Case 3:20-cv-03703-RS Document 1 Filed 06/04/20 Page 1 of 35
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`PAIGE M. TOMASELLI (State Bar No. 237737)
`The Law Office of Paige Tomaselli
`P.O. Box 71022
`Richmond, CA 94807
`T: (619) 339-3180
`paige@tomasellilaw.com
`CRISTINA R. STELLA (State Bar No. 305475)
`Animal Legal Defense Fund
`525 E. Cotati Avenue
`Cotati, CA 94931
`T: (707) 795-2533 ext. 1055
`cstella@aldf.org
`Counsel for Plaintiffs
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`THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
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`Case No.
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`COMPLAINT FOR DECLARATORY
`AND INJUNCTIVE RELIEF
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`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,
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`Defendants.
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`CASE NO.
`COMPLAINT
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`Case 3:20-cv-03703-RS Document 1 Filed 06/04/20 Page 2 of 35
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`INTRODUCTION
`Plaintiffs Animal Legal Defense Fund (“ALDF”), Food & Water Watch
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`(“FWW”), and Food Animal Concerns Trust (“FACT”) challenge the United States Food and
`Drug Administration’s (“FDA” or “the Agency”) approval of and subsequent denial of a petition
`to stay approval of Experior™ (lubabegron Type A medicated article), a beta 3-adrenergic
`agonist/antagonist (“β3-AA”) manufactured by Elanco US, Inc., that allegedly results in less
`ammonia gas released from the waste produced by cows raised for beef.
`FDA approved Experior on November 6, 2018, in violation of the Federal Food,
`2.
`Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301-399, and the National Environmental
`Policy Act (“NEPA”), 42 U.S.C. §§ 4321-70. This approval will allow producers to administer
`this controversial new drug to the nearly 100 million cows raised for beef in the United States
`despite the facts that FDA did not properly announce the approval in the Federal Register,
`Experior has not been shown to be safe and effective, and FDA did not adequately consider the
`drug’s environmental impacts.
`Beta-adrenergic agonist/antagonist (“β-AA”) drugs like Experior are linked to
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`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. These drugs also
`contaminate the environment.
`Though the negative effects of beta-agonist drugs are widely known and well
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`established, the beta-agonist subtype to which Experior belongs is the least-studied of all
`beta-agonist drugs; the specific mechanism of the drug is not yet understood, even by the drug’s
`sponsor.
`The documents submitted by the drug sponsor as part of its application for
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`approval of Experior illustrate the likelihood it will cause the negative effects typically
`associated with beta-agonists, and also raise significant uncertainty about additional effects both
`intended and unintended.
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`CASE NO.
`COMPLAINT
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`1
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`Case 3:20-cv-03703-RS Document 1 Filed 06/04/20 Page 3 of 35
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`The FDCA requires FDA to refuse any new animal drug application where the
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`application does not show that a drug is safe for use, where FDA has “insufficient information”
`to determine whether a drug is safe for use, or where there is a lack of substantial evidence that
`the drug will have the effect it purports. FDA must deny—not approve—applications for
`approval of new animal drugs that cannot be supported by available science.
`At best, the documents provided to FDA by the drug sponsor in support of its
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`approval are insufficient to establish the drug’s safety—at worst, they show it is unsafe. These
`documents also fail to show that, when actually used under approved conditions, the drug will
`have its intended effect of reducing the release of ammonia gas.
`In approving this drug FDA also failed to consider the increased food safety and
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`public health risk of its decision. 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. β-AA
`drugs also increase the likelihood that an animal will experience injury and stress at industrial
`animal feeding operations—commonly known as factory farms—and at the slaughterhouse;
`stress depresses the immune system, making animals more susceptible to pathogens, and
`increases animals’ susceptibility to and shedding of zoonotic bacteria such as salmonella. These
`effects could have wide ranging implications and expose the public to increased health risks.
`The Environmental Assessment (“EA”) prepared in support of Experior’s
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`approval also failed to adequately analyze whether the approval will have a significant impact on
`the environment. 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. FDA issued a Finding of No Significant Impact (“FONSI”) that 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. Indeed, FDA’s FONSI admits that “both the
`terrestrial and aquatic environments may ultimately be affected by” Experior; yet, it failed to
`prepare an EIS addressing this and other potential impacts on an uncounted number of humans,
`hundreds of thousands of animals, and millions of acres of habitat from the multiple pathways
`through which Experior is discharged into the environment.
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`CASE NO.
`COMPLAINT
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`2
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`Case 3:20-cv-03703-RS Document 1 Filed 06/04/20 Page 4 of 35
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`On December 6, 2018, Plaintiff ALDF submitted a Petition for Stay of Action
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`(“Petition”) to FDA concerning its approval of Experior. ALDF’s petition outlined the
`deficiencies in FDA’s approval and illustrated several things: that the approval will cause
`irreparable harm to Plaintiffs by allowing the use of a drug with known and unknown risks to
`target animal safety, human health, and the environment and is not consistent with the public
`interest; that target animal safety and effectiveness and compliance with environmental laws are
`sound public policy grounds that support a stay; and that public health and other public interests
`clearly outweigh any delay that would occur while FDA conducts the adequate animal and
`human health safety tests and environmental review the law requires.
`FDA denied the Petition on May 20, 2019, based on the same inadequate
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`documents it used to support its underlying decision to approve the drug. Both the decision not to
`stay the approval and the approval itself violate federal law.
`On May 21, 2019, one day after denying ALDF’s Petition, FDA approved
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`additional drugs that combine the original Experior formulation with controversial antibiotics
`tylosin and monensin. These combination drug approvals are tiered to, and therefore suffer from
`the same deficiencies as, the original Experior approval.
`The FDCA simply does not allow FDA to approve animal drugs without
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`sufficient data to support the drug’s safety or efficacy. NEPA similarly requires FDA to
`thoroughly consider a drug’s effects on the environment before approval. These laws mandate
`that FDA thoroughly assess new drugs and their impacts before they are approved; they do not
`allow FDA and drug manufacturers to subject animals, humans, and the environment to
`significant harm while they continue to learn about a new drug. And the FDCA’s public notice
`requirement is meant to these regulatory requirements effect.
`By failing to meet the standards required of it by either statute when it approved
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`Experior and its progeny, FDA violated the FDCA, NEPA, the Administrative Procedure Act
`(“APA”), and its own regulations. This Court should vacate FDA’s unlawful approval of
`Experior and remand this matter to FDA with instructions to carry out any approval in
`accordance with federal law.
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`CASE NO.
`COMPLAINT
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`3
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`Case 3:20-cv-03703-RS Document 1 Filed 06/04/20 Page 5 of 35
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`JURISDICTION AND VENUE
`This Court has jurisdiction over this action under 28 U.S.C. § 1331 (federal
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`question).
`Venue is proper in this Court under 28 U.S.C. § 1391(e) because Plaintiff Animal
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`Legal Defense Fund resides in the Northern District of California.
`Plaintiff Animal Legal Defense Fund resides in the county of Sonoma.
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`Accordingly, assignment to the San Francisco Division or the Oakland Division is proper
`pursuant to Civil Local Rules 3-2(c) and (d).
`This Court may award all necessary injunctive relief pursuant to the APA, 5
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`U.S.C. § 706(1), and may award declaratory relief pursuant to the Declaratory Judgment Act, 28
`U.S.C. §§ 2201-02.
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`PARTIES
`Plaintiff Animal Legal Defense Fund (“ALDF”) is a national nonprofit
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`membership organization founded in 1979 in Cotati, California. ALDF’s mission is to protect the
`lives and advance the interests of animals through the legal system. Advocating for effective
`oversight and regulation of the development, expansion, and pollution of the animal agriculture
`industry across the United States is one of ALDF’s central goals, which it achieves by filing
`lawsuits, administrative comments, and rulemaking petitions to increase legal protections for
`animals; by supporting strong animal protection legislation; and by fighting against legislation,
`like state “Ag Gag” laws, that are harmful to animals and communities surrounding concentrated
`animal feeding operations (“CAFOs”). Through these efforts, ALDF seeks to ensure
`transparency in the CAFO system, which is paramount to its ability to protect farmed animals
`and ALDF members from CAFOs’ immensely harmful effects. ALDF has more than 235,000
`members and supporters throughout the United States, many of whom live near, recreate near,
`and closely monitor CAFOs in their communities.
`Plaintiff Food & Water Watch (“FWW”) is a national, nonprofit membership
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`organization that mobilizes regular people to build political power to move bold and
`uncompromised solutions to the most pressing food, water, and climate problems of our
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`CASE NO.
`COMPLAINT
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`Case 3:20-cv-03703-RS Document 1 Filed 06/04/20 Page 6 of 35
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`time. FWW uses grassroots organizing, media outreach, public education, research, policy
`analysis, and litigation to protect people’s health, communities, and democracy from the growing
`destructive power of the most powerful economic interests. Combating the harms associated with
`industrial farm animal production, also known as factory farming, is one of FWW’s priority
`issues. FWW is engaged in several campaigns to reduce these industrial facilities’ pollution,
`public health threats, harms to rural communities, and animal welfare abuses through stronger
`regulation and enforcement, increased transparency, and public education and engagement.
`FWW has more than a decade of experience advocating for stronger FDA oversight of food
`safety and of products that could harm the environment, including urging stronger oversight of
`antibiotics used in factory farms and challenging FDA’s approval of genetically engineered
`salmon for human consumption. FWW communicates extensively with our members and
`supporters, as well as the general public, about FDA’s oversight of factory farm practices and
`other food safety issues, including by releasing reports and fact sheets, issuing press releases and
`statements, publishing online news pieces, and sending emails and action alerts. FWW has more
`than one million members and supporters nationwide, and maintains offices across the country,
`including an office in Oakland, California.
`Plaintiff Food Animal Concerns Trust (“FACT”) is a national nonprofit
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`advocacy organization based in Illinois. FACT was founded in 1982 as the first U.S.
`organization devoted exclusively to addressing the public health problems that result from
`raising farm animals in confined and inhumane conditions. FACT promotes the safe and humane
`production of meat, milk, and eggs, and envisions and advocates for a food system in which all
`food-producing animals are raised in a healthy and humane manner so that everyone will have
`access to safe and humanely-produced food. With a particular focus on eliminating or curbing
`the use of antibiotics and drugs given to food-producing animals in order to protect consumers
`from drug residues, FACT has long been concerned about both the human health impacts from
`the use of beta-agonist drugs and their impact on animal health and welfare. FACT advocates for
`responsible use of animal drugs by surveying producers and publishing reports and “score cards”
`to educate the public and regulators on the use of animal drugs in the food system. FACT also
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`CASE NO.
`COMPLAINT
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`Case 3:20-cv-03703-RS Document 1 Filed 06/04/20 Page 7 of 35
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`advocates directly to FDA for the withdrawal of beta-agonists. In 2013, FACT successfully
`petitioned and sued FDA to remove arsenic-containing drugs from the food supply.
`Plaintiffs and their members and supporters have a strong interest in preventing
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`FDA approval of unsafe animal drugs that may harm public health, the environment, or animal
`health and welfare. They and their members and supporters are particularly concerned that
`FDA’s approval of Experior will further entrench the harmful factory farm system by making it
`possible for large feedlots to “greenwash” their operations by claiming lower emissions of
`ammonia, which is known to harm human health, rural quality of life, and the environment; they
`are harmed by FDA’s decision to approve an animal drug that is likely to increase cow herd size
`and density at feedlots, and that could encourage construction of new feedlots. ALDF and FWW
`members and supporters, and the consumers on whose behalf FACT advocates, also eat beef
`from cows raised on feedlots and are concerned that FDA’s approval of a novel drug could affect
`the safety of the meat they eat through drug residues and through the increased risk of
`contamination and foodborne illness from animals that Experior may render nonambulatory.
`ALDF and FWW also have members and supporters who live and recreate near, and are
`adversely impacted by, contaminated air and water and odors from feedlots. They also have
`aesthetic interests in the health and lawful treatment of farmed animals. These injuries to
`Plaintiffs and their members and supporters will be redressed if Plaintiffs prevail in this action.
` Defendant Alex Azar is the Secretary of the United States Department of Health
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`and Human Services, which includes FDA. The Secretary of the U.S. Department of Health and
`Human Services, “through the Commissioner” of FDA, regulates new animal drugs. 21 U.S.C.
`§ 393(d)(2). Secretary Azar is named a Defendant solely in his official capacity.
`Defendant Steven Hahn is the Commissioner of FDA. In that capacity, he is
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`directly responsible for overseeing the FDA review process for the Experior application and is
`tasked with the authority to approve, deny, or withdraw approval for Experior upon a finding that
`applicable legal requirements have or have not been met. Commissioner Hahn is named as a
`Defendant solely in his official capacity.
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`CASE NO.
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`Defendant U.S. Food and Drug Administration is a federal agency within the
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`U.S. Department of Health and Human Services. FDA is charged with the regulation of medical
`products, tobacco, foods, and veterinary medicine. As described by the agency itself, FDA is
`responsible for protecting public health by ensuring that human and veterinary drugs are safe and
`effective.
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`STATUTORY AND REGULATORY FRAMEWORK
`Federal Food, Drug, and Cosmetic Act and FDA Regulations
`In enacting the FDCA in 1938, Congress provided FDA the authority and
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`obligation to protect public health and safety by overseeing certain food products, drugs, and
`cosmetics. Through the FDCA, Congress charged FDA with “promot[ing] the public health” by
`ensuring that “human and veterinary drugs are safe and effective.” 21 U.S.C. § 393.
`A “new animal drug” is any drug intended for use in animals that has not been
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`used to a material extent or for a material time and is not recognized by “experts qualified by
`scientific training and experience” as safe and effective for use under the conditions prescribed.
`Id. § 321(v).
`A new animal drug is deemed “unsafe” unless FDA has approved a new animal
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`drug application for the drug and its use conforms to its labeling and the conditions of the
`approved application. Id. § 360b(a)(1).
`The FDCA requires an applicant to submit reports to demonstrate whether its drug
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`is “safe and effective for use.” Id. § 360b(b)(1)(A). The applicant must also submit “other use
`restrictions . . . in order to assure that the proposed use of such drug will be safe.” Id.
`§ 360b(b)(1)(H). FDA regulations require an applicant to submit evidence to establish the “safety
`and effectiveness” of a new animal drug. 21 C.F.R. § 514.1(8).
`The FDCA requires FDA to refuse any new animal drug application where: the
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`results of “adequate tests by all methods reasonably applicable” either “show that such drug is
`unsafe for use under [prescribed] conditions or do not show that such drug is safe for use under
`such conditions”; it “has insufficient information to determine whether such drug is safe for use
`under such conditions”; or “there is a lack of substantial evidence that the drug will have the
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`CASE NO.
`COMPLAINT
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`Case 3:20-cv-03703-RS Document 1 Filed 06/04/20 Page 9 of 35
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`effect it purports or is represented to have under the conditions of use prescribed, recommended,
`or suggested in the proposed labeling thereof.” 21 U.S.C. § 360b(d)(1).
`The FDCA does not define the phrases “safe and effective” or “safety and
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`effectiveness,” or the term “effective.” The statute states generally that the term “safe” “has
`reference to the health of man or animal.” Id. § 321(u). But in considering whether a drug is
`“safe,” FDA may consider, among other things: (1) “the cumulative effect on man or animal of
`such drug”; (2) “safety factors” that experts consider appropriate; and (3) whether the conditions
`in the proposed labeling are reasonably certain to be followed. Id. § 360b(d)(2). When evaluating
`the sufficiency of the information about a drug’s safety and effectiveness, FDA must similarly
`consider “(A) the probable consumption of such drug and of any substance formed in or on food
`because of the use of such drug, (B) the cumulative effect on man or animal of such drug, taking
`into account any chemically or pharmacologically related substance, (C) safety factors which in
`the opinion of experts, qualified by scientific training and experience to evaluate the safety of
`such drugs, are appropriate for the use of animal experimentation data, and (D) whether the
`conditions of use prescribed, recommended, or suggested in the proposed labeling are reasonably
`certain to be followed in practice.” 21 C.F.R. § 514.111(a)(4).
`The FDCA requires FDA to publish approval of new animal drug applications in
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`the Federal Register. 21 U.S.C. § 360(i). This notice must include “conditions and indications of
`use of the new animal drug . . . and such other information, . . . as the Secretary deems necessary
`to assure the safe and effective use of such drug.” Id.; see also 21 C.F.R. § 514.105.
`FDA’s authority to oversee and enforce approvals of new animal drugs is tied to
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`the continued “safety” of a drug. A drug is considered “unsafe” post-approval if its use does not
`conform to the approved application. 21 U.S.C. § 360b(a)(1)(A). FDA also has authority to
`withdraw approval of a new animal drug if it finds that its use is “unsafe” even under the
`approved conditions or if the applicant makes any changes from the standpoint of “safety or
`effectiveness.” Id. § 360b(e)(1).
`An interested person can, within 30 days of the approval, request that FDA stay a
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`particular approval pending further review. 21 C.F.R. § 10.35(b). FDA’s Commissioner must
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`grant a stay in any proceeding if all of the following apply: (1) the petitioner will otherwise
`suffer irreparable injury; (2) the petitioner’s case is not frivolous and is being pursued in good
`faith; (3) the petitioner has demonstrated sound public policy grounds supporting a stay; and (4)
`the delay resulting from the stay is not outweighed by public health or other public interests. Id.
`at (e)(1).
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`National Environmental Policy Act
`NEPA is “our basic national charter for protection of the environment.” 40 C.F.R.
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`§ 1500.1(a). NEPA emphasizes the importance of comprehensive environmental analysis and
`requires the action agency—here, FDA—to make informed decisions by taking a “hard look” at
`potential environmental consequences before taking action. It also ensures that “environmental
`information is available to public officials and citizens before decisions are made and before
`actions are taken.” Id. § 1500.1(b).
`All “major Federal actions significantly affecting the quality of the human
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`environment” require the preparation of a detailed EIS by the action agency. 42 U.S.C.
`§ 4332(2)(C). Thus, a threshold determination is whether a proposed project may “significantly
`affect” the environment.
`37. Congress created the Council on Environmental Quality (“CEQ”) to implement
`NEPA by promulgating regulations applicable to all federal agencies. Id. § 4342.
`38. CEQ’s regulations direct agencies to prepare an EA to determine whether the
`proposed action will have a significant impact on the environment and warrant the preparation
`of an EIS. 40 C.F.R. § 1508.9. An EA must provide sufficient evidence and analysis to allow an
`agency to determine whether it should prepare an EIS or a FONSI.
`CEQ regulations require an agency to consider the direct, indirect, and cumulative
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`impacts of a proposed action’s impact on the environment, as well as “considerations of both
`context and intensity.” Id. §§ 1508.8, 1508.27. Context considerations include analysis of the
`action’s impact on affected regions, varying by the locality of the action, as well as national and
`societal impacts. Id. § 1508.27. Intensity refers to the severity of the impact, and requires the
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`CASE NO.
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`Case 3:20-cv-03703-RS Document 1 Filed 06/04/20 Page 11 of 35
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`agency to consider ten factors, including, among others: beneficial and adverse impacts; public
`health or safety impacts; unique characteristics of the affected geographic area, such as proximity
`to ecologically critical areas; the degree to which the effects are likely to be highly controversial;
`highly uncertain risks; precedential effects; cumulatively significant impacts; and adverse effects
`on threatened and endangered species. Id.
`NEPA further requires agencies to “rigorously explore and objectively evaluate
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`all reasonable alternatives.” Id. § 1502.14(a); 42 U.S.C. § 4332(2)(E).
`If an agency decides not to prepare an EIS, it must explain why a project will not
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`have a significant effect on the environment. 40 C.F.R. § 1508.13.
`A new animal drug application must either contain an EA or present an analysis
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`and justification for why the applicant believes that it qualifies for a categorical exclusion under
`NEPA. 21 C.F.R. § 514.1(b)(14). Consideration of this information is integral to FDA’s review
`of the application. See id. § 514.110(b)(10). FDA must reject the application if “[t]he applicant
`fails to submit an adequate environmental assessment . . . or fails to provide sufficient
`information to establish that the requested action is subject to categorical exclusion . . . .” Id.
`§ 514.111(a)(9).
`FDA’s regulations categorically exclude new animal drug applications and
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`supplemental New Animal Drug Applications from NEPA review only if the action does not
`increase the use of the drug. Id. § 25.33(a).
`A normally categorically excluded action requires at least an EA if “extraordinary
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`circumstances” indicate that the proposed action “may significantly affect the quality of the
`human environment.” Id. § 25.21. FDA’s regulations cite the CEQ context and intensity
`regulations for examples of significant impacts and explicitly provide two examples of
`extraordinary circumstances: actions where “there is potential for serious harm to the
`environment,” and actions that adversely affect listed threatened or endangered species or their
`critical habitat. Id.
`//
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`CASE NO.
`COMPLAINT
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`Case 3:20-cv-03703-RS Document 1 Filed 06/04/20 Page 12 of 35
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`Administrative Procedure Act
`The APA grants a right of judicial review to “[a] person suffering legal wrong
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`because of agency action, or adversely affected or aggrieved by agency action . . . .” 5 U.S.C.
`§ 702.
`
`Under the APA, a court must “hold unlawful and set aside agency action . . .
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`found to be . . . arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with
`law . . . .” Id. § 706(2)(A). An agency action 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. Assoc. v. State Farm Mutual Auto. Ins. Co.,
`463 U.S. 29, 43 (1983).
`Under the APA, a court must also “hold unlawful and set aside” any agency
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`action taken that is “in excess of statutory jurisdiction, authority, or limitations, or short of
`statutory right.” 5 U.S.C. § 706(2)(C).
`Finally, under the APA, a court shall also “hold unlawful and set aside” any
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`agency action that was promulgated “without observance of procedure required by law.” Id.
`§ 706(2)(D).
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`FACTS
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`Beta-Agonists
`Experior is part of the beta-adrenergic agonist/antagonist (“beta-agonist” or
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`“β-AA”) family. The β-AA family was first described more than 60 years ago and has been
`divided into three subtypes: β1, β2, and β3. Experior belongs to the beta 3-phenethanolamine
`adrenergic agonist/antagonist (“β3-AA”) subtype.
`Beta-agonists are widely used in meat production in the United States due to their
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`efficacy in increasing animal growth. For pigs alone, around 60-80% of those raised for food in
`the United States receive beta-agonists, amounting to tens of millions of animals each year.
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`CASE NO.
`COMPLAINT
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`Case 3:20-cv-03703-RS Document 1 Filed 06/04/20 Page 13 of 35
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`Beta-agonists shift dietary energy balance toward skeletal muscle growth as
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`opposed to fat deposition. Producers often feed beta-agonists to animals during the “finishing”
`stage of growth—the final period of weight gain before slaughter—to encourage a last-minute
`increase in muscle mass and overall carcass weight, increasing the profit margin for producers.
`Available research, including from FDA’s own files1, shows that beta-agonists
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`have substantial negative impacts on animal health, human health, and the environment.
`Because beta-receptors are spread widely throughout the body as part of the
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`sympathetic nervous system, a number of physiological side effects can manifest when these
`drugs are administered to animals.
`Beta-agonists induce increased heartbeat, relaxation of blood vessels and muscle,
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`and contraction of cardiac tissue. FDA scientists have found that beta-agonists are linked to
`cardiomyopathy in cows, a disease of the heart that makes it harder for the heart to pump blood
`to the rest of the body, and other “adverse effects” on the heart. FDA is also aware that
`beta-agonists are linked to fatal respiratory distress in cows, which often occurs in conjunction
`with heat stress, overheating, or dust inhalation due to dry conditions.
`Scientists have also linked beta-agonists to a number of behavioral changes in
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`animals that correspond to the physiological effects of the drug, including an increase in
`aggressiveness and a variety of adverse drug effects including hyperactivity, trembling, hoof
`loss, lameness, broken limbs, inability to walk, and fatigued cattle syndrome. These conditions
`make animals more difficult to handle, increasing the incidence of violence towards animals by
`handlers at feedlots and slaughterhouses, while also increasing the potential for handlers to be
`injured.
`Because Experior negatively influences animal behavior, it corresponds to an
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`increased risk to humans who work with them. The beta-agonist Zilpaterol, for example, was
`voluntarily withdrawn by its drug sponsor, Merck, because slaughterhouses throughout the
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`1 From 2013 to 2019 Plaintiff ALDF received voluminous FDA records related to beta-agonists
`as the result of litigation under the Freedom of Information Act. FDA had these records in its
`possession at the time it approved Experior.
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`CASE NO.
`COMPLAINT
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`Case 3:20-cv-03703-RS Document 1 Filed 06/04/20 Page 14 of 35
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`United States reported concerns about non-ambulatory, slow, and difficult-to-move cows, and
`cows with severely deteriorated hooves.
`FDA’s own files contain reports of adverse reactions to beta-agonists in workers
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`and producers in the animal agriculture industry, as well as reports of beta-agonist residues in
`meat harming consumers. FDA has received numerous complaints from workers and consumers
`who experienced nausea, dizziness, respiratory issues, and other serious medical conditions
`requiring treatment and hospitalization, all after either being directly exposed to or consuming
`meat from animals fed beta-agonists.
`FDA’s files also contain acknowledgements from its own scientists that humans
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`with compromised cardiovascular systems react adversely to beta-agonists, and in fact FDA
`scientists encouraged beta-agonist drug sponsors to investigate cardiac issues in further beta-
`agonist studies after tremors were seen in a pilot study. FDA scientists have also stated that beta-
`agonists’ “[e]ffects are not desirable for consumers of food containing residues of the drug.”
`Indeed, beta-agonists are banned or restricted in many other countries because of
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`human safety concerns. All European Union members, China, Japan, South Korea, and Russia
`are some of the 168 countries that prohibit or restrict ractopamine, a popular beta-agonist, in pig
`production. The European Food Safety Authority panel that banned the drug based its decision in
`part on the fact that its data could not support a conclusion that the drug is safe.
`Beta-agonists also harm the environme