Dear Colleague, FDA Foods Community:
As promised, I am pleased to provide you with an end-of-the-year "Report Card" on the FY 2002 program priority accomplishments for FDA's foods program. These are the "boulders" we pledged to move up and over the mountaintop this year. As you will see, we completed 95% of our "A" list goals (112 out of 118 activities). I am very proud of this wonderful success rate. These results reflect a clear management strategy to focus our resources on where we provide the most benefit to American consumers.
There are five areas I would like to highlight for you.
First, you will see a major focus on activities aimed at increasing the security our nation's food supply. For example: hiring of over 600 new food safety investigators and laboratory personnel in the field; participation in emergency response exercises; preparation of extensive threat assessments; publication of food security guidance for industry; initiation of a nationwide Laboratory Response Network for foods; and conducting outreach to stakeholders prior to development of new regulations that are required by the new Bioterrorism legislation.
Second, I am pleased to report that FDA met -- and even exceeded -- all three major goals for our field activities: we conducted more than 34,000 physical import examinations (goal was 24,000); conducted more than 6,700 domestic inspections of firms that process "high risk" foods (goal was 6,650); and collected and analyzed 10,700 food samples to monitor for pesticides and environmental contaminants (goal was 8,000). This reflects the increased funding recently provided by the Congress.
Third, you will see continued emphasis and progress in all of our program areas -- food safety, food additives, nutrition and food labeling, dietary supplements, and cosmetics. This is particularly gratifying since so much of our time was re-directed to food security activities and unexpected issues such as products containing acrylamide and chloramphenicol.
Fourth, I draw your attention to the leadership role CFSAN plays in the international arena by providing the U.S. delegate to several major Codex committees, ad hoc task forces and related drafting and working groups. Progress made in the Codex Ad Hoc Task Force on Biotechnology was particularly noteworthy.
Finally, we completed the move of over 600 headquarters employees to the new Harvey W. Wiley building in College Park, MD. This is a beautiful new facility that will serve us well for many years to come. We also completed an interim move of certain office-based staff to Vermont Avenue in Washington, D.C. Looking to the future, we signed a lease to have a new, smaller building constructed nearby in College Park to house employees from our Office of Food Additive Safety and our Office of Cosmetics and Colors who could not be accommodated in the Wiley Building.
In closing, I would like to reiterate my continued appreciation for the support I have received from our many stakeholders on this management approach. I look forward to continuing this tradition of building predictability, transparency, and accountability into FDA's foods program. The American public deserves no less.
| Sincerely,
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CFSAN 2002 Program Priorities Report Card |
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Highlights: 2002 Program Priority Accomplishments |
| Part 1. Assuring Food Safety and Security |
Identified short, medium and long-term activities to minimize terrorist threats and maintain consumer confidence in the safety of the food supply. Identified activities in three categories -- anticipate, respond and deter.
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.
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 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.
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).
In conjunction with the Office of Regulatory Affairs (ORA), worked with CDC, USDA and the States to initiate development of a nationwide Laboratory Response Network to identify laboratory capacity/surge capacity for testing food for agents that may be used to deliberately contaminate food.
Redirected 15% of CFSAN' s intramural research program to address food security concerns, with particular focus on developing laboratory methods for use on a food matrix. Developed interim methods for the rapid detection of 4 priority non-traditional microorganisms and 14 non-traditional chemical agents in food, and initiated the validation of those methods in priority foods. In addition, acquired hand-held rapid test kits for 18 select agents and initiated validation studies of the kits in priority foods.
Through the Office of Regulatory Affairs (ORA), increased the number of physical import examinations by 144% to 34,445 and conducted sample analyses on products with suspect histories. This exceeded FDA's goal to increase the number of physical exams by 97% to 24,000.
Provided training to FDA staff on the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188), signed by President Bush on June 12, 2002 new legislation. A copy of the legislation is available at www.fda.gov/oc/bioterrorism/bioact.html.
Developed an internal implementation plan for each provision in the new Bioterrorism legislation. Eight areas are identified for implementation: (1) New regulations; (2) guidance to industry; (3) administrative action; (4) guidance to the field; (5) outreach to stakeholders; (6) systems development; (7) training and technical assistance; and (8) research and implementation of the select agent provision.
On July 17, 2002, issued a letter to stakeholders explaining the new regulatory requirements and FDA's timeline for implementation. A copy of the letter is available at www.cfsan.fda.gov/~dms/sec-ltr.html.
In conjunction with FDA's Office of External Relations, held six outreach meetings for stakeholders to explain the new legislation and gather data on implementation of the legislation. Additional information on outreach to stakeholders is available at www.fda.gov/oc/bioterrorism/bioact.html. Interested persons should check this web site on a regular basis as it will be updated with information concerning future public meetings on implementation of the new law.
Developed concept papers (internal) for four new regulations that are required by the Bioterrorism legislation: (1) Registration of food facilities; (2) establishment and maintenance of records; (3) prior notice of imported food shipments; and (4) administrative detention. Public dockets have been established for these four regulations. The docket numbers and instructions for submitting and/or reviewing comments are identified in the July 17th stakeholder letter referenced above.
Enhanced coordination and communication with other Federal, state and local organizations in addressing food security issues through regular conference calls and periodic meetings, and through establishment of the Food Threat Preparedness Network (PrepNet), an interagency working group co-chaired by HHS/FDA and USDA/FSIS.
Completed training sessions for all CFSAN employees on general national security issues pertaining to people, information and facilities.
Constructed and equipped in the Wiley Building in College Park, MD a "secure room" to discuss and communicate national security information.
Conducted 6,784 domestic inspections of firms that produce "high risk" foods (through ORA and the states, under FDA auspices). This exceeded FDA's goal to annually inspect 95% (6,650) of the "high risk" domestic food establishments.
Completed 261 audits of state food contracts, and continued to implement the three-year strategy to enhance FDA audit and evaluation of State inspection programs. In addition to the 32 auditors that were trained last year, sixty-five more auditors were trained in two additional courses conducted in FY 2002 -- one held January 29- 31 and the second March 12- 14.
Published guidance on the criteria FDA will use to evaluate and recommend to U.S. Customs the seizure and destruction of imported human and animal foods that pose a significant risk to public health that have not been successfully reconditioned (67 FR 67410; November 5, 2002).
Through ORA, conducted 167 inspections of foreign food establishments, with top priority to "high risk" foods. This met FDA's goal to conduct 160 - 180 foreign food establishment inspections.
Completed an evaluation of FDA's Seafood HACCP program performance for fiscal years 2000 and 2001. This is the second such evaluation. The report demonstrates steady progress by the seafood processing industry in implementing the full range of preventive controls that became mandatory in December 1997. Based on FDA's historical classifications, in FY2001 approximately 85% of firms could be considered to be "in compliance." A copy of this evaluation is available at www.cfsan.fda.gov/~dms/sec-ltr.html.
Continued to work with the Interstate Shellfish Sanitation Conference (ISSC) to implement a control strategy for Vibrio vulnificus in raw oysters that was developed in July 2001. Accomplishments this year include: (1) A substantial increase in post-harvest treatment capacity; (2) development of V. vulnificus management plans by all four source states associated with V. vulnificus illness; (3) initiation of research on the effectiveness of on-board or dockside refrigeration at reducing V. vulnificus levels in oysters; (4) initiation of research to study the effects of ultra high pressure processing on the reduction of V. vulnificus levels in oysters; (5) adoption of an interim protocol for the validation of post-harvest treatment processes; (6) development of V. vulnificus educational materials for at-risk consumers, healthcare providers and the media; and (7) initiation of a contract with the State of California to develop an education campaign for the Hispanic community on the risks of consuming raw oysters (see #53, below).
Responded to citizen petition 98P-0504 requesting that FDA establish a performance standard for Vibrio vulnificus. After reviewing the petition and the comments filed in response to FDA's notice of the petition, FDA concluded that, in lieu of establishing a performance standard, the best course of action is to continue work with the ISSC, as noted above, on implementation of the control strategy adopted last year.
Drafted a Report to Congress on FDA activities to assure the safety and quality of shellfish. The report is currently going through Administration clearance.
Drafted a Report to Congress on how FDA has implemented recommendations by GAO for bringing seafood processors into compliance with HACCP. The report is currently going through Administration clearance.
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.]
On July 23 - 25, convened the Food Advisory Committee to consider, in light of all relevant information, FDA's consumer advisory on consumption of fish that contain high levels of methylmercury. For FY 2003, FDA is making it a priority to develop an action plan based on the committee' s recommendations.
Issued a new compliance program to the field to inspect 300 juice processors for compliance with the juice HACCP final regulations. The inspections, which will be conducted in FY 2003, will cover the largest firms first (i.e., those with 500 or more employees).
Published draft guidance entitled, "Guidance for Industry: Juice HACCP Hazards and Controls Guidance" (67 FR 57820; September 12, 2002). The draft guidance will help processors and importers of juice products identify the likelihood that a food safety hazard may occur, and guide processors in the preparation of appropriate HACCP plans. A copy of the guidance is available at www.cfsan.fda.gov/~dms/juicgui3.html.
Published draft guidance for industry outlining a standardized training curriculum for application of HACCP principles to juice processing (67 FR 62489; October 7, 2002). A copy of the draft curriculum is available at www.cfsan.fda.gov/~dms/juicgui5.html. FDA also issued guidance for juice HACCP regulator training. This document outlines the conduct of inspections of juice processing firms operating under HACCP. A copy of the guidance is available at www.cfsan.fda.gov/~comm/juiceman.html.
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.
Published final juice HACCP 5-log reduction guidance (67 FR 62490; October 7, 2002). A copy of the final guidance is available at www.cfsan.fda.gov/~dms/juicgui6.html.
Published draft guidance for industry on the bulk transport of juice concentrates and certain shelf stable juices (67 FR 62488; October 7, 2002). A copy of the draft guidance is available at www.cfsan.fda.gov/~dms/juicgui4.html.
Conducted an education campaign for the egg labeling and refrigeration final rule by developing and printing 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. The materials were distributed in a direct mailing to 70,300 restaurants throughout the U.S., via FDA Regional Food Specialists and Public Affairs Specialists, and at professional meetings and conferences. In addition, 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.
Worked with states to implement egg label and refrigeration rule. More than 128,000 posters and 130,000 brochures were distributed to State Egg Program Directors and State Food Service Program Directors. In addition, as noted below (#42), the 2001 Food Code was published with language correlating to the egg labeling and refrigeration final rule.
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. This exceeded FDA's goal of achieving Food Code adoption in 28 states.
Worked with the States in an effort to address how to effectively control imports from countries that are not known to comply with FDA-endorsed, voluntary standards under the Agency' s cooperative programs. Through these discussions, FDA came to a better understanding of the obstacles facing the States and FDA as well as the viewpoint of various national organizations. FDA will continue to work on this issue.
Published the 2001 revision of the Food Code. A few significant chaulatnges 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 popions 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 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).
Acrylamide: (1) Developed an analytical method to measure acrylamide levels in food (www.cfsan.fda.gov/~dms/acrylami.html); (2) initiated an evaluation of acrylamide formation during cooking and an assessment of the risk; (3) participated in the World Health Organization' s special consultation on acrylamide (www.who.int/fsf/Documents/Acrylamide_report.pdf); (4) published a draft Action Plan for acrylamide in food (www.cfsan.fda.gov/~dms/acryplan.html); (5) initiated testing of a broad array of foods for acrylamide; (6) on September 24, 2002, convened a meeting of Government experts to foster coordination of research efforts on acrylamide; and (7) on September 30, 2002, convened a public meeting to present the draft Action Plan on acrylamide in the U.S. food supply.
Chloramphenicol: (1) Collected and analyzed samples of shrimp and crayfish for the presence of chloramphenicol ( www.cfsan.fda.gov/~lrd/fpshrimp.html); (2) met with Chinese officials to discuss concerns regarding contaminated honey imported from China; (3) issued an import alert to restrict entry into the United States of chloramphenicol-contaminated honey; (4) refined the method to detect chloramphenicol levels in shrimp and crayfish from 5 parts per billion (ppb) to 1 ppb; and (5) in conjunction Customs, uncovered a dumping scheme involving contaminated honey imports from China ( www.fda.gov/bbs/topics/NEWS/2002/NEW00831.html ).
Collected and analyzed 10,700 food samples to monitor for pesticides and environmental contaminants. This exceeded FDA's goal to collect and analyze 8,000 samples.
Participated in more than 20 industry, consumer and regulatory conferences, both national and international, to continue consumer outreach and awareness regarding the presence of allergens in foods.
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.
Conducted over 1,800 food inspections for allergens.
Submitted a Report to Congress on FDA's plans to prevent cross-contamination of foods by undeclared allergens.
Drafted a Report to Congress on the incidence of latex allergies related to food handling, FDA's monitoring of the issue, and plans to eliminate exposure to latex from food handling if data warrant such a decision. The report is currently going through Administration clearance.
In conjunction with the Los Angeles County Environmental Health Department, initiated development of a two-year campaign to raise awareness in the Hispanic community regarding Vibrio vulnificus, and to educate the Hispanic community, and in particular Hispanic males, about the safe way to eat oysters to avoid the risk of infection with Vibrio vulnificus.
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).
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Part 2. Assuring Food Safety and Cosmetic Safety: Specific Program Areas |
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.
For the petition receipt cohort of FY 2001, completed the safety evaluation in less than 360 days for 7 out of 10 (70%) food and color additive petitions that do not qualify for expedited review. This meets our goal to complete 60 - 70% of these petitions within 360 days.
Completed actions on 9 of 17 (53%) food and color additive petitions that were more than 1 year overdue at the start of the fiscal year.
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 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 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 www.cfsan.fda.gov/~dms/opa-fcn.html.
Drafted a report to the appropriations committees of the House of Representatives and the Senate that provides an estimate of the costs of carrying out the food contact substance premarket notification program. The report is currently going through Administration clearance.
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).
Conducted training for employees in the Office of Food Additive Safety and for petitioners on the submission of food and color additive petitions in electronic format. In addition to on-site training, a live webcast was held on October 10, 2001 to inform the industry about the submission of electronic food and color additive petitions. An archived copy of the webcast is available at www.cfsan.fda.gov/~dms/opaesub.html.
Completed the review of 32 notifications for new infant formulas, all within the 90-day statutory timeframe.
Continued to meet statutory obligations for nutrient content and health claim submissions. Three health claim petitions were filed for comprehensive review during FY 2002: (1) D-tagatose and non-cariogenicity (Docket No. 02P-0177); (2) Walnuts and reduced risk of coronary heart disease (Docket No. 02P-0292); and (3) Phosphatidylserine dietary supplements and reduced risk of age-associated cognitive impairment and dementia (Docket No. 02P-0413).
Submitted a Report to Congress on the outcome of recent focus groups regarding the labeling of irradiated food products and how the results will be integrated into future rulemaking decisions.
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].
Continued to conduct enforcement activities to clarify boundaries between product categories. Numerous warning letters were issued, for example, for products represented as dietary supplements that are, in fact, regulated under the Federal Food, Drug and Cosmetic Act as new drugs. Copies of these warning letters are available at www.fda.gov/foi/warning.htm, and include products such as synthetic ephedrine, antler velvet and MaculaRx™.
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 www.cfsan.fda.gov/~dms/sds-savv.html.
Reviewed 44 notifications for new dietary ingredients. All except one were reviewed within the 75-day statutory timeframe. Of the 44 notifications reviewed, 10 were filed without comment; 3 were filed with comments; and 31 were filed with objection (3 of the 31 were not dietary supplements and the remaining 28 notifications had one or more of the following deficiencies: did not meet minimum requirements of 21 CFR 190.6; did not provide an adequate basis that the new dietary ingredient was reasonably expected to be safe; or made disease claims for the new dietary ingredient, thereby, representing it as a drug).
Submitted a Report to Congress on FY 2000 spending ($6.7M) to assess the safety of dietary Supplements.
Submitted a Report to Congress on the estimated cost to implement the Dietary Supplement Strategic Plan. This report estimated that FDA would need $40 - 65 M to fully implement DSHEA. A copy of this report is available at http://www.cfsan.fda.gov/~dms/ds-stra2.html.
Issued a Consumer Advisory and letter to health professionals on the potential risk of severe liver injury associated with the use of Kava-containing dietary supplements. Copies of both documents are available at www.cfsan.fda.gov/~dms/supplmnt.html.
Issued a field assignment to obtain comprehensive data on the levels of pesticide residues in imported bulk ginseng and ginseng dietary supplements sold in the U.S., and to take proper regulatory action against any ginseng products that are found to contain unlawful pesticides residues.
Met FDA's goal by analyzing all batches of color additives and determined certification status (i.e., certify or refuse to certify) within an average of 5 working days.
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.
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Part 3. Assuring Food Safety: Crosscutting Areas |
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.]
Continued plans to acquire additional space in College Park, MD for employees in the Office of Food Additive Safety and the Office of Cosmetics and Colors. In accordance with the terms of a lease signed on September 4, 2002, a new building will be constructed on the vacant property adjacent to the newly constructed Wiley Building within approximately two years.
Initiated decontamination of the known fixed radioactive materials in FB-8 in Washington, D.C. The building is on schedule to be fully decommissioned and returned to the General Services Administration by December 31, 2003.
Renovated MOD-1 to accommodate laboratory researchers in the Office of Science who were still located in FB-8 in Washington, D.C.
Developed and implemented a plan for laboratory emergency preparedness. The plan includes general information on communication in an emergency, including mobilization of CFSAN laboratories. It also references more detailed information on laboratory capacity, methodologies and staffing. Some information is restricted to employees with appropriate security clearance.
In response to a notice of intent to renew a cooperative agreement (67 FR 44854; July 5, 2002), awarded an application submitted by the University of Maryland to continue support of the Joint Institute for Food Safety and Applied Nutrition (JIFSAN). Additional information on JIFSAN, including a schedule of upcoming activities, is available at www.jifsan.umd.edu/.
As provided in the FY 2002 Appropriations, implemented the Cooperative Agreement with the National Center for Natural Products Research at the University of Mississippi. Work done by the National Center to identify and analyze specific components in dietary supplement ingredients, including botanical ingredients, is an essential component to FDA's research and regulatory programs directed at ensuring the safety and effectiveness of dietary supplements.
Rechartered the Food Advisory Committee to include 6 subcommittees - biotechnology; dietary supplements; food additives and ingredients; contaminants and natural toxicants; infant formula; and nutrition.
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.
Developed internal standard operating procedures for CFSAN's Centralized Adverse Event Reporting System (CAERS) and conducted an initial pilot test of the system. The pilot program tested operational features of the system in order to identify problems that need to be corrected before the system is fully operational next year. Processes are now in place for data entry, evaluations of safety and medical information, and the acquisition of follow-up data, when necessary. CAERS is expected to be fully operational later in FY 2003.
Established a system that makes adverse event reports promptly available to manufacturers, including the timely redaction of confidential information. A copy of the letter to stakeholders announcing this new procedure, and a sample notification letter, are available at www.cfsan.fda.gov/~dms/caersltr.html.
Reorganized the Office of Field Programs to consolidate core compliance/case development activities within one office. The new structure has resulted in greater clarity of employee roles and responsibilities, streamlined decision-making on cases, and improved response time to recommended regulatory actions.
Improved CFSAN-Field relations through improved overall implementation of enforcement strategies. New procedures for case management have been agreed to by program directors. These changes have established a solid foundation for the establishment of well-crafted, properly prioritized and workable enforcement strategies.
Developed a correspondence Action Plan to enhance the Center's correspondence control process to ensure the orderly, timely and coordinated response to internal and external communications. As a result of these enhancements, the backlog of more than 100 pieces of correspondence has been eliminated. The Center will continue to process correspondence in accordance with the enhancements made under the Action Plan to ensure that correspondence is responded to in a timely manner.
Evaluated the CFSAN regulations development SOP's, made additional refinements to promote quality and efficiency in all stages of the regulations development process, and improved coordination with the Office of the Chief Counsel.
Provided training to over 200 CFSAN employees on the development of regulations. Eight regulatory development courses were held in FY 2002, and each was offered twice - once in College Park and once in Washington, D.C. The courses covered the following topics: Basic rulemaking requirements; the role of guidance documents and Compliance Policy Guides; the process of developing and clearing CFSAN actions, including CFSAN's revised SOP's; the role of economic analyses in regulatory actions; writing rules in plain English; writing a legally and scientifically defensible rule; the Paper Reduction Act; and World Treaty Organization obligations.
Issued a Report to Congress on the status of FDA's review of a petition requesting the promulgation of a new standard of identify for yogurt.
Issued a Report to Congress on the current work to enforce standards of identify for cheese.
Published a final rule establishing a standard of identify for white chocolate, effective January 1, 2004 (67 FR 62171; October 4, 2002). [Note: This was on the "B*" list]
Expanded recruitment efforts by participating in ten employment fairs throughout the country and visiting numerous colleges and universities. As a result of these efforts, more than 700 applications were circulated throughout the Center. This was a substantial increase over previous years in the number of applications from persons outside the government who apply for vacancies in CFSAN. In addition, training was provided to managers to broaden their knowledge of the hiring system and appointment authorities, and a new software system was utilized (Quick Hire) to allow applicants to apply for vacancies electronically.
Continued to work with the NTEU and the Partnership Committee to fully implement the Collective Bargaining Unit Agreement. Accomplishments included successful interactions with NTEU on a number of issues including issues associated with the moves to College Park, Vermont Avenue and MOD-1, such as space assignments and furniture selection; implementation of the Student Loan Repayment Program and the Recruitment Referral Award Program; reserved and handicapped parking at the new College Park facility; realignments/ reorganizations; and awards. In addition, the CFSAN Labor Management Cooperation Council held four meetings in FY 2002 and revised and finalized its charter.
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Goals Where Substantial Progress Was Made, But Completion To Be Carried-Over in 2003 Program Priorities |
Publish proposed egg safety rule for farm and retail.
Develop and implement an allergen enforcement strategy for cross-contamination.
Publish proposed rule for dietary supplement GMP's and conduct outreach.
Publish draft guidance on labeling of AHA-containing cosmetic products.
Relocate the Color Certification Staff to an interim facility in Chantilly, Virginia. [Note: Now scheduled for November - December, 2002.]
Renovate the Beltsville Research Facility in order to accommodate laboratory personnel in the Office of Seafood and Office of Cosmetics and Colors that are still located in FB-8 in Washington, D.C. [Note: Renovations are scheduled to be completed in November, 2002.]