Environmental Decision Memo for Food Contact Notification No. 001394

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Date: January 15, 2014

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

Subject: FCN No. 1394 – An aqueous mixture containing peroxyacetic acid (PAA), hydrogen peroxide (H2O2), sodium hydroxide, acetic acid, 1-hydroxyethylidene-1, 1-diphosphonic acid (HEDP), and optionally sulfuric acid as an antimicrobial in process water or ice for washing, rinsing, cooling, or storing of whole or cut meat including carcasses, parts, trim, and organs

Notifier: FMC Corporation

To: Marla Swain Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____

Attached is the Finding of No Significant Impact (FONSI) for FCN 1394. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated November 19, 2013, 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.

Leah D. Proffitt

Attachment: Finding of No Significant Impact

File: FCN No. 1394


A food-contact notification (FCN No. 1394), submitted by FMC Corporation, to provide for the safe use of an aqueous mixture containing peroxyacetic acid (PAA), hydrogen peroxide (H2O2), sodium hydroxide, acetic acid, 1-hydroxyethylidene-1, 1-diphosphonic acid (HEDP), and optionally sulfuric acid as an antimicrobial in process water or ice used in processing of whole or cut meat, carcasses, parts, trim, and organs.

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, 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 19, 2013, as summarized below.

The FCS is intended to inhibit the growth of undesirable or pathogenic microorganisms in process water and ice used to prepare whole or cut meat including carcasses, parts, trim, and organs, and will be used at the following concentrations:               

PAA:      400 ppm

H2O2:     267 ppm

HEDP:    27 ppm

Statements in the EA indicate that the proposed use requested in this FCN is intended to be substitutional for FCNs 1247 or 1132. The proposed use concentrations and applications for the current FCN differ in significant ways from those in FCNs 1132 and 1247, such that the levels cannot be considered to be “the same as those” in the FCNs 1132 and 1247.  While the PAA and are H2O2 are lower than the authorized uses for both FCNs, the use level of HEDP, the primary chemical of concerns is higher than the authorized use level in FCN 1132 such that it cannot be considered substitutional. Further while the use level of HEDP is for FCN 1247 was more than 5 times the current concentration, that use level was approved for use with fish, seafood, meat and poultry. Agency experience is that the use level in poultry is greater than that needed to treat meat. Therefore, while the apparent maximum use levels are significantly different, we do not believe that the actual levels used on meat are as high as authorized. We cannot determine if the use is substitutional with the information provided. 

The sulfuric acid component of the FCS has been affirmed as “generally recognized as safe” (GRAS) under 21 CFR 184.1095 at levels not to exceed good manufacturing practices, thus the compound is already regulated for the requested use and FDA’s decision in regard to it in this FCN does not constitute a “major federal action” requiring NEPA review. Therefore, the environmental impacts were not considered.

The FCS concentrate will be diluted on site to the proposed use concentrations noted above. Since PAA and H2O2 are expected to degrade rapidly in the presence of organic material such as that in wastewater treatment plants, and therefore are not expected to enter the environment, the EA focuses on the environmental introduction and fate of HEDP.

As noted above, the peroxygen compounds of the FCS are expected to degrade rapidly in the presence of organic material. For acetic acid, a study by the U.S. High Production Volume (HPV) Chemical Challenge Program, has determined that 99% of acetic acid degraded in 7 days under anaerobic conditions, and therefore is not expected to concentrate in the waste water that is discharged to municipal treatment plants.

According to the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), the half-life for PAA in buffered solutions was 64 hours (pH = 7) for a 748 ppm solution and 48 hours (pH = 7) for a 95 ppm solution while the half-life for hydrogen peroxide varies based on the surface water.

Water is used at meat processing plants for purposes other than the processing or washing of meat, such as sanitizing of the facility or equipment. Therefore, it is assumed the environmental introduction concentration (EIC) will be diluted below the intended use level of 27 ppm. To estimate this value, average industry values were used. A large plant processes 5000 head cattle/day in two 8-hour shifts (960 min.), and discharges an average of 300 gal/head waste water. The waste water includes all water used at the plant, including that which does not contact the food. Thus, the HEDP environmental introduction concentration (EIC) is calculated as follows:

(27 μg HEDP/g wash water)(454 g wash water/lb)(8.3 lb/gal wash water)(660 gal wash water/min) ÷ (5000 head/960 min)(300 gal total water/head)(8.3 lb/gal)(454 g total water/lb) = 11.4 μg HEDP/g total waste water = 11.4 ppm.

Waste water from the food processing operations described above is expected to be released to a publicly-owned treatment works (POTW) where the concentration of the HEDP will be further diluted by the additional waters processed by the POTW.  Assuming no HEDP degradation in the POTW, and applying a 10-fold dilution factor to the EIC calculated above results in an effective environmental concentration (EEC) of approximately 1.14 ppm for HEDP.

According to a Jaworska et. al. study referenced in the EA, that reflects the agency’s current understanding of HEDP, the primary adverse effects of HEDP result from chelation of nutrients rather than direct toxicity of HEDP. Chelation is not toxicologically relevant in the current evaluation because eutrophication, not nutrient depletion, has been demonstrated to be the controlling toxicological mode when evaluating wastewater discharges from food processing facilities. The lowest short-term LC50 values published for Selenastrum capricornutm (3 ppm), Daphnia magna (165 ppm), and Crassostrea virginica (89 ppm) are acute toxicity endpoints considered to result from this chelation effect. These values are not relevant when excess nutrients are present as expected in food processing wastewaters. The lowest relevant endpoint for food processing uses was determined by Jaworska et al. in the HERA study to be the chronic NOEC of 10 ppm for Daphnia magna. Although the uncertainties intrinsic to its derivation make the usefulness of the NOEC/NOEL debatable, even to the point that it has been recommended that they be abandoned and replaced by other statistics such as EC50/LC50 [1], in this case, the acute EC50/LC50 values reflect effects from chelation, which is not representative of the current high-nutrient situation where eutrophication and not nutrient depletion is the primary concern. Therefore, while NOEC values are not ideal, they were used to evaluate the environmental impact as they are the only relevant toxicity values currently available. The EEC of 1.14 ppm is approximately 1 order of magnitude lower than the 10 ppm chronic NOEC for Daphnia magna. Thus no significant environmental impacts are anticipated from the proposed use and disposal of the FCS.

Prepared by; __________________________________________Date: January 15, 2014
Leah D. Proffitt
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: January 15, 2014
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

[1] Blok, J. and F. Balk, 1995. "Environmental Regulation in the European Community," in Fundamentals of Aquatic Toxicology: Effects, Environmental Fate, and Risk Assessment, (GM Rand, Ed.), Taylor & Francis, New York, 1995, chapter 27. NOEC determinations are likely more statistically variant (uncertain) than EC50 determinations.

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