Berne, August 30, 2002

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  our ref.: zim / \# 332412.1

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**Comments submitted by the Swiss Government on the *Public Health
Security and Bioterrorism Preparedness and Response Act of 2002
(PL107-188)***

Dear Sir or Madam

Through the Swiss Embassy in Washington we have learned that FDA will
propose and issue regulations on the implementation of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002
(PL107-188), which was signed into law by the U.S. President on June 12,
2002. The Swiss authorities have also been provided with background
information on the issue as well as your request for initial comments.\
Since the new regulations may have a significant impact on international
trade in food, Switzerland considers it important to submit initial
comments on the provisions in Title III, Subtitle A (Protection of Food
Supply) at this early stage. It is our understanding that based on the
comments received, the FDA will draft and publish proposed regulations
by the end of this calendar year, offering a subsequent 60-day comment
period and will thus notify the proposed regulations under the
appropriate WTO Agreements.

**General Observations**

As outlined above, Switzerland is concerned that the new regulations may
have a significant impact on international trade in food. Acknowledging
that the WTO provisions allow countries to take measures necessary to
protect human, animal or plant life or health, we would like to stress
the importance of these measures being consistent with the fundamental
principle of non-discrimination and of them not constituting any
disguised restriction to international trade.

Furthermore, when taking measures which bear the potential of negative
interference with trade, care should be taken to chose the least trade
restrictive option available, taking into account the risks
non-fulfilment would create.

**Subtitle A -- Protection of Food Supply**

Sec. 305 Registration of Food Facilities

This section requires that for foreign food facilities registration must
include the name of the U.S. agent for the respective facility. We are
wondering whether it is a new requirement to have an U.S. agent or
whether this provision has been part of the food import requirements
already.

Registrants will have to notify the Secretary in a timely manner of any
changes to the registration information. This requirement implies that
the registration will be valid until withdrawn by the registrant, a
concept that we would support.

The definition of facility includes factories, warehouses or
establishments of an importer that manufactures, processes, packs or
holds food. With respect to the term "warehouse" we are concerned that
this term might be too inclusive. We, therefore, suggest that only
independent warehouses be subject to the registration requirement but
not warehouses which are part of a factory or another establishment that
is subject to registration.

Furthermore, Section 305 authorizes the Secretary to provide for and to
encourage the use of electronic methods of registration. We would
strongly support an efficient registration system which uses electronic
methods of registration. Considering that all changes to the information
must be notified to the Secretary in due course, on-line registration
and the possibility for on-line update of registered information would
reduce the administrative burden on both sides.

With respect to the new registration requirement, we are of the opinion
that all necessary registration forms as well as the rules on how to
complete the forms should be made available in the languages of the
trading partners.

Section 305 is supposed to amend Section 301 to make failure to register
a prohibited act. Considering that any food shipment, which has not been
registered will be denied entry until registration has been completed,
we are of the opinion that failure to register should not be subject to
additional sanction.

Sec. 306 Maintenance and Inspection of Records for Foods

This section requires record keeping for facilities. It is our
understanding that this record keeping requirement would be limited to
information necessary to determine the immediate previous sources and
the immediate subsequent recipients of food. With respect to foreign
facilities should be noted that the registration requirement is limited
to those who manufacture, process, pack or hold food if food from such
facility is exported to the U.S. without further processing or packaging
outside the U.S. Consequently the "traceability system" may not use the
registration number of facilities as a basis for the record keeping.

When there is a reasonable belief that an article of food is adulterated
and hence presents a threat of serious adverse health consequences or
death to humans or animals, the Secretary shall be authorised to have
access to certain records. While we understand that this provision does
not cause any problem on national level, we would like to draw attention
to the fact that government acts executed by foreign authorities on
Swiss territory constitute a violation of sovereignty and are,
therefore, prohibited. Access to records of Swiss facilities would
require administrative assistance by Swiss authorities.

With regard to the information which has to be disclosed to authorities
we would like to stress the importance of restricting information
requests to data which are indispensable for the specific investigation.
Confidential business information such as recipes and know-how relating
to manufacturing or processing or any other information that could be
covered by the obligation of professional secrecy should at no times be
subject to a disclosure requirement.

Sec. 307 Prior Notice of Imported Food Shipments

With regard to the requirement to provide prior notification for
imported food shipments, Switzerland questions the contribution of this
requirement to the stated food safety objective. Since all facilities,
whether exporting or importing to the U.S., are subject to registration
it seems doubtful to us that this prior notice adds any information on
the imported food which would be necessary to ensure the safety of the
shipments or facilitate product recalls. In our view this requirement
constitutes a disproportionate administrative burden, which in addition,
is being applied unequally to foreign and domestic facilities.

With respect to the information that must be included in the prior
notice of food shipments we would like to note that since the record
keeping for registered facilities requires product tracing one step
forward and one step backward, some of the required information (i.e.
grower) may not be available. With respect to the requirement to
indicate the country of origin we were wondering whether this
requirement would take up the country of origin concept as used for
customs matters or would instead adopt the "country of origin"
provisions of the Codex Alimentarius General Standard on Food
Labelling[^1].

With regard to the practical implementation of the "prior notice"
requirement Switzerland fears that administrative procedures would
subject admission of the goods to unnecessary delays. Since a number of
foodstuffs are perishable such delays would seriously affect imports.

A further requirement states that if prior notice is not provided, the
articles shall be refused admission. With respect to this provision, we
are afraid that the decision to grant admission will be based on the
fact that the "prior notice" has been received by the U.S. authorities.
This means that the risk of failure in transmission will be born by the
exporting facility, which in our view once more adds a burden to foreign
facilities which domestic facilities do not have.

Sec. 303 Administrative Detention

Detention may be ordered if there is credible evidence or information
indicating that the article presents a threat of serious adverse health
consequences or death to humans or animals. Switzerland is interested in
the exact criteria for such judgement and believes that the
evidence/information on which the detention decision is taken, will have
to be disclosed to the exporting facility since this information is
essential for any appeal procedure.

The Swiss authorities would like to thank the FDA for giving due
consideration to its comments and to the potential impact of the new
regulations on international trade in food in general. Please do not
hesitate to contact us if you have any questions.\
May we kindly ask you to keep us informed with respect to the further
procedure on this issue and to provide us with the draft proposal as
soon as it is available?

Yours sincerely,

**State Secretariat for Economic Affairs**

Sectoral Policy Issues

Heinz Hertig

Head Non-tariff Measures Division

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| copy:    | \- Swiss Embassy, Washington                              |
|          |                                                           |
|          | \- U.S. Embassy, Bern                                     |
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[^1]: CODEX STAN 1-1985 (REV.1-1991)