Designation of Methyl alpha-phenylacetoacetate, a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical
| Published date | 30 March 2021 |
| Citation | 86 FR 16558 |
| Record Number | 2021-05346 |
| Section | Proposed rules |
| Court | Drug Enforcement Administration |
Federal Register, Volume 86 Issue 59 (Tuesday, March 30, 2021)
[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 http://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 http://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 http://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 http://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
