Types of Risk Assessment CEL899: Environmental Risk Assessment 1st Semester 2012-13 Health-based risks Basic Concepts of Environmental Risk and Definitions • • Dr. Arun Kumar • (arunku@civil.iitd.ac.in) • For humans High chances of happening with small consequences; Chronic (i.e., long-term exposure) at low doses. Chemical exposure or microbial infection Ecological risks • • For aquatic species and physical environment Due to human interaction or natural actions on environment, such as oil spills or hurricane Department of Civil Engineering Indian Institute of Technology Delhi, Hauz Khas (India) August 16, 2012 Source, Medium, and Receptor Source • Medium Medium Receptor 1. 2. 3. • • • • Cyclic in nature as receptors also contribute to source and medium. August 16, 2012 Water Air Soil Food • • • Humans, aquatic species, Physical environment 4. (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 3 • Background risk (Rbkgd): August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 4 Total Risk • Total Risk (Rtotal): – This is the risk what people are exposed to from a given medium (such as water, air, soil, etc.) • Incremental risk (Rincr): – This is the risk due to addition of an external pollutant in the medium or occurrence of any event (events such as oil spill, contamination of water with poison, release of carbon monoxide gas in a closed room) (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) Exposure Route Water Ingestion route (say drinking of water) Air Inhalation route (say breathing of air) Soil Ingestion route (say eating of soil from hand or from food, etc. Food Ingestion route (say eating of leafy or root vegetable and fruits) Background, Incremental, and Total Risk August 16, 2012 2 Medium ----- Exposure Route Oil spill or any other accident Natural minerals Industry Humans • • • • (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 5 – This is the total risk a person or any receptor is exposed from a given medium – It represents both background and incremental risk Rtotal = Rbkgd + Rincr August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) (Eq. 2) 6 1 Acceptable Risk Acceptable Risk-Notation • Acceptable Risk (Racceptable): – This is the allowable risk a particular contaminant can result in on any receptor. – It is used to compare if Rtotal is higher or smaller than the Racceptable risk estimate. – Calculate risk ratio (“r”) and compare it with 1. r= Risk ratio • • August 16, 2012 – If exposed population (P) = 1000, it means that excess risk is allowable for = [(10-6)(person/person)]*(1000 person) = 1/1000 (i.e., 0.001 additional cases of cancer ) (or 1 out of 1000 people are expected to have excess cancer risk.) Rtotal (Eq. 3) Racceptable No concern ( r<1) Concern (r>1) (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) • Say, acceptable risk over life time = 1 :10,00,000 (i.e., one in a million) => Out of one million exposed, the risk of getting a particular effect in excess is acceptable for only one person over a lifetime. 7 August 16, 2012 Problem 1 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 8 Problem 1: Solution • In U.S. excess lifetime risk of getting a cancer is 1×10-6 (i.e., acceptable risk) and background risk of getting a cancer is say 1×10-5 . • (2) Calculation of risk ratio r= (1.1×10-6)/ (1×10-6) = 1.1 >1 (=> concern) (answer) – Calculate total risk of getting a cancer? – Calculate risk ratio? Solution: (1) Here, Incremental risk of getting a cancer = 1×10-6 Background risk of getting a cancer = 1×10-5 So, total risk of getting a cancer (using Eq. 2) = (1×10-5) +( 1×10-6) = 10-6 (1+10) =1.1×10-5 (answer) August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 9 August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 10 Problem 2: Solution Problem 2 Demand type Ghat 1 Ghat2 Background waterborne risk 1:10,000 (i.e., 10-4) 1:10,000 (i.e., 10-4) The WWTP discharges 103 virus particles/100 mL after Ghat 1 (which are pathogenic). Say, a person baths at Ghat 1 (upstream of a discharge point) and also baths at Ghat 2 (downstream of the discharge point). Background risk of getting a waterborne disease = 1:10,000 (i.e., 10-4) Incremental waterborne risk 0 (as WWTP discharge Say X (as WWTP discharge will can not influence the affect downstream water quality) upstream water Here, X >0 (i.e., positive) quality) Total waterborne risk =Background risk incremental risk =10-4+0 =10-4 Which ghat can pose higher total risk to a person? Comment Here, Ghat 2 will pose higher risk than Ghat 1 as Ghat 2 water quality is affected by WWTP discharge. WWTP discharge (wastewater effluent discharge) River “AA” Ghat 1 August 16, 2012 Ghat 2 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 11 August 16, 2012 + =Background risk + incremental risk =10-4+X =X+10-4 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 12 2 Overall risk ratio for environment is given by: Risk Estimation for Environment with Different Receptors Say our environment consists of humans, aquatic life, and physical environment (say river) and we want to do environmental risk assessment. We need to develop risk ratio for all three receptor types and then use them together to come up with overall environmental risk ratio estimate. Receptor type Total Risk Acceptable Risk Risk ratio Humans Risktotal,H Riskacceptable,H rH Aquatic life Risktotal,aq Riskacceptable,aq raq Physical environment (say for river) Risktotal,river Riskacceptable,river Rriver August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) Nr renvt = Renvt ∑w r = w r + w r i i i =1 Risk ratio for environment 11 2 2 + ... (Eq. 4) wi Importance weights for different receptors (say wH for humans, waq for aquatic species) ri Risk ratio for different receptors (say rH for humans, raq for aquatic species) Nr Total number of receptors If renvt < 1 => no concern If renvt > 1 => concern. 13 August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 14 Slope Factors (For carcinogens, i.e., substance which can cause cancer) Overall risk ratio for environment with three receptors=> Slope Factor = Response/Dose Receptor type Risk ratio Weightage Risk ratio * weightage Humans rH wH rH * wH (say A) Aquatic life raq waq raq * waq (say B) Physical environment for river) rriver wriver rriver * wriver (say C) Response (or risk) Dose (mg/d/kg body weight) (say • Overall risk ratio renvt = A+B+C for environment • • (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) Slope factor (SF) is also known as carcinogen potency factor. – Depends on medium under consideration. So SF for say inhalation exposure route can not be used for ingestion rate. If renvt < 1 => no concern; and If renvt > 1 => concern August 16, 2012 Say = [0.001 risk / (mg/d/kg body weight)] 15 For example: chloroform is a carcinogen with slope factor (oral, i.e., for ingestion route) = 6.1×10-3 Source: www.epa.gov/iris (Integrated Risk Information System) August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 16 Acceptable Daily Intake (For non-carcinogens, i.e., substance which cannot cause cancer) Reference Concentration (For noncarcinogens, i.e., substance which cannot cause cancer) • Acceptable daily intake • This is denoted as RfC and it represents value for which no effect is observed and a chemical concentration is within safe limit (Source: www.epa.gov/iris). • This can be used to calculate acceptable daily intake value = Reference concentration in water (mg/L)*water ingestion rate (L/day) (Eq. 5a) • Or Acceptable daily intake = Reference concentration in air (mg/m3)*air inhalation rate (m3/day) (Eq. 5b) August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 17 August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 18 3 Stages of Risk Assessment Stages of Risk Assessment • Hazard Identification– Defining hazard and nature of harm Hazard Identification • Exposure assessmentDose-response assessment Exposure assessment – Determination of concentration in environment and estimation of ingestion or inhalation rate of a contaminant • Dose-response assessment- Risk characterization – Quantification of effect due to exposure of a particular contaminant. A relationship between dose and response is used. • Risk characterization– Estimating of the potential impact of a hazard based on the severity of its effects and the amount of exposure. August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 19 August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 20 Hazard Identification CEL 899- Environmental Risk Assessment • Hazard– A descriptive term; – Refers to intrinsic capability of the waste or a contaminant to cause harm and it is a source of risk. • Depends on – Toxicity, – Mobility and persistence in medium under consideration – For example: Arsenic can cause greater chances of excess cancer from ingestion route than from inhalation route. Hazard Identification Dr. Arun Kumar arunku@civil.iitd.ac.in • A waste or contaminant is not harmful or causes no risk unless the exposure is occurred through a medium. Department of Civil Engineering Indian Institute of Technology Delhi, Hauz Khas (India) August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 22 Data Needs during Hazard Identification Process Hazard Identification • This process examines the data for all contaminants detected at a site and consolidates the date to determine chemicals-of-concern (or pathogens-of-concern). • This process helps in knowing spatial and temporal distribution of concentration over space. 1. History of the contaminated site or medium 2. Land use of the medium 3. Contamination levels in media (air, groundwater, surface water, soilds and sediments) 4. Environmental characteristics affecting fate and transport of chemicals and microorganisms – Geologic, hydrologic, atmospheric, topographic, etc. 5. Potentially affected receptor (humans, aquatic species, physical environment) August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 23 August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 24 4 Data Needs during Hazard Identification Process 6. Data from short-term tests in living organisms Grouping of animal and human data into different groups: 7. Data from long-term animal studies 1. 2. 3. 4. 5. 8. Data from human studies August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 25 EPA Categories for Carcinogenic Groups D No classification E No evidence B2 No evidence in humans C Possible carcinogen Case: Carcinogenicity August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 26 Initial Screening Procedure-Steps 1. Sort the contaminant data by medium (say groundwater, soil, surface water) for different types of contaminants B Probable carcinogen B1 Linked human data Sufficient evidence of carcinogenicity Limited evidence of carcinogenicity Inadequate evidence No data available No evidence of carcinogenicity A Human carcinogen 2. Tabulate mean and range of concentration values for all contaminants observed at the site 3. Identify the reference concentration (for noncarcinogens); slope factor (for carcinogens) for each potential exposure route, and 4. Calculate toxicity score for each contaminant in each medium. August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 27 Formula for calculating toxicity scores for chemicals For carcinogens TS = C max × SF (1a) (1b) Toxicity score Cmax Maximum concentration of a chemical RfC Reference concentration (chronic, i.e., for long-term exposure) (only for non-carcinogens) (source: www.epa.gov/iris/) SF Slope factor (or carcinogenic potency factor) (only for carcinogens) (source: www.epa.gov/iris/) (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 28 Following chemicals are found from a contaminated site. Rank these chemicals from high to low using toxicity as a criterion (for a oral ingestion route). TS August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) Class Problem 1-Noncarcinogenic Chemicals For non-carcinogens C TS = max RfC August 16, 2012 29 Chemical Cmax (mg/kg) Oral RfC Calculated toxicity score (mg/kg) (using Eq. 1a on Slide 9) Chlorobenzene 6.4 2×10-2 =6.4/ [2×10-2] =320 Chloroform 4.1 1×10-2 =4.1/ [1×10-2] =410 1,2Dichloroethane Not detected at site Not applicable Not applicable August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 30 5 Class Problem 1 contd. Class Problem 1-Carcinogenic Chemicals Total toxicity score = sum of all individual toxicity scores (eq. 2) Chemical Calculated toxicity score (using Eq. 1) (from Slide 9) Ratio (toxicity score/Total toxicity score) Chlorobenzene =6.4/ [2×10-2] =320 =[3.2×102]/[7.3×102] =0.4384(rank 2) Chloroform =4.1/ [1×10-2] =410 =[4.1×102]/[7.3×102] =0.5616 (rank 1) Not applicable Not applicable 1,2-Dichloroethane =(3.2×102)+(4.1×102) =(7.3×102) (from Eq. 2) Total toxicity score August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 31 Class Problem 1 contd.-Carcinogenic Chemicals Following chemicals are found from a contaminated site. Rank these chemicals from high to low using toxicity as a criterion (for a oral ingestion route). Chemical Cmax (mg/kg) Oral SF [1/(mg/kg)] Chlorobenzene 6.4 Not applicable (not a Not applicable carcinogen) Chloroform 4.1 6.1×10-3 1,2Dichloroethane Not 9.1 ×10-2 detected at site August 16, 2012 Calculated toxicity score (using Eq. 1b on slide 9) =4.1* [6.1×10-3] =2.5×10-2 Not applicable (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 32 Calculated Toxicity Score-Chloroform Total toxicity score = sum of all individual toxicity scores Chemical Chlorobenzene Chloroform 1,2-Dichloroethane Total toxicity score August 16, 2012 Calculated toxicity score (using Eq. 1b on Slide 9) Ratio (toxicity score/Total toxicity score) Not applicable Not applicable 2.5×10-2 =[2.5×10-2]/[2.5×10-2] =1.00 (rank 1) Not applicable Not applicable 33 Screening for microorganisms Campylobacter jejuni E.coli O157:H7 Salmonella spp. Shigella spp. (B4 and A21 strains pooled) Vibrio cholerae August 16, 2012 Dose-response ratio (alpha/beta) References 0.0191 Haas et al. (1999); Teunis et al.(1996) × 1.781×10 4.899×10 2.5×10-2 August 16, 2012 Dose-response ratio (alpha/beta) Rank based on doseresponse ratio (from high to low value) Campylobacter jejuni 0.0191 1 (highest concern) Salmonella spp. Haas et al. (1999) -5 Haas et al. (1999) -3 Haas et al. (1999); Soller et al. (2004) × 1.76 10-9 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 34 Pathogen E.coli O157:H7 0.099 10-6 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) Screening for microorganisms-Contd…. Rank microorganisms based on “dose-response ratio” parameter from low to high Pathogen As a carcinogen 4.1×102 Here, chloroform acts as both carcinogen as well as noncarcinogens. ⇒There are two values for toxicity scores. ⇒For ranking chloroform, use high toxicity score value to include both aspects of chloroform. =(2.5×10-2) =(2.5×10-2) (using Eq. 2 on slide 11) (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) As a non-carcinogen Shigella spp. (B4 and A21 strains pooled) Vibrio cholerae Teunis et al.(1996) 35 August 16, 2012 × 1.781×10 (=0.000018) 4.899×10 10-6 0.099 (=0.000000) 4 (lowest concern) -5 3 -3 2 (=0.004899) × 1.76 10-9 (=0.00000) (approx.) (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 4 (lowest concern) 36 6 So many contaminants…how to handle all of them From overall pool of contaminants to pool of priority contaminants Overall pool of all contaminants Pool of screened contaminants Pool of screened contaminants Overall pool of all contaminants N3 Pool of priority contaminants Number of contaminants reduces due to use of multiple sequential criteria------ > Pool of priority (selected) contaminants August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 37 August 16, 2012 Use of Surrogate chemicals or Indicator Microorganisms during Hazard Identification Process (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 38 CEL 899- Environmental Risk Assessment 1. Surrogate chemicals or indicator microorganisms • Used to characterize different chemicals and microorganisms 2. Criteria for selection: • • • Environmental Risk Zonation It should be most toxic persistent and mobile The most prevalent in terms of spatial distribution and concentration Those involved in the more significant exposures Dr. Arun Kumar arunku@civil.iitd.ac.in Department of Civil Engineering Indian Institute of Technology Delhi, Hauz Khas (India) August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 39 Class Problem 1Risk = Severity * Probability (loss) Risk • Risk is a function of severity and probability of loss due to happening of an event or en exposure. Calculate risk estimates for following activities: Table 1 Activity • Risk = Severity * Probability of loss • = (S)*(P)=K Severity of outcome (worker-days lost) Probability of outcome Risk (=worker-days lost)=K A 20 0.1 =20*0.1=2.0 (K1) B 10 0.2 =10*0.2=2.0 (K2) C 30 0.3 =30*0.3=9 (K3) Here, K1= K2 < K3 August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 41 August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 42 7 Severity versus Probability (i.e., “Risk Plane”) Risk=Severity * Probability = Say K Figure 1 Severity (S) Region 2 Region 3 Increasing K values (K1 < K2<K3) Region 4 K3 = Risk3 Region 1 K1 = Risk1 Never High • See that K1 < K2<K3 Probability of happening the severity (P) August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 43 • As we go up from K1 to K3, risk value increases (as indicated by the direction of arrow in Fig. 1) (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 44 • Region 4: – The region with high risk value and have all those combinations of “S” and “P” which can result in high risk value (See upper right corner of the Fig. 1) – “Not acceptable region” 45 • Region 3: – The region with medium risk value (K2>K1 and K2< K3) and have all those combinations of “S” and “P” which can result in medium risk value (See this region between regions 2 and 4 in Fig. 1) – “Provisionally acceptable region” August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 46 • Risk evaluation: – For worst case credible case; not for worst conceivable case – Otherwise it might not represent the worst case (i.e., sensitive sub-population, say children, elderly, and pregnant women) • Risk plane • Region 2: – The region with medium risk value, higher than that in Region 1 – “Acceptable region” August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) – The region with small risk value and have all those combinations of “S” and “P” which can result in small risk value (see lower left corner of the Fig.1.) – “Safe region” 1 (below K1 line) 2 (between K1 and K2) 3 (between K2 and K3) 4 (above K3 line) August 16, 2012 August 16, 2012 • Region 1: • See fours regions: – Region – Region – Region – Region – When severity is high, probability of happening that effect is low (i.e., happens only for the extreme case) – The “Never” value of P happens only for asymptotically high value of “S” – The “High” value of P can happen for very small value of “S” – Both of these cases are examples of “Extreme events” • Lines with constant “R” or “K” values are called “Iso-risk” line (i.e., line with equal risk at every point (S, P) of this line.) K2 = Risk2 Line with equal “K” values • The general trend: (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 47 – Generally used for illustration purposes and also for policy making (i.e., for developing guidelines, convention, and acceptable limits for risk assessment) – For conducting “Preliminary Hazard Analysis” – For developing “Risk Assessment Matrix” August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 48 8 Development of Risk Assessment Matrix Step 2: Develop “Risk Plane” into matrix of different cells (i.e., zoning) (the matrix = “Risk Assessment Matrix”) Step 1: Subjective classification of severity and probability for different targets (our case: humans) Subjective levels Severity Negligible < marginal <critical <catastrophic Probability Impossible <improbable< remote< occasional<probable <frequent Probability levels are defined for certain exposure levels August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 49 Guidelines 1. Don’t make too many cells. 2. Limit risk zoning to desirable categories of risk resolution August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 50 Risk Assessment Matrix Table 2 Severity of consequence Probability of mishap F (Impossible ) E (Improbable ) D (Remote) C (Occasional) B (Probable) A (Frequent) I (Catastrophic) II( Critical) III (Marginal) IV (Negligible) Zone 1: “Avoided” Zone 2: “Accepted by waiver” Zone 3: “Routinely accepted” 4(severity levels)* 6 (probability levels) =>24 cells are optimum without much confusion August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 51 August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 52 • In Table 2=> • See different classes of probability of mishap from “F” to “A” (i.e., 6 levels) – Here, probability of mishap increases as we go towards level “A” • See different extents of severity of consequence from level “I” to “IV” (i.e., 4 levels) – Here, severity of loss increases as we go towards level “I” • Now, we have a risk matrix (i.e., Table 2) with 24 cells showing different combinations of “S” and “P” levels. – Known as “Risk Assessment Matrix with 24 cells” • Here, we used “Risk Plane” (Figure 1 from Slide #4) and divided into different levels of “S” and “P”, and thus we created a risk assessment matrix. – This is called “Zoning of the risk plane”. • So we have 6*4= 24 cells and total of 24 combinations resulting in 24 risk values. August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 53 August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 54 9 •In Table 2=> Advantages and Limitations of Risk Assessment Matrix •Black colour region “Zone 1” •=> Imperative to take action to reduce risk levels •Grey colour region “Zone 2” • => Operation requires written communication for limited time exposure by management •White colour region “Zone 3” •=> Operation permissible and no significant risk Transition from Zone 1 -> Zone 2-> Zone 3 (don’t jump from Zone 1 to Zone 3) August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 55 •Advantages •A good tool for representing interrelationship of severity and probability of happening the severity •Avoids unknowingly selecting intolerable and senseless risk •Helps in making operation-based decisions for optimum use of resources •Limitations •It does not help in identifying hazard. •It can be used only for comparative purposes. It can not be used for risk quantification, unless data is available. August 16, 2012 (C) Dr. Arun Kumar, Civil Engg. IIT Delhi (India) 56 10