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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. 001018

Date:December 28, 2010
From:Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 1018 – Bacterial phages as an antimicrobial agent applied to red meat parts and trim prior to grinding.
Notifier:Intralytix, Inc.
701 East Pratt Street
Baltimore, MD 21202
To:Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams
Through: William H. Lamont, Acting Supervisor, ERT

The food-contact substance is a mixture of equal proportions of lytic-type phages, ECML-4 (157,308 bp), ECML-117 (66,854 bp), and ECML-134 (166,783 bp), isolated from fresh and salt water environments in phosphate-buffered saline.

Attached is the Finding of No Significant Impact (FONSI) for FCN 1018. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated October 27, 2010, may be made available to the public. We will 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.

 

Hoshing W Chang, Ph.D.

 

1 Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 1018), submitted Intralytix, Inc., to provide for the safe use of a mixture of equal proportions of lytic-type phages, ECML-4 (157,308 bp), ECML-117 (66,854 bp), and ECML-134 (166,783 bp), isolated from fresh and salt water environments in phosphate-buffered saline as an antimicrobial agent applied to red meat parts and trim prior to grinding.

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, including an environmental assessment, dated October 27, 2010, in the notification submitted by the notifier, and other information known to the agency.

 

Prepared by __________________________________________Date: December 28, 2010
Hoshing W Chang, Ph.D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: December 28, 2010
William H. Lamont, Acting Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration