Katana VentraIP

Virus-Serum-Toxin Act

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.[1] 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).[2]

U.S. Veterinary Biologics Establishment License: The operator of each establishment has to submit a written application to the Administrator for a license. Blank applications are available upon request from the . When a person runs more than one establishment, a separate application is required for each establishment. The person of the establishment who is interested in applying for a license must have a statement explaining the relationship between the applicant and the company. If there is a change in ownership, operation, location of establishment, or the license becomes expired, a new application must be filled out. Before the license can be issued by the Administrator, an inspection of the establishment will take place. The conditions, equipment, facilities, and methods used to prepare the biological products will be examined. The inspection will verify that the establishment meets all of the requirements. A license will not be issued unless the Administrator feels the establishment will use the products efficiently for all its intended purposes. They also must operate in compliance with VSTA. In addition, the applicant or person who is responsible for producing the biological product has to be qualified by education and/or experience. The establishment must state in written form that they will not use false advertisements concerning the biological product. Consumers cannot be misled or deceived.[3]

Animal and Plant Health Inspection Service

U.S. Veterinary Biological Product License: The operator of the establishment has to submit a written application to the Administrator to obtain a license for each biological product that will be prepared in the establishment. Along with the application, several documents must be attached. The first type of document includes least four copies of an Outline of Production. Second, at least three copies of test reports and research data necessary to establish purity, safety, potency, and efficacy of the product must be attached. Third, legends describing which facilities are going to prepare each fraction of product are required. The fourth document has to contain completed labels. Along with these labels, all of the advertising matter and information regarding all claims to be made on labels must be attached. Once received, the Office of Management and Budget will approve this application. Once approved, several things must appear on the license. The true name of the product and its code number must be listed. The date in which the license was issued must be shown. Restrictions will be involved with the use of the product, which might include limited distribution and supervised usage. Licensed individuals have the option to request specific restrictions on the product if it pertains to the protection and safety of domestic animals and/or public health. These requests must be written and sent to the Director, Center for Veterinary Biologics, Licensing and Policy Development. In the requests, the person must state why the restrictions are needed. Supporting documents for these requests may also be attached.

[3]

Controversy[edit]

The first case of bovine spongiform encephalopathy (BSE), or mad cow disease, in the U.S. was reported in December 2003 at a farm in the state of Washington. Since the cow was from Canada, USDA officials thought the American beef supply was safe. However, after Japan and fifty-two other countries banned U.S. beef, the USDA started a program to test half of the nation's 450,000 cows that could not walk. The program did not find any cases of mad cow disease until June 25, 2005. The cow was found to have originated from America, was first tested in November 2004, and was recommended to be retested. During this time, the Bush administration restored about one-third of U.S. beef exports through intense lobbying, but Japan, the biggest export market, continued to deny America's beef. After a while, Japan lifted part of its ban. They allowed meat only from the carcasses of young cows that have had their spinal cords, vertebrae, brains, and bone marrow removed. Eventually, Japan reenacted the ban after a shipment from the U.S. contained meat with the vertebrae still attached. This has caused speculation on whether the VSTA regulates testing for BSE in cows. Many people believe that Congress should pass legislation forcing the USDA to license BSE testing to ranchers and slaughterhouses, and it is possible to amend the VSTA to do so.[4][5]


After the first case of mad cow disease that was discovered, two more cases emerged. In 2005, the second instance was found in a cow in Texas, and the third was found in 2006 in a cow from Alabama. In 2012, this issue still remains a controversy. On April 24, 2012, the Department of Agriculture discovered a dairy cow in central California with mad cow disease. The USDA's chief veterinary officer, John Clifford, stated that the cow's meat did not enter the food supply. In addition to this, the carcass will be destroyed. The infected cow was found due to random sampling and is considered the fourth cow in the U.S. to be infected with BSE. This has caused the controversy to arise once again and speculation on whether the VSTA regulates testing for BSE in cows is still a hot topic to be discussed.[6]

Text of the Act

CRS Report for Congress: Agriculture: A Glossary of Terms, Programs, and Laws, 2005 Edition - Order Code 97-905

The Virus-Serum-Toxin Act - A Brief History and Analysis