Food Safety:
FDA's Food Advisory and Recall Process Needs Strengthening
GAO-12-589: Published: Jul 26, 2012. Publicly Released: Jul 26, 2012.
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What GAO Found
Several government entities, including federal agencies such as the Food and Drug Administration (FDA) and the Consumer Product Safety Commission, and some states such as Texas, have the authority to order product recalls. Generally, FDA is to follow the same process for implementing its food recall authority as other federal agencies use to order recalls of other products, including (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, and (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. 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. Specifically, FDA has not (1) adopted a recommendation from its Advisory Committee on Risk Communication to create a policy for emerging events to more comprehensively address several of its communication challenges; (2) created plans recommended by the Institute of Medicine and National Research Council to help address coordination challenges surrounding its communications; or (3) fully implemented a recommendation from GAOs past work to determine jointly with the Department of Agriculture what, if any, additional approaches are needed for advising consumers about recalls. When GAO asked FDA officials how they had responded to these recommendations, they provided information on some actions they are taking. However, FDAs stated actions do not fully implement these recommendations. As a result of not implementing them, FDA may be missing opportunities to more comprehensively address its communications challenges. Various government mechanismseach with advantages and disadvantages described by individuals GAO interviewedmight be available to compensate food producers in case of an erroneously ordered food recall or erroneous foodrelated 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. For example, individuals GAO interviewed said that a potential advantage of a dedicated program would be assurance to industry that a mechanism would be available, but a potential disadvantage may be that in lean budget times, funding for such a program may be difficult to obtain. Individuals GAO interviewed identified several factors that may come into play when deciding to establish any compensation mechanism, such as defining what constitutes an error or mitigating the potential consequences.
Why GAO Did This Study
Numerous outbreaks of foodborne illnesses in past years continue to draw public attention to the safety of the nations food supply. Prompt responses from government entities and the food industry can play a vital role in stopping the spread of illnesses and deaths, but unwarranted recalls of food products can trigger serious economic losses for the food industry. In response to congressional direction regarding the FDA Food Safety Modernization Act, GAO (1) examined government entities having the authority to order product recalls and how FDA implements its authority; (2) examined 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; and (3) identified 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 FDA data and interviewed stakeholders from the food industry and consumer organizations, government officials, and experts in food safety or food law.
What GAO Recommends
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 GAOs recommendations but cited ongoing agency actions that are to address most recommendations.
For more information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov.
Recommendations for Executive Action
Status: Closed - Implemented
Comments: In October 2013, FDA published updated recall procedures in its Regulatory Procedures Manual, which is publicly available online. Those updates include specific information on mandatory food recalls.
Recommendation: To strengthen FDA's process for ordering recalls, the Secretary of Health and Human Services should direct the Commissioner of FDA to document FDA's process for ordering food recalls in publicly available procedures.
Agency Affected: Department of Health and Human Services
Status: Closed - Implemented
Comments: In November 2018, FDA published final guidance for industry on mandatory food recalls. This guidance includes information on (1) the process FDA will follow for mandatory food recalls, (2) the evidence or circumstances the agency may consider when deciding whether to move forward with a mandatory recall, and (3) examples or situations when the FDA would deem a food product to cause serious adverse health consequences or death. We therefore have closed this recommendation as implemented.
Recommendation: To strengthen FDA's process for ordering recalls, the Secretary of Health and Human Services should direct the Commissioner of FDA to document FDA's process for ordering food recalls in regulations or industry guidance to include information on how the agency will weigh evidence on whether a recall is necessary.
Agency Affected: Department of Health and Human Services
Status: Closed - Implemented
Comments: At the beginning of fiscal year 2016, FDA finalized definitions for categories of ordered recalls in its central recall database.
Recommendation: To strengthen FDA's process for ordering recalls, the Secretary of Health and Human Services should direct the Commissioner of FDA to document definitions for categories of ordered recalls in the agency's central recall database.
Agency Affected: Department of Health and Human Services
Status: Closed - Implemented
Comments: FDA has improved information sharing between its databases that contain recall data. For example, FDA's enhanced its central recall database to allow individual centers to read and write data directly to the central database.
Recommendation: To strengthen FDA's process for ordering recalls, the Secretary of Health and Human Services should direct the Commissioner of FDA to identify and implement ways to improve information sharing among its databases that contain recall data.
Agency Affected: Department of Health and Human Services
Status: Closed - Not Implemented
Comments: FDA stated that it maintains Standard Operating Procedures (SOP), including SOPs for moving press and web communications through an internal clearance process before being released. However, such SOPs are one of many areas that a comprehensive communications policy would cover, and we have not received information on additional policy elements.
Recommendation: To address FDA's communication challenges in advising the public about food recalls and outbreaks, the Secretary of Health and Human Services should direct the Commissioner of FDA to implement recommendations from FDA's risk communication committee to develop a policy for communications during emerging events.
Agency Affected: Department of Health and Human Services
Status: Closed - Not Implemented
Comments: FDA stated that through its Coordinated Outbreak Response Network, it coordinates public messaging with CDC, particularly through Standard Operating Procedures (SOP), including SOPs for moving press and web communications through an internal clearance process before being released. However, such SOPs are one of many areas covered by a coordinated plan for crisis communications, and we have not received information on any other areas of coordination.
Recommendation: To address FDA's communication challenges in advising the public about food recalls and outbreaks, the Secretary of Health and Human Services should direct the Commissioner of FDA to implement recommendations from the Institute of Medicine and National Research Council to develop, in conjunction with other federal agencies, a coordinated plan for crisis communications.
Agency Affected: Department of Health and Human Services
Status: Closed - Not Implemented
Comments: FDA officials told us that they published a draft regulation on its Reportable Food Registry aimed at improving the display of recall information at the retail level. However, this regulation is not yet final and it is unclear whether FDA consulted with USDA when drafting the regulation. FDA officials also told us that they continue to exchange information on foodborne outbreaks and recalls with USDA in an effort to identify and implement ways to improve information sharing, but that there are both policy and procedural differences between FDA and USDA. We recognize these differences, which is why we did not suggest specific USDA methods that FDA might consider. To date, FDA has not provided evidence that in their ongoing information exchange, they have consulted with USDA on lessons learned in advising consumers about recalls.
Recommendation: To address FDA's communication challenges in advising the public about food recalls and outbreaks, the Secretary of Health and Human Services should direct the Commissioner of FDA to implement recommendations following from our prior work and others' input to consult with USDA on lessons learned in advising consumers about recalls to determine whether any of United States Department of Agriculture's (USDA) practices may be feasible at FDA, as consistent with applicable law.
Agency Affected: Department of Health and Human Services
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