Docket Management
Docket: 02N-0277 - Bioterrorism Preparedness; Establishment and Maintenance of Records, Section 306
Comment Number: EC -24

Accepted - Volume 2

Comment Record
Commentor Mr. Enrique Lobo Date/Time 2002-08-30 18:01:10
Organization Embassy of Mexico
Category International

Comments for FDA General
1. General Comments Washington, D.C. August 29, 2002 Docket No. 02N-0277 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 - - Maintenance and Inspection of Records (Section 306) - - Docket No. 02N-0277 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 Maintenance and Inspection of Records provision (Section 303) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act of 2002”). Section 306 provides the FDA with the authority to inspect all records relating to a shipment of a food product to the United States upon reasonable notice to the exporter or importer where the FDA has a reasonable belief that the food product is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. It also directs the FDA to promulgate record keeping regulations which would permit the FDA to identify the immediate prior source of these suspect food products and the immediate subsequent recipient of the product. SAGARPA wishes to bring to the attention of the FDA the unique issues that may arise in conjunction with bulk shipments of commingled food products (e.g., grains, coffee, cocoa beans, fisheries, some fresh vegetables). It may not be possible to identify an immediate prior source for bulk shipments. Perhaps the immediate prior sources, but that could be a relatively large number. SAGARPA wishes to bring the situation to the attention to the FDA, to ensure that its regulations will specifically deal with the issue of commingled bulk shipments, and provide clear instructions and guidance to exporters and importers. SAGARPA appreciates the opportunity to express its concerns and views 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 -24