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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000689

Date:January 19, 2007
From:Chemist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject:FCN No. 689 - 1,4-benzenedicarboxylic acid polymer with 1,4-cyclohexanedimethanol and 1,2-ethanediol (CAS Reg. No. 25038-91-9).
Notifier:SK Chemicals
600 Jungja-1-dong, Changan-ku, Suwon-si
Kyungki-do 440-745, Republic of Korea
To:Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

Attached is the Finding of No Significant Impact (FONSI) for FCN 689. After this notification becomes effective, this FONSI and the notifier's environmental assessment (in PDF, 1.33Mb), dated November 9, 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.*

The notifier's environmental assessment (EA) declared that its preparation conformed to a format specified at 21 CFR 25.31a(b)(1). However, the regulation has been subsequently amended. Before FDA amended part 25, the regulations provided standard EA formats for various classes of actions. After consulting the Council on Environmental Quality (CEQ), FDA decided that sample formats for preparing EAs should be provided in guidance documents rather than in the amended rule. Recommended formats for actions requiring an EA are provided in the current guidance document, which can be found at http://www.cfsan.fda.gov/~dms/opa2eg.html.*

Please let us know if there is any change in the identity or use of the food contact substance.

William H. Lamont

Attachment:
Finding of No Significant Impact


 

Finding of No Significant Impact

A food contact notification (FCN No. 689), submitted by SK Chemicals, to provide for the safe use of 1,4-benzenedicarboxylic acid polymer with 1,4-cyclohexanedimethanol and 1,2-ethanediol (CAS Reg. No. 25038-91-9), with 1,4-cyclohexanedimethanol (consisting of 70 percent trans isomer and 30 percent cis isomer) representing 35 to 80 mole percent of the diol units and 1,2-ethanediol representing 65 to 20 mole percent of the diol units, as articles or component 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) (in PDF, 1.33Mb), dated November 9, 2006, confidential business information, and other information known to the agency.

Prepared by__________________________________________Date: January 19, 2007
William H. Lamont, Chemist
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: January 19, 2007
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


*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.