1、WTO,Slide 1,The SPS Agreement and its provisions relating to scientific evidence,WTO,Slide 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 Pr
2、oducts,WTO,Slide 3,“science”,WTO,Slide 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 Obli
3、gations (Article 2),WTO,Slide 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
4、 as provided for in paragraph 7 of Article 5.”,Basic Rights and Obligations (Article 2),WTO,Slide 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
5、 sufficient scientific evidence,except as provided for in paragraph 7 of Article 5.,WTO,Slide 7,Hormones,Salmon,Varietals,Article 2:2 (Basic Rights and Obligations),WTO,Slide 8,“In our view, for a phytosanitary measure to be maintained without sufficient scientific evidence, there needs to be a lack
6、 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 Rep
7、ort, para. 8.29.,Panel - Varietals,Article 2:2 (Basic Rights and Obligations),WTO,Slide 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 betw
8、een 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),WTO,Slide 10,Article 2.2,shall ensure:,Basic Rights and Obligations,applied only to the extent necessary to
9、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,WTO,Slide 11,Article 2:2 (Basic Rights and Obligations),Panel - Varietals,“lack of an objective relationship”,“m
10、easure”,“the scientific evidence submitted before the Panel”,WTO,Slide 12,AB - Varietals,Upheld. (with respect to apples, cherries, nectarines and walnuts)Japan -Varietals, AB, para. 85.,Article 2:2 (Basic Rights and Obligations),WTO,Slide 13,What about the exception to the rule of basing SPS measur
11、es 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 14,Article 2.2,shall ensure:,Basic Rights and Obligatio
12、ns,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,WTO,Slide 15,Where scientific evidence is insufficient (Article 5.7),
13、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 phytos
14、anitary 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 16,Article 5:7 “qual
15、ified exemption”,Japan specifically invoked 5:7. It claimed that that its measure could be considered a provisional measureThe Panel found that four cumulative elements needed to be shown for a measure to be consistent with Article 5.7.,Panel - Varietals,WTO,Slide 17,Article 5:7 “qualified exemption
16、”,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,WTO,Slide 18,Article 5:7 “qualified exemption”,P
17、anel - 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,WTO,Slide 19,Article 5:7 “qualified exemption”,Panel - Varietals,Pa
18、nel examined only the third and fourth elementsno 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,WTO,Slide 20,AB - Varietals,Article 5:7 “qualified exemption”,Upheld.
19、 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 21,Article 5:7 “qualified exemption”,The EC did not invoke Article 5.7,
20、 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 sc
21、ientific evidence and uncertainty.,Panel - Hormones,WTO,Slide 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
22、 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,WTO,Slide 23,Article 5 - Risk Assessment “Assessment of Risk and Determination of the A
23、ppropriate Level of Sanitary or Phytosanitary Protection”,Article 5.1-5.3 risk assessment,Article 5.5 consistency,Article 5,Article 2.2,WTO,Slide 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 appro
24、priate 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 25,Risk Assessment (Article 5.1 - 5.3),Article 5.2“In the assessment of risks, Members shall take into
25、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、”,WTO,Slide 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 eco
27、nomic 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
28、 risks.”,WTO,Slide 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 assessmentwhat to take into account (available scientific evidence, etc.)for animal and plant health, what economic factors to take into account,WTO,Slide 28,Hormones,Salmo
29、n,Varietals,Article 5.1-5.3 risk assessment,WTO,Slide 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-cau
30、sing organisms in food, beverages or feedstuffs“.SPS Agreement, Annex A, Paragraph 4, second sentence,Panel - Hormones,WTO,Slide 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
31、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,WTO,Slide 31,Article 5.1-5.2 risk assessment,Panel - Hormones,Existence of a risk assessment?The EC had invoked several scientific reports that
32、the experts advising the Panel considered to be risk assessmentsFor five of the hormones, the Panel assumed that the EC had demonstrated the existence of a risk assessment.,WTO,Slide 32,Article 5.1-5.2 risk assessment,Panel - Hormones,However, the Panel found that the EC measure was not based on the
33、 scientific evidence submitted.,WTO,Slide 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 sa
34、fe, 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 34,Article 5.1-5.2 risk assessment,Panel - Hormones,“ The EC import ban of meat and meat products from animals treated with an
35、y 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 sub
36、mitted to the Panel.”EC-Hormones, Panel Report, para. 8.137,WTO,Slide 35,Panel - Hormones,Article 5.1-5.2 risk assessment,compared to, Article 5.1,WTO,Slide 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 li
37、st (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,WTO,Slide 37,Hormones,Salmon,Varietals,Article 5.1-5.3 risk assessment,WTO,Slide 38,Article 5.1-5.2 risk assessment,The d
38、efinition 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 potentia
39、l biological and economic consequences“.SPS Agreement, Annex A, Paragraph 4, first sentence,Panel - Salmon,WTO,Slide 39,The difference between the two definitions:Food borne: evaluation of the potential for adverse effects on human or animal healthDisease or pest risk: an evaluation of the likelihoo
40、d of entry, establishment or spread of a disease, and the associated potential biological and economic consequences,Risk Assessment (Annex A - Definition),WTO,Slide 40,Article 5.1-5.2 risk assessment,Panel - Salmon,“identify the disease(s) whose entry, establishment or spread within its territory it
41、 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
42、spread of these diseases according to the SPS measure which might be applied,2,1,3,WTO,Slide 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 assessmentNo finding
43、 - 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,WTO,Slide 42,Article 5.1-5.2 ri
44、sk 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 li
45、kelihood, 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,WTO,Slide 43,Hormones,Salmon,Varietals,summary so far,Scientific evidence (Article 2.2),Risk Assessment (Article 5
46、.1-5.2),Risk Assessment (Article 5.1-5.2),Rational relationship between the measure and the scienceThe approach to a risk assessment: food-borne: identify / evaluate potential disease- or pest borne: identify / evaluate likelihood / according to measure applied,WTO,Slide 44,Article 5 - Risk Assessme
47、nt “Assessment 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 2.2,WTO,Slide 45,“consistency” (Article 5.5),“With the objective of achieving consistency in the application of the con
48、cept 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 r
49、esult 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 sh
50、all take into account all relevant factors, including the exceptional character of human health risks to which people voluntarily expose themselves”,WTO,Slide 46,“With the objective of achieving consistency in the application of the concept of appropriate level of sanitary or phytosanitary protectio
51、n 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.,
