Phases of ERA - Planning and Problem Formulation

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Planning

Risk managers and risk assessors bring valuable perspectives to the initial planning activities for an ERA. Risk managers charged with protecting the environment can identify information they need to develop their decision. Risk assessors can ensure that science is effectively used to address ecological concerns. Together they can evaluate whether a risk assessment can address identified problems (U.S. EPA, 1998).

Planning and Problem Formulation
As described the Guidelines for Ecological Risk Assessment (U.S. EPA, 1998), planning is the initial phase of an ecological risk assessment (ERA). During planning, risk managers and risk assessors define the goals, scope, and timing of a risk assessment. These may include government officials, politicians, ecologists, toxicologists, wildlife biologists, chemists, statisticians, engineers. They also identify the resources that are available and necessary to achieve the goals. 

After the planning phase, problem formulation process begins.

Problem Formulation

Planning and problem formulation is often an iterative process (U.S. EPA, 1998). It is a step that may be revisited throughout the course of the exposure assessment as new information is collected and preliminary results are obtained.

Problem formulation is a process for generating and evaluating preliminary hypotheses about why ecological effects have occurred, or may occur, from human activities (U.S. EPA, 1998). During problem formulation,

  • the purpose for the assessment is articulated,
  • the problem is defined, and
  • a plan for analyzing and characterizing risk is determined.

As described in U.S. EPA’s Guidelines for Ecological Risk Assessment (U.S. EPA, 1998) problem formulation may include the integration of available information on sources, stressors, effects, and ecosystem and receptor characteristics. The table below summarizes information that may be considered during problem formulation.

Assessing the Available Information: Sources, Stressors, Exposures, and Receptors
Factor Considerations Example Questions
Stressors Types Chemical, physical, or biological? (Note that multiple contaminants and sources often impact a single site.)
Characteristics What effects are expected to be elicited by the stressor(s)?
Modes of Action How do the stressors act on organisms or ecosystem functions?
Toxicity AcuteAdverse effects that result from a single dose or single exposure of a chemical; any poisonous effect produced within a short period of time, usually less than 96 hours., chronicCauses an adverse effect in which symptoms recur frequently or develop slowly over a long period of time., bioaccumulativeBioaccumulation is the general term describing a process by which chemicals are taken up by a plant or animal either directly from exposure to a contaminated medium (soil, sediment, water) or by eating food containing the chemical. Related terms are bioconcentration which chemicals are absorbed by an animal or plant to levels higher than the surrounding environment; and biomagnification, in which chemical levels in plants or animals increase from transfer through the food web (e.g., predators have greater concentrations of a particular chemical than their prey)., or nonpersistentRefers to chemicals that break down quickly in the environment.?
Frequency of events Isolated, episodic, or continuous; is it subject to natural daily, seasonal, or annual periodicity? For biological stressors, is there an opportunity for repeated introduction or escape into the new environment?
Duration How long does it persist in the environment (e.g., for chemical, what is its half-lifeThe length of time required for the mass, concentration, or activity of a chemical or physical agent to be reduced by one-half., does it bioaccumulateBioaccumulation is the general term describing a process by which chemicals are taken up by a plant or animal either directly from exposure to a contaminated medium (soil, sediment, water) or by eating food containing the chemical. Related terms are bioconcentration which chemicals are absorbed by an animal or plant to levels higher than the surrounding environment; and biomagnification, in which chemical levels in plants or animals increase from transfer through the food web (e.g., predators have greater concentrations of a particular chemical than their prey).; for physical, is habitat alteration sufficient to prevent recovery; for biological, will it reproduce and proliferate)?
Distribution How do the stressors move through the environment (e.g., for chemical, fate and transport; for physical, movement of physical structures; for biological, life-history dispersal characteristics)?
Intensity What is the dose or concentration of a chemical, the magnitude or extent of physical disruption, the density or population size of a biological stressor)?
Sources Status Is the source still active?
Background levels What are background or baseline conditions? 
Spatial scale What is the extent and delineation of the source? Is the extent or influence of the stressors local, regional, global, habitat-specific, or ecosystem-wide?
Exposure Media What environmental media (i.e., air, soil, water) first receive stressors? What are the potential exposure pathways to other media?
Timing When does exposure occur in relation to critical organism life cycles or ecosystem events (e.g., reproduction, lake overturnLake overturn is the complete, wind-induced, top-to-bottom circulation of water in deep lakes. Also referred to as lake turnover.)?
Receptors Types, characteristics, life history What habitats are present? Which species are considered essential to, or indicative of, the healthy functioning of the habitat (e.g., stream invertebrates)? What types of water bodies are present? What species of plants and animals can be found at the site? What are the mobility patterns of the animals? Are any of the animal species migratory? Do any have large home ranges? Sensitive life stages?
Routes What are the exposure routes of the stressors (i.e., dermal, ingestion, or inhalation)?
Susceptibility,
SensitivityMore susceptible to the adverse effects of exposure to toxic chemicals, pesticides, and other pollutants.

Are there rare, endangeredAnimals, plants, birds, fish, or other living organisms threatened with extinction by man-made or natural changes in the environment., or threatenedA plant or animal that is likely to become endangered if not protected. species on or near the affected area? Are there any species protected under Federal or State law (e.g., Migratory Bird Treaty Act, Marine Mammal Protection Act)? Are there any keystone speciesA species whose survival affects other organisms in an ecosystem. If a keystone species were removed from an ecosystem, the ecosystem would drastically change., sensitive speciesSpecies more susceptible to the adverse effects of exposure to toxic chemicals, pesticides, and other pollutants., or other species of concern?

Trophic levelsEach step along a food chain; an organism's feeding level.? Predators can become more highly exposed through biomagnificationBioaccumulation is the general term describing a process by which chemicals are taken up by a plant or animal either directly from exposure to a contaminated medium (soil, sediment, water) or by eating food containing the chemical. Related terms are bioconcentration which chemicals are absorbed by an animal or plant to levels higher than the surrounding environment; and biomagnification, in which chemical levels in plants or animals increase from transfer through the food web (e.g., predators have greater concentrations of a particular chemical than their prey). in the food chainA food chain is formed as one organism eats another. A food web is a system of interlocking and interdependent food chains, in which each organism supplies energy to another life form. or from feeding more often (or exclusively) on a specific type of prey that accumulates contaminants more easily than other prey types.

Sources: OSWER, 1997; U.S. EPA Region 5, 2011; U.S. EPA, 1991; 1998.

Using this information risk assessors can develop: assessment endpoints and a conceptual model. These two products are needed to complete an analysis plan.

  • According to U.S. EPA’s Guidelines for Ecological Risk Assessment (U.S. EPA 1998) an assessment endpoint is “an explicit expression of the environmental value that is to be protected, operationally defined by an ecological entity and its attributes.” Assessment endpoints include two elements: identification of the specific receptor that is to be protected (e.g., species, community, ecosystem), and a characteristic about the receptor of concern that is important to protect (e.g., survival, growth, reproduction).
  • The Guidelines for Ecological Risk Assessment (U.S. EPA 1998) define a conceptual model as “a written description and visual representation of predicted relationships between ecological entities and the stressors to which they may be exposed.” The conceptual model consists of two components: a set of risk hypotheses that describe the predicted relationships among stressor, exposure, and assessment endpoint and a diagram that illustrates these relationships.
  • The analysis plan summarizes what has been done during problem formulation and targets those hypotheses that are likely to contribute to the risk. It also evaluates the risk hypotheses to determine how they will be assessed and develops the assessment design. It identifies data gaps and uncertainties and determines which measures will be used to evaluate the risk hypotheses. It also ensures that the planned analyses will meet the risk managers' needs.

Phase 1 of the ERA: Planning and Problem Formulation

Goal

Articulate the purpose for the assessment, define the problem, and make a plan for analyzing and characterizing risk.

Who is involved?

  • Risk assessors and other professionals who bring expertise relevant to the locations, stressors, ecosystems, scientific issues, and other expertise as needed, depending on the type of assessment.
  • Risk managers—individuals and organizations who have the responsibility or authority to take action or require action to mitigate an identified risk.
  • Other interested parties, or “stakeholders” that may include Federal, State, tribal, and municipal governments, industrial leaders, environmental groups, small-business owners, landowners, and other segments of society concerned about an environmental issue at hand or attempting to influence risk management decisions.

Approach

  • Planning
    • Identify the interested parties: risk assessors, risk managers, stakeholders.
    • Begin the planning dialogue between risk assessors and risk managers.
    • Determine if a risk assessment is the best option for supporting the decision.
    • Come to agreement on the goals, scope, and timing of a risk assessment and the resources that are available and necessary to achieve the goals.
  • Problem Formulation
    • Refine objectives for the risk assessment.
    • Evaluate the nature of the problem: gather available information on stressor sources and characteristics, exposure opportunities, characteristics of the ecosystem(s) potentially at risk, and ecological effects.
    • Select assessment endpointsAn explicit expression of the environmental value to be protected, operationally defined as an ecological entity and its attributes. that identify specific receptors to be protected and characteristics about the receptors that are important to protect.
    • Develop conceptual modelsA written description and visual representation of predicted relationships between ecological entities and the stressors to which they may be exposed. that describe predicted relationships among stressors, exposures, and assessment endpoints.
    • Develop an analysis plan that includes a delineation of the assessment design, data needs and uncertainties. The plan also includes measures that will be used to evaluate the risk hypotheses, and methods that will be used for conducting the analysis.
    • Describe pathways and relationships identified during problem formulation that will be pursued during the analysis phase of the ERA. Ensure that the planned analyses will meet risk manager needs.

Products

  • Planning
    • Clearly established and articulated management goals.
    • Characterization of decisions to be made within the context of the management goals.
    • Description of scope, complexity, and focus of the risk assessment, including the expected output and the technical and financial support available to complete the assessment.
  • Problem Formulation
    • Site description that defines the scale and site boundaries, describes the habitat, and identifies species that are present. Site description may be based on actual site, conceptual site, or generic site.
    • Assessment endpointsAn explicit expression of the environmental value to be protected, operationally defined as an ecological entity and its attributes. that adequately reflect management goals and the ecosystem they represent.
    • Conceptual modelsA written description and visual representation of predicted relationships between ecological entities and the stressors to which they may be exposed. that describe key relationships between a stressor and assessment endpoint or between several stressors and assessment endpoints.
    • Analysis plan
      Source: U.S. EPA 1998

The planning and problem formulation phase within the overall ecological risk assessment process is illustrated below (adapted from U.S. EPA, 1998). Analysis is directed by the products of problem formulation.

Problem Formulation

References

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Last updated on May 26, 2024