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July 2, 2003
Dear Colleague, FDA Foods Community
I am pleased to report to you on the progress we are making towards implementing CFSAN's 2003 Program Priorities -- the Center's priority workplan for this fiscal year, October 1, 2002 -- September 30, 2003.
This year's plan is our most ambitious yet, with a total of 145 "A-list" goals, and through June 30, we have fully completed 59 of these priorities. These accomplishments are listed in Enclosure 1 of this document.
First, some highlights: as promised, we have published and conducted extensive outreach on four proposed regulations to implement the foods-related provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. I am pleased to report that we are on track to meet the required statutory timeframes for finalizing these new regulations. Other notable accomplishments include the publication of four guidance documents on food safety and security; implementing Operation Liberty Shield; and participating in the recent nationwide "TOPOFF2" exercise.
In December 2002, FDA announced a major initiative to enhance our Nutrition Program, entitled the "Consumer Health Information for Better Nutrition" Initiative. FDA Deputy Commissioner, Dr. Lester Crawford and I have served as chair and vice chair, respectively, of an interagency task force to develop recommendations to implement this initiative. Specific details on the Task Force will be announced separately in the very near future.
We also continue to make significant progress on a broad range of goals under all of our program areas. I am particularly pleased with the publication of the proposed rule for good manufacturing practices for dietary supplements. I also call your attention to the substantial international leadership role that our Center's scientists have played in Codex and other major global activities.
Second, I want to inform you about modifications we have made to our 2003 workplan. As a result of new priorities, we have added 10 activities to the "A" List. Enclosure 2 identifies these additions.
To ensure that we have time for these new priorities, Enclosure 2 identifies 7 "A-list" goals that have been moved to the "B" list, so that final action should not be expected this year. We therefore now have a total of 148 "A-list" goals to complete before the end of this fiscal year. Enclosure 2 also includes four goals that we have revised to accurately reflect our desired outcome.
Our overall goal continues to be to complete at least 90% of the "A" List items by the end of the fiscal year, September 30, 2003. The precise timing of Federal Register publications and completion of goals including other agencies are difficult to predict; accordingly, any such items not completedby September 30th will be carried over to next year's workplan.
Third, I ask for your input as we begin to establish program priorities for fiscal year 2004 (October 1, 2003 - September 30, 2004). A notice soliciting comments on next year's workplan was published in the Federal Register on June 5, 2002 (67 FR 33727). Comments will be accepted though August 5, 2003, and should be sent to Docket Number 98N-0359 at the Dockets Management Branch (HFA-305), 5630 Fishers Lane, Rockville, MD 20852.
In closing, I believe we are making excellent progress on our 2003 program priorities. 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.
I thank all of you for your continued support of FDA's foods program.
Sincerely,
Joseph A. Levitt
Director
Center for Food Safety and Applied Nutrition
On February 3, 2003, FDA and the Department of Treasury issued a joint notice of proposed rulemaking in the Federal Register to implement the registration provisions in section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). FDA also has begun initial demonstrations of its Internet-based IT system, which will accept electronic registrations. The proposed rule is a 60-day public comment period ending April 4, 2003. FDA plans to issue a final rule and have its registration system operational no later than October 10, 2003. This will allow affected facilities two months to register before the statutory deadline. A copy of the proposal can be found on our Web site at: http://www.fda.gov/oc/bioterrorism/bioact.html
On February 3, 2003, FDA and the Department of Treasury issued a joint notice of proposed rulemaking in the Federal Register (68 FR 5428) to implement the prior notice provisions in section 307 of the Bioterrorism Act. The proposed rule's 60-day public comment period ended April 4, 2003. A copy of the proposal can be found on our Web site at: http://www.fda.gov/oc/bioterrorism/bioact.html
On May 9, 2003, published a notice of proposed rulemaking in the Federal Register (68 FR 25188) to implement the establishment and maintenance of records provisions in section 306 of the Bioterrorism Act. The proposed rule's 60-day comment period ends on July 8, 2003. FDA plans to publish the final rule by the December 15, 2003 statutory deadline. A copy of the proposal can be found on our Web site at: http://www.fda.gov/oc/bioterrorism/bioact.html
On May 9, 2003, published a notice of proposed rulemaking in the Federal Register (68 FR 25242) to implement the administrative detention provisions in section 303 of the Bioterrorism Act. The proposed rule's 60-day comment period ends on July 8, 2003. FDA plans to publish the final rule by December 15, 2003. A copy of the proposal can be found on our Web site at: http://www.fda.gov/oc/bioterrorism/bioact.html
FDA hosted two public meetings via satellite downlink that were televised around the world to discuss and answer questions about the new proposed regulations developed to implement the four provisions of Title III of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
The first of the two meetings was held on January 29, 2003, during which the proposed rules implementing section 305 (Registration of Food Facilities) and section 307 (Prior Notice of Imported Food Shipments) were explained. The second meeting was held on May 7, 2003, during which the proposed rules implementing section 303 (Administrative Detention) and section 306 (Maintenance and Inspection of Records for Foods) were explained. A videotape and transcript of the meetings has been translated into French and Spanish and all three versions of the public meetings can be found at FDA's Web site at: http://www.fda.gov/oc/bioterrorism/bioact.html
Title III, subtitle A, section 302 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires FDA to submit an annual report to Congress describing progress made in counter-terrorism research. CFSAN has completed a review of its food security research efforts and provided a summary of its activities and accomplishments for FY 2003 to the Office of the Commissioner/Office of Policy, which will develop a full FDA Counterterrorism Research Report for FDA and HHS.
Completed the review of CFSAN's intramural and extramural research efforts to evaluate the applicability of rapid analytical tests for non-traditional pathogens for use with specified food matrices.
On March 21, 2003, published draft Guidance for Industry titled: Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance. This draft guidance represents the Agency's current thinking on the kinds of measures that retail food store and food service establishment operators may take to minimize the risk that food under their control; will be subject to tampering or other malicious, criminal, or terrorist actions. A copy of the draft guidance can be found at: http://www.cfsan.fda.gov/~dms/secguid5.html
On March 21, 2003, published draft Guidance for Industry titled: Cosmetics Processors and Transporters Cosmetics Security Preventive Measures Guidance. This draft guidance represents the Agency's current thinking on appropriate measures that cosmetics establishments may take to minimize the risk that cosmetics under their control will be subject to tampering or other malicious, criminal, or terrorist actions. A copy of the Guidance can be found on the FDA's website at: http://www.cfsan.fda.gov/~dms/secguid4.html
On March 21, 2003, published in the Federal Register (FR 68 13931) final guidance document related to food security entitled: Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance. This guidance is designed as an aid to operators of food establishments (for example, firms that produce, process, store, repack, re-label, distribute, or transport food or food ingredients). It identifies the kinds of preventive measures that operators may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal or terrorist actions. A copy of the final guidance document can be viewed at our Web site at: http://www.cfsan.fda.gov/~dms/secguid6.html
On March 21, 2003, published in the Federal Register (FR 68 13931) final guidance document related to food security entitled: Importers and filers: Food Security Preventive Measure Guidance. This final guidance is designed as an aid to operators of food importing establishments, storage warehouses, and filers. It identifies the kinds of preventive measures that they may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal or terrorist action. A copy of the final guidance can be found at our Web site at: http://www.cfsan.fda.gov/~dms/secguid7.html
On May 12, 2003, revised the "CFSAN Emergency Response Plan (CERP)." The CERP will enhance the coordination between CFSAN, the FDA Office of Emergency Operations (OEO), and the FDA Office of Regulatory Affairs (ORA) by defining the roles of all offices during emergency responses involving foods and other products within the purview of CFSAN.
The CFSAN Emergency "Situation Room" became operational February 28, 2003. CFSAN staff assigned to manage and operate the "Situation Room" has been selected. Required training sessions/exercises have begun to increase applicable staff's knowledge and readiness to respond to potential emergency situations associated with food and cosmetic products regulated by CFSAN/FDA.
The CFSAN "Secure Communications Room" became operational February 28, 2003. This room will serve as a work site where secure communication capability will be available to CFSAN staff.
In the event that the Wiley Building must be evacuated because of a building emergency or employee security emergency, our MOD-I Facility has been designated as the Alternate Worksite for CFSAN personnel. All specialized renovations including the cabling of the space identified at MOD-I as the CFSAN Alternate work site has been completed.
Emergency Response Exercises: FDA participated in numerous emergency response exercises including all levels of government:
TOPOFF 2 Exercise - During the week of May 12-16, 2003, FDA participated in the TOPOFF 2 terrorism exercise, a full scale, fully functional exercise intended to simulate two separate terrorist acts, as well as the ensuing response for federal, state, and local governments. TOPOFF 2 was a congressionally mandated interagency exercise on a national and international scale.
FDA/CFSAN held several internal emergency exercises with the CFSAN Leadership Team, Division Directors/Branch Chiefs and plans to hold exercises with the entire staff of CFSAN in FY 2004.
FDA held numerous internal exercises in FY 2003 - e.g., BSE and a food contamination exercise.
FDA also participated in exercises with other federal agencies - e.g., Crimson Winter with USDA (Foot and Mouth Disease).
FDA also participated with HHS in joint exercises with USDA at the Deputy Secretary level.
FEMA's Emergency Management Institute conducted a course for FDA entitled "Integrated Emergency Management" from May 20-22, 2003 at the Mount Weather Training Center in Virginia, Thirty-three FDA employees representing FDA's Office of Crisis Management, the Office of Criminal Investigations, and CFSAN participated in the 3-day emergency training course/exercise from May 20-22, 2003.
Operation Liberty Shield: On March 13, 2003, FDA/CFSAN issued an assignment, in conjunction with FDA's Office of Regulatory Affairs (FDA field), to conduct inspections, sample collections and import examinations targeted at specific commodities to reduce the risk that food would be intentionally contaminated, as part of the Federal Government-wide initiative called Operation Liberty Shield.
In our strategy to increase above the level of 85% the number of seafood processors that are in compliance with the seafood HACCP program, CFSAN:
On December 6, 2002, announced in the Federal Register (67 FR 72691) the availability of document: titled: Guidance for Industry Implementation of Section 403(t) the Federal Food, Drug and Cosmetic Act(21 U.S.C 343(t) Regarding the Use of the Term "Catfish." Section 10806 of the Farm Security and Rural Investment Act of 2002 amends the Federal Food, Drug, and Cosmetic Act (the Act) to provide that a food shall be deemed to be misbranded if it purports to be or is represented as catfish, unless it is fish classified within the family Ictaluridae. The guidance document states that, consistent with the amendments to section 403 of the Act, importers, domestic distributors, and sellers of fish in interstate commerce bearing the term "catfish," that is not classified within the family Ictaluridae, may no longer use the term "catfish" on labeling, in whole or as part of their common or usual name. This guidance relates to all fish that are distributed in interstate commerce, including imports. A copy of the document can be found on the CFSAN website at: http://www.cfsan.fda.gov/~frf/catfgui2.html
Completed all technical assistance, training, program reviews, and on-site audits of the Mexico molluscan shellfish safety program to determine whether that program now provides adequate protection to U.S. consumer so that it may resume exporting to the United States. A memorandum of understanding with the Government of Mexico for raw molluscan shellfish was signed on June 18, 2003.
On April 24, 2003, announced in the Federal Register (67 FR 62488) the availability of the Guidance for Industry titled: Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices. The purpose of the guidance is to provide industry with FDA's recommendations for appropriate control measures to use in the bulk transport of juice concentrates and certain shelf stable juices. A copy of the guidance can be found on our website at: http://www.cfsan.fda.gov/~dms/juicgui8.html
On April 4, 2003, announced in the Federal Register (68 FR 16541) the availability of the small entity compliance guide (SECG) for a final rule published in the Federal Register of January 19, 2001, entitled "Hazard Analysis and Critical Control Point (HACCP, Procedures for the Safe and Sanitary Processing and Importing of Juice.") The SECG, entitled "Juice HACCP," is intended to set forth in plain language the requirements of the final rule and to help small businesses understand the regulation. A copy of the guidance can be found on our website at: http://www.cfsan.fda.gov/~dms/juicgui7.html
On February 24-25, 2003, convened the FDA Food Advisory Committee to consider findings reported from Sweden in the Spring of 2002 on acrylamide levels in food. The committee reviewed the FDA draft Action Plan concerning acrylamide with the objective of determining risks and reducing levels of acrylamide in foods as quickly as possible.
On December 12, 2002, issued in conjunction with FDA's Office of Regulatory Affairs, a field assignment to analyze Total Diet Survey samples and other specific food samplers for acrylamide.
On March 3, 2003, published in the Federal Register (68 FR 9955) a proposed rule and direct final rule (68 FR 9873) for radionuclides quality standards for bottle water. This final rule will ensure that the minimum quality of bottled water, as affected by uranium, combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards. On June 9, 2003, published in the Federal Register (FR 68 34272) confirmation of effective date of December 8, 2003 for the direct final. This document confirms the final rule.
On May 3, 2003, completed the Association of Official Analytical Chemists (AOAC) multi-laboratory performance validation of commercially available immunochemical peanut protein test kits. This performance validation provides an interim analytical method that can be used for regulatory enforcement and to monitor for the presence of peanut proteins (allergens) in multiple food matrices.
For the petition receipt cohort of FY 2002, completed within 360 days of filing, the safety evaluation of three of the three (100%) 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.
For the petition receipt cohort of FY 2002, completed within 360 days of filing, the safety evaluation of six of the eight (75%) food and color additive petitions that do not qualify for expedited review. This meets our goal of completing at least 70% of these petitions within 360 day.
Completed the evaluation of all (3) biotechnology final consultations received in FY 2002.
Completed processing of 28 of 30 (93%) GRAS Notifications received in FY 2002 within 180 days. This exceeds our goal of completing atleast 80% of GRN's within 180-day statutory timeframe.
Completed review of all 111 Food Contact Notifications within 120-day statutory timeframe.
On December 18, 2002, published Guidance for Industry titled: "Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements." This document updates the Agency's approach to implementing the court of appeals decision in Pearson v. Shalala (Pearson) to include conventional foods and provides guidance to industry on the circumstances under which FDA will consider exercising its enforcement discretion for health claims that do not meet the "significant scientific agreement" standard of evidence.
This document also describes the process that FDA intends to use to respond to future health claim petitions. Finally, the document clarified that the Agency will use the "reasonable consumer" standard in evaluating food labeling claims. A copy of the guidance can be found on our Web site at: http://www.cfsan.fda.gov/~dms/hclmgui2.html
On January 15, 2003, the FDA Task Force on Consumer Health Information for Better Nutrition was established. The Task Force has been charged to provide recommendations to develop new procedures for the review of qualified health claims and to propose a consumer studies research agenda within6 months. On March 13, 2003, the Task Force established a public docket (03N-0069) to receive views and comments from interested stakeholders. The comment period closed May 27, 2003.
34. On February 20, 2003, published in the Federal Register (68 FR 8163) a proposed rule to amend the regulation for sodium levels for foods that use the nutrient content claim "healthy." The proposal establishes sodium levels for the definition of "healthy" that are not so restrictive as to preclude the use of the term "healthy," and not so broadly defined as to cause the term to lose its value in identifying useful products for constructing a healthful diet. The Agency based the proposed sodium requirements on the presumption they represent levels that are achievable by manufacturers, but sufficiently restrictive to provide consumers with a meaningful definition of the term "healthy" that will asses them in constructing a diet consistent with dietary guidelines.
On April 28, 2003, published in the Federal Register (68 FR 22341) a proposed rule to reopen the comment period for the proposed rule, published in the Federal Register of July 9, 1996 (61 FR 36154), revising its infant formula regulations in 21 CFR parts 106 and 107. The proposed rule would establish requirements for current good manufacturing practice (CGMP) and audits, establish requirements for quality factors, and amend its quality control procedures, notifications, and records and report requirements for infant formula. FDA is reopening the comment period to update comments and to receive any new information.
On November 18-19, 2003, convened the Infant Formula Subcommittee of the Food Advisory Committee. The meeting's purpose was to discuss the scientific issues andprinciples involved in assessing and evaluating whether a "new" infant formula supports normal physical growth infants when consumed as a sole source of nutrition. This was the second meeting of a series of advisory committee meetings to discuss the scientific issues involved in evaluating whether a new infant formula supports normal physical growth. Transcript and other specific information about this advisory committee meeting can be found on our Web site at: http://www.fda.gov/ohrms/dockets/ac/cfsan02.htm
On March 18-19, 2003, convened the Contaminants and Natural Toxicants Subcommittee of the FDA Food Advisory Committee. The purpose of the meeting was to discuss the scientific issues and principles involved in assessing and evaluating Enterobacter sakazakii contamination in powdered infant formula, risk reduction strategies based on available data, and research questions and priorities. The proceedings can be found at our Web site at: http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3939t1.htm
On March 13, 2003, published in the Federal Register (68 FR 12157) a proposed rule on Current Good Manufacturing Practice (CGMP's) in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements. The proposed rule would establish the minimum CGMP's necessary to ensure that, if a company engages in activities related to manufacturing, packaging, or holding dietary ingredients or dietary supplements, that company does so in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements.
The provisions would require manufacturers to ensure the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. A copy of the proposal is available on our Web site at: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5401.html
FDA/CFSAN held two stakeholders meeting to discuss the proposed regulations on Current Good Manufacturing Practices (GMPs) for dietary supplements and ingredients. The first meeting was held at the CFSAN Wiley Building in College Park on April 29, 2003, and the second meeting was held in Anaheim, Ca on May 6, 2003. As many as 86 stakeholders from industry, industry trade organizations, legal firms and other dietary supplement related organizations attended these meetings. A satellite broadcast on dietary supplement GMPs for stakeholders was held on May 9, 2003.
On March 25, 2003, convened the Dietary Supplement Subcommittee of the FDA Food Advisory Committee. The purpose of this meeting was to explore whether there are recognized scientific principles that would facilitate reaching a conclusion as to whether a particular substance is a "metabolite" of another substance that is a dietary ingredient within the scope of section 201(ff) (1) of the Federal Food, Drug, and Cosmetic Act (the act). Specific briefing information on this meeting can be found on our web site at: http://www.fda.gov/ohrms/dockets/ac/03/briefing/3942b1.htm
Strategy for Dietary Supplements containing Ephedra/Ephedrine: On February 28, 2003, HHS and FDA announced a series of actions designed to protect Americans from the potentially serious risks of dietary supplement products containing ephedra/ephedrine. Among these actions, FDA proposed a new warning label for all ephedra-containing dietary supplements. FDA relied heavily on the results of the RAND Corporation study. Additional information and materials about the risk of ephedra and ephedrine, including the full RAND report, can be found on FDA's Website at the following addresses: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00875.html. In seeking comments on the new warning label and other issues, FDA reopened a proposed rule entitled: "Dietary Supplements Containing Ephedrine Alkaloids." The comment period of the proposed rule has ended and comments are currently under review. Once all comments have been analyzed, the most appropriate approach to reducing the risk of using dietary supplement products containing ephedrine alkaloids will be determined.
On December 2, 2002, announced in the Federal Register (67 FR 71577) the availability of a draft guidance document entitled "Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients." This draft guidance is intended to provide the cosmetic industry with suggested wording for a label statement alerting consumers to the possibility of increased skin sensitivity, particularly sunburn, associated with the use of such products, as well as protective measures to use.
On May 16, 2003, updated and finalized an inter-center agreement between FDA's Center for Drug Evaluation and Research (CDER) and the Center for Food Safety and Applied Nutrition (CFSAN) to assist FDA in implementing the drug and cosmetic provisions of the Federal Food, Drug and Cosmetic Act for products that purport to be cosmetics but meet the statutory definition of a drug. This three-year memorandum of understanding, which took effect June 1, 2003, supersedes the pre-existing agreement, which expired May 31, 2003.
Attended, on behalf of FDA, the 25th Session of the Codex Alimentarius Commission, held February 13-15, 2003, in Geneva, Switzerland. The purpose of the Session was to discuss the Report of the Joint FAO/WHO Evaluation of the Codex Alimentarius and other FAO and WHO Work on Food Standards. The Commission agreed upon a statement on the outcome of the evaluation. This statement will be submitted to the Governing Bodies of WHO and FAO for further consideration. A copy of the report can be found at: http://www.who.int/fsf/Codex/Codex_Evaluation_Final_Report_en.pdf
Led U.S. Delegation to the 24th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses in Berlin, Germany, on November 4-8, 2002. The Committee spent a considerable amount of time discussing the Scope of two Proposed Draft Revised Standards: (1) Proposed Draft Revised Standard for Infant Formula and (2) Proposed Draft Revised Standard for Processed Cereal-Based Foods for Infants and Young Children. The Committee was able to hold only limited discussion on the Draft Guidelines on Vitamin and Mineral Food Supplements. The Delegation of Germany presented a revision to the Advisory List(s) of Mineral Salts and Vitamin Compounds for the Use in Foods for Infants and Young Children in view of the comments provided. The Committee decided to keep the Advisory List at step 2/3 for redrafting, comments and further discussion at the next session.
Led U.S. Delegation to the 11th Session of the Codex Committee on Import and Export Inspections and Certification Systems (CCFICS), December 2-6, 2002, in Adelaide, Australia. Most notably the CCFICS completed work on the Draft Guidelines on the Judgment of Equivalence of Sanitary Measures Associated with Food Import and Export Inspection and Certification Systems. The Committee also agreed to continue work on traceablilty/product tracing. Also at this 11th Session of the CCFICS, the committee continued work on the following documents: (1) Proposed Draft Guidelines for Exchange of Information in Food Control Emergency Situations: (2) Proposed Guidelines for the Judgment of Equivalence of Technical Regulations Associated with Food Import and Export Inspection and Certification Systems; and discontinued work on Proposed Draft Guidelines for the Utilization and Promotion of Quality Assurance Systems to Meet Requirements in Relation to Food.
Led U.S. Delegation to the Codex Committee on Food Hygiene (CCFH), January 27th - February 1st 2003, in Orlando, Florida. At this session, the CCFH advanced the Code of Hygienic Practice for Milk and Milk Products; approved for final adoption by Codex revisions of the Codex HACCP guidelines; approved new work to initiate revision to an old Code of Hygienic Practice for Foods for Infants and Children: this revision will take into account current concerns associated with the possible presence of Enterobacter sakazakii in Infant Formula; agreed to a revised approach to develop risk management guidance for Listeria monocytogenes and to work towards the development of risk management guidance for several other foodborne pathogens including Salmonella, Campylobacter, Vibrio parahaemolyticus and enteropathogenic E.coli; and finally, the committee initiated a process to develop a long term approach and strategy to assigning priorities for its work, developing its Codex texts, and interacting with other Codex Committees.
The 35th Session of the Codex Committee on Food Additives and Contaminants (CCFAC) was held in Arusha, United Republic of Tanzania, on March 17-21, 2003. Due to travel restriction based on world events, the U.S. Delegation participated in the development of a number of the standards and codes of practice on the agenda but did not attend the meeting, and the only delegation from the western hemisphere in attendance was Brazil. The CCFAC forwarded the following standards and codes of practice for final adoption (Step 8) by the 26th Session of the Codex Alimentarius Commission (CAC): (1) Revisions to the Annex to Table 3 of the Codex General Standard for Food Additives; (2) Revised Codex General Standard for Irradiated Foods; (3) Code of Practice for the Prevention and Reduction of Patulin Contamination in Apple Juice and Apple Juice Ingredients in other Beverages; (4) Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals, including Annexes on Ochratoxin A, Zearalenon, Fumonisns and Tricothecenes; (5) Revisions to the Codex International Numbering System (INS) for Food Additives; (6) Specifications for the Identity and Purity of Food Additives.
The 35th CCFAC also advanced the following documents for intermediate endorsement by the 26th CAC: (1) Risk Analysis Principles Applied by the Codex Committee on Food Additives and Contaminants: (2) Revised Food Category System of the Codex General Standard for Food Additives: (3) Principles for Exposure Assessment of Contaminants and Toxins in Foods: (4) Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Peanuts: (5) Code of Practice for the Prevention and Reduction of Lead Contamination in Foods: (6) Maximum Levels for Cadmium.
Served on U.S Delegation to the Codex Committee on General Principles (CCGP), April 7-11, 2003, in Paris France. At this session, the CCGP recommended for adoption at Step 8 by the Codex Alimentarius Commission Working Principles for Risk Analysis in the Framework of Codex. This "Principles" document provides overarching guidance in the form of principles on the three elements of risk analysis (risk assessment, risk management, and risk communication) to Codex Committees, particularly those dealing with food hygiene, food additives and contaminants, pesticide residues and veterinary drugs. The Committee held at Step 2 for further discussion a companion document that provides guidance to countries on risk analysis. The Committee also agreed to undertake the development of a definition for product tracing/traceability and continued work on the revision to the Codex Code of Ethics for International Trade in Food. Additionally, the Committee recommended for adoption amendments to the Codex Procedural Manual that would allow full voting membership in Codex of "Regional Economic Integration Organizations" (e.g., the European Union) and continued discussion on how Codex might interact with other international intergovernmental organizations in the development of food safety and quality standards.
Led U.S. Delegation to the Codex Committee on Food Labeling (CCFL), April 28 - May 2, 2003, Ottawa, Canada. The CCFL is charged with drafting, amending, and endorsing provisions on labeling applicable to all foods. Major topics discussed at the meeting include nutrition labeling including trans fatty acids, health claims, biotechnology, country of origin labeling and misleading claims.
Led U.S. Delegation to the Codex Committee on Fats and Oils (CCFO), February 3-7, 2003, London, United Kingdom. The Committee reached consensus on theDraft Revised Standard for Olive Oils and Olive Pomace Oils at Step7and recommended final adoption by the 26th Session of the Codex Alimentarius Commission (CAC). Although the Committee made significant progress in its discussion of the Draft Standard for Fat Spreads and Blended Spreads, time was not sufficient to complete deliberations and the draft was returned to Step 6. The U.S. delegation had prepared a proposal to amend the Standard for Named Vegetable Oils to add mid-oleic sunflower oil to the Standard. The Committee agreed to "fast track" the proposal and recommend final adoption by the 26th CAC. The last major topic discussed was the Recommended International Code of Practice for the Storage and Transport of Edible Fats and Oils in Bulk (Draft list of Acceptable Previous Cargoes).
The U.S., supported by several delegations, recommended discontinuing the elaboration of the "List" and deferring to lists developed by the relevant international organizations: National Institute of Oilseed Products, Federation of Oils, and the Seeds and Fats Association. Other delegations however, did not agree and the Committee finally decided to request the CAC to invite JECFA to develop evaluation criteria and to evaluate the substances of the Draft List that are currently at Step 3.
Led U.S. Delegation to the Codex Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology, Yokohama, Japan, March 11-14, 2003. The Task Force completed work on a draft guideline for the safety assessment of foods derived from bioengineered microorganisms and recommended that the Codex Alimentarius Commission at its next meeting in July 2003 consider the draft guideline for adoption.
Led U.S. Delegation to the Third Session of the Codex Task Force for Fruit and Vegetable Juices, May 6-10, 2003, in Salvador Brazil. The Task Force reached agreement on the principle provisions of the Codex Proposed Draft Standard for Fruit Juices and Nectars and forwarded the Standard to the Codex Alimentarius Commission for final adoption. Still pending within an Annex are specific brix (total soluble solids) values for several fruit juices, including orange juice. Final resolution of the brix value for orange juice will be difficult since major orange juice producers (the United States and Brazil) require higher brix values than other countries (e.g., the members of the European Community) that don't produce orange juice but are major importers of the product. The issue is one of significant trade economics as well as one of potential product fraud.
The outstanding brix values will be dealt with at the final Session of the Task Force, scheduled for fall, 2004. The Task Force also agreed to discontinue work on the Draft Revised Standard for Vegetable Juices since there is little international trade in this commodity. In this regard the Task Force also recommended that the current (and old) Codex standard for vegetable juices be revoked.
Led U.S. Delegation to the Seventh Session of the Codex Regional Coordinating Committee for North America and the Southwest Pacific (CCNASWP), October 29 - November 1, 2002, in Vancouver, Canada. The Committee received a status report on the WHO/FAO Evaluation of Codex; the Evaluation has since been issued, was initially discussed at a Special Session of the Codex Commission and will be further discussed at length at the upcoming 26th Session of the Commission.
The Committee also reviewed the status of the Codex Trust Fund, to be used to enhance the participation of developing countries in Codex (the Trust Fund was formally launched in February, 2003). CCNASWP extensively reviewed and commented on the Codex Medium Term Plan for 2003-2007; the Plan contains the specific work activities that Codex anticipates undertaking during the period. Additionally, the Task Force considered the work that Codex is undertaking on the subject of traceability/product tracing and developed what essentially constituted a set of principles on the use of traceability/product tracing for use by Codex; this set of principles has subsequently proved valuable in other Codex venues in which the issue of traceability/product tracing is being discussed. CCNASWP also received reports on the regular activities of WHO and FAO.
Led U.S. Delegation to the 24th Session of the Codex Committee on Methods of Analysis and Sampling, November 18-22, 2002 in Budapest, Hungary. The Committee agreed to recommend inclusion in the Codex Procedural Manual of working instructions of the selection of methods of analysis. The Committee also proposed that the Commission adopt for Codex purposes the Harmonized IUPAC Guidelines for Single-Laboratory Validation of Methods of Analysis. The Committee also: endorsed several methods of analysis appearing in Codex commodity standards; proposed for adoption several methods of analysis for food additives and contaminants; advanced in the Codex step procedure guidelines for sampling and guidelines for the measurement of uncertainty; and agreed to initiate new work on guidelines for settling disputes on analytical test results.
Human Resources Relocation to Rockville: On April 25, 2003, CFSAN's Human Resources Office (HR) relocated its offices to the current FDA Headquarters site at the Parklawn Building in Rockville, Maryland. The relocation of the CFSAN HR Staff responds to the "Strategic Management of Human Capital" goal under the President's Management Initiative of 2002. This goal requires the consolidation of all FDA personnel offices into a single HR office.
In our continued program to relocate CFSAN personnel at our MOD-I /BRF/Chantilly, VA facilities to state of the art facilities in proximity to our College Park Facility, planning continues for the adjunct buildingand the eventual relocation of personnel from Vermont Avenue and Chantilly Va. to College Park. Pending construction of our adjunct building near our existing College Park Facility, we moved our Color Certification Staff from the FB-8 site in Washington D.C. to an interim (state of the art) facility located in Chantilly VA. Also in FY 2003, we moved the remaining laboratory scientists working in both our Office of Applied Research and Safety Assessment (OARSA) and our Office of Seafood from the FB-8 site to our MOD-I and Beltsville Animal Research (BRF) facilities in Laurel, MD.
The Center for Food Safety and Applied Nutrition's (CFSAN) Outreach and Information Center (OI&C) has successfully completed its relocation to the Wiley Building at College Park in March 2003. A major component of the OI&C relocation was the installation of all phone lines and software for the new more sophisticated "Call Center." It is our hope that the enhanced voice response and call distribution capability will improve the day-to-day operations as well as our important service to the consumer.
Converted all CFSAN staff utilizing FDA/CFSAN's computerized communications network to the new "Secure Remote Access" (RSA). RSA is a new IT security software/hardware that secures data traveling between individual PC/laptops and FDA/CFSAN's network. It prevents data from being intercepted by hackers or lost or from theft of any new CFSAN supplied PC/laptops.
The following 10 new goals emerged as high priority after publication of the FY 2003 Program Priorities Document. These goals are all targeted for completion before the end of FY 2003.
"Operation Liberty Shield": Implement Operation Liberty Shield Initiative, for food products regulated by FDA, including increased surveillance of domestic and imported foods.
Training Personnel on BT Regulations: In conjunction with the Office of Regulatory Affairs (ORA), conduct training session for FDA personnel on the new regulations issued under the Bioterrorism Act.
Product-specific Guidance:As appropriate,provide Guidance to specific segments of the food industry on preventive measure that they can take to reduce the risk that their products will be subject to intentional contamination.
Develop and initiate a task order to develop preventive measures for product areas identified as high and medium food security risks.
Complete review of the Mexico molluscan shellfish safety program.
Respond effectively, working with APHIS and FSIS, to the occurrence of BSE in Canada.
Perchlorate: Initiate development of an analytical method to detect Perchlorate in produce, so that FDA can conduct effective monitoring.
Submit a Report to Congress describing FDA current regulations on intrastate and interstate requirements for Pet Turtles, in response to the FY 2003 Omnibus Appropriations Bill P.L. 108-7, enacted 2/20/03.
"Monkey Pox": In conjunction with ORA and the Centers for Disease Control and Prevention (CDC), support activities to control interstate transport of animals and high-risk animal derived products contaminated with monkey pox.
Codex Committee on Methods of Analysis and Sampling.
Due to the need to add additional work to the "A-list," we have moved the following 7 goals to the "B-list" for the remainder of FY 2003. This means FDA will continue to work on these goals as time permits, but we will not expect final action this fiscal year.
Issue for public comment, industry and field staff guidance to implement authorities under the Bioterrorism Act (P.S. 107-188) in effect as of July 2002. [1.1.10]
Upgrade two facilities, MOD-I and NCFST, to BL3 safety level. [1.2.9]
Convene a public meeting of the Food Biotechnology Subcommittee of the Food Advisory Committee to discuss current agency activities in food biotechnology. [Deferred to FY 04] [3.3.1]
Publish a proposed rule to require the declaration of carmine/cochineal extract, a color additive, on the ingredient statement of food, drug, and cosmetic products containing it. [1.13.3]
Color Additive Lakes (PRIA): Publish, for public comment, analysis of economic impact of proposed rule. [2.4.1c]
Trilateral U.S./Canada/Mexican Technical Working Group for Food Labeling, Packaging and Standards. [3.2.1-12]
Publish a draft Compliance Policy Guide (CPG) for chloropropanols. [2.1.4a]
The following goals have been revised as a result of new information after issuance of our Program Priorities Document. Please see bracketed information following each goal for an explanation for its revision.
Upgrade two facilities, MOD-I and NCFST, to BL3 safety level and implement and enhance a security plan for all CFSAN laboratories. [This goal has converted into two separate goals with the BL3 upgrades being moved to the B-list.]
Issue more limited guidance for fresh-cut produce, in conjunction with educational video produced with the California Department of Health Services. [We have deleted this goal because the California Department of Health Services has prepared and issued video on fresh-cut produce.]
In conjunction with the State of California and the ISSC, implement an education and outreach program onVibriofor Hispanic men. [Modify to read: "In conjunction with the ISSC, implement an education and outreach program on Vibrio for Hispanic men in one or more states."]
Convene meeting of the Food Advisory Subcommittee on Nutrition. [Modify to read: "Constitute a Food Advisory Subcommittee on Nutrition with the first meeting planned for FY 2004."]
