U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
February 1999

Dear Colleague, FDA Foods Community:

This month marks the completion of my first year as Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN). I have very much appreciated the support and feedback I have received from many of you, including your continuing interest in receiving up-to-date information on CFSAN activities. Within that spirit, I am pleased to enclose with this letter a summary of CFSAN accomplishments from February 1, 1998 – February 1, 1999. As you may recall, on September 11, 1998, I distributed a "progress report" highlighting our "recent" program accomplishments. The list enclosed with this letter is an update of that report. This year-end report contains many new items, and those new items are clearly identified by an asterisk. I am very proud of all that we have accomplished.

In particular, I would like to highlight: (1) Implementation of the President’s Food Safety Initiative (FSI) as our highest priority (e.g., seafood inspections; Good Agricultural Practices; and labeling for unpasteurized juice); (2) Focus on productivity and output (e.g., food additive petitions; health claims); and (3) Development, with public input, of the Center’s 1999 Program Priorities document.

I also want to bring you up-to-date on who will be filling key CFSAN leadership positions. Effective March 1, 1999, Janice Oliver will assume the role of Deputy Center Director, and as such, will have line management responsibility over the major program offices. Assisting Ms. Oliver and I on my senior management team will be: L. Robert Lake, Director of Regulations and Policy; Morris Potter, D.V.M. (formerly of CDC), Director of the Food Safety Initiative; Robert Buchanan, Ph.D. (formerly FSI lead scientist, and prior to that of USDA) as my Senior Science Advisor; and Juanita Wills, Director of Management Systems. I believe the breadth and experience of these five individuals, combined with the talent and expertise of CFSAN’s Office Directors, will serve the Center and the pubic very well. I believe that this management team also strengthens the Center’s foundation as a science-based regulatory agency.

In closing, I will say that this past year has truly been the most satisfying year of my 20 years at FDA, and I look forward to working with you in the future.

Program Priorities

• *     Stakeholder Input: Held a public meeting to solicit input from stakeholders on establishment of program priorities.

• *   "CFSAN 1999 Program Priorities:" Established an internal priority-setting process and developed CFSAN's priority workplan for 1999. A copy of the workplan is available on the CFSAN's home page (www.cfsan.fda.gov).

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: In calendar year 1998, completed goal to inspect virtually all domestic seafood processors (approximately 4000 firms). Issued untitled letters to seafood processors (nearly 70% of those inspected) regarding ways to improve implementation of their HACCP programs.

• *   Florida State Shellfish Program: In conjunction with the Interstate Shellfish Sanitation Conference, improved compliance with national Shellfish Sanitation Program control measures in selected Florida shellfish processors to ensure that shellfish are processed under sanitary conditions.

• 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.

• *   Scientific Workshops on 5-Log Reduction: Conducted two scientific workshops for industry representatives on measuring and validating the 5-log reduction in pathogenic microorganisms.

• 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 final 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.

• *   Small Entity Compliance Guide: Developed a guidance document entitled, "Warning and Notice Statement: Labeling of Juice Products Small Entity Compliance guide," which contained questions and answers on how to comply with the juice labeling regulation.

• *   Citrus Juices: Publication of a notice in the Federal Register announcing an accelerated plan for citrus juices to assure that industry achieves a 5-log reduction for pathogens in lieu of the labeling requirement.

• 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. Development of a public awareness campaign on the risk that unpasteurized or untreated fruit and vegetable juices may present to vulnerable populations.

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

• *   Food Safety Web Site: Established a new "gateway" web site (www.FoodSafety.gov) to help the public more readily find government food safety information.

• *   Foodborne Pathogenic Microorganisms and Natural Toxins Handbook ("Bad Bug Book"): Publication of a revised handbook that provides basic facts regarding foodborne microorganisms and natural toxins. The manual is available on the Center's home page (www.cfsan.fda.gov) as well as on CD-ROM through AOAC International.

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, Salmonella seftenberg in alfalfa sprouts, Vibrio parahaemolyticus in oysters, and E. coli O157:H7 in a variety of food products.

• *   Cyclospora in Raspberries: Conducted three site visits to Guatemala in follow-up to last year’s outbreak of cyclospora in raspberries, and worked with Guatemalan raspberry producers to develop a Model Plan of Excellence.

• *   Rapid Response Team: In conjunction with CDC and the Council of State and Territorial Epidemiologists, established a Rapid Assessment Team to provide quick review of epidemiological reports of foodborne illness.

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 plan to enhance the safety of fresh fruits and vegetables in the U.S.

• Interagency Consortium: Development of a Risk Assessment Consortium at 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 additional packaging materials for use with irradiation.

• *   Presidential Report: In conjunction with USDA, issued a report to the President on the proposed structure, operating principles, and goals of the Joint Institute for Food Safety Research (JIFSR).

• *   JIFSR: In conjunction with USDA, convened a public meeting to solicit input on establishment of JIFSR.

• *   Bacteriological Analytical Manual: Publication of a revised manual that reflects the preferred test methods to use in testing food for microbial pathogens.

• *   Methods/Technology Development:

  • Development of an improved technique that reduces the time it takes to detect and quantify harmful E. coli from 24 to 48 hours to within 30 minutes;

  • Development of an intervention technology to inactivate pathogens in certain packaged foods by use of high hyrdostatic pressure;

  • Development of methods that increase the speed and simplicity to detect ochratoxins in grains and emetic toxin produced by Bacillus cereus;

  • Development of the first method for detection of Norwalk virus in contaminated shellfish.

NOTE: A more complete compilation of FDA’s FY 98 accomplishments under the FSI may be found on our home page (www.cfsan.fda.gov).

Food Additives

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

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

• *   Antimicrobial Agents: Approval of two antimicrobial agents: chlorine dioxide in water to wash fruits and vegetables; and acidified solutions of sodium chlorite for use in processing red meat.

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

• *   GRAS Notifications: Completed review of eight GRAS notifications as part of a pilot program.

• *   Food Quality Protection Act: In conjunction with EPA, issued a notice clarifying jurisdiction over antimicrobials that are used in food or food-contact articles.

• *   Expedited Review: Implementation of new procedures to expedite the review of food additives that are intended to decrease the incidence of foodborne illnesses through their antimicrobial actions against human pathogens that may be present in food.

Health Claims/Labeling

• 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.

• *   Guidance on Nutrition Labeling: Publication of a guidance document for industry, "FDA Nutrition Labeling Manual – A Guide for Developing and Using Data Bases."

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

• *   Health Claims for Soy: Publication of a proposed rule providing for health claims on the association between soy protein and reduced risk of coronary heart disease.

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.

• *   "Per day" Nutrition Labeling: Publication of a proposed rule revising the nutrition labeling requirements for dietary supplements to allow companies to list the amount and daily value percent of their products’ ingredients on a "per day" basis.

• *   Health Claims: Publication of a proposed rule on health claims for dietary supplements based on an authoritative statement.

• *   Thirty-Day Notifications: Reviewed 504 30-day notifications from manufacturers who plan to use a structure/function claim on a particular product; issued 109 letters in response to such notifications. (FY 98 accomplishment)

• *   Seventy-five-Day Notifications: Reviewed 18 premarket notifications for supplements containing new dietary ingredients. (FY 98 accomplishment)

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.

• *   Voluntary Registration Program: Reactivation of the Voluntary Cosmetic Registration Program. (Jan. "99)

• *   Stakeholders Meeting: Held a public meeting to solicit input on priorities and strategies for the cosmetics program in light of funds provided by Congress for program restoration. (Jan. ’99)

International Activities

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

• *   Codex Alimentarius: Provided the U.S. Delegate or Alternate Delegate to 13 of 16 Codex Committees; participated in the development of 95 Codex food standards; and established the FDA Codex Management Group.

• *   SPS Activities: Actively participated as part of the U.S. delegations in all meetings of the World Trade Organization (WTO) Sanitary and Phytosanitary (SPS) Committee to assure that the WTO SPS Agreement will be administered and interpreted in a manner that will not undermine FDA statutes or ability to protect U.S. consumers; reviewed all briefs and oral arguments for dispute settlement of three SPS cases.

• *   European Commission, Quadrilateral and Trilateral Meetings: Participated in a number of bilateral meetings with the European Commission, quadrilateral meetings with counterparts from Australia, Canada, and New Zealand and Trilateral meetings with Canada and Mexico to share information on food safety activities and to harmonize approaches to the regulation of foods and cosmetics.

• *   International Visitors: Briefed more than 650 international visitors on CFSAN program activities and accomplishments.

Federal-State-Local Integration

• *   Fifty-State Meeting: Hosted a meeting of federal, state and local food safety officials to initiate development of a plan for a nationally integrated food safety system.

• *   Follow-up Meeting: As a follow-up to the 50-state meeting, convened a meeting of the six workgroups and the Coordinating Committee to elect chairpersons, identify short-term and long-term goals for each work group, and establish a timeline for completion of work group activities.

• *   Outreach: Met with consumer groups and industry representatives to solicit input on the development of a plan for a nationally integrated food safety system.

Scientific Publications

• *   Manuscripts and Abstracts: CFSAN-developed detection methods, research results and guidance were shared with the scientific community through publication of approximately 160 manuscripts and over 100 abstracts.

Additional Outreach

• *   Industry Outreach and Education: In conjunction with USDA and the Institute of Food Technologists, conducted food law and regulations seminars for industry; educated U.S. food establishments on the labeling of FDA-regulated products; in collaboration with the Mexican government, developed a seminar to assist Mexican food producers in the safe production of exported foods; educated the Japanese food ingredients industry on FSI.

• *   Consumer Inquiries: Responded to more than 50,000 calls from consumers to CFSAN’s toll-free Food Information Line and to more than 6000 electronic mail inquiries on a variety of food-related nutrition, safety, and labeling issues.