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

CourtDrug Enforcement Administration
Citation86 FR 16558
Record Number2021-05346
Publication Date30 Mar 2021
16558
Federal Register / Vol. 86, No. 59 / Tuesday, March 30, 2021 / Proposed Rules
these 28 registrations represent 22
entities. Some of these entities are likely
to be large entities. However, since DEA
does not have information of registrant
size and the majority of DEA registrants
are small entities or are employed by
small entities, DEA estimates a
maximum of 22 entities are small
entities. Therefore, DEA conservatively
estimates as many as 22 small entities
are affected by this proposed rule.
A review of the 28 registrations
indicates that all entities that currently
handle 5F-EDMB-PINACA, 5F-MDMB-
PICA, FUB-AKB48, 5F-CUMYL-PINACA
or FUB-144 also handle other schedule
I controlled substances, and have
established and implemented (or
maintain) the systems and processes
required to handle 5F-EDMB-PINACA,
5F-MDMB-PICA, FUB-AKB48, 5F-
CUMYL-PINACA and FUB-144.
Therefore, DEA anticipates that this
proposed rule will impose minimal or
no economic impact on any affected
entities; and thus, will not have a
significant economic impact on any of
the 22 affected small entities. Therefore,
DEA has concluded that this proposed
rule will not have a significant effect on
a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded
Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has
determined and certifies 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 million or more
(adjusted annually for inflation) in any
1 year * * *.’’ Therefore, neither a
Small Government Agency Plan nor any
other action is required under UMRA of
1995.
Paperwork Reduction Act of 1995
This action does not impose a new
collection of information under the
Paperwork Reduction Act of 1995. 44
U.S.C. 3501–3521. This 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 1308
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
For the reasons set out above, DEA
proposes to amend 21 CFR part 1308 as
follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for part 1308
continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b),
956(b), unless otherwise noted.
2. In § 1308.11,
a. Add paragraphs (d)(87) through
(d)(91); and
b. Remove and reserve paragraphs
(h)(37) through (41).
The additions to read as follows:
§ 1308.11 Schedule I.
* * * * *
(d) * * *
(87) ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-EDMB-PINACA) .......... 7036
(88) methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA) ............... 7041
(89) N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48
N-(4-FLUOROBENZYL)) ................................................................................................................................................................. 7047
(90) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide (trivial names: 5F-CUMYL-PINACA; SGT-25) ... 7083
(91) (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (trivial name: FUB-144) ............................. 7014
* * * * *
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021–06553 Filed 3–29–21; 8:45 am]
BILLING CODE 4410–09–P
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; a-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
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1
44 FR 7182 (Feb. 11, 1980).
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.
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.
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.
23
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.
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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).
5
Table I and Table II are annexed to the
Convention.
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.
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.
12
Id.
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.
L. 110–415), and the Combat
Methamphetamine Act of 2010 (Pub. L.
111–268).
4
The international
community soon took similar measures.
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.
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.
MAPA
MAPA is known as methyl alpha-
phenylacetoacetate; methyl 3-oxo-2-
phenylbutanoate; methyl 2-
phenylacetoacetate; a-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
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.
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.
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
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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.
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.
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).
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.
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
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.
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
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19
21 CFR 1310.05(d).
20
21 U.S.C. 830(b) and 21 CFR 1310.05(a) and (b).
21
21 U.S.C. 880.
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.
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
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
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 § 1309.21. Even with the
possibility of these additional
registrations, DEA believes that the cost
would be minimal.
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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. 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.
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.
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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
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.
2. In § 1310.02, add paragraph (a)(37)
to read as follows:
§ 1310.02 Substances covered.
* * * * *
(a) * * *
(37) methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate) and its optical isomers ................................ 8795
* * * * *
3. In § 1310.04:
a. Redesignate paragraphs (g)(1)(x)
through (xvi) as paragraphs (g)(1)(xi)
through (xvii), respectively; and
b. Add new paragraph (g)(1)(x).
The addition reads as follows:
§ 1310.04 Maintenance of records.
* * * * *
(g) * * *
(1) * * *
(x) methyl alpha-phenylacetoacetate
(MAPA; methyl 3-oxo-2-
phenylbutanoate) and its optical
isomers.
* * * * *
4. In § 1310.09, add paragraph (r) to
read as follows:
§ 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 § 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 § 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.
5. In § 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:
§ 1310.12 Exempt chemical mixtures.
* * * * *
(c) * * *
T
ABLE OF
C
ONCENTRATION
L
IMITS
DEA chemical
code No. Concentration Special conditions
List I Chemicals
*******
methyl alpha-phenylacetoacetate (MAPA;
methyl 3-oxo-2-phenylbutanoate) and its
optical isomers.
8795 Not exempt at any concentration ... Chemical mixtures containing any amount
of MAPA and its optical isomers are not
exempt.
*******
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* * * * *
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021–05346 Filed 3–29–21; 8:45 am]
BILLING CODE 4410–09–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR PART 52
[EPA–R05–OAR–2020–0559; FRL–10022–
19–Region 5]
Air Plan Approval; Ohio; Ohio NSR
Permit Timing
AGENCY
: Environmental Protection
Agency (EPA).
ACTION
: Proposed rule; re-opening of
public comment period.
SUMMARY
: The Environmental Protection
Agency (EPA) is re-opening the
comment period for a proposed rule
published February 11, 2021. On
February 11, 2021, EPA proposed to
approve, under the Clean Air Act, an
Ohio rule that would allow for the
extension of an installation permit
which is the subject of an appeal by a
party other than the owner or operator
of the air contaminant source. In
response to requests from members of
the public, EPA is re-opening the
comment period for an additional 30
days.
DATES
: Comments must be received on
or before April 29, 2021.
ADDRESSES
: Submit comments,
identified by Docket ID No. EPA–R05–
OAR–2020–0559, to: Genevieve Damico,
Chief, Air Permits Section, Air Programs
Branch (AR–18J), U.S. Environmental
Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois
60604, damico.genevieve@epa.gov.
Additional instructions regarding how
to submit a comment can be found in
the notice of proposed rulemaking
published February 11, 2021 (86 FR
9039).
FOR FURTHER INFORMATION CONTACT
: Mari
Gonza
´lez, Environmental Engineer, Air
Permits Section, Air Programs Branch
(AR–18J), Environmental Protection
Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,
(312) 886–6175, Gonzalez.Mari@
epa.gov.
Dated: March 24, 2021.
Cheryl Newton,
Acting Regional Administrator, Region 5.
[FR Doc. 2021–06449 Filed 3–29–21; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 10 and 11
[PS Docket Nos. 15–94 and 15–91; FCC 21–
36; FRS 17864]
Emergency Alert System, Wireless
Emergency Alerts; National Defense
Authorization Act for Fiscal Year 2021,
Delivering Alerts Via the Internet,
Including Through Streaming Services
AGENCY
: Federal Communications
Commission.
ACTION
: Proposed rule and inquiry.
SUMMARY
: In this document, the
Commission, takes actions
implementing section 9201 of the
National Defense Authorization Act for
Fiscal Year 2021, exploring
opportunities to improve the way the
public receives emergency alerts from
the nation’s Emergency Alert System
(EAS) and Wireless Emergency Alerts
System (WEA) on their mobile phones,
televisions, and radios. We propose
rules to ensure that more people receive
relevant emergency alerts, to enable
EAS and WEA participants to report
false alerts when they occur, and to
improve the way states plan for
emergency alerts. In addition, we
initiate an inquiry to examine the
feasibility of updating the EAS to enable
or improve alerts to consumers provided
through the internet, including through
streaming services, and from radio and
television stations, cable systems,
satellite radio and television providers,
and wireline video providers that
currently participate in EAS. As
directed by Congress, after the
conclusion of this inquiry the
Commission will submit a report on its
findings and conclusions to specified
Committees of the U.S. Senate and
House of Representatives.
DATES
: Comments on the Notice of
Proposed Rulemaking are due on or
before April 20, 2021, and reply
comments are due on or before May 4,
2021. Comments on the Notice of
Inquiry are due on or before May 14,
2021, and reply comments are due on or
before June 14, 2021.
ADDRESSES
: You may submit comments,
identified by PS Docket Nos. 15–94 and
15–91, by any of the following methods:
Federal Communications
Commission’s website: http://
apps.fcc.gov/ecfs/. Follow the
instructions for submitting comments.
Mail: Parties who choose to file by
paper must file an original and one copy
of each filing. If more than one docket
or rulemaking number appears in the
caption of this proceeding, filers must
submit two additional copies for each
additional docket or rulemaking
number. Filings can be sent by
commercial overnight courier, or by
first-class or overnight U.S. Postal
Service mail. All filings must be
addressed to the Commission’s
Secretary, Office of the Secretary,
Federal Communications Commission.
Commercial overnight mail (other than
U.S. Postal Service Express Mail and
Priority Mail) must be sent to 9050
Junction Drive, Annapolis Junction, MD
20701. U.S. Postal Service first-class,
Express, and Priority mail must be
addressed to 45 L Street NE,
Washington, DC 20554.
People with Disabilities: Contact the
FCC to request reasonable
accommodations (accessible format
documents, sign language interpreters,
CART, etc.) by email: FCC504@fcc.gov
or phone: 202–418–0530 or TTY: 202–
418–0432.
For detailed instructions for
submitting comments and additional
information on the rulemaking process,
see the
SUPPLEMENTARY INFORMATION
section of this document.
FOR FURTHER INFORMATION CONTACT
:
Regarding the notice of proposed
rulemaking, Christopher Fedeli,
Attorney Advisor, Public Safety and
Homeland Security Bureau at 202–418–
1514 or Christopher.Fedeli@fcc.gov;
regarding the notice of inquiry, James
Wiley, Attorney-Advisor, Public Safety
and Homeland Security Bureau,
Cybersecurity and Communications
Reliability Division at (202) 418–1678 or
James.Wiley@fcc.gov.
SUPPLEMENTARY INFORMATION
: This is a
summary of the Commission’s Notice of
Proposed Rulemaking and Notice of
Inquiry, FCC 21–36, in PS Docket Nos.
15–94 and 15–91, adopted on March 17,
2021 and released on March 19, 2021.
The full text of this document is
available at https://docs.fcc.gov/public/
attachments/FCC-21-36A1.pdf.
Pursuant to §§ 1.415 and 1.419 of the
Commission’s rules, 47 CFR 1.415,
1.419, interested parties may file
comments and reply comments on or
before the dates indicated on the first
page of this document. Comments may
be filed using the Commission’s
Electronic Comment Filing System
(ECFS). See Electronic Filing of
Documents in Rulemaking Proceedings,
63 FR 24121 (1998).
Electronic Filers: Comments may be
filed electronically using the internet by
accessing the ECFS: http://apps.fcc.gov/
ecfs/.
Paper Filers: Parties who choose to
file by paper must file an original and
one copy of each filing.
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