Society of Environmental Toxicology and Chemistry Technical Issue Paper Environmental Risk Assessment of Chemicals Environmental Risk exposure to a chemical for organisms, such as animals, plants, or microbes, in the environment, which could be Assessment of Chemicals water, soil, or air. Effects can be assessed at different levels of biological organization, which is to say in Environmental risk assessment determines the single cells, individuals, populations, ecosystems, or nature and likelihood of harmful effects occurring landscapes. to organisms such as humans, animals, plants, or microbes, due to their exposure to stressors. A stressor can be a chemical (such as road salt runoff to a lake), Applications of Environmental exotic species (such as a foreign plant), or a change Risk Assessment of Chemicals in physical conditions (such as dredging a channel). Here, we focus on risk assessment of chemicals. The Environmental risk assessments of chemicals can be chemicals can be something that is found in nature, used at many scales. They can take place at the small- such as copper, or something created by humans, such scale site level (such as a release at a manufacturing as pharmaceuticals. Depending on whether humans plant), at the field-scale level (for example, spraying or other organisms or ecosystems are exposed, a plant protection products or pesticides on crops), risk assessment is called either a “human health” or at a regional level (such as a river catchment or an “ecological” risk assessment. Here, the term or bay). Policy makers, including government “environmental risk assessment” is used to include both. agencies, and industries use risk assessments to support environmental management decisions. Risk Human health risk assessment of chemicals is used assessments can help the public make informed to evaluate the health effects chemicals may have on decisions, for example, whether to eat certain foods or individuals and populations. For example, it predicts to decide which household products are safest to use. the probability of an increase in cancer incidence in a population from exposure to a chemical known or A retrospective environmental risk assessment is used suspected to cause cancer. It is also used to evaluate to predict adverse effects from exposure after it has the likelihood and severity of other non-cancer adverse occurred (for example, after chemicals have been effects after exposure to chemicals. released into the air). Ecological risk assessment of chemicals evaluates A prospective environmental risk assessment is the likelihood and magnitude of adverse effects from used to predict adverse effects based on estimated SETAC Technical Issue Paper exposure (for example, this would be used to regulate Hazard is the potential of a stressor to cause harm whereas chemicals such as cleaning products before they are risk is a function of the likelihood of exposure occurring and the harm caused by that exposure if it occurs. permitted for use or for release into the environment through a discharge permit, such as for air emissions or wastewater release). By definition, environmental risk assessment of chemicals is the process of predicting the chance of adverse effects. Additionally, the same process can be used, essentially in reverse, to predict Exposure Hazard exposure levels associated with limited harm based on toxicity thresholds and expected exposure. Risk assessment is a valuable tool that can be used to: » Estimate amounts of chemicals in environmental resources, such as water, soil, and air, for various uses, such as drinking, swimming, fishing, and Risk agricultural production; » Guide environmental management decisions, such as how to best develop an old factory site into a park or residential apartment building. Specific examples of risk assessments include: Chemical environment fate properties, important » Determining how much pesticide can be applied to chemical hazard and exposure potential, include in an orchard while limiting harm to bees, birds, or issues such as how long it takes for the chemical to other pollinators; break down in the environment (its persistence) and » Recommending or rejecting a new industrial whether it is broken down or builds up when consumed chemical by calculating its leaching behavior (its potential for accumulating in the organisms or to in order to determine if it will contaminate bioaccumulate) or how likely it is to dissolve in water groundwater; (its solubility), which can affect toxicity and exposure. A chemical’s environment fate properties are described » Evaluating if a chemical found in an environment by various measures, such as rates of solubility in fat could cause adverse effects to an organism in the and water, volatility, degradation, and bioaccumulation. same environment; Chemical toxicity is best described as the relationship » Evaluating the benefits of remediation and between the amount (dose) of a chemical needed restoration options at polluted areas. to cause harm (described by a dose–response relationship). Hazard assessment and exposure assessment can provide important insights and can Environmental Risk have independent utility, but both must be considered Assessment of Chemicals – together when estimating risk. General Approach For example, scientists use laboratory tests to determine how much of a chemical a fish can be A chemical’s capacity to cause adverse effects depends exposed to before the chemical causes harmful effects, on both chemical exposure and hazard potential. such as a decline in the number of its offspring, as a Chemical exposure refers to how much and how often measure of the chemical’s toxicity to fish. On the other the receptor, such as a plant, an animal, or a human, hand, the actual amount of a chemical in the water comes into contact with the chemical. Chemical where a fish lives, is a measure of that fish’s exposure. hazard potential is the inherent (intrinsic) capacity of a Risk refers to the probability of harm occurring and the chemical to cause harm. A chemical’s hazard potential amount of harm. It could be described as the “probable could be based on its environmental fate properties as proportional reduction of the number of offspring” in well as its toxicity. this example. 2 SETAC Technical Issue Paper This diagram displays how the different components of an Environmental Risk environmental risk assessment relate to one another. Assessment – Components Environmental risk assessments are generally made Problem Formulation up of a few components, sometimes referred to by different terms. Problem Formulation Hazard Exposure Identifies the scope and objectives of a risk assessment. Assessment Assessment Lays out the plan and technical approach for conducting the risk assessment. Answers the questions of Who? What? Where? Why? What for? and How? Risk Exposure Assessment Characterization Evaluates the potential exposure scenarios, and the intensity of exposure (how much and how frequently). When evaluating chemicals, exposure pathways (such Uncertainty as drinking) and routes of exposure (such as oral, Assessment dermal, or inhalation) are determined. Hazard Assessment Conclusions Examines if and how a stressor could cause adverse effects and under what circumstances, and it identifies the type and strength of those effects. Environmental Risk Risk Characterization Combines exposure and hazard information. Results Assessment - The Process can be presented as a binary yes-or-no response or a The environmental risk assessment process is designed probability. They can also be presented as one value to be a “tiered” process. The lowest tier, Tier I, requires (deterministic) or a range of values (probabilistic). the least amount of data and can quickly give Uncertainty Assessment conservative answers that are health protective. A Tier I risk assessment is often referred to as a screening- Describes sources of uncertainty (such as extrapolating level risk assessment and is based on very simple from a laboratory rat to a human and lack of data used and, therefore, conservative assumptions that may in making exposure assumptions). overestimate risk. Therefore, a Tier 1 risk assessment by Conclusions design will have the highest safety factor. Integrates the results of the risk characterization and Often, in a Tier I risk assessment of chemicals, levels uncertainty assessment, often based on the various of concentrations of chemicals are compared to outcomes in a systematic weight-of-evidence approach. “screening levels.” Screening levels are concentrations 1 “Weight-of-Evidence in Chemical Risk Assessment” that are not expected to be associated with harmful refers to the process of assembling, weighing, and effects. Measured concentrations less than screening evaluating evidence, in a risk assessment, to come to a levels indicate that adverse effects are not expected, scientifically defensible conclusion. An example would while concentrations greater than screening level be using chemical concentrations in sediment, water, indicate the need for more analysis since screening and plants at a contaminated pond to assess risk to a levels are inherently designed to be over-protective. duck through its diet as one line of evidence and using If adverse effects cannot be excluded in a Tier I measured survival of ducklings at the pond as another risk assessment, more data are acquired and more line of evidence. sophisticated models are used to refine the risk estimate as the risk assessment progresses through the subsequent