A consent decree that requires FDA to designate “high risk” foods by September 2020 and publish the record keeping requirements by November 2022 will set into motion new traceability demands under the Food Safety Modernization Act (FSMA).
Back in 2018, the Center for Food Safety (CFS) and the Center for Environmental Health sued FDA alleging that the Agency violated the FSMA and the Administrative Procedure Act by failing to meet the statutory deadlines and to publish the list of foods designated as high-risk on FDA’s website. The complaint sought a judgement requiring FDA to take actions described in the statute pursuant to a court-ordered timeline.
In the consent decree FDA agreed to a schedule for FDA action, 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).
Read more here.
