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CFSAN/Office of Food Additive Safety
March 23, 2000
Date: March 23, 2000
From; Environmental Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)
Subject: Premarket Notification FCN No. 000013 - PEN/PET Copolymers with <50% PEN
Notifier: BP Amoco Chemicals
Warrenville, IL 60555-4015
To: Division of Product Policy (HFS-205)
Attention: Hortense Macon
Through: Team Leader, ERT (HFS-246)
Attached is the finding of no significant impact (FONSI) for this premarket notification. When this notification becomes effective, this document should be made available to the public. The environmental assessment (EA) on which the environmental decision for this notification is based (the EA for FAP 5B4450) is already available to the public.
Elizabeth Ann Cox
Premarket notification FCN No. 000013, submitted by BP Amoco Chemicals, to provide for the safe use of dimethyl 2,6-naphthalenedicarboxylate or 2,6-naphthalenedicarboxylic acid as a chemically-bound component of ethylene terephthalate-2,6-naphthalate copolymers, which finished copolymers may contain from 0 to 50 weight percent of copolymer units derived from ethylene 2,6-naphthalate.
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 action is part of an action originally requested in food additive petition (FAP) 5B4450. The agency announced the filing of FAP 5B4450 in the June 22, 1995, Federal Register (60 FR 32526). In November of 1999, FAP 5B4450 was converted into a premarket notification, FCN No. 000008. At that same time this notification, FCN No.000013, was submitted. The food contact use requested in FCN No. 000013 is part of the use requested in FCN No. 000008. Specifically, the use requested in FCN No. 000008 involves the use in contact with food of the subject copolymers that are manufactured by Shell Chemicals Company, while the use requested FCN No. 000013 involves the manufacture by the notifier of one of the monomers of the subject copolymers. Additionally, the environmental documentation submitted to the agency for FAP 5B4450 was prepared as a cooperative effort by the notifier of FCN No. 000008, Shell Chemicals Company, and the notifier of FCN No. 000013. Thus, the information in the environmental record for FCN No. 000008 is also applicable to this notification. On March 2, 2000, the agency prepared a finding of no significant impact (FONSI) for FCN No. 000008. This FONSI for FCN No. 000013, is based on the same information as is the FONSI for FCN No. 000008. The publicly available parts of the environmental record for FCN No. 000008 consists of three documents: an environmental assessment dated August 4, 1999, which is displayed at the Dockets Management Branch, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, under Docket Number 95F-0130; a supplement to the environmental assessment for FCN No. 000008 prepared by the Environmental Review Team; and the FONSI for FCN No. 000008.
Prepared by: Date: March 23, 2000
Elizabeth Ann Cox, Environmental 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: March 23, 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
