Relevance of Risk
Analysis/Assessment to
International Trade and the
Precautionary Principle
Tom Kasari, DVM, MVSc
Diplomate, American College Veterinary Preventive Medicine
(Epidemiology)
Diplomate, American College Veterinary Internal Medicine
Presented by: Stan Bruntz, DVM MPH
USDA-APHIS-VS
Center for Epidemiology and Animal Health
Fort Collins, Colorado
Agenda
• Review relevance of risk
analysis/assessment to international
trade and the Precautionary Principle
• Review risk analysis process and its
component risk assessment procedure
• Review quantitative versus qualitative
risk assessment methodologies
Relevance of Risk
Analysis/Assessment to
International Trade
• As per WTO (1995) Multilateral Trade
Agreements, the Agreement on the
Application of Sanitary and Phytosanitary
Measures (the “SPS Agreement”) sets out
for member countries the basic rules for
food safety and animal and plant health
requirements
159 out of 196 Countries in the World are WTO Members
As of March 2013
Map source: www.wto.org/english/thewto_e/countries_e/org6_map_e.htm
Relevance of Risk
Analysis/Assessment to International
Trade (WTO SPS Agreement)
• WTO Article 5.1:
“Members shall ensure that their sanitary
or phytosanitary measures are based on
an assessment, as appropriate to the
circumstances, of the risks to human,
animal or plant life or health, taking into
account risk assessment techniques
developed by the relevant international
organizations”
Source: http://www.wto.org/english/thewto_e/coher_e/wto_oie_e.htm
Relevance of Risk
Analysis/Assessment to International
Trade (WTO SPS Agreement)
• WTO Article 5.1:
Relevant international organization for animal
“Members
shall ensure that their sanitary
health:
or phytosanitary measures are based on
Organization
Animal Health
an World
assessment,
as for
appropriate
to the
(aka Office International
des Epizooties
OIE)
circumstances,
of the
risks toorhuman,
animal or plant life or health, taking into
account risk assessment techniques
developed by the relevant international
organizations”
Source: http://www.wto.org/english/thewto_e/coher_e/wto_oie_e.htm
Relevance of Risk
Analysis/Assessment to International
Trade (WTO SPS Agreement)
• WTO SPS Measures Article 5.1 is
basis for using OIE guidelines for
risk analysis (& component risk
assessment) process
– OIE Terrestrial Animal Health Code
(2013)– Vol I: Section 2; Chapter 2.1.
Import Risk Analysis
Relevance of Risk
Analysis/Assessment to International
Trade (WTO SPS Agreement)
• Besides assessment of risk, other key
concepts contained in the SPS
Agreement:
–
–
–
–
–
Harmonization
Equivalence
Regionalization & compartmentalization
Transparency
Notification
Relevance of Risk
Analysis/Assessment to International
Trade (WTO SPS Agreement)
• Governments encouraged to “harmonize”
their animal health standards based on
international standards, guidelines, and
recommendations developed in other
international organizations (i.e. OIE)
Relevance of Risk
Analysis/Assessment to International
Trade (WTO SPS Agreement)
• Governments encouraged to “harmonize”
their animal health standards based on
international standards, guidelines, and
recommendations developed in other
international organizations (i.e. OIE)
• Harmonization means the establishment,
recognition and application of common
sanitary and phytosanitary measures
Relevance of Risk
Analysis/Assessment to International
Trade (WTO SPS Agreement)
• National standards do not violate
the SPS Agreement simply by
differing from international norms
(non-harmonized)
– Requirements can be stricter
– Justify on basis of analysis of scientific
evidence and the risks involved
Equivalence
• Trading partners recognition that
significantly different animal health and
production systems can provide equivalent
animal and human health protection for
the purpose of international trade
– Infrastructure
– Surveillance policies and/or operating
procedures
– Laboratory systems
– Border security
– Internal movement controls
Regionalization (Zoning)
• Region/Zone means a clearly defined
geographical area (country, part of a
country, parts of several countries,
several countries) containing an animal
subpopulation with a distinct health
status with respect to a specific disease
for which required surveillance, control
and biosecurity measures have been
applied for the purpose of international
trade.
Compartmentalization
• Compartment
– means one or more establishments
under a common biosecurity
management system containing an
animal subpopulation with a distinct
health status with respect to a specific
disease or specific diseases for which
required surveillance, control and
biosecurity measures have been applied
for the purpose of international trade.
Definition
• Recognition of animal populations of
different health status
– Zoning/regionalization
• Geographical basis
– Compartmentalization
• Management and biosecurity
Zones and compartments
• Both concepts are similar
• The difference is the responsibility of the
application of biosecurity measures
– Disease-free zones  Official sector
– Compartments  Private sector
• Need for close supervision and
accreditation by the official veterinary
service
Regionalization
State’s swine industry
Interstate Trade
Interstate Trade
Regionalization = establishing and maintaining a disease free status
for a subpopulation of animals based on a geographical basis
Compartmentalization
State’s swine industry
Interstate Trade
Interstate Trade
Compartmentalization = establishing and maintaining a disease free status for
a subpopulation of animals based on management systems related to
management and biosecurity
Relevance of Risk
Analysis/Assessment to International
Trade (WTO SPS Agreement)
• Risk analysis and regionalization or
compartmentalization depend on the data
generated by a soundly designed
comprehensive surveillance system
– Epidemiology is a key element in providing the
scientific basis to satisfy international trade
requirements
Relevance of Risk
Analysis/Assessment to International
Trade (WTO SPS Agreement)
• Risk analysis and regionalization
depend on the data generated by a
soundly designed comprehensive
surveillance system
• “Harmonization”, “equivalence”
“transparency”, and “notification” are
the basis for mutual trust between
veterinary services of trading partners
Relevance of Risk
Analysis/Assessment to International
Trade (WTO SPS Agreement) and
Precautionary Principle
• Precautionary principle: If an action
or policy has a suspected risk of
causing harm to the public or to the
environment, in the absence of
scientific consensus that the action or
policy is harmful, the burden of proof
that it is not harmful falls on those
taking an action.
Relevance of Risk
Analysis/Assessment to International
Trade (WTO SPS Agreement) and
Precautionary Principle
• Precautionary Principle tempered by risk
assessment requirement of WTO trading
partners when it comes to matters of
potential onerous animal health
regulations
“If in doubt, keep it out” zero-risk approach to mitigating
animal health-related trade issues is unacceptable
Relevance of Risk Analysis/Assessment
to International Trade (WTO SPS
Agreement) and Precautionary Principle
• Relevance of Precautionary Principle to (WTO)
Article 5.1:
“…even if a (WTO) Member follows a precautionary
(principle) approach, its SPS measures need to be ‘based
on’ (i.e., ‘sufficiently warranted’ or ‘reasonably supported’
by) a risk assessment. Or, to put it another way, such an
approach needs to be applied in a manner consistent with
the requirements of (WTO) Article 5.1.”
Source: http://www.wto.org/english/res_e/booksp_e/analytic_index_e/sps_02_e.htm
Validity Criteria for Sanitary and Phytosanitary
Measures in International Trade
Source: Zepeda C., et al. 2001. Preventive Veterinary Medicine 48: 261-271.
Risk Analysis/Assessment
Review Concepts
•
•
•
•
What is risk?
What is risk analysis?
What is risk assessment?
Risk analysis and assessment processes
What is Risk?
• The likelihood of the occurrence and
the likely magnitude of consequences
(biologic & economic) of an adverse
event or effect to animal or human
health
Source: OIE Terrestrial Animal health Code 2011 (glossary)
Elements of Risk
• Probability (likelihood or chance) of an
adverse event (the hazard)
• Consequences (or impact)
– Biologic
– Economic
• Uncertainty
• Ability to manage
Critical Questions That Should Shape
Any Animal Health-Based Risk Analysis
• What can go wrong?
• How likely is the event(s) to occur?
• If the event(s) happen, what is/are
the consequence(s) and extent of
damage?
What is Risk Analysis?
• Organized way to answer those three
questions……
as well as incorporate:
• What can be done to change (mitigate)
the risk?
• Whom do we need to inform?
• What/how do we need to communicate?
What Is Risk Analysis?
How likely is the event to occur?
If the event happens, what are the biologic and economic consequences?
What can go wrong?
Hazard
Identification
What can be done to change (mitigate) the risk?
What must be done to implement mitigation(s)?
Risk
Assessment
Risk
Management
Risk Communication
Whom do we inform?
What/how do we need to communicate information?
Source: OIE Terrestrial Animal Health Code (2013)– Vol I: Section 2; Chapter 2.1.
http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.2.1.htm
Risk Analysis does NOT:
• Establish the “acceptable risk” level
• Describe with certainty when/if an
agent will be introduced or the
consequences
• Determine policy
• Provide the ONLY input into decision
making
33
What is Risk Assessment?
• Evaluation of the
likelihood of
entry,
establishment,
and spread of a
disease and the
associated
potential
biological and
economic
consequences to
animal and/or
public health
Hazard
Identification
Risk
Assessment
Risk Communication
Risk
Management
Risk Assessment
• Consists of:
– Entry (release) assessment
– Exposure assessment
– Consequence assessment
• Biologic
• Economic
– Risk estimation
Source: OIE Terrestrial Animal Health Code (2013)– Vol I: Section 2; Chapter 2.1.
http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.2.1.htm
Entry (Release) Assessment
• Describes the biological pathway(s)
necessary for an importation activity
to 'release' (introduce) a pathogen
into a particular environment
– Pathways analysis
• Estimates the probability of that
complete process occurring,
qualitatively (in words) or
quantitatively (as a numerical
estimate)
Pathways Analysis
Definition
Systematic assessment of the pathways
along which a foreign animal disease
agent might enter the US and establish
an outbreak of disease in animals and/or
man
Pathways Analysis
• Systematic assessment of the pathways
along which a foreign animal disease
might enter the US and establish an
outbreak of disease in animals and/or
man
• Also applicable for delineating the
pathways along which a domestic
disease agent might spread from a
state/province or region to new
state(s)/province(s) or region(s)
Pathways Analysis
Its Uses
• Risk assessment
• Targeted surveillance planning
• Emergency preparedness and
response
Pathways Analysis Steps
Step 1:
Establish an understanding of host,
agent, and environmental
interactions for the disease in
question based on scientific
literature, expert opinion, personal
experience or other sources of
information.
Pathways Analysis Steps
•Establish an understanding of host, agent, and
environmental interactions for the disease in question
based on scientific literature, expert opinion, personal
experience or other sources of information.
Step 2:
Develop a list of potential pathways
for entry of the disease agent into a
susceptible livestock and/or human
population
Pathways Analysis Steps
•Establish an understanding of host, agent, and
environmental interactions for the disease in question
based on scientific literature, expert opinion, personal
experience or other sources of information.
•Develop a list of potential pathways for entry of the
disease agent into a susceptible livestock and/or human
population
Step 3:
Evaluate the feasibility of each pathway
Pathways Analysis Steps
•Establish an understanding of host, agent, and
environmental interactions for the disease in question
based on scientific literature, expert opinion, personal
experience or other sources of information.
•Develop a list of potential pathways for entry of the
disease agent into a susceptible livestock and/or human
population
•Evaluate the feasibility of each pathway
•Step 4:
Identify the populations at-risk for
each feasible pathway that the
disease agent follows to enter the
country (or state/province or region)
Gaps in knowledge reduces the
certainty of the confidence to place
on feasibilty of some pathways
Exposure assessment
• describes the biological pathway(s)
necessary for exposure of animals and
humans in the importing country (or
state) to the hazards released from a
given risk source
• Estimate the probability of the
exposure(s) occurring, either qualitatively
(in words) or quantitatively (as a
numerical estimate)
– animal and/or people
Consequence assessment
• Describes the relationship between
specified exposures to a biological agent
and the consequences of those exposures
– Direct consequences
• animal infection, disease, and production losses
• public health consequences.
– Indirect consequences
•
•
•
•
surveillance and control costs
compensation costs
potential trade losses
adverse consequences to the environment
Risk estimation
• Integration of the results from:
– Release assessment
– Exposure assessment
– Consequence assessment
Quantitative Versus Qualitative
Risk Assessment
‘zero’ risk
does not
exist
50
Types of risk assessment
• Quantitative
• Qualitative
Quantitative Risk
Assessment
• an assessment where the outputs of
risk are expressed numerically
– Objective in nature
– This number can represent the
probability of an event occurring during
a specific time frame
• Disease “X” will enter The Bahamas one out
of every 10,000 shipments of product “a”
Quantitative studies
Advantages
• More profound
• Notion of the
probability of
occurrence of an
adverse event
• Informed decisonmaking
Disadvantages
• Require time
• Require good quality
data
• Not possible to apply
in all circumstances
yes
Scenario Tree
yes
no
yes
yes
NO RISK
no
NO RISK
no
Detected at
inspection?
animal
infected?
Herd
infected?
Survives
processing?
NO RISK
yes
Susceptible
species
exposed?
NO RISK
no
NO RISK
no
RISK
Uncertainty
• There are no exact values for each parameter
• It is necessary to produce an estimate that
incorporates uncertainty and variability
• Use of simulation programs
Results
X <=0
5%
0.25
X <=0.01
95%
Probability
0.2
0.15
0.1
• Not a point estimate
but a range of
probabilities
0.05
0
0
3
6
9
12
Values in 10^-3
• The result reflects
variability and
uncertainty
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.29
0.27
0.26
0.24
0.23
0.2
0.21
0.18
0.17
0.15
0.14
0.12
0.11
0.09
0.08
0.06
0.05
0.03
0.02
0
0
Prob of Value <= X-axis Value
1
0.9
56
Qualitative Risk Assessment
• Not always possible to quantify risks
because there simply may not be
enough data to make reliable
calculations
• An assessment where the outputs for
the likelihood of the outcome or the
magnitude of the consequences are
expressed in qualitative terms such as
‘high’, ‘medium’, ‘low’ or ‘negligible’
– Subjective in nature
Qualitative studies
Advantages
• Faster
• Applicable to a
broader scope of
circumstances
Disadvantages
• Less profound
• Do not provide a
numerical probability
of occurrence of an
adverse event
• Less precise
decision-making
Risk Analysis Process
Hazard
Identification
Risk
Assessment
Risk Communication
Source: OIE Terrestrial Animal Health Code (2013)– Vol I: Section 2; Chapter 2.1.
http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.2.1.htm
Risk
Management
Questions?