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SPS AGREEMENT

VIEWS: 4 PAGES: 93

									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    quarantine treatments
  processes               statistical methods
  production methods      sampling procedures
  testing                 risk assessment
  inspection              packaging
  certification           labelling
  approval
   procedures
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        SPS AGREEMENT is
                          Each country
 Equivalence          Annex A
                           sovereign to establish
 Scientific basis     Definitions
                           SPS measures it terms
 Transparency             necessary to protect
                       Appropriate Level of Protection
 Technical                human and animal health
  Assistance           The and plants
                           level of protection deemed
 Special and          appropriate by the Member to
  differential
  treatment
                     protect human, animal or plant life
 Consultation                    or health
  and dispute
  settlement             “Acceptable Level of Risk”
 SPS/TBT Agreements
 General Principles                    SPS AGREEMENT
                                            Article 2
 Sovereignty                             Basic Rights


  Harmonization
  Equivalence
                      Recognizes the rights of
                     Members to establish appropriate
 Scientific basis   levels of protection


  Transparency
  Technical          Outlines the application of scientific
  Assistance         evidence in establishing
                     sanitary/phytosanitary measures
 Special and
  differential
  treatment
                      Prohibits discriminatory, disguised
                       or unnecessary restrictive trade
 Consultation and     measures
  dispute
  settlement
    SPS/TBT Agreements
    General Principles
 Sovereignty
 Harmonization
                               The TBT Agreement
 Equivalence             establishes rights of Members:
 Scientific basis
 Transparency       to ensure the quality of its exports,
 Technical
  Assistance         to protect human, animal or plant
 Special and        life or health
  differential       to protect the environment
  treatment
 Consultation and
                      or for the prevention of deceptive
                       practices, at the levels considered
  dispute              appropriate
  settlement
SPS/TBT Agreements
General Principles
                     SPS AGREEMENT
 Sovereignty        Annex A
 Harmonization
                     Definitions
 Equivalence
 Scientific basis
                     Harmonization
 Transparency
 Technical
  Assistance
                     Establishment, Recognition and
 Special and        Application of Common
  differential       Sanitary/Phytosanitary
  treatment          Measures by Members
 Consultation and
  dispute
  settlement
SPS/TBT Agreements
General Principles              SPS AGREEMENT
 Sovereignty
                     Annex A
 Harmonization
                     Definitions: Harmonization
 Equivalence
                     Codex Alimentarius Commission
 Scientific basis
                      Standards, Guidelines, and
 Transparency
                      Recommendations for Food Safety
 Technical
  Assistance
                     Food Additives
 Special and
                     Veterinary Drug and Pesticide
                     Residues
  differential
  treatment          Contaminants
 Consultation and   Methods of Analysis and Sampling
  dispute            Codes /Guidelines of Hygienic Practices
  settlement
SPS/TBT Agreements
General Principles                  SPS AGREEMENT
 Sovereignty                             Annex A
 Harmonization                 Definitions: Harmonization
  Equivalence

 Scientific basis   Standards, Guidelines, and
 Transparency       Recommendations for Animal
 Technical          Health and Zoonoses
  Assistance         International Office of Epizootic
 Special and
  differential
  treatment
                     Standards, Guidelines, and
                     Recommendations for Plant Health
 Consultation       International Plant Protection
  and dispute
  settlement         Convention
SPS/TBT Agreements
                              SPS AGREEMENT
General Principles            Annex A
 Sovereignty                 Definitions: Harmonization
 Harmonization
 Equivalence        For matters not covered by the
 Scientific basis   identified Organizations
 Transparency
 Technical            Standards, guidelines, and
  Assistance
                       recommendations promulgated by
 Special and
  differential         other international organizations,
  treatment            open for membership to All WTO
 Consultation and     members, as identified by the SPS
  dispute              Committee may be applied
  settlement
SPS/TBT Agreements
General Principles                SPS AGREEMENT
 Sovereignty                          Article 3
 Harmonization                     Harmonization
 Equivalence
 Scientific basis  Members shall base Sanitary and
 Transparency     Phytosanitary Measures on international
 Technical        standards, guidelines and recommendations
  Assistance
 Special and
  differential
                    Measures which conform to international
  treatment
                   standards are consistent with Agreement
 Consultation and
  dispute
  settlement
                     Higher level of protection may be used
SPS/TBT Agreements
General Principles
 Sovereignty                 SPS AGREEMENT
 Harmonization
                                   Article 3
 Equivalence
                                Harmonization
 Scientific basis
 Transparency
 Technical
  Assistance
                     Members are to fully participate in
                     relevant international organizations
 Special and
  differential
  treatment
 Consultation
  and dispute
                     WTO to monitor progress of
                     international harmonization
  settlement
SPS/TBT Agreements
                                    SPS AGREEMENT
General Principles                       Article 4
 Sovereignty
 Harmonization                        Equivalence
 Equivalence
 Scientific basis     Members shall accept other Member
 Transparency         measures as
 Technical             equivalent, if final results are the
  Assistance           same
 Special and
  differential         Members shall consult to achieve
  treatment            bilateral and multilateral agreement
 Consultation and     (Mutual Recognition Agreements)
  dispute settlement
SPS/TBT Agreements
                                    SPS AGREEMENT
General Principles                       Article 5
 Sovereignty                        Risk Assessment
 Harmonization
                       Risk Assessment should take into account
 Equivalence
                             available scientific to be based on an
                                                   evidence
 Scientific basis           relevant processesrisks to Human,
                            SPS Measures are and production
 Transparency              assessment of the
                             methods
 Technical                  inspection/sampling/testing health
                            Animal and Plant life and methods
  Assistance                 prevalence of specific accepted pests
                            using internationally diseases or Risk
 Special and                existence of pest/disease
                            Assessment Techniques free areas
  differential               ecological/environmental conditions
  treatment                  quarantine or other treatment
 Consultation and
  dispute settlement
SPS/TBT Agreements
General Principles SPS AGREEMENT
 Sovereignty                 Article 5: Risk Assessment
 Harmonization      SPS Measures should
 Equivalence        minimize negative trade effects


  Scientific basis
  Transparency
                     Arbitrary or unjustified measures
                     shall not be considered
 Technical
  Assistance         Members may provisionally
 Special and        adopt international Standards
  differential
  treatment
                     Protection level shall not be
                     trade restrictive
 Consultation
  and dispute
  settlement
                     Explanations may be requested by
                     Members
SPS/TBT Agreements
                                 SPS AGREEMENT
General Principles                    Article 7
 Sovereignty
 Harmonization                     Transparency
  Equivalence

 Scientific basis   Publication of regulations and
 Transparency       provide lead time for comment
 Technical
  Assistance         Establish Enquiry Point
 Special and
  differential
  treatment
                     Establish Notification Procedures
 Consultation and
  dispute             General Reservations (related to
  settlement         Confidential information)
SPS/TBT Agreements
General Principles           SPS AGREEMENT
 Sovereignty                     Article 7
 Harmonization                 Transparency
 Equivalence              Emergency circumstances
 Scientific basis
                      Bypass publication
 Transparency
 Technical
  Assistance          Immediately notify Members
                       through SPS Committee Secretariat
 Special and
  differential
  treatment           Allow Members to comment and
 Consultation and     take comments into account
  dispute
  settlement
    SPS/TBT Agreements
                                   SPS AGREEMENT
    General Principles                   Article 7
 Sovereignty                          Transparency
 Harmonization                  Notification Procedures


  Equivalence
  Scientific basis
                      Prompt publication
 Transparency       Provide information on effected
 Technical          products, objectives and rational
  Assistance
 Special and
  differential
                     Provide copies of regulation
  treatment          on request
 Consultation and
  dispute
                     Allow Members to comment and take
  settlement         comments into account
SPS/TBT Agreements
General Principles                 SPS AGREEMENT
 Sovereignty                           Article 9
 Harmonization                   Technical Assistance
 Equivalence
 Scientific basis   Members agree to facilitate technical
 Transparency        assistance, especially to developing
 Technical          countries
  Assistance
 Special and
  differential
                     If substantial investment is needed,
  treatment          technical assistance should be provided
 Consultation
  and dispute          (WTO is not a funding organization)
  settlement
SPS/TBT Agreements
General Principles
 Sovereignty                       SPS AGREEMENT
 Harmonization        Article 10: Special and Differential Treatment
 Equivalence
 Scientific basis     Members are to consider needs of
 Transparency         other Member countries
 Technical            Time limit exception (granted by SPS
  Assistance           Committee upon request)
 Special and
  differential
                       Longer time frames for compliance with
  treatment
                       this agreement
 Consultation and     Developing countries should actively
  dispute settlement   participate in international organizations
SPS/TBT Agreements
General Principles                   SPS AGREEMENT
 Sovereignty                           Article 11
 Harmonization
                             Consultations and Dispute Settlement
 Equivalence
 Scientific basis


  Transparency
  Technical
                     Rules established by GATT (Article XXII
  Assistance         and XXIII)
 Special and
  differential
                     Technical/Scientific - advise from experts,
  treatment
                     advisory panels or relevant international
 Consultation       organizations
  and dispute
  settlement
                      Other existing international agreements
                     may be used
    SPS/TBT Agreements
    General Principles SPS AGREEMENT
                                         Article 11
 Sovereignty
 Harmonization                      Administration
 Equivalence             The SPS Committee was established to


  Scientific basis
  Transparency
                      encourage the use of International
                     Standards
 Technical
  Assistance
                      maintain contact with international
                     organizations
 Special and
  differential        develop procedures to monitor
  treatment          harmonization
 Consultation        monitor for duplication of procedures
  and dispute
  settlement         examine specific standards
                      review operational procedures after3 years
    SPS/TBT Agreements
    General Principles            TBT AGREEMENT
 Sovereignty                    The Committee on TBT
 Harmonization
                     Meets as necessary, at least once a year


  Equivalence
  Scientific basis
                     To enable members to consult on the
  Transparency       operations of the agreement

 Technical          Committee can establish working
  Assistance         parties or other bodies as appropriate
 Special and        Committee to ensure duplication with
  differential
  treatment          other technical bodies is prevented
 Consultation and
  dispute
  settlement
Achievements and Challenges

   Harmonization
   Equivalence
   Scientific basis
   Special and differential
    treatment/Technical assistance
  Achievements and Challenges
 Harmonization             Achievements:
                       HACCP-based systems
 Equivalence        widely accepted

 Scientific basis
                       Codex Alimentarius
                     Commission accepted as the
                     international standards setting
 Special and
                     body
  differential                Shortcomings:
  treatment/
   Technical
                      Different inspection and control
                       schemes
  assistance
                      Different fish standards applied
                      High rates of detentions/rejections
  Achievements and Challenges
 Harmonization
                              Achievements:
 Equivalence
                   “Food chain” and “Control at source”
                  approaches
 Scientific       Cost-effectiveness of these approaches
  basis

 Special and                    Shortcomings:
  differential     Very few agreements
  treatment/       Obligation of means vs. obligation of results
   Technical
  assistance
 Achievements and Challenges
 Harmonization             Achievements:

 Equivalence     Risk analysis widely accepted
                  National and International
 Scientific      work undertaken
  basis
                              Shortcomings:
 Special and     Needs exceed by far activities undertaken
  differential    Lack of resources in developing countries
  treatment/
   Technical
                  Many standards not scientifically based
  assistance
  Achievements and Challenges
 Harmonization                 Achievements:
                      Regional and national initiatives (SIDA,
 Equivalence         EC-ACP)
                      STDF (Standard and Trade
 Scientific basis    Development Fund)
                      Trust Fund for CAC
 Special and                       Shortcomings:
  differential
  treatment/
                      Developing countries obliged to meet market
                       requirements
   Technical
                      Needs exceed by far initiatives
  assistance
                      Lack of resources in developing countries
                      Many standards not scientifically based
                            Risk Analysis



 Risk Assessment        Risk Management           Risk Communication




Hazard identification    Hazard                   Exposure assessment
                         characterisation


                          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:             Chemical hazards:
Usually acute effect              • Usually cumulative effect
• Single exposure                  • Multiple exposures
• Pathogen/commodity               • One chemical - many foods
  combination                      • Toxic levels stable or decrease
• Living hazards - numbers can       during storage
  change up or down                • Processing has minimal effect
• Dynamic and adaptable -          • Acceptable levels defined for
  different characteristics &        many chemical hazards
  variable response
• Difficult to define acceptable
  levels
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                           Exposure
   characterization                    assessment


                     Risk
                characterization
             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
Initial number - Poisson
                           0.4
     Fraction of samples

                           0.3

                           0.2

                           0.1

                           0.0
                                 0    1   2   3   4   5   6   7
                                     Number of Microbes
Growth rate is normal
                 0.14
                 0.12
                 0.10
     Frequency



                 0.08
                 0.06
                 0.04
                 0.02
                 0.00
                        15   20   25   30   35   40   45
                              Doubling Time (hr)
Simulation Results
                 0.4

                 0.3
     Frequency


                 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 dose-
 response 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                  Infrastructure
  • Experts                       • Epidemiology
                                  • Food consumption
                                  • Outbreak
Tools
                                    investigation
  • Statistics
                                  • Consumer
  • Ranking                         behaviour
  • Simulation (e.g. Monte
                               Framework
    Carlo)
                                  • Risk analysis
  • Knowledge elicitation
Iterative process of MRA
 Collect data
 Define assumptions
 Develop model

                             Revise model
 Run simulation

 Review results               YES

 Need more data?
 Assumptions not suitable?
       NO
 Estimate risk

 Validate
   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   Mean annual illness
3/g                      0.16
30/g                     1.2
300/g                    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      Risk assessment of Vibrio
 3      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                            Water salinity
temperature



                   Total Vp/g




                Pathogenic
                Vp/g


HARVEST MODULE OF RA MODEL
                    Time to
    Vp/g at         refrigeration
    harvest

                   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
                              Jan-    Apr-     Jul-  Oct-
                              Mar      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 1997-
                                               2002 from oysters;
                                               several outbreaks
Orongo                                         from other seafood
Bay               0         15          0      sources
Hiroshima                                      13 during 1998-
Bay              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
THANK YOU

								
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