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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001036

Date:January 5, 2011
From:Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 1036 – Hypobromous acid, generated from aqueous hydrogen bromide and sodium, potassium, or calcium hypochlorite, as an antimicrobial in water or ice used for processing meat products.
Notifier:Enviro Tech Chemical Services
500 Winmoore Way
Modesto, CA 95358
To:Division of Food Contact Notifications (HFS-275)
Attention: Vanee Komolpraesert, Ph.D.
Through: William H Lamont, Acting Supervisor, ERT

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the environmental record for FCN 1036. After this notification becomes effective, copies of the FONSI, the notifier's environmental assessment, dated October 26, 2010, and the supplement to the environmental record may be made available to the public. We shall 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
Supplement to the Environmental Record for Food Contact Notification No. 1036


Finding of No Significant Impact

A food contact notification (FCN No. 1036), submitted by Enviro Tech Chemical Services, Inc., to provide for the safe use of hypobromous acid, generated on-site from an aqueous mixture of hydrogen bromide and sodium, potassium, or calcium hypochlorite, as an antimicrobial in water or ice used for processing meat products.

The Environmental Review Team 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 October 26, 2010, our supplement to the environmental record for FCN 1036, and other information known to the agency.

 

Prepared by __________________________________________Date: January 5, 2011
Leah D. Proffitt
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: January 5, 2011
William H. Lamont, Chemist
Acting Supervisor, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


Supplement to the Environmental Record for Food Contact Notification No. 1036

This document incorporates by reference the notifier's environmental assessment (EA), dated October 26, 2010.

The purpose of this supplement is to ensure the accuracy and completeness of the environmental record and to assist the public in understanding the agency’s basis for preparing a finding of no significant impact (FONSI).

On pages 67 and 70, the average water discharge of 981 gal/head for cattle slaughter, based on the mid-range of water use between 885 to 1077 gal/1000 lbs live weight, was slightly misstated. Given that the average weight of slaughtered cattle is 1275 lbs/head (reported in reference 5 of the EA), the mid-range water use, 981 gal/1000 lbs live weight, actually converts to 1250 gal/head cattle.

The gravimetric factors listed on page 69 should be 0.722 g NaCl/g HBr (instead of 0.772) and 0.921 g KCl/g HBr (instead of 0.992). The gravimetric factor for calcium chloride is based on two moles of HBr so that the factor is expressed properly as 111 g CaCl2/161.8 g HBr and not as 111 g CaCl2/80.9 g HBr.

On pages 69 and 71 of the EA, the concentration of bromide derivable from the spent food-contact substance (FCS) is 900 ppm and not 450 ppm. The FCS, hypobromous acid, is expressed as molecular bromine to represent the available reactive capacity. Bromide is the actual principal decomposition product of the FCS. Therefore, consonant with conservation of mass, the virtual concentration of the FCS, 900 ppm bromine, becomes the actual concentration of bromide when the reactive capacity is fully depleted.

On page 71, the computation in item "a" for meat processing should be based on a total water use of 1250 gal/head instead of 981 gal/head. The resulting dilution factor for the FCS in the total plant effluent (untreated) would then be 312 instead of 245.

Correspondingly, in item "a.iii" on page 71, the anticipated concentration of bromide, as the ultimate decomposition product of the FCS, in a receiving body of water would be computed as follows: 900 ppm x 1 part spent processing solution/312 parts total effluent subject to treatment before discharge x 1 part treated effluent/10 parts receiving waters of the environment = about 0.3 ppm bromide (estimated environmental concentration, EEC).

The EEC is about two-thirds of the maximum concentration likely to occur once in ten years for a food processing discharge site as reported in the Environmental Protection Agency's (EPA) evaluation for high exposure cases (1). Moreover, 95% of natural surface waters in the United States have concentrations chiefly less than 0.35 ppm bromine (2).

The concomitant salt concentrations would also be adjusted accordingly in item "a.iii" so that approximately 0.2 ppm NaCl, 0.3 ppm KCl, and 0.2 ppm CaCl2 would be the estimated concentrations in the aquatic environment.

Under item "b.i" on page 71, a cumulative concentration of bromide from discharged spent FCS was computed, but critically depended on an overarching assumption that all other water in use can be disinfected economically with the FCS at a lower concentration of 300 ppm, expressed as available molecular bromine. An error in mass conservation is repeated and yielded additional errors that were carried forward. Corrected results are as follows: 300 ppm FCS, as equivalent bromine, diluted 10-fold is 30 ppm maximum. This maximum EEC is not likely expected to occur, as stated in italics in item "b.i," because operating variables, such as economic limitations, constrain use.

Under item "b.ii," combining the anticipated effluent levels of bromide concentrations for both the lower and higher concentrations in use, as suggested in the EA's analysis to assess the cumulative impact notwithstanding the economic limitation, one arrives at 30 ppm + 0.3 ppm = about 30 ppm for the cumulative impact of total, treated, spent FCS discharged as bromide into the aquatic environment. Daphnia magna species appear to be highly sensitive reproductively to exposure from bromide (3). Exposures to 3 - 19 ppm bromide concentrations represent environmental conditions that have no observed effects (NOEC) on reproduction (p 73 of the EA). (However, EPA's ECOTOX database reports additional, long-term, general reproduction NOECs up to 91 ppm.) Experimental determinations of NOECs and their intrinsic uncertainties make the usefulness of the parameter debatable (4) even to the point that it has been recommended that NOECs be abandoned (5). Certainly, NOECs have to be very carefully used to achieve clarity in conclusions dependent upon them.

With the information provided in the EA, it bears emphasizing that the disposal from use of the FCS, as intended in FCNs 944 and 1036, appears to approach a cumulative limit with little or no margin of safety when compared to general reproduction NOEC for Daphnia magna. This is especially apparent considering that the EA for this FCN incorporates discharge data from FCN 944 (for the 300 ppm use level), thus indicating that the two concentrations are linked in a larger process. However, the cumulative EEC for bromide, about 30 ppm, is based on assumptions involving an acknowledged low probability of expectation and data having intrinsic experimental uncertainties. The meaningfulness of combining the two levels of EEC is affected by such data, the use of upper bounds to characterize use of water and other industrial operating statistics, and especially the economic assumption that all water used in all meat plants would employ exclusively the more expensive bromine-based substance as a substitute for the less expensive chlorine-based antimicrobials with which the FCS would necessarily compete. Accordingly, any future additional use resulting in increased cumulative emissions of the FCS would require that such assumptions be carefully considered and evaluated in connection with permits (National Pollutant Discharge Elimination System) for the treatment and discharge of wastewater to control excess bromide, if any, as mentioned, for example, in the concluding sentence under topic 10 of the EA.

The concentrations of possible concomitant salts, reported in item "b.iii," also need to be adjusted with the appropriate gravimetric factors to accommodate correctly the estimated maximum cumulative use of the FCS, about 30 ppm. The resulting corrected concentrations slightly increase the estimated discharges of concomitant salts and do not alter substantially the environmental effects.

Disinfection by-products belonging to the class of trihalomethanes are reasonably expected to be formed from reactions of the FCS with organic matter (carcasses) as a result of use. However, the FCS is expected to substitute chiefly for cheaper chlorine-based oxidants customarily used in commercial slaughter facilities. Substitution of one halogen-based antimicrobial for another is unlikely to alter in kind existing environmental conditions associated with irreversible ecotoxic effects from exposure, if any, to trihalomethane disinfection by-products discharged into the aquatic or soil environments because such trihalomethanes would be produced whether bromine- or chlorine-based disinfectants are used in the processing operations or in any wastewater treatment of effluents from such operations.

 

Prepared by __________________________________________Date: January 5, 2011
Leah D. Proffitt
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


(1) United States Environmental Protection Agency, Reregistration Eligibility Decision, Inorganic Halides, Case 4501, Office of Pesticide Programs, Washington, DC, 1993.

(2) See Federal Register, 59(145), 38668-38829 (July 29, 1994) at 38722-38723, which reports that the 95th percentile bromide concentration in surface water is 0.35 ppm

(3) JH Canton, PW Wester, and EAM Mathijssen-Spiekman, Food and Chemical Toxicology, 21(4), 369-378(1983), "Study on the toxicity of sodium bromide to different freshwater organisms."

(4) J Blok and F Balk, "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) then EC50 determinations.

(5) Organisation for Economic Co-operation and Development (OECD), Current Approaches in the Statistical Analysis of Ecotoxicity Data: A Guidance to Application, OECD Environmental Health and Safety Publications, Series on Testing and Assessment, No. 54, Environment Directorate, Paris, 2006.