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Issues covered by the WTO’s committees and agreements

REPERTORY OF APPELLATE BODY REPORTS

SPS Agreement


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Difference between the appropriate level of protection and the SPS measure chosen to implement. See also SPS Agreement, Article 5 (S.6.9-23)
Article 2 — Basic rights and obligations. See also SPS Agreement, Article 5.1 (S.6.9-14)
Article 2.2 — “sufficient scientific evidence”. See also Burden of Proof, Presumption — prima facie case (B.3.2); SPS Agreement, Article 5.1 (S.6.9-14); SPS Agreement, Article 5.7 (S.6.19-23)
Article 2.3 — “not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail”. See also SPS Agreement, Article 5.5 (S.6.15-17)
Article 3 — Level of protection and harmonization of SPS measures
Article 3.1 — “measures based on… international standards”
Article 3.2 — “measures which conform to international standards”
Article 3.3 — “measures which result in a higher level of… protection”
Article 5.1 and Annex A, paragraph 4 — Concept of risk assessment
Article 5.1 — Ascertainable risk
Article 5.1 — Types of risk assessment
Article 5.1 — Degree of risk
Articles 5.1 and 5.2 — Risk assessment — Specific to the risk identified
Article 5.1 — Requirement to base measure on the risk assessment
Article 5.5 — Consistency in the application of the appropriate level of protection
Article 5.5 — Distinctions in the level of protection in different situations
Article 5.5 — “result in discrimination or a disguised restriction”
Article 5.6 — Not more trade restrictive than required to achieve the appropriate level of protection
Article 5.7 — Provisional adoption of SPS measures
Article 5.7 — “where relevant scientific evidence is insufficient”
Article 5.7 — “on the basis of available, pertinent information”
Article 5.7 — “seek to obtain additional information”
Article 5.7 — “review… within a reasonable period of time”
Article 5.7 — Precautionary principle
Annex B on “Transparency of SPS Regulations”, paragraph 1 — “publication of laws, decrees or ordinances”


S.6.1 Difference between the appropriate level of protection and the SPS measure chosen to implement. See also SPS Agreement, Article 5 (S.6.9-23)     back to top

S.6.1.1 Australia — Salmon, para. 199
(WT/DS18/AB/R)

 

We do not believe that Article 11 of the DSU, or any other provision of the DSU or of the SPS Agreement, entitles the Panel or the Appellate Body, for the purpose of applying Article 5.6 in the present case, to substitute its own reasoning about the implied level of protection for that expressed consistently by Australia. The determination of the appropriate level of protection, a notion defined in paragraph 5 of Annex A, as “the level of protection deemed appropriate by the Member establishing a sanitary … measure”, is a prerogative of the Member concerned and not of a panel or of the Appellate Body.

 

S.6.1.2 Australia — Salmon, paras. 200-201
(WT/DS18/AB/R)

 

The “appropriate level of protection” established by a Member and the “SPS measure” have to be clearly distinguished. They are not one and the same thing. The first is an objective, the second is an instrument chosen to attain or implement that objective.

 

It can be deduced from the provisions of the SPS Agreement that the determination by a Member of the “appropriate level of protection” logically precedes the establishment or decision on maintenance of an “SPS measure”. The provisions of the SPS Agreement also clarify the correlation between the “appropriate level of protection” and the “SPS measure”.

 

S.6.1.3 Australia — Salmon, para. 203
(WT/DS18/AB/R)

 

… The words of Article 5.6, in particular the terms “when establishing or maintaining sanitary … protection”, demonstrate that the determination of the level of protection is an element in the decision-making process which logically precedes and is separate from the establishment or maintenance of the SPS measure. It is the appropriate level of protection which determines the SPS measure to be introduced or maintained, not the SPS measure introduced or maintained which determines the appropriate level of protection. To imply the appropriate level of protection from the existing SPS measure would be to assume that the measure always achieves the appropriate level of protection determined by the Member. That clearly cannot be the case.

 

S.6.1.4 Australia — Salmon, para. 206
(WT/DS18/AB/R)

 

We thus believe that the SPS Agreement contains an implicit obligation to determine the appropriate level of protection. We do not believe that there is an obligation to determine the appropriate level of protection in quantitative terms. This does not mean, however, that an importing Member is free to determine its level of protection with such vagueness or equivocation that the application of the relevant provisions of the SPS Agreement, such as Article 5.6, becomes impossible. It would obviously be wrong to interpret the SPS Agreement in a way that would render nugatory entire Articles or paragraphs of Articles of this Agreement and allow Members to escape from their obligations under this Agreement.

 

S.6.1.5 Australia — Salmon, para. 207
(WT/DS18/AB/R)

 

… we believe that in cases where a Member does not determine its appropriate level of protection, or does so with insufficient precision, the appropriate level of protection may be established by panels on the basis of the level of protection reflected in the SPS measure actually applied. Otherwise, a Member’s failure to comply with the implicit obligation to determine its appropriate level of protection — with sufficient precision — would allow it to escape from its obligations under this Agreement and, in particular, its obligations under Articles 5.5 and 5.6.

 

S.6.1.6 US — Continued Suspension / Canada — Continued Suspension, para. 523
(WT/DS320/AB/R, WT/DS321/AB/R)

 

… It is the “prerogative” of a WTO Member to determine the level of protection that it deems appropriate. The SPS measure is the “instrument” chosen by the WTO Member to implement its sanitary or phytosanitary objective. Based on the wording of Article 5.6 of the SPS Agreement, the Appellate Body has explained that the “determination of the level of protection is an element in the decision-making process which logically precedes and is separate from the establishment or maintenance of the SPS measure”. In other words, the appropriate level of protection determines the SPS measure to be introduced or maintained, rather than the appropriate level of protection being determined by the SPS measure. The Appellate Body has also found that “the SPS Agreement contains an implicit obligation to determine the appropriate level of protection”. Although it need not be determined in quantitative terms, the level of protection cannot be determined “with such vagueness or equivocation that the application of the relevant provisions of the SPS Agreement … becomes impossible”.

 
S.6.2 Article 2 — Basic rights and obligations. See also SPS Agreement, Article 5.1 (S.6.9-14)     back to top

S.6.2.1 EC — Hormones, para. 250
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… We are, of course, surprised by the fact that the Panel did not begin its analysis of this whole case by focusing on Article 2 that is captioned “Basic Rights and Obligations”, an approach that appears logically attractive. We recall the reading that we have given above to Articles 2 and 5 — that Article 2.2 informs Article 5.1, and that similarly Article 2.3 informs Article 5.5 — but believe that further analysis of their relationship should await another case.

 
S.6.3 Article 2.2 — “sufficient scientific evidence”. See also Burden of Proof, Presumption — prima facie case (B.3.2); SPS Agreement, Article 5.1 (S.6.9-14); SPS Agreement, Article 5.7 (S.6.19-23)     back to top

S.6.3.1 EC — Hormones, para. 177
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… The requirements of a risk assessment under Article 5.1, as well as of “sufficient scientific evidence” under Article 2.2, are essential for the maintenance of the delicate and carefully negotiated balance in the SPS Agreement between the shared, but sometimes competing, interests of promoting international trade and of protecting the life and health of human beings. …

 

S.6.3.2 EC — Hormones, para. 180
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… the Panel considered that Article 5.1 may be viewed as a specific application of the basic obligations contained in Article 2.2 of the SPS Agreement …

 

… We agree with this general consideration and would also stress that Articles 2.2 and 5.1 should constantly be read together. Article 2.2 informs Article 5.1: the elements that define the basic obligation set out in Article 2.2 impart meaning to Article 5.1.

 

S.6.3.3 Australia — Salmon, para. 138
(WT/DS18/AB/R)

 

… by maintaining an import prohibition … in violation of Article 5.1, Australia has, by implication, also acted inconsistently with Article 2.2 of the SPS Agreement.

 

S.6.3.4 Japan — Agricultural Products II, paras. 73-74
(WT/DS76/AB/R)

 

… we can conclude that “sufficiency” is a relational concept. “Sufficiency” requires the existence of a sufficient or adequate relationship between two elements, in casu, between the SPS measure and the scientific evidence.

 

The context of the word “sufficient” or, more generally, the phrase “maintained without sufficient scientific evidence” in Article 2.2, includes Article 5.1 as well as Articles 3.3 and 5.7 of the SPS Agreement.

 

S.6.3.5 Japan — Agricultural Products II, para. 84
(WT/DS76/AB/R)

 

… we agree with the Panel that the obligation in Article 2.2 that an SPS measure not be maintained without sufficient scientific evidence requires that there be a rational or objective relationship between the SPS measure and the scientific evidence. Whether there is a rational relationship between an SPS measure and the scientific evidence is to be determined on a case-by-case basis and will depend upon the particular circumstances of the case, including the characteristics of the measure at issue and the quality and quantity of the scientific evidence.

 

S.6.3.6 Japan — Agricultural Products II, para. 80
(WT/DS76/AB/R)

 

… Article 5.7 allows Members to adopt provisional SPS measures “[i]n cases where relevant scientific evidence is insufficient” and certain other requirements are fulfilled. Article 5.7 operates as a qualified exemption from the obligation under Article 2.2 not to maintain SPS measures without sufficient scientific evidence. An overly broad and flexible interpretation of that obligation would render Article 5.7 meaningless.

 

S.6.3.7 Japan — Apples, paras. 163-164
(WT/DS245/AB/R)

 

As we see it, the Panel examined the evidence adduced by the parties and considered the opinions of the experts. It concluded as a matter of fact that it is not likely that apple fruit would serve as a pathway for the entry, establishment or spread of fire blight in Japan. The Panel then contrasted the extent of the risk and the nature of the elements composing the measure, and concluded that the measure was “clearly disproportionate to the risk identified on the basis of the scientific evidence available”. For the Panel, such “clear disproportion” implies that a “rational or objective relationship” does not exist between the measure and the relevant scientific evidence, and, therefore, the Panel concluded that the measure is maintained “without sufficient scientific evidence” within the meaning of Article 2.2 of the SPS Agreement. We note that the “clear disproportion” to which the Panel refers, relates to the application in this case of the requirement of a “rational or objective relationship between an SPS measure and the scientific evidence”.

 

We emphasize, following the Appellate Body’s statement in Japan Agricultural Products II [at paragraph 84], that whether a given approach or methodology is appropriate in order to assess whether a measure is maintained “without sufficient scientific evidence”, within the meaning of Article 2.2, depends on the “particular circumstances of the case”, and must be “determined on a case-by-case basis”. Thus, the approach followed by the Panel in this case — disassembling the sequence of events to identify the risk and comparing it with the measure — does not exhaust the range of methodologies available to determine whether a measure is maintained “without sufficient scientific evidence” within the meaning of Article 2.2. Approaches different from that followed by the Panel in this case could also prove appropriate to evaluate whether a measure is maintained without sufficient scientific evidence within the meaning of Article 2.2. Whether or not a particular approach is appropriate will depend on the “particular circumstances of the case”. The methodology adopted by the Panel was appropriate to the particular circumstances of the case before it and, therefore, we see no error in the Panel’s reliance on it.

 

S.6.3.8 US — Continued Suspension / Canada — Continued Suspension, para. 674
(WT/DS320/AB/R, WT/DS321/AB/R)

 

Under Article 2.2 of the SPS Agreement, WTO Members are required to “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”. This requirement is made operative in other provisions of the SPS Agreement, including Article 5.1, which requires SPS measures to be “based on” a risk assessment. At the same time, Article 2.2 excludes from its scope of application situations in which the relevant scientific evidence is insufficient. In such situations, the applicable provision is Article 5.7 of the SPS Agreement. Thus, the applicability of Articles 2.2 and 5.1, on the one hand, and of Article 5.7, on the other hand, will depend on the sufficiency of the scientific evidence. The Appellate Body has explained that the relevant scientific evidence will be considered “insufficient” for purposes of Article 5.7 “if the body of available scientific evidence does not allow, in quantitative or qualitative terms, the performance of an adequate assessment of risks as required under Article 5.1 and as defined in Annex A to the SPS Agreement”. This means that where the relevant scientific evidence is sufficient to perform a risk assessment, as defined in Annex A of the SPS Agreement, a WTO Member may take an SPS measure only if it is “based on” a risk assessment in accordance with Article 5.1 and that SPS measure is also subject to the obligations in Article 2.2. If the relevant scientific evidence is insufficient to perform a risk assessment, a WTO Member may take a provisional SPS measure on the basis provided in Article 5.7, but that Member must meet the obligations set out in that provision.

 
S.6.4 Article 2.3 — “not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail”. See also SPS Agreement, Article 5.5 (S.6.15-17)     back to top

S.6.4.1 Australia — Salmon, para. 252
(WT/DS18/AB/R)

 

… a finding of violation of Article 5.5 will necessarily imply a violation of Article 2.3, first sentence, or Article 2.3, second sentence. Discrimination “between Members, including their own territory and that of others Members” within the meaning of Article 2.3, first sentence, can be established by following the complex and indirect route worked out and elaborated by Article 5.5. However, it is clear that this route is not the only route leading to a finding that an SPS measure constitutes arbitrary or unjustifiable discrimination according to Article 2.3, first sentence. Arbitrary or unjustifiable discrimination in the sense of Article 2.3, first sentence, can be found to exist without any examination under Article 5.5.

 
S.6.5 Article 3 — Level of protection and harmonization of SPS measures     back to top

S.6.5.1 EC — Hormones, para. 104
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… It appears to us that the Panel has misconceived the relationship between Articles 3.1, 3.2 and 3.3, a relationship discussed below, which is qualitatively different from the relationship between, for instance, Articles I or III and Article XX of the GATT 1994. Article 3.1 of the SPS Agreement simply excludes from its scope of application the kinds of situations covered by Article 3.3 of that Agreement, that is, where a Member has projected for itself a higher level of sanitary protection than would be achieved by a measure based on an international standard. …

 

S.6.5.2 EC — Hormones, para. 177
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… In generalized terms, the object and purpose of Article 3 is to promote the harmonization of the SPS measures of Members on as wide a basis as possible, while recognizing and safeguarding, at the same time, the right and duty of Members to protect the life and health of their people. The ultimate goal of the harmonization of SPS measures is to prevent the use of such measures for arbitrary or unjustifiable discrimination between Members or as a disguised restriction on international trade, without preventing Members from adopting or enforcing measures which are both “necessary to protect” human life or health and “based on scientific principles”, and without requiring them to change their appropriate level of protection. …

 

S.6.5.3 US — Continued Suspension / Canada — Continued Suspension, para. 692
(WT/DS320/AB/R, WT/DS321/AB/R)

 

As the preamble of the SPS Agreement recognizes, one of the primary objectives of the SPS Agreement is to “further the use of harmonized sanitary and phytosanitary measures between Members, on the basis of international standards, guidelines and recommendations developed by the relevant international organizations”. This objective finds reflection in Article 3 of the SPS Agreement, which encourages the harmonization of SPS measures on the basis of international standards, while at the same time recognizing the WTO Members’ right to determine their appropriate level of protection. …

 
S.6.6 Article 3.1 — “measures based on… international standards”     back to top

S.6.6.1 EC — Hormones, para. 102
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… The presumption of consistency with relevant provisions of the SPS Agreement that arises under Article 3.2 in respect of measures that conform to international standards may well be an incentive for Members so to conform their SPS measures with such standards. It is clear, however, that a decision of a Member not to conform a particular measure with an international standard does not authorize imposition of a special or generalized burden of proof upon that Member, which may, more often than not, amount to a penalty.

 

S.6.6.2 EC — Hormones, paras. 165-166
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… We cannot lightly assume that sovereign states intended to impose upon themselves the more onerous, rather than the less burdensome, obligation by mandating conformity or compliance with such standards, guidelines and recommendations. To sustain such an assumption and to warrant such a far-reaching interpretation, treaty language far more specific and compelling than that found in Article 3 of the SPS Agreement would be necessary.

 

… we disagree with the Panel’s interpretation that “based on” means the same thing as “conform to”.

 

S.6.6.3 EC — Hormones, para. 171
(WT/DS26/AB/R, WT/DS48/AB/R)

 

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; but, as earlier observed, the Member is not penalized by exemption of a complaining Member from the normal burden of showing a prima facie case of inconsistency with Article 3.1 or any other relevant Article of the SPS Agreement or of the GATT 1994.

 
S.6.7 Article 3.2 — “measures which conform to international standards”     back to top

S.6.7.1 EC — Hormones, para. 102
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… The presumption of consistency with relevant provisions of the SPS Agreement that arises under Article 3.2 in respect of measures that conform to international standards may well be an incentive for Members so to conform their SPS measures with such standards. It is clear, however, that a decision of a Member not to conform a particular measure with an international standard does not authorize imposition of a special or generalized burden of proof upon that Member, which may, more often than not, amount to a penalty.

 

S.6.7.2 EC — Hormones, para. 170
(WT/DS26/AB/R, WT/DS48/AB/R)

 

Under Article 3.2 of the SPS Agreement, a Member may decide to promulgate an SPS measure that conforms to an international standard. Such a measure would embody the international standard completely and, for practical purposes, converts it into a municipal standard. Such a measure enjoys the benefit of a presumption (albeit a rebuttable one) that it is consistent with the relevant provisions of the SPS Agreement and of the GATT 1994.

 

S.6.7.3 US — Continued Suspension / Canada — Continued Suspension, para. 532
(WT/DS320/AB/R, WT/DS321/AB/R)

 

International standards are given a prominent role under the SPS Agreement, particularly in furthering the objective of promoting the harmonization of sanitary and phytosanitary standards between WTO Members. This is to be achieved by encouraging WTO Members to base their SPS measures on international standards, guidelines or recommendations, where they exist. There is a rebuttable presumption that SPS measures that conform to international standards, guidelines or recommendations are “necessary to protect human, animal or plant life or health, and… [are] consistent with the relevant provisions of this Agreement and of GATT 1994”. …

 

S.6.7.4 US — Continued Suspension / Canada — Continued Suspension, para. 694
(WT/DS320/AB/R, WT/DS321/AB/R)

 

It is therefore undisputed that JECFA has performed risk assessments for the six hormones at issue and that Codex has adopted international standards for five of these hormones on the basis of JECFA’s risk assessments. The fact that JECFA has performed risk assessments for all six hormones means that the relevant scientific evidence was in its estimation sufficient to do so. Article 3.2 provides that SPS measures which conform to international standards shall be deemed necessary to protect human, animal or plant life or health, and shall be presumed to be consistent with the relevant provisions of the SPS Agreement and of the GATT 1994. This presumption, however, does not apply where a Member has not adopted a measure that conforms with an international standard. Article 3.2 is inapplicable where a Member chooses a level of protection that is higher than would be achieved by a measure based on an international standard. The presumption in Article 3.2 cannot be interpreted to imply that there is sufficient scientific evidence to perform a risk assessment where a Member chooses a higher level of protection.

 

S.6.7.5 US — Continued Suspension / Canada — Continued Suspension, para. 710
(WT/DS320/AB/R, WT/DS321/AB/R)

 

We recall that the presumption in Article 3.2 is inapplicable where a WTO Member adopts an SPS measure that results in a higher level of protection than that reflected in an international standard. For this reason, Article 3.2 did not provide a basis for the Panel’s use of the JECFA risk assessments as the legal benchmark against which the insufficiencies in the relevant scientific evidence identified by the European Communities had to be evaluated. …

 
S.6.8 Article 3.3 — “measures which result in a higher level of… protection”     back to top

S.6.8.1 EC — Hormones, para. 104
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… It appears to us that the Panel has misconceived the relationship between Articles 3.1, 3.2 and 3.3, a relationship discussed below, which is qualitatively different from the relationship between, for instance, Articles I or III and Article XX of the GATT 1994 … Article 3.3 recognizes the autonomous right of a Member to establish such higher level of protection, provided that that Member complies with certain requirements in promulgating SPS measures to achieve that level. …

 

S.6.8.2 EC — Hormones, para. 172
(WT/DS26/AB/R, WT/DS48/AB/R)

 

Under Article 3.3 of the SPS Agreement, a Member may decide to set for itself a level of protection different from that implicit in the international standard, and to implement or embody that level of protection in a measure not “based on” the international standard. The Member’s appropriate level of protection may be higher than that implied in the international standard. The right of a Member to determine its own appropriate level of sanitary protection is an important right. This is made clear in the sixth preambular paragraph of the SPS Agreement:…

 

… [the] right of a Member to establish its own level of sanitary protection under Article 3.3 of the SPS Agreement is an autonomous right and not an “exception” from a “general obligation” under Article 3.1.

 

S.6.8.3 EC — Hormones, para. 173
(WT/DS26/AB/R, WT/DS48/AB/R)

 

The right of a Member to define its appropriate level of protection is, however, not an absolute or unqualified right. …

 

S.6.8.4 EC — Hormones, para. 175
(WT/DS26/AB/R, WT/DS48/AB/R)

 

Article 3.3 is evidently not a model of clarity in drafting and communication. The use of the disjunctive “or” does indicate that two situations are intended to be covered. These are the introduction or maintenance of SPS measures which result in a higher level of protection:

 

(a) “if there is a scientific justification”; or

 

(b) “as a consequence of the level of … protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5”.

 

It is true that situation (a) does not speak of Articles 5.1 through 5.8. Nevertheless, two points need to be noted. First, the last sentence of Article 3.3 requires that “all measures which result in a [higher] level of … protection”, that is to say, measures falling within situation (a) as well as those falling within situation (b), be “not inconsistent with any other provision of [the SPS] Agreement”. “Any other provision of this Agreement” textually includes Article 5. Secondly, the footnote to Article 3.3, while attached to the end of the first sentence, defines “scientific justification” as an “examination and evaluation of available scientific information in conformity with relevant provisions of this Agreement … ”. This examination and evaluation would appear to partake of the nature of the risk assessment required in Article 5.1 and defined in paragraph 4 of Annex A of the SPS Agreement.

 

S.6.8.5 EC — Hormones, para. 177
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… the Panel’s finding that the European Communities is required by Article 3.3 to comply with the requirements of Article 5.1 is correct …

 

S.6.8.6 US — Continued Suspension / Canada — Continued Suspension, para. 532
(WT/DS320/AB/R, WT/DS321/AB/R)

 

… While use of international standards is encouraged, the SPS Agreement recognizes the right of WTO Members to introduce or maintain an SPS measure which results in a higher level of protection than would be achieved by measures based on such international standards. Where a Member exercises its right to adopt an SPS measure that results in a higher level of protection, that right is qualified in that the SPS measure must comply with the other requirements of the SPS Agreement, including the requirement to perform a risk assessment. However, the Appellate Body has found that the adoption of an SPS measure that does not conform to an international standard and results in a higher level of protection does not give rise to a more exacting burden of proof under the SPS Agreement. …

 

S.6.8.7 US — Continued Suspension / Canada — Continued Suspension, para. 534
(WT/DS320/AB/R, WT/DS321/AB/R)

 

The risk assessment cannot be entirely isolated from the appropriate level of protection. There may be circumstances in which the appropriate level of protection chosen by a Member affects the scope or method of the risk assessment. This may be the case where a WTO Member decides not to adopt an SPS measure based on an international standard because it seeks to achieve a higher level of protection. In such a situation, the fact that the WTO Member has chosen to set a higher level of protection may require it to perform certain research as part of its risk assessment that is different from the parameters considered and the research carried out in the risk assessment underlying the international standard. However, the chosen level of protection must not affect the rigour or objective nature of the risk assessment, which must remain, in its essence, a process in which possible adverse effects are evaluated using scientific methods. Likewise, whatever the level of protection a Member chooses does not pre-determine the results of the risk assessment. Otherwise, the purpose of performing the risk assessment would be defeated.

 

S.6.8.8 US — Continued Suspension / Canada — Continued Suspension, paras. 685-686
(WT/DS320/AB/R, WT/DS321/AB/R)

 

A WTO Member that adopts an SPS measure resulting in a higher level of protection than would be achieved by measures based on international standards must nevertheless ensure that its SPS measure complies with the other requirements of the SPS Agreement, in particular Article 5. This includes the requirement to perform a risk assessment. At the same time, we recognize that, in order to perform a risk assessment, a WTO Member may need scientific information that was not examined in the process leading to the adoption of the international standard. We see no basis in Articles 3.3 and 5.1 of the SPS Agreement to conclude that WTO Members choosing a higher level of protection than would be achieved by a measure based on an international standard must frame the scope and methods of its risk assessment, including the scientific information to be examined, in the same manner as the international body that performed the risk assessment underlying the international standard. Thus, where the chosen level of protection is higher than would be achieved by a measure based on an international standard, this may have some bearing on the scope or method of the risk assessment. In such a situation, the fact that the WTO Member has chosen to set a higher level of protection may require it to perform certain research as part of its risk assessment that is different from the parameters considered and the research carried out in the risk assessment underlying the international standard.

 

For these reasons, we disagree with the Panel’s finding that “the determination of whether scientific evidence is sufficient to assess the existence and magnitude of a risk must be disconnected from the intended level of protection”. We emphasize, however, that whatever level of protection a WTO Member chooses does not pre-determine the outcome of its determination of the sufficiency of the relevant scientific evidence. The determination as to whether available scientific evidence is sufficient to perform a risk assessment must remain, in essence, a rigorous and objective process.

 

S.6.8.9 US — Continued Suspension / Canada — Continued Suspension, para. 694
(WT/DS320/AB/R, WT/DS321/AB/R)

 

It is therefore undisputed that JECFA has performed risk assessments for the six hormones at issue and that Codex has adopted international standards for five of these hormones on the basis of JECFA’s risk assessments. The fact that JECFA has performed risk assessments for all six hormones means that the relevant scientific evidence was in its estimation sufficient to do so. Article 3.2 provides that SPS measures which conform to international standards shall be deemed necessary to protect human, animal or plant life or health, and shall be presumed to be consistent with the relevant provisions of the SPS Agreement and of the GATT 1994. This presumption, however, does not apply where a Member has not adopted a measure that conforms with an international standard. Article 3.2 is inapplicable where a Member chooses a level of protection that is higher than would be achieved by a measure based on an international standard. The presumption in Article 3.2 cannot be interpreted to imply that there is sufficient scientific evidence to perform a risk assessment where a Member chooses a higher level of protection.

 
S.6.9 Article 5.1 and Annex A, paragraph 4 — Concept of risk assessment     back to top

S.6.9.1 EC — Hormones, para. 177
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… The requirements of a risk assessment under Article 5.1, as well as of “sufficient scientific evidence” under Article 2.2, are essential for the maintenance of the carefully negotiated balance achieved in the SPS Agreement between the shared, but sometimes competing, interests of promoting international trade and protecting the health of human beings. …

 

S.6.9.2 EC — Hormones, para. 180
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… the Panel considered that Article 5.1 may be viewed as a specific application of the basic obligations contained in Article 2.2 of the SPS Agreement …

 

… We agree with this general consideration and would also stress that Articles 2.2 and 5.1 should constantly be read together. Article 2.2 informs Article 5.1: the elements that define the basic obligation set out in Article 2.2 impart meaning to Article 5.1.

 

S.6.9.3 EC — Hormones, para. 181
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… We must stress … that Article 5 and Annex A of the SPS Agreement speak of “risk assessment” only and that the term “risk management” is not to be found either in Article 5 or in any other provision of the SPS Agreement. Thus, the Panel’s distinction, which it apparently employs to achieve or support what appears to be a restrictive notion of risk assessment, has no textual basis. …

 

S.6.9.4 EC — Hormones, paras. 183-184
(WT/DS26/AB/R, WT/DS48/AB/R)

 

Interpreting [paragraph 4 of Annex A of the SPS Agreement], the Panel elaborates risk assessment as a two-step process that “should (i) 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 … , and (ii) if any such adverse effects exist, evaluate the potential or probability of occurrence of such effects”.

 

… Although the utility of a two-step analysis may be debated, it does not appear to us to be substantially wrong. What needs to be pointed out at this stage is that the Panel’s use of “probability” as an alternative term for “potential” creates a significant concern. The ordinary meaning of “potential” relates to “possibility” and is different from the ordinary meaning of “probability”. “Probability” implies a higher degree or a threshold of potentiality or possibility. It thus appears that here the Panel introduces a quantitative dimension to the notion of risk.

 

S.6.9.5 EC — Hormones, para. 190
(WT/DS26/AB/R, WT/DS48/AB/R)

 

Article 5.1 does not insist that a Member that adopts a sanitary measure shall have carried out its own risk assessment. It only requires that the SPS measures be “based on an assessment, as appropriate for the circumstances … ”. The SPS measure might well find its objective justification in a risk assessment carried out by another Member, or an international organization. …

 

S.6.9.6 US — Continued Suspension / Canada — Continued Suspension, para. 527
(WT/DS320/AB/R, WT/DS321/AB/R)

 

… In EC — Hormones, the panel described a “risk assessment” as a “scientific process aimed at establishing the scientific basis” for the SPS measure. The Appellate Body understood the panel to refer to “a process characterized by systematic, disciplined and objective enquiry and analysis, that is, a mode of studying and sorting out facts and opinions”. Science therefore plays a central role in a risk assessment. However, the Appellate Body has cautioned against taking too narrow an approach to a risk assessment …

 

S.6.9.7 US — Continued Suspension / Canada — Continued Suspension, para. 530
(WT/DS320/AB/R, WT/DS321/AB/R)

 

An SPS measure need not be based on a risk assessment performed by the WTO Member taking the measure. It can be based on a risk assessment performed by a relevant international organization or by another WTO Member. …

 

S.6.9.8 US — Continued Suspension / Canada — Continued Suspension, paras. 534-535
(WT/DS320/AB/R, WT/DS321/AB/R)

 

The risk assessment cannot be entirely isolated from the appropriate level of protection. There may be circumstances in which the appropriate level of protection chosen by a Member affects the scope or method of the risk assessment. This may be the case where a WTO Member decides not to adopt an SPS measure based on an international standard because it seeks to achieve a higher level of protection. In such a situation, the fact that the WTO Member has chosen to set a higher level of protection may require it to perform certain research as part of its risk assessment that is different from the parameters considered and the research carried out in the risk assessment underlying the international standard. However, the chosen level of protection must not affect the rigour or objective nature of the risk assessment, which must remain, in its essence, a process in which possible adverse effects are evaluated using scientific methods. Likewise, whatever the level of protection a Member chooses does not pre-determine the results of the risk assessment. Otherwise, the purpose of performing the risk assessment would be defeated.

 

We understand that Codex draws a distinction between “risk assessment” and “risk management”. It defines “risk management” as “the process, distinct from risk assessment, of weighing policy alternatives … considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options”. In EC — Hormones, the Appellate Body noted that the SPS Agreement does not refer to the concept of “risk management” and it rejected the panel’s restrictive interpretation of a “risk assessment” based on that distinction. The Appellate Body has not provided a clear demarcation of the factors that may be considered in a “risk assessment” under the SPS Agreement, but it has held that the list of factors provided in Article 5.2 is not a closed list and, in particular, that abuse or misuse and difficulties of control in the administration of hormones may be considered in the context of a risk assessment.

 

S.6.9.9 US — Continued Suspension / Canada — Continued Suspension, paras. 541-542
(WT/DS320/AB/R, WT/DS321/AB/R)

 

We find it difficult to reconcile the Panel’s understanding of EC — Hormones with what the Appellate Body held in that Report. As we noted above, in that case, the Appellate Body rejected the rigid distinction drawn by the panel between “risk assessment” and “risk management”, explaining:

 

We must stress, in this connection, that Article 5 and Annex A of the SPS Agreement speak of “risk assessment” only and that the term “risk management” is not to be found either in Article 5 or in any other provision of the SPS Agreement. Thus, the Panel’s distinction, which it apparently employs to achieve or support what appears to be a restrictive notion of risk assessment, has no textual basis.

 

Subsequently in the same Report, the Appellate Body reiterated its view that “the concept of ‘risk management’ is not mentioned in any provision of the SPS Agreement and, as such, cannot be used to sustain a more restrictive interpretation of ‘risk assessment’ than is justified by the actual terms of Article 5.2, Article 8 and Annex C of the SPS Agreement”.

 

Therefore, in our view, the Panel’s interpretation of “risk assessment” resulted in the same “restrictive notion of risk assessment” that the Appellate Body found to be erroneous in EC — Hormones. The Panel sought in this case to rewrite the Appellate Body Report in EC — Hormones and to re-establish the rigid distinction between “risk assessment” and “risk management” that the Appellate Body had rejected in that case.

 

S.6.9.10 US — Continued Suspension / Canada — Continued Suspension, para. 591
(WT/DS320/AB/R, WT/DS321/AB/R)

 

The Appellate Body has observed that a WTO Member may properly base an SPS measure on divergent or minority views, as long as these views are from qualified and respected sources. This must be taken into account in defining a panel’s standard of review. Accordingly, a panel reviewing the consistency of an SPS measure with Article 5.1 of the SPS Agreement must, first, identify the scientific basis upon which the SPS measure was adopted. This scientific basis need not reflect the majority view within the scientific community but may reflect divergent or minority views. Having identified the scientific basis underlying the SPS measure, the panel must then verify that the scientific basis comes from a respected and qualified source. Although the scientific basis need not represent the majority view within the scientific community, it must nevertheless have the necessary scientific and methodological rigour to be considered reputable science. In other words, while the correctness of the views need not have been accepted by the broader scientific community, the views must be considered to be legitimate science according to the standards of the relevant scientific community. A panel should also assess whether the reasoning articulated on the basis of the scientific evidence is objective and coherent. In other words, a panel should review whether the particular conclusions drawn by the Member assessing the risk find sufficient support in the scientific evidence relied upon. Finally, the panel must determine whether the results of the risk assessment “sufficiently warrant” the SPS measure at issue. Here, again, the scientific basis cited as warranting the SPS measure need not reflect the majority view of the scientific community provided that it comes from a qualified and respected source.

 
S.6.10 Article 5.1 — Ascertainable risk     back to top

S.6.10.1 EC — Hormones, para. 186
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… In one part of its Reports, the Panel opposes a requirement of an “identifiable risk” to the uncertainty that theoretically always remains since science can never provide absolute certainty that a given substance will not ever have adverse health effects. We agree with the Panel that this theoretical uncertainty is not the kind of risk which, under Article 5.1, is to be assessed. …

 

S.6.10.2 EC — Hormones, para. 187
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… It is essential to bear in mind that the risk that is to be evaluated in a risk assessment under Article 5.1 is not only risk ascertainable in a science laboratory operating under strictly controlled conditions, but also risk in human societies as they actually exist, in other words, the actual potential for adverse effects on human health in the real world where people live and work and die.

 

S.6.10.3 Australia — Salmon, para. 125
(WT/DS18/AB/R)

 

… As stated in our Report in European Communities Hormones, the “risk” evaluated in a risk assessment must be an ascertainable risk; theoretical uncertainty is “not the kind of risk which, under Article 5.1, is to be assessed”. This does not mean, however, that a Member cannot determine its own appropriate level of protection to be “zero risk”.

 

S.6.10.4 Japan — Apples, para. 241
(WT/DS245/AB/R)

 

The comments of the Panel in response to the argument of the United States on “theoretical risk” should be viewed in their appropriate context. In EC — Hormones, the Appellate Body referred to the notion of “theoretical uncertainty” in the context of Article 5.1 of the SPS Agreement. The Appellate Body indicated that Article 5.1 does not address theoretical uncertainty, that is to say, “uncertainty that theoretically always remains since science can never provide absolute certainty that a given substance will not ever have adverse health effects” [Appellate Body Report, para. 186]. We understand that the “scientific prudence” displayed by the experts in this case related to the risks that might arise from radical changes in Japan’s current system of phytosanitary controls, taking into account Japan’s island environment and climate. The scientific prudence displayed by the experts did not relate to the “theoretical uncertainty” that is inherent in the scientific method and which stems from the intrinsic limits of experiments, methodologies, or instruments deployed by scientists to explain a given phenomenon. Therefore, we agree with the Panel that the scientific prudence displayed by the experts should not be “completely assimilated” to the “theoretical uncertainty” that the Appellate Body discussed in EC — Hormones as being beyond the purview of risks to be addressed by measures subject to the SPS Agreement.

 

S.6.10.5 US — Continued Suspension / Canada — Continued Suspension, para. 531
(WT/DS320/AB/R, WT/DS321/AB/R)

 

Whilst WTO Members have the right to take SPS measures, they are not required to do so. The risk assessment may conclude that there is no ascertainable risk, in which case no SPS measure can be taken. Alternatively, a WTO Member may conclude that an SPS measure is not necessary in the light of the risks determined in the risk assessment and the acceptable level of protection determined by that WTO Member.

 
S.6.11 Article 5.1 — Types of risk assessment     back to top

S.6.11.1 Australia — Salmon, para. 121
(WT/DS18/AB/R)

 

… in this case a risk assessment within the meaning of Article 5.1 must:

 

(1) identify the diseases whose entry, establishment or spread a Member wants to prevent within its territory, as well as the potential biological and economic consequences associated with the entry, establishment or spread of these diseases;

 

(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 or spread of these diseases according to the SPS measures which might be applied.

 
S.6.12 Article 5.1 — Degree of risk     back to top

S.6.12.1 Australia — Salmon, footnote 69 to para. 123
(WT/DS18/AB/R)

 

We note that the first type of risk assessment in paragraph 4 of Annex A is substantially different from the second type of risk assessment contained in the same paragraph. While the second requires only the evaluation of the potential for adverse effects on human or animal health, the first type of risk assessment demands an evaluation of the likelihood of entry, establishment or spread of a disease, and of the associated potential biological and economic consequences. In view of the very different language used in paragraph 4 of Annex A for the two types of risk assessment, we do not believe that it is correct to diminish the substantial differences between these two types of risk assessments …

 

S.6.12.2 Australia — Salmon, para. 123
(WT/DS18/AB/R)

 

… for a risk assessment to fall within the meaning of Article 5.1 and the first definition in paragraph 4 of Annex A, it is not sufficient that a risk assessment conclude that there is a possibility of entry, establishment or spread of diseases and associated biological and economic consequences. A proper risk assessment of this type must evaluate the “likelihood”, i.e., the “probability”, of entry, establishment or spread of diseases and associated biological and economic consequences as well as the “likelihood”, i.e., “probability”, of entry, establishment or spread of diseases according to the SPS measures which might be applied.

 

S.6.12.3 Australia — Salmon, para. 124
(WT/DS18/AB/R)

 

… We do not agree with the Panel that a risk assessment of this type needs only some evaluation of the likelihood or probability. The definition of this type of risk assessment in paragraph 4 of Annex A refers to “the evaluation of the likelihood” and not to some evaluation of the likelihood. We agree, however, … that the SPS Agreement does not require that the evaluation of the likelihood needs to be done quantitatively. The likelihood may be expressed either quantitatively or qualitatively … there is no requirement for a risk assessment to establish a certain magnitude or threshold level of degree of risk.

 

S.6.12.4 Japan — Apples, para. 208
(WT/DS245/AB/R)

 

The definition of “risk assessment” in the SPS Agreement requires that the evaluation of the entry, establishment or spread of a disease be conducted “according to the sanitary or phytosanitary measures which might be applied”. We agree with the Panel that this phrase “refers to the measures which might be applied, not merely to the measures which are being applied”. The phrase “which might be applied” is used in the conditional tense. In this sense, “might” means: “were or would be or have been able to, were or would be or have been allowed to, were or would perhaps”. We understand this phrase to imply that a risk assessment should not be limited to an examination of the measure already in place or favoured by the importing Member. In other words, the evaluation contemplated in paragraph 4 of Annex A to the SPS Agreement should not be distorted by preconceived views on the nature and the content of the measure to be taken; nor should it develop into an exercise tailored to and carried out for the purpose of justifying decisions ex post facto.

 

S.6.12.5 US — Continued Suspension / Canada — Continued Suspension, para. 530
(WT/DS320/AB/R, WT/DS321/AB/R)

 

… The risk assessment can be quantitative or qualitative in nature. …

 

S.6.12.6 US — Continued Suspension / Canada — Continued Suspension, paras. 569, 572, 574 and footnote 1176
(WT/DS320/AB/R, WT/DS321/AB/R)

 

Although the definition of a risk assessment does not require WTO Members to establish a minimum magnitude of risk, it is nevertheless difficult to understand the concept of risk as being devoid of any indication of potentiality. A risk assessment is intended to identify adverse effects and evaluate the possibility that such adverse effects might arise. This distinguishes an ascertainable risk from theoretical uncertainty. However, the assessment of risk need not be expressed in numerical terms or as a minimum quantification of the level of risk. We are also mindful that the risk assessment at issue in this case concerns the potential for adverse effects under the second sentence of paragraph 4 of Annex A and not an evaluation of likelihood under the first sentence of paragraph 4.1176

 

 

As the European Communities acknowledges, “a quantitative dimension may not be immediately evident from the ordinary meaning of the words ‘potential occurrence’ ”. The terms “potential occurrence of adverse effects” can be understood as referring to the possibility that the adverse effects might occur, without necessarily requiring that this be expressed in numerical terms. This would be consistent with the definition of “risk assessment” in paragraph 4 of Annex A of the SPS Agreement, as interpreted by the Appellate Body. Moreover, it would be consistent with the Appellate Body’s view that “theoretical uncertainty” is not the kind of risk to be assessed under Article 5.1, but rather the risk to be assessed must be an “ascertainable” risk. In this sense, we agree with Canada that “to examine the ‘potential’ for adverse effects is to ask whether those adverse effects could ever occur”.

 

 

… However, we recall that a “risk assessment” involves an indication of potentiality, even though this need not be expressed in numerical terms or as a minimum quantification of the level of risk. In this sense, the Panel’s reference to “magnitude” is in our view not sufficient to establish that the Panel incorrectly interpreted Article 5.1 and paragraph 4 of Annex A as requiring a quantitative risk assessment.

 
S.6.13 Articles 5.1 and 5.2 — Risk assessment — Specific to the risk identified     back to top

S.6.13.1 EC — Hormones, para. 199
(WT/DS26/AB/R, WT/DS48/AB/R)

 

The European Communities laid particular emphasis on the 1987 IARC Monographs and the articles and opinions of individual scientists referred to above. The Panel notes, however, that the scientific evidence set out in these Monographs and these articles and opinions relates to the carcinogenic potential of entire categories of hormones, or of the hormones at issue in general. The Monographs and the articles and opinions are, in other words, in the nature of general studies of or statements on the carcinogenic potential of the named hormones. The Monographs and the articles and opinions of individual scientists have not evaluated the carcinogenic potential of those hormones when used specifically for growth promotion purposes. Moreover, they do not evaluate the specific potential for carcinogenic effects arising from the presence in “food”, more specifically, “meat or meat products” of residues of the hormones in dispute. The Panel also notes that, according to the scientific experts advising the Panel, the data and studies set out in these 1987 Monographs have been taken into account in the 1988 and 1989 JECFA Reports and that the conclusions reached by the 1987 IARC Monographs are complementary to, rather than contradictory of, the conclusions of the JECFA Reports. The Panel concludes that these Monographs and these articles and opinions are insufficient to support the EC measures at issue in this case.

 

S.6.13.2 EC — Hormones, para. 206
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… The SPS Agreement requires assessment of the potential for adverse effects on human health arising from the presence of contaminants and toxins in food. We consider that the object and purpose of the SPS Agreement justify the examination and evaluation of all such risks for human health whatever their precise and immediate origin may be. We do not mean to suggest that risks arising from potential abuse in the administration of controlled substances and from control problems need to be, or should be, evaluated by risk assessors in each and every case. When and if risks of these types do in fact arise, risk assessors may examine and evaluate them. Clearly, the necessity or propriety of examination and evaluation of such risks would have to be addressed on a case-by-case basis. What, in our view, is a fundamental legal error is to exclude, on an a priori basis, any such risks from the scope of application of Articles 5.1 and 5.2. …

 

S.6.13.3 Japan — Apples, para. 202 and footnote 372
(WT/DS245/AB/R)

 

… Under the SPS Agreement, the obligation to conduct an assessment of “risk” is not satisfied merely by a general discussion of the disease sought to be avoided by the imposition of a phytosanitary measure.372 The Appellate Body found the risk assessment at issue in EC — Hormones not to be “sufficiently specific” even though the scientific articles cited by the importing Member had evaluated the “carcinogenic potential of entire categories of hormones, or of the hormones at issue in general”. In order to constitute a “risk assessment” as defined in the SPS Agreement, the Appellate Body concluded, the risk assessment should have reviewed the carcinogenic potential, not of the relevant hormones in general, but of “residues of those hormones found in meat derived from cattle to which the hormones had been administered for growth promotion purposes”. Therefore, when discussing the risk to be specified in the risk assessment in EC — Hormones, the Appellate Body referred in general to the harm concerned (cancer or genetic damage) as well as to the precise agent that may possibly cause the harm (that is, the specific hormones when used in a specific manner and for specific purposes).

 

S.6.13.4 Japan — Apples, para. 203 and footnote 379
(WT/DS245/AB/R)

 

In this case, the Panel found that the conclusion of the 1999 PRA with respect to fire blight was “based on an overall assessment of possible modes of contamination, where apple fruit is only one of the possible hosts/vectors considered”. The Panel further found, on the basis of the scientific evidence, that the risk of entry, establishment or spread of the disease varies significantly depending on the vector, or specific host plant, being evaluated. Given that the measure at issue relates to the risk of transmission of fire blight through apple fruit, in an evaluation of whether the risk assessment is “sufficiently specific to the case at hand”, the nature of the risk addressed by the measure at issue is a factor to be taken into account. In the light of these considerations, we are of the view that the Panel properly determined that the 1999 PRA “evaluat[ion of] the risks associated with all possible hosts taken together” was not sufficiently specific to qualify as a “risk assessment” under the SPS Agreement for the evaluation of the likelihood of entry, establishment or spread of fire blight in Japan through apple fruit.379

 

S.6.13.5 US — Continued Suspension / Canada — Continued Suspension, para. 530
(WT/DS320/AB/R, WT/DS321/AB/R)

 

… the risk assessment must have the requisite degree of specificity. The assessment must be “sufficiently specific” in terms of the harm concerned and the precise agent that may possibly cause the harm.

 

S.6.13.6 US — Continued Suspension / Canada — Continued Suspension, para. 547
(WT/DS320/AB/R, WT/DS321/AB/R)

 

… Although the Panel does not seem to reject a priori the relevance of the potential risks of misuse or abuse, it then states that it was not necessary to address this question in its analysis, to the extent that it did not have an impact on the issues addressed by the Panel under Article 5.1. However, some of the scientific experts consulted by the Panel indicated that risks arising from residues of oestradiol-17β in bovine meat are likely to increase where good veterinary practices in the administration of this hormone are not followed. Indeed, these experts agreed that their conclusions in relation to the risks posed by oestradiol-17β were predicated on good veterinary practices being followed. Accordingly, the abuse or misuse in the administration of oestradiol-17β has a bearing on the particular risks being assessed by the European Communities. The Panel’s conclusion was thus premature because the Panel could not have decided whether the European Communities failed to evaluate specifically the possible adverse effects of residues of oestradiol-17β in meat before considering the evidence on abuse or misuse. The Panel’s summary dismissal of the relevance of the evidence on misuse or abuse at the interim review stage gives the appearance of being an ex post rationalization of an earlier decision to exclude such risks from consideration.

 

S.6.13.7 US — Continued Suspension / Canada — Continued Suspension, paras. 552-553
(WT/DS320/AB/R, WT/DS321/AB/R)

 

As noted earlier, the relevance of abuse or misuse in the administration of the hormones at issue was recognized by the Appellate Body in EC — Hormones. The Appellate Body observed that, “[w]here the condition of observance of good veterinary practice (which is much the same condition attached to the standards, guidelines and recommendations of Codex with respect to the use of the five hormones for growth promotion) is not followed, the logical inference is that the use of such hormones for growth promotion purposes may or may not be ‘safe’.”

 

The Panel does not address the evidence on misuse or abuse referred to in the 1999 and 2002 Opinions in its analysis under Article 5.1 of the SPS Agreement. Neither does the Panel discuss the testimony of the scientific experts that recognized the relevance of this evidence and the potential adverse effects of the misuse or abuse in the administration of the hormones. The Panel summarily dismissed the relevance of the evidence on misuse or abuse stating that it relates to exposure assessment and adding that it is not necessary to address it given the finding that the European Communities had not evaluated specifically the possibility that the adverse effects arise from the consumption of meat from cattle treated with oestradiol-17β for growth-promotion purposes. We recognize that the 1999 Opinion examines the risks of misuse or abuse under the heading “Exposure considerations upon misuse”. After discussing the evidence on misuse and abuse, the 2002 Opinion states that “these data have to be considered in any quantitative exposure assessment exercise”. This, however, cannot justify the Panel’s failure to address the evidence on misuse or abuse. The European Communities made it clear that the risks of abuse or misuse were a relevant consideration in its risk assessment. This is confirmed in the 1999 and 2002 Opinions. At least two of the scientific experts consulted by the Panel recognized that the misuse or abuse in the administration of the hormones could give rise to adverse effects. The Panel had a duty to engage with this evidence and with the discussion of this evidence in the SCVPH Opinions. By summarily dismissing the evidence on the misuse or abuse in the administration of the hormones and the consequent conclusions in the SCVPH Opinions in the manner that it did, the Panel incorrectly applied Article 5.1 and the definition of “risk assessment” in Annex A of the SPS Agreement, as interpreted by the Appellate Body.

 

S.6.13.8 US — Continued Suspension / Canada — Continued Suspension, paras. 559, 562-563
(WT/DS320/AB/R, WT/DS321/AB/R)

 

The definition of a risk assessment in paragraph 4 of Annex A, as interpreted by the Appellate Body, required the European Communities to conduct a risk assessment that addresses the specific risk at issue. The particular risk being evaluated by the European Communities in this case was the potential for neurobiological, developmental, reproductive, and immunological effects, as well as immunotoxic, genotoxic and carcinogenic effects from the residues of oestradiol-17β found in meat derived from cattle to which this hormone was administered for growth-promoting purposes. Although the European Communities is correct in arguing that it was not required to demonstrate that these adverse health effects would actually arise, it was nevertheless required to demonstrate that these adverse effects could arise from the presence of residues of oestradiol-17β in meat from treated cattle. In our view, this is what the Panel required when it examined whether the European Communities had “evaluate[d] the possibility that the identified adverse effect … resulted from the presence of residues of oestradiol-17β in meat or meat products as a result of the cattle being treated with the hormone for growth promoting purposes”.

 

 

The particular risk being assessed by the European Communities is the possibility of adverse health effects from the consumption of residues of oestradiol-17β in meat treated with this hormone for growth promotion. In EC — Hormones, the Appellate Body required evaluation of “the carcinogenic or genotoxic potential of the residues of [the] hormones” at issue found in meat from treated cattle. In this case, the European Communities had to evaluate whether a causal connection exists between the consumption of meat from cattle treated with oestradiol-17β and the possibility of adverse health effects. This does not mean that the European Communities was required to establish a direct causal relationship between the possibility of adverse health effects and the residues of oestradiol-17β in bovine meat. In order to meet the requirements of Article 5.1 and Annex A of the SPS Agreement, it was sufficient for the European Communities to demonstrate that the additional human exposure to residues of oestradiol-17β in meat from treated cattle is one of the factors contributing to the possible adverse health effects. The European Communities was not required to isolate the contribution made by residues of oestradiol-17β in meat from cattle treated with the hormone for growth promotion from the contributions made by other sources. Where multiple factors may contribute to a particular risk, a risk assessor is not required to differentiate the individual contribution made by each factor. Article 5.1 requires that SPS measures be based on a risk assessment “as appropriate to the circumstances”, which suggests that the scientific inquiry involved in a risk assessment must take due account of particular methodological difficulties posed by the nature and characteristics of the particular substance and risk being evaluated. However, that does not excuse the risk assessor from evaluating whether there is a connection between the particular substance being evaluated and the possibility that adverse health effects may arise.

 

… we are not persuaded by the European Communities suggestion that the Panel required testing in humans in order to specifically evaluate the risks associated with the consumption of meat from cattle treated with oestradiol-17β. We do not see this as a necessary implication of the Panel’s analysis. There is no indication in the Panel Report to suggest that the evaluation could not proceed on the basis of experimentation in laboratory animals and extrapolating the results to humans, or by other means. Certainly, where a substance may be potentially toxic, requiring a WTO Member to evaluate specifically the risks through actual human consumption of the substance would be unethical and would not be “appropriate to the circumstances” within the meaning of Article 5.1.

 
S.6.14 Article 5.1 — Requirement to base measure on the risk assessment     back to top

S.6.14.1 EC — Hormones, para. 186
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… To the extent that the Panel purported to require a risk assessment to establish a minimum magnitude of risk, we must note that imposition of such a quantitative requirement finds no basis in the SPS Agreement. A panel is authorized only to determine whether a given SPS measure is “based on” a risk assessment. …

 

S.6.14.2 EC — Hormones, para. 193
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… We believe that Article 5.1, when contextually read as it should be, in conjunction with and as informed by Article 2.2 of the SPS Agreement, requires that the results of the risk assessment must sufficiently warrant — that is to say, reasonably support — the SPS measure at stake. The requirement that an SPS measure be “based on” a risk assessment is a substantive requirement that there be a rational relationship between the measure and the risk assessment.

 

S.6.14.3 Japan — Agricultural Products II, para. 84
(WT/DS76/AB/R)

 

… we agree with the Panel that the obligation in Article 2.2 that an SPS measure not be maintained without sufficient scientific evidence requires that there be a rational or objective relationship between the SPS measure and the scientific evidence. Whether there is a rational relationship between an SPS measure and the scientific evidence is to be determined on a case-by-case basis and will depend upon the particular circumstances of the case, including the characteristics of the measure at issue and the quality and quantity of the scientific evidence.

 

S.6.14.4 EC — Hormones, para. 194
(WT/DS26/AB/R, WT/DS48/AB/R)

 

We do not believe that a risk assessment has to come to a monolithic conclusion that coincides with the scientific conclusion or view implicit in the SPS measure. The risk assessment could set out both the prevailing view representing the “mainstream” of scientific opinion, as well as the opinions of scientists taking a divergent view. Article 5.1 does not require that the risk assessment must necessarily embody only the view of a majority of the relevant scientific community … In most cases, responsible and representative governments tend to base their legislative and administrative measures on “mainstream” scientific opinion. In other cases, equally responsible and representative governments may act in good faith on the basis of what, at a given time, may be a divergent opinion coming from qualified and respected sources. By itself, this does not necessarily signal the absence of a reasonable relationship between the SPS measure and the risk assessment, especially where the risk involved is life-threatening in character and is perceived to constitute a clear and imminent threat to public health and safety. Determination of the presence or absence of that relationship can only be done on a case-to-case basis, after account is taken of all considerations rationally bearing upon the issue of potential adverse health effects.

 

S.6.14.5 Japan — Apples, para. 215
(WT/DS245/AB/R)

 

As Japan failed to establish that the Panel utilized subsequent scientific evidence in evaluating the risk assessment at issue, it is not necessary for us to express views on the question whether the conformity of a risk assessment with Article 5.1 should be evaluated solely against the scientific evidence available at the time of the risk assessment, to the exclusion of subsequent information. Resolution of such hypothetical claims would not serve “to secure a positive solution” to this dispute.

 
S.6.15 Article 5.5 — Consistency in the application of the appropriate level of protection     back to top

S.6.15.1 EC — Hormones, para. 213
(WT/DS26/AB/R, WT/DS48/AB/R)

 

The objective of Article 5.5 is formulated as the “achieving [of] consistency in the application of the concept of appropriate level of sanitary or phytosanitary protection”. Clearly, the desired consistency is defined as a goal to be achieved in the future … Thus, we agree with the Panel’s view that the statement of that goal does not establish a legal obligation of consistency of appropriate levels of protection. We think, too, that the goal set is not absolute or perfect consistency, since governments establish their appropriate levels of protection frequently on an ad hoc basis and over time, as different risks present themselves at different times. It is only arbitrary or unjustifiable inconsistencies that are to be avoided.

 

S.6.15.2 EC — Hormones, paras. 214-215
(WT/DS26/AB/R, WT/DS48/AB/R)

 

Close inspection of Article 5.5 indicates that a complaint of violation of this Article must show the presence of three distinct elements. The first element is that the Member imposing the measure complained of has adopted its own appropriate levels of sanitary protection against risks to human life or health in several different situations. The second element to be shown is that those levels of protection exhibit arbitrary or unjustifiable differences (“distinctions” in the language of Article 5.5) in their treatment of different situations. The last element requires that the arbitrary or unjustifiable differences result in discrimination or a disguised restriction of international trade. We understand the last element to be referring to the measure embodying or implementing a particular level of protection as resulting, in its application, in discrimination or a disguised restriction on international trade.

 

We consider the above three elements of Article 5.5 to be cumulative in nature; all of them must be demonstrated to be present if violation of Article 5.5 is to be found. In particular, both the second and third elements must be found. The second element alone would not suffice. The third element must also be demonstrably present: the implementing measure must be shown to be applied in such a manner as to result in discrimination or a disguised restriction on international trade. The presence of the second element — the arbitrary or unjustifiable character of differences in levels of protection considered by a Member as appropriate in differing situations — may in practical effect operate as a “warning” signal that the implementing measure in its application might be a discriminatory measure or might be a restriction on international trade disguised as an SPS measure for the protection of human life or health. Nevertheless, the measure itself needs to be examined and appraised and, in the context of the differing levels of protection, shown to result in discrimination or a disguised restriction on international trade.

 
S.6.16 Article 5.5 — Distinctions in the level of protection in different situations     back to top

S.6.16.1 EC — Hormones, para. 217
(WT/DS26/AB/R, WT/DS48/AB/R)

 

… The situations exhibiting differing levels of protection cannot, of course, be compared unless they are comparable, that is, unless they present some common element or elements sufficient to render them comparable. If the situations proposed to be examined are totally different from one another, they would not be rationally comparable and the differences in levels of protection cannot be examined for arbitrariness.

 

S.6.16.2 Australia — Salmon, para. 146
(WT/DS18/AB/R)

 

… the Panel was correct in stating that situations can be compared under Article 5.5 if these situations involve either a risk of entry, establishment or spread of the same or a similar disease, or a risk of the same or similar “associated potential biological and economic consequences”.

 

S.6.16.3 Australia — Salmon, para. 152
(WT/DS18/AB/R)

 

… we believe that for situations to be comparable under Article 5.5, it is sufficient for these situations to have in common a risk of entry, establishment or spread of one disease of concern. There is no need for these situations to have in common a risk of entry, establishment or spread of all diseases of concern. …

 
S.6.17 Article 5.5 — “result in discrimination or a disguised restriction”     back to top

S.6.17.1 EC — Hormones, para. 212
(WT/DS26/AB/R, WT/DS48/AB/R)

 

Article 5.5 must be read in context. An important part of that context is Article 2.3 of the SPS Agreement, which provides as follows:

 

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.

 

When read together with Article 2.3, Article 5.5 may be seen to be marking out and elaborating a particular route leading to the same destination set out in Article 2.3.

 

S.6.17.2 EC — Hormones, para. 238
(WT/DS26/AB/R, WT/DS48/AB/R)

 

We agree with the Panel’s view that “all three elements [of Article 5.5] need to be distinguished and addressed separately”. We also recall our interpretation that Article 5.5 and, in particular, the terms “discrimination or a disguised restriction on international trade”, have to be read in the context of the basic obligations contained in Article 2.3, which requires that “sanitary … measures shall not be applied in a manner which would constitute a disguised restriction on international trade” (emphasis added).

 

S.6.17.3 EC — Hormones, para. 240
(WT/DS26/AB/R, WT/DS48/AB/R)

 

In our view, the degree of difference, or the extent of the discrepancy, in the levels of protection, is only one kind of factor which, along with others, may cumulatively lead to the conclusion that discrimination or a disguised restriction on international trade in fact results from the application of a measure or measures embodying one or more of those different levels of protection … It is well to bear in mind that, after all, the difference in levels of protection that is characterizable as arbitrary or unjustifiable is only an element of (indirect) proof that a Member may actually be applying an SPS measure in a manner that discriminates between Members or constitutes a disguised restriction on international trade, prohibited by the basic obligations set out in Article 2.3 of the SPS Agreement.

 

S.6.17.4 EC — Hormones, para. 246
(WT/DS26/AB/R, WT/DS48/AB/R)

 

Our conclusion, therefore, is that the Panel’s finding that the “arbitrary or unjustifiable” difference in the EC levels of protection in respect of the hormones at issue on the one hand and in respect of carbadox and olaquindox on the other hand, “result in discrimination or a disguised restriction on international trade”, is not supported either by the architecture and structure of the EC Directives here at stake or of the subsequent Directive on carbadox and olaquindox, or by the evidence submitted by the United States and Canada to the Panel. …

 

S.6.17.5 Australia — Salmon, para. 164
(WT/DS18/AB/R)

 

… in this case the degree of difference in the levels of protection (prohibition versus tolerance) is indeed, as the Panel stated, “rather substantial”. We, therefore, consider it legitimate to treat this difference as a separate warning signal.

 

S.6.17.6 Australia — Salmon, para. 166
(WT/DS18/AB/R)

 

… We note that a finding that an SPS measure is not based on an assessment of the risks to human, animal or plant life or health — either because there was no risk assessment at all or because there is an insufficient risk assessment — is a strong indication that this measure is not really concerned with the protection of human, animal or plant life or health but is instead a trade-restrictive measure taken in the guise of an SPS measure, i.e., a “disguised restriction on international trade”. We, therefore, consider that the finding of inconsistency with Article 5.1 is an appropriate warning signal for a “disguised restriction on international trade”.

 
S.6.18 Article 5.6 — Not more trade restrictive than required to achieve the appropriate level of protection     back to top

S.6.18.1 Australia — Salmon, para. 194
(WT/DS18/AB/R)

 

We agree with the Panel that Article 5.6 and, in particular, the footnote to this provision, clearly provides a three-pronged test to establish a violation of Article 5.6. As already noted, the three elements of this test under Article 5.6 are that there is an SPS measure which:

 

(1) is reasonably available taking into account technical and economic feasibility;

 

(2) achieves the Member’s appropriate level of sanitary or phytosanitary protection; and

 

(3) is significantly less restrictive to trade than the SPS measure contested. These three elements are cumulative in the sense that, to establish inconsistency with Article 5.6, all of them have to be met. If any of these elements is not fulfilled, the measure in dispute would be consistent with Article 5.6. …

 

S.6.18.2 Japan — Agricultural Products II, para. 95
(WT/DS76/AB/R)

 

Article 5.6 of the SPS Agreement prohibits SPS measures that are more trade-restrictive than required to achieve a Member’s appropriate level of protection. According to the footnote to Article 5.6, a measure is considered more trade-restrictive than required if there is another SPS measure which:

 

(1) is reasonably available taking into account technical and economic feasibility;

 

(2) achieves the Member’s appropriate level of sanitary or phytosanitary protection; and

 

(3) is significantly less restrictive to trade than the SPS measure contested. As we have stated in our Report in Australia Salmon, these three elements are cumulative in nature.

 
S.6.19 Article 5.7 — Provisional adoption of SPS measures     back to top

S.6.19.1 Japan — Agricultural Products II, para. 80
(WT/DS76/AB/R)

 

… Article 5.7 allows Members to adopt provisional SPS measures “[i]n cases where relevant scientific evidence is insufficient” and certain other requirements are fulfilled. Article 5.7 operates as a qualified exemption from the obligation under Article 2.2 not to maintain SPS measures without sufficient scientific evidence. An overly broad and flexible interpretation of that obligation would render Article 5.7 meaningless.

 

S.6.19.2 Japan — Agricultural Products II, para. 89
(WT/DS76/AB/R)

 

Article 5.7 of the SPS Agreement sets out four requirements which must be met in order to adopt and maintain a provisional SPS measure. Pursuant to the first sentence of Article 5.7, a Member may provisionally adopt an SPS measure if this measure is:

 

(1) imposed in respect of a situation where “relevant scientific information is insufficient”; and

 

(2) adopted “on the basis of available pertinent information”.

 

Pursuant to the second sentence of Article 5.7, such a provisional measure may not be maintained unless the Member which adopted the measure:

 

(1) “seek[s] to obtain the additional information necessary for a more objective assessment of risk”; and

 

(2) “review[s] the … measure accordingly within a reasonable period of time”.

 

These four requirements are clearly cumulative in nature and are equally important for the purpose of determining consistency with this provision. Whenever one of these four requirements is not met, the measure at issue is inconsistent with Article 5.7.

 

S.6.19.3 Japan — Agricultural Products II, para. 91
(WT/DS76/AB/R)

 

We, therefore, conclude that the Panel did not err in its application of Article 5.7 by first examining whether the varietal testing requirement meets the requirements of the second sentence of Article 5.7. Having established that the requirements of the second sentence of Article 5.7 are not met, there was no need for the Panel to examine the requirements of the first sentence.

 

S.6.19.4 US — Continued Suspension / Canada — Continued Suspension, paras. 676, 679 and footnote 1398
(WT/DS320/AB/R, WT/DS321/AB/R)

 

The Appellate Body has explained that Article 5.7 sets out four obligations. Two of these obligations set conditions that must be met before a provisional SPS measure is adopted. The other two obligations are conditions for maintaining the provisional SPS measure once it has been taken. These four obligations are:

 

(1) [the measure is] imposed in respect of a situation where “relevant scientific information is insufficient”;

 

(2) [the measure is] adopted “on the basis of available pertinent information”;

 

(3) [the Member that adopted the measure] “seek[s] to obtain the additional information necessary for a more objective assessment of risk”; and

 

(4) [the Member that adopted the measure] “review[s] the … measure accordingly within a reasonable period of time”.

 

 

The second sentence of Article 5.7 requires that the available pertinent information which provides a basis for a Member’s provisional SPS measure be supplemented with “the additional information necessary for a more objective assessment of risk” within a “reasonable period of time”. As the Appellate Body noted, these two conditions “relate to the maintenance of a provisional [SPS] measure and highlight the provisional nature of measures adopted pursuant to Article 5.7”. The requirement that the WTO Member “shall seek to obtain the additional information necessary for a more objective assessment of risk” implies that, as of the adoption of the provisional measure, a WTO Member must make best efforts to remedy the insufficiencies in the relevant scientific evidence with additional scientific research or by gathering information from relevant international organizations or other sources.1398 Otherwise, the provisional nature of measures taken pursuant to Article 5.7 would lose meaning. The “insufficiency” of the scientific evidence is not a perennial state, but rather a transitory one, which lasts only until such time as the imposing Member procures the additional scientific evidence which allows the performance of a more objective assessment of risk. The Appellate Body has noted that Article 5.7 does not set out “explicit prerequisites regarding the additional information to be collected or a specific collection procedure”. Nevertheless, the WTO Member adopting a provisional SPS measure should be able to identify the insufficiencies in the relevant scientific evidence, and the steps that it intends to take to obtain the additional information that will be necessary to address these deficiencies in order to make a more objective assessment and review the provisional measure within a reasonable period of time. The additional information to be collected must be “germane” to conducting the assessment of the specific risk. A Member is required under Article 5.7 to seek to obtain additional information but is not expected to guarantee specific results. Nor is it expected to predict the actual results of its efforts to collect additional information at the time when it adopts the SPS measure. …

 
S.6.20 Article 5.7 — “where relevant scientific evidence is insufficient”     back to top

S.6.20.1 Japan — Apples, para. 179
(WT/DS245/AB/R)

 

… The first requirement of Article 5.7 is that there must be insufficient scientific evidence. When a panel reviews a measure claimed by a Member to be provisional, that panel must assess whether “relevant scientific evidence is insufficient”. This evaluation must be carried out, not in the abstract, but in the light of a particular inquiry. The notions of “relevance” and “insufficiency” in the introductory phrase of Article 5.7 imply a relationship between the scientific evidence and something else. Reading this introductory phrase in the broader context of Article 5 of the SPS Agreement, which is entitled “Assessment of Risk and Determination of the Appropriate Level of Sanitary or Phytosanitary Protection”, is instructive in ascertaining the nature of the relationship to be established. Article 5.1 sets out a key discipline under Article 5, namely that “Members shall ensure that their sanitary or phytosanitary measures are based on an assessment … of the risks to human, animal or plant life or health”. This discipline informs the other provisions of Article 5, including Article 5.7.We note, as well, that the second sentence of Article 5.7 refers to a “more objective assessment of risks”. These contextual elements militate in favour of a link or relationship between the first requirement under Article 5.7 and the obligation to perform a risk assessment under Article 5.1: “relevant scientific evidence” will be “insufficient” within the meaning of Article 5.7 if the body of available scientific evidence does not allow, in quantitative or qualitative terms, the performance of an adequate assessment of risks as required under Article 5.1 and as defined in Annex A to the SPS Agreement. Thus, the question is not whether there is sufficient evidence of a general nature or whether there is sufficient evidence related to a specific aspect of a phytosanitary problem, or a specific risk. The question is whether the relevant evidence, be it “general” or “specific”, in the Panel’s parlance, is sufficient to permit the evaluation of the likelihood of entry, establishment or spread of, in this case, fire blight in Japan.

 

S.6.20.2 Japan — Apples, para. 184
(WT/DS245/AB/R)

 

… The application of Article 5.7 is triggered not by the existence of scientific uncertainty, but rather by the insufficiency of scientific evidence. The text of Article 5.7 is clear: it refers to “cases where relevant scientific evidence is insufficient”, not to “scientific uncertainty”. The two concepts are not interchangeable. Therefore, we are unable to endorse Japan’s approach of interpreting Article 5.7 through the prism of “scientific uncertainty”.

 

S.6.20.3 US — Continued Suspension / Canada — Continued Suspension, paras. 674, 677
(WT/DS320/AB/R, WT/DS321/AB/R)

 

Under Article 2.2 of the SPS Agreement, WTO Members are required to “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”. This requirement is made operative in other provisions of the SPS Agreement, including Article 5.1, which requires SPS measures to be “based on” a risk assessment. At the same time, Article 2.2 excludes from its scope of application situations in which the relevant scientific evidence is insufficient. In such situations, the applicable provision is Article 5.7 of the SPS Agreement. Thus, the applicability of Articles 2.2 and 5.1, on the one hand, and of Article 5.7, on the other hand, will depend on the sufficiency of the scientific evidence. The Appellate Body has explained that the relevant scientific evidence will be considered “insufficient” for purposes of Article 5.7 “if the body of available scientific evidence does not allow, in quantitative or qualitative terms, the performance of an adequate assessment of risks as required under Article 5.1 and as defined in Annex A to the SPS Agreement”. This means that where the relevant scientific evidence is sufficient to perform a risk assessment, as defined in Annex A of the SPS Agreement, a WTO Member may take an SPS measure only if it is “based on” a risk assessment in accordance with Article 5.1 and that SPS measure is also subject to the obligations in Article 2.2. If the relevant scientific evidence is insufficient to perform a risk assessment, a WTO Member may take a provisional SPS measure on the basis provided in Article 5.7, but that Member must meet the obligations set out in that provision.

 

 

Article 5.7 begins with the requirement that the “relevant scientific evidence” be “insufficient”. As explained earlier, the relevant scientific evidence is “insufficient” where “the body of available scientific evidence does not allow, in quantitative or qualitative terms, the performance of an adequate assessment of risks as required under Article 5.1 and as defined in Annex A to the SPS Agreement”. Under Article 5.1, WTO Members are allowed to base SPS measures on divergent or minority views provided they are from a respected and qualified source. Thus the existence of scientific controversy in itself is not enough to conclude that the relevant scientific evidence is “insufficient”. It may be possible to perform a risk assessment that meets the requirements of Article 5.1 even when there are divergent views in the scientific community in relation to a particular risk. By contrast, Article 5.7 is concerned with situations where deficiencies in the body of scientific evidence do not allow a WTO Member to arrive at a sufficiently objective conclusion in relation to risk. When determining whether such deficiencies exist, a Member must not exclude from consideration relevant scientific evidence from any qualified and respected source. Where there is, among other opinions, a qualified and respected scientific view that puts into question the relationship between the relevant scientific evidence and the conclusions in relation to risk, thereby not permitting the performance of a sufficiently objective assessment of risk on the basis of the existing scientific evidence, then a Member may adopt provisional measures under Article 5.7 on the basis of that qualified and respected view.

 

S.6.20.4 US — Continued Suspension / Canada — Continued Suspension, para. 681
(WT/DS320/AB/R, WT/DS321/AB/R)

 

The European Communities argues that SPS measures are either “based on” a risk assessment under Article 5.1, or otherwise the relevant scientific evidence will be “insufficient” within the meaning of Article 5.7, so that provisional SPS measures may be justified. We do not agree. There may be situations where the relevant scientific evidence is sufficient to perform a risk assessment, a WTO Member performs such a risk assessment, but does not adopt an SPS measure either because the risk assessment did not confirm the risk, or the risk identified did not exceed that Member’s chosen level of protection. Also, there may be situations where there is no pertinent scientific information available indicating a risk such that an SPS measure would be unwarranted even on a provisional basis.

 

S.6.20.5 US — Continued Suspension / Canada — Continued Suspension, paras. 694-697
(WT/DS320/AB/R, WT/DS321/AB/R)

 

It is therefore undisputed that JECFA has performed risk assessments for the six hormones at issue and that Codex has adopted international standards for five of these hormones on the basis of JECFA’s risk assessments. The fact that JECFA has performed risk assessments for all six hormones means that the relevant scientific evidence was in its estimation sufficient to do so. Article 3.2 provides that SPS measures which conform to international standards shall be deemed necessary to protect human, animal or plant life or health, and shall be presumed to be consistent with the relevant provisions of the SPS Agreement and of the GATT 1994. This presumption, however, does not apply where a Member has not adopted a measure that conforms with an international standard. Article 3.2 is inapplicable where a Member chooses a level of protection that is higher than would be achieved by a measure based on an international standard. The presumption in Article 3.2 cannot be interpreted to imply that there is sufficient scientific evidence to perform a risk assessment where a Member chooses a higher level of protection.

 

This is borne out by Article 5.7, which provides that WTO Members may adopt provisional SPS 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”. There is no indication in Article 5.7 that a WTO Member may not take a provisional SPS measure wherever a relevant international organization or another Member has performed a risk assessment. Information from relevant international organizations may not necessarily be considered “sufficient” to perform a risk assessment, as it may be part of the “available pertinent information” which provides the basis for a provisional SPS measure under Article 5.7. Moreover, scientific evidence that may have been relied upon by an international body when performing the risk assessment that led to the adoption of an international standard at a certain point in time may no longer be valid, or may become insufficient in the light of subsequent scientific developments. Therefore, the existence of a risk assessment performed by JECFA does not mean that scientific evidence underlying it must be considered to be sufficient within the meaning of Article 5.7.

 

In our view, it is reasonable for a WTO Member challenging the consistency with Article 5.7 of a provisional SPS measure adopted by another Member to submit JECFA’s risk assessments and supporting studies leading to the adoption of international standards as evidence that the scientific evidence is not insufficient to perform a risk assessment. However, such evidence is not dispositive and may be rebutted by the Member taking the provisional SPS measure.

 

The European Communities argues that the Panel considered the existence of international standards as establishing an “irrebuttable presumption” that the relevant scientific evidence in this case is not “insufficient” for the purposes of Article 5.7. As we pointed out above, the existence of an international standard does not create a legal presumption of sufficiency for purposes of Article 5.7. The Panel recognized that “[i]t cannot be excluded that new scientific evidence or information call into question existing evidence”, and acknowledged the possibility that “different risk assessments reach different interpretations of the same scientific evidence”. The Panel examined the specific points raised by the European Communities concerning the insufficiencies it saw in the scientific evidence considered in JECFA’s risk assessment. There would not have been a need for the Panel to undertake such an assessment if it had considered that the existence of international standards established an irrebuttable presumption that the relevant scientific evidence was not insufficient within the meaning of Article 5.7. Thus we find no fault with the Panel to the extent that it treated the evidence underlying JECFA’s risk assessment as having probative value for determining whether the relevant scientific evidence was insufficient. In our view, the existence of risk assessments conducted by JECFA in relation to the five hormones at issue has probative value, but is not dispositive, of the question of whether the relevant scientific evidence on those hormones is “insufficient” within the meaning of Article 5.7.

 

S.6.20.6 US — Continued Suspension / Canada — Continued Suspension, paras. 701-703, 705
(WT/DS320/AB/R, WT/DS321/AB/R)

 

We agree that scientific progress may lead a WTO Member and international organizations to reconsider the risk assessment underlying an SPS measure. In some cases, new scientific developments will permit a WTO Member to conduct a new risk assessment with the sufficient degree of objectivity. There may be situations, however, where the new scientific developments themselves do not permit the performance of a new risk assessment that is sufficiently objective. Such a situation would fall within the scope of Article 5.7 of the SPS Agreement.

 

The Appellate Body has explained that “ ‘relevant scientific evidence’ will be ‘insufficient’ within the meaning of Article 5.7 if the body of available scientific evidence does not allow, in quantitative or qualitative terms, the performance of an adequate assessment of risks as required under Article 5.1 and as defined in Annex A to the SPS Agreement”. The body of scientific evidence underlying a risk assessment can always be supplemented with additional information. Indeed, the nature of scientific inquiry is such that it is always possible to conduct more research or obtain additional information. The possibility of conducting further research or of analysing additional information, by itself, should not mean that the relevant scientific evidence is or becomes insufficient.

 

Moreover, as the Panel noted, science continuously evolves. It may be useful to think of the degree of change as a spectrum. On one extreme of this spectrum lies the incremental advance of science. Where these scientific advances are at the margins, they would not support the conclusion that previously sufficient evidence has become insufficient. At the other extreme lie the more radical scientific changes that lead to a paradigm shift. Such radical change is not frequent. Limiting the application of Article 5.7 to situations where scientific advances lead to a paradigm shift would be too inflexible an approach. WTO Members should be permitted to take a provisional measure where new evidence from a qualified and respected source puts into question the relationship between the pre-existing body of scientific evidence and the conclusions regarding the risks. We are referring to circumstances where new scientific evidence casts doubts as to whether the previously existing body of scientific evidence still permits of a sufficiently objective assessment of risk.

 

 

The Panel’s statement that “there must be a critical mass of new evidence and/or information that calls into question the fundamental precepts of previous knowledge and evidence so as to make relevant, previously sufficient, evidence now insufficient” could be understood as requiring that the new scientific evidence lead to a paradigm shift. As we have said, such an approach is too inflexible. Although the new evidence must call into question the relationship between the body of scientific evidence and the conclusions concerning risk, it need not rise to the level of a paradigm shift.

 

S.6.20.7 US — Continued Suspension / Canada — Continued Suspension, paras. 708, 710-711
(WT/DS320/AB/R, WT/DS321/AB/R)

 

We earlier observed that the existence of an international standard for which a risk assessment was conducted could be offered as evidence in support of an assertion that the relevant scientific evidence is not insufficient within the meaning of Article 5.7 of the SPS Agreement. It is an evidentiary issue in the sense that the scientific information underlying the international standard has probative value as to the sufficiency of the scientific evidence needed for conducting a risk assessment at a discrete point in time. However, in circumstances where a Member adopts a higher level of protection than that reflected in the international standard, the legal test that applies to the “insufficiency” of the evidence under Article 5.7 is not made stricter. Thus, it is incorrect to use JECFA’s risk assessments as a legal benchmark for assessing insufficiency as the Panel did in this case.

 

 

We recall that the presumption in Article 3.2 is inapplicable where a WTO Member adopts an SPS measure that results in a higher level of protection than that reflected in an international standard. For this reason, Article 3.2 did not provide a basis for the Panel’s use of the JECFA risk assessments as the legal benchmark against which the insufficiencies in the relevant scientific evidence identified by the European Communities had to be evaluated. …

 

The particular insufficiencies in the relevant scientific evidence identified by the European Communities had to be evaluated on their own terms. As indicated earlier, the scientific evidence underlying the risk assessments conducted by JECFA has probative value as to the sufficiency of the scientific evidence needed to perform an assessment of risks in relation to the five hormones; however, it was by no means dispositive of that question, in particular where a WTO Member has elected to adopt an SPS measure that does not conform to the international standard.

 

S.6.20.8 US — Continued Suspension / Canada — Continued Suspension, paras. 721, 725-726
(WT/DS320/AB/R, WT/DS321/AB/R)

 

… the Panel’s “critical mass” test imposed an excessively high threshold in terms of the change in the scientific evidence that would make previously sufficient evidence insufficient. Rather than requiring that the new evidence call into question the relationship between the body of scientific evidence and the conclusions concerning risk, the Panel’s test required a paradigm shift to the extent the evidence needed to call into question the “fundamental precepts of previous knowledge and evidence” on the five hormones. This erroneous threshold led the Panel to fail to attribute significance to evidence that could cast doubt as to whether the relevant scientific evidence still permits of a sufficiently objective assessment of risk. One such example is the Panel’s analysis of the European Communities’ contention that the relevant scientific evidence concerning the effects of the hormones on certain categories of the population, in particular pre-pubertal children, was “insufficient” within the meaning of Article 5.7 of the SPS Agreement.

 

 

In concluding that it is “not convinced” that the ultra-sensitive assay study referred to by the European Communities “call[s] into question the fundamental precepts of previous knowledge” in relation to the effect of the five hormones on pre-pubertal children, the Panel applied an excessively high threshold in relation to the new scientific evidence which is required to render previously sufficient scientific evidence “insufficient” within the meaning of Article 5.7. Irrespective of whether the Panel was itself persuaded by the Klein study, the Panel erred to the extent that it considered that a paradigmatic shift in the scientific knowledge was required in order to render the scientific evidence relied on by JECFA now “insufficient” within the meaning of Article 5.7. The “insufficiency” requirement in Article 5.7 does not imply that new scientific evidence must entirely displace the scientific evidence upon which an international standard relies. It suffices that new scientific developments call into question whether the body of scientific evidence still permits of a sufficiently objective assessment of risk.

 

The Panel seemed to rely on two pieces of evidence in coming to the conclusion that the ultra-sensitive detection method discussed in the Klein study had not yet been validated: a statement to that effect in the 2002 Opinion, and the testimony of Dr Boobis, who questioned the validity of the Klein study. However, the Panel record shows that at least some of the scientific experts considered that the Klein study could possibly cast doubt as to whether the body of scientific evidence relied on by JECFA still permitted of a sufficiently objective assessment of risks posed by the five hormones in relation to pre-pubertal children.

 
S.6.20A Article 5.7 — “on the basis of available, pertinent information”     back to top

S.6.20A.1 US — Continued Suspension / Canada — Continued Suspension, para. 678
(WT/DS320/AB/R, WT/DS321/AB/R)

 

WTO Members’ right to take provisional measures in circumstances where the relevant scientific information is “insufficient” is also subject to the requirement that such measures be adopted “on the basis of available pertinent information”. Such information may include information from “the relevant international organizations” or deriving from SPS measures applied by other WTO Members. Thus, Article 5.7 contemplates situations where there is some evidentiary basis indicating the possible existence of a risk, but not enough to permit the performance of a risk assessment. Moreover, there must be a rational and objective relationship between the information concerning a certain risk and a Member’s provisional SPS measure. In this sense, Article 5.7 provides a “temporary ‘safety valve’ in situations where some evidence of a risk exists but not enough to complete a full risk assessment, thus making it impossible to meet the more rigorous standards set by Articles 2.2 and 5.1”.

 
S.6.21 Article 5.7 — “seek to obtain additional information”     back to top

S.6.21.1 Japan — Agricultural Products II, para. 92
(WT/DS76/AB/R)

 

… we note that the first part of the second sentence stipulates that the Member adopting a provisional SPS measure “shall seek to obtain the additional information necessary for a more objective assessment of risk”. Neither Article 5.7 nor any other provision of the SPS Agreement sets out explicit prerequisites regarding the additional information to be collected or a specific collection procedure. Furthermore, Article 5.7 does not specify what actual results must be achieved; the obligation is to “seek to obtain” additional information. However, Article 5.7 states that the additional information is to be sought in order to allow the Member to conduct “a more objective assessment of risk”. Therefore, the information sought must be germane to conducting such a risk assessment, i.e., the evaluation of the likelihood of entry, establishment or spread of, in casu, a pest, according to the SPS measures which might be applied. …

 

S.6.21.2 US — Continued Suspension / Canada — Continued Suspension, para. 679 and footnote 1398
(WT/DS320/AB/R, WT/DS321/AB/R)

 

The second sentence of Article 5.7 requires that the available pertinent information which provides a basis for a Member’s provisional SPS measure be supplemented with “the additional information necessary for a more objective assessment of risk” within a “reasonable period of time”. As the Appellate Body noted, these two conditions “relate to the maintenance of a provisional [SPS] measure and highlight the provisional nature of measures adopted pursuant to Article 5.7”. The requirement that the WTO Member “shall seek to obtain the additional information necessary for a more objective assessment of risk” implies that, as of the adoption of the provisional measure, a WTO Member must make best efforts to remedy the insufficiencies in the relevant scientific evidence with additional scientific research or by gathering information from relevant international organizations or other sources.1398 Otherwise, the provisional nature of measures taken pursuant to Article 5.7 would lose meaning. The “insufficiency” of the scientific evidence is not a perennial state, but rather a transitory one, which lasts only until such time as the imposing Member procures the additional scientific evidence which allows the performance of a more objective assessment of risk. The Appellate Body has noted that Article 5.7 does not set out “explicit prerequisites regarding the additional information to be collected or a specific collection procedure”. Nevertheless, the WTO Member adopting a provisional SPS measure should be able to identify the insufficiencies in the relevant scientific evidence, and the steps that it intends to take to obtain the additional information that will be necessary to address these deficiencies in order to make a more objective assessment and review the provisional measure within a reasonable period of time. The additional information to be collected must be “germane” to conducting the assessment of the specific risk. A Member is required under Article 5.7 to seek to obtain additional information but is not expected to guarantee specific results. Nor is it expected to predict the actual results of its efforts to collect additional information at the time when it adopts the SPS measure. …

 
S.6.22 Article 5.7 — “review… within a reasonable period of time”     back to top

S.6.22.1 Japan — Agricultural Products II, para. 93
(WT/DS76/AB/R)

 

… In our view, what constitutes a “reasonable period of time” has to be established on a case-by-case basis and depends on the specific circumstances of each case, including the difficulty of obtaining the additional information necessary for the review and the characteristics of the provisional SPS measure. …

 
S.6.23 Article 5.7 — Precautionary principle     back to top

S.6.23.1 EC — Hormones, paras. 123-125
(WT/DS26/AB/R, WT/DS48/AB/R)

 

The status of the precautionary principle in international law continues to be the subject of debate among academics, law practitioners, regulators and judges. The precautionary principle is regarded by some as having crystallized into a general principle of customary international environmental law. Whether it has been widely accepted by Members as a principle of general or customary international law appears less than clear. We consider, however, that it is unnecessary, and probably imprudent, for the Appellate Body in this appeal to take a position on this important, but abstract, question. We note that the Panel itself did not make any definitive finding with regard to the status of the precautionary principle in international law and that the precautionary principle, at least outside the field of international environmental law, still awaits authoritative formulation.

 

It appears to us important, nevertheless, to note some aspects of the relationship of the precautionary principle to the SPS Agreement. First, the principle has not been written into the SPS Agreement as a ground for justifying SPS measures that are otherwise inconsistent with the obligations of Members set out in particular provisions of that Agreement. Secondly, the precautionary principle indeed finds reflection in Article 5.7 of the SPS Agreement. We agree, at the same time, with the European Communities, that there is no need to assume that Article 5.7 exhausts the relevance of a precautionary principle. It is reflected also in the sixth paragraph of the preamble and in Article 3.3. These explicitly recognize the right of Members to establish their own appropriate level of sanitary protection, which level may be higher (i.e., more cautious) than that implied in existing international standards, guidelines and recommendations. Thirdly, a panel charged with determining, for instance, whether “sufficient scientific evidence” exists to warrant the maintenance by a Member of a particular SPS measure may, of course, and should, bear in mind that responsible, representative governments commonly act from perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to human health are concerned. Lastly, however, the precautionary principle does not, by itself, and without a clear textual directive to that effect, relieve a panel from the duty of applying the normal (i.e. customary international law) principles of treaty interpretation in reading the provisions of the SPS Agreement.

 

We accordingly agree with the finding of the Panel that the precautionary principle does not override the provisions of Articles 5.1 and 5.2 of the SPS Agreement.

 

S.6.23.2 US — Continued Suspension / Canada — Continued Suspension, para. 680
(WT/DS320/AB/R, WT/DS321/AB/R)

 

These four conditions set out in Article 5.7, however, must be interpreted keeping in mind that the precautionary principle finds reflection in this provision. … In emergency situations, for example, a WTO Member will take a provisional SPS measure on the basis of limited information and the steps it takes to comply with its obligations to seek to obtain additional information and review the measure will be assessed in the light of the exigencies of the emergency.

 
S.6.24 Annex B on “Transparency of SPS Regulations”, paragraph 1 — “publication of laws, decrees or ordinances”     back to top

S.6.24.1 Japan — Agricultural Products II, paras. 105-106
(WT/DS76/AB/R)

 

We consider that the list of instruments contained in the footnote to paragraph 1 of Annex B is, as is indicated by the words “such as”, not exhaustive in nature. The scope of application of the publication requirement is not limited to “laws, decrees or ordinances”, but also includes, in our opinion, other instruments which are applicable generally and are similar in character to the instruments explicitly referred to in the illustrative list of the footnote to paragraph 1 of Annex B.

 

The object and purpose of paragraph 1 of Annex B is “to enable interested Members to become acquainted with” the sanitary and phytosanitary regulations adopted or maintained by other Members and thus to enhance transparency regarding these measures. In our opinion, the scope of application of the publication requirement of paragraph 1 of Annex B should be interpreted in the light of the object and purpose of this provision.

 

1176. The Appellate Body found in EC — Hormones that the term “potential” in the second sentence of paragraph 4 of Annex A refers to the “possibility” of occurrence of adverse effects, which implies a lower degree of potentiality than “probability” (Appellate Body Report, EC — Hormones, para. 184).     back to text

372. Indeed, we are of the view that, as a general matter, “risk” cannot usually be understood only in terms of the disease or adverse effects that may result. Rather, an evaluation of risk must connect the possibility of adverse effects with an antecedent or cause. For example, the abstract reference to the “risk of cancer” has no significance, in and of itself, under the SPS Agreement; but when one refers to the “risk of cancer from smoking cigarettes”, the particular risk is given content.     back to text

379. We note our understanding that the Panel did not base its finding on, nor make any reference to, whether the SPS Agreement requires a risk assessment to analyse the importation of products on a country-specific basis. Neither participant in this appeal has asked us to find that the definition of “risk assessment” in the SPS Agreement mandates an analysis of risk specific to each country of exportation. As a result, we make no findings with respect to whether such a country-specific analysis is required in order to satisfy a Member’s obligations under Article 5.1 of the SPS Agreement.     back to text

1398. Pursuant to Article 10.1 of the SPS Agreement, due account shall be taken of the special needs of developing country Members in respect of their ability to procure the additional information for a more objective assessment of risk.     back to text


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