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FDA Releases Two Major Rules to Boost Oversight of Imported Foods

Today the U.S. Food and Drug Administration is releasing two long-awaited rules aimed at improving the safety of imported foods, which now make up about 15 percent of the U.S. food supply.

The measures, mandated by the Food Safety Modernization Act, will require that importers verify their suppliers are employing prevention-based food safety practices and create a system for certifying third-party auditors. The agency is also extending the comment period for two other key rules, preventive controls and produce safety, another 60 days, beyond the current Sept. 16 deadline, to help stakeholders consider the proposals as a package.

The two new proposed regulations — Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors – would be a “huge sea change” for food safety, according to Michael Taylor, Deputy Commissioner for Foods and Veterinary Medicine at FDA, because they shift the regulatory system toward prevention, instead of relying heavily on FDA inspectors to catch problems at the border or port of entry.

According to FDA, the agency is only able to physically inspect about two percent of all of the food coming into the country. At some points in the year half of fresh fruits and 20 percent of fresh vegetables consumed in the U.S. come from abroad and FDA is eager to hold produce, and all foods, to the same FSMA standards that U.S. producers will soon be held to. The FDA estimates the verification programs alone will cost the food industry between $400 and 500 million annually.

In an interview, Taylor noted that many U.S. food importers are already meeting what will be required under the coming Foreign Supplier Verification Program, but the regulations will for the first time clearly define their responsibility. Importers will have to have a plan in place that identifies the potential hazards for each food they’re procuring, they will have to document what is being done to control the hazards, and FDA will have access to those documents.

“What’s not present in the current system, even for those doing the right thing, is public accountability,” said Taylor.

While foreign supplier verification is likely to get most of the attention, the Accreditation of Third-Party Auditors is also a key change as many in the food community look to improve the integrity and consistency of food safety audits. Under the rule, FDA would recognize accreditation bodies, which could be foreign governments , non-profits, or private companies, to accredit third-party auditors, which can then be used for certifying foreign food facilities and for food, in some cases.

According to the agency, importers will not be required to obtain such certifications, but the process might be used by FDA to determine whether to admit a particular imported that might pose a food safety risk.

Taylor said the agency hopes that in the future the accreditation system can be adopted more broadly by third-party auditors to “strengthen the integrity of the industry,” which has come under scrutiny in the wake of high-profile foodborne illness outbreaks caused by companies that had recently received exemplary audits.

Consumer and industry groups are pleased the proposed regulations are out so the process of implementing FSMA can keep moving.

“We are very pleased that implementation of FSMA is moving forward,” said the Grocery Manufacturers Association, in a statement. The group said it looks forward to working with the FDA “by continuing to share our food safety expertise and best practices and by evaluating and commenting on these and future proposed rules.”

Sandra Eskin, director of the food safety campaign at the Pew Charitable Trusts, called the new rules a “huge step forward.”

“We’re thrilled that we’ll finally get to read these proposals,” she said.

According to Pew, 8 of the 19 multistate foodborne illness outbreaks that have occurred since President Obama signed FSMA into law in January 2011 were linked to imported foods, including mangoes, tuna scrape, cucumbers, and other items. That number includes the current 9-state hepatitis A outbreak linked to pomegranate seeds imported from Turkey that has sickened 153 people, 66 of whom were hospitalized.

“The longer it takes to get these rules implemented, the more people will get sick who don’t need to get sick,” Eskin said.

When asked why the two new proposed rules took more than a year and a half to clear the White House Office of Management and Budget’s Office of Information and Regulatory Affairs, FDA’s Taylor would not name any particular sticking points.

He said the rules are particularly complex and the timeline is “not out of the ordinary.”

“What’s been impressive to me is how complicated it gets when you’re designing a new system,” he said. “And then you have to work out the intricacies of how [all the FSMA rules] work together.”

Some stakeholders have speculated that the concerns of foreign governments might have had a hand in the long review, as the rules would need to be carefully crafted with trade concerns and the United States’ World Trade Organization obligations in mind.

Ben England, former regulatory counsel at FDA and a founding member of FDAimports.com, said he thinks that there is going to be intense push back from the international community on the new proposals.

“These regulations are going to be ugly,” said England, who served at FDA for 17 years, but now advises a variety of import clients. While he thinks the idea of foreign supplier verification makes sense, England believes the way Congress outlined the program is problematic because it doesn’t recognize the complexity of the global food system.

Many food companies shipping food to the U.S., for example, are sourcing ingredients from all over the world. In that case, it’s very doubtful FDA would be able to regulate so many steps up the supply chain, according to England.

“There will be international resistance to FDA reaching their fingers all the way up the supply chain, across multiple supply chains in multiple countries,” he said.

Both proposals, which are around 200 pages each, will be posted to the federal register today and stakeholders will be given 120 days to comment on them. Taylor told Food Safety News that the new 60-day extension of the comment period for preventive controls and produce safety, which comes after another extension issued in April, will be the last.

As Food Safety News has reported, the implementation of FSMA has been severely behind the schedule mandated by Congress and the FDA is now under court order to publish all rules required by FSMA by mid-2015.

This article has been updated to include links to the proposed rules, estimated costs, and inspection numbers.

© Food Safety News
  • Fran Washington

    WOW! Bravo USA/FDA. We were dying to get this done. Again, BRAVO.

  • http://www.fairtradefish.org/ SenorPescador

    as i have indicated we will be more than happy to be overindulgent in food safety, we want retutn clients and the safety of people is most important over profits

  • William

    if the fda enforce this as poorly as they do everything else it will useless!