FDA unveils rules to boost imported food safety

The US Food and Drug Administration (FDA) today proposed two new rules to enhance the safety of imported foods, expanding safety efforts beyond traditional inspector checks at ports and country borders.

At a media teleconference today, FDA Commissioner Margaret Hamburg, MD, called the proposals a major step forward in implementing the FDA Food Safety Modernization Act (FSMA), which was signed into law in early 2011, representing a major overhaul of the nation's food safety laws.

Today's move was welcomed by food safety groups, which have pressed the FDA about delays in FSMA rulemaking, and food industry groups, which said they look forward to contributing their input during the comment period.

The FDA says that although imported food accounts for about 15% of the nation's food supply, about 50% of the fruit that Americans' eat and 20% of the vegetables come from other countries.

Foreign supplier verification

One of the proposed rules, foreign supplier verification, requires importers to take certain steps to ensure that the products being exported have been produced on par with US standards. For example, the rule requires importers to identify hazards associated with each food, document verification activities such as on-site auditing or testing, and take corrective actions if hazards aren't adequately controlled.

Michael Taylor, JD, the FDA's deputy commissioner for foods and veterinary medicine, said the FDA will continue to check food at US borders, but for the first time importers will be held accountable for verifying in a way that's transparent to FDA that the food they import is safe.

The import safety measures come in the midst of a hepatitis A outbreak that state and federal officials have said is likely linked to contaminated pomegranate seeds from Turkey that were part of a frozen berry mix. Health officials also suspect that several recent Cylospora infections in Iowa, Nebraska, Texas, and as many as eight other states might be tied to imported produce.

Third-party audits and certification

The second rule, accredited third-party audits and certification, would establish a system to recognize foreign government agencies or private companies that would accredit third-party auditors of foreign food facilities. The groups would conduct food safety audits and issue certifications that the FDA could use to decide whether to admit certain imported food considered at higher risk into the United States.

Hamburg said some vulnerable commodities come from countries that have "less mature" regulatory oversight and farming production methods. She added that an exciting aspect of the proposed rules is that they emphasize new relationships and are designed to help build systems that work and are grounded on systems of prevention.

Months away from final form

Both rules were published in the Federal Register and have a 120-day public comment period. Taylor said it could take 12 to 18 months to finalize the rule, and then importers would be given a timeline to come into compliance.

Hamburg said: "Comments from stakeholders will be key to the shape of the final rule."

The FDA estimates that the verification part of the rules could cost the industry about $400 million to $500 million, Taylor said, but that the cost to producers will vary depending where they are with their food safety prevention measures.

When asked about federal budget resources that might be needed to implement the new rules, especially in light of sequestration constraints, Taylor said the FDA estimated this spring that $400 million to $450 million over 2012 funding would be needed to address food safety initiatives. He said that President Obama's 2014 budget includes $260 million, with additional resources proposed from industry user fees.

"That would take us a long way down the road," Taylor said.

Consumer groups weigh in

Caroline Smith DeWaal, food safety director of the Center for Science in the Public Interest (CSPI), said in a statement today that the FDA's long-delayed announcement that it is moving forward with regulations to boost the safety of imported foods will, if finalized, lead to safer foods.

She said both of the rules rely on private industry to take steps to check the safety of their products. "Supplier verification means that companies should know who they are buying from—not just their name and address, but their food safety practices."

"This system is backed up with third-party checks. When these rules are eventually implemented, they will, at long last, give the FDA strong tools to improve the safety of imported foods," DeWaal said.

The Consumer Federation of America (CFA) yesterday in a statement said it welcomed the FDA's release of the proposed rules, which it said have been under review by the Office of Management and Budget (OMB) for many months. The CFA said the OMB has yet to release a proposed rule addressing preventive controls for animal feed.

Chris Waldrop, director of the CFA's Food Safety Institute, said in the statement, "Assuring the safety of imported food is essential to help prevent foodborne illness and protect consumers. We look forward to reviewing the proposals carefully and providing comments to the agency."

Trade groups respond

The Grocery Manufacturers Association (GMA), a trade group that represents more than 300 food, beverage, and consumer product companies, said in a statement today that the two proposed rules represent another step forward in implementing the landmark food safety law. It said the two measures put new and enhanced requirements on foreign suppliers, and the accreditation of third-party auditors will help make imported food safer.

The two elements were part of a 2007 GMA proposal to boost the safety of imported foods, the group said.

"We are very pleased that implementation of FSMA is moving forward and look 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," the GMA said.

Bryan Silbermann, president and chief executive officer of the Produce Marketing Association (PMA), a trade group that represents global produce and floral suppliers, said in statement today that the PMA welcomes the release of the new rules for several reasons.

"First, we know food safety is a top priority for our global produce industry and the implications of these proposals are critically important to our members' businesses and to our overall objective of increasing produce consumption," he said. "It's important that these proposed rules are geared toward advancing produce safety in a meaningful way for industry members that also protects public health."

He said the PMA shared testimony with the FDA in February, requesting the release of the proposed supplier verification rule so it could gauge its impact alongside new produce rules proposed in January. The FDA has extended the comment period on the proposed produce rules.

"Food that's consumed in the US, 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," he 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."

See also:

Jul 26 FDA press release

Jul 26 CSPI press release

Jul 25 CFA statement

Jul 26 GMA statement

Jul 26 PMA statement

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