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CFSAN/Office of Food Additive Safety
January 16, 2002
Date: January 16, 2002
From: Environmental Scientist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review
Subject: FCN No. 192 - 12H-Dibenzo[d,g][1,3,2]dioxaphosphocin,2,4,8,10-tetrakis(1,1-dimethylethyl)-6-[(2-ethylhexyl)oxy]- for use as an antioxidant and/or a stabilizer in rubber modified polystyrene
Notifier: Asahi Denka Kogyo K.K.
c/o Japan Tech. Info. Ctr.
Arlington, VA 22202
To: Division of Food Contact Substance Notification Review
Attention: Kelly Randolph
Through: ERG Reviewer
We have reviewed the claim of categorical exclusion under 21 CFR 25.32(i) for the above referenced notification and 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. It is our understanding that the limitations described in the December 7, 2001 acknowledgment letter to the Notifier will effectively result in the food contact substance being used exclusively in finished food-packaging materials.
Please let us know if there is any change in the identity or use of the food-contact substance.
Paul C. DeLeo, Ph.D.