Environmental Decision Memo
for Food Contact Notification No. 000039

Date: April 19, 2000

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

Subject: Premarket Notification FCN No. 000039 - Irganox MD 1024 for Use as a Stabilizer for Olefin Polymers

Notifier: Ciba Specialty Chemicals Corp.
540 White Plains Road
Tarrytown, NY 10591

To: Division of Petition Control (HFS-215)
Attention: Ed Machuga
Through: Team Leader, ERT

Attached is our Finding of No Significant Impact (FONSI) for the above cited Premarket Notification. The FONSI and the notifier's Environmental Assessment, dated March 17, 2000, should be made public when this notification becomes effective.

Please let is 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.

---

Finding of No Significant Impact

A Premarket Notification (FCN No. 000039), submitted by Ciba Specialty Chemicals Corporation, for the safe use of benzene-propanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-2-[3-[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]-1oxopropyl] hydrazide, as a stabilizer for olefin polymers.

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 an environmental assessment, dated March 17, 2000, prepared by the notifier.

Prepared by: ___________________________________________ Date: April 18, 2000
Sylvia G. Matson, Program Specialist
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 19, 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