FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
horizontal rule

CFSAN/Office of Food Additive Safety
January 29, 2002

horizontal rule

Environmental Decision Memo
for Food Contact Notification No. 000194

Date; January 29, 2002

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

Subject: FCN No. 194 - Di-tert-amyl peroxide for use as a molecular weight modifier in polypropylene polymers

Notifier: Crompton Corporation
Marshall, Texas 75670

To: Division of Food Contact Substance Notification Review
Attention: Vir Anand
Through: Supervisor, ERG

We have reviewed the claim of categorical exclusion under 21 CFR 25.32(i) for the above referenced notification. It is our understanding that the intended use of the food-contact substance is in polypropylene polymers that will be used entirely as finished food-packaging materials. Therefore, we have concluded that the categorical exclusion is warranted. The claim of categorical exclusion cites the section under which the categorical exclusion is claimed, states compliance with the categorical exclusion criteria, and states 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

horizontal rule
horizontal rule