By Dan Flynn

Two San Francisco Bay area activist organizations that previously pressured the FDA about keeping the Food Safety Modernization Act (FSMA) rulemaking on a schedule are again pushing for the agency to meet the Act’s mandates.

“FDA’s failure to implement FSMA’s critical food safety regulations by the statutory deadlines is an abdication of the agency’s fundamental responsibilities,” according to the civil complaint filed by The Center for Food Safety in San Francisco and the Center for Environmental Health in Oakland.

“Moreover, the agency’s unlawful withholding is putting millions of lives at continued risk from contracting foodborne illnesses, contrary to Congress’s commands. This lawsuit, therefore, seeks to require FDA to complete the high-risk food actions FSMA requires by Court-established deadlines.”

The two watchdog groups filed the complaint against the Food and Drug Administration on Oct. 15 in U.S. District Court for Northern California. The named defendants, Secretary of Health and Human Services Alex M. Azar and FDA Commissioner Scott Gottlieb, have not been served, and government attorneys have yet to be assigned to the case.

The pending litigation, however, is similar to actions brought by the Center for Food Safety in 2012 against FDA after the agency missed several congressionally mandated deadlines for implementing FSMA regulations. That lawsuit was settled by the group and the federal government agreeing to deadlines that were included in a consent decree.

This time, the plaintiffs say FDA has failed to meet deadlines for classifying and designating “high risk” foods and to create record-keeping requirements for facilities handling those foods.

“The overarching purpose of these FSMA ‘high risk’ food provisions is to improve FDA’s food-tracing capabilities and expedite the recall process during an outbreak,” according to the complaint.

“In the years that FDA has failed to complete these requirements, devasting foodborne illness outbreaks have unfortunately continued and spread across the country, killing hundreds and hospitalizing thousands of Americans; as Congress intended, these foodborne illness outbreaks may have been prevented or lessened if these FSMA measures were in place.

The civil action is being brought under the federal Administrative Procedures Act.

The FSMA was signed into law by President Barack Obama on Jan. 4, 2011, after being approved by Congress in late 2010. The FSMA’s purpose is to prevent foodborne illness outbreaks, not just react to them after they occur.

The federal Centers for Disease Control and Prevention estimates 47.8 million illnesses, 127,839 hospitalizations, and 3,037 deaths are experienced annually in the United States from foodborne diseases.

The plaintiffs also claim the U.S. is experiencing a “continuing epidemic of foodborne illness” by documenting outbreaks of foodborne illnesses that have occurred under the FSMA. “At the time this complaint was written, there have already been nineteen multistate foodborne illnesses outbreaks just in 2018, the highest number of outbreaks since 2006,” it says.

“As the continued foodborne illness epidemic in our country shows, there is an urgent need to designate high-risk foods and establish their reporting requirements so that our government can rapidly and effectively respond to outbreaks, says Ryan Talbott, Center for Food Safety staff attorney. “Congress required this to be done years ago, with good reason. As we have in the past, we will continue to hold FDA accountable to protect public health.”

Congress imposed a January 2012 deadline for FDA to designate high-risk food and January 2013 for record keeping requirement for those facilities. Since 2013, the complaint says outbreaks of foodborne illnesses have “reached all fifty states, Washington D.C. and Puerto Rico.”

When medical expenses and loss of productivity are taken into account, the plaintiffs say foodborne illnesses cost the economy over $93 billion annually.

FDA has not yet responded to the complaint.   It has both conducted a pilot program on high-risk foods, and it invited public comments on a draft approach for the review and evaluation of data to designate high-risk foods.  But FDA’s website is not clear on the current approach.