Designation of Benzylfentanyl and 4-Anilinopiperidine, Precursor Chemicals Used in the Illicit Manufacture of Fentanyl, as List I Chemicals
| Published date | 13 September 2019 |
| Citation | 84 FR 48314 |
| Record Number | 2019-19787 |
| Section | Proposed rules |
| Court | Drug Enforcement Administration |
Federal Register, Volume 84 Issue 178 (Friday, September 13, 2019)
[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
