[Federal Register Volume 73, Number 144 (Friday, July 25, 2008)]
[Rules and Regulations]
[Pages 43355-43357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17034]


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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.

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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

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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

0
The Interim Rule amending part 1310 of Title 21, of the Code of Federal 
Regulations, which published in the Federal Register on April 23, 2007 
at 72 FR 20039, is hereby adopted as a Final Rule without change.

    Dated: July 17, 2008.
Michele M. Leonhart,
Acting Administrator.
 [FR Doc. E8-17034 Filed 7-24-08; 8:45 am]
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