JP/sh/1859

Peter Kurz Esq.

Minister-Counselor for Agricultural Affairs

United States Department of Agriculture

Embassy of the United States of America

24 Grosvenor Square, Box 48

London W1A 1AE *By fax: 0207 894 0031*

7 July 2003

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# Further Proposed Regulations under the US Bioterrorism Act (Section 303 administrative detention; docket no. 02N-0275 and Section 306 establishment and maintenance of records; docket no. 02N-0277)

Thank you for your letter of 23 April, detailing two further regulations
proposed under US bioterrorism legislation, Section 303 (administrative
detention) and Section 306 (establishment and maintenance of records).
The Food and Drink Federation FDF[^1] again welcomes the opportunity to
comment on these new proposals and trusts our previous comments on
Section 305 (registration of food facilities) and Section 307 (prior
notice), sent to you on 4 April, were useful.

Our trade with the US is of critical importance, with current trade
flows for food and drink approaching £1 billion a year in each
direction. Many of our leading member companies have significant links
and long-standing trading interests with the US and therefore wish to
work closely together with US authorities to ensure a safe and
commercially viable trading system for all concerned.

FDF shares the FDA's objective of protecting the safety and security of
food supplies, a fundamental requirement for our member companies.
However, whilst welcoming recent news that the FDA and US Customs and
Border Protection (CBP) will work together to streamline the
implementation of prior notice requirements (Section 307 docket number:
02N-0278), we remain deeply concerned at the impact the increasing
number of new regulations may have on trade, notably where these are
likely to add cost, delay and uncertainty for exporters to the US.

We consider that the proposed measures to be applied to food imports
into the US will impose heavy and costly burdens upon UK and other EU
exporters and will act as a clear non-tariff trade barrier. Small and
medium sized companies in particular risk being prevented from
continuing to export to the US, especially where the new regulations and
the administrative burdens imposed on them would render their exports
too costly to be economically viable.

Specifically regarding Sections 303 (administrative detention) and 306
(establishment and maintenance of records), FDF believe these
regulations to be overly bureaucratic and in some aspects an unnecessary
duplication of existing security measures. We also support the detailed
comments sent to you on these proposals by our sister federation, the
Grocery Manufacturers of America (GMA).

Section 303 is of particular concern to FDF as any detention of incoming
shipments at US borders would directly affect UK companies exporting to
America. Moreover, the Container Security Initiative (CSI) already
operates in five major UK ports. To facilitate the initiative, US CBP
officers are stationed alongside UK Customs personnel to enhance
co-operation in sharing of information and pre-screening of 'suspect'
containers before departure for the US. To this end we do not understand
why shipments traveling from the UK ports named above should be subject
to a second possible check and delay at US borders.

As outlined in our previous response of 4 April, FDF believes that
companies who participate in the US Customs Trade Partnership Against
Terrorism (C-TPAT) initiative (aimed at protecting global commerce from
terrorism) should be subject to reduced scrutiny by the FDA. This would
lessen the need for the detention of goods and the ensuing disruption of
shipments/delays in meeting customer orders. Known traders who, by
definition, are not considered a security risk to the supply chain
should also be able to benefit from reduced checks and inspections,
allowing US Customs to focus on those consignments which do not come
from "trusted" or reputable sources. Each of our member companies pride
themselves on their reputation as trusted traders.

FDF believes that the FDA has significantly underestimated the costs and
strategic requirements of applying this new legislation that is due to
come into force in less than 6 months time on 12 December 2003. To this
end we urge them to fully consider all industry comments on the proposed
regulations under the US Bioterrorism Act to ensure that such new laws
enhance rather than inhibit transatlantic trade flow and reduce, as far
as possible, the threat of terrorist intervention.

Finally, we are also seeking clarification regarding exemption from US
Bioterrorism Act regulations for small amounts of food product
(typically 100g-1kg) sent to the US as technical samples i.e. not for
human consumption at any stage. I enclose a more detailed account of the
situation at Annex 1.

I trust that you will find our comments helpful and we look forward to
being kept informed of further developments on this critical issue. We
are copying this letter to relevant officials from DGs Enterprise,
Agriculture, Trade and Sanco, US Mission to the EU and DEFRA.

# Jonathan Peel

Director, European and International Policy

<jpeel@fdf.org.uk>

**Annex 1 -- Exemption of technical samples from US Bioterrorism Act
regulations**

A number of FDF member companies periodically send technical food
samples to their US subsidiaries for evaluation. The samples may
comprise raw or semi/processed goods and are typically 100g to 1kg in
volume.

As the samples are used for evaluation purposes only, i.e. not further
processed into products for retail to general public or consumption by
human beings at any stage, **[FDF believe participating companies should
be exempt from the requirements of regulations proposed under the US
Bioterrorism Act.]{.underline}**

FDA guidelines state that manufacturers operating in research and
development facilities to carry out product development and testing will
be exempt from the incoming legislation. However, it is not clear if
this applies to the sending of technical samples.

FDF would be grateful for further clarification on this important issue.

[^1]: FDF represents the UK food and drink manufacturing industry. It
    purchases some £11 billion worth (about two thirds) of UK
    agricultural produce but also imports a further £7 billion worth of
    produce for processing. UK food and drink exports in 2001 were £8.55
    billion. Some two fifths, £3.4bn, of these exports went to non-EU
    countries.