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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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