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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000737

Date:June 13, 2007
From:Environmental Toxicologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 737 - Poly[bis(isoindol-2-yl-1,3-dione)-1,3-phenylene-4,4'-(1-methylethylidene)bisphenol] for use as a component of food contact articles.
Notifier:General Electric Company
1 Noryl Avenue
Selkirk, New York 12158
To:Division of Food Contact Notifications (HFS-275)
Attention: Anita Chang, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERT



 

Attached is the Finding of No Significant Impact (FONSI) and our supplement to the environmental record for Food Contact Notification (FCN) 737. After this notification becomes effective, the FONSI and the notifier's environmental assessment (in PDF, 342Kb), dated May 7, 2007, may be made available to the public in response to a FOIA request and we will post redacted copies of 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. 737


 

Finding of No Significant Impact

A food contact notification (FCN No. 737), submitted by General Electric Company, to provide for the safe use of poly[bis(isoindol-2-yl-1,3-dione)-1,3-phenylene-4,4'-(1-methylethylidene)bisphenol] for use as a component of food contact articles.

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 the notification, including an environmental assessment (in PDF, 342Kb), dated May 7, 2007, and our supplement to the environmental record for FCN 737.

Prepared by__________________________________________Date: June 13, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by__________________________________________Date: June 13, 2007
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration



 

 

Supplement to the Environmental Record
For Food Contact Notification No. 737

Note: Material that is not releasable under the Freedom of Information Act (FOIA) has been redacted/deleted from this electronic version of the document. Deletions are marked by a barred out area or hash marks.

This document incorporates by reference the notifier's revised environmental assessment (EA), dated May 7, 2007, and confidential market volume information submitted in Attachment 7. THIS SUPPLEMENT CONTAINS CONFIDENTIAL BUSINESS INFORMATION THAT SHOULD NOT BE RELEASED TO THE PUBLIC.

The purpose of this supplement is to ensure the accuracy and completeness of the environmental record. The information discussed in this supplement was considered in our analysis of the environmental impact and was needed to arrive at a finding of no significant impact (FONSI). Our finding is based on the predicted market volume, which is considered confidential business information. Additionally, information discussed may be subject to exemption under the Freedom of Information Act. Therefore, we decided not to place this document on the web in our Inventory of Environmental Impact Decisions for Effective Food Contact Substances.

Clarification of Information in the EA

Under Format Item 7, the EA 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 understand that the term migration in the EA refers to movement of substances out of the food contact article into food and not to data on the movement of substances out of the food contact article into a landfill or movement of the substance out of a landfill. In general, migration studies or calculations on these food-packaging materials, which are performed to demonstrate the safety of polymeric packaging, indicate only low levels of migration of substances from the food contact article into food. Even if small amounts leach from a package into landfill leachate, the United States Environmental Protection Agency's regulations governing landfills (40 CFR Part 258) will minimize migration of the leachate into the natural environment (1-3). Municipal solid waste (MSW) landfills must comply with the federal regulations in 40 CFR Part 258 or equivalent state regulations. The federal standards include composite liner requirements, leachate collection and removal systems, groundwater monitoring requirements, and closure and post closure care requirements (1-3).


The remaining portion of the supplement contains confidential
business information and was not placed on the web.


*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.