[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Rules and Regulations]
[Pages 34967-34969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10295]


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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.

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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 34968]]

    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\
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    \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).
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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 34969]]

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