2011-16800. 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 [phone].

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 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 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:

§ 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.