FDA ProposalFrom: Pineau, Sandra [spinea@coair.com] Sent: Tuesday, July 08, 2003 5:50 PM To: 'fdadockets@oc.fda.gov' Subject: FDA Proposal July 8, 2003 Dockets Management Branch (HFA-305) U.S. Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 To whom it may concern: The following comments are being submitted in response to the FDA proposal of May 9, 2003 titled "Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. GENERAL The passenger airlines and railways have been the industries most directly affected by the terrorist attack on September 11, 2001. Despite the economic situation since that tragic day, we have responded by voluntarily taking unprecedented steps to assure the safety of the food we prepare and serve to the traveling public. We have hired food security professionals and consultants; we have taken steps to safeguard our premises; and we are carefully screening both our current employees and new hires. We are more careful about our sources of incoming products and now take special steps to assure the integrity of the carts of food boarded on aircraft. Now FDA is proposing a record keeping requirement that will bury our industry in a mountain of either paper or electronic data. Please reconsider the ramifications of these regulations on our industry. One flight is likely to include hundreds of individual foods from scores of different sources, representing many suppliers and there are thousands of flights every day from hundreds of airports across the country. What this proposal does is create a undue hardship for our industry in the name of making food more secure. Please remember that the situations that this proposal is attempting to prevent are hypothetical and have never occurred in the first 100 years of flight. This proposal should be modified to be significantly less burdensome or to exempt the catering business altogether. FDA has "tentatively concluded" that it is "burdensome" and "unnecessary" to require retail facilities to keep records of each individual recipient consumer. The draft proposal, therefore, excludes retail facilities from its requirements in Section 1.327(d)(1). A reasonable case can be made for including caterers in this "retail" exemption. Like retailers and restaurants (also exempted), caterers supplying interstate conveyances are preparing meals for direct consumption by the consumer. To regulate even-handedly, the maker of a sandwich whether it is to be served in a restaurant, is to be offered for sale in a vending machine, is to be delivered as carry-out, is to be on a hospital patient's tray, or is to be served on a train or airplane must be subject to the same set of rules. If restaurants and retailers are to be exempt, caterers should also be exempt. In summary, these proposed requirements are excessive and are unfairly being applied to our industry. We strongly urge the Secretary to reconsider this proposal as written, and withdraw or significantly modify it. Sincerely Sandra Pineau Sr. Director, Planning & Design Continental Airlines Q Chelsea Food Services Q (Work: 713-324-8781 ) Fax: 713-324-8797 : Email: spinea@coair.com _________________________________________________________________________ Visit continental.com. Check-in, choose your seat, print your boarding pass and earn 1,000 OnePass bonus miles each time you book a trip. http://www.continental.com