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Petitioners Sue Sisley, Scottsdale Research Institute, Field to Healed, and Three Veterans

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Petitioners Sue Sisley, Scottsdale Research Institute, Field to Healed, and Three Veterans

Take action to remove Cannabis as a Schedule 1 Narcotic. Petitioners Sue Sisley, Scottsdale Research Institute, Field to Healed, and three veterans – Lorenzo Sullivan, Kendric Speagle, and Gary Hess

Case: 20-71433, 11/30/2020, ID: 11908568, DktEntry: 37, Page 1 of 77

No. 20-71433

           __________________________________

IN THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT __________________________________

SUSAN SISLEY, et al., Petitioners,

v.
U.S. DRUG ENFORCEMENT ADMINISTRATION, et al.,

Respondents. __________________________________

On Petition for Review From An Order of the U.S. Drug Enforcement

Administration __________________________________

ANSWERING BRIEF FOR THE FEDERAL RESPONDENTS

__________________________________
JEFFREY BOSSERT CLARK

Acting Assistant Attorney General

MARK B. STERN DANIEL AGUILAR Attorneys, Appellate Staff
Civil Division, Room 7266 U.S. Department of Justice
950 Pennsylvania Avenue, NW Washington, DC 20530-0001 (202) 514-5432

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TABLE OF CONTENTS

Page

STATEMENT OF JURISDICTION ……………………………………………………………………… 1 INTRODUCTION…………………………………………………………………………………………………. 1 STATEMENT OF THE ISSUES …………………………………………………………………………… 2 PERTINENT STATUTES AND REGULATIONS………………………………………………. 2 STATEMENT OF THE CASE ……………………………………………………………………………… 3

  1. STATUTORY AND REGULATORY FRAMEWORK …………………………………………………. 3
  2. FACTUAL AND PROCEDURAL BACKGROUND …………………………………………………… 5
    1. The Zyszkiewicz Petition For DEA Rulemaking …………………………………….. 5
    2. Zyszkiewicz’s Attempts To Seek Judicial Review …………………………………… 11
    3. This Petition For Judicial Review ………………………………………………………….. 12

SUMMARY OF ARGUMENT …………………………………………………………………………….. 12 STANDARD OF REVIEW ………………………………………………………………………………….. 14 ARGUMENT ……………………………………………………………………………………………………….. 15 I. THE COURT SHOULD DISMISS THE PETITION FOR REVIEW …………………………… 15

  1. Petitioners Lack Standing Because Their Claims Rest On
    A Generalized Grievance And the Rights Of Third Parties……………………. 15
  2. Petitioners Have Not Exhausted Their Administrative
    Remedies, And May Not Challenge The Denial Of
    Another Person’s Petition For Rulemaking……………………………………………. 22

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II. DEA APPROPRIATELY DENIED THE ZYSZKIEWICZ PETITION
FOR RULEMAKING…………………………………………………………………………………………. 28

  1. DEA’s Denial Was Reasonable And Appropriate………………………………….. 28
  2. Petitioners’ Nondelegation Argument Is Insubstantial…………………………… 39

CONCLUSION ……………………………………………………………………………………………………. 45 STATEMENT OF RELATED CASES
CERTIFICATE OF COMPLIANCE

ADDENDUM

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TABLE OF AUTHORITIES
Cases: Page(s)

Agua Caliente Tribe of Cupeño Indians of Pala Reservation v. Sweeney,
932 F.3d 1207 (9th Cir. 2019)…………………………………………………………………………22, 23

Alliance for Cannabis Therapeutics v. DEA,
930 F.2d 936 (D.C. Cir. 1991) ……………………………………………………………………….. 14, 34

Alliance for Cannabis Therapeutics v. DEA,

15 F.3d 1131 (D.C. Cir. 1994) …………………………………………………………………………….. 35

Americans for Safe Access v. DEA,
706 F.3d 438 (D.C. Cir. 2013) …………………………………………………………………4, 5, 14, 35

Arakaki v. Lingle,
477 F.3d 1048 (9th Cir. 2007)……………………………………………………………………………… 14

Barnhart v. Walton,

535 U.S. 212 (2002)…………………………………………………………………………………………….. 35

Bonds v. Tandy,
457 F.3d 409 (5th Cir. 2006)……………………………………………………………………………….. 28

Cabaccang v. U.S. Citizenship and Immigration Services,
627 F.3d 1313 (9th Cir. 2010)……………………………………………………………………………… 23

Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc. ̧

467 U.S. 837 (1984)………………………………………………………………………. 14, 34, 35, 37, 38

Darby v. Cisneros,
509 U.S. 137 (1993)……………………………………………………………………………………….. 26, 27

Elgin v. Department of Treasury,
567 U.S. 1 (2012)………………………………………………………………………………………………… 26

Ex parte Levitt,
302 U.S. 633 (1937)…………………………………………………………………………………………….. 17

Fairchild v. Hughes,
258 U.S. 126 (1922)…………………………………………………………………………………………….. 17

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Garfias-Rodriguez v. Holder,
702 F.3d 504 (9th Cir. 2012) (en banc) ……………………………………………………………….. 37

Getty Oil Co. v. Andrus,
607 F.2d 253 (9th Cir. 1979)……………………………………………………………………………….. 30

Gill v. Whitford,
138 S. Ct. 1916 (2018) …………………………………………………………………………………… 13, 19

Grinspoon v. DEA,
828 F.2d 881 (1st Cir. 1987) ……………………………………………………………………..14, 33, 34

Hemp Indus. Ass’n v. DEA,
357 F.3d 1012 (9th Cir. 2004)…………………………………………………………………………35, 38

Hollingsworth v. Perry,
570 U.S. 693 (2013)…………………………………………………………………………………………….. 21

Lance v. Coffman,
549 U.S. 437 (2007)…………………………………………………………………………………………….. 18

John Doe, Inc. v. DEA,
484 F.3d 561 (D.C. Cir. 2007) …………………………………………………………………………….. 24

Krumm v. DEA,
739 F. App’x 655 (D.C. Cir. 2018) (per curiam) ………………………………………………….. 35

Leorna v. U.S. Department of State,
105 F.3d 548 (9th Cir. 1997)……………………………………………………………………………….. 14

Lexmark Int’l, Inc. v. Static Control Components, Inc.,
572 U.S. 118 (2014)…………………………………………………………………………………………….. 16

Lujan v. Defenders of Wildlife,
504 U.S. 555 (1992)……………………………………………………………………………. 15, 16, 17, 18

Massachusetts v. EPA,
549 U.S. 497 (2007)…………………………………………………………………………………………….. 29

Mills v. United States,
742 F.3d 400 (9th Cir. 2014)……………………………………………………………………………….. 20

Motor Vehicle Mfrs. Ass’n ofU.S., Inc. v. State Farm Mut. Auto. Ins. Co.,
463 U.S. 29 (1983)………………………………………………………………………………………………. 29

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Gonzales v. Oregon,
546 U.S. 243 (2006)…………………………………………………………………………………………….. 36

Pacific Maritime Ass’n v. NLRB,
827 F.3d 1203 (9th Cir. 2016)……………………………………………………………………………… 27

PDK Laboratories Inc. v. DEA,
362 F.3d 786 (D.C. Cir. 2004) …………………………………………………………………………….. 28

Schlesinger v. Reservists Comm. to Stop the War,
418 U.S. 208 (1974)…………………………………………………………………………………………….. 17

Smelt v. County of Orange,
447 F.3d 673 (9th Cir. 2006)………………………………………………………………………….. 19, 20

Steve G. v. Monterey Peninsula Unified School Dist.,
933 F.3d 1096 (9th Cir. 2019)……………………………………………………………………………… 24

Thunder Basin Coal Co. v. Reich,
510 U.S. 200 (1994)…………………………………………………………………………………………….. 25

Touby v. United States,

500 U.S. 160 (1991)……………………………………………………………………………………….. 40, 41

United Sates v. L.A. Tucker Truck Lines, Inc.,
344 U.S. 33 (1952)………………………………………………………………………………………………. 23

United States v. Kelly,
874 F.3d 1037 (9th Cir. 2017)……………………………………………………….. 14, 35, 38, 41, 44

United States v. Richardson,
418 U.S. 166 (1974)…………………………………………………………………………………………….. 17

Warth v. Seldin,
422 U.S. 490 (1975)……………………………………………………………………………………….. 16, 21

Washington v. Barr,
925 F.3d 109 (2d Cir. 2019) ……………………………………………………………….. 13, 24, 25, 28 cert. denied, — S. Ct. —, 2020 WL 6037234 (Oct. 13, 2020) …………………………….. 13, 24

Whitman v. American Trucking Ass’ns,
531 U.S. 457 (2001)…………………………………………………………………………………..39, 40, 43

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Whitmore v. Arkansas,
495 U.S. 149 (1990)…………………………………………………………………………………………….. 16

Woodford v. Ngo,
548 U.S. 81 (2006)…………………………………………………………………………………………. 22, 23

Yakus v. United States,
321 U.S. 414 (1944)……………………………………………………………………………………….. 40, 43

Zyszkiewicz v. Barr,
2020 WL 3572908 (D.D.C. June 30, 2020)…………………………………………………….. 11, 21

Constitution, Treaties, and Statutes:

U.S. Const. art. I, § 1……………………………………………………………………………………………… 39

Single Convention on Narcotic Drugs, 18 U.S.T. 1407 (1967) ……………………………….. 43

Pub. L. No. 91-513, title II, § 202(c) (schedule I(c)(10)),
84 Stat. 1242 (1970) ………………………………………………………………………………………… 3, 40

Pub. L. No. 89-329,
98 Stat. 280 (1984) ……………………………………………………………………………………………… 33

5 U.S.C. § 706(2)(A) ………………………………………………………………………………………………. 15 16 U.S.C. § 1540(g)………………………………………………………………………………………………… 17 21 U.S.C. § 355(b)(1)……………………………………………………………………………………………… 33 21 U.S.C. §§ 801-971……………………………………………………………………………………………….. 3 21 U.S.C. § 811…………………………………………………………………………………………………… 5, 24 21 U.S.C. § 811(a)………………………………………………………………….1, 3, 4, 13, 22, 28, 30, 42 21 U.S.C. § 811(d)…………………………………………………………………………………………….. 41, 44 21 U.S.C. § 811(d)(1)…………………………………………………………………………………………42, 43 21 U.S.C. § 811(d)(2)……………………………………………………………………………………………… 42 21 U.S.C. § 811(h)………………………………………………………………………………………………….. 41 21 U.S.C. § 812………………………………………………………………………………………………………… 5

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21 U.S.C. § 812(a)-(b)………………………………………………………………………………………………. 3 21 U.S.C. § 812(b)……………………………………………………………………………. 14, 41, 42, 43, 44 21 U.S.C. § 812(b)(1)…………………………………………………………………………. 3, 34, 37, 41, 44 21 U.S.C. § 812(b)(1)(B)……………………………………………………………………………….14, 29, 35 21 U.S.C. § 812(b)(1)(B)-(C)…………………………………………………………………………………… 34 21 U.S.C. § 812(c) …………………………………………………………………………………………………… 3, 21 U.S.C. § 812(c), schedule I(b)(10) ……………………………………………………………………… 33 21 U.S.C. § 812(c), schedule I(c)(10)…………………………………………………………….37, 38, 40 21 U.S.C. § 823(a) ………………………………………………………………………………………………….. 20 21 U.S.C. §§ 823-824……………………………………………………………………………………………… 36 21 U.S.C. § 877……………………………………………………………………………………. 1, 5, 11, 20, 25

Regulations:

21 C.F.R. § 1308.11(e)(3) ……………………………………………………………………………………….. 33 21 C.F.R. § 1308.12(f)(2) ……………………………………………………………………………………….. 38 21 C.F.R. § 1308.13(g)(1)……………………………………………………………………………………….. 38 28 C.F.R. § 0.100 …………………………………………………………………………………………………….. 3 57 Fed. Reg. 10499 (Mar. 26, 1992) ……………………………………………………………….4, 30, 35 84 Fed. Reg. 44920 (Aug. 27, 2019) ……………………………………………………………………….. 20 84 Fed. Reg. 54926 (Oct. 11, 2019)………………………………………………………………………… 20

Other Authorities:

Pet. for Declaratory Judgment, Writ of Mandamus, and Review,
Zyszkiewicz v. Barr, No. 20-1599 (D.D.C. May 29, 2020)………………………………………. 11

Mot. to Dismiss, Zyszkiewicz v. DEA,
No. 20-1308 (D.C. Cir. Oct. 5, 2020) ………………………………………………………………….. 11

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Opp.,
Zyszkiewicz v. DEA, No. 20-1308 (D.C. Cir. Oct. 25, 2020)……………………………. 12, 21

Zyszkiewicz v. Barr, No. 20-1599 (D.D.C.)……………………………………………………………….. 11 Zyszkiewicz v. Barr, No. 20-5213 (D.C. Cir.)……………………………………………………….. 11, 21 Zyszkiewicz v. DEA, No. 20-1308 (D.C. Cir.)……………………………………………………..11, 21

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STATEMENT OF JURISDICTION

On April 22, 2020, the U.S. Drug Enforcement Administration (DEA) denied a request by two individuals to initiate a rulemaking under 21 U.S.C. § 811(a). ER2-5. Petitioners in this case did not participate in that request for rulemaking and have not asked DEA to initiate rulemaking. Instead, petitioners ask this Court to review DEA’s denial of a rulemaking petition filed by other people, citing 21 U.S.C. § 877. For the reasons explained infra, pp. 15-21, this Court lacks jurisdiction over the petition.

INTRODUCTION

This case concerns marijuana’s status as a schedule I substance under the Controlled Substance Act. Under the Act, any citizen may petition DEA to move a schedule I substance to a different schedule, or to remove it from the schedules of controlled substances entirely. If DEA denies that petition, or issues an adverse order, the petitioner may seek judicial review.

In January 2020, two individuals—Stephen Zyszkiewicz and Jeramy Bowers— petitioned DEA to reschedule marijuana in a one-page petition. DEA denied that request. Zyszkiewicz has filed two separate lawsuits in the federal courts for the District of Columbia seeking review of DEA’s decision. Neither those lawsuits are before this Court.

Petitioners here seek review of the denial of the Zyszkiewicz petition even though they were not involved in that request and have not asked DEA to reschedule

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marijuana. Instead, petitioners ask this Court to reverse DEA’s decision based on arguments that were never presented to the agency. If petitioners think marijuana should be rescheduled, they may petition DEA to do so and present their contentions to the agency. And if their petition is denied, they can then pursue those arguments in this Court. They may not, however, present an array of arguments in this Court that formed no part of a request for rulemaking filed by other people, not parties here.

Assuming that the petition is properly before the Court, its arguments fail on the merits. Petitioners contend that DEA’s decision to retain marijuana on schedule I is arbitrary and capricious and that Congress has unconstitutionally granted DEA legislative authority. Those arguments are contrary to settled precedent and should be rejected if the Court were to reach them.

STATEMENT OF THE ISSUES

1. Whether petitioners have standing to challenge DEA’s denial of another person’s petition to reschedule a controlled substance.

2. Whether petitioners have failed to exhaust their administrative remedies because they have not asked DEA to reschedule marijuana.

3. On the merits, whether DEA’s denial of the rescheduling petition violated the nondelegation principle or was arbitrary and capricious.

PERTINENT STATUTES AND REGULATIONS

Pertinent statutes and regulations appear in the addendum to this brief. 2

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STATEMENT OF THE CASE I. STATUTORY AND REGULATORY FRAMEWORK

The Controlled Substances Act, 21 U.S.C. §§ 801-971, establishes a comprehensive federal scheme to regulate the manufacture and distribution of controlled substances. The Act divides controlled substances into five schedules, based on their potential for abuse, medical uses, and risk of physical or psychological dependence. Id. § 812(a)-(b). Generally speaking, a schedule I substance has no accepted medical use and a high risk for abuse, while schedule II-V substances have accepted medical uses and decreasing risk of abuse and dependence. Id. Congress initially designated scores of substances under the schedules, id. § 812(c), and authorized the Attorney General to add, remove, or reschedule substances through rulemaking, id. § 811(a). The Attorney General, in turn, delegated this authority to the DEA Administrator. 28 C.F.R. § 0.100.1

Congress initially designated marijuana as a schedule I substance. See Pub. L. No. 91-513, title II, § 202(c) (schedule I(c)(10)), 84 Stat. 1242, 1249 (1970). Schedule I substances have “a high potential for abuse,” have “no currently accepted medical use in treatment in the United States,” and lack “accepted safety for use * * * under medical supervision.” 21 U.S.C. § 812(b)(1). In a 1992 rulemaking, DEA set forth

1 For simplicity, this brief refers to authority exercised by DEA whenever the Controlled Substances Act grants authority to the Attorney General and the Attorney General has in turn delegated that authority to the DEA Administrator.

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five factors to consider in determining whether a substance has a currently accepted medical use:

1. Whether the substance’s chemistry is known and reproducible;
2. Whether there are adequate safety studies;
3. Whether there are adequate and well-controlled studies proving efficacy; 4. Whether the substance is accepted by qualified experts; and
5. Whether the scientific evidence is widely available.

57 Fed. Reg. 10499, 10506 (Mar. 26, 1992). Under that rulemaking, DEA has required all five factors to be satisfied in order for a substance to “be deemed to have a currently accepted medical use.” Americans for Safe Access v. DEA, 706 F.3d 438, 450 (D.C. Cir. 2013).

DEA can, if the evidence warrants, transfer a substance from one schedule to another by rulemaking. 21 U.S.C. § 811(a)(1). Such rulemaking proceedings “may be initiated” by the DEA Administrator “(1) on his own motion, (2) at the request of the Secretary [of Health and Human Services], or (3) on the petition of any interested party.” Id. § 811(a). “[B]efore initiating [rulemaking] proceedings,” DEA gathers all “necessary data” and obtains a written “scientific and medical evaluation” and a recommendation from the Secretary of Health and Human Services (HHS) as to whether a substance should be rescheduled. Id. § 811(b). The Secretary’s recommendations on scientific and medical matters “shall be binding.” Id. If DEA determines that substantial evidence supports moving the substance to a different schedule, then it “shall initiate proceedings for control or removal, as the case may be.” Id.

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“[A]ny person aggrieved by a final decision” regarding rescheduling may seek judicial review in the D.C. Circuit or the circuit in which their principal place of business is located. 21 U.S.C. § 877. Thus, a person who petitions DEA to reschedule a substance may seek judicial review if the Administrator denies that petition. Americans for Safe Access, 706 F.3d at 442.
II. FACTUAL AND PROCEDURAL BACKGROUND

A. The Zyszkiewicz Petition For DEA Rulemaking

In January 2020, Stephen Zyszkiewicz and Jeramy Bowers filed a one-page, handwritten petition “to remove or reschedule cannabis (marijuana) in all its forms” under “21 USCS 811, 812.” ER1. Zyszkiewicz and Bowers stated that “the current situation of cannabis in Schedule I [is] completely untenable” because “[h]alf the states allow for medical use and the FDA allows CBD and THC pharmaceuticals as well as IND compassionate use.” ER1. Zyszkiewicz and Bowers offered no other argument for rescheduling marijuana, and provided no medical evidence regarding its use.

DEA responded in an April 2020 letter. ER2-5. DEA denied the petition for rulemaking, explaining that DEA had conducted an extensive analysis of the medical and scientific literature related to marijuana potential use in treatment in response to a different petition for rulemaking in 2016. ER2, ER7. As part of that 2016 analysis, the DEA Administrator had referred a petition to reschedule marijuana to the Secretary of HHS to obtain her findings and opinions on scientific and medical

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matters, in accordance with 21 U.S.C. § 811(b). ER8. The Secretary, in turn, referred the petition to the Food and Drug Administration (FDA) to evaluate the scientific and medical data, assess whether marijuana has a currently accepted medical use, and provide a scheduling recommendation for marijuana. ER31-32. FDA conducted its scientific review, ER31-57, and referred the petition back to the Secretary, who issued a series of factual findings concerning marijuana’s chemistry, its physiological effects, its potential medical use, and its potential for abuse, ER8-31. The Secretary concluded that “[m]arijuana does not meet any of the elements for having a ‘currently accepted medical use.’” ER26. The Secretary then referred the petition back to DEA, which issued additional findings, ER58-85, and the DEA Administrator ultimately concluded that marijuana should remain a schedule I substance, ER7. For ease of reference, this brief generally refers to the findings and conclusions of this collaborative process as being DEA’s.

In concluding that marijuana does not have a currently accepted medical use, DEA applied the five-factor test set out in the governing regulations, and concluded that none of the factors were met. ER26, 75-76.

1. The substance’s chemistry must be well known and reproducible. DEA explained that marijuana samples come from a variety of cultivated strains, which can have “very different chemical constituents.” ER11. In particular, each marijuana plant will possess approximately 100 cannabinoid chemical compounds, but the concentration of these compounds will vary across different strains. ER11, 17. This variation in

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marijuana’s chemical profile “complicate[s] the interpretation of clinical data using marijuana.” ER17. For example, a 1-gram marijuana cigarette might have as little as 3 milligrams of THC (tetrahydrocannabinol, marijuana’s principal psychoactive chemical) or as much as 150 milligrams of THC, thus making it difficult to evaluate studies that test the efficacy of smoking marijuana. ER17-18. In considering whether to reschedule marijuana, DEA concluded that it was not possible to reproduce a consistent, standardized dose for all of marijuana’s potential strains. ER19 (noting that this might be possible for a particular marijuana strain if it was consistently cultivated under strict conditions).

2. There must be adequate and well-controlled studies proving efficacy. DEA reviewed the abstracts of 566 scientific articles, which contained terms indicating that they might be an adequate and well-controlled study of marijuana’s efficacy. ER34 & n.30. Of these, only 11 studies were determined to be “randomized, double-blind, placebo- controlled clinical studies conducted with marijuana to assess marijuana’s efficacy in any therapeutic indication.” ER34; see also ER35 (explaining why other studies did not meet this criteria). DEA concluded that these 11 studies did not demonstrate efficacy, but were best understood as “[p]roof of concept studies” that can “provide preliminary evidence on a proposed hypothesis involving a drug’s effect.” ER20.

Five studies showed “positive results” for using marijuana as an analgesic for chronic neuropathic pain. ER41. But the subjects in these studies continued to use their preexisting analgesic drugs in addition to marijuana, making it difficult to

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conclude if marijuana had effective analgesic properties on its own. ER36-39. The subjects also suffered from many different kinds of neuropathic pain, “making it difficult to identify whether a specific set of symptoms might be more responsive to the effects of marijuana.” ER41. Some subjects also had to withdraw from the studies based on adverse effects from marijuana. ER37 (one subject “developed an intractable smoking-related cough” while the only “marijuana-naïve” subject “experienced an incident of acute cannabis-induced psychosis”).

Two studies showed “positive results” for using both marijuana and dronabinol (synthetic THC) to increase appetite and weight gain in HIV-positive patients. ER41. However, all of the subjects in these studies were chronic marijuana users, and the doses of THC given to the subjects were several times greater than the typical doses for appetite stimulation. ER41. Thus, the studies did not address whether patients with little prior exposure to marijuana would be able to tolerate the high THC levels used in these studies, or whether marijuana would still show positive results with limited adverse effects for such patients. ER41.

One study showed some “positive results” for treating spasticity in multiple sclerosis patients with smoked marijuana. ER42. However, the patients continued to use their preexisting medication regime, and it was difficult to conclude marijuana’s efficacy as a stand-alone treatment. ER42. Moreover, it was “concerning” that five out of thirty subjects withdrew from the study “because they were unable to tolerate the psychiatric [adverse events] induced by marijuana.” ER40, 42.

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While one study showed “positive results” for treating asthma patients with smoked marijuana, there was an obvious concern about administering “harmful and irritating substances” into the lungs of asthma patients by instructing them to smoke. ER42. Additionally, the patients smoked marijuana while they were at rest and not suffering bronchospasms, leaving it uncertain whether marijuana was effective at treating asthma attacks. ER42.

Two studies had shown “positive results” for treating glaucoma with marijuana, but “the effect is short-lasting, requires a high dose, and is associated with many [adverse events]. Thus, the potential harmful effects may outweigh any modest benefit of marijuana for this condition.” ER42.

DEA noted a number of other complicating factors in these studies that limited their usefulness in determining marijuana’s efficacy as a medical treatment. The treatment groups in these studies were small (ranging from 10 to 25 subjects) and were “statistically inadequate to support a showing of safety or efficacy.” ER42. No study lasted longer than five days, although the purpose of the studies was to determine to demonstrate marijuana’s efficacy for treating chronic medical conditions that could last a lifetime. ER43. And, as a general matter, it was “not recommended” to prescribe smoking as a medical treatment, because this would necessarily put smoke “into the lungs of individuals with a disease state * * * when their bodies may be physically compromised.” ER43. Finally, all of these studies had an inherent difficulty in ensuring that the subjects were truly “blind,” i.e., that they did not know if

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they were receiving marijuana or a placebo. ER43. Because marijuana has a “rapid onset of psychoactive effects,” test subjects will likely know if they are receiving marijuana instead of a placebo, which could lead to an expectation bias that changes the subjects’ “perceived responsivity to the therapeutic outcome.” ER43.

3. DEA then determined that none of the remaining three factors supported a finding that marijuana had a currently accepted medical use. DEA concluded that there were no adequate safety studies for marijuana, because in order to determine whether marijuana could be safe for treatment, there needs to be a “risk-benefit analysis” for whether marijuana’s side effects are outweighed by its “potential benefits for a particular indication.” ER20. Because DEA concluded that marijuana has not been shown to be an effective treatment for any medical condition, it similarly could not be shown to be safe for treating such conditions. ER20.

Likewise, given the absence of any adequate, well-controlled studies, DEA concluded that there was “no evidence that there is a consensus among qualified experts that marijuana is safe and effective for use in treating a specific, recognized disorder.” ER20.

Finally, DEA found that there was not widely available scientific evidence of a cultivated marijuana strain “that could produce standardized and reproducible doses.” ER21.

Accordingly, DEA found that the current scientific evidence “has not progressed to the point where marijuana is considered to have a ‘currently accepted

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medical use’ or a ‘currently accepted medical use with severe restrictions,’ ” ER21, and it therefore must remain classified as a schedule I substance, ER7.2

B. Zyszkiewicz’s Attempts to Seek Judicial Review

After receiving DEA’s denial, Zyszkiewicz sought judicial review. He first filed suit in the District Court for the District of Columbia seeking to compel DEA to reschedule marijuana. Pet. for Declaratory Judgment, Writ of Mandamus, and Review at 2-3, Zyszkiewicz v. Barr, No. 20-1599 (D.D.C. May 29, 2020). The district court sua sponte dismissed Zyszkiewicz’s lawsuit, noting that he could have—but had not— sought judicial review of DEA’s denial in the D.C. Circuit under 21 U.S.C. § 877. Zyszkiewicz v. Barr, 2020 WL 3572908, at *1 (D.D.C. June 30, 2020). Zyszkiewicz appealed from that dismissal, and that appeal is pending in the D.C. Circuit. Zyszkiewicz v. Barr, No. 20-5213 (D.C. Cir.).

In August 2020, after appealing the adverse district court order, Zyszkiewicz separately sought judicial review of DEA’s denial under 21 U.S.C. § 877 by filing a petition for judicial review in the D.C. Circuit. Zyszkiewicz v. DEA, No. 20-1308 (D.C. Cir.). DEA moved to dismiss that petition as untimely because it was filed outside the 30-day time limit prescribed by § 877. Mot. to Dismiss, Zyszkiewicz v. DEA, No. 20-

2 DEA also found that marijuana poses health risks from acute use, including impaired psychomotor performance, dysphoria, and prolonged psychological distress, including prolonged anxiety reactions. ER23. DEA further found that marijuana has a widespread potential for abuse through non- medical use. ER62, 66, 80.

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1308 (D.C. Cir. Oct. 5, 2020). Zyszkiewicz did not contest that his petition was untimely, Opp. at 1-2, Zyszkiewicz v. DEA, No. 20-1308 (D.C. Cir. Oct. 25, 2020), and the D.C. Circuit has not yet acted on the petition.3

C. This Petition For Judicial Review

Petitioners are Suzanne Sisley, Scottsdale Research Institute LLC, Battlefield Foundation, Lorenzo Sullivan, Kendrick Speagle, and Gary Hess. Their petition in this Court seeks “review of [DEA’s] final determination denying Stephen Zyszkiewicz’s January 3, 2020 petition to reschedule.” Pet. at 6, Dkt. 1-6. Because none of these petitioners were a signatory to the Zyszkiewicz petition or had otherwise asked DEA to reschedule marijuana, DEA moved to dismiss the case because petitioners had failed to exhaust their administrative remedies. Dkt. 11. This Court entered an order that denied dismissal “without prejudice to renewing the arguments in the answering brief.” Dkt. 17.

SUMMARY OF ARGUMENT
I. A. Petitioners have not filed a petition for rulemaking with DEA and have

not had a petition denied. Their petition must therefore be dismissed at the threshold. Petitioners’ contention that they were injured by the denial of the Zyszkiewicz petition for rulemaking states the kind of “generalized grievance against

3 In his opposition, Zyszkiewicz stated that he has filed a new petition to reschedule marijuana with DEA, and that DEA has not yet acted on that subsequent petition. Opp. at 2, 6-7, Zyszkiewicz v. DEA, No. 20-1308 (D.C. Cir. Oct. 25, 2020).

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governmental conduct” that is insufficient to support standing. Gill v. Whitford, 138 S. Ct. 1916, 1930 (2018). Nor can petitioners assert third-party standing based on any harm to Zyszkiewicz or Bowers. Those third-parties are fully capable of defending their interests, and Zyszkiewicz has challenged the denial of his petition for rulemaking.

B. For related reasons, the petition should be dismissed because petitioners have failed to exhaust their administrative remedies. This Court has consistently required parties to exhaust their applicable administrative remedies before seeking judicial review, and those precedents apply with full force to the administrative remedies available under the Controlled Substances Act. See Washington v. Barr, 925 F.3d 109, 115-18 (2d Cir. 2019) (holding that plaintiffs may not sue over marijuana’s placement on schedule I without first filing a rescheduling petition under 21 U.S.C.
§ 811(a)), cert. denied, — S. Ct. —, 2020 WL 6037234 (Oct. 13, 2020). The importance of that requirement is particularly evident here, where petitioners attack DEA’s decision on grounds never presented to the agency.

II. A. If this petition were properly before the Court, its arguments should be rejected on the merits. DEA acted reasonably in denying a one-page petition to reschedule marijuana which presented no scientific evidence as to marijuana’s safety or efficacy as a medical treatment and merely argued that rescheduling was warranted because many states had enacted medical marijuana laws. In denying the petition, DEA examined whether marijuana has a “currently accepted medical use in treatment

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in the United States.” 21 U.S.C. § 812(b)(1)(B). That statutory phrase is ambiguous, see Grinspoon v. DEA, 828 F.2d 881, 885 (1st Cir. 1987); Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936, 939 (D.C. Cir. 1991), and DEA has construed its meaning by promulgating a five-factor test that examines whether a substance is safe and effective way to treat specific medical conditions. That multi-factor test has been explicitly and repeatedly endorsed by the D.C. Circuit, see e.g., Americans for Safe Access v. DEA, 706 F.3d 438, 449 (D.C. Cir. 2013), and it a reasonable exercise of authority to construe an ambiguous statutory phrase. Under the framework laid out in Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc. ̧467 U.S. 837, 842-43 (1984), DEA’s denial was a proper application of that reasonable interpretation.

B. Petitioners wrongly claim that DEA’s denial constituted an impermissible exercise of legislative power. Congress placed marijuana on schedule I by statute, and DEA here denied rescheduling based on the statutory factors identified in 21 U.S.C.
§ 812(b), which this Court has explained do not offend the nondelegation doctrine. See United States v. Kelly, 874 F.3d 1037, 1047-48 (9th Cir. 2017).

STANDARD OF REVIEW

Whether petitioners have standing is a legal issue determined de novo. Arakaki v. Lingle, 477 F.3d 1048, 1056 (9th Cir. 2007). The Court also determines de novo whether petitioners have exhausted their administrative remedies. Leorna v. U.S. Department of State, 105 F.3d 548, 550 (9th Cir. 1997). The Court reviews DEA’s decision not to initiate rulemaking proceedings to determine whether it was arbitrary,

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capricious, and abuse of discretion, or otherwise not in accordance with law. 5 U.S.C. § 706(2)(A).

ARGUMENT
I. THE COURT SHOULD DISMISS THE PETITION FOR REVIEW

Stephen Zyszkiewicz and Jeramy Bowers petitioned DEA to institute rulemaking about marijuana’s designation as a schedule I controlled substance, and DEA declined to do so. Petitioners seek judicial review of DEA’s decision. The fundamental problem with petitioners’ suit is that neither Zyszkiewicz nor Bowers is a party to it. Petitioners do not seek relief for any action that DEA has taken against them—instead, they assert the rights of others and contend that DEA’s decision must be set aside based on legal theories that neither Zyszkiewicz nor Bowers presented to the agency. The Court should dismiss petitioners’ suit for two related reasons. First, petitioners lack standing to challenge DEA’s denial of someone else’s rulemaking petition. Second, petitioners have failed to exhaust their administrative remedies because they have never asked DEA to institute rulemaking proceedings themselves.

A. Petitioners Lack Standing Because Their Claims Rest On A Generalized Grievance And The Rights Of Third Parties

In order to have standing to bring suit, a plaintiff must establish that she has a concrete and particularized injury. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992). A plaintiff fails to satisfy that requirement if she asserts only a “generalized grievance” that is “shared in substantially equal measure by all or a large class of

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