FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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CFSAN/Office of Food Additive Safety
January 16, 2002

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Environmental Decision Memo
for Food Contact Notification No. 000192

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.

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