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FDA Sued for Failure to Implement “High-Risk” FSMA Provisions by the Statutory Deadlines

The Center for Food Safety (CFS) and the Center for Environmental Health (CEH) filed suit against the FDA on October 15 for failure to implement provisions of the Food Safety Modernization Act (FSMA).  CFS and CEH assert FDA has failed to meet several important FSMA action deadlines related to FDA’s mandate to classify and designate certain foods as “high-risk” for foodborne illness purposes, and to create additional recordkeeping requirements for facilities handling such foods. These requirements are codified at 21 U.S.C. §§ 2223(d)(1)-(2), which states that such designations should be made no later than 1 year after January 4, 2011.

As background, the overarching purpose of FSMA is to “rapidly and effectively” identify recipients of a food to prevent or mitigate a foodborne illness outbreak. Thus, under Section 204 of FSMA, Congress included numerous provisions that focused specifically on the goal of “rapidly and effectively” preventing or mitigating foodborne illness. CFS and CEH allege that FDA failed to complete the following Section 204 mandated actions:

(1) In order to enhance the tracking and tracing of food, Congress required FDA to conduct pilot projects on potential food-tracing systems and report their findings. The findings were to be reported by October 1, 2011.

(2) FDA was to designate a classification of “high-risk” foods, meaning foods that were at the highest risk of being carriers of foodborne illness. FDA was to base a “high-risk” classification on a set of criterion, including known safety risks of the food, the history and severity of foodborne illness, outbreaks attributed to such foods, and the steps taken during the manufacturing process to reduce possible contamination. The “high-risk” classification was to be designated by January 4, 2012.

(3) Congress required FDA to promulgate a proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack or hold foods that are designated high-risk. The proposed rulemaking was to be promulgated no later than January 4, 2013.

(4) Congress required that FDA publish the list of designated “high-risk” foods on its website at the same time the agency promulgated the final rule food additional recordkeeping requirements.

According to CFS and CEH, FDA failed to meet the above-listed deadlines, and in some instances, did not adhere to Congressionally-required actions. While CFS and CEH acknowledge FDA belatedly conducted the pilot program and submitted its report to Congress in November 2016, they note that FDA has still not designated a “high-risk” foods classification, nearly five years after the Congressionally-mandated deadline. CFS and CEH state that FDA’s failure to implement these regulations by their statutory deadlines is “an abdication of the agency’s fundamental responsibilities.” And therefore, the organizations brought the lawsuit to require FDA to complete implementation of these actions by Court-established deadlines.

This pending litigation is, in essence, phase II of an action brought by CFS in 2012 against FDA after the agency missed seven statutory Congressional deadlines for promulgating FSMA’s food safety regulations. See Str. For Food Safety v. Hamburg, 954 F.Supp.2d 965 (N.D. Cal. 2013), referred to in the current complaint as FSMA I. The 2012 Court held that “FDA’s failure to promulgate the mandated regulations by their statutory deadlines constituted a failure to act under the Administrative Procedure Act (APA) and unlawful withholding of the regulations in violation of FSMA and the APA.” The Court granted injunctive relief and established a timeline for FDA to promulgate the final regulations. FDA met each Court-established deadline for FSMA I and promulgated the required rules. However, the “high-risk” classification was outside the scope of FSMA I, and hence is at the center of the current lawsuit.

FDA has yet to respond to the CFS and CEH complaint. Keller and Heckman will continue to monitor the developments of this case.

© 2019 Keller and Heckman LLP


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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...