Court Orders FDA, Center for Food Safety to Propose FSMA Deadlines

By Josh Long Comments
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WASHINGTON—A federal judge on Monday ruled the U.S. Food and Drug Administration (FDA) violated the law by failing to issue food-safety regulations under statutory deadlines.

The FDA was ordered to confer with the plaintiffs, the Center for Food Safety and Center for Environmental Health, and prepare a joint statement by May 20 specifying proposed deadlines for finalizing the regulations under the Food Safety Modernization Act (FSMA).

By missing deadlines imposed by Congress, the agency failed to act under the Administrative Procedure Act, Phyllis Hamilton, a U.S. District Judge in the Northern District of California, ruled.

George Kimbrell, a senior attorney with the Center for Food Safety, hailed the decision as a victory for consumers.

"Every day without the FSMA regulations is another day where consumers are at unnecessary risk. Because of this decision our food will soon be safer from e coli and other threats," he said in a statement.

In the complaint filed last year, plaintiffs alleged FDA missed hundreds of deadlines, including the making of seven major food-safety regulations, putting consumers at risk of contracting foodborne illness.

Lawyers for the government have cited the challenges of meeting the deadlines and pointed out that FDA has made substantial progress implementing FSMA. Earlier this year, FDA published two proposed rules that establish preventative controls in human food facilities and science-based minimum standards for the safe production and harvesting of certain fruits and vegetables.

Shelly Burgess, a spokeswoman for FDA, said Tuesday the agency does not comment on pending litigation.

The 2-year-old FSMA was enacted into law in response to a number of high-profile foodborne illnesses.

The Centers for Disease Control and Prevention (CDC) estimates that each year foodborne illness kills 3,000 Americans and sends 128,000 people to the hospital.

The Foodborne Diseases Active Surveillance Network (FoodNet), which conducts surveillance in 10 areas of the country for laboratory-confirmed cases of infection caused by Listeria, Salmonella and other bacteria, published 2012 data that "showed a lack of recent progress in reducing foodborne infections and highlight the need for improved prevention," according to the CDC.

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