Food Safety and Inspection Service United States Department of Agriculture Washington, D.C. 20250-3700

Speeches

The Food Safety Research Agenda--
Emerging Microbial Pathogens and Issues

Remarks prepared for delivery by Dr. Catherine Woteki, Under Secretary for Food Safety, before the Beef Safety Symposium sponsored by the National Cattlemen's Beef Association and the American Meat Science Association, December 3, 1997, Chicago, Ill.

It's a pleasure to join you today to discuss emerging pathogens and issues in beef and how they affect the future agenda for food safety research. Before I was confirmed as Under Secretary for Food Safety, I served as Acting Under Secretary for Research, Education, and Economics, where I oversaw all food and agricultural research carried out by USDA. So I have a great interest in food safety research.

We especially appreciate your interest in food safety research, because we recognize that our efforts alone cannot be expected to address all food safety research needs. We must involve other government agencies, academic institutions, professional organizations, and the industry, to meet our research objectives in a timely manner. Meetings such as this one provide a forum for us to discuss what those needs are and how we can best achieve our goals.

Public Health Goals

Of course, all of our activities, whether they involve research, regulation, or education, focus on the important goal of reducing the incidence of foodborne illness. And that is indeed a formidable challenge. In the United States, the Centers for Disease Control and Prevention estimate that foodborne microbial pathogens account for up to 33 million cases of foodborne illness each year, and up to 9,000 deaths.

At the same time, the solutions to food safety problems are also becoming more and more complex, for many reasons. We have new food products with new food safety concerns. We have an increase in elderly and immune-compromised persons who are at higher risk of severe illness.

Emerging Pathogens

And, as the theme of your conference indicates, we have emerging pathogens and other emerging issues related to food safety. At a recent conference at Georgetown University on E. coli, I discussed how that pathogen is responsible for changing the Nation's mind set about foodborne pathogens. It's such a tiny organism, but is responsible for such a large impact. Less than a decade ago, the pervasive attitude among industry--and even among some regulators--was that bacteria, including pathogens, are a natural part of the environment and can't be controlled. The idea that government would begin setting standards for pathogen reduction, and testing raw products for bacterial contamination, was beyond belief.

Today, things have changed. We must focus on emerging pathogens such as Salmonella typhimurium DT104 and new strains of E. coli. We must be vigilant to trends in other countries, such as the emergence of BSE in Europe.

We also must be open to new paradigms regarding pathogens. What worked in the past may not necessarily work now or in the future. For example, we are finding pathogens on foods initially thought of as "safe." Produce, eggs, and fruit juices are examples. We are also encountering emerging antimicrobial resistance. And pathogens are adapting to traditional processing procedures and developing the ability to survive changes in pH, heat, and drying.

Food Safety Strategy

USDA has embarked on a number of changes to address these challenges.

First, we are making significant changes in our regulatory programs for meat and poultry by placing a new emphasis on controlling microbial pathogens. The final rule on Pathogen Reduction and HACCP, which was published in July 1996, sets new requirements for meat and poultry slaughtering and processing plants. By January 1997, all plants were required to implement standard operating procedures for sanitation, and slaughter plants were required to begin testing for generic E. coli, as a means of evaluating process control. In January 1998, plants will begin implementing Hazard Analysis and Critical Control Point (HACCP) systems and will be required to meet performance standards for Salmonella in raw products.

USDA is also implementing a farm-to-table strategy. From the very beginning of developing the HACCP rule, we have known that an effective food safety strategy must address the entire farm-to-table chain, not just what goes on within inspected plants. Our authority outside of plants is limited, but we are making progress by working closely with other government agencies, professional groups, academia, and industry.

The Food Safety and Inspection Service also recently underwent a reorganization to better operate in a HACCP environment that emphasizes the prevention of foodborne illness. One objective of the reorganization was to strengthen the Agency's focus on public health. Within the new Office of Public Health and Science, we have established several new divisions responsible for addressing epidemiology and risk assessment, emerging pathogens, food hazard surveillance, and emergency response to outbreaks of foodborne illness.

Food Safety Research Today

Research is very important to the success of these food safety initiatives. In order to effectively address the safety of meat, poultry, and egg products, we need to know more about the hazards in these foods and their relation to illness. Our programs must be responsive to new information and new data. And because our food safety strategy has broadened to cover the farm-to-table continuum, our research agenda must also address the entire continuum.

Agricultural research is now a shared responsibility of both the public and private sectors, and I'd like to take a few minutes to look at the current state of food safety research conducted today.

The Federal government has played a major role in supporting agricultural research for over a century. While farming was the traditional focus of Federal agricultural research during the last century, the demands placed on the U.S. agricultural research system are changing. Today, society's interest in agricultural research is more complex, with consumers expecting a wider set of issues to be addressed, including consumer health, food safety, and environmental protection.

(Slide #1)

The Federal government supports intramural research through the Agricultural Research Service, the Forest Service, and the Economic Research Service. It also funds extramural research at State institutions, which is administered by the Cooperative State Research, Education, and Extension Service. This strong intramural research base is needed because there are research problems and issues of national importance that may receive too little attention from individual States or regions. This research also serves the needs of the regulatory and action agencies.

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In 1992, nearly two-thirds of the $1.55 billion spent by the Federal government for agricultural research went for in-house research at USDA agencies. The remaining third was distributed to State institutions. The private sector funded $3.8 billion in research conducted in their own facilities or by universities.

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However, the lack of growth in Federal agricultural research expenditures constrains the ability of the public agricultural research system to respond to new demands. Federal expenditures have not grown in real terms since the mid-1970's.

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It is difficult to determine how much of the public funds for agricultural research are devoted specifically to food safety, because this research is often incorporated into other areas such as food science and animal health. It is clear, however, that food safety receives a very small percentage of research dollars.

(Slide #5)

Data from the Current Research Information System (CRIS) maintained by USDA, shows three categories where research monies for food safety were allocated in 1995. ARS priorities include bacterial physiology, ecology, pathogenesis, growth dynamics of pathogens, and methods of predictive microbiology in various food matrices. ARS is carrying out approximately 35 projects at FSIS request.

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Turning to the private sector, it is also difficult to really know how much food safety research is done in private industry, but we do know that private research tends to be more commercially oriented than public research. And we also know that over the past 30 years, the importance of the private sector in both funding and conducting agricultural research is growing.

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There has also been a shift in emphasis in the type of agricultural research conducted in the private sector, with the private sector developing significant research capacity in areas such as farm chemicals, plant breeding and animal health.

Agricultural research will continue to require involvement by the Federal government in areas where private incentives are weak, and many aspects of food safety research fall into this area. But I believe the growing importance of food safety and the impact it can have on businesses are providing a growing incentive for private industry to support fundamental, as well as applied, food safety research. I believe this mutual interest in food safety research provides opportunities for partnerships in the future.

(Slide #8)

Food Safety Research Agenda

FSIS is not a research agency, however, and it must reach out to other research agencies within the Federal government, and to the private sector, to meet its research needs.

For that reason, in 1996, the Agency developed a Food Safety Research Agenda as one means of communicating with those outside the Agency about its priorities in food safety research.

As a first step, FSIS established a Food Safety Research Working Group, which was composed of scientists representing a broad base of expertise. The group included representatives from various USDA agencies as well as from the Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Department of Defense. The group's task was to establish a research agenda that supports the changes FSIS is making in its food safety programs.

(Slide #9)

The working group used human health effects as the basis for determining FSIS research needs, which is consistent with the risk assessment framework recommended by the Council for Agricultural Science and Technology (CAST) and the National Academy of Sciences (NAS).

Using the criteria, the working group reached a consensus on the major research questions that needed to be answered. They identified general research questions as well as research needs that are unique to the following pathogens--Salmonella, Campylobacter, Listeria, and Enterohemorrhagic E. coli, including E. coli O157:H7. Page 7 of the report lists 10 general research questions applicable to all pathogens.

(Slide #10) These are the questions that were developed for E. coli.

The questions that the working group developed are important for several reasons. First, because the group used public health criteria as a means of determining research priorities, we can consider the pathogens identified by the group to be the major pathogens of concern for future research. Thus, Salmonella, Campylobacter, Listeria, and Enterohemorrhagic E. coli and E. coli O157:H7 are the pathogens about which we are most concerned. I encourage you to consult the research agenda for the specific research questions for each of these pathogens.

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Second, the research agenda reflects the direction taken by the President's Food Safety Initiative, which was announced in January of this year. The President's initiative supports the use of risk assessment as a means of characterizing risks to human health associated with foodborne hazards and assisting regulators in making decisions about where in the food chain to allocate resources to control those hazards. It targets virtually all of the pathogens emphasized in our research agenda as areas requiring short- and long-term research goals. And it supports the inclusive process through which the research agenda was developed. A wide spectrum of government agencies, including those with public health expertise, were involved in the process of determining research needs.

Our research agenda is also in keeping with the Government Performance and Results Act of 1993, often referred to as the Results Act, which calls on all Federal agencies and departments to coordinate their activities to be more effective, efficient and to avoid duplication.

Challenges for the Future

The challenge for the future will be to integrate all of the research needs stated in the FSIS Research Agenda and the President's Food Safety Initiative, into an operational plan that reflects the emphasis on cooperation and partnerships. To assist in this process, the President's Food Safety Initiative calls for the convening of an interagency working group by the White House Office of Science and Technology Policy, to coordinate Federal research priorities and planning. The goal of this working group will be to develop a coordinated Federal food safety research plan, which will extend to our research partners in States, industry, and academia. This committee is now in the process of being formed, and we hope to hold the first meeting of the working group this month.

Closing

I would like to end my remarks with a few words about risk assessment.

Risk assessments are vitally important to our ability to determine the public health hazards associated with pathogens. Because risk assessment is a relatively new science, we need investment at the ground level. USDA's Agricultural Research Service is doing a lot of work in computer modeling, which is enabling us to be able to conduct these risk assessments, and FDA is making a major investment in a new center with the University of Maryland to focus on risk assessment. But in addition to the technology, we need the funds to develop new methods and to carry out such assessments. Appendix 2 in the Research Agenda--a Fault Tree Analysis for E. coli O157:H7 in ground beef--highlights areas where data are missing and we need to target research.

In closing, I hope I have succeeded in providing USDA's perspective on food safety research and in describing our research priorities. For the future, we would like to see industry determine what direction it wants to take in food safety research. Is the traditional division of labor and responsibilities for the private and public sectors consistent with making the best use of valuable research dollars? Should we continue to follow the tradition of more fundamental research questions being left to the Federal government and universities? Is the current Federal investment sufficient to meet food safety concerns and are our priorities appropriate?

I look forward to hearing the answers to these, and many more questions, as we work together to meet our food safety research goals.

For Further Information Contact:
FSIS Food Safety Education and Communications Staff
Public Outreach and Communications
Phone: (202) 720-9352
Fax: (202) 720-9063

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