Federal Register, Volume 85 Issue 73 (Wednesday, April 15, 2020)

[Federal Register Volume 85, Number 73 (Wednesday, April 15, 2020)]
[Rules and Regulations]
[Pages 20822-20829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07064]

[[Page 20822]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[Docket No. DEA-497]

Designation of Benzylfentanyl and 4-Anilinopiperidine, Precursor
Chemicals Used in the Illicit Manufacture of Fentanyl, as List I
Chemicals

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is finalizing the
designation of N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (also
known as benzylfentanyl), including its salts, and N-phenylpiperidin-4-
amine (also known as 4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-
AP) (hereinafter referred to as 4-anilinopiperidine), including its
amides, its carbamates, and its salts, as list I chemicals under the
Controlled Substances Act (CSA). DEA proposed control of benzylfentanyl
and 4-anilinopiperidine due to their use in clandestine laboratories to
illicitly manufacture the schedule II controlled substance fentanyl.
This rulemaking finalizes the control of benzylfentanyl and 4-
anilinopiperidine as list I chemicals.

DATES: This rulemaking will become effective on May 15, 2020. Persons
seeking registration must apply on or before May 15, 2020 to continue
their business pending final action by DEA on their application.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section (DPW), Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION: DEA is extremely concerned with the recent
increase in the illicit manufacture and distribution of fentanyl.
Therefore, on September 13, 2019, DEA published a Notice of Proposed
Rulemaking (NPRM) to control the precursor chemicals benzylfentanyl and
4-anilinopiperdine as list I chemicals. 84 FR 48314. This rulemaking
finalizes that NPRM.
This action subjects handlers of benzylfentanyl and 4-
anilinopiperidine to the chemical regulatory provisions of the CSA and
its implementing regulations. This rulemaking does not establish a
threshold for domestic and international transactions of benzylfentanyl
or 4-anilinopiperidine. As such, all transactions involving
benzylfentanyl or 4-anilinopiperidine are regulated, regardless of
transaction size or quantity, and are subject to control under the CSA.
In addition, chemical mixtures containing benzylfentanyl or 4-
anilinopiperidine are not exempt from regulatory requirements at any
concentration. Therefore, all transactions of chemical mixtures
containing any quantity of benzylfentanyl or 4-anilinopiperidine are
regulated pursuant to the CSA.

Legal Authority

The CSA gives the Attorney General the authority to specify, by
regulation, chemicals as list I or list II chemicals. 21 U.S.C. 802(34)
and (35). A ``list I chemical'' is a chemical that is used in
manufacturing a controlled substance in violation of Title II of the
CSA and is important to the manufacture of the controlled substance. 21
U.S.C. 802(34). A ``list II chemical'' is a chemical (other than a list
I chemical) that is used in manufacturing a controlled substance in
violation of Title II of the CSA. 21 U.S.C. 802(35). The current list
of all listed chemicals is published at 21 CFR 1310.02. Pursuant to 28
CFR 0.100(b), the Attorney General has delegated his authority to
designate list I and list II chemicals to the Administrator of the Drug
Enforcement Administration.

Background

DEA is extremely concerned with the increase in the illicit
manufacture and distribution of fentanyl. Fentanyl is a synthetic
opioid and was first synthesized in Belgium in the late 1950's.
Fentanyl is controlled in schedule II of the CSA due to its high
potential for abuse and dependence, and accepted medical use in
treatment in the United States. Fentanyl was introduced into medical
practice and is approved for medical practitioners in the United States
to prescribe lawfully for anesthesia and analgesia. Due to its
pharmacological effects, fentanyl can serve as a substitute for heroin,
oxycodone, and other opioids in opioid dependent individuals.
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.
DEA has noted a significant increase in overdoses and overdose
fatalities from fentanyl in the United States in recent years. A recent
report \1\ from the Centers for Disease Control and Prevention (CDC)
highlights this trend. According to this report, of the 41,430 drug
overdose deaths occurring in the United States in 2011, 1,662 (4.0
percent) involved fentanyl.\2\ Of the 63,632 drug overdose deaths in
2016, 18,335 (28.8 percent) involved fentanyl. This was the first time
that fentanyl was reported in more drug related fatalities than heroin.
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\1\ Drugs Most Frequently Involved in Drug Overdose Deaths:
United States, 2011-2016. National Vital Statistics Reports; vol 67
no 9. Hyattsville, MD: National Center for Health Statistics, 2018.
\2\ The reported data includes fentanyl, fentanyl metabolites,
precursors, and analogs.
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The increase of drug overdose deaths continued into 2017. According
to the CDC,\3\ there were 70,237 drug overdose deaths in the United
States in 2017, an increase from the 63,632 overdose deaths recorded in
2016. Of the 70,237 overdose deaths in 2017, 47,600 (67.8 percent)
involved an opioid. Deaths involving prescription opioids and heroin
remained stable from 2016 to 2017; synthetic opioid overdose deaths
(other than methadone), which include deaths involving fentanyl,
increased 45.2 percent from 19,413 deaths in 2016 to 28,466 deaths in
2017.
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\3\ Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and
Opioid-Involved Overdose Deaths--United States, 2013-2017. MMWR Morb
Mortal Wkly Rep 2019;67:1419-1427.
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The increase in overdose fatalities involving fentanyl coincides
with a dramatic increase of law enforcement encounters of fentanyl.
According to the National Forensic Laboratory Information System
(NFLIS),\4\ submissions to forensic laboratories that contained
fentanyl increased exponentially beginning in 2012: 694 in 2012, 1,044
in 2013, 5,537 in 2014, 15,455 in 2015, 37,294 in 2016, 61,382 in 2017,
and 70,453 in 2018.
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\4\ The National Forensic Laboratory Information System (NFLIS)
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. NFLIS data was queried on March 26, 2019.
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Role of These Precursor Chemicals 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
an organic molecule is created through a series of chemical reactions,
which involve precursor

[[Page 20823]]

chemicals. In the early 2000's, a synthetic process, commonly known as
the Siegfried method, was utilized to manufacture fentanyl in several
domestic and foreign clandestine laboratories. 72 FR 20039. At that
time, DEA had determined that two primary synthesis routes (i.e., the
Janssen method and the Siegfried method) were being used to produce
fentanyl clandestinely, although it believed the Janssen synthesis
route to be difficult to perform and beyond the rudimentary skills of
most clandestine laboratory operators. The Siegfried synthetic route
involves two important intermediates, N-phenethyl-4-piperidone (NPP)
and 4-anilino-N-phenethylpiperidine (ANPP). DEA controlled NPP on April
23, 2007, as a list I chemical through an interim rule (72 FR 20039),
which was finalized on July 25, 2008. 73 FR 43355. ANPP was controlled
as a schedule II immediate precursor to fentanyl on August 30, 2010. 75
FR 37295.
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 control these precursor chemicals at the national level. In
addition, the People's Republic of China controlled NPP and ANPP on
February 1, 2018.
Recent law enforcement information indicates that illicit
manufacturers of fentanyl may utilize synthetic routes other than the
Siegfried method in response to international controls placed on NPP
and ANPP. The Janssen method, previously thought to be beyond the
skills of most clandestine laboratory operators, is now used with the
precursor chemical benzylfentanyl, and other synthetic routes use the
precursor chemical 4-anilinopiperidine. DEA is not aware of any
legitimate uses of benzylfentanyl or 4-anilinopiperidine other than in
the synthesis of fentanyl.

Benzylfentanyl

The original published synthetic pathway to fentanyl, known as the
Janssen method, does not involve NPP or ANPP as a chemical precursor.
This synthetic pathway involves the important precursors,
benzylfentanyl and norfentanyl. Benzylfentanyl is converted to N-
phenyl-N-(piperidin-4-yl)propionamide (norfentanyl), the immediate
precursor in this synthetic pathway, in one chemical reaction.
Norfentanyl is then subjected to one simple chemical reaction to
complete the synthesis of fentanyl.
According to DEA forensic laboratory data, the Janssen method was
confirmed as the synthetic route used in 94 percent of 85 fentanyl drug
exhibits that were evaluated to determine the synthetic route. These
exhibits were seized in 2018. In addition, the number of law
enforcement encounters of benzylfentanyl has increased in 2017 and
2018, which coincides with the international control that placed NPP
and ANPP in Table I of the 1988 Convention in 2017.
According to NFLIS, there was one identification of benzylfentanyl
in 2016; however, benzylfentanyl was identified in 195 reports in 2017
and 237 reports in 2018. Since DEA is not aware of any legitimate uses
of benzylfentanyl other than potentially in the synthesis of fentanyl,
it is believed that these law enforcement encounters indicate a change
in the synthetic route to the Janssen method by some clandestine
manufacturers in efforts to evade chemical regulations on NPP and ANPP.
DEA has determined that benzylfentanyl is commercially available
from both domestic and foreign chemical suppliers. DEA is aware of at
least five domestic suppliers and three foreign suppliers in China, two
suppliers in Canada, and one supplier in the United Kingdom.
Benzylfentanyl is attractive to illicit manufacturers due to the lack
of chemical regulations on this substance, it is readily available from
chemical suppliers, and it can be converted to the immediate precursor,
norfentanyl, in a one-step chemical reaction.

4-Anilinopiperidine

In addition to the Janssen and Siegfried methods, clandestine
manufacturers are using other methods to synthesize fentanyl. 4-
Anilinopiperidine can serve as an alternative precursor chemical to NPP
in the synthesis of ANPP, albeit through a different synthetic process.
4-Anilinopiperidine has been marketed as a replacement to ANPP as a
precursor chemical used in the illicit manufacture of fentanyl by
foreign chemical suppliers. This is believed to be in response to
international controls placed on NPP and ANPP. Although marketed as a
replacement for ANPP, DEA understands that 4-anilinopiperidine is not a
direct replacement for ANPP in the synthesis of fentanyl. DEA is not
aware of any legitimate uses of 4-anilinopiperidine other than
potentially in the synthesis of fentanyl. In contrast to NPP, where two
chemical reaction steps are required to synthesize ANPP, 4-
anilinopiperidine can be converted to ANPP in a one-step chemical
reaction. The resulting ANPP can then be used as the immediate
precursor chemical in the illicit manufacture of the schedule II
controlled substance, fentanyl. ANPP was controlled in schedule II of
the CSA as of August 30, 2010 for this reason. 75 FR 37295 (June 29,
2010).
4-Anilinopiperidine has been imported and identified in law
enforcement seizures in the United States. In addition to domestic
encounters, DEA is aware of international encounters of 4-
anilinopiperidine beginning as early as July 2018. The International
Narcotics Control Board of the United Nations reported 32 international
transactions of 4-anilinopiperidine through the International
Operations on Novel Psychoactive Substances Communication System
(IONICS) \5\ reporting system. These identifications, totaling
approximately 30 kg, were reported by Mexico as the destination
country. In addition, 4-anilinopiperidine was identified at a
clandestine laboratory located in Mexico, which was involved in the
illicit manufacture of fentanyl.
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\5\ IONICS is a free communication platform dedicated to real-
time communication of incidents involving suspicious shipments,
trafficking, manufacture or production of Novel Psychoactive
Substances (NPS). IONICS reports were collected up to April 1, 2019.
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These recent law enforcement encounters of 4-anilinopiperidine
coincide with the placement of NPP and ANPP in Table I of the 1988
Convention, and the February 1, 2018, control of NPP and ANPP in the
People's Republic of China. The international encounters of 4-
anilinopiperidine at ports of entry in Mexico indicate a change in
illicit fentanyl manufacturing methods in efforts to evade
international controls on NPP and ANPP.
DEA determined that 4-anilinopiperidine is commercially available
from both domestic and foreign chemical suppliers. DEA has identified
38 domestic suppliers and 28 foreign suppliers of 4-anilinopiperidine
from Canada (3), China (11), Germany (3), Hong Kong (1), India (1),
Latvia (1), Lithuania (1), Switzerland (2), and the United Kingdom (5).
4-Anilinopiperidine is attractive to illicit manufacturers due to the
lack of chemical controls on this substance, it is readily available
from chemical suppliers, and it can easily be converted to the schedule
II immediate precursor, ANPP, which can subsequently be converted to
fentanyl.

[[Page 20824]]

Regulation of Benzylfentanyl, Including Its Salts and 4-
Anilinopiperidine, Including Its Amides, Its Carbamates, and Its Salts,
as List I Chemicals

The CSA, specifically 21 U.S.C. 802(34), 21 U.S.C. 802(35), 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 benzylfentanyl and 4-
anilinopiperidine are being used in the illicit manufacture of the
schedule II controlled substance fentanyl.
On September 13, 2019, DEA published an NPRM proposing control of
benzylfentanyl and 4-anilinopiperidine as list I chemicals due to their
use in clandestine laboratories to illicitly manufacture the schedule
II controlled substance fentanyl. This rulemaking finalizes the control
of benzylfentanyl and 4-anilinopiperidine as list I chemicals because
DEA finds that benzylfentanyl and 4-anilinopiperidine are used in the
manufacture of the controlled substance fentanyl, and are important to
the manufacture of the controlled substance fentanyl because they
cannot be replaced by other chemicals in their respective synthetic
pathways in the manufacture of fentanyl.

Comments Received

As part of the NPRM published on September 13, 2019 (84 FR 48314),
DEA specifically solicited comment on any possible legitimate uses of
benzylfentanyl and 4-anilinopiperidine unrelated to fentanyl production
(including industrial uses) in order to assess the potential commercial
impact of controlling benzylfentanyl and 4-anilinopiperidine. DEA had
searched information in the public domain for legitimate uses of these
two chemicals, and had not documented a legitimate commercial use for
benzylfentanyl or 4-anilinopiperidine 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
benzylfentanyl and 4-anilinopiperidine that are not in the public
domain. Therefore, DEA solicited comment on the uses of benzylfentanyl
and 4-anilinopiperidine in the legitimate marketplace.
DEA solicited input from all potentially affected parties
regarding: (1) The types of legitimate industries using benzylfentanyl
and 4-anilinopiperidine; (2) the legitimate uses of benzylfentanyl and
4-anilinopiperidine, if any; (3) the size of the domestic market for
benzylfentanyl and 4-anilinopiperidine; (4) the number of manufacturers
of benzylfentanyl and 4-anilinopiperidine; (5) the number of
distributors of benzylfentanyl and 4-anilinopiperidine; (6) the level
of import and export of benzylfentanyl and 4-anilinopiperidine; (7) the
potential burden these proposed regulatory controls of benzylfentanyl
and 4-anilinopiperidine may have on any legitimate commercial
activities; (8) the potential number of individuals/firms that may be
adversely affected by these proposed 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 benzylfentanyl and 4-anilinopiperidine
by industry and others. DEA invited all interested parties to provide
any information on any legitimate uses of benzylfentanyl and 4-
anilinopiperidine 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 four comments. Two commenters
were in support of controlling benzylfentanyl and 4-anilinopiperidine
as list I chemicals. One commenter expressed concern over a regulatory
mechanism that would place benzylfentanyl and 4-anilinopiperidine in
schedule I of the CSA. One commenter submitted a response that was
outside the scope of the action.
Comment: One commenter stated that this rule will be an integral
part of domestic regulation of illegal fentanyl by decreasing
manufacture of illegal fentanyl. This commenter also expressed concern
about the ease of obtaining, and importing illegal fentanyl and
chemical precursors into the United States.
DEA response: DEA agrees that this rule is an important step in
decreasing illicit fentanyl production and making it more difficult to
obtain and import these chemical precursors into the United States.
This rule provides law enforcement a tool to identify and investigate
illicit fentanyl manufacturers. As list I chemicals, imports and
exports of benzylfentanyl and 4-anilinopiperidine will be regulated per
21 CFR part 1313.
Comment: One commenter stated that benzylfentanyl and 4-
anilinopiperidine must be regulated as list I chemicals to reduce
illicit access to fentanyl. The commenter expressed concern about
uncontrolled illicit production of fentanyl and the recent outcomes of
fentanyl abuse in the United States.
DEA response: DEA agrees with the comment in support of controlling
benzylfentanyl and 4-anilinopiperidine as list I chemicals. 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 expressed concern about a regulatory
mechanism that places benzylfentanyl and 4-anilinopiperidine in
schedule I. The commenter proposed a separate regulatory avenue for
precursors which submits them to scrutiny, study, and regulation in
order to protect the public without resorting to the use of schedule I
regulation. The commenter further stated that schedule I designations
have a long history of hampering research and advancement of medicine
in the United States.
DEA response: This rule does not place benzylfentanyl and 4-
anilinopiperidine in schedule I of the CSA. The CSA currently provides
a mechanism to regulate precursor chemicals separately, which is the
authority utilized in this rule. 21 U.S.C. 802(34). Since
benzylfentanyl and 4-anilinopiperidine are not subject to schedule I
regulations, the comment is unrelated to this action. However, DEA
supports and encourages legitimate research on schedule I controlled
substances.
Comment: One commenter stated that controlling benzylfentanyl and
4-anilinopiperidine as list I chemicals is a bad idea and recommended
keeping the government from micromanaging our economy and hobbling
future production for emergencies. The commenter also stated that
fentanyl gas can be used in hostage situations.
DEA response: 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 believes that
this rule will not have a significant impact on the economy or on
legitimate manufacture of fentanyl. DEA also believes any potential
cost as a result of this regulation is minimal. The comment regarding
hostage situations is outside the scope of this rule.

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Chemical Mixtures of Benzylfentanyl and 4-Anilinopiperidine

Under this rulemaking, chemical mixtures containing benzylfentanyl
or 4-anilinopiperidine shall not be exempt from regulatory requirements
at any concentration, unless an application for exemption of a chemical
mixture is submitted by a benzylfentanyl or 4-anilinopiperidine
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 benzylfentanyl or 4-
anilinopiperidine is necessary to prevent the illicit extraction,
isolation, and use of benzylfentanyl or 4-anilinopiperidine to
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 benzylfentanyl or 4-anilinopiperidine 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. 21 CFR
1310.13. 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 (i.e., it meets the
conditions in 21 U.S.C. 802(39)(A)(vi)).

Requirements for Handling List I Chemicals

This final rule subjects benzylfentanyl and 4-anilinopiperidine 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 benzylfentanyl or 4-anilinopiperidine, including
regulated chemical mixtures containing benzylfentanyl or 4-
anilinopiperidine, shall be required to comply with list I chemical
regulations, including the following:
1. Registration. Any person who manufactures, distributes, imports,
or exports benzylfentanyl or 4-anilinopiperidine, or proposes to engage
in the manufacture, distribution, importation, or exportation of
benzylfentanyl or 4-anilinopiperidine, 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.
Upon the effective date of this final rule, any person
manufacturing, distributing, importing, or exporting benzylfentanyl or
4-anilinopiperidine, or a chemical mixture containing benzylfentanyl or
4-anilinopiperidine, will become subject to the registration
requirement under the CSA. However, DEA recognizes that it is not
possible for persons who are subject to the registration requirement to
immediately complete and submit an application for registration and for
DEA to immediately issue registrations for those activities. Therefore,
to allow continued legitimate commerce in benzylfentanyl and 4-
anilinopiperidine, DEA is establishing in 21 CFR 1310.09, a temporary
exemption from the registration requirement for persons desiring to
engage in activities with benzylfentanyl or 4-anilinopiperidine,
provided that DEA receives a properly completed application for
registration or exemption of a chemical mixture on or before May 15,
2020. 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 benzylfentanyl or
4-anilinopiperidine, nor does it supersede State or local laws or
regulations. All handlers of benzylfentanyl or 4-anilinopiperidine 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 benzylfentanyl and 4-
anilinopiperidine pursuant to 21 U.S.C. 830 and in accordance with 21
CFR part 1310. 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. 21 CFR
1310.05(d). Existing standard industry reports containing the required
information are acceptable, provided the information is separate or
readily retrievable from the report.
3. Importation and Exportation. All importation and exportation of
benzylfentanyl or 4-anilinopiperidine 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.
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 CFR part 1316, subpart A. 21 U.S.C. 880.
6. Liability. Any activity involving benzylfentanyl or 4-
anilinopiperidine 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, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs

This final rulemaking, which adds benzylfentanyl and 4-
anilinopiperidine as list I chemicals, was developed in accordance with
the principles of Executive Orders 12866, 13563, and 13771. Executive
Order 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). Executive Order 13563 is
supplemental to and reaffirms the principles, structures, and
definitions governing regulatory review as established in Executive
Order 12866. Executive Order 12866 classifies a ``significant
regulatory action,'' requiring review by the Office of

[[Page 20826]]

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 Executive Order. DEA has determined that this rule is not a
``significant regulatory action'' under Executive Order 12866, section
3(f).
Executive Order 13771 requires an agency, unless prohibited by law,
to identify at least two existing regulations to be repealed when the
agency publicly proposes for notice and comment or otherwise
promulgates a new regulation.\6\ In furtherance of this requirement,
Executive Order 13771 requires that the new incremental costs
associated with new regulations, to the extent permitted by law, be
offset by the elimination of existing costs associated with at least
two prior regulations.\7\ According to guidance provided by OMB, the
requirements of Executive Order 13771 only apply to each new
``significant regulatory action that . . . imposes costs.'' \8\ This
rule is not an Executive Order 13771 regulatory action because this
rule is not significant under Executive Order 12866.
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\6\ Sec. 2(a).
\7\ Sec. 2(c).
\8\ OMB Guidance Implementing Executive Order 13771 titled
``Reducing Regulation and Controlling Regulatory Costs'' (April 5,
2017).
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This final rulemaking subjects benzylfentanyl and 4-
anilinopiperidine to all of the regulatory controls and administrative,
civil, and criminal sanctions applicable to the manufacture,
distribution, importing, and exporting of list I chemicals.
Benzylfentanyl and 4-anilinopiperidine are used in, and are 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 these two chemicals, and has not documented a use
for benzylfentanyl or 4-anilinopiperidine other than as intermediary
chemicals 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 benzylfentanyl (and norfentanyl) or 4-
anilinopiperidine. The quantities of NPP and ANPP indicated in import
and quota documents generally correspond with the quantities of
legitimate pharmaceutical fentanyl produced in the United States.
Therefore, DEA concludes the vast majority of, if not all,
benzylfentanyl or 4-anilinopiperidine is used for the manufacturing of
illicit fentanyl.
DEA cannot rule out the possibility that minimal quantities of
benzylfentanyl or 4-anilinopiperidine are used for the manufacturing of
legitimate pharmaceutical fentanyl. However, if there are any
quantities of benzylfentanyl or 4-anilinopiperidine used for the
manufacturing of legitimate pharmaceutical fentanyl, the quantities are
believed to be small and economically insignificant. DEA did not
receive comment to the contrary.
DEA evaluated the costs and benefits of this action.
Costs
DEA believes the market for benzylfentanyl or 4-anilinopiperidine
for the legitimate manufacturing of pharmaceutical fentanyl is minimal.
As stated above, the only use for benzylfentanyl and 4-
anilinopiperidine of which DEA is aware is as intermediaries for the
manufacturing of fentanyl. Any manufacturer, distributor, importer, or
exporter of benzylfentanyl or 4-anilinopiperidine for the production of
legitimate pharmaceutical fentanyl, if they exist at all, will incur
costs upon the effective date of this final rule. The primary costs
associated with this rule would be the annual registration fees for
scheduled drugs or list I chemicals ($3,047 for manufacturers and
$1,523 for distributors, importers, and exporters). However, any
manufacturer that uses benzylfentanyl or 4-anilinopiperidine 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 benzylfentanyl) 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 21 CFR
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 benzylfentanyl, 4-
anilinopiperidine, or both. 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 benzylfentanyl and 4-
anilinopiperidine is distributed by these suppliers. It is common for
chemical distributors to have items on 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. Upon the effective date of this final rule,
suppliers for the legitimate use of benzylfentanyl or 4-
anilinopiperidine are expected to choose the least-cost option, and
stop selling the minimal quantities, if any, of benzylfentanyl or 4-
anilinopiperidine, rather than incur the registration cost. Because DEA
believes the quantities of benzylfentanyl or 4-anilinopiperidine
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.
This analysis excludes consideration of any economic impact to
those businesses that facilitate the manufacturing and distribution of
benzylfentanyl or 4-anilinopiperidine for the production of
manufacturing 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.

[[Page 20827]]

Benefits
Controlling benzylfentanyl and 4-anilinopiperidine is expected to
prevent, curtail, and limit the unlawful manufacture and distribution
of the controlled substance, fentanyl. As list I chemicals, handling of
benzylfentanyl and 4-anilinopiperidine 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 benzylfentanyl and 4-anilinopiperidine from any legitimate firms.
DEA also believes control is necessary to prevent unscrupulous chemists
from synthesizing benzylfentanyl and 4-anilinopiperidine 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 manufacturing illicit fentanyl.
In summary, DEA conducted a qualitative analysis of costs and
benefits. DEA believes this action will minimize the diversion of
benzylfentanyl and 4-anilinopiperidine. DEA believes the market for
benzylfentanyl and 4-anilinopiperidine 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 Executive Order 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 Executive Order 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 Executive Order 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 Acting 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,
benzylfentanyl and 4-anilinopiperidine 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 upon the effective date of this rulemaking.
Benzylfentanyl and 4-anilinopiperidine are used in, and are 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 benzylfentanyl and 4-
anilinopiperidine, other than their role as intermediary chemicals 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
benzylfentanyl (and norfentanyl) or 4-anilinopiperidine. 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
benzylfentanyl or 4-anilinopiperidine is used for the illicit
manufacturing of fentanyl. DEA did not receive comment to the contrary.
The primary costs associated with this rule are the annual registration
fees ($3,047 for manufacturers and $1,523 for distributors, importers,
and exporters). Additionally, any manufacturer that uses benzylfentanyl
or 4-anilinopiperidine 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 benzylfentanyl, 4-
anilinopiperidine, or both, 37 of which are not registered with DEA to
handle list I chemicals. All 37 non-registered domestic suppliers are
affected, of which 35 (94.5%, based on Small Business Administration
size standard for chemical distributors and Statistics of U.S. Business
data) are estimated to be small entities. It is impossible to know how
much benzylfentanyl or 4-anilinopiperidine is distributed by these
suppliers. It is common for chemical distributors to have items on
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. DEA
did not receive comment to the contrary. 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.

Paperwork Reduction Act

This action does not impose a new collection of information
requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521.
This action would not impose recordkeeping or reporting requirements on
State or local governments, individuals, businesses, or organizations.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.

List of Subjects in 21 CFR Part 1310

Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.

For the reasons set out above, DEA amends 21 CFR part 1310 as
follows:

[[Page 20828]]

PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES

0
1. The authority citation for 21 CFR 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 paragraphs (a)(32) and (33) to read as follows:

Sec. 1310.02 Substances covered.

* * * * *
(a) * * *

(32)N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide 8334
(benzylfentanyl) and its salts.........................
(33)N-phenylpiperidin-4-amine(4-anilinopiperidine; N- 8335
phenyl-4-piperidinamine; 4-AP), its amides, its
carbamates, and its salts..............................

* * * * *

0
3. In Sec. 1310.04:
0
a. Redesignate paragraphs (g)(1)(viii) through (xi) as paragraphs
(g)(1)(x) through (xiii), respectively;
0
b. Redesignate paragraph (g)(1)(vii) as paragraph (g)(1)(viii); and
0
c. Add new paragraphs (g)(1)(vii) and (ix).
The additions read as follows:

Sec. 1310.04 Maintenance of records.

* * * * *
(g) * * *
(1) * * *
(vii) N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide
(benzylfentanyl) and its salts
* * * * *
(ix) N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-
piperidinamine; 4-AP), its amides, its carbamates, and its salts
* * * * *

0
4. In Sec. 1310.09 add paragraphs (o) and (p) to read as follows:

Sec. 1310.09 Temporary exemption from registration.

* * * * *
(o)(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 N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide
(benzylfentanyl) and its salts, including regulated chemical mixtures
pursuant to Sec. 1310.12, is temporarily exempted from the
registration requirement, provided that DEA receives a proper
application for registration or application for exemption for a
chemical mixture containing benzylfentanyl pursuant to Sec. 1310.13 on
or before May 15, 2020. The exemption will 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 N-(1-benzylpiperidin-4-yl)-N-
phenylpropionamide (benzylfentanyl) and its salts 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.
(p)(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 N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-
piperidinamine, 4-AP) and its amides, its carbamates, and its salts,
including regulated chemical mixtures pursuant to Sec. 1310.12, is
temporarily exempted from the registration requirement, provided that
DEA receives a proper application for registration or application for
exemption for a chemical mixture containing 4-anilinopiperidine
pursuant to Sec. 1310.13 on or before May 15, 2020. The exemption will
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 N-phenylpiperidin-4-amine (4-
anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP) and its amides, its
carbamates, and its salts 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 Sec. 1310.12, the Table of Concentration Limits in paragraph (c)
is amended by adding entries for ``N-(1-benzylpiperidin-4-yl)-N-
phenylpropionamide (benzylfentanyl)'' and ``N-phenylpiperidin-4-amine
(4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP)'' in
alphabetical order to read as follows:

Sec. 1310.12 Exempt chemical mixtures.

* * * * *
(c) * * *

[[Page 20829]]

Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
DEA chemical
code No. Concentration Special conditions
----------------------------------------------------------------------------------------------------------------

* * * * * *
N-(1-benzylpiperidin-4-yl)-N- 8334 Not exempt at any Chemical mixtures
phenylpropionamide (benzylfentanyl), concentration. containing any amount of
including its salts. benzylfentanyl are not
exempt.
N-phenylpiperidin-4-amine (4- 8335 Not exempt at any Chemical mixtures
anilinopiperidine; N-phenyl-4- concentration. containing any amount of
piperidinamine; 4-AP), including its 4-anilinopiperidine are
amides, its carbamates, and its salts. not exempt.

* * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-07064 Filed 4-14-20; 8:45 am]
BILLING CODE 4410-09-P