Audit criticizes industry, FDA handling of food-import recalls

Jun 22, 2011 (CIDRAP News) – Food companies have often ignored federal guidelines for conducting recalls of potentially harmful imported foods, and the Food and Drug Administration (FDA) has been lax in following its own procedures for overseeing recalls, according to a government audit.

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) based those findings on a review of the FDA's monitoring of 17 recalls of food imports that occurred from July 2007 through June 2008.

"FDA's guidance for developing and implementing food recalls was not adequate to ensure the safety of the nation's food supply because it was not enforceable," the OIG report says. "In addition, FDA did not always follow its own procedures for ensuring that the recall process operated efficiently and effectively."

In a statement included in the report, the FDA said recalls have been generally successful in taking products off the market. But the agency agreed with the OIG's recommendations, and it said the new food safety law and other steps under consideration will improve the FDA's ability to ensure that recalls are carried out properly.

The FDA provides voluntary guidance for the food industry on recalls, covering initiation, strategy, communications, status reports, and product disposal, according to the report.

The FDA oversaw 40 "Class I" (highest health hazard) imported-food recalls in the year covered by the study, the report says. The 17 recalls reviewed by the OIG included 7 for Salmonella, 5 for Listeria monocytogenes, 4 for Clostridium botulinum, and 1 for high lead levels in beverage pitchers.

The OIG's major findings on food importers' handling of recalls included:

  • Firms did not initiate recalls promptly. Two of the 17 recalls were not launched until 28 and 102 days after the FDA became aware of the contamination.
  • Firms fell short in reporting their recall strategies. In 3 of the 17 recalls, firms did not submit recall strategies. In the other 14 recalls, the strategies submitted did not contain complete information.
  • In 13 of the 17 recalls, firms did not issue accurate and complete recall communications to their consignees.
  • Status reporting to the FDA was inadequate. Of the 17 recalling firms, 5 did not submit any status reports, 10 submitted untimely and incomplete reports, and 2 submitted timely but incomplete reports.

Because the FDA's food recall guidance is strictly voluntary, the agency can't compel firms to follow it, the report notes.

The report also cites four types of lapses in the FDA's compliance with its own stated procedures for overseeing recalls. It says the agency:

  • Did not inspect facilities or obtain complete information on the contaminated products in 14 of the 17 recalls
  • Did not conduct audit checks of consignees in 5 of the 17 recalls and conducted untimely and incomplete audit checks in the remaining 12 recalls
  • Did not review recall strategies and promptly provide firms with the results and essential instructions in all 17 recalls
  • Did not witness the disposal of the products or obtain the required documentation that the products had been properly disposed of in 13 of the 17 recalls

The OIG said the FDA should follow its own procedures in monitoring recalls and should consider the OIG findings in implementing the FDA Food Safety Modernization Act (FSMA), signed in January. The new law increases the FDA's authority and responsibility to prevent food contamination.

In its statement in the report, the FDA agrees with those recommendations. At the same time, it says that though the recall guidance is nonbinding, "recalls of violative products have been, on the whole, successful in removing these products from use and preventing harm to the public."

In the face of increases in the number of recalls, the FDA is currently studying how to make its recall oversight process as fast and efficient as possible, the agency said. That study has produced several proposals, which are now being evaluated.

The proposals include "exploring the use of third parties to conduct some aspects of recall audit checks; triaging incoming recalls based on risk profiles in an effort to streamline the recall process; bolstering guidance to industry and enhancing opportunities to share best practices; improving consumer communications; and strengthening the management of the overall recall process."

See also:

HHS OIG report

FDA FSMA information page

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