Northern District of California federal judge Phyllis Hamilton sided with the Center for Food Safety and Center for Environmental Health in a lawsuit filed over Food Safety Modernization Act deadlines, which have been delayed by the FDA. The agency was ordered in 2011 by Congress to complete implementation of the FSMA by July 2012, but the final regulations are not expected until June 2015. On August 13, the court granted a sixty-day extension for one proposed rule, denied an extension for another, and reiterated the requirement for the final regulations to be published in the Federal Register by June 2015.
The Food Safety Modernization Act (FSMA) aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contaminations after they happen, to preventing them from occurring in the first place. Annually, about 48 million people—one out of six Americans—suffer from foodborne illnesses. More than a hundred thousand are hospitalized, and thousands die each year. The plaintiffs claim that the FDA could be preventing food poisoning deaths with enforcement of the FSMA rules, once fully implemented. The FDA could prevent contamination by holding food producers accountable, inspecting and potentially refusing to import contaminated foods, and for the first time, be able to enforce mandatory recalls of food rather than relying on voluntary recalls by food producers.
Judge Hamilton denied the FDA’s request for nonspecific extension of the final rule deadline to some time in the second half of 2017. The deadline date for all seven FSMA final rules will remain June 30, 2015. At that time, all final rules should be published in the Federal Register. Also denied was the FDA’s request for a stay of injunction until the Solicitor General could review the case.
History of the Lawsuit
Delays at the Office of Management and Budget, as well as extension of comment periods by the FDA have stalled the act. The suit was originally filed by the CFS in August 2012. Judge Hamilton set an injunction remedy against the FDA this June that set a new schedule of deadlines. At that time, the court ordered the FDA to publish all proposed regulations by November 30, close the comment period on FSMA sixty days later, and publish all final regulations in the Federal Register no later than June 30, 2015.
“The court ruled that FDA violated the law in April 2013, and set an injunction remedy in place in June, with new deadlines for draft and final rules,” the CFS wrote in a press release. “FDA moved for reconsideration or a stay of the injunction with regard to the deadlines for two of those rules, food transport safety and intentional adulteration. Judge Hamilton denied FDA’s motion and kept firm the dates for completion of all the rules.”
When Congress enacted the FSMA, it included as part of the statute deadlines to set regulations in seven specific areas. The
FDA missed all the deadlines. To date, the FDA has published proposed rules in only four of the seven areas, and anticipates publishing a proposed rule in a fifth area in November 2013.
Why Can’t the FDA Meet the Deadlines?
The FDA asked for regulations in two areas to be extended because of the complexity of the issues, the amount of work required and because the FDA was “never given the opportunity before the court issued the injunction to respond to the schedule” set by the court.
In a declaration to the court, FDA Deputy Commissioner for Foods and Veterinary Medicine, Michael R. Taylor, detailed the reasons the FDA can’t comply with the court’s schedule. The FDA anticipates publishing the sanitary transport proposed rule by January 31, 2014, sixty days after the court’s deadline. Taylor adds that the FDA can’t publish the intentional adulteration proposed rule until the second half of 2015, and that it projected releasing the final rule during the second half of 2017.
Existing intentional contamination controls are currently voluntary, so the FDA hasn’t yet regulated them, Taylor says. The FDA needs to develop criteria where preventive controls are appropriate. The plaintiffs called the attempt to stall with an Advanced Notice of Proposed Rulemaking process instead of publishing the rule “the least responsive course short of inaction, and an agency should not be permitted to slow down the rulemaking process by adding an unnecessary step.”
The FDA already has established food safety vulnerability procedures that can be used as a basis for the contamination prevention rule. In its 2007 Food Protection Plan, the FDA said it had devoted “significant resources” over the previous six years to address what it called “food defense – defending the food supply against deliberate attack.” The FDA also maintains a website detailing tools and educational materials regarding intentional contamination, and regularly holds workshops on food security awareness and defense.