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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001167

 

September 12, 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: Kenneth McAdams, Ph.D.
 
Subject: FCN No. 1167 – 1H-Azepine-1-carboxamide, hexahydro -2-oxo-N-[3,3,5-trimethyl-5-[[tetrahydro-3,5-bis[(5-isocyanato-1,3,3-trimethylcyclohexyl)methyl]-2,4,6-trioxo-1,3,5-triazin-1(2H)-yl]methyl]cyclohexyl]- (Caprolactam partially blocked IDPI trimer) intended for use as a component of coatings on single-use metal substrates at a maximum concentration of 13.9% (wt. solids), in contact with all food types, and temperature conditions of use A through H.  
 
Notifier: Valspar
 
Attached is the Finding of No Significant Impact (FONSI) for FCN 1167.  This memo supersedes the FONSI prepared May 2, 2012. On August 14, 2012, the notifier’s agent contacted FDA and informed us that confidential information was contained within the body of the EA dated April 13, 2012. The notifier subsequently submitted a revised EA dated August 20, 2012. Confidential information that was present in the EA dated April 13, 2012, has been removed and placed into a confidential attachment to the revised EA. After this notification becomes effective, copies of this FONSI and the notifier's revised environmental assessment, dated August 20, 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. 1167), submitted by Valspar, to provide for the safe use of caprolactam partially blocked IDPI trimer (1H-Azepine-1-carboxamide, hexahydro -2-oxo-N-[3,3,5-trimethyl-5-[[tetrahydro-3,5-bis[(5-isocyanato-1,3,3-trimethylcyclohexyl)methyl]-2,4,6-trioxo-1,3,5-triazin-1(2H)-yl]methyl]cyclohexyl]-) for use as a component of coatings on single-use metal substrates at a maximum concentration of 13.9% (wt. solids), in contact with all food types, and temperature conditions of use A through H.
 
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 August 20, 2012.
EPA guidelines and standards for the prevention of significant deterioration (PSD) review as part of the New Source Review program requiring further modeling and studies are not triggered until there is an increase of 40 tons of NOx per year per project, in an attainment area and 25 to 10 tons/year per project in a serious to extreme non-attainment area. The estimated nationwide production of NO2 in the first year of production of the FCS is confidential but below both thresholds; thus we believe that the potential increases in NO2 produced as a result of this FCN becoming effective for the use of the caprolactam-blocked IPDI Trimer are insignificant.
 
Prepared by     __________________________________________Date: September 12, 2012
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by   __________________________________________Date: September 12, 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