Environmental Decision Memo for Food Contact Notification No. 1643
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See also Environmental Decisions.
Date: February 16, 2016
From: Biologist, Environmental Review Team, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject: Food Contact Notification (FCN) 1643 - Poly[(butylenesuccinate)-co-adipate] cross-linked with malic acid for use in coatings, films, molded articles, and thermoformed articles, under Conditions of Use C through G. The food-contact substance is not intended for use in contact with infant formula and breast milk.
Notifier: PTT MCC Biochem Company Limited
To: Kelly Randolph, D.V.M, M.P.H., Division of Food Contact Notifications (HFS-275)
Through: Suzanne Hill, Environmental Team Lead, Office of Food Additive Safety, (HFS-255)
Attached is the Finding of No Significant Impact (FONSI) for FCN 1643. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated February 3, 2016, 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 (FCS).
Talia A. Lindheimer
Attachment: Finding of No Significant Impact
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1643), submitted by PTT MCC Biochem Company Limited, to provide for the safe use of poly[(butylenesuccinate)-co-adipate] cross-linked with malic acid for use in coatings, films, molded articles, and thermoformed articles, under Conditions of Use C through G. The food-contact substance is not intended for use in contact with infant formula and breast milk.
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 February 3, 2016, as summarized below.
The FCS is intended to be used in the manufacture of food-contact articles, including films, coatings, molded articles, and thermoformed articles. Examples of food packaging materials that may be prepared from the FCS include stand-alone films used as food wraps, coatings on paper and paperboard, laminate seals for flexible packaging, injection molded food-contact articles, and thermoformed food-contact articles such as food trays. The FCS is a soft and flexible polymer that provides greater adhesion strength compared to current polymers in the market; additionally the FCS is intended to provide a protective layer that prevents food from penetrating into the paper and paperboard structure, which would otherwise lead to soaking and reduced structural strength. The FCS will be sold to manufacturers who produce food-contact materials, and these final materials will be widely distributed across the country, and therefore disposed of nationwide.
Post-consumer disposal of the articles which contain the FCS will be to landfills or municipal waste combustion (MWC) facilities complying with 40 CFR Parts 258 and 60, respectively. The FCS will not significantly alter the emissions from properly operating MWC units, and incineration of the FCS will not cause municipal waste combustors to threaten a violation of applicable emissions laws and regulations at 40 CFR Part 60 and/or relevant state and local laws. Market volume information provided in a confidential attachment to the EA demonstrates that the FCS will comprise a very small portion of municipal solid waste (MSW) generated in 2013, compared with EPA MSW statistics.[1] In addition, based on draft guidance document released by the Council on Environmental Quality (CEQ) in December 2014,[2] because total emissions as a result of the combustion of the FCS are not expected to exceed 25,000 metric tons of carbon dioxide per year[3], a quantitative analysis of carbon dioxide emissions was not conducted.
It is also assumed, conservatively, that post-consumer disposal of FCS-containing food-contact articles will not include recycling and that the FCS containing articles are expected to be disposed according to the same patterns as what is already in practice, and therefore will not result in an increase the use of resources and energy.
Therefore, FDA has found that the proposed use of the FCS in the above described food-contact articles does not present significant environmental impacts, and an environmental impact statement will not be prepared.
Prepared by __________________________________________Date: digitally signed 02-16-2016
Talia A. Lindheimer
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by __________________________________________ Date: digitally signed 02-19-2016
Suzanne Hill
Environmental Team Lead
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
[1]Advancing Sustainable Materials Management: Facts and Figures
[2]Council on Environmental Quality (CEQ). Revised Draft Guidance on Consideration of Greenhouse Gas Emissions and the Effects of Climate Change. December 18, 2014.
[3] As documented in a confidential attachment to the EA.