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Environmental Decision Memo for Food Contact Notification No. 000676

Date: November 2, 2006

From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)

Subject: FCN No. 676 - Octyltriethoxysilane (OTES)-modified titanium dioxide where the silane-modified portion of the FCS is no greater than 1.6% by weight for use as a pigment.

Notifier: E. I. du Pont Nemours and Company, Inc.
Wilmington, DE 19805

To: Division of Food Contact Notifications (HFS-275)
Attention: Mark Hepp, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment (EA) for FCN 676. When this notification becomes effective, these documents and the notifier's EA (in PDF, 382Kb), dated October 6, 2006, may be made available to the public, and we will post them on the internet 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.

2 Attachments:

Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 676

 


 

Finding of No Significant Impact

A food contact notification (FCN No. 676), submitted by E. I. du Pont Nemours and Company, Inc., to provide for the safe use of octyltriethoxysilane (OTES)-modified titanium dioxide where the silane-modified portion of the food-contact substance is no greater than 1.6% by weight for use as a pigment in food-contact polymers.

The Environmental Review Group 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, 382Kb), dated October 6, 2006, and our supplement to the environmental record.

Prepared by__________________________________________Date: November 2, 2006
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by__________________________________________Date: November 2, 2006
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group/Supervisor
Division of Chemistry Research and Environmental Review
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. 676

This document incorporates by reference the notifier's environmental assessment (EA (in PDF, 382Kb), dated October 6, 2006.

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

Item 6. Introduction of Substances into the Environment.

The EA states under Item 6, "...no toxic combustion products are expected as a result of the proper incineration of the FCS." Combustion of the food-contact substance (FCS), as combustion of all solid waste, will result in the generation of toxic substances such as carbon monoxide, carbon dioxide, carbon (soot), particulate matter, and hydrocarbons (1). However, we believe that in a properly operating incinerator, such compounds are unlikely to be emitted into the environment at quantities that would significantly alter current emissions from municipal solid waste combustion facilities (1). The FCS is composed of carbon, titanium, silicon, hydrogen, and oxygen, elements that are commonly found in municipal solid waste. The molecular structure of the FCS and the market volume (available in a confidential attachment to the food-contact notification) show that 1) the FCS will make up a very small portion of the total municipal solid waste currently combusted (estimated to be 33 million tons or 14% of 236 million tons in 2003) (2), and 2) the FCS will not significantly alter the emissions from properly operating municipal solid waste combustors (1). Therefore, incineration of the FCS will not cause municipal solid waste combustors to threaten a violation of applicable emissions laws and regulations (40 CFR part 60 and/or relevant state and local laws).

Item 7. Fate of Emitted Substances in the Environment.

The EA states under Item 7, "The products of complete combustion of the FCS are titanium dioxide, SiO2, CO2, and water; the concentrations of these substances in the environment will not be significantly altered by the proper incineration of the FCS in the amounts utilized for food-packaging applications." We agree that the proper incineration of the FCS will not significantly alter current emissions from properly operating incinerators. However, some incomplete combustion will occur and emissions other than those listed are expected (1).

The EA also states under Item 7, "No significant quantities of any substance will be added to these water systems upon the proper incineration of the FCS, nor upon its disposal in landfills due to the extremely low levels of aqueous migration of its components." We do not agree completely with this statement. The main reason that the fate of the FCS in the aqueous environment did not need to be addressed is because no significant introductions of substances into the environment were identified under Format Item 6. Additionally, in general, migration studies on these food-packaging materials, which are performed to demonstrate the of safety polymeric packaging, indicate only low levels of migration of substances from the package into food. This supports the premise that the FCS is unlikely to leach from the food-package into the landfill leachate. Even if small amounts of the FCS migrate into the landfill leachate, it is unlikely they will migrate out of the landfill because of the Environmental Protection Agency's (EPA) regulations governing municipal solid waste landfills. EPA's regulations require new municipal solid-waste landfill units and lateral expansions of existing units to have composite liners and leachate collection systems to prevent leachate from entering ground and surface water, and to have ground-water monitoring systems (see 40 CFR Part 258). Although owners and operators of existing active municipal solid waste landfills that were constructed before October 9, 1993 are not required to retrofit liners and leachate collections systems, they are required to monitor groundwater and to take corrective action as appropriate.

Literature Cited

  1. Sullivan, P. M.; Hallenbeck, W. H.; Brenniman, G. R. Municipal Solid Waste Combustion; University of Illinois at Chicago: Chicago, IL, 1993.
  2. Municipal Solid Waste Generation, Recycling, and Disposal in the United States: Facts and Figures for 2003; EPA530-F-05-003; U. S. Environmental Protection Agency: Washington, D.C., 2005.

Prepared by__________________________________________Date: November 2, 2006
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review


*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.