Environmental Decision Memo
for Food Contact Notification No. 000052

Date: April 27, 2000

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

Subject: Premarket Notification FCN No. 000052 - A high density agarose resin for use in the isolation and purification of food enzymes

Notifier: Chr. Hansen A/S
Hoersholm DK-2970
Denmark

To: Division of Petition Control (HFS-215)
Attention: Edward 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 21, 2000 - Revised: April 4, 2000, should be made public when this notification becomes effective.

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.

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Finding of No Significant Impact

A Premarket Notification (FCN No. 000052), submitted by Chr. Hansen A/S, for a high density agarose resin that is cross-linked and alkylated with epichlorohydrin followed by chemical binding of the ligand benzylamine for repeat use in the form of beads as an adsorbent in a chromatographic process intended for the isolation and purification of food enzymes.

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 21, 2000 B revised April 4, 2000, that was prepared by the notifier.

Prepared by: ___________________________________________ Date: April 27, 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 27, 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