Delays in writing rules to carry out the Food Safety Modernization Act (FSMA) landed the Food and Drug Administration (FDA) in court. On June 21, US District Judge Phyllis Hamilton of the Northern District of California ordered the agency to release all proposed FSMA regulations by Nov. 30, 2013, with comments to close no later than March 31, 2014. Final regulations must be published in the Federal Register out by June 30, 2015.
Congress wrote a July 2012 deadline into the law to compel FDA to complete rulemaking promptly. That date came and went without results. In August 2012, the Center for Food Safety (CFS), a Washington, DC-based advocacy group, sued FDA over that failure.
New federal regulations are routinely reviewed by the Office of Management and Budget (OMB). CFS asked that step be omitted for FSMA rules, but the court disagreed. It also declined to require the quarterly progress reports CFS asked FDA to supply.