CHAPTER 2

RISK CONCEPTS
 Chapter 2

This chapter will focus on the basic concept of

environmental risk and risk assessment as applied to
a chemicals manufacturing, processing, and the
impact of exposure to these chemicals on human
health or the environment.
 INTRODUCTION TO :

Risk Concepts
Risk Assessment
Environmental Law and Regulations
Ethics
 Risk Concepts
Risk = f (Hazard, Exposure)
Risk : Probability for an individual to suffer an
adverse effect from an event.

Hazard : Potential for a substance or situation to

cause harm or adverse effects to environment
and/or humans.

Exposure : Magnitude and length of time an

individual organism is put under a certain
constraint (hazard).
The Risk-Hazard-Exposure-Vulnerability Relationship

EXPOSURE RISK VULNERABILITY

HAZARD

Source:http://www.ga.gov.au/pdf/GA1421.pdf
Example
I. Hazardous substances and risk

Potassium Dichromate is a highly toxic carcinogenic

chemical. It is used in some techniques to analyse
exhaled breath for alcohol content. However for this
purpose it is sealed in a tube, and does not become
airborne when air is drawn over it.

Therefore, although it is a highly hazardous

substance, if it is use as described, it does not present
any risk to the subject.
Source:http://www.agius.com/hew/resource/hazard.htm
 Example

II. Non hazardous substances and risk

Flour would not be considered as a hazardous

substance. However, people exposed over a period of
time to airborne flour dust and/or dust by skin contact
could develop dermatitis, conjunctivitis, rhinitis and
even asthma.

Thus, long exposure to a low hazard agent may

result in a substantial risk and low exposure to a
highly hazardous agent may result in a low risk.

Source:http://www.agius.com/hew/resource/hazard.htm
 Exposure Pathways Include :
Occupational Exposure (occurs in the workplace)

Consumer Exposure (to products)

Environmental Exposure
Direct (exposure to air, soil and water)
Indirect (i.e. contamination through the food
chain)
 Indirect Exposure Pathways

Indirect Environmental Exposure

Source:http://www.chem.unep.ch/irptc/Publications/riskasse/A2A4Txtab.PDF
 Types of Risk
Voluntary Risks Involuntary Risks Natural
A consequence of A consequence of Disasters
actions taken out uncontrollable
These include
of necessity or by actions performed
floods, hurricanes,
choice. (e.g., by others. (ex.
earthquakes and
driving a car, riding exposure to
other disasters that
a motorcycle, environmental
are beyond human
smoking cigarettes) contaminants) control.

Source:http://risk.lsd.ornl.gov/minicourse/rap_q1.shtml
 Risk Assessment
Risk assessment should estimate adverse impacts
to health or the environment and determine whether
these impacts pose a serious threat. National
Research Council (USA).

Goal: To understand, quantify and communicate risk

issues as comprehe nsively as possible.

Tools: Laws and regulations concerning the

substances
 Risk Assessment Steps
Hazard Assessment
(Identification)

Dose-Response Exposure
Assessment Assessment

Risk Characterization

*Risk
*Normaly not included in
Management risk assessment.

Source : Environmental Engineering and Science, Allen and Shonnard, pp.123

 Hazard Assessment
Determining the potential and/or known adverse
effects of a given material

Adverse health effects Hazard estimation :

related to chemical Structure Activity
exposure: Relationships (SAR)
Cancer Based on chemical-
Endocrine disruptions specific laboratories
Reproductive toxicity From reference
databases
 Toxicological Hazards
Substances that pose toxicological hazards
can be divided into four categories:

Hazard Classification of Substances

SPECIAL Carcinogenic; Mutagenic; Toxic to Reproduction.

Respiratory Sensitisers.

HIGH Very toxic; Toxic; Skin Sensitisers; Corrosive.

MEDIUM Harmful

LOW Substances examined but not meeting the criteria

of the other hazard categories.
 Carcinogenic Assessments
Genotoxic vs. Non-Genotoxic Carcinogens
A Genotoxic Carcinogen always causes cancer
regardless of its quantity or concentration one
molecule could alter DNA and cause a mutation.

A Non-Genotoxic Carcinogen has a safe

threshold quantity.

If the nature (genotoxicity) of the substance is

unknown, the carcinogen is assumed to be
genotoxic.
Carcinogenic Substances Classification
Group A : Carcinogenic to Humans
Group B1 : Probably Carcinogenic to Humans based on
limited human evidence of carcinogenocity
Group B2 : Probably Carcinogenic to Humans based on
sufficient animal evidence, but inadequate human
evidence
Group C : Possibly Carcinogenic to Humans
Group D : Not classifiable for Human Carcinogenicity
Group E : Evidence of Non-Carcinogenicity for Humans
Example of a Carcinogenic Chemical
Mercury (Hg) is an example of an air toxic

Acute (short-term) exposure to high levels of mercury in

humans results in central nervous system (CNS) damages
which can result in, among others, tremors and mood
changes.

Chronic (long-term) exposure to high levels of mercury in

humans also affects the CNS, with effects such as erethism
(increase excitability), irritability, excessive shyness, and
tremors.

Source: www.osha.gov
Non-Carcinogenic (Toxic) Effects
Assumed to have a dose or exposure threshold
Measurements :

Rf D (Reference Dose) [=] mg pollutant/kg

body weight/day

Rf C (Reference Concentration) [=] mg/m3

Derived from NOAEL (Non Observed Adverse Effect

Level) and LOAEL (Lowest Observed Adverse Effect
Level) using some uncertainty factors
 Non-Carcinogenic Effects
How to Calculate...
Rf D = NOAEL
FA FH FS FL FD
Where:
FA is an adjustment factor to extrapolate from animal to human
populations.
FH is an adjustment factor for differences in human
susceptability.
FS is an adjustment factor used when data are obtained from
subchronic studies.
FL is an adjustment factor applied when the LOAEL is used
instead of the NOAEL.
FD is an adjustment factor applied when the data set is dubious
or incomplete.
 Example : Reference Dose Calculation
For 4-Clorophenol, 2.58 mg/kg-day is considered a
LOAEL, and 1.28 mg/kg-day is considered a NOAEL.
In rats, liver effects were assessed by the determination
of liver weights.
1. Using the NOAEL
NOAEL 1.28 mg/kg-day
Rf D = = = 0.00128 mg/kg-day
FA FH FS 10 x 10 x 10

2. Using the LOAEL

LOAEL 2.58 mg/kg-day
Rf D = = = 0.000258 mg/kg-day
FA FH FS FL 10 x 10 x 10 x 10

Source: http://www.atsdr.cdc.gov/toxprofiles/tp107-a.pdf
Hazard Assessment: Canadian References

WHMIS (Workplace Hazardous Materials Information System)

http://www.hc-sc.gc.ca/hecs-sesc/whmis/index.htm

CanOSH (Canadas National Occupational Health and Safety)

http://www.canoshweb.org/en

CCOHS (Canadian Centre for Occupational Health and Safety )

http://www.ccohs.ca

MSDS (Material Safety Data Sheets)

http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss
Hazard Assessment: American References

NIOSH (National Institute for Occupational Safety and Health)

http://www.cdc.gov/niosh/homepage.html
ATSDR (American for Toxic Substances and Diesease Registery)
http://www.atsdr.cdc.gov

IRIS (Integrated Risk Information System)

http://www.epa.gov/ngispgm3/iris/index.html

National Library of Medicine

Hazardous Substances Data Bank
http://chem.sis.nlm.nih.gov/hsdb/
Toxnet
http://sis.nlm.nih.gov/sis1/
Hazard Assessment: Mexican References

Information about Health and Safety Laws

http://www.salud.gob.mx/unidades/dgaj/
http://www.salud.gob.mx

Information about environmental laws and regulations

http://www.semarnat.gob.mx/wps/portal
Dose-Response Assessments

Characterizing the relationship between

the quantities (dose) and resulting adverse
effects (response) of a given material.

Requires dose-response curves that

demonstrate the effects of chronic toxicity
Dose - Response Curves
X-axis plots the
concentration
Y-axis plots the
response
dose-response
curves typically
follow this shape
 Exposure Assessments
Determining not only the size and nature of the
population affected by a potential exposure but also the
length of time during which they may be exposed.

Normally the exposure assessed will be an

external exposure.

Where the conclusion is that this level is "of

concern", it may be necessary to determine
the internal exposure.
 Risk Characterization
Estimating the magnitude of the adverse effects on
given populations by compiling all the data from the
three previous steps.

This stage involves the quantitation of the

risk following consideration of the
exposure and the dose-response (effect)
relationships.
The
. function of the system is to regulate a wide range of biological
processes, including:

Control of Blood Sugar.

Growth and Function of Reproductive Systems.
Regulation of Metabolism.
Brain and Nervous System Development.

Disruptions in hormonal balance at critical life stages may have

long-lasting effects.

Source:http://www.epa.gov/ORD/NRMRL/EDC/
 Risk Management
Identifying, evaluating, selecting and implementing
actions to reduce risk to populations and environments.

This step is a scientific attempt to identify and estimate the

true risks, by considering the :

Hazard(s)
Dose-Response Relationship
Risk Characterization.

Potential solutions are then proposed, selected and

implemented in order to minimize the risks.
Environmental Law and Regulations

Why are these laws made?

- To protect human health as well as the

environment by placing limits on the concentration
and quantity of different chemicals in manufacturing
waste streams.

- Recently, laws and regulations encouraging

pollution prevention have been put in place to
encourage waste minimization instead of controlling
the regulated substances.
Environmental Law and Regulations
Where can we find them?
North American Commission for Environmental Cooperation
http://www.cec.org/home/index.cfm?varlan=english

Mxico Semarnat
http://www.semarnat.gob.mx/wps/portal
Canada Canadian Environmental Protection Act
http://laws.justice.gc.ca/en/C-15.31/
General Index to Laws
http://laws.justice.gc.ca/en/index.html
USA General Index to Laws
http://www.epa.gov/epahome/rules.html
 Engineering Ethics
In addition to the laws and regulations by which chemical
engineers should abide, there exist codes of ethics.
These codes of ethics can be found :
American Institute of Chemical Engineers (AIChE)
http://www.aiche.org/about/ethicscode.htm
Canadian Society for Chemical Engineers (CSChE)
http://www.chemeng.ca/ethics

Instituto Mexicano de Ingenieros Quimico (IMIQ)

http://www.imiq.org/
The Online Ethics Center for Engineereing and Science
http://www.onlineethics.org/