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Risk Assessment Vs Exposure Assessment - the Future ?
Tom Germann, CIH
Naval Hospital, Jacksonville FL
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Major Information Sources
• Risk Assessment Principles For the Industrial Hygienist - Jayjock, Lynch and Nelson, AIHA Press
• A Strategy For Assessing And Managing Occupational Exposures - Mulhausen and Damiano, AIHA Press
• Symposium on Risk Assessment - AIHA, New Orleans, 1999
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The Practice Of Industrial Hygiene
• Classical
• OSHA Driven
• Downsized
• Deregulated
?
• Avoid Worker’s Comp
Do The Right Thing
• Avoidance Of Penalties
• Expanded To Environmental
• Profitability, Enhance Performance, “Bottom Line”
?
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RISK ASSESSMENT
A logical, objective and quantitative approach to analyzing and interpreting data with the purpose of PREDICTING potential adverse effects.
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RISK ASSESSMENT
A formal way to CALCULATE risk so that informed decisions can be made.
Jayjock, et al
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Risk Assessment
Risk = Probability of Health Effect . Level Of Exposure Unit Exposure
Risk = Probability of Health Effect . Absorbed Dose Absorbed Dose
Risk = Exposure . Exposure Limit
Jayjock, et al
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Dose-Response Models
• Threshold Assumed
• No Threshold Assumed
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Monty Herr
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Monty Herr
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Monty Herr
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OCCUPATIONAL
INDUSTRIAL
HYGIENE
Recognition
Evaluation
Control
Hazard Communication
ENVIRONMENTAL
RISK
ASSESSMENT
Hazard Identification
Exposure Assessment
Toxicity Assessment
Risk Characterization
Risk Management
Risk Communication
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OCCUPATIONAL
INDUSTRIAL
HYGIENE
OELsPEL
TLV
STEL
Ceiling Limit
WEEL
Exposure Profile
Acceptable Risk = 10-3
ENVIRONMENTAL
RISK
ASSESSMENT
RfDChronic/Subchronic
Oral/Inhalation/Dermal
SLOPE
CDI - LCR/NHQ Lifetime Cancer Risk/Noncancer Hazard Quotient
Acceptable Risk = 10-6
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OCCUPATIONAL
INDUSTRIAL
HYGIENE
Adult, healthy
30 years
Trained
8 hrs/day
5 days/wk
Inhalation, Skin, Ingest
Physical Agents Averaging Times
ENVIRONMENTAL
RISK
ASSESSMENT
Young, Old, Infirmed
Lifetime
Unaware/Uneducated
24 hrs/day
7 days/wk
Pathways - water, soil, air
Chronic
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RISK ASSESSMENT
Measuring risk is scientific. Judging the acceptability of risk is a value judgement.
Jayjock, et al
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PUTATIVE RISK
ACCEPTABLE RISK
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RISK ASSESSMENT
Risk assessment is not an objective scientific process; facts and values frequently merge when we deal with issues of high uncertainty; cultural factors affect the way people assess risk.
Sheila Jasanoff
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RISK ASSESSMENT
Risk assessment is always clouded in uncertainty.
Jayjock, et al
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ASTM - RBCA Tiered Approach To Risk Assessment
• Tier 0 - Expert Judgement
• Tier 1 - Look-up Table
• Tier 2 - Screening Level Models and
More Data
• Tier 3 - Complex Survey
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Iterative (Tiered) Approach To Risk Assessment
YES/MAYBE
PROBLEM? NO STOP
YESCONTROL
PROBLEMATIC?
NEXT TIEREVALUATION
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AIHA Exposure Assessment Strategy
1. Start - Establish strategy
2. Basic Characterization
3. Exposure Assessment
4. Further Information Gathering
5. Health Hazard Control
6. Reassessment
7. Communication/Documentation
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START
Basic Characterization
Exposure Assessment
Acceptable Uncertain Unacceptable
Reassessment
Further InfoGathering
Control
EXPOSURE ASSESSMENT STRATEGY
Mulhausen and Damiano
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AIHA Exposure Assessment Strategy
1. Start - Establish strategy
2. Basic Characterization
3. Exposure Assessment4. Further Information Gathering
5. Health Hazard Control
6. Reassessment
7. Communication/Documentation
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AIHA Exposure Assessment Strategy
3. Exposure Assessment
– Define Similar Exposure Groups (SEGs)
– Define Exposure Profiles
– Make Judgements on Acceptability of the
Exposure Profile For Each SEG
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EXPOSURE ASSESSMENT
Mulhausen and Damiano
Establish SEGs
Define Exposure Profile
Select/DefineOELs
Compare
OELand its
Uncertainty
Exposure Profileand its
Uncertainty
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Comparative Hazard MatrixPrioritizing SEGs
4 4 8 12 16
3 3 6 9 12
2 2 4 6 8
1 1 2 3 4
1 2 3 4
Exposure Rating
Healt
h E
ffect
R
ati
ng
Mulhausen and Damiano
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AIHA Exposure Rating CategorizationBased on Arithmetic Mean Of Exposure Profile
4
3
2
1
>LTA - OEL
50% - 100% LTA-OEL
10% - 50% LTA-OEL
<10% LTA-OEL
Long-term average occupational exposure limit (LTA-OEL) is the acceptable average concentration of an environmental agent exhibiting cumulative adverse effects
Mulhausen and Damiano
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AIHA Exposure Rating CategorizationBased on Estimate Of 95th Percentile Relative To OEL
4
3
2
1
> 5% exceedance of the OEL (95th percentile > OEL)
>5% exceedance of 0.5 x OEL (95th percentile between 0.5 x OEL
and 1.0 x OEL)
>5% exceedance of 0.1 x OEL (95th percentile between 0.1 x OEL
and 0.5 x OEL)
Little to no exceedance of 0.1 x OEL (95th percentile < 0.1 OEL)
Mulhausen and Damiano
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AIHA Exposure Assessment Strategy
1. Start - Establish strategy
2. Basic Characterization
3. Exposure Assessment
4. Further Information Gathering5. Health Hazard Control
6. Reassessment
7. Communication/DocumentationMulhausen and Damiano
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AIHA Exposure Assessment Strategy
4. Further Information Gathering
– Exposure Monitoring
– Exposure Modeling
– Biological Monitoring
– Toxicology Data Generation
– Epidemiological Data Generation
Mulhausen and Damiano
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Prioritizing Information Gathering
16 0 16 32
12 0 12 24
9 0 9 18
8 0 8 16
6 0 6 12
4 0 4 8
3 0 3 6
2 0 2 4
1 0 1 2
Certain0
Uncertain1
Highly Uncertain2
Uncertainty Rating
Healt
h E
ffect
R
ati
ng
Mulhausen and Damiano
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START
Basic Characterization
Exposure Assessment
Acceptable Uncertain Unacceptable
Reassessment
Further InfoGathering
Control
EXPOSURE ASSESSMENT STRATEGY
Mulhausen and Damiano
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EXPOSURE ASSESSMENT
Mulhausen and Damiano
Establish SEGs
Define Exposure Profile
Select/DefineOELs
Compare
OELand its
Uncertainty
Exposure Profileand its
Uncertainty
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The Practice Of Industrial Hygiene
• Classical
• OSHA Driven
• Downsized
• Deregulated
• Iterative
• Avoid Worker’s Comp
Do The Right Thing
• Avoidance Of Penalties
• Expanded To Environmental
• Profitability, Enhance Performance, “Bottom Line”
• Systematically reduce uncertainty and prioritize effort
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The Future ???
• The World - “ Are PELs relevant to global
corporations?”
• DOD/Navy -
– Need Better RAC system
– DOEHRS for IH?
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The Future ???
• The IH Profession
– Life Cycle Analysis - integrate human and
ecotoxicology, exposure assessment, recycling and
power consumption
– Sensitive populations will drive the scientific and
regulatory process
• GMF (genetically modified food)
• Office of Children’s Health “Kiddie Act”
• FQPA (Food Quality Protection Act) [ pesticides]
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The Future ???
• The IH Profession (cont’d)
– OELs - Many are 30 years old. Expect 5-100
fold lower values for some
– REA (Retrospective Exposure Assessment) -
several have occurred in last 7 years - more to
come
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Take Home Points
• There is an historical and ongoing link
between occupational exposure assessment
and environmental risk assessment which
will continue to have a significant effect on
the practice of industrial hygiene
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Take Home Points
• Risk assessment/risk management is a merger
of science and judgement
• The use of risk assessment requires the
admission of some level of acceptable risk
• Don’t do risk assessment if you are not going
to make a decision
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Take Home Points• We need to be more quantitative and
systematic in our approach to exposure assessments
• We need to acknowledge and manage uncertainty in our assessments
• We can do both of the above and improve the efficient use of limited resources by adopting an iterative approach to our decision making