STATEMENT OF SENATOR EDWARD M. KENNEDY ON DEVELOPING A COMPREHENSIVE RESPONSE TO FOOD SAFETY Senate Health, Education, Labor and Pensions Committee

(As Prepared for Delivery) The most basic duty of any government is to protect the safety of the people it serves. A recent report to the FDA Science Advisory Board raises troubling questions about this Administration’s ability to meet this basic responsibility, with regard to food safety and many other area where American families count on FDA to protect their health. And instead of improving matters, the White House is poised to make them worse by threatening to veto the very bill that funds FDA. The report’s conclusions could not be more stark or more shocking: “FDA does not have the capacity to ensure the safety of food for the nation...FDA's ability to provide its basic food system inspection, enforcement and rulemaking functions is severely eroded, as is its ability to respond to outbreaks in a timely manner and to develop and keep pace with the new regulatory science needed to prevent future problems." Every time American families go to the grocery store, they worry about the safety of the food they buy. Every time parents buy toys for their children, they worry if the paint is contaminated or the materials are defective. They ought to be able to count on FDA and other health agencies to stand guard for them, to use the latestand best science to protect them, and to stop at nothing to detect dangerous products. But the advisory committee report reveals that FDA’s promise to protect American families is too often an empty one, because of the starvation budgets and absent leadership that FDA has endured in recent years. The plain truth is that FDA doesn’t have the money it needs to do the job it has to do. If the problems revealed by the report were confined to food safety, they would be disturbing enough – but the study shows that the effectiveness of the entire agency has been eviscerated by neglect. The major findings of the report read like an indictment: “Finding #1: The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak. Finding #2: The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability. Finding #3: The FDA cannot fulfill its mission because its information technology infrastructure is inadequate." I am pleased that we are joined by Secretary Leavitt today, and I welcome him to our committee. I hope he will take this opportunity to explain to the American people how FDA has been allowed to reach this sorry state. I also look forward to a thorough examination of how to improve food safety. Even a brief review of recent food safety concerns must ring alarm bells in every community. Salmonella was found in domestic peanut butter. Botulism was found in chili. An adulterant from China in pet foods led to illness and deaths in cats and dogs. An E. coli outbreak in spinach from California last summer killed 3 and sickened more than 200 others. I don’t have to look far to see the threat from E. coli. On Cape Cod last month, we were told to boil our drinking water because it was contaminated with these dangerous bacteria. The Administration’s food safety plan offers recommendations on improving food safety, and I look forward to hearing Secretary Leavitt’s discussion of this proposal. However, many experts believe we ought to do far more, and I look forward to the views of our distinguished panel on this matter. Both the European Union and the Japanese have more robust food safety programs than we do, and we can learn from them. Most significantly, they have much stronger programs to police imported food, combining inspections in the country of origin and testing of imported foods. We should be able to do at least as well. We need to give FDA the tools it needs to identify food safety problems more quickly and respond more effectively. Most importantly, we need to focus on preventing outbreaks in food. Each part of the food industry must have an effective plan in place to prevent hazards in the food it makes and markets. Preventive controls aren’t new – and they work. FDA has had regulations in effect since 1973 to require safety processing for many canned foods. Because of these regulations, there are now virtually no problems with botulism in these foods. FDA issued regulations in 2001 to require safety processing for juices, after E. coli in apple juice killed or injured children. Most manufacturers now pasteurize their juice, which eliminates this contamination. Despite the effectiveness of these regulations, the Administration’s plan proposes to expand this authority only with major limits. Under the proposal, FDA will be able to impose preventive controls only for foods that have repeatedly been associated with serious adverse health consequences or death. Essentially, this provision is a requirement that people be injured or even killed before the FDA can act. Such a requirement undermines the basic goal of preventing illness. Every manufacturer should be required to implement effective, preventive controls. And we must give FDA the authority to enforce the requirement before people are injured – not make them wait until them damage is done. The HELP Committee worked together this year to reauthorize user fee programs that provide significant resources for FDA. We need to be similarly creative to meet the agency’s other pressing needs. It’s a privilege to work closely with Senator Enzi on this hearing, and I look forward to working with him and our committee colleagues to develop a response to food safety. I also look forward to working with our colleagues on the Agriculture committee, and I see that the Chairman of that committee, who is also a colleague on this committee, Senator Harkin, is here with us this morning. If Senator Enzi would be agreeable, I hope we might have the opportunity to hear from Senator Harkin at the conclusion of Senator Enzi’s remarks.

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