Applications, hearings, determinations, etc.: Church of the Living Tree,

[Federal Register: April 9, 2003 (Volume 68, Number 68)]

[Notices]

[Page 17403-17405]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr09ap03-83]

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 01-1]

The Church of the Living Tree; Denial of Application

On November 4, 1999, and pursuant to 21 U.S.C. 823(a), the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to the Church of the Living Tree (Respondent) of Leggett, California, proposing to deny its application for DEA Certificate of Registration as a manufacturer of marijuana, a Schedule I controlled substance. The Order to Show Cause alleged that the pending application should be denied because the Respondent's proposed manufacture and distribution of marijuana for human consumption was a purpose not in conformity with the provisions of the Controlled Substances Act, under 21 U.S.C., section 2 812(b)(1), 822(b), 823(f)(4), and 841(a)(1).

By letter dated November 26, 1999, the Respondent, through its trustee John Stahl (Mr. Stahl), timely filed a request for a hearing on the issues raised by the Order to Show Cause, stating, in part, that Respondent sought ``* * * to cultivate cannabis sativa for purposes which are allowable under California Law, and to process the remaining stalk into pulp for our paper mill.'' Through inadvertence, this request was not docketed for a possible hearing. As a result, the then- Deputy Administrator of the DEA issued a final order finding that Respondent had not responded to the Order to Show Cause and denying

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Respondent's application. 65 FR 50,567 (August 3, 2000). However, by error, and the agency subsequently rescinded the prior final order by order dated November 21, 2000. 65 FR 75958 (2000). The matter was then docketed before Administrative Law Judge Mary Ellen Bittner (Judge Bittner).

On October 23, 2000, the Government filed a Motion for Summary Disposition, reiterating the allegations contained in the Order to Show Cause and further alleging, in part, that the manufacture of marijuana for human consumption is a purpose not in conformity with the Controlled Substance Act. The Government further argued that DEA rejected a previous petition to reschedule marijuana when it found that the drug has no currently accepted medical use. Marijuana Scheduling Petition; Denial of Petition; Remand, 59 FR 10,499, 10,507 (1992). The Government added that because the Respondent's previous DEA application for registration as a marijuana manufacturer was denied, the Respondent is now precluded from re-litigating the matter in its renewed effort to obtain a similar registration under the doctrine of res judicata. Robert A. Leslie, M.D., 64 FR 25,908 (1999); Robert M. Golden, M.D., 63 FR 38,669 (1998).

On November 1, and December 1, 2000, the Respondent filed its Response to Motion for Summary Disposition and Further Response to Motion for Summary Disposition respectively. In its submissions, the Respondent argued in essence that it ``* * * intended to cultivate medical marijuana as a cooperative farm of * * * patients qualifying under the terms of the Compassionate Use Act of 1996 (the Compassionate Use Act).'' As noted in a previous DEA final order, effective November 6, 1996, voters in California adopted the Compassionate Use Act, which provides that persons may grow or posses marijuana ``upon the written or oral recommendation or approval of a physician.'' Cal. Health & Safety Code section 11362.5 Marion ``Molly'' Fry, M.D., 67 FR 78015, 78017 (2002). The Respondent further argued in relevant part that California's marijuana law should be given deference by the Federal Government, and the Government's motion for summary disposition rejected, since there remained a fundamental question for resolution by the instant proceedings: whether Respondent's application should denied despite its engaging in activities that are now sanctioned under California state law (i.e., cultivation of marijuana for human consumption).

On April 17, 2001, Judge Bittner issued her Opinion and Recommended Decision, granting the Government's Motion for Summary Disposition and recommending that Respondent's application for DEA registration be denied. Neither party filed exceptions to Judge Bittner's recommended ruling, and on June 12, 2001, the record was transmitted to the Deputy Administrator for his final decision. The Deputy Administrator has considered the record in its entirety, and pursuant to 21 CFR 1316.67, hereby issues his final order based upon findings of fact and conclusions of law as hereinafter set forth. The Deputy Administrator adopts the Opinion and Recommended Decision of the Administrative Law Judge, and finds as follows:

On January 21, 1997, the Respondent submitted a prior application to DEA as a manufacturer of marijuana for human consumption. The Respondent proposed to rent space on its property to individuals qualifying under California State law as medical marijuana patients, who would then cultivate marijuana for personal consumption, leaving the mature stalks for Respondent to process into paper. On April 17, 1998, DEA issued an Order to Show Cause seeking to deny the application on grounds that the Respondent was not authorized by the State of California to cultivate marijuana. The Respondent filed a timely request for hearing, and the matter was docketed before Judge Bittner as Church of the Living Tree, DEA Docket No. 98-26 (Church of the Living Tree 1). On May 21, 1998, the Government filed a motion summary disposition, alleging inter alia, that California law did not permit cultivation or harvesting of marijuana, and as a result of Respondent's lack of state authorization to manufacture marijuana for non-human consumption, DEA could not grant its application for registration as a matter of law.

In response to the Government's motion, and with arguments similar in scope to its present request for registration, the Respondent asserted in relevant part that the purpose of its application as a bulk manufacturer of medical marijuana was decidedly ``for Human Consumption'' and in compliance with California law. On July 31, 1998, Judge Bittner issued a recommended decision, in which she granted the Government's motion for summary disposition and recommended that the Respondent's application be denied.

In his final order published as Church of the Living Tree, 63 FR 69,674 (1998), the then-Deputy Administrator found that from a reading of the Respondent's marijuana manufacturing proposal, ``* * * it is clear that Respondent will be renting space on its property to others, but [Respondent] will not be the one manufacturing marijuana. Therefore * * * since Respondent will not be manufacturing marijuana nor is it proposing to manufacture marijuana, its application to be a manufacturer of marijuana must be denied.'' 21 U.S.C. 822(a) and 823(a). The then-Deputy Administrator added, ``* * * if Respondent's application is for registration to manufacture marijuana for non-human consumption, then it would have to be denied because California does not allow the cultivation of marijuana for non-human consumption.''

As noted above, on June 18, 1998, the Respondent submitted its most recent application for DEA registration as a manufacturer of marijuana in the category of bulk synthesizer-extractor. In support of the application, the Respondent asserted that its intentions are to cultivate medical marijuana as a cooperative farm of California patients qualifying under the terms of the Compassionate Use Act of 1996. The Respondent further contends that Art.I, sec. 8 and the Tenth Amendment to the United States Constitution provides the right to States to regulate their internal affairs. Therefore Respondent argues, since the proposes uses for its registration complies with California law, Respondent's pending application should be granted.

In the April 17, 2001, Opinion and Recommended Decision, Judge Bittner found that while Respondent seeks registration as a bulk synthesizer-extractor of marijuana, and although the Respondent is apparently willing to modify its application to the ``non-human consumption'' category, the Respondent's application cannot be granted under either category. The Deputy Administrator concurs with this finding. DEA concluded in Church of the Living Tree I that if Respondent rents out space to medical marijuana patients to cultivate marijuana, Respondent will be the entity doing the cultivation and therefore cannot be registered as a bulk synthesizer-extractor of marijuana. With respect to its instant application, the Respondent has not indicated that it seeks registration for purposes of growing marijuana for non-human consumption. In any event, there remains a lack of evidence before the Deputy Administrator that California law provides for the cultivation of marijuana for non-human consumption.

The Respondent has once again submitted an application for registration

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as a manufacture of marijuana for human consumption. Such use of a DEA registration is not in conformity with provisions of the Controlled Substances Act. As noted above marijuana is listed in Schedule I of the Controlled Substances Act (CSA). 21 U.S.C. 812(c); 21 CFR 1303.11. The CSA defines Schedule I controlled substances as those drugs or other substances that have ``a high potential for abuse,'' ``no current accepted medical use in treatment in the United States,'' and ``a lack of accepted safety for use * * * under medical supervision.'' Also, every drug listed in Schedule I of the CSA lacks approval for marketing under the Federal Food Drug and Cosmetic Act (FDCA). Therefore, the Food and Drug Administration (FDA) has not approved marijuana for marketing as a drug.

The deleterious effects of marijuana use have been outlined extensively in previous DEA final orders and will not be repeated at length here. Marion ``Molly'' Fry, M.D. at 79015. See also, 66 FR 20038 (2001) 57 FR 10499 (1992). However, it bears mentioning again that the numerous significant short-term side effects and long term risks linked to smoking marijuana, include damage to brain cells; lung problems such as bronchitis and emphysema; a weakening of the body's antibacterial defenses in the lungs; the lowering of blood pressure; trouble with thinking and concentration; fatigue; sleepiness and the impairment of motors skills. Id.

Marijuana was placed in Schedule I for the same fundamental reason that it has never been approved for sale by the FDA; there have never been any sound scientific studies which demonstrate that marijuana can be used safely and effectively as medicine. See 66 FR 20038 (April 18, 2001) (DEA final order denying petition to initiate proceedings to reschedule marijuana). The Supreme Court recently explained the legal significance of marijuana's placement in Schedule I of the CSA:

Whereas some other drugs (those in Schedules II through V) can be dispensed and prescribed for medical use, see 21 U.S.C. 829, the same is not true for marijuana. Indeed, the purposes of the Controlled Substances Act, marijuana has ``no currently accepted medical use'' at all.

United States v. Oakland Cannabis Buyers' Cooperative, 532 U.S. 482, 491 (2001).

Federal law prohibits human consumption of marijuana outside of FDS-approved, DEA registered research. Id. at 490 (``For marijuana (and other drugs that have been classified as `schedule I' controlled substances), there is but one express exception, and it is available only for Government approved research projects, section 823(f).''). Id. at 495 n.7.

In light of the Respondent's pending DEA application which by law cannot be granted, the Deputy Administrator concurs with Judge Bittner that there are no material disputed facts in this matter. Accordingly, the Government's motion for summary disposition was properly entertained and granted. It is well settled that when no question of material fact is involved, or when the material facts are agreed upon, a plenary, adversary administrative proceeding involving evidence and cross-examination of witnesses is not obligatory. The rationale is that Congress does not intend administrative agencies to perform meaningless tasks. See Gilbert Ross, M.D., 61 FR 8664 (1996); Philip E. Kirk, M.D., 48 FR 32,887 (1983), aff'd sub nom Kirk v. Mullen, 749 F.2d 297 (6th Cir. 1984); NLRB v. International Association of Bridge, Structural and Ornamental Ironworkers, AFL-CIO, 549 F.2d 634 (9th Cir. 1977). For the above-stated reasons, the application of Respondent must be denied.

Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in him by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that the application for a DEA Certificate of Registration submitted by the Church of the Living Tree, be, and it hereby is, denied. This order is effective April 9, 2003.

Dated: March 26, 2003. John B. Brown, III, Deputy Administrator.

[FR Doc. 03-8590 Filed 4-8-03; 8:45 am]

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