| Note: Click on chart to enlarge |
|
Dear Colleague, FDA Foods Community:
As promised, I am providing to you a "fall progress report" from FDA's Center for Food Safety and Applied Nutrition (CFSAN) covering our 1999 program priorities. These priorities have served as the Center's workplan for the year and were outlined in a document I previously sent to you dated January, 1999 ("Yellow Book"). In a letter dated July 2, 1999, I provided you with our first update that included CFSAN's "A" list accomplishments through July 1st.
This second progress report provides the Center's accomplishments from July 1, 1999 through September 30, 1999. I am pleased to report that we have now fully completed a total of 43 "A" list program priority goals (Enclosure 1). This is a significant jump from the 14 fully completed "A" list items identified in my July 2, 1999 letter. As you can see, we track progress both by program area (Enclosure 2) as well as by responsible office (Enclosure 3) as a way of ensuring accountability. A more detailed summary of these accomplishments may be found on our web page at http://www.cfsan.fda.gov.
We have recently completed another 4-month review. Based on this review, we have added two "A" list goals: strengthening food import surveillance at the border, as directed by President Clinton in early July; and the hosting of 3 public meetings in November-December (announced last week) on foods produced through biotechnology.
I am greatly encouraged by the progress we've made to date. Projecting ahead, I believe we are on track for completing the vast majority of priority "A List" goals for this calendar year. A small number will likely be carried over into next year, primarily rulemaking activities that will be in the final review and clearance stage.
I look forward to reporting to you on our final accomplishments in January 2000. I want to thank so many of you who have supported this process and who have submitted many thoughtful suggestions for the year 2000.
|
Sincerely,
Joseph A. Levitt |
CFSAN 1999 Program Priorities Food Safety Initiative
Program Goals Accomplished
[July 1, 1999 through September 30, 1999]
Imports: Enhance follow-up and containment of foodborne disease outbreaks associated with imported food; increase surveillance of imported food overseas and at the border.
CFSAN and ORA have developed and implemented the publication; "Guide to Traceback of Fresh Fruits and Vegetables Implicated in Epidemiological Investigations." In conjunction with the publication of this document, three satellite training courses for FDA and State/Local investigators e.g., Food Microbiology (3-day), Foodborne Disease Epidemiology (3-days), Tracebacks (2-days) have been conducted. An extensive "Farm Investigation Questionnaire" for use on farms implicated in produce tracebacks also has been developed.
Finally, CFSAN and ORA conducted 19 traceback investigations involving FDA regulated products and visited 10 farms as the result of outbreak tracebacks or positive samples in the Imported Produce Sampling Program.
Initiate education/outreach and technical assistance to foreign countries on the use of Good Agricultural Practices (GAP)/Good Manufacturing Practices (GMP) guidance for produce.
A new tool to help explain the Produce Safety Initiative was completed: "Assuring Safer Produce: A Global Issue," a six-minute video that provides an overview of the good agricultural and good manufacturing practices, is available in English, Spanish, French and Portuguese.
CFSAN/JIFSAN held international conference, "Enhancing the Safety of Fresh Produce at the Source: Training Modalities and Methods, Needs and Opportunities". This landmark workshop was attended by 175 participants from 24 countries. The workshop began the process for determining how to develop an education and outreach program for growers and producers that will benefit public health and the market place.
FDA held two international meetings for government officials and food producers with food safety responsibilities. The first, targeted to countries of North and Central America, was held in Mexico City; and the second, targeted to countries of South America, was held in Santiago, Chile.
Evaluate food regulatory systems in foreign countries
CFSAN, ORA, and other FDA staff conducted an assessment of the food safety systems in Nicaragua, Costa Rica, El Salvador, Guatemala and Honduras.
Conduct 75-100 foreign inspections of food establishments
FDA (CFSAN & ORA) completed 82 foreign inspections in FY1999 of food plants (78) and farms (4) that produce food products at high risk of microbial contamination. Of these inspections: 26 Establishment Inspection Reports (EIRs) have been reviewed; 8 establishments were placed on DWPE (Detention Without Physical Examination) because of unsanitary conditions; 4 establishments were issued warning letters. Fourteen establishments were in compliance with FDA regu lations.
Good Agricultural Practices
In conjunction with USDA, CFSAN disseminated and promoted the use of the Good Agricultural Practices/Good Manufacturing Practices guidance document to both domestic and foreign agriculture communities.
Vibrio vulnificus
CFSAN published a Federal Register notice soliciting comments on citizen petition 98P-054 requesting that FDA establish a performance standard for Vibrio vulnificus.
Foodborne Outbreak Response Coordinating Group (FORCG)
Under FORCG, HHS and USDA are in the process of refining, with States, the uniform procedures developed for all agencies to follow in coordinating outbreak investigations. In regards to this effort, CFSAN, in conjunction with the field, USDA, AFDO and others, has developed a document entitled: "Foodborne Outbreak Response and Coordination." This document is intended to guide Federal agencies, State or local health officials, and State food regulatory officials involved in food or waterborne outbreaks on procedures for coordinating responses to a multi-state outbreak of food or
waterborne illness.
Outbreak Response
A document describing the decision-making criteria for handling outbreaks has been developed. This document will help CFSAN, in conjunction with the field, follow-up and contain foodborne disease outbreaks associated with domestic food.
Listeria
A questionnaire has been developed to conduct, through CDC and the FoodNet sites, a case-control study of Listeria infections to guide control efforts.
Food Safety Initiative Research and Risk Assessment
CFSAN conducted food safety research as outlined in the Center's "Three-Year Plan for Research in support of the National Food Safety Initiative and the Produce and Imported Food Safety Initiative." In addition, a review of the research projects and a plan update is complete.
Extramural Research
Second year funding for the multi-year grants awarded in fiscal year 1998 is complete. Project officers for each of the grants completed the extramural project reviews to obtain a status and update for the project.
Shell Eggs Education Campaign
A specialized "egg safety" campaign was developed in an effort to reduce the incidence of foodborne illnesses caused by Salmonella Enteritidis. Two easily reproduced fact sheets were developed--"Playing it Safe with Eggs" for consumers and "Assuring the Safety of Eggs" for food service personnel. A news article was written in English and Spanish and distributed to small dailies, weeklies and local advertisement-type publications.
Food Safety Education Month
Premarket Review of Food Ingredients
The President's Council on Food Safety issued a proclamation declaring September 1999, National Food Safety Education Month. This is an opportunity to promote food safety to consumers and the food industry. This year's theme was "Cook It Safely". FDA, in conjunction with USDA, developed and mailed consumer education planning guides to public health departments, FDA public affairs specialists and USDA extension agents throughout the country. The guide contained reproducible activities and publicity ideas for food safety education during September.
In addition, special mailings were sent to over 100,000 food service directors for at-risk audiences, school food service directors, day care directors and nursing home food service directors with special information about food safety.
Food Quality Protection Act
On July 27, 1999, CFSAN announced the availability of a guidance document entitled "Antimicrobial Food Additives -- Guidance." This document is intended to clarify FDA's jurisdiction over antimicrobials that are used in or on food, including those used in or on edible food, in water that contacts edible food, and those used in the manufacture of, or in or on, food-contact articles, subsequent to the enactment of the Food Quality Protection Act of 1996 (FQPA), and the Antimicrobial Regulation Technical Corrections Act of 1998 (ARTC A).
Nutrition, Health Claims and Labeling
Surimi Publish final rule responding to Citizen petition 98P-0968
CFSAN published a final rule to amend its ingredient labeling regulation to permit the use of "and/or" labeling for the various fish species used in the production of processed seafood products, i.e., surimi and surimi-containing foods. This rule will permit manufacturers of surimi and surimi-containing products to maintain a single label inventory identifying all of the fish species that may be used in the manufacture of the surimi product.
This action responds to petition 98P-0968 submitted by the National Fisheries Institute (NFI) requesting more flexible ingredient labeling for the fish ingredients used in the production of surimi products.
Chemical and other Contaminants
Total Diet Study Workshop
An international workshop was convened in Kansas City, Missouri from July 25 through August 6, 1999, under the auspices of FDA (CFSAN & ORA) and the World Health Organization (WHO). The focus of the workshop was to discuss all aspects of total diet studies (TDS) with those countries which have TDS and to assist those countries which don't have TDS, particularly with developing countries in their efforts to establish dietary monitoring systems for contaminants, pesticides, and nutritional elements in their food supplies.
Cosmetics
Alpha Hydroxy Acids
FDA completed a clinical study of the affects of AHAs on human skin that will help to support agency decisions concerning possible public health risks. FDA also worked collaboratively with the NCTR and NTP in the development of a state-of-the-art phototoxicity testing facility and photocarcinogenicity testing protocol for studying the long-term effects of AHAs on the adverse effects of sunlight.
Science Base
Joint Institute for Food Safety and Applied Nutrition (JIFSAN)
On July 26, 1999, CFSAN published a Federal Register notice indicating FDA’s intent to supplement the original cooperative agreement award. The intent of the notice was two fold; 1) to incorporate the cosmetics program and to include dietary supplements and food labeling under the broad program area of applied nutrition, and (2) to permit supplementation of the cooperative agreement beyond the Agency limitation of 25%. Supplemental funding was awarded on 9/30/99.
On September 27, 1999, CFSAN completed its descriptions of the JIFSAN program management structure and coordination activities within FDA.
National Center for Food Safety and Technology (Moffett Center)
A cooperative agreement with the National Center for Food Safety and Technology (Moffett Center) has been renewed for five additional years.
Peer Review: In consultation with FDA’s Office of Science, conduct an external review of the Center’s research program and its administration.
The subcommittee of the FDA Science Board has reviewed the Center’s non-FSI research program. The subcommittee’s peer review report is expected to be presented to the FDA Science Board at its next meeting.
Scientific Expertise across CFSAN Regulatory Programs
Federal-State-Local
A report titled "Preliminary Training Plan" has been prepared to identify and address training needs of regulatory scientists to strengthen and thereby, enhance the Center’s total science base. This preliminary plan is intended to apply to the needs of all Center scientists, including those involved with regulatory programs, laboratory or other research, administration and management. In addition to training activities planned by components within CFSAN, the report includes activities that are developed by and conducted through the Center's consortia,
the Joint Institute for Food Safety and Applied Technology and the National Center for Food Safety and Technology.
The National Food Safety System Project (NFSS)
NFSS has been gathering informed ideas from state and local officials as part of a collaborative process on how federal, state and local government food safety agencies could work more effectively together. Examples of NFSS Work groups contributing to agency near-term projects include:
Human Resources
All ongoing activities that support our internal environment under human resources management also have been completed. Our Human Resource goals for 1999 fall under the following four categories:
Communications
Training
Quality Environment
Future Skill Needs
Enterprise Administrative System Environment (EASE) Implementation
|
1999 Priority Goals Status Report Through September 30, 1999
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Note: Click on chart to enlarge |
|
|
| Note: Click on chart to enlarge |
|
CFSAN’s 1999 Program Priorities