• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

Environmental Decision Memo for Food Contact Notification No. 001223

 

October 18, 2012
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
To: Division of Food Contact Notifications (HFS-275)
Attention: Vanee Komolprasert, Ph.D., P.E.
 
Subject: FCN No. 1223 – Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine (Nylon6/66) as a component of multi-layer food-contact films.
 
Notifier: BASF Corporation
 
 Attached is the Finding of No Significant Impact (FONSI) for FCN 1223. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated October 4, 2012, 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. 1223), submitted by BASF Corporation, to provide for the safe use of hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine (Nylon6/66) as a component of multi-layer food-contact films.
 
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 4, 2012 as summarized below.
 
This conclusion is based on the understanding that disposal of the FCS is expected to occur via sanitary landfill or incineration at rates of 80% and 20% respectively. Land disposal is not expected to cause significant impacts due to existing EPA regulations governing municipal solid waste landfills. Incineration at permitted municipal waste combustion (MWC) facilities will result in emissions of oxides of nitrogen (NOx) in addition to carbon dioxide and water. Confidential market volume information provided by the notifier was used to estimate potential NO2 emissions from combustion of articles containing the FCS. This amount will not lead to a significant increase above NO2 emissions nationwide from MWC units.
 
However, we note that the confidential attachment contains some typographical errors: the notifier mistakenly states “Total NO2 emissions in U.S. = […].” It is clear that what is meant is total emissions from combustion of the FCS, not total emissions nationwide. Furthermore, the notifier states that “… emissions from approval of FCN 731 would increase this number by [...]” Since FCN 1223 does not represent any change in environmental effects versus FCN 731, the reference to FCN 731 appears to be a copy and paste error from the confidential attachment to the environmental record for that FCN.
 


 

 
 
Prepared by     __________________________________________Date: October 18, 2012
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: October18, 2012
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