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Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations application for exemption for those mixtures that do not meet the category criteria set forth in 21 CFR 1310.12d 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.
80239Avi and 21 CFR
1310.13a12.

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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
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, 6 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.
8 21 U.S.C. 822c2 and 21 U.S.C. 957b1B.
7 21

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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.
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. 830a and b1 and 2 and in accordance with 21 CFR 1310.04 and 9 See
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21 CFR 1309.23b1.

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1310.05. Pursuant to 21 CFR 1310.04a, 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.
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
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. 880a and 21 CFR
1316.02c. The CSA allows for administrative inspections of these controlled premises as provided in 21
CFR part 1316, subpart A. 21 U.S.C.
880b.
10 21 CFR 1310.05d. See also 21 U.S.C.
830b2.
11 21 U.S.C. 830b1AC and 21 CFR
1310.05a and b1.

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