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May 3, 2006
Letter from Center Director
Table of Contents
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:
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.
Figure 2. CFSAN Operating Funds FY 2000 - 2006 (estimates for FY 2007)
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.
Sincerely,
Robert E. Brackett, Ph.D.
Director
Center for Food Safety and Applied Nutrition
Regulations and Guidance
Research
Preventive Measures
1.1.1 | Publish a final rule for the establishment of prior notification requirements for imported food shipments. |
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1.2.1 | * Complete construction and associated tasks needed to support certification of a BSL3/ABLS3 laboratory. |
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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. |
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General
Food Additives
Food Allergens
Bioengineered Foods
Transmissible 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
2.0.1 | Develop a proposed rule to modernize the food cGMP requirements. |
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2.1.1 | Publish draft updated chemistry guidance for recycled plastics. |
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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. |
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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. |
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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. |
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2.5.2 | Issue draft updated pesticides Compliance Policy Guide (CPG). |
2.6.1 | Publish Egg Safety final rule. |
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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. |
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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: Cross-Cutting General Subject Committees: Commodity Committees: |
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2.9.1 | Issue draft guidance for fresh cut produce. |
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2.10.1 | Issue a draft guidance document advising processors on steps to reduce Listeria monocytogenes contamination in ready-to-eat foods. |
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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. |
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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). |
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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. |
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2.14.1 | Conduct consumer education campaign for allergens (including Gluten-Free). |
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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. |
Nutrition/Preventing Obesity
Food Labeling
Nutrient Content Claims
Infant Formula
3.1.1 | Publish guidance on the evidence-based scientific review system for health claims (including qualified health claims). |
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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. |
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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. |
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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. |
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3.4.2 | * Develop an improved bacteriological testing method for Enterobacter sakazakii. |
Ensuring Dietary Supplement Safety
Ensuring Cosmetic Safety
Management Services
4.1.1 | Publish a final rule for dietary supplement current Good Manufacturing Practice requirements (cGMPs). |
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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. |
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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. |
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4.3.2 | Implement the CFSAN Leaders Developing Leaders (LDL) program. |
* = 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.