[Federal Register Volume 84, Number 178 (Friday, September 13, 2019)]
[Proposed Rules]
[Pages 48314-48321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19787]


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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: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) is proposing the 
control 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).
    Benzylfentanyl and 4-anilinopiperidine are used in, and are 
important to, the illicit manufacture of the schedule II controlled 
substance fentanyl. If finalized, this action would subject 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 of chemical mixtures containing benzylfentanyl or 4-
anilinopiperidine will be regulated at any concentration and will be 
subject to control under the CSA.

DATES: Comments must be submitted electronically or postmarked on or 
before November 12, 2019. Commenters should be aware that the 
electronic Federal Docket Management System will not accept any 
comments after 11:59 p.m. Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-497'' on all electronic and written correspondence, 
including any attachments.
     Electronic comments: The DEA encourages that all comments 
be submitted electronically through the Federal eRulemaking Portal 
which provides the ability to type short comments directly into the 
comment field on the web page or attach a file for lengthier comments. 
Please go to http://www.regulations.gov and follow the online 
instructions at that site for submitting comments. Upon completion of 
your submission, you will receive a Comment Tracking Number for your 
comment. Please be aware that submitted comments are not 
instantaneously available for public view on Regulations.gov. If you 
have received a Comment Tracking Number, your comment has been 
successfully submitted and there is no need to resubmit the same 
comment.
     Paper comments: Paper comments that duplicate electronic 
submissions are not necessary. Should you wish to mail a paper comment, 
in lieu of an electronic comment, it should be sent via regular or 
express mail to: Drug Enforcement Administration, Attn: DEA Federal 
Register Representative/DPW, 8701 Morrissette Drive, Springfield, 
Virginia 22152.

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: (202) 598-6812.

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the DEA for public inspection 
online at http://www.regulations.gov. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter. The Freedom of Information Act 
(FOIA) applies to all comments received. If you want to submit personal 
identifying information (such as your name, address, etc.) as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the 
first paragraph of your comment. You must also place all of the 
personal identifying information you do not want made publicly 
available in the first paragraph of your comment and identify what 
information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified as directed above will be 
made publicly available in redacted form. If a comment has so much 
confidential business information that it cannot be effectively 
redacted, all or part of that comment may not be made publicly 
available. Comments posted to http://www.regulations.gov may include 
any personal identifying information (such as name, address, and phone 
number) included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this proposed rule is available at http://www.regulations.gov for easy reference.

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

    The 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

[[Page 48315]]

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.
    The 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%) 
involved fentanyl.\2\ Of the 63,632 drug overdose deaths in 2016, 
18,335 (28.8%) 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%) 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 related to fentanyl, increased 45.2% 
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 
a new organic molecule is created through a series of chemical 
reactions, which involve precursor 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). The 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 regulate these precursor chemicals at the national level. In 
addition, the People's Republic of China regulated 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 regulations 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. The 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. Norfentanyl is the subject of a 
Notice of Proposed Rulemaking for control as a schedule II immediate 
precursor of fentanyl, published elsewhere in this issue of the Federal 
Register.
    According to DEA forensic laboratory data, the Janssen method was 
confirmed as the synthetic route used in 94% 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 of 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 the 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.
    The DEA has determined that benzylfentanyl is commercially 
available from both domestic and foreign chemical suppliers. The 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.

[[Page 48316]]

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. The 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 is 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, the 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 regulation 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.
    The DEA determined that 4-anilinopiperidine is commercially 
available from both domestic and foreign chemical suppliers. The 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.

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. This proposed rule would 
regulate benzylfentanyl and 4-anilinopiperidine as list I chemicals 
because the 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.

Chemical Mixtures of Benzylfentanyl and 4-Anilinopiperidine

    This proposed rulemaking, if finalized, would specify that chemical 
mixtures containing benzylfentanyl or 4-anilinopiperidine would 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 the 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 proposed rule would 
modify 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

    The 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 the 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

    If this rule is finalized as proposed, benzylfentanyl and 4-
anilinopiperidine will 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 publication of a final rule, persons potentially 
handling benzylfentanyl or 4-anilinopiperidine, including regulated 
chemical mixtures containing benzylfentanyl or 4-anilinopiperidine, 
will 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, 958. Regulations describing 
registration for list I chemical handlers are set forth in 21 CFR part 
1309.
    The DEA recognizes that it is not possible for persons who are 
subject to

[[Page 48317]]

the registration requirements to immediately complete and submit an 
application for registration, and for the DEA to immediately issue 
registrations for those activities. Therefore, to allow any continued 
legitimate commerce in benzylfentanyl and 4-anilinopiperidine, the DEA 
is proposing to establish 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 
the DEA receives a properly completed application for registration or 
application for exemption of a chemical mixture under 21 CFR 1310.13 on 
or before 30 days after publication of a final rule implementing 
regulations regarding benzylfentanyl and 4-anilinopiperidine. The 
temporary exemption for such persons will remain in effect until the 
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 the 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 would be required to 
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 will be 
required to 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 would need to 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 would be required to 
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.

Solicitation for Information

    As part of this proposed rulemaking, the DEA is soliciting 
information 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. The DEA has 
searched information in the public domain for legitimate uses of these 
two chemicals, and has not documented a legitimate commercial use for 
benzylfentanyl or 4-anilinopiperidine other than as intermediary 
chemicals in the production of fentanyl. The DEA seeks, 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, the DEA is soliciting comment on the uses of 
benzylfentanyl and 4-anilinopiperidine in the legitimate marketplace.
    The DEA is soliciting 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. The DEA invites 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. The DEA seeks both quantitative and 
qualitative data.

Handling of Confidential or Proprietary Information

    Confidential or proprietary information may be submitted as part of 
a comment regarding this Notice of Proposed Rulemaking. Please see the 
``POSTING OF PUBLIC COMMENTS'' section above for a discussion of the 
identification and redaction of confidential business information and 
personally identifying information.

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 proposed rule 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 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,

[[Page 48318]]

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. The DEA has determined that this 
proposed 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 
proposed rule is not expected to be an E.O. 13771 regulatory action 
because this proposed rule is not significant under E.O. 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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    If finalized as proposed, benzylfentanyl and 4-anilinopiperidine 
will 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. 
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.
    The 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, The 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 U.S. Therefore, the 
DEA concludes the vast majority of, if not all, benzylfentanyl or 4-
anilinopiperidine is used for the manufacturing of illicit fentanyl.
    The 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. The DEA welcomes 
any public comment on these quantities and their economic significance.
    The DEA evaluated the costs and benefits of this proposed action.
Costs
    The 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 the 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, 
would incur costs if this proposed rule were finalized. The primary 
costs associated with this proposed 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 the 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 Sec.  1309.21. Even with the possibility of these additional 
registrations, the DEA believes that the cost will be minimal.
    The 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 the 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, the DEA believes 
any quantity of sales from these distributors for legitimate 
pharmaceutical fentanyl manufacturing is minimal. If this proposed rule 
is finalized, 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 the 
DEA believes the quantities of benzylfentanyl or 4-anilinopiperidine 
supplied for the legitimate manufacturing of pharmaceutical fentanyl 
are minimal, the DEA estimates that the cost of foregone sales is 
minimal; and thus, the cost of this proposed rule is minimal. The DEA 
welcomes any public comment regarding this estimate.
    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, the DEA believes considering the economic 
utility of facilitating the manufacture of illicit fentanyl would be 
improper.
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

[[Page 48319]]

and 4-anilinopiperidine would require registration with the DEA and 
various controls and monitoring as required by the CSA. This proposed 
rule is also expected to assist preventing the possible theft or 
diversion of benzylfentanyl and 4-anilinopiperidine from any legitimate 
firms. The 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, the DEA conducted a qualitative analysis of costs and 
benefits. The DEA believes this proposed action, if finalized, will 
minimize the diversion of benzylfentanyl and 4-anilinopiperidine. The 
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 proposed 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 proposed rulemaking does not have federalism implications 
warranting the application of Executive Order 13132. The proposed rule 
does not have substantial direct effects on the States, on the 
relationship between the national government and the States, or the 
distribution of power and responsibilities among the various levels of 
government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This proposed rule does not have tribal implications warranting the 
application of Executive Order 13175. This proposed 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) (RFA), has reviewed this proposed 
rule and by approving it certifies that it will not have a significant 
economic impact on a substantial number of small entities. As discussed 
above, if finalized as proposed, benzylfentanyl and 4-anilinopiperidine 
will 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. 
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. The 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, the 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, the DEA believes the vast majority, if not all, of 
benzylfentanyl or 4-anilinopiperidine is used for the illicit 
manufacturing of fentanyl. The primary costs associated with this 
proposed 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 the DEA and have all security and 
other handling processes in place, resulting in minimal cost.The DEA 
has identified 38 domestic suppliers of benzylfentanyl, 4-
anilinopiperidine, or both, 37 of which are not registered with the 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, the DEA believes any quantity of sales from these 
distributors for legitimate pharmaceutical fentanyl manufacturing is 
minimal. Therefore, the DEA estimates the cost of this rule on any 
affected small entity is minimal. The DEA welcomes any public comment 
regarding this estimate. Based on these factors, the DEA projects that 
this rule, if promulgated, 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, the 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 proposed action does not impose a new collection of 
information requirement under the Paperwork Reduction Act, 44 U.S.C. 
3501-3521. This proposed 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, the DEA proposes to amend 21 CFR 
part 1310 as follows:

[[Page 48320]]

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 the 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 30 days after the publication of a rule finalizing this 
action. 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 the DEA must obtain a registration 
with the DEA. A temporary exemption from the registration requirement 
will also be provided for those persons whose application for exemption 
is denied, provided that the 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 the 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 
the 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 30 days after the publication of 
a rule finalizing this action. 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 the DEA must obtain a registration with the DEA. 
A temporary exemption from the registration requirement will also be 
provided for those persons whose application for exemption is denied, 
provided that the 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 the 
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 48321]]



                                          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.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: September 6, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-19787 Filed 9-12-19; 8:45 am]
 BILLING CODE 4410-09-P