Questions for consideration during the satellite downlink public meeting
on the two interim final rules for the Bioterrorism Act to be held on
Tuesday, 28 October 2003.

***[Facility Registration]{.smallcaps}***

-   The interim rule for Facility Registration indicates on page 16 that
    the FDA will hold international outreach activities for US trading
    partners. What international outreach activities are being planned?

-   Comment/response 17 (pages 28-9) indicates that the
    manufacturer/processor needs to register, along with every facility
    that subsequently engages in packing or holding 'the beans', and any
    facility the subsequently engages in "de minimis"
    manufacturing/processing. In addition, FDA's comment/response 26
    (page 32-3), states that de minimis activity does not involve the
    direct manipulation of food. However the FDA's response to comment
    10 (page 25), states that the interim final rule requires only the
    last manufacturer/processor, including those that package food, to
    register. Surely facilities that package foods in a non de minimis
    manner are the "last" manufacturer/processor, thus any previous
    manufacturer/processors of the beans need not register. We seek
    clarification on this issue.

-   We request further clarification of de minimis activity. Could you
    provide examples of de minimis activity?

-   We seek clarification on whether quarantine/customs bond stores and
    inspection facilities are required to register.

-   Are facilities that store food that is being trans-shipped through
    Australia required to be registered with the FDA?

-   Airlines receive goods (including food) destined for export to the
    USA into their cargo terminals. These goods may be pre-packed (eg
    into cargo load devices (ULDs) or on pallets), or may be loose and
    require packing into ULDs. Is it necessary that each cargo terminal
    be registered?

-   To what extent is the Australian exporter liable for penalties if
    its US agent is negligent in performance of its duty as a
    communication link (including for emergency purposes) between the
    FDA and the exporter?

-   Can the US FDA provide a list of whom it considers to be suitable US
    agents for the purposes of meeting the requirements of the US
    Bioterrorism Act Facility Registration Regulation?

-   Does FDA have any contingency plans in place to avoid trade
    disruptions occurring on or after 12 December 2003 in case the
    electronic registration system is not as efficient as expected?

-   Does FDA have any contingency plans for handling a greater than
    anticipated number of facility registrations? (ie where FDA greatly
    under-estimates the number of foreign facilities being required to
    register.)

-   Non-packer exporters, whilst owning food, do not store food in a
    facility. The non-packer exporter takes ownership of a food
    consignment once it is stored on board the carrier (eg ship) that
    conveys the food to the USA. As facility registration only applies
    to facilities we seek confirmation that non-packer exporters do not
    have to register with the FDA under the Bioterrorism Act, as they do
    not have (own) facilities to store food consignments.

***[Prior Notice]{.smallcaps}***

-   Assuming non-packer exporters do not register with the FDA, what are
    the Prior Notice obligations for this type of food trader?

-   The interim final rule for Prior Notice to Import states that postal
    items containing food which do not have evidence of Prior Notice
    will be refused admission into the USA. What will be the disposition
    of mail without Prior Notice? Would it be the responsibility of the
    US postal service?

-   International airlines use food supplies kept in storage (in USA)
    under bond until they are loaded onto a flight for use in-flight.
    Similarly, unused and part used bottles of alcohol, soft drink and
    water are unpacked into a bonded kitchen for future intended re-use
    on subsequent international flights leaving the USA. All used and
    unused food goes to waste within the bonded kitchen. Do Prior Notice
    requirements apply in these circumstances where the food is stored
    under bond in the USA but is either consumed in-flight on
    international airlines or discarded in the bonded kitchen.

-   How will FDA handle the scenario where a Prior Notice is submitted
    but the Notice lists a manufacturing/processing facility that has
    previously cancelled its registration, however, at the time of
    production the manufacturing/processing facility was legitimately
    registered with the FDA?

-   What will happen to goods if they are accidentally shipped without
    meeting these guidelines, i.e. can they be trans-shipped, etc?

-   The starting date for the new requirements - when exactly do the new
    requirements commence? For example, is it 00:01am on 12 December
    2003 in the Eastern USA and therefore late 11 December in the
    Western USA, or 00:01am on 12 December in the Eastern USA and then,
    few hours later, 00:01am on 12 December in the Western USA?

-   If Australian exporters anticipate arrival of the shipments in the
    US before 12 December, but flights/sea voyages are delayed, will FDA
    be able to process last minute prior notices without affecting these
    shipments?

-   Identification of the submitter, transmitter, and manufacturer -
    will FDA\'s PN System Interface provide guidance on formatting of
    this information? We are concerned that FDA\'s PN System Interface
    may only accept certain formatting, without providing guidance to
    the submitter, and this may cause problems with FDA\'s PN System
    Interface accepting and processing prior notice.

-   We are similarly concerned about the identification of the article
    of food.

-   Scope of the ruling - who should submit the Prior Notice?\
    We seek further clarification of products covered by the new
    requirements - which if any products, normally subject to the
    jurisdiction of the USDA under the Federal Meat Inspection Act/the
    Poultry Products Inspection Act or the Egg Products Inspection Act,
    will be also covered by the new requirements for plant registration
    and prior notice?

### Other Rules

-   Given that the implementation date for all the rules under the Act
    is 12 December 2003 when are the interim final rules for maintenance
    of records and administrative detention expected to be published?