Analysis Contends FSMA Not Cost Effective

An analysis of the Food Safety Modernization Act (FSMA) conducted by the Mercatus Center at George Mason University contends that the benefits of the “four most burdensome regulations” in FSMA will most likely not outweigh their costs. “In some cases the rules are unnecessary; in others they are likely to be ineffective,” the report states.

The author of the analysis, Richard Williams, PhD, is a senior research fellow and vice president of policy research at the Mercatus Center. “As the rules stand now, they are simply too expensive for the return on food safety that we are getting,” he says, adding that he anticipates meeting with the Senate Steering Committee and the House Energy and Commerce Committee about the report.

Dr. Williams’ report focuses specifically on four of the proposed regulations: the human food rule, the animal feed rule, the produce rule, and the intentional adulteration rule. According to Dr. Williams, a former director for social sciences at the FDA’s Center for Food Safety and Applied Nutrition, “there is very little evidence of the significant food safety problems purportedly addressed by some of the regulation and, for others, there is insufficient evidence the rules will be effective at reducing foodborne risk.”

Patricia Wester, a food safety consultant and president of PA Wester Consulting in Gainesville, Fla., says that the FSMA rules that impact food safety are designed to close gaps in the current regulatory requirements and are focused on the manufacturers’ responsibility for producing safe products. “FSMA simply takes HACCP [Hazard Analysis and Critical Control Points] one step further and requires industry to document more thoroughly what they should already be doing.”

“These regulations have tremendous support across the industry,” she says. “[Dr. Williams] used data selectively to support his stance. His stance appears to be no regulations are good regulations if they cost any money, and then only if enough people get sick and or die to make it cost effective.”

David Acheson, MD, founder and CEO of The Acheson Group and a former chief medical officer at the FDA Center for Food Safety and Applied Nutrition, says he also disagrees with the report’s conclusions. Foodborne illness outbreaks demonstrate “the need to set an industry standard that is a regulatory baseline, and big sectors of the food industry support it. FSMA sets a baseline that needs to be there. This is not a short-term solution. Many other countries in the world have set baseline standards for food production, and as a country we need to do that.

“I’m an advocate of FSMA,” continues Dr. Acheson. “It needs to be done right and there are aspects of it that are not perfect, but it’s an evolution.”