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

Dear Colleague, FDA Foods Community:

This document summarizes the 1999 program priorities for FDA’s Center for Food Safety and Applied Nutrition (CFSAN). There are five points I would like to highlight:

1. Our 1999 program priorities are based on input we received at the June 24 and 25 public priority-setting meeting, as well as input generated internally during our Resource Planning, Prioritization and Allocation Process. As you will recall, throughout the priority-setting process, we focused on addressing the central question, "Where do we do the most good for consumers?"

2. Our 1999 program workplan implements the CFSAN-related priorities of our new Commissioner, Dr. Jane Henney: food safety, strengthening the Agency’s science base, and full implementation of the FDA Modernization Act (FDAMA). As you will see, food safety is the centerpiece of our 1999 workplan. Moreover, we have a discrete focus on enhancing our science base, and have committed to implementing foods-related provisions of FDAMA.

3. There are two lists of activities in most major sections of the document. The first list of priorities in each section, identified as the "A" list, are activities that we are committing to complete by the end of 1999. Activities on the "B" lists are those we plan to make progress on during the year, but may not complete. In addition, the Center has responsibility for many other important ongoing activities that are not identified in this document. This document addresses primarily those initiatives representing something new or different that we need to address in 1999.

4. In order to ensure that we continue to focus our efforts on the real public health issues, and that such issues are being properly addressed, we will review our program priorities every four months. Thus, if new information becomes available throughout the year that necessitates a change in our priorities, there will be a standard mechanism in place for consciously re-directing our efforts.

5. Finally, this workplan reflects my management philosophy of how to best match workload with available resources. When I became Director of CFSAN last February, I announced we would establish an open and participatory priority- setting process, and that we would identify a finite number of program priorities that we would commit to accomplishing effectively and in a timely way. (I have frequently described this as moving a finite number of "boulders" up and over the mountain top.)

   The converse is also true: that new activities not listed on the workplan are either not going to get done this year, or progress on them will be slower. Nevertheless, I firmly believe that this is the best way for the Center to marshal its resources and to accomplish those objectives that most benefit the American consumer.

We will try hard to fulfill the commitments in this workplan, and look forward to reporting to you on our accomplishments.

Sincerely, Joseph A. Levitt Director Center for Food Safety and Applied Nutrition

Executive Summary
1. Food Safety Initiative
   • Imports
   • Hazard Analysis and Critical Control Points (HACCP)
   • Produce Initiative
   • Additional Prevention Efforts
   • Surveillance and Outbreak Response
   • Research
   • Risk Assessment
   • Education
   • "B" List

2. Major Program Areas
   • Premarket Review of Food Ingredients
   • Nutrition, Health Claims and Labeling
   • Dietary Supplements
   • Chemical and Other Contaminants
   • Cosmetics

3. Cross-Cutting Areas
   • Science Base
   • Federal-State-Local International
   • Human Resources

The CFSAN 1999 Program Priorities document constitutes the Center’s priority workplan for 1999. The plan incorporates stakeholder input and implements CFSAN-related priorities of the new FDA Commissioner. The plan will be reviewed every four months and updated, as necessary.

This Executive Summary highlights those priorities. A full listing is provided in the body of the document itself.

Implementation of the President’s Food Safety Initiative (FSI) continues to be the Center’s top priority and forms the centerpiece of the Center’s 1999 workplan. Having laid a strong foundation for the FSI program in 1998, CFSAN will expand implementation efforts to target the highest risk areas of the food supply. Specific goals for 1999 include the following:

• Imports: Enhance follow-up and containment of foodborne disease outbreaks associated with imported food; increase surveillance of imported food overseas and at the border.

• HACCP: Continue to implement seafood HACCP; publish a final rule regarding HACCP for fruit and vegetable juices.

• Produce: Promote use of the Good Agriculture Practices/Good Manufacturing Practices guidance for produce; develop strategy to ensure safe production of sprouts.

• Additional Prevention Efforts: Implement accelerated plan for pathogen reduction in citrus juices; publish proposed rule for shell eggs; promote adoption of the Food Code by States.

• Domestic Surveillance and Outbreak Response: Continued enhancement of coordination between Federal, state and local agencies on follow-up and containment of interstate foodborne disease outbreaks.

• Research: Implement and update food safety research as outlined in the Center’s Three-Year Plan; consult with USDA on additional research needs; support the food safety program and support development of the Joint Institute for Food Safety Research.

• Risk Assessment: Implement and update risk assessment research as outlined in the Center’s Three-Year Plan; conduct specific risk assessments of Listeria in foods, Vibrio parahaemolyticus in molluscan shellfish, and methylmercury in seafood.

• Education: Educate consumers and retail handlers about safety precautions for shell eggs; target general food safety education efforts to school children and high risk populations.

Premarket Review of Food Ingredients: Implement procedures to expedite the review of food safety-related food additives; achieve GPRA performance goals for food and color additive petitions; finalize the premarket notification process for GRAS determinations; and develop procedures for the submission of notifications for food contact substances.

Nutrition, Health Claims and Labeling: Publish a proposed rule on nutrition labeling of trans fatty acids; meet statutory timeframes for review of infant formula notifications, health claims notifications, and health claim petitions; and publish final rules on infant formula GMP's.

Dietary Supplements: Complete current stage of rulemaking on ephedra; meet statutory timeframes for new dietary ingredient notifications; develop an overall strategy for achieving effective regulation of dietary supplements under the Dietary Supplement Health and Education Act; enhance 2-way communication with stakeholders.

Chemical and Other Contaminants: Establish a level for patulin in apples; publish pesticide monitoring data as required by the Pesticide Monitoring Improvements Act; and convene a workshop to consider all available risk assessment data on fumonisin.

Cosmetics: Complete risk assessments of Alpha Hydroxy Acids and diethanolamine; develop a plan, including stakeholder input, for restoring the Cosmetics program as provided in the FY 99 appropriations, including reinstatement of the Cosmetic Voluntary Reporting Program.

Science Base: Further develop the infrastructure of the Joint Institute for Food Safety and Applied Nutrition (JIFSAN); expand the capabilities of the National Center for Food Safety and Technology (Moffett Center); review CFSAN research to ensure that all projects are relevant to the Center’s mission and closely coupled to the Center’s priorities; identify ways to strengthen the Center’s scientific expertise across its regulatory programs.

Federal-State-Local: In collaboration with CDC, USDA, and state and local governments, develop a plan, with stakeholder input, for a nationally integrated food safety system. Strengthen effectiveness of cooperative programs covering milk, shellfish, and retail food safety.

International: Develop an affirmative agenda for CFSAN’s international program activities, including participation in Codex activities, equivalence determinations, and international compliance issues; finalize criteria for evaluating foreign food regulatory systems for equivalence.

Human Resources: Pursue initiatives to improve the quality of worklife for all CFSAN employees, including enhanced communication, ideas for new training opportunities, supporting the new Employee Worklife Network; begin planning for the future by identifying where gaps exist in scientific expertise and other human resource needs.

Imports

1. Imports: In conjunction with the Field, develop and initiate implementation of a comprehensive strategy to enhance the safety of imported food products. This strategy will include:
• Follow-up and containment of foodborne disease outbreaks associated with imported food.

• Increasing surveillance of imported food products at the borders.
  1. Targeting imported food at high risk of microbial contamination.
  2. Developing remedies to address repeat violators.

• Initiating education, outreach, and technical assistance to foreign countries on use of the Good Agricultural Practices/Good Manufacturing Practices guidance for produce.

• Evaluating food regulatory systems in foreign countries.

• Conducting 75 - 100 foreign inspections of food establishments that produce food products at high risk of microbial contamination.

Hazard Analysis and Critical Control Points (HACCP)

1. Seafood HACCP: In conjunction with the Field, continue to implement seafood HACCP:
• Conduct second year of annual inspections of domestic seafood processors, with re-inspection of all domestic processors who received an untitled letter or warning letter in 1998, as the highest priority.

• Develop and implement enforcement strategy for seafood processors who have significant problems upon re-inspections.

• Develop and implement, in collaboration with the Seafood HACCP Alliance, a renewed training program for seafood processors who have received untitled or warning letters.

• Meet/exceed FY ’99 Government Performance and Results Act (GPRA) goal to assure that by the end of CY 1999, 50 percent of the seafood industry is operating under appropriate HACCP systems.

• Develop a "transition" policy describing when scientific issues need to be resolved before FDA will take regulatory action against a processor that has deficiencies in their HACCP system.
2. Juice HACCP: Publish a final rule regarding HACCP for fruit and vegetable juices.
3. HACCP at Retail: Provide guidance, training and technical assistance to federal, state, and local governments and industry in applying HACCP at the retail level.

Produce Initiative

1. Good Agricultural Practices: Disseminate and promote use of the recently published Good Agricultural Practices/Good Manufacturing Practices
guidance document to assist the agriculture community in minimizing microbial hazards in fresh produce.
• Disseminate the guidance widely to domestic and foreign agriculture communities.

• In conjunction with USDA and States, promote use of the guidance to domestic and foreign agriculture communities.
2. Sprouts: Develop a strategy and initiate its implementation for assuring the industry use of practices to ensure safe production of sprouts and the control of pathogens.

Additional Prevention Efforts

1. Citrus Juices: Implement accelerated plan to assure that industry achieves a 5-log reduction for pathogens in lieu of labeling requirement.
2. Prevention Measures for Eggs:
• Publish proposed rule on refrigeration of shell eggs at retail and safe handling practices by consumers.

• In conjunction with USDA, prepare a status report on actions taken to enhance the safety of shell eggs and egg products, in accordance with the Appropriations Conference Report.
3. Food Code: Complete revisions to the Food Code and publish a notice of its availability in the Federal Register. Meet/exceed FY 99 GPRA goal to achieve adoption of the Food Code by 25 percent of States.

4. MOU with FSIS: Finalize and implement Memorandum of Understanding with the Food Safety and Inspection Service (FSIS) regarding food establishments under the jurisdiction of both FDA and FSIS.

5. Vibrio Vulnificus: Solicit public comment on citizen petition 98P-0504 requesting that FDA establish a performance standard for Vibrio vulnificus.

Surveillance and Outbreak Response

1. Outbreak Response: In conjunction with the Field, follow-up and containment of foodborne disease outbreaks associated with food.

2. Foodborne Outbreak Response Coordinating Group (FORCG): In conjunction with FORCG, enhance coordination of interstate outbreaks of foodborne illness between FDA, CDC, USDA, and States. Specific milestones for FORCG to accomplish in 1999 include:
   • Issuance of guidance on tracebacks for fresh fruits and vegetables.

   • Issuance of guidance on foodborne outbreak response and coordination.

   • Issuance of guidance on essential components of a state foodborne disease prevention and control program and checklists for outbreak coordination.

3. Listeria: In conjunction with CDC and the FoodNet sites, develop and conduct a case-control study of Listeria infections to guide control efforts.

4. Salmonella enteritidis: Revise strategy and follow-up on Salmonella enteritidis in eggs, including tracebacks and assistance to states.

Research

1. Food Safety Initiative Research: Implement and update research as outlined in the Center’s research plan, "Three-Year Plan for Research in Support of the National Food Safety Initiative and Produce and Imported Food Safety Initiative" (May 1998). A copy of this plan is available on the Center’s home page (www.cfsan.fda.gov).
2. Extramural Research: Continue to fund multi-year extramural grants initiated in FY 98.
3. Consultation with USDA: Consult with USDA to identify food safety research applicable to FDA-regulated products that can be conducted by USDA’s research agencies, including the $5 million for the Cooperative State Research, Education, and Extension Service (CSREES) identified in the FY 99 Agriculture Appropriations Bill.

4. Joint Institute for Food Safety Research (JIFSR): Support the development of JIFSR and participate in its implementation.

Risk Assessment

1. Risk Assessment Research: Implement and update risk assessment research as outlined in the Center’s three-year research plan.

2. Listeria: Conduct a risk assessment of Listeria in foods.
3. Vibrio Parahaemolyticus: Conduct a risk assessment of Vibrio parahaemolyticus in molluscan shellfish.
4. Methylmercury: Conduct a risk assessment of methylmercury in seafood.

Education

1. Shell Eggs: Educate consumers and retail handlers about safe storage and handling of shell eggs to reduce the incidence of illness from eggs contaminated with Salmonella enteritidis.

2. "Fight BAC!": In conjunction with the Public-Private Partnership for Food Safety, target food safety education efforts to school children and high risk populations -- i.e., the very young, the elderly, and those with impaired immune systems.
3. Food Safety Education Month: Participate in activities in recognition of Food Safety Month (September 1999).

1. Update guidance for FDA field personnel and regulated industry on answers to
frequently asked seafood HACCP questions.
2. Develop a HACCP "template" code of practice for fish products through the Codex international workgroup.

3. Foster farm egg quality assurance programs.

4. Disseminate the results of FSI research; prepare and submit for publication technical papers and general reviews; update pathogen detection methods in manuals; and provide courses on new food testing procedures to staff in the Field, and staff in other federal agencies.

5. Finalize the charter for, and initiate implementation of, the Risk Assessment Consortium, a collaborative activity involving all federal agencies with responsibilities for food safety -- FDA, CDC, USDA, NIH, and EPA.
6. Working with the advice of the Risk Assessment Consortium, develop the systems component and the data modeling component of the Risk Assessment Clearinghouse based at the Joint Institute for Food Safety and Applied Nutrition (JIFSAN).
7. In conjunction with USDA, develop and implement an Information Network to enhance availability of food safety-related information and publications.

Premarket Review of Food Ingredients

1. Expedited Review: Implement 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.
2. Food and Color Additives: Meet/exceed FY 99 GPRA performance goals:
• By the end of FY 99, complete reviews of 30% of food and color additive petitions within 360 days.

• By the end of FY 99, reduce the number of overdue food and color additive petitions (i.e., those under review for more than 360 days) to 30% of those petitions under review.
3. GRAS Determinations: Publish a final rule creating a premarket notification process for independent GRAS determinations (GPRA goal).
4. Indirect Food Additives: Develop procedures for the industry on the submission of premarket notifications for food contact substances, and an estimate of the annual cost of carrying out the notification program, in accordance with section 309 of FDAMA and the FY 99 budget appropriation.
5. Irradiation Labeling: Publish an advanced notice of proposed rulemaking to solicit comments on whether revisions to the current irradiation labeling requirements are needed and, if so, what form such revisions might take, in accordance with the FDAMA Conference Committee Report.

6. Food Quality Protection Act: Develop a guidance document to clarify FDA’s jurisdiction over antimicrobials used in or on food in light of enactment of the Food Quality Protection Act of 1996 (FQPA) and the Antimicrobial Regulation Technical Corrections Act of 1998 (ARTCA).

1. Investigate additional procedures to expedite the lawful use of food additives that are expected to have a significant impact on food safety by virtue of their antimicrobial action against human pathogens that may be present in food.
2. Identify efficiencies/streamlining mechanisms for the food additive review process that do not compromise the quality of the review.
3. Develop a strategy regarding the use of bromates in baking products.

4. Complete an evaluation of the safety issues raised in citizen petition 98P-0724 concerning Cochineal extract and carmine color additives.

5. Complete revision of two chapters of the new edition of the "Redbook," "Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Foods."
6. Develop a Federal Register notice addressing the labeling requirements for olestra-containing products that takes into account advice from the June 1998 Food Advisory Committee meeting.
7. Develop guidance for the industry on the safety assessment of four types of food ingredients (enzymes, proteins, fiber, and lipids).

Nutrition, Health Claims and Labeling

1. Trans Fatty Acids: Publish a proposed rule on nutrition labeling of trans fatty acids in food.
2. Meet Premarket Review Statutory Timeframes:
   • Review premarket notifications for new infant formulas within 90 days.

   • Review nutrient content/health claim notifications based on an authoritative statement within 120 days, in accordance with sections 303 and 304 of FDAMA.

   • Review nutrient content/health claim petitions and if appropriate, file within 100 days of submission; publish a proposed rule authorizing such a claim within 90 days of the filing date; publish a final rule within 540 days from the date of submission.

3. Infant Formula: Publish final rules on infant formula GMP’s and quality control procedures.

4. Citizen Petition: Respond to citizen petition 98P-0968 regarding the labeling of Surimi, in accordance with the Appropriations Conference Report.

5. Food Regulatory Report: Submit a report to Congress, in accordance with the Senate Appropriations Report, regarding the Agency’s performance on various applications, notifications, submissions, petitions, and requests for advisory opinions.

1. Publish a proposed rule establishing criteria for filing and decisionmaking on nutrient content/health claim notifications based on an authoritative statement.
2. In response to citizen petitions 94P-0390 and 95P-0241, publish a final rule amending the regulations on nutrient content claims and health claims to provide additional flexibility in the use of these claims on food products.

3. In conjunction with the Field, establish a pilot enforcement program directed at consumer deception on food labeling.

4. Initiate a public process regarding the most appropriate scientific and regulatory framework for structure/function claims on conventional foods.

Dietary Supplements

1. Ephedra: Complete current stage of rulemaking addressing dietary supplements that contain ephedrine alkaloids.
2. New Dietary Ingredients: Review premarket notifications for supplements containing new dietary ingredients within statutory timeframes (75 days).
3. Nutrient Content/Health Claims: Publish a proposed rule on the applicability to dietary supplements of the FDA Modernization Act provisions on nutrient content/health claim notifications based on an authoritative statement.

4. Overall Strategy: In conjunction with other involved Agency units, and providing an opportunity for stakeholder input, develop an overall strategy for achieving effective regulation of dietary supplements under the Dietary Supplement Health and Education Act (DSHEA). The strategy shall address all elements of the dietary supplement program, including:
   • boundaries between a dietary supplement and a conventional food, between a dietary supplement and a drug, and between a dietary supplement and a cosmetic product;
   • claims;
   • good manufacturing practices;
   • adverse event reporting, review, and follow-up;
   • laboratory capability;
   • research needs;
   • enforcement; and
   • resource needs.

5. Stakeholder Outreach: In addition to obtaining input on overall strategy development, enhance outreach efforts to stakeholders to assure effective communication.

6. Citizen Petition: In conjunction with ORA, respond to citizen petition 98P-0509 regarding FDA’s jurisdiction over publications associated with dietary supplements.

1. Elevate the priority of field assignments on dietary supplements, such as dieter’s teas and folic acid-containing products.

Chemical and Other Contaminants

1. Patulin: Develop a compliance policy guide establishing a level for patulin found in apples used to make juice.
2. Pesticide Monitoring Improvements Act (PMIA): Publish on the internet FDA’s pesticide monitoring data and summary information as required by PMIA.
3. Total Diet Study Workshop: In conjunction with the Field, conduct an International Total Diet Study Workshop to assist foreign countries in establishing a dietary monitoring system for contaminants, pesticides, and nutritional elements in their food supplies.

4. Fumonisin: In collaboration with NTP and NCTR, convene an international workshop to consider all available risk assessment data on fumonisin.

1. Develop a comprehensive compliance policy guide for filth in food -- including, egregious filth and avoidable filth in food.
2. Develop a compliance policy guide for hard sharp objects in food.
3. Develop a guidance document for industry involved in the manufacture of lead-containing decoration on the lip and rim areas of glassware that may qualify as a food additive.

4. Develop a compliance policy guide for sampling and analyzing fresh and frozen raw
shrimp for decomposition.
5. Revise Compliance Policy Guide 575.100, Pesticide Residues in Food and Feed, to
make the guide consistent with the Food Quality Protection Act of 1996.
6. Establish an Elemental Analysis Manual, and develop the sections for the most important methods of analysis of foods and foodware.

Cosmetics

1. Alpha Hydroxy Acids: Complete assessment of Alpha Hydroxy Acids to determine public health risk and regulatory category.
2. Diethanolamine: Complete a risk assessment for diethanolamine to determine if this cosmetic ingredient presents a health hazard under expected conditions of use.
3. Voluntary Reporting: Reinstate the Cosmetic Voluntary Reporting Program.

4. Program Restoration: Develop and implement a plan, with stakeholder input, for restoring $2.5 million to the cosmetics program, as provided in the FY 99 Appropriations.

Science Base (See Also: FSI Research in Part I)

1. Joint Institute for Food Safety and Applied Nutrition (JIFSAN): Further develop the infrastructure of JIFSAN, focusing on the food safety initiative, risk assessment, and dietary supplement research.
2. National Center for Food Safety and Technology (Moffett Center): Expand the capabilities of NCFST to initiate and implement academic/industry/government task forces to rapidly develop, evaluate, and transfer technologies that control emerging food safety problems.
3. Review and Update FSI Research: Update the Center’s FSI research plan for the coming three years (1999 – 2001) to ensure that the research projects the Center is performing provide a strong scientific basis for our regulatory mission under FSI.
4. Review Non-FSI Research: Review non-FSI research being conducted within CFSAN to ensure that all projects are relevant to the Center’s regulatory mission and closely coupled to the Center’s priorities in those respective areas.
5. Peer Review: In consultation with FDA’s Office of Science, conduct an external review of the Center’s research program and its administration. This strategic review will assess whether the research program is well integrated, responsive to regulatory needs and administered effectively and efficiently.

6. Regulatory Scientists: Identify ways to strengthen the Center’s scientific expertise
across its regulatory programs, including the premarket review functions conducted by the Center’s scientific review and research staff. This includes identifying training needs, gaps in expertise that need to be filled, and mechanisms to utilize outside scientific experts.

Federal-State-Local

1. Integrated Food Safety System: In collaboration with CDC, USDA, and state and local governments, develop a plan for a nationally integrated food safety system that would enhance the level of consumer protection provided by the current system. Specific milestones in 1999 to accomplish development of this plan include the following:
• Creation of a Coordinating Body to focus on a vision and next steps.

• Establishment of work groups to address roles and responsibilities; resources; outbreak coordination; data sharing; education and training; research and development; and minimum uniform standards and consistency.

• Solicitation of comments/input from stakeholders on development of an integrated food safety system, including issues developed by the work groups.
2. Food Code: Revise 21 CFR 1250 to incorporate the ’99 Food Code into the Interstate Transportation and Sanitation regulations.

1. Enhance effectiveness of cooperative programs with state and local governments on milk, shellfish, and retail food safety. Specific milestones to accomplish in 1999 include:
   • Milk Safety – Continue the development of a new system to monitor state and federal inspections and testing required for Grade "A" milk.

   • Shellfish – In collaboration with the Field, develop a strategic plan for shellfish.

   • Retail – Audit and verify the regulatory programs conducted in accordance with the Voluntary National Retail Food Regulatory Program Standards, a joint venture with the Conference of Food Protection that is aimed at reducing foodborne illness.

International

1. Develop Affirmative Agenda: Develop, with public input, an affirmative agenda for CFSAN’s international program activities, including participation in Codex activities, equivalence determinations and international compliance issues. Develop a priority-based agenda for the upcoming fiscal year that reconciles the mission and goals with resource availability.
2. Equivalence Criteria: Finalize the criteria the agency intends to use in evaluating the food regulatory systems in foreign countries for the purpose of defining equivalence.
3. Equivalence Determinations: Make an initial equivalence determination for Canada for seafood, and proceed to work towards other equivalence determinations, as provided in the House Appropriations Report.

Human Resources

1. Communication: Encourage communication among all levels of employees within the Center. This will be accomplished through a variety of mechanisms, including all hands communications to employees from the Center Director; continuation of Break Time Seminars; and re-instatement of a bi-monthly newsletter, "Inside CFSAN."

2. Training: Explore new and creative ideas for providing training opportunities to employees. In particular, the Center will strive to increase its internal capacity to train employees through use of computer-based training opportunities, and by enhancing its newly-established Training Resource Room. Established in FY 98, the Training Resource Room is furnished with self-instructional materials that cover a variety of administrative, communication, and management skills.

3. Quality Environment: Pursue initiatives to improve the quality of worklife for all CFSAN employees. Specifically, the Center will implement the Healthy Lifestyles Program, a program piloted in FY 98 to improve employees health, enhance performance and morale, and increase productivity; establish an Employee Worklife Network to compile, triage and address issues raised by employees; follow- up on issues, as appropriate, raised during the transition sessions; and assure that the goals of the equal employment opportunity program are promoted and adhered to.

4. Future Skill Needs: Begin the process of identifying future skill needs by inventorying the skills currently available in the Center and identifying where gaps exist in scientific expertise and other human resource needs.