Jay Sjerven

The Food and Drug Administration’s food recall process sometimes falls short of ensuring the safety of the nation’s food supply, according to a review published by the Office of the Inspector General of the Department of Health and Human Services in late December. The conclusion reflected findings of a review of documentation related to 30 voluntary food recalls “judgmentally selected” from the 1,557 food recalls reported to the F.D.A. between Oct. 1, 2012, and May 4, 2015.

The O.I.G. said prior reviews of the F.D.A. food recall process were conducted before the passage of the F.D.A. Food Safety Modernization Act, which, among other things, granted the F.D.A. authority to order mandatory recalls and require companies to recall certain harmful foods. The O.I.G. also noted it had issued an early alert memorandum to the F.D.A. in June 2016 raising concerns that the F.D.A. did not have adequate policies and procedures to ensure that companies take prompt and effective action in initiating recalls. The memorandum and the review that culminated in the December report encouraged the F.D.A. to make major changes in its oversight of the recall process.

The O.I.G. review identified deficiencies in F.D.A.’s oversight of recall initiation and monitoring and in recall information captured and maintained in the recall enterprise system (R.E.S.). Specifically, the O.I.G. found that the F.D.A. could not always ensure that companies initiated recalls promptly.

F.D.A. food safety
The F.D.A. does not have adequate procedures to ensure that companies take prompt action in initiating voluntary food recalls.

The O.I.G. also found that the F.D.A. did not always evaluate health hazards in a timely manner, issue audit checks at the appropriate level, complete audit checks in accordance with its procedures, collect timely and complete status reports from recalling companies, track key recall data in the R.E.S., and maintain accurate recall data in the R.E.S.

Recalls were not always initiated promptly because the F.D.A. did not have adequate procedures to ensure that companies take prompt action in initiating voluntary food recalls, the O.I.G. said. In addition, the F.D.A. had not established risk-based internal timeframes for reaching certain milestones, such as when to instruct recall staff to request that companies voluntarily recall their products, which delayed the F.D.A. from taking further actions in some recalls.

The F.D.A.’s monitoring of recalls was not always effective because F.D.A. staff did not always follow procedures, or those procedures were inadequate, the O.I.G. said. As a result, the F.D.A. could not consistently ensure that the recalling companies’ consignees appropriately removed harmful products from retail stores and other points in the distribution chain.

The O.I.G. review provided several recommendations, including establishing set timeframes for the F.D.A. to discuss the possibility of a voluntary recall with a company and initiating the use of its mandatory recall authority after it has determined that the legal standard for use of that authority has been met and a company is not willing to voluntarily conduct a recall. Another recommendation called for the F.D.A. to establish performance measures for the amount of time between the date the F.D.A. learns of a potentially hazardous product and the date a company initiates a voluntary recall, for monitoring performance and for refining operating procedures as needed.

“A lot has changed since that timeframe when it comes to our food safety practices ,” said Scott Gottlieb, Ph.D., F.D.A. administrator. “But I know that much work remains to be done if we’re going to provide the highest assurance of safety. We’ve taken the O.I.G. recommendations to heart and worked quickly to put in place measures to address the proposals that the O.I.G. outlined.”

Dr. Gottlieb said one of the most significant steps the F.D.A. took to improve recall procedure was the establishment of a team of senior leaders charged with reviewing complex or unusual food safety situations and determining the proper action to address the problem if it isn’t clear. The team meets at least weekly and makes recommendations about what actions to take and how to make sure they occur.

“Over the past year, this team of senior leaders, called the SCORE team (Strategic Coordinated Oversight of Recall Execution), has made a big difference in these situations,” Dr. Gottlieb said. “In addition to facilitating recalls and import alerts for the detention of products entering the United States, SCORE initiated or helped to expedite the process for suspending the registration of two food facilities, actions that block the facilities’ ability to distribute food to the marketplace.

“Building on these early efforts, we intend to say more in early 2018 on additional policy steps we’ll take as part of a broader action plan to improve our oversight of food safety and how we implement the recall process.”