Health Law

FSMA: The price of progress

By Marler Clark

Foodpoisonjournal.com has long championed the passage of the Food Safety Modernization Act, signed into law by President Obama in January.  It basically re-wrote an archaic regulatory scheme almost a century old, where the same demands, markets, and risks simply did not exist.  It made some of the impossibles--like having enough manpower, the authority to order recalls, and a risk-based approach to facility and foreign supplier inspection--totally possible.  But it contained a flaw.

The Got-No-Green Act is expensive to implement.  A projected $1.4 billion price tag over the next 5 years.  Mike Osterholm, Ph.D., MPH, with the University of Minnesota's Center for Infectious Disease Research and Policy, puts a little finer point on it in today's edition fo the New England Journal of Medicine:

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.'

If that is the rest of the story, it's bad news for food safety despite the monumental significance of the Food Safety Modernization Act. 

Full post as published by Food Poison Blog on February 23, 2011 (boomark / email).