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Date: January 10, 2017

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

Subject: Finding of No Significant Impact for FCN 1726 – 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-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally, sulfuric acid (CAS Reg. No. 7664-93-9).

Notifier: PeroxyChem, LLC

To: Anita Chang Ph.D., 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 Food Contact Notification (FCN) 1726.

After this FCN becomes effective, copies of this FONSI, the notifier's environmental assessment (EA), dated November 16, 2016, and an EA revision sheet, dated January 10, 2017 may be made available to the public. We will post digital transcriptions of the FONSI, the EA, and the revision sheet 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

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN 1726), submitted by PeroxyChem, LLC to provide for the safe use of 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-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and, optionally sulfuric acid (CAS Reg. No. 7664-93-9). The food contact substance (FCS) will be used as an antimicrobial agent in: (1) brines, sauces, and marinades applied either on the surface or injected into processed or unprocessed, cooked or uncooked, whole or cut, poultry or parts and pieces, and (2) surface sauces and marinades applied on processed and preformed meat and poultry products as described in 21 CFR 170.3(n)(29) and (34).

The Office of Food Additive Safety has determined that allowing food contact notification (FCN) 1726 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 November 16, 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 food contact substance (FCS) will be used as an antimicrobial agent in: (1) brines, sauces, and marinades applied either on the surface or injected into processed or unprocessed, cooked or uncooked, whole or cut, poultry or parts and pieces, and (2) surface sauces and marinades applied on processed and preformed meat and poultry products as described in 21 CFR 170.3(n)(29) and (34).

The antimicrobial agent is intended for use in brines, sauces and marinades at levels not exceeding 50 ppm peroxyacetic acid, 33 ppm hydrogen peroxide, and 3.3 ppm HEDP.

The antimicrobial agent is needed to inhibit the growth of undesirable or pathogenic microorganisms in the brines, sauces and marinades used in the production and preparation of poultry and processed and pre-formed meat and poultry products.

Introduction of Substances into the Environment as a Result of Use and Disposal
The waste process water containing the FCS is expected to be disposed of through the processing plant’s onsite wastewater treatment facility before discharge either to surface waters under National Pollution Discharge Elimination System (NPDES) permitting or to a publicly owned treatment works (POTW).

Treatment of the process water at an on-site wastewater treatment plant or POTW is expected to result in the complete degradation of PAA, hydrogen peroxide, and acetic acid. Specifically, the PAA will breakdown into oxygen, and acetic acid, while hydrogen peroxide will break down into oxygen and water. Acetic acid is rapidly metabolized by ambient aerobic microorganisms to carbon dioxide and water. Sulfuric acid is a strong, diprotic, mineral acid that dissociates readily in water to sulfate ions and hydrated protons; and is totally miscible in water. Sodium sulfate/sulfuric acid are substances with favorable ecological profiles. Due to the low aquatic toxicity and the natural recycling that occurs in the sulfur cycle, wide dispersive use of sodium sulfate does not present a major hazard to the environment. Therefore, the EA focuses on the environmental impacts of HEDP.

The use level of 3.3 ppm for HEDP was determined to be the worst-case environmental introduction concentration (EIC)total for all processing facilities using the FCS in the intended applications. HEDP is a chelating agent and exhibits unique partitioning behavior such that 80% adsorbs to wastewater treatment sludge, while the remaining 20% stays in the water. Applying the 80:20 partitioning factors yields an environmental introduction concentration (EIC) in sludge of 3.3 ppm x 0.8 = 2.6 ppm and an EIC of 0.7 ppm in water. In order to arrive at the effective environmental concentration (EEC) in water, a 10-fold dilution factor is applied to the HEDP that remains in water to account for dilution upon release to surface water: EIC ÷ 10 = 0.07 ppm.

Terrestrial Ecotoxicity
HEDP shows no toxicity to terrestrial organisms at levels up to 1,000 mg/kg (ppm) soil dry weight (No Observed Effect Concentration; NOEC]). The maximum EEC in sludge is 2.6 ppm, therefore the FCS is not expected to have any terrestrial environmental toxicity concerns at levels at which it is expected to be present in sludge or soil. Moreover, the much smaller amount of HEDP present in surface water is not expected to have any adverse environmental impact with sedimentation based on the terrestrial toxicity endpoints available for plants, earthworms, and birds.

Aquatic Ecotoxicity
The lowest relevant HEDP endpoint for aquatic toxicity was determined to be the chronic NOEC of 10 ppm for Daphnia magna. The conservatively estimated EEC of 0.07 ppm is greater than 140-fold lower than the 10 ppm chronic NOEC for Daphnia magna; therefore, use of the FCS is not expected to have an adverse effect on aquatic organisms.

Use of Resources and Energy
Use of the FCS will not require additional energy resources for treatment and disposal of waste solution, as the components readily degrade. The raw materials that are used in the manufacture of the FCS are commercially manufactured chemicals that are produced for the use in various chemical reactions and used for production purposes. Thus the energy used for the production of the FCS is not significant.

Mitigation Measures
No significant adverse environmental impacts are expected to result from the use and disposal of the FCS. Therefore, mitigation measures are not identified in the EA.

Alternatives to the Proposed Action
No potential adverse environmental effects were identified in the EA that would necessitate alternative actions for the proposed use in this Food Contact Notification. If the proposed action is not approved, the result would be the continued use of the currently marketed antimicrobial agents that the subject FCS would replace. Such action would have no environmental impact. The addition of the antimicrobial agent to the options available to food processers is not expected to increase the use of peroxyacetic acid antimicrobial products.

As evaluated in the EA, the proposed use of the FCS as an antimicrobial agent as described in FCN 1726 is not expected to significantly affect the human environment; therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 01-10-2017
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 01-10-2017
Suzanne Hill
Environmental Team 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 November, 2016 EA for FCN 1726

Dated: January 10, 2017

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of November 16, 2016 for food contact notification (FCN) 1726 concluded that the action will not constitute a significant impact. These revisions are issued to make a minor change and clarification that should be acknowledged, while not making any substantive changes to the EA. These revisions do not impact our Finding of No Significant Impact and are as follows:

• Page 2, paragraph 1 of the EA, we note the meaning of the following acronyms: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), United States Department of Agriculture / Food Safety and Inspection Service (USDA/FSIS), and Generally Recognized as Safe (GRAS).
• Footnote 5 of the EA references, “Human and Environmental Risk Assessment (HERA) on ingredients of European Household Cleaning Products: Phosphonates (2004).” The correct reference is found in footnote 4 and is “The Organisation for Economic Co-operation and Development (OECD) SIDS Voluntary Testing Program for International High Production Volume Chemicals (OECD SIDS), Sulfuric Acid, 2001.”