Part I: Assuring Food Safety and Security

Food Security: Implementing New Legislation

1. Development of the Registration of Food Facilities Final Rule: The Food and Drug Administration issued on October 10, 2003, an interim final regulation (IFR) on Registration of Food Facilities under the Bioterrorism Act of 2002. In developing the final regulation, the FDA held a series of domestic and international outreach meetings with the public, government officials and certain manufacturers, processors and transporters of foods to discuss the final regulation. Also during the development of the interim final rule, FDA allowed two opportunities for public input; the registration IFR was open for comment for 75 days following its publication and FDA reopened the comment period for an additional 30 days in March 2004, to ensure that those commenting on the IFR had the benefit of FDA's outreach and educational efforts and had experience with the information systems, timeframes, and data elements of the registration program. The Food Facility Registration final regulation is positioned for publication in FY 2005.
2. Development of the Prior Notice of Imported Foods Final Rule: The Food and Drug Administration issued on October 10, 2003, an interim final regulation (IFR) on Prior Notice of Imported Foods under the Bioterrorism Act of 2002. In developing the final regulation, the FDA held a series of domestic and international outreach meetings with the public, government officials and certain manufacturers, processors and transporters of foods to discuss the final regulation. Also during the development of the interim final rule, FDA allowed two opportunities for public input; the Prior Notice IFR was open for comments for 75 days following its publication and FDA reopened the comment period for an additional 30 days in March 2004, to ensure that those commenting on the IFR had the benefit of FDA's outreach and educational efforts and had experience with the information systems, timeframes, and data elements of the prior notice system. The Prior Notice of Imported Foods final regulation is positioned for publication in FY 2005.
3. Publication of the Administration Detention Final Rule: On June 4, 2004, published in the Federal Register (69 FR 31659) a final regulation entitled: "Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." This final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which authorizes the use of administrative detention and requires regulations establishing procedures for instituting on an expedited basis certain enforcement actions against perishable food subject to a detention order. This rule was effective July 6, 2004.
   

   Federal Register (69 FR 31659)

4. Food Terrorism Risk Assessment: On October 10, 2003, announced in the Federal Register (68 FR 59078) the availability of a risk assessment for food terrorism and other food safety concerns. Development of this risk assessment is one of a number of steps the Agency is taking to improve its ability to prevent, prepare for, and respond to an incident of food sabotage.

   Risk Assessment for Food Terrorism and Other Food Safety Concerns

5. Outreach for the Bioterrorism Rules: On October, 28, 2003, CFSAN/FDA held a public meeting via satellite downlink to discuss the final regulations implementing two sections in Title III of the Bioterrorism Act regarding Registration of Food Facilities (docket No. 2002N-0276) and Prior Notice of Imported Food Shipments (docket No. 2002N-0278). The purpose for the meeting was to provide information on the rules to the public and to provide a comprehensive picture of the rules and provide the public an opportunity to ask questions of clarification.

   Videos of the October 28, 2003 Satellite Broadcast (also available in French and Spanish)

   On April 1, 2004, CFSAN completed a nine-city domestic outreach effort for small businesses and other stakeholders on the two interim final rules. From April 21-29, 2004, FDA met with over 1,000 government officials, manufacturers, processors, packers, holders, and transporters of foods in a series of outreach meetings on the Food Facility Registration and Prior Notice Regulations. The FDA team conducted international meetings in Beijing, China; Seoul, Korea; Tokyo, Japan; and Bangkok, Thailand. Press briefings and television interviews were conducted during the international tour. The highly successful tour was organized in coordination with the American Embassy in each of the countries visited and in Bangkok, co-sponsored by the National Food Processors Association (Asia Branch). On May 4, 2004, CFSAN staff provided a brief overview of the Bioterrorism (BT) Regulations to the Republic of Armenia delegation at the CFSAN Headquarters in College Park , MD.

6. Food Safety and Security Guidance for the Retail Sector: On December 17, 2003, published in the Federal Register (68 FR 70278) a notice announcing the availability of a guidance document related to food security entitled "Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance." This guidance 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.

   Guidance for Industry - Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance

7. Food Safety and Security Guidance for Cosmetics: On December 17, 2003, published in the Federal Register (68 FR 70278) a notice announcing the availability of a guidance document related to cosmetics security entitled "Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance." This guidance is designed as an aid to operators of cosmetics establishments (e.g., firms that process, store, repack, relabel, distribute, or transport cosmetics or cosmetics ingredients). It identifies the kinds of preventive measures that operators may take to minimize the risk that cosmetics under their control will be subject to tampering or other malicious, criminal, or terrorist actions.

   Guidance for Industry - Cosmetic Processors and Transporters Cosmetics Security Preventive Measures Guidance

8. Registration of Food Facilities Small Entities Compliance Guide: On December 12, 2003, published in the Federal Register (69 FR 69408) a notice announcing the availability of a small entity compliance guide (SECG) for the Registration of Food Facilities IFR. This SECG restates, in simplified format and language, FDA's current requirements for registration of food facilities.
   

   Small Entity Compliance Guide - What You Need to Know About Registration of Food Facilities (also available in French and Spanish)

9. Registration of Food Facilities Compliance Policy Guide: On December 19, 2003, published in the Federal Register (68 FR 70817) a notice announcing the availability of a CPG Sec. 110.300 entitled "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." This CPG provides written guidance to FDA staff on enforcement of section 305 of the Bioterrorism Act and the Agency's implementing regulation, which require, beginning on December 12, 2003, registration with FDA for all domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States.
   

   Compliance Policy Guide, Guidance for FDA Staff: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

10. Registration of Food Facilities IFR - Q&A Guidance Document: On December 4, 2003, issued guidance to industry entitled "Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities." This guidance responds to various questions raised about section 305 of the Bioterrorism Act and the Agency's implementing regulation, which require facilities that manufacture/process, pack, or hold food for consumption in the U.S. to register with FDA by December 12, 2003.

    Guidance for Industry - Questions and Answers Regarding Registration of Food Facilities

11. Registration of Food Facilities IFR -- Q&A Guidance Document: On January 12, 2004, announced in the Federal Register (69 FR 1675) the availability of the revised guidance entitled: Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities (Edition 2). As noted in the first notice in response to requests for clarification of the registration interim final rule by providing guidance in a question and answer format.

    Guidance for Industry - Questions and Answers Regarding Registration of Food Facilities (Edition 2)

12. Registration of Food Facilities IFR - Q&A Guidance Document: On February 17, 2004, announced in the Federal Register (69 FR 7347) the availability of a revised guidance entitled: "Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities (Edition 3)." This guidance continues to respond to various questions raised about section 305 of the Bioterrorism Act.

    Guidance for Industry - Questions and Answers Regarding Registration of Food Facilities (Edition 3)

13. Registration of Food Facilities IFR - Q&A Guidance Document: On August 6, 2004, announced in the Federal Register (69 FR 47765) the availability of a revised guidance entitled: "Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities (Edition 4)." As noted in previous notices announcing the availability of guidance for food facility registration, FDA continues to respond to requests for clarification of the registration interim final rule by providing guidance in a question-and-answer format.

    Guidance for Industry - Questions and Answers Regarding Registration of Food Facilities (Edition 4)

14. Prior Notice of Imported Foods Small Entities Compliance Guide: On December 12, 2003, published in the Federal Register (69 FR 69408) a notice announcing the availability of a SECG for the IFR on Prior Notice of Imported Foods. This SECG restates, in simplified format and language, FDA's current requirements for Prior Notice of Imported Foods.
    

    Small Entity Compliance Guide - What You Need to Know About Prior Notice of Imported Food Shipments (also available in French and Spanish)

15. Prior Notice of Imported Foods Compliance Policy Guide: On December 15, 2003, published in the Federal Register (68 FR 69708) a notice announcing the availability of a Compliance Policy Guide (CPG) Sec 110.310 entitled: "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." This CPG provides written guidance to FDA staff and the U.S. Customs and Border Protection (CBP) staff on enforcement of section 307 of the Bioterrorism Act and the Agency's implementing regulations, which require, beginning on December 12, 2003, prior notice for all food imported or offered for import into the United States.

    Compliance Policy Guide, Guidance for FDA and CBP Staff: Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (also available in French and Spanish)

16. Prior Notice of Imported Foods IFR -- Q&A Guidance Document: On December 16, 2003, announced in the Federal Register (68 FR 69957) a notice of availability of the Guidance for Industry: Questions and Answers on the Interim Final Rule on Prior Notice of Imported Food.

    Guidance for Industry - Prior Notice of Imported Food Questions and Answers

17. Joint FDA/CBP Plan for Prior Notice Timeframes: On April 14, 2004, the FDA and the U.S. Bureau of Customs and Border Protection (CBP) announced in the Federal Register (69 FR 19765) the availability of the plan entitled "Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes." The plan, which includes an assessment schedule, describes the process by which FDA and CBP intend to increase integration and examine whether to amend the timeframe requirements in FDA's prior notice IFR to have the same advanced notice timeframes for arrivals by land via road or rail, or arrival via air that are currently in CBP's advance electronic information rule.

    Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes
    Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes (REVISED August 2004)

18. Prior Notice of Imported Foods IFR -- Q&A Guidance Document: On May 3, 2004, announced in the Federal Register (69 FR 24070) the availability of a revised guidance entitled: "Questions and Answers Regarding the Interim Final Rule on Prior Notice of Imported Foods (Edition 2)." This guidance responds to various questions raised about section 307 of the Bioterrorism Act and the Agency's implementing regulation which require the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the U.S.

    Guidance for Industry - Prior Notice of Imported Food Questions and Answers (Edition 2)

19. Revised Prior Notice of Imported Foods Compliance Policy Guide: On June 29, 2004, announced in the Federal Register (69 FR 38906) the availability of a revised Compliance Policy Guide (CPC) regarding Prior Notice of Imported Foods under the Bioterrorism Act. The original CPG which was published in the Federal Register of December 15, 2003 (68 FR 69708), provides written guidance to FDA's and the Customs and Border Protection's (CBPs) staff on enforcement of section 307 of the Bioterrorism Act. This CPG has been revised to provide additional guidance to FDA and CBP staff regarding how to address food that is imported or offered for import for noncommercial purposes with a noncommercial shipper. The revised CPG also reflects a change in the date of Stage III enforcement guidance for the interim final rule for Prior Notice of Imported Foods from May 13, 2004, to June 4, 2004.

    Compliance Policy Guide, Guidance for FDA and CBP Staff: Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (REVISED June 2004)

20. Revised Prior Notice of Imported Foods Compliance Policy Guide: On August 16, 2004, announced in the Federal Register (69 FR 50389) the availability of a revised joint FDA/Customs and Border Protection (CBP) Compliance Policy Guide regarding Prior Notice of Imported Foods. This document describes certain changes to the Joint FDA/CBP plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes that was announced in the Federal Register of April 14, 2004. Since the prior notice interim final rule (IFR) became effective in December 2003, FDA and CBP have been reviewing the data quality of prior notice submissions. This review has revealed practical implementation problems with certain data elements, such as registration number, bill of lading number, and ultimate consignee. In part, these problems result from a lack of standardization. The problems also arose due to the practical difficulties faced by submitters in obtaining required information in complex commercial settings. Therefore, the CPG was revised to address these practical implementation problems.

    Compliance Policy Guide, Guidance for FDA and CBP Staff: Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (REVISED August 2004)

21. Prior Notice Contingency Plan for Systems Outages: On August 16, 2004, announce the availability in the Federal Register (69 FR 50388) Guidance for Industry: Prior Notice of Imported Food Contingency Plan for System Outages. The contingency plan provides guidance on submitting prior notice of imported food during system outages affecting the applicable FDA and Customs and Border Protection (CBP) program systems.

    Guidance for Industry - Prior Notice of Imported Food Contingency Plan for System Outages

22. IT System to Support FDA's Prior Notice Requirements: The FDA's Office Regulatory Affairs (ORA) completed the initial implementation of the IT systems to support the prior notification requirements for all imported food shipments as a requirement of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). On December 12, 2003, ORA modified its OASIS system and implemented the Prior Notice System Interface (PNSI) to support the prior notice provisions of the Bioterrorism Act. Between December 12, 2003, and October 30, 2004, four additional software releases were implemented to support the enforcement phases of the provision.
23. IT System to Support the Registration of Food Facilities: As part of the new "FDA Industry Systems (FIS)," FDA implemented the "Food Facility Registration Module (FFRM)" for the electronic registration of food facilities. This responds to a requirement of the Bioterrorism Act that all domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA.

Food Security: Emergency Preparedness

24. Food Emergency Response Network (FERN): CFSAN initiated, in conjunction with FDA's Office of Regulatory Affairs, a multi year effort to support the development of the Food Emergency Response Network (FERN), with progress this year critical to the establishment of the laboratory network. As such, CFSAN has been involved in multiple activities including:
    • Serving as the lead for the proficiency program subcommittee, serving as the operational laboratory for microbiological proficiency samples, and supporting the activities of the ORA Forensics laboratory for chemical proficiency samples.
    • Posted interim methods for priority chemical and microbiological agents on both the FERN and the CDC Laboratory Response Network (LRN) websites.
    • Provided training to ORA, USDA, FERN, and LRN labs on detection of priority microbiological agents in a BSL-3 environment and on general food sampling protocols
    • Initiated with AOAC a review of the criteria for the validation of microbiological methods.
    • Supported the development of the organizational structure of FERN including active participation in the Steering Committee and all subcommittees.
    • Established a "FERN store" for the stockpiling and distribution of kits and specialized reagent to the FERN labs.
    • Continued to identify and address infrastructure, training, and procedural needs for increased preparedness of CFSAN labs including acquisition of key equipment for microbiological and chemical agent detection.
    • Completed all requirements for the use of select agents within three of the CFSAN labs, including inspection of laboratories by CDC.
    • Two additional CFSAN laboratories (NCFST and College Park) into the LRN.
25. Food Threat Assessment Evaluations: FDA produced a "For Official Use Only" (FOUO) version of its classified Operational Risk Management (ORM) vulnerability assessment. CFSAN briefed FDA management, field management, state commissioners of health and agriculture and numerous food trade associations on the content of the document.

    FDA utilized a new vulnerability assessment tool to further refine our initial vulnerability assessments. These assessments were completed utilizing the CARVER targeting tool. CARVER is an offensive targeting tool contrasted with the Operational Risk Management vulnerability assessment (ORM) which is a defensive vulnerability assessment tool.

26. Intramural and extramural research to determine threat agent characteristics in foods and dose response for humans: CFSAN's Office of Plants and Dairy Foods (OPDF) has initiated a collaborative project with the National Center for Food Safety and Technology (NCFST) entitled "Survival and Growth of Non-traditional Pathogens in Food." This project will characterize the ability of non-traditional vegetative pathogens (or pathogen surrogates) to survive and grow in a variety of foods using classical and high-throughput techniques. Both liquid (dairy, fruit juice) and solid (produce) food systems will be tested.
27. Establishment of Prevention Measures: In an effort to establish prevention measure shields for foods identified as a high security concern, CFSAN continued to acquire and communicate scientific information to the appropriate sectors in the following areas:
    • CFSAN conducted numerous briefings with food industry representatives and State Agriculture and Health Commissioners on its initial food security assessment efforts.
    • Awarded a contract to the Institute of Food Technologists to develop and conduct threat assessment training for medium and small food producers nationwide that will lead to improved security of food production facilities and processes.
    • Partnered with select industries to provide technical assistance in conducting CARVER threat assessments for food commodities identified as higher concern.
28. Intramural and extramural research on prevention strategies: Three activities were initiated:
    1. (1) CFSAN has initiated a collaborative project with NCFST entitled "Thermal resistance of non-traditional microbial agents."
    2. (2) CFSAN is in the planning stages of two collaborative projects with NCFST. The first project is entitled "Decontamination of Food Processing Facilities and Equipment." The second project is entitled "Effect of Food Processing on the Inactivation of Protein Toxins and Bacillus anthracis Spores." CFSAN and NCFST are presently interviewing post-doctoral candidates, who will be hired to perform these projects in the BSL-3 laboratory and pilot plant that is being built at NCFST.
29. Validate and develop methods for use in foods and prioritize according to FDA food threat assessment: In September 2003, CFSAN awarded cooperative agreement research funds to augment its food safety and food security research methods development program. The applied focus of all research categories is to enhance the ability of the Agency to detect non-traditional microbial, chemical, and toxin adulterants in food, dietary supplements, food additives, and cosmetics. Five new grants totaling $2,828,759 were funded. The grants cover the full cost of the awards, which are typically for 3 years.
    
    The following grants have been awarded:
    • Project 1: Development of Waveguide Immunoassay for Yesinia pestis, University of Georgia Research Foundation Inc.
    • Project 2:Rapid Immunoassay Silver Amplification Test System, Cornell University -- Department of Food Sciences
    • Project 3: Rapid Food Screening for Biological Toxins on a Microchip, Naval Research Laboratory
    • Project 4: Development of a PCR Device for Pathogen Detection, Cornell University - Material Research Laboratory
    • Project 5: Rapid Screening of Foods for Toxins by TLC-Bioluminescence, ChromaDex Inc.

    On May 5-6, 2004, CFSAN hosted its 5^th FDA/CFSAN Food Safety and Food Security Extramural Research Review Conference for all principle investigators of these grants (and other counter-terrorism research related grants).

30. Proficiency Test Samples: During FY 2004, CFSAN provided FDA's food testing laboratories both chemistry and microbiological proficiency test samples to evaluate analyst proficiency in testing for organisms of food security and safety concerns.
31. Emergency Response Exercises: CFSAN participated in numerous emergency response exercises that included all levels of government:
    • March 2004, FDA participated in an FDA Radiological Emergency Response Plan Exercise.
    • May 2004 FDA participated in an FDA Chemical/Biological Plan Emergency Response Exercise.
32. Emergency Response Training: The CFSAN Emergency Response Plan (CERP) was revised, posted on CFSAN's intranet and distributed. In cooperation with CFSAN's Staff College, a workshop was conducted to prepare the "CFSAN Situation Room" Staff for a 3-day course at the Emergency Management Institute in Emmitsburg, MD and refresher Emergency Management Training for CFSAN leadership.
33. Training on the Bioterrorism Final Rules: Training on two of the four BT Regulations, Food Facility Registration and Prior Notice of Imports, has been completed. A worldwide "Satellite downlink" public broadcast on the two final regulations was held on October 28, 2003. On the 3^rd and 7^th of November 2003, FDA held (1) Bioterrorism Legislations' Rules and Procedures -- Handling questions (Satellite Downlink); and (2) Implementing the Bioterrorism Legislation's Rules and Procedures.
34. Participation in IFWG: Under the initial direction of the White House Homeland Security Council’s Interagency Food Working Group (IFWG), CFSAN served as lead for the Department of Health and Human Services (HHS) in combination with the U.S. Department of Agriculture (USDA), the Department of Homeland Security (DHS), the National Association of State Departments of Agriculture (NASDA), the Association of State and Territorial Health Officials (ASTHO) and the National Association of County and City Health Officials (NACCHO) in forming the Food and Agriculture Sector critical infrastructure protection organization that brings together state officials and industry to further strengthen homeland security in the area of food defense.
35. Bioterrorism Help Desk: October 16, 2003, FDA implemented the "FDA Industry Systems Help Desk" to respond to general and technical questions about the Bioterrorism Act with respect to food facility registration and prior notice of imported foods. The Help Desk has responded over 100,000 inquiries from stakeholders on the Bioterrorism rules.
36. 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 prepared a summary of its activities and accomplishments for FY 2004. The full report has been completed and is currently undergoing Administration clearance.
37. Laboratory Upgrade: CFSAN initiated the upgrade of laboratory facilities at the National Center for Food Safety and Technology (NCFST) to the BSL-3 level. The purpose of this upgrade is to allow NCFST to conduct food processing and packaging research that is geared to enhancing food security.
38. Continue MOD I Upgrade: In FY 2004, the BSL3 build-out at the CFSAN's MOD-1 facility was brought to an estimated 95% completion level. Formal inspection, certification and other final commissioning tasks are planned for completion in early FY 2005.

Domestic Inspections.

39. Domestic "High-Risk" Inspections: Conducted 7, 244 (106%) 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% (6,840) of the "high risk" domestic food establishments.
40. "High-Risk" Inspection Evaluation: As of September 30, 2004, all "High Risk" data for FY-01, 02 & 03 was compiled and delivered to the responsible program offices within CFSAN. The information and summary conclusions were used in making recommendations and redirection of the program where appropriate.

Imports and Foreign Inspections

41. Field Examinations of Imported Food: In conjunction with FDA's Office of Regulatory Affairs, completed 70,926 (118%) field examinations of imported food shipments entering U.S. ports of entry for release into the U.S. commerce. Our goal was to complete 60,000 field examinations for the current fiscal year. FDA exceeded its goal by 164 percent. This is more than a 6-fold increase from the 12,000 field import examinations conducted just three years ago in FY 2001.
42. Foreign Inspections: Through FDA's Office of Regulatory Affairs (ORA), conducted 150 inspections of foreign food establishments with top priority to "high"risk" foods. Due to travel restrictions based on world events and budget constraints, FDA was able to conduct only limited foreign inspections. Many foreign inspections planned for FY 2004 will be rescheduled in FY 2005.
43. Foreign Inspections Evaluations: CFSAN continues to receive FY2004 foreign Establishment Inspection Reports (EIR) for evaluation, as the ORA Field Districts complete reports covering inspections conducted during the last quarter of FY 2004. As of 10/20/04, CFSAN has received 145 of the current 150 foreign inspections (EIRs) reported by the field districts. Of the 145 EIRs received, the Center is currently reviewing 33 and the remaining 112 EIRs have been reviewed and given a final inspection classification (OAI-25, VAI-49, NAI-38).
44. Private Laboratory Requirements: On April 29, 2003, published in the Federal Register (69 FR 23460) a proposed rule on requirements pertaining to sampling services and private laboratories used in connection with imported food. The proposal would require samples to be properly identified, collected, and maintained. Additionally, the proposal would require laboratories to use validated or recognized analytical methods, and to submit analytical results directly to FDA. The proposal is intended to help assure the integrity and scientific validity of data and results submitted to FDA.

    Proposed Rule: Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection With Imported Food (69 FR 23460)

Seafood Safety

45. Report to Congress -- Seafood HACCP: House Report 108-193 of the Agriculture Rural Development, Food and Drug Administration and Related Agencies 2004 Appropriations Language directed FDA to provide a description of the HACCP temperature requirements for imported seafood products and identify any planned or ongoing FDA research projects on the effectiveness of new technologies to control hazards due to improper temperature. CFSAN prepared a response to Congress and it is currently under review by the Administration.
46. Report to Congress -- Chloramphenicol in Shrimp: House Report 108-193 of the Agriculture Rural Development, Food and Drug Administration and Related Agencies 2004 Appropriations Language directed FDA to report on the sampling frequency and violation rates for imported shrimp, and efforts to ensure that any shrimp that test positive for chloramphenicol will not be subsequently consumed. CFSAN prepared a response to Congress and it is currently under review by the Administration..
47. Methylmercury Advice: On March 19, 2004, FDA and the Environmental Protection Agency (EPA) announced the joint consumer advisory entitled: "What You Need to Know about Mercury in Fish and Shellfish." The joint advisory made several recommendations for reducing exposure to high levels of mercury in women who may become pregnant, pregnant women, nursing mothers, and young children. This unifies advice from both FDA and EPA and supersedes FDA's and EPA's 2001 advisories.

    What You Need to Know About Mercury in Fish and Shellfish (also available in Spanish)

48. Vibrio vulnificus: FDA has continued to work with the Interstate Shellfish Sanitation Conference (ISSC) to encourage the post-harvest treatment of Gulf Coast oysters and to monitor progress toward the ISSC illness reduction goals. FDA participates in the Vibrio Management Committee of the ISSC and a number of working groups organized under that committee. The ISSC conducted a survey that demonstrates that the shellfish industry's capacity to conduct post-harvest treatment in Gulf Coast oysters well exceed its goal of 25%. The ISSC continued to refine the standardized methods for validating post harvest treatment processes to facilitate industry adoption of the processes.

Fruits and Vegetables

49. Mexican government Certification Program for Cantaloupes Intended for Export to the U.S.: FDA/CFSAN provided technical assistance to Mexican counterparts on several iterations of the Mexican Federal Recognition Program (FRP) that contain requirements to be followed during the production, harvest, packing, and processing of cantaloupe to reduce the risk of foodborne illness outbreaks associated with the consumption of cantaloupe from Mexico. The final Mexican FRP for cantaloupe was circulated for review by all agencies in January, 2004. Mexico has also developed a FRP for the production green onions, based largely on the FRP for cantaloupe.
50. Juice HACCP Guidance: On March 3, 2004, published in the Federal Register (69 FR 10051) a notice announcing the availability of a guidance document related to the processing of juice entitled: "Guidance for Industry: Juice HACCP Hazards and Controls Guidance, First Edition." The guidance represents FDA's views on potential hazards in juice products and recommends how to control such hazards and it is designed to assist juice processors in the development of their HACCP plans.

    Guidance for Industry - Juice HACCP Hazard and Controls Guidance, First Edition

51. FDA Food CGMP Regulations: CFSAN conducted three research projects related to Food GMP modernization, a literature search, an expert elicitation and survey of food recalls from 1999-2003. Based in part on this research, we concluded that a modernization of the Food GMPs (21CFR 110) was needed. On May 21, 2004, announced in the Federal Register (69 FR 29220) three public meetings intended to obtain comments about FDA's Good Manufacturing Practices (GMPs) in manufacturing, packing, or holding human food regulations (21 CFR part 110).

    Notice of Public Meetings (69 FR 29220)

52. 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 in three countries -- Guatemala, Honduras and Korea. Participants were trained in good agricultural and manufacturing practices. The course consisted of lectures, case studies, practical exercises, and in come cases farm visits. Participants took part in an extensive, commodity specific, farm exercise based on conditions specific to the region.
53. Produce Safety: On October 18, 2004, FDA posted the 2004 Produce Safety Action Plan. Because of the importance of fresh produce in a healthy diet and continuing outbreaks associated with the consumption of fresh produce, FDA developed the 2004 Produce Safety Action Plan to further minimize foodborne illness associated with the consumption of fresh produce. The 2004 Produce Safety Action Plan addresses all major points from the farm to the table where contamination of produce could occur. It covers fresh fruits and vegetables in their unpeeled natural form and raw minimally processed products, i.e., fresh-cut produce.

Egg Safety

54. Egg Safety Proposed Rule: On September 22, 2004, published in the Federal Register (69 FR 56823) the proposed rule: "Prevention of Salmonella Enteritidis in Shell Eggs During Production." This proposal would require shell egg producers to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm.

    Proposed Rule: Prevention of Salmonella Enteritidis in Shell Eggs During Production (69 FR 56823)

Listeria

55. On May 24, 2004, issued in the Federal Register (69 FR 29564) a notice announcing that a petition has been filed that requests that the Agency establish a regulatory limit of 100 colony forming units per gram for Listeria monocytogenes in foods that do not support the growth of the microorganism. The Agency requested comments on the petition. The comment period closed August 9, 2004.

    Notice: Listeria Monocytogenes; Petition to Establish a Regulatory Limit (69 FR 29564)

Chemical Contaminants, Pesticides and Other Hazards

56. Acrylamide: In March 2004, FDA released acrylamide testing results for the FY03 Total Diet Study (approximately 700 samples) and other selected samples analyzed at CFSAN (approximately 50 samples). FDA is now preparing to release data from the FY04 Total Diet Study (approximately 400 samples) and other selected samples tested by a contract laboratory (approximately 470 samples). These data will be useful to FDA for determining consumer exposure to acrylamide from the diet to assess the risk of acrylamide in foods.
    

    Exploratory Data on Acrylamide in Food, FY 2003 Total Diet Study Results
    Exploratory Data on Acrylamide in Food

57. Radionuclides: On January 14, 2004, published in the Federal Register (69 FR 2146) a notice announcing the availability of a draft CPG entitled: "Guidance Levels for Radionuclides in Domestic and Imported Foods." The draft CPG rescinds and replaces the current CPG Sec. 560.750 Radionuclides in Imported Foods -- Levels of Concern (CPG 7119.14). The draft CPG provides updated guidance levels for radionuclide activity concentration in food offered for import and makes these same guidance levels for radionuclide activity concentration applicable to food in domestic interstate commerce for the first time.

    Compliance Policy Guide, Guidance for FDA Staff - Guidance Levels for Radionuclides in Domestic and Imported Foods

58. Pesticides Monitoring: Over 8,000 food samples were collected and analyzed for pesticide residues during the Fiscal Year 2004. FDA must maintain resource levels devoted to the sampling and analyses of pesticide, not only to ensure that the U.S. food supply is safe, but also to reduce dietary exposure.
59. FDA's Dioxin Strategy: FDA continued implementation of its dioxin strategy including monitoring, method development, and identification of opportunities to reduce exposure. Specific accomplishments in FY2004 include the following:
    • In March 2004, CFSAN posted data on dioxin-like compounds (DLCs) in 2000, 2001 and 2002 Total Diet Study food samples.

      Dioxin Analysis Results/Exposure Estimates

    • In July 2004, CFSAN posted exposure estimates for DLCs in total U.S. population and 14 age-sex subgroup populations.

      PCDD/PCDF Exposure Limits

60. Perchlorate Analytical Method: FDA developed an accurate and sensitive method to determine the perchlorate anion in selected fruits and vegetables and also in bottled water and milk using ion chromatography-tandem mass spectrometry. The method was posted on the CFSAN website in March 2004 and it is successfully being used by not only FDA, but other government and private laboratories.
61. Chloramphenicol: In FY 2001 and early FY 2002, the European Union and Canada reported finding chloramphenicol (CAP), a banned substance, in honey exported from China. In response to their findings, FDA developed new analytical methodology and began testing honey for CAP. From March 1, 2002 through December 31 2003, FDA tested 698 imported honey samples and found 37 positive samples. During 2004, FDA also tested 13 domestic honey samples, all of which were negative. From January 1, 2004, through September 2004, FDA tested 108 imported honey samples and found 1 positive sample.
62. Lead in Candy: On March 25, 2004, issued letters to manufacturers, importers and distributors of imported candy. The letter is to inform applicable parties of actions the FDA intends to take to reduce further the potential exposure of children to lead from candy products.

    Letter to Manufacturers, Importers, and Distributors of Imported Candy

63. Lead in Imported Candy: Reviewed all FDA data on lead in imported candy from FY 2000 thru FY 2004 and collaborated with FDA's field offices to prioritize categories of Mexican candy for sampling.

Transmissible Spongiform Encephalopathies (TSEs)

64. BSE Interim Final Rule: On July 14, 2004, published in the Federal Register (69 FR 42255) an interim final rule: "Use of Materials Derived From Cattle in Human Food and Cosmetics prohibiting the use of certain cattle material, in human food, including dietary supplements, and cosmetics. Prohibited cattle materials include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS)(Beef).

    Interim Final Rule: Use of Materials Derived From Cattle in Human Food and Cosmetics (69 FR 42255)

65. Initiation of BSE Risk Assessment: Initiated work on a BSE risk assessment. Harvard University is in the process of modifying the BSE risk assessment model to use the available data to accommodate FDA-regulated products.
66. BSE Risk Assessment: On July 14, 2004, announced in the Federal Register (69 FR 42191) the availability of the risk assessment regarding the potential for variant Creutzfeldt-Jakob Disease (vCJD) in humans from exposure to cosmetics containing cattle-derived protein infected with the bovine spongiform encephalopathy (BSE) agent. FDA is making this document available to communicate publicly the potential risk to public health from cosmetics made with cattle materials that may be contaminated with the BSE agent.

    An Evaluation of the Risk of Variant Creutzfeldt-Jakob Disease from Exposure to Cattle-Derived Protein Used in Cosmetics

67. BSE in CFSAN-regulated Products: On July 14, 2004, published in the Federal Register (69 FR 42287) an advance notice of proposed rulemaking (ANPRM): "Federal Measures to Mitigate BSE Risks: considerations for Further Action."

    Proposed Rule: Federal Measures to Mitigate BSE Risks: Considerations for Further Action (69 FR 42287)

68. BSE Recordkeeping Requirements: On July 14, 2004, published in the Federal Register (69 FR 42275) a proposed rule: Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle. This is a companion rulemaking to FDA's interim final rule entitled "Use of Materials Derived From Cattle in Human Food and Cosmetics," published in this issue of the Federal Register.

Food Allergens

69. Food Allergen Industry Outreach: CFSAN participated in more than 21 industry, consumer and regulatory conferences to discuss FDA's activities aimed at increasing awareness of the presence of allergens in foods.

Dairy Safety

70. Federal Import Milk Act (FIMA) CPG: On October 29, 2004, announced in the Federal Register (69 FR 63158) the availability of the draft revised Compliance Policy Guide: Imported Milk and Cream -- Federal Import Milk Act. This revision of the FIMA CPG updates the policy regarding which dairy products require permits to enter the U.S. This updated CPG revision will benefit FDA employees who examine dairy products presented for entry into the U.S. and foreign dairy processors and exporters by clarifying which dairy products are subject to the FIMA permit requirements.

    Notice: Draft Revised Compliance Policy Guide "Sec. 560.400--Imported Milk and Cream--Federal Import Milk Act (CPG 7119.05) (69 FR 63158)

Education

71. Listeria and Methylmercury Education: In our effort to train health educators to teach food safety to pregnant women and women who may become pregnant about the risks of methylmercury in seafood and Listeria monocytogenes in refrigerated food, print materials and videos are completed and in distribution to targeted audiences(s) in English only.
72. Seafood Safety: In our effort to develop and distribute seafood safety education materials, methylmercury advisory information and fotonovelas for Vibrio vulnificus in seafood are completed and in distribution to targeted audiences nationwide.
73. Hispanic Outreach: In FY 2004 CFSAN exhibited and distributed Spanish and English food safety materials at seven Radio Unica health fairs held in San Francisco, CA; Miami, FL; Phoenix, AZ; and Houston, Dallas, San Antonio, and McAllen, TX.
74. Preventive Controls: On May 28, 2004, the Institute of Food Technologists completed a contract awarded to review the preventive controls that industry may take to reduce the risk for an intentional act of terrorism or contamination using the US food supply for high risk and medium risk food commodity/agent combinations.
75. Methylmercury Advisory: On December 10-11, 2003, FDA's Food Advisory Committee (FAC) met to provide a status report and response to the FAC recommendations on methylmercury in fish and shellfish.

    Transcripts:
    Food Advisory Committee Meeting Methylmercury (Volume I)
    Food Advisory Committee Meeting Methylmercury (Volume II)

76. Food Safety and Security Health Professionals Program: On April 7, 2004, FDA, in partnership with the U.S. Centers for Disease Control and prevention (CDC), the U.S. Department of Agriculture/Food Safety and Inspection Service (FSIS), the American Medical Association (AMA) and the American Nurses Association (ANA) issued an educational primer entitled: "Diagnosis and Management of Foodborne Illnesses: A Primer for Physicians and Other Health Care Professionals."
    

Part II: Improving Nutrition and Dietary Supplement Safety

Nutrition, Health Claims and Labeling

77. Obesity Working Group (OWG): On August 11, 2003, then-Commissioner Mark B. McClellan, M.D., Ph.D., established FDA's Obesity Working Group (OWG). The OWG met eight times; received briefings from invited experts; held one public meeting, one workshop, two roundtable discussions; solicited comments on obesity-related issues for submission to the Docket (Docket No. 2003N-0338); and prepared and delivered a report with recommendations to address the obesity problem from FDA's perspective and authorities.
78. OWG Report: On March 12, 2004, the OWG publicly released its "Calories Count" report. The report contains a series of short and long-term recommendations for dealing with the obesity problem centered on the scientific fact that, at its most basic level, weight control requires caloric balance.

    Calories Count - FDA Obesity Working Group Report and Related Information

79. Enforcement Against Misleading Claims: FDA continued to work with the Federal Trade Commission (FTC) to address false or misleading claims in dietary supplement products, with a strong focus on weight loss claims. In FY2004, FDA and FTC took enforcement action against Cortislim, a product that was heavily advertised through infomercials, as well as radio and print advertisements and Internet websites. FDA also issued 16 Warning Letters to firms promoting weight loss products on the Internet with false or misleading claims. These letters were followed-up by a field assignment to inspect those firms that did not make corrections.
80. Serving Size Declaration: As part of FDA's Obesity Initiative, serving size declaration on food products was highlighted as a priority for the agency. CFSAN's Office of Nutritional Products, Labeling and Dietary Supplements issued a "Dear Manufacturer" letter on March 12, 2004, to remind the food industry about the rules for determining appropriate serving size. The "Dear Manufacturer" letter also advised the industry that FDA intends to highlight accurate serving size as an enforcement priority.

    Letter to Food Manufacturers about Accurate Serving Size Declaration on Food Products

81. Nutrition Information in Restaurants: In working with a third-party facilitator to develop options for providing voluntary standardized nutrition information at point of purchase in a restaurant setting, CFSAN staff is serving on the Project Advisory Group for the contract with the Keystone Center, signed in June 2004, to conduct a national policy dialogue to address obesity issues involving foods consumed away from home (including restaurants). Keystone has conducted interviews with a broad cross-section of representative stakeholders on both of these issues (including representatives from CFSAN). As a next step Keystone will provide a report on the interviews and future plans for convening the national policy dialogue forum.
82. Adolescent Obesity: In working with a third-party facilitator to develop approaches including partnerships for educating consumers, particularly adolescents, about obesity, CFSAN staff is serving on the Project Advisory Group for the contract with the Keystone Center, signed in June 2004, to conduct a national policy dialogue to address obesity issues involving ways to combat pediatric obesity. As of mid-September, Keystone has conducted 45 initial interviews with a broad cross-section of representative stakeholders on both of these issues (including representatives from CFSAN), and has plans to conduct an additional 20-35 interviews. As a next step Keystone will provide a report on the interviews and future plans for convening the national policy dialogue forum.
83. Qualified Health Claims: On November 25, 2003, published in the Federal Register (68 FR 66040) an advance notice of proposed rulemaking (ANPRM) to request comments on alternatives for regulating qualified health claims in the labeling of conventional human foods and dietary supplements. FDA also solicited comments on various other issues related to health claims and on the appropriateness and nature of dietary guidance statements on conventional food and dietary supplement labels.

    ANPRM: Food Labeling; Health Claims; Dietary Guidance (69 FR 66040)

84. Consumer Research on Qualified Health Claims: On May 2004, completed consumer research to help ensure that qualified health claim messages in the labeling of foods and dietary supplements employ the most effective wording so that the messages are not misleading to consumers.
85. Health Claims, Dietary Guidance: On January 27, 2004, published in the Federal Register (69 FR 3868) an extension of the comment period for the ANPRM entitled: "Food Labeling: Health Claims; Dietary Guidance." FDA extended the comment period for the ANPRM for 30 days, until February 25, 2004.

    ANPRM: Food Labeling; Health Claims; Dietary Guidance; Extension of Comment Period (69 FR 3868)

86. Health claims: Nutrient Content Claims: On May 4, 2004, published in the Federal Register (69 FR 24541) a notice reopening for 60 days the comment period for the proposed rule entitled: "Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and other Specific Requirements for Individual Health Claims. In that document, FDA proposed to amend its existing nutrient content claims and health claims regulations to provide additional flexibility in the use of these claims on food products.

    Proposed Rule, Reopening of the Comment Period: Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims (69 FR 24542)

87. Nutrient Content/Health Claims Petitions: During FY 2004 CFSAN completed the review of eight nutrient content claim petitions/notifications and twenty-three health claim petitions/notifications. All were completed within the statutory timeframe.
88. Infant Formula Premarket Notifications: Completed twenty-five 90-day infant formula notifications in FY 2004. All were completed within the mandated 90-day review period.
89. Trans Fat Education: FDA Public Affairs Specialists were provided a technical presentation promoting trans fat education and outreach, including a script about the new labeling requirements to facilitate accurate communication to stakeholders. The FDA Consumer featured a cover story about trans fats and all information, including press documents, regulations, Q&A's, and consumer information was posted on the CFSAN Web site. These documents also were sent to numerous CFSAN stakeholders. CFSAN also completed a Web-based interactive article in English and Spanish and a new presentation to accompany the consumer article.

    Trans Fat Now Listed With Saturated Fat and Cholesterol on the Nutrition Facts Label

90. Trans Fat Proposed Rulemaking: On March 1 and April 19, 2004, published in the Federal Register (69 FR 9559 and 69 FR 20838, respectively) two notices extending the comment period for an ANPRM on Trans Fatty Acids in Nutrition Labeling published in the Federal Register of July 11, 2003 (60 FR 41507).

    ANPRM, Reopening of Comment Period: Trans Fatty Acids in Nutrition Labeling (69 FR 9559)
    ANPRM, Extension of Comment Period: Trans Fatty Acids in Nutrition Labeling (69 FR 20838)

91. Enforcement Activities for Inappropriate Labeling of Conventional Foods: CFSAN approved 83 Warning Letters, 31 Import Detentions and 1 Seizure recommendation from the FDA field district offices. In addition, CFSAN issued three Warning Letters related to inappropriate labeling of conventional foods.

Dietary Supplements

92. 75-Day New Dietary Ingredient Notification: During FY 2004, CFSAN filed 49 and responded to 47 notifications for dietary supplements containing new dietary ingredients. 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. A total of 31 letters identified deficiencies or safety concerns, one (1) did not fulfill the regulations found at 21 CFR 190.6, eight (8) were acknowledgements and seven (7) were not dietary ingredients.
93. 30-Day Nutrient Content/Health Claim Notifications: FDA/CFSAN received almost 2000 submissions pursuant to sec. 403(r) (6) of the Act and 21 CFR 101.93(a). Each submission identified the claims being made for one or more products. FDA/CFSAN sent out 47 letters in response these submissions that addressed one or more issues associated with the product and/or the claims being made for it, such as claims contained in the notifications that were outside the scope of section 403(r) (6), of technical deficiencies of the submission, or that products did not appear to be dietary supplements under 201(ff) of the act.
94. Substantiation Guidance: On November 9, 2004, announced in the Federal Register the availability of a draft guidance entitled: "Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act." The draft guidance describes the amount, type, and quality of evidence that FDA recommends a manufacturer have to substantiate a claim under the Act.

    Guidance for Industry - Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act

95. Ephedrine Alkaloids Final Rule: On February 11, 2004, published in the Federal Register (69 FR 6787) a final regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act. This rule became effective on April 12, 2004.

    Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present and Unreasonable Risk (69 FR 6787)

96. Dietary Supplement Enforcement Actions: Sent warning letters to 23 companies asking them to cease distributing products sold as dietary supplements that contain androstenedione and warning them that they could face enforcement action if they do not take appropriate actions.

    Press Release: HHS Launches Crackdown on Products Containing Andro; FDA Warns Manufacturers to Stop Distributing Such Products
    Androstenedione Warning Letters

97. FDA/FTC Actions on Unsubstantiated Claims on Dietary Supplements: On March 17, 2004, FDA announced that Seasilver USA, Inc., and Americaloe, Inc., of Carlsbad, California, and their principals, Bela Berkes and Jason Berkes, signed a consent decree of permanent injunction in which they agreed to stop manufacturing and distributing violative products, including "Seasilver" - a purported cure-all liquid supplement. Seasilver USA marketed their product "Seasilver" as a dietary supplement that the companies promote on the Internet and in marketing materials as a treatment for "over 650" diseases including, for example, cancer, heart disease, stroke, diabetes, hepatitis, arthritis, depression and other diseases.

    These claims cause Seasilver to be an unapproved new drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Such claims also cause Seasilver to be misbranded under the FD&C Act because it lacks adequate directions for use. This action is the culmination of coordinated efforts by FDA and the Federal Trade Commission (FTC).

    Press Release: Dietary Supplement Firms, Seasilver USA, Inc., and Americaloe, Inc., Sign Consent Decree With FDA To Stop Selling Product Claiming To Cure "Over 650" Diseases

Part III: Assuring Food & Cosmetic Safety

Food and Color Additives: Premarket Review

98. Food and Color Additive Petitions - Expedited Review: for the petition receipt cohort of FY 2003, met goal to complete within 360 days of filing, the safety evaluation of two of the three 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.
99. Food and Color Additive Petitions - Non-expedited Review: for the petition receipt cohort of FY 2003, completed within 360 days of filing, the safety evaluation of four (80%) of five food additive petitions that do not qualify for expedited review. This exceeds our goal of completing at least 70% of these petitions within 360 days.
100. Biotechnology Consultations: Completed the scientific evaluation of 6 of 7 (85%) biotechnology consultations within 180 days.
101. GRAS Notifications: Completed the scientific evaluation of 19 of 23 (83%) GRAS notifications within 180 days. CFSAN has accepted and filed 157 GRAS notifications since the initiation of the program.
102. Food Contact Notifications: Completed the review of all Food Contact Notifications within 120-day statutory timeframe.
103. Enforcement: In an effort to increase enforcement actions for dietary supplement-type ingredients in conventional foods whose use is neither approved under section 409 nor generally recognized as safe (GRAS), CFSAN sent letters to companies marketing conventional foods containing "kava" and warning letters were sent to companies marketing products containing "stevia."
104. Prefiling Consultations: Continued to interact with stakeholders proactively by encouraging prefiling consultations for new industry submissions for food and color additive petitions, food contact substance premarket notifications and biotechnology and GRAS consultations. This is evidenced by the successful completion of 64 premarket notification consultations, 12 presubmission meetings with companies submitting food and color additive petitions, 4 presubmission consultation meetings with companies regarding biotechnology products and 10 presubmission consultation meetings with companies regarding GRAS notifications.
105. Guidance for Industry: Issued guidance for industry with five review templates related to the submission of toxicology/safety data submitted in food and color additive petitions and in food contact notifications.

     Guidance for Industry - Templates for Reporting Toxicology Data

Cosmetics

106. Certified Color Additives: CFSAN continued to analyze all batches of color additives and determine certification status (certify or refuse to certify) within an average of 5 working days. The Federal Food, Drug, and Cosmetic Act requires batch certification for all color additives listed in 21 CFR part 74 and for all color additives provisionally listed in 21 CFR part 82.
107. Report to Congress – Color Certification Fees: Senate Report 108-107 of the Agriculture Rural Development, Food and Drug Administration and Related Agencies 2004 Appropriations Language directed FDA to provide a report on the steps that will be taken to ensure that there will not be any future excessive fluctuations in the cost of the Color Certification Program. CFSAN prepared a response to Congress and it is currently under review by the Administration.
108. Improved Tracking and Filing: Completed the development of an electronic tracking and filing system to improve workflow, document tracking, and ease sharing of documents and information within the Office of Cosmetics and Colors (OCAC). Historical and new documents are now being entered into the system.
109. Naming Cosmetic Ingredients: CFSAN's Office of Cosmetics and Colors developed a strategy for amending 21 CFR 701.3(c)(2) to address the outdated sources for naming cosmetic ingredients.
110. Phthalates: Analytical Method: Developed an analytical method for the determination of phthalates in cosmetic products. The method determines phthalates in cosmetic products using high performance liquid chromatography (HPLC). A draft manuscript has been prepared for publication of the method, entitled "Analysis of phthalate esters in consumer cosmetic products." The manuscript will be submitted to the Journal of Cosmetic Science.
111. Phthalates – Survey: Conducted a survey of products to determine the contribution of phthalates to human exposure. CFSAN's Office of Cosmetics and Colors (OCAC) surveyed 48 cosmetic products and identified 5 phthalate esters in 32 of the products. Phthalate levels ranging from 16 ppm to 59,000 ppm were found; the highest levels found were in nail enamels.

Part IV: Assuring Food Safety:
Crosscutting Areas

Science Base

112. Food Safety Goals: In FY 2004, CFSAN established food safety goals to address risks associated with foodborne illnesses. CFSAN staff evaluated risk factors in retail and food service establishments that are related to foodborne illness. Factors that CFSAN will measure in a proposed Food Safety Program Assessment Rating Tool (PART) Goal have been identified. Next step will be to implement a food safety intervention strategy to track progress toward the attainment of the public health food safety goal.
113. Provide training on methods of risk analysis for foods: CFSAN's Staff College sponsored, in conjunction with JIFSAN, a Food Safety Risk Analysis Professional Development Training Program and a Distance Learning Modality program.
114. Human Subject Protection: CFSAN has enhanced its system of protecting human subjects that are undergoing CFSAN related research. These enhancements were established through both a better monitoring system in the Center as well as mandatory training and a web based information package for investigators.
115. Laboratory Quality Assurance System: CFSAN developed a framework for re-engineering the CFSAN Laboratory Quality Assurance System. Implementation of the new system will be complete in FY 2005.
116. Cooperative Agreement between FDA and the University of Mississippi: On September 9, 2003, issued notice of grant award to continue the five-year cooperative research agreement between CFSAN/FDA and the University of Mississippi's National Center for Natural Products Research.
117. FY 2005 Food Survey: Planning for the 2005 Food Safety Survey began in January 2004. One of the first efforts was to invite other interested people from CFSAN and USDA’s Food Safety and Inspection Service to participate in the survey planning. Planning has been completed. The data collection phase of the survey is planned for completion by late summer 2005.
118. Program Effectiveness Conference: On October 29, 2003, A white paper summarizing the results of the: "Working Conference on Measuring the Effectiveness of Foodborne Disease Prevention Programs was completed and presented to CFSAN Management. The conference focused on how to develop meaningful measures that link our regulatory and enforcement actions to public health outcomes. The white paper evaluated mechanisms and methods to measure the effect of FDA's programs on food related health risks. The conference, held on June 30 through July 1, 2003, was attended by public health officials from State Public Health Departments, and the Centers for Disease Control and Prevention, along with key staff from CFSAN and FDA's Office of Regulatory Affairs.
119. Leveraging Activities: Established leveraging activities with the Department of Homeland Security to develop methods for strain attribution of foodborne pathogens.

International

120. Codex Alimentarius Commission: Participated in the 27^th Session of the Codex Alimentarius Commission was held June 28-July 3, 2004, in Geneva, Switzerland. Key accomplishments of this meeting of the Commission included the following:
     • Adoption of more than 25 new Codex standards including: a Code of Practice for Good Animal Feeding; a Code of Hygienic Practice for Milk and Milk Products; Codes of Practice for the prevention and reduction of aflatoxin contamination in peanuts and for lead contamination in food; Guidelines for Nutrition and Health Claims; and, Principles and Guidelines for the Exchange of Information in Food Safety Emergency Situations;
     • Approval of fourteen new work items including: implementing guidance on the Judgment of Equivalence of Sanitary Measures Associated with Food Inspection and Certification; Guidelines on Risk-Based Inspection of Imported Foods (CCFICS); and, revision of the Code of Practice for Foods for Infants and Children.
121. Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU): CFSAN provided the U.S. Delegate and Alternate Delegate to CCNFSDU and attended the Committee's 25^th Session of this Codex Committee. CCNFSDU advanced the Codex Proposed Draft Guidelines for Vitamin and Mineral Food Supplements to Step 5 in the 8-Step Codex Step Procedure. Ongoing work of the Committee includes revision to the Codex Standard for Infant Formula, revision of the Codex Standard for Processed Cereal Based Foods for Infants and Young Children, and the development of Recommendations on the Scientific Basis of Health Claims. CFSAN has provided input to the development of these and other documents under development by the Committee.
122. Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS): CFSAN provided the U.S. Delegate to CCFICS and attended the 12^th Session of this Codex Committee. CCFICS completed work on the Codex Guidelines for the Exchange of Information in Food Control Emergency Situations. Work continues on the subject traceability/product tracing for which CFSAN is providing a leadership role. New work is planned on: implementation guidance for equivalence determinations with respect to sanitary measures; risk-based inspection of imported foods; and revision to guidance on certification of foods, including electronic certification. CFSAN is participating in or is leading the work effort in all these new work areas.
123. Codex Committee on Food Hygiene (CCFH): CFSAN provided the U.S. Delegate and Co-Alternate Delegate to CCFH and attended the 32^nd Session of this Codex Committee. The Committee completed work on the Codex Code of Hygienic Practice for Milk and Milk Products, for which the U.S. was the lead drafting country and CFSAN provided the U.S. lead. The Committee also completed work on definitions for food safety objectives, performance objectives and performance criteria, an area which establishes new international concepts for the area of food hygiene and in which CFSAN played a leading role internationally.

     The Committee has under development a number of important hygiene texts for which CFSAN is providing the Committee lead or leading the U.S. involvement in the Committee's working groups including: Guidelines for Validation of Food Hygiene Control Measures; Principles and Guidelines for Microbiological Risk Management; Guidelines for the Control of Listeria monocytogenes; and the Code of Hygienic Practice for Eggs and Egg Products.

124. Codex Committee on Methods of Analysis and Sampling (CCMAS): CFSAN provided the U.S. Delegate to CCMAS and attended the Committee's 25^th Session. The Committee completed work on Codex General Guidelines for Sampling and Guidelines on Measurement of Uncertainty. The Committee initiated consideration of the handling of methods for the detection of foods derived from modern biotechnology and continued work on other topics including Guidelines for Evaluating Acceptable Methods of Analysis. The Committee also carried out its endorsement of analytical procedures appearing in Codex commodity standards.
125. Codex Committee on Fish and Fishery Products (CCFFP): CFSAN provided the U.S. Delegate to CCFFP and attended the Committee's 26^th Session. The Committee completed work on sections of the Code of Practice for Fish and Fishery Products dealing with Aquaculture and Quick Frozen Coated Products; work continues on other sections of the Code. Work also continues on a model health certificate to accompany export shipments of fish and on various fish standards. U.S., and particularly, CFSAN input has been significant in all of this work.
126. Codex Committee on Food Additives and Contaminants (CCFAC) : CFSAN provided the U.S. Delegate and Alternate delegate to CCFAC and attended the Committee's 36^th Session. The Committee completed work on Risk Analysis Principles for use of the Committee in its work on food additives and contaminants, a document for which the United States was the lead drafter. With respect to food additives, the Committee continued to progress work on the General Standard for Food Additives, endorsed additive provisions in various Codex Commodity standards, and considered how best to handle processing aids. With respect to contaminants, the Committee completed work on: an initial section of the General Standard for Contaminants and Toxins in Foods; a Policy for Exposure Assessment of Contaminants and Toxins in Foods or Food Groups; the Code of Practice for the Prevention and Adulteration and Reduction of Aflatoxin Contamination in Peanuts; and the Code of Practice for the Prevention and Reduction of Lead Contamination in Foods.
127. Codex Committee on General Principles (19^th (Extraordinary) (CCGP)): CFSAN attended the 19^th (Extraordinary) Session of CCGP that dealt with recommendations resulting from the evaluation of Codex by WHO and FAO. Significant recommendations were made relating to improved management of the Codex standards setting process; the governance of Codex, including the structure and function of the Codex Executive Committee and establishing annual sessions of the Codex Alimentarius Commission; and in the operation of Codex Committees and Task Forces.
128. Codex Committee on Food Labeling (CCFL): CFSAN provided the U.S. Delegate to CCFL and attended the 32^nd Session of the Committee. The Committee completed work on the Codex Guidelines for the Use of Nutrition and Health Claims. Discussions continued on approaches to the labeling of foods derived from modern biotechnology, an area in which countries hold significantly different views and in which the CFSAN has provided significant leadership both within the United States and within Codex. The Committee agreed to undertake a discussion on the appropriateness of developing guidance on advertising with the context of Codex.
129. Codex Committee on Milk and Milk Products (CCMMP): CFSAN provided the U.S. Alternate Delegate to CCMMP and attended the 6^th Session of the Committee. The Committee advanced a number of dairy product standards to Step 5 in the 8 Step Codex Step Procedure (including those for cheddar cheese, whey cheeses, and various dairy fat blends) and continued work on several other dairy product standards. The Committee considered the subject of geographic indicators with respect to the development of a standard for parmesan cheese, an issue on which guidance was requested from the Codex Alimentarius Commission.
130. Codex Committee on General Principles (20^th Session)(CCGP): CFSAN provided the U.S. Alternate Delegate to the 20^th Session of CCGP. The Committee completed work on a definition for traceability/product tracing, an area in which CFSAN has provided leadership, both domestically and internationally. The Committee also forwarded definitions of food safety objectives, performance objectives and performance criteria for use with respect to food hygiene to the Commission for adoption on an interim basis. Work progressed on the development of: proposed Working Principles for Risk Analysis for Food Safety; a revision to the Codex Code of Ethics; guidelines on cooperation with international intergovernmental organizations; and principles and policies for the participation of international non-governmental organizations and observers in Codex.
131. Technical Working Group for Food Labeling, Packaging and Standards: The Technical Working Group (TWG) on Food Packaging, Labeling and Standards held its annual meeting in Washington, D.C., on April 13 and 14. The group discussed a number of important issues, such as FDA's Obesity Initiative, nutrition labeling and claims, trans fatty acid labeling, allergen labeling and legislation, food standards, infant formula, and food safety-related labeling statements and claims. In addition, the meeting participants identified several items for further follow-up as well as areas for potential harmonization. This TWG meeting also served as a forum for developing and discussing mutual approaches on labeling issues that were put forward at the 32^nd Session of the Codex Committee on Food Labeling, which was held on May 10-14 in Montreal, Canada.
132. Trade Negotiations: CFSAN participated in United States trade negotiations to draft the sanitary and phytosanitary articles of the agriculture chapters of the Central American Free Trade Agreement (CAFTA) including Morocco, Australia, Bahrain, Dominican Republic, Panama and Thailand.

Food Biotechnology

133. Outreach to Stakeholders: As part of CFSAN's effort to enhance the information provided to the public in FDA's evaluation of foods derived from bioengineered plants, an updated web page was developed which shows the list of biotechnology consultations that CFSAN has completed.

     List of Completed Consultations on Bioengineered Foods

     CFSAN's Office of Food Additive Safety has conducted outreach activities to interested stakeholders. This includes individuals and groups from foreign governments, industry groups, consumer interest groups, and academics. In the period from January-May, 2004, CFSAN has held 13 meetings in order to explain to the public FDA‘s policy for evaluation bioengineered crop plants.

134. Food biotechnology Subcommittee Meeting: On September 24, 2003, CFSAN held the second meeting of the Food Biotechnology Subcommittee of the Food Advisory Committee, in Washington, D.C. The subcommittee was asked to consider the use of molecular biology data and information for assessing the safety of new bioengineered foods and to provide suggestions to FDA on any new developments that might enhance the agency's evaluation of these foods. The subcommittee generally supported the new Codex guidelines and FDA's current approach that emphasizes ensuring that new substances in food are safe for consumers.
135. Guidance: Developed 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:

Internal Processes

136. CFSAN Adverse Events reporting System (CAERS): CFSAN now tracks, evaluates, and monitors all adverse events and consumer complaints received about CFSAN regulated food and cosmetic products.
137. New Data Sources: Identified three data sources to obtain exposure and other missing data on dietary supplements and other CFSAN-regulated products. The data sources are: (1) the Slone Survey, (2) the Behavioral Risk Factors Surveillance Study (BRFSS) and (3) the American Association of Poison Control Centers (AAPCC). Data collection from each source is underway.
138. LACF Electronic Registration: In September 2004, pursuant to the Governmentwide Paperwork Reduction Act (GPEA), CFSAN implemented "eLACF" (electronic submission capability for Low Acid Canned Foods). "eLACF" gives all low-acid and acidified food processing establishments the option to register their firm with FDA electronically under the new FDA Unified Registration and Listing System (FURLS).
139. CFSAN Risk Management Framework: On February 5, 2004, completed CFSAN's Risk Management Framework. Risk management is the process of weighing policy alternatives and implementing appropriate control options, including regulatory measures. CFSAN's risk management framework builds upon this foundation and includes how projects are identified, prioritized, completed and procedures for monitoring and re-evaluating outcomes of the decisions. The seven components of the CFSAN Risk Management Framework are trigger/inputs, prioritization, process, decision, implementation, outcome, and monitor/evaluate/modify. Training on implementation of the Risk Management Framework for CFSAN management and staff is underway.

Focused, Economic-based Regulations

140. Report to Congress – Standards of Identity for Yogurt: House Report 108-193 of the Agriculture Rural Development, Food and Drug Administration and Related Agencies 2004 Appropriations Language directs FDA to brief the Appropriation Committee on the comments received and on Agency plans to issue a proposed rule on the standards of identity for yogurt. CFSAN prepared a response to Congress and it is currently under review by the Administration.
141. Report to Congress – Unfiltered Milk and Milk Protein Concentrate: House Report 108-193 and Senate Report 108-107 of the Agriculture Rural Development, Food and Drug Administration and Related Agencies 2004 Appropriations Language directs FDA to provide regular reports on the status of its review of any petitions to use ultrafiltered milk, casein or MPC in dairy products that have standards of identity. CFSAN prepared a response to Congress and it is currently under review by the Administration.

EEO/Diversity Initiatives

142. EEO/Diversity Accomplishments: In FY 2004, CFSAN's Staff College met with members of each Special Emphasis Group in CFSAN and with Center managers to determine training, education, and development needs. Our Staff College also explored other opportunities for raising cultural awareness, appreciating diversity and fostering an inclusive environment in CFSAN. Listed below are activities and events representing a continuation of the Center's past practices to support EEO and Diversity.
     
     1. CFSAN's EEO office was consolidated and moved to a central location under FDA's new Office Shared Services.
     2. CFSAN held six workshops on conflict prevention and resolution for center managers.
     3. Several Special Emphasis Groups in the Center put on cultural awareness programs for Black History Month, Asian-American Pacific Islanders Month, and Hispanic Heritage Month.
     4. CFSAN participated in the Emerging Leaders Program (ELP) - This is a DHHS recruitment program for students who have post-baccalaureate degrees in the sciences. Participants receive extensive training the first year, and are given specific experience within a Center/office the second year. Staff College works with Personnel and the program offices in CFSAN to represent the Center at a yearly career fair, identify potentially suitable matches, and facilitate entry on duty for participants coming to CFSAN.

        CFSAN also participates annually in the Minorities in Science and Technology (MIST) Career Fair. Our Staff College partnered with BIG (Blacks in Government), Black Male Focus Group and the Hispanic Initiative to achieve diverse Center representation.

Management Initiatives

143. FY 2004 Budget Review: The budget review for FY 2004 is complete and all priority funding needs have been identified.
144. Decommissioning of FB-8: Continued the decommissioning effort of the Federal Building 8 facility, all of the radioactivity surveys were completed in October 2004 and a final report to the Nuclear Regulatory Commission (NRC) will be sent by December of 2004. The majority of the chemical decommissioning is complete. The last part, mercury removal from laboratory drain lines, is subject to the GSA construction schedule.
145. University Station: Construction of the new CFSAN adjunct building: "University Station" is complete. CFSAN's Office of Food Additive Safety formally located on Vermont Avenue in Washington, D.C. and CFSAN's Office of Cosmetics and Color, formally located in Chantilly, Virginia will begin their move to University Station in November 2004.
146. Realign OMS: CFSAN's Office of Management Systems (OMS) has been realigned to reflect the establishment of FDA's Office of Shared Services. OMS now focuses on delivering efficient and effective services that do not duplicate those offered at the Agency level but rather complement shared services and fully meet the CFSAN user community's needs.
147. Shared Services Implementation: With the advent of the Agency's Office of Shared Services, CFSAN has established, within the OMS, a Shared Services Liaison Group. This group is responsible for establishing service level agreements and monitoring services provided by the Agency's Office of Shared Services to ensure that the CFSAN user community is receiving the necessary administrative and information technology services critical to the Center's mission. This liaison group has become the "consumer advocate" for the CFSAN user community.
148. Laboratory Security: CFSAN has implemented programs and policies to ensure full security over select agents used within CFSAN. All applicable laboratories are electronically secured with limited access and the research facility at Muirkirk road is a fully secure location.
149. The President's Management Agenda: CFSAN personnel focused on 2 major initiatives in FY 2004 as part of the President's Management Agenda. The first is a-76 Implementation. The Center completed all the work necessary to support the Agency's issuance of a Performance Work Schedule (PWS) for clerical and administrative support services. The 2^nd initiative is the Unified Financial Management System (UFMS). The Center is playing an active role in implementation of this system.
150. NTEU: This year has been a productive one for the Labor-Management relationship within CFSAN. The Cooperation Council has met on a regular schedule and successfully handled such matters as Quality Step Increases (QSIs), Student loan repayments, joint management - labor training and fuller implementation of the bargaining unit contract. NTEU has worked in full partnership with CFSAN management to ensure a smooth move of the Office of Food Additive Safety and the Office of Cosmetics and Colors into the new University Station building. NTEU has assisted in office assignments, furniture selections and move planning for University Station.
151. Leadership Legacy: On September 27, 2004, the report of the CFSAN Leadership Legacy Steering Committee was completed. The Leadership Legacy Initiative was established to address the significant and unprecedented number of leaders and managers at all levels of the center who are eligible to retire in the next five to ten years. The steering committee charge prepared a report that takes a careful look at the subject of leadership development in CFSAN, and outlines a series of recommendations and action items that CFSAN will use as a template and framework for further developing the Leadership Legacy Program at CFSAN.