Federal study criticizes FDA recall procedures - The Packer

Federal study criticizes FDA recall procedures

06/23/2011 06:40:00 AM
Chris Koger

Putting the U.S. food supply at risk, the Food and Drug Administration has generally failed to promptly initiate recalls, allowed some food companies to continue shipping despite failed inspections and often ignored its own procedures.

That’s the conclusion of the FDA’s Office of Inspector General in a new report, based on a year-long evaluation of study of 17 food recalls from 2007 to 2008. The study included a variety of food recalls, including those involving cheese, mussel meat, fish and four separate recalls of fresh cantaloupes from Honduras.

The inspector general’s office directed the FDA to review the report as it implements the Food Safety Modernization Act.

The FDA, the produce industry and other food companies need to improve recall practices, said Dave Gombas, senior vice president for food safety and technology at the Washington, D.C.-based United Fresh Produce Association.

“Because food recalls are such a rare event, most companies aren’t prepared to do an effective recall,” Gombas said. “It is a weakness for both FDA and food facilities.”

Amy Philpott, senior director with Watson Mulher LLC, Washington, D.C., said companies want to do the right thing.

“I’m not convinced it matters if (food recall guidance) is mandatory.”

Produce companies can face different expectations from regional FDA food recall coordinators depending on what part of the country they live, she said.

Gombas said he recently counted about 60 fresh produce recalls in 2010. He said every fresh produce marketer should take steps to be ready for a recall.

“It is the difference between a painful recall and a very painful recall,” Gombas said.

Joe Pollock, category manager for Wuhl Shafman Lieberman Corp., Newark, N.J., said the company has well-documented recall procedures. The company was one of four involved in the 2008 recalls of Honduran cantaloupes, along with Firebaugh, Calif.-based Legend Produce, Gonzales, Calif.-based Taylor Fresh and Jard Marketing Corp., Lawrence, Mass.

“It is pretty clear-cut,” Pollock said. “We know everything down to the pallet and the case.”

Pollock said timing is a key issue for FDA. As soon as it finds a problem with a particular lot, the agency must notify the supply chain immediately.

“Anything before (the product) gets out to the general public would be beneficial,” he said.

Philpott, who works with companies on recall procedures and policies, said she’s worked with companies that were informed of three-week-old FDA tests.

However, Philpott said she believes the study would find improvement if it looked at data from the past couple of years.

“If the same report were done for 2009, 2010 or this year, I think you would see big improvements,” she said. “I think we have seen drastic improvements in food companies’ abilities to respond quickly because they are preparing.”

Development and implementation of food recalls was not adequate to ensure the safety of the U.S. food supply, according to the report, and the FDA often didn’t follow its own procedures, according to the report.

Some firms did not promptly initiate recalls, according to the report, but Philpott said her experience has been that produce industry firms generally respond very quickly to a positive test for pathogens.

Other problems included weak and inaccurate recall communications from companies conducting recalls, as well as incomplete recall status reports that the firms are supposed to provide the FDA.

The FDA failed to conduct inspections or obtain complete information on the contaminated products in 14 out of 17 recalls, according to the report. The agency also didn’t conduct any audit checks of consignees in five of the 17 recalls and conducted untimely and incomplete audit checks in the other 12 recalls.

The agency also failed to review the recall strategy of firms and promptly issue notification letters to firms covering the review results, according to the report.

Finally, the FDA did not witness the disposal of the products or obtain the required documentation showing that the products were disposed of in 13 of 17 recalls.

The FDA responded, saying the food recall policy has been in place since 1978, and future proposals may include using third parties to conduct some aspects of recall audits and “bolstering” guidance.

The key part of preventing foodborne illness is done with research and best practices throughout the supply chain, Philpott said.



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goodvaguy    
usa  |  June, 26, 2011 at 07:14 AM

I wonder if the IG looked at what role Congress had in causing these problems? I doubt it, because Congress runs the IGs. The perception that the IGs are independent is only perception not truth.

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