Environmental Decision Memo for Food Contact Notification No. 001354

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: November 6, 2013

From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: FCN No. 1354 – Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine [Nylon 6/66] as a component of films intended to contact food.

Notifier: UBE Corporation Europe, S.A.

To: Kelly Randolph, MPH, 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 FCN 1354. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated October 21, 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.

Leah D. Proffitt

Finding of No Significant Impact

File: FCN No. 1354


A food-contact notification (FCN No. 1354), submitted by UBE Corporation Europe, S.A., to provide for the safe use of Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine, a.k.a. Polyamide 6/66 (PA 6/66), Nylon 6/66, as a component of films intended to contact food.

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 October 21, 2013, as summarized below.

The FCS is intended to be used in films such as cook-in-bag/packaging film applications, and in multi-layer film applications at temperatures up to 375°F for 4 hours. Migration of the FCS from the packaging into the environment is expected to be minimal. Therefore, the primary environmental concern with such products is related to land disposal and combustion at permitted facilities, and recycling practices.

According to waste disposal statistics from EPA’s 2010 Municipal Solid Waste (MSW) Report, [1] of the total municipal solid waste (MSW) generated in 2010, 54.3 % was land disposed, 11.7 % combusted, and 34.0 % recovered for recycling (excluding waste recovered for composting). However, since the FCS will be used in items that are not expected to be recycled (i.e. films and bags contaminated with food residues), the main route of environmental introduction will be via land disposal or combustion. Thus, the disposal patterns have been adjusted as follows: 17.7 % of food packaging materials containing the FCS will be combusted annually, with 82.3 % being land disposed. This amount is calculated as follows: 11.7 % combusted ÷ (11.7 % combusted + 54.3 % land disposed) = 17.7 % combusted. The remaining 82.3 % will be land disposed.

With regard to combustion, the FCS is composed of carbon, hydrogen, nitrogen, and oxygen-elements that are commonly found in municipal solid waste. The products of complete combustion would be carbon dioxide, water and potentially nitrogen oxides.

Based on the proposed use of the FCS and the expected market volume (CBI), the FCS will make up a very small portion of the total municipal solid waste currently combusted. The FCS will not significantly alter the emissions from permitted municipal solid waste combustors, and, therefore, incineration of the FCS will not cause municipal solid waste combustors to threaten a violation of applicable emissions laws and regulations (40 CFR Part 60 or relevant state and local laws).

Furthermore, in light of EPA's regulations governing municipal solid waste landfills (40 CFR Part 258), only extremely small amounts, if any, of the FCS are expected to enter the environment as a result of the landfill disposal of food contact articles comprised of the FCS.

The FCS contains nitrogen which may produce nitrogen oxides (NOx) when combusted with other municipal solid waste materials. Such nitrogen oxides have the potential to contribute to acid precipitation.[2] The potential nitrogen dioxide (NO2) emissions produced from combustion of the FCS are estimated in confidential market volume projections and compared with the amount of NOx emissions from large municipal waste combustion (MWC) units.

According to a June 2002 EPA memorandum (the most recent data available), significant emissions reductions were achieved at large MWCs, after Maximum Achievable Control Technology (MACT) retrofit of these facilities. This memo shows that, in 2000, NO2 emissions at large MWC plants were 46,500 short tons/yr.[3] Comparison of this amount with the projected confidential market volume shows that NO2 emissions from the proposed use and disposal of the FCS represent a small fraction—on the order of hundredths of a percent—of year 2000 NO2 emissions from large MWC facilities. Therefore, we do not expect the proposed use and disposal vial MWC to cause significant environmental impacts from nitrogen dioxide emissions.

In conclusion, no significant environmental impacts are anticipated from the proposed use and disposal of the FCS.

Prepared by __________________________________________Date: November 6, 2013
Leah D. Proffitt
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: November 6, 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. Environmental Protection Agency. Municipal Solid Waste Generation, Recycling, and Disposal in the United States: Facts and Figures for 2010. EPA-530-F-011-005, November 2011, Washington, DC.

[2] Combustion Modification Control of Nitrogen Oxides; EPA/600/F-95-012; U. S. Environmental Protection Agency; Office of Research and Development, National Risk Management Research Laboratory: Research Triangle Park, NC, Aug. 1995.

[3] Memorandum to Docket from Walt Stevenson, Combustion Group, Emission Standards Division, OAQPS regarding Emission from Large MWC Units at MACT Compliance, EPA Document ID EPA-HQ-OAR-2003-0072-0017 available at!documentDetail;D=EPA-HQ-OAR-2003-0072-0017

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