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

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Presentation on theme: "Risk Assessment. Risk Assessment Topics  What is Risk?  Risk, Hazard and Exposure  How is Risk Expressed?  Risk Categories  What is Risk Assessment?"— Presentation transcript:

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 Leaking Pipe Risk and Hazard Determination

5 Leaking Pipe

6 Hazard : Potential for creating undesired adverse consequences. In this case it remains same as chemical flowing through pipe is same.

7 Exposure : Vulnerability to hazard Pipe 2 poses greatest risk of exposure due to leakage.

8 How is risk expressed?  Probability of adverse effects associated with a particular activity  Unitless  From 0-1  E.g. 1x10 -1 - One in 10  1x10 -2 - 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 Activity Annual Risk Smoking 10 cigarettes/day 1 x 10 -3 Motor vehicle accidents 2 x 10 -4 Manufacturing work accident 8 x 10 -5 Pedestrian hit by automobiles 4 x 10 -5 Drinking two beers/day 4 x 10 -5 Person in a room with a smoker 1 x 10 -5 Peanut butter (4 teaspoons/d) 8 x 10 -6 Drinking water with EPA limit of Trichloroethene 2 x 10 -9 Risk Values

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



15 Remediation Options?

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

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

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

19 Excavation Incineration/ Re-Landfilling Vehicular transport to incinerator Stockpiling at incinerator Incinerator Re- Landfilling Particulate migration / Volatilization 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 C max = Maximum Concentration CSF = Cancer Slope factor TS = Toxicity score

26 Hazard Identification – Toxicity Score – Example Landfill ABC ChemicalsAir (mg/m 3 )Groundwater (mg/L) Soil (mg/kg) MeanMaxMeanMaxMeanMax Chlorobenzene (NC) 4.09E-088.09E-082.5E-041.10E-021.39E+006.40E+00 Chloroform (C, NC) 1.12E-123.12E-123.3E-047.60E-031.12E+004.10E+00 1,2- Dichloroethane (NC) 1.12E-082.40E-082.1E-042.00E-03ND BEHP (C, NC)3.29E-078.29E-07ND 1.03E+022.30E+02 ND – Not Detected; C= Carcinogenic, NC = Non-carcinogenic

27 Hazard Identification – Toxicity Score ChemicalsRfD ( mg/kg-day) Soil (mg/kg) MeanC max Chlorobenzene2.00E-021.39E+006.40E+00 Chloroform1.00E-021.12E+004.10E+00 1,2-DichloroethaneNAND BEHP2.00E-021.03E+022.30E+02 ND – Not Detected; NA-Not Applicable Rank the non-carcinogenic chemicals for soil

28 Hazard Identification – Toxicity Score ChemicalsRfD ( mg/kg- day) Soil (mg/kg)TS = Cmax/RfD Rank MeanCmax Chlorobenzene2.00E-021.39E+006.40E+003203 Chloroform1.00E-021.12E+004.10E+004102 1,2- Dichloroethane NAND NA BEHP2.00E-021.03E+022.30E+0211,5001 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  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 Dose-Response Curve

35  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/m 3

38 Reference Dose RfD = NOAEL /(F A F H F S F L F D ) Where: NOAEL: No-Observed-Adverse-Effect-Level F A : An adjustment factor to extrapolate from animal to human population F H : Adjustment factor for differences in human susceptibility F L : An adjustment factor applied when LOAEL is used instead of NOAEL F S : 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 / (F A F H F S F L F D ) Adjustment factors applicable for this problem are: F A, F H, F s RfD = 15.3/(10*10*10) = 0.015 mg/kg-day

41 Reference Dose - Problem Using LOAEL : RfD = LOAEL/(F A F H F S F L F D ) Adjustment factors applicable are : F A, F H, F s and F L RfD = 62/(10*10*10*10) = 0.0062 mg/kg-day

42 Reference Dose - Problem  RfD = 0.015 mg/kg-day (Using NOAEL)  RfD = 0.0062 mg/kg-day (using LOAEL) The lowest of two values will be the reference dose for tris-phosphate i.e. 0.0062 mg/kg-day

43 Reference Dose - Problem Repeat the R f D 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 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 Means of Exposure Occupational Exposure, i.e. exposure at workplace Community Exposure, i.e. exposure at workplace Exposure Assessment

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

49 Exposure Assessment Process Air InhalationIngestion Work Surface Skin Dermal Absorption

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

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

52 NSP: Nanoscale particles

53 ( 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/m 3 in air) CR= Contact Rate ( e.g L/day or m 3 /day) EF= Frequency (day/year) ED = Exposure Duration (yr) BW = Body weight (kg) AT = Averaging Time (days) Calculation

54 Standard Parameters for Calculating Exposure and Intake ParameterAdultsChild Age (6-12)Child Age ( 2-6) Average Body Weight (kg) 702916 Skin surface are (cm 2 )18,150104706980 Water Ingested (L/day)221 Air breathed (m 3 /hour)0.830.460.25 Retention rate (inhaled air) 100% Absorption rate (inhaled air) 100% Soil ingested (mg/day)100 200 Bathing duration (minutes) 30 Exposure frequency (days) 365 Exposure duration (years) 3064

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 m 3 /hr CR = 0.83 x 24 = 19.92 m 3 /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 19.92 x (365 x 30) x 1x1)/ (70 x (365x60)) I = 0.285 m 3 /kg-day x C C = Exposure point concentration (mg/m 3 )

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 Carcinogenic Risk Non-carcinogenic Risk Risk Characterization

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

68 Return to Home Page Last updated October 2008 by Dr. Reinhart

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