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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. 001208

 

August 1, 2012
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
To: Division of Food Contact Notifications (HFS-275)
Attention: Paul Honigfort, Ph.D.
 
Subject: FCN No. 1208 – 1,2-Benzisothiazolin-3-one as a biocide in uncured liquid rubber latex used to manufacture repeat-use rubber gloves, as a use level of 0.05% b.w.
 
Notifier: Prom Chem Ltd.
 
 Attached is the Finding of No Significant Impact (FONSI) for FCN 1208. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated June 25, 2012, 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. 1208), submitted by Prom Chem Ltd., 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, as a use level of 0.05% b.w.
 
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 submitted by the notifier in an environmental assessment, dated June 25, 2012 as summarized below.
 
Biocides are in widespread use in the production of latex gloves. The notifier states in the EA that the FCS is not expected to adversely affect the use of energy and natural resources, as it is intended to replace similar substances already used in the manufacture of rubber gloves. This FCN becoming effective is not expected to lead to an increase in the use of biocides or latex gloves. Therefore, we find that there will be no increase in the amount of municipal solid waste that is produced.
 
Under Item 4. of the EA, the notifier states that there are no “special circumstances” surrounding the use or disposal of gloves made with the FCS. We note that the correct legal term, pursuant to 21 CFR 25.21, is “extraordinary circumstances.” Extraordinary circumstances include potential for serious harm to the environment at the expected exposure level, and adverse effects on endangered species habitat. No extraordinary circumstances are expected as a result of this FCN becoming effective.
 


 

 
 
Prepared by     __________________________________________Date: August 1, 2012
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: August 1, 2012
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration