Environmental Decision Memo for Food Contact Notification No. 1639

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1639), submitted by Lewis & Harrison LLC on behalf of Biosan LLC to provide for the safe use of an aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (HP), acetic acid (AA), 1-hydroxyethylidine-1, 1-diphosphonic acid (HEDP), dipicolinic acid (DPA), and optionally, sulfuric acid as an antimicrobial agent in process water, brine, and ice used in the production and preparation poultry, meat, processed and pre-formed meat and poultry, and fruits and vegetables.

The Office of Food Additive Safety has determined that allowing this food contact notification (FCN) 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 EA dated February 12, 2016, as summarized below.

The FCS will be used as an antimicrobial agent in the production and preparation poultry, meat, processed and pre-formed meat and poultry, and fruits and vegetables at levels not to exceed:

Use	PAA	HP	HEDP	DPA
Whole or cut poultry carcasses parts, trim, and organs: In spray, wash, rinse, dip, chiller water, low-temperature (e.g., less than 40°F) immersion baths, or scald water	2000 ppm	933 ppm	120 ppm	0.5 ppm
Whole or cut meat, including carcasses, parts, trim, and organs: In process water, ice, or brine used for washing, rinsing, or cooling	400 ppm	187 ppm	24 ppm	0.5 ppm
Processed and pre-formed meat as defined in 21 CFR § 170.3(n)(29) and poultry as defined in 21 CFR § 170.3(n)(34): In process water, ice, or brine used for washing, rinsing, or cooling	230 ppm	107 ppm	14 ppm	0.1 ppm
Fruits and vegetables: In process water for washing or chilling in food processing facilities	80 ppm	37 ppm	5 ppm	0.25 ppm

The FCS is intended for use in meat, poultry, and fruit and vegetable processing plants throughout the United States.

The antimicrobial agent reduces or eliminates pathogenic and non-pathogenic microorganisms that may be present on the food. Use of the FCS helps to increase the safety and shelf-life of the treated food.

Introduction of Substances into the Environment as a Result of Use

It is expected that on-site wastewater treatment facilities will discharge to publically-owned treatment works (POTWs) or, if in possession of a National Pollutant Discharge Elimination System (NPDES) permit, directly to surface waters. Introduction of dilute solutions of the product into the environment will take place primarily via release from wastewater treatment systems or on-site treatment. Introduction of the components of the FCS into the environment will result from use of the product as an antimicrobial agent in processing water and the subsequent disposal of such water drainage into on-site treatment plants and/or POTWs.

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, AA and sulfuric 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. Sulfuric acid will completely dissociate into sulfate ions and hydrated protons, neither of which are a toxicological or environmental concern at the proposed use levels. 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 and DPA.

As the use level concentrations for HEDP (120 ppm) and DPA (0.5 ppm) in processing of whole or cut poultry were higher than in the other uses of the FCS, and as large-scale facilities do not typically process more than one type of food, the EECs from this use profile were used to determine the significance of impacts to the terrestrial and aquatic environment.

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]). As shown in the EA, the maximum expected environmental concentration (EEC) in sludge is 96 ppm, therefore there is no toxicity expected from land application of sludge that contains HEDP as a result of the use of the FCS.

Due to its water solubility, partitioning of DPA into sludge is not likely. Accordingly, terrestrial releases of DPA from the intended uses of the FCS are anticipated to be negligible and no toxicity concerns are expected.

Aquatic Ecotoxicity

In evaluation of the aquatic toxicity of the FCS, the lowest relevant HEDP endpoint for aquatic toxicity was determined to be the chronic NOEC of 10 ppm for Daphnia magna. The calculated HEDP EEC resulting from processed poultry use is 2.4 ppm and is approximately 5-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.

The highest calculated EEC for DPA is 0.05 ppm. This value is more than 2000-fold lower than the predicted DPA toxicity values (322, and 89 mg/L LC50s for fish and Daphnids, respectively) determined using the USEPA ECOSAR (Ecological Structure Activity Relationship) model. Therefore, the aquatic risks for the intended uses of DPA are expected to be negligible.

Use of Resources and Energy

The 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 production of the mixture are commercially-manufactured materials that are produced for use in a variety of chemical reactions and production processes. Energy used specifically for the production of the mixture components is not significant.

Alternatives to the Proposed Action

No potential adverse environmental effects were identified in the EA that would require evaluation of reasonable alternatives for the proposed use in this FCN. 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 not have a significant environmental impact.

As evaluated in the EA, the proposed use of the FCS as an antimicrobial agent for use in the production and preparation poultry, meat, processed and pre-formed meat and poultry, and fruits and vegetables is not expected to have a significant environmental impact; therefore, an environmental impact statement will not be prepared for FCN 1639.

Prepared by ____________________________________________Date: Digitally signed 03-14-2016
Mariellen Pfeil
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by ____________________________________________Date: Digitally signed 03-14-2016
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied