To: FDADockets@OHRM-MAIL@FDAOC Cc: ISMTP@FDA-OC-TRAINING@FDAOC["'Alan Vernon-kalkan'" <"Alan. Vernon"@effem.com>], ISMTP@FDA-OC-TRAINING@FDAOC["'Jerry May'" ], ISMTP@FDA-OC-TRAINING@FDAOC["'Ken Johannes'" ], ISMTP@FDA-OC-TRAINING@FDAOC["Ekedahl, Duane" ] From: "Cook, Nancy" Certify: Y Subject: Docket Number 98N-0339 Date: Friday, September 11, 1998 at 2:59:51 pm EDT Attached: None Food and Drug Administration Dockets Management Branch Room 1061, HFA-305 5630 Fishers Lane Rockville, MD 20852 RE: Docket Number 98N-0339 The Pet Food Institute represents the manufacturers of 95% of the commercially produced dog and cat food prepared in the US, a $9.5 billion dollar industry domestically, with an additional $1 billion in export sales. As such, our members are vitally interested in the continuation of a strong, well-respected program of government oversight to counteract those persons who would believe that pet food is not safe and healthful. The Institute appreciates the opportunity to comment on at least one segment of the request for information submitted by Federal Register Notice for comment. We have chosen to focus on question 3 of the 7 submitted. "How can FDA work with its partners to ensure that products-both domestic and foreign- produced and marketed by the regulated industry are of high quality and provide necessary consumer protection; and how can FDA best establish and sustain an effective, timely and science-based post-marketing surveillance system for reporting, monitoring, evaluating, and correcting problems associated with use/consumption of FDA-regulated products?" As the first step in achieving fulfillment of a strong program, we submit that the position of Pet Food Specialist should be filled as quickly as possible since it has been vacant for over nine months (adding to the burden of Center for Veterinary Medicine (CVM) staff who are already fully occupied), to provide more efficient and effective service to this major area of CVM oversight. It is crucial to the pet food industry that the person hired to fill this position be knowledgeable in all areas of pet nutrition, applicable regulations and of the industry. This hire is essential to the fair enforcement of compliance rules as well, since it serves as a major resource to the Compliance Division of CVM. Second, it is important to note that the "quality" of a product is determined by the user, and is not part of the CVM mission statement, which reads: The Center for Veterinary Medicine is a consumer protection organization. We foster public and animal health by approving safe and effective products for animals and by enforcing other applicable provisions of the Federal Food Drug and Cosmetic Act and other authorities. Therefore, a determination of "high quality" products as mentioned in the question is not a charge of the agency. Third, the members of the Pet Food Institute believe that FDA should uniformly enforce the existing regulations regarding safety with particular regard to those products made by companies or individuals which appear to make no attempt to comply with Federal regulations. The Pet Food Institute appreciates the opportunity to comment on these matters. Sincerely, Nancy K. Cook Director, Technical and Regulatory Affairs Pet Food Institute