1. Risk Assessment

2. Risk Assessment Topics
What is Risk?
Risk, Hazard and Exposure
How is Risk Expressed?
Risk Categories
What is Risk Assessment?
Risk Assessment Applications

3. What is Risk?
Risk is the probability or likelihood of an adverse effect due to some hazardous situation
Safety is the complement of risk, or the probability that an adverse effect will not occur
Risk = f ( Hazard, Exposure)
Magnitude or severity of risk are a function of the type of harm i.e. Hazard and the extent or likelihood of Exposure

4. Risk and Hazard Determination
Chemical A Pipe 1
Chemical A Pipe 2
Chemical A Pipe 3
Leaking Pipe

5. Risk = Hazard * Exposure
Chemical A Pipe 1
Chemical Pipe 2
Chemical A Pipe 3
Leaking Pipe
Risk = Hazard * Exposure

6. Hazard : Potential for creating undesired adverse consequences.
In this case it remains same as chemical flowing through pipe is same.
Chemical A Pipe 1
Chemical A Pipe 2
Chemical A Pipe 3
Leaking Pipe

7. Exposure : Vulnerability to hazard
Pipe 2 poses greatest risk of exposure due to leakage.
Chemical A
Pipe 2
Chemical A Pipe 3
Chemical A
Pipe 1
Leaking Pipe

8. How is risk expressed?
Probability of adverse effects associated with a particular activity
Unitless
From 0-1
E.g. 1x One in 10
1x One in 100

9. Factors in Risk Acceptability
Voluntary
Smoking
Bungee Jumping
Diet
Nonvoluntary
Risk resulting from uncontrollable actions of others (Occupational exposure, pesticide residues)
Natural disasters
Degree of control
Magnitude of the outcome
Awareness
Catastrophic Potential
Group involvement
Cost of alternatives

10. Risk Values Activity Annual Risk Smoking 10 cigarettes/day 1 x 10-3
Motor vehicle accidents x 10-4
Manufacturing work accident x 10-5
Pedestrian hit by automobiles x 10-5
Drinking two beers/day x 10-5
Person in a room with a smoker x 10-5
Peanut butter (4 teaspoons/d) x 10-6
Drinking water with
EPA limit of Trichloroethene x 10-9

11. What is Risk Assessment?
Analytical tool for studying situations that could result in adverse consequences
Qualitative and quantitative assessment of environmental status
Process to identify and quantify the risk and select necessary action

12. Risk Assessment Applications Identification of any ecological risk
Identification of the need for additional data collection
Site remediation alternative selection
Establishment of cleanup standards

14. Compartmentalized Hazardous Waste
Groundwater
Compartmentalized Hazardous Waste
Leaching of waste
Increasing migration distance with time
Migrating contaminant Plume

15. Remediation Options?

16. In place containment, groundwater pumping and retreatment alternative
No Action
In place containment, groundwater pumping and retreatment alternative
Excavation, Incineration/re-landfilling

17. Groundwater contamination is definite
No Action
No capital cost
Groundwater contamination is definite

18. In place containment, groundwater pumping and retreatment alternative
Volatilization and Particulate migration
Creating a barrier to prevent or extend the groundwater contamination around the site
Construction of containment facility
Air Stripping
Volatilization

19. Excavation Incineration/ Re-Landfilling
Particulate migration / Volatilization
Vehicular transport to incinerator
Re- Landfilling
Stockpiling at incinerator
Incinerator
Flue Gas Emissions

20. Process

21. Risk Assessment Process
Hazard Identification
Dose Response
Exposure Assessment
Risk characterization

22. Hazard Identification
Toxicity assessment determines whether exposure to a chemical, physical, or biological agent can cause an increase in the incidence of an adverse effect.
Necessary condition for a health or safety risk
Physical, metabolic, and chemical properties of the agent;
Potential routes of exposure; toxicological effects; results of animal studies (dose-response); and site characteristics

23. Hazard Identification – Toxicity Score
Ranking of chemicals from contaminated sites depending upon their toxicity scores
Help in identifying contaminants with a significant impact at the site
Need data from the contaminated site

24. Hazard Identification – Toxicity Score – Non=carcinogens
Toxicity score (TS) = Cmax / RfD Cmax = Maximum Concentration RfD = Chronic Reference Dose i.e. acceptable daily intake TS = Toxicity score

25. Hazard Identification – Toxicity Score - Carcinogens
Toxicity score (TS) = Cmax * CSF Cmax = Maximum Concentration CSF = Cancer Slope factor TS = Toxicity score

26. Hazard Identification – Toxicity Score – Example Landfill ABC
Chemicals
Air (mg/m3)
Groundwater (mg/L)
Soil (mg/kg)
Mean
Max
Chlorobenzene (NC)
4.09E-08
8.09E-08
2.5E-04
1.10E-02
1.39E+00
6.40E+00
Chloroform (C, NC)
1.12E-12
3.12E-12
3.3E-04
7.60E-03
1.12E+00
4.10E+00
1,2-Dichloroethane (NC)
1.12E-08
2.40E-08
2.1E-04
2.00E-03 ND
BEHP (C, NC)
3.29E-07
8.29E-07
1.03E+02
2.30E+02
ND – Not Detected; C= Carcinogenic, NC = Non-carcinogenic

27. Hazard Identification – Toxicity Score
Chemicals
RfD
( mg/kg-day)
Soil (mg/kg)
Mean
Cmax
Chlorobenzene
2.00E-02
1.39E+00
6.40E+00
Chloroform
1.00E-02
1.12E+00
4.10E+00
1,2-Dichloroethane NA ND
BEHP
1.03E+02
2.30E+02
ND – Not Detected; NA-Not Applicable
Rank the non-carcinogenic chemicals for soil

28. Hazard Identification – Toxicity Score
Chemicals
RfD
( mg/kg-day)
Soil (mg/kg)
TS = Cmax/RfD
Rank
Mean
Cmax
Chlorobenzene
2.00E-02
1.39E+00
6.40E+00
320 3
Chloroform
1.00E-02
1.12E+00
4.10E+00
410 2
1,2-Dichloroethane NA ND
BEHP
1.03E+02
2.30E+02
11,500 1
ND – Not Detected; NA-Not Applicable
BEHP poses the greatest risk for the given site followed by chloroform and Chlorobenzene.

29. Hazard Identification – Toxicity Score
Selection of chemicals by TS method is followed by further evaluation which deals with other properties of that contaminant like mobility, persistence in environment, treatability etc. depending on the purpose of assessment.

30. Hazard Identification – Toxicity Score
Now try the same problems for carcinogens.
Also find RfD for the same contaminants in groundwater and air, on web and perform TS calculations

31. Risk Assessment Process
Hazard Identification
Dose Response
Exposure Assessment
Risk Characterization

32. Risk Assessment Process
Dose Response
How large a dose causes what magnitude of effect?

33. Dose-Response Assessment
Dose-response assessment is the process of characterizing the relation between the dose of target contaminant administered or received, and the incidence of an adverse health effect in exposed populations, and estimating the incidence of the effect as a function of human exposure to the agent.

34. Dose-Response Curve
Represents variations in response of receptor at different contaminant levels
Generally, increasing the dose of contaminant will result in a proportional increase in both the incidence of an adverse effect as well as the severity of the effect.
Quantitative relationship between exposure and toxic effects
Enables risk assessor to estimate a safe dose
Actual dose is compared with safe dose in risk assessment process

35. Dose-Response Curve No-Observed-Adverse-Effect-Level (NOAL)
Dose: mg chemical/kg of body weight
Response: % population affected by dose.
Curvature of dose response curve illustrates varying sensitivity of exposed population.
No-Observed-Adverse-Effect-Level (NOAL)
the greatest test dose level at which no adverse effect is noted
Lowest-Observed-Adverse-Effect-Level (LOAEL)
Lowest level at which an adverse effect is detected

36. Cancer Response-Dose Curve
Dose: mg chemical/kg of body weight
Response: % population cancer
Extrapolate to low dose/risk

37. Reference Dose
RfD: An estimate of daily exposure to the human population that is likely to be without appreciable risk of deleterious effects during a lifetime
Expressed as mg pollutant / kg body weight/day
Also expressed as Reference Concentration (RfC), mg/m3 37

38. Reference Dose RfD = NOAEL /(FAFHFSFLFD) Where:
NOAEL: No-Observed-Adverse-Effect-Level
FA: An adjustment factor to extrapolate from animal to human population
FH: Adjustment factor for differences in human susceptibility
FL: An adjustment factor applied when LOAEL is used instead of NOAEL
FS: An adjustment factor applied when data set is dubious or incomplete

39. Reference Dose - Problem
In a three month subchronic study in mice, the NOAEL for tris-(1,3-dichloro-2-propyl) phosphate was 15.3 mg/kg body weight per day; the LOAEL was 62 mg/kg at which dose abnormal liver effects were noted. If each of the adjustment factor is equal to 10, calculate the reference dose for chemical.

40. Reference Dose - Problem
Given: NOAEL = 15.3 mg/kg body weight per day LOAEL = 62 mg/kg (no need here as NOAEL is given) Calculate RfD using NOAEL and LOAEL RfD = NOAEL / (FA FH FS FLFD) Adjustment factors applicable for this problem are: FA, FH, Fs RfD = 15.3/(10*10*10) = mg/kg-day

41. Reference Dose - Problem
Using LOAEL : RfD = LOAEL/(FA FH FS FLFD) Adjustment factors applicable are : FA, FH, Fs and FL RfD = 62/(10*10*10*10) = mg/kg-day

42. Reference Dose - Problem
RfD = mg/kg-day (Using NOAEL)
RfD = mg/kg-day (using LOAEL)
The lowest of two values will be the reference dose for tris-phosphate i.e mg/kg-day

43. Reference Dose - Problem
Repeat the RfD calculations for tris-phosphate for which NOAEL was determined to be 22mg/kg-day and the LOAEL was found to be 44 mg/kg-day for increased weight of liver and kidneys in rat.

44. Risk Assessment Process
Hazard Identification
Dose Response
Exposure Assessment
Risk characterization

45. Deals with various exposure pathways for released contaminant
Exposure Assessment
Exposure Assessment
Deals with various exposure pathways for released contaminant

46. Exposure Assessment - Pathways
Source (e.g. landfill, lagoon)
Chemical release mechanism (e.g. leaching)
Transport mechanism (e.g. groundwater)
Transfer mechanism (e.g. sorption)
Transformation mechanism (e.g. biodegradation)
Exposure point (e.g. residential well)
Receptor
Exposure route ( e.g ingestion, inhale)

47. Exposure Assessment Means of Exposure
Community Exposure, i.e. exposure at workplace
Occupational Exposure, i.e. exposure at workplace

48. Exposure Assessment Routes of Exposure Lungs Exposure Dermal Exposure
(Skin)
Lungs Exposure
(Inhalation)
Ingestion

49. Exposure Assessment Process Work Surface Skin Air Inhalation Ingestion
Dermal Absorption

50. Inhalation/Ingestion Exposure Framework
Duration (Time)
Severity (mass/time)
Env. concentration (mass/volume)
Breathing/
Ingestion Rate (volume/time)
Frequency (no. exposures)
Period (time/exposure)

51. Dermal Exposure Framework
Exposure (mass)
Frequency (no. incidents)
Severity (mass/time)
Surface (area skin exposed)
Absorption (mass/area/incident)

52. NSP: Nanoscale particles

53. Calculation ( C x CR x EF x ED) I = --------------------------
(BW x AT)
I = Intake (mg/kg of body weight per day)
C = Concentration at exposure point (e.g. mg/L in water or mg/m3 in air)
CR = Contact Rate ( e.g L/day or m3/day)
EF = Frequency (day/year)
ED = Exposure Duration (yr)
BW = Body weight (kg)
AT = Averaging Time (days)

54. Standard Parameters for Calculating Exposure and Intake
Adults
Child Age (6-12)
Child Age ( 2-6)
Average Body Weight (kg) 70 29 16
Skin surface are (cm2)
18,150
10470
6980
Water Ingested (L/day) 2 1
Air breathed (m3/hour)
0.83
0.46
0.25
Retention rate (inhaled air)
100%
Absorption rate (inhaled air)
Soil ingested (mg/day)
100
200
Bathing duration (minutes) 30
Exposure frequency (days)
365
Exposure duration (years) 6 4

55. Intake Rate Calculation
Determine the chronic daily inhalation intake, by adults, of a non-carcinogenic chemical as a function of concentration in fugitive dust at a landfill ABC.

56. Intake Rate Calculation
( C x CR x EF x Ed x RR x ABS)
I = (BW x AT)
Air breathing rate for adults = 0.83 m3/hr
CR = 0.83 x 24 = m3/day
EF = 365 days
ED = 30 years ( For chronic exposure, non-carcinogen)
RR = 1, ABS = 1 ( Assumption in the absence of any data)
AT = 365 days x 30 years

57. Intake Rate Calculation
I = (C x x (365 x 30) x 1x1)/ (70 x (365x60))
I = m3/kg-day x C
C = Exposure point concentration (mg/m3)

58. Risk Assessment Process
Hazard Identification
Dose Response
Exposure Assessment
Risk characterization

59. Risk Characterization
Final step of risk assessment process
Integration of hazard identification, dose response assessment and exposure assessment.

60. Risk Characterization
Non-carcinogenic Risk
Carcinogenic Risk

61. Risk Characterization - Carcinogens
Risk = CDI x SF
Where:
CDI = Chronic daily intake (mg/kg-day) hazard assessment
SF = carcinogenic slope factor (kg-day/mg)

62. Risk Characterization - Carcinogenic
Calculate the average carcinogenic risk from chloroform due to dermal contact of soil by workers at the landfill ABC. From TS calculation table: C = 1.12 mg/kg From carcinogenic dose intake calculations I = 2.9 x 10-9 x C = 3.26 x 10-9 mg/kg-day SF for Chloroform = 6.1 x 10-3 Risk = 6.1 x 10-3 x 3.26 x 10-9 mg/kg-day Risk= 1.99 x 10-11

63. Risk Characterization: Non-carcinogenic
Normally characterized in terms of hazard index (HI)
HI = (CDI/RfD) where
CDI = Chronic daily intake (mg/kg-day)
RfD = Reference dose (mg/kg-day)
HI = Hazard Index (Unitless)
HI < 1.0 is acceptable

64. Risk Characterization: Non -carcinogenic
Calculate the hazard index for chlorobenzene, based on intake calculated for landfill ABC.
Solution:
HI = CDI/RfD
RfD = 2 x 10-2 ; CDI = 2.82 x 10-7
HI = 1.41 x 10-5 < 1 OK

65. Risk Management Regulatory action Decision to mitigate risk
Action level

66. Uncertainty
The risk assessment process is extremely conservative in nature and utilizes measurements which are uncertain.
Insufficient data or information gaps often exist in characterizing the potential risk of an agent, necessitating the need for assumptions or educated guesses.

67. Uncertainty
Use computational tools from the field of decision analysis to account for the uncertainties in the process
These tools allow risk to be expressed as a probability distribution rather than a single number which can then be used to make a more informed decision during risk management

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Last updated October 2008 by Dr. Reinhart