Designation of Methyl alpha-phenylacetoacetate, a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical, 16558-16565 [2021-05346]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 86, Number 59 (Tuesday, March 30, 2021)]
[Proposed Rules]
[Pages 16558-16565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05346]


-----------------------------------------------------------------------

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: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration is proposing the control 
of 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 
or P2P), methamphetamine, and amphetamine and is important to the 
manufacture of these controlled substances. If finalized, this action 
would subject handlers of methyl alpha-phenylacetoacetate to the 
chemical regulatory provisions of the CSA and its implementing 
regulations. This rulemaking does not establish a threshold for 
domestic and international transactions of methyl alpha-
phenylacetoacetate. As such, all transactions of chemical mixtures 
containing methyl alpha-phenylacetoacetate would be regulated at any 
concentration and would be subject to control under the CSA.

DATES: Comments must be submitted electronically or postmarked on or 
before June 1, 2021. Commenters should be aware that the electronic 
Federal Docket Management System will not accept any comments after 
11:59 p.m. Eastern Time on the last day of the comment period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-678'' on all electronic and written correspondence, 
including any attachments.
     Electronic comments: The Drug Enforcement Administration 
(DEA) encourages that all comments be submitted electronically through 
the Federal eRulemaking Portal which provides the ability to type short 
comments directly into the comment field on the web page or attach a 
file for lengthier comments. Please go to https://www.regulations.gov 
and follow the online instructions at that site for submitting 
comments. Upon completion of your submission, you will receive a 
Comment Tracking Number for your comment. Please be aware that 
submitted comments are not

[[Page 16559]]

instantaneously available for public view on Regulations.gov. If you 
have received a Comment Tracking Number, your comment has been 
successfully submitted and there is no need to resubmit the same 
comment.
     Paper comments: Paper comments that duplicate electronic 
submissions are not necessary. Should you wish to mail a paper comment, 
in lieu of an electronic comment, it should be sent via regular or 
express mail to: Drug Enforcement Administration, Attn: DEA Federal 
Register Representative/DPW, 8701 Morrissette Drive, Springfield, 
Virginia 22152.

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

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA) for public inspection online at https://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter. The Freedom of Information Act applies to all comments 
received. If you want to submit personal identifying information (such 
as your name, address, etc.) as part of your comment, but do not want 
it to be made publicly available, you must include the phrase 
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your 
comment. You must also place all of the personal identifying 
information you do not want made publicly available in the first 
paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified as directed above will be 
made publicly available in redacted form. If a comment has so much 
confidential business information that it cannot be effectively 
redacted, all or part of that comment may not be made publicly 
available. Comments posted to https://www.regulations.gov may include 
any personal identifying information (such as name, address, and phone 
number) included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this proposed rule is available at https://www.regulations.gov for easy reference.

Legal Authority

    The Controlled Substances Act (CSA) gives the Attorney General the 
authority to specify, by regulation, a chemical as a list I chemical. 
21 U.S.C. 802(34). The term ``list I chemical'' means a chemical that 
is used in manufacturing a controlled substance in violation of the CSA 
and is important to the manufacture of the controlled substance. Id. 
Pursuant to 28 CFR 0.100(b), the Attorney General has delegated his 
authority to designate list I chemicals to the Administrator of DEA 
(Administrator).
    The DEA regulations set forth the process by which DEA may add a 
chemical as a listed chemical. As set forth in 21 CFR 1310.02(c), the 
agency may do so by publishing a final rule in the Federal Register 
following a published notice of proposed rulemaking with at least 30 
days for public comments. The current list of all list I chemicals is 
available in 21 CFR 1310.02(a).
    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. The 1988 Convention also requires the United States to 
take other specified measures related to that chemical, including 
measures related to its international trade.

Background

    By letter dated May 7, 2020, in accordance with Article 12, 
paragraph 6 of the 1988 Convention, the Secretary-General of the United 
Nations informed the United States Government that the chemical methyl 
alpha-phenylacetoacetate (MAPA), including its optical isomers, was 
added to Table I of the 1988 Convention. This letter was prompted by a 
March 4, 2020, decision at the 63rd Session of the United Nations 
Commission on Narcotic Drugs (CND) to add MAPA to Table I. As discussed 
above, the United States is a party to the 1988 Convention, and has 
certain obligations pursuant to Article 12. By designating MAPA as a 
list I chemical, the United States will fulfill its obligations under 
the 1988 Convention.
    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. 
Throughout the 1970s, methamphetamine was illicitly produced in the 
United States, primarily with the precursor chemical P2P. In response 
to the illicit use of P2P, DEA controlled P2P as a schedule II 
controlled substance in 1980 pursuant to the ``immediate precursor'' 
provisions of the CSA, specifically 21 U.S.C. 811(e).\1\ Clandestine 
laboratory operators have circumvented this control by developing a 
variety of synthetic methods for producing P2P.
---------------------------------------------------------------------------

    \1\ 44 FR 7182 (Feb. 11, 1980).
---------------------------------------------------------------------------

    Congress and DEA responded by placing controls on precursor 
chemicals used in the illicit production of P2P, such as phenylacetic 
acid (and its salts and esters), acetic anhydride, benzyl cyanide, 
benzaldehyde, and nitroethane.2 3 However, clandestine 
laboratory operators circumvented these controls by using alternative 
precursors that avoid the production of P2P: Ephedrine and 
pseudoephedrine for the production of methamphetamine; and 
phenylpropanolamine for the production of amphetamine. This led 
Congress and DEA to place stringent controls on the manufacture, 
distribution, importation, and exportation of ephedrine (its salts, 
optical isomers, and salts of optical isomers), pseudoephedrine, and 
phenylpropanolamine (controlled as list I chemicals), and 
pharmaceutical products containing these chemicals through the Combat 
Methamphetamine Epidemic Act of 2005 (Title VII of the USA PATRIOT Act 
Improvement and Reauthorization Act of 2005, Pub. L. 109-117), the 
Methamphetamine Production Prevention Act of 2008 (Pub.

[[Page 16560]]

L. 110-415), and the Combat Methamphetamine Act of 2010 (Pub. L. 111-
268).\4\ The international community soon took similar measures.
---------------------------------------------------------------------------

    \2\ On November 18, 1988, the Chemical Diversion and Trafficking 
Act (Subtitle A of Title VI of Pub. L. 100-690) was enacted.
    \3\ Under 21 CFR 1310.02(a), benzaldehyde, benzyl cyanide, 
nitroethane, and phenylacetic acid (including its salts and esters) 
are list I chemicals. Under 21 CFR 1310.02(b), acetic anhydride is a 
list II chemical.
    \4\ DEA implemented the Combat Methamphetamine Epidemic Act of 
2005, the Methamphetamine Production Prevention Act of 2008, and the 
Combat Methamphetamine Enhancement Act of 2010 in a series of 
interim and final rules. 72 FR 17401 (Apr. 9, 2007), 72 FR 28601 
(May 22, 2007), 73 FR 73549 (Dec. 3, 2008), 73 FR 79318 (Dec. 29, 
2008), 75 FR 4973 (Feb. 1, 2010), 75 FR 10168 (Mar. 5, 2010), 75 FR 
38915 (Jul. 7, 2010), 76 FR 20518 (Apr. 13, 2011), and 76 FR 74696 
(Dec. 1, 2011).
---------------------------------------------------------------------------

    With the growing problem of illicit drug production, the issue of 
precursor chemical control has gained global attention. International 
controls on precursors were first established under Article 12 of the 
1988 Convention, which established two categories of controlled illicit 
drug precursor substances: Table I and Table II.\5\ International 
efforts to prevent the illicit production of amphetamine-type 
stimulants (including amphetamine and methamphetamine), and 
international control of precursors, have since made significant 
progress. Two international entities have played a crucial role in this 
effort: The CND and the International Narcotics Control Board (INCB). 
The CND meets annually to consider and adopt a range of decisions and 
resolutions related to international drug control treaties, including 
the 1988 Convention. The INCB is an independent, quasi-judicial expert 
body for the implementation of the international drug control treaties, 
including the 1988 Convention.
---------------------------------------------------------------------------

    \5\ Table I and Table II are annexed to the Convention.
---------------------------------------------------------------------------

    In response to domestic and international controls on amphetamine 
and methamphetamine precursors, clandestine laboratory operators have 
continued to explore alternate methods of making these illicit drugs, 
including developing techniques to manufacture their own precursors and 
diverting other precursors to produce these precursors. The INCB 
reported the emergence of MAPA in late 2017, noting its use as a 
precursor for the production of P2P.\6\ The emergence and increase in 
encounters of MAPA are linked to increased scrutiny over other P2P 
precursors, such as alpha-phenylacetoacetamide (APAA).\7\ Although MAPA 
does not have any legitimate use and it has not been widely traded 
through legitimate channels, it is advertised by online suppliers.\8\ 
Clandestine laboratory operators currently use MAPA to manufacture P2P, 
which they then convert to methamphetamine and amphetamine.
---------------------------------------------------------------------------

    \6\ 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.
    \7\ Id.
    \8\ Id.
---------------------------------------------------------------------------

MAPA

    MAPA is known as methyl alpha-phenylacetoacetate; methyl 3-oxo-2-
phenylbutanoate; methyl 2-phenylacetoacetate; [alpha]-acetyl-
benzeneacetic acid, methyl ester; and CAS Number: 16648-44-5. MAPA 
first emerged in late 2017 with the Netherlands reporting seizures 
totaling nearly 490 kg on Form D.\9\ Belgium followed in 2018 with 
reports through the Precursors Incident Communication System (PICS) of 
more than 550 kg of MAPA seized.\10\ China was reported as the alleged 
origin for all of the incidents in the Netherlands or Belgium where the 
origin was provided. The INCB reported an increase in the frequency of 
seizures and amounts seized reported through PICS since November 
2018.\11\
---------------------------------------------------------------------------

    \9\ Member countries use Form D to report to INCB annual 
information on substances frequently used in the illicit manufacture 
of narcotic drugs and psychotropic substances.
    \10\ 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.
    \11\ Id.
---------------------------------------------------------------------------

    MAPA is a close chemical relative of precursors controlled under 
the 1988 Convention (e.g., APAAN and APAA) and the timing of its 
emergence suggests it is trafficked to circumvent these recent 
precursor controls. The INCB notes that MAPA does not have any 
legitimate use.\12\ DEA has not identified any known legitimate use for 
MAPA, other than in small amounts for research, development, and 
laboratory analytical purposes. Due to the lack of industrial uses of 
MAPA, the chemical has not been widely available from legitimate 
chemical suppliers. Since late 2017, however, there have been large 
international seizures of MAPA, primarily in Europe, which suggest 
there is a ready supply of MAPA from international chemical 
manufacturers. The only use for a large quantity of MAPA of which DEA 
is aware is as a primary precursor for conversion to P2P, and 
subsequent conversion to amphetamine or methamphetamine.
---------------------------------------------------------------------------

    \12\ Id.
---------------------------------------------------------------------------

    Between late 2017, and May 7, 2019, the INCB noted 29 incidents 
from PICS where MAPA was seized. The amount of MAPA seized in 
individual incidents ranged from 500 grams to 2 metric tons, and 
totaled more than 10.5 metric tons. All incidents reported in PICS 
occurred in Europe, or involved shipments of MAPA destined for 
countries in Europe.
    DEA has determined that MAPA is now readily available from 
commercial chemical suppliers and has identified seven potential 
suppliers in China, five potential suppliers in the United States, 
three potential suppliers in the United Kingdom, and one potential 
supplier each in France, Hong Kong, and Latvia.
    DEA is concerned about the ease with which MAPA serves as a 
precursor chemical for illicit controlled substance production and with 
the international trafficking in this chemical. The international 
community shares this concern. The INCB found ``that MAPA is frequently 
used in the illicit manufacture of amphetamine-type stimulants, namely 
amphetamine, and that the volume and extent of the illicit manufacture 
of amphetamine-type stimulants pose serious public health or social 
problems so as to warrant international action.'' \13\ Based in part on 
the findings of the INCB, and as noted above, the CND has added MAPA to 
Table I of the 1988 Convention. Therefore, DEA is proposing the 
designation of MAPA as a list I chemical.
---------------------------------------------------------------------------

    \13\ Notification from the President of the INCB to the Chair of 
the CND on its sixty-third session concerning the scheduling of MAPA 
under the 1988 Convention, Nov. 12, 2019, at 1.
---------------------------------------------------------------------------

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

    For the reasons discussed above, the Acting Administrator of DEA 
finds that MAPA is used in the manufacture of controlled substances 
(i.e., schedule II substances P2P, methamphetamine, and amphetamine) in 
violation of the CSA and is important to the manufacture of these 
controlled substances. Laboratory operators are using MAPA as the 
precursor material for the illicit manufacture of P2P, methamphetamine, 
and amphetamine. Therefore, the Acting Administrator proposes the 
designation of MAPA as a list I chemical.
    If finalized, handlers of MAPA would become subject to the chemical 
regulatory provisions of the CSA, including 21 CFR parts 1309, 1310, 
1313, and 1316. Since 1 gram of MAPA could make approximately 1 gram of 
methamphetamine hydrochloride, which is equivalent to approximately 200 
tablets containing 5 milligrams of methamphetamine hydrochloride, this 
action does not propose the establishment of a threshold for domestic 
and import transactions of MAPA in accordance with the

[[Page 16561]]

provisions of 21 CFR 1310.04(g). Therefore, DEA is proposing that all 
MAPA transactions, regardless of size, would be regulated transactions 
as defined in 21 CFR 1300.02(b). As such, if finalized, all MAPA 
transactions would be subject to recordkeeping, reporting, import and 
export controls, and other CSA chemical regulatory requirements. In 
addition, each regulated bulk manufacturer must submit manufacturing, 
inventory, and use data on an annual basis, in accordance with 21 CFR 
1310.05(d).

Chemical Mixtures of MAPA

    This rulemaking also proposes that chemical mixtures containing 
MAPA would not be exempt from regulatory requirements at any 
concentration, unless a manufacturer submits to DEA an application for 
exemption of such chemical mixture, DEA accepts the application for 
filing, and DEA exempts the chemical mixture in accordance with 21 CFR 
1310.13 (Exemption of chemical mixtures by application). Since 1 gram 
of MAPA could make approximately 1 gram of methamphetamine 
hydrochloride, which is equivalent to approximately 200 tablets 
containing 5 milligrams of methamphetamine hydrochloride, regulation of 
chemical mixtures containing any amount of MAPA is necessary to prevent 
the illicit extraction, isolation, and use of MAPA. Therefore, all 
chemical mixtures containing any quantity of MAPA would be subject to 
control under the CSA, unless a manufacturer of MAPA is granted an 
exemption by the application process in accordance with 21 CFR 1310.13. 
This rulemaking proposes 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 MAPA 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.\14\ 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.
---------------------------------------------------------------------------

    \14\ 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.
---------------------------------------------------------------------------

Requirements for Handling List I Chemicals

    If finalized as proposed, the designation of MAPA as a list I 
chemical would subject handlers (manufacturers, distributors, 
importers, and exporters) and proposed handlers to all of the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to the manufacture, distribution, importing, and exporting 
of a list I chemical. Upon publication of a final rule, persons 
potentially handling MAPA, including regulated chemical mixtures 
containing MAPA, would be required to comply with the following list I 
chemical regulations:
    1. Registration. Any person who handles (manufactures, distributes, 
imports, or exports), or proposes to engage in such handling of, 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.\15\ 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.\16\
---------------------------------------------------------------------------

    \15\ 21 CFR 1309.21.
    \16\ 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.
---------------------------------------------------------------------------

    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.\17\ 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.\18\ 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.
---------------------------------------------------------------------------

    \17\ 21 U.S.C. 822(c)(2) and 21 U.S.C. 957(b)(1)(B).
    \18\ See 21 CFR 1309.23(b)(1).
---------------------------------------------------------------------------

    Upon publication of a final rule, any person manufacturing, 
distributing, importing, or exporting MAPA or a chemical mixture 
containing MAPA would become subject to the registration requirement 
under the CSA. DEA recognizes, however, that it is not possible for 
persons who are subject to the registration requirements to immediately 
complete and submit an application for registration and for DEA to 
immediately issue registrations for those activities. Therefore, to 
allow any continued legitimate commerce in MAPA, DEA is proposing to 
establish in 21 CFR 1310.09 a temporary exemption from the registration 
requirement for persons desiring to engage in activities with MAPA, 
provided that DEA receives a properly completed application for 
registration on or before 30 days after publication of a final rule 
implementing regulations regarding MAPA. The temporary exemption for 
such persons would remain in effect until DEA takes final action on 
their application for registration or application for exemption of a 
chemical mixture.
    The temporary exemption would apply solely to the registration 
requirement; all other chemical control requirements, including 
recordkeeping and reporting, would become effective on the effective 
date of the final rule. Therefore, all transactions of MAPA and 
chemical mixtures containing MAPA would be regulated while an 
application for registration or exemption is pending. This is necessary 
because a delay in regulating these transactions could result in 
increased diversion of chemicals desirable to drug traffickers.
    Additionally, the temporary exemption for registration does not 
suspend applicable Federal criminal laws relating to 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 would be required to 
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 would be 
required to submit manufacturing, inventory, and

[[Page 16562]]

use data on an annual basis.\19\ Existing standard industry reports 
containing the required information would be acceptable, provided the 
information is separate or readily retrievable from the report.
---------------------------------------------------------------------------

    \19\ 21 CFR 1310.05(d).
---------------------------------------------------------------------------

    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.\20\
---------------------------------------------------------------------------

    \20\ 21 U.S.C. 830(b) and 21 CFR 1310.05(a) and (b).
---------------------------------------------------------------------------

    3. Importation and Exportation. All importation and exportation of 
MAPA would need to be 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 would be required to 
provide effective controls against theft and diversion of list I 
chemicals in accordance with 21 CFR 1309.71-1309.73.
    5. Administrative Inspection. Places, including factories, 
warehouses, or other establishments and conveyances, where registrants 
or other regulated persons may lawfully hold, manufacture, distribute, 
or otherwise dispose of a list I chemical or where records relating to 
those activities are maintained, are controlled premises as defined in 
21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for 
administrative inspections of these controlled premises as provided in 
21 CFR part 1316, subpart A.\21\
---------------------------------------------------------------------------

    \21\ 21 U.S.C. 880.
---------------------------------------------------------------------------

    6. Liability. Any activity involving MAPA not authorized by, or in 
violation of, the CSA would be unlawful, and would subject the person 
to administrative, civil, and/or criminal action.

Regulatory Analyses

Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    This proposed 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 proposed rule is not a ``significant regulatory action'' 
under E.O. 12866, section 3(f).
    If finalized as proposed, MAPA would be subject to all of the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to the manufacture, distribution, importing, and exporting 
of list I chemicals. MAPA 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 MAPA except for it being a chemical 
intermediate in the production of the schedule II substances P2P, 
methamphetamine, and amphetamine. Based on the review of established 
aggregate production quota for P2P (40 grams for 2019), 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, if there are 
any quantities of MAPA used for the manufacturing of legitimate P2P, 
the quantities are believed to be minimal. DEA welcomes any public 
comment on these quantities and their economic significance.
    DEA evaluated the costs and benefits of this proposed action.
Costs
    DEA believes the market for MAPA for the legitimate manufacturing 
of pharmaceutical amphetamine or methamphetamine is minimal. 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, 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 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. As there are different 
forms of handling the scheduled substances versus the list I chemical 
(distribution of P2P, methamphetamine, and amphetamine versus exporting 
MAPA), 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 with the scheduled substance, or as a 
coincident activity permitted by Sec.  1309.21. Even with the 
possibility of these additional registrations, DEA believes that the 
cost would be minimal.

[[Page 16563]]

    DEA has identified five domestic suppliers of MAPA, only one of 
which is registered with DEA to handle list I chemicals. It is 
difficult to estimate the quantity of MAPA these suppliers distribute. 
Chemical distributors often have items in their catalog while not 
actually having any material level of sales. If this proposed rule is 
finalized, suppliers for the legitimate use of MAPA, if any, are 
expected to choose the least-cost option, and stop selling the minimal 
quantities of MAPA, rather than incur the registration cost. Because 
DEA believes the quantities of MAPA supplied for the legitimate 
manufacturing of P2P, methamphetamine, and amphetamine are minimal, DEA 
estimates that the cost of foregone sales is minimal; and thus, the 
cost of this proposed rule is minimal. DEA welcomes any public comment 
regarding this estimate.
    This analysis excludes consideration of any economic impact to 
those businesses that facilitate the manufacture and distribution of 
MAPA 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 MAPA is expected to prevent, curtail, and limit the 
unlawful manufacture and distribution of the controlled substances P2P, 
methamphetamine, and amphetamine. As a list I chemical, handling of 
MAPA would require registration with DEA, various controls, and 
monitoring as required by the CSA. This proposed rule is also expected 
to assist in preventing the possible theft or diversion of 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 proposed action, if finalized, will 
minimize the diversion of MAPA. DEA believes the market for MAPA for 
the legitimate manufacturing of P2P, methamphetamine, and amphetamine 
is minimal. Therefore, any potential cost as a result of this 
regulation is minimal.

Executive Order 12988, Civil Justice Reform

    This proposed regulation meets the applicable standards set forth 
in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors 
and ambiguity, minimize litigation, provide a clear legal standard for 
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

    This proposed rulemaking does not have federalism implications 
warranting the application of E.O. 13132. The proposed rule does not 
have substantial direct effects on the States, on the relationship 
between the national government and the States, or the distribution of 
power and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This proposed rule does not have tribal implications warranting the 
application of E.O. 13175. It does not have substantial direct effects 
on one or more Indian tribes, on the relationship between the Federal 
Government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.

Regulatory Flexibility Act

    The Acting Administrator, in accordance with the Regulatory 
Flexibility Act (RFA),\22\ has reviewed this proposed rule and by 
approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. As discussed above, 
if finalized as proposed, MAPA would be subject to all of the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to the manufacture, distribution, importation, and 
exportation of list I chemicals. 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. Based on 
the review of established aggregate production quota for P2P, 40 grams 
for 2019, 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 proposed rule are the annual 
registration fees ($3,699 for manufacturers and $1,850 for 
distributors, importers, and exporters). Additionally, 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 in place, resulting in minimal cost.
---------------------------------------------------------------------------

    \22\ 5 U.S.C. 601-612.
---------------------------------------------------------------------------

    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. It is difficult to estimate the quantity of MAPA 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 (40 grams 
for 2019), 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. Therefore, DEA estimates the cost of this proposed rule on any 
affected small entity is minimal. DEA welcomes any public comment 
regarding this estimate. Based on these factors, DEA projects that this 
proposed rule, if promulgated, will not result in a significant 
economic impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    On the basis of information contained in the RFA section above, DEA 
has determined and certifies pursuant to the Unfunded Mandates Reform 
Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., that this action would not 
result in any Federal mandate that may result ``in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any 1 year * * *.'' Therefore, neither a Small Government 
Agency Plan nor any other action is required under provisions of UMRA.

[[Page 16564]]

Paperwork Reduction Act

    This proposed action does not impose a new collection of 
information requirement under the Paperwork Reduction Act, 44 U.S.C. 
3501-3521. This proposed action would not impose recordkeeping or 
reporting requirements on State or local governments, individuals, 
businesses, or organizations. 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 
proposes to further amend 21 CFR part 1310, as proposed to be amended 
at 85 FR 82984 (December 21, 2020) as follows:

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

0
1. The authority citation for 21 CFR part 1310 continues to read as 
follows:

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

0
2. In Sec.  1310.02, add paragraph (a)(37) to read as follows:


Sec.  1310.02  Substances covered.

* * * * *
    (a) * * *

(37) methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-           8795
 2-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 30 days after the publication of a rule finalizing 
this action. The exemption would remain in effect for each person who 
has made such application until the Administration has approved or 
denied that application. This exemption applies only to registration; 
all other chemical control requirements set forth in the Act and parts 
1309, 1310, 1313, and 1316 of this chapter remain in full force and 
effect.
    (2) Any person who manufactures, distributes, imports, or exports a 
chemical mixture containing regulated forms of 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                       concentration.              containing any amount of
 its optical isomers.                                                                  MAPA and its optical
                                                                                       isomers are not exempt.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


[[Page 16565]]

* * * * *

D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-05346 Filed 3-29-21; 8:45 am]
BILLING CODE 4410-09-P