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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000940

Date:February 12, 2010
From:Acting Supervisor, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 940 – Fluoropolymer-based oil repellent, not to exceed 0.18 percent by weight and added at either the size press or prior to sheet formation, in paper and paperboard.
Notifier:DuPont Chemical Solutions Enterprise
PO Box 80402
Wilmington, DE 19880-0402
 
To:Division of Food Contact Notifications (HFS-275)
Paul Honigfort, Ph.D.
 

The food-contact substance (FCS) is hexane, 1,6-diisocyanato-, homopolymer, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-1-octanol-blocked. A claim for categorical exclusion under 21 CFR 25.32 (i) was made for the notified use of the FCS at size press operations, where there is little opportunity for loss of the FCS, in the manufacture of paper products. The claim was made on the basis that the FCS was used as a component of a coating, which is inconsistent with the nature of its use as a grease-and-oil resistant treatment for paper products. Nonetheless, the claim is otherwise still applicable on the basis that the FCS is used at not more than five percent-by-weight and is expected to remain in the treated finished paper products.

We have reviewed the claim of categorical exclusion for the above referenced notification and have concluded that categorical exclusion is warranted based on the information provided in the notification. The claim of categorical exclusion cites the section, 21 CFR 25.32 (i), under which categorical exclusion is warranted, states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.

Attached is the Finding of No Significant Impact (FONSI) for FCN 940. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated September 30, 2009, may be made available to the public. We shall post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.

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

 

William H Lamont

 

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 940), submitted by DuPont Chemical Solutions Enterprise, to provide for the safe use of hexane, 1,6-diisocyanato-, homopolymer, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-1-octanol-blocked, as an oil repellent treatment for paper and paperboard used at a concentration not to exceed 0.18 percent by weight (weight polymer solids by weight of finished paper product) and added at either the size press or prior to sheet formation of the finished paper product.

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 information in the notification, including an environmental assessment, dated September 30, 2009, submitted by the notifier and other information known to the agency.

 

Prepared by __________________________________________Date: February 12, 2010
William H Lamont, Acting Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration