Transcript SPS AGREEMENT - FAO GLOBEFISH

ESTABLISHING PRODUCT
STANDARDS AND
CERTIFICATION SYSTEMS
Iddya Karunasagar
Fish Utilisation and Marketing Service
FAO, Rome
SPS AND TBT AGREEMENTS
Introduce new disciplines that govern trading
practices at international level
Set out rights and responsibilities of WTO
members
That wish to take action to restrict imports in order to
protect human, animal or plant health
When applying technical regulations and standards
and conformity assessment procedures for traded
goods
SPS AGREEMENT
RIGHT: to ensure that consumers are being
supplied safe food
Safe by the standards the country considers
appropriate
OBLIGATION: to ensure that strict health and
safety regulations are not being used as an
excuse for protecting domestic producers
SPS AGREEMENT
Restrictions should be minimum necessary to
human, animal or plant health
They should be based on scientific principles
and not maintained without sufficient scientific
evidence
Governments must notify each other of SPS
measures in the course of preparation
SPS AGREEMENT
Members are encouraged to adhere to
international standards where they exist
Higher standards can be enforced, if there is
scientific justification provided in accordance
with internationally accepted risk assessment
techniques
SPS AGREEMENT
Members should accept SPS measures of other
countries as equivalent, even if different, where
they provide the same level of protection as their
own regulations
Control, inspection and approval procedures
should be undertaken in no less favourable
manner for imported products than for similar
domestic products
SPS AGREEMENT
With regard to food safety measures, members
should base their national measures on
international standards, guidelines adopted by
Codex Alimentarius Commission (CAC)
For Animal life and health, measures should be
based on standards and guidelines adopted by
the International Office of Epizootics (OIE)
SPS AGREEMENT
Article-1 General Provisions
Annex A Definitions
Sanitary/Phytosanitary Measures
Any measure applied to Protect Human and Animal
Life or Health from Risks from
improper use of food additives
contaminants
toxins
disease causing organisms in foods,
beverages or feedstuffs
SPS AGREEMENT
Article-1 General Provisions
Annex A Definitions
Sanitary/Phytosanitary Measures
Any measure applied to Protect Animal or Plant
Life within the territory of the Member from risks
related to the entry, establishment or spread of:
Pests or diseases
Disease carrying organisms
Disease causing organisms
SPS AGREEMENT
Annex A - Definitions
Sanitary/Phytosanitary Measures
include all laws, decrees, regulations,
requirements and procedures related to
 end product criteria
 processes
 production methods
 testing
 inspection
 certification
 approval
procedures
 quarantine treatments
 statistical methods
 sampling procedures
 risk assessment
 packaging
 labelling
DEFINING PRINCIPLES OF SPS AGREEMENT
(Article 2)
ADEQUACY: measures should only be applied
to the extent to protect the health
JUSTIFICATION: measures should be based on
scientific evidence
NON DISCRIMINATION: measures should not
arbitrarily or unjustifiably discriminate, where
identical or similar conditions prevail.
TBT AGREEMENT
Tries to prevent standards becoming obstacles
for trade
Products imported from any WTO member
receiving no less favorable treatment given to
similar product of national origin or originating in
any other country
Standards should be based on legitimate
objectives, be drafted in terms of performance
rather than design
TBT AGREEMENT
 Governments should notify each other of standards in
the course of preparation
 Members are encouraged to adhere to international
standards, where possible
 Accept standards of other countries as equivalent,
even if different, where they meet objectives of their
own regulations
 Foreign suppliers should have access to conformity
assessment procedures on terms no less favourable
than domestic producers
TBT AGREEMENT
Covers all types of consumer products including
foods
Does not apply to requirements covered by SPS
agreement
Covers measures designed to protect consumer
against deception and fraud
TBT AGREEMENT
States that all technical standards and
regulations must have a legitimate purpose
The impact or cost of implementing a standard
must be proportional to the purpose f the
standard
If there are two or more ways of achieving the
same objective, the least trade restrictive
alternative should be followed
Technical Barriers to Trade
Agreement (TBT)
Annex 1. Definitions
Technical regulation
Document which lays down product
characteristics or their related processes and
production methods, including the applicable
administrative provisions, with which
compliance is mandatory. It may also include
or deal exclusively with terminology,
symbols, packaging, marking or labelling
requirements as they apply to a product,
process or production method.
Technical Barriers to Trade
Agreement (TBT)
Annex 1. Definitions
Standard
Document approved by a recognized body, that
provides, for common and repeated use, rules,
guidelines or characteristics for products or related
processes and production methods, with which
compliance is not mandatory. It may also include or
deal exclusively with terminology, symbols,
packaging, marking or labelling requirements as
they apply to a product, process or production
method.
Technical Barriers to Trade
Agreement (TBT)
Annex 1. Definitions
Conformity assessment procedures
Any procedure used, directly or
indirectly, to determine that relevant
requirements in technical
regulations or standards are
fulfilled.
Implications of the SPS and TBT
agreements in Fisheries
SPS/TBT Agreements
General Principles
 Sovereignty
 Harmonization
 Equivalency
 Scientific basis
 Transparency
 Technical Assistance
 Special and differential treatment
 Consultation and dispute settlement
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation
and dispute
settlement
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SPS
 AGREEMENT
Each country is
Annex
A
sovereign
to establish
Definitions
SPS measures it terms
necessary
toof
protect
Appropriate
Level
Protection
human and animal health
The and
levelplants
of protection deemed
appropriate by the Member to
protect human, animal or plant life
or health
“Acceptable Level of Risk”
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation and
dispute
settlement
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SPS AGREEMENT
Article 2
Basic Rights
Recognizes the rights of
Members to establish appropriate
levels of protection

Outlines the application of scientific
evidence in establishing
sanitary/phytosanitary measures
 Prohibits discriminatory, disguised
or unnecessary restrictive trade
measures
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation and
dispute
settlement
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The TBT Agreement
establishes rights of Members:
to ensure the quality of its exports,
to protect human, animal or plant
life or health
to protect the environment
 or for the prevention of deceptive
practices, at the levels considered
appropriate
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation and
dispute
settlement
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SPS AGREEMENT
Annex A
Definitions
Harmonization
Establishment, Recognition and
Application of Common
Sanitary/Phytosanitary
Measures by Members
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation and
dispute
settlement
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SPS AGREEMENT
Annex A
Definitions: Harmonization
Codex Alimentarius Commission
Standards, Guidelines, and
Recommendations for Food Safety
Food Additives
Veterinary Drug and Pesticide
Residues
Contaminants
Methods of Analysis and Sampling
Codes /Guidelines of Hygienic Practices
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation
and dispute
settlement
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SPS AGREEMENT
Annex A
Definitions: Harmonization
Standards, Guidelines, and
Recommendations for Animal
Health and Zoonoses
International Office of Epizootic
Standards, Guidelines, and
Recommendations for Plant Health
International Plant Protection
Convention
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation and
dispute
settlement
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SPS AGREEMENT
Annex A
Definitions: Harmonization
For matters not covered by the
identified Organizations
Standards, guidelines, and
recommendations promulgated by
other international organizations,
open for membership to All WTO
members, as identified by the SPS
Committee may be applied
SPS/TBT Agreements
General Principles
SPS AGREEMENT
Article 3
Harmonization
Sovereignty
Harmonization
Equivalence
Members shall base Sanitary and
Scientific basis
Phytosanitary Measures on international
Transparency
standards, guidelines and recommendations
Technical
Assistance
 Special and
Measures which conform to international
differential
standards are consistent with Agreement
treatment
 Consultation and
dispute
Higher level of protection may be used
settlement
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SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation
and dispute
settlement
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SPS AGREEMENT
Article 3
Harmonization
Members are to fully participate in
relevant international organizations
WTO to monitor progress of
international harmonization
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation and
dispute settlement
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SPS AGREEMENT
Article 4
Equivalence
Members shall accept other Member
measures as
equivalent, if final results are the
same
Members shall consult to achieve
bilateral and multilateral agreement
(Mutual Recognition Agreements)
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation and
dispute settlement
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SPS AGREEMENT
Article 5
Risk Assessment
Risk Assessment should take into account

available scientific evidence
SPS
Measures are to be based on an

relevant processes and production
assessment
of the risks to Human,
methods
Animal
and Plant life and methods
health
inspection/sampling/testing
prevalence
of specific diseases
or Risk
pests
using
internationally
accepted
existence ofTechniques
pest/disease free areas
Assessment
ecological/environmental conditions
quarantine or other treatment
SPS/TBT Agreements
SPS AGREEMENT
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation
and dispute
settlement
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Article 5: Risk Assessment
SPS Measures should
minimize negative trade effects
Arbitrary or unjustified measures
shall not be considered
Members may provisionally
adopt international Standards
Protection level shall not be
trade restrictive
Explanations may be requested by
Members
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation and
dispute
settlement
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SPS AGREEMENT
Article 7
Transparency
Publication of regulations and
provide lead time for comment
Establish Enquiry Point
Establish Notification Procedures
 General Reservations (related to
Confidential information)
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation and
dispute
settlement
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SPS AGREEMENT
Article 7
Transparency
Emergency circumstances
 Bypass publication
 Immediately notify Members
through SPS Committee Secretariat
 Allow Members to comment and
take comments into account
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation and
dispute
settlement
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SPS AGREEMENT
Article 7
Transparency
Notification Procedures
Prompt publication

Provide information on effected
products, objectives and rational
Provide copies of regulation
on request
Allow Members to comment and take
comments into account
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation
and dispute
settlement
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SPS AGREEMENT
Article 9
Technical Assistance
Members agree to facilitate technical
assistance, especially to developing
countries
If substantial investment is needed,
technical assistance should be provided
(WTO is not a funding organization)
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation and
dispute settlement
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SPS AGREEMENT
Article 10: Special and Differential Treatment
Members are to consider needs of
other Member countries
Time limit exception (granted by SPS
Committee upon request)
Longer time frames for compliance with
this agreement
Developing countries should actively
participate in international organizations
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation
and dispute
settlement
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SPS AGREEMENT
Article 11
Consultations and Dispute Settlement
Rules established by GATT (Article XXII
and XXIII)
Technical/Scientific - advise from experts,
advisory panels or relevant international
organizations
Other existing international agreements
may be used

SPS/TBT Agreements
General Principles SPS AGREEMENT
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation
and dispute
settlement
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Article 11
Administration
The SPS Committee was established to
encourage the use of International
Standards
maintain contact with international
organizations
develop procedures to monitor
harmonization
monitor for duplication of procedures
examine specific standards
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 review operational procedures after3 years
SPS/TBT Agreements
General Principles
Sovereignty
Harmonization
Equivalence
Scientific basis
Transparency
Technical
Assistance
 Special and
differential
treatment
 Consultation and
dispute
settlement
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TBT AGREEMENT
The Committee on TBT
Meets as necessary, at least once a year
To enable members to consult on the
operations of the agreement
Committee can establish working
parties or other bodies as appropriate
Committee to ensure duplication with
other technical bodies is prevented
Achievements and Challenges
Harmonization
Equivalence
Scientific basis
Special and differential
treatment/Technical assistance
Achievements and Challenges
 Harmonization
 Equivalence
 Scientific basis
 Special and
differential
treatment/
Technical
assistance
Achievements:
HACCP-based systems
widely accepted
Codex Alimentarius
Commission accepted as the
international standards setting
body
Shortcomings:
Different inspection and control
schemes
Different fish standards applied
High rates of detentions/rejections
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Achievements and Challenges
 Harmonization
 Equivalence
 Scientific
basis
 Special and
differential
treatment/
Technical
assistance
Achievements:
 “Food chain” and “Control at source”
approaches
 Cost-effectiveness of these approaches
Shortcomings:
 Very few agreements
 Obligation of means vs. obligation of results
Achievements and Challenges
 Harmonization
 Equivalence
 Scientific
basis
 Special and
differential
treatment/
Technical
assistance
Achievements:
Risk analysis widely accepted
National and International
work undertaken
Shortcomings:
Needs exceed by far activities undertaken
Lack of resources in developing countries
Many standards not scientifically based
Achievements and Challenges
 Harmonization
 Equivalence
 Scientific basis
 Special and
differential
treatment/
Technical
assistance
Achievements:
Regional and national initiatives (SIDA,
EC-ACP)
STDF (Standard and Trade
Development Fund)
Trust Fund for CAC
Shortcomings:
 Developing countries obliged to meet market
requirements
 Needs exceed by far initiatives
 Lack of resources in developing countries
 Many standards not scientifically based
Risk Analysis
Risk Assessment
Hazard identification
Risk Management
Risk Communication
Hazard
characterisation
Exposure assessment
Risk characterisation
Risk Analysis Components
 (Quantitative) Risk Assessment
How big is the risk, what factors control the risk?
Scientific process
 Risk Communication
How can we talk about the risk with affected individuals?
Social and psychological process
 Risk Management
What can we do about the risk?
Political process
'risk assessment' means a scientifically based process
consisting of four steps: hazard identification, hazard
characterisation, exposure assessment and risk
characterisation;
'risk management' means the process, distinct from risk
assessment, of weighing policy alternatives in consultation
with interested parties, considering risk assessment and
other legitimate factors, and, if need be, selecting
appropriate prevention and control options;
'risk communication' means the interactive exchange of
information and opinions throughout the risk analysis
process as regards hazards and risks, risk-related factors
and risk perceptions, among risk assessors, risk managers,
consumers, feed and food businesses, the academic
community and other interested parties, including the
explanation of risk assessment findings and the basis of risk
management decisions;
MICROBIOLOGICAL RISK ASSESSMENT
 A scientific process which consists of determining the
likelihood and severity of an adverse health effect in a
population exposed to a certain pathogen/food
combination
PURPOSE OF MICROBIOLOGICAL RISK
ASSESSMENT
 Facilitate and support decision making by risk
managers
 This may be achieved by providing:
- Estimates of risk of illness by consumption
of certain food/pathogen combination
- Estimates of risk reduction that may be
achieved by certain control measures
ACCEPTABILITY OF RISK IS NOT EXPRESSED
IN MRA
 A risk estimate does not provide information whether
the risk associated with the level (prevalence and/or
concentration) of microbe in food is acceptable or not.
 This is a decision that society (stakeholders:
Government agencies, industry, academicians,
consumers, politicians) should take
RISK ASSESSMENT AREAS
 Microbiological
 Chemical
 Biotechnological
Microbiological hazards
vs chemical hazards
Microbiological hazards:
Usually acute effect
• Single exposure
• Pathogen/commodity
combination
• Living hazards - numbers can
change up or down
• Dynamic and adaptable different characteristics &
variable response
• Difficult to define acceptable
levels
Chemical hazards:
• Usually cumulative effect
• Multiple exposures
• One chemical - many foods
• Toxic levels stable or decrease
during storage
• Processing has minimal effect
• Acceptable levels defined for
many chemical hazards
MICROBIOLOGICAL RISK ASSESSMENT
Microbiological risk assessment is a science
based process driven by Governments to
assess
the severity of illness
and the probability of its occurrence
as a consequence of the exposure to certain
pathogen/food combination
Risk Assessment - Codex
Hazard
identification
Hazard
characterization
Risk
characterization
Exposure
assessment
Step in Risk Assessment
Hazard Identification
What microbe, food(s) and people are involved?
Hazard characterisation
Characteristics of pathogen, food, public health
outcomes
Exposure Analysis
What is the chance of exposure?
How many cells?
Dose-Response Analysis
What is the human health effect of the exposure?
Risk Characterization
Complete picture of the assessed risk
HAZARD IDENTIFICATION
“THE IDENTIFICATION OF KNOWN OR POTENTIAL HEALTH
EFFECTS ASSOCIATED WITH A PARTICULAR AGENT”
HAZARD CHARACTERISATION
“THE QUALITATIVE AND/OR QUANTITATIVE EVALUATION
OF THE NATURE OF THE ADVERSE EFFECTS ASSOCIATED
WITH BIOLOGICAL, CHEMICAL AGENT WHICH MAY BE
PRESENT IN FOODS. A DOSE-RESPONSE ASSESSMENT
SHOULD BE MADE IF DATA IS AVAILABLE”
Hazard Identification
 Epidemiological data linking
Foods
Pathogens
Human illness
 Special considerations
Disease complications
Acute vs. chronic disease
Specific sensitive consumer populations
Characteristics of the organism
Organisms mode of action
Exposure - Simple Example
Initial number of organisms follows a Poisson
distribution
Growth rate is normally distributed
Product composition and storage temperature
are fixed
The product becomes unsafe when it contains
100,000 organisms/gram
Fraction of samples
Initial number - Poisson
0.4
0.3
0.2
0.1
0.0
0
1
2
3
4
5
Number of Microbes
6
7
Frequency
Growth rate is normal
0.14
0.12
0.10
0.08
0.06
0.04
0.02
0.00
15
20
25
30
35
40
Doubling Time (hr)
45
Simulation Results
0.4
Frequency
0.3
0.2
0.1
0.0
Never
0
10
20
30
40
Days until to 105 microbes/gram
Dose-Response Analysis
Translates exposure analysis output in
to a measure of human health
If “quantitative”
Use dose-response curve
Estimate probability of infection and illness
from dose
Dose response curve
Dose-Response factors
Statistical model(s) to analyze or quantify doseresponse relationships
Threshold vs. non-threshold models
Dose response data
Human
Animal
Outbreak or intervention data
Dose-Response factors
Source and preparation of challenge material or
inoculum
Organism type and strain
Virulence factors or other measures of pathogenicity
Characteristics of the exposed population
Age, immune status, etc.
EXPOSURE ASSESSMENT
“THE QUALITATIVE AND/OR QUANTITAIVE EVALUATION OF
THE THE DEGREE OF INTAKE THAT IS LIKELY TO OCCUR”
RISK CHARACTERISATION
“INTEGRATION OF HAZARD IDENTIFICATION, HAZARD
CHARACTERISATION AND EXPOSURE ASSESSMENT INTO AN
ESTIMATION OF THE ADVERSE EFFECT LIKELY TO OCCUR IN
A GIVEN POPULATION INCLUDING ATTENDANT
UNCERTAINTIES”
Exposure Analysis
Estimate
likelihood of consumption
likely number (dose) of the pathogen
If “quantitative” assessment
Modeling
Simulation
Risk Characterization
Final task in risk assessment
Combines the information from
Hazard identification
Exposure analysis
Dose-response analysis
Produces a complete picture of the
assessed risk
Inputs to MRA
Science (multidisciplinary)
• Data
• Knowledge
• Experts
Tools
• Statistics
• Ranking
• Simulation (e.g. Monte
Carlo)
• Knowledge elicitation
Infrastructure
• Epidemiology
• Food consumption
• Outbreak
investigation
• Consumer
behaviour
Framework
• Risk analysis
Iterative process of MRA
Collect data
Define assumptions
Develop model
Run simulation
Review results
Need more data?
Assumptions not suitable?
NO
Estimate risk
Validate
Revise model
YES
Codex principles for MRA (1)
1. MRA should be soundly based on science
2. There should be a functional separation
between risk assessment and risk management
3. MRA should be conducted according to a
structured approach that includes hazard
identification, hazard characterization, exposure
assessment and risk characterization
Codex principles for MRA (2)
4. An MRA should clearly state the purpose of
the exercise, including the form of risk
estimate that will be the output
5. The conduct of an MRA should be
transparent
6. Any constraints that impact on the MRA,
such as cost, resources or time, should be
identified and their possible consequences
described
Codex principles for MRA (3)
7. The risk estimate should contain a description
of uncertainty and where the uncertainty arose
during the risk assessment process
8. Data should be such that uncertainty in the risk
estimate can be determined; data and data
collection systems should, as far as possible,
be of sufficient quality and precision that
uncertainty in the risk estimate is minimized
Codex principles for MRA (4)
9. An MRA should explicitly consider the dynamics of
microbiological growth, survival and death in food
and the complexity of the interaction (including
sequelae) between human and agent following
consumption as well as the potential for further
spread
10. Wherever possible, risk estimates should be
reassessed over time by comparison with
independent human illness data
11. An MRA may need re-evaluation, as new relevant
information becomes available
Different applications of MRA
 One pathogen/one food
 One pathogen/multiple foods
 Introduction of hazard into a region
 Comparison of different control measures
 Comparing risks in more than one domain (e.g. use
of chlorine versus risk of water-borne diseases)
Outcomes of MRAs
1. The chance of a person falling ill by consuming a
food
2. The estimated number of cases of a certain illness
(e.g. per 100 000 per year in a country) due to
consumption of a specific food
3. The relative risk posed by a pathogen in different
food products or uses
4. Risk estimates for different processing, distribution
and consumer use conditions and risk reduction
scenarios
Predicted mean annual number of illness for three
alternative target levels
Target V. vulnificus/g
3/g
30/g
300/g
Mean annual illness
0.16
1.2
7.7
VIBRIO VULNIFICUS RISK ASSESSMENT
 Validated approaches for post-harvest processing of
oysters to achieve end point criterion of <3 MPN/g
mild heat treatment (50C)
freezing with extended frozen storage
high hydrostatic pressure
1
2
3
Risk assessment of Vibrio
parahaemolyticus in raw oysters
4
5
Interpretative summary
6
and Technical report
7
8
9
10
11
12
July 2007 (FAO)
13
14
15
16
17
18
Food and Agriculture Organization of the United Nations
19
World Health Organization
20
2007
21
Regional, seasonal and
yearly variation
Water
temperature
Water salinity
Total Vp/g
Pathogenic
Vp/g
HARVEST MODULE OF RA MODEL
Vp/g at
harvest
Time to
refrigeration
Air
temperature
Vp/g at first
refrigeration
Cool down
time
Vp/g at cool
down
Storage
time
Vp/g at
consumption
POST HARVEST MODULE OF RA MODEL
FACTORS USED TO MODEL EXPOSURE
Level of pathogenic V. parahaemolyticus in
oyster at harvest
Effect of postharvest handling and processing
Ability of the organism to multiply to an infective
dose
Number of pathogenic V. parahaemolyticus
consumed
Table 2: Predicted annual illnesses of V. parahaemolyticus
following consumption of oysters in Japan, Australia, NZ, Canada
and USA
JanAprJulOctMar
Jun
Sep
Dec
Hiroshima Bay,
0
0
0
38
Japan
Wallis Lake,
19
1
0
7
Australia
Orongo Bay, New
0
0
0
0
Zealand
British Columbia,
0
18
168
0
Canada
USA Gulf
10
698 1,705 183
USA North Atlantic
0
3
14
2
USA Mid Atlantic
0
4
7
4
USA Pacific NW
0
18
177
1
Table 3: Predicted annual illnesses of V. parahaemolyticus
following consumption of oysters in Japan, Australia, NZ, and
Canada
Annual
cases
Annual
predicted
cases
by model
predicted Epidemiological
for the
Proportion by
evidence for V.
specified (%) of
model
parahaemolyticus
growing
total
for
illness from oyster
area
production nation
consumption
2 cases in 18 years;
two large outbreaks
Wallis
from other seafood
Lake
27
30
91
sources
None during 19972002 from oysters;
several outbreaks
Orongo
from other seafood
Bay
0
15
0
sources
Hiroshima
13 during 1998Bay
38
57.2
66
2004
BC,
212 in decade
Canada
186
100
186
1997-2006 in BC
Factors influencing the output in the model
Under reporting of illness (20:1 in US model)
Levels of pathogenic V. parahaemolyticus ( In
US, Pacific coast, 2%-4%; overall, 0.1% to
0.3%)
Growth of V. parahaemolyticus in various oyster
species (no growth in Sydney rock oyster at 30C
for seven days)
Table 31: Reduction in illness, based on meeting specified target
numbers of V. parahaemolyticus, together with commensurate
rejection of product for raw consumption
Reduction (%) in the
Product (%) rejected to
number of predicted
achieve these reductions
illnesses
in illness
Specifie Austra
New
Japan Austra
New
Japan
d target
lia
Zealand (autu
lia
Zealand (autu
(sum (summer mn)
(sum (summer mn)
mer)
)
mer)
)
100
99
96
99
67
53
16
cfu/g
1000
87
66
97
21
10
5
cfu/ g
10000
52
20
90
2
1
1
cfu/g
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