CFSAN 2000 Program Priorities

1. Food Safety Strategic Plan: Working with the President's Council on Food Safety, finalize the Comprehensive Food Safety Strategic Plan.

1. Egg Safety

1. Publish final rule on labeling and refrigeration of eggs at retail.

2. In conjunction with USDA, and with State and public input, publish proposed nationwide consistent Egg Safety Standards to improve the safety of shell eggs.

2. Imports
1. In conjunction with the U.S. Customs Service, implement the President's directives to prevent the importation of unsafe food:
1. Develop guidance for field personnel to ensure that imported food is held in secure facilities until FDA has reviewed and released the shipments into domestic commerce.
2. Develop guidance for field personnel for determining which health and safety violations are sufficiently serious to require destruction of imported food.
3. Publish a proposed rule on the marking of refused food shipments.
4. Develop a proposed rule for the use of accredited laboratories for testing imported foods.
5. Develop guidance for field personnel on the imposition of civil money penalties, under Customs’ authority, related to the importation of unsafe food.
2. In cooperation with ORA, finalize standardized inspection protocol and double the number of foreign food establishment inspections.

3. In conjunction with the Field, complete 1,000 sample survey of high volume imported produce initiated in FY 99.

4. In accordance with House Report 106-157, submit a report to Congress on activities undertaken to improve coordination and cooperation with the U.S. Customs and in the inspection and regulation of imported foods.

5. In accordance with Senate Report 106-80, ensure timely testing of produce imports.

3. Domestic Inspections
   1. High-Risk Food Inspections: Increase the number of "high risk" inspections, with the goal of annual inspections by 2001.
   2. Evaluation of State Programs: In conjunction with ORA, enhance system for FDA evaluation of state inspection programs.

   3. Food Recalls Report: In accordance with Senate Report 106-80, submit a report to Congress regarding recall activities related to foods.

4. HACCP

   1. Juice HACCP: Publish a final rule regarding HACCP for fruit and vegetable juices to improve their safety.

   2. Seafood HACCP:
      1. In conjunction with the field, conduct third year of annual inspections of high risk domestic seafood processors, with re-inspection of all domestic processors who received an untitled letter or warning letter in 1999, as highest priority. Implement enforcement strategies, as appropriate.
      2. Conduct an evaluation of program performance through the second year, with emphasis on the state of the industry, to assess whether the program is accomplishing its objectives.

   3. Dairy HACCP: In collaboration with the National Conference of Interstate Milk Shippers, initiate a Dairy Grade A HACCP Pilot Program.

5. Produce
   1. In collaboration with states, evaluate industry adoption of the sprout guidance.
   2. In conjunction with the field, initiate sampling assignment to analyze 1,000 domestic produce items for the presence of microbial pathogens.
   3. In collaboration with USDA"s National Agricultural Statistics Service, conduct the Fruit and Vegetable Agricultural Practices Survey and assist in the surveyor training.

6. Food Code
   1. Work with the Conference of Food Protection to resolve controversial issues with the 1999 Food Code.

   2. Achieve adoption of the Food Code by 35 percent of States.

7. Outbreak Response
   1. Develop an agency-wide protocol for conducting traceback investigations that will allow information gathered/learned during the investigation to be used in regulatory actions. Evaluate, using the agency-wide protocol, and revise, as necessary, the Salmonella Enteriditis Traceback Investigation Protocol.

   2. In collaboration with ORA, and state and local governments, continue to provide support for the National Food Safety System Outbreak Coordination Workgroup project to develop guidelines for coordinating multi-state foodborne outbreaks and tracebacks.

1. Explore tools available under the Public Health Service Act to reduce foodborne illness.

2. Develop a hazards and control guide to assist industry in complying with the final juice HACCP regulation.

3. Publish a notice in the Federal Register to initiate a pilot program for HACCP systems in retail establishments, based on voluntary participation from industry.

4. Continue seafood HACCP training program, working through both the district offices and the Seafood HACCP Alliance.

5. Complete and publish the 3^rd edition of the FDA guidelines for seafood HACCP, the "Fish and Fishery Products Hazards and Controls Guide."

6. Develop a guidance document for fresh cut produce.

    

7. Revise the Interstate Travel Sanitation Program to conform to the Food Code provisions relating to travel sanitation.

8. Monitor implementation of control plan for Vibrio parahaemolyticus in shellfish, in conjunction with ORA and the Interstate Shellfish Sanitation Conference.

"A" List

1. Listeria monocytogenes: Review comments on the draft report from the Risk Assessment Consortium and develop final risk assessment.
2. Vibrio parahaemolyticus: Review comments on the draft report from the Risk Assessment Consortium and develop final risk assessment.
3. Methylmercury: Finalize risk assessment of methylmercury based on a subset of data from two key studies.
4. Seafood Parasites Survey: Initiate a medical survey on the incidence of infections from parasites due to the consumption of raw fish, in order to evaluate circumstances in which parasites are a hazard that is reasonably likely to occur.
5. Vibrio vulnificus: Provide initial response to citizen petition 98P-0504 requesting that FDA establish a performance standard for Vibrio vulnificus.
6. Identification of New Assessment Needs: Establish a process for the selection of pathogens/contaminants and/or commodities for conducting risk assessments.
7. Harmonize Standards for E. coli O157:H7: In collaboration with USDA, CDC and EPA, assist in design and implementation of laboratory and information-sharing pilot programs to harmonize federal, state and local laboratories to develop standards for sampling, testing methods and data exchange for E. coli O157:H7 as part of the National Food Safety System (NFSS) project.

"B" List

1. Evaluate and update the 3-year Research Plan to ensure that the research projects the Center is performing provide a strong scientific basis for our regulatory mission.
2. Update "Bad Bug Book" on the Internet. The "Bad Bug Book" provides basic facts regarding foodborne pathogenic microorganisms and natural toxins.
3. Update and post the First Six Chapters of the BAM Manual on the Internet. The Bacteriological Analytical Manual (BAM) is published in collaboration with AOAC International and provides analytical methods for the detection of microorganisms and certain of their metabolic products.
4. In collaboration with CDC, begin development of a Virus Net similar to PulseNet to identify foodborne viral pathogens.
5. Complete cider/apple juice collaborative research aimed at improving the safety of unpasteurized apple juice in response to FDA's proposed requirement for a 5-log pathogen reduction process.
6. Develop an overall risk assessment of methylmercury in seafood incorporating new data expected to be available in the Spring of 2000.

1. Egg Safety: Following publication of the final, develop an education and outreach campaign on labeling and refrigeration of eggs at retail.

2. Fruit and Vegetable Juices: In collaboration with ORA, following publication of the juice HACCP final rule, develop an education and outreach campaign for fruit and vegetable juices.
3. Listeria monocytogenes: Develop a risk communication strategy and risk management actions, as appropriate, following completion of the Listeria risk assessment.

4. Risk Assessment Education: Develop education and outreach campaigns to communicate the appropriate information learned through risk assessments.

5. Good Agricultural Practices: Develop a Producer Education and Outreach Program to provide training programs on the Good Agricultural Practices/Good Manufacturing Practices.

6. Sprout Video: In collaboration with the California Department of Health, the Sprout industry and ORA, complete production and initiate distribution of a video on Good Agricultural Practices/Good Manufacturing Practices (GAP’s/GMP’s) for sprouts.

7. FSI Foreign Outreach and Education: Complete the proceedings from the two outreach meetings held in September 1999 in Santiago, Chile and Mexico City, Mexico, and publicize their availability. Continue foreign outreach and education by planning and co-sponsoring at least one regional outreach meeting in fiscal year 2000.
8. Food Safety Report: In accordance with Senate Report 106-80, in conjunction with the U.S. Department of Agriculture, submit a plan of action to Congress on how to educate the public about the safety of our food supply.

9. Fresh: Conduct stakeholder meetings and focus group research, as appropriate, on the relationship between the use of the term "fresh" on food labels or labeling and the ability of food producers to utilize innovative food processing procedures to ensure safe food.

"B" List

1. Complete development of a Senior Citizen video and teaching program.
2. Complete development of the Secondary School Food Safety Curriculum and continue, in collaboration with the National Science Teachers, to develop the Teacher Enhancement Program.

3. Complete development of the survey instrument for the Food Safety Survey Cycle IV. The survey is used to monitor the impact of food safety initiatives and to identify consumer education needs.

4. Continue to develop and promote Food Safety Campaigns in collaboration with the Partnership for Food Safety Education, through support of National Food Safety Education Month and grass-root efforts conducted at the local levels by FDA Public Affairs specialists.

5. Develop a framework for using warning labels for emerging safety concerns.

1. GRAS: Publish a final rule codifying the GRAS Notification Program.

2. Application Review Goals:

   1. For the petition receipt cohort of FY 99, complete within 360 days of filing, the safety evaluation of 80-90% of those food and color additive petitions that qualify for expedited review.

   2. For the petition receipt cohort of FY 99, complete within 360 days of filing, the safety evaluation of 50-60% of those food and color additive petitions that do not qualify for expedited review.

   3. Reduce by half, the number of pending food and color additive petitions that were more than 4 years overdue at the beginning of the current fiscal year.

   4. Complete initial processing of 80% of biotechnology consultations within established time frame.

   5. Complete processing 80% of GRAS notifications within the time frame established by the final rule.

   6. Complete review of 100% of premarket notifications for food contact substances within 120 days.

3. Food Contact Substances -- Apply new resources made available in FY-2000 congressional appropriations to implement the FDAMA provision for food contact substances:
   1. Announce the availability of guidance documents.
   2. Publish proposed rule on premarket notifications.
   3. Publish direct final rule, along with companion proposed rule, on environmental regulations.

4. Food and Color Additives: Apply new resources made available in FY-2000 congressional appropriations to make enhancements in the direct food and color additive review program. For example, develop and publish guidance to optimize prefiling interactions between the agency and potential applicants of new direct additives and other food ingredients.

5. Simultaneous Review of Food Ingredients in Meat and Poultry: Publish a final rule and develop a memorandum of understanding to implement harmonized joint review with USDA for food and color additive petitions and GRAS ingredient submissions, where meat or poultry product uses are proposed.

1. Develop a strategy for regulating the use of bromates in baked goods.
2. Analyze comments to the irradiation labeling ANPR, and if appropriate, develop a proposal to amend FDA regulations.

3. Publication on the WWW of 5 newly revised Redbook chapters.
4. Develop guidance for industry on the safety assessment of four types of food ingredients (enzymes, proteins, fiber, and lipids).

1. Trans Fatty Acids: Develop a final rule prescribing requirements for the nutrition labeling of trans fatty acids on the nutrition facts panel and in relation to claims.

2. Infant Formula Quality Factors: Publish final rule on infant formula quality factors.

3. Infant Formula GMPs: Develop a final rule on infant formula Good Manufacturing Practices.

4. Citizen Petition: In response to citize 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.

5. Infant formula Notifications: Review premarket notifications for new infant formulas within statutory timeframe.

6. Nutrient Content/Health Claim Submissions: Review and take appropriate timely actions in response to nutrient content claim/health claim petitions and notifications.

7. Enforcement Procedures: Develop effective enforcement procedures to respond to significant or precedent setting discrepancies in food labeling, including trade complaints.

8. Healthy: Develop a proposal on the sodium proviso for the implied nutrient content claim "healthy."

"B" List

1. Develop a strategy based on input from the IOM Food Forum and Keystone, respectively, regarding the most appropriate scientific and regulatory framework for structure/function claims on conventional foods.

2. Develop a coordinated plan between FDA and USDA to correlate existing food standards with current technological innovations.

3. Develop a proposed rule establishing criteria for filing and decision-making on nutrient content/health claim notifications based on an authoritative statement.

4. Develop an interim final rule to clarify and modify the health claim based on an authoritative statement pertaining to the relationship between whole grains and coronary heart disease and certain cancers.

5. Publish a notice of availability on citizen petition 99P-2630 requesting that FDA establish a daily reference value for added sugars and list added sugars in the Nutrition Facts panel.

6. Develop a proposal to update voluntary nutrition labeling values for raw vegetables, fruit, and fish for sale at retail.

7. Develop a proposed rule on reference daily intakes/daily reference values (RDI/DRV's) for chloride and chromium.

8. Develop options for encouraging the voluntary addition of calcium to enriched cereal grains.

9. Initiate a review of food fortification guidelines.

10. Evaluate citizen petitions on caffeine.

"A" List:

1. Safety and Enforcement:

   1. Safety Issues: Identify the highest priority safety issues and initiate appropriate action against unsafe products.

   2. Good Manufacturing Practices: Publish good manufacturing practices proposed rule.

   3. Ephedra: (a) Develop a strategy following review, evaluation, and public availability of new safety information available since publication of 1997 proposed rule; (b) In accordance with House Report 106-157, submit a report to Congress on the Agency's methodology to be used in Ephedra rulemaking.

   4. Public Availability of Adverse Event Reports: Significantly reduce Freedom of Information Act backlog on the adverse event report monitoring system.

   5. Notifications: Continue to review premarket (75-day) notifications for new dietary ingredients within the statutory timeframe.

   6. Routine Compliance: Develop streamlined case development process with ORA and CDER.

2. Labeling and Boundaries

   1. Structure/Function Claims: Publish a final rule.

   2. Pearson v. Shalala: Conduct public meeting, review scientific data for four subject claims, and develop rulemaking.

   3. Claims: Seek public input, and develop a policy on when a disease-related statement is an appropriate health claim for a dietary supplement, and when a disease claim is necessarily a drug claim.

   4. Health Claim Petitions: Continue to review health claim petitions within the statutory timeframe.

3. Outreach

   1. Dietary Supplement Strategic Plan: Disseminate the dietary supplement strategic plan to the public.

   2. Advisory Committee: Establish a standing group (e.g., subcommittee of the Food Advisory Committee) to provide a routine public forum to obtain and integrate stakeholder input related to various dietary supplement issues. The group will be comprised of members having expertise relevant to the review of dietary supplement issues.

"B" List

1. Safety and Enforcement

   1. Training: Provide in-house training to field and headquarters staff to ensure consistency with current FDA regulatory procedures and practices in the field.

   2. Labeling and Consumer Fraud: Take appropriate action on inaccurate and misleading labeling and consumer fraud, including trade complaints.

   3. FTC Liaison: Enhance collaborations with FTC on labeling issues.

   4. Routine Compliance: Incorporate inspections for compliance with new labeling regulations into inspection program.

2. Labeling and Boundaries:

   1. Small Business Regulatory Enforcement and Flexibility Act (SBREFA) Guidance: Following publication of final structure/function rule, develop SBREFA guidance, in conjunction with CDER.

   2. Claims Review: Continue to review 30-day postmarket notifications for supplement claims in a timely manner.

   3. "Per Day" Nutrition Labeling: Develop final rule on "Per Day" labeling for dietary supplements.

   4. Claims Database: Develop database for 30-day label claim notifications and courtesy letters.

3. Science Base

   1. Research Agenda: Initiate development of a research agenda, including consumer research on the understanding of label information and claims.

   2. Leveraging Resources: Identify ways to leverage resources to address dietary supplement issues and research needs.

   3. Pharmacognosy: Develop/recruit pharmacognosy expertise in headquarters.

4. Outreach

   1. Information Kits: Disseminate information kits for FDA field staff and institute regular updates with field staff.

   2. Information Dissemination: Communicate dietary supplement enforcement policies and procedures to the general public, FDA field offices, health care professionals, and industry.

"A" List

1. Implementation of Food Quality Protection Act (FQPA): Develop a "pipeline" compliance policy guide (CPG) for residues of methyl parathion and azinphos methyl as foods for which tolerances were revoked or reduced.

2. Patulin: Issue a compliance policy guide (CPG) establishing a level for patulin found in apple juice and apple juice-containing products.

3. Pesticide Monitoring Improvements Act (PMIA): Publish on the Internet FDA's pesticide monitoring data and summary information as required by PMIA.

4. Fumonisin: (a) In collaboration with JIFSAN and WHO, convene an international workshop to consider all available risk assessment data on fumonisin; (b) issue fumonisin guidance.

5. Bottled Water Feasibility Study: As provided in the Senate Report 106-80, publish the draft and final study of the feasibility of appropriate methods of informing consumers of the contents of bottled water as mandated by the Safe Drinking Water Act Amendment of 1996.

"B" List

1. Update the pesticide CPG to bring it in line with FQPA and changes in pesticide programs and policy over the past few years.

2. Develop a proposal to revise the current total coliform standard to be more comparable to EPA's total coliform standard for public drinking water, in conjunction with withdrawal of 1993 coliform standard proposal.

3. Determine whether to develop a proposal to adopt EPA's regulation for disinfection byproducts in public drinking water as a quality standard for bottled water.

4. Develop a compliance policy guide for sampling and analyzing fresh and frozen raw shrimp for decomposition.

5. Validate the new EPA enhanced sensitivity method and analyze 500 food samples for organophosphate pesticides to assist the EPA in doing risk assessments.

"A" List

1. Cosmetic Ingredient Safety

   1. Alpha Hydroxy Acids

      1. Develop proposal for labeling of AHA containing products.
      2. Support NTP photocarcinogenicity testing.

   2. Beta Hydroxy Acids: Support NTP safety study of Beta Hydroxy Acids.
   3. Diethanolamine (DEA): Complete evaluation of DEA risk assessment and develop risk management approaches, as appropriate.

2. Cosmetics Enforcement and Surveillance:

   1. Develop strategy for issuance of 740.10 warnings for products formulated with ingredients that lack adequate safety.

   2. Develop strategy for issuance of untitled letters for cosmetic products with labeling violations.

3. The Cosmetics Voluntary Registration Program (CVRP)

   1. Streamline CVRP: Design a WEB-based, interactive registration system for streamlining the CVRP.
   2. Participation Incentives: Determine feasibility of establishing participation ncentives.

"B" List

1. Cosmetic Labeling and Ingredient Nomenclature:

   1. Complete review of ingredient dictionary and develop proposed regulation for cosmetic ingredient nomenclature.
   2. Develop alternative strategy for ingredient nomenclature and assess feasibility of establishing a US Cosmetics Ingredient Inventory.

2. Cosmetic Enforcement and Surveillance: Develop streamlined case development process with ORA and CDER.
3. Consumer and Industry Assistance:

   1. Update and enhance cosmetics WEB page.
   2. Complete preparation of draft of revised Cosmetics Handbook for consumers and industry.

4. International Harmonization: Continue to support EU-US bilateral program and the Cosmetics Harmonization and International Cooperation (CHIC) initiative.

5. Color Additive Lakes: Make progress on the listing final rule.

1. Research Planning and Management
   1. Present External Peer Review Report to FDA Science Board; implement recommendations as appropriate.
   2. Finalize the report of the Research Management Task Group and initiate the development of an implementation plan.
   3. Finalize report of the MOD 1 Task Group and develop an implementation plan.

2. Professional Development
1. Acquire risk communication training for senior level managers and mid-level managers.

2. Review current Peer Review Process for Research and Regulatory Scientists.
3. Leveraging Scientific Expertise
1. Restructure the CFSAN Food Advisory Committee to enhance its ability to provide expert scientific advice in specialized areas.

"B" List

1. Implement recommendations of the Scientific Manuscript Clearance Task Group.

2. Enhance Visiting Scientist Program.

1. Implement the CFSAN Affirmative Agenda for International Activities:
   1. Publish Equivalence Criteria: Publish a Federal Register notice conveying FDA's criteria for evaluating foreign food safety systems to determine their equivalence to that of the U.S.
   2. Codex Committees and Working Groups: Participate in 18 Codex committees and related meetings to promote development of harmonized food safety and labeling standards.
   3. World Health Organization - Cooperation on Food Safety: Collaborate with the World Health Organization to strengthen their role in food safety.

"B" List

1. Equivalence Determinations:
   1. Make significant progress toward, and complete where possible, equivalence determinations for seafood for Canada, New Zealand, Australia, Japan, Chile, and possibly other countries;
   2. Conduct equivalence evaluation of the European Union dairy safety and production system by performing equivalence audits in three or more EU member states.

2. NAFTA Technical Working Groups (TWGs): Coordinate and conduct meetings of NAFTA TWGs on Food Additives and Contaminants; Dairy, Fruit, Vegetables and Processed Foods; and Food Packaging and Labeling.
3. Standard-Setting: Establish FDA Consumer article series on international standard-setting activities.

1. Biotechnology: Develop and implement strategies based on public meetings held in fall 1999.
2. Food Allergens:
1. Raise consumer and industry awareness to the presence of allergens in foods. Conduct meetings on labeling approaches to identify the presence of allergens.
2. Develop a proposed rule to require declaration of carmine/cochineal extract on the ingredient statement of food products containing it.

3. Adverse Event Reporting (AER): Develop action plan for integrating all AER systems within CFSAN.

1. CFSAN-Field Relations: Initiate development of an action plan to strengthen working relations between CFSAN and ORA in the areas of: (1) budget and work plan; (2) outbreaks and tracebacks; (3) inspections and field programs; (4) international programs; (5) enforcement; and (6) laboratories.

2. Regulations Process: Evaluate CFSAN regulations development process for quality and efficiency and make recommendations for improvement.

3. Communications: Develop a plan to improve responses to the Field Offices, the states and other federal agencies through better utilization of the internet and e-mail, improved correspondence control and improved telephone responsiveness.

4. Bioterrorism: In conjunction with ORA, and after consultation with other federal agencies, develop a CFSAN bioterrorism plan to address intentional chemical and biological contamination of foods and water associated with food production.

1. In response to a citizen's petition, complete final regulations to establish common or usual names for several species of crab, to assist consumers in better distinguishing among various crabmeats in the marketplace.

"B" List

1. Develop proposed regulations to establish a standard of fill for cans of tuna based on the drained weight of the contents, to allow for upgrades in methodology for determining weight and to achieve consistency with international standards.
2. Develop proposed regulations to establish a standard of identity for scallops, to help protect consumers from economic fraud due to the addition of excess water during processing.
3. Publish a final rule to establish a food standard for white chocolate.

1. "New Day": Provide the necessary training and support for "New Day" implementation within the Center.

2. Implement the National Treasury Employees Union (NTEU) Contract: Work with NTEU Leadership to ensure smooth implementation of contract. Establish and make operational a partnership council and necessary implementation committees.

3. Recruitment and Hiring: Conduct a proactive recruitment program to attract the highest quality candidates and hire them for authorized vacancies.

4. New Employee Training: Mount an intensive program of orientation, training, mentoring, and support for new employees. Create environment where new employees truly feel like they are FDA's most valuable resource.

5. Integrated Financial Management System (FMS): Implement a new networked financial management system, interfacing with the Agency financial system, to better track and manage financial and personnel resources.

6. College Park: Maintain a comprehensive program of action and information sharing to ensure a smooth occupancy of the College Park facility in 2001:

   1. Start a scheduled program of information bulletins to employees on the status of the project and the programs in place to plan the move.

   2. Identify options and negotiate agreements to ensure adequate lab and office space for all CFSAN employees.

   3. Continue the task groups in place that are responsible for planning the detailed projects necessary to occupy the College Park facility.

"B" List

1. Quality of Worklife: Continue to provide mechanisms for improved communication and quality of worklife.

2. Information Technology (IT): Provide an adequate infrastructure for new and existing IT systems and networks. Provide support to the Center through an upgraded and fully staffed Help Desk.