Docket Management
Docket: 02N-0275 - Bioterrorism Preparedness; Administrative Detention, Section 303
Comment Number: EC -5

Accepted - Volume 2

Comment Record
Commentor Dr. Donna Garren Date/Time 2002-08-30 14:12:13
Organization United Fresh Fruit and Vegetable Association
Category Association

Comments for FDA General
1. General Comments The United Fresh Fruit & Vegetable Association is pleased to provide comments on the provisions of Title III, Subtitle A, Section 303 (Administrative Detention) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act”) contained in Docket Number 02N-0275. 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 303 (Administrative Detention). Therefore, we want to include for the record some recommendations that will assist FDA in the development of new regulations associated with Section 303 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. While we do not oppose the removal or detention of products when there is a reasonable belief by the Secretary that a food is adulterated or presents a serious adverse health threat. We do, however, have reservations concerning qualifications and authorities given to an “officer or qualified FDA employee” in determining if credible evidence exists that a food is adulterated or presents a serious adverse health threat. For an industry that has fallen victim to otherwise “qualified” federal and state employees who have wrongly accused commodities of potential contamination, we caution the Secretary to be absolutely certain that there is strong evidence to support adulteration claims because consumers will turn away from a product that is potentially tainted. We recommend strict requirements for intense training of officers and FDA employees that would be involved in the determination of potential adulteration or intentional contamination. Current training and qualification requirements would not be adequate to ensure commodities and/or food companies are not wrongly accused of contamination. We would support the Secretary in establishing regulations for expedited procedures for instituting detention action for perishable foods, such as fresh produce. 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. A detention period of 20-30 days could result in significant economic losses. 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 transfer an article of food in violation of a detention order or to remove or alter any required mark or label identifying the article as detained. We do not oppose this amendment, but we encourage FDA to communicate clearly to consumers that this is due to a failure of a food company not to comply with these detention requirements 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 -5