FDA issues proposed rules focusing on imported food

Two more proposed rules relating to the Food Safety Modernization Act (FSMA) were released Friday by FDA. The rules focus on the safety of imported food, and are designed to insure that all food that comes into the United States meets the same safety standards as food produced domestically. A 120-day comment period for each of the rules is now underway.

Food importers would be required to verify that their foreign suppliers are implementing modern food safety practice and achieving the same levels of food safety as U.S. growers and processors.

FDA is also proposing rules to strengthen the effectiveness of foreign food safety audits, which many food companies and importers rely to help monitor food safety.

According to FDA, imported food comes into the U.S. from about 150 different countries and accounts for about 15 percent of the U.S. food supply, including about 50 percent of the fresh fruits and 20 percent of the fresh vegetables consumed by Americans.

Under the proposed regulations for Foreign Supplier Verification Programs (FSVP), U.S. importers would, for the first time, have a clearly defined responsibility to verify that their suppliers produce food to meet U.S. food safety requirements. In general, importers would be required to have a plan for imported food, including identifying hazards associated with each food that are reasonably likely to occur. Importers would be required to conduct activities that provide adequate assurances that these identified hazards are being adequately controlled.

FSMA also directs FDA to establish a program for the Accreditation of Third-Party Auditors for imported food. Under this proposed rule, FDA would recognize accreditation bodies based on certain criteria such as competency and impartiality. The accreditation bodies, which could be foreign government agencies or private companies, would in turn accredit third-party auditors to audit and issue certifications for foreign food facilities and food, under certain circumstances.

Produce industry leaders generally welcomed the new proposed rules.

“The rules for imported foods and third-party auditor accreditation will have a critically important role in the safety of fresh produce,” said Tom Stenzel, president and CEO of United Fresh. “United Fresh will immediately begin a comprehensive review of these new draft rules and work closely with FDA to ensure that they contribute to our mutual goal of continued food safety improvement.”

Since January of this year, United Fresh has conducted a full review of FDA’s proposed Produce Safety and Preventive Controls rules, bringing together member company experts from each segment of the produce supply chain. United said it will use that same process in the review of FDA’s draft rules on imports and third-party auditors to provide comments to FDA.

“Initially, we don’t see any surprises in FDA’s draft rules on imported foods and third-party auditor accreditation,” said David Gombas, senior vice president for food safety and technology. “However, it’s important that we thoughtfully review them in a line-by-line fashion, including analysis of their interaction with other FSMA draft rules, to ensure they advance food safety and are workable for the industry.”

The two new proposed rules are intended to advance produce safety in a meaningful way for the industry while protecting public health, said Produce Marketing Association President Bryan Silbermann.

“ … As part of our work with the FDA, we shared testimony with them earlier this year asking for the release of the proposed rule on foreign supplier verification programs so we could evaluate the proposals on produce and preventive controls concurrently,” Silbermann said. “Food that’s consumed in the U.S., no matter where it’s grown, must meet the same standards. The release and the coordinated comment periods of these proposals are evidence that FDA is listening to industry’s needs. 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 to assure that the final rules are practicable to implement, cost effective and enhance the safety of fresh produce regardless of where it is grown.”  

For the full text of the rules, visit here.