FDA criticized for slow recalls: How can feds improve food safety?
The FDA came under fire this week after an investigation found its food recall protocols inefficient and under-regulated.
When there a food safety issue is identified, how fast will the tainted product be recalled? That was a central question in an independent investigation of Food and Drug Administration's recall policy and procedure.
And in one case, involving nut butter authorities said was contaminated with salmonella, the answer was 165 days.
That incident was one of 30 that were investigated by the Department of Health and Human Services' Office of Inspector General. The results of the investigation were released in a report on Wednesday. Investigators concluded that the FDA "is not protecting American consumers from tainted and unsafe foods as quickly and thoroughly as it should."
The investigation revealed that the "FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls." Findings were based on 30 voluntary food recalls over a three-year period starting at the end of 2012.
While individual food producers are responsible for issuing voluntary recalls of tainted products, it is the responsibility of the FDA to identify food safety threats and alert producers when a recall needs to take place.
The speed and lack of procedure with which the FDA asked for and oversaw recalls of potentially contaminated foods was a central issue cited in the report. A lack of standard procedure and timelines meant that "consumers remained at risk ... several weeks after FDA was aware of a potentially hazardous food in the supply chain," the report said.
Rep. Rosa DeLauro (D) of Connecticut, who oversees food and drug safety for an FDA-focused house subcommittee, called the absence of procedure and recall timelines "mind boggling."
In a statement, Representative DeLauro cited a case of salmonella-tainted cucumbers that public health officials linked to 900 cases of illness, 191 hospitalizations, and six deaths. While the outbreak started in July, the producers did not recall product until September, she said.
"Delays like this one – and others found in the report – are completely unacceptable," said DeLauro.
FDA officials vehemently rejected the inspection's conclusions, calling them "unacceptable" in a blogpost released the following day on their website. The post, written in a measured, explanatory tone, points out that the report is based not on all cases of recall, but a select subset over that period.
In response to the inspection's findings, food safety officials, Stephen Ostroff and Howard Sklamberg maintained that recall "timeframes should be set, but they must be done on an individual basis rather than by setting arbitrary deadlines. The complexities surrounding recall events make it difficult for the FDA to establish a single timeline applicable to all situations."
The officials pointed to the danger of losing credibility with food producers if they become known for jumping to conclusions before the extent of potential food safety dangers can be accessed through thorough scientific evaluation. And, they said, overly hasty action "risks recalling the wrong product."
The officials pointed to several recent advances and future plans for improving how they respond to food safety issues. The FDA also recently created a task force for overseeing compliance, enforcement and field study.
Stricter requirements were already in motion for food recall, as per provisions in the 2011 Food Safety Modernization Act. This legislation will require all facilities to have a recall plan starting as early as September 2016 for some producers.
This report contains material from the Associated Press.