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Environmental Decision Memo for Food Contact Notification No. 1664

Environmental Decision Memo for Food Contact Notification No. 1664

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: July 15, 2016

From: Physical Scientist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: Finding of No Significant Impact for FCN No. 1664 – An aqueous mixture of peroxyacetic acid (CAS Reg. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).

Notifier: CraftChem, Inc.

To: Elizabeth J. Petro, PhD., Division of Food Contact Notifications (HFS-275)
Through: Suzanne Hill, Environmental Team Supervisor, Office of Food Additive Safety, HFS 255

Attached is the Finding of No Significant Impact (FONSI) for FCN 1664. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated May 20, 2016, 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.

Antonetta Thompson-Wood

Attachment: Finding of No Significant Impact


FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1664), submitted by CraftChem, Inc.to provide for the safe use of an aqueous mixture of peroxyacetic acid (CAS Reg. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9) as an antimicrobial agent for use in process water and ice used in the production and preparation of whole or cut meat and processed and pre-formed meat.

The Office of Food Additive Safety has determined that allowing food contact notification (FCN) 1664 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 submitted by the notifier in an environmental assessment, dated May 20, 2016, as summarized below. 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 on meat portions and products, ultimately providing safer meat products for human consumption throughout the United States. Use concentrations are as follows:

(1) 1800 ppm peroxyacetic acid (PAA), 600 ppm hydrogen peroxide (HP), and 22.5 ppm 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) in process water or ice used for washing, rinsing, or cooling whole or cut meat including carcasses, parts, trim and organs; and

(2) 495 ppm PAA, 165 ppm HP, and 14 ppm HEDP in process water, brine, or ice used for washing, rinsing, or cooling processed and pre-formed meat.

The in-use concentrations of the diluted FCS solution (up to 1800 ppm PAA) is intended for use at meat processing plants in times of increased microbial stress to control undesirable microbial contamination of meat. This product also inhibits and/or reduces meat surface microbial contamination.

For meat processing plants that hold a National Pollutant Discharge Elimination System (NPDES) permit (i.e., direct dischargers), the FCS-containing wastewater will be treated on-site before being directly discharged to surface waters. For meat processing plants without a NPDES permits (i.e., indirect dischargers), the FCS-containing wastewater will undergo pretreatment on-site, prior to discharge to Publicly Owned Treatment Works (POTWs) for standard wastewater treatment. As discussed in the EA, process water at an on-site wastewater treatment plant or POTW is expected to result in the complete degradation of PAA, HP, and acetic acid. Specifically, PAA will breakdown into oxygen, water and acetic acid, while hydrogen peroxide will break down into oxygen and water. Acetic acid is not expected to concentrate in the wastewater discharged to the treatment facility/POTW. As such, the environmental impacts of these FCS components are not considered in further detail in the EA. The EA focuses on the environmental fate and effects of HEDP. Additionally, the EA used as a conservative assumption, the higher in-use concentration for the proposed use on whole or cut meat, carcasses, parts, trim, or organs to estimate the environmental exposure to HEDP.

As no release to the air are expected from the use of the FCS, the EA focuses on impacts to aquatic and terrestrial environment.

Effects to Terrestrial Environment

HEDP shows no toxicity to terrestrial organisms at levels up to 1,000 ppm (No Observed Effect Concentration [NOEC]). As shown in the EA, the conservative expected environmental concentration (EEC)of HEDP in sludge is 18.0 ppm, which is roughly one order of magnitude lower than the most sensitive terrestrial endpoint; therefore, there is no toxicity expected from land application of sludge that contains HEDP as a result of the use of the FCS.

Effects to Aquatic Environment

In evaluation of the aquatic toxicity of the FCS, the lowest relevant endpoint for aquatic toxicity was determined to be the chronic NOEC of 10 ppm for Daphnia magna. As shown in the EA, the conservative EEC of HEDP is 0.45 ppm, when compared to aquatic toxicity endpoints is more than one order of magnitude lower than the chronic NOEC for Daphnia magna; the most sensitive aquatic toxicity endpoint. Therefore, we find that the use of the FCS is not expected to have an adverse effect on aquatic organisms.

Use of Resources and Energy

The FCS will be competing with and/or replacing other currently marketed products used as antimicrobial agents at meat plants nationwide. Use of the FCS is therefore anticipated to have no net effect on resources or energy associated with typical use of such antimicrobial agents in solution.

Alternatives to the Proposed Action

The addition of this product to the options available to meat processors is not expected to increase the use of PAA antimicrobial agent products; rather, it will serve as a replacement product, competing with those already in use in the market place. No potential adverse environmental effects were identified in the EA that would require evaluation of reasonable alternatives actions for the proposed use in this FCN. The alternative of not approving the proposed action would be the continued use of the materials that the FCS would replace. Such action would have no environmental impact.

As evaluated in the EA, the proposed use of the FCS as described in FCN 1664, which is as an antimicrobial agent for use in process water and ice used in the production and preparation of whole or cut meat and processed and pre-formed meat, is not expected to have a significant environmental impact, and an environmental impact statement will not be prepared.

Prepared by ____________________________________________Date: digitally signed on 07-19-2016
Antonetta Thompson-Wood
Physical Scientist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by ____________________________________________Date: digitally signed on 07-19-2016
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration