Risk Assessment in Environmental Decision Making

Keeve Nachman, PhD, MHS

Johns Hopkins University
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What Is Risk Assessment?

n  Risk assessment is a policy tool designed to facilitate management of environmental

health hazards
u  Also used in other disciplines

n  Risk assessment is an integration of information from various scientific domains

u  Toxicology, epidemiology, environmental exposure/engineering, behavioral science

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What Is (or Isn’t) Risk Assessment?

n  Risk assessment in itself is not science!

n  Instead, it draws from multiple

scientific disciplines to facilitate
decision making

n  Risk assessment is a policy tool that ...

u  May require subjective judgments
from risk analysts
u  Usually requires discretion on the
part of the risk manager

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Who Uses Risk Assessment?

n  Federal and international agencies

u  EPA, OSHA, FDA, CDC/ATSDR, CPSC,
USDA, DOD/USACE, DOE, NASA,
DOT, USFWS
u  WHO/IPCS

n  State environmental/health agencies

u  CalEPA, NYDHMH

n  Industry

n  Non-governmental groups

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How Is Risk Assessment Used?

n  Environmental (chemical) hazards

u  Setting regulations
•  National Ambient Air Quality Standards: 24-hour, 8-hour, 1-hour standards
•  Safe Drinking Water Act: MCL, MCLG (maximum contaminant level, maximum
contaminant level goal)
•  Food Quality Protection Act: pesticide tolerances in foods
u  Estimation of contaminated site risks and cleanup goals
•  Superfund, Brownfields redevelopment

n  Other hazards

u  Physical (radiation, noise), microbial, injury

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The Four Steps of Risk Assessment

National Research
Council (1983) (Risk Paradigm)

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Hazard Identification

n  Identify chemicals of concern and potential associated health effects

n  Evaluate evidence that exposure to a given chemical elicits an adverse response
u  Toxicology, epidemiology, in vitro studies

n  Qualitative evaluation of relationship between exposure and adverse effects

u  Weight of evidence discussion

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Some Key Assumptions Used in Hazard Identification

n  Effects seen in one human population are predictive for others

n  Average human may be as sensitive as most sensitive animal

responder

n  Site concordance (tumors) or effects concordance (non-cancer

responses) do not necessarily hold

Image Source: Rama via Wikimedia Commons. Creative Commons BY-SA.

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Dose-Response Assessment

n  Quantitative characterization of the relationship

between a chemical agent dose and the incidence of
adverse health effects
n  Supporting data
u  Epidemiologic studies (gold standard)
u  Toxicological studies (most common)
u  In vitro studies

n  Considerations
u  Type of endpoint (carcinogenic vs. non-cancer)
u  Type of exposure (route, duration)
u  Relevance of effect in test species to humans
u  Relevance of study doses to actual human
exposures

Image Source: Rama via Wikimedia Commons. Creative Commons BY-SA. 12

Dose-Response Reference Values

n  Where possible, quantitative toxicity metrics are presented

u  Non-cancer
•  Specified for duration: chronic, subchronic, acute
Ø  Oral reference doses (RfD)
Ø  Inhalation reference concentrations (RfC)
u  Cancer
•  A weight of evidence description (e.g., known human carcinogen)
•  Cancer potency factor (AKA slope factor, q*)
•  Inhalation and drinking water unit risks

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Exposure Assessment

n  Quantitative characterization of human exposure/contact with chemical hazards

n  Integrates information on ...

u  Chemical concentrations in environmental media
u  Human activity patterns
u  Population characteristics

n  Predicts magnitude of human exposure in the form of external dose in milligrams per
kilogram of body weight per day

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A Typical
Exposure Scenario

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The Nuts and Bolts of an Exposure Model

n  Estimation of intake of a chemical

n  Key components

u  Concentration of chemical in media
of interest
u  Media intake rate
u  Time components
•  Frequency
•  Duration
•  Averaging time
u  Body weight

Image Source: DFID – UK Department for International Development via fllckr.com. Creative Commons BY. 16
A Typical
Exposure Model

n  Intake of chemicals from drinking water, where ...

u  D = External dose (mg chemical / BW-day)
u  C = Chemical concentration (mg / L)
u  IR = Ingestion rate (L / day)
u  EF = Exposure frequency (unitless)
u  ED = Exposure duration (years)
u  BW = Body weight (KgBW)
u  AT = Averaging time (years)

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A Simple Exposure Scenario

n  Community water system gets water from an aquifer

contaminated with arsenic

n  Epidemiologic studies have shown that drinking-water

exposures to arsenic have been linked to carcinogenic
and non-cancer health effects

n  Determine dose to resident exposed to arsenic in

drinking water for a lifetime

n  Water sampling data for arsenic in community water

system

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Exposure Calculation Example

Average Conservative
Model input Units
estimate estimate
Concentration in water (C) mg/L 0.005 0.010
Ingestion rate (IR) L/day 1.41 2.30
Exposure frequency (EF) Unitless 1 1
Exposure duration (ED) Years 70 70
Body weight (BW) kgBW 71.8 62.3
Averaging time (AT) Years 70 70
Average daily dose mg/kgBW-day 1.00E-04 4.00E-04

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Risk Characterization

n  Integration of information from hazard identification, dose-response evaluation, and

exposure assessment steps

n  A risk characterization often includes ...

u  Prediction of carcinogenic risks and potential for non-carcinogenic hazard
u  Estimation of population burden (cancer)
u  Uncertainty discussion

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Quantitative Risk Characterization

n  Estimation of carcinogenic risks

u  Risk

u  Risk is unitless (units cancel)

u  Calculated from estimate of lifetime exposure
u  Interpretation
•  Risk of 1 x 10-6 is “one case per million persons exposed over a lifetime”

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Back to Our Drinking Water Example

n  Calculate cancer risk (average)

u  Risk = LADD x q*
u  Risk = (1 x 10-4 mg/kgBW-day) x (1.5 per mg/kgBW-day)
u  Risk = 1.5 x 10-4
u  Interpretation: approximately two persons per ten thousand people exposed to
arsenic in drinking water for a lifetime are expected to develop cancer

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Estimating Population Burden

n  Cancer burden estimation

u  No. cases = risk × population size
u  “The number of cancers expected in the population exposed to __________ over the
duration of a lifetime”

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Uncertainty Discussion

n  Why is it needed? Who uses it?

n  Qualitative or quantitative

u  Narrative
u  Formal uncertainty analyses

n  Presentation of uncertainty discussion

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Back to Our Drinking Water Example

n  How many cancers would we expect to see if the size of the affected community is
27,000 people?
u  No. cases = risk × population size
u  No. cases = (1.5 × 10-4) × (27,000)
u  No. cases = 4.05

n  Approximately four cases of cancer in this population assuming lifetime exposure

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Conclusions

n  Risk assessment is a useful tool in decision making

n  It draws from many different public health disciplines

n  The four main steps of risk assessments

1.  Hazard identification
2.  Dose-response assessment
3.  Exposure assessment
4.  Risk characterization

n  The outputs of a risk assessment typically include an estimate of cancer risk, non-
cancer hazard, population cancer burden, and an uncertainty discussion

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