Two consumer groups are stepping up their criticism of delays in implementing the Food Safety Modernization Act by suing the Office of Management and Budget and the Food and Drug Administration.
The lawsuit, filed on Aug. 30 in the U.S. District Court of Northern California by the Center for Food Safety and the Center for Environmental Health, says the FSMA “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.”
President Obama signed the bill into law in January 2011, but no major provisions have been established. The FDA sent several proposed regulations to the OMB last December, but none have been released or published in the Federal Register.
The groups want the court to order the FDA to enact regulations by a set deadline. It is normal practice for proposed regulations to be sent by agencies to the OMB for review, but the two consumer groups note the FDA has the legal authority to implement such rules on its own.
A representative for the Center for Food Safety speculated the OMB doesn’t want to give Republicans an election weapon to point to the food safety rules as job-killers. Republican vice presidential nominee Paul Ryan was one of only a handful of House members who didn’t vote for the bill in 2010.
“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 the 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.”
Food industry groups lobbied for several years in favor of the bill, and with one exception have not mounted an attack on any proposed rules under discussion.
The foreign supplier verification program, which makes importers legally responsible for the safety of imported foods, is not disputed in general. Some industry group, however, did take issue with an FDA proposal for the imposition of reinspection fees on some imported shipments.
They argued that the FDA’s definition of a reinspection was overly broad and would be too costly and burdensome for importers.
The lawsuit comes on the heels of a spate of recalls of tainted food, including domestic cantaloupes and papayas imported from Mexico.
“This unreasonable and dangerous political foot-dragging on FSMA has to stop now,” said Charles Margulis, food program director at the 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.”
Some food suppliers and importers and industry groups are eager for the new regulations because they say they would level the playing field between cut-rate bad actors and responsible companies.
In all, the FDA has failed to promulgate seven major food safety regulations, according to the lawsuit. The key rules under review — preventive 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 been in the rule-making process or have been implemented by now and, the complaint points out, there are at least nine more FSMA deadlines in early 2013.
Without regulations in place, companies face uncertainty, said Mark FeDuke, director of trade compliance for VLM Foods. “In the end, the industry is left to gauge what is needed with some very big question marks out there,” he said. “What is clear is that there will be a new focus on preventive controls. Good companies are already working on that.”
Importers will be held to increasingly high levels of accountability for the safety and wholesomeness of food brought into the U.S. “If you are a responsible company, you are already looking to see the holes in your system.”
Responsible food importers “appreciate having a strong food safety regulator in place with regulations that are clear and predictable,” FeDuke said. “That means the regulator will be able to go after those folks that right now aren’t spending the money to adhere to the best practices in the industry.”
One item FeDuke and others are very interested in having the FDA put in place: a trusted trader and voluntary qualified importer program. “If you are going above and beyond regulations and the law,” he said, “there should be benefits.”
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