U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
January 29, 2002


CFSAN 2002 Program Priorities

Letter from Center Director
Table of Contents

Dear Colleague, FDA Foods Community

I am pleased to share with you the FY 2002 Program Priorities for FDA's Center for Food Safety and Applied Nutrition (CFSAN). This document represents the Center's work product expectations for the current fiscal year 2002 (October 1, 2001 through September 30, 2002), and it is based on input we received from you (our stakeholders) as well as input generated internally, with focus on one central question: "Where do we do the most good for consumers?" On behalf of CFSAN, I thank you for your review and comments to the process.

We recognize that all our stakeholders are concerned about recent events affecting food safety and security. This work plan specifically addresses increasing the security of our country's food supply as our #1 goal. Because the strategies in this important area are still developing, we will provide more detail in our mid-year report. We are also aware that placing a high priority on this area may affect our ability to accomplish other goals in this workplan. We may, therefore, need to make adjustments in our goals and priorities at that time.

The format of the FY 2002 workplan is similar to the 2001 workplan, with several specific changes. The entire document is organized in tabular format. Parts I, II and III of the workplan have been renamed:

I. Assuring Food Safety and Security
II.Assuring Food and Cosmetic Safety: Specific Program Areas
III. Assuring Food Safety: Crosscutting Areas

The Food Safety and Security section has been broadened by including additional food safety strategies under this section: Food Allergens; Transmissible Spongiform Encephalopathies (TSEs); and Chemical Contaminants, Pesticides and Other Hazards. Within the Specific Program Areas, we have organized activities under five common headings.

In addition to adding a new emphasis on enhancing the security of our food supply, this plan continues to place the highest priority on food safety, food additives, dietary supplements, and food biotechnology. The plan also increases our emphasis on food allergens, and addresses completing the move of CFSAN offices and laboratories to the new facility in College Park, MD.

In total, there are 92 "A" list goals in this year's workplan, with more expected as specific goals under food security are identified. As with last year's format, the workplan contains three priority levels of activities - - the "A" list, "B*" list and "B" list. Our plan will be to complete fully at least 90% of the "A" List items by the end of the current fiscal year, September 30, 2002. I frequently describe these as the "boulders" we will strive to move up and over the "mountaintop." Activities on the "B" list are those we plan to make progress on, but which we may not complete before the end of the fiscal year. "B*" list activities are our highest-level B-list items. Many of these are two-year projects that we are positioning to be candidates for the "A" list next year. Each goal in this year's plan is assigned a priority level in the right-hand column, and A-list goals are printed in bold print for easy recognition.

This workplan does not address the myriad of unanticipated issues that often require a substantial investment of CFSAN resources (e.g., responses to outbreaks of foodborne illness), as well as our many ongoing regulatory, communication and research activities.

In closing, I thank you, our many stakeholders, for your continuing support. I look forward to working with you as we complete these many important activities for the benefit of American consumers.

Sincerely,

 

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

 


Table of Contents

 

  1. ASSURING FOOD SAFETY and SECURITY


  2. ASSURING FOOD and COSMETIC SAFETY: Specific Program Areas


  3. ASSURING FOOD SAFETY: Crosscutting Areas


Part I
Assuring Food Safety and Security

Contents - Priority Areas

Food Security: General
Domestic Inspections
Imports and Foreign Inspections
Seafood Safety
Fruits and Vegetables
Egg Safety
Listeria
Cooperative Programs
Chemical Contaminants, Pesticides and Other Hazards
Transmissable Spongiform Encephalopathies (TSEs)
Food Allergens
Education

Priority Areas

Food Security: General
Strategy Sub Strategy Goal Description Priority Level
1.1 1.1.1 Food Security Action Plan: Develop and implement strategies toward threat assessment and emergency preparedness for addressing food counter-terrorism and food security issues. A
1.1 1.1.2 Hire, Train and deploy additional resources as provided by Congress, with particular attention to strengthening surveillance of imported foods. A
1.1 1.1.3 Develop new legislation (and, if enacted, implement) designed to strengthen FDA's preparedness. A
1.1 1.1.4 Develop guidance for industry on how food establishments can increase their preparedness and enhance the security of their products. A
1.1 1.1.5 Enhance coordination with other Federal, State and local organization in addressing food counter-terrorism and food security issues. A

 

Domestic Inspections
Strategy Sub Strategy Goal Description Priority Level
1.2 1.2.1 Implement the compliance program to inspect 95% domestic firms that produce "high-risk" foods. Implement enforcement strategies. A
1.2 1.2.2 Continue to implement three-year strategy to enhance FDA audit and evaluation of State inspection programs. A

 

Imports and Foreign Inspections
Strategy Sub Strategy Goal Description Priority Level
1.3 1.3.1 FDA/U.S. Customs Joint Action Plan: Publish a final rule on the marking of refused food shipments. A
1.3 1.3.2 FDA/U.S. Customs Joint Action Plan: Publish guidance for field personnel for determining which health and safety violations are sufficiently serious to require destruction of imported food. A
1.3 1.3.3 Conduct 160 - 180 foreign inspections, with "high-risk" foods as a top priority. A
1.3 1.3.4 Finalize the development of a Compliance Policy Guidance, which defines the criteria for refusing entry of food products from firms, which refuse to allow FDA to inspect their facilities. B*
1.3 1.3.5 FDA/U.S. Customs Joint Action Plan: Develop a proposed rule to set standards for the use of private laboratories and for testing imported foods. B*
1.3 1.3.6 Amend 21 CFR 1.90 to allow discretion to release import samples prior to completion of analysis. Develop and implement standard operating procedures implementing change in 21 CFR 1.90. B

 

Seafood Safety
Strategy Sub Strategy Goal Description Priority Level
1.4 1.4.1 Complete an evaluation of program performance through the fourth year, with an emphasis on the state of the industry, to assess whether the program is accomplishing its objectives and to identify where and how the program needs to be re-directed. A
1.4 1.4.2 Continue to work with the ISSC to implement a control strategy for Vibrio vulnificus in raw oysters. A
1.4 1.4.3 Respond to citizen petition 98P-0504 requesting that FDA establish a performance standard for Vibrio vulnificus. A
1.4 1.4.4 Submit a report to Congress on assuring the safety and quality of shellfish and development of shellfish regulations. A
1.4 1.4.5 Submit a report to Congress regarding implementation of recommendations by GAO, and the timetable for bringing all FDA-regulated seafood processors in compliance with HACCP. A
1.4 1.4.6 Develop an overall public health strategy for methylmercury in commercial seafood. B*
1.4 1.4.7 Continue project to improve existing guidance on proper on-board handling to the fishing industry that harvest scombroid species, and to educate the industry on how to comply with that guidance. B
1.4 1.4.8 Continue project to develop good aquaculture practices to ensure that aquaculture waters are not a source of pathogens or other contaminants. B
1.4 1.4.9 Continue to work with the ISSC to develop a final control strategy for Vibrio parahaemolyticus. B
1.4 1.4.10 Make progress on study of optimum seafood-based inspection frequency. B
1.4 1.4.11 Continue to compare equivalence of North American shellfish programs to European shellfish program. B

 

Fruits and Vegetables
Strategy Sub Strategy Goal Description Priority Level
1.5 1.5.1 Issue a Juice HACCP Field Assignment in collaboration with the Office of Regulatory Affairs. A
1.5 1.5.2 Issue draft of the 1st edition of FDA Hazards and Controls Guide for Juice. A
1.5 1.5.3 In conjunction with ORA, develop and conduct training of field investigators in juice HACCP inspections. A
1.5 1.5.4 Issue Juice HACCP 5-log Guidance. A
1.5 1.5.5 Issue guidance on the transport of concentrated juices. A
1.5 1.5.6 Develop additional Juice HACCP Questions and Answers. B*
1.5 1.5.7 Develop a guidance document for fresh cut produce. B*
1.5 1.5.8 Assist the Juice Alliance in developing a juice HACCP training program and in conducting industry training. B
1.5 1.5.9 Issue Small Entities Guide for the Juice HAACP Regulation. B
1.5 1.5.10 Produce and distribute video on safe juice processing with the California Department of Health Services (CDHS). B
1.5 1.5.11 Evaluate information from completed domestic and imported produce sample assignments and determine next steps. B
1.5 1.5.12 In conjunction with ORA, issue a sampling assignment to analyze 500 domestic/ imported produce items for the presence of microbial pathogens. B
1.5 1.5.13 Finalize imported produce safety action plan and begin implementation. B
1.5 1.5.14 Assist Industry in development and delivery of education training programs promoting produce safety. B
1.5 1.5.15 Issue Ackee Assignment. B

 

Egg Safety
Strategy Sub Strategy Goal Description Priority Level
1.6 1.6.1 Conduct an education campaign for the egg labeling and refrigeration rule. A
1.6 1.6.2 Publish proposed egg safety rule for farm and retail. A
1.6 1.6.3 Work with States to implement egg label and refrigeration rule. A
1.6 1.6.4 Develop proposal to allow in-lid labeling for safe-handling instructions for shell eggs. B*

 

Listeria
Strategy Sub Strategy Goal Description Priority Level
1.7 1.7.1 Issue a field assignment for fresh soft, soft, and semi-soft cheeses to gather additional data for the Listeria risk assessment. A
1.7 1.7.2 In response to public comments, revise the January 2001 risk assessment on Listeria monocytogenes contamination in ready-to-eat foods. B*
1.7 1.7.3 Develop a draft guidance document advising processors on steps to reduce Listeria monocytogenes contamination in ready-to-eat foods. B*

 

Cooperative Programs
Strategy Sub Strategy Goal Description Priority Level
1.8 1.8.1 Achieve adoption of the Food Code in 28 states in the U.S. A
1.8 1.8.2 Work with the States to address compliance of imported "Grade A" milk and milk products within the PMO and imported shellfish within the NSSP based cooperative programs. A
1.8 1.8.3 Publish 2001 edition of the Food Code. A
1.8 1.8.4 Develop a proposed rule consistent with the Food Code for Interstate Travel Program conveyances and support facilities and establish infrastructure to implement the rule. B

 

Chemical Contaminants, Pesticides and other Hazards
Strategy Sub Strategy Goal Description Priority Level
1.9 1.9.1 Expand the dioxin monitoring and dietary assessment project. A
1.9 1.9.2 Collect and analyze 8000 food samples to maintain current level of monitoring for pesticides and environmental contaminants. A
1.9 1.9.3 Develop analytical methods for total mercury and Methyl mercury. B*
1.9 1.9.4 Develop revised Compliance Policy Guidance on radionuclides in foods. B*
1.9 1.9.5 Revise radionuclides quality standard for bottled water. B*
1.9 1.9.6 Develop a proposal to revise the bottled water quality standards for arsenic. B*
1.9 1.9.7 In collaboration with the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), conduct an international workshop on mycotoxins for developing countries. B
1.9 1.9.8 Develop guidance on the scientific parameters to be considered when validating processes designed to deliver a specific pathogen kill rate. B
1.9 1.9.9 Develop Compliance Policy Guidance to implement the reengineered filth strategy. B
1.9 1.9.10 Develop for the Internet the FDA Pesticide Monitoring data and summary information as required by the Pesticide Monitoring Improvement Act. B

 

Transmissible Spongiform Encephalopathies (TSEs)
Strategy Sub Strategy Goal Description Priority Level
1.10 1.10.1 Develop a CFSAN portion of Agency regulation banning use of bovine materials from BSE or BSE high-risk countries in CFSAN-regulated products. B*
1.10 1.10.2 In cooperation with USDA, develop a regulation prohibiting use of any part of an elk or deer exposed to chronic wasting disease (CWD) from CFSAN-regulated products. B*
1.10 1.10.3 In cooperation with USDA, develop a regulatory approach to minimize human exposure to BSE from the use of bovine brain and spinal cord from animals 24 months or older in CFSAN-regulated products. B*

 

Food Allergens
Strategy Sub Strategy Goal Description Priority Level
1.11 1.11.1 Continue consumer and industry outreach and awareness to the presence of allergens in food. A
1.11 1.11.2 Develop and implement an allergen enforcement strategy for cross-contamination. A
1.11 1.11.3 Conduct training of field investigators on food allergens. A
1.11 1.11.4 Submit a report to Congress on FDA's plans to promulgate regulations to prevent cross-contamination of foods by undeclared allergens. A
1.11 1.11.5 Submit a report to Congress on the incidence of latex allergies related to food handling, FDA's monitoring of the situation, and Agency plans to eliminate exposure to latex from food handling if data warrant such a decision. A
1.11 1.11.6 Develop a proposed rule to require the declaration of carmine/cochineal extract, a color additive, on the ingredient statement of food, drug, and cosmetic products containing it. B*
1.11 1.11.7 Develop a strategy to improve the labeling of the most common allergens to include responding to the "Nine States Attorneys General" petition. B*
1.11 1.11.8 Evaluate commercially available methods for peanut allergens for application to FDA monitoring programs. B*
1.11 1.11.9 Evaluate the science and develop specific options for addressing allergenicity issues related to the use of natural rubber latex gloves by food handlers. B

 

Education
Strategy Sub Strategy Goal Description Priority Level
1.12 1.12.1 In conjunction with the State of California, develop an education and outreach program on Vibrio for Hispanic men. A
1.12 1.12.2 International Outreach: Conduct one Regional Food Safety Workshop to provide information on key U.S. food safety initiatives. A
1.12 1.12.3 Conduct education and outreach on methylmercury in seafood to heavy fish-eating audiences in selected states. B
1.12 1.12.4 Develop Food Safety Program for Pregnant Women. B
1.12 1.12.5 Develop and distribute Seafood Safety Education Materials. B

 

Part II
Assuring Food and Cosmetic Safety:
Specific Program Areas

Contents - Priority Areas

Premarket Review of Food and Color Additives and Food Ingredients
Nutrition, Health Claims and Labeling
Dietary Supplements
Cosmetics

Priority Areas

Food and Color Additives: Premarket Review
Strategy Sub Strategy Goal Description Priority Level
2.1.1 Review of Industry Submissions/Statutory Requirements
2.1 2.1.1 a. For the petition receipt cohort of FY 2001, complete within 360 days of filing, the safety evaluation of at least two of the three food and color additive petitions that qualify for expedited review. A
2.1 2.1.1 b. For the petition receipt cohort of FY 2001, complete within 360 days of filing, the safety evaluation of 60-70% of those food and color additive petitions that do not qualify for expedited review. A
2.1 2.1.1 c. Complete the safety evaluation of 60% of the number of food and color additive petitions that were under review for more than 360 days at the beginning of FY 2001. A
2.1 2.1.1 d. Complete CFSAN evaluation of biotechnology final consultations received in FY 2001 within 180 days. A
2.1 2.1.1 e. Complete processing of 80% of GRAS notifications (GRNs) in the receipt cohort of FY 2001 within 180 days. A
2.1 2.1.1 f. Complete review of premarket notifications for food contact substances in the receipt cohort of FY 2001 within the statutory time limit (120 days). A
2.1.2 Congressional Reports/Directives
2.1 2.1.2 a. Submit an annual report to the appropriations committee of the House of Representatives and the Senate that provides an estimate of the costs of carrying out the premarket notification program. A
2.1.3 Protecting and Promoting Public Health with Agency Initiated Actions
2.1 2.1.3 a. Publish final Food Contact Substance (FCS) Regulation. A
2.1 2.1.3 b. Publish final FCS guidance documents for administrative, toxicology and chemistry. A
2.1 2.1.3 c. Develop a strategy for ensuring that dietary supplement ingredients, when added to conventional foods, are lawful. A
2.1 2.1.3 d. Develop draft guidance on the preparation of Environmental Assessments or claims of categorical exclusion. B*
2.1 2.1.3 e. Develop for the World Wide Web three newly revised Redbook chapters. B
2.1 2.1.3 f. Develop guidance for prefiling consultations for new petitions and notifications; communicate with prospective submitters to encourage prefiling consultations for new petitions and notifications. B
2.1 2.1.3 g. Bromates: Complete work on developing a strategy for regulating the use of bromates in baked goods and respond to the pending citizen petition on bromates. B
2.1 2.1.3 h. Develop documents to adopt the specifications in the most recent edition of the Food Chemicals Codex into regulations as appropriate. B
2.1.4 Improve Efficiency/Responsiveness
2.1 2.1.4 a. Implement the electronic submission of food and color additive petitions and provide general guidance for all types of submissions in electronic format. Provide appropriate training to submitters. A
2.1 2.1.4 b. Develop a final rule for the GRAS notice program. B*
2.1.5 Enforcement/Compliance
2.1 2.1.5 a. Develop enforcement strategy and field assignments to ensure appropriate maximum levels of chloropropanols in specific foods. B

 

Nutrition, Health Claims and Labeling
Strategy Sub Strategy Goal Description Priority Level
2.2.1 Review of Industry Submissions/Statutory Requirements
2.2 2.2.1 a. Continue to review premarket notifications for new infant formulas within statutory timeframe. A
2.2 2.2.1 b. Continue to review nutrient content/ health claim notifications and petitions within statutory timeframe. A
2.2 2.2.1 c. Publish a final rule for stanol/sterol esters health claim. B*
2.2.2 Congressional Reports/Directives
2.2 2.2.2 a. Report to Congress on the outcome of recent focus groups regarding the labeling of irradiated food products and how the results will be integrated into future rulemaking decisions. A
2.2.3 Protecting and Promoting Public Health with Agency Initiated Actions
2.2 2.2.3 a. Publish proposal on the sodium provisions for the implied nutrient content claim "healthy" together with a notice of extension of the effective date. A
2.2 2.2.3 b. Develop a final rule for trans fatty acid labeling. B*
2.2 2.2.3 c. Develop a final rule for infant formula GMPs and quality factors. B*
2.2.4 Improve Efficiency/Responsiveness
2.2 2.2.4 a. Publish a proposed rule to update nutrient values for voluntary nutrition labeling program. A
2.2 2.2.4 b. Clarify nature of appropriate post-market surveillance for new/novel ingredients added to infant formula, and collaborate with National Institute of Child Health and Human Development (NICHD) to develop a plan for surveillance of infant formula adverse event and health outcomes. B*
2.2 2.2.4 c. Develop proposed rule for nutrient content claims that are the subject of health claims. B
2.2 2.2.4 d. Develop a final rule providing for more flexibility in the use of health/nutrient content claims in response to citizen's petition. B
2.2.5 Enforcement/Compliance
2.2 2.2.5 a. Continue to conduct enforcement activities to clarify boundaries between conventional foods and other product categories. A

 

Dietary Supplements
Strategy Sub Strategy Goal Description Priority Level
2.3.1 Review of Industry Submissions/Statutory Requirements
2.3 2.3.1 a. Continue to review premarket (75-day) notifications for new dietary ingredients within statutory timeframe. A
2.3 2.3.1 b. Continue to review 30-day postmarket notifications for supplement claims in a timely manner. B
2.3.2 Congressional Reports/Directives
2.3 2.3.2 a. Submit report to Congress on FY2000 spending to assess the safety of Dietary Supplements. A
2.3 2.3.2 b. Submit report to Congress on the dollar cost to implement the Dietary Supplement Strategic Plan. A
2.3.3 Protecting and Promoting Public Health with Agency Initiated Actions
2.3 2.3.3 a. Publish proposed rule for dietary supplement GMPs and conduct outreach. A
2.3 2.3.3 b. Continue to develop mechanisms to enhance timely clinical assessment of dietary supplement adverse event investigations. A
2.3 2.3.3 c. Develop a strategy for dietary supplements that contain ephedrine alkaloids. B*
2.3.4 Improve Efficiency/Responsiveness
2.3 2.3.4 a. Issue "Regulatory Guidebook" for industry. A
2.3 2.3.4 b. Publish update for common or usual botanical names used in dietary supplement labeling as provided for in current rule. A
2.3 2.3.4 c. Develop "Dietary Supplement Labeling Guide" for Industry. B
2.3 2.3.4 d. Work to develop guidance on appropriate safety information to include in 75-day notifications. B
2.3 2.3.4 e. Conduct training for field staff and State officials on dietary supplement regulatory provisions and safety issues. B
2.3 2.3.4 f. Develop final rule on "per day" labeling for dietary supplements. B
2.3.5 Enforcement/Compliance
2.3 2.3.5 a. Continue to identify dietary supplement ingredients/products that raise safety problems, and take appropriate enforcement actions. A
2.3 2.3.5 b. Support activities to include dietary supplements within food pesticide/contaminant compliance programs. A

 

Cosmetics
Strategy Sub Strategy Goal Description Priority Level
2.4.1 Protecting and Promoting Public Health with Agency Initiated Actions
2.4 2.4.1 a. Certified Color Additives: Analyze all batches of color additives and determine certification status (certify or refuse to certify) within an average of 5 working days. A
2.4 2.4.1 b. Alpha Hydroxy Acids (AHA): Publish draft guidance on labeling of AHA containing products. A
2.4 2.4.1 c. Diethanolamine (DEA): Develop risk assessment approaches; initiate implementation of risk management decisions. B*
2.4 2.4.1 d. Color Additive Lakes: Develop final rule permanently listing color additive lakes through FDA. B*
2.4 2.4.1 e. Cosmetic Product Safety: Support NTP/NCTR photocarcinogenicity testing of glycolic acid and salicylic acid. B
2.4 2.4.1 f. International Harmonization: Continue support of EU-US bilateral program and the Cosmetics Harmonization and International Cooperation (CHIC) initiative B. B
2.4.2 Improve Efficiency/Responsiveness
2.4 2.4.2 a. Voluntary Cosmetic Registration Program (VCRP): Implement the WEB-based, interactive registration system, as follows: Beta test, and selectively bring on line, the WEB-based, interactive registration system. B*
2.4 2.4.2 b.Certified Color Additives: Develop standard operating procedures for planning, conducting and implementing results from inspections of color additive. B
2.4 2.4.2 c. Cosmetic Labeling: Develop a strategy for amending §701.3(c)(2) to update sources for naming cosmetic ingredients. B
2.4 2.4.2 d. Develop Federal Register notice for issuance of Cosmetic Handbook for Industry. Prepare the Handbook for the Cosmetic web site and make copies available to requesters. B
2.4 2.4.2 e. Continue updating and enhancing cosmetics and colors WEB pages. B
2.4.3 Enforcement/Compliance
2.4 2.4.3 a. Complete Memorandum of Understanding (MOU) with FDA's Center for Drug Evaluation and Research that allows the Office of Cosmetics and Colors to manage enforcement actions for certain cosmetic product whose label or labeling contains structure/function or disease claims. Initiate implementation of MOU. A
2.4 2.4.3 b. Publish draft guidance for issuance of §740.10 warnings for products formulated with ingredients that lack adequate safety substantiation. B*

 

Part III
Assuring Food Safety:
Crosscutting Areas

Contents - Priority Areas

College Park
Science Base
International
Food Biotechnology
Internal Processes
Focused, Economic-based Regulations
EEO/Diversity Initiatives
Management Initiatives

Priority Areas

College Park
Strategy Sub Strategy Goal Description Priority Level
3.1 3.1.1 Execute and carry to completion the orderly move of all CFSAN personnel, associated laboratories and offices from the South West Metropolitan DC area to the new headquarters site in College Park Maryland. A
3.1 3.1.2 Institute specialized renovation plans to prepare the space for individual needs of the major offices units within CFSAN. A
3.1 3.1.3 Continue plans to acquire additional space in an adjunct building at College Park. A
3.1 3.1.4 Implement detailed plans to decommission Federal Office Building 8 in preparation for returning it to the General Services Administration. A
3.1 3.1.5 Renovate the Beltsville Research Facility and the 3rd floor of the MOD I facility in order to accommodate the Office of Science, Office of Seafood and Office of Cosmetics and Color personnel scheduled to move to those locations. A
3.1 3.1.6 Transition Activities: Continue and expand activities aimed at assisting employees in making a successful transition to the College Park facility. A

 

Science Base
Strategy Sub Strategy Goal Description Priority Level
3.2 3.2.1 Develop and implement an enhanced program for laboratory emergency preparedness. A
3.2 3.2.2 Amend the JIFSAN Memorandum of Understanding, and renew the Five Year Cooperative Agreement based on program evaluation and projected Center needs. A
3.2 3.2.3 Implement the Cooperative Agreement with the University of Mississippi on dietary supplement research. A
3.2 3.2.4 Implement new Advisory Committee structure and operations, including the four subcommittees (biotechnology; dietary supplements,; food additives and ingredients,; and contaminants). A
3.2 3.2.5 In conjunction with the National Center for Toxicological Research, initiate a targeted research and toxicological testing program on one or two dietary supplements for which there are significant safety questions. B*
3.2 3.2.6 Develop five-year strategic plan for research on food safety, cosmetic safety, and dietary supplement safety. B*
3.2 3.2.7 Revise the Center's systems for laboratory quality assurance, including the GLP program, as part of the agency's initiative on laboratory accreditation. B
3.2 3.2.8 Formalize and strengthen the framework and process for collaboration between CFSAN and NCTR for greater coordination in identification, prioritization and planning of research in support of the food, dietary supplement, and cosmetic safety programs. B

 

International
Strategy Sub Strategy Goal Description Priority Level
3.3 3.3.1 Codex Committees and Working Group: Participate in and raise visibility in the Codex committees, ad hoc task forces, and related drafting and working groups and scientific advisory committees meeting in FY 2002 that are of relevance to the FDA. The most visible efforts are the following committees/task force where CFSAN provides the Delegate:  

Cross-cutting General Subject Committees:
Food Hygiene (Delegate) A
Food Additives and Contaminants (Delegate) A
Food Import and Export Inspection and Certification Systems (Delegate) A
Nutrition and Foods for Special Dietary Uses (Delegate) A
Food Labeling (Delegate) A

Task Force:
Foods Derived from Biotechnology (Delegate) A
3.3 3.3.2 WHO/FAO Global Forum for Food Safety Regulators: Building on the May 2000 WHO Resolution on Food Safety, and as recommended by the G7 nations, support and participate in the planning of the Global Forum for Food Safety Regulators. A
3.3 3.3.3 Export Certificates: Compile data on export certificates with input from state, federal government and industry to assure FDA has all available information for appropriate decision making. The compilation of this information will facilitate progress in defining the needs of exporters for food export certificates and approaches to issuing them, including current and future demands on the agency for issuing such certificates. B
3.3 3.3.4 Export Certificates: Participate in national and international policy discussions on export certificates. Discussions and reviews with states, industry, trade agencies, consumer groups and other stakeholders will continue. The overall objective is to assure consistency of international guidance regarding export certificates with U.S. practices. B
3.3 3.3.5 Equivalence Criteria: Develop a Federal Register notice conveying FDA's criteria for evaluating foreign food safety systems to determine their equivalence to that of the U.S., and obtain clearance of FDA document through other federal agencies with vested involvement in U.S. equivalence criteria. B
3.3 3.3.6 Food and Cosmetic Information Line: Develop Spanish Language Option for CFSAN's Food and Cosmetic Information Line to ensure that Spanish –speaking callers will have access to more consumer information on food safety. B
3.3 3.3.7 Proposal to Consider Adoption of Codex Standards: Review current 21 CFR language regarding acceptance of Codex standards, develop options for revision to existing language. B

 

Food Biotechnology
Strategy Sub Strategy Goal Description Priority Level
3.4 3.4.1 Convene the subcommittee on biotechnology of the CFSAN Food Advisory Committee to discuss issues concerning the evaluation of allergenicity in relation to bioengineered food. A
3.4 3.4.2 Develop a final rule for the biotechnology notification program. B*
3.4 3.4.3 Develop final guidance for voluntary labeling of foods that have or have not been developed using bioengineering. B*
3.4 3.4.4 Develop guidance on the use of antibiotic resistance genes in bioengineered plant foods. B*
3.4 3.4.5 Develop guidance concerning the potential presence of unintended varieties of bioengineered plant foods that may be present in the food supply, but that have themselves not completed all regulatory steps for marketing. B
3.4 3.4.6 Develop draft guidance on allergenicity in relation to bioengineered food, taking into account recommendation of the Food Advisory Committee. B

 

Internal Processes
Strategy Sub Strategy Goal Description Priority Level
3.5 3.5.1 CFSAN Adverse Events Reporting System (CAERS):
3.5 3.5.1 a. Develop standard operating procedures and pilot test new systems for the processing of adverse events. A
3.5 3.5.1 b. Establish a system that makes adverse event reports promptly available to manufacturers, including the timely redaction of confidential information. A
3.5 3.5.2 Compliance/Enforcement: Improve CFSAN's response time to recommended regulatory actions through the development of better-defined roles and responsibilities across the Program Offices. A
3.5 3.5.3 CFSAN-Field Relations: Improve enforcement strategies through field, program office and CFSAN's Office of Field Programs interaction(s) as well as analysis and evaluation of inspection findings, sampling, and survey and investigation data. Develop enforcement expertise through proper staffing, structure, training and processes. A
3.5 3.5.4 Correspondence Control: Make enhancements to the Center's correspondence control process by improving the internal coordination of information to ensure the orderly, timely, and coordinated response to internal and external communications. A
3.5 3.5.5 Regulations Process: Evaluate the CFSAN regulations development SOPs in order to make additional refinements to promote quality and efficiency in all stages of the regulations development process within CFSAN and improved coordination with the Office of the Chief Counsel. B

 

Focused, Economic-based Regulations
Strategy Sub Strategy Goal Description Priority Level
3.6 3.6.1 Report to Congress on the status of petition requesting the promulgation of a new standard of identity for yogurt. A
3.6 3.6.2 Report to Congress on current work as it relates to enforcement of standards of identity as it relates to cheese. A
3.6 3.6.3 Develop proposed rule on guiding principles for standards of identity in collaboration with USDA. B*
3.6 3.6.4 Develop both a final regulation (for most aspects) and proposed regulation (for some aspects) on a standard of identify for crabs/names of crabs. B*
3.6 3.6.5 Develop a proposed regulation on standard of fill for tuna. B*
3.6 3.6.6 Develop final rule to establish a standard of identity for white chocolate. B*
3.6 3.6.7 Develop proposed regulation for standard of identity for scallops. B
3.6 3.6.8 Develop a new compliance policy guide for fresh and frozen shrimp. B
3.6 3.6.9 Develop proposal to amend definition for "milk" in cheese Standards to provide for use of fluid filtered milk. B

 

EEO/Diversity
Strategy Sub Strategy Goal Description Priority Level
3.7 3.7.1 Implement CFSAN Hispanic Action Plan. A
3.7 3.7.2 Develop additional strategies to increase the diversity of the CFSAN workforce, including addressing under-representation and career potential of African-American males within CFSAN; increasing employment of individuals with disabilities in accordance with Executive Order 13078; and implementing and monitoring progress toward increased diversity using committees with cross cutting membership within CFSAN. B

 

Management Initiatives
Strategy Sub Strategy Goal Description Priority Level
3.8 3.8.1 Recruitment and Hiring: Implement the FY 2002 Recruitment Plan that will assist the Center in attracting and identifying potentially qualified applicants into the FDA and CFSAN application pools. A
3.8 3.8.2 National Treasury Employee Union (NTEU): Continue to work with NTEU and the Partnership Committee to fully implement the NTEU Collective Bargaining Unit Agreement. A
3.8 3.8.3 Quality of Worklife (QWL) Initiative: Continue the QWL initiative to provide mechanisms for improved communication and quality of worklife. B
3.8 3.8.4 Integrated Financial Management System Enhancement: Continue the implementation of the new automated financial management system. B
3.8 3.8.5 Issuance and Maintenance of Directives: Improve the Center's process for developing and implementing Policy and Procedure Guidance. B
3.8 3.8.6 Information Technology: Establish software to integrate the FDA EASE core person data into CFSAN administrative databases. B
3.8 3.8.7 Information Technology: Provide ease of access and management of security rights for the evolving CFSAN Enterprise database being developed using Oracle to be in compliance with FDA ISA standards. B
3.8 3.8.8 Information Technology: Provide ease of access and management of security rights for the evolving CFSAN Enterprise database being developed using Oracle to be in compliance with FDA ISA standards. B

 


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