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`Case 3:20-cv-03703-RS Document 35 Filed 10/29/20 Page 1 of 31
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`
`
`Emily Johnson Henn (CA Bar No. 269482)
`COVINGTON & BURLING LLP
`3000 El Camino Real
`5 Palo Alto Square
`Palo Alto, California 94306-2112
`Telephone: (650) 632-4700
`Fax: (650) 632-4800
`Email: ehenn@cov.com
`
`Bradley K. Ervin (pro hac vice)
`Virginia A. Williamson (pro hac vice)
`COVINGTON & BURLING LLP
`One CityCenter
`850 10th Street NW
`Washington, DC 20001-4956
`Telephone: (202) 662-6000
`Fax: (202) 662-6291
`Emails: bervin@cov.com
`vwilliamson@cov.com
`
`Attorneys for Intervenor-Defendant
`ELANCO ANIMAL HEALTH
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
`
`Civil Case No. 3:20-cv-03703-JCS
`
`
`ELANCO ANIMAL HEALTH’S
`MOTION TO DISMISS FOR
`LACK OF ARTICLE III
`STANDING AND FAILURE TO
`EXHAUST ADMINISTRATIVE
`REMEDIES
`
`Date: January 14, 2021
`Time: 1:30 p.m.
`Dept: San Francisco, Courtroom 3
`Judge: Hon. Richard Seeborg
`
`
`ANIMAL LEGAL DEFENSE FUND, FOOD &
`WATER WATCH, and FOOD ANIMAL
`CONCERNS TRUST,
`
`
`
` Plaintiffs,
`
`
`
`
`v.
`
`ALEX AZAR, Secretary of the United States
`Department of Health and Human Services;
`STEPHEN HAHN, Commissioner of the United
`States Food and Drug Administration; and
`UNITED STATES FOOD AND DRUG
`ADMINISTRATION,
`
`
`
` Defendants,
`
`and
`
`ELANCO ANIMAL HEALTH,
`
`
`
` Intervenor-Defendant.
`
`
`
`
`
`
`ELANCO’S MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`

`

`Case 3:20-cv-03703-RS Document 35 Filed 10/29/20 Page 2 of 31
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`NOTICE OF MOTION...................................................................................................................1
`
`POINTS AND AUTHORITIES .....................................................................................................1
`
`INTRODUCTION AND STATEMENT OF ISSUES ...................................................................1
`
`STATEMENT OF FACTS .............................................................................................................3
`
`ARGUMENT ..................................................................................................................................7
`
`I.
`
`THE COURT SHOULD DISMISS PLAINTIFFS’ CLAIMS FOR LACK OF
`ARTICLE III STANDING. ................................................................................................7
`
`A.
`
`B.
`
`C.
`
`Plaintiffs Have Not Plausibly Alleged Cognizable Injuries In Fact. ......................8
`
`Plaintiffs Have Not Shown That Their Alleged Injuries Are Fairly Traceable To
`FDA’s Alleged NEPA Violations. ........................................................................13
`
`Plaintiffs Have Not Shown That Their Alleged Injuries Are Likely To Be
`Redressed By Relief From This Court..................................................................15
`
`II.
`
`THE COURT SHOULD DISMISS, OR IN THE ALTERNATIVE, STAY THIS SUIT
`DUE TO PLAINTIFFS’ FAILURE TO EXHAUST MANDATORY
`ADMINISTRATIVE REMEDIES. ..................................................................................16
`
`A.
`
`B.
`
`C.
`
`FDA Regulations And The APA Require Exhaustion Of The Agency’s
`Mandatory Citizen Petition Administrative Remedy. ..........................................17
`
`Plaintiffs’ Claims Should Be Dismissed Because Plaintiffs Have Not Exhausted
`FDA’s Mandatory Administrative Remedy..........................................................18
`
`In The Alternative, A Stay Of Proceedings Is Appropriate To Allow Plaintiffs To
`Exhaust The Mandatory Citizen Petition Remedy. ..............................................22
`
`III.
`
`PLAINTIFFS’ FIRST CLAIM FOR RELIEF SHOULD BE DISMISSED FOR
`FAILURE PROPERLY TO REQUEST RELIEF PURSUANT TO FEDERAL RULES
`OF CIVIL PROCEDURE 8 AND 12(b)(6). .....................................................................22
`
`CONCLUSION.............................................................................................................................24
`
`
`
`i
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`ELANCO’S MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
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`Case 3:20-cv-03703-RS Document 35 Filed 10/29/20 Page 3 of 31
`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Allen v. Wright,
`468 U.S. 737 (1984)................................................................................................................15
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009)............................................................................................................7, 23
`
`Ass’n of Am. Physicians & Surgeons, Inc. v. FDA,
`358 F. App’x 179 (D.C. Cir. 2009).........................................................................................20
`
`Ass’n of Flight Attendants-CWA, AFL-CIO v. Chao,
`493 F.3d 155 (D.C. Cir. 2007) ................................................................................................17
`
`Azizi v. United States,
`No. 15-cv-07456-CAS, 2015 WL 6755193 (C.D. Cal. Nov. 4, 2015) ...................................23
`
`Banks v. Warner,
`No. 94-56732, 1995 WL 465773 (9th Cir. Aug. 7, 1995) ........................................................6
`
`Biotics Research Corp. v. Heckler,
`710 F.2d 1375 (9th Cir. 1983) ................................................................................................19
`
`Bowen v. Massachusetts,
`487 U.S. 879 (1988)................................................................................................................17
`
`Buckingham v. Sec’y of USDA,
`603 F.3d 1073 (9th Cir. 2010) ..........................................................................................17, 21
`
`Cent. & S.W. Servs., Inc. v. EPA,
`220 F.3d 683 (5th Cir. 2000) ..................................................................................................11
`
`Clapper v. Amnesty Int’l USA,
`568 U.S. 398 (2013)........................................................................................................ passim
`
`Clouser v. Espy,
`42 F.3d 1522 (9th Cir. 1994) ..................................................................................................19
`
`Ctr. for Biological Diversity v. U.S. Dep’t of Interior,
`563 F.3d 466 (D.C. Cir. 2009) ................................................................................................13
`
`Ctr. for Biological Diversity v. U.S. Envt’l Protection Agency,
`937 F.3d 533 (5th Cir. 2019) ..................................................................................8, 10, 12, 14
`
`Ctr. for Food Safety v. Hamburg,
`142 F. Supp. 3d 898 (N.D. Cal. 2015) ................................................................................1, 17
`
`ELANCO’S MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`
`ii
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`Ctr. for Food Safety v. Hamburg,
`696 F. App’x 302 (9th Cir. 2017) .............................................................................1, 3, 20, 22
`
`DaimlerChrysler Corp. v. Cuno,
`547 U.S. 332 (2006)..................................................................................................................7
`
`Daniel v. Nat’l Park Serv.,
`891 F.3d 762 (9th Cir. 2018) ..................................................................................................13
`
`Darby v. Cisneros,
`509 U.S. 137 (1993)..........................................................................................................17, 18
`
`In re Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig.,
`590 F. Supp. 2d 1282 (C.D. Cal. 2008) ..................................................................................16
`
`Fed. Power Comm’n v. Colo. Interstate Gas Co.,
`348 U.S. 492 (1955)..........................................................................................................17, 19
`
`Finn v. City of Boulder City,
`No. 14-cv-1834-JAD, 2015 WL 2186497 (D. Nev. May 6, 2015) .........................................23
`
`Fla. Audubon Soc’y v. Bentsen,
`94 F.3d 658 (D.C. Cir. 1996) ..................................................................................................12
`
`Gulf Restoration Network v. Bernhardt,
`No. 18-cv-1674-RBW, 2020 WL 1930470 (D.D.C. April 21, 2020) .....................................15
`
`Havens Realty Corp. v. Coleman,
`455 U.S. 363 (1982)..................................................................................................................7
`
`Hicks v. PGA Tour, Inc.,
`897 F.3d 1109 (9th Cir. 2018) ..................................................................................................5
`
`Hong v. Read,
`No. 19-cv-00086-RGK, 2020 WL 4342539 (C.D. Cal. April 3, 2020) ..................................23
`
`Hunt v. Wash. State Apple Adver. Comm’n,
`432 U.S. 333 (1977)..................................................................................................................7
`
`Levine v. Vilsack,
`587 F.3d 986 (9th Cir. 2009) ..................................................................................................16
`
`Lewis v. Casey,
`518 U.S. 343 (1996)..................................................................................................................7
`
`Lojas v. Washington,
`347 F. App’x 288 (9th Cir. 2009) ...........................................................................................23
`
`Los Angeles v. Lyons,
`461 U.S. 95 (1983)..................................................................................................................11
`ELANCO’S MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`
`iii
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`Lujan v. Defs. of Wildlife,
`504 U.S. 555 (1992)........................................................................................................ passim
`
`Myers v. Bethlehem Shipbuilding Corp.,
`303 U.S. 41 (1938)..................................................................................................................17
`
`N. Air Cargo v. U.S. Postal Serv.,
`674 F.3d 852 (D.C. Cir. 2012) ................................................................................................23
`
`N.Y. Regional Interconnect, Inc. v. FERC,
`634 F.3d 581 (D.C. Cir. 2011) ..................................................................................................9
`
`Nat’l Res. Def. Council v. EPA,
`735 F.3d 873 (9th Cir. 2013) ....................................................................................................9
`
`Nuclear Info. & Res. Serv. v. Nuclear Reg. Comm’n,
`457 F.3d 941 (9th Cir. 2006) ..................................................................................................16
`
`Okanogan Highlands All. v. Williams,
`No. 97-cv-806-JE, 1999 WL 1029106 (D. Or. Jan. 12, 1999) ...................................11, 14, 15
`
`Ries v. Hornell Brewing Co.,
`No. 10-cv-1139-JF, 2010 WL 2943860 (N.D. Cal. July 23, 2010) ..........................................6
`
`Salmon River Concerned Citizens v. Robertson,
`32 F.3d 1346 (9th Cir. 1994) ..................................................................................................16
`
`Salmon Spawning v. Gutierrez,
`545 F.3d (9th Cir. 2008) .........................................................................................................15
`
`Shawnee Trail Conservancy v. USDA,
`222 F.3d 383 (7th Cir. 2000) ..................................................................................................17
`
`Smith v. Pac. Props. and Dev. Corp.,
`358 F.3d 1097 (9th Cir. 2004) ..................................................................................................7
`
`Steel Co. v. Citizens for a Better Env’t,
`523 U.S. 83 (1998)......................................................................................................2, 7, 8, 15
`
`Summers v. Earth Island Inst.,
`555 U.S. 488 (2009)..........................................................................................................10, 12
`
`Susan B. Anthony List v. Driehaus,
`573 U.S. 149 (2014)............................................................................................................9, 11
`
`ThermoLife Int’l, LLC v. Gaspari Nutrition, Inc.,
`648 F. App’x 609 (9th Cir. 2016) ...........................................................................................19
`
`Tri-Bio Labs, Inc. v. United States,
`836 F.2d 135 (3d Cir. 1987) ...................................................................................................19
`ELANCO’S MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
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`Tyler v. Cuomo,
`236 F.3d 1124 (9th Cir. 2000) ................................................................................................13
`
`U.S. Postal Serv. v. Gregory,
`534 U.S. 1 (2001)....................................................................................................................15
`
`Unemployment Comp. Comm’n of Territory of Alaska v. Aragan,
`329 U.S. 143 (1946)................................................................................................................20
`
`United States v. L.A. Tucker Truck Lines, Inc.,
`344 U.S. 33 (1952)..................................................................................................................20
`
`W. Watersheds Project v. Kraayyenbrink,
`632 F.3d 472 (9th Cir. 2011) ..................................................................................................13
`
`Wash. Envt’l Council v. Bellon,
`732 F.3d 1131 (9th Cir. 2013) ................................................................................................14
`
`Weinberger v. Bentex Pharms., Inc.,
`412 U.S. 645 (1973)................................................................................................................19
`
`Woodford v. Ngo,
`548 U.S. 81 (2006)......................................................................................................17, 21, 22
`
`Statutes
`
`5 U.S.C. § 701...............................................................................................................................18
`
`5 U.S.C. § 704.....................................................................................................................1, 17, 18
`
`21 U.S.C. § 301...............................................................................................................................1
`
`21 U.S.C. § 360b.....................................................................................................................19, 23
`
`33 U.S.C. § 1311...........................................................................................................................14
`
`42 U.S.C. § 4321.............................................................................................................................1
`
`Regulations
`
`21 C.F.R. § 10.3 ............................................................................................................................18
`
`21 C.F.R. § 10.25 ................................................................................................................2, 18, 20
`
`21 C.F.R. § 10.35 ................................................................................................................5, 18, 20
`
`21 C.F.R. § 10.45 ................................................................................................................2, 18, 20
`
`21 C.F.R. § 25.52 ..........................................................................................................................19
`
`21 C.F.R. § 514.115 ................................................................................................................19, 20
`ELANCO’S MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
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`40 C.F.R. § 412.1 ..........................................................................................................................14
`
`Rules
`
`Federal Rule of Civil Procedure 8 ..................................................................................1, 2, 23, 24
`
`Federal Rule of Civil Procedure 12 ................................................................................1, 2, 23, 24
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`ELANCO’S MOTION TO DISMISS
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`NOTICE OF MOTION
`Please take notice that on January 14, 2021, at 1:30 p.m., or as soon thereafter as the
`matter may be heard before the Honorable Richard Seeborg, United States District Judge, in
`Courtroom 3 of the United States Courthouse, 450 Golden Gate Avenue, San Francisco,
`California 94102, Intervenor-Defendant Elanco Animal Health (“Elanco”) will, and hereby does,
`move the court for an order dismissing the First Amended Complaint filed by Plaintiffs Animal
`Legal Defense Fund (“ALDF”), Food & Water Watch (“FWW”), and Food Animal Concerns
`Trust (“FACT”) (collectively, “Plaintiffs”) for lack of Article III standing; failure to exhaust
`mandatory administrative remedies as required by the Administrative Procedure Act (“APA”), 5
`U.S.C. § 704; and failure sufficiently to plead a claim for relief pursuant to Federal Rules of Civil
`Procedure 8 and 12(b)(6). In the alternative, Elanco requests that the Court stay this matter
`pending Plaintiffs’ exhaustion of their administrative remedies, as required by Food and Drug
`Administration (“FDA”) regulations and the APA.
`POINTS AND AUTHORITIES
`INTRODUCTION AND STATEMENT OF ISSUES
`Asserting purported violations of the National Environmental Policy Act (“NEPA”), 42
`U.S.C. §§ 4321, et seq., and the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C.
`§§ 301, et seq., Plaintiffs filed suit under the APA challenging FDA approvals of the animal drug
`lubabegron, which is administered to animals in feed and known under the trade name Experior.
`Plaintiffs claim that FDA’s approvals of Experior should be vacated and all use of Experior barred
`until FDA conducts further reviews of Experior’s safety, effectiveness, and potential
`environmental impacts.
`Plaintiffs’ lawsuit mirrors ALDF’s prior challenge to FDA’s approval of a different
`approved Elanco animal drug that is also administered in feed, ractopamine. The district court
`dismissed that complaint for failure to exhaust the citizen petition review procedures required by
`FDA regulations, see Ctr. for Food Safety v. Hamburg, 142 F. Supp. 3d 898 (N.D. Cal. 2015),
`and, on appeal, the Ninth Circuit directed ALDF “to comply with the FDA’s citizen petition
`requirement” before proceeding in court, Ctr. for Food Safety v. Hamburg, 696 F. App’x 302, 304
`ELANCO’S MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
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`1
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`(9th Cir. 2017). But Plaintiffs here did not heed that instruction, and have proceeded with their
`claims in this Court without first exhausting FDA’s citizen petition review procedures. See 21
`C.F.R. § 10.25(a); id. § 10.45(b). The doctrine of administrative exhaustion therefore precludes
`judicial review of Plaintiffs’ claims until Plaintiffs comply with the administrative procedures
`mandated by FDA’s regulations.
`Plaintiffs’ claims should also be dismissed on two additional, independent grounds. First,
`Plaintiffs’ claims should be dismissed for lack of Article III standing. To have standing to sue,
`Plaintiffs must plausibly allege (and ultimately prove) that they suffer a cognizable injury that is
`fairly traceable to FDA’s alleged statutory violations, and likely to be redressed by an order from
`this Court vacating approval of Experior. See, e.g., Steel Co. v. Citizens for a Better Env’t, 523
`U.S. 83, 102–03 (1998). Reflecting the fact that Experior is not yet on the market, Plaintiffs’
`Amended Complaint asserts only future injuries that could occur if Experior becomes available
`for sale, if feedlot operators then use Experior in ways that result in discharges into the
`environment, and if those discharges adversely affect Plaintiffs’ members. Because those
`hypothetical injuries rely on lengthy, speculative chains of causation, they are insufficiently
`imminent to satisfy Article III’s requirements. See Clapper v. Amnesty Int’l USA, 568 U.S. 398,
`409 (2013). Plaintiffs’ FDCA and NEPA claims must therefore be dismissed.
`Plaintiffs’ NEPA claims further fail to satisfy Article III’s causation and redressability
`requirements. Because Plaintiffs’ alleged environmental injuries from the future discharge of
`Experior at industrial cattle feedlots hinge upon regulatory actions (or inaction) of the
`Environmental Protection Agency (“EPA”), Plaintiffs’ challenge to FDA’s NEPA review lacks
`the causal and remedial connections necessary to satisfy Article III.
`Second, Plaintiffs’ challenge to FDA’s denial of ALDF’s petition for an administrative
`stay (“Stay Petition”) should be dismissed for failure adequately to plead a claim for relief.
`Federal Rules of Civil Procedure 8 and 12(b)(6) require a plaintiff to set forth both the legal
`theories and relief requested for each claim asserted in a Complaint. Plaintiffs’ contention that
`FDA improperly denied ALDF’s Stay Petition, however, alleges only that the denial provides
`Plaintiffs an exhausted final agency action subject to judicial review, see First Am. Compl.
`ELANCO’S MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
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`2
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`

`Case 3:20-cv-03703-RS Document 35 Filed 10/29/20 Page 10 of 31
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`(“FAC”) (Dkt. No. 30), First Claim for Relief, ¶¶ 4, 6, not that any relief—either vacatur of the
`denial decision or a stay of the effective date of Experior’s approval—is due for the alleged legal
`violation. Absent an appropriate request for relief, the claim cannot proceed.
`Viewed collectively and individually, Plaintiffs’ claims are legally deficient, and should
`be dismissed. In the alternative, the Court should stay this litigation “to allow [Plaintiffs] to
`comply with the FDA’s citizen petition requirement.” Ctr. for Food Safety, 696 F. App’x at 304.
`STATEMENT OF FACTS
`Plaintiffs challenge FDA’s approval of New Animal Drug Applications (“NADAs”) for
`Experior, a drug approved for use in cattle alone and in combination with certain antibiotics, that
`reduces ammonia gas emissions in animals’ waste. FAC ¶¶ 1, 4, 12; see also Declaration of Karen
`Smith, Ph.D (Dkt. No. 18-1), ¶ 4. Plaintiffs allege that FDA approved Experior without following
`NEPA’s procedural requirements for review of potential environmental impacts, and without
`adequately determining Experior’s safety and effectiveness in its target animals as required by the
`FDCA. See, e.g., FAC ¶ 2.
`Plaintiffs first allege that FDA’s environmental analysis of Experior’s future use violated
`NEPA by failing to account for “poor manure management conditions” and EPA’s
`“underregulat[ion]” of concentrated animal feeding operations (“CAFOs”) where Experior may
`be used. Id. ¶ 154. Plaintiffs contend that, while FDA disclosed the possibility that Experior may
`enter the environment through land application of manure and corresponding runoff, FDA did not
`consider “several known risks of environmental contamination due to CAFO manure management
`practices that will enable Experior to permeate the environment.” Id. ¶¶ 149–50. In Plaintiffs’
`view, NEPA requires FDA to consider, among other things, that “manure can be stored in unlined
`lagoons that are susceptible to leakage, overflow, or rupture, any of which could lead to
`groundwater and soil contamination” and that “uneaten medicated feed” may also contaminate
`groundwater and soil. Id. ¶ 150. Taken as whole, Plaintiffs allege that FDA’s approvals of
`Experior “exacerbat[e] the existing animal, public, and environmental health effects of the CAFO
`industry.” Id. ¶ 120.
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`ELANCO’S MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
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`Plaintiffs further assert that FDA’s approval of Experior—which Plaintiffs recognize has
`not yet become available in the marketplace, see id. ¶ 33—has injured their members and
`supporters. See id. ¶¶ 19–35. According to Plaintiffs, some of their members “live, work, and
`recreate near and downstream from cattle feedlots that may give their cows Experior.” Id. ¶¶ 19,
`26, 28, 30 (emphasis added). Plaintiffs contend that their members are “concerned” that there is
`a “risk that Experior will migrate from feedlots and contaminate waterways and groundwater,”
`id. ¶ 20, and that their members’ enjoyment of the environment is therefore “diminished by their
`concern and the increased risk of harm Experior presents for wildlife and their habitat,” id. ¶ 21.
`To contend with this concern, Plaintiffs allege that some of their members have altered or will
`alter whether and how they use the waterways. See, e.g., id. ¶¶ 21–24. For example, Plaintiffs
`assert that one ALDF member enjoys boating on the Mississippi River “but is hesitant to engage
`in other activities such as kayaking and swimming in the river in the future because these activities
`involve being in contact with the river and therefore more exposed to Experior.” Id. ¶ 24.
`Similarly, Plaintiffs allege that a FACT member who lives near Lake Michigan currently “avoids
`swimming in the waterway due to concerns about the health impacts of contaminants” and his
`“knowledge that feedlots near Lake Michigan may begin to use Experior heightens his concerns
`and would lead him to avoid swimming even if other more easily detectable contaminants in the
`waterway decrease.” Id. ¶ 31. And Plaintiffs contend that a FWW member who enjoys visiting
`conservation areas in Idaho has already “paused plans to purchase a paddleboard to use on
`waterways near her because of her concerns about direct exposure to Experior-contaminated water
`downstream.” Id. ¶ 28. Plaintiffs assert that the member “will be even more apprehensive to
`invest in this activity,” “[i]f Experior [is] released into these waterways.” Id.
`Plaintiffs also assert that their members are “concerned” about the human health impacts
`of consuming beef from cows that may be treated with Experior. See, e.g., id. ¶¶ 22–24, 26–27.
`“To alleviate their concerns,” Plaintiffs say their members “will be forced to source and consume
`beef that is raised without Experior” and they “will pay premiums to purchase beef raised without
`Experior” or will “simply be unable to find and source beef that is raised without Experior.” Id.
`¶ 22.
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`Plaintiffs further allege that FDA’s approval decisions violated the FDCA by relying on
`studies that are, in Plaintiffs’ estimation, inadequate to assess Experior’s safety and effectiveness
`in target animals. Id. ¶¶ 132–48. In particular, Plaintiffs contend that the studies relied upon by
`FDA “contained inadequate experimental conditions to simulate feedlots,” “were based on small
`sample sizes,” and “did not look adequately at biologically plausible and probable adverse events”
`such as “lameness and overheating.” Id. ¶¶ 132–34. Plaintiffs also allege that FDA improperly
`“dismissed” other concerns about Experior’s safety, and otherwise relied on studies allegedly
`marred by “a certain amount of data manipulation” regarding Experior’s effectiveness. Id.
`¶¶ 132–48.
`Prior to filing this lawsuit, “Plaintiff ALDF submitted a . . . Petition for Stay” of FDA’s
`“approval of NADA 141-508 for Experior and the corresponding” NEPA review documents
`because, in ALDF’s view, “Experior has not been shown to be safe and effective,” and Experior
`has “the potential . . . to cause significant harm to the environment . . . .” Id. ¶¶ 125–26. The
`other two Plaintiffs in this suit—Food & Water Watch and Food Animal Concerns Trust—did not
`join in ALDF’s stay application and have not taken any action before FDA with respect to the
`claims they assert here.
`On May 20, 2019, FDA denied ALDF’s Stay Petition, concluding “that the Petition did
`not meet the conditions set out in 21 C.F.R. § 10.35(e) requiring issuance of a stay.” FAC ¶ 128.
`The agency explained that “[d]uring the new animal drug review process, FDA thoroughly
`reviewed the NADA for Experior and determined the drug met the standards for approval under
`the [FDCA] and FDA regulations.” FDA Denial Letter, at 3 (May 20, 2019).1 Among other
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`1 Both ALDF’s Stay Petition and FDA’s Denial Letter are available on the federal government’s
`regulatory website. See Requests that the FDA stay approval of New Animal Drug Application
`141-508 for Experior™ (lubabegron Type A medicated article) and the corresponding
`Environmental Assessment and Finding of No Significant Impact (Docket No. FDA-2018-P-
`4656), available at https://www.regulations.gov/docket?D=FDA-2018-P-4656 (last visited
`October 29, 2020). In reviewing a motion to dismiss, this Court “can consider exhibits attached
`to the Complaint or matters properly subject to judicial notice,” as well as “documents whose
`contents are alleged in a complaint and whose authenticity no party questions, but which are not
`physically attached to the . . . pleading.” Hicks v. PGA Tour, Inc., 897 F.3d 1109, 1117 (9th Cir.
`2018) (citations and quotations omitted). Plaintiffs’ Complaint alleges the contents of ALDF’s
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`things, FDA reasoned that ALDF’s Stay Petition repeatedly failed to “provide any specific data
`or information in support of” its assertions that FDA inadequately considered the potential health
`or environmental effects of approving Experior. Id. at 9; see also id. (finding that Stay Petition
`“does not contain an explanation of, or support for, the concern” with food safety); id. at 10 (“The
`[Stay] Petition also asserts, without providing any support, that beta-agonists are ‘known to
`increase aggression and hyperactivity in animals[.]’”); id. at 12 (Stay Petition’s “assertion that the
`approval of Experior™ will lead to a denser packing of feedlots . . . is unsupported anywhere in
`the [Stay] Petition”); id. at 14 (finding “the [Stay] Petition failed to provide support for the
`assertion that the daily manure production number used in the Experior™ [environmental
`assessment] is underestimated”).
`More than a year after FDA denied ALDF’s Stay Petition—and eighteen months after
`FDA’s initial approval of the NADA for Experior—Plaintiffs filed the instant lawsuit. See Compl.
`(Dkt. No. 1). On September 29, 2020, Plaintiffs filed their First Amended Complaint. See
`generally FAC. In Plaintiffs’ view, ALDF’s “timely petition to stay exhausts administrative
`remedies,” id., First Claim for Relief, ¶ 4 (citing 21 C.F.R. § 10.45(c)), and “FDA’s denial of . . .
`ALDF’s [Stay] Petition . . . is final agency action subject to judicial review under the APA,” id.
`¶ 6 (citing 5 U.S.C. § 704). To remedy the allegedly unlawful approval of Experior, Plaintiffs ask
`this Court to (1) “[v]acate FDA’s decision to approve Experior unless and until it complies with
`the FDCA, NEPA, and the APA”; and (2) “[i]ssue preliminary