CFSAN 2004 Program Priorities

Letter from Center Director
Table of Contents

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Dear Colleague, FDA Foods Community

I am pleased to share with you the FY 2004 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 2004 (October 1, 2003 through September 30, 2004), and 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 and the overall public health?"   On behalf of CFSAN, I thank you for your input and your continuing interest in this process.

Our work plan is divided into four primary sections: 

1. Assuring Food Safety and Security
2. Improving Nutrition and Dietary Supplement Safety
3. Assuring Food and Cosmetic Safety
4. Assuring Food Safety: Crosscutting Areas

Last August, the Agency issued its Strategic Action Plan, Protecting and Advancing America's Health: Responding to new challenges and opportunities.   CFSAN's work plan embraces the FDA Strategic Action Plan and our work plan incorporates action items to implement those goals and objectives.

Food Safety and security remains a central theme in the Administration's public health agenda.  Our work plan is reflective of 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 also reflects a commitment to revitalize and bolster our nutrition program.  Helping consumers improve their nutrition is an increasingly urgent part of the FDA mission.  Our efforts will 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 working harder than ever to make sure the information consumers receive is scientifically valid and easily understood.

This is an ambitious and aggressive work plan.  Our plan includes 168 "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, 2004.  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 work plan does not address our many 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. 

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Table of Contents

1. I. Assuring Food Safety and Security

   • Food Safety Implementing Regulations and Guidance
   • Food Security: Emergency Preparedness
   • Domestic Inspections
   • Imports and Foreign Inspections
   • 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. Assuring Food and Cosmetic Safety

   • Food and Color Additives: Premarket Review
   • Cosmetics

4. IV. Assuring Food Safety: Crosscutting Areas

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

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Part I
Assuring Food Safety and Security

Priority Areas

Food Security/Food Safety Implementing Regulations and Guidance

	Strategy	Sub Strategy	Goal Description	Priority Level
Regulations	1.1	1.1.1	Develop 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	Develop a final rule for the establishment of prior notification requirements for all imported food shipments.	A
	1.1	1.1.3	Food Facility Registration Interim Final Rule:reopen the comment period for 30 days, on a limited set of issues, to ensure that those who comment on the interim final would have had the benefit of outreach and education efforts and experience with the systems, timeframes, and data elements o the registration program prior to publication of the Food Facility Registration Final Rule.	A
	1.1	1.1.4	Prior Notice of Imported Food Interim Final Rule:reopen the comment period for 30 days to ensure that those who comment on the interim final would have had the benefit of outreach and education efforts and experience with the systems, timeframes, and data elements of the prior notice system prior to publication of the Prior Notice Final Rule.	A
	1.1	1.1.5	Issue a final rule for the establishment and maintenance of records to identify immediate previous source and immediate subsequent recipient of foods.	A
	1.1	1.1.6	Issue a final rule for the establishment of administrative detention requirements.	A
	1.1	1.1.7	Issue a proposed rule on Serious Adverse Health Consequences.	A
	1.1	1.1.8	Conduct a satellite downlink and hold a series of domestic and international outreach meetings to provide information to our stakeholders about the two interim final rules and the implementation of the registration, prior notice provisions of the Bioterrorism Act of 2002.	A
	1.1	1.1.9	Issue Joint Food and Drug Administration (FDA) and Customs and Border Protection (CBP) Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes.	A
Guidance	1.1	1.1.10	To implement authorities under the Bioterrorism Act (P.L. 107-188) in effect as of July 2002, issue for public comment Small Entity Compliance Guide on Registration of Food Facilities.  NOA published 12/12/03.	A
	1.1	1.1.11	To implement authorities under the Bioterrorism Act (P.L. 107-188) in effect as of July 2002, issue for public comment Small Entity Compliance Guide on Prior Notice. NOA published 12/12/03.	A
	1.1	1.1.12	To implement authorities under the Bioterrorism Act (P.L. 107-188) in effect as of July 2002, issue for public comment Compliance Policy Guide Sec. 110.310 – Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. NOA published 12/15/03.	A
	1.1	1.1.13	To implement authorities under the Bioterrorism Act (P.L. 107-188) in effect as of July 2002, issue for public comment Guidance for Industry:  Questions and Answers on the Interim Final Rule on Prior Notice of Imported Foods.  NOA published 12/16/03.	A
	1.1	1.1.14	To implement authorities under the Bioterrorism Act (P.L. 107-188) in effect as of July 2002, issue Compliance Policy Guide Sec. 110.300-Registration of Food Facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.  NOA published 12/19/03.	A
	1.1	1.1.15	To implement authorities under the Bioterrorism Act (P.L. 107-188) in effect as of July 2002, issue Guidance on food safety and security for the retail food sector. NOA published 12/17/03.	A
	1.1	1.1.16	To implement authorities under the Bioterrorism Act (P.L. 107-188) in effect as of July 2002, issue security guidance for Cosmetics.  NOA published 12/17/03.	A
	1.1	1.1.17	To implement authorities under the Bioterrorism Act (P.L. 107-188) in effect as of July 2002, issue for public comment, industry and field staff guidance, as necessary.	A
	1.1	1.1.18	Develop and issue a Good Importer Practices (GIPs) draft guidance focusing on food importers to enhance compliance with new Bioterrorism regulations, relevant receiving, handling, or processing requirements, and data declaration for risk-based entry data processing by FDA systems.	B
IT Systems	1.1	1.1.19	Design and build, 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.	A

Food Security: Emergency Preparedness

	Strategy	Sub Strategy	Goal Description	Priority Level
Laboratory Preparedness	1.2	1.2.1	Provide support to the FDA Office of Regulatory Affairs in the establishment and operation of the Food Emergency Response Network, including the articulation of interim methods, the development and delivery of training modules, the establishment and integration of laboratory communication systems and protocols, the integration with agency crisis management procedures, establishment of methods validation systems, and the establishment of proficiency programs for microbiological, chemical, and radiological detection methods.  Enhance the preparedness of CFSAN laboratories that are part of the FERN and/or LRN.	A
	1.2	1.2.2	Conduct food threat assessment evaluations.	A
	1.2	1.2.3	Conduct intramural and extramural research to determine threat agent characteristics in foods and dose response for humans.	A
	1.2	1.2.4	Acquire and communicate to the appropriate sector leads scientific information needed to consider and implement options for establishing prevention measures or shields for food identified as a high security concern.	A
	1.2	1.2.5	Conduct intramural and extramural research on prevention strategies.	A
	1.2	1.2.6	Validate and develop methods for use in foods and prioritize according to FDA food threat assessment.	A
	1.2	1.2.7	Provide proficiency test samples during FY 2004 to FDA food testing laboratories to evaluate analyst proficiency in testing for organisms of food security and safety concern.	A
Response Capability	1.2	1.2.8	Participate in emergency response exercises.	A
	1.2	1.2.9	(FDA) Provide Emergency Response training in critical areas essential to CFSAN's reparation for and response to potential acts of terrorism against the food supply.	A
	1.2	1.2.10	(FDA) Provide training on the Bioterrorism Rules.	A
	1.2	1.2.11	Enhance coordination of food security andcounter-terrorism issues with federal, state, andlocal governments and other organizations, through full participation in the Interagency Food Working Group (IFWG) and sub groups.	A
Safety Upgrades	1.2	1.2.12	Initiate upgrade of NCFST to BSL3.	A
	1.2	1.2.13	As a counter-terrorism activity, continue build out of BSL3 facility at MOD I.	A

Domestic Inspections

Strategy	Sub Strategy	Goal Description	Priority Level
1.3	1.3.1	Inspect 95% of all domestic firms that produce "high-risk" foods.	A
1.3	1.3.2	Evaluate results of FY 2003 "high-risk" inspections. Make recommendations on improvements.	A

Imports and Foreign Inspections

Strategy	Sub Strategy	Goal Description	Priority Level
1.4	1.4.1	Perform 60,000 physical exams and conduct sample analyses on products with suspect histories.	A
1.4	1.4.2	Contingent upon resources, conduct 180 foreign inspections.	A
1.4	1.4.3	Complete the evaluation and classification of foreign firm inspections.	A
1.4	1.4.4	Publish a proposed rule to set standards for the use of private laboratories and for testing imported foods.	A

Seafood Safety

Strategy	Sub Strategy	Goal Description	Priority Level
1.5	1.5.1	Report to Congress on seafood HACCP temperature requirements for imported seafood products and any planned or ongoing FDA research projects on the effectiveness of new technologies to control hazards due to improper temperature.	A
1.5	1.5.2	Report to Congress on sampling frequency and violation rates for imported shrimp, and its efforts to ensure that any shrimp that test positive for chloramphenicol will not be subsequently consumed.	A
1.5	1.5.3	Develop a revised draft of the consumer advisory on methylmercury in commercial seafood based on the recommendations from the Food Advisory Committee.	A
1.5	1.5.4	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
1.5	1.5.5	Continue to work with the ISSC to implement a control strategy for Vibrio vulnificus in raw oysters.	A
1.5	1.5.6	Publish final Vibrio parahaemolyticus risk assessment.	A
1.5	1.5.7	Conclude the study of optimum seafood-based inspection frequency.	B
1.5	1.5.8	Prepare analysis of all data gathered to date world-wide on the good aquaculture practices project to determine their adequacy for the drafting of guidance.	B
1.5	1.5.9	Prepare final FDA report on comparability of North American and European shellfish programs.	B
1.5	1.5.10	Publish guidance on the use of common or usual names for fish in order to provide clarification on this subject and to consolidate information from various sources.	B
1.5	1.5.11	Continue project to improve existing guidance on proper on-board handling to the fishing industry that harvest scombroid species, and to educate industry.	B
1.5	1.5.12	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 to develop a certification program for cantaloupes intended for export to US.	A
1.6	1.6.2	Finalize the 1st edition of the Juice Hazards and Controls Guide.	A
1.6	1.6.3	Issue draft guidance for fresh cut produce.	A
1.6	1.6.4	Prepare final report on modernizing the food Good Manufacturing Practices (GMPs).	A
1.6	1.6.5	Solicit public input on how to modernize FDA's Food Current Good Manufacturing Practices cGMPs.	A
1.6	1.6.6	Conduct international Good Agricultural Practices (GAP) outreach in conjunction with the Joint Institute for Food Safety and Applied Nutrition (JIFSAN).	A
1.6	1.6.7	Develop strategy for addressing outbreaks caused by pathogens in produce.	A
1.6	1.6.8	Develop a more sensitive Salmonella detection methodology for cantaloupe.	B
1.6	1.6.9	Issue final guidance for fresh cut produce.	B
1.6	1.6.10	Work with relevant trade associations to develop GAPs and GMPs for cantaloupes.	B
1.6	1.6.11	Publish report of the 1999 and 2000 sprout assignment.	B
1.6	1.6.12	Provide assistance to the California Department of Health Services on production of the video on safe juice processing.	B
1.6	1.6.13	Amend sprouts guidance regarding mung bean irrigation water sampling and use of kits.	B
1.6	1.6.14	Issue assignment to sample imported mung beans.	B
1.6	1.6.15	Work with APHIS and mango producers to ensure safe handling of mangoes.	B

Egg Safety Action Plan

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	Publish proposal to permit "in-lid" labeling for the Safe Handling Statement on shell eggs.	A
1.7	1.7.3	Hold public meetings on the proposed egg safety rule once it is issued.	B
1.7	1.7.4	In collaboration with the Office of Crisis Management (OCM), develop a draft Salmonella Enteritidis (SE) Traceback Investigation Protocol.	B

Listeria

Strategy	Sub Strategy	Goal Description	Priority Level
1.8	1.8.1	Publish for comment citizen petition to amend 21 CFR Part 109 to establish a regulatory limit for Listeria monocytogenes in foods that do not support its growth.	A
1.8	1.8.2	Submit to Congress a copy of the report from 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, when the report becomes available in 2004.	B
1.8	1.8.3	Issue draft guidance advising processors on steps to reduce Listeria monocytogenes contamination in ready-to-eat foods.	B
1.8	1.8.4	Issue a field assignment regarding "gourmet" raw milk soft cheeses.	B
1.8	1.8.5	Develop Listeria guidance specifically for the dairy industry.	B
1.8	1.8.6	Perform targeted inspections of dairy products manufactures with an emphasis on those that produce pasteurized and raw milks, creams, butters and margarines, soft unripened cheeses and fresh soft cheeses.	B
1.8	1.8.7	Develop an action plan to address the unlawful importation of cheeses.	B
1.8	1.8.8	Work with the states to eliminate the production and sale of unlawful raw milk cheeses.	B
1.8	1.8.9	Operate a pilot program involving the smoked fish industry to determine the effectiveness and feasibility of implementing Listeria control strategies within smoked fish processing operations.	B

Cooperative Programs

1.9	1.9.1	In conjunction with CFSAN's Office of Compliance and FDA/ORA, achieve adoption of the Food Code in 43 states representing 83% of US population.	A
1.9	1.9.2	Increase the number of state and local Retail Food Regulatory Programs that are utilizing risk-based inspection programs by 50%, as measured by the Voluntary National Retail Food Regulatory Program Standards.	A
1.9	1.9.3	Work with stakeholders to institute a process to develop and present training for States to implement the NCIMS Grade "A" voluntary HACCP alternative to the traditional Grade "A" regulatory system.	B
1.9	1.9.4	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
1.9	1.9.5	Develop operational plans for the National Milk Safety Team and the National Shellfish Safety Team that identifies strategic goals and performance measures for the Teams.	B
1.9	1.9.6	Increase uniformity in regulations governing the retail segment of the food industry by: increasing the number of jurisdictions enrolled in the Voluntary Program Standards from 120 in FY 2003 to 180.	B
1.9	1.9.7	Develop strategic plan/best model for administering the Interstate Travel Program and infrastructure to implement.	B

Chemical Contaminants, Pesticides and Other Hazards

Strategy	Sub Strategy	Goal Description	Priority Level
1.10	1.10.1	Continue to analyze selected Total Diet Survey samples and to collect and analyze selected samples for acrylamide.	A
1.10	1.10.2	Issue final Compliance Policy Guide on radionuclides in foods to update existing levels and to add radionuclides.	A
1.10	1.10.3	Collect and analyze 8,000 food samples to maintain current level of monitoring for pesticides and chemical contaminants.	A
1.10	1.10.4	Continue implementing FDA's strategy, on dioxin-like compounds, including monitoring, method development and identifying opportunities to reduce exposure.	A
1.10	1.10.5	Issue a proposal to revise the bottled water quality standards for arsenic.	A
1.10	1.10.6	Complete analytical method development for detection of Perchlorate in selected products.	A
1.10	1.10.7	Perchlorate: conduct exploratory survey of foods particularly from areas where water sources are believed to be contaminated with Perchlorate.	A
1.10	1.10.8	Continue to collect and analyze samples of honey and seafood for the presence of chloramphenicol.	A
1.10	1.10.9	Issue communication on lead levels in candy.	A
1.10	1.10.10	Issue assignment to monitor lead in imported candy.	A
1.10	1.10.11	Develop analytical method for polybrominated diphenyl ethers in selected foods.	B
1.10	1.10.12	Update the pesticides CPG to bring it in line with FQPA.	B
1.10	1.10.13	Develop policy for ethyl carbamate in food.	B
1.10	1.10.14	Develop for the Internet the FDA Pesticide Monitoring data and summary information as required by the Pesticide Monitoring Improvement Act.	B
1.10	1.10.15	Unify clostridium botulinum policy for the wide variety of foods regulated by FDA.	B
1.10	1.10.16	Issue draft guidance levels for methanol in alcoholic beverages.	B
1.10	1.10.17	Issue draft lead action levels for foods based on levels adopted by Codex.	B
1.10	1.10.18	Revise action level for aflatoxin in peanuts.	B
1.10	1.10.19	Conduct workshop on exposure assessment methodologies and practices in support of the WHO/FAO project to update the principles of risk assessment for chemicals in food.	B
1.10	1.10.20	Issue final generic "channels of trade" guidance.	B

Transmissible Spongiform Encephalopathies (TSEs)

Strategy	Sub Strategy	Goal Description	Priority Level
1.11	1.11.1	Publish BSE regulation, paralleling USDA's regulation, banning use of bovine specified risk materials, nonambulatory disabled and dead cattle, and mechanically separated (beef) in CFSAN-regulated products.	A
1.11	1.11.2	Initiate a BSE risk assessment.	A
1.11	1.11.3	Determine potential of CWD infected cervids as a human health risk through collaboration with IFT/Harvard.	B

Game Meat

Strategy	Sub Strategy	Goal Description	Priority Level
1.12	1.12.1	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 Chemist (AOAC) interlab study for immunochemical peanut protein test kits following the AOAC harmonized validation protocol.	A
1.13	1.13.3	Issue draft guidance to the field on the use of test kits to detect the presence of peanut protein.	A
1.13	1.13.4	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
1.13	1.13.5	Develop proposed rule for the labeling of the most common allergens.	B
1.13	1.13.6	Develop a "Basic Food Allergen" training module (computerized) for ORA University to enhance and improve the Agency's knowledge base.	B
1.13	1.13.7	Develop a comprehensive food allergen strategy to address considerations such as cross-contamination problems (not including bioengineered foods).	B

Dairy Safety

Strategy	Sub Strategy	Goal Description	Priority Level
1.14	1.14.1	Publish draft updated Federal Import Milk Act (FIMA) Compliance Policy Guide.	A
1.14	1.14.2	Complete the evaluation of the science and safety of raw milk cheeses (60-day aging).	B
1.14	1.14.3	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	1.14.4	Evaluate the science and specific options for Vitamins A & D supplementation of Grade A dairy products.	B
1.14	1.14.5	Develop guidance for the pasteurization alternatives of section 403(h)(3) [Farm Security and Rural Investment Act of 2002].	B
1.14	1.14.6	Revise dairy-based CPGs to reflect current practices and remove outdated CPGs.	B
1.14	1.14.7	Continue to work toward completion of equivalence determinations with the EU.	B

Education

Strategy	Sub Strategy	Goal Description	Priority Level
1.15	1.15.1	Develop training manual for health educators to teach food safety to pregnant women and women who may become pregnant, in particular safe food handling and education about the risks of methyl mercury in seafood and Listeria monocytogenes in refrigerated foods.	A
1.15	1.15.2	Develop and distribute Seafood Safety Education Materials.	A
1.15	1.15.3	In conjunction with Radio Unica, provide an education and outreach program on food safety to the Hispanic community through participation in the Radio Unica Health Fair Initiative.	A
1.15	1.15.4	Complete a review of the preventive controls that industry may take to reduce the risk for an intentional act of terrorism or contamination using the US food supply for high risk and medium risk food commodity/agent combinations.	A
1.15	1.15.5	Conduct a Food Advisory Committee meeting to present an update on how FDA has responded to their July 2002 recommendations for revising the methylmercury advisory.	A
1.15	1.15.6	Develop the Food Safety and Security Health Professionals Program.	A

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Part II
Improving Nutrition and Dietary Supplement Safety

Priority Area

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 Agency-wide Obesity Working Group (OWG) chaired by the FDA Deputy Commissioner and vice-chaired by CFSAN Director, to address obesity through development of new and innovative ways to help consumers lead healthier lives through better nutrition.	A
		2.1	2.1.1	b.  Issue report within six months to the Commissioner outlining strategy for developing and implementing goals of the working group.	A
		2.1	2.1.1	c.  Obesity Message: Develop and begin testing consumer messages tied to "calories count" focus.	A
	Food Labeling	2.1	2.1.1	d.  Publish a Advance Notice of Proposed Rulemaking to solicit public comment on how to give more prominence to calories on the food label, i.e., 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	e.  Publish a Advance Notice of Proposed Rulemaking 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	f.  Develop principles for use of the term "net" in relation to the carbohydrate content of foods.	B
		2.1	2.1.1	g.  Develop an Advance Notice of Proposed Rulemaking to solicit comments on whether to allow a health claim such as "Diets low in calories may reduce the risk of obesity, which is associated with diabetes, heart disease, and certain cancers" on certain foods that meet FDA's definition of "reduced" or "low" calorie.	B
	Enforcement	2.1	2.1.1	h.  FTC/FDA: in conjunction with the Federal Trade Commission (FTC), increase enforcement against weight loss products having false or misleading claims.	A
		2.1	2.1.1	i.  Issue letter to manufacturers regarding inaccurate serving sizes and, as appropriate, issue letters concerning specific products.	A
	Restaurants	2.1	2.1.1	j.  Participate with the Office of the Commissioner in working with a third-party facilitator to develop options for providing voluntary standardized, simple and understandable nutrition (including calorie) information at point-of purchase in a restaurant setting; enlist restaurants to participate in pilot program to use options developed and evaluate program results at appropriate intervals.	A
	Education	2.1	2.1.1	k.  Participate with the Office of the Commissioner in working with a third-party facilitator to develop approaches including partnerships for educating consumers, particularly adolescents, about obesity.	A
2.1.2 Enhance Consumer Health Information for Better Nutrition		2.1	2.1.2	a.  Publish ANPRM to request comment on the regulatory strategy for qualified health claims.	A
		2.1	2.1.2	b.  Conduct and analyze consumer research to help ensure that qualified health claim messages in the labeling of foods and dietary supplements employ the most effective wording so that the messages are not misleading to consumers.	A
		2.1	2.1.2	c.  Publish proposed rule to regulate qualified health claims.	A
		2.1	2.1.2	d.  Reopen comment period on the proposed rule providing for more flexibility in the use of health/nutrient content claims in response to citizens' petitions (Docket nos. 4P-0390 and 95P-0241).	A
2.1.3 Review of Industry Submissions/Statutory Requirements		2.1	2.1.3	a.  Review nutrient content/ health claim notifications and petitions within statutory timeframe.	A
		2.1	2.1.3	b.  Review premarket notifications for new infant formulas within statutory timeframe.	A
		2.1	2.1.3	c.  Develop a final rule for infant formula GMPs and quality factors.	B
		2.1	2.1.3	d.  Develop proposed rule to revise, as appropriate, existing regulation that requires irradiated food to be labeled.	B
2.1.4 Protecting and Promoting Public Health with Agency Initiated Actions		2.1	2.1.4	a.  Promote trans fat education and outreach.	A
		2.1	2.1.4	b.  Extend for 60 days the comment period for the advance notice of proposed rulemaking for the Trans Fatty Acids in Nutrition Labeling.	A
		2.1	2.1.4	c.  Develop final rule on sodium provisions for the implied nutrient content claim "healthy."	B
		2.1	2.1.4	d.  Develop strategy to address claims and disclosure/footnote statements on trans fat based on comments to July 11, 2003, ANPRM.	B
		2.1	2.1.4	e.  Integrate data on caffeine content of conventional foods and dietary supplements to estimate total exposure and develop a policy on caffeine labeling.	B
2.1.5 Improve Efficiency/Responsiveness		2.1	2.1.5	a.  Develop proposed rule for nutrient content claims that are the subject of health claims.	B
		2.1	2.1.5	b.  Review the Institute of Medicine/National Academy of Sciences (IOM/NAS) report on methodology to be used to update reference values used in nutrition labeling and principles for discretionary fortification of foods based on new Dietary Reference Intake values and develop strategy for updating Daily Values in nutrition labeling.	B
		2.1	2.1.5	c.  Develop final rule to update nutrient values for the voluntary nutrition labeling program.	B
2.1.6 Enforcement/Compliance		2.1	2.1.6	a.  Conduct enforcement activities related to inappropriate labeling of conventional foods.	A

Dietary Supplements

	Strategy	Sub Strategy	Goal Description	Priority Level
2.2.1 Requirements Statutory/Congressional Requirements	2.2	2.2.1	a.  Review premarket (75-day) notifications for new dietary ingredients within statutory timeframe.	A
	2.2	2.2.1	b.  Review 30-day postmarket notifications for supplement claims in a timely manner.	A
	2.2	2.2.1	c.  Develop proposal to amend 21 CFR 190.6 relative to description of new dietary ingredients.	B
2.2.2 Protecting and Promoting Public Health with Agency Initiated Actions	2.2	2.2.2	a.  Publish a final rule for dietary supplement GMPs.	A
	2.2	2.2.2	b.  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
	2.2	2.2.2	c.  Continue to develop mechanisms to enhance timely clinical assessment of dietary supplement adverse event investigations.	B
2.2.3 Improve Efficiency/Responsiveness	2.2	2.2.3	a.  Develop guidance for industry on submissions of 75-day pre-notifications for new dietary ingredients.	A
	2.2	2.2.3	b.  Publish guidance on substantiation of structure/ function claims for dietary supplements.	A
	2.2	2.2.3	c.  Publish a final rule declaring dietary supplements containing ephedrine alkaloids adulterated under the FD&C Act.	A
	2.2	2.2.3	d.  Complete Dietary Supplement Labeling Guide and post on the CFSAN Web site.	B
	2.2	2.2.3	e.  Publish final rule on "per day" labeling for dietary supplements.	B
2.2.4 Enforcement/Compliance	2.2	2.2.4	a.  Continue to identify dietary supplement ingredients/products that raise safety problems, and take appropriate enforcement actions.	A
	2.2	2.2.4	b.  Continue efforts in conjunction with the Federal Trade Commission, to take action against unsubstantiated claims on dietary supplements.	A
	2.2	2.2.4	c.  Conduct surveillance activities pertaining to pesticides/contaminants in dietary supplement products.	B

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Part III
Assuring Food & Cosmetic Safety
General

Priority Area

Food and Color Additives: Premarket Review

	Strategy	Sub Strategy	Goal Description	Priority Level
3.1.1 Review of Industry Submissions/Statutory Requirements	3.1	3.1.1	a.  For the petition receipt cohort of FY 2003, complete within 360 days of filing, the safety evaluation of at least two of three of those food and color additive petitions that qualify for expedited review.	A
	3.1	3.1.1	b.  For the petition receipt cohort of FY 2003, 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
	3.1	3.1.1	c.  Complete CFSAN evaluation of biotechnology final consultations within 180 days.	A
	3.1	3.1.1	d.  Complete processing of 80% of GRAS notifications (GRNs) within 180 days.	A
	3.1	3.1.1	e.  Complete review of premarket notifications for food contact substances within the statutory time limit (120 days).	A
3.1.2 Protecting and Promoting Public Health with Agency Initiated Actions	3.1	3.1.2	a.  Increase enforcement actions for dietary supplement type ingredients in conventional foods whose use is neither approved under section 409 nor generally recognized as safe.	A
	3.1	3.1.2	b.  Develop documents to adopt the specifications in the most recent edition of the Food Chemicals Codex into regulations as appropriate.	B
	3.1	3.1.2	c.  Make available updated chemistry guidance for recycled plastics.	B
	3.1	3.1.2	d.  Continue to interact with stakeholders proactively by encouraging prefiling consultations for new submissions.	A
	3.1	3.1.2	e.  Develop a Federal Register proposal extending exclusion from Environmental Assessments to additional categories of Agency action on food and color additives.	B
	3.1	3.1.2	f.  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
	3.1	3.1.2	g.  Develop guidance for packaging used when irradiating foods.	B
	3.1	3.1.2	h.  Continue to monitor the use of bromates in baked goods.	B
	3.1	3.1.2	i.  Continue to make additional final revised Redbook Chapters available on the FDA website.	B
3.1.3 Improve Efficiency/Responsiveness	3.1	3.1.3	a.  Make publicly available 5 study review templates on the Internet to facilitate the evaluation of toxicology/safety data submitted in food and color additive petitions and in food contact notifications.	A
	3.1	3.1.3	b.  Develop guidance for the electronic submission of food and color additive petitions.	B
	3.1	3.1.3	c.  Develop E-guidance document for the food contact substance notification program.	B
	3.1	3.1.3	d.  Develop a final rule for the GRAS notice program.	B
	3.1	3.1.3	e.  Develop E-guidance document that would accompany the GRAS notification program final rule.	B
3.1.4 Enforcement/Compliance	3.1	3.1.4	Publish a draft Compliance Policy Guide (CPG) for chloropropanols.	A

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.  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
	3.2	3.2.1	b.  Alpha Hydroxy Acids (AHA): Publish final guidance on labeling of AHA containing products.	A
	3.2	3.2.1	c.  Color Additive Lakes (PRIA): Publish, for public comment, analysis of economic impact of proposed rule.	B
	3.2	3.2.1	d.  Color Additive Lakes:  Develop a final rule permanently listing color additive lakes through FDA.	B
	3.2	3.2.1	e.  Cosmetic Product Safety:  Support NTP/NCTR photocarcinogenicity testing of glycolic acid and salicylic acid.	B
3.2.2  Congressional Reports/Directives	3.2	3.2.2	Report to Congress on steps that will be taken to ensure that there will not be any future excessive fluctuations in the cost of the color certification program.	A
3.2.3 Improve Efficiency/Responsiveness	3.2	3.2.3	a.  Develop electronic tracking and filing system, Oracle based, to improve workflow, document tracking, and ease sharing of documents and information with the Office of Cosmetics and Colors.	A
	3.2	3.2.3	b.  Cosmetic Labeling: Develop a strategy for amending 701.3 (c)(2) to update sources for naming cosmetic ingredients.	A
	3.2	3.2.3	c.  Develop Cosmetic Handbook for Industry as Level 1 and Level 2 guidance documents.	B
3.2.4 Enforcement/Compliance	3.2	3.2.4	a.  Develop an analytical method for the determination of phthalates in cosmetic products.	A
	3.2	3.2.4	b.  Conduct a survey of products to determine the contribution of phthalates to human exposure.	A
	3.2	3.2.4	c.  Sampling survey: Conduct annual internal control review of its procedures for the Color Certification Program.  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 OCAC's Color Certification Program.	B
	3.2	3.2.4	d.  Develop draft guidance for issuance of 21 CFR section 740.10 warnings for products formulated with ingredients that lack adequate safety substantiation.	B
	3.2	3.2.4	e.  Tattoo inks: Perform preliminary investigations in the development of test protocols to determine the safety of tattoo inks. Develop a strategy for assessing potential public health concerns associated with tattoo inks.	B
	3.2	3.2.4	f.  Guidance for Cosmetic Labeling: 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	3.2.4	g.  Re-propose use of progesterone and pregnenolone in cosmetics to evaluate claims and quantities of hormones allowable in cosmetic products.	B
	3.2	3.2.4	h.  Nanotechnology: In conjunction with the NTP, develop a protocol to assess absorption of titanium dioxide.	B

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Part IV
Assuring Food Safety: Crosscutting Areas

Priority Area

Science Base

Strategy	Sub Strategy	Goal Description	Priority Level
4.1	4.1.1	Evaluate foodborne illness risk factors in conjunction with the FDA National Retail Food Team to establish public health food safety goals (Food Safety Program Assessment Rating Tool Goal), and track progress toward those goals.	A
4.1	4.1.2	Provide training on methods of risk analysis for foods.	A
4.1	4.1.3	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.	A
4.1	4.1.4	Re-engineer the CFSAN Laboratory Quality Assurance System.	A
4.1	4.1.5	Continue the cooperative research agreement between CFSAN/FDA and the University of Mississippi's National Natural Products Research Center.	A
4.1	4.1.6	Enhance CFSAN's science base and interaction with the academic community through "Centers of Excellence" - host a meeting to present research needs and coordinate activities amongst the existing Center of Excellence (NCFST, JIFSAN, NCNPR) and other academic counterparts and stakeholder groups.	A
4.1	4.1.7	Plan the FY-05 Food Safety Survey.	A
4.1	4.1.8	Conduct a Program Effectiveness Conference in conjunction with CDC and a brief report to evaluate mechanisms and methods to measure the degree of food related risks.	A
4.1	4.1.9	Conduct survey data on consumer understanding of the relationships between heart disease risk and consumption of trans, saturated and omega 3 fatty acids to provide a baseline for measuring long-term changes in consumer understanding.	A
4.1	4.1.10	Establish leveraging activities with the Department of Homeland Security to develop methods for strain attribution of foodborne pathogens.	A
4.1	4.1.11	Collect consumer data on current Infant Feeding Practices and, in conjunction with CDC, FDA's Office of Women's Health, NIH, and HRSA, evaluate HHS Breastfeeding Awareness Campaign. (FY 04-05)	B
4.1	4.1.2	Develop clinical and epidemiology training modules based on real adverse event data analyses from FDA work for new hires.	B
4.1	4.1.13	Implement 1st phase of the Learning Management System.	B
4.1	4.1.14	Coordinate CFSAN Leadership Training Program.	B
4.1	4.1.15	Implement key recommendations of CFSAN's assessment of the JIFSAN Program.	B

International

Strategy	Sub Strategy	Goal Description		Priority Level
4.2	4.2.1	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 Session:	1.  Codex Commission Alimentarius Commission	A
		Cross-cutting General Subject Committees:	2.  Nutrition and Foods for Special Dietary Uses	A
			3.  Food Import and Export Inspections and Certifications Systems	A
			4.  Food Hygiene	A
			5.  Methods of Analysis and Sampling	A
			6.  Fish and Fishery Products	A
			7.  Food Additives and Contaminants	A
			8.  General Principles (19th Session)	A
			9.  Food Labeling	A
			10.   Milk and Milk Products	A
			11.  General Principles (20th Session)	A
		Trilateral U.S./Canada/Mexican Activities:	12.  Technical Working Group for Food Labeling, Packaging and Standards.	A
4.2	4.2.2	Participate in United States trade negotiations to draft the sanitary and phytosanitary articles of the agriculture chapters of the Central American Free Trade Agreement (CAFTA), Morocco, Andean Community, Australia, Bahrain, Dominican Republic, Panama, Southern African Customs Union (SACU, Sri Lanka, and Thailand FTAs  to ensure public health protections are maintained and FDA's regulatory authority not compromised in  each FTA.  Includes working on SPS trade-related issues of products under FDA jurisdiction.		A
4.2	4.2.3	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
4.2	4.2.4	Move OCO databases of Technical Assistance Events/People and International Travel into CFSAN shared files to provide search access to CFSAN staff.		B
4.2	4.2.5	Develop FDA descriptors for the State/Federal Food Export Certificates Website.		B
4.2	4.2.6	Improve the safety of food, drug and cosmetic imports through the development of international harmonized standards, participation in the development and implementation of trade agreements, and provision of effective international technical assistance.		B
4.2	4.2.7	Participate in United States trade negotiations to draft the sanitary and phytosanitary articles of agriculture chapter in the Free Trade Area of the Americas (FTAA) to ensure the American consumer's public health remains protected and FDA's regulatory authority not compromised in the final FTAA.  The FTAA of 34 countries spanning the entire Western Hemisphere is projected to be completed by the end of 2005.		B

Food Biotechnology

Strategy	Sub Strategy	Goal Description	Priority Level
4.3	4.3.1	Enhance the information provided to the public in FDA's evaluation of foods derived from bioengineered plants.	A
4.3	4.3.2	Convene a public meeting of the food Biotechnology Subcommittee of the Food Advisory Committee to discuss current Agency activities in food biotechnology.	A
4.3	4.3.3	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
4.3	4.3.4	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.	B
4.3	4.3.5	Publish final guidance for voluntary labeling of foods that have or have not been developed using bioengineering.	B
4.3	4.3.6	Develop draft guidance on assessing allergenicity in relation to bioengineered food.	B
4.3	4.3.7	Develop guidance on the use of antibiotic resistance genes in bioengineered plant foods.	B

Internal Processes

Strategy	Sub Strategy	Goal Description	Priority Level
4.4	4.4.1	CFSAN Adverse Events Reporting System CAERS): Implement CAERS enhancements to improve tracking of dietary supplements and food and cosmetics adverse events.	A
4.4	4.4.2	Identify a partner or data source to obtain exposure and other missing data on OTC drugs, dietary supplements, and devices used at home.	A
4.4	4.4.3	Provide timely customer service, information and regulatory support to ORA field offices, including expanding this effort through the Office of Compliance's intranet site.	A
4.4	4.4.4	Governmentwide Paperwork Elimination Act (GPEA): Implement electronic submission and e-signature capability via the internet to meet GPEA requirements to allow for industry submission of Low Acid Canned Foods.	A
4.4	4.4.5	Work planning: Implement CFSAN's risk management framework which includes incorporation of risk based priorities, best practices, and development of a multi-factorial risk model for both domestic and import operations.	A
4.4	4.4.6	Inspections: 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
4.4	4.4.7	Compliance/Enforcement: 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 within versus outside of a firm's control); addressing risk estimate and characterization of the hazards); and determining the consequences to the public health as a result of Agency action vs. inaction.	A
4.4	4.4.8	Establish policies and procedures that enhance the use of a tiered approach to foreign food inspections based upon risk for foods so that the amount/type of oversight (e.g., full inspections, abbreviated or focused inspections, evaluations of GMP documents, etc.) is proportional to the degree of risk.  Process should be designed to promote development and maintenance of a flexible and risk-based stratified list of foreign facilities requiring inspection to maximize efficient use of foreign inspection resources.	A
4.4	4.4.9	Begin to modify CFSAN Compliance Programs, EIR foremast and the IOM so that during domestic inspections inspectors examine, report, and track counterfeit imported products, returns of imported products, rejected imported products, and complaint files concerning imported products.	A
4.4	4.4.10	Evaluate FY 2002 and FY 2003 review times by CFSAN staff on legal action reviews and recommend actions for CFSAN implementation to improve efficiency and effectiveness for meeting Agency time frames.	B
4.4	4.4.11	Implement the enhanced Center's correspondence control process that was developed in FY 2003 to improve the internal coordination of information to ensure orderly, timely, and coordinated responses to internal and external communications.	B
4.4	4.4.12	CFSAN will report to Congress any modifications, on any proposed consolidation efforts to CAERS with detail information on the impact to the system prior to these modifications being made.	B

Economic based Regulations

Strategy	Sub Strategy	Goal Description	Priority Level
4.5	4.5.1	Submit a report to Congress within 120 days of the close of the comment period of the ANPRM on standard of identity for Yogurt.	A
4.5	4.5.2	Report to Congress, quarterly, on the status of petitions regarding the use of ultrafiltered milk, casein, or milk protein concentrates in standardized dairy products.	A
4.5	4.5.3	Publish proposed rule on general principles for standards of identity in collaboration with USDA.	A
4.5	4.5.4	Develop proposed rule to amend definition for "milk" in cheese standards to provide for use of fluid ultra-filtered milk.	B
4.5	4.5.5	Develop advance notices of proposed rulemakings to seek comments on amending standards of identity for parmesan cheese and frozen desserts.	B
4.5	4.5.6	Develop response to petition requesting a common or usual name for soymilk.	B

EEO/Diversity Initiatives

Strategy	Sub Strategy	Goal Description	Priority Level
4.6	4.6.1	"Affirmative Employment Program":  Implement 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

 Management  Initiatives

Strategy	Sub Strategy	Goal Description	Priority Level
4.7	4.7.1	Complete the FY 2004 budget review, identifying priority funding needs and all essential costs associated with the foods program and continue an on-going review throughout the year.	A
4.7	4.7.2	Continue CFSAN's radioactive and chemical decommissioning efforts in Federal Building 8.	A
4.7	4.7.3	Manage and plan the occupancy of CFSAN's adjunct building: University Station.	A
4.7	4.7.4	Realign CFSAN's Office of Management Systems' Organizational structure and functions to reflect the establishment of an FDA Office of Shared Services.	A
4.7	4.7.5	Establish service level agreements and new modalities for working with the Office of Shared Services to establish and deliver the best possible service to the CFSAN User community.	A
4.7	4.7.6	Continue to develop and implement programs and policies to ensure full security over select agents used within CFSAN.	A
4.7	4.7.7	The President's Management Agenda:  Continue implementation of initiatives associated with the President's Management Agenda within the 5 core areas identified in the Agenda.	A
4.7	4.7.8	NTEU: Continue to work with NTEU and the Cooperation Committee to fully implement the NTEU Collective Bargaining Agreement.	A
4.7	4.7.9	Leadership Legacy: Complete work and issue report of Steering Committee and Task Forces. Establish Senior Leadership Board. Implement Leadership Legacy initiative across CFSAN.	A
4.7	4.7.10	Develop a new system for budgeting research projects.	B