March 14, 1997
UPDATED POLICY ON THE USE OF ANIMAL ELECTRONIC IDENTIFICATION PRODUCTS IN SWINE
In a CVM UPDATE dated January 17, 1996, FDA's Center for Veterinary Medicine (CVM) announced its regulatory policy regarding implantable electronic identification products (EIDs) for use in animal identification. CVM supports the development and use of animal identification products to benefit livestock producers, the agricultural industry, regulatory agencies, and consumers.
After further consideration, the Center has revised its policy that there is no acceptable implantation site for swine. This decision is based on discussions with USDA's Food Safety and Inspection Service (FSIS). CVM agrees that appropriate systems and controls administered at slaughter will prevent EIDs from becoming a part of human food, and concludes that implantation in edible tissue under these conditions is acceptable. For implantation in pigs, FDA accepts the FSIS plan to assure that the EID implantation site is completely trimmed from the tissue that will be processed for human food. EIDs implanted in edible swine tissue will still be regulated as animal food additives, because the trimmed area containing the EID may be rendered and used in animal feed. In some specific cases, CVM may exercise regulatory discretion and not take action against the use of a food additive that is not covered by a food additive regulation. The conditions for regulatory discretion were outlined in the January 17, 1996 release.
In the event of a system failure resulting in a meat product containing an EID or parts of one, it is likely that the EID would be considered a deleterious substance that causes the food to be adulterated under the Federal Food, Drug, and Cosmetic Act. Thus, the food would normally be subject to FDA regulatory action. CVM would ordinarily not, however, consider such regulatory action unless asked to do so by USDA/FSIS if FSIS decides not to take action under its applicable laws and regulations.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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