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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001276

 

Date: May 20, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN 1276 - 2-butenedioic (Z)-, ammonium salt, homopolymer, hydrolyzed, sodium salts (CAS Reg. No. 181828-06-8) as a dispersant for fillers in paper and paper board, not to exceed 0.5% of the dry weight of the pulp as measured at the wet end of the process.
Notifier: NanoChem Solutions Inc.
 
To: Anita Chang, Ph.D, 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 1276. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated May 8, 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. 1276


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1276), submitted by NanoChem Solutions Inc., to provide for the safe use of 2-butenedioic (Z)-, ammonium salt, homopolymer, hydrolyzed, sodium salts (CAS Reg. No. 181828-06-8) as a dispersant for fillers in paper and paper board, not to exceed 0.5% of the dry weight of the pulp as measured at the wet end of the process.
 
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 8, 2013, as summarized below.
 
The Food Contact Substance (FCS) will be used be used as a dispersant for fillers in paper and paperboard at a rate not to exceed 0.5% of the dry weight of the pulp as measured at the wet end of the process. When paper products are properly disposed into landfills with mandated operating systems, this is not expected to result in significant releases of the FCS to the environment. This is because we expect that landfills will be operating in compliance with EPA regulations in 40 CFR Part 258 governing landfills and no significant migration of the FCS would be expected. Furthermore, while we do not have market production volume information, the low level of the FCS expected to be present in the paper indicates it is reasonably expected that the disposal of the FCS via incineration will not significantly alter emissions from municipal solid waste combustors or threaten a violation of 40 CFR Part 60.
 
The log Pow less than zero[1] indicates that the FCS is not substantive to the paper. The environmental exposures to the FCS were calculated assuming that that at least 98% of the FCS will be expected to remain in the whitewater and be discharged to the environment.  Furthermore, the FCS is not expected to partition to any meaningful degree into solid waste or sludge during wastewater treatment, such that it is unlikely to be introduced to the terrestrial environment. Therefore, the aqueous environment is the primary environmental compartment of concern.
 
When estimating the daily amount of the FCS used at a paper processing facility, it is conservatively assumed that a typical paper processing plant is estimated to produce 969 metric tons (969,000 kg) of paper and paperboard daily[2].   The EA incorrectly assumes an application rate of 0.05% FCS by weight of the paper, and calculates an overall value of 484.5 kg FCS/day. Based on the 0.5% application rate of the FCS, the correct value should be 4845 kg FCS/day[3], with 4748.1 kg FCS (98%) expected to remain with whitewater, and the remaining 96.9 kg (2%) to remain with paper.
 
The Environmental Introduction Concentration (EIC) of 25 mg/L reported in the EA is representative of a large scale paper production facility. This was determined as a result of back calculations which indicated the EA utilized a daily wastewater production value of approximately 200 million gallons[4]. If a standard wastewater production value of 99 million gallons per day is used, the EIC is estimated at 50 mg/L. Assuming that the entire amount of the FCS that is applied to the paper will be present in the whitewater, and using a minimum dilution factor of 10, the Expected Environmental Concentration (EEC) is estimated to be 2.5 to 5 ppm, depending on whether the large scale facility values or average EICs are used. Regardless of the EEC that is used, available ecotoxicity data for aquatic species and support that any release of the FCS into the environment are not expected to have any adverse effect on the organisms present in the aquatic environment.  
 
The FCS is intended to be used as a substitute for the materials currently utilized in the paper industries. Furthermore, the biodegradability of the FCS suggests that no additional energy will be needed for the disposal of the FCS containing articles. 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 20, 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 20, 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


[1] Appendix 7: Bioaccumulation Test Results using HPLC for the substance A-5D, AnalyCen Exotox As, as prepared for Donlar BioPolymers, Inc. January 2001.
[3] FCS/day = (0.5% FCS by weight of paper)(969,000 kg paper)
[4] [(4845kg FCS/day)(1kg/E+9mg)]/25mg/L wastewater = 1.93E+08 L wastewater daily