By e-mail

Division of Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, room 1061

Rockville, MD 20852

23 December 2003

*Re: Comments on the Interim Final Rule; Prior Notice of Imported Food
Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Docket No. 02N-0278)*

Dear Sir or Madam

**[IMPLICATIONS FOR THE FINE WINE TRADE]{.underline}**

**1 Introduction**

1.1 The Wine & Spirit Association

The Wine and Spirit Association of the UK represents fine wine traders,
importers, shippers, wholesalers, and retailers of wine and imported
spirits sold on the UK market. Its principle functions are to deliver
services to members and to represent their interests to government in
the United Kingdom and in the European Union.

Further details about the Association can be obtained from
www.wsa.org.uk.

1.2 The Fine Wine Trade

London is renowned throughout the world as the centre for the trading of
[^1]fine wines on the [^2]secondary market: sales in this sector are
estimated at £120,000,000 per year (excluding value added tax) and are
generated by Merchants, Traders and Auction Houses mainly in the UK. In
addition, fine wine sales to the US are also traded direct from France,
Germany, and Switzerland.

Exports from UK to the US - the biggest single market for fine wines -
are conservatively estimated at £30,000,000 per year.

Success in the fine wine trade depends on meeting consumers' demands
quickly and efficiently, and it relies on a relatively liberal trading
environment which hitherto has been enjoyed both in the UK and in the
US. Sales from the UK to the US are invariably of high value and in
small packages, frequently by mail order: these account for 5,000
different wines (brands) mainly from France, Italy and Germany; 600,000
bottles per year; 50,000 cases (x 12 bottles). The trade is
price-driven, and if the US market for these unique products were to be
damaged, there would undoubtedly be a negative knock-on effect on prices
worldwide.

Having attempted to implement the prior notice element of the US
Bio-terrorism Act, it is a strongly held belief by fine wine traders in
the UK and in the US that the proposed new FDA registration measures
will be unworkable and incompatible with the nature of this important
niche market.

UK, French, German and Swiss shippers and their US importers will be
severely disadvantaged if they have to adhere to the proposed clerical
requirements of the US Bio-terrorism Act. The bureaucracy involved for
compliance will be unsustainable, and will probably be out of all
proportion to the risks involved, given the controls on the movement of
excise goods which are already in place. Imports into the US of these
wines will virtually cease overnight on the strict interpretation of the
new rules. In addition, the US consumer will be denied the ability to
buy the fine wines that he has always been able to enjoy.

**2 Concerns of the Fine Wine Trade**

2.1 Registration

Producer registration numbers are not readily accessible to fine wine
traders and brokers operating in the secondary market: such traders
often buy wines many years after they have left the producer's premises
and, having no *prima facie* relationship with the producer, have no way
of acquiring the producer's registration number, not least because the
producer may no longer exist.

2.2 Prior Notice: bureaucracy involved

Following pre-implementation trials in the UK, an example of the
bureaucracy involved by exporters to the US is as follows:

A normal 20ft refrigerated container consignment to the US would consist
of around 500 cases of fine wines. These 500 cases consist of 200
different brands and possibly various different bottle sizes / packing
formats i.e. 6 x 75cl cases, 12 x 75cl cases, 12 x 37.5cl, 24 x 37.5cl,
3 x 150cl, 6 x150cl etc etc. Prior Notice would need to be lodged for
each brand, and then each bottle size and format. Therefore, an exporter
to the US could possibly lodge over 1500 Prior Notices for just one
small container.

**3 Proposed Solutions**

The Wine and Spirit Association fully supports the comments submitted to
the Food and Drug Administration on behalf of the California Fine Wine
Alliance (\"Fine Wine Alliance\").  As set out in the Fine Wine
Alliance\'s comments, the requirement for the food facility registration
number is beyond the expressed intent of the U.S. Congress.  The most
appropriate solution to cut bureaucracy is to remove the requirement for
the food facility registration number as part of the prior notice
requirement.  We also agree with the Fine Wine Alliance that if this
solution is not possible then the alternative solution proposed by the
Fine Wine Alliance should be implemented. 

These issues are discussed in further detail, as follows:

3.1 The intention of Congress: "Gold Plating" by the FDA

*FDA's requirement for a food facility registration number has gone
beyond the intention of Congress*.

We understand that Congress did not intend the requirement of such
information and has provided the FDA with adequate enforcement tools to
ensure that 'facilities' are in compliance.  Furthermore, the FDA
appears to have disregarded the intent of Congress by including into the
prior notice provision the requirement for the registration number. 
Therefore, modification to the prior notice regulation to remove the
requirement for a registration number would be a more faithful
interpretation of the statute and Congress's intent.\
\
3.2 Amendment of Prior Notice Requirement

*If it is not possible to remove the requirement for a food facility
registration number, provision should be made for the
[notifier]{.underline} to give a reason for the absence of a number.*

If the FDA believes that removalof the registration number cannot be
accommodated, another mechanism to mitigate the disproportionately
negative effect on wine importers and distributors would be to amend the
prior notice requirement so as to allow the [notifier]{.underline} to
provide the FDA with a reason for the absence of a registration number. 
The presumption would be that a registration number should be provided;
however, if such a number is [unavailable]{.underline}, as is the case
with many wine importers and distributors operating in the secondary
market, an opportunity to provide a reason should be permitted. 
Specifically, a drop down menu should be provided next to the space
entry for registration numbers that allows the importer to explain the
reason for the lack of a registration number.  The drop down menu may
list a standard explanation such as "product was not obtained from
manufacturer."  After evaluating the prior notice, the FDA may choose to
inspect the product based on the absence of the registration number. \
\
This optional approach allows the FDA to continue to require
registration numbers, but does not *per* *se* invalidate a prior notice
based on the absence of this single piece of information.  If necessary,
the FDA may require that the [notifier]{.underline} submits a statement
of "good faith belief" that the winery is properly registered with the
FDA.   By instituting this option, the need for the FDA review under 21
C.F.R. § 1.285 is bypassed, and opens up the Agency's limited resources
and minimizes the delay of imported product. 

Yours faithfully

John Corbet-Milward

Head of Technical and International Affairs

Wine & Spirit Association

19 December 2003

[^1]: Fine Wine: is loosely defined as any wine that is produced to age
    and improve in the bottle.

[^2]: Secondary market: is the open market that exists for any wine once
    it is sold on in bottle by its original buyer who could be a
    merchant or a private individual. Wines traded in this way can
    change hands several times before they reach the final consumer. (A
    similar model is that of the Fine Art trade)