/Vol. 76, No. 131/Friday, July 8, 2011/Proposed Rules
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 (
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
-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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