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Environmental Decision Memo for Food Contact Notification No. 000405

Date: March 15, 2004

 

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

 

Subject: FCN No. 405 - Ethylene-2-norbornene copolymer as a basic polymer used in the production of articles intended to contact food

 

Notifier: Ticona
86 Morris Avenue
Summit, NJ 23234

 

To: Division of Food Contact Notifications (HFS-275)
Attention: Elizabeth R. Sanchez, Ph.D.
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 405. When this notification becomes effective, these documents and the notifier's EA, dated January 15, 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.

 

 

 

Tong Zhou, Ph.D.

 

2 Attachments

 

 





Finding of No Significant Impact

A food contact notification (FCN No. 405), submitted by Ticona, to provide for the safe use of ethylene-2-norbornene copolymer (density 1.02 ± 0.04 g/cm3), containing not less than 20 but no more than 70 mole percent of polymer units derived from norbornene, as a basic polymer used in the production of articles 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 January 15, 2004, and on our supplement to that EA.

 

Prepared by ___________________________________________ Date: March 15, 2004
Tong Zhou, 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: March 15, 2004
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. 405

This document incorporates by reference the notifier's environmental assessment (EA) dated January 15, 2004.

 

The notifier, Ticona, stated in the EA that polymers currently used in the applications in which the FCS is anticipated to be used include high density polyethylene (HDPE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), polypropylene (PP) and possibly polyethylene terephthalate (PET film only). However, it is not expected to be used as a replacement for PET soda bottles or HDPE milk bottles. The notifier indicated in an email, dated February 16, 2004, that the principle application of the FCS will be in 50 ml alcohol mixture drinks, which are rarely recycled; the notifier also is considering the use of the FCS in infant feeding bottles, which are not recycled.

Format Item 9: Use of Resources and Energy

We believe that the proposed use of the subject FCS will not have significant impacts on solid waste management practices for the following reasons:

(1) This material would not be compatible with applications where PET is used in carbonated soft drink bottles because it does not have sufficient gas permeability for such use;

(2) The notifier says that the FCS is much more expensive than either PET or HDPE; therefore, it is not expected to replace PET soda bottles or HDPE milk bottles. For this reason, it is expected, to be used in specialty bottles mostly, as indicated in the notifier email dated February 16, 2004;

(3) The predicated market volume for the subject FCS (including the use in non-bottle applications) is a very small fraction of the total market volume of both PET and HDPE used for bottles. Thus, the likelihood this material will contaminate and be a problem for recycling streams is small because any contamination will result in extremely small percentage in the recycling streams of both materials;

(4) Accidental contamination is not expected to pose problems for PET recycling. The FCS has a density of 1 ± 0.04 g/cm3; therefore, it could be easily separated from PET (density = 1.35 g/cm3) in a float density separation after shredding at the beginning of the recycling process.

(5) The FCS has melting properties that are not compatible with polyethylenes LDPE and PP. However, we do not expect the FCS to significantly affect the overall material and energy use as a result of affecting the recycling of polyethylene packaging since less than 1% of plastic bottles recycled are LDPE/LLDPE and PP.

Conclusion

Based on the above discussion and on the EA, we believe that the proposed use of the subject FCS will not have any significant impacts on recycling, and thus will not have any impact on the use of natural resources and energy.

 

 

 

 

Prepared by___________________________________________ Date: March 15, 2004
Tong Zhou, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review