Relevance of Risk Analysis/Assessment to International Trade and the Precautionary Principle Tom...
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Relevance of Risk Analysis/Assessment to International Trade and the Precautionary Principle Tom Kasari, DVM, MVSc Diplomate, American College Veterinary
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
Slide 2
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
Slide 3
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
Slide 4
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
Slide 5
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 Relevance of Risk
Analysis/Assessment to International Trade (WTO SPS Agreement)
Source:
http://www.wto.org/english/thewto_e/coher_e/wto_oie_e.htm
Slide 6
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 Relevant international
organization for animal health: World Organization for Animal
Health (aka Office International des Epizooties or OIE) Relevance
of Risk Analysis/Assessment to International Trade (WTO SPS
Agreement) Source:
http://www.wto.org/english/thewto_e/coher_e/wto_oie_e.htm
Slide 7
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
Slide 8
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
Slide 9
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)
Slide 10
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
Slide 11
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
Slide 12
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
Slide 13
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.
subpopulationdiseaseinternational trade
Slide 14
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.establishmentssubpopulation diseasediseases international
trade
Slide 15
Definition Recognition of animal populations of different
health status Zoning/regionalization Geographical basis
Compartmentalization Management and biosecurity
Slide 16
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
Slide 17
Interstate Trade States swine industry Regionalization =
establishing and maintaining a disease free status for a
subpopulation of animals based on a geographical basis Interstate
Trade Regionalization
Slide 18
Slide 19
States swine industry Compartmentalization = establishing and
maintaining a disease free status for a subpopulation of animals
based on management systems related to management and biosecurity
Interstate Trade Compartmentalization
Slide 20
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
Slide 21
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
Slide 22
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.
Slide 23
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
Slide 24
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
Slide 25
Validity Criteria for Sanitary and Phytosanitary Measures in
International Trade Source: Zepeda C., et al. 2001. Preventive
Veterinary Medicine 48: 261-271.
Slide 26
Risk Analysis/Assessment
Slide 27
Review Concepts What is risk? What is risk analysis? What is
risk assessment? Risk analysis and assessment processes
Slide 28
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)
Slide 29
Elements of Risk Probability (likelihood or chance) of an
adverse event (the hazard) Consequences (or impact) Biologic
Economic Uncertainty Ability to manage
Slide 30
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?
Slide 31
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?
Slide 32
What Is Risk Analysis? Hazard Identification Risk Assessment
Risk Management 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
What can go wrong? How likely is the event to occur? If the event
happens, what are the biologic and economic consequences? What can
be done to change (mitigate) the risk? What must be done to
implement mitigation(s)? Whom do we inform? What/how do we need to
communicate information?
Slide 33
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
Slide 34
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 Management Risk
Communication
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)
Slide 37
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
Slide 38
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)
Slide 39
Pathways Analysis Its Uses Risk assessment Targeted
surveillance planning Emergency preparedness and response
Slide 40
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.
Slide 41
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
Slide 42
Slide 43
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
Slide 44
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)
Slide 45
Gaps in knowledge reduces the certainty of the confidence to
place on feasibilty of some pathways
Slide 46
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
sourceimporting countryhazardsrisk Estimate the probability of the
exposure(s) occurring, either qualitatively (in words) or
quantitatively (as a numerical estimate) animal and/or people
Slide 47
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
Slide 48
Risk estimation Integration of the results from: Release
assessment Exposure assessment Consequence assessment
Slide 49
Quantitative Versus Qualitative Risk Assessment
Slide 50
zero risk does not exist 50
Slide 51
Types of risk assessment Quantitative Qualitative
Slide 52
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
Slide 53
Quantitative studies Advantages More profound Notion of the
probability of occurrence of an adverse event Informed decison-
making Disadvantages Require time Require good quality data Not
possible to apply in all circumstances
Slide 54
RISK Herd infected? Detected at inspection? animal infected?
Survives processing? Susceptible species exposed? yes no NO RISK
Scenario Tree
Slide 55
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
Slide 56
Results Not a point estimate but a range of probabilities The
result reflects variability and uncertainty 56
Slide 57
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
Slide 58
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
Slide 59
Risk Analysis Process Hazard Identification Risk Assessment
Risk Management 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
