DEA Designates P2P Methyl Glycidic Acid as List I Chemical

Content

ACTION:

Final rule.

SUMMARY:

The Drug Enforcement Administration is finalizing the control of 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 used in the illicit manufacture of
the controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine, and it
is important to the manufacture of these substances. This final rule subjects handlers of P2P methyl glycidic acid to the
chemical regulatory provisions of the CSA and its implementing regulations.

DATES:

This rulemaking will become effective on May 4, 2026. Persons seeking registration must apply on or before May 4, 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:

This final rule designates 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, as a list I chemical. This action subjects handlers of P2P methyl glycidic acid 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 P2P methyl glycidic acid. As such, all transactions involving P2P methyl glycidic
acid, regardless of size, shall be regulated and are subject to control under the CSA. 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.

Legal Authority

The 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's regulations set
forth the process by which DEA may add a chemical as a listed chemical. As set forth in 21 CFR 1310.02(c), the agency may
do so by publishing a final rule in the
Federal Register
following a published notice of proposed rulemaking (NPRM) with at least 30 days for public comments.

In addition, the United States is a party to the 1988 United Nations Convention Against Illicit Traffic in Narcotic Drugs
and Psychotropic Substances (1988 Convention), Dec. 20, 1988, 1582 U.N.T.S. 95. Under Article 12 of the 1988 Convention, when
the United States receives notification that a chemical has been added to Table I or Table II of the 1988 Convention, the
United States is required to take measures it deems appropriate to monitor the manufacture and distribution of that chemical
within the United States and to prevent its diversion, including measures related to international trade.

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 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.

On October 2, 2025, DEA published an NPRM to designate P2P methyl glycidic acid, including its esters, its optical and geometric
isomers, its salts, salts of its optical and geometric isomers and its esters, and any combination thereof, as a list I chemical
under the CSA. (3) In the NPRM, the Administrator found that 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. P2P methyl glycidic acid does not have any legitimate use, and it has not been widely traded through legitimate
channels. Clandestine laboratory operators have circumvented the schedule II controls on P2P by developing a variety of synthetic
methods for producing P2P, which they then convert to methamphetamine and amphetamine. (4)

Comments Received

As part of the NPRM published on October 2, 2025, DEA solicited comments regarding this rulemaking. (5) In response to the NPRM, DEA received three comments. One commenter was in support of controlling P2P methyl glycidic acid
as a list I chemical. One commenter supported the control of P2P methyl glycidic acid; however, it requested that DEA correct
what it believed to be procedural deficiencies to ensure the rule is legally sustainable and complete. One commenter submitted
a response that was outside the scope of the action.

Comment in support of rulemaking: One commenter stated that it supported regulating P2P methyl glycidic acid and encouraged DEA to continue to monitor international
discoveries of alternative precursors to highly marketable illicit substances.

DEA Response: DEA agrees with the comment in support of controlling P2P methyl glycidic acid as a list I chemical. DEA is concerned with
the abuse of illicitly manufactured methamphetamine and amphetamine in the United States and believes this rule will help
to control the illicit manufacture of these substances. DEA also agrees that the illicit manufacture of methamphetamine and
other drugs is a global challenge and necessitates cooperation with international partners, including compliance with international
treaties.

Comment raising procedural requests: One commenter agreed with the proposal and targeting against chemical diversion, but it requested that DEA fix problems in
the proposed rule by adhering to the following procedures: (1) using the Administrative Procedure Act (APA) correctly for
public input; (2) analyzing impacts on small businesses under the Regulatory Flexibility Act (RFA); (3) justifying why the
rule is not a “significant regulatory action” as defined by Executive Order (E.O.) 12866; and (4) complying with information
collection under the Paperwork Reduction Act (PRA) because a new listed chemical expands the number of respondents subject
to existing collections of information.

DEA Response: DEA appreciates the comment. First, DEA followed standard rulemaking process as set forth in 21 CFR 1310.02(c) and (h), which
involved publishing an NPRM in the
Federal Register
and allowing a 30-day period for interested persons to file written comments. DEA did not rely on the APA's “good cause” exception
under 5 U.S.C. 553(b)(B) or (d)(3) to forego notice-and-comment rulemaking in this instance. On the contrary, the agency provided
a 30-day public comment period, (6) consistent with both DEA regulations and APA requirements. (7) Because notice and an opportunity for public participation were afforded, the rulemaking process complied with the APA's procedural
requirements.

Second, in regard to the RFA, DEA certified in the NPRM that the rule will not result in a significant economic impact on
a substantial number of small entities and provided the factual basis for the certification. (8) For example, DEA explained that there are nine suppliers of P2P Methyl Glycidic Acid which account for far less than a substantial
number (approximately 0.07 percent) of small businesses in industries likely to represent such suppliers, i.e., 325412—Pharmaceutical Preparation Manufacturing, 424210—Drugs and Druggists' Sundries Merchant Wholesalers, and 424690—Other
Chemical and Allied Products Merchant Wholesalers. Furthermore, the NPRM adequately explained that the cost of this rule on
any affected small entity is minimal. (9)

Third, the Office of Information and Regulatory Affairs determined that the rule would not be a “significant regulatory action”
as defined under section 3(f) of E.O. 12866, including section 3(f)(1), and, therefore, the rule did not require review by
the Office of Management and Budget (OMB).

Finally, the PRA distinguishes between the creation of a new information collection and changes to the scope or scale of an
already approved collection. An increase in the number of respondents associated with an existing, OMB-approved information
collection does not, by itself, constitute a “new collection of information” under the PRA. This rule requires compliance
with the following existing OMB collections: 1117-0023 and 1117-0029.

Comment that was not related to this rulemaking: One commenter stated that it supported placing MDMB-4en-PINACA in schedule I due to the harm associated with that substance
and the public health risk.

DEA Response: While DEA appreciates the comment, it is outside the scope of the current rulemaking action; therefore, this comment was not
considered.

Designation of P2P Methyl Glycidic Acid as a List I Chemical

For the reasons discussed in the NPRM and reiterated in the above background section, the Administrator finds that P2P methyl
glycidic acid is used in the manufacture of controlled substances in violation of the CSA and is important to the manufacture
of these controlled substances. Therefore, the Administrator designates P2P methyl glycidic acid, including its esters, its
optical and geometric isomers, its salts, salts of its optical and geometric isomers and its esters, and any combination

  thereof, and its optical isomers as a list I chemical.

Chemical Mixtures of P2P Methyl Glycidic Acid

Pursuant to this final rule, chemical mixtures containing P2P methyl glycidic acid are not 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 are
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 finalizes the modification of the “Table of Concentration Limits” in
21 CFR 1310.12(c) to reflect the fact that chemical mixtures containing any 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. (10) 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.

Requirements for Handling List I Chemicals

The designation of P2P methyl glycidic acid as a list I chemical subjects 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 handling P2P methyl glycidic acid, including regulated chemical mixtures containing P2P methyl glycidic acid, are
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 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 P2P methyl glycidic acid. (11) 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. (12)

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. (13) 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. (14) 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.

Upon the effective date of this final rule, any person manufacturing, distributing, importing, or exporting P2P methyl glycidic
acid or a chemical mixture containing P2P methyl glycidic acid 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 P2P methyl glycidic acid, DEA is establishing 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 May 4, 2026. 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 would apply solely to the registration requirement; all other chemical control requirements, including
recordkeeping and reporting, will become effective on the effective date of the final rule. Therefore, all transactions of
P2P methyl glycidic acid and chemical mixtures containing P2P methyl glycidic acid will 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.

1. Records and Reports. Every DEA registrant must 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, 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. (15) Existing standard industry reports containing the required information are acceptable, provided the information is separate
or readily retrievable from the report.

Regulated persons must 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 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. [(16)]()

1. Importation and Exportation. All importation and exportation of P2P methyl glycidic acid must comply with 21 U.S.C. 957, 958, and 971 and in accordance
   with 21 CFR part 1313.

2. 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.

3. 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. (17)

4. Liability. Any activity involving P2P methyl glycidic acid not authorized by, or in violation of, the CSA is 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 final rule was drafted and reviewed in accordance with E.O. 12866, “Regulatory Planning and Review,” section 1(b), Principles
of Regulation, and E.O. 13563, “Improving Regulation and Regulatory Review,” section 1(b), General Principles of Regulation.
DEA scheduling actions are not subject to either E.O. 14192, Unleashing Prosperity Through Deregulation, or E.O. 14294, Fighting
Overcriminalization in Federal Regulations.

E.O. 12866 classifies a “significant regulatory action,” requiring review by 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 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.

The Office of Information and Regulatory Affairs has determined that this 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.

As finalized, P2P methyl glycidic acid is 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. 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 that 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 evaluated the costs and benefits of this action. Due to many unknowns, DEA is unable to provide an estimated cost of this
rule; however, DEA believes the economic effects will not be significant and will be far below the E.O. 12866 section 3(f)(1)
threshold.

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 21 CFR 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. As 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 requested public comments regarding this estimate, however no public comment was received during the
  notice and comment period regarding the costs to industry.

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 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 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 action will 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 rulemaking 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 rulemaking does not have federalism implications warranting the application of E.O. 13132. The 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 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 (RFA), (18) 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, P2P methyl glycidic acid and criminal mixtures containing P2P methyl glycidic acid
are 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 rule is the annual registration fees ($3,699 for manufacturers and $1,850 for distributors,
importers, and exporters), but those registration fees are only 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.

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. Based on these factors, DEA projects that this rule 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 rule requires compliance with the following existing OMB collections: 1117-0023 and 1117-0029. 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.

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 amends 21 CFR part 1310 as follows:

PART 1310—RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES

Regulatory Text 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.

1. In § 1310.02 add paragraph (a)(42) to read as follows:

§ 1310.02 Substances covered.

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(a) * * *

| | |
| --- | --- |
| | |
|                                                       * | |
| (42) 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, including the following: | 8526 |
| (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 | |

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1. In § 1310.04:

a. Redesignate paragraphs (g)(1)(xvi) through (xxi) as paragraphs (g)(1)(xvii) through (xxii), respectively; and

b. Add new paragraph (g)(1)(xvi).

The addition reads as follows:

§ 1310.04 Maintenance of records.

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(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

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1. Amend § 1310.09 by adding new paragraph (u) to read as follows:

§ 1310.09 Temporary exemption from registration.

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(u)(1) Each person required under 21 U.S.C. 822 and 957 to obtain a registration to manufacture, distribute, import, or export
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 § 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 P2P methyl glycidic acid pursuant to § 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 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.

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1. In § 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:

§ 1310.12 Exempt chemical mixtures.

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(c) * * *

| | DEA chemical
code No. | Concentration | Special conditions |
| --- | --- | --- | --- |
| | | | |
|                                                       * | | | |
| 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 | 8526 | Not exempt at any concentration | Chemical mixtures containing any amount of P2P methyl glycidic acid are not exempt. |
| | | | |
|                                                       * | | | |

---

Signing Authority

This document of the Drug Enforcement Administration was signed on March 28, 2026, by Assistant Administrator Cheri Oz. 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. 2026-06523 Filed 4-2-26; 8:45 am] BILLING CODE 4410-09-P

Footnotes

(1) 21 U.S.C. 802(34).

(2) Id.

(3) Designation of P2P Methyl Glycidic Acid as a List I Chemical, 90 FR 47670 (Oct. 2, 2025).

(4) Id. at 47671-72.

(5) See id. at 47670.

(6) Designation of P2P Methyl Glycidic Acid as a List I Chemical, 90 FR at 47670.

(7) 21 CFR 1310.02(c), (h); 5 U.S.C. 553(c).

(8) Designation of P2P Methyl Glycidic Acid as a List I Chemical, 90 FR at 47675.

(9) Id.

(10) 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”).

(11) 21 CFR 1309.21.

(12) 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).

(13) 21 U.S.C. 822(c)(2), 957(b)(1)(B).

(14) See 21 CFR 1309.23(b)(1).

(15) 21 CFR 1310.05(d).

(16) 21 U.S.C. 830(b); 21 CFR 1310.05(a), (b).

(17) 21 U.S.C. 880.

(18) 5 U.S.C. 601-612.

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