Docket Management
Docket: 02N-0277 - Bioterrorism Preparedness; Establishment and Maintenance of Records, Section 306
Comment Number: EC -22

Accepted - Volume 2

Comment Record
Commentor Mr. Kazuhisa Takahashi Date/Time 2002-08-30 16:42:53
Organization Japanese Embassy
Category International

Comments for FDA General
1. General Comments 2. Section 306 (1) FDA should only require minimum information necessary to be kept as record, so that it does not create an undue burden on private businesses. (2) FDA should give appropriate guidance to private businesses for establishing and maintaining the records smoothly, for example, by showing a model of how records should be kept. (3) FDA should exempt companies that deal with or import food less than a certain amount of volume from the obligation of establishing and the maintaining records under this section. (4) Contents of the record required by the Bioterrorism Act should be within those required by current 21 CFR113, 21CFR114, and 21CFR123 for the seafood HACCP regulations. (5) FDA should only require that a record of major ingredients be kept as a record of raw materials. (6) We understand that FDA will establish grequirements for the creation and the maintenance of records needed to determine the immediate previous sources and the immediate subsequent recipients of food (i.e., one up, one down)h at the manufacturing facilities. In this context, FDA should not require further information on business contacts of food facilities to be kept. (7) FDA should not require manufacturing and processing records of fresh agricultural products that are sold as such on the market.

EC -22