RISK

A common definition of risk is that it is the combination of a specific hazard and the
likelihood that the hazard occurs (probability)x(hazard) = risk. That likelihood may
be expressed as a rate or a probability. For example the risk of an aircraft accident
(hazard) can be expressed as one accident per million flights (likelihood).
Risk can be objectively defined so that two people can take the same data and come
up with a similar result. Risk can be expressed in many ways, so long as it combines
a hazard with likelihood. The concept of risk exists in aviation, finance, human
health, and many other areas. One can use the methods of science, engineering, and
math in order to define risks.
RISK ASSESSMENT:
Risk assessment is the process of analyzing potential losses from a given hazard
using a combination of known information about the situation, knowledge about the
underlying process, and judgment about the information that is not known or well
understood.
Risk is defined as the product of a hazard (such as damage costs) and the
probability that this hazard occurs. In other words, (probability)x(hazard) = risk.
The first two values must be known or at least estimated in order to define risk.

Risk assessment characterize the nature and magnitude of health risks to humans
(e.g., residents, workers, recreational visitors) and ecological receptors (e.g., birds,
fish, wildlife) from chemical contaminants and other stressors that may be present
in the environment. Risk managers use this information to help them decide how to
protect humans and the environment from stressors or contaminants. Note that
risk managers can be:

federal or state officials whose job it is to protect the environment,

Business leaders who work at companies that can impact the environment.

Private Citizens who are making decisions regarding risk.

Environmental risk assessments typically fall into one of two areas: Human
Health and ecological.

Risk assessment is, to the highest extent possible, a scientific process. In general
terms, risk depends on the following factors:

How much of a chemical is present in an environmental medium (e.g., soil,

water, air),
How much contact (exposure) a person or ecological receptor has with the
contaminated environmental medium?
The inherent toxicity of the chemical.

Following a planning and scoping stage where the purpose and scope of a risk
assessment is decided, the risk assessment process usually begins by collecting
measurements that characterize the nature and extent of chemical contamination in
the environment, as well as information needed to predict how the contaminants
behave in the future.
Based on this, the risk assessor evaluates the frequency and magnitude of human
and ecological exposures that may occur as a consequence of contact with the
contaminated medium, both now and in the future.
This evaluation of exposure is then combined with information on the inherent
toxicity of the chemical (that is, the expected response to a given level of exposure) to
predict the probability, nature, and magnitude of the adverse health effects that
may occur. In the ideal world, all risk assessments would be based on a very strong
knowledge base (i.e., reliable and complete data on the nature and extent of
contamination, fate and transport processes, the magnitude and frequency of
human and ecological exposure, and the inherent toxicity of all of the chemicals).
However, in real life, information is usually limited on one or more of these key data
needed for risk assessment calculations. This means that risk assessors often have to
make estimates and use judgment when performing risk calculations, and
consequently all risk estimates are uncertain to some degree. For this reason, a key
part of all good risk assessments is a fair and open presentation of the uncertainties
in the calculations and a characterization of how reliable (or how unreliable) the
resulting risk estimates really are.
Developing a risk assessment is often an iterative process, which involves
researchers identifying and filling data gaps in order to develop a more refined
assessment of the risk. This in turn may influence the need for risk assessors and
risk managers to refine the scope of the risk assessment further triggering the need
for more data or new assumptions.

ECOLOGICAL RISK ASSESSMENT

An ecological risk assessment is the process for evaluating how likely it is that the
environment may be impacted as a result of exposure to one or more environmental
stressors such as chemicals, land change, disease, invasive species and climate
change.
Every day, people face questions about environmental concerns, many of them
related to plants, animals, ecosystems as a whole, and how we interact with them.
These questions may be about potential risks such as impacts on the aesthetic value
of a place due to physical alterations, effects of pollution on endangered species, or
the consequences of long-term release of contaminants to an ecosystem. For
example:

How would the construction of a dam impact fish populations in nearby

water bodies?
Can the residential or agricultural application of an insecticide end up
harming an endangered bird species?
Do contaminants in the environment from an abandoned industrial or
mining facility significantly reduce the use of the site and to nearby areas?
What is the risk of introducing a non-native oyster to an estuary?
How does fertilizer runoff reduce oxygen levels in water bodies such as bays?
Are some plants or animals more likely to be susceptible to environmental
stressors because of factors such as age, genetics, body size, or differences
among species?

Potential effects of stressors such as those described above and managing risks from
them in order to protect the health of the natural environment, and the natural
resources that people rely on.

STEPS OF ECOLOGICAL ASSESSMENT

1. Planning
There is a need to make judgments early when planning risk assessments regarding
the purpose, scope, and technical approaches that will be used. To simplify our
discussion of planning the following structure focuses on ecological risk assessment.
This website also presents more detailed information on human health and
ecological risk assessment.
Risk assessors will typically ask the following questions when planning a human
health risk assessment:

Who/What/Where is at risk?

Individual

General population

Life stages such as juveniles or adults

Population subgroups highly susceptible (for example, due to

genetics) and/or highly exposed (for example, based on geographic area)

Different species mink, for example, are highly susceptible to PCBs

What are the environmental hazards of concern?

Chemicals (single or multiple/cumulative risk)

Physical (changes to a habitat)

Microbiological or biological (disease or invasive species)

Nutritional (for example, fitness or metabolic state)

Where do these environmental hazards come from?

Point sources (for example, smoke or water discharge from a factory;

contamination from a Superfund site)

Non-point sources (for example, automobile exhaust; agricultural

runoff)

Natural sources

How does exposure occur?

Pathways (recognizing that one or more may be involved)

o
o
o
o
o
o

Air
Surface Water
Groundwater
Soil
Solid Waste
Food

Routes (and related human activities that lead to exposure

o
o
o
o

Ingestion (both food and water)

Contact with skin
Inhalation
Non-dietary ingestion (for example, preening/grooming behavior)

What does the body do with the environmental hazard and how is this impacted
by factors such as life-stage, genetics, species differences, etc.?

Absorption does the body take up the environmental hazard

Distribution does the environmental hazard travel throughout the

body or does it stay in one place?

Metabolism does the body break down the environmental hazard?

Excretion how does the body get rid of it?

What are the ecological effects?

Example of some ecological effects include, but are not limited to, changes in
reproductive rates, tumors, effects on the nervous system, and mortality.

How long does it take for an environmental hazard to cause a toxic effect? Does
it matter when in a lifetime exposure occurs?

How long?
o
o
o
o

Acute - right away or within a few hours to a day

Subchronic - weeks or months (for humans generally less than
10% of their lifespan)
Chronic - a significant part of a lifetime or a lifetime (for humans
at least seven years)
Intermittent

Timing
o

Is there a critical time during a lifetime when a chemical is most

toxic (e.g., fetal or embryonic development, juvenile stages,
adulthood)?

2. Phase 1
A key component of the Problem Formulation stage is defining an assessment
endpoint to determine what ecological entity is important to protect.
An ecological entity can be:

A species (for instance: piping plover)

A functional group of species (for instance: piscivores - i.e., fish eaters)

A community (for instance: benthic invertebrates)

An ecosystem (for instance: lake)

A specific valued habitat (for instance: wet meadows)

Another entity of concern

Once the entity has been identified, the next step is to determine what specific
attribute(s) of the entity is potentially at risk and important to protect. This
provides a basis for measurement in the risk assessment.

Determining ecological relevance in specific cases requires professional judgment

based on site-specific information, preliminary surveys, or other available
information.
Ecological relevance is linked to:

Nature and intensity of effects

Spatial and temporal scales of effects

Potential for recovery

Level of organization potentially affected

The entity's role in the ecosystem

More than one level of organization may need to be considered.

It is rarely clear which of these ecosystem components are most critical to ecosystem
function. Further, professionals and the public don't always agree on which are
most valuable. This increases the challenge in choosing which ecological
characteristics to protect. Three principal criteria clarify this choice:

Ecological relevance

Susceptibility to known or potential stressors

Relevance to management goals

The challenge is to find ecological values that are scientifically rigorous and are also
recognized as valuable by risk managers and the public. Possible successful
examples include:

Endangered species or ecosystems

Commercially or recreationally important species

Ecosystem functions or services such as food supply, flood control, or

nutrient cycling

Aesthetic values such as clean air in national parks

Existence of charismatic species such as eagles or whales

Once assessment endpoints are chosen, a conceptual model is developed to provide a

visual representation (a map, flow chart, or schematic) of hypothesized relationships
between ecological entities and the stressors to which they may be exposed,
accompanied by a written description of this process and of the risk questions.
These models include information about:

Source

Stressors

Receptors

Potential exposure

Predicted effects on an ecological entity (the assessment endpoint)

3. Phase 2
The goal of the analysis phase is to provide the ingredients necessary for
determining or predicting ecological responses to stressors under exposure
conditions of interest.

Analysis is the determination of what plants and animals are exposed and to what
degree they are exposed and if that level of exposure is likely or not to cause harmful
ecological effects. Calculations used may include:

hazard quotients (e.g., the ratio of chemical contaminant concentration to

a selected screening benchmark) to quantify risk; and

various parameters to determine the levels of exposure to a stressor (e.g.,

chemical contaminant) by a selected plant or animal (receptor), such as:
o

Area use: the proportion of the site that is in the area an animal
typically uses during normal activities (home range); OR the
proportion of an animals home range that is within a site;

Food ingestion rate: how much food is consumed by an animal over a

specific period of time (typically, one day);

Bioaccumulation rates: the 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;

Bioavailability: how easily a plant or animal can take up a particular

contaminant from the environment;

Life stage: juvenile, adult, etc.

4. Phase 3
Risk Characterization is the final phase of an ecological risk assessment. It is the
culmination of all work done during the previous phases.

During risk characterization, the assessor uses the results of analysis to estimate the
risk posed to ecological entities. The assessor then describes the risk, indicating the
overall degree of confidence in the risk estimates, summarizing uncertainties, citing
evidence supporting the risk estimates, and interpreting the adversity of ecological
effects.
When estimating ecological risk, factors considered include:

Is the risk acute or chronic?

What is the severity of effects?
What is the time over which they occur?
Is the risk to one species or many species?
How many organisms are at risk?

Some approaches used to answer these questions and develop the risk estimate
include:

Field observational studies (surveys)

Categorical rankings
Process models that rely partially
approximations of exposure and effects
Comparisons of exposure and effects data

or

entirely

on

theoretical

Principles of Conducting Risk Characterizations

A good risk characterization will restate the scope of the assessment, express results
clearly, articulate major assumptions and uncertainties, identify reasonable
alternative interpretations, and separate scientific conclusions from policy
judgments. EPA's risk characterization policy calls for conducting risk
characterizations in a manner that is consistent with the following principles:

Transparency - The characterization should fully and explicitly disclose the

risk assessment methods, default assumptions, logic, rationale, extrapolations,
uncertainties, and overall strength of each step in the assessment.

Clarity - The products from the risk assessment should be readily understood
by readers inside and outside of the risk assessment process. Documents should
be concise, free of jargon, and should use understandable tables, graphs, and
equations as needed.

Consistent - The risk assessment should be conducted and presented in a

manner which is consistent with EPA policy, and consistent with other risk
characterizations of similar scope prepared across programs within the EPA.

Reasonable - The risk assessment should be based on sound judgment, with

methods and assumptions consistent with the current state-of-the-science and
conveyed in a manner that is complete, balanced, and informative.

In order to achieve transparency, clarity, consistency, and reasonableness( or

TCCR) in a risk characterization, these same principles need to have been applied
in all of the previous steps in the ecological risk assessment which lead up to the risk
characterization.