CFSAN 2003 Program Priorities
Report Card

Letter from Center Director
Attachment (summary chart and graph)
Final Report - Accomplished (summary list)
Report Card Table of Contents

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Dear Colleague, FDA Foods Community:

I am pleased to provide you with our end-of-the-year "Report Card" on the FY 2003 program priority accomplishments for the FDA Foods Program. These are the "boulders" we pledged to move up and over the mountaintop. This year's plan was our most ambitious yet, with a total of 150 "A-list" goals. As you will see, we exceeded our goal by completing 92% of our "A" List goals (138 out of 150 goals). In fact, this is the second year in a row that we have exceeded our 90% goal! I am very proud of this wonderful success rate. These results reflect a clear management strategy to focus our resources on where we provide the most benefit to American consumers.

This is the fifth year that we have established priorities in FDA's foods program, and I am very proud of our overall results. Attached is a table and companion graph that show how productivity has increased in each of the past five years. This steady rate of success over a five-year period reflects a strategy of setting ambitious but achievable goals, while "raising the bar" each year. The 138 "A" List goals completed this year is nearly double the 73 "A" List goals completed five years ago in FY 99.

The Foods Program is a major participant in FDA's recently-released Strategic Action Plan. You can obtain a copy of this document from FDA's web site (http://www.fda.gov/oc/mcclellan/strategic.html). The Strategic Action Plan identifies five cross-cutting goals aimed at improving health outcomes for Americans: (1) Efficient Science-Based Risk Management, which includes activities aimed at reducing the incidence of foodborne illness; (2) Improving Healthcare Through Better Information to Consumers, which includes revitalization of our "Applied Nutrition" program; (3) Improving Patient and Consumer Safety, which includes our new CFSAN Adverse Event Reporting System; (4) Protecting America from Terrorism, which includes implementation of the new Bioterrorism legislation and other activities aimed at ensuring the security of the nation's food supply; and (5) A Stronger FDA Workforce, which includes a variety of initiatives aimed at ensuring a high quality, diverse and motivated workforce. You will see specific deliverables for these goals in our FY 2004 program priorities document, which will be available in the near future.

Regarding this year's accomplishments, there are three points I would like to highlight.

In closing, I would like to reiterate my continued appreciation for the support I have received from our many stakeholders on this management approach. Our science-based, results-oriented programs are clearly establishing CFSAN as a World Class Organization. We look forward to continuing this tradition of building predictability, transparency and accountability into FDA's foods program. The American public deserves no less.

Sincerely,

Joseph A. Levitt
Director
Center for Food Safety and Applied Nutrition

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FY 2003 Program Priority Status Report

Final Report

Accomplished

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Table of Contents

• Highlights

1. Assuring Food Safety and Security
    
   • Food Security: Implementing New Legislation
   • Food Security: Emergency Preparedness
   • Domestic Inspections
   • Imports and Foreign Inspections
   • Seafood Safety
   • Fruits and Vegetables
   • Listeria
   • Cooperative Programs
   • Chemical Contaminants, Pesticides and Other Hazards
   • Transmissable Spongiform Encephalopathies (TSEs)
   • Food Allergens
   • Education
      
2. Assuring Food & Cosmetic Safety & Improving Nutrition: Specific Program Areas
    
   • Food and Color Additives: Premarket Review
   • Nutrition, Health Claims and Labeling
   • Dietary Supplements
   • Cosmetics
      
3. Assuring Food Safety: Crosscutting Areas
    
   • Science Base
   • International
   • Internal Process
   • Focused, Economic-based Regulations
   • EEO/Diversity Initiatives
   • Management Initiatives
      
4. Items Carried Over to FY 2004 Workplan
    

Highlights: FY 2003 Program Priority Accomplishments

Assuring Food Security (FDA Strategic Action Plan Goal # 4):

• Published four proposed rules to implement the new Bioterrorism legislation: food facility registration, prior notice of imported foods, recordkeeping, and administrative detention.
• Published two interim final rules to implement the new Bioterrorism legislation: food facility registration and prior notice of imported foods.
• Conducted outreach and training on the proposed and interim final rules.
• Developed a new, easy-to-use IT system for food facility registration.
• Developed guidance documents on preventive measures for the food, dairy and cosmetics industries, importers, and retail establishments.
• Conducted more than 78,000 field examinations of imported food shipments entering U.S. ports of entry (goal was 48,000).
• Participated in multiple emergency response exercises.
• Supported development of a national Food Emergency Response Network (FERN).
• Implemented enhanced security plans for CFSAN laboratories.

Revitalizing "Applied Nutrition" (FDA Strategic Action Plan Goal #2):

• Extended qualified health claims to conventional foods.
• Developed a process for reviewing qualified health claim petitions.
• Issued scientific guidance for industry on ranking of scientific evidence for qualified health claims.
• Established a consumer studies research agenda for qualified health claims.
• Increased enforcement against unsubstantiated dietary supplement claims.
• Published a final rule to require that Trans fat be listed on the Nutrition Facts panel. 
• Published an advanced notice of proposed rulemaking to solicit comment on how to enhance consumers' understanding about saturated fat, trans fat and cholesterol in order to make heart-healthy food choices.

Food Safety and other Program Activities (FDA Strategic Action Plan Goals # 1, and 5):

• Completed a risk assessment on the relationship between foodborne Listeria monocytogenes and human health that considers 23 ready-to-eat food categories.
• Developed an action plan on acrylamide in food and issued a field assignment to sample food for the presence of acrylamide.
• Conducted more than 7,000 domestic inspections of firms that produce "high risk" foods (goal was 6,650).
• Analyzed over 11,000 food samples for the presence of pesticides and chemical residues (goal was 8,000).
• Continued outreach to industry and consumers on food allergens and developed a food allergen database.
• Completed the safety evaluation of food and color additive petitions in a timely way.
• Completed review of biotechnology final consultations, GRAS notifications and food contact substance notifications in a timely way.
• Published a proposed rule on good manufacturing practices for dietary supplements and conducted outreach on the proposal.
• Developed a strategy to protect Americans from the potentially serious risks of dietary supplement products containing ephedra/ephedrine.
• Implemented a new CFSAN Adverse Event Reporting System (CAERS) covering all food, dietary supplement, and cosmetic products.
• Completed batch certification of color additives in a timely way.
• Published draft guidance on labeling of cosmetic products that contain alpha hydroxy acids.
• Major participant in international Codex activities: Attended two Codex Commission Session meetings and a Regional Coordinating Committee meeting; provided the U.S. delegate for eight cross-cutting Codex Committees/Task Forces and the alternate delegate for one cross-cutting committee.
• Held one meeting of the Food Advisory Committee and six subcommittee meetings.
• Developed a structured process to systematically implement all of the CFSAN-specific tasks identified under the President's Management Initiative.

Part I: Assuring Food Safety and Security

Food Security: Implementing New Legislation

1. Proposed Rule - Food Facility Registration Requirements: On February 3, 2003, FDA and the Department of Treasury issued a joint notice of proposed rulemaking in the Federal Register (68 FR 5378) to implement the registration provisions in section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). A copy of the proposal can be found on our Web site at: http://www.fda.gov/oc/bioterrorism/bioact.html
2. Proposed Rule - Prior Notification of Imported Foods: On February 3, 2003, FDA and the Department of Treasury issued a joint notice of proposed rulemaking in the Federal Register (68 FR 5428) to implement the prior notice provisions in section 307 of the Bioterrorism Act. The proposed rule's 60-day public comment period ended April 4, 2003. A copy of the proposal can be found on our Web site at: http://www.fda.gov/oc/bioterrorism/bioact.html
3. Proposed Rule - Maintenance of Records: On May 9, 2003, published a notice of proposed rulemaking in the Federal Register (68 FR 25188) to implement the establishment and maintenance of records provisions in section 306 of the Bioterrorism Act. The proposed rule's 60-day comment period ends on July 8, 2003. FDA plans to publish the final rule by the December 15, 2003 statutory deadline. A copy of the proposal can be found on our Web site at: http://www.fda.gov/oc/bioterrorism/bioact.html
4. Proposed Rule - Administration Detention: On May 9, 2003, published a notice of proposed rulemaking in the Federal Register (68 FR 25242) to implement the administrative detention provisions in section 303 of the Bioterrorism Act. The proposed rule's 60-day comment period ends on July 8, 2003. FDA plans to publish the final rule by December 15, 2003. A copy of the proposal can be found on our Web site at: http://www.fda.gov/oc/bioterrorism/bioact.html
5. Outreach for the Four Bioterrorism Proposed Regulations: FDA hosted two public meetings via satellite downlink that were televised around the world to discuss and answer questions about the new proposed regulations developed to implement the four provisions of Title III of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

   The first of the two meetings was held on January 29, 2003, during which the proposed rules implementing section 305 (Registration of Food Facilities) and section 307 (Prior Notice of Imported Food Shipments) were explained. The second meeting was held on May 7, 2003, during which the proposed rules implementing section 303 (Administrative Detention) and section 306 (Maintenance and Inspection of Records for Foods) were explained. A videotape and transcript of the meetings has been translated into French and Spanish and all three versions of the public meetings can be found at FDA's Web site at: http://www.fda.gov/oc/bioterrorism/bioact.html

6. Interim Final Rule - Food Facility Registration: On October 10, 2003, published in the Federal Register (68 FR 58893) an interim final regulation that requires domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003. The interim final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to register with FDA by December 12, 2003, even in the absence of a final regulation. Registration is one of several tools that will enable FDA to act quickly in responding to a threatened or actual terrorist attack on the U.S. food supply by giving FDA information about facilities that manufacture/process, pack, or hold food for consumption in the United States. In the event of an outbreak of foodborne illness, such information will help FDA and other authorities determine the source and cause of the event. In addition, the registration information will enable FDA to notify quickly the facilities that might be affected by the outbreak.
7. Interim Final Rule - Prior Notification of Imported Food: On October 10, 2003, published in the Federal Register (68 FR 58975) an interim final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The interim final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which requires that the prior notification of imported food to begin on December 12, 2003, even in the absence of a final regulation.
8. IT System for Food Facility Registration: This IT system was completed and began operation on October 16, 2003. In conjunction with FDA's Office of the Chief Information Officer, CFSAN helped to define requirements for the system and subsequently tested the "contractor-developed" system. CFSAN will coordinate and post on the CFSAN Web site (WWW.cfsan.fda.gov) all documentation for the Bioterrorism Act for industry access.

   CFSAN has the responsibility for processing information into the registration system and for the System Help Desk.  These projects are being done under contracts starting in October of 2003. Instructions on how to register can be found on our Web site at: http://www.cfsan.fda.gov/~furls/ovffreg.html

9. IT System for Prior Notification of Imported Foods: The IT system for prior notice of imported food is under development by FDA's Office of Regulatory Affairs (ORA) in consultation with CFSAN staff and in conjunction with the Office of the Chief Information Officer. Planned completion is December 2003.
10. Food Section of the FDA Counter Terrorism Research Report to Congress: Title III, subtitle A, section 302 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires FDA to submit an annual report to Congress describing progress made in counter terrorism research. CFSAN has completed a review of its food security research efforts and provided a summary of its activities and accomplishments for FY 2003 to the Office of the Commissioner in June 2003. The full FDA Counterterrorism Research Report for FDA and HHS was transmitted to Congress October 16, 2003.
11. Threat Assessment Report to Congress: CFSAN completed a report to Congress on the external threat assessment of intentional adulteration of food, developed under contract with FDA by the Battelle Memorial Institute [Public Health Security and Bioterrorism Preparedness and Response Act of 2002] (P.L. 107-188). The report is currently going through Administration clearance.

Food Security - Emergency Preparedness

12. Bioterrorism Training: Training on the proposed Bioterrorism regulations has been completed. Food Facility Registration and Prior Notification of Imports training was held on February 25 and March 12, 2003, and 48 CFSAN personnel and 52 FDA and ORA (field staff) attended one or both sessions. On March 11 and May 13, 2003, FDA provided training to officials from all 50 states. Training on the final Bioterrorism regulations is underway. Training for "first responders" was held on October 15, 2003, and 178 CFSAN personnel attended. A worldwide "Satellite downlink" public broadcast on the final regulations for Food Facility Registration and Prior Notification of Imports was held on October 28. The remaining training activities scheduled for November are: (1) an orientation session for all FDA employees responsible for handling and referring inquiries about the Bioterrorism legislation; and (2) specialized Bioterrorism training for FDA speaker and experts.
13. CFSAN Evaluation of Rapid Analytical Testing: CFSAN completed the review of CFSAN's intramural and extramural research efforts to evaluate the applicability of rapid analytical tests for non-traditional pathogens for use with specified food matrices.
14. Nationwide Laboratory Response Network (LRN): In support of the development of the Nationwide Laboratory Response Network, CFSAN, in conjunction with ORA, conducted twelve training sessions in support of the development of the LRN: (1) three satellite broadcasts on Biological Safety Levels Requirements, (2) six classroom/laboratory training sessions; and (3) three training sessions focused on animal handling in a BSL-3 facility.
15. Enhance CFSAN Emergency Response Plan: On May 12, 2003, revised the "CFSAN Emergency Response Plan (CERP)." The CERP will enhance the coordination between CFSAN, the FDA Office of Emergency Operations (OEO), and the FDA Office of Regulatory Affairs (ORA) by defining the roles of all offices during emergency responses involving foods and other products within the purview of CFSAN.
16. Emergency Response Exercises: CFSAN participated in numerous emergency response exercises including all levels of government:
     
    • TOPOFF 2 Exercise - During the week of May 12-16, 2003, CFSAN participated in the TOPOFF 2 terrorism exercise, a full scale, fully functional exercise intended to simulate two separate terrorist acts, as well as the ensuing response for federal, state, and local governments. TOPOFF 2 was a congressionally mandated interagency exercise on a national and international scale.
    • FDA/CFSAN held several internal emergency exercises with the CFSAN Leadership Team, Division Directors/Branch Chiefs and plans to hold exercises with the entire staff of CFSAN in FY 2004.
    • CFSAN participated in numerous internal exercises in FY 2003 - e.g., BSE and a food contamination exercise.
    • CFSAN also participated in exercises with other federal agencies - e.g., Crimson Winter with USDA (Foot and Mouth Disease).
    • CFSAN also participated with HHS in joint exercises with USDA at the Deputy Secretary level.
    • FEMA's Emergency Management Institute conducted a course for FDA entitled "Integrated Emergency Management" from May 20-22, 2003 at the Mount Weather Training Center in Virginia. Thirty-three FDA employees representing FDA's Office of Crisis Management, the Office of Criminal Investigations, and CFSAN participated in the 3-day emergency training course/exercise.
17. Food Safety and Security Guidance - Domestic: On March 21, 2003, published in the Federal Register (68 FR 13931) a final guidance document related to food security entitled: Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance. This guidance is designed as an aid to operators of food establishments (for example, firms that produce, process, store, repack, re-label, distribute, or transport food or food ingredients). It identifies the kinds of preventive measures that operators may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal or terrorist actions. A copy of the final guidance document can be viewed at our Web site at: http://www.cfsan.fda.gov/~dms/secguid6.html
18. Food Safety and Security Guidance - Importers: On March 21, 2003, published in the Federal Register (68 FR 13931) a final guidance document related to food security entitled: Importers and filers: Food Security Preventive Measure Guidance. This final guidance is designed as an aid to operators of food importing establishments, storage warehouses, and filers. It identifies the kinds of preventive measures that they may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal or terrorist action. A copy of the final guidance can be found at our Web site at: http://www.cfsan.fda.gov/~dms/secguid7.html
19. Guidance on Cosmetics Security Prevention Measures: On March 21, 2003, published draft Guidance for Industry titled: Cosmetics Processors and Transporters Cosmetics Security Preventive Measures Guidance. This draft guidance represents the Agency's current thinking on appropriate measures that cosmetics establishments may take to minimize the risk that cosmetics under their control will be subject to tampering or other malicious, criminal, or terrorist actions. A copy of the Guidance can be found on the FDA's website at: http://www.cfsan.fda.gov/~dms/secguid4.html
20. Food Safety and Security Guidance for Retail: On March 21, 2003, published draft Guidance for Industry titled: Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance. This draft guidance represents the Agency's current thinking on the kinds of measures that retail food store and food service establishment operators may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal, or terrorist actions. A copy of the draft guidance can be found at: www.cfsan.fda.gov/~dms/secguid5.html
21. Product-specific Guidance: On July 11, 2003, CFSAN published Guidance for the Dairy Industry entitled: "Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors - Food Security Preventive Measures Guidance. This guidance is designed as an aid to operators of dairy farms, bulk milk transportation operations, bulk milk transfer stations and fluid milk processing facilities. It identifies the kinds of preventive measures operators of these establishments may take to minimize the risk that products under their control will be subject to tampering or other malicious, criminal, or terrorist actions. A copy of the guidance can be found on the CFSAN Web site at: http://www.cfsan.fda.gov/~dms/secguid6.html.
22. Interagency Food Working Group (IFWG): CFSAN, in conjunction with ORA and FDA's Office of Crisis Management, established three subgroups charged with coordinating food security and counter-terrorism issues with the IFWG, organized by the Administration's Homeland Security Council. CFSAN subgroups focus on: (1) laboratory coordination; (2) strategies for reducing risks of intentional contamination (shields); and (3) incident management. Each subgroup meets on a regular basis, and interacts regularly with other Federal Departments, including the United States Department of Agriculture (USDA) and the Department of Homeland Security (DHS).
23. Preventive Measures for Food Processors: CFSAN awarded a contract with the Institute of Food Technologists (IFT) to conduct an in-depth review of preventive measures that food processors may take to reduce the risk for an intentional act of terrorism or contamination for various food commodities and agents.
24. Security Plan for All CFSAN Laboratories: CFSAN completed and placed on the CFSAN intranet a laboratory security document entitled: "Framework for Ensuring the Security of CFSAN Laboratory Facilities: Secure Handling and Use of Select Agents in the Center for Food Safety and Applied Nutrition." This document was developed to provide guidance for establishing and maintaining accountability of hazardous materials, with particular reference to "Select Agents" as required under the Bioterrorism Preparedness and Response Act of 2002.
25. CFSAN Situation Room: The CFSAN Emergency "Situation Room" became operational February 28, 2003. CFSAN staff assigned to manage and operate the "Situation Room" have been selected. Required training sessions/exercises to increase applicable staffs' knowledge and readiness to respond to potential emergency situations associated with food and cosmetic products regulated by CFSAN/FDA were held throughout FY 2003.
26. CFSAN Secure Communications: The CFSAN "Secure Communications Room" became operational February 28, 2003. This room will serve as a work site where secure communication capability will be available to CFSAN staff.
27. CFSAN Alternate Work-site: In the event that the Wiley Building must be evacuated because of a building emergency or employee security emergency, our MOD-I Facility has been designated as the Alternate Worksite for CFSAN personnel. All specialized renovations, including the cabling of the space identified at MOD-I as the CFSAN Alternate work site, has been completed.
28. Operation Liberty Shield: On March 13, 2003, FDA/CFSAN issued an assignment, in conjunction with FDA's Office of Regulatory Affairs (FDA field), to conduct inspections, sample collections and import examinations targeted at specific commodities to reduce the risk that food would be intentionally contaminated, as part of the Federal Government-wide initiative called Operation Liberty Shield.

Domestic Inspections

29. Domestic Inspections: Conducted 7, 363 domestic inspections of firms that produce "high risk" foods (through FDA's Office of Regulatory Affairs and the states, under FDA auspices). This exceeds FDA's goal to annually inspect 95% (6,650) of the "high risk" domestic food establishments.
30. Multi-year Strategy to Enhance FDA Audit and Evaluation of State Inspection Programs: In FY 2003, 20 FDA staff and 20 state auditors were trained in state audit and evaluation of state inspections. New auditing documents including forms and procedures also have been developed and finalized. A Field Management Directive (FMD) is in process to address controlling audits. As of FY 2003, FDA auditors now have 1 year of experience in auditing with the number of audits and results being posted on the FDA web site under "Partnerships/Contracts."

Imports and Foreign Inspections

31. Field Examinations of Imported Food: In conjunction with FDA's Office of Regulatory Affairs, completed 78,659 field examinations of imported food shipments entering U.S. ports of entry for release into the U.S. commerce. Our goal was to complete 48,000 field examinations for the current fiscal year, FY 2003. FDA exceeded its goal by 164 percent. This is more than a 6-fold increase from the 12,000 field import examinations conducted just two years ago in FY 2001.
32. Foreign Inspections: Through FDA's Office of Regulatory Affairs, conducted 147 inspections of foreign food establishments with top priority to "high risk" foods. Due to travel restrictions based on world events, FDA was able to conduct only limited foreign inspections. Many foreign inspections planned for FY 2003 will be rescheduled in FY 2004.
33. Foreign Inspection Evaluation and Classification: CFSAN continues to receive FY'03 foreign Establishment Inspection Reports (EIRs) for evaluation, as the districts complete reports covering inspections conducted during the last quarter of FY 2003.  As of October 2003, CFSAN has received 86 of the 104 foreign inspections reported in the field's FACTS database system.  Of the 86 EIRs received, CFSAN is currently reviewing 39, and the remaining 47 EIRs have been reviewed and given a final inspection classification.

Seafood Safety

34. Vibrio vulnificus Control Strategy: FDA continued to participate in the ISSC's Vibrio vulnificus Management Subcommittee to monitor the progress toward the illness reduction goals and to make modifications the Conference strategy as needed.  In particular, FDA and the subcommittee developed, and the full Conference adopted, procedures that processors would use to validate the effectiveness of post harvest treatment processes.  The goal was to have a uniform set of criteria that would be acceptable to all states, minimizing the burden on a processor that wished to begin such treatments, while ensuring the effectiveness of the process.

    Progress was also made on developing a mechanism to determine the level of post-harvest treatment capacity, necessary to verify whether one of the performance goals is met. FDA is aware of increased interest in post harvest treatment, as evidenced by the number requests by states for FDA evaluation of verification studies.  The ISSC education efforts have continued, including completion of a study to determine the baseline level of raw oyster consumer understanding of the Vibrio vulnificus issue.

35. Strategy for Seafood HACCP Compliance: In our strategy to increase above the level of 85% the number of seafood processors that are in compliance with the seafood HACCP program, CFSAN:
     
    • Continued prioritization in the compliance program of inspections of processors in industry sectors that lag behind in HACCP implementation and continued prioritization of inspections of processors that lack HACCP plans.
    • Issued to districts lists of the firms that still did not have HACCP plans to help the districts target inspections toward such firms.
    • Developed a research plan to develop a better understanding of what proper controls should look like in industry sectors that lag behind in HACCP implementation.
36. Guidance on the Use of the Term "Catfish": On December 6, 2002, announced in the Federal Register (67 FR 72691) the availability of document: titled: Guidance for Industry Implementation of Section 403(t) the Federal Food, Drug and Cosmetic Act(21 U.S.C 343(t) Regarding the Use of the Term "Catfish." Section 10806 of the Farm Security and Rural Investment Act of 2002 amends the Federal Food, Drug, and Cosmetic Act (the Act) to provide that a food shall be deemed to be misbranded if it purports to be or is represented as catfish, unless it is fish classified within the family Ictaluridae. The guidance document states that, consistent with the amendments to section 403 of the Act, importers, domestic distributors, and sellers of fish in interstate commerce bearing the term "catfish," that is not classified within the family Ictaluridae, may no longer use the term "catfish" on labeling, in whole or as part of their common or usual name. This guidance relates to all fish that are distributed in interstate commerce, including imports. A copy of the document can be found on the CFSAN Web site at:: http://www.cfsan.fda.gov/~frf/catfgui2.html
37. Mexican Molluscan Shellfish Program: Completed all technical assistance, training, program reviews, and on-site audits of the Mexican molluscan shellfish safety program to determine whether that program now provides adequate protection to U.S. consumer so that it may resume exporting to the United States. A memorandum of understanding with the Government of Mexico for raw molluscan shellfish was signed on June 18, 2003.  

Fresh Fruits and Vegetables

38. Mexican Government Certification Program for Cantaloupe Sold in the U.S.: FDA/CFSAN/ORA have been engaged throughout FY 2003 in assisting the Mexican Government with developing a certification program for cantaloupe sold in the U.S. The Mexican Government submitted its draft certification program to FDA in July. FDA's Cantaloupe Technical Team has since interacted regularly with the Mexican Cantaloupe Technical Team to provide comments and answer questions regarding multiple drafts of the certification program. This work is ongoing and will culminate with a MOU once FDA and Mexico have reached agreement on the terms of the certification program.

    CFSAN received 11 petitions for removal from Import Alert 22-01 since November 2002. Four of these firms have been successfully removed from the Import Alert after paper review of their operation and inspection of the firms. Two firms inspected earlier this year are in the process or providing assurance that the corrections promised by the firm are implemented and verified by SAGARPA/SENASICA. The remaining are in various stages of review.

39. Guidance on the Transport of Concentrated Juices: On April 24, 2003, announced in the Federal Register (67 FR 62488) the availability of the Guidance for Industry titled: Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices. The purpose of the guidance is to provide industry with FDA's recommendations for appropriate control measures to use in the bulk transport of juice concentrates and certain shelf stable juices. A copy of the guidance can be found on our website at: http://www.cfsan.fda.gov/~dms/juicgui8.html
40. Small Entities Guide for Juice HACCP: On April 4, 2003, announced in the Federal Register (68 FR 16541) the availability of the small entity compliance guide (SECG) for a final rule published in the Federal Register of January 19, 2001, entitled "Hazard Analysis and Critical Control Point (HACCP, Procedures for the Safe and Sanitary Processing and Importing of Juice."). The SECG, entitled "Juice HACCP," is intended to set forth in plain language the requirements of the final rule and to help small businesses understand the regulation. A copy of the guidance can be found on our website at: http://www.cfsan.fda.gov/~dms/juicgui7.html
41. Juice HACCP Training Curriculum: On June 13, 2003, published in the Federal Register (68 FR 35420) the availability of the final guidance entitled: Guidance to Industry: Standardized training Curriculum for Application of Hazard Analysis Critical Control Point Principles to Juice Processing. The guidance advises juice processors of FDA's view that the 1^st Edition of the Juice Hazard Analysis Critical Control Point (HACCP) training Curriculum of the Juice HACCP Alliance (the standardized curriculum) is adequate for use in training individuals to meet the requirements o the juice HACCP regulation.
42. Report to Congress - Juice Labeling: On May 14, 2003, submitted a report to Congress (House Report 107-623) clarifying that current regulations for the labeling of juices would prevent products that contained 5 percent or less of juice from being named "orange juice."  FDA believes that no new labeling guidelines are warranted.
43. Strategy for addressing the multiple outbreaks of E coli 0157:H7: CFSAN developed a strategy for addressing the multiple outbreaks of E. coli 0157:H7 from contaminated lettuce. The strategy calls for working with industry to collect specific information to fill in gaps such as using a questionnaire on lettuce-specific practices to see if any patterns emerge. The strategy also includes research, both basic and applied. Based on information gained, the strategy calls for identifying interventions to avoid or minimize contamination in the field or packing houses, to treat lettuce post-harvest, and education/outreach relative to safer production practices. Some of these actions have already been initiated.
44. International Good Agriculture Practices (GAP) Outreach in Conjunction with the Joint Institute for Food Safety and Applied Nutrition (JIFSAN): The U.S. Food and Drug Administration (FDA) and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) conducted a train-the-trainer program on Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) for the production of fresh produce from September 12 - 20, 2003 at the Cummunidad Andina in Lima, Peru. Participants included selected growers, state and federal officials, and consultants from the Andean region (Peru, Venezuela, Equador, Bolivia, and Columbia). Participants were trained in good agricultural and manufacturing practices. The course consisted of lectures, case studies, and practical exercises. An overview of FDA's registration, recordkeeping, and prior notice proposed rules implementing the Bioterrorism Act of 2002 was also presented. Participants took part in an extensive, commodity specific, farm exercise based on conditions realistic for the region. An examination, administered on the last day, resulted in a class average of 92%.

Listeria

45. Listeria Risk Assessment: On October 24, 3003, published in the Federal Register (68 FR 61006) a notice announcing the availability of a quantitative risk assessment on the relationship between foodborne Listeria monocytogenes and human health that considers 23 ready-to-eat food categories. The document is entitled: "Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes among Selected Categories of Ready-to-Eat-Foods." The risk assessment has been revised in response to the public comments, newly available data, and updated modeling techniques.

Cooperative Programs

46. Food Code Adoption: At the end of FY 2003, Forty-two States and territories have adopted codes patterned after either the 1993, '95,'97,'99 or 2001 versions of the Food Code. Those 42 states and territories represent 76% of the U.S. population. This meets our goal for FY 2003.

Chemical Contaminants, Pesticides and other Hazards

47. Acrylamide Action Plan: FDA completed the development phase of its action plan by presenting and receiving advice on the plan from FDA's Food Advisory Committee and the Contaminants and Natural Toxicants Subcommittee of the Food Advisory Committee. Implementation of this action plan has begun by completing the preliminary or exploratory survey on acrylamide occurrence in foods and acrylamide analyses of FDA's FY/03 Total Diet Study Survey food samples.  Major studies on acrylamide formation in foods and on toxicology and health effects, as outlined in the action plan, are underway at FDA, CDC, and NIH.
48. Food Advisory Committee Meeting on Acrylamide: On February 24-25, 2003, convened the FDA Food Advisory Committee to consider findings reported from Sweden in the Spring of 2002 on acrylamide levels in food. The committee reviewed the FDA draft Action Plan concerning acrylamide with the objective of determining risks and reducing levels of acrylamide in foods as quickly as possible.
49. Total Diet Survey and Acrylamide Field Assignment: On December 12, 2002, issued in conjunction with FDA's Office of Regulatory Affairs, a field assignment to analyze Total Diet Survey samples and other specific food samplers for acrylamide.
50. Chloramphenicol: During the latter part of FY 2002 and all of FY 2003, FDA collected for the detection level of chloramphenicol samples of Shrimp, Crabmeat, Crayfish and Honey. (1) Shrimp (of 315 samples, 46 tested positive for chloramphenicol), (2) Crabmeat (of 14 samples, 6 tested positive for chloramphenicol), (3) Crayfish (of 8 samples, 0 tested positive for chloramphenicol), and (4) honey (of 50 samples, 36 tested positive for chloramphenicol).
51. Generic "Channels of Trade" Guidance: On July 22, 2003, announced in the Federal Register (68 FR 43535) the availability of a level 1 draft 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" (EPA). This guidance is intended to present general policy on FDA's planned enforcement approach for foods containing such residues in accordance with the provision in section 408(1)(5) (the "channels of trade provision") of the Federal Food and Drug and Cosmetics Act (FFDCA), as amended by the Food Quality Protection Act (FQPA).
52. Revised Compliance Policy Guide on Radionuclides in Foods: FDA will soon publish in the Federal Register a draft Compliance Policy Guide entitled: "Guidance Levels for Radionuclides in Domestic and Imported Foods," Availability and Draft Supporting Document; "Supporting Document for Guidance Levels for Radionuclides in Domestic and Imported Foods." The draft CPG would will rescind and replace the current CPG Sec. 560.750 Radionuclides in Imported Foods - Levels of Concern (CPG 7119.14). It will provide updated guidance levels for radionuclide activity concentration in food offered for import and make these same guidance levels for radionuclide activity concentration applicable to food in domestic interstate commerce for the first time.
53. Food Samples for Pesticides and Chemical Contaminants: In FY 2003, FDA collected and analyzed 11,331 food samples for pesticides and chemical contaminants. Our goal was to complete 8000 samples by the end of FY 2003. FDA exceeded its goal by 3,331 at 142% of our intended target.
54. Implementation of FDA's Dioxin Strategy: CFSAN's Dioxin Monitoring Program requested collection of approximately 1500 food and feed/feed component samples for dioxin analysis in FY 2003. Samples included dairy products, eggs, fruits/vegetables, grains/cereals, fats/oils, aquaculture and wild finfish, tree nuts, feed/feed components and Total Diet Study samples.

    CFSAN initiated two follow-up investigations for aquaculture catfish feed and feed components and shell egg samples. Aquaculture catfish feed and feed component follow-up investigation identified a mineral feed components found to contain elevated levels of dioxin. The mineral feed component and mineral premix containing the contaminated mineral feed component were recalled by the manufacturers.

    CFSAN published a Laboratory Information Bulletin (LIB) addressing methods for the analysis of 3 dioxin-like PCB congeners. These 3 PCB congeners have been included in CFSAN's Dioxin Monitoring Program. CFSAN is drafting an additional LIB which includes 5 other dioxin-like PCBs and 18 non-coplanar PCBs which will also be included in the Dioxin Monitoring Program.

    CFSAN participated in the interagency (USDA, EPA, FDA) oversight committees as part of USDA's Food Safety and Inspection Service (FSIS) development of its Dioxin Survey Follow-up Plan.

55. Proposed Rule/Direct Final Rule - Radionuclides for Bottled Water: On March 3, 2003, published in the Federal Register (68 FR 9955) a proposed rule and direct final rule (68 FR 9873) for radionuclides quality standards for bottle water. This final rule will ensure that the minimum quality of bottled water, as affected by uranium, combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards.

    On June 9, 2003, published in the Federal Register (FR 68 34272) confirmation of effective date of December 8, 2003 for the direct final. This document confirms the final rule.

56. Perchlorate - Initiate development of an analytical method to detect Perchlorate in produce, so that FDA can conduct effective monitoring: Two methods have been developed for the determination of perchlorate in lettuce and in bottled water. The first method uses liquid chromatography with mass spectrometry detection and has an estimated limit of quantitation of 1 µg/kg in lettuce and 0.5 µg/L in bottled water. This method has been sent to an FDA field laboratory for testing and comment. The second method uses ion chromatography with electro-conductivity detection and has an estimated limit of quantitation of 20 µg/kg in lettuce and 1 µg/L in bottled water. The method is being drafted and an FDA field lab will be asked to test and comment on the method.

Transmissible Spongiform Encephalopathies (TSEs)

57. Respond Effectively, working with APHIS and FSIS, to the Occurrence of BSE in Canada: FDA continues work with both USDA's APHIS and FSIS to respond to the BSE situation in Canada. For approximately a month after the May discovery of a cow in Canada with BSE, FDA and USDA had daily interagency phone calls to coordinate response to the situation. When the daily calls were no longer considered necessary, the agencies agreed to continue to communicate as needed to ensure that we respond as one government to the Canadian situation. FDA is currently in discussions with APHIS about what would be needed to allow import of additional bovine commodities from Canada.

Food Allergens

58. Food Allergen Outreach: CFSAN participated as speaker in more than 22 industry, consumer and regulatory conferences. These conferences were given to discuss FDA food allergen plans with the food industry and consumers on the topic of the presence of allergens in foods.
59. AOAC Evaluation of Peanut Protein Test Kits: On May 3, 2003, completed the Association of Official Analytical Chemists (AOAC) multi-laboratory performance validation of commercially available immunochemical peanut protein test kits. This performance validation provides an interim analytical method that can be used for regulatory enforcement and to monitor for the presence of peanut proteins (allergens) in multiple food matrices.
60. Advisory Committee Meeting on Latex Allergenicity Issues: On August 26^th and 27^th, CFSAN convened a meeting of the Additives and Ingredients Subcommittee of its Food Advisory Committee to assist in gathering information, and to get independent expert consideration of questions that have been raised regarding natural rubber latex (NRL) allergy as it relates to food safety. Natural rubber is an approved indirect food additive when used as a component of a repeat-use, food-contact article such as a food-service glove. Nevertheless, FDA has received reports of latex allergic individuals exhibiting allergic reactions to foods believed to have been prepared by workers wearing NRL food-service gloves.

    During the two day meeting, the Subcommittee also heard from CFSAN staff together with a variety of other sources, including experts from FDA's Center for Devices and Radiological Health (CDRH) and FDA's Center for Biologics Evaluation and Research (CBER), as well as experts from outside of FDA. The Subcommittee reached a consensus that a potential hazard may exist, but concluded that the science establishing a risk from the use of NRL food-service gloves is very weak. The subcommittee recommended that FDA consider certain specifications for food service gloves (for example, residual protein and donning powder levels) to address the potential hazard, and that well-designed clinical studies would be helpful to better understand the levels of exposure that would be required to elicit a systemic response in a latex allergic individual.

61. FY 2002 Food Allergens Inspections: CFSAN created an Allergen Inspection Database. FY 2002 Establishment Inspection Reports (EIR's) have been coded and entered into the database. CFSAN successfully completed the evaluation and summarization of the data from 500 allergen inspections conducted in FY 2002.

Education

62. Food Safety and Security Meetings in South America: Three-hundred representatives from 10 nations in South America participated in an FDA sponsored regional outreach meeting on food safety and security that was held in Buenos Aires, Argentina on September 1 and 3. The interagency U.S. delegation consisted of representatives from FDA, USDA's Food Safety and Inspection Services (FSIS), the Centers for Disease Control and Prevention (CDC), and Department of Homeland Security/Customs Border and Protection (CBP). The program consisted of presentations on U.S. food safety and security programs, U.S. import requirements, and concurrent sessions on regulations and guidance for specific commodities (including produce, seafood, juice, dairy and egg products, meat and poultry. The delegation hosted a press conference to discuss the meeting and to report progress on the implementation of the Bioterrorism Act. The delegation participated in a field trip to a food distribution warehouse in Buenos Aires, and a dairy processing plant outside the city. A regional dairy processing safety program was held in Montevideo, Uruguay immediately following the meeting in Argentina. Trainers included representatives from CFSAN, FDA's Center for Veterinary Medicine (CVM), and FDA's Office of Regulatory Affairs (ORA). In addition to a review of how dairy products are regulated in the United States and a review of best practices, the trainers provided an update on the progress of the new Bioterrorism regulations. Over 150 representatives from 10 nations participated. The response to both meetings was overwhelmingly positive.
63. Vibrio vulnificus Education and Outreach: FDA launched a public education campaign targeted to Hispanic men on the risks from Vibrio vulnificus in raw oysters in the summer of 2003. Facets of the campaign included a partnership with community-based health organizations and outreach through the Hispanic media. FDA provided information in the form of a fotonovela (illustrated storybook that shows what may happen if people with weakened immune systems eat raw oysters contaminated with Vibrio vulnificus) and by distributing public service announcements. This Education Campaign was carried-out through Hispanic media nationwide (i.e., news paper, radio, and television) with special emphasis in Florida and Texas media. This effort reached an audience of over 3 million people.

Part II: Assuring Food & Cosmetic Safety & Improving Nutrition: Specific Program Areas

Food and Color Additives - Premarket Review

64. Food and Color Additive Petitions - Expedited Review: For the petition receipt cohort of FY 2002, completed within 360 days of filing, the safety evaluation of three of the three (100%) food additive petitions that qualify for expedited review. A petition qualifies for expedited review if the food additive is intended to decrease the incidence of foodborne illnesses through its antimicrobial actions against human pathogens that may be present in food.
65. Food and Color Additive Petitions - Non-expedited Review: For the petition receipt cohort of FY 2002, completed within 360 days of filing, the safety evaluation of six of the eight (75%) food and color additive petitions that do not qualify for expedited review. This meets our goal of completing at least 70% of these petitions within 360 day.
66. Overdue Food and Color Petitions: CFSAN took action on 5 of 13 food and color additive petitions that were under review for more than 360 days at the beginning of FY 2001. This meets our goal to essentially eliminate the inventory of overdue food and color additive petitions by reducing to fewer than 10 the number of food and color additive petitions that were received prior to 10/1/2001.
67. Biotechnology Consultations: Completed the evaluation of all (3) biotechnology final consultations received in FY 2002.
68. GRAS Notifications: Completed processing of 28 of 30 (93%) GRAS Notifications received in FY 2002 within 180 days. This exceeds our goal of completing atleast 80% of GRN's within 180-day statutory timeframe.
69. Food Contact Notifications: Completed review of all 111 Food Contact Notifications within 120-day statutory timeframe.
70. Food Contact Substances Annual Cost-estimate: CFSAN drafted a Report to the Appropriations Committee that provides an estimate of the costs of carrying out the premarket notification program. The report is currently going through Administration clearance.
71. Reauthorization of the Food Contact Notification Program: In conjunction with FDA's Office of the Chief and Counsel and the Office of Legislation, rendered legal opinion to document that the funding of the Food Contact Substances Notification Program becomes part of FDA's permanent appropriation beyond FY 2003.

Nutrition, Health Claims and Labeling

72. Publish Guidance Extending Qualified Health Claims To Conventional Foods: On December 20, 2002, published Guidance for Industry titled: "Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements." This document updates the Agency's approach to implementing the court of appeals decision in Pearson v. Shalala (Pearson) to include conventional foods and provides guidance to industry on the circumstances under which FDA will consider exercising its enforcement discretion for health claims that do not meet the "significant scientific agreement" standard of evidence.

    The document also clarified that the Agency will use the "reasonable consumer" standard in evaluating food labeling claims. A copy of the guidance can be found on our Web site at: http://www.cfsan.fda.gov/~dms/hclmgui2.html

73. Establishment of the Task Force on Consumer Health Information and Better Nutrition: On January 15, 2003, the FDA Task Force on Consumer Health Information for Better Nutrition was established. The Task Force has been charged to provide recommendations to develop new procedures for the review of qualified health claims and to propose a consumer studies research agenda within 6 months. On March 13, 2003, the Task Force established a public docket (03N-0069) to receive views and comments from interested stakeholders. The comment period closed May 27, 2003.
74. Issue Scientific Guidances on "Qualified Health Claims": On July 10, 2003, the FDA Task Force on Consumer Health Information for Better Nutrition issued its report. Attachment B to that Report is a guidance document entitled "Interim Evidence-based Ranking System for Scientific Data." A Notice of Availability about FDA's guidance on qualified health claims published in the Federal Register on July 11, 2003. Both the notice and the guidance itself are available online at: http://www.fda.gov/ohrms/dockets/default.htm.
75. Develop Procedures for Timely Review of Qualified Health Claim Petitions: On July 10, 2003, the FDA Task Force on Consumer Health Information for Better Nutrition issued its report. Attachment E of that report entitled, "Interim Procedures for Qualified Health Claims in the Labeling of Conventional food and Human Dietary Supplements." It sets for the procedures FDA will use for the timely review of qualified health petitions, beginning September 1, 2003. These procedures are intended to be interim until such time as notice-and-comment rulemaking for a qualified health claim petition regulatory framework is completed. A copy can be found on the CFSAN Web site at: http://www.cfsan.fda.gov/~dms/hclmgui3.html. An internal assessment of staffing needs for this process was completed.
76. Develop Framework For Proposed Regulation Governing Qualified Health Claim Petitions: On July 10, 2003, the FDA Task Force on Consumer Health Information for Better Nutrition issued its report. Attachment A of that report entitled "Possible Regulatory Framework for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements" presents a framework for proposed regulation of qualified health claims. This document developed three regulatory alternatives for consideration and comment. A copy of this document can be found on the CFSAN Web site at:http://www.cfsan.fda.gov/~dms/nuttf-a.html
77. Develop Consumer Research Agenda: On July 10, 2003, the FDA Task Force on Consumer Health Information for Better Nutrition issued its report. Attachment D of that report entitled "Consumer Studies Research Agenda - Improving Consumer Understanding and Product Competition on the Health Consequences of Dietary Choices" presents a description of proposed consumer research studies and a timeline for peer review of the protocol as well as OMB approval. A timeline also has been prepared to show the activities following OMB approval, including estimated time to conduct and evaluate the studies. This document can be found on the CFSAN Web site at: http://www.cfsan.fda.gov/~dms/nuttf-d.html.
78. Infant Formula Premarket Notifications: Completed the review of fifty-four premarket notifications for new infant formulas with objections given for only one. All were completed within the statutory timeframe.
79. Nutrient Content/Health Claims Petitions: During FY2003 CFSAN reviewed and issued decisions on 10 nutrient content and health claim petitions. Of these, four claims were denied, regulations were published for two claims (amending 21 CFR 101.80 and 21 CFR 101.81), and four other claims were permitted as qualified health claims by exercise of enforcement discretion.
80. Report to Congress on Omega-3 and Salmon: House Report 107-623 of the Agriculture, Rural Development, Food and Drug Administration and Related Agencies 2003 Appropriations Language directed FDA to consider the health claim that "consumption of omega-3 fatty acids in salmon can prevent and reverse heart disease." FDA prepared a report to Congress explaining the Agency's initiative to make available to consumers more and better information about the health benefits of foods and dietary supplements. This initiative will include consideration of a qualified health claim on omega-3 fatty acids for conventional foods such as salmon. This Report to Congress was transmitted to Congress on June 16, 2003.
81. Trans Fat Final Rule: On July 11, 2003, FDA published in the Federal Register (68 FR 41434) final regulations to require that Trans fat will be listed on Nutrition Facts panels.  The additional information will give consumers a more complete picture of fat content in foods -- allowing them to choose foods low in saturated fat, trans fat and cholesterol, all of which raise LDL ("bad") cholesterol which is associated with an increased risk of coronary heart disease.
82. ANPR the Footnote of the Trans fat Final Rule: On July 11, 2003, FDA simultaneously issued an advance notice of proposed rulemaking (ANPRM) in the Federal Register (68 FR 41507) to solicit information and data that could be used to establish new nutrient content claims about trans fat. The ANPRM also solicited information and dates to establish qualifying criteria for trans fat in existing claims that have a limit on saturated fat and health claims that contain a message about cholesterol-raising lipids.  The ANPRM requests comment on whether we should consider statements as footnotes in the Nutrition Facts panel or in conjunction with claims to enhance consumers' understanding about how to use the information to make heart-healthy food choices.
83. Sodium Provision for the Nutrient/Content Claim "Healthy": On February 20, 2003, published in the Federal Register (68 FR 8163) a proposed rule to amend the regulation for sodium levels for foods that use the nutrient content claim "healthy." The proposal establishes sodium levels for the definition of "healthy" that are not so restrictive as to preclude the use of the term "healthy," and not so broadly defined as to cause the term to lose its value in identifying useful products for constructing a healthful diet. The Agency based the proposed sodium requirements on the presumption they represent levels that are achievable by manufacturers, but sufficiently restrictive to provide consumers with a meaningful definition of the term "healthy" that will asses them in constructing a diet consistent with dietary guidelines.
84. Infant Formula GMPs: On April 28, 2003, published in the Federal Register (68 FR 22341) a proposed rule to reopen the comment period for the proposed rule, published in the Federal Register of July 9, 1996 (61 FR 36154), revising its infant formula regulations in 21 CFR parts 106 and 107. The proposed rule would establish requirements for current good manufacturing practice (CGMP) and audits, establish requirements for quality factors, and amend its quality control procedures, notifications, and records and report requirements for infant formula. FDA is reopening the comment period to update comments and to receive any new information.
85. Infant Formula Advisory Committee Meeting: On November 18-19, 2003, convened the Infant Formula Subcommittee of the Food Advisory Committee. The meeting's purpose was to discuss the scientific issues and principles involved in assessing and evaluating whether a "new" infant formula supports normal physical growth infants when consumed as a sole source of nutrition.

    This was the second meeting of a series of advisory committee meetings to discuss the scientific issues involved in evaluating whether a new infant formula supports normal physical growth. Transcript and other specific information about this advisory committee meeting can be found on our Web site at: http://www.fda.gov/ohrms/dockets/ac/cfsan02.htm

86. Advisory Committee Meeting - Enterobacter sakazakii: On March 18-19, 2003, convened the Contaminants and Natural Toxicants Subcommittee of the FDA Food Advisory Committee. The purpose of the meeting was to discuss the scientific issues and principles involved in assessing and evaluating Enterobacter sakazakii contamination in powdered infant formula, risk reduction strategies based on available data, and research questions and priorities. The proceedings can be found at our Web site at: http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3939t1.htm
87. Food Advisory Committee on Nutrition: The Nutrition Subcommittee of the Food Advisory Committee was constituted in September, 2003. There are six professional members and a Consumer Representative serving on the subcommittee. The Industry Representative selection will be announced in the near future. The date of the first meeting determined in FY 2004.
88. Enforcement Activities: During FY 2003, FDA/CFSAN's Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) has reviewed a total of 75 domestic and import Warning Letter and Detention recommendations, and 2 seizure recommendations.  Four of the Warning Letters were issued directly from CFSAN, and they dealt with issues related to unauthorized nutrient content claims, health claims, and structure/function claims on conventional foods and other food product categories.

Dietary Supplements

89. 75-Day Premarket Notification of New Dietary Supplement Ingredients: During FY 2003, CFSAN filed and responded to 58 notifications for dietary supplements containing new dietary ingredients. All within the 75 day period. The notifications are reviewed for science-based evidence of safety. Letters are issued to the notifier to acknowledge receipt and, when necessary, to identify deficiencies and safety concerns.
90. Dietary Supplements GMPs: On March 13, 2003, published in the Federal Register (68 FR 12157) a proposed rule on Current Good Manufacturing Practice (CGMP's) in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements. The proposed rule would establish the minimum CGMP's necessary to ensure that, if a company engages in activities related to manufacturing, packaging, or holding dietary ingredients or dietary supplements, that company does so in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements.

    The provisions would require manufacturers to ensure the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. A copy of the proposal is available on our Web site at: http://www.cfsan.fda.gov/~lrd/fr030313.html

91. Dietary Supplements - Outreach Activities: FDA/CFSAN held two stakeholders meeting to discuss the proposed regulations on Current Good Manufacturing Practices (GMPs) for dietary supplements and ingredients. The first meeting was held at the CFSAN Wiley Building in College Park on April 29, 2003, and the second meeting was held in Anaheim, Ca on May 6, 2003. As many as 86 stakeholders from industry, industry trade organizations, legal firms and other dietary supplement related organizations attended these meetings. A satellite broadcast on dietary supplement GMPs for stakeholders was held on May 9, 2003.
92. Dietary Supplement Advisory Committee Meeting: On March 25, 2003, convened the Dietary Supplement Subcommittee of the FDA Food Advisory Committee. The purpose of this meeting was to explore whether there are recognized scientific principles that would facilitate reaching a conclusion as to whether a particular substance is a "metabolite" of another substance that is a dietary ingredient within the scope of section 201(ff) (1) of the Federal Food, Drug, and Cosmetic Act (the act). Specific briefing information on this meeting can be found on our web site at: http://www.fda.gov/ohrms/dockets/ac/03/briefing/3942b1.htm
93. Common or Usual Botanical Names Used in Dietary Supplements: FDA published a proposed and a companion direct final rule in the Federal Register on August 28, 2003, entitled "Food Labeling:  Ingredient Labeling of Dietary Supplements That Contain Botanicals." If no significant adverse comments are received in response to either rule, FDA intends to publish a document in the Federal Register to confirm the January 1, 2006, effective date of the final rule.  The proposed rule and direct final rule are substantively identical.  FDA is amending its regulation on declaring botanical ingredients in dietary supplements to incorporate by reference the 2000 editions of Herbs of Commerce and the International Code of Botanical Nomenclature (Saint Louis Code).
94. Strategy for Dietary Supplements containing Ephedra/Ephedrine: On February 28, 2003, HHS and FDA announced a series of actions designed to protect Americans from the potentially serious risks of dietary supplement products containing ephedra/ephedrine. Among these actions, FDA proposed a new warning label for all ephedra-containing dietary supplements. FDA relied heavily on the results of the RAND Corporation study. Additional information and materials about the risk of ephedra and ephedrine, including the full RAND report, can be found on FDA's Website at the following addresses: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00875.html. In seeking comments on the new warning label and other issues, FDA reopened a proposed rule entitled: "Dietary Supplements Containing Ephedrine Alkaloids. " The comment period of the proposed rule has ended and comments are currently under review. Once all comments have been analyzed, the most appropriate approach to reducing the risk of using dietary supplement products containing ephedrine alkaloids will be determined.
95. Dietary Supplement Labeling Guide: FDA developed a comprehensive labeling guide for dietary supplements which is undergoing CFSAN clearance and will soon be placed on CFSAN's web site. The guide, like FDA's food labeling guide for conventional food labeling, is a plain language, question and answer format summary of major labeling requirements for dietary supplements. It also addresses some frequently asked questions and is primarily intended to help small businesses understand and follow the current labeling requirements for dietary supplements.
96. Safety Problems Associated with Dietary Supplements: In FY 2003 CFSAN published information on dietary supplements or ingredients that have raised safety concerns. CFSAN continues to identify and investigate these and other dietary supplements that raise potential safety issues, and to consider appropriate regulatory follow-up.
97. Unsubstantiated claims on Dietary Supplements: On December 18, 2002, FDA announced a significant enforcement initiative targeted at misleading claims about dietary supplement-associated health benefits. Over the last six months, the FDA issued 73 warning letters and cyber letters to marketers of dietary supplement products; seized products worth almost $9 million; refused import of 368 shipments of dietary supplement products offered for entry; and supervised the voluntary destruction of $515, 000 worth of dietary supplements promoted with unsubstantiated structure/function claims. The Dietary Supplement Enforcement Report can be found on our Web site at: http://www.fda.gov/oc/whitepapers/chbn_summary.html

    With the mutual goal of consumer protection, FDA and FTC formed a Dietary Supplement Enforcement Working Group to closely coordinate their enforcement efforts against health care fraud. In addition, FDA and FTC chair an interagency health fraud steering committee that meets regularly to coordinate activity on these issues. The workgroup currently includes federal agencies in the U.S. and Canada. Mexico has been invited to join the group.

Cosmetics

98. Certified Color Additives: Met FDA's goal by analyzing all batches of color additives and determined certification status (i.e., certify or refuse to certify) within an average of 5 working days.
99. Draft Guidance - Alpha Hydroxy Acids: On December 2, 2002, announced in the Federal Register (67 FR 71577) the availability of a draft guidance document entitled "Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients." This draft guidance is intended to provide the cosmetic industry with suggested wording for a label statement alerting consumers to the possibility of increased skin sensitivity, particularly sunburn, associated with the use of such products, as well as protective measures to use.
100. Revitalization of the FDA's Cosmetics Program: CFSAN's Office of Cosmetics and Colors (OCAC) met with stakeholders to achieve their input on how to revitalize the FDA's Cosmetics Program. As a result of these meetings, OCAC has developed priority activities that will be highlighted and implemented in CFSAN's FY 2004 Program Priorities, to issue later this year.
101. Voluntary Cosmetic Registration Program (VCRP): Developed a WEB-based, online, interactive registration system with which manufacturers, repackers and distributors of cosmetic products can register their cosmetic formulations. The system also will allow industry to update and/or discontinue old formulations.
102. Move Activities of the Office of Colors and Cosmetics: FDA/CFSAN's Office of Cosmetics and Colors successfully relocated its offices and laboratories to their temporary operating locations at Chantilly, VA., Vermont Avenue, NW (Wash DC); the BRF building in Beltsville, MD; and the College Park facility. The relocations took place with no down time for the Color Certification Program and minimal disruption of the Cosmetics Program.
103. Memorandum of Understanding between CFSAN and CDER: On May 16, 2003, updated and finalized an inter-center agreement between FDA's Center for Drug Evaluation and Research (CDER) and the Center for Food Safety and Applied Nutrition (CFSAN) to assist FDA in implementing the drug and cosmetic provisions of the Federal Food, Drug and Cosmetic Act for products that purport to be cosmetics but meet the statutory definition of a drug. This three-year memorandum of understanding, which took effect June 1, 2003, supersedes the pre-existing agreement, which expired May 31, 2003.

Part III: Assuring Safety: Crosscutting Areas

Science Base

104. Food Advisory Committee Appointments: In September 2003, FDA issued appointment letters to members of the FDA Food Advisory Committee and the Subcommittee on Nutrition.
105. FY 2003 Food Advisory Committee Meetings: In FY 2003, the FDA convened one meeting of the Full Food Advisory Committee and six meetings of the subcommittees of the FAC.
     • Full Committee - February 24-25, 2003
     • Infant Formula Subcommittee - November 4 - 5, 2002
     • Contaminants and Natural Toxicants Subcommittee - December 4-5, 2002
     • Contaminants and Natural Toxicants Subcommittee - March 18-19, 2003
     • Dietary Supplements Subcommittee - March 25, 2003
     • Additives and Ingredients Subcommittee - August 26-27, 2003
     • Food Biotechnology Subcommittee - September 24, 2003
106. Report to Congress on "Pet Turtles": On June 16, 2003, submitted a report to Congress describing FDA current regulations on intrastate and interstate requirements for Pet Turtles, in response to the FY 2003 Omnibus Appropriations Bill P.L. 108-7, enacted 2/20/03.
107. Cooperative Agreement between FDA and the University of Mississippi: On September 9, 2003, issued notice of grant award (for FY 2004 budget period) to continue the five-year cooperative research agreement between CFSAN/FDA and the University of Mississippi's National Center for Natural Products Research.
108. Evaluation of the JIFSAN Program: In December 2002, FDA/CFSAN completed an annual report evaluating JIFSAN's program and adherence to the 1996/7 Memorandum of Understanding with University of Maryland at College Park, including recommendations and implementation plan. A copy of the report can be found at the JIFSAN Web site at: http://www.jifsan.umd.edu/annualrep.htm

     JIFSAN has agreed to provide support to the Center for Risk Communication Research (CRCR) within the University of Maryland's Department of Communication. Several FDA staff from CFSAN will be working with Director of this new Center as members of an interim working group to help develop a strategic plan for the CRCR including a discussion on what are the research questions that both parties (UM and CFSAN) are interested in addressing.

109. Continued the food processing and packaging research and outreach programs at the National Center for Food Safety and Technology (Moffett Center), with a focus on contemporary food safety and security issues. The application for the cooperative agreement supporting NCFST has been received from IIT, reviewed, approved, and the funding provided. NCFST is significantly expanding its research program through the development of a BSL-3 level laboratory and conduct of critical research to enhance food security, particularly in assessing food technologies that can reduce this risk.
110. "Monkey Pox:" FDA in conjunction with the Centers for Disease Control and Prevention (CDC) are in the final drafting stages of completing an interim final rule that will codify interstate/intrastate transportation and importation of animals and high-risk animal derived products contaminated with monkey pox. Within FDA, major responsibility on this issue will shift to FDA's Center for Veterinary Medicine (CVM) in conjunction with the Office of Regulatory Affairs (ORA).

International

111. 25^th Session of the Codex Alimentarius commission: Attended, on behalf of FDA, the 25th Session of the Codex Alimentarius Commission, held February 13-15, 2003, in Geneva, Switzerland. The purpose of the Session was to discuss the Report of the Joint FAO/WHO Evaluation of the Codex Alimentarius and other FAO and WHO Work on Food Standards. The Commission agreed upon a statement on the outcome of the evaluation. This statement will be submitted to the Governing Bodies of WHO and FAO for further consideration. A copy of the report can be found at: http://www.who.int/fsf/Codex/Codex_Evaluation_Final_Report _en.pdf
112. 26^th Session of the Codex Alimentarius commission: Provided the Alternate U.S. Delegate and other leadership, on behalf of FDA, at the 26th Session of the Codex Alimentarius Commission, held June 30 - July 7 in Rome, Italy. The purpose of the Session was to adopt standards recommended by the various Codex Committees and Task Forces, elect a new Chairperson and Vice-Chairpersons of the Commission and further consider the results of the Codex Evaluation.

     The Commission adopted 58 standards of which several (pesticide residue and veterinary drug maximum residue limits, food additive maximum limits) were composite standards consisting of multiple individuals standards, Key standards adopted with respect to FDA included those for the food safety assessment of foods derived from genetically modified plants and foods derived from genetically modified microorganisms, various food additive permitted usages, the Code of Hygienic Practice for Fresh Fruits and Vegetables, a revision to the General Standard for Irradiated Foods and Guidelines for the Judgment of Equivalence of Sanitary Measures Associated with Food Import and Export Inspection and Certification Systems. Many key decisions were made regarding the Evaluation of Codex and related WHO/FAO activities including: agreeing that mandate of Codex (protection of consumer health and the fair practices in fair trade) should remain unchanged; agreeing in principle to annual sessions of the Commission; strengthening the role of the Executive Committee and enhancing the transparency of its work; expediting the development and adoption of standards including implementing a critical review process and timeframes for work on standards, revising the criteria for new work and developing guidelines for Codex Chairpersons, host governments, and for electronic and physical working groups. Elected Chairperson of the Codex Alimentarius Commission was Dr. Stewart Slorach of Sweden. Elected Vice-Chairpersons of the Commission were Dr. Paul Mayers, Canada, Dr. Claude Moshe, United Republic of Tanzania, and Dr. Hiroshi Yoshikura of Japan.

113. Codex Committee on Nutrition and Foods for Special Dietary Uses: Led U.S. Delegation to the 24^th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses in Berlin, Germany, on November 4-8, 2002. The Committee spent a considerable amount of time discussing the Scope of two Proposed Draft Revised Standards: (1) Proposed Draft Revised Standard for Infant Formula and (2) Proposed Draft Revised Standard for Processed Cereal-Based Foods for Infants and Young Children. The Committee was able to hold only limited discussion on the Draft Guidelines on Vitamin and Mineral Food Supplements. The Delegation of Germany presented a revision to the Advisory List(s) of Mineral Salts and Vitamin Compounds for the Use in Foods for Infants and Young Children in view of the comments provided. The Committee decided to keep the Advisory List at step 2/3 for redrafting, comments and further discussion at the next session.
114. Codex Committee on Import and Export Inspections and Certification Systems: Led U.S. Delegation to the 11^th Session of the Codex Committee on Import and Export Inspections and Certification Systems (CCFICS), December 2-6, 2002, in Adelaide, Australia. Most notably the CCFICS completed work on the Draft Guidelines on the Judgment of Equivalence of Sanitary Measures Associated with Food Import and Export Inspection and Certification Systems. The Committee also agreed to continue work on traceablilty/product tracing. Also at this 11^th Session of the CCFICS, the committee continued work on the following documents: (1) Proposed Draft Guidelines for Exchange of Information in Food Control Emergency Situations; (2) Proposed Guidelines for the Judgment of Equivalence of Technical Regulations Associated with Food Import and Export Inspection and Certification Systems; and discontinued work on Proposed Draft Guidelines for the Utilization and Promotion of Quality Assurance Systems to Meet Requirements in Relation to Food.
115. Codex Committee on Food Hygiene: Led U.S. Delegation to the Codex Committee on Food Hygiene (CCFH), January 27^th - February 1^st 2003, in Orlando, Florida. At this session, the CCFH advanced the Code of Hygienic Practice for Milk and Milk Products; approved for final adoption by Codex revisions of the Codex HACCP guidelines; approved new work to initiate revision to an old Code of Hygienic Practice for Foods for Infants and Children: this revision will take into account current concerns associated with the possible presence of Enterobacter sakazakii in Infant Formula; agreed to a revised approach to develop risk management guidance for Listeria monocytogenes and to work towards the development of risk management guidance for several other foodborne pathogens including Salmonella, Campylobacter, Vibrio parahaemolyticus and enteropathogenic E.coli; and finally, the committee initiated a process to develop a long term approach and strategy to assigning priorities for its work, developing its Codex texts, and interacting with other Codex Committees.
116. Codex Committee on Food Additives and Contaminants: The 35^th Session of the Codex Committee on Food Additives and Contaminants (CCFAC) was held in Arusha, United Republic of Tanzania, on March 17-21, 2003. Due to travel restriction based on world events, the U.S. Delegation participated in the development of a number of the standards and codes of practice on the agenda but did not attend the meeting, and the only delegation from the western hemisphere in attendance was Brazil.

     The CCFAC forwarded the following standards and codes of practice for final adoption (Step 8) by the 26^th Session of the Codex Alimentarius Commission (CAC): (1) Revisions to the Annex to Table 3 of the Codex General Standard for Food Additives; (2) Revised Codex General Standard for Irradiated Foods; (3) Code of Practice for the Prevention and Reduction of Patulin Contamination in Apple Juice and Apple Juice Ingredients in other Beverages; (4) Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals, including Annexes on Ochratoxin A, Zearalenon, Fumonisns and Tricothecenes; (5) Revisions to the Codex International Numbering System (INS) for Food Additives; (6) Specifications for the Identity and Purity of Food Additives.

     The 35^th CCFAC also advanced the following documents for intermediate endorsement by the 26^th CAC: (1) Risk Analysis Principles Applied by the Codex Committee on Food Additives and Contaminants; (2) Revised Food Category System of the Codex General Standard for Food Additives; (3) Principles for Exposure Assessment of Contaminants and Toxins in Foods; (4) Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Peanuts; (5) Code of Practice for the Prevention and Reduction of Lead Contamination in Foods; (6) Maximum Levels for Cadmium.

117. Codex Committee on General Principles: Served on U.S Delegation to the Codex Committee on General Principles (CCGP), April 7-11, 2003, in Paris France. At this session, the CCGP recommended for adoption at Step 8 by the Codex Alimentarius Commission Working Principles for Risk Analysis in the Framework of Codex. This "Principles" document provides overarching guidance in the form of principles on the three elements of risk analysis (risk assessment, risk management, and risk communication) to Codex Committees, particularly those dealing with food hygiene, food additives and contaminants, pesticide residues and veterinary drugs. The Committee held at Step 2 for further discussion a companion document that provides guidance to countries on risk analysis. The Committee also agreed to undertake the development of a definition for product tracing/traceability and continued work on the revision to the Codex Code of Ethics for International Trade in Food. Additionally, the Committee recommended for adoption amendments to the Codex Procedural Manual that would allow full voting membership in Codex of "Regional Economic Integration Organizations" (e.g., the European Union) and continued discussion on how Codex might interact with other international intergovernmental organizations in the development of food safety and quality standards.
118. Codex Committee on Food Labeling: Led U.S. Delegation to the Codex Committee on Food Labeling (CCFL), April 28 - May 2, 2003, Ottawa, Canada. The CCFL is charged with drafting, amending, and endorsing provisions on labeling applicable to all foods. Major topics discussed at the meeting included nutrition labeling including trans fatty acids, health claims, biotechnology, country of origin labeling and misleading claims.
119. Codex Committee on Fats and Oils: Led U.S. Delegation to the Codex Committee on Fats and Oils (CCFO), February 3-7, 2003, London, United Kingdom. The Committee reached consensus on the Draft Revised Standard for Olive Oils and Olive Pomace Oils at Step7 and recommended final adoption by the 26^th Session of the Codex Alimentarius Commission (CAC). Although the Committee made significant progress in its discussion of the Draft Standard for Fat Spreads and Blended Spreads, time was not sufficient to complete deliberations and the draft was returned to Step 6. The U.S. delegation had prepared a proposal to amend the Standard for Named Vegetable Oils to add mid-oleic sunflower oil to the Standard. The Committee agreed to "fast track" the proposal and recommend final adoption by the 26^th CAC. The last major topic discussed was the Recommended International Code of Practice for the Storage and Transport of Edible Fats and Oils in Bulk (Draft list of Acceptable Previous Cargoes).

     The U.S., supported by several delegations, recommended discontinuing the elaboration of the "List" and deferring to lists developed by the relevant international organizations: National Institute of Oilseed Products, Federation of Oils, and the Seeds and Fats Association. Other delegations however, did not agree and the Committee finally decided to request the CAC to invite JECFA to develop evaluation criteria and to evaluate the substances of the Draft List that are currently at Step 3.

120. Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology: Led U.S. Delegation to the Codex Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology, Yokohama, Japan, March 11-14, 2003. The Task Force completed work on a draft guideline for the safety assessment of foods derived from bioengineered microorganisms and recommended that the Codex Alimentarius Commission at its next meeting in July 2003 consider the draft guideline for adoption.
121. Codex Task Force for Fruit and Vegetable Juices: Led U.S. Delegation to the Third Session of the Codex Task Force for Fruit and Vegetable Juices, May 6-10, 2003, in Salvador Brazil. The Task Force reached agreement on the principle provisions of the Codex Proposed Draft Standard for Fruit Juices and Nectars and forwarded the Standard to the Codex Alimentarius Commission for final adoption. Still pending within an Annex are specific brix (total soluble solids) values for several fruit juices, including orange juice. Final resolution of the brix value for orange juice will be difficult since major orange juice producers (the United States and Brazil) require higher brix values than other countries (e.g., the members of the European Community) that don't produce orange juice but are major importers of the product. The issue is one of significant trade economics as well as one of potential product fraud.

     The outstanding brix values will be dealt with at the final Session of the Task Force, scheduled for fall, 2004. The Task Force also agreed to discontinue work on the Draft Revised Standard for Vegetable Juices since there is little international trade in this commodity. In this regard the Task Force also recommended that the current (and old) Codex standard for vegetable juices be revoked.

122. Codex Regional Coordinating Committee for North American and the Southwest Pacific: Led U.S. Delegation to the Seventh Session of the Codex Regional Coordinating Committee for North America and the Southwest Pacific (CCNASWP), October 29 - November 1, 2002, in Vancouver, Canada. The Committee received a status report on the WHO/FAO Evaluation of Codex; the Evaluation has since been issued, was initially discussed at a Special Session of the Codex Commission and will be further discussed at length at the 26th Session of the Commission.

     The Committee also reviewed the status of the Codex Trust Fund, to be used to enhance the participation of developing countries in Codex (the Trust Fund was formally launched in February, 2003). CCNASWP extensively reviewed and commented on the Codex Medium Term Plan for 2003-2007; the Plan contains the specific work activities that Codex anticipates undertaking during the period. Additionally, the Task Force considered the work that Codex is undertaking on the subject of traceability/product tracing and developed what essentially constituted a set of principles on the use of traceability/product tracing for use by Codex; this set of principles has subsequently proved valuable in other Codex venues in which the issue of traceability/product tracing is being discussed. CCNASWP also received reports on the regular activities of WHO and FAO.

123. Codex Committee on Methods of Analysis and Sampling: Led U.S. Delegation to the 24th Session of the Codex Committee on Methods of Analysis and Sampling, November 18-22, 2002 in Budapest, Hungary. The Committee agreed to recommend inclusion in the Codex Procedural Manual of working instructions of the selection of methods of analysis. The Committee also proposed that the Commission adopt for Codex purposes the Harmonized IUPAC Guidelines for Single-Laboratory Validation of Methods of Analysis. The Committee also: endorsed several methods of analysis appearing in Codex commodity standards; proposed for adoption several methods of analysis for food additives and contaminants; advanced in the Codex step procedure guidelines for sampling and guidelines for the measurement of uncertainty; and agreed to initiate new work on guidelines for settling disputes on analytical test results.

Internal Processes

124. CAERS (CFSAN Adverse Events Reporting System): On June 15, 2003, CAERS became operational, covering all food, dietary supplement, and cosmetic products. CAERS began receiving approximately 30 adverse event cases per day. In addition, CAERS developed a pilot program with Consumer Product Safety Commission's National Emergency Injury Surveillance System (NEISS) to obtain information on food injuries presenting themselves to physicians in U.S. hospital emergency rooms. Efforts are being made to determine the feasibility of this additional data as a source of cases for CAERS.

     In September, 2003 the CAERS Document Image Management System (DIMS) was also successfully upgraded to stabilize and optimize the management of medical records and other correspondence materials.

     AAPCC (Poison Control Project) pilot contract was awarded in mid-September. The first phase of this project is an IT synchronization, which is underway and on target. Food injuries reported to this system need to be monitored by CFSAN.

125. CFSAN Correspondence Control Enhancements: On October 29, 2002, CFSAN developed and implemented a correspondence control action plan. The objective of the plan is to elevate handling and processing of correspondence within CFSAN. During the past year, the Center's correspondence backlog has consistently remained low.  The dramatic improvement in the reduction of our correspondence backlog won for our Center, the Commissioner's "Write on Time Award "for being the most improved Center in the Agency.
126. CFSAN Review of Warning Letters: In FY 2003, CFSAN staff completed the evaluation of 81 domestic warning letter cases. Review time for completing an individual case range from 4 to 86 work days. Average time for completing a domestic warning letter case was 25 days, down from an average of 39 days in FY 2002.
127. CFSAN Regulations Development Process SOPs: Finalized the standard operating procedures (SOPs) for CFSAN's "Regulations and Related Documents Development Process" to promote quality and efficiency in all stages and improve coordination with the Office of the Chief Counsel, the Office of Regulatory Affairs, and the Office of the Commissioner.
128. CFSAN Regulations Development Training: Provided training to over 300 CFSAN employees on the development of regulations. Eight regulatory development courses were held during FY 2003, in College Park. The courses covered the following topics: Basic Rulemaking Requirements; the Role of Guidance Documents and Compliance Policy Guides; the Process of Developing and Clearing CFSAN Actions, including CFSAN's Revised SOP's; the Role of Economic Analyses in Regulatory Actions; Writing Rules in Plain English; Writing a Legally and Scientifically Defensible Rule; the Paper Reduction Act; and World Treaty Organization Obligations.

Focused Economic-based Regulations

129. Standards of Identity for Yogurt: On July 3, 2003, published an advanced notice of proposed rulemaking (ANPR) (68 FR 39873) to request comments on a petition submitted by the National Yogurt Association to revoke standards of identity for lowfat yogurt and nonfat yogurt and to amend the standards of identity for yogurt and cultured milk.  The comment period for this ANPR closed on October 3, 2003, but, in response to a request, it was reopened on October 29, 2003 (68 FR 61639) until January 27,2004. 

EEO/Diversity Initiatives

130. Recruitment and Retention: In FY 2003, CFSAN establish a Black Male Focus Group (BMFG) led by the Center's Deputy Director. The purpose of this workgroup is to design a plan that specifies action items for the purpose of identifying strategies to improve on the recruitment, hiring, promotion and retention of African-American males.

     The CFSAN Hispanic Program Action Plan recommended by the CFSAN Center Director and developed by the Center's Equal Employment Office continues to be a success. The monitoring of each Action Item identified in the Center's Hispanic Program Action plan is ongoing. Many action items regarding career development, information exchange in the action plan have been accomplishments in FY 2003.

     Since FY 1995, CFSAN has set aside funds to participate in the Hispanic Association of Colleges and Universities (HACU) Student Intern Program, which has led to successful permanent hiring by some upon graduation.

Management Initiatives

131. President's Management Initiative: CFSAN developed a structured process to systematically implement all of the CFSAN-specific tasks as identified under the President's Management Initiative. Successfully addressed were extensive support work for the Agency's consolidation of administrative functions (Shared Services) and the delayering initiative resulting in reductions in layers of supervisory reporting. The A-76 (Competitive Sourcing) studies for the Library and graphics services were completed and new most efficient organizations (MEOs) will be implemented within the calendar year. The functional assessment study of secretarial and support personnel were successfully completed as a prerequisite to competitive sourcing. Other tasks, including additional competitive sourcing, expanded electronic Government and budget and performance Integration will continue into the next fiscal year.
132. Shared Services Organization (SS0) in FDA: CFSAN contributed significant resources to the development and implementation of the new FDA Office of Shared Services (OSS). The new office consolidates previously Center-run service activities such as acquisitions and grants, financial services, real property management, information technology and equal employment opportunity complaints processing into a single Agency organization with a centralized call center. FDA's Office of Shared Services opened for business on October 1, 2003.
133. Human Resources Relocation to Rockville: On April 25, 2003, CFSAN's Human Resources Office (HR) relocated its offices to the current FDA Headquarters site at the Parklawn Building in Rockville, Maryland. The relocation of the CFSAN HR Staff responds to the "Strategic Management of Human Capital" goal under the President's Management Initiative of 2002. This goal requires the consolidation of all FDA personnel offices into a single HR office.
134. CFSAN continue to work with the National Treasury Employee Union (NTEU) and the Cooperation council to fully implement the NTEU collective Bargaining Unit Agreement.

      Accomplishments this fiscal year include:

     • The CFSAN Labor Management Cooperation Council (LMCC) meets on a regular schedule and has established a CFSAN LMCC Charter.
     • NTEU and Management continue to successfully work together on critical issues including:
       • Relocations to MOD I, Chantilly and Vermont Avenue.
       • Space assignments
       • Reserve and handicapped parking needs
       • Realignments/reorganizations
       • Awards
       • Quality Step Increases
       • Student Loan Repayment Program and the Recruitment Referral Award Program.
       • Responses to Agency requests on dollar values of all office space, telephone service, and equipment furnished by FDA to the union.
       • Official NTEU time
     • Award given to CFSAN by DHHS for NTEU Management Council.

135. Relocation Efforts to College Park: In our continued program to relocate CFSAN personnel at our MOD-I /BRF/Chantilly, VA facilities to state of the art facilities in proximity to our College Park Facility, planning continues for the adjunct building and the eventual relocation of personnel from Vermont Avenue and Chantilly Va. to College Park. Pending completion of our adjunct building near our existing College Park Facility, we moved our Color Certification Staff from the FB-8 site in Washington D.C. to an interim (state-of-the-art) facility located in Chantilly VA. Also in FY 2003, we moved the remaining laboratory scientists working in both our Office of Applied Research and Safety Assessment (OARSA) and our Office of Seafood from the FB-8 site to our MOD-I and Beltsville Animal Research (BRF) facilities in Laurel, MD

136. CFSAN Outreach and Information Center: The Center for Food Safety and Applied Nutrition's (CFSAN) Outreach and Information Center (OI&C) has successfully completed its relocation to the Wiley Building at College Park in March 2003. A major component of the OI&C relocation was the installation of all phone lines and software for the new more sophisticated "Call Center." It is our hope that the enhanced voice response and call distribution capability will improve the day-to-day operations as well as our important service to the consumer.
137. Decommissioning of FB-8: CFSAN continues to work diligently in preparing FB-8 for return to the General Services Administration. The reports required by the Nuclear Regulatory Commission (NRC), including the Historical Site Assessment (HAS) of the use of radioactive materials in FOB-8 and the Scoping Survey Sampling Plan (SP) for surveying the facility for radioactivity, were prepared and reviewed and will soon be finalized.
138. "Secure Remote Access" Converted all CFSAN staff utilizing FDA/CFSAN's computerized communications network to the new "Secure Remote Access" (RSA). RSA is a new IT security software/hardware that secures data traveling between individual PC/laptops and FDA/CFSAN's network. It prevents data from being intercepted by hackers or lost or from theft of any new CFSAN supplied PC/laptops.

FY 2003 Program Priorities: "Carryovers into FY 2004"

The following items identify areas where substantial progress has been made, but completion will be carried over in FY 2004.

1. Evaluate results of FY 2002 "high-risk" inspections. Make recommendations on whether the program is accomplishing its objective and identify where and how the program needs to be improved. [1.3.3]
2. Revise consumer advisory on methylmercury in commercial seafood, acting upon the recommendation from the FDA Food Advisory Committee. [1.5.1]
3. Finalize the 1^st edition of the draft Juice Hazards and Controls Guide. [1.6.5]
4. Issue draft guidance for fresh-cut produce. [1.6.7]
5. Issue proposed egg safety rule to further reduce human illnesses from Salmonella Enteritidis. [1.7.1]
6. Develop an enforcement strategy for ensuring that dietary supplement ingredients, when added to conventional foods are lawful. [2.1.3a]
7. Publish a final rule for stanol/sterol esters health claim. [2.2.2c]
8. 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. [3.3.2]
9. 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 plans, such as pharmaceutical or industrial-use crops, do not adulterate the food supply. [3.3.3]
10. Government-wide Paperwork Elimination Act (GPEA): Implement Low Acid Canned Food and Food and Color Additive Petition electronic submission capability via the internet to meet GPEA requirements for industry. [3.4.6]
11. Publish proposed rule on general principles for standards of identity in collaboration with USDA. [3.5.2]
12. Develop proposed rule to amend definition for "milk" in cheese standards to provide for use of fluid ultra-filtered milk. [3.5.3]

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CFSAN 2003 Program Priorities