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The SPS Agreement and its provisions relating to scientific evidence

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

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The SPS Agreement and its provisions relating to scientific evidence

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  1. The SPS Agreementand its provisions relating toscientific evidence Slide 1

  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 Slide 2

  3. Basic Rights andObligations (Article 2) Harmonization (Article 3) Int’l org.(Article 12:3) Risk Assessment(Article 5) Expert advice(Article 11:2) “science” Slide 3

  4. Basic Rights and Obligations(Article 2) 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” Slide 4

  5. Basic Rights and Obligations(Article 2) 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.” Slide 5

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

  7. focus on risk assessment (Article 5) Article 2:2(Basic Rights and Obligations) Hormones Salmon Varietals Slide 7

  8. Article 2:2(Basic Rights and Obligations) Panel - Varietals “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. Slide 8

  9. Article 2:2(Basic Rights and Obligations) Panel - Varietals 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 Slide 9

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

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

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

  13. What about the exception to the rule of basing SPS measures on science? (Article 5.7) Article 2.2 Article 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 Slide 13

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

  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.” Slide 15

  16. Article 5:7“qualified exemption” Panel - Varietals • 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. Slide 16

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

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

  19. ……. ……. ……. …….  Article 5.7  Article 2.2 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 Slide 19

  20. Article 5:7“qualified exemption” AB - Varietals • 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 Slide 20

  21. Article 5:7“qualified exemption” Panel - Hormones • 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. Slide 21

  22. Article 5:7“qualified exemption” AB - Hormones • 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. Slide 22

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

  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.” Slide 24

  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” Slide 25

  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.” Slide 26

  27. Risk Assessment(Article 5.1 - 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 Article 5.1 Article 5.2 Article 5.3 Slide 27

  28. Focus on 2.2“scientific evidence” food safety (5.1-5.2) animal health(5.1-5.3) Article 5.1-5.3risk assessment Hormones Salmon Varietals Slide 28

  29. Article 5.1-5.2risk assessment Panel - Hormones • "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 The definition of a risk assessment for food-borne risks Slide 29

  30. Article 5.1-5.2risk assessment Panel - Hormones 1 “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 2 “if any such adverse effect exists, evaluate the potential or probability of occurrence of these effects Slide 30

  31. Article 5.1-5.2risk 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. Slide 31

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

  33. Article 5.1-5.2risk 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 Slide 33

  34. Article 5.1-5.2risk 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 Slide 34

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

  36. Article 5.1-5.2risk assessment 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. Slide 36

  37. Article 2 food safety (5.1-5.2) animal health(5.1-5.3) Article 5.1-5.3risk assessment Hormones Salmon Varietals Slide 37

  38. Article 5.1-5.2risk assessment Panel - Salmon • "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 The definition of a risk assessment for pest or disease-borne risk Slide 38

  39. Risk Assessment(Annex A - Definition) • 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 Slide 39

  40. Article 5.1-5.2risk 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 1 “evaluate the likelihood of entry, establishment or spread of these diseases, as well as the associated potential biological and economic consequences; and, 2 “evaluate the likelihood of entry, establishment and spread of these diseases according to the SPS measure which might be applied 3 Slide 40

  41. Article 5.1-5.2risk assessment Panel - Salmon • 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) = no violation of Article 5.1 1 “identify” 2 “evaluate the likelihood of entry 3 “… according to the SPS measure …” Slide 41

  42. Article 5.1-5.2risk assessment AB - Salmon • 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 1 “identify” 2 “evaluate the likelihood of entry 3 “… according to the SPS measure …” Slide 42

  43. summary so far Risk Assessment(Article 5.1-5.2) Risk Assessment(Article 5.1-5.2) Scientific evidence (Article 2.2) • 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 Hormones Salmon Varietals Slide 43

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

  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” Slide 45

  46. “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. Slide 46

  47. “consistency” (Article 5.5) Three pronged test Not an issue Hormones Salmon (Varietals) Q1 Q2 Q3 Slide 47

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

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

  50. SITUATION 1 Different treatment for: administered natural hormones for growth promotion compared to those occurring endogenously in meat and other foods • 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. Q1 Q2 Q3 Slide 50

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