Date: Jun 11, 2019
Category:

In October 2018, the Center for Food Safety and the Center for Environmental Health sued the U.S. Food and Drug Administration (FDA) for failing to meet statutory deadlines found in 2011’s Food Safety Modernization Act (FSMA) and the Administrative Procedures Act.

The Center for Food Safety and the Center for Environmental Health 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.

As of Monday, it was announced that the parties have settled the matter and will not 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).

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 was in 2012-14, and brought a newly imposed deadline for FDA’s adoption of its seven basic rules for FSMA.

WG Staff Contact

Hank Giclas
Sr. Vice President, Strategic Planning, Science & Technology
949-885-2205

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