Docket Management
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC -21

Accepted - Volume 2

Comment Record
Commentor Mr. Duane Ekedahl Date/Time 2002-08-30 15:35:36
Organization Pet Food Institute
Category Association

Comments for FDA General
Questions
1. General Comments On behalf of the members of the Pet Food Institute (PFI), thank you for the opportunity to present these preliminary comments on the Food and Drug Administration’s (FDA) efforts to develop regulations for implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL 107-88). PFI represents the manufacturers of commercial dog and cat food that produce approximately 97 percent of the dog and cat food sold in the United States. PFI’s membership includes national and multinational companies with a large variety of brands, smaller pet food makers who may only conduct business in one region of the country, and affiliated members that provide materials and services (ingredients, equipment, laboratory analysis) to the pet food industry. The following comments have, as agency personnel requested, been filed as separate documents for each section/docket number currently under review. This introductory text is the same for each comment document. The need for additional precautions to protect the United States from bioterror attacks is apparent. The events of September 11th have focused the attention of policymakers, government agencies and the public on the greater need for security here in the US. As a part of that need, Congress passed this law intended to bolster current protections and, in some instances, create new layers of protection over the food and feed supply. However, though its goals are laudable, there are numerous unintended consequences and important considerations that must be reviewed before the law is fully implemented. It is with those points in mind, PFI offers comments on the four sections currently in the rulemaking process. Where appropriate, we have also offered suggestions to rectify situations that might arise due to the unintended consequences we will describe. Nothing in these comments should be construed as a criticism of the important work currently underway to protect our nation and its food supply. PFI members fully support the efforts to bolster our security and maintain what is the envy of the world – the safest and most affordable food supply for all consumers. Section 305 (Registration of Facilities)  Members of the Pet Food Institute agree that it is necessary for the FDA to have complete information on facilities engaged in food production, distribution, or other related services. However, the complexity of registering thousands of facilities, coupled with the information technology challenges posed by such a task, should encourage the agency to permit firms to register once from their corporate headquarters. PFI would urge the agency to consider a system in which a firm can register all its manufacturing plants, distribution centers and other locations at one time, using one form. Each facility would be assigned its individual registration number but this centralized format would permit a more orderly flow of information to the agency in a shorter period of time.  In addition to this proposal, PFI would also request the agency take into consideration that additional problems associated with registering foreign entities associated with US firms. Under other provisions of this law, their activities are reported to the agency whenever materials are imported for use in the United States. Therefore, we would request the same provisions suggested above, centralized registration, apply to firms with operations located outside the United States.  The agency needs to provide clarification for the following terms described in the Act: “farm”, “warehouse”, and “agent in charge”. Precise definitions of these terms will permit affected firms to accurately determine which facilities require registration.  PFI would urge the agency to also consider an exemption under this section for facilities engaged in product research and development. Many of these facilities, including product development labs, are located outside the United States. By reducing the number of facilities that require registration, the agency can focus its efforts on those firms actually engaged in the production of materials for further processing or direct consumer purchase. On behalf of the members of the Pet Food Institute, thank you for taking our comments under consideration as you develop these important rules to protect our nation’s food and feed supply. We look forward to commenting on the proposed rule and stand ready to offer any additional information required by the agency.




EC -21