Is a simple cost-benefit analysis the right prism through which to view a preventive food safety program? Richard Williams’ interesting, but ultimately misguided, critique of the Food Safety Modernization Act (FSMA) strongly relies on cost-benefit worries to argue against four regulations the Food and Drug Administration (FDA) is proposing to implement the new law. But is he right on the facts?
FSMA replaces an antiquated food safety system that only reacted after people got sick or died with one that focuses on preventing foodborne illnesses. The obvious problem with the older system (people get sick and die) is what drove the food industry, public health officials, and consumer advocates to demand that Congress pass FSMA’s reforms in 2010. With 48 million foodborne illnesses, 128,000 hospitalizations, 3,000 deaths, and consumer losses estimated at as much as $77 billion annually, it is little wonder we wanted a food safety system that is better than the one we had.
Williams ignores the background and instead argues that FSMA is a solution in search of a problem. He asserts that the portion of consumer costs the regulations will reduce (e.g., the benefits) is not worth the effort to achieve prevention (e.g., the costs).
He begins by raising the bugaboo of “vastly” higher food prices. Even if his prediction comes true — something that would be hard to tease out of all of the factors that go into food pricing — it doesn’t carry much weight. Numerous surveys and economic studies demonstrate that consumers, when faced with a choice between price and safety, would opt to pay more for the safer food that FSMA will deliver. What consumers understand, but that Williams seems to miss, is that prevention is an unavoidable cost of doing business in the food industry.
The real threshold issue then is not the costs, as Williams avers, but the value of preventing avoidable foodborne illnesses and deaths. Once we pass that threshold, much of Williams’ remaining argument rests on mischaracterizations, cherry-picked facts, and mistaken assumptions.
Take his centerpiece example of the intentional adulteration rule. Much of the thinking about the threat of bioterrorism was summed up in a statement by former Health and Human Services Secretary Tommy Thompson: “I, for the life of me, cannot understand why the terrorists have not attacked our food supply, because it is so easy to do.” Williams argues that past is prologue and we don’t have to take preventive steps against the threat of terrorism. But one need look no further than the intentional adulteration of milk in China, which claimed the lives of six infants, hospitalized 54,000 babies, and sickened 300,000 babies overall, to recognize the enormous risk of being unprepared.
His attacks on three other FSMA rules also don’t hold up under scrutiny. He mistakenly identifies an increase in Vibrio vulnificus cases from raw shellfish as an example of how preventive food safety programs have failed. The Centers for Disease Control and Prevention report he relies on discloses that 70 percent of those “increased” cases are from wound infections, not foodborne causes. He also fails to account for the effect of better reporting after vibriosis became a nationally notifiable disease in 2007.
Williams assumes that past outbreaks are the only measure of risk in fresh produce. That completely ignores the fact that the identified multistate outbreaks represent only a tiny fraction of all foodborne illnesses. FSMA’s produce safety standards reflect a more comprehensive science-based risk assessment that goes beyond outbreak data to also consider the likelihood of contamination and the capacity of a contaminated food to support pathogen survival and growth. Even if his premise were correct, a review of his underlying report finds that he has failed to acknowledge outbreaks associated with contaminated avocados (2001), strawberries (1996, 2000, 2003, 2005, 2007 and 2011), grapes (2010), mangos (1999), and others that are listed in the “Outbreak Alert!” database maintained by the Center for Science in the Public Interest.
Problems with Williams’ article proliferate the more you delve into his underlying report. At one point, for example, he argues against a 2001 regulation that applied HACCP (a preventive-control program) to the juice industry. Yet he supports mandatory pasteurization of juice, which is the kind of “command-and-control” strategy he decries.
The pejorative claim that FSMA is itself a command-and-control structure is also questionable. FSMA’s preventive-controls rules, like HACCP, are flexible and actually remove regulators from decisions on how to produce a safe product. The trade-off is that manufacturers have to have food safety plans and keep records to demonstrate they have chosen a sound approach based on likely hazards that they identify. That combination lets each manufacturer plan how best to carry out its responsibility to produce safe food while giving regulators information to confirm that the plan is being followed.
FSMA rightly discards the kind of 19th-century laissez faire attitude toward food safety that Williams prefers. Under his concept of a “better system,” FDA and food safety inspections would be replaced by a courtroom and a judge on the premise that it is more economical for people to get sick and then sue than to ask food producers to do the right thing and make safer food. That system has been tried, and it just doesn’t work.
Williams’ faith in the new information age assumes that everyone has perfect information and will act on it, which they don’t. Few foodborne illnesses are diagnosed and fewer reported, epidemiology is difficult to do and often underfunded, and effective traceability is a work in progress at best. Williams acknowledges that “millions of food safety cases … plague Americans annually” and hopes information-driven incentives might make a dent. But failures within that system in gathering and reporting information provide the industry with little feedback to produce safer food. Moreover, individual food producers may not bear the costs of problems they create because foodborne illness costs are shared by consumers and other segments of the economy. As a result, individual food producers are likely to underinvest in food safety, according to USDA’s Economic Research Service.
While many food manufacturers and farmers willingly accept the costs of producing safe food as a cost of doing business, there are others who don’t. The Peanut Corporation of America (PCA) outbreak is the poster child for what happens when incentives fail. That company’s competitors spent millions of dollars to protect their brands and suffered millions more in lost sales because of that outbreak. Because PCA mainly supplied other food producers, those brands suffered enormous losses from bad publicity as the company conducted costly recalls. But nowhere were the costs more overwhelming than for peanut farmers who saw up to $1 billion in losses from that one event. Those kinds of costs are exactly why large parts of the food industry support FSMA and its preventive approach to food safety.
