[Federal Register Volume 72, Number 85 (Thursday, May 3, 2007)]
[Notices]
[Pages 24607-24608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8454]


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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