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Environmental Impact Decisions for Food Contact Substance Notifications or
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Date: October 28, 2009
From: Acting Supervisor, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject: FCN No. 933 - Fluorochemical copolymer as an oil and grease resistant treatment for paper and paperboard.
Notifier: Daikin America, Inc.
905 State Docks Road
Decatur, AL 35601
To: Division of Food Contact Notifications (HFS-275)
Attention: Kelly Randolph, D.V.M., M.P.H.
The food contact substance (FCS) is 2-propenoic acid, 2-methyl-, polymer with 2-hydroxyethyl 2-methyl-2-propenoate, α-(1-oxo-2-propen-1-yl)-ω-hydroxypoly(oxy-1,2-ethanediyl), and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate, sodium salt. The FCS is employed at the size press or is added prior to sheet formation in the production of paper and paperboard.
The notifier submitted a claim of categorical exclusion under 21 CFR 25.32(i) for the proposed use of the FCS at the size press in production of paper products. We have reviewed the claim of categorical exclusion and have concluded that categorical exclusion is warranted. 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 for the proposed use of the FCS at the size press.
Also, the notifier submitted an environmental assessment for the proposed use of the FCS added in production operations prior to formation of paper sheet. We have reviewed the environmental assessment, and we have prepared the attached Finding of No Significant Impact (FONSI) for FCN 933. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated August 31, 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
Finding of No Significant Impact
Finding of No Significant Impact
A food contact notification (FCN No. 933), submitted by Daikin America, Inc., to provide for the safe use of 2-propenoic acid, 2-methyl-, polymer with 2-hydroxyethyl 2-methyl-2-propenoate, α-(1-oxo-2-propen-1-yl)-ω-hydroxypoly(oxy-1,2-ethanediyl), and 3,3,4,4,5,5,6,6,7,7,8,8,8-trideca-fluorooctyl 2-propenoate, sodium salt, as an oil and grease resistant treatment for paper and paperboard.
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, submitted by the notifier, in an environmental assessment, dated August 31, 2009, and other information known to the agency.
Prepared by __________________________________________Date: October 28, 2009
William H Lamont, Acting Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration