January 15, 2005


 Regulation of animal biologics challenged

Posted Jan. 1, 2005

The Food and Drug Administration could end up regulating animal biologics that decrease the shedding of bacteria that are pathogenic to humans but not to animals. According to the AVMA Council on Biologic and Therapeutic Agents, however, the Center for Veterinary Biologics, which is within the Department of Agriculture's Animal and Plant Health Inspection Service, is best-suited for the job. In the coming months, the AVMA will therefore encourage the Center for Veterinary Biologics to assume jurisdiction for the regulation of these animal biologics.

The matter came to the attention of the council when it learned that, because of jurisdictional issues, the USDA declined to review data for licensure of an Escherichia coli O157:H7 biologic under development that is administered to cattle to decrease the shedding of bacteria.

COBTA believes the USDA should handle licensure for these preharvest biologics that can be administered on the farm to decrease the number of bacteria on carcasses. The AVMA Executive Board voted to support the council's recommendation. APHIS-CVB has the expertise to evaluate biologic products, whereas the FDA-CVM, with its focus on drug approval, currently does not.

The USDA, with its Food Safety and Inspection Service, and its Pathogen Reduction/Hazard Analysis and Critical Control Points program, is the recognized regulatory agency in meat and poultry safety.