Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1716

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) 1716, submitted by Avery Dennison Corporation, for use of a polymer of butyl acrylate and 4-hydroxybutyl acrylate, with a methylene diphenyl diisocyanate-based crosslinker as an adhesive for reclosure labels used with packaging.

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 October 26, 2016. 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 an adhesive for reclosure labels used with packaging, and allows for the consumer to reseal the package after opening. The FCS may be used at a coat weight of up to 23 g/m2 in contact with all food types under Condition of Use C through H. 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 substance in the FCN.

Manufacture of the FCS is not expected to result in adverse environmental impact. Once the food contact articles with the reclosure labels are made, they will be used and disposed of by conventional rubbish disposal. The food contact articles in which the FCS will be used are not expected to be recycled to any significant extent. Consequently, the FCS is expected to be primarily land disposed (80.4% of the FCS) and secondarily, incinerated (19.6% of the FCS) based on disposal trends for municipal solid waste (MSW), as reported by the U.S. Environmental Protection Agency (EPA). Based on confidential market volume information provided in a confidential attachment to the EA, the FCS will make up a very small portion of the total MSW landfilled and incinerated.

Because of EPA’s regulations governing landfills (40 CFR Part 258) and the marginal amount of the FCS that would be landfilled only very small amounts (if any) of the FCS is expected to be introduced to land, and to an even lesser extent water. Similarly, because of the composition of the FCS and the low market volume of the FCS, it is not anticipated that combustion of the FCS would threaten a violation of EPA regulations governing MSW combustion facilities (40 CFR Part 60). The EA also considered the impact of greenhouse gas (GHG) emissions in a confidential attachment. The GHGs carbon dioxide and nitrous oxide are anticipated to be released upon combustion of the FCS. The Council on Environmental Quality (CEQ) in their final guidance on GHG emissions and climate change impacts directs agencies to “ensure their analysis of potential GHG emissions and effect of climate change in an EA or EIS is commensurate with the extent of the proposed action.” 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 the information provided in the confidential attachment to the EA, total estimated GHG emissions resulting from the use of the FCS per FCN 1716 is below 25,000 metric tons carbon dioxide equivalents (CO2-e). In sum, we do not expect a significant impact to the environment from the use of the FCS as specified in FCN 1716.

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 1716, as an adhesive for reclosure labels used with packaging, will not significantly affect the quality of the human environment; therefore, an EIS will not be prepared.

Prepared by __________________________________________Date: digitally signed 02-13-2017
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 02-15-2017
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition Food and Drug Administration

U.S. Food and Drug Administration
Revision Sheet for the October 26, 2016 EA for FCN 1716

Dated: February 13, 2017

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of October 26, 2016 for food contact notification (FCN) 1716 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 explain the discrepancy in use rates in the EA versus the regulatory language and to correct an inaccurate statement in the EA:

The use rate is discussed on page 15-2 under Item 4 of the EA: “for use as an adhesive at a coat weight of 21 g/m2 in reclosure labels for packaged food…” This use rate is different than the use rate discussed in the limitations/specifications of the regulatory language: “for use at a coat weight up to 23 g/m2 in contact with all food types under…” This discrepancy has no bearing on our analysis because:
1. The regulatory language does not preclude a use rate of 21 g/m2, and
2. The difference in use rates does not change our conclusions and FONSI.
The inaccurate statement is on page 15-4 under Item 6 of the EA: “Accordingly, the disposal of the FCS does not threaten a violation of 40 C.F.R. Part 60 because the regulations at 40 C.F.R. Part 258 prevent leaching of the FCS from sanitary landfills.” This statement is confusing and inaccurate because a violation under 40 CFR Part 60 is not related to regulations at 40 CFR Part 258, as regulations at 40 CFR Part 60 are in regards to air and regulations at 40 CFR Part 258 are in regards to landfills. However, despite this inaccurate statement, the EA clearly demonstrates no significant impact on the environment, and the statement is clarified in the FONSI:

“Because of EPA’s regulations governing landfills (40 CFR Part 258) and the marginal amount of the FCS that would be landfilled only very small amounts of the FCS is expected to be introduced to land, and to an even lesser extent water. Similarly, because of the composition of the FCS and the low market volume of the FCS, it is not anticipated that combustion of the FCS would threaten a violation of EPA regulations governing MSW combustion facilities (40 CFR Part 60).”

FINDING OF NO SIGNIFICANT IMPACT

U.S. Food and Drug Administration Revision Sheet for the October 26, 2016 EA for FCN 1716

U.S. Food and Drug Administration
Revision Sheet for the October 26, 2016 EA for FCN 1716