2002N-0278 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Extension of Comment Period
FDA Comment Number : EC505
Submitter : Mr. Lee Frankel Date & Time: 07/28/2004 06:07:05
Organization : Fresh Produce Association of the Americas
Food Association
Category :
Issue Areas/Comments
Re: Docket 2002N-0278

The FPAA appreciates the opportunity to comment on the Prior Notice of Imported Food Rule. The FPAA represents approximately 125 U.S. importers of fresh produce grown in Mexico.

Question 1.
The FPAA believes that food products subject to FDA's prior notice rule by land via road should be eligible for the full benifits allowed under the C-TPAT and FAST programs. Limitations of benefits would be a failure of the FDA to understand the counter terrorism programs and would work contrary to the intent of the Bioterrorism Act. The purpose of the Act is to minimize the risk of damage to U.S. health and the economy from intentional terrorist acts. The nature of the FAST and C-TPAT programs are to evaluate and understand the risk profiles of the participants in advance so that federal enforcement resources can be most effectively deployed. Furthermore, the C-TPAT and FAST programs are specifically focussed on terrorism acitivities. The terror threat and mitigation process is already built into the FAST process; therefore, all FDA concerns regarding potential terrorist acts should have already been built in the C-TPAT and FAST certification process. For effective enforcement while minimizing damage to the U.S. and other economies, FDA should follow the timeframes established by DHS and organize its staff and the prior notice review center in a manner that can address very low risk shipments in less than half an hour.

Question 2.
As stated in the response to question 1, FDA should not create arbitrary time frame differences for prior notice timeframes, especially for FAST participants. If there is truly a partnership between industry and the government in the fight agains terrorism, the FDA must be able to have the management capacity to review very low risk shipments in the 30 minute time frame offered by the DHS.

Question 3.
Consideration should be given in the security review process for food and animal feed shipments. If certain food products that are grown in open fields are brought to centralized packing and processing facilities, items such as field security and background checks of migrant farms workers that carry few documents may not be the most effective use of resources; whereas tighter control of packing facilities might be the best place for heightened emphasis and scrutiny. In addition, consideration should be given to determine the proper starting point in the supply chain to insist on the C-TPAT certification; for instance, should it start at the plant breeder, the seed farm, the irrigation supply company the field, the packing house, or the final staging and inspection area prior to entry into the United States.

Flex Question 1
The FDA should focus on working in conjuction with DHS to ensure that timeframes are as close as possible for prior notice and that intellegence
infromation regarding rsik is shared in both directions to maximize the security of the United States.

Flex Question 2
FDA must fully participate and cooperate with DHS in the development of the appropriate criteria for the counter terrorism programs being developed in conjuction with the industry. Participation should be on the same basis as that of U.S. producers of food. If there is no mandatory program for U.S. producers, foreign producers should not have to meet a significantly higher barrier to entry to market.

Flex question 3
FDA should verify the accuracy of facility registration information for both U.S. and foreign entities. While infrastructure is in place with imported product, the FDA should consider manning checkpoints at state lines within the U.S. to ensure compliance by U.S. firms.

Flex 5
Food product category should not be the basis for exclusion or inclusion into expedited entry programs, rather, the profile of each firm in the supply chain as determined by the DHS audit should determine eligibility.


Lee Frankel