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Date: July 11, 2017
From: Biologist, Acting Environmental Review Team, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject: Finding of No Significant Impact for Food Contact Notification 1756 Ethanol, 2-amino- (CAS Reg. No. 141-43-5)
Notifier: Omya International AG and its Affiliates
To: Vanee Komolprasert, Ph.D., Consumer Safety Officer, Division of Food Contact Notifications (HFS-275)
Attached is the Finding of No Significant Impact (FONSI) for Food Contact substance Notification (FCN) 1756, which is for the use of Ethanol, 2-amino- (CAS Reg. No. 141-43-5), MEA, as a component of fillers or coatings for paper and paperboard, except for use in contact with infant formula and human milk.
After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated April 7, 2017, 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.
Attachments: Finding of No Significant Impact and EA Revision Sheet
FINDING OF NO SIGNIFICANT IMPACT
Proposed Action: Food Contact Substance (FCS) Notification (FCN) 1756, submitted by Omya International AG and its Affiliates, for use of Ethanol, 2-amino- (CAS Reg. No. 141-43-5) , MEA, as a component of fillers or coatings for paper and paperboard, except for use in contact with infant formula and human milk. The FCS may be used a maximum rate in the finished paper of 0.041 wt-% for filler applications and 0.01 wt-% for coating applications. Finished materials and articles containing the FCS may be used in single use applications, for contact with all types of food, under FDA Conditions of Use E through G. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the FCS in the FCN.
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, an environmental impact statement (EIS) will not be prepared. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated April 7, 2017. The EA was prepared in accordance with 21 CFR 25.40. The EA is incorporated by reference in this Finding of No Significant Impact (FONSI), and is briefly summarized below.
The FCS is intended for use as a dispersion and flotation agent for calcium carbonate that is in turn used as a filler and coating during the paper manufacturing process. The processing benefit provided by the FCS results in increased dispersion of the calcium carbonate filler added to food contact paper which in turn acts to increase brightness and opacity.
Manufacture of the FCS is not expected to result in significant environmental impact. Manufacture of food-contact articles containing the FCS is also not expected to result in a significant impact to the environment. When the FCS is used in coatings on food-contact articles, the process is a dry-end application, and all of the FCS remains with the coating, and all of the coating remains on the food-contact article. Therefore, finished paper and paperboard containing the FCS will be recycled or disposed of via municipal solid waste (MSW) disposal into landfills or to MSW combustors. On the other hand, when the FCS is used as a filler, the process is a wet-end application, and because the FCS is highly soluble in water is expected to be lost with the white water associated with paper making. The FCS is not expected to significantly adsorb to sewage sludge as demonstrated by the low Kow partition coefficient.
During the wet-end papermaking process, the FCS is expected to partition into and remain with the processing whitewater. Following an approximate 95% biodegradation during wastewater treatment and a 10-fold dilution into surface water the estimated environmental concentration (EEC) is 0.5 ppm. This value is approximately three-fold lower than the 1.24 ppm NOEC (No Observed Effects Concentration) reproductive toxicity endpoint for the most sensitive species (Japanese killifish).
As noted above, when the FCS is used in coatings for paper and paperboard, the anticipated routes of disposal after use are expected to be recycling, landfilling or combustion in MSW incinerators. The FCS is not expected to impact recyclability as calcium carbonate coated paper is typical in the recycling stream, and the FCS will be less than 0.1% of the final food-contact article. When landfilled, the EA explains no environmental introduction is expected per 40 CFR 258, the regulations governing landfills. When combusted, the EA explains there is nothing to suggest the FCS would threaten a violation of 40 CFR 60, the regulations governing MSW combustion facilities (based on the composition of the FCS).
The EA also considered the impact of greenhouse gas (GHG) emissions. The GHGs carbon dioxide and nitrous oxide may be released upon combustion of the FCS. MSW combustion facilities that emit 25,000 metric tons carbon dioxide equivalents (CO2-e) or more per year are required to report their GHG emissions per the Environmental Protection Agency’s Greenhouse Gas Reporting Program (EPA GHGRP). If an FCN was expected to contribute such a level of GHG, more analysis would be necessary to determine if it constituted a significant environmental impact. However, based on estimated market volume information provided in a confidential attachment to the EA, the total estimated GHG emissions resulting from the combustion of the FCS per FCN 1756, is below 25,000 metric tons CO2-e. Therefore, significant impacts to the environment from the use of the FCS as specified in FCN 1756 are not anticipated.
As indicated in the EA, we do not expect a net increase in the use of energy and resources from the use of the FCS, nor do we expect adverse environmental effects, which would necessitate alternative actions to that proposed in this FCN. The alternative of not approving the action proposed herein would result in the continued use of the materials which the FCS would otherwise replace; such action would have no environmental impact. Furthermore, as the use and disposal of the FCS is not expected to result in significant adverse environmental impacts; mitigation measures are not identified.
As evaluated in the EA, the use of the FCS, as described in FCN 1756, as a dispersion and flotation agent for calcium carbonate fillers and coatings for use in paper and paperboard food-contact materials, will not significantly affect the quality of the human environment; therefore, an EIS will not be prepared.
Prepared by __________________________________________Date: digitally signed 07-11-2017
Biologist / Acting Lead, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration