Environmental Decision Memo for Food Contact Notification No. 1649 and EA Revision Sheet
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See also Environmental Decisions.
Date: July 21, 2016
From: Biologist, Environmental Review Team, Division of Biotechnology and GRAS Notice Review, HFS-255
Subject: Finding of No Significant Impact for Food Contact Notification 1649 (2-methyl-4-isothiazolin-3-one; CAS Reg. No. 2682-20-4)
Notifier: Lanxess Corporation
To: Thomas Zebovitz, Ph.D., Consumer Safety Officer, Division of Food Contact Notifications, HFS-275
Through: Suzanne Hill, Environmental Supervisor, Office of Food Additive Safety, HFS-255
Attached is the Finding of No Significant Impact (FONSI) for Food Contact Notification 1649, which is for the use of 2‐methyl‐2H‐isothiazol‐3‐one (MIT) antimicrobial preservative as a component in the manufacturing of food contact articles.
After this notification becomes effective, copies of this FONSI, revision sheet, and the notifier's environmental assessment, dated April 29, 2016, may be made available to the public. We will post digital transcriptions of the FONSI, revision sheet, 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.
Sarah C. Winfield
Attachments:
Finding of No Significant Impact
EA Revision Sheet
FINDING OF NO SIGNIFICANT IMPACT
Proposed Action: Food-contact notification (FCN) No. 1649, submitted by Lanxess Corporation, for use of the food contact substance (FCS) 2-methyl-4-isothiazolin-3-one (CAS No. 2682-20-4) as a preservative in: (1) coatings that comply with 21 CFR 175.300 (Resinous and polymeric coatings) and 175.320 (Resinous and polymeric coatings for polyolefin films) and (2) can-end and side-seam cements that comply with 21 CFR 175.300; where the FCS may be used in contact with all food types, except infant formula and breast milk, under Conditions of Use A through H, and the maximum level of the FCS in aqueous emulsions for can coatings or polymeric coatings on polyolefin film is 100 ppm, and the maximum level of the FCS in the aqueous emulsion of the can‐end or side‐seam cement is 150 ppm.
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 will not be prepared. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated April 29, 2016. The EA is incorporated by reference in this Finding of No Significant Impact, and is briefly summarized below. The EA was prepared in accordance with 21 CFR 25.40.
The FCS is intended to preserve polymer solution formulations. The notifier intends to sell the FCS to customers outside the United States. These customers are expected to use the formulations to make coatings which are then applied to food contact articles. The evaluation in the EA focuses on the use and disposal of the food contact articles that are used by a consumer in the US.
Food contact articles made with the FCS will be used nationwide, and therefore widely distributed and disposed of across the country. The food contact articles made with the FCS are expected to be recycled and discarded (metal cans) or predominantly discarded (flexible packaging). Consequently, the FCS has the potential to enter the environment via land disposal and incineration of municipal solid waste (MSW). 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. Additionally, when incinerated, the products of complete combustion for the FCS are not expected to alter the emissions from properly operating MSW combustion facilities. The greenhouse gases (GHG) anticipated upon combustion are carbon dioxide and nitrous oxide. The Council on Environmental Quality (CEQ) has established an annual GHG emissions threshold of 25,000 metric tons of carbon dioxide equivalents. When the CEQ GHG threshold is exceeded, quantitative disclosure is required. Based on confidential market volume information provided in a confidential attachment to the EA, estimated GHG emissions are below the CEQ GHG threshold.
Both the marginal amount of the FCS landfilled compared to all MSW landfilled, as well as the EPA’s regulations governing landfills (40 CFR Part 258), result in negligible amounts of the FCS expected to enter the environment (land, and to an even lesser extent water). Additionally, no significant quantities are expected to volatilize or release into the air upon use and disposal of the FCS (and as discussed above, the FCS will make up a very small portion of the total MSW combusted, and will not significantly alter the emissions from properly operating MSW combustion facilities, 40 CFR Part 60).
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 1649, as a preservative in polymer solution formulations (which are ultimately used in manufacturing food contact articles), will not significantly affect the quality of the human environment; therefore, an environmental impact statement will not be prepared.
Prepared by ____________________________________________Date: digitally signed on 07-21-2016
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 on 07-21-2016
Suzanne Hill
Environmental Team 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 April 29, 2016 EA for FCN 1649
Dated: July 21, 2016
U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of April 29, 2016 for food contact notification (FCN) 1649 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 provide the location of the following two references. One reference was outdated, and the other was not included. The following revisions are:
- Under Item 4, Description of the Proposed Action, the EA lists, http://www.epa.gov/smm/advancing‐sustainable‐materials‐management‐facts‐and‐figures‐report as the link to retrieve the following EPA report: “Advancing Sustainable Materials Management: 2013 Fact Sheet. Assessing Trends in Materials Generation, Recycling and Disposal in the United States, EPA530-R-15-003, U.S. Environmental Protection Agency, Office of Resource Conservation and Recovery (5306P), June 2015.” The corrected link should read, https://www.epa.gov/sites/production/files/2015-09/documents/2013_advncng_smm_rpt.pdf.
- Under Item 6, Introduction of Substances to the Environment, the EA does not include the reference to the Council on Environmental Quality’s Draft Guidance for Greenhouse Gas Emissions. The complete title and location of the document are, The Council on Environmental Quality (2014), Revised Draft Guidance for Greenhouse Gas Emissions and Climate Change Impacts.