U. S. Department of Health and Human Services
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
March 10, 2003


CFSAN 2003 Program Priorities

Letter from Center Director
Table of Contents

Dear Colleague, FDA Foods Community

Again this year, I am pleased to share with you the FY 2003 Program Priorities for FDA's Center for Food Safety and Applied Nutrition (CFSAN). This document lays out the Center's work product expectations for the current fiscal year 2003 (October 1, 2002 through September 30, 2003), and, as always, is based on input we received from you (our stakeholders) as well as input generated internally, with focus on the question: "Where do we do the most good for consumers?" On behalf of CFSAN, I thank you for your input and your continuing interest in this process.

The current 2003 work plan is organized in a tabular format similar to the 2002 work plan and under the following headings:

  1. Assuring Food Safety and Security
  2. Assuring Food & Cosmetic Safety & Improving Nutrition: Specific Program Areas
  3. Assuring Food Safety: Crosscutting Areas

This year, as with last, our work plan focuses heavily on ensuring the security of our country's food supply as a primary goal. With the enactment last June of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, much of our effort during the current fiscal year will focus on issuing the necessary regulations to implement this statute. For example, the Food Safety and Security section of our work plan prominently features the issuance of proposals and final rules (along with necessary guidance) for the four major areas of the new legislation, namely, facility registration, prior notice, record keeping, and administrative detention. We will also continue to enhance our level of emergency preparedness, particularly our laboratory preparedness.

This year's plan also highlights our desire to revitalize our Nutrition program. In December 2002, FDA announced a major initiative to enhance Consumer Health Information for Better Nutrition by extending the applicability of qualified health claims to conventional foods. Accordingly, this year's plan includes the steps needed to implement that initiative, including increased enforcement against unsubstantiated claims on food or dietary supplement products. This plan is our most ambitious one yet, with a total of 145 "A-list" goals, our so-called "boulders." These are listed in bold-face type in the document. These A-list items are reasonably well divided between Food Security (23), Food Safety (39), Specific Program Areas (44), and Cross-Cutting issues (39). Our goal is to complete at least 90 percent of these "A-List" items by the end of the current fiscal year, September 30, 2003.

To delineate as clearly as possible between what we can commit to complete this year and other important work that must also go on, we have eliminated the use of "asterisked" B items from this year's plan. Thus, all projects in this plan are either "A-list" or "B-list" items. 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. Many of these are multi-year projects that we expect to place on the "A-list" in subsequent years.

This work plan does not address the myriad of unanticipated issues that also require a substantial investment of CFSAN resources (e.g., responses to outbreaks of foodborne illness), as well as our many ongoing enforcement, research and communication activities. As in the past, I will provide you with a mid-year progress report that will include any needed adjustments.

I again thank you, our many stakeholders, for your continuing support. I believe this process is central to our goal of building CFSAN into a World Class Organization. I look forward to working with you as we strive to 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 & Cosmetic Safety & Improving Nutrition: Specific Program Areas

  3. Assuring Food Safety: Crosscutting Areas

 

Part I
Assuring Food Safety and Security

Contents - Priority Areas

Food Security: Implementing New Legislation
Food Security: Emergency Preparedness
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)
Game Meat
Food Allergens
Dairy Safety
Education

Priority Areas

Food Security: Implementing New Legislation
  Strategy Sub Strategy Goal Description Priority Level
Regulations 1.1 1.1.1 Issue a proposed rule for the establishment of food facility registration requirements for all domestic and foreign facilities engaged in manufacturing, processing, packing and holding of food. A
1.1 1.1.2 Issue a proposed rule for the establishment of prior notification requirements for all imported food shipments. A
1.1 1.1.3 Issue a proposed rule for the establishment and maintenance of records to identify immediate previous source and immediate subsequent recipient of foods. A
1.1 1.1.4 Issue a proposed rule for the establishment of administrative detention requirements. A
1.1 1.1.5 Develop and implement an outreach plan for the four Bioterrorism proposed rules to domestic and international stakeholders and encourage their comments. A
1.1 1.1.6 Issue a final rule for the establishment of food facility registration requirements for all domestic and foreign facilities engaged in manufacturing, processing, packing and holding of food. (Target Date for publication: October 12, 2003). A
1.1 1.1.7 Issue a final rule for the establishment of prior notification requirements for all imported food shipments. (Target Date for publication: October 12, 2003). A
1.1 1.1.8 Develop a final rule for the establishment and maintenance of records to identify immediate previous source and immediate subsequent recipient of foods. (Target Date for publication: December 12, 2003). B
1.1 1.1.9 Develop a final rule for the establishment of administrative detention requirements. (Target Date for publication: December 12, 2003). B
Guidance 1.1 1.1.10 Issue for public comment, industry and field staff guidances to implement authorities under the Bioterrorism Act (P.L. 107-188) in effect as of July 2002. A
1.1 1.1.11 Develop guidance for the establishment of food facility registration requirements for all domestic and foreign facilities engaged in manufacturing, processing, packing and holding of food. B
1.1 1.1.12 Develop guidance for the establishment of prior notification requirements for all imported food shipments. B
1.1 1.1.13 Develop guidance for the establishment and maintenance of records to identify immediate previous source and immediate subsequent recipient of foods. B
1.1 1.1.14 Develop guidance for the establishment of administrative detention requirements. B
IT Systems 1.1 1.1.15 Design and build, in conjunction with the Office of Regulatory Affairs (ORA), the food facility registration system as a requirement of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. A
1.1 1.1.16 Design and build, in conjunction with ORA, the electronic system to support prior notification requirements for all imported food shipments as a requirement of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. A
Reports to Congress 1.1 1.1.17 Complete food security section of the FDA counter terrorism research report to Congress. A
1.1 1.1.18 Submit a Report to Congress on the external threat assessment of intentional adulteration of food, developed under contract with FDA [Public Health Security and Bioterrorism Preparedness and Response Act of 2002] (P.L. 107-188). A

Food Security: Emergency Preparedness
  Strategy Sub Strategy Goal Description Priority Level
Laboratory Preparedness 1.2 1.2.1 Evaluate rapid analytical tests for their application to foods. A
1.2 1.2.2 In conjunction with ORA, other federal agencies and the states, support the development, including training, of a nationwide Laboratory Response Network (LRN) for food. A
1.2 1.2.3 Develop research needs to enhance emergency preparedness against possible terrorists threats. B
Response Capability 1.2 1.2.4 In conjunction with FDA's Office of Crisis Management (OCM), enhance CFSAN emergency response by revising the response plan, improving information flow, and drafting template consumer messages. A
1.2 1.2.5 Continue to participate in emergency response exercises. A
Guidance to Industry 1.2 1.2.6 Revise and finalize the industry food safety and security guidance documents (domestic facilities and importers) based on comments to January 9, 2002 Federal Register Notice. A
1.2 1.2.7 Issue draft guidance on food safety and security for the retail food and cosmetics sectors. A
1.2 1.2.8 Enhance coordination of food security and counter-terrorism issues with federal, state, and local governments and other organizations, including leadership in the Food Threat Preparedness Network (PrepNet). A
Facility Security 1.2 1.2.9 Upgrade two facilities, MOD-I and NCFST, to BL3 safety level and implement and enhance security plan for all CFSAN laboratories. A
1.2 1.2.10 Situation Room: complete the architectural drawings and renovations for making the situation room fully operational by February 28, 2003. A
1.2 1.2.11 Secure Communications Room: Complete the architectural drawings and renovations for sound proofing the secure communications room by February 28, 2003. A
1.2 1.2.12 MOD 1 Alternate site: complete cabling and renovations of the space identified as the CFSAN alternate worksite. A

Domestic Inspections
Strategy Sub Strategy Goal Description Priority Level
1.3 1.3.1 In conjunction with ORA, inspect 95% of all domestic firms that produce "high-risk" foods. A
1.3 1.3.2 Continue to implement multi-year strategy to enhance FDA audit and evaluation of State inspection programs. A
1.3 1.3.3 Evaluate results of FY 2002 "high-risk" inspections. Make recommendations on whether the program is accomplishing its objective and identify where and how the program needs to be improved. A

Imports and Foreign Inspections
Strategy Sub Strategy Goal Description Priority Level
1.4 1.4.1 In conjunction with the Office of Regulatory Affairs, perform 48,000 physical exams and conduct sample analyses on products with suspect histories. A
1.4 1.4.2 Conduct 225 - 250 foreign inspections, with "high-risk" foods as a top priority. A
1.4 1.4.3 In conjunction with ORA, complete the evaluation and classification of foreign firms inspections. A
1.4 1.4.4 Issue an Import Bulletin, which defines the criteria for increasing the scrutiny of imported food products from firms that refuse to allow FDA to inspect their facilities. B
1.4 1.4.5 Develop a proposed rule to set standards for the use of private laboratories and for testing imported foods. B
1.4 1.4.6 Amend 21 CFR 1.90 to allow discretion to release import samples prior to completion of analysis. Develop standard operating procedures implementing change in 21 CFR 1.90. B

Seafood Safety
Strategy Sub Strategy Goal Description Priority Level
1.5 1.5.1 Revise consumer advisory on methylmercury in commercial seafood, acting upon the recommendations from the FDA Food Advisory Committee. A
1.5 1.5.2 Develop strategy to increase above the level of 85% the number of seafood processors that are in compliance with the seafood HACCP program. A
1.5 1.5.3 Continue to work with the ISSC to implement a control strategy for Vibrio vulnificus in raw oysters. A
1.5 1.5.4 Publish guidance to industry on the use of common or usual names for "Catfish" as a requirement of the Farm Security and Rural Investment Act of 2002. A
1.5 1.5.5 Make progress on the study of optimum seafood-based inspection frequency. B
1.5 1.5.6 Continue to compare equivalence of North American shellfish programs to the European shellfish programs. B
1.5 1.5.7 Continue project to develop good aquaculture practices to ensure that aquaculture waters are not a source of pathogens or other contaminants. B
1.5 1.5.8 Continue to work with the Interstate Shellfish Sanitation Commission (ISSC) to develop a final control strategy for Vibrio parahaemolyticus. B
1.5 1.5.9 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
1.5 1.5.10 Review petition from the Center for Science in the Public Interest requesting that FDA establish a microbial testing program for hazards in seafood products. B

Fruits and Vegetables
Strategy Sub Strategy Goal Description Priority Level
1.6 1.6.1 Assist the government of Mexico in developing a certification program to assure the safety of cantaloupe to be sold in the U.S. In the interim, expeditiously review firms' requests for removal from "Detention Without Physical Examination" submitted through the Mexican Embassy. As part of that process, conduct on-site inspections of Mexican firms requesting removal from Detention Without Physical Examination. A
1.6 1.6.2 Issue final guidance on the transport of concentrated juices. A
1.6 1.6.3 Issue Small Entities Guide for the Juice HACCP Regulation. A
1.6 1.6.4 Issue final guidance on Juice HACCP training curriculum. A
1.6 1.6.5 Finalize the 1st edition of the draft Juice Hazards and Controls Guide. A
1.6 1.6.6 Report to Congress on FDA's review of labeling requirements for products that claim to be orange juice when the orange juice content is 5 percent or less, including FDA's recommendation to create new juice labeling guidelines to avoid consumer confusion. A
1.6 1.6.7 Issue draft guidance for fresh-cut produce. A
1.6 1.6.8 Issue more limited guidance for fresh-cut produce, in conjunction with educational video produced with the California Department of Health Services. A
1.6 1.6.9 Develop strategy for addressing the multiple outbreaks of E. coli O157:H7 in domestic lettuce. A
1.6 1.6.10 Conduct international Good Agriculture Practices (GAP) outreach in conjunction with the Joint Institute for Food Safety and Applied Nutrition (JIFSAN). A
1.6 1.6.11 Improve the sensitivity of Salmonella detection methodology for cantaloupe. B
1.6 1.6.12 Work with relevant trade associations to develop GAPs and GMPs for cantaloupes. B
1.6 1.6.13 Prepare report evaluating the 1999 and 2000 sprout assignment. B
1.6 1.6.14 Produce and distribute video on safe juice processing with the California Department of Health Services. B
1.6 1.6.15 Amend sprouts guidance regarding mung bean irrigation water sampling and use of kits. B
1.6 1.6.16 In conjunction with ORA, continue issuing sampling assignments to analyze specific items of domestic and imported produce for the presence of pathogens. B

Egg Safety
Strategy Sub Strategy Goal Description Priority Level
1.7 1.7.1 Issue proposed egg safety rule to further reduce human illnesses from Salmonella Enteritidis. A
1.7 1.7.2 Hold public meetings on the proposed egg safety rule once it is issued. B
1.7 1.7.3 In collaboration with the Office of Crisis Management (OCM), develop a draft Salmonella Enteritidis (SE) Traceback Investigation Protocol. B
1.7 1.7.4 Prepare report on findings of past years' SE Traceback Inspections. B
1.7 1.7.5 Develop proposed rule to allow in-lid labeling for safe-handling instructions for shell eggs B

Listeria
Strategy Sub Strategy Goal Description Priority Level
1.8 1.8.1 Issue the revised risk assessment on Listeria monocytogenes contamination in ready-to-eat foods. A
1.8 1.8.2 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
1.9 1.9.1

In conjunction with FDA's Office of Regulatory Affairs, increase uniformity in regulations governing the retail segment of the food industry by:

  1. Achieve adoption of the Food Code by at least one state agency in 42 states in the USA

A
  1. Increasing the number of jurisdictions enrolled in the Voluntary Program Standards from 60 in FY2002 to 120.
 B
  1. Increasing the percentage of jurisdictions that have performed their self-assessments from 38% to 45%.
B
1.9 1.9.2 In conjunction with the Office of Regulatory Affairs (ORA), develop strategic plan/best model for administering the Interstate Travel Program and infrastructure to implement. B
1.9 1.9.3 Institute processes that improve the Shellfish and Grade A Milk Programs by establishing internal consensus-based mechanisms including Steering Committee participation with other internal partners. B

Chemical Contaminants, Pesticides and other Hazards
Strategy Sub Strategy Goal Description Priority Level
1.10 1.10.1 Complete development of, and begin to implement, FDA's action plan for acrylamide, including completion of the preliminary survey on occurrence in foods. A
1.10 1.10.2 Hold Food Advisory Subcommittee and Full Committee meetings to evaluate FDA's action plan for acrylamide in foods. A
1.10 1.10.3 In conjunction with ORA, issue assignment to analyze Total Diet Survey samples and other specific food samplers for acrylamide. A
1.10 1.10.4 Chloramphenicol: in conjunction with ORA, continue to collect and analyze samples of honey and seafood for the presence of chloramphenicol. A
1.10 1.10.5 Issue draft generic "channels of trade" guidance. A
1.10 1.10.6 Issue draft revised Compliance Policy Guide on radionuclides in foods to update existing levels and to add radionuclides. A
1.10 1.10.7 Collect and analyze 8000 food samples to maintain current level of monitoring for pesticides and chemical contaminants. A
1.10 1.10.8 Continue implementing FDA's dioxin strategy, including monitoring, method development and identifying opportunities to reduce exposure. A
1.10 1.10.9 Issue proposal/direct final rule for radionuclides quality standards for bottled water. A
1.10 1.10.10 Develop a proposal to revise the bottled water quality standards for arsenic. B
1.10 1.10.11 Develop reproposal on coliform quality standard for bottled water. B
1.10 1.10.12 Develop policy for ethyl carbamate in food. B
1.10 1.10.13 Update the pesticides Compliance Policy Guide to bring it in line with Food Quality Protection Act (FQPA). B
1.10 1.10.14 Develop improved analytical method for methyl mercury. B
1.10 1.10.15 Develop for the Internet the FDA Pesticide Monitoring data and summary information as required by the Pesticide Monitoring Improvement Act. B
1.10 1.10.16 Unify Agency clostridium botulinum policy for the wide variety of foods regulated by FDA. B

Transmissible Spongiform Encephalopathies (TSEs)
Strategy Sub Strategy Goal Description Priority Level
1.11 1.11.1 Develop the CFSAN portion of an Agency regulation banning use of bovine materials from BSE or BSE high-risk countries in CFSAN-regulated products. B
1.11 1.11.2 Continue to minimize human exposure to TSEs (BSE and CWD) from the use of bovine brain and spinal cord and determine potential of CWD infected cervids as a human health risk through collaboration with IFT/Harvard and CDC/Case Western Reserve and in cooperation with USDA, to also minimize exposure from animals 24 months or older in CFSAN-regulated products. B

Game Meat
Strategy Sub Strategy Goal Description Priority Level
1.12 1.12.1 In conjunction with the Office of Regulatory Affairs (ORA), identify manufacturers or processors of game meats and game meat products and then develop an inspection and sampling plan to evaluate sanitation practices. B

Food Allergens
Strategy Sub Strategy Goal Description Priority Level
1.13 1.13.1 Continue consumer and industry outreach to increase awareness of the presence of allergens in food and address the need for better reporting of allergen adverse events. A
1.13 1.13.2 Complete an Association of Official Analytical Chemists (AOAC) multi-laboratory performance validation of commercially available immunochemical peanut protein test kits and initiate an inter-laboratory study following the AOAC harmonized validation protocol. A
1.13 1.13.3 Publish 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. A
1.13 1.13.4 Hold Food Advisory Committee meeting on latex allergenicity issues, related to the use of natural rubber latex gloves by food handlers. A
1.13 1.13.5 Evaluate the FY 2002 food allergens inspections. A
1.13 1.13.6 Develop draft guidance on the use of test kits, for regulatory actions, to detect the presence of peanut protein for regulatory purposes. B
1.13 1.13.7 Develop proposed rule for the labeling of the most common allergens using consumer and industry input from the August 13, 2001, food allergen public meeting. B
1.13 1.13.8 Develop a comprehensive food allergen strategy to address considerations such as cross-contact problems (not including bioengineered foods). B

Dairy Safety
Strategy Sub Strategy Goal Description Priority Level
1.14 1.14.1 In collaboration with the Office of Regulatory Affairs and the Center of Veterinary Medicine, facilitate the implementation of the new National Drug Residue Milk Compliance Program (NDRMCP). B
1.14 1.14.2 Evaluate the science of raw milk cheeses. (60-day aging). B
1.14 1.14.3 Issue updated Federal Import Milk Act (FIMA) Compliance Policy Guide. B
1.14 1.14.4 Evaluate the science and determine the need to change existing Pasteurized Milk Ordinance (PMO) guidance on Vitamins A & D supplementation of Grade A dairy products. B
1.14 1.14.5 Continue to work toward completion of equivalence determinations with Canada and the EU. B
1.14 1.14.6 Develop guidance for the pasteurization treatment requirements of section 403(h)(3) [Farm Security and Rural Investment Act of 2002]. B

Education
Strategy Sub Strategy Goal Description Priority Level
1.15 1.15.1 Conduct one International Regional Food Safety Workshop to provide information on key U.S. food safety initiatives. A
1.15 1.15.2 In conjunction with the State of California and the ISSC, implement an education and outreach program on Vibrio for Hispanic men. A
1.15 1.15.3 Continue education and outreach on the risks of methylmercury in seafood to pregnant women and to heavy fish-eating populations. The education and outreach materials and messages will be adjusted when FDA revises its consumer advisory. B
1.15 1.15.4 Develop Food Safety Program for Pregnant Women. B
1.15 1.15.5 Develop and distribute Seafood Safety Education Materials. B


 

Part II
Assuring Food & Cosmetic Safety & Improving Nutrition:
Specific Program Areas

Contents - Priority Areas

Food and Color Additives: Premarket Review
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 2002, complete within 360 days of filing, the safety evaluation of 80% of those food and color additive petitions that qualify for expedited review. A
2.1 2.1.1 b. For the petition receipt cohort of FY 2002, complete within 360 days of filing, the safety evaluation of 70% of those food and color additive petitions that do not qualify for expedited review. A
2.1 2.1.1 c. Essentially eliminate the inventory of overdue food and color additive petitions by reducing to fewer than 10 the number of food and color additive petitions that were received prior to 10/1/2001. A
2.1 2.1.1 d. Complete CFSAN evaluation of biotechnology final consultations within 180 days. A
2.1 2.1.1 e. Complete processing of 80% of GRAS notifications (GRNs) within 180 days. A
2.1 2.1.1 f. Complete review of premarket notifications for food contact substances within the statutory time limit (120 days). A
2.1.2 Congressional Reports/Directives 2.1 2.1.2 a. Through the Office of Legislation, work with Congress to extend the authorization of appropriations (under the Food, Drug, and Cosmetic Act (FD&C Act) section 409(h)(5)) for the Food Contact Substance Notification Program beyond FY 2003. A
2.1 2.1.2 b. 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. Develop an enforcement strategy for ensuring that dietary supplement ingredients, when added to conventional foods, are lawful. A
2.1 2.1.3 b. Develop draft guidance on the preparation of Environmental Assessments or claims of categorical exclusion. B
2.1 2.1.3 c. Develop updated chemistry guidance for recycled plastics. B
2.1 2.1.3 d. Develop a Federal Register proposal extending exclusion from Environmental Assessments to additional categories of Agency action on food and color additives. B
2.1 2.1.3 e. Amend 21 CFR section 178.1010, as a result of the Food Quality Protection Act, to accommodate partial transfer of this regulation to EPA. B
2.1 2.1.3 f. Continue to communicate with prospective submitters to encourage prefiling consultations for new petitions. B
2.1 2.1.3 g. Develop guidance for biodegradable plastics. B
2.1 2.1.3 h. Develop proposed rule on recycled plastics. B
2.1 2.1.3 i. Develop guidance for packaging used when irradiating foods. B
2.1 2.1.3 j. Bromates: continue work on developing a strategy for regulating the use of bromates in baked goods and to respond to the pending citizen petition on bromates. B
2.1 2.1.3 k. Develop documents to adopt the specifications in the most recent edition of the Food Chemicals Codex into regulations as appropriate. B
2.1 2.1.3 l. Continue to make additional final revised Redbook Chapters available on the FDA website. B
2.1.4 Improve Efficiency/Responsiveness 2.1 2.1.4 a. Develop final guidance for the electronic submission of food and color additive petitions. B
2.1 2.1.4 b. Develop additional study review templates to facilitate the evaluation of toxicology/safety data submitted in food and color additive petitions and in food contact notifications. B
2.1 2.1.4 c. Develop a final rule for the GRAS notice program. B
2.1 2.1.4 d. Develop E-guidance document that would accompany the GRAS notification program final rule. B
2.1 2.1.4 e. Develop E-guidance document for the food contact substance notification program. B
2.1.5 Enforcement/Compliance 2.1 2.1.5 a. Publish a draft Compliance Policy Guide (CPG) for chloropropanols. A

Nutrition, Health Claims and Labeling
  Strategy Sub Strategy Goal Description Priority Level
2.2.1 Enhance Consumer Health Information for Better Nutrition 2.2 2.2.1 a. Publish guidance extending qualified health claims to conventional foods. A
2.2 2.2.1 b. Establish Agency-wide Task Force, chaired by FDA Deputy Commissioner and vice-chaired by CFSAN Director, to oversee implementation of this initiative. A
2.2 2.2.1 c. Issue guidance on "weight of scientific evidence." A
2.2 2.2.1 d. Develop procedures and staffing needs for timely review of qualified health claims petitions. A
2.2 2.2.1 e. Develop framework for proposed regulation governing qualified health claim petitions. A
2.2 2.2.1 f. Develop consumer studies research agenda. Initiate research to clarify how consumers perceive complex information on health claims, and increase collaboration with the Federal Trade Commission (FTC) to help ensure such claims are not misleading to consumers. A
2.2.2 Review of Industry Submissions/Statutory Requirements 2.2 2.2.2 a. Review premarket notifications for new infant formulas within statutory timeframe. A
2.2 2.2.2 b. Review nutrient content/ health claim notifications and petitions within statutory timeframe. A
2.2 2.2.2 c. Publish a final rule for stanol/sterol esters health claim. A
2.2 2.2.2 d. In response to the Farm Security and Rural Investment Act of 2002, develop a proposed rule to revise, as appropriate, the existing regulation that requires irradiated food to be labeled. B
2.2 2.2.2 e. Conduct a survey to identify and characterize the sources of caffeine in the food supply. B
2.2.3 Congressional Reports/Directives 2.2 2.2.3 a. Report to Congress on the health claim that "consumption of Omega 3 fatty acids in salmon can prevent and reverse heart disease." A
2.2.4 Protecting and Promoting Public Health with Agency Initiated Actions 2.2 2.2.4 a. Publish a final rule for trans fatty acid labeling. A
2.2 2.2.4 b. Publish an advance notice of proposed rulemaking (ANPRM) on an appropriate footnote for the food label to put Trans fatty acids into proper context with other dietary fat, and initiate research on how best to communicate this information to consumers. A
2.2 2.2.4 c. Publish proposal on the sodium provisions for the implied nutrient content claim "healthy." A
2.2 2.2.4 d. Reopen comment period on proposed rule for infant formula GMPs and quality factors. A
2.2 2.2.4 e. Convene meeting of the Food Advisory Subcommittee on Infant Formula. A
2.2 2.2.4 f. Convene meeting of the FDA Food Advisory Subcommittees on Infant Formula and on Contaminants and Toxicants to address issues pertaining to Enterobacter sakazakii. A
2.2 2.2.4 g. Convene meeting of the Food Advisory Subcommittee on Nutrition. A
2.2 2.2.4 h. Evaluate ways to make the nutrition label more effective in providing science based nutrition guidance to consumers. B
2.2 2.2.4 i. Monitor contract with the Institute of Medicine/National Academy of Sciences (IOM/NAS) to develop scientific rationale for methodology to be used to update reference values used in nutrition labeling and to review principles for discretionary fortification of foods based on new Dietary Reference Intake (DRI) values published by IOM/NAS. B
2.2 2.2.4 j. Develop final rule for infant formula GMPs and quality factors. B
2.2 2.2.4 k. Continue to clarify the nature of appropriate post-market surveillance for new/novel ingredients added to infant formula. B
2.2.5 Improve Efficiency/Responsiveness 2.2 2.2.5 a. Develop a final rule providing for more flexibility in the use of health/nutrient content claims in response to citizens' petitions. B
2.2 2.2.5 b. Develop proposed rule for nutrient content claims that are the subject of health claims. B
2.2 2.2.5 c. Develop final rule to update nutrient values for the voluntary nutrition labeling program. B
2.2.6 Enforcement/Compliance 2.2 2.2.6 a. Continue to conduct enforcement activities related to inappropriate labeling of conventional foods. 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. 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 Protecting and Promoting Public Health with Agency Initiated Actions 2.3 2.3.2 a. Publish proposed rule for dietary supplement GMPs. A
2.3 2.3.2 b. Conduct outreach on the proposed rule for dietary supplement GMPs. A
2.3 2.3.2 c. Convene meeting of the Food Advisory Subcommittee on Dietary Supplements. A
2.3 2.3.2 d. Continue to develop standard operating procedures (SOPs) to enhance timely identification and clinical assessment of dietary supplement adverse events and coordinate these efforts with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) in their respective capacities. B
2.3 2.3.2 e. Continue to develop mechanisms to enhance timely clinical assessment of dietary supplement adverse event investigations. B
2.3.3 Improve Efficiency/Responsiveness 2.3 2.3.3 a. Publish proposal/direct final rule to update current rule for common or usual botanical names used in dietary supplement labeling, in part to respond to Sec 10806 of the Farm Security and Rural Investment Act of 2002, which states that the term "ginseng" may only be used to identify plants classified within the genus Panax rule. A
2.3 2.3.3 b. Develop a strategy for dietary supplements that contain ephedrine alkaloids, based on report from RAND Corporation. A
2.3 2.3.3 c. Develop "Dietary Supplement Labeling Guide" for Industry. A
2.3 2.3.3 d. Develop guidance for industry on submissions of 75-day notifications for new dietary ingredients. B
2.3 2.3.3 e. Develop final rule on "per day" labeling for dietary supplements. B
2.3 2.3.3 f. Develop "Regulatory Guidebook" for industry. B
2.3.4 Enforcement/Compliance 2.3 2.3.4 a. Continue to identify dietary supplement ingredients/products that raise safety problems, and take appropriate enforcement actions. A
2.3 2.3.4 b. Expand efforts in conjunction with the Federal Trade Commission, to take action against unsubstantiated claims on dietary supplements. A
2.3 2.3.4 c. Conduct surveillance activities pertaining to pesticides/contaminants in dietary supplement products. B

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: Continue to 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. Color Additive Lakes (PRIA): Publish, for public comment, analysis of economic impact of proposed rule. A
2.4 2.4.1 d. Prepare plan, with stakeholder input, to revitalize FDA's Cosmetics Program. A
2.4 2.4.1 e. Color Additive Lakes: Develop a final rule permanently listing color additive lakes through FDA. B
2.4 2.4.1 f. Diethanolamine (DEA): Develop risk assessment approach. B
2.4 2.4.1 g. Cosmetic Product Safety: Support NTP/NCTR photocarcinogenicity testing of glycolic acid and salicylic acid. 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. A
2.4 2.4.2 b. Coordinate move activities and space needs for multiple site relocations of the Office of Cosmetics and Colors. A
2.4 2.4.2 c. Develop electronic tracking and filing system . oracle based, to improve workflow, document tracking and ease sharing of documents and information. B
2.4 2.4.2 d. Cosmetic Labeling: Develop a strategy for amending 701.3 (c)(2) to update sources for naming cosmetic ingredients. B
2.4 2.4.2 e. 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
2.4.3 Enforcement/Compliance 2.4 2.4.3 a. Review 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, prior to expiration of agreement June, 2003. A
2.4 2.4.3 b. Develop draft guidance for issuance of 21 CFR section 740.10 warnings for products formulated with ingredients that lack adequate safety substantiation. B


 

Part III
Assuring Food Safety:
Crosscutting Areas

Contents - Priority Areas

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

Priority Areas

Science Base
Strategy Sub Strategy Goal Description Priority Level
3.1 3.1.1 Appoint members to the Food Advisory Committee (FAC) and subcommittees. A
3.1 3.1.2 Conduct meetings of the Food Advisory Committee. A
3.1 3.1.3 Continue and expand the cooperative research agreement between CFSAN/FDA and the University of Mississippi's National Natural Products Research Center. A
3.1 3.1.4 Evaluate the JIFSAN program and align the major program elements under a unifying umbrella. A
3.1 3.1.5 Continue the food processing and packaging research and outreach programs at the National Center for food Safety and Technology (Moffett Center), with a focus on contemporary food safety and security issues. A
3.1 3.1.6 Work with the Centers for Disease Control and Prevention (CDC) to submit a Report to Congress on foodborne illness information summarizing planned, ongoing, or completed case-control studies that would determine the proportion of cases of bacterial pathogens, such as E. coli 0157, Salmonella, Listeria, and Campylobacter, attributable to meat, poultry, eggs, seafood, fruits, and vegetables. B
3.1 3.1.7 Develop a plan to establish baselines, long-term illness/death reduction objectives, and tracking mechanisms for both process and health outcome indicators for selected food or food handling practice/pathogen pairs for which the effectiveness of interventions required or recommended by FDA regulations or guidance can be clearly indicated. B
3.1 3.1.8 Human Subject Protection: Working with the Agency and the Department, enhance the protection of human subjects in clinical and other research related to CFSAN-regulated products. B
3.1 3.1.9 Provide technical assistance to program offices on advisory subcommittee operations. B
3.1 3.1.10 Develop proposal for enhancing academic Centers of Excellence. B
3.1 3.1.11 Develop a 5-year strategic plan for research on food safety, cosmetic safety, and dietary supplement safety, including closer and more effective coordination with the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). B
3.1 3.1.12 In conjunction with the Centers for Disease Control and Prevention (CDC), evaluate the CDC foodborne disease outbreak surveillance system data to identify and analyze outbreaks associated with FDA regulated products, for number of outbreaks, etiologic agents, morbidity and mortality, seasonality, geographic location, site of food preparation, contributing factors, and whether product is domestic or imported. The initial analysis, to be completed in FY 2003, will focus on a high priority area such as seafood associated outbreaks. B
3.1 3.1.13 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
3.1 3.1.14 Establish mechanism for coordination of analytical methods validation procedures. B
3.1 3.1.15 Complete tracking and customization phase of the Learning Management System. B
3.1 3.1.16 Develop CFSAN Leadership Training Program. B
3.1 3.1.17 Participate in the formation of the FDA/HHS University. B
3.1 3.1.18 Reengineer Quality Assurance/Good Laboratory Practices (QA/GLP) Program in support of the Agency's initiative on laboratory accreditation. B
3.1 3.1.19 Develop DNA Microarray test for rapid identification of selected pathogens in foods. B
3.1 3.1.20 Develop a draft Dietary Supplement Research Agenda. B

International
Strategy Sub Strategy Goal Description Priority Level
3.2 3.2.1 Codex Committees and Working Groups: Participate in and assure FDA/CFSAN visibility in the Codex committees, ad-hoc task forces, related drafting and working groups, and scientific advisory committees meeting in FY 2003 that are of relevance to FDA/CFSAN. High priority attention to the following:  
Commission Sessions: 1. Special Session (25th) of the Codex Alimentarius Commission A
2. Regular Session (26th) of the Codex Alimentarius Commission A
Cross-cutting General Subject Committees: 3. Nutrition and Foods for Special Dietary Use (Delegate) A
4. Food Import and Export Inspections and Certification Systems (Delegate) A
5. Food Hygiene (Delegate) A
6. Food Additives and Contaminants (Delegate) A
7. General Principles (Alternate Delegate) A
8. Food Labeling (Delegate) A
9. Fats and Oils (Delegate) A
Task Forces: 10. Foods Derived from Biotechnology (Delegate) A
11. Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices (Delegate) A
Regional Coordinating Committee: 12. North American Southwest Pacific Regional Coordinating Committee A
Trilateral U.S./Canada/Mexican Activities: 13. Technical Working Group for Food Labeling, Packaging and Standards. A
3.2 3.2.2 Working in concert with FDA's Office of International Programs (OIP), ensure that effective communication at appropriate levels occurs with the Office of the United States Trade Representative (USTR) regarding food safety/trade issues, so that the U.S. government can 1) speak/act in concert and with a single voice and 2) use its resources efficiently in negotiating upcoming free trade agreements that will be forged in line with U.S. laws and policies. B
3.2 3.2.3 Export Certificates: Work with States, other federal agencies, and industry to increase transparency of U.S. systems for issuance of food export certificates. Continue to lead the Association of Food and Drug Officials (AFDO) Export Certificate Working Group. B
3.2 3.2.4 Coordination of International Technical Assistance: Review existing technical assistance efforts within CFSAN to determine how best to coordinate these activities to increase effective outreach, optimize use of CFSAN's human resources, leverage through partnerships with other institutions and federal agencies, and provide accessible data on these activities. B
3.2 3.2.5 Equivalence Criteria: Develop Agency criteria concerning equivalence. B
3.2 3.2.6 Develop proposal to consider adoption of Codex standards. B

Food Biotechnology
Strategy Sub Strategy Goal Description Priority Level
3.3 3.3.1 Convene a public meeting of the Food Biotechnology Subcommittee of the Food Advisory Committee to discuss current agency activities in food biotechnology. A
3.3 3.3.2 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. A
3.3 3.3.3 Work with appropriate FDA components and other U.S. Government agencies to develop a strategy to ensure that materials derived from non-food use bioengineered plants, such as pharmaceutical or industrial-use crops, do not adulterate the food supply. A
3.3 3.3.4 Develop final guidance for voluntary labeling of foods that have or have not been developed using bioengineering. B
3.3 3.3.5 Develop a final rule for the biotechnology notification program. B
3.3 3.3.6 Develop guidance on the use of antibiotic resistance genes in bioengineered plant foods. B
3.3 3.3.7 Develop guidance on allergenicity in relation to bioengineered food, taking into account recommendation of the Food Advisory Committee. B
3.3 3.3.8 Develop an E-guidance document that would accompany the biotechnology notification program final rule. B

Internal Processes
Strategy Sub Strategy Goal Description Priority Level
3.4 3.4.1 CFSAN Adverse Events Reporting System (CAERS): Finalize operational and functional tasks associated with executing its implementation. Target Date: end of June 2003. A
3.4 3.4.2 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
3.4 3.4.3 Warning Letters: Reduce average warning letter review times by CFSAN staff by the end of FY 2003. A
3.4 3.4.4 Regulations Process: Finalize the standard operating procedures that will promote quality and efficiency in all stages of the "Regulations and Related Documents Development Process" within CFSAN and improve coordination with the Office of the Chief Counsel, the Office of Regulatory Affairs, and the Office of the Commissioner. A
3.4 3.4.5 Provide training for CFSAN employees on the revised SOP's for developing regulations and related documents. A
3.4 3.4.6 Governmentwide Paperwork Elimination Act (GPEA): Implement Low Acid Canned Food and Food and Color Additive Petition electronic submission capability via the internet to meet GPEA requirements for industry. A

Focused, Economic-based Regulations
Strategy Sub Strategy Goal Description Priority Level
3.5 3.5.1 Publish an Advanced Notice of Proposed Rulemaking to seek comments on amending the standard of identity for yogurt. A
3.5 3.5.2 Publish proposed rule on general principles for standards of identity in collaboration with USDA. A
3.5 3.5.3 Develop proposed rule to amend definition for "milk" in cheese standards to provide for use of fluid ultra-filtered milk. A
3.5 3.5.4 Develop a new compliance policy guide for decomposition in fresh and frozen shrimp. B

EEO/Diversity
Strategy Sub Strategy Goal Description Priority Level
3.6 3.6.1 "Affirmative Employment Program":  Develop strategies in accordance with (1) Executive Order 11478 which mandates that equal employment opportunity be an integral part of every aspect of personnel policy and practice in the recruitment, hiring and retention of minorities, women and people with disabilities and (2) the Civil Service Reform Act of 1978 which mandates that the nations' workforce reflect the diversity of the nation as a whole. A
3.6 3.6.2 Diversity Initiative: Develop additional strategies to increase the diversity of the CFSAN workforce, through the use of mentoring, individual development plans and internships. Monitor progress toward increased diversity using committees with cross cutting membership within CFSAN. B

Management Initiatives
Strategy Sub Strategy Goal Description Priority Level
3.7 3.7.1 President's Management Initiative: Implement CFSAN-specific tasks as identified under the President's Management Initiative. A
3.7 3.7.2 Shared Services Organization (SSO) in FDA: Participate in the development and implementation of the "Shared Services" Initiative of consolidating FDA's administrative support functions. A
3.7 3.7.3 Complete the transfer of CFSAN Personnel Staff from the College Park facility to FDA Headquarters in Rockville, MD. A
3.7 3.7.4 National Treasury Employee Union (NTEU): Continue to work with NTEU and the Cooperation Council to fully implement the NTEU Collective Bargaining Unit Agreement. A
3.7 3.7.5 College Park: MOD I/BRF/Chantilly, VA: continue the program to relocate CFSAN personnel to State-of-the-art facilities. A
3.7 3.7.6 CFSAN Outreach and Information Center: finalize (1) remaining tasks associated with the move of the Outreach Center from CFSAN's FB-8 site and (2) all functional tasks needed to bring to full operation at the Wiley Building, College Park. A
3.7 3.7.7 Continue efforts to decommission Federal Office Building 8 in preparation for returning it to the General Services Administration. A
3.7 3.7.8 Convert all CFSAN staff utilizing Network Remote Access to the new Secure Remote Access system. A
3.7 3.7.9 Financial Management System Enhancement: Continue the implementation and enhancement of the new automated financial management system. Provide FTE and dollar support to the DHHS Unified Financial Management System. B
3.7 3.7.10 Quality of Worklife (QWL) Initiative; Continue the QWL initiative to provide mechanisms for improved communication and quality of worklife. B
3.7 3.7.11 Information Technology: Develop a CFSAN portal to provide single sign-on access to the CFSAN Intranet and Enterprise databases. B
3.7 3.7.12 Center Policy and Procedure Initiative: Expand to provide digital/internet access to the Center's policy and procedure guides. B
3.7 3.7.13 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 Integrated Systems Architecture (ISA) standards. B
3.7 3.7.14 Administrative Support Advisory Committee (ASAC): Continue to work with CFSAN's administrative/support staff to enhance the importance of the support staff, develop and improve internal procedures and guidelines (e.g., customer service, correspondence, travel, and training opportunities). B

CFSAN Activities
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