Creekstone Farms Premium Beef, L.L.C v. Department of Agriculture

539 F.3d 492, 45 A.L.R. Fed. 2d 739, 383 U.S. App. D.C. 175, 2008 U.S. App. LEXIS 18535, 2008 WL 3980533
CourtCourt of Appeals for the D.C. Circuit
DecidedAugust 29, 2008
Docket07-5173, 07-5199
StatusPublished
Cited by14 cases

This text of 539 F.3d 492 (Creekstone Farms Premium Beef, L.L.C v. Department of Agriculture) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Creekstone Farms Premium Beef, L.L.C v. Department of Agriculture, 539 F.3d 492, 45 A.L.R. Fed. 2d 739, 383 U.S. App. D.C. 175, 2008 U.S. App. LEXIS 18535, 2008 WL 3980533 (D.C. Cir. 2008).

Opinions

Opinion for the court filed by Circuit Judge HENDERSON.

Concurring opinion filed by Circuit Judge ROGERS.

Dissenting opinion filed by Chief Judge SENTELLE.

KAREN LECRAFT HENDERSON, Circuit Judge:

Creekstone Farms Premium Beef, LLC (Creekstone) raises and slaughters for sale Black Angus cattle. In December 2003, many countries began to ban or severely limit importation of U.S. beef because bovine spongiform encephalopathy (BSE)— “mad cow disease” — had been found in one cow in Washington State. See U.S. Dep’t of Agrie., Publ’n No. LDP-M-143-01, An Economic Chronology of Bovine Spongi-form Encephalopathy in North America 4 (2006) (Economic Chronology). To counter the fears of beef importers as well as domestic consumers, Creekstone developed a plan to test for BSE each of the approximately 300,000 cattle it slaughters each year. Declaration of John D. Stewart ¶ 6 (July 13, 2006) (Stewart Deck). The United States Department of Agriculture (USDA), however, asserting authority under the Virus-Serum-Toxin Act, 21 U.S.C. §§ 151-59 (VSTA or Act), denied Creek-stone’s request to purchase or use a BSE test kit. Creekstone challenged the USDA’s action in the district court, alleging that two of USDA’s regulations are ultra vires under VSTA and that, even assuming the regulations are valid, they do not authorize USDA’s restriction on the sale/use of the BSE test kit. Creekstone also challenged USDA’s interpretation of another regulation. Both parties moved for summary judgment and the district court granted partial summary judgment to each party. 517 F.Supp.2d 8, 13-16 (D.D.C.2007). For the reasons explained below, we affirm in part and reverse in part.

I.

A. Statutory/Regulatory Background

The Congress enacted VSTA in 1913 following reports that farmers were being sold ineffective anti-hog cholera serum. [494]*494See Agriculture Appropriation Bill: Hearings Before the Senate Comm, on Agrie., 62d Cong. 23-24 (1913) (testimony of A.M. Farrington, Asst. Chief, Bureau of Animal Indus., USDA). The Act makes it “unlawful ... to prepare, sell, barter, or exchange ... or to ship or deliver for shipment ... any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product intended for use in the treatment of domestic animals.” 21 U.S.C. § 151 (emphasis added). To this end, VSTA requires that “any virus, serum, toxin, or analogous product manufactured within the United States and intended for use in the treatment of domestic animals ... [be] prepared, under and in compliance with regulations prescribed by the Secretary of Agriculture, at an establishment holding [a] license issued by the Secretary of Agriculture” (Secretary). Id. (emphasis added). In addition, VSTA makes it illegal to import “any virus, serum, toxin, or analogous product for use in the treatment of domestic animals” without a permit from the Secretary. Id. § 152. To implement the Act, the Secretary is authorized “to make and promulgate from time to time such rules and regulations as may be necessary to prevent the preparation, sale, barter, exchange, or shipment ... of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, or otherwise to carry out [VSTA].” Id. § 154 (emphasis added).1

USDA has promulgated several regulations implementing VSTA. One regulation under review provides that “[w]here the Administrator [of USDA’s Animal and Plant Health Inspection Service (APHIS) ] determines that the protection of domestic animals or the public health, interest, or safety, or both, necessitates restrictions on the use of a [biological] product, the product shall be subject to ... restrictions as ... prescribed on the license.” 9 C.F.R. § 102.5(d).2 The second regulation under review provides that “[n]o biological product shall be brought into the United States unless a permit has been issued for such product” by the APHIS Administrator. 9 C.F.R. § 104.1(a). “Biological products” include “all viruses, serums, toxins, ... or analogous products ... which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response.” 9 C.F.R. § 101.2 (emphasis added). “Analogous products” are defined, in relevant part, as “[substances ... which are intended for use in the treatment of animals through the detection or measurement of antigens, antibodies, nucleic acids, or immunity.” Id. § 101.2(2)(ii) (emphasis added). “Treatment” is defined as the “prevention, diagnosis, management, or cure of diseases of animals.” Id. § 101.2(3) (emphasis added).

B. Bovine Spongiform Encephalopathy

BSE is an invariably fatal neurological disease that causes degeneration of the cow’s central nervous system. See Bovine Spongiform Encephalopathy, 70 Fed.Reg. 460, 461 (Jan. 4, 2005). BSE is believed to be caused by a type of protein called a “prion.” Declaration of Lisa A. Ferguson ¶ 3 (Sept. 20, 2006) (Ferguson Deck). Prions exist naturally in the nerve cells of many animals and are believed to help [495]*495maintain normal cell function; however, the protein also exists in an abnormal form which causes BSE. Stanley B. Prusiner, Detecting Mad Cow Disease, Scientific American, July 2004, at 86 (Creekstone Mot. Summ. J. Ex. 3) (CX-3). BSE occurs when healthy cattle are fed the remains of an animal (ruminant) infected with abnormally formed prions. Ferguson Deck ¶ 3. As abnormal prions accumulate within the brain cells, they cause the cells to rupture, resulting in a loss of coordination and ultimately the death of the animal. See CX-3, at 88; Ferguson Deck ¶ 5. Prions that cause BSE in cattle can cause a similar disease in humans known as variant Cru-etzfeldt-Jakob Disease (vCJD). Ferguson Deck ¶ 7. Since 1986, approximately 190 people — 95% of whom resided in the United Kingdom — have died as a result of confirmed cases of vCJD. Id. It is believed that humans can contract vCJD by consuming BSE-contaminated beef or beef products. Id.

BSE was first diagnosed in the United Kingdom in 1986. Id. ¶ 4. Since then, more than 189,000 confirmed cases of BSE in cattle worldwide have been reported. Id. While almost all of the cases (95%) have occurred in the United Kingdom, BSE has been found in cattle raised in at least twenty-five other countries. Id. In 1989, USDA banned the importation of ruminant products from countries with known BSE-infected cattle. See 9 C.F.R. §§ 93.401, 94.18; Ferguson Deck ¶ 8. In 1990, APHIS began a surveillance program to determine the existence vel non

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539 F.3d 492, 45 A.L.R. Fed. 2d 739, 383 U.S. App. D.C. 175, 2008 U.S. App. LEXIS 18535, 2008 WL 3980533, Counsel Stack Legal Research, https://law.counselstack.com/opinion/creekstone-farms-premium-beef-llc-v-department-of-agriculture-cadc-2008.