2002N-0278 - Prior Notice of Imported Food Under the Publich Health Security and Bioterrorism Preparedness and Response Act of 2002; Notice of Availability of Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes
FDA Comment Number : EC457
Submitter : Mr. Dean Byers Date & Time: 05/17/2004 06:05:08
Organization : Pepsi QTG Canada Inc
Category : Food Industry
Issue Areas/Comments
General comments on Prior Notice Submission Questions:

1. Should food products subject to FDA?s prior notice requirements be eligible for the full expedited processing and information transmission benefits allowed with C-TPAT and FAST? If so, how should this be accomplished?

Yes, the CBP at primary should be empowered to be the liaison for all releases and provide the driver with a formal acknowledgement of the shipment?s FDA status (i.e. stamp the driver?s paperwork or provide a document.) This would eliminate the need for the driver to report to secondary for confirmation of FDA status and alleviate congested parking lots.

2. If the timeframe for submitting prior notice for food arriving by land via road is reduced to 1 hour consistent with the timeframe in the advance electronic rule, would a shorter timeframe be needed for members of FAST?


3. Should the security and verification processes in C-TPAT be modified in any way to handle food and animal feed shipments regulated by FDA? If so, how?

Yes, C-TPAT requirements should encompass any industry and if there are specific food security measures required, then they should be incorporated into C-TPAT?s checklist.

4. If timeframes are reduced in FDA?s prior notice rule, would other flexible alternatives for participants in FAST or for food imported by other agencies be needed?

When participating in the FAST program all releases should be communicated at primary and this would eliminate the need to report to secondary for FDA status.

5. In considering flexible alternatives for food imported by other government agencies, what factors or criteria should FDA consider when examining alternatives? Should participation be voluntary? If so, should FDA consider inspection of companies in the supply chain from the manufacturer to those who may hold the product, including reviews of their security plants to determine what procedures are in place to prevent infiltration of their facilities as a condition of participation?

If a company is a C-TPAT participant they?ve already gone through an extensive review of their security programs and reached out to their supply chain partners as well.

FDA should consider inspecting those companies which aren?t C-TPAT approved to ensure their processes are compliant.

6. In considering flexible alternatives for submission of prior notice, should FDA consider additional means of ensuring that all companies subject to the registration of food facilities interim final rule have an updated registration on file with FDA that has been verified?

7. Are there conditions of participation that FDA should consider, e.g. inspection of companies in the supply chain from the manufacturer to those who may hold the product, review of their security plans to determine what procedures are in place to prevent infiltration of their facilities?

Yes with C-TPAT approval a company has already reviewed their security measures whereas there should be FDA criteria for non C-TPAT participants to comply with.

8. Should the food product category be considered as a criteria or element of expedited prior notice processing or other flexible alternatives? If so, should certain foods be excluded from expedited prior notice processing? If so, what should be the basis for determining which foods should be excluded?

9. If FDA adopts reduced timeframes in the prior notice final rule, should FDA phase in the shorter timeframes as CBP phases in the advance electronic information rule?

FDA & CBP should work in parallel regarding timeframes.

10. Should FDA office a prior notice submission training program for submitters and transmitters, including brokers, to ensure the accuracy of the data being submitted?