USING RISK ANALYSIS TO INFORM MICROBIAL FOOD SAFETY DECISIONS

INTRODUCTION Business and governments have used both formal and informal processes to make food safety decisions. In the past, scientific data, as well as other technical, economic, and consumer research have served as the basis for much of the decision-making process, including the determination of whether the benefit of an action outweighed its costs. Data gaps always exist, however, and when data are available, it often is difficult to compare multiple research studies with each other, especially when study design, results, and/or conclusions vary or differ. Although subjective approaches for estimating risk have been used in the past, a systematic method was lacking to analyze available information and knowledge and evaluate consequences of different food safety control measures on public health. In short, policymakers have not had a structured approach for making choices among a variety of management options. Furthermore, communication with stakeholders often has been overlooked or delegated to public affairs and media relations staffs only after the decisions have been made. Protecting the public from food safety risks, while maintaining a viable agricultural and food industry in an open society, is a daunting task. Competing stakeholder interests, legal scrutiny, public awareness, media coverage, and the inherent uncertainty of all these complex issues impinge on the food safety decisionmaking process now more than ever. Risk analysis provides a systematic and transparent process for gathering information, estimating risks, weighing options, drawing conclusions, and communicating information to arrive at decisions that meet broad societal needs. This approach routinely is applied to managing chemical hazards in food and in the environment. More recently, risk analysis has been applied and expanded to the assessment of microbial public health threats, including minimizing infectious and toxigenic hazards. At a very basic level, risk analysis is a tool to foster complex problem solving and decision making. It is used increasingly to help solve food safety problems and better understand the complex interactions of pathogens, food, and human hosts. TASK FORCE MEMBERS: Lee-Ann Jaykus, Cochair, North Carolina State University, Raleigh; Sherri Dennis, Cochair, U.S. Food and Drug Administration, College Park, Maryland; Dane Bernard, Keystone Foods, West Conshohocken, Pennsylvania; H. Gregg Claycamp, U.S. Food and Drug Administration, Rockville, Maryland; Daniel Gallagher, Virginia Polytechnic Institute and State University, Blacksburg, Virginia; Arthur J. Miller, *U.S. Food and Drug Administration, College Park, Maryland; Morris Potter, U.S. Food and Drug Administration, Atlanta, Georgia; Mark Powell, U.S. Department of Agriculture, Washington, D.C.; Donald Schaffner, Rutgers University, New Brunswick, New Jersey; Mary Alice Smith, University of Georgia, Athens; Toby Ten Eyck, Michigan State University, East Lansing REVIEWERS: Michael Batz, Resources for the Future, Washington, D.C.; Robert Buchanan, U.S. Food and Drug Administration, College Park, Maryland; Leon Gorris, Unilever, Sharnbrook, United Kingdom; Susan L. Santos, FOCUS GROUP Risk Communication and Environmental Management Consultants, Medford, Massachusetts and the University of Medicine and Dentistry of New Jersey School of Public Health, Piscataway; CAST BOARD LIAISON: Harold Swaisgood, North Carolina State University, Raleigh