Bab

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Risk to Safety, Health and Environment:
Perception, Assessment and
Management

Disusun oleh Tim Dosen K3L FTUI

Gasal 2015/2016
Is it a risky place to work ?
Outline of talk

• Introduction
• Risk perception
• Risk assessment
• Risk analysis and management
• Fault tree analysis
• Event tree analysis
• Environmental Risk Assessment
• Problems

Reference :
Charles A. Wentz, Safety, Health and Environmental Protection, MGH, 1998.

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 Introduction

• There is some risk in every decision or

action. This risk is present in all industrial,
government, public, and personal
situations.

• In order to appraise risk and safety,

quantitative methods are preferred
because they are more disciplined and
objective than purely subjective
conclusions.

• Even quantitative methods often involve

some degree of subjectivity that introduce
uncertainty.

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 Risk perception

• The perception of risk depends a great deal on our

personal situation. We take numerous risks daily
with little, if any concern. Yet we become highly
concerned about other less serious risks because
of our personal perception of an activity, chemical
substance, or process operation.
• Everyone would like to live in a risk free
environment, but is this really an attainable goal?
• What about the risk of :
• Drinking a glass of tap water
• Having a chest x-ray for cancer detection
• Cosmic radiation hazards during an air trip
• The chemicals in the soap or shampoo

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 Risk perception (cont)

• The public perception of risk is

often different from the risk
perception of industry and
statisticians.

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Risk perception (cont)

• The identification of the precise risk or risks causes for health-related

problems is a complex problem because the severity and length of exposure
to a wide variety of risks during a lifetime.
• The incidence rate is commonly used to measure and compare industrial
occupational injuries and illnesses

The incidence rate =

(total injuries and illnesses * 200.000) or (total lost workdays * 200.000)

total hours worked by all employees during period

The 200.000 constant is based on 100 full-time equivalent workers

working 40 hours a week, 50 weeks a year.

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 Risk perception (cont)

• Factors affecting the acceptability of risk based on the

perception of people

Greater acceptability Lower acceptability

Voluntary Involuntary
Natural Synthetic
Controllable Uncontrollable
Delayed effect Immediate effect
Essential Nonessential
Major benefits Minor benefits
Experienced Inexperienced
Understandable Not understandable
Known Unknown
Common Uncommon
Routine Special
Low media coverage High media coverage
Low controversy Controversial
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 Risk perception (cont)

• The basis for negative risk perception by communities for

industrial facilities
The basis for negative risk perception
Risks are unfamiliar
Involuntary risks
Risks are controlled by outsiders
Undetectable risks
Risks are unfair
Individual protective action are not permitted
Dramatic and memorable risks
Uncertain risks
Unrelated hazards comparisons
Risk estimation, not reduction, emphasized
Routine
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Risk assessment

Since no activity or technology can be absolutely safe, the

question arises,

“ How safe is safe enough ?”

A safety risk is defined as possible consequences for human
death, disease, injury and for property destruction or damage to
the environment.
Risk equals the probability of the occurrence times the severity of
the harmful effects

Risk = Probability * Consequences

 Risk assessment (cont)

Interdependent steps in determining an acceptable risk

Specify the objectives and measures of effectiveness to be achieved
Define the possible alternatives that could achieve the objectives ands their associated risks
Identify all possible consequences of each alternative
Quantify the various consequences, using consistent assumptions
Analyse the results and prioritise the alternative
Select and implement the best choise for an acceptable risk
Obtain feedback and iterate the process as neccesary

The process of risk assessments

Identification of the potentially harmful hazard

Measurements to estimate the consequences of the hazards
Estimation of the probability of the occurrence of each hazard consequence
Quantitative calculation of risks and comparison with potentially acceptable hazard levels
Characterisation of the hazard risks to be managed, along with the assumptions and uncertainties
Ranking of the risk hazards for management decision making
Risk assessment (cont)

Potential risk factors in the impact of hazards on people, facilities, and community
Type and length of hazard exposure
Number of people exposed inside and outside the facility
Demographics of the exposed people
Effectiveness of emergency response inside and outside the facility
Lost time of employee and outside people
Reduction in employee morale
Damage to public image
Property damage inside and outside the facility
Cost of cleanup, repairs, and lost production inside and outside the facility
Personal injury and damage lawsuits
Backlash legislation and additional regulatory constraints

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 Risk analysis and management
• Effective risk management ensures an objective, consistent response to the identified risks. This
requires through planning, organizing, implementing, and controlling to achieve a successful risk
management program.

Elements of a risk management program

Hazard identification
Risk assessment
Administrative controls
Engineering controls
Emergency response planning
Operation and emergency training
Accident and incident investigation
Near-miss review
Internal and external audit
Feedback and iteration
 Fault tree analysis

• Methodologies to determine and evaluate

process safety hazards:
• What-if checklist
• Hazard and operability study (HAZOP)
• Failure mode and effects analysis (FMEA)
• Fault tree analysis
• An appropriate equivalent methodology

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Fault tree analysis (cont)

• The examination of a process, operation, and facility for potential hazards is a complex
task. Generally it is best to begin with process flow diagrams and an outline of the facility
lay-out.
• A more detailed piping and instrument diagram (P&ID) better identifies all of the potential
hazards.
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 Fault tree analysis (cont)

• Typical fault tree analysis.

• This includes the following steps :

• Define the top event
• Define the intermediate events
• Identify all gates and basic events
• Resolve all duplication & conflict.

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Fault tree analysis (cont)

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• Fault tree analysis for the fluid flow example
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Event tree analysis

• Event tree analysis (ETA) is an inductive logic model that

identifies possible outcomes from given initiating event.
An initiating event will usually initiate an accident or
incident. An ETA considers the responses of operators and
safety systems to the initiating event. This technique is
best suited for analyzing complex process involving several
layers of safety systems and emergency procedures
 Event tree analysis (cont)

• The first step is to define an

initiating event that could lead to
failure of the system: equipment
failure, human error, utility
failure, or natural disaster.
• The next steps is to identify
intermediate actions to eliminate
or reduce the effects of the
initiating event. The event tree
develops two branches for each
intermediate event, one for a
successful and the other for an
unsuccessful operation.
• The top path represents success
and the bottom path failure.
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Event tree analysis (cont)

• The probability of any

branch of the event tree
occurring is the product
of the event
probabilities on the
branch.

Fault tree analysis

for the fluid flow
example
 Event tree analysis (cont)

• The event tree can be

summarized as follows:
• Identify initiating events that
• could result in an accident
• Identify the safety functions to
• mitigate the initiating event
• Construct the event tree
• Describe accident sequence
• outcomes and their
probability.

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Environmental Risk Assessment

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What is environmental risk
assessment (ERA)?

• Qualitative and quantitative valuation

of environmental status

• ERA is comprised of:

1. human health risk assessment;
2. ecological risk assessment.
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 Systematic approach to risk
assessment

• ERA should be conducted when it is

determined that a management action may
have consequences to either humans or the
environment.

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 ERA addresses three questions

1. What can go wrong with the project?

2. What is the range of magnitude of these
adverse consequences?
3. What can be done and at what cost to reduce
unacceptable risk and damage?
The interactive
nature of ERA
Purposes in performing ERA

• to learn about the risks

• to reduce the risk
 Risk comparison

• Probability of frequency of events causing one

or more immediate fatalities.
• Chance of death for an individual within a
specified population in each year.
• Number of deaths from lifetime exposure.
• Loss of life expectancy considers the age at
which death occurs.
• Deaths per tone of product, or per facility.
Case Study
Environmental Risk Assessment
(Ref. BIG MAP, Iowa State University)

The release of a Genetically Engineered

plant
to the environment requires
consideration of the environmental
safety of the GE plant
within the context of the scale,
nature, and region of deployment.

Environmental Risk Assessment (ERA)

is the process which evaluates risk as
the
likelihood for an undesired
ERA considers the impact of introduction of a
GE plant into a given environment.
Specific questions that are commonly addressed in
the ERA for most GE plants:

• Does the modification of the plant cause it to have attributes

commonly associated with weeds in managed environments?
Invasiveness in natural environments?

• Will the transgenic element in the GE plant move into native plant
populations? And so what if it does?

• Will the GE plant adversely impact non-target organisms that may

be of special interest because they are
beneficial, endangered, threatened, or charismatic?
Principles of ERA
The well-established principles of ERA are
applied to the potential environmental risks
of biotechnology through a process that

• Defines the regulatory need (problem context)

• Describes relevant concerns for analysis (problem
definition);
• Estimates the likelihood of exposure (exposure
characterization);
• Evaluates the consequence of exposure (effects
characterization); and
• Formulates an understanding of degree of risk
(risk characterization).

http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?did=12460
 Risk—Likelihood of an unwanted
outcome

• Risk is the likelihood that there will be an undesired

consequence when the GE plant is present in the environment.
• Fully quantitative ERA describes risk as a probability of exposure
to the GE plant and the undesired consequence of the exposure.
• A probability ranging from zero to one
• More frequently risk is described as a likelihood or degree of
concern based on a comparison of the GE plant and its uses to
similar non GE plants and their uses.
• There are high, low, or negligible concerns regarding
the GE plant and its proposed use
There is always some degree of
risk
Risk of anything is zero only in the
absolute absence of exposure

Thus for the GE plant risk is comparative –

it asks

Is the GE plant and the way it will be

used riskier than the comparable
non-GE plant and its uses with
which we are familiar?
ERA focuses on change
The undesired consequence we evaluate in
the ERA
is focused on a specific change that has been
brought about with genetic transformation
This change may be do to
• A stressor
• the changed attribute of the GE plant
• for instance, an expressed protein
• Or an action
• environmental release of the transgenic
plant
• for instance, release of a GE plant into a
particular environment
ERA is a tiered process
The ERA ideally proceeds in tiers of
increasing complexity
– lower tiers focus on stressor-mediated
effects
in laboratory and glasshouse settings
with
well-controlled conditions
– higher tiers focus on action-mediated
effects
in semi-field and field environments
which
are more realistic but less well-
controlled.
Problem Formulation
Problem formulation is a formal process
whereby relevant considerations for risk
assessment are determined.

Problem Formulation considers –

• Problem context – establishes the
parameters
for the risk assessment, including policy
goals, scope, assessment endpoints and
methodology.

• Problem definition – distills risk questions

into tractable problems for analysis
Comparability
The problem formulation develops the plan
for the
ERA by first developing a baseline of
comparability
• To what degree are the host crop and the
expressed attribute familiar?
• Is the GE plant substantially equivalent to
the non-GE plant in it composition and
intended use?
• If yes, the ERA can proceed with a focus on
the changed attribute of the GE plant
Are the GE and non-GE crops the
same?
The problem formulation should establish that the
particular
GE plant is substantially equivalent to the
comparable
non-GE plant as it is encountered and used in
present-day agriculture
Data (found in the literature and/or generated and
submitted by the product developer) provides the
basis for the determination of substantial
equivalence.

In most regulatory schemes, precursor information

has already been considered in the regulatory
dossier; the ERA is found as an annex to the
dossier that considers ecological safety only once
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_117862077574
the substantial
7.htmequivalence has been

demonstrated. A good example of this process can

Precursor information for use in
Problem Formulation

Precursor information establishes that other than of an

changes the GE plant is equivalent to non-GE comparators.
Once equivalence is established on the basis of the GE plant
characterization, the ERA is conducted with emphasis on the
change.
For instance, in the problem formulation for a non target
insect ERA, precursor information describes
• the characteristics of the donor and recipient organisms;
• the genes inserted and their expression;
• agronomic performance and characteristics;
• equivalence of the plant expressed protein to the wild
counterpart;
• compositional characteristics (nutrients and antinutrients).
This information is found in published studies and data
submitted
from product developers and is integrated with expert opinion
and stakeholder deliberations to determine the risk
hypothesis to be tested, the endpoints for consideration, and
the scope of the analysis plan.
An example of using precursor information
to focus the ERA

Cry1 Bt toxin expressed in corn for which an ERA is needed for

approval of an unconfined environmental release.

The problem considers the degree to which the host crop (corn) and the
expressed product (a Cry1 protein) and their combination are familiar
(well-understood) in terms of
• history of use;
• scientific knowledge;
• prior regulatory considerations; and
• unique aspects of the environmental release that is being considered.
In this case,
• Corn biology, production, and use are well-understood
• The GE corn will not alter corn biology, production, and use
• The change involved is to produce Cry1 proteins which are selectively
active on Lepidoptera,
• The specific selectivity of theCry1 protein can be established from
literature and/or developer data
• The history of use of Cry1 proteins in other GE plants and sprayable
biopesticides is well-understood
• There is 10+ years of experience in the environmental release of Cry1 Bt
corn throughout various regions of the world
Risk hypothesis
• The risk hypothesis represents an assumption
regarding the cause-effect relationships between
sources, changes, exposure routes, endpoints,
responses and measures relevant to the ERA.

• A tentative explanation taken to be true for the

purpose of argument or investigation

• Not to be confused with scientific hypotheses

which are specific, testable postulates (these are
a part of the analytical phase of the ERA)

• The ERA process for GE plants is comparative,

so the risk hypothesis considers the comparative
difference as it relates to exposure and the
undesired consequences of exposure
The analytical plan
Addresses the specific risk hypothesis
Describes various measures to be used in the
assessment and the characterizations that
form
the body of the risk assessment in terms of

• proscribed studies to be conducted,

• the appropriate tier for analysis,
• the appropriate risk formulation, and
• specific decision criteria that will be
used for risk characterization.
The analysis phase

Has three main parts

• characterization of exposure;

• characterization of effect (a
consequence
of exposure); and

• characterization of risk (an undesired

consequence of exposure given that
exposure occurs).
Effects characterization
The specific adverse effect of interest has been identified in
the problem formulation.

In characterizing effects, the risk assessor seeks information

establishing a specific adverse effect (or lack there of) of
the transformation in the GE plant.

The effects characterization will use data generated at

various tiers (Tiered process example) depending on the
nature of the problem and the uncertainty.
Exposure characterization
Establishes the source, duration, intensity, and
duration of exposure on the basis of expression data
as well as knowledge of the crop, its management, and
the environment where it will
be released.

This phase of analysis can also proceed in tiers

beginning with estimated environmental
concentrations that are modeled from knowledge of
the GE plant and the environment where it will
be deployed, through to higher tiered field
measurements of actual environmental concentrations
Environmental fate is critical to exposure
characterization

Environmental fate describes what happens to the transgene

and its expressed product in the environment.

Two relevant examples are soil degradation and gene flow.

• If soil degradation studies show that residues of the transformed plant are
not likely to persist or accumulate in the soil, then there is negligible
exposure and little reason for concern that soil organisms will be at risk due
to long term exposures (this is the typical case for Cry proteins released to
the environment).
• If gene flow studies show that there is no stable introgression of the
transgene into a receiving population, then there is no route for
environmental exposure due to gene flow and limited concern for long term
effects from this route of exposure.

In both of these cases, exposure is unlikely and therefore risk is negligible.

Risk characterization
In the final stage of the analysis, risk is characterized
from consideration of the effects and exposure
characterizations.

The risk characterization makes a statement, with respect to

the risk hypothesis, regarding the likelihood for an undesired
consequence to be manifested under realistic conditions of
exposure.

The risk conclusion compares the GE plant and its

conditions of environmental release with the non-GE
plant and the
prevailing conditions of its use.

It is common in for GE plant ERA for the result to be a

qualitative lines-of-evidence determination which will express
risk as a likelihood using terms such as high, moderate, low,
or negligible.
Risk conclusion

In the final phase of the ERA, risk conclusions are drawn on the
basis of the specific problem formulation and analysis.
The risk conclusion makes explicit statements regarding what is
known, variable, uncertain, and sensitive in the risk estimate.
The ERA at this point may additionally suggest mitigation
options that can be implemented to
further reduce the degree of risk identified – or
the level of uncertainty in outcomes.
For instance, a common risk mitigation is to implement post-
commercial monitoring to verify the integrity and adequacy of
the risk estimate and to allow for reassessment should concerns
be identified.
ERA is science-based

Risk assessment as a science-based activity

occurring within the overall process of risk
analysis (which also considers risk management
and communication).
Many national and international regulatory standards tend to
intermix risk assessment and risk management under
guidance for risk assessment.
For example, the EFSA guidance for GE risk assessment includes
provision for general surveillance monitoring as a risk
management activity unrelated to the science-based
evaluation of exposure and its consequence.
Ecological considerations
The ERA process is a flexible framework for addressing any nature of concern
that arises from a case-specific instance of GE plant environmental safety
assessment.
The problem formulation phase determines those concerns relevant to
environmental safety and distills the concern into a risk hypothesis that
can be characterized. The process therefore is highly flexible.
Experience with GE plants that have been assessed and commercialized to
date identifies certain base ecological considerations that need be explicitly
considered in undertaking the ERA, especially with respect to common
regulatory concerns. These are gene flow, weediness, and adverse effects to
non-target organisms. Each of these are described in the remaining
presentation with examples of how they have been addressed through ERA.