Craker v. Drug Enforcement Administration

United States Court of Appeals
For the First Circuit
No. 09-1220
LYLE E. CRAKER,
Petitioner,
v.
DRUG ENFORCEMENT ADMINISTRATION,
Respondent.
PETITION FOR REVIEW OF AN ORDER OF THE
DRUG ENFORCEMENT ADMINISTRATION
Before
Torruella, Lipez and Howard,
Circuit Judges.
Theodore P. Metzler, with whom Eugene Gulland, Covington &
Burling LLP, M. Allen Hopper, ACLU Foundation of Northern
California, Sarah R. Wunsch and ACLU of Massachusetts were on
brief, for petitioner.
Mark T. Quinlivan, Assistant United States Attorney, with whom
Carmen M. Ortiz, United States Attorney, was on brief, for
respondent.
April 15, 2013
HOWARD, Circuit Judge. Petitioner Lyle E. Craker, a
professor at the University of Massachusetts, seeks review of an
order from the Drug Enforcement Administration ("DEA") denying his
application for registration to cultivate marijuana for medical
research. After review of the administrative record, we deny the
petition.
I. Statutory Landscape
In an effort to consolidate the nation's drug laws and
increase federal enforcement capabilities, Congress enacted the
Comprehensive Drug Abuse and Prevention and Control Act in 1970.
See Gonzales v. Raich, 545 U.S. 1, 11-12 (2005). Included within
that Act was the Controlled Substances Act ("CSA"), "a
comprehensive regime to combat the international and interstate
traffic in illegal drugs." Id. at 12. While observing that many
drugs within the purview of the CSA "have a useful and legitimate
medical purpose and are necessary to maintain the health and
general welfare of the American people," 21 U.S.C. § 801(1),
Congress also determined that the health and welfare of Americans
were detrimentally affected by "[t]he illegal importation,
manufacture, distribution, and possession and improper use of
controlled substances." Id. § 801(2).
Consonant with these concerns, "Congress devised a closed
regulatory scheme making it unlawful to manufacture, distribute,
dispense, or possess any controlled substance except in a manner
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authorized by the CSA." Raich, 545 U.S. at 13 (citing 21 U.S.C.
§§ 841(a)(1), 844(a)). Under this regime, controlled substances
were organized into five schedules, reflective of their accepted
medical uses, their potential for abuse, and their psychological
and physical effects. Id. at 13-14; 21 U.S.C. § 812. Congress
placed marijuana in schedule I, the most stringently controlled
group. 21 U.S.C. § 812(c).1 A schedule I drug "has a high
potential for abuse . . . [,] has no currently accepted medical use
in treatment in the United States[, and] . . . [lacks] accepted
safety for use . . . under medical supervision." Id. § 812(b)(1).
The manufacture of a schedule I substance is a criminal
offense unless the manufacturer has registered with the Attorney
General. Id. § 822(a)(1).2 The CSA provides that the Attorney
General3 "shall register an applicant to manufacture substances in
1
At the request of the Assistant Secretary of Health,
Education and Welfare (now Health and Human Services), marijuana
was originally classified under Schedule I on a preliminary basis,
pending the "completion of certain studies." Gonzales v. Raich,
545 U.S. 1, 14 (2005). The CSA allows for transfer of substances
to, from, or between schedules. 21 U.S.C. § 811. Although
considerable efforts have been made to reschedule marijuana, it
remains a Schedule I substance. Raich, 545 U.S. at 14-15 n.23; see
also Americans for Safe Access v. Drug Enforcement Admin., 706 F.3d
438, 449-452 (D.C. Cir. 2013) (finding that DEA's denial of
rescheduling petition was not arbitrary or capricious).
2
The CSA also contains separate registration provisions
relating to "distributors" and "practitioners" that are not
implicated in this case.
3
The Attorney General has delegated registration authority to
the Administrator of the DEA. 28 C.F.R. § 0.100(b).
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schedule I or II if he determines that such registration is
consistent with the public interest and with United States
obligations under international treaties, conventions or protocols
in effect on May 1, 1971." Id. § 823(a). The "public interest"
determination must be based on the following statutory factors:
(1) maintenance of effective controls against
diversion of particular controlled substances
and any controlled substance in schedule I or
II compounded therefrom into other than
legitimate medical, scientific, research, or
industrial channels, by limiting the
importation and bulk manufacture of such
controlled substances to a number of
establishments which can produce an adequate
and uninterrupted supply of these substances
under adequately competitive conditions for
legitimate medical, scientific, research, and
industrial purposes;
(2) compliance with applicable State and local
law;
(3) promotion of technical advances in the art
of manufacturing these substances and the
development of new substances;
(4) prior conviction record of applicant under
Federal and State laws relating to the
manufacture, distribution, or dispensation of
such substances;
(5) past experience in the manufacture of
controlled substances, and the existence in
the establishment of effective control against
diversion;
(6) such other factors as may be relevant to
and consistent with the public health and
safety.
Id. § 823(a)(1)-(6). The applicant carries the burden of proof at
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any administrative hearing on a registration application. 21
C.F.R. § 1301.44(a).
Since 1968, the National Center for Natural Products
Research ("NCNPR") at the University of Mississippi has held the
necessary registration and a government contract to grow marijuana
for research purposes.4 Lyle E. Craker, 74 Fed. Reg. 2101, 2104
(Drug Enforcement Admin. Jan. 7, 2009) (Denial of Application)
("Craker II"). The contract is administered by the National
Institute on Drug Abuse ("NIDA"), a component of the National
Institutes of Health ("NIH"), which, in turn, is a component of the
Department of Health and Human Services("HHS"). Id. The contract
is opened for competitive bidding every five years. Id. The NCNPR
is the only entity registered by the DEA to manufacture marijuana.
Lyle E. Craker, Ph.D, No. 05-16 (Drug Enforcement Admin. Feb. 12,
2007) (opinion, recommended ruling and decision) ("Craker I").
Among the "international treaties, conventions or
protocols" referred to in section 823(a), the CSA implements the
provisions of the Single Convention on Narcotic Drugs, 18 U.S.T.
1407 ("Single Convention"), in an effort "to establish effective
control over international and domestic traffic in controlled
substances." 21 U.S.C. § 801(7). As relevant to this proceeding,
4
NCNPR's registration and contract incepted prior to the
enactment of the CSA. Lyle E. Craker, 74 Fed. Reg. 2101, 2104
(Drug Enforcement Admin. Jan. 7, 2009) (Denial of Application)
("Craker II").
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Article 28 of the Single Convention addresses cultivation of
marijuana -- referred to therein by its taxonomic genus, cannabis
-- with reference to "the system of controls as provided in article
23 respecting the control of the opium poppy." Pursuant to article
23, any signatory nation that "permits the cultivation of
[marijuana or opium]" must designate one or more agencies to:
license cultivators and designate where plants may be grown;
purchase and take physical possession of each year's crops; and
have the exclusive right of importing, exporting, wholesale trading
and maintaining stocks other than those held by manufacturers of
opium alkaloids, medicinal opium or opium preparations.
II. Adjudication of Dr. Craker's Application
Dr. Craker, a professor in the University of
Massachusetts' Department of Plant, Soil and Insect Sciences,
applied to the DEA for registration to manufacture marijuana for
clinical research in 2001. At the DEA's request, he supplemented
his application in August 2002. He stated that "a second source of
plant material is needed to facilitate privately funded [Food and
Drug Administration ("FDA")]-approved research into medical uses of
marijuana, ensuring a choice of sources and an adequate supply of
quality, research-grade marijuana for medicinal applications."
Craker II, 74 Fed. Reg. at 2107. Dr. Craker indicated that his
production costs would be underwritten by a grant from the
Multidisciplinary Association for Psychedelic Studies ("MAPS"), a
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non-profit, tax-exempt research and education organization seeking
to develop marijuana into an FDA-approved prescription medicine.
Id. at 2106.
In December 2004, a DEA official issued an order to show
cause, proposing the denial of Dr. Craker's registration
application. Id. at 2101; see 21 U.S.C § 824(c); 21 C.F.R.
§ 1301.37(a), (c). The order first concluded that Dr. Craker's
registration "would not be consistent with the public interest as
that term is used in 21 U.S.C. § 823(a)." Craker II, 74 Fed. Reg.
at 2101. The order also concluded that registration would be
inconsistent with the United States' obligations under the Single
Convention. Id. Dr. Craker timely requested a hearing, see 21
C.F.R. § 1301.37(d), which was conducted by an administrative law
judge ("ALJ") over nine days in August and December 2005. See
generally 21 C.F.R. § 1316.41-.67 (outlining hearing procedures).
In February 2007, the ALJ issued an eighty-seven page
opinion, recommending that the DEA grant Dr. Craker's application.
Craker I. The ALJ first concluded that the Single Convention was
not a bar to Dr. Craker's registration, noting that it appeared
that marijuana grown by the NCNPR or any other registrant for use
in research would qualify as either "medicinal" or "special stocks"
under the treaty, and thus not be prohibited by a government
monopoly requirement. See Craker I at 82; Craker II, 74 Fed. Reg.
at 2102.
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The ALJ also found that Dr. Craker's application
satisfied the "public interest" requirements of 21 U.S.C. § 823(a).
The ALJ first noted a dispute that we will revisit: whether, as
Dr. Craker asserts, the "adequately competitive conditions"
requirement of section 823(a)(1) must be disregarded if there has
been a finding that the applicant can maintain effective controls
against diversion. Craker I at 85; Craker II, 74 Fed. Reg. at
2102-03; see Noramco of Del., Inc. v. Drug Enforcement Agency, 375
F.3d 1148, 1152-54, 1157 n.8 (D.C. Cir. 2004) (noting DEA's
position that supply and competition can be disregarded if
registration does not increase risk of diversion).
The government's position with respect to Dr. Craker's
application was and is that both the diversion and
supply/competition criteria must be satisfied. Without resolving
the issue, the ALJ considered both factors, concluding that Dr.
Craker had adequately proven that there is minimal risk that any
marijuana he cultivated would be diverted. With respect to supply,
the ALJ found that NIDA-approved researchers had not experienced
difficulty obtaining marijuana from NCNPR when it was needed.
Nevertheless, the ALJ found the supply to be inadequate because
NIDA refused to supply some researchers who held DEA registrations
and approvals from HHS. Finally, the ALJ concluded that the
competitive bidding process for renewing the single extant NIDA
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marijuana contract did not amount to "adequate competition" within
the meaning of the statute.
After finding that Dr. Craker satisfied all but one of
the remaining statutory factors -- promotion of technical advances
under section 832(a)(3) -- the ALJ recommended that his application
be granted.
In January 2009, the DEA Deputy Administrator
("Administrator") rejected the ALJ's recommendation and denied Dr.
Craker's application. Craker II, 74 Fed. Reg. at 2133. Turning
first to the Single Convention, the Administrator concluded that
Dr. Craker's application evinced an intent "to distribute marijuana
outside the HHS system." Id. at 2114. In support of this finding,
the Administrator noted that one of Dr. Craker's putative
colleagues, MAPS president Rick Doblin, testified that "[w]hat
we're trying to do is get the [Public Health Service] and NIDA out
of the picture." Id. at 2114-15. Dr. Craker's intent, the
Administrator ruled, is to elide "the very Government monopoly over
the wholesale distribution of marijuana that the Single Convention
demands. Thus, from the outset . . . [Dr. Craker]'s proposed
registration cannot be reconciled with United States obligations
under the treaty." Id. at 2115.
The Administrator additionally rejected Dr. Craker's
assertion that his plans fell within the Single Convention's
"medicinal opium" exception both because marijuana currently has no
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accepted use in the United States, id. at 2116-17, and that even if
considered analogous to medicinal opium, Dr. Craker's proposal
would run afoul of the Single Convention's "central theme," that a
single national agency must control the distribution and production
of raw marijuana used for research. Id. at 2117.
Next, the Administrator found that granting Dr. Craker's
application would not be within the public interest, as required by
21 U.S.C. § 823(a). In so doing, the Administrator first agreed
with the ALJ that the DEA had inconsistently construed section
823(a)(1) in the past, at times calling for consideration of supply
and competition regardless of the potential for diversion and at
other times ignoring adequacy of supply and competition if
effective diversion controls were in place. Id. at 2118. After a
lengthy disquisition on the issue, id. at 2127-32, the
Administrator determined that a registrant must prove both that
effective controls against diversion are in place and that supplies
and competition are inadequate. Id. at 2133 ("The alternative
interpretation, though found to be permissible, . . . provides no
mechanism to prevent the proliferation of bulk suppliers . . .
beyond that necessary to adequately supply . . . these materials
under adequately competitive conditions. [This] heightens the risk
of oversupply, which, in turn increases the risk of diversion.").
The Administrator then concluded that the existing supply
and quality of marijuana was adequate, observing that NIDA had been
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able to successfully supply research efforts and that the NIDA
denials cited by Dr. Craker were not due to insufficient supply,
but rather were due to lack of scientific merit. Id. at 2119. The
Administrator further accepted the ALJ's finding that the existing
marijuana supply was of sufficient quality to meet the research
community's needs, id. at 2102, observing further that Dr. Craker's
opposing anecdotal evidence of shortcomings in taste, potency and
freshness was countered by evidence of researchers' "overall
satisfaction" with marijuana received from NIDA. Id. at 2120.
In addressing the "adequately competitive conditions"
criterion, the Administrator focused on cost, noting that NIDA
provided marijuana either at cost (to privately-funded researchers)
or for free (to HHS-funded researchers), at no profit to NIDA. Id.
at 2121. Thus, Dr. Craker could not claim that his entry into
manufacturing would lower costs to researchers, beyond a
generalized reference to the idea that more competition would lead
to lower costs, a claim which itself was belied by the fact that,
as MAPS's president Mr. Doblin noted, MAPS's costs would be
affected by its own profit-making motivation. Id. As a final
consideration under section 823(a)(1), the Administrator accepted
the government's reasoning that the process by which the NIDA
marijuana contract was opened periodically for competitive bidding
helped to ensure adequate competition. Id. at 2121-22.
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The Administrator next accepted the ALJ's recommendations
concerning sections (2), (3) and (4) of 823(a), agreeing that Dr.
Craker had adequately demonstrated that he would abide by
applicable laws, that he had failed to demonstrate that his
proposed activities would promote scientific advancements in the
field, and that he had never been convicted of violating any
controlled substance law. Id. at 2123-25. With respect to section
821(a)(5), the Administrator noted that while Dr. Craker had no
experience in the manufacture of controlled substances, he would
have satisfactory diversion control in place. Id. at 2125-26.
Finally, the Administrator concluded that Mr. Doblin's admission
that he regularly smoked marijuana in violation of federal drug
laws and that he was to play a central role in the proposed
manufacturing operation was another factor weighing against Dr.
Craker's application. Id. at 2126-27; 21 U.S.C. § 821(a)(6).
The Administrator ultimately concluded that any one of
three negative findings could provide a "compelling" basis to deny
the application: conflict with the Single Convention; existing
adequate supply and competition; and Mr. Doblin's conduct and
involvement. Craker II, 74 Fed. Reg. at 2133. Concurrent with the
denial, however, the Administrator also granted Dr. Craker fifteen
days in which to file a motion for reconsideration to refute any
facts of which the Administrator had taken official notice during
the proceedings. Id. at 2108 n.24; see 21 C.F.R. § 1316.59(e).
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Availing himself of the opportunity, Dr. Craker filed a
motion for reconsideration in January 2009. He also requested that
the hearing be reopened for him to call additional witnesses. On
February 9, 2009, the Administrator issued an order permitting
further briefing and stating that she would decide on the basis of
those submissions whether to grant Dr. Craker's request to reopen
the administrative hearing or grant his request for
reconsideration. In December 2010, the Administrator denied the
request to reopen the hearing, but allowed Dr. Craker to further
supplement the record and to raise new arguments. In August 2011,
the Administrator denied the motion for reconsideration. Lyle E.
Craker, Ph.D, 76 Fed. Reg. 51403, (Drug Enforcement Admin. Aug. 8,
2011) (order regarding officially noticed evidence and motion for
reconsideration) ("Craker III").
The Administrator rejected claims that Dr. Craker had
made alleging political and institutional bias, as well as his
argument that the FDA, rather than NIDA, should assess registration
applications under 21 U.S.C. § 823. Id. at 51406-08. The
Administrator also reiterated the finding that Dr. Craker's
registration would be inconsistent with the Single Convention. Id.
at 51410. At the same time, the Administrator backed away somewhat
from the previous conclusion with respect to Mr. Doblin, observing
that some controls could conceivably be put into place to alleviate
concerns over his personal use of marijuana, but that the other
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grounds for denial of the application rendered analysis of that
issue unnecessary. Id. at 51411-12.
The final pieces of the background puzzle emerge from Dr.
Craker's initial filing with us after the DEA issued Craker II. On
February 13, 2009, while his motion for reconsideration was
pending, Dr. Craker filed a petition for review of Craker II in
this court, pursuant to 21 U.S.C. § 877. At the same time, he
filed a motion to stay the appellate proceedings and hold them in
abeyance, which we granted on March 12, 2009, until such time as
the motion for reconsideration before the Administrator was acted
on. In his appellate motion, Dr. Craker indicated that the goal of
the motion was to preserve his appeal rights in the event that
Craker II was deemed to be a "final decision" within the meaning of
21 U.S.C. § 877, thus triggering the statute's 30-day deadline for
seeking judicial review. On August 24, 2011, after receiving
notification that Craker III had been issued, we lifted the
abeyance and permitted the petition for review to proceed.
III. Analysis
A. Jurisdiction
The government argues that we are without jurisdiction to
address the merits of Dr. Craker's petition. Its jurisdictional
theory starts with the fact that Congress has permitted judicial
review only of "final" agency decisions. 21 U.S.C. § 877; see also
John Doe, Inc. v. Drug Enforcement Admin., 484 F.3d 561, 565 (D.C.
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Cir. 2007) (final decision requirement under § 877 is
jurisdictional in nature); Fry v. Drug Enforcement Admin., 353 F.3d
1041, 1044 (9th Cir. 2003); Nutt v. Drug Enforcement Admin., 916
F.2d 202, 203 (5th Cir. 1990) (same). The government's position is
that the only final decision is Craker III, from which Dr. Craker
did not seek review. While the government acknowledges that Dr.
Craker did seek review of Craker II, it argues that the pendency of
the motion for agency reconsideration of that decision deprived the
order of finality, and thus us of jurisdiction. The premature
petition for review, the government further contends, did not ripen
so as to vest us with jurisdiction once the agency issued its final
decision on reconsideration.
The government relies on a rule, established by the D.C.
Circuit and adopted by others, whereby a petition for review filed
during the pendency of a motion for agency reconsideration is
"incurably premature and in effect a nullity." Gorman v. NTSB, 558
F.3d 580, 586 (D.C. Cir. 2009) (internal quotation omitted);
accord Council Tree Commc'ns, Inc. v. FCC, 503 F.3d 284, 287 (3d
Cir. 2007). In the cases in which that rule has been applied,
however, either the governing statute or the implementing
regulations expressly provided for agency reconsideration. See,
e.g., Council Tree Commc'ns, 503 F.3d at 286 (petition for
reconsideration of FCC order pursuant to 47 C.F.R. § 1.106);
Clifton Power Corp. v. FERC, 294 F.3d 108, 110 (D.C. Cir. 2002)
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(motion for rehearing and reconsideration of FERC order pursuant to
16 U.S.C. § 825(b)). No similar procedural guarantee existed here,
which is why Dr. Craker filed his protective petition with us.
Nevertheless, the government argues that the facts of this case
still favor applying the "incurably premature" rule. The
Administrator expressly afforded Dr. Craker the opportunity to
refute the facts of which she had taken official notice by filing
a motion for reconsideration and, after Dr. Craker availed himself
of that opportunity and also sought broader reconsideration of the
order, permitted him to file supplemental briefing. Accordingly,
the government argues, Dr. Craker's appeal was premature despite
the fact that neither the CSA nor DEA's implementing regulations
provide for a motion for reconsideration.5
It is not clear that even those courts that have adopted
the maturation rule would apply it here, where the opportunity
granted to the petitioner was limited to contesting facts of which
the agency had taken official notice, while broader reconsideration
of the factual and legal bases for the agency's final order
remained only, at the time of the filing of the petition for
review, a mere possibility. See supra p. 13 (noting that the
Administrator's February 9, 2009 order withheld judgment on the
propriety of Dr. Craker's motion for reconsideration). In
5
The parties do not dispute that motions for reconsideration
of DEA orders are not contemplated. We assume, without deciding,
the correctness of that position.
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concluding that, where a party's original petition for review of an
agency order was unripe, that party must file a new petition upon
disposition of its motion for reconsideration, the D.C. Circuit
explained:
We develop this bright line test to discourage the
filing of petitions for review until after the
agency completes the reconsideration process. If a
party determines to seek reconsideration of an
agency ruling, it is a pointless waste of judicial
energy for the court to process any petition for
review before the agency has acted on the request
for reconsideration.
TeleSTAR, Inc. v. FCC, 888 F.2d 132, 134 (D.C. Cir. 1989).
The D.C. Circuit has, however, declined to apply the rule
where the motion for reconsideration was not timely filed. That is
because, "at least where . . . the agency does not consider the
merits of the tardy request," there is no "possibility that the
order complained of will be modified in any way which renders
judicial review unnecessary." See Gorman, 558 F.3d at 587
(internal quotation omitted). Similarly, the possibility of
concurrent jurisdiction and the judicial economy concerns that
arise from it, while not wholly eliminated, are considerably
diminished in cases, such as this one, in which reconsideration may
or may not have been permitted in the agency's discretion. See
Craker III, 76 Fed. Reg. at 51405 (explaining the decision to
permit reconsideration as an "exercise of [the Administrator's]
discretion"); see also City of Colo. Springs v. Solis, 589 F.3d
1121, 1131 (10th Cir. 2009) (concluding that the rule announced in
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ICC v. Bhd. of Locomotive Eng'rs, 482 U.S. 270, 284 (1987), whereby
the timely filing of a motion for administrative reconsideration
renders the underlying order non-final for purposes of judicial
review, "is not applicable in this case because the [agency] has
not established a rehearing or reconsideration procedure for [the
type of order at issue]").
Moreover, such jurisdictional concerns are further
alleviated here, because we suspended and then resumed
consideration of a petition for review upon completion of the
reconsideration process. As the Supreme Court has observed, "a
stay is as much a refusal to exercise federal jurisdiction as a
dismissal." Moses H. Cone Mem. Hosp. v. Mecury Const. Corp., 460
U.S. 1, 28 (1983); see also In re Graves, 69 F.3d 1147, 1151 (Fed.
Cir. 1995) (concluding that although the court "cannot exercise
jurisdiction over the appeal before the [agency] enters its
reconsideration decision," its jurisdiction "was, in effect,
suspended until the [agency] acted"); Northside Sanitary Landfill,
Inc. v. Thomas, 804 F.2d 371, 379 (7th Cir. 1986) ("Once our
jurisdiction has been [timely] invoked by a petition for review, it
makes little sense to require an amendment to the petition to
preserve that jurisdiction only because the agency has ruled on the
motion for reconsideration.").
Given that, in the circumstances of this case, holding
the petition in abeyance served equally the interests of judicial
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economy, we are not persuaded that we should impose a bright line
test requiring dismissal or amendment of a petition filed during
the pendency of a motion for reconsideration, at least where the
reconsideration process is ad hoc, as here. We also hesitate to
apply such a rule retroactively in any event. See TeleSTAR, Inc.,
888 F.2d at 134 (giving newly adopted "incurably premature" rule
prospective effect only); see generally Crowe v. Bolduc, 365 F.3d
86, 93 (1st Cir. 2004) (noting that in determining whether to give
a new rule prospective effect, we consider, among other factors,
whether "retroactive application give[s] rise to a substantial
inequity"). Accordingly, we conclude that we have jurisdiction to
consider Dr. Craker's petition for review and turn to the merits.6
B. Chevron Analysis
In reviewing the Administrator's decision, we first
address whether Congress has unambiguously spoken to the precise
question that is at issue, Chevron, U.S.A. Inc. v. Natural
Resources Defense Council Inc., 467 U.S. 837, 842-43 (1997). If it
turns out that the statute is ambiguous, then Chevron deference
must be afforded; the agency's interpretation of the statute will
be upheld as long as it is "based on a permissible construction of
the statute." Id. at 843. In the end, we may set aside the
6
As previously noted, Dr. Craker is seeking review of Craker
II, the Administrator's original decision, and not Craker III, the
decision on reconsideration. Given our ultimate disposition, we
needn’t consider the agency’s order in Craker III.
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Administrator's decision if it is arbitrary, capricious, an abuse
of discretion, not supported by substantial evidence, or otherwise
not in accordance with the law. NLRB v. Reg'l Home Care Servs.,
237 F.3d 62, 71 (1st Cir. 2001); see also 5 U.S.C. § 706(2)(A),
(E). A decision is arbitrary and capricious "if the agency has
relied on factors which Congress has not intended it to consider,
entirely failed to consider an important aspect of the problem,
offered an explanation for its decision that runs counter to the
evidence before the agency, or is so implausible that it could not
be ascribed to a difference in view or the product of agency
expertise." Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto.
Ins. Co., 463 U.S. 29, 43 (1983). We may not substitute our
judgment for that of the agency, even if we disagree with its
conclusions. River Street Donuts, LLC v. Napolitano, 558 F.3d 111,
114 (1st Cir. 2009). Here, to set the stage for the Chevron
analysis, we engage in a more detailed review of the decision at
issue.
As previously noted, the Administrator rejected Dr.
Craker's application both because it was inconsistent with the
Single Convention and because it did not meet the "public interest"
requirement of 21 U.S.C. § 823. Because we resolve the matter
under section 823, we need not review the arguments relative to the
Single Convention, since failure to satisfy either is fatal to Dr.
Craker's claim. 21 U.S.C. § 823(a).
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In analyzing the CSA, the Administrator first compared
Congress' treatment of Schedule I and II substances in section
823(a)(1) with that of Schedule III, IV and V substances, as set
forth in section 823(d). Notably, the two statutory sections
contain identical public interest factors, except that in section
(d) -- which deals with substances that Congress regards as less
dangerous -- there is no reference as there is in section (a)(1) to
"limiting supply" and "competitive conditions." Unlike
considerations with respect to less dangerous drugs, then,
according to the Administrator, section 823(a)(1) explicitly sets
out both Congress' stated purpose (to maintain effective controls
against diversion) and how it intends that the objective is to be
achieved (by limiting the number of manufacturers to that which can
produce an adequate and uninterrupted supply under adequately
competitive prices). Craker II, 74 Fed. Reg. at 2118-23.
Moreover, the Administrator also found that section 823(a)(5)'s
mandate to consider "the existence in the establishment of
effective control against diversion" suggests that section (a)(1)'s
reference to diversion is directed toward preventing diversion by
limiting the number of manufacturers. Id. at 2128.
The Administrator also detailed the legislative history
of the CSA to buttress her conclusion, observing that the CSA's
predecessor, the Narcotics Manufacturing Act of 1960, called for
the limitation of manufacturers to the smallest number that could
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produce an adequate, uninterrupted supply, without referencing
competition. Id. Thus, the Administrator concluded, in enacting
the CSA, Congress increased the potential number of approved
manufacturers from that which can produce an adequate and
uninterrupted supply to that which can do so under adequately
competitive conditions. Id.
The Administrator acknowledged that the 1960 Act, unlike
the CSA, referred to allowing only "the smallest number of
establishments that can produce an adequate and uninterrupted
supply," and that the CSA dropped the "smallest number"
formulation. Nevertheless, she concluded that the CSA's continued
use of the term "limiting" retained the concept of an upper limit
on manufacturers as a consideration. Id. at 2128-29 n.105.
Finally, the Administrator cited Justice Department
written testimony which noted the "primary objective" of "effective
control" and that additional manufacturers could be licensed if the
additional licenses do not significantly affect drug control.
Id. at 2129.
1. Chevron Step One
At the outset, we reject each party's contention that
section 823(a)(1) unambiguously supports its respective position.
It is not clear from the text of the section whether, as Dr. Craker
argues, limiting supply is allowed only where diversion is a
concern, or, as the Administrator contends on appeal, the statute
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must be construed to require that limiting supply be the means by
which effective controls against diversion are implemented.
Indeed, as the Administrator observed, 74 Fed. Reg. 2127-32, and as
the DEA concedes, the DEA itself has taken inconsistent positions
on this question. Compare Noramco, 375 F.3d at 1153 (observing
that the DEA argued in one registration (Johnson Matthey) that no
analysis of competition is required), with id. at 1157 (noting that
in a different registration (Penick) the DEA addressed competition
and supply factors). As it does not appear that the statute either
mandates or excludes either side's view, we turn to step two and
resolve whether the administrator's interpretation is a reasonable
one. We hold that it is.
2. Chevron Step Two
We conclude that the government's view prevails at
Chevron's second step. Dr. Craker advances three reasons why this
should not be the outcome. We address them in turn.
First, he argues that the court in Noramco squarely
rejected the DEA's present view. But contrary to this assertion,
the court in Noramco did not hold that section 823(a)(1)
unambiguously required the DEA to forego consideration of supply
and competition if it found no increased difficulty in controlling
diversion. Instead, the court held that the statute did not
directly answer the question, but that the Agency's interpretation
of the statute -- that analysis of competition and supply was
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unnecessary -- was reasonable. Noramco, 375 F.3d at 1153; see also
Chevron, 467 U.S. at 843 n.11 ("The court need not conclude that
the agency construction was the only one it permissibly could have
adopted . . . or even the reading the court would have reached if
the question initially had arisen in a judicial proceeding.").7
Dr. Craker next takes aim at the Administrator's
assessment that section (a)(1) speaks to diversion on a
"registrant-wide" scale, whereas section (a)(5) refers to an
individual registrant. He argues that even if this dichotomy is
permissible, the Administrator failed to demonstrate any diversion
concern. We disagree, as the Administrator cited legislative
history noting Congress' recognition that the risk of diversion
increases with the addition of new manufacturers. 74 Fed. Reg. at
2129.
Finally, Dr. Craker argues that the Administrator did not
adequately explain why the DEA was changing its position from the
one that it had advocated in Noramco. To the contrary, and as
previously noted, Craker II contains a lengthy analysis of that
very issue. 74 Fed. Reg. at 2127-33. "[P]ursuant to Chevron, an
agency's change in precedent is not invalidating if the agency
adequately explains its reasons. The agency's explanation must be
7
We note that Dr. Craker's brief truncates a quote from the
Noramco opinion to make it appear that the DEA's interpretation of
section 823(a)(1) is actually the court's holding of how the
statute must be read.
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accompanied by some reasoning that indicates that the shift is
rational and, therefore, not arbitrary and capricious. This is not
a difficult standard to meet." River Street Donuts, LLC, 558 F.3d
at 115 (internal citations and quotation marks omitted). Here, the
Administrator addressed the agency's prior positions, including
that taken in an opinion that was issued while the instant matter
was pending before the DEA8 -- and explained that the
interpretation now urged better effectuated the CSA. We find its
reasoning sufficient.
Accordingly, we conclude that the Administrator's
interpretation of 21 U.S.C. § 823(a)(1) is a reasonable one, to
which we defer.
3. Administrator's Decision
Dr. Craker's final claim is that, even if the DEA is
permitted to consider supply and competition, the Administrator
erred because Dr. Craker demonstrated that both competition and
supply are inadequate. On the contrary, the Administrator's
findings are supported by the record.
a. Competition
Dr. Craker's argument with respect to competition is
essentially that there cannot be "adequately competitive
conditions" when there is only one manufacturer of marijuana.
8
See Penick Corp. v. Drug Enforcement Admin., 491 F.3d 483(D.C. Cir. 2007).
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Invoking anti-trust doctrine, he asserts that a monopoly cannot
constitute competition within the meaning of the statute.
The Administrator addressed competition through the lens
of price, and observed that NIDA had provided marijuana
manufactured by the University of Mississippi either at cost or
free to researchers, and that Dr. Craker had made no showing of how
he could provide it for less, especially when his associate Mr.
Doblin acknowledged MAPS' profit motive in its manufacturing
enterprise. 74 Fed. Reg. at 2121. Additionally, the Administrator
noted that Dr. Craker is free to bid on the contract when it comes
up for renewal. Id.
We see nothing improper in the Administrator's approach.
The statutory term "adequately competitive conditions" is not
necessarily as narrow as the petitioner suggests. This is not an
anti-trust case, and Dr. Craker does not point to any authority
suggesting that anti-trust laws must guide the "adequacy of
competition" inquiry or that price considerations must not. That
the current regime may not be the most competitive situation
possible does not render it "inadequate."
b. Adequate and Uninterrupted Supply9
In finding that Dr. Craker failed to demonstrate that the
current supply of marijuana was not adequate and uninterrupted, the
9
Dr. Craker does not renew on appeal his argument that the
current marijuana supply is lacking in quality.
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Administrator observed that there were over 1000 kilograms of
marijuana in NIDA possession, an amount which far exceeds present
research demands and "any foreseeable" future demand. Id. at 2119.
Dr. Craker does not dispute this finding, or that the current
amount is more than ninety times the amount he proposes to supply.
Id. Instead, he argues that the adequacy of supply must not be
measured against NIDA-approved research, but by whether the supply
is adequate to supply projects approved by the FDA. But even if we
were to accept his premise -- which we don't -- Dr. Craker fails to
demonstrate that the supply is inadequate for those needs, either.
He merely states that certain projects were rejected as "not bona-
fide" by NIDA, a claim which does not address the adequacy of
supply. The fact that Dr. Craker disagrees with the method by
which marijuana research is approved does not undermine the
substantial evidence that supports the Administrator's conclusion
or render that conclusion arbitrary or capricious.
IV. CONCLUSION
Because the Administrator's interpretation of the CSA is
permissible and her findings are reasonable and supported by the
evidence, the petition for review is denied.
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