FDA's Accomplishments
–A First Year Report
October 1, 1997 - September 30, 1998
FDA's Accomplishments
–A First Year Report
October 1, 1997 - September 30, 1998
Dear Colleague,
It is with great pride that I share with you the Food and Drug Administration’s (FDA) Fiscal Year 1998 accomplishment report under the President’s Food Safety Initiative.
FY 98 was an exciting and challenging year. On every front, from the farm-to-the-table, progress was made to better understand, better prevent and better contain harmful foodborne illness.
In the report you will find accomplishments in the areas of early detection and containment of foodborne hazards; prevention, education and verification; and scientific research and risk assessment. As you read the report you will see that all of us–from FDA, the U.S. Department of Agriculture and the Centers for Disease Control and Prevention at the Federal level, to state and local government officials, to agriculture, industry and consumer representatives, to the scientific and medical community–had a part in the effort to reduce the incidence of foodborne illness. Without the involvement of everyone, progress could not be achieved.
While we are pleased with last year’s accomplishments, we know that the work has just begun. In FY 98, the foundation was set for creating a state-of-the-art food safety system and initiating seafood HACCP implementation. Now in FY 99, we are building on the that foundation to enhance follow-up and containment of foodborne disease outbreaks associated with imported food and increase surveillance of imported food overseas and at the border; promote the use of Good Agricultural Practices/Good Manufacturing Practices guidance for produce and develop a strategy to ensure the safe production of sprouts; continue to implement seafood HACCP; and develop a nationally integrated food safety system.
We will continue to keep you advised of food safety initiative activities through this year.
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Sincerely yours,
Joseph A. Levitt Director Center for Food Safety and Applied Nutrition |
Executive Summary
The President's Food Safety Initiative, including the Produce Initiative, provides the framework for meeting the challenge of reducing the incidence of foodborne illness to the greatest extent possible. The initiatives are broad-based and cover the farm-to-table continuum.
In FY 98, the foundation was set for creating a state-of-the-art science-based food safety system. This system focuses on early detection and containment of foodborne hazards, and prevention, education and verification.
Virtually all the goals promised for the first year in the May 1997 Farm-to-Table Report, (Fiscal Year 1998–October 1, 1997 to September 30 1998) were achieved. FSI programs at FDA were provided with a $24 million budget increase, with additional funding provided to the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA). Many of these activities were accomplished in conjunction with Federal and state partners.
Highlights of the year's accomplishments follow.
Early Detection and Containment of Foodborne Hazards
FY 98 saw tremendous strides in enhancing surveillance of food disease, building an early warning system, enhancing responses to foodborne outbreaks and improving risk assessment. The impact of these efforts is the development of preventive control and containment systems and new technologies to stop microbial contamination.
Prevention, Education and Verification
Activities to improve in inspections and compliance, ensure the safety of imported and domestic produce and further the role of food safety education for producers, retailers, public health officials and consumers were undertaken in FY 98. These activities will result in a safer food supply by stemming the reoccurrence of foodborne illness situations from farm to table.
Science-based Underpinning to Food Safety System
In FY 98, food safety research results were announced, new research and risk assessment grants were awarded, and procedures were established to better plan and coordinate research among federal partners. The necessity of the scientific progress is clear as new pathogens in food and animal feed will continue to need to be identified and new methods to replace the time-tested controls for controlling pathogens, such as heat and refrigeration, will need to be developed.
On January 25, 1997, the President announced a Food Safety Initiative to reduce the incidence of foodborne illness to the greatest extent possible. Four months later, recommendations were delivered to the President outlining the steps the federal government would take in the short and long-term to achieve that goal. Following on the heels of the Food Safety Initiative, the Produce Initiative was announced by President Clinton on October 2, 1997 to ensure the safety of imported and domestic fruits and vegetables.
The initiatives are broad-based and cover the farm-to-table continuum. They are based on the public-health principles that the public and private sectors should identify and take preventive measures to reduce the risk of illness, should focus efforts on hazards that present the greatest risk, and should make the best use of public and private resources. Increasing collaboration between public and private organizations and improving coordination within the government as work progresses toward the common goal of improving the safety of the nation's food supply are central to farm-to-table food safety initiative.
Conceptually, improving the safety of the food supply requires three main components: First, there must be in place a state-of-the art system for early detection and containment of foodborne hazards. This includes timely identification and reporting of foodborne illnesses, appropriate monitoring of the food supply for hazards, and rapid detection and control of illness outbreaks. Equally important, however, is a food safety system that is based on prevention, education and verification. Finally, the food safety system must be science-based.
In Fiscal Year 1998 (October 1, 1997 to September 30, 1998) virtually all of the goals committed to in the report to the President, May 1997, for the first year were achieved. FSI programs were budgeted at $43 million for food-safety work at the Food and Drug Administration (FDA), the U.S. Department of Agriculture and the Centers for Disease Control and Prevention (CDC).
Described in the following pages are some of the major accomplishments achieved in FY 98.
Enhance Surveillance and Build an Early Warning System
1. Disease Surveillance Increased – Surveillance for foodborne disease has increased significantly during FSI's first year with the expansion of FoodNet, an active surveillance program for foodborne disease operated collaboratively by CDC, FDA, USDA and five state health departments. With NFSI support, two more sites–the Rochester-Albany area of New York State and the greater Baltimore, Maryland area were added to FoodNet in FY 98, bringing the total number of sites to seven. In addition, NFSI resources were used in states not participating in FoodNet to improve foodborne disease surveillance nationwide.
2. Pathogen Identification System Established – A major FSI accomplishment in 1998 was the establishment of PulseNet, a computerized database of bacterial DNA subtypes, which can speed identification of food products causing disease outbreaks. PulseNet is electronically networked to state laboratories, CDC, FDA and USDA. The system determines bacterial subtypes with a high degree of accuracy and transmits that information digitally to a central computer at CDC. The CDC computer can match a newly submitted pathogen fingerprint to those in the databank, and can confirm whether or not disparate outbreaks are connected by a common source.
3. National Antimicrobial Resistance Monitoring System (NARMS) Enhanced – The National Antimicrobial Resistance System (NARMS) was enhanced in FY 98 to improve FDA's ability to detect emerging resistance among foodborne pathogens and to provide better information for policy decisions. The surveillance program has expanded its scope of data by adding new partnerships and FoodNet sites to the NARMS, increasing the HACCP bacterial human and animal isolates sampled in order to improve monitoring for the transfer of antibiotic resistant bacteria to humans, and increasing new veterinary diagnostic laboratories.
4. NARMS Facilitates Recognition of Salmonella Typhimurium DT104 – FDA, CDC and USDA collaborated in response to an outbreak of salmonellosis among residents of a Vermont dairy farm. This illness was caused by Salmonella Typhimurium DT 104, a multi-resistant pathogen, on the farm and in the surrounding area. NARMS facilitated the recognition that Salmonella Typhimurium DT 104 was widespread in the U.S. which prompted CDC to warn state health department of its presence and provide preventive steps to minimize its spread.
5. Veterinary Drug Use Survey Instrument Developed "A veterinary drug use survey instrument was developed for use in a six-state poultry study in cooperation with USDA. The survey is currently being used in an Arkansas-based poultry Campylobacter study with NCTR. The study will provide information on the microbial ecology of zoonotic enteric in poultry and in the production environment using molecular genetic techniques.
6. Veterinary Drug Use Assessed – FDA assessed veterinary drug use from Doanes data as a preliminary step to conducting nationally representative surveys through the National Animal Health Monitoring Surveys conducted by USDA. Discussions were begun with USDA to merge veterinary drug prescribing and producer use surveys within the National Animal Health Monitoring Surveys for feedlot cattle and swine.
7. Microbiological and Genetic Studies Initiated –In FY 98, FDA initiated molecular and genetic studies with the National Center for Toxicological Research (NCTR) to clarify the role of transfer of antibiotic resistance genes in animals intended for food. Organisms in the gut of food animals are known to acquire and exchange genetic information, including antimicrobial resistance genes. Selection pressure in the form of antimicrobial compounds given to animals to treat disease or promote growth may result in the emergence and spread of antimicrobial resistance genes. This can increase the frequency of these genes in bacterial populations that inhabit food-producing animals. These resistant bacteria or their resistance genes may be transferred to people who consumer the animals as food and can be a significant risk to public health through limiting the effectiveness of antimicrobial therapy.
8. Annual Report on Antimicrobial Susceptibility Monitoring Program Published –Publication of the annual report, FDA/USDA/CDC National Antimicrobial Susceptibility Monitoring Program-Veterinary Isolates, April 1, 1998, has provided the animal production industry with national Salmonella susceptibility data from food animals. The publication of this report has initiated activities between producers, the American Veterinary Medical Association, veterinarians and the pharmaceutical industry. Producers are increasingly aware of the food safety issues associated with antimicrobial resistance and as a result are developing studies to identify prudent and judicious antimicrobial use practices, interventions and mitigations for extant resistance in organisms of concern, and determine other husbandry practices that reduce the need for antimicrobials in food animal production. An effective response on the part of industry will ensure that drugs necessary for the treatment of food animals will remain effective longer and that foodborne pathogens will be less likely to be resistant to antimicrobials.
9. Campylobacter Testing Begins – FDA initiated veterinary Campylobacter isolates testing, multi-resistant Salmonella strain testing, and human enterococcus pilot studies. This is necessary because Campylobacter is the most common foodborne disease and fluoroquinolone resistance is emerging in Campylobacter species which may require regulatory action.
Improve Responses to Foodborne Outbreaks
10. Intergovernmental Group Established to Coordinate and Speed Outbreak Response - The level of science being applied to foodborne disease through NFSI resources is rapidly identifying clusters of related cases and contaminated foods that would have been missed just a few years ago. While this creates tremendous opportunities to prevent exposure and protect consumers it also exposes unwieldiness in the existing systems of interagency coordination and communication. To develop a comprehensive, coordinated national foodborne illness outbreak response system among federal, state and local agencies, HHS, USDA, and EPA signed in May 1998 a memorandum of understanding to create the Foodborne Outbreak Response Coordinating Group, or FORC-G. This group's objective is to enhance coordination and communication among federal, state and local agencies, guide efficient use of resources and expertise during an outbreak, and prepare for new and emerging threats to the U.S. food supply. In addition to federal officials, other members of FORC-G include the Association of Food and Drug Officials, Association of Publlic Health Laboratory Directors, Council of State and Territorial Epidemiologists, and the National Association of State Departments of Agriculture.
11. Epidemiology Rapid Assessment Team Formed – FDA, CDC and the Council of State and Territorial Epidemiologists established a Rapid Assessment Team to provide quick review of epidemiological reports of foodborne illness. The team's experts are on call 24 hours a day to provide the most rapid possible review of incoming reports of foodborne disease.
12. Steps Toward Integrating State, Local and Federal Food Safety Efforts – In September 1998, FDA hosted an important meeting of food safety officials from all 50 states, the District of Columbia and other localities, Puerto Rico, FDA, USDA and CDC to better integrate appropriate food safety functions at the local, state and federal levels. Integration efforts are focusing on inspection, analytical methodology, laboratory utilization, and response to disease outbreaks. The goals of this integration effort are better use of laboratory resources and investigative expertise and faster response to and control of foodborne illness outbreaks.
13. Outbreak Liaison Positions Established at CDC " In the summer of 1998, CDC established a liaison at FDA's offices in Washington, paralleling the FDA liaison at CDC in Atlanta. The dual liaisons will improve coordination of activities between the two agencies when they cooperatively investigate foodborne illness outbreaks.
Improve Risk Assessment
14. Risk Assessment Consortium Role Expanded – The Risk Assessment Consortium, composed of USDA, FDA, NIH's Division of Allergy and Infectious Diseases, CDC and EPA, saw its role expanded in FY 98. The RAC, accomplished numerous interagency activities that have helped advance the science of microbial risk assessment. The following are specific accomplishments of the RAC:
15. Risk Assessment Clearinghouse Established – A Risk Assessment Clearinghouse was established by the Risk Assessment Consortium to serve as a repository for data, methods, and tools in the area of food safety risk assessment.
PREVENTION, EDUCATION AND VERIFICATION
Improve Inspections and Compliance
16. FDA Inspection and Investigation Force Expanded – In FY 98 with new FSI funds, FDA added 61 new inspectors and investigators and 19 microbiologists to its food safety regulatory force.
17. Traceback Procedures Established – FDA completed writing a set of new and comprehensive operating procedures for conducting fast, effective traceback investigations when fresh fruits and vegetables are implicated in disease outbreaks. The agency also provided training on the new procedures to its field force, which is now using them when investigating cases of foodborne disease.
18. FDA Worked with Guatemalan Producers of Raspberries " FDA worked with Guatemalan producers of raspberries to develop a Model Plan of Excellence. Previous U.S. outbreaks of foodborne illness associated with Guatemalan raspberries led to a ban on their importation into the U.S. for their 1998 spring crop. As a result of the plan, some farms will be allowed to export to the United States.
19. Seafood Hazard Control Programs Implemented –Under NFSI, FDA committed to inspecting all domestic seafood processors by the end of 1998 to verify that appropriate Hazard Analysis and Critical Control Point (HACCP) plans are in place, or, where they are not, to provide technical assistance in getting them set up. HACCP plans are written procedures prescribing safety checks and other regular steps performed by food processors and manufacturers to prevent contamination of food products. HACCP plans were required for seafood processors beginning December 1997. As of the end of FY 98, FDA and state inspectors inspected 3,600 processors, with the expectation that by the end of calendar 1998 virtually all of the 4,000 processors would be inspected.
20. HACCP Guide Published for Fish – FDA published the second edition of its "Fish and Fishery Products Hazards and Controls Guide," a compendium of advice on how to establish and operate a HACCP system for virtually all fish species and processing conditions. The changes from the first edition to the second edition were based largely on input from academia and industry and reflect FDA's interest in using this Guide as a vehicle for partnership with all HACCP stakeholders. There is no other guidance in the world that is as comprehensive as the FDA Guide. Foreign regulatory authorities are starting to use it as part of their HACCP-based inspection systems.
21. Computerized Database Established for HACCP Seafood Inspections–FDA developed a national computerized database for tracking the results of seafood HACCP inspections. The database is tailored to HACCP and can include the results of state, as well as Federal inspections. In this way, the database helps foster partnerships with states that establish equivalent HACCP-based inspection systems.
22. Warning Labels on Unpasteurized Juices – In September 1998, FDA's rule became effective requiring warning labels on packaged apple juice products that are not pasteurized or otherwise treated to kill pathogens. For all other unpasteurized or untreated juices, the rule became effective in November.
The warning label states that the product has not been pasteurized, that it could harbor harmful bacteria, and that young children, the elderly and those with compromised immune systems should not consume the product. Placards containing this warning are required at points-of-sale of unpasteurized packaged juice products from Fall 1998 until Fall 1999, if labels are not affixed to packages. By Fall 1999, all packages of unpasteurized or untreated juice products must include the warning statement on the label.
An exception to the rule covers citrus juice processors who agree to meet specific conditions toward ensuring the safety of their products, allowing them up to eight additional months to comply with the new requirements for carrying warning labels on untreated packaged fresh citrus juices. During the eight months, these processors must develop, adapt, and validate procedures that achieve a 5-log reduction in the pertinent pathogens while establishing interim protection measures using HACCP.
In November 1998, FDA held two technical workshops to provide juice manufacturers with an opportunity to share interventions and discuss strategies that have been developed for measuring and validating a 5-log reduction in citrus juice production.
23. Fresh Apple Juice and Cider Firms Inspected – In the Fall of 1997, FDA initiated an inspection and sampling program covering 250 firms producing unpasteurized apple juice and cider. Samples from production lines and finished products were analyzed for the presence of bacteria, including pathogens. The program also profiled individuals firms' food safety controls, to provide data to the agency on industry practices, and allow a comparison against various control and bacterial levels in finished products. Data from this inspection program were used to develop FDA's proposed HACCP program for juice manufacturers.
24. Hazard Control Programs for Juice Manufacturers – In April 1998, FDA proposed that juice manufacturers adopt HACCP programs in their plants. The proposal was based on the record of illnesses and injuries associated with the consumption of contaminated juice products. The agency is in the process of developing a final regulation.
25. Workshops on Cider Safety Conducted " In the summer of 1998, FDA conducted two workshops in midwest and northeast apple-growing areas to teach cider and fresh juice producers safety steps to guard their products against microbial pathogens.
26. Rulemaking Initiated to Increase Egg Safety – In May 1998, FDA and USDA published an advance notice of proposed rulemaking on egg safety. The notice signaled FDA's intention of requiring label statements on egg cartons about the risk of pathogens and the importance of proper handling and cooking. The notice also indicated FDA is considering a requirement that eggs be kept cold while being held at points of retail sale. The notice sought information and comment on these and other alternative approaches for improving egg safety. The agency expects to issue a proposed rule in the coming months.
27. Sprout Production Facilities Examined " In July 1998, a team of FDA food scientists toured scores of sprout production facilities to get a first-hand look at industry production techniques. Information gathered will inform agency policymaking and guidance on increasing the safety of sprout products, which have been associated with repeated disease outbreaks.
28. Sprouts Sampled and Analyzed – In 1997, FDA and the California Food and Drug Branch conducted a joint survey of the agricultural practices of the sprout industry in California. In 1998, following the survey, FDA initiated a sampling and testing program to check bacteria levels in production facilities and finished products of about 100 sprout firms. This assignment, ordered in the wake of repeated problems with pathogens in sprout products, is ongoing and will continue into the fall of FY 1999. Data obtained will provide baseline information to the agency and the industry, and help define the scope of the problem with sprouts as well as possible steps to increase sprout safety.
29. Public Meeting Convened on Sprout Problems – In September 1998, FDA convened a public meeting to discuss methods to improve the safety of sprouts. The meeting was part of a continuing effort by public health agencies and the sprout industry to reduce the risk of foodborne illness that has been reported in increasing numbers in recent years. Conclusions and recommendations from the Produce Working Group of the National Advisory Committee on Microbiological Criteria for Foods include the fact that research has shown that no single treatment is currently available that can assure elimination of pathogenic bacteria; sprout growers are in fact food manufacturing facilities and as such are subject to FDA rules for good manufacturing practices regulations; and that sprouts are cultivated and stored in conditions that are conducive to bacterial growth. Further, the Produce Working Group recommended that the sprout industry begin to apply HACCP principles to their growing operations and that the sprout industry associations educate their members about the importance of good manufacturing practices.
30. Cut Vegetables Sampled and Analyzed – Beginning in January 1998, and continuing until June, FDA operated a special inspection and sampling program at about 100 firms producing fresh cut vegetables to check these products for microbial pathogens. The assignment was undertaken in the wake of outbreaks of disease associated with fresh vegetable products.
31. Pilot HACCP Program for Retail Food Safety – In April 1998, FDA announced a pilot program to implement HACCP hazard-control programs for the retail sector of the food industry including restaurants, grocery stores, institutional food service and vending operations. Volunteer establishments are working with FDA and state and local authorities in implementing model HACCP programs to keep food safe at their retail levels.
32. Irradiation Approved for Red Meat – In December 1997, FDA approved the use of irradiation on meat products for controlling pathogens. The approval provides another tool to protect meat products from contamination with disease-causing microorganisms.
Ensure the Safety of Imported and Domestic Produce
33. Guidance Issued on Safe Production and Processing of Produce – In October 1998, FDA published its Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, also termed the "Good Agricultural Practices/Good Manufacturing Practices" or "GAP's and GMP's" guidance. A draft was issued In April for public and industry comment. The draft itself was developed with public input gathered at a series of six public meetings held around the country during November and December 1997. Three more public meetings were held in May 1998 following the publication of the draft to allow additional public input on development of the final document. The guide addresses key areas where precautions should
be taken to ensure safety: water quality, worker hygiene, field and facility sanitation, manure management, and transportation.
34. NACMF Finalizes Recommendations for Microbial Safety of Fresh Produce – In 1995, FDA and CDC asked the National Advisory Committee for Microbiological Criteria for Foods to investigate and characterize the association of foodborne disease and microbiological pathogens in fresh produce. In March 1998, NACMF issued a final white paper on the subject.
Producer Education
35. Educational Outreach program for the GAP's/GMP's Guidance - FDA is working with USDA to develop an educational outreach program for the Good Agricultural Practices/Good Manufacturing Practices guidance for fresh fruits and vegetables.
36. International Producer Education – An International Working Group of representatives from FDA, USDA, USTR, USAID, and the State Department has been organized to discuss technical assistance opportunities for foreign countries. A country-by-country infrastructure needs assessment will be part of the 1999 international and domestic producer education conference.
Retail Education
37. FSTEA " FDA has joined with other federal agencies, industry association, academia, state/local regulatory associations, and consumer representatives in establishing the "Food Safety Training and Education Alliance for Retail, Food Service, Vending, Institutions and Regulators." This group (FSTEA) is working to promote training of government and industry employees in retail food service. FSTEA has begun an evaluation of existing training resources listed in the National Agriculture Library's Foodborne Illness Education Information Center database, and has developed instruments to perform a needs assessment for educational materials and for multi-lingual training materials. FSTEA has developed training competencies for food safety regulators and begun a similar process of identifying competencies for food safety trainers and retail establishment managers and workers.
38. State and Local Retail Food Regulatory Staff Training " FDA offers 30 training courses for state and local retail food regulatory staff through its State Training Branch and provides "training courses in a box" through its lending library. A special Microbiology for Inspectors satellite course was offered during FY 1998 as part of FSI and a follow up course, Investigation of Foodborne Illness will be held in FY 1999.
School-based Education
39. Bringing the Farm-to-Table Food Safety Initiative to Classrooms Nationwide – Research into planning future school-based education activities culminated in a report titled USDA/FDA Education Initiatives: Evaluating the Placement of Food Safety Education in Schools. Research results concluded that science would be the most effective subject area and that middle and high school would be the most appropriate grade levels for food safety education in the schools. Based on the results of this evaluation, a collaborative program is underway involving FDA, USDA, and the National Science Teachers Association in development of a supplementary science curriculum on food safety. The program will be ready for distribution in September 1999.
Consumer Education
40. FIGHT BAC!TM Campaign Activities Continue – FDA, in collaboration with USDA and CDC continued its support of the public-private Partnership for Food Safety Education's FIGHT BAC! (for fight bacteria) campaign. Highlights of this year's efforts included:
41. National Food Safety Education Month Program Celebrated – September 1998 marked the celebration of the fourth annual National Food Safety Education Month (NFSEM). Launched by the restaurant and food service industry in 1995, NFSEM's primary goal is to focus public attention on foodborne illness and safe food handling practices that consumers and commercial food workers can follow to stay healthy. NFSEM Planning Guides, prepared by FDA and USDA ,were distributed to Federal, state and local agency food safety educators and health organizations across the country. The guides contained food safety information, tools and ideas which could be used for NFSEM activities. FDA public affairs specialists throughout the country engaged in grassroots activities in support of NFSEM. Among the many activities taking place were: food safety presentations to Meals-on-Wheels programs and senior centers; development of food safety teaching aides for low income families; promotion of food safety contests on radio talk shows; and translation and distribution of FIGHT BAC! educational materials in Spanish, Chinese, Korean, Vietnamese, Hmong, Laotian, Cambodian, Tagalog and Hindi.
42. Food Safety Initiative Grants Fund Grassroots Projects –In addition to the NFSEM projects above, FSI education grants awarded to FDA public affairs specialists around the country funded a wide variety of grassroots food safety initiatives. These include training church food handlers in Cincinnati and Cleveland, programs for Hispanic consumers in Florida, Puerto Rico and New York City, and training trainers to work with older consumers and consumers with HIV/AIDS in Florida.
43. National Food Safety Information Center – FDA has joined with USDA and CDC to bring together the Federal government's primary mechanisms for providing food safety information to the public. The Center consists of : FDA's Food Information Line, USDA's Meat and Poultry Hotline, USDA/FDA Foodborne Illness Education Information Center; <foodsafety.gov> website; the National Food Safety Educator's Network (EdNet), and Foodsafe, an electronic dissemination system. Segments of the Information Center are operational now, the rest will be in early 1999.
44. Consumer Research Undertaken – Research was completed on the use and acceptance of food labels and other point-of-sale materials to convey food safety information. This information formed the basis of the juice warning label policy and the proposed label for the safe handling of eggs.
45. Public Education Campaign on Untreated Juices – FDA launched a public awareness campaign on the risk that unpasteurized or untreated fruit and vegetable juices may present to vulnerable populations. The campaign targets the population sub-groups most vulnerable to the effects of infection, young chidren, older persons and immunocompromised individuals. Educational materials include a press kit, consumer brochures, video news release and a public service announcement were distributed to health professionals, senior citizen groups, daycare centers, elementary schools, and to the media, among other outlets.
46. Advisory on Sprouts – FDA issued an advisory that children, the elderly and people with compromised immune systems should avoid eating raw alfalfa sprouts due to the increased risk of pathogens.
Public Health Professionals Training
47. Agreement with AMA Signed – FDA and CDC signed an agreement with the American Medical Association (AMA) to develop a program to educate physicians on foodborne disease and clinical microbiology and foodborne illness with non-traditional symptoms.
Food Safety Research Funded
48. Food Safety Research Funded " In FY 98, FDA funded eight new research and risk-assessment grants totaling $2 million. The projects include studies on methods to prevent E. coli O157:H7, Salmonella and Listeria contamination of fruits and vegetables; antimicrobial treatments for sprouts and sprout seeds; dose-response models for foodborne Cryptosporidum parvuum, Listeria, and Vibrio; the pathogen-related DNA structure of E. coli O157:H7; and how consumer food preparation practices can be enhanced to reduce the risk of foodborne illness.
Also in FY 98, FDA funded seven cooperative agreements totaling $1 million with outside research organizations to study the microbiological hazards associated with the food animal production environment, which includes animal feeds. The projects include studies of on farm risk factors for zoonotic enteropathogens asscociated with cattle feed and water, waterborne dissemination of E. coli O157:H7, salmonella virulence and antibiotic resistance in cattle and feed, factors affecting numbers of acid-resistant E. coli in cattle, survey of antimicrobial resistant Enterococci in animals, control of EHEC in cattle by probiotic bacteria, and evaluation and use of BAM/FDA and rapid methods for on-farm survey.
Research Planning and Coordination
49. FDA Food Safety Research Plan Issued – In May 1998, FDA issued a three-year research plan that outlines the microbiological and microbial risk assessment research that CFSAN is conducting to support the Food Safety Initiative. The plan is specifically coordinated with other federal agencies to avoid duplicative research and target the most promising research areas.
50. Federal Research Coordinated – In May 1998, federal food safety agencies issued a coordinated interagency research plan to guide food safety research at the federal level. The plan was developed with input from industry, academia and consumers. The plan's purposes are to steer federal food safety research to those areas with the most potential for providing real-world food safety benefits, avoid duplicative research, and to get the best use possible out of food safety research dollars.
51. Joint Research Plan for Produce Issued – In collaboration with USDA and other federal agencies, FDA developed a broad research plan to enhance the safety of fresh fruits and vegetables.
52. Cooperative Agreements Reached for Dose Response Studies – FDA established three cooperative agreements to study dose response to Vibrio spp. and Cryptosporidium parvum in humans and Listeria monocytogenes in primates. Mechanisms were established to perform collaborative studies with cooperative agreement awardess to extend animal studies by using additional model systems and bacterial strains and to develop biomarkers of host response and susceptibility in humans and animal models.
53. Coordinated Poultry Research – In FY 98, working relationships with the University of Maryland/Joint Institute for Food Safety and Applied Nutrition, USDA-ARS and FDA's CVM were established to provide a source for chicken tissue samples and to conduct experimental infections of birds. In addition, methods to measure immune parameters of chickens (layers) were developed.
Research Accomplishments
54. Research Initiated on Safe Sprout Production – In August 1998, FDA initiated additional research on sprout safety at the National Center for Food Safety and Technology (Moffett Center) in Chicago, operated in partnership with Illinois Institute of Technology. An actual sprout production facility has been constructed at the Center. Research will evaluate the effectiveness of intervention strategies such as sanitizing agents to prevent contamination of sprouts with pathogens.
55. Juice Research Facility Established –In September 1998, FDA began research on how to prevent contamination of unpasteurized juice. The agency leased a cider mill in Placerville, California to operate as a research site in partnership with the California Department of Health and Human Services, the Eldorado County, Calif., Department of Agriculture, and the National Center for Food Safety and Technology (Moffett Center). Research will assess effectiveness of different antimicrobial technology such as chemical sanitizers, ozone and ultraviolet light. Findings will be valuable to regulators and industry alike, and should help develop and implement preventive controls to assure the safety of unpasteurized juice products.
56. Quick Test to Identify E. coli Developed " FDA developed an improved technique to directly detect and quantify harmful E. coli within 30 minutes, reducing detection time from 24 to 48 hours using conventional techniques. The method, using fluorescent microscopy, has been utilized by the meat industry, particularly ground beef producers.
57. E. coli Identified through New DNA-based Technique – FDA developed a DNA-based technique to detect E coli O157:H7 and other related bacteria that is faster and more sensitive than current methods. Two patents, for the DNA sequence and for detection kits, and licenses were awarded. A Cooperative Research and Development Agreement was signed with a company to develop this test kit commercially.
58. Intervention Technology Developed to Eliminate/Inactivate Microbial Contaminants – FDA developed an intervention technology to eliminate or inactivate microbial contaminants by the use of high hydrostatic pressure (80,000-120,000 psig) techniques. This technique is run at ambient to moderate temperatures, and kills the organisms but retains fresh sensory characteristics of the products. This technique has been shown to inactivate a number of different pathogens in packaged or fluid products.
59. Method Developed to Improve Detection of Ochratoxins in Grains - FDA Developed a method that increased speed and simplicity of detection of ochratoxins in grains. Most important, the method increased detection sensitivity to 5 ppb, the standard recently proposed by the Codex Alimentarious Committee on Food Additives. A limited survey demonstrated that 99% of US grain met this higher standard.
60. Norwalk Viruses Isolated from Shellfish – FDA solved the decades-old inability to isolate Norwalk viruses from shellfish by developing a rapid, sensitive and reliable method capable of detecting low levels in contaminated shellfish. To accomplish this task FDA investigators overcame the naturally occurring PCR inhibitors in shellfish tissue, potentially low levels of virus contamination, and inefficient methods to separate and recover viruses. Until this method was developed there was no direct proof that shellfish transmit viral disease from contaminated waters to humans. With this development the public health community and the shellfish control authorities now have a tool to prevent future outbreaks and secure a safer shellfish supply.
61. Infant Rabbit Model Developed to Study E. coli" An infant rabbit model to study the virulence of enterohemorrhagic Escherichia coli. Was established and used to demonstrate the role of EHEC EepA extracellular protein in virulence. With wildtype isolates, a dose-response relationship in both the time of onset of clinical disease and in the severity of disease that develops, was demonstrated.