[Federal Register: April 23, 2007 (Volume 72, Number 77)]
[Rules and Regulations]
[Page 20039-20047]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ap07-5]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-299I]
RIN 1117-AB12
Control of a Chemical Precursor Used in the Illicit Manufacture
of Fentanyl as a List I Chemical
AGENCY: Drug Enforcement Administration (DEA), U.S. Department of
Justice.
ACTION: Interim rule with request for comments.
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SUMMARY: This rulemaking controls the chemical N-phenethyl-4-piperidone
(NPP) as a List I chemical under the Controlled Substances Act (CSA)
(21 U.S.C. 801 et seq.). Clandestine laboratories are using this
chemical to illicitly manufacture the schedule II controlled substance
fentanyl.
The recent distribution of illicitly manufactured fentanyl has
caused an unprecedented outbreak of hundreds of suspected fentanyl-
related overdoses, at least 972 confirmed fentanyl-related deaths, and
162 suspected fentanyl-related deaths occurring mostly in Delaware,
Illinois, Maryland, Michigan, Missouri, New Jersey, and Pennsylvania.
NPP has been identified as the starting material in several seized
fentanyl clandestine laboratories. In addition to DEA's concern
regarding the deaths associated with illicitly manufactured fentanyl,
DEA is extremely concerned about the safety of law enforcement officers
encountering these clandestine laboratories. Therefore, DEA is
regulating NPP as a List I chemical through this Interim Rulemaking.
DEA is soliciting comments on this Interim Rule.
This rulemaking will subject handlers of NPP to the chemical
regulatory provisions of the CSA and its implementing regulations,
including 21 CFR Parts 1309, 1310, 1313, and 1316. This rulemaking does
not establish a threshold for domestic and international transactions
of NPP. As such, all transactions involving NPP, regardless of size,
shall be regulated. This rulemaking also specifies that chemical
mixtures containing NPP will not be exempt from regulatory requirements
at any concentration. Therefore, all transactions of chemical mixtures
containing any quantity of NPP will be regulated and will be subject to
control under the CSA.
DATES: This rulemaking will become effective on April 23, 2007. Persons
seeking registration must apply on or before June 22, 2007 to continue
their business pending final action by DEA on their application.
Written comments must be postmarked, and electronic comments must
be sent on or before June 22, 2007.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-299I'' on all written and electronic correspondence.
Written comments via regular mail should be sent to the Deputy
Assistant Administrator, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, Attention: DEA Federal Register
Representative/ODL. Written comments sent via express mail should be
sent to DEA Headquarters, Attention: DEA Federal Register
Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301.
Comments may be sent directly to DEA electronically by sending an
electronic message to dea.diversion.policy@usdoj.gov. Comments may also
be sent electronically through http://www.regulations.gov using the
electronic comment form provided on that site. An electronic copy of
this document is also available at the http://www.regulations.gov Web
site. DEA will accept attachments to electronic comments in Microsoft
word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not
accept any file formats other than those specifically listed here.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537 at (202) 307-7183.
SUPPLEMENTARY INFORMATION:
Background
The DEA is extremely concerned with the increase in the illicit
manufacture and distribution of fentanyl, which has resulted in
hundreds of fentanyl-related overdoses and fentanyl-related deaths
across the country. Fentanyl is a schedule II controlled substance.
Fentanyl and analogues of fentanyl are the most potent opioids
available for human and veterinary use. Fentanyl produces opioid
effects that are indistinguishable from morphine or heroin. However,
fentanyl has a greater potency and a shorter duration of action.
Fentanyl is approximately 50 to 100 times more potent than morphine and
30 to 50 times more potent than heroin depending on the physiological
or behavioral endpoints being measured, the route of administration,
and other factors.
The legitimate medical use of fentanyl is for anesthesia and
analgesia, but fentanyl's euphoric effects are highly sought after by
narcotic addicts. Fentanyl can serve as a direct pharmacological
substitute for heroin in opioid dependent individuals. However,
fentanyl is a very dangerous substitute for heroin because the amount
that produces a euphoric effect also induces respiratory depression.
Furthermore, due to fentanyl's increased potency over heroin, illicit
drug dealers have trouble adjusting (``cutting'') pure fentanyl into
proper dosage concentrations. As a result, unsuspecting heroin users or
heroin users who know the substance contains fentanyl have difficulty
determining how much to take to get their ``high'' and mistakenly take
a lethal quantity of the fentanyl. Unfortunately, only a slight excess
in the amount of fentanyl taken can be, and is often, lethal because
the resulting level of respiratory depression is sufficient to cause
the user to stop breathing.
In April 2006, DEA issued an officer safety alert regarding the
special precautions that must be observed when handling and processing
suspected fentanyl. DEA is concerned with the unusual health hazards
posed to law enforcement officers and forensic chemists from exposure
to high purity fentanyl during law enforcement operations. Since high
purity fentanyl can be fatal if sub-milligram quantities are
accidentally swallowed, inhaled, or absorbed through the skin, the
potential for lethal fentanyl exposure to law enforcement officers
exists during raids of fentanyl clandestine laboratories, during
seizures of drug exhibits, and during subsequent testing of pure
fentanyl in the forensic laboratories. The
[[Page 20040]]
primary lethal exposure routes from high purity fentanyl are the
following: accidental inhalation of airborne fentanyl powder;
accidental transfer of fentanyl powder/liquid from contaminated hands/
gloves that inadvertently touch the mouth, nose, or other mucous
membranes; and accidental transfer through cuts in the skin or roughly
abraded skin.
Illicit Manufacture of Fentanyl
DEA has determined from the forensic testing of seized illicit
fentanyl that both the Janssen synthesis route and the Siegfried method
are being used to clandestinely produce fentanyl. In 1965, Janssen
Pharmaceutical patented the original synthesis procedure for fentanyl,
which used n-benzyl-4-piperidone as the starting material. The Janssen
synthesis route is difficult to perform and is beyond the rudimentary
skills of most clandestine laboratory operators. Only individuals who
have acquired advanced chemistry knowledge and skills have successfully
used this synthesis route. Forensic laboratories can determine whether
fentanyl was manufactured illicitly by the Janssen route by detecting
the impurity benzylfentanyl in the tested fentanyl drug exhibit.
In the early 1980s, an alternate fentanyl synthesis route was
published in the scientific literature that uses NPP as the starting
material. The Chemical Abstracts Service Registry Number \1\ (CASRN)
for NPP is 39742-60-4. The NPP synthesis route is described on the
Internet and is referred to as the Siegfried method. The detection of
the impurity 4-anilino-N-phenethyl-4-piperidine (ANPP) without the
presence of benzylfentanyl in the fentanyl drug exhibit suggests that
the fentanyl was manufactured by the Siegfried method (i.e., a small
amount of ANPP is not consumed in the last reaction in the synthesis
and a trace amount of ANPP can be found in the illicit fentanyl
produced).
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\1\ The Chemical Abstracts Service Registry Number (CASRN) is
created by the Chemical Abstracts Service (CAS) Division of the
American Chemical Society and is part of an automated information
system housing data and information on specific, definable chemical
substances. The CAS registry number provides consistent and
unambiguous identification of chemicals and facilitates sharing of
chemical information.
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Since 2000, four of the five domestic fentanyl clandestine
laboratories seized by law enforcement have used the Siegfried method
or a modified version of the Siegfried method to manufacture the
illicit fentanyl. From these four domestic clandestine laboratories,
about 800 grams equivalent of pure fentanyl were seized. Furthermore,
enough of the unused NPP precursor chemical was also seized to make an
additional 5,000 grams of pure fentanyl. Therefore, from the amount of
illicit fentanyl and precursor chemicals found at these four domestic
fentanyl laboratories using the Seigfried method or modified Seigfried
method, the laboratories could have potentially generated a total of
5,800 grams of illicit fentanyl. Since fentanyl is potent in sub-
milligram quantities, the subsequent ``cutting'' of 5,800 grams of
illicit fentanyl would be sufficient to make about 46 million fentanyl
doses.
Three of the domestic fentanyl clandestine laboratories seized by
law enforcement are known to have obtained the NPP precursor chemical
from domestic suppliers. This rule will make the purchase of NPP from
domestic or international suppliers a regulated transaction. In this
way, DEA will be informed of the sale of NPP and can take appropriate
action, if necessary. Thus, DEA is regulating the chemical NPP as a
List I chemical under the CSA (21 U.S.C. 801 et seq.). Furthermore,
under 21 U.S.C 811(e) of the CSA, DEA also intends to control ANPP as a
schedule II immediate precursor to fentanyl under a separate
rulemaking.
Illicit Fentanyl-Related Deaths
DEA has seen a recent increase in the illicit manufacture of
fentanyl. In just the last three years, a total of four domestic
fentanyl clandestine laboratories have been seized. Furthermore, in
2006, DEA saw a sharp increase in the seizures of illicit fentanyl. Law
enforcement seized a one kilogram package of high purity illicitly-
manufactured fentanyl hydrochloride in California, a variety of illicit
tablets containing fentanyl whose appearance is designed to mimic
Ecstasy and OxyContin[supreg] tablets, and various mixtures of
illicitly-manufactured fentanyl powders combined with heroin or cocaine
from locations across the United States.
The distribution of illicit fentanyl or illicit fentanyl combined
with heroin or cocaine (i.e., a ``speedball'') has resulted in an
outbreak of hundreds of suspected fentanyl-related overdoses, at least
972 confirmed fentanyl-related deaths, and 162 suspected fentanyl-
related deaths occurring mostly in Delaware, Illinois, Maryland,
Michigan, Missouri, New Jersey, and Pennsylvania according to the
Centers for Disease Control and Prevention (CDC) and local medical
examiners. DEA terms fentanyl-related deaths ``suspected'' until
confirmed through the completion of an autopsy, a positive
toxicological testing result for fentanyl in the blood, and the
reporting of the death to the DEA.
Confirmed illicit fentanyl-related deaths have been reported to the
DEA for the following six jurisdictions: Philadelphia, Pennsylvania;
Cook County, Illinois; Wayne County, Michigan; St. Louis County,
Missouri; the entire state of New Jersey, and the entire state of
Delaware. Between April 13, 2006, and September 27, 2006, the
Philadelphia Medical Examiner's Office confirmed 179 fentanyl-related
deaths. Between April 18, 2005, and November 9, 2006, the Chief Medical
Examiner of Cook County, Illinois confirmed 314 fentanyl-related deaths
in the city of Chicago and its suburbs. Between August 27, 2005, and
December 31, 2006, the Wayne County Medical Examiner confirmed 230
fentanyl-related deaths in the city of Detroit and the surrounding
county. Between August 16, 2005, and August 28, 2006, the St. Louis
Medical Examiner confirmed 33 fentanyl-related deaths in St. Louis
County. Between January 25, 2006, and September 21, 2006, the New
Jersey Department of Health confirmed 86 fentanyl-related deaths in the
entire State of New Jersey. Between April 20, 2006, and September 2,
2006, the Chief Medical Examiner for Wilmington, Delaware, confirmed 19
fentanyl-related deaths in the entire state of Delaware. Since
autopsies and toxicological testing for fentanyl take several weeks to
complete and report, the above medical examiner reports represent the
most current information regarding confirmed deaths linked to fentanyl
available to DEA.
The graph below shows the monthly rate of fentanyl-related deaths
in the city of Chicago and its suburbs (Cook County, Illinois) through
the beginning of November 2006. The rapid onset of the illicit fentanyl
outbreak can be observed in the graph.
BILLING CODE 4410-09-P
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[GRAPHIC] [TIFF OMITTED] TR23AP07.003
BILLING CODE 4410-09-C?>
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Beyond these 972 confirmed fentanyl-related deaths in the six
jurisdictions outlined above, other areas of the country have also been
significantly impacted by this problem. There are 162 suspected
fentanyl-related deaths in these areas:
Grundy County, Illinois.
Macomb, Oakland & Genesee Counties of Michigan.
Rest of Pennsylvania.
Maryland, Massachusetts, Virginia, New Hampshire, Maine,
Kentucky, and Ohio.
From the information and data collected, there is a strong
indication that the fentanyl in these confirmed and suspected fentanyl-
related deaths is illicitly manufactured rather than diverted from
legal pharmaceutical manufacturers. Deaths related to fentanyl
pharmaceutical products were eliminated from the fentanyl-related
deaths reported to the DEA by both the Cook County and Philadelphia
medical examiners. Furthermore, forensic testing of seized fentanyl
drug exhibits has identified the illicit fentanyl impurities
benzylfentanyl and/or ANPP in the majority of these exhibits. The
current forensic data suggests that most of these fentanyl-related
deaths are from fentanyl illicitly manufactured by the Siegfried method
using NPP.
Availability of the Precursor Chemical
DEA has determined that the precursor chemical, NPP, is readily
available from commercial chemical suppliers. DEA has identified at
least 62 suppliers of NPP, of which 14 are located domestically and 48
are located internationally in Germany, India, and China. Since 2000,
law enforcement has evidence to support that the NPP precursor chemical
was obtained from domestic suppliers for three domestic fentanyl
clandestine laboratories. Furthermore, a fentanyl clandestine
laboratory in Mexico is believed to have obtained the NPP precursor
chemical from an international supplier. Law enforcement has identified
four separate chemical suppliers that have distributed NPP to illicit
fentanyl clandestine laboratories. This rule will make the domestic
sale of NPP a regulated transaction. This rule will also make the
importation of NPP from an international supplier a regulated
transaction. Documenting the domestic sale and importation of NPP is
needed by law enforcement to identify the domestic diversion of NPP for
the illicit manufacture of fentanyl in the United States.
Regulation of NPP as a List I Chemical
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. NPP is being used by clandestine laboratories as the starting
material for the illicit manufacture of fentanyl. This interim rule
regulates NPP as a List I chemical because DEA finds that NPP is used
in the illicit manufacture of the controlled substance fentanyl and is
important to the illicit manufacture of the controlled substance
fentanyl.
Handlers of NPP will become subject to the chemical regulatory
provisions of the CSA, including 21 CFR Parts 1309, 1310, 1313, and
1316. This rulemaking does not establish a threshold for domestic and
import transactions of NPP pursuant to the provisions of 21 CFR
1310.04(g). Due to the high potency of fentanyl, even a single gram
(i.e., 1/28th of an ounce) of NPP can be used illicitly to make about
7,750 dosage units of fentanyl. Therefore, all NPP transactions
regardless of size shall be regulated transactions as defined in 21 CFR
1300.02(b)(28). As such, all NPP transactions will be subject to
recordkeeping, annual manufacturer reporting of inventory and use data,
import/export controls, and other CSA chemical regulatory requirements.
Chemical Mixtures of NPP
This rulemaking also specifies that chemical mixtures containing
NPP will not be exempt from regulatory requirements at any
concentration, unless an application for exemption of a chemical
mixture is submitted by a NPP manufacturer and the application is
reviewed and accepted by the DEA under 21 CFR 1310.13 (Exemption by
Application Process). Since even a small amount of NPP is able to make
a significant amount of fentanyl, the control of chemical mixtures
containing any amount of NPP is necessary to prevent the illicit
extraction, isolation, and use of the NPP. Therefore, all chemical
mixtures containing any quantity of NPP will be subject to CSA control,
unless the NPP manufacturer is granted an exemption by the application
process discussed below. This interim rule modifies the Table of
Concentration Limits in 21 CFR 1310.12(c) to reflect the fact that
chemical mixtures containing any amount of NPP are subject to CSA
chemical control provisions.
Exemption by Application Process
DEA has implemented an application process to exempt mixtures from
the requirements of the CSA and its implementing regulations (21 CFR
1310.13). This application process was finalized in the Final Rule (68
FR 23195) published May 1, 2003. Under the application process,
manufacturers may submit an application for exemption for those
mixtures that do not qualify for automatic exemption. Exemption status
can be granted if DEA determines that the mixture is formulated in such
a way that it cannot be easily used in the illicit production of a
controlled substance and that the listed chemical cannot be readily
recovered (i.e., it meets the conditions in 21 U.S.C. 802(39)(A)(vi)).
Requirements for Handling List I Chemicals
The designation of NPP as a List I chemical will subject NPP
handlers to all of the regulatory controls and administrative, civil,
and criminal sanctions applicable to the manufacture, distribution,
importing, and exporting of a List I chemical. Persons potentially
handling NPP, including regulated chemical mixtures containing NPP,
will be required to comply with the following List I chemical
regulations:
1. Registration. Any person who manufactures or distributes a List
I chemical, or proposes to engage in the manufacture or distribution of
a List I chemical, must obtain a registration pursuant to the CSA (21
U.S.C. 822). Regulations describing registration for List I chemical
handlers are set forth in 21 CFR Part 1309.
Consistent with 21 CFR Parts 1309 and 1310, separate registrations
will be required for manufacturing, distribution, importing, and
exporting of NPP. Different locations operated by a single entity
require separate registration if any location is involved with the
distribution, importation, or exportation of NPP. Further, a separate
registration is required for each principal place of business at one
general physical location where List I chemicals are distributed,
imported, or exported by a person (21 CFR 1309.23). Any person
distributing, importing, or exporting an NPP chemical mixture will be
subject to the registration requirement under the CSA as well.
Effective April 23, 2007, any person manufacturing, distributing,
importing, or exporting NPP or a chemical mixture containing NPP will
become subject to the registration requirement under the
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CSA. DEA recognizes, however, that it is not possible for persons who
are newly subject to the registration requirement to complete and
submit an application for registration and for DEA to issue
registrations for those activities immediately. Therefore, to allow
continued legitimate commerce, DEA is establishing in Sec. 1310.09(h)
a temporary exemption from the registration requirement for persons
desiring to engage in the manufacture, distribution, importation, or
exportation of NPP, provided that DEA receives a properly completed
application for registration on or before June 22, 2007. The temporary
exemption for such persons will remain in effect until DEA takes final
action on their application for registration or on their application
for exemption for a chemical mixture containing NPP pursuant to Sec.
1310.13.
The temporary exemption applies solely to the registration
requirement; all other chemical control requirements, including
recordkeeping and reporting, are effective on April 23, 2007.
Additionally, the temporary exemption does not suspend applicable
Federal criminal laws relating to this chemical, nor does it supersede
state or local laws or regulations. All manufacturers, distributors,
importers, and exporters of NPP or chemical mixtures containing NPP
must comply with applicable state and local requirements in addition to
the CSA regulatory controls.
2. Records and Reports. The CSA (21 U.S.C. 830) requires that
certain records be kept and reports be made with respect to listed
chemicals. Regulations describing recordkeeping and reporting
requirements are set forth in 21 CFR Part 1310. Pursuant to 21 CFR
1310.04, a record must be made and maintained 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 will be acceptable, provided the
information is readily retrievable from the report.
Title 21 CFR 1310.05(a) requires that each regulated person shall
report to DEA any regulated transaction involving an extraordinary
quantity of a listed chemical, an uncommon method of payment or
delivery, or any other circumstance that the regulated person believes
may indicate that the listed chemical will be used in violation of the
CSA and its corresponding regulations.
3. Import/Export. All imports/exports of a listed chemical shall
comply with the CSA import and export provisions including 21 U.S.C.
957 and 971. Regulations for importation and exportation of List I
chemicals are described in 21 CFR Part 1313.
4. Security. All applicants and registrants shall provide effective
controls against theft and diversion of chemicals as described in 21
CFR 1309.71.
5. Administrative Inspection. Places, including factories,
warehouses, or other establishments and conveyances, where registrants
or other regulated persons may lawfully hold, manufacture, distribute,
dispense, administer, or otherwise dispose of a regulated chemical/
chemical mixture or where records relating to those activities are
maintained, are controlled premises as defined in 21 CFR 1316.02(c).
The CSA (21 U.S.C. 880) allows for administrative inspections of these
controlled premises as provided in 21 CFR 1316 Subpart A.
Justification for Interim Rulemaking
Under 5 U.S.C. 553(b)(B), an agency may forgo a Notice of Proposed
Rulemaking and the accompanying period of public comment where ``the
agency for good cause finds (and incorporates the finding and a brief
statement of the reasons therefore in the rules issued) that notice and
public procedure thereon are impracticable, unnecessary, or contrary to
the public interest.'' DEA is implementing these controls as an Interim
Rule because DEA has determined that the delay necessitated by
following public notice and comment procedures would be ``contrary to
the public interest.''
The public harm caused by the current illicit manufacture and
distribution of fentanyl is unprecedented. The higher potency of
fentanyl relative to heroin prevents illicit drug dealers from
adjusting (``cutting'') pure fentanyl into fixed, predictable, non-
lethal dosage concentrations resulting in overdoses and deaths among
the heroin user population. The manufacture and distribution of illicit
fentanyl has generated a pattern of outbreaks of overdoses and deaths
across the United States. Since April 2005, the current outbreak of
illicit fentanyl is responsible for at least 972 confirmed fentanyl-
related deaths and an additional 162 suspected fentanyl-related deaths.
Most of the fentanyl-related deaths have occurred since February 2006
and have occurred mostly in the Chicago, Detroit, and Philadelphia
metropolitan areas. These fentanyl-related deaths are continuing at a
sustained rate.
The current volume of deaths is creating a growing crisis for law
enforcement and health authorities. In response to the emerging crisis,
DEA joined Chicago area law enforcement agencies to convene an
emergency two-day conference on fentanyl in Chicago in June 2006 and
the Office of National Drug Control Policy (ONDCP) convened a one-day
demand reduction forum in Philadelphia in July 2006. Numerous law
enforcement and health authorities expressed concern regarding recent
increases in clandestine production of fentanyl and the resulting
overdoses and deaths. The testing of drug exhibits by Federal, State,
and local forensic laboratories confirms that the bulk of the fentanyl
being distributed in the outbreak areas has been manufactured
illicitly. Furthermore, the lack of a sudden increase in the diversion
of fentanyl-containing pharmaceutical products supports the conclusion
that the current outbreak of fentanyl-related deaths is from illicitly
manufactured fentanyl.
The increase in street-level fentanyl may be the result of the
relative ease with which fentanyl can be produced via the Siegfried
method and the widespread distribution of the Siegfried method on the
Internet. Preliminary data indicates that the majority of the deaths in
the current fentanyl outbreak have been caused by the distribution of
illicit fentanyl that was made by the Siegfried method. This
determination is based on the identification of ANPP and the absence of
the benzylfentanyl impurity in seized fentanyl drug exhibits. The
starting material for the Siegfried method, NPP, is currently
unregulated and readily available from both domestic and international
chemical supply companies.
Immediate action at the Federal level is warranted to prevent the
unregulated manufacture, importation, exportation, and distribution of
the NPP precursor chemical. DEA, as well as other law enforcement and
public health authorities, have concluded that this action is necessary
to prevent any further domestic illicit production of fentanyl. Law
enforcement has postulated that many of the fentanyl-related overdoses
and deaths in the Chicago and Detroit areas may be associated with a
clandestine fentanyl laboratory recently seized in Mexico. However, a
significant number of the fentanyl-related overdoses and deaths may
also be associated with domestic clandestine fentanyl laboratories.
Control of NPP will aid DEA's efforts to combat domestic production of
illicit
[[Page 20044]]
fentanyl by enabling DEA to track NPP from its importation through all
domestic transactions. Furthermore, the regulatory controls on the
exportation of NPP to potential source countries will help DEA prevent
the use of NPP exported from the United States for the foreign
production of illicit fentanyl.
In April 2006, DEA issued an officer safety alert regarding the
special precautions that must be observed when handling and processing
suspected fentanyl. DEA is concerned with the unusual health hazards
posed to law enforcement officers and forensic chemists from exposure
to high purity fentanyl during law enforcement operations. Since high
purity fentanyl can be fatal if sub-milligram quantities are
accidentally swallowed, inhaled, or absorbed through the skin, the
potential for lethal fentanyl exposure to law enforcement officers
exists during raids of fentanyl clandestine laboratories, during
seizures of drug exhibits, and during subsequent testing of pure
fentanyl in the forensic laboratories. The primary lethal exposure
routes from high purity fentanyl are the following: Accidental
inhalation of airborne fentanyl powder; accidental transfer of fentanyl
powder/liquid from contaminated hands/gloves that inadvertently touch
the mouth, nose, or other mucous membranes; and accidental transfer
through cuts in the skin or roughly abraded skin.
Another reason DEA is issuing the regulation of NPP as an Interim
Rule is to prevent illicit fentanyl manufacturers from stockpiling NPP.
A Notice of Proposed Rulemaking would provide advance warning to
illicit fentanyl manufacturers of DEA's intent to control NPP. The
illicit fentanyl manufacturers could easily stockpile multiple
kilograms of NPP undetected before the chemical becomes regulated. Due
to the potency of fentanyl, the stockpiling of as little as 10
kilograms of NPP is sufficient to cause another outbreak of fentanyl-
related deaths of the unprecedented magnitude the U.S. is currently
experiencing.
The Administrative Procedure Act permits an agency to forgo the
delay in effective date associated with substantive rules ``for good
cause found and published with the rule'' (5 U.S.C. 553(d)(3)). For the
same reasons discussed above, in order to protect the public health and
prevent further illicit production of fentanyl, this rule shall be
effective immediately upon publication. Furthermore, pursuant to its
authority under 21 U.S.C. 821 and 871, DEA has concluded that the
threat to public health and safety is such that it is necessary and
appropriate for DEA to forgo the requirements of 21 CFR 1310.02(c) that
the agency publish a proposal 30 days prior to adding a listed chemical
by final rule.
Handling of Confidential or Proprietary Information
Confidential or proprietary information may be submitted as part of
a comment regarding this Interim Rulemaking. Confidential or
proprietary information should be clearly identified at the beginning
of the comment. Information designated as confidential or proprietary
will be treated accordingly. The release of confidential business
information is protected from disclosure by Exemption 4 of the Freedom
of Information Act (FOIA), 5 U.S.C. 552(b)(4), and the U.S. Department
of Justice procedures set forth in 28 CFR 16.8. Comments may be
submitted using the information provided in the ADDRESSES section of
this document, and must be postmarked on or before June 22, 2007.
Regulatory Certifications
Regulatory Flexibility Act and Small Business Concerns
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 605(b)). The Regulatory Flexibility Act (RFA) applies to rules
that are subject to notice and comment. DEA is issuing this rule as an
emergency action and an interim final rule. Therefore, the RFA
provisions do not apply. DEA did consider, however, the impact on small
entities.
Some of the firms DEA identified as potentially handling NPP are
small entities. The highest cost that the rule would impose on these
firms is less than $2,500 for registration. The smallest firm (1 to 4
employees) in the organic chemical sector has annual revenues of about
$1.1 million. For those not already registered with DEA, the cost of
registration represents 0.2 percent of annual revenues, which does not
constitute a significant economic impact. Consequently, this rule will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12866
The Deputy Administrator certifies that this rulemaking has been
drafted in accordance with the principles in Executive Order 12866
Sec. 1(b). It has been determined that this is ``a significant
regulatory action.'' Therefore, this action has been reviewed by the
Office of Management and Budget.
DEA is listing NPP as a List I chemical. Anyone manufacturing,
distributing, importing, or exporting NPP will have to register each
location where NPP is handled, maintain records of transactions
involving NPP, and take steps to ensure that the chemicals are secure
(e.g., stored in sealed containers in areas where access can be
controlled or monitored). The requirement for records of transactions
can be met using routine business records (e.g., purchase orders,
shipping papers).
DEA has identified 14 domestic chemical companies that supply NPP
and that would be required to comply with this rule. Furthermore, DEA
has determined that the vast majority of the domestic use of NPP is for
the manufacture of the schedule II drug fentanyl. Eight companies may
domestically manufacture NPP, of which two of these companies may also
import NPP. However, DEA has not been able to determine whether these
companies are currently manufacturing NPP. Some companies may not
manufacture NPP, but rather purchase NPP in order to redistribute it to
meet special orders. Other companies may manufacture NPP upon receiving
an order; one company indicated that it has not produced NPP for two
years. DEA has identified an additional six domestic companies that
appear to only import NPP for subsequent domestic distribution. DEA has
been able to document one domestic pharmaceutical company that uses NPP
to manufacture fentanyl or fentanyl analogues.
The cost of compliance with the chemical requirements is basically
the cost of the annual registration fee ($2,430 for manufacturers;
$1,215 for distributors, importers, and exporters) plus the time
required to complete the registration form (0.5 hours); registrations
can be completed online. The recordkeeping requirements can be met with
normal business records. The FDA requirements for manufacturing
practices for pharmaceutical ingredients, together with the value of
the products, generally ensure that firms already have security
measures adequate to meet DEA's requirements. Even if the two firms
that could manufacture or import obtained separate registrations for
the two business activities, the total cost of the rule would be less
than $30,000, which is the rounded estimate of the cost for all
fourteen firms to register with DEA in their respective business
activities.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and
[[Page 20045]]
3(b)(2) of Executive Order 12988, Civil Justice Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of State
law; nor does it impose enforcement responsibilities on any State; nor
does it diminish the power of any State to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Paperwork Reduction Act
This Interim Rulemaking will subject persons handling NPP to CSA
List I regulatory requirements. Any person who manufactures,
distributes, imports, or exports NPP must register with DEA. As
discussed previously, DEA has identified 14 domestic chemical companies
who would be required to register with DEA. Persons wishing to register
with DEA to handle List I chemicals must do so using DEA Form 510,
Application for Registration under Domestic Chemical Diversion Control
Act of 1993, and persons wishing to renew their registration must do so
using DEA Form 510a, Renewal Application for Registration under
Domestic Chemical Diversion Control Act of 1993 [OMB control
1117-0031].
Persons importing, exporting, and conducting international
transactions involving NPP must comply with regulatory requirements
regarding the notification of DEA of pending transactions. As DEA
cannot estimate how many of the 14 identified firms import, export, or
conduct international transactions with NPP, DEA is estimating that all
identified firms conduct such transactions. DEA has no information
regarding actual number of transactions conducted annually, but based
on the uses of NPP believes that the number of transactions is very
low. DEA is estimating that each firm will conduct five import
transactions, and two export transactions annually. DEA has not
identified any firms serving as United States brokers conducting
international transactions involving NPP. Therefore, DEA has not
estimated any international transactions involving NPP.
The U.S. Department of Justice, Drug Enforcement Administration,
has submitted the following information collection requests to the
Office of Management and Budget (OMB) for review and clearance in
accordance with review procedures of the Paperwork Reduction Act of
1995. The information collections are published to obtain comments from
the public and affected agencies.
All comments and suggestions, or questions regarding additional
information, to include obtaining a copy of the proposed information
collection instrument with instructions, should be directed to Mark W.
Caverly, Chief, Liaison and Policy Section, Office of Diversion
Control, Drug Enforcement Administration, Washington, DC 20537.
Written comments and suggestions from the public and affected
agencies concerning the collections of information are encouraged. Your
comments on the information collection-related aspects of this rule
should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
Overview of Information Collections 1117-0031:
(1) Type of Information Collection: Revision of an existing
collection.
(2) Title of the Form/Collection: Application for Registration
under Domestic Chemical Diversion Control Act of 1993 and Renewal
Application for Registration under Domestic Chemical Diversion Control
Act of 1993.
(3) Agency form number, if any, and the applicable component of the
U.S. Department of Justice sponsoring the collection:
Form Number: DEA Form 510 and DEA Form 510a.
Office of Diversion Control, Drug Enforcement Administration, U.S.
Department of Justice.
(4) Affected public who will be asked or required to respond, as
well as a brief abstract:
Primary: Business or other for-profit.
Other: Not-for-profit, government agencies.
Abstract: The Domestic Chemical Diversion Control Act requires that
manufacturers, distributors, importers, and exporters of List I
chemicals which may be diverted in the United States for the production
of illicit drugs must register with DEA. Registration provides a system
to aid in the tracking of the distribution of List I chemicals.
(5) An estimate of the total number of respondents and the amount
of time estimated for an average respondent to respond: DEA estimates
that 2,301 persons respond to this collection annually. DEA estimates
that it takes 30 minutes for an average respondent to respond when
completing the application on paper, and 15 minutes for an average
respondent to respond when completing an application electronically.
This application is submitted annually.
(6) An estimate of the total public burden (in hours) associated
with the collection: DEA estimates that this collection has a public
burden of 783 hours annually.
------------------------------------------------------------------------
Total
Form Number burden
respondents hours
------------------------------------------------------------------------
DEA-510 (paper)............................... 187 93.5
DEA-510 (electronic).......................... 102 25.5
DEA-510a (paper).............................. 644 322
DEA-510a (electronic)......................... 1,368 342
-------------------------
Total..................................... ........... 783
------------------------------------------------------------------------
[[Page 20046]]
Overview of Information Collection 1117-0023:
(1) Type of Information Collection: Revision of an existing
collection.
(2) Title of the Form/Collection: Import/Export Declaration for
List I and List II Chemicals.
(3) Agency form number, if any, and the applicable component of the
U.S. Department of Justice sponsoring the collection:
Form Number: DEA Form 486.
Office of Diversion Control, Drug Enforcement Administration, U.S.
Department of Justice.
(4) Affected public who will be asked or required to respond, as
well as a brief abstract:
Primary: Business or other for-profit.
Other: None.
Abstract: Persons importing, exporting, and conducting
international transactions with List I and List II chemicals must
notify DEA of those transactions in advance of their occurrence,
including information regarding the person(s) to whom the chemical will
be transferred and the quantity to be transferred. For importations,
persons must also provide return declarations, confirming the date of
the importation and transfer, and the amounts of the chemical
transferred. This information is used to prevent shipments not intended
for legitimate purposes.
(5) An estimate of the total number of respondents and the amount
of time estimated for an average respondent to respond:
----------------------------------------------------------------------------------------------------------------
Number of Number of
respondents responses Average time per response Total hours
----------------------------------------------------------------------------------------------------------------
Form 486 (export)...................... 239 7,945 0.2 hour (12 minutes)... 1,589
Form 486 (export return declaration)... 239 7,945 0.08 hour (5 minutes)... 662.08
Form 486 (import)...................... 230 2,348 0.25 hour (15 minutes).. 587
Form 486 (import return declaration)*.. 230 2,583 0.08 hour (5 minutes)... 215.2
Form 486 (international transaction)... 9 111 0.2 hour (12 minutes)... 22.2
Form 486 (international transaction 9 111 0.08 hour (5 minutes)... 9.25
return declaration).
Quarterly reports for imports of 110 440 0.5 hour (30 minutes)... 220
acetone, 2-butanone, and toluene.
------------------------------------------------------------------------
Total.............................. 239 .............. ......................... 3,304.73
----------------------------------------------------------------------------------------------------------------
* DEA assumes 10% of all imports will not be transferred in the first thirty days and will necessitate
submission of a subsequent return declaration.
(6) An estimate of the total public burden (in hours) associated
with the collection: DEA estimates that this collection will take 3,305
hours annually.
If additional information is required, contact: Lynn Bryant,
Department Clearance Officer, Information Management and Security
Staff, Justice Management Division, U.S. Department of Justice, Patrick
Henry Building, Suite 1600, 601 D Street NW., Washington, DC 20530.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$114,000,000 or more in any one year, and will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995.
Congressional Review Act
This rule is not a major rule as defined by Section 804 of the
Congressional Review Act/Small Business Regulatory Enforcement Fairness
Act of 1996 (Congressional Review Act). This rule will not result in an
annual effect on the economy of $100,000,000 or more; a major increase
in cost or prices; or significant adverse effects on competition,
employment, investment, productivity, innovation, or on the ability of
United States-based companies to compete with foreign-based companies
in domestic and export markets.
List of Subjects 21 CFR Part 1310
Drug traffic control, List I and List II chemicals, reporting
requirements.
0
For the reasons set out above, 21 CFR Part 1310 is amended as follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES
0
1. The authority citation for part 1310 continues to read as follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
0
2. Section 1310.02 is amended by adding a new paragraph (a)(28) to read
as follows:
Sec. 1310.02 Substances covered.
* * * * *
(a) * * *
(28) N-phenethyl-4-piperidone (NPP)--8332.
* * * * *
0
3. Section 1310.04 is amended by adding a new paragraph (g)(1)(vi) to
read as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(g) * * *
(1) * * *
(vi) N-phenethyl-4-piperidone (NPP)
* * * * *
0
4. Section 1310.09 is amended by adding new paragraph (h) to read as
follows:
Sec. 1310.09 Temporary exemption from registration.
* * * * *
(h) 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-phenethyl-4-piperidone (NPP), including regulated chemical
mixtures pursuant to Sec. 1310.12, is temporarily exempted from the
registration requirement, provided that DEA receives a proper
application for registration or application for exemption for a
chemical mixture containing NPP pursuant to Sec. 1310.13 on or before
June 22, 2007. 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. Any person who manufactures, distributes, imports or exports a
chemical mixture containing N-phenethyl-4-piperidone (NPP) whose
application for exemption is subsequently denied by DEA must obtain a
registration with DEA. A
[[Page 20047]]
temporary exemption from the registration requirement will also be
provided for those persons whose application for exemption are denied,
provided that DEA receives a properly completed application for
registration on or before 30 days following the date of official DEA
notification that the application for exemption has been denied. The
temporary exemption for such persons will remain in effect until DEA
takes final action on their registration application.
0
5. Section 1310.12 is amended by adding in alphabetical order in the
table in paragraph (c) an entry for ``N-phenethyl-4-piperidone (NPP)''
to read as follows:
Sec. 1310.12 Exempt chemical mixtures.
* * * * *
(c) * * *
Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
DEA chemical code No. Concentration Special conditions
----------------------------------------------------------------------------------------------------------------
* * * * * * *
N-phenethyl-4-piperidone (NPP)..... 8332....................... Not exempt at any Chemical mixtures
concentration. containing any amount
of NPP are not
exempt.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: April 11, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 07-2015 Filed 4-20-07; 8:45 am]
BILLING CODE 4410-09-C