2003D-0554 Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
FDA Comment Number : EC9
Submitter : Ms. Carol McGlennon Date & Time: 04/13/2005 06:04:32
Organization : Tracon Consultants Ltd.
Category : Food Industry
Issue Areas/Comments
GENERAL
GENERAL
This refers to the revisions in the Compliance Policy Guide (Federal Register Notice March 4, 2005, Vol. 70, No. 42) with respect to shipments through the United States from and to the same country. The FDA's revised Compliance Policy Guide falls short of resolving our problem which involves in-transit shipments from Canada to Canada through the U.S. The FDA criteria that must be met in order to take advantage of the new exemption are too restrictive with respect to frequency of shipments and distance travelled through the U.S. Also, the requirement of practicality leads to uncertainty. I will elaborate below.

When all other criteria are met, those regarding frequency of shipments and distance travelled through the U.S. have no bearing on the risks associated with imports of food products which seem to be the FDA's primary concern. Meeting all of the other criteria, in combination with Customs requirements, is sufficient for monitoring and risk assessment. A regular shipper, using the same ports of entry and exit, with sealed containers, etc., can adequately demonstrate reliability. Frequency of shipments and distance travelled are not factors necessary to determine reliability.

Due to the geography, a significant amount of money would be saved for us by using a route through the U.S. making this the only practical alternative for us. Does this satisfy the requirement for practicality? Any other alternative for us is burdensome and impractical.

We request an amendment to the new FDA compliance policy that would allow for shipments of greater frequency and greater distance as the current criteria are unnecessary to meet the FDA's objectives and due to the burden the prior notice requirements impose on Canadian vendors and shipping resources.

Our previous submission on this issue is attached.
2003D-0554-EC9-Attach-2.DOC