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
| Citation | 85 FR 82984 |
| Record Number | 2020-26813 |
| Published date | 21 December 2020 |
| Court | Drug Enforcement Administration |
Federal Register, Volume 85 Issue 245 (Monday, December 21, 2020)
[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Proposed Rules]
[Pages 82984-82990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26813]
-----------------------------------------------------------------------
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: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration is proposing 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 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. APAA is used in and is important to the manufacture of the
schedule II controlled substances amphetamine and methamphetamine. If
finalized, this action would subject 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. This action does not propose the
establishment of a threshold for domestic and international
transactions of these chemicals. As such, all transactions involving
any of these chemicals, regardless of size, would be regulated. In
addition, this action proposes that chemical mixtures containing any of
these three chemicals would not be exempt from regulatory requirements
at any concentration. Therefore, all transactions of chemical mixtures
containing any quantity of PMK glycidate, PMK glycidic acid, or APAA
would be regulated.
DATES: Electronic comments must be submitted, and written comments must
be postmarked, on or before February 19, 2021. Commenters should be
aware that the electronic Federal Docket Management System will not
accept 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-542'' on all correspondence, including any
attachments.
Electronic comments: The Drug Enforcement Administration (DEA)
encourages 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 to 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 instantaneously available for public view on http://www.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 the electronic
submission are not necessary and are discouraged. 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 Section, 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 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 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
[[Page 82985]]
all of the personal identifying information you do not want 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
confidential business information to be redacted within the comment.
Comments containing personal identifying information and
confidential business information identified as directed above will
generally be made publicly available in redacted form. If a comment has
so much confidential business information or personal identifying
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 document and supplemental information to
this proposed rule are 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;'' 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.\1\ Pursuant to 28 CFR
0.100(b), the Attorney General has delegated his authority to so
designate list I chemicals to the Administrator of DEA (Administrator).
CSA regulations permit the Administrator to add a substance as a listed
chemical by publishing a final rule in the Federal Register following
the publication of a notice of proposed rulemaking that has provided at
least 30 days for public comments.\2\ The current list of all list I
chemicals is available in 21 CFR 1310.02(a).
---------------------------------------------------------------------------
\1\ 21 U.S.C. 802(34) and 871(b).
\2\ 21 CFR 1310.02(c).
---------------------------------------------------------------------------
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
With the growing problem of illicit drug production, the issue of
precursor chemical control has gained global attention. International
efforts to prevent the illicit production of controlled substances and
international control of precursors have made significant progress with
this problem. Article 12 of the 1988 Convention established
International controls on precursors. This Convention established two
categories of controlled illicit drug precursor substances: Table I and
Table II.\3\ Two international entities have played a crucial role in
this effort: The United Nations Commission on Narcotic Drugs (CND) and
the International Narcotics Control Board (INCB).
---------------------------------------------------------------------------
\3\ Table I and Table II are amended from time to time in
accordance with Article 12 of the 1988 Convention.
---------------------------------------------------------------------------
In response to domestic and international controls on precursors to
the schedule I substance 3,4-methylenedioxymethamphetamine (MDMA), and
schedule II substances amphetamine and methamphetamine, clandestine
laboratory operators have continued to explore alternate methods to
produce these illicit drugs, including the development of their own
immediate precursors (``designer precursors'') and diversion of other
precursors (pre-precursors) to produce these designer precursors. These
clandestine laboratory operators often use 3,4-MDP-2-P methyl glycidate
(PMK glycidate) and 3,4-MDP-2-P methyl glycidic acid (PMK glycidic
acid) as precursors to MDMA, and other ``ecstasy''-type substances, and
alpha-phenylacetoacetamide (APAA) as a precursor to amphetamine and
methamphetamine.
``Precursor chemicals'' are generally defined as chemical
substances that become incorporated, at the molecular level, into a
final product (including a controlled substance); it is a building
block used to manufacture the final product/controlled substance. PMK
glycidate and PMK glycidic acid are building blocks for the manufacture
of the schedule I controlled substance MDMA, while APAA serves as a
building block for the manufacture of the schedule II substance Phenyl-
2-propanone (P2P), and subsequent final manufacture of the schedule II
substances amphetamine and methamphetamine. All these chemicals meet
the definition of list I chemicals since they are important to the
manufacture of these controlled substances.
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 CND
voted to place the chemicals PMK glycidate (and all stereoisomers), PMK
glycidic acid (and all stereoisomers), and 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. As a
Party to the 1988 Convention, the United States is obligated to control
these substances pursuant to Article 12 of the 1988 Convention, as
described in the above Legal Authority section. By designating PMK
glycidate (and its optical and geometric isomers), PMK glycidic acid
(and its salts, optical and geometric isomers, and salts of isomers),
and APAA (and its optical isomers) as list I chemicals, the United
States will fulfill its obligations under the 1988 Convention.\4\
---------------------------------------------------------------------------
\4\ With this scheduling action, if finalized, DEA would control
the same set of chemicals specified by the CND. However, DEA uses
more precise terms that relate to the specific chemical and
variations that can actually exist.
---------------------------------------------------------------------------
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 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 the illicit trafficking and use of these chemicals in
manufacturing controlled substances,
[[Page 82986]]
with increasing frequency and amounts reported in recent years.\5\
---------------------------------------------------------------------------
\5\ 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)
---------------------------------------------------------------------------
In making its assessments 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 substances, and that
their use was limited in small amounts to research, development, and
laboratory analytical purposes. The inclusion of these substances in
Table I would require Governments, as parties to the 1988 Convention,
to establish pre-export notifications as a means of monitoring
shipments entering their territories. Therefore, the CND voted to
include PMK glycidate (all four stereoisomers), PMK glycidic acid (all
four stereoisomers), and APAA (including its optical isomers) in Table
I of the 1988 Convention.
Proposed Designation of PMK Glycidate, PMK Glycidic Acid, and APAA as
List I Chemicals
For the reasons discussed above, the Acting Administrator of DEA
finds that PMK glycidate, PMK glycidic acid, and APAA are used in the
manufacture of a controlled substance in violation of the CSA, and are
important to the manufacture of these controlled substances. Therefore,
the Acting Administrator proposes the designation of PMK glycidate, PMK
glycidic acid, and APAA as list I chemicals.
If finalized, handlers (manufacturers, distributors, importers, and
exporters) of these chemicals would become subject to the chemical
regulatory provisions of the CSA, including 21 CFR parts 1309, 1310,
1313, and 1316. Since even a small amount of these chemicals can
potentially yield a significant amount of controlled substances, this
action does not propose the establishment of a threshold for domestic,
import, or export transactions in accordance with the provisions of 21
CFR 1310.04(g). Rather, DEA is proposing that all transactions,
regardless of size, will be regulated transactions as defined in 21 CFR
1300.02(b). As such, if finalized, all PMK glycidate, PMK glycidic
acid, and APAA transactions will 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 to DEA's Diversion
Control Division, Drug and Chemical Evaluation section on an annual
basis, in accordance with 21 CFR 1310.05(d).
Chemical Mixtures of PMK Glycidate, PMK Glycidic Acid or APAA
This rulemaking also proposes that 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. Therefore, all chemical mixtures containing any quantity of
these three chemicals would be subject to CSA control. This rule
proposes modification of 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.
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.\6\ 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 1310.12(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.
---------------------------------------------------------------------------
\6\ 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 these three chemicals
as list I chemicals will subject 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 publication of a final rule,
persons potentially handling these three chemicals, including regulated
chemical mixtures containing any of these three chemicals, 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, any of
these three chemicals or a chemical mixture containing 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.\7\ 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.\8\
---------------------------------------------------------------------------
\7\ 21 CFR 1309.21.
\8\ 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.\9\
Under DEA implementing regulations, the warehouse in question must
receive the list I chemical from a DEA registrant, shall only
distribute the list I chemical back to the DEA registrant, and
registered location from which it was received.\10\ 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.
---------------------------------------------------------------------------
\9\ 21 U.S.C. 822(c)(2) and 21 U.S.C. 957(b)(1)(B).
\10\ See 21 CFR 1309.23(b)(1).
---------------------------------------------------------------------------
Upon publication of a final rule, any person manufacturing,
distributing, importing, or exporting any of these three chemicals or a
chemical mixture containing 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
[[Page 82987]]
registration and for DEA to immediately issue registrations for those
activities. Therefore, to allow continued legitimate commerce in these
three chemicals, 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 any of these three chemicals,
provided that DEA receives a properly completed application for
registration on or before 30 days after publication of a final rule
implementing regulations regarding these three chemicals. 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, would 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 would be required to
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 is required
to submit manufacturing, inventory, and use data on an annual
basis.\11\ Existing standard industry reports containing the required
information will be acceptable, provided the information is separate or
readily retrievable from the report.
---------------------------------------------------------------------------
\11\ 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.\12\
---------------------------------------------------------------------------
\12\ 21 U.S.C. 830(b) and 21 CFR 1310.05(a) and (b).
---------------------------------------------------------------------------
3. Importation and Exportation. All importation and exportation of
these three chemicals 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 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. 88).
6. Liability. Any activity involving these three chemicals not
authorized by, or in violation of, the CSA would be unlawful, and may
subject the person to administrative, civil, and/or criminal action.
Regulatory Analyses
Executive Orders 12866, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs
This proposed rule was developed in accordance with the principles
of Executive Orders (E.O.) 12866, 13563, and 13771. 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).
E.O. 13771 requires an agency, unless prohibited by law, to
identify at least two existing regulations to be repealed when the
agency publicly proposes for notice and comment or otherwise
promulgates a new regulation.\13\ In furtherance of this requirement,
E.O. 13771 requires that the new incremental costs associated with new
regulations, to the extent permitted by law, be offset by the
elimination of existing costs associated with at least two prior
regulations.\14\ According to guidance provided by OMB, the
requirements of E.O. 13771 only apply to each new ``significant
regulatory action that . . . imposes costs.'' \15\ This proposed rule
is not expected to be an E.O. 13771 regulatory action because this
proposed rule is not significant under E.O. 12866.
---------------------------------------------------------------------------
\13\ Sec. 2(a).
\14\ Sec. 2(c).
\15\ OMB Guidance Implementing Executive Order 13771 titled
``Reducing Regulation and Controlling Regulatory Costs'' (April 5,
2017).
---------------------------------------------------------------------------
If finalized as proposed, PMK glycidate, PMK glycidic acid, and
APAA will 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. 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
[[Page 82988]]
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 recent years.
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 proposed 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. DEA welcomes any public comment
on these quantities and their economic significance.
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, would incur
costs if this proposed rule were finalized. The primary costs
associated with this proposed rule are the annual registration fees
($3,047 for manufacturers and $1,523 for distributors, importers, and
exporters). Additionally, 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. If this proposed rule is finalized, suppliers for the
legitimate use of PMK glycidate, PMK glycidic acid, and APAA are
expected to choose the least-cost option, and 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
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 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 it (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 proposed action, if finalized, will
minimize the diversion of PMK glycidate, PMK glycidic acid, and APAA.
DEA believes the market for PMK glycidate, PMK glycidic acid, and APAA
for the legitimate pharmaceutical purposes is minimal. Thus, any
potential cost resulting from this regulation is minimal. Therefore,
the estimated economic impact of this proposed rule is less than $100
million in any given year.
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 (RFA)
The Acting Administrator, in accordance with the RFA,\16\ 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, PMK
glycidate, PMK glycidic acid, and APAA will 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. 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
[[Page 82989]]
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 proposed rule are the annual registration fees ($3,047 for
manufacturers and $1,523 for distributors, importers, and exporters).
Additionally, any manufacturer that uses PMK glycidate, PMK glycidic
acid, or APAA for legitimate pharmaceutical purposes is likely to be
already registered with DEA and have all security and other handling
processes in place, resulting in minimal cost.
---------------------------------------------------------------------------
\16\ 5 U.S.C. 601-612.
---------------------------------------------------------------------------
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 estimates that this proposed
rule, if promulgated, will not have a significant economic impact on a
substantial number of small entities. DEA welcomes any public comment
regarding this estimate.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA), 2
U.S.C. 1501 et seq., DEA has determined and certifies that this
proposed rule 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 the
UMRA.
Paperwork Reduction Act
The 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 21 CFR Part 1310
Drug traffic control, Exports, Imports, Reporting and recordkeeping
requirements.
Accordingly, for the reasons set forth in the preamble, DEA
proposes to amend 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. Amend Sec. 1310.09 by adding paragraph (q) to read as follows:
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 glycidate (PMK glycidate), 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. Amend Sec. 1310.12(c) by adding in alphabetical order entries for
3,4-MDP-
[[Page 82990]]
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.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-26813 Filed 12-18-20; 8:45 am]
BILLING CODE 4410-09-P
