Overview of Operational – Components of Prior Notice

ORA OPERATIONAL – OVERVIEW

  • Prior Notice is a «Reporting» requirement
    • Not an [801(a)]Admissibility Requirement
  • Components of Prior Notice
    • Receipt
    • Review
    • Response

Components of Prior Notice

  • Receipt
  • ABI/ACS
  • PNSI
  • Email/Fax (Contingency ONLY)
  • Review
  • Prior Notice review will occur in a Central Location (not local FDA Districts)
  • Prior Notice review will occur 24/7
  • Prior Notice review will be separate from, and occur prior to, [801(a)] admissibility review
  • Response
  • PN review will determine what shipments require a response at the border
  • Response will be accomplished by either FDA or CBP – depending on the port and time of arrival
  • Response may consist of:
  • Cargo examination/verification
  • Sample collection
  • Direction of shipment to a secure facility or storage at the port of arrival or port of entry if PN is inadequate
  • Admissibility of Cargo

    • Admissibility is determined as per Section 801(a) of the FFD&CA
    • Admissibility of cargo will continue to be determined at local FDA offices
    • Admissibility decisions will be made after Prior Notice requirements have been met

    Screening of International Mail

    International mail will be screened by CBP as follows:

    • Food mailings without a Prior Notice confirmation number on the declaration will be identified
      • Packages with return addresses may be returned to sender
    • Packages without return addresses and containing only food, may be destroyed at FDA expense
      • «Mixed» packages without return addresses may have the food products removed, a form letter inserted, and sent to addressee

    Enforcement of Prior Notice

    • FDA plans to exercise enforcement discretion for over first several months after Prior Notice goes into effect


    For Further Information . . .