Docket Management
Docket: 02N-0278 - Bioterrorism Preparedness; Prior Notice of Imported Food Shipments, Section 307
Comment Number: EC -32

Accepted - Volume 2

Comment Record
Commentor Mr. Enrique Lobo Date/Time 2002-08-30 17:58:35
Organization Embassy of Mexico
Category International

Comments for FDA General
1. General Comments Washington, D.C. August 29, 2002 Docket No. 02N-0278 Joseph Levitt Director, Center For Food Safety and Applied Nutrition Dockets Management Branch (HFA-305) U.S. Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: Comments of the Secretaria de Agricultura, Ganaderia, Desarrollo Rural, Pesca Y Alimentacion On the Promulgation of Regulations to Implement Provisions of the Bioterrorism Act of 2002 - - Prior Notice of Imported Food Shipments (Section 307) - - Docket No. 02N-0278 Dear Mr. Levitt: On behalf of the Secretaria de Agricultura, Ganaderia, Desarrollo Rural, Pesca Y Alimentacion (“SAGARPA”) of the Government of Mexico, we would like to submit comments identifying the principal concerns of SAGARPA over the implementation of the Prior Notice provision (Section 307) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act of 2002”). Section 307 requires that the FDA receive prior notice of food products to be imported into the United States, and that such prior notice must be received in time to permit the FDA to receive, review and appropriately respond to the notification. However, this provision also states that the prior notification period may not exceed five days. Shipments of food products sent to the United States for which no prior notification has been sent to the FDA will be refused admission into the United States. Congress did, however, direct that the FDA, in promulgating implementing regulations for this provision, to take into the account the affect on commerce of any time period by which prior notice must be received, the type of food product involved, the manner in which it is being transported, and other relevant considerations. SAGARPA believes that the regulations ultimately promulgated by the FDA to implement this provision must take into account the conditions of Mexican exports of food products to the United States. Unlike almost all other countries (with the exception of Canada), the overwhelming majority of products Mexico exports to the United States arrive at U.S. ports of entries by truck or train, not by ship or airplane. The majority of Mexican facilities exporting food products to the United States are within eight hours of the U.S. border - - and many are within a few miles of the border. These circumstances must be taken into consideration by the FDA when promulgating implementing regulations for this prior notification provision. Prior notification time periods and rules that may be applicable to shipments by vessel or plane simply will not address the need of the majority of Mexican exports to the United States. SAGARPA’s concerns are illustrated by the “default” notification provision contained in the statute (section 307(c)(2)). Requirements that prior notification be sent no less than 8 hours prior to shipment would cause significant delays in the shipment of much of the product exported from Mexico by maquiladora operations and other facilities established along the border with the United States. SAGARPA strongly urges that the special circumstances of food exporters located along the border with the United States that ship product by truck or train be taken into account as the FDA promulgates regulations to implement the prior notification provision of the Bioterrorism Act. Indeed, a waiver of this requirement for Mexican products shipped to the United States by truck or train may be the most appropriate way to resolve this matter. SAGARPA would appreciate the opportunity to meet with FDA officials to further develop such special rules, taking into account the special circumstances of exporters and shippers of foods products located along the border. Special rules for such shipments comport with the direction of Congress to the FDA to take into account the circumstances surrounding the importation of food products into the United States as it promulgates its regulations. In addition to the above issues, SAGARPA would further suggest that the FDA address the following issues in the regulations it promulgates to implement Section 307: 1. Use of electronic prior notification. Mexico and U.S. custom system has the ability to allow the import of a shipment with 20 minutes of notification in advance of the arrival of the shipment to the port of entry. Great efforts and resources have been used to reach such level of efficiency, with no reason to increase such notification timing. 2. Acknowledgement of receipt of prior notification. How will exporters be advised that their prior notification was received by the FDA in a timely manner? Such acknowledgment is necessary, as no exporter or shipper will want to ship product for which the FDA does not have prior notification on file and risk the detention of the shipment. 3. Shipment outside of normal port hours. How will prior notification be made outside of normal port operating hours? How will prior notification time periods be calculated in instances where shipments are made during weekends or holidays, or otherwise outside of the port working hours? 4. Non-shipment of product. What consequences will there be in instances where a prior notification has been sent to the FDA, but for reasons unanticipated at the time the notification was sent, the shipment is never sent. This is a real possibility with respect to shipments along the border, where problems such as mechanical failures of trucks may cause last minute delays in the shipments. Under such circumstances, will there be procedures to withdraw a prior notification? When the shipment is finally ready to go, will an additional prior notification need to be sent? Clarification and direction needs to be provided with respect to all of these listed issues. SAGARPA appreciates the opportunity to express its views and concerns to the FDA at this early stage of the rule-making process. SAGARPA would welcome the opportunity to meet with the appropriate FDA officials to further discuss its views and concerns. Sincerely, Enrique Lobo Minister Agricultural Office

EC -32