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National University of
Malaysia

Human Health Risk Assessment

Wan Zuhairi Wan Yaacob (Assoc. Prof, PhD)
Faculty of Science and Technology
National University of Malaysia
43600 Bangi, Selangor, MALAYSIA.
28-Jan-14

1
Risk Assessment

National University of
Malaysia

• Risk Assessment in daily life !!

28-Jan-14

2
2 types of Risk Assessment

National University of
Malaysia

1. QRA – Quantitative Risk Assessment
–

Risk = Likelihood x consequences

2. ERA – Environmental Risk Assessment
a) Human Health Risk Assessment (HRA)
•
•
•

Health related risk
Risk = hazard x exposure
(i) carcinogenic (ii) non-carcinogenic chemicals

Fukushima Daiichi
nuclear disaster

b) Ecological Risk Assessment (ERA)
•
•
28-Jan-14

Ecological risk at sites
Risk = hazard x exposure
3
Quantitative Risk

National University of
Malaysia

• Hazard
• Probability

RISK in Oil and Gas Industry
28-Jan-14

4
Risk Assessment

National University of
Malaysia

• Risk of particular event =
probability of that event to occur x
consequence of the event
• Consequence = damage to people,
property, economic activity, public
service, etc)
• Large earthquake: low probability but
high consequence
• Acceptable risk
– Minimum risk that people can
accept
– Eg. Driving a Car
28-Jan-14

5
National University of
Malaysia

28-Jan-14

6
National University of
Malaysia

Risk Assessment & Risk Management?

RISK
PERCEPTION

28-Jan-14

RISK
ASSESSMENT

RISK
MANAGEMENT

7
Risk Assessment (Risk Matrix)

National University of
Malaysia

E = Extreme risk; H = High Risk; M = Medium Risk; L = Low Risk

Example:
• Risk of travelling by car in Malaysia?
• Risk of travelling with an aeroplane
nowadays?
28-Jan-14

Example
• Risk of volcanic eruption in Malaysia?
• Risk of earthquake in Japan?
8
Concept of Human Health Risk (1)

National University of
Malaysia

Risk = hazard x exposure

28-Jan-14

9
National University of
Malaysia

Concept of Human Health Risk (2)
3

1

2

RISK : Source ------ Pathways ------ Receptors
28-Jan-14

10
Concept of
Source – Pathways - Receptors

National University of
Malaysia

SOURCE

RECEPTORS

RISK






28-Jan-14

PATHWAYS











YES
NO
NO
NO

11
National University of
Malaysia

Human Health Risk Assessment (HRA)

1

28-Jan-14

2

12
National University of
Malaysia

Oil Well Pump

28-Jan-14

13
National University of
Malaysia

Exposure Assessment

• Quantify contaminant intake at the point of
exposure
• Intake = I

(Intake)

28-Jan-14

14
Exposure Assessment

National University of
Malaysia

The General Equation for chemical intake is:-I = C x CR x EFD
• I = intake (mgkg-1d-1)
-------------– Mg/kg body weight per day
BW x AT
• Chemical related variable, C
– Chemical concentration; the average concentration contacted over the
exposure period (eg, mg/L water or mg/kg soil or PPM)
• Variables that describe the exposed population
– CR = contact rate; the amount of contaminated medium contacted per unit
time or event (eg. Litres/day)
– EFD = exposure frequency and duration, describes how often and how long
exposure occurs. Often calculated using two terms (EF & ED)
– EF = exposure frequency (days/year)
– ED = exposure duration (years)
– BW = body weight; the average body weight over the exposure period (kg) –
70kg (Adult 70kg ; infant (5 kg) ; children (10kg)

28-Jan-14

15
National University of
Malaysia

Exposure Assessment

•

28-Jan-14

I = C x CR x EFD
-------------BW x AT

Assessment-determined variable
– AT = averaging time OR total exposure time; period over which exposure is
averaged (days)
– (1) For evaluation of carcinogenic effects, AT = life expectancy for population
of concern (70 years in US) x 365 days/year
– (2) For evaluation of non-carcinogenic effects, AT = ED x 365 days/year

16
National University of
Malaysia

Toxicity values
• Animal studies
Rats

Uncertainty
factor(UF) or
safety factor
(SF)

Uncertainty
factor(UF) or
safety factor
(SF)

Toxicity value for
human

Feeding, inhalation testing

Cancer slope factor (SF)
Reference dose (RfD)

28-Jan-14

17
Toxicity values for Carcinogens

National University of
Malaysia

• Use slope factor (y = mx)
• There is no threshold
because exposure to any
level of a carcinogenic
chemical poses a probability,
however small, of generating
carcinogenic response.
• The curve passes through
the origin
28-Jan-14

18
National University of
Malaysia

(mg/kg/day)-1

28-Jan-14

19
No Observed Adverse Effect Level (NOAEL)

28-Jan-14

National University of
Malaysia

20
National University of
Malaysia

RISK CHARACTERIZATION

28-Jan-14

21
Determination of non-carcinogenic risk

National University of
Malaysia

• Represented by Hazard Quotient (HQ); the ration of
chronic daily intake to RfD:
HQ = I / RfD
•
•
•
•

HQ = hazard index (dimensionless)
I = the intake (TDI, mgkg-1d-1)
RfD = reference dose (mgkg-1d-1)
HQ <1.0 = acceptable risk for all contaminants and
routes of exposure
• HQ>1.0 = the receptors are exposed to the
contaminant
28-Jan-14

22
Determination of non-carcinogenic risk

National University of
Malaysia

• Acceptable Non-Cancer Hazard Quotient (or
Hazard Index)
– US Superfund NCP codified acceptable HQ of 1
– DOE Malaysia (2009); HQ = 1 ; DOE = CLMCG No 2
– US Clean air Act; HQ =1

28-Jan-14

23
Determination of carcinogenic risk

National University of
Malaysia

• Carcinogenic risk is a function of the chronic daily
intake (CDI – chemical intake) and the slope factor
(SF):
US: RISK = CDI x SF
• Risk is the probability of carcinogenic risks
(fractions); unitless; IELCR = incremental Excess Lifetime Cancer
Risk

• CDI or lifetime average daily dose= daily intake
(CDI, mgkg-1d-1) -- exposure
• SF = carcinogenic slope factor (mgkg-1d -1) -1
28-Jan-14

24
Acceptable cancer risk levels

National University of
Malaysia

• US State RBCA Target Risk Policies: 10-5 to 10-4
for development of risk based soil and
groundwater cleanup standards.
• US Clean Air Act : risk 10-4
• Malaysia (DOE, 2009) : 1/10000 to 1/1,000,000
@ 10-4 to 10-6

28-Jan-14

25
National University of
Malaysia

Summary (1)
RISK OF CHEMICAL OF CONCERN

EXPOSURE TO HUMAN
• Inhalation

TOXICITY OF CHEMICAL
• Carcinogenic

• Non-Carcinogenic

• Ingestion
• Contact

• Use NOAEL

Calculate Risk
for Carcinogenic
28-Jan-14

• Use slope factor

Calculate Risk for
Non-Carcinogenic

26
Summary (2)

28-Jan-14

National University of
Malaysia

27
Conclusions

National University of
Malaysia

- Risk is always present
- Risk can be assessed (calculated)
- Risk can also be managed properly
to avoid any health effect / accidents

28-Jan-14

28
Computer Software

28-Jan-14

National University of
Malaysia

29
National University of
Malaysia

28-Jan-14

30
National University of
Malaysia

Thank you

28-Jan-14

31

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Human health risk assessment

  • 1. National University of Malaysia Human Health Risk Assessment Wan Zuhairi Wan Yaacob (Assoc. Prof, PhD) Faculty of Science and Technology National University of Malaysia 43600 Bangi, Selangor, MALAYSIA. 28-Jan-14 1
  • 2. Risk Assessment National University of Malaysia • Risk Assessment in daily life !! 28-Jan-14 2
  • 3. 2 types of Risk Assessment National University of Malaysia 1. QRA – Quantitative Risk Assessment – Risk = Likelihood x consequences 2. ERA – Environmental Risk Assessment a) Human Health Risk Assessment (HRA) • • • Health related risk Risk = hazard x exposure (i) carcinogenic (ii) non-carcinogenic chemicals Fukushima Daiichi nuclear disaster b) Ecological Risk Assessment (ERA) • • 28-Jan-14 Ecological risk at sites Risk = hazard x exposure 3
  • 4. Quantitative Risk National University of Malaysia • Hazard • Probability RISK in Oil and Gas Industry 28-Jan-14 4
  • 5. Risk Assessment National University of Malaysia • Risk of particular event = probability of that event to occur x consequence of the event • Consequence = damage to people, property, economic activity, public service, etc) • Large earthquake: low probability but high consequence • Acceptable risk – Minimum risk that people can accept – Eg. Driving a Car 28-Jan-14 5
  • 7. National University of Malaysia Risk Assessment & Risk Management? RISK PERCEPTION 28-Jan-14 RISK ASSESSMENT RISK MANAGEMENT 7
  • 8. Risk Assessment (Risk Matrix) National University of Malaysia E = Extreme risk; H = High Risk; M = Medium Risk; L = Low Risk Example: • Risk of travelling by car in Malaysia? • Risk of travelling with an aeroplane nowadays? 28-Jan-14 Example • Risk of volcanic eruption in Malaysia? • Risk of earthquake in Japan? 8
  • 9. Concept of Human Health Risk (1) National University of Malaysia Risk = hazard x exposure 28-Jan-14 9
  • 10. National University of Malaysia Concept of Human Health Risk (2) 3 1 2 RISK : Source ------ Pathways ------ Receptors 28-Jan-14 10
  • 11. Concept of Source – Pathways - Receptors National University of Malaysia SOURCE RECEPTORS RISK     28-Jan-14 PATHWAYS         YES NO NO NO 11
  • 12. National University of Malaysia Human Health Risk Assessment (HRA) 1 28-Jan-14 2 12
  • 13. National University of Malaysia Oil Well Pump 28-Jan-14 13
  • 14. National University of Malaysia Exposure Assessment • Quantify contaminant intake at the point of exposure • Intake = I (Intake) 28-Jan-14 14
  • 15. Exposure Assessment National University of Malaysia The General Equation for chemical intake is:-I = C x CR x EFD • I = intake (mgkg-1d-1) -------------– Mg/kg body weight per day BW x AT • Chemical related variable, C – Chemical concentration; the average concentration contacted over the exposure period (eg, mg/L water or mg/kg soil or PPM) • Variables that describe the exposed population – CR = contact rate; the amount of contaminated medium contacted per unit time or event (eg. Litres/day) – EFD = exposure frequency and duration, describes how often and how long exposure occurs. Often calculated using two terms (EF & ED) – EF = exposure frequency (days/year) – ED = exposure duration (years) – BW = body weight; the average body weight over the exposure period (kg) – 70kg (Adult 70kg ; infant (5 kg) ; children (10kg) 28-Jan-14 15
  • 16. National University of Malaysia Exposure Assessment • 28-Jan-14 I = C x CR x EFD -------------BW x AT Assessment-determined variable – AT = averaging time OR total exposure time; period over which exposure is averaged (days) – (1) For evaluation of carcinogenic effects, AT = life expectancy for population of concern (70 years in US) x 365 days/year – (2) For evaluation of non-carcinogenic effects, AT = ED x 365 days/year 16
  • 17. National University of Malaysia Toxicity values • Animal studies Rats Uncertainty factor(UF) or safety factor (SF) Uncertainty factor(UF) or safety factor (SF) Toxicity value for human Feeding, inhalation testing Cancer slope factor (SF) Reference dose (RfD) 28-Jan-14 17
  • 18. Toxicity values for Carcinogens National University of Malaysia • Use slope factor (y = mx) • There is no threshold because exposure to any level of a carcinogenic chemical poses a probability, however small, of generating carcinogenic response. • The curve passes through the origin 28-Jan-14 18
  • 20. No Observed Adverse Effect Level (NOAEL) 28-Jan-14 National University of Malaysia 20
  • 21. National University of Malaysia RISK CHARACTERIZATION 28-Jan-14 21
  • 22. Determination of non-carcinogenic risk National University of Malaysia • Represented by Hazard Quotient (HQ); the ration of chronic daily intake to RfD: HQ = I / RfD • • • • HQ = hazard index (dimensionless) I = the intake (TDI, mgkg-1d-1) RfD = reference dose (mgkg-1d-1) HQ <1.0 = acceptable risk for all contaminants and routes of exposure • HQ>1.0 = the receptors are exposed to the contaminant 28-Jan-14 22
  • 23. Determination of non-carcinogenic risk National University of Malaysia • Acceptable Non-Cancer Hazard Quotient (or Hazard Index) – US Superfund NCP codified acceptable HQ of 1 – DOE Malaysia (2009); HQ = 1 ; DOE = CLMCG No 2 – US Clean air Act; HQ =1 28-Jan-14 23
  • 24. Determination of carcinogenic risk National University of Malaysia • Carcinogenic risk is a function of the chronic daily intake (CDI – chemical intake) and the slope factor (SF): US: RISK = CDI x SF • Risk is the probability of carcinogenic risks (fractions); unitless; IELCR = incremental Excess Lifetime Cancer Risk • CDI or lifetime average daily dose= daily intake (CDI, mgkg-1d-1) -- exposure • SF = carcinogenic slope factor (mgkg-1d -1) -1 28-Jan-14 24
  • 25. Acceptable cancer risk levels National University of Malaysia • US State RBCA Target Risk Policies: 10-5 to 10-4 for development of risk based soil and groundwater cleanup standards. • US Clean Air Act : risk 10-4 • Malaysia (DOE, 2009) : 1/10000 to 1/1,000,000 @ 10-4 to 10-6 28-Jan-14 25
  • 26. National University of Malaysia Summary (1) RISK OF CHEMICAL OF CONCERN EXPOSURE TO HUMAN • Inhalation TOXICITY OF CHEMICAL • Carcinogenic • Non-Carcinogenic • Ingestion • Contact • Use NOAEL Calculate Risk for Carcinogenic 28-Jan-14 • Use slope factor Calculate Risk for Non-Carcinogenic 26
  • 28. Conclusions National University of Malaysia - Risk is always present - Risk can be assessed (calculated) - Risk can also be managed properly to avoid any health effect / accidents 28-Jan-14 28