Environmental Health Risk

Assessment

PHC6311

Alok Deoraj, Ph.D.

HLSII590, extension: 7-7793
Email: [email protected]
1
 Week 5

•Exposure Assessment and Models

•Aggregate and cumulative risk

•Risk at workplace (read the chapter-9

Page 187-201, 213 last paragraph-219
and 226-234)
•
•
 Learning Objectives

• Demonstrate the concept of exposure from various pathways

(aggregate exposure)
• Describe different exposure models, e.g., air, water, land
• Identify rationale for probabilistic assessments and statistics needed to
understand the process
• Describe the uncertainty and variability in exposure assessment
• Explore methods for assessing risks from multiple chemicals (and
cumulative)
• Understand the scope, magnitude, distribution and temporal changes in
the major safety and health hazards workers face on the job
• Become familiar with institutions (OSHA and NIOSH) to control
workplace hazards
• Appreciate the complex interplay of science and policy involved in
controlling occupational risks
•
Uses of Exposure Assessment in
Risk Assessment

Hazard Identification
Dose-response assessment
Exposure Assessment
Risk Characterization
Risk Communication

• Used to estimate internal dose which, with dose response data

(usually in animals), is used to estimate risk.
• For risk-based regulations, provides the link to emissions (point
source, consumer products, area sources).
• Evaluation of efficacy of cleanup (risk to most exposed
subgroup).
 Important Attributes of Exposure

• What is Exposure? Dose?

• General Equations for Estimating Exposure
• Types/Sources of Information on Contact
Rates
• Measuring vs Modeling Exposure Pt
Concentrations
• Probabilistic Exposure Assessment
Why assess exposure?

• Determine factors that put segments of the

population at higher risk to chemical toxicity
• Help establish dose-response relationships in
the “real world”
• Hazard = Toxicity x Exposure
Use Exposure Assessment for Status and Trends

• Determine exposure at a particular place and

time as well as trends over time.
• Provide a profile of a population or a
population segment.
• Establish effectiveness of risk mitigation
strategy (regulations).
The Importance of an Accurate
Exposure Assessment

• Estimated risks are based on the results.

• Over-estimation of risks can lead to
unnecessarily costly cleanup.
• Under-estimation can result in health risk on
human population and ecosystem.
What is Exposure?
Considerations for Exposure Assessment

1.Different Kinds of Doses.

2.
3.Range of Exposure.
•Central Tendency
•High End
•
3. Quantifying Exposure
•Point of Contact
Measurement
•Scenario Evaluation
•Reconstruction
Exposure Scenarios

• Actual Exposures
• Reasonably Foreseeable Exposures
• Hypothetical Exposures
• What-If Exposures
• Counter-Factual Exposures
•
Typical Exposure Scenarios
• Case I: Airborne dust/vapor
• Case II: Soil
• Case III: Groundwater
• Case IV: Sediment
• Case V: Foods
Illustration of Exposure Pathways

From:
Paustenbach, DJ. (2000)
The practice of exposure
assessment: a state-of-
the-art review. J Toxicol
Env Health, 3:179-291
 Models for Estimating
Concentration
– Atmospheric Models
– Surface-Water Models
– Groundwater Models
– Food-Chain Models
– Multimedia Models
• Distinguishing Features from a Risk Assessors
Perspective
– Input Data Requirements
– Extent of Model Validation
• All models are simplified or idealized representations
of physical and/or biological processes that may be
too complicated or too poorly understood to
express in any other way.
Morning CO Exposure Profile of
an EPA Employee
Personal Exposure to Benzene
 Three elements of exposure
assessment

• Transportation, transformation and fate

processes
– Before it meets up with people
• Exposures
– As it meets up with people
• Physiologically based pharmacokinetics
(PBPK)
– What goes on In people
 Exposure Elements
Transport, Transformation,
and Fate Process Models
SOURCE/STRESSOR EFFECT
FORMATION
Chemical Acute
Exposure Chronic
Microbial
Models
TRANSPORT/ DOSE
TRANSFORMATION
Dispersion Target
Kinetics PBPK Absorbed
Thermodynamics Models Applied
Spatial variability ENVIRONMENTAL
Distribution CHARACTERIZATION
Meteorology
Air
Water
Diet
Soil and dust EXPOSURE
Groundwater
Pathway • Individual
Duration • Community
ACTIVITY Frequency • Population
PATTTERN Magnitude
Statistical profile
Reference population
Susceptible individual
Susceptible subpopulations
Population distributions
Blood lead levels
Issues in Dose and Response

Time (Days)
Time-Weighted Average

• TWA
• Total dose divided by time period of dosing
• This is what is used for toxicology assumption
 Exposure Assessmet_EPA

• The process of measuring or estimating the intensity, frequency,

and duration of human contact with agents currently present
in the environment or the hypothetical contact that might
arise from their release in the environment.
• The EPA Guidelines for Estimating Exposure (U.S. EPA, 1986a)
defines exposure as the contact with a chemical or physical
agent.
• --The magnitude of this contact is determined by measuring or
estimating the amount of an agent available at the exchange
boundaries during some specified time.
• --Once the agent is absorbed through these boundaries, the
amount crossing the boundary becomes the absorbed dose.
• The primary purpose of an exposure assessment is usually to
estimate the real-world dose (exposure) value to use in a
dose-response relationship.
Methods of exposure
assessment vary with needs

• A highly sophisticated exposure assessment may be

needed if the objective is to ensure that no
individual is overexposed to a dangerous
substance
• Only screening exposure assessment may be
needed as an approximate estimate of exposure
for priority setting
• Exposure should be assessed so that it can be
related to dose (and possible health effect) with
sufficient accuracy and precision to meet research,
regulatory, or exposure control objectives
Each assessment strategy
presents different issues of
relevance

• Data
• Sample type personal/area
• Chem. Specific
• Time specific
• Location specific
• Activity specific
Other fate/ Transport Factors

• Persistence
• Microorganisms
• Light
• Moisture
• pH
• Temperature
• Half-life
Other Factors in Exposure
Assessment
• Duration and frequency of exposure must be considered in an
exposure assessment. In terms of duration, exposures may
be acute (one-time), chronic (repeated, for a substantial
fraction of the lifespan (example: 10%) of a lifetime). Except
for acute exposures, there are no standardized quantitative
definitions of these terms. Frequency of exposure is also
important-exposure may be continuous (daily) or intermittent
(less than daily, with no standardized, quantitative definition).
•
• Finally, it is important to know, for exposures of limited duration,
the time in life during which exposure took place. For a
teratogenic agent, for example, it is essential to know
whether exposure took place or could take place during the
subject’s pregnancy.
Aggregate Exposure

• Sum total of exposure to a chemical via ALL

routes of exposure and in all media
• Concentration times duration
•

• E.g., DDT:
– 6 to 10 sources (fruits and veggies)
– Three routes (air, food, water)
 Lifetime Average Daily Dose (ADD)

• 70 year old person • Bioavailability

• Has eaten lettuce • 4 mg Aldrin per kg
since age 4 (14,000 lettuce
kg)
•
•
C ⋅ IR ⋅ D ⋅ B
LADD =
BW ⋅ LT
Examples of direct monitoring

• The best-known example of the direct

measurement of exposure is the radiation
dosimeter
• CO Assessment by EPA
• Individuals randomly selected; Interviewed by
telephone and screened to obtain smaller
stratified population
• Stratified by CO Exposure Risk Factors:
Smoking, commute time, other
• Personal CO Monitor used for several days
• Urban CO Exposure profile established
•
Indirect Monitoring

• Site selection influences results (e.g. spacial

and temporal variation)
• Must incorporate pattern analysis for
exposure estimates job classification
• Human activity patterns
•
•
Databases

• Plumbs from power plants to determine nature of

transport and transformation processes from a
single-point source of emission
• Non-point source air pollution evaluation
• PCBs and DDT in Western Lake Superior
• Dispersion of sewage sludge discharged from
vessels off the coast of NYC
• National Emissions Data Systems: TSP, Sox, Nox,
HCs & CO.
• Hazardous and Trace Emission System: Pollutants
not regulated by primary ambient air quality
standards
Spacial Variation

• Random Sampling: Monitor locations selected

in a random manner so that it is not
possible to predict location of any sampling
point based on the location of others
• Systematic Sampling; laying out a grid
• Initial point selected randomly
• Assures uniform sampling across areas
• More complex statistically
Spatial Variability in Pollutant Air
Concentration (ug/m3) Downwind of an
Industrial Emission Source
Temporal Variation

• Sequential measurements at one site

• Temporal correlations must be accounted for;
if ignored, mean and confidence interval
underestimated
• E.g. concentration of a contaminant in an
aquifer measured at a given well on one
day depends on the concentration on the
previous day.
Temporal Variability in Pollutant Air
Concentration (ug/m3) Downwind of an
Industrial Emission Source
Models for Exposure Assessment
• A model is a mathematical expression
representing a simplified version of
exposure processes.
• Provides a means by which diverse data on
relevant factors can be combined to predict
levels of human or environmental exposure
• Modeling is an iterative process of input and
refinement
• Large range of models of different complexity,
from back of the envelope to complex
computer simulations (EPA-Air Pollution
Models)
Types of Models

• Gaussian Plume Model- plume from an

emission source spreads laterally and
vertically, ascending to a Gaussian
distribution
• Trajectory Models-compute the trajectory that
a pollutant might follow.
• Puff Transport Models- rapid, short-duration
emissions
• Compartmental Models
Pollution Fate and Transport
Models
• Objective- determine the average
concentration of a pollutant in time for a
population by one or more exposure
pathways
• Pollutant may be a chemical or biological
agent
• Time may range from seconds to years
• Exposure pathways-standard
•
Variables in different pollutant
transport and fate models
• Environmental transport media (air, surface or ground
water, biota)
• Geographic scale (global, national, regional, local)
• Pollutant source characteristics (continuous or
instantaneous release, industrial, residential or
commercial, and point or area sources
• Risk agents (e.g., a specific compound or class of
related subjects)
• Receptor populations (normal
humans/animals/plants/MO, highly exposed,
susceptible)
• Exposure routes (typical or unusual e.g. breast milk)
• Time Frame
Atmospheric Models

• Focus on pollution transport, diffusion, and deposition

•
• Transport- movement of suspended of pollutant through the
atmosphere
• Diffusion- microspread and dilution of individual particles and
molecules
• Deposition- transfer to ground/water or vegetation (wet or dry)
• Many variables influence transport/diffusion/deposition
• Atmospheric stability (resist or enhance vertical motion of the
air)
• Temperature inversion
• Industrial emissions dispersion a function of: stack velocity,
temperature not atmospheric stability, and stack height
•
•Model Outputs

• Atmospheric concentrations
• Wet and dry deposition rates
Atmospheric Dispersion Model

• Example of a validated model

Case Air pollution

• Location of Exposed Persons

• On-site
• Off-site
• Air Concentration
• Peak concentration (1 and 24 hours)
• Annual average concentration
Air Contaminants (When?)

• Exposure Duration
• Constant exposure
• Routine (but non-continuous)
• Sporadic
Air Contaminants (How much?)

• Determine
• Concentration at point of exposure
• Breathing rate per body weight
• Absorbed dose (uptake)
Air Contaminants (How much?)

• Estimating Concentration
• Direct measurements
• Indirect measurements
• Published emission rates
• Mathematical models for emissions
• Dispersion models
Air Contaminants from Soil
(How Much?)
• Mathematical Models
• Farmer’s Model
• Jury’s Behavior Assessment Model (BAM)
• Fugitive dust model
• Particulate emission models
Air Contaminants from soil

• Factors Affecting Vapor Flux

• Physical properties of chemical
• Vapor pressure
• Solubility
• Saturation Vapor Density
• Adsorption Tendencies
• Molecular Weight
Other Factors

• Properties of Soil Matrix

• Bulk Density
• Porosity
• Moisture Content
• Organic Carbon Fraction
Other Factors (Vapor from Soil)

• Environmental Factors
• Humidity
• Temperature
• Barometric Pressure
• Precipitation
• Wind Speed
Air Contaminants (How much?)

• Dose= Concentration (mg/m^3) * Ventilation

(m^3/hr) * bioavailability (%)
Contaminated Soil

• Residential (children/adults)
• Industrial (adults)
• Parks/Recreation (children/adults)
• Sediments due to Runoff (fishermen/fish)
• Wildlife (grazing animals)
Contaminated Soil (How?)

• Residential (children eat soil or dust)

• Industrial (dermal contact)
• Agricultural (food)
• Parks/recreation (ingestion/dermal contact)
• Wildlife (soil ingestion/forage)
•
Dermal Exposure Parameters

• Concentration in soil, dust, or water

• Soil/dust deposition rate from the air
• Direct soil contact
• Skin permeability rate
• Area of exposed skin
• Body weight
State-of-the-Art Issues

• Consider using site/sub-population exposure

parameters
• Soil ingestion
• Water ingestion
• Bioavailability
• Greater use of Monte Carlo analysis
• Better presentation of uncertainty
Empirical Data

• Direct measurement
• Usually measures applied dose
• A variety of methods and equipment have
been developed
Biological Monitoring

• Body burden levels or biomarkers

• Concentration of chemical in tissues or sera
– Usually not the tissue of concern
– Need to understand internal dose relationship
• Concentration of the chemical’s metabolites
• Biological response chemicals
• Chemical or metabolites bound to target
molecules
Modeling Exposure

• “Exposure Scenarios”
• Recreating past doses
• Predicting future doses
• Two major components
– Chemical concentrations (including time
trends)
– Population characterizations
 Important goals for the Improvement
of Exposure Information

• Collect data over time (Establish a “baseline”, and follow

trends)
• Establish standard methods and protocols (Use standard
methods and protocols, and apply consistent
requirements for quality control/quality assurance)
• Develop statistically representative sampling data (Allow
extrapolation beyond the individual study)
• Collect more measurements of exposure
• (For developing, validating, and refining human exposure
models)
• Support epidemiologic studies
Important goals for the Improvement
of Exposure Information

• Collect data over appropriate time frames

(Support epidemiologic studies, allow
evaluation or prediction of acute and
subchronic, as well as chronic effects
• Characterize total human exposures (Allow
evaluation of total exposures to individual,
multiple polluntants)
• Allow source apportionment or identification
of key sources of exposure
 Important goals for the Improvement
of Exposure Information

• Characterize exposures to pollutant mixtures (For

individual routes of exposure)
• Identify high-risk groups (Identify biologically susceptible
subpopulations and subgroups receiving exposures at
upper tail of exposure distribution, or “high-end”
exposures
• Address environmental inequities
• Identify regional, ethnic, or socioeconomic
subpopulations likely to receive “high-end” exposures
• Develop distributions of exposure (Allow characterization
of variability and uncertainty in exposure parameters,
estimates, and measurements
 Exposure Factors Handbook

• Drinking water • Body surface areas

consumption rates • Body weights
• Breast milk consumption • Shower times, intensities,
rates temperatures
• Consumption rates of • Animal exposures
foods – Domestic
• Soil ingestion rates – Wildlife
• Breathing rates
Standard Assumptions

– 70 yr life span
– 70 kg Body weight
– 2 L/day water consumption
– 200 mg/day

Variability?
Geographic
Cultural
Variability versus central tendencies
Dermal exposure

• Cutaneous permeability
• Dermal bioavailability
• Skin surface area
• Soil loading on the skin
Skin uptake of a chemical in soil

• Uptake = C × A × r × B
• C in mg material per kg soil
• A in cm2
• r in mg / cm2
• B is unitless (bioavailability)
Deterministic Model

• Point Values for Each Variable

• Some Typical or Average Values
• Some High End or Upperbound Values
 History of the Monte Carlo Method

Monte Carlo simulation was named after the city in Monaco (famous for
its casino) where games of chance (e.g., roulette) involve repetitive
events with known probabilities. Although there were a number of
isolated and undeveloped applications of Monte Carlo simulation
principles at earlier dates, modern application of Monte Carlo methods
date from the 1940s during work on the atomic bomb. Mathematician
Stanislaw Ulam is credited with recognizing how computers could
make Monte Carlo simulation of complex systems feasible
The probability of getting a given value for the total on the dice may
be calculated by taking the total number of ways that value can be
produced and dividing it by the total number of distinguishable
outcomes. So the probability of a 7 on the dice is 1/6 because it
can be produced in 6 ways out of a total of 36 possible outcomes.

http://hyperphysics.phy-astr.gsu.edu/hbase/math/dice.html
Skin uptake of a chemical in soil

• Uptake = C × A × r × B
• C in mg material per kg soil
• A in cm2
• r in mg / cm2
• B is unitless (bioavailability)
Monte Carlo Analysis

• Uptake = C × A × r × B
• What if we know distributions of C, A, and r,
and uncertainty surrounding B!
• MEI (maximally exposed individual)
• 95% worst case for each?
• 1 - (1-0.95)4 = 99.9994 case?
Monte Carlo Analysis

• A taste:
• C = lognormal (12 mg / kg, 3 mg / kg)
• A = 500 cm2
• r = uniform (0.015 kg / cm2,0.025 kg / cm2)
• B = lognormal (0.75, 0.02)
• Mean Uptake = 70 mg
• Upper 95%? = 180 mg / kg
Monte Carlo Analysis

• 95% upper CI?

• C = lognormal (12 mg / kg, 3)
• A = 500 cm2
• r = uniform (0.015 kg / cm2,0.025 kg / cm2)
• B = lognormal (0.75, 0.02)
• Uptake = 70 mg
 Monte Carlo Uptake?

Forecast: Uptake
10,000 Trials Frequency Chart 9,828 Displayed
.025 252

.019 189

.013 126

.006 63

.000 0
26.86 59.54 92.22 124.90 157.58
Certainty is 95.00% from 49.19 to 151.37 mg
 • Risk at workplace
•

• (Read chapter-9: Page 187-201, 213 last

• paragraph-219 and 226-234)
•