Scathing government report questions FDA food recall data reliability

The US Government Accountability Office (GAO) made these comments in its July 2012 report to Congres…

Report author Lisa Shames, director, natural resources and environment at the GAO, wrote that the Food Safety Modernisation Act (FSMA), signed into law in January 2011, gave the FDA a new oversight tool to ensure food safety.

Recall effectiveness unclear

Namely, the FDA now the authority to order companies to recall foods other than infant formula that it determined were adulterated or unsafe, and has drawn-up interim procedures to order recalls.

But Shames wrote: “It remains unclear, however, how effective the agency will be in fully implementing this new authority.”

She noted that (1) The FDA’s internal procedures were not public (2) The agency had not issued regulations or industry guidance clarifying these procedures, including how it weighed evidence to assess whether a recall was necessary.

“FDA officials told us the agency had not decided whether to provide such information,” Shames said.

However, she added that, without this information, the FDA could not ensure it applied practices uniformly or consistently, or that it gave clear information to the food industry or consumers.

In this respect, the FDA needed to balance technical accuracy with timeliness of communications, and co-ordinate messages with other agencies to meet diverse audience needs, Shames noted.

More damningly, she wrote that the FDA’s data on ordered recalls of non-food products appeared to be unreliable, due to use of undocumented definitions to group recall categories, and the fact that database recall data was not fully shared.

Shames wrote: “Given these issues, it is not clear whether or to what extent the agency’s data on ordered food recalls can be relied upon to report accurate information to Congress and the public.”

Lacks crisis communications plan

The FDA had also failed to adopt a recommendation from its own risk communication committee that it develop a communications policy to address emerging events, and a separate recommendation that it develop a coordinated crisis communications plan, Shames added.

“The FDA is not clarifying for those outside the agency what to expect from FDA communications, and the agency continues to risk providing information on foodborne illnesses that conflicts with the information provided by other agencies or confuses consumers,” she wrote.

Moreover, the FDA had missed an opportunity to work with the USDA (US Department of Agriculture) to identify additional approaches needed to advise consumers of recalls, Shames wrote.

Reacting to the report, the Department of Health and Human Services (which oversees the FDA) said that it (in Shame’s words) “neither agreed nor disagreed”with the report recommendations.

Nonetheless, Shames added that the FDA had also replied with an action plan explaining how it would address most of the issues raised.