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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000460

Date: November 2, 2004

 

From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)

 

Subject: FCN No. 460 - Benzethonium chloride for use as an antibacterial agent in no-rinse hand sanitizers for food handlers

 

Lonza, Inc.
17-17 Route 208
Fair Lawn, NJ 07410

 

To: Division of Food Contact Notifications (HFS-275)
Attention: Mark A. Hepp, Ph.D.
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 (EA) for FCN 460. When this notification becomes effective, these documents and the notifier's revised EA, dated September 29, 2004, 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.

 

 

 

 

Tong Zhou, Ph.D.

 

 

2 Attachments

 





Finding of No Significant Impact

A food contact notification (FCN No. 460), submitted by Lonza, Inc., to provide for the safe use of benzethonium chloride USP, also known as benzenemethanaminium, N-N-dimethyl-N-(2-(2-(4-(1,1,3,3,-tetramethylbutyl)phenoxy)ethoxy)-ethyl)-, chloride, as an antibacterial agent in no-rinse hand sanitizers for food handlers

 

 

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 September 29, 2004, and our supplement to that EA.

 

 

 

Prepared by __________________________________________Date: November 2, 2004
Tong Zhou, Ph.D., Environmental Toxicologist
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: November 2, 2004
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