Critical Audit on Food-Recall Failures Riles Up House

WASHINGTON (CN) – Federal health officials faced the wrath of House lawmakers Friday on the heels of an audit that says food companies waited an average of 57 days to act on reports of tainted food.

Rep. Greg Walden, R-Ore., delivers remarks at a Jan. 19, 2017, hearing at the House.

While a two-month delay was the average among the 30 recalls between 2012 and 2015 examined in a December 2017 inspector general report, one company warned by the Food and Drug Administration about a supplement product waited 303 days to initiate a recall.

“I take this issue very personally,” said Representative Greg Walden, kicking off a 90-minute hearing Friday at the House Subcommittee on Oversight and Investigations.

An Oregon Republican, Walden held up for the audience a large snack container sealed with yellow “caution” tape tied in a bow on top.

Back in 2009, Walden had a 3-year-old constituent named Jake Hurley who got salmonella after eating contaminated peanut butter crackers manufactured by the now-defunct Peanut Corp. of America.

When the salmonella outbreak sickened more than 700 people across the country and killed nine, Walden wielded the same container in a subcommittee hearing that year.

Peanut Corp. CEO Stewart Parnell is now serving a 28-year prison sentence for fraud, conspiracy and introducing adulterated food into interstate commerce, but Walden recalled Friday how the executive refused at the 2009 hearing to sample some of the contaminated peanuts.

“I asked him whether he was willing to take the lid off and eat any of these products now, since he was so cavalier about turning it loose on little kids like Jake to eat,” Walden said, referring to Jacob. “He refused of course, citing his Fifth Amendment rights.”

A House committee swears in witnesses to testify at a Jan. 19, 2017, hearing on Food and Drug Administration oversight of product recalls.

Congress enacted a 2011 law in the wake of the salmonella outbreak that empowers the FDA to mandate recalls.

It has been invoked only twice by the FDA, said Douglas Stearn, the acting deputy director for regulatory affairs at the Center for Food Safety and Applied Nutrition.

During a question-and-answer segment of Friday’s hearing, Stearn said that  the FDA works collaboratively with companies during recalls, and that food companies are generally cooperative. This is key, Stearn added, since recalls happen faster if companies do them voluntarily.

In the most serious cases, characterized as Class I recalls, Stearn said the FDA will issue its own press release about a recall if appropriate.

Of the 36,000 recalls the FDA oversaw in 2017, about a third of those were Class I, Stearn said.

Oversight is the extent of power the FDA has over recalls since the agency does not formally approve them, Stearn added, responding to a question by Representative Buddy Carter, a Georgia Republican.

Stearn also said that the FDA began revising its oversight of food recalls when it was given the preliminary results of the Health and Human Services audit in 2016.

Among the steps taken, Stearn said the agency established a monthly monitoring system, developed a system to address the timeliness of each step in the recall process, and clarified when the FDA can informally recommend that companies cease distribution or recall hazardous products.

Stearn said one of the most significant steps the FDA took was to establish a team to review complex and unusual food safety situations.

“The team meets at least weekly and makes recommendations about what actions to take and how to make sure they occur,” he said.

Seated from left at the witness table are Gloria Jarmon, the deputy inspector general for Audit Services at Health and Human Services, and Douglas Stearn, the acting deputy director for regulatory affairs at the Center for Food Safety and Applied Nutrition. The witnesses delivered testimony at a Jan. 19, 2017, hearing on Food and Drug Administration oversight of product recalls.

Stearn’s testimony came the day after the FDA announced that it would expedite public notification of product recalls, including of food products. Now, the agency says it will notify the public as soon as possible, rather than waiting for a formal investigation to conclude.

The audit found that the FDA failed nearly half the time to conduct health-hazard evaluations in a timely manner, taking an average of 47 working days to complete the evaluations.

The audit also found deficiencies in the FDA’s monitoring of recalls, and said the agency lacked internal timeframes to trigger recall requests.

Stearn testified Friday alongside Gloria Jarmon, the deputy inspector general for Audit Services at Health and Human Services.

“If FDA had established risk-based internal timeframes, it might have identified reluctant firms earlier in the food-recall process and taken appropriate action to protect public health,” Jarmon testified.

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