Federal
Register Notices > Rules - 200 8
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Elimination of Exemptions for Chemical Mixtures Containing
the List I Chemicals Ephedrine and/or Pseudoephedrine
8
FR Doc E8-15704[Federal Register: July 10, 2008 (Volume
73, Number 133)] [Rules and Regulations] [Page 39611-39614] From
the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jy08-12]
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 ode@dea.usdoj.gov.
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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