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CFSAN/Office of Food Additive Safety
July 13, 2006
Date: July 13, 2006
From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 637 - Copolymer of 2,6-xylenol and 2,3,6-trimethylphenol for use as a component in the manufacture of articles intended to contact food.
Notifier: General Electric Company
c/o Keller and Heckman, LLP
Washington, D.C., USA
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 (EA) for FCN 637. When this notification becomes effective, these documents and the notifier's revised EA (in PDF*, 315Kb), dated June 14, 2006, 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.
Katrina E. White, Ph.D.
2 Attachments:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 637
A food contact notification (FCN No. 637), submitted by General Electric Company, to provide for the safe use of a copolymer of 2, 6-xylenol and 2, 3, 6-trimethylphenol for use as a component in the manufacture of articles intended to contact food. The food contact substance is intended to contact all types of food under conditions of use A through H, as described in Table 2 of 21 CFR 176.170(c).
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 the notification, including a revised environmental assessment (in PDF*, 315Kb), dated June 14, 2006, and our supplement to the environmental record.
Prepared by __________________________________________Date: July 13, 2006
Katrina E. White, 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: July 13, 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
This document incorporates by reference the notifier's revised environmental assessment (EA) (in PDF*, 315Kb), dated June 14, 2006.
The purpose of this supplement is to ensure the accuracy and completion of the environmental record to assist the public in understanding the agency's basis for preparing a finding of no significant impact.
Item 7. Fate of Emitted Substances in the Environment.
Under Format Item 7, the EA also states, "No significant quantities of any substance will be added to these water systems upon the proper incineration of the polymer, nor upon its disposal in landfills due to the extremely low levels of aqueous migration of the polymer components." We do not agree completely with this statement. The main reason that the fate of the FCS in the aqueous environment did not need to be addressed is because no significant introductions of substances into the environment were identified under Format Item 6.
Item 9. Use of Resources and Energy
One relevant environmental concern for polymeric packaging is the potential impact it could have on the current recycling of single use beverage bottles. To address this concern, the notifier provided a complete description of the proposed uses of the FCS and cost and technical information on rigid packaging composed of the FCS in a confidential attachment to the notification. This supported the claim that the FCS was unlikely to be used as a replacement of polymers used to make single use beverage bottles that are recycled at high rates. Therefore, no evidence suggests that this FCS is anticipated to replace rigid packaging that is recycled at high rates; we believe that the proposed use of the FCS will not have a significant impact on the use of resources and energy.
Prepared by __________________________________________Date: July 13, 2006
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review
*PDF Readers are available for free from the Adobe Acrobat web site.
