Tuesday, September 04, 2012 12:24 PM PT
FDA Shirked Its Duties on Food Safety, Groups Say

     (CN) - The Food and Drug Administration missed seven deadlines to implement key food safety regulations, putting millions at risk of getting sick from tainted food, two nonprofit public interest groups claim in federal court.
     The Center for Food Safety and the Center for Environmental Health sued the heads of the FDA and the Office of Management and Budget in federal court in San Francisco, claiming they failed to issue final regulations for the Food Safety and Modernization Act (FSMA).
     The act, signed into law by President Obama last January, sought to help prevent food contamination instead of merely containing outbreaks.
     The public interest groups say the FDA "has missed not one, not two, but seven critical deadlines, and counting, in failing to implement FSMA's major food safety regulations" (italics in original).
     The agency submitted several delayed regulations to the Office of Management and Budget, where they await approval.
     But the group's say the FDA can implement the regulations without the office's approval.
     "FDA's failure to implement FSMA's critical food safety regulations by their statutory deadlines is an abdication of the agency's fundamental responsibilities," the complaint states.
     "Moreover, the agency's unlawful delay is putting millions of lives at risk from contracting foodborne illnesses. This lawsuit seeks to require FDA to immediately promulgate the FSMA regulations required by law and enforce self-executing sections of FSMA even without finalized regulations."
     The Centers for Disease Control and Prevention estimate that each year 48 million people get sick, 128,000 are hospitalized and 3,000 die due to foodborne illnesses.
     When the FSMA was signed into law, Congress established deadlines to implement different tasks by certain dates.
     These deadlines include "the promulgation of regulations; completion of industry guidance documents and reports; enhanced tracking mechanisms for food products to help identify possible contamination incidents; and a consumer-friendly website for recall information and foodborne illness outbreaks," according to the lawsuit.
     "FDA has failed to meet hundreds of these deadlines, seven of which are the required promulgation of major food safety regulations," the centers claim.
     Among the missed deadlines, the FDA allegedly failed to publish a notice of proposed rulemaking establishing science-based minimum standards for safe production and harvesting of certain fruits and vegetables.
     "The numerous preventative measures contained in FSMA required to be carried out by FDA is critical, as they would dramatically reduce the number of illnesses caused by foodborne pathogens in the U.S., as well as reduce the economic healthcare burden of treating these problems," the complaint says.
     "In an era of seeking ways to lower healthcare costs, prevention of foodborne illness and outbreaks should be paramount."
     The groups note that there have been "devastating outbreaks" of food poisoning since Congress passed FSMA, including listeria in cantaloupes and apples, and salmonella in cilantro and tomatoes.
     The nonprofits seek a court order forcing the agency to adhere to the FSMA deadlines, and the Office of Management and Budget to approve the regulations.
     They are represented by Paige Tomaselli of the Center for Food Safety.
     Defendants are FDA Commissioner Margaret Hamburg and Jeffrey Zientz, acting director of the Office of Management and Budget.