Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1787

Recently Published Environmental Assessments and FONSIs

FINDING OF NO SIGNIFICANT IMPACT

Proposed Action: Food Contact Substance (FCS) Notification (FCN) 1787, submitted by BASF SE, for use of hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine (CAS Reg. No. 24993-04-2) as a component in multi-layer films intended to contact food. The multi-layer films containing the FCS may be used for single and repeated use in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2.^[1] The films will have a maximum thickness of 2 mil (0.002 inch) of the FCS. Adjuvant substances permitted for use in Nylon 6/66 polymers may be used in the FCS, subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation or notification. 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.

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 May 17, 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 component in multi-layer films used to make food-contact articles. Manufacture of the FCS and FCS-containing food-contact articles is not expected to result in adverse environmental impact. Once the FCS-containing food contact articles 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. Consequently, the FCS is expected to be primarily land disposed (80% of the FCS) and secondarily, incinerated (20% 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 (as disclosed in a confidential attachment to the EA), the FCS is not expected to be introduced to land or water when disposed via landfill. Similarly, 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 and the marginal amount of FCS compared to all combusted MSW). The EA also considered the impact of greenhouse gas (GHG) emissions in a confidential attachment. According to information in a confidential attachment to the EA, total annual emissions of GHGs represented as carbon dioxide-equivalents (CO2-e) in metric tons (mT), are well below the 25,000 mT GHG reporting threshold described in 40 CFR 98.2. Therefore, no significant impacts are expected from incineration of the FCS at MSW combustion facilities. In sum, we do not expect a significant impact to the environment from the use of the FCS as specified in FCN 1787.

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 1787, as a component in multi-layer films used to make food-contact articles, will not significantly affect the quality of the human environment; therefore, an EIS will not be prepared.

Prepared by __________________________________________Date: digitally signed 06-27-2017
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 06-27-2017
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] https://www.fda.gov/food/ingredientspackaginglabeling/packagingfcs/foodtypesconditionsofuse/default.htm, accessed 5/25/17

U.S. Food and Drug Administration
Revision Sheet for the May 17, 2017 EA for FCN 1787

Dated: June 27, 2017

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of May 17, 2017 for food contact notification (FCN) 1787 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 following:

Footnote 1 contradicts the text of the EA (the text is correct). Footnote 1 states "[t]he percent noted above are based on municipal solid waste, excluding waste recovered for composting," when it should use the word including instead of "excluding" (bolded emphasis added to draw attention to typographical error). The 34.6% of municipal solid waste (MSW) refers to the percent MSW recycled and composted in the U.S. in 2014.
Footnote 4 indicates one of the authors is "Swoboda," when in fact the correct spelling is Svoboda (bolded emphasis added to draw attention to the typographical error).
Under Item 6 b of the EA (right before Item 7) the EA discusses "lines" instead of "liners." This is a typographical error, as liners are used in U.S. landfills to prevent leaching.

FINDING OF NO SIGNIFICANT IMPACT

U.S. Food and Drug Administration Revision Sheet for the May 17, 2017 EA for FCN 1787

U.S. Food and Drug Administration
Revision Sheet for the May 17, 2017 EA for FCN 1787