an annual
basis.\25\ Existing standard industry reports containing the required
information would be acceptable, provided the information is separate
or readily retrievable from the report.
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\25\ 21 CFR 1310.05(d).
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Regulated persons would need to comply with the CSA and its
implementing regulations requiring 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 would need to
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.\26\
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\26\ 21 U.S.C. 830(b); 21 CFR 1310.05(a), (b).
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3. Importation and Exportation. All importation and exportation of
P2P methyl glycidic acid would need to comply with 21 U.S.C. 957, 958,
and 971 and be in accordance with 21 CFR part 1313.
4. Security. All applicants and registrants would be required to
provide
[[Page 47674]]
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, would be 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.\27\
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\27\ 21 U.S.C. 880.
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6. Liability. Any activity involving P2P methyl glycidic acid 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 (Regulatory Review)
This proposed rule was developed in accordance with the principles
of Executive Orders (E.O.) 12866, 13563, and 14192. E.O. 12866 directs
agencies to assess all costs and benefits of available regulatory
alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health, and safety effects; distributive impacts;
and equity). E.O. 13563 is supplemental to and reaffirms the
principles, structures, and definitions governing regulatory review as
established in E.O. 12866. DEA scheduling actions are not subject to
E.O. 14192, Unleashing Prosperity Through Deregulation.
Executive Order 14294 specifies that all notices of proposed
rulemaking (NPRMs) and final rules published in the Federal Register,
the violation of which may constitute criminal regulatory offenses,
should include a statement identifying that the rule or proposed rule
is a criminal regulatory offense, the authorizing statute, and the mens
rea requirement for each element of the offense. This final rule does
not involve a criminal regulatory offense and thus E.O. 14294 does not
apply.
DEA has determined that this proposed rule is not a ``significant
regulatory action'' under E.O. 12866, section 3(f). Accordingly, this
rule was not reviewed by the Office of Information and Regulatory
Affairs.
If finalized as proposed, P2P methyl glycidic acid would be subject
to all of the regulatory controls as well as the administrative, civil,
and criminal sanctions applicable to the manufacturing, distributing,
importing, and exporting of list I chemicals. As discussed in this
notice, P2P methyl glycidic acid is used in, and is important to, the
illicit manufacture of the schedule II-controlled substances P2P,
methamphetamine, and amphetamine.
DEA has searched information in the public domain for any
legitimate uses of this chemical. Other than the small amounts for
research, development, and laboratory analytical purposes, DEA has not
documented any industrial use for P2P methyl glycidic acid except for
it being a chemical intermediate in the production of the schedule II
substances P2P, methamphetamine, and amphetamine. Based on the review
of the established aggregate production quota for P2P (100 grams for
2024), legal conversion of P2P methyl glycidic acid to P2P in the
United States, if it takes place at all, is limited to small, gram
quantities. Therefore, DEA concludes the vast majority of, if not all,
P2P methyl glycidic acid is used for the illicit manufacturing of P2P,
methamphetamine, and amphetamine.
DEA cannot rule out the possibility that minimal quantities of P2P
methyl glycidic acid are used for the manufacturing of legitimate P2P.
However, if there are any quantities of P2P methyl glycidic acid used
for the manufacturing of legitimate P2P, the quantities are believed to
be minimal. DEA welcomes any public comment on these quantities and
their economic significance.
DEA evaluated the costs and benefits of this proposed action.
Costs
DEA believes the market for P2P methyl glycidic acid for the
legitimate manufacturing of pharmaceutical amphetamine or
methamphetamine is minimal. As stated above, the only use for P2P
methyl glycidic acid of which DEA is aware is as a chemical
intermediate for the manufacture of P2P, methamphetamine, and
amphetamine. Any manufacturer, distributor, importer, or exporter of
P2P methyl glycidic acid for the production of legitimate P2P,
methamphetamine, and amphetamine, if they exist at all, would incur
costs if this proposed rule were finalized. The primary costs
associated with this proposed rule would be the annual registration
fees for manufacturers ($3,699) and for distributors, importers, and
exporters ($1,850). However, any manufacturer that uses P2P methyl
glycidic acid for legitimate P2P, methamphetamine, and amphetamine
production would already be registered with DEA and have all security
and other handling processes established because of the controls
already in place on P2P, methamphetamine, and amphetamine, resulting in
minimal cost to those entities. As there are different forms of
handling the scheduled substances versus the list I chemical
(distribution of P2P, methamphetamine, and amphetamine versus exporting
P2P methyl glycidic acid), this could require a separate registration
for the different handling of the substances. If an entity is already
registered to handle, manufacture, import, or export a scheduled
substance, the entity would not need an additional registration for the
list I chemical, provided it is handling the list I chemical in the
same manner that it is registered for the scheduled substance, or as a
coincident activity permitted by Sec. 1309.21(c). Even with the
possibility of these additional registrations, DEA believes that the
cost would be minimal.
DEA has identified nine domestic suppliers of P2P methyl glycidic
acid. It is difficult to estimate the quantity of P2P methyl glycidic
acid these suppliers distribute. Chemical distributors often have items
in their catalog while not actually having any material level of sales.
If this proposed rule is finalized, suppliers for the legitimate use of
P2P methyl glycidic acid, if any, are expected to choose the least-cost
option, which might include stopping the selling of minimal quantities
of P2P methyl glycidic acid, rather than incurring the registration
cost. Because DEA believes the quantities of P2P methyl glycidic acid
supplied for the legitimate manufacturing of P2P, methamphetamine, and
amphetamine are minimal, DEA estimates that the cost of foregone sales
is minimal; and thus, the cost of this proposed rule is minimal. DEA
welcomes any public comment regarding this estimate.
This analysis excludes consideration of any economic impact to
those businesses that facilitate the manufacture and distribution of
P2P methyl glycidic acid for the production of manufacturing illicit
P2P, methamphetamine, and amphetamine. As a law enforcement
organization and as a matter of principle, DEA believes considering the
economic utility of facilitating the manufacture of illicit P2P,
methamphetamine, and amphetamine would be improper.
Benefits
Controlling P2P methyl glycidic acid is expected to prevent,
curtail, and limit the unlawful manufacturing and
[[Page 47675]]
distribution of the controlled substances P2P, methamphetamine, and
amphetamine. As a list I chemical, handling of P2P methyl glycidic acid
would require registration with DEA, various controls, and monitoring
as required by the CSA. This proposed rule is also expected to assist
in preventing the possible theft or diversion of P2P methyl glycidic
acid from any legitimate firms. DEA also believes control is necessary
to prevent unscrupulous chemists from synthesizing P2P methyl glycidic
acid and selling it (as unregulated material) through the internet and
other channels, to individuals who may wish to acquire unregulated
chemical intermediates for the purpose of manufacturing illicit P2P,
methamphetamine, and amphetamine.
In summary, DEA conducted a qualitative analysis of costs and
benefits. DEA believes this proposed action, if finalized, would
minimize the diversion of P2P methyl glycidic acid. DEA believes the
market for P2P methyl glycidic acid for the legitimate manufacturing of
P2P, methamphetamine, and amphetamine is minimal. 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 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. It 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 (RFA),\28\ has reviewed this proposed 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 this rule
is finalized as proposed, P2P methyl glycidic acid would be subject to
all of the regulatory controls and administrative, civil, and criminal
sanctions applicable to the manufacture, distribution, importation, and
exportation of list I chemicals. P2P methyl glycidic acid is used in,
and is important to, the illicit manufacture of the schedule II-
controlled substances P2P, methamphetamine, and amphetamine. DEA has
not identified any legitimate industrial use for P2P methyl glycidic
acid, other than its role as a chemical intermediate in the production
of P2P, methamphetamine, and amphetamine. Based on the review of
established aggregate production quota for P2P, 100 grams for 2024,
legal conversion of P2P methyl glycidic acid in the United States, if
it takes place at all, is limited to small, gram quantities. Therefore,
DEA believes the vast majority, if not all, of P2P methyl glycidic acid
is used for the illicit manufacturing of P2P, methamphetamine, and
amphetamine. The primary costs associated with this proposed rule would
be the annual registration fees ($3,699 for manufacturers and $1,850
for distributors, importers, and exporters), but those registration
fees would only be applicable if they choose as part of their business
plan to continue to handle P2P methyl glycidic acid and that may not be
economically worthwhile if they only had been handling small amounts.
Additionally, any manufacturer that does use P2P methyl glycidic acid
for legitimate P2P, methamphetamine, and amphetamine production would
already be registered with DEA and have all security and other handling
processes in place, resulting in minimal cost.
---------------------------------------------------------------------------
\28\ 5 U.S.C. 601-612.
---------------------------------------------------------------------------
DEA has identified nine domestic suppliers of P2P methyl glycidic
acid. It is difficult to estimate the quantity of P2P methyl glycidic
acid these suppliers distribute. Chemical distributors often have items
in their catalog while not actually having any material level of sales.
Based on the review of established aggregate production quota for P2P
(100 grams for 2024), legal conversion of P2P methyl glycidic acid to
P2P in the United States is limited to small gram quantities. DEA
believes any quantity of sales of P2P methyl glycidic acid from these
distributors for legitimate P2P manufacturing is minimal. Therefore,
DEA estimates the cost of this rule on any affected small entity is
minimal. DEA welcomes any public comment regarding this estimate. 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.
Unfunded Mandates Reform Act of 1995
On the basis of information contained in the RFA 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 annually for
inflation) in any 1 year . . . .'' Therefore, neither a Small
Government Agency Plan nor any other action is required under
provisions of UMRA.
Paperwork Reduction Act
This proposed action does not impose a new collection of
information requirement under the Paperwork Reduction Act, 44 U.S.C.
3501-3521. This proposed action would not impose recordkeeping or
reporting requirements on State or local governments, individuals,
businesses, or organizations.
List of Subjects in 21 CFR Part 1310
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
Accordingly, for the reasons set forth in the preamble, 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 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) * * *
* * * * *
[[Page 47676]]
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(41) P2P methyl glycidic acid (2-methyl-3-phenyloxirane- 8526
2-carboxylic acid; BMK glycidic acid) and its esters,
its optical and geometric isomers, its salts, salts of
its optical and geometric isomers and its esters, and
any combination thereof, whenever the existence of such
is possible, including the following:
(i) Methyl ester of P2P methyl glycidic acid (methyl
2-methyl-3-phenyloxirane-2-carboxylate; P2P methyl
glycidicate; BMK methyl glycidicate)...............
(ii) Ethyl ester of P2P methyl glycidic acid (ethyl
2-methyl-3-phenyloxirane-2-carboxylate; P2P ethyl
glycidicate; BMK ethyl glycidicate)................
(iii) Propyl ester of P2P methyl glycidic acid
(propyl 2-methyl-3-phenyloxirane-2-carboxylate; P2P
propyl glycidicate; BMK propyl glycidicate)........
(iv) Isopropyl ester of P2P methyl glycidic acid
(isopropyl 2-methyl-3-phenyloxirane-2-carboxylate;
P2P isopropyl glycidicate; BMK isopropyl
glycidicate).......................................
(v) Butyl ester of P2P methyl glycidic acid (butyl 2-
methyl-3-phenyloxirane-2-carboxylate; P2P butyl
glycidicate; BMK butyl glycidicate)................
(vi) Isobutyl ester of P2P methyl glycidic acid
(isobutyl 2-methyl-3-phenyloxirane-2-carboxylate;
P2P isobutyl glycidicate; BMK isobutyl glycidicate)
(vii) sec-Butyl ester of P2P methyl glycidic acid
(sec-butyl 2-methyl-3-phenyloxirane-2-carboxylate;
P2P sec-butyl glycidicate; BMK sec-butyl
glycidicate........................................
(viii) tert-Butyl ester of P2P methyl glycidic acid
(tert-butyl 2-methyl-3-phenyloxirane-2-carboxylate;
P2P tert-butyl glycidicate; BMK tert-butyl
glycidicate........................................
------------------------------------------------------------------------
* * * * *
0
3. In Sec. 1310.04:
0
a. Redesignate paragraphs (g)(1)(xvi) through (xx) as paragraphs
(g)(1)(xvii) through (xxi), respectively; and
0
b. Add new paragraph (g)(1)(xvi).
The addition reads as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(g) * * *
(1) * * *
(xvi) P2P methyl glycidic acid (2-methyl-3-phenyloxirane-2-
carboxylic acid; BMK glycidic acid) and its esters, its optical and
geometric isomers, its salts, salts of its optical and geometric
isomers and its esters, and any combination thereof, whenever the
existence of such is possible
* * * * *
0
4. Amend Sec. 1310.09 by adding new 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 957 to obtain a
registration to manufacture, distribute, import, or export regulated
forms of P2P methyl glycidic acid (2-methyl-3-phenyloxirane-2-
carboxylic acid; also known as BMK glycidic acid) and its esters, its
optical and geometric isomers, its salts, salts of its optical and
geometric isomers and its esters, and any combination thereof, whenever
the existence of such is possible, including regulated chemical
mixtures pursuant to section 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 regulated forms of P2P methyl glycidic
acid pursuant to section 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 regulated forms of P2P methyl glycidic acid
(2-methyl-3-phenyloxirane-2-carboxylic acid; BMK glycidic acid) and its
esters, its optical and geometric isomers, its salts, salts of its
optical and geometric isomers and its esters, and any combination
thereof, whenever the existence of such is possible, whose application
for exemption is subsequently denied by DEA must obtain a registration
with DEA. A temporary exemption from the registration requirement would
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, the Table of Concentration Limits in paragraph (c)
is amended by adding an entry for P2P methyl glycidic acid (2-methyl-3-
phenyloxirane-2-carboxylic acid; BMK glycidic acid) and its esters, its
optical and geometric isomers, its salts, salts of its optical and
geometric isomers and its esters, and any combination thereof, whenever
the existence of such is possible in alphabetical order to read as
follows:
Sec. 1310.12 Exempt chemical mixtures.
* * * * *
(c) * * *
Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
DEA chemical
code No. Concentration Special conditions
----------------------------------------------------------------------------------------------------------------
* * * * * * *
P2P methyl glycidic acid (2-methyl-3- 8526 Not exempt at any Chemical mixtures
phenyloxirane-2-carboxylic acid; BMK concentration. containing any amount of
glycidic acid) and its esters, its P2P methyl glycidic acid
optical and geometric isomers, its are not exempt.
salts, salts of its optical and
geometric isomers and its esters, and
any combination thereof, whenever the
existence of such is possible.
[[Page 47677]]
* * * * * * *
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* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed
on September 30, 2025, by Administrator Terrance 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. 2025-19384 Filed 10-1-25; 8:45 am]
BILLING CODE 4410-09-P