Environmental Decision Memo for Food Contact Notification No. 1479

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.

December 17, 2014

From: Biologist, Environmental Team, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: FCN No. 1479 – 1-Pentene, 4-methyl-, polymer with 1-propene (CAS Reg. No. 25119-95-3), as a component of articles used in contact with food, including repeat-use infant bottle applications.The FCS may be used in contact with all food types under Conditions of Use A through H. Adjuvant substances permitted for use in olefin polymers complying with 21 CFR §177.1520(c), items 3.1 and 3.3 may be used in the subject copolymer, provided that the limitations on the use of the adjuvant substances are met.

Notifier: Mitsui Chemicals, Inc.

To: Vivian M. Gilliam, 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 1479. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated September 18, 2014, may be made available to the public.We will post digital transcriptions of the FONSI and 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. 1479), submitted by Mitsui Chemicals, Inc., to provide for the safe use 1-Pentene, 4-methyl-, polymer with 1-propene (CAS Reg. No. 25119-95-3), as a component of articles used in contact with food, including repeat-use infant bottle applications.The FCS may be used in contact with all food types under Conditions of Use A through H. Adjuvant substances permitted for use in olefin polymers complying with 21 CFR §177.1520(c), items 3.1 and 3.3 may be used in the subject copolymer, provided that the limitations on the use of the adjuvant substances are met.

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 September 18, 2014, as summarized below.

The FCS is a copolymer that is intended for use in the fabrication of articles that are produced by extrusion, injection molding, blow molding, and compression molding.Particularly, articles manufactured with the copolymer include both single and repeat-use food-contact articles such as packaging, sheets, and containers. The notifier will be selling the FCS to manufacturers who produce the food-contact materials. These materials will be widely distributed across the country and therefore assumed to be disposed of nationwide.It is expected that about 82% will be land disposed with the remaining 18% incinerated.^[1]

The types of articles which contain the FCS are expected to be disposed of via traditional land disposal.The FCS is a high molecular weight polymer that will be retained by the food contact articles and therefore is expected to remain with the article through use and disposal.In light of the Environmental Protection Agency’s (EPA) regulations governing municipal solid waste landfills (40 CFR Part 258) and the retention of the FCS, it is reasonably expected that the disposal will not result in significant introductions to the environment.Furthermore, the incineration of these articles will result in a complete breakdown of the FCS, such that the complete combustion of the FCS copolymers will be expected to produce carbon dioxide and water.In a confidential attachment to the EA, the reported market volume information further supports the combustion of the FCS in municipal waste combustors will not threaten a violation of applicable emissions laws and regulations, i.e., 40 CFR Part 60.The market volume is protected from disclosure under 18 U.S.C. 1905 and 21 U.S.C. 331(j).

Therefore, we do not expect a significant impact to the environment as a result of the use and disposal of articles manufactured from the FCS.

Prepared by __________________________________________Date: see electronic signature
Talia A. Lindheimer
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by _____________________________________________Date: see electronic signature
Suzanne Hill
Environmental Team Lead
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

^[1] United States Environmental Protection Agency - Municipal Solid Waste Generation, Recycling, and Disposal in the United States: Facts and Figures for 2012, http://www.epa.gov/osw/nonhaz/municipal/pubs/2012_msw_fs.pdf. According to this report, of the total of 250.9 million tons of municipal solid waste (MSW) generated in 2012, 53.8% generally was land disposed, 11.7% was combusted, and 34.5% was recovered (a combination of waste recovered for recycling and for composting). To adjust for the fact articles manufactured with the FCS are not expected to be recycled, the disposal pattern was calculated based on only the quantities of MSW that are land disposed or combusted. On this basis, it is estimated that 18% of food packaging materials containing the FCS will be combusted annually. This amount is calculated as follows: 11.7% combusted ÷ (11.7% combusted + 53.8% land disposed) = 17.8% combusted. The remaining 82.2% will be land-disposed.