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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. 001096

Date:May 25, 2011
From:Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Office of Food Additive Safety (HFS-255)
Subject:FCN No. 1096– Peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidene-1,1- diphosphonic acid, and water with 12-aminododecanoic acid, hexahydro-2H-azepin-2-one, and 1,6-hexanediamine.
Notifier:Ecolab Inc.
370 Wabash St., N., EUC-9
St. Paul, MN 55102
To:Division of Food Contact Notifications (HFS-275)
Attention: Thomas C. Zebovitz, Ph.D.
Through: Annette M McCarthy, PhD, Lead Environmental Review Scientist

The FCS is for use as an antimicrobial agent to process poultry carcasses, parts, and organs following slaughter. It can be applied as a spray, wash, rinse, dip, chiller water, or scald.

Attached is the Finding of No Significant Impact (FONSI) for FCN 1096. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated April 18, 2011, 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.

 

Hoshing W. Chang, Ph.D.

 

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food-contact notification (FCN No. 1096), submitted by Ecolab, Inc., to provide for the safe use of a mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidene-1,1- diphosphonic acid, and water with 12-aminododecanoic acid, hexahydro-2H-azepin-2-one, and 1,6-hexanediamine as an antimicrobial agent to process poultry carcasses, parts, and organs following slaughter. It can be applied as a spray, wash, rinse, dip, chiller water, or scald.

The Office of Food Additive Safety 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 April 18, 2011, in the notification submitted by the notifier, and other information known to the agency.

 

Prepared by __________________________________________Date: May 25, 2011
Hoshing W. Chang, Ph.D.
Regulatory Team 2
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: May 25, 2011
Annette M. McCarthy, Ph.D.
Lead Environmental Review Scientist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration