FDA revises compliance for prior notice of food imports
The U.S. Food and Drug Administration (FDA) and Customs and Border Protection are still experiencing numerous technical problems when food importers file their prior notices to the agencies.
The agencies have found persistent problems with certain data elements in the prior notices, such as registration numbers, bill of lading numbers, and ultimate consignees.
“In part, these problems result from a lack of standardization,” the FDA said. “The problems also arose due to the practical difficulties faced by submitters in obtaining required information in complex commercial settings.”
Thus, the FDA and Customs plan to refrain from regulatory action prior to Nov. 1, 2004, related to:
* Inaccurate or invalid manufacturing facility registration numbers.
* Missing shipper registration numbers.
* Missing or invalid airway bill or bill of lading numbers.
* Inaccurate consignee name due to listing of express carrier as consignee.
The FDA warned, however, that if the violations reflect a history of wrongdoing by the food importer, Customs could issue civil monetary penalties against that company.
The agency also said regulatory action won’t be taken against food shipments used in research if they’re found to lack a manufacturing facility registration number.
The FDA’s prior notice rules for food imports were implemented under the 2002 Public Health Security and Bioterrorism Preparedness and Response Act.
The FDA and Customs have also revised their plan to begin integration of the prior notice procedures with the timeframes for advance notices of arrival for shipments handled by truck, rail and airline from Nov. 1 to Jan. 3. A final prior notice rulemaking for these transport modes is due by June 2005, the FDA said.