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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000222

Date: April 23, 2002

 

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

 

Subject: FCN No. 222 - 1,5-Cyclooctadiene Used to Manufacture Polybutadiene Rubber to Increase Impact Strength

 

Notifier: UBE Industries, Ltd.
c/o Center for Regulatory Services
Woodbridge, VA 22192

 

To: Division of Food Contact Substance Notification Review (HFS-275)
Attention: Kelly Randolph, D.V.M.
Through: Layla I. Batarseh, Supervisor, ERG

 

 

Attached is the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment (EA) for this premarket notification. When this notification becomes effective, the following documents may be made available to the public:

 

1. The FONSI;
2. The notifier's October 29, 2001, EA; and
3. Our supplement to the EA except for our confidential calculations.

 

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.

 

 

 

Jonathan L. Chappell

 

2 Attachments
1) Finding of No Significant Impact
2) Supplement to the Environmental Assessment for Food Contact Notification No. 222

 

 





Finding of No Significant Impact

A food contact notification (FCN No. 222), submitted by UBE Industries, Ltd., to provide for the safe use of 1,5-cyclooctadiene used to manufacture polybutadiene rubber to increase impact strength.

 

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 October 29, 2001, and on information contained in our supplement to that EA.

 

 

 

Prepared by____________________________________________ Date: April 8, 2002
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: April 8, 2002
Layla 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. 222

This document incorporates by reference the notifier's environmental assessment (EA) dated October 29, 2001, and submissions from the notifier dated February 25, 27, and 28, 2002.

 

Most of the environmental issues associated with this Food Contact Notification (FCN) are addressed in the notifier's EA. However, the following points require further clarification:

 

1. In addition to releases into water, as discussed in Format Items 7 and 8, extremely small amounts of cyclooctadiene (COD) are also released into other compartments of the environment.

 

2. The notifier stated in a submission dated February 25, 2002, that polybutadiene rubber (BR) can be manufactured without COD. In order to estimate the increased use of resources and energy that might result from using COD to manufacture BR, we calculated the increased use of COD that might result from the notifier's requested action based on the notifier's confidential market volume information. Our calculation is in a separate, confidential section of FCN 222 because it is based on the notifier's confidential business information. We calculate that there will not be a significant increase in the use of COD as a result of this action. Subsequently, no significant increase in the use of resources and energy should result from the action.

 

 

 

 

Prepared by______________________________________________ Date: April 8, 2002
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: April 8, 2002
Layla 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