Enclosure #1: This workplan began with a total of 123 "A-list" goals, and through June 30, we have completed 45 of these A-list goals. Brief descriptions of these accomplishments are listed in enclosure #1 of this document.

Enclosure #2: We are often tasked with responding to unanticipated issues emerging throughout the year. This section (enclosure #2) lists "new" priority issues requiring CFSAN’s attention that surfaced after publication of the FY 2005 Program Priorities Document.

Enclosure #3: Sometimes we have to revise goals based on new information that we receive on the issue after publication of the Program Priorities Document. This section shows any modifications to goals to accurately reflect our desired outcome.

Enclosure #4: We moved a number of A-list goals to the B-list to give us the space we need to address and respond to the unanticipated work affecting resources initially devoted to accomplishing our FY 2005 Program Priorities. This section lists the A-list goals that we moved to the B-list.

Food Security: Implementing New Legislation

1. Publication of the Establishment and Maintenance of Records Final Rule: On December 9, 2004, published in the Federal Register (69 FR 71561) a final regulation entitled: "Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." The final regulation requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States.

   Final Rule on Establishment and Maintenance of Records (69 FR 71561)

2. Establishment and Maintenance of Records Small Entity Compliance Guide: Published a Small Entity Compliance Guide as a booklet entitled: "What You Need to Know About Establishment and Maintenance of Records". This booklet informs domestic persons in the U.S. who manufacture, process, pack, transport, distribute, receive, hold or import food for humans or animals, and foreign persons who transport food in the U.S., about a final regualtion that establishes requirements regarding the establishment and maintenance of records. Spanish and French versions were published in May 2005.

   What You Need to Know About Establishment and Maintenance of Records (available in PDF)

3. Administrative Detention Guidance to Industry: Published guidance entitled: "What You Need to Know About Administrative Detention of Foods ". This guidance informs food manufacturers, processors, packers, transporters, importers and exporters about expedited procedures for perishable foods as well as procedures describing how FDA will detain an article of food and the process for appealing a detention order.

   What You Need to Know About Administrative Detention of Foods (available in PDF, 305 Kb)

Seafood Safety

4. Seafood HACCP: Completed an evaluation of program performance through the sixth year, with an emphasis on identifying factors that may be inhibiting improvements in compliance rates.

   Based on FDA's historical compliance classification system, approximately 91% of firms were in compliance through the sixth year of the Seafood HACCP Program. This is a significant increase over the 85% compliance rate of 2001. FDA intends to continue to prioritize all manufacturers of high risk fishery products, particularly processors of scombroid species and cooked ready-to-eat products, for annual inspection and to complete an evaluation of firms that need a HACCP plan but still do not have one and determine what follow up action is needed to ensure compliance on this issue.

5. Environmental Working Group Information Quality Appeal: In May 2005, responded to the Environmental Working Group's (EWG) appeal to their Information Quality Act Request for Correction of the FDA Seafood Advisory Entitled: "What You Need to Know About Mercury in Fish and Shellfish."

Egg Safety Action Plan

6. Egg Safety - In-lid Labeling: On May 5, 2005, published in the Federal Register (70 FR 23813) a proposed rule entitled: "Food Labeling: Safe Handling Statements: Labeling of Shell Eggs." This notice proposes to amend the Agency's food labeling regulations to permit the egg industry to place the safe handling statement for shell eggs on the inside lid of egg cartons if the statement "Keep Refrigerated" appears on the principal display panel (PDP) or information panel.

   Federal Register (70 FR 23813)

7. Egg Safety Public Meetings: On September 22, 2004, published in the Federal Register (69 FR 56823) a proposed rule for egg safety national standards. To solicit public comment on the proposed rule, FDA held three public meetings. These meetings were held on October 28, 2004, College Park, MD; November 9, 2004, Chicago IL and November 16, 2004, Los Angeles CA.
   
   A transcript of the proceedings from these public meetings, as well as all information and data submitted voluntarily to FDA during the public meetings, will become part of the administrative record.

   Egg Safety

Fruits and Vegetables

8. Public Meeting on Sprout Safety: On May 17, 2005, FDA held a public meeting to elicit information on the current science related to foodborne illness associated with the consumption of sprouts. In October 2004, FDA released a produce safety action plan entitled "Produce Safety from Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption" (Produce Action Plan). One item in the Produce Action Plan is to initiate rulemaking to minimize foodborne illness associated with the consumption of sprouted seeds.

   Sprout Safety Public Meeting

9. Guidance on Enforcement Discretion for Ozonation of Juice: Issued guidance for industry entitled "Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes." This guidance addresses the use of ozone to treat apple juice to meet the pathogen reduction requirements of 21 CFR Part 120 "Hazard Analysis and Critical Control Point (HACCP) Systems" (the juice HACCP regulation) and 21 CFR 101.17(g) "Juices that have not been specifically processed to prevent, reduce, or eliminate the presence of pathogens" (the juice labeling regulation). The guidance notes that FDA is currently unaware of any validated treatments for juice using ozone.

   Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes

10. Safe Juice Processing Video: In November 2004, FDA/CFSAN provided technical assistance to the California Department of Health Services, Food and Drug Branch, in cooperation with the Centers for Disease Control & Prevention, university researchers, and industry representatives, in the development of an educational video to assist the industry in producing safer juice.

    Safer Processing of Juice video

Listeria

11. NACMCF Report on Ready-to-Eat Foods: House Report 108-193 of the Agriculture Rural Development, Food and Drug Administration and Related Agencies 2004 Appropriations Language directed FDA to provide the Appropriations Committee a copy of the report by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) advising on the necessary scientific parameters for establishing safety-based us-by-date labels for refrigerated ready-to-eat foods to help reduce the incidence of foodborne listeriosis.

    National Advisory Committee on Microbiological Criteria for Foods (NACMCF) (available in PDF, 313 Kb)

Cooperative Programs

12. 2003 Survey of Foodborne Illness Risk Factors in (retail-level) Food Establishments: The report of the results of the 2003 data collection of foodborne illness risk factors in retail-level food establishments was released on September 14, 2004 via CFSAN web posting. Q&A's related to the report were also developed and made available in January 2005 and serve to provide the reader with a better understanding of the report and its contents.

    FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004)

Chemical Contaminants, Pesticides and Other Hazards

13. Acrylamide in Food: In June 2005, published on the CFSAN Website expanded exploratory data on acrylamide in food. This is part of FDA’s continued efforts to investigate how acrylamide is formed in food, seek to identify ways to reduce acrylamide levels, and study the human health risk of consuming acrylamide in food.

    Exploratory data on acrylamide in Food

14. Dioxin Analysis Results/Exposure Estimates: In June 2005, published on the CFSAN Web site "FDA Analysis of Food and Feed for Dioxin-like Compounds (DLC)." This analysis was completed as part of specific goals for FDA's Dioxin Monitoring Program to obtain baseline data for DLC levels in food and animal feed ingredients susceptible to DLC contamination and to determine opportunities for DLC reduction by identifying contamination sources that can be eliminated or significantly reduced.

    Dioxin Analysis Results/Exposure Estimates

15. Furan in Food: In June 2005, published on the CFSAN Web site expanded exploratory data on furan in food. FDA is now posting furan data that were collected through November 18, 2004. Data are presented in chronological order with data collected between June 10, 2004 and November 18, 2004. FDA is presenting these data to inform the public of FDA's progress and to help stimulate research into the formation of furan in food. The results reflect furan levels detected in samples of individual food products.

    Exploratory Data on Furan in Food Data through November 18, 2004

16. Survey of Foods for Perchlorate: In February 2005, in conjunction with FDA's Office of Regulatory Affairs (ORA), issued an expanded survey assignment to determine perchlorate levels in 450 samples of various domestic and imported foods. The first phase of the assignment called for collection and analysis of 240 food samples that include fresh fruits and vegetables, fruit juices, and grain products. The second phase of the assignment called for collection and analysis of additional samples of fresh fruits and vegetables, fruit juices, and grain products and seafood.
17. Proposed Rule for Arsenic in Bottled Water: On December 2, 2004, published in the Federal Register (69 FR 70082) a proposed rule to amend FDA's bottled water quality standard regulations by revising the existing allowable level for the contaminant arsenic. This notice proposes to ensure that the minimum quality of bottled water, as affected by arsenic, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards.

    Federal Register (69 FR 70082)

18. Final Rule for Arsenic in Bottled Water: On June 9, 2005, published in the Federal Register (70 FR 33694) a final regulation for arsenic levels in bottled water. The final regulation requires manufacturers to monitor their finished bottled water products for arsenic at least once each year and to monitor their source water for arsenic as often as necessary, but at least once every year.

    Federal Register (70 FR 33694)

19. Final Generic "Channels of Trade" Guidance: On May 18 2005, published in the Federal Register (70 FR 28544) guidance for industry entitled "Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for which Tolerances have been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations." This guidance presents FDA's general policy for implementing the channels of trade provision in the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996, for food containing residues of pesticide chemicals, for which tolerances have been revoked, suspended, or modified pursuant to dietary risk considerations.

    Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for which Tolerances have been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations

20. Foodborne Chemicals Workshop: On May 2-6, 2005, CFSAN, in conjunction with JIFSAN, co-sponsored a workshop, in Annapolis, Maryland, on methodologies for assessing and estimating exposure of food-borne chemicals. The workshop was convened to update the principles and practices of exposure assessment for chemicals in food. The end product of the workshop was a draft report that will undergo further revisions and then publish under the auspices of the WHO/FAO.

Food Allergens

21. Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food: On June 17, 2005, announced in the Federal Register (70 FR 35258) the availability of a draft report entitled: " Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food." The draft report, prepared by an interdisciplinary group of scientists from CFSAN, was prepared to facilitate the further development of CFSAN's policy for food allergens, including the Center's implementation of the Food Allergen labeling and Consumer Protection Act of 2004 (FALCPA).

    Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food

Dairy Safety

22. Federal Imported Milk Act CPG: On April 13, 2005, announced in the Federal Register (70 FR 19489) the availability of a compliance policy guide entitled: "Sec. 560.400 - Imported Milk and Cream - Federal Import Milk Act (CPG 7119.05)." The CPG provides guidance on the applicability of the Federal Import Milk Act (FIMA) to imported milk and cream.

    Sec. 560.400 - Imported Milk and Cream - Federal Import Milk Act (CPG 7119.05)

Education

23. Consolidation of CFSAN's Consumer and Outreach Activities: On January 14, 2005, CFSAN announced the formation of the new Office of Food Safety, Defense, and Outreach (OFSDO), which consolidates the Center's outreach and education activities. OFSDO now serves as the overall Center lead responsible for coordinating, developing, and delivering high-quality outreach and education products to our stakeholders (e.g., consumers, industry, health professionals, and other regulatory authorities). This organizational change is designed to improve the quality, quantity, and timeliness of CFSAN outreach and education.

    CFSAN announced the formation of the new Office of Food Safety, Defense, and Outreach (OFSDO)

24. Listeria Education Program: In FY2005, CFSAN carried out multicultural food safety initiative educational program for pregnant women through Hispanic media and community-based public health specialists in high density Spanish-speaking areas on the risk of Listeria monocytogenes in cheeses.

Nutrition Health Claims and Labeling

25. Establish FDA's Obesity Working Group (OWG2): Established the Obesity Working Group 2 to carryout the short-term and long-term recommendations for dealing with the Nation's obesity problem set forth by OWG 1 in FY 2004. A detailed matrix of the status of the OWG 1 Report recommendations has been maintained and updated periodically and shared with appropriate CFSAN staff and FDA senior management.
26. Keystone Forum: Participated, along with representatives of academia, industry and government, in the first plenary session of the "Keystone Forum on Away-From Home Foods: Opportunities for Preventing Weight Gain and Obesity " on April 26-27, 2005 in Washington, D.C. The 2-day forum session focused on building a shared understanding of the market and nutritional aspects of away-from-home foods, as well as opportunities to begin to identify potential avenues for action.

    The next meeting of the Keystone Forum was scheduled for July 21-22, 2005, and it focused on aspects of consumer behavior, consumer-oriented nutrition information, nutrition education, and marketing communication (commercial and social).

27. Prominence of Calories: On April 4, 2005, published in the Federal Register (70 FR 17008) an advance notice of proposed rulemaking (ANPRM) entitled "Food Labeling: Prominence of Calories." The purpose of the ANPRM is to request comment on whether to amend certain provisions of the Agency's nutrition labeling regulations to give more prominence to calories on food labels. The ANPRM was issued response to recommendations of the Obesity Working Group 1 (OWG 1), which was created by the Commissioner of Food and Drugs to develop an action plan to address the Nation's obesity problems.

    Federal Register (70 FR 17008)

28. Serving Size: On April 4, 2005, published in the Federal Resister (70 FR 17010) an advance notice of proposed rulemaking (ANPRM) entitled: "Food Labeling: Serving Sizes of Products that can Reasonably be Consumed At One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes." The purpose of the ANPRM is to request comment on whether to amend certain provisions of the Agency's nutrition labeling regulations concerning serving size. FDA is issuing this ANPRM in response to recommendations of the Obesity Working Group 1 (OWG 1), which was created by the Commissioner of FDA to develop an action plan to address the Nation's obesity problem.

    Federal Resister (70 FR 17010)

29. Dietary Guidelines: Participated in the review and dissemination of public information on the "2005 Dietary Guidelines for Americans."

Dietary Supplements

30. Premarket Notification Program for New Dietary Ingredients - Public Meeting: On November 15, 2004, held a public meeting about the premarket notification program for New Dietary Ingredients (NDIs). FDA solicited comments from industry, consumers, and other interested members of the public concerning the content and format requirements for NDI notifications made under the Federal Food, Drug, and Cosmetic Act (the Act).
31. Dietary Supplements: Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA): On November 9, 2004, announced in the Federal Register (69 FR 64957) the availability of the strategy for the further implementation of DSHEA. The strategy sets forth a series of specific, integrated research and regulatory measures, including guidance, regulations, and science-based compliance and enforcement mechanisms. By implementing these measures, CFSAN hopes to improve the transparency, predictability, and consistency of both its scientific evaluations of dietary supplement products and ingredient safety, and of its regulatory actions to protect consumers against unsafe dietary supplements and dietary supplements making unauthorized, false or misleading claims. CFSAN expects that this improved transparency will help engage stakeholders in developing further measures to implement DSHEA.
32. Dietary Supplement Labeling Guide: On April 2005, published on the CFSAN Web site guidance for industry entitled: "A Dietary Supplement Labeling Guide." This guide was prepared to help assure that dietary supplements sold in the U.S. are properly labeled. This guide applies to dietary supplements produced domestically as well as those produced in foreign countries.

    A Dietary Supplement Labeling Guide

Cosmetics

33. Alpha Hydroxy Acids Guidance: On January 10, 2005, announced in the Federal Register (70 FR 1721) the availability of a guidance document entitled:" Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients." The guidance recommends content for a labeling statement for cosmetic products containing alpha hydroxy acids (AHAs) as ingredients. This action was prompted by a citizen petition filed by the Cosmetic, Toiletry, and Fragrance Association, which requested that FDA issue a regulation establishing labeling requirements relating to sun protection with use of cosmetic products containing AHAs.

    Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients

Science Base

34. Social Science Research on Connections between Food Labeling and Weight Management: In April 2005, prepared a summary that reports weighted frequencies based on the FY 2004 Health and Diet Survey (HDS) Supplement that assessed consumer's knowledge and understanding of carbohydrates, diets based on limiting carbohydrates, and carbohydrate claims in the marketplace (e.g., net carbs).
35. Adverse Event Data Management at FDA: On June 18, 2005, implemented cross-center training program for new hires using a clinical and epidemiology training module based on real adverse event data analyses from FDA. Participants comprised staff from all FDA centers.
36. Consumer Knowledge of Trans fats, Saturated fats and Omega-3 fats: In an effort to inform consumers about how much trans fat, saturated fats and Omega-3 fats are in the foods that we eat and the risk posed by eating too much of these fats and acids, CFSAN has begun an effort to increase consumer knowledge by 40% for trans fat, by 10% for saturated fat, and by 10% for omega-3 fatty acids based on the completion of the FY 2004 and FY 2007 Health and Diet Survey (HDS). During FY 2005, CFSAN collected, compiled and analyzed baseline data begun in FY 2004 for these fats and acids. The 2004 Health and Diet Survey Supplement surveyed consumer awareness of fatty acids (saturated, trans, and omega-3) and their knowledge of the link between fatty acid consumption and risk for coronary heart disease.

International

37. SPS Agreement: In FY 2005, CFSAN staff coordinated FDA scientific and technical review of 98 proposed foreign Sanitary and Phytosanitary (SPS) measures relating to FDA's food and feed safety jurisdictional areas that were notified by Member Countries to World Trade Organization (WTO) under the SPS Agreement. CFSAN drafted U.S. comments on 40 of these notifications, i.e., those that warranted comment (as of 4/29/05). The comments were subjected to interagency collaboration and sent to the U.S. Enquiry Point for submission to the appropriate foreign government. CFSAN anticipates an additional 75 notifications to be reviewed with comments by the end of FY 2005.
38. AFDO Working Group Activity: In accordance with the Association of Food and Drug Officials' (AFDO) charge for 2004-2005, chaired a working group composed of industry, states and federal agencies and:
    • Published a harmonized model system for state food export certificates;
    • Encouraged at least 80% of the states to develop export certificate websites and capture the updated links on the website;
    • Tested the harmonized state export certificates for acceptability by other country governments;
    • Requested information on export certificate requirements of importing countries through a new Food and Agricultural Import Regulations and Standards (FAIRS) Report from USDA-FAS posts abroad, to be posted and updated annually on the website beginning September 2005; and
    • Completed work to enable U.S. export certificate website to go "live."
39. International Technical Assistance Activities: CFSAN collaborated with USDA to develop a combined database ("metadatabase") to include all U.S. federal international technical assistance activities. CFSAN created a vehicle to make this information more accessible to diverse federal agencies participating in SPS-related technical assistance, through a new feature "Technical Assistance/Trade Capacity Building Issues" in the SPS/TBT Weekly News.

Internal Processes

40. CFSAN Regulations Writing Consolidation: CFSAN has implemented several changes toward the consolidation of its regulations writing function within the Center. In late FY 2004, the responsibility of the regulation writing function and managing of the CFSAN process for planning, developing, and clearing regulations was delegated to CFSAN's Office of Regulation and Policy (ORP). In FY 2005, in an effort to promote efficiency and effectiveness in the regulations development operations, CFSAN's Economics Team and its Consumer Studies Team formerly located in CFSAN's Office of Scientific Analysis and Support were moved to ORP. These two staffs report to a newly created position of Associate Director for Social Sciences within ORP.

    Realignment of the Economics Team and the Consumer Studies Team to ORP, as well as creation of the new Associate Director for Social Sciences is not only another step toward streamlining Center operations, it also will enhance the Center's ability to complete high quality rulemakings in a timely fashion. In subsequent years, CFSAN will perform a review to determine if the Center has improved this function.

Focused Economic-based Regulations

41. FDA/FSIS Standards of Identity (General Principles): On May 20, 2005, published in the Federal Register (70 FR 29214) a proposed rule entitled: "Food Standards; General Principles and Food Standards." This is a joint proposal between the Food Safety and Inspection Service (FSIS) under the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA).
    
    The FDA and FSIS are proposing to establish a set of general principles for food standards. The proposed general principles will establish the criteria that the agencies will use in considering whether a petition to establish, revise, or eliminate a food standard will be the basis for a proposed rule. In addition, each agency may propose to establish, revise, or eliminate a food standard on its own initiative or may propose revisions to a food standard in addition to those a petitioner has requested. These proposed general principles are the agencies' first step in instituting a process to modernize its standards of identity (and any accompanying standards of quality and fill of container) and standards of composition.

    Federal Resister (70 FR 29214)

Management Initiatives

42. Zero-based Budget Process (ZBB): This was the first year that CFSAN relied on zero based budgeting to ensure that financial resources required to meet the Center's needs are allocated in an economic and efficient manner. The result of this process was much additional savings with reduced funding. We were able to limit each Office to 75% of their previous funding levels and the Offices managed to allocate their funds to meet their needs. The biggest change we accomplished by adopting ZBB was that we were able to identify program areas within each Office and make funding recommendations based on program needs.
43. Decommissioning Federal Building 8 (FB-8): The chemical and radioactive decommissioning of FB-8 is complete. CFSAN has submitted the final report, called the Final Status Survey, to the Nuclear Regulatory Commission (NRC). On June 6, 2005, the NRC officially released the FB-8 facility for unrestricted use. CFSAN has completed all of its obligations to the FB-8 decommissioning project.
44. CFSAN's Adjunct Building: University Station: In the fall of 2004, completed construction and occupancy of a second building called "University Station," located next door to the Harvey Wiley Building. This marks the end of a significant milestone in the relocation of nearly all CFSAN headquarters staff to a single location. The building is fully furnished and all laboratories are operational.
45. 1^st Year Phase of the CFSAN Leadership Legacy Initiative: In FY 2005, CFSAN initiated the application process for two leadership development opportunities targeted for career/career conditional, full-time CFSAN employees who have demonstrated leadership potential and who are currently in non-supervisory positions. The first opportunity will be for selected employees to perform a one-year detail with the Office of the Center Director on the Executive Operations Staff (EOS). The second opportunity will be for selected employees to participate in CFSAN's newly established "Leaders Developing Leaders (LDL)" Program. The launch of these two opportunities represents a key step in shifting to a more intentional, systematic and Center-focused approach to the development of CFSAN's future leaders.

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Enclosure 2

FY 2005 Program Priorities
"New Priorities"

The following eleven new goals emerged as a high priority after publication of the FY 2005 Program Priorities Document. These goals are all targeted for completion before the end of FY 2005.

1. In cooperation with the Interstate Shellfish Sanitation Conference, reassess the appropriateness of the method of calculating the level of illness reduction for Vibrio vulnificus in raw Gulf Coast oysters, especially the number of illness reporting states included in the calculation, and recommend changes for Conference adoption as appropriate.
2. Hold Public Meeting on the Risk Assessment on Vibrio parahaemolyticus in Raw Oysters.
3. Conduct outreach to consumers, industry and state regulators regarding untreated cider or juice not processed under HACCP.
4. Disseminate Public Information on the "2005 Dietary Guidelines for Americans."
5. Respond to Environmental Working Group on Methylmercury.
6. Publish Expanded Exploratory Data on Acrylamide.
7. Publish Expanded Exploratory Data on Furan in Food.
8. Publish Data on Dioxins.
9. Publish Dietary Supplement Labeling Guidance for Industry.
10. Begin to incorporate the recommendations and outcomes of the Interstate Shellfish Sanitation Conference (ISSC) and incorporate, as appropriate, changes into the National Shellfish Sanitation Program (NSSP) Model Ordinance.
11. Begin to incorporate the recommendations and outcomes of the National Conference on Interstate Milk Shipments (NCIMS) and incorporate, as appropriate, changes into the Pasteurized Milk Ordinance (PMO).

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Enclosure 3

FY 2005 Program Priorities
"Modifications"

The following goals have been revised as a result of new information after issuance of our Program Priorities Document. The following goal has been revised.

Revised A-list Goals
1.	Original Wording:1.4.1 - Publish analysis of all data gathered to date world-wide on the good aquaculture practices project in preparation for the drafting of guidance. Revised Wording:1.4.1 - Submit for publication papers based on data collected world-wide in preparation for drafting guidance on seafood Good Aquaculture Practices.
2.	Original Wording:1.5.3 - Hold a public meeting on sprout safety and initiate rulemaking (ANPRM) for sprouts. Revised Wording:1.5.3 - Hold a public meeting on sprout safety and evaluate outcome of the meeting.
3.	Original Wording:1.12.9 - Issue report on allergen inspections. Revised Wording:.12.9 - Complete report on allergen inspections.
4.	Original Wording:1.12.6 - Complete an Association of Official Analytical Chemist (AOAC) interlab study for immunochemical peanut protein test kits following the AOAC harmonized validation protocol. Revised Wording:1.12.6 - Initiate an Association of Official Analytical Chemist (AOAC) interlab study for immunochemical peanut protein test kits following the AOAC harmonized validation protocol.
5.	Original Wording:1.13.2 - Issue revised dairy based CPGs to reflect current practices and remove outdated CPGs. Revised Wording:1.13.2 - Develop draft dairy based CPGs to reflect current practices and remove outdated CPGs.
6.	Original Wording:1.8.6 - Draft and Publish 2005 PMO and ISSC Model Ordinances Revised Wording:1.8.6 - Begin to incorporate the recommendations and outcomes of the Interstate Shellfish Sanitation Conference (ISSC) and incorporate, as appropriate, changes into the National Shellfish Sanitation Program (NSSP) Model Ordinance. 1.8.7 - Begin to incorporate the recommendations and outcomes of the National Conference on Interstate Milk Shipments (NCIMS) and incorporate, as appropriate, changes into the Pasteurized Milk Ordinance (PMO).

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Enclosure 4

FY 2005 Program Priorities:
"Deletions from the A-list"

Due to the additional high priority activities that emerged after the publication of the FY 2005 "Priorities Document, " and resource availability we have moved the following goals to the "B-list " for the remainder of FY 2005. This means FDA will continue to work on these goals as time permits, but we will not expect final action this fiscal year. These goals will be evaluated for inclusion the A-list in our FY 2006 Program Priorities Document.

"Moved to B-list "

1. Publish final rule to set standards for the use of private laboratories and for testing imported foods.
2. Issue draft guidance advising processors on steps to reduce Listeria monocytogenes (Lm) contamination in ready-to-eat foods.
3. Issue a field assignment regarding "gourmet" raw milk soft cheeses.
4. 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.
5. Issue revised final guidance for lead levels in candy.
6. Update the pesticides Compliance Policy Guide (CPG) to bring it in line with Food Quality Protection Act (FQPA).
7. Publish final rule on BSE recordkeeping.
8. Finalize Interim Final Rule for Bovine Spongiform Encephalopathy (BSE).
9. Issue allergen compliance program and implement enforcement strategy.
10. Complete evaluation of the science of raw milk cheeses. (60 day aging).
11. Publish an Advance Notice of Proposed Rulemaking (ANPRM) to solicit comments on updating Daily Values in nutrition labeling.
12. Publish draft guidance on the evidence-based ranking system for health claims and qualified health claims.
13. Publish a proposed rule to amend 21 CFR 190.6 relative to description of new dietary ingredients.
14. Publish proposed rule to revise, as appropriate, existing regulation that requires irradiated food to be labeled.
15. Publish a final rule for infant formula Good Manufacturing Practice (GMP) and quality factors.
16. 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.
17. Conduct a program review of research on dietary supplements and develop a strategic plan for research.
18. Host a meeting of academic research institutions to discuss CFSAN research needs and potential mechanisms for enhancing the interaction of the Center with its academic partners.
19. Improve CFSAN's workplanning process so that it includes incorporation of risk-based priorities, best practices, and development of a multi-factorial risk model for both domestic and import operations.
20. 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.
21. 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 hazard(s) and determining the consequences to the public health as a result of agency action vs. inaction.
22. Publish proposed rule/direct rule to revise 21 CFR 113.40 to permit use of alternative temperature-indicating devices, as well as mercury-in-glass thermometers.
23. Modify selected CFSAN Compliance Programs, EIR formats and the IOM so that during domestic inspections investigators examine, report, and track counterfeit imported products, returns of imported products, and complaint files concerning imported products.