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U.S. Department of Health and Human Services

Food

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Environmental Decision Memo for Food Contact Notification No. 001111

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. FCN No. 1111–1,2-Benzisothiazolin-3-one 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.
Notifier:Thor GmbH of Speyer Germany
Landwehrstr. 1
Speyer, RP 67346 Germany
To:Division of Food Contact Notifications (HFS-275)
Attention: Vivian Gilliam
Through: Annette M McCarthy, PhD, Lead Environmental Review Scientist

Attached is the Finding of No Significant Impact (FONSI) for FCN 1111. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated August 17, 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. 1111), submitted by Thor GmbH of Speyer Germany, to provide for the safe use of 1,2-benzisothiazolin-3-one 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.

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 17, 2011, in the notification submitted by the notifier, and other information known to the agency as described below.

The FCS is anticipated to remain with the gloves through manufacture and disposal of the gloves. 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. Based on the information available to FDA in the EA for FAP 3B4389, we can estimate that food contact market for gloves manufactured from latex produced in the US in 1995 is approximately 12 million pair annually. A pair of gloves weighs about 85 grams. Each glove contains no more than 0.05 percent of the FCS by weight of latex solids for the proposed use. Therefore, the amount of the FCS used as biocide in uncured liquid rubber latex can be estimated to be less than 0.51 metric tons per year (= 5 gram FCS/100 gram latex solids x 85 gram latex solids/pairs of gloves x 12,000,000 pairs of gloves/year x 10-6 metric tons/gram) if Thor GmbH were to occupy all the market shares of the entire 1,2-benzisothiazolin-3-one production for latex gloves manufactured in the US; a worst-case scenario that the Agency believes is unlikely. We further anticipate that the demand for latex gloves for food uses in the US is not likely to be significantly increased in the near future. Therefore, compared to 243 million tons of municipal solid waste (MSW) generated in 2009, the worst-case estimated amount of FCS generated due to proposed uses would be much less than that of the MSW.

 

If properly disposed, the gloves are expected to be lanfilled or combusted. If landfilled, the FCS is not anticipated to be released to the environment provided that 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 estimated amounts of CO2 (0.15 metric tons), NOx (0.16 metric tons), and SOx (0.22 metric tons) are anticipated to be extremely small compared with that resulted from 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