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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001268

 

Date: April 22, 2013
 
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1268 – 1H-Azepine-1-carboxamide, N,N’,N’’-[(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)tris[methylene(3,5,5-trimethyl-3, 1-cyclohexanediyl)]]tris[hexahydro-2-oxo-]; Vestanat ® B1186/100; [CAS No. 68975-83-7]. The FCS is also known as caprolactam blocked isophorone diisocyanate (IPDI) trimer intended for use as a reactant with one or more of the polybasic acids or polyhydric alcohols in the formation of coatings on metal substrates in single use food-contact applications and any suitable substrate in repeated-use food-contact applications, complying with 21 CFR 175.300(b)(3)(vii) , in contact with all food types under Conditions of Use A through H.
Notifier: Evonik Industries AG
 
To: Anita Chang, 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 1268. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated April 3, 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.
 
 
 
Mariellen Pfeil
 
 
 
 
 
Attachment:    Finding of No Significant Impact
 
               cc:     HFS-255 Pfeil
             File:     FCN No. 1268


 

FINDING OF NO SIGNIFICANT IMPACT
 
A food-contact notification (FCN No. 1268), submitted by Evonik Industries AG, to provide for the safe use of 1H-Azepine-1-carboxamide, N,N’,N’’-[(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)tris[methylene(3,5,5-trimethyl-3, 1-cyclohexanediyl)]]tris[hexahydro-2-oxo-], asa reactant with one or more of the polybasic acids or polyhydric alcohols in the formation of coatings on metal substrates in single use food-contact applications and any suitable substrate in repeated-use food-contact applications, complying with 21 CFR 175.300(b)(3)(vii), in contact with all food types under 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 (EA), dated April 3, 2013, confidential environmental assessment support information attached to the EA, and chemistry attachments to the notification, as summarized below.
The potential for environmental impact posed by use of the food contact substance (FCS) is predominantly from release of the caprolactam blocking agent during the curing process of the polymer coating. When cured, caprolactam releases oxides of nitrogen (NOx). The environmental concentrations for NOx, expressed in the calculations as NO2, based on 5th production year predicted market values of this notified use are within acceptable potential to emit (PTE)[1] amounts when evaluated per U.S. EPA guidelines and standards for the prevention of significant deterioration (PSD) review. This review, pursuant to the Clean Air Act and the New Source Review Program, triggers further modeling and emission studies when there is an increase of 40, 25, and 10 tons of NOx per year per project in attainment, serious non-attainment, and extreme non-attainment areas, respectively. These thresholds would be met in light of the fact that the formulated coatings will be manufactured across multiple facilities, nationwide, and that the calculation is exaggerative of potential NOx release at any given site. Further, the FCS is intended as a replacement for substances already on the market, therefore, no substantive net increase in NOx emissions are expected. It is additionally noted that emissions can and will likely be reduced by existing effluent control measures at FCS coating facilities operating in compliance with U.S. EPA regulations.
Maximum percent residuals for FCS impurities and components that are present in and may migrate from the finished food-contact articles during use and disposal are confidential but the total is less than 5%wt. of the FCS. Once coated and cured, the FCS is stable under the conditions of use and no significant degradation is expected. Because the intended use of the FCS is intended to replace that cleared in a prior effective food contact notification, no new exposure to the FCS is expected.
Articles containing the FCS are expected to replace, and be disposed of at a rate equivalent to, products with similar use profiles already on the market. The use and disposal of the FCS is not expected to threaten violation of applicable laws and regulations (e.g. U.S. EPA 40 CFR parts 60 and 258).
To assess the potential impacts of the disposal, we reviewed statistics from EPA’s 2011 Municipal Solid Waste (MSW) Report.[2]  According to this report, of the total of 249.8 million tons of municipal solid waste (MSW) generated in 2010,
            135.7 million tons (54.3%) were land disposed,
              64.8 million tons (25.9%) recovered for recycling,
                       steel and aluminum cans constituting 25.4% (16.5 million tons),
              29.3 million tons (11.7%) combusted, and
              20.2 million tons (8.75%) composted
Land disposal and recycling are expected to be the primary routes of introduction into the environment for products coated with the FCS. FCS disposal via these routes amount to less than 1/1000th percent of the total generated MSW. As such, significant releases to the environment from land disposal and recycling are not expected presuming disposal in accordance with U.S. EPA regulations in 40 CFR parts 60 and 258. Similarly, inputs are not expected to alter emissions from permitted MSW incineration facilities.
 
 
 
Prepared by          __________________________________________Date: April 22, 2013
Mariellen Pfeil
Biologist
Office of Food Additive Safety           
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by          __________________________________________Date: April 22, 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] PTE refers to the highest amount of a pollutant that could be released into the air by a single facility. It is calculated based on production equipment capacity and maximum hours of operation in a 365 day year.
[2] 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.