Food

Environmental Decision Memo for Food Contact Notification No. 000004

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or
the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.


Date: March 13, 2000

From: Environmental Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)

Subject: FCN No. 000004 - Ethylene terephthalate-isophthalate copolymers with 3 to 17% ethylene isophthalate units

Notifier: BP Amoco Chemicals
Warrenville, IL 60555-4015

To: Division of Petition Control (HFS- 215)
Attention: Julius Smith
Through: Team Leader, ERT (HFS-246)

Attached is the Finding of No Significant Impact (FONSI) for this premarket notification. The following environmental documents should be made public when this notification becomes effective:

1. The FONSI
2. The Environmental Assessment (EA) from FAP 5B4455, dated September 14, 1999. Be sure that the EA that is made public contains the documents listed in that EA's tabs as having been previously provided to FDA. If you need assistance in finding these documents, I will be glad to help. In addition, we have attached a draft document entitled "Environmental Assessment of New Polymeric Food-Packaging Materials," which should be placed with the EA's Tab 7.

Also attached is a Memorandum for the Record for this action. As noted on the memorandum, it is confidential because it is based on information the petitioner submitted to us confidentially for FAP 5B4455.

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 the FONSI.

Elizabeth Ann Cox

3 Attachments:
FONSI
Draft "Environmental Assessment of New Polymeric Food-Packaging Material"
Confidential Memorandum for the Record for FCN No. 000004


Finding of No Significant Impact

Premarket notification FCN No. 000004, submitted by BP Amoco Chemicals, to provide for the safe use of isophthalic acid or dimethyl isophthalate as a chemically-bound component of ethylene terephthalate-isophthalate copolymers containing from 3 to 17 weight percent ethylene isophthalate units manufactured by BP Amoco Chemicals as components of the base sheet or base polymer for manufacturing articles intended to 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 action was originally requested by BP Amoco Chemicals in food additive petition (FAP) 5B4455, as announced in the May 5, 1995, Federal Register (60 FR 22400). The food contact use requested in FCN No. 000004 is identical to the use requested in FAP 5B4455. Therefore, the information presented in the September 14, 1999 environmental assessment for 5B4455 is applicable to this notification and this finding is based on that information.

Prepared by_____________________________________________ Date: March 13, 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 13, 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

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