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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. 000679

Date:December 18, 2006
From:Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject:FCN No. 679 - Styrene block polymers with 1,3-butadiene, hydrogenated for single and repeat use as a basic resin in food-contact articles
Notifier:Kraton Polymers LLC
World Houston Building
Houston, TX 77032
To:Division of Food Contact Notifications (HFS-275)
Attention: Ken McAdams
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

The above referenced notification contains two proposed uses for the food contact substance (FCS), in articles or as a component of articles intended to contact food under both single and repeat use conditions. The notifier submitted a claim of categorical exclusion under 21 CFR 25.32(j) for the proposed use of the FCS in articles or as a component of articles intended for repeat use food-contact applications.

We have reviewed the claim of categorical exclusion and have concluded that categorical exclusion is warranted for the proposed use of the FCS in food-contact articles intended for repeated use. The claim of categorical exclusion cites the section under which categorical exclusion is warranted, 21 CFR 25.32(j), states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.

The notifier submitted an environmental assessment (EA) for the proposed use of the FCS in articles or as a component of articles that contact food under single use conditions. The EA was required because as the FCS will comprise greater than 5 percent-by-weight of the finished food contact article.

We have reviewed the EA and have prepared a Finding of No Significant Impact (FONSI) for the proposed use of the FCS in articles or as a component of articles that contact food under single use conditions (attached). After this notification becomes effective, this FONSI and the notifier's environmental assessment (in PDF, 596Kb), dated October 16, 2006, may be made available to the public and we will post them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.*

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

Annette M. McCarthy, Ph.D.

Attachment

 


 

Finding of No Significant Impact

A food contact notification (FCN No. 679), submitted by Kraton Polymer LLC, to provide for the safe use of styrene block polymers with 1,3-butadiene, hydrogenated for single and repeat use as a basic resin in food-contact articles.

The Environmental Review Group has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and therefore will not require the preparation of an environmental impact statement. This finding is based on information submitted by the notifier in an environmental assessment (in PDF, 596Kb) dated October 16, 2006.

Prepared by __________________________________________Date: December 18, 2006
Annette M. McCarthy, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by__________________________________________Date: December 18, 2006
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.