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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001023

Date:November 18, 2010
From:Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 1023 – Calcium hypochlorite as an antimicrobial in water used to process fruits, vegetables, nuts, meat and poultry and in pretreatment of water used in manufacture of beverages bottled for drinking.
Notifier:PPG Industries, Inc.
19 South, One PPG Place
Pittsburgh, PA 15272
To:Division of Food Contact Notifications (HFS-275)
Attention: Helen Hc C Lee, Ph.D.
Through: William H Lamont, Acting Supervisor, ERT

For requested uses that are substantially the same as uses registered by the Environmental Protection Agency under the Federal Insecticide, Fungicide, and Rodenticide Act, we have reviewed the claim of categorical exclusion for the above referenced notification and have concluded that categorical exclusion is warranted. The claim of categorical exclusion cites the section, 21 CFR 25.32 (q), under which the categorical exclusion is warranted, states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.

For remaining requested uses, attached are the Finding of No Significant Impact (FONSI) and our supplement to the environmental record for FCN 1023. After this notification becomes effective, copies of the FONSI, the notifier's environmental assessment, dated October 22, 2010, and the supplement to the environmental record may be made available to the public. We shall post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.

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

 

Leah D. Proffitt

 

Attachments:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 1023


Finding of No Significant Impact

A food contact notification (FCN No. 1023), submitted by PPG Industries, Inc., to provide for the safe use of calcium hypochlorite as an antimicrobial in water used to process fruits, vegetables, nuts, meat and poultry and in the pretreatment of water used in the manufacture of beverages subsequently bottled for drinking.

The Environmental Review Team 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, dated September 9, 2010, and other information known to the agency.

 

Prepared by __________________________________________Date: November 18, 2010
Leah D. Proffitt
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: November 18, 2010
William H. Lamont, Chemist
Acting Supervisor, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


Supplement to the Environmental Record for Food Contact Notification No. 1023

This document incorporates by reference the notifier's environmental assessment (EA), dated October 22, 2010.

The purpose of this supplement is to ensure the accuracy and completeness of the environmental record and to assist the public in understanding the agency’s basis for preparing a finding of no significant impact (FONSI).

The EA, incorporated by reference in this FONSI, discusses a use of the food-contact substance (FCS) in the tempering of wheat; however, the notifier subsequently rescinded that use on November 10, 2010. Therefore, such requested use is not considered part of the environmental considerations to support this FONSI.

 

Prepared by __________________________________________Date: January 5, 2011
Leah D. Proffitt
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration