Federal Register/Vol. 81, No. 156/Friday, August 12, 2016
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53688 Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Proposed Rules DEPARTMENT OF JUSTICE recommendation that the HHS submitted to Preliminary Note Regarding Treaty the DEA is enclosed with this letter. Considerations Drug Enforcement Administration Based on the HHS evaluation and all other Cover Letter from HHS to DEA relevant data, the DEA has concluded that Summarizing the Scientific and Medical 21 CFR Chapter II there is no substantial evidence that Evaluation and Scheduling Recommendation marijuana should be removed from Schedule for Marijuana. [Docket No. DEA–426] I. A document prepared by the DEA U.S. Department of Health and Human addressing these materials in detail also is Services (HHS)—Basis for the Denial of Petition To Initiate enclosed. In short, marijuana continues to Recommendation for Maintaining Marijuana Proceedings To Reschedule Marijuana meet the criteria for Schedule I control under in Schedule I of the Controlled Substances the CSA because: Act AGENCY: Drug Enforcement (1) Marijuana has a high potential for U.S. Department of Justice—Drug Administration, Department of Justice. abuse. The HHS evaluation and the Enforcement Administration (DEA), ACTION: Denial of petition to initiate additional data gathered by the DEA show Schedule of Controlled Substances: Maintaining Marijuana in Schedule I of the proceedings to reschedule marijuana. that marijuana has a high potential for abuse. Controlled Substances Act, Background, (2) Marijuana has no currently accepted Data, and Analysis: Eight Factors SUMMARY: By letter dated July 19, 2016 medical use in treatment in the United Determinative of Control and Findings the Drug Enforcement Administration States. Based on the established five-part test Pursuant to 21 U.S.C. 812(b) (DEA) denied a petition to initiate for making such determination, marijuana rulemaking proceedings to reschedule has no ‘‘currently accepted medical use’’ Dated: July 19, 2016. marijuana. Because the DEA believes because: As detailed in the HHS evaluation, Chuck Rosenberg, that this matter is of particular interest the drug’s chemistry is not known and Acting Administrator, Preliminary Note to members of the public, the agency is reproducible; there are no adequate safety Regarding Treaty Considerations. publishing below the letter sent to the studies; there are no adequate and well- As the Controlled Substances Act petitioner which denied the petition, controlled studies proving efficacy; the drug (CSA) recognizes, the United States is a along with the supporting is not accepted by qualified experts; and the party to the Single Convention on documentation that was attached to the scientific evidence is not widely available. Narcotic Drugs, 1961 (referred to here as (3) Marijuana lacks accepted safety for use the Single Convention or the treaty). 21 letter. under medical supervision. At present, there DATES: August 12, 2016. are no marijuana products approved by the U.S.C. 801(7). Parties to the Single FOR FURTHER INFORMATION CONTACT: U.S. Food and Drug Administration (FDA), Convention are obligated to maintain Michael J. Lewis, Office of Diversion nor is marijuana under a New Drug various control provisions related to the Control, Drug Enforcement Application (NDA) evaluation at the FDA for drugs that are covered by the treaty. Administration; Mailing Address: 8701 any indication. The HHS evaluation states Many of the provisions of the CSA were Morrissette Drive, Springfield, Virginia that marijuana does not have a currently enacted by Congress for the specific 22152; Telephone: (202) 598–6812. accepted medical use in treatment in the purpose of ensuring U.S. compliance United States or a currently accepted medical with the treaty. Among these is a SUPPLEMENTARY INFORMATION: use with severe restrictions. At this time, the scheduling provision, 21 U.S.C. July 19, 2016 known risks of marijuana use have not been 811(d)(1). Section 811(d)(1) provides Dear Ms. Raimondo and Mr. Inslee: shown to be outweighed by specific benefits that, where a drug is subject to control On November 30, 2011, your predecessors, in well-controlled clinical trials that under the Single Convention, the DEA The Honorable Lincoln D. Chafee and The scientifically evaluate safety and efficacy. Administrator (by delegation from the Honorable Christine O. Gregoire, petitioned The statutory mandate of Title 21 United the Drug Enforcement Administration (DEA) Attorney General) must ‘‘issue an order States Code, Section 812(b) (21 U.S.C. 812(b)) controlling such drug under the to initiate rulemaking proceedings under the is dispositive. Congress established only one rescheduling provisions of the Controlled schedule, Schedule I, for drugs of abuse with schedule he deems most appropriate to Substances Act (CSA). Specifically, your ‘‘no currently accepted medical use in carry out such [treaty] obligations, predecessors petitioned the DEA to have treatment in the United States’’ and ‘‘lack of without regard to the findings required marijuana and ‘‘related items’’ removed from accepted safety for use . under medical by [21 U.S.C. 811(a) or 812(b)] and Schedule I of the CSA and rescheduled as supervision.’’ 21 U.S.C. 812(b). without regard to the procedures medical cannabis in Schedule II. Although the HHS evaluation and all other prescribed by [21 U.S.C. 811(a) and Your predecessors requested that the DEA relevant data lead to the conclusion that (b)].’’ remove marijuana and related items from marijuana must remain in schedule I, it Marijuana is a drug listed in the Schedule I based on their assertion that: (1) Cannabis has accepted medical use in should also be noted that, in view of United Single Convention. The Single the United States; States obligations under international drug Convention uses the term ‘‘cannabis’’ to (2) Cannabis is safe for use under medical control treaties, marijuana cannot be placed refer to marijuana.1 Thus, the DEA supervision; in a schedule less restrictive than schedule (3) Cannabis for medical purposes has a II. This is explained in detail in 1 Under the Single Convention, ‘‘cannabis plant’ relatively low potential for abuse, especially accompanying document titled ‘‘Preliminary means any plant of the genus Cannabis.’’ Article in comparison with other Schedule II drugs. Note Regarding Treaty Considerations.’’ 1(c). The Single Convention defines ‘‘cannabis’’ to In accordance with the CSA rescheduling Accordingly, and as set forth in detail in include ‘‘the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves provisions, after gathering the necessary data, the accompanying HHS and DEA documents, when not accompanied by the tops) from which the the DEA requested a scientific and medical there is no statutory basis under the CSA for resin has not been extracted, by whatever name evaluation and scheduling recommendation the DEA to grant your predecessors’ petition they may be designated.’’ Article 1(b). This from the Department of Health and Human to initiate rulemaking proceedings to definition of ‘‘cannabis’’ under the Single Services (HHS). The HHS concluded that reschedule marijuana. The petition is, Convention is slightly less inclusive than the CSA marijuana has a high potential for abuse, has therefore, hereby denied. definition of ‘‘marihuana,’’ which includes all parts no accepted medical use in the United States, of the cannabis plant except for the mature stalks, and lacks an acceptable level of safety for use sterilized seeds, oil from the seeds, and certain Sincerely, derivatives thereof. See 21 U.S.C. 802(16). Cannabis even under medical supervision. Therefore, Chuck Rosenberg, and cannabis resin are included in the list of drugs the HHS recommended that marijuana in Schedule I and Schedule IV of the Single remain in Schedule I. The scientific and Acting Administrator. Convention. In contrast to the CSA, the drugs listed medical evaluation and scheduling Attachments: in Schedule IV of the Single Convention are also VerDate Sep<11>2014 20:51 Aug 11, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\12AUP2.SGM 12AUP2 mstockstill on DSK3G9T082PROD with PROPOSALS2 Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Proposed Rules 53689 Administrator is obligated under section petition and keep marijuana in schedule Marijuana meets the three criteria for 811(d) to control marijuana in the I. placing a substance in Schedule I of the CSA schedule that he deems most As indicated, where section 811(d)(1) under 21 U.S.C. 812(b)(1). As discussed in appropriate to carry out the U.S. applies to a drug that is the subject of the enclosed analyses, marijuana has a high a rescheduling petition, the DEA potential for abuse, no currently accepted obligations under the Single medical use in treatment in the United Convention. It has been established in Administrator must issue an order States, and a lack of accepted safety for use prior marijuana rescheduling controlling the drug under the schedule under medical supervision. Accordingly, proceedings that placement of he deems most appropriate to carry out HHS recommends that marijuana be marijuana in either schedule I or United States obligations under the maintained in Schedule I of the CSA. schedule II of the CSA is ‘‘necessary as Single Convention, without regard to Enclosed are two documents prepared by well as sufficient to satisfy our the findings required by sections 811(a) FDA’s Controlled Substance Staff (in international obligations’’ under the or 812(b) and without regard