FDA to address lag between food recall and removal

Recent high-profile e-coli outbreaks and a damning government investigation have spurred renewed efforts to speed up Food and Drug Administration recalls of unsafe food.

“The food recall process [is] too slow and unduly exposes countless Americans to food that can make them sick – or even kill them,” Sen. Chuck Schumer, D-N.Y., said in a statement July 31.l

The lawmaker’s criticism followed an early alert report from the Health and Human Service Department that said its ongoing audit of the FDA’s recall procedures found the agency lacks “an efficient and effective food recall initiation process.”

Under a five-year-old law, the FDA must give companies the opportunity to voluntarily recall food as soon as the agency learns of a safety problem, but there is no mandatory deadline by which companies must respond. The FDA then would require the recall, but that has only happened twice since the law was enacted.

“We found that FDA’s policies and procedures did not instruct its recall staff to prescribe to the firms a time and a manner in which to initiate the voluntary recall,” the inspector general’s report stated. “We also found that FDA did not have policies and procedures to ensure that firms initiated voluntary food recalls promptly.”

In all 30 recall cases it randomly chose to investigate, the inspector general’s office said the FDA failed to give a timeline for taking the contaminated foods off the market.

“As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain,” the report concluded.

The FDA noted that during the three-year period reviewed by HHS, the agency “oversaw thousands of food recalls, with an average time for recall initiation of less than a week.” It did acknowledge that the “small number” of recalls that fell outside the average timeline were “unacceptable.” Officials noted that the agency recently established a “rapid-response team” to address recall timeline concerns.

Thomas Gremillion, director of food policy at the nonprofit consortium Consumer Federation of America, said the report identified an important problem in the relationship between the FDA and the companies it regulates.

“Companies need some more direction on how they need to respond to these voluntary recall requests,” Gremillion said.

The report pointed out one instance in which it took 165 days from the time the FDA discovered salmonella in a nut butter and issued a recall request for the company to act.

“That’s symptomatic of too much discretion being put in a company’s hands, who have a conflict of interest, at the end of the day,” Gremillion said. “Recalls are expensive and [companies] have to be concerned about their bottom line.”

Lawmakers and food safety advocates have proposed the FDA become an independent agency to eliminate bureaucracy that may slow the pace of policy enforcement. The FDA is part of the Department of Health and Human Services, but is also overseen by the Department of Agriculture.

In June six former FDA commissioners agreed the FDA should become independent.

Dr. Andrew von Eschenbach, FDA commissioner under Presidents George W. Bush and Barack Obama, said the agency is “trapped in a structural problem,” and advocated for the FDA to have a “cabinet-level presence.”

David Kessler, who served as commissioner under Bush and President Bill Clinton, highlighted the bottleneck that occurs when as many as 150 people between the commissioner and the president “think they are [the commissioner’s] boss.”

“The amount of micromanagement of the agency has gotten to the point where it needs to be addressed,” Kessler said.

In January of last year Sen. Dick Durbin, D-Ill., and Rep. Rosa DeLauro, D-Conn., introduced a bill, versions of which they’ve proposed four times since 1999, that would consolidate the food safety authorities of multiple agencies into one single agency.

Gremillion’s organization supports the Durbin-DeLauro bill, but sees it as a “pie-in-the-sky” ideal that most likely won’t be passed because of “vested interests.” He pointed in particular to the USDA’s mission to promote the very same foods it regulates.

“Politically it doesn’t seem really likely now, but if there are outbreaks or scares that get people concerned about the safety of the food supply,” he said, “some changes that seemed politically unfeasible not too long ago may become much more palatable.