FSMA Rule Promulgation Marches On, But Final Deadlines Remain Uncertain
The final schedule for promulgation of Food Safety Modernization Act (FSMA) required-regulations remains in flux. Last month, we reported that the U.S. District Court for the Northern District of California recently ruled in favor of two public interest organizations that challenged through litigation the U.S. Food and Drug Administration’s (FDA) delay in issuing FSMA regulations. Balancing the organizations’ implore that the Court advance consumer interest in a safe food supply by requiring the FDA to issue the remaining rules without further delay against FDA’s request for the time it believes is needed to adequately address the complexities that underlie the regulations, on June 21, 2013, the Court set the following deadlines for FDA action:
• November 30, 2013, by which remaining proposed FSMA regulations must publish for comment;
• March 31, 2014, by which public comments must be submitted; and