Environmental Remediation (EnEng5222)

Chapter 3

Human Health Risk Assessment in Site

Remediation
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 Outline
 Introduction
 Human Health Risk Assessment Overview
 Use of Risk-Based Tools and Risk-Informed Decision-Making in
Site Remediation Process
 Conceptual Site Model and Application of Risk-Based Tools to
Impact Sites

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Outcomes
At the end of this unit, you will be able to:
 Define human health risk assessment
 Explain the basic steps in human health risk assessment
 Describe risk based assessment tools
 Discuss how the risk assessment and risk management tools may
be used to inform decision-making in the site remediation
process.
 Develop Conceptual Site Model for site remediation
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 Introduction
 “All substances are poisons; there is none which is not a poison; the
right dose differentiates a poison and a remedy.” Paracelsus (1493–
1541).
 Toxicity of a contaminant to a human is related to the dose that the
human takes into the body.
 Pollutant’s impact on human health depends on;
 human body’s intake of pollutants in magnitude (dose)
 the length of time exposed to this pollutant

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 Introduction
 Human health risk assessment is about assessing human exposure
and dose response to chemicals and other agents.

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 HUMAN HEALTH RISK ASSESSMENT
OVERVIEW
 Human heath risk assessment: is the process of estimating the nature
and probability of adverse health effects in humans. It typically includes
four basic steps:
1. Hazard identification: Evaluate whether a chemical has the potential to
cause harm to humans, and under what circumstances.
2. Dose-response assessment: Determine the numerical relationship
between chemical exposure and adverse (cancer and noncancer) health
effects.
3. Exposure assessment: Determine the frequency, duration, and levels of
contact with chemicals of concern.
4. Risk characterization: Quantify the health risk based on dose and
exposure, and examine how well the data support conclusions. 6
 Hazard Identification
 The process of determining whether exposure to a stressor
(environmental contaminants in this case) can cause an increase in the
incidence of specific adverse health effects (e.g., cancer, birth defects).
 Objective:
 Identify the types of adverse health effects that can be caused by exposure to the
contaminants in question.
 To characterize the quality and weight of evidence supporting this identification.
 Sources of data
 Epidemiological studies: involving a statistical evaluation of human populations
to examine the association between exposure to a contaminant and a health effect.

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 Hazard Identification
 Animal studies (rats, mice, rabbits, monkeys, etc.) that are designed to draw
inferences about the potential hazard to humans.
 Human studies are generally preferable, often limited by not having
accurate exposure data and the effects of other stressors that cannot be
controlled in the studies.
 Animal studies can be controlled to address specific data gaps, but
they are subject to uncertainties due to extrapolating results from
animals to humans.
 A key component of hazard characterization involves evaluating the
weight of evidence regarding a chemical’s potential to cause adverse
health effects.
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 Dose-Response Assessment
 Describes how the likelihood and severity of adverse health effects
(the responses) are related to the amount and condition of exposure to
a chemical (the dose).

Hypothetical linear dose-response plot

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 Dose-Response Assessment
 LD50: the dosage of a
substance that kills 50% of
the animals over a set
period of time following an
acute exposure.

 The lower the LD50, the

higher its toxicity

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Dose-Response Assessment

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 Dose-Response Assessment
 For carcinogens, linear extrapolation is typically used as the default
approach for dose-response assessment.
 the toxicity is assumed not to have a threshold, the dose below which
no deleterious effect is expected to occur.
 For non-carcinogens, their toxicities are typically assumed to
have a threshold.
 No-observed-adverse-effect level (NOAEL) is the highest exposure
level at which no statistically or biologically significant increases are
seen in the frequency or severity of adverse effect between the
exposed population and its appropriate control population

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 Dose-Response Assessment
 In cases in which a NOAEL has not been demonstrated
experimentally, the term lowest-observed-adverse-effect level
(LOAEL) is used, which is the lowest dose tested.
 fails to take into consideration the shape of the dose-response curve and other
related information.
 Reference dose (RfD): is defined as an oral or dermal dose derived
from the NOAEL, with uncertainty factors (UFs) applied to reflect the
limitations of the data used.
RfD = NOAEL (or LOAEL or BMDL) / UFs

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 Dose-Response Assessment
 UFs take into account the variability and uncertainty that are reflected
in possible differences between test animals and humans (generally
10-fold) and variability within the human population (generally
another 10-fold);
 thus, the UFs are multiplied together: 10×10=100 (multiplied by another 10 if
an LOAEL is used).

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 Exposure Assessment
 The process of determining the magnitude, frequency, duration, and
route of human exposure to chemicals in the environment.
 Exposure often estimated through measured concentrations in the
environment, models of chemical fate and transport within and across
the environmental media, and estimates of human intake over time.
 The general procedure for exposure assessment includes three basic
steps.
Step 1 – characterizing exposure setting: characterization of the physical
environment and potentially exposed populations at and near the site based
on the current and future land uses.

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 Exposure Assessment
Step 2 – identifying exposure pathways: consists of four components: a
chemical source/release, fate and transport of contaminant(s), a point of
human exposure, and an exposure route (ingestion, dermal contact, and
inhalation).
 It is useful to prepare a conceptual site exposure model (CSEM) to list
these components and potentially exposed populations identified in
the first step for all exposure pathways relevant to the site.

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17
 Exposure Assessment
Step 3 – quantifying exposure: estimation of exposure concentrations
and calculation of intakes for each exposure pathway.
 The exposure concentration term is typically estimated in two ways:
 Central tendency (the arithmetic mean or 95% upper confidence limit on the
mean).
 Reasonable maximum exposure (RME): The highest exposure that is
reasonably expected to occur at a site. Usng the maximum or an upper
percentile (e.g., 90th–98th) value within an exposure unit.
 Besides the exposure concentration, the intake also depends on the
contact rate, contact time, body weight, and averaging time.
 Ingestion Exposure: expressed as an average daily intake (milligrams
of chemical per kilogram of body weight per day).
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 Exposure Assessment

Intake (I ) = (C× CR×EF ×ED) / (BW × AT ); Were

I (mg/[kg×day]) is the average daily chemical intake

C (mg/kg or mg/liter water) is the chemical concentration in soil or water
CR (kg/day or liters/day) is the contact (i.e., ingestion) rate for soil or drinking
water
EF (days/year) is the exposure frequency
ED (years) is the exposure duration
BW (kg) I is the body weight
AT (days) is the average time
For cancer, AT is 70 years×365 days/year
For noncancer, AT is ED (years)×365 days/year 19
 Exposure Assessment
 Inhalation Exposure: Current USEPA guidance recommends use of
the chemical concentration in air (e.g., micrograms per cubic meter)
based on inhalation rate and body weight.
Exposure concentration (EC ) = (CA×ET×EF× ED ) / (AT)
where:
EC (µg/m3) is the exposure concentration
CA (µg/m3) is the contaminant concentration in air
ET (hours/day) is the exposure time
AT (hours) is the average time
For cancer, AT is 70 years×365 days/year×24 hours/day
For noncancer, AT is ED (years)×365 days/year×24 hours/day

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 Risk Characterization
 Integrate toxicity and exposure assessments into quantitative or
qualitative (if some information is missing) expressions of cancer
risk and noncancer hazard.
 The equations to quantify risks are also different for different
exposure pathways.
 For ingestion and dermal contact, the cancer risk and noncancer
hazard can be calculated with
Risk = I (life) × SF
HQ = I (life) / RfD

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 Risk Characterization

where:
Risk is the cancer risk (unitless; probability of an individual developing cancer
over lifetime)
HQ is the noncancer hazard quotient (unitless)
I(life) is the average lifetime intake (mg/kg-day; see Equation 3.2)
SF is the slope factor ([mg/kg-day]−1); the plausible upper-bound estimate of the
probability of a response (cancer) per unit intake of chemical over a lifetime
RfD is the reference dose (mg/kg-day)

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 Risk Characterization
 For the inhalation route, the cancer risk and noncancer hazard can be
calculated with
Risk = EC× IUR
HQ = EC × RfC
where:
EC is the exposure concentration (µg/m3)
IUR is the inhalation unit risk ([µg/m3]−1)
RfC is the reference concentration (µg/m3)
 It is very important to assess the uncertainty associated with each step of the
process on the results of risk assessment.
 Toxicity factors and exposure parameters recommended by regulatory agencies are
generally conservative and thus, likely to over-estimate actual health risks.
 summation of the risks for individual chemicals ignores possible synergistic or
antagonistic effects among these chemicals 23
 Risk Management Decision
 Risk management determines how to manage risks in a way best suited to
protect human health and the environment.
 Besides the scientific results from the risk assessment process, risk
management should also consider other factors, including;
 Laws and policies that define the basis for regulatory decisions to manage
environmental problems.
 Technological factors such as the feasibility, implementability, and short-
term and long-term effectiveness of risk management options.
 Economic factors such as the costs and benefits of reducing risks by various
mitigation or remediation alternatives.

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 Risk Management Decision
 Social factors such as income level, ethnic background, availability of
health care, public values and perceptions on environmental issues.
 Political factors such as acceptance by other agencies (e.g., state and
local governments), legislative sectors, special interest groups, and
concerned citizens.

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Risk Management Decision

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 Use of risk-based tools and risk-informed
decision-making in site remediation process
Risk-Informed Decision Making (RIDM)
 is a set of practical, technically defensible, and consistent activities (i.e., site
investigation, exposure/risk assessment) and solutions (e.g., risk
management options such as engineering controls and/or land use and
access controls) that help to manage a site cleanup cost-effectively.
 It advocates the combination of “best management practices” with “best
available technology” to protect public health, water quality, and the
environment.
 RIDM has four elements; site assessment, risk assessment, risk
management, and environmental policy and regulation.

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 Use of risk-based tools and risk-informed
decision-making in site remediation process
 Site assessment includes innovative, cost-effective techniques to
collect a variety of background information on the actual or perceived
problem (i.e., is there a public health/ water quality/environmental
problem?).
 governed by the pathways and receptors
 provides a framework for the entire project and an excellent communication
tool for the regulators, potential responsible parties (PRPs), and other
stakeholders.
 Risk assessment is a way of integrating and analyzing the variety of
information to quantify the problem.
 i.e., what are the nature and the magnitude of health and environmental
impacts caused by contaminants?
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 Use of risk-based tools and risk-informed
decision-making in site remediation process
 Risk management consists of practical ways of responding to the
problem, which may include engineering and/or institutional solutions
(i.e., how do we manage the problems?).
 Environmental policy and regulation would use current science and
relevant information, address knowledge gaps and uncertainty,
balance technologic/economic limitations and societal issues, and
establish appropriate standards.

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 Use of risk-based tools and risk-informed
decision-making in site remediation process

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Roles of Risk Assessment and Risk Management
in Site Remediation Process
 Incorporate site-specific risk assessment and risk management into all
phases of the cleanup process on the discovery of contamination at
any site.
 Four key questions where risk-based tools can inform decision-
making in this process;
 Does the site have enough data?
 Does the site need remedial action?
 How to choose a remedy?
 What is the remediation goal?

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 Conceptual site model (CSM) and application of
risk-based tools to impact sites
 A CSM is a summary of current understanding about the site
conditions and pollution characteristics.
Contaminant Fate and Transport Processes
 Advection: is a process whereby dissolved contaminants are
transported physically with moving groundwater
 The transport speed depends on the groundwater velocity

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33
 Contaminant Fate and Transport Processes
 Dispersion and Diffusion
 Dispersion is a process whereby dissolved contaminants disperse due to
mechanical disturbance or agitation by an uneven velocity of
groundwater.
 Diffusion is a process whereby dissolved contaminants diffuse due to
molecular movement along a concentration gradient in groundwater.
 The processes of dispersion and diffusion are expressed under one

coefficient, called the dispersion coefficient.

 In real groundwater transport cases, both advection and dispersion

happen concurrently.

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 Contaminant Fate and Transport Processes
 Sorption is a process whereby contaminants become attached
physically or chemically to solid soil particles in the vadose zone or
groundwater.
 The equation governing sorption is commonly expressed as follows:
C S = Kd ⋅ Cl = Koc ⋅ foc ⋅ C l
where:
Cs is chemical concentration in sorbed phase
Cl is chemical concentration in liquid phase
Kd (Koc ·foc) is contaminant partition coefficient between solid phase and
liquid phase (L/kg)
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 Contaminant Fate and Transport Processes
Koc is chemical octanol-carbon partition coefficient (L/kg)
foc is solid organic carbon content (unitless)
 Most material sorption studies are focused on the quantification of soil
organic carbon content, since Koc is readily available from the literature.

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 Contaminant Fate and Transport Processes
 Volatilization is a process whereby contaminants volatilize physically
from the dissolved phase or the solid phase in the vadose zone or
groundwater.
 The governing equation is commonly expressed as follows:
H = Cgas / Cl (20°C )
where:
H is the Henry’s Law constant
Cgas is chemical concentration in gaseous phase
Cl is chemical concentration in liquid phase

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Contaminant Fate and Transport Processes
 Bio-Transformation is a process whereby contaminants change their
chemical formation by biological processes in the environment.
 This process is very important in bio-degradation and bio-remediation
 The following equation is commonly used to estimate the concentration
decrease rate (exponentially).
Ct = C0 exp (−λ t)
where:
Ct is contaminant concentration at time t
C0 is initial contaminant concentration at time 0
λ is the decay constant (1/year)
t is the time (years) 39
 Contaminant Fate and Transport Processes
 The concept of degradation “half-life” is defined as the time needed to
reduce the initial concentration to the level of 50% of the initial
concentration. It then can be calculated as;
Ct = 0.5 ⋅ C0
Based on the previous equation;
0.5 = exp (−λ t)
Ln 0.5 = −λ t
t1/2 = 0.693/ λ
where t1/2 is the contaminant degradation half-life (years)
 The t1/2 value can be readily calculated if the decay constant λ is available in the
literature and can then be used to estimate the cleanup time for a remedial system40
   Selection of a Cost-Effective Remedy at a
PCB-Contaminated Site: Case study
 Active industrial manufacturing facility in a Midwest state in the United
States (Song et al., 2006).
 The soils at a portion of the facility were impacted by historical use of
PCBs as hydraulic fluids.
 The surrounding areas are currently zoned industrial, and the future land
use is expected to remain the same. Remedial alternatives;
 Alternative 1: Soil cover (capping with 3 ft clean soil) only
 Alternative 2: Soil cover+removal of >1500 ppm PCB-impacted soils
 Alternative 3: Soil cover+removal of >500 ppm PCB-impacted soils
 Alternative 4: Soil cover+removal of >50 ppm PCB-impacted soils

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Alternative 2 was selected as the final remedy for implementation at the
site. 42