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M y C o u r s e s e r i e s

OBJECTIVES

Present the obligations regarding risk assessment and the

determination of the appropriate level of protection contained in the

SPS Agreement, including the disciplines regarding consistency and

provisional measures. (Article 5);

Explain the subject as interpreted in WTO Dispute Settlement;

Explain the obligations related to regionalization (Article 6).

WTO E-LEARNING COPYRIGHT © 12

Detailed Presentation of Risk Assessment and Level of Protection related to SPS

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I. INTRODUCTION

A WTO Member has the right to adopt SPS measures to achieve its self-determined level of health protection.

That is, the WTO Member determines the level of protection it aims to achieve, and adopts the measures which

allow it to achieve this level.

Remember that the right to adopt SPS measures is accompanied by basic obligations, contained in Article 2

and further elaborated in other provisions. Essentially, countries may adopt SPS measures provided these:

are applied only to the extent necessary to protect life or health;

are based on scientific principles and not maintained without sufficient scientific evidence; and

do not unjustifiably discriminate between national and foreign, or among foreign sources of supply.

As we learned before, Members have two options to show that their measures are based on science. They may

either:

base their measures on international standards; OR

base their measures on scientific risk assessment.

In this Module, it is one of our aims to discuss how Members may comply with the obligation to base SPS

measures on science by basing them on scientific risk assessment.

This differs from harmonization because the measure adopted by a Member is not based on an internationally

agreed standard, but rather on a specific assessment of risks and the appropriate level of protection the

Member believes necessary for human, animal or plant life or health.

Harmonization is a central discipline in the SPS Agreement and takes place in situations where Members base

their SPS measures on international standards, thus adopting common standards. Note that, even with

harmonization, each Member adopts its own measure to reflect its appropriate level of protection – but without

necessarily doing a risk assessment.

Harmonization is articulated into obligations and rights for WTO Members, which are recalled below.

RECALL

THE TWO MAIN REQUIREMENTS ARE THAT

Members shall base their SPS measures on international standards, guidelines or recommendations; and

Members shall participate in the development and periodic review of international standards, guidelines

and recommendations prepared by international standard-setting bodies, in particular the "three

sisters".

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THE TWO MAIN RIGHTS ARE THAT

Members' SPS measures which conform to international standards, guidelines or recommendations will

be deemed to be necessary and presumed to be consistent with the relevant provisions of the

SPS Agreement.

Members may, however, adopt SPS measures which are stricter than the relevant international

standard, if they have a scientific justification or as a consequence of the level of protection a Member

determines to be appropriate, in accordance with the relevant provisions of Article 5 of the

SPS Agreement.

Annex A.3 of the SPS Agreement defines international standards as those created by the Codex Alimentarius

Commission; the World Organization for Animal Health (OIE), and the International Plant Protection Convention

(IPPC), in their respective field of action. The SPS Committee can identify other relevant international

standard-setting organizations, but has not done so to date.

We will learn first about "risk assessment"; followed by the requirements on the choice of the "appropriate

level of protection" and the requirement of consistency. We will then analyse a Member's right to adopt

provisional measures, and finally the obligations of "regionalization" in the SPS Agreement.

Please, remember to click on the hyperlinks and check the original documents. They are very important for you

to take advantage of this experience while also getting familiarized with the WTO Documentation system. Oh,

and remember to send your questions to your tutor and to also regularly participate in our discussion forums.

We are positive that your peers have a lot to discuss and that your input will be greatly appreciated!

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II. RISK ASSESSMENT

Members do not always base their measures on internationally-agreed standards, for several reasons. First, the

three sister organizations have not elaborated international standards for every aspect of food safety, animal

and plant health. Furthermore, Members may desire to adopt SPS measures that achieve a higher or lower

level of health protection than that achieved by the relevant international standards.

In this context it is important to note that the encouragement to use international standards does not mean

that these constitute a floor or a ceiling on national standards. National measures do not violate the

SPS Agreement simply because they differ from international norms.

According to Article 3 and Article 5 of the SPS Agreement, Members are permitted to adopt SPS measures

which are more stringent than the relevant international standards or adopt SPS measures when international

standards do not exist, provided the measures, in addition to the basic obligations set forth in Article 2, are:

based on scientific risk assessment;

consistently applied; and

not more trade restrictive than necessary.

Article 5 disciplines the "assessment of risk and the determination of the appropriate level of sanitary and

phytosanitary protection". Article 5.1 provides:

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.

In order to establish if an SPS measure is based on a risk assessment, as required by Article 5.1, we should

first determine what "risk assessment" actually means.

II.A. TYPES OF RISK ASSESSMENT

IN BRIEF

There are two types of risk assessment as defined by Annex A.4 of the SPS Agreement:

Risks arising from pests or diseases: 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 SPS measures which

might be applied, and of the associated potential biological and economic consequences; or

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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It is important to determine which definition of risk assessment is applicable in a particular situation, as the

requirements are different for each type. The category of SPS measure (which depends on its aim) determines

which type of risk assessment is applicable.

II.A.1. RISK ASSESSMENT FOR RISKS ARISING FROM PESTS AND

DISEASES

The first type of risk assessment, related to the entry, establishment or spread of diseases or pests, was the

object of analysis in the Australia – Salmon case. There, Canada questioned Australia's ban on the import of

fresh, chilled or frozen salmon, allegedly imposed for animal health reasons. Because we will be discussing the

dispute Australia – Salmon quite a lot in this Module, we will give you a brief summary of the case here.

CASE STUDY: AUSTRALIA - SALMON (WT/DS18) AUSTRALIA - SALMON

Overview

Australia – Measures affecting importation of Salmon

Complaint by Canada

Respondent: Australia

Third Parties: European Communities, India, Norway, United States

The measure at issue was Australia's ban on importation of fresh, chilled or frozen salmon, allegedly to protect

the domestic salmon population from a number of diseases. Canada claimed that salmon imported for human

consumption was very unlikely to lead to the introduction of these diseases.

What did the Panel say?

The report of the Panel was circulated to Members on 12 June 1998. The Panel found that Australia's measures

were inconsistent with Articles 2.2, 2.3, 5.1, 5.5, and 5.6 of the SPS Agreement, and also nullified or impaired

benefits accruing to Canada under the SPS Agreement.

What did the Appellate Body say?

The report of the Appellate Body was circulated to Members on 20 October 1998. The Appellate Body reversed

the Panel's reasoning with respect to Articles 5.1 and 2.2 of the SPS Agreement but nevertheless found that:

Australia had acted inconsistently with Articles 5.1 and 2.2 of the SPS Agreement;

broadened the Panel's finding that Australia had acted inconsistently with Articles 5.5 and 2.3 of the

SPS Agreement;

reversed the Panel's finding that Australia had acted inconsistently with Article 5.6 of the

SPS Agreement but was unable to come to a conclusion whether or not Australia's measure was

consistent with Article 5.6 due to insufficient factual findings by the Panel.

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The Appellate Body, while analysing the case, decided that for the assessment of risks arising from pests and

diseases, a three pronged test must be met, as the risk assessment must:

identify the pests or 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 pests or diseases;

evaluate the likelihood of the entry, establishment or spread of these pests or diseases, as well as the

associated potential biological and economic consequences; and

evaluate the likelihood of entry, establishment or spread of these diseases according to the SPS

measures which might be applied.

The Appellate Body affirmed that likelihood means probability and that a mere demonstration of possibility of a

pest or disease entry, establishment or spread would not be enough to fulfil the requirement of a risk

assessment for risks arising from pests and diseases, as defined by the SPS Agreement.

Important note

The likelihood of entry may be expressed either quantitatively or qualitatively and there is no requirement

for the risk assessment to establish a certain magnitude or threshold level of the degree of risk.

II.A.2. RISK ASSESSMENT FOR FOOD-BORNE RISKS

In the dispute EC – Hormones (WT/DS26 and WT/DS48) the United States and Canada questioned the ban

imposed by the European Communities on imports of beef from hormone-treated cattle, for food safety

reasons.

The Appellate Body, in this case, applied a two-step test for the assessment of food-borne risks:

identification of the adverse effects on human (or animal, as the case may be) health arising from the

presence of additives, contaminants, etc.; AND

if such adverse effects exist, evaluation of the potential occurrence of these effects.

The Appellate Body recognized that there must be an "identifiable risk" and that, this risk need not be

quantified but can be expressed qualitatively.

Note

Moreover, the Appellate Body, in Australia – Salmon (see case explanation above) pointed to the different

language used in the first and second definitions in Annex A of the SPS Agreement. While the assessment

of food-borne risks requires an evaluation of the "potential" for adverse effects, the assessment of risks

arising from pests or diseases calls for an evaluation of the "likelihood" of their entry, establishment or

spread, which equates to probability.

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II.A.3. COMMON FEATURES BETWEEN THE TWO TYPES

Common features for both types of risk assessment, as identified in the Appellate Body reports in the two

cases examined above, are:

The risks they address should be ascertainable. Theoretical uncertainty is not the kind of risk which, under

Article 5.1, is to be assessed.

The risks covered should be specific. There is a requirement of specificity, and it is not sufficient for a risk

assessment to identify a general risk of harm, or address the overall risk related to the combination of all

diseases of concern, for example.

The risk assessment should be comprehensive and cover each of the products at issue. While the Panel on

EC-Hormones had held that a risk assessment would have to be carried out for each individual substance at

issue, the Panel on Australia – Salmon held that studies on one particular product category could be relevant

for a risk assessment in respect of another product category. Therefore, we may say that a risk assessment

undertaken for one category of product may be relevant to another category, if such products are subject to

the same or similar kind of risk.

IF YOU WANT TO KNOW MORE

INTERPRETATION OF RISK ASSESSMENT OBLIGATIONS IN WTO CASE LAW

Check the WTO Analytical Index, which summarizes the interpretation of the various Articles of the

SPS Agreement in WTO case law. The Section on Article 5.1 includes selected paragraphs of the various

Panel's and Appellate Body reports mentioned thus far in our Module, which are relevant for our study.

EXERCISES:

1. Are WTO Members permitted to adopt SPS measures which are more stringent than the relevant

international standards?

2. What are the types of risk assessment defined in the SPS Agreement? What are their common features,

according to WTO case law?

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II.B. OBLIGATIONS REGARDING RISK ASSESSMENT

Let us now examine Article 5 of the SPS Agreement in detail.

II.B.1. OBLIGATION TO BASE SPS MEASURES ON A RISK ASSESSMENT

IN DETAIL

As we mentioned above, Article 5.1 provides for the obligation to base SPS measures on an assessment of risk,

taking into account the techniques developed by relevant international organizations, which are the

Codex Alimentarius Commission, the OIE and the IPPC.

RECALL

The Appellate Body in EC – Hormones interpreted the requirement to base an SPS measure on a risk

assessment as a substantive requirement that refers to a certain objective or rational relationship between

the SPS measure and the risk assessment. Article 5.1 read together with Article 2.2 requires the results of

the risk assessment to sufficiently warrant or reasonably support the relevant SPS measure.

The requirement that SPS measures be based on a risk assessment is qualified by the sentence "as appropriate

to the circumstances", which provides for a certain degree of flexibility in meeting the requirements of

Article 5.1. Such reference relates to the way in which the risk assessment has be carried out and does not

annul or supersede the obligation to base an SPS measure on a risk assessment (Panel report in

Australia - Salmon, WT/DS 18).

Important note

As stated by the Panel in the Australia – Salmon case, the manner of carrying out a risk assessment may

vary according to the source and subject of the risk, product involved, origin and destination, including

country specific situations. The appropriateness of a risk assessment should be determined having as

references the techniques of the relevant international organizations and the opinion of scientific experts.

Furthermore:

Members are not required to base a measure on a quantitative risk assessment but may instead rely on

a qualitative assessment of potential risks (EC - Hormones).

Members are not obliged to base a measure on a risk assessment that represents mainstream scientific

opinion, they are allowed to use diverging scientific opinions from respected, qualified sources

(Appellate Body report in EC – Hormones).

Members are not required, under Article 5.1, to conduct their own risk assessment, and may base their

measures on a risk assessment carried out by another Member or by relevant international

organizations (Appellate Body report in EC – Hormones). Members are nonetheless responsible for the

appropriateness and comprehensiveness of the risk assessment on which they base a measure, which

should address the risk situation actually faced by the Member imposing the measure.

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Members have an obligation to base a measure on a risk assessment, even if the measure was enacted

before the entry into force of the SPS Agreement. (Panel report in EC - Hormones). SPS measures

should not be maintained without sufficient scientific evidence, which means that a Member should be

able to provide scientific evidence (a risk assessment) for an SPS measure which is in force and is not

based on an international standard, if so requested.

TIP

The three sisters have developed guidelines on risk analysis, which is a three-step process that includes risk

assessment, risk management and risk communication, in their respective fields of action. For your

reference:

(i) on animal health risk analysis, see the work developed by the OIE, whose principles and methods are

described in Section 1.3 of the Terrestrial Code and Section 1.4 of the Aquatic Code; and in the OIE

Handbook on Import Risk Analysis, which discusses qualitative and quantitative approaches;

(ii) on plant health risk analysis, see the work developed by the IPPC, whose relevant standards are

ISPM 2 (1995) – Guidelines for pest risk analysis, ISPM 11 (2004) – Pest risk analysis for quarantine

pests including analysis of environmental risks and living modified organisms, and ISPM 21 (2004) –

Pest Risk analysis for regulated non-quarantine pests;

(iii) on food safety risk analysis, see the work developed by the Codex, mainly the 2007 Working Principles

for Risk Analysis for Food Safety for Application by Governments (CAC/GL 62), the Principles and

Guidelines for the Conduct of Microbiological Risk Assessment (CAC/GL 30), the 2003 Principles for the

Risk Analysis of Foods derived from Modern Biotechnology (CAC/GL 44).

II.B.2. FACTORS TO BE TAKEN INTO ACCOUNT

IN DETAIL

Articles 5.2 and 5.3 provide that:

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.

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.

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These two paragraphs list certain factors Members must take into account while undertaking a risk

assessment, but do not specify a methodology to be used. 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 and other treatment.

According to the Appellate Body, Article 5.2 shows that a risk assessed 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" (Appellate Body report in EC – Hormones). The Appellate Body

further clarified that the list in Article 5.2 is not a closed one, and that risks related to detection and control of

compliance with certain requirements (such as the failure to observe good veterinary practice) may also be

taken into account as part of the risk assessment.

Article 5.3 lists various economic factors a Member has to take into account while assessing risks to animal or

plant life or health, and when choosing the SPS measure to be applied to achieve its appropriate level of

protection against such risks:

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.

Important note

Bear in mind that Members are not required to take such economic factors into consideration while

designing or applying an SPS measure aimed at the protection of human life or health.

II.B.3. RISK ASSESSMENT, RISK ANALYSIS, RISK MANAGEMENT

Article 5 refers explicitly to risk assessment. It should be noted that international standard-setting

organizations recognize risk assessment to be part of a wider process called "risk analysis".

Risk analysis is a systematic way of gathering, evaluating, recording and disseminating information leading to

recommendations for a position or action in response to an identified hazard. There are some slight variations

in the terms used by the three sister organizations.

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However, risk analysis is usually seen as a process consisting of three or four steps, depending on whether

Hazard Identification is considered as a separate step or included within Risk Assessment:

Hazard Identification, which involves specifying the adverse event which is of concern. The Codex

Alimentarius Commission includes this step within Risk Assessment;

Risk Assessment, which takes into account the probability (the expected likelihood and not just the

possibility) of the hazard occurring, the consequences of that hazard occurring, and the degree of

uncertainty involved. Note that this description of risk assessment differs somewhat from the definition

contained in the SPS Agreement, which was drafted prior to the elaboration of techniques by Codex,

IPPC and OIE;

Risk Management, which involves identifying and implementing the best option for reducing or

eliminating the likelihood of the hazard occurring; and

Risk Communication, which implies the open exchange of explanatory information and opinions that

lead to better understanding and decisions.

Risk assessment is a science-based process of determining the existence of a risk and the likelihood (or

potential in terms of risks to human life or health, in the SPS Agreement context) of it occurring. Risk

management, on the other hand, entails a policy-based choice of the level of health protection that a state

wants to secure in its territory, and the choice of an SPS measure to achieve this level of protection.

Risk management decisions are based not only on the scientific results of the risk assessment but also on

various societal value judgements such as the citizens' tolerance to risk.

IF YOU WANT TO KNOW MORE

RISK ANALYSIS

Check the website dedicated to the SPS Risk Analysis Workshop, organized by the WTO Secretariat and

held in June 2000, immediately before the 18th meeting of the SPS Committee. At the workshop's website

you will find the meeting's summary report (G/SPS/GEN/209), presentations made by various organizations

and Members, and the programme, which included:

Session I:

I.A The link between the SPS Agreement and risk analysis

I.B Fundamentals of Risk Analysis and its practical application

I.C Examples from Members/Observers

Session II:

II.A The SPS Agreement as it relates to scientific justification

II.B Examples from Members/Observers

II.C The Codex, OIE, and IPPC – their work relating to risk analysis

Session III:

III.A Examples from Members/Observers

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ILLUSTRATION

The Republic of Vanin, a WTO Member, through one of its governmental agencies, decides to address the

safety of shell eggs and egg products, and specifically the possible contamination by Salmonella Enteritidis, in

order to protect human health against food-borne risks. What should the regulatory body in Vanin keep in mind

in terms of the risk assessment obligations contained in the SPS Agreement?

Note that the objective of this illustration is not to find a final answer, but to analyse the various factors that

should be kept in mind.

Taking into consideration the SPS obligations Vanin has undertaken as a Member to the WTO, Vanin's

regulators are aware that an SPS measure may not be introduced or maintained without sufficient scientific

evidence. And before deciding which SPS measure is the most appropriate to prevent Salmonellosis as a

consequence of contaminated shell eggs and egg products, it has to review the scientific evidence on the risk,

and to determine the appropriate level of protection against that risk.

Remember that Vanin may, at any point, adopt the current international standard and base or conform its

measure to it, thus avoiding the obligation to justify its measure with a risk assessment.

Let's start by analysing the risk assessment obligations, and deal with the issue of appropriate level of

protection in the next section of our Module. Risk assessment for food-borne risks is defined by the

SPS Agreement as 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.

When discussing the meaning of the word "potential" in the context of food-borne risks, the Appellate Body

clarified that it is closer to the meaning of "possibility" then to "probability".

Furthermore, Vanin has to take into account the risk assessment techniques developed by the relevant

international organization, in this case the Codex Alimentarius Commission, which has developed the 1999

Principles and Guidelines for the Conduct of Microbiological Risk Assessment (CAC/GL 30).

Taking into consideration this specific illustration, another document that would be useful for the conduct of a

risk assessment is:

the Codex Recommended International Code of Hygienic Practice for Egg Products (CAC/RCP 15-1976),

which contains Microbiological Specifications for Pasteurized Egg Products (Section V – End Product

Specifications), with Reference Methods for the Detection of Salmonellae in Egg Products.

Furthermore, the document published jointly by the World Health Organization (WHO) and the Food and

Agriculture Organization (FAO), "Risk Assessments of Salmonella in eggs and broiler chickens" – Microbiological

Risk Assessment Series 2, could itself serve as a risk assessment on which Vanin may base its measure,

without having to conduct its own risk assessment.

In case Vanin decides to conduct its own risk assessment, this has to identify the adverse effects that the

presence of Salmonella Enteritidis in eggs causes to human health. Once the adverse effects are established, it

should evaluate the potential occurrence of these effects, in order to establish the risk.

Remember that, in the assessment of risks, Vanin should take various factors into account, namely available

scientific evidence; relevant processes and production methods; relevant inspection, sampling and testing

methods, among others.

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Vanin reunites a number of experts and establishes that the objectives of this risk assessment are to:

establish the unmitigated risk of food-borne Salmonellosis (e.g. the risk of taking no measure);

identify and consider the efficacy of some risk management interventions for addressing the problems

associated with Salmonella in eggs and egg products;

identify data needs, and prioritize future data collection efforts.

Vanin's final risk assessment model consisted of six modules:

Introduction and Methodology;

Hazard Identification;

Hazard Characterization of Salmonella Enteriditis;

Exposure Assessment of Samonella Enteriditis in Eggs and Egg Products;

Risk Characterization of Salmonella Enteriditis in Eggs and Egg Products;

Evaluation of Risk Mitigation measures for Salmonella Enteriditis.

Vanin's risk assessment determined that 5% of its shell eggs are usually infected with Salmonella Enteriditis.

The data also showed that of about 250.000 cases of illnesses registered every year, about 25.000 are cases of

human illness likely related to Salmonella Enteritidis in eggs.

Finally, the risk assessment identified various alternative measures which could be imposed, such as: requiring

that table eggs come only from poultry flocks tested to be free of Salmonella Enteritidis, or that eggs from

flocks of Salmonella Enteritidis be subject to precooking, or educating the public about the need to thoroughly

cook any foods containing eggs, etc., and the extent to which each of those measures might reduce the risk of

human illness.

Let us now move forward and examine the concept of "appropriate level of protection" under the

SPS Agreement.

EXERCISES:

3. According to WTO case law, especially the reports on the case EC – Hormones, how has the Members'

obligation to base a food safety measure on a risk assessment been interpreted, regarding the

1 - conduct of a risk a assessment, 2 - its timing, and 3 - the use of mainstream/diverging scientific

opinion?

4. What are the factors to be taken into account in the assessment of risks, according to Article 5.2 of the

SPS Agreement, as interpreted in WTO case law?

5. What are the economic factors to be taken into account in the assessment of risks to animal or plant life

or health, and when choosing the SPS measure to be applied to achieve a Member's appropriate level of

protection against such risks (Article 5.3 of the SPS Agreement)?

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III. THE APPROPRIATE LEVEL OF PROTECTION

(ALOP)

The definition of the concept appropriate level of protection (ALOP) is given by paragraph 5 of Annex A of the

SPS Agreement.

Let us take a look at it before describing the rights and obligations imposed by Article 5 on this matter.

Annex A.5 states:

Appropriate level of sanitary or phytosanitary protection – The level of protection deemed appropriate by

the Member establishing a sanitary or phytosanitary measure to protect human, animal or plant life or

health within its territory.

Note: Many Members otherwise refer to this concept as the "acceptable level of risk".

Members determine the level of risk they are willing to tolerate. The SPS Agreement does not require Members

to accept a level of protection lower than the one it has chosen, even if this result in fewer restrictions on

trade.

According to the level of risk considered acceptable by the Member – its appropriate level of SPS protection - it

will choose an SPS measure to achieve this level. Keep in mind that the choice of the level of protection is a

Member's sovereign decision subject to only a few disciplines set forth in Article 5 of the SPS Agreement.

Important note

In contrast, the choice of the measure to achieve the desired level of protection is subject to virtually all of

the disciplines of the SPS Agreement, including the basic obligation that the measure be base on scientific

evidence (and not maintained without sufficient scientific evidence) in Article 2, be based on international

standards (unless there is a scientific justification for not doing so) in Article 3, be based on a risk

assessment in Article 5, be published and notified in Article 7, etc.

We shall analyse Members' obligations regarding the choice of the measure to achieve the desired level of

protection, namely those set forth in Article 5 paragraphs 4, 5 and 6.

III.A. OBJECTIVE OF MINIMIZING NEGATIVE TRADE EFFECTS

IN DETAIL

Article 5.4 reads:

Members should, when determining the appropriate level of sanitary and phytosanitary protection, take

into account the objective of minimizing negative trade effects.

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Article 5.4 provides that Members should take into account the objective of minimizing negative trade effects,

when choosing their appropriate level o protection. The use of the term "should" rather than "shall" indicates

that this is a hortative provision, containing no binding obligation on Members, but encouraging them to

consider the trade effects of their choice of level of protection, as stated by the Panel in the EC – Hormones

case report.

ILLUSTRATION

Taking into consideration the example above, on the risks associated with Salmonella Enteridis in shell eggs

and egg products, we would like to discuss the choice of appropriate level of protection by Vanin.

First of all, through the risk assessment procedure, the existence of a risk was verified:

Vanin's risk assessment determined that 5 per cent of its shell eggs are usually infected with Salmonella

Enteriditis, and that this results in about 25.000 cases of human illness each year.

As we know, Vanin has to determine its appropriate level of protection having in mind the goal of minimizing

negative trade effects.

The baseline egg products model used in Vanin's risk assessment predicts that the probability is low that any

cases of Salmonella Enteritidis will result from the consumption of pasteurized egg products. However, Vanin's

current time and temperature regulations do not provide sufficient guidance to the egg products industry for

the large range of products the industry produces. Time and temperature standards based on the amount of

bacteria in the raw product, how the raw product will be processed, and the intended use of the final product

will provide greater protection to the consumers of egg products. Vanin may decide on its appropriate level of

protection bearing in mind the information above. It may decide that it should have no more than 5.000 cases

of human illness a year related to Salmonella Enteritidis in eggs, and no more than 1% infected shell eggs.

Concerning the choice of the measure, Vanin may require that all eggs products, including imported ones, be

pasteurized and treated at certain temperatures. As for shell eggs, requirements that these be taken to low

temperatures before being put on the market may reduce the incidence of Salmonella. The specific

requirements will depend on the appropriate level of protection Vanin sets, i.e. the level of risk it believes it

can tolerate.

EXERCISES:

6. Who sets the appropriate level of SPS protection, or the acceptable level of risk?

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III.B. CONSISTENCY

Unlike Article 5.4, Article 5.5 of the SPS Agreement contains a binding obligation, which disciplines Members'

choice of appropriate level of protection. Article 5.5 reads:

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. (emphasis

added)

The consistency requirement, articulated in Article 5.5, means that Members must avoid unjustifiable

differences in the level of health protection they require in different situations, if such differences result in

discrimination or a disguised restriction on international trade. For example, if a Member restricts the

importation of one animal product because of disease risks, yet allows the importation of other animals

presenting identical or similar risks, there would be a concern that the distinctions are a disguised restriction

on international trade.

Two features of Article 5.5 may be singled out:

the goal of achieving consistency in the application of the concept of appropriate level of SPS

protection; and

the legal obligation to avoid arbitrary or unjustifiable distinctions in the levels of protection considered

to be appropriate in different situations, if these distinctions result in discrimination or disguised trade

restrictions.

In EC – Hormones, the Appellate Body discussed both features. On the first one, it held that the goal is not

absolute or perfect consistency, but only the avoidance of arbitrary or unjustifiable inconsistencies, to be

achieved in the future, through the development of guidelines by the SPS Committee.

On the second, which is an immediate obligation, the Appellate Body stated that a violation may be

demonstrated if three cumulative elements are fulfilled:

the Member has adopted its own appropriate levels of SPS protection against risks to human life or

health in several different situations;

those levels of protection exhibit arbitrary or unjustifiable differences (or "distinctions" in the language

of Article 5.5) in their treatment of different situations; and

the arbitrary or unjustifiable differences result in discrimination or a disguised restriction of international

trade (referring to the effect of the application of the measure embodying or implementing a particular

level of protection).

17

Since these requirements are cumulative, the mere proof of different treatment in different situations is not

sufficient, although it might serve as a warning signal that the implementing measure in its application might

be discriminatory or a disguised restriction on trade.

We are going to analyse each of these conditions below.

III.B.1. LEVEL OF PROTECTION IN DIFFERENT SITUATIONS

In the EC – Hormones case, the Appellate Body found that situations exhibiting differing levels of protection

can only be compared if they present some common element or elements sufficient to render them

comparable. If the situations proposed for examination are totally different from one another, they would not

be rationally comparable and the differences in levels of protection could not be examined for arbitrariness.

In the Australia - Salmon case, the Appellate Body noted that situations involving a risk of entry, establishment

or spread of the same or a similar disease, or situations with a risk of the same or similar associated potential

biological and economic consequences, have sufficient common elements to render them comparable under

Article 5.5. For different situations to be comparable under Article 5.5, it is not necessary for both the disease

and the biological and economic consequences to be the same or similar, similarity of either one or the other

set of characteristics should suffice to render them comparable.

Note

Thus, to establish if the first requirement has been met, it is necessary to determine whether a Member has

imposed different levels of protection in different but comparable situations.

The question is then: "How to ascertain the level of SPS protection chosen by a Member?"

In Australia – Salmon, the Appellate Body addressed the question of how to ascertain the level of sanitary

protection chosen by a Member and found that:

Members have an implicit obligation under the SPS Agreement to positively determine their appropriate

level of protection;

There is no obligation to determine it in quantitative terms;

In cases where a Member does not determine its appropriate level of protection, or does so with

insufficient precision, such level may be established by panels on the basis of the level reflected in the

SPS measure actually applied.

The Panel in this case had noted that "imposing the same sanitary measure for different situations does not

necessarily result in the same level of protection". The Appellate Body did not disagree with this observation.

III.B.2. ARBITRARY OR UNJUSTIFIABLE DIFFERENCES

The second step in the test for a violation of Article 5.5 is that a Member applies arbitrary or unjustifiable

distinctions in the levels of protection.

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The panels and the Appellate Body, namely in the cases EC – Hormones and Australia – Salmon, examined

whether there were reasons to justify the differences in levels of protection, and recognized that several

situations may justify such differences, inter alia:

the two situations compared involved different levels of risk; or

the difficulty of controlling the risks differed in each case; or

the degree of government intervention necessary to achieve the same level of protection in each case

differed.

In such cases, among others, differences would likely be seen as justifiable.

III.B.3. DISCRIMINATION OR DISGUISED RESTRICTION ON TRADE

In Australia – Salmon, the Appellate Body agreed with the Panel's identification of three "warning signs" with

respect to the issue of whether a disguised restriction on trade arises from the distinct levels of protection

adopted by a Member:

the arbitrary character of the differences in levels of protection (that is, that the second requirement for

the violation of Article 5.5 is met);

a rather substantial difference in levels of protection; and

cumulative findings of inconsistency with both Article 5.1 and 2.2 (on the absence of scientific

justification) which indicate that the measure at issue constitutes a restriction on international trade,

disguised as a sanitary measure.

In the EC – Hormones case, the Appellate Body pointed out that the phrase "discrimination or a disguised

restriction on international trade", as provided for in Article 5.5, has to be interpreted in the context of the

basic obligations of Members contained in Article 2.3, which requires that SPS measures shall not be applied in

a manner which would constitute a disguised restriction on international trade. However, the Appellate Body

disagreed with the Panel's finding which considered pertinent, in the analysis of the above-mentioned terms,

the jurisprudence under Articles III and XX of the GATT.

The Appellate Body explained its reluctance to apply its jurisprudence under Article III:2 of GATT to Article 5.5

of the SPS Agreement by noting that a tax differential is very different from a differential in levels of

protection. While there is a "clear and linear relationship" between a tax differential and protection given to

domestic products, no such clear relationship exists between differentials of levels of protection of human

health and protection given to domestic products.

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The magnitude of the difference 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 results from the application of a measure or measures embodying those different levels of protection.

Whether arbitrary or unjustifiable differences result in discrimination or a disguised restriction has to be

determined bearing in mind the circumstances of each individual case.

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III.B.4. SPS COMMITTEE GUIDELINES ON THE IMPLEMENTATION OF

ARTICLE 5.5

In June 2000, the SPS Committee adopted the "Guidelines to Further the Practical Implementation of

Article 5.5" (G/SPS/15). The guidelines are intended to provide assistance to Members in the application of the

concept of consistency in appropriate levels of protection and in the adoption and implementation of SPS

measures.

These guidelines address the two elements within Article 5.5 and reflect the interpretations and clarifications

resulting from case law, in particular the occurrence of the "warning signals" mentioned above as a possible

indication of a violation of Article 5.5.

The main recommendations contained in the Guidelines are that Members should:

clearly indicate the level of protection considered appropriate with respect to risks to human, animal or

plant life or health, so as to allow an examination of whether any SPS measure achieves that level;

establish common approaches or consistent procedures for use by the authorities assessing risks and

evaluating the measures which might be applied to achieve the desired levels of protection;

when determining an appropriate level of protection, either broadly or specifically, consider (i) if there is

a difference between levels being determined and already determined by a Member in different

situations, and, if so, (ii) if it is arbitrary or unjustifiable, and, if so, (iii) if it may result in discrimination

or in a disguised restriction on international trade;

establish clear and effective communication and information flows within and between the authorities

responsible for the determination of appropriate levels of protection, and between these and those

responsible for choosing and implementing the SPS measure designed to achieve it;

compare any proposed decision on the level of protection in a particular situation with the level

previously considered appropriate; and compare any proposed measure intended to achieve the

appropriate level of protection in a particular situation with other SPS measures previously taken, or

being considered, in situations which contain sufficient common elements so as to render them

comparable;

clearly identify those situations which they consider justify their acceptance exceptionally of a lower

level of protection for human health, specifically with respect to risks to which people voluntarily expose

themselves;

in determining a new or modified appropriate level of protection: review their previous decisions in this

regard, taking into account current decisions and developments; examine any relevant international

standards, guidelines or recommendations, or decisions taken by other Members facing similar risks and

situations; and consider seeking expert advice to contribute to the decision-making process;

in considering a measure to achieve an appropriate level of protection in a particular situation: routinely

review existing measures, taking also into account current decisions and developments; determine

whether a relevant international standard, guideline or recommendation exists, and if it does, whether

adoption of it would achieve the Member's appropriate level of protection; examine measures applied by

other Members facing similar risks and situations; consider seeking expert advice on the selection and

implementation of SPS measures to achieve it.

As you can see, many of these recommendations aim at achieving transparency. Further examples and

explanations are provided in the Guidelines, so as to assist Members in the implementation of their obligations

regarding consistency.

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The first review of the Guidelines was conducted as part of the Second Review of the SPS Agreement. It was

noted that Members had not raised any concerns related to the Guidelines since their adoption in July 2000.

Another review of the operations of the Guidelines will take place whenever Members identify the need, and in

any case not later than December 2008.

EXERCISES:

7. What is the obligation contained in Article 5.5, regarding 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?

8. In the light of WTO case law, when may a violation of Article 5.5 be found?

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III.C. MEASURE NO MORE TRADE RESTRICTIVE THAN

REQUIRED TO ACHIEVE THE ALOP

After having discussed Article 5.5, on Consistency, we now turn to Article 5.6, which addresses the condition

that a measure be no more trade restrictive than required to achieve a Member's appropriate level of SPS

protection.

Article 5.6 requires:

6. Without prejudice to paragraph 2 of Article 3, when establishing or maintaining sanitary or

phytosanitary measures to achieve the appropriate level of sanitary or phytosanitary protection,

Members shall ensure that such measures are not more trade-restrictive than required to achieve

their appropriate level of sanitary or phytosanitary protection, taking into account technical and

economic feasibility.(3)

Footnote 3. For purposes of paragraph 6 of Article 5, a measure is not more trade-restrictive than

required unless there is another measure, reasonably available taking into account technical and

economic feasibility, that achieves the appropriate level of sanitary or phytosanitary protection and is

significantly less restrictive to trade.

WTO Members choose not only their appropriate level of protection, but also the appropriate SPS measure to

achieve their level of protection. Article 5.6 obliges Members to adopt measures no more trade restrictive than

required to achieve the chosen level of SPS protection, considering technical and economic feasibility. This is a

discipline on the choice of the measure rather than on the determination of the appropriate level of protection.

For example, if a country wants to avoid the introduction of an insect associated with fruit imports, requiring

fumigation might be a less trade-restrictive alternative to an import ban.

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The appropriate level of protection established by a Member and the SPS measure have to be clearly

distinguished. The first is an objective, the second is an instrument chosen to attain or implement that

objective.

The Appellate Body in the case Australia - Salmon agreed with the Panel that Article 5.6 contains a

three-pronged test for determining whether a measure is more trade restrictive than required.

This is the case if there is another SPS measure which:

is reasonably available taking into account technical and economic feasibility;

achieves the Member's appropriate level of sanitary or phytosanitary protection; and

is significantly less restrictive to trade than the SPS measure contested.

These three elements are cumulative in nature.

A measure is reasonably available when the Member which adopts it has the resources or technical capacity to

do so. The reasonability is directly related to technical and economic feasibility. For example, a less trade

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restrictive measure which implies a high regulatory or compliance burden or which is impractical to implement

taking into account the level of development of the Member, is not "reasonably available".

Regarding the second requirement, the complaining Member has the burden to demonstrate, when invoking a

violation of Article 5.6, that an alternative measure which is less trade restrictive still achieves the importing

Member's appropriate level of protection. Although a Member may request another Member to adopt a different

SPS measure to tackle a certain risk, it cannot require a Member to change its appropriate level of protection

(Appellate Body report in Australia – Salmon).

Thus, taking the appropriate level of protection which was set by the importing Member into consideration, a

discontent Member has to demonstrate that another measure, less trade restrictive and reasonably available,

still achieves the appropriate level of protection of the former. The alternative measure has to be "significantly"

less trade restrictive. A small difference in the trade impacts of the two measures is not sufficient to oblige a

Member to adopt the alternative measure.

Great! So far we have learned a lot about risk assessment, the appropriate level of protection, and the choice

of an SPS measure.

Let us now turn our attention to the issue of provisional SPS measures under the SPS Agreement, and the role

of precaution.

EXERCISES:

9. What are Members' obligations regarding the objective of minimizing negative trade effects while

choosing the appropriate level of protection (Article 5.4) and the adoption of a measure no more trade

restrictive than required to achieve its appropriate level or protection (Article 5.6)?

10. When is a measure more trade restrictive than required to achieve the appropriate level of SPS

protection?

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IV. PROVISIONAL MEASURES

The discipline of risk assessment, one of the basic obligations of the SPS Agreement, was developed to guide

action in the face of incomplete knowledge about risks to health. As it is virtually impossible to scientifically

prove the "safety" of a food or product, scientists rather seek evidence of any harm. Governments often act

with precaution, in order to protect society against potential risks, without waiting for the conclusive results of

scientific analysis.

Precaution is a notion which supports taking protective action before there is scientific proof of a risk; that is,

action should not be delayed simply because full scientific information is lacking. In the fields of food safety,

plant and animal health protection, precaution in the face of scientific uncertainty and incomplete scientific

knowledge has long been addressed through the use of safety margins and provisional measures.

IV.A. PROVISIONAL MEASURES

Article 5.7 permits the taking of provisional measures when there is insufficient scientific evidence to permit

the assessment of health risks. However, a Member must base its measure on the available pertinent

information, must seek the additional information necessary for a more objective assessment of the risk(s),

and review the SPS measure within a reasonable period of time.

Article 5.7 provides:

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.

Provisional measures could be taken, for example, as an emergency response to a sudden outbreak of an

animal disease suspected of being linked to imports, while further information about the source of the outbreak

and its extent are gathered. Another example is the case of new food processing techniques where sufficient

evidence regarding safety does not yet exist.

Article 5.7 was invoked in three cases:

Japan – Agricultural Products II (also referred to as Japan – Varietals, WT/DS76);

Japan – Apples (Japan – Measures Affecting the Importation of Apples, WT/DS245); and

EC – GMOs (European Communities — Measures Affecting the Approval and Marketing of Biotech

Products, WT/DS291, 292, 293).

We are going to analyse the Japan – Agricultural Products II dispute below.

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CASE STUDY: JAPAN – AGRICULTURAL PRODUCTS II (W T/DS 76) JAPAN - VARIETALS

Complaint by the United States

Third Parties: Brazil, European Communities, Hungary

On 7 April 1997, the United States requested consultations with Japan in respect of the latter's SPS testing

requirements applied to certain agricultural products.

Japan required the testing of each variety of apples, cherries, peaches, walnuts, apricots, pears, plums and

quinces for the efficacy of treatment against codling moth. The United States claimed that it was not necessary

to test each variety of a fruit for the efficacy of the treatment.

What did the Panel and the Appellate Body say?

Among other things, the Panel stated and the Appellate Body upheld that:

the variety testing requirement violated Article 2.2 since there was no rational relationship between the

scientific evidence submitted by Japan and the measure.

the exception provided in Article 5.7 did not apply since the Panel found no evidence that Japan had

actively sought to obtain additional information in order to review its measure within a reasonable

period of time, as required by Article 5.7.

The Appellate Body report in this case provides useful guidance in the interpretation of Article 5.7, by

proposing that four conditions must be cumulatively met (i.e. all of them must be complied with) for the

provision to be legitimately invoked:

An Article 5.7 SPS measure must be imposed in respect of a situation where relevant scientific

information is insufficient;

The provisional measure must be adopted on the basis of available pertinent information;

The Member adopting the measure must seek to obtain the additional information necessary for a more

objective assessment of risk; and

The Member must review the SPS measure accordingly within a reasonable period of time.

IV.A.1. INSUFFICIENT SCIENTIFIC EVIDENCE

Regarding the first requirement, the Appellate Body, in the dispute Japan – Apples, affirmed that "the notions

of 'relevance' and 'insufficiency' in the introductory phrase of Article 5.7 imply a relationship between the

scientific evidence and something else". It continued, in its report:

"(…) '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."

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Japan, in this case, had maintained that, despite considerable scientific evidence regarding fire blight, there

was still uncertainty about certain aspects of transmission of fire blight. The Appellate Body remarked that "the

application of Article 5.7 is triggered not by the existence of scientific uncertainty, but rather by the

insufficiency of scientific evidence", and that the two concepts are not interchangeable. It noted that, in that

case, the scientific evidence was rather conclusive.

SUFFICIENCY OF EVIDENCE NOT RELATED TO ALOP: THE GMO CASE

In the EC – Biotech case (European Communities — Measures Affecting the Approval and Marketing of Biotech

Products WT/DS291, 292, 293), the Panel did not agree with the argument that the insufficiency of scientific

evidence must be assessed with reference to the appropriate level of protection (ALOP) of the importing

Member. The Panel considered that scientists did not need to know a Member's "acceptable level of risk" in

order to assess objectively the existence and magnitude of a risk. On the other hand, the Panel found that a

Member's ALOP is definitely relevant in determining the SPS measure to be applied, if any, to protect a

Member from risks.

IV.A.2. MEASURE ADOPTED ON THE BASIS OF AVAILABLE PERTINENT

INFORMATION

This requirement has not as yet been interpreted in WTO case law.

IV.A.3. SEEK TO OBTAIN ADDITIONAL INFORMATION

Regarding the third requirement, the Appellate Body in Japan – Agricultural Products II stated that the

additional information to be sought must be "germane" to conducting a more objective risk assessment. It held

that:

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.

IV.A.4. REVISION WITHIN A REASONABLE PERIOD OF TIME

The last requirement refers to the obligation to review the measure within a reasonable period of time. Thus,

this Article creates only a time-limited exemption from the normal SPS disciplines, pending review of the

measure in the light of new evidence.

The Appellate Body in Japan – Agricultural Products II stated that the reasonable period of time has to be

established on a case-by-case basis, having regard to the specific circumstances of the case and the difficulty

of obtaining additional information necessary for the review, and the characteristics of the provisional SPS

measure. This is important to give Members room for manoeuvre in cases where the insufficiency of scientific

26

evidence persists for extended periods or where the risks involved are expected to materialize only in the long

term. Therefore, reasonability will have to be interpreted on a case-by-case basis.

IV.B. THE PRECAUTIONARY PRINCIPLE

The "precautionary principle", or "precautionary approach", has been incorporated into several international

environmental agreements, and some claim that it is now recognized as a general principle of international

environmental law. However, in the EC - Hormones dispute, the Appellate Body noted that the "precautionary

principle" was reflected in the SPS Agreement, but that it did not override the specific obligations in the

Agreement. The Appellate Body considered that the notion of precaution was, in particular, incorporated in

paragraph 6 of the Preamble, Article 3.3, and Article 5.7 of the SPS Agreement.

Paragraph 6 of the Preamble embraces precaution by encouraging harmonization of national SPS measures

with international standards without requiring Members to change their sovereignly-determined appropriate

levels of health protection. Article 3.3 of the SPS Agreement entails a precautionary approach because it

explicitly permits Members to adopt SPS measures which are more stringent than measures based on the

relevant international standards.

As stated above, Article 5.7 allows Members to take provisional measures when sufficient scientific evidence

does not exist to permit a final decision on the safety of a product or process. The provisional measure must

take into consideration available pertinent information and the Member adopting the measure must seek to

obtain the additional information necessary for a more objective assessment of risk, and review the SPS

measure within a reasonable period of time.

An interesting situation happened in the EC – Hormones dispute: The European Communities did not actually

invoke Article 5.7, but rather stressed that its import ban was not a provisional measure. Instead, the EC

argued that the precautionary principle as a "general customary rule of international law or at least a general

principle of law", was applicable to the interpretation of the scientific disciplines in the SPS Agreement, and

argued that Articles 5.1 and 5.2 on risk assessment did not prevent Members from being cautious when setting

health standards in the face of conflicting scientific evidence and uncertainty.

EXERCISES:

11. What are the disciplines concerning provisional measures and a precautionary approach in the

SPS Agreement?

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V. REGIONALIZATION

The existence or spread of pests and diseases is often determined by geographic and ecological conditions

rather than political borders. This may be the case either due to variations in climatic, environmental or

geographic conditions within a country or due to the efforts of the regulatory authorities to eradicate a pest or

disease from specific areas.

In the past, it was common for an importing country to ban products from an entire country when it was

established that a pest or disease of significance for the importing country occurred, even if its prevalence was

limited to certain regions. This approach is changing, however, as it would violate Article 6 of the

SPS Agreement, on regionalization.

Article 6, on regionalization, aims to promote recognition of pest – or disease – free areas and areas of low

prevalence of pest or diseases. If importing countries adapt their SPS measures to the conditions prevailing in

the region of origin of the product, this may greatly improve market access possibilities, and avoid unnecessary

import bans.

IN DETAIL

Article 6.1 states:

1. Members shall ensure that their sanitary or phytosanitary measures are adapted to the sanitary or

phytosanitary characteristics of the area — whether all of a country, part of a country, or all or parts

of several countries — from which the product originated and to which the product is destined. In

assessing the sanitary or phytosanitary characteristics of a region, Members shall take into account,

inter alia, the level of prevalence of specific diseases or pests, the existence of eradication or control

programmes, and appropriate criteria or guidelines which may be developed by the relevant

international organizations.

Article 6 of the SPS Agreement recognizes the concepts of pest- or disease-free areas, and areas of low pest or

disease prevalence. Annex A of the Agreement introduces the two terms which are relevant in the analysis of

regionalization:

6. Pest – or disease-free area – An area whether all of a country part of a country or all or parts of

several countries as identified by the competent authorities in which a specific pest or disease does

not occur.

Note: A pest – or disease-free area may surround be surrounded by or be adjacent to an area –

whether within part of a country or in a geographic region which includes parts of or all of several

countries – in which a specific pest or disease is known to occur but is subject to regional control

measures such as the establishment of protection surveillance and buffer zones which will confine or

eradicate the pest or disease in question.

7. Area of low pest or disease prevalence – An area whether all of a country part of a country or all or

parts of several countries as identified by the competent authorities in which a specific pest or disease

occurs at low levels and which is subject to effective surveillance control or eradication measures.

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Such concepts are essential to maintain trade flows from non-infected or surveyed/controlled areas, therefore

preventing importing Members from denying access to goods from such areas, even if a disease prevails

elsewhere in the exporting country(ies).

Similar to the provisions for equivalence, it is the exporting Member's burden to prove the disease-free status

that it claims for the region, and to grant access to the importing Member for investigation of this claim

(Article 6.3).

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The OIE and the IPPC have developed guidelines on regionalization and the recognition of pest – or disease

– free status by importing countries, in their respective fields of action. Such organizations also serve as a

forum for discussions. For your reference:

(i) see the work developed by the OIE on zoning. At the OIE, regionalization is referred to as zoning and

compartmentalization. Requirements for obtaining disease free status are described in Section 1.3.5 of

the Terrestrial Animal Health Code and Section 1.4.4 of the Aquatic Code. In addition to providing

disease-specific information in relevant Chapters of the Codes, the OIE officially recognizes free status

for four diseases (Rinderpest, Foot and Mouth disease, BSE, and Contagious Bovine Pleuropneumonia);

(ii) see the work developed by the IPPC on Pest Free Area Plants, whose relevant standards are

ISPM 4 (1995) – Requirements for the Establishment of Pest Free Areas; ISPM 10 (1999) –

Requirements for the establishment of pest free places of production and pest free production sites;

ISPM 22 (2005) – Requirements for the establishment of areas of low pest prevalence. At the 2007

meeting, the IPPC started to discuss the possibility to introduce a mechanism for the recognition of pest

(disease) -free areas for plant diseases; ISPM 29 (2007) - Recognition of pest free areas and areas of

low pest prevalence.

IF YOU WANT TO KNOW MORE

ZONING AND COMPARTMENTALIZATION AT THE OIE

For the purposes of the OIE Terrestrial Code, 'zoning' and 'regionalisation' have the same meaning.

Given the difficulty of establishing and maintaining a disease free status for an entire country, especially for

diseases the entry of which is difficult to control through measures at national boundaries, there may be

benefits to Member Countries in establishing and maintaining a subpopulation with a different animal health

status within national boundaries. Subpopulations may be separated by natural or artificial geographical

barriers, or in certain animal industries, by the application of appropriate management systems, including

biosecurity management.

Zoning and compartmentalisation are procedures implemented by a country under the provisions of the OIE

Terrestrial Code with a view to defining subpopulations of different animal health status within its territory

for the purpose of disease control and/or international trade. Compartmentalisation applies to a

subpopulation when management systems related to biosecurity (i.e. by site) are applied, while zoning

applies when a subpopulation is defined on a geographical basis.

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V.A. OBLIGATIONS REGARDING REGIONALIZATION

V.A.1. FACTORS TO BE TAKEN INTO ACCOUNT

In determining what the sanitary or phytosanitary characteristics of a region are, Article 6.1 obliges Members

to take into account:

the level of prevalence of specific pests or diseases;

the existence of eradication or control programmes; and

appropriate criteria or guidelines developed by international organizations.

However, the list of factors in Article 6.1 is not exhaustive, and Members may utilise other factors for

determining regional characteristics.

V.A.2. PEST - OR DISEASE - FREE AREAS OR AREAS OF LOW PEST OR

DISEASE PREVALENCE

Article 6.2 specifically creates the obligation on Members to recognize the concepts of pest - or disease - free

areas and areas of low pest or disease prevalence, set forth in Annex A of the SPS Agreement and stated

above.

The determination of such areas shall be based on factors such as:

geography;

ecosystems;

epidemiological surveillance; and

the effectiveness of SPS controls.

The list of factors in Article 6.2 is not exhaustive either.

V.A.3. OBLIGATIONS OF EXPORTING MEMBERS

Article 6.3 provides that an exporting Member that claims that areas within its territory are pest - or disease -

free or have low pest or disease prevalence must provide the necessary evidence of this fact to the importing

Member. For this purpose, it must give the importing Member reasonable access for inspection, testing and

other relevant procedures.

V.B. THE WORK OF THE SPS COMMITTEE ON

REGIONALIZATION

For fruit exporters, market access often depends on the recognition of areas free from fruit flies, just as for

meat exporters it can depend on recognition of freedom from foot and mouth disease. In order to ensure that

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an area is free of pests or diseases and to prove that this is so, countries often have to invest large amounts of

money and resources and comply with lengthy procedures. This situation is even more difficult (and costly) if

the pest or disease must first be eradicated in the area. For the investment to be worthwhile, countries need to

be sure that their efforts will result in increased market access.

In the First Review of the SPS Agreement in 1999 (G/SPS/12), the Committee noted that the recognition of

pest or disease-free areas or areas of low pest or disease prevalence could facilitate trade in agricultural

products. On that occasion, the Committee noted Members faced difficulties in implementing the provisions of

Article 6, including excessively lengthy administrative processes for recognition in importing countries,

divergences in interpretation and implementation of international guidelines, and complexities involved in risk

assessment.

The Committee initiated substantive discussions on this matter in 2003 (ongoing), focusing on two aspects of

regionalization:

the establishment of pest – or disease – free areas by exporters; and

the recognition of the pest - or disease – free status by importing countries.

The discussions are, at present, more focused on the second item. See documents G/SPS/R/38,

G/SPS/GEN/636/Rev.1 and G/SPS/GEN/640/Rev.1 to learn more.

Note

Both the IPPC and the OIE have provided guidance for countries seeking to establish, or to be recognized

for pest – or disease – free status, as mentioned above.

During the Second Review of the SPS Agreement (G/SPS/36), Members recommended that the Committee

should maintain regionalization as a standing item of the agenda for its regular meetings and that it should

develop a proposal for a decision on the effective application of Article 6, taking into consideration the

discussions and the various proposals submitted by Members to the Committee (G/SPS/R/38). There was also

discussion of defining maximum timeframes for the recognition process, so as to avoid undue delays.

In May 2008, the SPS Committee adopted the "Guidelines to further the practical implementation of Article 6 of

the Agreement on the Application of Sanitary and Phytosanitary Measures" (G/SPS/48). These guidelines are

intended to provide assistance to Members implementing Article 6 of the SPS Agreement, by improving

transparency, exchange of information, predictability, and confidence and credibility between importing and

exporting Members. Thus, the guidelines provide with a number of actions and steps for Members to consider

when analyzing a request of an exporting Member for the recognition of a pest- or disease-free area or area of

low pest or disease prevalence.

31

Important note

It is not always feasible to regionalize. For example, in the field of animal health, the OIE has noted that

some diseases, due primarily to the way in which they are transmitted, are not suited to the application of

the concept of zoning (regionalization by geographic areas) or compartmentalization (regionalization by

production sites).

Furthermore, while the implementation of regionalization requires substantial involvement of the private

sector, with a high level of trust between the private and the public sectors, it is on the veterinary

administrators of the exporting country that the heavy burden falls. It has been noted by several Members

that there is a direct relationship between the speed at which disease free status is recognized and the

reliability of the exporter's veterinary services.

IF YOU WANT TO KNOW MORE

REGIONALIZATION

Check the website dedicated to the SPS Enhanced Informal Meeting on Article 6, organized by the

SPS Committee and held in January 2006, immediately before the regular meeting of SPS Committee. The

objective was to provide Members with the opportunity to present and discuss experiences in the area of

regionalization and the implementation of Article 6 of the SPS Agreement.

The summary of this special meeting may be found in document G/SPS/R/38.

At the meeting's website you will find a list of papers prepared by Members for this meeting (Mexico, Japan,

Argentina, Peru, Brazil, Chile, Colombia, Canada, Ecuador, Egypt, United States and European

Communities) and the presentations made by Members and observer organizations, which include

presentations by:

1. Argentina

2. Brazil

3. European Communities

4. Germany

5. Netherlands

6. OIE

7. Sweden

ILLUSTRATION

As an illustration of this concept, we will present Germany's efforts to manage Classical Swine Fever, as

reported in the Summary of the Special Meeting on Article 6 (regionalization), held on 30-31 January 2006.

See Germany's presentation in full here.

Germany worked towards the eradication of classical swine fever in wild boars in the Rhineland-Palatinate area

(2002-2005). Classical Swine Fever (CSF) is a high mortality infectious disease of pigs (both domestic and

32

wild). Virus reservoirs in feral pigs have been the most common source of infection and oral vaccination of the

infected feral pig population is a key measure to control the spread and eradicate the disease.

To address the issue of virus reservoirs, Germany implemented a system of oral vaccination in which bait

containing vaccine were introduced about three times a year to wild pig populations.

The main elements for application of a successful regionalized approach to managing this disease included

(i) appropriate definition of the area, (ii) implementation of effective control measures and surveillance,

(iii) the conduct of risk assessments for specific commodities for trade, (iv) the conduct of audits and

inspections, and (v) supporting high quality of veterinary services.

In order to enhance mutual trust and transparency, throughout the process all stakeholders were kept

informed and a database was established containing results of tests for the disease. The efforts to regionalize

the control of this disease allowed trade from non-infected areas while at the same time supporting the

eradication of classical swine fever. In 2004, regionalization measures were lifted, after control measures found

0 cases of the virus.

Figure 1: CSF in wild and domestic pigs, 2002 – today

EXERCISES:

12. What are the main obligations concerning regionalization (Article 6) in the SPS Agreement?

33

VI. SUMMARY

MEMBERS ARE PERMITTED TO ADOPT SPS MEASURES WHICH ARE MORE STRINGENT THAN THE

RELEVANT INTERNATIONAL STANDARDS OR ADOPT SPS MEASURES WHEN INTERNATIONAL

STANDARDS DO NOT EXIST, PROVIDED THE MEASURES ARE

based on scientific risk assessment;

consistently applied; and

not more trade restrictive than necessary.

THERE ARE TWO TYPES OF RISK ASSESSMENT AS DEFINED BY ANNEX A.4 OF THE

SPS AGREEMENT

For risks arising from pests or diseases: 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 SPS

measures which might be applied, and of the associated potential biological and economic

consequences; or

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.

BOTH TYPES OF RISK ASSESSMENT SHOULD BE SPECIFIC (THAT IS, DEMONSTRATE MORE THAN A

GENERAL RISK OF HARM), AND COMPREHENSIVE (COVER EACH SUBSTANCE/PRODUCT AT ISSUE)

FURTHERMORE

Members are not obliged to base a measure on a risk assessment that represents mainstream

scientific opinion, they are allowed to take into account diverging scientific opinions from respected,

qualified sources (Appellate Body report in EC – Hormones);

Members are not required, under Article 5.1, to conduct their own risk assessment, and may base

their measures on a risk assessment carried out by another Member or by relevant international

organizations (Appellate Body report in EC – Hormones). Members are nonetheless responsible for the

appropriateness and comprehensiveness of the risk assessment on which they base a measure, which

should address the risk situation actually faced by the Member imposing the measure;

Members have an obligation to base a measure on a risk assessment, even if the measure was

enacted before the entry into force of the SPS Agreement. (Panel report in EC - Hormones). SPS

measures should not be maintained without sufficient scientific evidence, which means that a Member

should be able to provide scientific evidence (a risk assessment) for an SPS measure which is force

and is not based on an international standard, if so requested.

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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 and other treatment.

WHILE ASSESSING THE RISKS TO ANIMAL OR PLANT LIFE OR HEALTH, OR WHEN CHOOSING THE

SPS MEASURE TO BE APPLIED TO ACHIEVE ITS APPROPRIATE LEVEL OF PROTECTION, MEMBERS

SHALL TAKE INTO ACCOUNT

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.

APPROPRIATE LEVEL OF PROTECTION: THE LEVEL OF SPS PROTECTION DEEMED APPROPRIATE IS

SET BY THE MEMBER IMPOSING THE MEASURE

Members should take into account the objective of minimizing negative trade effects when choosing

their appropriate level of protection.

Members must avoid unjustifiable differences in the level of health protection they require in different

situations, if such differences result in discrimination or a disguised restriction on international trade.

The mere proof of different treatment in different situations is not sufficient to show a violation of this

Article, although it might serve as a warning signal that the implementing measure might be

discriminatory in its application, or a disguised restriction on trade.

Members shall adopt measures no more trade restrictive than what is required to achieve the chosen

level of SPS protection, considering technical and economic feasibility. A measure is more trade

restrictive than required if there is another measure which is reasonably available taking into account

technical and economic feasibility; achieves the Member's appropriate level of sanitary or

phytosanitary protection; and is significantly less restrictive to trade than the SPS measure contested

(Appellate Body in Australia – Salmon).

"GUIDELINES TO FURTHER THE PRACTICAL IMPLEMENTATION OF ARTICLE 5.5"

In June 2000, the SPS Committee adopted the "Guidelines to Further the Practical Implementation of

Article 5.5" (G/SPS/15). The guidelines are intended to provide assistance to Members in the application of

consistency while deciding on the appropriate level of protection or on the adoption and implementation of

SPS measures.

THE ROLE OF PRECAUTION IN THE SPS AGREEMENT

Article 5.7 permits the taking of provisional measures on the basis of the available pertinent information

about the product or process health risk(s), when there is insufficient scientific evidence to permit a final

decision on its safety. However, a Member must seek the additional information necessary for a more

objective assessment of the risk(s), and review the SPS measure within a reasonable period of time.

35

FOUR CONDITIONS MUST BE CUMULATIVELY MET FOR ARTICLE 5.7 TO BE LEGITIMATELY

INVOKED (APPELLATE BODY IN JAPAN – AGRICULTURAL PRODUCTS II)

The provisional SPS measure must be imposed in respect of a situation where relevant scientific

information is insufficient;

The provisional measure must be adopted on the basis of available pertinent information;

The Member adopting the measure must seek to obtain the additional information necessary for a

more objective assessment of risk; and

The Member must review the SPS measure accordingly within a reasonable period of time, which is

determined on a case-by-case basis.

REGIONALIZATION (ARTICLE 6)

Members shall ensure that their sanitary or phytosanitary measures are adapted to the sanitary or

phytosanitary characteristics of the area — whether all of a country, part of a country, or all or parts of

several countries — from which the product originated and to which the product is destined. The main

obligations regarding Regionalization are:

While determining SPS characteristics of a region, Members shall take into account, inter alia, the

level of prevalence of specific pests or diseases; the existence of eradication or control programmes;

and appropriate criteria or guidelines developed by international organizations.

Members have the obligation to recognize pest - or disease - free areas and areas of low pest or

disease prevalence established in other Members. The determination of such areas shall be based on

factors such as: geography, ecosystems, epidemiological surveillance, and the effectiveness of SPS

controls.

An exporting Member that claims that areas within its territory are pest - or disease - free or have low

pest or disease prevalence must provide the necessary evidence of this fact to the importing Member.

For this purpose, it must give the importing Member reasonable access for inspection, testing and

other relevant procedures.

36

PROPOSED ANSWERS:

1. In addition to the basic obligations set forth in Article 2, pursuant to Article 3 and Article 5 of the

SPS Agreement, Members are permitted to adopt SPS measures which are more stringent than the

relevant international standards or adopt SPS measures when international standards do not exist,

provided the measures are:

based on scientific risk assessment;

consistently applied; and

not more trade restrictive than necessary.

2. There are two types of risk assessment as defined by Annex A.4 of the SPS Agreement:

Risks arising from pests or diseases: 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 SPS

measures which might be applied, and of the associated potential biological and economic

consequences; or

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.

It is important to determine which definition of risk assessment is applicable in a particular situation, as

the requirements are different for each type. The category of SPS measure (which depends on its

objective) determines what the applicable type of risk assessment is.

On the common features, the risks covered in both types of risk assessment should be ascertainable and

specific, i.e., it is not sufficient for a risk assessment to show a general risk of harm. The risk assessment

should also be comprehensive and cover each of the products at issue. While the Panel on EC – Hormones

had held that a risk assessment would have to be carried out for each individual substance at issue, the

Panel on Australia – Salmon held that studies on one particular product category could be relevant for a

risk assessment in respect of another product category. Therefore, we may say that a risk assessment

undertaken for one category of product may be relevant to another category, if such products are subject

to the same or similar kind of risk.

3. 1. Members are not required to base a measure on a quantitative risk assessment but may instead rely

on a qualitative assessment of potential risks (EC - Hormones).

2. Members are not required, under Article 5.1, to conduct their own risk assessment, and may base

their measures on a risk assessment carried out by another Member or by relevant international

organizations (Appellate Body report in EC – Hormones). The risk assessment must nonetheless be

appropriate and comprehensive, that is, it should address the risk situation actually faced by the

Member imposing the measure.

3. Members have an obligation to base a measure on a risk assessment even if the measure was enacted

before the entry into force of the SPS Agreement. (Panel report in the EC - Hormones). SPS measures

should not be maintained without sufficient scientific evidence, which means that a Member should be

able to provide scientific evidence (a risk assessment) for an SPS measure which is in force and is not

based on an international standard, if so requested. Members are not obliged to base a measure on a

risk assessment that represents mainstream scientific opinion, they are allowed to use diverging

scientific opinions from respected, qualified sources (Appellate Body report in EC – Hormones).

37

4. 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 and other treatment.

According to the Appellate Body, Article 5.2 shows that a risk assessed 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" (Appellate Body report in EC – Hormones). The

Appellate Body further clarified that the list in Article 5.2 is not a closed one, and that risks related to

detection and control of compliance with certain requirements (such as the failure to observe good

veterinary practice) may also be taken into account as part of the risk assessment.

5. Article 5.3 lists various economic factors a Member has to take into account while assessing risks to

animal or plant life or health, and when choosing the SPS measure to be applied to achieve its

appropriate level of protection against such risks:

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.

Members are not required to take economic factors into consideration while choosing a measure to

protect human life or health.

6. The level of SPS protection deemed appropriate is set by the Member imposing the measure.

Members determine the level of risk they are willing to tolerate. The SPS Agreement does not require

Members to accept a level of protection lower than the one it has chosen, even if this would be more

trade creating.

According to the level of risk considered acceptable by the Member – or the appropriate level of SPS

protection - it will choose an SPS measure to achieve this level. However, this choice is subject to certain

disciplines set forth in Article 5 of the SPS Agreement, namely paragraphs 4, 5 and 6 of this Article.

7. The consistency requirement, articulated in Article 5.5, means that Members must avoid unjustifiable

differences in the level of health protection they require in different situations, if such differences result in

discrimination or a disguised restriction on international trade. For example, if a Member restricts the

importation of one animal product because of disease risks, yet allows the importation of other animal

products presenting identical or similar risks, there would be a concern that the distinctions could be a

disguised restriction on international trade.

38

Two features of Article 5.5 may be singled out:

the goal of achieving consistency in the application of the concept of appropriate level of SPS

protection; and

the legal obligation to avoid arbitrary or unjustifiable distinctions in the levels of protection

considered to be appropriate in different situations, if these distinctions result in discrimination or a

disguised trade restriction.

8. In EC – Hormones, the Appellate Body stated that a violation of the binding obligations of Article 5.5 may

be demonstrated if three cumulative elements are fulfilled:

the Member has adopted its own appropriate levels of SPS protection against risks to human life or

health in several different situations. These situations must be comparable;

those levels of protection exhibit arbitrary or unjustifiable differences (or distinctions in the language

of Article 5.5) in their treatment of different situations. Reasons which justify differences in levels of

protection may involve the difficulty of controlling the risks in each case, or the degree of

government intervention necessary to achieve the same level of protection; and

the arbitrary or unjustifiable differences result in discrimination or a disguised restriction of

international trade (referring to the effect of the application of the measure embodying or

implementing a particular level of protection). The "discrimination or a disguised restriction on

international trade", as provided for in Article 5.5, has to be interpreted in the context of the basic

obligations of Members contained in Article 2.3, which requires that SPS measures shall not be

applied in a manner which would constitute a disguised restriction on international trade. Whether

arbitrary or unjustifiable differences result in discrimination or a disguised restriction on trade has to

be determined bearing in mind the circumstances of each individual case.

The mere proof of different treatment in different situations is not sufficient, although it might serve as a

warning signal that the implementing measure in its application might be discriminatory or a disguised

restriction on trade.

9. Article 5.4 provides that Members should take into account the objective of minimizing negative trade

effects, when choosing their appropriate level o protection. This is a hortative provision, containing no

binding obligation on Members, but encouraging them to consider the trade effects of their choice of level

of protection.

Article 5.6 deals with the choice of SPS measure and requires Members to adopt measures no more trade

restrictive than required to achieve the chosen level of SPS protection, considering technical and

economic feasibility. This is a discipline on the choice of the measure rather than on the selection of the

appropriate level of protection.

The appropriate level of protection established by a Member and the SPS measure have to be clearly

distinguished. The first is an objective, the second is an instrument chosen to attain or implement that

objective.

10. The Appellate Body in the case Australia - Salmon agreed with the Panel that Article 5.6 contains a

three-pronged test for qualifying whether a measure is more trade restrictive than required. This is the

case if there is another SPS measure which:

is reasonably available taking into account technical and economic feasibility;

achieves the Member's appropriate level of sanitary or phytosanitary protection; and

39

is significantly less restrictive to trade than the SPS measure contested.

These three elements are cumulative in nature. The burden of proof rests on the complaining party to

demonstrate that an alternative measure, significantly less trade restrictive than the SPS measure

contested, achieves the appropriate level of SPS protection of the respondent.

11. Article 5.7 permits the taking of provisional measures on the basis of the available pertinent information

about the product or process health risk(s), when there is insufficient scientific evidence to permit a final

decision on its safety. However, a Member must seek the additional information necessary for a more

objective assessment of the risk(s), and review the SPS measure within a reasonable period of time.

The Appellate Body report in the case Japan – Agricultural Products II provides useful guidance in the

interpretation of Article 5.7, by proposing that four conditions must be cumulatively met for the provision

to be legitimately invoked:

An Article 5.7 SPS measure must be imposed in respect of a situation where relevant scientific

information is insufficient;

The provisional measure must be adopted on the basis of available pertinent information;

The Member adopting the measure must seek to obtain the additional information necessary for a

more objective assessment of risk; and

The Member must review the SPS measure accordingly within a reasonable period of time, which is

determined on a case-by-case basis.

12. Members shall ensure that their sanitary or phytosanitary measures are adapted to the sanitary or

phytosanitary characteristics of the area — whether all of a country, part of a country, or all or parts of

several countries — from which a product originates and to which a product is destined.

While determining SPS characteristics of a region, Members shall take into account, inter alia, the level of

prevalence of specific pests or diseases; the existence of eradication or control programmes; and

appropriate criteria or guidelines developed by international organizations.

Article 6.2 specifically creates the obligation on Members to recognize the concepts of pest - or disease -

free areas and areas of low pest or disease prevalence, set forth in Annex A of the SPS Agreement. The

determination of such areas shall be based on factors such as: geography, ecosystems, epidemiological

surveillance, and the effectiveness of SPS controls.

Article 6.3 provides that an exporting Member that claims that areas within its territory are pest - or

disease - free or have low pest or disease prevalence must provide the necessary evidence of this fact to

the importing Member. For this purpose, it must give the importing Member reasonable access for

inspection, testing and other relevant procedures.

40

Videos E-Learning short videos – TBT/SPS -

http://etraining.wto.org/admin/files/Course_278/Videos/SPS_TBT_PartI.mp4

E-Learning short videos – TBT/SPS -

http://etraining.wto.org/admin/files/Course_278/Videos/SPS_TBT_PartII.mp4

The SPS Agreement - http://etraining.wto.org/admin/files/Course_278/Videos/SPS.mp4

Trading safely: Protecting health, promoting development -

http://WTO.http.internapcdn.net/WTO/flash/2009_07_21_trading_hr_e.mp4

Other videos - http://www.youtube.com/user/WTO