From: Herb Schultz [hschultz@mts.net] Sent: Monday, July 07, 2003 3:53 PM To: fdadockets@oc.fda.gov Subject: Recordkeeping, US Bioterrorism Act July 07, 2003 Recordkeeping, Docket No. 02N-0277 Dockets Management Branch, (HFA - 305) United States Food & Drug Adminstration, 5630 Fishers Lane, Room 1001, Rockville, Md 20852 e-mail: fdadockets@oc.fda.gov. By way of introduction, the Manitoba Division of the Animal Nutrition Association of Canada, ANAC, has been closely following the development of the regulations for the US Bioterrorism Act. Our views are that it has both constructive and uncertain aspects to it. If the regulations allow for the cross border movement of animal feed in times of crisis or apprehended threat, then Manitoba feed mills and their American livestock customers will be reassured as to its' intent. Conversely, should the requirements become confusing and capricious in their application then both the Manitoba feed industry and American livestock producers in states bordering Canada will suffer the economic consequences of the uncertainty. With regard to recordkeeping, Manitoba companies exporting medicated animal feed to American livestock producers already comply with US requirements under the FDA involving record keeping and cooperate with them to ensure audits are expedited whenever requested. Since these requirments are already embedded in our record keeping systems for feed safety purposes we quite respectfully ask that these be considered adequate and that additional, stand alone, recordkeeping systems not be introduced under the US Bioterrorism Act. As well, it would definitely be beneficial if the suitability of existing record keeping requirements were announced well ahead of the implementation deadline under the Bioterrorism Act. We take this view because the cross border flow of feed ingredients and the completed feed is a two way street where we see each other as associates and not rivals. Our membership includes companies headquartered in the USA and supplying product in a North American context, and of course, Canadian member companies have similar North American interests. Thank you for the opportunity to participate in your consultative process. Respectfully submitted by, Mr Doug Beckie, Chair Manitoba Division ______________________________________________________________________________ Manitoba Division, PO Box 23115, RPO McGillivray, Wpg, MB, R3T 5S3, tel (204) 261-7865,fax (204) 261-6319