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Environmental Decision Memo for Food Contact Notification No. 000716

Date:July 16, 2007
From:Environmental Toxicologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 716 - Titanium nitride for use as an additive in food-contact polyethylene terephthalate (PET) bottles
Notifier:ColorMatrix Group Inc.
Knowsley Merseyside L34 9GT
UNITED KINGDOM
To:Division of Food Contact Notifications (HFS-275)
Attention: Vanee Komolprasert, Ph.D., P.E.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERT



 

The original submission requested the safe use of titanium nitride for use as an additive in single use food-contact PET bottles. The intended use was subsequently amended to allow for use of the additive in single and repeat use PET bottles. This change in the intended use did not affect the environmental impact or review for this food contact notification because the impact as a result of repeat use is minor and subsumed in the impact from single use. This revised finding of no significant impact (FONSI) documents the change in the proposed use and that the FONSI still applies with the change in the intended use.

Attached is the Revised Finding of No Significant Impact (FONSI) for Food Contact Notification (FCN) 716. After this notification becomes effective, these documents and the notifier's environmental assessment (in PDF, 3.23Mb), dated May 2, 2007, may be made available to the public in response to a FOIA request and we will post redacted copies of them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.*

Please let us know if there is any change in the identity or use of the food-contact substance.

Katrina E. White, Ph.D.

Attachment:
Revised Finding of No Significant Impact


 

Revised Finding of No Significant Impact

A food contact notification (FCN No. 716), submitted by ColorMatrix Group Inc., to provide for the safe use of titanium nitride for use as an additive in food-contact polyethylene terephthalate (PET) bottles.

The Environmental Review Team 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 the notification, including an environmental assessment (in PDF, 3.23Mb), dated May 2, 2007, and our supplement to the environmental record for FCN 716.

Prepared by__________________________________________Date: July 16, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by__________________________________________Date: July 16, 2007
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration



 

 

Supplement to the Environmental Record
for Food Contact Notification No. 716

Note: Material that is not releasable under the Freedom of Information Act (FOIA) has been redacted/deleted from this electronic version of the document. Deletions are marked by a barred out area or hash marks. This document was attached to the original FONSI dated June 13, 2007

This document incorporates by reference the notifier's revised environmental assessment (EA) (in PDF, 3.23Mb), dated May 2, 2007. This supplement contains confidential business information that SHOULD NOT be released to the public.

The purpose of this supplement is to ensure the accuracy and completeness of the environmental record and to assist the public in understanding the agency's basis for preparing a finding of no significant impact (FONSI).

Clarification of Information in the EA

The author of the journal article referenced in Footnote 7 should be S. Kaskel instead of S. Kasel.

Confidential Business Information

Normally, confidential business information (CBI) is placed in a confidential attachment to the EA and summarized, to the extent possible, in the EA. All CBI was placed in the EA for this notification. We redacted the information from the EA published on the web and have summarized it here when needed.

The redacted paragraph on Page 9 states the estimated fifth year production estimate.

The redacted paragraph at the bottom of Page 10 compares the use of the FCS to a substance it may compete with.

The redacted section at the end of the second paragraph on Page 11 further discusses the FCS and the recycling process of polyethylene terephthalate.

Nitrogen Oxide Emissions

The food contact substance (FCS) contains nitrogen. Combustion of municipal solid waste (MSW) containing nitrogen has the potential to produce nitrogen oxides (NOx) which can cause adverse environmental effects by contributing to acid precipitation (1). We estimated potential nitrogen dioxide (NO2) emissions produced from combustion of the food contact substance (FCS) and compared that to the amount of NOx emissions from large municipal waste combustion (MWC) units.

NO2 emissions = A × B × C × D

Where:
A = Market Volume of FCS in pounds
B = Percent nitrogen in FCS
C = 3.28 lb NO2/lb nitrogen
D = Percent MSW that is combusted (roughly 13.6 %)1

A = | | | | | estimated by notifier in the EA

| | | | | x 2204.62 lbs/metric ton = | | | | | lbs

B = 23 % Nitrogen in FCS2

| | | | | x 0.23 lb N/lb FCS x 3.28 lb NO2/lb N x 0.136 = | | | | | NO2 emissions

| | | | | x 0.0005 short tons/lb = | | | | | short tons NO2 emissions

Estimated NO2 emissions in U.S. from the FCS = | | | | |

In 2000, NOx emissions from large MWC units were 46,500 short tons/yr (3). The emissions from approval of FCN 716 would increase this number by | | | | | (| | | | | NOx /46,500 short tons/yr x 100 = | | | | | ). The estimated amount of NO2 that could be emitted as a result of incinerating municipal solid waste containing the FCS would be a very small fraction of the total nitrogen oxides emitted from large MWC units. Based on the above analysis, we determined that approval of FCN 716 will not result in a significant increase in current NOx emissions.

Literature Cited

1. Combustion Modification Control of Nitrogen Oxides; EPA/600/F-95-012; U. S. Environmental Protection Agency; Office of Research and Development, National Risk Management Research Laboratory: Research Triangle Park, NC, Aug, 1995. http://www.epa.gov/appcdwww/aptb/pia.pdf (accessed May 14, 2007).

2. Municipal Solid Waste in the United States: 2005 Facts and Figures; EPA530-R-06-011; U.S. Environmental Protection Agency; Office of Solid Waste: Washington, D.C., Oct, 2006. http://www.epa.gov/msw/msw99.htm (accessed Feb. 8, 2007).

3. Stevenson, W. Memorandum to Docket A-90-45; Document ID EPA-HQ-OAR-2003-0072-0017; Jun 20, 2002.

Prepared by __________________________________________Date: June 13, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety


1 In 2005, 54.3% of all MSW in the United States was deposited in land disposal sites, 13.6% was combusted with energy recovery, and 32.1% was recovered for composting and recycling (2). We note that the some of the 54.3% that is land disposed may be incinerated without energy recovery.

2Atomic Weight N divided by (Atomic Weight Ti + Atomic Weight N) x 100 or 14/(14+47.88) x 100 = 22.63 %


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.