The SPS Agreement and its provisions relating to scientific evidence

1
The SPS Agreementand its provisions relating
toscientific evidence
2
Three SPS Disputes
HormonesEC - Measures Concerning Meat and
Meat Products (Hormones)
SalmonAustralia - Measures Affecting
Importation of Salmon
VarietalsJapan - Measures Affecting
Agricultural Products
3
science
4
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
5
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.
6
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.
7
Article 22(Basic Rights and Obligations)
Hormones
Salmon
Varietals
8
Article 22(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.

9
Article 22(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

10
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
11
Article 22(Basic Rights and Obligations)
Panel - Varietals
lack of an objective relationship
measure

• the scientific evidence submitted before the
  Panel

12
Article 22(Basic Rights and Obligations)
AB - Varietals

• Upheld.
• (with respect to apples, cherries, nectarines and
  walnuts)
• Japan -Varietals, AB, para. 85.

13
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
14
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
15
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.
16
Article 57qualified exemption
Panel - Varietals

• Japan specifically invoked 57. 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.

17
Article 57qualified exemption
Panel - Varietals
Allowed to provisionally adopt a measure if
the measure is imposed in respect of a situation
where relevant scientific information is
insufficient
1
and
the measure is adopted on the basis of available
pertinent information
2
18
Article 57qualified exemption
Panel - Varietals
additional obligations
seek to obtain the additional information
necessary for a more objective assessment of
risk and,
3
and
review the phytosanitary measure accordingly
within a reasonable period of time.
4
19
Article 57qualified 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

20
Article 57qualified 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

21
Article 57qualified 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.

22
Article 57qualified 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.

23
Article 5 - Risk AssessmentAssessment of Risk
and Determination of the Appropriate Level of
Sanitary or Phytosanitary Protection
Article 2.2
Article 5.1-5.3risk assessment
Article 5.5consistency
24
Risk Assessment(Article 5.1 - 5.3)
Article 5.1 Members shall ensure that their
sanitary or phytosanitary measures are based on
an assessment, as 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.
25
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
26
Risk Assessment(Article 5.1 - 5.3)
Article 5.3 In assessing the risk to animal or
plant life or health and determining the measure
to be applied for achieving the appropriate level
of sanitary or phytosanitary protection from such
risk, Members shall take into account as relevant
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.
27
Risk Assessment(Article 5.1 - 5.3)

• 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

Article 5.1
Article 5.2
Article 5.3
28
Article 5.1-5.3risk assessment
Hormones
Salmon
Varietals
29
Article 5.1-5.2risk 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".
• SPS Agreement, Annex A, Paragraph 4, second
  sentence

30
Article 5.1-5.2risk assessment
Panel - Hormones
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
1
if any such adverse effect exists, evaluate the
potential or probability of occurrence of these
effects
2
31
Article 5.1-5.2risk 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.

32
Article 5.1-5.2risk assessment
Panel - Hormones

• However, the Panel found that the EC measure was
  not based on the scientific evidence submitted.

33
Article 5.1-5.2risk 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

34
Article 5.1-5.2risk 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

35
Article 5.1-5.2risk assessment
Panel - Hormones
? Article 5.1
compared to
36
Article 5.1-5.2risk 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.

37
Article 5.1-5.3risk assessment
Hormones
Salmon
Varietals
38
Article 5.1-5.2risk 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".
• SPS Agreement, Annex A, Paragraph 4, first
  sentence

39
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

40
Article 5.1-5.2risk assessment
Panel - Salmon
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
1
evaluate the likelihood of entry, establishment
or spread of these diseases, as well as the
associated potential biological and economic
consequences and,
2
evaluate the likelihood of entry, establishment
and spread of these diseases according to the SPS
measure which might be applied
3
41
Article 5.1-5.2risk assessment
Panel - Salmon
no violation of Article 5.1

• Consistent
• 24 diseases identified ...
• No finding - assumed consistent
• some elements of both possibility and probability
• nevertheless surprised that Australia had not
  used a previous risk assessment
• No finding - assumed consistent
• evaluates to some extent a series of risk
  reduction factors (five quarantine options)

identify
1
evaluate the likelihood of entry
2
according to the SPS measure
3
42
Article 5.1-5.2risk assessment
AB - Salmon
? Article 5.1 ? Article 2.2
identify

• Consistent (agreed with Panel)
• Requirement not met (disagreed)
• some evaluation of likelihood was not enough
• referred to experts opinions that had agreed
  that an evaluation and expression of probability
  or likelihood, either quantitative or qualitative
  was crucial to a risk assessment.
• Requirement not met (disagreed)
• some evaluation was not enough

1
evaluate the likelihood of entry
2
according to the SPS measure
3
43
summary so far
Scientific evidence (Article 2.2)
Risk Assessment(Article 5.1-5.2)
Risk Assessment(Article 5.1-5.2)
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

44
Article 5 - Risk AssessmentAssessment of Risk
and Determination of the Appropriate Level of
Sanitary or Phytosanitary Protection
Article 2.2
Article 5.1-5.3risk assessment
Article 5.5consistency
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.
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
46
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.
47
consistency (Article 5.5)
Not an issue
Hormones
Salmon
(Varietals)

• Three pronged test

Q1
Q2
Q3
48
consistency (Article 5.5)
Q1
Are the situations comparable?Are there
different levels of protection?
49
Article 5.5 - consistency
Panel - Hormones
SITUATIONS
50
SITUATION
1
Different treatment for administered natural
hormones for growth promotion compared to those
occurring endogenously in meat and other foods
Q1
Q2
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.

51
SITUATION
1
Different treatment for administered natural
hormones for growth promotion compared to (i)
those occurring endogenously in meat and other
foods
Q1
Q3
Q2

• 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

52
SITUATION
1
Different treatment for administered natural
hormones for growth promotion compared to (i)
those occurring endogenously in meat and other
foods
Q1
Q3
Q2

• 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 naturally-occurring 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.
• Hormones, AB Report, para. 221.

AB Reversed
53
Article 5.5 - consistency
Panel - Hormones
SITUATIONS
54
Q2
Q1
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.

55
Article 5.5 - consistency
Panel - Hormones
SITUATIONS
56
3
Different treatment for hormones used for
growth-promotions purposes and carbadox
(anti-microbial growth-promoter used as a feed
additive in swine production)
Q3
Q1
Q2

• 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

57
3
Different treatment for hormones used for
growth-promotions purposes and carbadox
(anti-microbial growth-promoter used as a feed
additive in swine production)
Q3
Q1
Q2

• 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.
• Hormones, AB Report, para. 245.

AB Reversed
58
consistency (Article 5.5)- summary -
Q1
Q3
Q2
1
2
3
59
SITUATION
34
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
60
SITUATION
34
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
61
SITUATION
34
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

• 1st warning signal
• 2nd warning signal
• 3rd warning signal
• 1st additional factor
• 2nd additional factor
• 3rd additional factor

? Article 55
62
SITUATION
34
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 Panels doubts do not carry much wait but can
  be taken into consideration

63
SITUATION
34
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

• 1st warning signal
• 2nd warning signal
• 3rd warning signal
• 1st additional factor
• 2nd additional factor
• 3rd additional factor

? Article 55
AB Upheld
64
consistency (Article 5.5)- summary -
Q1
Q3
Q2
34
Violation of 55
65
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
Comparable situations, a broad concept
66
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
67
Harmonization (Article 3)
"the relevant international organizations"
68
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.
69
Harmonization (Article 3)
Article 3.3
70
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.
71
Harmonization (Article 3)
72
Harmonization (Article 3)
Article 3.1
Article 3.2
Article 3.3
shall base ... measures on international standards
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.

73
Harmonization (Article 3)
Article 3.1
Article 3.2
Article 3.3
shall base ... measures on international standards
conform to ... consistent
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
74
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

75
Harmonization (Article 3)
Article 3.1
Article 3.2
Article 3.3
shall base ... measures on international standards
conform to ... consistent
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.

76
Harmonization (Article 3)
Article 3.1
Article 3.2
Article 3.3
shall base ... measures on international standards
conform to ... consistent
higher level

• When can Article 3.3 be invoked?
• Two conditions (either or)
• Regardless of the two conditions, the measure
  nevertheless has to comply with the other
  conditions of the SPS Agreement.
• Is there a violation?
• Measure can only be justified under Article 3.3
  if the measure meets, inter alia, the
  requirements imposed by Article 5. ?
• Examine Article 5 first.

77
Harmonization (Article 3)
Article 3.1
Article 3.2
Article 3.3
shall base ... measures on international standards
conform to ... consistent
higher level

• Agreed with the Panels 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.

AB Agreed with Panels conclusion
78
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 (55)

79
Internet www.wto.org
Hormones (two)EC Measures Concerning Meat
and Meat Products (Hormones)WT/DS26 and 48/ ...
SalmonAustralia - Measures Affecting
Importation of SalmonWT/DS18/ ...
VarietalsJapan - Measures Affecting
Agricultural ProductsWT/DS76/ ...
80
The SPS Agreementand its provisions relating
toscientific evidence