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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001318

 

Date: August 1, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1318 – 1, 4-Benzendicarboxylic acid, 1, 4-dimethyl ester, polymer with 1,4-butanediol and α-hydro-ω-hydroxypoly(oxy-1,4-butanediyl) (aka PBT/PTMG copolymer), as an additive in food contact polyethylene terephthalate (PET) polymer.
Notifier: Unitika, Ltd.
 
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____
 
 
Attached are the Finding of No Significant Impact (FONSI) and our supplement to the record for FCN 1318. After this notification becomes effective, copies of this FONSI, the supplement, and the notifier's environmental assessment, dated January 25, 2013, may be made available to the public. We will post digital transcriptions of the FONSI, the supplement, 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
                                FCN 1318 Attachment 5 “Determination of Major Impurities in PBT/PTMG Copolymer (2): Additional analysis”
 
           


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1318), submitted by Unitika, Ltd., to provide for the safe use of 1, 4-Benzendicarboxylic acid, 1, 4-dimethyl ester, polymer with 1,4-butanediol and α-hydro-ω-hydroxypoly(oxy-1,4-butanediyl) (aka PBT/PTMG copolymer), as an additive in food contact polyethylene terephthalate (PET) polymer.
 
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 25, 2013, in the notification submitted by the notifier, our supplement to the record and other information known to the agency.
 
The FCS, also referred to as PBT/PTMG, is intended for use as a polymer additive for PET films, to be used at a maximum level of 20% wt.   The intended technical effect of the FCS is to improve the tearing property of PET films, which will allow for food packaging to be opened smoothly.  In the identification of the chemical substance under Item 5, the EA identifies the FCS as 1,4-Benzendicarboxylic acid, dimethyl ester, polymer with 1,4-butanediol and α-hydro-ω-hydroxypoly(oxy-1,4-butanediyl) (CAS No. 9078-71-1). This is a synonym to the name provided on Form 3480 of the FCN, along with the draft acknowledgement letter of 1,4-Benzendicarboxylic acid, 1,4-dimethyl ester, polymer with 1,4-butanediol and α-hydro-ω-hydroxypoly(oxy-1,4-butanediyl). 
 
In item 6.b., introduction of substances into the environment as a result of use, the EA states the FCS and PET production facilities operate in compliance with the environmental regulations of Japan; however, once the FCN becomes effective, the notifier may sell the FCS to any PET manufacturer, regardless of location. The limitations on the use of the FCS will not restrict use to PET film manufacture outside of the US. Therefore, we estimated potential environmental impacts based on the reasonable assumption that the FCS may be used in the US.  We believe the facilities which produce FCS-containing films will dispose waste materials, e.g. plant scraps, in accordance with established procedures and regulations.
 
The FCS is expected to be fully incorporated into PET films, such that disposal of food-contact films containing the FCS is expected to represent the primary route of environmental introduction. The discussion in Item 7, fate of substances in the environment, states the fate of the FCS will be the same as the PET film released into the environment. While we understand the fate of the FCS, in literal terms, is that it will be disposed of as a component of the PET film, the physicochemical properties differ such that combustion byproducts and any leachate of the FCS cannot be reasonably expected to be the same as the film. We incorporate into this FONSI, the physicochemical properties listed on Form 3480; specifically under Part II: Chemistry Information, Section C(2)(a). Furthermore, due to the low migration of components from the disposed PET articles, and applicable EPA regulations at 40 CFR Part 258 governing MSW landfills, we believe no significant environmental introductions are expected from disposal of items containing the FCS. Disposal of these products occur primarily via land disposal at permitted municipal solid waste (MSW) landfills, with some small amounts being incinerated. There is very limited, if any, recycling of food-contact films in the United States. Due to federal regulations governing MSW landfills and incineration facilities, we do not expect significant adverse effects from use, land disposal or incineration of food-contact films containing the FCS.  
 
There is a possibility of minute amounts of the FCS entering wastewater treatment facilities: once ingested, the FCS would be expected to survive digestion and be excreted from the body, thereby entering the wastewater stream. The dietary concentration (DC) resulting from ingestion is calculated to be less than 50 ppb (FCN Attachment 5, “Determination of PTB/PTMG Copolymer from PET film”). The daily existing flow for publicly-owned treatment works (POTWs) is 32,345 million gallons, therefore the concentration of the FCS in relation to the annual flow will be low. We cite the Clean Watersheds Needs Survey, 2008 Report to Congress, U.S. EPA, 2008 to support this assumption.[1] This comparison of the dietary concentration to POTW flow assumes the maximum potential value for the amount of the FCS that will transfer from the film to the food, and subsequently be ingested and thus excreted by humans into the wastewater. An overly conservative assumption that all wastewater entering the POTW contains the FCS at a concentration of 50 ppb, and accounting for dilution of the POTW outflow through dilution in the receiving body, we estimate the environmental concentration of 5 ppb.  
 
 
 
 
 
 
 
 
 
 
 
Prepared by     __________________________________________Date: August 1, 2013
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: August 1, 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. EPA (2008). Clean Watersheds Needs Survey, 2008 Report to Congress. Washington (DC): U.S. Environmental Protection Agency (U.S. EPA). Available at: http://water.epa.gov/scitech/datait/databases/cwns/toc.cfm.