[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Rules and Regulations]
[Pages 90194-90196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29941]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-342]
RIN 1117-AB33
Establishment of a New Drug Code for Marihuana Extract
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration is creating a new
Administration Controlled Substances Code Number 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. The DEA has previously established separate code
numbers for marihuana and for tetrahydrocannabinols, but not for
marihuana extract. To better track these materials and comply with
treaty provisions, DEA is creating a separate code number for marihuana
extract with the following definition: ``Meaning an extract containing
one or more cannabinoids that has been derived from any plant of the
genus Cannabis, other than the separated resin (whether crude or
purified) obtained from the plant.'' Extracts of marihuana will
continue to be treated as Schedule I controlled substances.
DATES: Effective: January 13, 2017.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion
Control, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Background
As provided in 21 CFR 1308.03, each controlled substance or basic
class thereof is assigned a four digit Administration Controlled
Substance Code Number (``Code number'' or ``drug code'') that is used
to track quantities of the controlled substance imported and exported
to and from the United States. Additionally, the 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 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, the DEA until
now has used drug code 7360 for extracts of marihuana. This final rule
finalizes a
[[Page 90195]]
July 5, 2011, Notice of Proposed Rulemaking (76 FR 39039) in which the
DEA proposed that a 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 treats
extracts from the cannabis plant somewhat differently than marihuana or
tetrahydrocannabinols. The creation of a new drug code in the 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 in a manner that will ensure the United States meets its
obligations under the Single Convention. 21 U.S.C. 811(d)(1).
Somewhat similar to the CSA, the Single Convention lists substances
in 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, a 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 under the Single Convention in order to
encompass the requirements mentioned above. In addition, as indicated,
the Single Convention imposes certain heightened measures of control
with respect to Schedule IV drugs. 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.
Comments
In response to the July 5, 2011, Notice of Proposed Rulemaking (76
FR 39039), the DEA received six submissions from five commenters. Three
of the comments raised issues relating to the medical use or legality
of marihuana/cannabis; these comments were not germane to the issues
addressed by this rulemaking. A fourth comment was merely a
clarification of a comment previously submitted.
One comment requested clarification of whether the new drug code
will be applicable to cannabidiol (CBD), if it is not combined with
cannabinols.
DEA response: For practical purposes, all extracts that contain CBD
will also contain at least small amounts of other cannabinoids.\1\
However, if it were possible to produce from the cannabis plant an
extract that contained only CBD and no other cannabinoids, such an
extract would fall within the new drug code 7350. In view of this
comment, the regulatory text accompanying new drug code 7350 has been
modified slightly to make clear that it includes cannabis extracts that
contain only one cannabinoid.
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\1\ Although it might be theoretically possible to produce a CBD
extract that contains absolutely no amounts of other cannabinoids,
the DEA is not aware of any industrially-utilized methods that have
achieved this result.
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Another comment from a pharmaceutical firm currently involved in
cannabinoid research and product development praised DEA's efforts to
establish a new drug code for marihuana extracts as a means to more
accurately reflect the activities of scientific research and provide
more consistent adherence to the requirements of the Single Convention.
However, the comment expressed concerns that the proposed definition
for the new drug code (i.e. ``meaning extracts that have been derived
from any plant of the genus Cannabis and which contain cannabinols and
cannabidiols'') is too narrow. The comment suggested that the broader
term ``cannabinoids'' be substituted for ``cannabinols and
cannabidiols.'' The comment pointed out that other constituents of the
marihuana plant may have therapeutic potential. The comment further
clarified that the broader term ``cannabinoid'' includes both
cannabinol-type compounds and cannabidiol-type compounds, as well as
cannabichromene-type compounds, cannabigerol-type compounds, and other
categories of compounds.
DEA response: DEA agrees with the commenter that the term
``cannabinoid'' would provide for a broader definition of marihuana
extract; however, use of the term ``cannabinoid'' necessitates that the
DEA clarify that the new marihuana extract category (drug code 7350) is
not intended to include ``cannabis resin'' as defined in the U.N.
Single Convention.
As discussed in the NPRM, a new drug code is necessary in order to
better account for these materials in accordance with treaty
obligations. The Single Convention placed ``cannabis'' and ``cannabis
resin'' under both Schedule I and IV of the Convention, the most
stringent level of control under the Convention. While ``cannabis
resin'' is extracted from ``cannabis,'' the Single Convention
specifically controls ``extracts'' separately. Extracts of cannabis are
controlled only under Schedule I of the Convention, which is a lower
level of control than ``cannabis resin.''
Accordingly, it is the DEA's intent to define the term ``marihuana
extract'' so as to exclude material referenced as ``cannabis resin''
under the Single Convention on Narcotics. ``Cannabis resin'' (regulated
under the CSA as a resin of marihuana) contains a variety of
``cannabinoids'' and will continue to be regulated as marihuana under
drug code 7360. The new drug code for marihuana extracts under 21 CFR
1308.11(d)(58) will exclude the resin. Cannabis resin and marihuana
resin remain captured under the drug code for marihuana (drug code
7360), thus differentiating this material from marihuana extracts (new
drug code 7350). This will maintain compliance with the Single
Convention.
Final Action
After careful consideration of all comments, the DEA is hereby
amending 21 CFR 1308.11(d) to include a new subparagraph (58) which
creates a new code number in Schedule I as follows:
``(58) Marihuana Extract--7350
``Meaning an extract containing one or more cannabinoids that
has been derived from any plant of the genus Cannabis, other than
the separated resin (whether crude or purified) obtained from the
plant.''
The creation of this new drug code in the DEA regulations for
marihuana extracts allows for more appropriate accounting of such
materials consistent with treaty provisions. Such marihuana
[[Page 90196]]
extracts remain in Schedule I. Entities registered to handle marihuana
(under drug code 7360) that also handle marihuana extracts, will need
to apply to modify their registrations to add the new drug code 7350 to
their existing DEA registrations and procure quotas specifically for
drug code 7350 each year.
Regulatory Analyses
Executive Orders 12866 and 13563, Regulatory Planning and Review, and
13563, Improving Regulation and Regulatory Review
This regulation has been drafted and reviewed in accordance with
the principles of Executive Orders 12866 and 13563. This rule is not a
significant regulatory action under Executive Order 12866.
Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate
drafting errors and ambiguity, minimize litigation, provide a clear
legal standard for affected conduct, and promote simplification and
burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of Executive Order 13132. The rule does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or the distribution of power
and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of Executive Order 13175. It does 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.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act (RFA), 5 U.S.C. 601-602, has reviewed this rule and by approving
it, certifies that it will not have a significant economic impact on a
substantial number of small entities. This rule establishes 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 will be the requirement to add the new drug code to
their registration. Therefore, DEA has concluded that this rule will
not have a significant effect on a substantial number of small
entities.
Unfunded Mandates Reform Act of 1995
On the basis of information contained in the ``Regulatory
Flexibility Act'' section above, DEA has determined and certifies
pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C.
1501 et seq., that this action would not result in any Federal mandate
that may result in the expenditure by State, local, and tribal
governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted for inflation) in any one year.
Therefore, neither a Small Government Agency Plan nor any other action
is required under provisions of the UMRA 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. This
action would not impose recordkeeping or reporting requirements on
State or local governments, individuals, businesses, or organizations.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
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 (CRA)). 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 for consumers, individual industries, Federal,
State, or local government agencies, or geographic regions; or
significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of U.S.-based companies to
compete with foreign based companies in domestic and export markets.
However, pursuant to the CRA, the DEA has submitted a copy of this
final rule to both Houses of Congress and to the Comptroller General.
List of Subjects in 21 CFR Part 1308
Drug traffic control, Controlled substances.
For the reasons set out above, 21 CFR part 1308 is amended as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
0
2. Section 1308.11 is amended by adding paragraph (d)(58) to read as
follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(58) Marihuana Extract--(7350)
Meaning an extract containing one or more cannabinoids that has
been derived from any plant of the genus Cannabis, other than the
separated resin (whether crude or purified) obtained from the plant.
* * * * *
Dated: December 7, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-29941 Filed 12-13-16; 8:45 am]
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