Michael T. Osterholm, Ph.D., M.P.H., (a.k.a., the god of food safety epidemiology) wrote today in the New England Journal of Medicine – “Foodborne Disease in 2011 — The Rest of the Story” today. Here are the highlights:
So will the Food Safety Modernization Act result in immediate improvements in food safety? The legislation brings long overdue modernization to the FDA’s food-safety activities. It gives the FDA broader authority to regulate food facilities, including authorization to inspect records related to food. It “requires each owner, operator, or agent in charge of a [nonexempt] food facility to identify and implement preventive controls to significantly minimize or prevent hazards that could affect food manufactured, processed, packed, or held by [that] facility.” It also requires the FDA “to issue guidance documents to reduce the risk from the most significant foodborne contaminants” and to “establish minimum standards for the safe production and harvesting of fruits and vegetables based on known safety risks.” It further requires the FDA “to allocate resources to inspect facilities and imported food according to the known safety risks of the facilities or food; and [to] establish a product tracing system to track and trace food that is in the United States or offered for import into the United States.” It gives the FDA authority to order a recall of a food when it is contaminated or implicated in an outbreak. Finally, it “requires U.S. importers to perform risk-based foreign supplier verification activities to verify that imported food is produced in compliance with applicable requirements related to hazard analysis and standards for produce safety and is not adulterated or misbranded.”
Although all these new forms of authority will substantially enhance the FDA’s ability to prevent foodborne disease and respond more effectively when an outbreak occurs, the new law has a major shortcoming: dollars. There was no appropriation approved by the Congress for the act or authorization in the bill for the FDA to assess fees on the companies that it inspects. The Congressional Budget Office estimated that implementing this legislation would require $1.4 billion between 2011 and 2015.5 Though the bill authorizes the FDA to collect fees when a facility requires reinspection and a recall fee for mandatory recalls, these fees are expected to provide minimal resources. In short, the actual effect of this important law will at best be extremely limited if Congress and the administration don’t appropriate and sign additional legislation providing the necessary funds to carry out its mandates. Recent reports in the media calling this act “historic legislation” must be tempered by the reality that without the necessary resources, requiring the FDA to carry out the law’s required activities will be like trying to get blood out of a rock. And in the end, food safety in the United States cannot be expected to improve in more than an incremental manner.
As Paul Harvey would have said, “That’s the rest of the story.”
I would simply say – “Show me the Money!” This article (10.1056/NEJMp1010907) was published on February 23, 2011, at NEJM.org.
Full disclosure – Mike and I tend to email each other at hours between midnight and 4:00 AM; sometimes we do not agree on policy; and, his son worked for me for the Summer of 2009. Also, we have talked about going fly fishing, but we have never connected.