Posted August 19, 2013
According to a recent federal district court ruling issued by Judge Phyllis Hamilton of the U.S. District Court of Northern California, the Food and Drug Administration (FDA) may not extend deadlines to publish final rules in implementing the Food Safety Modernization Act (FSMA), signed into law in 2011.  The order is available here.

The FSMA was passed by the 111th Congress in December of 2010 in response to several multistate foodborne illness outbreaks related to FDA-regulated foods including: bagged fresh spinach contaminated with E.coli 0157:H7, Salmonella in Serrano peppers, melamine in pet food, peanut butter and other peanut products contaminated with Salmonella Typhimurium, and a nationwide recall of more than 500 million eggs due to contamination from Salmonella Enteritidis.  This comprehensive food safety legislation focuses on foods regulated by the FDA and amends FDA existing structure and authorities, via the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.) and is the largest expansion in food safety since the 1930s.  The FSMA is designed to increase the frequency of inspections at food facilities, enhance record-keeping requirements, mandate product recalls if a firm fails to voluntarily recall an item, require comprehensive prevention-based controls throughout the food supply, improve foodborne illness tracking systems, and increase scrutiny of food imports. 

For detailed information on the FSMA, please visit the National Agricultural Law Center website hereand here.

In August of 2012, the Center for Food Safety(CFS) filed a lawsuit against FDA over FSMA deadlines originally ordered by Congress to be completed by July 2012, according to a Food Safety News article and the CFS press release.  On April 22, 2013, the court ruled that FDA violated the FSMA and the Administrative Procedures Act when it failed to issue FSMA regulations by the FSMA-established deadlines.  The April 2013 order granting CFS’s motion for summary judgment is available here.  

On June 21, the court issued an order for injunctive relief which set deadlines for FDA to publish proposed regulations by November 30, 2013, close the comment periods by March 31, 2014, and publish the final regulations in the Federal Register by June 30, 2015.  The June order is available here. 

FDA moved to amend the June order, which the court granted in part and denied in part in its latest order on August 13, available here.  In this ruling, the court extended the deadline for the “proposed sanitary transport rule 60 days to January 31, 2014” and extended the comment period for this rule 60 days to May 31, 2014.  The court, however, did not extend the final rule deadline and denied the extension requested by FDA for promulgation of the intentional adulteration rule, stating that the “court understands the FDA’s position, and is in sympathy with it, but remains of the opinion that the dispute here is between the FDA and Congress.”