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CFSAN/Office of Food Additive Safety
May 10, 2002
Date: May 10, 2002
From: Environmental Chemist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 224 - 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate as a plasticizer in vinyl chloride polymers
Notifier: Eastman Chemical Company
c/o Keller and Heckman
Washington DC, 20001
To: Division of Food Contact Substance Notification Review (HFS-275)
Attention: Parvin Yasaei, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG
Attached is the Finding of No Significant Impact (FONSI) for this food contact notification. When this notification becomes effective, the following documents will be available to the public:
1. This FONSI;
2. The notifier's EA, dated March 28, 2002.
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 this FONSI.
John Dennison
A food contact notification (FCN No. 224), submitted by Eastman Chemical Company, to provide for the safe use of 2,2,4-trimethyl-1,3-pentanediol diisobutyrate (TXIB) as a plasticizer in vinyl chloride polymers in repeated-use food-contact applications and in vinyl chloride polymer-based gloves used to process food.
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 March 28, 2002.
Prepared by___________________________________________ Date: May 10, 2002
John Dennison, Environmental Chemist
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: May 10, 2002
Layla 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
