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 : EC470
Submitter : Mr. Patrick Donoho Date & Time: 05/17/2004 06:05:02
Organization : International Bottled Water AAssociation
Category : Food Association
Issue Areas/Comments
Docket No. 02N-0278 ? Prior Notice for Food Importation
IBWA again commends FDA for the work with Customs and Border Protection in developing a single submission system for the information satisfying the prior notice requirements. By eliminating duplication of submissions and the integration of the systems, substantial hindrances to trade may be avoided. IBWA strongly urges FDA continue working with the CBP to harmonize the two agencies requirements for submission of imported food information as much as possible. IBWA recommends that the timelines for prior notice be better harmonized with CBP as FDA finalizes the prior notice regulations. This will be particularly helpful in managing the prior notice with food imports from Canada, which is generally by truck or rail. Utilizing one system and one set of timelines should provide adequate notice to FDA and improve compliance with the prior notice requirements.
In the past, bottlers have experienced variations in interpretation of the appropriate product code on imported bottled waters and analytical samples. This is a result of complexity of the FDA product code builder and its application to bottled water. The issue is now compounded because there are no product codes in the FDA Product Code builder or under CBP for water samples used in analytical testing. The result has been confusion and delays in the importation of bottled water. CBP agents have begun to refuse entry for lack of prior notice for analytical samples after reviewing the shipping documents that show the container contents as analytical water samples, even when they are not intended for human consumption and not in consumer packaging. IBWA urges FDA to provide guidance to CBP and the bottled water industry on how to proceed with importing water samples for analytical testing. In IBWA?s prior comments on the interim final regulation and a December 3, 2003, letter to FDA, to which FDA has yet to respond, IBWA outlined the rationale to classify such samples as ?dual use? and not intended for human consumption.
Sampled water must be analyzed within certain strict time frames of collection. Delays can render the samples useless, requiring additional sampling and causing production delays until reliable sample results could be obtained. To ensure analysis occurs within specified time frames, these samples are routinely sent to the analyzing laboratory using international express courier services such as Federal Express or DHL. Such shipping methods also enable the laboratories to maintain a reliable chain of custody for the sample.
In addition, foreign bottled water facilities may not be registered with FDA as a food facility because the decision to export to the United States is pending the outcome of the test results. According to the interim final rule on prior notice, it is not possible to properly fill out the prior notice without a facility registration number. To require a foreign company to secure a U.S. agent and complete the food facility registration process before a decision to do business in the United States is made places an undue burden on international trade. The necessary information to establish the sender and the recipient of the water samples is contained in the paperwork of the courier service.
As IBWA has explained in the earlier communications, water samples for analytical testing are clearly not intended for human or animal consumption. For ?dual use? products, such as water samples for analytical testing, a code needs to be developed so that the products can be readily identified and move smoothly through entry into the United States. This product code(s) will clarify the contents as not intended for human consumption and eliminate any confusion at the border on the need for prior notice.
Please include the attached file as the complete comment by IBWA.