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CFSAN/Office of Food Additive Safety
August 15, 2000
Date: August 15, 2000
From: Chemistry and Environmental Review Team
Division of Product Policy (HFS-205)
Subject: Premarket Notification for FCN No. 000073 - Epoxy Resin Coatings Complying with 21 CFR 175.300 That Also Contain Polyoxypropylenediamine as a Cross Linking Component
Notifier: Belzona, Inc.
Americas Gateway Park
Miami, FL 33172
To: Division of Petition Control (HFS-215)
Attention: Mark A. Hepp, Ph.D.
The attached Finding of No Significant Impact (FONSI) supersedes the July 12, 2000, FONSI for the above cited Premarket Notification. When this notification becomes effective, the notifier's environmental assessment (EA), the attached supplement to the EA for this premarket notification, and this FONSI may be made available to the public. Please let me know if there is any change in the identity or use of the food contact substance that would be inconsistent with the identity and use described in the FONSI.
Layla I. Batarseh, Ph.D.
A Premarket Notification (FCN No. 000073), submitted by Belzona, Inc., to provide for the safe use of epoxy resin coatings that also contain polyoxypropylenediamine as a cross-linking component
The Chemistry and Environmental Review Team has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and therefore will not require the preparation of an environmental impact statement. This finding is based on an environmental assessment prepared by the notifier and on a supplemental environmental assessment prepared by a scientist on the Chemistry and Environmental Review Team.
Prepared by: ________________________________________ Date: August 15, 2000
Layla I. Batarseh, Ph.D., Team Leader
Chemistry and Environmental Review Team
Division of Product Policy
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration
This document incorporates by reference the notifier's environmental assessment dated June 12, 2000.
In our acknowledgment letter to the notifier, the agency identified polyoxypropylene-diamine as the food contact substance for this notification. However, Belzona, Inc., indicated that the company manufactures the epoxy resin coatings and not polyoxy-propylenediamine. Consequently, the agency has revised the description of the food contact substance as the epoxy resin coatings that also contain polyoxypropylene-diamine as a cross linking component. This change does not affect the analysis in the EA supporting the notifier's contention that allowing this notification to become effective will not have a significant impact on the human environment.
