Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Rules and Regulations 6843 

sentence add the word ‘‘test’’ before the 

word ‘‘frame’’. 

■ d. Redesignate paragraphs (a)(6)(v) 

through (a)(6)(ix) as paragraphs (a)(6)(vi) 

through (a)(6)(x) respectively; 

redesignate the fourth through the last 

sentence of paragraph (a)6)(iv) as 

paragraph (a)(6)(v); and add the heading 

‘‘Burner inlet lines.’’ to newly 

designated paragraph (a)(6)(v). 

■ e. In redesignated paragraph (a)(6)(vi) 

before the word ‘‘Frame’’ in the heading 

of the paragraph add the word 

‘‘Burner’’. 

■ f. In redesignated paragraph (a)(6)(vii) 

in footnote 1 remove the phrase ‘‘3 inch 

ID by inch OD’’ and add in its place the 

phrase ‘‘0.25 inch ID by 0.4 inch OD’’. 

■ g. In redesignated paragraph (a)(6)(ix), 

second sentence, remove the number 

‘‘70’’ and in its place add ‘‘140 ± 5’’; 

after the number ‘‘20’’ add ‘‘± 1’’; after 

the word ‘‘Figure’’ remove the number 

‘‘8’’ and add the number ‘‘7’’ in its 

place. 

■ h. In paragraph (b)(1)(ii), the last 

sentence, remove ‘‘20 ± .5’’ and in its 

place add ‘‘20 ± 1’’. 

■ i. In paragraph (d)(1), first sentence, 

before ‘‘0.5 m/s’’ add the words ‘‘no 

more than’’. 

■ j. In paragraph (d)(2), third sentence, 

remove the word ‘‘bed’’ and add in its 

place the word ‘‘test’’; remove the fourth 

sentence and add in its place ‘‘Carefully 

center the foundation on top of the test 

frame to eliminate any gaps between the 

bottom periphery of the foundation and 

the inside edges of the test frame. If the 

mattress is to be tested alone, place it 

similarly. A mattress tested with its 

foundation should be centered 

longitudinally and laterally on the 

foundation.’’. 

■ k. In paragraph (e) remove the number 

‘‘(ix)’’ and add in its place the number 

‘‘(x)’’. 

■ l. In paragraph (f) move the third 

sentence so that it becomes the first 

sentence of the paragraph. 

■ m. In paragraph (h)(1)(iv) add at the 

end of the first sentence the words ‘‘or 

another dimension that meets the 

requirements for a specific sample’’; 

remove the last sentence of the 

paragraph. 

■ n. In paragraph (h)(2)(i) remove the 

last sentence and add it in its place the 

words ‘‘Use a sufficient length of duct 

tape (platen to mattress top) to assure 

that the platen stays firmly against the 

surfaces of the mattress.’’. 

■ o. In paragraph (h)(2)(iv) remove the 

first sentence and add in its place the 

sentence ‘‘Make the horizontal burner 

parallel to the top of the platen (within 

3 mm (1⁄8 inch) over the burner tube 

length); when properly parallel, it 

should not be possible to insert the 3 

mm flat stock under either burner end 

by bending the copper tube section 

appropriately.’’. 

■ p. In paragraph (h)(2)(viii), first 

sentence, remove the word ‘‘its’’ and 

add in its place the words ‘‘the vertical 

burner’’; move the reference to footnote 

9 to the end of the second to last 

sentence in the paragraph. 

■ q. In paragraph (i)(2)(i) in the second 

to last sentence remove the abbreviation 

‘‘ca.’’ and add in its place the word 

‘‘approximately’’. 

■ 3. Section 1633.12 is amended as 

follows: 

■ a. In paragraph (a)(6)(iii) before ‘‘; 

and’’ add the sentence ‘‘Such 

foundation(s) shall be clearly identified 

by a simple and distinct name and/or 

number on the mattress label’’. 

■ b. In paragraph (d) after the word 

‘‘paragraphs’’ remove the phrase 

‘‘(a)(7)(i) and (a)(7)(ii), and (a)(7)(iii)’’ 

and add in their place the phrase 

‘‘(a)(6)(i) through (iii) and (a)(7)(i) 

through (iii)’’. 

Dated: January 30, 2008. 

Todd Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. E8–2027 Filed 2–5–08; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1312 

[Docket No. DEA–282F] 

RIN 1117–AB03 

Authorized Sources of Narcotic Raw 

Materials 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Final rule. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is amending the 

list of non-traditional countries 

authorized to export narcotic raw 

materials (NRM) to the United States by 

removing Yugoslavia and adding Spain. 

This rule provides DEA registered 

importers with another potential source 

from which to purchase NRM that are 

used in the production of controlled 

substances for medical purposes in the 

United States. 

DATES: Effective Date: This rule is 

effective March 7, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD, Chief, Drug 

and Chemical Evaluation Section, Office 

of Diversion Control, Drug Enforcement 

Administration, Washington, DC 20537, 

telephone (202) 307–7183. 

SUPPLEMENTARY INFORMATION: 

Background and Legal Authority 

DEA enforces the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970, often referred to as the 

Controlled Substances Act (CSA) and 

the Controlled Substances Import and 

Export Act (21 U.S.C. 801, et seq.), as 

amended. DEA regulations 

implementing these statutes are 

published in Title 21 of the Code of 

Federal Regulations (CFR), Parts 1300 to 

1316. These regulations are designed to 

ensure that there is a sufficient supply 

of controlled substances for legitimate 

medical, scientific, research, and 

industrial purposes and to deter the 

diversion of controlled substances to 

illegal 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 

psychological and physical dependence, 

including 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 in treatment in the 

United States. These substances may 

only be used for research, chemical 

analysis, or manufacture of other drugs. 

Substances listed in schedules II—V 

have accepted medical uses but also 

have potential for abuse and 

psychological and physical dependence. 

Narcotic raw materials (opium, poppy 

straw, and concentrate of poppy straw 

(CPS)) are in schedule II and are the 

materials from which morphine, 

codeine, thebaine and oripavine are 

extracted for purposes of manufacturing 

a number of schedule II and III 

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 NRM and to limit imports 

from non-traditional supplying 

countries. The resolution, which was 

reaffirmed by ECOSOC in 1981, was 


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1Today, the United States remains a significant 

importer of narcotic raw material. Its manufacturers 

currently account for one-fourth of the world 

morphine manufacturing capacity, with roughly 

two-thirds being utilized for the production of 

codeine, which is consumed as either codeine or 

hydrocodone. 

2 ‘‘Narcotic Drugs: Estimated World Requirements 

for 2005—Statistics for 2003’’, Tables II and XIII; 

International Narcotics Control Board (E/INCB/ 

2004/2). 

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 

at 21 CFR 1312.13(f) and (g), NRM can 

be imported from 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 non-traditional supplier 

countries—France, Poland, Hungary, 

Australia, and Yugoslavia—may be the 

source of not more than 20 percent. The 

80/20 rule is calculated based on the 

amount of morphine alkaloid contained 

in the NRM. The United States 

continues to reaffirm its support of the 

original resolution by supporting similar 

resolutions each year at the Commission 

on Narcotic Drugs. 

Just as with DEA’s 1979 Federal 

Register publication first proposing the 

80/20 rule (44 FR 33695), it is important 

to recite here some of the central 

principles of Resolution 471, which 

remain crucial today: 

Noting that in recent years there has been 

considerable stepping up of morphine 

producing capacity for export, leading to a 

situation of substantial overproduction of 

opiates, 

* * * * * 

Recognizing that it is essential to bring 

about a proper balance between the global 

supply and demand, 

Taking note of the continued reliance 

placed by the world community on countries 

constituting the traditional sources of supply 

for its medical needs of opiate raw materials 

and the positive response of these countries 

in meeting the world requirements and their 

contribution in the maintenance of effective 

control systems; 

Bearing in mind that the treaties which 

establish this system are based on the 

concept that the number of producers of 

narcotic materials for export should be 

limited in order to facilitate effective control; 

* * * 

In view of these principles underlying 

Resolution 471, DEA stated in proposing 

the 80/20 rule in 1979: 

The United States is a significant importer 

of narcotic raw materials. Its manufacturers 

account for one-third of the world morphine 

manufacturing capacity, most of which is 

consumed within the United States in the 

form of codeine.1 The worldwide overproduction of narcotic raw materials and 

[Resolution 471] make it necessary for the 

United States to reevaluate past and present 

narcotic policies. 

Historically, the United States has relied 

exclusively upon imports of opium gum to 

manufacture our narcotic medical supplies 

instead of cultivating opium poppies in the 

United States. The rationale behind this 57- 

year-old policy, which foregoes [sic] U.S. 

self-sufficiency, was to set an example to the 

world community to refrain from 

overproduction and to limit the number of 

opium-producing nations to a minimum. 

[44 FR 33696, June 12, 1979] 

The foregoing principles remain 

central to United States drug control 

policy and this final rule amending the 

80/20 rule. 

Of the countries included in the 80/ 

20 rule, 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), rich in thebaine 

(CPS–T), or rich in oripavine (CPS–O). 

The United States imports the majority 

of its CPS–M from Turkey, with 

Australia supplying the vast majority of 

the balance. The vast majority of CPS–

T and all CPS–O are imported from 

Australia. 

The 80/20 rule was established based 

on traditional import amounts and on 

the United Nations resolution calling on 

member nations to support traditional 

sources that have been reliable suppliers 

and to take measures that 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 

United Nations Resolution because it 

supported India and Turkey and 

ensured an adequate and uninterrupted 

supply of NRM while limiting the 

number of supplying countries. Over the 

last ten years, pursuant to the 80/20 

rule, DEA registered importers of NRM 

have imported 90 percent of United 

States NRM requirements from 

traditional suppliers India and Turkey. 

DEA continues its support of the intent 

of the 80/20 rule. 

On June 6, 2005, the Kingdom of 

Spain (hereinafter referred to as 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, the Government of Spain 

authorized a single firm, Alcaliber, S.A., 

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.2 Spain has ratified 

international agreements to control 

production and commerce in opium 

products. As stated in its petition, Spain 

has implemented a comprehensive 

regulatory regime for controlling the 

cultivation, production, and export of 

NRM in accordance with international 

treaty requirements. The petition stated 

that this control ensures that NRM 

produced in Spain are not diverted to 

illicit uses. 

After review of the petition, DEA 

published a Notice of Proposed 

Rulemaking (NPRM) in the Federal 

Register on October 4, 2006 (71 FR 

58569) to amend the list of nontraditional countries authorized to 

export NRM to the United States. 

Specifically, the proposed rule sought to 

revise the list of non-traditional 

suppliers by removing Yugoslavia and 

replacing it with Spain. At that time, 

DEA had determined that the successor 

states to Yugoslavia no longer produced 

NRM for export beyond Yugoslavia’s 

prior border (e.g., Serbia and 

Montenegro reported exports to the 

Republic of Macedonia (hereinafter 

referred to as Macedonia) only). 

Therefore, DEA concluded that 


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replacing Yugoslavia with Spain would 

continue to limit the number of nontraditional suppliers to the United 

States while ensuring the availability of 

an adequate number of sources of NRM 

for United States manufacturers. The 

proposed change would not otherwise 

affect the implementation of the 80/20 

rule. 

Comments Received 

Following publication of the Notice of 

Proposed Rulemaking on October 4, 

2006, DEA received a request for a 60- 

day extension to the comment period. 

On December 1, 2006, DEA extended 

the comment period of the proposed 

rule to January 3, 2007 (71 FR 69504). 

During the comment period, DEA 

received 14 comments from 13 

interested parties. Five comments were 

received from the following countries: 

Australia, Spain, Macedonia, and 

Turkey. One of the comments received 

from a foreign Government was a joint 

comment with a foreign control board. 

Three comments were received from 

three DEA-registered importers of NRM; 

one comment was received from a DEAregistered opiate manufacturer; one 

comment was received from a non-DEA 

registered firm; two comments were 

received from two foreign NRM 

manufacturers; and two comments were 

received from one individual. As part of 

the above-listed comments, DEA also 

received a request to extend the 

comment period, and four requests for 

a hearing. 

After the comment period had ended, 

DEA received an additional comment 

from a foreign NRM manufacturer. This 

prompted two additional late 

comments, one from the foreign control 

board which previously commented on 

the NPRM and the other from the 

foreign government associated with that 

foreign control board. Specifically, both 

commenters sought clarification from 

DEA on the status of the late comment, 

which DEA had administratively added 

to the docket. The Administrative 

Procedure Act (APA) does not address 

the issue of late comments, and the 

United States courts generally defer to 

federal agencies in their handling of late 

comments. It is the policy of the DEA 

that comments not properly filed, e.g., 

comments postmarked after the close of 

a comment period, will not be 

considered by the agency in its 

deliberative process. Accordingly, the 

late comment from the foreign NRM 

manufacturer was not considered by 

DEA in this Final Rule. All comments 

received during the comment period are 

summarized here and discussed further 

below. 

Comments in Support of DEA’s NPRM 

Four of the commenters supported the 

proposed rule. These commenters 

included the Government of Spain, a 

DEA registered NRM importer, one 

foreign NRM manufacturer, and a DEAregistered opiate manufacturer. One of 

the DEA registrants commented that the 

need to ensure an adequate number of 

sources of NRM for DEA-registered 

NRM importers is ‘‘most keenly felt in 

CPS–T and CPS–O, for which the U.S. 

demand is rapidly growing and in 

which global supply sources to the U.S. 

are currently quite limited.’’

Comments Raising Concerns to DEA’s 

NPRM 

Nine of the commenters raised 

various concerns regarding the NPRM. 

These commenters included the 

Government of Australia, the 

Government of Macedonia, and the 

Government of Turkey; a foreign NRM 

control board; two DEA-registered 

importers of NRM; one non-DEAregistered firm; one foreign NRM 

manufacturer; and one individual. 

Four commenters claimed that the 

proposed rule would exacerbate current 

global oversupplies of NRM and 

therefore disrupt the balance between 

the supply of and demand for NRM. 

Three commenters claimed that the 

proposed rule was not consistent with 

the intent of the 80/20 rule or 

international resolutions. Three 

commenters claimed that the proposed 

rule was not necessary to assist the 

United States in maintaining cost 

effective supplies of NRM. Three 

commenters questioned DEA’s decision 

to replace Yugoslavia with Spain. 

The following additional concerns 

were raised. One commenter believed 

that the addition of Spain to the list of 

non-traditional NRM producing 

countries would lead to a proliferation 

of NRM-producing countries. The 

commenter, however, did not provide 

further information as to how this 

rulemaking would specifically lead to a 

proliferation of NRM-producing 

countries. Additionally, one commenter 

claimed that Spain has diversion 

occurring within its borders and that it 

could not be proven that the addition of 

Spain to the list of non-traditional 

countries would not lead to an increase 

in diversion within Spain. While the 

commenter provided a general 

statement regarding the diversion of 

controlled substances, the commenter 

did not provide any specific evidence 

regarding the diversion of narcotic raw 

material specifically cultivated for 

lawful purposes in Spain. Due to the 

lack of substantiation for the claims 

discussed above, these comments are 

not addressed further in this 

rulemaking. 

Request for Hearing 

Four commenters requested that DEA 

hold an administrative hearing in this 

matter. Two of these commenters 

requested a hearing prior to the issuance 

of the final rule. One of these 

commenters stated that a hearing was 

appropriate ‘‘given the gravity and 

complexity of the issues involved.’’ The 

other commenter stated that a hearing 

would ‘‘provide interested parties with 

the fullest opportunity to make their 

views known and have their positions 

considered.’’ These commenters did not 

proffer any specific information beyond 

that submitted in the written comments, 

however, that would be brought to light 

if their requests for a hearing were 

granted. DEA has determined that an 

oral hearing prior to the issuance of this 

rule is unnecessary. The amendment of 

the 80/20 rule to substitute one nontraditional country for another that no 

longer exists in the form it did at the 

time of the promulgation of the original 

rule does not represent a major change 

in DEA policy or procedure. Moreover, 

DEA has carefully considered all of the 

comments received in connection with 

the proposal, and finds that the 

comments fully set forth the issues 

relevant to this rulemaking. Based on 

information provided in the comments, 

information provided in technical 

reports by the International Narcotics 

Control Board (INCB), and information 

provided by U.S. importers of NRM 

pursuant to DEA regulations, DEA has 

been able fully to address the relevant 

issues set forth in the comments and has 

determined that conducting a hearing 

would not materially add to the 

administrative record. DEA has 

concluded, therefore, that such a 

hearing would be unnecessary. 

Two other commenters requested a 

hearing following the issuance of the 

final rule, if it is issued. Such a request 

does not conform procedurally with 

traditional rulemaking procedures 

under the APA, under which—if an 

agency holds a hearing in connection 

with a proposed rule—it is held prior to 

the issuance of the final rule. Moreover, 

neither the CSA nor DEA regulations 

provide for an administrative hearing to 

‘‘appeal’’ the promulgation of a final 

rule. Pursuant to 21 U.S.C. 877, 

exclusive jurisdiction for appeals of 

DEA final decisions such as this rule 

rests with the United States Courts of 

Appeals. Accordingly, the requests for a 

hearing if the final rule is issued are 

denied. 


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3Percentages may not add to 100 percent due to 

rounding. 

4 Ibid. 

5As discussed previously, The 80/20 rule is 

calculated based on the amount of morphine 

alkaloid contained in the NRM. As this discussion 

relates to the amount of thebaine alkaloid in the 

NRM, not morphine, the 85 percent obtained by the 

United States from Australia does not violate 

principles of the 80/20 rule. 

Other Comments Received 

One of the commenters wrote that if 

the proposal sought to change the 

method by which the 80/20 rule was 

calculated, then the commenter would 

object to the proposed rule. As noted 

previously, the 80/20 rule is calculated 

based on the amount of morphine 

alkaloid contained in the NRM. Since 

DEA’s proposed rule and this 

rulemaking do not affect how the 80/20 

rule is calculated, this matter is not 

addressed further in this rulemaking. 

One commenter submitted two 

comments. One of these comments 

stated, ‘‘So we are deciding who to 

allow to do the exporting of substances 

that are used to make heroin? We allow 

this? And then kick down the doors of 

terminally ill patients who smoke 

marijuana just to ease their 

pain.***’’ The other comment 

promoted the use of hallucinogens. 

NRM imported into the United States 

pursuant to this rule are used to make 

legitimate medicines that are used to 

treat pain, not to manufacture heroin. 

Heroin production and the use of 

marijuana and hallucinogens are not the 

subject of this rulemaking; these matters 

are therefore not addressed further in 

this rulemaking. 

Support for DEA’s NPRM 

Adequate Supply of NRM 

Three commenters addressed the need 

to ensure adequate supplies of NRM for 

United States markets. One commenter 

noted that the need to ensure an 

adequate number of sources of NRM for 

DEA registered NRM importers was 

‘‘most keenly felt in CPS–T and CPS–O, 

for which the U.S. demand is rapidly 

growing and in which global supply 

sources to the U.S. are currently quite 

limited.’’

DEA Response: DEA agrees that 

United States sources of NRM are 

limited based on data it collects 

quarterly from DEA registered importers 

pursuant to 21 CFR 1304.31. The data 

collected in these reports include the 

relative amounts of morphine, codeine, 

thebaine and oripavine contained in 

each individual NRM import to the 

United States as reported by each of the 

five DEA registered NRM importers. In 

response to this comment, DEA 

conducted an analysis of the source of 

each of the primary alkaloids available 

in current NRM: morphine, thebaine 

and oripavine. DEA notes that, in 2006, 

imports of NRM had as their source, 

four of the seven countries authorized to 

export NRM to the United States, 

specifically India, Turkey, Australia and 

France. United States importers have 

not imported NRM from Poland or 

Yugoslavia since at least 1985, and 

imports from Hungary were minimal in 

the mid to late 1990s and have ceased 

altogether since 2002. No imports from 

Poland, Yugoslavia, or Hungary are 

anticipated in 2007. Since NRM contain 

a mixture of these alkaloids, DEA’s 

review of the NRM import situation 

(below) is expressed in terms of the 

amount of morphine, thebaine, and 

oripavine contained in imported NRM. 

Morphine: Morphine is the principal 

alkaloid in Indian opium and Turkish 

CPS–M and has historically been the 

principal alkaloid extracted from NRM 

in the United States. Morphine 

continues to be utilized in the United 

States for the manufacture of morphinebased pharmaceutical products; the 

manufacture of codeine, which is 

utilized to manufacture codeine-based 

pharmaceutical preparations and 

hydrocodone; and the manufacture of 

hydromorphone. Based on an analysis 

of information received for 2006, 

imports of NRM totaled 124,000 kg of 

morphine (124.0 metric tons (MT)), 

having the following countries as its 

source: Turkey (59.9 MT morphine; 48.3 

percent), India (43.9 MT morphine; 35.4 

percent), and Australia (20.4 MT 

morphine; 16.5 percent).3 When 

reviewing imports of morphine over the 

last 10 years (1997–2006), United States 

importers obtained commercial 

quantities of morphine from India, 

Turkey, and Australia, with lesser 

amounts obtained from France and 

Hungary. DEA concludes as a result that 

the United States has at least three 

geographically distinct countries from 

which morphine is obtained, each with 

large production capacity on which the 

United States could rely if any of those 

countries were to experience a hardship 

(i.e., crop failure, labor strife, etc.). 

Adding Spain would provide DEA 

registered importers with a fourth 

country from which to purchase NRM. 

Thebaine: Thebaine is the principal 

alkaloid in CPS–T. CPS–T is available to 

the United States market from Australia 

and France. Thebaine is also present in 

Indian opium at approximately one 

sixth the level of morphine, thus the 

amount of thebaine obtained from India 

is directly related to the amount of 

morphine that United States importers 

import from India. In the United States, 

thebaine is utilized for the manufacture 

of oxycodone, a schedule II controlled 

substance. More recently, oxycodone 

has been utilized for the manufacture of 

oxymorphone, another schedule II 

controlled substance. 

Oxycodone use in the United States 

has increased tremendously over the 

last 10 years. For example, the aggregate 

production quota for oxycodone, which 

represents the maximum amount that 

may be manufactured in the United 

States to meet the estimated medical, 

industrial, scientific, and research needs 

of the United States; for lawful export 

requirements; and the maintenance of 

reserve stocks, has increased over the 

last decade from 5,275 kg in 1997 to 

49,200 kg in 2006. The large increase in 

oxycodone use in the United States 

followed the approval and marketing in 

1995 of a high dose, single-entity, 

extended-release drug formulation 

known as OxyContin. Although DEA 

remains concerned over the diversion 

and abuse of OxyContin and other 

formulations that contain high doses of 

potent schedule II controlled 

substances, the Food and Drug 

Administration continues to advise DEA 

of double-digit growth in the oxycodone 

market through 2008. This provides 

evidence that the demand for thebainerich NRM that must be imported into 

the United States for this purpose will 

also continue to increase. 

When the same 2006 quarterly 

statistical import data was reviewed for 

thebaine, DEA noted that 78.2 MT of 

thebaine was imported into the United 

States in 2006, having as its source the 

following countries: Australia (66.8 MT 

of thebaine; 85.4 percent), India (7.1 MT 

of thebaine; (9.1 percent), and France 

(4.1 MT of thebaine; 5.2 percent).4 Thus, 

Australia was the source of 85 percent 

of United States thebaine requirements 

in 2006.5 For comparison, in 2005, 73 

percent of the 65.4 MT of thebaine 

imported into the United States had 

Australia as it source, and, in 2004, 75 

percent of the 66.8 MT were imported 

from Australia. In 2007, United States 

importers have reported their plans to 

import 92 percent of their thebaine 

requirements from Australia; they 

planned to import the remaining 8 

percent solely from India. 

DEA notes that Australia has a stellar 

record in providing thebaine-rich NRM 

to the United States, with little (if any) 

record of diversion. DEA further notes 

that the United States and Australia 

have excellent relations in this area, and 

contrary to comments made by some 

commenters to this NPRM, DEA’s 

proposed rule and this final rule in no 


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way suggest that Australia has ‘‘not 

ensured an adequate and uninterrupted 

supply’’ of NRM to the United States. 

DEA remains mindful, however, of the 

potential impact of a hardship (i.e., crop 

failure, labor strife, etc.) in Australia 

that could lead to a temporary lack of 

availability of thebaine to the United 

States market. In this circumstance, the 

United States would be required to 

obtain much larger volumes of NRM 

from either India or France in order to 

meet thebaine demand. Although 

France has demonstrated the capability 

of exporting up to 16 MT of thebaine in 

a single year to the United States, 

India’s capacity to export thebaine, as 

mentioned above, is directly related to 

the amount of morphine that importers 

wish to import from India consistent 

with the 80/20 rule. Therefore, 

importing vast quantities of Indian 

opium to meet United States thebaine 

demands would be impractical because 

it would result in the importation into 

the United States of excessive amounts 

of morphine, which could then be the 

subject of diversion and abuse. Thus, 

the amount of thebaine that could be 

derived from India, consistent with 

United States requirements for 

morphine contained in Indian opium, is 

likely to be 6–8 MT annually. DEA 

concludes that the United States has 

limited sources from which to obtain 

thebaine derived from NRM. The United 

States relies on three countries for 

thebaine, but two of these countries 

have a limited capacity to support the 

increasing size of the United States’

market for thebaine. DEA notes that, in 

2004, the Government of Spain reported 

for the first time commercial production 

of CPS–T, so Spain would represent a 

fourth country from which CPS–T could 

be imported. As a result, this rule will 

provide DEA registered importers with 

another source from which to purchase 

CPS–T for the production of medicines. 

Oripavine: Oripavine, a schedule II 

controlled substance, is the principal 

alkaloid found in Australian CPS–O and 

is a minor constituent in French CPS–

T. Oripavine is becoming an 

increasingly important intermediate in 

the United States for the manufacture of 

buprenorphine, a schedule III controlled 

substance, oxymorphone, and a number 

of controlled and non-controlled 

substances referred to generally as 

‘‘opiate antagonists’’ (naltrexone for 

example, and its derivatives). Using the 

same import data, DEA notes that, in 

2006, 9.7 MT of oripavine was imported 

into the United States having Australia 

as its source, virtually 100 percent of the 

United States’ oripavine requirements. 

In 2005, 4.1 MT were imported from 

Australia and in 2004, 9.4 MT were 

imported with roughly 86 percent 

imported from Australia. United States 

importers have reported their plans to 

import 100 percent of the 9.7 MT of 

oripavine from Australia in 2007. DEA 

therefore concludes that the United 

States has limited sources from which to 

obtain oripavine derived from NRM. 

Objections to DEA’s NPRM 

Global Oversupply of Narcotic Raw 

Materials 

The Government of Australia’s 

primary concern regarding DEA’s 

proposed rule is that this rule would 

‘‘exacerbate global oversupply’’ of NRM. 

In its comment, the Government of 

Australia pointed to statistical data 

published by the INCB in its report, 

‘‘Narcotic Drugs: Estimated World 

Requirements for 2006—Statistics for 

2004,’’ which the Government of 

Australia characterized as 

demonstrating that global production of 

both morphine-rich and thebaine-rich 

NRM have been in excess of global 

utilization since at least 2001. As a 

result of overproduction, the 

Government of Australia argued, global 

supplies have increased. 

The DEA-registered NRM importer 

stated that ‘‘Alcaliber [the sole Spanish 

poppy cultivator] made a significant 

investment in capacity, dramatically 

increased production contributing 

significantly to global overproduction 

and excess stocks, and now wants 

access to the U.S. market to allow it to 

increase production further to help 

recover its investment.’’ The importer 

further stated that the Notice of 

Proposed Rulemaking sent the message 

that ‘‘If a country adds production 

capacity, uses it aggressively and 

thereby contributes to the world’s build 

up of excess stocks, the U.S. will 

accommodate this behavior and reward 

it with access to the U.S. market. The 

U.S. will simply delete a smaller 

producer from the list.’’ This commenter 

also stated that ‘‘Spain was arguably the 

primary source of this build up in 

excess morphine stocks.’’

Finally, the foreign opiate 

manufacturer stated that ‘‘Spain’s rapid 

expansion of its domestic industry, its 

aggressive approach to building export 

markets, its building of clearly excessive 

stockpiles and capacity, and supply into 

a market already in over-supply is not 

* * * broadly in accordance with the 

obligations under the Single 

Convention, or the Resolutions.’’

DEA Response: DEA disagrees that 

Spain is the ‘‘primary’’ source of any 

build-up of global excesses in morphine 

stocks. Instead, DEA concludes that all 

countries that produce NRM contribute 

to the current global excess of NRM. 

Among many of the requirements of 

NRM-producing countries, in 

accordance with the Single Convention 

on Narcotic Drugs, 1961, is a 

requirement to provide annual statistics 

to the INCB, including estimated 

amounts of NRM to be cultivated and 

the amount of NRM to be produced 

therefrom. The INCB utilizes these 

estimates along with other statistical 

data it collects, in accordance with the 

Single Convention, to monitor and 

analyze the global supply of and 

demand for NRM. The results of this 

analysis are published in a technical 

report series, which in 2004 was 

entitled, ‘‘Narcotic Drugs: Estimated 

World Requirements for 2006; Statistics 

for 2003.’’ The analysis conducted by 

the INCB and the statistical reports 

published continue to be an excellent 

resource for governments of consumer 

countries such as the United States. A 

review of this report series for 2004 and 

2005 was conducted with relevant 

statistical data provided in Tables 1 and 

2. 

Analysis for Morphine-Rich Poppies 

TABLE 1.—‘‘GLOBAL CULTIVATION OF MORPHINE-RICH POPPIES (HECTARES) FOR LICIT PURPOSES OTHER THAN

PRODUCTION OF OPIUM’’

Country 2003 

(ha) 

2004 

(ha) 

2005 

(ha-est.) 

2006 

(ha-est.) 

Australia ........................................................................................................................... 9,811 6,644 6,700 4,900 

People’s Republic of China ............................................................................................. 1,250 1,000 1,300 1,200 

Czech Republic ................................................................................................................ 21,045 16,030 25,000 38,000 

France .............................................................................................................................. 7,919 8,312 8,500 9,100 

Hungary ........................................................................................................................... 2,937 7,084 14,000 12,000 

Slovakia ........................................................................................................................... 332 326 550 ....................


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TABLE 1.—‘‘GLOBAL CULTIVATION OF MORPHINE-RICH POPPIES (HECTARES) FOR LICIT PURPOSES OTHER THAN

PRODUCTION OF OPIUM’’—Continued 

Country 2003 

(ha) 

2004 

(ha) 

2005 

(ha-est.) 

2006 

(ha-est.) 

Spain ................................................................................................................................ 5,732 5,986 7,002 6,002 

Republic of Macedonia .................................................................................................... 51 91 1,500 1,500 

Turkey .............................................................................................................................. 99,430 30,343 70,000 70,000 

United Kingdom ............................................................................................................... 1,534 1,534 1,500 ....................

Total .......................................................................................................................... 150,041 77,350 136,052 142,702 

Neither DEA, nor any commenter, 

identified a single instance in these 

reports in which the INCB raised 

concerns over Spain’s purported role in 

the global excess of production and the 

resulting oversupply of NRM presently 

on hand. According to this publication, 

Spain was one of eleven countries that 

cultivated morphine-rich poppies in 

2003 for licit pharmaceutical purposes 

(i.e. non-culinary use). Spain planted 

5,732 hectares of poppies and produced 

roughly 4.7 percent of the world’s 

morphine-rich poppy straw. Spain’s 

share of world production of poppy 

straw increased in 2004 to 10.7 percent; 

the increase was attributed to both an 

increase in 2004 acreage sown in Spain 

and a large decrease in acreage sown by 

the primary cultivator of poppies for 

this purpose, Turkey. Estimates for the 

‘‘area to be cultivated’’ for 2005 and 

2006 suggest that Spain will be 

responsible for 5.1 percent of the area 

under cultivation and had plans to 

decrease its area under cultivation in 

2006 to 4.2 percent. 

Although Spain remains one of the 

five largest cultivators of morphine-rich 

poppies in the world, DEA concludes 

that Spain, like all other producer and 

consumer countries, contributes to what 

the INCB qualifies as a ‘‘high’’ level of 

stocks of raw materials rich in 

morphine. 

Analysis of Thebaine-Rich Poppies 

TABLE 2.—‘‘GLOBAL CULTIVATION OF THEBAINE-RICH POPPIES (HECTARES) FOR LICIT PURPOSES OTHER THAN

PRODUCTION OF OPIUM’’

Country 2003 

(ha) 

2004 

(ha) 

2005 

(ha-est.) 

2006 

(ha-est.) 

Australia ........................................................................................................................... 7,637 5,578 6,500 5,300 

People’s Republic of China ............................................................................................. 34 40 50 

France .............................................................................................................................. 1,499 1,007 1,100 1,000 

Spain ................................................................................................................................ .................... 996 500 1,000 

Total .......................................................................................................................... 9,170 7,581 8,140 7,350 

Australia is the principal cultivator of 

thebaine-rich poppies and is responsible 

for the vast majority of thebaine-rich 

CPS that is produced and imported into 

the United States. Although the INCB 

notes that production of thebaine-rich 

NRM exceeded demand substantially 

until 2002, DEA notes that the primary 

cultivators, Australia and France, began 

decreasing areas under cultivation in 

2003 and have made significant 

decreases since that time in order to 

bring production in line with 

utilization. Although Spain noted 

cultivation of thebaine-rich poppies for 

the first time in 2004, it is not 

responsible for excess production that 

resulted in excess supplies before then. 

Consistency With the 80/20 Rule and 

International Resolutions 

As stated in DEA’s Notice of Proposed 

Rulemaking, the 80/20 rule was 

promulgated following a resolution 

adopted by the United Nations’

Economic and Social Council (ECOSOC) 

in 1979. In response to the resolution in 

1979, DEA published an Advance 

Notice of Proposed Rulemaking (44 FR 

33695, June 12, 1979) and then a Notice 

of Proposed Rulemaking (45 FR 9289, 

February 12, 1980). The comments 

resulting from the Notice of Proposed 

Rulemaking led to an administrative 

hearing. On August 18, 1981, DEA 

published a final rule promulgating the 

80/20 rule (46 FR 41775). 

Objections to the current Notice of 

Proposed Rulemaking pointed to 

specific comments in the 1979 

resolution, the Notice of Proposed 

Rulemaking, the transcript of the 

administrative hearing, and 

considerations made by then-Acting 

Administrator Francis Mullen, Jr., in 

DEA’s 1981 Final Rule. 

The foreign opiate manufacturer 

stated that the 1979 ECOSOC resolution 

called on ‘‘importing countries to * * * 

take effective steps to support their 

traditional supplier countries’’ and 

urged ‘‘major producing and 

manufacturing countries to which have 

set up [sic] additional capacity in recent 

years to take effective measures to 

restrict substantially their production 

levels to assure a lasting balance 

between supply and demand and to 

prevent drug diversion to illicit 

channels.’’ The commenter believed that 

‘‘[a]llowing Spain to now enter the 

market directly contradicts and 

undermines the objective of the Current 

80/20 Rule, and rewards a country for 

engaging in the very conduct the 

Current 80/20 Rule, and the 

Resolutions, were intended to 

discourage or stop.’’

The DEA-registered NRM importer 

who filed objections to the NPRM 

provided a summary of the 

determinations of fact made by Francis 

Young, the Administrative Law Judge 

(ALJ) who presided over the hearing in 

1980; these findings were adopted by 

then-Acting Administrator Mullen when 

the final rule was promulgated. The 

DEA-registered importer provided the 

following summary of ALJ Young’s 

determinations of fact: ‘‘(1) DEA could 

lawfully promulgate the regulatory 

amendments limiting the importation of 

narcotic raw materials; (2) the 

Administrator of DEA could lawfully 


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6Resolution 1979/8 of the Economic and Social 

Council. ‘‘Maintenance of a world-wide balance 

between the supply of narcotic drugs and the 

legitimate demand for those drugs for medical and 

scientific purposes.’’

require that a major portion of the 

[NRM] imported into the United States 

be produced in India and Turkey while 

permitting the remainder of the U.S. 

needs to be imported from other 

countries which maintain adequate 

control; (3) such allocation would be in 

harmony with U.S. trade agreements 

and would not be inconsistent with 

Resolution 471 and 497; and (4) DEA 

staff should determine an allocation 

ratio based upon world market shares 

during a recent representative period.’’

This commenter further noted that the 

1981 final rule ‘‘established clearly 

stated criteria for selecting the other 

countries that could supply the United 

States market with NRM: (a) France, 

Hungary, Poland, and Yugoslavia 

‘provided the United States with [NRM] 

during the period 1975 through 1979 

and present alternate sources’ and 

Australia ‘was the source of material for 

which import permits had been 

requested during the time period’ and 

(b) Each country did ‘impose adequate 

controls over their production of 

narcotic raw materials in adherence to 

their obligations under the Single 

Convention’.’’

DEA Response: DEA disagrees with 

the commenters’ assessments that this 

rule is inconsistent with the intent of 

the 80/20 rule and international 

resolutions. DEA finds that the 

proposed rule is consistent with both 

the 1979 resolution and the 80/20 rule. 

Consistency with 1979 Resolution: 

The text of the 1979 resolution 

contained separate and distinct 

operative language for Governments of 

importing countries (i.e., the United 

States) and Governments of producer 

countries. The operative paragraph for 

importing countries: 

‘‘Urge[d] the Governments of the importing 

countries that have not already done so to 

take effective steps to support the traditional 

supplier countries and to give those countries 

all the practical assistance they can in order 

to prevent the proliferation of sources of 

production of narcotic raw materials for 

export[.]’’ 6

Neither DEA nor the commenters 

disagree that the United States meets the 

first prong of this operative paragraph, 

i.e., the support of ‘‘traditional supply 

countries,’’ by providing India and 

Turkey with access to at least 80 percent 

of the United States market for 

morphine contained in NRM. As has 

been stated throughout this rule, DEA 

remains committed to this obligation 

through its continued support of the 80/ 

20 rule. The commenter’s objections 

would, therefore, fall under United 

States’ obligations under the second 

prong of this operative paragraph, 

namely to give all practical assistance in 

preventing the proliferation of 

producing countries. Since it is not 

refuted that the Government of Spain 

has been engaged in the production of 

NRM since 1974, prior to international 

calls to prevent proliferation, DEA 

concludes that the Government of Spain 

is not a new or emerging participant in 

the global production of NRM. The 

addition of Spain to the 80/20 rule will 

not result in a proliferation of producer 

countries. DEA therefore concludes that 

this action is consistent with the 1979 

resolution. 

Consistency with the 80/20 rule: As 

stated in the proposed rulemaking and 

reaffirmed in this final rule, DEA 

concludes that adding Spain to the list 

of countries authorized to export NRM 

to the United States is consistent with 

the 80/20 rule. Specifically, adding 

Spain is consistent with the criteria 

established by then-Acting 

Administrator Mullen when 

establishing Yugoslavia, France, Poland, 

Hungary, and Australia as the list of 

non-traditional suppliers in 1981. In the 

1981 Final Rule, then-Acting 

Administrator Mullen stated: 

However, in view of the past commercial 

relations with certain other countries as 

sources of narcotic raw material supply and 

the desirability of preserving alternate 

sources of narcotic raw materials, it is 

appropriate to allow certain specific 

countries to compete for the U.S. narcotic 

raw materials market on a limited basis. 

These countries, France, Poland, Hungary 

and Yugoslavia have provided the United 

States with supplies of narcotic raw materials 

during the period 1975 and 1979 and 

represent appropriate alternate sources. 

Australia is included as well since it was the 

source of material for which import permits 

had been requested during that time period. 

In addition, we are presently persuaded that 

the nations mentioned above impose 

adequate controls over their production of 

narcotic raw materials in adherence to their 

obligations under the Single Convention. (46 

FR 41775). 

Then-Acting Administrator Mullen 

reaffirmed DEA’s obligations to preserve 

alternate sources of NRM for the United 

States market. In an effort to determine 

the sources from which NRM could be 

derived, he established the following 

two criteria in designating the list of 

alternate sources: (1) The country had to 

have supplied the United States with 

NRM for a period of five years prior to 

the resolution’s passage in 1979 and (2) 

the country had to have imposed 

adequate controls over the production of 

NRM consistent with its obligations 

under the Single Convention. In his 

decision, then-Acting Administrator 

Mullen created an exception to the first 

criterion; this exception allowed the 

Government of Australia to be added to 

the list of non-traditional suppliers. 

Specifically, then-Acting Administrator 

Mullen found that, if a country was not 

the source of imports during the period 

1975–1979, then the country had to be 

a source from which DEA-registered 

importers of NRM had requested 

authority to import. Although Australia 

did not export NRM to the United States 

during the period 1975–1979, it was 

added because DEA-registered NRM 

importers had expressed interest in 

importing from Australia and had 

submitted to DEA the required 

‘‘Application for Permit to Import 

Controlled Substances for Domestic 

and/or Scientific Purposes’’ (DEA–357) 

from Australia. 

Based on this exception, one could 

conclude that Spain, despite not having 

been a source of NRM to the United 

States from 1975–1979, could qualify 

consistent with the 80/20 rule if a DEAregistered importer had expressed its 

interest in importing from Spain by 

filing a DEA–357, requesting 

authorization to do so. DEA notes, 

however, that the filing of such an 

application by a DEA-registered 

importer at present would be 

inconsistent with DEA regulations, 

specifically the 80/20 rule, and would 

therefore be impractical. Instead, 

interest in importing NRM from Spain 

arose through this rulemaking; DEA 

notes that one DEA-registered NRM 

importer expressed its interest in 

importing NRM from Spain during the 

comment period. DEA also notes that, 

during routine annual discussions with 

its five DEA-registered NRM importers 

before the receipt of the petition from 

the Government of Spain, the majority 

expressed some degree of interest in 

importing from Spain. 

Neither the commenters nor DEA 

disagree with the statements of fact 

made by the Government of Spain that 

it has implemented a system of 

domestic controls for the handling of 

NRM that are consistent with the Single 

Convention; DEA concludes, as a result, 

that the second criterion has been 

satisfied. 

DEA finds that adding Spain to the 

list of non-traditional suppliers is 

consistent with the criteria established 

in 1981 by then-Acting Administrator 

Mullen and is therefore consistent with 

the 80/20 rule. 

Cost of Narcotic Raw Materials 

One DEA-registered importer of NRM 

stated that DEA’s Notice of Proposed 


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Rulemaking ‘‘will do little or nothing to 

improve adequacy of supply or the cost 

of NRMs for the U.S.’’ The Government 

of Australia, in its comments to the 

DEA’s proposed rule stated that 

‘‘Spain’s petition presents no evidence 

to justify a need for change on the basis 

of adequacy of supply nor the cost 

effectiveness of that supply’’ and that 

‘‘there is no real issue with cost.’’

Finally, the foreign opiate manufacturer 

stated that there is no evidence that the 

proposed rule would maintain costeffective supplies and that there is ‘‘no 

suggestion that current supplies are not 

cost effective.’’

DEA Response: DEA agrees that there 

is no evidence provided in the petition 

from Spain that the addition of Spain to 

the 80/20 rule would lead to more costeffective supplies of NRM. This remains 

an open question. DEA does not 

routinely collect information relating to 

the cost of NRM or the opiates 

manufactured therefrom. Some of the 

commenters, however, provided data 

that demonstrate that the costs of NRM 

have steadily declined over the last five 

years and are presently at ‘‘record 

lows.’’ For example, the DEA-registered 

importer of NRM that objected to the 

NPRM stated that the price of CPS–M 

from Turkey was $660 per kilogram in 

2001 and will be $300 per kilogram in 

2007. The same commenter noted that 

CPS–T was $825 per kilogram in 2001 

and will be $500 per kilogram in 2007. 

The foreign opiate manufacturer stated 

that, ‘‘taking the United States supply 

price in 2001 as a benchmark, the 2006 

average price of Thebaine to the United 

States has declined over 20%.’’ Given 

the increasing demand for thebaine, the 

foreign opiate manufacturer contends 

that a decrease in price suggests a 

‘‘robust competitive environment.’’

DEA disagrees with the implication 

made by the Government of Australia, 

however, in its statement that ‘‘Spain’s 

assertion that its inclusion would 

further an underlying policy objective of 

the 80/20 Rule by ensuring an adequate 

and reliable supply at a stable price is 

based on a premise that prices of NRM 

have not been stable.’’ DEA concludes 

instead that the prices of NRM are 

directly related to the global stocks of 

these materials, which for more than the 

last 5 years have been in excess of global 

demand. For example, in the 2005 INCB 

publication, ‘‘Narcotic Drugs: Estimated 

World Requirements for 2006—

Statistics for 2004,’’ the INCB reported 

that ‘‘global production of opiate raw 

materials rich in morphine exceeded 

global demand considerably during the 

period 2002–2004.’’ For opiate raw 

materials rich in thebaine, the INCB 

reported that ‘‘the total supply 

(production and stocks) continued to be 

above global demand also for thebainerich raw materials * * * and that the 

balance between supply and demand 

will continue to be positive.’’ DEA 

therefore concludes that the decrease in 

price noted by the commenters is more 

a function of excess supply rather than 

evidence of ‘‘robust competition,’’ for, 

as noted, Australia supplies the vast 

majority of the United States’ demand 

for thebaine. 

DEA further concludes that 

maintaining cost-effective supplies of 

NRM to the United States equates to 

striking a global balance between supply 

of and demand for NRM. For producer 

countries such as India, Turkey, 

Australia, France and Spain, this means 

reducing areas of cultivation in times 

when global supplies are in excess and 

increasing production (to the extent 

possible) if and when hardship arises in 

a producer country that results in global 

demand being in excess of supply. For 

consumer countries, such as the United 

States, this equates to: (1) Ensuring that 

there are an adequate number of sources 

from which to procure NRM during 

times in which supplies are not in 

excess, (2) communicating accurate 

estimates of United States requirements 

for NRM to authorized exporting 

countries, and (3) working with the 

international community, including the 

INCB, to ensure a global balance 

between supply and demand. 

Replacing Yugoslavia With Spain 

The Republic of Macedonia 

(Macedonia) forwarded a letter prepared 

by the only company licensed in 

Macedonia to purchase poppy straw and 

manufacture opiate alkaloids. The 

company raised concerns regarding 

DEA’s comment in the NPRM that ‘‘the 

successor states to the former 

Yugoslavia no longer produce NRM for 

export.’’ The company disagreed with 

this observation, stating that Macedonia 

has been ‘‘enjoying the rights arising out 

of the 80/20 rule for more than 25 

years.’’ The company therefore insisted 

that ‘‘Yugoslavia can only be replaced 

on the list with its legitimate successor 

state Macedonia.’’ A second commenter 

stated that DEA’s proposed rule sought 

to ‘‘replace Macedonia with Spain.’’

Finally, a third commenter stated that 

DEA ignored ‘‘the position of its 

[Yugoslavia’s] clear successor state, 

namely Macedonia.’’

DEA Response: DEA disagrees with 

those commenters that suggest that 

Macedonia is the de facto successor to 

Yugoslavia for purposes of the 80/20 

rule. Macedonia became a sovereign 

country only after the dissolution of 

Yugoslavia. As a new country, 

Macedonia cannot automatically replace 

Yugoslavia in the 80/20 rule. Macedonia 

is but one of five countries that were 

created after the dissolution of 

Yugoslavia in the early 1990s. Any one 

of the five countries would be required 

to petition DEA if it wished to be added 

to the list of countries authorized to 

export NRM. DEA would then be 

required to review the merits of any 

such petition in a manner consistent 

with DEA’s review of the petition filed 

by Spain. 

DEA also disagrees with Macedonia’s 

assessment that its manufacturers have 

‘‘enjoyed’’ the rights arising from the 80/ 

20 rule for the last 25 years. The 

company did not provide any statistical 

data to demonstrate previous sales to 

the United States or anticipated sales to 

the United States. In this regard, DEA 

conducted a review of import permits 

issued for NRM over the last five years 

and did not identify an occasion in 

which a United States importer 

requested authority to import NRM from 

Macedonia. Instead, according to the 

most recent statistics available from the 

INCB (statistics for 2004), Macedonia 

did not export opium, poppy straw, or 

concentrate of poppy straw from 2002 

through 2004. Instead, Macedonia 

reported the exportation of small 

quantities of morphine and codeine, 

schedule II controlled substances whose 

importation into the United States is 

generally regarded as being prohibited 

by DEA regulations unless specifically 

requested in limited quantities for use 

exclusively in scientific research (21 

CFR 1312.13). 

Conclusion 

Based on the comments received, 

statistical data on imports of NRM 

collected and analyzed by DEA 

pursuant to the Code of Federal 

Regulations, and reports from the INCB, 

DEA concludes that in order to continue 

to ensure an adequate supply of NRM 

necessary to meet the estimated 

medical, industrial, scientific, and 

research needs of the United States, for 

lawful export requirements, and for the 

maintenance of adequate stocks, it is 

appropriate to add Spain to the list of 

non-traditional countries permitted to 

export NRM to the United States. 

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. 

601–612), that he has reviewed this 

regulation, and by approving it certifies 


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that this regulation will not have a 

significant economic impact on a 

substantial number of small business 

entities. This rule imposes no new costs 

or burden on small entities. Rather, this 

rule adds Spain to the list of nontraditional countries permitted to export 

NRM to the United States, helping to 

ensure that United States importers and 

manufacturers will have access to, and 

be able to procure, supplies of NRM to 

meet legitimate United States medical, 

scientific, research, and industrial 

needs, to ensure maintenance of 

adequate reserve stocks, and to meet 

lawful export requirements. 

Additionally, this rule provides DEA 

registered importers with another source 

from which to purchase NRM which are 

utilized for the production of controlled 

substances used in the United States for 

medical purposes. 

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 rule meets the applicable 

standards set forth in Sections 3(a) and 

3(b)(2) of Executive Order 12988. 

Executive Order 13132 

This 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 rule will not result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $120,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed necessary under 

the provisions of the Unfunded 

Mandates Reform Act of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by Section 804 of the 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 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 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 amended by 

revising paragraphs (f) and (g) to read as 

follows: 

§ 1312.13 Issuance of import permit. 

* * * * * 

(f) Notwithstanding paragraphs (a)(1) 

and (a)(2) of this section, the 

Administrator shall permit, pursuant to 

section 1002(a)(1) or 1002(a)(2)(A) of the 

Act (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: January 30, 2008. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control. 

[FR Doc. E8–2142 Filed 2–5–08; 8:45 am] 

BILLING CODE 4410–09–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0280; FRL–8346–9] 

Clothianidin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of clothianidin in 

or on sugar beet roots, tops and 

molasses. Bayer CropScience requested 

this tolerance under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 6, 2008. Objections and 

requests for hearings must be received 

on or before April 7, 2008, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2007–0280. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (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 in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S–

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305–

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kable Bo Davis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 


yshivers on PROD1PC62 with RULES