US is aiming to strengthen its oversight of foods entering the US

In the US, the Food and Drug Administration (FDA) is hoping to implement rules that will make food processors exporting food to the US more accountable for food safety and will establish standards for third-party audits of foreign food producers. These proposals will strengthen the FDA’s ability to monitor those facilities and respond if there are unsafe practices.

Currently, the US imports around 15% of its food - including nearly 50% of fresh fruit and 20% of fresh vegetables.

The FDA has proposed two rules that represent a fundamental shift in its oversight of imported foods. The shift is designed to help prevent safety problems before those foods arrive in the United States, rather than having to rely primarily on inspections at US ports of entry.

The proposed Foreign Supplier Verification and Accredited Third Party Certification rules are the next major steps in implementing the FDA Food Safety Modernization Act signed by President Obama in 2011. The law calls for science-based changes to the food safety system to prevent foodborne illnesses.

The new rules will complement two others proposed in January 2013. The proposed Preventive Controls for Human Food rule will set safety requirements for facilities that process, package or store food for people. And the proposed Produce Safety rule will establish science-based standards for the safe growing, harvesting, packing and holding of produce on farms.

Foreign supplier verification

Brian Pendleton, JD, a senior policy advisor at FDA, explains that the import rules build on the two FSMA rules proposed earlier. “It’s a way to ensure that imports meet US safety standards,” he says. “It’s all part of a multipronged effort to improve the safety of both domestic and imported foods."

The proposed rule will require importers to perform certain activities, generally based on hazards identified as reasonably likely to occur with a food. Importers will have to establish that the foods being exported to the United States have been produced in a manner consistent with US standards. In general, it would require that importers:

• identify hazards associated with each food;
• conduct or obtain documentation of verification activities, which could include on-site auditing, sampling and testing, to provide adequate assurances that the identified hazards are being controlled; and
• take appropriate corrective action if hazards are not being adequately controlled.

“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,” says Michael R Taylor, JD, deputy commissioner for foods and veterinary medicine.

Accredited third-party audits and certification

This proposed rule would establish a system for the recognition of foreign government agencies or private companies that would accredit third-party auditors of foreign food facilities. These auditors would conduct food safety audits and issue certifications that FDA may use in deciding whether to admit certain imported food into the US that the agency has determined poses a food safety risk.

Both accreditation bodies and auditors would have to meet standards established by FDA to help ensure the quality and credibility of audits in this program.

Charlotte Christin, JD, a senior policy advisor at FDA, explains that an audit is a comprehensive assessment of a food-producing operation. Under the proposed system, the reports of audits used for certification purposes would be submitted to FDA.

FDA would be closely monitoring these systems and could revoke an accreditation body’s recognition or withdraw an auditor’s accreditation for good cause, says Christin. “Accountability is key to the success of the program,” she says.

Next steps

The proposed rules have been published in the Federal Register, with a 120-day public-comment period. The rules are filed in FDA’s official docket at www.regulations.gov and can also be accessed at www.fda.gov/fsma.

Still to come is the Preventive Controls for Animal Food rule, which would implement preventive controls at animal food facilities that are similar to those proposed for human food.

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