Environmental Decision Memo for Food Contact Notification No. 1686
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See also Environmental Decisions.
Date: October 4, 2016
From: Biologist, Environmental Team, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject: Finding of No Significant Impact for Food Contact Notification (FCN) 1686 for 1,2- benzisothiazolin-3-one (CAS Reg. No. 2634-33-5), as a biocide in uncured liquid rubber latex used to manufacture repeat-use rubber gloves intended for use in contact with all types of food, except for use in contact with infant formula and human milk.
Notifier: Shanghai Miken Biotech Co., Ltd.
To: Vivian Gilliam, 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 FCN 1686 for 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5).
After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated July 17, 2016, may be made available to the public. We will post digital transcriptions of the FONSI 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.
Leah D. Proffitt
Attachment: Finding of No Significant Impact
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1686), submitted by Shanghai Miken Biotech Co., Ltd., to provide for the safe use of 1,2-benzisothiazolin-3-one (CAS Reg. No. 2634-33-5), as a biocide in uncured liquid rubber latex used to manufacture repeat-use rubber gloves intended for use in contact with all types of food, except for use in contact with infant formula and human milk.
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 prepared. This finding is based on information submitted by the notifier in an environmental assessment, dated July 17, 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 subject food-contact substance (FCS) functions as a preservative of latex emulsions used in the manufacture of latex gloves.
It is assumed that post-consumer disposal of gloves containing the FCS will be to landfills or municipal solid waste (MSW) combustion facilities complying with 40 CFR Parts 258 and 60, respectively. The FCS will not significantly alter the emissions from properly operating MSW combustion facilities, and incineration of the FCS will not cause these facilities to threaten a violation of applicable emissions laws and regulations at 40 CFR Part 60 and/or relevant state and local laws. Market volume information provided in a confidential attachment to the EA demonstrates that the FCS will comprise a very small portion of MSW generated in 2013, compared with U.S Environmental Protection Agency’s 2013 MSW statistics. In addition, based on the draft guidance document released by the Council on Environmental Quality (CEQ) in December 2014,[1] since total emissions as a result of combustion of the FCS are not expected to exceed 25,000 metric tons of carbon dioxide equivalent per year, quantitative disclosure of greenhouse gas emissions is not warranted.
Therefore, we find that use of the FCS as a biocide in uncured rubber latex will not cause significant adverse impacts on the human environment. Therefore, an environmental impact statement will not be prepared.
Prepared by __________________________________________Date: digitally signed 10-04-2016
Leah D. Proffitt
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by __________________________________________Date: digitally signed 10-04-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
[1] Council on Environmental Quality (CEQ). Revised Draft Guidance on Consideration of Greenhouse Gas Emissions and the Effects of Climate Change. December 18, 2014.