Docket Management
Docket: 02N-0275 - Bioterrorism Preparedness; Administrative Detention, Section 303
Comment Number: EC -14

Accepted - Volume 2

Comment Record
Commentor Mr. Enrique Lobo Date/Time 2002-08-30 18:06:38
Organization Embassy of Mexico
Category International

Comments for FDA General
1. General Comments Washington, D.C. August 29, 2002 Docket Nos. 02N-0275 Through 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 - - Docket Nos. 02N-0275 Through 02N-0278 Dear Mr. Levitt: The Secretaria de Agricultura, Ganaderia, Desarrollo Rural, Pesca Y Alimentacion (“SAGARPA”) of the Government of Mexico, is submitting herewith comments identifying its principal concerns over the implementation of the Administrative Detention (Section 303), Registration (Section 305), Record Keeping (Section 306), and Prior Notice (Section 307) provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act of 2002”). These comments are contained in the four attached letters. In addition to the specific concerns addressed in these four letters, SAGARPA also has a number of more general concerns regarding the Bioterrorism Act of 2002, and its potential affect on Mexico’s exports of food products to the United States. While recognizing the need for the United States to take steps to reduce the risk of bioterrorism, SAGARPA is concerned that some of the provisions enacted by the Congress in the Bioterrorism Act could be used (or abused) to raise non-tariff barriers to trade in food products. To the extent these measures become, or are used as, non-tariff barriers to trade, they would run afoul of the United States’ World Trade Organization obligations. SAGARPA urges the FDA to ensure that when promulgating regulations to implement the Bioterrorism Act, it not lose sight of the Act’s intended purpose - - to reduce the risk of bioterrorism in the United States, and not to let the Act be used to create non-tariff barriers to imports. SAGARPA’s other major concern arises from the fact that Mexico is the only country (other than Canada) that shares a land border with the United States, and which ships most of its exports of food product to the United States by truck or train, rather than by ship or plane. Many of the provisions in the Bioterrorism Act of 2002 appear to be addressed to shipments of food product made by either ship or plane. Little consideration appears to have been given to the unique issues arising from the land shipment of product - - particularly when, as in the case of Mexico, a large portion of the products covered by they Act are shipped from facilities located within a few miles of the U.S. border. The Bioterrorism Act of 2002 also fails to take into account that certain countries, such as Mexico, have a long history of close cooperation with the United States in the food safety area, and that many of the concerns and issues that the Act is designed to address simply do not exist with Mexico. For this reason, SAGARPA believes consideration should be given to a request to waive the requirements contained in the Bioterrorism Act of 2002 for Mexican facilities and Mexican shippers and exporters. In the absence of such a waiver, special rules will need to be developed to take into account the unique aspect of Mexico’s exports of food products to the United States. SAGARPA would welcome the opportunity to discuss these matters further with the FDA. SAGARPA thanks the FDA for its consideration of the comments presented herein, and in the four attached letters. Sincerely, Enrique Lobo Minister Agricultural Office

EC -14