Baur v. Veneman, Docket No. 02-6249.

Citation352 F.3d 625
Decision Date16 December 2003
Docket NumberDocket No. 02-6249.
PartiesMichael BAUR, Plaintiff-Appellant, Farm Sanctuary, Inc., Plaintiff v. Ann M. VENEMAN, in her official capacity as Secretary, United States Department of Agriculture & United States Department of Agriculture, Defendants-Appellees.
CourtUnited States Courts of Appeals. United States Court of Appeals (2nd Circuit)

SHELDON EISENBERG, Bryan Cave LLP (Michael G. Biggers and Kira P. Watson, on the brief), Santa Monica, CA, for Plaintiff-Appellant.

EDWARD CHANG, Assistant United States Attorney (James B. Comey, United States Attorney for the Southern District of New York, Meredith E. Kotler, Assistant United States Attorney, of counsel), New York, NY, for Defendants-Appellees.

Before: STRAUB and POOLER, Circuit Judges, and HURD, District Judge.*

Judge POOLER dissents in a separate opinion.

STRAUB, Circuit Judge.

This appeal centers on a narrow issue of standing in the context of a category of progressive neurological diseases, Transmissible Spongiform Encephalopathies ("TSEs"), of which the most widely publicized example is Bovine Spongiform Encephalopathy ("BSE," commonly known as "mad cow" disease), a fatal neuro-degenerative disease that affects the central nervous system of adult cattle.1 Plaintiff Michael Baur ("Baur"), has filed suit to require defendants, Ann M. Veneman, Secretary of Agriculture, and the United States Department of Agriculture ("USDA") to ban the use of downed livestock as food for human consumption. "Downed" is an industry term used to describe animals that collapse for unknown reasons and are too ill to walk or stand prior to slaughter. Baur alleges that downed livestock are particularly likely to be infected with TSEs, as TSEs typically cause animals to lose coordination and the ability to stand upright.

Under current USDA regulations, downed livestock may be used for human consumption after passing a mandatory post-mortem inspection by a veterinary officer. Baur claims that this policy violates the Federal Meat Inspection Act ("FMIA"), 21 U.S.C. §§ 601-605, and the Federal Food, Drug, and Cosmetic Act ("FFDCA"), 21 U.S.C. §§ 301-399, and further alleges that the consumption of downed animals creates a serious risk of disease transmission — most specifically the risk that humans will contract a fatal form of TSE known as variant Creutzfeldt-Jacob disease ("vCJD") by eating BSE-contaminated beef products.

Without reaching the merits of Baur's suit, the District Court, (Naomi Reice Buchwald, Judge), granted defendants' motion to dismiss for lack of standing, concluding that Baur's exposure to meat products from downed livestock was insufficient to establish a cognizable Article III injury-in-fact. Focusing on Baur's inability to allege that BSE has ever been detected in the United States or that BSE-contaminated food products had ever been offered for sale in this country, the District Court reasoned that the alleged risk of disease transmission was too hypothetical and speculative to support standing. See Farm Sanctuary, Inc. v. Veneman, 212 F.Supp.2d 280, 282-84 (S.D.N.Y.2002). Because we conclude that exposure to an enhanced risk of disease transmission may qualify as injury-in-fact in consumer food and drug safety suits and further find that Baur has alleged a sufficiently credible risk of harm to survive a motion to dismiss, we vacate the judgment of the District Court and remand for further proceedings.


The underlying administrative challenge in this suit arises from a March 4, 1998 petition which Baur filed with the USDA and the Food and Drug Administration ("FDA"). Baur requested that the agencies immediately "label all downed cattle as adulterated" pursuant to the FFDCA, 21 U.S.C. § 342(a)(5), which provides that any food that is "in whole or part, the product of a diseased animal" shall be deemed "adulterated."2 Baur argued that downed cattle are classified as "diseased" according to the USDA's own regulations, see 9 C.F.R. § 301.2 (2003) (defining "dying, diseased, or disabled livestock" as including animals displaying a "lack of muscle coordination" or an "inability to walk normally or stand"), and therefore, necessarily fall within the FFDCA's definition of adulteration.

Because humans who consume meat products from BSE-infected cattle may contract vCJD, a fatal neurological disease for which there is no effective treatment or cure, Baur argued that exposure to downed cattle posed a significant health risk and that the elimination of downed cattle from the food stream was necessary to protect public health. In his petition Baur claimed that the British outbreak of mad cow disease had already "demonstrated the very real threat of human disease through exposure to BSE," — a threat made all the more serious by scientific research suggesting that downed cattle in the United States may already be infected with a unidentified variant of BSE.

Baur also argued that preventing the human consumption of downed cattle was necessary, because "current [BSE] surveillance efforts, including slaughterhouse inspection procedures," could provide only limited screening. Pointing out that the required "ante-mortem inspection of downed cattle commonly takes five minutes or less," and that "[i]t would be very difficult to identify central nervous system (CNS) symptoms in this amount of time," Baur noted that existing inspection procedures provided only a partial safeguard against disease transmission. "More importantly, although there are observable clinical signs of BSE," scientists believe that BSE has a long incubation period of up to eight years during which there may be no observable symptoms and as a result BSE "can only be confirmed following [post-mortem] histologic examination of the brain."

In May 1998, Baur submitted an amended petition, seeking to expand his original request for administrative action. Citing a recently published study which allegedly raised the possibility that BSE infectivity may persist in animals previously thought to be BSE-resistant, Richard Race and Bruce Chesboro, Scrapie Infectivity Found in Resistant Species, NATURE, Vol. 392, 770 (1998),3 Baur claimed that all downed livestock, and not just downed cattle, should be classified as adulterated under the FFDCA and banned for human consumption due to the risk of disease transmission.

The Food Safety and Inspection Service ("FSIS"), a division of the USDA, denied Baur's administrative petition on May 25, 1999, concluding that it was not required under the FFDCA "to remove all downed cattle without exception, from the nation's food supply." Contrary to Baur's interpretation of the applicable food safety statutes, FSIS stated that it was bound by the definition of adulteration set forth in the FMIA, and not the FFDCA, for all livestock presented for slaughter at a federally inspected slaughter establishment. FSIS argued that, unlike the FFDCA, the FMIA did not automatically classify all products from a diseased animal as adulterated. FSIS also explained that its regulations for downed livestock were consistent with the FMIA which permits the carcasses of diseased animals to be passed for human food if a FSIS veterinary officer determines that the carcass is safe for human consumption.4 In addition, FSIS disputed Baur's claim that all downed livestock should be classified as diseased pursuant to 9 C.F.R. § 301.2, pointing out that the regulation refers to both "diseased" as well as "disabled" livestock and noting that a disabled animal, suffering from a broken leg, would not require condemnation as a potential health threat.

Finally, FSIS defended the adequacy of current federal inspection policies, stating that: "It is not difficult to distinguish a recumbent cow ... affected with a cental nervous system (CNS) condition. If proper clinical observations are combined with an adequate history and appropriate laboratory test evaluations, a differential diagnosis is possible in the vast majority of cases." FSIS also disagreed with Baur's assessment of the potential risk of disease transmission from downed livestock, noting that:

[T]he consensus of the scientific literature is that BSE does not exist in the U.S. BSE has not been detected in this country, despite active surveillance efforts for several years. Since 1990, nearly 6,500 specimens, from animals in 43 states, have been laboratory tested by an ongoing BSE surveillance system in the U.S. No evidence of BSE (in the form of characteristic lesions) or related transmissible spongiform encephalopathies (TSE) has been seen. In addition, to prevent BSE-contaminated animals or animal products from entering the U.S., severe restrictions exist on the importation of live ruminants and ruminant products from countries where BSE is known to exist.

Following the denial of his petitions and the failure of subsequent discussions with the USDA, Baur filed suit in the District Court seeking judicial review of the USDA's decision under the Administrative Procedure Act ("APA"), 5 U.S.C. §§ 701 et seq. The complaint briefly summarizes the allegations made in Baur's prior petitions, specifically alleging that downed livestock are more likely to be affected with diseases such as TSEs, and that given the inherent limitations in current BSE testing capabilities, "it is simply impossible to determine with certainty whether a downed animal is infected with BSE" by relying on a slaughterhouse inspection scheme. Baur claims standing to pursue his APA claims as "a regular consumer of meat products who is concerned about eating adulterated meat." He alleges that "each time he eats meat he is at risk of contracting a food-borne illness such as vCJD," and is consequently "injured by the risk that he may consume meat that is the product of a downed animal, and by his apprehension and concern arising from this risk."

Defendants subsequently moved to dismiss Baur's complaint, arguing, inter...

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