Designation of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), and alpha-phenylacetoacetamide (APAA) as List I Chemicals
| Published date | 10 May 2021 |
| Citation | 86 FR 24703 |
| Record Number | 2021-09697 |
| Section | Rules and Regulations |
| Court | Drug Enforcement Administration,Justice Department |
Federal Register, Volume 86 Issue 88 (Monday, May 10, 2021)
[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Rules and Regulations]
[Pages 24703-24708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09697]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-542]
Designation of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-
MDP-2-P methyl glycidic acid (PMK glycidic acid), and alpha-
phenylacetoacetamide (APAA) as List I Chemicals
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration is finalizing a December
21, 2020, notice of proposed rulemaking to designate three chemicals,
known as PMK glycidate, PMK glycidic acid, and APAA, as list I
chemicals under the Controlled Substances Act (CSA). PMK glycidate and
PMK glycidic acid are used in and are important to the manufacture of
the schedule I controlled substance 3,4-methylenedioxymethamphetamine
(MDMA) and other ``ecstasy''-type substances, and APAA is used in and
is important to the manufacture of the schedule II controlled
substances amphetamine and methamphetamine. This final rulemaking
subjects handlers (manufacturers, distributors, importers, and
exporters) of PMK glycidate, PMK glycidic acid, and APAA to the
chemical regulatory provisions of the CSA and its implementing
regulations.
DATES: Effective June 9, 2021.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone: (571) 362-3249.
[[Page 24704]]
SUPPLEMENTARY INFORMATION: This final rule designates the following
chemicals as list I chemicals and subjects them to the regulatory
requirements applicable to list I chemicals:
3,4-MDP-2-P methyl glycidate (PMK glycidate), including
its optical and geometric isomers;
3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid),
including its salts, optical and geometric isomers, and salts of
isomers; and
alpha-phenylacetoacetamide (APAA), including its optical
isomers,.
Legal Authority
The Controlled Substances Act (CSA) and the Drug Enforcement
Administration's (DEA) implementing regulations give the Attorney
General, as delegated to the Administrator of DEA, the authority to
specify, by regulation, a chemical as a ``list I chemical.'' \1\ This
term refers to a chemical that is used in manufacturing a controlled
substance in violation of subchapter I (Control and Enforcement) of the
CSA and is important to the manufacture of the controlled substance.\2\
The current list of all list I chemicals is available in 21 CFR
1310.02(a).
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\1\ 21 U.S.C. 802(34) and 871(b) and 21 CFR 1310.02(c).
\2\ 21 U.S.C. 802(34) and 21 CFR 1300.02(b).
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In addition, the United States is a Party to the 1988 United
Nations Convention against Illicit Traffic in Narcotic Drugs and
Psychotropic Substances (1988 Convention), December 20, 1988, 1582
U.N.T.S. 95. Under Article 12 of the 1988 Convention, when the United
States receives notification that a chemical has been added to Table I
or Table II (tables annexed to such Convention), the United States must
take measures it deems appropriate to monitor the manufacture and
distribution of that chemical within the United States and to prevent
its diversion, including measures related to international trade.
Background
In a letter dated May 23, 2019, the Secretary-General of the United
Nations, in accordance with Article 12, paragraph 6 of the 1988
Convention, informed the United States Secretary of State that the
Commission on Narcotic Drugs (CND) voted to place the chemicals 3,4-
MDP-2-P methyl glycidate (PMK glycidate) (and all stereoisomers), 3,4-
MDP-2-P methyl glycidic acid (PMK glycidic acid) (and all
stereoisomers), and alpha-phenylacetoacetamide (APAA) (and all optical
isomers) in Table I of the 1988 Convention (CND Decisions 62/10, 62/11,
and 62/12, respectively) at its 62nd Session on March 19, 2019.
On December 21, 2020, DEA published a notice of proposed rulemaking
(NPRM) [85 FR 82984] to designate 3,4-MDP-2-P methyl glycidate (PMK
glycidate), including its optical and geometric isomers; 3,4-MDP-2-P
methyl glycidic acid (PMK glycidic acid), including its salts, optical
and geometric isomers, and salts of isomers; and alpha-
phenylacetoacetamide (APAA), including its optical isomers, as list I
chemicals under the CSA.\3\
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\3\ DEA proposed to control the same set of chemicals specified
by the CND. However, DEA used more precise terms that relate to the
specific chemical and variations that can actually exist.
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PMK glycidate, PMK glycidic acid, and APAA are close chemical
relatives of controlled list I precursor 3,4 methylenedioxyphenyl-2-
propanone (3,4-MDP-2-P), and have been made specifically to circumvent
existing precursor controls. DEA has not identified any known
legitimate uses for these chemicals, other than possible research
purposes. The first two substances, PMK glycidate and PMK glycidic
acid, are closely related in chemical structure to precursors of 3,4-
methylenedioxymethamphetamine (MDMA) (schedule I) and other
``ecstasy''-type substances in schedule I. APAA is a precursor of
schedule II controlled substances amphetamine and methamphetamine.
All three chemicals are used for the illicit manufacture of two
precursors listed in Table I of the 1988 Convention (3,4-MDP-2-P and 1-
phenyl-2-propanone (P-2-P)). For years, countries have reported to the
International Narcotics Control Board (INCB) the illicit trafficking
and use of these chemicals in manufacturing controlled substances, with
increasing frequency and amounts reported in 2018 and 2019.\4\
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\4\ Precursors and Chemicals Frequently Used in the Illicit
Manufacture of Narcotic Drugs and Psychotropic Substances: Report of
the International Narcotics Control Board for 2018 on the
Implementation of Article 12 of the United Nations Convention
against Illicit Traffic in Narcotic Drugs and Psychotropic
Substances of 1988 (E/INCB/2018/4, Released March 5, 2019) and
Report of the International Narcotics Control Board for 2019 on the
Implementation of Article 12 of the United Nations Convention
against Illicit Traffic in Narcotic Drugs and Psychotropic
Substances of 1988 (E/INCB/2019/1, Released February 27. 2020)
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Comments Received and Designation of PMK Glycidate, PMK Glycidic Acid,
and APAA as List I Chemicals
In response to the December 21, 2020, NPRM, DEA received one
anonymous comment expressing general opposition to the ``war on drugs''
and to the addition of more substances to the list and under CSA
control. DEA considers the general comment about the war on drugs to be
outside the scope of this rulemaking.
Regarding the general opposition to listing more substances, DEA
notes that it proposed to designate and add these three specific
chemicals to the list as they met the statutory and regulatory
definition of a list I chemical, and DEA is using its legal authority
to so designate these chemicals as list I chemicals.
Therefore, for the reasons discussed in the NPRM, and reiterated in
the above background section, the Acting Administrator of DEA finds
that PMK glycidate, PMK glycidic acid, and APAA are used in the
manufacture of controlled substances in violation of the CSA, and are
important to the manufacture of these controlled substances. Therefore,
the Acting Administrator designates PMK glycidate, PMK glycidic acid,
and APAA as list I chemicals.
Chemical Mixtures of PMK Glycidate, PMK Glycidic Acid or APAA
Pursuant to this final rulemaking, chemical mixtures containing any
of these three chemicals are subject to regulatory requirements at any
concentration unless a manufacturer submits to DEA an application for
exemption of a chemical mixture, DEA accepts the application for
filing, and DEA exempts the chemical mixture in accordance with 21 CFR
1310.13 (Exemption of chemical mixtures; application). Since even a
small amount of these three chemicals can potentially yield a
significant amount of controlled substances, DEA believes that
regulation of chemical mixtures containing any amount of these three
chemicals is necessary to prevent their illicit extraction, isolation,
and use. This rule modifies the ``Table of Concentration Limits'' in 21
CFR 1310.12(c) to reflect the fact that chemical mixtures containing
any amount of these three chemicals are subject to CSA chemical control
provisions, including 21 CFR parts 1309, 1310, 1313, and 1316.
Application Process for Exemption of Chemical Mixtures
DEA has implemented an application process to exempt certain
chemical mixtures from the requirements of the CSA and its implementing
regulations.\5\ Manufacturers may submit an
[[Page 24705]]
application for exemption for those mixtures that do not meet the
category criteria set forth in 21 CFR 1310.12(d) for an automatic
exemption. DEA may grant an exemption of a chemical mixture if the
Administrator determines that the mixture is formulated in such a way
that it cannot be easily used in the illicit production of a controlled
substance, and the listed chemical or chemicals contained in the
chemical mixture cannot be readily recovered (i.e., the chemical
mixture meets the conditions set forth in 21 U.S.C. 802(39)(A)(vi) and
21 CFR 1310.13(a)(1)-(2)).
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\5\ 21 CFR 1310.13 specifies that this chemical mixture is a
chemical mixture consisting of two or more chemical components, at
least one of which is not a list I or list II chemical, and the
mixture and its listed chemical(s) must meet certain other
conditions.
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Requirements for Handling List I Chemicals
The designation of these three chemicals as list I chemicals
subjects handlers (manufacturers, distributors, importers, and
exporters) and proposed handlers to all of the regulatory controls and
administrative, civil, and criminal actions applicable to the
manufacture, distribution, importation, and exportation of a list I
chemical. Upon the effective date of this final rulemaking, persons
potentially handling these three chemicals, including regulated
chemical mixtures containing any of these three chemicals, are required
to comply with the following list I chemical regulations:
1. Registration. Any person who handles (manufactures, distributes,
imports, or exports), or proposes to engage in such handling of any of
these three chemicals must obtain a registration pursuant to 21 U.S.C.
822, 823, 957, and 958. Regulations describing registration for list I
chemical handlers are set forth in 21 CFR part 1309. DEA regulations
require separate registrations for manufacturing, distributing,
importing, and exporting of any of these three chemicals.\6\ Further, a
separate registration is required for each principal place of business
at one general physical location where list I chemicals are
manufactured, distributed, imported, or exported by a person.\7\
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\6\ 21 CFR 1309.21.
\7\ 21 CFR 1309.23(a). See also 21 U.S.C. 822(e)(1) with
separate registration requirements pertaining to manufacturing or
distributing a list I chemical.
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DEA notes that under the CSA, a ``warehouseman'' is not required to
register and may lawfully possess a list I chemical, if the possession
of the chemical is in the usual course of business or employment.\8\
Under DEA implementing regulations, the warehouse in question must
receive the list I chemical from a DEA registrant, and shall only
distribute the list I chemical back to the DEA registrant and
registered location from which it was received.\9\ A warehouse that
distributes list I chemicals to persons other than the registrant and
registered location from which they were obtained is conducting
distribution activities and is required to register as such.
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\8\ 21 U.S.C. 822(c)(2) and 21 U.S.C. 957(b)(1)(B).
\9\ See 21 CFR 1309.23(b)(1).
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Upon the effective date of this final rulemaking, any person
manufacturing, distributing, importing, or exporting any of these three
chemicals will become subject to the registration requirement under the
CSA. DEA recognizes, however, that it is not possible for persons
subject to the registration requirement to immediately complete and
submit an application for registration and for DEA to immediately issue
registrations for those activities. Therefore, to allow continued
legitimate commerce in these three chemicals, DEA is establishing in 21
CFR 1310.09 a temporary exemption from the registration requirement for
persons desiring to engage in activities with any of these three
chemicals, provided that DEA receives a properly completed application
for registration or application for exemption of chemical mixtures on
or before June 9, 2021. The temporary exemption for such persons will
remain in effect until DEA takes final action on their application for
registration or application for exemption of a chemical mixture.
The temporary exemption applies solely to the registration
requirement; all other chemical control requirements, including
recordkeeping and reporting, will become effective on the effective
date of the final rule. Therefore, all transactions of these three
chemicals and chemical mixtures containing any of these three chemicals
will be regulated while an application for registration or exemption is
pending. This is necessary because failing to regulate these
transactions could result in increased diversion of chemicals desirable
to drug traffickers.
Additionally, the temporary exemption does not suspend applicable
federal criminal laws relating to these three chemicals, nor does it
supersede State or local laws or regulations. All handlers of any of
these three chemicals must comply with applicable State and local
requirements in addition to the CSA regulatory controls.
2. Records and Reports. Every DEA registrant must maintain records
and submit reports to DEA with respect to these three chemicals
pursuant to 21 U.S.C. 830(a) and (b)(1) and (2) and in accordance with
21 CFR 1310.04 and 1310.05. Pursuant to 21 CFR 1310.04(a), a record
must be made and maintained for two years after the date of a
transaction involving a listed chemical, provided the transaction is a
regulated transaction.
Each regulated bulk manufacturer of a listed chemical must submit
to DEA manufacturing, inventory, and use data on an annual basis.\10\
Existing standard industry reports containing the required information
are acceptable, provided the information is separate or readily
retrievable from the report.
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\10\ 21 CFR 1310.05(d). See also 21 U.S.C. 830(b)(2).
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The CSA and its implementing regulations require that each
regulated person must report to DEA any regulated transaction involving
an extraordinary quantity of a listed chemical, an uncommon method of
payment or delivery, or any other circumstance that the regulated
person believes may indicate that the listed chemical will be used in
violation of subchapter I of the CSA or 21 CFR part 1310. In addition,
regulated persons must report any proposed regulated transaction with a
person whose description or other identifying characteristics DEA has
previously furnished to the regulated person, any unusual or excessive
loss or disappearance of a listed chemical under the control of the
regulated person, and any in-transit loss in which the regulated person
is the supplier.\11\
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\11\ 21 U.S.C. 830(b)(1)(A)-(C) and 21 CFR 1310.05(a) and
(b)(1).
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3. Importation and Exportation. All importation and exportation of
these three chemicals must be done in compliance with 21 U.S.C. 957,
958, and 971 and in accordance with 21 CFR part 1313.
4. Security. All applicants and registrants must provide effective
controls against theft and diversion in accordance with 21 CFR 1309.71-
1309.73.
5. Administrative Inspection. Places, including factories,
warehouses, or other establishments and conveyances, where registrants
or other regulated persons may lawfully hold, manufacture, distribute,
or otherwise dispose of a list I chemical or where records relating to
those activities are maintained, are controlled premises as defined in
21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for
administrative inspections of these controlled premises as provided in
21 CFR part 1316, subpart A. 21 U.S.C. 880(b).
[[Page 24706]]
6. Liability. Any activity involving these three chemicals not
authorized by, or in violation of, the CSA is unlawful, and may subject
the person to administrative, civil, and/or criminal action.
Regulatory Analyses
Executive Orders 12866 and 13563, Regulatory Planning and Review and
Improving Regulation and Regulatory Review
This rule was developed in accordance with the principles of
Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies to
assess all costs and benefits of available regulatory alternatives and,
if regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health, and safety effects; distributive impacts; and equity).
E.O. 13563 is supplemental to and reaffirms the principles, structures,
and definitions governing regulatory review as established in E.O.
12866.
E.O. 12866 classifies a ``significant regulatory action,''
requiring review by the Office of Management and Budget (OMB), as any
regulatory action that is likely to result in a rule that may: (1) Have
an annual effect on the economy of $100 million or more or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities; (2)
create a serious inconsistency or otherwise interfere with an action
taken or planned by another agency; (3) materially alter the budgetary
impact of entitlements, grants, user fees, or loan programs or the
rights and obligations of recipients thereof; or (4) raise novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the E.O. DEA has determined
that this rule is not a ``significant regulatory action'' under E.O.
12866, section 3(f).
As finalized, PMK glycidate, PMK glycidic acid, and APAA are
subject to all of the regulatory controls and administrative, civil,
and criminal sanctions applicable to the manufacture, distribution,
importing, and exporting of list I chemicals. The first two chemicals,
PMK glycidate and PMK glycidic acid, are closely related in chemical
structure to precursors of MDMA and other ``ecstasy''-type substances,
as discussed in the above background section. APAA is a precursor of
amphetamine and methamphetamine. All three chemicals are highly
suitable for the illicit manufacture of precursors listed in Table I of
the 1988 Convention (3,4-methylenedioxyphenyl-2-propanone (3,4-MDP-2-P)
and 1-phenyl-2-propanone (P-2-P)). As noted earlier, incidents of
illicit manufacture and tracking of these three chemicals have been
reported for many years to the INCB, with an increase in the frequency
and amounts reported in 2018 and 2019.
In making its assessment pursuant to Article 12, paragraph 4 of the
1988 Convention, the CND found that there was no known legitimate
manufacture of and trade in any of the three chemicals and that their
use was limited, in small amounts, to research, development,
laboratory, and analytical purposes. DEA also searched information in
the public domain for legitimate uses of these three chemicals, and
likewise, did not identify any known legitimate use for any of these
chemicals, other than possibly for research purposes. DEA evaluated the
costs and benefits of this action.
DEA cannot rule out the possibility that minimal quantities of PMK
glycidate, PMK glycidic, or APAA are used for the manufacturing of
legitimate pharmaceutical substances. However, DEA did not receive any
public comments to that effect in response to the NPRM.
Costs
As stated above, the only use for PMK glycidate and PMK glycidic
acid is as intermediaries for the manufacturing of MDMA and other
``ecstasy''-type substances. Similarly, the only use for APAA is as a
precursor for amphetamine and methamphetamine. Any manufacturer,
distributor, importer, or exporter of any of these three chemicals for
legitimate pharmaceutical commerce, if they exist at all, will incur
costs if they are not already registered for handling List I chemicals.
The primary costs associated with this rule are the annual registration
fees ($3,047 for manufacturers and $1,523 for distributors, importers,
and exporters). Moreover, any manufacturer that uses any of these three
chemicals for legitimate pharmaceutical purposes is likely to already
be registered with DEA and have all security and other handling
processes in place, resulting in minimal cost.
DEA has identified ten domestic suppliers of one or more of these
chemicals, PMK glycidate, PMK glycidic acid, and APAA; nine of these
suppliers are not currently registered with DEA to handle list I
chemicals. The amount of these three chemicals distributed by these
suppliers is unknown. It is common for chemical distributors to have
items on their catalog while not actually having any material level of
sales. Based on the discussion above, DEA believes any quantity of
sales from these distributors for legitimate pharmaceutical purposes is
minimal. As finalized, suppliers for the legitimate use of PMK
glycidate, PMK glycidic acid, and APAA are expected to choose the
least-cost option, which in many cases may lead them to stop selling
the minimal quantities, if any, of PMK glycidate, PMK glycidic acid,
and APAA, rather than incur the registration cost. Therefore, DEA
estimates that the cost of foregone sales is minimal; and thus, the
cost of this rule is minimal.
This analysis excludes consideration of any economic impact to
those businesses that facilitate the manufacturing and distribution of
PMK glycidate, PMK glycidic acid, or APAA for the illicit production of
amphetamine, methamphetamine, MDMA, or other ``ecstasy''-type
substances.
Benefits
Controlling PMK glycidate, PMK glycidic acid, and APAA is expected
to prevent, curtail, and limit the unlawful manufacture and
distribution of amphetamine, methamphetamine, and MDMA and other
``ecstasy''-type substances. This action is also expected to assist in
the prevention of possible theft or diversion of PMK glycidate, PMK
glycidic acid, and APAA from any legitimate firms. DEA also believes
control is necessary to prevent unscrupulous chemists from synthesizing
PMK glycidate, PMK glycidic acid, and APAA and selling them (as an
unregulated material) through the internet and other channels to
individuals who may wish to acquire unregulated intermediary chemicals
for the purpose of manufacturing illicit amphetamine, methamphetamine,
or MDMA or other ``ecstasy''-type substances.
In summary, DEA conducted a qualitative analysis of costs and
benefits. DEA believes this action will minimize the diversion of PMK
glycidate, PMK glycidic acid, and APAA. DEA believes the legitimate
market for PMK glycidate, PMK glycidic acid, and APAA for legitimate
pharmaceutical purposes is minimal. Thus, any potential cost resulting
from this regulation is minimal.
Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard
[[Page 24707]]
for affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The rule does not have substantial
direct effects on the states, on the relationship between the national
government and the states, or the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
government and Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.
Regulatory Flexibility Act (RFA)
The Acting Administrator, in accordance with the RFA,\12\ has
reviewed this rule, and by approving, it certifies that it will not
have a significant economic impact on a substantial number of small
entities.
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\12\ 5 U.S.C. 601-612.
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As discussed above, PMK glycidate, PMK glycidic acid, and APAA will
now become subject to all of the regulatory controls and
administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, importation, and exportation of list I
chemicals. PMK glycidate and PMK glycidic acid are closely related in
chemical structure to precursors of MDMA and other ``ecstasy''-type
substances. APAA is a precursor of amphetamine and methamphetamine. All
three chemicals are highly suitable for the illicit manufacture of
precursors listed in Table I of the 1988 Convention (3,4-
methylenedioxyphenyl-2-propanone (3,4-MDP-2-P) and 1-phenyl-2-propanone
(P-2-P)). DEA has not identified any legitimate industrial use for PMK
glycidate, PMK glycidic acid, or APAA, other than as intermediary
chemicals in the production of amphetamine, methamphetamine, and MDMA
or other ``ecstasy''-type substances. Therefore, DEA believes the vast
majority, if not all, of PMK glycidate, PMK glycidic acid, and APAA is
used for the illicit manufacturing of amphetamine, methamphetamine, and
MDMA or other ``ecstasy''-type substances. The primary costs associated
with this rule are the annual registration fees ($3,047 for
manufacturers and $1,523 for distributors, importers, and exporters),
but only if they are not already registered to handle any list I
chemicals.
DEA has identified ten domestic suppliers of one or more of the
chemicals, PMK glycidate, PMK glycidic acid, and APAA; nine of these
suppliers are currently not registered with DEA to handle list I
chemicals. All nine non-registered domestic suppliers are affected, and
all nine (94.5 percent, based on Small Business Administration size
standard for chemical distributors and Statistics of U.S. Businesses
data) are estimated to be small entities. The quantity of these three
chemicals distributed by these suppliers is unknown. It is common for
chemical distributors to have items on their catalog while not actually
having any material level of sales. Based on the discussion above, DEA
believes any quantity of sales from these distributors for legitimate
pharmaceutical purposes is minimal. DEA did not receive any comments to
the contrary in response to the NPRM. DEA estimates that this rule will
not have a significant economic impact on a substantial number of small
entities.
Unfunded Mandates Reform Act of 1995 (UMRA)
In accordance with the UMRA, 2 U.S.C. 1501 et seq., DEA has
determined and certifies that this rule will not result in any Federal
mandate that may result ``in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of $100
million or more (adjusted annually for inflation) in any 1 year. . .
.'' Therefore, neither a Small Government Agency Plan nor any other
action is required under the UMRA.
Paperwork Reduction Act
The action does not impose a new collection of information
requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521.
This action will not impose recordkeeping or reporting requirements on
State or local governments, individuals, businesses, or organizations.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
Congressional Review Act
This final rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is
submitting a copy of this final rule to both Houses of Congress and to
the Comptroller General.
List of Subjects 21 CFR Part 1310
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
Accordingly, for the reasons set forth in the preamble, DEA amends
21 CFR part 1310 as follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES
0
1. The authority citation for part 1310 continues to read as follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
0
2. In Sec. 1310.02, add paragraphs (a)(34) through (36) to read as
follows:
Sec. 1310.02 Substances covered.
* * * * *
(a) * * *
(34) 3,4-MDP-2-P methyl glycidate (PMK glycidate) and its optical
and geometric isomers 8535
(35) 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its
salts, optical and geometric isomers, and salts of isomers 8525
(36) Alpha-phenylacetoacetamide (APAA) and its optical isomers 8515
* * * * *
0
3. In Sec. 1310.04:
0
a. Redesignate paragraphs (g)(1)(vii) through (xiii) as paragraphs
(g)(1)(x) through (xvi), respectively;
0
b. Redesignate paragraphs (g)(1)(i) through (vi) as paragraphs
(g)(1)(ii) through (vii), respectively; and
0
c. Add new paragraphs (g)(1)(i), (viii), and (ix).
The additions read as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(g) * * *
(1) * * *
(i) Alpha-phenylacetoacetamide (APAA) and its optical isomers
* * * * *
(viii) 3,4-MDP-2-P methyl glycidate (PMK glycidate) and its optical
and geometric isomers
(ix) 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its
salts, optical and geometric isomers, and salts of isomers
* * * * *
0
4. In Sec. 1310.09, add paragraph (q) to read as follows:
[[Page 24708]]
Sec. 1310.09 Temporary exemption from registration.
* * * * *
(q)(1) Each person required under 21 U.S.C. 822 and 957 to obtain a
registration to manufacture, distribute, import, or export regulated
forms of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P
methyl glycidic acid (PMK glycidic acid), and alpha-
phenylacetoacetamide (APAA), including regulated chemical mixtures
pursuant to Sec. 1310.12, is temporarily exempted from the
registration requirement, provided that DEA receives a properly
completed application for registration or application for exemption for
a chemical mixture containing regulated forms of 3,4-MDP-2-P methyl
glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK
glycidic acid), or alpha-phenylacetoacetamide (APAA) pursuant to Sec.
1310.13 on or before (30 days after publication of a rule implementing
regulations regarding these three chemicals). The exemption will remain
in effect for each person who has made such application until the
Administration has approved or denied that application. This exemption
applies only to registration; all other chemical control requirements
set forth in the Act and parts 1309, 1310, 1313, and 1316 of this
chapter remain in full force and effect.
(2) Any person who manufactures, distributes, imports or exports a
chemical mixture containing regulated forms of 3,4-MDP-2-P methyl
glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK
glycidic acid), or alpha-phenylacetoacetamide (APAA) whose application
for exemption is subsequently denied by DEA must obtain a registration
with DEA. A temporary exemption from the registration requirement will
also be provided for those persons whose applications for exemption are
denied, provided that DEA receives a properly completed application for
registration on or before 30 days following the date of official DEA
notification that the application for exemption has been denied. The
temporary exemption for such persons will remain in effect until DEA
takes final action on their registration application.
0
5. In Sec. 1310.12, in paragraph (c), add in alphanumerical order
entries for 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P
methyl glycidic acid (PMK glycidic acid), and alpha-
phenylacetoacetamide (APAA) in the table ``Table of Concentration
Limits'' to read as follows:
Sec. 1310.12 Exempt chemical mixtures.
* * * * *
(c) * * *
Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
DEA
chemical Concentration Special conditions
code no.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
3,4-MDP-2-P methyl glycidate (PMK 8535 Not exempt at any Chemical mixtures
glycidate) and its optical and geometric concentration. containing any amount of
isomers. this chemical are not
exempt.
3,4-MDP-2-P methyl glycidic acid (PMK 8525 Not exempt at any Chemical mixtures
glycidic acid) and its salts, optical concentration. containing any amount of
and geometric isomers, and salts of this chemical are not
isomers. exempt.
Alpha-phenylacetoacetamide (APAA) and its 8515 Not exempt at any Chemical mixtures
optical isomers. concentration. containing any amount of
this chemical are not
exempt.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-09697 Filed 5-7-21; 8:45 am]
BILLING CODE 4410-09-P
