[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Proposed Rules]
[Pages 27520-27523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12669]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / 
Proposed Rules  

[[Page 27520]]



DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-482]


Schedules of Controlled Substances: Temporary Placement of N-
Ethylpentylone in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Proposed amendment; notice of intent.

-----------------------------------------------------------------------

SUMMARY: The Acting Administrator of the Drug Enforcement 
Administration is publishing this notice of intent to issue an order 
temporarily scheduling N-1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-1-
pentanone (N-ethylpentylone, ephylone) in schedule I. This action is 
based on a finding by the Acting Administrator that the placement of N-
ethylpentylone in schedule I is necessary to avoid an imminent hazard 
to the public safety. When it is issued, the temporary scheduling order 
will impose regulatory requirements under the Controlled Substances Act 
(CSA) on the manufacture, distribution, reverse distribution, 
possession, importation, exportation, research, and conduct of 
instructional activities, and chemical analysis of N-ethylpentylone, as 
well as administrative, civil, and criminal remedies with respect to 
persons who fail to comply with such requirements or otherwise violate 
the CSA with respect to N-ethylpentylone.

DATES: June 13, 2018.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: This notice of intent is issued pursuant to 
the temporary scheduling provisions of 21 U.S.C. 811(h). The Drug 
Enforcement Administration (DEA) intends to issue a temporary order (in 
the form of a temporary amendment) placing N-ethylpentylone in schedule 
I of the Controlled Substances Act (CSA).\1\ The temporary scheduling 
order will be published in the Federal Register on or after July 13, 
2018.
---------------------------------------------------------------------------

    \1\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this notice of intent 
adheres to the statutory language of 21 U.S.C. 811(h), which refers 
to a ``temporary scheduling order.'' No substantive change is 
intended.
---------------------------------------------------------------------------

Legal Authority

    Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney 
General with the authority to temporarily place a substance in schedule 
I of the CSA for two years without regard to the requirements of 21 
U.S.C. 811(b) if he finds that such action is necessary to avoid an 
imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, 
if proceedings to control a substance permanently are initiated under 
21 U.S.C. 811(a)(1) while the substance is temporarily controlled under 
section 811(h), the Attorney General may extend the temporary 
scheduling for up to one year. 21 U.S.C. 811(h)(2).
    Where the necessary findings are made, a substance may be 
temporarily scheduled if it is not listed in any other schedule under 
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or 
approval in effect for the substance under section 505 of the Federal 
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 
811(h)(1); 21 CFR part 1308. The Attorney General has delegated 
scheduling authority under 21 U.S.C. 811 to the Administrator of the 
DEA. 28 CFR 0.100.

Background

    Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the 
Administrator to notify the Secretary of the Department of Health and 
Human Services (HHS) of his intention to temporarily place a substance 
in schedule I of the CSA.\2\ The Acting Administrator transmitted 
notice of his intent to place N-ethylpentylone in schedule I on a 
temporary basis to the Acting Assistant Secretary for Health of HHS by 
letter dated November 22, 2017. The Acting Assistant Secretary 
responded to this notice of intent by letter dated December 13, 2017, 
and advised that based on a review by the Food and Drug Administration 
(FDA), there are currently no active investigational new drug 
applications or approved new drug applications for N-ethylpentylone. 
The Acting Assistant Secretary also stated that the HHS has no 
objection to the temporary placement of N-ethylpentylone in schedule I 
of the CSA. N-Ethylpentylone is not currently listed in any schedule 
under the CSA, and no exemptions or approvals are in effect for this 
substance under section 505 of the FDCA, 21 U.S.C. 355.
---------------------------------------------------------------------------

    \2\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS 
in carrying out the Secretary's scheduling responsibilities under 
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of the HHS has delegated to the Assistant Secretary for 
Health of the HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
---------------------------------------------------------------------------

    To find that placing a substance temporarily in schedule I of the 
CSA is necessary to avoid an imminent hazard to the public safety, the 
Administrator is required to consider three of the eight factors set 
forth in 21 U.S.C. 811(c): The substance's history and current pattern 
of abuse; the scope, duration and significance of abuse; and what, if 
any, risk there is to the public health. 21 U.S.C. 811(h)(3). 
Consideration of these factors includes actual abuse, diversion from 
legitimate channels, and clandestine importation, manufacture, or 
distribution. 21 U.S.C. 811(h)(3).
    A substance meeting the statutory requirements for temporary 
scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). 
Substances in schedule I are those that have a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. 21 U.S.C. 812(b)(1).

N-Ethylpentylone

    Around 2014, the synthetic cathinone, N-ethylpentylone, emerged in 
the United States' illicit drug market after the scheduling of other 
popular synthetic cathinones (e.g., ethylone, 4-methyl-N-ethylcathinone 
(4-MEC), mephedrone, methylone, pentylone, and 3,4-
methylenedioxymethamphetamine (MDPV)). The identification of N-
ethylpentylone in forensic evidence and overdose deaths indicates that 
this substance is being misused and abused. Law enforcement encounters 
include those reported to the National Forensic

[[Page 27521]]

Laboratory Information System (NFLIS), a DEA sponsored program that 
systematically collects drug identification results and associated 
information from drug cases analyzed by Federal, State, and local 
forensic laboratories, the System to Retrieve Information from Drug 
Evidence (STRIDE), a federal database for the drug samples analyzed by 
DEA forensic laboratories, and STARLiMS (a web-based, commercial 
laboratory information management system that replaced STRIDE in 2014). 
Forensic laboratories have analyzed drug exhibits received from State, 
local, or Federal law enforcement agencies that were found to contain 
N-ethylpentylone.\3\ NFLIS registered over 6,000 reports from state and 
local forensic laboratories identifying this substance in drug-related 
exhibits for a period from January 2013 to December 2017 from 41 
states. N-Ethylpentylone was first identified in NFLIS in May 2014. 
STRIDE/STARLiMS registered over 300 reports from DEA forensic 
laboratories from January 2013 to December 2017. N-Ethylpentylone was 
first reported to STRIDE/STARLiMS in December 2015. Additionally, 
encounters of N-ethylpentylone have occurred by the U.S. Customs and 
Border Protection (CBP).
---------------------------------------------------------------------------

    \3\ NFLIS and STRIDE/STARLiMS databases were queried on February 
8, 2018.
---------------------------------------------------------------------------

    N-Ethylpentylone, like other synthetic cathinones, is a designer 
drug of the phenethylamine class and it is pharmacologically similar to 
schedule I synthetic cathinones (e.g., cathinone, methcathinone, 
mephedrone, methylone, pentylone, and MDPV) and well-known schedule I 
and II sympathomimetic agents (e.g., methamphetamine, 3,4-
methylenedioxymethamphetamine (MDMA), and cocaine). N-ethylpentylone, 
similar to these substances, causes stimulant related psychological and 
somatic effects. Consequently, there have been documented reports of 
emergency room admissions and numerous deaths associated with the abuse 
of N-ethylpentylone. No approved medical use has been identified for 
this substance, nor has it been approved by the FDA for human 
consumption.
    Available data and information for N-ethylpentylone, summarized 
below, indicate that this substance has a high potential for abuse, no 
currently accepted medical use in treatment in the United States, and a 
lack of accepted safety for use under medical supervision. The DEA's 
three-factor analysis is available in its entirety under ``Supporting 
and Related Material'' of the public docket for this action at 
www.regulations.gov under Docket Number DEA-482.

Factor 4. History and Current Pattern of Abuse

    N-Ethylpentylone is a synthetic cathinone of the phenethylamine 
class and it is structurally and pharmacologically similar to 
cathinone, methcathinone, mephedrone, methylone, pentylone, MDPV, 
methamphetamine, MDMA, and other schedule I and II substances. Thus, it 
is highly likely that N-ethylpentylone is abused in the same manner and 
by the same users as these substances. That is, N-ethylpentylone, like 
these substances, is most likely ingested by swallowing capsules or 
tablets or snorted by nasal insufflation of the powder tablets. 
Products containing N-ethylpentylone, similar to schedule I synthetic 
cathinones, are likely to be falsely marketed as ``research 
chemicals,'' ``jewelry cleaner,'' ``stain remover,'' ``plant food or 
fertilizer,'' ``insect repellants'' or ``bath salts,'' sold at smoke 
shops, head shops, convenience stores, adult book stores, and gas 
stations, and purchased on the internet. Like those seen with 
commercial products that contain synthetic cathinones, the packages of 
products that contain N-ethylpentylone also probably contain the 
warning ``not for human consumption,'' most likely in an effort to 
circumvent statutory restrictions for these substances. Demographic 
data collected from published reports and mortality records suggest 
that the main users of N-ethylpentylone, similar to schedule I 
synthetic cathinones and MDMA, are young adults.
    Available evidence suggests that the history and pattern of abuse 
of N-ethylpentylone parallels that of MDMA, methamphetamine, or cocaine 
and that N-ethylpentylone has been marketed as a replacement for these 
substances. N-Ethylpentylone has been identified in law enforcement 
seizures that were initially suspected to be MDMA. In addition, there 
are reports that abusers of N-ethylpentylone thought they were using 
MDMA or another illicit substance but toxicological analysis revealed 
that the psychoactive substance was N-ethylpentylone. Toxicology 
reports also revealed that N-ethylpentylone is being ingested with 
other substances including other synthetic cathinones, common cutting 
agents, or other recreational substances. Consequently, products 
containing synthetic cathinones, including N-ethylpentylone, are 
distributed to users, often with unpredictable outcomes. Thus, the 
recreational abuse of synthetic cathinones, including N-ethylpentylone, 
is a significant concern.

Factor 5. Scope, Duration and Significance of Abuse

    N-Ethylpentylone is a popular recreational drug that emerged on the 
United States' illicit drug market after the scheduling of other 
popular synthetic cathinones (e.g., ethylone, mephedrone, methylone, 
pentylone, and MDPV) (see DEA 3-Factor Analysis for a full discussion). 
Forensic laboratories have confirmed the presence of N-ethylpentylone 
in drug exhibits received from state, local, and federal law 
enforcement agencies. Law enforcement data show that N-ethylpentylone 
first appeared in the illicit drug market in 2014 with one encounter 
and began increasing thereafter.\4\ In 2015, NFLIS registered five 
reports from three states regarding N-ethylpentylone. However, in 2016, 
there were 2,074 reports from 39 states and, in 2017, there were 3,955 
reports from 39 states related to this substance registered in NFLIS. 
N-Ethylpentylone represented 60% of all synthetic cathinones 
encountered by local law enforcement agencies and reported to NFLIS in 
2017. From January 2013 to December 2017, NFLIS registered 6,035 
reports from state and local forensic laboratories identifying this 
substance in drug-related exhibits from 41 states. STRIDE/STARLiMS 
registered over 338 reports from DEA forensic laboratories during 
January 2013 to December 2017. Additionally, seizures of N-
ethylpentylone have occurred by the U.S. Customs and Border Protection 
(CBP) beginning in 2016. Concerns over the continuing abuse of 
synthetic cathinones have led to the control of many synthetic 
cathinones.
---------------------------------------------------------------------------

    \4\ NFLIS and STRIDE/STARLiMS databases were queried on February 
8, 2018.
---------------------------------------------------------------------------

Factor 6. What, if Any, Risk There Is to the Public Health

    The identification of N-ethylpentylone in toxicological samples 
associated with fatal and non-fatal overdoses have been reported in the 
medical and scientific literature, forensic laboratory reports, and 
public health documents. Like schedule I synthetic cathinones, N-
ethylpentylone has caused acute health problems leading to emergency 
department (ED) admissions, violent behaviors causing harm to self or 
others, and/or death. Adverse health effects associated with the abuse 
of N-ethylpentylone include a number of stimulant-like adverse health

[[Page 27522]]

effects such as diaphoresis, insomnia, mydriasis, hyperthermia, 
vomiting, agitation, disorientation, paranoia, abdominal pain, cardiac 
arrest, respiratory failure, and coma. In addition, N-ethylpentylone 
has been involved in deaths of many individuals. The DEA is aware of 
approximately 151 overdose deaths involving N-ethylpentylone abuse 
reported in the United States between 2014 and 2018. Thus, the abuse of 
N-ethylpentylone, like that of the abuse of schedule I synthetic 
cathinones and stimulant drugs, poses significant adverse health risks. 
Furthermore, because abusers of synthetic cathinones obtain these 
substances through unregulated sources, the identity, purity, and 
quantity are uncertain and inconsistent. These unknown factors pose an 
additional risk for significant adverse health effects to the end user.
    Based on information received by the DEA, the misuse and abuse of 
N-ethylpentylone has led to, at least, the same qualitative public 
health risks as schedule I synthetic cathinones, MDMA, and 
methamphetamine. The public health risks attendant to the abuse of 
synthetic cathinones, including N-ethylpentylone, are well established 
and have resulted in large numbers of ED visits and fatal overdoses.

Finding of Necessity of Schedule I Placement To Avoid an Imminent 
Hazard to the Public Safety

    In accordance with 21 U.S.C. 811(h)(3), based on the available data 
and information, summarized above, the uncontrolled manufacture, 
distribution, reverse distribution, importation, exportation, conduct 
of research and chemical analysis, possession, and/or abuse of N-
ethylpentylone resulting from the lack of control of this substance 
poses an imminent hazard to the public safety. The DEA is not aware of 
any currently accepted medical uses for this substance in the United 
States. A substance meeting the statutory requirements for temporary 
scheduling, 21 U.S.C. 811(h)(1), may only be placed in schedule I. 
Substances in schedule I are those that have a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. Available data and information for N-ethylpentylone 
indicate that this substance has a high potential for abuse, no 
currently accepted medical use in treatment in the United States, and a 
lack of accepted safety for use under medical supervision. As required 
by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the 
Administrator, through a letter dated November 22, 2017, notified the 
Acting Assistant Secretary of the DEA's intention to temporarily place 
this substance in schedule I.

Conclusion

    This notice of intent provides the 30-day notice pursuant to 
section 201(h) of the CSA, 21 U.S.C. 811(h), of DEA's intent to issue a 
temporary scheduling order. In accordance with the provisions of 
section 201(h) of the CSA, 21 U.S.C. 811(h), the Acting Administrator 
considered available data and information, herein set forth the grounds 
for his determination that it is necessary to temporarily schedule N-
ethylpentylone in schedule I of the CSA, and finds that placement of N-
ethylpentylone in schedule I of the CSA on a temporary basis is 
necessary in order to avoid an imminent hazard to the public safety.
    The temporary placement of N-ethylpentylone in schedule I of the 
CSA will take effect pursuant to a temporary scheduling order, which 
will not be issued before July 13, 2018. Because the Acting 
Administrator hereby finds that it is necessary to temporarily place N-
ethylpentylone in schedule I to avoid an imminent hazard to the public 
safety, the temporary order scheduling this substance will be effective 
on the date that order is published in the Federal Register, and will 
be in effect for a period of two years, with a possible extension of 
one additional year, pending completion of the regular (permanent) 
scheduling process. 21 U.S.C. 811(h)(1) and (2). It is the intention of 
the Acting Administrator to issue a temporary scheduling order as soon 
as possible after the expiration of 30 days from the date of 
publication of this notice. Upon publication of the temporary order, N-
ethylpentylone will be subject to the regulatory controls and 
administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, reverse distribution, importation, 
exportation, research, conduct of instructional activities and chemical 
analysis, and possession of a schedule I controlled substance.
    The CSA sets forth specific criteria for scheduling a drug or other 
substance. Regular scheduling actions in accordance with 21 U.S.C. 
811(a) are subject to formal rulemaking procedures done ``on the record 
after opportunity for a hearing'' conducted pursuant to the provisions 
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process 
of formal rulemaking affords interested parties with appropriate 
process and the government with any additional relevant information 
needed to make a determination. Final decisions that conclude the 
regular scheduling process of formal rulemaking are subject to judicial 
review. 21 U.S.C. 877. Temporary scheduling orders are not subject to 
judicial review. 21 U.S.C. 811(h)(6).

Regulatory Matters

    Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a 
temporary scheduling action where such action is necessary to avoid an 
imminent hazard to the public safety. As provided in this subsection, 
the Attorney General may, by order, schedule a substance in schedule I 
on a temporary basis. Such an order may not be issued before the 
expiration of 30 days from (1) the publication of a notice in the 
Federal Register of the intention to issue such order and the grounds 
upon which such order is to be issued, and (2) the date that notice of 
the proposed temporary scheduling order is transmitted to the Assistant 
Secretary of HHS. 21 U.S.C. 811(h)(1).
    Inasmuch as section 201(h) of the CSA directs that temporary 
scheduling actions be issued by order and sets forth the procedures by 
which such orders are to be issued, the DEA believes that the notice 
and comment requirements of section 553 of the Administrative Procedure 
Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the 
alternative, even assuming that this notice of intent might be subject 
to section 553 of the APA, the Administrator finds that there is good 
cause to forgo the notice and comment requirements of section 553, as 
any further delays in the process for issuance of temporary scheduling 
orders would be impracticable and contrary to the public interest in 
view of the manifest urgency to avoid an imminent hazard to the public 
safety.
    Although the DEA believes this notice of intent to issue a 
temporary scheduling order is not subject to the notice and comment 
requirements of section 553 of the APA, the DEA notes that in 
accordance with 21 U.S.C. 811(h)(4), the Acting Administrator took into 
consideration comments submitted by the Acting Assistant Secretary in 
response to notice that DEA transmitted to the Acting Assistant 
Secretary pursuant to section 811(h)(4).
    Further, the DEA believes that this temporary scheduling action is 
not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not 
subject to the requirements of the Regulatory Flexibility Act (RFA). 
The requirements for the preparation of an initial regulatory 
flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as 
here, the DEA is not required by section 553

[[Page 27523]]

of the APA or any other law to publish a general notice of proposed 
rulemaking.
    Additionally, this action is not a significant regulatory action as 
defined by Executive Order 12866 (Regulatory Planning and Review), 
section 3(f), and, accordingly, this action has not been reviewed by 
the Office of Management and Budget.
    This action will 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. Therefore, in accordance with Executive Order 
13132 (Federalism) it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.

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, the DEA proposes to amend 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. In Sec.  1308.11, add paragraph (h)(36) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *

(36) N-Ethylpentylone, its optical, positional, and geometric     (7543)
 isomers, salts and salts of isomers (Other names: ephylone, N-
 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-1-pentanone)..........
 

* * * * *

    Dated: June 6, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-12669 Filed 6-12-18; 8:45 am]
 BILLING CODE 4410-09-P