In public comments submitted yesterday, People for the Ethical Treatment of Animals (PETA) applauds the United States Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) for announcing its plans to allow firms to secure exemptions from the target animal batch safety tests (TABST) that have until now been required for each batch of veterinary biologics products, including live and inactivated vaccines. In draft memorandum 453, USDA states that CVB intends to consider TABST exemptions in line with recommendations in the TABST waiver guideline drafted by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), in which USDA participates.
Under this new policy, CVB will consider exemption requests for products based on the submission of a report that includes an assessment of products' safety performance without the need for the generation of new data. Following an exemption from TABST, annual summary reports for adverse events related to exempted products will be required to maintain the exemption.
After studies conducted by the Advisory Group on Alternatives to Animal Testing in Immunobiologicals (AGAATI) determined that decades of advancement in vaccine manufacturing had rendered TABST irrelevant for routine product testing, AGAATI recommended the immediate deletion of TABST requirements from European Pharmacopoeia monographs. Since the publication of this recommendation, PETA has worked to ensure the elimination of all remaining barriers to exemption from TABST. At the request of PETA and PETA U.K., greater oversight of the exemption process and the removal of fees for exemptions vastly increased the implementation of TABST waivers.
Based on experiences in the U.K., PETA has requested that USDA take a stronger role in encouraging complete implementation of TABST exemptions. Although USDA's plans to allow manufacturers to apply for exemptions is progressing in advance of the VICH guideline's completion, the agency's draft memorandum 453 nevertheless imposes restrictions on the exemption process that do not appear in the VICH draft guideline and for which scientific support has not been provided. Specifically, USDA intends to disqualify products containing Gram negative antigens from eligibility for TABST exemptions. PETA has called upon USDA to consider these products for TABST exemptions when they are able to meet the standard of sufficient existing pharmacovigilance and serial release data required for all other eligible products.
Copies of PETA's comments on draft memorandum 453 are available on request.