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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001108

Date:September 22, 2011
From:Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Office of Food Additive Safety (HFS-255)
Subject:FCN No. 1108–1,2-Benzisothiazolin-3-one as a biocide preservative in aqueous latex/silicone formulations used as coatings on metal substrates and polypropylene (PP) sheets.
Notifier:Lanxess Corporation
111 RIDC Park West Dr.
Pittsburgh, PA 15275
To:Division of Food Contact Notifications (HFS-275)
Attention: Vanee Komolprasert, Ph.D., P.E.
Through: Annette M McCarthy, PhD, Lead Environmental Review Scientist

Attached is the Finding of No Significant Impact (FONSI) for FCN 1108. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated August 4, 2011, 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.

 

Hoshing W. Chang, Ph.D.

 

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food-contact notification (FCN No. 1108), submitted by Lanxess Corporation, to provide for the safe use of 1,2-benzisothiazolin-3-one as a biocide preservative in aqueous latex/silicone formulations used as coatings on metal substrates and polypropylene (PP) sheets.

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, will not require the preparation of an environmental impact statement. This finding is based on information, including an environmental assessment, dated August 4, 2011, in the notification submitted by the notifier, and other information known to the agency as described below.

The FCS is used as a biocide preservative in aqueous latex/silicone formulations as coatings on metal substrates and polypropylene (PP) sheets in contact with food. The metal substrates and the PP sheets are anticipated to be used to form cans and PP containers, respectively. The primary environmental concern stems from disposal of products containing the FCS after consumer uses.

The FCS is anticipated to remain with the cans and PP sheets through manufacture and disposal of them. The EA discusses the low levels of combustion byproducts and total waste generated relative to that produced annually in the US. While these discussions did not contain quantitative data to support the finding, it is the experience of the Agency that the statements are valid.

 

To estimate the amount of FCS disposed from the proposed use, we estimated the most conservative scenario using the annual worldwide production of polymer emulsions. The world polymer emulsion industry produced approximately 9.9 million metric tons of polymer emulsions in 2010. If we assume that a) all of the emulsion polymer in the world were to be used to produce food container, b) all of those food containers are used and disposed of in the US, c) all food containers contain the FCS, and d) Lanxess Corporation occupies the entire market share for polymer emulsions, we can estimate the annual volume of FCS disposed per year as approximately 1,500 metric tons. Compared with the 243 million tons of municipal solid waste (MSW) generated in 2009 (U.S. Environmental Protection Agency. Municipal Solid Waste Generation, Recycling, and Disposal in the United States: Facts and Figures for 2009. EPA-530-F-010-021, December 2010, Washington DC), the worst case estimate of FCS generated due to proposed uses would represent an insignificant fraction of the MSW.

 

We anticipate that the cans are to be landfilled, combusted, or recycled. Based on current EPA statistics (EPA-530-F-010-021), approximately 51% of cans are recycled in the US each year. No significant impacts on the current can recycling programs are anticipated due to the low use levels of the FCS, and the fact that similar products are already in use. The remaining 49% of cans are either landfilled or combusted as rubbish. The proposed use of the FCS is not anticipated to have any impact on these municipal solid waste disposal rates. If landfilled, the FCS is not anticipated to be released to the environment when the landfill programs comply with the Federal, local, and state regulations. If combusted, the FCS thermally degrades to form CO2, H2O, NOx, and SOx.

 

We anticipate that the PP containers are also to be landfilled, combusted, or recycled. Based on current EPA statistic (EPA-530-F-010-021), approximately 7% of PP is recycled in the US. No significant impacts on the current PP recycling programs are anticipated due to the low use levels of the FCS. The rest of the 93% of the PP will either be landfilled or combusted as rubbish. The proposed use of the FCS is not anticipated to have any impact on municipal solid waste disposal rates. If landfilled, the FCS is not anticipated to be released to the environment when the landfill programs comply with the Federal, local, and state regulations. If combusted, the FCS thermally degrades to form CO2, H2O, NOx, and SOx.

 

The EA states that the FCS is used as a biocide preservative in aqueous latex/silicone formulations as coatings on metal substrates and polypropylene (PP) sheets in contact with food. No market share information was provided to the Agency. We can conservatively estimate a worst case scenario by assuming that 100% of the FCS is combusted. By doing so we estimate of the maximum levels of combustion byproducts as a result of the proposed use as CO2 (437 metric tons), NOx (457 metric tons), and SOx (436 metric tons). These levels represent insignificant fractions of the total concentration of the products produced as a result of combustion of municipal solid wastes, in million tons. Additionally, the degradation products will be collected on-site by scrubbers.

 

 

Prepared by __________________________________________Date: September 22, 2011
Hoshing W. Chang, Ph.D.
Regulatory Team 2
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: September 22, 2011
Annette M. McCarthy, Ph.D.
Lead Environmental Review Scientist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration