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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. 000513

Date: July 5, 2005

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

FCN No. 513 - A mixture of 2-hydroxy-2-sulfinatoacetic acid, disodium salt, 2-hydroxy-2-sulfonatoacetic acid, disodium salt and sodium sulfite

Notifier: Bruggemann Chemicals US, Inc.
15 Reese Avenue, Suite 200
Newton Square, PA 19073

To: Division of Food Contact Notifications (HFS-275)
Attention: Ken McAdams, Ph.D.

We have reviewed the claim of categorical exclusion for the above referenced notification and have concluded that categorical exclusion is warranted. The FCS is intended for use as a reducing agent in emulsion polymerization redox catalyst systems for the manufacture of food-contact polymers used in food-contact paper and paperboard, adhesives and in rubber articles intended for repeat use at a maximum use level of 1%. At least 95% of the total market volume of the FCS and its oxidation products will remain in the finished food packaging material. The claim of categorical exclusion cites the section under which categorical exclusion is warranted, 21 CFR 25.32 (i), states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.

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

Annette M. McCarthy, Ph.D.