Elimination of Exemptions for Chemical Mixtures Containing the List I Chemicals Ephedrine and/or Pseudoephedrine, 39611-39614 [E8-15704]
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Federal Register / Vol. 73, No. 133 / Thursday, July 10, 2008 / Rules and Regulations
materials needed to fully address all
deficiencies identified in the complete
response letter. A biologics license
application or supplement for which
FDA issued a complete response letter,
but which was withdrawn before
approval and later submitted again, is
not a resubmission.
PART 601—LICENSING
23. The authority citation for 21 CFR
part 601 continues to read as follows:
I
Authority: 15 U.S.C. 1451–1561; 21 U.S.C.
321, 351, 352, 353, 355, 356b, 360, 360c–
360f, 360h–360j, 371, 374, 379e, 381; 42
U.S.C. 216, 241, 262, 263, 264; sec. 122, Pub.
L. 105–115, 111 Stat. 2322 (21 U.S.C. 355
note).
§ 601.3
[Added]
24. Section 601.3 is added to subpart
A to read as follows:
I
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§ 601.3 Complete response letter to the
applicant.
(a) Complete response letter. The
Food and Drug Administration will
send the biologics license applicant or
supplement applicant a complete
response letter if the agency determines
that it will not approve the biologics
license application or supplement in its
present form.
(1) Description of specific
deficiencies. A complete response letter
will describe all of the deficiencies that
the agency has identified in a biologics
license application or supplement,
except as stated in paragraph (a)(2) of
this section.
(2) Inadequate data. If FDA
determines, after a biologics license
application or supplement is filed, that
the data submitted are inadequate to
support approval, the agency might
issue a complete response letter without
first conducting required inspections,
testing submitted product lots, and/or
reviewing proposed product labeling.
(3) Recommendation of actions for
approval. When possible, a complete
response letter will recommend actions
that the applicant might take to place its
biologics license application or
supplement in condition for approval.
(b) Applicant actions. After receiving
a complete response letter, the biologics
license applicant or supplement
applicant must take either of the
following actions:
(1) Resubmission. Resubmit the
application or supplement, addressing
all deficiencies identified in the
complete response letter.
(2) Withdrawal. Withdraw the
application or supplement. A decision
to withdraw the application or
supplement is without prejudice to a
subsequent submission.
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(c) Failure to take action. (1) FDA may
consider a biologics license applicant or
supplement applicant’s failure to either
resubmit or withdraw the application or
supplement within 1 year after issuance
of a complete response letter to be a
request by the applicant to withdraw the
application or supplement, unless the
applicant has requested an extension of
time in which to resubmit the
application or supplement. FDA will
grant any reasonable request for such an
extension. FDA may consider an
applicant’s failure to resubmit the
application or supplement within the
extended time period or request an
additional extension to be a request by
the applicant to withdraw the
application.
(2) If FDA considers an applicant’s
failure to take action in accordance with
paragraph (c)(1) of this section to be a
request to withdraw the application, the
agency will notify the applicant in
writing. The applicant will have 30 days
from the date of the notification to
explain why the application or
supplement should not be withdrawn
and to request an extension of time in
which to resubmit the application or
supplement. FDA will grant any
reasonable request for an extension. If
the applicant does not respond to the
notification within 30 days, the
application or supplement will be
deemed to be withdrawn.
Dated: June 26, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–15608 Filed 7–9–08; 8:45 am]
BILLING CODE 4160–01–S
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
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
AGENCY:
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
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39611
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
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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, Nmethylephedrine, 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
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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.
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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, Nmethylpseudoephedrine,
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
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Federal Register / Vol. 73, No. 133 / Thursday, July 10, 2008 / Rules and Regulations
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
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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
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39613
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
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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.
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Congressional Review Act
This Rule is not a major rule as
defined by Section 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act). This Rule will not result
in an annual effect on the economy of
$100,000,000 or more; a major increase
in costs or prices; or significant adverse
effects on competition, employment,
investment, productivity, innovation, or
on the ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
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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
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9413]
RIN 1545–BD19
Escrow Accounts, Trusts, and Other
Funds Used During Deferred
Exchanges of Like-Kind Property
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
AGENCY:
SUMMARY: This document contains final
regulations under section 468B of the
Internal Revenue Code (Code). The
regulations provide rules regarding the
taxation of income earned on escrow
accounts, trusts, and other funds used
during deferred like-kind exchanges of
property, and final regulations under
section 7872 regarding below-market
loans to facilitators of these exchanges.
The regulations affect taxpayers that
engage in deferred like-kind exchanges
and escrow holders, trustees, qualified
intermediaries, and others that hold
funds during deferred like-kind
exchanges.
Effective Date: These regulations
are effective July 10, 2008.
Applicability Dates: For dates of
applicability, see §§ 1.468B–6(f),
1.7872–5(d), and 1.7872–16(g).
FOR FURTHER INFORMATION CONTACT:
Concerning the final regulations under
section 468B, Jeffrey T. Rodrick, (202)
622–4930; concerning the final
regulations under section 7872, David B.
Silber, (202) 622–3930 (not toll-free
numbers).
DATES:
SUPPLEMENTARY INFORMATION:
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Background
This document contains amendments
to the Income Tax Regulations (26 CFR
part 1) regarding the taxation of
qualified escrow accounts, qualified
trusts, and other escrow accounts,
trusts, or funds used during section
1031 deferred exchanges of like-kind
property, and of below-market loans to
facilitators of these exchanges, under
sections 468B(g) and 7872.
On February 7, 2006, a partial
withdrawal of notice of proposed
rulemaking, a notice of proposed
rulemaking, and notice of public
hearing were published in the Federal
Register (REG–209619–93 and REG–
113365–04, 71 FR 6231). A public
hearing was held on June 6, 2006. A
revised Initial Regulatory Flexibility
Analysis (IRFA) for REG–113365–04
was published in the Federal Register
on March 20, 2007 (72 FR 13055).
Written and electronic comments
responding to the notice of proposed
rulemaking and the revised IRFA were
received. After consideration of all the
comments, the proposed regulations are
adopted as amended by this Treasury
decision. The comments and
amendments are discussed below.
Explanation of Provisions and
Summary of Comments
1. Definitions
The proposed regulations define
exchange funds as relinquished
property, cash, or cash equivalent that
secures an obligation of the transferee to
transfer replacement property, or
proceeds from a transfer of relinquished
property. A commentator suggested that
the definition of exchange funds as
relinquished property, cash, or cash
equivalent that secures an obligation of
the transferee to transfer replacement
property should be deleted as confusing
and unnecessary, because it is irrelevant
whether amounts held in a qualified
account or fund secure or are intended
to secure the obligations of the
transferee. The final regulations do not
adopt this comment. This definition of
exchange funds is necessary because it
encompasses transactions contemplated
in § 1.1031(k)–1(g)(3) in which, for
example, a transferee of the
relinquished property pays a deposit
before the property is transferred, or a
transferee of the relinquished property
agrees to transfer replacement property
and deposits funds to secure the
obligations of the transferee (see
§ 1.468B–6(e), Example 1). The
definition is an alternative to the
definition of exchange funds as
proceeds from a transfer of relinquished
property, and does not create a
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]]>Agencies
[Federal Register Volume 73, Number 133 (Thursday, July 10, 2008)]
[Rules and Regulations]
[Pages 39611-39614]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15704]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-284F]
RIN 1117-AB11
Elimination of Exemptions for Chemical Mixtures Containing the
List I Chemicals Ephedrine and/or Pseudoephedrine
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration (DEA) is finalizing,
without change, the Interim Rule with Request for Comment published in
the Federal Register on July 25, 2007 (72 FR 40738). The Interim Rule
removed the Controlled Substances Act (CSA) exemptions for chemical
mixtures containing ephedrine and/or pseudoephedrine with concentration
limits at or below five percent. Upon the effective date of the Interim
Rule, all ephedrine and pseudoephedrine chemical mixtures, regardless
of concentration and form, became subject to the regulatory provisions
of the CSA. DEA regulated the importation, exportation, manufacture,
and distribution of these chemical mixtures by requiring persons who
handle these chemical mixtures to register with DEA, maintain certain
records common to business practice, and file certain reports,
regarding these chemical mixtures. No comments to the Interim Rule were
received. This Final Rule finalizes the Interim Rule without change.
EFFECTIVE DATE: August 11, 2008.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug & Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, telephone (202) 307-
7183, fax (202) 353-1263, or e-mail 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
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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
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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
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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
