Food
Environmental Decision Memo for Food Contact Notification No. 000321
Date: May 7, 2003
From: Environmental Scientist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN 321 - SEPTON 2007TM for use as a component of food-contact articles
Notifier: Kuraray America, Inc.
Kuraray Co., Ltd.
Kuraray Europe, GmbH, and
SEPTON Company of America
To: Division of Food Contact Notifications (HFS-275)
Attention: Kelly Williams Randolph, DVM
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, this FONSI and the notifier's environmental assessment 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.
Finding of No Significant Impact
A premarket notifiction (FCN 321), submitted by Kuraray America, Inc.; Kuraray Co., Ltd; Kuraray Europe, GmbH; and the SEPTON Company of America, to provide for the safe use of hydrogenated styrene-isoprene block copolymer with 2-methyl-1,3-butadiene (SEPTON 2007J) as a component of food contact articles.
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 9, 2003.
Prepared by: _________________________________ Date: May 7, 2003
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: May 7, 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







