Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1742

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or the Inventory of Effective Food Contact Substance Notifications.

FINDING OF NO SIGNIFICANT IMPACT

Proposed Action: Food Contact Substance (FCS) Notification (FCN) 1742, submitted by Bulk Chemical Services, LLC, for use of 2-propenoic acid, homopolymer, sodium salt (CAS Reg. No. 9003-04-7) as a mineral pigment dispersant for calcium carbonate or kaolin pigments in the manufacture of food-contact paper and paperboard in contact with all food types. The FCS may be used in coatings at a level not to exceed 1.25 weight percent of solid pigment and in mineral fillers at a level not to exceed 0.6 weight percent of solid pigment. 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.

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. On the other hand, when the FCS is used with mineral fillers, the process is a wet-end application, and FCS will be lost with the white water associated with paper making, and ultimately may reach the environment via water and land applied sludge. During the wet-end papermaking process, the paper slurry contains at most 2% solids. Of that 2%, mineral filler is expected to comprise about 10% of these solids, and per the specifications of FCN 1742, 0.6% of the mineral filler will be the FCS (resulting in a maximum concentration of the FCS 0.0012% or 12 parts per million, ppm in the paper slurry). Most of the FCS (about 80%) is expected to remain with the solids, and become a part of the paper food-contact material; whereas at most 20% may remain with the water, and become a component of the wastewater at a maximum concentration of 2.4 ppm (20% of 12 ppm). The environmental introduction concentration of 2.4 ppm is used as a worse case in water and in sludge (since dilution, further partitioning in wastewater treatment facilities and biodegradation are likely to decrease this concentration).

Although the EA identifies a chronic aquatic ecotoxicity endpoint lower than 2.4 ppm (a No Observed Effects Concentration, NOEC in daphnia), the EA explains the toxicity observed is an artifact of test conditions, not of the FCS: when the test solution was filtered to remove precipitants, no toxicity was observed at any of the test concentrations. The next lowest chronic aquatic toxicity endpoint was 6 mg/liter, a NOEC from a reproduction study with daphnia, which is about two-fold higher than estimated environmental introduction concentration of 2.4 ppm. The lowest acute aquatic ecotoxicity endpoint at which effects were estimated is an EC10^[1] for algae at 32 mg/liter, which is over ten-fold higher than the aquatic environmental introduction concentration of 2.4 ppm. Similarly, the EA identifies terrestrial endpoints in plants (225 mg/kg NOEC in corn, wheat and soybean) and earthworms (1,000 mg/kg NOEC) that are about 100-fold and 400-fold higher than the terrestrial environmental introduction concentration of 2.4 ppm.

Once the food contact articles are made, they will be used and disposed of in conventional ways. The food contact articles in which the FCS will be used are expected to be recycled, landfilled or combusted after use. The FCS is not expected to impact recyclability (as pigmented paper, with dispersed pigment, is typical in the recycling stream, and the FCS will be less than 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 GHG carbon dioxide 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, the total estimated GHG emissions resulting from the combustion of the FCS per FCN 1742, is below 25,000 metric tons CO2-e. In sum, we do not expect a significant impact to the environment from the use of the FCS as specified in FCN 1742.

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 1742, as a pigment dispersant 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 06-05-2017
Sarah C. Winfield
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 06-05-2017
Mariellen Pfeil
Biologist / Acting Lead, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

[1] The concentration that causes the measured effect in 10% of the tested organisms

U.S. Food and Drug Administration
Revision Sheet for the February 14, 2017 EA for FCN 1742

Dated: June 5, 2017

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of February 14, 2017 for food contact notification (FCN) 1742 concluded that the action will not constitute a significant impact. The revision is issued to make a minor change and update of an editorial nature that should be acknowledged, while not making any substantive changes to the EA. This revision does not impact our Finding of No Significant Impact (FONSI).

The revision is necessary to correct the following in the EA:

On page 1 the EA states “the use in mineral fillers will result in higher levels of the FCS in both the final food-contact article and in wastewater as compared to the use in coatings.” (emphasis added). In fact, the use in mineral fillers will result in a lower level (0.06%) of the food contact substance (FCS) in the final food-contact article, i.e., finished paper, compared to the use in coatings (0.38%). However, only the mineral filler use results in environmental introductions of the FCS, so this use results in higher environmental introduction levels of the FCS. As the discussion in the EA provides an adequate analysis of the environmental introductions resulting from both notified uses of the FCS this statement is unnecessary. Therefore, the reader should disregard the sentence, “Because the use in mineral fillers will result in higher levels of the FCS in both the final food-contact article and in wastewater as compared to the use in coatings, this environmental assessment will focus on the potential environmental impact resulting from the use in mineral fillers.”
Item 8 of the EA (on page 7) states that at a paper mill’s on-site sewage treatment plant, the outflow concentration is “40 ppb (see Item 6b), i.e. < 0.04 mg*L^-1” with a margin of safety of “greater than 150x.” Additionally, this section of the EA states that the “concentration of sludge-amended soils can be estimated to be 0.6 mg*kg^-1 soil at the time of application (see Item 6c).” These are apparent editing errors as the sewage treatment outflow concentration and worst-case land-applied sludge concentrations are calculated in Item 6b as 2.4 ppm, and there is no Item 6c in the EA. Since Item 6 of the EA provides an adequate analysis of the FCS environmental introduction concentrations and compares these to relevant endpoints, the reader should disregard Item 8 of the EA, and focus on the analysis provided in Item 6 of the EA.
On page 9 of the EA the reference title for reference number 10 includes the year 2013, when in fact the year in the associated hyperlink is 2014. This reference also cites ‘Fact Sheet’ when in fact the hyperlinked document is the ‘Tables and Figures’ report for the same US EPA data.

Despite these inaccurate and/or unsupported statements, the EA demonstrates no significant impact on the environment.

FINDING OF NO SIGNIFICANT IMPACT

U.S. Food and Drug Administration Revision Sheet for the February 14, 2017 EA for FCN 1742

U.S. Food and Drug Administration
Revision Sheet for the February 14, 2017 EA for FCN 1742