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PONTIFICIA UNIVERSIDAD JAVERIANA

The General Scientific Obligation of the SPS Agreement: Risk

Assessments, Precautionary Actions and the Exception -

Exemption Debate

Carlos Ignacio Arboleda Suárez

Directed by: Miguel Ángel Castro Riberos

NOTA DE ADVERTENCIA

“Resolución No. 13 de Julio de 1946, artículo 23: La universidad no se

hace responsable por los conceptos emitidos por sus alumnos en sus

trabajos de tesis. Solo velará por que no se publique nada contrario al

dogma y a la moral católica y por que las tesis no contengan ataques

personales contra persona alguna, antes bien se vea en ellas el anhelo de

buscar la verdad y la justicia.”

Contraportada

THE GENERAL SCIENTIFIC OBLIGATION OF THE SPS AGREEMENT:

RISK ASSESSMENTS, PRECAUTIONARY ACTIONS AND THE

EXCEPTION – EXEMPTION DEBATE

CARLOS IGNACIO ARBOLEDA SUÁREZ

Directed by: Miguel Ángel Castro Riberos

i

ABSTRACT

The Agreement on the Application of Sanitary and Phytosanitary Measures pretended

to harmonize this type of measures around the objective parameters of scientific

information, thus avoiding arbitrary restrictions to international trade. Nevertheless,

the rules set regarding the use of scientific evidence have built a complex obligation

that is difficult to fulfill. It is the purpose of this document to address those provisions,

their extent and the main problems their interpretation has caused in the world of the

WTO.

Key words: WTO, SPS Agreement, International Trade

ii

TABLE OF CONTENTS

Introduction……………………………………………………………………...

1

1. SPS Measures in the WTO…………………………………………………... 3

a. GATT 1947……………………………………………………………………. 3

b. The SPS Agreement……………………………………………………………

6

2. The General Scientific Obligation of Articles 2.2 and 5.1…………………. 19

a. Article 2.2 and its Interpretation………………………………………………. 19

b. Article 5.1 and its Interpretation………………………………………………. 25

c. Relationship Between Articles 2.2 and 5.1 of the SPS Agreement……………

33

3. The Special Case of SPS Article 5.7………………………………………… 35

a. Article 5.7 and its Interpretation……………………………………………… 35

b. The Precautionary Principle…………………………………………………... 39

c. The Nature of SPS Article 5.7…………………………………………………

43

4. Overall View of the General Scientific Obligation of the SPS Agreement..

50

5. Key Issues of the General Scientific Obligation of the SPS Agreement….. 54

a. Does the SPS Agreement Establish a Parameter Too Rigorous for SPS

Measures?...............................................................................................................

54

b. Is the Precautionary Principle Compatible with the SPS Agreement?............... 59

c. Article 5.7: Exception or Exemption?................................................................

62

6. Conclusions…………………………………………………………………… 66

iii

LIST OF ABBREVIATIONS

ABR……………………………………………………………... Appellate Body Report

EC………………………………………………………………… European Community

fn./fns………………………………………………………………… footnote/footnotes

GATT………………………………………… General Agreement on Tariffs and Trade

para./paras………………………………………………………... paragraph/paragraphs

pg./pgs………………………………………………………………………... page/pages

PR………………………………………………………………………….. Panel Report

SPS Agreement……………………………… Agreement on the Application of

Sanitary and Phytosanitary Measures

US………………………………………………………………………….. United States

WTO…………………………………………………………. World Trade Organization

iv

LIST OF REFERENCES

REPORTS:

REPORT ABBREVIATION

Panel Report, Australia – Measures Affecting

Importation of Salmon, WT/DS18/R, 12 June

1998

PR, Australia - Salmon

Appellate Body Report, Australia – Measures

Affecting Importation of Salmon,

WT/DS18/AB/R, 20 October 1998

ABR, Australia - Salmon

Panel Report, European Communities – Measures

Affecting the Approval and Marketing of Biotech

Products, WT/DS291/R, WT/DS292/R,

WT/DS293/R, 29 September 2006

PR, EC – Biotech

Panel Report, European Communities – Measures

Concerning Meat and Meat Products (Hormones),

Complaint by the United States,

WT/DS26/R/USA, 18 August 1997

Panel Report, European Communities – Measures

Concerning Meat and Meat Products (Hormones),

Complaint by Canada, WT/DS48/R/CAN, 18

August 1997

PR, EC – Hormones

Appellate Body Report, EC – Measures

Concerning Meat and Meat Products,

WT/DS26/AB/R – WT/DS48/AB/R, 16 January

1998

ABR, EC – Hormones

Panel Report, EC – Anti-Dumping Duties on

Malleable Cast Iron Tube or Pipe Fittings From

Brazil, WT/DS219/R, 7 March 2003

PR, EC – Pipe Fittings

Appellate Body Report, EC – Conditions for the

Granting of Tariff Preferences to Developing

Countries, WT/DS246/AB/R, 7 April 2004

ABR, EC – Tariff Preferences

Panel Report, Japan – Measures Affecting the

Importation of Apples, WT/DS245/R, 15 July

2003

PR, Japan – Apples

Appellate Body Report, Japan – Measures

Affecting the Importation of Apples,

WT/DS245/AB/R, 26 November 2003

ABR, Japan – Apples

Panel Report, Japan – Measures Affecting

Agricultural Products, WT/DS76/R, 27 October

1998

PR, Japan – Agricultural

Products II

Appellate Body Report, Japan – Measures

Affecting Agricultural Products, WT/DS76/AB/R,

22 February 1999

ABR, Japan – Agricultural

Products II

Appellate Body Report, Korea – Measures

Affecting Imports of Fresh, Chilled and Frozen

Beef, WT/DS161/DS169/AB/R, 11 December

2000

ABR, Korea – Beef

v

Panel Report, Korea – Measures Affecting

Government Procurement, WT/DS163/R, 1 May

2000

PR, Korea – Government

Procurement

Panel Report, Turkey – Restrictions on Import of

Textile and Clothing Products, WT/DS34/R, 31

May 1999

PR, Turkey – Textiles

Panel Report, US – Continued Suspension of

Obligations in the EC – Hormones Dispute,

WT/DS320/R, 31 March 2008

PR, US – Continued Suspension

Appellate Body Report, US – Sunset Review of

Anti-Dumping Duties on Corrosion-Resistant

Carbon Steel Flat Products From Japan,

WT/DS244/AB/R, 15 December 2003

ABR, US – Corrosion Resistant

Steel Sunset Review

Appellate Body Report, US – Standards for

Reformulated and Conventional Gasoline,

WT/DS2/AB/R, 29 April 1996

ABR, US – Gasoline

Panel Report, US – Certain Measures Affecting

Imports of Poultry From China, WT/DS392/R, 29

September 2010

PR, US – Poultry

Appellate Body Report, US – Measure Affecting

Imports of Woven Wool Shirts and Blouses From

India, WT/DS33/AB/R, 25 April 1997

ABR, US – Wool Shirts and

Blouses

GATT REPORTS:

United States – Section 337 of the Tariff Act of 1930, GATT Panel Report,

November 7 1989 (GPR, US – Section 337).

BOOKS, JOURNALS AND OTHER DOCUMENTS:

Broude, Tomer, Genetically Modified Rules: The Awkward Rule-Exception-

Right Distinction in EC-Biotech. International Law Forum, The Hebrew

University of Jerusalem (2006).

Committee on Sanitary and Phytosanitary Measures, Summary Report on the

SPS Risk Analysis Workshop, G/SPS/GEN/209 (2000).

Griffin, R., Agreement on the Application of Sanitary and Phytosanitary

Measures (SPS) and Agreement on Technical Barriers to Trade (TBT), Module

I: History of the Development of the SPS Agreement, Food and Agriculture

Organization (FAO). Available at:

http://www.fao.org/docrep/003/X7354E/X7354e01.htm

Matsushita, Mitsuo; Schoenbaum, Thomas J; Mavroidis, Petros C., The World

Trade Organization: Law, Practice and Policy, Oxford International Law

Library: 2006.

vi

Shapiro, Hal S., The Rules That Swallowed the Exceptions: The WTO SPS

Agreement and its Relationship to GATT Articles XX and XXI, Arizona Journal

of International and Comparative Law, Vol. 24, No. 1 (2007).

Van den Bossche, Peter, The Law and Policy of the World Trade Organization:

Text, Cases and Materials, Cambridge University Press: 2005.

World Commission on the Ethics of Scientific Knowledge and Technology

COMEST, The Precautionary Principle, UNESCO: 2005.

World Trade Organization, The Agreement on the Application of Sanitary and

Phytosanitary Measures, WTO E-Learning.

Yanovich, Alan; Voon, Tania, What is the Measure at Issue? In Challenges and

Prospects for the WTO, Cameron May Ltd: 2005.

TREATIES AND AGREEMENTS:

Agreement on the Application of Sanitary and Phytosanitary Measures, 1994.

Agreement on Implementation of Article VI of the General Agreement on

Tariffs and Trade 1994, Antidumping Agreement, 1994.

Agreement on Implementation of Article VII of the General Agreement on

Tariffs and Trade 1994, Customs Valuation Agreement, 1994.

Agreement on Safeguards, 1994.

Agreement on Subsidies and Countervailing Measures, 1994.

General Agreement on Tariffs and Trade, GATT, 1994.

Rio Declaration on Environment and Development, 1992.

1

INTRODUCTION

World trade has been multilaterally regulated since 1947 through the General

Agreement on Tariffs and Trade (“GATT”), which establishes the principles applicable

to international trade in goods. Nevertheless, seeking depth, in 1994 the GATT became

only one of the various treaties within the newly created World Trade Organization

(“WTO”). The WTO expanded regulations in trade through a series of agreements

(“Covered Agreements”) regarding trade in goods, services, investment, intellectual

property and dispute settlement, among others.

In that sense, GATT lost its “exclusiveness” as the sole tool for trade regulation, to

make way for a more complex system. One of those instruments is the Agreement on

the Application of Sanitary and Phytosanitary Measures (the “SPS Agreement”), which

is in charge of setting the standards for measures aimed at protecting human, animal or

plant life or health, that have a trade impact for them not to become an arbitrary

restriction to trade.

The key element within the rules of the SPS Agreement is the role of scientific

information, since it is the objective parameter used to analyze the consistency of a

given measure. Three specific provisions in the SPS Agreement refer to the scientific

burden: the main obligation of Article 2.2, its development regarding risk assessment in

Article 5.1, and the special situation contained in Article 5.7. However, the rules set

forth in these provisions are not clear, and have given rise to important debates as to

their interpretation and extent. Therefore, the question that arises is: what is the extent

of the general scientific obligation of the SPS Agreement?

In order to properly respond to the previous question, the three provisions, Articles

2.2, 5.1 and 5.7, will be analyzed independently, taking into account the wording of the

2

provisions, as well as Panel and Appellate Body decisions in order to arrive to a full

interpretation of these rules. Then, an overall view of the general scientific obligation

will be explored, taking into account the particular characteristics of each provision, and

finally tackle three of the most important debates that have arisen from them: (i) the

strictness of the general scientific obligation, (ii) the role of the precautionary principle,

and (iii) the nature of Article 5.7.

Chapter 1 of this document refers to the history of the SPS Agreement, its

development from GATT and the implications of their relationship. Chapter 2 explores

the extent and interpretation of Articles 2.2 and 5.1, as well as their particular bond.

Chapter 3 is dedicated to the third provision of the general scientific obligation: Article

5.7. Chapter 4 pretends to summarize and condense the conclusions drawn from the two

previous chapters in a global, more complete view of the general scientific obligation of

the SPS Agreement. Chapter 5, on its part, is aimed at tackling the three points indicated

in the previous paragraph. Finally, Chapter 6 will include the conclusions of the

analysis of the general scientific obligation.

3

1. SPS MEASURES IN THE WTO

Despite being true that the WTO seeks free, liberalized international trade between

its members, it is inevitable that certain measures adopted by countries wind up being

restrictive of international trade. Therefore, the rules of WTO agreements seek not to

prohibit any limitation to international trade, but rather regulate them, indicating the

conditions and extent to which restrictions to trade are acceptable. The protection of life

and health is, undeniably, an extremely important objective that states pursue, and that

can sometimes restrict international trade. GATT itself, since 1947, has recognized this

situation.

It is the purpose of the first section to show the development of the protection of life

and health within GATT, the necessity that arose to regulate the matter independently

and finally the creation of SPS Agreement, along with its relationship with GATT.

a. GATT 1947

Since GATT was created in 1947, the protection of life and health has been an issue

worthy of regulation in international trade. GATT contains certain provisions that are

considered to be justifications for the application of measures that restrict international

trade that relate with these matters. The most important rule is paragraph (b) of Article

XX (“General Exceptions”), which permits the adoption of measures that, despite

being trade restrictive, are aimed at protecting human, animal or plant life or health.

In other words, a measure based on one of the objectives set forth in paragraph (b) of

Article XX despite violating GATT provisions, is found justified, and therefore WTO-

consistent.

Article XX of GATT in its relevant part, states:

4

“Subject to the requirement that such measures are not applied in a manner

which would constitute a means of arbitrary or unjustifiable discrimination

between countries where the same conditions prevail, or a disguised restriction

on international trade, nothing in this Agreement shall be construed to prevent the

adoption or enforcement by any contracting party of measures:” (Underlining not

in the original text)

Pursuant to this provision, a measure that violates any of the GATT commitments

can be justified by any Member as long as it: (i) follows one of the objectives listed in

Article XX (a) to (j); and, (ii) does not encompass a disguised restriction on

international trade1.

As to the first requirement, the protection of human, animal or plant life and health is

recognized as one of the legitimate objectives for the purposes of Article XX. The

relevant paragraph reads as follows:

(b) necessary to protect human, animal or plant life or health;

As can be seen from the text of this provision, the measure must be “necessary” for

the protection of life and health2. WTO Adjudicating Bodies have interpreted this

concept under Article XX of the GATT. For instance, the Panel in the case US – Section

337 understood necessity in relation to the existence or not of alternative measures3.

The Appellate Body in Korea – Beef recalled that conclusion; stating that there must be

a “weighing and balancing” process of the reasons that support the adoption of a

measure to conclude the existence of necessity. Furthermore, it pointed out that the

1 Committee on Sanitary and Phytosanitary Measures, Summary Report on the SPS Risk Analysis

Workshop, G/SPS/GEN/209 (2000). p. 2. 2 The term “necessary” appears also in GATT Article XX (a) and (d), which refer respectively to

measures that seek to protect public morals, life and health, and customs enforcements. 3 PR, US – Section 337, footnote 69, para. 5.26.

5

decision of compliance with necessity “is comprehended in the determination of

whether a WTO-consistent alternative measure which the Member concerned could

"reasonably be expected to employ" is available, or whether a less WTO-inconsistent

measure is "reasonably available".”4 So, a measure will be necessary if the objective

sought cannot be obtained through a non-restrictive alternative measure to the one

adopted.

Regarding the second requirement, that is that the measure is not a disguised

restriction on international trade, the negative burden seeks that the measure is not an

unfair restriction to trade, since life and health protection could be used as a pretext,

rather than as a legitimate objective. The Appellate Body, in US – Gasoline, interpreted:

“The chapeau is animated by the principle that while the exceptions of Article XX

may be invoked as a matter of legal right, they should not be so applied as to

frustrate or defeat the legal obligations of the holder of the right under the

substantive rules of the General Agreement. If those exceptions are not to be

abused or misused, in other words, the measures falling within the particular

exceptions must be applied reasonably, with due regard both to the legal duties of

the party claiming the exception and the legal rights of the other parties

concerned.

(…) We consider that "disguised restriction", whatever else it covers, may

properly be read as embracing restrictions amounting to arbitrary or

unjustifiable discrimination in international trade taken under the guise of a

measure formally within the terms of an exception listed in Article XX. (…) The

fundamental theme is to be found in the purpose and object of avoiding abuse or

4 ABR, Korea – Beef, para. 166.

6

illegitimate use of the exceptions to substantive rules available in Article XX.”5

In conclusion, under GATT, Article XX (b) is the only provision that addressed

measures intended to protect human, animal and plant life and health. Therefore, a

measure that sought those objectives had to follow the test previously explained,

complying with the two aforementioned requirements, in order to be WTO-consistent.

Furthermore, since Article XX (b) contains a defense to justify violations of GATT,

the measure would only be analyzed in the event that it resulted challenged in a dispute

settlement procedure. Hence, the analysis of WTO consistency turned out to be

secondary, ex-post, to a claim of violation under another GATT obligation.

Nevertheless, GATT Article XX(b) needed to be more extensively regulated and so,

in 1994, the SPS Agreement came into existence.

b. THE SPS AGREEMENT

As mentioned above, between 1947 and 1994, no objective parameter was applicable

to life and health protective measures, other than the treatment given as exceptions to

GATT obligations. Nevertheless, these measures needed to be regulated entirely, so it

became the duty of an independent agreement to do so: the SPS Agreement.

“During the 1970's, the idea emerged that a specific agreement on technical

barriers to trade was necessary. A plurilateral agreement on technical barriers to

trade (or "standards code") was then negotiated during the Tokyo round (1973

1979). Although this agreement was not developed primarily for the purpose of

regulating sanitary and phytosanitary measures, it covered technical

requirements, and among these, those resulting from food safety and human,

5 ABR, US – Gasoline, pgs. 24 – 25.

7

animal and plant health measures (which include pesticide residue limits,

inspection requirements and labeling).

During the Uruguay round (1985-1994), it was felt that there was a need for more

specific rights and obligations with respect to food safety and human, animal and

plant health measures affecting international trade. An agreement on the

application of sanitary and phytosanitary measures was thus negotiated during

that round of negotiations in a working group under the agriculture committee.”6

What the SPS Agreement finally entails is a non-tariff barrier to trade. These are

restrictions to free trade which do not respond to the form of tariffs, the type of barriers

that should prevail in the WTO system and are regulated by GATT since 1947.

In the history of the SPS, the goal of harmonization of sanitary and phytosanitary

measures, as a non-tariff barrier to trade, that was sought in the Uruguay round was

supported strongly by developing countries, concerned about the possibility of

developed countries of imposing strict, arbitrary standards7.

“The Working Group on Sanitary and Phytosanitary Regulations, which was

formed in 1988, produced a draft text in November 1990. A consensus was

reached by the parties on the following points: SPS measures should not

represent disguised trade barriers; should be harmonized on the basis of

generally-accepted scientific principles; special consideration should be given to

developing countries; transparency should be ensured in setting regulations and

in solving disputes; and an international committee should be established to

6 World Trade Organization, The Agreement on the Application of Sanitary and Phytosanitary Measures,

WTO E-Learning, pg. 5. 7 See: Griffin, R., Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and

Agreement on Technical Barriers to Trade (TBT), Module I: History of the Development of the SPS

Agreement, Food and Agriculture Organization (FAO).

8

provide for consultations regarding standards.”8

The working group’s draft was finally agreed upon and became the SPS Agreement.

It is derived from GATT itself, as a means to harmonize and set forth relevant rules for

the adoption of trade-restrictive measures needed to protect life and health, but taking

into account objective parameters, thus not allowing arbitrary restrictions.

(i) Elaborating GATT 1947

The mandate of GATT Article XX is replicated in the very first sentence of the SPS

Agreement, stating in its Preamble 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”.

Both GATT and the Preamble of the SPS Agreement recognize the right to protect

human, animal or plant life or health, recognizing as well that it is not an unlimited one.

The relationship between GATT Article XX(b) and the SPS Agreement is explicit

from the very Preamble of the latter, when it states:

“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)”

The Panel, in the US – Poultry case concluded that “the preamble uses the word

"elaborate" to qualify the relationship of the SPS Agreement with Article XX(b). The

ordinary meaning of the word "elaborate" is to "explain something in detail".

8 Ibidem.

9

Accordingly, when the preamble states that the SPS Agreement elaborates the rules for

the application of Article XX(b), it is thus saying that the SPS Agreement "explains in

detail" how to apply Article XX(b).”9 The Panel, in EC – Hormones, stated that, for

instance, Article 2 of the SPS Agreement (“main obligations”) is a further development

of GATT Article XX(b)10

.

It is important to recall that, as the SPS Agreement is, several WTO Covered

Agreements are developments of GATT provisions. For example, the Customs

Valuation Agreement with respect to GATT Article VII11

, the Anti-Dumping

Agreement and the Agreement on Subsidies and Countervailing Measures (“SCM”)

regarding GATT Article VI12

, and the Agreement on Safeguards with GATT Article

XIX13

.

The relation between the GATT provisions and other Covered Agreements is

different in each case. In the following section the implications and effects of the

relationship between Article XX (b) and the SPS Agreement will be examined.

(ii) The Implications of the SPS Agreement as a Development of GATT Article XX(b)

The fact that the SPS Agreement defines itself as an elaboration of GATT has

9 PR, US – Poultry, para. 7.471.

10 PR, EC – Hormones, paras. 8.38-8.40.

11 The Preamble of the Customs Valuation Agreement states: "Recognizing the importance of the

provisions of Article VII of GATT 1994 and desiring to elaborate rules for their application in order to

provide greater uniformity and certainty in their implementation". 12

Article 1 of the Anti-Dumping Agreement reads: "An anti-dumping measure shall be applied only

under the circumstances provided for in Article VI of GATT 1994 and pursuant to investigations initiated

and conducted in accordance with the provisions of this Agreement. The following provisions govern the

application of Article VI of GATT 1994 in so far as actions taken under anti-dumping legislation or

regulations."

Article 10 of the SCM Agreement provides: “Members shall take all necessary steps to ensure that the

imposition of a countervailing duty on any product of the territory of any Member imported into the

territory of another Member is in accordance with the provisions of Article VI of GATT 1994 and the

terms of this Agreement.” 13

The Agreement on Safeguards states in its Preamble: "Recognizing the need to clarify and reinforce the

disciplines of GATT 1994, and specifically those of its Article XIX (Emergency Action on Imports of

Particular products), to re-establish multilateral control over safeguards and eliminate measures that

escape such control".

10

consequences of great interest. Firstly it must be noted that the SPS Agreement, albeit

deriving from GATT, is a “stand-alone”14

agreement, and therefore it has autonomous

rights and obligations, independent and different from those of GATT. Hence, despite

their closeness, they are different agreements and must be treated accordingly.

Nevertheless, the SPS Agreement sets forth an important rule to be taken into

account when analyzing a measure under the SPS Agreement:

“Article 2

Basic Rights and Obligations

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).” (Underlining not in the original text)

This article establishes a presumption of compliance: a measure that complies with

the SPS Agreement, is presumed to be consistent with GATT Article XX(b). This

presumption is, however, rebuttable15

. Hence, since the presumption may be rebutted,

the fact that a certain measure complies with the provisions of the SPS Agreement

makes it apparently compliant with GATT as well, but it can be proved otherwise.

Now, the question that rises is if there is a similar presumption of consistency in

respect to the SPS Agreement when there is evidence of compliance with Article XX

(b). In other words, does the SPS Agreement exhaust GATT Article XX(b)?

14

Shapiro, Hal S., The Rules That Swallowed the Exceptions: The WTO SPS Agreement and its

Relationship to GATT Articles XX and XXI, Arizona Journal of International and Comparative Law, Vol.

24, No. 1 (2007). p. 203. 15

Shapiro, p. 204.

11

The Panel in the US – Poultry case addressed this issue indicating:

“Therefore, if the Panel were to find that Section 727 is an SPS measure, a

finding that it is not inconsistent with the SPS Agreement, would yield a

presumption that Section 727 is in accordance with Article XX(b) of the GATT

1994. Accordingly, the Panel would not need to consider the GATT claims

because the measure would be presumed to be consistent with Article XX(b).

However, we agree with China in that there is no presumption of consistency with

the SPS Agreement for measures that are found to be consistent with Article

XX(b) of the GATT 1994. Hence, if the Panel were to start with the claims under

GATT 1994 and find Section 727 to be consistent with that Agreement, then the

Panel would still have to look at the SPS claims, because a measure consistent

with the GATT 1994 is not presumed necessarily to be consistent with the SPS

Agreement.”16

In this case, the Panel clarified that a measure that complies with Article XX(b) is

not necessarily compliant with the SPS Agreement, despite the fact that compliance

with the latter does raise a presumption of compliance with the former. It further noted:

“We also note that the definition of SPS measures in Annex A(1) of the SPS

Agreement, although not referring directly to Article XX(b) of the GATT 1994,

does encompass measures applied to protect animal or plant life or health as well

as human life or health. We recall that Article XX(b) of the GATT 1994 refers to

measures "necessary to protect human, animal or plant life or health". Hence, the

same type of measures. Although Article XX(b) of the GATT 1994 could be seen

as encompassing more measures than those defined in Annex A(1) of the SPS

16

PR, US – Poultry, para. 7.67.

12

Agreement; measures of the type defined in Annex A(1) are included within the

type of measures contemplated in Article XX(b) of the GATT 1994.”17

(Underlining not in the original text).

What the Panel indicated in its report was that, despite that the SPS measures are of

the same type of measures than those addressed by GATT Article XX(b), as both of

them seek to protect life and health, there can be measures that fall under the scope of

the GATT but not under the SPS Agreement.

Moreover, the presumption of compliance has been given an additional reach. The

Panel, in the case indicated above, stated that a measure that falls within the scope of

the SPS Agreement but is inconsistent with the main obligations of that Agreement

(Articles 2 and 5) cannot fall under, and hence cannot be justified by, Article XX(b) of

GATT:

“Given our conclusion that the SPS Agreement explains the provisions of Article

XX(b) in further detail and because the SPS Agreement only applies to SPS

measures, the SPS Agreement thus explains in detail the provisions of Article

XX(b) in respect of SPS measures. Since that is the case, we have difficulty in

accepting that an SPS measure which is found inconsistent with provisions of the

SPS Agreement such as Articles 2 and 5, which are explanations of the disciplines

of Article XX(b), could be justified under that same provision of the GATT1994.

Additionally, we recall that Article 2.1 of the SPS Agreement provides that

Members have a right to take SPS measures necessary for the protection of

human, animal, or plant life or health, provided that such measures are not

inconsistent with the provisions of the SPS Agreement. Therefore, the Panel is of

17

PR, US – Poultry, para. 7.475.

13

the view that an SPS measure which has been found inconsistent with Articles 2

and 5 of the SPS Agreement, cannot be justified under Article XX(b) of the GATT

1994.

We are not deciding that any analysis of Article XX(b) must be done with

reference to the SPS Agreement. We are only saying that, where an SPS measure

is concerned, the provisions of the SPS Agreement become relevant for an

analysis of Article XX(b) and, furthermore, where such an SPS measure has been

found inconsistent with provisions of the SPS Agreement such as Articles 2 and 5,

the disciplines of Article XX(b) cannot be applied so as to justify such a

measure.”18

(Underlining not in the original text)

This finding by the Panel is one of the rare cases of an irrefutable presumption. The

Panel is emphatic in the impossibility under WTO rules of finding a measure consistent

with GATT Article XX(b) if it violates SPS Articles 2.2 and/or 5.1, leaving no room to

prove otherwise19

.

In sum, the implications of the SPS Agreement as a development of GATT Article

XX(b) are:

The SPS Agreement does not exhaust GATT Article XX(b). Therefore, there

can be measures justified under that GATT provision that do not fall under

the scope of the SPS Agreement.

A measure that does fall under the scope of the SPS Agreement and fulfills its

requirements is covered by a rebuttable presumption of compliance with

GATT Article XX(b).

18

PR, US – Poultry, paras. 7.481-7.482. 19

The Panel report in the Poultry case was never appealed, since the measure at issue expired before the

Panel report was adopted. Hence the Appellate Body has never had an opportunity to refer to this

presumption. See PR, US – Poultry, paras. 8.7-8.10.

14

A measure that falls under the scope of the SPS Agreement can never be

justified by GATT Article XX(b) if it does not comply with Articles 2 and 5

of the SPS Agreement.

An SPS measure complying with GATT Article XX(b) is not presumed to be

consistent with the SPS Agreement.

(iii) The scope of application of the SPS Agreement

Article 1.1 of the SPS Agreement limits the scope of application to SPS measures

that may, either directly or indirectly, affect international trade20

. From the wording of

this provision it has been interpreted that two requirements must be met for a measure to

be assessed under the SPS Agreement: (i) the measure must be an SPS measure; and,

(ii) it must affect, or have the potential to affect international trade21

. The second

requirement has not been subjected to further interpretation since it does not state that

actual negative effects need to occur, but just the mere possibility that they may arise22

.

However, the delimitation of SPS measures does require further scrutiny.

The characteristics of an SPS measure are found in Annex A1 of the SPS Agreement

entitled “Definitions”:

“1. Sanitary or phytosanitary measure - Any measure applied:

(a) to protect animal or plant life or health within the territory of the Member

from risks arising from the entry, establishment or spread of pests, diseases,

disease-carrying organisms or disease-causing organisms;

20

Article 1.1 of the SPS Agreement states:

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. 21

PR, EC – Hormones, para. 8.36; PR, US – Poultry, para. 7.82. 22

Only in one SPS-related case has this requirement been explained, EC – Biotech. PR, EC – Biotech,

para. 7.435.

15

(b) 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;

(c) to protect human life or health within the territory of the Member from risks

arising from diseases carried by animals, plants or products thereof, or from the

entry, establishment or spread of pests; or

(d) to prevent or limit other damage within the territory of the Member from the

entry, establishment or spread of pests.

Sanitary or phytosanitary measures include all relevant laws, decrees,

regulations, requirements and procedures including, inter alia, end product

criteria; processes and production methods; testing, inspection, certification and

approval procedures; quarantine treatments including relevant requirements

associated with the transport of animals or plants, or with the materials necessary

for their survival during transport; provisions on relevant statistical methods,

sampling procedures and methods of risk assessment; and packaging and

labelling requirements directly related to food safety.”

It is interesting to note how this provision does not define an SPS measure, but gives

the parameters as to in which cases a measure23

must be understood to be an SPS

measure.

The WTO Adjudicating Bodies have not been consistent when interpreting the extent

of SPS measures. The first position on this matter was adopted by the Panel in the EC –

Biotech case, where it was stated that in order to determine if a measure is an SPS

23

It is important to recall that the Appellate Body defined a measure within the WTO as: “In principle,

any act or omission attributable to a WTO Member can be a measure of that Member for purposes of

dispute settlement proceedings. (…) acts or omissions that are so attributable are, in the usual case, the

acts or omissions of the organs of the state, including those of the executive branch.” ABR, US –

Corrosion-Resistant Steel Sunset Review, para. 81.

16

measure, three elements must be examined: the purpose, the legal form and the nature.

“The purpose element is addressed in Annex A(1)(a) through (d) ("any measure

applied to"). The form element is referred to in the second paragraph of Annex

A(1) ("laws, decrees, regulations"). Finally, the nature of measures qualifying as

SPS measures is also addressed in the second paragraph of Annex A(1)

("requirements and procedures, including, inter alia, end product criteria;

processes and production methods; testing, inspection, certification and approval

procedures; [etc.]").”24

Regarding the purpose the Panel added that it must not be an express purpose but

that it “may be determined by the actual policy objective sought by a member”25

.

Regarding the other two elements, the Biotech Panel considered that a law, decree or

regulation is different from a requirement or procedure, and both of these last elements

must concur in order for a measure to be an SPS measure. Indeed, in regard to the first

group the Panel understood that they are elements of the form, i.e. the kind of act they

constitute, while the second belong to the nature, i.e. the object of the measure itself.

Hence, under this interpretation, an SPS Measure would be a law, decree or regulation

that sets a requirement or procedure aimed at the protection of human, animal or plant

life or health under the hypotheses of Annex A1 (a) through (d).

This approximation to SPS measures was followed by the Panel in the case US –

Continued Suspension, which examined the measure at issue under the EC – Biotech

test26

.

The Panel in the US – Poultry dispute undertook again the study of the determination

24

PR, EC – Biotech, para. 7.149. 25

PR, EC – Biotech, para. 7.2558. 26

PR, US – Continued Suspension, para. 7.429.

17

of SPS measures. The Panel required the parties to that dispute (China as complainant

and the US as respondent) to express their views on the three-step test set by Biotech.

China’s allegation was that interpreting Annex A1 in a correct manner would exclude

the existence of the “nature element”, whilst the US considered the element as

necessary. The Panel gave the reason to China arguing that the US failed to explain how

the “nature element” should be understood, and to show therefore, why the Biotech test

had to be followed27

. It further explained:

“The Panel has carefully examined the panel's findings in EC Approval and

Marketing of Biotech Products as regards the legal basis for distinction of "form"

and "nature" and has difficulty with following the reasoning. The rationale for

dividing the phrase "laws, decrees, regulations, requirements and procedures

including...," into "form" and "nature" is not clear to us as the panel did not

elaborate on this point. The panel did not explain how "requirements and

procedures" were somehow fundamentally different from "laws, decrees,

regulations" or why it believed that all SPS measures somehow have the nature of

a "requirement" or "procedure". If we examine the text of Annex A(1), we note

that there is no such separation and a plain reading might lead one to believe that

"requirements and procedures" are also descriptions of the possible types or

"forms" of an SPS measure while the substantive descriptions following

"including inter alia" are just illustrative examples of the types of SPS measures

Members have imposed”28

In this vein, the obscure difference between the “legal form” and the “nature” was

found incorrect, as the Poultry Panel understood that the latter is intrinsic to the former,

27

PR, US – Poultry, para. 7.95. 28

PR, US – Poultry, para 7.100.

18

and thus the determination of a measure as an SPS measure encompasses only the

purpose and the form29

.

This interpretation seems quite more accurate than the three part test set forth by the

Biotech Panel, since a measure can be a law, decree, regulation, requirement or

procedure independently, and not necessarily must one of the first three concur with one

of the last two. Besides, the three-pronged test developed by Biotech made it more

difficult for a measure to fall under the scope of the SPS Agreement, since not only

must the objective of the measure be demonstrated, but also two different “form”

requirements. The Poultry solution is more flexible and inclusive, giving more meaning

to the SPS Agreement.

Therefore, for a measure to be an SPS measure, according to the WTO case law, it

only needs to be a law, decree, regulation, requirement, procedure, etc., with the

purpose of protecting human, animal or plant life or health under the cases set by Annex

A1 (a) through (d) of the SPS Agreement.

29

PR, US – Poultry, paras. 7.101-7.102.

19

2. THE GENERAL SCIENTIFIC OBLIGATION OF ARTICLES 2.2 AND 5.1 OF

THE SPS AGREEMENT

The SPS Agreement develops the Basic Rights and Obligations in Article 2 and the

Assessment of Risk and Determination of the Appropriate Level of Sanitary or

Phytosanitary Protection in Article 5. Together with Article 5.7, which will have a

section of its own, they form the general scientific obligation of the SPS Agreement.

Each provision will be analyzed separately.

a. ARTICLE 2.2 AND ITS INTERPRETATION

As was highlighted previously, Article 2 of the SPS Agreement is entitled Basic

Rights and Obligations. Referring to the scientific obligation, regard must be had to the

second part of this provision. Article 2.2 states:

“Article 2

Basic Rights and Obligations

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.”

According to the Panel in EC – Biotech Article 2.2 sets three requirements that must

be met by SPS measures: “(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

20

measures not be maintained without sufficient scientific evidence.”30

The Appellate Body in the case Japan – Agricultural Products II confirmed the

Panel’s ruling in the same dispute when interpreting that Article 2.2 requires a “rational

or objective relationship between the SPS measure and the scientific evidence”31

. That

qualified relationship between the measure at issue and the scientific information is

what will limit the necessity of the measure, and whether or not it is consistent with

Article 2.2.

In addition to this, the Appellate Body also stated:

“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

The Appellate Body in Japan – Apples also used this approximation when examining

Article 2.2. In that dispute, the Panel analyzed the measure and the risks through a

procedure of breaking the measure into steps and studying those independently. Upon

appeal the Appellate Body made clear that:

“[T]he approach followed by the Panel in this case — disassembling the

sequence of events to identify the risk and comparing it with the measure — does

not exhaust the range of methodologies available to determine whether a measure

is maintained ‘without sufficient scientific evidence’ within the meaning of Article

2.2. Approaches different from that followed by the Panel in this case could also

prove appropriate to evaluate whether a measure is maintained without sufficient

30

PR, EC – Biotech, para. 7.1424. 31

ABR, Japan – Agricultural Products II, para. 84. 32

ABR, Japan – Agricultural Products II, para. 84.

21

scientific evidence within the meaning of Article 2.2. Whether or not a particular

approach is appropriate will depend on the ‘particular circumstances of the

case’.”33

In this vein, it has been established that SPS Article 2.2 has no specific test or

requirement for the analysis of consistency between the obligation contained in it and

the measure at issue, giving total freedom to the parties of a dispute to prove eventual

consistency or violations.

(i) Sufficient Scientific Evidence

As it is evident from the wording of Article 2.2 of the SPS Agreement, a measure

must be based on sufficient scientific evidence in order for it to comply with this

provision of the Agreement. The Appellate Body in Japan – Agricultural Products II,

studied the meaning of sufficient, deciding that it is a relational concept reaching the

conclusion of the necessity of an objective, rational relationship discussed above34

.

The meaning of scientific evidence needed clarifying in order to define the extent of

the term. The Appellate Body in Japan – Apples decided that:

“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

(…)

33

ABR, Japan – Apples, para. 164. 34

ABR, Japan – Agricultural Products II, para. 73.

22

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.”35

(Underlining not in the original text)

Furthermore, the Appellate Body also accepted that the evidence could be direct or

indirect, whether it does or does not directly prove a certain fact. Both kinds are

acceptable, but the probative value of the first one is higher in the eyes of the

Adjudicating Bodies36

.

(ii) Burden of Proof

The burden of proof in Article 2.2 of the SPS Agreement has been interpreted in a

very peculiar manner. The subject of the burden of proof will be analyzed with more

depth later in this paper37

, since it will be the central topic in the assessment of the legal

nature of SPS Article 5.7, one of the key debates within the general scientific obligation

of the SPS Agreement. Nevertheless, certain precisions are in order in the present

topic38

.

In Japan – Agricultural Products II, the Panel understood that the burden of proving

inconsistency with Article 2.2 was of the claimant, the United States. The US was

alleging that Japan had imposed measures not based on sufficient scientific evidence on

8 different varietals. However, the US only brought information on 4 of them. The

35

ABR, Japan – Apples, paras. 8.92-8.93. 36

ABR, Japan – Apples, para. 8.98. 37

See Infra Section 3(c) (i). 38

According to professor Matsushita, the burden of proof “concerns the issue of which of the disputing

parties is responsible for proving the illegality or legality of the conduct under question” Matsushita, pg.

125.

23

Panel understood that the claimant had not proved inconsistency with Article 2.2

regarding the other four products. Upon appeal, the United States argued that the Panel

had set upon it an impossible burden, since there was no scientific evidence available

for those products. The Appellate Body understood that there was no such situation:

“[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.”39

This presumption is not quite clear. The Appellate Body established that if the US

had exhorted Japan to show the evidence that led them to adopt the challenged

measures, and Japan had failed to do so, that would have raised a “strong indication

that there are no such studies or reports”40

. That would have been the presumption that

the Appellate Body referred to.

The Panel had the opportunity to refer to this subject again in Japan – Apples:

“Japan argues, that, in order for the United States to establish a prima facie case

under Article 2.2, it has to positively prove the ‘insufficiency’ of scientific

evidence. The United States claims that there is simply no scientific evidence

supporting the measure at issue. Under these circumstances, and in application of

the reasoning of the Appellate Body in Japan — Agricultural Products II, we

consider that the United States should raise a presumption that there are no

39

ABR, Japan – Agricultural Products II, para. 137. 40

Ibidem.

24

relevant scientific studies or reports in order to demonstrate that the measure at

issue is not supported by sufficient scientific evidence. If Japan submits elements

to rebut that presumption, we would have to weigh the evidence before us.”41

Hence, the theory of the presumption of no relevant information is available for a

claimant and fulfills its burden of proof.

The Appellate Body in EC – Hormones reversed the Panel’s ruling on the burden of

proof in the SPS Agreement, and explained:

“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 case42

is made, the burden of proof

moves to the defending party, which must in turn counter or refute the claimed

inconsistency. This seems straightforward enough and is in conformity with our

ruling in United States - Shirts and Blouses43

, which the Panel invokes and which

embodies a rule applicable in any adversarial proceedings.”44

The Appellate Body made clear that the general rule of the burden of proof is the one

applicable to the SPS Agreement.

From the analysis of Article 2.2 of the SPS Agreement it is possible to conclude that:

There must be an objective, rational relationship between the measure and the

scientific evidence that was used to adopt it.

There is no test or procedure to prove consistency with Article 2.2, and must

41

PR, Japan – Apples, para. 8.106. 42

See infra fn. 85. 43

The Appellate Body Report in US – Wool Shirts and Blouses is the landmark case in the topic of the

burden of proof. Its analysis and implications will be explained in detail later in this paper. 44

ABR, EC – Hormones, para. 98.

25

be analyzed on a case-by-case basis.

Scientific Evidence includes direct or indirect data obtained through the

scientific method, excluding unsubstantiated data and non-proven

hypotheses.

The general rule on the burden of proof (it corresponds to the claimant to

prove the alleged inconsistency) is applicable. However, there is a

“presumption” raised when the claimant affirms there are no relevant reports

or studies. The burden will then shift to the respondent to show that they

exist.

b. ARTICLE 5.1 AND ITS INTERPRETATION

Article 5.1 of the SPS Agreement imposes a particular obligation on Members,

where by it sets the conditions of how they must handle and present the information that

serves as a basis for an SPS measure:

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

on an assessment, as appropriate to the circumstances, of the risks to human,

animal or plant life or health, taking into account risk assessment techniques

developed by the relevant international organizations.”

Firstly, the concept of risk must be addressed. The SPS Agreement brings no

definition as to what risk entails, leaving the concept with a lack of clarity. However,

Professor Matsushita, when referring to risk assessments under the SPS Agreement,

gives an approach to risk as “the likelihood that something might happen assuming

certain hypotheses”45

.

Nevertheless, the SPS Agreement did include an express definition of risk

45

Matsushita, p. 511.

26

assessment in paragraph 4 of Annex A:

“Risk assessment - The evaluation of the likelihood of entry, establishment or

spread of a pest or disease within the territory of an importing Member according

to the sanitary or phytosanitary measures which might be applied, and of the

associated potential biological and economic consequences; or the evaluation of

the potential for adverse effects on human or animal health arising from the

presence of additives, contaminants, toxins or disease-causing organisms in food,

beverages or feedstuffs.”

(i) General Requirements of Risk Assessments

Regarding risk assessments, case law has interpreted the SPS Agreement with the

intention to clarify the topic. Several important rules have risen from the Adjudicating

Bodies’ interpretations:

The first and most important statement made by the WTO Adjudicating Bodies

touches the procedural aspect of the risk assessment. In their view, the risk assessment

is to be carried out by the Member imposing or adopting the SPS measure, it is not a

burden or obligation of panels to conduct their own assessment when analyzing the

consistency of measures with the SPS Agreement46

. Therefore, the Member must

present the pertinent risk assessment to the Adjudicating Bodies, since they will not,

albeit possessing the information, carry out the necessary risk assessment.

Moreover, the Appellate Body has maintained that there is no specific methodology

that a Member must follow in order to conduct a risk assessment. Nevertheless, it did

establish that the risk assessment must take into account the possibility that other

46

PR, EC – Hormones, paras. 8.101, 8.104; PR, Australia – Salmon, para. 8.41; PR, Japan – Agricultural

Products II, para. 8.32.

27

measures exist different from the one adopted, that still are effective to protect life and

health. Basically, the Appellate Body denies the possibility that the risk assessment

becomes a tool for justifying a measure already applicable by stating that:

“[t]he evaluation contemplated in paragraph 4 of Annex A to the SPS Agreement

should not be distorted by preconceived views on the nature and the content of the

measure to be taken; nor should it develop into an exercise tailored to and

carried out for the purpose of justifying decisions ex post facto.”47

The second important rule is the existence of an objective relationship. Article 5.1

also uses the words “based on” which are present in Article 2.2. This situation led to

the conclusion that a rational, objective relationship is necessary as well between the

risk assessment and the measure adopted48

. The objective relationship has to be

analyzed “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”49

.

Thirdly, it has been recognized that conducting a risk assessment is difficult and

expensive. Therefore Appellate Body established:

“Article 5.1 does not insist that a Member that adopts a sanitary measure shall

have carried out its own risk assessment (…) The SPS measure might well find its

objective justification in a risk assessment carried out by another Member, or an

international organization”50

.

Hence, recourse may be had to an already conducted risk assessment in order for a

47

ABR, Japan – Apples, para. 208. 48

ABR, EC – Hormones, paras. 193-194. 49

ABR, Japan – Agricultural Products II, para. 84. 50

ABR, EC – Hormones, para. 190.

28

Member to adopt an SPS measure.

Fourthly, the Appellate Body in that same case understood that a risk assessment

could gather both the “mainstream” scientific opinion and the divergent, less shared

opinion in a specific situation. SPS measures can be based on any of them, and the fact

that a measure is based on the divergent minority does not make them inconsistent with

the SPS Agreement. A measure can have its base on a divergent opinion, and still have

a rational, objective relationship as required by the SPS Agreement51

.

Finally, and as a fifth interpretation, the Hormones case also shed light on the

concept of ascertainable risk. The Panel report in that case established, with aid of the

scientist that it sought for help, that there would always be an inherent risk in any

situation since science can never give definitive answers52

. These types of risks that are

a consequence of scientific uncertainty are not the ones to be analyzed in a proper, SPS-

consistent risk assessment. The Appellate Body, in the appeal, explained that:

“[i]f a risk is not ascertainable, how does a Member ever know or demonstrate

that it exists? In one part of its Reports, the Panel opposes a requirement of an

"identifiable risk" to the uncertainty that theoretically always remains since

science can never provide absolute certainty that a given substance will not ever

have adverse health effects. We agree with the Panel that this theoretical

uncertainty is not the kind of risk which, under Article 5.1, is to be assessed.”53

The Appellate Body also stated that:

“It is essential to bear in mind that the risk that is to be evaluated in a risk

assessment under Article 5.1 is not only risk ascertainable in a science laboratory

51

ABR, EC – Hormones, para. 194. 52

PR, EC – Hormones, para. 8.152, 8.153. 53

ABR, EC – Hormones, para. 186.

29

operating under strictly controlled conditions, but also risk in human societies as

they actually exist, in other words, the actual potential for adverse effects on

human health in the real world where people live and work and die.”54

Nevertheless, the Appellate Body emphasized that no threshold or minimum level of

risk is needed in order to adopt a measure. There can be any level of risk identified, and,

as long as an objective relationship exists between the risk assessment and the SPS

measure, the measure is WTO-consistent55

.

(ii) The First Risk Assessment in Annex A 4

The Appellate Body in Australia – Salmon understood that Annex A 4 of the SPS

Agreement contains two different risk assessments that are “substantially different”56

.

These are separated in the provision itself by means of the semicolon and the word

“or”57

.

The first part of Annex A 4 of the SPS Agreement sets forth the first of the two risk

assessments, in the following terms:

“The evaluation of the likelihood of entry, establishment or spread of a pest or

disease within the territory of an importing Member according to the sanitary or

phytosanitary measures which might be applied, and of the associated potential

biological and economic consequences (…)”

The scope of application of this first type of risk assessment is limited to risks arising

from pests or diseases.

54

ABR, EC – Hormones, para. 187. 55

ABR, EC – Hormones, para. 186. 56

ABR, Australia – Salmon, fn. 69. 57

The division of the two types of risk assessments follows the division of risks between “diseases and

pests” and “food-borne risk”.

30

In the Australia – Salmon case, the Panel concluded that:

“We further note that, in our view, three elements are contained in this definition

of risk assessment:

(1) the definition of risk assessment implies that the Member imposing the

sanitary measure first has to identify the disease(s) whose "entry, establishment or

spread" within its territory it wants to prevent as well as the "associated potential

biological and economic consequences";

(2) the definition then requires an "evaluation of the likelihood" of entry,

establishment or spread of these diseases and of the associated potential

biological and economic consequences"; and

(3) the definition further requires that the evaluation of the likelihood of entry,

establishment or spread of these diseases be conducted "according to the sanitary

... measures which might be applied".”58

What is characteristic of this particular risk assessment is the necessity to evaluate

the likelihood of the risk involved. Previous cases studied the definition and extent of

the likelihood requirement and all arrived to the conclusion that some degree of

probability is involved, rather than just the possibility of the risk occurring. In the report

on Australia – Salmon, the Appellate Body applied some “reverse engineering” to

assimilate the term likelihood to probability based on the findings of the EC –

Hormones case59

. Despite the fact that the Hormones case referred to the second type of

risk assessment, which will be analyzed shortly, it concluded that the term potential

58

PR, Australia – Salmon, para. 8.72. 59

“A proper risk assessment of this type must evaluate the ‘likelihood’, i.e., the ‘probability’, of entry,

establishment or spread of diseases and associated biological and economic consequences as well as the

‘likelihood’, i.e., ‘probability’, of entry, establishment or spread of diseases according to the SPS

measures which might be applied.” ABR, Australia – Salmon, para. 123 – 124

31

refers to possibility rather than probability60

, paving the way for the Salmon conclusion.

Later on, the panel in Japan – Apples established that the likelihood, understood as

probability, could be expressed in quantitative or qualitative terms.

The above leads to the conclusion that the first of the risk assessments contained in

Annex A 4 of the SPS Agreement is a matter of likelihood, of probability, which is the

key difference with the one to be analyzed immediately.

(iii) The Second Risk Assessment in Annex A 4

Unlike the first of the risks assessments, the second type contained in Annex A 4

does not involve likelihood, but only potential:

“(…) or the evaluation of the potential for adverse effects on human or animal

health arising from the presence of additives, contaminants, toxins or disease-

causing organisms in food, beverages or feedstuffs.” (Underlining not in the

original text)

The scope of application of this type of risk assessment is limited to health concerns

caused by certain substances in products that are ingested (food, beverages and

feedstuff).

The test for this risk assessment is apparently simpler than the previous one, since it

is a two-step process only:

“a risk assessment carried out in accordance with the SPS Agreement should (i)

identify the adverse effects on human health (if any) arising from the presence of

the hormones at issue when used as growth promoters in meat or meat products,

and (ii) if any such adverse effects exist, evaluate the potential or probability of

60

ABR, EC – Hormones, para. 184 and fn. 164.

32

occurrence of these effects.”61

Of course, the Appellate Body later specified the distinction between potential and

probability62

, but left the two-pronged test standing.

(iv) Conclusions regarding Article 5.1

It is possible to state, following the aforementioned, that Annex A 4 brings forth two

types of risk assessment, “[W]hile the second requires only the evaluation of the

potential for adverse effects on human or animal health, the first type of risk assessment

demands an evaluation of the likelihood of entry, establishment or spread of a disease,

and of the associated potential biological and economic consequences”63

.

From the analysis of Article 5.1 it is possible to conclude:

A risk assessment must be carried out according to the rules of Annex A 4 in

order for it to be a proper risk assessment.

The risks identified must be ascertainable, not merely theoretical, both in a

laboratory and in real-world conditions.

There must be an objective relationship between the risk assessment and the SPS

measure adopted. However, no minimum threshold or magnitude of risk is

required. That qualified relationship is to be studied on a case-by-case basis.

The risk assessment used to adopt a measure can take into account mainstream

scientific opinions, as well as divergent ones. There is no specific methodology

that must be used when conducting a risk assessment, so Members can choose

their own as long as it is an objective assessment and not just a justification of

an already adopted measure.

61

PR, EC – Hormones, paras. 8.98, 8.101. 62

See supra fn. 60. 63

ABR, Australia – Salmon, fn. 69.

33

The Member adopting the SPS measure must not conduct its own risk

assessment, but can use one conducted by another Member or international

organization.

Annex A 4 includes two different types of risk assessments, one that requires a

likelihood (probability) analysis of risk, and another one that only needs

potential (possibility).

c. RELATIONSHIP BETWEEN ARTICLES 2.2 AND 5.1 OF THE SPS AGREEMENT

As stated previously, three provisions comprise the “general scientific obligation” of

the SPS Agreement: SPS Articles 2.2, 5.1 and 5.7. Articles 2.2 and 5.1 have been

interpreted to have an intrinsic relationship of extreme closeness.

The Panel in EC – Hormones analyzed the two provisions as follows:

“According to Article 5.1, a Member needs to ensure that its sanitary measures

are based on an assessment of risks. The obligation to base a sanitary measure on

a risk assessment may be viewed as a specific application of the basic obligations

contained in Article 2.2 of the SPS Agreement”64

Upon appeal, the Appellate Body confirmed such interpretation:

“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.”65

That interpretation has not been changed by the Appellate Body and has been

64

PR, EC – Hormones, paras. 8.93, 8.96. 65

ABR, EC – Hormones, para. 180.

34

recalled in several other cases66

. This interpretation demonstrates that these two

provisions cannot be split, in the sense that they complement each other. The Appellate

Body in Australia – Salmon even concluded that a violation of Article 5.1 implies a

violation of Article 2.267

. The Panel in the US – Poultry dispute reaffirmed that

conclusion stating that:

“In our view, it would be preferable to start the analysis by looking at whether

Section 727 is based on scientific evidence, before examining how Section 727 is

applied. Accordingly, we will start by analyzing Articles 5.1, 5.2 and 2.2 of the

SPS Agreement. We will commence with Article 5.1 and 5.2 because any

inconsistency that the Panel finds with these provisions would by implication lead

to a finding of inconsistency with Article 2.2 of the SPS Agreement.”68

Hence, an SPS measure faces an exhaustive analysis regarding its compliance

with the general obligation of Article 2.2. Not only should a measure be analyzed

under that provision, but also because of its intrinsic relationship it must be read

together with Article 5.1. And in the event that it is found inconsistent with the latter,

then it would, by implication, violate Article 2.2 as well. So, in practice, a measure

could be challenged only under SPS Article 2.2 and be found inconsistent with that

obligation without ever being subject to its own analysis, if the measure is found to

be in violation of Article 5.1 previously.

66

ABR, Japan – Agricultural Products II, para. 75; PR, EC – Biotech, para. 7.1439; ABR, Australia –

Salmon, para. 130; PR, US – Poultry, para. 7.142. 67

“By maintaining an import prohibition on fresh, chilled or frozen ocean-caught Pacific salmon, in

violation of Article 5.1, Australia has, by implication, also acted inconsistently with Article 2.2 of the SPS

Agreement.” ABR, Australia – Salmon, para. 138. 68

PR, US – Poultry, para. 7.157.

35

3. THE SPECIAL CASE OF SPS ARTICLE 5.7

The third and final element of the general scientific obligation of the SPS Agreement

is Article 5.7. This provision is specifically mentioned in Article 2.2, in the following

terms:

“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.” (Underlining not in

the original text)

Hence, Article 5.7 comprises a situation that is not covered by the general obligation

of Article 2.2. Article 5.7 has been subject to broad interpretation by the WTO

Adjudicating Bodies, Article 5.7 is, without question, the source of the debates of the

general scientific obligation of the SPS Agreement.

a. ARTICLE 5.7 AND ITS INTERPRETATION

Article 5.7 of the SPS Agreement states:

“In cases where relevant scientific evidence is insufficient, a Member may

provisionally adopt sanitary or phytosanitary measures on the basis of available

pertinent information, including that from the relevant international organizations

as well as from sanitary or phytosanitary measures applied by other Members. In

such circumstances, Members shall seek to obtain the additional information

necessary for a more objective assessment of risk and review the sanitary or

phytosanitary measure accordingly within a reasonable period of time.”

Pursuant to the wording of Article 5.7 it seems clear that the measure adopted under

36

Article 5.7 must be provisional. Nevertheless, the Panel in EC – Biotech interpreted this

requirement in a different manner:

“The provisional adoption of an SPS measure is not a condition for the

applicability of Article 5.7. Rather, the provisional adoption of an SPS measure is

permitted by the first sentence of Article 5.7.

If the provisional adoption of an SPS measure had been intended as a condition

for the applicability of Article 5.7, the first sentence of Article 5.7 would, in our

view, have opened with a different phrase, such as "In cases where a Member

provisionally adopts an SPS measure [...]".”69

In this vein, a measure need not be provisional or set a time limit on its application

for it to fall under Article 5.7. It can be a permanent measure with unlimited

applicability as long as the following requirements, set forth by the Appellate Body in

Japan – Agricultural Products II, are fulfilled:

“Article 5.7 of the SPS Agreement sets out four requirements which must be met

in order to adopt and maintain a provisional SPS measure. Pursuant to the first

sentence of Article 5.7, a Member may provisionally adopt an SPS measure if this

measure is:

(1) imposed in respect of a situation where ‘relevant scientific information is

insufficient’; and

(2) adopted ‘on the basis of available pertinent information’.

Pursuant to the second sentence of Article 5.7, such a provisional measure may

not be maintained unless the Member which adopted the measure:

(1) ‘seek[s] to obtain the additional information necessary for a more objective

69

PR, EC – Biotech, paras. 7.2939-7.2940.

37

assessment of risk’; and

(2) ‘review[s] the … measure accordingly within a reasonable period of time’.

These four requirements are clearly cumulative in nature and are equally

important for the purpose of determining consistency with this provision.

Whenever one of these four requirements is not met, the measure at issue is

inconsistent with Article 5.7.”70

The “four cumulative requirements” have been used to study consistency with SPS

Article 5.7 in other cases as well71

. Each of the requirements will be analyzed

individually.

(i) Insufficient scientific information

The first of the four requirements is the one that narrows the scope of Article 5.7 and

links it to Article 2.2. The Appellate Body addressed sufficiency of information

indicating:

“‘relevant scientific evidence’ will be ‘insufficient’ within the meaning of Article

5.7 if the body of available scientific evidence does not allow, in quantitative or

qualitative terms, the performance of an adequate assessment of risks as required

under Article 5.1 and as defined in Annex A to the SPS Agreement. Thus, the

question is not whether there is sufficient evidence of a general nature or whether

there is sufficient evidence related to a specific aspect of a phytosanitary problem,

or a specific risk. The questions is whether the relevant evidence, be it ‘general’

or ‘specific’, in the Panel’s parlance, is sufficient to permit the evaluation of the

likelihood of entry, establishment or spread of, in this case, fire blight in

70

ABR, Japan – Agricultural Products II, para. 89. 71

ABR, Japan – Apples, para. 176; PR, EC – Biotech, para. 7.2973.

38

Japan.”72

There has to be an analysis that compares the available information present when

adopting an SPS measure, and the possibility of performing a risk assessment based on

that information. If the body of information is enough as to perform a risk assessment in

the terms of the SPS Agreement, then the measure cannot fall under the scope of Article

5.7. If, on the other hand, that available information does not allow the development of

a proper risk assessment, the SPS measure will follow Article 5.7. In the end what will

wind up determining the sufficiency of the information is the possibility of performing a

risk assessment. Furthermore, the Appellate Body also made clear that insufficient

information and scientific uncertainty are different concepts; while the first one is the

absence of enough data as to perform a risk assessment, the second refers to the

impossibility of knowing all the possible risks deriving from a situation. Article 5.7 is

only triggered by the insufficiency, not by the uncertainty73

.

(ii) Based on available pertinent information

The measure adopted must be based on the information that the members possesses,

albeit being insufficient as to perform a proper risk assessment. This specific

requirement has not been addressed by the WTO Adjudicating Bodies in further detail.

(iii) Seek to obtain additional information

The interpretation of this requirement is closely related to what has been said for the

first one. Information to be sought must be the one that can conduct to the elaboration of

a risk assessment. In the words of the Appellate Body:

“Article 5.7 states that the additional information is to be sought in order to allow

72

ABR, Japan – Apples, para. 179. 73

ABR, Japan – Apples, para. 184.

39

the Member to conduct ‘a more objective assessment of risk’. Therefore, the

information sought must be germane to conducting such a risk assessment”74

Therefore, the information that is missing in order for a proper risk assessment to

exist is the one that must be sought. The Appellate Body also made it clear that this

requirement does not impose that a certain result is obtained after seeking additional

data, only that the member does so75

.

(iv) Revision of the measure within a reasonable period of time

The final requirement of SPS Article 5.7 has been relatively peaceful in its

interpretation. The Appellate Body understood that a reasonable period of time is not

subject to a general rule, but it must rather be determined on a case-by-case basis taking

several factors into account “including the difficulty of obtaining the additional

information necessary for the review and the characteristics of the provisional SPS

measure”76

. In Japan – Agricultural Products II, for instance, the Appellate Body

upheld the Panel’s finding that two years were not a reasonable period of time to review

the measure.

Whenever a measure complies with these four requirements, the measure will be

consistent with SPS Article 5.7. The legal nature of Article 5.7 and its relationship with

Article 2.2 will be addressed in an upcoming section77

.

b. THE PRECAUTIONARY PRINCIPLE

In the Hormones dispute, the EC upheld that its measures were based on a proper

risk assessment as required by Article 5.7 of the SPS Agreement by stating that it had

74

ABR, Japan – Agricultural Products II, para. 92. 75

ABR, Japan – Agricultural Products II, para. 92. 76

ABR, Japan – Agricultural Products II, para. 93. 77

See infra Section 3 (c).

40

acted under the precautionary principle.

The precautionary principle is said to have its basis in the Rio Declaration on

Environment and Development of 1992, an environmental declaration, which states:

“Principle 15

In order to protect the environment, the precautionary approach shall be widely

applied by States according to their capabilities. Where there are threats of

serious or irreversible damage, lack of full scientific certainty shall not be used as

a reason for postponing cost-effective measures to prevent environmental

degradation.”

A communication by the European Union regarding this principle, in 2000, stated:

“The precautionary principle applies where scientific evidence is insufficient,

inconclusive or uncertain and preliminary scientific evaluation indicates that

there are reasonable grounds for concern that the potentially dangerous effects

on the environment, human, animal or plant health may be inconsistent with the

high level of protection chosen by the EU.”78

Hence, the argument of the EC was that a proper risk assessment and scientific

information had been used as a basis for their measure, using a precautionary approach

based on the aforementioned principle. The Panel understood that the precautionary

principle finds development in SPS Article 5.7, and therefore cannot override the

obligations of Articles 5.1 and 5.2. Since the EC did not invoke Article 5.7, the measure

could not have been based on a proper risk assessment79

.

78

World Commission on the Ethics of Scientific Knowledge and Technology COMEST, The

Precautionary Principle, UNESCO: 2005. 79

PR, EC – Hormones, paras. 8.157-8.158.

41

Upon appeal, the EC upheld that the principle has to be considered a customary rule

of international law, or at least a principle of international law in the sense of actually

being a source of law. The United States and Canada argued that the status of source of

international law was not yet achieved by the precautionary principle, but it is rather an

emerging principle or just an approach80

.

The Appellate Body then decided not to address the matter of the legal status of the

principle, considering that “it is unnecessary, and probably imprudent, for the Appellate

Body in this appeal to take a position on this important, but abstract, question”81

. It did

conclude, however, the following:

“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. Secondly, the

precautionary principle indeed finds reflection in Article 5.7 of the SPS

Agreement. (…) Thirdly, 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. 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

80

ABR, EC – Hormones, paras. 121-122. 81

ABR, EC – Hormones, para. 123.

42

Agreement.”82

Hence, it gave the Panel the reason when stating that the obligations of Articles 5.1

and 5.2 cannot be overridden by invoking the precautionary principle, and that the

relevant provision when assessing precautionary action is Article 5.7, being the one

under which scope fall situations of scientific insufficiency.

The EC got the chance to bring the discussion to life again in the Biotech dispute. It

argued that Genetically Modified Organisms (“GMO’s”) could pose risks to life and

health and, therefore, on the basis of an internationally recognized principle, it took

precautionary action. The United States, once again stated that precaution is an

approach and not a principle of international law and, obviously, quoted the Appellate

Body’s report on EC – Hormones. Canada and Argentina, complainants in the case

along with the US, followed the same line of defense83

.

The Panel recalled the Hormones decision and understood that the precautionary

principle had not been demonstrated to be a general principle or customary rule of

international law, seemed almost exclusive to environmental law, and not even could

the doctrine agree on its extent. It concluded that “[S]ince the legal status of the

precautionary principle remains unsettled, like the Appellate Body before us, we

consider that prudence suggests that we not attempt to resolve this complex issue,

particularly if it is not necessary to do so”84

.

However, unlike the Hormones dispute, in this case Article 5.7 had been invoked,

and the EC argued precaution along with its measures that were based on that provision

of the SPS Agreement. The Panel, after recalling the Hormones interpretation of Article

82

ABR, EC – Hormones, para. 124. 83

PR, EC – Hormones, paras. 7.77-7.85. 84

PR, EC – Biotech, paras. 7.88-7.89.

43

5.7 as a reflection of the precautionary principle that could not override other

obligations of the SPS Agreement, decided that there was no need to independently

address the claim under the precautionary principle and under Article 5.785

. The report

on Biotech was not appealed, and so the Appellate Body has not reviewed the

precautionary principle after it did in Hormones86

.

Taking all into account, it is safe to say that the nature of the precautionary principle

is still in debate, as well as its application. Article 5.7 has been the provision selected to

somehow encompass it in the world of WTO. Nevertheless, we shall address the

precautionary principle again later in this document.

c. THE NATURE OF SPS ARTICLE 5.7

As was previously stated, Article 2.2 of the SPS Agreement establishes that it applies

“except as provided for in paragraph 7 of Article 5”. The Appellate Body in Japan –

Agricultural Products II, approached the implications of this wording where it stated

that:

“[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

85

PR, EC – Biotech, para. 7.3220. 86

The Appellate Body’s only “post-Hormones” addressing of the matter came in the Agricultural

Products II report, where it only recalled that the precautionary principle could not override SPS

obligations. See ABR, Japan – Agricultural Products II, para. 81.

44

of that obligation would render Article 5.7 meaningless.”87

(Underlining not in

the original text)

The Appellate Body’s interpretation suggests that it purposefully did not use the

word exception to define Article 5.7, despite the word except appearing in the text of

Article 2.2. This interpretation has key importance in the topic of the burden of proof,

for exemptions and exceptions have completely opposite applicable rules in that field.

(i) Burden of proof

The fact that the word exemption was the one chosen by the Appellate Body rather

than the very similar exception has practical implications regarding the burden of proof.

The burden of proof “concerns the issue of which of the disputing parties is responsible

for proving the illegality or legality of the conduct under question”88

. The Appellate

Body on US – Wool Shirts and Blouses established:

“[i]t is a generally- accepted canon of evidence in civil law, common law and, in

fact, most jurisdictions, that the burden of proof rests upon the party, whether

complaining or defending, who asserts the affirmative of a particular claim or

defence. If that party adduces evidence sufficient to raise a presumption that what

is claimed is true, the burden then shifts to the other party, who will fail unless it

adduces sufficient evidence to rebut the presumption.”89

Then, the general principle of the burden of proof is: whoever asserts, either as a

claim or as a defense, has the burden of proving that what it is asserting. If what is

asserted is, in fact, proved, then the burden shifts to the other party so it can, in the

terms set above, rebut the presumption made by its counterparty. This is what is called a

87

ABR, Japan – Agricultural Products II, para. 80. 88

Matsushita, pg. 125. 89

ABR, US – Wool Shirts and Blouses, pg. 14.

45

prima facie case90

.

The Panel in Turkey – Textiles summarized the previous interpretation as follows:

“(a) it is for the complaining party to establish the violation it alleges;

(b) it is for the party invoking an exception or an affirmative defence to prove

that the conditions contained therein are met; and

(c) it is for the party asserting a fact to prove it.”91

How does this situation affect SPS Article 5.7? When invoking exceptions, it is the

responding party who asserts the affirmative (i.e., “the measure is covered by the

exception”) and not the complainant, which, in any case, would only assert the negative

(i.e., “the measure is not covered by the exception”). Hence, the burden of establishing a

prima facie case would rest on the respondent, who would have to prove it complies

with the exception invoked92

.

So, when categorizing Article 5.7 not as an exception, then the burden of proof

would rest on the complaining party, at least in principle.

(ii) Treatment of the nature and burden of proof of Article 5.7.

After the Japan - Agricultural Products II seemingly interpreted Article 5.7 in a clear

fashion, case law has some confusing decisions on the matter. First, it was the Panel, in

an issue not appealed, in the Japan – Apples dispute. Japan argued that the measure at

issue was indeed based on scientific evidence as required by Article 2.2 of the SPS

Agreement. However, it argued that in case that the Panel found that the measure was

not maintained with sufficient scientific evidence, then it complied with the

90

“a prima facie case is one which, in the absence of effective refutation by the defending party, requires

a panel, as a matter of law, to rule in favour of the complaining party presenting the prima facie case.”

ABR, EC – Hormones, para. 104. 91

PR, Turkey – Textiles, para. 9.57. 92

See: Matsushita, pg. 127.

46

requirements of Article 5.7 and thus was exempted from the obligation of Articles 2.2

and 5.1. The Panel accepted this argument and established that:

“[a]rguing in the alternative is a well-established judicial practice and arguing a

point in the alternative of another point often implies that there may be some

contradictions between the two lines of argumentation if they were presented

concurrently.

In this instance, we have determined above that Japan’s measure is maintained

without sufficient scientific evidence within the meaning of Article 2.2, which is

the circumstance in which Japan invokes Article 5.7”93

Although the Panel is correct when it states that the possibility of alternative claims

exists, it is still confusing as to how can a measure be based on sufficient information

but, at the same time, taken under the requirements imposed whenever there is not

sufficient information. The Panel continued its idea stating that:

“We will therefore now consider whether the measure at issue can be justified as

a provisional measure within the meaning of Article 5.7 of the SPS Agreement.

Before doing so, however, we find it relevant to recall that the burden is on

Japan, as the party invoking Article 5.7 to make a prima facie case in support of

its position.”94

So what the Panel actually did was imposing the burden of proof on Japan, the

respondent, since it was the party invoking the provision. But if Article 5.7 is an

exemption and so the burden of proving is on the complainant’s shoulders, wouldn’t it

have sufficed for Japan to show that the measure had to be analyzed under Article 5.7

93

PR, Japan – Apples, paras. 8.210-8.211. 94

PR, Japan – Apples, para. 8.212.

47

without having to prove consistency? Japan could have only stated that there was,

indeed, insufficient evidence and that the complainant invoked the wrong provision.

That said, it would have been enough to establish that the burden of proving a violation

of Article 5.7, being an exemption, was on the claimant and, since the wrong provision

had been invoked (Articles 2.2 and 5.1), it never raised a prima facie case.

Notwithstanding the aforementioned, the Panel understood that, exemption or not,

the party alleging the provision had to demonstrate it complied with it.

After the Apples case, the issue rose again in EC – Biotech where the Panel did ask

the question of the nature of Article 5.7. The Panel first applied a “test” present in the

Appellate Body report on EC – Tariff Preferences, which states:

“In cases where one provision permits, in certain circumstances, behaviour that

would otherwise be inconsistent with an obligation in another provision, and one

of the two provisions refers to the other provision, the Appellate Body has found

that the complaining party bears the burden of establishing that a challenged

measure is inconsistent with the provision permitting particular behaviour only

where one of the provisions suggests that the obligation is not applicable to the

said measure. Otherwise, the permissive provision has been characterized as an

exception, or defence, and the onus of invoking it and proving the consistency of

the measure with its requirements has been placed on the responding party.”95

The Panel then applied this test to Articles 2.2 and 5.7 and found that:

“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 [namely,

95

ABR, EC – Tariff Preferences, para. 88.

48

Article5.7] 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 measure 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 measure 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.”96

The Panel, after this interpretation, reaffirmed that Article 5.7 is not an exception to

the obligation of Article 2.2 (and, in connection, Article 5.1). But it did add that Article

5.7 is a right and that Article 2.2 excludes the situations covered by Article 5.7.

These topics, as well as the nature of Article 5.7 will be analyzed further in this

96

PR, EC – Biotech, paras. 7.2968-7.2969.

49

document, along with an attempt to present a solution to the confusion surrounding it97

.

However, from what was previously established we can conclude that:

Article 5.7 is a special case where the obligation of Articles 2.2 and 5.1 does

not apply.

In order to comply with Article 5.7 of the SPS Agreement four cumulative

requirements must be met.

Article 5.7 is not an exception to Articles 2.2 and 5.1, and therefore the

general rule on the burden of proof applies.

97

See infra Section 5 (c).

50

4. OVERALL VIEW OF THE GENERAL SCIENTIFIC OBLIGATION OF THE

SPS AGREEMENT

As it has been stated, the SPS Agreement contains its “general scientific obligation”

in Articles 2.2, 5.1 and 5.7. The first two acting as inseparable in nature, while the third

one acts as a complement to the rule of the other two, in a single special case. From all

of the explained previously, it is possible to extract the general overview of the general

scientific obligation of the SPS Agreement, in order to identify the extent of the general

scientific obligation, the main purpose of this paper.

It is clear now that the SPS Agreement seeks that SPS measures adopted by WTO

Members have an objective, scientific basis that can reasonably support the adopted

measure, despite the fact that it can restrict international trade. Hence, as long as a

measure that falls under the SPS Agreement’s scope is consistent with its obligations,

no matter if it is trade restrictive, it is WTO compliant.

When considering the consistency of a measure with the SPS Agreement, the first

analysis that it must undergo is whether or not it falls under the scope of the SPS

Agreement. The requirement for this to happen have been considered previously, and

present in Article 1.1 of the Agreement, which are (i) that the measure is an SPS

measure and (ii) that it has the potential to affect international trade. Furthermore, in

order for a Measure to be an SPS measure it must (i) follow one of the purposes listed in

Annex A 1 (a) through (d) and (ii) have one of the legal forms listed in the second

paragraph of Annex A 1. As explained previously, this “introductory step” to the

analysis is not always peaceful, as was seen in the EC – Biotech and US – Poultry

51

disputes98

.

Once the measure is found to fall under the scope of the SPS Agreement, the

provisions of the general scientific obligation become applicable. First, it is necessary to

conduct the analysis of consistency with Article 2.2. The measure must be adopted on

the basis of “scientific principles and is not maintained without sufficient scientific

evidence” as required by said provision.

That examination must be conducted with regards to what was previously analyzed,

that the scientific evidence serves as a basis for the measure (the existence of an

objective, rational relationship between the two) and that the information is obtained

through the scientific method (unsubstantiated evidence and non-proved hypotheses are

not available)99

.

Additionally, the scientific information that serves as a basis for the measure at issue

must be developed and organized in a risk assessment that follows the definition of

Annex A 4, as required by Article 5.1. Since Articles 2.2 and 5.1 have been interpreted

to be related and “should constantly be read together”100

, failure to comply with the

requirements of a risk assessment implies not only the violation of Article 5.1 but also a

violation of Article 2.2101

.

If the measure is found consistent with the SPS Agreement, it raises a presumption of

compliance with GATT (especially Article XX(b)) as recognized by SPS Article 2.4. If,

on the other hand, the measure is found to be inconsistent with Articles 2 and/or 5 of the

SPS Agreement, it cannot be justified under GATT Article XX(b), according to the

98

See supra Section 1 (b) (iii). 99

See supra Section 2 (a). 100

See supra fn. 65. 101

See supra Section 2 (c).

52

Panel in the US – Poultry case102

.

There is, however, a second possibility. The SPS measure can be adopted in a

situation where sufficient scientific information is not available, and therefore it results

impossible to conduct a proper risk assessment. This is the case contained in Article 5.7,

which renders the obligations of Articles 2.2 and 5.1 inapplicable. It is an exceptional

provision triggered only by a special scenario. Whenever a measure is adopted under

Article 5.7, it must comply with four cumulative requirements: (i) the measure must be

adopted whenever there is insufficient scientific information, (ii) it must be adopted on

the basis of the available pertinent information, (iii) the Member adopting it must seek

to obtain the additional information needed to develop a risk assessment, and (iv) the

measure must be reviewed within a reasonable period of time103

.

Three outcomes are possible after such analysis. Firstly, if it is found that the

measure is consistent with the requirements of Article 5.7 of the SPS Agreement, then it

cannot be analyzed under Articles 2.2 and 5.1 since they are not applicable to said

measure. The second possibility is that the first requirement of Article 5.7 is not met,

meaning that there is sufficient scientific information. In that event, the provisions that

must be taken into account are SPS Articles 2.2 and 5.1, which rule the cases of

sufficiency of information, and therefore Article 5.7 becomes inapplicable. The third

option is that where the second, third or fourth requirements of Article 5.7 are not met.

In that situation, Article 5.7 continues as the applicable provision since there is

insufficient scientific information, excluding Articles 2.2 and 5.1, but the measure will

be found inconsistent with SPS Article 5.7.

The aforementioned is the general panorama of the general scientific obligation of

102

See supra fn. 16. 103

See supra Section 3 (a).

53

the SPS Agreement as it stands to date. Interpretations by Panels and the Appellate

Body have shaped the extent of the general scientific obligation, while leaving several

points still open for debate. These, the three point included in the introduction, are

subject to analysis in the following chapter.

54

5. KEY ISSUES OF THE GENERAL SCIENTIFIC OBLIGATION OF THE SPS

AGREEMENT

The interpretation of the provisions of the general scientific obligation of the SPS

Agreement has been all but peaceful. As was shown before, doctrine and case law have

different, sometimes contradictory, opinions on certain topics in this matter, which aids

the fact that the extent of the general scientific obligation is ever-changing. This section

will develop three points of high importance: (i) the rigorousness of the general

scientific obligation, (ii) the applicability of the precautionary principle, and (iii) the

nature of SPS Article 5.7.

The first point is of great relevance since it shows how the general scientific

obligation, in seeking transparency, has imposed a heavy burden on states when

adopting SPS measures. The second has been relevant since the EU based its defense

invoking this principle, without obtaining a final answer on its applicability by WTO

adjudicating bodies. The third and final point has been recurrently problematic, since

Article 5.7 has been understood to be anything, from a right to an exception.

a. DOES THE SPS AGREEMENT ESTABLISH A PARAMETER TOO RIGOROUS FOR SPS

MEASURES?

As was stated earlier, the purpose of the SPS Agreement was to create objective

parameters in order to permit, under a scientific basis, the adoption of otherwise trade-

restrictive measures that seek to protect human, animal and plant life and health.

Nevertheless, observing the requirements and obligations contained in the SPS

Agreement, it seems that the standard set by it is too burdensome for Members.

As seen in the previous section, the general scientific obligation sets a high scientific

55

standard in order to base an SPS measure upon. Not only must the information be

obtained through the scientific method, and have a qualified relationship with the

measure it supports, but it also has to be organized as a risk assessment that evaluates

the risks, that must be identified particularly, and must take into account both

laboratory-based and real-world analysis of impact.

Upon the imposition of such a burden, it is not strange that in SPS-related disputes

the scope of application of the SPS Agreement has been a matter of conflict, as it was in

US – Poultry and EC – Biotech104

. In both of these cases, the defending party argued

that the measure at issue was not an SPS measure, trying to render the SPS Agreement

inapplicable105

. Moreover, the debates around the precautionary principle and the nature

of SPS Article 5.7 also find their basis on the rigor of the SPS Agreement.

Whatever defendants are invoking, be it a principle of international law, an

exception, or the source of the analysis (that the measure is not an SPS measure) the

intention is to exclude the heavy burdens of Articles 2.2 and 5.1. Finding an error in

data collection, risk assessment, objective relation with the measure, real-world risk

impact, evaluation of likelihood, etc., is highly probable and complainant-friendly. The

obligation of Articles 2.2 and 5.1 has so many details and requirements that complying

with it becomes extremely difficult. What happens in the end is that the residual,

exceptional situations become more “popular” than the general obligation. That is

exactly where the mentioned rigorousness takes a crucial role. It becomes preferable for

states adopting a measure that it is not an SPS-measure rather than be one.

The WTO case law has played its part in this problem, not only by building such a

104

See supra Section 1 (b) (iii). 105

In EC – Hormones the defending party tried to render the SPS Agreement inapplicable as well, not by

stating that the measure was not an SPS measure, but by arguing that the SPS Agreement should be

analyzed only if the measure at issue violated a GATT provision and was not justified by GATT Article

XX(b). See PR, EC – Hormones, pg. 13.

56

heavy burden on Articles 2.2 and 5.1, but also by (i) including a complex definition of

SPS measures, and (ii) interpreting that the SPS Agreement does not exhaust GATT

Article XX(b).

On one hand, the definition of SPS measures is way too complex. The measure must

follow a purpose of a convoluted list of threats and objectives that is not easy to

understand, besides including, in the last entry of that list, the concept of “other

damage”106

, which widens even more the indefinite scope of the Agreement.

If the SPS Agreement is supposed to be an elaboration of GATT Article XX(b), why

not simply state that the SPS Agreement is applicable to any measure “necessary to

protect human, animal or plant life and health”? That provision would reproduce

GATT Article XX(b) in its entirety and would Annex A 1 of the Agreement, the source

of debates regarding whether a measure is, or not, an SPS measure. Such a clause would

make it much more difficult to escape the boundaries of the SPS Agreement since the

technicality of the current wording of Annex A 1 allows member states to flee from the

applicability of the Agreement.

Indeed, the analysis that the SPS currently imposes is very complicated. There must

be a study of the diseases or pests to be prevented, as well as their effects for a measure

to be an SPS measures. Then, technicality permits debating the nature of the measure at

issue as SPS or non-SPS, shifting the analysis of the measure from its purpose to a fully

formal, textual analysis.

On the other hand, when the Appellate Body stated that Article XX(b) of GATT

encompassed both SPS measures as well as other types of measures107

, it allowed

Members to argue that a certain measure is necessary to protect life and health, as

106

See SPS Agreement Annex A 1 (d). 107

See supra fn. 17.

57

required to be justified by GATT Article XX(b), but at the same time that it is not an

SPS measure. This generates a terrible precedent since a measure not adopted on a

scientific basis, since it would not be an SPS measure, could end up being trade-

restrictive and with a life and health protection purpose, and still be justified by the

GATT exception. Certainly, if the Member defending the measure is able enough to

prove it does not fall within the complex definition of SPS measures, due to

technicality, it can show that it is nevertheless protected by GATT Article XX(b).

These two situations provide an “escape route” to the burdensome obligation of

Articles 2.2 and 5.1 that maybe would not raise threats if the SPS Agreement was more

compliant-friendly. The SPS should be constructed in a way that Members adopting

SPS measures would prefer to follow the rules of the SPS Agreement, rather than

seeking arguments to exclude its applicability.

This could be reached through two changes, (i) eliminating the automatic violation of

Article 2.2 by Article 5.1, and (ii) making Article 5.7 also applicable to cases of urgent

state action.

The first argument exposed tries to make the obligations of the SPS Agreement more

accessible by really creating two distinct obligations rather than what the Adjudicating

Bodies have understood to be one. If Articles 2.2 and 5.1 are understood as different,

independent obligations, then it is the burden of the complainant to show that a measure

is not based on a proper risk assessment and also not based on scientific information,

but not just the first one.

Then, it would be possible for a measure to be inconsistent with Article 5.1 but still

be based on scientific information. Hence, when a Panel or the Appellate Body

recommends that the measure be brought into conformity with WTO rules, the Member

58

will have the obligation to conduct the risk assessment, while maintaining the validity

of the information it used to adopt the measure. What happens under current

interpretation is that not only must the Member conduct a proper risk assessment, but it

also must seek for information since the one available is not enough as to base a

measure upon.

Therefore, splitting the obligations would make it easier for a defendant party to

comply with the SPS Agreement.

In the second place, Article 5.7 is, as was stated before, applicable whenever there is

insufficient scientific information as to perform a proper risk assessment. However, it

should be understood to encompass as well those cases where immediate state action is

necessary.

The SPS Agreement makes no distinction of situations of urgency and “normality”.

A Member must perform a risk assessment, as indicated by SPS Annex A 4, whenever

adopting an SPS measure irrespectively of the urgency it has to adopt it. But it seems

farfetched to require a proper risk assessment, with all the detail it entails, in cases

where a country is facing an emergency.

Opening Article 5.7 to urgent state action would permit Members to adopt SPS

measures more effectively, and would ensure that information is collected since, we

recall, in order to comply with SPS Article 5.7 a Member must seek to obtain additional

information as to perform a proper risk assessment and must review the measure within

a reasonable period of time. This would restrict Article 2.2, and 5.1, to circumstances of

normality, where performing a proper risk assessment is somehow easier, and would

allow states to protect life and health by recurring to an exceptional provision while it

takes the necessary time to comply properly with its SPS obligations.

59

Note how both suggested changes imply not a normative change in the text of the

Agreement, but on the interpretations of case law. This further confirms the fact that the

“leaks” in the text of the agreement have permitted case law to establish more

demanding requirements for compliance with the SPS Agreement

Finally, it is important to rescue the Appellate Body’s permission regarding the use

of risk assessments made by international organizations or other Members when

adopting an SPS measure. The burden of the general scientific obligation would have

been impossible to fulfill if the Appellate Body had understood that every Member

should conduct its own, independent risk assessment. However, a little more flexibility

could make the SPS more attractive to WTO Members, really fulfilling its goal of

objectivity in international trade108

.

The rigorousness of the general scientific obligation is counterproductive. Instead of

creating an agreement that sets conditions to enable the protection of life and health at

the stake of limiting free trade, the obligation has become a headache for adopting said

measures. Members should want their measures to fulfill the SPS Agreement with ease,

instead of trying to escape through technicalities.

b. IS THE PRECAUTIONARY PRINCIPLE COMPATIBLE WITH THE SPS AGREEMENT?

The second topic worthy of analysis is the standing of the precautionary principle in

WTO case law. As was seen previously, the WTO Adjudicating Bodies have already

made certain interpretations on the matter, however the question remains open.

The debate is born on the necessity of urgent state action. Since the SPS Agreement

108

As a matter of fact, one of the points in the Doha round agenda is the inclusion of “Equivalence”,

which is “putting into practice the principle that governments should accept that different measures used

by other governments can be equivalent to their own measures for providing the same level of health

protection for food, animals and plants.” See: The Doha Agenda at:

http://www.wto.org/english/thewto_e/whatis_e/tif_e/doha1_e.htm.

60

does not bring an exceptional provision for such cases, as it does in cases of insufficient

scientific information, then the general rule is applicable to situations of urgency.

Nevertheless, it seems impossible to require risk assessments and complex research data

in cases of emergencies. Therefore, the question is: if urgent state action is permitted

extraordinarily in environmental law, could it be applied in a WTO context? Could the

precautionary principle override the obligations of the SPS Agreement?

Decisions by Panels and the Appellate Body have already made clear that the

precautionary principle cannot override the obligations of the SPS Agreement, and that

the analysis of precautionary action was to be conducted along with Article 5.7109

.

The approach by these previous decisions is correct by interpreting that Article 5.7 is

a provision that reflects the precautionary principle. In that vein, it can be concluded

that whenever scientific information is insufficient, then Article 5.7 is triggered and the

obligation of Articles 2.2 and 5.1 is no longer applicable. It is a somewhat precautionary

provision. However, the problem lies in the triggering event of Article 5.7.

Suppose that a disease is starting to spread within a country. The government

believes that the disease is coming from imported food from a neighboring country. It

acts in a precautionary fashion and prohibits the imports coming from that suspected

country. Upon this decision, the measure is challenged in the WTO for being contrary to

the SPS Agreement. By acting with precaution and in a situation where there has not

been any risk assessment conducted, the defendant invokes Article 5.7, stating that it

acted without sufficient information. The problem would arise if the complainant

discovers that an international organization or a third country has already produced a

risk assessment on the matter. More so if the complainant conducts its own risk

109

See supra fn. 82.

61

assessment, showing that it was possible to do so. If so, scientific information was

sufficient, which means that Article 5.7 is not applicable, albeit the urgency of the

situation.

Then, notwithstanding urgent state action, the measure that seeks to protect life and

health from a rapidly spreading disease would have had to be adopted on the basis of a

risk assessment, even if time did not permit the necessary research.

Hence, it is possible to state that Article 5.7 reflects the precautionary principle in

cases of insufficient scientific information, but not when a precautionary measure is

enacted but scientific information is found to be enough as to perform a risk assessment.

Article 5.7 would more appropriately reflect the precautionary principle if its scope

was not only insufficiency of information, but emergency action as well.

As of today, the precautionary principle is of no direct application in SPS disputes.

But, is it possible to invoke it as a source of law? The EC tried to do so in the Hormones

and Biotech cases, and the Adjudicating Bodies did not venture to define its legal

nature. Moreover, the complainants in those cases argued that it does not comply yet

with the requirements for it to be considered a customary rule of international law nor a

principle of international law110

. It appears as if Article 5.7 has been interpreted as the

“precautionary provision” of the SPS Agreement, one that overrides the direct

applicability of the Rio Declaration’s principle.

It is important to recall that two panel decisions have recognized the secondary role

of customary international law and general principles of international law. In Korea –

Government Procurement the Panel established that a customary rule of international

law is binding to WTO Members only if there is no “contract out” within the Covered

110

See supra Section 3 (b).

62

Agreements111

. Article 5.7 of the SPS Agreement could be deemed as contracting out

from the terms of the customary rule of precaution.

On the other hand, principles help interpret sources of law, and “cannot substitute

for a detailed contractual provision”112

. The Panel in EC – Pipe Fittings understood

that a principle could not modify the existing burden of an obligation in a Covered

Agreement113

.

Recalling what was stated above, it appears that including the precautionary principle

in Article 5.7 of the SPS Agreement is not totally appropriate, and that more meaning

could be given to it if the scope of Article 5.7 was to be widened. The direct

applicability of the precautionary principle, by means of customary rules of

international law or general principles of international law, cannot be maintained.

c. ARTICLE 5.7: EXCEPTION OR EXEMPTION?

As was previously analyzed, the legal nature of SPS Article 5.7 has generated debate

in WTO dispute settlement. Various reports appear to address this provision in the terms

of a qualified exemption, others as a right, and, though not directly, it has also been

treated as an exception. The classification that suits Article 5.7 best is that of an

exemption. Nevertheless, it is not through complex tests and interpretations that such a

conclusion is met; rather, the nature of a provision is a question of applicability.

When facing exceptions or exemptions, two provisions must be present in the

analysis: the obligation that is supposedly being violated and the “extraordinary clause”

that is used as a defense. The real nature of a provision arises when an examination of

the provisions’ applicability is considered. Since an exception is a justification for the

111

PR, Korea – Government Procurement, para. 7.96. 112

Matsushita, pg. 81. 113

See: Ibidem; PR, EC – Pipe Fittings, para. 7.292.

63

violation of an obligation, it is logical that both provisions must be applicable at the

same time. The obligation must be complied with, but the measure at issue is violating

it, however the exceptional provision is justifying that violation.

A totally opposite situation arises with exemptions, where the two provisions cannot

be applicable at the same time, since they are triggered by different situations, making it

impossible for them to concur.

The case of Article 5.7 shows an exemption from the obligation of SPS Article 2.2

(and 5.1). Article 5.7 and Article 2.2 apply in different situations, the latter whenever

there is sufficient information and the former whenever it is insufficient. So both of

them will never be applicable at the same time, because either there is enough

information, or there is not enough information. Each provision simply refers to an

individual, independent scenario. Article 5.7 cannot be an exception since it does not

justify a measure inconsistent with Article 2.2, because whenever Article 5.7 results

applicable, the obligation of Article 2.2 cannot be expected to be fulfilled.

The Panel in EC – Biotech understood this relationship between the provisions when

stating that "Article 2.2 excludes from its scope of application the kinds of situations

covered by Article 5.7”114

. That relationship of exclusion is the basis for establishing

Article 5.7 as an exemption, which is more accurate than trying to apply the difficult test

of EC – Tariff Preferences115

. The conclusion of the Panel was different. Since the

Tariff Preferences test referred to rights and exceptions, the Panel did not change the

original language, and led to the interpretation that Article 5.7 is a right. The Panel

should have changed the language of the test it was using, since Article 5.7 had already

114

PR, EC – Biotech, paras. 7.2968-7.2969. 115

See supra fn. 88.

64

been defined as a qualified exemption116

before, as the Panel in Biotech had recalled. If

the Panel’s idea was to support the exemption conclusion, then it should have said so

explicitly after its analysis of exclusion between the provisions.

From the reading of the report in Japan – Apples, where Article 5.7 was first

characterized as an exemption, the same underlying rationale of applicability of

provisions can be found.

“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.”117

Hence, it appears that the relationship of exclusion present in Biotech was somehow

underlying the Appellate Body’s decision in the Apples case. Taking this into account, it

would have made perfect sense for the Biotech Panel to simply change the language of

its test, from right to exemption.

Besides, the term right is inappropriate as well since it carries an idea of choice,

which is not present in Article 5.7. This provision sets the parameters that must be

followed if a Member decides to adopt an SPS measure despite insufficiency of

scientific information. It is as much as an obligation as Article 2.2 (and 5.1) is in cases

where scientific information is sufficient.

“Indeed, in EC – Biotech, Canada correctly pointed out that this aspect of “free

choice” is absent in Article 5.7 whose application depends on a more objective or

116

See supra fn. 87. 117

ABR, Japan – Agricultural Products II, para. 80.

65

exogenous condition (if not purely so) – the absence of sufficient scientific

evidence.”118

Article 5.7, then, is not a right. Neither is it an exception since it does not justify a

violation of an applicable obligation. It is truly an exemption, since it removes,

excludes, from the scope of application of a certain provision (SPS Article 2.2) a special

situation that is to follow a different parameter for its adoption. Article 5.7 imposes the

true obligation to comply with it in the event that a Member pretends to adopt a measure

whenever scientific information is insufficient.

118

Broude, Tomer. Genetically Modified Rules: The Awkward Rule-Exception-Right Distinction in EC –

Biotech, International Law Forum of the Hebrew University of Jerusalem (2006).

66

6. CONCLUSIONS

The role of science in international trade, through the SPS Agreement, is of a high

importance since it is the tool that ensures objectivity. Through science it is really

possible to verify whether or not a trade restrictive measure responds to a life and health

concern rather than amount to a disguised restriction on international trade.

However, the SPS Agreement wound up being too objective-driven and science-

based, creating a difficult scenario for measures to be correctly adopted under its scope.

The general scientific obligation of the SPS Agreement created debates and complex

interpretations that are still well away from solutions.

Where do we stand on the question of the extent of the general scientific obligation

of the SPS Agreement? Today, we find an obligation that results very complicated to

comply with, since it imposes heavy requirements on SPS measure-adopting states.

Risk assessments, objective relations, likelihood and potential, and the rest of branches

that have grown from the wording of the SPS Agreement have imposed quite a burden

on WTO Member States.

The general scientific obligation is highly burdensome, which explains why the

requirements to comply with it are highly rigorous. Unless there is some flexibility in

the Agreement, it will continue to be preferable to escape through technicalities rather

than comply with its obligations.

Much deeper is the role that must be given to precautionary action in emergencies,

where expensive and thorough research is not viable. Still, those situations remain

untreated by the SPS Agreement, at least in an autonomous fashion. The debate will

arise whenever urgent state action is needed in situations of sufficiency of information,

and will shape the understanding of the SPS Agreement, surely changing current

67

interpretations.

Finally, the topic of the legal nature of SPS Article 5.7 remains open due to the

contradictions regarding its treatment and interpretations. As to what was concluded

regarding it, cataloguing it as an exemption continues to be the most accurate

interpretation, notwithstanding that a case could be made, correctly argued and through

the convoluted volume of precedent on the matter, that its nature is different.

While the Doha round of negotiations is scheduled to produce a revision of the SPS

Agreement, the WTO updates on the round contain no reference to an exhaustive

scrutiny of the provision that have been referred to in this paper. The Doha round’s

agenda is more focused on developing countries and trade topics, so these “academic”

considerations will likely continue to be developed in case law and doctrine119

.

For now, it is important to rescue the effort made by adopting this instrument,

considerably more appropriate that a one-sentence exception contained in GATT. The

SPS Agreement will probably be interpreted more and expanded in its considerations,

reaching a level of depth like the one GATT has obtained through the years. After all,

GATT has been subject to scrutiny since 1947, while the SPS Agreement has just been

around for 18 years.

119

See The Doha Agenda, at: http://www.wto.org/english/thewto_e/whatis_e/tif_e/doha1_e.htm.