Page 780 - The Toxicology of Fishes
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760                                                        The Toxicology of Fishes


                        Further advances in assessment approaches were contained in the development of water-quality-based
                       effluent permitting in the early 1980s. Effluent discharges in the United States are permitted under the
                       National Pollutant Discharge Elimination System (NPDES). Through the 1970s, discharge requirements
                       were largely technology-based standards derived from the level of effluent quality that could be reason-
                       ably achieved by each industrial or municipal discharger using the treatment technologies available at
                       the time. Although substantial reductions in pollution discharges were achieved, these standards did not
                       directly assess or prevent potential risk to organisms in the receiving waters. As such, there was no
                       assurance that meeting technology-based performance standards would actually protect aquatic life.
                        To address this shortcoming, the USEPA developed a water-quality-based approach to effluent per-
                       mitting that focused on establishing permit limits that would prevent exposures in the actual receiving
                       water from exceeding thresholds for effects on aquatic life (USEPA, 1984, 1989, 1991). In its simplest
                       form, this approach used mass balance calculations to determine the maximum amount of chemical that
                       could be discharged and still maintain chemical concentrations in-stream that met applicable water quality
                       standards to protect aquatic life (frequently the AWQC) or other designated uses. Although theoretically
                       sufficient to protect aquatic life, this mass balance approach does not consider a number of real-world
                       factors such as variability in effluent composition, variability in stream flow, and the assumption that
                       some level of infrequent exceedance of the water quality standard could likely be tolerated by the aquatic
                       community without unacceptable long-term ecological damage. A more advanced analysis was developed
                       (USEPA, 1991) that expresses variation in effluent composition and dilution water flow probabilistically,
                       allowing permit limitations to be established such that water quality standards would be exceeded at less
                       than a specified frequency with a specified level of confidence (e.g., 95% confidence of exceedances
                       less than once every 3 years). This incorporation of variability and probability is very similar to the
                       probabilistic risk assessment approaches that represent the leading edge of the science today.



                       Ecological Risk Assessment: Definitions and Concepts

                       While the practical needs of environmental decision making were advancing approaches that would form
                       the foundation for risk assessment, parallel efforts were underway to formalize the concepts underlying
                       risk assessment and to establish a consistent terminology across risk assessment applications. This has
                       led to the four-component framework known today as the risk assessment paradigm.


                       Risk Assessment Paradigm
                       In 1983, the National Research Council (NRC) defined a framework for risk assessment to facilitate the
                       development of uniform technical guidelines for conducting risk assessments (NRC, 1983). Although
                       this initial framework defined the process exclusively for human health risk assessment, the NRC
                       expanded the framework in 1993 to include ecological risk assessment (NRC, 1993). Different authors
                       and sources vary in detailed definitions, but essentially all current descriptions of both human health
                       and ecological risk assessment contain the four basic components as defined by the NRC (1993): hazard
                       identification, exposure assessment, exposure–response (effects) assessment, and risk characterization.
                       Following the NRC’s recommendation that federal agencies develop guidelines to describe how their
                       risk assessments are conducted (NRC, 1993), the USEPA developed  Guidelines for Ecological Risk
                       Assessment (Figure 18.2) (USEPA, 1998). Although the USEPA’s guidelines are not regulations, and
                       risk assessors outside of the USEPA are not obliged to use them, they do follow the NRC framework
                       and provide a comprehensive presentation of the four components of the ecological risk assessment
                       process (Norton et al., 1995; USEPA, 1998).


                       Hazard Identification and Problem Formulation
                       Hazard identification (NRC, 1993) and problem formulation (USEPA, 1998) are terms used to describe
                       the process of identifying and defining the hazards to be assessed. The NRC framework defines hazard
                       identification as “the determination of whether a particular hazardous agent is associated with health or
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