FDA officials hear questions on finer points of food safety law

09/05/2013 04:43:00 PM
Tom Karst

Food and Drug Administration officials provided insight on proposed rules for foreign supplier verification programs and the accreditation of third-party auditors during a web seminar hosted by the United Fresh Produce Association.

FDA senior policy advisors Charlotte Christin and Brian Pendleton gave presentations on the proposed rule and took questions from the online audience during the 90-minute event Sept. 4. About 150 registered for the free web seminar, according to Ray Gilmer, vice president of issues management and communications for Washington, D.C.-based United Fresh.

Serving as moderator of the Sept. 4 online event, David Gombas, senior vice president for food safety and technology for the United Fresh Produce Association, Washington, D.C., spent more than 30 minutes in a question-and-answer session with the FDA officials.

The web seminar is available online at the United Fresh website.

One question was about how FDA’s Foreign Supplier Verification Program would determine importer responsibilities if foreign growers met exemptions under the Food Safety Modernization Act. For example, if growers sell less than $25,000 of food year or produce fruits or vegetable rarely consumed raw.

“In situations like that, what will the importer be responsible for verifying?” Gombas asked.

If neither the produce safety rule or the preventive control rules apply to certain foreign growers, the FDA’s Pendleton said the Foreign Supplier Verification Program calls on importers to take steps to make certain the food they import is not adulterated or misbranded with respect to allergen labeling.

Gombas also asked if the FDA planned to issue any guidelines about what kinds of hazards importers should account for if they have to conduct a hazard analysis of a foreign suppliers. Pendleton said the FDA will issue guidance to help importers comply with the regulation when the final rule is issued.

“We don’t intend to analyze all the hazards in all the possible foods, whether produce or other foods, in the manner we did with seafood,” he said. “We don’t have the resources to do that, but the proposal does talk about hazards that need to be addressed and the type of factors affecting whether a particular hazard is likely to occur in a particular food.”

In her presentation, the FDA’s Christin said importers would not generally be required to obtain certifications from third-party audits. However, she said the FDA would in some circumstances use third-party certifications in determining whether to admit certain imported food into the U.S. She said the FDA will determine, based on food safety law criteria, what food poses a risk.

Another possible reason for certification is to determine whether an importer is eligible to participate in the Voluntary Qualified Importer Program, she said.

Gombas asked how the FDA will select the foods required to have certification and how the industry will know what foods have been selected for greater scrutiny.

She said the FDA is considering its authority for to require certification.

“This authority to require certification went into effect upon enactment back in 2011; we have not used it to date and we are still working through the details on how and when we might use it,” she said.

Factors in requiring certification include type of food, its source and the food safety capacity of foreign governments.

Responding to a question from Gombas about the responsibilities of FDA accredited auditors, Christin said auditors are required to tell the FDA about potential serious food safety problems, whether they are performing a consultative audit or a regulatory audit.

Christin urged industry stakeholders to take part in the FDA’s public meeting on the proposed rules on Sept. 19-20 in Washington, D.C.

For questions about that meeting, contact Juanita Yates, FDA, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740, or call 240-402-1731 and e-mail Juanita.Yates@fda.hhs.gov.



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