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ESTABLISHING PRODUCT STANDARDS AND CERTIFICATION SYSTEMS Iddya Karunasagar Fish Utilisation and Marketing Service FAO, Rome.

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Presentation on theme: "ESTABLISHING PRODUCT STANDARDS AND CERTIFICATION SYSTEMS Iddya Karunasagar Fish Utilisation and Marketing Service FAO, Rome."— Presentation transcript:

1 ESTABLISHING PRODUCT STANDARDS AND CERTIFICATION SYSTEMS Iddya Karunasagar Fish Utilisation and Marketing Service FAO, Rome

2 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

3 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

4 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

5 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

6 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

7 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)

8 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

9 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

10 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

11 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.

12 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

13 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

14 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

15 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

16 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.

17 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.

18 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.

19 Implications of the SPS and TBT agreements in Fisheries

20 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalency Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement

21 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement Each country is sovereign to establish SPS measures it terms necessary to protect human and animal health and plants SPS Annex A SPS AGREEMENT Annex A Definitions Definitions Appropriate Level of Protection The level of protection deemed appropriate by the Member to protect human, animal or plant life or health “Acceptable Level of Risk”

22 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement  Prohibits discriminatory, disguised or unnecessary restrictive trade measures 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

23 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement  or for the prevention of deceptive practices, at the levels considered appropriate 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

24 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement SPS AGREEMENT Annex A Definitions Harmonization Establishment, Recognition and Application of Common Sanitary/Phytosanitary Measures by Members

25 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement SPS AGREEMENT Annex A SPS AGREEMENT Annex A Definitions: Harmonization Codex Alimentarius Commission  Codes /Guidelines of Hygienic Practices Standards, Guidelines, and Recommendations for Food Safety  Food Additives  Veterinary Drug and Pesticide Residues  Contaminants  Methods of Analysis and Sampling

26 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement SPS AGREEMENT Annex A Definitions: Harmonization International Plant Protection Convention  Standards, Guidelines, and Recommendations for Plant Health International Plant Protection Convention  Standards, Guidelines, and Recommendations for Animal Health and Zoonoses International Office of Epizootic

27 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement 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

28 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement SPS AGREEMENT Article 3 Harmonization  Higher level of protection may be used  Members shall base Sanitary and Phytosanitary Measures on international standards, guidelines and recommendations  Measures which conform to international standards are consistent with Agreement

29 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement SPS AGREEMENT Article 3 Harmonization  WTO to monitor progress of international harmonization  Members are to fully participate in relevant international organizations

30 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement SPS AGREEMENT Article 4 Equivalence  Members shall consult to achieve bilateral and multilateral agreement (Mutual Recognition Agreements)  Members shall accept other Member measures as equivalent, if final results are the same

31 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement SPS AGREEMENT Article 5 Risk Assessment SPS Measures are to be based on an assessment of the risks to Human, Animal and Plant life and health using internationally accepted Risk Assessment Techniques Risk Assessment should take into account  available scientific evidence  relevant processes and production methods  inspection/sampling/testing methods  prevalence of specific diseases or pests  existence of pest/disease free areas  ecological/environmental conditions  quarantine or other treatment

32 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement SPS AGREEMENT Article 5: Risk Assessment  Explanations may be requested by Members  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

33 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement 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)

34 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement Bypass publication Immediately notify Members through SPS Committee Secretariat Allow Members to comment and take comments into account SPS AGREEMENT Article 7 Transparency Emergency circumstances

35 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement SPS AGREEMENT Article 7 Transparency Notification Procedures  Allow Members to comment and take comments into account  Prompt publication  Provide information on effected products, objectives and rational  Provide copies of regulation on request

36 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement SPS AGREEMENT Article 9 Technical Assistance  If substantial investment is needed, technical assistance should be provided  Members agree to facilitate technical assistance, especially to developing countries (WTO is not a funding organization)

37 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement SPS AGREEMENT Article 10: Special and Differential Treatment  Developing countries should actively participate in international organizations  Members are to consider needs of other Member countries  Longer time frames for compliance with this agreement  Time limit exception (granted by SPS Committee upon request)

38 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement SPS Article 11 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

39 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement  review operational procedures after3 years SPS Article 11 SPS AGREEMENT 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

40 SPS/TBT Agreements General Principles Sovereignty Harmonization Equivalence Scientific basis Transparency Technical Assistance Special and differential treatment Consultation and dispute settlement 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

41 Achievements and Challenges Harmonization Equivalence Scientific basis Special and differential treatment/Technical assistance

42 Achievements and Challenges Harmonization Equivalence Scientific basis Special and differential treatment/ Technical assistance Shortcomings:  Different inspection and control schemes  Different fish standards applied  High rates of detentions/rejections Achievements:  HACCP-based systems widely accepted  Codex Alimentarius Commission accepted as the international standards setting body

43 Achievements and Challenges Harmonization Equivalence Scientific basis Special and differential treatment/ Technical assistance Shortcomings:  Very few agreements  Obligation of means vs. obligation of results Achievements:  “Food chain” and “Control at source” approaches  Cost-effectiveness of these approaches

44 Achievements and Challenges Harmonization Equivalence Scientific basis Special and differential treatment/ Technical assistance Shortcomings:  Needs exceed by far activities undertaken  Lack of resources in developing countries  Many standards not scientifically based Achievements:  National and International work undertaken  Risk analysis widely accepted

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

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48 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

49 '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;

50 '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;

51 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

52 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

53 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

54 RISK ASSESSMENT AREAS Microbiological Chemical Biotechnological

55 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

56 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

57 Risk Assessment - Codex Hazard identification Exposure assessment Hazard characterization Risk characterization

58 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

59 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”

60 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

61 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

62 Initial number - Poisson

63 Growth rate is normal

64 Simulation Results

65 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

66 Dose response curve

67 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

68 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.

69 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”

70 Exposure Analysis Estimate  likelihood of consumption  likely number (dose) of the pathogen If “quantitative” assessment  Modeling  Simulation

71 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

72 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

73 Iterative process of MRA Run simulation Review results Need more data? Assumptions not suitable? Revise model Estimate risk Validate YES NO Collect data Define assumptions Develop model

74 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

75 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

76 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

77 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

78 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)

79 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 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 Outcomes of MRAs

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83 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

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85 Regional, seasonal and yearly variation Water temperature Water salinity Total Vp/g Pathogenic Vp/g HARVEST MODULE OF RA MODEL

86 Vp/g at harvest Vp/g at first refrigeration Time to refrigeration Air temperature Vp/g at cool down Vp/g at consumption Cool down time Storage time POST HARVEST MODULE OF RA MODEL

87 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

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90 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)

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93 THANK YOU


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