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CFSAN/Office of Food Additive Safety
April 25, 2002
Date: April 25, 2002
From: Environmental Scientist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 201 - 2H-Benzimidazole-2-thione, 1,3-dihydro-, 4 (or 5)- methyl-, zinc salt (2:1) as an antioxidant synergist in natural or synthetic rubber gloves for single use in the meat packing industry
Notifier: R.T. Vanderbilt Co., Inc.
30 Winfield Street
Norwalk, CT 06855
To: Division of Food Contact Substance Notification
Attention: William Trotter, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG
Attached is the Finding of No Significant Impact (FONSI) for this premarket notification. When this notification becomes effective, this FONSI and the notifier's environmental assessment, dated January 22, 2002, 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.
Paul C. DeLeo, Ph.D.
A food contact notification (FCN No. 201), submitted by R.T. Vanderbilt Company to provide for the safe use of 2H-benzimidazole-2-thione, 1,3-dihydro-, 4 (or 5)-methyl-, zinc salt (2:1) as an antioxidant synergist in natural or synthetic rubber gloves for single use in the meat packing industry. The limitations of use are described in the March 18, 2002, acknowledgment letter to the Notifier.
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 January 22, 2002.
Prepared by __________________________________________ Date: April 10, 2002
Paul C. DeLeo, Ph.D., 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: April 10, 2002
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