Environmental Decision Memo for Food Contact Notification No. 1783
Recently Published Environmental Assessments and FONSIs
See also Environmental Decisions.
Date: July 14, 2017
To: Marla Swain, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Mariellen Pfeil, Acting Environmental Team Lead, Office of Food Additive Safety, HFS-255
From: Biologist, Environmental Team, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject: Finding of No Significant Impact for food-contact notification (FCN) 1783 for an aqueous mixture of peroxyacetic acid, (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), glycerol (CAS Reg. No. 56-81-5), and optionally acetic acid (CAS Reg. No. 64-19-7) or sulfuric acid (CAS Reg. No. 7664-93-9).
Notifier: Eltron Research & Development
Attached is the Finding of No Significant Impact (FONSI) for FCN 1783, request for use of an aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (PA), glycerol, and, optionally, acetic acid or sulfuric acid, as an antimicrobial to control microorganisms in process water used during the commercial preparation of processed meat and poultry, fish and seafood, and fruits and vegetables that are not raw agricultural commodities.
After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment (EA), dated May 30, 2017, may be made available to the public. We will post digital transcriptions of the FONSI and the EA 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. 1783), submitted by Eltron Research & Development, to provide for safe use of use of an aqueous mixture of peroxyacetic acid, hydrogen peroxide, glycerol, and, optionally, acetic acid or sulfuric acid, as an antimicrobial to control microorganisms in process water used during the commercial preparation of processed meat and poultry, fish and seafood, and fruits and vegetables that are not raw agricultural commodities.
The Office of Food Additive Safety has determined that allowing this FCN to become effective will not significantly affect the quality of the human environment and, therefore, an environmental impact statement will not be prepared. This finding is based on information submitted by the submitter in an environmental assessment, dated May 30, 2017. The EA is incorporated by reference in this Finding of No Significant Impact, and is briefly summarized below. The EA was prepared in accordance with 21 CFR 25.40.
The food-contact substance (FCS) is intended to inhibit the growth of undesirable or pathogenic microorganisms, and will be used in food processing facilities throughout the United States, as well as in open water, on-board fish processing. Waste water from the above-described use will be either discharged ultimately to a publicly-owned treatment works (POTW), or, if in possession of a National Pollutant Discharge Elimination System (NPDES) permit, directly to surface waters after onsite pre-treatment. In the case of on-board fish processing, effluent will be released directly to the open ocean.
The peroxygen components of the FCS (PAA, HP) are expected to degrade rapidly in the presence of organic material. Acetic acid readily biodegrades and sulfuric acid dissociates in the presence of water. Sodium acetate, which is a reaction by-product, is not highly toxic to aquatic organisms, dissociates into hydrogen proton and acetate anion, which readily biodegrades in activated treatment sludge. Glycerol partitions 100% to the aquatic compartment of the environment, and biodegrades under aerobic and anaerobic conditions.
No significant environmental impacts are expected from use and disposal of the FCS; therefore, no mitigation measures are needed. The alternative of not allowing the exemption request would be use of other antimicrobials already on the market; such action would have no new significant environmental impact.
Consequently, we find that use of the FCS as described in FCN 1783 will not cause significant adverse impacts on the human environment. Therefore, an environmental impact statement will not be prepared.
Prepared by __________________________________________Date: digitally signed 07-14-2017
Leah D. Proffitt
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by __________________________________________Date: digitally signed 07-14-2017
Mariellen Pfeil
Acting Environmental Team Lead
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration