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." States and veterinarians have played a role in animal disease testing but usually with significant federal oversight. 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. The USDA's enhanced surveillance plan also obtains a random sample of normal, but older animals at slaughter. USDA implemented the new program in June 2004, and uses USDA-approved "rapid" immunologic test kits. Rapid tests are designed to determine the presence of abnormal BSE-related proteins in sampled brain tissue within a few hours—a dramatic difference from the international "gold standard" test for BSE: the immunohistochemistry test, which can take up to two weeks. Since the implementation of the new testing program, a BSE-infected U.S.-born cow was identified in Texas in June 2005 and in Alabama in March 2006. In July 2006, the USDA announced that it would soon end enhanced testing and transition to an ongoing program that tests approximately 40,000 cattle yearly. Some countries, like Japan, saw USDA's proposed sampling as inadequate and insisted that the United States test all of its cattle for the fatal disease at slaughter before it would allow the beef to enter its borders. Japan placed a ban on U.S. beef after the first case of BSE was diagnosed in Washington state in December of 2003, but announced in October 2004 that it would allow some U.S. beef to enter the country under an interim trade program. The Japanese did not finalize a decision to permit U.S. imports until December 2005; however, U.S. imports were again halted by the Japanese on January 20, 2006, when vertebral column bones (backbone is a prohibited material there) were found in several boxes of veal shipped by a New York processor. U.S. beef imports, which once accounted for 25% to 30% of Japanese beef consumption, resumed July 27, 2006. 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." In a June 1, 2004, letter to Creekstone, the USDA also stated that "allowing a company to use a BSE test in a private marketing program is inconsistent with USDA's mandate to ... maintain domestic and international confidence in U.S. cattle and beef products." 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. Creekstone filed a motion for summary judgment on July 15, 2006. The USDA responded and filed its own motion for summary judgment on September 22, 2006. In addition to responding to Creekstone's claims, the USDA argued that the case should be dismissed as moot because Japan has reopened its markets to U.S. beef imports. 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 USDA cites the Viruses, Serums, Toxins, Antitoxins, and Analogous Products Act (21 U.S.C. §§151-159) (hereinafter VSTA) and its applicable regulations as the source of authority for its regulation of animal testing and, more particularly, the licensing of rapid test kits. The VSTA was originally enacted in 1913 primarily in response to substantial losses being suffered by American hog raisers from the unregulated manufacture and distribution of anti-hog cholera serum. The stated purpose of the VSTA in 1913 was to prevent: the introduction into the United States of dangerous and worthless viruses, serums and analogous products for use in the treatment of domestic animals, some of which products may be the means of introducing disease not now known in the United States, and also for the purpose of controlling the use, by preventing the interstate shipment, of similar dangerous and worthless products that may be manufactured within the United States. The USDA found this legislation necessary "in order to protect the farmer and stock raiser from improperly made and prepared serums, toxins, and viruses." Congress amended the VSTA in the Food Security Act of 1985 ( P.L. 99-198 , Tit. XVII, §1768) to (1) authorize the USDA to license and regulate intra state movement of biological products, (2) broaden the Secretary's authority to issue regulations "to carry out the Act," (3) grant the agency enhanced enforcement powers, and (4) recognize a congressional finding that federal regulation was "necessary to prevent and eliminate burdens on commerce and to effectively regulate such commerce." The legislative history supporting the 1985 VSTA amendments reflects a congressional understanding of the need for "national uniform standards" in the preparation and sale of biological products. Except as permitted in the act, the VSTA makes it unlawful for any person to prepare, sell, barter, or exchange anywhere in the U.S., or to ship or deliver in or from the U.S., any dangerous or harmful virus, serum, toxin, or analogous product intended for use in the treatment of domestic animals. The VSTA further requires that a person who prepares, sells, barters, exchanges, or ships any virus, serum, toxin, or analogous product do so in compliance with USDA regulations through an establishment holding an unsuspended and unrevoked USDA license. The VSTA authorizes the Secretary to issue, suspend, and revoke licenses for the maintenance of establishments that prepare viruses, serums, toxins, or analogous products for use in the treatment of domestic animals. Pursuant to 21 U.S.C. §152, the VSTA also prohibits the importation of any virus, serum, toxin, or analogous product except under a permit from the Secretary of Agriculture. The Secretary of Agriculture is also authorized to make and promulgate rules and regulations as may be necessary to prevent the preparation, sale, barter, exchange, or shipment of a dangerous virus, serum, toxin, or analogous product for use in the treatment of domestic animals or otherwise to carry out the VSTA. Pursuant to this authority, the USDA, through the Animal and Plant Health Protection Service (APHIS), has promulgated a comprehensive set of regulations governing the licensing of viruses, serums, toxins, or analogous products (See 9 C.F.R. subchapter E, pts. 101 to 124). Regulations for the VSTA broadly categorize viruses, serums, toxins, or analogous products as "biological products" at any stage of production 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. A "biological product" includes but is not limited to: vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components , that are of natural or synthetic origin, or that are derived from synthesizing or altering various substances or components of substances such as microorganisms, genes or genetic sequences, carbohydrates, proteins, antigens, allergens, or antibodies. (italics added) "Treatment" under the regulations means the prevention, diagnosis, management, or cure of diseases of animals. "Prepare" or "preparation" is generally referred to as the manufacture or production of a biological product and has been defined as the steps and procedures used in the processing, testing, packaging, labeling, and storing of a biological product. With respect to licensing, the regulations require every person who "prepares" biological products subject to the VSTA to have a valid U.S. Veterinary Biologics Establishment License and at least one valid U.S. Veterinary Biological Product License. A USDA permit is also required for every person importing a biological product. Although the VSTA explicitly addresses the preparation, sale, barter, exchange and shipment only, USDA regulations (discussed below) authorize "use" and "distribution" restrictions in the public interest or for the protection of animals. The USDA's rejection of Creekstone's request to privately test all of its cattle for BSE with rapid test kits has sparked a considerable amount of controversy. 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. As such, we first examine how a rapid test kit might fall within APHIS's regulatory purview.