Rules - 2011
[Federal Register Volume 76, Number 128 (Tuesday, July 5, 2011)]
[Proposed Rules]
[Pages 39039-39041]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16800]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-342P]
RIN 1117-AB33
Establishment of a New Drug Code for Marihuana Extract
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
SUMMARY: The Drug Enforcement Administration (DEA) is proposing to
create a new Administration Controlled Substances Code Number ("Code
Number" or "drug code") under 21 CFR 1308.11 for "Marihuana
Extract." This Code Number will allow DEA and DEA-registered entities
to track quantities of this material separately from quantities of
marihuana. This in turn will aid in complying with relevant treaty
provisions.
Under international drug control treaties (administered by the
United Nations), some differences exist between the regulatory controls
pertaining to marihuana extract versus those for marihuana and
tetrahydrocannabinols. DEA has established separate Code Numbers for
marihuana and for tetrahydrocannabinols, but not for marihuana extract.
To better track these materials and better comply with treaty
provisions, DEA is proposing to create a separate Code Number for
marihuana extract under 21 CFR 1308.11(d)(36): "Marihuana Extract
meaning extracts that have been derived from any plant of the genus
cannabis and which contain cannabinols and cannabidiols." Such
extracts of marihuana would continue to be treated as schedule I
controlled substances.
DATES: Electronic comments must be submitted and written comments must
be postmarked on or before September 6, 2011. Commenters should be
aware that the electronic Federal Docket Management System will not
accept comments after midnight Eastern Time on the last day of the
comment period.
ADDRESSES: To ensure proper handling of comments, please reference
"Docket No. DEA-342" on all electronic and written correspondence.
DEA encourages all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that
site. An electronic copy of this document and supplemental information
to this proposed rule are also available at the http://www.regulations.gov Web site for easy reference. Paper comments that
duplicate the electronic submission are not necessary as all comments
submitted to http://www.regulations.gov will be posted for public
review and are part of the official docket record. Should you, however,
wish to submit written comments via regular or express mail, they
should be sent to the Drug Enforcement Administration, Attention: DEA
Federal Register Representative/ODL, 8701 Morrissette Drive,
Springfield, VA 22152.
FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion
Control, Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone (202) 307-7165.
SUPPLEMENTARY INFORMATION: 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 and in the DEA's public
docket. Such information includes personal identifying information
(such as your 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 or made available in the public docket, 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 or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be
[[Page 39040]]
posted online or made available in the public docket, 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
online or made available in the public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted,
and the comment, in redacted form, will be posted online and placed in
the DEA's public docket file. Please note that the Freedom of
Information Act applies to all comments received. If you wish to
inspect the agency's public docket file in person by appointment,
please see the "For Further Information" paragraph.
Background
As provided in 21 CFR 1308.03, each controlled substance or basic
class thereof is assigned a four digit Code Number that is used to
track quantities of the controlled substance imported and exported to
and from the United States. Additionally, DEA uses these Code Numbers
in establishing aggregate production quotas for basic classes of
controlled substances listed in schedules I and II as required by 21
U.S.C. 826.
Consistent with the Controlled Substances Act (CSA), the schedules
contained in the DEA regulations include marihuana (drug code 7360) in
schedule I. 21 CFR 1308.11(d)(23). This listing includes (unless
specifically excepted or unless listed in another schedule) any
material, compound, mixture, or preparation, which contains any
quantity of the substance, or which contains any of its salts, isomers,
and salts of isomers that are possible within the specific chemical
designation. Because the definition of marihuana in 21 U.S.C. 802(16)
includes both derivatives and preparations of marihuana, DEA until now
has used drug code 7360 for extracts of marihuana as well. In this
proposed rule, DEA is proposing that the new drug code 7350 be used for
extracts of marihuana.
Why a New Code Number Is Needed
The United Nations Conventions on international drug control treat
extracts from the cannabis plant differently than marihuana or
tetrahydrocannabinols. The creation of a new drug code in DEA
regulations for marihuana extracts will allow for more appropriate
accounting of such materials consistent with treaty provisions.
The Single Convention on Narcotic Drugs, 1961 ("Single
Convention") and the 1971 Convention on Psychotropic Substances
("Psychotropic Convention") provide for the international control of
marihuana constituents. Many of the CSA's provisions were drafted to
comply with these Conventions. The CSA includes schemes of drug
scheduling and procedures for adding, removing, and transferring drugs
among the schedules that are similar, in some ways, to those in the
Single Convention. With respect to those drugs that are subject to
control under the Single Convention, the CSA mandates that DEA control
such drugs at least as strictly as required by the Single Convention.
21 U.S.C. 811(d).
Somewhat similar to the CSA, the Single Convention controls
substances through four schedules. However, under the Single
Convention, the drugs that are subject to the most stringent controls
are in schedule IV. Another difference between the CSA and the Single
Convention is that, under the latter, a drug can be listed in more than
one schedule. Cannabis and cannabis resin are listed in both schedule
IV and schedule I of the Single Convention. Schedule I controls under
the Single Convention include requirements for import and export
authorization, licensing of manufacturers/distributors, recordkeeping
requirements, requirement for prescriptions for medical use, annual
estimate of needs, quotas, annual statistical reporting, and a
requirement that use be limited to medical and scientific purposes.
Schedule II of the Single Convention is similar in controls to schedule
I with a few exceptions, and schedule III is less restrictive. All
substances listed in schedule IV are also listed in schedule I. The
placing of a drug into both schedule I and schedule IV therefore
imposes the most stringent controls under the Single Convention.
Although cannabis and cannabis resin are listed in Schedules I and IV
of the Single Convention, cannabis extracts are listed only in Schedule
I.
Proposed Actions
DEA therefore proposes to update 21 CFR 1308.11(d) to include new
subparagraph (36) which would create a new Code Number in schedule I as
follows:
"(36) Marihuana Extract..................................... 7350
Meaning extracts that have been derived from any plant of the
genus cannabis and which contain cannabinols and cannabidiols."
The creation of a new drug code in DEA regulations for marihuana
extracts would allow for more appropriate accounting of such materials
consistent with treaty provisions. Such marihuana extracts remain in
schedule I. Firms registered to handle marihuana (under drug code 7360)
that also handle marihuana extracts, will need to apply to add the new
drug code 7350 to their existing DEA registrations and procure quotas
specifically for drug code 7350 each year.
Regulatory Compliance Analyses
Regulatory Flexibility Act
In accordance with the Regulatory Flexibility Act (5 U.S.C. 601-
612), the Administrator has reviewed this regulation and by approving
it certifies that this regulation will not have a significant economic
impact upon a substantial number of small entities. This rule proposes
the establishment of a new drug code for marihuana extracts. DEA
already registers persons handling marihuana extracts, but within
another already-established drug code. Thus, persons who handle these
marihuana extracts have already met DEA's registration, security, and
other statutory and regulatory requirements. The only direct effect to
registrants who handle marihuana extracts would be the requirement to
add the new drug code to their registration once the code is
established.
Executive Orders 12866 and 13563
This regulation has been drafted and reviewed in accordance with
the principles of Executive Orders 12866 and 13563. Although this rule
is not a "significant regulatory action" under Executive Order 12866
Section 3(f), it was submitted to the Office of Management and Budget
(OMB) and subsequently approved.
Executive Order 12988
This proposed regulation meets the applicable standards set forth
in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform to eliminate ambiguity, minimize litigation, establish clear
legal standards and reduce burden.
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
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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
$136,000,000 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 of 1995
This action does not impose a collection of information requirement
under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.
Executive Order 13175
This rule is not a policy that has Tribal implications under
Executive Order 13175. It will not have substantial direct effects on
one or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.
List of Subjects in 21 CFR Part 1308
Drug traffic control, Controlled substances.
For the reasons set out above, 21 CFR part 1308 is proposed to be
amended as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
1. The authority citation for part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b).
2. Section 1308.11 is amended by adding new paragraph (d)(36) to
read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(36) Marihuana Extract....................................... 7350
Meaning extracts that have been derived from any plant of the genus
cannabis and which contain cannabinols and cannabidiols.
* * * * *
Dated: June 14, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-16800 Filed 7-1-11; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
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