SUPPLEMENTARY INFORMATION:

3-Chloromethcathinone Control

3-Chloromethcathinone (also known as, 1-(3-chlorophenyl)-2-(methylamino)propan-1-one; and 3-CMC) is a chemical substance that is structurally related to 4-chloromethcathinone (also known as, 1- ( printed page 70010) (4-chlorophenyl)-2-(methylamino)propan-1-one; and 4-CMC). 4-Chloromethcathinone is listed as a hallucinogenic substance in schedule I at 21 CFR 1308.11(d)(106). As stated in subsection 21 CFR 1308.11(d), a listed hallucinogenic substance includes “any of its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation,” and the term “isomer” includes the “optical, position[al], and geometric isomers.”

When compared to the chemical structure of 4-chloromethcathinone, 3-chloromethcathinone meets the definition of a “positional isomer” in 21 CFR 1300.01(b), which cross-references the term “positional isomer” in 21 CFR 1308.11(d). Both 4-chloromethcathinone and 3-chloromethcathinone possess the same molecular formula and core structure, and they have the same functional groups. 4-Chloromethcathinone and 3-chloromethcathinone differ from one another by the position of the chloride atom on the same functional group (phenyl ring). This does not create new chemical functionalities or destroy existing chemical functionalities. Accordingly, under 21 CFR 1308.11(d), 3-chloromethcathinone, as a positional isomer of 4-chloromethcathinone, has been and continues to be a schedule I controlled substance.^[1]

Legal Authority

This rule is prompted by a letter dated June 6, 2024, in which the Secretariat of the United Nations informed the United States government that 3-chloromethcathinone have been added to Schedule II of the Convention on Psychotropic Substances of 1971 (1971 Convention), February 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended. This letter was prompted by decisions at the 67th Session of the Commission on Narcotic Drugs (CND) in March 2024 to schedule 3-chloromethcathinone under Schedule II of the 1971 Convention (CND Decision 67/2). Preceding these decisions, the Food and Drug Administration (FDA), on behalf of the Secretary of Health and Human Services and pursuant to 21 U.S.C. 811(d)(2), published two notices in the Federal Register with an opportunity to submit domestic information and opportunity to comment on this action.^[2]

As discussed above in this final rule, 3-chloromethcathinone, by virtue of being a positional isomer of 4-chloromethcathinone, has been controlled in schedule I of the CSA since December 17, 2025.^[3] Therefore, all regulations and criminal sanctions applicable to schedule I substances have been and remain applicable to 3-chloromethcathinone. Drugs controlled in schedule I of the CSA satisfy and exceed the required domestic controls of Schedule II under Article 2 of the 1971 Convention.

Effect of Action

As discussed above, this rule does not affect the continuing status of 3-chloromethcathinone as a schedule I controlled substances in any way. This action, as an administrative matter, merely establishes a separate, specific listing for 3-chloromethcathinone in schedule I of the CSA and assigns a DEA controlled substances code number (drug code) for this substance. This action will allow DEA to establish an aggregate production quota and grant individual manufacturing and procurement quotas to DEA-registered manufacturers of 3-chloromethcathinone, who had previously been granted individual quotas for such purposes under the drug code for 4-chloromethcathinone.

Regulatory Analyses

Administrative Procedure Act

An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (APA) including notice of proposed rulemaking and the opportunity for public comment, if it is determined to be unnecessary, impracticable, or contrary to the public interest.^[4]

Pursuant to 5 U.S.C. 553(b)(B), DEA finds that notice-and-comment rulemaking is unnecessary, and that good cause exists to dispense with these procedures, as 3-chloromethcathinone is currently controlled in schedule I as a positional isomer of 4-chloromethcathinone. The addition of a separate listing for 3-chloromethcathinone and its DEA controlled substances code number in the list of schedule I substances in 21 CFR 1308.11(d) makes no substantive difference in the status of this drug as a schedule I controlled substance, but instead is “a minor or merely technical amendment in which the public is not particularly interested.” ^[5] This rule is a “technical amendment” to 21 CFR 1308.11(d) as it is “insignificant in nature and impact, and inconsequential to the industry and public.” Therefore, DEA finds that publishing a notice of proposed rulemaking and soliciting public comment are unnecessary and good cause exists to dispense with these procedures.

In addition, DEA is concerned that delaying the effective date of this rule potentially could cause confusion regarding the regulatory status of 3-chloromethcathinone. With 3-chloromethcathinone currently controlled under schedule I as a positional isomer, and with no additional requirements being imposed through this action, DEA finds good cause exists to make this rule effective immediately upon publication in accordance with 5 U.S.C. 553(d)(3).

Executive Orders 12866, 13563, 14192, and 14294 (Regulatory Review).

This regulation has been drafted and reviewed in accordance with the principles of Executive Orders (E.O.) 12866, 13563, and 14192. This rule is not a significant regulatory action under section 3(f) of E.O. 12866. 3-Chloromethcathinone is already a controlled substance in the United States under schedule I, as it is a positional isomer of the schedule I hallucinogen 4-chloromethcathinone. In this final rule, DEA is merely making an administrative change by amending its regulations to separately list 3-chloromethcathinone in schedule I and to assign a DEA controlled substances code number to this substance. A separate listing for 3-chloromethcathinone and its DEA controlled substances code number will not alter the status of this substance as a schedule I controlled substance. DEA scheduling actions are not subject to E.O. 14192, Unleashing Prosperity Through Deregulation, or E.O. 14294, Fighting Overcriminalization in Federal Regulations. ( printed page 70011)

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, provide a clear legal standard 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 on 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

The Regulatory Flexibility Act (RFA) applies to rules that are subject to the notice-and-comment requirements under the APA or other laws.^[6] As noted in the above section regarding the applicability of the APA, DEA determined that there was good cause to exempt this final rule from notice and comment. Consequently, the RFA does not apply.

Paperwork Reduction Act of 1995

This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995.^[7] This 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 Office of Management and Budget control number.

Unfunded Mandates Reform Act of 1995

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1532, DEA has determined 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 UMRA of 1995.

Congressional Review Act

This 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 rule to both Houses of Congress and to the Comptroller General.

For the reasons set out above, DEA amends 21 CFR part 1308 as follows:

91 FR 70009