U.S. Department of Agriculture Issues Guidance Document on the Use of Humane Endpoints and Methods in Animal Testing of Biological Products

The U.S. Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) has issued new guidance on the use of humane endpoints and methods in animal testing of biological products. CVB Notice No. 12-12, issued May 25, 2012, includes specific guidance regarding the use of humane endpoints in biological products testing, including guidance on humane endpoints for the rabies challenge test. The guidance also strongly encourages the use of anesthesia for intracerebral inoculation of mice during rabies vaccine testing, and encourages the use of analgesics in animal studies and potency testing when it can be shown this does not affect the study outcome.

The new guidance incorporates recommendations for refinement of rabies vaccine testing made by participants at the October 2011 NICEATM–ICCVAM workshop on alternative methods for rabies vaccine potency testing. Information about the workshop is available on the NICEATM–ICCVAM website. A summary of the workshop is posted here.

The new guidance and other notices issued by the CVB are available on the USDA website.