Thank you for the opportunity to provide comments on the National Food Safety Initiative and to participate in the process to identify issues and approaches that will lead to the development of a comprehensive food safety plan to protect the public against foodborne disease. The American Society for Microbiology (ASM) is the largest single life science society in the world with over 42,000 members. ASM members include individuals working in academe, public health, clinical laboratories, industry, veterinary medicine, agriculture and government. Many of our members are engaged in the research, detection, diagnosis, prevention and surveillance of foodborne disease.

The ASM would like to commend the Administration for focusing on the problem of microbial foodborne disease and emerging pathogens as outlined in the National Food Safety Initiative. Overall, the ASM concurs with the principles and strategy outlined in the Initiative. However, there are issues within the key areas that have not been adequately addressed. We would like to focus our comments on issues which we believe are in need of further attention. One of our key areas of concern is the omission of the National Institutes of Health (NIH) and, specifically, the National Institute of Allergy and Infectious Diseases (NIAID), from involvement in the early planning of the Initiative. We urge that the NIH and the NIAID, which is the federal government's lead agency for sponsoring scientific research on the causes of infectious disease, pathogenic mechanisms, host defense mechanisms, vaccines and antibiotics, be included in the future development of the food safety plan to ensure that their expertise is brought to bear on this growing threat to public health.

First, we congratulate the Administration for allocation of resources in the FY 1998 budget specifically for the implementation of the Food Safety Initiative. We also commend the Centers for Disease Control (CDC), the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) for protecting the nation's food supply even with limited resources. Research and the public health infrastructure related to food safety have been very underfunded for the past decade. We would like to bring to the attention of the Administration and Congress that the proposed funding in FY 1998 is not adequate to address the complexity and magnitude of the problems associated with food safety. Additional new and sustained resources will be needed to achieve the goals of a comprehensive plan that still needs to be developed to ensure food safety, not only in the short term but over the long term.

To be effective it is absolutely essential that the Food Safety Initiative be coordinated across the federal government agencies and with local and state government health authorities. The FDA, CDC, NIH, USDA and the Environmental Protection Agency (EPA) need to work collaboratively on foodborne disease research and prevention activities. However, the Food Safety Initiative does not clearly state how interagency coordination will be achieved. One approach would be to designate a lead federal agency and establish an interagency coordinating committee. We strongly support the Foodborne Outbreak Response Coordinating Group and recommend the participation of the public in the deliberations of this group, including representatives from industry and the scientific community. There should be clearly delineated lines of authority and jurisdiction for this group. The ASM recommends that the risk assessment consortium involve all government agencies conducting research in this area and include industry and academic representatives as part of the group.

The new National Early Warning System for public health surveillance is a key element of the Food Safety Initiative. An effective national and global surveillance system is critical to maintaining a strong defense against infectious diseases, including foodborne diseases, that affect, or threaten to affect, the public's health. We applaud the allocation of $10 million in the Centers for Disease Control and Prevention's FY 1998 budget which will enable CDC to implement a number of activities related to food safety surveillance and about $3 million in the Food and Drug Administration's budget for surveillance efforts. We believe this effort should enhance the capacity of the current seven FoodNet sites located at state health departments to serve as centers of excellence that define the needs for foodborne disease surveillance for the entire country. In turn, it will be necessary to take the findings from the FoodNet effort and implement appropriate surveillance in state and local health departments nationwide. New resources are needed for information technology which is vital for sharing information on organism typing collected by surveillance sites throughout the country with other laboratories and facilities. Public health laboratories are in need of additional resources and expertise to produce and share surveillance data.

The Food Safety Initiative should encourage the participation of the private health care delivery system in national surveillance. The managed care industry and the physician community should become partners with their state health departments and with the CDC to ensure that foodborne disease continues to be diagnosed accurately and reported. For example, stool cultures need to be collected and laboratory diagnosis performed on a patient presenting with diarrheal illness in order to detect, isolate and diagnose the infecting pathogen and to treat it with the correct antimicrobial therapy.

Managed care organizations and insurance companies should be educated about the impacts their decisions and practices are having on foodborne disease surveillance and prevention in this country. They should be full fledged participants in the Food Safety Initiative. Another essential component to an effective surveillance system is the need to have trained and qualified clinical microbiologists available to perform critical laboratory diagnoses and to recognize the emergence of new pathogens.

Foodborne surveillance data should be communicated to industry in a cooperative, efficient and timely manner. Scientific experts from industry should also provide expertise on processing and distribution issues in outbreak investigations to assure that assumptions made in epidemiological investigation are valid. With complete information, industry and public agencies can effectively respond to outbreaks and implement new strategies for more effective control. It is important that scientific data be carefully subjected to thorough analysis, review and interpretation prior to public communication and dissemination.

Animal population and disease surveillance is also critical to solving the food safety problem. Animal to human disease transmission is an emerging public health threat that needs to be examined further. Risks associated with the public acquiring antimicrobial resistant pathogens from food animals are also of great concern. The ASM supports the FDA Center for Veterinary Medicine in its efforts to establish an Antimicrobial Susceptibility Monitoring Program using both human and animal isolates and recommends that this program be considered for increased funding in the fiscal year 1999 budget and include the CDC and the USDA.

Additional research is urgently needed so that changes in current food safety practices will be guided by valid scientific data. The Food Safety Initiative correctly identifies research as a high priority. However, the FY 1998 resources allocated for infectious disease research and for specific areas of needed research outlined in the Initiative are insufficient. It is essential to develop a research agenda that will effectively develop methods and technologies to prevent foodborne disease. For instance, such an agenda could include the following research areas: microbiological hazards in water used to irrigate produce fields; the use of antibiotics in livestock to control infection and the use of probiotics in livestock to control pathogens; the safety of food products imported from other countries; processing and slaughter practices; and food formulation and handling practices that can prevent illness such as new preservatives and antimicrobials, safety testing of modified products (e.g. reduced fat, reduced sodium foods that may allow enhanced growth of pathogens), terminal pasteurization processes (e.g. pulsed electric fields, irradiation, high pressure, etc. ) that could inactivate organisms in foods, and identifying innovative control methods to kill acid-tolerant pathogens such as E. coli O157:H7 in acidic foods that until recently had a history of being safe.

A serious omission of the Initiative is the need for basic and clinical research. Surveillance tells us when and where a disease appears unexpectedly or dramatically increases in incidence. However, surveillance is only as good as the methods used for detection. A sustained basic and clinical research program in foodborne pathogens is necessary to provide the tools needed to detect and control these diseases. Clinical research is needed to determine health risks from foodborne pathogens and subsequently to establish meaningful risk management programs. Basic research in microbial physiology and genetics is needed not only for development of rapid, sensitive, and cost effective diagnostic tests but also to provide better understanding of an organism's ability to respond to environmental stress and to survive in food products. New foodborne pathogens have emerged over the past decade and established pathogens have developed increased virulence and antimicrobial resistance. We need to know the agents responsible for enteric infection and research will help define the scope and etiology of the problem. Thus, the need for a sustained research program.

For example, we know little about the mechanism of colonization, pathogenesis and importance of strain variation of Campylobacter jejuni. Furthermore, enhanced detection methods are needed for this fastidious organism. Another needed area in research is the role of strains of E. coli other than O157:H7 in foodborne disease and the potential need for inclusion of these strains in surveillance programs. Research is also needed to determine the role of astrovirus and caliciviruses in foodborne disease. In short, there is a great need to determine the overall microbial content of different food products, especially fresh fruits and vegetables, and then to assess their health risks. Only limited data are available concerning the presence of fastidious bacterial, viral and parasitic pathogens in food and the resulting health risks. The latter is particularly important because in at least 50 percent of cases of diarrhea the etiology remains unknown.

Given the critical role of basic and clinical research in the area of food safety, it is unclear why the Food Safety Initiative does not include the National Institutes of Health, specifically the National Institute of Allergy and Infectious Diseases. Research supported by NIH has provided much of our basic knowledge about many of the major foodborne pathogens, including Salmonella, Shigella, Campylobacter, E. coli O157:H7, Clostridium botulinum, Listeria monocytogenes, and Vibrio. Also, regarding the potential role of other important federal programs in Food Safety Initiative, the Department of Defense and NASA have invested heavily in development of large scale, sensitive detection methods for viral and bacterial pathogens in environmental specimens. The Food Safety Initiative should take advantage of this existing infrastructure. In addition, the Food Safety Initiative should emphasize the critical role that the academic and industry research communities play in providing solutions to problems associated with foodborne diseases.

Education efforts should be given high priority in the Food Safety Initiative. The federal government should assume responsibility for the coordination and funding of educational programs relating to foodborne disease as soon as possible. The United States Department of Agriculture and the Centers for Disease Control and Prevention should be charged with developing and managing public/consumer education campaigns and given the appropriate resources to do so. Targeted campaigns to particular populations (elderly, children, immunocompromised) should also be developed and funded. In addition, targeted campaigns to industry (food service, retail, and food handlers) should be conducted.

Federal oversight must assure uniform understanding and administration of regulatory requirements that are shared with state and local agencies. Finally, while the ASM believes that, overall, Hazard Analysis Critical Control Point (HACCP) is the best approach for enhancing our nation's food supply, the imposition of mandatory HACCP is not necessary for all foods. Provisions must be made for alternative approaches to ensuring safety as long as they are demonstrated to be effective.

We appreciate the opportunity to provide comments and recommendation on the National Food Safety Initiative. The ASM would be pleased to respond to any questions or to provide additional information.