Listing of Ethylone in Schedule I of Controlled Substances and Assignment of an Administration Controlled Substances Code Number
| Published date | 08 June 2020 |
| Citation | 85 FR 34607 |
| Record Number | 2020-10295 |
| Section | Rules and Regulations |
| Court | Drug Enforcement Administration |
Federal Register, Volume 85 Issue 110 (Monday, June 8, 2020)
[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Rules and Regulations]
[Pages 34607-34609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10295]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-510]
Listing of Ethylone in Schedule I of Controlled Substances and
Assignment of an Administration Controlled Substances Code Number
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This is a final rule issued by the Drug Enforcement
Administration (DEA) establishing a specific listing and administration
controlled substances code number for ethylone (also known as 1-(1,3-
benzodioxol-5-yl)-2-(ethylamino)propan-1-one; 3,4-methylenedioxy-N-
ethylcathinone; bk-MDEA; MDEC) in schedule I of the Controlled
Substances Act (CSA).
DATES: Effective June 8, 2020.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 362-3261.
SUPPLEMENTARY INFORMATION:
Ethylone Control
Ethylone (1-(1,3-benzodioxol-5-yl)-2-(ethylamino)propan-1-one; 3,4-
methylenedioxy-N-ethylcathinone; bk-MDEA; MDEC) is a chemical substance
which is structurally related to butylone. Butylone is listed as a
hallucinogenic substance in schedule I at 21 CFR 1308.11(d)(62), which
includes ``any of its salts, isomers, and salts of isomers whenever the
existence of such salts, isomers, and salts of isomers is possible,''
and for which ``the term `isomer' includes the optical, position and
geometric isomers.'' When compared to the chemical structure of
butylone, ethylone meets the statutory definition of a positional
isomer in 21 CFR 1300.01(b). Both butylone and ethylone possess the
same molecular formula, core structure, and 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), ethylone has been and continues to be a schedule I
controlled substance.
DEA's Authority To Control Ethylone
This rule is prompted by a letter dated April 21, 2017, in which
the United States Government was informed by the Secretary-General of
the United Nations that ethylone 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 60th Session of the Commission
on Narcotic Drugs in March 2017 to schedule ethylone under Schedule II
of the 1971 Convention. Preceding this decision, the Food and Drug
Administration (FDA), on behalf of the Secretary of Health and Human
Services (HHS), published notice in the Federal Register with an
opportunity to submit domestic information and opportunity to comment
on this action, 81 FR 64162 and 82 FR 3326. In both instances, FDA
noted that ethylone was already controlled as a positional isomer of
butylone, and that no additional controls would be necessary. However,
as a signatory Member State to the 1971 Convention, the United States
is obligated to control ethylone under its national drug control
legislation, i.e., the CSA.
[[Page 34608]]
Ethylone is currently controlled domestically in schedule I of the
CSA as a positional isomer of butylone, and, as such, all regulations
and criminal sanctions applicable to schedule I substances have been
and remain applicable to ethylone. 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. Article 23 of the 1971
Convention allows for adoption of stricter domestic measures of control
than those required under the Convention, if those measures are
desirable or necessary for the protection of the public health and
welfare.
This action has the net effect of establishing a specific listing
for ethylone in schedule I of the CSA and assigns an Administration
Controlled Substances Number 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
ethylone who had previously been granted individual quotas for such
purposes under drug code for butylone.
Regulatory Analyses
Administrative Procedure Act
An agency may find good cause to exempt a rule from certain
provisions of the Administrative Procedure Act (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. This rule is promulgated in order to
comply with international treaty obligations, and because ethylone is
currently controlled in schedule I and has no accepted medical use, DEA
has no discretion with respect to these changes.
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 because the inclusion of ethylone and its
Administration Controlled Substances Code Number in the list of
schedule I substances in 21 CFR 1308.11(b) 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 and impact, and inconsequential to the industry
and public'') (int. quotations and citation omitted). This rule is a
``technical amendment'' to 21 CFR 1308.11(b) 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 ethylone is already subject to domestic
control under schedule I as a positional isomer of butylone 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). As ethylone is
already subject to domestic control under schedule I and no additional
requirements are being imposed through this action, DEA believes that
delaying the effective date of this rule could cause confusion
regarding the regulatory status of ethylone. Ethylone is currently
controlled as a schedule I controlled substance, and this level of
control does not change with this rulemaking.
Executive Order 12866, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs
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. Ethylone has been
controlled in the United States as a positional isomer of a schedule I
hallucinogen. In this final rule, DEA is merely amending its
regulations to formally list ethylone in schedule I and to assign the
Administration Controlled Substances Code Number 7547 to the substance.
Listing ethylone and its Administration Controlled Substances Code
Number will not alter the status of ethylone as a schedule I controlled
substance. Accordingly, this rule has not been reviewed by the Office
of Management and Budget (OMB).
Because this final rule is not significant under E.O. 12866, it is
not subject to the requirements of E.O. 13771.\1\
---------------------------------------------------------------------------
\1\ Office of Mgmt. & Budget, Exec. Office of The President,
Interim Guidance Implementing Section 2 of the Executive Order of
January 30, 2017 Titled ``Reducing Regulation and Controlling
Regulatory Costs'' (Feb. 2, 2017).
---------------------------------------------------------------------------
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 Civil Justice Reform 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 explained above, the DEA determined that
there was good cause to exempt this final rule from notice and comment.
Consequently, the RFA does not apply to this interim final rule.
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 million or more (adjusted for inflation) in any one
year.'' Therefore, neither a Small Government Agency Plan nor any other
action is required under UMRA of 1995.
[[Page 34609]]
Congressional Review Act
This rule is not a major rule as defined by section 804 of 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, 21 CFR part 1308 is amended 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 paragraph (d)(80), to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(80) 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)propan-1-one (ethylone)
7547.
* * * * *
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-10295 Filed 6-5-20; 8:45 am]
BILLING CODE 4410-09-P
