[Federal Register Volume 73, Number 133 (Thursday, July 10, 2008)]
[Rules and Regulations]
[Pages 39611-39614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15704]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[Docket No. DEA-284F]
RIN 1117-AB11


Elimination of Exemptions for Chemical Mixtures Containing the 
List I Chemicals Ephedrine and/or Pseudoephedrine

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is finalizing, 
without change, the Interim Rule with Request for Comment published in 
the Federal Register on July 25, 2007 (72 FR 40738). The Interim Rule 
removed the Controlled Substances Act (CSA) exemptions for chemical 
mixtures containing ephedrine and/or pseudoephedrine with concentration 
limits at or below five percent. Upon the effective date of the Interim 
Rule, all ephedrine and pseudoephedrine chemical mixtures, regardless 
of concentration and form, became subject to the regulatory provisions 
of the CSA. DEA regulated the importation, exportation, manufacture, 
and distribution of these chemical mixtures by requiring persons who 
handle these chemical mixtures to register with DEA, maintain certain 
records common to business practice, and file certain reports, 
regarding these chemical mixtures. No comments to the Interim Rule were 
received. This Final Rule finalizes the Interim Rule without change.

EFFECTIVE DATE: August 11, 2008.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, 
Drug & Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537, telephone (202) 307-
7183, fax (202) 353-1263, or e-mail [email protected].

SUPPLEMENTARY INFORMATION: 

Background

    On July 25, 2007 (72 FR 40738), the Drug Enforcement Administration 
(DEA) published an Interim Rule with Request for Comment removing the 
Controlled Substances Act (CSA) exemptions for chemical mixtures 
containing ephedrine and/or pseudoephedrine with concentration limits 
at or below five percent. Those chemical mixtures included dietary 
supplements containing the List I chemicals ephedrine or 
pseudoephedrine, which are regulated as chemical mixtures under the 
CSA. DEA had previously exempted these products from CSA regulatory 
control if the total concentration of the ephedrine and/or 
pseudoephedrine was at or below five percent, in an effort to reduce 
the regulatory burden on the dietary and nutritional supplement 
industry (68 FR 23195, May 1, 2003). However, on February 11, 2004, the 
Food and Drug Administration (FDA) issued a Final Rule (69 FR 6787) 
declaring dietary supplements containing ephedrine alkaloids 
adulterated under the Federal Food, Drug, and Cosmetic Act (the FFD&C 
Act) because these dietary supplements present an unreasonable risk of 
illness or injury. Effective April 12, 2004, the FDA rule prohibited 
the sale of dietary supplements containing ephedrine alkaloids such as 
ephedra (also known as Ma Huang, sida

[[Page 39612]]

cordifolia and pinellia). The effect of the FDA rule was to ban the 
lawful marketing of these products.
    DEA notes that the FDA ban addresses only the marketing of dietary 
supplements containing ephedrine alkaloids. The raw materials used to 
manufacture these dietary supplements are not restricted by the FDA 
ban. Accordingly, to control those materials, DEA needed to address the 
importation, exportation, manufacture, or distribution of chemical 
mixtures with concentration limits of ephedrine and/or pseudoephedrine 
at or below five percent. As there yet may be legitimate uses for 
chemical mixtures with concentration limits at or below five percent, 
the importation, exportation, manufacture, and distribution of these 
chemical mixtures (for purposes other than use in dietary supplements 
containing ephedrine alkaloids) are not prohibited by either FDA's ban 
regarding the marketing of such dietary supplements or by DEA law and 
regulations. Accordingly, as discussed in the Interim Rule (72 FR 
40738, July 25, 2007), DEA removed the exempt status of chemical 
mixtures containing ephedrine and/or pseudoephedrine with concentration 
limits at or below five percent.
    DEA recognizes that ephedra materials containing ephedrine and/or 
pseudoephedrine are used legitimately by practitioners of Traditional 
Chinese Medicine. This rulemaking does not restrict the utilization of 
such material for such legitimate purposes. This rulemaking will simply 
require importers and suppliers of such material to comply with DEA 
recordkeeping, registration, quota and import/export requirements.

Elimination of Exemption for Plant Material

    The Interim Rule also removed the exemption for DEA chemical 
mixture regulations for certain plant materials. Specifically, the 
ephedrine alkaloids, including, among others, ephedrine, 
pseudoephedrine, norephedrine, N-methylephedrine, norpseudoephedrine, 
N-methylpseudoephedrine, are chemical stimulants that occur naturally 
in some botanicals, but can be synthetically derived. The ingredient 
sources of the ephedrine alkaloids include raw botanicals (i.e., 
plants) and extracts from botanicals. Ma Huang, Ephedra, Chinese 
Ephedra, and epitonin are several names used for botanical ingredients, 
primarily from Ephedra sinica Stapf, Ephedra equisetina Bunge, Ephedra 
intermedia var. tibetica Stapf and Ephedra distachya Linne (the 
Ephedras), that are sources of ephedrine alkaloids (including ephedrine 
and pseudoephedrine.) Other plant sources that contain such ephedrine 
alkaloids include Sida cordifolia L. and Pinellia ternata (Thunb.) 
Makino. Common names that have been used for the various plants that 
contain ephedrine alkaloids include sea grape, yellow horse, joint fir, 
popotillo, and country mallow. As DEA discussed in its Interim Rule, 
although the proportions of the various ephedrine alkaloids in 
botanical species vary from one species to another, in most species 
used commercially, ephedrine is typically the predominant alkaloid in 
the raw material. In addition to chemical mixtures from synthetic 
sources, the Interim Rule removed the exemption for those plant sources 
that contain the ephedrine alkaloids, ephedrine and/or pseudoephedrine.
    The names desert herb, Squaw tea, Brigham tea, and Mormon tea refer 
to North American species of ephedra that do not contain ephedrine 
alkaloids but have been misused to identify ephedrine alkaloid 
containing ingredients. The Interim Rule did not pertain to species of 
ephedra that do not contain ephedrine and/or pseudoephedrine.

Combat Methamphetamine Epidemic Act of 2005

    On March 9, 2006, the President signed the Combat Methamphetamine 
Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT 
Improvement and Reauthorization Act of 2005. The CMEA mandates that DEA 
limit the domestic production and importation of materials containing 
ephedrine and pseudoephedrine (including ephedra) to quantities 
necessary for medical, scientific and other legitimate purposes (21 
U.S.C. 826 and 952(a)(1) as amended). As DEA discussed extensively in 
the Interim Rule, DEA is concerned about the illicit use of ephedra 
type material in the clandestine production of methamphetamine. While 
the legitimate market for dietary supplements containing such material 
has been cut by FDA's recent action, DEA observed an increasing number 
of requests for importation of below-five percent ephedrine and/or 
pseudoephedrine material. While there may be legitimate uses for these 
chemical mixtures, in light of FDA's action, DEA had become 
increasingly concerned about the intended purpose of such material, 
especially given that such material has been seized in clandestine drug 
laboratories.

Action Taken by the Interim Rule

    The Interim Rule published by DEA July 25, 2007 (72 FR 40738) 
removed the exemption for chemical mixtures having a total 
concentration of ephedrine and/or pseudoephedrine of five percent (or 
less). By removing these exemptions, all chemical mixtures containing 
ephedrine and/or pseudoephedrine became regulated chemical mixtures 
subject to control under the CSA, including registration, 
recordkeeping, reporting, and security controls. The rule also removed 
the exemption for the category of products consisting of harvested 
plant material meeting the definition of chemical mixture, even when 
the plant material is unaltered from its natural state, (i.e., ephedra) 
that contains ephedrine, N-methylephedrine, N-methylpseudoephedrine, 
norpseudoephedrine, phenylpropanolamine, and/or pseudoephedrine.
    The Interim Rule did not prohibit the importation, exportation, 
manufacture, or distribution of chemical mixtures containing ephedrine 
or pseudoephedrine in concentrations less than or equal to five 
percent. Rather, DEA regulated the importation, exportation, 
manufacture, and distribution of these chemical mixtures by requiring 
persons who handle these chemical mixtures to register with DEA, 
maintain certain records common to business practice, and file certain 
reports, regarding these chemical mixtures. Chemical mixtures 
containing the List I chemicals ephedrine and pseudoephedrine are still 
available for use.

Comments Received

    DEA did not receive any comments to its Interim Rule with Request 
for Comment (72 FR 40738, July 25, 2007) eliminating the exemption for 
chemical mixtures with concentration limits of the List I chemicals 
ephedrine and/or pseudoephedrine of less than or equal to five percent. 
Therefore, DEA is hereby finalizing that Interim Rule without change.

Provisions Specifically Applying to Regulated Chemical Mixtures 
Containing These List I Chemicals

    Effective August 24, 2007, any chemical mixture that contains 
ephedrine or pseudoephedrine is treated as a List I chemical. 
Transactions that meet or exceed the cumulative monthly threshold for 
the listed chemical, set forth at 21 CFR 1310.04, became regulated 
transactions. Persons interested in handling a regulated

[[Page 39613]]

mixture must comply with the following:
    Registration. Any person who manufactures, distributes, imports or 
exports a regulated mixture, or proposes to engage in such activities, 
with respect to a regulated mixture containing a List I chemical, shall 
obtain a registration pursuant to the CSA (21 U.S.C. 822). Regulations 
describing registration for List I chemical handlers are set forth in 
21 CFR part 1309.
    Separate registration is required for manufacture, distribution, 
importing, and exporting. A separate registration is required for each 
principal place of business at one general physical location where List 
I chemicals are manufactured, distributed, imported, or exported by a 
person (21 CFR 1309.23). Effective August 24, 2007, any person 
manufacturing, distributing, importing, or exporting any amount of a 
regulated mixture became subject to the registration requirement under 
the CSA. Recognizing that it is not possible for DEA to immediately 
issue registrations to all applicants, DEA established in 21 CFR 
1310.09 a temporary exemption from the registration requirement for 
persons desiring to engage in activities with regulated mixtures, 
provided that DEA received a properly completed application for 
registration on or before August 24, 2007. The temporary exemption for 
such persons will remain in effect until DEA takes final action on 
their application for registration.
    The temporary exemption applies solely to the registration 
requirement; all other chemical control requirements, including 
recordkeeping and reporting, were effective on August 24, 2007. 
Additionally, the temporary exemption does not suspend applicable 
federal criminal laws relating to the regulated mixture, nor does it 
supersede state or local laws or regulations. All handlers of a 
regulated mixture must comply with applicable state and local 
requirements in addition to the CSA regulatory controls.
    Records and Reports. The CSA (21 U.S.C. 830) requires certain 
records to be kept and reports to be made involving listed chemicals. 
Regulations describing recordkeeping and reporting requirements are set 
forth in 21 CFR part 1310. A record must be made and maintained for two 
years after the date of a regulated transaction involving a List I 
chemical. Only a distribution, receipt, sale, importation, exportation, 
brokerage, or trade of a regulated mixture above the established 
threshold is a regulated transaction (21 CFR 1300.02(b)(28)).
    Each regulated bulk manufacturer of a regulated mixture shall 
submit manufacturing, inventory, and use data on an annual basis (21 
CFR 1310.05(d)). Bulk manufacturers producing the mixture solely for 
internal consumption, e.g. formulating a nonregulated mixture, are not 
required to submit this information. Existing standard industry reports 
containing the required information are acceptable, provided the 
information is readily retrievable from the report.
    Further, 21 CFR 1310.05(a) requires that each regulated person 
shall report to DEA: (1) Any regulated transaction involving an 
extraordinary quantity of a listed chemical, an uncommon method of 
payment or delivery, or any other circumstance that the regulated 
person believes may indicate that the listed chemical will be used in 
violation of the CSA; (2) any proposed regulated transaction with a 
person whose description or other identifying characteristics the 
Administration has previously furnished to the regulated person; (3) 
any unusual or excessive loss or disappearance of a listed chemical 
under the control of the regulated person, and any in-transit loss in 
which the regulated person is the supplier; and (4) any domestic 
regulated transaction in a tableting or encapsulating machine. 21 CFR 
1310.03(c) requires that regulated persons who engage in a transaction 
with a nonregulated person or who engage in an export transaction that 
involves ephedrine or pseudoephedrine, including drug products 
containing these chemicals, and uses or attempts to use the Postal 
Service or any private or commercial carrier must file monthly reports 
of each such transaction.
    Imports/Exports. All imports/exports and brokered transactions of 
regulated mixtures containing ephedrine and/or pseudoephedrine shall 
comply with the CSA (21 U.S.C. 952, 957 and 971). Regulations for 
importation and exportation of List I chemicals are described in 21 CFR 
part 1313. Separate registration is necessary for each activity (21 CFR 
1309.22).
    Security. Regulated persons must provide effective controls and 
procedures to guard against theft and diversion of regulated mixtures 
through physical means or human or electronic monitoring. Regulated 
persons must store the regulated mixtures in containers sealed so that 
tampering will be evident; if the mixture cannot be stored in a sealed 
container, access to the chemicals must be controlled (21 CFR 1309.71).
    Administrative Inspection. Places, including factories, warehouses, 
or other establishments and conveyances, where regulated persons may 
lawfully hold, manufacture, or distribute, dispense, administer, or 
otherwise dispose of a regulated mixture or where records relating to 
those activities are maintained, are controlled premises as defined in 
21 CFR 1316.02(c). The CSA (21 U.S.C. 880) allows for administrative 
inspections of these controlled premises as provided in 21 CFR part 
1316 subpart A.

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Administrator hereby certifies that this rulemaking has 
been drafted in accordance with the Regulatory Flexibility Act (5 
U.S.C. 601-612) and by approving it certifies that this rule will not 
have a significant economic impact on a substantial number of small 
entities. This rule finalizes, without change, an Interim Rule with 
Request for Comment eliminating the exemption for chemical mixtures 
containing ephedrine and/or pseudoephedrine with concentration limits 
at or below five percent. DEA did not receive any comments to that 
Interim Rule.

Executive Order 12866

    The Deputy Administrator certifies that this rulemaking has been 
drafted in accordance with the principles in Executive Order 12866. It 
has been determined that this rule is not a ``significant regulatory 
action'' under Executive Order 12866, section 3(f), Regulatory Planning 
and Review, and accordingly this rule has not been reviewed by the 
Office of Management and Budget (OMB). This rule finalizes, without 
change, an Interim Rule eliminating the exemption for chemical mixtures 
containing ephedrine or pseudoephedrine with concentration limits at or 
below five percent. DEA did not receive any comments to its Interim 
Rule.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of state 
law; nor does it impose enforcement responsibilities on any state; nor 
does it diminish the power of any state to enforce its own laws. 
Accordingly, this rulemaking does not have federalism implications 
warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by state, local, and 
tribal

[[Page 39614]]

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.

Paperwork Reduction Act

    With publication of the Interim Rule (72 FR 40738, July 25, 2007), 
DEA eliminated the current exemption for chemical mixtures with 
concentration limits of the List I chemicals ephedrine and/or 
pseudoephedrine of less than or equal to five percent. This means that 
all chemical mixtures containing the List I chemicals ephedrine and/or 
pseudoephedrine are regulated chemical mixtures, regardless of 
concentration limits.
    Due to this change in the regulations, all persons who import, 
export, manufacture, or distribute chemical mixtures containing these 
two List I chemicals were required to register with DEA. They were also 
required to file reports regarding certain transactions, should certain 
criteria be met.
    As the impact of this regulation was minimal, DEA made minor 
revisions to the OMB information collections entitled ``Application for 
Registration Under Domestic Chemical Diversion Control Act of 1993 and 
Renewal Application for Registration under Domestic Chemical Diversion 
Control Act of 1993'' (OMB control number 1117-0031, DEA Form 510), 
``Report of Mail Order Transactions'' (OMB control number 1117-0033), 
and ``Import/Export Declaration for List I and List II Chemicals'' (OMB 
control number 1117-0023). DEA did not receive any comments regarding 
the number of persons who may be affected by this regulation. With 
publication of the Interim Rule, DEA received approval from the OMB to 
revise these information collections as discussed above.

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 foreign-based companies 
in domestic and export markets.

List of Subjects In 21 CFR Part 1310

    Drug traffic control, Exports, Imports, List I and List II 
chemicals, Reporting and recordkeeping requirements.

Adoption as Final Rule

    The Interim Rule amending part 1310 of Title 21 of the Code of 
Federal Regulations, which published in the Federal Register on July 
25, 2007, at 72 FR 40738, is hereby adopted as a Final Rule without 
change.

    Dated: June 27, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-15704 Filed 7-9-08; 8:45 am]
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