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FDA, Customs Agency Revise Prior Notice Rule
September 13, 2004
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FDA, Customs Agency Revise Prior Notice Rule
WASHINGTONThe Food and DrugAdministration (FDA) and the U.S. Customs and Border Protection (CBP) issued arevised compliance policy guide Aug. 12 describing their strategy for enforcingthe requirements of the prior notice interim final rule while maintaining anuninterrupted flow of food imports.
The agencies also announced a three month delay in theprojected date for issuing the prior notice final rule from March 2005 to June2005.
Under the revised compliance policy guide, the agencies beganenforcing fully all provisions of the prior notice rule on Aug. 13, except forthe following violations:
Registration number submitted for the manufacturingfacility is inaccurate or invalid;
Registration number for the shipper is not provided;
The Airway Bill number of Bill of Landing number is notprovided or is invalid; or
The name and address of the ultimate consignee isinaccurate because it contains the name and address of the express consignmentoperator or consolidator instead of the ultimate consignee.
For the above violations, the agencies announced they willcontinue to exercise enforcement discretion until Nov. 1, unless the violationreflects a history of similar conduct.
The prior notice provision in the Bioterrorism Act providesFDA (www.fda.gov) with advance information about imported food shipments.
Since February 2004, the agency has been receivingapproximately 160,000 prior notice submissions per week.
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