Food Safety News is reporting this week that a pair of San Francisco Bay area activist organizations are continuing to “pressure FDA about keeping the Food Safety Modernization Act (FSMA) rulemaking on a schedule,” and 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.”While the two groups filed complaint against FDA last week in US District Court for Northern California, the named defendants, Secretary of Health and Human Services Alex Azar and FDA Commissioner Scott Gottlieb, have not been served and government attorneys have yet to be assigned to the case, FSN said.The pending litigation is similar to actions brought by the Center for Food Safety in 2012 after FDA 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, devastating 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 FSMA was signed into law in 2011 after it passed Congress in 2010. FSN notes that 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 claim the U.S. is experiencing a “continuing epidemic of foodborne illness” and documents outbreaks of incidents that have occurred under the FSMA. “At the time this complaint was written, there have already been nineteen multistate foodborne illness outbreaks just in 2018, the highest number of outbreaks since 2006,” it says.The plaintiffs also argue that “the continued foodborne illness epidemic in our country shows that 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,” said 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 foods 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 DC 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 will be.Food safety is always a highly visible priority for consumers, but the objectives of the FSMA are very expensive and difficult to achieve—and FDA has been quite timid in its implementation of the new law, skeptics charge. Certainly, attempts to designate “high risk” foods will be highly political and difficult — but also will be increasingly difficult to avoid. This is a high stakes challenge and should be watched closely by producers as it proceeds, Washington Inside believes.
Welcome
