Rule2023-07335
Specific Listing for Eutylone, a Currently Controlled Schedule I Substance
Primary source
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Published
April 10, 2023
Effective
April 10, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 68 (Monday, April 10, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on April 10, 2023.
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