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, 24703-24708 [2021-09697]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Rules and Regulations]
[Pages 24703-24708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09697]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[Docket No. DEA-542]


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

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration is finalizing a December 
21, 2020, notice of proposed rulemaking to designate three chemicals, 
known as PMK glycidate, PMK glycidic acid, and APAA, as list I 
chemicals under the Controlled Substances Act (CSA). PMK glycidate and 
PMK glycidic acid are used in and are important to the manufacture of 
the schedule I controlled substance 3,4-methylenedioxymethamphetamine 
(MDMA) and other ``ecstasy''-type substances, and APAA is used in and 
is important to the manufacture of the schedule II controlled 
substances amphetamine and methamphetamine. This final rulemaking 
subjects handlers (manufacturers, distributors, importers, and 
exporters) of PMK glycidate, PMK glycidic acid, and APAA to the 
chemical regulatory provisions of the CSA and its implementing 
regulations.

DATES: Effective June 9, 2021.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone: (571) 362-3249.

[[Page 24704]]


SUPPLEMENTARY INFORMATION: This final rule designates the following 
chemicals as list I chemicals and subjects them to the regulatory 
requirements applicable to list I chemicals:
     3,4-MDP-2-P methyl glycidate (PMK glycidate), including 
its optical and geometric isomers;
     3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), 
including its salts, optical and geometric isomers, and salts of 
isomers; and
     alpha-phenylacetoacetamide (APAA), including its optical 
isomers,.

Legal Authority

    The Controlled Substances Act (CSA) and the Drug Enforcement 
Administration's (DEA) implementing regulations give the Attorney 
General, as delegated to the Administrator of DEA, the authority to 
specify, by regulation, a chemical as a ``list I chemical.'' \1\ This 
term refers to a chemical that is used in manufacturing a controlled 
substance in violation of subchapter I (Control and Enforcement) of the 
CSA and is important to the manufacture of the controlled substance.\2\ 
The current list of all list I chemicals is available in 21 CFR 
1310.02(a).
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    \1\ 21 U.S.C. 802(34) and 871(b) and 21 CFR 1310.02(c).
    \2\ 21 U.S.C. 802(34) and 21 CFR 1300.02(b).
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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), December 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 (tables annexed to such Convention), the United States must 
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

    In a letter dated May 23, 2019, the Secretary-General of the United 
Nations, in accordance with Article 12, paragraph 6 of the 1988 
Convention, informed the United States Secretary of State that the 
Commission on Narcotic Drugs (CND) voted to place the chemicals 3,4-
MDP-2-P methyl glycidate (PMK glycidate) (and all stereoisomers), 3,4-
MDP-2-P methyl glycidic acid (PMK glycidic acid) (and all 
stereoisomers), and alpha-phenylacetoacetamide (APAA) (and all optical 
isomers) in Table I of the 1988 Convention (CND Decisions 62/10, 62/11, 
and 62/12, respectively) at its 62nd Session on March 19, 2019.
    On December 21, 2020, DEA published a notice of proposed rulemaking 
(NPRM) [85 FR 82984] to designate 3,4-MDP-2-P methyl glycidate (PMK 
glycidate), including its optical and geometric isomers; 3,4-MDP-2-P 
methyl glycidic acid (PMK glycidic acid), including its salts, optical 
and geometric isomers, and salts of isomers; and alpha-
phenylacetoacetamide (APAA), including its optical isomers, as list I 
chemicals under the CSA.\3\
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    \3\ DEA proposed to control the same set of chemicals specified 
by the CND. However, DEA used more precise terms that relate to the 
specific chemical and variations that can actually exist.
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    PMK glycidate, PMK glycidic acid, and APAA are close chemical 
relatives of controlled list I precursor 3,4 methylenedioxyphenyl-2-
propanone (3,4-MDP-2-P), and have been made specifically to circumvent 
existing precursor controls. DEA has not identified any known 
legitimate uses for these chemicals, other than possible research 
purposes. The first two substances, PMK glycidate and PMK glycidic 
acid, are closely related in chemical structure to precursors of 3,4-
methylenedioxymethamphetamine (MDMA) (schedule I) and other 
``ecstasy''-type substances in schedule I. APAA is a precursor of 
schedule II controlled substances amphetamine and methamphetamine.
    All three chemicals are used for the illicit manufacture of two 
precursors listed in Table I of the 1988 Convention (3,4-MDP-2-P and 1-
phenyl-2-propanone (P-2-P)). For years, countries have reported to the 
International Narcotics Control Board (INCB) the illicit trafficking 
and use of these chemicals in manufacturing controlled substances, with 
increasing frequency and amounts reported in 2018 and 2019.\4\
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    \4\ Precursors and Chemicals Frequently Used in the Illicit 
Manufacture of Narcotic Drugs and Psychotropic Substances: Report of 
the International Narcotics Control Board for 2018 on the 
Implementation of Article 12 of the United Nations Convention 
against Illicit Traffic in Narcotic Drugs and Psychotropic 
Substances of 1988 (E/INCB/2018/4, Released March 5, 2019) and 
Report of the International Narcotics Control Board for 2019 on the 
Implementation of Article 12 of the United Nations Convention 
against Illicit Traffic in Narcotic Drugs and Psychotropic 
Substances of 1988 (E/INCB/2019/1, Released February 27. 2020)
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Comments Received and Designation of PMK Glycidate, PMK Glycidic Acid, 
and APAA as List I Chemicals

    In response to the December 21, 2020, NPRM, DEA received one 
anonymous comment expressing general opposition to the ``war on drugs'' 
and to the addition of more substances to the list and under CSA 
control. DEA considers the general comment about the war on drugs to be 
outside the scope of this rulemaking.
    Regarding the general opposition to listing more substances, DEA 
notes that it proposed to designate and add these three specific 
chemicals to the list as they met the statutory and regulatory 
definition of a list I chemical, and DEA is using its legal authority 
to so designate these chemicals as list I chemicals.
    Therefore, for the reasons discussed in the NPRM, and reiterated in 
the above background section, the Acting Administrator of DEA finds 
that PMK glycidate, PMK glycidic acid, and APAA are used in the 
manufacture of controlled substances in violation of the CSA, and are 
important to the manufacture of these controlled substances. Therefore, 
the Acting Administrator designates PMK glycidate, PMK glycidic acid, 
and APAA as list I chemicals.

Chemical Mixtures of PMK Glycidate, PMK Glycidic Acid or APAA

    Pursuant to this final rulemaking, chemical mixtures containing any 
of these three chemicals are subject to regulatory requirements at any 
concentration unless a manufacturer submits to DEA an application for 
exemption of a 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; application). Since even a 
small amount of these three chemicals can potentially yield a 
significant amount of controlled substances, DEA believes that 
regulation of chemical mixtures containing any amount of these three 
chemicals is necessary to prevent their illicit extraction, isolation, 
and use. This rule modifies the ``Table of Concentration Limits'' in 21 
CFR 1310.12(c) to reflect the fact that chemical mixtures containing 
any amount of these three chemicals are subject to CSA chemical control 
provisions, including 21 CFR parts 1309, 1310, 1313, and 1316.

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.\5\ Manufacturers may submit an

[[Page 24705]]

application for exemption for those mixtures that do not meet the 
category criteria set forth in 21 CFR 1310.12(d) for an automatic 
exemption. DEA may grant an exemption of a chemical mixture if the 
Administrator determines that the mixture is formulated in such a way 
that it cannot be easily used in the illicit production of a controlled 
substance, and the listed chemical or chemicals contained in the 
chemical mixture cannot be readily recovered (i.e., the chemical 
mixture meets the conditions set forth in 21 U.S.C. 802(39)(A)(vi) and 
21 CFR 1310.13(a)(1)-(2)).
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    \5\ 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 not a list I or list II chemical, and the 
mixture and its listed chemical(s) must meet certain other 
conditions.
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Requirements for Handling List I Chemicals

    The designation of these three chemicals as list I chemicals 
subjects handlers (manufacturers, distributors, importers, and 
exporters) and proposed handlers to all of the regulatory controls and 
administrative, civil, and criminal actions applicable to the 
manufacture, distribution, importation, and exportation of a list I 
chemical. Upon the effective date of this final rulemaking, persons 
potentially handling these three chemicals, including regulated 
chemical mixtures containing any of these three chemicals, 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 any of 
these three chemicals 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 any of these three chemicals.\6\ 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.\7\
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    \6\ 21 CFR 1309.21.
    \7\ 21 CFR 1309.23(a). See also 21 U.S.C. 822(e)(1) with 
separate registration requirements pertaining to manufacturing or 
distributing a list I chemical.
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    DEA notes that under the CSA, a ``warehouseman'' is not required to 
register and may lawfully possess a list I chemical, if the possession 
of the chemical is in the usual course of business or employment.\8\ 
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.\9\ 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.
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    \8\ 21 U.S.C. 822(c)(2) and 21 U.S.C. 957(b)(1)(B).
    \9\ See 21 CFR 1309.23(b)(1).
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    Upon the effective date of this final rulemaking, any person 
manufacturing, distributing, importing, or exporting any of these three 
chemicals will become subject to the registration requirement under the 
CSA. DEA recognizes, however, that it is not possible for persons 
subject to the registration requirement to immediately complete and 
submit an application for registration and for DEA to immediately issue 
registrations for those activities. Therefore, to allow continued 
legitimate commerce in these three chemicals, DEA is establishing in 21 
CFR 1310.09 a temporary exemption from the registration requirement for 
persons desiring to engage in activities with any of these three 
chemicals, provided that DEA receives a properly completed application 
for registration or application for exemption of chemical mixtures on 
or before June 9, 2021. The temporary exemption for such persons will 
remain in effect until DEA takes final action on their application for 
registration or application for exemption of a chemical mixture.
    The temporary exemption applies solely to the registration 
requirement; all other chemical control requirements, including 
recordkeeping and reporting, will become effective on the effective 
date of the final rule. Therefore, all transactions of these three 
chemicals and chemical mixtures containing any of these three chemicals 
will be regulated while an application for registration or exemption is 
pending. This is necessary because failing to regulate these 
transactions could result in increased diversion of chemicals desirable 
to drug traffickers.
    Additionally, the temporary exemption does not suspend applicable 
federal criminal laws relating to these three chemicals, nor does it 
supersede State or local laws or regulations. All handlers of any of 
these three chemicals must comply with applicable State and local 
requirements in addition to the CSA regulatory controls.
    2. Records and Reports. Every DEA registrant must maintain records 
and submit reports to DEA with respect to these three chemicals 
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), 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 must submit 
to DEA manufacturing, inventory, and use data on an annual basis.\10\ 
Existing standard industry reports containing the required information 
are acceptable, provided the information is separate or readily 
retrievable from the report.
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    \10\ 21 CFR 1310.05(d). See also 21 U.S.C. 830(b)(2).
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    The CSA and its implementing regulations require that each 
regulated person must report to DEA any regulated transaction involving 
an extraordinary quantity of a listed chemical, an uncommon method of 
payment or delivery, or any other circumstance that the regulated 
person believes may indicate that the listed chemical will be used in 
violation of subchapter I of the CSA or 21 CFR part 1310. 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.\11\
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    \11\ 21 U.S.C. 830(b)(1)(A)-(C) and 21 CFR 1310.05(a) and 
(b)(1).
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    3. Importation and Exportation. All importation and exportation of 
these three chemicals must be done in compliance with 21 U.S.C. 957, 
958, and 971 and in accordance with 21 CFR part 1313.
    4. Security. All applicants and registrants must provide effective 
controls against theft and diversion in accordance with 21 CFR 1309.71-
1309.73.
    5. Administrative Inspection. Places, including factories, 
warehouses, or other establishments and conveyances, where registrants 
or other regulated persons may lawfully hold, manufacture, distribute, 
or otherwise dispose of a list I chemical or where records relating to 
those activities are maintained, are controlled premises as defined in 
21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for 
administrative inspections of these controlled premises as provided in 
21 CFR part 1316, subpart A. 21 U.S.C. 880(b).

[[Page 24706]]

    6. Liability. Any activity involving these three chemicals not 
authorized by, or in violation of, the CSA is unlawful, and may subject 
the person to administrative, civil, and/or criminal action.

Regulatory Analyses

Executive Orders 12866 and 13563, Regulatory Planning and Review and 
Improving Regulation and Regulatory Review

    This rule was developed in accordance with the principles of 
Executive Orders (E.O.) 12866 and 13563. 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.
    E.O. 12866 classifies a ``significant regulatory action,'' 
requiring review by the Office of Management and Budget (OMB), as any 
regulatory action that is likely to result in a rule that may: (1) Have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the E.O. DEA has determined 
that this rule is not a ``significant regulatory action'' under E.O. 
12866, section 3(f).
    As finalized, PMK glycidate, PMK glycidic acid, and APAA are 
subject to all of the regulatory controls and administrative, civil, 
and criminal sanctions applicable to the manufacture, distribution, 
importing, and exporting of list I chemicals. The first two chemicals, 
PMK glycidate and PMK glycidic acid, are closely related in chemical 
structure to precursors of MDMA and other ``ecstasy''-type substances, 
as discussed in the above background section. APAA is a precursor of 
amphetamine and methamphetamine. All three chemicals are highly 
suitable for the illicit manufacture of precursors listed in Table I of 
the 1988 Convention (3,4-methylenedioxyphenyl-2-propanone (3,4-MDP-2-P) 
and 1-phenyl-2-propanone (P-2-P)). As noted earlier, incidents of 
illicit manufacture and tracking of these three chemicals have been 
reported for many years to the INCB, with an increase in the frequency 
and amounts reported in 2018 and 2019.
    In making its assessment pursuant to Article 12, paragraph 4 of the 
1988 Convention, the CND found that there was no known legitimate 
manufacture of and trade in any of the three chemicals and that their 
use was limited, in small amounts, to research, development, 
laboratory, and analytical purposes. DEA also searched information in 
the public domain for legitimate uses of these three chemicals, and 
likewise, did not identify any known legitimate use for any of these 
chemicals, other than possibly for research purposes. DEA evaluated the 
costs and benefits of this action.
    DEA cannot rule out the possibility that minimal quantities of PMK 
glycidate, PMK glycidic, or APAA are used for the manufacturing of 
legitimate pharmaceutical substances. However, DEA did not receive any 
public comments to that effect in response to the NPRM.
Costs
    As stated above, the only use for PMK glycidate and PMK glycidic 
acid is as intermediaries for the manufacturing of MDMA and other 
``ecstasy''-type substances. Similarly, the only use for APAA is as a 
precursor for amphetamine and methamphetamine. Any manufacturer, 
distributor, importer, or exporter of any of these three chemicals for 
legitimate pharmaceutical commerce, if they exist at all, will incur 
costs if they are not already registered for handling List I chemicals. 
The primary costs associated with this rule are the annual registration 
fees ($3,047 for manufacturers and $1,523 for distributors, importers, 
and exporters). Moreover, any manufacturer that uses any of these three 
chemicals for legitimate pharmaceutical purposes is likely to already 
be registered with DEA and have all security and other handling 
processes in place, resulting in minimal cost.
    DEA has identified ten domestic suppliers of one or more of these 
chemicals, PMK glycidate, PMK glycidic acid, and APAA; nine of these 
suppliers are not currently registered with DEA to handle list I 
chemicals. The amount of these three chemicals distributed by these 
suppliers is unknown. It is common for chemical distributors to have 
items on their catalog while not actually having any material level of 
sales. Based on the discussion above, DEA believes any quantity of 
sales from these distributors for legitimate pharmaceutical purposes is 
minimal. As finalized, suppliers for the legitimate use of PMK 
glycidate, PMK glycidic acid, and APAA are expected to choose the 
least-cost option, which in many cases may lead them to stop selling 
the minimal quantities, if any, of PMK glycidate, PMK glycidic acid, 
and APAA, rather than incur the registration cost. Therefore, DEA 
estimates that the cost of foregone sales is minimal; and thus, the 
cost of this rule is minimal.
    This analysis excludes consideration of any economic impact to 
those businesses that facilitate the manufacturing and distribution of 
PMK glycidate, PMK glycidic acid, or APAA for the illicit production of 
amphetamine, methamphetamine, MDMA, or other ``ecstasy''-type 
substances.
Benefits
    Controlling PMK glycidate, PMK glycidic acid, and APAA is expected 
to prevent, curtail, and limit the unlawful manufacture and 
distribution of amphetamine, methamphetamine, and MDMA and other 
``ecstasy''-type substances. This action is also expected to assist in 
the prevention of possible theft or diversion of PMK glycidate, PMK 
glycidic acid, and APAA from any legitimate firms. DEA also believes 
control is necessary to prevent unscrupulous chemists from synthesizing 
PMK glycidate, PMK glycidic acid, and APAA and selling them (as an 
unregulated material) through the internet and other channels to 
individuals who may wish to acquire unregulated intermediary chemicals 
for the purpose of manufacturing illicit amphetamine, methamphetamine, 
or MDMA or other ``ecstasy''-type substances.
    In summary, DEA conducted a qualitative analysis of costs and 
benefits. DEA believes this action will minimize the diversion of PMK 
glycidate, PMK glycidic acid, and APAA. DEA believes the legitimate 
market for PMK glycidate, PMK glycidic acid, and APAA for legitimate 
pharmaceutical purposes is minimal. Thus, any potential cost resulting 
from this regulation is minimal.

Executive Order 12988, Civil Justice Reform

    This 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

[[Page 24707]]

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 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 (RFA)

    The Acting Administrator, in accordance with the RFA,\12\ 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.
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    \12\ 5 U.S.C. 601-612.
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    As discussed above, PMK glycidate, PMK glycidic acid, and APAA will 
now become 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. PMK glycidate and PMK glycidic acid are closely related in 
chemical structure to precursors of MDMA and other ``ecstasy''-type 
substances. APAA is a precursor of amphetamine and methamphetamine. All 
three chemicals are highly suitable for the illicit manufacture of 
precursors listed in Table I of the 1988 Convention (3,4-
methylenedioxyphenyl-2-propanone (3,4-MDP-2-P) and 1-phenyl-2-propanone 
(P-2-P)). DEA has not identified any legitimate industrial use for PMK 
glycidate, PMK glycidic acid, or APAA, other than as intermediary 
chemicals in the production of amphetamine, methamphetamine, and MDMA 
or other ``ecstasy''-type substances. Therefore, DEA believes the vast 
majority, if not all, of PMK glycidate, PMK glycidic acid, and APAA is 
used for the illicit manufacturing of amphetamine, methamphetamine, and 
MDMA or other ``ecstasy''-type substances. The primary costs associated 
with this rule are the annual registration fees ($3,047 for 
manufacturers and $1,523 for distributors, importers, and exporters), 
but only if they are not already registered to handle any list I 
chemicals.
    DEA has identified ten domestic suppliers of one or more of the 
chemicals, PMK glycidate, PMK glycidic acid, and APAA; nine of these 
suppliers are currently not registered with DEA to handle list I 
chemicals. All nine non-registered domestic suppliers are affected, and 
all nine (94.5 percent, based on Small Business Administration size 
standard for chemical distributors and Statistics of U.S. Businesses 
data) are estimated to be small entities. The quantity of these three 
chemicals distributed by these suppliers is unknown. It is common for 
chemical distributors to have items on their catalog while not actually 
having any material level of sales. Based on the discussion above, DEA 
believes any quantity of sales from these distributors for legitimate 
pharmaceutical purposes is minimal. DEA did not receive any comments to 
the contrary in response to the NPRM. DEA estimates that this rule will 
not have a significant economic impact on a substantial number of small 
entities.

Unfunded Mandates Reform Act of 1995 (UMRA)

    In accordance with the UMRA, 2 U.S.C. 1501 et seq., DEA has 
determined and certifies that this rule will 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 
million or more (adjusted annually for inflation) in any 1 year. . . 
.'' Therefore, neither a Small Government Agency Plan nor any other 
action is required under the UMRA.

Paperwork Reduction Act

    The action does not impose a new collection of information 
requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. 
This action will not impose recordkeeping or reporting requirements on 
State or local governments, individuals, businesses, or organizations. 
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.

Congressional Review Act

    This final rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is 
submitting a copy of this final rule to both Houses of Congress and to 
the Comptroller General.

List of Subjects 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

0
1. The authority citation for part 1310 continues to read as follows:

    Authority:  21 U.S.C. 802, 827(h), 830, 871(b), 890.

0
2. In Sec.  1310.02, add paragraphs (a)(34) through (36) to read as 
follows:


Sec.  1310.02  Substances covered.

* * * * *
    (a) * * *
    (34) 3,4-MDP-2-P methyl glycidate (PMK glycidate) and its optical 
and geometric isomers 8535
    (35) 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its 
salts, optical and geometric isomers, and salts of isomers 8525
    (36) Alpha-phenylacetoacetamide (APAA) and its optical isomers 8515
* * * * *

0
3. In Sec.  1310.04:
0
a. Redesignate paragraphs (g)(1)(vii) through (xiii) as paragraphs 
(g)(1)(x) through (xvi), respectively;
0
b. Redesignate paragraphs (g)(1)(i) through (vi) as paragraphs 
(g)(1)(ii) through (vii), respectively; and
0
c. Add new paragraphs (g)(1)(i), (viii), and (ix).
    The additions read as follows:


Sec.  1310.04  Maintenance of records.

* * * * *
    (g) * * *
    (1) * * *
    (i) Alpha-phenylacetoacetamide (APAA) and its optical isomers
* * * * *
    (viii) 3,4-MDP-2-P methyl glycidate (PMK glycidate) and its optical 
and geometric isomers
    (ix) 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its 
salts, optical and geometric isomers, and salts of isomers
* * * * *

0
4. In Sec.  1310.09, add paragraph (q) to read as follows:

[[Page 24708]]

Sec.  1310.09  Temporary exemption from registration.

* * * * *
    (q)(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 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P 
methyl glycidic acid (PMK glycidic acid), and alpha-
phenylacetoacetamide (APAA), including regulated chemical mixtures 
pursuant to Sec.  1310.12, is temporarily exempted from the 
registration requirement, provided that DEA receives a properly 
completed application for registration or application for exemption for 
a chemical mixture containing regulated forms of 3,4-MDP-2-P methyl 
glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK 
glycidic acid), or alpha-phenylacetoacetamide (APAA) pursuant to Sec.  
1310.13 on or before (30 days after publication of a rule implementing 
regulations regarding these three chemicals). The exemption will 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 3,4-MDP-2-P methyl 
glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK 
glycidic acid), or alpha-phenylacetoacetamide (APAA) whose application 
for exemption is subsequently denied by DEA must obtain a registration 
with DEA. A temporary exemption from the registration requirement will 
also be provided for those persons whose applications for exemption are 
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 will remain in effect until DEA 
takes final action on their registration application.

0
5. In Sec.  1310.12, in paragraph (c), add in alphanumerical order 
entries for 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P 
methyl glycidic acid (PMK glycidic acid), and alpha-
phenylacetoacetamide (APAA) in the table ``Table of Concentration 
Limits'' to read as follows:


Sec.  1310.12  Exempt chemical mixtures.

* * * * *
    (c) * * *

                                          Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
                                               DEA
                                            chemical           Concentration              Special conditions
                                            code no.
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
3,4-MDP-2-P methyl glycidate (PMK                8535  Not exempt at any             Chemical mixtures
 glycidate) and its optical and geometric               concentration.                containing any amount of
 isomers.                                                                             this chemical are not
                                                                                      exempt.
3,4-MDP-2-P methyl glycidic acid (PMK            8525  Not exempt at any             Chemical mixtures
 glycidic acid) and its salts, optical                  concentration.                containing any amount of
 and geometric isomers, and salts of                                                  this chemical are not
 isomers.                                                                             exempt.
Alpha-phenylacetoacetamide (APAA) and its        8515  Not exempt at any             Chemical mixtures
 optical isomers.                                       concentration.                containing any amount of
                                                                                      this chemical are not
                                                                                      exempt.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-09697 Filed 5-7-21; 8:45 am]
BILLING CODE 4410-09-P