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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000417

Date: May 10, 2004

 

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

 

Subject: FCN No. 417 - 1,3-benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,6-hexanediamine and 4,4'-methylenebis[2-methylcyclohexanamine]

 

Notifier: ES-Chemie AG/EMS
Chemie (North America) Inc.
Sumter, SC 29151-1717

 

To: Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams
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 for FCN 417. When this notification becomes effective, these documents and the notifier's environmental assessment, dated March 29, 2004, may be made available to the public.

 

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

 

 

 

Jonathan L. Chappell

 

2 Attachments:
Finding of No Significant Impact
Supplement to the Environmental Assessment for FCN 417

 

 





Finding of No Significant Impact

A food contact notification (FCN No. 417), submitted by EMS-Chemie AG/EMS Chemie (North America) Inc., to provide for the safe use of 1,3-benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,6-hexanediamine and 4,4'-methylenebis[2-methylcyclohexanamine] as a component of non-food-contact layers of multilayer films.

 

 

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 (EA) dated March 29, 2004 and on our supplement to that EA.

 

 

 

Prepared by ______________________________________________________ Date: May 7, 2004
Jonathan L. Chappell, Environmental Scientist
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:
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. 417

This document incorporates by reference the notifier's environmental assessment (EA) dated March 29, 2004.

 

 

Footnote 2 of the notifier's EA states, "This expectation is confirmed by the results of extraction studies described in Attachment 8 of the FCN...there were no detectable levels of either the polymer or the monomers from which the polymer is manufactured using analytical methods with a detection limit of parts per billion (ppb)." The migration results in Attachment 8 actually reported a detection limit of 50 parts per billion. This error in the notifier's EA does not affect our environmental impact conclusion, but it should be noted in order for information in the EA to be consistent with information elsewhere in the notification.

 

 

 

Prepared by_______________________________________ Date: May 7, 2004
Jonathan L. Chappell, Environmental Scientist
Environmental Review Group
Division of Chemistry Research and Environmental Review