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CFSAN/Office of Food Additive Safety
December 17, 2003
Date: December 17, 2003
From: Environmental Scientist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 387 - Siloxanes and silicones for use as a defoamer in the pulping of lignocellulosic materials that will be used to make food contact paper and paperboard
Notifier: General Electric Company
Tarrytown, NY 10591-6728
To: Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG
Attached are the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment for FCN 387. When this notification becomes effective, these documents and the notifier's environmental assessment, dated September 12, 2003, 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.
Jonathan L. Chappell
2 Attachments:
Finding of No Significant Impact
Supplement to the Environmental Assessment for FCN 387
A food contact notification (FCN No. 387), submitted by General Electric Company, to provide for the safe use of siloxanes and silicones, di-Me, polymers with silica-1,1,1-trimethy -N-(trimethylsilyl)silanamine hydrolysis products and silicic acid trimethylsilyl ester as a defoamer in the pulping of lignocellulosic materials that will be used to make food contact paper and paperboard.
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 dated September 12, 2003, and on information in a supplement to the notifier=s environmental assessment that was prepared by the agency.
Prepared by ______________________________________ Date: December 17, 2003
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: December 17, 2003
Layla I. Batarseh, Ph.D., 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
This document incorporates by reference the notifier's environmental assessment (EA) dated September 12, 2003.
The notifier calculated the environmental introduction concentration (EIC) and the expected environmental concentration (EEC) assuming that pulp slurry contains only 0.5% pulp. However, typically, the pulp is dispersed at a consistency of approximately 0.5% to 1%, so we calculated and EIC and EEC assuming that pulp slurry will contain 1% pulp as a worst-case estimate.
The notifier calculated that the EIC of the FCS in white water or paper mill effluent to be 250 ppb if the pulp slurry contains 0.5% pulp (see page 6 of the EA). Based on this estimate, the EEC of the food contact substance (FCS) in receiving water is 25 ppb, using conservative dilution factor of 10. Using 1% pulp in the pulp slurry, we calculated the EIC in paper mill effluent to be 490 ppb, and the EEC in receiving water to be 49 ppb as a worst-case estimate.
Conclusion
Based on the small introduction of the FCS to aquatic environments in relation to the ecotoxicity endpoints supplied by the notifier in the environmental assessment, we believe that there would be no potential for significant adverse environmental impacts due to the worst-case expected release of this FCS into the environment as a result of the use proposed in FCN 387.
Prepared by_______________________________________ Date: December 17, 2003
Jonathan L. Chappell, Environmental Scientist
