Food

Environmental Decision Memo for FCN No. 001148

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or
the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.


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

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