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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001222

 

November 5, 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: Helen H. C. Lee, Ph.D.
 
Subject: FCN No. 1222 – Co-poly alpha olefins (C20 – C30) as an additive for polypropylene sheets at a level not exceeding 10%.
 
Notifier: Idemitsu Kosan Co., Ltd.
 
 Attached is the Finding of No Significant Impact (FONSI) for FCN 1222. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated December 20, 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.
 
 
Leah D. Proffitt
 
 
 
 
 
 
 
Attachment:         Finding of No Significant Impact
 
           


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1222), submitted by Idemitsu Kosan Co., Ltd., to provide for the safe use of co-poly alpha olefins (C20 – C30) as an additive for polypropylene sheets at a level not exceeding 10%.
 
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 December 20, 2011, as summarized below.
 
This conclusion is based on the understanding that introduction of the FCS into the environment is expected to occur chiefly via land disposal. We have reviewed the data compiled by EPA for MSW generation in 2010. Of the total 250 million tons generated, plastic containers and packaging constituted approximately 13 million tons, of which polypropylene was roughly 2 million tons. Therefore, polypropylene contributes only 0.008% to total MSW. 
 
Due to existing EPA regulation of MSW landfills and incineration facilities in 40 CFR Parts 60 and 258, we do not expect significant environmental impacts arising from the proposed use when articles containing the FCS are properly disposed of. Of the 2.03 million tons of PP containers generated as waste, 1.9 million are discarded, leaving only 40,000 tons—or 2%—which are recycled. Due to the modest recycling rate of polypropylene, we do not expect significant impacts on recycling as a result of the proposed use of the FCS.
 


 

 
 
Prepared by     __________________________________________Date: November 5, 2012
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: November 5, 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