FDA issues final rule on prior notice of imports - The Packer

FDA issues final rule on prior notice of imports

05/29/2013 11:06:00 AM
Coral Beach

The Food and Drug Administration’s rule on mandating notice if a food has been rejected by another country before being sent to the U.S. is official.

The “prior notice of imported foods” rule has been in effect since May 2011, when the agency released it as an interim rule, but it becomes official when it appears in the Federal Register, which is scheduled for May 30.

The final rule is identical to the interim rule, according to a notice issued May 29 by the FDA.

Required by the Food Safety Modernization Act, the rule says that any person submitting a prior notice for imported food include whether the food was refused entry to any other country.

According to the FDA’s notice, it received 15 comments on the prior notice rule. Several comments asked for a clarification of terms, including “refused entry.” FDA officials said it covers any refusal based on food safety reasons, including intentional or unintentional contamination.

“... only refusals for food safety reasons should be reported,” according to the FDA.

One commenter said it is unreasonable for FDA to hold importers liable for what could later be found to be a false declaration if they were unaware that food had been refused entry by another country. FDA’s response cited language from the rule that states “prior notice must be submitted by a person with knowledge of the required information.”

Another rule — detailing the FDA’s power of administrative detention of food based on belief, not evidence, that it has been adulterated or misbranded — became official in February.

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