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Environmental Decision Memo for Food Contact Notification No. 000173

Date: October 30, 2001

 

From: Environmental Scientist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review

 

Subject: FCN No. 173 - Carbopol® Polyacrylic Acid Homopolymer or Copolymer of Acrylic Acid

 

 

Notifier: Noveon, Inc.
c/o Keller and Heckman
Washington, DC 20001

 

To: Division of Food Contact Notification
Attention: Mark Hepp
Through: Acting Supervisor, ERG

 

 

Attached is the Finding of No Significant Impact (FONSI) for this premarket notification. When this notification becomes effective, this FONSI, the notifier's August 17, 2001, Environmental Assessment (EA) and our Supplement to the EA may be made available to the public.

 

Please let us 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.

 

 

 

Jonathan L. Chappell

 

 





Finding of No Significant Impact

A food contact notification (FCN No. 173), submitted by Noveon, Inc., to provide for the safe use of polyacrylic acid homopolymer or copolymer of acrylic acid in hand sanitizers intended for use in food service establishments.

 

The Environmental Review Group 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 information submitted by the notifier in an environmental assessment (EA) dated August 17, 2001 and our supplement to that EA.

 

 

 

Prepared by________________________________________ Date: October 30, 2001
Jonathan L. Chappell, Environmental Scientist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 

 

Approved by________________________________________ Date: October 30, 2001
Jeanette Glover Glew, Acting Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 





Supplement to the Environmental Information
for Food Contact Notification No. 173

 

This document incorporates by reference the notifier's environmental assessment (EA) dated August 17, 2001.

 

In format item 7 of the EA, the notifier provided a expected environmental concentration (EEC) of 0.03 ppm. However, the notifier did not compare this EEC to a relevant toxic endpoint under format item 8. Normally, some sort of comparison is required in order to determine the potential for significant environmental effects. However, we believe that this substance will not have a significant effect on the human environment for the following reasons:

 

1) The EEC calculated by the notifier is an extremely conservative estimate that is based on high rates of land application of biosolids. We would expect the actual EEC based on the proposed food contact use and average rates of land application to be much lower.

2) Based on experience with evaluating the environmental impact of biosolids in previous environmental assessments, we believe that this substance likely will be tightly bound in soil and not be available to adversely affect organisms.

3) While no relevant environmental toxic endpoints were provided by the notifier, the mammalian studies provided for this food contact substance showed a low level of toxicity.

 

 

Prepared by___________________________________________ Date: October 30, 2001
Jonathan L. Chappell, Environmental Scientist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration