WTO ANALYTICAL INDEX: SANITARY AND PHYTOSANITARY MEASURES

Agreement on Sanitary and Phytosanitary Measures

The texts reproduced here do not have the legal standing of the original documents which are entrusted and kept at the WTO Secretariat in Geneva.

 

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I. Preamble 

A. Text of the Preamble

   Members,

 

   Reaffirming that no Member should be prevented from adopting or enforcing measures necessary to protect human, animal or plant life or health, subject to the requirement that these measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail or a disguised restriction on international trade;

 

   Desiring to improve the human health, animal health and phytosanitary situation in all Members;

 

   Noting that sanitary and phytosanitary measures are often applied on the basis of bilateral agreements or protocols;

 

   Desiring the establishment of a multilateral framework of rules and disciplines to guide the development, adoption and enforcement of sanitary and phytosanitary measures in order to minimize their negative effects on trade;

 

   Recognizing the important contribution that international standards, guidelines and recommendations can make in this regard;

 

   Desiring to further the use of harmonized sanitary and phytosanitary measures between Members, on the basis of international standards, guidelines and recommendations developed by the relevant international organizations, including the Codex Alimentarius Commission, the International Office of Epizootics, and the relevant international and regional organizations operating within the framework of the International Plant Protection Convention, without requiring Members to change their appropriate level of protection of human, animal or plant life or health;

 

   Recognizing that developing country Members may encounter special difficulties in complying with the sanitary or phytosanitary measures of importing Members, and as a consequence in access to markets, and also in the formulation and application of sanitary or phytosanitary measures in their own territories, and desiring to assist them in their endeavours in this regard;

 

   Desiring therefore to elaborate rules for the application of the provisions of GATT 1994 which relate to the use of sanitary or phytosanitary measures, in particular the provisions of Article XX(b)(1);

 

(footnote original) 1 In this Agreement, reference to Article XX(b) includes also the chapeau of that Article.

   Hereby agree as follows:


B. Interpretation and Application of the Preamble

1. First recital: consistency of Members’ SPS measures with obligations within the SPS Agreement

1.   In US/Canada — Continued Suspension, the Appellate Body referring to the first recital of the preamble of the SPS Agreement, recalled the right of WTO Members to take measures to protect human, animal or plant life or health provided that the measures exercised are consistent with the series of obligations that are set forth in the Agreement, “which seek to ensure that the measures are properly justified(1)”.(2)

2. Fifth and sixth recitals: “international standards, guidelines and recommendations”

(a) General

2.   The Codex Alimentarius Commission, the World Organization for Animal Health (previously the International Office of Epizootics), and the Secretariat of the International Plant Protection Convention regularly provide the SPS Committee with information regarding international standards they have adopted.(3)

(b) Relevance of international standards in the SPS Agreement

(i) General

3.   In US/Canada — Continued Suspension, the Appellate Body took note of the SPS Agreement preamble mentioning harmonization of international standards, as one purpose of the agreement. The Appellate Body stated that international standards are given a prominent role under the SPS Agreement particularly in furthering the objective of promoting the harmonization of sanitary and phytosanitary standards between WTO Members. This is to be achieved by encouraging WTO Members to base their SPS measures on international standards, guidelines or recommendations where they exist.(4)

4.   The Appellate Body also recognized this role of the SPS Agreement in EC — Hormones.

“As the preamble of the SPS Agreement recognizes, one of the primary objectives of the SPS Agreement is to ‘further the use of harmonized sanitary and phytosanitary measures between Members, on the basis of international standards, guidelines and recommendations developed by the relevant international organizations’.”(5)

3. The relationship between the SPS Agreement and Article XX(b) of GATT 1994

5.   In EC — Hormones (Canada), the Panel discussed the relationship between the SPS Agreement and Article XX(b) of the GATT 1994. The Panel acknowledged that some provisions of the SPS Agreement, such as the eighth recital of the preamble, elaborate on provisions already contained in the SPS Agreement. However, the Panel noted that this was not conclusive evidence that the SPS Agreement only applies, as Article XX(b) of the GATT 1994 does, if a prior violation of a GATT provision has been established. The Panel found that many provisions of the SPS Agreement, such as those contained in the second and sixth recitals of the preamble, go beyond and are additional to the requirements for the invocation of Article XX(b). The Panel concluded that, while Article XX(b) provides for a general exception which can be invoked to justify a violation of another GATT provision, the SPS Agreement, in contrast, provides for specific obligations to be met for a Member to enact or maintain SPS measures:

“[W]e find the EC claim that the SPS Agreement does not impose ‘substantive’ obligations additional to those already contained in Article XX(b) of GATT not to be persuasive. It is clear that some provisions of the SPS Agreement elaborate on provisions already contained in GATT, in particular Article XX(b). The final preambular paragraph of the SPS Agreement provides, indeed, that the Members desired ‘to elaborate rules for the application of the provisions of GATT 1994 which relate to the use of sanitary or phytosanitary measures, in particular the provisions of Article XX(b)’. Examples of such rules are, arguably, some of the obligations contained in Article 2 of the SPS Agreement. However, on this basis alone we cannot conclude that the SPS Agreement only applies, as Article XX(b) of GATT does, if, and only if, a prior violation of a GATT provision has been established. Many provisions of the SPS Agreement impose ‘substantive’ obligations which go significantly beyond and are additional to the requirements for invocation of Article XX(b).(6) These obligations are, inter alia, imposed to ‘further the use of harmonized sanitary and phytosanitary measures between Members’(7) and to ‘improve the human health, animal health and phytosanitary situation in all Members’.(8) They are not imposed, as is the case of the obligations imposed by Article XX(b) of GATT, to justify a violation of another GATT obligation (such as a violation of the non-discrimination obligations of Articles I or III).

 

We note in this respect that the general approach adopted in Article XX(b) of GATT is fundamentally different from the approach adopted in the SPS Agreement. Article XX(b), which is not limited to sanitary or phytosanitary measures, provides for a general exception which can be invoked to justify any violation of another GATT provision. The SPS Agreement, on the other hand, provides for specific obligations to be met in order for a Member to enact or maintain specific types of measures, namely sanitary and phytosanitary measures.”(9)

4. The precautionary principle

(a) Status in international law

6.   With respect to the “precautionary principle” invoked by the European Communities in support of its claim in EC — Hormones that it had complied with Article 5.1 of the SPS Agreement, the Appellate Body declined to take a position on the status of the precautionary principle in international law:

“The status of the precautionary principle in international law continues to be the subject of debate among academics, law practitioners, regulators and judges. The precautionary principle is regarded by some as having crystallized into a general principle of customary international environmental law. Whether it has been widely accepted by Members as a principle of general or customary international law appears less than clear. We consider, however, that it is unnecessary, and probably imprudent, for the Appellate Body in this appeal to take a position on this important, but abstract, question. We note that the Panel itself did not make any definitive finding with regard to the status of the precautionary principle in international law and that the precautionary principle, at least outside the field of international environmental law, still awaits authoritative formulation.”(10)

7.   The Panel in EC — Approval and Marketing of Biotech Products reviewed the jurisprudence and doctrine related to the precautionary principle, noting many uncertainties in the status of the principle. The Panel finally declined to uphold the European Communities’ contention that the precautionary principle has “by now become a fully-fledged and general principle of international law”, and opted to refrain from expressing any view on the issue.(11)

(b) Relationship of the precautionary principle with the SPS Agreement

8.   As regards the relationship of the “precautionary principle” with the SPS Agreement, the Appellate Body noted the following four elements, one of which concerning the Preamble to the SPS Agreement:

“First, the principle has not been written into the SPS Agreement as a ground for justifying SPS measures that are otherwise inconsistent with the obligations of Members set out in particular provisions of that Agreement … It is reflected also in the sixth paragraph of the preamble … These explicitly recognize the right of Members to establish their own appropriate level of sanitary protection, which level may be higher (i.e., more cautious) than that implied in existing international standards, guidelines and recommendations … Lastly, however, the precautionary principle does not, by itself, and without a clear textual directive to that effect, relieve a Panel from the duty of applying the normal (i.e. customary international law) principles of treaty interpretation in reading the provisions of the SPS Agreement”.”(12)

 

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II. Article 1  

A. Text of Article 1

Article 1: General Provisions

1.   This Agreement applies to all sanitary and phytosanitary measures which may, directly or indirectly, affect international trade. Such measures shall be developed and applied in accordance with the provisions of this Agreement.

 

2.   For the purposes of this Agreement, the definitions provided in Annex A shall apply.

 

3.   The annexes are an integral part of this Agreement.

 

4.   Nothing in this Agreement shall affect the rights of Members under the Agreement on Technical Barriers to Trade with respect to measures not within the scope of this Agreement.


B. Interpretation and Application of Article 1

1. Article 1.1

(a) Scope of the SPS Agreement

(i) Application ratione materiae of the SPS Agreement

9.   The Panel in EC — Hormones identified two requirements that must be met for a measure to fall within the realm of the SPS Agreement:

“According to Article 1.1 of the SPS Agreement, two requirements need to be fulfilled for the SPS Agreement to apply: (i) the measure in dispute is a sanitary or phytosanitary measure; and (ii) the measure in dispute may, directly or indirectly, affect international trade.”(13)

Sanitary or phytosanitary measures

10.   In EC — Hormones (Canada), the Panel reviewed the test applied by the parties to establish whether the measures at issue were sanitary measures. In accordance with the parties analysis, the Panel based its review on the definitions provided in Annex A of the SPS Agreement:

“With respect to the SPS Agreement, both parties agree that the EC measures in dispute are sanitary measures in the sense of Paragraph 1(b) of Annex A of the SPS Agreement. Paragraph 1(b) of Annex A defines a sanitary measure as

 

‘any measure applied to protect human or animal life or health within the territory of the Member from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs’.

 

Footnote 4 to Annex A specifies that ‘contaminants’ include, for the purposes of Annex A, ‘pesticide and veterinary drug residues and extraneous matter’. Since the six hormones in dispute are veterinary drugs, the parties agree that the alleged risks at issue arise from contaminants. We agree with the parties that the EC measures in dispute are ‘applied to protect human … life or health’ within the territory of the European Communities from risks arising from ‘contaminants’, namely residues of six specific hormones, in foods (according to paragraph 1(b) of Annex A). That the contested EC measures are, inter alia, ‘applied to protect human … life or health’ can be inferred from the preambles to, and legislative history of, Directives 81/602/EEC and 88/146/EEC. Since both parties agree that the contested EC measures are ‘sanitary measures’, we see no need to further examine in this dispute the definition of measures ‘applied to protect human … life or health’.”(14)

Measures which may directly or indirectly affect international trade

11.   In EC — Hormones (Canada), the Panel agreed with the parties’ argument that the measures at issue could be considered as SPS measures if they satisfy the other requirement of Article 1.1 namely if they directly or indirectly impact international trade:

“Both parties … agree that, according to Article 1.1 of the SPS Agreement, the SPS Agreement is applicable to this dispute. Article 1.1 provides that the SPS Agreement

 

‘applies to all sanitary and phytosanitary measures which may, directly or indirectly, affect international trade’.

 

We agree with the parties that the EC measures ‘may, directly or indirectly, affect international trade’. It cannot be contested that an import ban affects international trade.”(15)

12.   In EC — Approval and Marketing of Biotech Products, the Panel noted that this second requirement under Article 1 could be lessened given the wording used in the Article:

Article 1.1 of the SPS Agreement provides, inter alia, that the SPS Agreement ‘applies to all [SPS] measures which may, directly or indirectly, affect international trade’. Thus, for an SPS measure to be subject to the disciplines of the SPS Agreement, it must be capable of affecting international trade. …

 

In our view, it is not necessary to demonstrate that an SPS measure has an actual effect on trade. Article 1.1 merely requires that an SPS measure ‘may, directly or indirectly, affect international trade’.”(16)

13.   The Panel in US — Poultry (China) however emphasized the importance of this second requirement, noting that: “Even if a measure falls within the definition of an SPS measure in Annex A(1) of the SPS Agreement, further to Article 1.1 of the SPS Agreement, such measure still needs to be a measure that directly or indirectly affect[s] international trade to be covered by the disciplines of the SPS Agreement.”(17)

(ii) Temporal scope of the SPS Agreement

14.   In EC — Hormones, in discussing the applicability of the SPS Agreement to a measure which was enacted before the entry into force of the Agreement, the Appellate Body held that the SPS Agreement would apply to situations or measures that had not ceased to exist, unless the SPS Agreement revealed a contrary intention. Furthermore, the Appellate Body noted that certain measures of the SPS Agreement “expressly contemplate applicability to SPS measures that already existed on 1 January 1995”:

“We addressed the issue of temporal application in our Report in Brazil — Measures Affecting Desiccated Coconut and concluded on the basis of Article 28 of the Vienna Convention that:

 

Absent a contrary intention, a treaty cannot apply to acts or facts which took place, or situations which ceased to exist, before the date of its entry into force.

 

We agree with the Panel that the SPS Agreement would apply to situations or measures that did not cease to exist, such as the 1981 and 1988 Directives, unless the SPS Agreement reveals a contrary intention. We also agree with the Panel that the SPS Agreement does not reveal such an intention. The SPS Agreement does not contain any provision limiting the temporal application of the SPS Agreement, or of any provision thereof, to SPS measures adopted after 1 January 1995. In the absence of such a provision, it cannot be assumed that central provisions of the SPS Agreement, such as Articles 5.1 and 5.5, do not apply to measures which were enacted before 1995 but which continue to be in force thereafter. If the negotiators had wanted to exempt the very large group of SPS measures in existence on 1 January 1995 from the disciplines of provisions as important as Articles 5.1 and 5.5, it appears reasonable to us to expect that they would have said so explicitly. Articles 5.1 and 5.5 do not distinguish between SPS measures adopted before 1 January 1995 and measures adopted since; the relevant implication is that they are intended to be applicable to both. Furthermore, other provisions of the SPS Agreement, such as Articles 2.2, 2.3, 3.3 and 5.6, expressly contemplate applicability to SPS measures that already existed on 1 January 1995.”(18)

(iii) Shall be developed and applied in accordance with the provisions of this Agreement: relevance of the purpose of the measure at issue

15.   The Panel in EC — Approval and Marketing of Biotech Products stressed the relevance of the purpose of the measure at issue in the establishment of its consistency with the SPS Agreement:

“Having determined that the purpose of Directives 90/220 and 2001/18 is to protect human health and the environment from adverse effects on human health and the environment which might result from the deliberate release of GMOs into the environment, we now proceed to examine whether that purpose is covered by the various sub-paragraphs of Annex A(1) to the SPS Agreement.

We note that in accordance with Annex A(1)(a) and (b) of the SPS Agreement, the SPS Agreement covers measures applied to protect animal and plant life or health from certain risks. Thus, to the extent Directives 90/220 and 2001/18 are applied to protect animals and plants as part of their purpose of protecting the environment, they are not a priori excluded from the scope of application of the SPS Agreement.

It is clear from the definition contained in Annex A(1) that one of the elements which determine whether a particular measure is an SPS measure is the purpose of the measure. A measure is an SPS measure if it is applied “to protect” life or health from certain enumerated risks, or if it is applied ‘to prevent or limit’ certain other damage.”(19)

(iv) Private Standards

16.   The SPS Committee has been discussing the issue of SPS-related private standards since June 2005. The SPS Committee decided in October 2008 to request an ad hoc working group to undertake a three-step study, and present a report proposing concrete actions for consideration by the Committee at the end of this process.(20)

17.   The ad hoc working group on SPS-related private standards completed its work on identifying “Possible Actions for the SPS Committee Regarding SPS-Related Private Standards”, and presented its report to the SPS Committee. The report of the working group is contained in document G/SPS/W/256.

18.   At its meeting of 30–31 March 2011, the Committee adopted five of the six actions put forward by the working group for endorsement.(21) The five actions are listed below:

Action 1: The SPS Committee should develop a working definition of SPS-related private standards and limit any discussions to these.

 

Action 2: The SPS Committee should regularly inform the Codex, OIE and IPPC regarding relevant developments in its consideration of SPS-related private standards, and should invite these organizations to likewise regularly inform the SPS Committee of relevant developments in their respective bodies.

 

Action 3: The SPS Committee invites the Secretariat to inform the Committee on developments in other WTO fora which could be of relevance for its discussions on SPS-related private standards.

 

Action 4: Members are encouraged to communicate with entities involved in SPS-related private standards in their territories to sensitize them to the issues raised in the SPS Committee and underline the importance of international standards established by the Codex, OIE and IPPC.

 

Action 5: The SPS Committee should explore the possibility of working with the Codex, OIE and IPPC to support the development and/or dissemination of informative materials underlining the importance of international SPS standards.(22)

19.   As regards the interpretation of Annex A, see the Section of this Chapter on Annex A.

 

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III. Article 2  

A. Text of Article 2

Article 2: Basic Rights and Obligations

1.   Members have the right to take sanitary and phytosanitary measures necessary for the protection of human, animal or plant life or health, provided that such measures are not inconsistent with the provisions of this Agreement.

 

2.   Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence, except as provided for in paragraph 7 of Article 5.

 

3.   Members shall ensure that their sanitary and phytosanitary measures do not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail, including between their own territory and that of other Members. Sanitary and phytosanitary measures shall not be applied in a manner which would constitute a disguised restriction on international trade.

 

4.   Sanitary or phytosanitary measures which conform to the relevant provisions of this Agreement shall be presumed to be in accordance with the obligations of the Members under the provisions of GATT 1994 which relate to the use of sanitary or phytosanitary measures, in particular the provisions of Article XX(b).


B. Interpretation and Application of Article 2

1. Scope of Article 2 obligations

20.   According to the Panel in US — Poultry (China), the “overarching and encompassing” title of Article 2 being “Basic Rights and Obligations”, leads to the conclusion that the obligations in Article 2 inform all of the SPS Agreement.(23)

2. Article 2.2

(a) The elements of Article 2.2

21.   In EC — Approval and Marketing of Biotech Products, the Panel listed the requirements within Article 2.2 of the SPS Agreement:

“It is apparent from the text of Article 2.2 that this provision contains three separate requirements: (i) the requirement that SPS measures be applied only to the extent necessary to protect human, animal or plant life or health; (ii) the requirement that SPS measures be based on scientific principles; and (iii) the requirement that SPS measures not be maintained without sufficient scientific evidence.”(24)

(b) The requirement that SPS measures not be maintained without sufficient scientific evidence

(i) General

22.   The Panel in US — Poultry (China) was of the view that to maintain a measure with sufficient scientific evidence, the scientific evidence must bear a rational relationship to the measure, be sufficient to demonstrate the extent of the risk which the measure is supposed to address, and be of the kind necessary for a risk assessment.(25)

23.   In EC — Hormones, as part of its determination of the link between the precautionary principle and the SPS Agreement, the Appellate Body noted that a Member’s precautionary approach is one element that a panel should bear in mind when appraising the scientific basis underlying their SPS measures:

“[A] Panel charged with determining, for instance, whether ‘sufficient scientific evidence’ exists to warrant the maintenance by a Member of a particular SPS measure may, of course, and should, bear in mind that responsible, representative governments commonly act from perspectives of prudence and precaution where risks of irreversible, e.g. life terminating, damage to human health are concerned.”(26)

(ii) Rationale for the requirement of sufficient evidence

24.   In EC — Hormones, the Appellate Body considered the purpose of the requirement of “sufficient scientific evidence”, which with other provisions of the SPS Agreement enables the balance between promotion of international trade and protection of human life and health within the Agreement:

“The requirements of a risk assessment under Article 5.1, as well as of “sufficient scientific evidence” under Article 2.2, are essential for the maintenance of the delicate and carefully negotiated balance in the SPS Agreement between the shared, but sometimes competing, interests of promoting international trade and of protecting the life and health of human beings.”(27):

(iii) Sufficient

Meaning

25.   In Japan — Agricultural Products II, with respect to the term “sufficient” in Article 2.2, the Appellate Body required an adequate relationship between the SPS measure and the scientific evidence:

“The ordinary meaning of ‘sufficient’ is ‘of a quantity, extent, or scope adequate to a certain purpose or object’. From this, we can conclude that ‘sufficiency’ is a relational concept. ‘Sufficiency’ requires the existence of a sufficient or adequate relationship between two elements, in casu, between the SPS measure and the scientific evidence”.(28)

26.   In Japan — Apples (Article 21.5 — US), the Panel found (para. 8.45) that for scientific evidence to support a measure sufficiently it must also demonstrate the existence of the risk which the measure is supposed to address:

“[I]n order for scientific evidence to support a measure sufficiently, it seems logical to us that such scientific evidence must also be sufficient to demonstrate the existence of the risk which the measure is supposed to address. As a result, it seems reasonable to consider the extent of the relationship between the scientific evidence and the risk which this evidence is claimed to establish.”

Context

27.   The Appellate Body in Japan — Agricultural Products II stated that “[t]he context of the word ‘sufficient’ or, more generally, the phrase ‘maintained without sufficient scientific evidence’ in Article 2.2, includes Article 5.1 as well as Articles 3.3 and 5.7 of the SPS Agreement”.(29)

Insufficiency threshold

28.   After an examination of the context of the term “sufficient”, the Appellate Body in Japan — Agricultural Products II disagreed with Japan on the notion of a standard of “patent insufficiency”:

“We do not agree with Japan’s proposition that direct application of Article 2.2 of the SPS Agreement should be limited to situations in which the scientific evidence is ‘patently’ insufficient, and that the issue raised in this dispute should have been dealt with under Article 5.1 of the SPS Agreement. There is nothing in the text of either Articles 2.2 or 5.1, or any other provision of the SPS Agreement, that requires or sanctions such limitation of the scope of Article 2.2.”(30)

(iv) Scientific evidence

29.   The Panel in Japan — Apples looked into the meaning of “scientific evidence” and discussed the significance of the nature of the evidence that ought to be considered when a Member is making a determination of what measure to put in place.

“We consider that … we must give full meaning to the term ‘scientific’ and conclude that, in the context of Article 2.2, the evidence to be considered should be evidence gathered through scientific methods, excluding by the same token information not acquired through a scientific method. We further note that scientific evidence may include evidence that a particular risk may occur … as well as evidence that a particular requirement may reduce or eliminate that risk ….

 

Likewise, the use of the term ‘evidence’ must also be given full significance. Negotiators could have used the term ‘information’, as in Article 5.7, if they considered that any material could be used. By using the term ‘scientific evidence’, Article 2.2 excludes in essence not only insufficiently substantiated information, but also such things as a non-demonstrated hypothesis.

[R]equiring ‘scientific evidence’ does not limit the field of scientific evidence available to Members to support their measures. ‘Direct’ or ‘indirect’ evidence may be equally considered. The only difference is not one of scientific quality, but one of probative value within the legal meaning of the term, since it is obvious that evidence which does not directly prove a fact might not have as much weight as evidence directly proving it, if it is available.”(31)

(v) A rational and objective relationship between the SPS measure and the scientific evidence

30.   The Appellate Body in Japan — Agricultural Products II established that Article 2.2 requires a rational or objective relationship between the SPS measure and the scientific evidence, a relationship that is to be determined on a case-by-case basis:

“[W]e agree with the Panel that the obligation in Article 2.2 that an SPS measure not be maintained without sufficient scientific evidence requires that there be a rational or objective relationship between the SPS measure and the scientific evidence. Whether there is a rational relationship between an SPS measure and the scientific evidence is to be determined on a case-by-case basis and will depend upon the particular circumstances of the case, including the characteristics of the measure at issue and the quality and quantity of the scientific evidence.”(32)

31.   In a finding upheld by the Appellate Body, the Panel, in Japan — Apples, considered that all the individual requirements contained in the measure should be treated cumulatively as the phytosanitary measure at issue in the case. On this basis, the Panel held that a measure as a whole should be considered to be maintained ‘without sufficient scientific evidence’ if one or more of its elements are not justified by the relevant scientific evidence addressing the risk at issue.(33)

(c) Burden of proof on sufficiency of the evidence

(i) General rule on allocation of burden of proof

32.   In Japan — Agricultural Products II, the Appellate Body emphasized that in proceedings under the SPS Agreement, the general rules on burden of proof which were outlined in EC — Hormones need to be followed:

“With regard to the rules on burden of proof in proceedings under the SPS Agreement, we noted in our Report in European Communities — Hormones, that the Panel in that case appropriately described the issue of the burden of proof as one of particular importance, in view of the multiple and complex issues of fact which may arise in disputes under that Agreement.(34) Furthermore, as we noted in European Communities — Hormones, the rules on burden of proof are rules ‘applicable in any adversarial proceedings’.(35) We, therefore, agreed with the Panel in that case that in proceedings under the SPS Agreement:

 

The initial burden lies on the complaining party, which must establish a prima facie case of inconsistency with a particular provision of the SPS Agreement on the part of the defending party, or more precisely, of its SPS measure or measures complained about. When that prima facie case is made, the burden of proof moves to the defending party, which must in turn counter or refute the claimed inconsistency.”(36)

33.   On the allocation of burden of proof, the Appellate Body in Japan — Apples said that although the complaining party bears the burden of proving its case, the responding party is responsible for proving the case it seeks to make in response:

“In this case, the United States seeks a finding that Japan’s measure is inconsistent with Article 2.2 of the SPS Agreement. Therefore, the initial burden lies with the United States to establish a prima facie case that the measure is inconsistent with Article 2.2… . Following the Appellate Body’s ruling in EC — Hormones, if this prima facie case is made, it would be for Japan to counter or refute the claim that the measure is ‘maintained without sufficient scientific evidence’.

 

That said, the Appellate Body’s statement in EC — Hormones does not imply that the complaining party is responsible for providing proof of all facts raised in relation to the issue of determining whether a measure is consistent with a given provision of a covered agreement. In other words, although the complaining party bears the burden of proving its case, the responding party must prove the case it seeks to make in response. In US — Wool Shirts and Blouses, the Appellate Body stated

 

‘… the party who asserts a fact, whether the claimant or the respondent, is responsible for providing proof thereof.(37)(38)

(ii) Presumption of no relevant studies or report

34.   The Panel in Japan — Agricultural Products II had limited its finding of violation of Article 2.2 to only four of the eight products at issue on the grounds that in respect of the other four products, the United States had not adduced sufficient evidence to raise a prima facie case.(39) The Appellate Body agreed with the Panel and found that it would be sufficient for the complainant to raise a presumption that no relevant scientific studies or reports exist:

“[W]e disagree with the United States that the Panel imposed on the United States an impossible and, therefore, erroneous burden of proof by requiring it to prove a negative, namely, that there are no relevant studies and reports which support Japan’s varietal testing requirement. In our view, it would have been sufficient for the United States to raise a presumption that there are no relevant studies or reports. Raising a presumption that there are no relevant studies or reports is not an impossible burden. The United States could have requested Japan, pursuant to Article 5.8 of the SPS Agreement, to provide ‘an explanation of the reasons’ for its varietal testing requirement, in particular, as it applies to apricots, pears, plums and quince. Japan would, in that case, be obliged to provide such explanation. The failure of Japan to bring forward scientific studies or reports in support of its varietal testing requirement as it applies to apricots, pears, plums and quince, would have been a strong indication that there are no such studies or reports. The United States could also have asked the Panel’s experts specific questions as to the existence of relevant scientific studies or reports or it could have submitted to the Panel the opinion of experts consulted by it on this issue. The United States, however, did not submit any evidence relating to apricots, pears, plums and quince.”(40)

(iii) Burden of proof determined by scope of claim

35.   Regarding the concept of prima facie, the Appellate Body in Japan — Apples agreed with the Panel that the complainant could establish a prima facie case of inconsistency with Article 2.2 of the SPS Agreement even though it had confined its arguments to the perceived risks underlying the measures within the scope of its claim(41):

“Japan … submits that, ‘in order to establish a prima facie case of insufficient scientific evidence under Article 2.2 of the SPS Agreement, the complaining party must establish that there is not sufficient evidence for any of the perceived risks underlying the measure.’ … We find no basis for the approach advocated by Japan. … In the present case, the Panel appears to have concluded that in order to demonstrate a prima facie case that Japan’s measure is maintained without sufficient scientific evidence, it sufficed for the United States to address only the question of whether mature, symptomless apples could serve as a pathway for fire blight.

 

The Panel’s conclusion seems appropriate to us for the following reasons. First, the claim pursued by the United States was that Japan’s measure is maintained without sufficient scientific evidence to the extent that it applies to mature, symptomless apples exported from the United States to Japan. What is required to demonstrate a prima facie case is necessarily influenced by the nature and the scope of the claim pursued by the complainant. A complainant should not be required to prove a claim it does not seek to make. Secondly, the Panel found that mature, symptomless apple fruit is the commodity ‘normally exported’ by the United States to Japan. The Panel indicated that the risk that apples fruit other than mature, symptomless apples may actually be imported into Japan would seem to arise primarily as a result of human or technical error, or illegal actions, and noted that the experts characterized errors of handling and illegal actions as ‘small’ or ‘debatable’ risks. Given the characterization of these risks, in our opinion it was legitimate for the Panel to consider that the United States could demonstrate a prima facie case of inconsistency with Article 2.2 of the SPS Agreement through argument based solely on mature, symptomless apples. Thirdly, the record contains no evidence to suggest that apples other than mature, symptomless ones have ever been exported to Japan from the United States as a result of errors of handling or illegal actions… .”(42)

(iv) Burden of proof for both Articles 2.2 and 5.7

36.   In EC — Approval and Marketing of Biotech Products, the Panel in accordance with the Panel’s findings in Japan — Agricultural Products II(43), made it clear that the burden of proof under Article 2.2 needs to be allocated in consideration of provisions under Article 5.7 of the SPS Agreement given its conclusion that Article 5.7 is a qualified right and not an exception to Article 2.2:

“According to the Appellate Body’s statement in EC — Tariff Preferences, in cases where the permissive provision constitutes a right rather than an exception, ‘the complaining party bears the burden of establishing that a challenged measure is inconsistent with the provision permitting particular behaviour’.(44) And in EC — Sardines, the Appellate Body observed that ‘[i]n EC — Hormones, we found that a ‘general rule–exception’ relationship between Articles 3.1 and 3.3 of the SPS Agreement does not exist, with the consequence that the complainant had to establish a case of inconsistency with both Articles 3.1 and 3.3’.(45) We deduce from these two statements that in cases where a complaining party alleges that an SPS measure is inconsistent with the obligation in Article 2.2 not to maintain SPS measures without sufficient scientific evidence, it is incumbent on the complaining party, and not the responding party, to demonstrate that the challenged SPS measure is inconsistent with at least one of the four requirements set forth in Article 5.7. If such non-compliance is demonstrated, then, and only then, does the relevant obligation in Article 2.2 apply to the challenged SPS measure.”(46)

(d) Standard of review of a panel with respect to sufficiency of scientific evidence

(i) Panel to take into account the prudence commonly exercised by governments

37.   In EC — Hormones, the Appellate Body, while addressing the relationship between the precautionary principle and the SPS Agreement in the context of its analysis of whether a measure was maintained without sufficient scientific evidence, noted that a panel should take into account in its examination the prudence commonly exercised by governments in the event of irreversible risks:

“[A] Panel charged with determining, for instance, whether ‘sufficient scientific evidence’ exists to warrant the maintenance by a Member of a particular SPS measure may, of course, and should, bear in mind that responsible, representative governments commonly act from perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to human health are concerned.”(47)

(ii) Panel not to conduct own risk assessment

38.   The Panel in Japan — Agricultural Products II emphasized that in reviewing whether the measure at issue was being maintained without sufficient scientific evidence, it would not conduct its own risk assessment:

“To determine whether or not the varietal testing requirement is maintained without sufficient scientific evidence … we need to refer to the opinions we received from the experts advising the Panel. We recall that these expert opinions are opinions on the evidence submitted by the parties. We are not empowered, nor are the experts advising the Panel, to conduct our own risk assessment.”(48)

(iii) Panel to assess relevant allegations of fact

39.   The Appellate Body in Japan — Apples also found that the Panel acted within the limits of its investigative authority when the Panel assessed relevant allegations of fact asserted by Japan as the respondent:

“Japan also contends that the Panel did not have the authority to make certain findings of fact and, in support of this contention, refers to the Appellate Body’s statement in Japan — Agricultural Products II:

 

Article 13 of the DSU and Article 11.2 of the SPS Agreement suggest that Panels have a significant investigative authority. However, this authority cannot be used by a Panel to rule in favour of a complaining party which has not established a prima facie case of inconsistency based on specific legal claims asserted by it.’(49)

 

We disagree with Japan. We note first that we are not persuaded that the findings of the Panel, identified by Japan in relation to this argument, relate specifically to, or address apples other than mature, symptomless apples, as Japan seems to assume. Also, the Appellate Body’s finding in Japan — Agricultural Products II does not support Japan’s argument that the Panel was barred from making findings of fact in connection with apples other than mature, symptomless apples. Those findings were relevant to the claim pursued by the United States under Article 2.2 of the SPS Agreement, and were responsive to relevant allegations of fact advanced by Japan in the context of its rebuttal of the United States’ claim. The Panel acted within the limits of its investigative authority because it did nothing more than assess relevant allegations of fact asserted by Japan, in the light of the evidence submitted by the parties and the opinions of the experts.”(50)

(iv) Panel to take into account views of experts while evaluating scientific evidence

40.   The Appellate Body in Japan — Apples held that the Panel was entitled to take into account the views of the experts in assessing whether the United States had established a prima facie case, recalling the similar approaches taken in other cases involving the evaluation of scientific evidence:

“In order to assess whether the United States had established a prima facie case, the Panel was entitled to take into account the view of the experts. Indeed, in India — Quantitative Restrictions, the Appellate Body indicated that it may be useful for a Panel to consider the views of the experts it consults in order to determine whether a prima facie case has been made.(51) Moreover, on several occasions, including disputes involving the evaluation of scientific evidence, the Appellate Body has stated that Panels enjoy discretion as the trier of facts(52); they enjoy ‘a margin of discretion in assessing the value of the evidence, and the weight to be ascribed to that evidence.’(53) Requiring Panels, in their assessment of the evidence before them, to give precedence to the importing Member’s evaluation of scientific evidence and risk is not compatible with this well-established principle.”(54)

(v) Panel not obliged to give precedence to importing Members approach to scientific evidence and risk

41.   The Appellate Body in Japan — Apples held that a panel is not obliged to give precedence to the importing Member’s approach to scientific evidence and riskover the views of the experts when analyzing and assessing scientific evidence to determine whether a complainant established a prima facie case under Article 2.2. The obligation is to carry out an objective assessment of facts.(55)

(e) Relationship with other Articles

(i) Article 1.1

42.   As regards applicability of the SPS Agreement to measures adopted before 1 January 1995 and measures adopted since, see paragraph 14 above.

(ii) Article 4

43.   The Panel in Japan — Apples rejected Japan’s argument that the Panel should consider Article 4 of the SPS Agreement in its assessment of Article 2.2:

“[W]e agree that other provisions of the SPS Agreement are part of the context of Article 2.2, as recalled by the Appellate Body in Japan — Agricultural Products II(56). Article 4 deals with the specific question of the recognition of equivalence of measures. Unlike Articles 3.3, 5.1 and 5.7, the purpose of Article 4 is clearly different from that of Article 2.2. We also note that the United States did not raise any claim under Article 4 and that this Article is not a defence against violations of other provisions of the SPS Agreement. As a result, we see no other reason to consider Japan’s arguments regarding Article 4 in our assessment of Article 2.2, other than to the extent that Article 4 might form part of the relevant context in the interpretation of Article 2.2.”(57)

(iii) Article 5

Article 5.1

44.   In EC — Hormones, the Appellate Body stated that Articles 2.2 and 5.1 should “constantly be read together”

“[T]he Panel considered that Article 5.1 may be viewed as a specific application of the basic obligations contained in Article 2.2 of the SPS Agreement

 

We agree with this general consideration and would also stress that Articles 2.2 and 5.1 should constantly be read together. Article 2.2 informs Article 5.1: the elements that define the basic obligation set out in Article 2.2 impart meaning to Article 5.1.”(58)

45.   In Australia — Salmon, the Appellate Body agreed with the Panel(59) that in the event an SPS measure is not based on a risk assessment, as required in Article 5.1, this measure can be presumed, more generally, not to be based on scientific principles or not to be maintained without sufficient scientific evidence within the meaning of Article 2.2. On that basis, the Appellate Body concluded that a violation of Article 5.1 also implied an inconsistency with Article 2.2.(60)

46.   In EC — Approval and Marketing of Biotech Products, the Panel discussed the relationship between Article 2.2 and Article 5.1 of the SPS Agreement, noting that the complainants’ claim under Article 2.2 in that case was in the nature of a consequential claim:

“The Panel notes that the Complaining Parties’ claim under Article 2.2 is in the nature of a consequential claim. The Complaining Parties submit that an inconsistency with Article 2.2 follows by implication from a demonstrated inconsistency with Article 5.1. However, we have determined above that Article 5.1 is not applicable to the product-specific measures as defined by the Complaining Parties and that, consequently, the European Communities has not acted inconsistently with its obligations under Article 5.1 in respect of the relevant product-specific measures. Since the European Communities has not acted inconsistently with Article 5.1, and since the Complaining Parties’ claim under Article 2.2 is premised on the existence of a breach of Article 5.1 by the European Communities, the Complaining Parties’ claim under Article 2.2 in our view cannot succeed.”(61)

47.   For the order of analysis, refer to paragraph 189 below.

Articles 5.1 and 5.2

48.   In Australia — Apples, the Panel recognized that in past disputes, panels and the Appellate Body have emphasized the relationship between Articles 2.2, 5.1 and 5.2. However, the Panel was quick to point out that the close link between the three provisions does not mean that they are identical provisions, as this would render at least one of the provisions redundant:

“The close link between Articles 2.2, 5.1 and 5.2 of the SPS Agreement does not mean that these are identical provisions. Otherwise at least one of the provisions would be redundant. The Panel is aware in this respect that, as noted by the Appellate Body in US — Gasoline, under the general rule of interpretation contained in the Vienna Convention on the Law of Treaties, ‘interpretation must give meaning and effect to all the terms of a treaty’ and ‘[a]n interpreter is not free to adopt a reading that would result in reducing whole clauses or paragraphs of a treaty to redundancy or inutility.’(62) With respect to the specific obligation that SPS measures are based on scientific principles, Article 2.2 directly focuses on the necessary link that must exist between the SPS measure and the scientific principles and evidence. Under Articles 5.1 and 5.2 of the SPS Agreement, such link is still necessary, but it is indirect as it rests on the requirement for a risk assessment. Any SPS measure must be based on a risk assessment, which, in turn, must be based on scientific evidence.”(63)

49.   The Panel in US — Poultry (China) agreed with the Panel’s statements in Australia — Apples and clarified that “where a measure is not based on a risk assessment as required in Articles 5.1 and 5.2 of the SPS Agreement, this measure is presumed not to be based on scientific principles and to be maintained without sufficient scientific evidence”.(64)

Articles 5.4 and 5.6

50.   On the relationship between Articles 5.4 to 5.6 and Article 2.2, the Panel in EC — Hormones noted:

Articles 5.4 to 5.6 may be viewed as specific applications of the basic obligations provided for in Article 2.2 which, inter alia, states that ‘Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health’ (emphasis added) and Article 2.3 which provides that ‘Members shall ensure that their sanitary and phytosanitary measures do not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail …’ and that ‘Sanitary and phytosanitary measures shall not be applied in a manner which would constitute a disguised restriction on international trade’ (emphasis added).”(65)

51.   The Panel in Japan — Apples emphasized that the requirement not to maintain a measure without sufficient scientific evidence under Article 2.2 should not be confused with the requirement of Article 5.6:

“[W]e should also be careful not to confuse the requirement that a measure is not maintained without sufficient scientific evidence with the requirement of Article 5.6 of the SPS Agreement that the measure is ‘not more trade-restrictive than required to achieve [Japan’s] appropriate level of … phytosanitary protection’. In other words, while we might find that some specific requirements of the measure at issue are not supported by sufficient scientific evidence, our findings should be limited to Article 2.2.”(66)

Article 5.7

52.   The Panel in Japan — Agricultural Products II stated that a measure consistent with Article 5.7 cannot be found inconsistent with Article 2.2:

“[B]efore we can find … whether or not Article 2.2 is violated in this dispute — we recall that Article 2.2 provides that ‘Members shall ensure that any … phytosanitary measure … is not maintained without sufficient scientific evidence, except as provided for in paragraph 7 of Article 5’ (emphasis added). We note that Japan invokes Article 5.7 in support of its varietal testing requirement. We therefore need to examine next whether the varietal testing requirement is a measure meeting the requirements in Article 5.7. If the varietal testing requirement meets these requirements, we cannot find that it violates Article 2.2.”(67)

53.   In Japan — Agricultural Products II, the Appellate Body addressed the relationship between the requirement of sufficient scientific evidence under Article 2.2 and Article 5.7 and considered that Article 5.7 operates as a qualified exemption from the obligation under Article 2.2:

“[I]t is clear that Article 5.7 of the SPS Agreement, to which Article 2.2 explicitly refers, is part of the context of the latter provision and should be considered in the interpretation of the obligation not to maintain an SPS measure without sufficient scientific evidence. Article 5.7 allows Members to adopt provisional SPS measures ‘[i]n cases where relevant scientific evidence is insufficient’ and certain other requirements are fulfilled. Article 5.7 operates as a qualified exemption from the obligation under Article 2.2 not to maintain SPS measures without sufficient scientific evidence. An overly broad and flexible interpretation of that obligation would render Article 5.7 meaningless.”(68)

54.   The Panel in EC — Approval and Marketing of Biotech Products, however, disagreed with the Appellate Body’s characterization of Article 5.7 as a qualified exemption from Article 2.2. Instead, the Panel applied the Appellate Body’s logic in EC — Tariff Preferences and EC — Hormones (where the Appellate Body considered the relationship between Articles 3.1 and 3.3 of the SPS Agreement) and found that Article 5.7 establishes an autonomous right of the importing Member:

“Evaluating the relationship between Article 2.2 and Article 5.7 in the light of the general test provided by the Appellate Body in EC — Tariff Preferences, we consider that the relationship in question is one where ‘one provision [Article 5.7] permits, in certain circumstances, behaviour [namely, the provisional adoption of SPS measures in cases where scientific evidence is insufficient on the basis of available pertinent information] that would otherwise be inconsistent with an obligation in another provision [namely, the obligation in Article 2.2 not to maintain SPS measures without sufficient scientific evidence], [where] one of the two provisions [namely, Article 2.2] refers to the other provision, [and] where one of the provisions [namely, Article 2.2, and in particular the clause “except as provided for in paragraph 7 of Article 5”] suggests that the obligation [in Article 2.2 not to maintain SPS measures without sufficient scientific evidence] is not applicable to measures falling within the scope of Article 5.7’. Thus, we find the general test provided by the Appellate Body in EC — Tariff Preferences to be applicable, and application of that test leads us to the conclusion that Article 5.7 should be characterized as a right and not an exception from a general obligation under Article 2.2. In other words, we consider that in the same way that ‘Article 3.1 of the SPS Agreement […] excludes from its scope of application the kinds of situations covered by Article 3.3 of that Agreement’, Article 2.2 excludes from its scope of application the kinds of situations covered by Article 5.7.”(69)

55.   The Panel in EC — Approval and Marketing of Biotech Products also found that if a challenged SPS measure was adopted and maintained consistently with Article 5.7 then the obligation in Article 2.2 not to maintain SPS measures without sufficient scientific evidence is not applicable:

“In concrete terms, characterizing Article 5.7 as a qualified right rather than an exception means that if a challenged SPS measure was adopted and is maintained consistently with the four cumulative requirements of Article 5.7, the situation is ‘as provided for in paragraph 7 of Article 5’ (Article 2.2), and the obligation in Article 2.2 not to maintain SPS measures without sufficient scientific evidence is not applicable to the challenged measure. Conversely, if a challenged SPS measure is not consistent with one of the four requirements of Article 5.7, the situation is not ‘as provided for in paragraph 7 of Article 5’ (Article 2.2), and the relevant obligation in Article 2.2 is applicable to the challenged measure, provided there are no other elements which render Article 2.2 inapplicable.”(70)

56.   The Panel in EC — Approval and Marketing of Biotech Products rejected an argument put forth by the European Communities that if a Panel found an SPS measure to be inconsistent with Article 5.7 it should find a violation of Article 5.7 alone and not find that the obligations of Article 2.2 are applicable to the measure:

“To say, as the Appellate Body did, that a measure is ‘inconsistent’ with Article 5.7 when the relevant requirements are not satisfied is not tantamount to saying that Article 2.2 is inapplicable to that measure. Indeed, as we have pointed out, the Appellate Body in Japan — Agricultural Products II also stated that Article 5.7 operates as a qualified exemption from the obligation under Article 2.2 not to maintain SPS measures without sufficient scientific evidence. Moreover, the ordinary meaning of the clause ‘except as provided for in paragraph 7 of Article 5’ in Article 2.2 indicates that Article 2.2 would be applicable in a situation where a measure meets some, but not all, of the requirements of Article 5.7.”(71)

Articles 5.1 and 5.7

57.   In US/Canada — Continued Suspension, the Appellate Body addressed the relationship between Articles 2.2, 5.1 and 5.7. The Appellate Body emphasized the requirement common to these articles, that the application of one or another provision depends on the availability of sufficient scientific evidence:

“Under Article 2.2 of the SPS Agreement, WTO Members are required to ‘ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence, except as provided for in paragraph 7 of Article 5.’ This requirement is made operative in other provisions of the SPS Agreement, including Article 5.1, which requires SPS measures to be ‘based on’ a risk assessment. At the same time, Article 2.2 excludes from its scope of application situations in which the relevant scientific evidence is insufficient. In such situations, the applicable provision is Article 5.7 of the SPS Agreement. Thus, the applicability of Articles 2.2 and 5.1, on the one hand, and of Article 5.7, on the other hand, will depend on the sufficiency of the scientific evidence. The Appellate Body has explained that the relevant scientific evidence will be considered ‘insufficient’ for purposes 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.’(72) This means that where the relevant scientific evidence is sufficient to perform a risk assessment, as defined in Annex A of the SPS Agreement, a WTO Member may take an SPS measure only if it is ‘based on’ a risk assessment in accordance with Article 5.1 and that SPS measure is also subject to the obligations in Article 2.2. If the relevant scientific evidence is insufficient to perform a risk assessment, a WTO Member may take a provisional SPS measure on the basis provided in Article 5.7, but that Member must meet the obligations set out in that provision.”(73)

3. Article 2.3

(a) Elements of violation

58.   The Panel in Australia — Salmon (Article 21.5 — Canada) identified three elements necessary to find a violation of the first sentence of Article 2.3:

“[T]hree elements, cumulative in nature, are required for a violation of this provision:

 

(1)   the measure discriminates between the territories of Members other than the Member imposing the measure, or between the territory of the Member imposing the measure and that of another Member;

 

(2)   the discrimination is arbitrary or unjustifiable; and

 

(3)   identical or similar conditions prevail in the territory of the Members compared.”(74)

(b) Scope of discrimination

59.   While the Panel found no violation of Article 2.3 in Australia — Salmon (Article 21.5 — Canada)(75), it also stated that Article 2.3 prohibits not only discrimination between similar products, but also between different products:

“[W]e are of the view that discrimination in the sense of Article 2.3, first sentence, may also include discrimination between different products, e.g. not only discrimination between Canadian salmon and New Zealand salmon, or Canadian salmon and Australian salmon; but also discrimination between Canadian salmon and Australian fish including non-salmonids.”(76)

(c) Relationship with other Articles

(i) Article 1.1

60.   On the applicability of the SPS Agreement to measures adopted before 1 January 1995 and measures adopted since, see paragraph 14 above.

(ii) Article 5.5

61.   In EC — Hormones the Appellate Body noted the close relationship between Articles 2.3 and 5.5:

Article 5.5 must be read in context. An important part of that context is Article 2.3 of the SPS Agreement, … When read together with Article 2.3, Article 5.5 may be seen to be marking out and elaborating a particular route leading to the same destination set out in Article 2.3.”(77)

62.   In the context of examining the European Communities’ measure at issue in the light of Article 5.5, the Appellate Body in EC — Hormones made the following statement with respect to Article 2.3:

“It is well to bear in mind that, after all, the difference in levels of protection that is characterizable as arbitrary or unjustifiable is only an element of (indirect) proof that a Member may actually be applying an SPS measure in a manner that discriminates between Members or constitutes a disguised restriction on international trade, prohibited by the basic obligations set out in Article 2.3 of the SPS Agreement.”(78)

63.   The Panel in Australia — Salmon, in a finding upheld by the Appellate Body(79), held that a violation of Article 5.5 implied a violation of Article 2.3:

“Indeed, even though Article 5.5 deals with arbitrary or unjustifiable distinctions in levels of protection imposed by one WTO Member for different situations and Article 2.3 addresses, rather, sanitary measures which (1) arbitrarily or unjustifiably discriminate between WTO Members or (2) are applied in a manner which would constitute a disguised restriction on trade; the third element under Article 5.5 also requires that the measure in dispute results in discrimination or a disguised restriction on trade. We conclude, therefore, that if we were to find that all three elements under Article 5.5 — including, in particular, the third element — are fulfilled and that, therefore, the more specific Article 5.5 is violated, such finding can be presumed to imply a violation of the more general Article 2.3. We do recognize, at the same time, that, given the more general character of Article 2.3, not all violations of Article 2.3 are covered by Article 5.5.”(80)

64.   In Australia — Salmon, the Appellate Body elaborated on the relationship between Articles 2.3 and 5.5 and considered that a finding of violation of Article 5.5 necessarily implies a violation of Article 2.3:

“We recall that the third — and decisive — element of Article 5.5, discussed above, requires a finding that the SPS measure which embodies arbitrary or unjustifiable restrictions in levels of protection results in ‘discrimination or a disguised restriction on international trade’. Therefore, a finding of violation of Article 5.5 will necessarily imply a violation of Article 2.3, first sentence, or Article 2.3, second sentence. Discrimination ‘between Members, including their own territory and that of others Members’ within the meaning of Article 2.3, first sentence, can be established by following the complex and indirect route worked out and elaborated by Article 5.5. However, it is clear that this route is not the only route leading to a finding that an SPS measure constitutes arbitrary or unjustifiable discrimination according to Article 2.3, first sentence. Arbitrary or unjustifiable discrimination in the sense of Article 2.3, first sentence, can be found to exist without any examination under Article 5.5.”(81)

4. Relationship of Article 2 generally with other Articles

(a) Articles 3 and 5

65.   In EC — Hormones, with respect to the Panel’s decision to examine a claim under Articles 3 and 5 before a claim under Article 2(82), the Appellate Body indicated a preference for beginning the analysis with Article 2:

“We are, of course, surprised by the fact that the Panel did not begin its analysis of this whole case by focusing on Article 2 that is captioned ‘Basic Rights and Obligations’, an approach that appears logically attractive.”(83)

66.   In Australia — Salmon, where Articles 2, 3 and 5 were at issue, the Panel decided to commence its analysis under Article 5, because (1) Canada, the complaining party, focused initially on this provision with respect to its claims and (2) the provisions under Article 5 “provide for more specific and detailed rights and obligations” than Article 2. The Appellate Body did not address this issue:

“[E]ven if we were to start our examination of this dispute under Article 3, we would in any event be referred to and thus still need to address Articles 2 and 5. To conduct our examination of this case in the most efficient manner, we shall, therefore, first address Articles 2 and 5 … Since in this particular case, (1) Canada itself first presents its claims under Article 5, before addressing those under Article 2, and (2) the provisions invoked by Canada under Article 5 (i.e., Articles 5.1, 5.2, 5.5 and 5.6) all provide for more specific and detailed rights and obligations than the ‘Basic Rights and Obligations’ set out in rather broad wording in the provisions invoked by Canada under Article 2 (i.e., Articles 2.2 and 2.3), we consider it more appropriate in the circumstances of this dispute to first deal with Canada’s claims under Article 5.”(84)

(b) Articles 5, 6, 7 and 8

67.   In Japan — Agricultural Products II, where claims were made under Articles 2, 5, 7 and 8, the Panel began its examination with Article 2. The Appellate Body did not address this issue.(85)

 

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IV. Article 3  

A. Text of Article 3

Article 3. Harmonization

1.   To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in this Agreement, and in particular in paragraph 3.

 

2.   Sanitary or phytosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994.

 

3.   Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5.(2) Notwithstanding the above, all measures which result in a level of sanitary or phytosanitary protection different from that which would be achieved by measures based on international standards, guidelines or recommendations shall not be inconsistent with any other provision of this Agreement.

 

(footnote original) 2 For the purposes of paragraph 3 of Article 3, there is a scientific justification if, on the basis of an examination and evaluation of available scientific information in conformity with the relevant provisions of this Agreement, a Member determines that the relevant international standards, guidelines or recommendations are not sufficient to achieve its appropriate level of sanitary or phytosanitary protection.

 

4.   Members shall play a full part, within the limits of their resources, in the relevant international organizations and their subsidiary bodies, in particular the Codex Alimentarius Commission, the International Office of Epizootics, and the international and regional organizations operating within the framework of the International Plant Protection Convention, to promote within these organizations the development and periodic review of standards, guidelines and recommendations with respect to all aspects of sanitary and phytosanitary measures.

 

5.   The Committee on Sanitary and Phytosanitary Measures provided for in paragraphs 1 and 4 of Article 12 (referred to in this Agreement as the “Committee”) shall develop a procedure to monitor the process of international harmonization and coordinate efforts in this regard with the relevant international organizations.


B. Interpretation and Application of Article 3

1. Object and purpose

68.   In EC — Hormones, the Appellate Body held that the object and purpose of Article 3 was to promote the harmonization of national SPS measures:

“In generalized terms, the object and purpose of Article 3 is to promote the harmonization of the SPS measures of Members on as wide a basis as possible, while recognizing and safeguarding, at the same time, the right and duty of Members to protect the life and health of their people. The ultimate goal of the harmonization of SPS measures is to prevent the use of such measures for arbitrary or unjustifiable discrimination between Members or as a disguised restriction on international trade, without preventing Members from adopting or enforcing measures which are both ‘necessary to protect’ human life or health and ‘based on scientific principles’, and without requiring them to change their appropriate level of protection.”(86)

69.   In US/Canada — Continued Suspension, the Appellate Body first recalled the harmonization objective of the SPS Agreement, outlined in the preamble and further described in Article 3 of the Agreement. Subsequently, the Appellate Body went on to consider the purpose of the latter provision, ruling that it stresses the relevance of international standardization bodies and Members’ right to choose their appropriate level of protection:

“As the preamble of the SPS Agreement recognizes, one of the primary objectives of the SPS Agreement is to ‘further the use of harmonized sanitary and phytosanitary measures between Members, on the basis of international standards, guidelines and recommendations developed by the relevant international organizations’. This objective finds reflection in Article 3 of the SPS Agreement, which encourages the harmonization of SPS measures on the basis of international standards, while at the same time recognizing the WTO Members’ right to determine their appropriate level of protection. Article 3.1 of the SPS Agreement establishes that Members shall ‘base their [SPS] measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided in this Agreement, and in particular in paragraph 3.2.”(87)

2. Article 3.1

(a) General

70.   In US/Canada — Continued Suspension, the Appellate Body specified the “international standards, guidelines and recommendations” considered in Article 3.1 and 3.2 of the SPS Agreement, emphasizing the Codex Alimentarius as the relevant standardization body in matters of food safety:

“The relevant ‘international standards, guidelines or recommendations’ that are referred to in Articles 3.1 and 3.2 are those set by the international organizations listed in Annex A, paragraph 3 of the SPS Agreement, which includes Codex as the relevant standard-setting organization for matters of food safety.”(88)

(b) “base[d] … on”

71.   The Appellate Body in EC — Hormones considered that “based on” is a looser standard than “conform to”. In the Appellate Body’s view, the Panel’s interpretation of the term “based on”, as requiring Members to harmonize their SPS measures by conforming them with international standards(89), was not in accordance with the object and purpose of Article 3, which, the Appellate Body interpreted to be the harmonization of SPS measures, in the future:

“[T]he object and purpose of Article 3 run counter to the Panel’s interpretation. That purpose, Article 3.1 states, is ‘[t]o harmonize [SPS] measures on as wide a basis as possible … It is clear to us that harmonization of SPS measures of Members on the basis of international standards is projected in the Agreement, as a goal, yet to be realized in the future. To read Article 3.1 as requiring Members to harmonize their SPS measures by conforming those measures with international standards, guidelines and recommendations, in the here and now, is, in effect, to vest such international standards, guidelines and recommendations (which are by the terms of the Codex recommendatory in form and nature) with obligatory force and effect.’ The Panel’s interpretation of Article 3.1 would, in other words, transform those standards, guidelines and recommendations into binding norms. But, as already noted, the SPS Agreement itself sets out no indication of any intent on the part of the Members to do so. We cannot lightly assume that sovereign states intended to impose upon themselves the more onerous, rather than the less burdensome, obligation by mandating conformity or compliance with such standards, guidelines and recommendations. To sustain such an assumption and to warrant such a far-reaching interpretation, treaty language far more specific and compelling than that found in Article 3 of the SPS Agreement would be necessary.”(90)

72.   On the Appellate Body’s distinction between the terms “based on” and “conformto” and the requirements for a measure to “conform to” an international standard, refer to the reproduced findings in EC — Hormones, in paragraph 80 below.

(c) “international standards, guidelines or recommendations where they exist”

(i) Panels mandate

73.   With respect to the phrase “international standards … where they exist”, the Panel in EC — Hormones noted that it only needed to determine whether such standards exist rather than considering the level of the standards, the consensus behind them or their adoption process:

Article 3.1 unambiguously prescribes that ‘… Members shall base their sanitary … measures on international standards … where they exist …’ (emphasis added). Paragraph 3 of Annex A of the SPS Agreement states equally clearly that the international standards mentioned in Article 3:1 are ‘for food safety, the standards … established by the Codex Alimentarius Commission relating to … veterinary drug residues …’ (emphasis added). No other conditions are imposed in the SPS Agreement on the relevance of international standards for the purposes of Article 3. Therefore, as a Panel making a finding on whether or not a Member has an obligation to base its sanitary measure on international standards in accordance with Article 3.1, we only need to determine whether such international standards exist. For these purposes, we need not consider (i) whether the standards reflect levels of protection or sanitary measures or the type of sanitary measure they recommend, or (ii) whether these standards have been adopted by consensus or by a wide or narrow majority, or (iii) whether the period during which they have been discussed or the date of their adoption was before or after the entry into force of the SPS Agreement.”(91)

(ii) Relevance of international standards for individual diseases

74.   In Australia — Salmon, in the context of animal health, the Panel held that even if no international standards existed for the entire range of fish diseases at issue, this fact did not signify that an international standard applying to only one of the diseases at issue could not be relevant in the case before it:

Paragraph 3(b) of Annex A to the SPS Agreement indicates that the international standards, guidelines or recommendations referred to in Article 3 for animal health (the concern at issue in this dispute) are those developed under the auspices of the International Office of Epizootics (‘OIE’). Both parties agree that the International Aquatic Animal Health Code adopted by the OIE in 1995 (‘OIE Code’) provides international guidelines on a disease-by-disease basis. However, they also agree that as of today no relevant OIE guideline exists which deals with salmon on a product specific basis. Moreover, both parties also agree that OIE guidelines do not exist for all of the 24 diseases of concern to Australia. Therefore, even if we were to examine first, if and how many relevant international guidelines exist and second address the question of whether Australia deviates from these guidelines, we would thereafter still need to examine either (1) in the event Australia does deviate from any such guidelines contrary to Article 3, whether the measure in dispute could not be based on Australia’s concern for any of the other diseases for which no international guideline exists (in casu, under Articles 2 and 5); or (2) in the event Australia’s measure is based on and/or conforms to any such guidelines, whether that part of the measure for which no guidelines exist, is consistent with the provisions of the SPS Agreement other than Article 3 (in casu, Articles 2 and 5). In this respect, we are of the view, however, that the fact that in this case no international guidelines exist for all 24 diseases of concern does not mean that an international guideline which applies to only one of these diseases cannot be relevant (or, according to the language of Article 3.1, does not ‘exist’) for the measure at issue.”(92)

(iii) Revision and adoption of OIE standards, guidelines and recommendations

75.   The Panel in Australia — Salmon stated as follows, with respect to the standards developed by the OIE:

“[T]he SPS Agreement (paragraph 3(b) of Annex A) explicitly directs us to the OIE and the standards, guidelines and recommendations it develops … The fact that the OIE Code is subject to revision or the way it has been adopted in our view does not change its validity for our purposes.”(93)

(d) Burden of proof

(i) Establishing prima facie inconsistency on the complainants side

76.   In EC — Hormones, the Appellate Body disagreed with the Panel which had held that if a measure enacted by a Member does not conform to an international standard, the complaining Member is exempted from making a prima facie case of inconsistency of this measure with the SPS Agreement or with the GATT 1994(94):

“Under Article 3.1 of the SPS Agreement, a Member may choose to establish an SPS measure that is based on the existing relevant international standard, guideline or recommendation. Such a measure may adopt some, not necessarily all, of the elements of the international standard. The Member imposing this measure does not benefit from the presumption of consistency set up in Article 3.2; but, as earlier observed, the Member is not penalized by exemption of a complaining Member from the normal burden of showing a prima facie case of inconsistency with Article 3.1 or any other relevant Article of the SPS Agreement or of the GATT 1994.”(95)

(e) Relationship with other paragraphs of Article 3

(i) Paragraphs 1, 2 and 3

77.   The Panel in EC — Hormones identified a “general rule–exception” relationship between paragraphs 1, 2 and 3 of Article 3(96). The Appellate Body disagreed with this view:

“The Panel relies on two interpretative points in reaching its … finding. First, the Panel posits the existence of a ‘general rule–exception’ relationship between Article 3.1 (the general obligation) and Article 3.3 (an exception) and applies to the SPS Agreement what it calls ‘established practice under GATT 1947 and GATT 1994’ to the effect that the burden of justifying a measure under Article XX of the GATT 1994 rests on the defending party. It appears to us that the Panel has misconceived the relationship between Articles 3.1, 3.2 and 3.3, a relationship discussed below, which is qualitatively different from the relationship between, for instance, Articles I or III and Article XX of the GATT 1994. Article 3.1 of the SPS Agreement simply excludes from its scope of application the kinds of situations covered by Article 3.3 of that Agreement, that is, where a Member has projected for itself a higher level of sanitary protection than would be achieved by a measure based on an international standard. Article 3.3 recognizes the autonomous right of a Member to establish such higher level of protection, provided that that Member complies with certain requirements in promulgating SPS measures to achieve that level. … merely characterizing a treaty provision as an ‘exception’ does not by itself justify a ‘stricter’ or ‘narrower’ interpretation of that provision than would be warranted by examination of the ordinary meaning of the actual treaty words, viewed in context and in the light of the treaty’s object and purpose, or, in other words, by applying the normal rules of treaty interpretation.”(97)

78.   The Appellate Body in EC — Hormones made the following distinctions between Articles 3.1, 3.2 and 3.3:

“Under Article 3.2 of the SPS Agreement, a Member may decide to promulgate an SPS measure that conforms to an international standard. Such a measure would embody the international standard completely and, for practical purposes, converts it into a municipal standard. Such a measure enjoys the benefit of a presumption (albeit a rebuttable one) that it is consistent with the relevant provisions of the SPS Agreement and of the GATT 1994.

 

Under Article 3.1 of the SPS Agreement, a Member may choose to establish an SPS measure that is based on the existing relevant international standard, guideline or recommendation. Such a measure may adopt some, not necessarily all, of the elements of the international standard. The Member imposing this measure does not benefit from the presumption of consistency set up in Article 3.2; but, as earlier observed, the Member is not penalized by exemption of a complaining Member from the normal burden of showing a prima facie case of inconsistency with Article 3.1 or any other relevant Article of the SPS Agreement or of the GATT 1994.

 

Under Article 3.3 of the SPS Agreement, a Member may decide to set for itself a level of protection different from that implicit in the international standard, and to implement or embody that level of protection in a measure not ‘based on’ the international standard. The Member’s appropriate level of protection may be higher than that implied in the international standard. The right of a Member to determine its own appropriate level of sanitary protection is an important right.”(98)

3. Article 3.2

(a) General

79.   In US/Canada — Continued Suspension, the Appellate Body discussed the presumption of consistency that applies to SPS measures under Article 3.2 of the SPS Agreement. The Appellate Body stated:

Article 3.2 provides that SPS measures which conform to international standards shall be deemed necessary to protect human, animal or plant life or health, and shall be presumed to be consistent with the relevant provisions of the SPS Agreement and of the GATT 1994. This presumption, however, does not apply where a Member has not adopted a measure that conforms with an international standard. Article 3.2 is inapplicable where a Member chooses a level of protection that is higher than would be achieved by a measure based on an international standard. The presumption in Article 3.2 cannot be interpreted to imply that there is sufficient scientific evidence to perform a risk assessment where a Member chooses a higher level of protection.”(99)

(b) “conform to”

80.   In EC — Hormones, the Appellate Body reversed the Panel’s finding that Article 3.2 “equates measures based on international standards with measures which conformto such standards”.(100) The Appellate Body drew a distinction between the terms “based on” and “conform to” and noted certain requirements for a measure to “conform to” an international standard:

“In the first place, the ordinary meaning of ‘based on’ is quite different from the plain or natural import of ‘conform to’. A thing is commonly said to be ‘based on’ another thing when the former ‘stands’ or is ‘founded’ or ‘built’ upon or ‘is supported by’ the latter. In contrast, much more is required before one thing may be regarded as ‘conform[ing] to’ another: the former must ‘comply with’, ‘yield or show compliance’ with the latter. The reference of ‘conform to’ is to ‘correspondence in form or manner’, to ‘compliance with’ or ‘acquiescence’, to ‘follow[ing] in form or nature’. A measure that ‘conforms to’ and incorporates a Codex standard is, of course, ‘based on’ that standard. A measure, however, based on the same standard might not conform to that standard, as where only some, not all, of the elements of the standard are incorporated into the measure.”(101)

81.   The Appellate Body in EC — Hormones, after distinguishing between the ordinary meaning of “based on” and “conform to”, as referred to in paragraph 80 above, noted that they were used in different provisions of the SPS Agreement and rejected the view that such different usage was “merely inadvertent”:

“In the second place, ‘based on’ and ‘conformto’ are used in different articles, as well as in differing paragraphs of the same article. Thus, Article 2.2 uses ‘based on’, while Article 2.4 employs ‘conformto’. Article 3.1 requires the Members to ‘base’ their SPS measures on international standards; however, Article 3.2 speaks of measures which ‘conform to’ international standards. Article 3.3 once again refers to measures ‘based on’ international standards. The implication arises that the choice and use of different words in different places in the SPS Agreement are deliberate, and that the different words are designed to convey different meanings. A treaty interpreter is not entitled to assume that such usage was merely inadvertent on the part of the Members who negotiated and wrote that Agreement. Canada has suggested the use of different terms was ‘accidental’ in this case, but has offered no convincing argument to support its suggestion. We do not believe this suggestion has overturned the inference of deliberate choice.”(102)

(c) Burden of proof

(i) Presumption of consistency

82.   The Appellate Body in EC — Hormones, in the context of addressing the burden of proof under the SPS Agreement, stated that the presumption in Article 3.2 does not mean that Members who decide not to conform their measures with a given international standard may be subject to a special burden of proof as penalty:

“The presumption of consistency with relevant provisions of the SPS Agreement that arises under Article 3.2 in respect of measures that conform to international standards may well be an incentive for Members so to conform their SPS measures with such standards. It is clear, however, that a decision of a Member not to conform a particular measure with an international standard does not authorize imposition of a special or generalized burden of proof upon that Member, which may, more often than not, amount to a penalty.”(103)

83.   The Appellate Body in EC — Hormones also noted that measures pursuant to Article 3.2 enjoy the benefit of a presumption, albeit a rebuttable one.(104) See also paragraph 78 above.

84.   In US/Canada — Continued Suspension, the Appellate Body observed that:

Article 3.2 provides that SPS measures which conform to international standards shall be deemed necessary to protect human, animal or plant life or health, and shall be presumed to be consistent with the relevant provisions of the SPS Agreement and of the GATT 1994. This presumption, however, does not apply where a Member has not adopted a measure that conforms with an international standard. Article 3.2 is inapplicable where a Member chooses a level of protection that is higher than would be achieved by a measure based on an international standard. The presumption in Article 3.2 cannot be interpreted to imply that there is sufficient scientific evidence to perform a risk assessment where a Member chooses a higher level of protection.”(105)

(d) Relationship with other paragraphs of Article 3

85.   The Appellate Body in EC — Hormones clarified the meaning of Article 3.2 while discussing the relationship between Articles 3.1, 3.2 and 3.3. See paragraph 78 above.

(e) Relationship with other Articles

(i) Article 5.1

86.   In US/Canada — Continued Suspension, the Appellate Body reflected on the relevance of Article 3.2 presumption of consistency of the risk assessment under Article 5.1. See paragraph 84 above.

(ii) Article 5.6

87.   The Panel in Australia — Salmon referred to Article 3 in the context of its analysis under Article 5.6:

“Given the repeated reference made in the SPS Agreement to the relevant international organizations, in this dispute the OIE [International Office of Epizootics], and the recommendations they produce (e.g., Articles 3.1 and 5.1), as well as to the more general objective of harmonization (e.g., Articles 3.4 and the sixth preamble), we consider that appropriate weight should be given to [the] opinion on Option 5 [i.e., evisceration of the fish, proposed by the OIE]”.(106)

(iii) Article 5.7

88.   The Appellate Body in US/Canada — Continued Suspension stated that Article 3.2 provides that SPS measures which conform to international standards shall be presumed to be consistent with the relevant provisions of the SPS Agreement and of the GATT 1994. This presumption however, does not apply where a Member has not adopted a measure that conforms with an international standard and can therefore not be interpreted to imply that there is sufficient scientific evidence to perform a risk assessment where a Member chooses a higher level of protection. The Appellate Body found that this situation is borne out by Article 5.7.(107)

4. Article 3.3

(a) General

89.   In EC — Hormones, the Appellate Body held that the “right of a Member to establish its own level of sanitary protection under Article 3.3 of the SPS Agreement is an autonomous right and not an ‘exception’ from a ‘general obligation’ under Article 3.1”.(108) In this respect, see also the excerpts from the Appellate Body report in paragraph 77 above.

90.   The Appellate Body in EC — Hormones found that the right of a Member to define its appropriate level of protection is not an absolute or unqualified right:

“The right of a Member to define its appropriate level of protection is not, however, an absolute or unqualified right. Article 3.3 also makes this clear …”(109)

91.   Regarding the relationship between Article 3.3 and the “precautionary principle”, the Appellate Body in EC — Hormones also noted that the precautionary principle is reflected in Article 3.3.(110)

(b) “based on”

92.   The Appellate Body in EC — Hormones disagreed with the Panel’s finding that “for a sanitary measure to be based on an international standard …, that measure needs to reflect the same level of sanitary protection as the standard”.(111) According to the Appellate Body, the Panel read too much into the text of Article 3.3:

“It appears to us that the Panel reads much more into Article 3.3 than can be reasonably supported by the actual text of Article 3.3. Moreover, the Panel’s entire analysis rests on its flawed premise that ‘based on’, as used in Articles 3.1 and 3.3, means the same thing as ‘conform to’ as used in Article 3.2. As already noted, we are compelled to reject this premise as an error in law.”(112)

93.   For further interpretation of this term as it appears in Article 3.1, see paragraph 71 above.

(c) “relevant international standards, guidelines or recommendations”

94.   In US/Canada — Continued Suspension, the Appellate Body ruled on the relevance of international standards in the SPS Agreement while recognizing the right of a WTO Member to introduce a measure that would result in a higher level of protection than that provided under an international standard:

“There is a rebuttable presumption that SPS measures that conform to international standards, guidelines or recommendations are ‘necessary to protect human, animal or plant life or health, and … [are] consistent with the relevant provisions of this Agreement and of GATT 1994. While use of international standards is encouraged, the SPS Agreement recognizes the right of WTO Members to introduce or maintain an SPS measure which results in a higher level of protection than would be achieved by measures based on such international standards. Where a Member exercises its right to adopt an SPS measure that results in a higher level of protection, that right is qualified in that the SPS measure must comply with the other requirements of the SPS Agreement including the right to perform a risk assessment. However, the Appellate Body has found that the adoption of an SPS measure that does not conform to an international standard and results in a higher level of protection does not give rise to a more exacting burden of proof under the SPS Agreement.”(113)

(d) Compliance with risk assessment requirements

95.   The Appellate Body in EC — Hormones found that footnote to Article 3.3, which defines scientific justification as an “examination and evaluation of available scientific information in conformity with the relevant provisions of this Agreement”, obliges the party that has introduced a measure that results in a level of protection higher than that which would be achieved by measures based on the relevant international standards to comply with the requirements established under Article 5.1:

Article 3.3 is evidently not a model of clarity in drafting and communication. The use of the disjunctive ‘or’ does indicate that two situations are intended to be covered. These are the introduction or maintenance of SPS measures which result in a higher level of protection:

 

(a)   ‘if there is a scientific justification’; or

 

(b)   ‘as a consequence of the level of … protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5’.”

 

It is true that situation (a) does not speak of Articles 5.1 through 5.8. Nevertheless, two points need to be noted. First, the last sentence of Article 3.3 requires that “all measures which result in a [higher] level of … protection”, that is to say, measures falling within situation (a) as well as those falling within situation (b), be “not inconsistent with any other provision of [the SPS] Agreement”. “Any other provision of this Agreement” textually includes Article 5. Secondly, the footnote to Article 3.3, while attached to the end of the first sentence, defines “scientific justification” as an “examination and evaluation of available scientific information in conformity with relevant provisions of this Agreement …”. This examination and evaluation would appear to partake of the nature of the risk assessment required in Article 5.1 and defined in paragraph 4 of Annex A of the SPS Agreement.

 

“On balance, we agree with the Panel’s finding that although the European Communities has established for itself a level of protection higher, or more exacting, than the level of protection implied in the relevant Codex standards, guidelines or recommendations, the European Communities was bound to comply with the requirements established in Article 5.1. We are not unaware that this finding tends to suggest that the distinction made in Article 3.3 between two situations may have very limited effects and may, to that extent, be more apparent than real. Its involved and layered language actually leaves us with no choice.”(114)

(e) “scientific justification”

(i) Rational relationship

96.   In Japan — Agricultural Products II, the Appellate Body recalled its findings in EC Hormones with respect to the relationship between Articles 2.2 and 3.3. Based on these findings, the Appellate Body considered that there is scientific justification for an SPS measure, within the meaning of Article 3.3, if there is a rational relationship between the SPS measure and the available scientific information:

“[T]he context of the phrase ‘not maintained without sufficient scientific evidence’ in Article 2.2 also includes Article 3.3 of the SPS Agreement. Pursuant to Article 3.3, Members may introduce or maintain an SPS measure which results in a higher level of protection than would be achieved by a measure based on a relevant international standard, inter alia, ‘if there is a scientific justification’ and the measure is not inconsistent with any other provision of the SPS Agreement. In European Communities — Hormones, we stated:

 

… the footnote to Article 3.3 … defines ‘scientific justification’ as an ‘examination and evaluation of available scientific information in conformity with relevant provisions of this Agreement … ’.(115)

 

We also stated:

 

[t]his examination and evaluation would appear to partake of the nature of the risk assessment required in Article 5.1 and defined in paragraph 4 of Annex A of the SPS Agreement.

 

In our opinion, there is a ‘scientific justification’ for an SPS measure, within the meaning of Article 3.3, if there is a rational relationship between the SPS measure at issue and the available scientific information.”(116)

(f) Relationship with other paragraphs of Article 3

97.   In EC — Hormones, the Appellate Body revoked the Panel’s finding that Article 3.3 would be an exception to Article 3.1. See 77 above.

98.   As regards the relationship between Articles 3.1, 3.2 and 3.3, see paragraph 78 above.

(g) Relationship with other Articles

(i) Article 1.1

99.   As relates to applicability of the SPS Agreement to measures adopted before 1 January 1995 and measures adopted since, see paragraph 14 above.

(ii) Article 5.1

100.   Based on its analysis of Article 3.3 referenced in paragraph 95 above, the Appellate Body in EC — Hormones concluded that “the Panel’s finding that the European Communities is required by Article 3.3 to comply with the requirements of Article 5.1 is correct”.(117)

5. Article 3.5

101.   With respect to the procedures to monitor the process of international harmonization, see Article 12.4 below.

(a) Relationship with other Articles

102.   With respect to the relationship between Articles 3 and Articles 2 and 5, see paragraphs 65 and 66 above.

 

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V. Article 4  

A. Text of Article 4

Article 4: Equivalence

1.   Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member’s appropriate level of sanitary or phytosanitary protection. For this purpose, reasonable access shall be given, upon request, to the importing Member for inspection, testing and other relevant procedures.

 

2.   Members shall, upon request, enter into consultations with the aim of achieving bilateral and multilateral agreements on recognition of the equivalence of specified sanitary or phytosanitary measures.


B. Interpretation and Application of Article 4

1. Obligation to determine appropriate level of protection

103.   In Australia — Salmon, the Appellate Body noted that although the SPS Agreement does not explicitly oblige Members to determine their appropriate level of protection, such an obligation is implicit in several provisions of the Agreement, including Articles 4.1 and 4.2:

“We recognize that the SPS Agreement does not contain an explicit provision which obliges WTO Members to determine the appropriate level of protection. Such an obligation is, however, implicit in several provisions of the SPS Agreement, in particular, in paragraph 3 of Annex B, Article 4.1(118), Article 5.4 and Article 5.6 of the SPS Agreement.”(119)

2. Decision on equivalence

(a) General

104.   At its meeting of 26 October 2001, the SPS Committee adopted a Decision on the Implementation of Article 4 (“Decision on Equivalence”)(120), which was subsequently clarified and/or revised on 15 November 2002(121), 15 July 2003(122), 26 March 2004(123), 2 April 2004(124), and 23 July 2004.(125) The revision provided, inter alia, clarifications of paragraphs 5, 6 and 7 of the Decision, as foreseen in the Programme for Further Work adopted by the SPS Committee in March 2002.(126) The Committee also adopted a procedure and format for the notification of recognition of equivalence.(127)

105.   The Panel in US — Poultry (China) considered that while the Decision on Equivalence is not binding, it expands on the Members’ own understanding of how Article 4 relates to the rest of the SPS Agreement and how it is to be implemented.(128)

(b) Concept of equivalence

106.   The preamble of the Decision on Equivalence notes that equivalence requires “acceptance of alternative measures that meet an importing Member’s appropriate level of sanitary or phytosanitary protection”, but not duplication or “sameness” of measures. Paragraph 1 of the Decision on Equivalence provides:

“1.   Equivalence can be accepted for a specific measure or measures related to a certain product or categories of products, or on a systems-wide basis. Members shall, when so requested, seek to accept the equivalence of a measure related to a certain product or category of products. An evaluation of the product-related infrastructure and programmes within which the measure is being applied may also be necessary.(129) Members may further, where necessary and appropriate, seek more comprehensive and broad-ranging agreements on equivalence. The acceptance of the equivalence of a measure related to a single product may not require the development of a systems-wide equivalence agreement.”(130)

(c) Explanation of SPS measures taken by importing Member

107.   In order to facilitate the implementation of the provisions of Article 4, the Decision on Equivalence describes the elements to be included in an explanation of the sanitary and phytosanitary measures taken by an importing Member, when so requested by an exporting Member:

(a)   The importing Member should explain the objective and rationale of the sanitary or phytosanitary measure and identify clearly the risks that the relevant measure is intended to address.

 

(b)   The importing Member should indicate the appropriate level of protection which its sanitary or phytosanitary measure is designed to achieve.(131)

 

(c)   The explanation should be accompanied by a copy of the risk assessment on which the sanitary or phytosanitary measure is based or a technical justification based on a relevant international standard, guideline or recommendation.

 

(d)   The importing Member should also provide any additional information which may assist the exporting Member to provide an objective demonstration of the equivalence of its own measure.(132)

(d) Procedure for the recognition of equivalence

(i) General

108.   The Decision on Equivalence provides for a number of requirements and recommendations regarding the procedure to be followed for the recognition of equivalence:

“3.   An importing Member shall respond in a timely manner to any request from an exporting Member for consideration of the equivalence of its measures, normally within a six-month period of time.

 

4.   The exporting Member shall provide appropriate science-based and technical information to support its objective demonstration that its measure achieves the appropriate level of protection identified by the importing Member. This information may include, inter alia, reference to relevant international standards, or to relevant risk assessments undertaken by the importing Member or by another Member. In addition, the exporting Member shall provide reasonable access, upon request, to the importing Member for inspection, testing and other relevant procedures for the recognition of equivalence.

7.   When considering a request for recognition of equivalence, the importing Member should analyze the science-based and technical information provided by the exporting Member on its sanitary or phytosanitary measures with a view to determining whether these measures achieve the level of protection provided by its own relevant sanitary or phytosanitary measures.”(133)

(ii) Accelerated procedure

109.   Paragraph 5 of the Decision on Equivalence provides that “[t]he importing Member should accelerate its procedure for determining equivalence in respect of those products which it has historically imported from the exporting Member.” In the Decision the SPS Committee notes that the importance of knowledge based on historic trade reasons has been fully recognized by other international organizations and international agencies:

“This information and experience, if directly relevant to the product and measure under consideration, should be taken into account in the recognition of equivalence of measures proposed by the exporting Member. In particular, information already available to the importing Member should not be sought again with respect to procedures to determine the equivalence of measures proposed by the exporting Member.”(134)

(iii) Duty not to interrupt or suspend imports

110.   Paragraph 6 of the Decision on Equivalence establishes that “a request by an exporting Member for recognition of the equivalence of its measures with regard to a specific product [by an importing Member] shall not be in itself a reason to disrupt or suspend on-going imports from that Member of the product in question”. The SPS Committee clarifies paragraph 6 of the Decision on Equivalence as follows:

“[S]ince a request for recognition of equivalence does not in itself alter the way in which trade is occurring, there is no justification for disruption or suspension of trade. If an importing Member were to disrupt or suspend trade solely because it had received a request for an equivalence determination, it would be in apparent violation of its obligations under the SPS Agreement (e.g. under Article 2).”(135)

111.   Also in relation to paragraph 6, the Decision on Equivalence provides that a request for recognition of equivalence does not preclude an importing Member from taking measures necessary to achieve the appropriate level of protection:

“[A] request for recognition of equivalence does not impede the right of an importing Member to take any measure it may decide is necessary to achieve its appropriate level of protection, including in response to an emergency situation. However, if the decision to impose some additional control measure were to coincide with consideration by the same Member of a request for recognition of equivalence, this might lead an exporting Member whose trade is affected to suspect that the two events were linked. To avoid any misinterpretation of this kind, the Committee recommends that the importing Member should give an immediate and comprehensive explanation of the reasons for its action in restricting trade to any other Members affected, and that it should also follow the normal or emergency notification procedures established under the SPS Agreement.”(136)

(iv) Comparison of level of protection

112.   Paragraph 7 of the Decision on Equivalence provides that Members should analyse the science-based and technical information provided by the exporting Member on its measures with a view to determining whether these measures achieve the level of protection provided by its own relevant sanitary or phytosanitary measure. The SPS Committee noted, in this regard, that conscientious implementation of the Guidelines to Further the Practical Implementation of Article 5.5 (G/SPS/15) will assist Members in determining equivalence. The Committee suggests that Members consider the Codex approach of establishing an objective basis for comparison or the similar OIE approach when determining the equivalence of sanitary measures, and requests that the Interim Commission on Phytosanitary Measures take into consideration the Decision on Equivalence in its future work on judgment of equivalence.

113.   Furthermore, the SPS Committee agrees that:

“[W]here the objective basis for comparison, or a similar approach established by a relevant international organization, demonstrates that the level of protection achieved by the importing Member’s sanitary or phytosanitary measure differs from its appropriate level of protection, the importing Member should resolve this difference independently of the procedure for determination of equivalence.”(137)

(v) Technical assistance

114.   Paragraph 8 of the Decision on Equivalence provides further that, in line with Article 9 of the SPS Agreement, Members shall give full consideration to requests for appropriate technical assistance to facilitate the implementation of Article 4, especially when those requests come from developing countries:

“In accordance with Article 9 of the Agreement on the Application of Sanitary and Phytosanitary Measures, a Member shall give full consideration to requests by another Member, especially a developing country Member, for appropriate technical assistance to facilitate the implementation of Article 4. This assistance may, inter alia, be to help an exporting Member identify and implement measures which can be recognized as equivalent, or to otherwise enhance market access opportunities. Such assistance may also be with regard to the development and provision of the appropriate science-based and technical information referred to in paragraph 4, above.”(138)

(e) International cooperation outside the WTO

115.   In order to improve international cooperation in this sphere outside the WTO, paragraph 9 of the Decision on Equivalence advises active participation of Members in the ongoing work in the Codex Alimentarius Commission and in any work related to equivalence undertaken by the World Organisation for Animal Health and in the framework of the International Plant Protection Convention.

116.   Paragraph 10 of the Decision on Equivalence outlines a number of actions to be taken by the SPS Committee in this regard:

“The Committee on Sanitary and Phytosanitary Measures recognizes the urgency for the development of guidance on the judgement of equivalence and shall formally encourage the Codex Alimentarius Commission to complete its work with regard to equivalence as expeditiously as possible. The Committee on Sanitary and Phytosanitary Measures shall also formally encourage the World Organization for Animal Health and the Interim Commission on Phytosanitary Measures to elaborate guidelines, as appropriate, on equivalence of sanitary and phytosanitary measures and equivalence agreements in the animal health and plant protection areas. The Codex Alimentarius Commission, the World Organization for Animal Health and the Interim Commission on Phytosanitary Measures shall be invited to keep the Committee on Sanitary and Phytosanitary Measures regularly informed regarding their activities relating to equivalence.”(139)

(f) Notification

117.   In accordance with paragraph 12 of the Decision on Equivalence, Members should regularly inform the SPS Committee of their experiences concerning the implementation of Article 4. In particular, the Decision encourages Members to inform the SPS Committee of the successful conclusion of any bilateral equivalence agreement.(140)

3. Specific programme for the further implementation of Article 4

118.   Paragraph 13 of the initial Decision on Equivalence asks the SPS Committee to develop a specific programme to further the implementation of Article 4, paying particular attention to the problems encountered by developing country Members.(141) At the Doha Ministerial Conference, Members also instructed the SPS Committee to develop the same specific programme.(142) At its meeting of 21 March 2002, the SPS Committee adopted a specific programme for the further implementation of Article 4.(143) The programme established the timetable and the agendas of the meetings for the discussion of the Decision on Equivalence, and resulted in the subsequent revisions of the Decision.

4. Relationship with other Articles

(a) General

119.   The Panel in US — Poultry (China) in reviewing the text of Article 4 and the Decision on Equivalence observed that Article 4 is not the only provision in the SPS Agreement that regulates the operation of equivalence regimes. The Panel therefore reasoned that this provision should not be applied in isolation from other relevant provisions of the SPS Agreement. The Panel stated:

“[T]he Panel sees nothing in Article 4 or the Decision which suggests that Article 4 is the only provision in the SPS Agreement which regulates the operation of equivalence regimes, including their ‘procedural requirements’ or that it should be applied in isolation from other relevant provisions of the SPS Agreement. In fact, the Decision states that the importing Member should explain its SPS measures by identifying the risk and provide a copy of the risk assessment or technical standard on which the measure is based. Further, it requires the importing Member to analyse the science-based and technical information provided by the exporting Member with respect to that Member’s own SPS measure( s) to examine if the measure achieves the importing Member’s ALOP.

 

The Decision, therefore, implies that measures taken as part of an equivalence regime, subject to Article 4, should also comply with other relevant provisions of the SPS Agreement.”(144)

120.   The Panel in US — Poultry (China) concluded that a determination of the particular provisions applicable to a given measure must be done on a case-by-case basis. With specific reference to Article 4, the Panel determined that nothing in Article 4 a priori precludes a given measure from being subject to the disciplines of Articles 2, 4 and 5 at the same time.(145)

(b) Article 2.2

121.   The Panel in Japan — Apples held that, while Article 4 might form part of the relevant context in the interpretation of Article 2.2, its purpose is clearly different from that of Article 2.2. Thus, in the assessment of claims under Article 2.2, a panel need not take into account the requirements of Article 4:

“Japan also argues that we should take into account the requirements of Article 4 of the SPS Agreement when considering whether the measure at issue is supported by sufficient scientific evidence. We agree that other provisions of the SPS Agreement are part of the context of Article 2.2, as recalled by the Appellate Body in Japan — Agricultural Products II.(146) However, Article 4 deals with the specific question of the recognition of equivalence of measures. Unlike Articles 3.3, 5.1 and 5.7, the purpose of Article 4 is clearly different from that of Article 2.2. We also note that the United States did not raise any claim under Article 4 and that this Article is not a defence against violations of other provisions of the SPS Agreement. As a result, we see no reason to consider Japan’s arguments regarding Article 4 in our assessment of Article 2.2, other than to the extent that Article 4 might form part of the relevant context in the interpretation of Article 2.2.”(147)

 

 

 

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