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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. 000951

 

Date:December 28, 2009
From:Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 951 - Peroxyacetic acid solution as an antimicrobial agent added to process water used for washing meat carcasses, parts, trim, and organs.
Notifier:Evonik Degussa Corporation
379 Interpace Parkway
Parsippany, NJ 07054
 
To:Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams
Through: William H Lamont, Acting Supervisor, ERT
 

The food contact substance is an aqueous mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidine-1,1-diphosphonic acid, and sulfuric acid.

Attached is the Finding of No Significant Impact (FONSI) for FCN 951. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated November 10, 2009, 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.

 

Attachment:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 951


Finding of No Significant Impact

A food contact notification (FCN No. 951), submitted by Evonik Degussa Corporation, to provide for the safe use of an aqueous mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidine-1,1-diphosphonic acid, and sulfuric acid as an antimicrobial agent added to process water used for washing meat carcasses, parts, trim, and organs.

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 November 10, 2009, in the notification submitted by the notifier, our supplement to the environmental record, and other information known to the agency.

 

Prepared by __________________________________________Date: December 28, 2009
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, 2009
William H Lamont, 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. 951

This document incorporates by reference the notifier's environmental assessment (EA), dated November 10, 2009.

The composition described in the EA for the notified use of the food-contact substance (FCS) was slightly different from that made effective in the food contact notification (FCN). In the EA, the maximum concentration of hydrogen peroxide (HP) is 50 ppm; the maximum concentration of 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) is 1 ppm. In the effective FCN, HP is 75 ppm; HEDP is 13 ppm.

The concentrations of HP (75 ppm) and HEDP (13 ppm) reflect limits for those two components regulated for the intended uses under 21 CFR 173.370. The agency has already previously examined those higher concentrations and has found no significant environmental impacts exist that pertain to the higher maximum concentrations. The agency is not aware of any new information regarding environmental risks specific to HP at 75 ppm and HEDP at 13 ppm that would lead to a conclusion contrary to the previous environmental decisions. Based upon essentially the same considerations found in those environmental decisions involving related uses and subsequent disposal from uses for the formulation, the agency does not reasonably expect a significant effect on the environment from an action to make effective this notification.

 

Prepared by __________________________________________Date: December 28, 2009
Hoshing W Chang, Ph.D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration