6
Evaluation of EPA’s Approach to Setting Pathogen Standards

Treatment of domestic sewage sludge is required to minimize the risk of adverse health effects from pathogens in biosolids applied to land. In 1993, EPA published regulations establishing the processes and conditions it deemed necessary to minimize these risks. Unlike the chemical standards, the pathogen regulations are not risk-based standards but are operational standards intended to reduce the presence of pathogens to concentrations that are not expected to cause adverse health effects. The standards include treatment requirements, site restrictions, and monitoring requirements.

This chapter reviews the pathogen standards for land-applied biosolids in light of current knowledge of the potential pathogens in biosolids, how humans might be exposed to those pathogens, and factors that affect exposure (environmental fate, regional variations, and host factors). It also reviews approaches for conducting microbial risk assessments and discusses how those approaches might be used to improve EPA’s pathogens standards for biosolids. This chapter does not review health effects studies (see Chapter 3).

PATHOGEN STANDARDS

EPA established two categories of biosolids: Class A biosolids, which have no detectable concentrations of pathogens, and Class B biosolids, which have detectable concentrations of pathogens. With the goal of providing



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Biosolids Applied to Land: Advancing Standards and Practices 6 Evaluation of EPA’s Approach to Setting Pathogen Standards Treatment of domestic sewage sludge is required to minimize the risk of adverse health effects from pathogens in biosolids applied to land. In 1993, EPA published regulations establishing the processes and conditions it deemed necessary to minimize these risks. Unlike the chemical standards, the pathogen regulations are not risk-based standards but are operational standards intended to reduce the presence of pathogens to concentrations that are not expected to cause adverse health effects. The standards include treatment requirements, site restrictions, and monitoring requirements. This chapter reviews the pathogen standards for land-applied biosolids in light of current knowledge of the potential pathogens in biosolids, how humans might be exposed to those pathogens, and factors that affect exposure (environmental fate, regional variations, and host factors). It also reviews approaches for conducting microbial risk assessments and discusses how those approaches might be used to improve EPA’s pathogens standards for biosolids. This chapter does not review health effects studies (see Chapter 3). PATHOGEN STANDARDS EPA established two categories of biosolids: Class A biosolids, which have no detectable concentrations of pathogens, and Class B biosolids, which have detectable concentrations of pathogens. With the goal of providing

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Biosolids Applied to Land: Advancing Standards and Practices equivalent levels of public-health protection from pathogen exposure, EPA applied different use restrictions to each biosolids category. Class B Requirements A combination of treatment and site restrictions for Class B biosolids are intended to result in a reduction of pathogenic and indicator microorganisms (certain species of organisms believed to indicate the presence of a larger set of pathogens) to undetectable concentrations prior to public contact (Southworth 2001). Bulk biosolids applied to land must meet both treatment and use requirements (40 CFR 503.15[a]). EPA (1993) recognizes that those requirements do not necessarily consider risks to workers applying the biosolids at a site. Treatment Requirements Class B biosolids must be treated to meet one of three criteria: a fecal coliform count of less than 2×106/gram (g) of dry solids at the time of disposal, treatment by a process to significantly reduce pathogens (PSRP), or treatment by a process that is equivalent to a PSRP. In the 1993 regulations, five processes were listed as PSRPs (and thus sufficient to meet the Class B treatment requirements): Aerobic digestion at defined time and temperature combinations. Air drying for 3 months, with at least 2 months at average ambient daily temperatures above freezing. Anaerobic digestion under defined time and temperature conditions. Composting under defined time and temperature conditions. Lime stabilization so that the pH is greater than 12 after 2 h of contact. These PSRPs were selected because they result in fecal-coliform concentrations of less than 2×106/g of dry solids, and they reduce Salmonella and enteric virus concentrations by a factor of 10 (EPA 1999). The third treatment criterion requires that the permit authority approve the processes being used as equivalent to a PSRP. In practice, permit authorities have relied on the recommendations of the EPA Pathogen Equivalency Committee (PEC) (Cook and Hanlon 1993) when determining whether a particular treatment system should be designated PSRP. As of October 1999, PEC had recommended that two additional processes be designated PSRPs.

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Biosolids Applied to Land: Advancing Standards and Practices Site Restrictions The site restrictions for Class B biosolids (listed in Box 6–1) were developed on the basis of the time attenuation required to reduce the levels of pathogens (bacteria, viruses, and helminths) to below detectable concentrations at the time of public exposure (equivalent to those achieved by Class A biosolids) (Southworth 2001). The use restrictions correspond to important exposure pathways (Table 6–1). Several potential exposure routes do not appear to have been considered when those use restrictions were developed. For example, inhalation of dust was presumed to occur only on-site, and controlling access to the site was intended to prevent such inhalation. The potential for off-site exposure to wind-blown dust and aerosols does not appear to have been considered. Nor was the potential transport of pathogens in runoff from the site to neighboring properties considered. In addition, regulations require that public access to the site be restricted for either 30 days or 1 year, depending on the probability of public exposure. This restriction is vague, however, and has been interpreted by some state agencies as a requirement for posting warnings but not necessarily providing access barriers. In other contexts, such as municipal solid-waste landfills, EPA has been more specific about access controls, “Owners or operators [of landfills] must control public access…by using artificial barriers, natural barriers or both, as appropriate to protect human health and the environment” (40 CFR 258.25). Furthermore, there is no requirement that on-site measurements be taken to confirm that the treatment and site restrictions for Class B biosolids result in pathogens concentrations below detection. Class A Requirements For biosolids to be categorized as Class A with respect to pathogens, they must meet one of six criteria: Time and temperature requirements based on percentage of solids in the material. pH adjustment accompanied by high temperature and solids drying. Monitoring of enteric viruses and helminths after a treatment process to ensure below-detection concentrations. Monitoring of enteric viruses and helminths in the biosolids at the time they are distributed or applied to land. Treatment by a process for the further reduction of pathogens (PFRP).

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Biosolids Applied to Land: Advancing Standards and Practices BOX 6–1 Site Restrictions for Class B Biosolids Food crops with harvested parts that touch the biosolids/soil mixture and are totally above the land surface shall not be harvested for 14 months after application of biosolids. Food crops with harvested parts below the surface of the land shall not be harvested for 20 months after application of biosolids when the biosolids remain on the land surface for four months or longer prior to incorporation into the soil. Food crops with harvested parts below the surface of the land shall not be harvested for 38 months after application of biosolids when the biosolids remain on the land surface for less than four months prior to incorporation into the soil. Food crops, feed crops, and fiber crops shall not be harvested for 30 days after application of biosolids. Animals shall not be grazed on the land for 30 days after application of biosolids. Turf grown on land where biosolids is applied shall not be harvested for one year after application of the biosolids when the harvested turf is placed on either land with a high potential for public exposure or a lawn, unless otherwise specified by the permitting authority. Public access to land with a high potential for public exposure shall be restricted for one year after application of biosolids. Public access to land with a low potential for public exposure shall be restricted for 30 days after application of biosolids. Source: Adapted from 40 CFR 503.32(b)(5). Treatment in a process deemed equivalent to a PFRP. There are seven processes that are designated PFRPs for Class A biosolids: (a) composting with minimum time and temperature conditions, (b) heat drying with specified temperature and moisture conditions, (c) high-temperature heat treatment (no moisture content condition), (d) thermophilic aerobic digestion at specified time and temperature, (e) beta irradiation at specified dosage, (f) gamma irradiation at specified dosage, and (g) pasteurization. As with Class B biosolids, PEC has the authority to recommend to permit authorities that additional processes be designated PFRP. As of October 1999, nine additional processes were granted PFRP status by PEC (EPA 1999). The goal of the treatment processes to achieve Class A biosolids is to reduce pathogen densities to below the following detection limits for these organisms: less than 3 most probable number (MPN) per 4 g of total solids for Salmonella sp.; less than 1 plaque-forming unit (PFU) per 4 g of total solids

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Biosolids Applied to Land: Advancing Standards and Practices TABLE 6–1 Pathways of Exposure and Applicable Use Restrictions (Class B Biosolids Only) Pathways Part 503 Required Use Restriction Handling soil from fields where biosolids have been applied No public accessa to application until at least 1 year after Class B biosolids application Handling soil or food from home gardens where biosolids have been applied Class B biosolids may not be applied on home gardens Inhaling dustb No public access to application sites until at least 1 year after Class B biosolids application Walking through fields where biosolids have been appliedb No public access to fields until at least 1 year after Class B biosolids application Consuming crops from fields on which biosolids have been applied Site restrictions that prevent the harvesting of crops until environmental attenuation has taken place. Consuming milk or animal products from animals grazing on fields where biosolids have been applied No animal grazing for 30 days after Class B biosolids have been applied Ingesting surface water contaminated by runoff from fields where biosolids have been applied Class B biosolids may not be applied within 10 meters of any waters to prevent runoff from biosolids-amended land Ingesting inadequately cooked fish from water contaminated by runoff from fields where biosolids have been applied, affecting the surface water Class B biosolids may not be applied with 10 meters of any waters prevent runoff from biosolids-amended land Contact with vectors that have been in contact with biosolids All land-applied biosolids must meet one of the vector-attraction-reduction options aPublic-access restrictions do not apply to farm workers. If there is low probability of public exposure to an application site, the public-access restrictions apply for only 30 days. However, application sites that are likely to be accessed by the public, such as ballfields, are subject to 1-year public-access restrictions. bAgricultural land is private property and not considered to have a high potential for public access. Nonetheless, public-access restrictions are applied. Source: Adapted from EPA 1999.

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Biosolids Applied to Land: Advancing Standards and Practices for enteric viruses; and less than 1 viable ova per 4 g of total solids for helminths. When the Part 503 regulations were developed, Class A certification was generally based on the presence of either Salmonella or fecal coliforms (indicator bacteria) (Southworth 2001), because only a few laboratories were capable of conducting virus and helminth analyses and more time was required for these analyses (2–4 weeks). Since then, the number of laboratories capable of such analyses has increased dramatically, and analysis time has decreased. Class A pathogens requirements must be met before or at the same time that vector-attraction reduction requirements are met. For any criteria, the microbial agents are measured when the biosolids are used, disposed of, or prepared for distribution. At that time, Class A biosolids must meet one of two requirements: either the density of fecal coliforms is less than 1,000 MPN per gram of total solids or the density of Salmonella sp. is less than 3 MPN per 4 g of total solids. EPA’s Approach to Assessing Microbial Risks The Part 503 standards for pathogens were not developed using a risk-based framework, nor were they intended to be. In 1989, the Cooperative State Research Service Technical Committee W-170 (1989) reviewed the proposed Part 503 standards and stated, ”There is some concern regarding EPA’s treatment of pathogens. While it was stated that the state of the art was such that a risk assessment for pathogens was not possible, we feel that this point was glossed over rather quickly and needs greater justification.” The W-170 committee also noted that EPA was developing risk-based criteria for exposure to viruses in drinking water at the time of the proposed Part 503 standards. A few years before the Part 503 rule was proposed, EPA stated the following (Venosa 1985) on the use of PSRPs for the operative Part 257 sewage sludge regulations: For a sludge treatment process to qualify as a ‘process to significantly reduce pathogens’ (PSRP), it must produce a pathogen reduction equivalent to that obtained by a good anaerobic digestion. The logic of the definition rests on the observation that agricultural use of anaerobically digested sludge as a fertilizer has been practiced for many years with no evidence that the practice has caused human illness, provided that the digestion is adequate. Since these farming operations were on land with limited access and clearly defined use, this same restriction was applied to the use of PSRP sludge. Unfortu-

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Biosolids Applied to Land: Advancing Standards and Practices nately, this definition is not based on sound scientific information related to the survival and transport of pathogens in sludge amended soils. Further, the paucity of documented health problems associated with the land application of sludge may reflect the lack of sufficiently sensitive epidemiological tools to detect small scale incidents of disease. The committee notes, however, that the lack of such studies does not suggest that there is a risk from pathogens. The lack of a risk-assessment approach means that there is no explicit delineation of acceptable risk concentrations for Class A or Class B biosolids in the Part 503 rule. Before promulgation of the regulations, EPA funded development of preliminary risk assessments for exposure to parasites (EPA 1991a), bacteria (EPA 1991b), and viruses (EPA 1992) in biosolids. However, it is not clear to what extent these preliminary assessments were used in the development or revision of the Part 503 rule. The exposure assessments would be useful for more substantial risk-assessment development. Although a risk-based approach might have been problematic when the Part 503 rule was proposed, it is clearly an appropriate approach to use at present. A risk-based approach to assessing pathogens in biosolids offers several distinct advantages over the present framework. First, a risk-based approach would help to address the lack of sufficient epidemiological study of microbial risk from biosolids exposure. See Chapter 3 for discussion of the need for more epidemiological investigation. Second, as noted by Venosa (1985), the fundamental basis of biosolids regulations with respect to protection against pathogens rests on the assertion that, historically, agricultural use of anaerobically digested biosolids on fields (with protection from public access) results in no discernable human health effects. In promulgating the Part 503 rule for pathogens, EPA made a judgment that the treatment and disposal practices for Class A and Class B biosolids provided public-health protection equal to that of the traditional use of anaerobically digested biosolids. That judgment was in effect an implicit risk assessment. If EPA performed an explicit risk assessment, the levels of public-health protection for Class A and Class B biosolids could be more consistently compared. Third, EPA explicitly excluded risk to on-site workers from its consideration of appropriate levels of treatment. This exclusion might be particularly important for Class B biosolids, which have less stringent treatment before land application. In addition, EPA did not consider the potential for airborne and waterborne release and dispersal of microorganisms for off-site exposure (although it did consider the potential for on-site exposure to microorgan-

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Biosolids Applied to Land: Advancing Standards and Practices isms). The use of a risk-assessment approach can allow a systematic consideration of these pathways. Fourth, the basis for the EPA definitions of Class A biosolids relies on a numeric fecal coliform or Salmonella standard and a below-detection standard for viruses and helminths in a defined amount of biosolids (criteria 3 and 4). EPA reasoned that the combination of Class B treatment requirements and site-management restrictions resulted in an acceptable level of public-health protection. The use of below-detection criteria in some defined amount of biosolids originates from the use of a particular sample size in analysis (for logistical reasons). The absence of microorganisms in a small amount of material does not ensure that microorganisms are absent in a larger sample from the same source. In addition, as has been suggested in the case of re-use of wastewater for agricultural purposes, a below-detection standard might be unnecessarily stringent (Blumenthal et al. 2000). A risk-assessment approach can establish numerical limits to achieve a defined level of human health risk. Evaluation of Operational Standards Techniques for Reducing Pathogens As discussed above and in Chapter 2, techniques that combine physical, chemical, and biological processes are used to optimize pathogen reduction in biosolids. Two of the physical factors for reduction are heating and cavitation. It is difficult to examine the impact of only one physical factor, such as temperature, on reduction. Some studies have isolated temperature effects on Ascaris egg inactivation. Table 6–2 gives predicted detention times for complete (100%) inactivation of Ascaris eggs at different temperatures (Mbela 1988). At 52°C, complete inactivation of the eggs requires approximately 20 days. Inactivation with thermophilic alkaline processes and composting of biosolids requires approximately 3 to 5 days. Inactivation will also be affected by other factors such as ammonia, organic constituents, dissolved solids, and hydroxide anions (Evans and Puskas 1986; Reimers et al. 1986a). Cavitation processes are also used to inactivate resistant microorganisms. Cavitation is a term for processes that impart high mechanical energy to a fluid, resulting in local transient microzones of high temperature and pressure. Full-scale installation of such systems has not been done. However, cavitation processes, such as ultrasound or pulse power, have inactivated protozoan oocysts and assisted in enhancing anaerobic digestion processes (Reimers et al. 1985; Arrowood 1995; Patel 1996). Chemical disinfection of biosolids has been used for over 50 years. The chemicals are classified on the basis of the mode of disinfection and stabiliza-

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Biosolids Applied to Land: Advancing Standards and Practices TABLE 6–2 Detention Times for Complete Inactivation of Ascaris Eggs in Aerobic and Anaerobic Digestion Processes   Detention Time Temperature(°C) Aerobic Digestion Anaerobic Digestion 25 130 d 74 d 35 90 d 53 d 45 50 d 30 d 55 10 d 9 d 57 2 d 4 d 58 <1 h 3 d 59 <1 h 12 h 60 <1 h <1 h 70 <1 h <1 h   Source: Mbela 1988. Reprinted with permission from the author. tion (see Table 6–3). At present, only alkaline stabilization is used on a large-scale basis. Alkaline stabilization agents include lime, cement kiln dust, Portland cement, and alkaline fly ash (C-fly ash). Alkaline stabilization processes produce Class B biosolids. To yield Class A biosolids, increased temperatures or ammonia are necessary to inactivate highly resistant viruses, protozoan spores, and helminth eggs. Alkaline processes coupled with increased temperature yield a stable Class A product within 3 days. By increasing the temperature to 50°C, the effectiveness of ammonia and noncharged ammonia is increased by 5-fold and 10-fold, respectively (Bujoczek 2001). Yang (1996) confirmed this interrelationship (Table 6–4). As the solids content of the biosolids increases, the effectiveness of the alkaline disinfection increases (Yang 1996). Acid trimming enhances the exothermic reaction, because the acids generally release 10 times more heat than pulverized quicklime. Biological processing has been effective in the digesting, composting, and storage of biosolids. In these processes, there is mechanical or autothermal heating. Biocidal inactivation has been observed in lagoon storage. Anaerobic biosolids required 40% less inactivation time than aerobic biosolids, although above 50–55°C, thermal inactivation is predominant. Furthermore, as the solids content of anaerobic biosolids increases, the inactivation rates increase. An increase in solids from 4% to 24% resulted in a 5-fold increase in parasite and bacteria die-off and a 25-fold increase in virus die-off. Soils tend to reduce the rate of die-off of parasites and viruses by 3 to 5 times in nontreated

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Biosolids Applied to Land: Advancing Standards and Practices TABLE 6–3 Chemicals Used for Disinfecting Biosolids Alkaline Agents Acid Trimming Agents ORP Controlling Agents Noncharged Disinfectants Lime Cement kiln dust Sulfuric acid Nitric acid Ozone Peroxide Ammonia (alkaline treatment) Portland cement alkaline Fly ash Phosphoric acid sulfamic acid   Amines (alkaline treatment and composting) Silicates Spent bauxite hydroxide anions   Organic acids, aldehydes, and ketones (anaerobic digestion and composting)   Nitrous acid (acidic treatment) Abbreviation: ORP, oxidation reduction potential Source: Reimers et al. 1999. Reprinted with permission from the author. or lagoon-stored biosolids (Reimers et al. 2001). The impacts of pathogen inactivation factors on biosolids processing are shown in Table 6–5. Reliability of Processes In assessing the risk associated with biosolids management, the reliability of the treatment processes is important to consider, because adverse effects might result from a single exposure to an infectious agent. Reliability may be defined as the frequency (or probability) at which a certain concentration or lower of a pathogen is attained in the effluent of a process. To assess the risk distribution from pathogen disinfection processes, data collection is required. As an example, Figure 6–1 presents the probability distribution for virus and helminth counts in raw sewage sludge at the Metropolitan Water Reclamation District of Greater Chicago (Lue-Hing et al. 1998). The treatment sequence included anaerobic digestion, dewatering, and long-term lagoon storage. All treated virus samples were below detection. The data are plotted using a Kaplan-Meir approach to impute values for the below-detection samples. For example, in the finished solids, 95% of the time the helminth concentrations were below 0.05 organisms per 4 g of solids. In setting standards, both the typical (e.g., mean) performance and the proportion of time that a specific numerical level is exceeded are appropriate

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Biosolids Applied to Land: Advancing Standards and Practices TABLE 6–4 Relationship Between Ammonia Concentration and Temperature in Ascaris Inactivation   Ammonia Dosage for Ascaris Inactivation (days) Temperature 0.1% 1.0% 4.0% 25°C 180 10 <1 35°C 10 3 <1 52°C <1 <1 <1   Source: Data from Yang 1996. metrics to be considered. For example, EPA-recommended water-quality criteria for micoorganisms in recreational waters are specified according to geometric mean levels (over 7 d) and not-to-exceed levels. No such metrics have been established for pathogens in biosolids. Reliability of Use Controls For Class B biosolids, use requirements (described earlier in Box 6–1) are relied on as impediments to exposure, at least for the general public. The resulting risk reductions can be assessed if the pathogen die-off rates are known and if the degree to which the use controls prevent exposure are known. Unfortunately, the reliability of these controls has not been studied on a systematic basis. PATHOGENS IN BIOSOLIDS Four major types of human pathogens can be found in biosolids: bacteria, viruses, protozoa, and helminths. EPA reviewed a broad spectrum of these agents in establishing its biosolids standards. Some of the principal pathogens considered by EPA are listed in Box 6–2. Since the development of the Part 503 rule, many new pathogens have been recognized, and the importance of others has increased. A selection of these pathogens are discussed below. It must be noted that despite the ability to isolate pathogens from raw sewage sludge and partially and fully treated biosolids, the mere isolation of pathogens does not in and of itself indicate that a risk exists. There are no scientifically documented outbreaks or excess illnesses that have occurred from microorganisms in treated biosolids. As will be discussed in detail later, risk is a function of the level of exposure, not simply the occurrence of an organism per se.

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