Authorized Sources of Narcotic Raw Materials, 58569-58571 [E6-16325]

Download as PDF Federal Register / Vol. 71, No. 192 / Wednesday, October 4, 2006 / Proposed Rules can then use these estimates for the specified periods at the beginning and end of the eligible period to add to the financial amounts for 2002, 2003, and 2004 to calculate the total amounts sought in Appendix A. rmajette on PROD1PC67 with PROPOSALS1 12. Has the applicant or any of its subsidiaries or affiliates received grants, subsidies, incentives or similar payments from local, state, or Federal governmental entities in support of the security, maintenance and provision of general aviation services and facilities furnished in response to the events of September 11, 2001? (This includes payments under the Aviation and Transportation Security Act of 2001 (Public Law 107–38) and the Airport Improvement Program under the Airport and Airway Improvement Act of 1982 (Public Law 97–248).) This question requires that you disclose all grants, subsidies, or incentives that you received during the eligible reimbursement period, either directly or indirectly, from Federal, State, and local entities, to reimburse you for the cost of operations and capital improvements associated with implementing security programs, or maintaining or providing general aviation services and facilities. 13. Has the applicant or any of its subsidiaries or affiliates incurred lobbying expenses, mitigating expenses, or special expenses (as described in the section captioned ‘‘What information must operators or providers submit in their applications for reimbursement?’’), or extraordinary adjustments. Check ‘‘Yes’’ if you incurred any such expenses or experienced any such adjustments. You must briefly describe the nature of such expenses and adjustments, including the amounts. Additionally, you must indicate whether or not such expenses or adjustments have been included in or excluded from the totals in the table at item number 11. Lobbying includes any amount paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress. Mitigating expenses include the utilization of property, the provision of services and the sale of goods that were undertaken to mitigate losses arising from the Federal Government’s closure of airports attendant to the September 11, 2001 attack. These could include expenses incurred for the provision of services and sale of goods moved from restricted airports to unrestricted airports or compensation for non-aviation oriented goods and services provided at restricted airports. Mitigating expenses may also include expenses for aviation-related fixed assets or capital utilized outside of the restricted airport. Special expenses include, but are not limited to, moving expenses, additional security equipment and facilities, and loss on sale of assets that arose from the direct imposition of restrictions during the period September 11, 2001 through the applicable eligible date. Any item reported as Special Expenses shall not also be expensed in other VerDate Aug<31>2005 15:20 Oct 03, 2006 Jkt 211001 expense categories that are reflected in the calculation of the reimbursement claim. Details regarding special expenses should be noted in footnotes. Extraordinary adjustments are events or transactions that are material to your business and unusual in nature and infrequent in occurrence. 14. Certification You must certify that all information contained on the Background and Eligibility Form and the documents submitted in support of your application (e.g. profit and loss statements, actual forecasts, after-the-fact forecasts, etc.) are accurate. This certification is made under penalty of law. Falsification may be grounds for monetary and/or criminal sanctions. This certification must be made by a company CEO, COO, or CFO. [FR Doc. 06–8250 Filed 10–3–06; 8:45 am] BILLING CODE 4910–9X–C 58569 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 https:// www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the https://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. 21 CFR Part 1312 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. [Docket No. DEA–282P] SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE Drug Enforcement Administration RIN 1117–AB03 Legal Authority Authorized Sources of Narcotic Raw Materials Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice of proposed rule making (NPRM). AGENCY: SUMMARY: DEA proposes to amend its regulations to update the list of nontraditional 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 PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 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 E:\FR\FM\04OCP1.SGM 04OCP1 58570 Federal Register / Vol. 71, No. 192 / Wednesday, October 4, 2006 / Proposed Rules rmajette on PROD1PC67 with PROPOSALS1 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 nontraditional 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 VerDate Aug<31>2005 14:41 Oct 03, 2006 Jkt 211001 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 costeffective 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. DEA has reviewed the petition and is proposing to change the list of nontraditional suppliers to remove Yugoslavia and replace it with Spain. DEA has determined that the successor states to the former Yugoslavia no 1 ‘‘Narcotic Drugs: Estimated World Requirements for 2005—Statistics for 2003’’, Tables II and XIII; International Narcotics Control Board (E/INCB/ 2004/2). PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 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. E:\FR\FM\04OCP1.SGM 04OCP1 Federal Register / Vol. 71, No. 192 / Wednesday, October 4, 2006 / Proposed Rules 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 foreignbased 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: § 1312.13 Issuance of import permit. rmajette on PROD1PC67 with PROPOSALS1 * * * * * (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. VerDate Aug<31>2005 14:41 Oct 03, 2006 Jkt 211001 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 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 281 [EPA–RO1–UST–2006–0622; FRL–8226–6] New Hampshire: Final Approval of Underground Storage Tank Program Revisions Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: SUMMARY: The State of New Hampshire has applied to EPA for approval of the changes to its underground storage tank program under Subtitle I of the Resource Conservation and Recovery Act (RCRA). EPA has determined that these amendments satisfy all requirements needed for program approval and proposes to approve the State’s changes. In the ‘‘Rules and Regulations’’ section of this Federal Register, EPA is approving the changes by an immediate final rule. EPA did not make a proposal prior to the immediate final rule because we believe this action is not controversial and do not expect comments that oppose it. We have explained the reasons for this approval in the preamble to the immediate final rule. Unless we get written comments which oppose this approval during the comment period, the immediate final rule will become effective on the date it establishes, and we will not take further action on this proposal. If we receive comments that oppose this action, we will withdraw the immediate final rule and it will not take effect. We will then respond to public comments in a later final rule based on this proposal. You may not have another opportunity for comment. If you want to comment on this action, you must do so at this time. DATES: Send your written comments by November 3, 2006. ADDRESSES: Submit your comments, identified by Docket ID No. EPA–R01– UST–2006–0622, by one of the following methods: • www.regulations.gov: Follow the on-line instructions for submitting comments. • E-mail: hanamoto.susan@epa.gov. • Mail: Susan Hanamoto, Office of Underground Storage Tanks, EPA Region I, One Congress Street, Suite PO 00000 Frm 00027 Fmt 4702 Sfmt 4702 58571 1100 (Mail Code: HBO), Boston, MA 02114–2023. • Hand Delivery: Susan Hanamoto, Office of Underground Storage Tanks, EPA Region I, One Congress Street, Suite 1100 (Mail Code: HBO), Boston, MA 02114–2023. Such deliveries are only accepted during the EPA’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Docket ID No. EPA–R01–UST–2006– 0622. EPA’s policy is that all comments received will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or e-mail. The www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: EPA has established a docket for this action under Docket ID No. EPA–R01–UST–2006–0622. All documents in the docket are listed on the www.regulations.gov Web site. Although listed in the index, some information may not be publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the EPA Region I Library, One Congress Street, 11th Floor, Boston, MA 02114– E:\FR\FM\04OCP1.SGM 04OCP1

Agencies

[Federal Register Volume 71, Number 192 (Wednesday, October 4, 2006)]
[Proposed Rules]
[Pages 58569-58571]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16325]


=======================================================================
-----------------------------------------------------------------------

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 https://www.regulations.gov using the electronic 
comment form provided on that site. An electronic copy of this document 
is also available at the https://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:
    (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
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