Society For Risk Analysis Annual Meeting 2003

W7 - Symposium: Pathogen Performance Standards: Insight from Risk Assessment and Economics - Sponsored by the Food/Water & Economics Specialty Groups

Chair: Tanya Roberts

Growth in international food trade and concern about terrorism has propelled food safety to a high position on many policymakers' lists of important policy issues. However, even in the absence of major trade-related outbreaks, foodborne illness is a costly problem. In the United States, for example, there are an estimated 76 million cases of acute foodborne illnesses each year, with outcomes that include death and chronic complications, such as arthritis, kidney failure, paralysis, or mental retardation. The economic costs for five U.S. foodborne pathogens are estimated at $6.9 billion annually in medical costs, productivity losses, and premature death. Countries have developed various methods to assure domestic food safety and safety in trade and the World Trade Organization and CODEX Alimentarius have international standards and committees. This symposium addresses a number of technical and policy challenges in the use of risk assessment to construct and justify risk-based performance standards. The array of policy options, including priority setting and pathogen performance standards, that are being developed and used to control foodborne pathogens in national and international commerce will be described. The economics of pathogen performance standards will be examined, along with lessons learned from environmental economics, the impact on food safety innovation, trade and other economic dimensions. The speakers represent a variety of disciplines: microbiologist, economist, risk assessor. The topic is particularly relevant to the 2004 meetings, since Food Safety Objectives are being implemented internationally and both the USDA/FSIS and DHHS/FDA have incorporated pathogen performance standards into their food safety regulatory systems.

W7.1 Peeling the Onion of Performance Standards for Foodborne Pathogens. Paoli, G. M.*, and Fazil, A.; Decisionalysis Risk Consultants, Ottawa, Ontario, Canada, and Laboratory for Foodborne Zoonoses, Health Canada, Guelph, Ontario

Abstract: Internationally through the proposed use of Food Safety Objectives, and in domestic food policy, risk-based performance standards are frequently advocated for foodborne pathogens. To date, there has been limited detailed analysis of technical issues in developing and implementing a risk-based performance standard for pathogens. We suggest that the reality of the standard-setting process has far more complexity than is generally accounted for in current documentation and debate. Challenges in development stem from five main sources: (i) the need for formal valuation of the relative importance of avoiding diverse potential health outcomes; (ii) consideration of some limitation to the burden on food processors given the contribution of downstream food handling to the overall risk; (iii) the rare-event nature of foodborne illness on a per-serving basis and the potential futility of measuring and improving the "average" performance in food processing; and (iv) determination of the set of measurable outcomes in a food processing facility that would be truly representative of acceptable risk. In this paper, these challenges are explored using examples and potential solutions are offered.


W7.2 Economics and Pathogen Performance Standards. Elise Golan; Economic Research Service, USDA

Abstract: This talk reviews the economic theory behind economists' endorsement of performance standards and examines a number of practical issues that may complicate the application of performance standards for food safety. Economists typically argue that performance standards are preferable to process standards because they encourage efficiency and innovation. In addition, because performance standards entail measurable outcomes, they are potentially easier to compare or harmonize across borders than process standards. As a result, economists tend to recommend that performance standards play a larger role in national and international food safety systems. However, the practicalities of devising consistent, effective, enforceable performance standards for food safety may complicate the logic of economic theory.


W7.3 Perspectives on Pathogen Performance Standards. Whiting, R.C.; Food & Drug Administration

Abstract: Performance standards traditionally were developed for individual process operations, notably thermal pasteurization. The process parameters (time, temperature) and degree of stringency (how many logs of inactivation) were based on knowledge about microbial contamination and inactivation. However, subsequent experience (no new outbreaks) typically validated the adequacy of the standard. Development of the risk assessment tool has begun to allow performance standards be set to meet a public health criteria. Calculating from the maximum level of risk that would be tolerated, the food safety objective and performance criteria at different points in the food process can be determined. These calculations would include the inherent variation in the entire process from raw ingredients to the consumer and the uncertainties about the parameter values. This approach puts the focus on public health instead of on intermediate processing points and allows a processor more options for meeting the public health standard. The challenge is to quantify public health goals and collect the necessary data to make this a practicable approach.


W7.4 Discussant (Pathogen Performance Standards - an FSIS Perspective). Schwartz, P.S.; United States Department of Agriculture

Abstract: Pathogen performance standards play important roles in FSIS's overall food safety strategy. Performance standards serve as a measure of the success of food safety programs. They provide industry with objective, measurable standards that can be used to calibrate their HACCP systems. For FSIS, they serve as an important verification tool for HACCP. FSIS's experience in developing risk-based performance standards will be outlined. Factors to be considered in ensuring that performance standards are accurate and reliable measures of process control and the impact of data and knowledge gaps on the development of science-based strategies will be discussed.


Date added to January 2004
Pub. date from document: December 2003