FDA Issues Final Rule Requiring Prior Notices Be Submitted Within Specified Time Frame
The FDA issued a final rule Sept. 25 that will set a 10-day deadline for submissions of prior notices for food shipments refused because of no prior notice or an inaccurate one, and a 30-day deadline for submissions of food facility registrations (FFR) for shipments held because a facility is unregistered. The changes take effect Oct. 27.
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The final rule also adds new requirements for international mail, requiring additional data and providing additional filing options.
Previously, the regulations specified that food shipments refused for lack of an adequate prior notice or held because of an unregistered facility could be treated as general order merchandise if no prior notice or registration is subsequently submitted, but they included no timeline for that submission.
"Requiring a reasonable timeframe for post-refusal and post-hold submissions of prior notice and FFR may reduce the amount of time articles subject to refusal or holds are held at ports of entry, thus reducing associated monetary charges," the FDA said. "It will also enable FDA to utilize its resources more effectively by delineating the post-refusal and post-hold submission timeframe."
"Without a date by which such submissions must be made, FDA has spent long periods of time (e.g., weeks and months) reviewing multiple replacement non-compliant prior notice or registration submissions," the agency continued.
In addition to these changes, the FDA made some revisions to regulations governing food arriving by international mail, as well as some technical changes.
Beginning Oct. 1, 2026, there will be a requirement that the prior notice for articles of food arriving by international mail should include the name of the mail service and a tracking number.
"To effectively carry out its responsibility to detect food articles offered for import that are adulterated or pose a public health risk, FDA must be able to identify and inspect food items that are imported by international mail," the agency said. "Receiving the name of the mail service and a mail tracking number for articles of food arriving by international mail will enable FDA to better coordinate with the U.S. Postal Service (USPS), U.S. Customs and Border Protection (CBP), and other Agencies to track and inspect articles that have been identified as a possible bioterrorism risk."
The FDA continued: "Currently, FDA does not receive the name of the mail service or tracking numbers for articles of food arriving by international mail. This makes it difficult for FDA to stop articles from being delivered to U.S. recipients that FDA believes pose a bioterrorism risk. Having the name of the mail service and tracking numbers for articles of food arriving by international mail will help FDA better plan its operations and stop such articles from being delivered."
Meanwhile, the technical changes are meant to reflect expanded capabilities of the Automated Broker Interface/Automated Commercial Environment/International Trade Data System (ABI/ACE/ITDS) and the Prior Notice Systems Interface (PNSI), the FDA said. An amendment removes the requirement that prior notice of imported food arriving by international mail be submitted exclusively through the FDA's PNSI. Now, prior notice may be submitted either through the PNSI or through ACE.