Good Morning. I appreciate the opportunity to come to the 1996 LCI Annual Meeting and to speak with you today. I want to thank Ms. Nancy Robinson, Chairman of the LCI Livestock Identification Committee, for inviting me to speak.

My remarks will address FDA's regulatory position in regard to implantable electronic devices for use in animal identification. These products are mostly known as implantable EIDs or transponders. Following my remarks, Dr. Robert Brewer and Dr. John Weimers of USDA will expound on this issue.

Several companies have developed technology for these EID products. FDA is working with manufacturers of EID products to facilitate their availability.

FDA supports the development and use of animal identification products and believes that these products can produce benefits for livestock producers, the agriculture industry, regulatory agencies, and consumers.

Proper identification of animals at slaughter makes it possible to successfully trace back a slaughtered animal to its source. This trace back greatly facilitates FDA's investigations to determine the cause and responsibility when residues of drugs or chemical contaminants are found in edible tissue.

The easier determinations of cause and responsibility helps focus government and industry educational programs to achieve the greatest compliance in proper drug use. In the tissue residue violation program, we maintain a high priority on reducing the number of repeat violators. Better methods for animal identification makes it easier to identify a repeat violator and to take specific enforcement actions.

Since the early 1990's when FDA's Center for Veterinary Medicine staff first met with industry and representatives of other government agencies, FDA has determined that implantable EIDs are food additives under the Federal Food, Drug, and Cosmetic Act, because the implant may be placed in portions of the animal that are rendered and thus become part of animal feed.

This position has been public since January 22, 1991, when it was presented at the 1991 Annual Meeting of the National Cattlemen's Association.

FDA has received numerous inquiries from industry, government agencies, academia, and the public requesting clarification on how FDA regulates transponders for use in animal identification.

After careful review of its policies, including consultation with USDA, the Agency issued a CVM Update on January 17, 1996, announcing its updated regulatory position. This morning I would like to briefly discuss the CVM Update and a refinement of the policy that has occurred.

The CVM Update stated that FDA will continue to regulate implantable EID products as food additives. However, the Agency has decided to exercise enforcement discretion regarding the use of transponders, within defined conditions as specified in the CVM Update and summarized as follows:

. Transponders should not be implanted in a tissue that is normally consumed by humans.

. Transponders may be implanted in portions of the animal that are rendered provided that the manufacturer of the transponder submits to FDA/CVM, adequate safety information on each of the transponder models to be marketed. If, the safety concerns are satisfactorily addressed, the Agency will notify the manufacturer in writing that, as a matter of regulatory discretion, sale of the specific transponder model may take place without a food additive regulation.

. Data would not be required from firms marketing transponders solely for pet animals (e.g., dogs, cats, pet birds), including horses that will not be used for food purposes, and labora- tory animals. These products may be marketed without the submission of safety information to the Agency.

. Manufacturers of transponders must receive concurrence from USDA's Food Safety and Inspection Service as to the acceptability of the implantation site.

After the issuance of the January 17th policy, we were approached by USDA/FSIS concerning implantation site, since in some species, for example pigs, no inedible implantation site has being identified. That is, all pig portions may be used for food. The FDA policy, as then stated, would not allow implantation of EIDs in pigs.

As FDA and USDA share jurisdiction with respect to transponders, we also share the ultimate goal of assuring the safety of food derived from EID-implanted animals.

We have responded to USDA's Food Safety and Inspection Service that if systems and controls are developed at slaughter to prevent transponders from becoming a part of human food, then implantation in edible tissue would be acceptable.

Again, to satisfy human food safety concerns, FDA maintains that if such a site is available, transponders should be implanted in a tissue that is not normally consumed by humans. For species such as pigs, FDA has proposed that UDSA/FSIS take steps to assure that the EID implantation site is completely trimmed from the carcass.

With regard to regulatory status, transponders implanted in edible tissue are also regulated as food additives, since it is anticipated that the trimmed area containing the transponder will be rendered and ultimately used in animal feed. Thus, manufacturers of such transponders will be required to submit to FDA safety data adequate to assure that there are no human food safety concerns arising from the consumption of food products from animals that have consumed feed containing EID component material.

In the event of system failure resulting in a meat product containing a transponder or parts of one, it is likely the transponder will be considered a deleterious substance that causes the food to be adulterated under the Federal Food, Drug, and Cosmetic Act, and subject to FDA regulatory action. We would ordinarily not, however, consider such regulatory action unless asked to do so by FSIS if FSIS decides not to take action under its applicable regulations.

Our policy on the use of implantable EIDs will be subject to continuing review. We stand ready to work with USDA and others on this issue.