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U.S. Department of Health and Human Services

Food

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Environmental Decision Memo for FCN No. 001148

 

February 13, 2012
From: Senior Science and Policy Staff (HFS-205)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
To: Division of Food Contact Notifications (HFS-275)
Attention: Mark Hepp, PhD
 
Subject:  FCN No. 1148 – 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (CAS Reg. No. 128-44-9) as nucleating agent to improve mechanical and technical properties in polyethylene terephthalate (PET) polymers complying with 21 CFR 177.1630 at levels not exceeding 0.1% by weight.
 
Notifier: WTConsulting GmbH on behalf of ADEKA Corporation, Switzerland
 
Attached is the Finding of No Significant Impact (FONSI) for FCN 1148. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 26, 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.
 
Berhane G. Girmay, PhD, PMP
 
 
Attachment:
Finding of No Significant Impact
 


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1148), submitted by WTConsulting GmbH., to provide for the safe use of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (CAS Reg. No. 128-44-9) as nucleating agent to improve mechanical and technical properties in polyethylene phthalate (PET) polymers complying with 21 CFR 177.1630 at levels not exceeding 0.1% by weight.
 
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 January 26, 2012, in the notification submitted by the notifier, and other information known to the agency.
 
Prepared by     __________________________________________Date: February 13, 2012
Berhane G. Girmay, PhD, PMP
Senior Science and Policy Staff
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: February 13, 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