Environmental Decision Memo for Food Contact Notification No. 000059
Date: May 19, 2000
From: Chemistry and Environmental Review Team
Division of Product Policy (HFS-205)
Subject: Premarket Notification (FCN No. 000059) for Perflouroalkyl Substituted Carboxylic Acid as Oil and Water Repellent for Paper and Paperboard
Notifier: Ciba Specialty Chemicals Corporation
High Point, NC 27261-2444
To: Division of Petition Control (HFS-215)
Attention: Ed Machuga
Attached is the Finding of No Significant Impact (FONSI) for the above cited Premarket Notification. When this notification becomes effective, the EA and FONSI should 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.
Finding of No Significant Impact
A Premarket Notification (FCN No. 000059), submitted by Ciba Specialty Chemicals Corporation, to provide for the safe use of Glycine, N, N-bis[2-hydroxy-3-(2-propenyloxy) propyl]-, monosodium salt, reaction products with ammonium hydroxide and pentafluoroiodoethane-tetrafluoroethylene telomer (CAS Reg. No. 220459-70-1) as an oil and water repellant for paper and paperboard complying with 21 CFR Part 176.170(a)(5).
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.
Prepared by: ____________________________________________ Date: May 19, 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