Coronavirus pandemic forces FDA to halt most foreign inspections

The U.S. Food and Drug Administration (FDA) announced on Tuesday, 10 March, it will suspend most foreign inspections through April due to the coronavirus pandemic, although in-person reviews for FDA-regulated products deemed “mission-critical” will be considered on an ongoing basis.

In a statement, FDA Commissioner of Food and Drugs Stephen M. Hahn said the agency made the decision after the U.S. State Department and the Centers for Disease Control and Prevention issued travel advisories and some foreign countries implemented travel restrictions as well.

Still, he said the agency has confidence in its ability to still oversee foreign facilities, including seafood processing plants, remotely using other methods.

“We are aware of how this action may impact other FDA responsibilities, including product application reviews,” he said. “We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.”

In lieu of on-site inspections, the FDA will look to take other actions to ensure the safety and quality of imported goods, which could include additional inspections, including product sampling, at the point of entry, Hahn said.

Agency officials will work with Customs and Border Protection to identify which products may need inspection. That would include goods from first-time importers as well as products from companies known to skirt federal regulations.

“We can refuse admission of products that fail sample testing or may violate other applicable legal requirements,” Hahn said.

As the country imports more than 90 percent of the seafood Americans consume, domestic producers and political leaders in key seafood producing states have called on the government to conduct more inspections of foreign products.

That included getting a 26 percent increase in the amount of money the FDA receives for foreign seafood processing plant inspections for the 2019 fiscal year budget. Congress approved that increase, which gave the FDA USD 15 million (EUR 13.4 million) for the inspections, in February 2019.

Last summer, a number of U.S. lieutenant governors passed a resolution calling for an inspection fee to be placed on seafood imports during their annual association’s meeting. The per-pound fee would range from USD 0.05 to USD 0.10 (EUR 0.04 to EUR 0.09), to be used for additional inspections at the point seafood products are harvested.

Photo courtesy of Wikimedia commons

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