5
Evaluation of EPA’s Approach to Setting Chemical Standards

The U.S. Environmental Protection Agency used risk-assessment methods to set biosolids chemical standards (termed “pollutant limits” under the Part 503 rule) to be protective of human health and the environment. Risk-based standards are generally maximum levels that should not be exceeded. Risks experienced by a typical receptor population are likely to be lower, and in most cases, much lower than target risk levels used to derive risk-based standards. However, the protectiveness of the risk-based standards is dependent on the data and methods used to establish the standards, as well as on compliance with specified conditions of use.

The risk-assessment methods for establishing the Part 503 rule were developed in the mid-1980s. Since that time, EPA has refined risk-assessment methods and approaches and has issued a number of guidance documents to support standardized approaches to risk assessment (see Chapter 4). In this chapter, the methods used for the Part 503 rule risk assessments are reevaluated in light of the current practice of risk assessment. Specific assumptions made in the risk assessments are also reevaluated on the basis of available scientific information.

Risk assessments typically include four steps: hazard identification, exposure assessment, toxicity (dose-response) assessment, and risk characterization (NRC 1994). Elements of all four steps are considered in the following sections. The first section considers the hazard-identification approach used to select chemicals for inclusion in the risk assessment (EPA 1985, 1992a,b). Subsequent sections address general issues for exposure assessment and risk



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Biosolids Applied to Land: Advancing Standards and Practices 5 Evaluation of EPA’s Approach to Setting Chemical Standards The U.S. Environmental Protection Agency used risk-assessment methods to set biosolids chemical standards (termed “pollutant limits” under the Part 503 rule) to be protective of human health and the environment. Risk-based standards are generally maximum levels that should not be exceeded. Risks experienced by a typical receptor population are likely to be lower, and in most cases, much lower than target risk levels used to derive risk-based standards. However, the protectiveness of the risk-based standards is dependent on the data and methods used to establish the standards, as well as on compliance with specified conditions of use. The risk-assessment methods for establishing the Part 503 rule were developed in the mid-1980s. Since that time, EPA has refined risk-assessment methods and approaches and has issued a number of guidance documents to support standardized approaches to risk assessment (see Chapter 4). In this chapter, the methods used for the Part 503 rule risk assessments are reevaluated in light of the current practice of risk assessment. Specific assumptions made in the risk assessments are also reevaluated on the basis of available scientific information. Risk assessments typically include four steps: hazard identification, exposure assessment, toxicity (dose-response) assessment, and risk characterization (NRC 1994). Elements of all four steps are considered in the following sections. The first section considers the hazard-identification approach used to select chemicals for inclusion in the risk assessment (EPA 1985, 1992a,b). Subsequent sections address general issues for exposure assessment and risk

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Biosolids Applied to Land: Advancing Standards and Practices characterization. These sections are followed by a discussion of issues relevant to specific inorganic and organic chemicals, including toxicity assessment. HAZARD ASSESSMENT AND CHEMICAL SELECTION To date, EPA has conducted two rounds of assessments to identify chemicals to regulate in the Part 503 rule. Round 1 was conducted to identify an initial set of chemical pollutants to regulate, and Round 2 was conducted to identify additional pollutants for regulation. Standards for the Round 2 pollutants have not been established, but EPA is considering regulation of dioxins (a category of compounds that has 29 specific congeners of polychlorinated dibenzo-p-dioxins, polychlorinated dibenzofurans, and coplanar polychlorinated biphenyls) for land application. Therefore, although evaluation of EPA’s dioxin risk assessments for biosolids is outside the scope of the committee’s charge, the committee believes that evaluating the selection of dioxins for regulation is within the charge. Round 1 Pollutant Selection EPA used a two-stage process to select its initial set of contaminants to regulate under the Part 503 rule. First, a list of chemicals was subjected to a hazard screening. Second, chemicals found to represent a potentially significant risk were subject to formal risk assessment. In 1984, using available data on effects in humans, plants, domestic animals, wildlife, and aquatic organisms and frequency of chemical occurrence in biosolids, EPA identified 200 potential chemicals of concern in biosolids. A panel of scientific experts selected 50 chemicals of potential concern for evaluation by EPA. A screening process was then used to select 22 pollutants for potential regulation (Table 5–1). The process involved developing environmental profiles for each pollutant for which data were readily available on toxicity, occurrence, fate, and pathway-specific hazards. When relevant, aggregate cancer risks from exposure via several pathways were assessed. Risks posed by some of the pathways subsequently analyzed in the risk assessment were not used in the screening process (pathways 11–14, see Table 5–4 in summary of exposure pathways). To determine whether a full risk assessment was warranted for a particular chemical via a specific exposure pathway, a hazard index was calculated for each contaminant and pathway that had sufficient data (EPA 1985). This index is the ratio of the estimated concentration of the pollutant in the envi-

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Biosolids Applied to Land: Advancing Standards and Practices TABLE 5–1 Pollutants Selected for Potential Regulation Inorganic Chemicals Organic Chemicals Arsenic Aldrin and dieldrin Cadmium Benzo[a]pyrene Chromium Chlordane Copper DDT, DDD, DDE Lead Heptachlor Mercury Hexachlorobenzene Molybdenum Hexachlorobutadiene Nickel Lindane Selenium N-Nitrosodimethylamine Zinc Polychlorinated biphenyls   Toxaphene   Trichloroethylene Abbreviations: DDT, 1,1,1-trichloro-2,2-bis(p-chlorophenyl)ethane; DDE, 1,1-dichloro-2,2-bis(p-chlorophenyl)ethylene; DDD, 1,1-dichloro-2,2-bis(p-chlorophenyl)-ethane. Source: EPA 1992a. ronment (soil, plant or animal tissue, water, or air) to the established human health or other regulatory criteria (e.g., acceptable daily intake for noncarcinogens or a cancer risk-specific intake). The calculated soil concentrations were based on “typical” and “worst” concentrations of the contaminant found in biosolids and were evaluated at application rates of 5 and 50 metric tons per hectare (mt/ha) and a cumulative application of 500 mt/ha based on the assumption of 5 mt/ha per year for 100 years. Data on concentrations of pollutants in sewage sludge were obtained primarily from survey data collected in a 40-city study (EPA 1982). Median values were used to represent typical concentrations, and the 95th percentile was used to represent the worst-case concentrations. It is not clear how calculations on typical concentrations and low application rates were used in the screening process, because the hazard index was reportedly derived using worst-case conditions. After the screening process, pollutants with a hazard index equal to or greater than 1 were evaluated further. The hazard index for each of these pollutants was adjusted so that it reflected the hazard attributable only to

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Biosolids Applied to Land: Advancing Standards and Practices biosolids for the specific pathway of exposure being evaluated. This adjustment was done by excluding background exposure to the pollutant from sources other than biosolids. When adjusted values exceeded 1, the pollutant was evaluated for that particular pathway in a detailed risk assessment. Thus, background exposure was eliminated, and only pollutants for which the hazard index was greater than 1 for the increment contributed by biosolids were subjected to further analysis through risk assessment. This analysis assessed exposure via each pathway to each chemical. For human-health-related pathways, this procedure resulted in the elimination of fluoride and lindane from consideration in several pathways. After the proposed Part 503 rule was issued in 1989, EPA completed a National Sewage Sludge Survey (NSSS) (EPA 1990). The NSSS collected data on more than 400 pollutants from approximately 180 sewage treatment plants throughout the country to produce national estimates of concentrations of pollutants in sewage sludge. Using the NSSS data and information from the risk assessments, EPA conducted a further screening analysis to eliminate from regulation any pollutant that was not present at concentrations deemed to pose a significant public health or environmental risk. On the basis of this screening analysis, the 12 organic chemicals were exempted, leaving only inorganic chemicals for regulation by the Part 503 rule. The following criteria for exempting organic pollutants were used: The pollutant has been banned from use, has restricted use, or is no longer manufactured for use in the United States. The pollutant has a low frequency of detection in sewage sludge (less than 5%) based on data from the NSSS. The concentration of the pollutant in sewage sludge is already low enough that the estimated annual loading to cropland soil would result in an annual pollutant-loading rate within allowable risk-based levels. Aldrin and dieldrin; chlordane; 1,1,1-trichloro-2,2-bis(p-chlorophenyl)ethane, 1,1-dichloro-2,2-bis(p-chlorophenyl)ethylene, 1,1-dichloro-2,2-bis(p-chlorophenyl)ethane (DDT, DDE, DDD); heptachlor; lindane; N-nitrosodimethylamine; polychlorinated biphenyls (PCBs); and toxaphene were eliminated on the basis of criterion 1. All the organics except aldrin and dieldrin, bis(2-ethylhexyl)phthalate, and PCBs met criterion 2. On the basis of agricultural application assumptions, all the organics except benzo[a]pyrene, hexachlorobenzene, N-nitrosodimethylamine, and PCBs met criterion 3. Under different application scenarios, some of these same organics might not meet criterion

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Biosolids Applied to Land: Advancing Standards and Practices 3. For example, EPA (1992b) noted that under scenarios for applications to forests and public contact sites, toxaphene and the organics eliminated under the agricultural scenario do not meet criterion 3. Round 2 Pollutant Selection Subsequent to the promulgation of biosolids regulations in 1993, another evaluation was conducted to develop a list of Round 2 pollutants to consider for regulation (EPA 1996a). As with the Round 1 pollutants, EPA conducted a preliminary hazard identification followed by a risk assessment for those contaminants and pathways identified as potential hazards. In this evaluation, degradation products of organic contaminants were assumed to be nontoxic. The list of 411 pollutants analyzed in the NSSS (EPA 1990) was the starting point of the Round 2 assessments. Pollutants were eliminated from consideration if they were not detected (254 pollutants) or were detected in less than 10% of sewage sludge (69 pollutants). Pollutants present in more than 10% of sewage sludge but with insufficient toxicity data were also eliminated from Round 2 consideration (see Table 5–2). Some of these chemicals lack toxicity values due to a relative lack of toxicity. Several pollutants were grouped into classes of congeners (e.g., PCBs, chlorinated dioxins, and furans). The screening process identified 30 pollutants that had a frequency of detection of 10% or greater in the NSSS and that had data on human health and/or ecological toxicity (Table 5–3). Asbestos, which was not analyzed in the NSSS, was added as another potential candidate for regulation because it is toxic, persistent, and can be in biosolids. These 31 pollutants were subject to further analysis in a comprehensive hazard identification study. The study used a mix of conservative and average value assumptions similar to those used in the Round 1 risk assessments. The aggregate exposure through more than one pathway was not assessed. Analysis of a particular pathway of exposure for certain candidate chemicals was not conducted when EPA determined that chemical-specific data were insufficient for that pathway. The result of the evaluation was that only dioxins, furans, and coplanar PCBs (considered as a group) were subject to further risk assessment (EPA 1996a). That risk assessment led to a proposed standard in December 1999 (EPA 1999a). EPA sponsored a peer review of that risk assessment and proposed standard (Versar 2000). On the basis of review comments and the agency’s reassessment of dioxin risks, EPA decided to revise the risk assessment. A peer-review draft was released November 30, 2001 (EPA 2001a), and a notice of data availability was subsequently issued for public comment on June 12, 2002 (EPA 2002).

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Biosolids Applied to Land: Advancing Standards and Practices TABLE 5–2 Chemicals Eliminated from Consideration in the Round 2 Assessments Because of Lack of Toxicity Data Calcium Magnesium Decane, n- Octacosane, n- Dodecane, n- Sodium Eicosane, n- Tetracosane, n- Hexacosane, n- Tetradecane, n- Hexadecane, n- Triacontane, n- Hexanoic acid Yttrium Iron     Source: EPA 1996a. Limitations of the Assessment and Selection Process Survey Data Accurate data on pollutant concentrations in biosolids are crucial to the selection of chemicals to regulate under the Part 503 rule. Many of the decisions made in the chemical selection process were based on concentration data from the NSSS (EPA 1990). The NSSS was an ambitious undertaking and provides the most comprehensive data on the content of sewage sludge in the United States to date. However, the survey was conducted over a decade ago, and there is a need to conduct a new survey to characterize the concentrations and distribution of chemicals now present in biosolids. For example, state survey data presented in Chapter 2 show that concentrations of some of the regulated inorganic elements have generally decreased over the past decade. Furthermore, the accuracy of the NSSS data was called into question by an earlier NRC committee that was asked to evaluate the use of biosolids on croplands (NRC 1996). That committee found inconsistencies in the survey’s sampling analyses and data-reporting methods that undermined the reliability of the data. Therefore, it recommended that another comprehensive survey be conducted to rectify the NSSS’s sampling and analytical limitations. To date, no such survey has been done. Some chemicals that were undetected because of analytical problems or detection limits that exceeded risk-based concentrations were likely eliminated mistakenly. Each of the chemicals in the NSSS was assigned a “detection limit,” which was equivalent to the minimum concentration of pollutant that could be quantitated (EPA 1990). The detection limits are difficult to discern

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Biosolids Applied to Land: Advancing Standards and Practices TABLE 5–3 Candidate Pollutants for Round 2 Regulationsa Acetic acid (2,4-dichlorophenoxy) Methylene chloride Aluminumb Nitrate Antimony Nitrite Asbestosc Pentachloronitrobenzene Barium Phenol Beryllium Polychlorinated biphenyls-coplanar Bis(2-ethylhexyl)phthalate Propanone, 2- Boron Propionic acid, 2-(2,4,5-trichlorophenoxy) Butanone, 2- Silver Carbon disulfide Thallium Cresol, p- Tin Cyanides (soluble salts and complexes) Titanium Dioxins and dibenzofurans Toluene Endosulfan-II Trichlorophenoxyacetic acid, 2,4,5- Fluoride Vanadium Manganese aPollutants detected at a frequency of at least 10% with human health and/or ecological toxicity data available. bAluminum does not have human health or ecological toxicity data available but is included because of its potential for phytotoxicity. cAsbestos was not tested in the NSSS but is toxic, persistent, and can be in sewage sludge. Source: EPA 1996a. from the NSSS data, and actual detection limits for a given chemical varied over a wide range of concentrations among samples (Figures 5–1 through 5–4). Data presented in the technical support document for the Round 2 assessment (EPA 1996a) indicated that some detection limits exceeded several hundred parts per million for some of the organic chemicals. At the request of the committee, detection limits of NSSS samples for eight chemicals, four of which were not detected in the NSSS (ideno[1,2,3-cd]pyrene, N-nitrosodimethylamine, pentachlorophenol, and toxaphene), were provided by EPA (Charles White, EPA, personal communication, February 2001). Before conducting a risk assessment, the adequacy of the available chemical concentration data to support the risk assessment is typically evaluated (EPA 1991). It is

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Biosolids Applied to Land: Advancing Standards and Practices FIGURE 5–1 Detected concentrations (▲) and detection limits (×) for nondetects (as a function of solids content of sewage sludge) compared with siol screening levels (A, ingestion and dermal; B, inhalation) for hexachlorobenzene and mercury. Source: NSSS data from EPA 1990.

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Biosolids Applied to Land: Advancing Standards and Practices FIGURE 5–2 Detected concentrations (▲) and detection limits (×) for nondetects (as a function of solids content of sewage sludge) compared with soil screening levels (A, ingestion and dermal) for indeno(1,2,3-cd)pyrene and PCB-1254. Source: NSSS data from EPA 1990.

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Biosolids Applied to Land: Advancing Standards and Practices FIGURE 5–3 Detected concentrations (▲) and detection limits (×) for nondetects (as a function of solids content of sewage sludge) compared with soil screening levels (A, ingestion and dermal) for toxaphene and pentachlorophenol. Source: NSSS data from EPA 1990.

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Biosolids Applied to Land: Advancing Standards and Practices FIGURE 5–4 Detected concentrations (▲) and detection limits (×) for nondetects (as a function of solids content of sewage sludge) compared with the soil screening levels for dieldrin and the EPA Region 9 preliminary remediation goal (A, ingestion and dermal) and for N-nitrosodimethylamine (B, ingestion) (EPA 2002b). Note: The PRG for N-nitrosodimethylamine is approximately 1 µg/kg, and could not be shown grapically on the figure. Source: NSSS data from EPA 1990.

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