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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001236

 

December 9, 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: Kelly Randolph, DVM, MPH.
 
Subject: FCN No. 1236 – A mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidene-1,1- diphosphonic acid (HEDP), and water, as an antimicrobial agent on meat carcasses, parts, trims and organs. The FCS will be added as a spray, rinse, dip, chiller water or scald water.
 
Notifier: Ecolab, Inc.
 
 Attached is the Finding of No Significant Impact (FONSI) for FCN 1236. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated October 1, 2012, 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.
 
 
Leah D. Proffitt
 
 
 
 
 
 
 
Attachment:         Finding of No Significant Impact
 
     


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1236), 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 (HEDP), and water, as an antimicrobial agent on meat carcasses, parts, trims and organs. The FCS will be added as a spray, rinse, dip, chiller water or scald water.
 
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 October 1, 2012 as summarized below.
 
Peroxyacetic acid, hydrogen peroxide, and acetic acid degrade rapidly in contact with organic matter; therefore, the compound of environmental concern is HEDP, which is comparatively stable and is expected to persist in the environment.
 
The notifier cites a POTW daily flow rate from of 3.8 million liters per day (≈ 1mgd), of which the meat facility’s share is 475,000 L/day (≈ 125,500 mgd). The resulting EEC for HEDP is 50 ppb. This value is sufficiently below the lowest available ecotoxicity endpoint of 7.2 ppm (algae Selenestrum capricornutum) such that no adverse impact is expected.
 
 


 

 
 
Prepared by     __________________________________________Date: December 10, 2012
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: December 10, 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