Dr.

Abdalle

CHAPTER 1:
INTRODUCTION TO ENVIRONMENTAL HEALTH RISK ASSESSMENT

1.1 WHAT IS RISK ASSESSMENT?

 Risk assessment is the process of estimating the potential impact of a chemical, physical,
microbiological or psychosocial hazard on a specified human population or ecological
system under a specific set of conditions and for a certain time frame.
 The scope of environmental health risk assessment (EHRA) can cover health impacts of:
 chemical pollutants and contaminants in air, water, soil and food
 pathogenic microbiological contaminants in food and water
 radiation sources
 electromagnetic fields (EMFs)
 climate and climate change
 In all cases of the above impacts, priority is attached to evaluating the potential human
health impacts. This update of enHealth guidance on EHRA focuses primarily on hazardous
chemicals (and to a lesser extent, microbiological hazards).
 Risk assessment relating to radiation hazards, EMFs and climate change are covered
elsewhere.
 Risk assessment is intended ‘to provide complete information to risk managers, specifically
policymakers and regulators, so that the best possible decisions are made’.
1.2 WHEN TO UNDERTAKE RISK ASSESSMENT
The issues identification phase (see Chapter 2) will determine when to undertake a risk
assessment. The need to undertake a risk assessment will be influenced by situation-specific
factors. In general, risk assessments will be needed for products, processes, situations and
activities where there is a plausible (reasonable) case that there could be an increased risk of
significant health consequences for the human population from the product, process, situation or
activity.
A risk assessment can also be used to inform the selection of the safest option when making
decisions about how to achieve a particular aim.
1.3 TYPES OF RISK ASSESSMENT

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1.3.1 Individual and population risk assessments

 Risk assessments generally make risk estimates for defined groups or populations.
 The term ‘receptors’ is often used to designate people who may be exposed to an
environmental hazard, and to whom the EHRA would be directed. Identification of
‘receptor’ locations and pathways by which they might be exposed is an integral part of any
EHRA.
 Individual risk assessment is usually estimated for a hypothetical person with assumed
characteristics for various durations of exposure (e.g. per year or per lifetime) or for
different locations.
 The hypothetical individual is designed to represent the average person in the situation or
the maximally exposed person. However, such risk estimates cannot be targeted to a specific
person. The distinction between ‘there is a risk’ and ‘I am at risk’ is often difficult to explain
to both the public and by regulators, especially when discussing very.
 Population risk assessment may relate to the number of adverse health effects (e.g.
fatalities, cancers or illnesses) in a population over a specified period of time or the rate of
adverse effects for a given location or subpopulation (Covello & Merkhofer 1993).

1.3.2 Qualitative and quantitative risk assessments

 The level of risk can be described either:-

 Qualitatively (i.e. by putting risks into categories such as ‘high’, ‘medium’ or ‘low’) or
 Quantitatively (with a numerical estimate).

1.4 THE DISTINCTION BETWEEN RISK ASSESSMENT AND RISK MANAGEMENT

 Risk assessment is a process that informs the risk management process.
 Risk management is the process of identifying, analyzing, and reducing the likelihood of
harm to patients, staff, or the organization.
 Risk assessors and risk managers should be sensitive to the distinctions between risk
assessment and risk management. The enHealth framework for EHRA clearly differentiates
risk assessment and management as separate but interlinked processes, with risk
management following the risk characterization phase of a formal risk assessment.
 The important elements of a risk management framework are whether it:

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 Evaluates the external and internal contexts (situation) of the organisation tasked with
implementing new or existing risk management plans or policies
 Provides for accountability and transparency in the decision-making process
 Ensures that resources are made available to measure and report on risk and risk mitigation
procedures
 Establishes internal and external communication and reporting mechanisms
 Ensures that there are audit processes appropriate to the evaluation of the risk management
strategies
 Provides effective processes for collecting feedback and information for continuous
improvement
 Develops monitoring and review processes at the implementation stage of all risk
management plans and strategies.
 Risk assessors should generally strive to:

 Generate an acceptable, objective, realistic and scientifically balanced analysis

 Present information on the separate components of the risk assessment
 Explain the confidence in each assessment by clearly delineating (describing) strengths,
uncertainties and assumptions, along with the impacts of these factors (e.g. confidence
limits, use of conservative/non-conservative assumptions) on the overall assessment.

1.5 EVALUATING RISK ASSESSMENT METHODS

Criteria for evaluating risk assessment methods (Covello & Merkhofer 1993) include:

 The logical soundness of the method (e.g. its justification based on theoretical arguments or
scientific knowledge, and the validity of the underlying methodological assumptions)
 Completeness (e.g. whether it can address all aspects of the problem and the degree to which
it excludes issues because they are hard to accommodate)
 Precision and accuracy (e.g. reflected in the confidence level associated with the results or
the biases resulting from undue (not requred) weight being given to specific interests or
considerations and the sensitivity of results to untested or untestable assumptions)

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 Acceptability (e.g. compatibility (similarity) with existing processes; whether it is viewed as

rational and fair; the level of understanding for all parties affected by it; and the confidence
and familiarity of those who will use it)
 Practicality (e.g. the level of expertise, time and input data required)
 Effectiveness (e.g. usefulness of results; range of applicability across different risks and
problem areas; the generalizability of the conclusion to other problem areas; and
effectiveness and efficiency of linkage with other types of methods).
1.6 THE FIVE STAGES OF ENVIRONMENTAL HEALTH RISK ASSESSMENT
(EHRA)
The historical development of formalized EHRA has resulted in the process being categorized
into five distinct stages:
1. Issue identification
2. Hazard identification
3. Dose–response assessment
4. Exposure assessment for the relevant population
5. Risk characterization.

Some of the key factors and questions that must be taken into consideration at each of these
stages include the following:

1. Issue identification: the process of recognizing and defining the core problems or concerns
that need to be addressed.

• What are the true drivers for the issue being assessed? (e.g. there is no point in doing a
quantitative cancer risk assessment if the real concern is cognitive impairment of children, and
if the latter cannot be addressed by risk assessment, then another approach may be necessary).
• Are intervention strategies available to manage the outcomes of the EHRA (e.g. containment
of contaminated soil, chlorination of water, pasteurisation of food)?
• Have transport mechanisms been adequately considered (e.g. meteorological factors affecting
air pollution, vectors for communicable diseases)?
• Are there factors that could affect persistence (e.g. photolysis and volatilisation of chemicals,
desiccation of micro-organisms)?

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• Has the risk assessment been initiated as the result of a breakdown of public health measures
(e.g. flooding affecting waste control and potable water treatment)?

2. Hazard assessment: the process of determining whether exposure to an agent can cause an
increase in the incidence of a particular adverse health effect (e.g., cancer, birth defect) and
whether the adverse health effect is likely to occur in humans

• Have the severity and reversibility of health effects been considered?

• Is there any interaction between the identified hazards and other agents in the environment?
• Is the onset of health effects immediate or delayed? While health-based guidelines generally
assume long-term continuous exposure, and are usually based on chronic (preferably lifetime)
dosing in animal studies, there may be circumstances where data from an acute or short-term
toxicity test may be more appropriate to use in the risk assessment (e.g. adverse effects
associated with irritancy).

• Is there is a critical window of exposure? This is often associated with chemicals that modify
foetal development, either during gestation or in the early postnatal period when critical neural
or organ
system developmental processes are occurring. It is also likely that epigenetic and hormonal
disturbance mechanisms act mainly during critical exposure windows.
• Has the carcinogenic and/or genotoxic potential of the identified hazards been addressed?
3. Dose–response: a determination of the relationship between the magnitude of an
administered, applied, or internal dose and a specific biological response.

• Is appropriate dose–response data available, and has the data been appropriately scaled in
translation from animal to human?
• Has the potency of the agent been determined for both acute and chronic dosing?
• Does a threshold or non-threshold model best describe the data?

4. Exposure: an identification and evaluation of the human population exposed to a toxic

agent, describing its composition and size, as well as the type, magnitude, frequency, route
and duration of exposure.

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• What is the duration, timing, frequency and consistency of exposure?

• Are exposures continuous, intermittent or episodic, or do they show clear patterns?
• Are there are relevant past, current or future exposure patterns to consider?
• Have all exposure routes (ingestion, inhalation, dermal) have been considered?
• Are exposures intergenerational or cumulative, or should they be aggregated?

5. Risk characterization: the integration of information on hazard, exposure, and dose

response to provide an estimate of the likelihood that any of the identified adverse effects
will occur in exposed people.

• Has genetic variability in the exposed population (or in the source toxicological data) been
adequately accounted for?
• Are there individual host characteristics (e.g. age, gender, body weight, pre-existing poor health,
immune status, nutritional status, previous exposures or reproductive status) that need to be
considered?
• Are there population characteristics (e.g. herd immunity and social behaviours for communicable
diseases, social mobility for exposure to air and soil contaminants, recreational patterns for
exposure to contaminated recreational waters) that need to be considered?
• Has the risk estimate been expressed quantitatively or qualitatively and, if quantitative, is it a
finite risk estimate based on extrapolation of the dose–response relationship, or is it an
acceptable daily intake (ADI) or tolerable daily intake (TDI), based on application of
safety/uncertainty/ modifying factors to a no observed adverse effect level (NOAEL), lowest
observed adverse effect level (LOAEL) or benchmark dose (BMD)?
1.7 ENVIRONMENTAL HEALTH RISK ASSESSMENT AND HEALTH IMPACT
ASSESSMENT

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Although they are related processes, health impact assessment (HIA) and EHRA address
different issues.

 HIA is defined by different agencies in different ways. The consensus definition is that of the
1999 Gothenburg consensus paper by the WHO Regional Office for Europe, as described in
the enHealth Health impact assessment guidelines (enHealth 2001).
... a combination of procedures or methods by which a policy, program or project may be
judged as to the effects it may have on the health of a population.
 In other words, HIA is a systematic process to assess the actual or potential, and direct or
indirect, effects on the health of individuals, groups or communities arising from
environmental conditions or hazards arising from policies, objectives, programs, plans or
activities.
 It looks at both potential health benefits and health impacts from an activity or situation.
 It is usually a process undertaken as part of an environmental impact assessment for a
significant project and looks at both positive and negative impacts on health.
 HIA is generally undertaken in the early stages of project planning in order to predict and
facilitate avoidance of potentially negative health impacts, to promote more positive health
impacts and to promote sustainable development. It takes into consideration the social and
socioeconomic factors.
 The definition of ‘health’ is taken to be ‘a complete state of physical, mental and social
wellbeing and not merely the absence of disease or infirmity’ (WHO Constitution). This
definition has not been altered since it was promulgated in 1948.
 In this context, EHRA is simply a tool for appraising health risks (i.e. adverse health impacts)
from contaminant exposures in the broader process of health impact assessment.

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