U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
January 28, 2002

Dear Colleague, FDA Foods Community:

As promised, I am pleased to provide you with the end-of-the-year "Report Card" on our 2001 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 over 85% of our "A" list goals (108 out of 127 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.

There are three points I would like to highlight about our FY 2001 accomplishments. First, our primary theme for the 2001 workplan was program continuity. You will see continued emphasis on food safety, food additives, dietary supplements, and food biotechnology. Second, I draw your attention to our many important accomplishments in three emerging areas that were identified in our "mid-year" report: BSE prevention, StarLink corn, and food allergens. Third, as you will see in the cross-cutting program section, a major accomplishment in 2001 was to prepare for, and actually begin moving CFSAN personnel and laboratories in Washington, D.C. into a new facility in College Park, Maryland. If you did not receive notification about this move, our new address is 5100 Paint Branch Parkway, College Park, MD 20740. That move is going very smoothly and will be completed in March, 2002.

I would also like to address an issue that is not identified in the "Report Card" for 2001 -- i.e., assuring the security of our food supply. The tragic events on September 11^th have, regrettably, raised our collective awareness as to the importance of this issue. I want to assure our stakeholders that, since September 11^th, we have been actively engaged on a continuous basis to increase our vigilance and preparedness. I want to thank many of you for the ideas and assistance you have provided to us during this critical time. I encourage you to review our FY 2002 workplan, also distributed today, which highlights our activities in this important area.

Finally, I would like to reiterate my continued appreciation for the support I have received from many stakeholders on this management approach. I look forward to continuing this tradition of building predictability, transparency, and accountability into our Foods program. The American public deserves no less.

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

• College Park
  
• Science Base
  
• International
  
• Biotechnology
  
• Food Allergens
  
• Adverse Event Reporting
  
• Transmissible Spongioform Encephalopathy (TSE)/Bovine Spongioform Encephalopathy (BSE)
  
• Regulatory Processes
  
• Management Initiatives

Domestic Inspections

1. Inspected nearly 80% of domestic firms producing foods at "high risk" of microbiological contamination (i.e., approximately 5300 of the approximately 6800 "high risk" establishments). (Note that domestic travel was curtailed from September 11^th until October 1^st.) Overall, FDA and the states (under FDA auspices) conducted approximately 14,000 domestic food inspections.

2. Refined the definition of "high risk" foods to include -- beginning in FY 2002 -- in addition to microbiological pathogens: biological toxins; allergenic substances; bovine spongiform encephalopathy (BSE) infective materials; as well as the omission or under/over fortification of nutritive ingredients in infant formula and medical foods.

3. Continued to implement three-year strategy to enhance FDA audit and evaluation of State inspection programs. Specific accomplishments include meetings with state program managers to introduce them to the audit process; development of audit procedures, audit forms and guidance documents; development of a 3-day training course; and completion of the first audit course (August 14-16, 2001). Thirty-two auditors were trained at the course, at least one from every FDA District Office and 5 state personnel. Two more audit courses are scheduled for FY 2002: January 29 - 31 and Mach 12 - 14. A total of 65 more auditors will be trained at these courses.

4. Conducted 209 inspections of foreign food establishments, with top priority to "high risk" foods. (Note that foreign travel was cancelled from September 11^th until October 1^st.) This is an increase from 165 such inspections conducted in FY 2000 and 65 in FY 1999.

5. Published guidance for field personnel to ensure that imported food is held in secure facilities until FDA has reviewed and released the shipments into domestic commerce. Additional information on this issue is available on our web site at www.cfsan.fda.gov/~lrd/tpimport.html.

6. Published a proposed rule on the marking of refused food shipments (66 FR 6502; January 22, 2001).

7. Published guidance for field personnel on the imposition of civil money penalties, under Customs' authority, related to the importation of unsafe food. Additional information on this issue is available on our web site at www.cfsan.fda.gov/~lrd/tpimport.html.

8. Continued to advance international food safety efforts by conducting two training workshops, "Food Safety Initiatives Influencing Public Health and Trade," in Midrand, South Africa, on March 27 - 29, 2001; and in Singapore on August 29 - 30, 2001.

9. Conducted the fourth year of seafood HACCP inspections. FDA sent 212 Warning Letters. In keeping with the Agency's focus on products that could present a "high risk" to consumers, half of these were directed toward inadequate controls for pathogens, a third were directed toward inadequate preventive controls for scombrotoxin, and nearly 20 percent involved the absence of a HACCP plan or lack of importer verification procedures. As a result of overseas inspections, 14 foreign processors were placed on detention without physical examination due to inadequate HACCP controls, while 7 foreign processors made corrections necessary to be released from detention without physical examination.

10. Completed an evaluation of FDA's Seafood HACCP program for calendar years 1998 and 1999. A copy of this evaluation is available on our web site at www.cfsan.fda.gov/~comm/seaeval.html.

11. Issued a "Mid-Course" correction to the Seafood HACCP program to focus on processors whose products present the highest risk to consumers. These include firms that need to control for pathogens; firms that need to control for histamines (these can cause allergic reactions); and firms that do not have HACCP plans. A copy of this document is available on our web site at www.cfsan.fda.gov/~comm/shaccp1.html.

12. Worked with the Interstate Shellfish Sanitation Conference (ISSC) to develop an effective control strategy for Vibrio vulnificus. The control plan was adopted by ISSC at their annual meeting on July 27, 2001. It included increased use of post-harvest treatments within 3 years, and is intended to reduce Vibrio vulnificus illness by 40% in 5 years and 60% in 7 years.

13. Published a draft risk assessment on the relationship between Vibrio parahaemolyticus in raw molluscan shellfish, specifically oysters, and human health (66 FR 5517, January 19, 2001).

14. Issued advice to consumers on methyl mercury in fish, and initiated a public education program. Additional information on this issue is available on our web site at www.cfsan.fda.gov/~lrd/tphgfish.html.

15. Submitted a Report to Congress on FDA's updated Consumer Advisory regarding mercury exposure from seafood consumption.

16. Published the final rule on HACCP for fruit and vegetable juices to improve their safety (66 FR 6137; January 19, 2001).

17. In conjunction with ORA, continued to analyze samples of domestic produce for the presence of microbial pathogens, with the goal to complete 1,000 samples. To date, 907 samples have been collected. Interim results based on an analysis of the first 767 samples are available on our web site at www.cfsan.fda.gov/~dms/prodsur9.html. Of the 767 samples analyzed, six samples were found to be contaminated with Salmonella and six samples were found to be contaminated with Shigella.

18. Completed an evaluation of information from the sampling assignment to analyze 1000 imported produce samples for the presence of microbial pathogens. A copy of this evaluation is available at www.cfsan.fda.gov/~dms/prodsur6.html.

19. In collaboration with the Joint Institute of Food Safety and Applied Nutrition (JIFSAN), conducted two Regional Good Agriculture Practices Training Programs as "Train-the-Trainer" courses. The training programs were held May 28 through June 2, 2001 in Central America, and June 4 - 8 in Brazil.

20. Published the final rule on egg labeling and refrigeration (65 FR 76091; December 5, 2000).

21. Provided materials through FDA's Division of Federal-State Relations and field offices on implementation of the egg labeling and refrigeration rule. Materials included a "Constituent Alert" that contains suggested text a State can use to inform governmental subdivisions of the rule's existence and requirements; a powerpoint presentation for use at regional meetings and for web-based training; and guidance for small businesses.

22. Conducted an education campaign for the egg labeling and refrigeration rule, including print materials for consumers -- "Playing it Safe with Eggs: What Consumers Need to Know" -- which is available at www.cfsan.fda.gov/~dms/fs-eggs.html; "Assuring the Safety of Eggs and Egg Dishes Made from Raw Shell Eggs," which is available at www.cfsan.fda.gov/~dms/fs-eggs2.html; and guidance for small businesses on implementing the regulation which is available at www.cfsan.fda.gov/~dms/eggsguid.html.

23. Initiated a Salmonella Enteritidis (SE) research plan. Thus far under the plan, FDA has evaluated laboratory and environmental methods for detection of SE, and initiated research into microwave pasteurization, rapid methods of SE detection, and measurement of thermo and dielectric properties of eggs.

Listeria

24. Published, for public comment, a draft risk assessment on Listeria monocytogenes contamination in food (66 FR 5515; January 19, 2001). (Jointly with USDA)

25. Published, for public comment, a draft action plan to reduce Listeria monocytogenes contamination in food (66 FR 5515; January 19, 2001). (Jointly with USDA)

26. On March 19, 2001, convened a public meeting to solicit comments on the draft risk assessment and draft action plan.

27. Issued a "Consumer Advisory" on how to safely handle refrigerated ready-to-eat foods to avoid listeriosis. The guidance includes advice to at-risk consumers (pregnant women, older adults and persons with weakened immune systems) of foods that have a greater likelihood of containing Listeria monocytogenes. A copy of the Advisory is available at www.cfsan.fda.gov/~dms/adlister.html. In conjunction with USDA, issued additional guidance for consumers on listeriosis and pregnancy. A copy is available at www.fsis.usda.gov/OA/pubs/lm_tearsheet.htm.

28. Implemented a research program to provide Listeria monocytogenes (Lm) control interventions, data and understanding. Highlights of this research program include: (1) Initiated the JIFSAN / NFPA Listeria retail project to evaluate the prevalence of Lm in certain ready-to-eat (RTE) foods. Data generated from study will be used in the next version of the HHS/USDA Listeria risk assessment. (2) Initiated a collaborative project between the New York State Dept. of Agriculture and Markets and FDA's New York Regional Lab to enumerate Lm positive food samples collected through the state's retail surveillance program. (3) Funded extramural grants to investigate consumer handling of RTE foods after purchase, and the home refrigeration knowledge of and practices of consumers. (4) Funded a grant to support the investigation of a primate risk assessment dose response model for foodborne Lm. (5) Held planning meetings with the Department of Defense to initiate a collaborative study to analyze RTE foods from military commissaries for the presence and levels of Lm to support development of databases for improving future risk assessments. (6) Initiated discussions with the University of Maryland Medical School concerning development of a joint research project to determine the frequency of asymptomatic human carriage of Lm. (7) Initiated efforts to prioritize CFSAN intramural research needs on Lm.

29. Established a mechanism to expand efforts to gather exposure assessment data on Listeria. The data will come from the JIFSAN-NFPA Listeria Retail Food Study. The study will be 18 months in duration.

Education

30. Distributed a senior citizen food safety video and 25 publications as a package to 800 offices of the Administration on Aging; 10,000 senior day care centers; FDA field public affairs specialists; and all county and state Extension service offices.

31. In collaboration with the National Science Teachers Association, distributed the secondary schools food safety curriculum for incorporation into the 2001 - 2002 school year. At a Press Conference held to highlight the program, science teachers and students demonstrated hands-on activities from the program, showcasing how pasteurization and refrigeration can make foods safe to eat and how easily bacteria can spread. Additional information about the program is available on our web site at www.cfsan.fda.gov/~dms/fscupd42.html.

Premarket Review of Food and Color Additives and Food Ingredients

32. For the petition receipt cohort of FY 2000, completed the safety evaluation in less than 360 days for nine of ten food additive petitions subject to expedited review. This meets the goal to review 80-90% of these submissions within 360 days. 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. A list of pending and completed petitions eligible for expedited review is available at www.cfsan.fda.gov/~dms/opa-expd.html.

33. For the petition receipt cohort of FY 2000, completed the safety evaluation in less than 360 days for 91% (20 of 22) of food and color additive petitions that do not qualify for expedited review. This exceeds our goal was to complete 50 - 60% of these petitions within 360 days.

34. Completed actions on 22 of 37 (59.5%) petitions that were more than 1 year overdue at the start of the fiscal year. This exceeds our goal to reduce by 50% the number of pending food and color additive petitions more than 1 year overdue on 10/1/01.

35. Completed review of 2 of the 3 biotechnology notifications in the FY 2000 cohort within 180 days. This meets the goal to review 66% of such notifications within 180 days.

36. Completed final action on 20 GRAS notifications received in FY 2000. Sixteen (59%) were completed in less than 180 days, and four (15%) in greater than 180 days. Additional information on completed and pending GRAS notifications is available on our web site at www.cfsan.fda.gov/~rdb/opa-gras.html.

37. Completed review of all 109 food contact substances received in FY 2000 within 120 days.

38. Completed the reorganization of the Office of Premarket Approval into the new Office of Food Additive Safety. A letter announcing this reorganization is available on our web site at www.cfsan.fda.gov/~dms/opareorg.html.

39. Created four review templates to facilitate the internal review of toxicology data in food and color additive petitions: 90-day rodent studies; 90-day dog studies; the Ames Salmonella assay (genotoxicity); and the mouse lymphoma assay.

40. Submitted a Report to Congress on use of FY 2000 additional funds earmarked to accelerate the rate of review of direct food and color additive petitions.

Nutrition, Health Claims and Labeling

41. Conducted focus group research to understand how consumers react to alternative formats of irradiation labeling. Two groups were conducted in Maryland on June 18; two groups in California on July 9; and two groups in Minnesota on July 11. Each group consisted of 7 to 10 people recruited at random by telephone from large lists of the general population in the local area. A final report on the irradiation labeling focus groups will be finalized and made available on our web site.

42. Completed the review of 28 notifications for new infant formulas, all within the 90-day statutory timeframe.

43. Continued to meet statutory obligations for nutrient content and health claim submissions. A health claim based on an authoritative statement concerning the relationship of potassium-containing foods to blood pressure and stroke became effective on October 31, 2000 (see www.cfsan.fda.gov/~dms/hclm-k.html). A nutrient content claim based on an authoritative statement concerning foods containing choline became effective on August 29, 2001 (see www.cfsan.fda.gov/~dms/flcholin.html). FDA re-opened the comment period for the interim final rule authorizing the health claim on the association between plant sterol/stanol esters and reduced risk of coronary heart disease (66 FR 50824; October 5, 2001).

44. Issued a letter to manufacturers regarding conventional foods that contain novel ingredients, such as botanicals, that often bear claims to provide certain health benefits. A copy of this letter is available on our web site at http://www.cfsan.fda.gov/~dms/ds-ltr15.html.

45. Issued warning letters to define boundaries among product categories and prevent misleading claims and ensure ingredients in products are safe. Warning letters were issued to ten manufacturers of "protein bars" and to four manufacturers of conventional foods that contain botanical ingredients. Copies of these letters are available at www.fda.gov/foi/warning.htm.

46. Completed data collection and creation of a database for the Year 2000 Food Label and Package Survey (FLAPS).

47. Submitted a Report to Congress on the adoption of a qualified health claim relating consumption of omega-3 fatty acids to reduced risk of coronary artery disease.

48. Submitted a Report to Congress on the status of the proposed regulation on food irradiation labeling.

Dietary Supplements

49. Issued a final determination on a proposed health claim for vitamin B and reduced risk of vascular disease in dietary supplement labeling. FDA is using its enforcement discretion to allow appropriately qualified claims about B vitamins, serum homocysteine, and a reduced risk of vascular disease. A copy of this letter is available on our web site at www.cfsan.fda.gov/~dms/ds-ltr12.html.

50. Issued a final determination on a proposed health claim for antioxidant vitamins and reduced risk of certain kinds of cancer in dietary supplement labeling. FDA determined that there is no significant scientific agreement for the relationship between consumption of antioxidant vitamins and reduced risk of certain kinds of cancer, and that the scientific evidence for a relationship is outweighed by the scientific evidence against the relationship. Therefore, FDA determined that such a proposed claim can not be made non-misleading with a disclaimer or other qualifying language. A copy of this letter is available on our web site at www.cfsan.fda.gov/~dms/ds-ltr23.html.

51. Issued a final determination on a proposed health claim for vitamin E and reduced risk of heart disease in dietary supplement labeling. FDA determined that there is no significant scientific agreement for the relationship between consumption of supplemental vitamin E and reduced risk of heart disease, and that the scientific evidence for a relationship is outweighed by the scientific evidence against the relationship. Therefore, FDA determined that such a proposed claim can not be made non-misleading with a disclaimer or other qualifying language. A copy of this letter is available on our web site at www.cfsan.fda.gov/~dms/ds-ltr16.html.

52. Reviewed 22 notifications for new dietary ingredients. All were reviewed within the 75-day statutory timeframe. Of these 22 notifications, 6 were filed without comment; 4 were filed with comment; and 12 were filed with objection (5 were not dietary supplements, and the remaining 7 did not meet minimum requirements of 21 CFR 190.6 and/or did not provide an adequate basis that the new dietary ingredient was reasonably expected to be safe).

53. Issued a letter to the dietary supplement industry reiterating public health and safety concerns regarding the manufacturing or importing of dietary supplements that contain specific bovine tissues. The safety concerns about bovine-derived dietary supplement ingredients are a result of the fact that such ingredients from cattle born, raised, or slaughtered in certain countries present a risk of transmitting the infectious agent that causes bovine spongiform encephalopathy (BSE) to humans consuming such products.

54. Issued a warning to consumers regarding products marketed as dietary supplements that contain tiratricol, also known as triiodothyroacetic acid or TRIAC, a potent thyroid hormone that may cause serious health consequences including heart attacks and strokes Additional information on this action is available on our web site at www.cfsan.fda.gov/~lrd/tptriac.html.

55. Issued a Consumer Advisory and letters to industry and health professionals to communicate concerns about the use and marketing of dietary supplements or other botanical-containing products that may contain aristolochic acid. Additional information on this issue is available on our web site at www.cfsan.fda.gov/~dms/ds-bot.html.

56. Issued a letter to industry and health professional organizations to communicate concerns about the marketing of dietary supplements that contain the herbal ingredient comfrey (Symphytum officionale (common comfrey), S. asperum (prickley comfrey), and S. x uplandicum (Russian comfrey). These plants are a source of pyrrolizidine alkaloids that present a serious health hazard to consumers when they are ingested. A copy of this letter is available on our web site at www.cfsan.fda.gov/~dms/dspltr06.html.

57. Entered into a contract with the National Academy of Sciences' Institute of Medicine to develop a framework for FDA to use in prioritizing and evaluating dietary supplement safety. The contract covers the time period September 30, 2000 - September 29, 2002. The contract requires that the IOM constitute a committee that will (1) develop a proposed framework for categorizing and prioritizing dietary supplement ingredients based on safety issues, (2) describe a process for developing a review system with specifications for evaluating the safety and role in health of dietary supplement ingredients, and (3) develop at least six prototypes as examples of using the proposed framework. Additional information on this contract is available on our web site at www.cfsan.fda.gov/~dms/ds-ltr13.html.

58. Reviewed available literature on isoflavones, developed a method for measuring the most common isoflavones found in foods, and utilized the method to measure isoflavones in products such as soy flour and dietary supplements. Analysis of products labeled as containing isoflavones will continue in FY 2002.

59. Submitted a Report to Congress on implementation of the decision in the United States Court of Appeals for the District of Columbia Circuit Court in Pearson v. Shalala regarding dietary supplement health claims.

Chemical Contaminants, Pesticides and Other Hazards

60. Issued a compliance policy guide (CPG) on adulteration of apple juice and apple juice products with patulin, a toxic substance that may grow on applies. A copy of the CPG is available on our web site at www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg510-150.htm. (66 FR 55000; October 31, 2001)

61. Following publication of the patulin CPG, issued an assignment to the field to determine consistency of patulin levels with the guidance. This work will be done in FY 2002.

62. Issued a final guidance document for industry on fumonisin levels in foods and animal feeds. Fumonisins are mycotoxins produced mainly by a mold that is commonly found on corn. A copy of the final guidance is available on our web site at www.cfsan.fda.gov/~dms/fumongu2.html. (66 FR 56688; November 9, 2001)

63. Following publication of the fumonisin guidance, issued an assignment to the field to determine the consistency of fumonisin levels with the guidance. This work will be done in FY 2002.

64. Developed a strategy to expand dioxin surveillance and issued a field assignment to collect and analyze 500 food samples for dioxin. Testing is to be done at ORA's Arkansas Research Laboratory (ARL).

65. Published the final "channels of trade" guidance for industry on foods containing methyl parathion residues (66 FR 1246; January 5, 2001).

66. Actively participated in interagency meetings and meetings with industry representatives to ensure a timely and thorough review of issues resulting from the inadvertent contamination of food products with StarLink corn.

67. Published guidance to the industry on testing for Starlink corn (66 FR 6627; January 22, 2001).

68. Collected 236 samples of foods made from corn products or corn meal and tested them for the presence of StarLink corn. Six products were found to contain StarLink corn. All products remaining on the market with positive findings were recalled.

69. Developed a laboratory method to detect antibodies to the Cry9C protein. This was necessary for subsequent allergen testing as the existing tests could only detect antibodies to Cry9C DNA.

70. Provided information to CDC on a study to determine if any consumers who reported adverse events following consumption of foods made with corn have mounted an antibody response to the Cry9C protein. The results of this investigation, which showed no immune reactions in the consumers, are contained in a report titled, "Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified Corn" which is posted at www.cdc.gov/nceh/ehhe/Cry9cReport/cry9creport.pdf (400 Kb).

71. Conducted an inter-laboratory validation study of an ELISA method for the detection of the Cry9C protein in processed foods, and shared the results with EPA.

72. Published a Direct Final Rule to adopt EPA's regulation for disinfection byproducts in public drinking water as a quality standard (66 FR 16858; March 28, 2001). [Note: Moved up from the "B" list.]

73. Published a notice confirming the January 1, 2002 effective date for adoption of EPA's regulation for disinfection byproducts in public drinking water as a quality standard. (66 FR 35439; July 5, 2001)

Cosmetics

74. Analyzed all batches of color additives and determined certification status (i.e., certify or refuse to certify) within an average of 5 working days.

College Park

75. Conducted an intensive information-sharing program to keep CFSAN personnel informed on the status of the move to College Park, the programs in place to plan the move, and details for the actual move. Information was disseminated via "All Hands" messages to staff; "All Hands" and "Town Hall" meetings with staff; maintenance of a College Park Bulletin Board; and the Center's Intranet site.

76. Completed, in partnership with the NTEU, space assignments and furniture selection for the new building in College Park, MD that will house CFSAN headquarters offices and laboratories.

77. Successfully pursued and received requested funding from FDA to furnish, move into, and occupy the College Park building. Received funding from FDA to renovate and occupy MOD1 and the Beltsville Research Facility. Initiated a process with the General Services Administration to identify and obtain additional space for CFSAN staff that could not be accommodated in the new College Park building.

78. In conjunction with relocation planning and management consultants, effectively utilized multiple task groups to plan all projects necessary to move CFSAN personnel into the new facility. These task group efforts included installation of cabling, phones and network services; development of an integrated library system; implementation of a standard records management scheme for files; oversight of a phased cleanup plan for all files, offices, laboratories and storage rooms; purchase and installation of new office workstations and furnishings for public spaces and conference rooms; procurement of new service and support contracts; and development of plans to decommission FB-8.

Science Base

79. Established CFSAN Staff College and initiated key "core training" activities. In its first year, the Staff College presented or co-sponsored 56 different courses on FDA/CFSAN-pertinent topics in science, law and regulations, administration and management, communications, and professional development. Science training (258 classroom hours, 430 students) ranged from laboratory courses in analytical methods through workshops on statistical procedures and data analysis to seminars on risk analysis and issues on the research forefront. Food and Drug Law was taught 3 times and training was given in regulations development (144 hours/152 students). Topics in administration and management (2130 hours/558 students) included project officer training, customer service skills, and timekeeping. Communications training (152 hours/125 students) ranged from computer courses through coaching in public speaking. For the professional development of CFSAN staff (10,394 hours/80 students), a mentoring program was piloted and an in-house succession series was launched.
    

80. Reviewed nominations and prepared membership documentation for a new Food Advisory Committee structure - a "parent" committee in addition to four subcommittees: dietary supplements; food additives and ingredients; contaminants and natural toxicants; and food biotechnology. (For additional information see 65 FR 46463: July 28, 2000.)

81. Implemented a collaborative research program for botanical dietary supplements with the University of Mississippi National Center for Natural Products Research. Funds for this program were authorized by Congress in FDA's FY 2001 appropriation (66 FR 22236; May 3, 2001).

82. Following review of the animal care and use program and inspection of animal facilities, the program received "full accreditation" by the Association of Assessment and Accreditation of Laboratory Animal Care (AAALAC).

83. Developed a 3-year plan for research conducted at or by personnel from the newly created Office of Applied Research and Safety Assessment (OARSA). The research projects demonstrate OARSA's capabilities in a variety of scientific disciplines, including whole animal toxicology, reproductive and developmental toxicology, immuno-toxicology, in vitro toxicology, and pharmacokinetic and genetic toxicology. The OARSA research plan is a fluid document and as important new issues arise, additional research proposals will be implemented.

International

84. Participated in meetings of 17 Codex committees and related technical committees that are developing internationally recognized standards in areas that include food hygiene, food additives and contaminants, food labeling, foods derived from modern biotechnology, food import/export inspection and certifications systems, and composition standards for processed foods. Provided the U.S. Delegate and/or Alternate U.S. Delegate to 14 of these Committees.

85. In February 2001, participated in WHO's Strategic Planning on Food Safety meeting and presented one of six papers. In March and May, 2001, CFSAN represented the U.S. at meetings of the G8 countries and a larger group of 22 countries to prepare for the Global Forum for Food Safety Regulators meeting that was originally scheduled for October 2001, and was re-scheduled in January 2002. This forum will allow countries around the world to discuss food safety problems and solutions.

86. Participated in Technical Working Groups (TWGs) with Canada and Mexico where much progress has been made on several important food safety activities. FDA and the Canadian Food Inspection Agency (CFIA), for example, as part of an Action Plan on Food Safety, finalized a document aimed at ensuring the microbiological safety of selected fruits and vegetables traded between the two countries. A corresponding activity pertaining to pesticide residue compliance is now being developed. Similarly, FDA and Mexico's Ministries of Health and Agriculture have entered into a cooperative agreement that should significantly enhance each government's ability to prevent or trace outbreaks of foodborne illness. A notice of this Cooperative Agreement, which became effective on September 4, 2001, was published in the Federal Register on December 26, 2001 (66 FR 66418).

Biotechnology

87. Published biotechnology mandatory premarket notification proposal (66 FR 4706; January 18, 2001).

88. Published draft guidance for voluntary labeling of foods that have or have not been developed using biotechnology (66 FR 4839; January 18, 2001).

Food Allergens

89. Held a public meeting on August 13, 2001, in Washington, DC, to discuss the labeling of foods containing allergens and the inadvertent addition of allergens to foods due to processing practices. The purpose of the meeting was to stimulate discussion and to obtain information to assist FDA in determining what additional actions may be necessary to provide consumers with adequate information on product labels. FDA will use information gleaned from this meeting to develop a strategy for clearer labeling of food allergens.

90. On April 9, 2001, issued a field allergen inspection guide to assist field investigators in assessing conditions that can cause foods to contact allergens. A copy of this document is available at www.cfsan.fda.gov/~dms/wh-alrgy.html.
    

91. Published a draft Compliance Policy Guide (CPG) entitled "Statement of Policy for Labeling and Preventing Cross-Contact of Common Food Allergens" (66 FR 22240; May 3, 2001). A copy f the CPG is available at www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-250.htm.

92. Provided training for investigators in three districts on how to address food allergens during inspections. The training was videotaped and will be provided to investigators in other District Offices and state regulatory offices.

93. Issued a field assignment to the three District Offices that received training to conduct 8-10 inspections of food firms that produce foods susceptible to contamination with allergenic ingredients. The inspections were targeted for completion within 60 days.

94. To further increase allergen awareness, the eight most common food allergens were incorporated into broader food safety programs, including the 2001 Food Code, the draft Juice Hazards and Controls Guide, the Seafood Hazards and Controls Guide (3^rd edition), and the Pasteurized Milk Ordinance.

95. Established a web site for all allergen-related documents. The site address is www.cfsan.fda.gov/~dms/wh-alrgy.html.

Adverse Event Reporting

96. Completed development of a model for a centralized adverse event reporting system called CAERS -- CFSAN Adverse Event Reporting System. CAERS will replace the patchwork of existing AER systems that are now maintained by individual offices. The model reporting system is currently being pilot-tested. Results of this testing will be used to make further enhancements to the system before it is fully operational.

Transmissible Spongioform Encephalopathy (TSE)/Bovine Spongioform Encephalopathy (BSE)

97. In collaboration with USDA/APHIS, reinforced the existing import ban, with more specific product information on CFSAN-regulated products, including food products, dietary supplements and cosmetics that contain bovine materials from BSE-identified countries, so that banned products do not enter the United States.

Regulatory Processes

98. Counter-Terrorism: In conjunction with ORA, finalized an internal bioterrorism plan to address intentional chemical and biological contamination of foods and water associated with food production. As this effort was on-going prior to the events of September 11, 2001, more expansive counter-terrorism efforts are now underway. Additional information on FDA's counter-terrorism activities is available at www.fda.gov/oc/opacom/hottopics/bioterrorism.html.

99. Field Workplan: Updated compliance programs to provide additional specificity to FDA's FY 2002 Field Workplan with respect to inspections and sampling of food, dietary supplements, and cosmetic products. Copies of all 22 food and cosmetic compliance programs are now available on our web site at www.cfsan.fda.gov/~comm/cp-toc.html.

Management Initiatives

100. National Treasury Employees Union (NTEU): Worked closely in partnership with personnel from Chapter 282 of NTEU to fully implement the NTEU Collective Bargaining Unit Agreement. Established a CFSAN-NTEU Partnership Committee comprised of four CFSAN management representatives and four NTEU representatives to address workplace issues. The Partnership Committee has proven to be an effective way for union and management to work together to accomplish objectives in a timely and effective manner.

101. Administrative Services: Implemented a pilot project that co-located Administrative Officers (AO's) from their Division to specific program offices to improve administrative support through easier access to the AO by management and staff they service. As a result of the success of this pilot, the Center has permanently co-located the AO's to provide each organizational unit within CFSAN direct access to skilled and experienced administrative support on a day-to-day basis.

102. Recruitment and Hiring: Enhanced ability to recruit and hire candidates by finalizing a "Strategic Recruitment Plan." The Plan sets forth goals, objectives, and procedures for recruiting and retaining qualified scientific and professional personnel. As a result of this Plan, CFSAN implemented a variety of aggressive recruitment initiatives including, through June 1, 2001, attendance at approximately 9 job fairs throughout the country, mailings to approximately 500 Colleges and Universities, and successfully hiring 56 new employees of diverse backgrounds.
     

103. Automated Personnel Tracking: In support of the "Strategic Recruitment Plan," developed and implemented an automated personnel tracking system that enables CFSAN to promptly respond to and make final selection of applicants.

104. Hiring - Food Additive Premarket Review Program: Continued hiring initiative for the food additive premarket review program as a result of the additional funds received in the FY 2000 budget allocation. Twenty-six new employees were hired in FY 2001 (23 professionals and 3 office automation personnel), in addition to the twelve who were hired in FY 2000. A significant portion of the new hires (17/38) are from under-represented groups. Success in recruiting and hiring qualified candidates from under-represented groups was recognized through the awarding of the CFSAN Equal Opportunity Achievement Award "For superior efforts to incorporate the principles of equal opportunity and a diverse workforce in recruiting for the Food and Color Additive Review Program" to the recruiting team in the Office of Food Additive Safety (OFAS). Approximately 20 more employees will be hired in OFAS in FY 2002.

105. Career Development: Completed three milestones necessary for implementation of the Individual Development Plan (IDP) program in FY 2002: (1) Trained supervisors on the various types of professional development programs available for employees; (2) trained supervisors on federal staffing procedures; and (3) completed a 6-month mentoring "pilot" program with 8 mentor/mentee pairs. Results of this pilot will be used to make improvements to the IDP program prior to its implementation in FY 2002.

106. Employee Training: Developed two new courses for integration into the core training for CFSAN staff: (1) The Research/Regulations Roundtables explore the interaction of scientific research and the regulations development processes; and (2) The Successions Series which has as its goal to help maintain institutional memory by bringing back former FDA'ers to lecture, lead discussions, and give workshops.

107. New Employee Training: Implemented web-based training for new hires as part of the New Employee Orientation Program.

108. Hispanic Initiative: In accordance with Executive Order 13171, developed an Action Plan aimed at improving career development opportunities for Hispanic employees and recruitment of qualified Hispanic applicants.

1. Imported Food - Guidance on Destruction

2. Vibrio vulnificus - Respond to Citizen Petition

3. Egg Safety Standards - Proposed Rule

4. Food Contact Substances - Final Rule

5. Food Contact Substances - Guidance Documents

6. Premarket Notification Program - Report to Congress

7. Trans Fatty Acids - Final Rule

8. Good Manufacturing Practices for Dietary Supplements - Proposed Rule

9. Dietary Supplement Adverse Event Reports - Expedite Review

10. FY 2000 Spending on Dietary Supplements - Report to Congress

11. Cost to Implement Dietary Supplement Strategic Plan - Report to Congress

12. Alpha Hydroxy Acids - Labeling Guidance

13. Diethanolamine (DEA) - Risk Assessment

14. Enforcement Actions for Cosmetic Products - Memorandum of Understanding with the Center for Drug Evaluation and Research

15. Issuance of § 740.10 Warning Letters for Cosmetics - Draft Guidance

16. Voluntary Cosmetic Registration Program - Implement Web-Based System

17. Allergenicity of Bioengineered Food - Draft Guidance

18. BSE - Agencywide Proposed Rule to Ban Certain Bovine Materials

19. Chronic Wasting Disease - Proposed Rule in Collaboration with USDA

CFSAN 2001 Program Priorities

Hypertext updated by dav/kwg 2002-FEB-01