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CFSAN/Office of Food Additive Safety
March 7, 2001
Date: March 7, 2001
From: Environmental Scientist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 211 - Isophthalic acid as a monomer in the manufacture of ethylene terephthalate-isophthalate copolymers
Notifier: Eastman Chemical Company
Kingsport, TN 37662
To: Division of Food Contact Substance Notification Review (HFS-275)
Attention: William Trotter, Ph.D.
Through: Layla Batarseh, Supervisor, ERG
Attached is the Finding of No Significant Impact (FONSI) for this premarket notification. When this notification becomes effective, the following documents may be made available to the public:
1. The FONSI;
2. The notifier's submission dated January 22, 2002; and
3. The notifier's submission dated February 11, 2002.
Please let us know if there is any change in the identity or use of the food-contact substance.
Jeanette Glover Glew
Attachment
A food contact notification (FCN No. 211), submitted by Eastman Chemical Company, to provide for the use of isophthalic acid as a monomer in the manufacture of ethylene terephthalate-isophthalate copolymers containing from 3 to 17 weight percent ethylene isophthalate units meeting the specifications as described in 21 CFR 177.1630 (f) - (j).
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 on January 2 and February 11, 2002.
Prepared by: __________________________________________ Date: March 7, 2002
Jeanette Glover Glew, 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: March 7, 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