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Though it’s behind schedule, the U.S. Food and Drug Administration (FDA), Washington, D.C., says that creating new rules for food safety is too complex a task to be completed quickly and says a lawsuit seeking to compel government action should be dismissed.
The agency says the Food Safety Modernization Act (FSMA), which was signed into law in January 2011 to regulate the $450-billion domestic and imported food business, requires additional time.
“The enormity and scope of the task given to FDA cannot be overstated," stated the FDA in a motion filed late in November in U.S. District Court for the Northern District of California. The motion comes in response to a lawsuit filed in August by the Center for Food Safety and the Center for Environmental Health, both nonprofit, public-interest advocacy groups.
The groups maintain that the FDA is failing to implement and enforce the act, which aims to prevent food-borne illnesses that cause thousands of deaths each year. They contend that government officials have repeatedly missed mandatory deadlines for issuing final regulations required by the law and asked the court to order officials at both the FDA and the Office of Management and Budget (OMB) to start enforcing the law.
About 3,000 deaths are caused by food-borne illnesses and about 48 million people, or one in six Americans, get sick from food contamination every year, according to the Centers for Disease Control and Prevention (CDC).
FSMA was the first food safety overhaul in more than 70 years for the U.S. The rules would establish standards for possible sources of contamination of fresh fruits and vegetables and make importers responsible for the safety of food they import. Additionally, the updated regulations would force food companies to identify possible causes of contamination and specify actions to prevent them.
The FDA argues that the deadlines Congress set are irrelevant, though the lawsuit states that the FDA has failed to meet hundreds of deadlines established by the law, seven of which require promulgation of major food safety regulations.