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Environmental Decision Memo for Food Contact Notification No. 1660

Environmental Decision Memo for Food Contact Notification No. 1660

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: July 25, 2016

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

Subject: Finding of No Significant Impact for Food Contact Notification (FCN) 1660 for 1,3-benzenedicarboxamide, N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl) (CAS Reg. No. 42774-15-2), as a processing stabilizer in polyamide (PA) and ethylene/vinyl alcohol (EVOH) copolymers complying with applicable authorizations, except for use in contact with infant formula and breast milk

Notifier: Clariant Plastics & Coatings USA, Inc.

To: Vivian Gilliam, Division of Food Contact Notifications (HFS-275)
Through: Suzanne Hill, Environmental Supervisor, Office of Food Additive Safety, HFS-255

Attached is the Finding of No Significant Impact (FONSI) for FCN 1660 for 1,3-benzenedicarboxamide, N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl) (CAS Reg. No. 42774-15-2).

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated June 21, 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.

Leah D. Proffitt

Attachment: Finding of No Significant Impact


FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1660), submitted by Clariant Plastics & Coatings USA, Inc., to provide for the safe use of 1,3-benzenedicarboxamide, N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl) (CAS Reg. No. 42774-15-2), as a processing stabilizer in polyamide (PA) and ethylene/vinyl alcohol (EVOH) copolymers complying with applicable authorizations, except 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, an environmental impact statement will not prepared. This finding is based on information submitted by the notifier in an environmental assessment, dated June 21, 2016. The EA is incorporated by reference in this Finding of No Significant Impact, and is briefly summarized below. The EA was prepared in accordance with 21 CFR 25.40.

The subject food-contact substance (FCS) will be used as a processing stabilizer as follows:

  1. levels up to 0.3% in PA food-contact films not exceeding 100 μm thickness when used in contact with fatty foods;
  2. levels up to 0.2% in PA food-contact films not exceeding 50 μm thickness when used in contact with aqueous, acidic and alcohol containing foods; and,
  3. levels up to 0.2% in EVOH copolymers used as the nonfood-contact layer in multilayer films. The FCS/EVOH layer will not exceed 12 μm. The food-contact layer shall be any polymer that is authorized for such use by regulation or effective FCN.

It is assumed that post-consumer disposal of FCS-containing food-contact articles will be to landfills or municipal solid waste (MSW) combustion facilities complying with 40 CFR Parts 258 and 60, respectively. The FCS will not significantly alter the emissions from properly operating MSW combustion facilities, and incineration of the FCS will not cause these facilities 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 MSW generated in 2013, compared with U.S Environmental Protection Agency’s 2013 MSW statistics. In addition, based on the draft guidance document released by the Council on Environmental Quality (CEQ) in December 2014,[1] since total emissions as a result of combustion of the FCS are not expected to exceed 25,000 metric tons of carbon dioxide per year, a quantitative analysis of carbon dioxide emissions was not conducted.

The only potential source of environmental introduction of the FCS is via consumption and subsequent elimination of the FCS that may migrate from the food-contact films to food. Dietary exposure to the FCS via migration is estimated to be 44.7 ppb. This amount is assumed, conservatively, to be the environmental introduction concentration (EIC); as the EA does not assume the FCS will be metabolized during consumption. The lowest ecotoxicity endpoint for the FCS is 1.0 mg/L (= 1000 ppb), No Observable Effects Concentration, algae. This NOEC value is over 20 times higher than the EIC (1000 ppb ÷ 44.7 ppb = 22.4), thereby providing an adequate margin of safety. Therefore, it is not necessary to calculate the expected environmental concentration (EEC). An EEC is typically quantified using factors such as, degradation and dilution of the FCS in wastewater treatment facilities.

Therefore, we find that use of the FCS as a processing stabilizer in PA and EVOH copolymers will not cause significant adverse impacts on the human environment. Therefore, an environmental impact statement will not be prepared.
Prepared by __________________________________________Date: digitally signed 07-25-2016
Leah D. Proffitt
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 07-25-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

[1] Council on Environmental Quality (CEQ). Revised Draft Guidance on Consideration of Greenhouse Gas Emissions and the Effects of Climate Change. December 18, 2014.