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U.S. Department of Health and Human Services


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Environmental Decision Memo for Food Contact Notification No. 000448

Date: August 11 2004


From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)


Subject: FCN No. 448 - Polyester-polyurethane resin as an adhesive in laminate structures that are intended for use at retort temperatures


Notifier: Nippon Kasei Chemical Co., Ltd. and
Rock Paint Co, Ltd.


To: Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG



We have reviewed the claim of categorical exclusion for the above referenced notification and have concluded that categorical exclusion is warranted. The claim of categorical exclusion cites the section under which categorical exclusion is warranted, 21 CFR 25.32(i), states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.


The notifier had mistakenly identified the categorical exclusion as 21 CFR 25.31(i) in its original submission. This mistake was corrected in a letter from the notifier to the agency dated July 23, 2004, which correctly identifies the exclusion as 21 CFR 25.32(i).


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




Annette M. McCarthy, Ph.D.