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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001262

 

Date:       February 20, 2013
From:      Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject:   FCN 1262 - Polyethylene terephthalate copolyesters (including isophthalic acid and/or diethylene glycol modified) that otherwise comply with 21 CFR 177.1630 or an applicable effective Food Contact Notification, containing up to 0.85 weight percent sodium dimethyl 5-sulfoisophthalate units for use as films or articles intended to contact food types I, II, IV-B, VI (containing up to 15 percent alcohol), VII-B, and VIII, under Conditions of Use C through G.
 
Notifier: INVISTA (Naderland) B.V.
 
To: Vanee Komolprasert, Ph.D., P.E., Division of Food Contact Notifications (HFS-275)
 
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff__­___  
 
 
The notifier submitted claim of categorical exclusion under 21 CFR 25.32 (j) for the proposed use of the FCS as a component of a food contact article intended for repeated use. An EA was submitted for the remaining uses of the FCS as a component of articles that are not considered repeat use.
 
We have reviewed the claim of a categorical exclusion and have concluded that categorical exclusion is warranted.  The claim of categorical exclusion cites the sections, 21 CFR 25.32 (j), under which categorical exclusion is warranted, states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.
 
Attached is the Finding of No Significant Impact (FONSI) for FCN 1262.  After this notification becomes effective, copies of this FONSI and the notifier’s environmental assessment, dated January 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.
 
 
 
Talia A. Lindheimer
 
 
 
Attachment:   Finding of No Significant Impact
 
             



FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1262), submitted by INVISTA (Naderland) B.V., to provide for the safe use of polyethylene terephthalate copolyesters (including isophthalic acid and/or diethylene glycol modified) that otherwise comply with 21 CFR 177.1630 or an applicable effective Food Contact Notification, containing up to 0.85 weight percent sodium dimethyl 5-sulfoisophthalate units for use in films or articles intended to contact food types I, II, IV-B, VI (containing up to 15 percent alcohol), VII-B, and VIII, under Conditions of Use C through G.
 
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 January 10, 2013.
 
A discussion of specific uses of the FCS, other than a general description of the use for films or articles which are intended to contact food types I, II, IV-B, VI (containing up to 15 percent alcohol), VII-B, and VIII, under Conditions of Use C through G, was not provided by the notifier.  However, PET polymers are known to be used heavily in food packaging, particularly for soda bottles and flexible food packaging films. The FCS is expected to be used in a manner consistent with other PET products on the market.
 
Disposal of the food-contact materials, which contain the FCS, will be by conventional trash disposal and primarily by incineration or sanitary landfills. While the disposal of films is not specifically addressed, is reasonably expected that the disposal of these articles containing the FCS will be via conventional trash disposal. This is likely because of the difficulty of cleaning films that have residual food adhering to them.  It is reasonably expected that there will not be leaching to the environment from disposal into landfills in light of the Environmental Protection Agency’s (EPA) regulations, which govern municipal solid waste landfills. 
 
The FCS is combustible, and is expected to produce carbon dioxide, water, sulfur dioxide and sodium. Market volume information provided in a confidential attachment to the EA, which support 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). Furthermore, the byproduct sodium is expected to be present in the incinerator ash. 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.
 
The subject copolymers of this FCN have comparable or identical performance properties as other versions of PET that are already being used for manufacturing food contact articles. It is reasonably expected that PET articles manufactured with the FCS will not impact the PET recycling process, and no significant impacts will occur as a result of this use.
 
No extraordinary circumstances have been identified, which would otherwise indicate a significant environmental impact, as a result of post-consumer disposal of these items.
 
 
 
Prepared by     _____________________________________Date: February 20, 2013
Talia A. Lindheimer
Biologist
Office of Food Additive Safety        
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by   _____________________________________Date: February 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