The FSMA greatly increases FDA responsibilities for food safety and mandates more frequent inspections. The Act directs FDA to use risk-based prioritization to target efforts toward the most serious foodborne health hazards. FDA is expecting to look at factors such as firms’ and importing countries’ past food safety records, indicators of a firm’s financial stability, the inherent riskiness of foods, and most critically, the relative contribution of different foods to the total burden of foodborne illness in the United States.

Comparing the illness burden of different pathogens and food sources is not easy. CDC can only identify the responsible pathogen in 20 percent of foodborne illness cases overall, though CDC can identify the pathogen for 44 percent of cases that send people to the hospital or result in death. And, cases with different outcomes are not directly comparable. Some pathogens cause many mild illnesses. Others cause fewer illnesses but fatal outcomes or serious chronic conditions.

Health economists have developed two aggregate measures to facilitate comparison of health burden across diverse diseases: monetary measures and a measure called a quality-adjusted life year (QALY). The cost of illness—typically measured as treatment costs plus the value of lost time from work and individuals’ willingness to pay to reduce risk of death—is usually used as a monetary metric in food safety policy analysis, even though it underestimates the burden of illness.

The QALY approach allows patients, medical experts, or a sample of the general population to rank the relative impact of illnesses on the quality of life. This measure was developed to help health care analysts and doctors evaluate the cost effectiveness of alternative medical treatments. The Office of Management and Budget recently allowed the QALY approach to be used in regulatory analysis.

Researchers at ERS conducted some of the earliest studies of the economic costs of foodborne illness. ERS’s online Foodborne Illness Cost Calculator provides a transparent framework for estimating the cost associated with foodborne illness due to Salmonella and STEC:O157 (formerly E.coli: O157:H7). This work is ongoing. As patterns of disease, detection, and treatment change, the public health and economic burden also changes.

Building on earlier ERS cost-of-illness models, a team of researchers from the University of Florida and ERS recently estimated that 14 pathogens impose a little over $14 billion annually in cost of illness and cause a loss of about 61,000 QALYs each year. These pathogens account for over 95 percent of the foodborne illnesses, hospitalizations, and deaths CDC can tie to specific pathogens. This study also estimates the share of foodborne illnesses attributable to consumption of 10 broad food categories such as beef, poultry, or produce.

The results suggest that it should be possible to target public and private food safety control efforts to reduce illnesses more effectively. Just 5 pathogens account for 90 percent of the cost of foodborne illness from these 14 pathogens. Ten food/pathogen combinations are responsible for almost 60 percent of the public health burden of the 14 pathogens, whether measured by cost of illness or QALYs.

The FSMA is a major change in FDA legal authority aimed at bringing FDA’s food safety programs more in line with recognized food safety management principles. But it is not a major change in the scientific consensus about the direction food safety management needs to move. Many of the policies FDA will be implementing—like prioritizing risk and encouraging producer initiative—are already in use elsewhere. Research by ERS and other institutions on the design and impacts of past regulatory efforts can inform policymakers as they move forward.