U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
February 3, 2000

As promised, I am pleased to provide you with an end-of-the-year "Report Card" on our 1999 program priority accomplishments for FDA's foods program. These are the "boulders" we pledged to move up and over the mountain top. As you will see, we completed nearly 90% of our "A" list goals (73 out of 83 activities). I am very proud of this success rate. This represents a clear management strategy to focus our resources on where we provide the most benefit to American consumers.

Implementation of the President's Food Safety Initiative, the Center's top priority, constitutes the Centerpiece of our 1999 accomplishments. Of particular note is the Presidential radio address on December 11 which announced the Egg Safety and Imported Food Action Plans. After food safety, our 1999 accomplishments include important advances in such areas as food additives, dietary supplements, food labeling, cosmetics and international activities. Twenty areas of particular note have been highlighted for you.

Last fall, I wrote to you about our declaring a "New Day" at CFSAN, and about our broader vision of building a "World Class Organization." The dedication of the many FDA staff who embraced the concept of the 1999 workplan and who worked diligently to complete nearly 90% of our goals demonstrates that we are, indeed, on our way to reaching that goal. I am also pleased to tell you that our 2000 Program Priorities document will be available in the coming weeks. The format of the 2000 workplan will be similar to the 1999 workplan, except it will be a nine-month plan (through September 30, 2000) so as to align our program priorities with the federal budget cycle.

In closing, I very much appreciate the support I have received from many stakeholders on this management approach. I look forward to continuing this tradition of building predictability, productivity and accountability into our Foods program. The American public deserves no less.

Imports: Improved the safety of imported food products by enhancing border surveillance and greatly expanding FDA's overseas presence. At the border, FDA initiated a 1,000 sample survey of high volume fresh produce imports. Overseas, FDA doubled the number of foreign food establishment inspections, conducted fiveassessments of foreign food safety systems, and provided extensive education and technical assistance on use of the Good Agricultural Practices/Good Manufacturing Practices guidance for produce.

Imported Foods Action Plan: As announced by President Clinton in his December 11, 1999 radio address, FDA and the U.S. Customs Service developed an Imported Foods Action Plan to further enhance border surveillance. The Plan will be implemented in 2000.

Seafood HACCP Inspections: FDA conducted the second year of seafood HACCP inspections, with priority to processors with implementation problems. FDA found clear progress by most seafood processors, but also issued warning letters to those firms with significant, unaddressed deficiencies.

Sprouts: CFSAN issued two guidance documents to enhance the safety of sprouts, including guidance for microbiological testing.

Prevention Measures for Eggs: CFSAN published a proposed rule that would require refrigeration of shell eggs at retail and safe handling statements on labels of shell eggs.

Egg Safety Action Plan: In collaboration with USDA, EPA and the Department of Commerce, FDA completed an Egg Safety Action Plan that identifies the systems and practices that need to be implemented to sharply reduce eggs as a source of human Salmonella enteritidis illnesses. The Plan was announced by President Clinton in his December 11, 1999 radio address, and implementation will begin in 2000.

Risk Assessments: Completed, with public input, draft risk assessments for Listeria and Vibrio parahaemolytics. Final risk assessments will be completed in 2000.

Food Code: CFSAN completed revisions to the Food Code to enhance the safety of food prepared outside the home, including restaurants, nursing homes, hospitals, and day care centers. The Food Code was adopted by agencies in 15 states.

Expedited Review: CFSAN developed and implemented new procedures to expedite the review of food additives that are intended to decrease the incidence of foodborne illnesses through their antimicrobial actions against human pathogens that may be present in food. CFSAN approved four antimicrobial agents which had been designated for expedited review -- three sodium chlorite solutions and one peroxyacetic acid solution.

Trans Fatty Acids: CFSAN published a proposed rule to require that the amount of trans fatty acids in food be included in the Nutrition Facts panel.

Infant Formula: CFSAN reviewed all 35 notifications for infant formulas within statutory timeframes.

New Dietary Ingredients: CFSAN reviewed all 24 notifications for new dietary ingredients within statutory timeframes.

Health Claim/Nutrient Content Claim Petitions and Notifications: CFSAN responded to these submissions within statutory timeframes and use of two health claims were authorized: (1) The relationship between whole grain foods and heart disease and certain cancers; and (2) The role of soy protein in reducing the risk of coronary heart disease.

Dietary Supplement Overall Strategy: CFSAN developed an overall strategy to fully implement the Dietary Supplement Health and Education Act of 1994. Once implemented, this science-based plan is intended to provide a high level of consumer confidence in the safety, composition and labeling of dietary supplement products.

Strategy for Pearson Court Decision: CFSAN informed the public of its strategy to implement the court decision in Pearson v. Shalala. As part of this strategy, CFSAN developed guidance for the industry clarifying the meaning of the "significant scientific agreement" standard as it applies to the review of scientific data for health claims.

Biotechnology Public Meetings: Three meetings were held to give the public an opportunity to provide comments on CFSAN's process for assuring the safety of food produced through biotechnology. In 2000, CFSAN will develop and implement strategies based on these public meetings.

National Food Safety System: In collaboration with CDC, USDA, and state and local governments, continued progress was made towards development of a plan for a national food safety system. Long-term planning ideas will be integrated into the strategic planning process being conducted by the President's Council on Food Safety.

International Affirmative Agenda: CFSAN published its Affirmative Agenda for International Activities for 2000 – 2002. The Agenda addresses broad priorities in five major international activities: Regulatory; Harmonization; Development, Maintenance and Dissemination of CFSAN's Science Base; Equivalence Evaluations, Food Safety Needs Assessments, and Food Safety Technical Cooperation and Assistance; and Trade-Related Activities.

Cosmetics Voluntary Registration Program: Reinstated the Cosmetics Voluntary Registration Program, utilizing restoration funds provided in the FY 99 Appropriations.

"New Day": CFSAN implemented a "New Day" initiative to improve the quality of worklife for all employees. This initiative provides the foundation for CFSAN building itself into a World Class Organization.

Items marked with ** were accomplished in the 4^th quarter.

Imports

1. Enhance follow-up and containment of foodborne disease outbreaks associated with imported food: CFSAN and Office of Regulatory Affairs (ORA) have developed and implemented the publication; "Guide to Traceback of Fresh Fruits and Vegetables Implicated in Epidemiological Investigations." In conjunction with the publication of this document, three satellite training courses for FDA and State/Local investigators e.g., Food Microbiology (3-day), Foodborne Disease Epidemiology (3-days), Tracebacks (2-days) have been conducted. These training courses were attended by over 10,000 participants. An extensive "Farm Investigation Questionnaire" for use on farms implicated in produce tracebacks has also been developed.

2. Increase surveillance of imported food products at the border: CFSAN and ORA initiated a 1000 sample survey of high volume imported fresh produce. These commodities were analyzed for Salmonella, Shigella, and E. coli O157:H7. Of the first 500 samples, approximately 5% tested positive for bacteria. CFSAN and ORA conducted 19 traceback investigations and visited 10 farms as the result of outbreak tracebacks or positive samples in the Imported Produce Sampling Program.
3. ** Imported Foods Action Plan: As announced by President Clinton in his December 11, 1999 radio address, FDA and the U.S. Customs Service developed an Imported Foods Action Plan to further protect consumers from unsafe imported food. The Plan includes actions that FDA and Customs will take to: (1) prevent distribution of imported unsafe food by means such as requiring food to be held until reviewed by FDA; (2) destroy imported food that poses a serious public health threat; (3) prohibit the re-importation of food that has been previously refused admission, and require the marking of shipping containers of imported food that is refused admission for safety reasons; (4) set standards for private laboratories for the collection and analysis of samples of imported food for the purpose of gaining entry in the U.S.; (5) increase the amount of the bond posted for imported foods when necessary to deter premature and illegal entry into the U.S.; and (6) enhance enforcement against violations of U.S. laws related to the importation of foods, including through the imposition of civil monetary penalties.

4. Initiate education/outreach and technical assistance to foreign countries on the use of Good Agricultural Practices (GAP)/Good Manufacturing Practices (GMP) guidance for produce: A new tool to help explain the Produce Safety Initiative was completed: "Assuring Safer Produce: A Global Issue," a six-minute video that provides an overview of the good agricultural and good manufacturing practices, is available in English, Spanish, French and Portuguese.

   CFSAN/JIFSAN held an international conference, "Enhancing the Safety of Fresh Produce at the Source: Training Modalities and Methods, Needs and Opportunities". This landmark workshop was attended by 175 participants from 24 countries. The workshop began the process for determining how to develop an education and outreach program for growers and producers that will benefit public health and the market place.

   FDA held two international meetings for government officials and food producers with food safety responsibilities. The first, targeted to countries of North and Central America, was held in Mexico City; and the second, targeted to countries of South America, was held in Santiago, Chile.

5. Evaluate food regulatory systems in foreign countries: CFSAN, ORA, and other FDA staff conducted an assessment of the food safety systems in Nicaragua, Costa Rica, El Salvador, Guatemala and Honduras.
6. Conduct 75-100 foreign inspections of food establishments: CFSAN and ORA completed 82 foreign inspections in FY 1999 of food plants (78) and farms (4) that produce food products at high risk of microbial contamination. Of the first 26 Establishment Inspection Reports (EIRs) reviewed: eight establishments were placed on DWPE (Detention Without Physical Examination) because of unsanitary conditions; four establishments were issued warning letters; and fourteen establishments were in compliance with FDA regulations. Review of the remaining EIR's is ongoing.

Hazard Analysis and Critical Control Points (HACCP)

7. ** Seafood HACCP Inspections: FDA conducted the second year of rigorous seafood HACCP inspections, with priority to processors with implementation problems. FDA inspectors evaluated the adequacy of HACCP plans for 11 types of hazards, ranging from pathogens and histimines to use of unlawful pesticides and food additives. Based on data available at the end of calendar year 1999, FDA found clear progress being made by most seafood processors. FDA will issue a second year "progress report" once more detailed information is available.

8. ** Seafood HACCP Enforcement Strategy: CFSAN and ORA developed and implemented an enforcement strategy for the second year of HACCP inspections. The enforcement strategy was embodied in the Compliance Program for the FDA foods program. Based on data available at the end of calendar year 1999, FDA issued warning letters to approximately 5% of seafood firms.

9. ** Seafood HACCP Training: In collaboration with the Seafood HACCP Alliance, CFSAN developed a follow-on training program for seafood processors. Unlike the original course for processors in basic HACCP, which stressed fundamental concepts and HACCP theory, this course focused on practical problem solving and was based on problems that processors were found to be having in implementing their HACCP systems. Over 20 courses were taught around the country, attended by over 300 seafood industry representatives.

10. ** Seafood HACCP Government Performance and Results Act (GPRA) Goal: The GPRA goal for FY 99 was to have 50% of the seafood industry operating adequately under appropriate HACCP systems. Data available through the end of calendar year 1999 indicates that the GPRA goal was exceeded by approximately 5 percent.

11. ** Seafood HACCP "Transition" Policy: CFSAN published a draft "transition" policy for public comment on March 26, 1999 (64 FR 14736). The draft policy describes when scientific issues need to be resolved before FDA will take regulatory action against a processor that has deficiencies in their HACCP system. The final policy is expected to be published in the first quarter of 2000.

Produce Initiative

12. Good Agricultural Practices: In conjunction with USDA, CFSAN disseminated and promoted the use of the Good Agricultural Practices/Good Manufacturing Practices guidance document to both domestic and foreign agriculture communities. This guide has been translated into three languages: Portuguese, French, and Spanish.

13. ** Sprouts: On October 25, 1999, CFSAN issued two guidance documents to enhance the safety of sprouts. The guidance advises sprout producers and seed suppliers of steps they should take to reduce microbial hazards common to sprout production. A companion guide provides producers with the latest information about testing spent irrigation water, an important step to ensure the safety of sprouts.

Additional Prevention Efforts

14. ** Citrus Juices: In conjunction with the Florida Department of Citrus, the State of California and the National Center for Food Safety and Technology, CFSAN developed guidance to help the industry develop practical means for achieving the FDA-required reduction in pathogens (100,000 fold or 5-log) in lieu of the labeling requirement. This included conducting pilot HACCP programs, developing new microbiological methods, evaluating new technologies under commercial conditions and developing tools that industry could use to evaluate the effectiveness of their programs. CFSAN conducted a series of workshops to ensure that the information was adequately disseminated to the citrus industry.

15. Preventive Measures for Eggs: On July 6, 1999, CFSAN published a proposed rule that would require refrigeration of shell eggs at retail and safe handling statements on labels of shell eggs (64 FR 36491).

16. Status Report on Eggs: In conjunction with USDA, and in accordance with the Appropriations Conference Report, a status report on actions taken to enhance the safety of shell eggs and egg products was submitted to Congress on March 16, 1999.

17. Food Code: Revisions to the Food Code were completed and a notice of its availability was published in the Federal Register on February 22, 1999 (64 FR 8576). Agencies in 15 states have adopted the Food Code. This exceeds the FY 99 Government Performance and Results Act (GPRA) goal to achieve adoption of the Food Code by 25 percent of States.

18. MOU with FSIS: A Memorandum of Understanding (MOU) with the Food Safety and Inspection Service (FSIS) regarding food establishments under the jurisdiction of both FDA and FSIS was finalized on March 1, 1999.
19. Vibrio vulnificus: In the Federal Register of January 21, 1999 (64 FR 3300), CFSAN published a notice soliciting comments on citizen petition 98P-0504 requesting that FDA establish a performance standard for Vibrio vulnificus.

Surveillance and Outbreak Response

20. Outbreak Response: A document describing the decision-making criteria for handling outbreaks has been developed. This document will help CFSAN, in conjunction with the field, follow-up and contain foodborne disease outbreaks associated with domestic food.
21. Foodborne Outbreak Response Coordinating Group (FORC G): Under FORCG, HHS and USDA are in the process of refining, with States, the uniform procedures developed for all agencies to follow in coordinating outbreak investigations. In regards to this effort, CFSAN, in conjunction with the field, USDA, AFDO and others, developed a document entitled: "Foodborne Outbreak Response and Coordination." This document is intended to guide Federal agencies, State or local health officials, and state food regulatory officials involved in food or waterborne outbreaks on procedures for coordinating responses to a multi-state outbreak of food or waterborne illness.
22. Listeria: A questionnaire has been developed to conduct, through CDC and the FoodNet sites, a case-control study of Listeria infections to guide control efforts.
23. ** Salmonella enteritidis (SE): In collaboration with USDA, EPA and the Department of Commerce, FDA completed an Egg Safety Action Plan that was announced by President Clinton in his December 11, 1999 radio address. The Action Plan identifies the systems and practices that need to be implemented to sharply reduce eggs as a source of human SE illnesses.

Research

24. Food Safety Initiative Research and Risk Assessment: CFSAN conducted food safety research as outlined in the Center's "Three-Year Plan for Research in Support of the National Food Safety Initiative and the Produce and Imported Food Safety Initiative." In addition, a review of the research projects and a plan update is complete.

25. Extramural Research: Second year funding for the multi-year grants awarded in fiscal year 1998 is complete. Project officers for each of the grants completed the extramural project reviews to obtain a status and update for the project.

26. ** Consultation with USDA: CFSAN worked closely with USDA to develop Requests for Proposals (RFPs) for USDA's Special Research Grants Program and the Epidemiological Approaches for Food Safety Program, pursuant to the $5 million identified in the FY 99 Agriculture Appropriations Bill. CFSAN's research needs were presented in the RFPs, and a broader listing of needs was communicated in a letter to USDA.

27. ** Joint Institute for Food Safety Research (JIFSR): In conjunction with USDA, a final report articulating the concept of JIFSR, a proposed structure, operating principles, goals and outcomes, and an implementation schedule was developed and transmitted to the President on July 2, 1999.

Risk Assessment

28. ** Listeria: To aid in conducting a risk assessment of listeria in ready-to-eat foods, a notice was published requesting the submission of scientific data and information (May 26, 1999, 64 FR 28351). In addition, in conjunction with the Risk Assessment Working Group of the National Advisory Committee on Microbiological Criteria for Foods, public meetings were held on May 26 and September 23, 1999 to provide an opportunity for open discussion of the risk assessment of Listeria. Subsequently, CFSAN completed a draft risk assessment which was sent to the Risk Assessment Consortium for review. The final risk assessment will be completed in 2000.

29. ** Vibrio Parahaemolyticus: To aid in conducting a risk assessment of Vibrio parahaemolyticus in shellfish, a notice was published requesting the submission of scientific data and information (May 7, 1999, 64 FR 24664). In addition, in conjunction with the Risk Assessment Working Group of the National Advisory Committee on Microbiological Criteria for Foods, public meetings were held on May 26 and September 24, 1999 to provide an opportunity for open discussion of the risk assessment of Vibrio parahaemolyticus. Subsequently, CFSAN completed a draft risk assessment which was sent to the Risk Assessment Consortium for review. The final risk assessment will be completed in 2000.

30. ** Methylmercury: CFSAN completed a draft risk assessment of methylmercury based on a subset of data from two key studies. CFSAN will finalize this risk assessment in 2000, as well as develop an overall risk assessment of methylmercury in seafood incorporating new data expected to be available in the Spring of 2000.

Education

31. Shell Eggs Education Campaign: A specialized "egg safety" campaign was developed in an effort to reduce the incidence of foodborne illnesses caused by Salmonella enteritidis. Two easily reproduced fact sheets were developed: "Playing it Safe with Eggs" for consumers and "Assuring the Safety of Eggs" for food service personnel. A news article was written in English and Spanish and distributed to small dailies, weeklies and local advertisement-type publications.

32. "Fight BAC!": In conjunction with the Public-Private Partnership for Food Safety Education, food safety education efforts targeted to school children and high risk population -- i.e., the very young, the elderly, and those with impaired immune systems -- have been initiated.

33. Food Safety Education Month: The President's Council on Food Safety issued a proclamation declaring September 1999, National Food Safety Education Month. This was an opportunity to promote food safety to consumers and the food industry. This year's theme was "Cook It Safely." FDA, in conjunction with USDA, developed and mailed consumer education planning guides to public health departments, FDA public affairs specialists and USDA extension agents throughout the country. The guide contained reproducible activities and publicity ideas for food safety education during September. In addition, special mailings were sent to over 100,000 food service directors for at-risk audiences, school food service directors, day care directors and nursing home food service directors with special information about food safety.

Strategic Planning

34. ** President's Council on Food Safety: CFSAN participated in the President's Council for Food Safety Strategic Planning Task Force activities to develop a comprehensive Food Safety Strategic Plan. A public meeting was held on July 15, 1999 to solicit comments from consumers, industry and academia, as well as state and local officials. Using input received from the public meeting, the Task Force prepared a Draft Preliminary Strategic Plan and published a summary in the Federal Register (December 15, 1999, 64 FR 70167), leading up to a second public meeting on January 19, 2000. CFSAN will continue to participate in the Council's activities to finalize the comprehensive Strategic Plan by July 2000.

Premarket Review of Food Ingredients

35. Expedited Review: New procedures have been implemented to expedite the review of food additives that are intended to decrease the incidence of foodborne illnesses through their antimicrobial actions against human pathogens that may be present in food. Guidance on implementation of the expedited review process was published in the Federal Register on January 5, 1999 (64 FR 517). In 1999, CFSAN approved food additive petitions for four antimicrobial agents which had been designated for expedited review -- three sodium chlorite solutions and one peroxyacetic acid solution.

36. ** Food and Color Additives: CFSAN exceeded the GPRA performance goal to complete 30% of food and color additive petitions within 360 days. Specifically, for petitions received in FY 98, 54% were completed within 360 days. This cohort of food and color additive petitions was larger than any received in the past decade. Because of the large number of new petitions, less progress was made in reducing the number of overdue petitions than initially projected. Specifically, at the end of the fiscal year, 42% of the petitions under review were overdue (goal was 30 percent).

37. ** Indirect Additives (Food Contact Substances): On November 22, 1999, CFSAN issued two guidance documents for the industry on the submission of premarket notifications for food contact substances, incorporating feedback from a public meeting held in March 1999. Full implementation of this program will be initiated in 2000 as a result of new resources made available in the FY2000 Congressional appropriations.

38. Irradiation Labeling: An advanced notice of proposed rulemaking to solicit comments on whether revisions on the current irradiation labeling requirements are needed published in the Federal Register on February 17, 1999 (64 FR 7834).

39. Food Quality Protection Act: On July 27, 1999, CFSAN announced the availability of a guidance document entitled "Antimicrobial Food Additives – Guidance" (64 FR 40612). This document is intended to clarify FDA's jurisdiction over antimicrobials that are used in or on food, including those used in or on edible food, in water that contacts edible food, and those used in the manufacture of, or in or on, food-contact articles, subsequent to the enactment of the Food Quality Protection Act of 1996 (FQPA), and the Antimicrobial Regulation Technical Corrections Act of 1998 (ARTCA).

Nutrition, Health Claims and Labeling

40. ** Trans Fatty Acids: In the Federal Register of November 17, 1999 (64 FR 62745) a proposal was published to amend regulations on nutrition labeling to require that the amount of trans fatty acids in a food be included in the Nutrition Facts panel.

41. ** Infant Formula Premarket Notifications: CFSAN received 35 new infant formula notifications, and all were reviewed within the 90-day statutory timeframe.

42. ** Nutrient Content/Health Claim Notifications Based on an Authoritative Statement: CFSAN received one health claim notification based on an authoritative statement. The petition was reviewed within the 120-day statutory timeframe, and use of a health claim was authorized about the relationship between whole grain foods and heart disease and certain cancers.

43. ** Nutrient Content/Health Claim Petitions: CFSAN received five nutrient content/health claim petitions and all five were responded to within statutory timeframes. One of these petitions was approved in a final rule published in the Federal Register on October 26, 1999 (64 FR 57700) that authorized the use of a health claim about the role of soy protein in reducing the risk of coronary heart disease.

44. Citizen Petition: As directed in the Appropriations Conference Report, FDA responded to citizen petition 98P-0968 regarding the labeling of Surimi through publication of a proposed rule to amend the ingredient labeling regulations on April 9, 1999 (64 FR 17295).
45. Surimi Final Rule: In the Federal Register of September 17, 1999 (64 FR 50445 ), CFSAN published a final rule to amend its ingredient labeling regulation to permit the use of "and/or" labeling for the various fish species used in the production of processed seafood products, i.e., surimi and surimi-containing foods. This rule will permit manufacturers of surimi and surimi-containing products to maintain a single label inventory identifying all of the fish species that may be used in the manufacture of the surimi product. This action responds to petition 98P-0968 submitted by the National Fisheries Institute (NFI) requesting more flexible ingredient labeling for the fish ingredients used in the production of surimi products.
46. Food Regulatory Report: As directed in the Senate Appropriations Report, a report to Congress regarding the Agency's performance on various applications, notifications, submissions, petitions, and requests for advisory opinions was submitted to Congress on April 21, 1999.

Dietary Supplements

47. ** New Dietary Ingredients: CFSAN received 24 notifications for new dietary ingredients and all were reviewed within the 75-day statutory timeframe.

48. Nutrient Content/Health Claims Proposal: A proposed rule on the applicability to dietary supplements of the FDAMA provisions on nutrient content/health claim notifications based on an authoritative statement was published in the Federal Register on January 21, 1999 (64 FR 3250).

49. ** Overall Strategy: CFSAN developed an overall strategy for achieving effective regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994. The strategy addresses six broad areas: safety, labeling, boundaries, enforcement activities, science-base, and outreach. A copy of this ten-year plan is available on CFSAN's home page (www.cfsan.fda.gov).

50. ** Stakeholder Outreach: CFSAN held five stakeholder meetings in 1999 to provide an opportunity for public input into various dietary supplement issues. Two meetings focused on development of the overall strategy; one meeting addressed structure/function claims; and three meetings focused on good manufacturing practices regulations. In addition, CFSAN revised and expanded its web site for dietary supplements and established a database of stakeholders to facilitate outreach. Lastly, FDA visited seven dietary supplement manufacturers to learn about their quality control and good manufacturing practices.

51. ** Strategy for Pearson Court Decision: In the Federal Register of December 1, 1999 (64 FR 67289), CFSAN informed the public of its strategy to implement the court decision in Pearson v. Shalala. In the notice, CFSAN also announced its intent to hold a public meeting in the first quarter of 2000.

52. ** Guidance on Significant Scientific Agreement: As part of the Pearson strategy, CFSAN developed guidance for the industry clarifying the meaning of the "significant scientific agreement" standard as it applies to the review of scientific data for health claims. A notice of availability of this guidance document was published in the Federal Register on December 22, 1999 (64 FR 71794.)

53. Citizen Petition: A response to citizen petition 98P-0509 regarding FDA's jurisdiction over publications associated with dietary supplements was issued on April 9, 1999.

Chemical and Other Contaminants

54. Pesticide Monitoring Improvements Act (PMIA): FDA's pesticide monitoring data and summary information was made available on the internet, as required by PMIA, on March 31, 1999.
55. Total Diet Study Workshop: An international workshop was convened in Kansas City, Missouri from July 25 through August 6, 1999, under the auspices of FDA (CFSAN & ORA) and the World Health Organization (WHO). The focus of the workshop was to discuss all aspects of total diet studies (TDS) with those countries which have TDS and to assist those countries which don't have TDS, particularly with developing countries in their efforts to establish dietary monitoring systems for contaminants, pesticides, and nutritional elements in their food supplies.
56. ** Fumonisin: In conjunction with National Center for Toxicological Research, the Department of Agriculture, the National Institute of Environmental Health Sciences, and the International Life Sciences Institute North America, CFSAN convened an international conference on fumonisin. The goal of the conference, which was held on June 28 – 30, 1999, was to review the available data on the chemistry, toxicities, and mechanisms of action of the fumonisin mycotoxins.

Cosmetics

57. Alpha Hydroxy Acids: An FDA sponsored clinical study of the affects of AHAs on the sensitivity of human skin to ultraviolet light was completed. This study, along with others, will help support agency decisions concerning possible public health risks. FDA also worked collaboratively with the NCTR and NTP in the development of a state-of-the-art phototoxicity testing facility and the development of photocarcinogenicity testing protocol for measuring the long-term effects of AHAs as used in topically applied cosmetic products.

58. ** Diethanolamine (DEA): CFSAN's Cancer Assessment Committee completed an evaluation of the NTP dermal carcinogenicity study of DEA and three DEA-derived cosmetic ingredients. The risk posed by dermal exposure to DEA was then assessed by CFSAN's Quantitative Risk Assessment Committee and a draft risk assessment memorandum completed. In 2000, CFSAN will finalize the DEA risk assessment and formulate appropriate risk management approaches.

59. Cosmetics Voluntary Registration Program: The Cosmetic Voluntary Registration Program was reinstated effective January 1, 1999. In addition, CFSAN initiated steps to build a web-based program in response to suggestions by the cosmetics industry that participation requirements should be streamlined.

60. Program Restoration: FDA developed and implemented a plan to restore $2.5 million to the cosmetics program, as provided in the FY 99 Appropriations. A public meeting to solicit input from Stakeholders on development of the plan was held on January 22, 1999. Plan elements included reallocating staff back to cosmetics activities, recruitment of new personnel and allocation of funds to critical program needs.

Science Base

61. Joint Institute for Food Safety and Applied Nutrition (JIFSAN): On July 26, 1999, CFSAN published a Federal Register notice indicating FDA's intent to supplement the original cooperative agreement award. The intent of the notice was two fold; 1) to incorporate the cosmetics program and to include dietary supplements and food labeling under the broad program area of applied nutrition; and 2) to permit supplementation of the cooperative agreement beyond the Agency limitation of 25 percent. Supplemental funding was awarded on 9/30/99. On September 27, 1999, CFSAN completed its descriptions of the JIFSAN program management structure and coordination activities within FDA.
62. National Center for Food Safety and Technology (Moffett Center): A cooperative agreement with the National Center for Food Safety and Technology has been renewed for five additional years. In addition, their capabilities were expanded to rapidly develop, evaluate, and transfer technologies that control emerging food safety problems, such as sprouts and unpasteurized juices.

63. ** Consolidated Management System for Research: An internal task group was formed to develop a research program management system that ensures that priority, mission-relevant public health needs are addressed in a cost- effective, timely, accountable, and transparent fashion. Following finalization of the group's report in 2000, the Research Management Task Group will develop a plan for implementing its recommendations.

64. Peer Review: The subcommittee of the FDA Science Board reviewed the Center's non-FSI research program. The subcommittee's peer review report is expected to be presented to the FDA Science Board at its first meeting in 2000.

65. Regulatory Scientists: A report titled "Preliminary Training Plan" has been prepared to identify and address training needs of regulatory scientists to strengthen and thereby, enhance the Center's total science base. This preliminary plan is intended to apply to the needs of all Center scientists, including those involved with regulatory programs, laboratory or other research, administration and management. In addition to training activities planned by components within CFSAN, the report includes activities that are developed by and conducted through the Center's consortia, the Joint Institute for Food Safety and Applied technology and the National Center for Food Safety and Technology.

66. ** Biotechnology Public Meetings: Three meetings were held to give the public an opportunity to provide comments on CFSAN's policy for assuring the safety of food produced through biotechnology. The first meeting was on November 19, 1999 in Chicago, Illinois; the second meeting was on November 30 in Washington, D.C.; and the third was on December 13 in Oakland, California. In 2000, CFSAN will develop and implement strategies based on these public meetings.

Federal - State - Local

67. National Food Safety System: In collaboration with CDC, USDA, and state and local governments, continued progress was made towards development of a plan for a nationally integrated food safety system. All three 1999 milestones were completed: Creation of a Coordinating body to focus on a vision and next steps; establishment of work groups to draft proposed plans and projects; and solicitation of input from stakeholders. A public workshop was held in conjunction with a meeting of the Association of Food and Drug Officials on June 6 in San Antonio, Texas. Long-term planning ideas will be integrated into the strategic planning process being conducted by the President's Council on Food Safety.

International

68. ** Develop Affirmative Agenda: In the Federal Register of December 20, 1999 (64 FR 71145), CFSAN published a notice of availability of its Affirmative Agenda for International Activities for 2000 – 2002. The Agenda addresses broad priorities in five major international activities: Regulatory; Harmonization; Development, Maintenance and Dissemination of CFSAN's Science Base; Equivalence Evaluations, Food Safety Needs Assessments, and Food Safety Technical Cooperation and Assistance; and Trade-Related Activities.

Human Resources

69. Communications: Goals to increase communication among all levels of employees within CFSAN have been accomplished. A variety of mechanisms were implemented to increase communication, including all-hands e-mail messages from the Center Director; the Center Director's monthly meetings with CFSAN staff; continuation of "Break Time" seminars; re-instatement of a bi-monthly newsletter; and issuance of the CFSAN Employee Survey.

70. Training: CFSAN accomplished its goal to increase its internal capacity to train employees. CFSAN pilot-tested an electronic training nomination form to facilitate quicker, more efficient processing of forms and enrollment into classes. The Intranet site was expanded to provide information to employees about training opportunities and resources, and to respond to frequently asked questions about these opportunities and resources. Thirdly, catalogues, workshops, software and other materials were publicized electronically.
71. Quality Environment: Several initiatives were accomplished to improve the quality of worklife for all employees. CFSAN implemented the Healthy Lifestyles Program; provided quarterly fitness classes; established an Employee Worklife Network to compile, triage and address issues raised by employees; provided health seminars and nutrition workshops; implemented a "New Day" initiative and companion "Tool Kit" on workplace policies and procedures; established partnerships with union representatives; and assured that the goals of the equal employment opportunity program were promoted and adhered to.
72. Future Skill Needs: CFSAN developed a recruitment policy guide for identifying future skill needs by inventorying the skills currently available in the Center and identifying where gaps exist in scientific expertise and other human resource needs.

73. ** Enterprise Administrative System Environment (EASE) Implementation: EASE is an electronic data system that replaces the manual process of time and attendance recordkeeping with automated verification, submission, and approval of timecards. In 1999, EASE software was installed and training for timekeepers, administrative staff and supervisors was initiated.

Ten goals in the Program Priorities document were not fully completed in 1999; however, considerable progress was made on each. For example, with respect to publication of a final rule on juice HACCP, CFSAN presented data to the National Advisory Committee for Microbiological Criteria in Food on production practices and safety issues associated with fresh citrus juice. With regards to development of an action level for patulin, CFSAN presented an assessment of the risk and a proposed action level to the Foods Advisory Committee. Accordingly, the following ten initiatives will be carried over to 2000 and new goals be established:

CFSAN addressed a number of unanticipated issues during 1999 that were not included in the Program Priorities document. For example, during the summer it was reported that food-producing animals in Belgium may have consumed feed that was contaminated with dioxin, a potential carcinogen. In response, in collaboration with ORA, CFSAN implemented an import detention program and sampling plan for potentially contaminated food products, such as eggs. Consumer warnings and advisories about potentially contaminated food are another example of unanticipated issues not included in the Program Priorities that necessitated a commitment of CFSAN resources during 1999.

In addition to the above-mentioned unanticipated issues, CSFAN fully completed a number of its "B" list goals. These are listed below with an asterisk.

Consumer Alerts

• Alerted consumers not to purchase or consume products, some of which are labeled as dietary supplements, that contain gamma butyrolactone (abbreviated as GBL).

• Warned consumers not to eat El Sembrador brand frozen mamey from Guatemala or drinks made from El Sembrador brand frozen mamey due to reports of typhoid fever in South Florida.

• Advised all persons to be aware of the risks associated with eating raw sprouts (e.g., alfalfa, clover, radish).

• Warned parents in Southern California who feed their babies Mead Johnson's Nutramigen Powder infant formula to be aware of a potential counterfeit labeling fraud.

Consumer Information

• Established an Outreach and Information Center to facilitate access by consumers to the most up-to-date, reliable food safety information. The information hotline can be reached by calling 1-888-SAFEFOO[D].

• * In conjunction with USDA, developed and implemented an Information Network to enhance availability of food safety-related information and publications. The Information Network can be accessed at www.FoodSafety.gov.

• Increased the information consumers will see on labels of dietary supplement products, including an information panel titled "Supplement Facts," a clear identity statement, and a complete list of ingredients.

Seafood

• * Updated guidance on frequently asked seafood HACCP questions.

• * Developed a HACCP "template" code of practice for fish products through the Codex international workgroup.

• Worked with the ISSC to develop a control plan for Vibrio parahaemolyticus in shellfish.

Research and Risk Assessment

• * Finalized the charter for the Risk Assessment Consortium.

• * Held a public meeting to develop a framework for the Risk Assessment Clearinghouse.

• Expanded PulseNet capability to six FDA district laboratories.

• Developed an improved polymerase chain reaction (PCR) method for the detection of Cyclospora.

• Demonstrated that surface heating of apples is an effective method to inactivate 2-3 logs of microorganisms, including E. coli O157:H7, in apple processing facilities.

Imports and Domestic Samples Analysis

• Worked with the Guatemalan berry industry to help improve the safety of berries and other fresh produce exported from Guatemala to the U.S.

• Implemented an import detention and domestic sampling plan for certain European products in response to concerns about potential dioxin contamination.

FDA Modernization Act (FDAMA)

• Held a public meeting on the FDAMA provisions on health claims based on authoritative statements.

• Issued guidance document entitled "Mercury Compounds in Drugs and Food," as required by section 413 of FDAMA.

Chemicals and Other Contaminants

• * Issued a Compliance Policy Guide on Adulteration Involving Sharp Foreign Objects in Food.

Hypertext updated by cjm/ear/dms 2005-OCT-19