Roberta L. Grant

Toxicity Evaluation and Human Health Risk Assessment of Surface and Ground Water Contaminated by Recycled Hazardous Waste Materials

Prior to the 1970s, principles involving the fate and transport of hazardous chemicals from either hazardous waste spills or landfills into ground water and/or surface water were not fully understood. In addition, national guidance on proper waste disposal techniques was not well developed. As a result, there were many instances where hazardous waste was not disposed of properly, such as the Love Canal environmental pollution incident. This incident led to the passage of the Resource Conservation and Recovery Act (RCRA) of 1976. This act gave the United States Environmental Protection Agency regulatory control of all stages of the hazardous waste management cycle. Presently, numerous federal agencies provide guidance on methods and approaches used to evaluate potential health effects and assess risks from contaminated source media, i.e., soil, air, and water. These agencies also establish standards of exposure or health benchmark values in the different media, which are not expected to produce environmental or human health impacts. The risk assessment methodology is used by various regulatory agencies using the following steps: i) hazard identification; ii) dose-response (quantitative) assessment; iii) exposure assessment; iv) risk characterization. The overall objectives of risk assessment are to balance risks and benefits; to set target levels; to set priorities for program activities at regulatory agencies, industrial or commercial facilities, or environmental and consumer organizations; and to estimate residual risks and extent of risk reduction. The chapter will provide information on the concepts used in estimating risk and hazard due to exposure to ground and surface waters contaminated from the recycling of hazardous waste and/or hazardous waste materials for each of the steps in the risk assessment process. Moreover, this chapter will provide examples of contaminated water exposure pathway calculations as well as provide information on current guidelines, databases, and resources such as current drinking water standards, health advisories, and ambient water quality criteria. Finally, specific examples of contaminants released from recycled hazardous waste materials and case studies evaluating the human health effects due to contamination of ground and surface waters from recycled hazardous waste materials will be provided and discussed.

A Chronic Reference Value for 1,3-Butadiene Based on an Updated Noncancer Toxicity Assessment

A chronic noncancer toxicity assessment for 1,3-butadiene (BD) has been conducted by the Texas Commission on Environmental Quality (TCEQ) using information not available to the U.S. Environmental Protection Agency (U.S. EPA) in 2002. The TCEQ developed a chronic reference value (ReV) of 33 μg/m3 (15 ppb). The chronic ReV is based on the same animal study and critical endpoint used by U.S. EPA for ovarian atrophy in B6C3F1 mice, but uses mode of action (MOA) information that indicates the diepoxide metabolite is responsible for ovarian atrophy. In addition, diepoxide-specific hemoglobin adduct data in mice, rats, and humans and other experimental data that became available after 2002 were used to support a conservative data-derived toxicokinetic animal-to-human uncertainty factor (UFA) of 0.3. The default toxicodynamic UFA of 3 was used, together with the data-derived toxicokinetic UFA of 0.3, resulting in a total UFA of 1. The necessary experimental data were not available to calculate a chemical-specific adjustment factor, although supporting data suggest the toxicokinetic UFA may range from 0.01 to 0.2. The chronic ReV value, along with a unit risk factor developed by the TCEQ, will be used to evaluate ambient air monitoring data so that the general public is protected against adverse health effects from chronic exposure to BD.

An updated inhalation unit risk factor for arsenic and inorganic arsenic compounds based on a combined analysis of epidemiology studies

The United States Environmental Protection Agency (USEPA) developed an inhalation unit risk factor (URF) of 4.3E-03 per μg/m(3) for arsenic in 1984 for excess lung cancer mortality based on epidemiological studies of workers at two smelters: the Asarco smelter in Tacoma, Washington and the Anaconda smelter in Montana. Since the USEPA assessment, new studies have been published and exposure estimates were updated at the Asarco and Anaconda smelters and additional years of follow-up evaluated. The Texas Commission on Environmental Quality (TCEQ) has developed an inhalation URF for lung cancer mortality from exposures to arsenic and inorganic arsenic compounds based on a newer epidemiology study of Swedish workers and the updates of the Asarco and Anaconda epidemiology studies. Using a combined analysis approach, the TCEQ weighted the individual URFs from these three epidemiology cohort studies, to calculate a final inhalation URF of 1.5E-04 per μg/m(3). In addition, the TCEQ also conducted a sensitivity analysis, in which they calculated a URF based on a type of meta-analysis, and these results compared well with the results of the combined analysis. The no significant concentration level (i.e., air concentration at 1 in 100,000 excess lung cancer mortality) is 0.067μg/m(3). This value will be used to evaluate ambient air monitoring data so the general public in Texas is protected against adverse health effects from chronic exposure to arsenic.

Emissions and ambient air monitoring trends of lower olefins across Texas from 2002 to 2012

Texas has the largest ambient air monitoring network in the country with approximately 83 monitoring sites that measure ambient air concentrations of volatile organic compounds (VOCs). The lower olefins, including 1,3-butadiene, ethylene, isoprene, and propylene, are a group of VOCs that can be measured in both 24h/every sixth-day canister samples and continuous 1-h Automated Gas Chromatography (AutoGC) samples. Based on 2012 Toxics Release Inventory data, the total reported industrial air emissions in Texas for these olefins, as compared to total national reported air emissions, were 79% for 1,3-butadiene, 62% for ethylene, 76% for isoprene, and 54% for propylene, illustrating that Texas industries are some of the major emitters for these olefins. The purpose of this study was to look at the patterns of annual average air monitoring data from 2002 to 2012 using Texas Commission on Environmental Quality (TCEQ) data for these four lower olefins. It should be emphasized that monitors may not be located close to or downwind of the highest emitters of these lower olefins. In addition, air monitors only provide a snapshot in time of air concentrations for their respective locations, and may not be able to discriminate emissions between specific sources. In 2012, the highest annual average air concentration for 1,3-butadiene was 1.28 ppb by volume (ppbv), which was measured at the Port Neches monitoring site in Region 10-Beaumont. For ethylene, the highest 2012 annual average air concentration was 5.77 ppbv, which was measured at the Dona Park monitoring site in TCEQ Region 14-Corpus Christi. Although reported industrial emissions of isoprene are predominantly from the Houston and Beaumont regions, trees are natural emitters of isoprene, and the highest ambient air concentrations tend to be from regions with large areas of coniferous and hardwood forests. This was observed with TCEQ Region 5-Tyler, which had the two highest isoprene annual average air concentrations for 2012: 0.56 ppbv at the Karnack monitoring site and 0.47 ppbv at the Longview monitoring site. For propylene, the highest 2012 annual average air concentration was recorded at the HRM 7 monitoring site in TCEQ Region 12-Houston, which was 7.9 ppbv. A significant portion of the total 2012 industrial propylene emissions were also reported in TCEQ Region 12-Houston. Although some individual monitors showed increased annual averages from 2002 to 2012, there was a general decreasing trend present across the state for all four lower olefins examined. The annual average air concentrations of the four lower olefins were well below their respective Air Monitoring Comparison Values (AMCVs) and are not expected to cause long-term or chronic adverse health effects.

Development of a Unit Risk Factor for 1,3‐Butadiene Based on an Updated Carcinogenic Toxicity Assessment

The Texas Commission on Environmental Quality (TCEQ) has developed an inhalation unit risk factor (URF) for 1,3-butadiene based on leukemia mortality in an updated epidemiological study on styrene-butadiene rubber production workers conducted by researchers at the University of Alabama at Birmingham. Exposure estimates were updated and an exposure estimate validation study as well as dose-response modeling were conducted by these researchers. This information was not available to the U.S. Environmental Protection Agency when it prepared its health assessment of 1,3-butadiene in 2002. An extensive analysis conducted by TCEQ discusses dose-response modeling, estimating risk for the general population from occupational workers, estimating risk for potentially sensitive subpopulations, effect of occupational exposure estimation error, and use of mortality rates to predict incidence. The URF is 5.0 x 10(-7) per microg/m(3) or 1.1 x 10(-6) per ppb and is based on a Cox regression dose-response model using restricted continuous data with age as a covariate, and a linear low-dose extrapolation default approach using the 95% lower confidence limit as the point of departure. Age-dependent adjustment factors were applied to account for possible increased susceptibility for early life exposure. The air concentration at 1 in 100,000 excess leukemia mortality, the no-significant-risk level, is 20 microg/m(3) (9.1 ppb), which is slightly lower than the TCEQ chronic reference value of 33 microg/m(3) (15 ppb) protective of ovarian atrophy. These values will be used to evaluate ambient air monitoring data so the general public is protected against adverse health effects from chronic exposure to 1,3-butadiene.

Approaches for describing and communicating overall uncertainty in toxicity characterizations: U.S. Environmental Protection Agency's Integrated Risk Information System (IRIS) as a case study.

Single point estimates of human health hazard/toxicity values such as a reference dose (RfD) are generally used in chemical hazard and risk assessment programs for assessing potential risks associated with site- or use-specific exposures. The resulting point estimates are often used by risk managers for regulatory decision-making, including standard setting, determination of emission controls, and mitigation of exposures to chemical substances. Risk managers, as well as stakeholders (interested and affected parties), often have limited information regarding assumptions and uncertainty factors in numerical estimates of both hazards and risks. Further, the use of different approaches for addressing uncertainty, which vary in transparency, can lead to a lack of confidence in the scientific underpinning of regulatory decision-making. The overarching goal of this paper, which was developed from an invited participant workshop, is to offer five approaches for presenting toxicity values in a transparent manner in order to improve the understanding, consideration, and informed use of uncertainty by risk assessors, risk managers, and stakeholders. The five approaches for improving the presentation and communication of uncertainty are described using U.S. Environmental Protection Agencys (EPAs) Integrated Risk Information System (IRIS) as a case study. These approaches will ensure transparency in the documentation, development, and use of toxicity values at EPA, the Agency for Toxic Substances and Disease Registry (ATSDR), and other similar assessment programs in the public and private sector. Further empirical testing will help to inform the approaches that will work best for specific audiences and situations.

Impact of three interactive Texas state regulatory programs to decrease ambient air toxic levels.

The Federal Clean Air Act (FCAA) framework envisions a federal-state partnership whereby the development of regulations may be at the federal level or state level with federal oversight. The U.S. Environmental Protection Agency (EPA) establishes National Ambient Air Quality Standards to describe “safe” ambient levels of criteria pollutants. For air toxics, the EPA establishes control technology standards for the 187 listed hazardous air pollutants (HAPs) but does not establish ambient standards for HAPs or other air toxics. Thus, states must ensure that ambient concentrations are not at harmful levels. The Texas Clean Air Act authorizes the Texas Commission on Environmental Quality (TCEQ), the Texas state environmental agency, to control air pollution and protect public health and welfare. The TCEQ employs three interactive programs to ensure that concentrations of air toxics do not exceed levels of potential health concern (LOCs): air permitting, ambient air monitoring, and the Air Pollutant Watch List (APWL). Comprehensive air permit reviews involve the application of best available control technology for new and modified equipment and ensure that permits protect public health and welfare. Protectiveness may be demonstrated by a number of means, including a demonstration that the predicted ground-level concentrations for the permitted emissions, evaluated on a case-by-case and chemical-by-chemical basis, do not cause or contribute to a LOC. The TCEQs ambient air monitoring program is extensive and provides data to help assess the potential for adverse effects from all operational equipment in an area. If air toxics are persistently monitored at a LOC, an APWL area is established. The purpose of the APWL is to reduce ambient air toxic concentrations below LOCs by focusing TCEQ resources and heightening awareness. This paper will discuss examples of decreases in air toxic levels in Houston and Corpus Christi, Texas, resulting from the interactive nature of these programs. Implications: Texas recognized through the collection of ambient monitoring data that additional measures beyond federal regulations must be taken to ensure that public health is protected. Texas integrates comprehensive air permitting, extensive ambient air monitoring, and the Air Pollutant Watch List (APWL) to protect the public from hazardous air toxics. Texas issues air permits that are protective of public health and also assesses ambient air to verify that concentrations remain below levels of concern in heavily industrialized areas. Texas developed the APWL to improve air quality in those areas where monitoring indicates a potential concern. This paper illustrates how Texas engaged its three interactive programs to successfully address elevated air toxic levels in Houston and Corpus Christi.

Development of a unit risk factor for nickel and inorganic nickel compounds based on an updated carcinogenic toxicity assessment

The TCEQ has developed a URF for nickel based on excess lung cancer in two epidemiological studies of nickel refinery workers with nickel species exposure profiles most similar to emissions expected in Texas (i.e., low in sulfidic nickel). One of the studies (Enterline and Marsh, 1982) was used in the 1986 USEPA assessment, while the other (Grimsrud et al., 2003) is an update to an earlier study (Magnus et al., 1982) used by USEPA. The linear multiplicative relative risk model with Poisson regression modeling was used to obtain maximum likelihood estimates and asymptotic variances for cancer potency factors (β) using cumulative nickel exposure levels versus observed and expected lung cancer mortality (Enterline and Marsh, 1982) or lung cancer incidence cases (Grimsrud et al., 2003). Life-table analyses were then used to develop URFs from these two studies, which were combined using weighting factors relevant to confidence to derive the final URF for nickel of 1.7E-04 per μg/m³. The de minimis air concentration corresponding to a 1 in 100,000 extra lung cancer risk level is 0.059 μg/m³. The TCEQ will use this conservative value to protect the general public in Texas against the potential carcinogenic effects from chronic exposure to nickel.

Quantitative human health risk assessment for 1,3-butadiene based upon ovarian effects in rodents.

A case study was prepared for noncancer risk assessment of 1,3-butadiene (BD) based upon the ovarian atrophy effects in rodents with specific consideration of the guidelines described by NAS (2009). Ovarian toxicity has been identified in the past as a sensitive endpoint for BD, and serves as the basis for noncancer risk assessment by regulatory agencies. A meta-analysis was conducted in which the available dose-response data from rats and mice were normalized using an internal dose estimate (DEB in blood) that is causally related to ovarian toxicity. A time-to-response (multistage-Weibull) model was used to simultaneously fit the pooled rodent data sets with exposure durations ranging from 13 to 105weeks. Human variation in ovarian follicle count was assumed to reflect variation in sensitivity to the adverse effects associated with follicle depletion (i.e., premature menopause). Information on follicle count in women was used in two ways: (1) the window of susceptibility (from birth to menopause) was defined as 49.6years for women born with an average follicle count, 38.7years for women born with a low follicle count, and 60.0years for women born with a high follicle count; and (2) follicle count was assumed to reflect human susceptibility due to toxicodynamic factors. The multistage-Weibull model was used to predict dose-response curves for three scenarios (average, low, and high follicle counts at birth to generate reference concentration values ranging from 0.2 to 20ppm). This case study illustrates how information on mode of action can be used to guide key decisions in the dose-response assessment with respect to identifying a dose measure, low-dose extrapolation method, background exposure, and sensitive subpopulations.

Health- and vegetative-based effect screening values for ethylene

Ethylene (ET) is ubiquitous in the environment and is produced both naturally and due to anthropogenic sources. Interestingly, the majority of ambient ET contribution is from natural sources and anthropogenic sources contribute only a minor portion. While microbes and plants naturally produce a large amount of ET, mammals are reported to produce only a small amount of ET endogenously. Anthropogenic sources of ET include the combustion of gas, fuel, coal and biomass. ET is also widely used as an intermediate to make other chemicals and products and is also used for controlled ripening of fruits and vegetables. Although, a review of human and laboratory animal studies indicate ET to be relatively non-toxic, there is concern about the potential toxicity of ET because ET is metabolically converted to ethylene oxide (EtO). EtO has been classified to be carcinogenic to human by the inhalation route by the International Agency for Research on Cancer (IARC) cancer. ET, however, has been classified as a Group 3 chemical which indicates it is not classified as a human carcinogen by IARC. Several studies have reported ET to cause adverse effects to plant species (vegetation effects) at concentrations that are not adverse to humans. Therefore, the Texas Commission of Environmental Quality (TCEQ) conducted detailed health and welfare (odor and vegetation) based assessments of ET to develop both health and vegetative based toxicity factors in 2008 in accordance with TCEQ guidelines. The health assessment based on well-conducted animal toxicity studies resulted in identification of higher points of departures and subsequently higher effect screening levels (ESLs) that were more than a magnitude higher than the threshold adverse effect level for vegetative effects for ET. Further, based on a weight-of-evidence evaluation of potential mutagenic and carcinogenic mode-of-actions for ET it appears the metabolic conversion of ET to EtO is of insufficient magnitude to cause concern of potential cancer risk. Therefore, the short-term ESL for air permit reviews and air monitoring evaluations is the vegetation-based ESL of 1200 ppb as it is more than a magnitude lower than the health-based acute ESL of 150,000 ppb. Similar to the acute derivation, the chronic evaluation resulted in the derivation of a chronic vegetation based ESL of 30 ppb that was much lower than the chronic ESL of 1600 ppb. In summary, the TCEQs acute and chronic ESLs for vegetation will protect the general public from short-term and long-term adverse health and welfare effects. The general public includes children, the elderly, pregnant women, and people with pre-existing health conditions.