Challenges in implementing the SPS Agreement

1. Challenges in implementing the SPS Agreement Gretchen Stanton Agriculture and Commodities Division

2. Key Provisions of the SPS Agreement • Non-discrimination • Scientific justification • harmonization • risk assessment • consistency • least trade-restrictiveness • Equivalence • Regionalization • Transparency • Technical assistance/special treatment • Control, inspection and approval procedures

4. Non-discrimination Scientific justification harmonization risk assessment consistency least trade-restrictiveness Equivalence Regionalization Transparency Technical assistance/special treatment Control, inspection and approval procedures Whose science? How long? What is justifiable? What ALOP? Key Provisions of the SPS Agreement

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.

6. Article 2.3 • Members shall ensure that their sanitary and phytosanitary measures do not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail, including between their own territory and that of other Members. Sanitary and phytosanitary measures shall not be applied in a manner which would constitute a disguised restriction on international trade.

7. Scientific Justification – Art. 2.2 Sufficient evidence Rational relationship Case-by-case: Measure at issue Quality and quantity of science “... 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)”.

8. Scientific justification – Art. 2.2 “Negligible risk” vs. zero risk Sufficient scientific evidence of ability to establish in natural conditions • The studies did not demonstrate • that latent infection in mature, symptomless apples could occur in real orchard conditions • that apple fruit would be likely to complete the pathway and contaminate host plants in Japan under non-laboratory conditions

9. 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 SPS measure accordingly within a reasonable period of time.

10. Hormones – Precautionary principle • The EC did not invoke Article 5.7 - 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. • Precautionary principle does not override obligation to base measure on risk assessment; precautionary principle reflected in SPS Art.5.7

11. Varietals – Article 5.7 4 Cumulative requirements in order to use Art. 5.7 Members may provisionally adopt SPS measures only • when relevant scientific information is insufficient • on the basis of available information In such circumstances, Members must • seek to obtain additional information to assess risk • review the measure within a reasonable period of time

12. Varietals – Article 5.7 Measure not justified as provisional measure under Art. 5.7 • Japan did not actively seek more scientific evidence in order to do risk assessment • Did not revise measure within “reasonable period of time” (5 years since entry into force of SPS Agreement)

13. Apples – Article 5.7 Not justified as a provisional measure (Art. 5.7) • Sufficient scientific evidence exists to do risk assessment • Scientific uncertainty does not justify measure under Art. 5.7

14. GMOs – Article 5.7 EC member State bans Art. 5.7 inapplicable • Sufficient scientific evidence exists for EC risk assessments • ALOP does not determine sufficiency of evidence • Need evidence that what was once sufficient evidence is now insufficient

15. Discussions in the Committee • “reasonable” test – if disease outbreak, new situation, etc (BSE, AI) • Emergency measures not based on international standards • Excessive reactions • Emergency measures maintained despite sufficient evidence

16. Non-discrimination Scientific justification harmonization risk assessment consistency least trade-restrictiveness Equivalence Regionalization Transparency Technical assistance/special treatment Control, inspection and approval procedures Who sets agenda? Developing country participation? Minimum vs. maximum requirements How long? Right to exceed …. Key Provisions of the SPS Agreement

17. 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.

18. 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.

19. Article 3.3 Members may introduce or maintain SPS 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 ALOPin accordance with the relevant provisions of paragraphs 5.1 – 5.8 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. * For the purposes of paragraph 3 of Article 3, there is a scientific justification if, on the basis of an examination and evaluation of available scientific information in conformity with the relevant provisions of this Agreement, a Member determines that the relevant international standards, guidelines or recommendations are not sufficient to achieve its appropriate level of sanitary or phytosanitary protection.

20. Standard-setting organizations food safety plant health animal health OIE CODEX IPPC HarmonizationArticle 3 Codex = Joint FAO/WHO Codex Alimentarius Commission OIE = World Organization for Animal Health IPPC = International Plant Protection Convention (FAO)

21. EC Hormones – Article 3 • Codex standards for 5 of 6 hormones • EC measure not based on Codex • “based on” requires some but not all elements to be same • “conforms to” stricter requirement • Art. 3.3 is conditional right • To be consistent with Art. 3.3, must comply with Art.5 (risk assessment)

22. Harmonization — Monitoring G/SPS/11/Rev.1 • Aim of encouraging Members to use international standards • Identifying where there is a major impact on trade resulting from the non-use of standards • Help to understand when an international standard, guideline or recommendation is needed by: • Identifying the required international standard • Information from Members on their use or non-use of the identified standards, guidelines or recommendations

23. New Notification Procedures Recommendation to notify all new or modified SPS measures, even when based on / conform to relevant international standards, guidelines or recommendations G/SPS/7/Rev. 3 – takes effect 1 December 2008

24. Non-discrimination Scientific justification harmonization risk assessment consistency least trade-restrictiveness Equivalence Regionalization Transparency Technical assistance/special treatment Control, inspection and approval procedures How long? What methodology? Whose science? How determine if “based on”? Importer vs. Exporter responsibilities Key Provisions of the SPS Agreement

25. Risk AssessmentArticle 5.1 Members shall ensure that their SPS measures are based on • an assessment, as appropriate, of the risks to human, animal or plant life or health, • taking into account risk assessment techniques developed by the relevant international organizations.

26. Risk Assessment – food safety 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

27. Risk assessment – plant / animal health 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 measures which might be applied, and of the associated potential biological and economic consequences.

28. EC Hormones – risk assessment Measures not based on risk assessment (Art. 5.1) • “Based on” requires an objective and observable relationship between the measure and the risk assessment • Quantitative or qualitative risk assessment ok • Does not exclude factors that cannot be quantitatively assessed • Risk assessments provided did not support prohibition

29. Salmon – risk assessment Measures not based on appropriate risk assessment (Art. 5.1) • Identify the diseases which a Member wants to stop from entering • Evaluate the probability of entry, establishment and dissemination in the case of diseases • As a function of the SPS measures which could be applied.

30. Fire blight – risk assessment Measure not based on risk assessment (Art. 5.1) • Risk assessment not specific to risk from imports of mature apples • Did not take into account possible risk mitigation measures

31. GMOs – risk assessment EC member State bans • Not supported by EC risk assessment • Not based on new risk assessments - did not evaluate likelihood of entry/ establishment / spread and potential consequences according to risk mitigation measures

32. Non-discrimination Scientific justification harmonization risk assessment consistency least trade-restrictiveness Equivalence Regionalization Transparency Technical assistance/special treatment Control, inspection and approval procedures What ALOP? How determine consistency? Evolving science Evolving consumer demands Key Provisions of the SPS Agreement

33. ConsistencyArticle 5.5 Members shall avoid arbitrary distinctions in appropriate level of SPS protection (ALOP) considered in different situations if distinctions result in discrimination or disguised restrictions on trade

34. Hormones – Article 5.5 “Consistency” is objective, not obligation 3 requirements for violation of Article 5.5 ● Different levels of protection in different (but comparable) situations ● Different levels are arbitrary or unjustified ● Differences result in discrimination or disguised restriction to trade

35. Hormones – Article 5.5 Different treatment for: • administered natural hormones for growth promotion compared to those occurring endogenously in meat and other foods • synthetic hormones for growth promotion compared to natural hormones occurring endogenously in meat and other foods • hormones used for growth-promotion purposes and carbadox (anti-microbial growth-promoter used as a feed additive in swine production)

36. Salmon – Article 5.5 No consistency in level of risk accepted (Art. 5.5) Permitted importation of other products capable of transmitting some of the same diseases – e.g., live bait fish, live ornamental fish

37. Consistency – Committee Guidelines(G/SPS/15) • Two parts: • A) Appropriate level of sanitary or phytosanitary protection (ALOP) • B) SPS Measures • Principal points: • Clear identification of the level of protection • Compare the level of protection / measure with • Previous decisions • International standards / other countries • Transparency and communication between agencies

38. Consistency – guidelines(G/SPS/15) • Each Member should make public its ALOP • A Member should compare the levels of protection achieved by different measures, to avoid arbitrary or unjustified differences • Each authority that applies ALOP should be informed of the national policy on level of protection • Each competent authority should be informed of activities of other authorities

39. Consistency – guidelines (G/SPS/15) • Have common objectives and/or consistent procedures for evaluating measures that can be applied to achieve the ALOP • If the ALOP changes, existing measures should be reviewed to ensure consistency • Existing measures should be revised regularly and modified if necessary to meet existing ALOP

40. Non-discrimination Scientific justification harmonization risk assessment consistency least trade-restrictiveness Equivalence Regionalization Transparency Technical assistance/special treatment Control, inspection and approval procedures What ALOP? How determine trade effects? How determine feasibility? Whose feasibility? Key Provisions of the SPS Agreement

41. Article 5.6 Without prejudice to paragraph 2 of Article 3, when establishing or maintaining sanitary or phytosanitary measures to achieve the appropriate level of sanitary or phytosanitary protection, Members shall ensure that such measures are not more trade-restrictive than required to achieve ALOP, taking into account technical and economic feasibility. * … a measure is not more trade-restrictive than required unless there is another measure, reasonably available taking into account technical and economic feasibility, that achieves the ALOP and is significantly less restrictive to trade.

42. Salmon 21.5 – Article 5.6 “Consumer ready” requirement – packages of less than 450 g. • More trade restrictive than necessary (Art. 5.6)

43. Fire blight – Article 5.6 More trade restrictive than necessary (Art. 5.6) proposed alternative SPS measure - requiring that only mature, symptomless apples be exported - was • reasonably available; • achieved Japan's ALOP; and • significantly less restrictive to trade

44. Non-discrimination Scientific justification harmonization risk assessment consistency least trade-restrictiveness Equivalence Regionalization Transparency Technical assistance/special treatment Control, inspection and approval procedures What ALOP? How determine? How long? Who does what? Key Provisions of the SPS Agreement

45. What is « equivalence »? Article 4  Members shall accept the sanitary and phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member’s appropriate level of sanitary and phytosanitary protection

46. What is « equivalence »? • Legal terms - Article 4 • In practice – ?

47. Equivalence – in practice • How determine if another measure / process / product is equally safe? • Is aging equivalent to pasteurization re: cheese safety? • Can cold treatment replace fumigation? • Can vaccination ensure disease freedom? • What is the ALOP (acceptable risk level)?

48. Equivalence – Committee Guidelines(G/SPS/19/Rev.2) • Can be requested for individual measures / products or whole systems • Importing country should identify risks and explain its ALOP • Importing country should provide its risk assessment or technical justification for its own measure • Respond to requests within 6 months

49. Equivalence – Committee Guidelines(G/SPS/19/Rev.2) • Take into account current history of trade • Provide technical assistance to developing countries who request recognition of equivalence • Notify SPS Committee when equivalence is recognized • SPS Committee to follow recognition agreements, bilateral arrangements • Encourage Codex, OIE and IPPC to develop guidelines for equivalence

50. Equivalence - Notifications Two notifications so far: • Dominican Republic – USA • Panama – United States