GAO Report Criticizes FDA Food Recall Process
The Government Accountability Office (GAO) has issued a July 26, 2012, report criticizing the Food and Drug Administration’s (FDA’s) efforts to implement a comprehensive food advisory and recall process. As directed by the FDA Food Safety Modernization Act, GAO reportedly assessed the agency’s ability to order recalls and effectively inform consumers and retailers about food safety issues, concluding that although FDA has established internal procedures “describing the steps it will take to order a food recall … these procedures are not yet public and the agency has not issued regulations or industry guidance to clarify its ordered food recall process.”
In particular, the report faults FDA for failing to fashion “a comprehensive
food recall communication policy and related implementation plans.” Noting
that recent foodborne illness outbreaks have drawn national attention to
food supply safety issues, GAO argues that FDA has not yet drafted measures
to better manage its communication challenges or worked with the U.S.
Department of Agriculture (USDA) and other federal agencies to determine
“what, if any, additional approaches are needed for advising consumers about
recalls.” The report also calls FDA’s data on ordered recalls of nonfood products
“unreliable,” raising questions about whether similar data on ordered food
recalls “can be relied upon to report accurate information to Congress and the
public.”
“Without this information, the agency cannot ensure that it applies practices
uniformly or consistently or that it gives clear information to the food industry
or to consumers and the public,” states the report, which asks whether various
government mechanisms, such as subsidized insurance, should be made
available “to compensate food producers in case of an erroneously ordered
food recall or erroneous food-related advisory.”
In the interest of greater transparency, GAO also urges FDA to clarify its food
recall process. To these ends, the report recommends that the Department of
Health and Human Services direct FDA to (i) document the agency’s process
for ordering food recalls in publicly available procedures, regulations or
industry guidance that “include information on how the agency will weigh
evidence on whether a recall is necessary”; (ii) “improve information sharing
among its databases that contain recall data”; (iii) “develop, in conjunction
with other federal agencies, a coordinated plan for crisis communications”; (iv)
“consult with USDA on lessons learned in advising consumers about recalls to
determine whether any of [USDA’s] practices may be feasible at FDA”; and (v)
“develop a policy for communications during emerging events.”
“When GAO asked FDA officials how they had responded to these recommendations, they provided information on some actions they are taking. However, FDA’s stated actions do not fully implement these recommendations,” concludes the report, citing earlier assessments of the agency’s food recall capabilities. “As a result of not implementing them, FDA may be missing opportunities to more comprehensively address its communications challenges.”
