0520-commentEC1

Submission by Tracon Consultants Ltd. to
Food and Drug Administration
Agency Information Collection Activities
Proposed Collection
Comment Request
Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
Docket No. 2006N-0202
FR Doc.: E6-8311 May 31, 2006 (Volume 71, Number 104)
This submission is to address the Food and Drug Administration’s invitation for
comments on whether the proposed collection of information is necessary for the proper
performance of FDA’s functions, including whether the information will have practical
utility.

We refer the FDA to our previous two submissions that can be found at the following
internet link: http://www.fda.gov/OHRMS/DOCKETS/dockets/03d0554/mostrecent.htm
under document number EC9. Our concern is regarding goods transshipped securely
through the United States from one point in Canada to another point in Canada. When we
say securely we refer to goods shipped by a Customs-Trade Partnership Against
Terrorism (C-TPAT) or Partners In Protection (PIP) certified exporter, and a C-TPAT
certified carrier, with a C-TPAT approved bolt seal on the container. PIP is the Canadian
equivalent to the C-TPAT program. It is our submission that in this situation prior notice
is not necessary for FDA to perform its functions for the following reasons:
•

the goods do not enter the commerce of the United States nor disembark in the
United States nor remain in the United States;

•

the parties responsible for the goods (exporter and carrier) are classified as lowrisk having undergone the rigorous and thorough approval and compliance
processes of U.S. Customs and Border Protection (CBP) and Canada Border
Services Agency (CBSA).

Tracon Consultants Ltd. Submission Re: FDA Docket No. 2006N-0202

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The FDA is responsible for determining whether shipments arriving are of risk in order to
protect the nation’s food supply against terrorist attacks and other public health
emergencies. Shipments entering the United States under the circumstances described
above have already been determined to be low risk and therefore the requirement that
they be subject to the Prior Notice requirements is redundant. This means Prior Notice is
not required in this situation for FDA to properly perform its functions and the
information that would be provided to FDA will have no practical utility.

We would like to comment as well on the burden of the Prior Notice requirement not in
reference to the context in which it is presented in the Federal Register Notice but rather
in the context of our own experience. The current requirements eliminate the option of
transshipment through the United States as described in our previous submissions due to
the nature of the shipments and the inability to meet the Prior Notice time and data
requirements. The burden, therefore, in our particular case, is an increased annual
transportation cost of $60,000 that results from east (Ontario) to west (British Columbia)
routing through Canada. Burden in hours is incalculable as Prior Notice is not an option.

We again request, therefore, that such shipments be exempt from Prior Notice
requirements as they are redundant, these shipments are low risk and the requirements are
not necessary for FDA to fulfill it’s functions.

Submitted by:
Carol A. McGlennon
Tracon Consultants Ltd.
1912-130 Albert Street
Ottawa, Ontario
Canada K1P 5G4
carolm@tracon.ca
tel: 613-238-1586

Tracon Consultants Ltd. Submission Re: FDA Docket No. 2006N-0202

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