[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4410-09-P