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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001044

Date:January 5, 2011
From:Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 1044 – Fluorochemical copolymer as an oil and grease resistant treatment employed either prior to or after the sheet forming operation for paper and paperboard.
Notifier:Daikin America, Inc.
905 State Docks Road
Decatur, AL 35601
To:Division of Food Contact Notifications (HFS-275)
Attention: Mark A Hepp, Ph.D.
Through: William H Lamont, Acting Supervisor, ERT

The food-contact substance (FCS) is 2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester, polymer with 1-ethenyl-2-pyrrolidinone, 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate, sodium salt.

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 finished food-packaging 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 the 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.

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 1044. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated May 28, 2010, may be made available to the public. We will 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.

 

Leah D Proffitt

 

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food-contact notification (FCN No. 1044), submitted by Daikin America, Inc., to provide for the safe use of 2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester, polymer with 1-ethenyl-2-pyrrolidinone, 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate, sodium salt as a grease-proofing agent for food-contact paper and paperboard at levels of up to 1.0 percent-by-weight added at either the size press or before sheet formation.

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, including an environmental assessment, dated May 28, 2010, in the notification submitted by the notifier, and other information known to the agency..

 

Prepared by __________________________________________Date: January 5, 2011
Leah D Proffitt
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: January 5, 2011
William H. Lamont, Chemist
Acting Supervisor, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration