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U.S. Department of Health and Human Services


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Environmental Decision Memo for Food Contact Notification No. 000099

Date: October 2, 2000


From: Chemistry and Environmental Review Team
Division of Product Policy (HFS-205)


Subject: Premarket Notification (FCN No. 000099) - Use of a Mixture of Methylhydantoins as an Adjuvant in Bleaching Recycled Paper


Notifier: Lonza, Inc.
c/o Lewis & Harrison
Washington, DC 20001


To: Division of Petition Policy (HFS-206)
Attention: Hortense Macon



Attached is the Finding of No Significant Impact (FONSI) for the above cited Premarket Notification. When this notification becomes effective, the notifier's environmental assessment and this FONSI may be made available to the public. Please let me 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.





Layla I. Batarseh, Ph.D.






Finding of No Significant Impact

A Premarket Notification (FCN No. 000099), submitted by Lonza, Inc., to provide for the safe use of a mixture of 1,3-bis (hydroxymethyl)-5,5-dimethylhydantoin and hydroxymethyl-5,5-dimethylhydantoin as an adjuvant in the bleaching of recycled paper.



The Chemistry and 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 September 15, 2000, prepared by the notifier.




Prepared by: __________________________________________ Date: October 2, 2000
Layla I. Batarseh, Ph.D., Team Leader
Chemistry and Environmental Review Team
Division of Product Policy
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration