• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

Environmental Decision Memo for Food Contact Notification No. 1027

Date:December 6, 2010
From:Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 1027 – Fluorochemical copolymer as an oil and grease resistant treatment employed either prior to or after the sheet forming operation for paper and paperboard.
Notifier:DuPont Chemicals and Fluoroproducts
E402/4313A – PO Box 80402
Wilmington, DE 19880
To:Division of Food Contact Notifications (HFS-275)
Attention: Vanee Komolprasert, Ph.D., P.E.
Through: William H Lamont, Acting Supervisor, ERT

This memorandum and the attached Finding of No Significant Impact supersede those issued on November 18, 2010. Since that date, a determination was made that the name of the substance, provided originally in the agency's acknowledgment letter, dated October 8, 2010, to the notifier, does not include the "ammonium" moiety. The change in the identity of the food-contact substance (FCS) is editorial only and does not affect the basis of the environmental considerations used for the final environmental decision.

The FCS is 2-propenoic acid, 2-methyl-, polymer with 2-(diethylamino)ethyl 2-methyl-2-propenoate, 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-methyl-2-propenoate, acetate.

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 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 1027. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated September 9, 2010, 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.

 

Hoshing W. Chang

 

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 1027), submitted by DuPont Chemicals and Fluoroproducts, to provide for the safe use of 2-propenoic acid, 2-methyl-, polymer with 2-(diethylamino)ethyl 2-methyl-2-propenoate, 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-methyl-2-propenoate, acetate as an oil and grease resistant treatment for paper and paperboard employed either prior to or after the sheet forming operation.

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 September 9, 2010, and other information known to the agency.

 

Prepared by __________________________________________Date: December 6, 2010
Hoshing W Chang, Ph.D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: December 6, 2010
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