CFSAN 2006 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 2006 Program Priorities for FDA's Center for Food Safety and Applied Nutrition (CFSAN).  This document lays out the Center's work product expectations to support our Program Priorities for the current fiscal year 2006 (October 1, 2005 through September 30, 2006), and is based on comments we received from you (our stakeholders) as well as comments generated internally.  Our focus is 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.

The FY 2006 document is structured differently than previous years.  We have divided our workplan into five primary sections that represent the overarching goals of the Center:

1. Ensuring Food Defense
2. Ensuring Food Safety
3. Improving Nutrition
4. Ensuring Dietary Supplement and Cosmetic Safety and Management Services
5. Priority Ongoing Activities

The workplan very much focuses on high priority areas that help ensure the safety of our regulated products. This workplan was developed in recognition of a diminished budget, including projected reductions and redeployment of resources to achieve funding for priorities, including pandemic flu, outlined in the President's FY 2007 budget which was released on February 6, 2006. In FY 2006, the Agency and CFSAN have been presented with unique challenges, and we will not be able to take on the same large number of objectives we have identified in previous years. The challenges are likely to continue in FY 2007 and beyond for domestic agencies in the Federal Government. To meet these challenges, we will refocus our resources to areas where we can do the most good to protect the public health. CFSAN is facing numerous challenges as a result of a reduction of personnel over the past several years (Figure 1). From a high of 950 Full-Time Equivalent (FTE) positions in FY 2003, we have seen a decrease to 894 FTE positions in FY 2005 and to fewer than 850 FTEs currently on board. Moreover, CFSAN recently received authorization to offer, this fiscal year, Voluntary Early Retirement (also known as Early Out retirement) with Voluntary Separation Incentive Payments (also known as buy outs). This will have a significant impact on the priority items we can complete.

In addition, our operating funds have shown an uneven and decreasing funding level over the past several years, from a high of $47.6 Million in FY 2003 to an operating budget of $30 million for FY 2006 (Figure 2). Based on current forecasts, including the President's FY 2007 Budget, we expect that we will not be able to realize any significant increases in funding and, more importantly, we project that funding levels will decrease. We will most likely have to absorb a cost-of-living pay raise with inflation at the current rate of about 3-4% and no additional increase in funding to compensate our base budget. This will unquestionably affect the Center's ability to support our Program Priorities.

Fully recognizing the current budget constraints, CFSAN has taken proactive measures to be able to respond to these economic realities. 

Last year, we established task forces on Program Priorities, Business Efficiencies, and Personnel, to assess the current budget and resource situation, and we worked to develop strategies that allocate available resources most efficiently to CFSAN's core mission.

CFSAN also implemented a Zero-based Budgeting (ZBB) process that included a comprehensive review of programs within the Center to ensure optimal use of resources and if necessary to help us redirect resources to support the Center's highest priorities.  We plan to reduce funding for programs identified as no longer needing to be continued at the current resource level as well as to identify those specific programs that cannot be properly operated with the resources allotted and, thus, are candidates for closure. 

In FY 2006, Food Safety and Food Defense remain a central theme for FDA and our workplan reflects this continued focus and commitment to protect the public health. In addition, we will increase our focus on Nutrition and maintain an active presence in important areas such as Dietary Supplement safety and Cosmetics. We have identified two Management Initiatives as very important priorities that will have a profound effect on the future of the Center. One priority is the "Leaders Developing Leaders" program. Our first "Leaders Developing Leaders" program class started in early FY 2006 and will help prepare CFSAN's next generation of leaders. We are also examining other management processes to increase internal efficiencies through re-allocation of personnel.

Another change in our FY 2006 Program Priorities Book is that it only includes what were previously listed as "A-list" items. This year's plan identifies 62 deliverables we expect to complete. Our goal is to complete at least 90% of these items by the end of the current fiscal year, September 30, 2006. Unlike in the past, the FY 2006 Program Priorities do not include "B-list" priority activities where we intend to make significant progress on during the year. The category entitled "Priority Ongoing Activities" is still included. These are activities that the Center performs on a regular basis. I want to stress that many of these "Priority Ongoing Activities" are core functions and among our very highest priorities, and that the Center still intends to make progress on these multi-year and major activities. However, we want to use the Program Priorities plan to highlight those activities that are both most critical to the mission of the Agency and that we intend to complete during the year.

A new element of our FY 2006 Program Priorities book is to highlight our critically important research activities with an asterisk.  FDA is a science-led organization and the research CFSAN conducts provides the cornerstone of good regulatory decisions and enforcement activities.  

Science and sound regulation are inseparable at FDA and research is the foundation for daily decisions on a wide range of CFSAN-regulated products that affect public health. I believe that it is important to highlight the importance of this core activity.

I thank you, our stakeholders, for your continuing support and understanding during these challenging times.  Your support for the Center's critical mission is important to ensure our ability to focus on these program priorities. 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. Food Defense

   • Regulations and Guidance
   • Research
   • Preventive Measures

2. II. Food Safety

   • General
   • Food Additives
   • Food Allergens
   • Bioengineered Foods
   • Transmissable Spongiform Encephalopathies (TSEs)
   • Chemical Contaminants, Pesticides and Other Hazards
   • Egg Safety
   • Cooperative Programs
   • Codex Alimentarius
   • Produce Safety
   • Listeria
   • Seafood Safety
   • Research
   • Dairy Safety
   • Education/Outreach

3. III. Nutrition

   • Nutrition/Preventing Obesity
   • Food Labeling
   • Nutrient Content Claims
   • Infant Formula

4. IV. Ensuring Dietary Supplement and Cosmetic Safety and Management Services

   • Dietary Supplements
   • Cosmetics
   • Management Services

5. V. Priority Ongoing Activities

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Part I
Ensuring Food Defense

1.1.1	Publish a final rule for the establishment of prior notification requirements for imported food shipments.

1.2.1	* Complete construction and associated tasks needed to support certification of a BSL3/ABLS3 laboratory.
1.2.2	* Establish repository of curated E. coli O157:H7 strains and supporting database as reference collection for Department of Homeland Security.
1.2.3	* Develop DNA microarray, genome optical mapping, and bioinformatics analysis for forensic identification of E. coli O157:H7.
1.2.4	* Evaluate mass spectrometric based methods, developed by the Centers for Disease Control and Prevention, for their applicability to the detection and confirmation of botulinum neurotoxin in foods.

1.3.1	Conduct at least six (6) CARVER (Criticality-Accessibility-Recuperability-Vulnerability-Effect-Reconcilability) + Shock vulnerability assessments with associated training with industry and state volunteers.

Part II
Ensuring Food Safety

2.0.1	Develop a proposed rule to modernize the food cGMP requirements.

2.1.1	Publish draft updated chemistry guidance for recycled plastics.

2.2.1	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.
2.2.2	Issue allergen Compliance Program and implement enforcement strategy.
2.2.3	Publish a proposed rule for gluten-free labeling in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
2.2.4	Publish the revised report: Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food.
2.2.5	Publish guidance to industry that addresses the status, under section 403(w) of the Act, of residues of a major food allergen that have been unintentionally incorporated into a food as the result of cross-contact.
2.2.6	Publish guidance to industry that addresses how FALCPA requirements apply to lecithin derived from soy when used as a release agent.

2.3.1

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.

2.4.1	Publish final rule on Bovine Spongiform Encephalopathy (BSE) recordkeeping.
2.4.2	* Complete risk assessment to determine potential of Chronic Wasting Disease (CWD) in infected cervids as a human health risk.

2.5.1	Issue draft guidance for lead levels in candy.
2.5.2	Issue draft updated pesticides Compliance Policy Guide (CPG).

2.6.1	Publish Egg Safety final rule.

2.7.1	Achieve an increase of at least 20 jurisdictions that are enrolled in the Voluntary National Retail Food Regulatory Program Standards and that are actively implementing at least 2 of the 9 standards.
2.7.2	Publish the 2005 Pasteurized Milk Ordinance with benefit of recent time/temperature/microbial growth research data surrounding dairy products.
2.7.3	Publish the 2005 National Shellfish Sanitation Program Model Ordinance.

2.8.1

Codex Committees and Working Groups: Continue FDA leadership in Codex to provide scientifically sound international public health standards through heading US delegations, continuing interactions with other key government leads, strategic meetings with regional groups of countries, public outreach meetings in the US, coordination with US codex office and Rome secretariats, and assuring adequate FDA participation in Codex committee and commission sessions. Commission Session: Codex Alimentarius Commission Cross-Cutting General Subject Committees: General Principles Food Additives and Contaminants Food Import and Export Inspection and Certification Systems Nutrition and Foods for Special Dietary Uses Food Labeling Food Hygiene Methods of Analysis and Sampling Pesticide Residues Commodity Committees: Milk and Milk Products and Fish and Fishery Products

2.9.1	Issue draft guidance for fresh cut produce.

2.10.1	Issue a draft guidance document advising processors on steps to reduce Listeria monocytogenes contamination in ready-to-eat foods.
2.10.2	* Complete draft Listeria monocytogenes/smoked finfish risk assessment and issue for public comment.
2.10.3	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

2.11.1	* Publish the results of studies (in Granada and Hawaii) on the formation of scombrotoxin in large tuna.
2.11.2	Revise domestic and foreign inspection seafood HACCP compliance program to focus inspections on improving compliance by processors of scombroid species, aquaculture fishery products, vacuum packed fishery products and smoked fishery products with the requirements of the Seafood Hazard Analysis Critical Control Points (HACCP) Regulation.
2.11.3	* Develop and initiate a national study on the levels of viral and bacterial pathogens and indicators in U.S. oysters at retail.
2.11.4	Methylmercury: Complete evaluation of risk of methylmercury in seafood as weighed against nutritional and other health benefits.
2.11.5	Publish the fourth edition of the Fish and Fishery Products Hazards and Controls Guidance.

2.12.1	* 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).
2.12.2	Revitalization of the BAM Manual: Update and post revised edition of the Bacteriological Analytical Manual (BAM) on the CSFAN internet.

2.13.1	Issue draft revised "Pathogens in Dairy Products" Compliance Policy Guide.

2.14.1	Conduct consumer education campaign for allergens (including Gluten-Free).
2.14.2	Co-sponsor the "Reaching At-Risk Audiences and Today's Other Food Safety Challenges" conference (Denver, CO; September 27, 29, 2006) to educate food professionals, public health and medical personnel in proven food safety programs for educating older adults, parents of young children, pregnant women, and immunocompromised persons about critical science-based food safety principles and practices.
2.14.3	Publish safe seafood handling brochure.
2.14.4.	Complete preliminary evaluation of the LACF Pilot International Inspection/Outreach Program for Peru, Chile, Brazil, and Ecuador.

Part III
Improving Nutrition

3.1.1	Publish guidance on the evidence-based scientific review system for health claims (including qualified health claims).
3.1.2	Identify and initiate enforcement actions against dietary supplements that make fraudulent weight loss claims.
3.1.3	Participate in Keystone Center-led national policy dialogue initiative to address aspects of the obesity problem.
3.1.4	Develop and post web-based educational module on healthy weight management.

3.2.1	Develop and promote existing food label education materials, particularly those pertaining to healthy lifestyles and combating childhood obesity.
3.2.2	Publish an ANPRM to solicit comments on updating daily values in nutrition labeling.
3.2.3	Publish a proposed rule to revise, as appropriate, existing regulation that requires irradiated food to be labeled.
3.2.4	Publish a final rule to update nutrient values for the voluntary nutrition-labeling program.

3.3.1	Publish draft guidance on whole grains.
3.3.2	Publish an ANPRM on certain carbohydrate claims (e.g., "net").
3.3.3	Publish a proposed rule on terms such as "low", "reduced" and "free" for carbohydrate claims.
3.3.4	* Complete consumer studies research and economic data to help develop principles for use of the word "net" and other terms in relation to carbohydrate content.

3.4.1	Re-open comment period on Infant Formula Good Manufacturing Practices (GMP's) and quality factors.
3.4.2	* Develop an improved bacteriological testing method for Enterobacter sakazakii.

Part IV
Ensuring Dietary Supplement
and Cosmetic Safety
and Management Services

4.1.1	Publish a final rule for dietary supplement current Good Manufacturing Practice requirements (cGMPs).
4.1.2	Publish final rule on "per day" labeling for dietary supplements.
4.1.3	Publish draft guidance on New Dietary Ingredient Notifications.

4.2.1	Distribute information about the health hazards associated with tattoo inks, especially permanent make-up inks.
4.2.2	Fully implement an electronic system to support participation via Internet in the Voluntary Cosmetic Registration Program.
4.2.3	Launch web-based information system for Color Certification that will provide essential information to industry about status of their samples and account information and updates from FDA.

4.3.1	Realign CFSAN's Office of Management Systems based on recommendations resulting from the FY 2005 CFSAN work-force analysis.
4.3.2	Implement the CFSAN Leaders Developing Leaders (LDL) program.

Part  V
Priority Ongoing Activities

Food Defense

Research

1. 1.  Conduct intramural and extramural research to determine threat agent characteristics in foods.
2. 2.  Conduct intramural and extramural research to determine threat agent dose response in humans.
3. 3.  Conduct intramural and extramural research to determine threat agent prevention strategies.
4. 4.  Conduct interagency microbial forensics research efforts with the Department of Homeland Security.

Emergency Preparedness

1. 5.  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.
2. 6.  Participate in emergency response exercises.
3. 7.  Complete the annual CFSAN food defense section of the FDA counterterrorism research report to Congress.

Food Safety

General

1. 8.  Conduct rapid response to emergency/outbreaks and issues and contact stakeholders as needed.
2. 9.  Utilize CDC PulseNet in outbreak investigations.
3. 10.  Domestic Inspections: In conjunction with ORA, inspect 5963 of high-risk domestic establishments.
4. 11.  Foreign Inspections: In conjunction with ORA, conduct foreign inspections, contingent upon resources.
5. 12.  In conjunction with ORA, perform physical exams and conduct sample analyses on products with suspect histories.
6. 13.  In conjunction with ORA, complete the evaluation and classification of foreign firm inspections.

Food and Color Additives

1. 14.  Review Food and Color Additive Petitions within the established timeframe.
2. 15.  Review biotechnology final consultations within the established timeframe
3. 16.  Review GRAS notifications (GRNs) within the established timeframe.
4. 17.  Review premarket notifications for food contact substances within the established timeframe.
5. 18.  Maintain CFSAN Bio-research monitoring program (GLP inspections).

Food Allergens

1. 19.  Review labeling exemption notifications and petitions in accordance with the Food Allergen Labeling and Consumer Protection Act and its mandated timeline.

Chemical Contaminants, Pesticides and Other Hazards

1. 20.  In conjunction with ORA, analyze foods collected through the Total Diet Study samples and collect and analyze selected samples for acrylamide.
2. 21.  In conjunction with ORA, collect and analyze 8,000 food samples for pesticides and chemical contaminants.
3. 22.  In conjunction with ORA, collect and analyze samples of seafood for the presence of chloramphenicol.
4. 23.  In conjunction with ORA and FDA's Center for Veterinary Medicine (CVM), analyze human foods and animal feed for dioxins to refine exposure assessment and identify opportunities to reduce exposure.
5. 24.  In conjunction with ORA, analyze additional commodities such as grains, meals, apples and juices for the presence of perchlorate.

Cooperative Programs

1. 25.  Increase the number of States and U.S. Territories that have adopted the Food Code (represented by an increasing percentage of the U.S. population that live in States and territories that have adopted the Food Code). The target increase for FY 2006 is 49 out of 56 States and territories representing 84% of the U.S. population.

International:

1. 26.  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, the Central American Free Trade Agreement (CAFTA), and U.S./Chile SPS Agreement).
2. 27.  Represent FDA in multilateral and bilateral negotiations on the SPS sections of trade agreements (e.g., Andean countries, Thailand).
3. 28.  Security and Prosperity Partnership (U.S., Mexico, and Canada): Participate in appropriate meetings domestically and internationally to accomplish within timeframes those deliverables pertaining to foods in the security and the food and agriculture agendae.
4. 29.  Begin evaluation of the equivalence of the European Union dairy safety system pursuant to our WTO/SPS international and domestic public health commitments to the National Conference on Interstate Milk Shipments (NCIMS).

Seafood Safety:

1. 30.  Work with the ISSC to implement a control strategy for Vibrio vulnificus in raw oysters.
2. 31.  Improve existing guidance on proper on-board handling of seafood to the fishing industry that harvest scombroid species, and provide ongoing educational programs for the seafood industry.
3. 32.  Evaluate seafood industry Hazard Assessment Critical Control Point (HACCP) performance.
4. 33.  Develop and maintain seafood case precedent system to capture those unique aspects of cases that amplify or clarify policy regarding hazards or controls.
5. 34.  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. 35.  Develop risk management strategy for Vibrio parahaemolyticus with the Interstate Shellfish Sanitation Conference.
7. 36.  Develop Good Aquaculture Practices education program with JIFSAN.

Education:

1. 37.  Distribute food safety educational materials in Spanish at health fairs targeting major Hispanic populations.
2. 38.  Distribute brochures in Spanish on the safe handling of produce.

Nutrition

Food Labeling

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

Infant Formula:

1. 40.  Review premarket notifications for new infant formulas within statutory timeframe.

Health Claims

1. 41.  Review nutrient content/health claim notifications and petitions within statutory timeframes.

Dietary Supplements Safety

1. 42.  Review premarket (75-day) notifications for new dietary ingredients within statutory timeframe.
2. 43.  Review 30-day postmarket notifications for supplement claims in a timely manner. 
3. 44.  Identify dietary supplement ingredients/products that raise safety problems, and take appropriate enforcement action.
4. 45.  In conjunction with the Federal Trade Commission, take action against unsubstantiated claims on dietary supplements.
5. 46.  Take enforcement actions against dietary supplements that contain ephedrine alkaloids (ephedra).

Cosmetic Safety

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

Crosscutting Areas

Management Initiatives:

1. 48.  Implement initiatives associated with the President's Management Agenda within the 5 core areas identified in the Agenda.
2. 49.  Work with National Treasury Employees Union (NTEU) and the Cooperation Committee to fully implement the NTEU Collective Bargaining Agreement.
3. 50.  Conduct focus group research and interviews to support the CFSAN Leadership Legacy Training Program.

Internal Processes:

1. 51.  In conjunction with ORA, 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.
2. 52.  Pilot the development and implementation of Quality Management Systems (QMS) within CFSAN's Division of Enforcement through the Quality Systems Framework and the FDA staff Manual guide for QMS.
3. 53.  Foster the collaborative process of implementing the Case Evaluation and Management SOP between CFSAN's Office Compliance and CFSAN scientific, technical and policy offices.
4. 54.  Modify CFSAN's Office of Compliance intranet web site as part of the merge into inside.fda.gov and further expand the site to strengthen its usefulness as a primary source of compliance and enforcement information for field and center staff.
5. 55.  Modify the compliance Reference System (precedent files) IT application to be more user friendly and effective tools in food compliance operations.
6. 56.  Expand the interaction of CFSAN's compliance Management System (CMS) IT application with other FDA IT applications and databases, support CVM and other Centers use of CMS for their compliance offices, and develop and implement SOPs for CMS.
7. 57.  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.

Acquisition of Science-based Knowledge

1. 58.  Conduct translational research on analytical methods development and prevention/intervention strategies for contaminants of the food supply in support of FDA's foods regulatory program.
2. 59.  Integrate the current consortia (National Center for Food Safety and Technology, Joint Institute for Food Safety and Applied Nutrition, and National Center for Natural Products Research) and other formal and informal relationships with academic institutions or other scientific organizations with CFSAN's food safety and defense and applied nutrition programs.
3. 60.  Recruit a breath and depth of pre-eminent scientific expertise for the food Advisory Committee that will be able to address cutting-edge issues on the forefront of science.

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^* = A new element of our FY 2006 Program Priorities Book is to highlight our critically important research activities with an asterisk. FDA is a science-led organization and the research CFSAN conducts provides the cornerstone of good regulatory decisions and enforcement activities. Science and sound regulation are inseparable at FDA and research is the foundation for daily decisions on a wide range of CFSAN-regulated products that affect public health. I believe that it is important to highlight the importance of this core activity.