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Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1638

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.


Date: April 19, 2016

From: Talia A. Lindheimer, Biologist, Environmental Review Team, Division of Biotechnology and GRAS Notice Review, HFS-255

Subject: Finding of No Significant Impact for Food Contact Notification 1638

Notifier: Xgenex, LLC

To: Vivian Gilliam, Consumer Safety Officer, Division of Food Contact Notifications, HFS-275

Through: Suzanne Hill, Environmental Supervisor, Office of Food Additive Safety, HFS-255

Attached is the Finding of No Significant Impact (FONSI) for Food Contact Notification 1638, which is for an antimicrobial agent that is an aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethane 1,1-diphosphonic acid (CAS Reg. No. 2809-21-4), and optionally, sulfuric acid (CAS Reg. No. 7664-93-9).

After this notification becomes effective, copies of this FONSI, revision sheet, and the notifier's environmental assessment, dated February 22, 2016, may be made available to the public. We will post digital transcriptions of the FONSI, revision sheet, 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.

Talia A. Lindheimer

Attachments: Finding of No Significant Impact
EA Revision Sheet


FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN) No. 1638, submitted by Xgenex, LLC, to provide for the safe use of the food contact substance (FCS) which is an aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), 1-hydroxyethane 1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally, sulfuric acid (CAS Reg. No. 7664-93-9). The intended use of the FCS is as an antimicrobial agent for use in:

1) process water or ice used for washing, rinsing, or cooling whole or cut meat, including carcasses, hides, parts, trim, and organs as defined in 21CFR170.3 (n)(17)(29). The components of the FCS mixture will not exceed: 460 parts per million (ppm) peroxyacetic acid, 220 ppm hydrogen peroxide, and 30 ppm HEDP;

2) process water applied as a spray, wash, rinse, dip, chiller water, post-main chiller, secondary processing, pre-air chiller dip tanks and post-main water chiller systems as finishing chillers, low-temperature (e.g., less than 40°F) immersion baths, or scald water for poultry carcasses, parts and pieces, and skin on or off and organs. The components of the FCS mixture will not exceed: 2000 ppm peroxyacetic acid, 950 ppm hydrogen peroxide, and 113 ppm HEDP;

3) process water, ice, or brine used for washing, rinsing, or cooling of processed and pre-formed meat and poultry products as defined in 21CFR170.3(n)(17)(18)(29)(34). The components of the FCS mixture will not exceed: 230 ppm peroxyacetic acid, 110 ppm hydrogen peroxide, and 15 ppm HEDP;

4) process water or ice used to commercially prepare fish and seafood. The components of the FCS mixture will not exceed: 230 ppm peroxyacetic acid, 110 ppm hydrogen peroxide, and 15 ppm HEDP;

5) process water that contacts fruits and vegetables in a food processing facility. The components of the FCS mixture will not exceed: 350 ppm peroxyacetic acid, 165 ppm hydrogen peroxide, and 23 ppm HEDP.

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, an environmental impact statement will not be prepared. This finding is based on information submitted by the notifier in an environmental assessment, dated February 22, 2016. 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 FCS is intended to inhibit the growth of undesirable or pathogenic microorganisms in process water used for food processing throughout the United States.

When the FCS is used aboard fishing vessels, the water containing the FCS is expected to be disposed back into the open waters, as this is a common practice within the fishing industry. As the dilution resulting from discharge into the ocean will result in a negligible concentration, it has been determined that there will be no significant impacts from this use.

When the FCS is used at land-based processing plants, disposal of process water will be via onsite wastewater treatment ultimately to a publicly-owned treatment works (POTW), or, if in possession of a National Pollutant Discharge Eliminations System (NPDES) permit, directly to surface waters. As PAA, HP, and AA will degrade rapidly in the presence of organic matter, and sulfuric acid will readily dissociate in the presence of water, the component of environmental concern when the FCS is used at these land-based processing facilities is the phosphonate, HEDP. Analysis of impacts from HEDP is based on the worst case/highest use level, i.e. poultry at 113 ppm HEDP.

Conservatively, we evaluated a HEDP adsorption to wastewater treatment sludge at 80%, and with 20% of HEDP remaining in the aquatic environment. Therefore, the expected environmental concentration (EEC) for HEDP in sludge is estimated at 90.4ppm. As we estimate that HEDP will be diluted upon discharge into surface water, the aquatic EEC is estimated at2.3ppm. HEDP shows no toxicity to terrestrial organisms at levels up to 1000 mg/kg soil dry weight (No Observed Effect Concentration; NOEC), and the lowest relevant endpoint for aquatic toxicity has been determined to be the chronic NOEC of 10 ppm for Daphnia magna. Therefore, we do not expect adverse effects to terrestrial or aquatic organisms from the proposed use of the FCS.

As indicated in the EA, we do not expect a net increase in the use of energy and resources from the use of the FCS. As, the use and disposal of the antimicrobial agent is not expected to result in significant adverse environmental impacts; mitigation measures are not identified.

No potential adverse environmental effects are identified in the EA, which would necessitate alternative actions to that proposed in this FCN. The alternative of not approving the action proposed herein would result in the continued use of the materials which the FCS would otherwise replace; such action would have no environmental impact.

As FDA has determined that the intended use of the FCS, as described in FCN 1638, will not significantly affect the human environment; an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: Digitally signed 04-19-2016
Talia A. Lindheimer
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: Digitally signed 04-25-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


U.S. Food and Drug Administration
Revision Sheet for the February 22, 2016 EA for Food Contact Notification 1638
Dated: April 19, 2016

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of February 22, 2016, concluded that the action will not constitute a significant impact. The revision is issued to make a minor change and update of an editorial nature that should be acknowledged, while not making any substantive changes to the EA. This revision does not impact our Finding of No Significant Impact (FONSI).

The revision is necessary to be consistent with the description of the intended use of the food contact substance (FCS) as described in the final acknowledgement letter. The following revision is for Item 4. Requested Action, located on page 1 of the EA.

The EA states the FCS will be used, “in process water or ice for washing, rinsing, storing or cooling of processed and pre-formed meat and poultry products.” The FCS is not authorized for use in process water used to store processed and pre-formed meat and poultry products. The quoted text should read, “in process water or ice for washing, rinsing or cooling of processed and pre-formed meat and poultry products.”