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Obama Administration Sued for Delay of FSMA Implementation

FDA missed important deadlines, say food safety advocates

The U.S. Food and Drug Administration and the White House Office of Management and Budget were sued this week for the months-long delay in implementing the Food Safety Modernization Act.

President Obama signed FSMA into law in January 2011, but 4 of the most central regulations mandated by the law have been under review at OMB’s Office of Information and Regulatory Affairs for more than 8 months — an unusually long delay for measures backed by industry and consumer groups alike.

In all, FDA has now failed to promulgate 7 major food safety regulations, according to a complaint filed in federal court Thursday by the Center for Food Safety and the Center for Environmental Health.

The suit seeks a court order that would require FDA to enact FSMA regulations by a court-imposed deadline, which would prevent OMB from further delaying implementation with its lengthy review of the regulations.

The move comes just months before the presidential election, which some stakeholders speculate is a factor in holding back the rules, since they could be construed as job-killing regulations during a rocky economic recovery.

“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.”

The key rules under review — preventative controls for food facilities, preventive controls for animal feed facilities, the foreign supplier verification program and produce safety regulations — were supposed to be the key to shifting the U.S. food safety system from primarily reactive to prevention-focused. Each of these measures should have either been in the rulemaking process or have been implemented by now and, the complaint points out, there are at least 9 more FSMA deadlines coming up in early 2013.

Public health advocates point to the steady parade of large, multistate foodborne illness outbreaks as evidence the system needs an upgrade — and sooner rather than later. Just this week, the federal Centers for Disease Control and Prevention is investigating 2 large Salmonella outbreaks, one linked to imported mangoes, the other to cantaloupes grown in Indiana.

“This unreasonable and dangerous political foot-dragging on FSMA has to stop now,” said Charles Margulis, Food Program Director at Center for Environmental Health. “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.”

The complaint argues that FDA has the authority to promulgate the regulations without waiting for OMB’s approval. The fact that FDA has missed statutory deadlines is “an abdication of the agency’s fundamental responsibilities,” it says.

The suit names FDA Commissioner Margaret Hamburg and Acting Director of OMB Jeffrey Zients as defendants.

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