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Peracetic Acid Handling/Processing 1 2 Identification of Petitioned Substance 3 Chemical Names: CAS Numbers: 4 Peracetic acid; Ethaneperoxoic acid (IUPAC 79-21-0 5 name); Acetic peroxide; Monoperacetic acid; 89370-71-8 (historic) 6 Peroxoacetic acid; Acetyl hydroperoxide. 7 Other Codes: 8 Other Name: EC Number 201-186-8; ICSC Number 1031; 9 Peroxyacetic acid; PAA NIOSH Registry Number SD8750000; UN/ID 10 Number 3105; No INS number or E number 11 Trade Names: since peracetic acid is a sanitizer (not an 12 BioSide, Blitz, CitroBio, FreshFx, Inspexx, intentional food additive). 13 NicroBlast, Oxicure, Oxylleaf, Perasafe, 14 Peracsan, Peraclean, Per-Ox, SaniDate, Stor-Ox, 15 Tsunami, Vigor-Ox, Estosteril; Desoxone 1; 16 Dialax; Caswell no. 644, Caswell no. 644. 17 18 Summary of Petitioned Use 19 20 Peracetic acid (PAA) is currently allowed under the National Organic Program (NOP) regulations for use in 21 organic crop production, organic livestock production, and in organic food handling. This report addresses the 22 use of peracetic acid in organic processing and handling, including post-harvest handling of organically 23 produced plant and animal foods. Peracetic acid is currently allowed for use in organic handling in wash water 24 and rinse water, including during post-harvest handling, to disinfect organically produced agricultural 25 products according to FDA limitations, and to sanitize food contact surfaces, including dairy-processing 26 equipment and food-processing equipment and utensils. 27 28 29 Characterization of Petitioned Substance 30 31 Composition of the Substance: 32 Chemically, the term “peracetic acid” describes two substances. “Pure” peracetic acid, described in the Merck 33 Index (Budavari 1996), has the chemical formula C2H4O3 (alternatively written CH3CO3H). Anhydrous peracetic 34 acid explodes violently upon heating. In contrast, solutions of peracetic acid used as sanitizers are created by 35 combining aqueous mixtures of two substances: acetic acid (the acid in vinegar) and hydrogen peroxide. At 36 cool temperatures, acetic acid and hydrogen peroxide react over a few days to form an equilibrium solution 37 containing peracetic acid, acetic acid and hydrogen peroxide. This equilibrium solution is the substance sold 38 commercially as the sanitizer “peracetic acid.” Adding a mineral acid catalyst accelerates the reaction. 39 40 Peracetic acid is an unstable oxidizing agent, which is why it is such an effective sanitizer. Most commercial 41 peracetic acid solutions contain a synthetic stabilizer and chelating agent such as HEDP (1-hydroxyethylidene- 42 1, 1-diphosphonic acid) or dipicolinic acid (2,6-dicarboxypyridine) to slow the rate of oxidation or 43 decomposition. These and other additives are discussed in Combinations of the Substance. 44 45 46 Source or Origin of the Substance: 47 Pure anhydrous peracetic acid is prepared from acetaldehyde and oxygen in the presence of cobalt 48 acetate, or by the auto-oxidation of acetaldehyde (Budavari 1996). Solutions of peracetic acid, hydrogen 49 peroxide, acetic acid and water are produced by reacting glacial acetic acid with hydrogen peroxide, ___________________________________ March 3, 2016 Technical Evaluation Report Page 1 of 20 Compiled by OMRI for the USDA National Organic Program Technical Evaluation Report Peracetic Acid Handling/Processing 50 frequently in the presence of a catalyst such as a mineral acid (e.g., sulfuric acid). Specific grades are 51 obtained by controlling the concentrations and amounts of hydrogen peroxide and acetic acid during the 52 manufacturing process. Adding an acid or increasing the temperature during the manufacturing process 53 can accelerate the establishment of the final equilibrium concentration (grade). Commercial grades are 54 available in peracetic acid concentrations ranging from about 0.3 to 40 % by weight. Solutions with 55 relatively low content of acetic acid and hydrogen peroxide can be produced by distillation of the 56 equilibrium solutions. Based on the manufacturing process for sanitizing solutions of peracetic acid 57 described above, it is evident that a pure peracetic acid solution is not produced or isolated when 58 commercial peracetic acid solutions are manufactured. 59 60 A peracetic acid solution also can be generated in situ by dissolving an activator (tetra-acetyl 61 ethylenediamine) and a persalt (sodium perborate or sodium percarbonate) in water (OECD 2008), or on 62 site (within 1 minute) by adding sodium hydroxide to triacetin and hydrogen peroxide (Harvey and 63 Howarth 2013). 64 65 66 Properties of the Substance: 67 Pure anhydrous peracetic acid is a colorless liquid with a strong, pungent acrid odor. It is an organic 68 substance which is completely miscible with water (water solubility of 1000 g/L at 20 °C) and is also 69 soluble in ether, sulfuric acid and ethanol. It is a strong oxidizing agent – stronger than chlorine or 70 chlorine dioxide (Carrasco and Urrestarazu 2010). It is highly unstable and decomposes to its original 71 constituents under various conditions of temperature, concentration and pH. Peracetic acid decomposes 72 violently at 230ºF (110ºC). Peracetic acid diluted with 60% acetic acid, when heated to decomposition, 73 emits acrid smoke and irritating fumes. 74 75 Pure peracetic acid is not commercially available because it is explosive. For this reason it is not 76 technically possible to determine the melting point, boiling point and vapor pressure of pure peracetic 77 acid experimentally. Estimates based on modeling have been reported as -42 °C for melting point, about 78 105 °C for boiling point and 32 hPa at 25 °C for vapor pressure. The properties of commercial peracetic 79 acid solutions vary based on concentrations (ratios) of their components (peracetic acid, hydrogen 80 peroxide, acetic acid and water) for different grades. The physical and chemical properties of commercial 81 equilibrium grades of 5% - 35% PAA are generally consistent in composition. Their properties are shown 82 in Table 1. 83 84 Table 1. Physical and Chemical Properties of Three Equilibrium Grades of PAA (adapted from JACC 85 2001). Property Value 5% PAA 15% PAA 35% PAA Ratio of components: 5 : 22 : 10 : 63 15 : 20 : 15 : 50 35 : 7 : 40 : 18 PAA:H2O2:HOAc:H2O Freezing/Melting point -26 to -30 ºC -30 to -50 ºC -44 ºC Boiling point 99 to 105 ºC > 100 ºC > 105 ºC Density (g/cm3) at 20 ºC 1.12 1.15 1.13 Vapor pressure at 20 ºC 21 to 21 hPa 25 hPa 17 hPa Flash point (closed cup) 74 to 83 ºC 68 to 81 ºC 42 to 62 ºC Self-accelerating > 55 to > 65 ºC > 50 ºC > 55 ºC decomposition 86 87 Peracetic acid has a molecular weight of 76.05. Its dissociation constant (pKa) is 8.2 at 20 °C and, 88 therefore, the substance is mainly present in the environment as peracetic acid at a neutral pH (pH = 7), 89 while peracetate (the salt of peracetic acid) would mainly be present if the pH is significantly higher than 90 8.2 (OECD 2008). The pH of peracetic acid solutions is reported to range from < 1 to 1.8 (OECD 2008; U.S. 91 National Library of Medicine 2012; NOAA 2015). March 3, 2016 Page 2 of 20 Technical Evaluation Report Peracetic Acid Handling/Processing 92 93 94 Specific Uses of the Substance: 95 The primary use of peracetic acid is as a bactericide and fungicide, especially in food processing. The 96 current NOP regulations permit the use of peracetic acid as a disinfectant in wash water and rinse water 97 for raw and processed fruits and vegetables and meat and eggs (direct food contact) according to FDA 98 limitations, and as a sanitizer on food contact surfaces. 99 100 Peracetic acid can be utilized over a wide temperature spectrum (0 to 40ºC), in clean-in-place (CIP) 101 processes, and in carbon dioxide-saturated environments. It can also be used with hard water. In 102 addition, protein residues do not affect its efficiency. No microbial resistance to peracetic acid has been 103 reported. It is efficient over a wide spectrum of pH values, from 3.0 to 7.5 (Kunigk and Almeida 2001). 104 105 106 Regulatory Status and Approved Legal Uses of the Substance: 107 Peracetic acid is currently permitted in the NOP regulations for organic crop production, organic livestock 108 production, and organic handling, with the annotations noted below. Sections 7 CFR 205.601(m) and 205.603(e) 109 are also cited below because peracetic acid solutions contain certain inert ingredients that are essential for 110 efficacy. 111 112 7 CFR 205.601 Synthetic substances allowed for use in organic crop production. 113 (a) As algicide, disinfectants, and sanitizer, including irrigation system cleaning systems. 114 (4) Hydrogen peroxide. 115 (6) Peracetic acid—for use in disinfecting equipment, seed, and asexually propagated planting 116 material. Also permitted in hydrogen peroxide formulations as allowed in §205.601(a) at 117 concentration of no more than 6% as indicated on the pesticide product label. 118 (i) As plant disease control. 119 (5) Hydrogen peroxide. 120 (8) Peracetic acid—for use to control fire blight bacteria. Also permitted in hydrogen peroxide 121 formulations as allowed in §205.601(i) at concentration of no more than 6% as indicated on the 122 pesticide product label. 123 (m) As synthetic inert ingredients as classified by the Environmental Protection Agency (EPA) for 124 use with nonsynthetic substances or synthetic substances listed in this section and used 125 as an active pesticide ingredient in accordance with any limitations on the use of such 126 substances. 127 (1) EPA List 4 – Inerts of Minimal Concern 128 129 7 CFR 205.603 Synthetic substances allowed for use in organic livestock production. 130 (a) As disinfectants, sanitizer, and medical treatments as applicable. 131 (19) Peroxyacetic/peracetic acid (CAS #-79-21-0)—for sanitizing facility and processing 132 equipment.
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