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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000911

Date:July 13, 2009
From:Acting Supervisor, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 911 - Antimicrobial composition for commercial sterilization of poly(ethylene terephthalate) bottles and polypropylene closures fitted with polystyrene liners prior to their use.
Notifier:Ecolab, Inc.
370 North Wabasha Street
St. Paul, MN 55102
 
To:Division of Food Contact Notifications (HFS-275)
Attention: Mark A Hepp, Ph.D.
 

Attached is the Finding of No Significant Impact (FONSI) for FCN 911. The food contact substance is an aqueous solution of 1-hydroxyethylidine-1,1-diphosphonic acid and peroxyacetic acid that is in equilibrium with acetic acid and hydrogen peroxide and an optional adjuvant mixture of dibasic esters that comprises dimethyl sebacate (up to 20 percent by weight), dimethyl succinate (up to 0.8 percent by weight), dimethyl adipate (68-76 percent by weight), and dimethyl glutarate (4-12 percent by weight). After this notification becomes effective, this FONSI and the notifier's environmental assessment, dated June 3, 2009, may be made available to the public, and we will post them on the internet where they can be accessed from the agency's 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. 911), submitted by Ecolab, Inc., to provide for the safe use of a composition containing an aqueous solution and an optional adjuvant mixture. The solution contains 1-hydroxyethylidene-1,1-diphosphonic acid and peroxyacetic acid that is in equilibrium with acetic acid and hydrogen peroxide. The optional adjuvant mixture comprises butanedioic acid (dimethyl succinate), up to 0.8 percent; pentanedioic acid (dimethyl glutarate), 4 - 12 percent; hexanedioic acid (dimethyl adipate), 68 - 76 percent; and decanedioic acid (dimethyl sebacate), up to 20 percent. The composition in intended for sterilizing poly(ethylene terephthalate) bottles and polypropylene closures fitted with polystyrene liners prior to their use.

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 June 3, 2009, submitted by the notifier and other information known to the agency.

 

Prepared by __________________________________________Date: July 13, 2009
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