Schedules of Controlled Substances: Placement of N-Ethylpentylone in Schedule I
| Published date | 27 August 2020 |
| Citation | 85 FR 52935 |
| Record Number | 2020-19007 |
| Section | Proposed rules |
| Court | Drug Enforcement Administration |
Federal Register, Volume 85 Issue 167 (Thursday, August 27, 2020)
[Federal Register Volume 85, Number 167 (Thursday, August 27, 2020)]
[Proposed Rules]
[Pages 52935-52940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19007]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-482]
Schedules of Controlled Substances: Placement of N-Ethylpentylone
in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration proposes placing 1-(1,3-
benzodioxol-5-yl)-2-(ethylamino)pentan-1-one (N-ethylpentylone,
ephylone) and its optical, positional, and geometric isomers, salts,
and salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible, in schedule I of the Controlled
Substances Act. If finalized, this action would make permanent the
existing regulatory controls and administrative, civil, and criminal
sanctions applicable to schedule I controlled substances on persons who
handle (manufacture, distribute, reverse distribute, import, export,
engage in research, conduct instructional activities or chemical
analysis, or possess), or propose to handle N-ethylpentylone.
DATES: Comments must be submitted electronically or postmarked on or
before September 28, 2020.
Interested persons may file written comments on this proposal in
accordance with 21 CFR 1308.43(g). Commenters should be aware that the
electronic Federal Docket Management System will not accept comments
after 11:59 p.m. Eastern Time on the last day of the comment period.
Interested persons may file a request for a hearing or waiver of
hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR
1316.45 and/or 1316.47, as applicable. Requests for a hearing and
waivers of an opportunity for a hearing or to participate in a hearing
must be received on or before September 28, 2020.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-482'' on all electronic and written correspondence,
including any attachments.
Electronic comments: The Drug Enforcement Administration
(DEA) encourages that all comments be submitted electronically through
the Federal eRulemaking Portal which provides the ability to type short
comments directly into the comment field on the web page or attach a
file for lengthier comments. Please go to http://www.regulations.gov
and follow the online instructions at that site for submitting
comments. Upon completion of your submission you will receive a Comment
Tracking Number for your comment. Please be aware that submitted
comments are not instantaneously available for public view on
Regulations.gov. If you have received a Comment Tracking Number, your
comment has been successfully submitted and there is no need to
resubmit the same comment.
Paper comments: Paper comments that duplicate the
electronic submission are not necessary. Should you wish to mail a
paper comment, in lieu of an electronic comment, it should be sent via
regular or express mail to: Drug Enforcement Administration, Attn: DEA
Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
Hearing requests: All requests for a hearing and waivers
of participation must be sent to: Drug Enforcement Administration,
Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia
22152. All requests for hearing and waivers of participation should
also be sent to: (1) Drug Enforcement Administration, Attn: Hearing
Clerk/ALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2)
Drug Enforcement Administration, Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia
22152.
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) 362-8209.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. They will, unless reasonable
cause is given, be made available by the Drug Enforcement
Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter. The Freedom of Information Act (FOIA) applies to all
comments received. If you want to submit personal identifying
information (such as your name, address, etc.) as part of your comment,
but do not want it to be made publicly available, you must include the
phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of
your comment. You must also place all of the personal identifying
information you do not want made publicly available in the first
paragraph of your comment and identify what information you want
redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify the
confidential business information to be redacted within the comment.
Comments containing personal identifying information or
confidential business information identified as directed above will be
made publicly available in redacted form. If a comment has so much
confidential business information that it cannot be effectively
redacted, all or part of that comment may not be made publicly
available. Comments posted to http://www.regulations.gov may include
any personal identifying information (such as name, address, and phone
number) included in the text of your electronic submission that is not
identified as directed above as confidential.
An electronic copy of this document and supplemental information to
this
[[Page 52936]]
proposed rule are available at http://www.regulations.gov for easy
reference.
Request for Hearing or Waiver of Participation in Hearing
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the Administrative Procedure
Act, 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316,
subpart D. Interested persons may file requests for hearing or notices
of intent to participate in a hearing in conformity with the
requirements of 21 CFR 1308.44(a) or (b), and include a statement of
interest in the proceeding and the objections or issues, if any,
concerning which the person desires to be heard. Any interested person
may file a waiver of an opportunity for a hearing or to participate in
a hearing together with a written statement regarding the interested
person's position on the matters of fact and law involved in any
hearing as set forth in 21 CFR 1308.44(c).
All requests for a hearing and waivers of participation must be
sent to DEA using the address information provided above.
Legal Authority
The Controlled Substances Act (CSA) provides that proceedings for
the issuance, amendment, or repeal of the scheduling of any drug or
other substance may be initiated by the Attorney General (1) on his own
motion; (2) at the request of the Secretary of the Department of Health
and Human Services (HHS); \1\ or (3) on the petition of any interested
party. 21 U.S.C. 811(a). This proposed action is supported by a
recommendation from the Assistant Secretary for Health of the HHS
(Assistant Secretary) and an evaluation of all other relevant data by
DEA. If finalized, this action would make permanent \2\ the imposition
of regulatory controls and administrative, civil, and criminal
sanctions of schedule I controlled substances on any person who handles
or proposes to handle N-ethylpentylone.
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\1\ As discussed in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), FDA acts as the lead agency within 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 HHS has delegated to the Assistant Secretary for Health
of HHS the authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.
\2\ N-ethylpentylone is currently subject to schedule I controls
on a temporary basis, pursuant to a temporary scheduling order
issued by DEA under authority of 21 U.S.C. 811(h). 83 FR 44474, Aug.
31, 2018.
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Background
On August 31, 2018, DEA published an order in the Federal Register
amending 21 CFR 1308.11(h) to temporarily place 1-(1,3-benzodioxol-5-
yl)-2-(ethylamino)pentan-1-one (N-ethylpentylone, ephylone) in schedule
I of the CSA pursuant to the temporary scheduling provisions of 21
U.S.C. 811(h). 83 FR 44474. That temporary scheduling order was
effective on the date of publication, and was based on findings by the
former Acting Administrator of DEA that the temporary scheduling of
this synthetic cathinone was necessary to avoid an imminent hazard to
the public safety pursuant to section 811(h)(1). Section 811(h)(2)
provides that the temporary control of this substance expire two years
from the effective date of the scheduling order, which was August 31,
2020. However, this same provision also provides that, during the
pendency of proceedings under 21 U.S.C. 811(a)(1) for the permanent
scheduling of the substance, the temporary scheduling of that substance
can be extended for up to one year. Proceedings for the scheduling of a
substance under 21 U.S.C. 811(a) may be initiated by the Attorney
General (delegated to the Administrator of DEA pursuant to 28 CFR
0.100) on his own motion, at the request of the Secretary of HHS,\3\ or
on the petition of any interested party. An extension of the existing
temporary order is being ordered by the Acting Administrator of DEA
(Acting Administrator) in a separate action, and is being
simultaneously published elsewhere in this issue of the Federal
Register.
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\3\ Because the Secretary of HHS has delegated to the Assistant
Secretary for Health the authority to make domestic drug scheduling
recommendations, for purposes of this proposed rulemaking, all
subsequent references to ``Secretary'' have been replaced with
``Assistant Secretary.''
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The Acting Administrator, on his own motion, is initiating
proceedings under 21 U.S.C. 811(a)(1) to permanently schedule N-
ethylpentylone. DEA has gathered and reviewed the available information
regarding the pharmacology, chemistry, trafficking, actual abuse,
pattern of abuse, and the relative potential for abuse for this
synthetic cathinone. On September 25, 2019, the former Acting
Administrator submitted a request to the Assistant Secretary to provide
DEA with a scientific and medical evaluation of available information
and a scheduling recommendation for N-ethylpentylone, in accordance
with 21 U.S.C. 811(b) and (c). Upon evaluating the scientific and
medical evidence, on July 15, 2020, the Assistant Secretary submitted
to the Acting Administrator HHS's scientific and medical evaluations
for this substance. Upon receipt of the scientific and medical
evaluation and scheduling recommendation from HHS, DEA reviewed the
documents and all other relevant data, and conducted its own eight-
factor analysis of the abuse potential of N-ethylpentylone in
accordance with 21 U.S.C. 811(c).
Proposed Determination To Schedule N-Ethylpentylone
As discussed in the background section, the Acting Administrator is
initiating proceedings, pursuant to 21 U.S.C. 811(a)(1), to add N-
ethylpentylone permanently to schedule I. DEA has reviewed the
scientific and medical evaluation and scheduling recommendation,
received from HHS, and all other relevant data and conducted its own
eight-factor analysis of the abuse potential of N-ethylpentylone
pursuant to 21 U.S.C. 811(c). Included below is a brief summary of each
factor as analyzed by HHS and DEA, and as considered by DEA in its
proposed scheduling action. Please note that both the DEA and the HHS
8-Factor analyses and the Assistant Secretary's July 15, 2020, letter
are available in their entirety under the tab ``Supporting Documents''
of the public docket of this rulemaking action at http://www.regulations.gov, under Docket Number ``DEA-482.''
1. The Drug's Actual or Relative Potential for Abuse: Both the DEA
and the HHS 8-factor analyses found that N-ethylpentylone has abuse
potential associated with its abilities to produce psychoactive effects
that are similar to those produced by schedule I synthetic cathinones
such as pentylone, mephedrone, methylone, and 3,4-
methylenedioxypyrovalerone (MDPV) and schedule II stimulants such as
methamphetamine and cocaine that have a high potential for abuse. In
particular, the responses in humans to N-ethylpentylone are stimulant-
like and include paranoia, agitation, palpitations, tachycardia,
hypertension, and hyperthermia.
N-Ethylpentylone has no approved medical uses in the United States
\4\ and has been encountered on the illicit market with adverse
outcomes on the public health and safety. Because this substance is not
an approved drug product, a practitioner may not legally
[[Page 52937]]
prescribe it, and it cannot be dispensed to an individual. The use of
this substance without medical advice leads to the conclusion that this
synthetic cathinone is being abused for its psychoactive properties.
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\4\ There are no legitimate drug channels for N-ethylpentylone
as a marketed drug, but DEA notes that this synthetic cathinone has
been used in scientific research.
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Reports from public health and law enforcement state that this
substance is being abused and taken in amounts sufficient to create a
hazard to an individual's health. This hazard is evidenced by emergency
department admissions and deaths, representing a significant safety
issue for those in the community. Further, from January 2014 through
December 2019 (query date: July 10, 2020), the System to Retrieve
Information from Drug Evidence (STRIDE), STARLiMS, and the National
Forensic Laboratory Information System (NFLIS) databases registered a
total of 20,502 reports by participating DEA, State, local, and other
forensic laboratories, as applicable, pertaining to N-
ethylpentylone.\5\ NFLIS registered more than 19,000 reports from state
and local forensic laboratories identifying this substance in drug-
related exhibits for a period from January 2014 to December 2019 from
46 states. There were no occurrences of N-ethylpentylone reported in
NFLIS for 2013. N-Ethylpentylone was first identified in NFLIS in May
2014. STRIDE/STARLiMS registered more than 700 reports from DEA
forensic laboratories from January 2015 to December 2019. There were no
occurrences of N-ethylpentylone reported in STRIDE/STARLiMS for 2013
and 2014. N-Ethylpentylone was first reported to STRIDE/STARLiMS in
December 2015. Consequently, the data indicate that N-ethylpentylone is
being abused, and it presents safety hazards to the health of
individuals who consume it due to its stimulant properties, making it a
hazard to the safety of the community.
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\5\ STRIDE is a database of drug exhibits sent to DEA
laboratories. Exhibits from the database are from DEA, other federal
agencies, and some local law enforcement agencies. STARLiMS is a
laboratory information management system that systematically
collects results from drug chemistry analyses conducted by DEA
laboratories, and it replaced STRIDE in 2014. NFLIS is a national
drug forensic laboratory reporting system that systematically
collects results from drug chemistry analyses conducted by state and
local forensic laboratories across the country. The NFLIS
participation rate, defined as the percentage of the national drug
caseload represented by laboratories that have joined NFLIS, is over
97 percent. NFLIS includes drug chemistry results from completed
analyses only. NFLIS and STRIDE/STARLiMS databases were queried on
July 10, 2020.
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2. Scientific Evidence of the Drug's Pharmacological Effects, if
Known: As described by HHS, studies show that N-ethylpentylone produces
pharmacological effects that are similar to those produced by schedule
I and II substances such as methamphetamine (II), cocaine (II), MDMA
(I), mephedrone (I), MDPV (I), and methylone (I). Similar to these
schedule I and II substances, N-ethylpentylone binds to monoamine
transporters for dopamine, serotonin, or norepinephrine, and blocks the
uptake of these neurotransmitters at their transporters, but does not
promote the release of these monoamines. Additionally, behavioral
studies in animals demonstrate that N-ethylpentylone produces locomotor
behavior and discriminative stimulus effects that are similar to those
of MDMA, methamphetamine, and cocaine. Overall, these data indicate
that N-ethylpentylone produces pharmacological effects and stimulant-
like behaviors that are similar to those of schedule I substances MDMA,
mephedrone, MDPV, and methylone, as well as schedule II stimulants
methamphetamine and cocaine.
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance: N-Ethylpentylone, like other synthetic cathinones, is
a designer drug of the phenethylamine class and it is structurally
similar to schedule I substances pentylone, mephedrone, methylone,
MDMA, and MDPV, as well as schedule II substance methamphetamine. N-
Ethylpentylone has an ethyl carbon chain (-
CH2CH3) on the nitrogen (N) atom, a propyl group
(-CH2CH2CH3) on the [alpha]-carbon,
and a methylenedioxy group (-OCH2O-) on the phenyl ring.
Pharmacokinetic studies show that N-ethylpentylone is rapidly
absorbed and enters the brain within 20 minutes after intraperitoneal
administration, and at approximately 40 minutes reaches its maximum
concentration. N-Ethylpentylone was found to undergo hydrogenation,
deethylation, demethylation, and hydroxylation in human liver
microsomes resulting in four different metabolites. These four
metabolites of N-ethylpentylone have been identified in blood and oral
fluid specimens in humans.
Neither DEA nor HHS is aware of any currently accepted medical use
for N-ethylpentylone. According to HHS's July 2020 scientific and
medical evaluation and scheduling recommendation, FDA has not approved
a marketing application for a drug product containing N-ethylpentylone
for any therapeutic indication, nor is HHS aware of any reports of
clinical studies or claims of an accepted medical use for N-
ethylpentylone in the United States.
A drug has a ``currently accepted medical use'' if DEA concludes
that it satisfies a five-part test. Specifically, with respect to a
drug that has not been approved by FDA, all of the following must be
demonstrated: The drug's chemistry is known and reproducible; there are
adequate safety studies; there are adequate and well-controlled studies
proving efficacy; the drug is accepted by qualified experts; and the
scientific evidence is widely available. 57 FR 10499 (1992). Based on
this analysis, N-ethylpentylone has no currently accepted medical use
in the United States. Furthermore, DEA has not found any references
regarding clinical testing of N-ethylpentylone in the scientific and
medical literature. Although the chemistry of synthetic cathinones, in
general, is known and has been reproduced, as mentioned above there are
no clinical studies involving N-ethylpentylone. Taken together with the
HHS's conclusion, DEA finds that there is no legitimate medical use for
N-ethylpentylone in the United States.
4. History and Current Pattern of Abuse: As described by DEA and
HHS, N-ethylpentylone is a synthetic cathinone of the phenethylamine
class and it is structurally and pharmacologically similar to schedule
I and II substances such as pentylone (I), mephedrone (I), methylone
(I), MDPV (I), methamphetamine (II), MDMA (I). Thus, it is 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
[[Page 52938]]
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 N-ethylpentylone is a significant concern.
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's
Eight 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.\6\ In 2015, NFLIS registered 6 reports from 4 states
regarding N-ethylpentylone. However, in 2016, there were 2,252 reports
from 40 states and, in 2017, there were 6,242 reports from 44 states
related to this substance registered in NFLIS. N-Ethylpentylone
represented 61 percent of all synthetic cathinones encountered by local
law enforcement agencies and reported to NFLIS in 2017. In 2018, there
were 9,680 reports from 41 states related to this substance registered
in NFLIS, and in 2019, there were 1,598 reports from 25 states. At its
peak in 2018, N-ethylpentylone represented 79 percent of all synthetic
cathinones encountered by local law enforcement agencies and reported
to NFLIS. Overall, from January 2014 to December 2019, NFLIS registered
19,779 reports from state and local forensic laboratories identifying
this substance in drug-related exhibits from 46 states. STRIDE/STARLiMS
registered more than 700 reports from DEA forensic laboratories during
January 2015 to December 2019. There were no occurrences of N-
ethylpentylone reported to STRIDE/STARLiMS for 2014. Concerns over the
continuing abuse of synthetic cathinones have led to the control of
many synthetic cathinones.
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\6\ NFLIS and STRIDE/STARLiMS databases were queried on July 10,
2020.
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6. What, if Any, Risk There Is to the Public Health: HHS reported
that the public health risks of N-ethylpentylone result from its
ability to induce stimulant-like responses, which may lead to adverse
events that include cognitive impairment and even death. Adverse health
effects associated with the abuse of N-ethylpentylone include a number
of stimulant-like adverse health 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. DEA is aware of approximately 154 overdose deaths
involving N-ethylpentylone abuse reported in the United States between
2014 and 2018. Some of these deaths occurred in Alabama, Maryland, and
Florida. Furthermore, the identification of N-ethylpentylone in
toxicological samples associated with fatal and non-fatal overdoses as
reported in the medical and scientific literature, forensic laboratory
reports, and public health documents confirms these adverse effects of
N-ethylpentylone. Like schedule I synthetic cathinones, N-
ethylpentylone has caused acute health problems leading to emergency
department admissions, violent behaviors causing harm to self or
others, and/or death. Thus, the abuse of N-ethylpentylone, like that of
the abuse of schedule I synthetic cathinones and stimulant drugs, poses
significant adverse health risks including death.
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 DEA, the abuse of N-ethylpentylone
has led to, at least, the same qualitative public health risks as
schedule I synthetic cathinones and MDMA, and schedule II
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 emergency department visits and
fatal overdoses.
7. Its Psychic or Physiological Dependence Liability: According to
HHS, the psychic or physiological dependence liability of N-
ethylpentylone is demonstrated by its positive abuse-related studies in
animals and reported stimulant effects in humans. The results from two
behavioral studies (drug discrimination and locomotor studies)
demonstrate that N-ethylpentylone produced behavioral effects that are
similar to those of substances with stimulant effects such as the
schedule I cathinones pentylone and MDPV. Furthermore, N-ethylpentylone
has been reported to be abused for its stimulant properties. In
addition, DEA notes that because N-ethylpentylone shares
pharmacological properties with substances that have stimulant
properties, it is probable that N-ethylpentylone has a dependence
profile similar to these substances which are known to cause substance
dependence.
In summary, data suggests that N-ethylpentylone produces behavioral
effects in animals and humans that are similar to those of schedule I
and II stimulants. Although there are no clinical studies evaluating
dependence liabilities specific for N-ethylpentylone, the
pharmacological profile of this substance strongly suggests that it
possesses dependence liabilities that are qualitatively similar to
schedule I or II substances such as pentylone (I), MDMA (I),
methamphetamine (II), and cocaine (II).
8. Whether the Substance is an Immediate Precursor of a Substance
Already Controlled Under the CSA: N-Ethylpentylone is not an immediate
precursor of any controlled substance under the CSA as defined by 21
U.S.C 802(23).
Conclusion: After considering the scientific and medical evaluation
conducted by HHS, HHS's scheduling recommendation, and DEA's own eight-
factor analysis, DEA finds that the facts and all relevant data
constitute substantial evidence of the potential for abuse of N-
ethylpentylone. As such, DEA hereby proposes to permanently schedule N-
ethylpentylone as a controlled substance under the CSA.
Proposed Determination of Appropriate SSchedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also outlines the findings
required to place a drug or other substance in any particular schedule.
21 U.S.C. 812(b). After consideration of the analysis and
recommendation of the Assistant Secretary for HHS and review of all
other available data, the Acting
[[Page 52939]]
Administrator of DEA, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds
that:
1. N-Ethylpentylone has a high potential for abuse;
2. N-Ethylpentylone has no currently accepted medical use in
treatment in the United States; and
3. There is a lack of accepted safety for use of N-ethylpentylone
under medical supervision.
Based on these findings, the Acting Administrator of DEA concludes
that 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)pentan-1-one (N-
ethylpentylone, ephylone) including its salts, isomers, and salts of
isomers, whenever the existence of such salts, isomers, and salts of
isomers is possible, warrants continued control in schedule I of the
CSA. 21 U.S.C. 812(b)(1).
Requirements for Handling N-Ethylpentylone
If this rule is finalized as proposed, N-ethylpentylone would
continue \7\ to be subject to the CSA's schedule I regulatory controls
and administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, reverse distribution, importation,
exportation, engagement in research, and conduct of instructional
activities or chemical analysis with, and possession of schedule I
controlled substances including the following:
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\7\ N-Ethylpentylone is currently subject to schedule I controls
on a temporary basis, pursuant to the temporary scheduling order
issued by DEA under the authority of 21 U.S.C. 811(h). 83 FR 44474,
August 31, 2018. An order extending the temporary scheduling of N-
ethylpentylone for one year is published elsewhere in this issue of
the Federal Register, on the same day as this notice of proposed
rulemaking.
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1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses) N-
ethylpentylone, or who desires to handle N-ethylpentylone, is required
to be registered with DEA to conduct such activities pursuant to 21
U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301
and 1312.
2. Security. N-Ethylpentylone is subject to schedule I security
requirements and must be handled and stored pursuant to 21 U.S.C. 821,
823, 871(b), and in accordance with 21 CFR 1301.71-1301.93. Non-
practitioners handling N-ethylpentylone must also comply with the
employee screening requirements of 21 CFR 1301.90-1301.93.
3. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of N-ethylpentylone must be in compliance with 21
U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.
4. Quota. Only registered manufacturers are permitted to
manufacture N-ethylpentylone in accordance with a quota assigned
pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
5. Inventory. Any person registered with DEA to handle N-
ethylpentylone must have an initial inventory of all stocks of
controlled substances (including N-ethylpentylone) on hand on the date
the registrant first engages in the handling of controlled substances
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
After the initial inventory, every DEA registrant must take an
inventory of all controlled substances (including N-ethylpentylone) on
hand every two years, pursuant to 21 U.S.C. 827 and 958, and in
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records and Reports. Every DEA registrant is required to
maintain records and submit reports with respect to N-ethylpentylone
pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR
parts 1304 and 1312.
7. Order Forms. Every DEA registrant who distributes N-
ethylpentylone is required to comply with the order form requirements,
pursuant to 21 U.S.C. 828 and 21 CFR part 1305.
8. Importation and Exportation. All importation and exportation of
N-ethylpentylone must be in compliance with 21 U.S.C. 952, 953, 957,
and 958, and in accordance with 21 CFR part 1312.
9. Liability. Any activity involving N-ethylpentylone not
authorized by, or in violation of the CSA or its implementing
regulations is unlawful, and could subject the person to
administrative, civil, and/or criminal sanctions.
Regulatory Analyses
Executive Orders 12866, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs
In accordance with 21 U.S.C. 811(a), this proposed scheduling
action is subject to formal rulemaking procedures performed ``on the
record after opportunity for a hearing,'' which are conducted pursuant
to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the
criteria for scheduling a drug or other substance. Such actions are
exempt from review by the Office of Management and Budget (OMB)
pursuant to section 3(d)(1) of Executive Order 12866 and the principles
reaffirmed in Executive Order (E.O.) 13563.
This proposed rule does not meet the definition of an E.O. 13771
regulatory action, and the repeal and cost offset requirements of E.O.
13771 have not been triggered. OMB has previously determined that
formal rulemaking actions concerning the scheduling of controlled
substances, such as this rule, are not significant regulatory actions
under Section 3(f) of E.O. 12866.
Executive Order 12988, Civil Justice Reform
This proposed 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, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not have federalism implications
warranting the application of E.O. 13132. The proposed rule does not
have substantial direct effects on the States, on the relationship
between the national government and the States, or the distribution of
power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed 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 Acting Administrator, in accordance with the Regulatory
Flexibility Act (RFA), 5 U.S.C. 601-602, has reviewed this proposed
rule and by approving it certifies that it will not have a significant
economic impact on a substantial number of small entities. On August
31, 2018, DEA published an order to temporarily place N-ethylpentylone
in schedule I of the CSA pursuant to the temporary scheduling
provisions of 21 U.S.C. 811(h). DEA estimates that all entities
handling or planning to handle this substance have already established
and implemented the systems and processes required to handle N-
ethylpentylone. There are
[[Page 52940]]
currently 20 unique registrations authorized to handle N-ethylpentylone
specifically, as well as a number of registered analytical labs that
are authorized to handle schedule I controlled substances generally.
From review of entity names, DEA estimates these 20 registrations
represent 16 entities. Some of these entities are likely to be small
entities. However, since DEA does not have information of registrant
size and the majority of DEA registrants are small entities or are
employed by small entities, DEA estimates a maximum of 16 entities are
small entities. Therefore, DEA conservatively estimates as many as 16
small entities are affected by this proposed rule.
A review of the 20 registrations indicates that all entities that
currently handle N-ethylpentylone also handle other schedule I
controlled substances, and thus they have established and implemented
(or maintain) the systems and processes required to handle N-
ethylpentylone as a schedule I substance. Therefore, DEA anticipates
that this proposed rule will impose minimal or no economic impact on
any affected entities, and, thus, will not have a significant economic
impact on any of the 16 affected small entities. Therefore, DEA has
concluded that this proposed rule will not have a significant effect on
a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined and certifies 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.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information 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.
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 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 (d)(86) and remove and reserve
paragraph (h)(36).
The addition reads as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(86) N-Ethylpentylone (Other names: ephylone, 1-(1,3- 7543
benzodioxol-5-yl)-2-(ethylamino)pentan-1-one)...............
* * * * *
Dated: August 24, 2020.
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-19007 Filed 8-26-20; 8:45 am]
BILLING CODE 4410-09-P
