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CFSAN/Office of Food Additive Safety
March 4, 2002
Date: March 4, 2002
From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 199 - Imidazolium compounds for use as a debonding agent in uncoated paper for use in contact with food
Notifier: Hercules Incorporated
c/o Keller and Heckman LLP
Washington, DC 20001
To: Division of Food Contact Substance Notification Review (HFS-275)
Attention: Vivian Gilliam
Through: Paul DeLeo, Environmental Scientist, ERG
We have reviewed the claim of categorical exclusion under 21 CFR 25.32(i) for the above referenced notification. Based on the notifier's letters, dated January 31, 2002 and February 8, 2002; a teleconference with the notifier on February 13, 2002; and the notifier=s email, dated February 19, 2002, we have concluded that the categorical exclusion is warranted. Specifically, the notifier demonstrated that the food contact substance (FCS), when added at the wet end of the papermaking process, will partition entirely with the paper fiber such that there is essentially no release of the FCS into the environment during the manufacture, use or disposal of the paper and paperboard. Subsequently, we have concluded that the notification meets the categorical exclusion criteria cited under 21 CFR 25.32(i) of being "present in finished food-packaging material at not greater than five percent-by-weight" and remaining "with finished food-packaging material through use by consumers."
In addition, the notifier's claim of categorical exclusion cites the section under which the categorical exclusion is claimed, states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment. Therefore, 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.
Tong Zhou, Ph.D.
