• 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. 000617

Date: May 25, 2006

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

Subject: FCN No. 617 - Polyether ester elastomer for use as a component of food contact articles

Notifier: E. I. duPont de Nemours and Co., Inc.,
c/o Keller and Heckman, LLP
Washington, D.C., USA

To: Division of Food Contact Notifications (HFS-275)
Attention: Vanee Komolprasert, Ph.D., P.E.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

The food contact substance for this notification is poly(1, 4-benzene dicarboxylic acid dimethyl ester, 1, 4-butanediol, ethylene oxide, propylene oxide). Attached are the Finding of No Significant Impact (FONSI) and our Supplement to the notifier's Environmental Assessment (EA) for FCN 617. When this notification becomes effective, the following documents may be made available to the public and we will post them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html* after the notification becomes effective:

  1. This FONSI;
  2. The notifier's EA, dated April 20, 2006; and
  3. Our supplement to the record for FCN 617.

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


 

Finding of No Significant Impact

A food contact notification (FCN No. 617), submitted by E. I. duPont de Nemours and Co., Inc., to provide for the safe use of poly(1, 4-benzene dicarboxylic acid dimethyl ester, 1, 4-butanediol, ethylene oxide, propylene oxide) as a component of food contact articles in contact with all food types under conditions of use A-H, as specified in Tables 1 and 2 of 21 CFR 176.170 (c), respectively. The food contact substance will be used at a maximum thickness of 3 mils and will not be used as a component of bottles.

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 a revised environmental assessment dated April 20, 2006 and on information in the FCN.

Prepared by __________________________________________Date: May 25, 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: May 25, 2006
Layla I. Batarseh, Ph.D., Supervisor
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



 



 

 

Supplement to the Environmental Information
for Food Contact Notification No. 617

This document incorporates by reference the notifier's revised environmental assessment (EA) dated April 20, 2006.

The purpose of this supplement is to ensure the accuracy of the environmental record. Comments of the environmental review group to supplement specific format items in the EA are provided below.

Item 5. Identification of Substance that is the Subject of the Proposed Action.

Under Format Item 5, the EA states that the food contact substance (FCS) that is the subject of this Notification is poly(1, 4-benzene dicarboxylic acid dimethyl ester, 1, 4-butanediol, ethylene oxide, propylene oxide). The listed substance is a close representative of the FCS, which contains an extremely small amount of a monomer that is considered confidential.

Item 7. Fate of Emitted Substances in the Environment.

Under Format Item 7, the EA states, "The products of complete combustion of the polymer are carbon dioxide and water; the concentrations of these substances in the environment will not be significantly altered by the proper incineration of the polymer in the amounts utilized for food-contact applications." Although properly operating incinerators substantially reduce the quantity of emissions from waste combustors, they do not completely eliminate them because some incomplete combustion still occurs (Paul M.Sullivan; Hallenbeck, W. H.; Brenniman, G. R. Municpal Solid Waste Combustion; University of Illinois at Chicago: Chicago, IL, 1993). The FCS consists of carbon, hydrogen, oxygen and an extremely small amount of another element present in the confidential monomer of the FCS. Based on the molecular formula of the polymer, the percent of the confidential element in the FCS, and the confidential market estimate, the amount of the confidential element in the FCS 1) will be an extremely small fraction of the total amount of the that element already in municipal solid waste (MSW), and 2) will not result in a significant increase in the amount of emissions released due to the incineration of MSW containing the FCS. Further, combustion of the FCS in incinerators will not affect compliance with the U.S. Environmental Protection Agency regulations for incinerators (40 CFR Part 264). Consequently, emissions released due to the proposed use of the FCS will not significantly affect the quality of the human environment.

Under Format Item 7, the EA states, "No significant quantities of any substance will be added to these water systems upon the proper incineration of the polymer, nor upon its disposal in landfills due to the extremely low levels of aqueous migration of the polymer 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.


*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.