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4 October 2006
[Federal Register: October 4, 2006 (Volume 71, Number 192)]
[Proposed Rules]
[Page 58569-58571]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc06-24]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1312
[Docket No. DEA-282P]
RIN 1117-AB03
Authorized Sources of Narcotic Raw Materials
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice of proposed rule making (NPRM).
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SUMMARY: DEA proposes to amend its regulations to update the list of
non-traditional countries authorized to export narcotic raw materials
(NRM) to the United States. This change would replace Yugoslavia with
Spain. This proposed rule seeks to maintain a consistent and reliable
supply of narcotic raw materials from a limited number of countries
consistent with United States obligations under international treaties
and resolutions.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before December 4, 2006.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-282P'' on all written and electronic correspondence.
Written comments being sent 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/Liaison and Policy Section (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 directly
sent 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, Telephone (202) 307-
7183.
SUPPLEMENTARY INFORMATION:
Legal Authority
DEA enforces the Controlled Substances Act (CSA) (21 U.S.C. 801 et
seq.), as amended. DEA regulations implementing this statute are
published in Title 21 of the Code of Federal Regulations (CFR), parts
1300 to 1399. These regulations are designed to establish a framework
for the legal distribution of controlled substances to deter their
diversion for illegal purposes and to ensure an adequate and
uninterrupted supply of these drugs for legitimate medical purposes.
The CSA and its implementing regulations are consistent with United
States treaty obligations that, among other things, address the
production, import, and export of controlled substances.
Controlled Substances
Controlled substances are drugs that have a potential for abuse and
addiction; these include substances classified as opiates, stimulants,
depressants, hallucinogens, anabolic steroids, and drugs that are
immediate precursors of these classes of substances. DEA lists
controlled substances in 21 CFR part 1308. The substances are divided
into five schedules: Schedule I substances have a high potential for
abuse and have no accepted medical use. These substances may only be
used for research, chemical analysis, or manufacture of other drugs.
Schedule II-V substances have an accepted medical use and also have a
[[Page 58570]]
potential for abuse and addiction. Narcotic raw materials (opium, poppy
straw, and concentrate of poppy straw (CPS)) are in Schedule II and are
the materials from which morphine, codeine, and thebaine are extracted
for purposes of manufacturing a number of Schedule II controlled
substances.
Sources of Narcotic Raw Materials
In May 1979, the United Nations' Economic and Social Council
(ECOSOC) adopted Resolution 471, which called on importing countries
such as the United States to support traditional suppliers of narcotic
raw materials (NRM) and to limit imports from non-traditional supplying
countries. The resolution, which was reaffirmed by ECOSOC in 1981, was
adopted to limit overproduction of NRM, to restore a balance between
supply and demand, and to prevent diversion to illicit channels. The
United States, based on long-standing policy, does not cultivate or
produce NRM, but relies solely on opium, poppy straw, and CPS produced
in other countries for the NRM necessary to meet the legitimate medical
needs of the United States. In response to Resolution 471, on August
18, 1981, DEA published a final rule specifying certain source
countries of NRM (46 FR 41775); the rule is frequently referred to as
the 80/20 rule. Under the final rule, currently codified as 21 CFR
1312.13(f) and (g), NRM can be imported from one of only seven
countries. Traditional suppliers India and Turkey must be the source of
at least 80 percent of the United States' requirement for NRM. Five
countries--France, Poland, Hungary, Australia, and Yugoslavia--may be
the source of not more than 20 percent. The United States continues to
reaffirm its support of the original resolution by supporting similar
resolutions each year at the CND.
Recently, DEA registered importers of NRM have imported
approximately 90 percent of NRM from traditional suppliers India and
Turkey. India is the only country that cultivates poppies for
production of opium. All other exporting countries use the CPS method
of NRM production, a method that allows the plant to go to seed;
portions of the plant are then processed into a concentrate. It is
generally believed that CPS is less divertible than opium. CPS may be
rich in morphine (CPS-M) or rich in thebaine (CPS-T). The United States
imports the majority of its CPS-M from Turkey, with Australia supplying
much of the balance.
The 80/20 rule was established based on traditional import amounts
and on the U.N. resolution calling on member nations to support
traditional sources that have been reliable suppliers and that take
measures to curtail diversion. The United States allowed a limited
number of non-traditional suppliers to have access to the United States
market based on past commercial relationships and on the desirability
of preserving alternative sources. This approach was consistent with
the U.N. Resolution because it supported India and Turkey, and ensured
an adequate and uninterrupted supply of NRM, while limiting the number
of supplying countries. DEA continues to support the 80/20 rule.
On June 6, 2005, the Government of Spain petitioned DEA seeking to
be added to the list of non-traditional suppliers. Spain stated four
reasons that granting its petition would be consistent with United
States interests:
The change would be consistent with the 80/20 rule because
it maintains India and Turkey as the two traditional supplier
countries, that is, Spain does not seek to be added to the list of
traditional suppliers.
The change would ensure adequate supplies of NRM.
The change would not result in diversion because Spain
maintains strict control and oversight over the cultivation and
distribution of NRM.
The change would allow DEA to monitor diversion and
maintain cost-effective supplies.
In its petition, Spain explained that in the early 1970s, Spanish
pharmaceutical firms sought authorization to cultivate opium poppies to
produce NRM. In 1973, Spain authorized a single firm, Alcaliber, to
cultivate, harvest, store, and prepare extracts from the opium poppy.
Spain is now the fifth largest cultivator of opium poppies; Spain is
the fourth largest producer of CPS and the third largest exporter of
CPS-M.\1\ Spain has ratified international agreements to control
production and commerce in opium products. In accordance with these
international agreements, Spain has implemented a comprehensive
regulatory regime for controlling the cultivation, production, and
export of NRM. The petition stated that this control ensures that NRM
produced in Spain are not diverted to illicit uses.
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\1\ ``Narcotic Drugs: Estimated World Requirements for 2005--
Statistics for 2003'', Tables II and XIII; International Narcotics
Control Board (E/INCB/2004/2).
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DEA has reviewed the petition and is proposing to change the list
of non-traditional suppliers to remove Yugoslavia and replace it with
Spain. DEA has determined that the successor states to the former
Yugoslavia no longer produce NRM for export. Therefore, replacing
Yugoslavia with Spain will continue to limit the number of non-
traditional suppliers to the United States while ensuring that an
adequate number of sources of NRM are available. The change does not
otherwise affect how the 80/20 rule is implemented.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Assistant Administrator, Office of Diversion Control,
hereby certifies that this rulemaking has been drafted in accordance
with the Regulatory Flexibility Act (5 U.S.C. 605(b)), that he has
reviewed this regulation, and by approving it certifies that this
regulation will not have a significant economic impact on a substantial
number of small business entities. The proposed rule imposes no new
costs or burden on small entities.
Executive Order 12866
The Deputy Assistant Administrator, Office of Diversion Control,
further 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 a significant regulatory action. Therefore,
this action has been reviewed by the Office of Management and Budget.
Executive Order 12988
This proposed rule meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988.
Executive Order 13132
This proposed rule 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.
Unfunded Mandates Reform Act of 1995
This proposed rule will not result in the expenditure by State,
local, and tribal governments, in the aggregate, or by the private
sector, of $117,000,000 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.
[[Page 58571]]
Small Business Regulatory Enforcement Fairness Act of 1996
This proposed rule is not a major rule as defined by Section 804 of
the Small Business Regulatory Enforcement Fairness Act of 1996. This
rule will not result in an annual effect on the economy of $100,000,000
or more; a major increase in costs 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 1312
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1312 is proposed to be
amended as follows:
PART 1312--IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES
1. The authority citation for Part 1312 continues to read as
follows:
Authority: 21 U.S.C. 952, 953, 954, 957, 958.
2. Section 1312.13 is proposed to be amended by revising paragraphs
(f) and (g) to read as follows:
Sec. 1312.13 Issuance of import permit.
* * * * *
(f) Notwithstanding paragraphs (a)(1) and (a)(2) of this section,
the Administrator shall permit, pursuant to 21 U.S.C. 952(a)(1) or
(a)(2)(A), the importation of approved narcotic raw material (opium,
poppy straw and concentrate of poppy straw) having as its source:
(1) Turkey,
(2) India,
(3) Spain,
(4) France,
(5) Poland,
(6) Hungary, and
(7) Australia.
(g) At least eighty (80) percent of the narcotic raw material
imported into the United States shall have as its original source
Turkey and India. Except under conditions of insufficient supplies of
narcotic raw materials, not more than twenty (20) percent of the
narcotic raw material imported into the United States annually shall
have as its source Spain, France, Poland, Hungary and Australia.
Dated: September 26, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E6-16325 Filed 10-3-06; 8:45 am]
BILLING CODE 4410-09-P