Docket Management
Docket: 02N-0278 - Bioterrorism Preparedness; Prior Notice of Imported Food Shipments, Section 307
Comment Number: EC -24

Accepted - Volume 2

Comment Record
Commentor Dr. Donna Garren Date/Time 2002-08-30 14:49:28
Organization United Fresh Fruit and Vegetable Association
Category Association

Comments for FDA General
1. General Comments Correction: The United Fresh Fruit & Vegetable Association is pleased to provide comments on the provisions of Title III, Subtitle A, Section 307 (Prior Notice of Imported Shipments) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act”) contained in Docket Number 02N-0278. United is a national trade association representing member growers, shippers, packers, processors, marketers and distributors of fresh produce in the United States. The terrorist attacks of September 11, 2001 have had a dramatic impact on almost every aspect of American life. In addition to the devastating human toll caused by the attacks themselves, the fear of future terrorist incidents has undermined the individual sense of safety and security that many Americans long have taken for granted. The financial fallout also has been severe and has resulted in increased pressure on the economy and risk to private enterprise from both real and imagined threats. The dramatic impact of these events has led to a new focus in public policy aimed at promoting greater safety and security and preventing terrorist action. As our members provide over 1,000 different fresh fruits and vegetables to American consumers from both domestic growers and around the world, we take seriously our responsibility for prevention, detection, and all necessary actions to protect consumers from intentional contamination of our products. We commend the U.S. Food and Drug Administration (FDA) for its leadership in working with the private sector, including our industry, to ensure that appropriate steps are in place to minimize the potential of terrorist action to contaminate foods. However, we must continue to stress that industry and government efforts can only reduce the risk of intentional contamination, not eliminate all risk. In any risk management system, one reaches a point of diminishing returns in reducing risk, versus increasing costs or taking steps unacceptable to society at large. Let us keep in mind the American food supply continues to be the safest in the world. Continuing to ensure the safety and security of fresh fruits and vegetables whether produced domestically or abroad is a top priority of the entire produce industry. Food security systems should be risk-based and recognize and respond to new risks as they arise, provide the same level of protection to consumers, whether produced domestically or abroad, efficiently steward new technologies to the market, and effectively educate and communicate to stakeholders throughout the supply chain. With this in mind, we have reservations about certain provisions of Section 307 (Prior Notice of Imported Shipments). Therefore, we want to include for the record some recommendations that will assist FDA in the development of new regulations associated with Section 307 of the Bioterrorism Act. We encourage FDA to issue regulations that allow flexibility and take into account the produce industry’s diversity of products and complexity of global production and distribution. Flexibility is critical in that many prescriptive recommendations would be inappropriate or not applicable to our diverse industry. Because of produce's unique characteristics and the diversity of our industry, we recommend that FDA consider exemptions from the prior notice requirement for certain highly perishable products. We feel confident that our industry can work with FDA to design a system that meets both bioterrorism and produce needs. We would caution the Secretary to be absolutely certain that there is strong evidence to support that a food is adulterated or presents a serious adverse health threat. We suggest this because consumers will turn away from a product that is potentially tainted. Generally, an entire commodity segment is damaged during a contamination event, not just an individual firm, and can result in a significant economic loss for the entire industry. It is important for the Secretary to keep in mind that the produce industry produces and markets highly perishable items and time is a very valuable commodity. Timely decision-making is critical to the viability of our industry. Also, we have reservations about the amendment to Section 301 making it a prohibited act to import an article of food in violation of these prior notification requirements. We encourage FDA to communicate clearly to consumers that a violation is due to a failure of a food company not to supply prior notification before importing a food shipment and not because of an inherent food safety or security risk. Lack of adequate communication may result in false food scares and undermine consumer confidence in the agency. The produce industry is committed to ensuring the security of its products. The industry is proud of the contribution it makes to the health of Americans by providing wholesome foods essential for good health. It is important to always consider that increasing the consumption of fresh fruits and vegetables is a critical component of public health, and that risk management steps are properly weighed with the public health impact on the cost and availability of fresh produce. Since September, United Fresh Fruit & Vegetable Association and its members have been actively assisting the FDA in better understanding the production, packing, processing and distribution of fresh produce and potential supply chain vulnerabilities. The produce industry strongly supports regulations based on sound scientific results that can help the industry enhance the safety and security of produce, enhance consumer confidence, and increase the consumption of fresh fruits and vegetables. Thank you for the opportunity to comment. We look forward to continuing to work together with the FDA on these important matters.

EC -24