	Background

Historically, the federal government has assumed primary responsibility for the management and testing for foreign animal diseases like bovine spongiform encephalopathy or BSE, commonly known as "mad cow disease." Following the first confirmed case of BSE in the United States, the U.S. Department of Agriculture (USDA) announced an enhanced BSE sampling and surveillance program designed to test more cattle in the targeted high-risk population with the assistance of designated state and university diagnostic laboratories across the country. USDA implemented the new program in June 2004, and uses USDA-approved "rapid" immunologic test kits. Responding to and anticipating concerns of foreign governments and domestic consumers about potential contamination of the U.S. beef supply, Creekstone Farms Premium Beef—a private specialty producer and processor of Black Angus Beef—sought approval from the USDA to conduct voluntary BSE rapid testing for all the cattle it processes under a "marketing" program. On April 8, 2004, the USDA rejected Creekstone's request stating that the test had been licensed only for animal health "surveillance" purposes and "the test as proposed by Creekstone would have implied a consumer safety aspect that is not scientifically warranted." On March 23, 2006, Creekstone filed a lawsuit against the USDA seeking, among other things, an injunction enjoining USDA from implementing or enforcing any prohibition on Creekstone acquiring or using USDA-approved BSE rapid test kits for purposes of routinely screening for BSE-infected cattle. The USDA's rejection of Creekstone's request to privately test all of its cattle for BSE with rapid test kits ignited a significant amount of debate among lawmakers and segments of the beef industry and ultimately resulted in the lawsuit discussed herein. At issue is whether the USDA's decision to reject Creekstone's request to test all of its animals for BSE was a valid agency action. This report analyzes the legal authority of the USDA to regulate the voluntary testing of 100% of a private company's animals with rapid test kits and the USDA's rejection of Creekstone's application to test for BSE all of the cattle it processes. This analysis examines some of the legal arguments that have or might be presented in the Creekstone lawsuit.
The positive identification of bovine spongiform encephalopathy or BSE, commonly known as "mad cow disease," in a Washington State cow in December of 2003 sparked a number of reactions from the federal government, the meat industry, and close to forty countries world-wide. The U.S. Department of Agriculture (USDA), for example, launched an extensive BSE sampling and surveillance program designed to test more high-risk cattle with the assistance of designated state and university diagnostic laboratories across the country. USDA implemented the new program in June of 2004, and uses USDA-approved "rapid" immunologic test kits.
Most countries, however, quickly banned the importation of United States beef following the announcement. In an effort to meet new consumer demand, some private slaughterers propose to test 100% of their cattle using USDA approved "rapid test" kits. For example, Creekstone Farms Premium Beef, a private specialty producer and processor of Black Angus Beef, sought approval from the USDA to conduct voluntary BSE rapid testing for all the cattle it processes in order to promote sales, especially exports. The USDA, however, rejected Creekstone's request primarily because the test had only been licensed for animal health "surveillance" purposes and "the test as proposed by Creekstone would have implied a consumer safety aspect that is not scientifically warranted."
The USDA's rejection of Creekstone's request to privately test all of its cattle for BSE ignited a significant amount of debate and resulted in the filing of a lawsuit by Creekstone on March 23, 2006, against the USDA. At issue is whether the USDA's decision to reject Creekstone's request to test all of its animals for BSE was a valid agency action. This report examines the legal authority of the USDA's Animal and Plant Health Protection Service to regulate all testing for BSE, particularly the voluntary testing of 100% of a private company's animals with rapid test kits and the USDA's recent rejection of Creekstone's application to test all of the cattle it processes for BSE. This analysis encompasses some of the legal arguments that have or might be presented in the Creekstone lawsuit.
This report does not discuss the possible role that the Food and Drug Administration may play in the regulation of BSE testing and surveillance. For information on the USDA and legislative activities relating to BSE, see CRS Report RL32199, Bovine Spongiform Encephalopathy (BSE, or "Mad Cow Disease"): Current and Proposed Safeguards, by [author name scrubbed] and [author name scrubbed]. This report will be updated as warranted.