Thursday, September 6, 2012

Lawsuit Targets FDA, OMB on Stalled Food Safety Act; Food Safety and Modernization Act rules unlawfully delayed as risks increase, public health threatened

Food Safety and Modernization Act rules unlawfully delayed as risks increase, public health threatened (August 30, 2012 CFS News Release)

The Center for Food Safety (“The Center”) today filed suit in federal court against the U.S. Food and Drug Administration (FDA) and Office of Management and Budget (OMB) for their failure to implement several critical food safety regulations, as required by the Food Safety and Modernization Act (FSMA). Signed into law by President Obama on January 4, 2011, the Act has been unlawfully delayed for more than a year and a half, leaving vital prevention remedies to substandard U.S. food safety rules unenforceable, and the nation’s public health in jeopardy.

According to the Centers for Disease Control and Prevention (CDC), an estimated one in six Americans (48 million people) becomes ill from foodborne diseases each year. Approximately 128,000 are hospitalized and 3,000 die based on exposure to pathogens present in the food supply. FSMA targets a range of necessary preventive measures that would immediately and aggressively work to reduce the impact of many illnesses caused by U.S. foodborne hazards.

“If the Obama Administration has lost the political will to make FSMA a reality, we’re here to help them find it,” said Andrew Kimbrell, executive director of Center for Food Safety. “It’s a disgrace that a crucial, lifesaving law sits idle while the bureaucracies of FDA and OMB grind along without a hint of results. The American people shouldn’t have to wait another second for safer food policies that are already law.”

FSMA was established to upgrade U.S. food safety laws, mandating FDA to require preventive controls across the food supply, inspect food producers as an industry accountability measure and ensure imported foods meet U.S. consumer safety standards. Congress ordered specific implementation deadlines within the FSMA legislation that require FDA to complete various tasks by a certain date, including the release of regulations, completion of industry guidance documents and reports, implementation of enhanced food product tracking mechanisms and creation of a consumer website for recall information and foodborne illness outbreaks.

More than eighteen months after the law’s passage, and untold numbers of food safety illness episodes later – including last week’s salmonella outbreak from Indiana-based cantaloupe farms resulting in two deaths and 178 sickened people in 21 states – FDA has yet to enact any implementing of FSMA’s food safety regulations.

“Parents having to worry if feeding melon to their child will lead to hospitalization or even death is unconscionable,” said Michele Simon, policy consultant for the Center. “Congress and the President hammered out this law with the clear intent of protecting the nation’s food supply and preventing more outbreaks. Every day the Administration delays mean another day Americans are at risk.”
The lawsuit seeks a court order that requires FDA to enact the FSMA regulations by a court-imposed deadline and prevents OMB from delaying FDA’s compliance with that deadline.

“This unreasonable and dangerous political foot-dragging on FSMA has to stop now,” said Charles Margulis, Food Program Director at Center for Environmental Health, co-plaintiff in the lawsuit. “While illness outbreaks continue and Americans question the health and safety of their food supply, FDA issues excuses instead of new regulations. The time is now for modernizing our federal food safety laws.”

A copy of the joint filing by the Center and CEH can be found here

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