The Virus-Serum-Toxin Act or VSTA (P.L. 430 of 1913, as amended; 21 U.S.C. 151-158) was United States Federal legislation designed to protect farmers and livestock raisers by regulating the quality of vaccines and point-of-care diagnostics for animals. Initially, the Virus-Serum-Toxin Act was created due to significant losses from unregulated manufacture and distribution of anti-hog cholera serum. The Act's intended purpose is to ensure the safe and efficient supply of animal vaccines and other biological products. The United States Secretary of Agriculture is responsible for licensing and regulating the manufacture, importation, and exportation of affected agents. The act and its applicable guidelines are managed by the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA).
History
The Virus-Serum-Toxin Act was enacted in 1913. During this time, a USDA official stated that the bill was crucial "to protect the farmer and stock raiser from improperly made and prepared serums, toxins, and viruses." After seven decades, the Act was amended in 1985 to address the effects of advancement, industrialization, and modernization in the field of agriculture. The Food Security Act of 1985 lists the specific amendments: (1) authorize USDA to regulate intrastate, as well as interstate, movement of biological products, (2) broaden the Secretary's authority to issue regulations, (3) enhance enforcement powers, and (4) recognize a congressional view that regulation is "necessary to prevent and eliminate burdens on commerce and to effectively regulate commerce." In 2002, the VSTA was one out of seven agricultural laws affected by the Homeland Security Act of 2002. This did not cause provisions within the law to change but only shifted certain functions from one department to another. In this case, border and import inspection functions were moved from USDA to the Department of Homeland Security. After the terrorist attacks that took place in America on September 11, 2001, Congress wanted to merge all of the major border inspection activities under the control of one department to make things easier and more efficient. Currently, the DHS manages the physical inspection of imports, but the USDA still has authority over VSTA regulations and policies. The DHS and USDA are required to cooperate with each other for proper regulation and inspection practice.
Provisions
It makes it unlawful for any person, firm or corporation to engage in the "preparation, sale, barter, exchange, or shipment" of "worthless, contaminated, dangerous or harmful" virus, serum, toxin, or analogous animal biologicals in interstate commerce. The Act provides for licensing of products and establishments, and requires permits for the importation of animal biologicals. Regulations require preparation of biologicals in accordance with an approved Outline of Production so as to meet prescribed test requirements for purity, safety, potency, and efficacy. Regulations also require approval of all labeling and claims to be made in advertising. Animal biologicals are subject to both the Federal Food, Drug, and Cosmetic Act and the VST Act. The USDA Animal and Plant Health Inspection Service (APHIS) enforces the VST Act.
Licenses issued by Administrator
It is required that every person who is trained to prepare biological products subject to the VSTA shall have an unexpired, unsuspended, and unrevoked U.S. Veterinary Biologics Establishment License and at least one unexpired, unsuspended, and unrevoked U.S. Veterinary Biological Product License issued by the Administrator to prepare a biological product. Applicants who apply for an establishment license must also apply for at least one product license. An establishment license will not be issued without a license allowing the production of a biological product in the establishment.