U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
September 1998

Dear Member, FDA Foods Community:

Having now been Director of FDA's Center for Food Safety and Applied Nutrition (CFSAN) for six months, I wanted to provide you a "progress report" on the Center's recent program accomplishments as shown in the enclosure. Although a number of these accomplishments were nearly completed or in process when I arrived at CFSAN, I wanted you to see the high level of activity that has occurred in fulfillment of our public health mission.

Implementation of the President's Food Safety Initiative is the Center's top priority. In conjunction with other federal agencies and the states, we have improved our ability to rapidly identify, contain, and track causes of foodborne illness. We are implementing seafood HACCP, and have initiated possible expansion of HACCP to address identifiable hazards in the food supply when supported by the science. We are continuing to develop prevention and education programs that address risks throughout the "Farm to Table" food chain. And we are conducting research and risk assessments to support these initiatives.

The Center has made demonstrable progress in many other important program areas as well. For example, we have approved several significant food additive petitions. We are addressing health claims issues under both the Nutrition Labeling and Education Act of 1990 and the FDA Modernization Act of 1997. We are developing the regulatory framework for implementing the Dietary Supplement Health and Education Act of 1994. And we are actively engaged in international harmonization activities.

Looking ahead, we are currently in the process of conducting a comprehensive review of all Center programs to set priorities for the coming year. Throughout the priority-setting process, we will be asking the central question, "Where do we do the most good for consumers?" As a first step, we held a public meeting on June 24 and 25 to provide an opportunity for public input into program priorities. A summary of the input we received is available on our home page (www.cfsan.fda.gov.) We will incorporate that input as we complete our Fiscal Year 99 planning process. You can expect to hear more about Center priorities later this fall.

I hope this letter has been informative. I am very proud of the Center's accomplishments to date, and I look forward to working with you in the future.

Enclosure

Food Safety

A. Hazard Analysis and Critical Control Points (HACCP)

• Guidance on Seafood HACCP: Publication of the second edition of the "Fish & Fishery Products Hazards and Controls Guide" to assist seafood processors in the development of their HACCP plans.

• Seafood HACCP Implementation: Through August 15, 1998, conducted over 2000 inspections of domestic seafood processors. Issued several hundred untitled letters to seafood processors regarding ways to improve implementation of their HACCP programs.

• Juice HACCP: Publication of a proposed regulation to require processors of packaged fruit and vegetable juices to implement HACCP to prevent contamination of their products.

• HACCP at Retail: Initiation of a pilot HACCP food safety program in retail settings.

B. Produce Initiative

• Presidential Report: In conjunction with USDA, issued a report to the President on implementation of the produce initiative.

• Meetings on Produce: Held public meetings to solicit comment on the draft Good Agricultural Practices/Good Manufacturing Practices guidance document.

• Guidance: Publication of the proposed Good Agricultural Practices/Good Manufacturing Practices guidance document to assist produce growers and packers in minimizing food safety hazards .

• Sprouts: Met with industry representatives to discuss ongoing cooperative research on interventions to assure the safety of sprouts.

C. Additional Prevention and Education Efforts

• Juice Labeling: Publication of a final regulation requiring a warning on unprocessed, packaged fresh fruit and vegetable juices.

• Prevention Measures for Eggs: In conjunction with USDA, publication of an advanced notice of proposed rulemaking to ensure the safety of shell eggs.

• Food Code: Effective interactions with the Conference of Food Protection leading to agreements on revision of the Food Code.

• Educational Efforts: Continued efforts to educate consumers to practice safe food handling via the "Fight BAC" campaign.

• Cider: Conducted workshops in the midwest and northeast apple growing areas on juice safety targeted to small producers.

D. Outbreak Containment and Response

• DNA Fingerprinting: In conjunction with CDC and USDA, establishment of a new computer network and database system to permit DNA fingerprinting of pathogens to be compared nationwide.

• Outbreak Response: Responding to disease outbreaks, in conjunction with FDA's field offices, state and local officials, and other federal agencies, including Salmonella Agona in toasted oat cereal and E. coli O157:H7 in a variety of food products.

• Cyclospora in Raspberries: Two site visits to Guatemala in follow-up to last year's outbreak of cyclospora in raspberries.

E. Research and Risk Assessment

• Food Safety Research Plan: Development of a three-year research plan that outlines the microbiological and microbial risk assessment research that CFSAN will conduct to support the food safety initiative.

• Joint Research Plan for Produce: In collaboration with USDA and other federal agencies, developed a broad research plant o enhance the safety of fresh fruits and vegetables in the U.S.

• Interagency Consortium: Development of a Risk Assessment Consortium under the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a collaborative activity between FDA and the University of Maryland. The consortium, which includes participation from all federal agencies with responsibilities for food safety (i.e., FDA, CDC, USDA, and EPA), will coordinate and guide federal risk assessment research related to food safety.

• Risk Assessment Clearinghouse: Through the Risk Assessment Consortium, established a clearinghouse for data, methodology and research advances that are needed for assessment models .

• JIFSAN: Conducted scientific meetings on the role of risk assessment in food safety; dose-response modeling for foodborne pathogens; and the risks posed by transmissible spongiform encephalopathies (TSEs).

• Workshop on Packaging Materials: Held a workshop at the National Center for Food Safety and Technology (Moffett Center) to discuss cooperative research aimed at establishing the safety of packaging materials for use with irradiation.

Food Additives

• Irradiation: Approval of irradiation for use in red meat.

• Artificial Sweeteners: Approval of Sucralose and Acesulfame-K.

• Olestra: Comprehensive postmarket review of Olestra by the Food Advisory Committee.

• Antimicrobial Agent: Approval of chlorine dioxide, an antimicrobial agent for use in processing of produce.

• Labeling: Publication of a final rule on the prominence of labeling for irradiated products.

Health Claims

• Health Claims for Psyllium: Publication of a final rule providing for health claims on the association between soluble fiber from psyllium husk and reduced risk of coronary heart disease.

• "Healthy" Labeling: Publication of a final rule allowing use of the term "healthy" on the labels of certain frozen and canned fruits and vegetables and enriched cereal grain products.

• Guidance on Claims: Publication of a guidance document for industry on health and nutrient content claims based on an authoritative statement, in accordance with the FDA Modernization Act of 1997.

• Denial of Claims: Publication of interim final rules prohibiting nine health or nutrient content claims that were not appropriately based on an authoritative statement.

Dietary Supplements

• White House Report: Published response to recommendations in the White House Report on labeling of dietary supplements.

• Structure/Function Claims: Publication of a proposed rule on statements made for dietary supplements concerning the effect of the product on the structure or function of the body.

• Nutrition Labeling: Publication of a final rule revising nutrition labeling requirements for dietary supplements that contain liquid extracts.

Cosmetics

• FDA Linkages: Establishment of stronger linkages with FDA's Center for Drug Evaluation and Research related to cosmetics in order to make more effective use of limited resources.

International Activities

• Harmonization: Continued participation in international activities to ensure that international standards and guidelines are consistent with U.S. requirements.

(See updated accomplishments, February 1999)