It was three years ago that the Office of Inspector General for the U.S. Department of Health and Human Services said the FDA did not have an efficient and effective procedure for food recalls.

It was among the first criticisms lodged against Food and Drug Administration over its own duties under the Food Safety Modernization Act, but it was not the last.

The Inspector General (IG) said the FDA needed to updat its policies and procedures for its recall staff to set fixed timelines for the agency to call for recalls and for food companies to initiate recalls as voluntary actions.

In late 2017, FDA’s commissioner at the time, Scott Gottlieb, admitted the recall process left something to be desired. “Sometimes the recall process does not work as well as we’d like,” he said.

“As part of the OIG report, last year (2016), the OIG reviewed a selecive sample of 30 food recalls initiated from 2012 to 2015, including some very challenging ones, which occurred over this three-year period,” Gottlieb continued. The OIG made a series of recommendations on how the agency might improve its management of recalls. A lot has changed since that timeframe when it comes to our food safety practices.”

But the FDA did not change fast enough as far as the Center for Food Safety and the Center for Environmental Health are concerned. The pair of non-governmental organizations (NGOs) sued FDA Oct. 15, 2018, for failing to meet statutory deadlines found in 2011’s Food Safety Modernization Act (FSMA) and the Administrative Procedures Act.

The NGOs said that under FSMA, the FDA must designate “high risk” food that requires additional record-keeping to protect public health. The original FSMA deadline for FDA to designate the “high risk” foods was 2012.

Gottlieb was initially named as the defendant in the lawsuit, but when he left government that honor was turned over to acting FDA Commissioner Norman E. Sharpless.

Monday it was announced that without admitting or denying the allegations made in the complaint, the parties have settled the matter and won’t require any further litigation.

In a Consent Degree that goes beyond recalls, the settlement between the Center for Food Safety and the FDA is built around a series of deadlines, including:

Sept. 8, 2020 – Deadline for FDA to designate the list of “high risk” foods as required by the FSMA Section 204(d)(2)(A).

Sept. 8, 2020 – Deadline for FDA to publish a proposed rule, including record-keeping requirements for high-risk foods, also as required by FSMA Section 204(d)(2)(A).

Nov.7, 2022 – Deadline for FDA to issue a final rule, including record-keeping requirements for high-risk foods, also as required by FSMA Section 204(d)(2)(A).

With the publication of the final rule, FDA agrees to publish the list of high-risk foods on its website as required by FSMA Section 204(d)(2)(A).

“This is a major victory for public health,” said Ryan Talbott, staff attorney for the Center for Food Safety. “FDA has sat on its hands for years, neglecting to make these high-risk designations, while outbreaks caused by Salmonella, E. coli, and other pathogens have sicked and killed people. This settlement ensures FDA will finally take these much-needed actions to reduce the threat of foodborne illness.”

Jaydee Hanson, policy director at the Center for Food Safety, said the settlement means FDA delays should be over.

“FDA needs to designate what these high-risk foods are and how they should be reported to that we can build a safer food system that prevents as many of these foodborne outbreaks as possible,” Hanson said.

This is the second time that the Center for Food Safety has sued to put FDA back on track on FSMA deadlines. The first action, in 2012-14, brought a newly imposed deadline for FDA’s adoption of its seven basic rules for FSMA.

The original FSMA deadline for FDA designating “high risk” foods was 2012.

By Dan Flynn