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From: The eUpdate, 8.14.2012

GAO Report Attacks FDA Reliability on Food Recalls

Expert suggests criticism unjustified

The FDA’s food recall process leaves significant room for improvement, according to a critical report released in late July by the GAO. The report, entitled “FDA’s Food Advisory and Recall Process Needs Strengthening,” makes several specific recommendations for the FDA, suggesting that it:

  • Publish a document describing the steps it takes to order a food recall, a process that is currently internal;
  • Document its process for ordering food recalls in regulations or guidance;
  • Define categories of ordered recalls in the FDA’s central recall database; and
  • Determine and implement ways to improve the sharing of information among databases that contain recall information.

The FSMA ordered the GAO to “report on issues associated with the FDA’s new ability to order food recalls.” But there’s one hitch: The regulations that will govern the FDA’s implementation of the FSMA are still languishing at the Office of Management and Budget—more than six months after they should have begun to take effect.

Robert Buchanan, PhD, who directs the Center for Food Safety and Security at the University of Maryland in College Park, thinks the GAO has jumped the gun with its criticisms.

“GAO takes FDA to task for not having made public their criteria and their guidance for recalls, while they should know that all of those requirements associated with FSMA will be held off until the regulations go through OMB,” he pointed out. “The report implies that the FDA isn’t doing their job, while the fact is that they have a whole bunch of things stuck at OMB. The efficiency of things like mandatory recalls will depend on traceback, which now is under review at OMB.”

Dr. Buchanan added that the FDA is not the sole authority in making recall decisions. “The speed and accuracy with which the FDA can conduct an investigation is dependent on how fast they can get the epidemiological data, how tight it is, and how quickly they can do a recall,” he said. “It’s not the call of the FDA alone. It’s done in conjunction with the CDC as well as the states impacted, and the error is always on the side of public health. Imagine the fallout if they didn’t take that approach? There are some unrealistic expectations here as to how well this is going to work.”

Dr. Buchanan is also skeptical of the report’s suggestions about ways to compensate the food industry in the event of erroneously ordered recalls. “It seems unlikely that the FDA could actually be expected to make restitution to the food companies if they make a mistake in their epidemiology,” he observed. “They barely have the budget to afford what they’re doing now.”

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