[Federal Register Volume 85, Number 75 (Friday, April 17, 2020)]
[Rules and Regulations]
[Pages 21320-21325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07381]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-496]
Control of the Immediate Precursor Norfentanyl Used in the
Illicit Manufacture of Fentanyl as a Schedule II Controlled Substance
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration (DEA) is designating the
precursor chemical, N-phenyl-N-(piperidin-4-yl)propionamide
(norfentanyl) as an immediate precursor for the schedule II controlled
substance fentanyl. Furthermore, DEA is finalizing the control of
norfentanyl as a schedule II substance under the Controlled Substances
Act (CSA).
DATES: This rulemaking becomes effective May 18, 2020.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section (DPW), Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 362-3261.
SUPPLEMENTARY INFORMATION: Norfentanyl is the immediate chemical
intermediary in a synthesis process currently used by clandestine
laboratory operators for the illicit manufacture of the schedule II
controlled substance fentanyl. The distribution of illicitly
manufactured fentanyl has caused an unprecedented outbreak of thousands
of fentanyl-related overdoses in the United States in recent years. DEA
believes that the control of norfentanyl as a schedule II controlled
substance is necessary to prevent its diversion as an immediate
chemical intermediary for the illicit manufacture of fentanyl.
DEA is extremely concerned with the recent increase in the illicit
manufacture and distribution of fentanyl. Therefore, on September 17,
2019, DEA published a Notice of Proposed Rulemaking (NPRM) to designate
the precursor chemical, N-phenyl-N-(piperidin-4-yl)propionamide
(norfentanyl), as an immediate precursor of the schedule II controlled
substance fentanyl under the definition set forth in 21 U.S.C. 802(23),
and to control it as a schedule II substance under the CSA. 84 FR
48815. This rulemaking finalizes that NPRM.
Legal Authority
Under 21 U.S.C. 811(e), the Attorney General may place an immediate
precursor into the same schedule as the controlled substance that the
immediate precursor is used to make, if the substance meets the
requirements of an immediate precursor under 21 U.S.C. 802(23).
Background
The DEA is extremely concerned with the increase in the illicit
manufacture and distribution of fentanyl abroad. Fentanyl is a
synthetic opioid and was first synthesized in Belgium in the late
1950's. Fentanyl is controlled in schedule II of the CSA due to its
high potential for abuse and dependence, and accepted medical use in
treatment in the United States. Fentanyl was introduced into medical
practice and is approved in the United States for anesthesia and
analgesia. However, due to its pharmacological effects, fentanyl can
serve as a substitute for heroin, oxycodone, and other opioids in
opioid dependent individuals. The 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
percent) involved fentanyl.\2\ Of the 63,632 drug overdose deaths in
2016, 18,335 (28.8 percent) involved fentanyl. This was the first time
that fentanyl was reported in more drug related fatalities than heroin.
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\1\ Drugs Most Frequently Involved in Drug Overdose Deaths:
United States, 2011-2016. National Vital Statistics Reports; vol 67
no 9. Hyattsville, MD: National Center for Health Statistics, 2018.
\2\ The fentanyl category includes fentanyl, fentanyl
metabolites, precursors, and analogs.
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The increase of drug overdose deaths continued into 2017. According
to the CDC,\3\ there were 70,237 drug overdose deaths in the United
States in 2017, an increase from the 63,632 overdose deaths recorded in
2016. Of the 70,237 overdose deaths in 2017, 47,600 (67.8 percent)
involved an opioid. Deaths involving prescription opioids and heroin
remained stable from 2016 to 2017; synthetic opioid overdose deaths
(other than methadone), which include deaths related to fentanyl,
increased 45.2 percent from 19,413 deaths in 2016 to 28,466 deaths in
2017.
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\3\ Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and
Opioid-Involved Overdose Deaths--United States, 2013-2017. MMWR Morb
Mortal Wkly Rep 2019;67:1419-1427.
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The increase in overdose fatalities involving fentanyl coincides
with a dramatic increase of law enforcement encounters of fentanyl.
According to the National Forensic Laboratory Information System
(NFLIS),\4\ submissions to forensic laboratories that contained
fentanyl increased exponentially beginning in 2012: 694 in 2012, 1,044
in 2013, 5,537 in 2014, 15,455 in 2015, 37,294 in 2016, 61,382 in 2017,
and 70,453 in 2018.
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\4\ The National Forensic Laboratory Information System (NFLIS)
is a national forensic laboratory reporting system that
systematically collects results from drug chemistry analyses
conducted by Federal, State and local forensic laboratories in the
United States. NFLIS data was queried on March 26, 2019.
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Role of Norfentanyl 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 for
creating a new organic molecule 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).
[[Page 21321]]
The DEA controlled NPP on April 23, 2007 as a list I chemical by
interim rule (72 FR 20039), which was finalized on July 25, 2008. 73 FR
43355. By final rule published on June 29, 2010, ANPP was controlled as
a schedule II immediate precursor to fentanyl, with an effective date
of 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 increase 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 also use other synthetic routes in response
to regulations placed on NPP and ANPP. One of these other routes is the
original published synthetic pathway to fentanyl, known as the Janssen
method, previously thought to be beyond the skills of most clandestine
laboratory operators. This synthetic route does not involve NPP or ANPP
as precursors. This synthetic pathway involves the important precursors
N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl) and N-
phenyl-N-(piperidin-4-yl)propionamide (norfentanyl). Benzylfentanyl is
converted into norfentanyl in one chemical reaction. Norfentanyl is
then subjected to one simple chemical reaction to complete the
synthesis of fentanyl. The DEA is not aware of any legitimate uses of
benzylfentanyl or norfentanyl other than in the synthesis of fentanyl.
According to DEA forensic laboratory data, the Janssen method was
confirmed as the synthetic route used in 94 percent of 85 fentanyl drug
exhibits that were evaluated to determine the synthetic route. These
exhibits were seized in 2018. In addition, the number of law
enforcement encounters of benzylfentanyl increased in 2017 and 2018. As
stated above, benzylfentanyl is a precursor chemical used to synthesize
norfentanyl in the Janssen method. According to NFLIS,\5\ there was one
identification of benzylfentanyl in 2016; however, benzylfentanyl was
identified in 195 reports in 2017 and 237 reports in 2018. This is
believed to indicate a change in the synthetic route used by some
clandestine chemists to manufacture fentanyl in efforts to evade
chemical regulations on NPP and ANPP. The increase in law enforcement
encounters coincides with the international control that placed NPP and
ANPP in Table I of the 1988 Convention in 2017.
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\5\ NFLIS data was queried on March 26, 2019.
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The DEA determined that norfentanyl is commercially available from
both domestic and foreign chemical suppliers. The DEA has identified 30
domestic suppliers and 22 foreign suppliers of norfentanyl from Canada
(3), China (7), Germany (2), Hong Kong (1), India (1), Japan (2),
Switzerland (1), and the United Kingdom (5). Of the 30 domestic
suppliers of norfentanyl, only one is a DEA registrant. As it appears
that these other 29 suppliers are not registered to manufacture
schedule II controlled substances, it is not likely these suppliers are
manufacturing fentanyl. Norfentanyl is attractive to illicit
manufacturers because of the lack of chemical regulations on this
substance, it is readily available from chemical suppliers, and it can
easily be converted to the schedule II controlled substance fentanyl,
in a one-step chemical reaction.
Designation as an Immediate Precursor
Under 21 U.S.C. 811(e), the Attorney General may place an immediate
precursor into the same schedule as the controlled substance that the
immediate precursor is used to make. The substance must meet the
requirements of an immediate precursor under 21 U.S.C. 802(23). The
term ``immediate precursor'' is defined in 21 U.S.C. 802(23) meaning a
substance being the principal compound used, or which is produced
primarily for use in the manufacture of a controlled substance; which
is an immediate chemical intermediary used or likely to be used in the
manufacture of the controlled substance; and the control of which is
necessary to prevent or limit the manufacture of such controlled
substance.
The DEA finds that norfentanyl meets the three criteria for the
definition of an immediate precursor under 21 U.S.C. 802(23). First,
DEA finds that norfentanyl is produced primarily for use in the
manufacture of the schedule II controlled substance fentanyl. As stated
in the preceding section, under the Janssen method, norfentanyl is
typically produced from the starting material benzylfentanyl and is
then subjected to a simple one-step chemical reaction to obtain the
schedule II controlled substance, fentanyl. The DEA is not aware of any
legitimate use of benzylfentanyl other than in the synthesis of
norfentanyl, and subsequently, fentanyl. The DEA has also not
identified an industrial or other use for norfentanyl beyond the
manufacture of fentanyl. DEA has not identified any other legitimate
uses of norfentanyl and DEA did not receive comment to the contrary
during the notice and comment period of the NPRM published on September
17, 2019. 84 FR 48815.
Second, DEA finds that norfentanyl is an immediate chemical
intermediary used in the manufacture of the controlled substance
fentanyl. As stated earlier, norfentanyl is produced as an intermediary
in the fentanyl synthetic pathway. After it is synthesized, norfentanyl
is subjected to a simple chemical reaction that converts it directly to
fentanyl.
Third, DEA finds that controlling norfentanyl is necessary to
prevent, curtail, and limit the unlawful manufacture of the controlled
substance, fentanyl. The DEA believes this action is necessary to
assist in preventing the possible theft of norfentanyl from legitimate
firms. The DEA believes that clandestine manufacturers will attempt to
procure unregulated chemicals in their efforts to synthesize fentanyl.
As a schedule II substance, norfentanyl will be safeguarded to the same
degree that pharmaceutical firms now safeguard the fentanyl that they
produce. Since norfentanyl is an immediate chemical intermediary in the
manufacture of fentanyl, the increased level of security is necessary
to prevent diversion of norfentanyl from legitimate firms. DEA also
believes control is necessary to prevent unscrupulous chemists from
synthesizing norfentanyl and selling it (as an unregulated material)
through the internet and other channels to individuals who may wish to
acquire an unregulated precursor for the purpose of manufacturing
fentanyl, a schedule II controlled substance.
The DEA believes that the control of norfentanyl is necessary to
prevent its production and use in the illicit manufacture of fentanyl.
Therefore, DEA is designating norfentanyl as an immediate precursor of
fentanyl, a schedule II controlled substance, pursuant to 21 U.S.C.
802(23) and 21 U.S.C. 811(e).
Placement in Schedule II--Findings Required Under CSA Immediate
Precursor Provisions
Pursuant to 21 U.S.C. 811(e), once norfentanyl is designated as an
immediate precursor under 21 U.S.C. 802(23), it may be placed directly
into schedule II (or a schedule with a higher numerical designation).
The immediate precursor provision in 21 U.S.C. 811(e)
[[Page 21322]]
permits DEA to schedule an immediate precursor ``without regard to the
findings required by'' section 811(a) or section 812(b) and ``without
regard to the procedures'' prescribed by section 811(a) and (b).
Accordingly, DEA need not address the ``factors determinative of
control'' in section 811 or the findings required for placement in
schedule II in section 812(b)(2). Based on the finding that norfentanyl
is an ``immediate precursor'' for fentanyl, DEA is hereby placing
norfentanyl directly into schedule II.
NPRM Comments
As part of the proposed rulemaking published on September 17, 2019
(84 FR 48815), DEA specifically solicited input from all potentially
affected parties regarding: (1) The types of legitimate industries
using norfentanyl; (2) the legitimate uses of norfentanyl; (3) the size
of the domestic market for norfentanyl; (4) the number of manufacturers
of norfentanyl; (5) the number of distributors of norfentanyl; (6) the
level of import and export of norfentanyl; (7) the potential burden
these proposed regulatory controls of norfentanyl may have on
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 norfentanyl by industry and others.
As part of the proposed rulemaking published on September 17, 2019
(84 FR 48815), DEA solicited information on any possible legitimate
uses of norfentanyl unrelated to fentanyl production (including
industrial uses) in order to assess the potential commercial impact of
scheduling norfentanyl. The DEA searched information in the public
domain for legitimate uses of norfentanyl and could not document
legitimate commercial uses for norfentanyl other than as an
intermediary chemical in the manufacture of fentanyl. DEA sought,
however, to document any unpublicized use(s) and other proprietary
use(s) of norfentanyl not in the public domain. Therefore, DEA
solicited comment on the uses of norfentanyl in the legitimate
marketplace. The DEA also solicited comment on the regulatory burden to
legitimate commercial activities that would result from the placement
of norfentanyl in schedule II of the CSA. The DEA did not receive
comment on these topics.
The DEA invited all interested parties to provide any information
on any legitimate uses of norfentanyl in industry, commerce, academia,
research and development, or other applications. The DEA sought both
quantitative and qualitative data; however, DEA did not receive
comments on these topics.
The DEA received 15 comments in response to the NPRM. Thirteen of
the 15 commenters were in support of controlling norfentanyl as a
schedule II immediate precursor. The other two commenters did not
specifically object to this rule. One of those two commenters stated
that substance abuse is a public health issue and not a law enforcement
issue. The other stated that this rule is not sufficient to disrupt the
fentanyl market in the United States because illicit fentanyl is not
produced in the United States. The commenter proposed access
restriction and harm reduction strategies, including increased public
awareness of drugs mixed with fentanyl and increased law enforcement at
entry locations, as additional recommendations to reduce fentanyl
misuse and abuse in the United States.
Of the 13 commenters in support of controlling norfentanyl as a
schedule II immediate precursor, four commenters also included
statements that the control of norfentanyl is not the only solution to
address the opioid epidemic. These commenters stated that control of
norfentanyl will not solve the issue of fentanyl being shipped into our
country from foreign producers; that control of norfentanyl is not the
only policy that should be addressed and implemented, and that
alternate pathways to fentanyl should be monitored; and that control of
norfentanyl will not end the opioid epidemic.
DEA response: The DEA appreciates the comments in support of
controlling norfentanyl as a schedule II immediate precursor. The DEA
is concerned with the abuse of illicitly manufactured fentanyl in the
United States and abroad. While DEA remains aware that a comprehensive
approach, to include community outreach and education, is required to
combat the opioid epidemic, DEA believes that supply reduction
strategies, which this rule attempts to address, are important aspects
to reduce drug abuse in the United States. The control of norfentanyl
as a schedule II immediate precursor is one aspect of the overall
effort to combat the opioid epidemic. The DEA believes this rule will
have a significant effect on reducing the supply of illicitly
manufactured fentanyl.
With respect to the comments about illicit fentanyl being
manufactured outside of the United States and shipped into the country
from foreign producers, the designation of norfentanyl as a schedule II
immediate precursor will subject this substance to the regulatory
requirements of schedule II substances, including the import and export
regulations. 21 CFR part 1312. The DEA believes that regulating the
import and export of norfentanyl will reduce the quantity of
norfentanyl destined to illicit fentanyl manufacturers, both
domestically and internationally, by removing the United States as a
transshipment point and as a source of diverted norfentanyl to foreign
illicit fentanyl manufacturers.
The DEA is the leading agency on enforcement of drug control laws
and remains committed to protecting the public by interrupting and
reducing drug supply and availability in the United States. The DEA
believes that the control of norfentanyl as an immediate precursor of
the schedule II controlled substance fentanyl will have a significant
impact on reducing the supply of illicitly manufactured fentanyl;
however, DEA remains aware that supply reduction is not the only aspect
of combatting the opioid epidemic. The DEA realizes that a
comprehensive approach, to include community outreach and education, is
required to combat the opioid epidemic. In response to the comment
regarding access restriction and harm reduction strategies and the
comment stating that substance abuse is a public health issue and not a
law enforcement issue, DEA intends this scheduling action to reduce the
supply of illicitly manufactured fentanyl, which is part of a multi-
faceted strategy to combat the opioid epidemic. DEA continues to work
with other federal agencies on holistic and comprehensive approaches to
reduce drug abuse; however, such approaches are beyond the scope of
this rule.
Requirements for Handling Norfentanyl
This rulemaking finalizes two actions. It (1) designates
norfentanyl as an immediate precursor for the schedule II controlled
substance, fentanyl, under the definition set forth in 21 U.S.C.
802(23); and (2) controls norfentanyl as a schedule II substance
pursuant to the authority in 21 U.S.C. 811(e).
The scheduling of norfentanyl as an immediate precursor of the
schedule II controlled substance, fentanyl, subjects norfentanyl to all
of the regulatory controls and administrative, civil, and criminal
sanctions applicable to the manufacture, distribution, dispensing,
importing, and exporting of a schedule II controlled substance. The
regulatory requirements will include the following:
[[Page 21323]]
1. Registration. Any person who manufactures, distributes,
dispenses, imports, or exports norfentanyl, engages in research with
respect to norfentanyl, or proposes to engage in such activities will
be required to submit an application and be accepted for schedule II
registration in accordance with 21 CFR part 1301.
2. Security. Norfentanyl will be subject to schedule II security
requirements. In order to prevent diversion, norfentanyl will be
manufactured, distributed, and stored in accordance with the standards
for physical security and the operating procedures set forth in 21 CFR
1301.71, 1301.72(a), (c), and (d), 1301.73, 1301.74, 1301.75(b),(c),
and (d) 1301.76, and 1301.77.
3. Labeling and Packaging. All labels and labeling for commercial
containers of norfentanyl that are distributed will be required to
comply with the requirements of 21 CFR 1302.03-1302.07.
4. Quotas. Quotas for norfentanyl will be established pursuant to
21 CFR part 1303.
5. Inventory. Every registrant who possesses any quantity of
norfentanyl will be required to keep an inventory of all stocks of the
substance on hand pursuant to 21 CFR 1304.03, 1304.04 and 1304.11.
6. Records and Reports. Every DEA registrant will be required to
maintain records and submit reports with respect to norfentanyl
pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and
1312.
7. Order Forms. Every DEA registrant who distributes norfentanyl
will be required to comply with the order form requirements pursuant to
21 U.S.C. 828 and in accordance with 21 CFR part 1305.
8. Importation and Exportation. All importation and exportation of
norfentanyl will be required to be in compliance with 21 U.S.C. 952,
953, 957, and 958, and in accordance with 21 CFR part 1312.
9. 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 controlled substance 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.
10. Liability. Any activity with norfentanyl in violation of or not
authorized under the Controlled Substances Act or the Controlled
Substances Import and Export Act will be unlawful and potentially
subject to criminal penalties. 21 U.S.C. 841-863 and 959-964.
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 rulemaking 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, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities; (2) create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order. DEA has determined that this rule is not a
``significant regulatory action'' under Executive Order 12866, section
3(f). Executive Order 13771 requires an agency, unless prohibited by
law, to identify at least two existing regulations to be repealed when
the agency publicly proposes for notice and comment or otherwise
promulgates a new regulation.\6\ In furtherance of this requirement,
Executive Order 13771 requires that the new incremental costs
associated with new regulations, to the extent permitted by law, be
offset by the elimination of existing costs associated with at least
two prior regulations.\7\ According to guidance provided by OMB, the
requirements of Executive Order 13771 only apply to each new
``significant regulatory action that . . . imposes costs.'' \8\ This
rule is not expected to be an Executive Order 13771 regulatory action
because this rule is not significant under Executive Order 12866.
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\6\ Sec. 2(a).
\7\ Sec. 2(c).
\8\ OMB Guidance Implementing Executive Order 13771 titled
``Reducing Regulation and Controlling Regulatory Costs'' (April 5,
2017).
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The scheduling of norfentanyl as an immediate precursor of the
schedule II controlled substance, fentanyl, subjects norfentanyl to all
of the regulatory controls and administrative, civil, and criminal
sanctions applicable to the manufacture, distribution, dispensing,
importing, and exporting of a schedule II controlled substance.
Norfentanyl is the immediate chemical intermediary in a synthesis
process currently used by clandestine laboratory operators for the
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 industrial use for norfentanyl,
other than its role as an intermediary chemical in the manufacture of
fentanyl. Based on the review of import and quota information for ANPP
and fentanyl, DEA believes the vast majority, if not all, of legitimate
pharmaceutical fentanyl is produced from ANPP (schedule II immediate
precursor for fentanyl), not norfentanyl. The quantities of ANPP
permitted in the U.S., imported or manufactured pursuant to a quota,
generally correspond with the quantities of legitimate pharmaceutical
fentanyl produced in the United States. Additionally, DEA is not aware
of norfentanyl being used for the manufacturing of legitimate
pharmaceutical fentanyl; however, DEA cannot rule out the possibility
that minimal quantities of norfentanyl are used for this purpose. If
there are any quantities of norfentanyl used for the manufacturing of
legitimate pharmaceutical fentanyl, the quantities are believed to be
small and economically insignificant.
The DEA evaluated the costs and benefits of this action.
[[Page 21324]]
Costs
The DEA believes the market for norfentanyl for the legitimate
manufacturing of pharmaceutical fentanyl is minimal. As stated above,
the only use for norfentanyl of which DEA is aware is for the
manufacturing of fentanyl. Any manufacturer, distributor, importer, or
exporter of norfentanyl for the production of legitimate pharmaceutical
fentanyl, if they exist at all, would incur costs. The primary costs
associated with this rule include costs associated with complying with
registration, physical security, labeling and packaging, quota,
inventory, recordkeeping and reporting, and importation and exportation
requirements. Other than the annual registration fees ($3,047 for
manufacturers and $1,523 for distributors, importers, and exporters),
due to the many unknowns and variability between entities, it is highly
difficult to quantify the potential total cost burden of this
regulation. However, any manufacturer that uses norfentanyl for
legitimate pharmaceutical fentanyl production would already be
registered with DEA and have all security and other handling processes
in place, resulting in minimal cost. Any lost sales or profit
attributed to those manufacturers or suppliers that are not for
legitimate pharmaceutical fentanyl are excluded from the analysis as
they are, whether passively or actively, facilitating the manufacture
of illicit fentanyl.
The DEA has identified 30 domestic suppliers of norfentanyl, 29 of
which are not registered with DEA to handle schedule II controlled
substances. It is difficult to estimate how much norfentanyl 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
fentanyl and ANPP, where the quantities of ANPP imported and
manufactured generally correspond with the quantities of fentanyl
produced, DEA believes any quantity of sales from these distributors
for the legitimate pharmaceutical fentanyl manufacturing is minimal.
Suppliers for the legitimate use of norfentanyl are expected to choose
the least-cost option, and stop selling the minimal quantities, if any,
of norfentanyl, rather than incur the costs of complying with the
regulatory requirements. Because DEA believes the quantities of
norfentanyl supplied for the legitimate manufacturing of pharmaceutical
fentanyl is minimal, DEA estimates that the cost of foregone sales is
minimal; and thus, the cost of this rule is minimal.
This analysis excludes consideration of economic impact to those
businesses that facilitate the manufacturing and distribution of
norfentanyl for the manufacture of illicit fentanyl. The only use for
norfentanyl of which DEA is currently aware is the manufacture of
fentanyl. Although these suppliers are selling a currently unregulated
substance, they wittingly or unwittingly facilitate the manufacturing
of illicit fentanyl. As a law enforcement organization and as a matter
of principle, DEA believes considering the economic utility of
facilitating the manufacture of illicit fentanyl would be improper.
Benefits
Controlling norfentanyl is expected to prevent, curtail, and limit
the unlawful manufacture and distribution of the controlled substance,
fentanyl. This action is also expected to assist preventing the
possible theft or diversion of norfentanyl from any legitimate firms.
As a schedule II substance, norfentanyl will be safeguarded to the same
degree that pharmaceutical firms now safeguard the fentanyl that they
produce. The DEA also believes control is necessary to prevent
unscrupulous chemists from synthesizing norfentanyl and selling it (as
an unregulated material) through the internet and other channels, to
individuals who may wish to acquire an unregulated precursor for the
purpose of manufacturing illicit fentanyl.
In summary, DEA conducted a qualitative analysis of costs and
benefits. DEA believes this action will minimize the diversion of
norfentanyl. The DEA believes the market for norfentanyl for the
legitimate manufacturing of pharmaceutical fentanyl is minimal.
Therefore, any potential cost as a result of this regulation is
minimal. Therefore, the estimated economic impact of this rule is less
than $100 million in any given year.
Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform
to eliminate drafting errors and ambiguity, minimize litigation,
provide a clear legal standard for affected conduct, and promote
simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of Executive Order 13132. The rule does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or the distribution of power
and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of Executive Order 13175. This rule does not have
substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes.
Regulatory Flexibility Act
The Acting Administrator, in accordance with the Regulatory
Flexibility Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by
approving it certifies that it will not have a significant economic
impact on a substantial number of small entities. As discussed above,
the scheduling of norfentanyl as an immediate precursor of the schedule
II controlled substance, fentanyl, subjects norfentanyl to all of the
regulatory controls and administrative, civil, and criminal sanctions
applicable to the manufacture, distribution, dispensing, importing, and
exporting of a schedule II controlled substance. Norfentanyl is the
immediate chemical intermediary in a synthesis process currently used
by clandestine laboratory operators for 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 use for norfentanyl, other than its
role as an intermediary chemical in the manufacture of fentanyl. Based
on the review of import and quota information for ANPP and fentanyl,
DEA believes the vast majority, if not all, of legitimate
pharmaceutical fentanyl is produced from ANPP (schedule II immediate
precursor for fentanyl), not norfentanyl. The quantities of ANPP
permitted in the U.S., imported or manufactured pursuant to a quota,
generally correspond with the quantities of
[[Page 21325]]
legitimate pharmaceutical fentanyl produced in the United States.
Additionally, DEA is not aware of norfentanyl being used for the
manufacturing of legitimate pharmaceutical fentanyl; however, DEA
cannot rule out the possibility that minimal quantities of norfentanyl
are used for this purpose. If there are any quantities of norfentanyl
used for the manufacturing of legitimate pharmaceutical fentanyl, the
quantities are believed to be small and economically insignificant.
The DEA has identified 30 domestic suppliers of norfentanyl. Based
on the Small Business Administration size standard for chemical
distributors and Statistics of United States Business data, 94.5
percent or 28.4 (rounded to 28) are estimated to be small entities. It
is difficult to know how much norfentanyl 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 fentanyl and
ANPP, where the quantities of ANPP imported and manufactured generally
correspond with the quantities of fentanyl produced, DEA believes any
quantity of sales from these distributors for the legitimate
pharmaceutical fentanyl manufacturing is minimal. Therefore, DEA
estimates the cost of this rule on any affected small entity is
minimal.
Because of these facts, this rule will not result in a significant
economic impact on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
On the basis of information contained in the ``Regulatory
Flexibility Act'' section above, DEA determined and certifies pursuant
to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et
seq., that this action will not result in any Federal mandate that may
result ``in the expenditure by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100,000,000 or more
(adjusted for inflation) in any one year * * *.'' Therefore, neither a
Small Government Agency Plan nor any other action is required under
provisions of UMRA.
Paperwork Reduction Act
This action does not impose a new collection of information under
the Paperwork Reduction Act, 44 U.S.C. 3501-3521. This action does 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 1308
Administrative practice and procedure, drug traffic control,
reporting and recordkeeping requirements.
For the reasons set out above, DEA amends 21 CFR part 1308 as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. Amend Sec. 1308.12 by adding paragraph (g)(3)(ii) to read as
follows.
Sec. 1308.12 Schedule II.
* * * * *
(g) * * *
(3) * * *
(ii) N-phenyl-N-(piperidin-4-yl)propionamide 8366
(norfentanyl).
* * * * *
Dated: March 5, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-07381 Filed 4-16-20; 8:45 am]
BILLING CODE 4410-09-P