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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001134

Date:December 21, 2011
From:Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Office of Food Additive Safety (HFS-255)
Subject:FCN No. 1134 – Copolymer of caprolactam, isophthalic acid, and isophoronediamine as a component of single- and repeated-use food contact articles.
Notifier:Lanxess Corp.
111 RIDC Park West Drive
Pittsburgh, PA 15275
To:Division of Food Contact Notifications (HFS-275)
Attention: Vanee Komolprasert, Ph.D., P.E.
Through: Annette M McCarthy, PhD, Senior Science and Policy Staff

Attached is the Finding of No Significant Impact (FONSI) for FCN 1134. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated October 14, 2011, 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. 1096), submitted by Lanxess Corporation, to provide for the safe use of a copolymer of caprolactam, isophthalic acid, and isophoronediamine as a component of single- and repeated-use food contact articles.

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 October 14, 2011, in the notification submitted by the notifier, and other information known to the agency as discussed below.

The projected amount of NO2 formation from incineration of the FCS, based on estimate of the fifth-year production of the FCS, is estimated to reach only a very small fraction of 2004 total NO2 emissions from anthropogenic sources (120.6 tonnes ÷ 17.1 million tonnes = 7.06 x 10-6). However, total anthropogenic NO2 includes nitrogen oxides from sources other than municipal waste combustion (MWC). A comparison of the notifier’s estimated emission of 120.6 tonnes with 2005 amounts from permitted large and small MWC units (49,000 tons)[1] provides the more conservative comparison follows: 120.6 tonnes ÷ (49,000 tons x 0.91 tons/tonne) = 120.6 tonnes ÷ 44,590 tonnes = 0.003

This constitutes a very small proportion of anthropogenic NO2 from MWC. Therefore, no significant impacts to the environment are anticipated as a result of the use and disposal of articles manufactured from the FCS.

 

[1] From EPA Memorandum “Emissions from Large and Small MWC Units at MACT Compliance,” 8/10/2007

 

Prepared by __________________________________________Date: December 21, 2011
Leah D. Proffitt
Biologist
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: December 21, 2011
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