The Food and Drug Administration on Friday unveiled new rules to combat safety threats in imported foods - an overhaul that represents a sea change in U.S. treatment of food shipped from other countries.
Draft regulations to be published Monday seek to prevent contaminated foods from entering the country through third-part audits and a new supplier verification program, rather then relying on inspections when products arrive at U.S. ports of entry.
The regulations were drafted in accordance with the Food Safety and Modernization Act (FSMA). The nation’s largest food safety update in 70 years, FSMA shifts the focus from responding to contamination to preventing it.
The FDA in January unveiled proposed rules for American-grown and produced food. The rules issued Friday are aimed at the 15 percent of the nation’s food supply that is imported. That includes roughly half of fresh fruit consumed in the U.S. and 20 percent of fresh vegetables.
"We must work toward global solutions to food safety so that whether you serve your family food grown locally or imported you can be confident that it is safe," FDA Commissioner Margaret A. Hamburg said.
If finalized as drafted, the plan would designate foreign government agencies or private companies deemed fit to accredit independent, third-party auditors of overseas food facilities. The auditors would be entrusted to issue certifications that FDA would use to decide what food is allowed onto U.S. shores.
The FDA would establish a set of standards that must be met by both the accrediting bodies and the auditors.
The regulations would also place new restrictions on food importers in the U.S. Importers would be required to identify specific risks for each food brought to the U.S. and obtain documentation of its safety through the audits, sampling and testing.
Importers would be obligated to take corrective action if any safety risks are uncovered.
"We will continue to check food at our borders. However, rather than relying almost entirely on FDA's investigators at the ports to detect and respond to food safety problems, importers would — for the first time — be held accountable for verifying, in a manner transparent to FDA, that the food they import is safe," said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.
The proposed regulations received positive feedback from both industry groups and food safety watchdogs.
The Produce Marketing Association (PMA) in February urged the FDA to issue the rules so they could be examined together with the January proposal, allowing businesses to determine the totality of the food safety law’s impact.
“The release and the coordinated comment periods of these proposals are evidence that FDA is listening to industry’s needs,” PMA president Bryan Silbermann said.
“Now, with many of the pieces in place, we’re in a position to effectively review and assess these proposed rules and provide FDA with thoughtful comments.”
The Center for Food Safety, which took the FDA to court over delays in implanting the FSMA, also viewed the proposal as a step forward.
“It shouldn’t take litigation for an agency to implement rules as ordered by Congress, but sometimes it’s necessary,” said George Kimbrell, senior attorney for the Center. “We are happy to see FDA moving in the right direction.”
The rules, totaling well over 300 pages, will be published in Monday’s Federal Register, starting the clock on a 120-day comment period.