U.S. FDA update on Implementing Enforcement of Prior Notice

From: Pamela Tom (pdtom@ucdavis.edu)
Date: Mon May 24 2004 - 22:16:54 PDT

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    To: Seafood Community

    The following information will be of interest to people involved with
    imported foods to the U.S. and prior notice.

    Pamela Tom, Univ. of Calif. - Sea Grant Extension Program
    ======================================================================
    Status of Implementing Phase 3 Enforcement of Prior Notice

    Due to a delay in implementation of software changes to Customs and Border
    Protection's (CBP) Automated Broker Interface (ABI) of the Automated
    Commercial System (ACS), CBP and FDA will implement Phase 3 of Enforcement
    of 21 CFR 1.283(a) and 1.285(a), (b) in June 2004.

    On May 18, 2004, in an Administrative Message entitled "DELAY
    IMPLEMENTATION STAGE 3 BIOTERRORISM ACT ENFORCMNT", CBP notified ABI
    filers that it was delaying the installation of programming changes for
    enforcement of the prior notice bioterrorism. These changes would have
    made failure to submit all mandatory prior notice (PN) data elements cause
    for rejection by ABI.

    This delay does not imply an automatic delay of the final stage of
    enforcement of prior notice requirements on August 12, 2004. Submitters
    and transmitters of prior notice should also realize that prior notice
    submission periods before the shipment arrival should take into account
    any possible time needed to deal with corrections required by either ABI
    or by FDA. Simply submitting prior notice within the minimum 2, 4, or 8
    hour window may not allow time to review, correct, and submit corrected
    prior notice sufficiently in advance of arrival to avoid refusal from FDA.

    FDA will soon publish a revised Compliance Policy Guide (Prior Notice of
    Imported Food Under the Public Health Security and Bioterrorism
    Preparedness and Response Act of 2002) implementing this date change for
    enforcement.

    Source: http://www.cfsan.fda.gov/~dms/fssupd88.html

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