Docket Management
Docket: 02N-0275 - Bioterrorism Preparedness; Administrative Detention, Section 303
Comment Number: EC -8

Accepted - Volume 2

Comment Record
Commentor Mr. Duane Ekedahl Date/Time 2002-08-30 15:37:04
Organization Pet Food Institute
Category Association

Comments for FDA General
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 303 (Administrative Detention) PFI member companies import a wide variety of materials for use in dog and cat food products. Many of these materials are derived from animals raised for human food and are highly perishable. PFI supports the agency’s efforts to develop an expedited process for determining the disposition of perishable imported items that may pose a health threat.  We urge the agency not to overlook the need for an expedited process under this section to cover perishable feed ingredients. At public meetings held prior to this comment submission, this section was referred to primarily for the importation of fresh fruit and vegetables. The animal-derived ingredients imported by PFI members constitute a vital component in many pet food products. An expedited hearing process, should one of those ingredients be believed to pose a threat, is vital to prevent disruptions in pet food production and distribution.  In addition, we would ask the agency to provide clarification of the facility requirements provided in the Act. For example, what level of security is required to meet the definition of a “secure facility” for detained goods and who is responsible for providing that level of security?  Finally, PFI would request clarification on the standards the agency would use to determine if an act is “intentional” versus a possible accidental contamination of a product or ingredient. For example, without detailed knowledge of the source of a potential danger, how will the agency use its authority to prevent the transport, processing or sale of an article? 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 -8