GAO Report on FDAWith the large number of recent foodborne illness outbreaks in the US, the question of how safe the US food supply is pops up on a regular basis. Prompt responses from the appropriate government agencies can play a role in slowing and/or stopping the spread of foodborne illnesses and death, but unfounded recalls cost money and do damage to brands.

In response to congressional direction regarding the FDA Food Safety Modernization Act (FSMA), the Government Accountability Office (GAO) was tasked with three areas for further research:

1. Examine government entities having the authority to order product recalls and how FDA implements its authority

2. Examine the challenges FDA faces, if any, in advising the public about food recalls or outbreaks of foodborne illness, and how the agency has addressed these challenges

3. Identify mechanisms that may compensate the food industry for erroneously ordered food recalls or erroneous food-related advisories.

GAO reviewed documents from FDA and other government entities and looked at FDA data. GAO also interviewed stakeholders from the food industry and consumer organizations, government officials and experts in food safety and food law. The conclusions were compiled in a report to congressional committees, entitled FDA’s Food Advisory and Recall Process Needs Strengthening.

Several government entities, including federal agencies such as the FDA and the Consumer Product Safety Commission, and some states such as Texas, have the authority to order product recalls. Generally, FDA is supposed to follow the same process for implementing its food recall authority that other federal agencies use to order recalls of other products. These include:

1. Determining that available evidence of a threat meets a standard of proof to order a recall

2. Offering a company the opportunity to voluntarily recall a product before a recall order is issued

3. Providing the company with an opportunity to challenge a recall decision.

FDA has internal procedures describing the steps it will take to order a food recall, although these procedures are not yet public, and the agency has not issued regulations or industry guidance to clarify its ordered food recall process, according to GAO.

FDA faces a number of communication challenges when advising the public about food recalls or outbreaks of foodborne illness, ranging from balancing technical accuracy with timeliness of communications to coordinating messages with other agencies to meeting the needs of diverse public audiences. The agency has taken steps to begin meeting these challenges but has yet to fully address recommendations from GAO and others to fashion a comprehensive food recall communication policy and related implementation plans.

Various government mechanisms—each with advantages and disadvantages described by individuals GAO interviewed—might be available to compensate food producers in case of an erroneously ordered food recall or erroneous food-related advisory, but GAO found no examples of such mechanisms that have been used to provide compensation. The mechanisms include a dedicated federal government program or federal government-subsidized insurance, among others.

GAO recommends, among other things, that FDA issue regulations or industry guidance to clarify its ordered food recall process and implement recommendations from others to address FDA communication challenges in advising the public about food recalls and outbreaks. The agency neither agreed nor disagreed with GAO’s recommendations but cited ongoing agency actions that are to address most recommendations.

For more information on the GAO report, visit GAO’s website. You can also download the complete 61-page report.