Federal
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Control of a Chemical Precursor Used in the Illicit
Manufacture of Fentanyl as a List I Chemical
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FR Doc E8-17034[Federal Register: July 25, 2008 (Volume 73,
Number 144)] [Rules and Regulations] [Page 43355-43357] From the
Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy08-10]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-299F] 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),
Department of Justice.
ACTION: Final rule.
SUMMARY: The Drug Enforcement Administration (DEA) is
finalizing the
[[Page 43356]]
Interim Rule with Request for Comment published in the
Federal Register on April 23, 2007. The Interim Rule controlled
the chemical N- phenethyl-4-piperidone (NPP) as a List I
chemical under the Controlled Substances Act. Clandestine
laboratories are using this chemical to illicitly manufacture
the schedule II controlled substance fentanyl. No comments to
the Interim Rule were received. This Final Rule finalizes the
regulations without change.
DATES: Effective Date: July 25, 2008.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud,
PhD., Chief, Drug and Chemical Evaluation Section, Office of
Diversion Control, Drug Enforcement Administration, 8701
Morrissette Drive, Springfield, Virginia 22152 at (202)
307-7183.
SUPPLEMENTARY INFORMATION:
Background
On April 23, 2007 (72 FR 20039), the Drug Enforcement
Administration (DEA) published an Interim Rule with Request for
Comment which established regulations controlling the chemical
N-phenethyl-4- piperidone (NPP) as a List I chemical under the
Controlled Substances Act (CSA). This action was taken because
DEA was extremely concerned with the increase in the illicit
manufacture and distribution of fentanyl, which resulted in more
than 1,000 confirmed or suspected 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, drug abusers have difficulty
determining how much to take to get their "high'' and sometimes
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 and chemists exists during
raids of fentanyl clandestine laboratories, during seizures of
drug exhibits, and during subsequent testing of pure fentanyl in
the forensic laboratories.
Illicit Manufacture of Fentanyl
As discussed extensively in the Interim Rule with Request for
Comment, DEA determined from the forensic testing of seized
illicit fentanyl that the chemical NPP was being used to
illicitly manufacture fentanyl. Since 2000, four of the five
domestic fentanyl clandestine laboratories seized by law
enforcement have used NPP as starting material 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, 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. The Interim Rule
made 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 regulated the chemical NPP as a List I
chemical under the CSA (21
U.S.C. 801 et seq.). Furthermore, under 21
U.S.C Sec. 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
The distribution of illicit fentanyl or illicit fentanyl
combined with heroin or cocaine has resulted in an outbreak of
more than 1,000 confirmed or suspected fentanyl-related
overdoses and fentanyl-related deaths across the country
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. As discussed in the Interim
Rule with Request for Comment, from the information and data
collected, there is strong indication that the fentanyl in these
confirmed and suspected fentanyl-related deaths is illicitly
manufactured rather than diverted from legal pharmaceutical
manufacturers. The current forensic data suggests that most of
these fentanyl-related deaths are from fentanyl illicitly
manufactured using NPP.
Availability of the Precursor Chemical
DEA determined that the precursor chemical, NPP, is readily
available from commercial chemical suppliers. DEA 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. Further, a
fentanyl clandestine laboratory in Mexico is believed to have
obtained the NPP precursor chemical from an international
supplier. Law enforcement identified four separate chemical
suppliers that have distributed NPP to illicit fentanyl
clandestine laboratories.
Regulation of NPP as a List I Chemical
Based on the above, on April 23, 2007, DEA published an
Interim Rule with Request for Comment (72 FR 20039) controlling
NPP as a List I chemical. That rule made the domestic sale of
NPP a regulated transaction. That rule also made 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
[[Page 43357]]
the domestic diversion of NPP for the illicit manufacture of
fentanyl in the United States. Finally, that rule specified that
chemical mixtures containing NPP were not 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 DEA
under 21
CFR 1310.13.
Comments Received
DEA did not receive any comments to its Interim Rule with
Request for Comment (72 FR 20039, April 23, 2007) controlling
NPP as a List I chemical and regulating all chemical mixtures
containing NPP. Therefore, DEA is hereby finalizing that Interim
Final Rule without change.
Regulatory Certifications
Administrative Procedure Act (5 U.S.C. 553)
An agency may find good cause to exempt a rule from certain
provisions of the Administrative Procedure Act (5 U.S.C. 553),
including making the rule effective upon the date of
publication. DEA finds good cause to make this rule effective
upon publication, as this Final Rule merely confirms existing
regulatory requirements implemented as part of the Interim Rule
with Request for Comment published April 23, 2007, at 72 FR
20039.
Regulatory Flexibility Act and Small Business Concerns
The Acting Administrator hereby certifies that this
rulemaking has been drafted in accordance with the Regulatory
Flexibility Act (5 U.S.C. 605(b)).
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. DEA did not receive any comments to
its Interim Rule controlling NPP as a List I chemical.
Therefore, the Acting Administrator certifies that this rule
will not have a significant economic impact on a substantial
number of small entities.
Executive Order 12866
The Acting Administrator certifies that this rulemaking has
been drafted in accordance with the principles in Executive
Order 12866 Section 1(b). It has been determined that this is "not
a significant regulatory action.'' Therefore, this action has
not been reviewed by the Office of Management and Budget.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 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
With publication of the Interim Final Rule controlling NPP as
a List I chemical (72 FR 20039), persons handling NPP became
subject to CSA List I regulatory requirements. Any person who
manufactures, distributes, imports, or exports NPP must register
with DEA. As discussed in the Interim Rule, DEA has identified
14 domestic chemical companies who would be required to register
with DEA if they continued to handle NPP. 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]. With publication of
the Interim Rule, DEA received approval from the Office of
Management and Budget to revise this information collection as
discussed above.
Persons importing, exporting, and conducting international
transactions involving NPP must comply with regulatory
requirements regarding the notification of DEA of pending
transactions. As DEA had no information on which to estimate how
many of the 14 identified firms import, export, or conduct
international transactions with NPP, DEA estimated that all
identified firms conduct such transactions. DEA estimated that
each firm will conduct five import transactions and two export
transactions annually. DEA did not identify any firms serving as
United States brokers conducting international transactions
involving NPP. Therefore, DEA did not estimate any international
transactions involving NPP. Persons importing, exporting, and
conducting international transactions involving List I chemicals
report those transactions to DEA on DEA Form 486, Import/Export
Declaration for List I and List II chemicals [OMB control
1117-0023]. With publication of the Interim Rule, DEA received
approval from the Office of Management and Budget to revise this
information collection as discussed above.
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 $120,000,000 or more (adjusted for inflation) 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 in 21 CFR Part 1310
Drug traffic control, Exports, Imports, List I and List II
chemicals, Reporting and recordkeeping requirements.
Adoption as Final Rule
Dated: July 17, 2008.
Michele M. Leonhart,
Acting Administrator.
[FR Doc. E8-17034 Filed 7-24-08; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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