Sanitary and Phytosanitary Measures

Module

6

Risk Assessment, Appropriate Level of Protection, Consistency, Provisional Measures and Regionalization in the SPSAgreement

ESTIMATED TIME: 7 hours

OBJECTIVES OF MODULE 6

§  Present the obligations regarding risk assessment and the determination of the appropriate level of protection contained in the SPSAgreement, including the disciplines regarding consistency and provisional measures. (Article5);

§  Explain the subject as interpreted in WTO Dispute Settlement;

§  Explain the obligations related to regionalization (Article6);

I.  INTRODUCTION

As already explained, 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 Article2 and further elaborated in other provisions. Essentially, countries may adopt SPS measures provided these:

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

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

ú  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:

ú  base their measures on international standards; OR

ú  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.

In the previous Module, we learned about "harmonization". Harmonization is a central discipline in the SPSAgreement 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

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

ú  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".

The two main rights are that

ú  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 SPSAgreement.

ú  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 Article5 of the SPSAgreement.

AnnexA.3 of the SPSAgreement 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.

So, it is time to start Module6! 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 SPSAgreement.

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!

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 SPSAgreement simply because they differ from international norms.

According to Article3 and Article5 of the SPSAgreement, 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 Article2, are:

ú  based on scientific risk assessment;

ú  consistently applied; and

ú  not more trade restrictive than necessary.

Article5 disciplines the "assessment of risk and the determination of the appropriate level of sanitary and phytosanitary protection". Article5.1 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 Article5.1, 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:
ú  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
ú  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 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

ú  Australia – Measures affecting importation of Salmon

ú  Complaint by Canada

ú  Respondent: Australia

ú  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 SPSAgreement, and also nullified or impaired benefits accruing to Canada under the SPSAgreement.

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 SPSAgreement but nevertheless found that:

ú  Australia had acted inconsistently with Articles 5.1 and 2.2 of the SPSAgreement;

ú  broadened the Panel's finding that Australia had acted inconsistently with Articles5.5 and 2.3 of the SPSAgreement;

ú  reversed the Panel's finding that Australia had acted inconsistently with Article5.6 of the SPSAgreement but was unable to come to a conclusion whether or not Australia's measure was consistent with Article5.6 due to insufficient factual findings by the Panel.

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:

ú  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;

ú  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

ú  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 SPSAgreement.

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), presented in Module5, 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:

ú  identification of the adverse effects on human (or animal, as the case may be) health arising from the presence of additives, contaminants, etc.; AND

ú  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 AnnexA of the SPSAgreement. 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.

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 Article5.1, 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 ECHormones 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 SPSAgreement in WTO case law. The Section on Article5.1 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 SPSAgreement? What are their common features, according to WTO case law?

II.B.  OBLIGATIONS REGARDING RISK ASSESSMENT

Let us now examine Article5 of the SPSAgreement in detail.

II.B.1.  Obligation to base SPS measures on a risk assessment

IN DETAIL

As we mentioned above, Article5.1 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 CodexAlimentarius Commission, the OIE and the IPPC. We learned in Module4 how the term "base on" has been interpreted in WTO case law.

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. Article5.1 read together with Article2.2 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 Article5.1. 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 AustraliaSalmon, WT/DS18).

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: