GAO: FDA Needs to Clarify Food Recall Process

.
Mike Rozembajgier
08-30-2012

With the passage of the Food Safety Modernization Act (FSMA) in 2011, the U.S. Food and Drug Administration (FDA) was given the authority to enforce food recalls in the event that a company failed to do so voluntarily.

While FDA has never ordered a product recall since the implementation of the FSMA, there is always a chance of the agency employing its new food recall authority in the future.

What exactly does this new mandatory recall authority mean for those within the food industry and consumers?

That remains unclear, according to a report released last month by the U.S. Government Accountability Office (GAO).

While FDA has internal procedures in place that describe each step in the process of ordering a food recall, it has not made such documents available to the public. The agency also has not issued regulations or industry guidance to clarify its ordered food recall process. With major foodborne illness outbreaks and food recalls continuing to draw public attention to the safety of the U.S. food supply, the GAO believes that taking such actions would lead to quicker responses from both the government and entities within the food distribution chain.

The U.S. Consumer Product Safety Commission (CPSC) and the National Highway Traffic Safety Administration (NHTSA), both of which also have the ability to mandate recalls, have developed this type of guidance in an effort to help consumers and those within their respective industries better understand their recall procedures and policies.

The GAO also identified a host of communications challenges FDA faces when it comes to effectively notifying the public about food recalls or foodborne illness outbreaks. These range from balancing technical accuracy with the timeliness of communications to coordinating messages with other federal regulatory agencies to meeting the needs of a diverse public audience.

While the report states that FDA has taken several steps to begin meeting such challenges, it has yet to fully adopt recommendations from the GAO and others to develop a comprehensive food recall communication policy.

Among the GAO’s recommendations for FDA to consider are to:

  • Document its process for ordering food recalls in publicly available procedures;
  • Identify and implement ways to improve information sharing among its databases that contain recall data;
  • Implement recommendations from the its risk communication committee to develop a policy for communications during emerging events; and
  • Implement recommendations from the GAO and other authorities to consult with the U.S. Department of Agriculture (USDA) on lessons learned in advising consumers about recalls to determine whether any of USDA’s practices may work for FDA.

What do you think about the FDA’s authority to mandate food recalls? Do you feel the GAO’s recommendations for FDA would lead to a decline in foodborne illness outbreaks and recall events? We welcome your comments below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

Leave a Reply

Get Ready Are You Ready Test Your Recall Test Your Recall