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New FSMA import provisions explored during United Fresh webinar

WASHINGTON — Importers of certain fresh produce exempted from the Food & Drug Administration's new produce-safety proposal are not off the hook from complying with the Foreign Supplier Verification Program, cautioned Brian Pendleton, senior policy adviser at the FDA, during a United Fresh Produce Association-sponsored webinar held Sept. 3.

This was just one of many wide-ranging questions Pendleton and Charlotte Christin, another FDA senior policy adviser, fielded during a 90-minute webinar on the FDA Food Safety Modernization Act rules proposed on July 26.

The two officials from FDA's Office of Commissioner have been busy in recent weeks explaining the far-reaching Foreign Supplier Verification Program and third-party audit accreditation proposals to industry audiences.

The FDA is proposing certain exemptions from the produce rule, such as a commodity rarely consumed raw, a commodity destined for commercial processing or a commodity produced by a small farm.

Even if those exemptions applied, the statute directs the importer to ensure a shipment is not misbranded for allergen labeling or adulterated in order to meet the new FSVP, Pendleton said.

Several questions touched on a new requirement in FSMA that allows the FDA to mandate that suppliers obtain a certification for so-called high-risk foods or be denied entry into the United States.

This provision in the law went into effect in 2011 but the FDA has yet to use it.

"The agency is carefully considering this authority," Christin said.

However, there was no indication when or if the FDA would issue a guidance document to industry on this important provision.

One attendee inquired about the difficulty of requiring importers to gain assurances from many customers that they are controlling for hazards, a provision of FSVP.

Pendleton said the FDA is interested in hearing comments about any provision that may impose a hardship or is infeasible, but then added that if a customer is doing something to control for hazards, "you ought to know about it."

Many questions focused on the definition of importer. An importer of food under the proposed FSVP regulations is the U.S. owner or consignee of the food at the time of entry, or, if there is no U.S. owner or consignee, the U.S. agent or representative of the foreign owner or consignee.

But the FDA officials could not answer all the scenarios United Fresh attendees offered in what David Gombas, senior vice president of food safety and technology and moderator of the webinar, called "the gray areas" of the law that still need to be thought through at FDA.

For example, would produce items shipped to conventions for exhibits be required to comply with FSVP? Is the convention now the responsible importer?

Pendleton said he was not familiar with that type of scenario and that the law defines importer as whoever has ownership at the time of entry.

It's the industry's responsibility to come with questions and to offer solutions during the comment period, Gombas replied.

Comments are due on the two proposals by Nov. 26, and the FDA is holding its first of three public hearings in Washington, DC, on Sept. 19-20.