Environmental Decision Memo for Food Contact Notification No. 1815

Recently Published Environmental Assessments and FONSIs

FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1815), submitted by PeroxyChem, LLC., to provide for safe use of use of an aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (HP), acetic acid (AA), with oxalic and/or maleic acid, as an antimicrobial agent for the commercial sterilization of aseptic filling equipment and polymeric food packaging prior to filling, except for use on food packaging used in contact with infant formula or human milk or on aseptic filling equipment used to fill such packaging, as described below.

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 August 31, 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 for the commercial sterilization of aseptic filling equipment and polymeric food packaging prior to filling throughout the United States. 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. For each application, the concentration of PAA may not exceed 4000 parts per million (ppm) in the FCS. The proposed uses are as follows:

The FCS is applied as a fine mist or vapor on polymeric food packaging containers and closures without a rinse prior to filling with food. For this application of the FCS, the sum of the concentrations of oxalic and maleic acid may not exceed 267 ppm in the FCS. The maximum application rate in milliliters of FCS per packaging container is given by the formula: 70 x (container capacity in fluid ounces)/[PAA ppm] in the FCS.
Food packaging containers and closures are filled with the FCS, drained, and rinsed with sufficient sterile water to achieve a theoretical 60-fold dilution of the FCS residue assumed to be 1 mg/cm2 on the interior container surface following draining.
The FCS is applied as a spray to sterilize the non-food contact surfaces of aseptic filling equipment and subsequently rinsed with sterile water. FDA’s review of the use of the FCS to sterilize aseptic filling systems is limited to the extent that the FCS residues may transfer from the non-food contact surfaces of the aseptic filling system to food packaging materials

The peroxygen components of the FCS (PAA, HP), and the acetic acid are expected to degrade rapidly in the presence of organic material. Thus, the focus of the environmental analysis is on the stabilizers oxalic acid and maleic acid.

The aquatic environmental introduction concentration (EIC) from the proposed use is 8.2 mg stabilizer/L effluent. In order to arrive at the aquatic effective environmental concentration (EEC), a 10-fold dilution factor is applied to the EIC to account for dilution upon release to surface water (EIC ÷ 10 = EEC). Therefore, the aquatic EEC is 0.82 mg/L (ppm) receiving water. The terrestrial EIC is 3.5 mg stabilizer/kg treatment sludge. Accounting for 2.5% dilution upon commingling of sludge with soil yields a terrestrial EEC of 0.09 mg/kg soil (ppm). Atmospheric introductions are expected to be virtually nil.

Maleic acid is readily biodegradable in the terrestrial and aquatic compartments. Short-term EC50 was determined at 200 mg/L for Daphnia. A chronic NOEC (Alga; growth inhibition) was determined to be 130 mg/L. Oxalic acid is ubiquitous in the environment, occurring in many human diet food staples (e.g. spinach, broccoli, Brussels sprouts, etc.) at concentrations between 0.01% and 1.7% (equivalent to 100 and 17,000 ppm), i.e. much higher than the EECs from the proposed use.

Comparison of the above-cited EECs with short- and long-term toxicity endpoints shows that the proposed use of the FCS is not expected to cause significant adverse effects in the environment.

Use of the FCS is not expected to cause a significant impact on resources or energy. No mitigation measures are needed since no significant adverse impacts are expected from use of the FCS. The alternative to not allowing the FCN to become effective would be continued use of currently approved antimicrobial agents; such action would have no significant environmental impact.

As evaluated in the EA, the use of the FCS as described in FCN 1815 is not expected to significantly affect the human environment, and, therefore an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 11-15-2017
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 11-15-2017
Mariellen Pfeil
Acting Environmental Team Lead
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration