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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001285

 

Date: May 21, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN 1285- 2-propen-1-aminium, N, N-dimethyl-N-2-propen-1-yl-, chloride (1:1), polymer with the ethanedial and 2-propenamide (CAS. Reg. No. 32555-39-8) for use as a dry- and wet- strength agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard at concentrations not to exceed 1.0% by wt. of the dry fibers in the finished paper and paperboard, which may contact all food types under Conditions of Use E through H.
Notifier: BASF Corporation
 
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 1285. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated May 10, 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.
 
 
Talia A. Lindheimer
 
 
 
 
 
 
 
Attachment:         Finding of No Significant Impact
 
cc:       HFS-255 Lindheimer
File:    FCN No. 1285


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1285), submitted by BASF Corporation, to provide for the safe use of 2-propen-1-aminium, N, N-dimethyl-N-2-propen-1-yl-, chloride (1:1), polymer with the ethanedial and 2-propenamide (CAS. Reg. No. 32555-39-8) for use as a dry- and wet- strength agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard at concentrations not to exceed 1.0% by wt. of the dry fibers in the finished paper and paperboard, which may contact all food types under Conditions of Use E through H.
 
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 (EA), dated May 10, 2013, as summarized below.
 
The Food Contact Substance (FCS) will be used be used as a dry- and wet- strength agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard at concentrations not to exceed 1.0% by wt. of the dry fibers in the finished paper and paperboard. Disposal of paper articles, which contain the FCS, is expected to be via landfilling and incineration. When paper products are properly disposed into landfills operating in compliance with EPA regulations in 40 CFR Part 258 with mandated operating systems, no significant releases of the FCS to the environment is expected. The incineration of the food contact articles containing the FCS is expected to result in a release of carbon dioxide, water, and nitrogen oxides. Based on the low level of the FCS that is expected to be present in the paper, it is reasonably expected that the disposal via incineration will not significantly alter emissions from municipal solid waste combustors or threaten a violation of 40 CFR Part 60. In the unlikely event that the FCS does enter the wastewater stream during paper processing, any residues that do not biodegrade will show a tendency to absorb to solids in the wastewater and settle as sludge. These solid wastes will also be disposed of by landfilling or incineration. 
 
The potential for environmental impact is predominantly from release of these monomers to the aqueous environment, specifically the excess glyoxal polymer cross-linking agent and to a lesser extent, acrylamide and DADMAC. As the FCS is added to the whitewater at the wet-end of paper processing, the unpolymerized (residual) monomers in the FCS formulation are expected to be lost to the environment as they are not substantive to the paper. The exact percentage of the formulation comprised of residual monomers is confidential business information included in a confidential attachment to the EA. While these numbers cannot be publicly disclosed, the general practice is that they monomers comprise not more than 30% by weight of the FCS.
 
Environmental introduction concentrations (EICs), and estimated environmental concentrations (EECs) for each of the three monomers, when applied at the maximum usage rate were calculated in a confidential attachment to the EA. These calculations assume approximately 98% of the monomers are lost with the whitewater, a daily production capacity of 750,000 kg/paper/day and the maximum application rate of 1.0%. However, these calculations include two errors; specifically that they assume an average value for the fraction of the monomer in the FCS formulation, and that they apply a 1000-fold dilution factor to the EICs when calculating the EECs. 
 
The EICs and EECs were recalculated using the maximum residual level of the specific monomers as found in the FCS and a more conservative dilution factor of 10. As the EICs and EECs factor in the individual weight fraction of each monomer of interest (glyoxal, DADMAC, or acrylamide), they are protected from disclosure under 18 U.S.C. 1905 and 21 U.S.C. 331(j).   However, the revised EICs are well below 0.5ppm.   The corrected EECs for the residual monomers entering the environment through process whitewater are sufficiently below aquatic ecotoxicity endpoints, such any release of the FCS into the environment are not expected to have any adverse effect on the organisms present in the aquatic environment.    
 

Ecotoxicity Values
Monomer
Most sensitive LC50
Glyoxal
134 ppm, 16-hr EC50 Pseudomonas putidaa
Acrylamide
78 ppm, 96-hr LC50 mysid shrimpb
DADMAC
33.3 ppm, 96-hr LC50 blue-green algaec

 
a: OECD 2003. OECD SIDS Document for Glyoxal (CAS No. 107-22-2). UNEP Publications.
b: USEPA, 2013. Summary of Chemical Testing and Data. http://www.epa.gov/oppt/chemtest/
c: USEPA, 2003. DADMAC HPV Challenge Task Group. 10/27/2003. http://www.epa.gov/hpv/pubs/summaries/dialdime/c15208rs.pdf
 
The FCS is intended to compete with, and to some degree replace materials currently utilized in the paper industries. Therefore, no increase in use of resources or energy is expected.
 
No significant environmental impacts have been identified as a result of the use and post-consumer disposal of the FCS, which would otherwise require the preparation of an environmental impact statement.
 
 


 

Prepared by     __________________________________________Date: May 21, 2013
Talia A. Lindheimer
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by   __________________________________________Date: May 21, 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