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Monday, December 1, 2008

FDA Reports Significant Progress in Protecting the Food Supply

The U.S. Food and Drug Administration today released a report on its implementation of the Food Protection Plan that was launched a year ago to protect both domestic and imported food from accidental and intentional contamination. The Plan, which outlines strategies for prevention, intervention and response, is designed to address food safety and food defense for both domestic and imported products and covers the full lifecycle of food, by encouraging the building of safety into every step of the food supply chain.

"Science and 21st century technologies help drive the FDA's efforts to transform our food safety efforts from the Food Protection Plan into a reality," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "Every day, the FDA is working with foreign countries, state and local governments, regulated industry and consumer groups to ensure the safety of the food supply. We also continue to work with members of Congress to achieve new authorities requested in the Food Protection Plan."

Listed below are the highlights of the agency's accomplishments in implementing the Food Protection Plan's three core strategies: The prevention of outbreaks of food-borne disease, and intervention and response if they occur:

PREVENTION

* The FDA is establishing offices in five regions that export food and other FDA-regulated products to the United States: China, India, Europe, Latin America, and the Middle East. The FDA has already hired staff for its offices in China and India.
* The FDA was part of a U.S. Department of Health and Human Services (HHS) delegation to China to address food safety issues in both countries and to share ideas to address global food safety. U.S. and Chinese government officials discussed recent outbreak of foodborne illness in the United States related to fresh produce as well as the melamine contamination of dairy products in China.
* The FDA released the CARVER self-assessment tool for industry, to minimize the risk of intentional contamination of food, and conducted training seminars for industry on how to use the tool.
* The FDA held a meeting of with more than 200 federal, state, local, tribal and territorial partners to address the challenges of protecting the nation's food supply.
* The FDA is hiring an International Notification Coordinator to manage enhanced information exchanges between the agency and foreign counterpart regulatory authorities.
* The FDA approved the use of irradiation of iceberg lettuce and spinach for the control of pathogens, such as Escherichia. coli, in or on those foods.
* The FDA developed methods to detect melamine and cyanuric acid in feed and feed ingredients.
* The FDA is using genetic analysis to identify hundreds of Salmonella strains from seafood imports. The analysis provides information to trace outbreaks of Salmonella outbreaks and implement surveillance programs to ensure food safety.

INTERVENTION

* The FDA completed inspections of 5,930 high-risk domestic food establishments during the Fiscal Year (FY) 2008.
* The FDA piloted the program for inspection and sampling of high-risk companies in Denver and Minneapolis during the Democratic and Republican National Conventions.
* A targeted, risk-based inspection of a canning facility in 2008 identified cans with viable Clostridium botulinum spores and a recall was initiated. The FDA initiated this inspection, along with inspections of other Low Acid Canned Food (LACF) manufacturers, following four cases of botulism in consumers in 2007. The FDA increased inspection efforts to ensure that manufacturers of all types of LACF products are adhering to applicable FDA requirements. These actions illustrate the need for companies to operate under adequate preventive control systems.
* The FDA issued "Draft Guidance for Industry on Voluntary Third-Party Certification Programs for Food and Feed." Docket FDA-2008-D-0381 is available for viewing at www.regulations.gov.
* The FDA has developed a rapid detection method that uses flow cytometry to identify E. coli and Salmonella in food, now in use in poultry-processing facilities to detect and prevent bacterial contamination during food processing.
* The FDA is expanding its database of adverse drug events to include adverse feed events, which will allow the agency to respond faster to outbreaks of feedborne disease in animals, contamination episodes, and/or product defects.
* The FDA and U.S. Customs and Border Protection jointly issued a final rule on Prior Notice of Imported Food Shipments, and an accompanying Compliance Policy Guide (CPG) on Oct. 31, 2008; the rule and CPG were published in the Federal Register on Nov. 7, 2008.

RESPONSE

* The FDA is working with industry and the public to identify best practices for tracing fresh produce throughout the supply chain.
* The FDA has enhanced the agency's ability to coordinate a comprehensive response to foodborne illness events by authoring tools used to track emergency response resources and other locations of interest.
* The FDA hired two emergency /complaint-response coordinators to improve its response to emergencies that involve animal feed, including pet food.
* Following the detection of melamine in infant formula and milk products from China, the FDA worked with its state and local counterparts to rapidly canvas over 2,100 vendors of Asian products to remove any Chinese infant formula from the market and to sample milk-derived Chinese products to check for melamine contamination. The FDA also provided regular updates on its Web site, advising consumers which products to avoid because of melamine contamination.
* The FDA held regular briefing calls for consumer organizations during the outbreak of Salmonella Saintpaul in the summer of 2008, and regularly updated a Web page that provided information on the investigation into the outbreak, and advised consumers how they could protect themselves and their families.
* The FDA has signed cooperative agreements with six U.S. states to form a Rapid Response Team to develop, implement, exercise, and integrate an all-hazards response capability for food and foodborne illness responses, to react more rapidly react to potential threats to our food supply.
* After reports from China of melamine-contaminated infant formula, the FDA worked with its state and local counterparts to quickly canvas over 2,100 Asian markets to remove any infant formula from China that might be available and to sample milk-derived products to check for melamine contamination.

The entire One-Year Summary of Progress under the Food Protection Plan is posted at www.fda.gov/oc/initiatives/advance/food/progressreport1108.html, and the Food Protection Plan is available at www.fda.gov/oc/initiatives/advance/food/plan.html.

The Food Protection Plan complements the Action Plan on Import Safety the President's Working Group On Import Safety unveiled one year ago to improve the safety of all imported products. HHS Secretary Mike Leavitt heads The Working Group. For additional information on the FDA's activities under the Action Plan for Import Safety, please visit: www.fda.gov/oc/initiatives/advance/imports/activities.html.

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