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U.S. Department of Health and Human Services


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Environmental Decision Memo for Food Contact Notification No. 000123

Date: April 2, 2001


From: Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)


Subject: FCN No. 123 - Polyester-epoxy Urethane Adhesive Formulations


Notifier: Toyo-Morton, Limited
c/o Keller and Heckman
Washington, DC


To: Division of Petition Control (HFS-215)
Attention: Julius Smith
Through: Acting Team Leader, ERT (HFS-246)



On December 11, 2000, Keller and Heckman requested that FAP 7B4538 be converted to a food contact notification (FCN), which OPA has subsequently done. The environmental review of FAP 7B4538 is summarized in our November 24, 1997, memorandum (attached) on that petition. In that memorandum we concluded that the categorical exclusion claimed by the petitioner was warranted.


The environmental review of the types of substances and uses of such substances that fall under the categorical exclusion in 21 CFR 25.32(i) is the same whether a sponsor submits a food additive petition or an FCN. Therefore, the categorical exclusion in 21 CFR 25.32(i) that was warranted for the petition is also warranted for this FCN and neither an environmental assessment nor an environmental impact statement is required.


Please let us know if there is any change in the identity or use of the food-contact substance that would render the categorical exclusion inappropriate.




John L. Dennison