FDA Enters Consent Decree on FSMA Rulemaking Timeline
The U.S. Food and Drug Administration (FDA) has entered a consent decree with the Center for Food Safety, which sued the agency over its alleged failure to comply with implementation rulemaking deadlines in the Food Safety Modernization Act (FSMA). Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., decree filed February 20, 2014). Under the agreement, FDA will withdraw its Ninth Circuit appeal and will comply with the following timeline for the adoption of final rules: (i) Preventive Controls for Human Food and Preventive Controls for Animal Food—August 30, 2015; (ii) Foreign Supplier Verification Program, Produce Safety Standards, and Accreditation of Third Party Auditors—October 31, 2015; (iii) Sanitary Transport of Food and Feed—March 31, 2016; and (iv) Intentional Contamination— May 31, 2016.
The deadlines may be extended by written agreement of the parties and court approval if “FDA believes good cause exists to seek an extension.” If agreement is impossible, the consent decree sets forth a procedure for FDA to seek modification. The court will retain jurisdiction to oversee compliance with the decree. Center for Food Safety senior attorney George Kimbrell said of the agreement, “This is a major victory for the health and safety of the American people. The first major update to our food safety laws since 1938 must now be implemented in a close-ended, timely fashion. That means safer food for American families.”
Meanwhile, the center has filed a new lawsuit against the Department of Health and Human Services and FDA, seeking a declaration that FDA has failed to follow legal rulemaking requirements as to food additives. Ctr. for Food Safety v. Sebelius, No. 14-0267 (U.S. Dist. Ct., D.D.C., filed February 20, 2014). Filed under the Administrative Procedure Act (APA), the complaint alleges that FDA has, for 15 years, relied on a proposed rule to exempt substances that are generally recognized as safe (GRAS) from regulation as food additives. “FDA’s implementation of the proposed rule without considering and responding to public comments, and its failure to promulgate a final GRAS rule, violates the rulemaking requirements of the APA,” the center claims. The proposed rule purportedly eliminated a petition process, established in the 1970s, which required proof that a substance was GRAS, involved FDA analysis of the data and allowed public comment.
According to the Center for Food Safety, FDA now allows “food manufacturers to decide whether a food additive requires FDA review. Under the proposed rule, which has never been finalized, FDA created a fast-track for manufacturers who believe a substance should be ‘generally recognized as safe’ (GRAS). In its lawsuit, [the center] identifies several substances allowed under the fast-track process that may pose health risks and asks the court to order FDA to fulfill its responsibility to protect public health.” The substances identified are volatile oil of mustard, olestra and mycoprotein (or Quorn). See Center for Food Safety News Releases, February 20, 2014.
Issue 514
