Control of the Immediate Precursor Norfentanyl Used in the Illicit Manufacture of Fentanyl as a Schedule II Controlled Substance
| Published date | 17 September 2019 |
| Record Number | 2019-19786 |
| Section | Proposed rules |
| Court | Drug Enforcement Administration |
Federal Register, Volume 84 Issue 180 (Tuesday, September 17, 2019)
[Federal Register Volume 84, Number 180 (Tuesday, September 17, 2019)]
[Proposed Rules]
[Pages 48815-48820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19786]
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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: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration (DEA) proposes to
designate the precursor chemical, N-phenyl-N-(piperidin-4-
yl)propionamide (norfentanyl) as an immediate precursor for the
schedule II controlled substance fentanyl. Furthermore, the DEA
proposes to control norfentanyl as a schedule II substance under the
Controlled Substances Act (CSA). 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 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 production of fentanyl.
DATES: Comments must be submitted electronically or postmarked on or
before November 18, 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-496'' 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 the
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
[[Page 48816]]
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
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. 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%)
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 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%) 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 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, the 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 by 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. (June
29, 2010).
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,
which is subject to a Notice of Proposed Rulemaking for control as a
list I chemical published elsewhere in this issue of the Federal
Register, is converted into norfentanyl in one chemical reaction.
Norfentanyl is
[[Page 48817]]
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% 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'' as defined in 21 U.S.C. 802(23) means a
substance:
(A) which the Attorney General has found to be and by regulation
designated as being the principal compound used, or produced primarily
for use, in the manufacture of a controlled substance;
(B) which is an immediate chemical intermediary used or likely to
be used in the manufacture of such controlled substance; and
(C) the control of which is necessary to prevent, curtail, 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,
the 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. Although DEA has not identified any other
legitimate uses of norfentanyl, this notice of proposed rulemaking
provides the public an opportunity to provide information to the
contrary, as described in the ``Solicitation for Information'' section
below.
Second, the 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, the 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 effort 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. 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
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 production of fentanyl.
Therefore, the DEA is proposing the designation of 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).
Proposed 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) permits the 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, the
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, the DEA proposes to place
norfentanyl directly into schedule II.
Requirements for Handling Norfentanyl
The proposed scheduling of norfentanyl as an immediate precursor of
the schedule II controlled substance, fentanyl, would subject
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. If norfentanyl is placed in schedule II, the
regulatory requirements will include the following:
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 would
be required to submit an application and be accepted for
[[Page 48818]]
schedule II registration in accordance with 21 CFR part 1301.
2. Security. Norfentanyl would be subject to schedule II security
requirements. In order to prevent diversion, norfentanyl would have to
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) and (c), 1301.76, and 1301.77.
3. Labeling and Packaging. All labels and labeling for commercial
containers of norfentanyl that are distributed would be required to
comply with the requirements of 21 CFR 1302.03-1302.07.
4. Quotas. Quotas for norfentanyl would be established pursuant to
21 CFR part 1303.
5. Inventory. Every registrant who possesses any quantity of
norfentanyl would 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 would 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
would 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 would 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. Liability. Any activity with norfentanyl in violation of or not
authorized under the Controlled Substances Act or the Controlled
Substances Import and Export Act would be unlawful and potentially
subject to criminal penalties (21 U.S.C. 841-863 and 959-964).
Solicitation for Information
As part of this proposed rulemaking, the DEA is soliciting
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 has
searched information in the public domain for legitimate uses of
norfentanyl and has not documented legitimate commercial uses for
norfentanyl other than as an intermediary chemical in the production of
fentanyl. The DEA seeks, however, to document any unpublicized use(s)
and other proprietary use(s) of norfentanyl not in the public domain.
Therefore, the DEA is soliciting comment on the uses of norfentanyl in
the legitimate marketplace. DEA is also soliciting comment on the
regulatory burden to legitimate commercial activities that would result
from the proposed placement of norfentanyl in schedule II of the CSA.
The DEA is soliciting 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. The
DEA invites 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 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, 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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The scheduling of norfentanyl as an immediate precursor of the
schedule II controlled substance, fentanyl, would subject norfentanyl
to all of the regulatory controls and administrative, civil, and
criminal sanctions applicable to the manufacture, distribution,
[[Page 48819]]
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 production of fentanyl. Based
on the review of import and quota information for ANPP and fentanyl,
the 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 U.S. Additionally, the DEA is not aware of
norfentanyl being used for the manufacturing of legitimate
pharmaceutical fentanyl; however, the 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 proposed action.
Costs
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 the 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 if this proposed rule
were finalized. The primary costs associated with this proposed 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 proposed regulation. However, any
manufacturer that uses norfentanyl 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. 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 the 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, the DEA believes any quantity of sales from these
distributors for the legitimate pharmaceutical fentanyl manufacturing
is minimal. If this proposed rule is finalized, 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 the DEA believes the quantities of
norfentanyl supplied for the legitimate manufacturing of pharmaceutical
fentanyl is 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 economic impact to those
businesses that facilitate the manufacturing and distribution of
norfentanyl for the production of manufacturing illicit fentanyl. The
only use for norfentanyl of which the DEA is currently aware is the
production 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, the 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 would 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, the DEA conducted a qualitative analysis of costs and
benefits. The DEA believes this action, if finalized, 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 proposed rule
is less than $100 million in any given year.
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
[[Page 48820]]
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, the proposed scheduling of norfentanyl as an immediate precursor
of the schedule II controlled substance, fentanyl, would subject
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 production of fentanyl. Based
on the review of import and quota information for ANPP and fentanyl,
the 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 U.S. Additionally, the DEA is not aware of
norfentanyl being used for the manufacturing of legitimate
pharmaceutical fentanyl; however, the 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 Small Business Administration size standard for chemical
distributors and Statistics of U.S. Business data, 94.5% 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, the DEA believes any quantity of
sales from these distributors for the 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.
Because of these facts, this proposed rule will not, if
promulgated, 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 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 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 1308
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 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 a new paragraph (g)(3)(ii) and adding
and reserving paragraph (g)(3)(iii) to read as follows.
Sec. 1308.12 Schedule II.
* * * * *
(g) * * *
(3) * * *
(ii) N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl)--8366
(iii) [Reserved]
* * * * *
Dated: September 6, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-19786 Filed 9-16-19; 8:45 am]
BILLING CODE 4410-09-P
