Case 3:20-cv-03703-RS Document 54 Filed 02/23/21 Page 1 of 9
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`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
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`ANIMAL LEGAL DEFENSE FUND, et al.,
`Plaintiffs,
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`v.
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`ALEX AZAR, et al.,
`Defendants.
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`Case No. 20-cv-03703-RS
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`
`ORDER DENYING MOTIONS TO
`DISMISS
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`I. INTRODUCTION
`Plaintiffs challenge the decision of the Food and Drug Administration (FDA) to approve
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`the animal drug Experior for use in cattle feedlots. Experior is touted to reduce the amount of
`ammonia gas released from the waste of cattle raised for beef. Plaintiffs contend the FDA did not
`properly announce the approval in the Federal Register, that Experior has not been shown to be
`safe and effective, and that the FDA did not adequately consider the drug’s environmental
`impacts. The FDA moves to dismiss, arguing plaintiffs lack Article III standing. Elanco Health,
`the manufacturer of Experior, has intervened as a defendant and also moves to dismiss. Elanco
`offers substantially the same arguments regarding standing, but also contends plaintiffs failed to
`exhaust administrative remedies. For the reasons explained below, the motions to dismiss will be
`denied.
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`Case 3:20-cv-03703-RS Document 54 Filed 02/23/21 Page 2 of 9
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`II. BACKGROUND
`Plaintiffs are advocacy groups Animal Legal Defense Fund (“ALDF”), Food & Water
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`Watch (“FWW”), and Food Animal Concerns Trust (“FACT”). As noted, they challenge the
`FDA’s approval of Experior, asserting claims under the Administrative Procedures Act (“APA”),
`5 U.S.C. § 551, et seq. for alleged underlying failures to comply with the Federal Food, Drug, and
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`Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., and the National Environmental Policy Act
`(“NEPA”), 42 U.S.C. § 4321 et seq. Experior purportedly has been shown to lower ammonia gas
`emissions from cattle waste, where the animals are raised in pastures and then “finished” on feed
`while in confinement in the last weeks or months prior to slaughter. Experior is classified as an
`adrenergic agonist/antagonist, which is a subtype of a broader category of drugs known as beta-
`adrenergic agonist/antagonists (“β-AA”). It is the first approved animal drug that activates from
`the beta-3 receptor (“beta-3”) subtype and the first approved for the purpose of reducing gas
`emissions from an animal or its waste.
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`Plaintiffs allege that β-AA drugs like Experior are linked to “significantly higher mortality
`rates in cows due to a host of fatal respiratory, cardiac, and digestive issues, in addition to
`significant behavioral issues that make animals more likely to be abused and suffer in ways that
`directly impact food safety and worker health.” Plaintiffs contend the drugs also contaminate the
`environment.
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`Plaintiffs allege the application for approval of Experior was insufficient to establish its
`safety, or that when actually used under approved conditions, it will have its intended effect of
`reducing the release of ammonia gas. Plaintiffs contend the FDA also failed to consider the food
`safety and public health risk of its decision. They allege β-AA drug residues end up in meat
`products and have been linked to human heart and respiratory issues in consumers, producers, and
`farm workers. Plaintiffs assert β-AA drugs also increase the likelihood that an animal will
`experience injury and stress at industrial animal feeding operations—so-called “factory farms”—
`and at the slaughterhouse, which in turn makes animals more susceptible to pathogens, and
`increases their susceptibility to and shedding of zoonotic bacteria such as salmonella.
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`Case 3:20-cv-03703-RS Document 54 Filed 02/23/21 Page 3 of 9
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`Plaintiffs complain the Environmental Assessment (“EA”) prepared in support of
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`Experior’s approval also failed adequately to analyze whether it will have a significant impact on
`the environment. They insist the EA made no meaningful attempt to address the cumulative
`impacts of the “current rampant use of β-AAs and other animal drugs in cows slaughtered for food
`in the United States.” Plaintiffs contend the FDA’s Finding of No Significant Impact did not
`consider any alternatives, involve the public in the review process, or explain why an
`Environmental Impact Statement (“EIS”) was not required under NEPA.
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`Following the approval, plaintiff ALDF filed a timely Petition for Stay of Action under 21
`C.F.R. § 10.35. The petition alleged that the FDA failed to analyze sufficiently Experior’s
`environmental impact, did not consider alternatives to Experior’s approval, and failed to prepare
`an EIS addressing the effects Experior may have on animals, humans, and the environment. The
`petition requested the FDA to stay Experior’s approval until the agency addressed ALDF’s
`concerns. The FDA denied the petition. This action followed shortly thereafter.
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`III. LEGAL STANDARD
`The FDA challenges the sufficiency of the jurisdictional allegations in the amended
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`complaint under Federal Rule of Civil Procedure 12(b)(1). See Safe Air for Everyone v. Meyer,
`373 F.3d 1035, 1039 (9th Cir. 2004). Although a court may “assume [a plaintiff’s] allegations to
`be true and draw all reasonable inferences in [its] favor,” Wolfe v. Strankman, 392 F.3d 358, 362
`(9th Cir. 2004), “plaintiff, as the party invoking federal jurisdiction, bears the burden of
`establishing the[] elements” of standing, Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016).
`“Where, as here, a case is at the pleading stage, the plaintiff must ‘clearly . . . allege facts
`demonstrating’ each element” of standing to secure this Court’s jurisdiction. Id. (quoting Warth v.
`Seldin, 422 U.S. 490, 518 (1975)). “[W]hen considering a motion to dismiss pursuant to Rule
`12(b)(1) the district court is not restricted to the face of the pleadings, but may review any
`evidence, such as affidavits and testimony, to resolve factual disputes concerning the existence of
`jurisdiction.” Gordon v. United States, 739 F. App’x 408, 411 (9th Cir. 2018) (quoting McCarthy
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`v. United States, 850 F.2d 558, 560 (9th Cir. 1988) (alteration in original)).
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`Elanco’s motion also invokes Rule 12(b)(6) of the Federal Rules of Civil Procedure. A
`motion under that rule tests the legal sufficiency of the claims alleged in the complaint. See
`Conservation Force v. Salazar, 646 F.3d 1240, 1241-42 (9th Cir. 2011). Dismissal under Rule
`12(b)(6) may be based on either the “lack of a cognizable legal theory” or on “the absence of
`sufficient facts alleged under a cognizable legal theory.” Id. at 1242 (internal quotation marks and
`citation omitted). When evaluating such a motion, the court must accept all material allegations in
`the complaint as true and construe them in the light most favorable to the non-moving party. In re
`Quality Sys., Inc. Sec. Litig., 865 F.3d 1130, 1140 (9th Cir. 2017).
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`IV. DISCUSSION
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`A. Standing
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`To satisfy Article III standing requirements, a plaintiff must show “(1) it has
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`suffered an ‘injury-in-fact’ that is (a) concrete and particularized and (b) actual or imminent, not
`conjectural or hypothetical; (2) the injury is fairly traceable to the challenged action of the
`defendant; and (3) it is likely, as opposed to merely speculative, that the injury will be redressed
`by a favorable decision.” Friends of the Earth, Inc., v. Laidlaw Envtl. Servs. (TOC), Inc., 528
`U.S. 167, 180–81 (2000) (citing Lujan v. Defs. of Wildlife, 504 U.S. 555, 560–61 (1992)).
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`The FDA first argues the plaintiff organizations cannot establish standing for themselves
`as entities (which the FDA refers to as “organizational standing”). Plaintiffs, however, expressly
`disclaim any intent to assert such standing, arguing instead that they have “associational standing.”
`There is no dispute that an organization may have standing if it can show “that its members, or any
`one of them, are suffering immediate or threatened injury as a result of the challenged action of
`the sort that would make out a justiciable case had the members themselves brought suit. . . .”
`See Hunt v. Wash. State Apple Growers Ass’n, 432 U.S. 333, 342 (1977). Specifically, “an
`association has standing to bring suit on behalf of its members when: (a) its members would
`otherwise have standing to sue in their own right; (b) the interests it seeks to protect are germane
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`CASE NO. 20-cv-03703-RS
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`Northern District of California
`United States District Court
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`Case 3:20-cv-03703-RS Document 54 Filed 02/23/21 Page 5 of 9
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`to the organization’s purpose; and (c) neither the claim asserted nor the relief requested requires
`the participation of individual members in the lawsuit.” Id. at 343. There is no challenge here to
`plaintiffs’ assertion that the interests they seek to protect are germane to their purposes and that
`participation of their individual members is not required. The issue, therefore, is solely whether
`one or more of plaintiffs’ members would otherwise have standing to sue in their own right.
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`1. Injury-in-fact
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`The FDA and Elanco both contend plaintiffs cannot show any of their members have
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`suffered the requisite injury-in-fact to support standing. Defendants advance two basic arguments.
`First, defendants contend because Experior has not come to market yet and no firm date for its
`release has been set, plaintiffs cannot show imminent harm. Elanco, however, has announced that
`the drug will be available in the first quarter of this year. While that may not be certain, it is
`neither “conjectural or hypothetical,” and satisfies the requirement that the harm be imminent.1
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`Second, defendants insist that because plaintiffs cannot identify specific feedlots that will
`purchase and use Experior, they cannot show that any of their members have the geographical
`proximity to suffer any of the alleged effects of Experior on the environment, or that any beef they
`purchase for consumption necessarily will come from cattle treated with the drug. The
`requirement defendants seek to impose, however, would effectively insulate the FDA’s decision-
`making from review until the product had entered the market and its use at specific feedlots could
`somehow be discovered, or detected in the environment, or in beef products sold to consumers.
`Plaintiffs’ claim is that the FDA was derelict in its duty to ensure the safety of Experior and to
`weigh its environmental impacts before it is released on the market.
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`Defendants may be correct that plaintiffs have not yet shown that any of its members
`certainly will be exposed to Experior or that any such exposure certainly will cause measurable
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`1 Of course, cognizable harm may not arise the first day the product is available for sale, but the
`fact that some of the alleged injury will develop over time does not mean it is insufficiently
`imminent.
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`Case 3:20-cv-03703-RS Document 54 Filed 02/23/21 Page 6 of 9
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`harm. At least at the pleading stage, however, plaintiffs have adequately identified the imminent
`potential of concrete and particularized harm that is not so conjectural or hypothetical as to
`preclude standing. See Baur v. Veneman, 352 F.3d 625, 633 (2d Cir. 2003) ([T]he courts of
`appeals have generally recognized that threatened harm in the form of an increased risk of future
`injury may serve as injury-in-fact for Article III standing purposes.”)2
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`2. Causation
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`Defendants argue that the various harms plaintiffs contend their members will suffer are
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`not actually caused by the FDA’s approval of Experior. Indeed, the complaint’s lengthy
`description of the alleged harms flowing from various feedlot and factory farming practices
`supports a reasonable inference that even assuming Experior were now to be banned, many of the
`injuries to which plaintiffs point would continue unabated. Nevertheless, plaintiffs’ allegations
`that the situation is bad even without Experior do not preclude them from plausibly contending
`that Experior will make things worse.
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`That other factors, and other actors, may play a role in the constellation of circumstances
`that will result in cognizable harm does not mean no injury will be traceable to the FDA’s
`approval of Experior. Indeed, part of plaintiffs’ claim is that the FDA failed to give adequate
`attention to the cumulative effects of Experior and such other factors. Such effects are necessarily
`traceable to the challenged agency action.
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`2 Some of defendants’ arguments seem to conflate the standing inquiry with merits questions. The
`FDA suggests, for example, that plaintiffs cannot show imminent harm because the permissible
`residual levels of Experior in beef is safe for human consumption. While standing inquiry does
`require plaintiffs to make credible allegations of harm, it would be premature to dismiss plaintiffs’
`contentions of harm here by assuming that the FDA correctly evaluated the risks.
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`This order does not necessarily preclude defendants from challenging standing at a later stage in
`the proceedings, on a more developed record, if warranted.
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`Case 3:20-cv-03703-RS Document 54 Filed 02/23/21 Page 7 of 9
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`3. Redressability
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`Defendants’ contention that plaintiffs cannot establish redressability is premised on their
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`arguments that the alleged harms are not traceable to the approval of Experior. Because that
`premise fails, as discussed above, so does the attack on redressability. Accordingly, the motions
`to dismiss for lack of standing must be denied.
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`B. Exhaustion
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`The APA requires “that plaintiffs exhaust available administrative remedies before
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`bringing their grievances in federal court.” Idaho Sporting Congress, Inc. v. Rittenhouse, 305 F.3d
`957, 965 (9th Cir.2002) (citing 5 U.S.C. § 704). FDA regulations set out the exhaustion
`requirement and procedure in 21 C.F.R. § 10.45, which provides, in relevant part:
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` A
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` request that the Commissioner take or refrain from taking any
`form of administrative action must first be the subject of a final
`administrative decision based on a petition submitted under
`§10.25(a) . . . before any legal action is filed in a court complaining
`of the action or failure to act. If a court action is filed complaining of
`the action or failure to act before the submission of the decision on a
`petition under §10.25(a) . . . the Commissioner shall request
`dismissal of the court action or referral to the agency for an initial
`administrative determination on the grounds of a failure to exhaust
`administrative remedies, the lack of final agency action as required
`by 5 U.S.C. 701 et seq., and the lack of an actual controversy as
`required by 28 U.S.C. 2201.
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`It is notable that the FDA has not requested dismissal or referral on grounds of a failure to
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`exhaust. This suggests that in the FDA’s view, the exhaustion requirement has been satisfied.
`Elanco nonetheless contends plaintiffs were required to exhaust their administrative remedies by
`filing a “citizens petition” pursuant to §10.30. Such a citizen’s petition, however, is only one of
`the kinds of “petitions” specified in §10.25(a) as a means of obtaining a final administrative
`decision ripe for court review. That section provides, in relevant part:
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`An interested person may petition the Commissioner to issue,
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`Case 3:20-cv-03703-RS Document 54 Filed 02/23/21 Page 8 of 9
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`amend, or revoke a regulation or order, or to take or refrain from
`taking any other form of administrative action. A petition must be
`either:
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`(1) In the form specified in other applicable FDA regulations . . . or
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`(2) in the form for a citizen petition in §10.30.
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`(emphasis added).
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`Here, as noted above, plaintiff ALDF filed a petition for stay under §10.35. Decisions on
`such petitions are final agency actions, ripe for court review. See §10.45(d).
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`To argue plaintiffs must have additionally filed a citizen petition under §10.30, Elanco
`relies on Center for Food Safety v. Hamburg, 696 F. App’x 302 (9th Cir. 2017), in which it also
`intervened, and where ALDF was also party, represented by the same counsel as here.3 In
`Hamburg, however, no stay petition under §10.35 had been filed. The court’s pronouncement that
`a citizen petition was required in those circumstances does not support a conclusion that one
`would be necessary where a §10.35 petition was filed.4 Accordingly, Elanco’s motion to dismiss
`or to stay this action pending exhaustion is denied.
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`C. First claim for relief
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`Finally, Elanco argues the first claim for relief is subject to dismissal under Rule 12(b)(6)
`for “failure to request any relief.” The claim asserts the FDA’s denial of the stay petition violated
`the APA because it “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
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`3 In Hamburg, the FDA had not initially challenged exhaustion, but did so after Elanco raised the
`issue. See Ctr. for Food Safety v. Hamburg, 142 F. Supp. 3d 898, 900 n.2 (N.D. Cal. 2015). In
`contrast, here the FDA has not joined in the exhaustion argument.
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`4 Admittedly, the relief sought in the stay petition was not completely coextensive with the relief
`being sought here. Nevertheless, Elanco has not made a persuasive showing that pursuing a §10.35
`petition is insufficient to satisfy the purposes of the exhaustion requirement. The FDA had the
`opportunity to consider the basic arguments plaintiffs are making here and to reconsider its
`decision, and elected not to do so.
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`Case 3:20-cv-03703-RS Document 54 Filed 02/23/21 Page 9 of 9
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`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.”
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`It may be, as Elanco suggests, that the primary intended purpose of the first claim for relief
`is to establish there is exhaustion as to the entire complaint. It is not clear that plaintiffs
`necessarily would want an adjudication only that the FDA erred in denying the stay petition. In
`theory, though, plaintiffs could prevail on that claim whether or not they prevailed on the bigger
`issue of whether approval of Experior was properly granted. That the complaint does not explicitly
`and unambiguously include a prayer for relief limited to setting aside the denial of the stay petition
`is not a basis to dismiss the first claim for relief.
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`V. CONCLUSION
`The motions to dismiss are denied.
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`IT IS SO ORDERED.
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`Dated: February 23, 2021
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`______________________________________
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`________________________ ____________________________________ _______________________
`RICHARD SEEBORG
`RIRR CHARD SEEBORG
`Chief United States District Judge
`Chief United States District Judge
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