Designation of 4-Piperidone as a List I Chemical, 21902-21910 [2023-07538]
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21902
Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations
Figure 2 to the Introductory Text of
Paragraph (g)(2)—AMM Task for the Pack
Discharge and Ram-Air Supply Ducts
(i) For airplanes that have accumulated less
than 17,600 flight hours since the last
detailed inspection of the pack discharge and
ram air supply ducts was performed as
specified in AMM Task 21–51–00–220–801–
A01, and for airplanes that have accumulated
less than 17,600 flight hours since the date
of issuance of the original airworthiness
certificate or original export certificate of
airworthiness: Within 90 days after the
effective date of this AD, or before
accumulating 17,600 total flight hours,
whichever occurs later.
(ii) For airplanes that have accumulated
17,600 flight hours or more since the last
detailed inspection of the pack discharge and
ram air supply ducts as specified in AMM
Task 21–51–00–220–801–A01, and for
airplanes that have accumulated 17,600 flight
hours or more since the date of issuance of
the original airworthiness certificate or
original export certificate of airworthiness,
and for which no detailed inspection of the
pack discharge and ram air supply ducts has
been performed: Within 90 days after the
effective date of this AD.
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(h) No Alternative Actions or Intervals
After the existing maintenance or
inspection program has been revised as
required by paragraph (g) of this AD, no
alternative actions (e.g., inspections) or
intervals may be used unless the actions and
intervals are approved as an alternative
method of compliance (AMOC) in
accordance with the procedures specified in
paragraph (i)(1) of this AD.
(i) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, New York ACO
Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your
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request to your principal inspector or
responsible Flight Standards Office, as
appropriate. If sending information directly
to the manager of the certification office,
send it to ATTN: Program Manager,
Continuing Operational Safety, FAA, New
York ACO Branch, 1600 Stewart Avenue,
Suite 410, Westbury, NY 11590; telephone
516–228–7300. Before using any approved
AMOC, notify your appropriate principal
inspector, or lacking a principal inspector,
the manager of the responsible Flight
Standards Office.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain instructions
from a manufacturer, the instructions must
be accomplished using a method approved
by the Manager, New York ACO Branch,
FAA; or Transport Canada; or MHI RJ
Aviation ULC’s Transport Canada Design
Approval Organization (DAO). If approved by
the DAO, the approval must include the
DAO-authorized signature.
(j) Additional Information
(1) Refer to Transport Canada AD CF–
2021–38R1, dated May 25, 2022, for related
information. This Transport Canada AD may
be found in the AD docket at regulations.gov
under Docket No. FAA–2022–0679.
(2) For more information about this AD,
contact Chirayu A. Gupta, Aerospace
Engineer, Airframe and Propulsion Section,
FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590;
telephone 516–228–7300; email 9-avs-nyacocos@faa.gov.
(k) Material Incorporated by Reference
None.
Issued on April 6, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2023–07588 Filed 4–11–23; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA–951]
Designation of 4-Piperidone as a List I
Chemical
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:
The Drug Enforcement
Administration (DEA) is finalizing the
control of 4-piperidone, its acetals, its
amides, its carbamates, its salts, and
salts of its acetals, its amides, and its
carbamates, and any combination
thereof, whenever the existence of such
is possible, as a list I chemical under the
Controlled Substances Act. DEA
proposed control of 4-piperidone due to
its use in clandestine laboratories to
illicitly manufacture the schedule II
controlled substance fentanyl. This
rulemaking finalizes the control of 4piperidone as a list I chemical.
DATES: This rulemaking is effective on
May 12, 2023. Persons seeking
registration must apply on or before
May 12, 2023, to continue their business
pending final action by DEA on their
application.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Telephone: (571) 362–
3249.
SUPPLEMENTARY INFORMATION: The Drug
Enforcement Administration (DEA) is
SUMMARY:
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Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations
extremely concerned with the recent
increase in the illicit manufacture and
distribution of fentanyl. Therefore, on
September 22, 2022, DEA published a
Notice of Proposed Rulemaking (NPRM)
to control the precursor chemical 4piperidone as a list I chemical.1 This
rulemaking finalizes that NPRM.
This action subjects handlers of 4piperidone to the chemical regulatory
provisions of the Controlled Substances
Act (CSA) and its implementing
regulations. This rulemaking does not
establish a threshold for domestic and
international transactions of 4piperidone. As such, all transactions
involving 4-piperidone, regardless of
size, shall be regulated and are subject
to control under the CSA. In addition,
chemical mixtures containing 4piperidone are not exempt from
regulatory requirements at any
concentration. Therefore, all
transactions of chemical mixtures
containing any quantity of 4-piperidone
shall be regulated pursuant to the CSA.
Legal Authority
The CSA gives the Attorney General
the authority to specify, by regulation,
chemicals as list I chemicals.2 The
Attorney General delegated his
authority to designate list I chemicals to
the Administrator of DEA
(Administrator).3 A ‘‘list I chemical’’ is
a chemical that is used in
manufacturing a controlled substance in
violation of subchapter I (Control and
Enforcement) of the CSA and is
important to the manufacture of the
controlled substances.2 The current list
of all list I chemicals is published at 21
CFR 1310.02(a). DEA regulations set
forth the process by which DEA may
add a chemical as a listed chemical. As
set forth in 21 CFR 1310.02(c), the
agency may do so by publishing a final
rule in the Federal Register following a
published notice of proposed
rulemaking with at least 30 days for
public comments.
Background
The clandestine manufacture of
fentanyl remains extremely concerning
as the distribution of illicit fentanyl
continues to drive drug-related overdose
deaths in the United States. Fentanyl is
a synthetic opioid and was first
synthesized in Belgium in the late
1950s. Fentanyl was introduced into
medical practice and is approved for
medical practitioners in the United
States to prescribe lawfully for
anesthesia and analgesia. Yet, due to its
pharmacological effects, fentanyl can
also be used as a substitute for heroin,
oxycodone, and other opioids in opioid
dependent individuals. Therefore,
despite its accepted medical use in
treatment in the United States, the DEA
controls fentanyl as a schedule II
controlled substance due to its high
potential for abuse and dependence.4
The unlawful trafficking of fentanyl in
the United States continues to pose an
imminent hazard to the public safety.
Since 2012, fentanyl has shown a
21903
dramatic increase in the illicit drug
supply as a single substance, in
mixtures with other illicit drugs (i.e.,
heroin, cocaine, and
methamphetamine), or in forms that
mimic pharmaceutical preparations
including prescription opiates and
benzodiazepines.5
DEA has noted a significant increase
in overdoses and overdose fatalities
from fentanyl in the United States in
recent years. According to the Centers
for Disease Control and Prevention
(CDC), opioids, mainly synthetic
opioids (including fentanyl), are
predominantly responsible for drug
overdose deaths in recent years.
According to CDC data, drug-induced
overdose deaths involving synthetic
opioids (excluding methadone) in the
United States increased from 36,359 in
2019 to 56,516 in 2020 to 57,802 in 2021
(provisional).6 Of the drug overdose
death data (106,854) predicted for the
12-month period ending November
2021, synthetic opioids were involved
in about 65.9 percent of all druginduced overdose deaths.7 The increase
in overdose fatalities involving
synthetic opioids coincides with a
dramatic increase in law enforcement
encounters of fentanyl. According to the
National Forensic Laboratory
Information System (NFLIS-Drug),8
reports from forensic laboratories of
drug items containing fentanyl
increased dramatically since 2014, as
shown in Table 1.
TABLE 1—ANNUAL REPORTS OF FENTANYL IDENTIFIED IN DRUG ENCOUNTERS
Year ......................................................................................
Reports .................................................................................
Role of 4-Piperidone in the Synthesis of
Fentanyl
Fentanyl is not a naturally occurring
substance. As such, the manufacture of
fentanyl requires it to be produced
through synthetic organic chemistry.
Synthetic organic chemistry is the
process in which a new organic
molecule is created through a series of
chemical reactions, which involve
1 87
FR 57852.
U.S.C. 802(34).
3 28 CFR 0.100(b).
4 21 U.S.C. 812(c) Schedule II(b)(6) and 21 CFR
1308.12(c).
5 United Nations Office on Drugs and Crime,
Global SMART Update Volume 17, March 2017.
https://www.unodc.org/documents/scientific/
Global_SMART_Update_17_web.pdf.
6 Centers for Disease Control and Prevention,
National Center for Health Statistics. National Vital
Statistics System, Provisional Mortality on CDC
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2 21
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2014
5,535
2015
15,456
2016
37,142
2017
61,604
2018
89,764
2019
107,080
2020
115,762
precursor chemicals. Through chemical
reactions, the chemical structures of
precursor chemicals are modified in a
desired fashion. These chemical
reaction sequences, also known as
synthetic pathways, are designed to
create a desired substance. Several
synthetic pathways to fentanyl have
been identified in clandestine laboratory
settings; these include the original
‘‘Janssen method,’’ the ‘‘Siegfried
method,’’ and the ‘‘Gupta method.’’ In
response to the illicit manufacture of
fentanyl using these methods, DEA
controlled N-phenethyl-4-piperidone
(NPP),9 N-(1-benzylpiperidin-4-yl)-Nphenylpropionamide (benzylfentanyl)
and N-phenylpiperidin-4-amine (4anilinopiperidine) 10 as list I chemicals,
and 4-anilino-N-phenethylpiperidine
WONDER Online Database. Data are from the final
Multiple Cause of Death Files, 2018–2020, and from
provisional data for years 2021–2022, as compiled
from data provided by the 57 vital statistics
jurisdictions through the Vital Statistics
Cooperative Program. Accessed at https://
wonder.cdc.gov/mcd-icd10-provisional.html on
May 5, 2022.
7 Ahmad FB, Rossen LM, Sutton P. Provisional
drug overdose death counts. National Center for
Health Statistics. 2021. Accessed at https://
www.cdc.gov/nchs/nvss/vsrr/drug-overdosedata.htm on May 5, 2022.
8 The National Forensic Laboratory Information
System (NFLIS-Drug) is a national forensic
laboratory reporting system that systematically
collects results from drug chemistry analyses
conducted by Federal, State and local forensic
laboratories in the United States. While NFLIS-Drug
data is not direct evidence of abuse, it can lead to
an inference that a drug has been diverted and
abused. See 76 FR 77330, 77332 (December 12,
2011). NFLIS-Drug data was queried on January 13,
2022.
9 72 FR 20039 (April 23, 2007).
10 85 FR 20822 (May 15, 2020).
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(ANPP) 11 and N-phenyl-N-(piperidin-4yl)propionamide (norfentanyl) 12 as
schedule II immediate precursors under
the CSA.
In 2017, the United Nations
Commission on Narcotic Drugs placed
NPP and ANPP in Table I of the
Convention Against Illicit Traffic in
Narcotic Drugs and Psychotropic
Substances of 1988 (1988 Convention)
in response to the international
reintroduction of fentanyl on the illicit
drug market. As such, member states of
the United Nations were required to
regulate these precursor chemicals at
the national level. Importantly, the
People’s Republic of China regulated
NPP and ANPP on February 1, 2018.13
To circumvent these regulations,
illicit fentanyl manufacturers continue
to employ unregulated precursor
chemicals in the illicit synthesis of
fentanyl. Recent law enforcement
information indicates that illicit
fentanyl manufacturers may be utilizing
precursor chemicals that serve as
precursors to those precursor chemicals
already controlled, sometimes referred
to as ‘‘pre-precursors.’’ 4-Piperidone
(also, known as, piperidin-4-one) serves
as a precursor chemical for the
previously controlled list I chemicals
involved in many synthetic routes to
fentanyl; it is used to make NPP,
benzylfentanyl, and 4-anilinopiperidine,
all of which are list I chemicals under
the CSA.14
In addition to the continuous
exploration of viable precursors to
manufacture fentanyl, illicit
manufacturers also employ protecting
group strategies on known fentanyl
precursors. These protecting group
strategies modify the chemical structure
of a known precursor and are
specifically designed to disguise the
known precursor to evade law
enforcement detection or to enhance the
manufacturing process of the controlled
substance the known precursor is used
to make. These modified precursors are
sometimes referred to as ‘‘masked
precursors.’’ For example, 1-boc-4anilinopiperidine (tert-butyl 4(phenylamino) piperidine-1-carboxylate,
1-boc-4–AP), a carbamate of 4anilinopiperidine and a list I chemical,
was identified as a ‘‘masked’’ precursor
chemical used in the illicit manufacture
of fentanyl. Likewise, 1-boc-4piperidone (tert-butyl 4-oxopiperidine1-carboxylate), a carbamate of 411 75
FR 37295 (August 30, 2010).
FR 21320 (May 18, 2020).
13 https://www.dea.gov/press-release/2018/01/05/
china-announces-scheduling-controls-two-fentanylprecursor-chemicals. Accessed March 9, 2022.
14 72 FR 20039 (April 23, 2007) and 85 FR 20822
(April 15, 2020).
12 85
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piperidone, and 4,4-piperidinediol
(piperidine-4,4-diol) have also been
identified as ‘‘masked’’ precursors. As a
carbamate of 4-piperidone, 1-boc-4piperidone is subject to this rulemaking.
Similarly, 4,4-piperidinediol (Chemical
Abstract Service Registry Number (CAS
RN) 73390–11–1 for the free base and
CAS RN 40064–34–4 for the
hydrochloride salt) is 4-piperidone with
the inclusion of one water molecule of
hydration and is known as a hydrate of
4-piperidone. As a hydrate of 4piperidone, 4,4-piperidinediol is also
subject to this rulemaking. These
masked precursors serve both as a role
in attempts to evade law enforcement
detection as well as a strategic synthesis
advantage compared to their
unprotected counterparts (precursors
without protecting groups), namely 4anilinopiperidine and 4-piperidone.
4-Piperidone
The original published synthetic
pathway to fentanyl, known as the
Janssen method, does not involve NPP
or ANPP as precursor chemicals. This
synthetic pathway involves the
important precursors, benzylfentanyl
and norfentanyl. 4-Piperidone serves as
a precursor chemical to benzylfentanyl,
a list I chemical under the CSA,8 which
is converted to norfentanyl, the
schedule II immediate precursor in this
synthetic pathway. Norfentanyl is then
subjected to one simple chemical
reaction to complete the synthesis of
fentanyl. Norfentanyl is controlled in
schedule II of the CSA.10
Like in the Janssen method, 4piperidone also serves as an early-stage
precursor chemical in the Siegfried
method. 4-Piperidone is a precursor to
NPP, a known fentanyl precursor and
list I chemical, in the Siegfried method.
NPP, a list I chemical under the CSA,7
is then converted to ANPP, the schedule
II immediate precursor in this synthetic
pathway. ANPP is then subjected to a
simple one step chemical reaction to
complete the synthesis of fentanyl.
ANPP is controlled as a schedule II
immediate precursor under the CSA.9
In addition to the Janssen and
Siegfried methods, clandestine
manufacturers are using other methods
to synthesize fentanyl, one of which is
known as the Gupta method. 4Piperidone can be used to synthesize 4anilinopiperidine, a list I chemical
under the CSA 8 and key precursor in
the Gupta method. 4-Anilinopiperidine
serves as an alternative precursor
chemical to NPP in the synthesis of
ANPP, albeit through a different
synthetic process. The resulting ANPP
is then used as the immediate precursor
chemical in the illicit manufacture of
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the schedule II controlled substance,
fentanyl.
DEA has determined that 4piperidone is commercially available
from both domestic and foreign
suppliers. DEA is aware of at least 38
domestic suppliers and 19 foreign
suppliers. 4-Piperidone is attractive to
illicit manufacturers due to the lack of
regulations on this chemical, it is
readily available from chemical
suppliers, and it can be easily converted
to known fentanyl precursors, including
NPP, benzylfentanyl, and 4anilinopiperidine.
4-Piperidone and 1-boc-4-piperidone
have been imported and identified in
law enforcement encounters in the
United States. According to law
enforcement information, between
March 2016 and October 2021, there
have been two seizures of 4-piperidone
and one seizure of 1-boc-4-piperidone,
amounting to a total of 357 kilograms
(kg) at ports of entry in the United
States. In addition to these encounters,
a query of DEA’s Laboratory Information
Management System (LIMS) resulted in
a total of three domestic reports of 4piperidone (1) and 1-boc-4-piperidone
(2) from analyses conducted on
submitted drug evidence by DEA
forensic laboratories. 4-Piperidone was
also identified at clandestine
laboratories located in Arizona and
Pennsylvania, which were involved in
the illicit manufacture of fentanyl.
As of May 2019, in addition to
domestic encounters, the International
Narcotics Control Board of the United
Nations reported a total of eight
international transactions of 4piperidone (6) and 1-boc-4-piperidone
(2) through the Precursors Incident
Communication System (PICS).15 These
incidents reported to PICS totaled
approximately 1,900 kg and had
destinations located in North America
and Europe. Along with the incidents
reported to PICS, DEA is aware of a total
of ten additional seizures of 4piperidone (9) and 1-boc-4-piperidone
(1) at international ports of entry since
May 2019, totaling approximately 1,335
kg.
These recent law enforcement
encounters of 4-piperidone coincide
with the placement of NPP and ANPP
in Table I of the 1988 Convention, the
People’s Republic of China regulating
NPP and ANPP as of February 1, 2018,
and the regulation of benzylfentanyl and
4-anilinopiperidine as list I chemicals
and the designation of norfentanyl as a
15 PICS is a platform that allows Governments to
exchange operational and investigative intelligence
and to generate strategic intelligence on precursors
trafficking. PICS reports were collected up to
December 16, 2021.
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schedule II immediate precursor to
fentanyl in the United States. The
domestic and international encounters
of 4-piperidone at ports of entry and the
identification of 4-piperidone at
domestic fentanyl clandestine
laboratories indicate a change in illicit
fentanyl manufacturing methods in
efforts to evade international controls on
NPP and ANPP and additional controls
on benzylfentanyl, 4-anilinopiperidine,
and norfentanyl in the United States.
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Regulation of 4-Piperidone, Including
its Acetals, its Amides, its Carbamates,
its Salts, and Salts of its Acetals, its
Amides, and its Carbamates, and Any
Combination Thereof, Whenever the
Existence of Such Is Possible, as a List
I Chemical
The CSA, specifically 21 U.S.C.
802(34), and its implementing
regulations at 21 CFR 1310.02(c),
provide the Attorney General with the
authority to specify, by regulation,
additional precursor or essential
chemicals as listed chemicals if they are
used in the manufacture of controlled
substances in violation of the CSA.
Recent law enforcement encounters
indicate 4-piperidone is being used in
the illicit manufacture of the schedule II
controlled substance fentanyl. This rule
regulates 4-piperidone, including its
acetals, its amides, its carbamates, its
salts, and salts of its acetals, its amides,
and its carbamates, and any
combination thereof, whenever the
existence of such is possible, as a list I
chemical because DEA finds that 4piperidone is used in the illicit
manufacture of the controlled substance
fentanyl, and is important to the
manufacture of the controlled substance
fentanyl because it cannot be replaced
by other chemicals in its respective
synthetic pathways which are used in
the illicit manufacture of fentanyl. In
effort to make clear DEA’s intent in the
NPRM published on September 22,
2022 16 that combinations of functional
group definitions are included in the
control of 4-piperidone, DEA is
including, ‘‘and any combination
thereof’’ in the definitions of 4piperidone in this final rule. This
amendment is not a substantive change
from the NPRM; it only clarifies DEA’s
intent of this action.
Comments Received
As part of the NPRM published on
September 22, 2022,17 DEA specifically
solicited comment on any possible
legitimate uses of 4-piperidone
unrelated to fentanyl production
16 87
FR 57852.
17 Id.
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(including industrial uses) in order to
assess the potential commercial impact
of controlling 4-piperidone. DEA had
searched information in the public
domain for legitimate uses of this
chemical and had not documented a
legitimate commercial use for 4piperidone other than as intermediary
chemicals in the production of fentanyl.
DEA sought, however, to document any
unpublicized use(s) and other
proprietary use(s) of 4-piperidone that
are not in the public domain. Therefore,
DEA solicited comment on the uses of
4-piperidone in the legitimate
marketplace.
DEA solicited input from all
potentially affected parties regarding: (1)
The types of legitimate industries using
4-piperidone; (2) the legitimate uses of
4-piperidone, if any; (3) the size of the
domestic market for 4-piperidone; (4)
the number of manufacturers of 4piperidone; (5) the number of
distributors of 4-piperidone; (6) the
level of import and export of 4piperidone; (7) the potential burden
these regulatory controls of 4piperidone may have on any legitimate
commercial activities; (8) the potential
number of individuals/firms that may be
adversely affected by these regulatory
controls (particularly with respect to the
impact on small businesses); and (9) any
other information on the manner of
manufacturing, distribution,
consumption, storage, disposal, and
uses of 4-piperidone by industry and
others. DEA invited all interested
parties to provide any information on
any legitimate uses of 4-piperidone in
industry, commerce, academia, research
and development, or other applications.
DEA sought both quantitative and
qualitative data. DEA did not receive
any responses to these specific
solicitations.
In response to the NPRM, DEA
received three comments. Two
commenters were in support of
controlling 4-piperidone as a list I
chemical. One commenter submitted a
response that was outside the scope of
the action.
Comment: One commenter stated that
designating 4-piperidone as a list I
chemical is in the best interest of the
public due to the rise in synthetic
opioid issues in the United States. The
commenter compared the regulation of
4-piperidone to the regulation of
methamphetamine precursors in the
past, which ultimately led to difficulty
in obtaining methamphetamine
precursor chemicals. The commenter
also stated that consequences, such as
foreign production of drugs, be
considered and that work with partner
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21905
nations to reduce availability of illicit
narcotics.
DEA response: DEA agrees with the
comment in support of controlling 4piperidone as a list I chemical. DEA is
concerned with the abuse of illicitly
manufactured fentanyl in the United
States and believes this rule will help to
control the illicit manufacture of
fentanyl. DEA also agrees that the illicit
manufacture of fentanyl and other drugs
is a global challenge and necessitates
cooperation with international partners.
As a list I chemical, imports and exports
of 4-piperidone will be regulated per 21
CFR part 1313.
Comment: One commenter stated that
controlling 4-piperidone would limit
the unlawful manufacture and
distribution of fentanyl. Controlling 4piperidone will reduce theft, which
leads to the unregulated sale of illicitly
manufactured fentanyl. The control of 4piperidone would lead to a decrease in
overdose deaths.
DEA response: DEA agrees with the
comment in support of controlling 4piperidone as a list I chemical. DEA is
concerned with the abuse of illicitly
manufactured fentanyl in the United
States and believes this rule will help to
control the illicit manufacture of
fentanyl.
Comment: One commenter stated that
the Drug Enforcement Agency [sic] does
not have the constitutional authority to
ban and prosecute American citizens for
selling, obtaining, and using drugs not
involved in interstate commerce. The
commenter further states that the Drug
Enforcement Agency [sic] has ruined the
lives of thousands for possession of a
substance and that possession of a
substance is not a morally justifiable
reason for imprisonment. The
commenter stated that DEA needs to
stop arbitrary regulations and allow
Americans to live freely. The
commenter further states that the
criminalization of drugs has given a
monopoly to drug cartels. Lastly, the
commenter states that drug
consumption would be safer, Americans
would be freer, and cartels would lose
their income stream if companies were
allowed to sell drugs.
DEA response: This comment is
outside the scope of this rule. Congress
has provided, in the CSA, the
mechanism to regulate precursor
chemicals, which is the authority
utilized in this rule.18
Chemical Mixtures of 4-Piperidone
Under this rulemaking, chemical
mixtures containing 4-piperidone are
18 21
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not exempt from regulatory
requirements at any concentration,
unless an application for exemption of
a chemical mixture is submitted by a 4piperidone manufacturer and the
application is reviewed and accepted by
DEA under 21 CFR 1310.13 (Exemption
by Application Process). The control of
chemical mixtures containing any
amount of 4-piperidone is necessary to
prevent the extraction, isolation, and
use of 4-piperidone in the illicit
manufacture fentanyl. This rule
modifies the Table of Concentration
Limits in 21 CFR 1310.12(c) to reflect
the fact that chemical mixtures
containing any amount of 4-piperidone
are subject to the CSA chemical control
provisions.
Exemption by Application Process
DEA has implemented an application
process to exempt mixtures from the
requirements of the CSA and its
implementing regulations.19 Under the
application process, manufacturers may
submit an application for exemption for
those mixtures that do not qualify for
automatic exemption. Exemption status
can be granted if DEA determines that
the mixture is formulated in such a way
that it cannot be easily used in the illicit
production of a controlled substance
and that the listed chemical cannot be
readily recovered.20
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Requirements for Handling List I
Chemicals
This final rule subjects 4-piperidone
to all of the regulatory controls and
administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, importing, and exporting of
list I chemicals. Upon the effective date
of this final rule, persons handling 4piperidone, including regulated
chemical mixtures containing 4piperidone, will be required to comply
with list I chemical regulations,
including the following:
1. Registration. Any person who
manufactures, distributes, imports, or
exports 4-piperidone, including
chemical mixtures containing 4piperidone, or proposes to engage in the
manufacture, distribution, importation,
or exportation of 4-piperidone,
including chemical mixtures containing
4-piperidone, must obtain a registration
pursuant to 21 U.S.C. 822, 823, 957, and
958. Regulations describing registration
for list I chemical handlers are set forth
in 21 CFR part 1309. DEA regulations
require separate registrations for
manufacturing, distributing, importing,
and exporting of list I chemicals.21
Further, a separate registration is
required for each principal place of
business at one general physical
location where list I chemicals are
manufactured, distributed, imported, or
exported by a person. 21 U.S.C.
822(e)(1) and 21 CFR 1309.23(a).
DEA notes that under the CSA,
‘‘warehousemen’’ are not required to
register and may lawfully possess list I
chemicals, if the possession of those
chemicals is in the usual course of
business or employment.22 Under DEA
implementing regulations, the
warehouse in question must receive the
list I chemical from a DEA registrant
and shall only distribute the list I
chemical back to the DEA registrant and
registered location from which it was
received. A warehouse that distributes
list I chemicals to persons other than the
registrant and registered location from
which they were obtained is conducting
distribution activities and is required to
register as such.23
Upon the effective date of this final
rule, any person manufacturing,
distributing, importing, or exporting 4piperidone or a chemical mixture
containing 4-piperidone will become
subject to the registration requirement
under the CSA. DEA recognizes,
however, that it is not possible for
persons who are subject to the
registration requirements to
immediately complete and submit an
application for registration, and for DEA
to immediately issue registrations for
those activities. Therefore, to allow any
continued legitimate commerce in 4piperidone or a chemical mixture
containing 4-piperidone, DEA is
establishing in 21 CFR 1310.09, a
temporary exemption from the
registration requirement for persons
desiring to engage in activities with 4piperidone or a chemical mixture
containing 4-piperidone, provided that
DEA receives a properly completed
application for registration or
application for exemption of a chemical
mixture under 21 CFR 1310.13 on or
before May 12, 2023. The temporary
exemption for such persons will remain
in effect until DEA takes final action on
their application for registration or
application for exemption of a chemical
mixture.
The temporary exemption applies
solely to the registration requirement;
all other chemical control requirements,
including recordkeeping and reporting,
would become effective on the effective
date of this final rule. This is necessary
CFR 1309.21.
U.S.C. 822(c)(2)
23 21 U.S.C. 822(a)(1).
because a delay in regulating these
transactions could result in increased
diversion of chemicals desirable to drug
traffickers.
Additionally, the temporary
exemption for registration does not
suspend applicable Federal criminal
laws relating to 4-piperidone, nor does
it supersede State or local laws or
regulations. All handlers of 4piperidone must comply with
applicable State and local requirements
in addition to the CSA regulatory
controls.
2. Records and Reports. Every DEA
registrant must maintain records and
submit reports with respect to 4piperidone pursuant to 21 U.S.C. 830
and in accordance with 21 CFR part
1310.04 and 1310.05. Pursuant to 21
CFR 1310.04, a record must be kept for
two years after the date of a transaction
involving a listed chemical, provided
the transaction is a regulated
transaction.
Each regulated bulk manufacturer of a
listed chemical must submit
manufacturing, inventory, and use data
on an annual basis. Existing standard
industry reports containing the required
information are acceptable, provided the
information is separate or readily
retrievable from the report.24
The CSA and its implementing
regulations require that each regulated
person must report to DEA any
regulated transaction involving an
extraordinary quantity of a listed
chemical, an uncommon method of
payment or delivery, or any other
circumstance that the regulated person
believes may indicate that the listed
chemical will be used in violation of
subchapter I of the CSA. In addition,
regulated persons must report any
regulated transaction with a person
whose description or other identifying
characteristics DEA has previously
furnished to the regulated person, any
unusual or excessive loss or
disappearance of a listed chemical
under the control of the regulated
person, and any in-transit loss in which
the regulated person is the supplier.25
3. Importation and Exportation. All
importation and exportation of 4piperidone or a chemical mixture
containing 4-piperidone must be done
in compliance with 21 U.S.C. 957, 958,
and 971 and in accordance with 21 CFR
part 1313.
4. Security. All applicants and
registrants must provide effective
controls against theft and diversion of
list I chemicals in accordance with 21
CFR 1309.71–1309.73.
21 21
19 21
CFR 1310.13.
20 21 U.S.C. 802(39)(A)(vi).
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25 21
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CFR 1310.05(d).
U.S.C. 830(b) and 21 CFR 1310.05(a) and (b).
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5. Administrative Inspection. Places,
including factories, warehouses, or
other establishments and conveyances,
where registrants or other regulated
persons may lawfully hold,
manufacture, distribute, or otherwise
dispose of a list I chemical or where
records relating to those activities are
maintained, are controlled premises as
defined in 21 U.S.C. 880(a) and 21 CFR
1316.02(c). The CSA allows for
administrative inspections of these
controlled premises as provided in 21
U.S.C. 880 and 21 CFR part 1316,
subpart A.
6. Liability. Any activity involving 4piperidone not authorized by, or in
violation of, the CSA, would be
unlawful, and would subject the person
to administrative, civil, and/or criminal
action.
Regulatory Analyses
Executive Orders 12866 and 13563,
Regulatory Planning and Review,
Improving and Regulation and
Regulatory Review
This final rulemaking, which adds 4piperidone as a list 1 chemical, was
developed in accordance with the
principles of Executive Orders (E.O.)
12866 and 13563. E.O. 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
if regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health,
and safety effects; distributive impacts;
and equity). E.O. 13563 is supplemental
to and reaffirms the principles,
structures, and definitions governing
regulatory review as established in E.O.
12866.
E.O. 12866 classifies a ‘‘significant
regulatory action,’’ requiring review by
the Office of Management and Budget
(OMB), as any regulatory action that is
likely to result in a rule that may: (1)
have an annual effect on the economy
of $100 million or more or adversely
affect in a material way the economy, a
sector of the economy, productivity,
competition, jobs, the environment,
public health or safety, or State, local,
or tribal governments or communities;
(2) create a serious inconsistency or
otherwise interfere with an action taken
or planned by another agency; (3)
materially alter the budgetary impact of
entitlements, grants, user fees, or loan
programs or the rights and obligations of
recipients thereof; or (4) raise novel
legal or policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the E.O.
DEA has reviewed this rule under the
foregoing principles and has determined
that this rule is not a ‘‘significant
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regulatory action’’ under E.O. 12866.
Accordingly, the Office of Information
and Regulatory Affairs has not reviewed
this rule.
This final rulemaking subjects 4piperidone to all of the regulatory
controls and administrative, civil, and
criminal sanctions applicable to the
manufacture, distribution, importing,
and exporting of list I chemicals. 4Piperidone is a precursor chemical used
in, and is important to, the illicit
manufacture of the schedule II
controlled substance fentanyl. The
distribution of illicitly manufactured
fentanyl has caused an unprecedented
outbreak of thousands of fentanylrelated overdoses in the United States in
recent years.
DEA has searched information in the
public domain for any legitimate uses of
4-piperidone, and has not documented
a use for 4-piperidone other than as an
intermediary chemical in the
production of fentanyl. Based on the
review of import and quota information
for NPP, ANPP, and fentanyl, DEA
believes the vast majority of, if not all,
legitimate pharmaceutical fentanyl is
produced via a synthetic route involving
NPP and ANPP as intermediaries, not 4piperidone. The quantities of NPP
indicated in import data and quantities
of ANPP indicated in import and quota
data generally correspond with the
quantities of legitimate pharmaceutical
fentanyl produced in the United States.
Therefore, DEA concludes the vast
majority of, if not all, 4-piperidone
undergoing chemical transactions is
being used for the manufacturing of
illicit fentanyl. DEA cannot rule out the
possibility that minimal quantities of 4piperidone is being used for the
manufacturing of legitimate
pharmaceutical fentanyl. However, if
there are any quantities of 4-piperidone
used for the manufacturing of legitimate
pharmaceutical fentanyl, the quantities
are believed to be small and
economically insignificant. DEA
requested public comment regarding
this estimate; however, no public
comment was received during the notice
and comment period.
DEA evaluated the costs and benefits
of this action.
Costs
DEA believes the market for 4piperidone for the legitimate
manufacturing of pharmaceutical
fentanyl is minimal. As stated above,
the only use for 4-piperidone of which
DEA is aware is as an intermediary for
the manufacturing of fentanyl. Any
manufacturer, distributor, importer, or
exporter of 4-piperidone for the
production of legitimate pharmaceutical
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21907
fentanyl, if they exist at all, will incur
costs. The primary costs associated with
this rule would be the annual
registration fees for list I chemicals
($3,699 for manufacturers and $1,850
for distributors, importers, and
exporters). However, any manufacturer
that uses 4-piperidone for legitimate
pharmaceutical fentanyl production
would already be registered with DEA
and have all security and other handling
processes in place because of the
controls already in place on fentanyl,
resulting in minimal cost to those
entities. While different forms of
handling the scheduled substance
versus the list I chemical (distribution of
fentanyl vs exporting 4-piperidone)
could require a separate registration for
the different handling of the substances,
if an entity is already registered to
handle, manufacture, import, or export
a scheduled substance, the entity would
not need an additional registration for
the list I chemical, provided it is
handling the list I chemical in the same
manner that it is registered for with the
scheduled substance, or as a coincident
activity permitted by § 1309.21. Even
with the possibility of these additional
registrations, DEA believes that the cost
will be minimal.
DEA has identified 38 domestic
suppliers of 4-piperidone. Only one is
registered to handle list I chemicals, the
remaining 37 are not registered with
DEA to handle list I chemicals. It is
difficult to estimate how much 4piperidone is distributed by these
suppliers. It is common for chemical
distributors to have items in their
catalog while not actually having any
material level of sales. Based on the
review of import and quota information
for NPP, ANPP, and fentanyl, where the
quantities of NPP and ANPP imported
and manufactured generally correspond
with the quantities of fentanyl
produced, DEA believes any quantity of
sales from these distributors for
legitimate pharmaceutical fentanyl
manufacturing is minimal. Suppliers for
the legitimate use of 4-piperidone are
expected to choose the least-cost option,
and stop selling the minimal quantities,
if any, of 4-piperidone, rather than incur
the registration cost. Because DEA
believes the quantities of 4-piperidone
supplied for the legitimate
manufacturing of pharmaceutical
fentanyl are minimal, DEA estimates
that the cost of foregone sales is
minimal; and thus, the cost of this rule
is minimal. DEA requested public
comment regarding this estimate;
however, no public comment was
received during the notice and comment
period.
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This analysis excludes consideration
of any economic impact to those
businesses that facilitate the
manufacturing and distribution of 4piperidone for the manufacturing of
illicit fentanyl. As a law enforcement
organization and as a matter of
principle, DEA believes considering the
economic utility of facilitating the
manufacture of illicit fentanyl would be
improper.
Benefits
Controlling 4-piperidone is expected
to prevent, curtail, and limit the
unlawful manufacture and distribution
of the controlled substance, fentanyl. As
a list I chemical, handling of 4piperidone requires registration with
DEA and various controls and
monitoring as required by the CSA. This
rule is also expected to assist preventing
the possible theft or diversion of 4piperidone from any legitimate firms.
DEA also believes control is necessary
to prevent unscrupulous chemists from
synthesizing 4-piperidone and selling it
(as an unregulated material) through the
internet and other channels, to
individuals who may wish to acquire
unregulated intermediary chemicals for
the purpose of illicitly manufacturing
fentanyl.
In summary, DEA conducted a
qualitative analysis of costs and
benefits. DEA believes this action will
minimize the diversion of 4-piperidone.
DEA believes the market for 4piperidone for the legitimate
manufacturing of pharmaceutical
fentanyl is minimal. Therefore, any
potential cost as a result of this
regulation is minimal.
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, minimize litigation, provide
a clear legal standard for affected
conduct, and promote simplification
and burden reduction.
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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
the distribution of power and
responsibilities among the various
levels of government.
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Executive Order 13175, Consultation
and Coordination With Indian Tribal
Governments
This rule does not have tribal
implications warranting the application
of E.O. 13175. This rule 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 Administrator, in accordance
with the Regulatory Flexibility Act (5
U.S.C. 601–612), has reviewed this rule
and by approving it certifies that it will
not have a significant economic impact
on a substantial number of small
entities. As discussed above, 4piperidone or a chemical mixture
containing 4-piperidone shall be subject
to all of the regulatory controls and
administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, importing, and exporting of
list I chemicals. 4-Piperidone is a
precursor chemical used in, and is
important to, the illicit manufacture of
the schedule II controlled substance
fentanyl. The distribution of illicitly
manufactured fentanyl has caused an
unprecedented outbreak of thousands of
fentanyl-related overdoses in the United
States in recent years. DEA has not
identified any legitimate industrial use
for 4-piperidone other than its role as an
intermediary chemical in the
production of fentanyl. However, DEA
believes the vast majority, if not all, of
legitimate pharmaceutical fentanyl is
produced via a synthetic route involving
NPP and ANPP as intermediaries, not 4piperidone. The review of import and
quota information for fentanyl, ANPP,
and NPP supports this belief. Therefore,
DEA believes the vast majority, if not
all, of 4-piperidone is used for the illicit
manufacturing of fentanyl. The primary
costs associated with this rule are the
annual registration fees ($3,699 for
manufacturers and $1,850 for
distributors, importers, and exporters).
Additionally, any manufacturer that
uses 4-piperidone for legitimate
pharmaceutical fentanyl production
would already be registered with DEA
and have all security and other handling
processes in place, resulting in minimal
cost. DEA has identified 38 domestic
suppliers of 4-piperidone, 37 of which
are not registered with DEA to handle
list I chemicals. All non-registered
domestic suppliers are affected and are
estimated to be small entities (based on
Small Business Administration size
standard for chemical distributors and
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Statistics of U.S. Business data).26 It is
impossible to know how much 4piperidone is distributed by these
suppliers. It is common for chemical
distributors to have items in their
catalog while not actually having any
material level of sales. Based on the
review of import and quota information
for NPP, ANPP, and fentanyl, where the
quantities of NPP and ANPP imported
and manufactured generally correspond
with the quantities of fentanyl
produced, DEA believes any quantity of
sales from these distributors for
legitimate pharmaceutical fentanyl
manufacturing is minimal. Therefore,
DEA estimates the cost of this rule on
any affected small entity is minimal.
DEA did not receive public comment
regarding this estimate. Based on these
factors, DEA projects that this rule will
not result in a significant economic
impact on a substantial number of small
entities.
Unfunded Mandates Reform Act of 1995
On the basis of information contained
in the ‘‘Regulatory Flexibility Act’’
section above, DEA has determined and
certifies pursuant to the Unfunded
Mandates Reform Act of 1995 (UMRA),
2 U.S.C. 1501 et seq., 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 for inflation) in any one year
. . . .’’ Therefore, neither a Small
Government Agency Plan nor any other
action is required under provisions of
UMRA.
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 final rule to both Houses
of Congress and to the Comptroller
General.
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
26 https://www.sba.gov/sites/default/files/201807/NAICS%202017%20Table%20of%20Size%20
Standards.pdf.
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Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations
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.
List of Subjects in 21 CFR Part 1310
Administrative practice and
procedure, Drug traffic control, Exports,
Imports, Reporting and recordkeeping
requirements.
For the reasons set out above, DEA
amends 21 CFR part 1310 as follows:
PART 1310—RECORDS AND
REPORTS OF LISTED CHEMICALS
AND CERTAIN MACHINES;
IMPORTATION AND EXPORTATION OF
CERTAIN MACHINES
1. The authority citation for part 1310
continues to read as follows:
■
Authority: 21 U.S.C. 802, 827(h), 830,
871(b), 890.
2. In § 1310.02, add paragraph (a)(38)
to read as follows:
■
§ 1310.02
*
Substances covered.
*
*
(a) * * *
*
*
(38) 4-piperidone (piperidin-4-one),
its acetals, its amides, its
carbamates, its salts, and salts of
its acetals, its amides, and its
carbamates, and any combination
thereof, whenever the existence
of such is possible.
8330
*
*
*
*
*
■ 3. In § 1310.04:
■ a. Redesignate paragraphs (g)(1)(xvi)
and (xvii) as paragraphs (g)(1)(xvii) and
(xviii), respectively; and
■ b. Add a new paragraph (g)(1)(xvi).
The addition reads as follows:
§ 1310.04
Maintenance of records.
*
*
*
*
*
(g) * * *
(1) * * *
(xvi) 4-piperidone (piperidin-4-one),
its acetals, its amides, its carbamates, its
salts, and salts of its acetals, its amides,
and its carbamates, and any
combination thereof, whenever the
existence of such is possible
*
*
*
*
*
■ 4. In § 1310.09, add paragraph (s) to
read as follows:
§ 1310.09 Temporary exemption from
registration.
*
*
*
*
*
(s)(1) Each person required under 21
U.S.C. 822 and 21 U.S.C. 957 to obtain
a registration to manufacture, distribute,
import, or export regulated 4-piperidone
(piperidin-4-one), its acetals, its amides,
its carbamates, its salts, and salts of its
acetals, its amides, and its carbamates,
and any combination thereof, whenever
the existence of such is possible,
including regulated chemical mixtures
pursuant to § 1310.12, is temporarily
exempted from the registration
requirement, provided that DEA
receives a properly completed
application for registration or
application for exemption for a
chemical mixture containing 4piperidone pursuant to § 1310.13 on or
before May 12, 2023. The exemption
would remain in effect for each person
who has made such application until
the Administration has approved or
denied that application. This exemption
applies only to registration; all other
chemical control requirements set forth
in the Act and parts 1309, 1310, 1313,
and 1316 of this chapter remain in full
force and effect.
(2) Any person who manufactures,
distributes, imports, or exports a
chemical mixture containing 4piperidone (piperidin-4-one), its acetals,
its amides, its carbamates, its salts, and
salts of its acetals, its amides, and its
carbamates, and any combination
thereof, whenever the existence of such
is possible whose application for
exemption is subsequently denied by
DEA must obtain a registration with
DEA. A temporary exemption from the
registration requirement will also be
provided for those persons whose
application for exemption is denied,
provided that DEA receives a properly
completed application for registration
on or before 30 days following the date
of official DEA notification that the
application for exemption has been
denied. The temporary exemption for
such persons will remain in effect until
DEA takes final action on their
registration application.
5. In 1310.12, amend the table in
paragraph (c) by adding in alphabetical
order an entry for ‘‘4-piperidone
(piperidin-4-one), its acetals, its amides,
its carbamates, its salts, and salts of its
acetals, its amides, and its carbamates,
and any combination thereof, whenever
the existence of such is possible’’ to
read as follows:
■
§ 1310.12
*
Exempt chemical mixtures.
*
*
(c) * * *
*
*
TABLE OF CONCENTRATION LIMITS
DEA chemical
code No.
Concentration
Special conditions
*
Not exempt at
any concentration.
*
*
Chemical mixtures containing any
amount of 4-piperidone are not
exempt.
List I Chemicals
*
*
*
*
4-piperidone (piperidin-4-one), its acetals, its amides, its carbamates,
its salts, and salts of its acetals, its amides, and its carbamates, and
any combination thereof, whenever the existence of such is possible.
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*
Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations
*
*
*
Scott Brinks,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2023–07538 Filed 4–11–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF STATE
22 CFR Part 126
[Public Notice: 11862]
RIN 1400–AF55
International Traffic in Arms
Regulations: Expansion of Defense
Articles and Defense Services Eligible
for Transfer Under the Canadian and
Treaty Exemptions
Department of State.
Final rule and conforming
revisions.
AGENCY:
ACTION:
The Department of State is
amending the International Traffic in
Arms Regulations (ITAR) to expand the
types of defense articles that may be
exported and defense services that may
be furnished pursuant to the Treaty
between the Government of the United
States of America and the Government
of Australia Concerning Defense Trade
Cooperation, the Treaty between the
Government of the United States of
America and the Government of the
United Kingdom of Great Britain and
Northern Ireland Concerning Defense
Trade Cooperation, and the Canadian
exemptions of the ITAR. The
Department of State is also making
clarifying amendments and conforming
updates.
DATES: The rule is effective on May 12,
2023.
FOR FURTHER INFORMATION CONTACT: Mr.
Dilan Wickrema, Office of Defense
Trade Controls Policy, Department of
State, telephone (202) 634–4981; email
DDTCCustomerService@state.gov
ATTN: Regulatory Change, ITAR
Supplement No.1 to part 126
Amendments.
SUPPLEMENTARY INFORMATION: The rules
(Public Notice 7828, 77 FR 16591 &
Public Notice 8270, 78 FR 21523),
published on March 21, 2012 and April
11, 2013, respectively, amended the
ITAR to implement the Treaty between
the Government of the United States of
America and the Government of
Australia Concerning Defense Trade
Cooperation (referred to herein as ‘‘the
Australia DTC Treaty’’) (Treaty Doc.
110–10) and the Treaty between the
Government of the United States of
America and the Government of the
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SUMMARY:
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United Kingdom of Great Britain and
Northern Ireland Concerning Defense
Trade Cooperation (referred to herein as
‘‘the UK DTC Treaty’’) (Treaty Doc. 110–
7) (together referred to herein as ‘‘the
Treaty exemptions’’), and identified via
Supplement No. 1 to part 126 the
defense articles that may not be
exported, and defense services that may
not be furnished, through the use of the
Treaty exemptions (ITAR §§ 126.16 and
126.17) and the Canadian exemptions
(ITAR § 126.5).
The Department of State is now
amending Supplement No. 1 to part 126
to expand the types of defense articles
that may be exported, and defense
services that may be furnished, pursuant
to the Treaty exemptions and Canadian
exemptions. The Department of State is
implementing this amendment after a
series of routine consultations with its
interagency and international
counterparts. This amendment is
intended to ensure the Treaty
exemptions and the Canadian
exemptions continue to enhance
operational capabilities,
interoperability, and cooperation
between the armed forces of the United
States and its allies and partners. While
future rulemaking will address other
areas of the chart, this final rule
implements four specific changes to
Supplement No. 1 to part 126.
First, this final rule amends the 25th
entry, identified as USML Category IV
which previously excluded ‘‘[d]efense
articles and services specific to
torpedoes,’’ to exclude only ‘‘defense
articles and services specific to the
warhead or the sonar, guidance, and
control section of torpedoes.’’ Second,
this final rule amends the 105th entry,
identified as USML Category XX(c),
which previously excluded ‘‘[d]efense
articles and services specific to
submarine combat control systems,’’ to
remove mounting racks and cabinets
from that entry.
Third, this final rule amends the 60th
entry, the 66th entry, and explanatory
Note 9 to remove specific Underwater
Acoustic Decoy Countermeasures (ADC)
from Supplement No. 1 and clarify the
note. Fourth, this final rule amends the
28th and 29th entries regarding USML
Category IV(i) manufacturing know-how
and the 67th–70th entries regarding
USML Category XII night vision. The
USML Category IV(i) technical data
entries are amended to reflect the fact
that USML Category IV(h) was
previously updated (79 FR 34) to
describe the specific subassemblies of
other USML Category IV defense articles
that remain ITAR-controlled. Similarly,
the night vision entries are updated to
reflect the fact that first generation
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
image intensification tubes are not
subject to the ITAR, some items
previously controlled in paragraph (c) of
Category XII moved to paragraph (e) in
a prior rulemaking (81 FR 70340), and
to clarify that the technical data and
defense services entry only applies to
paragraph (f) of Category XII.
Regulatory Analysis and Notices
Administrative Procedure Act
The Department of State is of the
opinion that controlling the import and
export of defense articles and services is
a foreign affairs function of the United
States Government and that rules
implementing this function are exempt
from sections 553 (rulemaking) and 554
(adjudications) of the Administrative
Procedure Act (APA), pursuant to 5
U.S.C. 553(a)(1).
Regulatory Flexibility Act
This rule is exempt from the noticeand-comment rulemaking provisions of
5 U.S.C. 553 as a foreign affairs
function. Therefore, it does not require
analysis under the Regulatory
Flexibility Act.
Unfunded Mandates Reform Act of 1995
This rulemaking does not involve a
mandate that will result in the
expenditure by State, local, and Tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
in any year and it will not significantly
or uniquely affect small governments.
Therefore, no actions are deemed
necessary under the provisions of the
Unfunded Mandates Reform Act of
1995.
Executive Orders 12372 and 13132
This rulemaking 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,
is determined that this amendment does
not have sufficient federalism
implications to require consultations or
warrant the preparation of a federalism
summary impact statement. The
regulations implementing Executive
Order 12372 regarding
intergovernmental consultation on
Federal programs and activities do not
apply to this rulemaking.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
E:\FR\FM\12APR1.SGM
12APR1
Agencies
[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Rules and Regulations]
[Pages 21902-21910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07538]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-951]
Designation of 4-Piperidone as a List I Chemical
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is finalizing the
control of 4-piperidone, its acetals, its amides, its carbamates, its
salts, and salts of its acetals, its amides, and its carbamates, and
any combination thereof, whenever the existence of such is possible, as
a list I chemical under the Controlled Substances Act. DEA proposed
control of 4-piperidone due to its use in clandestine laboratories to
illicitly manufacture the schedule II controlled substance fentanyl.
This rulemaking finalizes the control of 4-piperidone as a list I
chemical.
DATES: This rulemaking is effective on May 12, 2023. Persons seeking
registration must apply on or before May 12, 2023, to continue their
business pending final action by DEA on their application.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: The Drug Enforcement Administration (DEA) is
[[Page 21903]]
extremely concerned with the recent increase in the illicit manufacture
and distribution of fentanyl. Therefore, on September 22, 2022, DEA
published a Notice of Proposed Rulemaking (NPRM) to control the
precursor chemical 4-piperidone as a list I chemical.\1\ This
rulemaking finalizes that NPRM.
---------------------------------------------------------------------------
\1\ 87 FR 57852.
---------------------------------------------------------------------------
This action subjects handlers of 4-piperidone to the chemical
regulatory provisions of the Controlled Substances Act (CSA) and its
implementing regulations. This rulemaking does not establish a
threshold for domestic and international transactions of 4-piperidone.
As such, all transactions involving 4-piperidone, regardless of size,
shall be regulated and are subject to control under the CSA. In
addition, chemical mixtures containing 4-piperidone are not exempt from
regulatory requirements at any concentration. Therefore, all
transactions of chemical mixtures containing any quantity of 4-
piperidone shall be regulated pursuant to the CSA.
Legal Authority
The CSA gives the Attorney General the authority to specify, by
regulation, chemicals as list I chemicals.\2\ The Attorney General
delegated his authority to designate list I chemicals to the
Administrator of DEA (Administrator).\3\ A ``list I chemical'' is a
chemical that is used in manufacturing a controlled substance in
violation of subchapter I (Control and Enforcement) of the CSA and is
important to the manufacture of the controlled substances.\2\ The
current list of all list I chemicals is published at 21 CFR 1310.02(a).
DEA regulations set forth the process by which DEA may add a chemical
as a listed chemical. As set forth in 21 CFR 1310.02(c), the agency may
do so by publishing a final rule in the Federal Register following a
published notice of proposed rulemaking with at least 30 days for
public comments.
---------------------------------------------------------------------------
\2\ 21 U.S.C. 802(34).
\3\ 28 CFR 0.100(b).
---------------------------------------------------------------------------
Background
The clandestine manufacture of fentanyl remains extremely
concerning as the distribution of illicit fentanyl continues to drive
drug-related overdose deaths in the United States. Fentanyl is a
synthetic opioid and was first synthesized in Belgium in the late
1950s. Fentanyl was introduced into medical practice and is approved
for medical practitioners in the United States to prescribe lawfully
for anesthesia and analgesia. Yet, due to its pharmacological effects,
fentanyl can also be used as a substitute for heroin, oxycodone, and
other opioids in opioid dependent individuals. Therefore, despite its
accepted medical use in treatment in the United States, the DEA
controls fentanyl as a schedule II controlled substance due to its high
potential for abuse and dependence.\4\
---------------------------------------------------------------------------
\4\ 21 U.S.C. 812(c) Schedule II(b)(6) and 21 CFR 1308.12(c).
---------------------------------------------------------------------------
The unlawful trafficking of fentanyl in the United States continues
to pose an imminent hazard to the public safety. Since 2012, fentanyl
has shown a dramatic increase in the illicit drug supply as a single
substance, in mixtures with other illicit drugs (i.e., heroin, cocaine,
and methamphetamine), or in forms that mimic pharmaceutical
preparations including prescription opiates and benzodiazepines.\5\
---------------------------------------------------------------------------
\5\ United Nations Office on Drugs and Crime, Global SMART
Update Volume 17, March 2017. https://www.unodc.org/documents/scientific/Global_SMART_Update_17_web.pdf.
---------------------------------------------------------------------------
DEA has noted a significant increase in overdoses and overdose
fatalities from fentanyl in the United States in recent years.
According to the Centers for Disease Control and Prevention (CDC),
opioids, mainly synthetic opioids (including fentanyl), are
predominantly responsible for drug overdose deaths in recent years.
According to CDC data, drug-induced overdose deaths involving synthetic
opioids (excluding methadone) in the United States increased from
36,359 in 2019 to 56,516 in 2020 to 57,802 in 2021 (provisional).\6\ Of
the drug overdose death data (106,854) predicted for the 12-month
period ending November 2021, synthetic opioids were involved in about
65.9 percent of all drug-induced overdose deaths.\7\ The increase in
overdose fatalities involving synthetic opioids coincides with a
dramatic increase in law enforcement encounters of fentanyl. According
to the National Forensic Laboratory Information System (NFLIS-Drug),\8\
reports from forensic laboratories of drug items containing fentanyl
increased dramatically since 2014, as shown in Table 1.
---------------------------------------------------------------------------
\6\ Centers for Disease Control and Prevention, National Center
for Health Statistics. National Vital Statistics System, Provisional
Mortality on CDC WONDER Online Database. Data are from the final
Multiple Cause of Death Files, 2018-2020, and from provisional data
for years 2021-2022, as compiled from data provided by the 57 vital
statistics jurisdictions through the Vital Statistics Cooperative
Program. Accessed at https://wonder.cdc.gov/mcd-icd10-provisional.html on May 5, 2022.
\7\ Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose
death counts. National Center for Health Statistics. 2021. Accessed
at https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm on May
5, 2022.
\8\ The National Forensic Laboratory Information System (NFLIS-
Drug) is a national forensic laboratory reporting system that
systematically collects results from drug chemistry analyses
conducted by Federal, State and local forensic laboratories in the
United States. While NFLIS-Drug data is not direct evidence of
abuse, it can lead to an inference that a drug has been diverted and
abused. See 76 FR 77330, 77332 (December 12, 2011). NFLIS-Drug data
was queried on January 13, 2022.
Table 1--Annual Reports of Fentanyl Identified in Drug Encounters
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Year............................... 2014 2015 2016 2017 2018 2019 2020
Reports............................ 5,535 15,456 37,142 61,604 89,764 107,080 115,762
----------------------------------------------------------------------------------------------------------------
Role of 4-Piperidone in the Synthesis of Fentanyl
Fentanyl is not a naturally occurring substance. As such, the
manufacture of fentanyl requires it to be produced through synthetic
organic chemistry. Synthetic organic chemistry is the process in which
a new organic molecule is created through a series of chemical
reactions, which involve precursor chemicals. Through chemical
reactions, the chemical structures of precursor chemicals are modified
in a desired fashion. These chemical reaction sequences, also known as
synthetic pathways, are designed to create a desired substance. Several
synthetic pathways to fentanyl have been identified in clandestine
laboratory settings; these include the original ``Janssen method,'' the
``Siegfried method,'' and the ``Gupta method.'' In response to the
illicit manufacture of fentanyl using these methods, DEA controlled N-
phenethyl-4-piperidone (NPP),\9\ N-(1-benzylpiperidin-4-yl)-N-
phenylpropionamide (benzylfentanyl) and N-phenylpiperidin-4-amine (4-
anilinopiperidine) \10\ as list I chemicals, and 4-anilino-N-
phenethylpiperidine
[[Page 21904]]
(ANPP) \11\ and N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl)
\12\ as schedule II immediate precursors under the CSA.
---------------------------------------------------------------------------
\9\ 72 FR 20039 (April 23, 2007).
\10\ 85 FR 20822 (May 15, 2020).
\11\ 75 FR 37295 (August 30, 2010).
\12\ 85 FR 21320 (May 18, 2020).
---------------------------------------------------------------------------
In 2017, the United Nations Commission on Narcotic Drugs placed NPP
and ANPP in Table I of the Convention Against Illicit Traffic in
Narcotic Drugs and Psychotropic Substances of 1988 (1988 Convention) in
response to the international reintroduction of fentanyl on the illicit
drug market. As such, member states of the United Nations were required
to regulate these precursor chemicals at the national level.
Importantly, the People's Republic of China regulated NPP and ANPP on
February 1, 2018.\13\
---------------------------------------------------------------------------
\13\ https://www.dea.gov/press-release/2018/01/05/china-announces-scheduling-controls-two-fentanyl-precursor-chemicals.
Accessed March 9, 2022.
---------------------------------------------------------------------------
To circumvent these regulations, illicit fentanyl manufacturers
continue to employ unregulated precursor chemicals in the illicit
synthesis of fentanyl. Recent law enforcement information indicates
that illicit fentanyl manufacturers may be utilizing precursor
chemicals that serve as precursors to those precursor chemicals already
controlled, sometimes referred to as ``pre-precursors.'' 4-Piperidone
(also, known as, piperidin-4-one) serves as a precursor chemical for
the previously controlled list I chemicals involved in many synthetic
routes to fentanyl; it is used to make NPP, benzylfentanyl, and 4-
anilinopiperidine, all of which are list I chemicals under the CSA.\14\
---------------------------------------------------------------------------
\14\ 72 FR 20039 (April 23, 2007) and 85 FR 20822 (April 15,
2020).
---------------------------------------------------------------------------
In addition to the continuous exploration of viable precursors to
manufacture fentanyl, illicit manufacturers also employ protecting
group strategies on known fentanyl precursors. These protecting group
strategies modify the chemical structure of a known precursor and are
specifically designed to disguise the known precursor to evade law
enforcement detection or to enhance the manufacturing process of the
controlled substance the known precursor is used to make. These
modified precursors are sometimes referred to as ``masked precursors.''
For example, 1-boc-4-anilinopiperidine (tert-butyl 4-(phenylamino)
piperidine-1-carboxylate, 1-boc-4-AP), a carbamate of 4-
anilinopiperidine and a list I chemical, was identified as a ``masked''
precursor chemical used in the illicit manufacture of fentanyl.
Likewise, 1-boc-4-piperidone (tert-butyl 4-oxopiperidine-1-
carboxylate), a carbamate of 4-piperidone, and 4,4-piperidinediol
(piperidine-4,4-diol) have also been identified as ``masked''
precursors. As a carbamate of 4-piperidone, 1-boc-4-piperidone is
subject to this rulemaking. Similarly, 4,4-piperidinediol (Chemical
Abstract Service Registry Number (CAS RN) 73390-11-1 for the free base
and CAS RN 40064-34-4 for the hydrochloride salt) is 4-piperidone with
the inclusion of one water molecule of hydration and is known as a
hydrate of 4-piperidone. As a hydrate of 4-piperidone, 4,4-
piperidinediol is also subject to this rulemaking. These masked
precursors serve both as a role in attempts to evade law enforcement
detection as well as a strategic synthesis advantage compared to their
unprotected counterparts (precursors without protecting groups), namely
4-anilinopiperidine and 4-piperidone.
4-Piperidone
The original published synthetic pathway to fentanyl, known as the
Janssen method, does not involve NPP or ANPP as precursor chemicals.
This synthetic pathway involves the important precursors,
benzylfentanyl and norfentanyl. 4-Piperidone serves as a precursor
chemical to benzylfentanyl, a list I chemical under the CSA,\8\ which
is converted to norfentanyl, the schedule II immediate precursor in
this synthetic pathway. Norfentanyl is then subjected to one simple
chemical reaction to complete the synthesis of fentanyl. Norfentanyl is
controlled in schedule II of the CSA.\10\
Like in the Janssen method, 4-piperidone also serves as an early-
stage precursor chemical in the Siegfried method. 4-Piperidone is a
precursor to NPP, a known fentanyl precursor and list I chemical, in
the Siegfried method. NPP, a list I chemical under the CSA,\7\ is then
converted to ANPP, the schedule II immediate precursor in this
synthetic pathway. ANPP is then subjected to a simple one step chemical
reaction to complete the synthesis of fentanyl. ANPP is controlled as a
schedule II immediate precursor under the CSA.\9\
In addition to the Janssen and Siegfried methods, clandestine
manufacturers are using other methods to synthesize fentanyl, one of
which is known as the Gupta method. 4-Piperidone can be used to
synthesize 4-anilinopiperidine, a list I chemical under the CSA \8\ and
key precursor in the Gupta method. 4-Anilinopiperidine serves as an
alternative precursor chemical to NPP in the synthesis of ANPP, albeit
through a different synthetic process. The resulting ANPP is then used
as the immediate precursor chemical in the illicit manufacture of the
schedule II controlled substance, fentanyl.
DEA has determined that 4-piperidone is commercially available from
both domestic and foreign suppliers. DEA is aware of at least 38
domestic suppliers and 19 foreign suppliers. 4-Piperidone is attractive
to illicit manufacturers due to the lack of regulations on this
chemical, it is readily available from chemical suppliers, and it can
be easily converted to known fentanyl precursors, including NPP,
benzylfentanyl, and 4-anilinopiperidine.
4-Piperidone and 1-boc-4-piperidone have been imported and
identified in law enforcement encounters in the United States.
According to law enforcement information, between March 2016 and
October 2021, there have been two seizures of 4-piperidone and one
seizure of 1-boc-4-piperidone, amounting to a total of 357 kilograms
(kg) at ports of entry in the United States. In addition to these
encounters, a query of DEA's Laboratory Information Management System
(LIMS) resulted in a total of three domestic reports of 4-piperidone
(1) and 1-boc-4-piperidone (2) from analyses conducted on submitted
drug evidence by DEA forensic laboratories. 4-Piperidone was also
identified at clandestine laboratories located in Arizona and
Pennsylvania, which were involved in the illicit manufacture of
fentanyl.
As of May 2019, in addition to domestic encounters, the
International Narcotics Control Board of the United Nations reported a
total of eight international transactions of 4-piperidone (6) and 1-
boc-4-piperidone (2) through the Precursors Incident Communication
System (PICS).\15\ These incidents reported to PICS totaled
approximately 1,900 kg and had destinations located in North America
and Europe. Along with the incidents reported to PICS, DEA is aware of
a total of ten additional seizures of 4-piperidone (9) and 1-boc-4-
piperidone (1) at international ports of entry since May 2019, totaling
approximately 1,335 kg.
---------------------------------------------------------------------------
\15\ PICS is a platform that allows Governments to exchange
operational and investigative intelligence and to generate strategic
intelligence on precursors trafficking. PICS reports were collected
up to December 16, 2021.
---------------------------------------------------------------------------
These recent law enforcement encounters of 4-piperidone coincide
with the placement of NPP and ANPP in Table I of the 1988 Convention,
the People's Republic of China regulating NPP and ANPP as of February
1, 2018, and the regulation of benzylfentanyl and 4-anilinopiperidine
as list I chemicals and the designation of norfentanyl as a
[[Page 21905]]
schedule II immediate precursor to fentanyl in the United States. The
domestic and international encounters of 4-piperidone at ports of entry
and the identification of 4-piperidone at domestic fentanyl clandestine
laboratories indicate a change in illicit fentanyl manufacturing
methods in efforts to evade international controls on NPP and ANPP and
additional controls on benzylfentanyl, 4-anilinopiperidine, and
norfentanyl in the United States.
Regulation of 4-Piperidone, Including its Acetals, its Amides, its
Carbamates, its Salts, and Salts of its Acetals, its Amides, and its
Carbamates, and Any Combination Thereof, Whenever the Existence of Such
Is Possible, as a List I Chemical
The CSA, specifically 21 U.S.C. 802(34), and its implementing
regulations at 21 CFR 1310.02(c), provide the Attorney General with the
authority to specify, by regulation, additional precursor or essential
chemicals as listed chemicals if they are used in the manufacture of
controlled substances in violation of the CSA. Recent law enforcement
encounters indicate 4-piperidone is being used in the illicit
manufacture of the schedule II controlled substance fentanyl. This rule
regulates 4-piperidone, including its acetals, its amides, its
carbamates, its salts, and salts of its acetals, its amides, and its
carbamates, and any combination thereof, whenever the existence of such
is possible, as a list I chemical because DEA finds that 4-piperidone
is used in the illicit manufacture of the controlled substance
fentanyl, and is important to the manufacture of the controlled
substance fentanyl because it cannot be replaced by other chemicals in
its respective synthetic pathways which are used in the illicit
manufacture of fentanyl. In effort to make clear DEA's intent in the
NPRM published on September 22, 2022 \16\ that combinations of
functional group definitions are included in the control of 4-
piperidone, DEA is including, ``and any combination thereof'' in the
definitions of 4-piperidone in this final rule. This amendment is not a
substantive change from the NPRM; it only clarifies DEA's intent of
this action.
---------------------------------------------------------------------------
\16\ 87 FR 57852.
---------------------------------------------------------------------------
Comments Received
As part of the NPRM published on September 22, 2022,\17\ DEA
specifically solicited comment on any possible legitimate uses of 4-
piperidone unrelated to fentanyl production (including industrial uses)
in order to assess the potential commercial impact of controlling 4-
piperidone. DEA had searched information in the public domain for
legitimate uses of this chemical and had not documented a legitimate
commercial use for 4-piperidone other than as intermediary chemicals in
the production of fentanyl. DEA sought, however, to document any
unpublicized use(s) and other proprietary use(s) of 4-piperidone that
are not in the public domain. Therefore, DEA solicited comment on the
uses of 4-piperidone in the legitimate marketplace.
---------------------------------------------------------------------------
\17\ Id.
---------------------------------------------------------------------------
DEA solicited input from all potentially affected parties
regarding: (1) The types of legitimate industries using 4-piperidone;
(2) the legitimate uses of 4-piperidone, if any; (3) the size of the
domestic market for 4-piperidone; (4) the number of manufacturers of 4-
piperidone; (5) the number of distributors of 4-piperidone; (6) the
level of import and export of 4-piperidone; (7) the potential burden
these regulatory controls of 4-piperidone may have on any legitimate
commercial activities; (8) the potential number of individuals/firms
that may be adversely affected by these regulatory controls
(particularly with respect to the impact on small businesses); and (9)
any other information on the manner of manufacturing, distribution,
consumption, storage, disposal, and uses of 4-piperidone by industry
and others. DEA invited all interested parties to provide any
information on any legitimate uses of 4-piperidone in industry,
commerce, academia, research and development, or other applications.
DEA sought both quantitative and qualitative data. DEA did not receive
any responses to these specific solicitations.
In response to the NPRM, DEA received three comments. Two
commenters were in support of controlling 4-piperidone as a list I
chemical. One commenter submitted a response that was outside the scope
of the action.
Comment: One commenter stated that designating 4-piperidone as a
list I chemical is in the best interest of the public due to the rise
in synthetic opioid issues in the United States. The commenter compared
the regulation of 4-piperidone to the regulation of methamphetamine
precursors in the past, which ultimately led to difficulty in obtaining
methamphetamine precursor chemicals. The commenter also stated that
consequences, such as foreign production of drugs, be considered and
that work with partner nations to reduce availability of illicit
narcotics.
DEA response: DEA agrees with the comment in support of controlling
4-piperidone as a list I chemical. DEA is concerned with the abuse of
illicitly manufactured fentanyl in the United States and believes this
rule will help to control the illicit manufacture of fentanyl. DEA also
agrees that the illicit manufacture of fentanyl and other drugs is a
global challenge and necessitates cooperation with international
partners. As a list I chemical, imports and exports of 4-piperidone
will be regulated per 21 CFR part 1313.
Comment: One commenter stated that controlling 4-piperidone would
limit the unlawful manufacture and distribution of fentanyl.
Controlling 4-piperidone will reduce theft, which leads to the
unregulated sale of illicitly manufactured fentanyl. The control of 4-
piperidone would lead to a decrease in overdose deaths.
DEA response: DEA agrees with the comment in support of controlling
4-piperidone as a list I chemical. DEA is concerned with the abuse of
illicitly manufactured fentanyl in the United States and believes this
rule will help to control the illicit manufacture of fentanyl.
Comment: One commenter stated that the Drug Enforcement Agency
[sic] does not have the constitutional authority to ban and prosecute
American citizens for selling, obtaining, and using drugs not involved
in interstate commerce. The commenter further states that the Drug
Enforcement Agency [sic] has ruined the lives of thousands for
possession of a substance and that possession of a substance is not a
morally justifiable reason for imprisonment. The commenter stated that
DEA needs to stop arbitrary regulations and allow Americans to live
freely. The commenter further states that the criminalization of drugs
has given a monopoly to drug cartels. Lastly, the commenter states that
drug consumption would be safer, Americans would be freer, and cartels
would lose their income stream if companies were allowed to sell drugs.
DEA response: This comment is outside the scope of this rule.
Congress has provided, in the CSA, the mechanism to regulate precursor
chemicals, which is the authority utilized in this rule.\18\
---------------------------------------------------------------------------
\18\ 21 U.S.C. 802(34).
---------------------------------------------------------------------------
Chemical Mixtures of 4-Piperidone
Under this rulemaking, chemical mixtures containing 4-piperidone
are
[[Page 21906]]
not exempt from regulatory requirements at any concentration, unless an
application for exemption of a chemical mixture is submitted by a 4-
piperidone manufacturer and the application is reviewed and accepted by
DEA under 21 CFR 1310.13 (Exemption by Application Process). The
control of chemical mixtures containing any amount of 4-piperidone is
necessary to prevent the extraction, isolation, and use of 4-piperidone
in the illicit manufacture fentanyl. This rule modifies the Table of
Concentration Limits in 21 CFR 1310.12(c) to reflect the fact that
chemical mixtures containing any amount of 4-piperidone are subject to
the CSA chemical control provisions.
Exemption by Application Process
DEA has implemented an application process to exempt mixtures from
the requirements of the CSA and its implementing regulations.\19\ Under
the application process, manufacturers may submit an application for
exemption for those mixtures that do not qualify for automatic
exemption. Exemption status can be granted if DEA determines that the
mixture is formulated in such a way that it cannot be easily used in
the illicit production of a controlled substance and that the listed
chemical cannot be readily recovered.\20\
---------------------------------------------------------------------------
\19\ 21 CFR 1310.13.
\20\ 21 U.S.C. 802(39)(A)(vi).
---------------------------------------------------------------------------
Requirements for Handling List I Chemicals
This final rule subjects 4-piperidone to all of the regulatory
controls and administrative, civil, and criminal sanctions applicable
to the manufacture, distribution, importing, and exporting of list I
chemicals. Upon the effective date of this final rule, persons handling
4-piperidone, including regulated chemical mixtures containing 4-
piperidone, will be required to comply with list I chemical
regulations, including the following:
1. Registration. Any person who manufactures, distributes, imports,
or exports 4-piperidone, including chemical mixtures containing 4-
piperidone, or proposes to engage in the manufacture, distribution,
importation, or exportation of 4-piperidone, including chemical
mixtures containing 4-piperidone, must obtain a registration pursuant
to 21 U.S.C. 822, 823, 957, and 958. Regulations describing
registration for list I chemical handlers are set forth in 21 CFR part
1309. DEA regulations require separate registrations for manufacturing,
distributing, importing, and exporting of list I chemicals.\21\
Further, a separate registration is required for each principal place
of business at one general physical location where list I chemicals are
manufactured, distributed, imported, or exported by a person. 21 U.S.C.
822(e)(1) and 21 CFR 1309.23(a).
---------------------------------------------------------------------------
\21\ 21 CFR 1309.21.
---------------------------------------------------------------------------
DEA notes that under the CSA, ``warehousemen'' are not required to
register and may lawfully possess list I chemicals, if the possession
of those chemicals is in the usual course of business or
employment.\22\ Under DEA implementing regulations, the warehouse in
question must receive the list I chemical from a DEA registrant and
shall only distribute the list I chemical back to the DEA registrant
and registered location from which it was received. A warehouse that
distributes list I chemicals to persons other than the registrant and
registered location from which they were obtained is conducting
distribution activities and is required to register as such.\23\
---------------------------------------------------------------------------
\22\ 21 U.S.C. 822(c)(2)
\23\ 21 U.S.C. 822(a)(1).
---------------------------------------------------------------------------
Upon the effective date of this final rule, any person
manufacturing, distributing, importing, or exporting 4-piperidone or a
chemical mixture containing 4-piperidone will become subject to the
registration requirement under the CSA. DEA recognizes, however, that
it is not possible for persons who are subject to the registration
requirements to immediately complete and submit an application for
registration, and for DEA to immediately issue registrations for those
activities. Therefore, to allow any continued legitimate commerce in 4-
piperidone or a chemical mixture containing 4-piperidone, DEA is
establishing in 21 CFR 1310.09, a temporary exemption from the
registration requirement for persons desiring to engage in activities
with 4-piperidone or a chemical mixture containing 4-piperidone,
provided that DEA receives a properly completed application for
registration or application for exemption of a chemical mixture under
21 CFR 1310.13 on or before May 12, 2023. The temporary exemption for
such persons will remain in effect until DEA takes final action on
their application for registration or application for exemption of a
chemical mixture.
The temporary exemption applies solely to the registration
requirement; all other chemical control requirements, including
recordkeeping and reporting, would become effective on the effective
date of this final rule. This is necessary because a delay in
regulating these transactions could result in increased diversion of
chemicals desirable to drug traffickers.
Additionally, the temporary exemption for registration does not
suspend applicable Federal criminal laws relating to 4-piperidone, nor
does it supersede State or local laws or regulations. All handlers of
4-piperidone must comply with applicable State and local requirements
in addition to the CSA regulatory controls.
2. Records and Reports. Every DEA registrant must maintain records
and submit reports with respect to 4-piperidone pursuant to 21 U.S.C.
830 and in accordance with 21 CFR part 1310.04 and 1310.05. Pursuant to
21 CFR 1310.04, a record must be kept for two years after the date of a
transaction involving a listed chemical, provided the transaction is a
regulated transaction.
Each regulated bulk manufacturer of a listed chemical must submit
manufacturing, inventory, and use data on an annual basis. Existing
standard industry reports containing the required information are
acceptable, provided the information is separate or readily retrievable
from the report.\24\
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\24\ 21 CFR 1310.05(d).
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The CSA and its implementing regulations require that each
regulated person must report to DEA any regulated transaction involving
an extraordinary quantity of a listed chemical, an uncommon method of
payment or delivery, or any other circumstance that the regulated
person believes may indicate that the listed chemical will be used in
violation of subchapter I of the CSA. In addition, regulated persons
must report any regulated transaction with a person whose description
or other identifying characteristics DEA has previously furnished to
the regulated person, any unusual or excessive loss or disappearance of
a listed chemical under the control of the regulated person, and any
in-transit loss in which the regulated person is the supplier.\25\
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\25\ 21 U.S.C. 830(b) and 21 CFR 1310.05(a) and (b).
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3. Importation and Exportation. All importation and exportation of
4-piperidone or a chemical mixture containing 4-piperidone must be done
in compliance with 21 U.S.C. 957, 958, and 971 and in accordance with
21 CFR part 1313.
4. Security. All applicants and registrants must provide effective
controls against theft and diversion of list I chemicals in accordance
with 21 CFR 1309.71-1309.73.
[[Page 21907]]
5. Administrative Inspection. Places, including factories,
warehouses, or other establishments and conveyances, where registrants
or other regulated persons may lawfully hold, manufacture, distribute,
or otherwise dispose of a list I chemical or where records relating to
those activities are maintained, are controlled premises as defined in
21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for
administrative inspections of these controlled premises as provided in
21 U.S.C. 880 and 21 CFR part 1316, subpart A.
6. Liability. Any activity involving 4-piperidone not authorized
by, or in violation of, the CSA, would be unlawful, and would subject
the person to administrative, civil, and/or criminal action.
Regulatory Analyses
Executive Orders 12866 and 13563, Regulatory Planning and Review,
Improving and Regulation and Regulatory Review
This final rulemaking, which adds 4-piperidone as a list 1
chemical, was developed in accordance with the principles of Executive
Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health, and safety effects; distributive impacts; and equity). E.O.
13563 is supplemental to and reaffirms the principles, structures, and
definitions governing regulatory review as established in E.O. 12866.
E.O. 12866 classifies a ``significant regulatory action,''
requiring review by the Office of Management and Budget (OMB), as any
regulatory action that is likely to result in a rule that may: (1) have
an annual effect on the economy of $100 million or more or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities; (2)
create a serious inconsistency or otherwise interfere with an action
taken or planned by another agency; (3) materially alter the budgetary
impact of entitlements, grants, user fees, or loan programs or the
rights and obligations of recipients thereof; or (4) raise novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the E.O.
DEA has reviewed this rule under the foregoing principles and has
determined that this rule is not a ``significant regulatory action''
under E.O. 12866. Accordingly, the Office of Information and Regulatory
Affairs has not reviewed this rule.
This final rulemaking subjects 4-piperidone to all of the
regulatory controls and administrative, civil, and criminal sanctions
applicable to the manufacture, distribution, importing, and exporting
of list I chemicals. 4-Piperidone is a precursor chemical used in, and
is important to, the illicit manufacture of the schedule II controlled
substance fentanyl. The distribution of illicitly manufactured fentanyl
has caused an unprecedented outbreak of thousands of fentanyl-related
overdoses in the United States in recent years.
DEA has searched information in the public domain for any
legitimate uses of 4-piperidone, and has not documented a use for 4-
piperidone other than as an intermediary chemical in the production of
fentanyl. Based on the review of import and quota information for NPP,
ANPP, and fentanyl, DEA believes the vast majority of, if not all,
legitimate pharmaceutical fentanyl is produced via a synthetic route
involving NPP and ANPP as intermediaries, not 4-piperidone. The
quantities of NPP indicated in import data and quantities of ANPP
indicated in import and quota data generally correspond with the
quantities of legitimate pharmaceutical fentanyl produced in the United
States. Therefore, DEA concludes the vast majority of, if not all, 4-
piperidone undergoing chemical transactions is being used for the
manufacturing of illicit fentanyl. DEA cannot rule out the possibility
that minimal quantities of 4-piperidone is being used for the
manufacturing of legitimate pharmaceutical fentanyl. However, if there
are any quantities of 4-piperidone used for the manufacturing of
legitimate pharmaceutical fentanyl, the quantities are believed to be
small and economically insignificant. DEA requested public comment
regarding this estimate; however, no public comment was received during
the notice and comment period.
DEA evaluated the costs and benefits of this action.
Costs
DEA believes the market for 4-piperidone for the legitimate
manufacturing of pharmaceutical fentanyl is minimal. As stated above,
the only use for 4-piperidone of which DEA is aware is as an
intermediary for the manufacturing of fentanyl. Any manufacturer,
distributor, importer, or exporter of 4-piperidone for the production
of legitimate pharmaceutical fentanyl, if they exist at all, will incur
costs. The primary costs associated with this rule would be the annual
registration fees for list I chemicals ($3,699 for manufacturers and
$1,850 for distributors, importers, and exporters). However, any
manufacturer that uses 4-piperidone for legitimate pharmaceutical
fentanyl production would already be registered with DEA and have all
security and other handling processes in place because of the controls
already in place on fentanyl, resulting in minimal cost to those
entities. While different forms of handling the scheduled substance
versus the list I chemical (distribution of fentanyl vs exporting 4-
piperidone) could require a separate registration for the different
handling of the substances, if an entity is already registered to
handle, manufacture, import, or export a scheduled substance, the
entity would not need an additional registration for the list I
chemical, provided it is handling the list I chemical in the same
manner that it is registered for with the scheduled substance, or as a
coincident activity permitted by Sec. 1309.21. Even with the
possibility of these additional registrations, DEA believes that the
cost will be minimal.
DEA has identified 38 domestic suppliers of 4-piperidone. Only one
is registered to handle list I chemicals, the remaining 37 are not
registered with DEA to handle list I chemicals. It is difficult to
estimate how much 4-piperidone is distributed by these suppliers. It is
common for chemical distributors to have items in their catalog while
not actually having any material level of sales. Based on the review of
import and quota information for NPP, ANPP, and fentanyl, where the
quantities of NPP and ANPP imported and manufactured generally
correspond with the quantities of fentanyl produced, DEA believes any
quantity of sales from these distributors for legitimate pharmaceutical
fentanyl manufacturing is minimal. Suppliers for the legitimate use of
4-piperidone are expected to choose the least-cost option, and stop
selling the minimal quantities, if any, of 4-piperidone, rather than
incur the registration cost. Because DEA believes the quantities of 4-
piperidone supplied for the legitimate manufacturing of pharmaceutical
fentanyl are minimal, DEA estimates that the cost of foregone sales is
minimal; and thus, the cost of this rule is minimal. DEA requested
public comment regarding this estimate; however, no public comment was
received during the notice and comment period.
[[Page 21908]]
This analysis excludes consideration of any economic impact to
those businesses that facilitate the manufacturing and distribution of
4-piperidone for the manufacturing of illicit fentanyl. As a law
enforcement organization and as a matter of principle, DEA believes
considering the economic utility of facilitating the manufacture of
illicit fentanyl would be improper.
Benefits
Controlling 4-piperidone is expected to prevent, curtail, and limit
the unlawful manufacture and distribution of the controlled substance,
fentanyl. As a list I chemical, handling of 4-piperidone requires
registration with DEA and various controls and monitoring as required
by the CSA. This rule is also expected to assist preventing the
possible theft or diversion of 4-piperidone from any legitimate firms.
DEA also believes control is necessary to prevent unscrupulous chemists
from synthesizing 4-piperidone and selling it (as an unregulated
material) through the internet and other channels, to individuals who
may wish to acquire unregulated intermediary chemicals for the purpose
of illicitly manufacturing fentanyl.
In summary, DEA conducted a qualitative analysis of costs and
benefits. DEA believes this action will minimize the diversion of 4-
piperidone. DEA believes the market for 4-piperidone for the legitimate
manufacturing of pharmaceutical fentanyl is minimal. Therefore, any
potential cost as a result of this regulation is minimal.
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, minimize litigation, 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 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. This rule 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 Administrator, in accordance with the Regulatory Flexibility
Act (5 U.S.C. 601-612), has reviewed this rule and by approving it
certifies that it will not have a significant economic impact on a
substantial number of small entities. As discussed above, 4-piperidone
or a chemical mixture containing 4-piperidone shall be subject to all
of the regulatory controls and administrative, civil, and criminal
sanctions applicable to the manufacture, distribution, importing, and
exporting of list I chemicals. 4-Piperidone is a precursor chemical
used in, and is important to, the illicit manufacture of the schedule
II controlled substance fentanyl. The distribution of illicitly
manufactured fentanyl has caused an unprecedented outbreak of thousands
of fentanyl-related overdoses in the United States in recent years. DEA
has not identified any legitimate industrial use for 4-piperidone other
than its role as an intermediary chemical in the production of
fentanyl. However, DEA believes the vast majority, if not all, of
legitimate pharmaceutical fentanyl is produced via a synthetic route
involving NPP and ANPP as intermediaries, not 4-piperidone. The review
of import and quota information for fentanyl, ANPP, and NPP supports
this belief. Therefore, DEA believes the vast majority, if not all, of
4-piperidone is used for the illicit manufacturing of fentanyl. The
primary costs associated with this rule are the annual registration
fees ($3,699 for manufacturers and $1,850 for distributors, importers,
and exporters). Additionally, any manufacturer that uses 4-piperidone
for legitimate pharmaceutical fentanyl production would already be
registered with DEA and have all security and other handling processes
in place, resulting in minimal cost. DEA has identified 38 domestic
suppliers of 4-piperidone, 37 of which are not registered with DEA to
handle list I chemicals. All non-registered domestic suppliers are
affected and are estimated to be small entities (based on Small
Business Administration size standard for chemical distributors and
Statistics of U.S. Business data).\26\ It is impossible to know how
much 4-piperidone is distributed by these suppliers. It is common for
chemical distributors to have items in their catalog while not actually
having any material level of sales. Based on the review of import and
quota information for NPP, ANPP, and fentanyl, where the quantities of
NPP and ANPP imported and manufactured generally correspond with the
quantities of fentanyl produced, DEA believes any quantity of sales
from these distributors for legitimate pharmaceutical fentanyl
manufacturing is minimal. Therefore, DEA estimates the cost of this
rule on any affected small entity is minimal. DEA did not receive
public comment regarding this estimate. Based on these factors, DEA
projects that this rule will not result in a significant economic
impact on a substantial number of small entities.
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\26\ https://www.sba.gov/sites/default/files/2018-07/NAICS%202017%20Table%20of%20Size%20Standards.pdf.
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Unfunded Mandates Reform Act of 1995
On the basis of information contained in the ``Regulatory
Flexibility Act'' section above, DEA has determined and certifies
pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1501 et seq., 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 for inflation) in any one year . . . .''
Therefore, neither a Small Government Agency Plan nor any other action
is required under provisions of UMRA.
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 final rule to both Houses of Congress and to
the Comptroller General.
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
[[Page 21909]]
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.
List of Subjects in 21 CFR Part 1310
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
For the reasons set out above, DEA amends 21 CFR part 1310 as
follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES
0
1. The authority citation for part 1310 continues to read as follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
0
2. In Sec. 1310.02, add paragraph (a)(38) to read as follows:
Sec. 1310.02 Substances covered.
* * * * *
(a) * * *
(38) 4-piperidone (piperidin-4-one), its acetals, its amides, 8330
its carbamates, its salts, and salts of its acetals, its
amides, and its carbamates, and any combination thereof,
whenever the existence of such is possible.
* * * * *
0
3. In Sec. 1310.04:
0
a. Redesignate paragraphs (g)(1)(xvi) and (xvii) as paragraphs
(g)(1)(xvii) and (xviii), respectively; and
0
b. Add a new paragraph (g)(1)(xvi).
The addition reads as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(g) * * *
(1) * * *
(xvi) 4-piperidone (piperidin-4-one), its acetals, its amides, its
carbamates, its salts, and salts of its acetals, its amides, and its
carbamates, and any combination thereof, whenever the existence of such
is possible
* * * * *
0
4. In Sec. 1310.09, add paragraph (s) to read as follows:
Sec. 1310.09 Temporary exemption from registration.
* * * * *
(s)(1) Each person required under 21 U.S.C. 822 and 21 U.S.C. 957
to obtain a registration to manufacture, distribute, import, or export
regulated 4-piperidone (piperidin-4-one), its acetals, its amides, its
carbamates, its salts, and salts of its acetals, its amides, and its
carbamates, and any combination thereof, whenever the existence of such
is possible, including regulated chemical mixtures pursuant to Sec.
1310.12, is temporarily exempted from the registration requirement,
provided that DEA receives a properly completed application for
registration or application for exemption for a chemical mixture
containing 4-piperidone pursuant to Sec. 1310.13 on or before May 12,
2023. The exemption would remain in effect for each person who has made
such application until the Administration has approved or denied that
application. This exemption applies only to registration; all other
chemical control requirements set forth in the Act and parts 1309,
1310, 1313, and 1316 of this chapter remain in full force and effect.
(2) Any person who manufactures, distributes, imports, or exports a
chemical mixture containing 4-piperidone (piperidin-4-one), its
acetals, its amides, its carbamates, its salts, and salts of its
acetals, its amides, and its carbamates, and any combination thereof,
whenever the existence of such is possible whose application for
exemption is subsequently denied by DEA must obtain a registration with
DEA. A temporary exemption from the registration requirement will also
be provided for those persons whose application for exemption is
denied, provided that DEA receives a properly completed application for
registration on or before 30 days following the date of official DEA
notification that the application for exemption has been denied. The
temporary exemption for such persons will remain in effect until DEA
takes final action on their registration application.
0
5. In 1310.12, amend the table in paragraph (c) by adding in
alphabetical order an entry for ``4-piperidone (piperidin-4-one), its
acetals, its amides, its carbamates, its salts, and salts of its
acetals, its amides, and its carbamates, and any combination thereof,
whenever the existence of such is possible'' to read as follows:
Sec. 1310.12 Exempt chemical mixtures.
* * * * *
(c) * * *
Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
DEA chemical
code No. Concentration Special conditions
----------------------------------------------------------------------------------------------------------------
List I Chemicals
----------------------------------------------------------------------------------------------------------------
* * * * * * *
4-piperidone (piperidin-4-one), its 8330 Not exempt at any Chemical mixtures
acetals, its amides, its carbamates, concentration. containing any amount of
its salts, and salts of its acetals, 4-piperidone are not
its amides, and its carbamates, and exempt.
any combination thereof, whenever the
existence of such is possible.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[[Page 21910]]
* * * * *
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-07538 Filed 4-11-23; 8:45 am]
BILLING CODE 4410-09-P