March 26, 2003

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, Maryland

USA 20852

**Re: Dockets No. 02N-0278 and 02N-0276, Proposed Rulemaking, Prior
Notice of Imported Food and Proposed Registration of Food Facilities
Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002**

This letter is respectfully submitted by the Canadian National Millers
Association to provide comment on proposed provisions governing
importation of foods, food products and food ingredients into the United
States as published in the Federal Register on January 29, 2003.

**Canadian National Millers Association** (CNMA)

The Canadian National Millers Association is an independent, Canadian,
federally chartered not-for-profit, national industry association. The
CNMA has 17 member companies representing Canadian owned and controlled
grain milling companies as well as U.S. and Japan based multinational
food processing companies who operate wheat, oat and corn milling
facilities within Canada. A list of CNMA member firms and facility
locations is appended.

CNMA members represent approximately 90 per cent of all grain milling
capacity operating in Canada. The majority of processing facilities
operated by CNMA members are situated within 150 miles of the
Canada-U.S. border and export a portion of total output of wheat flour,
wheat bran and milled oat and corn products used as food ingredients by
U.S. based further processors.

CNMA member milling facilities are located in 7 Canadian provinces
across Canada. These are:

British Columbia

Alberta

Saskatchewan

Manitoba

Ontario

Quebec

Nova Scotia

As a consequence, Canadian exports of milled grain products enter the
U.S. at many inland ports of entry.

**Transportation of Canadian Milled Grain Products to U.S. Customers**

We estimate that over half of the approximately 200,000 tonnes of
Canadian milled grain product exports to the U.S. are transported by
truck in pneumatically unloaded bulk tank trucks. These bulk trailers
are typically gravity/pneumatic loaded at milling facilities and sealed
by the exporter prior to departure from the loading bay. In order to be
accepted by the importer, the seals must be intact at point of delivery.

A significant portion of these exports are also shipped in packaged
form, typically in 20 kg. and 40 kg. (45 and 90 lb.) double-walled and
triple-walled bags, usually palletized and shrink wrapped. These
products normally are shipped by truck but can also be shipped by
container and inter-modal trailers. A portion of milled grain products
also moves into the United States in bulk by bulk rail cars, also sealed
at time of loading at milling facilities.

Wheat flour and bulk products of oat and corn milling are shipped to
U.S. customers 52 weeks per year, 7 days per week. These products are
food ingredients used, like auto parts, on a just-in-time delivery
schedule. We estimate that there may be as many as the following
shipments annually

5000 export shipments by truck, bulk and bagged product

1200 by rail bulk carrier

1000 by rail/truck intermodal for bagged product

**CNMA Recommendations to Meet U.S. Import Requirements Under Proposed
Measures**

**1.** **Registration of All Manufacturing and Exporting Facilities**

CNMA is in full agreement that all Canadian grain milling companies
wishing to export to the United States should be registered with USFDA
as proposed. Our only concern lies with the narrow (60 day) window
proposed for registration and acknowledgement of the registration of all
facilities for all exporters to the U.S. We trust that USFDA will have
the necessary resources in place to ensure that the usual flow of milled
grain products to U.S. customers is not interrupted as a consequence of
overloading of the registration system during its early months of
operation.

**2.** **Prior Notice Window**

Having considered the range of distances of Canadian milling facilities
from U.S. inland ports of entry, the variety of shipment types (bulk,
bag, truck, rail, intermodal) and the recent experience of CNMAs member
firms, it is our understanding that transit from point of loading to
arrival at a U.S. port of entry can well exceed 5 days in the case of
rail movement. The CNMA believes the maximum prior notice period should
ultimately be greater than 5 days but at a minimum, the 5 days
prescribed in the 2002 legislation.

CNMA also recommends a minimum prior notice window of not more than 4
hours, as was contemplated during early months of Canada/U.S. bilateral
consultations on this matter in the first half of 2002.

We would further recommend that upon satisfactory implementation of the
new measures between late 2003 and early 2005, USFDA consider reducing
the minimum notification period to as little as one hour for major ports
of entry and for products such as milled grain products that do not
normally require USFDA inspection at port of entry.

**3. Amendment of Prior Notices**

It is not clear from proposed provisions published in the Federal
Register in January how the new system will accommodate variations in
shipment weights for products such as milled grain products. The actual
loaded net weights of milled grain product shipments can vary
significantly. These variations are due primarily to product moisture
content and variations in actual capacity of bulk trailers and rail
cars. The actual load weight is not known until time of vessel (bulk
trailer or rail car) loading.

Accordingly, CNMA recommends one or more of the following:

-   a plus or minus shipping weight tolerance for bulk shipments of
    milled grain products that reflects normal variations in load
    weights

-   a system that permits notification by the exporter of actual loaded
    (net) weight of the shipment not less than one hour prior to
    presentation of shipment at declared port of entry

**4. Declared Port of Entry**

There are some regions along the Canada/U.S. border where carriers would
have more than one option for a shipping route and therefore for a
declared port of entry. One example would be Sarnia, Ontario and
Windsor, Ontario. Considering the many variables in transport time and
road conditions that could be faced by carriers in most regions along
the Canada/U.S. border (weather, road conditions, road, construction,
equipment breakdowns, delayed loading at point of manufacture) there may
be significant advantages to exporter and importer of having some
flexibility of declared port of entry.

Having noted the intent of the proposed provisions to specify a single
USFDA office responsible, CNMA would recommend that exporters/importers
be able to declare up to three possible ports of entry on the
understanding that these would all fall under the jurisdiction of a
single USFDA regional office for administrative and inspection purposes.

**5. Identification of Grower**

CNMA assumes the proposed requirement to provide identification of
grower, if known, was intended predominantly for importation of
produce. However, if this provision was intended to also apply to
products of primary products such as grain milling, CNMA respectfully
asks that this intent be reconsidered in light of the logistics of
Canadian grain handling and transportation between growers and grain
millers.

In excess of 95 per cent of grain milled by Canadian milling companies
is not delivered by growers to the milling facility. Rather, grain
producers typically deliver grain to inland country elevators and
inland terminal elevators which in turn, clean, blend and assemble
rail car lots of wheat, oats and corn for shipment to Canadian
processors and export terminal destinations.

In addition, the milling process normally relies upon continuous
blending of various grades and protein levels of grain to achieve the
ingredient performance characteristics sought by individual customers.
As a consequence of grain blending during shipment to facilities and in
processing, it is virtually impossible to attribute origin of processed
grain products to individual growers.

CNMA therefore respectfully recommends that identification of growers
not be required for imported milled cereal grain products.

**6. Early and Late Arrival At Port of Entry**

Based on CNMAs review of proposed provisions as published in the
Federal Register and of information provided by Government of Canada
agencies, we understand that export shipments will be accepted for entry
into the U.S. only if they arrive at the declared port of entry not more
than one hour before or three hours after the anticipated time of
arrival as specified in the prior notification.

If this understanding is correct, we respectfully submit that this 4
hour window does not reflect the variation in transit time that will
normally occur in the climatic zones and various urban and rural areas
along the vast distance of the Canada/U.S. border. Nor does this window
reflect the variations from anticipated loading schedules that could
occur due to unforeseen delays at point of manufacture and in arrival at
point of manufacture of the vessel (bulk trailer, truck or rail car).

CNMA respectfully requests that USFDA consider expanding this arrival at
port of entry window to a period of up to 6 hours before and 18 hours
after the time declared in the prior notice.

**7. Parties Permitted to Notify**

CNMA respectfully advises that the proposed requirements to permit only
U.S. based importers or U.S. based agents of importers to provide prior
notice and amend prior notice does not reflect the best interests of
exporters, importers and USFDA or U.S. Customs Service. It is the view
of the CNMA, based on the logistics of manufacture and shipping of
milled grain products, that the exporter (milling company) is always in
the best position to provide information to USFDA on the characteristics
(load content and weight) and timing of export shipments.

Accordingly, CNMA recommends that USFDA permit the exporter to notify,
on the understanding that the U.S. based importer or the U.S. based
agent is simultaneously notified and assumes responsibility for the
shipment and for dealing with USFDA and customs services as appropriate
at port of entry. We believe this option will serve all party interests
without in any way compromising the objectives of the proposed
provisions.

**8. Cancellation of Prior Notice**

CNMA would also recommend creation or clarification of procedures for
cancellation of prior notice by the exporter at any time for any reason.
This would reflect the wide range of circumstances under which
anticipated importations do not occur as and when anticipated by the
importer.

We wish to thank USFDA for the opportunity to provide comment on
proposed measures. Should USFDA require clarification or further
information, please contact the undersigned at the CNMA offices in
Ottawa, Canada.

Yours sincerely,

Gordon Harrison

President

cc\. CNMA Board of Directors