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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001371

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.


Date: January 9, 2014
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN 1371: 1,3-butadiene, 2-methyl-, homopolymer, of cis-1,4-configuration, cyclized (CAS No. 68441-13-4) for use as a modifier for ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers complying with 21 CFR 177.1360(a)(3) at a level not to exceed 27 weight-percent of the polymer blend.
Notifier: Zeon Corporation
 
To: Elizabeth Furukawa, Ph.D, Division of Food Contact Notifications (HFS-275)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
Attached is the Finding of No Significant Impact (FONSI) for the above referenced notification. After this becomes effective, copies of this FONSI and the notifier's environmental assessment, dated October 17, 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.
 
Talia A. Lindheimer
 
 Attachment:         Finding of No Significant Impact
 
File:    FCN 1371

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1371), submitted by Zeon Corporation to provide for the safe use 1,3-butadiene, 2-methyl-, homopolymer, of cis-1,4-configuration, cyclized (CAS No. 68441-13-4) for use as a modifier for ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers complying with 21 CFR 177.1360(a)(3) at a level not to exceed 27 weight-percent of the polymer blend.
 
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 (EA), dated October 17, 2013, as summarized below.
 
This notification has been submitted to support the use of the FCS for thin film applications, such as pouches and bag-in boxes, as well as molded (thick) articles, such as cup and bottles. The FCS notified herein is expected to used be in place of the polymer that is currently authorized for FCN 850, and therefore is not expected to result in a net increase in the use of energy and resources. The difference between the FCS and the polymer notified in FCN 850 are minor manufacturing differences. No significant environmental introductions are expected as a result of these differences such that the authorization of the FCS is not expected to result in any significant new introductions of chemicals or products into the environment.
 
Disposal of the food-contact materials that are not intended for recycling will be by conventional trash disposal and primarily by incineration or sanitary landfills. It is reasonably expected that there will not be leaching to the environment from disposal into landfills in light of the retention of the FCS by the food contact article and the Environmental Protection Agency’s (EPA) regulations which govern municipal solid waste landfills, i.e. 40 CFR Part 258. 
 
As previously mentioned, the FCS is expected to be incorporated into food-contact articles (bottles and cups) which may be recovered for recycling. The environmental assessment includes a discussion of a categorical exclusion under 21 CFR 25.32(i) to argue the absence of impacts on recycling.[1] This was not considered or used as a basis for the FONSI. We considered the information provided to support that the FCS is expected to be used as a substitute for EVOH or other EVOH-polymer blends already on the market. These polymers already on the market are also for use in the same food packaging applications. The replacement of the current marketed items suggests that the consumption of energy and resources as a result of the use and disposal of the FCS will be in amounts comparable to what is already in practice, and therefore supports that no impacts on the use of energy and resources, or the recycling stream, are expected.  
 
The FCS is composed of carbon, hydrogen and oxygen; such that the complete combustion of the FCS is not expected to significantly alter emissions from properly operating municipal solid waste combustors.  Market volume information provided in a confidential attachment to the EA supports that the combustion of the FCS in municipal waste combustors are not expected to threaten a violation of applicable emissions laws and regulations (40 CFR Part 60).   Based on the information provided, we have concluded that no toxic combustion products are expected as a result of the use and incineration of the FCS.
 
No extraordinary circumstances have been identified, which would otherwise indicate a significant environmental impact, as a result of the use and post-consumer disposal of these items.
 
Prepared by     _________________________________________Date: January 9, 2014
Talia A. Lindheimer
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by   __________________________________________Date: January 9, 2014
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]“FDA takes the position that an FCS that is used at levels of no more than 5% of the final article would not have any adverse impact on the environment regardless of the manner in which the article is disposed,” and cites the categorical exclusion listed under 21 CFR 25.32(i). Independent of the fact that the FCS is expected to be present at less than 5% wt of the article and retained through use and disposal, the use of FCS in bottles and cups would not otherwise qualify for a categorical exclusion under 25.32(i) as these articles are not food packaging[1].