Derivation of an oral toxicity reference value for nickel.

Nickel (Ni) is in the earth's crust and can be found in environmental compartments such as water, soil, and air, as well as food. This paper presents an assessment of the oral nickel toxicity data in support of non-cancer health-based oral exposure limits or toxicity reference values (TRVs). This paper derives TRVs for three populations of interest: adults, toddlers, and people who have been dermally sensitized to nickel. The adult/lifetime TRV of 20 µg Ni/kg-day is based on post-implantation loss/perinatal mortality in a 2-generation reproductive study in rats. Several recent assessments by regulatory agencies have used the same study and endpoint, but the dose-response modeling conducted here was more appropriate for the study design. Toxicokinetic data from rats and humans indicate that the applied uncertainty factors are very conservative. Because the endpoint relates to fetal exposure and is not relevant to toddlers, a toddler TRV was derived based on decreased body weight in young rats; this TRV was also 20 µg Ni/kg-day. A separate TRV of 4 µg Ni/kg in addition to Ni in food was derived for protection of nickel-sensitized populations from flare-up of dermatitis, based on studies of single exposures in humans under conditions that maximize oral absorption.

Revisiting the Avian Eco-SSL for Lead: Recommendations for Revision.

The avian ecological soil screening level (Eco-SSL) for Pb (11 mg/kg) is within soil background concentrations for >90% of the United States. Consequently, its utility as a soil screening level is limited. Site-specific ecological risk-based remedial goals for Pb are frequently many times greater. Toxicity reference values (TRVs) play a major role in defining Eco-SSLs. The Pb Eco-SSL TRV is driven by reduced egg production in Japanese quail (Coturnix japonica), which displays effects at doses both substantially lower and greater than other tested species. High variability in egg production in Japanese quail has also been observed for other contaminants. Japanese quail egg production may therefore be too variable and unreliable an effect endpoint upon which to base regulatory screening criteria. Toxicity data supporting the Eco-SSL were reevaluated and only studies reporting both no and lowest observed adverse effect levels (NOAELs and LOAELs) for reproduction, growth, or survival were considered. Dose-response data were extracted from 10 studies both as concentrations and doses. Dose-response relationships were developed using the US Environmental Protection Agency (USEPA) Benchmark Dose Software for dietary concentrations and doses for egg production in Japanese quail and chickens. Effect levels (of 10%, 20%, and 50%) were extracted from the dose-response analyses. Species sensitivity distributions and dose-response data indicated reproduction was most sensitive to Pb and survival was least sensitive, with growth intermediate. Limited data for ringed turtle doves (Streptopelia risoria) and American kestrels (Falco sparverius) suggest lower sensitivity than chickens to Pb. The ED10 and ED20 thresholds for chickens were 4.4 and 9.8 mg·kg-1 ·d-1 , respectively. Avian Pb Eco-SSLs were recalculated based on the chicken ED10 and ED20, with and without a bioavailability adjustment. Revised avian Pb Eco-SSLs for the most highly exposed species (American woodcock), based on the ED10 and assuming 100% and 50% bioavailability, were 36.3 mg/kg and 43.7 mg/kg, respectively. Integr Environ Assess Manag 2019;15:739-749. © 2019 SETAC.

Benchmark dose analysis framework for developing wildlife toxicity reference values.

The effects characterization phase of ecological risk assessments (ERAs) often includes the selection or development of toxicity reference values (TRVs) for chemicals under investigation. In wildlife risk assessments, TRVs are thresholds represented by a dose or concentration associated with a specified adverse response. Traditionally, a TRV may be derived from an estimate of the no-observed-adverse effect level or lowest-observed-adverse-effect level, identified from a controlled toxicity study. Because of the limitations of this approach, risk assessors are increasingly developing TRVs using alternative methods. Benchmark dose (BMD) analysis is widely recognized as one approach for developing TRVs. A BMD is derived using the full dose-response relationship from all experimental doses and may represent a user-specified response level (e.g., 5, 10, 20, or 50%). Although many regulatory programs consider the use of BMD-derived wildlife TRVs, there is limited guidance available for implementing the BMD approach, particularly for ERA. The present study provides a framework for ecological risk assessors to identify appropriate data, examine dose-response relationships, estimate BMDs, and document the results for use in risk analysis. This framework demonstrates the process of developing a TRV using BMD analysis and identifies applications for which this approach may enhance ERAs (e.g., site assessment, chemical or pesticide registration programs). Environ Toxicol Chem 2018;37:1496-1508. © 2018 SETAC.

An evaluation of inorganic toxicity reference values for use in assessing hazards to American robins (Turdus migratorius).

When performing screening-level and baseline risk assessments, assessors usually compare estimated exposures of wildlife receptor species with toxicity reference values (TRVs). We modeled the exposure of American robins (Turdus migratorius) to 10 elements (As, Cd, Cr, Cu, Hg, Mn, Pb, Se, Zn, and V) in spring and early summer, a time when earthworms are the preferred prey. We calculated soil benchmarks associated with possible toxic effects to these robins from 6 sets of published TRVs. Several of the resulting soil screening-level benchmarks were inconsistent with each other and less than soil background concentrations. Accordingly, we examined the derivations of the TRVs as a possible source of error. In the case of V, a particularly toxic chemical compound (ammonium vanadate) containing V, not normally present in soil, had been used to estimate a TRV. In the cases of Zn and Cu, use of uncertainty values of 10 in estimating TRVs led to implausibly low soil screening values. In the case of Pb, a TRV was calculated from studies demonstrating reductions in egg production in Japanese quail (Coturnix coturnix japonica) exposed to Pb concentrations well below than those causing toxic effects in other species of birds. The results on quail, which were replicated in additional trials, are probably not applicable to other, unrelated species, although we acknowledge that only a small fraction of all species of birds has been tested. These examples underscore the importance of understanding the derivation and relevance of TRVs before selecting them for use in screening or in ecological risk assessment. Integr Environ Assess Manag 2017;13:352-359. © 2016 SETAC.

Toxicokinetics and coagulopathy threshold of the rodenticide diphacinone in eastern screech-owls (Megascops asio).

In the United States, new regulations on second-generation anticoagulant rodenticides will likely be offset by expanded use of first-generation anticoagulant rodenticides. In the present study, eastern screech-owls (Megascops asio) were fed 10 µg diphacinone/g wet weight food for 7 d, and recovery was monitored over a 21-d postexposure period. By day 3 of exposure, diphacinone (DPN) was detected in liver (1.63 µg/g wet wt) and kidney (5.83 µg/g) and coagulopathy was apparent. By day 7, prothrombin time (PT) and Russell's viper venom time (RVVT) were prolonged, and some individuals were anemic. Upon termination of exposure, coagulopathy and anemia were resolved within 4 d, and residues decreased to <0.3 µg/g by day 7. Liver and kidney DPN elimination occurred in 2 phases (initial rapid loss, followed by slower loss rate), with overall half-lives of 11.7 d and 2.1 d, respectively. Prolonged PT and RVVT occurred in 10% of the exposed owls with liver DPN concentrations of 0.122 µg/g and 0.282 µg/g and in 90% of the owls with liver concentrations of 0.638 µg/g and 0.361 µg/g. These liver residue levels associated with coagulopathy fall in the range of values reported in raptor mortality incidents involving DPN. These tissue-based toxicity reference values for coagulopathy in adult screech-owls have application for interpreting nontarget mortality and assessing the hazard of DPN in rodent-control operations. Diphacinone exposure evokes toxicity in raptors within a matter of days; but once exposure is terminated, recovery of hemostasis occurs rapidly.

Furthering the derivation of predictive wildlife toxicity reference values for use in soil cleanup decisions.

The development of media-specific ecological values for risk assessment includes the derivation of acceptable levels of exposure for terrestrial wildlife (e.g., birds, mammals, reptiles, and amphibians). Although the derivation and subsequent application of these values can be used for screening purposes, there is a need to identify toxicological effects thresholds specifically for making remedial decisions at individual contaminated sites. A workshop was held in the fall of 2012 to evaluate existing methods and recent scientific developments for refining ecological soil screening levels (Eco-SSLs) and improving the derivation of site-specific ecological soil clean-up values for metals (Eco-SCVs). This included a focused session on the development and derivation of toxicity reference values (TRVs) for terrestrial wildlife. Topics that were examined included: methods for toxicological endpoint selection, techniques for dose-response assessment, approaches for cross-species extrapolation, and tools to incorporate environmental factors (e.g., metal bioavailability and chemistry) into a reference value. The workgroup also made recommendations to risk assessors and regulators on how to incorporate site-specific wildlife life history and toxicity information into the derivation of TRVs to be used in the further development of soil cleanup levels.

Site specific risk assessment of an energy-from-waste thermal treatment facility in Durham Region, Ontario, Canada. Part A: Human health risk assessment.

The regions of Durham and York in Ontario, Canada have partnered to construct an energy-from-waste thermal treatment facility as part of a long term strategy for the management of their municipal solid waste. This paper presents the results of a comprehensive human health risk assessment for this facility. This assessment was based on extensive sampling of baseline environmental conditions (e.g., collection and analysis of air, soil, water, and biota samples) as well as detailed site specific modeling to predict facility-related emissions of 87 identified contaminants of potential concern. Emissions were estimated for both the approved initial operating design capacity of the facility (140,000 tonnes per year) and for the maximum design capacity (400,000 tonnes per year). For the 140,000 tonnes per year scenario, this assessment indicated that facility-related emissions are unlikely to cause adverse health risks to local residents, farmers, or other receptors (e.g., recreational users). For the 400,000 tonnes per year scenarios, slightly elevated risks were noted with respect to inhalation (hydrogen chloride) and infant consumption of breast milk (dioxins and furans), but only during predicted 'upset conditions' (i.e. facility start-up, shutdown, and loss of air pollution control) that represent unusual and/or transient occurrences. However, current provincial regulations require that additional environmental screening would be mandatory prior to expansion of the facility beyond the initial approved capacity (140,000 tonnes per year). Therefore, the potential risks due to upset conditions for the 400,000 tonnes per year scenario should be more closely investigated if future expansion is pursued.

Site specific risk assessment of an energy-from-waste/thermal treatment facility in Durham Region, Ontario, Canada. Part B: Ecological risk assessment.

The regions of Durham and York in Ontario, Canada have partnered to construct an energy-from-waste (EFW) thermal treatment facility as part of a long term strategy for the management of their municipal solid waste. In this paper we present the results of a comprehensive ecological risk assessment (ERA) for this planned facility, based on baseline sampling and site specific modeling to predict facility-related emissions, which was subsequently accepted by regulatory authorities. Emissions were estimated for both the approved initial operating design capacity of the facility (140,000 tonnes per year) and the maximum design capacity (400,000 tonnes per year). In general, calculated ecological hazard quotients (EHQs) and screening ratios (SRs) for receptors did not exceed the benchmark value (1.0). The only exceedances noted were generally due to existing baseline media concentrations, which did not differ from those expected for similar unimpacted sites in Ontario. This suggests that these exceedances reflect conservative assumptions applied in the risk assessment rather than actual potential risk. However, under predicted upset conditions at 400,000 tonnes per year (i.e., facility start-up, shutdown, and loss of air pollution control), a potential unacceptable risk was estimated for freshwater receptors with respect to benzo(g,h,i)perylene (SR=1.1), which could not be attributed to baseline conditions. Although this slight exceedance reflects a conservative worst-case scenario (upset conditions coinciding with worst-case meteorological conditions), further investigation of potential ecological risk should be performed if this facility is expanded to the maximum operating capacity in the future.