Docket Management
Docket: 02N-0278 - Bioterrorism Preparedness; Prior Notice of Imported Food Shipments, Section 307
Comment Number: EC -27

Accepted - Volume 2

Comment Record
Commentor Mr. Duane Ekedahl Date/Time 2002-08-30 15:39:14
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 307 (Prior Notice of Imported Food Shipments) Members of the Pet Food Institute import a wide variety of raw materials for inclusion in their products. However, under the provisions of this law, the agency is required to seek a great deal of information on product shipments into the United States. This provision is clearly required to prevent the importation of items that may pose a threat to human and animal health. PFI would urge the agency to consider the following questions and comments when developing the rules for this section:  Will the FDA expand its current import inspection programs to allow for the importation of materials without disruption (24 hours and 7 days a week)? Without this service extension, it will be impossible to effectively coordinate the notifications required under the law and may cause severe business disruptions.  Will the FDA coordinate its inspection and notification requirements with the US Department of Agriculture’s Animal and Plant Health Inspection Service, the Customs Service, or, ultimately, a newly formed Department of Homeland Security, which may include some or all of these agencies? For example, imported pet food products currently require a certificate from APHIS. Under the rule, will the agency require an additional notice for an import such as this?  In the case of the Customs Service, will the agency attempt to integrate the FDA OASIS system with Customs Service databases to prevent the need for duplicative notifications? PFI would urge the agency to coordinate its databases, to the extent possible, with all existing Customs Service systems, including the Automated Broker Interface, to prevent the requirement of duplicative notifications and the associated delays and business disruptions.  When will the prior notification requirement specify the grower of a particular commodity? PFI believes the agency’s rules should make it clear that the importer of an article has no affirmative duty to determine the grower of that article unless it does so as a normal part of business.  Will the rules recognize the current system that recognizes pre-shipment inspection and testing conducted by US trading partners as a means to shorten the import notification time requirement?  PFI would urge the agency to consider reducing the minimum prior notice requirement. Under the law, the agency is required, if it fails to issue timely rules, to impose prior notice periods of at least eight hours and not more than five days. We would urge the agency to consider a shorter notification time, where practical, to allow the importation of highly perishable items, particularly from Canada and Mexico. For example, the importation of fish from Canadian ports can be negatively affected if it must be held at the border until a predetermined time period has elapsed. PFI believes the agency’s mandate under the law can best be served by increased cooperation with other federal and state officials already charged with controlling the importation of items which may or may not be under FDA’s regulatory authority. This coordination can be accomplished through a variety of means, and significant overlap of notice and inspection can be avoided by encouraging interagency cooperation. 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 -27