81_FR_90434 81 FR 90194 - Establishment of a New Drug Code for Marihuana Extract

81 FR 90194 - Establishment of a New Drug Code for Marihuana Extract

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 240 (December 14, 2016)

Page Range90194-90196
FR Document2016-29941

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.

Federal Register, Volume 81 Issue 240 (Wednesday, December 14, 2016)
[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Rules and Regulations]
[Pages 90194-90196]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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]
BILLING CODE 4410-09-P



                                             90194        Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Rules and Regulations

                                             FDA performs to monitor third-party                     third-party certification bodies, would               from quantities of marihuana. This, in
                                             certification bodies that are accredited                remain in effect.                                     turn, will aid in complying with
                                             by a recognized accreditation body                         (3) If payment is not received within              relevant treaty provisions.
                                             under § 1.662.                                          90 days of the payment due date, FDA                     Under international drug control
                                                                                                     will revoke the accreditation body’s                  treaties administered by the United
                                             § 1.710 How will FDA notify the public                  recognition under § 1.634(a)(4)(iii), and             Nations, some differences exist between
                                             about the fee schedule?
                                                                                                     provide notice of such revocation in                  the regulatory controls pertaining to
                                                FDA will notify the public of the fee                accordance with § 1.634.                              marihuana extract versus those for
                                             schedule annually. The fee notice will                     (c) An accredited third-party                      marihuana and tetrahydrocannabinols.
                                             be made publicly available prior to the                 certification body that fails to submit its           The DEA has previously established
                                             beginning of the fiscal year for which                  annual fee within 30 days of the due                  separate code numbers for marihuana
                                             the fees apply, except for the first fiscal             date will have its accreditation                      and for tetrahydrocannabinols, but not
                                             year in which this regulation is                        suspended.                                            for marihuana extract. To better track
                                             effective. Each new fee schedule will be                   (1) FDA will notify the third-party                these materials and comply with treaty
                                             adjusted for inflation and improvements                 certification body that its accreditation             provisions, DEA is creating a separate
                                             in the estimates of the cost to FDA of                  is suspended, electronically and in                   code number for marihuana extract with
                                             performing relevant work for the                        English. FDA will notify a recognized                 the following definition: ‘‘Meaning an
                                             upcoming year.                                          accreditation body, electronically and in             extract containing one or more
                                             § 1.715 When must a user fee required by                English, if the accreditation of one if its           cannabinoids that has been derived
                                             this subpart be submitted?                              third-party certification bodies is                   from any plant of the genus Cannabis,
                                                                                                     suspended. FDA will notify the public                 other than the separated resin (whether
                                               (a) Accreditation bodies applying for                                                                       crude or purified) obtained from the
                                                                                                     of the suspension on the Web site
                                             recognition and third-party certification                                                                     plant.’’ Extracts of marihuana will
                                                                                                     described in § 1.690.
                                             bodies applying for direct accreditation                                                                      continue to be treated as Schedule I
                                                                                                        (2) While a third-party certification
                                             must submit a fee concurrently with                                                                           controlled substances.
                                                                                                     body’s accreditation is suspended, the
                                             submitting an application or a renewal
                                                                                                     third-party certification body will not be            DATES: Effective: January 13, 2017.
                                             application.
                                                                                                     able to issue food or facility                        FOR FURTHER INFORMATION CONTACT:
                                               (b) Accreditation bodies and third-                   certifications. A food or facility
                                             party certification bodies subject to an                                                                      Michael J. Lewis, Office of Diversion
                                                                                                     certification issued by a third-party                 Control, Drug Enforcement
                                             annual fee must submit payment within                   certification body prior to the
                                             30 days of receiving billing for the fee.                                                                     Administration; Mailing Address: 8701
                                                                                                     suspension of the auditor/certification               Morrissette Drive, Springfield, Virginia
                                             § 1.720 Are user fees under this subpart                body accreditation will remain in effect.             22152; Telephone (202) 598–6812.
                                             refundable?                                                (3) If payment is not received within              SUPPLEMENTARY INFORMATION:
                                               User fees accompanying completed                      90 days of the payment due date, FDA
                                                                                                     will withdraw the third-party                         Background
                                             applications and annual fees under this
                                             subpart are not refundable.                             certification body’s accreditation under                 As provided in 21 CFR 1308.03, each
                                                                                                     § 1.664(a)(4), and provide notice of such             controlled substance or basic class
                                             § 1.725 What are the consequences of not                withdrawal in accordance with § 1.664.                thereof is assigned a four digit
                                             paying a user fee under this subpart on                                                                       Administration Controlled Substance
                                                                                                       Dated: December 9, 2016.
                                             time?
                                                                                                     Leslie Kux,                                           Code Number (‘‘Code number’’ or ‘‘drug
                                                (a) An application for recognition or                                                                      code’’) that is used to track quantities of
                                                                                                     Associate Commissioner for Policy.
                                             renewal of recognition will not be                                                                            the controlled substance imported and
                                                                                                     [FR Doc. 2016–30033 Filed 12–13–16; 8:45 am]
                                             considered complete for the purposes of                                                                       exported to and from the United States.
                                                                                                     BILLING CODE 4164–01–P
                                             § 1.631(a) until the date that FDA                                                                            Additionally, the DEA uses these code
                                             receives the application fee. An                                                                              numbers in establishing aggregate
                                             application for direct accreditation or                                                                       production quotas for basic classes of
                                             for renewal of direct accreditation will                DEPARTMENT OF JUSTICE                                 controlled substances listed in
                                             not be considered complete for the                                                                            Schedules I and II as required by 21
                                             purposes of § 1.671(a) until FDA                        Drug Enforcement Administration
                                                                                                                                                           U.S.C. 826.
                                             receives the application fee.                                                                                    Consistent with the Controlled
                                                (b) A recognized accreditation body                  21 CFR Part 1308
                                                                                                                                                           Substances Act (CSA), the schedules
                                             that fails to submit its annual user fee                [Docket No. DEA–342]                                  contained in DEA regulations include
                                             within 30 days of the due date will have                                                                      marihuana (drug code 7360) in
                                             its recognition suspended.                              RIN 1117–AB33                                         Schedule I. 21 CFR 1308.11(d)(23). This
                                                (1) FDA will notify the accreditation                                                                      listing includes (unless specifically
                                                                                                     Establishment of a New Drug Code for
                                             body electronically that its recognition                                                                      excepted or unless listed in another
                                                                                                     Marihuana Extract
                                             is suspended. FDA will notify the                                                                             schedule) any material, compound,
                                             public of the suspension on the Web site                AGENCY:  Drug Enforcement                             mixture, or preparation, which contains
                                             described in § 1.690.                                   Administration, Department of Justice.                any quantity of the substance, or which
                                                (2) While an accreditation body’s                    ACTION: Final rule.                                   contains any of its salts, isomers, and
                                             recognition is suspended, the                                                                                 salts of isomers that are possible within
                                             accreditation body will not be able to                  SUMMARY:   The Drug Enforcement                       the specific chemical designation.
rmajette on DSK2TPTVN1PROD with RULES




                                             accredit additional third-party                         Administration is creating a new                      Because the definition of marihuana in
                                             certification bodies. The accreditation of              Administration Controlled Substances                  21 U.S.C. 802(16) includes both
                                             third-party certification bodies that                   Code Number for ‘‘Marihuana Extract.’’                derivatives and preparations of
                                             occurred prior to an accreditation                      This code number will allow DEA and                   marihuana, the DEA until now has used
                                             body’s suspension, as well as food or                   DEA-registered entities to track                      drug code 7360 for extracts of
                                             facility certifications issued by such                  quantities of this material separately                marihuana. This final rule finalizes a


                                        VerDate Sep<11>2014   15:29 Dec 13, 2016   Jkt 241001   PO 00000   Frm 00010   Fmt 4700   Sfmt 4700   E:\FR\FM\14DER1.SGM   14DER1


                                                          Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Rules and Regulations                                           90195

                                             July 5, 2011, Notice of Proposed                        drugs. The placing of a drug into both                compounds and cannabidiol-type
                                             Rulemaking (76 FR 39039) in which the                   Schedule I and Schedule IV, therefore                 compounds, as well as
                                             DEA proposed that a new drug code                       imposes the most stringent controls                   cannabichromene-type compounds,
                                             7350 be used for extracts of marihuana.                 under the Single Convention. Although                 cannabigerol-type compounds, and
                                                                                                     cannabis and cannabis resin are listed in             other categories of compounds.
                                             Why a New Code Number Is Needed
                                                                                                     Schedules I and IV of the Single                         DEA response: DEA agrees with the
                                                The United Nations Conventions on                    Convention, cannabis extracts are listed              commenter that the term ‘‘cannabinoid’’
                                             international drug control treats extracts              only in Schedule I.                                   would provide for a broader definition
                                             from the cannabis plant somewhat                                                                              of marihuana extract; however, use of
                                             differently than marihuana or                           Comments
                                                                                                                                                           the term ‘‘cannabinoid’’ necessitates
                                             tetrahydrocannabinols. The creation of a                   In response to the July 5, 2011, Notice            that the DEA clarify that the new
                                             new drug code in the DEA regulations                    of Proposed Rulemaking (76 FR 39039),                 marihuana extract category (drug code
                                             for marihuana extracts will allow for                   the DEA received six submissions from                 7350) is not intended to include
                                             more appropriate accounting of such                     five commenters. Three of the                         ‘‘cannabis resin’’ as defined in the U.N.
                                             materials consistent with treaty                        comments raised issues relating to the                Single Convention.
                                             provisions.                                             medical use or legality of marihuana/                    As discussed in the NPRM, a new
                                                The Single Convention on Narcotic                    cannabis; these comments were not                     drug code is necessary in order to better
                                             Drugs, 1961 (‘‘Single Convention’’) and                 germane to the issues addressed by this               account for these materials in
                                             the 1971 Convention on Psychotropic                     rulemaking. A fourth comment was                      accordance with treaty obligations. The
                                             Substances (‘‘Psychotropic                              merely a clarification of a comment                   Single Convention placed ‘‘cannabis’’
                                             Convention’’) provide for the                           previously submitted.                                 and ‘‘cannabis resin’’ under both
                                             international control of marihuana                         One comment requested clarification                Schedule I and IV of the Convention,
                                             constituents. Many of the CSA’s                         of whether the new drug code will be                  the most stringent level of control under
                                             provisions were drafted to comply with                  applicable to cannabidiol (CBD), if it is             the Convention. While ‘‘cannabis resin’’
                                             these Conventions. The CSA includes                     not combined with cannabinols.                        is extracted from ‘‘cannabis,’’ the Single
                                             schemes of drug scheduling and                             DEA response: For practical purposes,
                                                                                                                                                           Convention specifically controls
                                             procedures for adding, removing, and                    all extracts that contain CBD will also
                                                                                                                                                           ‘‘extracts’’ separately. Extracts of
                                             transferring drugs among the schedules                  contain at least small amounts of other
                                                                                                                                                           cannabis are controlled only under
                                             that are similar, in some ways, to those                cannabinoids.1 However, if it were
                                                                                                     possible to produce from the cannabis                 Schedule I of the Convention, which is
                                             in the Single Convention. With respect
                                                                                                     plant an extract that contained only                  a lower level of control than ‘‘cannabis
                                             to those drugs that are subject to control
                                                                                                     CBD and no other cannabinoids, such                   resin.’’
                                             under the Single Convention, the CSA
                                                                                                     an extract would fall within the new                     Accordingly, it is the DEA’s intent to
                                             mandates that DEA control such drugs
                                                                                                     drug code 7350. In view of this                       define the term ‘‘marihuana extract’’ so
                                             in a manner that will ensure the United
                                                                                                     comment, the regulatory text                          as to exclude material referenced as
                                             States meets its obligations under the
                                                                                                     accompanying new drug code 7350 has                   ‘‘cannabis resin’’ under the Single
                                             Single Convention. 21 U.S.C. 811(d)(1).
                                                Somewhat similar to the CSA, the                     been modified slightly to make clear                  Convention on Narcotics. ‘‘Cannabis
                                             Single Convention lists substances in                   that it includes cannabis extracts that               resin’’ (regulated under the CSA as a
                                             four schedules. However, under the                      contain only one cannabinoid.                         resin of marihuana) contains a variety of
                                             Single Convention, the drugs that are                      Another comment from a                             ‘‘cannabinoids’’ and will continue to be
                                             subject to the most stringent controls are              pharmaceutical firm currently involved                regulated as marihuana under drug code
                                             in Schedule IV. Another difference                      in cannabinoid research and product                   7360. The new drug code for marihuana
                                             between the CSA and the Single                          development praised DEA’s efforts to                  extracts under 21 CFR 1308.11(d)(58)
                                             Convention is that, under the latter, a                 establish a new drug code for marihuana               will exclude the resin. Cannabis resin
                                             drug can be listed in more than one                     extracts as a means to more accurately                and marihuana resin remain captured
                                             schedule. Cannabis and cannabis resin                   reflect the activities of scientific                  under the drug code for marihuana
                                             are listed in both Schedule IV and                      research and provide more consistent                  (drug code 7360), thus differentiating
                                             Schedule I of the Single Convention.                    adherence to the requirements of the                  this material from marihuana extracts
                                             Schedule I controls under the Single                    Single Convention. However, the                       (new drug code 7350). This will
                                             Convention include: Requirements for                    comment expressed concerns that the                   maintain compliance with the Single
                                             import and export authorization,                        proposed definition for the new drug                  Convention.
                                             licensing of manufacturers/distributors,                code (i.e. ‘‘meaning extracts that have               Final Action
                                             recordkeeping requirements, a                           been derived from any plant of the
                                             requirement for prescriptions for                       genus Cannabis and which contain                        After careful consideration of all
                                             medical use, annual estimate of needs,                  cannabinols and cannabidiols’’) is too                comments, the DEA is hereby amending
                                             quotas, annual statistical reporting, and               narrow. The comment suggested that the                21 CFR 1308.11(d) to include a new
                                             a requirement that use be limited to                    broader term ‘‘cannabinoids’’ be                      subparagraph (58) which creates a new
                                             medical and scientific purposes.                        substituted for ‘‘cannabinols and                     code number in Schedule I as follows:
                                             Schedule II of the Single Convention is                 cannabidiols.’’ The comment pointed                   ‘‘(58) Marihuana Extract—7350
                                             similar in controls to Schedule I with a                out that other constituents of the                       ‘‘Meaning an extract containing one or
                                             few exceptions, and Schedule III is less                marihuana plant may have therapeutic                  more cannabinoids that has been derived
                                             restrictive. All substances listed in                   potential. The comment further clarified              from any plant of the genus Cannabis, other
                                             Schedule IV are also listed in Schedule                 that the broader term ‘‘cannabinoid’’                 than the separated resin (whether crude or
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                                             I under the Single Convention in order                  includes both cannabinol-type                         purified) obtained from the plant.’’
                                             to encompass the requirements                                                                                   The creation of this new drug code in
                                                                                                       1 Although it might be theoretically possible to
                                             mentioned above. In addition, as                                                                              the DEA regulations for marihuana
                                                                                                     produce a CBD extract that contains absolutely no
                                             indicated, the Single Convention                        amounts of other cannabinoids, the DEA is not
                                                                                                                                                           extracts allows for more appropriate
                                             imposes certain heightened measures of                  aware of any industrially-utilized methods that       accounting of such materials consistent
                                             control with respect to Schedule IV                     have achieved this result.                            with treaty provisions. Such marihuana


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                                             90196        Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Rules and Regulations

                                             extracts remain in Schedule I. Entities                 extracts but within another already-                  List of Subjects in 21 CFR Part 1308
                                             registered to handle marihuana (under                   established drug code. Thus, persons                    Drug traffic control, Controlled
                                             drug code 7360) that also handle                        who handle these marihuana extracts                   substances.
                                             marihuana extracts, will need to apply                  have already met DEA’s registration,
                                             to modify their registrations to add the                security, and other statutory and                       For the reasons set out above, 21 CFR
                                             new drug code 7350 to their existing                    regulatory requirements. The only direct              part 1308 is amended as follows:
                                             DEA registrations and procure quotas                    effect to registrants who handle                      PART 1308—SCHEDULES OF
                                             specifically for drug code 7350 each                    marihuana extracts will be the                        CONTROLLED SUBSTANCES
                                             year.                                                   requirement to add the new drug code
                                             Regulatory Analyses                                     to their registration. Therefore, DEA has             ■ 1. The authority citation for part 1308
                                                                                                     concluded that this rule will not have a              continues to read as follows:
                                             Executive Orders 12866 and 13563,                       significant effect on a substantial
                                             Regulatory Planning and Review, and                                                                             Authority: 21 U.S.C. 811, 812, 871(b),
                                                                                                     number of small entities.                             unless otherwise noted.
                                             13563, Improving Regulation and
                                             Regulatory Review                                       Unfunded Mandates Reform Act of 1995                  ■ 2. Section 1308.11 is amended by
                                               This regulation has been drafted and                    On the basis of information contained               adding paragraph (d)(58) to read as
                                             reviewed in accordance with the                         in the ‘‘Regulatory Flexibility Act’’                 follows:
                                             principles of Executive Orders 12866                    section above, DEA has determined and                 § 1308.11   Schedule I.
                                             and 13563. This rule is not a significant               certifies pursuant to the Unfunded
                                                                                                                                                           *      *    *    *    *
                                             regulatory action under Executive Order                 Mandates Reform Act (UMRA) of 1995,
                                                                                                                                                              (d) * * *
                                             12866.                                                  2 U.S.C. 1501 et seq., that this action
                                                                                                     would not result in any Federal                       (58) Marihuana Extract—(7350)
                                             Executive Order 12988, Civil Justice                                                                             Meaning an extract containing one or
                                                                                                     mandate that may result in the
                                             Reform                                                                                                        more cannabinoids that has been
                                                                                                     expenditure by State, local, and tribal
                                                This regulation meets the applicable                 governments, in the aggregate, or by the              derived from any plant of the genus
                                             standards set forth in sections 3(a) and                private sector, of $100,000,000 or more               Cannabis, other than the separated resin
                                             3(b)(2) of Executive Order 12988 to                     (adjusted for inflation) in any one year.             (whether crude or purified) obtained
                                             eliminate drafting errors and ambiguity,                Therefore, neither a Small Government                 from the plant.
                                             minimize litigation, provide a clear legal              Agency Plan nor any other action is                   *      *    *    *    *
                                             standard for affected conduct, and                      required under provisions of the UMRA
                                             promote simplification and burden                                                                               Dated: December 7, 2016.
                                                                                                     of 1995.
                                             reduction.                                                                                                    Chuck Rosenberg,
                                                                                                     Paperwork Reduction Act of 1995                       Acting Administrator.
                                             Executive Order 13132, Federalism
                                                                                                       This action does not impose a                       [FR Doc. 2016–29941 Filed 12–13–16; 8:45 am]
                                               This rulemaking does not have
                                                                                                     collection of information requirement                 BILLING CODE 4410–09–P
                                             federalism implications warranting the
                                                                                                     under the Paperwork Reduction Act of
                                             application of Executive Order 13132.
                                                                                                     1995. 44 U.S.C. 3501–3521. This action
                                             The rule does not have substantial                                                                            DEPARTMENT OF LABOR
                                                                                                     would not impose recordkeeping or
                                             direct effects on the States, on the
                                                                                                     reporting requirements on State or local
                                             relationship between the national                                                                             Occupational Safety and Health
                                                                                                     governments, individuals, businesses, or
                                             government and the States, or the                                                                             Administration
                                                                                                     organizations. An agency may not
                                             distribution of power and
                                                                                                     conduct or sponsor, and a person is not
                                             responsibilities among the various                                                                            29 CFR Part 1988
                                                                                                     required to respond to, a collection of
                                             levels of government.
                                                                                                     information unless it displays a                      [Docket Number: OSHA–2015–0021]
                                             Executive Order 13175, Consultation                     currently valid OMB control number.
                                             and Coordination With Indian Tribal                                                                           RIN 1218–AC88
                                             Governments                                             Congressional Review Act
                                                                                                                                                           Procedures for Handling Retaliation
                                               This rule does not have tribal                          This rule is not a major rule as
                                                                                                                                                           Complaints Under Section 31307 of the
                                             implications warranting the application                 defined by section 804 of the Small
                                                                                                                                                           Moving Ahead for Progress in the 21st
                                             of Executive Order 13175. It does not                   Business Regulatory Enforcement
                                                                                                                                                           Century Act (MAP–21)
                                             have substantial direct effects on one or               Fairness Act of 1996 (Congressional
                                             more Indian tribes, on the relationship                 Review Act (CRA)). This rule will not                 AGENCY:  Occupational Safety and Health
                                             between the Federal Government and                      result in: An annual effect on the                    Administration, Labor.
                                             Indian tribes, or on the distribution of                economy of $100,000,000 or more; a                    ACTION: Final rule.
                                             power and responsibilities between the                  major increase in costs or prices for
                                             Federal Government and Indian tribes.                   consumers, individual industries,                     SUMMARY:   On March 16, 2016, the
                                                                                                     Federal, State, or local government                   Occupational Safety and Health
                                             Regulatory Flexibility Act                              agencies, or geographic regions; or                   Administration (OSHA) of the U.S.
                                               The Administrator, in accordance                      significant adverse effects on                        Department of Labor (Department)
                                             with the Regulatory Flexibility Act                     competition, employment, investment,                  issued an interim final rule (IFR) that
                                             (RFA), 5 U.S.C. 601–602, has reviewed                   productivity, innovation, or on the                   provided procedures for the
                                             this rule and by approving it, certifies                ability of U.S.-based companies to                    Department’s processing of complaints
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                                             that it will not have a significant                     compete with foreign based companies                  under the employee protection
                                             economic impact on a substantial                        in domestic and export markets.                       (retaliation or whistleblower) provisions
                                             number of small entities. This rule                     However, pursuant to the CRA, the DEA                 of Section 31307 of the Moving Ahead
                                             establishes a new drug code for                         has submitted a copy of this final rule               for Progress in the 21st Century Act
                                             marihuana extracts. DEA already                         to both Houses of Congress and to the                 (MAP–21). The IFR established
                                             registers persons handling marihuana                    Comptroller General.                                  procedures and time frames for the


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Document Created: 2016-12-14 00:48:20
Document Modified: 2016-12-14 00:48:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesEffective: January 13, 2017.
ContactMichael J. Lewis, Office of Diversion
FR Citation81 FR 90194 
RIN Number1117-AB33
CFR AssociatedDrug Traffic Control and Controlled Substances

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