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U.S. Department of Health and Human Services

Food

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Environmental Decision Memo for Food Contact Notification No. 000220

Date: March 18, 2002

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

Subject: FCN No. 220 - Methylmethacrylate trimethylolpropane trimethacrylate copolymers for use as an antiblocking agent in linear low density polyethylene (LLDPE) copolymers

Notifier: Nippon Shokubai Ltd
c/o Keller and Heckman, LLP
Washington, D.C. 20001

To: Division of Food Contact Substance Notification Review (HFS-275)
Attention: Julius Smith
Through: Paul DeLeo, PhD, Environmental Scientist, ERG

We have reviewed the claims of categorical exclusion under 21 CFR 25.32(i) and (j) for the above referenced notification, formerly Food Additive Petition 0B4713. We have concluded that the categorical exclusions are warranted. The notifier's original submission dated December 22, 1999, contained a claim of categorical exclusion under 21 CFR 25.32(i). However, the intended use of the food-contact substance was beyond the scope of this exclusion (finished food-packaging). Subsequently, in an amendment dated February 23, 2002, the notifier claimed an additional categorical exclusion under 21 CFR 25.32(j) to cover repeat use food-contact articles in addition to the exclusion under 21 CFR 25.32(i). We feel that by citing both exclusions the notifier is addressing virtually all applications covered by the intended use. The claims of categorical exclusion cite the section under which each categorical exclusion is claimed, state compliance with the categorical exclusion criteria, and state 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.

Jonathan L. Chappell