Docket Management
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC -14

Accepted - Volume 2

Comment Record
Commentor Mr. Bob Bauer Date/Time 2002-08-30 12:51:13
Organization Association of Food Industries
Category Association

Comments for FDA General
1. General Comments Docket No. 02N-0276: Comments on Registration, Public Health Security and Bioterrorism Preparedness and Response Act of 2002 President Bush signed Public Law No. 107-188 into law on June 12, 2002. The Association of Food Industries, Inc., an association of 300+ U.S. companies in the international food trade, commends FDA’s Center for Food Safety and Applied Nutrition for its wise decision to call for comments from interested parties regarding factors the agency should consider as it proceeds to draft the regulations implementing Public Law No. 107-188. AFI offers the following comments on implementation of the registration provisions of Public Law No. 107-188. Objective The purpose of registration requirements under the Public Health Security and Bioterrorism Preparedness and Response Act is to authorize the Secretary to compile an up-to-date list of relevant facilities to enable the Secretary to rapidly identify and contact potentially affected facilities in the context of an investigation of bioterrorism involving the food supply. The industry goal for rule-making by FDA on registration of food facilities is to give the agency the required information in a manner that suits the structure of the facility or corporation, which is registering. This can be done through a flexible, yet simple method, providing for electronic as well as a paper process. AFI offers the following suggestions relative to registration: · Establishment of a flexible definition of “entity” to allow companies to register as best suits their corporate structure. This would provide for the inclusion of one parent corporation registering all subsidiaries on a single registration or the registration of different divisions of a company separately. · Electronic submission should be acceptable provided authenticity and confidentiality can be assured. Paper submission should also be considered. · Registration of individual facilities should not be required. A corporation can register all its facilities on a single registration. · Imported food from an unregistered foreign facility should be held under conditions that maintain the product’s marketability. Once a registration is submitted on that facility, a number should be assigned immediately and the product allowed to move forward. · FDA should complete the rule-making on registration prior to the 18-month legislative requirement. If regulations are not made effective by that date, entities would be required to register in any event, but would need to amend registrations to comply with a final rule when made effective. Companies should be provided sufficient time to prepare registrations. Adjusting registrations based on a late released final rule would be burdensome to the food industry. AFI thanks FDA for the opportunity to submit these comments. Sincerely, Robert Bauer, President, Association of Food Industries

EC -14