[Federal Register Volume 72, Number 77 (Monday, April 23, 2007)]
[Rules and Regulations]
[Pages 20039-20047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-2015]


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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 [email protected]. 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?>

[[Page 20042]]

    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