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CFSAN/Office of Food Additive Safety
March 20, 2000
Date: March 20, 2000
From: Environmental Scientist, Chemistry and Environmental Review Team, (CERT)
Scientific Support Branch (HFS-207)
Subject: FCN No. 000030 - Copolymer of the Sodium Salt of Acrylic Acid with Polyethyleneglycol Allyl Ether for Use as a Boiler Water Additive
Notifier: BetzDearborn, Inc.
Trevose, PA 19053
To: Division of Petition Control (HFS-215)
Attention: Paulette Gaynor, Ph.D.
Through: Team Leader, Environmental Impact Team
This memorandum and the attached Finding of No Significant Impact (FONSI) supersede our memorandum and FONSI of February 2, 2000. The following environmental documents should be made public when this notification becomes effective.
1. This FONSI.
2. The revised environmental assessment (EA) from FAP 7A4541 dated March 15, 2000, including the updated MSDS for Rhodasurf AAE 10, which was attached to the February 11, 1998 EA.
Please do not make public the environmental information submitted in Appendix 1 (Polymer active concentration and estimated polymer usage), which was initially submitted as part of the EA dated March 14, 1997.
Jeanette Glover Glew
Premarket Notification FCN No. 000030, submitted by BetzDearborn, a division of Hercules, Inc., to provide for the safe use of the copolymer of the sodium salt of acrylic acid with polyethyleneglycol allyl ether for use in boilers where steam may contact food.
The Chemistry and Environmental Review Team, Division of Product Policy, Center for Food Safety and Applied Nutrition, 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 action was originally requested by BetzDearborn, Inc. in Food Additive Petition (FAP) 7A4541, as announced in the May 9, 1997, Federal Register (62 FR 25633). The food-contact use requested in FCN No. 000030 is identical to the food-contact use requested in FAP 7A4541. Therefore, the information presented in the environmental assessment for FAP 7A4541 is applicable to this notification, and this finding is based on that information and on confidential information submitted by BetzDearborn, Inc., regarding the projected market volume.
Prepared by: ___________________________________________ Date: March 17, 2000
Jeanette Glover Glew, Environmental Scientist
Chemistry and Environmental Review Team
Division of Product Policy
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration
