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WTOSlide 1 The SPS Agreement and its provisions relating to scientific evidence.

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Presentation on theme: "WTOSlide 1 The SPS Agreement and its provisions relating to scientific evidence."— Presentation transcript:

1 WTOSlide 1 The SPS Agreement and its provisions relating to scientific evidence

2 WTOSlide 2 Three SPS Disputes Hormones EC - Measures Concerning Meat and Meat Products (Hormones) Salmon Australia - Measures Affecting Importation of Salmon Varietals Japan - Measures Affecting Agricultural Products

3 WTOSlide 3 science Basic Rights and Obligations (Article 2) Intl org. (Article 12:3) Harmonization (Article 3) Risk Assessment (Article 5) Expert advice (Article 11:2)

4 WTOSlide 4 Article 2.1 Members have the right to take sanitary and phytosanitary measures necessary for the protection of human, animal or plant life or health, provided that such measures are not inconsistent with the provisions of this Agreement Basic Rights and Obligations (Article 2)

5 WTOSlide 5 Article 2.2 Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence, except as provided for in paragraph 7 of Article 5. Basic Rights and Obligations (Article 2)

6 WTOSlide 6 Article 2.2 shall ensure: Basic Rights and Obligations applied only to the extent necessary to protect human, animal or plant life or health is based on scientific principles is not maintained without sufficient scientific evidence except as provided for in paragraph 7 of Article 5.

7 WTOSlide 7 focus on risk assessment (Article 5) HormonesSalmonVarietals Article 2:2 (Basic Rights and Obligations)

8 WTOSlide 8 In our view, for a phytosanitary measure to be maintained without sufficient scientific evidence, there needs to be a lack of an objective relationship between, on the one hand, the phytosanitary measure at stake (in casu, the varietal testing requirement) and, on the other hand, the scientific evidence submitted before the Panel (in casu, in particular the six studies referred to by Japan). Japan -Varietals, Panel Report, para. 8.29. Panel - Varietals Article 2:2 (Basic Rights and Obligations)

9 WTOSlide 9 The Panel reviewed the parties submissions and the advice from the scientific experts (entomology, fumigation) and concluded: it has not been sufficiently demonstrated that there is a rational relationship between the varietal testing requirement and the scientific evidence submitted to the Panel Japan -Varietals, Panel Report, para. 8.42 Panel - Varietals Article 2:2 (Basic Rights and Obligations)

10 WTOSlide 10 Article 2.2 shall ensure: Basic Rights and Obligations applied only to the extent necessary to protect human, animal or plant life or health is based on scientific principles is not maintained without sufficient scientific evidence except as provided for in paragraph 7 of Article 5

11 WTOSlide 11 Article 2:2 (Basic Rights and Obligations) Panel - Varietals lack of an objective relationship measure the scientific evidence submitted before the Panel Article 2.2 (?)

12 WTOSlide 12 AB - Varietals Upheld. (with respect to apples, cherries, nectarines and walnuts) Japan -Varietals, AB, para. 85. Article 2:2 (Basic Rights and Obligations)

13 WTOSlide 13 What about the exception to the rule of basing SPS measures on science? (Article 5.7) Article 2.2Article 5.7 Article 5.7 operates as a qualified exemption from the obligation under Article 2.2 to maintain SPS measures without sufficient scientific evidence. Varietals, AB Report, para. 80

14 WTOSlide 14 Article 2.2 shall ensure: Basic Rights and Obligations applied only to the extent necessary to protect human, animal or plant life or health is based on scientific principles is not maintained without sufficient scientific evidence except as provided for in paragraph 7 of Article 5

15 WTOSlide 15 Where scientific evidence is insufficient (Article 5.7) SPS Agreement, Article 5.7 In cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time.

16 WTOSlide 16 Article 5:7 qualified exemption Japan specifically invoked 5:7. It claimed that that its measure could be considered a provisional measure The Panel found that four cumulative elements needed to be shown for a measure to be consistent with Article 5.7. Panel - Varietals

17 WTOSlide 17 Article 5:7 qualified exemption Panel - Varietals the measure is imposed in respect of a situation where relevant scientific information is insufficient; the measure is adopted on the basis of available pertinent information Allowed to provisionally adopt a measure if: 1 2 and

18 WTOSlide 18 Article 5:7 qualified exemption Panel - Varietals seek to obtain the additional information necessary for a more objective assessment of risk; and, review the … phytosanitary measure accordingly within a reasonable period of time. + additional obligations: 3 4 and

19 WTOSlide 19 Article 5:7 qualified exemption Panel - Varietals Panel examined only the third and fourth elements –no evidence that Japan had sought to obtain information necessary for a more objective assessment of the risk… –... and reviewed the measure accordingly within a reasonable period of time ……. Article 5.7 Article 2.2

20 WTOSlide 20 AB - Varietals Article 5:7 qualified exemption Upheld. –Confirmed that four requirements are cumulative –Agreed with the Panel that Japan had not sought to obtain additional information –Noted that the reasonable period of time had to be established on a case-by-case basis

21 WTOSlide 21 Article 5:7 qualified exemption The EC did not invoke Article 5.7, it was explicitly stated that the import prohibition was not a provisional measure. The EC invoked the precautionary principle as a general principle of law and argued that Articles 5.1 and 5.2 did not prevent Members from being cautious when setting health standards in the face of conflicting scientific evidence and uncertainty. Panel - Hormones

22 WTOSlide 22 Article 5:7 qualified exemption Did not take a position on the status of the precautionary principle in international law. Noted that the precautionary principle found reflection in Article 5.7 of the SPS Agreement. Agreed with the finding of the Panel that the precautionary principle - to the extent it is not explicitly incorporated in Article 5.7 - did not override the provisions of Article 5.1 and 5.2 of the SPS Agreement. AB - Hormones

23 WTOSlide 23 Article 5 - Risk AssessmentAssessment of Risk and Determination of the Appropriate Level of Sanitary or Phytosanitary Protection Article 5.1-5.3 risk assessment Article 5.5 consistency Article 5 Article 5.7 insufficient scientific... Article 2.2

24 WTOSlide 24 Risk Assessment (Article 5.1 - 5.3) Article 5.1 Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations.

25 WTOSlide 25 Risk Assessment (Article 5.1 - 5.3) Article 5.2 In the assessment of risks, Members shall take into account available scientific evidence; relevant processes and production methods; relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of pest- or disease-free areas; relevant ecological and environmental conditions; and quarantine or other treatment

26 WTOSlide 26 Risk Assessment (Article 5.1 - 5.3) Article 5.3 In assessing the risk to animal or plant life or health and determining the measure to be applied for achieving the appropriate level of sanitary or phytosanitary protection from such risk, Members shall take into account as relevant economic factors: the potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or disease; the costs of control or eradication in the territory of the importing Member; and the relative cost-effectiveness of alternative approaches to limiting risks.

27 WTOSlide 27 Risk Assessment (Article 5.1 - 5.3) Article 5.1 Article 5.2 Article 5.3 measure has to be based on a risk assessment what to take into account (available scientific evidence, etc.) for animal and plant health, what economic factors to take into account

28 WTOSlide 28 HormonesSalmonVarietals Article 5.1-5.3 risk assessment Focus on 2.2 scientific evidence food safety (5.1-5.2) animal health (5.1-5.3)

29 WTOSlide 29 Article 5.1-5.2 risk assessment The definition of a risk assessment for food-borne risks "the evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs". –SPS Agreement, Annex A, Paragraph 4, second sentence Panel - Hormones

30 WTOSlide 30 Article 5.1-5.2 risk assessment Panel - Hormones identify the adverse effects on human health (if any) arising from the presence of the hormones at issue when used as growth promoters in meat or meat products, and if any such adverse effect exists, evaluate the potential or probability of occurrence of these effects 1 2

31 WTOSlide 31 Article 5.1-5.2 risk assessment Panel - Hormones Existence of a risk assessment? –The EC had invoked several scientific reports that the experts advising the Panel considered to be risk assessments –For five of the hormones, the Panel assumed that the EC had demonstrated the existence of a risk assessment.

32 WTOSlide 32 Article 5.1-5.2 risk assessment Panel - Hormones However, the Panel found that the EC measure was not based on the scientific evidence submitted.

33 WTOSlide 33 Article 5.1-5.2 risk assessment Panel - Hormones In our view, the scientific conclusion reflected in the EC measures in dispute, i.e., that the use of the hormones in dispute for growth promotion purposes, even in accordance with good practice, is not safe, does not conform to any of the scientific conclusions reached in the evidence referred to by the European Communities.... EC-Hormones, Panel Report, para. 8.137

34 WTOSlide 34 Article 5.1-5.2 risk assessment Panel - Hormones The EC import ban of meat and meat products from animals treated with any of the five hormones at issue for growth promotion purposes, allegedly necessary to protect human health, in so far as it also applies to meat and meat products from animals treated with any of these hormones in accordance with good practice, is, therefore, not based on the scientific evidence submitted to the Panel. EC-Hormones, Panel Report, para. 8.137

35 WTOSlide 35 Panel - Hormones Article 5.1-5.2 risk assessment compared to scientific conclusions reached in each of the studies the scientific conclusion reflected in the measure Article 2.2 lack of an objective relationship measure the scientific evidence before the Panel Article 5.1

36 WTOSlide 36 AB - Hormones Upheld finding on 5.1. –lack of a rational relationship between measure and science other points: –Article 5.2 not a closed list (risk related to control and other non-scientific factors could be considered) –Article 5.1 is not prescriptive on who does the risk assessment. Article 5.1-5.2 risk assessment

37 WTOSlide 37 HormonesSalmonVarietals Article 5.1-5.3 risk assessment Article 2 food safety (5.1-5.2) animal health (5.1-5.3)

38 WTOSlide 38 Article 5.1-5.2 risk assessment The definition of a risk assessment for pest or disease-borne risk "the evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the sanitary or phytosanitary measure which might be applied, and of the associated potential biological and economic consequences". –SPS Agreement, Annex A, Paragraph 4, first sentence Panel - Salmon

39 WTOSlide 39 The difference between the two definitions: –Food borne: evaluation of the potential for adverse effects on human or animal health –Disease or pest risk: an evaluation of the likelihood of entry, establishment or spread of a disease, and the associated potential biological and economic consequences Risk Assessment (Annex A - Definition)

40 WTOSlide 40 Article 5.1-5.2 risk assessment Panel - Salmon identify the disease(s) whose entry, establishment or spread within its territory it wants to prevent as well as the associated potential biological and economic consequences evaluate the likelihood of entry, establishment or spread of these diseases, as well as the associated potential biological and economic consequences; and, evaluate the likelihood of entry, establishment and spread of these diseases according to the SPS measure which might be applied 2 1 3

41 WTOSlide 41 Consistent –24 diseases identified... No finding - assumed consistent –some elements of both possibility and probability –nevertheless surprised that Australia had not used a previous risk assessment No finding - assumed consistent –evaluates to some extent a series of risk reduction factors (five quarantine options) Article 5.1-5.2 risk assessment Panel - Salmon identify evaluate the likelihood of entry … according to the SPS measure … = no violation of Article 5.1 1 2 3

42 WTOSlide 42 Article 5.1-5.2 risk assessment identify evaluate the likelihood of entry … according to the SPS measure … Consistent (agreed with Panel) Requirement not met (disagreed) –some evaluation of likelihood was not enough –referred to experts opinions that had agreed that an evaluation and expression of probability or likelihood, either quantitative or qualitative was crucial to a risk assessment. Requirement not met (disagreed) –some evaluation was not enough Article 5.1 Article 2.2 AB - Salmon 1 2 3

43 WTOSlide 43 HormonesSalmonVarietals summary so far Scientific evidence (Article 2.2) Risk Assessment (Article 5.1-5.2) Rational relationship between the measure and the science The approach to a risk assessment: –food-borne: identify / evaluate potential –disease- or pest borne: identify / evaluate likelihood / according to measure applied

44 WTOSlide 44 Article 5 - Risk AssessmentAssessment of Risk and Determination of the Appropriate Level of Sanitary or Phytosanitary Protection Article 5.1-5.3 risk assessment Article 5.5 consistency Article 5 Article 5.7 insufficient scientific... Article 2.2

45 WTOSlide 45 consistency (Article 5.5) With the objective of achieving consistency in the application of the concept of appropriate level of sanitary or phytosanitary protection against risks to human life or health, or to animal and plant life or health, each Member shall avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade. Members shall cooperate in the Committee, in accordance with paragraphs 1, 2 and 3 of Article 12, to develop guidelines to further the practical implementation of this provision. In developing the guidelines, the Committee shall take into account all relevant factors, including the exceptional character of human health risks to which people voluntarily expose themselves

46 WTOSlide 46 With the objective of achieving consistency in the application of the concept of appropriate level of sanitary or phytosanitary protection against risks to human life or health, or to animal and plant life or health, each Member shall avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade. consistency (Article 5.5)

47 WTOSlide 47 HormonesSalmon(Varietals) Not an issue Three pronged test consistency (Article 5.5) Q1 Q2 Q3

48 WTOSlide 48 Are the situations comparable? Are there different levels of protection? consistency (Article 5.5) Q1 Do the differences result in discrimination or a disguised restriction on international trade? Q3 PanelAB Are the differences in levels of protection arbitrary or unjustifiable? Q2

49 WTOSlide 49 Article 5.5 - consistency Panel - Hormones SITUATIONS 1 Different treatment for: administered natural hormones for growth promotion compared to (i) those occurring endogenously in meat and other foods; …. 2 Different treatment for: synthetic hormones for growth promotion compared to natural hormones occurring endogenously in meat and other foods 3 Different treatment for: hormones used for growth-promotions purposes and carbadox (anti-microbial growth-promoter used as a feed additive in swine production)

50 WTOSlide 50 1 SITUATION Comparable? (Yes) –Yes. Same potential adverse health effect (carcinogenicity) Different levels of protection? (Yes) –Yes. No residue allowed level as opposed to unlimited residue level. Different treatment for: administered natural hormones for growth promotion compared to those occurring endogenously in meat and other foods Q1 Q2Q3

51 WTOSlide 51 Q1Q3 Q2 1 SITUATION Are the differences in levels of protection arbitrary or unjustifiable? (Yes.) –The potential for adverse effects are the same (either for administered or endogenous). –The total residue level of natural hormones in meat from treated animals falls well within the physiological range of levels found in meat from untreated animals, which levels vary according to sex and age of the animal –The residue level of natural hormones in many natural products (such as eggs and soya oil) is much higher than the level of residues of these hormones administered for growth promotion - as well as the total residue level of these hormones - in treated meat –Significant difference in levels of protection AB: Reversed Different treatment for: administered natural hormones for growth promotion compared to (i) those occurring endogenously in meat and other foods;

52 WTOSlide 52 Q1Q3 Q2 1 Different treatment for: administered natural hormones for growth promotion compared to (i) those occurring endogenously in meat and other foods; SITUATION We do not share the Panel's conclusions that the above differences in levels of protection in respect of added hormones in treated meat and in respect of naturally- occurring hormones in food, are merely arbitrary and unjustifiable. To the contrary, we consider there is a fundamental distinction between added hormones (natural or synthetic) and naturally-occurring hormones in meat and other foods. –Hormones, AB Report, para. 221. AB: Reversed

53 WTOSlide 53 Article 5.5 - consistency Panel - Hormones SITUATIONS 1 Different treatment for: administered natural hormones for growth promotion compared to (i) those occurring endogenously in meat and other foods; (ii) those used for therapeutic or zootechnical purposes 2 Different treatment for: synthetic hormones for growth promotion compared to natural hormones occurring endogenously in meat and other foods 3 Different treatment for: hormones used for growth-promotions purposes and carbadox (anti-microbial growth-promoter used as a feed additive in swine production)

54 WTOSlide 54 2 Different treatment for: synthetic hormones for growth promotion compared to natural hormones occurring endogenously in meat and other foods Q2 Are the differences in levels of protection arbitrary or unjustifiable? (Yes.) –Panel found that there was no evidence that synthetic hormones were inherently more dangerous than natural hormones, or that they were unsafe. –No justification for a significant difference in levels of protection. AB: Reversed Q1Q3

55 WTOSlide 55 Article 5.5 - consistency Panel - Hormones SITUATIONS 1 Different treatment for: administered natural hormones for growth promotion compared to (i) those occurring endogenously in meat and other foods; (ii) those used for therapeutic or zootechnical purposes 2 Different treatment for: synthetic hormones for growth promotion compared to natural hormones occurring endogenously in meat and other foods 3 Different treatment for: hormones used for growth-promotion purposes and carbadox (anti-microbial growth-promoter used as a feed additive in swine production)

56 WTOSlide 56 3 Different treatment for: hormones used for growth- promotions purposes and carbadox (anti-microbial growth-promoter used as a feed additive in swine production) Q3 Do the differences result in discrimination or a disguised restriction on international trade? (Yes.) –significant difference in levels of protection –no plausible justification for this difference –leads to an import ban –+ objectives other than health (reducing beef surplus) –+ the ban on administered hormones favoured consumption of domestic meat over US meat –EU pork meat sector is without surpluses - competitiveness a higher priority Q1Q2 AB: Reversed

57 WTOSlide 57 We are unable to share the inference that the Panel apparently draws that the import ban on treated meat and the Community-wide prohibition of the use of the hormones here in dispute for growth promotion purposes in the beef sector were not really designed to protect its population from the risk of cancer, but rather to keep out US and Canadian hormone-treated beef and thereby to protect the domestic beef producers in the European Communities. –Hormones, AB Report, para. 245. AB: Reversed 3 Different treatment for: hormones used for growth- promotions purposes and carbadox (anti-microbial growth-promoter used as a feed additive in swine production) Q3 Q1Q2

58 WTOSlide 58 consistency (Article 5.5) - summary - Q1Q3Q2 1 2 3 Violation of 5:5 AB: Reversed

59 WTOSlide 59 SITUATION Comparable? (Yes) –In both situations there is at least one common disease of concern –The consequences associated with disease can be presumed to be at least similar (pest- or disease-borne risk) Different levels of protection? (Yes) –Salmon is effectively prohibited. Other aquatic animals allowed in (without control for bait, and with control for ornamental finfish) Canadian adult, wild ocean-caught salmon for human consumption is restricted while, on the other hand, whole frozen herring for use as bait and live ornamental finfish are allowed access. Q1 Q2 Q3 AB: Upheld 3&4

60 WTOSlide 60 Q1 Q3 Q2 SITUATION Are the differences in levels of protection arbitrary or unjustifiable? (Yes.) –Panel argued that since the level of protection for salmon is higher, one would expect a higher risk for salmon than for the other fish. Yet the evidence was to the contrary. –Canada had raised a presumption that bait / ornamental fish posed a higher risk which Australia had not rebutted. Canadian adult, wild ocean-caught salmon for human consumption is restricted while, on the other hand, whole frozen herring for use as bait and live ornamental finfish are allowed access. AB: Upheld 3&4

61 WTOSlide 61 Q1 Q3 Q2 SITUATION 1st warning signal 2nd warning signal 3rd warning signal 1st additional factor 2nd additional factor 3rd additional factor Canadian adult, wild ocean-caught salmon for human consumption is restricted while, on the other hand, whole frozen herring for use as bait and live ornamental finfish are allowed access. Article 5:5 3&4

62 WTOSlide 62 Q3 SITUATION Arbitrary character in the differences in the levels of protection (bait/ornamental finfish can be presumed to represent a higher risk) Substantial differences in levels of protection. –AB: emphasis on the degree of difference Violation of Article 5.1 and 2.2 –AB: non-existence of a risk assessment a strong indication that the measure was not really concerned with the protection of health Same measure to products which can be presumed to represent the same risk –AB reversed: Same as first warning signal. Lack of sufficient (scientific) explanation for the change in conclusions between the 1995 Draft Report and the 1996 Final Report - inspired by domestic pressures to protect Australian salmon industry Internal movement restrictions not as severe –AB: Panels doubts do not carry much wait but can be taken into consideration 3&4

63 WTOSlide 63 Q1 Q3 Q2 SITUATION 1st warning signal 2nd warning signal 3rd warning signal 1st additional factor 2nd additional factor 3rd additional factor Canadian adult, wild ocean-caught salmon for human consumption is restricted while, on the other hand, whole frozen herring for use as bait and live ornamental finfish are allowed access. 3&4 Article 5:5 AB: Upheld

64 WTOSlide 64 consistency (Article 5.5) - summary - Q1Q3Q2 Violation of 5:5 3&4

65 WTOSlide 65 consistency (Article 5.5) key points Both the Panel and the AB used the same three pronged test to show a violation of Article 5.5. Comparable situations, a broad concept Separate requirement of discrimination Do the differences result in discrimination or a disguised restriction on international trade? Q3

66 WTOSlide 66 Article 3.1 To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in this Agreement, and in particular in paragraph 3 Harmonization (Article 3)

67 WTOSlide 67 "the relevant international organizations" food safety CODEX plant health IPPC animal health OIE Harmonization (Article 3)

68 WTOSlide 68 Article 3.3 Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5. 3 Notwithstanding the above, all measures which result in a level of sanitary or phytosanitary protection different from that which would be achieved by measures based on international standards, guidelines or recommendations shall not be inconsistent with any other provision of this Agreement. Harmonization (Article 3)

69 WTOSlide 69 Harmonization (Article 3) Article 3.3 … higher level … if... there is a scientific justification as a consequence of the level of sanitary or phytosanitary protection a Member determines to be appropriate... or Notwithstanding shall not be inconsistent with any other provision of this Agreement

70 WTOSlide 70 Article 3.2 Sanitary or phytosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994. Harmonization (Article 3)

71 WTOSlide 71 Harmonization (Article 3) Article 3.1Article 3.2Article 3.3 shall base... conform to... consistent higher level HormonesSalmonVarietals no claims started with Article 5 and then found that there was no need to go further

72 WTOSlide 72 Harmonization (Article 3) Article 3.1Article 3.2Article 3.3 shall base... measures on international standards conform to... consistent higher level Does an international standard exist? Yes, for five. –Three natural hormones (unnecessary to establish ADI or MRL) –Two synthetic: Codex Standards apply.

73 WTOSlide 73 Harmonization (Article 3) Article 3.1Article 3.2Article 3.3 shall base... measures on international standards conform to... consistent higher level What is the meaning of based on? –The Panel equated based on with conform to. For a measure to be based on and international standard, it needed to be reflect the same level of sanitary protection as the standard. AB: Disagreed

74 WTOSlide 74 Under Article 3.1 of the SPS Agreement, a Member may choose to establish an SPS measure that is based on the existing relevant international standard, guideline or recommendation. Such a measure may adopt some, not necessarily all, of the elements of the international standard. The Member imposing this measure does not benefit from the presumption of consistency set up in Article 3.2 EC-Hormones, AB Report, para. 171 Harmonization (Article 3) AB - Hormones

75 WTOSlide 75 Harmonization (Article 3) Article 3.1Article 3.2Article 3.3 shall base... measures on international standards conform to... consistent higher level Is the EC measure based on the international standard? (No). –The level of protection is significantly different (higher) than for Codex standards for both the natural and the synthetic hormones.

76 WTOSlide 76 Harmonization (Article 3) Article 3.1Article 3.2Article 3.3 shall base... measures on international standards conform to... consistent higher level When can Article 3.3 be invoked? –Two conditions (either or) –Regardless of the two conditions, the measure nevertheless has to comply with the other conditions of the SPS Agreement. Is there a violation? –Measure can only be justified under Article 3.3 if the measure meets, inter alia, the requirements imposed by Article 5. Examine Article 5 first.

77 WTOSlide 77 Harmonization (Article 3) Article 3.1Article 3.2Article 3.3 shall base... measures on international standards conform to... consistent higher level Agreed with the Panels finding that EC is required by Article 3.3 to comply with the requirements of Article 5.1. Stressed that the right of a Member to determine its own appropriate level of protection is an important right Stated that the right of a Member to establish its own level of protection under Article 3.3 is an autonomous right and not an exception from a general obligation under Article 3.1. AB: Agreed with Panels conclusion

78 WTOSlide 78 Some key issues Rational or objective relationship between the measure and the science Approach by Panel and AB to risk assessment (food-borne and pest- or disease- borne risk) The use of precaution in situations where there is insufficient scientific evidence (5.7) Approach by Panel and AB when showing for discrimination (5:5)

79 WTOSlide 79 Internet: www.wto.org Hormones (two) EC Measures Concerning Meat and Meat Products (Hormones) WT/DS26 and 48/... Salmon Australia - Measures Affecting Importation of Salmon WT/DS18/... Varietals Japan - Measures Affecting Agricultural Products WT/DS76/...

80 WTOSlide 80 The SPS Agreement and its provisions relating to scientific evidence


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