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CRC Petition DEA Answer

CRC Petition DEA Answer

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Drug Enforcement Administration: Denial of Petition To Initiate Proceedings To Reschedule Marijuana;
Proposed Rule
Drug Enforcement Administration: Denial of Petition To Initiate Proceedings To Reschedule Marijuana;
Proposed Rule

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Vol. 76 Friday,No. 131 July 8, 2011Part IV
Department of Justice
Drug Enforcement Administration21 CFR Chapter IIDenial of Petition To Initiate Proceedings To Reschedule Marijuana;Proposed Rule
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40552
Federal Register
/Vol. 76, No. 131/Friday, July 8, 2011/Proposed Rules
1
Note that ‘‘marihuana’’ is the spelling originallyused in the Controlled Substances Act (CSA). Thisdocument uses the spelling that is more commonin current usage, ‘‘marijuana.’’
DEPARTMENT OF JUSTICEDrug Enforcement Administration21 CFR Chapter II
[Docket No. DEA–352N]
Denial of Petition To InitiateProceedings To Reschedule Marijuana
AGENCY
:
Drug EnforcementAdministration (DEA), Department of  Justice.
ACTION
:
Denial of petition to initiateproceedings to reschedule marijuana.
SUMMARY
:
By letter dated June 21, 2011,the Drug Enforcement Administration(DEA) denied a petition to initiaterulemaking proceedings to reschedulemarijuana.
1
Because DEA believes thatthis matter is of particular interest tomembers of the public, the agency ispublishing below the letter sent to thepetitioner (denying the petition), alongwith the supporting documentation thatwas attached to the letter.
FOR FURTHER INFORMATION CONTACT
:
Imelda L. Paredes, Office of DiversionControl, Drug EnforcementAdministration, 8701 Morrissette Drive,Springfield, Virginia 22152; Telephone(202) 307–7165.
SUPPLEMENTARY INFORMATION
:
June 21, 2011.
Dear Mr. Kennedy:On October 9, 2002, you petitionedthe Drug Enforcement Administration(DEA) to initiate rulemakingproceedings under the reschedulingprovisions of the Controlled SubstancesAct (CSA). Specifically, you petitionedDEA to have marijuana removed fromschedule I of the CSA and rescheduledas cannabis in schedule III, IV or V.You requested that DEA removemarijuana from schedule I based onyour assertion that:(1) Cannabis has an accepted medicaluse in the United States;(2) Cannabis is safe for use undermedical supervision;(3) Cannabis has an abuse potentiallower than schedule I or II drugs; and(4) Cannabis has a dependenceliability that is lower than schedule I orII drugs.In accordance with the CSArescheduling provisions, after gatheringthe necessary data, DEA requested ascientific and medical evaluation andscheduling recommendation from theDepartment of Health and HumanServices (DHHS). DHHS concluded thatmarijuana has a high potential for abuse,has no accepted medical use in theUnited States, and lacks an acceptablelevel of safety for use even undermedical supervision. Therefore, DHHSrecommended that marijuana remain inschedule I. The scientific and medicalevaluation and schedulingrecommendation that DHHS submittedto DEA is attached hereto.Based on the DHHS evaluation and allother relevant data, DEA has concludedthat there is no substantial evidence thatmarijuana should be removed fromschedule I. A document prepared byDEA addressing these materials in detailalso is attached hereto. In short,marijuana continues to meet the criteriafor schedule I control under the CSA because:(1)
Marijuana has a high potential for abuse.
The DHHS evaluation and theadditional data gathered by DEA showthat marijuana has a high potential forabuse.(2)
Marijuana has no currently accepted medical use in treatment inthe United States.
According toestablished case law, marijuana has no‘‘currently accepted medical use’’ because: The drug’s chemistry is notknown and reproducible; there are noadequate safety studies; there are noadequate and well-controlled studiesproving efficacy; the drug is notaccepted by qualified experts; and thescientific evidence is not widelyavailable.(3)
Marijuana lacks accepted safety  for use under medical supervision.
Atpresent, there are no U.S. Food andDrug Administration (FDA)-approvedmarijuana products, nor is marijuanaunder a New Drug Application (NDA)evaluation at the FDA for anyindication. Marijuana does not have acurrently accepted medical use intreatment in the United States or acurrently accepted medical use withsevere restrictions. At this time, theknown risks of marijuana use have not been shown to be outweighed byspecific benefits in well-controlledclinical trials that scientifically evaluatesafety and efficacy.You also argued that cannabis has adependence liability that is lower thanschedule I or II drugs. Findings as to thephysical or psychological dependenceof a drug are only one of eight factorsto be considered. As discussed furtherin the attached documents, DHHS statesthat long-term, regular use of marijuanacan lead to physical dependence andwithdrawal following discontinuationas well as psychic addiction ordependence.The statutory mandate of 21 U.S.C.812(b) is dispositive. Congressestablished only one schedule, scheduleI, for drugs of abuse with ‘‘no currentlyaccepted medical use in treatment in theUnited States’’ and ‘‘lack of acceptedsafety for use under medicalsupervision.’’ 21 U.S.C. 812(b).Accordingly, and as set forth in detailin the accompanying DHHS and DEAdocuments, there is no statutory basisunder the CSA for DEA to grant yourpetition to initiate rulemakingproceedings to reschedule marijuana.Your petition is, therefore, herebydenied.Sincerely,
Michele M. Leonhart,
Administrator.
Attachments:Marijuana. Scheduling Review Document:Eight Factor AnalysisBasis for the recommendation formaintaining marijuana in schedule I of theControlled Substances ActDate: June 30, 2011Michele M. Leonhart
Administrator 
Department of Health and Human Services,
Office of the Secretary Assistant Secretary forHealth, Office of Public Health and ScienceWashington, D.C. 20201.December 6, 2006.The Honorable Karen P. Tandy
Administrator, Drug Enforcement Administration, U.S. Department of  Justice, Washington, D.C. 20537 
Dear Ms. Tandy:This is in response to your request of July2004, and pursuant to the ControlledSubstances Act (CSA), 21 U.S.C. 811(b), (c),and (f), the Department of Health and HumanServices (DHHS) recommends that marijuanacontinue to be subject to control underSchedule I of the CSA.Marijuana is currently controlled underSchedule I of the CSA. Marijuana continuesto meet the three criteria for placing asubstance in Schedule I of the CSA under 21U.S.C. 812(b)(l). As discussed in the attachedanalysis, marijuana has a high potential forabuse, has no currently accepted medical usein treatment in the United States, and has alack of an accepted level of safety for useunder medical supervision. Accordingly,HHS recommends that marijuana continue to be subject to control under Schedule I of theCSA. Enclosed is a document prepared byFDA’s Controlled Substance Staff that is the basis for this recommendation.Should you have any questions regardingthis recommendation, please contact CorinneP. Moody, of the Controlled Substance Staff,Center for Drug Evaluation and Research. Ms.Moody can be reached at 301–827–1999.Sincerely yours, John O. Agwunobi,
Assistant Secretary for Health.
Enclosure:
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40553
Federal Register
/Vol. 76, No. 131/Friday, July 8, 2011/Proposed Rules
2
The CSA defines marijuana as the following:all parts of the plant Cannabis Sativa L., whethergrowing or not; the seeds thereof; the resinextracted from any part of such plant; and everycompound, manufacture, salt, derivative, mixture,or preparation of such plant, its seeds or resin. Suchterm does not include the mature stalks of suchplant, fiber produced from such stalks, oil or cakemade from the seeds of such plant, any othercompound, manufacture, salt, derivative, mixture,or preparation of such mature stalks (except theresin extracted there from), fiber, oil, or cake, or thesterilized seed of such plant which is incapable of germination (21 U.S.C. 802(16)).
Basis for the Recommendation forMaintaining Marijuana in Schedule I of theControlled Substances Act
BASIS FOR THE RECOMMENDATION FORMAINTAINING MARIJUANA INSCHEDULE I OF THE CONTROLLEDSUBSTANCES ACT
On October 9, 2002, the Coalition forRescheduling Cannabis (hereafter known asthe Coalition) submitted a petition to theDrug Enforcement Administration (DEA)requesting that proceedings be initiated torepeal the rules and regulations that placemarijuana in Schedule I of the ControlledSubstances Act (CSA). The petition contendsthat cannabis has an accepted medical use inthe United States, is safe for use undermedical supervision, and has an abusepotential and a dependency liability that islower than Schedule I or II drugs. Thepetition requests that marijuana berescheduled as ‘‘cannabis’’ in either ScheduleIII, IV, or V of the CSA. In July 2004, the DEAAdministrator requested that the Departmentof Health and Human Services (HHS) providea scientific and medical evaluation of theavailable information and a schedulingrecommendation for marijuana, inaccordance with the provisions of 21 U.S.C.811(b).In accordance with 21 U.S.C. 811(b), DEAhas gathered information related to thecontrol of marijuana (
Cannabis sativa
)
2
 under the CSA. Pursuant to 21 U.S.C. 811(b),the Secretary is required to consider in ascientific and medical evaluation eightfactors determinative of control under theCSA. Following consideration of the eightfactors, if it is appropriate, the Secretary mustmake three findings to recommendscheduling a substance in the CSA. Thefindings relate to a substance’s abusepotential, legitimate medical use, and safetyor dependence liability.Administrative responsibilities forevaluating a substance for control under theCSA are performed by the Food and DrugAdministration (FDA), with the concurrenceof the National Institute on Drug Abuse(NIDA), as described in the Memorandum of Understanding (MOU) of March 8, 1985 (50FR 9518–20).In this document, FDA recommends thecontinued control of marijuana in ScheduleI of the CSA. Pursuant to 21 U.S.C. 811(c),the eight factors pertaining to the schedulingof marijuana are considered below.
1. ITS ACTUAL OR RELATIVE POTENTIALFOR ABUSE
The first factor the Secretary must consideris marijuana’s actual or relative potential forabuse. The term ‘‘abuse’’ is not defined in theCSA. However, the legislative history of theCSA suggests the following in determiningwhether a particular drug or substance has apotential for abuse:a. Individuals are taking the substance inamounts sufficient to create a hazard to theirhealth or to the safety of other individuals orto the community. b. There is a significant diversion of thedrug or substance from legitimate drugchannels.c. Individuals are taking the substance ontheir own initiative rather than on the basisof medical advice from a practitionerlicensed by law to administer suchsubstances.d. The substance is so related in its actionto a substance already listed as having apotential for abuse to make it likely that itwill have the same potential for abuse assuch substance, thus making it reasonable toassume that there may be significantdiversions from legitimate channels,significant use contrary to or without medicaladvice, or that it has a substantial capabilityof creating hazards to the health of the useror to the safety of the community.Comprehensive Drug Abuse Prevention andControl Act of 1970, H.R. Rep. No. 91–1444, 91st Cong., Sess. 1 (1970) reprintedin U.S.C.C.A.N. 4566, 4603.In considering these concepts in a varietyof scheduling analyses over the last threedecades, the Secretary has analyzed a rangeof factors when assessing the abuse liabilityof a substance. These factors have includedthe prevalence and frequency of use in thegeneral public and in specific sub-populations, the amount of the material thatis available for illicit use, the ease withwhich the substance may be obtained ormanufactured, the reputation or status of thesubstance ‘‘on the street,’’ as well as evidencerelevant to population groups that may be atparticular risk.Abuse liability is a complex determinationwith many dimensions. There is no singletest or assessment procedure that, by itself,provides a full and completecharacterization. Thus, no single measure of abuse liability is ideal. Scientifically, acomprehensive evaluation of the relativeabuse potential of a drug substance caninclude consideration of the drug’s receptor binding affinity, preclinical pharmacology,reinforcing effects, discriminative stimuluseffects, dependence producing potential,pharmacokinetics and route of administration, toxicity, assessment of theclinical efficacy-safety database relative toactual abuse, clinical abuse liability studies,and the public health risks followingintroduction of the substance to the generalpopulation. It is important to note that abusemay exist independent of a state of toleranceor physical dependence, because drugs may be abused in doses or in patterns that do notinduce these phenomena. Animal data,human data, and epidemiological data are allused in determining a substance’s abuseliability. Epidemiological data can also be animportant indicator of actual abuse. Finally,evidence of clandestine production and illicittrafficking of a substance are also importantfactors.
a. There is evidence that individuals aretaking the substance in amounts sufficient tocreate a hazard to their health or to thesafety of other individuals or to thecommunity.
Marijuana is a widely abused substance.The pharmacology of the psychoactiveconstituents of marijuana, including delta
9
-tetrahydrocannabinol (delta
9
-THC), theprimary psychoactive ingredient inmarijuana, has been studied extensively inanimals and humans and is discussed inmore detail below in Factor 2, ‘‘ScientificEvidence of its Pharmacological Effects, if Known.’’ Data on the extent of marijuanaabuse are available from HHS through NIDAand the Substance Abuse and Mental HealthServices Administration (SAMHSA). Thesedata are discussed in detail under Factor 4,‘‘Its History and Current Pattern of Abuse;’’Factor 5, ‘‘The Scope, Duration, andSignificance of Abuse;’’ and Factor 6, ‘‘What,if any, Risk There is to the Public Health?’’According to SAMHSA’s 2004 NationalSurvey on Drug Use and Health (NSDUH; thedatabase formerly known as the NationalHousehold Survey on Drug Abuse (NHSDA)),the latest year for which complete data areavailable, 14.6 million Americans have usedmarijuana in the past month. This is anincrease of 3.4 million individuals since1999, when 11.2 million individuals reportedusing marijuana monthly. (See the discussionof NSDUH data under Factor 4).The Drug Abuse Warning Network(DAWN), sponsored by SAMHSA, is anational probability survey of U.S. hospitalswith emergency departments (EDs) designedto obtain information on ED visits in whichrecent drug use is implicated; 2003 is thelatest year for which complete data areavailable. Marijuana was involved in 79,663ED visits (13 percent of drug-related visits).There are a number of risks resulting from both acute and chronic use of marijuanawhich are discussed in full below underFactors 2 and 6.
 b. There is significant diversion of thesubstance from legitimate drug channels.
At present, cannabis is legally availablethrough legitimate channels for researchpurposes only and thus has a limitedpotential for diversion. In addition, the lackof significant diversion of investigationalsupplies may result from the readyavailability of illicit cannabis of equal orgreater quality. The magnitude of the demandfor illicit marijuana is evidenced by DEA/Office of National Drug Control Policy(ONDCP) seizure statistics. Data on marijuanaseizures can often highlight trends in theoverall trafficking patterns. DEA’s Federal-Wide Drug Seizure System (FDSS) providesinformation on total federal drug seizures.FDSS reports total federal seizures of 2,700,282 pounds of marijuana in 2003, thelatest year for which complete data areavailable (DEA, 2003). This represents nearlya doubling of marijuana seizures since 1995,when 1,381,107 pounds of marijuana wereseized by federal agents.
c. Individuals are taking the substance ontheir own initiative rather than on the basisof medical advice from a practitionerlicensed by law to administer suchsubstances.
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