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Elimination of Exemptions for Chemical Mixtures Containing the List I
Chemicals Ephedrine and/or Pseudoephedrine
FR Doc E7-14295 [Federal Register: July 25, 2007 (Volume 72, Number 142)]
[Rules and Regulations] [Page 40738-40745] From the Federal Register Online
via GPO Access [wais.access.gpo.gov] [DOCID:fr25jy07-5]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-284I] 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: Interim rule with request for comments.
SUMMARY: This Interim Rule removes the Controlled Substances Act
(CSA) exemptions for chemical mixtures containing ephedrine and/or
pseudoephedrine with concentration limits at or below five percent. The Combat
Methamphetamine Epidemic Act of 2005 (CMEA) added additional controls on
ephedrine and pseudoephedrine and mandated that DEA limit the domestic
production and importation of materials containing ephedrine and
pseudoephedrine to quantities necessary for medical, scientific and other
legitimate purposes (21
U.S.C. 952(a)(1) as amended). DEA is eliminating
exemptions for these chemical mixtures. As such, all ephedrine and
pseudoephedrine chemical mixtures, regardless of concentration and form, shall
be subject to the regulatory provisions of the CSA.
DEA is not prohibiting the importation, exportation, manufacture, or
distribution of chemical mixtures containing ephedrine or pseudoephedrine in
concentrations less than or equal to five percent. Rather, DEA is regulating
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 will still be
available for use.
DATES: Effective August 24, 2007.
Persons seeking registration must apply on or before August 24, 2007 in
order to continue their business pending final action by DEA on their
application. Written comments must be postmarked, and electronic comments must
be sent, on or before September 24, 2007.
ADDRESSES: To ensure proper handling of comments, please reference "Docket
No. DEA-284I'' on all written and electronic correspondence. Written comments
being sent via regular mail should be sent to the Deputy Administrator, Drug
Enforcement Administration, Washington, DC 20537, Attention: DEA Federal
Register Representative/ODL. Written comments sent via express mail should be
sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL,
2401 Jefferson- Davis Highway, Alexandria, VA 22301. Comments may be sent
directly to DEA electronically by sending an electronic message to
dea.diversion.policy@usdoj.gov. Comments may also be sent electronically
through http://www.regulations.gov using the electronic comment form provided
on that site. An electronic copy of this document is also available at the
http://www.regulations.gov Web site. DEA will accept attachments to electronic
comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats
only. DEA will not accept any file format other than those specifically listed
here.
Posting of Public Comments: Please note that all comments received
are considered part of the public record and made available for public
inspection online at http://www.regulations.gov. Such information includes
personal identifying information (for example, name, address, etc.)
voluntarily submitted by the commenter. If you want to submit personal
identifying information (such as your name, address, etc.) as part of your
comment, but do not want it to be posted online, you must include the phrase "PERSONAL
IDENTIFYING INFORMATION'' in the first paragraph of your comment. You must
also place all the personal identifying information you do not want posted
online in the first paragraph of your comment and identify the information you
want redacted.
If you want to submit confidential business information as part of your
comment but do not want it to be posted online, you must include the phrase "CONFIDENTIAL
BUSINESS INFORMATION'' in the first paragraph of your comment. You must also
prominently identify confidential business information to be redacted within
the comment. If a comment has so much confidential business information that
it cannot be effectively redacted, all or part of that comment may not be
posted on http://www.regulations.gov.
Personal identifying information and confidential business information
identified and located as set forth above will be redacted and placed in the
agency's public docket file, and, where possible, posted online. If you wish
to inspect the agency's public docket file in person by appointment, please
see the FOR FURTHER INFORMATION paragraph.
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:
I. Background
Status of Dietary Supplements Containing Ephedrine and/or
Pseudoephedrine
Dietary supplements containing the List I chemicals ephedrine or
pseudoephedrine are regulated as chemical mixtures under the Controlled
Substances Act (CSA). DEA originally 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 rule prohibits the sale of dietary supplements containing ephedrine
alkaloids such as ephedra (also known as Ma Huang, sida 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 must address the importation,
exportation, manufacture, or distribution of chemical mixtures with
[[Page 40739]]
concentration limits of ephedrine and/or pseudoephedrine at or below five
percent. The importation, exportation, manufacture, and distribution of
chemical mixtures with concentration limits at or below five percent ephedrine
and/or pseudoephedrine are addressed by the CSA and its implementing
regulations. 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 further
below, for DEA to regulate the importation, exportation, manufacture, and
distribution of chemical mixtures containing ephedrine and/or pseudoephedrine
with concentration limits at or below five percent, DEA must remove these
chemical mixtures from their exempt status under CSA regulations.
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.
Plant Material Included in This Regulatory Action
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.
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, this rulemaking includes
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. This
rulemaking does not pertain to species of ephedra that do not contain
ephedrine and/or pseudoephedrine.
Combat Methamphetamine Epidemic Act of 2005 (CMEA)
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). 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 has seen an increasing number of requests for importation of
below-five percent ephedrine and/or pseudoephedrine material. DEA notes that
there may be legitimate uses for these chemical mixtures. However, in light of
FDA's action, DEA is concerned about the intended purpose of such material,
especially given that such material has been seized in clandestine drug
laboratories.
Chemical Mixture Regulatory Control History
The Chemical Diversion and Trafficking Act of 1988 (Pub. L. 100- 690) (CDTA)
was passed by Congress to curtail the diversion of specific chemicals used in
the illicit manufacture of controlled substances. The CDTA established
recordkeeping and reporting requirements necessary for DEA to identify and
track chemical diversion. While the CDTA achieved initial success in
curtailing the diversion of chemicals, traffickers soon found and took
advantage of certain shortcomings in the law. In the United States (U.S.),
traffickers were able to obtain needed supplies by purchasing products that
were exempted from regulation under the CDTA. Such products include chemical
mixtures.
Chemical Mixture Definition
The CDTA created a definition of "chemical mixture'' (21
U.S.C. 802(40)),
and exempted chemical mixtures from the definition of "regulated
transaction.'' (21 U.S.C. 802(39)(A)(vi) as amended by CMEA) Chemical mixtures
are defined as "a combination of two or more chemical substances, at least one
of which is not a list I chemical or a List II chemical, except that such term
does not include any combination of a List I chemical or a List II chemical
with another chemical that is present solely as an impurity.'' (21 U.S.C.
802(40))
Chemical Mixtures Containing Ephedrine and Pseudoephedrine
Ephedrine and pseudoephedrine are List I chemicals. Listed chemicals that
are classified as List I chemicals are important to the manufacture of
controlled substances. Chemical mixtures containing both these List I
chemicals include dietary and nutritional supplements. Prior to FDA's 2004
Final Rule, dietary and nutritional supplements containing both of these
chemicals were readily available in the U.S., commonly sold to the public in
drug and grocery stores, health and nutrition stores, and through direct
marketing campaigns. These dietary and nutritional supplements contained
ephedra plant material, or extracts from the ephedra plant. If these dietary
and nutritional supplements met certain criteria under the FFD&CA, they
were not recognized as drugs under the FFD&CA, but nonetheless were
considered to be chemical mixtures governed by DEA law and regulations. In
contrast, over-the-counter (OTC) and prescription drug products containing
these listed chemicals are not considered chemical mixtures (as long as they
are in final FDA approved labeled package form) and instead are specifically
addressed in 21 U.S.C. 802(39)(A)(iv) and (v) as amended by CMEA. Also see 21
CFR 1300.02(b)(28)(i).
Initial Chemical Mixture Controls
Prior to the Domestic Chemical Diversion Control Act of 1993 (DCDCA),
enacted in April of 1994, transactions involving all chemical mixtures
[[Page 40740]]
(including dietary supplements) were exempt from recordkeeping,
registration and other chemical regulatory control requirements of the CSA.
The DCDCA amended the CSA (21 U.S.C. 802(39)(A)(v)) to limit the application
of the above stated exemption and provided the Attorney General with the
authority to exempt a chemical mixture containing a listed chemical if it is "formulated
in such a way that it cannot be easily used in the illicit production of a
controlled substance'' and "the listed chemical or chemicals contained in the
mixture cannot be readily recovered.'' As such, only those chemical mixtures
meeting these criteria would be exempted from control. Until regulations which
delineated criteria and procedures for exempting specific chemical mixtures
were finalized, as a practical interpretation of the law, DEA treated all
chemical mixtures, including dietary and nutritional supplements, as being
exempt from the chemical regulatory requirements of the CSA. (Note that OTC
and prescription drug products are not considered chemical mixtures and are
addressed separately under 21
U.S.C. 802(39)(A)(iv)). Unless exempted pursuant
to law and regulations, the requirements for chemical mixtures included
registration for certain handlers of List I chemicals, recordkeeping,
reporting and security.
Concern Regarding Chemical Mixtures
Some chemical mixtures can be and have been used by traffickers in the
illicit manufacture of controlled substances. This exemption provided
traffickers with an unregulated source for obtaining these chemicals. To
address these problems, the DCDCA amended the exemption to provide that only
those chemical mixtures specified by regulation would be exempt from the
definition of "regulated transaction.''
Regulations regarding the exemption of chemical mixtures were initially
proposed by DEA on October 13, 1994 (59 FR 51888). In response to industry
concerns, the proposed regulations were withdrawn on December 9, 1994 (59 FR
63738). After consulting with the private sector and carefully considering
industry and other concerns, new regulations regarding chemical mixtures were
proposed on September 16, 1998 (63 FR 49506). The comment period, which was
twice extended, closed on April 16, 1999.
There are thousands of chemical mixtures in legitimate commerce, the
majority of which are not useful to the illicit laboratory operator. The NPRM
proposed criteria for the determination of whether a chemical mixture would be
automatically exempt from CSA regulatory controls. Additionally, the NPRM
defined an application process by which manufacturers may apply for an
exemption for chemical mixtures that do not qualify for automatic exemption.
The DEA proposed that each chemical be assigned a concentration limit that, if
found at or below the limit, will cause the mixture to be treated as exempt
from specific provisions of the CSA. This quantitative approach to identifying
regulated mixtures was considered necessary due to the complexity of
chemical-based commodities and the huge variety of products. These criteria
were expected to exempt the vast majority of chemical mixtures containing
listed chemicals from regulatory control. The NPRM included the proposed
creation of a "Table of Concentration Limits,'' in 21 CFR
1310.12. This table
lists the concentration limits for each listed chemical.
In recognition that not all mixtures that qualify for exemption can be
identified by concentration or category, the DEA also proposed an application
process to exempt additional mixtures which are not likely to be diverted for
use in the illicit production of controlled substances.
DEA originally proposed a concentration limit of two percent for chemical
mixtures containing ephedrine and/or pseudoephedrine. However, based on the
comments received from the NPRM (63 FR 49506, Sept. 16, 1998), DEA determined
that a five percent concentration limit would be more appropriate. On May 1,
2003, DEA published a Final Rule (68 FR 23195) which established a
concentration limit of five percent for chemical mixtures which contain
ephedrine and/or pseudoephedrine. If the concentration of the total ephedrine
and/or pseudoephedrine was at or below the five percent limit in a chemical
mixture, the mixture was automatically exempted from the registration,
reporting, recordkeeping and security requirements of the CSA. That Final Rule
primarily addressed those chemicals encountered in dietary and nutritional
supplements.
The May 1, 2003, Final Rule also established an exemption for the category
of products consisting of unaltered harvested plant material in 21 CFR
1310.12(d)(1). Finally, that rule provided for a process whereby a
manufacturer of a product which would otherwise be subject to regulation may
request an exemption for that specific product. This process allows chemical
mixtures not automatically exempt by the concentration limit to be considered
for exempt status under the CSA.
Recent FDA Action Pertaining to Dietary Supplements Containing Ephedrine
Alkaloids
In 2004, FDA issued a Final Rule declaring dietary supplements containing
ephedrine alkaloids "adulterated'' under the FFD&C Act (69 FR 6787,
February 11, 2004). FDA issued this rule after concluding that these products
present an unreasonable risk of illness or injury. FDA's Final Rule prohibits
the sale of these products and FDA has been seizing dietary supplements
containing ephedrine alkaloids since the Final Rule became effective in April
2004. The FDA Final Rule addressed the marketing of dietary supplements
containing ephedrine alkaloids; it did not address the importation,
exportation, manufacture or distribution of ephedrine and/or pseudoephedrine
chemical mixtures with concentration limits at or below five percent, if the
chemical mixture is not being marketed as a dietary supplement containing
ephedrine alkaloids. DEA notes that there yet may be legitimate uses for such
mixtures. As there yet may be legitimate uses for chemical mixtures with
concentration limits at or below 5 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. In spite of FDA's ban, and
corresponding reduction in legitimate need for these chemical mixtures, DEA
has seen a significant increase in the number of import requests for ephedra,
sparking a concern that these chemical mixtures are being diverted for use in
the illicit manufacture of methamphetamine.
Combat Methamphetamine Epidemic Act of 2005 (CMEA)
On March 9, 2006, the President signed the USA PATRIOT Improvement and
Reauthorization Act of 2005 which included the Combat Methamphetamine Epidemic
Act of 2005 (CMEA) (Title VII of Pub. L. 109- 177). The CMEA placed additional
controls on ephedrine and pseudoephedrine and tasked DEA with limiting the
domestic production and importation of ephedrine and pseudoephedrine materials
to quantities necessary for medical, scientific and other legitimate purposes
(21 U.S.C. 826 and
952(a)(1) as amended).
The CMEA imposed new requirements regarding the retail sale of scheduled
listed chemical products (products containing ephedrine,
[[Page 40741]]
pseudoephedrine, or phenylpropanolamine, that may be marketed or
distributed lawfully in the United States under the FFD&CA as
nonprescription products). In a separate rulemaking, "Retail Sales of
Scheduled Listed Chemical Products; Self-Certification of Regulated Sellers of
Scheduled Listed Chemical Products'' [Docket No. DEA-291, RIN 1117-AB05] (71
FR 56008, September 26, 2006; corrected at 71 FR 60609, October 13, 2006), DEA
promulgated regulations implementing these provisions. The CMEA also subjects
material containing ephedrine, pseudoephedrine and phenylpropanolamine to
manufacturing and import restrictions. Specifically, the CMEA requires that
importers of all listed chemicals provide DEA with information regarding the
transferee, (i.e., the downstream customer) of the chemical, as well as
information regarding the quantity of the chemical to be transferred.
Importers are further required to provide DEA with a return declaration
regarding each import after the transaction is completed (CMEA section 716, 21
U.S.C. 971(d) and (g), as amended). In a separate rulemaking, "Implementation
of the Combat Methamphetamine Epidemic Act of 2005; Notice of Transfers
Following Importation or Exportation'' [Docket No. DEA-292, RIN 1117-AB06] (72
FR 17401, April 9, 2007; Temporary Stay of Certain Provisions 72 FR 28601, May
22, 2007), DEA promulgated regulations implementing these provisions. Further,
the CMEA requires that the notice of importation (DEA Form 486) for ephedrine,
pseudoephedrine, and phenylpropanolamine "shall include all information known
to the importer on the chain of distribution of such chemical from the
manufacturer to the importer.'' (CMEA section 721, 21 U.S.C. 971(h) as
amended). In a separate rulemaking, "Information of Foreign Chain of
Distribution for Certain List I Chemicals'' [Docket No. DEA-295, RIN
1117-AB07], DEA is promulgating regulations to implement this provision.
Finally, the CMEA requires DEA to establish import and production quotas for
ephedrine, pseudoephedrine, and phenylpropanolamine (CMEA sections 713 and
715, 21 U.S.C. 826 and
952 as amended). In a separate rulemaking, "Import and
Production Quotas for Certain List I Chemicals'' [Docket No. DEA-293, RIN
1117-AB08] (72 FR 37439, July 10, 2007) DEA promulgated regulations to
implement these provisions.
DEA is removing the exemption for five percent ephedrine and/or
pseudoephedrine, in part, to fulfill the Congressional mandate of restricting
such material to quantities necessary for medical, scientific, and other
legitimate purposes (21 U.S.C. 826 and 952(a)(1) as amended). Without removing
the exemption for these products, DEA would be unable to effectively limit the
importation of ephedrine and pseudoephedrine, as required by the CMEA.
Present Concerns: Use at Illicit Laboratories
DEA is also authorized to remove an exemption for particular exempt
chemical mixtures if it finds evidence of diversion pursuant to 21 CFR
1310.12(e). This regulation provides that should DEA find such evidence, it
can "issue, and publish in the Federal Register, notification of the removal
of an exemption.'' Interested parties are invited to file written comments or
objections to the order within 60 days of the date of publication. If any
comment or objection raises "significant issues regarding any finding of fact
or conclusion of law upon which the order is based, [DEA] shall immediately
suspend the effectiveness of the order'' and reconsider the application for
exemption in light of the comments received.
At most methamphetamine laboratories seized in the U.S., the precursor
material was obtained via the diversion of OTC ephedrine or pseudoephedrine
products marketed in tablet and capsule form. While the vast majority of
products seized at illicit methamphetamine laboratories were OTC drug
products, ephedra and ma huang extracts containing ephedrine, N-methylephedrine,
N-methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and
pseudoephedrine, and dietary supplement products (containing ephedra and ma
huang extracts) have been seized. At this time, the frequency with which these
dietary supplement products and extracts are encountered is small. From 1998
through 2005, DEA has documented 20 methamphetamine laboratories where ephedra
materials have been seized. The source of precursor chemicals in a seized
clandestine laboratory is often not evident, so it is likely that the number
of seized laboratories that used such mixtures is actually greater. Ephedra,
therefore, can and is being diverted for use as a precursor material for the
illicit production of methamphetamine. Were DEA not to regulate chemical
mixtures containing ephedrine and/or pseudoephedrine at or below the current
five percent concentration limit, DEA is concerned that these products would
be more widely diverted for illicit production of methamphetamine,
particularly as traffickers look for easily-obtainable product due to the new
retail sales, quota and import restrictions imposed by CMEA.
DEA Concerns Regarding Recent Importations
Recently DEA has seen an increasing number of requests for importation of
large shipments of ephedra material in concentrations below the five percent
ephedrine and pseudoephedrine exemption limit. Traditionally, such ephedra
extract material has always been between 6- 8 percent ephedrine and/or
pseudoephedrine. As noted above, DEA has seen chemical mixtures with
concentration limits of ephedrine and/or pseudoephedrine at or below five
percent in clandestine methamphetamine laboratories. Subsequent to
implementing regulations which allowed an exemption for below five percent
material, DEA has witnessed increased ability of clandestine laboratory
operators to extract ephedrine and pseudoephedrine from various bulk materials
(including low concentration mixtures). These extraction procedures are shared
via the Internet. While these mixtures may contain low concentrations of
ephedrine and/or pseudoephedrine, they can be a ready source of supply for
methamphetamine traffickers.
Therefore, due to the existing clandestine methamphetamine laboratory
problem and the illicit use of extracts and dietary supplements (containing
ephedrine and related List I chemicals) as precursor material for the
clandestine production of methamphetamine, and the new limitations imposed by
the CMEA, DEA is removing the exemption for chemical mixtures having a total
concentration of less than (or equal to) five percent ephedrine or
pseudoephedrine and is removing the exemption for unaltered ephedra plant
material.
Action Taken in This Interim Rule
This Interim Rule announces the removal of 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 will be regulated chemical
mixtures subject to control under the Controlled Substances Act, including
registration, recordkeeping, reporting, and security controls. This action
will be effective August 24, 2007.
[[Page 40742]]
This rulemaking also removes the exemption for the category of products
consisting of harvested plant material which is specified in 21 CFR
1310.12(d)(1). Harvested plant material (i.e., ephedra) that contains
ephedrine, N-methylephedrine, N-methylpseudoephedrine, norpseudoephedrine,
phenylpropanolamine, and/or pseudoephedrine, meeting the definition of
chemical mixture, shall no longer be exempt from CSA provisions, even when the
plant material is unaltered from its natural state.
II. Provisions Specifically Applying to Regulated Chemical Mixtures
Containing These List I Chemicals
Effective August 24, 2007, any chemical mixture that contains ephedrine or
pseudoephedrine will be 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, shall be regulated transactions. Persons interested in
handling a regulated 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 will become subject to the
registration requirement under the CSA. DEA recognizes, however, that it is
not possible for persons who are subject to the registration requirement to
immediately complete and submit an application for registration and for DEA to
immediately issue registrations for those activities. Therefore, in order to
allow continued legitimate commerce in regulated mixtures, DEA is establishing
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 receives 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,
are effective on August 24, 2007. Therefore, all transactions of chemical
mixtures containing ephedrine or pseudoephedrine will be regulated, if at or
above threshold, while an application for registration or exemption is
pending. This is necessary because not regulating these transactions could
result in increased diversion of chemicals desirable to drug traffickers.
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.
21 CFR 1310.05 requires that each regulated person shall report to DEA any
regulated transaction involving an extraordinary quantity, an uncommon method
of payment or delivery, or any other circumstance that causes the regulated
person to believe that the listed chemical will be used in violation of the
CSA. Section
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.
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
Administrative Procedure Act
The Administrative Procedure Act (APA) generally requires that agencies,
prior to issuing a new rule, publish a notice of proposed rulemaking in the
Federal Register. The APA also provides, however, that agencies may be
excepted from this requirement when "the agency for good cause finds (and
incorporates the finding and a brief statement of reasons therefor in the
rules issued) that notice and public procedure thereon are impracticable,
unnecessary, or contrary to the public interest.'' 5 U.S.C. 553(b)(B).
With publication of this interim rule, DEA is invoking this "good cause''
exception to the APA's notice requirement based on the combination of several
extraordinary factors. Section 713 of the CMEA (21
U.S.C. 826 as amended)
requires the establishment of production quotas for the List I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine. DEA implemented these
requirements in a separate rulemaking, "Import and
[[Page 40743]]
Production Quotas for Certain List I Chemicals'' [Docket No. DEA-293, RIN
1117-AB08] (72 FR 37439, July 10, 2007). DEA cannot establish such quotas if
certain products containing these List I chemicals are not regulated. To not
regulate these products while at the same time establishing production quotas
would create a loophole which traffickers could exploit domestically. CMEA
also mandates that imports of ephedrine, pseudoephedrine, and
phenylpropanolamine are prohibited except for such quantities as the Attorney
General (DEA by delegation) finds necessary to provide for medical,
scientific, or other legitimate purposes (CMEA section 715, 21
U.S.C. 952 as
amended). DEA is further required to establish import quotas for these three
List I chemicals. In order for DEA to establish quotas and meet its obligation
to prohibit imports except those necessary to provide for a medical,
scientific, or other legitimate purpose, as required by the CMEA, DEA must
exercise regulatory control over chemical mixtures containing pseudoephedrine
and ephedrine. To exercise this control, DEA must eliminate the exemption for
chemical mixtures containing these List I chemicals.
DEA is concerned about the increasing number of requests for importation of
below-five percent ephedrine or pseudoephedrine material. After the recent FDA
action which bans dietary supplements containing such material, DEA has not
been able to determine the legitimate need for importation of such material.
Therefore, in an effort to eliminate the undocumented importation and domestic
distribution of such material, and to comply with all of the new requirements
imposed by the CMEA discussed above, DEA is removing these exemptions.
As has been discussed previously in this rulemaking, DEA has seized
chemical mixtures containing ephedrine and/or pseudoephedrine with
concentrations of less than five percent at 20 domestic clandestine
laboratories over the past several years. The source of precursor chemicals in
a seized clandestine laboratory is often not evident, so it is likely that the
number of seized laboratories that used such mixtures is actually greater.
Further, the CMEA specifically prohibits all importation of ephedrine,
pseudoephedrine, and phenylpropanolamine except those quantities which the
Attorney General finds to be necessary for medical, scientific, and other
legitimate purposes. These seizures, coupled with the new requirements
limiting importation of ephedrine, pseudoephedrine, and phenylpropanolamine,
as well as the establishment of production and import quotas for these three
List I chemicals, necessitate that DEA remove the concentration limit for
these previously exempt chemical mixtures. Engaging in traditional notice and
comment rulemaking would prevent DEA from complying with the mandates of CMEA
to limit the importation and domestic production of these materials.
Were DEA not to regulate chemical mixtures containing ephedrine and/or
pseudoephedrine at or below the current five percent concentration limit, DEA
is concerned that these products would be more widely diverted for illicit
production of methamphetamine, particularly with the new quota and import
restrictions imposed by CMEA. Accordingly, DEA finds that it is impracticable
to conduct notice and comment rulemaking regarding the removal of the
exemption for chemical mixtures with concentration limits at or below the
current five percent limit. If DEA did not act in this manner, traffickers
would have ready access to chemical mixtures which DEA has demonstrated are
being used currently to illicitly manufacture methamphetamine. Allowing such
illicit manufacture to continue during the pendancy of rulemaking would be
contrary to the public interest and the intent of the Combat Methamphetamine
Epidemic Act of 2005. The broad scope of the new law, as well as the expedited
effective dates, is a clear reflection of Congress' concern about the nation's
growing methamphetamine epidemic and its desire to act quickly to prevent
further illicit use of these chemicals.
In light of these factors, DEA finds that "good cause'' exists to issue
this interim rule without engaging in traditional notice and comment
rulemaking. In so doing, DEA recognizes that exceptions to the APA's notice
and comment procedures are to be "narrowly construed and only reluctantly
countenanced.'' Am. Fed'n of Gov't Employees v. Block, 655 F2d 1153, 1156
(D.C. Cir. 1981) (quoting New Jersey Dep't of Envt. Prot. v. EPA, 626 F.2d
1038, 1045 (D.C. Cir. 1980)). Based on the totality of the circumstances
associated with the CMEA, DEA finds that invocation of the "good cause''
exception is justified.
Further, the APA also provides that, while agencies are generally required
to publish final rules at least 30 days before they become effective, they may
be exempt from this requirement as well "for good cause found and published
with the rule.'' 5 U.S.C. 553(d)(3). As discussed previously, DEA has recently
seen a significant increase in the number of requests for importation of large
quantities of these chemical mixtures. After the recent FDA action which bans
dietary supplements containing such material, DEA has not been able to
determine the legitimate need for importation of such material. DEA is
concerned about the potential illicit use of such material for clandestine
methamphetamine manufacture, particularly as traffickers look for
easily-obtainable product due to the retail sales limits recently imposed by
the CMEA. Delaying the effective date of this rule could provide a significant
loophole for domestic illicit methamphetamine manufacturers to take advantage
of for their illegal activities. Therefore, DEA finds good cause not to delay
the effective date of this rule.
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has been
drafted in accordance with the provisions of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 605(b)). The (RFA) applies to rules that are subject to notice and
comment. As explained above, DEA has determined that public notice and comment
are not necessary. Consequently, the RFA does not apply. DEA notes, however,
that as explained in the discussion under Executive Order 12866, the costs of
this rule are low, requiring only registration, maintenance of records,
reports on unusual transactions, thefts or losses, and mail order
transactions, and security. Other than the registration fee and the reports,
these requirements can generally be met by standard business practices.
DEA has determined that dietary supplements containing ephedrine alkaloids,
including bulk material used to formulate these supplements, are the principal
chemical mixtures that contain ephedrine and/or pseudoephedrine. Dietary
supplements containing such ephedrine alkaloids have been banned by FDA. Due
to (1) The CMEA mandate that DEA limit the domestic production and importation
of materials containing ephedrine and pseudoephedrine to quantities necessary
for medical, scientific and other legitimate purposes; (2) the elimination of
the previous lawful status of such products as dietary supplements; and (3)
the potential illicit use of such products as precursor material for illicit
production of methamphetamine, DEA is removing the exemption for low
concentration material, including harvested plant
[[Page 40744]]
material. This industry is comprised mainly of small businesses, as defined
by U.S. Small Business Administration (SBA) regulations (13 CFR part 121).
However, the lawful marketing of dietary supplements containing ephedrine
alkaloids has been banned by FDA. As such, this regulatory action is not
expected to impact any manufacturers whose product can still lawfully be
marketed under the FFD&CA. Persons who import or distribute chemical
mixtures containing ephedrine and/or pseudoephedrine at or below the
previously-exempt five percent concentration limit will be affected by this
rule. This rule will not have a significant economic impact on those persons.
However, DEA is seeking comment specifically regarding the potential impacts
of this regulation.
DEA is not prohibiting the importation, exportation, manufacture, or
distribution of chemical mixtures containing ephedrine or pseudoephedrine in
concentrations less than or equal to five percent. Rather, DEA is regulating
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 will still be
available for use.
Executive Order 12866
This regulation has been drafted and reviewed in accordance with Executive
Order 12866, section 1(b), Principles of Regulation. DEA has determined that
this rule is a "significant regulatory action'' under Executive Order 12866,
section 3(f), Regulatory Planning and Review, and accordingly this rule has
been reviewed by the Office of Management and Budget (OMB).
The rule will impose relatively low costs on regulated persons. Other than
the annual registration fee of $1,247, there are few costs associated with the
rule. The records required on regulated transactions can be met with standard
business records. Reports on unusual sales, thefts, and losses will be filed
infrequently by any one person. Those who sell covered mixtures and deliver
them to the end user through the mail or other delivery services will have to
file a monthly report. The monthly report requires only the registrant's name
and registration number, the purchaser's name and address, the shipping
address (if different), the name and quantity of the chemical, and the date of
shipment; all of this information is available from standard business and
shipping records. These reports may be filed electronically. The security
requirements do not exceed standard business practices for the protection of
both the security and quality of these products. DEA has not determined the
number of firms potentially affected by the rule, but does not expect it to be
high.
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
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
The Drug Enforcement Administration is eliminating 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 will be required to register with DEA. They will also be required to
file reports regarding certain transactions, should certain criteria be met.
DEA does, however, provide a mechanism whereby a person may seek an
exemption from these regulatory requirements for a specific chemical mixture,
if DEA determines that such a chemical mixture cannot be used by traffickers
to manufacture controlled substances illicitly.
DEA notes that the lawful marketing of dietary supplements containing this
material has been banned by FDA. As such, this regulatory action is expected
to impact no manufacturers, whose product can still lawfully be marketed under
the FFD&CA.
Therefore, as the impact of this regulation is minimal, DEA is making minor
adjustments 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 is
specifically seeking comment regarding the number of persons who may be
affected by this regulation.
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.
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES
[AMENDED]
- 1. The authority citation for part 1310 continues to read as follows:
Authority: 21
U.S.C. 802, 827(h),
830, 871(b),
890.
- 2. Section 1310.09 is amended by adding a new paragraph (j) to read as
follows:
Sec. 1310.09 Temporary exemption from registration.
* * * * *
(j) Each person required by section 302 of the Act (21
U.S.C. 822) to
obtain
[[Page 40745]]
a registration to manufacture, distribute, import, or export regulated
chemical mixtures which contain ephedrine, and/or pseudoephedrine, pursuant to
Sections 1310.12 and 1310.13, is temporarily exempted from the registration
requirement, provided that DEA receives a properly completed application for
registration or application for exemption on or before August 24, 2007. The
exemption will remain in effect for each person who has made such application
until the Administration has approved or denied that application. This
exemption applies only to registration; all other chemical control
requirements set forth in parts 1309,
1310, 1313, and
1315 of this chapter
remain in full force and effect. Any person who manufactures, distributes,
imports, or exports a chemical mixture whose application for exemption is
subsequently denied by DEA must obtain a registration with DEA. A temporary
exemption from the registration requirement will also be provided for these
persons, provided that DEA receives a properly completed application for
registration on or before 30 days following the date of official DEA
notification that the application for exemption has not been approved. The
temporary exemption for such persons will remain in effect until DEA takes
final action on their registration application.
- 3. Section 1310.12 is amended as follows:
- A. By revising the Table of Concentration Limits in paragraph (c) by
revising the entries for "Ephedrine, its salts, optical isomers, and salts
of optical isomers'' and "Pseudoephedrine, its salts, optical isomers, and
salts of optical isomers''; and
- B. By removing paragraph (d)(1) and redesignating paragraphs (d)(2)
through (d)(5) as paragraphs (d)(1) through (d)(4) as follows:
Sec. 1310.12 Exempt chemical mixtures.
* * * * *
(c) * * *
Table of Concentration Limits
|
DEA chemical code number
|
Concentration (percent)
|
Special conditions
|
List I Chemicals |
Ephedrine, its salts, optical isomers, and salts of optical
isomers.
|
8113
|
Not exempt at any concentration.
|
Chemical mixtures containing any amount of ephedrine and/or
pseudoephedrine, and their salts, optical isomers and salts of
optical isomers are not exempt due to concentration, unless
otherwise exempted.
|
Pseudoephedrine, its salts, optical isomers, and salts of
optical isomers.
|
8112
|
Not exempt at any concentration.
|
Chemical mixtures containing any amount of ephedrine and/ or
pseudoephedrine, and their salts, optical isomers and salts of
optical isomers are not exempt due to concentration, unless
otherwise exempted.
|
List II Chemicals |
Dated: July 2, 2007.
Michele M. Leonhart, Deputy Administrator.
[FR Doc. E7-14295 Filed 7-24-07; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
|