[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Rules and Regulations]
[Pages 21101-21102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07335]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-1003]


Specific Listing for Eutylone, a Currently Controlled Schedule I 
Substance

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is establishing a 
specific listing and DEA Controlled Substances Code Number (drug code) 
for 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)butan-1-one (also known as 
eutylone or bk-EBDB) in schedule I of the Controlled Substances Act 
(CSA). Although eutylone is not specifically listed in schedule I of 
the CSA with its own unique drug code, it has been controlled in the 
United States since March 7, 2014, as a positional isomer of pentylone, 
a schedule I hallucinogen. Therefore, DEA is simply amending the 
schedule I hallucinogenic substances list in its regulations to 
separately include eutylone.

DATES: Effective April 10, 2023.

FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and 
Chemical Evaluation, Diversion Control Division, Drug Enforcement 
Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION: 

Eutylone Control

    Eutylone (also known as 1-(1,3-benzodioxol-5-yl)-2-
(ethylamino)butan-1-one or bk-EBDB) is a chemical substance which is 
structurally related to pentylone (also known as 1-(1,3-benzodioxol-5-
yl)-2-(methylamino)pentan-1-one or bk-MBDP). Pentylone is listed as a 
hallucinogenic substance in schedule I at 21 CFR 1308.11(d)(64). The 
introductory text to paragraph (d) provides: (1) A listed 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 (2) the term ``isomer'' 
includes the optical, position[al], and geometric isomers.
    When compared to the chemical structure of pentylone, eutylone 
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 pentylone and eutylone possess the same molecular formula and core 
structure, and they have the same functional groups. They only differ 
from one another by a rearrangement of an alkyl moiety between 
functional groups. Accordingly, under 21 CFR 1308.11(d), eutylone, as a 
positional isomer of pentylone, has been and continues to be a schedule 
I controlled substance.\1\
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    \1\ Pentylone (and its isomers) has been subject to temporary 
schedule I controls since March 7, 2014, first pursuant to a final 
order (March 7, 2014, 79 FR 12938) and the subsequent one-year 
extension of that order (March 4, 2016, 81 FR 11429), and then 
permanently pursuant to a final rule which continued the imposition 
of those controls (March 1, 2017, 82 FR 12171).
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The Drug Enforcement Administration (DEA)'s Authority To Control 
Eutylone

    This rule is prompted by a letter dated May 27, 2022, in which the 
United States government was informed by the Secretariat of the United 
Nations that eutylone has been added to Schedule II of the Convention 
on Psychotropic Substances of 1971 (1971 Convention). This letter was 
prompted by a decision at the 65th Session of the Commission on 
Narcotic Drugs (CND) in March 2022 to schedule eutylone under Schedule 
II of the 1971 Convention (CND Dec/65/3). Preceding this decision, 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, 
July 23, 2021, 86 FR 39038 and February 15, 2022, 87 FR 8586. In every 
instance, FDA noted that eutylone was already controlled in schedule I 
of the Controlled Substances Act (CSA) as a positional isomer of 
pentylone, and the February 2022 notice stated that no additional 
permanent controls for eutylone under the CSA would be necessary to 
fulfill United States' obligations as a party to the 1971 Convention.
    As discussed above in this final rule, eutylone--by virtue of being 
a positional isomer of pentylone--has been controlled in schedule I of 
the CSA temporarily since March 7, 2014 (79 FR 12938), and permanently 
since March 1, 2017 (82 FR 12171). Therefore, all regulations and 
criminal sanctions applicable to schedule I substances have been and 
remain applicable to eutylone. 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 eutylone as a schedule I controlled substance in any way. This 
action, as an administrative matter, merely establishes a separate, 
specific listing for eutylone in schedule I of the CSA and assigns a 
DEA controlled substances code number (drug code) for the substance. 
This action will allow DEA to establish an aggregate production quota 
and grant individual manufacturing and procurement quotas to DEA-
registered manufacturers of eutylone, who had previously been granted 
individual quotas for such purposes under the drug code for pentylone.

Regulatory Analyses

Administrative Procedure Act

    An agency may find good cause to exempt a rule from certain 
provisions of the Administrative Procedure Act (APA) (5 U.S.C. 553), 
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. Eutylone is currently controlled in 
schedule I as a positional isomer of pentylone, and eutylone has no 
currently accepted medical use in treatment to qualify for placement in 
a schedule other than schedule I (see 21 U.S.C. 812(b)(2)-(5)).
    Pursuant to 5 U.S.C. 553(b)(3)(B), DEA finds that notice and 
comment rulemaking is unnecessary and that good cause exists to 
dispense with these procedures. The addition of a separate listing for 
eutylone 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.'' National Nutritional 
Foods Ass'n v. Kennedy, 572 F.2d 377, 385 (2d Cir. 1978) (quoting S. 
Rep. No. 79-752, at 200 (1945)). See also Utility Solid Waste 
Activities Group v. E.P.A., 236 F.3d 749, 755 (D.C. Cir. 2001) (the 
``unnecessary'' prong ``is confined to those situations in which the 
administrative rule is a routine determination, insignificant in nature

[[Page 21102]]

and impact, and inconsequential to the industry and public'') (internal 
quotations and citation omitted). 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, 
publishing a notice of proposed rulemaking and soliciting public 
comment are unnecessary.
    In addition, because eutylone is already subject to domestic 
control under schedule I as a positional isomer of pentylone and no 
additional requirements are 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). DEA is concerned 
that delaying the effective date of this rule potentially could cause 
confusion regarding the regulatory status of eutylone. Eutylone is 
currently controlled as a schedule I controlled substance, and this 
level of control does not change with this rulemaking.

Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    This regulation has been drafted and reviewed in accordance with 
the principles of Executive Orders (E.O.) 12866 and 13563. This rule is 
not a significant regulatory action under E.O. 12866. Eutylone already 
is a controlled substance in the United States under schedule I, as it 
is a positional isomer of a schedule I hallucinogen, pentylone. In this 
final rule, DEA is merely making an administrative change by amending 
its regulations to separately list eutylone in schedule I and to assign 
the DEA controlled substances code number 7549 to the substance. A 
separate listing for eutylone and its DEA controlled substances code 
number will not alter the status of eutylone as a schedule I controlled 
substance. Accordingly, this rule has not been reviewed by the Office 
of Management and Budget (OMB).

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) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment under section 553(b) of 
the APA or other laws. 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. 44 U.S.C. 3501-
3521. 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 OMB 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.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

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

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1308 continues to read as follows:

    Authority:  21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.


0
2. Amend Sec.  1308.11 by adding new paragraph (d)(101) to read as 
follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

(101) 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)butan-1-one (other     7549
 names: eutylone; bk-EBDB).....................................
 

* * * * *

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
April 3, 2023, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-07335 Filed 4-7-23; 8:45 am]
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