The SPS Agreement and its provisions relating to

The SPS Agreement and its provisions relating to scientific evidence WTO Slide 1

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 WTO Slide 2

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

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” WTO Slide 4

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. ” WTO Slide 5

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. WTO Slide 6

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

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. WTO Slide 8

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 WTO Slide 9

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 WTO Slide 10

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 (? ) WTO Slide 11

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

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 WTO Slide 13

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 WTO Slide 14

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. ” WTO Slide 15

Article 5: 7 “qualified exemption” Panel - Varietals • Japan specifically invoked 5: 7. It claimed 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. WTO Slide 16

Article 5: 7 “qualified exemption” Panel - Varietals Allowed to provisionally adopt a measure if: 1 and 2 WTO 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” Slide 17

Article 5: 7 “qualified exemption” Panel - Varietals + additional obligations: 3 and 4 WTO “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”. Slide 18

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 WTO ……. Article 2. 2 Slide 19

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 WTO Slide 20

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. WTO Slide 21

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. WTO Slide 22

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. 3 risk assessment Article 5. 5 consistency Article 5. 7 insufficient scientific. . . WTO Slide 23

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. ” WTO Slide 24

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” WTO Slide 25

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. ” WTO Slide 26

Risk Assessment (Article 5. 1 - 5. 3) Article 5. 1 Article 5. 2 Article 5. 3 WTO • 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 Slide 27

Article 5. 1 -5. 3 risk assessment Focus on 2. 2 “scientific evidence” Hormones food safety (5. 1 -5. 2) WTO Salmon Varietals animal health (5. 1 -5. 3) Slide 28

Article 5. 1 -5. 2 risk assessment Panel - Hormones 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". – WTO SPS Agreement, Annex A, Paragraph 4, second sentence Slide 29

Article 5. 1 -5. 2 risk assessment Panel - Hormones WTO 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

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. WTO Slide 31

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. WTO Slide 32

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 WTO Slide 33

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 WTO Slide 34

Article 5. 1 -5. 2 risk assessment Panel - Hormones Article 2. 2 “lack of an objective relationship” measure scientific conclusions reached in each of the studies compared to the scientific evidence before the Panel WTO Article 5. 1 the scientific conclusion reflected in the measure Slide 35

Article 5. 1 -5. 2 risk 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. WTO Slide 36

Article 5. 1 -5. 3 risk assessment Article 2 Hormones food safety (5. 1 -5. 2) WTO Salmon Varietals animal health (5. 1 -5. 3) Slide 37

Article 5. 1 -5. 2 risk assessment Panel - Salmon 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". – WTO SPS Agreement, Annex A, Paragraph 4, first sentence Slide 38

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 WTO Slide 39

Article 5. 1 -5. 2 risk assessment Panel - Salmon WTO 1 “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 2 “evaluate the likelihood of entry, establishment or spread of these diseases, as well as the associated potential biological and economic consequences; and, 3 “evaluate the likelihood of entry, establishment and spread of these diseases according to the SPS measure which might be applied Slide 40

Article 5. 1 -5. 2 risk assessment Panel - Salmon 1 “identify” • Consistent = no violation of Article 5. 1 – 24 diseases identified. . . 2 3 “evaluate the likelihood of entry “… according to the SPS measure …” • 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) WTO Slide 41

Article 5. 1 -5. 2 risk assessment AB - Salmon 1 “identify” 2 “evaluate the likelihood of entry 3 “… according to the SPS measure …” • Consistent (agreed with Panel) Article 5. 1 Article 2. 2 • 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 WTO Slide 42

summary so far Risk Assessment (Article 5. 1 -5. 2) Scientific evidence (Article 2. 2) Hormones Salmon Varietals • 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 WTO Slide 43

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. 3 risk assessment Article 5. 5 consistency Article 5. 7 insufficient scientific. . . WTO Slide 44

“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” WTO Slide 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. WTO Slide 46

“consistency” (Article 5. 5) Not an issue Hormones Salmon Three pronged test (Varietals) Q 1 Q 2 WTO Q 3 Slide 47

“consistency” (Article 5. 5) Q 2 Q 1 Are the situations comparable? Are there different levels of protection? Are the differences in levels of protection “arbitrary or unjustifiable”? Do the differences result in “discrimination or a disguised restriction on international trade? ” Panel WTO Q 3 AB Slide 48

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) WTO Slide 49

1 SITUATION Different treatment for: administered natural hormones for growth promotion compared to those occurring endogenously in meat and other foods Q 2 Q 1 Q 3 • 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. WTO Slide 50

1 SITUATION Different treatment for: administered natural hormones for growth promotion compared to (i) those occurring endogenously in meat and other foods; Q 1 • Q 2 Q 3 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 WTO Slide 51

1 SITUATION Different treatment for: administered natural hormones for growth promotion compared to (i) those occurring endogenously in meat and other foods; Q 1 Q 2 Q 3 AB: Reversed • “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 naturallyoccurring 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. ” – WTO Hormones, AB Report, para. 221. Slide 52

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) WTO Slide 53

2 Q 1 • Different treatment for: synthetic hormones for growth promotion compared to natural hormones occurring endogenously in meat and other foods Q 2 Q 3 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 WTO Slide 54

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) WTO Slide 55

3 Q 1 • Different treatment for: hormones used for growthpromotions purposes and carbadox (anti-microbial growth-promoter used as a feed additive in swine production) Q 2 Q 3 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 AB: Reversed WTO Slide 56

3 Different treatment for: hormones used for growthpromotions purposes and carbadox (anti-microbial growth-promoter used as a feed additive in swine production) Q 1 Q 2 Q 3 AB: Reversed • “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. ” – WTO Hormones, AB Report, para. 245. Slide 57

“consistency” (Article 5. 5) - summary Q 1 Q 2 Q 3 1 2 Violation of 5: 5 3 AB: Reversed WTO Slide 58

3&4 SITUATION 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. Q 1 Q 2 Q 3 • 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) AB: Upheld WTO Slide 59

3&4 SITUATION 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. Q 1 Q 2 Q 3 • 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. AB: Upheld WTO Slide 60

3&4 SITUATION 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. Q 1 • • • WTO 1 st warning signal 2 nd warning signal 3 rd warning signal 1 st additional factor 2 nd additional factor 3 rd additional factor Q 2 Q 3 Article 5: 5 Slide 61

3&4 SITUATION Q 3 • • 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: Panel’s doubts do not carry much wait but can be taken into consideration WTO Slide 62

3&4 SITUATION 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. Q 1 • • • 1 st warning signal 2 nd warning signal 3 rd warning signal 1 st additional factor 2 nd additional factor 3 rd additional factor Q 2 Q 3 Article 5: 5 AB: Upheld WTO Slide 63

“consistency” (Article 5. 5) - summary - Q 1 3&4 WTO Q 2 Q 3 Violation of 5: 5 Slide 64

“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. Separate requirement of discrimination Q 3 Do the differences result in “discrimination or a disguised restriction on international trade? ” Comparable situations, a broad concept WTO Slide 65

Harmonization (Article 3) 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” WTO Slide 66

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

Harmonization (Article 3) 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. ” WTO Slide 68

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

Harmonization (Article 3) 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. WTO Slide 70

Harmonization (Article 3) Article 3. 1 shall base. . . Hormones Article 3. 2 conform to. . . consistent Salmon started with Article 5 and then found that there was no need to go further WTO Article 3. 3 higher level Varietals no claims Slide 71

Harmonization (Article 3) Article 3. 1 shall base. . . measures on international standards Article 3. 2 Article 3. 3 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. WTO Slide 72

Harmonization (Article 3) Article 3. 1 shall base. . . measures on international standards Article 3. 2 conform to. . . consistent Article 3. 3 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 WTO Slide 73

Harmonization (Article 3) AB - Hormones “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 WTO Slide 74

Harmonization (Article 3) Article 3. 1 shall base. . . measures on international standards Article 3. 2 conform to. . . consistent Article 3. 3 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. WTO Slide 75

Harmonization (Article 3) Article 3. 1 shall base. . . measures on international standards Article 3. 2 conform to. . . consistent Article 3. 3 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. WTO Slide 76

Harmonization (Article 3) Article 3. 1 shall base. . . measures on international standards Article 3. 2 conform to. . . consistent Article 3. 3 higher level AB: Agreed with Panel’s conclusion • Agreed with the Panel’s 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. WTO Slide 77

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) WTO Slide 78

Internet: “www. wto. org” “Hormones” (two) EC Measures Concerning Meat and Meat Products (Hormones) WT/DS 26 and 48/. . . “Salmon” Australia - Measures Affecting Importation of Salmon WT/DS 18/. . . “Varietals” Japan - Measures Affecting Agricultural Products WT/DS 76/. . . WTO Slide 79

The SPS Agreement and its provisions relating to scientific evidence WTO Slide 80