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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000526

Date: June 29, 2005

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

Subject: FCN No. 526 - 1,3-Benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid for use as a component of non-food-contact layers of multilayer films

Notifier: EMS Chemie-AG/ EMS-Chemie Inc.
2060 Corporate Way
Sumter, SC 29151

To: Division of Food Contact Notifications (HFS-275)
Attention: Carol Weaver

Attached are the Finding of No Significant Impact (FONSI) and our Supplement to the notifier's Environmental Assessment (EA) for FCN 526. 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; and
2. The notifier's EA, dated June 2, 2005.

Our SUPPLEMENT to the FCN is CONFIDENTIAL and MUST NOT BE RELEASED.

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

Annette M. McCarthy, Ph.D.

Attachment




Finding of No Significant Impact

A food contact notification (FCN No. 526), submitted by EMS-Chemie AG/ EMS-Chemie (North America) Inc., to provide for the safe use of 1,3-Benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid for use as a component of non-food-contact layers of coextruded multilayer films for food packaging.

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 an environmental assessment dated June 2, 2005, and on confidential information submitted by the notifier and contained in our supplement to the record.

Prepared by__________________________________________Date: June 29, 2005
Annette M. McCarthy, 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: June 29, 2005
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. 526

Note: Material that is not releasable under the Electronic Freedom of Information Act (EFOIA) has been redacted/deleted from this electronic version of the document. Deletions are marked by a barred out area or hash marks.


This document incorporates by reference the notifier's environmental assessment (EA) dated June 2, 2005, and confidential market volume contained in an attachment to the Food Contact Notification. This supplement SHOULD NOT be released to the public.

Estimate of the amount of nitrogen oxide resulting from the proper incineration of food-packaging articles containing 1,3-Benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid.

The FCS contains nitrogen that upon incineration will form nitrogen oxides. These gases have the potential to cause adverse environmental effects by contributing to acid precipitation. We estimated the amount of nitrogen oxide that could be emitted upon incineration of the food contact articles containing the FCS using confidential information provided by the notifier. In an e-mail message sent April 20, 2005, the notifier said that the five-years market volume estimate of the FCS is | | | | | | | | | | | | | | | | |. Our estimate of the maximum percent of the molecular weight of the FCS that is nitrogen is | | | | | | | |. The amount of nitrogen produced is calculated as:

Nproduced = maximum yearly market volume x incineration rate x fraction N in FCS

Nproduced= | | | | | x 0.24 x | | | | | | | | = | | | | | | | metric tons

The amount of nitrogen oxide produced is:

NO2produced=Nproduced x 46/14

NO2produced= | | | | | | | x 46/14= | | | | | | | metric tons

The estimated amount of nitrogen oxide that could be emitted as a result of incinerating municipal solid waste containing the FCS would be an extremely small fraction of the total nitrogen oxides emitted from anthropogenic sources, which was estimated to be 18.8 million tons (17.1 million metric tons) in 2004 (United States Environmental Protection Agency, 2004, Air Emissions Trends- Continued Progress Through 2004).


*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.