December 24, 2003

Dockets Management Branch (HFA-305)

Food and Drug Administration

1061-5630 Fishers Lane

Rockville, Maryland

20852

**RE: Docket 02N-0278, RIN 0910-AC41 -- Prior Notice of Imported Food**

Dear sir or madam:

I am writing on behalf of the Canadian Trucking Alliance (CTA) in
response to the request for comments on the above-noted interim final
rule, which was published in the Federal Register on October 10, 2003.

By way of background, the CTA is a federation of Canada's regional and
provincial trucking associations formed to represent the views of the
industry on national and international policy issues. CTA member
associations include:

-   Atlantic Provinces Trucking Association

-   Quebec Trucking Association

-   Ontario Trucking Association

-   Manitoba Trucking Association

-   Saskatchewan Trucking Association

-   Alberta Motor Transport Association

-   British Columbia Trucking Association

The associations comprising the CTA federation collectively represent
some 4,000 companies across Canada. The Canadian trucking industry as a
whole generates over \$50 billion per year in freight revenue, and in
2002 carried about two-thirds (by value) of Canada's \$564 billion trade
with the United States, including most of the food shipped across the
border. Further information on the CTA, and the importance of Canada-US
trade, can be found at [www.cantruck.com](http://www.cantruck.com/).

It is clear that the interim final rule on prior notice published on
October 10, 2003, addresses a number of significant issues brought
forward by CTA and other interested parties in response to the proposed
rule published earlier this year. In particular, we note that FDA has
chosen to work with US Customs and Border Protection (CBP) to use their
Automated Commercial System (ACS) as a conduit or pipeline for
information to the FDA's OASIS system. We note that time frames for
prior notice have been brought closer to those required by CBP under
rules published pursuant to the *Trade Act*. Finally, the introduction
of a fairly lengthy period of educational enforcement should help all
parties in the trade chain to adjust business processes and practices to
meet the new requirements without fear of fines or significant
disruptions at the border. We view each of these measures as essential,
but they are only a first step.

Despite the positive developments noted above, CTA believes that
additional refinements are necessary to the interim final rule in order
to further align its requirements with those of other programs and
measures, particularly those of CBP. It is our view that changes
designed to streamline requirements and reduce the potential for
problems at the border can be accomplished without compromising the
essential goals of the *Bioterrorism Act,* to protect the US food
supply. At this point we have had just over a week to assess the impact
of the interim final rule on operations, and to be frank, with such
limited experience and less than full enforcement it is difficult to
draw too many conclusions. For this reason CTA expects to make an
additional submission when the comment period is re-opened in March,
2004. However, we do believe we have sufficient knowledge at this point
to make the following observations and suggestions.

1\. As noted above, some progress has been made in bridging the gap
between CBP and FDA. The use of ABI/ACS to supply FDA with prior notice
information is a step forward, but it must be recognized that
fundamental differences remain between FDA's prior notice rules and the
advance cargo information rules published by CBP under the *Trade Act*.
These discrepancies are bound to cause confusion.

From a practical standpoint, what this means is that trucking companies
will have to abide by two different sets of rules depending on the
commodities carried in a particular truck. If a truckload carrier is
moving electronic components to the US from Canada, CBP advance cargo
information rules will apply. If the same truckload carrier is moving
canned apple juice, FDA's prior notice rules will come into effect. If
it happens to be a less than truckload carrier with both electronic
components and apple juice in the same trailer, the carrier will have to
be able to comply with both.

CBP Commissioner Bonner, at a trade symposium in Washington in late
November, indicated that the two agencies were continuing to work
together to iron out differences between FDA prior notice requirements
and CBP's advance cargo information rules. CTA would strongly encourage
this process. We see no practical advantage from a security standpoint
in having industry comply with two sets of advance notification rules.
We would further suggest that a common set of rules will lead to better
compliance rates and fewer disruptions at the border, goals shared by
CTA and FDA alike.

2\. In a similar vein, CTA wishes to note that the two hour advance
notice period is a bit deceiving, since it doesn\'t take into account
the time a broker may require to submit prior notice information and
receive an acknowledgement back from FDA. Carriers have been telling CTA
that brokers are advising clients to build additional time into the
process, in some cases two or three hours. This may not be a problem for
all shipments, but it will cause difficulties in many instances. A
simple example is bulk flour shipments, which are timed to meet bakery
schedules in the US. Currently a truck is dispatched as soon as the
order arrives and can cross the border from Canada and reach the bakery
in a couple of hours. If a four to five hour period is now required,
this type of operation will have to be re-structured. Yet it is not
clear what security benefits will accrue by having the truck sit and
wait.

Therefore, as part of the effort to eliminate discrepancies between the
two rules, and to help address situations such as the one described
above, CTA would suggest that the shorter time periods outlined in
CBP\'s advance cargo information final rule should prevail.

3\. CTA is deeply concerned that FDA will no longer confer low-risk
status on certain pre-qualified importers, carriers and shippers, and in
return grant these companies expedited treatment at the border.

The most obvious example of this type of thinking is FDA's decision to
eliminate food products from BRASS. The irony is that at the same time,
CBP and its Canadian counterpart, the Canada Border Services Agency,
have been vigorously promoting risk management approaches for both
people and goods through the NEXUS and FAST programs respectively. It is
difficult to argue with the rationale behind these programs. They allow
expedited treatment at the border for pre-screened, low risk parties,
and free up enforcement resources to concentrate on people and goods of
unknown or higher risk. They are prime examples of how security and
efficiency can co-exist at the border. As cross border traffic grows
between Canada and the United States, programs such as FAST and NEXUS
will be absolutely vital to ensuring that border crossings do not become
choke points and stifle the economies of both nations.

Unfortunately the decision to eliminate food products from BRASS
eligibility suggests that FDA has no faith in these sorts of risk
management programs, even though other agencies of the US government,
with an equal stake in border protection and national security, are
vigorously marketing them. While it is acknowledged that food has never
been eligible for expedited treatment under FAST, CTA is aware that the
Canadian government is currently looking at ways to increase the range
of qualifying products. CTA would strongly encourage FDA to work with
CBP and relevant Canadian agencies to examine how a program such as FAST
could include food. Particular attention will have to be paid to
ensuring buy-in from importers, so as not to make eligibility so onerous
as to drive them from the program. We are confident that a close
examination of FAST, which is predicated on security throughout the
supply chain, could be implemented without compromising the safety of
the US food supply.

4\. It is not clear to CTA to what extent FDA and CBP have worked with
the Canada Border Services Agency and the bridge authorities to address
issues surrounding refusal of entry due to missing or incomplete prior
notice information. CTA is aware that local staff at busy border
crossings such as the Peace Bridge and Ambassador Bridge have indicated
that trucks will be turned back for missing/incomplete prior notice if
secure storage cannot be arranged. Given the scope of operations and
limited space available at these locations, this is understandable from
a logistical standpoint.

Canadian government officials have told CTA that they are examining this
issue. One proposal would be to have CBP stamp a shipping document (such
as the bill of lading) "Refused -- BTA". It is also understood that CBP
has procedures in place for refused trucks which pre-date the BTA.
Regardless of what method is adopted, the essential point is that the
relevant agencies on both sides of the border should have a plan in
place to deal with the inevitable problems posed by larger volumes of
returning trucks so that busy border crossings do not become a no man's
land.

5\. Many concerns have been expressed regarding the fact that prior
notice confirmation numbers will be sent to the filer (usually a
broker), but a mechanism doesn\'t exist to get this number to the
carrier. It is CTA's understanding that since implementation on December
12^th^, many carriers have been demanding that a shipper present the PN
confirmation number(s) to them before a shipment will be picked up. At
the same time one has to be realistic and expect that PN numbers may be
missing for a certain percentage of shipments due to incomplete or
inaccurate information, and that carriers will not want to turn down
business if it appears that only one or two PN's are missing from a
truck that may require dozens or even hundreds. In addition, time
constraints in certain industries (e.g., fresh seafood) will demand that
a truck be dispatched to the border *before the PN confirmation number
has been issued*.

In both instances described above, the truck will be traveling "blind"
to the border on the expectation that a prior notice confirmation number
will be issued before the crossing is reached. However, the truck
driver, under the current rule, is two steps removed from receiving the
notice, as it will go first to the filer (likely a broker), and from
there to the broker's client (the Canadian shipper or US importer).
Various solutions have been discussed for addressing this problem,
including e-mail messages to the carrier identified in the prior notice
information. CTA would encourage FDA and CBP to work out a protocol on
how this could be accomplished.

6\. Discussions between CTA, brokers and officials from CBP and FDA
suggest there is likely to be a problem with so-called \"dual mode
filers\", or brokers who must present paper copies of required documents
to FDA before a truck is allowed to leave the customs compound. Though
it is not clear at this stage the extent to which this problem exits, it
is apparent that at certain busy border crossings such as Buffalo,
N.Y./Fort Erie, Ontario, some brokers are required to submit paper
copies of required documents to FDA after the release has been obtained
from CBP.

In practical terms this means is that even if a load is cleared using
the Pre-Arrival Processing System (PAPS), and a prior notice
confirmation number has been issued by OASIS, the driver will still have
to "walk the paperwork" to FDA before leaving the border crossing. An
additional complication stems from the fact that a customs officer in
the primary inspection booth will not be given any indication of the
broker's status. Therefore, it is entirely possible that a driver will
be given a \"may proceed\" message by CBP, when in fact he should be
reporting to FDA so that paperwork can be verified.

This situation will no doubt lead to compliance problems and may expose
carriers and drivers to unwarranted penalties. As well, considering that
many food shipments were cleared with BRASS prior to December 12^th^,
2003, a significant number of drivers and carriers are now having to
adapt to a completely new way of dealing with border crossings. The
desired outcome is to have as many trucks as possible clear at the
primary line so that secondary parking areas do not become backlogged
with trucks reporting to FDA.

It is suggested that during the current period of educational
enforcement, FDA and CBP examine the impact of dual-mode filers on BTA
compliance, and make whatever adjustments are necessary to border
processing procedures to ensure carriers are given clear direction at
primary inspection. This should reduce the possibility that a truck will
leave the port of entry without proper FDA release. Fines, penalties and
delays should likewise be reduced. As well, CTA suggests that the OASIS
status of brokers be made available to carriers upon request from FDA at
each US port of entry, so that carriers can plan ahead and educate their
customers, drivers and operational staff on this issue.

7\. The sheer volume of prior notice confirmation numbers is bound to
cause problems as we move forward into implementation. As noted above,
because PN's are attached to individual "articles of food", it is
entirely possible that dozens or hundreds will be required for a single
truck, particularly in the less-than-truckload environment. A carrier
could achieve compliance of 99+ percent -- for example, 199 out of 200
PN's properly submitted for a given truck -- but the truck could still
end up re-routed to secure storage in the US, or turned back to Canada,
if the 200^th^ is missing or incomplete.

A possible solution to this problem would be to relate the prior notice
to all food products on a single bill of lading rather than assigning
one to each and every article of food. Under this scenario FDA would
still receive prior notice on all food products, but would, in effect,
"clear" the entire shipment from a single shipper to a single consignee,
carried on the same truck. No doubt this solution would have to be
examined carefully -- for example, what mechanism would there be for
advising the shipper and carrier that a single product in a shipment
raised concerns for FDA? Nevertheless, CTA believes it would be worth
exploring in greater detail.

8\. In closing, CTA would like to place the FDA prior notice rule within
the broader context of security, trade and the border. The prior notice
interim final rule is just one of the myriad of new programs, rules and
requirements that the trade community is currently adapting to in order
to meet the US security agenda. CTA does not question the importance of
this agenda, and the carriers we represent, drawn from both sides of the
border, have so far been willing to do their utmost to adapt to the new
reality. Yet we note that at the same time carriers have been gearing up
for prior notice implementation they have also been:

-   Registering, as required, under FDA's food facility registration
    rule

-   Developing strategies to comply with advance cargo information rules
    published on December 5, 2003, by CBP

-   Signing up, in the hundreds, for C-TPAT and FAST

-   Registering drivers, in the thousands, for FAST

-   Complying with vastly increased VACIS scans at the border

-   Preparing for implementation of *Patriot Act* requirements for
    security screening of drivers moving hazardous materials

-   Complying with new Department of Transportation security
    requirements for the transportation of explosives

-   Responding to requirements for enhanced security imposed by
    individual seaports in both the US and Canada

-   Ensuring landed immigrant truck drivers have the appropriate visas
    to ensure continued access to the United States

-   Monitoring the potential impact on the truck driver population of
    the Transportation Worker Identity Credential, or TWIC, which is
    currently being developed by the Transportation Security
    Administration; and the US Visit program, which Homeland Security
    plans to implement on the land border in a little over a year

-   Preparing for the CBP's Automated Commercial Environment and
    Canada's Advance Commercial Information, both of which will contain
    an advance cargo reporting component

Each and every initiative identified above is intended to enhance the
security of the United States. Yet at some point one has to stand back
and look at the "big picture." Have we reached the point of diminishing
marginal returns? Can trade continue to function in a more or less
efficient manner if we continue to layer new and sometimes conflicting
or incompatible security programs on top of those already in existence?
And finally, is the situation at the border becoming so complicated that
carriers and drivers are no longer confident that they even know *how to
comply*? CTA accepts that these are not questions for FDA alone, and
would only request that in considering changes to the interim final
rule, that these "big picture" issues be taken into consideration.

CTA appreciates the opportunity to comment on this interim final rule.
As previously noted we would expect to file further comments next March
once the industry has had more experience working with FDA prior notice
requirements.

Sincerely,

![](media/image1.png){width="2.33125in" height="0.8326388888888889in"}

Ronald Lennox

Vice President, Regulatory Affairs