62 Agric Dec. 523

FEDERAL CROP INSURANCE ACT

COURT DECISION

TRUDY TYLER BELGARD, et vir, AND BELWISE AQUACULTURE SYSTEM, INC., v. USDA.

No. 03-289.

Filed October 14, 2003.

Cite as: 124 S.Ct. 413).

CLDAP.

Crop Loss Disaster Assistance Program.

Supreme Court of the United States

Petition for writ of certiorari to the United States Court of Appeals for the Fifth Circuit denied.

524

FEDERAL MEAT INSPECTION ACT

COURT DECISION

MICHAEL BAUR FARM SANCTUARY, INC. v. USDA.

Docket No. 02-6249.

Filed: December 16, 2003.

(Cite as: 352 F.3d 625).

FMIA - FSIS - Standing - BSE - Risk, exposure to enhanced – Risk, hypothetical –Injury-infact Concrete and particularized – Actual and eminent.

Although at the time of the pleading the risk of exposure to BSE in the United States food supply was hypothetical, Plaintiff, Bauer, alleged that the enhanced risk of death (no known cure or treatment) justified a cautious approach including mandatory testing of every animal exhibiting symptoms of "downed cattle." Bauer requested that meat products from "downed animals" be classified as "adulterated." FSIS argued that consensus of scientific literature indicated that BSE had not been detected in the US. and challenged Bauer's standing on the grounds that the perceived risk was simply speculative and based on a series of "hypothetical events." Court determined that at the pleading stage, enhanced risk of disease transmission may constitute injury-in-fact citing Thompson v. County of Franklin, 15 F. 3d 245, 248-49 and Public Citizen v. Foreman, 631 F. 2d 969,974 n.12. Court saw a tight connection between the type of injury alleged and the fundamental goals of the statute which Bauer sued. The dissent does not find that Bauer has sufficiently particularized “his potential for injury." (i.e. He could stop eating beef.)

United States Court of Appeals,

Second Circuit.

Pooler, Circuit Judge, filed dissenting opinion.

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

'While this case was under consideration, the nation's first bona fide case of BSE "mad cow disease" was discovered on December 9, 2004 in the state of Washington at the Moses Lake Meats slaughter house. The result was a condemnation of many tons of meat already in transit plus the outright ban of U.S. beef in several countries. - Editor

'The Honorable David N. Hurd, Judge of the United States District Court for the Northern District of New York, sitting by designation.

62 Agric. Dec. 524

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'. 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 BSEcontaminated 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

'Other animal TSEs include transmissible mink encephalopathy, feline spongiform encephalopathy, chronic wasting disease in deer and elk, and scrapie in sheep and goats. TSEs that affect humans include kuru, classic Greutzfeldt Jakob disease, variant Creutzfeldt Jakob disease, Gerstmann-Straussler-Scheinker syndrome, and fatal familial insomnia

of harm to survive a motion to dismiss, we vacate the judgment of the District Court and remand for further proceedings.

BACKGROUND

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 "adulterated2." 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

The FFDCA prohibits the manufacture, delivery, receipt, or introduction of adulterated food into interstate commerce. See 21 U.S.C. § 331.

62 Agric. Dec. 524

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*.

While the authors of the study acknowledged that "[s]o far, there is no evidence for the secondary transmission of BSE from [] resistant species to more susceptible species," they noted that "the results presented [in this study] would strongly favour a decision to stop feeding ruminant-derived products to all animal species. Additional experiments should be carried out to detect possible BSE infectivity in clinically normal BSE-exposed animal species."

4

Currently, the USDA classifies all downed livestock presented for slaughter as "U.S Suspects." See 9 C.F.R. § 301.2 (2003) (defining U.S. Suspects as livestock "suspected of being affected with a disease or condition which may require condemnation in whole or in part, when slaughtered, and [which] is subject to further examination by an inspector to determine its disposal"); 9 C.F.R. § 309.2(b) (2003) (providing that "[a]ll seriously crippled animals and animals commonly termed 'downers,' shall be identified as U.S. Suspects"). If upon inspection the downed animal shows signs of (continued...)