[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]
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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
[[Page 17404]]
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error, and the agency subsequently rescinded the prior final order by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
[[Page 17405]]
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]
BILLING CODE 4410-09-M