Docket Management
Docket: 02N-0277 - Bioterrorism Preparedness; Establishment and Maintenance of Records, Section 306
Comment Number: EC -19

Accepted - Volume 2

Comment Record
Commentor Mr. Duane Ekedahl Date/Time 2002-08-30 15:38:14
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 2000 (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 306 (Maintenance and Inspection of Records for Foods) As prescribed in the law, the Food and Drug Administration will issue rules requiring firms and establishments, other than farms and restaurants, to maintain records on all transactions to enable the prompt tracing of potentially hazardous materials.  PFI would urge the agency to allow a wide range of flexibility in what records are required under the rule and how they should be maintained. Since the intent of the law is to permit the agency to track food shipments forward to consumers and back to producers, many firms already posses detailed records indicating these transactions. PFI would request the agency rely on existing records (e.g. purchase orders, suppliers lists, invoices, etc.) whenever possible rather than imposing the additional cost and burden of new record keeping requirements.  PFI members rely on a wide variety of ingredient providers to make their products. Since the variety of ingredients may be provided by different suppliers, and pet food manufacturers may do business with suppliers based on availability, cost and/or geography, we urge the agency not to take a “one size fits all” regulatory approach and allow flexibility based on the size of firm and number of transactions that could potentially be affected by an act of terrorism.  Under the law, records relating to food recipes, research and other confidential business activities are not to be disclosed. PFI members request that product formulations for processing pet food and related products be considered “food recipes” under the agency’s rules. The formulations of these products are confidential and reflect decades of research and development. The release of these formulations would be financially devastating to the affected companies. In addition, as indicated in the legislation, the agency should make every effort to prevent the disclosure, either inadvertent or under the Freedom of Information Act (FOIA), of confidential business information. Since this record keeping is designed to aid in the protection of human and animal health, only those records necessary to accomplish this task (e.g. type of product, specific manufacturer, dates of manufacture, affected area, etc.) should be released.  In addition to the problems which could arise in the record keeping associated with the ingredients described above, PFI would also request clarification on the definitions of “farms” and “restaurants” that are considered exempt under the law. For example, animal shelters charged with caring for unwanted animals receive, hold and transport pet food products. Would establishments of this nature be required to maintain records, which in many instances would be difficult if not impossible since the pet food products may be donated and may not even be in original containers with manufacturer information? PFI would request that the agency expand, to the extent possible under the law, the list of exemptions. This comprehensive list would help to ensure that firms are completely aware of their responsibilities for record keeping if they are covered by the rule and that the agency could more readily assist firms with compliance rather than initiate premature enforcement actions.  As was discussed at a number of public meetings held on this Act, a commingled or mixed ingredients are of great concern to PFI members. For example, the pet food industry relies on ingredients sourced from grains, rendered meals and fats and other commodities. Because of the nature of these ingredients, many of which are sourced from numerous locations, record keeping of all the varieties of transactions leading the final product is virtually impossible. The legislation clearly indicates a business will not be responsible for maintaining records of transactions in which it did not participate. However, the “one up one down” nature of the recordkeeping requirement could have a negative impact on a business under this example if it were forced to trace the use of all ingredients. We would urge the agency to take into consideration the burden that would be imposed if detailed records were required for such “collective” ingredients.  In addition, PFI would request the agency set forth in its rule what constitutes a “transaction” under the law and when would that transaction trigger the requirement for recordkeeping. In other words, does title to an article begin the record keeping requirement, or is possession of an article sufficient to require record keeping? We would suggest possession of an article is the more appropriate requirement since the intent of the law is to quickly and efficiently protect public and animal health in the event of a bioterror event. In addition, 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 and invoke the record keeping requirements set forth in the Act? 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 -19