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Federal Register / Vol. 86, No. 59 / Tuesday, March 30, 2021 / Proposed Rules provisions of 21 CFR 1310.04g.
Therefore, DEA is proposing that all MAPA transactions, regardless of size, would be regulated transactions as defined in 21 CFR 1300.02b. 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 1310.05d.
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
1310.12c to reflect the fact that chemical mixtures containing any amount of MAPA are subject to CSA
chemical control provisions.

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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 1310.12d for an automatic exemption. Pursuant to 21 CFR 1310.13a, DEA may grant an exemption of a chemical mixture, by
publishing a final rule in the Federal Register, if DEA determines that: 1 The mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance, and 2 the listed chemical or chemicals cannot be readily recovered.
Requirements for Handling List I
Chemicals If finalized as proposed, the designation of MAPA as a list I chemical would subject handlers manufacturers, distributors, importers, and exporters and proposed handlers to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of a list I
chemical. Upon publication of a final rule, persons potentially handling MAPA, including regulated chemical mixtures containing MAPA, would be required to comply with the following list I chemical regulations:
1. Registration. Any person who handles manufactures, distributes, imports, or exports, or proposes to engage in such handling of, MAPA or a chemical mixture containing MAPA
must obtain a registration pursuant to 21
U.S.C. 822, 823, 957, and 958.
Regulations describing registration for list I chemical handlers are set forth in 21 CFR part 1309. DEA regulations require separate registrations for manufacturing, distributing, importing, and exporting of MAPA.15 Further, a separate registration is required for each principal place of business at one general physical location where list I
chemicals are manufactured, distributed, imported, or exported by a person.16
DEA notes that under the CSA, warehousemen are not required to register and may lawfully possess list I
chemicals, if the possession of those chemicals is in the usual course of business or employment.17 Under DEA
implementing regulations, the warehouse in question must receive the list I chemical from a DEA registrant and shall only distribute the list I
chemical back to the DEA registrant and registered location from which it was received.18 A warehouse that distributes list I chemicals to persons other than the registrant and registered location from which they were obtained is conducting distribution activities and is required to register as such.
15 21

CFR 1309.21.
CFR 1309.23a. See also 21 U.S.C. 822e1
with separate registration requirements pertaining to manufacturing or distributing a list I chemical.
17 21 U.S.C. 822c2 and 21 U.S.C. 957b1B.
18 See 21 CFR 1309.23b1.
16 21

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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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.
830a and b1 and 2 and in accordance with 21 CFR 1310.04 and 1310.05. Pursuant to 21 CFR 1310.04, a record must be made and maintained for two years after the date of a transaction involving a listed chemical, provided the transaction is a regulated transaction.
Each regulated bulk manufacturer of a listed chemical would be required to submit manufacturing, inventory, and
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