Docket Management
Docket: 02N-0275 - Bioterrorism Preparedness; Administrative Detention, Section 303
Comment Number: EC -3

Accepted - Volume 2

Comment Record
Commentor Mr. Bob Bauer Date/Time 2002-08-30 12:45:46
Organization Association of Food Industries
Category Association

Comments for FDA General
Questions
1. General Comments Docket No. 02N-0275: Comments on Detention, Public Health Security and Bioterrorism Preparedness and Response Act of 2002 President Bush signed Public Law No. 107-188 into law on June 12, 2002. The Association of Food Industries, Inc., an association of 300+ U.S. companies in the international food trade, commends FDA’s Center for Food Safety and Applied Nutrition for its wise decision to call for comments from interested parties regarding factors the agency should consider as it proceeds to draft the regulations implementing Public Law No. 107-188. AFI offers the following comments on implementation the detention provisions of Public Law No. 107-188. Timing One primary concern is the additional time involved when detentions are ordered. We are concerned the agency will not be able to meet the 24-hour limit for temporary holds and the 20-day period for other detentions. We also question the need for a 20-day hold, given that few, if any, tests on food require 20 days. However, we realize the 20-day provision is already included in the law. Reputable members of the food industry, such as members of AFI, have no problem with foods that pose a danger being detained. It is imperative, however, that a definitive determination as to whether a food poses a danger be made as quickly as possible so that food determined to be safe can be put into commerce in as close to the normal timeframe as possible to lessen the economic consequences caused by the detention. FDA should also consider that some food tolerances in the United States differ from those in other countries, meaning a product may be admissible in another country, but not in the U.S. Marking Further to the economic consequences related to detentions, we are concerned about the provision allowing a detention order to require a detained article to be labeled or marked as detained. As mentioned above, there are economic consequences each and every time a product is detained. If a product is detained and later found to be safe, markings on the products will significantly lessen the value of that product. We request FDA to ensure that any markings of detained products is temporary and in no way lessens the value of the detained product. As mentioned above, FDA should also consider that some food tolerances in the United States differ from those in other countries, meaning a product may be admissible in another country, but not in the U.S. Secure Facility The term “secure facility” must be clearly defined. It’s imperative, too, that FDA understand the costs associated with any such provision, again pertaining particularly to product that is found to be safe or product that can be reconditioned to meet U.S. standards. AFI thanks FDA for the opportunity to submit these comments. Sincerely, Robert Bauer, President Association of Food Industries




EC -3