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

CourtDrug Enforcement Administration
Citation86 FR 16558
Record Number2021-05346
Publication Date30 March 2021
Federal Register, Volume 86 Issue 59 (Tuesday, March 30, 2021)
[Federal Register Volume 86, Number 59 (Tuesday, March 30, 2021)]
                [Proposed Rules]
                [Pages 16558-16565]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2021-05346]
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                DEPARTMENT OF JUSTICE
                Drug Enforcement Administration
                21 CFR Part 1310
                [Docket No. DEA-678]
                Designation of Methyl alpha-phenylacetoacetate, a Precursor
                Chemical Used in the Illicit Manufacture of Phenylacetone,
                Methamphetamine, and Amphetamine, as a List I Chemical
                AGENCY: Drug Enforcement Administration, Department of Justice.
                ACTION: Notice of proposed rulemaking.
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                SUMMARY: The Drug Enforcement Administration is proposing the control
                of the chemical methyl alpha-phenylacetoacetate (also known as MAPA;
                methyl 3-oxo-2-phenylbutanoate; methyl 2-phenylacetoacetate; [alpha]-
                acetyl-benzeneacetic acid, methyl ester; and CAS Number: 16648-44-5)
                and its optical isomers as a list I chemical under the Controlled
                Substances Act (CSA). Methyl alpha-phenylacetoacetate is used in
                clandestine laboratories to illicitly manufacture the schedule II
                controlled substances phenylacetone (also known as phenyl-2-propanone
                or P2P), methamphetamine, and amphetamine and is important to the
                manufacture of these controlled substances. If finalized, this action
                would subject handlers of methyl alpha-phenylacetoacetate to the
                chemical regulatory provisions of the CSA and its implementing
                regulations. This rulemaking does not establish a threshold for
                domestic and international transactions of methyl alpha-
                phenylacetoacetate. As such, all transactions of chemical mixtures
                containing methyl alpha-phenylacetoacetate would be regulated at any
                concentration and would be subject to control under the CSA.
                DATES: Comments must be submitted electronically or postmarked on or
                before June 1, 2021. Commenters should be aware that the electronic
                Federal Docket Management System will not accept any comments after
                11:59 p.m. Eastern Time on the last day of the comment period.
                ADDRESSES: To ensure proper handling of comments, please reference
                ``Docket No. DEA-678'' on all electronic and written correspondence,
                including any attachments.
                 Electronic comments: The Drug Enforcement Administration
                (DEA) encourages that all comments be submitted electronically through
                the Federal eRulemaking Portal which provides the ability to type short
                comments directly into the comment field on the web page or attach a
                file for lengthier comments. Please go to http://www.regulations.gov
                and follow the online instructions at that site for submitting
                comments. Upon completion of your submission, you will receive a
                Comment Tracking Number for your comment. Please be aware that
                submitted comments are not
                [[Page 16559]]
                instantaneously available for public view on Regulations.gov. If you
                have received a Comment Tracking Number, your comment has been
                successfully submitted and there is no need to resubmit the same
                comment.
                 Paper comments: Paper comments that duplicate electronic
                submissions are not necessary. Should you wish to mail a paper comment,
                in lieu of an electronic comment, it should be sent via regular or
                express mail to: Drug Enforcement Administration, Attn: DEA Federal
                Register Representative/DPW, 8701 Morrissette Drive, Springfield,
                Virginia 22152.
                FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
                Evaluation, Diversion Control Division, Drug Enforcement
                Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
                Virginia 22152; Telephone: (571) 362-3249.
                SUPPLEMENTARY INFORMATION:
                Posting of Public Comments
                 Please note that all comments received in response to this docket
                are considered part of the public record. They will, unless reasonable
                cause is given, be made available by the Drug Enforcement
                Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying
                information (such as your name, address, etc.) voluntarily submitted by
                the commenter. The Freedom of Information Act applies to all comments
                received. If you want to submit personal identifying information (such
                as your name, address, etc.) as part of your comment, but do not want
                it to be made publicly available, you must include the phrase
                ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your
                comment. You must also place all of the personal identifying
                information you do not want made publicly available in the first
                paragraph of your comment and identify what information you want
                redacted.
                 If you want to submit confidential business information as part of
                your comment, but do not want it to be made publicly available, you
                must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
                first paragraph of your comment. You must also prominently identify the
                confidential business information to be redacted within the comment.
                 Comments containing personal identifying information or
                confidential business information identified as directed above will be
                made publicly available in redacted form. If a comment has so much
                confidential business information that it cannot be effectively
                redacted, all or part of that comment may not be made publicly
                available. Comments posted to http://www.regulations.gov may include
                any personal identifying information (such as name, address, and phone
                number) included in the text of your electronic submission that is not
                identified as directed above as confidential.
                 An electronic copy of this proposed rule is available at http://www.regulations.gov for easy reference.
                Legal Authority
                 The Controlled Substances Act (CSA) gives the Attorney General the
                authority to specify, by regulation, a chemical as a list I chemical.
                21 U.S.C. 802(34). The term ``list I chemical'' means a chemical that
                is used in manufacturing a controlled substance in violation of the CSA
                and is important to the manufacture of the controlled substance. Id.
                Pursuant to 28 CFR 0.100(b), the Attorney General has delegated his
                authority to designate list I chemicals to the Administrator of DEA
                (Administrator).
                 The DEA regulations set forth the process by which DEA may add a
                chemical as a listed chemical. As set forth in 21 CFR 1310.02(c), the
                agency may do so by publishing a final rule in the Federal Register
                following a published notice of proposed rulemaking with at least 30
                days for public comments. The current list of all list I chemicals is
                available in 21 CFR 1310.02(a).
                 In addition, the United States is a party to the 1988 United
                Nations Convention against Illicit Traffic in Narcotic Drugs and
                Psychotropic Substances (1988 Convention), December 20, 1988, 1582
                U.N.T.S. 95. Under Article 12 of the 1988 Convention, when the United
                States receives notification that a chemical has been added to Table I
                or Table II of the 1988 Convention, the United States is required to
                take measures it deems appropriate to monitor the manufacture and
                distribution of that chemical within the United States and to prevent
                its diversion. The 1988 Convention also requires the United States to
                take other specified measures related to that chemical, including
                measures related to its international trade.
                Background
                 By letter dated May 7, 2020, in accordance with Article 12,
                paragraph 6 of the 1988 Convention, the Secretary-General of the United
                Nations informed the United States Government that the chemical methyl
                alpha-phenylacetoacetate (MAPA), including its optical isomers, was
                added to Table I of the 1988 Convention. This letter was prompted by a
                March 4, 2020, decision at the 63rd Session of the United Nations
                Commission on Narcotic Drugs (CND) to add MAPA to Table I. As discussed
                above, the United States is a party to the 1988 Convention, and has
                certain obligations pursuant to Article 12. By designating MAPA as a
                list I chemical, the United States will fulfill its obligations under
                the 1988 Convention.
                 MAPA is used in, and is important to, the manufacture of the
                schedule II substances phenylacetone (also known as phenyl-2-propanone,
                P2P, or benzyl methyl ketone), methamphetamine, and amphetamine.
                Throughout the 1970s, methamphetamine was illicitly produced in the
                United States, primarily with the precursor chemical P2P. In response
                to the illicit use of P2P, DEA controlled P2P as a schedule II
                controlled substance in 1980 pursuant to the ``immediate precursor''
                provisions of the CSA, specifically 21 U.S.C. 811(e).\1\ Clandestine
                laboratory operators have circumvented this control by developing a
                variety of synthetic methods for producing P2P.
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                 \1\ 44 FR 7182 (Feb. 11, 1980).
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                 Congress and DEA responded by placing controls on precursor
                chemicals used in the illicit production of P2P, such as phenylacetic
                acid (and its salts and esters), acetic anhydride, benzyl cyanide,
                benzaldehyde, and nitroethane.2 3 However, clandestine
                laboratory operators circumvented these controls by using alternative
                precursors that avoid the production of P2P: Ephedrine and
                pseudoephedrine for the production of methamphetamine; and
                phenylpropanolamine for the production of amphetamine. This led
                Congress and DEA to place stringent controls on the manufacture,
                distribution, importation, and exportation of ephedrine (its salts,
                optical isomers, and salts of optical isomers), pseudoephedrine, and
                phenylpropanolamine (controlled as list I chemicals), and
                pharmaceutical products containing these chemicals through the Combat
                Methamphetamine Epidemic Act of 2005 (Title VII of the USA PATRIOT Act
                Improvement and Reauthorization Act of 2005, Pub. L. 109-117), the
                Methamphetamine Production Prevention Act of 2008 (Pub.
                [[Page 16560]]
                L. 110-415), and the Combat Methamphetamine Act of 2010 (Pub. L. 111-
                268).\4\ The international community soon took similar measures.
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                 \2\ On November 18, 1988, the Chemical Diversion and Trafficking
                Act (Subtitle A of Title VI of Pub. L. 100-690) was enacted.
                 \3\ Under 21 CFR 1310.02(a), benzaldehyde, benzyl cyanide,
                nitroethane, and phenylacetic acid (including its salts and esters)
                are list I chemicals. Under 21 CFR 1310.02(b), acetic anhydride is a
                list II chemical.
                 \4\ DEA implemented the Combat Methamphetamine Epidemic Act of
                2005, the Methamphetamine Production Prevention Act of 2008, and the
                Combat Methamphetamine Enhancement Act of 2010 in a series of
                interim and final rules. 72 FR 17401 (Apr. 9, 2007), 72 FR 28601
                (May 22, 2007), 73 FR 73549 (Dec. 3, 2008), 73 FR 79318 (Dec. 29,
                2008), 75 FR 4973 (Feb. 1, 2010), 75 FR 10168 (Mar. 5, 2010), 75 FR
                38915 (Jul. 7, 2010), 76 FR 20518 (Apr. 13, 2011), and 76 FR 74696
                (Dec. 1, 2011).
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                 With the growing problem of illicit drug production, the issue of
                precursor chemical control has gained global attention. International
                controls on precursors were first established under Article 12 of the
                1988 Convention, which established two categories of controlled illicit
                drug precursor substances: Table I and Table II.\5\ International
                efforts to prevent the illicit production of amphetamine-type
                stimulants (including amphetamine and methamphetamine), and
                international control of precursors, have since made significant
                progress. Two international entities have played a crucial role in this
                effort: The CND and the International Narcotics Control Board (INCB).
                The CND meets annually to consider and adopt a range of decisions and
                resolutions related to international drug control treaties, including
                the 1988 Convention. The INCB is an independent, quasi-judicial expert
                body for the implementation of the international drug control treaties,
                including the 1988 Convention.
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                 \5\ Table I and Table II are annexed to the Convention.
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                 In response to domestic and international controls on amphetamine
                and methamphetamine precursors, clandestine laboratory operators have
                continued to explore alternate methods of making these illicit drugs,
                including developing techniques to manufacture their own precursors and
                diverting other precursors to produce these precursors. The INCB
                reported the emergence of MAPA in late 2017, noting its use as a
                precursor for the production of P2P.\6\ The emergence and increase in
                encounters of MAPA are linked to increased scrutiny over other P2P
                precursors, such as alpha-phenylacetoacetamide (APAA).\7\ Although MAPA
                does not have any legitimate use and it has not been widely traded
                through legitimate channels, it is advertised by online suppliers.\8\
                Clandestine laboratory operators currently use MAPA to manufacture P2P,
                which they then convert to methamphetamine and amphetamine.
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                 \6\ Statement by Mr. Cornelis de Joncheere, President,
                International Narcotics Control Board, Reconvened sixty-second
                session of the Commission on Narcotic Drugs, 13 December 2019, at 1.
                 \7\ Id.
                 \8\ Id.
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                MAPA
                 MAPA is known as methyl alpha-phenylacetoacetate; methyl 3-oxo-2-
                phenylbutanoate; methyl 2-phenylacetoacetate; [alpha]-acetyl-
                benzeneacetic acid, methyl ester; and CAS Number: 16648-44-5. MAPA
                first emerged in late 2017 with the Netherlands reporting seizures
                totaling nearly 490 kg on Form D.\9\ Belgium followed in 2018 with
                reports through the Precursors Incident Communication System (PICS) of
                more than 550 kg of MAPA seized.\10\ China was reported as the alleged
                origin for all of the incidents in the Netherlands or Belgium where the
                origin was provided. The INCB reported an increase in the frequency of
                seizures and amounts seized reported through PICS since November
                2018.\11\
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                 \9\ Member countries use Form D to report to INCB annual
                information on substances frequently used in the illicit manufacture
                of narcotic drugs and psychotropic substances.
                 \10\ The Precursors Incident Communication System or PICS is a
                worldwide, real-time, on-line tool for communication and information
                sharing between national authorities on precursor incidents to
                include seizures, stopped shipments, diversion and diversion
                attempts, illicit laboratories and associated equipment.
                 \11\ Id.
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                 MAPA is a close chemical relative of precursors controlled under
                the 1988 Convention (e.g., APAAN and APAA) and the timing of its
                emergence suggests it is trafficked to circumvent these recent
                precursor controls. The INCB notes that MAPA does not have any
                legitimate use.\12\ DEA has not identified any known legitimate use for
                MAPA, other than in small amounts for research, development, and
                laboratory analytical purposes. Due to the lack of industrial uses of
                MAPA, the chemical has not been widely available from legitimate
                chemical suppliers. Since late 2017, however, there have been large
                international seizures of MAPA, primarily in Europe, which suggest
                there is a ready supply of MAPA from international chemical
                manufacturers. The only use for a large quantity of MAPA of which DEA
                is aware is as a primary precursor for conversion to P2P, and
                subsequent conversion to amphetamine or methamphetamine.
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                 \12\ Id.
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                 Between late 2017, and May 7, 2019, the INCB noted 29 incidents
                from PICS where MAPA was seized. The amount of MAPA seized in
                individual incidents ranged from 500 grams to 2 metric tons, and
                totaled more than 10.5 metric tons. All incidents reported in PICS
                occurred in Europe, or involved shipments of MAPA destined for
                countries in Europe.
                 DEA has determined that MAPA is now readily available from
                commercial chemical suppliers and has identified seven potential
                suppliers in China, five potential suppliers in the United States,
                three potential suppliers in the United Kingdom, and one potential
                supplier each in France, Hong Kong, and Latvia.
                 DEA is concerned about the ease with which MAPA serves as a
                precursor chemical for illicit controlled substance production and with
                the international trafficking in this chemical. The international
                community shares this concern. The INCB found ``that MAPA is frequently
                used in the illicit manufacture of amphetamine-type stimulants, namely
                amphetamine, and that the volume and extent of the illicit manufacture
                of amphetamine-type stimulants pose serious public health or social
                problems so as to warrant international action.'' \13\ Based in part on
                the findings of the INCB, and as noted above, the CND has added MAPA to
                Table I of the 1988 Convention. Therefore, DEA is proposing the
                designation of MAPA as a list I chemical.
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                 \13\ Notification from the President of the INCB to the Chair of
                the CND on its sixty-third session concerning the scheduling of MAPA
                under the 1988 Convention, Nov. 12, 2019, at 1.
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                Proposed Designation of MAPA and Its Optical Isomers as a List I
                Chemical
                 For the reasons discussed above, the Acting Administrator of DEA
                finds that MAPA is used in the manufacture of controlled substances
                (i.e., schedule II substances P2P, methamphetamine, and amphetamine) in
                violation of the CSA and is important to the manufacture of these
                controlled substances. Laboratory operators are using MAPA as the
                precursor material for the illicit manufacture of P2P, methamphetamine,
                and amphetamine. Therefore, the Acting Administrator proposes the
                designation of MAPA as a list I chemical.
                 If finalized, handlers of MAPA would become subject to the chemical
                regulatory provisions of the CSA, including 21 CFR parts 1309, 1310,
                1313, and 1316. Since 1 gram of MAPA could make approximately 1 gram of
                methamphetamine hydrochloride, which is equivalent to approximately 200
                tablets containing 5 milligrams of methamphetamine hydrochloride, this
                action does not propose the establishment of a threshold for domestic
                and import transactions of MAPA in accordance with the
                [[Page 16561]]
                provisions of 21 CFR 1310.04(g). Therefore, DEA is proposing that all
                MAPA transactions, regardless of size, would be regulated transactions
                as defined in 21 CFR 1300.02(b). As such, if finalized, all MAPA
                transactions would be subject to recordkeeping, reporting, import and
                export controls, and other CSA chemical regulatory requirements. In
                addition, each regulated bulk manufacturer must submit manufacturing,
                inventory, and use data on an annual basis, in accordance with 21 CFR
                1310.05(d).
                Chemical Mixtures of MAPA
                 This rulemaking also proposes that chemical mixtures containing
                MAPA would not be exempt from regulatory requirements at any
                concentration, unless a manufacturer submits to DEA an application for
                exemption of such chemical mixture, DEA accepts the application for
                filing, and DEA exempts the chemical mixture in accordance with 21 CFR
                1310.13 (Exemption of chemical mixtures by application). Since 1 gram
                of MAPA could make approximately 1 gram of methamphetamine
                hydrochloride, which is equivalent to approximately 200 tablets
                containing 5 milligrams of methamphetamine hydrochloride, regulation of
                chemical mixtures containing any amount of MAPA is necessary to prevent
                the illicit extraction, isolation, and use of MAPA. Therefore, all
                chemical mixtures containing any quantity of MAPA would be subject to
                control under the CSA, unless a manufacturer of MAPA is granted an
                exemption by the application process in accordance with 21 CFR 1310.13.
                This rulemaking proposes the modification of the ``Table of
                Concentration Limits'' in 21 CFR 1310.12(c) to reflect the fact that
                chemical mixtures containing any amount of MAPA are subject to CSA
                chemical control provisions.
                Application Process for Exemption of Chemical Mixtures
                 DEA has implemented an application process to exempt certain
                chemical mixtures from the requirements of the CSA and its implementing
                regulations.\14\ Manufacturers may submit an application for exemption
                for those mixtures that do not meet the criteria set forth in 21 CFR
                1310.12(d) for an automatic exemption. Pursuant to 21 CFR 1310.13(a),
                DEA may grant an exemption of a chemical mixture, by publishing a final
                rule in the Federal Register, if DEA determines that: (1) The mixture
                is formulated in such a way that it cannot be easily used in the
                illicit production of a controlled substance, and (2) the listed
                chemical or chemicals cannot be readily recovered.
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                 \14\ 21 CFR 1310.13 specifies that this chemical mixture is a
                chemical mixture consisting of two or more chemical components, at
                least one of which is a list I or list II chemical.
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                Requirements for Handling List I Chemicals
                 If finalized as proposed, the designation of MAPA as a list I
                chemical would subject handlers (manufacturers, distributors,
                importers, and exporters) and proposed handlers to all of the
                regulatory controls and administrative, civil, and criminal sanctions
                applicable to the manufacture, distribution, importing, and exporting
                of a list I chemical. Upon publication of a final rule, persons
                potentially handling MAPA, including regulated chemical mixtures
                containing MAPA, would be required to comply with the following list I
                chemical regulations:
                 1. Registration. Any person who handles (manufactures, distributes,
                imports, or exports), or proposes to engage in such handling of, MAPA
                or a chemical mixture containing MAPA must obtain a registration
                pursuant to 21 U.S.C. 822, 823, 957, and 958. Regulations describing
                registration for list I chemical handlers are set forth in 21 CFR part
                1309. DEA regulations require separate registrations for manufacturing,
                distributing, importing, and exporting of MAPA.\15\ Further, a separate
                registration is required for each principal place of business at one
                general physical location where list I chemicals are manufactured,
                distributed, imported, or exported by a person.\16\
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                 \15\ 21 CFR 1309.21.
                 \16\ 21 CFR 1309.23(a). See also 21 U.S.C. 822(e)(1) with
                separate registration requirements pertaining to manufacturing or
                distributing a list I chemical.
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                 DEA notes that under the CSA, ``warehousemen'' are not required to
                register and may lawfully possess list I chemicals, if the possession
                of those chemicals is in the usual course of business or
                employment.\17\ Under DEA implementing regulations, the warehouse in
                question must receive the list I chemical from a DEA registrant and
                shall only distribute the list I chemical back to the DEA registrant
                and registered location from which it was received.\18\ A warehouse
                that distributes list I chemicals to persons other than the registrant
                and registered location from which they were obtained is conducting
                distribution activities and is required to register as such.
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                 \17\ 21 U.S.C. 822(c)(2) and 21 U.S.C. 957(b)(1)(B).
                 \18\ See 21 CFR 1309.23(b)(1).
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                 Upon publication of a final rule, any person manufacturing,
                distributing, importing, or exporting MAPA or a chemical mixture
                containing MAPA would become subject to the registration requirement
                under the CSA. DEA recognizes, however, that it is not possible for
                persons who are subject to the registration requirements to immediately
                complete and submit an application for registration and for DEA to
                immediately issue registrations for those activities. Therefore, to
                allow any continued legitimate commerce in MAPA, DEA is proposing to
                establish in 21 CFR 1310.09 a temporary exemption from the registration
                requirement for persons desiring to engage in activities with MAPA,
                provided that DEA receives a properly completed application for
                registration on or before 30 days after publication of a final rule
                implementing regulations regarding MAPA. The temporary exemption for
                such persons would remain in effect until DEA takes final action on
                their application for registration or application for exemption of a
                chemical mixture.
                 The temporary exemption would apply solely to the registration
                requirement; all other chemical control requirements, including
                recordkeeping and reporting, would become effective on the effective
                date of the final rule. Therefore, all transactions of MAPA and
                chemical mixtures containing MAPA would be regulated while an
                application for registration or exemption is pending. This is necessary
                because a delay in regulating these transactions could result in
                increased diversion of chemicals desirable to drug traffickers.
                 Additionally, the temporary exemption for registration does not
                suspend applicable Federal criminal laws relating to MAPA, nor does it
                supersede State or local laws or regulations. All handlers of MAPA must
                comply with applicable State and local requirements in addition to the
                CSA regulatory controls.
                 2. Records and Reports. Every DEA registrant would be required to
                maintain records and submit reports to DEA with respect to MAPA
                pursuant to 21 U.S.C. 830(a) and (b)(1) and (2) and in accordance with
                21 CFR 1310.04 and 1310.05. Pursuant to 21 CFR 1310.04, a record must
                be made and maintained for two years after the date of a transaction
                involving a listed chemical, provided the transaction is a regulated
                transaction.
                 Each regulated bulk manufacturer of a listed chemical would be
                required to submit manufacturing, inventory, and
                [[Page 16562]]
                use data on an annual basis.\19\ Existing standard industry reports
                containing the required information would be acceptable, provided the
                information is separate or readily retrievable from the report.
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                 \19\ 21 CFR 1310.05(d).
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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. In addition, regulated persons
                must report any proposed regulated transaction with a person whose
                description or other identifying characteristics DEA has previously
                furnished to the regulated person, any unusual or excessive loss or
                disappearance of a listed chemical under the control of the regulated
                person, and any in-transit loss in which the regulated person is the
                supplier.\20\
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                 \20\ 21 U.S.C. 830(b) and 21 CFR 1310.05(a) and (b).
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                 3. Importation and Exportation. All importation and exportation of
                MAPA would need to be in compliance with 21 U.S.C. 957, 958, and 971
                and in accordance with 21 CFR part 1313.
                 4. Security. All applicants and registrants would be required to
                provide effective controls against theft and diversion of list I
                chemicals in accordance with 21 CFR 1309.71-1309.73.
                 5. Administrative Inspection. Places, including factories,
                warehouses, or other establishments and conveyances, where registrants
                or other regulated persons may lawfully hold, manufacture, distribute,
                or otherwise dispose of a list I chemical or where records relating to
                those activities are maintained, are controlled premises as defined in
                21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for
                administrative inspections of these controlled premises as provided in
                21 CFR part 1316, subpart A.\21\
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                 \21\ 21 U.S.C. 880.
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                 6. Liability. Any activity involving MAPA not authorized by, or in
                violation of, the CSA would be unlawful, and would subject the person
                to administrative, civil, and/or criminal action.
                Regulatory Analyses
                Executive Orders 12866 (Regulatory Planning and Review) and 13563
                (Improving Regulation and Regulatory Review)
                 This proposed rule was developed in accordance with the principles
                of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies
                to assess all costs and benefits of available regulatory alternatives
                and, if regulation is necessary, to select regulatory approaches that
                maximize net benefits (including potential economic, environmental,
                public health, and safety effects; distributive impacts; and equity).
                E.O. 13563 is supplemental to and reaffirms the principles, structures,
                and definitions governing regulatory review as established in E.O.
                12866. E.O. 12866 classifies a ``significant regulatory action,''
                requiring review by the Office of Management and Budget (OMB) as any
                regulatory action that is likely to result in a rule that may: (1) Have
                an annual effect on the economy of $100 million or more or adversely
                affect in a material way the economy, a sector of the economy,
                productivity, competition, jobs, the environment, public health or
                safety, or State, local, or tribal governments or communities; (2)
                create a serious inconsistency or otherwise interfere with an action
                taken or planned by another agency; (3) materially alter the budgetary
                impact of entitlements, grants, user fees, or loan programs or the
                rights and obligations of recipients thereof; or (4) raise novel legal
                or policy issues arising out of legal mandates, the President's
                priorities, or the principles set forth in the E.O. DEA has determined
                that this proposed rule is not a ``significant regulatory action''
                under E.O. 12866, section 3(f).
                 If finalized as proposed, MAPA would be subject to all of the
                regulatory controls and administrative, civil, and criminal sanctions
                applicable to the manufacture, distribution, importing, and exporting
                of list I chemicals. MAPA is used in, and is important to, the illicit
                manufacture of the schedule II-controlled substances P2P,
                methamphetamine, and amphetamine.
                 DEA has searched information in the public domain for any
                legitimate uses of this chemical. Other than the small amounts for
                research, development, and laboratory analytical purposes, DEA has not
                documented any industrial use for MAPA except for it being a chemical
                intermediate in the production of the schedule II substances P2P,
                methamphetamine, and amphetamine. Based on the review of established
                aggregate production quota for P2P (40 grams for 2019), legal
                conversion of MAPA to P2P in the United States, if it takes place at
                all, is limited to small, gram quantities. Therefore, DEA concludes the
                vast majority of, if not all, MAPA is used for the manufacturing of
                illicit P2P, methamphetamine, and amphetamine.
                 DEA cannot rule out the possibility that minimal quantities of MAPA
                are used for the manufacturing of legitimate P2P. However, if there are
                any quantities of MAPA used for the manufacturing of legitimate P2P,
                the quantities are believed to be minimal. DEA welcomes any public
                comment on these quantities and their economic significance.
                 DEA evaluated the costs and benefits of this proposed action.
                Costs
                 DEA believes the market for MAPA for the legitimate manufacturing
                of pharmaceutical amphetamine or methamphetamine is minimal. As stated
                above, the only use for MAPA of which DEA is aware is as a chemical
                intermediate for the manufacture of P2P, methamphetamine, and
                amphetamine. Any manufacturer, distributor, importer, or exporter of
                MAPA for the production of legitimate P2P, methamphetamine, and
                amphetamine, if they exist at all, would incur costs if this proposed
                rule were finalized. The primary costs associated with this proposed
                rule would be the annual registration fees for manufacturers ($3,699)
                and for distributors, importers, and exporters ($1,850). However, any
                manufacturer that uses MAPA for legitimate P2P, methamphetamine, and
                amphetamine production would already be registered with DEA and have
                all security and other handling processes established because of the
                controls already in place on P2P, methamphetamine, and amphetamine,
                resulting in minimal cost to those entities. As there are different
                forms of handling the scheduled substances versus the list I chemical
                (distribution of P2P, methamphetamine, and amphetamine versus exporting
                MAPA), this could require a separate registration for the different
                handling of the substances. If an entity is already registered to
                handle, manufacture, import, or export a scheduled substance, the
                entity would not need an additional registration for the list I
                chemical, provided it is handling the list I chemical in the same
                manner that it is registered for with the scheduled substance, or as a
                coincident activity permitted by Sec. 1309.21. Even with the
                possibility of these additional registrations, DEA believes that the
                cost would be minimal.
                [[Page 16563]]
                 DEA has identified five domestic suppliers of MAPA, only one of
                which is registered with DEA to handle list I chemicals. It is
                difficult to estimate the quantity of MAPA these suppliers distribute.
                Chemical distributors often have items in their catalog while not
                actually having any material level of sales. If this proposed rule is
                finalized, suppliers for the legitimate use of MAPA, if any, are
                expected to choose the least-cost option, and stop selling the minimal
                quantities of MAPA, rather than incur the registration cost. Because
                DEA believes the quantities of MAPA supplied for the legitimate
                manufacturing of P2P, methamphetamine, and amphetamine are minimal, DEA
                estimates that the cost of foregone sales is minimal; and thus, the
                cost of this proposed rule is minimal. DEA welcomes any public comment
                regarding this estimate.
                 This analysis excludes consideration of any economic impact to
                those businesses that facilitate the manufacture and distribution of
                MAPA for the production of manufacturing illicit P2P, methamphetamine,
                and amphetamine. As a law enforcement organization and as a matter of
                principle, DEA believes considering the economic utility of
                facilitating the manufacture of illicit P2P, methamphetamine, and
                amphetamine would be improper.
                Benefits
                 Controlling MAPA is expected to prevent, curtail, and limit the
                unlawful manufacture and distribution of the controlled substances P2P,
                methamphetamine, and amphetamine. As a list I chemical, handling of
                MAPA would require registration with DEA, various controls, and
                monitoring as required by the CSA. This proposed rule is also expected
                to assist in preventing the possible theft or diversion of MAPA from
                any legitimate firms. DEA also believes control is necessary to prevent
                unscrupulous chemists from synthesizing MAPA and selling it (as an
                unregulated material) through the internet and other channels, to
                individuals who may wish to acquire an unregulated chemical
                intermediate for the purpose of manufacturing illicit P2P,
                methamphetamine, and amphetamine.
                 In summary, DEA conducted a qualitative analysis of costs and
                benefits. DEA believes this proposed action, if finalized, will
                minimize the diversion of MAPA. DEA believes the market for MAPA for
                the legitimate manufacturing of P2P, methamphetamine, and amphetamine
                is minimal. Therefore, any potential cost as a result of this
                regulation is minimal.
                Executive Order 12988, Civil Justice Reform
                 This proposed regulation meets the applicable standards set forth
                in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
                and ambiguity, minimize litigation, provide a clear legal standard for
                affected conduct, and promote simplification and burden reduction.
                Executive Order 13132, Federalism
                 This proposed rulemaking does not have federalism implications
                warranting the application of E.O. 13132. The proposed rule does not
                have substantial direct effects on the States, on the relationship
                between the national government and the States, or the distribution of
                power and responsibilities among the various levels of government.
                Executive Order 13175, Consultation and Coordination With Indian Tribal
                Governments
                 This proposed rule does not have tribal implications warranting the
                application of E.O. 13175. It does not have substantial direct effects
                on one or more Indian tribes, on the relationship between the Federal
                Government and Indian tribes, or on the distribution of power and
                responsibilities between the Federal Government and Indian tribes.
                Regulatory Flexibility Act
                 The Acting Administrator, in accordance with the Regulatory
                Flexibility Act (RFA),\22\ has reviewed this proposed rule and by
                approving it certifies that it will not have a significant economic
                impact on a substantial number of small entities. As discussed above,
                if finalized as proposed, MAPA would be subject to all of the
                regulatory controls and administrative, civil, and criminal sanctions
                applicable to the manufacture, distribution, importation, and
                exportation of list I chemicals. MAPA is used in, and is important to,
                the illicit manufacture of the schedule II-controlled substances P2P,
                methamphetamine, and amphetamine. DEA has not identified any legitimate
                industrial use for MAPA, other than its role as a chemical intermediate
                in the production of P2P, methamphetamine, and amphetamine. Based on
                the review of established aggregate production quota for P2P, 40 grams
                for 2019, legal conversion of MAPA to P2P in the United States, if it
                takes place at all, is limited to small, gram quantities. Therefore,
                DEA believes the vast majority, if not all, of MAPA is used for the
                illicit manufacturing of P2P, methamphetamine, and amphetamine. The
                primary costs associated with this proposed rule are the annual
                registration fees ($3,699 for manufacturers and $1,850 for
                distributors, importers, and exporters). Additionally, any manufacturer
                that uses MAPA for legitimate P2P, methamphetamine, and amphetamine
                production would already be registered with DEA and have all security
                and other handling processes in place, resulting in minimal cost.
                ---------------------------------------------------------------------------
                 \22\ 5 U.S.C. 601-612.
                ---------------------------------------------------------------------------
                 DEA has identified five domestic suppliers of MAPA, only one of
                which is registered with DEA to handle list I chemicals. Based on Small
                Business Administration (SBA) size standards for chemical distributors
                and Statistics of U.S. Business data, each of the five suppliers are
                small entities because their revenues are below SBA's $150 million
                threshold. It is difficult to estimate the quantity of MAPA these
                suppliers distribute. Chemical distributors often have items in their
                catalog while not actually having any material level of sales. Based on
                the review of established aggregate production quota for P2P (40 grams
                for 2019), legal conversion of MAPA to P2P in the United States is
                limited to small, gram quantities. DEA believes any quantity of sales
                of MAPA from these distributors for legitimate P2P manufacturing is
                minimal. Therefore, DEA estimates the cost of this proposed rule on any
                affected small entity is minimal. DEA welcomes any public comment
                regarding this estimate. Based on these factors, DEA projects that this
                proposed rule, if promulgated, will not result in a significant
                economic impact on a substantial number of small entities.
                Unfunded Mandates Reform Act of 1995
                 On the basis of information contained in the RFA section above, DEA
                has determined and certifies pursuant to the Unfunded Mandates Reform
                Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., that this action would not
                result in any Federal mandate that may result ``in the expenditure by
                State, local, and tribal governments, in the aggregate, or by the
                private sector, of $100,000,000 or more (adjusted annually for
                inflation) in any 1 year * * *.'' Therefore, neither a Small Government
                Agency Plan nor any other action is required under provisions of UMRA.
                [[Page 16564]]
                Paperwork Reduction Act
                 This proposed action does not impose a new collection of
                information requirement under the Paperwork Reduction Act, 44 U.S.C.
                3501-3521. This proposed action would not impose recordkeeping or
                reporting requirements on State or local governments, individuals,
                businesses, or organizations. An agency may not conduct or sponsor, and
                a person is not required to respond to, a collection of information
                unless it displays a currently valid OMB control number.
                List of Subjects in 21 CFR Part 1310
                 Administrative practice and procedure, Drug traffic control,
                Exports, Imports, Reporting and recordkeeping requirements.
                 Accordingly, for the reasons set forth in the preamble, DEA
                proposes to further amend 21 CFR part 1310, as proposed to be amended
                at 85 FR 82984 (December 21, 2020) as follows:
                PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
                MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES
                0
                1. The authority citation for 21 CFR part 1310 continues to read as
                follows:
                 Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
                0
                2. In Sec. 1310.02, add paragraph (a)(37) to read as follows:
                Sec. 1310.02 Substances covered.
                * * * * *
                 (a) * * *
                (37) methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo- 8795
                 2-phenylbutanoate) and its optical isomers.............
                
                * * * * *
                0
                3. In Sec. 1310.04:
                0
                a. Redesignate paragraphs (g)(1)(x) through (xvi) as paragraphs
                (g)(1)(xi) through (xvii), respectively; and
                0
                b. Add new paragraph (g)(1)(x).
                 The addition reads as follows:
                Sec. 1310.04 Maintenance of records.
                * * * * *
                 (g) * * *
                 (1) * * *
                 (x) methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-
                phenylbutanoate) and its optical isomers.
                * * * * *
                0
                4. In Sec. 1310.09, add paragraph (r) to read as follows:
                Sec. 1310.09 Temporary exemption from registration.
                * * * * *
                 (r)(1) Each person required under 21 U.S.C. 822 and 957 to obtain a
                registration to manufacture, distribute, import, or export regulated
                forms of methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-
                phenylbutanoate) and its optical isomers, including regulated chemical
                mixtures pursuant to Sec. 1310.12, is temporarily exempted from the
                registration requirement, provided that DEA receives a properly
                completed application for registration or application for exemption for
                a chemical mixture containing regulated forms of MAPA pursuant to Sec.
                1310.13 on or before 30 days after the publication of a rule finalizing
                this action. The exemption would remain in effect for each person who
                has made such application until the Administration has approved or
                denied that application. This exemption applies only to registration;
                all other chemical control requirements set forth in the Act and parts
                1309, 1310, 1313, and 1316 of this chapter remain in full force and
                effect.
                 (2) Any person who manufactures, distributes, imports, or exports a
                chemical mixture containing regulated forms of methyl alpha-
                phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate) and its
                optical isomers whose application for exemption is subsequently denied
                by DEA must obtain a registration with DEA. A temporary exemption from
                the registration requirement would also be provided for those persons
                whose application for exemption is denied, provided that DEA receives a
                properly completed application for registration on or before 30 days
                following the date of official DEA notification that the application
                for exemption has been denied. The temporary exemption for such persons
                would remain in effect until DEA takes final action on their
                registration application.
                0
                5. In Sec. 1310.12, in the Table of Concentration Limits under List I
                Chemicals in paragraph (c), add an entry for methyl alpha-
                phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate) in
                alphabetical order to read as follows:
                Sec. 1310.12 Exempt chemical mixtures.
                * * * * *
                 (c) * * *
                 Table of Concentration Limits
                ----------------------------------------------------------------------------------------------------------------
                 DEA chemical
                 code No. Concentration Special conditions
                ----------------------------------------------------------------------------------------------------------------
                 List I Chemicals
                ----------------------------------------------------------------------------------------------------------------
                
                 * * * * * * *
                methyl alpha-phenylacetoacetate (MAPA; 8795 Not exempt at any Chemical mixtures
                 methyl 3-oxo-2-phenylbutanoate) and concentration. containing any amount of
                 its optical isomers. MAPA and its optical
                 isomers are not exempt.
                
                 * * * * * * *
                ----------------------------------------------------------------------------------------------------------------
                [[Page 16565]]
                * * * * *
                D. Christopher Evans,
                Acting Administrator.
                [FR Doc. 2021-05346 Filed 3-29-21; 8:45 am]
                BILLING CODE 4410-09-P
                

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