Federal
Register Notices > Rules
- 2006 > Proposed
Rule - Authorized Sources of Narcotic Raw Materials
FR Doc E6-16325 [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]
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).
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.
1 "Narcotic Drugs: Estimated World Requirements for 2005-- Statistics for
2003", Tables II and XIII; International Narcotics Control Board (E/INCB/2004/2).
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:
- Turkey,
- India,
- Spain,
- France,
- Poland,
- Hungary, and
- 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
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