New FDA Rules (re: Bioterrorism Act of 2002) Announced

From: Pamela Tom (pdtom@ucdavis.edu)
Date: Fri Oct 10 2003 - 01:17:14 PDT

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    On October 9, 2003, HHS Secretary Tommy G. Thompson announced the issuance
    of two Food and Drug Administration (FDA) regulations that will bolster
    the safety and security of America's food supply. The new regulations
    will enable better targeted efforts to monitor and inspect imported foods
    and will allow quick identification and notification of food processors
    and other establishments involved in any deliberate or accidental
    contamination of food. These two new regulations will implement key
    provisions of the Public Health Security and Bioterrorism Preparedness and
    Response Act of 2002, which provided FDA with new authority to protect the
    nation's food supply against actual or threatened terrorism acts and other
    food-related emergencies. On October 28, 2003, FDA will hold a public
    meeting (via satellite downlink) to discuss these two final regulations. A
    list of open viewing sites for the satellite downlink is on the web at:
    http://www.fda.gov/cdrh/ohip/dcm/html/cfsan_open_sites.html

    International rebroadcast information is on the web at:
    http://www.fda.gov/cdrh/ohip/dcm/html/cfsan_event_page.html

    Copies of the Federal Register notices, fact sheets and related
    information about the final regulations on the Registration of Food
    Facilities and Prior Notice of Imported Food Shipments are available at:
    http://www.fda.gov/oc/bioterrorism/furls/

    The following site will be open on October 16, 2003 at 6:00 pm EDT for
    facility registration: http://www.fda.gov/furls
    The owner, operator, or agent in charge of a domestic or foreign facility
    that manufactures/processes, packs, or holds food for human or animal
    consumption in the U.S., or an individual authorized by one of them, must
    REGISTER that facility with FDA by DECEMBER 12, 2003. A domestic facility
    must register whether or not food from the facility enters interstate
    commerce. A foreign facility must designate a U.S. agent (for example a
    facility's importer or broker), who must live or maintain a place of
    business in the U.S. and be physically present in the U.S., for purposes
    of registration. (See http://www.cfsan.fda.gov/~dms/fsbtac12.html for
    further details.)

    Beginning on DECEMBER 12, 2003, PRIOR NOTICE must be received and
    confirmed electronically by FDA no more than 5 days before arrival and, as
    specified by the mode of transportation below, no fewer than:

    2 hours before arrival by land by road
    4 hours before arrival by air or by land by rail
    8 hours before arrival by water
    The time consistent with the timeframe established for the mode of
    transportation for an article of food carried by or otherwise accompanying
    an individual if it is subject to prior notice (The food must also be
    accompanied by the FDA confirmation.)

    In addition, prior notice must be received and confirmed electronically by
    FDA before food is mailed by international mail. (The parcel must be
    accompanied by confirmation of FDA receipt of prior notice.) (See
    http://www.cfsan.fda.gov/~dms/fsbtac13.html for further details.)

    Further information regarding the regulations is on the web at:
    http://www.fda.gov/oc/bioterrorism/bioact.html

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