[Federal Register: May 3, 2007 (Volume 72, Number 85)]
[Notices]
[Page 24607-24608]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my07-82]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 06-52]
Green Acres Farms, Inc.; Denial of Application
On February 6, 2006, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Green Acres Farms, Inc., (Respondent) of Tacoma,
Washington. The Show Cause Order proposed to deny Respondent's pending
application for registration as a bulk manufacturer of the Schedule I
controlled substances marijuana and tetrahydrocannabinols, on the
grounds that its registration would be inconsistent with the public
interest, see 21 U.S.C. 823(a), and with the United States' obligations
under the Single Convention on Narcotic Drugs, March 30, 1961, 18
U.S.T. 1407. Show Cause Order at 1.
More specifically, the Show Cause Order alleged that on June 28,
2004, Respondent's owners, Mr. and Mrs. Keith Yale, submitted an
application to DEA to manufacture marijuana and tetrahydrocannabinols
and that DEA then sent the Yales a standardized questionnaire which all
applicants for registration to manufacture controlled substances in
Schedules I and II are required to complete. See id. The Show Cause
Order alleged that Respondent's owners indicated on the questionnaire
that the firm sought to grow marijuana to supply ``persons who qualify
to receive marijuana under the Washington State Medical Use of
Marijuana Act.'' See id. at 2. The Show Cause Order further alleged
that Mrs. Yale stated on the questionnaire that she had obtained
authorization from a physician to use marijuana and that she planned to
use some of the marijuana grown by Respondent. Id. The Show Cause Order
also alleged that Respondent intended ``to supply marijuana to patients
in other states, which have laws that permit the `medical use' of
marijuana,'' and that Respondent also intended to distribute its
marijuana to Washington-based pharmacies and cooperatives. Id. The Show
Cause Order alleged that Respondent's owners had also stated that they
intended to extract THC from their marijuana and develop an ingestible
form of medication to create an alternative to smoked marijuana. Id.
The Show Cause Order further alleged that neither marijuana nor
tetrahydrocannabinols have been approved under the Food, Drug and
Cosmetic Act, as ``safe and effective'' for medical use, and neither
drug has an ``accepted medical use in * * * the United States.'' Id. at
3 (citing 21 U.S.C. 321(p) & 812(b)(1)(B)). Relatedly, the Show Cause
Order alleged that Respondent's proposed distribution of marijuana
would constitute a felony under 21 U.S.C. 841(a)(1). Id. at 4. Finally,
the Show Cause Order alleged that Respondent's proposed activity was
not permitted under the Washington act. See id. at 4.
Respondent requested a hearing; the matter was assigned to
Administrative Law Judge (ALJ) Mary Ellen Bittner. Thereafter, the
Government moved for summary disposition.\1\
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\1\ Upon being directed by the ALJ to file a response to the
Government's motion, Respondent sought a six month extension. The
ALJ concluded, however, that an extension of such duration would
unduly delay the proceedings. Instead, the ALJ granted Respondent a
sixty day extension.
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The basis for the Government's motion was that marijuana and
tetrahydrocannabinols have not been approved under the Food, Drug and
Cosmetic Act, 21 U.S.C. 321(p), as ``safe and effective'' for medical
use. Gov. Mot. at 3-4. The Government also argued that both marijuana
and tetrahydrocannabinols are Schedule I controlled substances and
``have no currently accepted medical use in treatment in the United
States.'' Id. (citing 21 U.S.C. 812(b)(1)(B)). Relatedly, the
Government argued that ``there is a lack of accepted safety for use of
these [drugs] under medical supervision.'' Id. (citing 21 U.S.C.
812(b)(1)(C)). The Government further noted this Agency's previous
denial of a similar application to grow marijuana for medical use. Id.
at 5 (citing Church of the Living Tree, 68 FR 17403 (2003)).
The Government also argued that in United States v. Oakland
Cannabis Buyer's Coop, 532 U.S. 483 (2001), the Supreme Court had
rejected the ``medical necessity'' defense raised by an entity which
distributed marijuana for purportedly medical purposes. Gov. Mot. at 5.
According to the Government, ``any distribution of marijuana as
proposed by [Respondent] would constitute an unlawful distribution of a
controlled substance in violation of 21 U.S.C. 841(a)(1), a felony.''
The Government further contended that unless and until ``these
substances are
[[Page 24608]]
approved [by the FDA] for medical use and placed in a Schedule other
than Schedule I, DEA cannot grant an application to manufacture * * *
these substances to anyone who seeks to manufacture [them] for the
purpose of distributing * * * or dispensing [them] to[ ] `patients.' ''
Id.
The Government also argued that marijuana and tetrahydrocannabinols
are Schedule I controlled substances under Washington law and that the
State's Medical Use of Marijuana Act creates only ``a narrow exception
to the classification of marijuana as a Schedule I controlled
substance.'' Id. at 5-6. According to the Government, the exception
allows only a ``qualifying patient'' to possess marijuana, and such
person may only `` `possess no more marijuana than is necessary for the
patient's personal, medical use, not exceeding the amount necessary for
a sixty-day supply.' '' Id. at 6 (quoting RCW section
69.51A.040(2)(b)). The Government thus contends that Respondent's
proposed activities go ``well beyond what is permitted to be
manufactured under applicable Washington * * * law,'' and thus
Respondent would be non-compliant with state law. Id. (citing 21 U.S.C.
823(a)(2)) (requiring Attorney General to consider ``compliance with
applicable State law'' in considering application to manufacture
Schedule I controlled substances).
In its submission, Respondent's owners stated that ``there are no
witnesses,'' that ``[a]ll documents have been submitted,'' and that
``[o]ther testimony ha[d] been submitted in the'' questionnaire they
had previously sent to DEA. Resp. Letter 1 (July 11, 2006).
Respondent's owners further stated that it was their ``intention to
manufacture, package and sell [marijuana] to the various authorized
outlets (state pharmacies within the state of Washington).'' Id. With
respect to the legal issue presented, Respondent stated that it is
``[t]he position and law of the State of Washington * * * that certain
qualified persons in this State have the right as given by the voice of
the people to possess and use marijuana for specific medical needs as
described in Washington State law.'' Id. Respondent further maintained
that ``DEA should allow the State of Washington and [itself] to engage
[in] the legal and correct distribution of marijuana.'' Id.
Concluding that there were no material facts in dispute, the ALJ
granted the Government's motion. As the ALJ explained, marijuana and
tetrahydrocannabinols ``have a high potential for abuse, have no
currently accepted medical use in treatment, and lack safety for use in
treatment under medical supervision.'' ALJ Dec. at 3. Because ``these
substances cannot be manufactured for distribution to patients for
medical use,'' the ALJ concluded that DEA ``cannot register an
applicant with the intention to manufacture and distribute contrary to
federal law.'' Id. Finally, the ALJ also held that the Washington state
law exception does not ``extend to the manufacturing of these
substances and therefore Respondent lacks state authority'' to conduct
its proposed activity. The ALJ thus recommended that I deny
Respondent's application and forwarded the record to me for final
agency action. Neither party filed exceptions.
Having considered the record as a whole, I adopt the ALJ's opinion
in its entirety and deny Respondent's application. Section 303(a) of
the Controlled Substances Act provides that the ``Attorney General
shall register an applicant to manufacture controlled substances in
schedule I or II if he determines that such registration is consistent
with the public interest.'' 21 U.S.C. 823(a). While Congress provided
six factors to be considered in determining the public interest, id.,
it is well settled that I may rely on any one or a combination of
factors, and may give each factor the weight I deem appropriate in
determining whether an application for registration should be denied.
See ALRA Laboratories, Inc., 59 FR 50620, 50621 (1994). Moreover, I am
``not required to make findings as to all of the factors.'' Hoxie v.
DEA, 419 F.3d 477, 482 (6th Cir. 2005); Morall v. DEA, 412 F.3d 165,
173-74 (D.C. Cir. 2005).
Here, it is clear that Respondent's proposed activity would not
comply with applicable Federal and State laws and would be inconsistent
with public health and safety. See 21 U.S.C. 823(a)(2) & (6). Congress
placed marijuana (and tetrahydrocannabinols) on Schedule I based on its
determination that both substances have `` `no currently accepted
medical use' at all.'' Oakland Cannabis Buyers, 532 U.S. at 483, 491
(2001). Until Congress revises that determination, it is a federal
criminal offense to manufacture either of these substances for any
purpose other than to supply an FDA pre-approved research project. See
Gonzales v. Raich, 545 U.S. 1, 14 (2005). Moreover, it also appears
that Respondent's proposed activities would violate Washington law. See
State v. Tracy, 147 P.3d 559, 561-62 (Wash. 2006) (upholding conviction
for possession and manufacturing of marijuana because ``only qualifying
patients are entitled to the defense under the act''). Accordingly,
Respondent's registration would be inconsistent with the public
interest. See 21 U.S.C. 823(a).
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(a), as well
as by 28 CFR 0.100(b) & 0.104, I hereby order that the application of
Green Acres Farm, Inc., for a DEA Certificate of Registration to
manufacture marijuana and tetrahydrocannabinols be, and it hereby is,
denied. This order is effective June 4, 2007.
Dated: April 25, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-8454 Filed 5-2-07; 8:45 am]
BILLING CODE 4410-09-P