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U.S. Department of Health and Human Services


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Environmental Decision Memo for Food Contact Notification No. 000208

Date: February 26, 2002


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


Subject: FCN No. 208 - Acetic acid ethenyl ester, polymer with ethanol and dimethyl maleate as a stabilizer in the suspension polymerization of polyvinyl chloride (PVC)


Notifier: Harlow Chemical Co., Ltd.
Central Road, Templefields, Harlow


To: Division of Food Contact Substance Notification Review (HFS-275)
Attention: Parvin Yasaei (HFS-215)
Through: Supervisor, ERG



We have reviewed the claim of categorical exclusion under 21 CFR 25.32(i) for the above referenced notification that the notifier submitted in their amendment dated January 24, 2002. We have concluded that the categorical exclusion is warranted. The claim of categorical exclusion cites the section under which the categorical exclusion is claimed, includes a statement of compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require submission of an environmental assessment. Therefore, neither an environmental assessment nor an environmental impact statement is required. In addition, by virtue of a response in a letter dated January 24, 2002, the notifier concurred with our conclusions that


1) the food contact substance (FCS) will be a substitute for existing stabilizers used in PVC food-contact articles and will not result in a substantial increase in the total market volume of PVC food-contact articles; and


2) the marketing of the FCS will not result in a substantial increase in the total market volume of PVC bottles.


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




Paul C. DeLeo, Ph.D.