• 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. 000085

Date: September 22, 2000

 

From: Environmental Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)

 

Subject: FCN No. 85 - Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified)

 

Notifier: Coalition on PET Safety

 

To: Division of Petition Control (HFS-215)
Attention: Mark Hepp
Through: Team Leader, ERT (HFS-246)

 

Attached are the Finding of No Significant Impact (FONSI) for this premarket notification and a supplemental environmental assessment (EA) we prepared. When this notification becomes effective, the FONSI, the notifier's July 24, 2000, EA, and our supplemental EA may be made available to the public. If the environmental documents are made public, be sure to include the attachment to the notifier's EA entitled "Plastic Pellets in the Aquatic Environment: Sources and Recommendations."

 

Please let us know if there is any change in the identity or use of the food-contact substance that would be inconsistent with the identity and use described in the FONSI.

 

 

Elizabeth Ann Cox

 

2 Attachments
FONSI
Supplemental EA

 

 



 



 

 

Finding of No Significant Impact

Premarket notification FCN No. 85, submitted by the Coalition on PET Safety representing Eastman Chemical Company, E.I. duPont de Nemours & Co., Shell Chemical Company, Wellman, Inc., KoSa, to provide for the safe use of polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) as films or articles intended for contact with all types of food.

 

The Environmental Review Team 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 July 24, 2000 and on the attached supplement to the environmental assessment prepared by the Environmental Review Team.

 

 

Prepared by: _______________________________________ Date: September 22, 2000
Elizabeth Ann Cox, Environmental Chemist
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 

Approved by:______________________________________ Date: September 22, 2000
Buzz L. Hoffmann, Ph.D., Team Leader
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 



 



 

 

Supplement to the Environmental Information
for Food Contact Notification No. 85

This document incorporates by reference the notifier's environmental assessment (EA) dated July 24, 2000 and its attachment.

 

In the environmental assessment (EA) for this notification, the notifier describes a study on environmental concerns with the release of plastic pellets into the aquatic environment, see page 10. This study, entitled Plastic Pellets in the Aquatic Environment: Sources and Recommendations, is attached to the EA. The notifier says that pellets made from the subject copolyesters may be released into the aquatic environment but do not present any special concern because the pellets will sink in water and not be readily accessible. This conclusion by the notifier is applicable to the potential for effects on organisms that feed in the water column. However, it is not applicable to bottom-feeding organisms. Pellets that sink in water and come to rest on the bottom may be accessible to these organisms. Still, there is little or no potential for significant adverse environmental effects as a result of this action because there should be little or no change in the levels of pellets released. Little or no change is expected because articles made with the subject copolyesters will be competing with and replacing articles made from very similar, currently permitted polymeric materials. That is, the factors that operate to cause the release of pellets into the environment will not change when the subject copolyesters replace currently used materials.

 

 

 

Prepared by:_______________________________________ Date: September 22, 2000
Elizabeth Ann Cox, Environmental Chemist
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration