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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. 001277

 

Date: April 11, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1277 – 2-propen-1-aminium, N, N-dimethyl-N-2-propen-1-yl-, chloride (1:1), polymer with ethanedial and 2-propenamide, asa dry- and wet-strength and dewatering agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard, at levels not to exceed 0.25 percent by weight of the dry fibers in the finished paper and paperboard.
Notifier: Nalco, an Ecolab Company
 
To: Vivian Gilliam, Division of Food Contact Notifications (HFS-275)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
 
 Attached is the Finding of No Significant Impact (FONSI) for FCN 1277. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated April 9, 2013, 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. 1277), submitted by Nalco, an Ecolab Company, to provide for the safe use of 2-propen-1-aminium, N, N-dimethyl-N-2-propen-1-yl-, chloride (1:1), polymer with ethanedial and 2-propenamide, asa dry- and wet-strength and dewatering agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard, at levels not to exceed 0.25 percent by weight of the dry fibers in the finished paper and paperboard..
 
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 April 9, 2013 as summarized below.
 
Paper processing involves substantial quantities of water, which may in turn result in the leaching or rinsing of the food contact substance (FCS) from the pulp slurry before final paper formation. Although the FCS itself is substantive to the paper, the formulation contains excess residual water-soluble monomers which are not substantive to the paper and are lost during the sheet formation process. Residual acrylamide, diallyldimethylammonium chloride (DADMAC), and glyoxal can be expected to preferentially remain in the whitewater, the waste water generated during paper and paperboard processing. The environmental component of concern is the glyoxal monomer as the subject FCS is intended to compete with and replace acrylamide and DADMAC copolymers already authorized for use in food-contact paper and paperboard. Based on the solubility and partition coefficient of glyoxal, any excess glyoxal which survives the wastewater treatment of discharged paper-mill whitewater from the paper production process is potentially emitted into the environment in the aqueous compartment. Glyoxal is not expected to partition into other environmental components to any significant degree.   The expected environmental concentration for glyoxal resulting from this notified use is orders of magnitude below the most sensitive acute toxicity endpoint for aqueous species, the algae EC50 of 149 ppm (Pseudokirchneriella subcptitata, prev. Selenastrum carpricornutum).   Therefore, no adverse impacts are expected on aqueous species.
 
Paper and paperboard containing the FCS will be disposed in accordance with standard disposal practices and would be expected to be landfilled, combusted or recycled at the same rate as similar materials. As the FCS is expected to compete with and replace currently marketed articles, no increase in use of resources or energy is expected.
 
Prepared by     __________________________________________Date: April 11, 2013
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: April 11, 2013
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