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

CourtDrug Enforcement Administration,Justice Department
Citation86 FR 24703
Record Number2021-09697
Published date10 May 2021
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
                

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