Transcript SPS

The SPS Agreement
and its provisions relating to
scientific evidence
WTO
Slide 1
Three “SPS Disputes”
“Hormones”
EC - Measures Concerning Meat and Meat Products (Hormones)
“Salmon”
Australia - Measures Affecting Importation of Salmon
“Varietals”
Japan - Measures Affecting Agricultural Products
WTO
Slide 2
“science”
Basic Rights and
Obligations
(Article 2)
Harmonization
(Article 3)
Int’l org.
(Article 12:3)
Expert advice
(Article 11:2)
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Risk Assessment
(Article 5)
Slide 3
Basic Rights and Obligations
(Article 2)
Article 2.1
“Members have the right to take sanitary and phytosanitary
measures necessary for the protection of human, animal or plant
life or health, provided that such measures are not inconsistent
with the provisions of this Agreement”
WTO
Slide 4
Basic Rights and Obligations
(Article 2)
Article 2.2
“Members shall ensure that any sanitary or phytosanitary
measure is applied only to the extent necessary to protect
human, animal or plant life or health, is based on scientific
principles and is not maintained without sufficient scientific
evidence, except as provided for in paragraph 7 of Article 5.”
WTO
Slide 5
Basic Rights and Obligations
Article 2.2
applied only to the extent necessary to
protect human, animal or plant life or
health
shall ensure:
is based on scientific principles
is not maintained without sufficient
scientific evidence
except as provided for in paragraph 7 of Article 5.
WTO
Slide 6
Article 2:2
(Basic Rights and Obligations)
Hormones
Salmon
Varietals
focus on risk assessment
(Article 5)
WTO
Slide 7
Article 2:2
(Basic Rights and Obligations)
Panel - Varietals
“In our view, for a phytosanitary measure to be ‘maintained
without’ sufficient scientific evidence, there needs to be a
lack of an objective relationship between, on the one hand,
the phytosanitary measure at stake (in casu, the varietal
testing requirement) and, on the other hand, the scientific
evidence submitted before the Panel (in casu, in particular
the six studies referred to by Japan)”.
Japan -Varietals, Panel Report, para. 8.29.
WTO
Slide 8
Article 2:2
(Basic Rights and Obligations)
Panel - Varietals
The Panel reviewed the parties’ submissions and the advice from
the scientific experts (entomology, fumigation) and concluded:
“it has not been sufficiently demonstrated that there is a rational
relationship between the varietal testing requirement and the
scientific evidence submitted to the Panel”
Japan -Varietals, Panel Report, para. 8.42
WTO
Slide 9
Basic Rights and Obligations
Article 2.2
applied only to the extent necessary to
protect human, animal or plant life or
health
shall ensure:
is based on scientific principles
is not maintained without sufficient
scientific evidence
except as provided for in paragraph 7 of Article 5
WTO
Slide 10
Article 2:2
(Basic Rights and Obligations)
Panel - Varietals
“lack of an objective relationship”
“measure”
“the scientific evidence submitted before the Panel”
 Article 2.2 (?)
WTO
Slide 11
Article 2:2
(Basic Rights and Obligations)
AB - Varietals
Upheld.
(with respect to apples, cherries, nectarines and walnuts)
Japan -Varietals, AB, para. 85.
WTO
Slide 12
What about the exception
to the rule of basing SPS measures
on science? (Article 5.7)
Article 2.2
Article 5.7
“Article 5.7 operates as a qualified exemption from the
obligation under Article 2.2 to maintain SPS measures
without sufficient scientific evidence.”
Varietals, AB Report, para. 80
WTO
Slide 13
Basic Rights and Obligations
Article 2.2
applied only to the extent necessary to
protect human, animal or plant life or
health
shall ensure:
is based on scientific principles
is not maintained without sufficient
scientific evidence
except as provided for in paragraph 7 of Article 5
WTO
Slide 14
Where scientific evidence is insufficient
(Article 5.7)
SPS Agreement, Article 5.7
“In cases where relevant scientific evidence is insufficient, a
Member may provisionally adopt sanitary or phytosanitary
measures on the basis of available pertinent information,
including that from the relevant international organizations as
well as from sanitary or phytosanitary measures applied by
other Members. In such circumstances, Members shall seek
to obtain the additional information necessary for a more
objective assessment of risk and review the sanitary or
phytosanitary measure accordingly within a reasonable
period of time.”
WTO
Slide 15
Article 5:7
“qualified exemption”
Panel - Varietals
• Japan specifically invoked 5:7. It claimed that that its
measure could be considered a provisional measure
• The Panel found that four cumulative elements needed to
be shown for a measure to be consistent with Article 5.7.
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Slide 16
Article 5:7
“qualified exemption”
Panel - Varietals
Allowed to provisionally adopt a measure if:
1
and
2
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the measure is imposed in respect of a situation
where “relevant” scientific information is
insufficient;
the measure is adopted “on the basis of
available pertinent information”
Slide 17
Article 5:7
“qualified exemption”
Panel - Varietals
+ additional obligations:
3
and
4
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“seek to obtain the additional information
necessary for a more objective assessment of
risk”; and,
“review the … phytosanitary measure
accordingly within a reasonable period of
time”.
Slide 18
Article 5:7
“qualified exemption”
Panel - Varietals
• Panel examined only the third and fourth
elements
…….
…….
– no evidence that Japan had sought to obtain
information necessary for a more objective
assessment of the risk…
– ... and reviewed the measure accordingly within a
reasonable period of time
 Article 5.7
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…….
…….
 Article 2.2
Slide 19
Article 5:7
“qualified exemption”
AB - Varietals
• Upheld.
– Confirmed that four requirements are cumulative
– Agreed with the Panel that Japan had not sought to
obtain additional information
– Noted that the “reasonable period of time” had to be
established on a case-by-case basis
WTO
Slide 20
Article 5:7
“qualified exemption”
Panel - Hormones
• The EC did not invoke Article 5.7, it was explicitly stated that the
import prohibition was not a provisional measure.
• The EC invoked the “precautionary principle” as a general
principle of law and argued that Articles 5.1 and 5.2 did not
prevent Members from being cautious when setting health
standards in the face of conflicting scientific evidence and
uncertainty.
WTO
Slide 21
Article 5:7
“qualified exemption”
AB - Hormones
• Did not take a position on the status of the precautionary principle
in international law.
• Noted that the precautionary principle “found reflection in Article
5.7 of the SPS Agreement”.
• Agreed with the finding of the Panel that the precautionary
principle - to the extent it is not explicitly incorporated in Article
5.7 - did not override the provisions of Article 5.1 and 5.2 of the
SPS Agreement.
WTO
Slide 22
Article 5 - Risk Assessment
“Assessment of Risk and Determination of the Appropriate Level of
Sanitary or Phytosanitary Protection”
Article 2.2
Article 5
Article 5.1-5.3
risk assessment
Article 5.5
consistency
Article 5.7
insufficient
scientific ...
WTO
Slide 23
Risk Assessment
(Article 5.1 - 5.3)
Article 5.1
“Members shall ensure that their sanitary or phytosanitary
measures are based on an assessment, as appropriate to the
circumstances, of the risks to human, animal or plant life or
health, taking into account risk assessment techniques
developed by the relevant international organizations.”
WTO
Slide 24
Risk Assessment
(Article 5.1 - 5.3)
Article 5.2
“In the assessment of risks, Members shall take into account
available scientific evidence; relevant processes and
production methods; relevant inspection, sampling and testing
methods; prevalence of specific diseases or pests; existence of
pest- or disease-free areas; relevant ecological and
environmental conditions; and quarantine or other treatment”
WTO
Slide 25
Risk Assessment
(Article 5.1 - 5.3)
Article 5.3
“In assessing the risk to animal or plant life or health and
determining the measure to be applied for achieving the
appropriate level of sanitary or phytosanitary protection from
such risk, Members shall take into account as relevant
economic factors: the potential damage in terms of loss of
production or sales in the event of the entry, establishment or
spread of a pest or disease; the costs of control or eradication
in the territory of the importing Member; and the relative
cost-effectiveness of alternative approaches to limiting risks.”
WTO
Slide 26
Risk Assessment
(Article 5.1 - 5.3)
Article 5.1
Article 5.2
Article 5.3
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• measure has to be based on a
risk assessment
• what to take into account
(available scientific
evidence, etc.)
• for animal and plant health,
what economic factors to
take into account
Slide 27
Article 5.1-5.3
risk assessment
Focus on 2.2
“scientific evidence”
Hormones
Salmon
food safety
animal health
(5.1-5.2)
(5.1-5.3)
WTO
Varietals
Slide 28
Article 5.1-5.2
risk assessment
Panel - Hormones
The definition of a risk assessment for food-borne risks
• "the evaluation of the potential for adverse effects on human
or animal health arising from the presence of additives,
contaminants, toxins or disease-causing organisms in food,
beverages or feedstuffs".
–
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SPS Agreement, Annex A, Paragraph 4, second sentence
Slide 29
Article 5.1-5.2
risk assessment
Panel - Hormones
WTO
1
“identify the adverse effects on human health (if any)
arising from the presence of the hormones at issue
when used as growth promoters in meat or meat
products, and
2
“if any such adverse effect exists, evaluate the
potential or probability of occurrence of these effects
Slide 30
Article 5.1-5.2
risk assessment
Panel - Hormones
• Existence of a risk assessment?
– The EC had invoked several scientific reports that the
experts advising the Panel considered to be risk
assessments
– For five of the hormones, the Panel assumed that the EC
had demonstrated the existence of a risk assessment.
WTO
Slide 31
Article 5.1-5.2
risk assessment
Panel - Hormones
• However, the Panel found that the EC measure
was not based on the scientific evidence submitted.
WTO
Slide 32
Article 5.1-5.2
risk assessment
Panel - Hormones
“In our view, the scientific conclusion reflected in the EC
measures in dispute, i.e., that the use of the hormones in
dispute for growth promotion purposes, even in accordance
with good practice, is not safe, does not conform to any of
the scientific conclusions reached in the evidence referred
to by the European Communities. ...”
EC-Hormones, Panel Report, para. 8.137
WTO
Slide 33
Article 5.1-5.2
risk assessment
Panel - Hormones
“ The EC import ban of meat and meat products from animals
treated with any of the five hormones at issue for growth
promotion purposes, allegedly necessary to protect human
health, in so far as it also applies to meat and meat
products from animals treated with any of these hormones
in accordance with good practice, is, therefore, not based
on the scientific evidence submitted to the Panel.”
EC-Hormones, Panel Report, para. 8.137
WTO
Slide 34
Article 5.1-5.2
risk assessment
Panel - Hormones
Article 2.2
“lack of an objective
relationship”
scientific conclusions reached in
each of the studies
measure
compared to
the scientific evidence
before the Panel
WTO
 Article 5.1
the scientific conclusion reflected
in the measure
Slide 35
Article 5.1-5.2
risk assessment
AB - Hormones
• Upheld finding on 5.1.
– lack of a “rational relationship” between measure and
science
• other points:
– Article 5.2 not a closed list (risk related to control and
other non-scientific factors could be considered)
– Article 5.1 is not prescriptive on who does the risk
assessment.
WTO
Slide 36
Article 5.1-5.3
risk assessment
Article 2
Hormones
Salmon
food safety
animal health
(5.1-5.2)
(5.1-5.3)
WTO
Varietals
Slide 37
Article 5.1-5.2
risk assessment
Panel - Salmon
The definition of a risk assessment for pest or disease-borne risk
• "the evaluation of the likelihood of entry, establishment or
spread of a pest or disease within the territory of an
importing Member according to the sanitary or phytosanitary
measure which might be applied, and of the associated
potential biological and economic consequences".
–
WTO
SPS Agreement, Annex A, Paragraph 4, first sentence
Slide 38
Risk Assessment
(Annex A - Definition)
• The difference between the two definitions:
– Food borne: evaluation of the potential for adverse effects on
human or animal health
– Disease or pest risk: an evaluation of the likelihood of entry,
establishment or spread of a disease, and the associated potential
biological and economic consequences
WTO
Slide 39
Article 5.1-5.2
risk assessment
Panel - Salmon
WTO
1
“identify the disease(s) whose entry, establishment or spread
within its territory it wants to prevent as well as the associated
potential biological and economic consequences
2
“evaluate the likelihood of entry, establishment or spread of
these diseases, as well as the associated potential biological and
economic consequences; and,
3
“evaluate the likelihood of entry, establishment and spread of
these diseases according to the SPS measure which might be
applied
Slide 40
Article 5.1-5.2
risk assessment
Panel - Salmon
1
“identify”
• Consistent
= no violation of Article 5.1
– 24 diseases identified ...
2
3
“evaluate the
likelihood of entry
“… according to the
SPS measure …”
• No finding - assumed consistent
– some elements of both possibility and probability
– nevertheless surprised that Australia had not used a
previous risk assessment
• No finding - assumed consistent
– evaluates to some extent a series of risk reduction
factors (five quarantine options)
WTO
Slide 41
Article 5.1-5.2
risk assessment
AB - Salmon
1
“identify”
2
“evaluate the
likelihood of entry
3
“… according to the
SPS measure …”
• Consistent (agreed with Panel)
 Article 5.1
 Article 2.2
• Requirement not met (disagreed)
– “some” evaluation of likelihood was not enough
– referred to experts’ opinions that had agreed that an
evaluation and expression of probability or
likelihood, either quantitative or qualitative was
crucial to a risk assessment.
• Requirement not met (disagreed)
– “some” evaluation was not enough
WTO
Slide 42
summary so far
Risk Assessment
(Article 5.1-5.2)
Risk Assessment
(Article 5.1-5.2)
Scientific evidence
(Article 2.2)
Hormones
Salmon
Varietals
• Rational relationship between the measure and the science
• The approach to a risk assessment:
– food-borne: identify / evaluate potential
– disease- or pest borne: identify / evaluate likelihood /
according to measure applied
WTO
Slide 43
Article 5 - Risk Assessment
“Assessment of Risk and Determination of the Appropriate Level of
Sanitary or Phytosanitary Protection”
Article 2.2
Article 5
Article 5.1-5.3
risk assessment
Article 5.5
consistency
Article 5.7
insufficient
scientific ...
WTO
Slide 44
“consistency” (Article 5.5)
“With the objective of achieving consistency in the application of the
concept of appropriate level of sanitary or phytosanitary protection against
risks to human life or health, or to animal and plant life or health, each
Member shall avoid arbitrary or unjustifiable distinctions in the levels it
considers to be appropriate in different situations, if such distinctions result
in discrimination or a disguised restriction on international trade. Members
shall cooperate in the Committee, in accordance with paragraphs 1, 2 and 3
of Article 12, to develop guidelines to further the practical implementation
of this provision. In developing the guidelines, the Committee shall take
into account all relevant factors, including the exceptional character of
human health risks to which people voluntarily expose themselves”
WTO
Slide 45
“consistency” (Article 5.5)
“With the objective of achieving consistency in the
application of the concept of appropriate level of
sanitary or phytosanitary protection against risks to
human life or health, or to animal and plant life or
health, each Member shall avoid arbitrary or
unjustifiable distinctions in the levels it considers to
be appropriate in different situations, if such
distinctions result in discrimination or a disguised
restriction on international trade.
WTO
Slide 46
“consistency” (Article 5.5)
Not an issue
Hormones
Salmon
Three pronged test
(Varietals)
Q1
Q2
WTO
Q3
Slide 47
“consistency” (Article 5.5)
Q2
Q1
Are the situations
comparable?
Are there different
levels of protection?
Are the differences
in levels of
protection “arbitrary
or unjustifiable”?
Do the differences result
in “discrimination or a
disguised restriction on
international trade?”
Panel
WTO
Q3
AB
Slide 48
Article 5.5 - “consistency”
Panel - Hormones
SITUATIONS
1
Different treatment for: administered natural hormones for
growth promotion compared to (i) those occurring endogenously
in meat and other foods; ….
2
Different treatment for: synthetic hormones for growth
promotion compared to natural hormones occurring
endogenously in meat and other foods
3
Different treatment for: hormones used for growth-promotions
purposes and carbadox (anti-microbial growth-promoter used as
a feed additive in swine production)
WTO
Slide 49
1
SITUATION
Different treatment for: administered natural hormones
for growth promotion compared to those occurring
endogenously in meat and other foods
Q2
Q1
Q3
• Comparable? (Yes)
– Yes. Same potential adverse health effect (carcinogenicity)
• Different levels of protection? (Yes)
– Yes. “No residue” allowed level as opposed to unlimited
residue level.
WTO
Slide 50
1
SITUATION
Different treatment for: administered natural hormones
for growth promotion compared to (i) those occurring
endogenously in meat and other foods;
Q1
•
Q2
Q3
Are the differences in levels of protection “arbitrary or unjustifiable”? (Yes.)
– The potential for adverse effects are the same (either for administered or endogenous).
– The total residue level of natural hormones in meat from treated animals falls well
within the physiological range of levels found in meat from untreated animals, which
levels vary according to sex and age of the animal
– The residue level of natural hormones in many natural products (such as eggs and soya
oil) is much higher than the level of residues of these hormones administered for growth
promotion - as well as the total residue level of these hormones - in treated meat
– Significant difference in levels of protection
AB: Reversed
WTO
Slide 51
1
SITUATION
Different treatment for: administered natural hormones
for growth promotion compared to (i) those occurring
endogenously in meat and other foods;
Q1
Q2
Q3
AB: Reversed
•
“We do not share the Panel's conclusions that the above differences in levels of
protection in respect of added hormones in treated meat and in respect of naturallyoccurring hormones in food, are merely arbitrary and unjustifiable. To the
contrary, we consider there is a fundamental distinction between added hormones
(natural or synthetic) and naturally-occurring hormones in meat and other foods.”
–
WTO
Hormones, AB Report, para. 221.
Slide 52
Article 5.5 - “consistency”
Panel - Hormones
SITUATIONS
1
Different treatment for: administered natural hormones for
growth promotion compared to (i) those occurring endogenously
in meat and other foods; (ii) those used for therapeutic or
zootechnical purposes
2
Different treatment for: synthetic hormones for growth
promotion compared to natural hormones occurring
endogenously in meat and other foods
3
Different treatment for: hormones used for growth-promotions
purposes and carbadox (anti-microbial growth-promoter used as
a feed additive in swine production)
WTO
Slide 53
2
Q1
•
Different treatment for: synthetic hormones for growth
promotion compared to natural hormones occurring
endogenously in meat and other foods
Q2
Q3
Are the differences in levels of protection “arbitrary or unjustifiable”? (Yes.)
– Panel found that there was no evidence that synthetic hormones were inherently more
dangerous than natural hormones, or that they were unsafe.
– No justification for a significant difference in levels of protection.
AB: Reversed
WTO
Slide 54
Article 5.5 - “consistency”
Panel - Hormones
SITUATIONS
1
Different treatment for: administered natural hormones for
growth promotion compared to (i) those occurring endogenously
in meat and other foods; (ii) those used for therapeutic or
zootechnical purposes
2
Different treatment for: synthetic hormones for growth
promotion compared to natural hormones occurring
endogenously in meat and other foods
3
Different treatment for: hormones used for growth-promotion
purposes and carbadox (anti-microbial growth-promoter used as
a feed additive in swine production)
WTO
Slide 55
3
Q1
•
Different treatment for: hormones used for growthpromotions purposes and carbadox (anti-microbial
growth-promoter used as a feed additive in swine
production)
Q2
Q3
Do the differences result in “discrimination or a disguised
restriction on international trade?” (Yes.)
–
–
–
–
–
significant difference in levels of protection
no plausible justification for this difference
leads to an import ban
+ objectives other than health (reducing beef surplus)
+ the ban on administered hormones favoured consumption of
domestic meat over US meat
– EU pork meat sector is without surpluses - competitiveness a higher
priority
AB: Reversed
WTO
Slide 56
3
Different treatment for: hormones used for growthpromotions purposes and carbadox (anti-microbial
growth-promoter used as a feed additive in swine
production)
Q1
Q2
Q3
AB: Reversed
•
“We are unable to share the inference that the Panel apparently draws that the
import ban on treated meat and the Community-wide prohibition of the use of the
hormones here in dispute for growth promotion purposes in the beef sector were
not really designed to protect its population from the risk of cancer, but rather to
keep out US and Canadian hormone-treated beef and thereby to protect the
domestic beef producers in the European Communities.”
–
WTO
Hormones, AB Report, para. 245.
Slide 57
“consistency” (Article 5.5)
- summary Q1
Q2
Q3
1
2
Violation
of 5:5
3
AB: Reversed
WTO
Slide 58
3&4
SITUATION
Canadian adult, wild ocean-caught salmon for human
consumption is restricted while, on the other hand,
whole frozen herring for use as bait and live ornamental
finfish are allowed access.
Q1
Q2
Q3
• Comparable? (Yes)
– In both situations there is at least one common disease of
concern
– The consequences associated with disease can be presumed to
be at least similar (pest- or disease-borne risk)
• Different levels of protection? (Yes)
– Salmon is effectively prohibited. Other aquatic animals
allowed in (without control for bait, and with control for
ornamental finfish)
AB: Upheld
WTO
Slide 59
3&4
SITUATION
Canadian adult, wild ocean-caught salmon for human
consumption is restricted while, on the other hand,
whole frozen herring for use as bait and live ornamental
finfish are allowed access.
Q1
Q2
Q3
• Are the differences in levels of protection “arbitrary or unjustifiable”?
(Yes.)
– Panel argued that since the level of protection for salmon is higher, one would
expect a higher risk for salmon than for the other fish. Yet the evidence was to
the contrary.
– Canada had raised a presumption that bait / ornamental fish posed a higher
risk which Australia had not rebutted.
AB: Upheld
WTO
Slide 60
3&4
SITUATION
Canadian adult, wild ocean-caught salmon for human
consumption is restricted while, on the other hand,
whole frozen herring for use as bait and live ornamental
finfish are allowed access.
Q1
•
•
•
•
•
•
WTO
1st warning signal
2nd warning signal
3rd warning signal
1st additional factor
2nd additional factor
3rd additional factor
Q2
Q3
 Article 5:5
Slide 61
3&4
SITUATION
Q3
•
•
Arbitrary character in the differences in the levels of protection (bait/ornamental
finfish can be presumed to represent a higher risk)
Substantial differences in levels of protection.
– AB: emphasis on the degree of difference
•
Violation of Article 5.1 and 2.2
– AB: non-existence of a risk assessment a strong indication that the measure was not
really concerned with the protection of health
•
Same measure to products which can be presumed to represent the same risk
– AB reversed: Same as first warning signal.
•
•
Lack of sufficient (scientific) explanation for the change in conclusions between
the 1995 Draft Report and the 1996 Final Report - inspired by domestic pressures
to protect Australian salmon industry
Internal movement restrictions not as severe
– AB: Panel’s doubts do not carry much wait but can be taken into consideration
WTO
Slide 62
3&4
SITUATION
Canadian adult, wild ocean-caught salmon for human
consumption is restricted while, on the other hand,
whole frozen herring for use as bait and live ornamental
finfish are allowed access.
Q1
•
•
•
•
•
•
1st warning signal
2nd warning signal
3rd warning signal
1st additional factor
2nd additional factor
3rd additional factor
Q2
Q3
 Article 5:5
AB: Upheld
WTO
Slide 63
“consistency” (Article 5.5)
- summary Q1
3&4
WTO
Q2
Q3
Violation
of 5:5
Slide 64
“consistency” (Article 5.5)
key points
Both the Panel and the AB used the same three
pronged test to show a violation of Article 5.5.
Separate requirement of discrimination
Q3
Do the differences result
in “discrimination or a
disguised restriction on
international trade?”
Comparable situations, a broad concept
WTO
Slide 65
Harmonization (Article 3)
Article 3.1
“To harmonize sanitary and phytosanitary measures on as wide a
basis as possible, Members shall base their sanitary or phytosanitary
measures on international standards, guidelines or
recommendations, where they exist, except as otherwise provided
for in this Agreement, and in particular in paragraph 3”
WTO
Slide 66
Harmonization (Article 3)
"the relevant international organizations"
WTO
food safety
animal health
plant health
CODEX
OIE
IPPC
Slide 67
Harmonization (Article 3)
Article 3.3
“Members may introduce or maintain sanitary or phytosanitary measures
which result in a higher level of sanitary or phytosanitary protection than
would be achieved by measures based on the relevant international standards,
guidelines or recommendations, if there is a scientific justification, or as a
consequence of the level of sanitary or phytosanitary protection a Member
determines to be appropriate in accordance with the relevant provisions of
paragraphs 1 through 8 of Article 5.3 Notwithstanding the above, all measures
which result in a level of sanitary or phytosanitary protection different from
that which would be achieved by measures based on international standards,
guidelines or recommendations shall not be inconsistent with any other
provision of this Agreement.”
WTO
Slide 68
Harmonization (Article 3)
Article 3.3
… higher level … if ...
there is a scientific justification
or
as a consequence of the level
of sanitary or phytosanitary
protection a Member
determines to be appropriate
...
Notwithstanding
shall not be inconsistent with any other provision of this Agreement
WTO
Slide 69
Harmonization (Article 3)
Article 3.2
“Sanitary or phytosanitary measures which conform to
international standards, guidelines or recommendations shall be
deemed to be necessary to protect human, animal or plant life or
health, and presumed to be consistent with the relevant
provisions of this Agreement and of GATT 1994.
WTO
Slide 70
Harmonization (Article 3)
Article 3.1
shall base ...
Hormones
Article 3.2
conform to ...
consistent
Salmon
started with Article 5
and then found that
there was no need to
go further
WTO
Article 3.3
higher level
Varietals
no claims
Slide 71
Harmonization (Article 3)
Article 3.1
shall base ... measures on
international standards
Article 3.2
Article 3.3
conform to ...
consistent
higher level
• Does an international standard exist? Yes, for five.
– Three natural hormones (unnecessary to establish ADI or
MRL)
– Two synthetic: Codex Standards apply.
WTO
Slide 72
Harmonization (Article 3)
Article 3.1
shall base ... measures on
international standards
Article 3.2
conform to ...
consistent
Article 3.3
higher level
• What is the meaning of “based on”?
– The Panel equated “based on” with “conform to”. For a
measure to be based on and international standard, it needed
to be reflect the same level of sanitary protection as the
standard.
AB: Disagreed
WTO
Slide 73
Harmonization (Article 3)
AB - Hormones
“Under Article 3.1 of the SPS Agreement, a Member may
choose to establish an SPS measure that is based on the
existing relevant international standard, guideline or
recommendation. Such a measure may adopt some, not
necessarily all, of the elements of the international
standard. The Member imposing this measure does not
benefit from the presumption of consistency set up in
Article 3.2”
EC-Hormones, AB Report, para. 171
WTO
Slide 74
Harmonization (Article 3)
Article 3.1
shall base ... measures on
international standards
Article 3.2
conform to ...
consistent
Article 3.3
higher level
• Is the EC measure based on the international standard?
(No).
– The level of protection is significantly different (higher) than
for Codex standards for both the natural and the synthetic
hormones.
WTO
Slide 75
Harmonization (Article 3)
Article 3.1
shall base ... measures on
international standards
Article 3.2
conform to ...
consistent
Article 3.3
higher level
• When can Article 3.3 be invoked?
– Two conditions (either or)
– Regardless of the two conditions, the measure nevertheless
has to comply with the other conditions of the SPS
Agreement.
• Is there a violation?
– Measure can only be justified under Article 3.3 if the measure
meets, inter alia, the requirements imposed by Article 5. 
•
WTO
Examine Article 5 first.
Slide 76
Harmonization (Article 3)
Article 3.1
shall base ... measures on
international standards
Article 3.2
conform to ...
consistent
Article 3.3
higher level
AB: Agreed with Panel’s conclusion
•
Agreed with the Panel’s finding that EC is required by Article 3.3 to
comply with the requirements of Article 5.1.
•
Stressed that the right of a Member to determine its own appropriate
level of protection is an important right
•
Stated that the right of a Member to establish its own level of
protection under Article 3.3 is an autonomous right and not an
“exception” from a “general obligation” under Article 3.1.
WTO
Slide 77
Some key issues
• Rational or objective relationship between the
measure and the science
• Approach by Panel and AB to risk assessment
(food-borne and pest- or disease-borne risk)
• The use of precaution in situations where
there is insufficient scientific evidence (5.7)
• Approach by Panel and AB when showing for
discrimination (5:5)
WTO
Slide 78
Internet: “www.wto.org”
“Hormones” (two)
EC Measures Concerning Meat and Meat Products (Hormones)
WT/DS26 and 48/ ...
“Salmon”
Australia - Measures Affecting Importation of Salmon
WT/DS18/ ...
“Varietals”
Japan - Measures Affecting Agricultural Products
WT/DS76/ ...
WTO
Slide 79
The SPS Agreement
and its provisions relating to
scientific evidence
WTO
Slide 80