|
CFSAN/Office of Food Additive Safety
April 14, 2000
Date: April 14, 2000
From: Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)
Subject: Premarket Notification- FCN 000028 - Hydrogenated Styrene-Butadiene Block Polymers Modified with Maleic Anhydride for Food Contact Use
Notifier: Asahi Chemical Industrial Co., Ltd.
c/o Regulatory Assistance Corp.
7 Clearview Circle
Hopewell Junction, NY 12533
To: Division of Petition Control (HFS-215)
Attention: Andrew Zajac, Ph.D
Through: Team Leader, ERT (HFS-246)
Attached to this memorandum is the Finding of No Significant Impact (FONSI) for the above cited premarket notification. The following environmental documents should be made public when this notification becomes effective:
1. This FONSI.
2. The revised EA from FAP 3B4354, dated January 7, 2000.
Please note that pages 13 and 14 in the revised EA contain the confidential environmental information and should not be made available to the public.
Hardy J. Chou, Ph.D.
A Premarket Notification (FCN 000028), submitted by Asahi Chemical Industry Co., Ltd., to provide for the safe use of hydrogenated styrene-butadiene block polymers modified with maleic anhydride such that the basic polymers are composed of 18 to 40 percent by weight of units derived from styrene, 58 to 80 percent by weight of units derived from 1,3-butadiene and up to 2 percent by weight of units derived from maleic anhydride as components of articles that contact food.
The Environmental Review Team 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 Asahi Chemical Industry Co., Ltd. in a revised environmental assessment (EA) for Food Additive Petition (FAP) 3B4354.
This action was originally requested by Asahi Chemical Industrial Co., Ltd., in FAP 3B4354 as announced in the Federal Register on November 17, 1994 (59 FR 59410). The food contact use requested in FCN No. 000028 is identical to the food contact use requested in FAP 3B4354. Therefore, the information provided in the EA for FAP 3B4354 is applicable to this notification.
Prepared by: ____________________________________________ Date: April 14, 2000
Hardy J. Chou, Ph.D, Chemist
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by: ___________________________________________ Date: April 14, 2000
Buzz L. Hoffmann, Ph.D., Team Leader
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration
