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December 1, 2004

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CFSAN 2005 Program Priorities

Letter from Center Director
Table of Contents

Dear Colleague, FDA Foods Community

I am pleased to share with you the FY 2005 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 2005 (October 1, 2004 through September 30, 2005), and is based on comments we received from you (our stakeholders) as well as comments generated internally, with focus on the question: "Where do we do the most good for consumers and the overall public health?" On behalf of CFSAN, I thank you for your comments and your continuing interest in this process.

Our work plan is divided into five primary sections: 

  1. Ensuring Food Safety and Defense
  2. Improving Nutrition and Dietary Supplement Safety
  3. Ensuring Food/Color Additive and Cosmetic Safety
  4. Ensuring Food Safety: Crosscutting Areas
  5. Priority Ongoing Activities

Food Safety and Defense remains a central theme in the Administration's public health agenda.  Our work plan reflects this continued focus.  We will continue to concentrate on the issuance of final rules for the four major areas of the Bioterrorism Act of 2002 legislation and will continue our efforts to establish prevention measures or "shields" for commodities and food products identified as a high security concern.

This year's plan reflects the same commitment as last year to revitalize and bolster our nutrition program.  Helping consumers improve their nutrition is an increasingly urgent part of the FDA mission.  Our efforts continue to focus on improving the health of the public by empowering people in the many choices they make every day that affect their health.  We are committed to working harder than ever to make sure the information consumers receive is scientifically valid and easily understood.

This work plan was developed in recognition of the diminished food safety budget yet still focusing on high priority areas that ensure the safety of our foods.  Our plan includes 123 "A-list" goals.  These are listed in bold-face type in the document.   Our goal is to complete at least 90 percent of these "A-List" items by the end of the current fiscal year, September 30, 2005.  Activities on the "B-list" are those we plan to make significant progress on, but which we may not complete before the end of the fiscal year.  Many of these are multi-year efforts that we anticipate placing on the "A-list" in subsequent years.  This year our priorities contain a new category.  This category is entitled "Priority Ongoing Activities" and it is intended to illustrate some of the many high priority activities that the Center performs on a regular basis in addition to those identified in our A-list and B-list priorities.

Beyond these there are still many activities that our plan does not address but that support our food safety mission.  These include ongoing regulatory, enforcement, research and communication activities as well as the myriad of unanticipated issues that also require a substantial investment of CFSAN resources (e.g., responses to outbreaks of foodborne illness).  At mid-year, a progress review will be conducted and I will provide you with a mid-year progress report that will include any needed adjustments.

I cannot thank you, our stakeholders, enough for your continuing support.  I believe that working together we can rise to the challenge of making sure Americans continue to enjoy a safe and healthy food supply. 

Sincerely,

Robert E. Brackett, Ph.D.
Director
Center for Food Safety and Applied Nutrition

Table of Contents

  1. I. Ensuring Food Safety and Defense

    • Food Safety Implementing Regulations and Guidance
    • Food Defense: Emergency Preparedness
    • Imports
    • Seafood Safety
    • Fruits and Vegetables
    • Egg Safety Action Plan
    • Listeria
    • Cooperative Programs
    • Chemical Contaminants, Pesticides and Other Hazards
    • Transmissable Spongiform Encephalopathies (TSEs)
    • Game Meats
    • Food Allergens
    • Dairy Safety
    • Education

  2. II. Improving Nutrition and Dietary Supplement Safety

    • Nutrition, Health Claims and Labeling
    • Dietary Supplements

  3. III. Ensuring Food/Color Additive and Cosmetic Safety

    • Food and Color Additives: Premarket Review
    • Cosmetics

  4. IV. Ensuring Food Safety: Crosscutting Areas

    • Science Base
    • International
    • Internal Processes
    • Focused, Economic-based Regulations
    • Management Initiatives

  5. V. Priority Ongoing Activities

Part I
Ensuring Food Safety and Defense

Contents

Food Defense/Food Safety Implementing Regulations and Guidance
Food Defense: Emergency Preparedness
Imports
Seafood Safety
Fruits and Vegetables
Egg Safety Action Plan
Listeria
Cooperative Programs
Chemical Contaminants, Pesticides and Other Hazards
Transmissable Spongiform Encephalopathies (TSEs)
Game Meats
Food Allergens
Dairy Safety
Education

Priority Areas

Food Defense/Food Safety Implementing Regulations and Guidance
  Strategy Sub Strategy Goal Description Priority Level
Regulations 1.1 1.1.1 Publish 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. A
1.1 1.1.2 Publish a final rule for the establishment of prior notification requirements for all imported food shipments. A
1.1 1.1.3 Publish a final rule for the establishment and maintenance of records to identify immediate previous source and immediate subsequent recipient of foods. A
Guidance 1.1 1.1.4 Publish FDA guidance procedures to access records under the new regulation authorizing the establishment and maintenance of records under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. A
1.1 1.1.5 Publish Small Entity Compliance Guide for the establishment and maintenance of records under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.  A
1.1 1.1.6 Issue Guidance for Administrative Detention under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.  A
1.1 1.1.7 Develop domestic and international plan and strategy for outreach to stakeholders/industry regarding Bioterrorism rules, new regulatory requirements and guidance.  A

Food Defense: Emergency Preparedness
  Strategy Sub Strategy Goal Description Priority Level
Laboratory Preparedness 1.2 1.2.1 Establish Laboratory Response Network (LRN) training assistance with federal and state counterparts. B

Imports
Strategy Sub Strategy Goal Description Priority Level
1.3 1.3.1 Publish final rule to set standards for the use of private laboratories and for testing imported foods. A
1.3 1.3.2 Redesign import operations and establish processes and procedures to ensure import enforcement resources are results oriented, risk-based, and can be quickly redirected to meet emerging problems. A

Seafood Safety
Strategy Sub Strategy Goal Description Priority Level
1.4 1.4.1 Publish analysis of all data gathered to date world-wide on the good aquaculture practices project in preparation for the drafting of guidance. A
1.4 1.4.2 Publish final Vibrio parahaemolyticus risk assessment. A
1.4 1.4.3 In cooperation with the Vibrio parahaemolyticus (Vp) Subcommittee of the Interstate Shellfish Sanitation Conference, develop a strategy to revise the interim control plan for the control of Vp in raw molluscan shellfish, based on the findings in the FDA Vp risk assessment. A
1.4 1.4.4 Complete an evaluation of program performance through the sixth year, with an emphasis on identifying factors that may be inhibiting improvements in compliance rates, in order 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 1.4.5 Develop 4th edition of the Fish and Fishery Products Hazards and Controls Guide. B
1.4 1.4.6 Review and prepare response to 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
1.5 1.5.1 Publish a "White Paper" for Food Current Good Manufacturing Practices (CGMPs). A
1.5 1.5.2 Issue draft guidance for fresh cut produce. A
1.5 1.5.3 Hold a public meeting on sprout safety and initiate rulemaking (ANPRM) for sprouts. A
1.5 1.5.4 Evaluate testing protocol for the recovery of Salmonella in sprout seeds. A
1.5 1.5.5 Issue guidance on enforcement discretion for ozonation of juice.  A
1.5 1.5.6 Provide assistance to California Department of Health Services (CDHS) on production of the video on safe juice processing. A
1.5 1.5.7 Develop a unified Clostridium botulinum policy for the wide variety of foods regulated by FDA. B
1.5 1.5.8 Work with USDA, Animal Plant Health Inspection Service (APHIS) and mango producers to institute practices to ensure safe handling of mangoes. B
1.5 1.5.9 Issue final fresh cut produce guidance. B
1.5 1.5.10 Issue report on sprout assignment. B
1.5 1.5.11 Issue assignment to sample mung beans intended for sprouting.  B

Egg Safety Action Plan
Strategy Sub Strategy Goal Description Priority Level
1.6 1.6.1 Publish proposal to permit "in-lid" labeling for the Safe Handling Statement on shell eggs. A
1.6 1.6.2 Hold public meetings on the proposed egg safety rule. A
1.6 1.6.3 Develop Egg Safety final rule for publication in FY 2006. A
1.6 1.6.4 Develop and issue a field assignment for the inspection of egg facilities. B

Listeria
Strategy Sub Strategy Goal Description Priority Level
1.7 1.7.1 Submit to Congress a copy of the report for the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) on the necessary scientific parameters for establishing safety-based use by dates for refrigerated ready-to-eat foods to help reduce the incidence of foodborne listeriosis. A
1.7 1.7.2 Issue draft guidance advising processors on steps to reduce Listeria monocytogenes (Lm) contamination in ready-to-eat foods. A
1.7 1.7.3 In collaboration with FDA's Office of Regulatory Affairs (ORA), perform targeted inspections of dairy products manufacturers with an emphasis on raw milks, creams, butters and margarines, soft unripened cheeses and fresh soft cheeses. A
1.7 1.7.4 Develop an action plan to address the large scale unlawful importation of cheeses. A
1.7 1.7.5 Issue a field assignment regarding "gourmet" raw milk soft cheeses. A
1.7 1.7.6 Respond to a Citizen petition (Docket No. 2003P-0574) to establish a regulatory limit of 100 colony forming units per gram for Listeria monocytogenes in foods that do not support the growth of the microorganism.   A
1.7 1.7.7 Develop Listeria guidance specifically for the dairy industry. B
1.7 1.7.8 Conduct a quantitative risk assessment (product pathway analysis) for Listeria monocytogenes (Lm) in smoked seafood. B
1.7 1.7.9 Work in conjunction with the Conference for Food Protection (CFP) to evaluate the current Food Code provisions and ascertain the need for modifications or additions to improve the control of Listeria monocytogenes (Lm) at retail. B

Cooperative Programs
Strategy Sub Strategy Goal Description Priority Level
1.8 1.8.1 Complete and publish the 2005 FDA Retail Food Code.   A
1.8 1.8.2 Increase the number of state and local Retail Food Regulatory Programs that are using risk-based inspection programs by 50%, as measured by the Voluntary National Retail Food Regulatory Program Standards. A
1.8 1.8.3 Increase the number of jurisdictions enrolled in the Voluntary National Retail Food Regulatory Program Standards from 120 in FY 2004 to 180. A
1.8 1.8.4 Complete and publish a report of the results of the 2003 survey of Foodborne Illness Risk Factors in (retail-level) Food Establishments. A
1.8 1.8.5 Develop a strategy to engage our stakeholders in meeting World Trade Organization (WTO) commitments that effect Cooperative Programs' regulatory infrastructure. A
1.8 1.8.6 Draft 2005 PMO and ISSC Model Ordinances. A

Chemical Contaminants, Pesticides and Other Hazards
Strategy Sub Strategy Goal Description Priority Level
1.9 1.9.1 In conjunction with FDA's Office of Regulatory Affairs (ORA), conduct survey of foods for perchlorate. A
1.9 1.9.2 Expand application of analytical methods for perchlorate to additional high priority foods.  A
1.9 1.9.3 Report to Congress on the findings of the perchlorate surveys of food and bottled water. A
1.9 1.9.4 Issue proposed rule to revise the bottled water quality standards for arsenic. A
1.9 1.9.5 Issue a final rule to revise the bottled water quality standards for arsenic. A
1.9 1.9.6 Issue draft revised guidance for lead levels in candy. A
1.9 1.9.7 Issue revised final guidance for lead levels in candy. A
1.9 1.9.8 Develop action plan for furan in foods. A
1.9 1.9.9 In collaboration with ORA, conduct expanded survey for furan in heat-processed foods and assess the effects of commonly employed cooking methods on the levels of furan in selected foods. A
1.9 1.9.10 Issue final generic "channels of trade" guidance. A
1.9 1.9.11 Update the pesticides Compliance Policy Guide (CPG) to bring it in line with Food Quality Protection Act (FQPA). A
1.9 1.9.12 Conduct workshop on exposure assessment methodologies and practices in support of the World Health Organization/Food and Agriculture Organization (WHO/FAO) project to update the principles of risk assessment for chemicals in food. A
1.9 1.9.13 Develop analytical method for polybrominated diphenyl ethers and initiate sampling in selected foods. B
1.9 1.9.14 Develop policy for ethyl carbamate in food. B
1.9 1.9.15 Develop an enhanced analytical method for methyl mercury. B
1.9 1.9.16 Develop draft guidance levels for methanol in alcoholic beverages. B
1.9 1.9.17 Develop draft lead action levels for foods based on levels adopted by Codex. B
1.9 1.9.18 Develop a revised action level for aflatoxin in peanuts. B
1.9 1.9.19 Develop draft action level for the mycotoxin, deoxynivalenol, in wheat products such as wheat flour. B

Transmissible Spongiform Encephalopathies (TSEs)
Strategy Sub Strategy Goal Description Priority Level
1.10 1.10.1 Publish final rule on Bovine Spongiform Encephalopathy (BSE) recordkeeping. A
1.10 1.10.2 Finalize Interim Final Rule for Bovine Spongiform Encephalopathy (BSE). A
1.10 1.10.3 Complete Bovine Spongiform Encephalopathy (BSE) risk assessment. A

Game Meat
Strategy Sub Strategy Goal Description Priority Level
1.11 1.11.1 Identify manufacturers or processors of game meats and game meat products and then develop an inspection and sampling plan to evaluate compliance with applicable laws. A

Food Allergens
Strategy Sub Strategy Goal Description Priority Level
1.12 1.12.1 Implement the provisions of the Food Allergen Labeling and Consumer Protection Act of 2004, including training, guidance and outreach activities to: 1) assist industry and 2) provide the appropriate information to FDA field staff.   A
1.12 1.12.2 Obtain expert consultation on gluten-free labeling in response to the Food Allergen Labeling and Consumer Protection Act of 2004. A
1.12 1.12.3 Develop for publication in FY 2006 a proposed rule for gluten-free labeling in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). A
1.12 1.12.4 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
1.12 1.12.5 Issue draft guidance on the use of test kits to detect the presence of peanut protein for regulatory purposes. A
1.12 1.12.6 Complete an Association of Official Analytical Chemists (AOAC) interlab study for immunochemical peanut protein test kits following the AOAC-harmonized validation protocol. A
1.12 1.12.7 Initiate Association of Official Analytical Chemists (AOAC) performance and harmonized validation of egg and milk test kits. A
1.12 1.12.8 Issue allergen Compliance Program and implement enforcement strategy. A
1.12 1.12.9 Issue report on allergen inspections. A
1.12 1.12.10 Develop a comprehensive food allergen strategy to address considerations such as cross-contamination problems. B

Dairy Safety
Strategy Sub Strategy Goal Description Priority Level
1.13 1.13.1 Complete the evaluation of the science of raw milk cheeses. (60 day aging). A
1.13 1.13.2 Issue revised draft dairy based Compliance Policy Guides (CPG) to reflect current practices and remove outdated CPGs. A
1.13 1.13.3 Issue final updated Federal Import Milk Act (FIMA) Compliance Policy Guide (CPG). A
1.13 1.13.4 Develop draft guidance on performance standards and validation of new technologies for pasteurization based on the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) advice. B
1.13 1.13.5 Evaluate the science and develop specific options for Vitamins A & D supplementation of dairy products.   B
1.13 1.13.6 In collaboration with FDA's Office of Regional Operations (ORO) and FDA's Center for Veterinary Medicine (CVM), validate the method to be used for the new National Drug Residue Milk compliance Program (NDRMCP). B
1.13 1.13.7 In conjunction with FDA's Center for Veterinary Medicine (CVM), develop a statistically-based comprehensive national plan for the monitoring of milk for the presence of animal drug residues. B
1.13 1.13.8 Validate the test kits commercially available for the detection of aflatoxin in milk. B

Education
Strategy Sub Strategy Goal Description Priority Level
1.14 1.14.1 Consolidate CFSAN consumer education and outreach activities to enhance efficiencies and coordination of public messages.   A
1.14 1.14.2 Carry out a consumer education campaign on the safe handling of produce.   A
1.14 1.14.3 Develop new and promote existing food label education materials particularly those pertaining to healthy weight management and healthy lifestyles. A
1.14 1.14.4 Prepare and distribute "Moms to Be" educational program for pregnant women to health care providers. A
1.14 1.14.5 Prepare and distribute "Moms to Be" educational program in Spanish. A
1.14 1.14.6 Carry out a multicultural food safety initiative educational program for pregnant women through Hispanic media and community-based public health specialists in high density Spanish-speaking areas on the risk of Listeria monocytogenes (Lm) in cheeses. A

Part II
Improving Nutrition and Dietary Supplement Safety

Contents

Nutrition, Health Claims and Labeling
Dietary Supplements


Priority Areas

Nutrition, Health Claims and Labeling
  Strategy Sub Strategy Goal Description Priority Level
2.1.1 Preventing Obesity through Better Nutrition

2.1 2.1.1 a.  Establish Obesity Working Group 2 (OWG2), chaired by the Director of CFSAN, to maintain the momentum of the Obesity Working Group (OWG) and to make sure the objectives in the "Calories Count" report are implemented and revised as necessary on related issues such as:.
  • Continuing involvement in Keystone Center-led national policy dialogue initiative to address aspects of the obesity problem.
  • Engaging and maintaining active dialogue on obesity issues with interested stakeholders.
A
2.1 2.1.1 b.  Publish proposed rule for carbohydrate nutrient content claims. A
2.1 2.1.1 c.  Publish an Advance Notice of Proposed Rulemaking (ANPRM) for the terms used in relation to carbohydrate content of foods, e.g., "net" and "effective." A
2.1 2.1.1 d.  Publish final rule on sodium provisions for the implied nutrient content claim "healthy." A
2.1 2.1.1 e.  Publish an Advance Notice of Proposed Rulemaking (ANPRM) to solicit public comment on how to give more prominence to calories on the food label, e.g., increasing the font size for calories, including a percent Daily Value (%DV) column for total calories, and eliminating the listing for calories from fat. A
2.1 2.1.1 f.  Publish an Advance Notice of Proposed Rulemaking (ANPRM) to solicit comment on (1) whether to require food packages that can reasonably be consumed at one eating occasion to declare the whole package as a single serving, (2) which, if any, Reference Amounts Customarily Consumed (RACCS) of food categories need to be updated, and (3) whether to provide for comparative claims for smaller portions of identical foods. A
2.1 2.1.1 g.  Publish draft guidance on the evidence-based ranking system for health claims and qualified health claims. A
2.1 2.1.1 h.  Publish an Advance Notice of Proposed Rulemaking (ANPRM) to solicit comments on updating Daily Values in nutrition labeling. A
2.1.2 Enhance Consumer Health Information for Better Nutrition 2.1 2.1.2 a.  Provide consumer studies research and economic data to help develop principles for use of the word "net" in relation to carbohydrate content. A
2.1 2.1.2 b.  Review comments on the Advance Notice of Proposed Rulemaking (ANPRM) and develop proposed rule to regulate qualified health claims. A
2.1 2.1.2 c.  Review comments received on the proposed rule providing for more flexibility in the use of health/nutrient content claims in response to citizens' petitions (Docket nos. 94P-0390 and 95P-0241). B
2.1 2.1.2 d.  Develop strategy to initiate rulemaking on claims for whole grains. B
2.1.3 Protecting and Promoting Public Health with Agency Initiated Actions 2.1 2.1.3 a.  Develop strategy to address claims and disclosure/footnote statements on trans fat based on comments to July 11, 2003 Advance Notice of Proposed Rulemaking (ANPRM). A
2.1 2.1.3 b.  Publish a proposed rule to amend 21 CFR 190.6 relative to description of new dietary ingredients. A
2.1 2.1.3 c.  Publish proposed rule to revise, as appropriate, existing regulation that requires irradiated food to be labeled. A
2.1.4 Improve Efficiency/Responsiveness 2.1 2.1.4 a.  Develop a final rule to update nutrient values for the voluntary nutrition labeling program. B
2.1 2.1.4 b.  Develop data collection instrument for the Food Label and Package Survey (FLAPS). B
2.1.5 Infant Formula and Medical Foods 2.1 2.1.5 Publish a final rule for infant formula Good Manufacturing Practice (GMP) and quality factors. A
Dietary Supplements
  Strategy Sub Strategy Goal Description Priority Level
2.2.1 Protecting and Promoting Public Health with Agency Initiated Actions 2.2 2.2.1 a.  Publish a final rule for dietary supplement Good Manufacturing Practice (GMP). A
2.2.2 Improve Efficiency/Responsiveness 2.2 2.2.2 a.  Hold a public meeting to address industry submissions of 75-day pre-notifications for new dietary ingredients. A
2.2 2.2.2 b.  Publish final rule on "per day" labeling for dietary supplements. A
2.2 2.2.2 c.  Develop strategy for the implementation of the Dietary Supplement Health and Education Act of 1994 (DSHEA). A

Part III
Ensuring Food/Color Additive and Cosmetic Safety

Contents

Food and Color Additives: Premarket Review
Cosmetics

Priority Areas


Food and Color Additives: Premarket Review
  Strategy Sub Strategy Goal Description Priority Level
3.1.1 Protecting and Promoting Public Health with Agency Initiated Actions

3.1 3.1.1 a.  Make available draft updated chemistry guidance for recycled plastics. A
3.1 3.1.1 b.  Issue final guidance concerning the early food safety evaluation of new plant proteins produced by bioengineered plants intended for food use that may be present in the food supply, but that have themselves not completed all regulatory steps for marketing. A
3.1 3.1.1 c.  Develop a proposed rule to adopt the specifications in the most recent edition of the Food Chemicals Codex as appropriate. B
3.1 3.1.1 d.  Develop a proposed rule to extend exclusion from Environmental Assessments to additional categories of Agency action on food and color additives. B
3.1 3.1.1 e.  Develop a final rule to amend 21 CFR 178.1010, as a result of the Food Quality Protection Act (FQPA), to accommodate partial transfer of this regulation to the Environmental Protection Agency (EPA). B
3.1 3.1.1 f.  Develop guidance for packaging used when irradiating foods. B
3.1.2 Improve Efficiency/Responsiveness 3.1 3.1.2 a.  Publish a draft Compliance Policy Guide (CPG) for chloropropanols. A
3.1 3.1.2 b.  Develop a final rule for the GRAS Notification Program. B
3.1 3.1.2 c.  Develop final guidance on the use of antibiotic resistance genes in bioengineered plant foods. B
3.1 3.1.2 d.  Develop E-guidance for the electronic submission of food and color additive petitions. B
3.1 3.1.2 e.  Develop E-guidance for the food contact substance notification program. B
Cosmetics
  Strategy Sub Strategy Goal Description Priority Level
3.2.1 Protecting and Promoting Public Health with Agency Initiated Actions 3.2 3.2.1 a.  Publish final Alpha Hydroxy Acids (AHA) guidance on labeling of AHA-containing products.  A
3.2 3.2.1 b.  Develop Color Additive Lakes Preliminary Regulatory Impact Analysis (PRIA) for public comment analysis of economic impact of proposed rule for permanently listing color additive lakes. B
3.2 3.2.1 c.  Develop Color Additive Lakes final rule permanently listing color additive lakes through FDA. B
3.2 3.2.1 d.  Support National Toxicology Program/National Center for Toxicological Research (NTP/NCTR) photocarcinogenicity testing of glycolic acid andsalicylic acid. B
3.2.2  Improve Efficiency/Responsiveness

3.2 3.2.2 a.  Develop a cosmetic labeling strategy for amending 21 CFR 701.3 (c)(2) concerning outdated sources for naming cosmetic ingredients.  A
3.2 3.2.2 b.  Develop Cosmetic Handbook for Industry as Level 1 and Level 2 guidance documents. B
3.2.3 Enforcement/Compliance

3.2 3.2.3 a.  Respond to citizen petition proposing that FDA take immediate action to cease the unlawful distribution of misbranded, adulterated, and unlabeled cosmetics (Docket No. 2004P-0266/CP 1). A
3.2 3.2.3 b.  Develop draft guidance pertaining to 21 CFR section 740.10 warnings for products formulated with ingredients that lack adequate safety substantiation. B
3.2 3.2.3 c.  Perform preliminary investigations in the development of test protocols to determine the safety of tattoo inks. B
3.2 3.2.3 d.  Develop a strategy for assessing potential public health concerns associated with tattoo inks. B
3.2 3.2.3 e.  Develop a plan to establish criteria for cosmetic claims, implement the Inter-Center agreement concerning cosmetic products making drug claims through review of labeling, and conduct regulatory follow-up. B
3.2 3.2.3 f.  Develop a proposed rule concerning the use of hormones such as progesterone and pregnenolone in cosmetic products. B
3.2 3.2.3 g.  In conjunction with the National Toxicology Program (NTP), develop a protocol to assess absorption of titanium dioxide utilizing nanotechnology. B
3.2 3.2.3 h.  Conduct a human exposure estimate for selected phthalates present in cosmetic products. B
3.2 3.2.3 i.  Conduct annual internal control review of Color Certification Program procedures. To meet this need, the districts are to collect survey (investigational) samples of certified colors (21 CFR parts 74 and 82) for subsequent analysis and verification by CFSAN's Office of Cosmetics and Colors Color Certification Program. B

Part IV
Ensuring Food Safety: Crosscutting Areas

Contents

Science Base
International
Internal Processes
Focused, Economic-based Regulations
Management Initiatives

Science Base
Strategy Sub Strategy Goal Description Priority Level
4.1 4.1.1 Pilot the development of core competencies for scientific and regulatory professionals in two CFSAN program offices. A
4.1 4.1.2 Administer a task order to Association of Official Analytical Chemists (AOAC) to conduct a "blue ribbon" scientific panel to recommend the "best practices" for the validation of microbiological methods. A
4.1 4.1.3 Prepare three risk profile documents: Hepatitis A virus, Norovirus, and Listeria monocytogenes in produce. A
4.1 4.1.4 Conduct a program review of research on dietary supplements and develop a strategic plan for research. A
4.1 4.1.5 Host a meeting of academic research institutions to discuss CFSAN research needs and potential mechanisms for enhancing the interaction of the Center with its academic partners. A
4.1 4.1.6 Collect consumer data on current infant feeding practices, in conjunction with the Centers for Disease Control and Prevention (CDC), FDA's Office of Women's Health, the National Institutes of Health (NIH), and the Health Resources and Services Administration (HRSA). A
4.1 4.1.7 Review social science research on connections between food labeling and weight management. A
4.1 4.1.8 Implement a food safety intervention strategy to track progress toward the attainment of the public health food safety goals. A
4.1 4.1.9 In conjunction with the CFSAN Adverse Events Reporting System (CAERS), work with partners and their studies (Slone Epidemiology Survey, Behavioral Risk Factor Study, and the National Emergency Injury Surveillance Study) to collect and analyze adverse event data obtained from these studies. A
4.1 4.1.10 Implement cross-center training program for new hires using a clinical and epidemiology training module based on real adverse event data analyses from FDA. A
4.1 4.1.11 Increase consumer knowledge by 40% for trans fat, by 10% for saturated fat, and by 10% for omega-3 fatty acids based on the completion of the Food Safety Survey in FY 2004 and 2007. A
4.1 4.1.12 Develop a white paper for the foods and food technology Critical Path Initiative. A
4.1 4.1.13 Improve CFSAN's workplanning process so that it includes incorporation of risk-based priorities, best practices, and development of a multi-factorial risk model for both domestic and import operations. A
4.1 4.1.14 Identify common factors and a system to assist CFSAN in prioritizing and choosing sites/systems for inspection, including the establishment of a process for conducting statistically based audits of areas not identified as high risk as a means to ensure that the Agency is targeting appropriate sites for inspection and compliance/enforcement activities A
4.1 4.1.15 Provide risk analysis training and education to CFSAN staff and managers. B
4.1 4.1.16 Expand the microbiological proficiency testing program in support of the Food Emergency Response Network (FERN) and the Laboratory Response Network (LRN). B
International
Strategy Sub Strategy Goal Description Priority Level
4.2 4.2.1 Coordinate the FDA review (scientific and technical analysis) of proposed foreign Sanitary and Phytosanitary (SPS) measures notified to World Trade Organization (WTO) under the SPS Agreement. A
4.2 4.2.2 In accordance with Association of Food and Drug Officials' (AFDO) charge for 2004-2005, chair working group composed of industry, states and federal agencies to:
  • Harmonize state export certificates
  • Encourage at least 80% of the states to develop export certificate websites
  • Test harmonized export certificates with other country governments
  • Request information on export certificate requirements of importing countries through FAS foreign agriculture posts
  • Complete work to enable U.S. export certificate website to go "live".
A
4.2 4.2.3 Collaborate with USDA to develop a combined database ("metadatabase") to include all U.S. federal international technical assistance activities, to be accessible to all participating federal agencies. A
4.2 4.2.4 Prepare final FDA report on comparability of North American and European shellfish programs. B

Internal Processes
Strategy Sub Strategy Goal Description Priority Level
4.3 4.3.1 Consolidate CFSAN rulewriting function within the Office of Regulations and Policy of the Center for Food Safety and Applied Nutrition. A
4.3 4.3.2 Institute an outreach program that will inform regulatory authorities and industry of the requirements of the Low Acid Canned Food/Acidified Food (LACF/AF) regulations. A
4.3 4.3.3 Establish a process by which CFSAN will set compliance priorities by conducting a series of annual assessments that identify the internal and external hazards a regulated firm faces (e.g., those hazards within versus outside of a firm's control; addressing risk estimate and characterization of the hazard(s); and determining the consequences to the public health as a result of agency action vs. inaction). A
4.3 4.3.4 Finalize the CFSAN evaluation procedure under the Agency's risk management umbrella targeting specific problem areas such as dietary supplements, sprouts and "for cause" firms, including firms with recall problems. A
4.3 4.3.5 Publish proposed rule/direct rule to revise 21 CFR 113.40 to permit use of alternative temperature-indicating devices, as well as mercury-in-glass thermometers. A
4.3 4.3.6 Modify selected CFSAN Compliance Programs, EIR formats and the IOM so that during domestic inspections investigators examine, report, and track counterfeit imported products, returns of imported products, rejected imported products, and complaint files concerning imported products. A

Focused, Economic-based Regulations
Strategy Sub Strategy Goal Description Priority Level
4.4 4.4.1 Publish proposed rule on general principles for standards of identity in collaboration with USDA. A
4.4 4.4.2 Publish proposed rule to amend definition of "milk" in cheese standards (21 CFR 133) to provide for use of fluid ultra-filtered milk. A
4.4 4.4.3 Publish an Advance Notice of Proposed Rulemaking (ANPRM) to seek comments on amending standards of identity for parmesan cheese (21 CFR 165) and frozen desserts (21 CFR 135). A
4.4 4.4.4 Develop proposed rule to amend the standard of identity for yogurt. B
Management Initiatives
Strategy Sub Strategy Goal Description Priority Level
4.5 4.5.1 Complete the FY 2005 zero based budget process which includes identifying priority funding needs and all essential costs associated with the foods program and continue an on-going review throughout the year.  A
4.5 4.5.2 Complete CFSAN's radioactive and chemical decommissioning efforts in Federal Building 8. A
4.5 4.5.3 Complete the occupancy of CFSAN's adjunct building: University Station, ensuring that all systems and laboratories are fully functional. A
4.5 4.5.4 Implement 1st year phase of the CFSAN Leadership Legacy Initiative across the Center. A
4.5 4.5.5 Provide training and other educational and developmental offerings to clerical and administrative support staff to prepare them for changes in work functions associated with the ongoing A-76 process. A

Part V
Priority Ongoing Activities

Food Defense: Emergency Preparedness

  1. Complete the annual food defense section of the FDA counterterrorism research report to Congress.
  2. Continue to conduct intramural and extramural research to determine threat agent characteristics in foods.
  3. Continue to conduct intramural and extramural research to determine threat agent dose response in humans.
  4. Continue to conduct intramural and extramural research to determine threat agent prevention strategies.
  5. Continue interagency microbial forensics research efforts with the Department of Homeland Security.
  6. Establish laboratory proficiency by providing testing samples to the Food Emergency Response Network (FERN) food testing laboratories to evaluate analyst proficiency in testing for biological agents of food defense and safety concern.
  7. Participate in emergency response exercises.
  8. Continue to support the establishment of Food Emergency Response Network (FERN) and enhance the interface between FDA and the Nationwide Laboratory Response Network (LRN) and utilize e-Lexnet for data exchange.

Food Safety/Outbreaks Response:

  1. Rapidly respond to emergency/outbreaks and issues and contact stakeholders as needed.
  2. Continue to utilize CDC PulseNet in outbreak investigations.

Domestic Inspections:

  1. In conjunction with ORA, inspect 95% of estimated 7,200 high-risk domestic establishments.
  2. Continue to evaluate results of "high-risk" plant and dairy food inspections. Make recommendations on whether the program is accomplishing its objective and identify where and how the program needs to be improved.

Foreign Inspections:

  1. In conjunction with ORA (contingent upon resources), conduct an estimated 255 foreign inspections.
  2. In conjunction with ORA, perform 60,000 physical exams and conduct sample analyses on products with suspect histories.
  3. In conjunction with ORA, complete the evaluation and classification of foreign firms inspections.

Seafood Safety:

  1. Continue to work with the ISSC to implement a control strategy for Vibrio vulnificus in raw oysters.
  2. Continue to revise as appropriate existing guidance on proper on-board handling of seafood to the fishing industry that harvests scombroid species, and provide ongoing educational programs for the seafood industry.
  3. Continue to evaluate seafood industry Hazard Assessment Critical Control Point (HACCP) performance.
  4. Continue to develop and maintain seafood case precedent system to capture those unique aspects of cases that amplify or clarify policy regarding hazards or controls.
  5. Implement the second year of a three year extramural research project on: (a) whether there are types of Modified Atmosphere Packaging (MAP) that are not likely to produce a hazard, depending upon how permeable they are to oxygen; and (b) whether there are qualities of the fish, e.g., fat content, that make a species more or less likely to form toxin in MAP.
  6. Continue to consolidate and array all data on chemical contaminants in seafood.
  7. Continue to review Fish Naming Criteria and update as necessary.

Fresh Fruits and Vegetables:

  1. Begin implementation of the Produce Safety Action Plan.
  2. Collect and analyze produce samples in collaboration with ORA.
  3. Work with relevant trade association s to develop GAPs and GMPs for selected commodities,such as tomatoes, cantaloupes, and green onions.
  4. Continue to conduct international Good Agricultural Practices (GAP) outreach in conjunction with the Joint Institute for Food Safety and Applied Nutrition (JIFSAN).

Listeria:

  1. Work with the states to reduce the production and sale of unlawful raw milk cheeses.

Cooperative Programs

  1. Continue to increase the adoption of the Food code within the U.S. and its Terroritories.
  2. Through the FDA National Steering Committees for Grade A Milk and Molluscan Shellfish, develop strategic goals for a risk-based focus for the benefit of the National Program and our regulatory partners.
  3. Maintain up-to-date science-based information in the Pasteurized Milk Ordinance through the efforts of the 2005 National Conference of Interstate Milk Shippers (NCIMS) and effect implementation of the provisions nationwide.
  4. Maintain up-to-date science-based information in the Interstate Sanitation Shellfish Conference (ISSC) Model Ordinance through the efforts of the ISSC Conferences and effect implementation of the provisions nationwide.

Chemical Contaminants, Pesticides and Other Hazards

  1. In conjunction with ORA, continue to analyze selected Total Diet Study samples and to collect and analyze selected samples for acrylamide.
  2. In conjunction with ORA, continue to collect and analyze 8,000 food samples for pesticides and chemical contaminants.
  3. Continue implementation of acrylamide action plan.
  4. Continue implementing FDA's dioxin and Polychlorinated Biphenyl (PCB) strategy, including monitoring, methods development, identifying opportunities to reduce exposure.
  5. Develop for the Internet the FDA Pesticide Monitoring data and summary information as required by the Pesticide Monitoring Improvement Act (PMIA).
  6. In conjunction with ORA, continue to collect and analyze samples of honey and seafood for the presence of chloramphenicol.

Food Allergens:

  1. Continue consumer and industry outreach for food allergens.
  2. Evaluate data from food allergen inspections.

Education:

  1. Continue to respond to consumer inquires via the hotline (1-888-SAFEFOOD).
  2. Continue education campaign for at-risk populations about methylmercury in fish and shellfish.
  3. Enhance consumer awareness about FDA food safety advice through media placements and exhibits.
  4. Continue to enhance consumer awareness about FDA food safety advice through Spanish language media placements.
  5. Continue to distribute food safety educational materials in Spanish at health fairs targeting major Hispanic populations.
  6. Continue to distribute brochures in Spanish on the safe handling of produce.

Preventing Obesity through Better Nutrition:

  1. Conduct additional research to develop "Calories Count" measures.

Enhance Consumer Health Information for Better Nutrition:

  1. Conduct enforcement activities related to violative labeling of conventional foods.

Infant Formula:

  1. Continue to review premarket notifications for new infant formulas within statutory timeframe.

Review of Health Claims:

  1. Continue to review nutrient content/health claim notifications and petitions within statutory timeframes.

Dietary Supplements:

  1. Continue to review premarket (75-day) notifications for new dietary ingredients within statutory timeframe.
  2. Continue to review 30-day postmarket notifications for supplement claims in a timely manner.
  3. Continue to develop educational materials that provide plain language information on dietary supplements to improve public understanding of these products.
  4. Continue to identify dietary supplement ingredients/products that raise safety problems, and take appropriate enforcement action.
  5. Continue efforts, in conjunction with the Federal Trade Commission, to take action against unsubstantiated claims on dietary supplements.

Food and Color Additives: Premarket Review

  1. Continue to review food and color additive petitions within the established time frame.
  2. Continue to review biotechnology final consultations within the established time frame.
  3. Continue to review GRAS notifications (GRNs) within the established time frame.
  4. Continue to review premarket notifications for food contact substances within the established time frame.
  5. Continue CFSAN Bio-research monitoring program (GLP inspections).
  6. Continue monitoring the use of bromates in baked goods. (formerly 3.1.2.h)
  7. Continue enforcement activity for dietary supplement type ingredients in conventional foods whose use is neither approved under section 409 nor generally recognized as safe.
  8. Continue applied research to develop analytical methodology for monitoring and enforcement of food additive regulations.
  9. Continue to develop and validate analytical methods for detecting and quantifying substances in dietary supplements and conventional foods.
  10. Continue to develop and expand The Food Additive Regulatory Management (FARM) System to provide external stakeholder access to the electronic submission process and to increase internal reviewer's access to data to expedite the review process.

Cosmetics

  1. Continue to analyze all batches of color additives and determine certification status (certify or refuse to certify) within an average of 5 working days.

Science Base

  1. The Human Subjects Protection Committee (HSPC) and the Research Involving Human Subjects Committee (RIHSC) Liaison Committee will continue oversight for all CFSAN investigators conducting research involving human subjects. HSPC and RIHSC Liaison standard operating procedures are currently in place and are being implemented by CFSAN.
  2. Continue to update and enhance the Bacteriological Analytical Manual (BAM), including validation of the BAM methods.
  3. Continue to collect and evaluate data for the annual Food Safety Survey.
  4. Provide training and educational offerings to increase the Center's emergency preparedness and enhance emergency response, particularly in the area of food defense: scientific and laboratory-based courses, emergency response exercises, emergency preparedness and continuity of operations, regulations and guidance.
  5. Continue to enhance and conduct training and education program for supervisors and team leaders.
  6. Continue to support, facilitate and coordinate the establishment and/or enhancement of academic partnerships including existing Centers of Excellence [National Center for Food Safety and Technology (NCFST), the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), the National Center for Natural Products Research (NCNPR)] and future partners.
  7. Continue to conduct research to develop new analytical methods or investigate know analytical methods for detecting and identifying microbial pathogens, chemical contaminants, and toxins in foods and cosmetics that can be potentially harmful to the public health.

International

  1. Continue FDA leadership in Codex. Ensure adequate participation in Codex committees, ad-hoc task forces, and working groups meeting in FY 2005 that are of relevance to FDA/CFSAN.
    • Codex Alimentarius Commission
    • General Principles (2 meetings
    • Food Hygiene
    • Food Additives and Contaminants
    • Food Import and Export Inspection and Certification Systems
    • Nutrition and Foods for Special Dietary Uses
    • Methods of Analysis and Sampling
    • Food Labeling
    • Pesticide Residues
    • North America and the Southwest Pacific
    • Fish and Fishery Products
    • Fats and Oils
    • Foods Derived from Modern Biotechnology (work comprises involvement to re-establish Task Force and determine new work items).
    • Juice and Juice Products
    • Milk and Milk Products
  2. Continue to represent FDA in U.S. Delegations to committees involved in implementing and interpreting existing trade agreements on sanitary and phytosanitary measures (e.g., World Trade Organization (WTO), Sanitary and Phytosanitary (SPS) Agreement, and Central American Free Trade Agreement (CAFTA), U.S./Chile SPS Agreement).
  3. Continue to represent FDA in multilateral and bilateral negotiations on the SPS sections of trade agreements (e.g., Andean countries, Thailand).
  4. Continue to notify World Trade Organization (WTO), Sanitary and Phytosanitary (SPS) and Technical Barriers to Trade (TBT) Committees, through U.S. contact points, of all FDA proposed rules affecting trade of food and cosmetics, in accordance with WTO obligations on transparency.
  5. Continue to issue Certificates for Export to U.S. food and cosmetic producers and exporters as necessary to satisfy the requests of foreign governments for U.S. attestation that the particular products are produced and marketed in the United States in general conformity with U.S. requirements.

Internal Processes

  1. Continue to provide mathematical and statistical support to high priority initiatives and regulations.
  2. Continue to review and revise the CFSAN Adverse Events Reporting Systems (CAERS) to better track adverse events for CFSAN-regulated products.
  3. Continue cooperative research agreement between CFSAN/FDA and University of Mississippi's National Center for Natural Products Research (NCNPR).
  4. Continue to conduct outreach activities to both internal FDA and external stakeholders to provide information access and training by maintaining, modifying, and/or expanding CFSAN's Office of Compliance intranet web site to further strengthen its usefulness as a primary source of assistance and information for field stakeholders operating on behalf of the Center for Food Safety and Applied Nutrition.
  5. Continue to expand Low Acid Canned Food (LACF) and Acidified Food (AF) web-based firm registration and process filing to the rest of domestic firms and initiate roll-out of the web-based system for foreign firms.
  6. Provide additional training to CFSAN staff and managers on protection of human subjects in research.
  7. Continue to enhance the Interstate Travel Program (ITP).
  8. Continue to issue Temporary Marketing Permits (TMP) for the interstate shipment of experimental packs of food varying from requirements of standards of identity, in accordance with 21 CFR 130.17.
  9. In conjunction with the FDA Office of Regulatory Affairs (ORA), continue to develop and deliver State and Federal (web based) curricula for:
    • Certification of Cooperative Programs Specialists and state and local regulators.
    • Low Acid Canned Foods (LACF) leveraging activities.
    • Listeria control implementation for manufacturers and retail/food service operators
    • Food Allergen control strategies.
    • National Conference on Interstate Milk Shipments (NCIMS) Grade "A" voluntary HACCP alternative to the traditional Grade "A" regulatory system for state regulatory agencies.

Management Initiatives

  1. Continue to develop and refine, in conjunction with FDA's Office of Regulatory Affairs (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.
  2. Continue implementation of initiatives associated with the President's Management Agenda within the 5 core areas identified in the Agenda.
  3. Continue to work with National Treasury Employees Union (NTEU) and the Cooperation Committee to fully implement the NTEU Collective Bargaining Agreement.
  4. Continue focus group research and interviews to support the CFSAN Leadership Legacy Training Program.
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