Environmental Assessment for Food Contact Notification FCN 1986
FCN 1986: PAA, HP, AA, HEDP, SA, CAS Reg. Nos. 79-21-0, 7722-84-1, 64-19-7, 2809-21-4, and 7664-93-9, antimicrobial, meat, poultry, processed and preformed meat and poultry, brines, marinades, sauces, fish, seafood, fruits, vegetables, shell eggs.
FCN 1986: PAA, HP, AA, HEDP, SA; CAS Reg. Nos. 79-21-0, 7722-84-1, 64-19-7, 2809-21-4, and 7664-93-9; antimicrobial, meat, poultry, processed and preformed meat and poultry, brines, marinades, sauces, fish, seafood, fruits, vegetables, shell eggs.
Environmental-Assessment-for-Food-Contact-Notification-FCN-1986 Environmental Assessment for Food Contact Notification FCN 1986 https://www.fda.gov/Food, see Environmental Decisions under Ingredients and Packaging (Search FCN 1986)
LPR TECHNOLOGIES Attachment 7
FORM FDA 3480
ENVIRONMENTAL ASSESSMENT
1. Date: February 15, 2019
2. Name of Submitter: LPR Technologies
3. Correspondence Address: Beatrice Maingi 1501 E. 8th Street North Little Rock, AR 72114 Telephone: (501) 231-0247 E-mail: Beatrice@lprtech.com
4. Description of the Proposed Action
A. Requested Action
The action requested in this notification is to provide for the use of the Food Contact Substance (FCS), which is an aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide, acetic acid, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), and optionally, sulfuric acid, as an antimicrobial agent to be used:
(1) At concentrations up to 2000 ppm PAA, 800 ppm hydrogen peroxide, and 133 ppm HEDP for use in process water applied as a wash, spray, dip, rinse, chiller water, low-temperature (e.g., less than 40oF) immersion baths, or scald water for whole or cut poultry carcasses, parts, trim, and organs.
(2) At concentrations up to 1800 ppm PAA, 700 ppm hydrogen peroxide, and 120 ppm HEDP for use in process water or ice used in washing, rinsing, or cooling whole or cut meat carcasses, parts, trim, and organs.
(3) At concentrations up to 495 ppm PAA, 193 ppm hydrogen peroxide, and 33 ppm HEDP for use in process water, ice, or brine used in washing, rinsing, or cooling processed and pre-formed meat products.
(4) At concentrations up to 230 ppm PAA, 90 ppm hydrogen peroxide, and 15 ppm HEDP for use in process water, ice, or brine used in washing, rinsing, or cooling processed and pre-formed poultry products.
(5) At concentrations up to 50 ppm PAA, 17 ppm hydrogen peroxide, and 4 ppm HEDP for use in brines, marinades and sauces applied to the surface or injected into processed or unprocessed, cooked or uncooked whole or cut poultry.
(6) At concentrations up to 50 ppm PAA, 17 ppm hydrogen peroxide, and 4 ppm HEDP for use in surface sauces and marinades applied on processed and preformed meat and poultry products.
(7) At concentrations up to 230 ppm PAA, 90 ppm hydrogen peroxide, and 15 ppm HEDP for use in process water or ice used during commercial preparation of fish and seafood.
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(8) At concentrations up to 350 ppm PAA, 136 ppm hydrogen peroxide, and 23 ppm HEDP for use in process water used in washing or chilling fruits and vegetables in food processing facilities.
(9) At concentrations up to 2000 ppm PAA, 800 ppm hydrogen peroxide, and 120 ppm HEDP for use in Process water used in washing shell eggs.
Mixtures of these substances have previously been approved for the same uses, with several FCNs (No. 880, 1465, 1389, 1247, 1284, 1419, 1580, 1490, 1622, 1638,1688, 1713, 1501, 1650, 1715, 1654,1726 and 1867) permitting the use of the substances at concentrations at or above the levels proposed above.
B. Need for Action
The antimicrobial agent reduces or inhibits the growth of pathogenic and non-pathogenic microorganisms that may be present on and in food to provide safer foods for consumers.
Approval of the expanded use of the FCS will allow processors to address current needs of processors and government agencies to improve food safety. The extended concentration ranges (up to 2000 ppm PAA in poultry and up to 1800 ppm in meat) have been found to be effective in controlling Campylobacter spp. in poultry and newer species of bacteria, such as Shiga Toxin-Producing Escherichia coli (STEC) in meat. These pathogens are better controlled by exposure to higher concentrations of PAA at lower exposure times (doseresponsive rather than time-responsive). The higher concentration ranges also provide processors with more options in application methods that help better control food pathogens, such as, using high concentrations of PAA at reduced exposure times (seconds) and smaller volumes in the finishing chillers in poultry processing plants in order to treat the pathogen Campylobacter, more effectively.
The approval of the expanded use of the FCS will also allow treatment of brines, marinades and sauces used in poultry and meat plants as these solutions are often re-applied on the poultry and meat products over a period of time, typically over 4-hour intervals during an 8hour processing shift. The reused marinades, brines or sauces can cross-contaminate fresh product, and therefore treatment of these solutions is essential in eliminating such crosscontamination.
C. Locations of Use/Disposal
The antimicrobial agent is intended for use in poultry, meat, fish and seafood, fruit and vegetable, and egg processing plants throughout the United States. It may also be used aboard fishing vessels during initial evisceration and cleaning of the fresh-caught seafood.
When used in processing plants, the waste process water containing the FCS is expected to be disposed of through the processing plant wastewater treatment facilities or through a local
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publicly owned treatment works (POTW). When used aboard fishing vessels, the wastewater containing the FCS is expected to be disposed in the ocean in compliance with local fishing discharge regulations.
5. Identification of Substances that are the Subject of the Proposed Action
The Food Contact Substance is an aqueous mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidene-1,1-diphosphonic acid, and sulfuric acid. PAA formation is the result of an equilibrium reaction between acetic acid and hydrogen peroxide. The FCS is supplied in concentrated form and is diluted at the processing plant to achieve the desired level of PAA needed to address the microbial load.
The descriptions, chemical formulae, structures and molecular weights of the components are described in Table 1 below:
Table 1: Chemical Identity of Food Contact Substance Components
Component Peroxyacetic acid
CAS Number
Molecular Weight
Molecular Molecular Formula Structure
79-21-0
76.05 g/mol C2H4O3
Hydrogen peroxide 7722-84-1 34.0147 g/mol H2O2
Acetic acid
64-19-7
60.05 g/mol C2H4O2
1-hydroxyethylidene-
1,1-diphosphonic
2809-21-4
acid
206.028 g/mol C2H8O7P2
Water
7732-18-5 18.015 g/mol H2O
Sulfuric acid
7664-93-9 98.08 g/mol H2SO4
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6. Introduction of Substances into the Environment
A. Introduction of Substances into the Environment as a Result of Manufacture
As provided in 21 CFR 25.40 (a), an environmental assessment should focus on relevant environmental issues relating to the use and disposal from use, rather than the production, of FDA-regulated articles.
The FCS is manufactured in plants which meet all applicable federal, state and local environmental regulations. Notifier asserts that no extraordinary circumstances apply to the manufacture of the FCS including situations where: 1). unique emission circumstances are not adequately addressed by general or specific emission requirements (including occupational) promulgated by Federal, State or local environmental agencies and the emissions may harm the environment; 2). a proposed action threatens a violation of Federal, State or local environmental laws or requirements (40 CFR 1508.27(b)(10)); and 3). production associated with a proposed action may adversely affect a species or the critical habitat of a species determined under the Endangered Species of Wild Fauna and Flora to be endangered or threatened, or wild fauna or flora that are entitled to special protection under some other Federal law.
B. Introduction of Substances into the Environment as a Result of Use/Disposal
The FCS is supplied in concentrated form and is diluted at the processing plant. When diluted for use, the target levels of PAA in the process water for use will vary according to microbial load and type of application. The maximum at-use concentration of PAA, hydrogen peroxide (H2O2) and HEDP for each application will be as follows:
Application
Whole or cut poultry, including carcasses, parts, trim, and organs
Whole or cut meat, including carcasses, parts, trim, and organs
PAA
H2O2
HEDP
2000 ppm 800 ppm 133 ppm
1800 ppm 700 ppm 120 ppm
Processed and pre-formed meat products
Processed and pre-formed poultry products Brines, marinades and sauces applied on the surface or injected into processed or unprocessed, cooked or uncooked, whole or cut poultry
495 ppm 230 ppm
50 ppm
4
193 ppm 33 ppm 90 ppm 15 ppm
17 ppm 4 ppm
LPR TECHNOLOGIES Attachment 7
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Application Surface sauces and marinades applied on processed and preformed meat and poultry products
Fish and seafood
Fruits and vegetables
Shell eggs
PAA
H2O2 HEDP
50 ppm 230 ppm 350 ppm 2000 ppm
17 ppm 90 ppm 136 ppm 800 ppm
4 ppm 15 ppm 23 ppm 120 ppm
Treatment of the process water at the on-site wastewater treatment plant or at the POTW is expected to result in complete degradation of peroxyacetic acid, hydrogen peroxide and acetic acid, based on the half-life of these substances (described in detail in section 7 of this EA). Specifically, peroxyacetic acid will break down into oxygen and acetic acid, and hydrogen peroxide will break down into oxygen and water. Therefore, these substances are not expected to be introduced into the environment in any significant extent as a result of the proposed use of the FCS. Consequently, the remainder of this section will consider only the environmental introduction of HEDP.
As a worst-case analysis, the remainder of this EA will focus on the use profile with the highest concentration of HEDP, i.e., whole or cut poultry.
Poultry Processing Facilities
The defeathered, eviscerated carcasses in a poultry processing plant will typically be sprayed with an antimicrobial agent before being chilled in immersion chiller baths. The carcass is carried on a shackle or conveyer through a spray cabinet prior to submersion in a chiller bath. Poultry parts and organs may also be chilled by submersion in the chiller baths. Chiller baths typically include a "main chiller" bath as well as a "finishing chiller" bath, both containing an antimicrobial agent.
The FCS is diluted for use either as a spray application, or immersion application in the main chiller or finishing chiller, or in a post-chill dip for carcasses, parts, trim, or organs.
The poultry industry added finishing chillers as a response to the U.S. Department of Agriculture Food Safety and Inspection Service's (FSIS) new performance standards for Campylobacter and Salmonella.1 It is currently believed that the best control of these two pathogenic organisms occurs when Campylobacter (a dose-responsive organism) is treated at high dosage levels (up to 2000 ppm for this FCS) at a limited contact time in a finishing chiller, or by post-chill spray or dip, while Salmonella (a time-responsive organism) and other general microorganisms are treated at lower concentrations (<100 ppm) over an extended period of time in the main chiller.
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For economic feasibility, water from the finishing chiller is recycled into the main chiller waters hence maintaining the concentration of the PAA in the main chiller. This use of recycled chilling water in the main chiller is permitted under 9 CFR 416.2(g)(3). The finishing chiller will typically contain the maximum concentration of the FCS. However, since the volume of water present in the main chiller is much larger (approximately 20 times that of the finishing chiller), the FCS is significantly diluted in the main chiller. With respect to environmental impact, the contents of the main chiller will enter the wastewater treatment system and ultimately be released into the environment.
A 10-fold dilution factor accounts for the expected dilution in surface waters of effluent from an on-site wastewater treatment facility or POTW. This information is reported by Rapaport (1988).2 The environmental introduction concentrations (EIC) and expected environmental concentration (EEC) of each use is presented in Item 7 of the EA.
7. Fate of Substances Released into the Environment
As previously mentioned, treatment of the process water at the on-site wastewater treatment plant or at the POTW is expected to result in complete degradation of peroxyacetic acid, hydrogen peroxide and acetic acid. PAA and hydrogen peroxide rapidly degrade upon contact with organic matter, transition metals, and upon exposure to sunlight. According to the European Center for Ecotoxicology and Toxicology of Chemicals (ECETOC), the halflife of PAA in buffered solutions was 63 hours at pH 7 for a 748 ppm solution, and 48 hours at pH 7 for a 95 ppm solution.3 The half-life of hydrogen peroxide in natural rivers ranged from 2.5 days when initial concentration was 10,000 ppm, to 20.1 days when initial concentration decreased to 100 ppm.4 Biodegradability studies of acetic acid showed 99% degradation in 7 days under anaerobic conditions.5 Acetic acid is not expected to concentrate in the waste water discharged to POTW. In wastewater, 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.6 Therefore, peroxyacetic acid, hydrogen peroxide, acetic acid and sulfuric acid are not expected to be introduced into the environment to any significant extent as a result of the proposed use of the FCS. The remainder of this EA will therefore consider only the environmental introduction of HEDP.
The 2004 Human and Environmental Risk Assessment (HERA) reports that decomposition of HEDP contained in the discharged waste water occurs at a moderately slow pace, 33% in 28 days.7 HEDP that is removed via sedimentation or filtration slowly degrades into carbon dioxide, water and phosphates. Phosphate anions are strongly bound to organic matter and soil particles, and phosphate is a required macronutrient of plants. The HERA report estimates a half-life of HEDP in soil of 373 days. Therefore, any aquatic or soil biodegradation of HEDP is not expected to lower the estimated EEC for HEDP.
The 2004 HERA publication on phosphonate indicates that 80-90% can be expected to adsorb to wastewater sludge. Therefore, the sludge partition EICs of HEDP are calculated by multiplying the stated HEDP use level concentration by 80% (use level x 0.8). Multiplying the use level by 20% (use level x 0.2) provides the HEDP concentration remaining in
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wastewater. The expected environmental concentrations (EECs) were calculated using a conservative 10-fold dilution factor for discharge to surface waters of the effluent from an onsite treatment facility or POTW, as determined by Rapaport (Rapaport 1988). A summary of these calculations is shown below.
Application
Whole or cut poultry, including carcasses, parts, trim, and organs
HEDP
EECsludge
and EICsludgea
EIC water
EEC
waterb
133
106.4
26.6
2.66
Whole or cut meat, including carcasses, parts, trim, and organs
120
96
24
2.4
Processed and pre-formed meat products 33
26.4
6.6
0.66
Processed and pre-formed poultry products
15
12
3
0.3
Brines, marinades and sauces applied on
the surface or injected into processed or unprocessed, cooked or uncooked, whole
4
3.2
0.8
0.08
or cut poultry
Surface sauces and marinades applied on
processed and preformed meat and
4
3.2
0.8
0.08
poultry products
Fish and seafood
15
12
3
0.3
Fruits and vegetables
23
18.4
4.6
0.46
Shell eggs
120 96
24
2.4
aEIC sludge = HEDP x 80% bEEC water = (HEDP x 20%) ÷ 10 dilution
factor)
8. Environmental Effects of Released Substances
Terrestrial Toxicity According to the 2004 HERA report, HEDP in sludge is not expected to have any adverse environmental impact based on toxicity endpoints for terrestrial organisms. Specifically, HEDP shows no toxicity to terrestrial organisms (plants, earthworms, worms in soil, etc.) at levels up to 1000 mg/kg soil dry weight (No Observed Effect Concentration; NOEC). Therefore, there is no toxicity expected from land application of sludge containing 106.4 ppm HEDP.
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Aquatic Toxicity The 2004 HERA study demonstrates that toxic effects of HEDP result from chelation of nutrients, rather than direct toxicity to aquatic organisms. Chelation is not toxicologically relevant in the evaluation of the toxic effects of HEDP because eutrophication, not nutrient depletion, has been demonstrated as the controlling toxicological mode when evaluating wastewater discharges from food processing facilities.
Jaworska et al.,8 and the HERA 2004 study on phosphonates have summarized the aquatic toxicity data for HEDP as shown in the table below:
Environmental Toxicity Data for HEDP
Species
Endpoint
mg/L
Short Term
Lepomis macrochirus1
96 hr LC50
868
Oncorhynchus mykiss1
96 hr LC50
360
Cyprinodon variegates1
96 hr LC50
2180
Ictalurus punctatus1
96 hr LC50
695
Leciscus idus melanatus1
48 hr LC50
207-350
Daphnia magna1
24-48 hr EC50
165-500
Planemonetes pugio1
96 hr EC50
1770
Crassostrea virginica1
96 hr EC50
89
Selenastrum capricornutum2 96 hr EC50
3
Selenastrum capricornutum1 96 hr NOEC
1.3
Algae2
96 hr NOEC
0.74
Chlorella vulgaris1
48 hr NOEC
100
Pseudomonas putida1
30 minute NOEC 1000
Long Term
Oncorhychus mykiss1
14 day NOEC
60-180
Daphnia magna1
28 day NOEC
10- <12.5
Algae2
14 day NOEC
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1Data cited in Jaworska et al.
2Data cited in HERA Phosphonates, 2004
Jaworska et al. and HERA, 2004 found acute toxicity endpoints for HEDP ranged from 0.74 to 2180 mg/L, while chronic toxicity NOECs were 60-180 mg/L for the 14-day NOEC for Oncorhychus mykiss, and 10 - <12.5 mg/L for the 28-day NOEC for Daphnia magna. The highest short-term EC50 values reported by Jaworska et al. and HERA, 2004 for algae, Selenastrum capricornutum (3 ppm), Daphnia magna (165-500 ppm), and Crassostrea virginica (89 ppm), are considered to result from chelation effect, rather than intrinsic toxicity. Therefore, these values are not relevant in food processing wastewaters, where excess nutrients are present. The lowest relevant endpoint for food processing uses was
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determined by Jaworska et al. to be chronic NOEC of 10ppm for Daphnia magna.9 In comparison, the HEDP maximum (worst-case) EEC value of 2.66 ppm in water for the proposed use of the FCS in poultry is well below the endpoint of 10 ppm chronic NOEC for Daphnia magna.
9. Use of Resources and Energy
The notified use of the FCS will not require additional energy resources for the treatment and disposal of waste solution because the components readily degrade. The FCS is expected to compete with, and to some degree replace similar HEDP stabilized peroxy antimicrobial agents already on the market. Thus, the FCS will consume comparable amounts of energy and resources as similar products. The raw materials that are used to manufacture the FCS are commercially manufactured chemicals that are produced for use in a variety of chemical reactions and production processes. Therefore, the energy used for the production of the FCS is not significant.
10. Mitigation Measures
As discussed above, no significant adverse environmental impacts are expected to result from the use and disposal of the dilute FCS mixture. Thus, the use of the FCS as proposed does not require mitigating measures.
11. Alternatives to the Proposed Action
No adverse environmental impacts are identified herein that would necessitate alternative actions to that proposed in this Notification. The alternative of not approving the action proposed herein would result in continued use of currently marketed antimicrobial agents that the subject FCS would replace. Such action would have no significant environmental impact. The addition of the FCS to the options available to food processors is not expected to increase the use of peroxyacetic acid antimicrobial products.
12. List of Preparers
Beatrice Maingi, Senior Manager, Regulatory Affairs & QA/QC Laboratory, LPR Technologies, 1501 E. 8th Street, North Little Rock, AR 72114. M.A and B.S. in Chemistry and MBA, 9 years of experience preparing regulatory submissions to international regulatory jurisdictions, 3 years preparing regulatory submissions to FSIS.
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13. Certification The undersigned official certifies that the information presented is true, accurate, and complete to the best of the knowledge of LPR Technologies. Date: February 15, 2019 Beatrice Maingi Senior Manager, Regulatory Affairs & QA/QC Laboratory LPR Technologies
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14. References
1 USDA FSIS Federal Register Notice, "New Performance Standards for Salmonella and Campylobacter in Young Chicken and Turkey Slaughter Establishments: Response to Comments and Announcements of Implementation Schedule," 76 Fed. Reg. 15282. 2 Rapaport, Robert A., 1988. Prediction of consumer product chemical concentrations as a function of publicly owned treatment works treatment type and riverine dilution. Environmental Toxicology and Chemistry 7(2), 107115. Found online at: http://onlinelibrary.wiley.com/doi/10.1002/etc.5620070204/full 3 European Center for Ecotoxicology and Toxicology of Chemicals, JACC No. 40: Peracetic Acid and Its Equilibrium Solutions, January 2001. 4 European Center for Ecotoxicology and Toxicology of Chemicals, JACC No. 22: Hydrogen Peroxide, January 1993. 5 U.S. High Production Volume (HPV) Chemical Challenge Program: Assessment Plan for Acetic Acid and Salts Category. Acetic Acid and Salts Panel, American Chemical Council, June 28, 2001. 6 The Organization for Economic Co-operation and Development (OECD) SIDS Voluntary Testing Program for International High Production Volume Chemicals, Sulfuric Acid, 2001, available online at http://www.inchem.org/documents/sids/sids/7664939.pdf 7 HERA-Human and Environmental Risk Assessment on Ingredients of European Household Cleaning Products: Phosphonates, www.heraproject.com-Phosphonates 8Jaworska, J.; Van-Genderen-Takken, H.; Hanstveit, A.; van de Plasche, E.; Feijtel, T. Environmental risk assessment of phosphonates used in domestic laundry and cleaning agents in the Netherlands. Chemosphere 2002, 47, 655665. 9 Ibid
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