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April 16, 2004
This text contains Dr. Brackett's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.
Good Morning. It's a pleasure to be here today to talk about FDA's food safety and security programs. We certainly have a full plate of issues.
Food Safety is a real and compelling public health problem. Every year foodborne illness accounts for 76 million illnesses, 325,000 hospitalizations and 5,000 deaths. FDA has a long history ensuring the safety and nutritional quality of the food supply that goes back to the early 1900's with regulations addressing food sanitation and consumer deception.
Today, we are faced with new challenges and more complex issues. The focus has shifted from broad categories of hazards to specific contaminants. The tradition of ensuring the safety and nutritional quality of the food supply will be continued as we address the new food safety challenges before us.
First, let me stress that food safety and security are integrated goals. By building upon the Nation's core food safety and public health systems and expertise, while strengthening expertise and capabilities needed to address the terrorist threat, FDA is enhancing food security and is improving food safety in the process. The food safety and security system is comprehensive, addressing the full range of assessment, prevention, and response needs, throughout the food production and distribution chain. The system must be efficient and in the context of both safety and security, address the most significant threats first, whenever possible. The system is built on a solid foundation of a national partnership with other entities involved in food safety and security that fully integrates the assets of state, local and tribal governments, other federal agencies, and the private sector.
The possibility of food products being used as a vehicle for an attack is particularly worrisome because such an event potentially affects everyone in the United States. FDA must have the capability to assess and then reduce risks associated with unexpected and potentially widespread health and safety threats. In January 2004, the President signed Homeland Security Presidential Directive, commonly referred to as HSPD-9, establishing a national policy to defend the agriculture and food systems against terrorist attacks, major disasters, and other emergencies. FDA plays a key role in the implementation of this directive. FDA is working with USDA and other stakeholders to build upon and expand current monitoring and surveillance programs and working to fully coordinate surveillance and monitoring systems that track specific commodities and food. FDA is continuing its work with CDC, USDA, and the States to develop a nationwide laboratory network that integrates existing federal and state laboratory resources and utilizes standard diagnostic protocols and procedures. FDA is working to develop and enhance intelligence operations and analysis capabilities focusing on the agriculture, food and water sector and we are continuing our work related to vulnerability assessments of the food sectors. We are working with our partners to develop mitigation strategies to protect vulnerable critical nodes of production or processing and to develop recovery systems that could stabilize the food supply and rapidly remove and effectively dispose of contaminated products.
FDA has made great strides in implementing the food related provisions of the Bioterrorism Act of 2002. Last December, FDA published interim final rules for the Registration of Food Facilities and the Prior Notice of Imported Foods. These rules go a long way towards meeting a higher bar for food safety and security and provide critical new tools for FDA to identify potentially dangerous foods. The food facility registration and prior notice information allows FDA to more effectively target inspections and better coordinate its border activities with FDA's other food safety programs to ensure both the safety and security of our food supply.
FDA anticipates 7.1 million line entries of imported food this fiscal year. To manage this ever-increasing volume, we are using risk management strategies to achieve the greatest food protection with our limited resources. We are using information gathered about the life cycle of imported products to create risk profiles that allow us to focus our resources on products that present the greatest risk. While we cannot physically inspect every shipment, every shipment is electronically reviewed by FDA's OASIS system to determine if the shipment meets identified criteria for physical examination or sampling and analysis or warrants other review by FDA personnel. In addition, FDA has been actively working with the analysts at CBP's National Targeting Center to utilize their Automated Targeting System as an additional tool to enhance the Agency's ability to focus attention on those imported foods that may pose a serious threat to public health. FDA has expanded its presence at ports of entry. In the last two years, we have more than doubled the number of ports that have an FDA presence from 40 to 90 ports.
FDA plans to finalize, by the end of May 2004, the remaining two critical rules under the Bioterrorism Act. These rules deal with the establishment and maintenance of records related to food and the administrative detention of food shipments that could harm the health of humans or animals. FDA received more than 200 letters commenting on the recordkeeping proposed rule from both domestic and foreign persons, each of which raised multiple issues. In finalizing the rule, it is important that we take the time to address each of the comments submitted. FDA received more than 100 letters on the proposed administrative detention rule and we are considering each of these comments as well. Even though neither the recordkeeping nor administrative detention rules are final, many of the food security measures in the Bioterrorism Act are already in place. Some 198,000 facilities have registered. We are receiving prior notice of most shipments, and many persons in the food distribution network are keeping records.
Also on our plate is strengthening our "firewalls" against BSE transmission. FDA intends to ban from human food - including dietary supplements, and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA will also apply to food products that FDA regulates.
FDA will be issuing an interim final rule that will ban:
Finally, let me mention our efforts in revitalizing our nutrition program. Helping consumers improve their nutrition is an increasingly urgent part of the FDA mission. I am please to announce that on May 3rd Dr. Barbara Schneeman will be joining the CFSAN team as the Director for the Office of Nutritional Products, Labeling and Dietary Supplements. Dr. Schneeman brings with her a wealth of experience and leadership in nutritional issues. Dr. Schneeman comes to us from the University of California, Davis where she has served as a member of the faculty since 1976 and for the last three years she has served as the Associate Vice Provost for University Outreach.
FDA is focusing its nutrition efforts on improving the health of the public by empowering people in the many choices they make every day that affect their health. Better information will lead to better educated consumers and consumers who will choose to eat the right foods to best improve their health.
Last July, we announced the Consumer Health Information for Better Nutrition Initiative. This initiative is designed to encourage the kind of marketplace where healthy foods can compete readily among all other foods available; to foster research and better understanding of diet and health; and to protect consumers, and to help consumers protect themselves from misleading claims by producers of foods and dietary supplements about health benefits that are not supported by Science.
FDA issued final guidance implementing interim procedures that we are using to respond to qualified health claim petitions until the agency can promulgate regulations under notice-and-comment rulemaking. The guidance provides a linkage between the ranking of scientific evidence and the working of qualified health claims. We began accepting petitions under these interim procedures last September. We believe that the process for making science-based health claims when combined with our enforcement work will help people choose healthier products while protecting them from companies that make false or misleading claims. The process also creates an environment that encourages and rewards companies for helping develop foods that help consumers follow a healthy diet and reduce the problems of obesity and other chronic illness.
Obesity is a pervasive public health problem in the United States. Over 30% of all Americans are obese. To help confront the problem of obesity in the United States and to help consumers lead healthier lives through better nutrition, the Commissioner created the FDA Obesity Working Group and charged the group with preparing a report that outlines an action plan to cover the critical dimensions of the obesity problem from FDA's perspective and authorities. Last month the Obesity Working Group issued it's report. The recommendations are centered on the scientific fact that weight control is primarily a function of balance of calories eaten and calories expended on physical and metabolic activity. Therefore, the recommendations focus on a "calorie count" emphasis. We will be working diligently to begin implementation of many of these recommendations. These include encouraging manufacturers to take advantage of the flexibility in current regulations on serving sizes and label as a single-serving those food packages where the entire content of the package can reasonably be consumed at a single-eating occasion, issuing an advance notice of proposed rule making (ANPR) to solicit public comment on how to give more prominence to calories on the food label, and encouraging manufacturers to use appropriate comparative labeling statements that make it easier for consumers to make healthy substitutions.
In closing, I cannot emphasis enough the need for continued active dialogue with all of our stakeholders on the many public health issues before us. Working together we will ensure that Americans continue to enjoy a safe food supply.
Thank you for inviting me today to address our food safety and security efforts.
