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U.S. Department of Health and Human Services

Food

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Environmental Decision Memo for Food Contact Notification No. 000801

Date:February 29, 2008
From:Supervisor, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 801 - Peroxyacetic acid solution containing 1-hydroxyethylidene-1,1-diphosphonic acid for use as an antimicrobial for food-contact packaging.
Notifier:FMC Corporation
c/o Keller and Heckman, LLP
Washington, D.C., USA
To:Division of Food Contact Notifications (HFS-275)
Attention: Julius Smith


 

 

The food contact substance for this notification will be used to treat food-contact surfaces of plastic containers and their enclosures to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for in 21 C.F.R. Part 113 or as an antimicrobial on packaging for any acidic food. The peroxyacetic acid solutions will contain equilibrium concentrations of peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), and water. The average quantity of HEDP residue on food-contact surfaces of containers/enclosures immediately prior to introduction of food will not exceed 1.1 x 10-3 milligrams of HEDP per square inch of packaging surface.

Attached are the Finding of No Significant Impact (FONSI) and, by reference, our supplement to the environmental assessment (EA) for FCN 634 by the same notifier and available at http://www.cfsan.fda.gov/~rdb/opa-envt.html.* When this notification becomes effective, the FONSI and the notifier's EA, dated December 31, 2007, may be made available to the public, and we will post them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.*

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

Layla I. Batarseh, Ph.D.

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 801), submitted by FMC Corporation, to provide for the safe use of a solution containing equilibrium concentrations of peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), and water as an antimicrobial agent for food-contact surfaces of plastic containers and their enclosures.

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 the notification, including an environmental assessment, dated December 31, 2007, and our supplement to the environmental record of the notifier's effective FCN 634.

Prepared by __________________________________________Date: February 29, 2008
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.