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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. 001158

 

February 15, 2012
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
To: Division of Food Contact Notifications (HFS-275)
Attention: Paul Honigfort, Ph.D.
 
Subject: FCN No. 1158 – Chlorine dioxide as an antimicrobial agent for use on processed, comminuted, or formed meat food products (unless precluded by the standards of 9 CFR 319) prior to packaging of food for commercial purposes.
 
Notifier: CDG Environmental, LLC.
 
The FCS is intended for use as an antimicrobial agent in water used in poultry processing, as a spray or a dip in the processing of red meat, red meat parts and organs, on processed, comminuted, or formed meat food products (unless precluded by the standards of 9 CFR 319) prior to packaging of food for commercial purposes, on raw agricultural commodities in the preparing, packaging or holding of food for commercial purposes followed by a potable water rinse or blanching, and in water and ice that are used to rinse, wash, thaw, transport or store seafood in an amount not to exceed 3 ppm residual chlorine dioxide, as determined by Method 4500-CLO2_E in the latest edition of Standard Methods, or an equivalent method.
 
 Attached is the Finding of No Significant Impact (FONSI) for FCN 1158. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated November 14, 2011, may be made available to the public. Although the EA was for all uses cited above, only the formed meat application was reviewed for purposes of this FONSI, as the other uses had been examined in previous submissions by this notifier and are not the subject of the above referenced FCN. 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. 1158), submitted by CDG Environmental, LLC., to provide for the safe use of chlorine dioxide on processed, comminuted, or formed meat food products (unless precluded by the standards of 9 CFR 319) prior to packaging of food for commercial purposes.
 
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 submitted by the notifier in an environmental assessment, dated November 14, 2011.
 
Prepared by     __________________________________________Date: February 22, 2012
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: February 22, 2012
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration