the sps agreement and its provisions relating to scientific evidence

WTO Slide 1

The SPS Agreementand its provisions relating to

scientific evidence

WTO Slide 2

Three “SPS Disputes”

“Hormones”EC - Measures Concerning Meat and Meat Products (Hormones)

“Salmon”Australia - Measures Affecting Importation of Salmon

“Varietals”Japan - Measures Affecting Agricultural Products

WTO Slide 3

“science”Basic Rights and

Obligations (Article 2)

Int’l org.(Article 12:3)

Harmonization (Article 3)

Risk Assessment(Article 5)

Expert advice(Article 11:2)

WTO Slide 4

Article 2.1

“Members have the right to take sanitary and phytosanitary measures necessary for the protection of human, animal or

plant life or health, provided that such measures are not inconsistent with the provisions of this Agreement”

Basic Rights and Obligations(Article 2)

WTO Slide 5

Article 2.2

“Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect

human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific

evidence, except as provided for in paragraph 7 of Article 5.”

Basic Rights and Obligations(Article 2)

WTO Slide 6

Article 2.2

shall ensure:

Basic Rights and Obligations

applied only to the extent necessary to protect human, animal or plant life or

health

is based on scientific principles

is not maintained without sufficient scientific evidence

except as provided for in paragraph 7 of Article 5.

WTO Slide 7

focus on risk assessment (Article 5)

Hormones Salmon Varietals

Article 2:2(Basic Rights and Obligations)

WTO Slide 8

“In our view, for a phytosanitary measure to be ‘maintained without’ sufficient scientific evidence, there needs to be a

lack 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.

Panel - Varietals


WTO Slide 9

The Panel reviewed the parties’ submissions and the advice from the scientific experts (entomology, fumigation) and concluded:

“it has not been sufficiently demonstrated that there is a rational relationship between the varietal testing requirement and the

scientific evidence submitted to the Panel”Japan -Varietals, Panel Report, para. 8.42

Panel - Varietals


WTO Slide 10

Article 2.2

shall ensure:



health



except as provided for in paragraph 7 of Article 5

WTO Slide 11


Panel - Varietals

“lack of an objective relationship”

“measure”

“the scientific evidence submitted before the Panel”

Article 2.2 (?)

WTO Slide 12

AB - Varietals

Upheld.(with respect to apples, cherries, nectarines and walnuts)

Japan -Varietals, AB, para. 85.


WTO Slide 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

WTO Slide 14

Article 2.2

shall ensure:



health



except as provided for in paragraph 7 of Article 5

WTO Slide 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.”

WTO Slide 16

Article 5:7“qualified exemption”

• 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.

Panel - Varietals

WTO Slide 17


Panel - Varietals

the measure is imposed in respect of a situation where “relevant” scientific information is insufficient;

the measure is adopted “on the basis of available pertinent information”

Allowed to provisionally adopt a measure if:

1

2

and

WTO Slide 18


Panel - Varietals

“seek to obtain the additional information necessary for a more objective assessment of risk”; and,

“review the … phytosanitary measure accordingly within a reasonable period of time”.

+ additional obligations:

3

4

and

WTO Slide 19


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

…….

…….

…….

…….


WTO Slide 20

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 21


• 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.

Panel - Hormones

WTO Slide 22


• 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.

AB - Hormones

WTO Slide 23

Article 5 - Risk Assessment“Assessment of Risk and Determination of the Appropriate Level of

Sanitary or Phytosanitary Protection”

Article 5.1-5.3risk assessment

Article 5.5consistency

Article 5

Article 5.7insufficient scientific ...

Article 2.2

WTO Slide 24

Risk Assessment(Article 5.1 - 5.3)

Article 5.1

“Members shall ensure that their sanitary or phytosanitary measures are based on an

assessment, as 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 25


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 26


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 27


Article 5.1

Article 5.2

Article 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

WTO Slide 28



Focus on 2.2“scientific evidence”

food safety (5.1-5.2)

animal health(5.1-5.3)

WTO Slide 29


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

Panel - Hormones

WTO Slide 30


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

“if any such adverse effect exists, evaluate the potential or probability of occurrence of these effects

1

2

WTO Slide 31


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 32


Panel - Hormones

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

WTO Slide 33


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 34


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 35

Panel - Hormones


compared to

scientific conclusions reached in each of the studies

the scientific conclusion reflected in the measure

Article 2.2“lack of an objective

relationship”

measure

the scientific evidence before the Panel

Article 5.1

WTO Slide 36

AB - Hormones

• Upheld finding on 5.1.– lack of a “rational relationship” between measure and

science

• other points:– Article 5.2 not a closed 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 37



Article 2

food safety (5.1-5.2)

animal health(5.1-5.3)

WTO Slide 38


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

Panel - Salmon

WTO Slide 39

• 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

Risk Assessment(Annex A - Definition)

WTO Slide 40


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

“evaluate the likelihood of entry, establishment or spread of these diseases, as well as the associated potential biological and economic consequences; and,

“evaluate the likelihood of entry, establishment and spread of these diseases according to the SPS measure which might be applied

2

1

3

WTO Slide 41

• Consistent– 24 diseases identified ...

• No finding - assumed consistent– some elements of both possibility and probability– nevertheless surprised that Australia had not used a

previous risk assessment

• No finding - assumed consistent– evaluates to some extent a series of risk reduction

factors (five quarantine options)


Panel - Salmon

“identify”

“evaluate the likelihood of entry

“… according to the SPS measure …”

= no violation of Article 5.11

2

3

WTO Slide 42


“identify”

“evaluate the likelihood of entry

“… according to the SPS measure …”

• Consistent (agreed with Panel)

• Requirement not met (disagreed)– “some” evaluation of likelihood was not enough– referred to experts’ opinions that had agreed that an

evaluation and expression of probability or likelihood, either quantitative or qualitative was crucial to a risk assessment.

• Requirement not met (disagreed)– “some” evaluation was not enough


AB - Salmon

1

2

3

WTO Slide 43


summary so far

Scientific evidence (Article 2.2)

Risk Assessment(Article 5.1-5.2)

Risk Assessment(Article 5.1-5.2)

• 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 44

Article 5 - Risk Assessment“Assessment of Risk and Determination of the Appropriate Level of

Sanitary or Phytosanitary Protection”


Article 5.5consistency

Article 5

Article 5.7insufficient scientific ...

Article 2.2

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.

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 46

“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 47

Hormones Salmon (Varietals)Not an issue

Three pronged test


Q1

Q2

Q3

WTO Slide 48

Are the situations comparable?

Are there different levels of protection?


Q1

Do the differences result in “discrimination or a disguised restriction on

international trade?”

Q3

Panel AB

Are the differences in levels of

protection “arbitrary or unjustifiable”?

Q2

WTO Slide 49

Article 5.5 - “consistency”Panel - Hormones

SITUATIONS

1Different treatment for: administered natural hormones for growth promotion compared to (i) those occurring endogenously in meat and other foods; ….

2Different treatment for: synthetic hormones for growth promotion compared to natural hormones occurring endogenously in meat and other foods

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

WTO Slide 50

1 SITUATION

• 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.

Different treatment for: administered natural hormones for growth promotion compared to those occurring endogenously in meat and other foods

Q1 Q2 Q3

WTO Slide 51

Q1 Q3Q2

1 SITUATION

• 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

Different treatment for: administered natural hormones for growth promotion compared to (i) those occurring endogenously in meat and other foods;

WTO Slide 52

Q1 Q3Q2

1

Different treatment for: administered natural hormones for growth promotion compared to (i) those occurring endogenously in meat and other foods;

SITUATION

• “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

WTO Slide 53


SITUATIONS

1Different 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


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

WTO Slide 54


Q2

• 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

Q1 Q3

WTO Slide 55


SITUATIONS

1Different 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


3Different treatment for: hormones used for growth-promotion purposes and carbadox (anti-microbial growth-promoter used as a feed additive in swine production)

WTO Slide 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

• 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

Q1 Q2

AB: Reversed

WTO Slide 57

• “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

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

Q3Q1 Q2

WTO Slide 58

“consistency” (Article 5.5)- summary -

Q1 Q3Q2

1

2

3

Violation of 5:5

AB: Reversed

WTO Slide 59

SITUATION

• 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)

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

AB: Upheld

3&4

WTO Slide 60

Q1 Q3Q2

SITUATION

• 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

3&4

WTO Slide 61

Q1 Q3Q2

SITUATION

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


Article 5:5

3&4

WTO Slide 62

Q3

SITUATION

• 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

3&4

WTO Slide 63

Q1 Q3Q2

SITUATION

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


3&4

Article 5:5

AB: Upheld

WTO Slide 64

“consistency” (Article 5.5)- summary -

Q1 Q3Q2

Violation of 5:5

3&4

WTO Slide 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.

Comparable situations, a broad concept

Separate requirement of discriminationDo the differences result in “discrimination or a disguised restriction on

international trade?”

Q3

WTO Slide 66

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 67

"the relevant international organizations"

food safetyCODEX

plant healthIPPC

animal healthOIE


WTO Slide 68

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 69


Article 3.3

… higher level … if ...

there is a scientific justification

as a consequence of the level of sanitary or

phytosanitary protection a Member

determines to be appropriate ...

or

Notwithstanding

shall not be inconsistent with any other provision of this Agreement

WTO Slide 70

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 71


Article 3.1 Article 3.2 Article 3.3

shall base ... conform to ... consistent higher level


no claims

started with Article 5 and then found that there was no need to

go further

WTO Slide 72



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.

WTO Slide 73





• 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 74

“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


AB - Hormones

WTO Slide 75





• 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 76





• 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.

WTO Slide 77





• 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.

AB: Agreed with Panel’s conclusion

WTO Slide 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 (5:5)

WTO Slide 79

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 80

The SPS Agreementand its provisions relating to

scientific evidence

the sps agreement and its provisions relating to scientific evidence

Documents

sufficient scientific

scientific principlesis

panel varietalsbasic

agreementbasic rights

scientific experts entomology

plant life

panel report

extent necessary