- FDA Public Meeting, May 7, 2003, on Proposed Bioterrorism Regs.

From: Pamela Tom (pdtom@ucdavis.edu)
Date: Wed Apr 09 2003 - 13:35:41 PDT

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    Fr: Pamela Tom, University of California, Sea Grant Extension Program

    The U.S. Food and Drug Administration will hold a public meeting (via
    satellite downlink) on May 7, 2003 (10 am - noon, PDT) to discuss proposed
    regulations implementing two sections in the Bioterrorism Act regarding:

    Section 303 - Administrative Detention, and
    Section 306 - Maintenance and Inspection of Records for Foods

    The purpose of the satellite downlink public meeting is to provide
    information on the proposed rules to the public and to provide the public
    an opportunity to ask questions or to provide coment.

    U.S. viewing locations are in the Federal Register:
    http://www.cfsan.fda.gov/~lrd/fr030408.html

    ==========================================================================
    FOR THE LATEST INFORMATION ON FDA'S BIOTERRORISM LEGISLATION:

    To keep informed on recent developments with the implementation of the
    Bioterrorism Act and your responsibilities in registering your facility,
    shipping product into the U.S., record maintenance, and understanding of
    detention procedures, you may want to bookmark and visit these two FDA
    websites:

    The Bioterrorism Act of 2002:
    http://www.fda.gov/oc/bioterrorism/bioact.html

    FDA Actions on New Bioterrorism Legislation:
    http://www.cfsan.fda.gov/~dms/fsbtact.html
    ===========================================================================
    BACKGROUND INFORMATION:

    The events of September 11, 2001, highlighted the need to enhance the
    security of the U.S. food supply. Congress responded by passing the
    Bioterrorism Act (Public Law 107-188), which was signed into law on June
    12, 2002. The Bioterrorism Act includes four provisions in Title III
    (Protecting Safety and Security of Food and Drug Supply), Subtitle A
    (Protection of Food Supply) that require the Secretary of Health and Human
    Services, through FDA, to develop implementing regulations on an expedited
    basis. These four provisions are:

    Section 305 (Registration of Food Facilities)*
    Section 307 (Prior Notice of Imported Food Shipments)**
    Section 306 (Maintenance and Inspection of Records for Foods)*** and
    Section 303 (Administrative Detention)****

    *FDA prefers electronic registration. Facilities may register as of
    October 12, 2003, and must register by December 12, 2003. (A proposed
    7-page form can be viewed at:
    http://www.fda.gov/oc/bioterrorism/bioact.html)

    **Implemented as of December 12, 2003. (A proposed 5-page form can be
    viewed at: http://www.fda.gov/oc/bioterrorism/bioact.html)

    ***Implemented as of December 12, 2003.

    ****No deadline specified for final regulation

    FACT SHEETS on the above requirements are AVAILABLE at:
    http://www.fda.gov/oc/bioterrorism/bioact.html

    During the satellite downlink public meeting, FDA will explain the
    proposed rules on maintenance and inspection of records for foods and
    administrative detention and will answer questions. The satellite downlink
    public meeting will be offered in English with simultaneous French and
    Spanish translation and will be simulcast live in English, French, and
    Spanish for North, Central, and South America (including Hawaii and
    Alaska). Details on the satellite downlink coordinates are available in
    the Federal Register: http://www.cfsan.fda.gov/~lrd/fr030408.html

    Video rebroadcasts will be played at several locations throughout the
    world. Dates and viewing times for the video rebroadcasts for Europe,
    Asia, Australia, New Zealand can be found on FDA's bioterrorism Web site
    (http://www.fda.gov/oc/bioterrorism/bioact.html).

    On January 29, 2003, FDA held a satellite downlink meeting during
    which FDA explained the proposed rules for registration of food
    facilities and prior notice of imported food shipments to implement
    sections 305 and 307 of the Bioterrorism Act, respectively. You may
    download a transcript or video of this program at:
    http://www.cfsan.fda.gov/~dms/fsbtact.html Check back at this address
    following the May 7 broadcast for a copy of the transcript and video.
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