U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
December 5, 2000


CFSAN 2000 Program Priorities
Report Card


Dear Colleague, FDA Foods Community:

As promised, I am pleased to provide you with the end-of-the-year "Report Card" on our 2000 program priority accomplishments for FDA's foods program. I am even more pleased to tell you that we exceeded our productivity goal. As you may recall, in order to align our program priorities with the federal budget cycle, we condensed implementation of the 2000 workplan into three-fourths of the year (nine months). Accordingly, our goal was to fully complete at least three-quarters of the "A" list activities. As you will see, we exceeded this goal by completing 78% of our "A" list goals (84 out of 108 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. This record also demonstrates that we have increased productivity over what we accomplished last year – i.e., we completed more items this year in just nine months as we completed in 12 months last year. (73 out of 83 "A" list activities were completed in calendar year 1999.) Moreover, while there were too few "B" list accomplishments to highlight in last year’s "Report Card," I am pleased to report that this year, we completed 21 "B" list activities as well (Appendix A). So, the system is working!

Four major program areas dominated in 2000: (1) food safety; (2) food additives; (3) dietary supplements; and (4) food biotechnology. We have highlighted for you our most significant accomplishments in these areas, followed by an item-by-item description of each of the 84 "A" List and 21 "B" List activities. These follow the same order as they appear in the original Program Priorities Plan for 2000 ("Yellow Book").

I also want to acknowledge that twenty-four goals in the Program Priorities document were not fully completed before the end of fiscal year 2000; however, substantial progress was made on each of these goals. These goals will be carried over to our 2001 workplan and their completion will be a high priority for FY 2001. They are listed in Appendix B.

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, 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

Enclosure

2000 CFSAN Program Priority Report Card
Final Grade: Exceeded Goal*
Reporting Period January 1 - September 30, 2000

Accomplished

  1. Import inspection protocol
  2. Foreign Inspections
  3. 1,000-sample survey of imported produce
  4. Imports Report to Congress**
  5. Timely Testing of Produce Imports
  6. High-risk Domestic Food Inspections
  7. Evaluation of State Programs
  8. Food Recalls Report to Congress
  9. Seafood HACCP
  10. Dairy HACCP
  11. Produce - Evaluate Adoption of Sprout Guidance
  12. Produce Sampling Assignment
  13. Fruit/ Vegetable Agricultural Survey
  14. Food Code - Resolve issues with the 1999 Food Code
  15. Food Code - Increase adoption of the Food Code
  16. Outbreak Response traceback investigations
  17. Outbreak Response - Salmonella enteriditis
  18. Guidelines for Coordinating Outbreaks
  19. Seafood Parasites Survey
  20. Harmonize Standards for E.coli O157:H7
  21. GAPs - Producer Education & Outreach Program
  22. Sprout Video
  23. FSI Foreign Outreach and Education
  24. Food Safety Report to Congress**
  25. Fresh - Stakeholders Meeting
  26. Application Review (Expedited Review)
  27. Application Review (F/C Petitions - routine review)
  28. Application Review (F/C Petitions - reduce backlog)
  29. Application Review (biotechnology consultations)
  30. Application Review (GRAS Notifications)
  31. Application Review (PNM's)
  32. Food Contact Substances - Guidance
  33. Food Contact Substances - Proposed Rule
  34. Food Contact Substances - NEPA Requirements
  35. Food and Color Additives - Public Outreach
  36. Simultaneous Review of Meat and Poultry - MOU
  37. Simultaneous Review of Meat and Poultry - Final Rule
  38. Infant Formula Premarket Notifications
  39. Nutrient Content/Health Claim Submissions
  40. Enforcement Procedures - Food Label
  41. Dietary Supplement Safety Issues - Aristolochic Acid
  42. Dietary Supplement Safety Issues - NAS Study
  43. Ephedra - Public Availability of AERS
  44. Public Availability of Dietary Supplement AERs - Reduce Backlog
  45. Dietary Supplement Premarket Notifications - 75-day
  46. Dietary Supplement Routine Compliance
  47. Structure/Function Claims
  48. Pearson v. Shalala
  49. Health Claims - Folic Acid and Neural Tube Defects
  50. Health Claims - Fiber and Cancer
  51. Health Claims - Omega-3 Fatty Acids and CHD
  52. Claims for Mitigation of Disease
  53. Health Claim Petitions
  54. Dietary Supplement Strategic Plan
  55. Advisory Committee on Dietary Supplements
  56. Implementation of the Food Quality Protection Act
  57. Patulin
  58. Pesticide Monitoring Improvements Act (PMIA)
  59. Fumonisin Workshop
  60. Fumonisin Guidance
  61. Bottled Water Feasibility Study - Draft
  62. Bottled Water Feasibility Study - Final
  63. AHAs - Support NTP Testing
  64. Beta Hydroxy Acids - Support NTP Safety Study
  65. Streamline Voluntary Cosmetics Registration Program
  66. Participation Incentives for Cosmetics
  67. External Peer Review of Science Program
  68. Report of the Research Management Task Force
  69. MOD 1 - Report and Implementation Plan
  70. Professional Development
  71. Restructure CFSAN Food Advisory Committee
  72. Codex Committees and Working Groups
  73. WHO - Cooperation on Food Safety
  74. Biotechnology Strategy
  75. Conduct Meetings on Food Allergens
  76. CFSAN Relations with the Office of Regulatory Affairs (ORA)
  77. Regulations Process
  78. Communications
  79. "New Day"
  80. Implement the National Treasury Employees Union Contract
  81. Recruitment and Hiring
    - - - - - - 3/4 Point - - - - - - - - - - *
  82. New Employee Training
  83. Integrated Financial Management System
  84. College Park - Information Sharing and Action Plans

    Total: 84 Goals Accomplished


Substantial Progress
High Priority for FY2001

  1. Administration's Food Safety Strategic Plan
  2. Egg Safety Labeling and Refrigeration - Final Rule
  3. Egg Safety Standards - Proposed Rule
  4. Imported Foods Action Plan Initiatives
  5. Juice HACCP - Final Rule
  6. Seafood HACCP Program Evaluation
  7. Listeria monocytogenes - Risk Assessment
  8. Listeria Action Plan
  9. Vibrio parahaemolyticus - Risk Assessment
  10. Vibrio vulnificus - Respond to Citizen Petition
  11. Trans Fatty Acids - Final Rule
  12. "Healthy" - Respond to Citizen Petition
  13. Good Manufacturing Practices for Dietary Supplements - Proposed Rule
  14. Ephedra - Overall Strategy
  15. Health Claim: Antioxidant Vitamins and Cancer
  16. Alpha Hydroxy Acids - Labeling Guidance
  17. Diethanolamine (DEA) - Final Risk Assessment
  18. Declaration of Carmine and Cochineal Extract - Proposed Rule
  19. Strategy for Issuance of 740.10 Warning Letters
  20. Strategy for Issuance of Untitled Letters
  21. Equivalence Criteria
  22. Integrated Adverse Events Reporting System
  23. CFSAN Bioterrorism Plan
  24. Common/Usual Names for Several Species of Crab - Final Rule

    Total: 24 Carryover Priorities

* Because this plan covered a 9-month period, or 3/4 of the year, CFSAN's goal was to complete 75% of objective
** Goal completed but awaiting Administration clearance


CFSAN 2000 Program Priorities
Report Card

    Highlights
  1. FOOD SAFETY INITIATIVE
    2.
  2. MAJOR PROGRAM AREAS
    3.
  3. CROSS CUTTING AREAS
    4.
  4. APPENDICES
    5.  Appendix A -- "B" list Accomplishments
    Appendix B -- Goals Where Substantial Progress Was Made, But Completion To Be Carried-Over In 2001 Program Priorities
Highlights:
2000 Program Priority Accomplishments

General:

Food Safety:

Food Ingredients:

Dietary Supplements:

Biotechnology:

Additional Accomplishments:


Part I. Food Safety Initiative

Imports

  1. Import Inspections Protocol: In cooperation with the Office of Regulatory Affairs (ORA) finalized a standardized inspection protocol. Distribution of the final standardized inspection protocol to CFSAN management and Program Offices and appropriate ORA personnel began in mid-September, 2000.

  2. Foreign Inspections: In FY 1999 FDA conducted 85 inspections of foreign food establishments. FDA nearly doubled the number of inspections by conducting 165 inspections of foreign food establishments in FY 2000.

  3. Imported Produce Sample Survey: Completed the collection and laboratory analysis of 1000 samples of high volume imported produce.

  4. Imported Foods Report: In accordance with House Report 106-157, prepared a report to Congress on activities undertaken to improve coordination and cooperation with the U.S. Customs and in the inspection and regulation of imported foods. The report is currently undergoing final Administration clearance.

  5. Timely Testing of Produce: Reviewed and approved for use by field laboratories a number of rapid methods for detection of pathogens in imported produce.

Domestic Inspections

  1. High-Risk Food Inspections: In FY 2000, the number of "high-risk" food inspections was approximately 5700 compared to approximately 3000 for FY 1999 (increase of 90% over 1999).

  2. Evaluation of State Programs: Announced comprehensive strategy to enhance FDA evaluation of state inspection programs, to be implemented over 3 years. Developed a "State Contracts Audit Course" to train FDA field personnel to audit establishment inspections that were conducted through FDA’s State contract program. The first state contract audit course was held in October (Maryland) with two additional offerings to be held in November (SW/US) and December (NW/US).

  3. Food Recalls Report: In accordance with Senate Report 106-80, submitted a report to Congress on April 22, 2000 regarding food recall activities.

HACCP

  1. Seafood HACCP: Conducted third year of seafood HACCP inspections. FDA sent 148 seafood HACCP Warning Letters. The agency pursued the first seafood HACCP injunction against a purveyor of hot and cold smoked fish because the firm was not controlling the hazard of Clostridium botulinum. The firm entered into a consent decree and agreed to stop processing until this hazard could be controlled.

  2. Dairy HACCP: In collaboration with the National Conference of Interstate Milk Shippers, initiated a Dairy Grade A HACCP Pilot Program in six dairy processing plants. The six pilot plants have implemented the voluntary HACCP Pilot and were listed in the Interstate Milk Shippers List under the HACCP alternative to the traditional PMO-based program. The National Conference of Interstate Milk Shippers (NCIMS) HACCP Pilot Evaluation Team has completed information gathering activities at the six pilot plants and is preparing a report of findings and recommendations that will be presented to the NCIMS HACCP Committee.

Produce

  1. Sprout Guidance: In April, 2000, issued a field assignment to visit 150 sprout growers in the US to determine the extent to which the industry is adopting the sprout guidance. Agency field staff finished the initial inspections of those firms and are compiling results of those inspections. Preliminary evaluation indicates mixed results. The positive side is that the added testing is identifying some contaminated sprouts before they reach consumers, and there were fewer outbreaks from sprouts in FY 2000 compared to prior years. However, nearly half the sprout growers had not adopted effective preventive controls, in particular, microbial testing of spent irrigation water. Warning letters were sent to firms not adopting effective preventive controls and/or operating under unsanitary conditions. On October 18, FDA had a meeting with the industry to discuss barriers to implementation of the guidance. A final report of the assignment will be issued in FY 2001.

  2. Produce Sampling Assignments: On May 10, 2000, issued the Domestic Produce Sampling Assignment. The assignment requests collection of 1,000 samples of eight domestically produced fresh fruits and vegetables to determine the incidence of microbial contamination. As of October 3, 2000, 312 samples had been collected and 277 analyses completed.Seven samples were positive, indicating an apparent positive percentage of 2.5%. A copy of the assignment is available on CFSAN’s web site (www.cfsan.fda.gov/~dms/prodsur2.html).

  3. Produce Survey: To measure adoption of the GAP/GMP guidance, FDA worked with USDA’s National Agricultural Statistical Service (NASS) to perform an extensive survey of production practices of fresh fruit and vegetable growers and packers in the U.S. This survey gathered data on the types of practices (e.g., agricultural water source, manure use, employee hygiene and facility sanitation) covered in the guide. A report of the survey results is expected to be available early 2001. Repeating the survey in the future will allow FDA to measure changes in practices.

Food Code

  1. Conference of Food Protection: In August 2000, CFSAN representatives met with the Conference for Food Protection (CFP) Executive Board to discuss and resolve controversial Food Code provisions. Final decisions on those controversial issues of the 1999 Food Code will be integrated into the 2001 Food Code.

  2. Food Code Adoption: State agencies having jurisdiction over retail-level establishments in 20 states have adopted the Food Code. This exceeds our goal to achieve adoption of the Code by 35 percent of states (18 states).

Outbreak Response

  1. Outbreak Response [traceback investigations]: In conjunction with ORA, two documents were developed: the "CFSAN Emergency Response Procedures" and the "White Paper: Food & Cosmetics Emergencies." Both documents are being distributed to the ORA field and headquarters components.

  2. Outbreak Response [Salmonella enteritidis]: Evaluated Salmonella enteritidis protocol in light of general protocol, and concluded that the Salmonella enteritidis protocol needed to be revised. A draft "Salmonella enteritidis" Traceback Investigation Protocol" has been developed. The protocol is scheduled for completion in FY 2001.

  3. Outbreak Response Coordination: A document titled: "Multi-State Foodborne Outbreak Investigation: Guidelines for Improving Coordination and Communication" has been developed. It was distributed to stakeholders on May 24, 2000. The National Food Safety System Outbreak Coordination Workgroup will continue to meet to address the comments of the stakeholders. The final document is scheduled for completion in FY 2001.

Risk Assessment and Risk Identification

  1. Seafood Parasites Survey: FDA asked the American Gastroenterologist Association (AGA) to survey its members to determine the incidence of gastroenterological parasitic infections in the United States as a result of consumption of raw fish. A sample of 1000 members of the AGA have been selected. The sample allocation is designed to yield 500 completed surveys from member gastroenterologists practicing in states bordering the Atlantic and Pacific Oceans and the Gulf of Mexico. The survey data will be used to determine the actual frequency of occurrence of fish-borne helminth illnesses. This information will help the Agency better evaluate the need for control of helminth parasites in fish intended for raw consumption and to evaluate effective means for control where controls are found necessary. Results of the survey will be completed in FY2001.

  2. Harmonize Standards for E. coli O157: H7: FDA, in conjunction with USDA, provided funding for a pilot project with eight federal, state and local laboratories to develop standards for sampling and testing methods for E. coli 0157:H7. This pilot is taking E. coli O157:H7 food sample testing already ongoing at eight labs and standardizing their methods, as well as working toward accreditation of the procedures used. The pilot will be completed in FY 2001.

Risk Communication Education and Training

  1. Good Agricultural Practices: In collaboration with USDA, funded a grant to Cornell University to develop a Producer Education and Outreach Program, a training program on Good Agricultural Practices for domestic growers. Training programs have been held throughout the U.S. A related program has been developed through JIFSAN for international growers. The preliminary program was tested in Chile in June 2000.

  2. Sprout Video: In collaboration with the California Department of Health Services, the Sprout industry and ORA, developed a video to assist the industry in producing safer sprouts. The video was made available to the public in June 2000.

  3. FSI Foreign Outreach and Education: The U.S. - Chile Seminar on Food Safety entitled "An Integrated Food Safety System; Processes and Partnerships" was held on June 2, 2000. JIFSAN in conjunction with the Government of Chile held a training program on produce safety, emphasizing good agricultural practices (GAPs) on June 5 - 9, 2000. FDA also conducted dairy farm sanitation and milk safety training, emphasizing on-farm practices, on August 7 -11, 2000 in San Salvador, El Salvador. Proceedings of the outreach meetings in Chile and Mexico were completed and placed on the Web. The posting was unique for CFSAN in that it included videos of the presentations. The availability of this posting was widely publicized through constituent updates, the Agricultural Research Library, and through food safety education publications. Foreign outreach and education was continued by co-sponsoring a regional food safety meeting in Auckland, New Zealand on August 15-16, 2000.

  4. Food Safety Report: In accordance with Senate Report 106-80, in consultation with the U.S. Department of Agriculture, prepared a report to Congress on how to educate the public about the safety of our food supply. The report is currently undergoing final Administration clearance.

  5. Fresh: Held a public meeting in Chicago, IL on July 21, 2000 to discuss the use of term "fresh" in the labeling of foods processed with alternative non-thermal technologies. The purpose of this meeting was to solicit views on whether the use of the term "fresh" is truthful and non-misleading on foods processed with these alternative technologies and on what type of criteria FDA should use when considering the use of the term with future technologies.


Part II. Major Program Areas

Premarket Review of Food and Color Additives and Food Ingredients

Application Review Goals:

  1. Expedited Review: Completed the safety evaluation in less than 360 days for all five food and color additive petitions that qualified for expedited review. This exceeds our goal to complete 80-90% of these petitions within 360 days. A list of pending and completed petitions eligible for expedited review is available on our web site at the subheading, "Technical Documents for Industry," under the Food Additives and Premarket Approval program heading.

  2. Non-expedited Review Petitions: Completed the safety evaluation in less than 360 days for 77% (59 of 77) of food and color additive petitions that did not qualify for expedited review. This exceeds our goal to complete 50 – 60% of these petitions within 360 days.

  3. Reduce Backlog: Action was taken on 11 of 25 petitions (nearly 50%) that were more than 4 years overdue at the beginning of the fiscal year.

  4. Biotechnology Consultations: Six biotechnology notifications were received in FY 2000. Three biotechnology notifications were completed in FY 2000 with the initial review taking 4-5 months.

  5. GRAS notifications: Responded to 23 GRAS notices, 4 within 90 days; 12 within 180 days; and 7 notices in greater than 180 days.

  6. Food Contact Substances: Action was taken on 82 of 83 (98.8%) food contact notifications in the FY 2000 cohort within 120 days.

  7. Food Contact Substances Guidance: Guidance for the industry on preparation of premarket notification for food contact substances published in the Federal Register on July 13, 2000 (65 FR 43377).

  8. Food Contact Substances Proposed Rule: A proposed rule to implement the premarket notification process for food contact substances published on July 13, 2000 (65 FR 43269).

  9. Food Contact Substances – NEPA Requirements: The direct final rule and companion proposed rule covering treatment of these notifications under the National Environmental Policy Act (NEPA) published in the Federal Register on May 11, 2000 (65 FR 30352, and 30366, respectively.) The effective date of the direct final rule was August 24, 2000.

  10. Food and Color Additives: On May 5, 2000, a notice was published in the Federal Register (65 FR 26215) requesting public comment on ways to improve the food and color additive petition review process based on new resources made available in the FY 2000 congressional appropriations. A "Dear Colleague" letter was issued on October 5, 2000 announcing specific steps being taken to improve the food and color additive petition review process. The letter also provides an interim progress report on the scope of changes that are anticipated in the premarket processes. A copy of the letter is available on our web page at www.cfsan.fda.gov/~dms/opa-stak.html.

  11. Simultaneous Review of Food Ingredients in Meat and Poultry: Published a memorandum of understanding to establish the working relationship to be followed by FDA and USDA/FSIS in responding to requests for the sanctioning of the use of food ingredients and sources of radiation subject to regulation by FDA and intended for use in the production of meat and meat food products (65 FR 33330, May 23, 2000).

  12. Simultaneous Review of Food Ingredients in Meat and Poultry: Published a final rule on the simultaneous review of food ingredients in meat and poultry (65 FR 51758, August 25, 2000).

Nutrition, Health Claims and Labeling

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

  2. Nutrient Content/Health Claim Submissions: CFSAN continues to meet its statutory obligations for nutrient content and health claim submissions. CFSAN published a final rule authorizing a health claim for soy protein and heart disease (21 CFR 101.82) on October 26, 1999. CFSAN completed the evaluation of two additional health claim petitions within statutory timeframes. One petition was for sterol esters and heart disease. The other was for stanol esters and heart disease. The agency issued an interim final rule authorizing these health claims on September 8, 2000 (65 FR 54686)(21 CFR 101.83).

  3. Enforcement Procedures: CFSAN established procedures to evaluate food label complaints and respond to significant or precedent setting discrepancies in food labeling.

Dietary Supplements

  1. Safety Issues - Aristolochic Acid: Issued a letter to industry on May 16, 2000, and a separate letter to health care professionals on May 31, 2000, to communicate our concern about the use and marketing of dietary supplements or other botanical-containing products that may contain aristolochic acid. FDA issued an Import Alert on these products on July 6, 2000. Copies of all three documents are available on CFSAN’s home page.

  2. Safety Issues - NAS Study: Contracts were arranged with the National Academy of Science’s Institute of Medicine to establish a scientific framework for assessing the safety of dietary supplements, and to apply that framework to several specific dietary supplement products.

  3. Ephedra: Published three Federal Register notices announcing the availability of new adverse event reports and related information on dietary supplements containing ephedrine alkaloids, and announcing withdrawal of the provisions of the ephedrine alkaloids proposed rule relating to the dietary ingredient level and duration of use limit for these products (65 FR 17474 – 17510; April 3, 2000). On May 23, 2000, informed Congress that the report requested on the Agency’s methodology to be used in Ephedra rulemaking was no longer necessary as certain portions of the proposed rule had been withdrawn by FDA. Participated in a public meeting on August 8 – 9, 2000, sponsored by the Public Health Service, to discuss the available information about the safety of dietary supplements containing ephedrine alkaloids.

  4. Public Availability of Adverse Event Reports: At the beginning of this fiscal year, the Freedom of Information (FOI) backlog included requests for SN/SEMS information that date from 1998. This backlog consisted of 53 requests (790 adverse events), with each request averaging twenty separate adverse event records. Single records vary from one page to over a thousand pages. In August 2000, the backlog from 1998 - 1999 was essentially eliminated and remains up to date at present. Resources are currently being devoted to FOI requests received in the year 2000. The purchase and update of equipment and the provision of additional staff via contract and "detail" assignments accomplished this work. The information provided via these requests benefit consumers, health professionals and industry by providing timely information on potential adverse events associated with dietary supplement products.

  5. Notifications: CFSAN received twenty-four notifications for new dietary ingredients. All were reviewed within the statutory timeframes. Of these 24 notifications, nine were filed without comment (i.e., FDA did not object at the time of the review to its marketing); 15 were objected to either because they had inadequate information to provide a basis that it will reasonably be expected to be safe (11) or because they failed to meet procedural requirements in 21 CFR 190.6 (2). The remaining 2 were not dietary supplements.

  6. Routine Compliance: The Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Drug Evaluation and Research (CDER) have agreed that CFSAN should have lead responsibility in a streamlined case development process for cases where a dietary supplement carries a "disease claim" instead of a "structure/function" claim. That agreement is being memorialized in a memorandum of understanding (MOU) between the Centers.

  7. Structure/Function Claims: Published a final rule that defines the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body (65 FR 9999; January 6, 2000). Participated in FDA public meeting addressing pregnancy-related claims under the structure/function rule. During the period January 2000 through October 2000, FDA received approximately 1,400 structure/function notifications. After reviewing the notifications, the agency sent 102 letters to firms notifying them that the claims for one or more of the products that were the subject of their notifications were not structure/function claims, but were disease claims not permitted for use in the labeling of dietary supplements pursuant to section 403(r)(6) of the FD&C Act.

  8. Pearson v. Shalala: Published Federal Register notice on the strategy for responding to petitions for health claims for dietary supplements, including the health claims at issue in Pearson (65 FR 59855; October 6, 2000). Held a public meeting on April 4, 2000 to solicit comments on implementation of the Pearson decision.

  9. Health Claim Regarding Folic Acid and Neural Tube Defects: On October 10, 2000, issued a final determination on one of the four Pearson claims. FDA determined that the proposed claim that stated 0.8 mg of folic acid in a dietary supplement was more effective in reducing the risk of neural tube defects than a lower amount in foods was not authorized. Although FDA determined that this claim could not be appropriately qualified without being misleading, the agency did provide examples of appropriate qualified claims. A copy of this letter is available on our home page at www.cfsan.fda.gov/~dms/ds-ltr7.html.

  10. Health Claim Regarding Fiber and Colorectal Cancer: On October 10, 2000, issued a final determination on a second of the four Pearson claims. FDA determined that the proposed health claim about dietary fiber and reduced risk of colorectal cancer could not be authorized because the results of studies about dietary fiber consistently showed a lack of relationship between dietary fiber supplements and the risk of colorectal cancer. Neither could the claim be qualified because the suitable evidence against the claim outweighed the evidence for it. A copy of this letter is available on our home page at www.cfsan.fda.gov/~dms/ds-ltr8.html.

  11. Health Claim Regarding Omega-3 Fatty Acids and Coronary Heart Disease: On October 31, 2000, issued a final determination on the third of four Pearson claims. FDA is using its enforcement discretion to allow a qualified claim about the use of omega-3 fatty acids in dietary supplements and the reduced risk of coronary heart disease. The qualified claim applies to daily intakes that do not exceed three grams per person per day from conventional food and dietary supplement sources.

  12. Claims for Mitigation of Disease: Following a public meeting, on May 26, 2000, denied a petition requesting authorization of a health claim concerning the relationship between dietary supplements containing saw palmetto and benign prostatic hyperplasia (BPH). FDA’s response noted that claims about effects on existing diseases do not fall within the scope of the health claim provisions of the Act and therefore may not be the subject of an authorized health claim.

  13. Health Claim Petitions: CFSAN continues to meet its statutory obligations for health claims for dietary supplements. CFSAN denied, by operation of the statue (on December 1, 1999) and formally on May 26, 2000, a health claim for saw palmetto extracts and symptoms of BPH. CFSAN also denied on January 11, 2000, a petition for vitamin E and heart disease due to lack of significant scientific agreement to support the claim.

  14. Dietary Supplement Strategic Plan: On January 3, 2000, the Dietary Supplement Strategic Plan was distributed to stakeholders and posted on the web page. The Plan establishes a clear program goal to have, by the year 2010, a science-based regulatory program that fully implements the Dietary Supplement Health and Education Act of 1994, and that provides consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products. This plan has been discussed at multiple public meetings during the year.

  15. Advisory Committee: A standing Dietary Supplement Subcommittee was officially added to the restructured Food Advisory Committee on June 26, 2000. A request for membership nominees having the requisite scientific expertise to serve on the new subcommittee appeared in the Federal Register on July 28, 2000 (65 FR 46463).

Chemical and Other Contaminants

  1. Implementation of Food Quality Protection Act (FQPA): Published draft guidance entitled, "Guidance for Industry – Channels of Trade Policy for Commodities with Methyl Parathion Residues," in the Federal Register on June 2, 2000 (65 FR 35376). The guidance presents FDA’s policy for foods containing methyl parathion residues in accordance with the "channels of trade" provision of FQPA. [NOTE: Based on EPA’s action on azinphos methyl, a "channels of trade" policy for commodities with azinphos methyl residues is not required.]

  2. Patulin: Published a draft compliance policy guide (CPG) entitled, "Apple Juice, Apple Juice Concentrates, and Apple Juice Products – Adulteration with Patulin," in the Federal Register on June 6, 2000 (65 FR 37791). The purpose of the CPG is to advise FDA’s field offices and the industry concerning enforcement actions that may be taken against apple juice products that contain patulin.

  3. Pesticide Monitoring Improvements Act (PMIA): FDA’s pesticide monitoring data and summary information was made available on the Internet, as required by PMIA, on May 18, 2000.

  4. Fumonisin Workshop: On January 12, 2000, in collaboration with the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the World Health Organization, convened an international workshop to consider all available risk assessment data on fumonisin.

  5. Fumonisin Guidance: Published draft guidance entitled, "Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds," in the Federal Register on June 16, 2000 (65 FR 35945).

  6. Draft Bottled Water Feasibility Study: Solicited comments on the draft feasibility study in the Federal Register of February 22, 2000 (65 FR 8718).

  7. Final Bottled Water Feasibility Study: Published in the Federal Register of August 25, 2000 (65 FR 51833), a final report on the feasibility of appropriate methods of informing customers of the contents of bottled water, as required by the Safe Drinking Water Act (SDWA) Amendments.

Cosmetics

  1. Photocarcinogenicity Testing of Alpha Hydroxy Acids (AHA’s): CFSAN participated in a meeting of the Toxicology Study Section and Review Committee (TSSRC) convened to evaluate progress and report on the testing of AHA photocarcinogenicity sponsored by the National Toxicology Program (NTP).

  2. Beta Hydroxy Acids: CFSAN participated in a meeting of the Toxicology Study Section and Review Committee (TSSRC) convened to evaluate NTP sponsored safety study of Beta Hydroxy Acids.

  3. Streamline Voluntary Cosmetics Registration Program (VCRP): Programming for an online, interactive system for streamlining the VCRP is complete. The system is awaiting the installation of a "T3" high speed communication line before undergoing beta testing, any necessary modification, and final implementation. The installation and testing of the "T3" line have been slowed by a Washington, DC, moratorium on fiber optic installation due to the heavy amount of road damage necessary for the work.

  4. Participation Incentives: Evaluated a variety of incentives to encourage participating in the registration program. Candidate incentives determined to be feasible within the current structure of the VCRP include providing a "Certificate of Participation" or letter of acknowledgement; establishment of a participant e-mail list for receiving information from the agency; and posting of company names and brand names on the web. These, and other incentives, will be considered as the VCRP is shifted to an internet-based program.


Part III. Cross Cutting Areas

Science Base

  1. External Peer Review: On April 21, 2000, presented the External Peer Review Report to the FDA Science Board. The Science Board voted to accept the report. The report's recommendations are being implemented as outlined at that meeting.

  2. Research Management Task Group: The Task Group has completed two extensive reports, which recommend options for identifying research needs, planning research resources, planning research activity, tracking research resources, tracking research progress, reporting research activity, reviewing research activity, and terminating research activity. Implementation will occur in FY 2001.

  3. MOD-1 Task Group Report: The Task Group's report has been finalized, and a proposed office structure, staff allocation and functional statement has been developed and approved by the Agency. Effective August 14, 2000, Interim Director appointed to the new "MOD1 Office."

  4. Professional Development: Three training courses on risk communication were presented to Senior-level and Mid-level Managers. Groundwork was laid for creation of the CFSAN Staff College in FY 2001.

  5. Leveraging Scientific Expertise: To better respond to the increasing breadth of the scientific questions that must be addressed, FDA restructured the Food Advisory Committee to consist of a "parent" Committee and four standing Subcommittees: (1) Additives and Ingredients; (2) Contaminants and Natural Toxicants; (3) Dietary Supplements; and (4) Food Biotechnology. A request for membership nominees having the requisite scientific expertise to serve on the new subcommittees appeared in the Federal Register on July 28, 2000 (65 FR 46463).

International

  1. Codex Committees and Working Groups: Participated in 18 Codex committees and related meetings to promote development of harmonized food safety and labeling standards. Participation in the Ad-Hoc Task Force on Foods Derived from Biotechnology in July 2000, included participation in the Task Force's Working and Drafting Groups that are developing draft international Guidelines for the Safety Assessment of Foods Derived from Biotechnology. In June 2000, provided a leadership role for the Codex Committee on Nutrition and Foods for Special Dietary Uses in developing international Guidelines for Vitamin and Mineral Supplements.

  2. World Health Organization (WHO) - Cooperation on Food Safety: The World Health Assembly, under the auspices of the WHO, adopted a resolution on food safety by consensus of all countries. The resolution calls upon WHO to significantly strengthen its leadership role in food safety, particularly with regard to controlling foodborne diseases associated with microbial pathogens.

Emerging Areas

  1. Biotechnology: On May 3, 2000, made a public announcement on plans to strengthen the regulatory approach for bioengineered foods. Three initiatives were announced: (1) Development of a proposed rule requiring that developers of bioengineered foods notify the agency before they market such products; (2) the addition of scientists to the Food Advisory Committee that have expertise in biotechnology; and (3) the development of labeling guidance to assist manufacturers who wish to voluntarily label their foods being made with or without the use of bioengineered ingredients.

  2. Food Allergens: Held meetings at fourteen locations to raise consumer and industry awareness to the presence of allergens in foods and on labeling approaches to identify the presence of allergens.

Regulatory Processes

  1. CFSAN-Field Relations: CFSAN and ORA initiated a number of activities to improve FDA's foods program. Following a meeting of CFSAN/ORA Senior Managers on December 14, 1999, a CFSAN/ORA Taskforce was formed to strengthen working relations in six program areas: (1) budget and workplan; (2) outbreaks and tracebacks; (3) inspections and field programs; (4) international programs; (5) enforcement; and (6) laboratories. In addition to the Task Force activities, CFSAN met with/hosted a number of joint CFSAN/ORA meetings aimed at improving efficiencies and effectiveness of the foods program. These include a meeting with the Field Food Committee on June 6 - 8; a meeting with representatives of field laboratories on June 28 - 29; a meeting with ORA headquarters and Field personnel on July 24 - 28; a foods program session at ORA's Senior Staff meeting on August 29; and a meeting with ORA's Field Directors of Investigations/Compliance and Laboratory Branch on September 18.

  2. Regulations Process: Standard Operating Procedures were developed and distributed for responding to citizen petitions, including development of denial letters; advanced notices of proposed rulemaking; proposed rules; and final rules. In addition, preliminary recommendations on improving the regulations process at CFSAN were developed. The Center is advertising for a Senior Regulations Manager.

  3. Communications: The Office of Field Programs (OFP) of the Center for Food Safety and Applied Nutrition developed an Intranet site in order to improve communication outreach efforts with the Field Offices, the states and other federal agencies. Additionally, two documenting systems to track both correspondence and case reports have been developed. In FY2001, CFSAN will move to centralize both tracking functions utilizing a single software.

Management Initiatives

  1. "New Day": Conducted mandatory conduct and performance training for all employees and mandatory performance management training for all supervisors as a first step towards implementation of the "New Day" in CFSAN.

  2. Implement the National Treasury Employees Union (NTEU) Contract: Worked with NTEU Leadership to ensure smooth implementation of the contract. The contract established a positive working relationship throughout CFSAN with regard to the following areas. (1) NTEU/Union Implementation - exchanged information, discussed issues and made recommendations e.g., awards, parking, alternative workplace program; (2) College Park - continuing to oversee the move to College Park and (3) Realignment - three reorganizations/realignments were completed in 2000.

  3. Recruitment and Hiring: CFSAN has finalized a Strategic Recruitment Plan. This plan, which sets forth goals, objectives, and procedures for recruiting and retaining qualified scientific and professional personnel, will be implemented in FY2001. A Personnel Management Specialist was hired in April 2000.

  4. New Employee Training: A new, WEB-based, CFSAN Employee Orientation Program has been developed and will be utilized for new employees, in FY2001.

  5. Integrated Financial Management System (FMS): Established connectivity with the Agency through the center's new Hyperion Financial Management System. Downloads are being analyzed to insure financial integrity. Minor software problems continue to be corrected. Reports are being written to extract operating data and payroll in requested formats. Preliminary reports are in review and additional reports under development.

  6. College Park: CFSAN is fully involved in the planning for the move to its new facilities at College Park, Maryland. Working in partnership with the employees union (NTEU), task groups have been formed to handle the details of laboratory and office moves, contract support for basic services, information technology transfer, and records management practices to transition the organization to the new facilities. An intensive information sharing effort has been mounted with bi-monthly updates with the most up-to-date information on the move.


Appendix A
CFSAN 2000 Program Priorities - "B"
List Accomplishments

Food Safety Initiative

  1. Evaluated and updated the 3-year Research Plan to ensure that the research projects the Center is performing provide a strong scientific basis for our regulatory mission.

  2. Updated "Bad Bug Book" on the Internet. The "Bad Bug Book" provides basic facts regarding foodborne pathogenic microorganisms and natural toxins.

  3. Updated and posted the First Six Chapters of the BAM Manual on the Internet. The Bacteriological Analytical Manual (BAM) is published in collaboration with AOAC International and provides analytical methods for the detection of microorganisms and certain of their metabolic products.

  4. Completed development of the survey instrument for the Food Safety Consumer Survey Cycle IV. The survey is used to monitor the impact of food safety initiatives and to identify consumer education needs.

Premarket Review of Food and Color Additives and Food Ingredients

  1. We exceeded our goal and placed six new chapters of the "Redbook" (Toxicological Principles for the Safety of Food Ingredients) on the CFSAN Worldwide Website. The electronic version can be found on CFSAN's Web Site (http://www.cfsan.fda.gov/~redbook/red-toca.html).

Nutrition, Health Claims and Labeling

  1. Publish a notice of availability on citizen petition 99P-2630 requesting that FDA establish a daily reference vale for added sugars and that FDA list added sugars in the Nutrition Facts panel.

Dietary Supplements

  1. Enhanced collaborations with FTC on labeling issues. CFSAN and the Federal Trade Commission have established a process for the mutual exchange of information on ongoing strategies and specific policy and enforcement actions. ONPLDS continues to meet on a routine basis with FTC and plans on additional and regular collaborations.

  2. Incorporated compliance with new labeling regulations into inspection program.

  3. Continued to review 30-day postmarket notifications for supplement claims in a timely manner.

  4. Developed database for 30-day label claim notifications and courtesy letters. During this past year, ONPLDS and OMS have initiated a limited trial program to assess the 30-day document management and retrieval system. To date, over six hundred (600) 30-day reports have been scanned into the database.

  5. Identify ways to leverage resources to address dietary supplement issues and research needs. Leveraging was accomplished for a number of dietary supplement topic areas. In the area of research, formal meetings with both NCTR and USP were instituted and work toward a CRADA with the Univ. of Mississippi was initiated. Contracts were arranged with the NAS’s Institute of Medicine to address dietary supplement safety and the scientific framework for health claims on dietary supplements. Formal routine meetings with NIH’s Office of Dietary Supplements as well as the Federal Trade Commission were instituted; increased interaction with NIH’s Center for Complimentary and Alternative Medicines is planned. A contract was finalized to develop a guidebook for industry on commonly asked questions concerning regulation of dietary supplements.

  6. Recruit pharmacognosy expertise in headquarters. An interdisciplinary scientist position description was created, approved and widely advertised. Interested individuals submitted applications for consideration between August 21 and October 4. The Center is seeking specific expertise in the areas of new dietary supplements and botanical products.

  7. Disseminated information kits for FDA field staff and instituted regular updates with field staff.

  8. Communicated dietary supplement enforcement policies and procedures to the general public, FDA field offices, health care professionals, and industry. ONPLDS has met with several organizations to share information concerning dietary supplement enforcement policies and procedures. For example: Food and Drug Law Institute - a panel discussion on dietary supplements; Virginia Department of Agriculture and Baltimore/Richmond Resident Post - an enforcement training program; Kentucky Health Department - a seminar on dietary supplements; AFDO Annual Meeting - presentations on dietary supplement enforcement and boundary issues; AFDO local chapter - enforcement; Nutrition 2000 Conference and EXPO East Annual Meeting - dietary supplement issues.

Cosmetics

  1. Updated and enhanced cosmetics WEB page.

  2. Continued to support EU-US bilateral program and the Cosmetics Harmonization and International Cooperation (CHIC) initiative. The continued support exists on several levels - Through formal meetings such as CHIC and the US-EU Bilateral meetings, direct contacts (mostly phone, e-mail and written contacts) and targeted meetings. For example, our EU counterpart was here in April for specific discussions on cosmetics and OTC drugs. There have also been exchanges of information at the technical and scientific level.

  3. Complete review of ingredient dictionary and began developing proposed regulation for cosmetic ingredient nomenclature.

Science Base

  1. Enhanced Visiting Scientist Program through the development of mechanisms to recruit and provide support for visiting scientists through JIFSAN/University of Maryland.

  2. Implement recommendations for the Scientific Manuscript Clearance Task Group.

Management Initiatives

  1. Continued to provide mechanisms for improved communication and quality of worklife by promoting Center programs, i.e. Employee Orientation, Leadership Assignment Program, Mentoring Programs, and widespread use of the Individual Development Plan to help employees be more productive and ensure that the mission of the Center is carried out.

  2. Provided an adequate infrastructure for new and existing IT systems and networks. Provided support to the Center through an upgraded and fully staffed Help Desk.


Appendix B
Goals Where Substantial Progress Was Made, But Completion To Be Carried-Over In 2001 Program Priorities

  1. Administration's Food Safety Strategic Plan
  2. Egg Labeling and Refrigeration – Final Rule
  3. Egg Safety Standards – Proposed Rule
  4. Imported Food Action Plan Initiatives
  5. Juice HACCP – Final Rule
  6. Seafood HACCP Program Evaluation
  7. Listeria monocytogenes – Risk Assessment
  8. Listeria monocytogenes – Action Plan
  9. Vibrio parahaemolyticus – Risk Assessment
  10. Vibrio vulnificus – Respond to Citizen Petition
  11. Trans Fatty Acids – Final Rule
  12. "Healthy" – Respond to Citizen Petition
  13. Good Manufacturing Practices for Dietary Supplements – Proposed Rule
  14. Ephedra – Overall Strategy
  15. Health Claim: Antioxidant Vitamins and Cancer
  16. Alpha Hydroxy Acids – Labeling Guidance
  17. Diethanolamine (DEA) – Risk Assessment
  18. Declaration of Carmine and Cochineal Extract – Proposed Rule
  19. Strategy for Issuance of 740.10 Warning Letters
  20. Strategy for Issuance of Untitled Letters
  21. Equivalence Criteria – Final Criteria
  22. Integrated Adverse Event Reporting System – Plan
  23. CFSAN Bioterrorism Plan
  24. Common/Usual Names for Several Species of Crab – Final Rule


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