The Government Accountability Office issued a report this week recommending that the U.S. Food and Drug Administration clarify its food recall process and do a better job communicating recalls and foodborne illness outbreaks to the public.
The report is the latest in a series of GAO reports calling for reforms. The government watchdog agency has listed the federal oversight of food safety as a “high-risk” area in need of “broad-based transformation” since 2007.
In a letter to congressional committees, GAO notes that FDA is charged with protecting public health, but must also be mindful of the impact food recalls and outbreaks have on the industry.
“When [foodborne illness] outbreaks are discovered, prompt responses from government and companies in the food distribution chain–the network of handlers, suppliers, and others involved in the production of food–can play a vital role in stopping the spread of illnesses and keeping the food supply safe; delays can result in more illnesses, as well as deaths,” reads the report. “If unwarranted, however, advisories about adulterated or misbranded food products and recalls of those products can trigger serious economic losses for the food industry and discourage the consumption of healthful food, such as fresh produce.”
As an example, GAO cites a 2008 Salmonella outbreak investigation gone awry. Based on initial evidence, FDA implicated tomatoes and issued a warning to consumers, but later the agency determined jalepeno and serrano peppers were the likely culprit. Consumers heeded the agency’s earlier warning and the tomato industry lost an estimated $145 million in revenue, according to GAO.
Lack of details regarding mandatory recalls
The report points out that FDA has not issued any sort of regulations or industry guidance on its new mandatory recall authority, which was granted by the Food Safety Modernization Act that President Obama signed into law last year. FDA has not publicly released important details about how the mandatory recall process works — and it’s not clear if the agency plans to do so in the future.
“FDA officials told us that they have not decided whether they will do so and that FSMA contains no such requirement,” says the report.
In their review of multiple agencies and states with mandatory recall authority, GAO found that such ordered recalls are “rare” and the majority of recalls are voluntary. (Alaska, New Mexico, South Carolina, and Texas all have mandatory recall authority for food products on the books). GAO found that since FSMA was enacted, FDA has not ordered any food recalls.
The report outlines FDA’s three step process for ordering food recalls (other than infant formula). First, the agency determines that there is evidence of a threat that meets a certain “standard of proof.” Second, FDA offers the company the opportunity to voluntarily recall the product before a mandatory recall is ordered. Third, the agency provides the company with the opportunity to challenge a recall decision.
GAO said that while FDA has so far not publicly provided details on its mandatory recall process, the agency did eventually provide GAO investigators with detailed interim internal procedures. “FDA officials have not, however, provided timelines on when they expect to make procedures publicly available,” according to the report.
“Unlike other agencies with the authority to order product recalls, FDA has not documented–in internal agency procedures or its regulations or guidance–how it weighs evidence to determine if a food recall is warranted and thereby if it has met the standard of proof necessary to order a food recall.”
The GAO report also sharply questions FDA’s data management system for keeping track of food recalls. For example, FDA officials gave inconsistent numbers when GAO asked for the number of ordered recalls in the agency’s history — both overall and within different agencies (including biologics, drugs, and devices).
GAO also found that as far back as 2004, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) was maintaining its own database outside of the FDA’s central recall database, the Recall Enterprise System. At that time, GAO investigators found inconsistencies between the two databases and recommended that FDA officials use only the central database.
In September 2008, GAO again found that CFSAN was maintaining a separate “unofficial database” for food recalls. In March 2012, GAO reported that CFSAN maintains 21 different database systems and recommended that FDA find a better way to manage data and information sharing.
“During our present review, we asked officials in the Center for Food Safety and Applied Nutrition why they continue to maintain a database separate from the Recall Enterprise System, and the officials responded that in certain cases, the center’s database was easier to search than the Recall Enterprise System.”
The investigators found that FDA has taken steps to better communicate food recalls to the public, but still has not adopted outside recommendations to develop “a comprehensive food recall communication policy.”
One of the biggest challenges to quickly and effectively communicating recalls to the public is balancing timeliness and accuracy.
“To make determinations about what information to provide and when to provide it, FDA officials told us that they use professional experience to look for a “tipping point,” that is, a time when evidence collected from a variety of sources–including epidemiological studies (which form and test hypotheses about an outbreak’s cause), field investigations, and laboratory results–is sufficient to allow the agency to provide consumers with information that will help them avoid unsafe food,” reads the report.
“FDA officials also stated that it is often only in hindsight, when all information is known, that they can confidently say when the right time was to provide what type of information.”
GAO also continues to recommend that FDA craft its own recall press releases — like the U.S. Department of Agriculture now does — instead of issuing company-drafted releases. According to GAO, in 2010, members of FDA’s own risk communication committee said that FDA’s reliance on industry releases could decrease public trust in FDA communications.
In 2008, USDA changed its policy and began collecting and posting information about which retail outlets received recalled USDA-regulated products, when those recalled products pose a serious health risk. GAO recommends that FDA provide similar retail information for consumers when FDA-regulated products are recalled.
“The agency neither agreed nor disagreed with GAO’s recommendations but cited ongoing agency actions that are to address most recommendations,” according to report.
For more on the GAO’s recommendations, including FDA’s comments, see the full report here.© Food Safety News