Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1733

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) 1733, submitted by LANXESS Corporation, for use of 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) as: (1) a preservative in aqueous formulations of adhesives that will be used under use conditions defined in 21 CFR 175.105; (2) a preservative in aqueous coating formulations to be used on paper under use conditions defined in 21 CFR 176.170; (3) a preservative in aqueous additive formulations (latex emulsions, fillers, binders, pigment slurries, and sizing solutions) used in paper and paperboard manufacturing to produce paper in compliance with 21 CFR 176.170 and 176.180; and (4) as a slimicide in the wet end of paper manufacturing to produce paper in compliance with 21 CFR 176.170 and 176.180. The FCS may be used in contact with all food types under Conditions of Use A through H, as described in Table 2.^[1] The maximum level of the FCS: (1) in adhesives is 150 ppm; (2) in paper coating formulations is 150 ppm, with the exception of latex coatings where the maximum level is 250 ppm; (3) in aqueous additive formulations for use in paper is 150 ppm (4) as a slimicide used in the wet end of paper manufacture is 150 ppm in the process water. The FCS is not for use in contact with infant formula or 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 March 8, 2017 and a confidential attachment to the EA dated March 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 as a preservative in aqueous adhesive, coating and additive formulations; as well as a slimicide in the wet end of paper manufacturing. The EA explains the uses established per FCN 1733 are intended for the manufacture of food-contact paper and paperboard. 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 significant environmental impact. Manufacture of food-contact articles containing the FCS is also not expected to result in a significant impact to the environment. Furthermore, manufacture of food-contact articles per FCN 1733 will happen outside of the United States, under the jurisdiction of a foreign nation (and not in the global commons); therefore an assessment of the environmental impact related to the manufacture of food-contact articles per FCN 1733 is outside the scope of the EA. Once the finished food-contact articles per FCN 1733 are made, they will be used and disposed of in the United States; consequently, the EA does consider the potential environmental impact from use and disposal of the finished food-contact articles.

The food-contact articles manufactured per FCN 1733 are expected to be recycled and discarded in the trash (trash discards will either reach a landfill or a municipal solid waste, MSW, combustion facility). As antimicrobial agents are typical components of paper and paperboard food-contact articles, no impact is expected on recycling. 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 Part 60, the regulations governing MSW combustion facilities. This analysis is 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 resulting from combustion of articles manufactured with the FCS and provided an analysis in the 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 environmental 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 1733.

As indicated in the EA, we do not expect a net increase in the use of energy and resources from the notified 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 1733, as a preservative in aqueous adhesive, coating and additive formulations; as well as a slimicide in the wet end of paper manufacturing of 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 06-09-2017
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 06-09-2017
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] Food Types & Conditions of Use for Food Contact Substances, accessed 6/5/17

U.S. Food and Drug Administration
Revision Sheet for the March 8, 2017 EA for FCN 1733

Dated: June 9, 2017

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of March 8, 2017 for Food Contact Substance (FCS) Notification (FCN) 1733 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:

Page 2 of the EA indicates that the IUPAC^[1] nomenclature for the FCS is "2-methyl-2H-isothiazolin-3-one," when in fact the IUPAC nomenclature is "2-methyl-1,2-thiazol-3-one."^[2] The reader should disregard this error.
Page 4 of the EA asks the reader to look "above" for Table 1, however, Table 1 is below. Consequently, the reader should disregard the direction to look above, and look below for Table 1.

Despite these inaccurate statements, the EA demonstrates no significant impact on the environment.

[1] IUPAC stands for the International Union of Pure and Applied Chemistry

[2] https://pubchem.ncbi.nlm.nih.gov/compound/2-Methyl-4-isothiazolin-3-one#section=Names-and-Identifiers, accessed 6/9/17

FINDING OF NO SIGNIFICANT IMPACT

U.S. Food and Drug Administration Revision Sheet for the March 8, 2017 EA for FCN 1733

U.S. Food and Drug Administration
Revision Sheet for the March 8, 2017 EA for FCN 1733