In the midst of food prices that are already on the rise, the U.S. Food and Drug Administration’s Food Safety Modernization Act (FSMA) will vastly increase costs, but it’s not likely to change food safety nor will it modernize our approach to food safety. In a new research paper, I examine four of the biggest of the new regulations (ultimately, there may be as many as 50) and find no evidence that they will have much effect on the safety of manufactured food, produce, imported food or animal food. And, despite the name of the law, the approach taken with all of these rules is not modern. Instead, it is trying to tell manufacturers how to produce food and inspect producers for compliance — an approach that dates back to the 1870s in the United States. In the modern information age, there is a much better way. There are two essential items that should be present for a regulation to have an impact: First, there must be a problem to solve, and second, there must be some measure of effectiveness at solving that problem. Ideally, there is not an excessive cost attached to the solution. By FDA’s own analysis, each of the four regulations examined in my recent study fail in one of the two categories. An example of the first issue — failure to identify a large, ongoing problem to be solved — is best illustrated by a proposed rule on “intentional adulteration.” Put simply, this is a rule to prevent terrorists from poisoning food. FDA admits there has been no intentional adulteration and that it has no idea what food companies have been doing since 9/11 to protect their plants. In other words, they have absolutely no idea whether there is a problem to fix with this large and expensive solution. There is also scant evidence to suggest a large, systemic problem with packaged food; nevertheless, FDA does have a large and expensive rule. Using elements of a regulatory cost calculator, the solution to this nonexistent problem will cost $18 billion, according to industry estimates. While there have been a few highly publicized outbreaks traced back to packaged food, FDA notes that most food safety problems occur in restaurants, other retail establishments or homes.1 These problems are not covered by the current rule. Then there is the second problem, when there is no effective solution presented. This is surely the case with FDA’s rule for fresh produce. Fresh produce from farms certainly can cause foodborne disease, but FDA has focused on forcing Hazard Analysis Critical Control Points (HACCP), created for manufactured food, to fit produce. Unfortunately, this method has been tried by FDA before for products that do not have a control step between harvest and mouth, e.g., raw shellfish, without success. If there is no control point, HACCP is useless. In some cases, Congress allowed discretion to reduce the scope of these rules, but FDA has chosen not to exercise discretion, proposing the biggest possible rules. For animal foods, FDA has evidence that contact with pet foods cause illness in humans, but no evidence that the same is true for farm animal food. Nevertheless, they proposed regulating both pet and farm animal feed with the same controls. For fresh produce, they have evidence associated with outbreaks for some fruits and vegetables, but note that others have no such associated outbreaks. Incredibly, they have adopted a philosophy that, because something could happen with the produce that has never been associated with an outbreak, they should be covered. It doesn’t take much of an imagination to expand that philosophy to justifying the regulation of everything on the planet. The biggest problem, however, comes with the entire approach, command-and-control regulation and inspection. It’s old, it’s outdated, and it’s not likely to work. FDA will never have the knowledge to tell every type of domestic and foreign producer, warehouse, transporter and retailer what the best way is to keep their products safe. Nor will they ever have enough inspectors to cover them all in a timely fashion, even though they will continue to press American taxpayers for more resources. What they do have is a new information age where — if/when producers make mistakes — those mistakes can often be traced back to the producers, and that information is immediately spread to millions of consumers. That creates an incentive for producers to mitigate lawsuits, recalls and diminished sales. FDA can help to determine what caused the problem, allowing everyone who might experience a similar problem to change their own practices or contracts with suppliers. In other words, we now have better trace-back, problem identification and communication abilities to create incentives. With those incentives will come both more due diligence and creation of more technologies, such as pasteurization, which historically have made the biggest difference in food safety. Those incentives are much more powerful than the old regulatory approaches and, if embraced, we may finally start to make a dent in the millions of food safety cases that plague Americans annually.
1FSMA Supplemental Notice of Proposed Rulemaking for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, Docket No. FD-2011-N-0920, Preliminary Regulatory Impact Analysis, p. 6 (To sign up for a free subscription to Food Safety News, click here.)