Letter from Center
Director
Enclosure 1:
Accomplishments Through June 15, 2002
Enclosure 2:
Modifications to the FY2002 Workplan
Dear Colleague, FDA Foods Community:
As promised, I am pleased to report to you on the progress we are making towards implementing CFSAN's 2002 Program Priorities document. This document constitutes the Center's priority workplan for this fiscal year, October 1, 2001 - September 30, 2002.
First, we have fully completed 43 "A" list goals. These accomplishments are listed in Enclosure 1. Most notable among these are several activities focused on increasing the security of the nation's food supply: initiation of threat assessments; participation in a counter-terrorism "Table Top" exercise; development of proposed legislation that the Administration transmitted to Congress; and publication of food security guidance for domestic producers and importers. In addition, we continue to make significant progress on a broad range of food safety, food additive, and dietary supplement activities. I also call your attention to the substantial international leadership role that our Center's scientists are playing in Codex and other major global activities.
Second, I want to inform you about modifications we have made to our 2002 workplan. As a result of new priorities, we have added 18 activities to the "A" List. Enclosure 2 identifies these modifications. You will see that many of the additions are the result of further refinements to our food security strategies, and new legislation that was enacted by Congress since publication of our 2002 workplan -- specifically, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188), Enacted June 12, 2002, and the Farm Bill (P.L. 107-171), Enacted May 13, 2002. These areas will be further highlighted in next year's workplan. To make time for these new priorities, Enclosure 2 identifies 7 goals that have been moved to the "B*" list, so that final action should not be expected until next year.
Our goal continues to be to complete at least 90% of the "A" List items by the end of the current fiscal year, September 30, 2002. Keep in mind, however, that the precise timing of Federal Register publications is difficult to predict. Accordingly, any Federal Register documents that are not published by September 30th will be carried over to next year's workplan.
Lastly, I want to ask for your input as we begin to establish program priorities for fiscal year 2003. A notice soliciting comments on next year's workplan was published in the Federal Register on June 21, 2002 (67 FR 42272). Comments are accepted though August 21, and should be sent to the Dockets Management Branch (HFA-305), 5630 Fishers Lane, Rockville, MD 20852. Comments should be identified with docket number 98N-0359. The 2003 workplan will set forth the Center's program priorities for October 1, 2002 - September 30, 2003. This priority-setting process will continue to provide predictability, transparency, and accountability to our foods program, as we continue to build a World Class Organization.
In closing I believe we are making excellent progress on our 2002 program priorities, all for the benefit of American consumers. I will provide you with a final "Report Card" on our accomplishments in the fall. I welcome any feedback you may have, and encourage you to provide input into the development of next year's workplan.
| Sincerely,
Joseph A. Levitt Director Center for Food Safety and Applied Nutrition |
Initiated threat assessments to examine different categories of food for the relative risks of intentional contamination during various stages of food production and distribution. So that we do not provide a "blueprint for terrorists," the full reports of these assessments are being classified. FDA is currently exploring acceptable ways to share with industry appropriate information gleaned from the threat assessments.
Participated in a Counter-Terrorism "Table Top" exercise to evaluate emergency response capabilities in various simulated foodborne outbreak scenarios. The exercise was hosted by FDA's Office of Regulatory Affairs/Division of Emergency Operations.
FDA's Office of Regulatory Affairs has hired over 600 new food safety investigators and laboratory personnel in the field, the majority of which will be charged with monitoring food imports.
Developed proposed legislation that the Administration transmitted to Congress to (among other things) enable FDA to strengthen oversight of imported food and more quickly conduct traceback activities when illnesses associated with food are identified.
Met with over 35 industry groups and trade associations to discuss ways to enhance food security and ensure that rapid response and recovery processes are in place should food be deliberately contaminated. Participated in the Alliance for Food Security, a public-private partnership formed by the National Food Processors Association, that includes representatives of 83 businesses, government and other organizations dedicated to food safety and security.
Published guidance for domestic producers and importers on preventive measures to increase their preparedness and enhance the security of their products (67 FR 1224; January 2, 2002).
Enhanced coordination and communication with other Federal, state and local organizations in addressing food security issues through regular conference calls and periodic meetings.
Completed training sessions for all CFSAN employees on general national security issues pertaining to people, information and facilities.
In response to P.L. 107-76, The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2002, notified stakeholders about the labeling of catfish. A copy of the notification is available at www.cfsan.fda.gov/~frf/slcf2002.html. [NOTE: This has subsequently been superceded by language in the Farm Bill (P.L. 107-171), enacted May 13, 2002.]
Published draft juice HACCP 5-log reduction guidance (66 FR 65978; December 21, 2002). The purpose of this draft document is to provide guidance to juice producers about FDA's revised recommendations for effectively achieving a 5-log reduction in pathogens.
Conducted an education campaign for the egg labeling and refrigeration final rule. A new brochure, Assuring the Safety of Eggs and Menu and Deli Items Made from Raw, Shell Eggs, and a new poster, Key Temperatures for Egg Safety, were printed in large quantities for distribution through ORA. Initially, 250 copies of each were sent to State Egg Program Directors, State Food Service Program Directors, FDA Regional Food Specialists, and FDA Public Affairs Specialists. The brochure and poster have also been widely distributed at professional meetings and conferences. Lastly, before Easter and Passover, a mailing of CFSAN's consumer brochure, Playing it Safe With Eggs, with a cover letter relating egg safety to the season, was sent to health and food editors of 500 major daily newspapers.
Completed efforts to gather additional exposure assessment data on Listeria. The data came from the JIFSAN-NFPA Listeria Retail Food Study. Data represent the completion of 14 to 23 months collection and testing of the following selected ready-to-eat retail foods: sliced luncheon meats, prepared "deli"-style salads, seafood salads, bagged leafy salads, smoked seafood, fresh ("Hispanic-style") cheese, and soft mold-ripened or blue veined cheese. In total, 31,705 samples were tested; Listeria monocytogenes was detected at an overall prevalence of 1.82%. The data will be included in the FDA/USDA/CDC Listeria monocytogenes risk assessment.
On June 14, 2002, issued a field assignment for fresh soft, soft, and semi-soft cheeses to gather additional data for the Listeria risk assessment. Twenty samples of each of four types of cheese are to be collected for a total of 80 samples per district. Samples are to be collected from retail establishments to determine "worst-case" levels due to growth that may occur during distribution and storage after the product is transported from the manufacturers facility.
Achieved adoption of the Food Code in 30 states and one territory.
Published the 2001 revision of the Food Code. A few significant changes between the 2001 Food Code and the 1999 Food Code include: (1) A revised definition of juice, information on juice treated to control pathogens, and information that addresses issues relating to juice provided to populations that are particularly vulnerable to foodborne illness; (2) a revised definition of "highly susceptible populations;" and (3) new provisions for the refrigeration and labeling of eggs consistent with new requirements in the Code of Federal Regulations. Written requests for single copies of the 2001 Food Code may be sent to: Office of Field Programs (HFS-600); 5100 Paint Branch Parkway, College Park, MD 20740. The 2001 Food Code is also available on our web site at http://www.cfsan.fda.gov/~dms/foodcode.html
Developed a strategy for expanded monitoring, method development, and reducing human exposure to dioxins. A copy of this strategy is available at www.cfsan.fda.gov/~lrd/dioxstra.html. As part of this strategy, issued a dioxin field survey assignment to collect and analyze approximately 1000 food samples. Samples include: finfish and shellfish; aquaculture catfish; dairy products; fats and oils; cereal and grain products; and fruits.
Published a final "channels of trade" guidance document for industry on foods containing residues of the pesticide chemical vinclozolin (67 FR 40317; June 12, 2002).
Expanded the pilot training program conducted in FY 2001 on how field investigators should address food allergens during inspections. On October 5, 2001, training was provided via a satellite broadcast to all FDA and State regulators responsible for conducting food inspections in the U.S. The objective of the training was to review FDA's policy on food allergens, provide information on potential sources, and provide tools to assist investigators in performing effective and uniform allergen inspections.
Submitted a Report to Congress on FDA's plans to prevent cross-contamination of foods by undeclared allergens.
Continued international outreach by participating in joint USDA/FDA food safety education and training program in Brussels, Rome, Copenhagen, Paris, and Madrid (March 17 - 22, 2002).
For the petition receipt cohort of FY 2001, completed within 360 days of filing, the safety evaluation for two of the three food additive petitions that qualify for expedited review. A petition qualifies for expedited review if the food additive is intended to decrease the incidence of foodborne illnesses through its antimicrobial actions against human pathogens that may be present in food. A list of pending and completed petitions eligible for expedited review is available at www.cfsan.fda.gov/~dms/opa-expd.html.
Completed evaluation of the one biotechnology final consultation received in FY 2001 within 180 days. A list of all completed biotechnology consultations is available at http://www.cfsan.fda.gov/~lrd/biocon.html
Completed processing of 21 of 27 GRAS notifications in the receipt cohort of FY 2001 within 180 days. A summary of all GRAS notifications is available at http://www.cfsan.fda.gov/~rdb/opa-gras.html
Completed review of all (70) premarket notifications for food contact substances in the receipt cohort of FY 2001 within 120 days. A complete list of premarket notifications for food contact substances is available at http://www.cfsan.fda.gov/~dms/opa-fcn.html
Published the final food contact substance regulation (67 FR 35724; May 21, 2002).
Published a final food contact substance guidance document to assist industry in preparing notifications (67 FR 35826; May 21, 2002) and two final guidance documents to inform industry about the kind of toxicology and chemistry data that are needed for FDA's evaluation (67 FR 17703; April 11, 2002).
Published a notice extending until January 1, 2006, the partial stay of certain provisions of the nutrient content claim regulations pertaining to use of the term "healthy" (67 FR 30795; May 8, 2002).
Published a proposed rule to update the nutrient values for the voluntary nutrition labeling program (67 FR 12918; March 20, 2002). [NOTE: The document published with an incorrect docket number; a correction notice was published on June 6, 2002; 67 FR 38913].
Developed, "Tips for the Savvy Supplement User," to assist consumers in making informed decisions and evaluate information about dietary supplements. A copy is available at www.cfsan.fda.gov/~dms/ds-savvy.html. A Spanish language version is also available at http://www.cfsan.fda.gov/~dms/sds-savv.html
Submitted a Report to Congress on the estimated cost to implement the Dietary Supplement Strategic Plan. A copy of this report is available at http://www.cfsan.fda.gov/~dms/supplmnt.html
Issued a Consumer Advisory and letter to health professionals on the potential risk of severe injury liver associated with the use of Kava-containing dietary supplements. Copies of both documents are available at http://www.cfsan.fda.gov/~dms/supplmnt.html
Completed a Memorandum of Understanding with FDA's Center for Drug Evaluation and Research that allows the Office of Cosmetics and Colors to manage enforcement actions for certain cosmetic products whose label or labeling contains structure/function or disease claims.
Completed specialized renovations in the College Park building prior to occupancy.
Completed move of CFSAN personnel and associated laboratories to the new headquarters site in College Park, MD.
Conducted transition activities aimed at assisting employees in making a smooth transition from Washington, D.C. to College Park, MD. Transition activities included: (1) Maintaining two CFSAN "homes" during the 7-month move period by ensuring availability of administrative support, EEO, Employee Relations and Personnel in both locations; (2) conducted "Change Seminars" to help employees understand their response to the stages of change and express what they are experiencing about a change in their working environment; (3) developed a "Guide" for operating between buildings that addressed issues such as mail, shipping and receiving, and property management; (4) developed an Internal Operations Manual that addressed services such as administrative support, personnel, IT services, graphics, phones, and health unit; and (5) conducted Stress Management Seminars to help employees cope with situations that are perceived to be anxiety-inducing. [Note: One more "Change Seminar" will be scheduled for employees who are moving from Washington, D.C. to Chantilly, Virginia later this fiscal year.]
Developed a Strategic Plan for the Office of Research and Safety Assessment (OARSA) and presented the plan to the FDA Science Board. The Strategic Plan identifies 8 areas of research where OARSA will concentrate its efforts in the next five years.
Led U.S. delegation to the Codex Committee on Food Hygiene (CCFH), October 8 - 13, 2001 in Bangkok, Thailand. Under leadership of the U.S. delegation, the 34th Session of CCFH continued the paradigm shift of this Committee towards developing microbiological risk management guidance documents based on microbiological risk assessments undertaken by FAO/WHO Joint Expert Groups. Also important was the continuing work the Committee is undertaking in the development of Codex Commodity Codes of Hygienic Practice.
Led U.S. delegation to the Codex Committee on Food Additives and Contaminants (CCFAC), March 11 - 15, 2002 in Rotterdam, the Netherlands. The 34th session of CCFAC focused on a variety of issues including two discussion papers -- Application of Risk Analysis Principles for Food Additives and Contaminants, and Active Chlorine; draft revised standards for irradiated foods; ochratoxin, patulin and aflatoxins in food and feed; and industrial and environmental contaminants in foods such as lead, cadmium, tin, dioxin and chloropropanols.
Led U.S. delegation to the Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS), February 25 - March 1, 2002 in Brisbane, Australia. The U.S. delegation led a discussion of three main subjects: (1) development of a paper on traceability; (2) Draft Guidelines for the Judgment of Equivalence of Sanitary Measures Associated with Food Import and Export Inspection and Certification Systems; and (3) Draft guidelines or Food Import Control Systems.
Led U.S. delegation to the Codex Committee on Nutrition and Foods for Special Dietary Uses, November 26 - 30, 2001 in Berlin, Germany. The 23rd session of the Committee discussed draft guidelines on vitamin and mineral supplements; a revised standard for infant formula; and a proposed revised standard for processed cereal-based foods for infants and young children. The Committee also agreed that a risk-based approach should be followed for the establishment of upper limits for micronutrients and that the next session should be informed about the progress achieved by FAO/WHO and national scientific bodies in this area.
Led U.S. delegation to the Codex Ad-Hoc Intergovernmental Task Force on Foods Derived from Biotechnology, March 4 - 8, 2002 in Yokohama, Japan. Through the efforts of the U.S. delegation, the Task Force completed work on two major documents -- Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology and Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. The Task Force also identified a solution to two major issues -- how to handle traceability and how to construct an annex on assessing allergenicity of foods derived from biotechnology.
Led U.S. delegation to the Codex Committee on Food Labeling (CCFL), May 6 - 10, 2002 in Halifax, Nova Scotia. Major issues discussed included traceability, labeling of products derived from biotechnology, country of origin labeling and quantitative ingredient declaration. The Committee accepted a paper developed by the U.S. delegation on misleading claims.
Assisted WHO and FAO in planning and funding the Global Forum for Food Safety Regulators, January 28 - 30, in Marrakesh, Morocco. FDA also attended the meeting, volunteered the services of personnel to work in Geneva on the preparation of papers for the meeting, and donated monies to support travel for developing country participation in the meeting.
The following 18 items emerged as high priority after publication of the FY 2002 Program Priorities document. These are all targeted for completion in FY 2002. Some are already completed, as noted on the previous list and marked here with a double asterisk.
In conjunction with the Office of Regulatory Affairs (ORA), work with CDC to develop for foods a Laboratory Response Network to identify laboratory capacity/surge capacity for testing food for the most common agents that may be used to deliberately contaminate food.
Identify research that is needed to ensure the security of the food supply, with particular focus on developing laboratory methods for use on a food matrix.
In conjunction with ORA, increase the number of physical examinations by 97% to 24,000 and conduct sample analyses on products with suspect histories.
Implement the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188), signed by President Bush on June 12, 2002:
Provide training to FDA staff on the new legislation.
Develop an implementation plan for each provision in the new legislation.
Issue letter to stakeholders explaining the scope of legislation and strategy for implementation.
Initiate outreach to stakeholders to gather data on implementation of the legislation.
Internal activities: (1) Provide training to all CFSAN staff on general national security issues pertaining to people, information and facilities;** and (2) Construct and equip a secure "situation room" to discuss and communicate national security information.
Note: These items supplement the Food Security section of the original FY 2002 Program Priorities document.
Methylmercury: Convene the Food Advisory Committee to consider, in light of all relevant information, FDA's consumer advisory on fish consumption.
In response to P.L. 107-76, The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2002, notify stakeholders about the labeling of catfish.**
Gather additional exposure assessment data on Listeria.**
Issue "channels of trade" policy for industry for commodities with vinclozolin residues.**
Acrylamide: Develop an analytical method to measure acrylamide levels in food; initiate evaluation of acrylamide formation during cooking and an assessment of the risk; and participate in the World Health Organization's special consultation on acrylamide.
Chloramphenicol: Collect and analyze samples of honey, shrimp and crayfish for the presence of chloramphenicol, and refine the analytical method to detect chloramphenicol residues.
Develop information for consumers on dietary supplements and how to make informed decisions about use of dietary supplement products.**
Relocate office-based staff in the Office of Cosmetics and Colors to interim quarters at Vermont Avenue in Washington, D.C.
Relocate the Color Certification Staff to an interim facility in Chantilly, Virginia.
Develop a Strategic Plan for the Office of Applied Research and Safety Assessment and present it to the FDA Science Board.**
Evaluate the CFSAN regulations development SOP's in order to make additional refinements to promote quality and efficiency in all stages of the regulations development process and improve coordination with the Office of the Chief Counsel.
Provide training for CFSAN employees on the revised SOP's for developing regulations.
Develop a strategy to implement relevant provisions of the Farm Bill.
Due to the need to add additional work to the "A" List, the following 7 goals are moved to the "B*" List for the reminder of FY 2002. This means FDA will continue to work on them as time permits, but final action is not expected until FY 2003.
In conjunction with ORA, develop and conduct training of field investigators in juice HACCP inspections. [Scheduled for October, 2002]
Develop a strategy for ensuring that dietary supplement ingredients, when added to conventional foods, are lawful.
Provide general guidance for all types of submissions in electronic format and provide appropriate training to submitters.
Publish proposal on the sodium provisions for the implied nutrient content claim "healthy."
Continue to develop mechanisms to enhance timely clinical assessment of dietary supplement adverse event investigations.
Issue "Regulatory Guidebook" for industry.
Publish update for common or usual botanical names used in dietary supplement labeling as provided for in current rule.
Publish a final rule on the marking of refused food shipments. [This goal is being deleted from the "A" list because as currently written, it is not entirely consistent with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188), Enacted June 12, 2002.]
Work with the Juice HACCP Alliance to develop a core training curriculum for both FDA and industry.
Conduct a survey to identify and characterize the sources of caffeine in the food supply.