Federal suit seeks court order requiring FDA to enact regulations by a court-imposed deadline & prevents OMB from delaying FDA compliance...
After decades of foodborne disease outbreaks, it seemed to be a heady day for America's worried eaters when President Obama, with no fanfare, signed the FDA Food Safety Modernization Act (FSMA) into law on January 4, 2011. Hailed by lawmakers, food safety advocates, and President Obama as a "historic" piece of science-based legislation that would provide sweeping changes to modernize the nation's food safety system, the $1.4 billion law has since languished, due to the Obama Administration's inexplicable dawdling on fully implementing crucial regulatory parts of the measure.
Since late 2011, the Food and Drug Administration's proposed new rules required by the law have been at the Office of Management and Budget, with four of the most central regulations sitting for more than eight months awaiting approval. On Thursday, the non-profit Center for Food Safety and Center for Environmental Health filed suit against FDA and OMB in a federal court in the Northern District of California for "their failure to implement several critical food safety regulations."
"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," noted the filing. It charges that FDA has failed to promulgate seven of the major food safety regulations in the Act. FDA Commissioner Margaret Hamburg and Acting Director of OMB Jeffrey Zients are named as defendants.
The suit seeks a court order requiring FDA to enact the FSMA regulations by a court-imposed deadline, and prevents the OMB from delaying FDA’s compliance with that deadline.
The Obama Administration's failure to move forward and implement the food safety regulations afforded by the Act has been the subject of news stories and editorials. The President has been accused by some critics of food-dragging on the measure due to being engaged in a tight re-election battle.
“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, in a statement about the suit.
Since President Obama signed the Act, there have been repeated national foodborne disease outbreaks that have included fatalities. The most recent outbreak is still going on: A Salmonella outbreak from cantaloupe raised on Indiana-based farms has resulted in two deaths and sickened at least 178 people in 21 states. A different foodborne disease outbreak with a total of 103 persons infected with Salmonella Braenderup from tainted mangoes has just been reported in 16 US states, according to the Centers for Disease Control and Prevention, with the majority of ill persons from California.
Cantaloupe is perhaps America's deadliest fruit: Last year, a different outbreak, this time of Listeria, killed 33 people and sent at least 143 citizens to the hospital. According to CDC, annually about 3,000 deaths are caused by food-borne illnesses and about 48 million people, or one in six Americans, gets ill from tainted food.
And the "official" numbers for those sickened and killed during foodborne disease outbreaks is considered a low-ball number, since not all foodborne illnesses--and even deaths--can be accurately tracked during major outbreaks.
“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," Kimbrell said. "The American people shouldn’t have to wait another second for safer food policies that are already law.”
Download the court filing here [PDF].
The science-based and prevention-oriented FSMA received final Congressional approval on Dec. 21, 2010, after more than eighteen months of battle.
Click here for a summary of the legislation.
*Photo by Pete Souza/White House