Docket Management
Docket: 02N-0275 - Bioterrorism Preparedness; Administrative Detention, Section 303
Comment Number: EC -13

Accepted - Volume 2

Comment Record
Commentor Mr. Enrique Lobo Date/Time 2002-08-30 18:04:28
Organization Embassy of Mexico
Category International

Comments for FDA General
Questions
1. General Comments Washington, D.C. August 29, 2002 Docket No. 02N-0275 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 - - Administrative Detention (Section 303) - - Docket No. 02N-0275 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 Administrative Detention provision (Section 303) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act of 2002”). Section 303 provides authority for the FDA to detain food products for up to thirty days to determine if the product has been adulterated, where there is “credible evidence or information” indicating that the food product presents a threat of serious adverse health consequences or death to humans or animals. It also provides for temporary holds of up to 24 hours at the port of entry to enable a more thorough inspection of the product. While understanding the need for this authority, SAGARPA’s major concern is how perishable food will be treated. While new Section 303(h)(2) of the Food, Drug and Cosmetic Act (“FDCA”) recognizes a need for expedited treatment for perishable goods, it does not specify what this means. Given the short life span of perishable food products, any detention period in excess of 1 hour will likely result in the product losing most, if not all, of its commercial value. Therefore, SAGARPA requests that the FDA regulations provide that the 20 – 30 day period which the statute permits the FDA to detain food products to determine whether to act either under Section 334(a) or Section 302 of the FDCA be reduced to no more than 24 hours in the case of perishable foods. SAGARPA further request that “perishable “ foods be defined by reference to the definition contained in the Perishable Agricultural Commodities Act of 1930. Meat, poultry, egg and egg products also must be included in this definition. Such regulatory guidance would comport with the Bioterrorism Act’s instruction to provide for procedures to deal with perishable foods on an “expedited basis”. In addition, SAGARPA would suggest that the regulations provide that perishable goods be immediately moved to refrigerated facilities during the period that they are being detained, prior to a decision by the FDA on whether the goods should be admitted. This will minimize the spoilage caused by the wait for the FDA inspection and determination of admissibility. Given the extreme heat along the U.S. – Mexico border (especially in the summer months), the failure to provide for refrigerated storage for perishable foods will in most case result in the spoilage of the foods, even if detained for a 24 hours period. This concern expressed above with respect to perishable goods is actually only part of a more general concern of SAGARPA with respect to how goods will be kept while being detained. While the statute speaks of secure facilities, SAGARPA believes that the FDA regulations must provide that the detained foods be kept in facilities that will ensure that the foods will not spoil or otherwise deteriorate during the detention period. This means that foods products which require refrigeration should be kept in refrigerated facilities, and frozen food products (or other products that require freezing) should be kept in freezer facilities. Otherwise, regardless of the condition of the food at the time of entry, in many cases it will be adulterated and unfit for consumption at the end of a 20 or 30 day detention period, considering the reduction of damages and shrinks to the product. SAGARPA also believes that the FDA regulations should provide for a notification procedure to ensure that importers and exporters, and the agency in the government of the country of origin, are immediately advised that their products are being detained pursuant to the provision of the Bioterrorism Act of 2002, and provide an explanation of the reasons forming the basis for such detention. Further, expedited procedures should be provided which will allow an exporter or importer to immediately provide information to the FDA to clarify any misunderstandings or mistakes which have caused goods to be detained erroneously. (This concern arises from the absence of such procedures in the case of erroneous seizures of goods by the U.S. Customs Service, resulting in importers often having to wait weeks to obtain the release of goods which even the Customs Service acknowledges were erroneously or mistakenly seized.) In such cases, it does not seem fair to make an importer wait perhaps 20 or 30 days for a determination to be made and its goods released. Finally, SAGARPA, while conceding the need for extreme vigilance in the area of food safety, believes some safeguards need to implemented by the FDA to ensure that Section 303 is not used by inspectors in the field as a “catch-all” basis for detention of foods products imported into the United States. Widespread application of this provision, beyond the bounds that Congress intended, would not only be unfair to importers and exporters, but would also severely dilute the effectiveness of this provision in guarding against the dangers posed by bioterrorism. 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 -13