Introduction of Human Health Risk Assessment

Budiyono
• Risk analysis is a process that incorporates three components: risk
assessment, risk management and risk communication.
• What is Risk?
• Risk is a function of Toxicity and Exposure
• If either Toxicity or Exposure=0,  Risk =0
• Exposure  ↑,  Risk  ↑
• Exceptions  -­‐  modifying factors
• Human health risk assessment
• is a process intended to estimate the risk to a given target organism,
system or (sub)population, including the identification of attendant
uncertainties, following exposure to a particular agent, taking into
account the inherent characteristics of the agent of concern as well as
the characteristics of the specific target system (IPCS, 2004).
• Human health risk assessment of chemicals refers to methods and
techniques that apply to the evaluation of hazards, exposure and harm
posed by chemicals, which in some cases may differ from approaches
used to assess risks associated with biological and physical agents.
• The risk assessment process begins with problem formulation and
includes four additional steps:
1) hazard identification,
2) hazard characterization,
3) exposure assessment and
4) risk characterization (IPCS, 2004).
 Hazard identification
• Chemical and physical properties
• Toxicity
• Eco-toxicity
• Persistent in environment
• Bioaccumulation
• Environmental mobility and fate
 Hazard characterization
Dose-response, Adverse effect, Reversible-irreversible, Threshold dose,
No-adverse effect level
• In vivo
• In vitro
• Field study
 Exposure assessment
Quantification of exposure on target/target system (human population,
environmental species/ecosystem)
• Environmental concentration
• Environmental distribution, pathway and fate
• Receiving environment, compartement, target population
 Risk characterization
Probability that the chemical would cause adverse effect
• Exposure (intensity, frequency and duration)
• Route of exposure
• Toxicity/ecotoxicity
 Scope of risk assessment
Step Description Content
Problem formulation Establishes the scope and Defining the question
objective of the assessment Prior knowledge
Desired outcomes
Hazard identification Identifies the type and Human studies
nature of adverse health Animal-based toxicology studies
effects In vitro toxicology studies Structure–
activity studies
Hazard characterization Qualitative or quantitative Selection of critical data set
description of inherent Modes/mechanisms of action
properties of an agent Kinetic variability
having the potential to Dynamic variability
cause adverse health effects Dose–response for critical effect
Exposure assessment Evaluation of concentration Magnitude
or amount of a particular Frequency
agent that reaches a target Duration
population Route
Extent
Risk characterization Advice for decision-making Probability of occurrence
Severity
Given population
Attendant uncertainties
 risk depends on the following factors
1. the amount of a chemical present in an environmental medium (e.g.
soil, water, air), food and/or a product;
2. the amount of contact (exposure) a person has with the pollutant in
the medium
3. the toxicity of the chemical.
environmental health paradigm and its relationship to the human health risk assessment framework
Mechanistic basis for the
Environmental
sequence of events in the Risk assessment framework
health paradigm
environmental health
paradigm

Emission
source(s) Exposure
assessment
Pollutant transport,
transformation and What environmental
fate processes exposures are
expected to occur,
Environmental and what is the Risk
concentrations resulting dose to
Biological, target tissue? characterization
chemical, physical Demographic,
and social geographic, lifestyle What is the
determinants of and ecological estimated risk
the critical events attributes Hazard from
leading from anticipated
release of toxic Exposure characterization exposure?
agents into the What is the
environment to relationship
resulting disease between dose to
or injury in people Pharmacokinetics1 the target tissue
or the environment and adverse
effects?
Internal dose
Hazard
identification
Pharmacodynamics2
Is the
environmental
Adverse
agent capable of
effect(s)
1
Toxicokinetics - what the body does to the agent causing an
2
Toxicodynamics - what the agent does to the body adverse effect?
Thank You
 Tiers of risk assessment
Tier Description Hazard identification Hazard Exposure assessment Risk
characterization/ characterization
guidance or guideline
value identification
1: Screening Existing hazard and Identify the chemical; Apply appropriate Existing qualitative or Qualitative or
exposure data from obtain hazard information existing guidance or quantitative quantitative
international sources from international guideline values from estimates; local
resources international exposure conditions
organizations
2: Adaptive existing hazard data Identify the chemical; Adjust guidance or Existing quantitative Qualitative or
from international obtain hazard information guideline values from estimates; local quantitative
sources reflecting from international international exposure conditions
local conditions; resources organizations for local
existing local conditions
exposure data
3: Modeling or field- Existing hazard data Identify the chemical; Adjust guidance or Conduct Qualitative or
based from international obtain hazard information guideline values from measurement or quantitative
sources; new local from international resource international modelling campaign
exposure data organizations for local
conditions
4: De novo Locally conducted Independent review of Establish new Estimate from Qualitative or
hazard and exposure original hazard data or guidance or guideline measurements or quantitative
assessments controlled experimental value models
trials, gather local
observations
• Tier 1 (screening level) refers to screening-level risk assessments that
rely solely upon existing guidance and guideline values and other
information and make no adjustments to the hazard characterization
for local conditions or other considerations.
• Consider an example where there is strong anecdotal information that
use of a certain chemical is associated with a significant or specific
health outcome among workers of a certain industry.
• hazard identification information on toxicological properties of the
chemical and experiences in other countries are consistent with the
anecdotal reports.
• a public health official may conclude that occupational health risks of
using the chemical under current conditions are intolerable.
• In a move intended to protect health, the official may seek to ban the
chemical from that particular use or from the country at large based on
generalizing risk information from international sources to the local
uses and conditions
• pesticide
• Tier 2 (adaptive level) refers to risk assessments that reflect local
exposure conditions, which can be incorporated through the exposure
assessment or hazard characterization stages
• local exposure conditions are derived from existing information. Such
information may be the result of routine monitoring conducted for
regulatory or other purposes, the application of a model to a known or
suspected source of pollutant emissions or some other metric that was
generated for a purpose other than the current assessment.
• The particulate matter
• Tier 3 (modelling or field-based level) risk assessments involve quantitative characterization
of exposure conditions through a measurement or modelling campaign, but otherwise are
similar to a Tier 2 assessment.
• Tier 3 assessments require the design and execution of a quantitative exposure assessment.
• the exposure assessment will consist of a survey; in others, the assessment may be
hypothesis driven. A field campaign would require a plan for collection and analysis of
samples as well as management and interpretation of the data.
• Similarly, a modelling campaign would require selection of an appropriate modelling tool,
identification of values needed to parameterize the model, resources to execute the model
and data management and analysis skills to manage and interpret the model results.
• The drinking-water case-study
• Tier 4 (de novo) risk assessments are unique in that they can involve
the review of original data or the generation of new information
concerning the hazardous properties of a chemical.
• Tier 4 risk assessments involve measurement or modelling
approaches for the quantitative assessment of exposure that is
specific to local conditions.
• Tier 4 assessments apply to chemicals or chemical forms whose
toxicological properties have not been evaluated previously, as well as
to new routes of exposure to existing chemicals.
Thank You