* Lawsuit claims U.S. agencies failed to issue timely
* FDA argues it cannot meet some deadlines because of
By Carey Gillam
Dec 3 Creating new rules for food safety is too
complex a task to be completed quickly and a lawsuit seeking to
compel government action should be dismissed, according to the
U.S. Food and Drug Administration.
The FDA said that though it was behind schedule in
modernizing food safety regulations as set out in a law signed
in January 2011, the agency's broad role in regulating a $450
billion domestic and imported food business requires additional
"The enormity and scope of the task given to FDA cannot be
overstated," the FDA said in a motion filed Friday 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 non-profit public interest advocacy groups.
The groups allege the FDA is failing to implement and
enforce the Food Safety Modernization Act, which is aimed at
preventing food-borne illnesses that cause thousands of deaths
The groups allege 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 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.
Last year's law was the first food safety overhaul in over
70 years for the United States. 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. They would also force food companies to
identify possible causes of contamination and specify actions to
According to the lawsuit, FDA has failed to meet hundreds of
deadlines established by the law, seven of which require
promulgation of major food safety regulations.
But in its motion to dismiss the lawsuit, the FDA said its
decisions regarding enforcement actions are not subject to
judicial review. It also said that it had not "unreasonably
delayed" promulgation of regulations.
"FDA has devoted enormous effort and resources to developing
the novel and complex regulations," the agency said.
"Although FDA has been unable to meet the aggressive
statutory timelines... there is no indication that Congress
believed that strict adherence to those timetables is more
important than careful consideration and development of these
complex regulations..." the agency said.
George Kimbrell, senior attorney for the Center for Food
Safety, said the FDA is breaking the law.
"They are not disputing that they missed the deadlines
Congress set. They are just arguing those deadlines essentially
don't matter," Kimbrell said.
(Reporting by Carey Gillam in Kansas City; Editing by Kenneth