![](media/image1.jpeg){width="2.0930555555555554in"
height="1.1625in"}Comments on the

Proposed Rulemaking of the

*US Public Health Security and Bioterrorism Preparedness and Response
Act of 2002*

\[Food Bio-terrorism Bill\]

March 18, 2003

350 Sparks St., Suite 605, Ottawa, Ontario K1R 7S8

Tel: (613) 722-1000 Fax: (613) 722-1404 Email: fpc@foodprocessors.ca

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The Food Processors of Canada (FPC) is pleased to have the opportunity
to provide the following comments to the United States Food and Drug
Administration (FDA) for consideration as they develop the regulations
required for the implementation of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism
Act). The FPC is a internationally respected business association
serving food industry executives on matters concerning trade, commerce
and manufacturing. The members of FPC own or manage Canadian food
processing companies who add value to inputs sourced from around the
world and service markets in 80 countries including the United States
and therefore affected by the final rules implemented by the FDA.

**Docket No. 02N-0278 Section 307 (Prior Notice)**

[Submission of Notice:]{.underline} Recommend that responsibility for
submitting prior notice be extended to the exporter in addition to the
U.S. purchaser, U.S. importer or a U.S. agent for the following reasons:

-   Exporters usually have control of their shipments to their customers
    since they negotiate delivery terms with their transporters.

-   Exporters complete all necessary export forms so it would be
    reasonable they would submit prior notice.

-   Although US purchasers and customers initiate importation, they do
    not necessarily have the resources nor want to manage the delivery
    status of all product arriving at their establishments.

-   If exporters have to submit prior notices to a U.S. Agent, this will
    further delay the prior notice since exporter will have to send the
    notice to their agent (customs broker for example), who will then
    have to submit prior notice to the FDA by noon the previous day.
    This will not only delay the information flow but create added costs
    for exporter since the importer/purchaser/agent will have to submit
    on their behalf.

[Notice by Noon:]{.underline} Recommend that land and cargo (train or
truck) notification is a minimum notice of two hours prior to entry for
the following reasons:

-   Not always known what will be shipped that far ahead of time

-   Most notices will have to be amended the day of shipping once exact
    contents are identified on the truck

-   Customs entry numbers are not supplied until the truck hits the
    border

-   Not always clear at what port the shipment will clear

-   Work load created by this will not be measurable until the system is
    in place

-   Will the FDA system be able to properly work without crashing

-   Unable to fulfill "rush orders"

-   No immediate contact with driver in case of break down, bad weather
    or other issues as of changes needed to entry

[Port of Entry:]{.underline} Allow flexibility to accommodate unforeseen
circumstances that may require a change in the port of entry or timing.
A change should not necessarily result in detention or in
re-notification that would initiate a new minimum time period

[Less than Load (LTL) Shipments:]{.underline} FDA needs to consider how
to accommodate LTL shipments where several notices arriving at FDA at
different times may relate to a single shipment arriving at a port of
entry.