• 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. 000563

Date: May 24, 2006

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

Subject: FCN No. 563 - Dimethyl sulfoisophthalate, sodium salt modifier in polyethylene phthalate polymers blended with poly(m-xylylene adipamide) nylon for bottles.

Notifier: Wellman, Inc.
1041 521 Corporate Center Drive
Fort Mill, SC 29715

To: Division of Food Contact Notifications (HFS-275)
Attention: Vivian Gilliam
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 563. The FCS is 1, 3-benzenedicarboxylic acid, 5 sulfo , 1, 3-dimethyl ester, sodium salt. When this notification becomes effective, these documents and the notifier's EA, dated December 29, 2005, 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.*

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

William H. Lamont

2 Attachments:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 563



 



 

Finding of No Significant Impact

A food contact notification (FCN No. 563), submitted by Wellman, Inc., to provide for the safe use of dimethyl sulfoisophthalate, sodium salt, at a maximum level of 1 mole percent based on total diacids (diesters), or 0.5 mole percent based on the finished polyethylene terephthalate, where the modified polyethylene terephthalate may be blended with a hexanedioic acid polymer with 1,3 benzenedimethanamine (MXD 6) at a level not to exceed 30 percent by weight of the polyethylene terephthalate, for fabrication of bottles intended to contact food.

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 December 29, 2005, and our supplement to that EA.

Prepared by __________________________________________Date: May 24, 2006
William H. Lamont, Chemist
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 24, 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. 563

This document incorporates by reference the notifier's environmental assessment (EA) dated December 29, 2005.

The FCS contains sulfur, which will form oxides of sulfur (SOx) upon incineration. Emissions of SOx have the potential to cause adverse environmental effects by contributing to acid rain. Data available to the agency-including public information, confidential information in the submission, and information the agency has received in other submissions for the same or similar substances-support a conclusion that the potentially emitted amount of SOx from incineration of food contact articles containing the FCS would be a small fraction of the total SOx emitted from combustion of municipal solid waste. Therefore, the potential emission of SOx from incineration of disposed food contact articles containing the FCS does not threaten a violation of Federal, State, or local law or requirements imposed for the protection of the environment.

Prepared by ___________________________________________ Date: May 24, 2006
William H Lamont, Chemist
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.