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Federal Register / Vol. 86, No. 59 / Tuesday, March 30, 2021 / Proposed Rules
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.
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
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. 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
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.

19 21

CFR 1310.05d.
U.S.C. 830b and 21 CFR 1310.05a and b.
21 21 U.S.C. 880.
20 21

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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 Presidents 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 3f.
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 IIcontrolled 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
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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 1309.21. Even with the possibility of these additional registrations, DEA believes that the cost would be minimal.

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