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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. 001301

 

Date: June 20, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1301 – Ethylene/propylene copolymers polymerized in the presence of propylene homopolymer complying with 21 C.F.R. § 177.1520(c), Item 1.1, to produce an inseparable blend of the two polymers as the basic polymer in the production of single- and repeated-use articles intended to contact all types of food.
Notifier: Equistar Chemicals, LP (a subsidiary of LyondellBasell Industries)
 
To: Anita Chang, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Annette M. McCarthy, Ph.D., Senior Science and Policy Staff____
 
For repeat-use applications of the FCS, the notifier submitted a claim of categorical exclusion under 21 CFR 25.32(j); however, the claim did not include a statement of compliance with the categorical exclusion criteria, as required under 21 CFR 25.25(a). Thus, the categorical exclusion is not warranted. The environmental assessment discusses all relevant aspects of use and disposal of items manufactured with the FCS for both single and repeat uses and was used to assess the potential environmental impacts of all uses.
 
Attached is the Finding of No Significant Impact (FONSI) for FCN 1301. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated May 10, 2013, 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. 1301), submitted by Equistar Chemicals, L.P., Inc., to provide for the safe use of ethylene/propylene copolymers polymerized in the presence of propylene homopolymer complying with 21 C.F.R. § 177.1520(c), Item 1.1, to produce an inseparable blend of the two polymers as the basic polymer in the production of single- and repeated-use articles intended to contact 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 submitted by the notifier in an environmental assessment, dated May 10, 2013 as summarized below.
 
The FCS is intended to be used in a manner consistent with other similar polymeric materials. The FCS is expected to remain with food contact materials through use and disposal by the consumer. Therefore, the primary environmental concern is related to land disposal and combustion at permitted facilities, and recycling practices.
 
The FCS blend will replace similar materials that are used to fabricate food-contact articles in the market. As the resources and energy required to utilize these materials are roughly equivalent and recyclability is not altered, the proposed action is not anticipated to result in a net increase in the uses of energy and resources, including effects on recycling of materials. Furthermore, the total market volume anticipated to be manufactured in 2013, and provided in a confidential attachment to the EA, is expected to be a small amount compared to the 250 million tons of municipal solid waste generated in 2010 and is expected to be substitutional for products already on the market. [1]   Therefore, we do not expect significant environmental impacts from the use and disposal of the FCS.
 
 
 
 
 
 
 
Prepared by     __________________________________________Date: June 20, 2013
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: June 20, 2013
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


[1]U.S. Environmental Protection Agency. Municipal Solid Waste Generation, Recycling, and Disposal in the United States: Facts and Figures for 2010. EPA-530-F-011-005, November 2011, Washington, DC.