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CFSAN/Office of Food Additive Safety
February 2, 2000
Date: February 2, 2000
From: Environmental Scientist, Chemistry and Environmental Review Team (CERT)
Scientific Support Branch (HFS-207)
Subject: FCN 000018 - Sodium Acrylate/Styrene Sulfonate Copolymer as an Antiscalant in Boiler Water
Notifier: Nalco Chemical Company
Naperville, Il 60563
To: Division of Petition Control (HFS-215)
Attention: Parvin Yasaei
Through: Team Leader, Environmental Impact Team
Attached is the Finding of No Significant Impact (FONSI) for this Premarket Notification. The following environmental documents should be made public when this notification becomes effective.
1. This FONSI.
2. The Environmental Assessment for FAP 8A4598, dated May 8, 1998, and the Nalco Analytical Laboratory Report No. 208399, received on May 28, 1998. These documents should be displayed under Docket No. 98F-0430 for FAP 8A4598.
3. Our supplement to the Environmental Assessment for FAP 8A4598, dated December 10, 1998.
4. The Material Safety Data Sheets provided as Attachment 6 to the April 8, 1999, Addendum to FAP 8A4598.
Jeanette Glover Glew
A Premarket Notification (FCN No.000018), submitted by Nalco Chemical Co., to provide for the safe use of sodium acrylate/styrene sulfonate copolymer for use as an antiscalant boiler treatment where steam from treated boilers may contact food.
The Chemistry and Environmental Review Team, Division of Product Policy, 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 Nalco Chemical Company in a food additive petition (FAP 8A4598), as announced in the June 30, 1998, Federal Register (63 FR 35603). The food contact use requested in the notification is identical to the use requested in FAP 8A4598. Therefore, the information presented in the Environmental Assessment for FAP 8A4598 is applicable to this notification, and this finding is based on that information and on the analysis in a supplement to the EA.
Prepared by: ________________________________________ Date: February 2, 2000
Jeanette Glover Glew, Environmental Scientist
Chemistry and Environmental Review Team
Scientific Support Branch
Division of Product Policy
Center for Food Safety and Applied Nutrition
Food and Drug Administration
December 10, 1998
This document incorporates by reference the petitioner's environmental assessment (EA) for Food Additive Petition 8A4598, dated May 8, 1998.
The petitioner's estimate of the expected concentration of the additive introduced into the environment (EIC) at the site of use was based on 12 cycles of circulation of the boiler water. However, a scientist in the Chemistry Review Branch said that conservative estimates of the boiler water concentration of the additive are based on 100 cycles of circulation. Based on 100 cycles of circulation, the EIC was still several orders of magnitude lower than the reported endpoint for the most sensitive aquatic organism (i.e. > 1,000 mg/L).
Jeanette Glover Glew
