While the U.S. Food and Drug Administration (“FDA”) proposed two new food safety regulations in January 2013 in an effort to combat the steady rise of foodborne illnesses, the agency is still under fire for its alleged failure to adhere to statutory deadlines imposed by Congress in implementing major provisions of the 2011 Food Safety Modernization Act (“FSMA”). In a suit filed in August 2012, the Center for Food Safety and the Center for Environmental Health alleged that the FDA has missed several critical deadlines for implementing the FSMA, a law that completely changed the face of food safety regulations. Seeking “the timely implementation of FSMA and its urgently-needed improvements to food safety,” the Center for Food Safety argues that “without its implementing regulations, the [FSMA] is an empty vessel.”

Highlighting the FDA’s failure to comply with seven statutorily-imposed deadlines, the Center for Food Safety urged a California federal judge to impose an injunction and establish new deadlines by which the FDA must promulgate and finalize the mandated FSMA food safety regulations. The deadlines pertained to regulations addressing the following: (1) preventive controls for human food; (2) produce safety standards; (3) foreign supplier verification for importers; (4) preventive controls for animal food; (5) protection against intentional adulteration of food; (6) sanitary food transportation practices; and (7) third-party auditor accreditation. Acknowledging its failure to meet the specific implementation deadlines set forth by Congress within the FSMA legislation, the FDA maintains in its summary judgment motion that there has been no “inordinate” or “egregious” delay and that the agency has been “working diligently to develop the required regulations.” The parties argued their respective positions during a summary judgment hearing before a California federal judge on Wednesday, March 27, 2013.

Please see the related blog post, FDA Proposes Highly Anticipated Food Safety Regulations (January 11, 2013), for information pertaining to FDA’s Proposed Rules for Preventive Controls for Human Food and Produce Safety Standards. We will continue to monitor and provide updates regarding the FDA’s promulgation and implementation of the various FSMA food safety regulations.