[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Rules and Regulations]
[Pages 64362-64366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24952]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[Docket No. DEA-678]


Designation of Methyl alpha-phenylacetoacetate, a Precursor 
Chemical Used in the Illicit Manufacture of Phenylacetone, 
Methamphetamine, and Amphetamine, as a List I Chemical

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rulemaking.

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SUMMARY: The Drug Enforcement Administration is finalizing, without 
change, a March 30, 2021, notice of proposed rulemaking to designate 
the chemical methyl alpha-phenylacetoacetate (also known as MAPA; 
methyl 3-oxo-2-phenylbutanoate; methyl 2-phenylacetoacetate; [alpha]-
acetyl-benzeneacetic acid, methyl ester; and CAS Number: 16648-44-5) 
and its optical isomers as a list I chemical under the Controlled 
Substances Act (CSA). Methyl alpha-phenylacetoacetate is used in 
clandestine laboratories to illicitly manufacture the schedule II 
controlled substances phenylacetone (also known as phenyl-2-propanone, 
P2P, or benzyl methyl ketone), methamphetamine, and amphetamine and is 
important to the manufacture of these controlled substances. This final 
rulemaking subjects handlers (manufacturers, distributors, importers, 
and exporters) of MAPA to the chemical regulatory provisions of the CSA 
and its implementing regulations.

DATES: Effective December 20, 2021.

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 methyl alpha-
phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate) and its 
optical isomers as a list I chemical. This action subjects handlers of 
MAPA 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 
MAPA. As such, all MAPA transactions are regulated, regardless of 
transaction size, and are subject to control under the CSA. In 
addition, chemical mixtures containing MAPA are not exempt from 
regulatory requirements at any concentration. Therefore, all 
transactions of chemical mixtures containing any quantity of MAPA are 
regulated pursuant to the CSA.

Legal Authority

    The CSA and the Drug Enforcement Administration's (DEA) 
implementing regulations give the Attorney General, as delegated to the 
Administrator of DEA (Administrator), 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 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

    In a letter dated May 7, 2020, 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 chemical methyl 
alpha-phenylacetoacetate (MAPA), including its optical isomers, in 
Table I of the 1988 Convention (CND Decision 63/1) at its 63rd Session 
on March 4, 2020.
    On March 30, 2021, DEA published a notice of proposed rulemaking 
(NPRM) [86 FR 16558] to designate methyl alpha-phenylacetoacetate 
(MAPA; methyl 3-oxo-2-phenylbutanoate) and its optical isomers as a 
list I chemical under the CSA. In the NPRM, the Acting Administrator 
found that MAPA 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. 
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.
    MAPA is a close chemical relative of precursors controlled under 
the CSA and the 1988 Convention (e.g., alpha-phenylacetoacetonitrile 
(APAAN) and alpha-phenylacetoacetamide (APAA)) and the timing of its 
emergence suggests it is trafficked to circumvent these precursor 
controls, particularly the more recent control on APAA.\3\ DEA has not 
identified any known legitimate use for MAPA, other than in small 
amounts for research, development, and laboratory analytical purposes. 
The International Narcotics Control Board (INCB) notes that MAPA does 
not have any legitimate use,\4\ and despite this, the INCB highlighted 
an increase in the frequency of seizures and amounts seized reported 
through Precursors Incident Communication System (PICS) since November 
2018.\5\ This trend continued

[[Page 64363]]

into 2020, with 37 incidents involving MAPA reported through PICS in 
the first 10 months of the year, totaling almost 21.5 metric tons.\6\
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    \3\ The CND added APAAN and APAA to Table I of the 1988 
Convention in March 2014 and March 2019, respectively. DEA 
designated APAAN and APAA as list I chemicals on July 14, 2017 
(effective date: August 14, 2017) [82 FR 32457], and May 10, 2021 
(effective date: June 9, 2021) [86 FR 24703], respectively, with a 
correction notice for APAA on June 7, 2021 [86 FR 30169].
    \4\ Statement by Mr. Cornelis de Joncheere, President, 
International Narcotics Control Board, Reconvened sixty-second 
session of the Commission on Narcotic Drugs, 13 December 2019, at 1.
    \5\ The Precursors Incident Communication System or 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.
    \6\ INCB Report on Precursors for 2020, 25 March 2021, at 17.
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    As noted in the NPRM, by DEA's designating MAPA as a list I 
chemical, the United States will fulfill its obligations under Article 
12 of the 1988 Convention. The NPRM requested public comments on the 
proposed designation; however, DEA did not receive any comments.

Designation of MAPA and Its Optical Isomers as a List I Chemical

    For the reasons discussed in the NPRM and reiterated in the above 
background section, the Administrator finds that MAPA 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 MAPA and its optical isomers as a list I 
chemical.

Chemical Mixtures of MAPA

    Pursuant to this final rulemaking, chemical mixtures containing 
MAPA 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 by application). Since even a small 
amount of MAPA can potentially yield a significant amount of controlled 
substances, DEA believes that regulation of chemical mixtures 
containing any amount of MAPA is necessary to prevent its illicit 
extraction, isolation, and use. This rule modifies the ``Table of 
Concentration Limits'' in 21 CFR 1310.12(c) to reflect the fact that a 
chemical mixture containing any amount of MAPA is 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.\7\ Manufacturers may submit an application for exemption 
for those mixtures that do not meet the criteria set forth in 21 CFR 
1310.12(d) for an automatic exemption. 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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    \7\ 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.
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Requirements for Handling List I Chemicals

    The designation of MAPA 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 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 MAPA, 
including regulated chemical mixtures containing MAPA, 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, MAPA 
or a chemical mixture containing MAPA 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 MAPA.\8\ 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.\9\
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    \8\ 21 CFR 1309.21.
    \9\ 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, ``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.\10\ 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.\11\ 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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    \10\ 21 U.S.C. 822(c)(2) and 21 U.S.C. 957(b)(1)(B).
    \11\ 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 MAPA or a chemical 
mixture containing MAPA 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 MAPA, DEA is 
establishing in 21 CFR 1310.09 a temporary exemption from the 
registration requirement for persons desiring to engage in activities 
with MAPA, provided that DEA receives a properly completed application 
for registration or application for exemption of chemical mixtures on 
or before December 20, 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 MAPA and 
chemical mixtures containing MAPA 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 a chemical desirable to drug traffickers.
    Additionally, the temporary exemption for registration does not 
suspend applicable Federal criminal laws relating to MAPA, nor does it 
supersede State or local laws or regulations. All handlers of MAPA 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 MAPA 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 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

[[Page 64364]]

manufacturing, inventory, and use data on an annual basis.\12\ 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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    \12\ 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. 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.\13\
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    \13\ 21 U.S.C. 830(b) and 21 CFR 1310.05(a) and (b).
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    3. Importation and Exportation. All importation and exportation of 
MAPA 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.\14\
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    \14\ 21 U.S.C. 880.
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    6. Liability. Any activity involving MAPA not authorized by, or in 
violation of, the CSA is unlawful, and may subject the person to 
administrative, civil, and/or criminal action.

Finalization of Proposed Rule

    DEA did not receive any comments on the NPRM proposing to designate 
the chemical methyl alpha-phenylacetoacetate (also known as MAPA; 
methyl 3-oxo-2-phenylbutanoate; methyl 2-phenylacetoacetate; [alpha]-
acetyl-benzeneacetic acid, methyl ester; and CAS Number: 16648-44-5) 
and its optical isomers as a list I chemical under the CSA. For the 
reasons discussed in this rulemaking, DEA is finalizing the NPRM 
without any change.

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.
    Section 3(f) of E.O. 12866 classifies a ``significant regulatory 
action,'' requiring review by the Office of Management and Budget 
(OMB), as any regulatory action that is likely to result in a rule that 
may: (1) Have an annual effect on the economy of $100 million or more 
or adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal 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. As set 
forth below in the ``Costs'' discussion, this final rule will not have 
the economic effects described in E.O. 12866, section 3(f)(1). Since 
this rule merely designates MAPA and its optical isomers as a list I 
chemical, DEA believes that this rule does not create or cause the 
other effects described in section 3(f)(2)-(4). OMB has determined that 
this rule is not a ``significant regulatory action'' under E.O. 12866, 
section 3(f).
    As finalized, MAPA is 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.
    MAPA is a close chemical relative of precursors controlled under 
the 1988 Convention (e.g., APAAN and APAA), as discussed in the above 
background section. MAPA is a precursor of methamphetamine and 
amphetamine, and it is highly suitable for the illicit manufacture of 
P2P, a precursor listed in Table I of the 1988 Convention. As noted 
earlier, incidents of illicit manufacture and trafficking of MAPA have 
been reported to the INCB with an increase in the frequency of seizures 
and amounts seized since November 2018.
    DEA has searched information in the public domain for any 
legitimate uses of MAPA. Other than the small amounts for research, 
development, and laboratory analytical purposes, DEA has not documented 
any industrial use for MAPA except for it being a chemical intermediate 
in the production of the schedule II substances P2P, methamphetamine, 
and amphetamine. Legal conversion of MAPA 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, MAPA is used 
for the manufacturing of illicit P2P, methamphetamine, and amphetamine.
    DEA cannot rule out the possibility that minimal quantities of MAPA 
are used for the manufacturing of legitimate P2P. However, DEA did not 
receive any public comments to that effect in response to the NPRM.
    DEA evaluated the costs and benefits of this action.

Costs

    As stated above, the only use for MAPA 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 MAPA for the production of legitimate P2P, methamphetamine, and 
amphetamine, 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 for 
manufacturers ($3,699) and for distributors, importers, and exporters 
($1,850). Moreover, any manufacturer that uses MAPA 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.

[[Page 64365]]

    DEA has identified five domestic suppliers of MAPA, only one of 
which is registered with DEA to handle list I chemicals. The amount of 
MAPA 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 MAPA are expected to choose the least-cost option, 
which in many cases may lead them to stop selling the minimal 
quantities, if any, of MAPA, 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 
MAPA for the illicit production of P2P, methamphetamine, and 
amphetamine.

Benefits

    Controlling MAPA is expected to prevent, curtail, and limit the 
unlawful manufacture and distribution of the controlled substances P2P, 
methamphetamine, and amphetamine. This action is also expected to 
assist in preventing the possible theft or diversion of MAPA from any 
legitimate firms. DEA also believes control is necessary to prevent 
unscrupulous chemists from synthesizing MAPA and selling it (as an 
unregulated material) through the internet and other channels, to 
individuals who may wish to acquire an unregulated chemical 
intermediate 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 MAPA. 
DEA believes the legitimate market for MAPA for the legitimate 
manufacturing of P2P, methamphetamine, and amphetamine 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 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 Administrator, in accordance with the RFA,\15\ 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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    \15\ 5 U.S.C. 601-612.
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    As discussed above, MAPA 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. MAPA 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 MAPA, other than its role as a chemical intermediate 
in the production of P2P, methamphetamine, and amphetamine. Legal 
conversion of MAPA to P2P 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 MAPA is used for the illicit 
manufacturing of P2P, methamphetamine, and amphetamine. The primary 
costs associated with this rule are the annual registration fees 
($3,699 for manufacturers and $1,850 for distributors, importers, and 
exporters), but only if they are not already registered to handle any 
list I chemicals.
    DEA has identified five domestic suppliers of MAPA, only one of 
which is registered with DEA to handle list I chemicals. Based on Small 
Business Administration (SBA) size standards for chemical distributors 
and Statistics of U.S. Business data, each of the five suppliers are 
small entities because their revenues are below SBA's $150 million 
threshold. The quantity of MAPA 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. Legal 
conversion of MAPA to P2P in the United States is limited to small, 
gram quantities. DEA believes any quantity of sales of MAPA from these 
distributors for legitimate P2P manufacturing 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 
$100,000,000 or more (adjusted annually for inflation) in any 1 year * 
* *.'' Therefore, neither a Small Government Agency Plan nor any other 
action is required under 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:

[[Page 64366]]

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)(37) to read as follows:


Sec.  1310.02  Substances covered.

* * * * *
    (a) * * *

(37) methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-         8795
 phenylbutanoate) and its optical isomers.......................
 

* * * * *


0
3. In Sec.  1310.04:
0
a. Redesignate paragraphs (g)(1)(x) through (xvi) as paragraphs 
(g)(1)(xi) through (xvii), respectively; and
0
b. Add new paragraph (g)(1)(x).
    The addition reads as follows:


Sec.  1310.04  Maintenance of records.

* * * * *
    (g) * * *
    (1) * * *
    (x) methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-
phenylbutanoate) and its optical isomers
* * * * *


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


Sec.  1310.09  Temporary exemption from registration.

* * * * *
    (r)(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 methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-
phenylbutanoate) and its optical isomers, 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 MAPA pursuant to Sec.  
1310.13 on or before December 20, 2021. 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 methyl alpha-
phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate) and its 
optical isomers 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, in the Table of Concentration Limits under List I 
Chemicals in paragraph (c), add an entry for ``methyl alpha-
phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate)'' 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
----------------------------------------------------------------------------------------------------------------
                                                List I Chemicals
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
methyl alpha-phenylacetoacetate (MAPA;              8795  Not exempt at any           Chemical mixtures
 methyl 3-oxo-2-phenylbutanoate) and its                   concentration.              containing any amount of
 optical isomers.                                                                      MAPA and its optical
                                                                                       isomers are not exempt.
 
                                                  * * * * * * *
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* * * * *

Anne Milgram,
Administrator.
[FR Doc. 2021-24952 Filed 11-17-21; 8:45 am]
BILLING CODE 4410-09-P