Provenue Corporation Sdn. Bhd.

Risk Characterization in Health

Risk Assessment
Jamal Hisham Hashim, PhD, MCIEH
Director, Provenue Corporation Sdn. Bhd.
Visiting Professor, UN University-
International Institute for Global Health

Short Course on Health Risk and Impact Assessment in Environmental Impact

Assessment (EIA), Universiti Putra Malaysia, 26-28 September 2018
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 Steps in Health Risk Assessment
According to the National Academy of Sciences :
• Hazard identification : characterization of innate adverse toxic
effects of agents.
• Dose-response assessment : characterization of the relation
between doses and incidences of adverse effects in exposed
populations.
• Exposure assessment : measurement or estimation of the
intensity, frequency, and duration of human exposures to
agents.
• Risk characterization : estimation of the incidence of health
effects under the various conditions of exposure.

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 Calculation of Safe Air and
Water Concentration

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 Calculating Safe Air Concentration
Cair = RfDi x 70 kg
  (BR t)
• Where,
• Cair (or RfC) is the safe air concentration in mg/m3.
• RfDi is the inhalation reference absorbed dose in mg/kg/day.
•  is the lung absorption fraction (taken as 1 if unknown).
• BR is the breathing rate in m3/hr : environmental exposure =
0.83 m3/hr or 20 m3/day; occupational exposure = 2 hours of
heavy breathing at 1.47 m3/hour and 6 hour of moderate
breathing at 0.98 m3/hour = 8.82 m3/day.
• t is the exposure duration in day or hours
(24 hours for environmental exposure and 8
4
hours for occupational exposure).
Calculating Safe Water Concentration

Cwater = RfD x 70 kg
2 liter/day

Where,
• Cwater is the safe water concentration in mg/l.
• RfD is the reference absorbed dose.

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 Qualitative Risk Assessment
It merely characterizes or compares the
hazard of a chemical relative to others, or
defines the hazard in only qualitative terms,
such as mutagen or carcinogen, which
connote certain risks or safety procedures,
and as such may not necessarily require a
numerical assessment of risk.

Source : James, R.C. 1985. Risk assessment. In : Williams, P.L. and

Burson, J.L. Industrial Toxicology. New York : Van Nostrand Reinhold.
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 A Qualitative Risk Assessment Matrix

Source : Clemens P.L. and Simmons R.J. 1998. System safety and risk management : A guide for engineering educators. Cincinnati :
7 National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services.
 • Code 1 : Imperative to suppress risk to a lower level.
• Code 2 : Operation requires written, time-limited waiver, endorsed by management.
• Code 3 : Operation permissible.
• Personnel must not be exposed to hazards in Risk Zones 1 and 2.

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 Health Impact Significance Rating

Source : International Council on Mining and Metals (ICMM) (2010). London: ICMM

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 Malaysian Environmental Health Risk Matrix

Risk rating = Ʃ (hazard rating) × Ʃ (exposure rating)

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 Unregulated Pig Farming in Melaka

Untreated leachate from 32 pig farms in

Paya Mengkuang, Melaka discharges in
drains which enters Sg. Tuang which finally
flows into the sea at Pengkalan Balak Beach.
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 Malaysian Hazard Risk Probability and Severity
Probability Level Definition
Frequent/Almost
certain 5 Likely to occur frequently (more than once a year).
Will occur several times in the lifespan of a hazard source (once in
Probable/Likely 4 1 to 3 years).
Likely to occur sometime in the lifespan of a hazard source (once
Occasional/Possible 3 in 3 to 5 years).

Remote/Unlikely 2 Unlikely, but possible to occur (once in 5 to 10 years).

So unlikely, it can be assumed that occurrence may not be

Improbable/Rare 1 experienced (once in more than 10 years).

Severity Category Definition

Several fatalities, life-threatening disability or injury, with major
Catastrophic V impact for a large population.
Few fatalities, permanent disability or injury with hospitalisation,
Major IV with major impact for a small population.
No fatality, permanent disability but non-permanent injury with
Moderate III hospitalisation, with a minor impact for large population.
No fatality, non-permanent injury or disability with possible
Minor II hospitalisation, with a minor impact for small population.
No fatality, no injury or disability requiring hospitalisation, with an
Insignificant I insignificant impact on a population.
Note : Adopted from the risk assessment matrices of MIL STD 882B (1993)1, WHO/FAO (2009)2, and
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Department of Health, Government of Western Australia (2010) 3.
 Malaysian Hazard Rating Score
V IV III II I
Probability/Severity Catastrophic Major Moderate Minor Insignificant

5 Almost certain 10 9 8 7 6

4 Likely 9 8 7 6 5

3 Possible 8 7 6 5 4

2 Unlikely 7 6 5 4 3

1 Rare 6 5 4 3 2

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 Malaysian Exposure Rating Score
Level 4 3 2 1
Population profile/ Residential Hospital/ School Recreational
Population density Educational
institution
5 >1,501 persons per km2 9 8 7 6
4 1,001-1,500 persons per km2 8 7 6 5

3 501-1,000 persons per km2 7 6 5 4

2 101-500 persons per km2 6 5 4 3
1 <100 persons per km2 5 4 3 2
0 No population 0 0 0 1

Note : For a sub-district with no population living there, an exposure rating score
of 1 is given as there is possibility of outsiders coming to the sub-district for
recreational purposes.
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 Malaysian Risk Rating Score

Risk rating = Ʃ (hazard rating) × Ʃ (exposure rating)

Acceptable risk = Risk rating of < 2,000
Unacceptable risk = Risk rating of 2,000 and above

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 Quantitative Risk Assessment

It generates a numerical
measure of the risk or safety of
a chemical exposure.
Source : James, R.C. 1985. Risk assessment. In : Williams, P.L. and
Burson, J.L. Industrial Toxicology. New York : Van Nostrand Reinhold.

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 Probability of Lethality Using
Probit Dose-Response
Equation

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 The Bhopal Disaster
• The Bhopal Disaster is the world’s worst industrial disaster.
• It occurred on the night of 2nd December 1984 at the Union
Carbide India Limited pesticide plant in Bhopal, Madhya
Pradesh, India.
• Over 500,000 people were exposed to methyl isocyanade
gas and other chemicals.
• 3,787 people were believed to have died.

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 Lethality probit dose-response equations for specific chemicals
Table 6.4: Probit constants*
Material a b n
Acrolein -9.93 2.05 1.0
Acrylonitrile -7.81 1.0 1.3
Allyl Alcohol -4.22 1.0 1.0
Ammonia -16.14 1.0 2.0
Azinphosmethyl -1.94 1.0 1.0
Benzene -109.78 5.3 2.0
Bromine -10.50 1.0 2.0
Carbon Disulfide -46.56 4.2 1.0
Carbon Monoxide -7.25 1.0 1.0
Carbon Tetrachloride -6.29 0.41 2.5
Chlorine -13.22 1.0 2.3
Ethylene Oxide -6.19 1.0 1.0
Hydrogen Chloride -6.28 1.0 1.0
Hydrogen Cyanide -9.68 1.0 2.4
Hydrogen Sulfide -11.15 1.0 1.9
Methyl Bromide -5.92 1.0 1.0
Methyl Isocyanate -0.34 1.0 0.7
Nitrogen Dioxide -17.95 1.0 3.7
Parathion -2.84 1.0 1.0
Phosgene -27.2 5.1 1.0
Phosphamidon -3.14 1.0 0.7
Phosphine -2.25 1.0 1.0
Propylene Oxide -7.42 0.51 2.0
Sulfur Dioxide -18.22 1.0 2.40
Tetraethyl Lead -1.5 1.0 1.0
Toluene -6.79 0.41 2.50
*Pr = a + b ln V
V = Cnt ; causative variable
C = concentration (ppm)
t = time (min)
Source: Prugh, R.W., “Quantitative Evaluation of Inhalation Toxicity Hazards,” Proceedings of the 29th
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Loss Prevention Symposium, American Institute of Chemical Engineers (July 31, 1995)
 Probit equation : Pr = a + b ln (Cn t)
If C = 1500 ppm; t = 480 min, compare the
relative toxicities of benzene and toluene

Benzene : Pr = a + b ln (Cn t)
= -109.78 + 5.3 ln (15002 x 480)
= 0.46 =  1% lethality
Toluene : Pr = a + b ln (Cn t)
= -6.79 + 0.41 ln (15002.5 x 480)
= 3.24 = 3 - 4 % lethality

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 Probit equation : Pr = a + b ln (Cn t)
What would be the concentration of methyl
isocyanide that would kill 50% of those
exposed to the concentration in 30 minutes?

Pr = a + b ln (Cn t)
5.0 = - 0.34 + 1 ln (C 0.7 x 30) NIOSH :
ln (C 0.7 x 30) = 5.0 + 0.34 / 1 = 5.34 2-hr LC50 (rats)
= 21 ppm
C 0.7 x 30 = 208.5 IDLH = 3 ppm

C 0.7 = 208.5 / 30 = 6.95

0.7 √(6.95)

C = 16 ppm
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 Table 6.2: Transformation of probit to percent affected.
% 0 1 2 3 4 5 6 7 8 9
0 - 2.67 2.95 3.12 3.25 3.36 3.45 3.52 3.59 3.66
10 3.72 3.77 3.82 3.87 3.92 3.96 4.01 4.05 4.08 4.12
20 4.16 4.19 4.23 4.26 4.29 4.33 4.36 4.39 4.42 4.45
30 4.48 4.50 4.53 4.56 4.59 4.61 4.64 4.67 4.69 4.72
40 4.75 4.77 4.80 4.82 4.85 4.87 4.90 4.92 4.95 4.97
50 5.00 5.03 5.05 5.08 5.10 5.13 5.15 5.18 5.20 5.23
60 5.25 5.28 5.31 5.33 5.36 5.39 5.41 5.44 5.47 5.50
70 5.52 5.55 5.58 5.61 5.64 5.67 5.71 5.74 5.77 5.81
80 5.84 5.88 5.92 5.95 5.99 6.04 6.08 6.13 6.18 6.23
90 6.28 6.34 6.41 6.48 6.55 6.64 6.75 6.88 7.05 7.33
% 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9
99 7.33 7.37 7.41 7.46 7.51 7.58 7.65 7.75 7.88 8.09

Source: Finney, DJ, Probit Analysis, 3rd Ed. (London: Cambridge University Press, 1971), p.23.

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 Determination of Hazard
Quotient (HQ) and Lifetime
cancer Risk (LCR)

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 A multi-source, multi-media, multi-exposure pathway

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 COPC = Compounds of potential concern

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 Acceptability of Risk
• As events or activities in life are never risk-free,
society must identify a level of risk they consider as
acceptable or tolerable.
• Government agencies and the courts sometimes
refer to this acceptable risk as reasonable risk.
• Acceptable risk is a societal acceptance of a level of
risk, which those who are being subjected to the risk,
consider as tolerable or as something they can live
with comfortably.
• Thus, acceptable risk may vary from society to
society or from community to community.
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 Acceptability of Cancer Risk
• The one in a million or 10-6 acceptable risk level
for a potentially fatal event such as cancer is a
societal guideline rather than a norm.
• The Food and Drug Administration (FDA) in the
U.S. first proposed the regulation of carcinogenic
drugs used in food producing animals in 1973 with
an acceptable lifetime risk level of 10-8.
• Later, this acceptable risk level was revised to10-6.
• This minimal risk level came to be known as de
minimis risk, whereby the risk is so small that it is
beyond concern.

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 Acceptability of Cancer Risk

• Levels of 10-6 to 10-4 are given as a range

of "generally acceptable risk (Kelly, 1991).
• Level or risk below 10-6 are termed as
“clearly acceptable.”
• Level of risk greater than 10-4 are termed
as “clearly unacceptable.”

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 Malaysia’s acceptable risk
• Malaysia’s definition of acceptable risk :
 For non-carcinogenic effect, as a hazard
quotient (HQ) of less than 1.
 For carcinogenic effect, a lifetime cancer risk
(LCR) of between 10-6 to 10-4 is acceptable. Risk
> 10-4 is clearly unacceptable, while risk < 10-6
is clearly acceptable.
• Risk acceptability is a public concept and
demands that the public be informed of the
level of risk involved.

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 COPC Intake from Soil
Isoil = Csoil x CRsoil x Fsoil
BW
Where, Isoil = Daily intake of COPC from soil (mg/kg-day)
Csoil = COPC concentration in soil (mg/kg)
CRsoil = Rate of soil consumption (kg/day)
(0.0002 for child, 0.0001 for adult)
Fsoil = Fraction of soil that is contaminated = 1 (unitless)
BW = Body weight (kg)
(15 for child, 70 for adult)
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 COPC Intake from Drinking Water
Idw = Cdw x CRdw x Fdw
BW
Where, Idw = Daily intake of COPC from drinking water (mg/kg-day)
Cdw = COPC concentration in water (mg/L)
CRdw = Rate of water consumption (L/day)
(0.67 for child, 1.7 for adult)
Fdw = Fraction of water that is contaminated = 1 (unitless)
BW = Body weight (kg)
(15 for child, 70 for adult)
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 COPC Intake from Fish

Ifish = Cfish x CRfish x Ffish

Where, Ifish = Daily intake of COPC from fish (mg/kg-day)

Cfish = COPC concentration in fish (mg/kg)
CRfish = Consumption rate of fish (kg/kg-day)
(0.00088 for child, 0.00125 for adult)
Ffish = Fraction of fish that is contaminated = 1 (unitless)

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Hazard Quotient from Ingestion Exposure
IT = Isoil + Idw + Ifish
HQ = IT x ED x EF
RfD x AT x 365 days/yr
Where, IT = Total daily intake of COPC from all sources
(mg/kg-day)
ED = Exposure duration (years)
(6 years for child, 30-40 years for adult)
EF = Exposure frequency = 350 days/year
RfD = Oral reference dose (mg/kg-day) : from IRIS
AT = Averaging time = ED (years)
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 Cancer Risk from Ingestion Exposure
IT = Isoil + Idw + Ifish
Cancer Risk = IT x ED x EF x CSF
AT x 365 days/yr
Where, IT = Total incremental daily intake of COPC from all
sources (mg/kg-day)
ED = Exposure duration (years)
(6 years for child, 30-40 years for adult)
EF = Exposure frequency = 350 days/year
CSF = Oral cancer slope factor (mg/kg-day-1) from IRIS

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AT = Averaging time = 70 years
 Air Quality Dispersion Modeling Output

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Hazard Quotient from Inhalation Exposure
EC = Ca x EF x ED HQinh = EC x 0.001
AT x 365 days/yr RfC

Where, EC = Exposure concentration (µg/m3)

Ca = COPC air concentration (µg/m3)
EF = Exposure frequency = 350 days/year
ED = Exposure duration (years)
(6 years for child, 30-40 years for adult)
AT = Averaging time = ED (years)
HQinh = Inhalation hazard quotient (unitless)

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RfC = Reference concentration (mg/m3)
 Cancer Risk from Inhalation Exposure
EC = Ca(i) x EF x ED
CRinh = EC x URFinh
AT x 365 days/yr
Where, EC = Exposure concentration (µg/m3)
Ca(i) = Incremental COPC air concentration (µg/m3)
EF = Exposure frequency = 350 days/year
ED = Exposure duration (years)
(6 years for child, 30-40 years for adult)
AT = 70 years (lifetime)
CRinh = Incremental inhalation cancer risk (unitless)
URFinh = Inhalation unit risk factor (mg/m3)-1
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 Proposed Expansion of a Sanitary Landfill Site

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 Operation Phase AIR QUALITY MODELLING RESULT
Predicted Incremental GLC of PM10 (ug/m3) for 24-hr Averaging Time

Scenario 1: Without Control Measures

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 Operation Phase AIR QUALITY MODELLING RESULT
Predicted Incremental GLC of PM10 (ug/m3) for 24-hr Averaging Time

Scenario 2: With Control Measures

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 Operation Phase
AIR QUALITY MODELLING RESULT
Predicted Landfill Emission Ground Level Concentration (GLC) at Sensitive Receptors due to
Project Operation

Landfill Emission
Receptor NMOC H2S C6H6 C7H8
*CH4 (mg/m3)
(µg/m3) (µg/m3) (µg/m3) (µg/m3)
A1 Peak 2.02 Peak 123.3 2.93 0.33 8.7
Annual Average 1.04 24-hour Average 63.8 1.49 0.19 4.5
A2 Peak 2.50 Peak 159.1 3.61 0.40 10.8
Annual Average 1.28 24-hour Average 78.6 1.83 0.24 5.6
A3 Peak 9.08 Peak 550.1 13.06 1.46 39.0
Annual Average 4.66 24-hour Average 284.7 6.64 0.86 20.1
A4 Peak 0.07 Peak 6.5 0.15 0.02 0.5
Annual Average 0.03 24-hour Average 3.4 0.08 0.01 0.2
A5 Peak 0.05 Peak 4.8 0.12 0.01 0.3
Annual Average 0.03 24-hour Average 2.5 0.06 0.01 0.2
A6 Peak 0.21 Peak 16.7 0.40 0.04 1.2
Annual Average 0.11 24-hour Average 8.7 0.20 0.03 0.6
A7 Peak 0.14 Peak 18.4 0.44 0.05 1.3
Annual Average 0.07 24-hour Average 9.5 0.22 0.03 0.7
A8 Peak 0.10 Peak 9.5 0.23 0.03 0.7
Annual Average 0.05 24-hour Average 4.9 0.11 0.01 0.3
A9 Peak 0.04 Peak 3.8 0.09 0.01 0.3
Annual Average 0.02 24-hour Average 2.0 0.05 0.01 0.1
AAAQG Limit 110 44 330

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 Note : ED was taken as 42 years (37 years of landfill operation plus 5 years post-operation.

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 Treated Leachate Final Discharge

Dischange to
Sg Tengah

Final Discharge
Point from LTP

46
 Note : Scenario 2 is project baseline plus expansion with outfall into Sg Tengah. Scenario 3 is project baseline
plus expansion discharging at low flow during low tide with outfall into Sg Tengah.
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Thank you

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