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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000475

 

Date: November 29, 2004
From: Environmental Scientist, Environmental Review Group
Division of Chemistry Research and Environmental Review
Subject: FCN No. 475 - Polylactide polymers (PLA) comprised of up to 16% D-lactic acid polymer units for use in the manufacture of food contact articles.
Notifier: Cargill Dow LLC
Minnetonka, MN 55345-1512
To: Division of Food Contact Notifications (HFS-275)
Attention: Vivian Gilliam
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

Attached is the Finding of No Significant Impact (FONSI) for FCN 475. When this notification becomes effective, this FONSI and the notifier's environmental assessment, dated October 12, 2004, may be made available to the public.

Please let us know if there is any change in the identity or use of the food contact substance.

 

Jonathan L. Chappell

 

Attachment

 


Finding of No Significant Impact

A food contact notification (FCN No. 475), submitted by Cargill Dow LLC, to provide for the safe use of polylactide polymers (PLA) comprised of up to 16% D-lactic acid polymer units (also referred to as "High D PLA") as components of food-contact articles for use in contact with all food types under Conditions of Use C through G, as described in 21 CFR 176.170(c), Table 2.

The Environmental Review Group 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 information submitted by the notifier in an environmental assessment dated October 12, 2004.

 

Prepared by ___________________________________________ Date: November 29, 2004
Jonathan L. Chappell, Environmental Scientist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by ____________________________________________ Date: November 29, 2004
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration