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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. 001118

Date:September 1, 2011
From:Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Office of Food Additive Safety (HFS-255)
Subject:FCN No. 1118 – 1,3-dibromo-5,5-dimethylhydantoin (DBDMH) as an antimicrobial additive in process water for fruits and vegetables, and as an antimicrobial component of shell egg wash solutions.
Notifier:Albemarle Corporation
451 Florida Street
Baton Rouge, LA 70801
To:Division of Food Contact Notifications (HFS-275)
Attention: Mark A. Hepp, Ph.D.
Through: Annette M McCarthy, PhD, Senior Science and Policy Staff

Attached is the Finding of No Significant Impact (FONSI) for FCN 1118. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated August 1, 2011, 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.

 

Leah D. Proffitt

 

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food-contact notification (FCN No. 1118), submitted by Albemarle Corporation, to provide for the safe use of 1,3-dibromo-5,5-dimethylhydantoin (DBDMH) as an antimicrobial in water used in fruit and vegetable processing and in sanitizing shell eggs.

The Office of Food Additive Safety 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 August 1, 2011, in the notification submitted by the notifier, and other information known to the agency.

 

Prepared by __________________________________________Date: September 1, 2011
Leah D. Proffitt
Environmental Reviewer
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: September 1, 2011
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration