[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.

[[Page 20825]]

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